Health Research Group Publications

Founded in 1971 by Sidney Wolfe, M.D. and Ralph Nader, Public Citizen’s Health Research Group promotes research-based, system-wide changes in health-care policy and drug safety. The work that we have done since 1995 is listed on this page in chronological order.

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2024

Letter to the FDA Commissioner Requesting an Investigation of the Conduct of Alzheimer’s Disease Trials (HRG Publication #2705)
Public Citizen requested a formal investigation of the conduct of clinical trials of two recently approved drugs for Alzheimer’s disease, lecanemab (Leqembi) and donanemab (Kisunla), and the actions of the institutional review boards with oversight over these studies.
[Created on 12/13/2024]

Testimony Before the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee Regarding Andexanet (Andexxa) (HRG Publication #2704)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Cellular, Tissue, and Gene Therapies Advisory Committee regarding andexanet (Andexxa), Public Citizen urged the FDA not to grant andexanet full approval because the ANNEXA-I postmarketing trial failed to verify a potential net benefit for the drug in acute intracerebral hemorrhage subjects who were treated with apixaban or rivaroxaban.
[Created on 11/21/2024]

Testimony before the FDA’s Center for Devices and Radiological Health Digital Health Advisory Committee Meeting (HRG Publication #2703)
In testimony before the FDA’s Center for Devices and Radiological Health Digital Health Advisory Committee meeting, Public Citizen urged the FDA to move forward with strong and comprehensive regulatory requirements for generative artificial intelligence (GenAI)-enabled devices. Although GenAI-enabled devices have potential to improve health, their risks are not fully known. There is justified concern that without robust oversight the risks of harms will substantially increase.
[Created on 11/21/2024]

Press Statement: FDA Slow to Ban Ineffective Over-the-Counter Oral Phenylephrine (HRG Publication #2702)
More than a year after an FDA advisory committee unanimously voted that the current dosage of oral over-the-counter phenylephrine is not effective for nasal congestion relief, the FDA finally issued a draft proposed rule to begin the process of removing the drug from shelves.
[Created on 11/8/2024]

Press Release: Dangerous Proposal Would Exempt Rare Disease Drugs from FDA Randomized Trial Requirement (HRG Publication #2701)
A forthcoming legislative proposal would allow the U.S. Food and Drug Administration (FDA) to approve drugs for rare diseases based on substantial evidence of effectiveness without randomized controlled trials, the “gold standard” process underlying drug approvals for decades.
[Created on 11/7/2024]

Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Sotagliflozin (HRG Publication #2700)
In testimony before the Food and Drug Administration’s (FDA’s) Endocrinologic and Metabolic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve sotagliflozin as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus and chronic kidney disease because there is a lack of substantial evidence demonstrating the effectiveness and safety of sotagliflozin in this population.
[Created on 10/31/2024]

Testimony before the FDA’s Pharmacy Compounding Advisory Committee about Hydroxyprogesterone Caproate (HRG Publication #2699)
In testimony before the FDA’s Pharmacy Compounding Advisory Committee, Public Citizen urged the committee to fully support the FDA’s recommendation to add hydroxyprogesterone caproate for the prevention of preterm birth to the list of drug products that were withdrawn or removed from the market for reasons of safety and effectiveness and therefore may not be compounded under the exemptions provided in FDA regulations. By a vote of 9-0, the committee supported the FDA’s recommendation.
[Created on 10/29/2024]

Press Release: Federal Officials Should Investigate Conduct of Alzheimer’s Disease Trials (HRG Publication #2698)
A disturbing New York Times article on Wednesday revealed that during clinical trials of two recently approved drugs for Alzheimer’s disease, participants were not told whether their genetic profiles increased their risks of brain injuries from receiving the drugs.
[Created on 10/23/2024]

Report: Ranking of the Rate of State Medical Boards’ Serious Disciplinary Actions, 2021-2023 (HRG Publication #2697)
This report examines the performance of state medical boards in protecting the public from dangerous physicians by disciplining doctor misconduct. Using state-level data on serious disciplinary actions from the National Practitioner Data Bank’s Public Use Data File, the report compares the performance of the state medical boards based on the number of serious disciplinary actions taken by the boards during the 2021-2023 period.
[Created on 10/4/2024]

Letter to the Inspector General of the Department of Health and Human Services requesting an Investigation of Conflict of Interest Allegations Against a Senior FDA Official (HRG Publication #2696)
Public Citizen requested a formal investigation to scrutinize conflict of interest allegations against Jeff Shuren, M.D., J.D. the former director of the Food and Drug Administration (FDA)’s Center for Devices and Radiological Health.
[Created on 9/20/2024]

Testimony Before the FDA’s Antimicrobial Drugs Advisory Committee Meeting about Sulopenem Etzadroxil/Probenecid for Uncomplicated Urinary Tract Infection (HRG Publication #2695)
In testimony before the FDA’s Antimicrobial Drugs Advisory Committee about oral sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infection in adult women, Public Citizen emphasized our concerns about the significant risk of increasing antimicrobial resistance if the drug was widely used for uncomplicated urinary tract infection, the insufficient evidence that the drug was either a superior drug or needed alternative to existing first line treatments, and the importance of further study of the potential for increased antimicrobial resistance at both the individual and population level.
[Created on 9/9/2024]

Stakeholder comment to Reagan-Udall/FDA meeting regarding the treatment for PTSD (HRG Publication #2694)
Public Citizen made formal comment at the Reagan-Udall Foundation for the Food and Drug Administration’s meeting on Advancing Treatments for Post-Traumatic Stress Disorder (PTSD). Those comments focused on the FDA’s recent rejection of the psychedelic drug midomafetamine (MDMA, “ecstasy,” “molly”) to enable the treatment of PTSD. The drug was previously rejected by the FDA to treat PTSD in combination with intensive (8-hour) psychotherapy. Public Citizen opposes further consideration of such psychedelic drugs until the relevant drug trials better address unblinding-bias, concerns about addiction, other potential adverse physiologic effects, and concerns that the psychotherapy aspects of the treatment are unstandardized and potentially unsafe.
[Created on 9/6/2024]

Press Release: Office of Inspector General at Department of Health and Human Services Should Investigate Conflict of Interest Allegations Against Senior FDA Official (HRG Publication #2693)
A disturbing article in the New York Times on Tuesday reveals that while a senior Food and Drug Administration (FDA) official, Jeff Shuren, M.D., J.D., was in charge of regulating medical devices, his wife’s powerful Washington law firm was representing their manufacturers.
[Created on 8/20/2024]

Press Release: FDA was Right to Decline Approval of MDMA-Assisted Therapy for PTSD and Encourage Further Research (HRG Publication #2692)
The Food and Drug Administration (FDA) on Friday declined to approve midomafetamine (MDMA)-assisted therapy as a treatment for posttraumatic stress disorder (PTSD). Treatment with the psychedelic was to be administered along with psychotherapy. In testimony in June 2024 before a FDA advisory committee, Public Citizen urged the agency not to approve MDMA because of concerns about its safety and effectiveness and the conduct of the main clinical trial. After a full discussion of the available evidence, the advisory committee voted overwhelmingly against the use of MDMA for treating PTSD.
[Created on 8/9/2024]

Comment to CMS Requesting a MEDCAC meeting for the EVOQUE Tricuspid Valve Replacement System (HRG Publication #2691)
In a written comment to the Centers for Medicare & Medicaid Services, Dr. Robert Steinbrook, Health Research Director at Public Citizen, urged that CMS convene a meeting of MEDCAC as part of the National Coverage Analysis for the EVOQUE Tricuspid Valve Replacement System.
[Created on 7/18/2024]

Press Release: FDA Fails Patients By Approving Flawed Alzheimer’s Disease Drug Donanemab (Kisunla) (HRG Publication #2690)
The Food and Drug Administration (FDA) on Tuesday approved donanemab-azbt (Kisunla) for the treatment of Alzheimer’s disease. The drug is an amyloid beta-directed antibody that is administered as an intravenous infusion every four weeks. In recent testimony before an FDA advisory committee and in a press statement, Public Citizen urged the agency not to approve donanemab.
[Created on 7/2/2024]

Comments on New Jersey’s Proposed Rule on Sexual Misconduct Education and Prevention (HRG Publication #2689)
Public Citizen submitted comments supporting a proposed New Jersey rule for physician education about sexual misconduct prevention and patient right to an observer. We also called for improving the rule by (1) ensuring adequacy of educational programs, (2) extending patient right to a trained observer to all clinical encounters and mandating use of trained observers during sensitive examinations in all health care settings, (3) promoting independence of observers, (4) replacing use of board-mandated observers for abusive physicians with more effective measures to protect patients, and (5) educating patients about proper sensitive examination.
[Created on 6/14/2024]

Comments at the FDA’s Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees (HRG Publication #2688)
In comments at the Food and Drug Administration’s (FDA’s) public meeting, “Optimizing FDA’s Use of and Processes for Advisory Committees,” Public Citizen urged the FDA to (1) maintain or perhaps even expand voting questions as a central feature of advisory committee meetings; (2) release publicly available briefing materials five to seven business days before the date of the advisory committee meeting, not, as is typically the case now, no later than two full business days before the meeting; and (3) reduce to zero, with rare exceptions, the number of voting members of advisory committees who are granted waivers to participate despite having an otherwise disqualifying financial interest.
[Created on 6/13/2024]

Press Release: FDA Should Not Approve Flawed Alzheimer’s Disease Drug Donanemab (HRG Publication #2687)
A Food and Drug Administration (FDA) advisory committee on Monday discussed an application for approval of donanemab for the treatment of Alzheimer’s disease. The subjects in the clinical trials had mild cognitive impairment and mild dementia.
[Created on 6/10/2024]

Viewpoint in JAMA Internal Medicine: Less Care at Higher Cost-The Medicare Advantage Paradox (HRG Publication #2686)
According to a new analysis, published June 10, 2024 in JAMA Internal Medicine, privatized Medicare Advantage plans have raised Medicare’s costs by $612 billion since 2007, including $82 billion in 2023 alone. The authors are physicians affiliated with Harvard Medical School, the City University of New York’s Hunter College, and Public Citizen’s Health Research Group.
[Created on 6/10/2024]

Testimony Before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee Regarding Donanemab for the Treatment of Alzheimer’s Disease (HRG Publication #2685)
In testimony before the Food and Drug Administration’s (FDA’s) Peripheral and Central Nervous System Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve donanemab for the treatment of Alzheimer’s Disease because the evidence for the drug’s benefits does not outweigh its significant risks.
[Created on 6/10/2024]

Comment regarding the FDA’s draft guidance on developing treatments for early Alzheimer’s disease (HRG Publication #2684)
In this comment to the Federal Register, Public Citizen expresses concern about the FDA’s draft guidance for developing drugs for early Alzheimer’s disease because the proposed definition of early Alzheimer’s disease and the reliance on biomarkers as both a diagnostic tool and a measure of benefit. Moreover, the proposed criteria for the duration of clinical trials and the selection of clinical endpoints are concerning.
[Created on 6/7/2024]

Testimony to the FDA opposing midomafetamine (MDMA, “ecstasy”) as a treatment for PTSD (HRG Publication #2683)
Public Citizen testified at a meeting of the FDA’s Psychopharmacologic Drug Advisory Committee regarding the psychedelic drug midomafetamine (MDMA, “ecstasy,” “molly”) as a potential treatment for posttraumatic stress disorder (PTSD). The drug is being considered for that indication in combination with intensive (8-hour) psychotherapy. In that testimony Public Citizen opposed approval of midomafetamine for PTSD because of concerns regarding both safety and effectiveness.
[Created on 6/4/2024]

Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding insulin icodec (HRG Publication #2682)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Endocrinologic and Metabolic Drugs Advisory Committee, Public Citizen urged the committee to vote “No” on the question regarding whether Novo Nordisk demonstrated that the benefits of the new once-weekly drug insulin icodec outweigh its risks for improving glycemic control in adults with type 1 diabetes. We discussed how diabetic patients would not be served by premature approval of this inadequately tested new ultra-long-acting insulin.
[Created on 5/24/2024]

Report: Thirty-one years of pharmaceutical industry criminal and civil penalties: 1991-2021 (HRG Publication #2681)
The report summarizes 31-years (1991-2021) of successful legal settlements or judgments won by U.S. federal or state governments against pharmaceutical manufacturers. The report is the fifth such study by Public Citizen’s Health Research Group since 2010. The 65-page document details (with graphs, tables and text) the number and monetary size of essentially all cases that U.S. governments settled against pharmaceutical makers and stratifies those cases into analytic categories including: state vs. federal, criminal vs. civil and various violation types (e.g., overcharging government programs, unlawful promotion). In total over $62 billion in financial penalties assessed against the pharmaceutical industry are described. In recent years opioid-related settlements have been especially prominent.
[Created on 5/21/2024]

Letter to the CDC and FDA Regarding Recent Health Advisory on Clusters of Patients with Adverse Events From Certain Botulinum Toxin Injections (HRG Publication #2680)
In a letter to the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), Public Citizen asked that a recent health advisory regarding what the advisory characterized as “counterfeit or mishandled” injections of botulinum toxin be revised to ensure that clinicians err on the side of suspecting iatrogenic botulism in all patients experiencing adverse effects consistent with the distant spread of the botulinum toxin. The letter also asked the agencies to consider the possibility of iatrogenic botulism from recommended doses of approved and properly administered botulinum toxin drugs.
[Created on 4/30/2024]

CDC Should Promptly Facilitate Administration of Botulinum Antitoxin to People with Illnesses Linked to Counterfeit “Botox” (HRG Publication #2679)
In response to a CDC announcement about investigating illnesses caused by counterfeit Botox, HRG is asking the agency to follow its guidelines that recommend the administration of botulinum antitoxin as quickly as possible to all patients with signs or symptoms that are suggestive of iatrogenic botulism. We also asked the agency to consider the possibility that at least some of the cases may be related to iatrogenic botulism due to FDA-approved Botox and related drugs, including the doses in the prescribing information, per our December 2023 petition to the FDA regarding these drugs.
[Created on 4/17/2024]

Manufacturer Withdraws Amyotrophic Lateral Sclerosis Drug AMX0035 (Relyvrio) From Market (HRG Publication #2678)
Amylyx Pharmaceuticals said on Thursday that it would withdraw AMX0035 (sodium phenylbutyrate and taurursodiol, sold as Relyvrio) from the market. A large clinical trial recently found that the drug did not provide any benefit to patients with amyotrophic lateral sclerosis (ALS). In 2022, Public Citizen urged the Food and Drug Administration (FDA) not to approve AMX0035 because the data from a single small clinical trial and its open-label extension study were inconclusive.
[Created on 4/4/2024]

Use of Impella Left Ventricular Assist Devices Should Be Stopped (HRG Publication #2677)
Abiomed has recalled the instructions for use for Impella left ventricular assist devices due to the risks of the device perforating the wall of the heart. The Food and Drug Administration (FDA) has issued a MedWatch notice, identifying the recall as Class 1, the most serious type.
[Created on 3/29/2024]

Amyotrophic Lateral Sclerosis Drug AMX0035 (Relyvrio) Should Be Promptly Removed from the Market (HRG Publication #2676)
Amylyx Pharmaceuticals said on Friday that AMX0035 (sodium phenylbutyrate and taurursodiol, marketed as Relyvrio) did not provide any benefit to patients with amyotrophic lateral sclerosis (ALS) in a clinical trial of 664 subjects, and that it may voluntarily withdraw the drug from the market. In 2022, Public Citizen urged the Food and Drug Administration (FDA) not to grant AMX0035 approval because the data from a single phase 2 clinical trial of 137 subjects and its open-label extension study were inconclusive.
[Created on 3/8/2024]

FDA Should Protect Patients by Prioritizing Prompt Revisions of Safety Labeling for Drugs (HRG Publication #2675)
Earlier this month, the Food and Drug Administration (FDA) finally responded to a July 2011 petition from Public Citizen’s Health Research Group requesting added safety warnings on the labels of glucocorticosteroids including prednisone. Dr. Robert Steinbrook, director of Public Citizen’s Health Research Group, released the following statement in response: “It is outrageous that the FDA, a public health agency, took 12-and-a-half years to respond to a citizen petition to improve safety labeling for widely used medications.”
[Created on 2/20/2024]

Testimony to the FDA about improving the performance of pulse oximeters (blood oxygen monitors) taking into account race, ethnicity, and differences in skin pigmentation (HRG Publication #2674)
In this testimony to the Food and Drug Administration’s (FDA) Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee, Public Citizen calls for substantial increases in the racial, ethnic, and skin pigmentation diversity of clinical trials that are required to support the market-clearance of pulse oximeters (non-invasive, blood oxygen monitors), and for the FDA to recall or remove oximeters that fail to demonstrate they are effective in persons with non-White skin. Public Citizen also encourages the FDA to rapidly implement labeling changes on existing pulse oximeters, to educate clinicians about the potential inaccuracies of these devices when they are used on persons with darker skin.
[Created on 2/2/2024]

Alzheimer’s Drug Lecanemab (Leqembi) of Greater Concern than Little-Used Aducanumab (HRG Publication #2673)
Biogen said on Wednesday that it would give up ownership of the controversial Alzheimer’s drug aducanumab (Aduhelm) and withdraw it from the U.S. market. In 2021, Public Citizen expressed outrage about the “indefensible decision” of the Food and Drug Administration (FDA) to grant aducanumab accelerated approval, characterizing the action as “one of the most irresponsible and egregious decisions in the history of the agency.”
[Created on 2/1/2024]

2023

Comment regarding the FDA’s proposed funding of the RADARS drug abuse surveillance system (HRG Publication #2672)
In this comment to the Federal Register, Public Citizen expresses concern about a proposal to support the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) program because of that program’s historical and contemporary ties to the pharmaceutical industry.
[Created on 12/18/2023]

Petition to the FDA to Strengthen Safety Warning for Botox and Related Drugs and Remove Misleading Claims From Botox/Botox Cosmetic Labeling (HRG Publication #2671)
Public Citizen petitioned the Food and Drug Administration (FDA) to promptly emphasize the risk of iatrogenic botulism in the labeling of approved botulinum-toxin drugs (such as Botox and related drugs) and remove misleading promotional claims from Botox and Botox Cosmetic labeling.
[Created on 12/12/2023]

Comments on the FDA’s Proposed Rule Regarding Medication Guides: Patient Medication Information (HRG Publication #2670)
Public Citizen submitted comments to the Food and Drug Administration supporting the agency’s proposed rule requiring a new type of written one-page document — called Patient Medication Information (PMI) — that would be handed to patients each time they acquire a prescription drug product or biological product for use in an outpatient setting. To improve this rule, we urged the agency to implement a few changes, including using plain-language and consumer testing in PMI development, translating PMI to common non-English spoken languages, and expanding waivers for exceeding the one-page limit.
[Created on 11/27/2023]

Testimony Before the FDA’s Pulmonary-Allergy Drugs Advisory Committee Meeting Regarding Gefapixant for the Treatment of Chronic Cough (HRG Publication #2669)
In testimony before the Food and Drug Administration’s (FDA’s) Pulmonary-Allergy Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve gefapixant for the treatment of chronic cough because the small effects of treatment with the drug do not provide substantial evidence of a clinically meaningful benefit for patients.
[Created on 11/17/2023]

Testimony before the Food and Drug Administration’s Cellular, Tissue, and Gene Therapy Advisory Committee regarding Exagamglogene Autotemcel Gene Therapy for Sickle Cell Disease (BLA# 125787/0, Vertex Pharmaceuticals) (HRG Publication #2668)
In this testimony, Public Citizen argues against approval of exagamglogene autotemcel gene therapy for sickle cell disease (BLA# 125787/0, Vertex Pharmaceuticals) because of unresolved concerns about safety.
[Created on 10/31/2023]

Testimony before the Food and Drug Administration’s Cellular, Tissue, and Gene Therapy Advisory Committee Regarding Debamestrocel (MSC-NTF, NurOwn; Brainstorm Cell Therapeutics) as a Potential Treatment for Amyotrophic Lateral Sclerosis (BLA 125782) (HRG Publication #2667)
In this testimony, Public Citizen argues against approval of debamestrocel (autologously transplanted mesenchymal stromal cells engineered to secrete increased levels of neurotrophic factors, MSC-NTF) as treatment for amyotrophic lateral sclerosis (ALS) because the biologic drug has yet to demonstrated safety and effectiveness for that indication.
[Created on 9/27/2023]

Testimony before the Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee Meeting Regarding the ITCA 650 Drug-Device for Type 2 Diabetes (HRG Publication #2666)
In this oral, public testimony, Public Citizen argues against approval of the ITCA 650 drug-device combination (NDA #209053) as an adjunct treatment for glycemic control in persons with type 2 diabetes because the device has yet to demonstrate that it is reasonably safe and effective.
[Created on 9/21/2023]

Press Statement: FDA Must Prioritize Removal of Oral Phenylephrine From Shelves (HRG Publication #2665)
As a follow-up on Public Citizen’s testimony urging the Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee to vote against the efficacy of oral phenylephrine for nasal congestion, we are asking the agency to prioritize prompt removal of this drug from the U.S. market.
[Created on 9/15/2023]

Testimony Before the FDA’s Nonprescription Drugs Advisory Committee Regarding the Efficacy of Oral Phenylephrine as a Nasal Congestant (HRG Publication #2664)
In a PC testimony before the Food and Drug Administration’s (FDA’s) Nonprescription Drugs Advisory Committee (NDAC), Public Citizen urged the committee to vote “No” on the questions regarding whether the current evidence supports the effectiveness of orally administered oral phenylephrine for nasal congestion and whether a higher oral dosage of the drug would be safe and effective. This is because the current evidence — from updated FDA analysis of original prior studies that had used outdated technology/research design as well as evidence from three new well-designed clinical trials — clearly shows that orally administered phenylephrine is not effective at any dose that can be administered with a reasonable margin of safety.
[Created on 9/11/2023]

Report: Ranking of the Rate of State Medical Boards’ Serious Disciplinary Actions, 2019-2021 (HRG Publication #2663)
This report examines the performance of state medical boards in protecting the public from dangerous physicians by disciplining doctor misconduct. Using state-level data on serious disciplinary actions from the National Practitioner Data Bank’s Public Use Data File, the report compares the performance of the state medical boards based on the annual average number of serious disciplinary actions taken by the boards per 1,000 licensees during the 2019-2021 period..
[Created on 8/16/2023]

Q&A with Dr. Robert Steinbrook, the new Director of Public Citizen’s Health Research Group (HRG Publication #2662)
Public Citizen has announced that Dr. Robert Steinbrook is the new Director of its Health Research Group. In a question-and-answer format, Dr. Steinbrook discusses his background and the Health Research Group’s priorities.
[Created on 7/31/2023]

Press Statement: FDA Approval of Lecanemab (Leqembi) for Alzheimer’s Disease Fails Patients and the Public (HRG Publication #2661)
The U.S. Food and Drug Administration (FDA) today gave full approval to the drug lecanemab (Leqembi) to treat adults with Alzheimer’s disease. In January Public Citizen urged the agency not to approve the drug, and in June Public Citizen urged the agency not to grant full approval.
[Created on 7/6/2023]

Letter to the FDA opposing accelerated approval of the gene therapy SRP-9001 as a treatment for ambulatory Duchenne muscular dystrophy (DMD) (HRG Publication #2660)
In a letter to leaders at the Food and Drug Administration (FDA), Public Citizen urged that the accelerated approval application for the biologic drug SRP-9001 (a gene therapy) for Duchenne muscular dystrophy (DMD) be rejected because of concerns about effectiveness, safety and regulatory history.
[Created on 6/15/2023]

Testimony Before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee Regarding Lecanemab for the Treatment of Alzheimer’s Disease (HRG Publication #2659)
In testimony before the Food and Drug Administration’s (FDA’s) Peripheral and Central Nervous System Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve the supplemental biologics license application for lecanemab for the treatment of Alzheimer’s disease, because the evidence for the drug’s benefits does not outweigh its significant risks.
[Created on 6/9/2023]

Testimony before the FDA’s Gastrointestinal Drugs Advisory Committee regarding the possible accelerated approval of obeticholic acid (NDA# 212833) to treat nonalcoholic steatohepatitis with fibrosis (HRG Publication #2658)
In testimony before the Food and Drug Administration’s (FDA’s) Gastrointestinal Drugs Advisory Committee, Public Citizen urged the committee to reject accelerated approval for obeticholic acid (a synthetic bile acid) as a treatment for fatty liver disease because of inadequate efficacy on two surrogate endpoints and because of many safety concerns that included drug induced liver disease.
[Created on 5/19/2023]

Testimony before the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee Regarding SRP-9001 (delandistrogene moxeparvovec) for the Treatment of Duchenne Muscular Dystrophy (HRG Publication #2657)
In testimony before the Food and Drug Administration’s (FDA’s) Cellular, Tissue and Gene Therapies Advisory Committee, Public Citizen urged the committee to reject accelerated approval for SRP-9001 (a gene therapy) for Duchenne muscular dystrophy because the sponsor-presented data did not support the drug’s effectiveness and because of concerning regulatory history for related drugs.
[Created on 5/12/2023]

Letter to the FDA Opposing Approval of Brexpiprazole for the Treatment of Agitation Associated with Alzheimer’s Dementia (HRG Publication #2656)
In a letter to the Food and Drug Administration (FDA), Public Citizen urged FDA to reject brexpiprazole for the treatment of agitation associated with Alzheimer’s dementia because the drug’s small benefits do not outweigh its significant risks and because no population for which the benefits would outweigh the risks was identified.
[Created on 5/3/2023]

Petition to the FDA to Amend the List of Drug Products That Were Withdrawn or Removed From the Market Because They Were Deemed Unsafe of Ineffective to Include Hydroxyprogesterone Caproate for Prevention of Preterm Birth (HRG Publication #2655)
Public Citizen petitioned the Food and Drug Administration (FDA) to promptly initiate the regulatory process to amend the list of drug products that were withdrawn or removed from the market for reasons of safety or effectiveness and that therefore may not be compounded to include hydroxyprogesterone caproate injection for prevention of preterm birth.
[Created on 4/27/2023]

Testimony Before the FDA’s Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee Regarding Brexpiprazole (HRG Publication #2654)
In testimony before the Food and Drug Administration’s (FDA’s) Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve brexpiprazole for the treatment of agitation in patients with Alzheimer’s disease because the drug’s small benefits do not outweigh its significant risks.
[Created on 4/14/2023]

Updated PowerPoint Presentations on Health Policy Issues Relevant to Health Care Reform and a National Single-Payer Health System (HRG Publication #2653)
Drs. Steffie Woolhandler and David Himmelstein, Faculty at the City University of New York at Hunter College and Harvard Medical School and Research Associates at Public Citizen’s Health Research Group, have prepared an updated large library of slides with data on a range of health policy issues relevant to health care reform and a more compact slide set related to a national single-payer health system.
[Created on 4/6/2023]

Ineffective Medication for Prevention of Preterm Birth Should Have Been Withdrawn Years Ago (HRG Publication #2652)
Makena (hydroxyprogesterone caproate) should have been removed from the market soon after the results of the postmarket PROLONG trial demonstrating that the drug provided no clinical benefits were released in early 2019.
[Created on 3/8/2023]

Comments to the CPSC Regarding the Agency’s Notice of Proposed Rulemaking for a Safety Standard for Adult Portable Bed Rails (HRG Publication #2651)
In comments to the Consumer Product Safety Commission (CPSC), Public Citizen urged the agency to withdraw its proposed rule to require that all adult portable bed rails meet the requirements of the applicable voluntary standard on adult portable bed rails, with modifications, and to instead promulgate a rule under section 8 of the Consumer Product Safety Act declaring all currently marketed adult bed rails to be banned hazardous products.
[Created on 1/9/2023]

Letter to the FDA Urging Postponement of the Approval Decision Regarding Lecanemab for Treatment of Alzheimer’s Disease (HRG Publication #2650)
In a letter to the Food and Drug Administration (FDA), Public Citizen urged the FDA to postpone the approval decision regarding lecanemab for treatment of Alzheimer’s disease until the agency convenes an advisory committee to consider the new drug application for the drug.
[Created on 1/4/2023]

2022

Letter to the FDA Opposing Approval of Daprodustat and Other Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors (HRG Publication #2649)
In a letter to the Food and Drug Administration (FDA), Public Citizen urged FDA not to approve daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PHD) inhibitor, or any other HIF-PHD inhibitors for the treatment of anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis, because drugs of this class do not offer patients any additional benefits but have significant additional risks.
[Created on 12/14/2022]

Testimony Before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding Omecamtiv Mecarbil For the Treatment of Heart Failure (HRG Publication #2648)
In testimony before the Food and Drug Administration’s (FDA’s) Cardiovascular and Renal Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve omecamtiv mecarbil to reduce the risk of cardiovascular death and heart failure events in adults with symptomatic chronic heart failure with reduced ejection fraction because the drug’s minimal benefits do not outweigh its significant risks.
[Created on 12/13/2022]

Letter to the FDA Opposing Marketing Authorization of AvertD for Identifying Patients at Increased Genetic Risk of Opioid Use Disorder (HRG Publication #2647)
In a letter to the Food and Drug Administration (FDA), Public Citizen urged the FDA to deny marketing authorization for AvertD — and any future marketing applications for similar genetic tests for assessing opioid use disorder (OUD) risk — because the device has no clinical utility for predicting the risk of developing OUD, and it relies on the false and dangerous assumption that there is a subset of patients at high risk of developing OUD who can be readily identified.
[Created on 12/7/2022]

Comments on the FDA’s Proposed Rule Regarding Nonprescription Drug Products With an Additional Condition for Nonprescription Use (HRG Publication #2646)
Public Citizen submitted comments to the Food and Drug Administration (FDA) opposing the agency’s proposed rule that would establish requirements for nonprescription drug products that have an additional condition for nonprescription use that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner.
[Created on 11/25/2022]

Follow-up Comments to the FDA Regarding CDER’s Proposal to Withdraw Approval of Makena (Hydroxyprogesterone Caproate) (HRG Publication #2645)
In follow-up comments to the Food and Drug Administration regarding the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of Makena (hydroxyprogesterone caproate) for prevention of preterm labor, Public Citizen urged the agency to take prompt regulatory action as soon as the approval of Makena is withdrawn to prevent the predictable pharmacy compounding of hydroxyprogesterone caproate for prevention of preterm birth.
[Created on 11/2/2022]

Testimony Before the FDA’s Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Regarding Pulse Oximeters (HRG Publication #2644)
In testimony before the Food and Drug Administration’s (FDA’s) Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee, which was convened to consider factors that impact the accuracy of pulse oximeters — especially skin pigmentation — Public Citizen argued for better device premarket standards to address long-standing concerns that pulse oximeters are too often not sufficiently effective as clinical tools for persons of color because skin pigmentation interferes with blood oxygen saturation readings of these devices.
[Created on 11/1/2022]

Testimony Before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding Daprodustat for the Treatment of Anemia Due to Chronic Kidney Disease (HRG Publication #2643)
In testimony before the Food and Drug Administration’s (FDA’s) Cardiovascular and Renal Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve daprodustat for treatment of anemia due to chronic kidney disease in adult patients not on dialysis or on dialysis because the drug offers no unique benefits compared to earlier FDA-approved erythropoiesis-stimulating agents but does have greater risks of serious adverse events.
[Created on 10/26/2022]

Testimony Before the FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel Opposing Marketing Authorization of the AvertD Genetic Test to Predict the Risk of Opioid Use Disorder (HRG Publication #2642)
In testimony before the Food and Drug Administration’s (FDA’s) Clinical Chemistry and Clinical Toxicology Devices Panel, which was convened to consider the AvertD genetic test for predicting opioid use disorder risk in patients prior to their first prescription of an opioid, Public Citizen argued against marketing authorization because there was insufficient evidence of the device’s effectiveness and other research indicated such genetic-based predictions are scientifically implausible.
[Created on 10/20/2022]

Press Statement: FDA Commissioner, Chief Scientist Must Move Swiftly to Remove Medication for Prevention of Preterm Birth from Market (HRG Publication #2641)
Public Citizen applauds the near-unanimous recommendation of the FDA’s Obstetrics, Reproductive, and Urologic Drugs Advisory Committee to remove Makena from the market. This science-based recommendation was the only logical outcome.
[Created on 10/19/2022]

Testimony Before the FDA’s Hearing on CDER’s Proposal to Withdraw Approval of Makena (Hydroxyprogesterone Caproate) (HRG Publication #2640)
In testimony before the Food and Drug Administration’s (FDA’s) hearing on the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of Makena (hydroxyprogesterone caproate), Public Citizen argued that the agency must remove Makena from the market because it is not effective for preventing preterm birth or related fetal and neonatal health problems and death.
[Created on 10/18/2022]

Letter to the FDA Opposing Approval of the Drug AMX0035 for Treatment of Amyotrophic Lateral Sclerosis (HRG Publication #2639)
In a letter to the Food and Drug Administration regarding whether the combination drug AMX0035 (sodium phenylbutyrate and taurursodiol) should be approved for treating amyotrophic lateral sclerosis, Public Citizen argued against approval because the data from a clinical trial of the drug failed to provide substantial evidence of effectiveness.
[Created on 9/23/2022]

Invited Commentary Published in JAMA Internal Medicine: Curbing the Financial Incentives That Contribute to the High Prices of Prescription Drugs in the US (HRG Publication #2638)
In an invited commentary published in JAMA Internal Medicine, Public Citizen’s Dr. Sidney Wolfe explains why Congress needs to enact further legislation to curb the perverse systemic financial incentives that contribute to the high prices of prescription drugs in the U.S.
[Created on 9/12/2022]

Testimony Before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee Regarding the Drug AMX0035 for Treatment of Amyotrophic Lateral Sclerosis (HRG Publication #2637)
In testimony before the Food and Drug Administration’s (FDA’s) Peripheral and Central Nervous System Drugs Advisory Committee, which was convened to reconsider whether the combination drug AMX0035 (sodium phenylbutyrate and taurursodiol) should be approved for treating amyotrophic lateral sclerosis, Public Citizen argued against approval because additional analyses of data from a clinical trial of the drug again failed to provide substantial evidence of effectiveness.
[Created on 9/7/2022]

Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee Regarding Pimavanserin for the Treatment of Hallucinations and Delusions in Alzheimer’s Disease Psychosis (HRG Publication #2636)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Psychopharmacologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve pimavanserin for the treatment of hallucinations and delusions in Alzheimer’s disease psychosis because clinical trials of the drug failed to demonstrate that it is effective.
[Created on 6/17/2022]

Testimony Before the FDA’s Pharmacy Compounding Advisory Committee Regarding Adding Lorcaserin Hydrochloride to the List of Drug Products Withdrawn or Removed from the Market (HRG Publication #2635)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Pharmacy Compounding Advisory Committee, Public Citizen urged that all drug products containing lorcaserin hydrochloride be added to the list of drugs that have been withdrawn or removed from the market because they were deemed unsafe or not effective and that therefore may not be compounded under the exemptions provided by Section 503A(a) or Section 503B(a) of the Food, Drug, and Cosmetic Act.
[Created on 6/8/2022]

Letter to Congress Calling for the Retention of a House-Passed Provision in H.R. 4521, the America COMPETES Act, That Would Give the FDA Mandatory Recall Authority For All Drugs (HRG Publication #2634)
In a letter submitted to members of the U.S. Congress conference committee for H.R. 4521, the America COMPETES Act/United States Innovation and Competition Act, Public Citizen urged Senate and House conferees to retain a House-passed provision that would give the Food and Drug Administration (FDA) mandatory recall authority for all drugs.
[Created on 5/20/2022]

First Opinion Commentary in STAT: NEJM, Other Journals: Provide More Transparency About Conflicts of Interest or Don’t Publish Conflicted Articles (HRG Publication #2633)
In a First Opinion commentary published in STAT, Dr. Martin Shapiro, a professor of medicine at Weill Cornell Medical College, and Dr. Sidney Wolfe, founder and senior advisor to Public Citizen’s Health Research Group, criticized the New England Journal of Medicine (NEJM) for publishing a commentary strongly endorsing the pharmaceutical industry’s perspective on drug pricing that was authored by economists with drug company ties that were not adequately disclosed within the piece itself.
[Created on 5/19/2022]

Press Statement: FDA Refuses to Impose Serious Sanctions Against Researchers at Minnesota Hospital Who Conducted Unethical High-Risk Experiments (HRG Publication #2632)
The Food and Drug Administration’s (FDA’s) failure to seriously sanction Hennepin County Medical Center researchers sends a clear signal to the research community and public that the agency is not serious about protecting the rights and welfare of human subjects.
[Created on 5/2/2022]

Article Published in Health Matrix: The Journal of Law-Medicine: Public Citizen’s Advocacy Campaign Opposing FDA Approval of Aducanumab for Alzheimer’s Disease: The Fight Against Regulatory Capture (HRG Publication #2631)
In an edited version of the annual Oliver C. Schroeder, Jr. Scholar-in-Residence Lecture sponsored by the Law-Medicine Center on October 4, 2021, at Case Western Reserve University School of Law, Dr. Michael Carome described Public Citizen’s advocacy campaign opposing Food and Drug Administration (FDA) approval of aducanumab for treating Alzheimer’s disease and seeking to hold the agency accountable for its inappropriately close collaboration with Biogen and for its reckless decision to approve the drug.
[Created on 4/28/2022]

Letter to Congress Regarding Legislation to Reauthorize PDUFA and MDUFA (HRG Publication #2630)
In a letter to the U.S. Senate’s Health, Education, Labor and Pensions Committee, Public Citizen urged the Committee to consider including multiple provisions in legislation to reauthorize the Prescription Drug User Fee Act and Medical Device User Fee Amendments for fiscal years 2023 to 2027 (PDUFA VII and MDUFA V, respectively) that would strengthen the Food and Drug Administration’s independence from regulated industries and significantly enhance the agency’s regulatory oversight of prescription drugs and medical devices.
[Created on 4/25/2022]

Comments Submitted to OSHA Regarding a Standard for Occupational Exposure to COVID-19 in Healthcare Settings (HRG Publication #2629)
Public Citizen expressed strong support for the Occupational Safety and Health Administration’s (OSHA’s) plan to issue a final standard to protect healthcare and healthcare support service workers from occupational exposure to COVID-19 and offered detailed comments regarding potential changes in the final standard.
[Created on 4/22/2022]

Comments Submitted to the FDA Regarding Reauthorization of the Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 (MDUFA V) (HRG Publication #2628)
In a comments submitted to the Food and Drug Administration (FDA), Public Citizen urged the agency to revise its draft commitment letter regarding the Medical Device User Fee Amendments for fiscal years 2023 to 2027 (MDUFA V) to strengthen its independence from regulated industry and its regulatory oversight of medical devices.
[Created on 4/21/2022]

Testimony at the FDA’s Public Meeting Regarding Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 (HRG Publication #2627)
In testimony at a public meeting convened by the Food and Drug Administration (FDA), Public Citizen urged the agency to revise its draft commitment letter regarding the Medical Device User Fee Amendments for fiscal years 2023 to 2027 (MDUFA V) to strengthen its independence from regulated industry and its regulatory oversight of medical devices.
[Created on 4/19/2022]

Press Statement: CMS Resists Big Pharma Pressure Campaign, Makes the Right Call in Restricting Medicare Coverage for the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2626)
Public Citizen applauds CMS for standing its ground in the face of intense pressure orchestrated by Big Pharma and industry-funded ‘patient’ advocacy groups. The final decision restricts Medicare coverage for aducanumab to beneficiaries with Alzheimer’s disease who enroll in randomized, controlled clinical trials of the drug.
[Created on 4/7/2022]

Testimony Before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee Regarding the Drug AMX0035 for Treatment of Amyotrophic Lateral Sclerosis (HRG Publication #2625)
In testimony before the Food and Drug Administration’s (FDA’s) Peripheral and Central Nervous System Drugs Advisory Committee, Public Citizen argued against approval of the combination drug AMX0035 (sodium phenylbutyrate and taurursodiol) for treating amyotrophic lateral sclerosis because clinical trial data failed to provide substantial evidence of effectiveness.
[Created on 3/30/2022]

Letter to Congress Regarding Legislation to Reauthorize the Medical Device User Fee Amendments (HRG Publication #2624)
In a letter to the Committee on Energy & Commerce’s Subcommittee on Health in the U.S. House of Representatives, Public Citizen urged the subcommittee to consider including multiple provisions in legislation to reauthorize the Medical Device User Fee Amendments for fiscal years 2023 to 2027 (MDUFA V) that would significantly enhance the Food and Drug Administration’s regulatory oversight of medical devices, particularly high-risk, permanently implanted devices.
[Created on 3/29/2022]

Press Statement: CPSC Action Insufficient to Stem the Tide of Fatalities Caused by Adult Portable Bed Rails (HRG Publication #2623)
As long as adult portable bed rails remain on the market, frail vulnerable adults will continue to die unnecessarily from strangulation when their head or neck becomes entrapped in the bed rail. These products are inherently unsafe, and no feasible safety standards will eliminate the risk of death.
[Created on 3/16/2022]

Letter to Congress Regarding Legislation That Would Change the FDA’s Accelerated-Approval Program for New Drugs (HRG Publication #2622)
In a letter to the Committee on Energy & Commerce’s Subcommittee on Health in the U.S. House of Representatives, Public Citizen urged the subcommittee to oppose H.R. 6996, the Accelerating Access for Patients Act of 2022, and instead support H.R. 6963, the Accelerated Approval Integrity Act of 2022.
[Created on 3/16/2022]

Letter to Congress Calling for Amendments to S. 3799, the PREVENT Pandemics Act (HRG Publication #2621)
In a letter to the U.S. Senate Committee on Health, Education, Labor and Pensions, Public Citizen urged that certain sections of S. 3799, the PREVENT Pandemics Act — including two sections related to Food and Drug Administration oversight of drugs and medical devices — be excluded or amended before the legislation is finalized.
[Created on 3/14/2022]

Letter to Congress Calling for Amendments to H.R. 6000, the Cures 2.0 Act (HRG Publication #2620)
In a letter to U.S. House of Representatives Speaker Nancy Pelosi and Minority Leader Kevin McCarthy, Public Citizen expressed opposition to H.R. 6000, the Cures 2.0 Act, unless the legislation is amended to exclude or substantially revise key provisions related to Food and Drug Administration oversight of drugs and Medicare coverage for medical devices.
[Created on 2/24/2022]

Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding Intravenous Tramadol (HRG Publication #2619)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen urged the committees to recommend that the FDA not approve an intravenous form of tramadol, a widely used but inadequately regulated opioid, for treatment of acute pain in a medically supervised health care setting.
[Created on 2/15/2022]

Comments Submitted to CMS Regarding the Proposed National Coverage Determination for Aducanumab for Treatment of Alzheimer’s Disease (HRG Publication #2618)
Public Citizen strongly supports the Centers for Medicare and Medicaid Services’ (CMS’) proposed national coverage determination for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (CAG-00460N), under which the Medicare program would cover the drug aducanumab only for beneficiaries who enroll in CMS-approved randomized, controlled clinical trials meeting certain criteria or in trials supported by the National Institutes of Health.
[Created on 2/10/2022]

Petition to the DEA and FDA to Classify the Drug Gabapentin as a Schedule V Controlled Substance (HRG Publication #2617)
Public Citizen petitioned the Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) to add the prescription drugs gabapentin and gabapentin enacarbil to schedule V under the Controlled Substances Act to more tightly monitor and regulate use of these drugs because they are increasingly being misused, abused, and diverted, leading to dependence and overdose deaths.
[Created on 2/9/2022]

Letter to the Maryland Senate’s Education, Health, and Environmental Affairs Committee Opposing a Bill That Would Impede Investigations by the Maryland Board of Physicians (HRG Publication #2616)
Public Citizen urged the Maryland Senate’s Education, Health, and Environmental Affairs Committee to place the health interests of Maryland patients above the protection of incompetent and unprofessional physicians by giving SB 77 an unfavorable report because the legislation would seriously impede the ability of the Maryland Board of Physicians to properly investigate and discipline physicians.
[Created on 1/26/2022]

PowerPoint Presentations on Health Policy Issues Relevant to Health Care Reform and a National Single-Payer Health System (HRG Publication #2615)
Drs. Steffie Woolhandler and David Himmelstein, Faculty at the City University of New York at Hunter College and Harvard Medical School, and Research Associates at Public Citizen’s Health Research Group, have prepared an updated large library of slides with data on a range of health policy issues relevant to health care reform, and two more compact slide sets related to a national single-payer health system.
[Created on 1/24/2022]

Press Statement: CMS Follows the Science, Makes the Right Call in Proposing Medicare Coverage for the Alzheimer’s Disease Drug Aducanumab Only for Beneficiaries Who Enroll in a Randomized Clinical Trial (HRG Publication #2614)
Public Citizen applauds CMS for proposing to limit Medicare coverage for aducanumab to beneficiaries with Alzheimer’s disease who enroll in a randomized, controlled clinical trial of the drug.
[Created on 1/11/2022]

2021

Testimony Before the FDA’s Neurological Devices Advisory Committee Meeting Regarding BrainGate LTD’s Ischemic Stroke System (HRG Publication #2613)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Neurological Devices Advisory Committee meeting, Public Citizen urged the Committee to recommend that the FDA not approve the premarket approval application for BrainGate LTD’s Ischemic Stroke System (ISS500) because data from the pivotal phase 3 clinical trial of the device fail to provide a reasonable assurance that the device is effective.
[Created on 12/10/2021]

Testimony Before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding Bardoxolone Methyl for Slowing the Progression of Chronic Kidney Disease Caused by Alport Syndrome (HRG Publication #2612)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Cardiovascular and Renal Drugs Advisory Committee, Public Citizen urged the Committee to recommend that the FDA not approve bardoxolone methyl because the drug has well-established risks of serious harms but the pivotal phase 3 trial of the drug failed to provide substantial evidence that the drug slows the progression of chronic kidney disease in Alport syndrome patients. As a result, a favorable benefit-risk profile has not been established for bardoxolone.
[Created on 12/8/2021]

Forum Article Published in Drug and Therapeutics Bulletin: Mandatory Disclosure of All Pharmaceutical and Medical Device Companies’ Payments to Healthcare Providers: Learning From the USA (HRG Publication #2611)
In a forum article published in Drug and Therapeutics Bulletin, Public Citizen’s Dr. Sidney Wolfe discusses lessons learned from mandatory disclosure of all pharmaceutical and medical device companies’ payments to healthcare providers in the U.S. He also cites the urgent need for the U.K. and other European countries to enact legislation requiring similar disclosures and strengthening whistleblowers protections.
[Created on 12/7/2021]

Testimony Before the FDA’s Antimicrobial Drugs Advisory Committee Regarding the Request for Emergency Use Authorization of Molnupiravir for Treatment of COVID-19 (HRG Publication #2610)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Antimicrobial Drugs Advisory Committee, Public Citizen argued that based on the available clinical and preclinical data for molnupiravir, there is significant uncertainty regarding whether the known and potential benefits of molnupiravir for treating COVID-19 at the proposed dosage outweigh the known and potential risks of the drug.
[Created on 11/30/2021]

Petition to the FDA to Initiate Disqualification Procedures Against Hennepin County Medical Center Researchers and IRB for Unethical High-Risk Clinical Trials (HRG Publication #2609)
Public Citizen petitioned the Food and Drug Administration (FDA) to initiate disqualification proceedings against two researchers at Hennepin County Medical Center (HCMC) in Minneapolis, Minn., for repeatedly and deliberately violating agency regulations intended to protect human subjects when they conducted a series of high-risk clinical trials without obtaining the consent of the subjects. The petition also asked the FDA to take similar action against the HCMC institutional review board (IRB) for violating federal human subjects protection regulations by approving these trials without ensuring that informed consent requirements for such experiments were implemented.
[Created on 11/17/2021]

Press Statement: FDA’s Reckless Decision to Approve Ineffective Alzheimer’s Disease Drug Causing Financial Pain for All Medicare Part B Beneficiaries (HRG Publication #2608)
All Part B Medicare beneficiaries soon will be forced to bear significant financial burden as a direct result of the FDA’s reckless decision to approve aducanumab, a drug that has not been proven to provide any clinically meaningful benefit to Alzheimer’s patients but nevertheless carries an indefensible annual price tag set by Biogen at $56,000 per year for just the drug alone.
[Created on 11/15/2021]

Press Statement: Senate Should Reject Biden’s Recycled FDA Commissioner Pick (HRG Publication #2607)
Dr. Robert Califf must not be allowed to again pass through the revolving door between the FDA and regulated industries. The Senate therefore must reject Califf’s nomination and demand that Biden nominate an individual who has been dedicated to advancing public health — one who unquestionably will place the public interest ahead of the interests of FDA-regulated industries.
[Created on 11/12/2021]

Comments Submitted to the FDA Regarding the Reauthorization of the Prescription Drug User Fee Act (HRG Publication #2606)
In comments submitted to the Food and Drug Administration (FDA), Public Citizen provided specific suggestions to modify the agency’s draft Commitment Letter regarding reauthorization of the Prescription Drug User Fee Act in order to enhance the public health and regulatory focus of the FDA’s drug and biologic review and oversight programs.
[Created on 10/28/2021]

Letter to the FDA Urging That the Composition of the Advisory Committee for the Upcoming Hearing on the Proposal to Withdraw Approval of Hydroxyprogesterone (Makena) Be Fairly Balanced (HRG Publication #2605)
Public Citizen urged the Food and Drug Administration (FDA) to make sure that the advisory committee for a planned agency hearing that will consider the agency’s proposal to withdraw the drug hydroxyprogesterone (Makena), which is approved to reduce the risk of preterm birth, from the market is fairly balanced to ensure the integrity of the hearing process and public trust in the committee’s advice and recommendations.
[Created on 10/27/2021]

Press Statement: Biden Floats Recycled FDA Commissioner Pick Who Is Too Closely Aligned with Big Pharma (HRG Publication #2604)
The country desperately needs a Food and Drug Administration (FDA) leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier – resulting in regulatory capture of the agency by industry. Former FDA Commissioner Robert Califf would not be that leader.
[Created on 10/14/2021]

Testimony Before the FDA’s Vaccines and Related Biological Products Advisory Committee Regarding Booster Doses of the Moderna COVID-19 Vaccine (HRG Publication #2603)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee, Public Citizen highlighted three limitations regarding the clinical trial data submitted in support of Moderna’s request for an emergency use authorization for a booster (third) dose of the company’s COVID-19 vaccine.
[Created on 10/14/2021]

Letter to President Biden Opposing the President and CEO of the Biotechnology Innovation Organization as a Candidate for FDA Commissioner (HRG Publication #2602)
Public Citizen, joined by 25 organizations, sent a letter to President Biden voicing strong opposition to Dr. Michelle McMurry-Heath, President and CEO of the Biotechnology Innovation Organization, as a candidate for FDA Commissioner and urging him to select for this critical federal public health position someone with demonstrated independence from Big Pharma.
[Created on 10/12/2021]

Presentation at the FDA’s Public Meeting on the Recommendations for Prescription Drug User Fee Act (PDUFA) Reauthorization (HRG Publication #2601)
In its presentation at the Food and Drug Administration’s (FDA’s) meeting to discuss the reauthorization of the Prescription Drug User Fee Act (PDUFA) and specifically the draft commitment language soon to be sent to Congress requesting that reauthorization, Public Citizen offered the FDA specific suggestions to modify their commitment language in order to increase the public health and regulatory focus of the FDA’s drug and biologic review programs.
[Created on 9/28/2021]

Testimony Before the FDA’s Vaccines and Related Biological Products Advisory Committee Regarding Booster (Third) Doses of the Pfizer-BioNTech COVID-19 Vaccine (HRG Publication #2600)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee, Public Citizen argued that Pfizer and BioNTech have failed to provide sufficient data to assess the risk-benefit profile of a booster (third) dose of their COVID-19 vaccine in individuals aged 16 or older in the general population.
[Created on 9/17/2021]

Letter to the FDA Urging the Agency Not to Grant 510(k) Premarket Clearance for the TriGUARD 3 Cerebral Embolic Protection Device (HRG Publication #2599)
Public Citizen urged the Food and Drug Administration (FDA) not to grant 510(k) premarket clearance for the TriGUARD 3 Cerebral Embolic Protection Device, which is intended to minimize the risk of stroke during and after transcatheter aortic valve replacement, because data from clinical trials of the device, and comparisons to its predicate device, fail to provide evidence that TriGUARD 3 has a favorable benefit-risk profile or that it is substantially equivalent to its proposed predicate.
[Created on 8/17/2021]

Comments Submitted to the CMS Regarding the National Coverage Determination Analysis for Aducanumab Treatment of Alzheimer’s Disease (HRG Publication #2598)
Public Citizen urged the Centers for Medicare and Medicaid Services (CMS) to issue a national coverage determination that excludes aducanumab from coverage under the Medicare program because there is a lack of scientific evidence that aducanumab provides any meaningful clinical benefit in terms of cognitive function outcomes in Alzheimer’s disease patients and the drug thus is not reasonable and necessary for treatment of such patients.
[Created on 8/11/2021]

Press Statement: Inspector General’s Decision To Investigate FDA’s Inappropriately Close Collaboration With Biogen on the Alzheimer’s Disease Drug Aducanumab Is Long Overdue (HRG Publication #2597)
Public Citizen welcomes the Office of Inspector General’s (OIG’s) announcement today that it finally will launch a review the FDA’s implementation of the accelerated approval pathway for aducanumab and other drugs. Such an independent review is long overdue. We are particularly pleased that the OIG’s evaluation will include an examination of the interactions between the FDA and outside parties during the review and approval process of these drugs.
[Created on 8/4/2021]

Comments Prepared for the CMS Listening Session Regarding the National Coverage Determination Analysis for Aducanumab for Treatment of Alzheimer’s Disease (HRG Publication #2596)
In comments prepared for the Centers for Medicare and Medicaid Services (CMS) listening session regarding the National Coverage Determination analysis for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease, Public Citizen urged CMS to issue a National Coverage Determination that excludes aducanumab from coverage under the Medicare program because there is a lack of scientific evidence that aducanumab provides any meaningful clinical benefit in terms of cognitive function outcomes in Alzheimer’s disease patients and the drug thus is not reasonable and necessary for treatment of such patients.
[Created on 7/27/2021]

Comments Submitted to the FDA Regarding the NDA for Roxadustat for Treating Anemia Due to Chronic Kidney Disease (HRG Publication #2595)
Public Citizen urged the Food and Drug Administration (FDA) not to approve the new drug application (NDA) for roxadustat for treatment of anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis because the drug offers no unique benefits compared to earlier FDA-approved erythropoiesis-stimulating agents but does have greater risks of serious adverse events, including thromboembolic events.
[Created on 7/14/2021]

Follow-up Letter to the HHS OIG Calling for Probe of Acting FDA Commissioner Woodcock’s Role in FDA’s Inappropriately Close Collaboration With Biogen (HRG Publication #2594)
Following Acting Food and Drug Administration (FDA) Commissioner Janet Woodcock’s July 9 belated request to the Department of Health and Human Services (HHS) Office of Inspector General to investigate the “interactions between Biogen and the FDA during the process leading to the decision to approve” aducanumab for treatment of Alzheimer’s disease, Public Citizen urged the OIG to examine Dr. Woodcock’s role in the unprecedented, inappropriately close collaboration between the FDA and Biogen before and after the submission of the company’s marketing application for the drug.
[Created on 7/13/2021]

Press Statement: Woodcock’s Role in Aducanumab’s Approval Must Be Investigated As Part of IG Probe (HRG Publication #2593)
Public Citizen welcomes Food and Drug Administration (FDA) Commissioner Janet Woodcock’s belated request for an independent Inspector General (IG) investigation of her agency’s inappropriately close collaboration with Biogen regarding the Alzheimer’s disease drug aducanumab , as we had urged her to do nearly six months ago. Such an investigation must be broad and determine when Dr. Woodcock first became aware of this collaboration and whether she ever specifically endorsed or facilitated it in any way.
[Created on 7/9/2021]

Follow-up Letter to the HHS Office of Inspector General Requesting an Investigation of the FDA’s Unprecedented and Inappropriately Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2592)
Following the stunning new disclosures in a detailed exposé published by STAT about how Biogen used a Food and Drug Administration (FDA) back channel to win approval for aducanumab for treatment of Alzheimer’s disease, Public Citizen again called on Department of Health and Human Services (HHS) Office of Inspector General to immediately launch a formal investigation to scrutinize the unprecedented and inappropriately close collaboration between the FDA and Biogen before and after the submission of the company’s biologics license application for the new biologic drug aducanumab for treatment of Alzheimer’s disease.
[Created on 6/30/2021]

Follow-up Letter to the HHS Secretary Calling for the Resignations of Acting FDA Commissioner, Other Top Officials Responsible for Indefensible Approval of the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2591)
Following the stunning new disclosures in a detailed exposé published by STAT about how Biogen used a Food and Drug Administration (FDA) back channel to win approval for aducanumab for treatment of Alzheimer’s disease, Public Citizen again called on Department of Health and Human Services (HHS) Secretary Xavier Becerra to immediately request the resignations or seek the removal of the three officials most responsible for the indefensible decision to approve the drug, including Acting Commissioner Janet Woodcock. It is also imperative that the Secretary urge the HHS Office of Inspector General to immediately initiate a thorough investigation of the unprecedented and inappropriately close collaboration between the FDA and Biogen in the analysis of data from the key clinical trials of aducanumab, including the circumstances detailed in the STAT article.
[Created on 6/30/2021]

Letter to the HHS Secretary Calling for the Resignations of Acting FDA Commissioner, Other Top Officials Responsible for Indefensible Approval of the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2590)
Public Citizen called on Secretary of Health and Human Services Xavier Becerra to request the resignations or seek the removal of the three officials most responsible for the agency’s indefensible decision to approve aducanumab for treatment of Alzheimer’s disease despite the lack of evidence that the drug provides any meaningful clinical benefit plus the fact that the drug has a well-documented risk of potentially serious brain injury: Acting FDA Commissioner Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni, and CDER’s Office of Neuroscience Director Billy Dunn.
[Created on 6/16/2021]

Testimony Before the FDA’s Vaccines and Related Biological Products Advisory Committee Regarding COVID-19 Vaccines in Children (HRG Publication #2589)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee, Public Citizen agreed with the need for an Emergency Use Authorization for the Moderna-NIH COVID-19 vaccine for in adolescents aged 12-17 years.
[Created on 6/10/2021]

Presentation at the FDA’s Stakeholder Meeting on the Reauthorization of MDUFA (HRG Publication #2588)
In its presentation at the Food and Drug Administration’s (FDA’s) stakeholder public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027, Public Citizen offers several specific recommendations for strengthening the agency’s oversight of high-risk medical devices to better protect patients from unsafe or ineffective products.
[Created on 6/9/2021]

Testimony Before the FDA’s Pharmacy Compounding Advisory Committee Regarding the List of Drug Products Withdrawn or Removed from the Market Because They Have Been Found to be Unsafe or Not Effective (HRG Publication #2587)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Pharmacy Compounding Advisory Committee, Public Citizen urged that all injectable neomycin products be added to the list of drugs that have been withdrawn or removed from the market because they were deemed unsafe or not effective and that therefore may not be compounded. We also recommended that the FDA implement a new policy of simultaneously initiating the process for updating the list of withdrawn or removed drugs whenever the agency announces that a drug was removed from the market because of safety or effectiveness concerns.
[Created on 6/9/2021]

Op-Ed in Ms. Magazine: States, Medical Regulators and Institutions Must Act to End Physician Sexual Abuse (HRG Publication #2586)
In an op-ed in Ms. Magazine, Dr. Azza AbuDagga, a health researcher with Public Citizen’s Health Research Group, explains why without a serious reckoning and system improvements, even more patients will experience lasting damage by the very individuals they trusted would not harm them.
[Created on 6/8/2021]

Letter to the NIH Regarding Serious Regulatory and Ethical Lapses in a Reckless Seizure Clinical Trial Funded by the Agency (HRG Publication #2585)
Public Citizen shared with the National Institutes of Health (NIH) its request to the Office for Human Research Protections and Food and Drug Administration for immediate investigations into the serious regulatory and ethical lapses in the design and conduct of the NIH-funded Established Status Epilepticus Treatment Trial (ESETT), which involved subjects with status epilepticus (life-threatening prolonged seizures) and was conducted without the informed consent of the subjects. We urged the NIH to promptly conduct an audit of all ongoing or soon-to-be-initiated NIH-funded clinical trials involving critically ill subjects and assess whether usual care clinical practices were rigorously characterized and appropriately incorporated into the design of these trials.
[Created on 6/8/2021]

Letter to the OHRP and FDA Calling for Investigations into Serious Regulatory and Ethical Lapses in a Reckless Seizure Clinical Trial Funded by NIH (HRG Publication #2584)
Public Citizen called on the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) to immediately investigate the National Institute of Health (NIH)-funded Established Status Epilepticus Treatment Trial (ESETT), which involved subjects with status epilepticus (life-threatening prolonged seizures) and was conducted without the informed consent of the subjects. The troubling flaws in ESETT’s design exposed some of the subjects to unacceptable and avoidable risks and thus violated regulatory and ethical norms for human research.
[Created on 6/8/2021]

Press Statement: FDA’s Decision to Approve Aducanumab for Alzheimer’s Disease Shows Reckless Disregard for Science, Severely Damages Agency’s Credibility (HRG Publication #2583)
The Food and Drug Administration (FDA’s) decision to approve aducanumab for treatment of Alzheimer’s disease shows a stunning disregard for science and eviscerates the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
[Created on 6/7/2021]

Comments Submitted to the FDA Regarding the Biologics License Application for Teplizumab for Delaying of Type 1 Diabetes Mellitus in At-Risk Individuals (HRG Publication #2582)
Public Citizen urged the Food and Drug Administration (FDA) not to approve the biologics license application for teplizumab for the proposed indication for the delay of clinical type 1 diabetes mellitus in at-risk individuals because of the lack of substantial evidence of efficacy, concerns about safety, and a lack of biocomparability between the product studied in clinical trials and the one that is intended for commercial use.
[Created on 5/26/2021]

Comments on the FDA’s Proposal to Exclude Four Bulk Drug Substances From the 503B Bulks List for Pharmacy Compounding by Outsourced Facilities (HRG Publication #2581)
Public Citizen strongly supports the Food and Drug Administration’s (FDA’s) proposal to exclude four bulk drug substances from the list of bulk drug substances for which there is a clinical need under Section 503B of the Federal Food, Drug, and Cosmetic Act for pharmacy compounding by outsourcing facilities.
[Created on 5/24/2021]

Letter to the Secretary of Health and Human Services and the CDC Director Regarding the Dangerously Inadequate Process Used by the CDC to Update Its Guidelines for Wearing Masks (HRG Publication #2580)
Public Citizen expressed serious concern regarding the dangerously inadequate process undertaken by the Centers for Disease Control and Prevention (CDC) to develop and issue the agency’s revised guidance on mask wearing by people who are fully vaccinated for COVID-19. Among the most troubling aspects of the agency’s decision to loosen its mask-wearing guidelines was the failure of the agency to engage in a transparent, consultative process with the multiple affected stakeholders before making such a consequential public health decision in the midst of the ongoing COVID-19 pandemic.
[Created on 5/18/2021]

Letter to the FDA Urging the Agency Not to Approve the Biologics License Application for Donislecel for the Treatment of “Brittle” Type 1 Diabetes (HRG Publication #2579)
Public Citizen urged the Food and Drug Administration (FDA) to not approve the biologics license application for donislecel (purified allogeneic deceased donor pancreas derived Islets of Langerhans) for the treatment of “brittle” type 1 diabetes because there is not adequate evidence showing that this product has a favorable benefit-risk profile and there are serious concerns regarding the quality controls for ensuring the potency and purity of each specific lot of donislecel.
[Created on 4/30/2021]

Letter to the FDA Urging the Agency to Promptly Convene an Outside Expert Advisory Panel To Revisit the Decision to Approve Remdesivir for Treatment of COVID-19 (HRG Publication #2578)
Public Citizen called on the Food and Drug Administration (FDA) to promptly convene an external expert advisory panel to evaluate whether the approval of the antiviral COVID-19 treatment remdesivir should be rescinded. The FDA approved the drug despite being aware of evidence from a major clinical trial that raised substantial doubts about whether the drug provides clinically meaningful benefit and without convening a public advisory committee meeting, as the agency routinely does prior to approving such new drugs.
[Created on 4/21/2021]

Comments Presented at an FDA Listening Session Regarding FDA Enforcement of Regulations Applicable to Stem Cell and Regenerative Medicine Clinics that are Administering Unapproved Human Cells, Tissues, and Cellular and Tissue-Based Products (HRG Publication #2577)
In order to protect patients and public health, the Food and Drug Administration (FDA) after May 31, 2021, must take swift and aggressive enforcement actions against establishments — including self-identified stem cell and regenerative medicine clinics — engaged in the manufacturing or marketing of illegal, unapproved human cells, tissues, and cellular and tissue-based products. Such action to stop the manufacturing, marketing, and use of these unapproved, illegal products that have the potential to cause serious harm to patients but have not been proven to be effective and raise false hopes for patients is long overdue.
[Created on 4/13/2021]

Petition to the FDA to Amend the List of Drug Products That Were Withdrawn or Removed From the Market Because They Were Deemed Unsafe of Ineffective (HRG Publication #2576)
Public Citizen petitioned the Food and Drug Administration (FDA) to promptly add the weight loss drug lorcaserin and injectable forms of the antibiotic bacitracin to its official list of drugs withdrawn or removed from the market because they were deemed unsafe or ineffective, in order to prevent pharmacy compounding of these banned drugs. We also urged the agency to implement a new policy of simultaneously initiating the process for updating the list of withdrawn drugs whenever the agency announces that a drug was removed from the market because of safety or effectiveness concerns.
[Created on 4/13/2021]

Letter to the Secretary of Health and Human Services Requesting an Investigation of the FDA’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2575)
Public Citizen called on Secretary of Health and Human Services Xavier Becerra to ask his department’s Office of Inspector General to immediately investigate the unprecedented and inappropriate close collaboration between the Food and Drug Administration (FDA) and Biogen regarding the company’s application for approval of the Alzheimer’s disease drug aducanumab. The economic costs of the aducanumab to the Medicare program would be extraordinary and only justifiable for a drug that has definitive evidence of significant, clinically meaningful benefit.
[Created on 4/1/2021]

Report: Ranking of the Rate of State Medical Boards’ Serious Disciplinary Actions, 2017-2019 (HRG Publication #2574)
The purpose of this report is to examine the extent to which state medical boards are taking actions to protect the public from licensed physicians who injure patients or behave inappropriately or illegally. Using state-level data on serious disciplinary actions from the National Practitioner Data Bank ’s Public Use Data File, we compare the performance of the state medical boards based on the annual average number of serious disciplinary actions taken by the boards per 1,000 licensees during 2017, 2018, and 2019.
[Created on 3/31/2021]

Testimony before the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Tanezumab for Treatment of Osteoarthritis (HRG Publication #2573)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve tanezumab for treatment of osteoarthritis because the drug fails to provide clinically meaningful benefit compared with either placebo or oral non-steroidal anti-inflammatory drugs, but does dramatically increase the rates of rapidly progressive osteoarthritis and of total joint replacements in a dose- and duration-dependent manner.
[Created on 3/24/2021]

Press Statement: FDA Must Reject Tanezumab as a Treatment for Osteoarthritis Due to Unacceptable Dangers, Little to No Benefit (HRG Publication #2572)
The Food and Drug Administration (FDA’s) pending decision regarding tanezumab for treatment of osteoarthritis should not even be a close call. A drug like tanezumab that accelerates the joint destruction of the underlying osteoarthritis disease it is intended to treat but lacks any evidence of clinically meaningful benefit in comparison to use of a placebo or oral anti-inflammatory drugs obviously should never be approved by the FDA.
[Created on 3/23/2021]

Press Statement: NIAID’s Statement on AstraZeneca’s COVID-19 Vaccine is Remarkable and Troubling (HRG Publication #2571)
This remarkable NIAID statement once again highlights the dangers of disseminating critical scientific information by company press release. There is no better way to undermine public confidence in a vaccine than for the manufacturer to make comments overstating the product’s effectiveness or safety and to then have to backtrack.
[Created on 3/23/2021]

Comments for the FDA’s March 24-25, 2021 Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Biologics License Application for the Osteoarthritis Drug Tanezumab (HRG Publication #2570)
Public Citizen urges the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to recommend that the Food and Drug Administration (FDA) not approve the biologics license application for tanezumab because the totality of the evidence from three published pivotal phase 3 randomized clinical trials demonstrates that the drug fails to provide clinically meaningful benefit but does dramatically increase the rates of rapidly progressive osteoarthritis and other types of serious joint damage and of total joint replacements in a dose- and duration-dependent manner. As a result, the serious risks of the drug far outweigh its benefits.
[Created on 3/10/2021]

Testimony Before the FDA’s Vaccines and Related Biological Products Advisory Committee Regarding the EUA of the Janssen COVID-19 Vaccine (HRG Publication #2569)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee, Public Citizen agreed with the need for an Emergency Use Authorization (EUA) for the Janssen COVID-19 vaccine, but raised questions about whether and when placebo-group subjects in the clinical trials of the Pfizer, Moderna, and Janssen COVID-19 vaccines would be notified of their status and offered a COVID-19 vaccine.
[Created on 2/26/2021]

Letter to the Editor of JAMA Neurology Regarding Lack of Clarity Regarding the Disclosure of Financial Conflicts of Interest (HRG Publication #2568)
In a letter to the editor of JAMA Neurology, Public Citizen expressed concern about the apparent lack of clarity regarding the financial conflicts of interest disclosed by one of the authors of the Viewpoint article titled “Possible Consequences of the Approval of a Disease-Modifying Therapy for Alzheimer Disease,” that was published in the February 2021 issue of JAMA Neurology. The article discussed the investigational drug aducanumab for treatment of Alzheimer’s disease.
[Created on 2/23/2021]

Press Statement: FDA Must Demand a New Clinical Trial of Experimental Alzheimer’s Disease Treatment Following Inappropriate Collaboration (HRG Publication #2567)
The FDA must reject the current application for aducanumab and demand that Biogen and Eisai conduct another large, placebo-controlled clinical trial before giving further consideration to approving aducanumab to treat Alzheimer’s disease. Additional flawed statistical analyses of data from the previously conducted trials of the drug will not be sufficient to establish that the drug is effective.
[Created on 1/29/2021]

Follow-up Letter to the FDA’s Acting Commissioner Regarding the Agency’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2566)
Public Citizen urged the FDA’s new Acting Commissioner to endorse our call for the Department of Health and Human Services’ Office of Inspector General to investigate the unprecedented and inappropriate close collaboration between the FDA and Biogen before and after the submission of the company’s biologics license application (BLA) for the new drug aducanumab for treatment of Alzheimer’s disease. We also urged her to publicly disclose whether she was ever made aware of, or whether she ever endorsed or facilitated in any way, the FDA’s close collaboration with Biogen prior to her assignment to Operation Warp Speed.
[Created on 1/28/2021]

Press Statement: Dr. Kessler’s Expertise, Experience is Needed at Operation Warp Speed (HRG Publication #2565)
Dr. Kessler’s selection as chief advisor of Operation Warp Speed importantly matches his public health skills with the greatest international public health crisis of our lifetime, the coronavirus pandemic. The necessary interface between Operation Warp Speed and the FDA will benefit under his leadership as will the entire process of development, manufacturing, and distribution of COVID-19 vaccines, therapeutics and diagnostic tests.
[Created on 1/15/2021]

2020

Letter to Senior FDA and NIH officials Urging Changes to the Fact Sheets for Recipients of the Recently Authorized COVID-19 Vaccines (HRG Publication #2564)
Public Citizen strongly urged senior Food and Drug Administration (FDA) and National Institutes of Health (NIH) officials to promptly update the Pfizer-BioNTech and Moderna-NIH COVID-19 vaccine fact sheets for vaccine recipients and caregivers to include statements advising vaccine recipients to continue to follow the proven public health measures of mask wearing and social distancing.
[Created on 12/22/2020]

Testimony Before the FDA’s Vaccines and Related Biological Products Advisory Committee Regarding the EUA of the Moderna-NIH COVID-19 Vaccine (HRG Publication #2563)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee, Public Citizen agreed with the need for an Emergency Use Authorization (EUA) for the Moderna-NIH COVID-19 vaccine, but argued that the fact sheet for recipients of the vaccine should advise recipients to continue following public health guidelines for wearing masks and other personal protective equipment and for social distancing to prevent transmission of the coronavirus.
[Created on 12/17/2020]

Testimony Before the FDA’s Vaccines and Related Biological Products Advisory Committee Regarding the EUA of the Pfizer-BioNTech COVID-19 Vaccine (HRG Publication #2562)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee, Public Citizen agreed with the need for an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, but argued that for ethical reasons, subjects in the placebo group for the pivotal clinical trial should be offered the opportunity to be unblinded, receive the Pfizer vaccine, and continue to be followed in the trial for long-term safety and efficacy assessments.
[Created on 12/10/2020]

Letter to the FDA Regarding the Agency’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2561)
Public Citizen urged the Food and Drug Administration (FDA) to endorse our call for the Department of Health and Human Services’ Office of Inspector General to investigate the unprecedented and inappropriate close collaboration between the FDA and Biogen before and after the submission of the company’s biologics license application (BLA) for the new drug aducanumab for treatment of Alzheimer’s disease. We also urged the agency not to approve the BLA for aducanumab given the clear lack of substantial evidence that the drug is effective for treating Alzheimer’s disease.
[Created on 12/9/2020]

Letter to the HHS Office of Inspector General Requesting an Investigation of the FDA’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2560)
Public Citizen called on the Department of Health and Human Services’ (HHS’) Office of Inspector General to immediately launch a formal investigation into the unprecedented and inappropriate close collaboration between the Food and Drug Administration (FDA) and Biogen before and after the submission of the company’s biologics license application (BLA) for the new drug aducanumab for treatment of Alzheimer’s disease. This close collaboration dangerously compromised the independence and objectivity of FDA senior staff and clinical reviewers who were involved in the review of Biogen’s BLA for aducanumab and key data from clinical trials of the drug.
[Created on 12/9/2020]

Large and Compact PowerPoint Presentations on Health Policy Issues Relevant to Health Care Reform (HRG Publication #2559)
Drs. Steffie Woolhandler and David Himmelstein, Faculty at the City University of New York at Hunter College and Harvard Medical School, and Research Associates at Public Citizen’s Health Research Group, have prepared a large library of slides with data on a range of health policy issues relevant to health care reform, and two more compact slide sets related to a national single-payer health system.
[Created on 12/8/2020]

Press Release: Nation’s Leading Health Experts Urge GSA Administrator to Immediately Begin Presidential Transition (HRG Publication #2558)
Amid surging COVID-19 cases nationwide, over 140 former public health officials, public health and medical school deans, and public health and medical experts and researchers are sounding the alarm today in a letter to General Services Administration (GSA) Administrator Emily Murphy.
[Created on 11/19/2020]

Press Statement: Disseminating Preliminary, Incomplete COVID-19 Vaccine Study Results by Press Release Represents Bad Science (HRG Publication #2557)
The release of preliminary and incomplete clinical trial data by press release to the public is bad science. Until the trial results are independently reviewed and scrutinized by staff at the U.S. Food and Drug Administration and the independent experts on the agency’s Vaccines and Related Biological Products Advisory Committee, enthusiasm for the apparently promising interim results announced by Pfizer and BioNTech must be tempered.
[Created on 11/9/2020]

Testimony Before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee Regarding Aducanumab for Treatment of Alzheimer’s Disease (HRG Publication #2556)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Peripheral and Central Nervous System Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve aducanumab for treatment of Alzheimer’s disease because there is not substantial evidence of effectiveness.
[Created on 11/6/2020]

Press Statement: FDA Approval of Aducanumab to Treat Alzheimer’s Disease Would Be a Reckless Disregard for Science, Damage Agency’s Credibility (HRG Publication #2555)
The overall tenor of the Food and Drug Administration’s (FDA’s) briefing document for the Peripheral and Central Nervous System Drugs Advisory Committee meeting regarding aducanumab reveals that the agency is actively working hand-in-hand with Biogen, the maker of the drug, to rush to market an unproven biologic drug to treat Alzheimer’s disease that could bankrupt our health care system.
[Created on 11/5/2020]

Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding a Hydrocodone-Acetaminophen-Promethazine Combination Product (HRG Publication #2554)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve a hydrocodone-acetaminophen-promethazine combination product for the short-term management of acute post-operative pain severe enough to require an opioid analgesic and the prevention of opioid-induced nausea and vomiting in patients who are at risk for or have a history of nausea and vomiting because an unfavorable risk-benefit profile.
[Created on 11/2/2020]

Comments to the FDA Endorsing a Citizen Petition Submitted by Knowledge Ecology International Requesting a Ban on the Use of Background Music During the Presentation of Risks in Direct-to-Consumer Drug Broadcast Advertising (HRG Publication #2553)
Public Citizen submitted comments to the Food and Drug Administration (FDA) endorsing Knowledge Ecology International’s (KEI’s) recent citizen petition requesting that the FDA amend the regulations governing prescription-drug advertisements to include a provision that bans background music from the presentation of the risks section of direct-to-consumer (DTC) broadcast prescription drug ads. In addition, we urged the FDA to go further by (a) promptly issuing a long-overdue final rule — mandated by the Food and Drug Administration Amendments Act of 2007 — amending the regulations governing DTC ads for prescription drugs to require that the disclosure of risk information in the major risk statement of DTC broadcast ads be clear, conspicuous, and neutral, and (b) including additional elements in that rule beyond the change sought by KEI.
[Created on 10/27/2020]

Presentation at the FDA’s Public Kickoff Meeting on the Reauthorization of MDUFA (HRG Publication #2552)
In its presentation at the Food and Drug Administration’s (FDA’s) kickoff public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Act (MDUFA) for fiscal years 2023 through 2027, Public Citizen expressed its long-standing strong opposition to the FDA’s user fee programs and offered several recommendations for strengthening the agency’s oversight of high-risk, permanently implanted medical devices to better protect patients from unsafe or ineffective products.
[Created on 10/27/2020]

Comments on the FDA’s Proposed Rule Regarding the “Intended Uses” of Marketed Drugs and Medical Devices (HRG Publication #2551)
Public Citizen strongly supports the Food and Drug Administration’s (FDA’s) proposal to amend the sections of its regulations that describe the types of evidence relevant to determining the intended uses of a marketed drug or medical device under the Food, Drug, and Cosmetic Act. The FDA’s authority to make such determinations is critically important to the agency’s core mission to protect public health by ensuring that all marketed drugs and medical devices are safe and effective for their intended uses.
[Created on 10/23/2020]

Testimony Before the FDA’s Vaccines and Related Biological Products Advisory Committee Regarding the Development, Authorization, and Licensure of Vaccines to Prevent COVID-19 (HRG Publication #2550)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee, Public Citizen urged the committee to recommend against issuing an Emergency Use Authorization (EUA) for any vaccine to prevent COVID-19 because the safety and efficacy standards for a vaccine EUA are inadequate.
[Created on 10/22/2020]

Letter to OHRP Calling for Additional Agency Actions to Address Alarming Ethical and Regulatory Lapses in NIH-Funded Sepsis Clinical Trial (HRG Publication #2549)
In a letter to the Office for Human Research Protections (OHRP), Public Citizen criticized the agency for putting hundreds of seriously ill sepsis patients at risk by not suspending enrollment in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) trial, which was funded by the National Institutes of Health (NIH), while much needed changes were made to the trial’s design and consent form to address alarming ethical and regulatory lapses.
[Created on 10/13/2020]

Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding the Combination Drug Olanzapine/Samidorphan Intended to Treat Schizophrenia and Bipolar Disorder (HRG Publication #2548)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen argued against approval of the combination drug olanzapine/samidorphan, which is intended to treat schizophrenia and bipolar disorder, because the samidorphan component is only marginally effective in decreasing the weight gain seen with olanzapine, fails to improve many other indicators of metabolic health, and increases the risk of opioid overdose.
[Created on 10/9/2020]

Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding an Oral Amphetamine Product Intended to be Abuse-Deterrent (HRG Publication #2547)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen argued against approval of AR19, an oral amphetamine product that is intended to be abuse-deterrent, because studies show that the drug is not expected to reduce abuse by injection or intranasal routes.
[Created on 10/8/2020]

Press Statement: Trump Administration’s Interference with the FDA’s Coronavirus Vaccine Guidance Will Cost American Lives (HRG Publication #2546)
The decision by Trump and his minions to suppress critical science-based FDA guidelines for the emergency use authorization (EUA) of a COVID-19 vaccine represents the latest but most dangerous politicization of the U.S. public health response to the catastrophic pandemic.
[Created on 10/6/2020]

Comments on the FDA’s Proposal to Exclude 19 Bulk Drug Substances From the 503B Bulks List for Pharmacy Compounding by Outsourced Facilities (HRG Publication #2545)
Public Citizen strongly supports the Food and Drug Administration’s (FDA’s) proposal to exclude 19 bulk drug substances from the list of bulk drug substances for which there is a clinical need under Section 503B of the Federal Food, Drug, and Cosmetic Act for pharmacy compounding by outsourcing facilities.
[Created on 9/29/2020]

Letter to the Massachusetts Department of Labor Standards Providing Comments on the Agency’s Proposed COVID-19 Workplace Safety Regulations (HRG Publication #2544)
Public Citizen expressed support for the Massachusetts Department of Labor Standards efforts to implement COVID-19 Workplace Safety Regulations. However, because of concerns that the proposed regulations lacks key provisions that are essential for adequately protecting workers in Massachusetts from risk of infection with the severe acute respiratory syndrome coronavirus 2, we recommended several additions to the proposed regulations.
[Created on 9/11/2020]

Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding Reformulated Oxycontin (HRG Publication #2543)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen emphasized that there is a serious question as to whether introducing abuse deterrent opioids such as reformulated Oxycontin (oxycodone) may have worsened overall public health.
[Created on 9/11/2020]

Letter to the Oregon OSHA Providing Comments on the Agency’s Draft COVID-19 Temporary Standard (HRG Publication #2542)
Public Citizen expressed support for the Oregon Occupational Safety and Health’s (Oregon OSHA’s) efforts to implement a COVID-19 Temporary Standard. However, because of concerns that the proposed Temporary Standard lacks key provisions that are essential for adequately protecting workers in Oregon from risk of infection with the severe acute respiratory syndrome coronavirus 2, we recommended several additions to the proposed standard.
[Created on 9/3/2020]

Letter to the Secretary of Transportation Calling for an Emergency Rule That Would Require Airports and Airlines to Implement Mask Wearing Mandates (HRG Publication #2541)
Public Citizen, joined by 22 other organizations, urged the Secretary of Transportation to immediately grant FlyersRights.org’s August 4 petition for an emergency rule that would require all air carriers and airports to mandate the wearing of masks for all persons inside of airports and airplanes at all times. The requested emergency rule is a simple, commonsense measure for mitigating the spread of COVID-19 among airplane passengers and crew members, airport workers, and other airport visitors.
[Created on 9/1/2020]

Press Release: Public Citizen Sues FDA for Failing to Respond to Petition to Ban Surgical Device Seprafilm (HRG Publication #2540)
Public Citizen today sued the U.S. Food and Drug Administration (FDA) over its failure to act on a five-year-old petition asking the agency to ban the dangerous and ineffective medical device, Seprafilm, which continues to put patients at risk.
[Created on 8/27/2020]

Press Release: NIH Agrees With Public Citizen, Will Conduct Preclinical Trials of the Potential COVID-19 Treatment GS-441524 (HRG Publication #2539)
The National Institutes of Health (NIH) will expeditiously conduct preclinical studies of GS-441524 as a treatment for COVID-19 and will make the results readily available to the scientific community, as requested in a letter sent to the agency by Public Citizen.
[Created on 8/24/2020]

Press Statement: Blatant Politicization of the FDA Hurts Its Credibility (HRG Publication #2538)
Make no mistake – The FDA’s decision to grant an emergency use authorization for COVID-19 convalescent plasma on the eve of the Republican National Convention represents the most blatant politicization of FDA decision making in history.
[Created on 8/24/2020]

Letters to HHS/HRSA, FSMB and State Medical Boards Calling to Implement Recommendations to Protect Patients from Physician Sexual Abuse (HRG Publication #2537)
Public Citizen urged the Secretary of the U.S. Department of Health and Human Services (HHS), the Administrator of the Health Resources and Services Administration (HRSA), leaders of the Federation of State Medical Boards (FSMB) and each of 71 state medical and osteopathic boards in the U.S. to implement recommendations to curb physician sexual abuse of patients. The recommendations stemmed from a comprehensive Public Citizen report released in May that analyzed 15-year data of physicians reported to the National Practitioner Data Bank due to sexual misconduct.
[Created on 8/19/2020]

Letter to the Secretary of Health and Human Services and Senior FDA and NIH Officials Opposing Emergency Use Authorization for Any COVID-19 Vaccine (HRG Publication #2536)
Public Citizen strongly urged the Department of Health and Human Services and the Food and Drug Administration (FDA) to promptly end the current dangerous consideration being given to issuing Emergency Use Authorizations (EUAs) for COVID-19 vaccines. If the FDA were to issue an EUA and thus allow premature widespread use of COVID-19 vaccines, a significant number of people inevitably would choose not to be vaccinated under such uncertain circumstances, which would significantly impair the country’s response to the ongoing public health crisis caused by the coronavirus pandemic.
[Created on 8/6/2020]

Letter to Gilead and Senior Federal Health Officials Calling for Immediate Study of the Antiviral Drug GS-441524 as a Potential Treatment for COVID-19 (HRG Publication #2535)
In a letter to leadership of Gilead Sciences, Inc., the National Institutes of Health, the Food and Drug Administration, and the Biomedical Advanced Research and Development Authority, Public Citizen and two scientists specializing in cancer drug development offer a detailed summary of scientific evidence suggesting that the experimental antiviral drug GS-441524 may be a better drug than the closely-related drug remdesivir to treat COVID-19. The letter asks Gilead and the federal agencies either to work collaboratively to promptly pursue the development of GS-441524 as a treatment for COVID-19 or to publicly explain and provide evidence as to why doing so is not scientifically or medically feasible.
[Created on 8/4/2020]

Letter to the FDA Criticizing the Agency’s Response to Public Citizen’s Report on Implanted Spinal Cord Stimulators for Pain Relief (HRG Publication #2534)
Public Citizen expressed great disappointment regarding the Food and Drug Administration’s (FDA’s) recent letter reacting to the organization’s June 10, 2020, report, Implanted Spinal Cord Stimulators for Pain Relief: Illustrating the FDA’s Dangerously Lax Oversight of High-Risk Implantable Medical Devices. The terse non-responsive letter from the FDA was utterly dismissive about the detailed observations, concerns, and recommendations presented in the report and lacked any hint of thoughtful introspection about weaknesses in the agency’s oversight of high-risk implantable medical devices and the potential opportunities to address those weaknesses to better protect patients treated with these devices.
[Created on 7/29/2020]

Presentation at the FDA’s Public Meeting on the Reauthorization of PDUFA (HRG Publication #2533)
In its presentation at the Food and Drug Administration’s (FDA’s) kickoff public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2023 through 2027, Public Citizen expressed its long-standing strong opposition to the FDA’s user fee programs and offered several recommendations for strengthening the agency’s oversight of prescription drugs to better protect patients from unsafe or ineffective products.
[Created on 7/23/2020]

Letter to President Trump and Vice President Pence Urging Them to Relinquish Control of the Federal Coronavirus Response to Public Health and Medical Experts (HRG Publication #2532)
Public Citizen, joined by 18 organizations, called upon President Trump and Vice President Pence to immediately step aside from any further role in leading or communicating about the federal response to the pandemic and to delegate full operating authority over the response to senior professional public health and medical experts within the agencies of the U.S. Public Health Service.
[Created on 7/14/2020]

Letter to the Secretary of Health and Human Services, FDA Commissioner and NIH Director Regarding Coronavirus Human Challenge Studies (HRG Publication #2531)
Public Citizen requested that the Department of Health and Human Services publicly announce that the Food and Drug Administration (FDA) will not permit and the National Institutes of Health (NIH) will not support any clinical trials during which human subjects — after immunization with an investigational severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine — would be intentionally infected with the novel coronavirus causing the coronavirus disease 2019 (COVID-19) pandemic.
[Created on 7/6/2020]

Follow-up Letter to the American Hospital Association Urging the Organization to Condemn Efforts by Hospitals to Muzzle Health Care Workers For Speaking Out About the Coronavirus Pandemic (HRG Publication #2530)
Public Citizen, joined by 45 organizations and labor unions, reiterated demands that the AHA publicly denounce any threats of disciplinary action for speaking out during this pandemic and call on its member hospitals to encourage health care workers to speak freely about coronavirus patient caseloads, dwindling hospital supplies, and any other challenges that should be immediately addressed.
[Created on 6/24/2020]

Petition to the FDA to Require a Black-Box Warning for Commonly Used Type 2 Diabetes Drugs Known as SGLT2 Inhibitors (HRG Publication #2529)
Public Citizen petitioned the Food and Drug Administration (FDA) to add a black-box warning to the product labeling for the commonly used Type 2 diabetes drugs known as SGLT2 inhibitors, as they can lead to potentially fatal diabetic ketoacidosis in Type 1 diabetes patients for whom the drugs are not approved.
[Created on 6/24/2020]

Letter to the Virginia Safety and Health Codes Board Urging Adoption of an Emergency Temporary Standard to Protect Workers from COVID-19 (HRG Publication #2528)
Public Citizen strongly urged the Virginia Safety and Health Codes Board to adopt, with one important change, a proposed emergency temporary standard to protect workers in Virginia from COVID-19.
[Created on 6/22/2020]

Press Statement: Trump Should Cancel Dangerous Rally (HRG Publication #2527)
Trump has chosen to disregard the advice and guidelines of his own public health experts and proceed with a large indoor rally. This reckless decision undoubtedly will fuel the spread of the coronavirus and cause numerous deaths among rallygoers and the broader community in which they live.
[Created on 6/19/2020]

Report: Implanted Spinal Cord Stimulators for Pain Relief – Illustrating the FDA’s Dangerously Lax Oversight of High-Risk Implantable Medical Devices (HRG Publication #2526)
In a report delivered to the Commissioner of the Food and Drug Administration (FDA) and key congressional committees, Public Citizen documented the FDA’s dangerously lax regulatory oversight of high-risk implanted spinal cord stimulators for pain relief, which has resulted in unnecessary harm to patients. The FDA’s regulatory oversight of implanted spinal cord stimulators for pain relief has had serious, wide-ranging deficiencies for several decades and is emblematic of what’s wrong with the agency’s oversight of medical devices.
[Created on 6/10/2020]

Supplement to the Petition to the DEA and FDA to Reschedule the Opioid Tramadol From Schedule IV to Schedule II (HRG Publication #2525)
Public Citizen submitted a supplement to its November 2019 petition to the Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) to reschedule the opioid tramadol from the weakly controlled schedule IV under the Controlled Substances Act to the more tightly controlled schedule II because it is overprescribed, often misused, highly addictive and potentially deadly. The supplement adds new data from a careful study of the FDA’s Adverse Event Reporting System which revealed that tramadol use correlates with severe adverse events, including death, at rates similar to most other schedule II opioids.
[Created on 5/28/2020]

Press Release: Top 12 Things Trump Did to Speed the Pandemic (HRG Publication #2524)
Since the onset of the coronavirus pandemic, President Donald Trump’s chaotic and incompetent response has fueled the spread of the virus in the U.S. and beyond, causing tens of thousands of preventable deaths. We identify the top 12 things Trump did to speed the pandemic and push the death count higher.
[Created on 5/27/2020]

15-Year Summary of Sexual Misconduct by U.S. Physicians Reported to the National Practitioner Data Bank, 2003 ― 2017; In-Depth, Updated Evidence on White Coat Betrayal (HRG Publication #2523)
A new updated, comprehensive report by Public Citizen showed that only 1,354 U.S. doctors had faced reportable sanctions or malpractice payments due to sexual misconduct over 15 years (from 2003 through 2017). Of those, 38% continued to hold active licenses and clinical privileges in the states where they faced these consequences. The report provides numerous examples of sexual misconduct by doctors and an in-depth discussion of the reasons behind the persistence of this public health problem, and offers recommendations for addressing it.
[Created on 5/26/2020]

Letter to Gilead Sciences Regarding the Emergency Use Authorization Granted by the FDA for Remdesivir (HRG Publication #2522)
Public Citizen urged Gilead Sciences to immediately either (a) release the data regarding the safety and efficacy of remdesivir on which the Food and Drug Administration (FDA) relied in granting the company’s Emergency Use Authorization request for emergency use of remdesivir for treatment of hospitalized COVID-19 patients, or (b) inform the FDA that the company consents to the FDA’s release of such information in response to a Freedom of Information Act request submitted by Public Citizen.
[Created on 5/5/2020]

Press Statement: Please Shut Up, Mr. Trump (HRG Publication #2521)
Enough is enough. Trump’s dangerous suggestion that injections of disinfectants might be useful for treating coronavirus infections is among the stupidest ideas to emerge from his mouth during the nightly White House carnival shows.
[Created on 4/24/2020]

Op-Ed in the Rome News-Tribune: CON: Dr. Trump’s Snake Oil Might Cost Lives (HRG Publication #2520)
In an op-ed in the Rome News-Tribune, Dr. Michael Carome, director of Public Citizen’s Health Research Group, explains why President Trump’s reckless promotion of chloroquine and hydroxychloroquine as a “game changing” treatment for COVID-19 is so dangerous.
[Created on 4/23/2020]

Press Statement: Leading Public Health Expert and White House Coronavirus Response Coordinator Undermines Her Credibility (HRG Publication #2519)
Although most Americans expect President Donald Trump to lie whenever he opens his mouth and speaks about the coronavirus pandemic, they generally have viewed the public health experts serving on the White House Coronavirus Task Force, like Ambassador Birx and Dr. Anthony Fauci, as respected, credible voices. But Birx has undermined her credibility by falsely claiming that the U.S. has one of the lowest coronavirus mortality rates in the entire world.
[Created on 4/22/2020]

Press Statement: Trump’s Plan to Reopen the Economy Will Expand the Public Health and Economic Catastrophe (HRG Publication #2518)
It’s absurd to even think about reopening businesses — including large venues such as sports arenas, movie theaters and restaurants — or allowing nonessential travel in the absence of a robust federal testing and tracing program for detecting all coronavirus infections.
[Created on 4/17/2020]

Press Statement: No Trump, the U.S. Casualties From the Coronavirus Pandemic Have Not Been ‘Very Low’ (HRG Publication #2517)
Trump’s habitual disregard for the facts and his fantasies about his administration’s grossly negligent pandemic response pose an ongoing mortal danger to U.S. citizens. The facts, again, remain Trump’s biggest albatross: The per capita numbers of confirmed COVID-19 cases and deaths in the U.S. compared with other countries are very high.
[Created on 4/14/2020]

Press Statement: Stockpile Depleted; Trump Administration’s Bungling and Delays in Pandemic Response Will Be Deadly (HRG Publication #2516)
It must have been obvious to Trump officials several weeks ago that the Strategic National Stockpile’s supply of critically needed medical supplies would be exhausted by now. With that knowledge, any competent administration would have immediately invoked the Defense Production Act and ordered factories across the nation to begin mass production of these medical supplies for distribution by the federal government.
[Created on 4/2/2020]

Press Statement: The Public Deserves Better Than the FDA’s Belated Zantac (Ranitidine) Ban (HRG Publication #2515)
Although Public Citizen welcomes this long-overdue action, the Food and Drug Administration’s (FDA’s) lengthy delay in seeking the removal of ranitidine products from the market is another glaring example of agency foot-dragging in response to a serious safety concern about a medical product.
[Created on 4/1/2020]

Letter to the American Hospital Association Urging the Organization to Condemn Efforts by Hospitals to Muzzle Doctors and Nurses For Speaking Out About the Coronavirus Pandemic (HRG Publication #2514)
Public Citizen, joined by 53 organizations and labor unions, demanded that the American Hospital Association publicly denounce any efforts to muzzle health care professionals with threats of disciplinary action for speaking out about coronavirus patient caseloads and dwindling hospital supplies needed to care for such patients. Attempts to cover up medical supply shortages by muzzling health care workers who are on the front lines of fighting the COVID-19 pandemic are reprehensible and reckless and endanger public health.
[Created on 3/27/2020]

Press Statement: Thanks to Trump’s Dangerously Inept Response, U.S. Coronavirus Cases Have Almost Eclipsed Those in China (HRG Publication #2513)
For weeks, Trump repeatedly has bragged about the “tremendous” response of his administration to the pandemic. But Trump’s self-laudatory claims are belied by facts as the U.S. is about to reach a grim milestone: The number of cases of coronavirus infection in the country will eclipse the number in China, the country where the pandemic began.
[Created on 3/26/2020]

Press Statement: Trump’s Financial Conflicts of Interest Endanger Public Health (HRG Publication #2512)
With the country now facing an unprecedented public health crisis, the American people cannot help but wonder whether Trump’s alarming proposal to ignore the advice of public health experts and soon loosen federal guidelines on social distancing that are intended to save lives and prevent our health care system from collapsing is motivated by his desire to minimize his own personal business financial losses.
[Created on 3/24/2020]

Press Statement: Trump Offers False Hope on Coronavirus Treatments (HRG Publication #2511)
At the White House press conference today, President Donald Trump continued to spew misleading, overly optimistic and often incoherent statements about potential treatments for the coronavirus that may be on the horizon.
[Created on 3/19/2020]

Letter to the Secretary of Labor Calling for OSHA to Establish an Emergency Temporary Standard to Protect Workers from the Novel Coronavirus (HRG Publication #2510)
Public Citizen, joined by 28 consumer advocacy, workers’ rights advocacy, science, research, and public health organizations, urged the Secretary of Labor to direct the Occupational Safety and Health Administration (OSHA) to immediately grant the American Federation of Labor and Congress of Industrial Organizations’ March 6, 2020, petition for an OSHA emergency temporary standard for infectious disease to address the rapidly expanding pandemic of the novel coronavirus disease, COVID-19.
[Created on 3/13/2020]

Press Statement: Larry Kudlow’s Untruthful Statement About the Rapidly Expanding Coronavirus Epidemic Endangers Public Health (HRG Publication #2509)
The last person who should be giving assessments and advice regarding the rapidly expanding novel coronavirus epidemic in the U.S. is ill-informed economic adviser Larry Kudlow, who is more interested in protecting President Donald Trump politically than protecting public health.
[Created on 3/6/2020]

Letter to the FDA Calling for Full Transparency Regarding Coronavirus-Related Drug Shortages (HRG Publication #2508)
On February 27, 2020, the Food and Drug Administration (FDA) announced the first known medication shortage linked to the COVID-19 outbreak that originated in China. The agency, however, has refused to disclose the name of the medication. Public Citizen urged the FDA to publicly identify the drugs that are involved in any shortage resulting from the COVID-19 epidemic.
[Created on 3/3/2020]

Letter to Pharmaceutical Industry Trade Groups Calling for Full Transparency Regarding Coronavirus-Related Drug Shortages (HRG Publication #2507)
Public Citizen urged the Pharmaceutical Research and Manufacturers of America, Association for Accessible Medicines, and Biotechnology Innovation Organization to encourage their member companies to publicly disclose the names of their specific drugs or biological products that are involved in any shortage resulting from the COVID-19 epidemic.
[Created on 3/3/2020]

Press Statement: White House’s Attempts to Muzzle Government Scientific Experts on Coronavirus Endanger Public Health (HRG Publication #2506)
There’s nothing wrong with a coordinated process inside the federal government to make sure it is sending out clear, fact-based information about the widening coronavirus epidemic. But there’s every reason to suspect something else is happening – that public health experts are being instructed to stay silent because they are sharing truthful information that the Trump administration finds inconvenient or that contradicts the random musings of the president.
[Created on 2/27/2020]

Press Statement: FDA Refuses to Ban Heart-Toxic Dietary Supplements Containing Cesium, Endangering Patients and Ignoring Agency’s Own Expert Assessment (HRG Publication #2505)
By denying our request to remove dietary supplements containing cesium chloride (or any other cesium salt) from the market, the Food and Drug Administration (FDA) has ignored its obligation to protect public health. It also has allowed consumers to continue to be exposed to life-threatening dietary supplements that have been promoted without basis to vulnerable cancer patients.
[Created on 2/5/2020]

Letter to the FDA Urging the Agency Not to Approve the New Drug Application for a Tramadol-Celecoxib Fixed-Dose Combination Product for Management of Acute Pain (HRG Publication #2504)
Public Citizen strongly urged the Food and Drug Administration (FDA) not to approve the new drug application submitted by Esteve Pharmaceuticals for a tramadol-celecoxib fixed-dose combination product for management of acute pain in adults because evidence from recent studies strongly counters the dangerously false assumption that tramadol, which was placed in schedule IV under the Controlled Substances Act in 2014, is safer; less likely to cause misuse, dependence, and addiction; and has a better safety profile than schedule II and schedule III opioids.
[Created on 1/31/2020]

Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding the Opioid Oxycodegol (HRG Publication #2503)
In testimony before a joint meeting of the Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committees to recommend that the FDA not approve the new opioid oxycodegol, which is closely related to oxycodone, for treatment of chronic low back pain because the medication is not effective for treating this condition but has oral abuse potential comparable to currently approved oxycodone products.
[Created on 1/14/2020]

2019

Letter to Congress Offering Health Care-Related Reforms for Possible Inclusion in Future Cures 2.0 Legislation (HRG Publication #2502)
Public Citizen wrote to Reps. Diana DeGette and Fred Upton in response to their solicitation of proposals for health care-related reforms to be considered for inclusion in potential future Cures 2.0 legislation. We urged them to include in any such legislation several proposals to improve patient safety and expand access to medicines by lowering prescription drug prices. Furthermore, it is imperative that any such legislation exclude expanded monopoly protections that keep prices higher for longer and inhibit access to medicines.
[Created on 12/16/2019]

Comments on the FDA’s Proposal to Amend the List of Bulk Drug Substances That Can be Used to Compound Drug Products Under Section 503A of the FDCA (HRG Publication #2501)
Regarding the Food and Drug Administration’s (FDA’s) proposal to add five bulk drug substances to the list of bulk drug substances that can be used to compound drug products under section 503A of the Food, Drug, and Cosmetic Act (FDCA), Public Citizen supports adding three of the bulk drug substances and opposes adding two. Public Citizen also strongly supports the FDA’s proposal to exclude 26 bulk drug substances from the list because of concerns regarding the substances’ safety or effectiveness.
[Created on 12/4/2019]

Testimony at OSHA’s Hearing on Its Proposed Changes to the Ancillary Provisions Regarding Occupational Beryllium Exposure in Construction and Shipyard Sectors (HRG Publication #2500)
In a testimony at the Occupational Safety and Health Administration’s (OHSA’s) informal public hearing on its proposal to revise the ancillary provisions regarding occupational beryllium exposure in construction and shipyard sectors, Public Citizen agreed with OSHA’s decision to rescind its June 2017 proposal to remove ancillary provisions in these sectors, but strongly urged OSHA to reconsider its current proposal to eliminate the requirements for personal protective equipment intended to ease the risk of dermal exposure in areas with beryllium exposures that potentially exceed trace amounts.
[Created on 12/3/2019]

Letter to the FDA Calling for Investigation Into an Apparent Illegal Clinical Trial That Tested Unapproved Naltrexone Implants in Prison Inmates (HRG Publication #2499)
Public Citizen and 31 doctors, bioethicists, prisoner advocates, and academics called on the Food and Drug Administration (FDA) to immediately investigate California-based BioCorRx, Inc. and the Louisiana Department of Public Safety and Corrections’ testing of an unapproved sustained-release naltrexone implant on prison inmates to determine its effectiveness in managing addiction disorders. Although the FDA has approved naltrexone in oral tablet and injectable forms to treat alcohol and opioid dependence, the agency has never approved any surgically implanted form of the drug.
[Created on 11/20/2019]

Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Using Empagliflozin to Treat Patients with Type 1 Diabetes (HRG Publication #2498)
In testimony before the Food and Drug Administration’s (FDA’s) Endocrinologic and Metabolic Drugs Advisory Committee, Public Citizen urged the FDA to reject Boehringer Ingelheim’s supplemental new drug application for empagliflozin for treatment of type 1 diabetes because the drug offers minimal benefits that do not outweigh the significantly increased risk of life-threatening diabetic ketoacidosis.
[Created on 11/13/2019]

Petition to the DEA and FDA to Reschedule the Opioid Tramadol From Schedule IV to Schedule II (HRG Publication #2497)
Public Citizen petitioned the Drug Enforcement Administration and Food and Drug Administration (FDA) to reschedule the opioid tramadol from the weakly controlled schedule IV under the Controlled Substances Act to the more tightly controlled schedule II because it is overprescribed, often misused, highly addictive and potentially deadly.
[Created on 11/6/2019]

Comments on the FDA’s Proposal to Exclude Nine Drugs From the 503B Bulks List for Pharmacy Compounding by Outsourced Facilities (HRG Publication #2496)
Public Citizen strongly supports the Food and Drug Administration’s (FDA’s) proposal to exclude nine bulk drug substances from the list of bulk drug substances for which there is a clinical need under Section 503B of the Federal Food, Drug, and Cosmetic Act for pharmacy compounding by outsourcing facilities. Each of the nominated bulk drug substances is a component of one or more FDA-approved drug products, and the nominators have failed to demonstrate that there is a clinical need for outsourcing facilities to compound drug products using the nominated bulk drug substances.
[Created on 11/4/2019]

Press Statement: Will FDA Pick Advance Trump’s Dangerous Deregulatory Agenda? (HRG Publication #2495)
Trump has a consistent record of nominating candidates to lead federal agencies who are chosen purely to support the administration’s dangerous deregulatory agenda, consequently undermining public health, harming consumers and destroying the planet. It is reasonable to assume that Dr. Hahn has assured Trump of his commitment to advancing such an agenda at the FDA.
[Created on 11/1/2019]

Testimony Before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee Regarding Hydroxyprogesterone Caproate (Makena) (HRG Publication #2494)
In a testimony before the Food and Drug Administration’s (FDA’s) Bone, Reproductive and Urologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA withdraw hydroxyprogesterone caproate (Makena) from the market because there is a lack of substantial evidence demonstrating that the drug is effective for preventing preterm birth or complications of preterm birth.
[Created on 10/29/2019]

Petition to the FDA to Ban the Drug Hydroxyprogesterone Caproate (Makena), Approved for Prevention of Preterm Birth (HRG Publication #2493)
Public Citizen petitioned the Food and Drug Administration (FDA) to immediately withdraw approval of the widely prescribed drug hydroxyprogesterone caproate (sold under the brand name Makena) and to place this drug on the list of drug products that may not be used in pharmacy compounding. These actions were requested because the results of a recently completed post-market clinical trial showed that it is not effective for preventing preterm birth prior to 35 weeks of pregnancy or major fetal and neonatal complications related to preterm birth.
[Created on 10/08/2019]

Testimony Before the FDA’s Pediatric Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Montelukast (HRG Publication #2492)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Pediatric Advisory Committee and Drug Safety and Risk Management Committee, Public Citizen urged the committees to recommend that the FDA strengthen warnings and alert healthcare providers about the use of montelukast for the treatment of asthma and the risk of neuropsychiatric events because this risk is inadequately communicated by healthcare providers/prescribers and patients remain unaware of the risk of these adverse events.
[Created on 9/27/2019]

Presentation at the FDA’s Public Hearing Entitled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction” (HRG Publication #2491)
In its presentation at the Food and Drug Administration’s (FDA’s) public hearing on opioids, Public Citizen emphasized that had the FDA acted with the urgency demanded by the ongoing opioid crisis and begun the important public process of developing a desperately needed improved opioid regulatory framework soon after it received the detailed, carefully considered National Academies of Sciences, Engineering, and Medicine’s recommendations two years ago, it is likely that the process of creating this framework would have been completed by now, rather than just beginning.
[Created on 9/17/2019]

Press Statement: FDA’s Double Denial Concerning Its Delinquency in Urgently Implementing Better Opioid Regulation (HRG Publication #2490)
The Food and Drug Administration’s (FDA’s) denial of our April 2019 petition for a temporary moratorium on new opioid approvals until the agency adopts a more rigorous regulatory framework for reviewing opioids that was recommended two years ago by the National Academies of Sciences, Engineering, and Medicine ironically also contains elaborate denials of the agency’s own dangerous lack of progress in adopting such an improved regulatory framework.
[Created on 9/9/2019]

Viewpoint Article Published in JAMA Internal Medicine: The Public Health Urgency of a Temporary FDA Moratorium on New Opioid Approvals (HRG Publication #2489)
In a viewpoint article published in JAMA Internal Medicine, Public Citizen’s Dr. Sidney Wolfe explains why the Food and Drug Administration (FDA) should immediately impose a moratorium on approval of all new drug applications for new opioids or new opioid formulation until the agency has implemented the elements recommended by the National Academies of Sciences, Engineering, and Medicine for inclusion in the currently nonexistent opioid regulatory framework.
[Created on 9/3/2019]

Comments on the FDA’s Proposal to Change the Approval Package Documentation Posted on the Agency’s Website For New Drugs and Biologics (HRG Publication #2488)
Public Citizen strongly objects to the Food and Drug Administration’s (FDA’s) proposal to use and publicly post, upon approval of a new drug applications or biologics license application, an abbreviated integrated review document in place of the more detailed individual medical, chemistry, pharmacology, statistical, clinical pharmacology biopharmaceutics, and risk assessment and risk mitigation reviews, among others, that have been prepared and regularly posted on the FDA website for many years.
[Created on 8/26/2019]

Comments on the FDA’s Draft Guidance for Industry Entitled “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework” (HRG Publication #2487)
Public Citizen finds the draft guidance overall to be woefully inadequate because its cursory content is far more focused on the nonspecific, generalized factors that the Food and Drug Administration (FDA) itself will consider when reviewing a new drug application (NDA) for an opioid, rather than providing industry with guidance as to what specific benefit and risk information should be sought out and included in future NDAs for new opioids.
[Created on 8/20/2019]

Letter to Congress Opposing Section 207 of S. 1895, the Lower Health Care Costs Act (HRG Publication #2486)
Public Citizen urged senators to oppose S. 1895, the Lower Health Care Costs Act, unless the legislation is amended to exclude section 207 because it would threaten patient safety by excluding biologic medicines from the requirement that all medicines marketed in the U.S. adhere to quality standards established by the United States Pharmacopeia.
[Created on 8/1/2019]

Press Statement: FDA’s Breast Implant Ban Is Too Little, Too Late for Many Women (HRG Publication #2485)
Why has the FDA recklessly and dangerously been treating women as second-class citizens? The kind of evidence now, belatedly, being cited as enough for a recall previously led to a ban of these implants in France in April, followed by bans in the rest of Europe and the U.K. Canada also banned these implants the first week in April.
[Created on 7/24/2019]

Letter to Congress Opposing Certain Provisions of S. 1895, the Lower Health Care Costs Act (HRG Publication #2484)
Public Citizen urged senators to oppose S. 1895, the Lower Health Care Costs Act, unless the legislation is amended to exclude sections 211 and 213 because they would weaken existing requirements for ensuring that generic drugs approved by the Food and Drug Administration (FDA) are safe and effective for their FDA-approved uses.
[Created on 7/18/2019]

Letters to Congress Calling for Investigation of HHS Failure to Report Its Medical Malpractice Payments to the NPDB (HRG Publication #2483)
Public Citizen urged U.S. Senate and House of Representatives committees that oversee the Department of Health and Human Services (HHS) to immediately probe the department’s decades-long failure to report nearly two-thirds of medical malpractice payments made on behalf of thousands of the agency’s own doctors and other health care professionals to the National Practitioner Data Bank (NPDB), as required by law and the department’s own policy. By not reporting these payments, the HHS has compromised patient safety and the integrity of the NPDB.
[Created on 7/16/2019]

Time to End Physician Sexual Abuse of Patients: Calling the U.S. Medical Community to Action (HRG Publication #2482)
A timely Perspective article published today by the Journal of General Internal Medicine sheds light on sexual abuse of patients at the hands of their physicians. The article describes evidence on the extent of this ethical problem and the factor that explain its persistence in the U.S. and recommends 11 keys steps that medical community, starting with medical boards, can take to better protect the public from physician sexual abuse.
[Created on 5/2/2019]

Letter to the OHRP Calling for a Halt to Unethical NIH-Funded Sepsis Clinical Trial Until NIH Stops Interfering in OHRP’s Evaluation of the Trial (HRG Publication #2481)
Public Citizen called on the Office for Human Research Protections (OHRP) to immediately cease its ethics-undermining subservience to the National Institutes of Health (NIH), invoke its authority under the U.S. Department of Health and Human Services human subjects protection regulations, and suspend the NIH-funded CLOVERS trial until the NIH allows two senior scientists at the NIH Clinical Center to speak to OHRP staff and the agency has completed its compliance oversight evaluation of the trial.
[Created on 5/1/2019]

Letter to the HHS Office of Inspector General Calling for an Investigation of NIH Leadership’s Obstruction of OHRP Probe of Unethical, Reckless Sepsis Clinical Trial (HRG Publication #2480)
Public Citizen called on the Department of Health and Human Services (HHS) Inspector General to immediately investigate the actions taken by senior National Institutes of Health (NIH) officials, including the agency’s Principal Deputy Director, to muzzle the agency’s own scientific experts, thereby effectively interfering with the HHS Office for Human Research Protections’ (OHRP’s) compliance oversight evaluation of ethical and regulatory lapses involving a major ongoing NIH-funded sepsis clinical trial.
[Created on 4/29/2019]

Press Statement: FDA Bans Dangerous Surgical Mesh for Pelvic Repair, Following Public Citizen Urging (HRG Publication #2479)
Although Public Citizen welcomes this long-overdue action, this ban comes too late for the thousands of women who have been irreparably harmed by these devices, long after the FDA knew the devices had “not demonstrated a reasonable assurance of safety.”
[Created on 4/16/2019]

Petition to the FDA to Require a Black-Box Warning for the Osteoporosis Drug Prolia (HRG Publication #2478)
Public Citizen petitioned the Food and Drug Administration (FDA) to add a black-box warning to the product labeling for the osteoporosis drug, Prolia (denosumab), to alert doctors and patients about the risk of vertebral fractures associated with cessation of the drug and need for alternative osteoporosis treatment after stopping the drug.
[Created on 4/16/2019]

Letter to the FDA Urging the Agency Not to Approve the De Novo Premarket Application for neuroAD Therapy System for the Treatment of Alzheimer’s Dementia (HRG Publication #2477)
Public Citizen urged the Food and Drug Administration (FDA) not to approve the do novo premarket application for the neuroAD Therapy System from Neuronix as an adjunctive treatment of mild-to-moderate Alzheimer’s Dementia because the data from the clinical trials demonstrated that the device does not offer any clinically meaningful benefits.
[Created on 4/9/2019]

Press Release: Responses of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group, to Gottlieb Testimony on Opioids (HRG Publication #2476)
Scott Gottlieb, Food and Drug Administration (FDA) commissioner, today testified about opioids at a hearing of the U.S. Senate Appropriations Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. His testimony included several misleading statements and omissions.
[Created on 3/28/2019]

Testimony Before the FDA’s General and Plastic Surgery Devices Panel Regarding Breast Implants (HRG Publication #2475)
In testimony before the Food and Drug Administration’s (FDA’s) General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee, Public Citizen highlighted the serious health problems linked to breast implants and the inadequate regulation of these and other permanently implanted medical devices over the past several decades. The history of breast implants reminds us why much more extensive mandatory pre-approval testing of permanently implanted devices, like breast implants, is necessary; otherwise, patients are serving as unwitting guinea pigs.
[Created on 3/26/2019]

Petition to the FDA for a Moratorium on Approval of New Opioids or New Opioid Formulations (HRG Publication #2474)
Public Citizen petitioned the Food and Drug Administration (FDA) to immediately impose a moratorium on approval of all new drug applications for new opioids or new opioid formulations, not to be lifted until the FDA has implemented the elements recommended by the National Academies of Sciences, Engineering, and Medicine for inclusion in a currently non-existent opioid regulatory framework that is intended to prevent a continuation of dangerous past regulatory errors that clearly have contributed to the current deadly opioid crisis in the U.S.
[Created on 3/21/2019]

Letter to the FDA Urging the Agency Not to Approve the New Drug Application for Sotagliflozin for Treating Type 1 Diabetes (HRG Publication #2473)
Public Citizen strongly urged the Food and Drug Administration (FDA) not to approve the new drug application (NDA) for sotagliflozin (ZYNQUISTA) for use as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes because the data from the phase 3 clinical trials presented in the NDA show that the drug causes an unacceptable eight-fold increased risk of life-threatening diabetic ketoacidosis in subjects with type 1 diabetes given the drug, compared with those given a placebo.
[Created on 3/11/2019]

Press Statement: Good Riddance to FDA Commissioner Scott Gottlieb (HRG Publication #2472)
Scott Gottlieb was entangled in an unprecedented web of Big Pharma ties when he was nominated in 2017 to be FDA commissioner. Not surprisingly, his tenure as commissioner was marked by regulatory decision making regarding medications and medical devices that tilted further in favor of industry’s financial interests rather than the interests of public health.
[Created on 3/5/2019]

Letter to the FDA Urging the Agency Not to Approve the New Drug Application for Esketamine for the Treatment of Treatment-Resistant Depression (HRG Publication #2471)
Public Citizen strongly urged the Food and Drug Administration (FDA) not to approve the new drug application (NDA) for the drug-device combination of esketamine (SPRAVATO) for intranasal administration for the treatment of treatment-resistant depression because the data from the clinical trials presented in the NDA failed to provide substantial evidence that the drug is effective for its proposed indication for use and there is clear evidence that the drug has serious risks of harm.
[Created on 2/27/2019]

Letter to the Maryland Senate’s Education, Health, and Environmental Affairs Committee Opposing a Bill That Would Shield Bad Doctors Who Engaged in Serious Misconduct (HRG Publication #2470)
Public Citizen strongly urged Maryland Senate’s Education, Health, and Environmental Affairs Committee to soundly reject Senate Bill 372 because it would (a) seriously compromise patient access to nearly half of the information about important disciplinary actions taken by the Maryland Board of Physicians against physicians who may have been found to have engaged in serious misconduct, (b) make it more difficult for the Board to investigate and discipline physicians under certain circumstances, and (c) ultimately, undermine patient safety protections in Maryland.
[Created on 2/22/2019]

Comments on the FDA’s Proposed Rule for Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (HRG Publication #2469)
Public Citizen is deeply concerned that once the Food and Drug (FDA) finalizes the proposed rule, clinical investigators inappropriately will seek, and IRBs inappropriately will grant, waivers of informed consent for clinical investigations that involve greater than minimal risk to the subjects.
[Created on 2/13/2019]

Testimony Before the FDA’s Obstetrics and Gynecology Devices Panel Regarding Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (HRG Publication #2468)
In testimony before the Food and Drug Administration’s (FDA’s) Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee, Public Citizen urged the FDA to reject the premarket approval applications for the three mesh products for transvaginal repair of pelvic organ prolapse (POP) that are still on the market because these devices offer no clinically significant benefits in comparison with non-mesh repair of POP and have high rates of serious complications. Surgical mesh for transvaginal POP repair is a quintessential example of the fundamental deficiencies in the FDA’s oversight of medical devices, particularly those that are permanently implanted.
[Created on 2/12/2019]

Press Release: Arizona Nurse Arrested for Assault on Incapacitated Patient Highlights How Few Nurses Face Punishment for Abuse (HRG Publication #2467)
The arrest of a male nurse for the sexual assault of an incapacitated female patient in Arizona underscores what Public Citizen found in a groundbreaking study last month: State nursing boards are failing to protect patients from nurses who engage in sexual misconduct.
[Created on 1/23/2019]

Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Sotagliflozin (HRG Publication #2466)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Endocrinologic and Metabolic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Sanofi’s new drug application for sotagliflozin for treatment of type 1 diabetes because the drug offers minimal benefits that do not outweigh the significantly increased risk of life-threatening diabetic ketoacidosis.
[Created on 1/17/2019]

Testimony Before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee Regarding Romosozumab (HRG Publication #2465)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Bone, Reproductive and Urologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Amgen’s new drug application for romosozumab for treatment of osteoporosis in postmenopausal women at high risk for fracture because of clinical trial data linking the drug to an increased risk of serious adverse cardiovascular events.
[Created on 1/16/2019]

Testimony Before the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Febuxostat (HRG Publication #2464)
In testimony before a joint meeting of the Food and Drug Administration’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committees to recommend that the FDA immediately remove from the market the widely used gout medication febuxostat because it poses unique, serious risks – include the risk of dying from cardiovascular disease – but offers no unique benefit. Public Citizen had requested such action in a citizen petition submitted to the agency on June 21, 2018.
[Created on 1/11/2019]

2018

Crossing the Line: Sexual Misconduct by Nurses Reported to the National Practitioner Data Bank (HRG Publication #2463)
A groundbreaking study published by Public Citizen in the journal Public Health Nursing showed that state nursing boards are failing to protect patients from nurses who engage in sexual misconduct. According to the study, only 882 U.S. registered licensed practical or vocational nurses have been reported to the National Practitioner Data Bank over 14 years (from 2003 through 2016) because of such misconduct.
[Created on 12/17/2018]

Press Statement: FDA Rule Withdrawal Fails to Modernize Generic Labeling and Endangers Patient Safety (HRG Publication #2462)
The FDA’s withdrawal of its proposed rule that would have allowed generic drug makers to immediately update safety labels to describe new risks to consumers without prior agency approval represents a flagrant disregard for public health and common sense because it continues to immunize generic manufacturers from any liability if patients are injured or killed by a generic medication, even when warnings about serious risks known to the companies are missing from the labels.
[Created on 12/13/2018]

Letter to the FDA Commissioner Refuting Claims Made in His Public Statement Justifying the Approval of Sufentanil Sublingual Tablets (Dsuvia) (HRG Publication #2461)
In a letter to Dr. Scott Gottlieb, the Food and Drug Administration (FDA) Commissioner, Public Citizen and the chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee explain how the Commissioner misled the public regarding potential “unique” benefits of Dsuvia, a controversial, highly potent opioid pain relief medication.
[Created on 12/11/2018]

Comments on the FDA’s Revised Draft Guidance on Insanitary Conditions at Compounding Facilities (HRG Publication #2460)
Public Citizen, in general, supports the Food and Drug Administration’s (FDA’s) draft guidance for industry “Insanitary Conditions at Compounding Facilities (Revision 1).” The numerous detailed examples of insanitary conditions provided in the draft guidance should assist compounding facilities in identifying and remediating insanitary conditions. However, Public Citizen strongly objects to the FDA’s addition of a statement indicating that for physician compounding or repackaging of drug products, the agency does not intend to enforce legal requirements that prohibit the preparation, packing, and holding of drugs under insanitary conditions.
[Created on 11/26/2018]

Op-Ed in The Washington Post Regarding the FDA’s Approval of Sufentanil Sublingual Tablets: The FDA Made the Wrong Call on This Powerful, New Opioid (HRG Publication #2459)
In a joint op-ed, Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, and Dr. Raeford Brown, chair of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee, are highly critical of the FDA’s reckless decision to approve sufentanil sublingual tablets, a new opioid that will be sold under the brand name Dsuvia.
[Created on 11/16/2018]

Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding a Purportedly Abuse-Deterrent, Immediate-Release Form of Oxycodone (HRG Publication #2458)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject new drug application submitted by SpecGx for an immediate-release oral tablet formulation of oxycodone that is intended to be abuse-deterrent for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
[Created on 11/14/2018]

Letter to the Florida Attorney General Regarding Utopia Wellness’s Dissemination of False Advertisements Promoting Cesium Chloride for Treatment of Cancer (HRG Publication #2457)
Public Citizen sent a letter to the Florida Attorney General requesting an investigation of the use of falsified scientific citations in the advertisement and promotion of an illegal heart-toxic drug for treatment of cancer by Utopia Wellness, a Florida-based medical center. The medical’s website materials misleadingly claim that cesium chloride is safe and effective for treating cancer but offers no evidence from well-controlled clinical tests to support its claims.
[Created on 11/7/2018]

Letter to the Director of Medicine at Utopia Wellness Regarding Its Promotion of Cesium Chloride for Treatment of Cancer (HRG Publication #2456)
Public Citizen sent a letter to Dr. Carlos M. Garcia, the Director of Medicine at Utopia Wellness, informing him that Public Citizen had submitted complaint letters to the Federal Trade Commission, Food and Drug Administration, and Florida Board of Medicine regarding his medical center’s dissemination of false and misleading advertisements that promote the use of cesium chloride.
[Created on 11/5/2018]

Press Release: FDA Makes Wrong Call; Super-Strong Opioid Medication Will Be Abused and Kill People (HRG Publication #2455)
The Food and Drug Administration (FDA) is recklessly and needlessly endangering people by approving a super-strong opioid, Public Citizen and the head of a key FDA advisory committee said today. The FDA gave the green light for the medication, which is called sufentanil sublingual tablet (brand name Dsuvia) and is to be used to treat moderate-to-severe acute pain in a medically supervised setting. It is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine.
[Created on 11/2/2018]

Comments on the FDA’s Proposal to Exclude Bumetanide, Nicardipine Hydrochloride, and Vasopressin from the 503B Bulks List for Pharmacy Compounding by Outsourcing Facilities (HRG Publication #2454)
Public Citizen strongly supports the Food and Drug Administration’s (FDA’s) proposal to exclude bumetanide, nicardipine hydrochloride, and vasopressin from the list of bulk drug substances for which there is a clinical need under Section 503B of the Federal Food, Drug, and Cosmetic Act for pharmacy compounding by outsourcing facilities. Each of the nominated bulk drug substances is a component of one or more FDA-approved drug products, and the nominators have failed to demonstrate that there is a clinical need for outsourcing facilities to compound drug products using the nominated bulk drug substances.
[Created on 10/29/2018]

Second Follow-up Letter to the FDA and OHRP Regarding Unethical High-Risk Clinical Trials That Tested Ketamine for Management of Agitation (HRG Publication #2453)
Public Citizen, joined by two bioethicists from the University of Minnesota, wrote to the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) to highlight key observations made by FDA inspectors during an inspection of the Hennepin County Medical Center’s (HCMC’s) institutional review board from August 7 to August 23, 2018. The inspection confirmed that HCMC violated federal regulations when it conducted high-risk clinical trials that involved testing the safety and effectiveness of the ketamine compared with other potent sedative drugs for management of pre-hospital agitation without the informed consent of the subjects.
[Created on 10/29/2018]

Letter to the Florida Board of Medicine Regarding the Director of Medicine at Utopia Wellness, Which Promotes and Uses Cesium Chloride for Treatment of Cancer (HRG Publication #2452)
Public Citizen sent a letter to the Florida Board of Medicine requesting an investigation into the medical practice of Dr. Carlos Garcia, M.D., the Director of Medicine at Utopia Wellness. We specifically requested that the board investigate (1) Dr. Garcia’s role in Utopia Wellness’s dissemination of false and misleading advertisements that promote the use of compounded intravenous (IV) cesium chloride as a treatment for cancer and (2) whether Dr. Garcia and his staff have continued to treat cancer patients with compounded IV cesium chloride since late July 2018, when the Food and Drug Administration took action that prohibited pharmacy compounding using bulk cesium chloride.
[Created on 10/23/2018]

Letter to the FDA Urging the Agency Not to Approve the New Drug Application for Sufentanil Sublingual Tablets, a Super-Potent Opioid (HRG Publication #2451)
In a letter to the Food and Drug Administration (FDA), the chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee joined three Public Citizen experts in urging the agency to reject Acer Pharmaceuticals’ new drug application for sufentanil sublingual tablets for treatment of moderate-to-severe acute pain in a medically supervised setting. This opioid, which is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine, would be abused and start killing people as soon as it hits the market.
[Created on 10/18/2018]

Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee Regarding Sublingual Sufentanil Tablets (HRG Publication #2450)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject new drug application submitted by AcelRx Pharmaceuticals for sufentanil sublingual tablets because the drug is a dangerous, high potency opioid that does not provide any unique advantages over currently available opioids, but does pose unique risks.
[Created on 10/12/2018]

Letter to the FDA Regarding Utopia Wellness’s Promotion and Use of Cesium Chloride for Treatment of Cancer (HRG Publication #2449)
Public Citizen sent a letter to the Food and Drug Administration (FDA) requesting an investigation of the promotion and use of an illegal cesium chloride drug for treatment of cancer by Utopia Wellness, a Florida-based medical center. Under current FDA policies governing pharmacy compounding, no State-licensed pharmacy or licensed physician affiliated with Utopia Wellness currently may legally compound cesium chloride.
[Created on 10/9/2018]

Letter to the FTC Regarding Utopia Wellness’s Dissemination of False Advertisements Promoting Cesium Chloride for Treatment of Cancer (HRG Publication #2448)
Public Citizen sent a letter to the Federal Trade Commission (FTC) requesting an investigation of the use of falsified scientific citations in the advertisement and promotion of an illegal heart-toxic drug for treatment of cancer by Utopia Wellness, a Florida-based medical center. The medical’s website materials misleadingly claim that cesium chloride is safe and effective for treating cancer but offers no evidence from well-controlled clinical tests to support its claims.
[Created on 10/9/2018]

Letter to the Vanderbilt University Medical Center IRB Chairs Regarding Sepsis Clinical Trial Funded by NIH (HRG Publication #2447)
Public Citizen called on the Vanderbilt University Medical Center institutional review board (IRB) that approved the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis trial (CLOVERS) to (a) immediately review our letter to the Office for Human Research Protections in which we identified serious ethical and regulatory lapses related to the design and sample consent form of CLOVERS and (b) suspend the IRB’s approval of CLOVERS and direct the CLOVERS investigators to cease enrolling subjects in the trial.
[Created on 8/29/2018]

Letter to OHRP Calling for a Halt to Unethical, Reckless Sepsis Clinical Trial Funded by NIH (HRG Publication #2446)
Public Citizen called on the Office for Human Research Protections (OHRP) to immediately direct the National Heart, Lung, and Blood Institute to terminate enrollment in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis trial (CLOVERS) and launch a compliance oversight investigation of the trial. The design of CLOVERS is deeply flawed and exposes subjects to unacceptable dangers, included increased risks of organ failure and death.
[Created on 8/28/2018]

Comments on the FDA’s Draft Guidance on the Assessment of Pressor Effects of Drugs (HRG Publication #2445)
Public Citizen, joined by two academic physicians, urged the Food and Drug Administration (FDA) to revised its draft guidance on the assessment of pressor effects of drugs to specify, among other things, the following: (a) a time interval that distinguishes short-term drug use from long-term use; (b) what constitutes a large blood pressure increase for drugs intended for short-term use; and (c) for drugs intended for long-term use, a requirement for premarket cardiovascular safety data for drugs that raise SBP more than 2 mm Hg or that raise DBP more than 1 mm Hg compared with a placebo.
[Created on 7/30/2018]

Follow-up Letter to the FDA and OHRP Regarding Unethical High-Risk Clinical Trials That Tested Ketamine for Management of Agitation (HRG Publication #2444)
Public Citizen wrote to the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) to bring to their attention the July 26, 2018, report, MPD Involvement in Pre-Hospital Sedation, which was issued by the Office of Police Conduct Review in Minneapolis. The report contains new information pertinent to two prospective clinical trials that involved testing the dangerous general anesthetic ketamine and powerful sedatives on agitated patients without their consent.
[Created on 7/30/2018]

Letter to the Association for the Accreditation of Human Research Protection Programs Regarding the Hennepin County Medical Center’s Human Subjects Protection (HRG Publication #2443)
Public Citizen requests that the Association for the Accreditation of Human Research Protection Programs immediately rescind its no longer justifiable accreditation of the human subjects protection program at the Minneapolis Medical Research Foundation and the Hennepin County Medical Center. Such action is need because of unacceptable regulatory and ethical lapses in the oversight and conduct of the two prospective clinical trials that involved testing the safety and effectiveness of the general anesthetic ketamine compared with those of other potent sedative drugs for management of prehospital agitation.
[Created on 7/26/2018]

Letter to the FDA and OHRP Calling for Investigations of Unethical High-Risk Clinical Trials That Tested Ketamine for Management of Agitation (HRG Publication #2442)
Public Citizen and 64 doctors, bioethicists, and academics called on the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) to immediately investigate two prospective clinical trials that involved testing the dangerous general anesthetic ketamine and powerful sedatives on agitated patients without their consent. Disturbingly, these experiments were incorrectly determined by the researchers and the Hennepin County Medical Center’s institutional review board (IRB) to involve no more than minimal risk to the subjects and, based on that determination, the IRB waived the informed consent requirements.
[Created on 7/25/2018]

Press Statement: FDA Agrees With Public Citizen, Responds to Petition by Taking Action to Prohibit Pharmacy Compounding of Cesium Chloride (HRG Publication #2441)
Although Public Citizen supports the Food and Drug Administration’s (FDA’s) belated action to block pharmacy compounding of cesium chloride, the agency should have acted more than two years ago when its own reviewers concluded that cesium chloride is “not safe for human use” and “has not been shown to be efficacious for the prevention or treatment of any form of cancer.”
[Created on 7/23/2018]

Petition to the FDA to Ban All Cesium Dietary Supplements (HRG Publication #2440)
Public Citizen petitioned the Food and Drug Administration (FDA) to ban the sale of all dietary supplements containing the chemical cesium chloride or any other cesium salt because they present a significant and unreasonable risk of illness or injury. Cesium can cause serious, life-threatening adverse cardiovascular events, and the FDA has declared cesium chloride to be unsafe for human use. These products have been promoted as treatments for cancer, despite the lack of evidence demonstrating cesium’s proposed cancer-treating properties.
[Created on 7/23/2018]

Petition to OSHA to Implement a Federal Standard to Protect Workers from Occupational Exposure to Excessive Heat (HRG Publication #2439)
Public Citizen, Farmworker Justice, United Farm Workers, two former Occupational Safety and Health Administration (OSHA) administrators, a former California-OSHA director, and 131 other organizations petitioned OSHA to initiate a rulemaking process to establish the first federal standards protecting workers from the dangers of heat stress. As climate change results in more frequent days of extreme heat and record-breaking summers become the norm, outdoor and indoor workers in workplaces including farms, construction sites, steel mills, warehouses, meat-packing plants, and vehicles will be at greater risk for workplace heat stress.
[Created on 7/17/2018]

Testimony Before the HHS Secretary’s Advisory Committee on Human Research Protections Regarding the July 2017 HHS Office of Inspector General Report on OHRP’s Compliance Activities (HRG Publication #2438)
In testimony before the Department of Health and Human Services (HHS) Secretary’s Advisory Committee on Human Research Protections, Public Citizen stated that the July 2017 HHS Office of Inspector General (OIG) report assessing the Office for Human Research Protections’ (OHRP’s) compliance activities revealed that OHRP’s enforcement of regulations for the protection of human subjects has literally become moribund. The OIG report demonstrated that OHRP is abusing its discretion when deciding whether to initiate formal for-cause compliance evaluations of substantive written allegations.
[Created on 7/10/2018]

Follow-up Complaint Letter to the OHRP and the VA Office of Research Oversight Regarding a Potentially Unethical Clinical Trial Involving Heart Attack Patients (HRG Publication #2437)
Public Citizen called on the Office for Human Research Protections (OHRP) and the Department of Veterans Affairs (VA) Office of Research Oversight to take additional actions to address serious noncompliance with federal regulations for the protection of human subjects related to the conduct of the National Institutes of Health-funded Myocardial Ischemia and Transfusion Trial.
[Created on 7/5/2018]

Public Citizen Urges OSHA Not To Delay Important Beryllium Protections For General Industry Workers (HRG Publication #2436)
Public Citizen submitted comments strongly urging the Occupational Safety and Health Administration (OSHA) not to finalize a proposed rule that would delay for at least several months the compliance date for certain ancillary requirements of the general industry beryllium standard. Such delays would unnecessarily ensure the occurrence of even more cases of beryllium sensitization, chronic beryllium disease, and lung cancer among general industry workers exposed to beryllium.
[Created on 6/29/2018]

Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Extended Release Oxycodone (HRG Publication #2435)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject new drug application submitted by Pain Therapeutics for oxycodone extended-release capsules for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
[Created on 6/26/2018]

Petition to the FDA to Ban the Gout Medication Febuxostat (Uloric) (HRG Publication #2434)
Public Citizen petitioned the Food and Drug Administration (FDA) to ban the sale of the widely prescribed gout drug febuxostat (sold under the brand name Uloric) because use of the drug increases the risk of death compared with alternative therapies and there exist other effective medications that have been approved by the FDA for treatment of gout that have a lower risk of death.
[Created on 6/21/2018]

Press Statement: Public Citizen Supports NIH Advisory Panel’s Recommendation to Terminate Ongoing Alcohol Health Study Being Funded by Industry (HRG Publication #2433)
Public Citizen strongly supports the NIH advisory committee’s recommendation to terminate the NIAAA-sponsored alcohol study because the industry funding – and the manner in which that funding was solicited – already had irreparably undermined public trust in the design and integrity of the study.
[Created on 6/15/2018]

Press Release: Public Citizen Complaint Prompts Changes to Potentially Unethical Clinical Trial Involving Heart Attack Patients (HRG Publication #2432)
Substantive changes have been made to the protocol and consent forms for the NIH-funded Myocardial Ischemia and Transfusion (MINT) trial in response to a complaint filed by Public Citizen over potentially serious ethical violations, the Department of Health and Human Services’ Office for Human Research Protections and the Department of Veterans Affairs’ Office of Research Oversight said in a letter delivered to Public Citizen.
[Created on 6/12/2018]

Comments on the FDA’s Draft Guidance Regarding Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act (HRG Publication #2431)
In general, Public Citizen strongly supports the policies proposed in the draft guidance document. In particular, the proposed guidance seeks to appropriately limit, under section 503B, the use of bulk drug substances by outsourcing facilities in pharmacy compounding of human drug products that are not on the FDA’s drug shortage list.
[Created on 5/25/2018]

Press Statement: FDA Agrees With Public Citizen, Responds to Petition by Telling Companies to Stop Marketing Over-the-Counter Benzocaine Teething Products (HRG Publication #2430)
The Food and Drug Administration (FDA) agreed with Public Citizen that over-the-counter oral health care products containing benzocaine should never be used in infants under any circumstances, even with the advice and supervision of a health care professional, because of the risk of methemoglobinemia, a life-threatening blood disorder that impairs the body’s ability to use oxygen.
[Created on 5/25/2018]

Press Statement: FDA’s Action to Protect Infants From Serious Blood Disorder Caused by Over-the-Counter Benzocaine Teething Products Is Long Overdue (HRG Publication #2429)
The FDA’s action today to protect infants and children from exposure to over-the-counter oral health products containing benzocaine, which can cause methemoglobinemia, a life-threatening blood disorder that impairs the body’s ability to use oxygen, comes too late for some infants and children.
[Created on 5/23/2018]

Press Statement: By Approving the Senate’s Version of the False Hope Act, House Lawmakers Open a More Dangerous Pathway for Experimental Medications (HRG Publication #2428)
The House of Representatives’ passage of S. 204, the Senate’s seriously flawed False Hope legislation, opens the gate to a dangerous, uncharted pathway for accessing experimental medications that have not been shown to be safe or effective. The bill passed today will expose vulnerable patients to risks of serious harm, including dying earlier and more painfully than they otherwise would have, without appropriate safeguards.
[Created on 5/22/2018]

Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Buprenorphine Sublingual Spray (HRG Publication #2427)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject INSYS Development Company’s new drug application for buprenorphine sublingual spray for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate because the risks of the drug outweigh the benefits.
[Created on 5/22/2018]

Letter to the U.S. House of Representatives Opposing Passage of the Senate’s “False Hope” Legislation (HRG Publication #2426)
Public Citizen urged members of the U.S. House of Representatives to oppose S. 204, the version of “False Hope” legislation that was passed by the Senate in August 2017. Importantly, although H.R. 5247 — the House of Representatives-passed version of this legislation — has significant flaws that would endanger patients, it nevertheless would provide substantially stronger safeguards for patients who would receive investigational drugs under the Right-to-Try pathway than those provided by S. 204.
[Created on 5/21/2018]

Statement by Dr. Sidney Wolfe at Press Conference Regarding Sweeping Pharmaceutical Reform Proposal Published in the British Medical Journal (HRG Publication #2425)
At a press conference unveiling a comprehensive proposal to ensure universal access to safe, innovative, and affordable medications that was published in the British Medical Journal, Dr. Sidney Wolfe highlighted three situations related to the pharmaceutical system that undermine public health.
[Created on 5/17/2018]

Press Statement: Public Citizen Applauds HHS Inspector General Review of Conduct of NIH Officials Who Sought Alcohol Industry Funding for Alcohol Health Study (HRG Publication #2424)
Public Citizen applauds the decision by the U.S. Department of Health and Human Services Office of Inspector General to look into the serious allegations that National Institutes of Health officials orchestrated a campaign to obtain funding from alcoholic beverage manufacturers to fund a $100 million National Institute on Alcohol Abuse and Alcoholism study that is intended to assess the cardiovascular health effects of moderate alcohol consumption.
[Created on 5/9/2018]

Editorial in the Journal of General Internal Medicine Regarding Hospital Profit Margins (HRG Publication #2423)
U.S. hospitals, most of which are nonprofit, are mired in a toxic cycle that rewards bad behavior from their leaders, neglects patient needs and promotes an obsession with increasing profits, according to an editorial by Public Citizen Health Research Group founder and senior adviser, Dr. Sidney Wolfe, and colleagues Drs. Steffie Woolhandler and David Himmelstein at the City University of New York at Hunter College, published in the Journal of General Internal Medicine. The editorial is in response to an article by researchers Dan Ly and David Cutler, who examined how successful hospitals improved operating margins and patient care.
[Created on 5/1/2018]

Letter to the DEA Requesting an Investigation of White House Physician Dr. Ronny L. Jackson (HRG Publication #2422)
Public Citizen called on the Drug Enforcement Administration (DEA) to launch a formal investigation into the conduct of Dr. Ronny Lynn Jackson who, according to recent media reports, has a history of “casually dispensing Ambien for sleep and Provigil for arousal, both of which are dangerous controlled substances with a potential for addiction.” If true, such conduct would be “illegal” according to a spokesperson for the DEA and would warrant immediate revocation of Dr. Jackson’s DEA registration.
[Created on 4/30/2018]

Letter to the Virginia Board of Medicine Requesting an Investigation of White House Physician Dr. Ronny L. Jackson (HRG Publication #2421)
Public Citizen called on the Virginia Board of Medicine to launch a formal investigation into the medical practice of Dr. Ronny Lynn Jackson who, according to recent media reports, has a history of “casually dispensing Ambien for sleep and Provigil for arousal, both of which are dangerous controlled substances with a potential for addiction.” If true, such conduct would represent unethical and dangerous medical practice and warrant immediate revocation of Dr. Jackson’s Virginia medical license.
[Created on 4/27/2018]

Testimony Before the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Celecoxib (HRG Publication #2420)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen argued that because of the major limitations of the PRECISION trial, no meaningful conclusions can be drawn from the trial regarding the cardiovascular safety of celecoxib relative to ibuprofen and naproxen.
[Created on 4/25/2018]

Research Group Study Examines Use of Placebos in Clinical Trials Testing New Drugs for Life-Threatening Diseases (HRG Publication #2419)
Published in Open Access Journal of Clinical Trials, our study found that the use of placebos in clinical trials testing new drugs for life-threatening diseases for which treatments proven to be effective are already available is widespread and can put human subjects at increased risk of harm.
[Created on 4/24/2018]

Testimony Before the FDA’s Arthritis Advisory Committee Regarding Baricitinib (HRG Publication #2418)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Eli Lilly and Company’s new drug application for baricitinib for treatment of rheumatoid arthritis because it lacks any unique benefit over the very similar FDA-approved drug tofacitinib but causes unique life-threatening harms.
[Created on 4/23/2018]

Letter to HHS Secretary Calling for an Independent Investigation of NIH Officials Who Sought Alcohol Industry Funding for Alcohol Health Study (HRG Publication #2417)
Public Citizen and 13 other groups sent a letter to the U.S. Department of Health and Human Services (HHS) Secretary urging him to request that the HHS Inspector General launch an investigation into the conduct of National Institutes of Health (NIH) officials who allegedly were involved in soliciting donations from alcoholic beverage companies to fund a major study that is intended to assess the health effects of moderate alcohol consumption.
[Created on 4/11/2018]

Letter to Louisiana State Legislature Opposing a Bill That Would Weaken the Louisiana State Board of Medical Examiners (HRG Publication #2416)
Public Citizen calls on the Louisiana State Legislature to reject Senate Bill No. 286 because it would seriously compromise patient safety in Louisiana. In particular, multiple provisions of the proposed legislation would substantially impede the Louisiana State Board of Medical Examiners’ ability to appropriately investigate allegations of physician incompetence or unprofessional conduct and thereby to protect the public from dangerous doctors.
[Created on 4/10/2018]

Press Statement: Director of National Institute on Alcohol Abuse and Alcoholism Must Be Removed (HRG Publication #2415)
In light of the disturbing revelations that National Institute on Alcohol Abuse and Alcoholism Director Dr. George Koob has been doing the bidding of the alcohol industry, National Institutes of Health Director Dr. Frances Collins should immediately demand his resignation or fire him.
[Created on 4/5/2018]

Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee Regarding Lofexidine (HRG Publication #2414)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Psychopharmacologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject WorldMeds’s new drug application for lofexidine for the symptomatic treatment of opioid withdrawal because the maximum dose for which approval is being sought is significantly more dangerous but no more effective than lower doses used in the UK.
[Created on 3/27/2018]

Letter to the Editor of The Washington Post Criticizing NIH Director’s Plan for Internal Probe of Its Own Alcohol Study (HRG Publication #2413)
In a letter to the editor of The Washington Post, Public Citizen attacked National Institutes of Health (NIH) Director Francis Collins’s plan for an internal investigation into allegations that senior NIH officials orchestrated a concerted campaign to obtain funding from the alcoholic beverage industry for a $100 million study of the health effects of moderate alcohol consumption.
[Created on 3/25/2018]

Follow-up Letter to the HHS Office of Inspector General Regarding the Need for an Independent Investigation Into NIH’s Solicitation of Donations From the Alcoholic Beverage Industry for Alcohol Research Study (HRG Publication #2412)
In response to an announcement by the National Institutes of Health (NIH) director that he had initiated an internal investigation into the conduct of NIH officials who allegedly were involved in soliciting donations from alcoholic beverage companies to fund a major study on the health effects of moderate alcohol consumption, Public Citizen urged the Department of Health and Human Services (HHS) Inspector General not to allow this announcement to dissuade him from opening the type of independent Inspector General’s investigation that these circumstances demand.
[Created on 3/22/2018]

Press Statement: By Approving the False Hope Act, House Lawmakers Create Dangerous Pathway for Experimental Medications (HRG Publication #2411)
The House’s passage of the seriously flawed False Hope legislation takes us one step closer to the creation of a dangerous, uncharted pathway for accessing experimental medications that have not been shown to be safe or effective.
[Created on 3/21/2018]

Letter to the HHS Office of Inspector General Requesting an Investigation Into NIH’s Solicitation of Donations From the Alcoholic Beverage Industry for Alcohol Research Study (HRG Publication #2410)
Public Citizen called on the Department of Health and Human Services (HHS) Inspector General to immediately launch a formal investigation into the conduct of National Institutes of Health (NIH) officials who allegedly were involved in soliciting donations from alcoholic beverage companies to fund a major study that is intended to assess the health effects of moderate alcohol consumption.
[Created on 3/19/2018]

AHCJ Blog Post: New Report on Big Pharma Settlements Highlights Need for Tougher Enforcement (HRG Publication #2409)
In an invited commentary for the Association of Health Care Journalists’ (AHCJ’s) Sunshine Week, Dr. Michael Carome, director of Public Citizen’s Health Research Group, discuss Public Citizen’s updated report cataloging all major financial settlements that the pharmaceutical industry has been forced to sign with federal and state governments from 1991 through 2017 for illegal activities.
[Created on 3/14/2018]

Twenty-Seven Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2017 (HRG Publication #2408)
Public Citizen published a report that catalogues all major financial settlements and court judgments between pharmaceutical companies and federal and state governments from 1991 through 2017. The report found that drugmakers entered into 412 settlements totaling $38.6 billion in criminal and civil penalties, but that the number and size of federal and state settlements against the pharmaceutical industry remained low in 2016 and 2017, with federal criminal penalties nearly disappearing.
[Created on 3/14/2018]

Press Statement: By Rejecting False Hope Act, Lawmakers Spare Patients Serious Harm (HRG Publication #2407)
We applaud the House members who voted against the seriously flawed False Hope legislation, which would have created a dangerous, uncharted pathway for accessing experimental medications that have not been shown to be safe or effective.
[Created on 3/13/2018]

Letter to the U.S. House of Representatives Opposing the Newest “False Hope” Legislation (HRG Publication #2406)
In a letter to the U.S. House of Representatives, Public Citizen strongly opposed the “Right to Try Act of 2018.” Although the bill has several improvements over the Senate-passed version of this legislation (S. 204), it still has fundamental flaws that make it dangerous for patients. In particular, the bill would offer false hope to patients by creating a dangerous pathway for access to experimental drugs and biological products that bypasses the Food and Drug Administration’s existing Expanded Access program.
[Created on 3/12/2018]

Press Statement: The U.S. House of Representatives Should Reject the Newest Version of False Hope Act (HRG Publication #2405)
Public Citizen strongly opposes the newest version of the “False Hope” Act (the “Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018”). Although the legislation has several improvements over the U.S. Senate-passed version (S. 204), the bill still would offer false hope to patients by creating a dangerous pathway for access to experimental medications and biological products that bypasses the Food and Drug Administration’s existing Expanded Access program.
[Created on 3/12/2018]

Comments on the FDA’s Proposed Voluntary Malfunction Summary Reporting Program for Manufacturers (HRG Publication #2404)
Public Citizen strongly opposes the Food and Drug Administration’s (FDA’s) proposal to allow voluntary, quarterly malfunction summary reporting for class III devices and those class II devices that are permanently implantable, life-supporting, or life-sustaining.
[Created on 2/26/2018]

Supplement to the Petition to the FDA to Ban Olmesartan-Containing Hypertension Medications (HRG Publication #2403)
Public Citizen submitted a supplement to its petition the Food and Drug Administration (FDA) to ban the sale of all medication containing the widely prescribed angiotensin II receptor blocker (ARB) olmesartan medoxomil because it can cause a severe gastrointestinal disorder that leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss. Since the submission of our petition, a new large cohort study was published that provides additional evidence showing that use of olmesartan is associated with a higher rate of sprue-like enteropathy compared with the use of other ARBs.
[Created on 2/1/2018]

Letter Calling on Senator Chuck Grassley to Examine OHRP’s Failure to Adequately Protect Human Research Subjects (HRG Publication #2402)
Public Citizen sent a letter to Senator Chuck Grassley urging him to broadly examine the adequacy of the Office for Human Research Protections’ (OHRP’s) compliance oversight activities and demand that the agency cease abusing its discretion when deciding whether to initiate evaluations of noncompliance allegations. The letter noted that OHRP now routinely bypasses its own procedures for investigating allegations of misconduct, which in turn signals to the research community that there is little chance the agency will investigate even serious allegations of regulatory violations.
[Created on 2/1/2018]

Letter to Congress Opposing the Proposal to Grant Two Years of Exclusivity for Certain Over-the-Counter Drugs (HRG Publication #2401)
Public Citizen expressed concerns with the proposal to grant two years of exclusivity for certain over-the-counter (OTC) drugs that is included in the September 11, 2017, House of Representatives’ discussion draft of the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. While Public Citizen supports many of the measures included in the Act that would enable the Food and Drug Administration to better ensure that OTC drugs are safe and effective, we are concerned that the proposal to grant two years of exclusivity for certain OTC drugs could have negative repercussions for consumers.
[Created on 1/16/2018]

Letter to Congress Opposing Legislation That Would Expand Promotion of Drugs for Unapproved Uses (HRG Publication #2400)
Public Citizen sent a letter to members of U.S. House of Representatives’ Energy and Commerce Committee urging them to oppose legislation that would further erode the restrictions on the promotion of drugs for unapproved (off-label) uses that have been approved by the Food and Drug Administration for at least one use. The bill would threaten patient health and safety by undermining the current regulatory regime for ensuring that drugs are safe and effective for each intended use.
[Created on 1/16/2018]

Panel Presentation at the Johns Hopkins University Bloomberg School of Public Health Symposium: Transparency at the U.S. Food and Drug Administration (HRG Publication #2399)
Public Citizen advocated that the Food and Drug Administration follow the lead of its European and Canadian counterpart agencies and: 1) notify the public when an application to market a new drug or new use for an already-marketed drug is rejected by the agency or withdrawn by the company; and 2) release its analyses of data submitted in support of such rejected or withdrawn applications.
[Created on 1/16/2018]

STAT First Opinion: Right-to-Try Legislation Offers False Hope and Would Endanger Patients (HRG Publication #2398)
In an invited commentary, Dr. Michael Carome, director of Public Citizen’s Health Research Group, explains why so-called “right-to-try” legislation that was passed by the U.S. Senate and is now being considered by the U.S. House of Representatives would create a dangerous, uncharted pathway for patients to access experimental medications. The legislation would effectively undermine the FDA’s safety rules regarding the use of experimental drugs outside the context of a clinical trial, putting countless patients at risk.
[Created on 1/16/2018]

Commentary Advocating That the FDA Disclose Information Related to Rejected or Withdrawn New Drug Applications (HRG Publication #2397)
Public Citizen’s Health Research Group published a commentary in the Journal of Law, Medicine & Ethics advocating that the Food and Drug Administration (FDA) follow the lead of its European and Canadian counterpart agencies and: 1) notify the public when an application to market a new drug or new use for an already-marketed drug is rejected by the agency or withdrawn by the company; and 2) release its analyses of data submitted in support of such rejected or withdrawn applications.
[Created on 1/16/2018]

Press Statement: Public Citizen Applauds European Medicines Agency Committee Recommendation to Ban Dangerous IV Solutions, Calls on FDA to Immediately Follow Suit (HRG Publication #2396)
Public Citizen applauds the decision by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee to recommend removing all hydroxyethyl starch (HES) intravenous (IV) solutions from the market, although this action comes nearly five years too late. The Food and Drug Administration (FDA) must now follow suit with an immediate ban on HES solutions in the U.S.
[Created on 1/12/2018]

Comments to the FDA Supporting Draft Guidance Restricting Orphan Drug Designations for Pediatric Uses (HRG Publication #2395)
Public Citizen filed comments supporting a Food and Drug Administration (FDA) draft guidance, in which the FDA declared that it would no longer grant orphan drug designation to drugs for use in pediatric subpopulations of common diseases or conditions unless: 1) The disease in the pediatric population constitutes a valid orphan subset, or 2) the disease in the pediatric subpopulation is a different disease from the disease in the adult population.
[Created on 1/11/2018]

Testimony Before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee Regarding Testosterone Undecanoate (Tlando) (HRG Publication #2394)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Bone, Reproductive and Urologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Lipocine’s oral testosterone undecanoate capsules (Tlando) because of serious safety concerns.
[Created on 1/10/2018]

2017

Petition to the FDA to Ban Pharmacy Compounding of Cesium Chloride (HRG Publication #2393)
Public Citizen petitioned the Food and Drug Administration (FDA) to ban the use of the cancer treatment ingredient cesium chloride in pharmacy compounding because of serious health risks. FDA staff determined more than 18 months ago that cesium chloride has not been shown to be effective for “the prevention or treatment of any form of cancer,” presented “serious safety concerns,” and is “not safe for human use.”
[Created on 12/6/2017]

Letter to Congress Opposing the Proposal to Grant Two Years of Exclusivity for Certain Over-the-Counter Drugs (HRG Publication #2392)
Public Citizen expressed concerns with the proposal to grant two years of exclusivity for certain over-the-counter (OTC) drugs that is included in the September 11, 2017, House of Representatives’ discussion draft of the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2017.
While Public Citizen supports many of the measures included in the Act that would enable the Food and Drug Administration to better ensure that OTC drugs are safe and effective, we are concerned that the proposal to grant two years of exclusivity for certain OTC drugs could have negative repercussions for consumers.
[Created on 11/20/2017]

Comments to the FDA on the Presentation of Risk Information in Prescription Drug Direct-to-Consumer Broadcast Ads (HRG Publication #2391)
Public Citizen submitted comments to the Food and Drug Administration (FDA) pointing out that a study commissioned by the agency to justify its potential proposal to decrease the amount of risk information required to be disclosed in prescription drug direct-to-consumer (DTC) broadcast ads is fundamentally incomplete, flawed, and overly narrow in scope. Public Citizen urged the agency to issue a legally binding final rule regarding DTC broadcast ads that would: 1) maintain its current requirements regarding which risks must be disclosed, while requiring that severe, serious, or actionable risks be disclosed more prominently; 2) require all risk information to be disclosed in both audio and visual formats; and 3) ban the use of distracting imagery and sounds during the disclosure of risk information.
[Created on 11/20/2017]

Petition to the FDA to Ban Olmesartan-Containing Hypertension Medications (HRG Publication #2390)
Public Citizen petitioned the Food and Drug Administration (FDA) to ban the sale of olmesartan medoxomil – an angiotensin II receptor blocker (ARB) found in the widely prescribed hypertension medications marketed under the brand names Azor, Benicar, Benicar HCT and Tribenzor, as well as in other generic versions – because it can cause a severe gastrointestinal disorder that leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss.
[Created on 11/15/2017]

Comments to the EMA’s Pharmacovigilance Risk Assessment Committee Regarding the Safety of Hydroxyethyl Starch Solutions (HRG Publication #2389)
Public Citizen calls on the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) to follow the example of Sweden’s Medical Products Agency and require the immediate removal of hydroxyethyl starch (HES) solutions from the market in Europe because the solutions cause kidney failure, bleeding, and death and there are safer alternatives available. Recent drug utilization studies in 10 European Union countries indicate the futility of the PRAC’s 2013 decision to restrict the use of HES products in Europe.
[Created on 11/14/2017]

Comments on FDA Guidance Regarding IRB Waiver of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects (HRG Publication #2388)
Public Citizen urged the Food and Drug Administration (FDA) to issue expanded guidance that includes a discussion of the types of clinical investigations for which the agency might consider an institutional review board’s (IRB’s) waiver of informed consent to be appropriate from both an ethical and regulatory perspective.
[Created on 9/22/2017]

What Does a Pro-Patient, Pro-Public Health Regulatory Agency Look Like? (HRG Publication #2387)
In a post to Yale University’s CRITical Thinking blog, we discuss key features of a pro-patient, pro-public health agenda for the regulation of medical products. The blog post is derived from a presentation made at the June 2017 international conference hosted by the Yale Collaboration for Research Integrity and Transparency (CRIT) titled “Ensuring Safety, Efficacy, and Access to Medical Products in the Age of Global Deregulation.”
[Created on 9/13/2017]

Testimony Before the FDA’s Medical Imaging Drugs Advisory Committee Regarding the Safety of Linear Gadolinium-based Contrast Agents (HRG Publication #2386)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Medical Imaging Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA adopt the approach of the European Medicines Agency and ban and restrict linear gadolinium-based contrast agents used in MRIs because they can remain deposited in the brain for months or even years and, with certain exceptions, offer no unique benefits over potentially safer, more widely used macrocyclic gadolinium-based products.
[Created on 9/8/2017]

Letter to the U.S. House of Representatives Opposing Senate Bill That Would Provide False Hope to Seriously Ill Patients (HRG Publication #2385)
Public Citizen and 16 other groups sent a letter to members of the U.S. House of Representatives urging them to oppose S. 204, which is deceptively titled the “Right to Try Act of 2017” but should instead be called the “False Hope Act of 2017.” The legislation, as amended and passed by the U.S. Senate on August 3, 2017, would put countless patients at risk by undermining important FDA safety rules related to the use and oversight of unapproved, experimental medications.
[Created on 9/5/2017]

Public Citizen Urges OSHA Not To Eliminate Most Beryllium Protections for Construction, Shipyard Workers (HRG Publication #2384)
Public Citizen submitted comments strongly urging the Occupational Safety and Health Administration (OSHA) not to: 1) finalize its proposal to rescind, for construction and shipyard workers, all ancillary provisions from its final 2017 beryllium rule; 2) delay for one year the deadline for compliance by construction and shipyard employers with the final beryllium standard; or 3) abdicate its duty to protect workers by refusing to enforce the final beryllium rule for construction and shipyard workers while this latest proposal is pending.
[Created on 8/28/2017]

Letter to Congress Opposing Legislation That Would Provide False Hope to Terminally Ill Patients (HRG Publication #2383)
Public Citizen and 17 other groups sent a letter to members of Congress urging them to oppose legislation that would most appropriately each be titled the “False Hope Act of 2017.” The legislation would put countless patients at risk by dramatically undermining the FDA’s role in ensuring that medical products are safe and effective before they become widely used.
[Created on 8/2/2017]

Complaint Letter to the OHRP and the VA Office of Research Oversight Regarding an Unethical Clinical Trial Involving Heart Attack Patients (HRG Publication #2382)
Public Citizen calls on the Office for Human Research Protections (OHRP) and the Department of Veterans Affairs (VA) Office of Research Oversight to immediately suspend the National Institutes of Health-funded Myocardial Ischemia and Transfusion (MINT) trial that is expected to involve 3,500 heart attack patients throughout the U.S. and Canada because of potentially serious ethical and regulatory violations.
[Created on 8/1/2017]

Testimony Before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Regarding A New Extended-Release Oxycodone Product (HRG Publication #2381)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees, Public Citizen urges the FDA to reject Intellipharmaceutics’ new version of oxycodone because, contrary to agency guidelines, the company has not conducted any human abuse potential studies of the drug to support a labeling claim that the drug deters intravenous abuse.
[Created on 7/26/2017]

Letter to FDA Opposing Approval of Liraglutide (Victoza) for Cardiovascular Risk Reduction (HRG Publication #2380)
In a letter to the Food and Drug Administration (FDA), Public Citizen urged the FDA not to approve liraglutide (Victoza) for the additional indication of reducing cardiovascular risk in type 2 diabetes patients because the clinical trial to support such approval failed to show any benefit in the 2,500 U.S. subjects in the trial. The study only showed a significant benefit in non-U.S. subjects.
[Created on 7/18/2017]

New Study Shows Medicare ACOs Won’t Tell How They Pay Doctors (HRG Publication #2379)
Ninety-one percent of the accountable care organizations (ACOs) that provide care to 9 million Medicare enrollees refuse to disclose their physician payment incentives, according to new research published today in the American Journal of Public Health. The study was conducted by researchers from Montefiore Medical Center in New York, City University of New York at Hunter College, and Public Citizen.
[Created on 7/12/2017]

Letter to Congress Opposing Draft Legislation That Would Expand Promotion of Medical Products for Unapproved Uses (HRG Publication #2378)
Public Citizen sent a letter to members of Health Subcommittee of the U.S. House of Representatives’ Energy and Commerce Committee urging them to oppose draft legislation that would significantly expand marketing for unapproved uses of drugs and medical devices that have been approved or cleared by the FDA for at least one use. The legislation would undermine regulatory standards for ensuring that drugs and medical devices are safe and effective for each marketed use.
[Created on 7/11/2017]

Public Citizen Opposes OSHA’s Proposal to Delay Compliance With Its New Workplace Injury Reporting Rule (HRG Publication #2377)
Public Citizen opposes the Occupational Safety and Health Administration’s (OSHA’s) proposal to delay the deadline, from July 1 to December 1, 2017, for certain employers to submit injury and illness data electronically under its final rule entitled “Improve Tracking of Workplace Injuries and Illnesses”. The proposed postponement is unnecessary and will impede identification of workplace health and safety hazards.
[Created on 7/7/2017]

Op-Ed in RealClearHealth on the Trump Administration’s Proposal to Weaken OSHA’s Beryllium Standard (HRG Publication #2376)
In an op-ed in RealClearHealth, Public Citizen harshly criticized a Trump administration proposal to eliminate the “ancillary provisions” of the Occupational Safety and Health Administration’s beryllium rule that would have extended specific new protections to construction and shipyard workers, including exposure assessments, personal protective equipment, medical surveillance and protected work areas.
[Created on 6/30/2017]

Public Citizen Harshly Criticizes Proposal to Roll Back Parts of the Beryllium Rule (HRG Publication #2375)
Proposal Would Continue to Put Workers in Construction and Shipyard Industries at Risk of Cancer and Chronic Beryllium Disease
[Created on 6/23/2017]

Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Liraglutide (Victoza) for Cardiovascular Risk Reduction (HRG Publication #2374)
Public Citizen testified against the additional approval of liraglutide (Victoza) for reducing cardiovascular risk in diabetes patients because the clinical trial to support such approval failed to show any benefit in the 2,500 American subjects in the trial. The study only showed a significant benefit in non-U.S. subjects.
[Created on 6/20/2017]

Letter to the OHRP Regarding Major Ethical and Regulatory Lapses in the Conduct of the SUPPORT Trial (HRG Publication #2373)
Public Citizen requests that the Office for Human Research Protections (OHRP) immediately expand its ongoing compliance oversight investigation of the Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants (SUPPORT) trial to evaluate newly uncovered information — recently obtained by Public Citizen under the Freedom of Information Act — that reveals additional major ethical lapses and failures to materially comply with key requirements of federal regulations for the protection of human subjects.
[Created on 6/14/2017]

Press Statement: The FDA Should Never Have Approved Opana ER (HRG Publication #2372)
Public Citizen today applauded the U.S. Food and Drug Administration (FDA) for urging Endo to take Opana ER off the market, while criticizing the fact that the FDA approved it and blasting Endo Pharmaceuticals’ defiant response to the request.
[Created on 6/9/2017]

Letter to Congress Opposing Legislation That Would Expand Promotion of Medical Products for Unapproved Uses (HRG Publication #2371)
Public Citizen and 12 other groups sent a letter to members of U.S. House of Representatives’ Energy and Commerce Committee urging them to oppose two bills that would significantly expand marketing for unapproved uses of drugs and medical devices that have been approved or cleared by the FDA for at least one use. The legislation would undermine regulatory standards for ensuring that drugs and medical devices are safe and effective for each marketed use.
[Created on 6/5/2017]

Are We Finally Ready to Do Something About Big Pharma’s Price-Gouging? (HRG Publication #2370)
Public Citizen published an article on Other98.com that outlines the true causes for high drug prices in the U.S. and makes the case for why consumers should rally behind the recently introduced Affordable Meds Act to rein in monopoly abuses by Big Pharma and make medicines affordable.
[Created on 5/19/2017]

Letter to the Editor of The Hill Criticizing a Recent Op-Ed on OSHA’s Beryllium Rule (HRG Publication #2369)
In a letter to the editor of The Hill, Public Citizen criticized a recent op-ed (“Beryllium broadside: Obama’s last-minute rule-making will cost jobs”) for unfairly decrying the U.S. Occupational Safety and Health Administration’s (OSHA’s) efforts to protect workers from exposure to beryllium in the workplace.
[Created on 5/17/2017]

Comments to the FDA on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (HRG Publication #2368)
In comments to the Food and Drug Administration (FDA) on manufacturer communications regarding unapproved uses of approved or cleared medical products, Public Citizen discusses the risks to patients when manufacturers promote their products for unapproved uses and the unreliability of journal articles as a basis for physicians’ decisionmaking. We also explain that the First Amendment does not support the industry call for relaxation of the restrictions on promoting products for uses that the FDA has not approved as safe and effective for patients.
[Created on 4/19/2017]

Letter to the FDA About the Agency’s Failure to Provide Timely Notice of an Advisory Committee Meeting (HRG Publication #2367)
Public Citizen expressed serious concern regarding the Food and Drug Administration’s (FDA’s) failure to provide timely notice in the Federal Register of the April 13, 2017, meeting of the Antimicrobial Drugs Advisory Committee in accordance with the requirements of the agency’s own regulations. In the event that the agency fails to provide timely notice of advisory committee meetings in accordance with all regulatory requirements with respect to future advisory committee meetings, we will pursue available legal avenues to ensure compliance.
[Created on 4/13/2017]

Press Statement: Venture Capitalist Gottlieb Has Too Many Conflicts to Run FDA; We Need a Nominee Who Will Protect Public Health Instead of Industry (HRG Publication #2366)
Dr. Gottlieb’s appointment as FDA Commissioner would further accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients. We urge other senators to oppose Dr. Gottlieb’s nomination. The Senate should demand a nominee who is better suited to protect public health, rather than a venture capitalist who is ridden with conflicts of interest.
[Created on 4/4/2017]

Testimony Before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Regarding Reformulated Opana ER (HRG Publication #2365)
In testimony before a joint meeting of the Food and Drug Administration’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees, Public Citizen concludes that the risks of reformulated Opana ER (extended release oxymorphone) outweigh its benefits and recommends that the drug be withdrawn from the market.
[Created on 3/14/2017]

Public Citizen Urges OSHA Not to Further Delay Beryllium Rule’s Implementation (HRG Publication #2364a)
Public Citizen filed comments urging the Occupational Safety and Health Administration (OSHA) to reject a proposal to delay the effective date of its final beryllium rule. The proposal would postpone the effective date of the rule by 60 days, from the current date of March 21, 2017 to May 20, 2017, and would therefore put workers’ lives at risk.
[Created on 3/13/2017]

Press Statement: Trump’s FDA Pick Has Extensive Industry Ties and Dangerous Deregulatory Ideas (HRG Publication #2364)
Dr. Scott Gottlieb, President Trump’s pick to be Commissioner of the Food and Drug Administration (FDA), is entangled in an unprecedented web of Big Pharma ties. He has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry, and the U.S. Senate must reject him.
[Created on 3/10/2017]

Press Statements From Experts in Response to the ACGME Board’s Reckless Vote to Loosen Medical Resident Work Hour Rules (HRG Publication #2363)
The ACGME announced that effective July 1, 2017, it has rescinded the current 16-hour shift limit for first-year medical residents (also known as interns) and will allow them to work 28-hour or longer shifts without sleep.
[Created on 3/10/2017]

Letter to Congress Opposing Legislation That Would Provide False Hope to Terminally Ill Patients (HRG Publication #2362)
Public Citizen sent a letter to members of Congress urging them to oppose three bills with various names — S. 204, H.R. 878 and H.R. 1020 —that would most appropriately each be titled the “False Hope Act of 2017.” These bills provide false hope to patients and are related to a nationwide lobbying effort funded by the Goldwater Institute, which has deceptively branded such laws as “Right to Try” legislation. The legislation would put countless patients at risk by dramatically undermining the FDA’s role in ensuring that medical products are safe and effective before they become widely used.
[Created on 3/6/2017]

Press Statement: Trump’s Joint Address Attack on FDA Signals Complete Ignorance of Medication Approval Process (HRG Publication #2361)
President Trump’s claims that the U.S. Food and Drug Administration’s approval process for medical products is “slow and burdensome” and “keeps too many advances … from reaching those in need” reflect complete ignorance about the FDA’s current regulatory schemes for ensuring that medications and medical devices are safe and effective.
[Created on 3/1/2017]

Press Statement: DeLauro Proposal Would Close Dangerous Gap in FDA Regulatory Authority (HRG Publication #2360)
Public Citizen applauds Rep. Rosa DeLauro for introducing commonsense legislation that would finally give the FDA the authority to order recalls of potentially tainted medications that pose an unacceptable health risk to patients.
[Created on 2/16/2017]

Letter to the EMA Urging a Ban of Hydroxyethyl Starch Solutions in Europe (HRG Publication #2359)
Public Citizen and two leading medical experts sent a letter to the European Medicines Agency (EMA), urging the agency to ban hydroxyethyl starch (HES) solutions from the European market because the solutions cause kidney failure, bleeding, and death and there are safer alternatives available. Public Citizen and the two experts also sent the agency a copy of a petition submitted on the same day to the Food and Drug Administration (FDA) that asked the FDA to remove HES solutions from the U.S. market.
[Created on 2/8/2017]

Petition to the FDA to Ban Hydroxyethyl Starch Solutions (HRG Publication #2358)
Public Citizen and two leading medical experts petitioned the Food and Drug Administration (FDA) to remove hydroxyethyl starch (HES) solutions from the market because the solutions cause kidney failure, bleeding, and death and there are safer alternatives available.
[Created on 2/8/2017]

Petitions Delivered to the ACGME Urging Rejection of a Dangerous Resident Work Hours Proposal (HRG Publication #2357)
Board Expected to Vote on Dangerous Proposal Within the Next Few Weeks
[Created on 2/3/2017]

Press Statements: Trump Proposal to Eviscerate FDA Regulations Would Endanger Public Health (HRG Publication #2356)
Statements of Public Citizen Experts
[Created on 1/31/2017]

Public Citizen Applauds OSHA’s Final Beryllium Rule (HRG Publication #2355)
New Rule Will Save 94 Lives, Prevent 46 New Cases of Chronic Beryllium Disease Each Year
[Created on 1/6/2017]

2016

Petition to the FDA to Require a Warning About a Dangerous Drug Interaction Between Clopidogrel (Plavix) and Repaglinide (Prandin) in the Label for Both Drugs (HRG Publication #2354)
Public Citizen petitions the Food and Drug Administration (FDA) to require that the labels of the anti-clotting drug clopidogrel (Plavix) and the diabetes drug repaglinide (Prandin) warn doctors and patients that taking the drugs together can cause dangerously low blood sugar levels. The petition also asks that the drugs’ labels include a statement that the two drugs should never be taken together under any circumstances.
[Created on 12/21/2016]

Press Release: FDA Wrong to Remove Chantix’s Black Box Warning Based on One Flawed Study, Sets Dangerous Precedent for Future Medication Safety (HRG Publication #2353)
Smoking Cessation Medication Can Cause Psychiatric and Neurologic Side Effects
[Created on 12/19/2016]

Comments on a Proposal by an ACGME Task Force to Loosen Medical Resident Duty-hour Requirements (HRG Publication #2352)
Public Citizen commented on a proposal by an Accreditation Council for Graduate Medical Education (ACGME) task force to revise the requirements on medical resident work hours. Public Citizen strongly opposed several dangerous provisions, including allowing first-year residents to work 28 or more hours without sleep (up from the current limit of 16 hours), allowing all residents to work longer than even the 28-hour maximum shift length without needing to document or monitor such instances, removing the 8-hour minimum time off after shifts of less than 24 hours in length, and removing the cap of six night shifts in a row. These provisions are an alarming step back and further endanger the health and safety of residents and their patients.
[Created on 12/15/2016]

Presentation at the Meeting of the Committee on Issues in Organ Donor Intervention Research, National Academies of Sciences • Engineering • Medicine (HRG Publication #2351)
Public Citizen explained to the Committee on Issues in Organ Donor Intervention Research why such research clearly involves human subjects research. Such research must be reviewed and approved by an institutional review board, and researchers must obtain the informed consent of the organ transplant recipients who are the subjects of this research.
[Created on 12/14/2016]

Press Statement: Pharma, Medical Device Industries Got an Early Christmas Present, But Not Everything on Their List (HRG Publication #2350)
Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group
[Created on 12/7/2016]

Press Statement: 21st Century Cures: Bad Deal for Patients. Senate Should Reject (HRG Publication #2349)
Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group
[Created on 11/30/2016]

Comments on the FDA’s Draft Guidance on Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees (HRG Publication #2348)
Public Citizen and seven other groups expressed serious concerns that the proposed guidance would encourage the Food and Drug Administration (FDA) to continue inappropriately excluding advisory committee members from participating in committee meetings based on an “intellectual bias” — a phrase that does not appear in the draft guidance but that the FDA now routinely uses when screening individual advisory committee members for conflicts of interest prior to committee meetings.
[Created on 11/25/2016]

Testimony Before the FDA’s Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (HRG Publication #2347)
Public Citizen testified at a Food and Drug Administration (FDA) public hearing on “off-label marketing” – the pharmaceutical and medical device industry practice of marketing medications and medical devices for unapproved uses. Public Citizen experts explain that restrictions on marketing for unapproved uses are crucial to protecting patient health. Promotion of medical products for unapproved uses threatens patients because it undermines the long-standing regulatory framework for ensuring that medications and medical devices are safe and effective for their intended uses.
[Created on 11/9/2016]

Press Release: Proposal to Allow First-Year Resident Physicians to Work 28 Hours in a Row Puts Residents, Patients, Public at Risk of Serious Injury, Death (HRG Publication #2346)
Americans Overwhelmingly Oppose ACGME Work-Hour Proposal
[Created on 11/4/2016]

Public Citizen Urges Congress to Abandon the Dangerous 21st Century Cure Act (HRG Publication #2345)
Public Citizen and 12 other groups sent a letter to Congressional leaders urging them to abandon the dangerous 21st Century Cures Act. The legislation includes a grab bag of goodies for Big Pharma and medical device companies that would undermine requirements for ensuring safe and effective drugs and medical devices and the affordability of these medical products.
[Created on 11/3/2016]

Press Release: Federal Officials Agree With Public Citizen: Kidney Transplant Experiment Violated Federal Human Research Rules (HRG Publication #2344)
Public Citizen Had Called for Investigation Into Blatant Ethics Violations and for Disclosure to Patients Who Were Unwitting Experimental Subjects
[Created on 10/27/2016]

Comments on the FDA’s Draft Guidance on Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B (HRG Publication #2343)
Public Citizen, in general, supports the policies expressed in the Food and Drug Administration’s (FDA’s) draft guidance document. In particular, the proposed guidance appropriately seeks to tightly limit, under section 503B, pharmacy compounding of drug products that are essentially copies of approved drug products. Stringent limits on such pharmacy compounding under section 503B are critically important to protecting public health. We suggest some minor changes to strengthen the guidance.
[Created on 10/11/2016]

Comments on the FDA’s Draft Guidance on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A (HRG Publication #2342)
Public Citizen, in general, supports the policies expressed in the Food and Drug Administration’s (FDA’s) draft guidance document. In particular, the proposed guidance appropriately seeks to tightly limit, under section 503A, pharmacy compounding of drug products that are essentially copies of a commercially available drug product. Stringent limits on such pharmacy compounding under section 503A are critically important to protecting public health. We suggest some minor changes to strengthen the guidance.
[Created on 10/11/2016]

Press Statement: Patient Safety Threatened by HHS Refusal to Close Dangerous Loophole That Allows Health Care Providers to Evade Malpractice Reporting (HRG Publication #2341)
Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group
[Created on 9/22/2016]

Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding the Black Box Warning on the Smoking Cessation Drug Varenicline (Chantix) (HRG Publication #2340)
In testimony presented at a joint meeting of the Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee discussing whether to remove a boxed warning on the smoking cessation drug varenicline (Chantix), Public Citizen urged the committees to retain the boxed warning as a critical reminder to patients and their doctors that varenicline can cause potentially life-threatening psychiatric and neurologic side effects. The committees are considering whether to remove the boxed warning based on a single clinical trial that was fundamentally flawed and incapable of detecting the increased risk of such side effects, thousands of which have been reported to the FDA since varenicline’s approval in 2006.
[Created on 9/14/2016]

Letter to the University of Pennsylvania, Johns Hopkins Bloomberg School of Public Health (HRG Publication #2339)
Public Citizen and the American Medical Student Association urged the lead institutions for the iCOMPARE trial to immediately take whatever actions are necessary to terminate the trial. Allowing the continued unwitting enrollment of tens of thousands of patient subjects in the trial, in the face of national poll data showing that the vast majority of the adult public would want to be informed of this experiment if they were admitted to one of the experimental-group hospitals, would constitute an egregious, knowing disregard for the basic ethical principle of respect for persons.
[Created on 9/13/2016]

Letter to Northwestern University Presenting Results of a National Poll Question Related to the Unethical FIRST Trial Comparing Standard and Long Work Schedules for General Surgery Residents (HRG Publication #2338)
Public Citizen and the American Medical Student Association urged Northwestern University to immediately take whatever actions are necessary to terminate the FIRST trial. Allowing the continued unwitting enrollment of tens of thousands of patient subjects in the trial, in the face of national poll data showing that the vast majority of the adult public would want to be informed of this experiment if they were admitted to one of the experimental-group hospitals, would constitute an egregious, knowing disregard for the basic ethical principle of respect for persons.
[Created on 9/13/2016]

Letter to OHRP Presenting Results of a National Poll Question Related to the Unethical FIRST and iCOMPARE Trials Comparing Standard and Long Work Schedules for Medical Residents (HRG Publication #2337)
Public Citizen and the American Medical Student Association again called on the Office for Human Research Protections (OHRP) to launch formal investigations into the FIRST and iCOMPARE trials and to use its legal authority to suspend the iCOMPARE trial. Allowing the continued unwitting enrollment of tens of thousands of patient subjects in these trials, in the face of national poll data showing that the vast majority of the adult public would want to be informed of this experiment if they were admitted to one of the experimental-group hospitals, would constitute an egregious, knowing disregard for the basic ethical principle of respect for persons.
[Created on 9/13/2016]

Letter to the ACGME Regarding Public Citizen’s Report, Bipartisan Consensus: The Public Wants Well-Rested Medical Residents to Help Ensure Safe Patient Care (HRG Publication #2336)
Public Citizen and the American Medical Student Association (AMSA) provided the Accreditation Council for Graduate Medical Education (ACGME) with the results of a national poll showing that Americans overwhelmingly oppose any weakening of the current 16-hour shift limit for first-year residents (interns) and support a similar cap on upper-level residents’ work shifts. Public Citizen and AMSA urged the ACGME to (1) maintain its 16-hour cap for interns and extend the 16-hour cap to all residents; and (2) take action to stop the unethical iCOMPARE and FIRST trials.
[Created on 9/13/2016]

Public Citizen Report: Bipartisan Consensus: The Public Wants Well-Rested Medical Residents to Help Ensure Safe Patient Care (HRG Publication #2335)
Public Citizen released a report on the results of a new national poll showing that the vast majority of the American public favors restricting medical resident work shifts to no more than 16 straight hours without sleep. The report also summarizes research conducted to date on the dangers of sleep deprivation in residents to both the residents and their patients. The poll comes as the Accreditation Council for Graduate Medical Education (ACGME) is facing intense pressure from dozens of physician organizations to lift the current 16-hour shift cap for first-year medical residents and allow them to work 28 or more hours in a row without sleep.
[Created on 9/13/2016]

Comments on the FDA’s Draft Guidance on Updating Generic Drug Labeling After The Marketing Application For The Reference Listed Drug Has Been Withdrawn (HRG Publication #2334)
The draft guidance is a small step toward filling the safety gap that exists because generic drug manufacturers lack authority to initiate labeling changes based on new safety information. To more fully address the problem, we urge the Food and Drug Administration (FDA) to move promptly to finalize the November 2013 proposed rule entitled “Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products.”
[Created on 9/9/2016]

Op-Ed in the Pensacola News Journal Regarding the Incarceration of Seriously Mentally Ill Individuals (HRG Publication #2333)
In a joint op-ed, Public Citizen and the Treatment Advocacy Center discuss results of their recent report on a comprehensive national survey that captured the perspectives of county jail staff about inmates with serious mental illnesses. The op-ed highlights the need to stop the enduring tragedy that jails have become warehouses for the seriously mentally ill.
[Created on 8/7/2016]

Testimony Before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Regarding Extended-Release Morphine Sulfate (Arymo) (HRG Publication #2332)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen opposed approval of extended-release morphine sulfate (Arymo) because of serious concerns about increased risk of abuse, given its easy manipulability and unsatisfactory performance in oral human abuse likeability studies. We also urged that the FDA’s guidance for industry, “Abuse-Deterrent Opioids—Evaluation and Labeling,” be withdrawn and replaced with a regulation more favorable to patients than to opioid makers.
[Created on 8/4/2016]

Comments on the FDA’s Draft Guidances on the Prescription Requirement Under Section 503A and the Facilities Definition Under Section 503B (HRG Publication #2331)
Public Citizen supports policies contained in these two recent FDA guidances, which generally serve to clarify the line between traditional pharmacy compounding and drug manufacturing. In particular, we agree that Section 503A limits traditional compounding pharmacies from selling “office stock” in bulk to healthcare practitioners, approve of clear limitations on anticipatory compounding, and approve of the requirement that all products produced by outsourcing facilities comply with current good manufacturing practices.
[Created on 7/18/2016]

Individuals With Serious Mental Illnesses in County Jails: A Survey of Jail Staff’s Perspectives (HRG Publication #2330)
Public Citizen and the Treatment Advocacy Center are releasing a comprehensive national survey that captures the perspectives of county jail staff about inmates with serious mental illnesses. According to the report, 21 percent of the surveyed county jails reported that 16 percent or more of their inmates were seriously mentally ill. The report presents the challenges faced by county jail staff, including the limited training they are given to address the needs of these inmates, who do not belong in jails to begin with.
[Created on 7/14/2016]

Letter to U.S. Congress Conference Committee for the Comprehensive Addiction and Recovery Act (HRG Publication #2329)
Public Citizen strongly opposed a section of the House version of the Comprehensive Addiction and Recovery Act that would increase payments under Medicaid programs to opioid manufacturers for “abuse-deterrent” formulations of opioid drugs. This provision is a misguided handout to an industry that needs no additional incentives to develop and market new abuse-deterrent opioids.
[Created on 7/1/2016]

Petition to the FDA to Require a Black-Box Warning for Dopamine Agonist Drugs (HRG Publication #2328)
Public Citizen petitions the Food and Drug Administration (FDA) to add stronger warnings to the labeling for dopamine agonist drugs (apomorphine, bromocriptine, cabergoline, pramipexole, ropinirole, and rotigotine) to alert doctors and patients to the risk of impulse-control problems and compulsive behaviors, including pathological gambling, hypersexuality, and compulsive shopping and eating.
[Created on 6/29/2016]

Comments on the FDA’s Proposed Rule to Ban All Powdered Medical Gloves (HRG Publication #2327)
Public Citizen supports the Food and Drug Administration’s (FDA’s) proposed rule that would ban all powdered surgeon’s and patient examination gloves. We strongly disagree with how long this proposal has taken to be put forth. FDA’s history of past, inexcusable and dangerous delays is cause for concern about how promptly this proposed ban will be finalized.
[Created on 6/20/2016]

Testimony Before the FDA’s Drug Safety and Risk Management Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding ALO-02 (Oxycodone/Naltrexone) (HRG Publication #2326)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen opposed approval of the combination opioid product ALO-02 because of serious concerns about increased risk of abuse, given its easy manipulability. We also urged that the FDA’s guidance for industry, “Abuse-Deterrent Opioids —Evaluation and Labeling,” be withdrawn and replaced with a regulation more favorable to patients than to opioid makers.
[Created on 6/8/2016]

Press Statement: Energy Department Outpaces OSHA in Protecting Workers from Beryllium (HRG Publication #2325)
Public Citizen applauds the U.S. Department of Energy (DOE) for issuing a proposed rule that, for the second time in 17 years, would bring its Chronic Beryllium Disease Prevention Program in line with current evidence on the dangers of beryllium. The DOE’s proposal stands in sharp contrast with the actions of the U.S. Occupational Safety and Health Administration (OSHA), which has yet to lower its workplace beryllium limit from an outdated level set in 1971.
[Created on 6/7/2016]

Public Citizen Statement to the FDA on Pharmacy Compounding Issues Related to Use of Bulk Substances and Office Stock (HRG Publication #2324)
In a statement to Food and Drug Administration (FDA) officials during a listening session with consumer groups, Public Citizen urged the FDA to prevent compounding using bulk drug substances that have been identified as unsafe or ineffective by FDA reviewers. We also expressed strong support for the FDA’s proposal to prevent compounding pharmacies from engaging in compounding large quantities of products for sale to healthcare providers as office stock.
[Created on 6/6/2016]

Public Citizen Comments on Proposed FDA Guidance on Labeling for Biosimilars (HRG Publication #2323)
Public Citizen supports the Food and Drug Administration’s (FDA’s) proposal to keep the labels of biosimilars free of data from clinical trials used to demonstrate biosimilarity, similar to the labeling approach taken with generic drugs. We also support the FDA’s proposal to require that manufacturers of biosimilars promptly update the labeling of such products with new safety and efficacy information, as this policy will allow important new warnings to reach patients and doctors promptly.
[Created on 6/3/2016]

Press Statement: Lawmakers’ Proposal Would Turn Patients Into Guinea Pigs (HRG Publication #2322)
A letter from U.S. Representatives Fred Upton (R-Mich.) and Joseph Pitts (R-Pa.) shows a lack of appreciation for the role of the Food and Drug Administration (FDA) in protecting patient health and a naive view of industry marketing practices. The threat to patient health posed by the draft bill attached to their letter is tremendous.
[Created on 5/27/2016]

New Study Shows NIH-Funded Oxygen Experiment on Premature Babies Was Unethical, Parents of Babies Were Misled (HRG Publication #2321)
Contrary to statements made in consent forms signed by the parents of most premature babies enrolled in a controversial government clinical trial, some key procedures being used in the experiment were inconsistent with usual or standard care for such babies, a new study published by researchers at Public Citizen and National Institutes of Health (NIH) study published in the medical journal PLOS ONE shows.
[Created on 5/19/2016]

Press Statement: Delay in Generics Labeling Rule Leaves Patients at Risk (HRG Publication #2320)
The Food and Drug Administration’s (FDA’s) postponement to April 2017 of an important patient safety rule endangers the millions of us who take prescription medications. The FDA is plainly bowing to industry pressure and, in the process, prioritizing industry profits over patient health and safety. At this point, we worry about the agency’s commitment to finalizing the rule, which it acknowledged in 2013 would improve drug safety.
[Created on 5/19/2016]

Press Statement: Keeping Limits on Medical Resident Work Hours Is the Right Thing to do, but the Unethical FIRST Trial Must End (HRG Publication #2319)
We are relieved to hear that the Accreditation Council for Graduate Medical Education (ACGME) will not be loosening restrictions on medical resident work hours for the upcoming academic year. However, we are disturbed to learn that the ACGME is extending the waiver of some of the organization’s current key work hour restrictions and providing funding to allow the continuation of the highly unethical Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial for a third year.
[Created on 5/18/2016]

Press Statement: Safety Issues Prompt NIH Overhaul of Clinical Center Leadersh (HRG Publication #2318)
The findings of the just-released Clinical Center Working Group report highlight a stunning failure of National Institutes of Health (NIH) leadership at the highest levels. In particular, the report found that NIH has fostered a culture in which protecting patients and human research subjects from risk sometimes takes a back seat to the demands of researchers.
[Created on 5/11/2016]

Additional Comments Submitted on OSHA’s Proposed Beryllium Rule (HRG Publication #2317)
In response to a request from the Occupational Safety and Health Administration (OSHA) for additional comments on its proposed standard to protect workers from beryllium, Public Citizen submitted final comments on the standard. Public Citizen’s Dr. Sammy Almashat and Emily Gardner commented on provisions of the rule relating to outdoor workers, such as abrasive blasters, and the medical surveillance of all workers exposed to beryllium. The comments supplemented recent testimony by Almashat and Gardner at a hearing held by OSHA on the proposed standard.
[Created on 5/6/2016]

Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Regarding Opioid Analgesics (HRG Publication #2316)
In testimony before a joint meeting of the Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen called for legally mandated training for doctors who prescribe powerful opioid painkillers as a condition of obtaining or renewing their Drug Enforcement Agency narcotics licenses.
[Created on 5/4/2016]

Complaint Letter to the Office for Human Research Protections and the Department of Veterans Affairs Regarding an Unethical Kidney Transplant Experiment (HRG Publication #2315)
Public Citizen called on the Office for Human Research Protections and the U.S. Department of Veterans Affairs’ (VA’s) Office of Research Oversight to investigate a clinical trial involving kidney transplant patients that was unethical and violated rules for the protection of human subjects. The major problem is that the institutional review board (IRB) at the lead institution for the study incorrectly determined that this research constituted “nonhuman subjects research under U.S. federal law.” As a result of this clear error, the IRB failed to adequately review and approve the trial in accordance with regulations to protect human subjects and failed to ensure that the researchers obtained the voluntary informed consent from the subjects.
[Created on 4/20/2016]

Letters to CMS and the Joint Commission Requesting Roll Back of Pain Assessment Requirements That Foster Dangerous Overprescribing of Opioids (HRG Publication #2314)
In an effort to reduce overprescribing of opioid pain relievers, dozens of health care organizations, medical experts and consumer advocacy groups – including Public Citizen – sent petitions today to the Joint Commission, an agency that accredits health care organizations, and to the Centers for Medicare and Medicaid Services (CMS). Petition signers are requesting changes to requirements for assessing patients’ pain that they believe foster dangerous opioid analgesic prescribing practices.
[Created on 4/13/2016]

Letter to the Editor of The Washington Post Criticizing a Recent Op-Ed on Cuba (HRG Publication #2313)
In a letter to the editor of The Washington Post, Public Citizen pointed out that a Mar. 27th Op-Ed (“5 Myths About Cuba”) critiquing Cuba’s healthcare system relied solely on anecdotes and conflicted with the overwhelming evidence demonstrating Cuba’s healthcare advances in the face of a five-decade-old U.S. embargo.
[Created on 4/8/2016]

Letter to the Texas State Board of Pharmacy Asking the Agency to Shut Down a Dangerous Compounding Pharmacy in Texas (HRG Publication #2312)
Public Citizen strongly urges the Texas State Board of Pharmacy to suspend immediately the pharmacy license for I.V. Specialty — a compounding pharmacy based in Austin that produces a wide range of sterile drugs for home infusion — and the licenses of all pharmacists employed by the company. These state regulatory actions are urgently needed to protect patients from potentially life-threatening infections: A recent inspection of I.V. Specialty by the Food and Drug Administration (FDA) found multiple serious violations of standard procedures for producing sterile injectable drugs, and the company recklessly refused to follow the FDA’s recommendations to discontinue production of injectable drugs and to recall all of its unexpired injectable drug products.
[Created on 4/6/2016]

Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2015 (HRG Publication #2311)
Public Citizen published a report that catalogues all major financial settlements and court judgments between pharmaceutical companies and federal and state governments from 1991 through 2015. The report found that drugmakers entered into 373 settlements totaling $35.7 billion in criminal and civil penalties, but that both the number and size of settlements decreased significantly in 2014 and 2015.
[Created on 3/31/2016]

Press Statement: Eighteen Years Too Late: FDA Finally Heeds Public Citizen’s Call, Moves to Ban Powdered Latex Surgical Gloves – and All Powdered Medical Gloves (HRG Publication #2310)
Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group
[Created on 3/21/2016]

Testimony at OSHA Hearing on the Agency’s Proposed Beryllium Rule (HRG Publication #2309)
Sammy Almashat and Emily Gardner testified at the Occupational Safety and Health Administration’s (OSHA’s) two-day public hearing on OSHA’s proposed rule to update its regulation on airborne beryllium exposures in the workplace. Dr. Almashat urged OSHA to lower its proposed exposure limit even further in order to adequately protect as many workers as possible, while Ms. Gardner noted that the more than 23,000 construction and shipyard workers regularly exposed to beryllium also must be protected under the new rule.
[Created on 3/21/2016]

Testimony Before the FDA Workshop on Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy (HRG Publication #2308)
Two overarching problems are highlighted by the INRatio/ROCKET AF case: (1) The inadequacy of the low Food and Drug Administration (FDA) legal standard of substantial equivalence [510(k)] for devices needed to monitor life-threatening conditions; and (2) The dangerous failure of parties involved — the FDA, the Rocket AF investigators, Janssen/Bayer, and the INRatio manufacturers — to promptly investigate, communicate serious device warnings to all other parties, and take appropriate, necessary actions.
[Created on 3/18/2016]

Testimony Before the FDA’s Circulatory System Devices Panel Regarding the AngelMed Guardian System (HRG Publication #2307)
Public Citizen strongly opposes approval of the premarket approval application for the AngelMed Guardian System. The results of the single pivotal randomized, controlled trial for the device, the ALERTS study, fail to provide a reasonable assurance that the device is effective for the proposed indication, and the conduct of the study was marred by serious protocol violations and post hoc modifications. The device also has serious risks that are not justifiable given the lack of evidence of effectiveness.
[Created on 3/16/2016]

Press Statement: Effort to Weaken Rules on Resident Physician Work Hours Threatens Safety of Residents and Their Patients (HRG Publication #2306)
On March 16, the Accreditation Council for Graduate Medical Education (ACGME) is convening a two-day, invitation-only National Congress to discuss limits on medical resident work hours. Any effort to increase the number of consecutive hours resident physicians can work without sleep threatens the health of both residents and their patients, and should be rejected.
[Created on 3/15/2016]

Letter to the HHS Acting Assistant Secretary for Health Regarding the Unethical iCOMPARE Trial (HRG Publication #2305)
Public Citizen and the American Medical Student Association request an urgent meeting with the Department of Health and Human Services’ (HHS) Acting Assistant Secretary for Health and the Director of the Office for Human Research Protections to discuss OHRP’s failures to suspend the unethical iCOMPARE trial and to launch an investigation into the research. In light of the increasingly overwhelming evidence of widespread, serious ethical and regulatory violations involving the trial, a decision by OHRP to not initiate a formal for-cause compliance oversight evaluation of all institutions participating in this unethical trial would constitute an unacceptable abuse of the agency’s discretion and an abrogation of its fundamental responsibility to protect human subjects.
[Created on 3/9/2016]

Second Follow-up Letter to OHRP Regarding the Unethical iCOMPARE Trial (HRG Publication #2304)
Public Citizen and the American Medical Student Association express dismay at the failures of the Office for Human Research Protections (OHRP) to suspend the unethical iCOMPARE trial and to launch an investigation into the research. Newly obtained government documents regarding the trial, which forces some first-year medical residents to work dangerously long shifts, provide further evidence that the trial violates basic ethical principles and federal regulatory requirements for the protection of human subjects.
[Created on 3/9/2016]

Statement Before the Science Board to the Food and Drug Administration Regarding Opioid Drug Products (HRG Publication #2303)
If today’s meeting is more than a public relations effort for the Food and Drug Administration (FDA) to show that it is concerned about opioids, then maybe the FDA will listen to the Science Board. The board needs to let the FDA know that the Risk Evaluation and Mitigation Strategy (REMS) programs for opioids require an overhaul. Prescriber education will be ineffective unless past misinformation is explicitly and forcefully corrected.
[Created on 3/1/2016]

Public Citizen, Partners Petition FDA for Black-Box Warnings on Opioids, Benzodiazepines About Dangers of Concurrent Use (HRG Publication #2302a)
Public Citizen and partners including several representatives of state health departments petition the Food and Drug Administration (FDA) to require black-box warnings on the labels of opioid painkillers and benzodiazepine tranquilizers to warn of the dangers of concurrent use. There are more than 14,000 deaths in the U.S. each year due to overdose of prescription opioid painkillers, and a rapidly increasing proportion of these deaths occurs in people prescribed benzodiazepines as well as opioids. This increase is not registering with prescribing doctors, however, necessitating a change in the labeling of these medications to better inform and protect patients.
[Created on 2/22/2016]

Follow-up Letter to OHRP Regarding the Unethical iCOMPARE Trial Comparing Standard and Long Work Schedules for Internal Medicine Residents (HRG Publication #2302)
Public Citizen and the American Medical Student Association again call on the Office for Human Research Protections (OHRP) to immediately suspend the iCOMPARE trial and to launch an investigation into the research. Documents recently obtained by Public Citizen from NIH provide additional clear evidence that the iCOMPARE trial, as designed and currently being conducted, violates basic ethical principles and federal regulatory requirements related to the protection of human subjects. OHRP’s failure to take action is troubling, and the agency’s continued inaction makes it a culpable party in this unethical research.
[Created on 2/11/2016]

Public Citizen Opposes Medical Device Bills to Be Marked Up Before Senate Committee (HRG Publication #2301)
Public Citizen writes to the Senate Health, Education, Labor, and Pensions Committee to oppose two bills that are scheduled to be marked up March 9, 2016. The bills would advance dangerous provisions weakening the Food and Drug Administration’s (FDA’s) power to regulate medical devices. One measure would lower approval standards for products that combine devices with drugs or biological products, and the other would pressure the FDA to take shortcuts that would lower the quality of information available for FDA review of medical devices. Both bills should be rejected, and no Senate-passed measures should be combined with the 21st Century Cures legislation, which would put patient lives at risk and compromise public health.
[Created on 2/8/2016]

New Health Research Group Study Examines Physician Sexual Misconduct in the National Practitioner Data Bank (HRG Publication #2300)
Published today in PLOS ONE, the study shows that only a small number of physicians (n=1,039) were reported to the National Practitioner Data Bank due to sexual misconduct — that have led to sanctions by medical boards, hospitals or other health care organizations, or have led to malpractice payments — over a recent almost 10-year period. Interestingly, state medical boards did not take any actions against two thirds of the physicians with sanctions by hospitals or other health care organizations or malpractice payments related to this unethical behavior.
[Created on 2/3/2016]

Press Statement: New England Journal of Medicine Violates Its Own Policy, Publishes Results of Unethical FIRST Trial That Put Resident Doctors at Risk (HRG Publication #2299)
The New England Journal of Medicine editors’ decision to publish the results of the unethical, seriously flawed Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial violates the journal’s own policy requiring authors to provide assurances related to the protection of human subjects. Furthermore, the trial yielded the self-serving results sought by the trial’s researchers, whose stated goal before the trial began was to roll back mandatory limits on physician resident work hours that were adopted in 2011 to protect both the residents and their patients from serious harm.
[Created on 2/2/2016]

Comments on the CDC’s Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain (HRG Publication #2298)
Public Citizen strongly supports the Centers for Disease Control and Prevention’s (CDC’s) proposed 2016 Guideline for Prescribing Opioids for Chronic Pain. The proposed guideline provides common-sense, evidence-based recommendations for primary care providers who prescribe opioids for chronic pain and would represent an important step forward in efforts to address the severe drug addiction epidemic in the U.S. that has been fueled by overprescribing of opioids.
[Created on 1/13/2016]

Complaint Letters to the Department of Veterans Affairs Regarding the Unethical CHAMPION PHOENIX Clinical Trial (HRG Publication #2297)
Public Citizen called on the Department of Veterans Affairs’ (VA) Office of Research Oversight to investigate the unethical CHAMPION PHOENIX clinical trial, which involved three VA medical centers. The trial needlessly increased the risk of death, heart attack and other adverse cardiac events for subjects placed in the control group of the trial by exposing them to substandard care. In a separate letter to the VA’s Office of Inspector General, Public Citizen called for an investigation into whether the inappropriate care provided to subjects in the CHAMPION PHOENIX trial extended to clinical care of patients who did not participate in the trial.
[Created on 1/7/2016]

Comments on the Proposed Revisions to the Federal Regulations for the Protection of Human Subjects (HRG Publication #2296)
Public Citizen provides detailed comments on the notice of proposed rulemaking (NPRM) that would extensively revised the Federal Policy for the Protection of Human Subjects. The NPRM would transform the regulations — which are currently written in clear, concise, and, in most respects, easily understood language — into a document that is exceedingly confusing, overly complex, and written in very opaque language in multiple sections.
[Created on 1/6/2016]

2015

Comments on the FDA’s Draft Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (HRG Publication #2295)
Public Citizen objects to the Food and Drug Administration’s (FDA’s) proposed interim policy that will allow outsourcing facilities to mass-produce drugs using bulk drug substances that are not currently on a list of drug shortages maintained by the FDA or on a list of bulk drug substances developed for which there is a clinical need. The proposed interim policy poses a threat to public health.
[Created on 12/22/2015]

Comments on the FDA’s Draft Interim Policy on Compounding Drugs Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act (HRG Publication #2294)
Public Citizen objects to the Food and Drug Administration’s (FDA’s) proposed interim policy that will allow pharmacies to compound drugs using bulk drug substances that that are not components of drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act, the subject of U.S. Pharmacopeia or National Formulary monographs, or drug substances appearing on the 503A bulk list while the agency undertakes the task of evaluating nominations for the 503A bulk list. The proposed interim policy poses a threat to public health.
[Created on 12/22/2015]

Letter Responding to the ACGME’s Defense of the iCOMPARE and FIRST Trials Comparing Standard and Long Work Schedules for Medical Residents (HRG Publication #2293)
The Accreditation Council for Graduate Medical Education (ACGME) response to Public Citizen and the American Medical Student Association’s November 19, 2015, letter regarding the iCOMPARE and FIRST trials fails to substantively address the major concerns about the trials’ serious ethical lapses and instead represents a misleading attempt by the ACGME to absolve itself of any responsibility for its central role in this unethical research. Public Citizen renewed its call for the ACGME to rescind its waivers of important work hour limits for medical residents that it granted to hospitals and residency training programs participating in the iCOMPARE and FIRST trials.
[Created on 12/16/2015]

Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Simvastatin/Ezetimibe (HRG Publication #2292)
Public Citizen opposes approval of ezetimibe in combination with simvastatin for the proposed indication of reducing the risk of cardiovascular events in patients with coronary heart disease. Results of the IMPROVE-IT study failed to provide substantial evidence to support approval for this indication.
[Created on 12/14/2015]

Press Statement: Unseemly and Inappropriate: FDA Joined With the Medical Device Industry in Drafting Cures Legislation (HRG Publication #2291)
It should be unimaginable that the most senior Food and Drug Administration (FDA) officials would collude with the lead medical device trade association to write legislation to weaken the agency’s regulatory oversight and approval standards for medical devices. But that is exactly what appears to have happened. The result is contained within the House-passed 21st Century Cures Act – more accurately known as the False Cures Act – which would eviscerate the already far-too-weak safety rules for medical devices.
[Created on 12/11/2015]

Letter to FDA on Serious Problems With INRatio Measuring Device Used in ROCKET AF Anticoagulant Trial (HRG Publication #2290)
Public Citizen urges the FDA to investigate the possible impact of inaccurate measurements, by a device called INRatio, on subjects’ anticoagulation during the ROCKET AF trial, which sought to compare the standard anticoagulant warfarin with the newer drug rivaroxiban (Xarelto). Public Citizen has found 1,445 injury and almost 10,000 FDA malfunction reports connected with this device , raising serious questions about the validity of the study’s findings. FDA Commissioner nominee Dr. Robert Califf co-chaired the steering committee advising Johnson and Johnson on the study and should thus recuse himself from any investigation.
[Created on 12/10/2015]

Public Citizen Report: House Orphan Drug Proposal: A Windfall for Pharma, False ‘Cure’ for Patients (HRG Publication #2289)
In July 2015, the U.S. House of Representatives passed the 21st Century Cures Act, a bill purported to provide “help and hope for patients through biomedical innovation.” Yet in many ways the “cure” presented by the bill is a false one. For example, one provision of the bill would give an extra six months of monopoly protection to manufacturers for brand-name medications granted an additional approval to treat an orphan disease. Public Citizen’s report explains how this provision could cost U.S. taxpayers, private insurers, and patients nearly $12 billion over the next ten years, while accelerating the current trend of non-innovative research into orphan drugs.
[Created on 12/8/2015]

Letter to the FDA Urging the Agency not to Approve the New Drug Application for Lesinurad (HRG Publication #2288)
Public Citizen opposes Food and Drug Administration (FDA) approval of the new drug application for lesinurad for treatment of hyperuricemia associated with gout because the drug offers meager clinically meaningful benefits relative to placebo for gout patients with hyperuricemia and has serious risks, including definite significant kidney toxicity and possible cardiovascular toxicity. FDA approval — with reliance on warnings in the product labeling, a risk evaluation and mitigation strategy, and postmarket safety studies — would be a reckless approach and would not be in the interests of public health.
[Created on 12/7/2015]

Press Statement: FDA Delay in Safety Rule Leaves Patients Nationwide at Risk (HRG Publication #2287)
The Food and Drug Administration (FDA)’s postponement to July 2016 of a significant patient safety rule leaves open a safety gap for the millions of patients who take generic medications. The agency proposed the rule in 2013 in response to a 2011 Public Citizen petition.
[Created on 12/3/2015]

Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee Regarding Gepirone (HRG Publication #2286)
Public Citizen strongly opposes Food and Drug Administration (FDA) approval of gepirone for treatment of depression. The drug showed such poor results in clinical testing that its approval by the FDA would effectively weaken standards for approval of new antidepressants.
[Created on 12/1/2015]

Letter to the ACGME Regarding the iCOMPARE and FIRST Trials Comparing Standard and Long Work Schedules for Medical Residents (HRG Publication #2285)
Public Citizen and the American Medical Student Association urge the Accreditation Council for Graduate Medical Education (ACGME) to rescind waivers of its work hour limits for medical residents that it granted to hospitals and residency training programs participating in the iCOMPARE and FIRST trials. Neither of these unethical trials could have proceeded without the ACGME’s waivers.
[Created on 11/19/2015]

Letter to OHRP Regarding the FIRST Trial Comparing Standard and Long Work Schedules for General Surgery Residents (HRG Publication #2284)
Public Citizen and the American Medical Student Association call on the Office for Human Research Protections to immediately launch an investigation of the FIRST trial and to sanction all hospitals that participated in the trial. The trial — an experiment involving general surgery residents and their patients without their consent — was highly unethical and failed to comply with federal regulations for the protection of human subjects involved in research.
[Created on 11/19/2015]

Letter to OHRP Regarding the iCOMPARE Trial Comparing Standard and Long Work Schedules for Internal Medicine Residents (HRG Publication #2283)
Public Citizen and the American Medical Student Association call on the Office for Human Research Protections to immediately suspend the iCOMPARE trial and to launch an investigation of the research. The trial — an experiment involving internal medicine residents and their patients without their consent — is highly unethical and fails to comply with federal regulations for the protection of human subjects involved in research.
[Created on 11/19/2015]

Testimony Before the FDA’s Antimicrobial Drugs and Drug Safety and Risk Management Advisory Committees Regarding Fluoroquinolone Antibiotics (HRG Publication #2282)
Public Citizen is concerned about the significant overprescribing of fluoroquinolones. We recommend that the Food and Drug Administration (FDA) require the addition of black-box warnings to the labels of all such antibiotics about the risk of life-threatening abnormal heart rhythms.
[Created on 11/5/2015]

Comments Urging OSHA to Finalize a More Protective Beryllium Rule (HRG Publication #2281)
Public Citizen filed comments urging the U.S. Occupational Safety and Health Administration (OSHA) to finalize a safer beryllium rule than the one it proposed, specifically one that would: a) include a lower permissible exposure limit to airborne beryllium of 0.1 micrograms per cubic meter of air (μg/m3) and a short-term exposure limit of 1.0 μg/m3; and b) cover construction and shipyard workers who comprise 40 percent of all beryllium-exposed workers. Public Citizen also encouraged OSHA to commission or conduct a feasibility study assessing the feasibility of compliance with a permissible exposure limit of 0.05 μg/m3 consistent with the evidence-based recommendation of the American Conference of Governmental Industrial Hygienists.
[Created on 11/5/2015]

Comments to the FDA on Biosimilar Naming (HRG Publication #2280)
Public Citizen issued comments to the Food and Drug Administration (FDA) concerning its draft guidance on the naming of biosimilar medications. The comments largely agree with the FDA’s proposals in the guidance, while urging the agency to engage in greater pharmacovigilance efforts and to assign identical names for interchangeable biosimilars, in order to facilitate their use.
[Created on 10/27/2015]

Testimony Before the FDA’s Arthritis Advisory Committee Regarding Lesinurad (HRG Publication #2279)
Public Citizen opposes Food and Drug Administration (FDA) approval of the new drug application for lesinurad for treatment of hyperuricemia associated with gout because the drug offers meager clinically meaningful benefits relative to placebo for gout patients with hyperuricemia and has serious risks, including definite significant renal toxicity and possible cardiovascular toxicity. As a result, the drug would cause much more harm than benefit.
[Created on 10/23/2015]

Testimony Before the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Regarding the Essure Female Sterilization Device (HRG Publication #2278)
The Food and Drug Administration (FDA) should withdraw approval for the female sterilization device, Essure, because it causes long-term, debilitating pain and other chronic side effects in some women. Additionally, Public Citizen raised significant concerns regarding how serious adverse events and patient satisfaction were assessed during clinical testing of the device.
[Created on 9/24/2015]

Letter to California Governor Endorsing Four Bills to Regulate Psychotropic Medication Use in Foster Children (HRG Publication #2277)
Thousands of California foster children are medicated with psychotropic drugs with little oversight and without assurance that the treatments are safe and appropriate and that other, safer treatments have been tried first. Public Citizen’s Health Research Group urges the governor of California to sign Senate Bills (SBs) 238, 319, and 484, and to direct his staff to resolve any outstanding issues on SB 253, which, together, address and more stringently regulate this dangerous medication overuse.
[Created on 9/21/2015]

Press Statement: Senate Should Reject President’s Nominee to Be the Next FDA Commissioner (HRG Publication #2276)
The Senate should reject President Barack Obama’s nomination of Dr. Robert Califf to be the next commissioner of the U.S. Food and Drug Administration (FDA). His nomination undoubtedly comes as welcome news to the pharmaceutical and medical device manufacturers, but is bad news for patients and public health.
[Created on 9/16/2015]

Coalition Letter to U.S. Senate Finance Committee Calls for Release of Findings of Investigation of Opioid Makers (HRG Publication #2275)
In a letter sent to the U.S. Senate Finance Committee, 36 physician groups, addiction agencies and consumer advocacy organizations, including Public Citizen, request public release of the results of a 2012 investigation by the committee into financial ties between producers of pain medications and organizations that aggressively promote the medications.
[Created on 9/16/2015]

Press Statement: The New England Journal of Medicine Continues to Defend Unethical Clinical Trial Involving Premature Babies (HRG Publication #2274)
Public Citizen responds to a series of baseless accusations leveled by the editors of the New England Journal of Medicine. The editors have accused Public Citizen of misinforming the public by drawing attention to an unethical clinical trial involving 1,316 premature infants, whose parents were not properly informed of the true nature and purpose of the research or its risks. In our rebuttal, we criticize the editors for continuing to publish misleading and unbalanced assessments of the study, which are beneath the standards of this prestigious journal.
[Created on 9/3/2015]

Press Statement: HHS Proposal Leaves Many Human Subjects at Risk (HRG Publication #2273)
Today, the U.S. Department of Health and Human Services (HHS), along with 15 other federal departments and agencies, issued a proposed rule that would revise federal requirements for the protection of human subjects in scientific research. The long-awaited rule from HHS, which has been under development for more than four years, represents a mixed bag of changes.
[Created on 9/2/2015]

Press Release: FDA’s Big Mistake: Expect Flibanserin to Be Pulled From the Market in a Few Years (HRG Publication #2272)
The U.S. Food and Drug Administration’s (FDA’s) decision to approve flibanserin as a treatment for women with hypoactive sexual desire presents serious dangers to women, with little benefit, and recklessly disregards the worrisome risk information in the agency’s briefing package to the advisory committees that met on June 4 to review the drug.
[Created on 8/19/2015]

Public Citizen Urges the FDA to Retract Industry-Centered “Patient Preference” Guidance (HRG Publication #2271)
In comments submitted today, Public Citizen urges the Food and Drug Administration (FDA) to retract its recent draft guidance discussing how the agency will use “patient preference” information when making decisions about whether to approve high-risk medical devices. We argue that the guidance was heavily influenced by members of regulated industry and would lower approval standards for high-risk medical devices.
[Created on 8/17/2015]

Press Release: After 14-Year Delay, OSHA Finally Proposes Lowering Legal Limit for Permissible Workplace Beryllium Exposure (HRG Publication #2270)
The U.S. Occupational Safety and Health Administration (OSHA) issued a proposed rule to modernize the beryllium workplace exposure limit. OSHA’s announcement comes 14 years after Public Citizen first petitioned for stronger protections for workers exposed to toxic levels of beryllium in a variety of workplace settings.
[Created on 8/6/2015]

Report: Medicare Part D Pays Needlessly High Brand-Name Drug Prices Compared with Other Developed Countries and with U.S. Government Programs (HRG Publication #2269)

Because of congressional restrictions on the government’s ability to negotiate with the pharmaceutical industry, Medicare Part D drug prices are significantly higher than those in either Medicaid or the Veterans Health Administration (VHA) and 30 other countries, a study by Carleton University and Public Citizen finds.

[Created on 7/23/2015]

Letter to the Editor of The Wall Street Journal Criticizing a Recent Editorial Promoting Lower Approval Standards for Antibiotics (HRG Publication #2268)
In a letter to the editor of The Wall Street Journal, “Undue Haste Rarely Yields Good Medicine,” Public Citizen strongly criticized the July 3 editorial “How to End the Regulatory Slowdown for New Antibiotics” supporting two bills in Congress designed to lower approval standards in order to speed up the approval process. The bill would be a significant step backward for drug safety in the U.S.
[Created on 7/12/2015]

Letter to U.S. House of Representatives Opposing the 21st Century Cures Act and Commenting on Proposed Amendments to the Act (HRG Publication #2267)
Public Citizen continues to strongly oppose H.R. 6, the 21st Century Cures Act, because the legislation still carries several provisions that would undermine public health and threaten patient safety. Unfortunately, several proposed amendments, which would have mitigated some of the damage that would result if H.R. 6 is enacted, were not allowed to be considered during debate of the bill on the House floor.
[Created on 7/9/2015]

Petition to the FDA to Ban the Medical Device Seprafilm (HRG Publication #2266)
Public Citizen petitions the Food and Drug Administration (FDA) to immediately remove the medical device Seprafilm from the market because it has not been shown to be safe and effective and has been associated with death and severe injury.
[Created on 7/7/2015]

Petition to FDA Concerning the Inappropriately Expanded Approval of the Sleep Drug Tasimelteon (Hetlioz) (HRG Publication #2265)
Public Citizen petitions the Food and Drug Administration (FDA) to reverse its decision to expand the approval of the sleep medication tasimelteon (Hetlioz) to patients who are not blind, as the relevant clinical trials for the drug were conducted only in totally blind patients with non-24-hour sleep-wake disorder. The petition also requests that FDA include certain animal toxicity data in the drug’s label.
[Created on 6/11/2015]

Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Evolocumab (HRG Publication #2264)
Public Citizen opposes Food and Drug Administration (FDA) approval of the new drug application for evolocumab for treatment of lipid disorders because there is insufficient information to evaluate the benefit-risk balance of the drug.
[Created on 6/10/2015]

Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Alirocumab (HRG Publication #2263)
Public Citizen opposes Food and Drug Administration (FDA) approval of the new drug application for alirocumab for treatment of lipid disorders because there is insufficient information to evaluate that benefit-risk balance of the drug.
[Created on 6/9/2015]

Testimony Before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Flibanserin (HRG Publication #2262)
Public Citizen strongly opposes Food and Drug Administration (FDA) approval of the new drug application for flibanserin for treatment of hypoactive sexual desire disorder in premenopausal women. The FDA previously rejected approval of the drug in 2010 and 2013. There is now considerably more evidence that the drug’s risks outweigh its benefits.
[Created on 6/4/2015]

Public Citizen Joins Coalition Urging Congress to Withhold Support for 21st Century Cures Act (HRG Publication #2261)
Public Citizen joins seven other groups representing consumers, physicians, researchers, and public health experts in urging Congressmembers to withhold support for the 21st Century Cures Act, as the draft legislation as written would allow for approval of unsafe and ineffective drugs, encourage the overuse of new antibiotics, undermine the Physician Payment Sunshine Act, and increase barriers for patients’ access to care.
[Created on 5/21/2015]

Public Citizen Presents before Senate Working Group on Medical Innovation (HRG Publication #2260)
Public Citizen offered a presentation before a Senate working group on medical innovation, encouraging the group to consider a bill requiring publication of the clinical trial data that forms the basis of Food and Drug Administration (FDA) drug approval decisions, and cautioning against attempting to speed up FDA approval by lowering standards for safety and effectiveness.
[Created on 5/21/2015]

Public Citizen Offers Comments on FDA’s Guidance Documents for the Pharmacy Compounding and Outsourcing Industries (HRG Publication #2259)
Public Citizen comments on three draft guidance documents put out by the Food and Drug Administration intended to offer guidance to industry on the repackaging of drugs, the mixing, diluting, and repackaging biological products, and adverse event reporting by outsourcing facilities. Public Citizen generally supports the proposed documents, but urges FDA to impose tighter requirements in some areas to protect public health.
[Created on 5/20/2015]

Public Citizen to Congress: Seven Provisions That Must Come Out Before 21st Century Cures Act Can Move Forward (HRG Publication #2258)
Public Citizen writes to Congress to express serious concerns with the latest version of the 21st Century Cures Act. The bill has been scaled back from the original publicly released draft but still carries seven provisions that would undermine public health and threaten patient safety.
[Created on 5/14/2015]

Letter to HHS Secretary Regarding Failure of OHRP to Launch Investigation of University of Minnesota’s Human Research Protection Program (HRG Publication #2257)
Public Citizen expressed alarm regarding the Office for Human Research Protections’ (OHRP) recent decisions (a) not to launch a formal investigation into the human subjects protection program at the University of Minnesota (UM); and (b) not to require UM to suspend enrollment in all ongoing human subjects research, particularly high-risk clinical trials, that had inadequate review by the UM institutional review board.
[Created on 5/13/2015]

Letter to Louisiana State Legislature Opposing a House of Representatives Bill That Would Weaken the Louisiana State Board of Medical Examiners (HRG Publication #2256)
Public Citizen calls on the Louisiana State Legislature to reject House of Representatives Bill No. 573 because it would seriously compromise patient safety in Louisiana. In particular, multiple provisions of the proposed legislation would substantially impede the Louisiana State Board of Medical Examiners’ ability to appropriately investigate allegations of physician incompetence or unprofessional conduct, to subsequently discipline physicians determined to have engaged in such misconduct, and thereby to protect the public from dangerous doctors.
[Created on 5/5/2015]

Additional Comments on the FDA’s Proposed Generic Drug Labeling Rule and an Industry Alternative (HRG Publication #2255)
Public Citizen strongly supports the Food and Drug Administration’s proposed rule, which will enable generic drug manufacturers to update product labeling with newly discovered risk information, and we urge the agency to move promptly to finalize the proposal. The industry alternative would exacerbate, rather than solve, the safety problem that the FDA proposal seeks to address.
[Created on 4/27/2015]

Testimony before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding the Drug Cangrelor (HRG Publication #2254)
Public Citizen strongly opposes approval of the anti-platelet drug cangrelor for use in patients undergoing coronary artery stenting. The key clinical trial failed to show that cangrelor is as safe and effective as other available treatments for these uses, and the design of the trial was unethical because subjects assigned to the control group received substandard anti-platelet management. The FDA again should reject the drug, as it did one year ago.
[Created on 4/15/2015]

Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding the Diabetes Drug Saxagliptin (HRG Publication #2253)
The Food and Drug Administration (FDA) should withdraw saxagliptin from the market because the large postmarket SAVOR trial demonstrated that the drug has unacceptable cardiovascular risks.
[Created on 4/14/2015]

Statement on FDA’s Denial of Public Citizen’s 2012 Petition for a Black Box Warning Recommending Against Combination Therapy with ACE Inhibitors, ARBs, and Aliskiren (HRG Publication #2252)
FDA’s denial of petition guarantees that hundreds of thousands of patients will continue to be unnecessarily exposed to the risks of combination therapy, with no added benefit over an angiotensin-converting enzyme (ACE) inhibitor, angiotensin II receptor blocker (ARB), or aliskiren given alone.
[Created on 4/8/2015]

Release of First Comprehensive State Occupational Safety and Health Standards Database (HRG Publication #2251)
Public Citizen and the Robert Wood Johnson Foundation’s Public Health Law Research program released the first comprehensive database of state occupational safety and health standards in the 25 states with a federally-approved occupational safety and health enforcement agency. The database contains all regulations and laws that have not been adopted identically from the federal Occupational Safety and Health Administration (OSHA) and that are meant to protect workers from specific workplace safety and health hazards.
[Created on 4/1/2015]

Letter to FDA on the Off-Label Promotion of Several Diabetes Drugs (HRG Publication #2250)
Public Citizen calls on the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion to halt the dissemination of direct-to-consumer advertisements for five prescription drugs approved only for the treatment of Type 2 diabetes. The ads promote the drugs for the off-label uses of weight loss and blood pressure reduction. Public Citizen also calls on the agency to fine the companies responsible for issuing the ads, an action that it has never before taken in response to such violative ads.
[Created on 3/31/2015]

Presentation at the FDA’s Public Meeting on the Proposed Rule Regarding Generic Drug Labeling (HRG Publication #2249)
Public Citizen strongly endorses the Food and Drug Administration’s proposed rule to revise regulations on generic drug labeling, an action requested in a 2011 Public Citizen petition. When finalized, the rule will allow generic drug manufacturers to update their products’ labeling to include recently acquired safety information without prior agency approval, which current FDA regulations do not allow them to do. The proposed rule will fill a longstanding, dangerous regulatory gap and provide added protection to the tens of millions of people who use generic drugs. An industry alternative proposal will not close this safety gap.
[Created on 3/27/2015]

Testimony Before a Joint Meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Fluticasone Furoate/Vilanterol (Breo Ellipta) for Asthma (HRG Publication #2248)
The FDA should not approve the combination therapy, fluticasone furoate/vilanterol (Breo Ellipta) for the treatment of asthma, because the combination medicine may be dangerous in adolescents and little is known about its safety in adults. Breo Ellipta should not be approved for asthma until a large, adequately designed clinical trial is completed demonstrating that the combination therapy is as safe as the single ingredient fluticasone furoate for both adult and adolescent patients.
[Created on 3/19/2015]

Letter to the Association for the Accreditation of Human Research Protection Programs Regarding the University of Minnesota’s Human Research Protection Program (HRG Publication #2247)
Public Citizen calls on the Accreditation of Human Research Protection Programs to immediately rescind its accreditation of the human subjects protection program at the University of Minnesota after a recent report apparently revealed the university’s failure to adequately protect human research subjects.
[Created on 3/16/2015]

Letter to OHRP Regarding the University of Minnesota’s Human Research Protection Program (HRG Publication #2246)
Public Citizen calls on the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP) to launch an investigation after a recent report apparently revealed the University of Minnesota’s failure to adequately protect human research subjects.
[Created on 3/16/2015]

Letter to the Secretary of Health and Human Services Urging Withdrawal of FDA Guidance on Distribution of Risk Information (HRG Publication #2245)
Nearly 1,800 people or organizations — including individual consumers, doctors and other health professionals, academics, people working in the drug industry, pharmaceutical companies and other organizations — have responded to the Food and Drug Administration’s (FDA’s) June 2014 proposed Guidance concerning information about the safety of prescription drugs. The response, by over 99 percent, was strong opposition. The proposed guidance would undermine the authority of the agency and put patients at risk.
[Created on 3/11/2015]

Follow-up Letter to the FDA Regarding Use of Experimental Pulse Oximeter Devices in the SUPPORT Study (HRG Publication #2244)
Public Citizen presses the Food and Drug Administration for answers to key questions regarding the use of experimental oxygen monitoring devices in the SUPPORT study, which involved extremely premature babies, and the inclusion of one particularly misleading statement in many of the institutional review board-approved SUPPORT study consent forms regarding these devices.
[Created on 3/10/2015]

Testimony Before the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee Regarding Deoxycholic Acid Injection (HRG Publication #2243)
Public Citizen strongly opposes Food and Drug Administration (FDA) approval of deoxycholic acid injection for cosmetic procedures to remove chin fat because the limited benefits of the drug are outweighed by its risks. In particular, the clinical trials of the drug demonstrate that it cause nerve damage and difficulty swallowing.
[Created on 3/9/2015]

Press Statement: FDA Belatedly Warns About Testosterone Risks of Heart Attack and Stroke (HRG Publication #2242)
The U.S. Food and Drug Administration (FDA) belatedly announced today that testosterone medications have “a possible increased risk of heart attack and stroke with use.” Public Citizen petitioned the FDA for a black box warning concerning this cardiovascular risk on Feb. 25 of last year, but the FDA rejected this petition on July 16, arguing that there was “insufficient evidence” of the link between testosterone and cardiovascular risks for either a black box warning or a patient medication guide, which we had also requested.
[Created on 3/3/2015]

Petition to the FDA to Ban All Oral Forms of the Anti-Fungal Drug Ketoconazole (HRG Publication #2241)
Public Citizen petitions the Food and Drug Administration (FDA) to immediately require that the oral forms of the antifungal agent ketoconazole be removed from the market because the drug’s risks of fatal liver failure and adrenal insufficiency, and its numerous drug interactions, outweigh its limited benefits in treating fungal infections.
[Created on 2/24/2015]

Letters to 73 Hospitals Asking Them to End Their Partnerships With Life Line Screening (HRG Publication #2240)
Public Citizen today urged 73 hospitals in 24 states to sever their partnerships with Life Line Screening and stop promoting the company’s community-wide cardiovascular disease and osteoporosis screening package, which is unethical and much more likely to do harm than good.
[Created on 2/19/2015]

Press Statement: Under Hamburg, FDA Cozied Up to Industries It Regulates, Protected Corporations More Than Patients (HRG Publication #2239)
The pending resignation of U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg will end a six-year period of weak and ineffective leadership at one of the most important public health agencies in the country.
[Created on 2/5/2015]

Public Citizen Tells Federal Health Agencies: Government Should Have Acted Faster to Warn About Fake Injectable Saline (HRG Publication #2238)
Public Citizen sent a letter today to the heads of the U.S. Department of Health and Human Services, the U.S. Food and Drug Administration, and Centers for Disease Control and Prevention, accusing the agencies of failing to act swiftly and aggressively when the agencies learned that fake saline solution had been distributed to health care facilities across the country and given to patients.
[Created on 1/28/2015]

Comments on OHRP’s Draft Guidance for Disclosing Risks in Research Evaluating Standards of Care and the SUPPORT Trial (HRG Publication #2237)
Public Citizen generally supports the positions expressed by the Office for Human Research Protections (OHRP) in the draft guidance regarding the disclosure of reasonably foreseeable risks in research evaluating “standard of care” or usual care interventions. However, the draft guidance is too narrowly constrained in its scope and fundamental position statement and lacks clarity with respect to several important points.
[Created on 1/22/2015]

Letter to the FTC Regarding the Life Line Screening’s Advertising of Its Cardiovascular Disease and Osteoporosis Screening Package (HRG Publication #2236)
Public Citizen urges the Federal Trade Commission (FTC) to investigate the direct-to-consumer advertising and promotional activities of the cardiovascular disease screening company Life Line Screening. The company’s advertising materials make unsubstantiated claims about the medical benefits of its cardiovascular disease and osteoporosis screening package and omit information about the risks of adverse health-related outcomes and financial harms that may result from the screenings.
[Created on 1/22/2015]

Testimony before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Desmopressin for Nocturia (HRG Publication #2235)
Public Citizen strongly oppose Food and Drug Administration (FDA) approval of Nocdurna (desmopressin) — a drug already twice rejected by the FDA — for treatment of nocturia due to nocturnal polyuria in adults because the drug’s serious risks far outweighs its meager clinical benefits.
[Created on 1/12/2015]

2014

Comments Before the Institute of Medicine Workshop: Ethical Review and Oversight Issues in Research Involving Standard of Care Interventions (HRG Publication #2234)
In comments presented at an Institute of Medicine workshop on research involving standard of care interventions, Public Citizen emphasized the need for institutional review boards to be skeptical when investigators assert that their randomized trials are limited to standard of care interventions.
[Created on 12/2/2014]

Testimony before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee Regarding Epidural Steroid Injections (HRG Publication #2233)
Public Citizen urges the committee to recommend that the Food and Drug Administration (FDA) require a boxed warning and contraindication against the use of steroids for epidural injection, based on the fact that there is a class-wide risk of rare but catastrophic adverse neurologic events that cannot be eliminated through current mitigation strategies. This risk far outweighs any limited benefits of such injections.
[Created on 11/24/2014]

Letter to the HHS Secretary Regarding Corruption of the Process for Revising Federal Regulations for the Protection of Human Subjects (HRG Publication #2232)
Public Citizen today called on Secretary of Health and Human Services Sylvia Mathews Burwell to immediately reverse the recent decision by one or more senior officials in her immediate office, including at least her chief of staff, to abruptly transfer from the Office for Human Research Protections (OHRP) to the National Institutes of Health (NIH) the responsibility for rewriting key sections of a draft proposal to extensively revise the federal rules for the protection of human subjects. Given NIH’s obvious direct conflict of interest, such HHS action has corrupted the rulemaking process and undermined the authority of OHRP.
[Created on 11/20/2014]

Press Statement: FDA’s Partial Approval of Public Citizen’s Petition for Stronger Warnings on Certain Proton Pump Inhibitor Products Comes Too Late (HRG Publication #2231)
Although we are disappointed in the rejection of certain requests, the portions of the petition granted by the Food and Drug Administration (FDA) are important and will make the products safer. At the same time, it is unconscionable that the agency took more than three years to respond.
[Created on 11/3/2014]

Testimony Before the Secretary’s Advisory Committee on Human Research Protections Regarding OHRP’s Draft Guidance on Disclosing Risks in Research Evaluating Standards of Care and the SUPPORT Trial (HRG Publication #2230)
Public Citizen applauds the Office for Human Research Protections (OHRP) for strongly reaffirming in its October 24 Federal Register notice announcing the release of its draft guidance on risks in research evaluating standard of care that the parents of premature infants enrolled in the NIH-funded Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPPORT) were not informed of the trial’s reasonably foreseeable risks, including risks of blindness and death.
[Created on 10/29/2014]

Public Citizen to Congress: FDA’s Device Tracking Regulations Weaker than First Proposed (HRG Publication #2229)
On October 28, 2014, Public Citizen expressed concerns to the Senate Health, Education, Labor & Pensions (HELP) Committee that FDA’s final rule requiring Unique Device Identifiers (UDIs) for certain medical devices was weaker that the rule the agency had proposed previously.
[Created on 10/29/2014]

Letter to the Editor Published in Clinical Pharmacokinetics: Hepatotoxicity of Alogliptin (HRG Publication #2228)
Public Citizen criticizes a recent article published in Clinical Pharmacokinetics that concluded that “no hepatotoxicity has been reported” during the development of the diabetes drug alogliptin. However, after analyzing phase 2 and 3 pre-approval trials of alogliptin and post-marketing surveillance data for the drug from Japan, the Food and Drug Administration and European Medicines Agency concluded that the drug’s potential hepatotoxicity warranted inclusion of warning language in the drug’s label.
[Created on 10/22/2014]

Press Statement: Government Agency Confirms Parents Were Not Given Adequate Information About the Risks Posed to Their Premature Babies in NIH Trial (HRG Publication #2227)
Public Citizen applauds the position taken by the Office for Human Research Protections confirming that parents of premature infants enrolled in a government-funded study were not given adequate notice of the trial’s risks. The position comes in a Federal Register notice today announcing the availability of the agency’s draft guidance document, “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.”
[Created on 10/22/2014]

Letter to HHS Secretary Opposing FDA Guidance for Distribution of Risk Information (HRG Publication #2226)
The U.S. Food and Drug Administration (FDA) should release all comments to the public that were submitted about a recent proposal to allow the pharmaceutical industry to circumvent labeling rules and tell doctors that its products have fewer risks than those described in FDA-approved labeling, Public Citizen said in a letter to Secretary of Health and Human Services Sylvia Mathews Burwell today. Public Citizen calls on the Secretary to order the FDA to withdraw the dangerous proposal.
[Created on 10/22/2014]

Petition to the FDA Requesting a Stronger Boxed Warning and New Restrictions on the Use of Varenicline (Chantix) (HRG Publication #2225)
Public Citizen joins four other organizations in petitioning the Food and Drug Administration (FDA) to require a more informative and comprehensive Black Box Warning for the smoking cessation drug varenicline (Chantix). The petition also asks that the FDA add restrictions to the Indications section of the product label warning against the drug’s use by individuals in sensitive or hazardous occupations, such as pilots, emergency medical workers, and others, in whom the neurological and psychiatric adverse effects of varenicline could pose a danger to themselves or others.
[Created on 10/8/2014]

Letter to Bon Secours Virginia Asking the Health System to End Its Partnerships With HealthFair (HRG Publication #2224)
Public Citizen today urged Bon Secours Virginia to sever its relationships with HealthFair because the company’s heavily promoted, community-wide cardiovascular health screening programs are unethical and are much more likely to do harm than good. A growing chorus of medical experts and leaders of prominent professional medical organizations are voicing strong opposition to HealthFair’s screening programs.
[Created on 10/7/2014]

Letter to HHS Secretary Regarding the Agency’s Decision Requiring Reporting of All HHS Malpractice Payments to the National Practitioner Data Bank (HRG Publication #2223)
When it comes to its own doctors and other health care providers, the Department of Health and Human Services (HHS) has been breaking its own policy requiring all malpractice payments to be reported to the National Practitioner Data Bank (NPDB). Public Citizen applauds the recent determination by HHS that reaffirmed a 1990 HHS policy requiring that all malpractice payments made as a result of a claim or suit filed against the U.S. government related to care provided by HHS health care practitioners be reported to the NPDB. However, we have some concerns regarding the HHS plan for implementation of the policy decision.
[Created on 9/30/2014]

Comments Supporting a More Protective Heat Stress Rule for All California Workers (HRG Publication #2222)
Public Citizen filed comments with the California Department of Industrial Relations’ Occupational Safety and Health Standards Board supporting proposed revisions to California’s occupational heat stress regulation. In addition, Public Citizen urged the Board to go further and adopt WorkSafe’s recommendations for more adequate protections from the deadly effects of extreme heat for all of California’s workers.
[Created on 9/25/2014]

Testimony before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Testosterone Products (HRG Publication #2221)
Public Citizen urges the Food and Drug Administration (FDA) to require that the product labels of all testosterone-containing medications available in the U.S. be revised to include warnings about the increased risk of heart attacks and other life-threatening cardiovascular dangers.
[Created on 9/17/2014]

Statement: Whitewash: Inspector General Review of Agency Misconduct Ignores Serious Ethical Lapses by Senior HHS Officials; Congress Should Act (HRG Publication #2220)
The Department of Health and Human Services (HHS) Office of Inspector General issued a report in response to a complaint filed by Public Citizen over interference by the National Institutes of Health in an ongoing investigation of the SUPPORT study, a controversial clinical trial involving premature infants. The inspector general’s failure to find any impropriety by high-ranking HHS officials is extremely disturbing and represents a complete whitewash. In failing to take stronger action, the OIG has become part of the problem of inadequate HHS oversight of research involving people.
[Created on 9/16/2014]

Testimony before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Liraglutide for Weight Loss (HRG Publication #2219)
Public Citizen strongly opposes the approval of liraglutide (Saxenda) for weight loss because the drug, currently approved for type 2 diabetes, has already been shown to be toxic at a lower dose than that which is being considered for weight loss, while conferring only marginal benefits on weight reduction and no proven long-term health benefits.
[Created on 9/11/2014]

Letter to the FDA Concerning its Advisory Committee-Industry Revolving Door (HRG Publication #2218)
Public Citizen called on the Food and Drug Administration to develop and implement a policy restricting current and former voting members of its advisory committees from accepting paid speaking and consulting roles on behalf of product sponsors before FDA advisory committees.
[Created on 9/10/2014]

Letter to the FTC Regarding the HealthFair’s Advertising of Its Cardiovascular Disease Screening Packages (HRG Publication #2217)
Public Citizen urges the Federal Trade Commission (FTC) to investigate the direct-to-consumer advertising and promotional activities of the cardiovascular disease screening company HealthFair. The company’s advertising materials make unsubstantiated claims about the medical benefits of its screening packages and omit information about the risks of adverse health-related outcomes and financial harms that may result from the screenings.
[Created on 9/4/2014]

Follow-up Letters to Twenty Hospitals and Medical Institutions That Are or Were Partnered With HealthFair (HRG Publication #2216)
Public Citizen today applauded the decision of three hospitals to end their partnerships with HealthFair and again urged 20 hospitals and medical institutions in eight states to sever their relationships with the company because the its heavily promoted, community-wide cardiovascular health screening programs are unethical and are much more likely to do harm than good. A growing chorus of medical experts and leaders of prominent professional medical organizations are voicing strong opposition to HealthFair’s screening programs.
[Created on 9/4/2014]

Public Citizen Opposes FDA Guidance for Distribution of Risk Information (HRG Publication #2215)
Public Citizen strongly opposes the Food and Drug Administration’s (FDA’s) draft guidance on distributing publications on risk information for prescription drugs and biological products. The FDA is proposing to allow pharmaceutical company salespeople to promote drugs to doctors with printed information that claims the medications are less risky than FDA-approved labeling says they are. This would seriously undermine FDA’s existing drug safety laws and regulations.
[Created on 8/25/2014]

Press Release: FDA Draft Guidance Would Let Pharmaceutical Industry Tell Doctors Medications Are Safer Than They Really Are (HRG Publication #2214)
The U.S. Food and Drug Administration (FDA) recently issued draft guidance that would let the pharmaceutical industry essentially circumvent drug labeling rules and tell doctors that its products have fewer risks than those described in the FDA-approved labeling. This is discussed by Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, in a Journal of the American Medical Association Internal Medicine article.
[Created on 8/15/2014]

Statement: Another Reckless FDA Action: Approval of Suvorexant (Belsomra) (HRG Publication #2213)
The U.S. Food and Drug Administration (FDA) has approved suvorexant (brand name: Belsomra), a dangerous and habit-forming sleep medication. The lowest doses of suvorexant were approved despite having never been tested in large clinical studies that are a standard requirement for all modern medication – and dosage – approvals, while the higher doses demonstrated only marginal benefits and caused serious next-day driving impairment.
[Created on 8/14/2014]

Testimony Before the FDA’s Pulmonary-Allergy Drugs Advisory Committee on Tiotropium (Spiriva Respimat) (HRG Publication #2212)
Public Citizen opposes the Food and Drug Administration’s approval of tiotropium (Spiriva Respimat) because the drug (1) offers no unique advantages over the currently available Spiriva HandiHaler; and (2) appears to have a greater risk of fatal myocardial infarction than Spiriva HandiHaler.
[Created on 8/14/2014]

Letter to HHS Secretary Regarding the Agency’s Decision Requiring Reporting of Malpractice Payments to the National Practitioner Data Bank Under Medical Malpractice Reforms in Oregon and Massachusetts (HRG Publication #2211)
Public Citizen applauds the recent determination by the Department of Health and Human Services (HHS) regarding reporting of medical malpractice payments to the National Practitioner Data Bank (NPDB). The HHS determination closes loopholes in requirements for reporting medical malpractice payments to the NPDB that were created under recently enacted laws in Oregon and Massachusetts. The HHS action is an important first step toward preserving the integrity and viability of the NPDB as a comprehensive, reliable source of data regarding malpractice payouts made on behalf of physicians and other health care practitioners.
[Created on 8/12/2014]

Comments on the FDA’s Proposed Order to Reclassify Surgical Mesh for Repair of Pelvic Organ Prolaspe (HRG Publication #2210)
Public Citizen strongly supports the Food and Drug Administration’s (FDA’s) proposed orders to up-classify surgical mesh for transvaginal repair of pelvic organ prolapse (POP) and to require the filing of premarket approval applications for these medical devices. Unfortunately, the FDA’s reckless delays and inadequate action regarding surgical mesh for POP repair have resulted, and will continue to result, in thousands of women being unnecessarily exposed to a wide array of serious risks, many of which can permanently alter their quality of life.
[Created on 7/28/2014]

Petition to the FDA to Not Allow Marketing of Over-The-Counter Benzocaine Products for Teething in Infants (HRG Publication #2209)
Public Citizen petitions the Food and Drug Administration to no longer allow over-the-counter (OTC) benzocaine products to be marketed for treating teething in infants and toddlers because they can prompt a rare but deadly adverse reaction. In addition, the agency should require a warning about this adverse reaction on all other OTC benzocaine products intended for use in older children and adults.
[Created on 7/28/2014]

Statement: Contrasting Actions by Health Canada and the FDA on Testosterone (HRG Publication #2208)
In a response to the Food and Drug Administration’s (FDA’s) denial of a petition to add a black-box warning to the product labels of all testosterone-containing drugs on the market in the U.S., Public Citizen notes that Health Canada took drastically different action in the same week. The Canadian agency issued a health warning to patients and health care providers about the serious cardiovascular risks of testosterone products, but the FDA declined to offer a similar warning, leading to the conclusion that the FDA is more sensitive to pressure from prescribing doctors and drug companies than they are to the nation’s public health needs.
[Created on 7/16/2014]

Letter to The Joint Commission Regarding HealthFair’s Unethical Cardiovascular Screening Programs (HRG Publication #2207)
Public Citizen urges The Joint Commission to investigate whether HealthFair — or any of its partnered hospitals and health care organizations — has ever misled consumers to believe that the company and its screening programs were accredited by The Joint Commission at a time when they were not. We also asked the Commission to reject any application for accreditation from HealthFair and to suspend the accreditation of any health care organization still partnered with HealthFair.
[Created on 6/30/2014]

Letters to Twenty Hospitals and Medical Institutions Asking Them to End Their Partnerships With HealthFair (HRG Publication #2206)
Public Citizen today urged 20 hospitals and medical institutions in eight states to sever their relationships with HealthFair because the company’s heavily promoted, community-wide cardiovascular health screening programs are unethical and are much more likely to do harm than good.
[Created on 6/19/2014]

Letter to the University of Minnesota President Calling for an Investigation of Psychiatric Clinical Trials (HRG Publication #2205)
Public Citizen strongly urges the University of Minnesota (UM) President to finally heed the repeated calls for an independent, transparent, and detailed inquiry into the events surrounding the horrific suicide of a human subject during his involvement in a clinical trial involving patients with schizophrenia. The scope of this inquiry must include concerns about misconduct in other psychiatric clinical trials at UM.
[Created on 6/16/2014]

Acute Pancreatitis With Liraglutide: An analysis of MedWatch adverse event reports submitted to the Food and Drug Administration (HRG Publication #2204)
A new study by Public Citizen of MedWatch adverse event reports sent to the Food and Drug Administration (FDA) reinforces the case that the diabetes drug liraglutide (brand name: Victoza), one of a class of drugs known as incretin mimetics, can cause acute pancreatitis and should be banned immediately by the FDA. Public Citizen referenced the study in a letter it sent to the FDA responding to the agency’s recent denial of Public Citizen’s 2012 petition to ban liraglutide.
[Created on 6/5/2014]

Petition to HHS to Close the Corporate Shield Loophole for Reporting Medical Practice Payments to the NPDB (HRG Publication #2203)
Public Citizen petitioned the U.S. Department of Health and Human Services (HHS) to close a loophole — known as the “corporate shield” loophole — that has allowed physicians and other health care providers to evade having medical malpractice payment reports submitted to the National Practitioner Data Bank (NPDB). Such evasions deprive users of the data bank, such as hospitals and state licensing boards, of important information about health care providers and jeopardize patient health and welfare.
[Created on 5/29/2014]

Statement: HHS Response to Public Citizen’s Finding of Agency Misconduct Doesn’t Add Up (HRG Publication #2202)
The Department of Health and Human Services (HHS) response to Public Citizen’s letter to the HHS inspector general shows a continuing attempt to cover up the unprecedented and unethical HHS/National Institutes of Health (NIH) interference in Office for Human Research Protections’ (OHRP’s) responsibility to ensure that human research is ethical. Public Citizen’s letter called for a formal investigation of NIH’s interference in OHRP’s probe of the SUPPORT study. In an initial reaction to the letter, HHS spokesperson Tait Sye, according to media reports, argued that the NIH merely worked to correct “incomplete information” in the first report issued by OHRP and that such communication was not “uncommon.” That response is not credible.
[Created on 5/20/2014]

Letter to the HHS Inspector General Calling for an Investigation Into Inappropriate Conduct by Senior HHS Officials Related to the SUPPORT Study (HRG Publication #2201)
Public Citizen, joined by nine prominent scholars in bioethics, law and history, called for an immediate investigation by the U.S. Department of Health and Human Services (HHS) Office of Inspector General into the conduct of senior HHS officials, who, according to an email trail, permitted top National Institutes of Health (NIH) officials to edit drafts of a letter documenting findings of what should have been an independent inquiry by the Office for Human Research Protections into serious ethical lapses in a major NIH trial.
[Created on 5/20/2014]

Letter to OSHA’s Advisory Committee on Construction Safety and Health on an Updated Beryllium Standard (HRG Publication #2200)
Public Citizen implores the Advisory Committee on Construction Safety and Health to recommend that the Occupational Safety and Health Administration (OSHA) include the strongest possible protections for construction workers within a new beryllium standard and to implore OSHA to move as quickly as possible to finalize the new rule.
[Created on 5/8/2014]

Public Citizen Again Opposes Reclassification of Extracorporeal Membrane Oxygenation (ECMO) Devices (HRG Publication #2199)
Public Citizen testified before the FDA’s Circulatory System Devices Panel reiterating its opposition to the reclassification of ECMO devices from Class III to Class II for two pediatric indications and opposing a potential further Class II reclassification for acute catastrophic cardiogenic shock in adult patients. The FDA should instead publish a proposed final rule maintaining the devices’ Class III classification for all indications and set an effective date requiring the submission of evidence that the device is safe and effective for all current uses.
[Created on 5/7/2014]

Testimony Before the FDA’s Nonprescription Drugs Advisory Committee on Montelukast (Singulair Allergy) (HRG Publication #2198)
Public Citizen strongly oppose Food and Drug Administration (FDA) approval of over-the-counter (OTC) montelukast because, relative to existing FDA-approved OTC products for allergic rhinitis, the drug: (1) offers marginal clinical benefit relative to placebo and generally appears to have inferior effectiveness compared to existing FDA-approved OTC allergy products and (2) poses significantly greater risk, both to patients who meet the proposed indication and to those likely to use the drug for off-label indications.
[Created on 5/2/2014]

Commentary in The New York Times’ “Room for Debate” Series on Physicians Who Participate in Capital Punishment (HRG Publication #2197)
In an invited commentary as part of The New York Times’ “Room for Debate” series, Public Citizen speaks to the ethical grounds for physicians to participate in the practice of capital punishment. Dr. Sidney Wolfe urges the revoking of medical licenses, as the practice flies in the face of a physician’s ethical code to heal and not to hurt.
[Created on 5/1/2014]

Public Citizen Sues FDA for Failing to Take Action on Petition Concerning Dangerous Proton Pump Inhibitors (HRG Publication #2196)
Public Citizen sued the U.S. Food and Drug Administration (FDA) today for failing to respond to the organization’s petition requesting black box warnings on common but dangerous anti-stomach acid drugs, known as proton pump inhibitors (PPIs). Although more than two and a half years have passed since Public Citizen filed its petition, the FDA has neither granted nor denied it, and has not required adequate warnings on the drugs.
[Created on 4/30/2014]

Statement: Too Little, Too Late: FDA Belatedly Initiates Limited Action to Address Unsafe and Ineffective Surgical Mesh Used in Pelvic Repair Procedures, as Requested by Public Citizen (HRG Publication #2195)
Public Citizen welcomes today’s long-overdue issuance of a proposed order by the U.S. Food and Drug Administration (FDA) that, if finalized, would reclassify surgical mesh for transvaginal pelvic repair organ prolapse (POP) from a moderate-risk device (class II) to a high-risk device (class III). This would subject these devices to a more rigorous approval process that would require manufacturers to submit to the agency premarket approval applications with evidence from clinical trials that the devices are safe and effective. However, the FDA’s action today is troubling both in its scope and timing.
[Created on 4/29/2014]

Testimony Before the FDA’s Analgesic and Anesthetic Drug Products Advisory Committee Meeting on Moxduo (HRG Publication #2194)
Public Citizen strongly opposes the approval of Moxduo, a drug combination containing the opioids morphine and oxycodone. Moxduo was shown to be no more effective or safer than either morphine or oxycodone alone for treating acute pain. HRG also argues that approval of this drug could further contribute to the epidemic of opioid abuse in the U.S.
[Created on 4/22/2014]

Public Citizen Urges FDA to Take Action for Sale of Misbranded Brain Stent Device (HRG Publication #2193)
Public Citizen is urging the Food and Drug Administration (FDA) to take action against Stryker Neurovascular and Boston Scientific for publishing false and misleading information on their websites regarding Wingspan Stent System devices, medical devices used to prop open narrowed blood vessels in the brains of certain types of stroke patients. The websites falsely expands the FDA-approved use of the device and also fail to report information from a critically important study that found dangers for patients using the device.
[Created on 4/3/2014]

Testimony Before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding the Drug Serelaxin (HRG Publication #2192)
Public Citizen strongly opposes the approval of serelaxin for acute heart failure because it has exceedingly marginal, if any, benefits on subjective, transient, shortness of breath symptoms and no proven benefits on any objective cardiovascular outcomes. The FDA should follow the lead of a key committee of the European Medicines Agency and the recommendation of its own clinical reviewer in rejecting the drug unless it ultimately demonstrates a clinically meaningful benefit in a larger, ongoing trial.
[Created on 3/27/2014]

Letter to Senator Joe Manchin Urging Him to Investigate FDA’s Decision to Approve Dangerous High-Dose Opioid (HRG Publication #2191)
Public Citizen commended Senator Manchin for his efforts to (a) overturn the reckless decision by the Food and Drug Administration (FDA) to approve the dangerous, high-dose, non-tamper-resistant opioid drug Zohydro ER; and (b) develop legislation that would target such seriously flawed decision-making by the agency. We also urge him to investigate why newly disclosed information about a tamper-resistant, single-drug hydrocodone product that is in the advanced stages of development failed to sway the FDA against approving Zohydro.
[Created on 3/14/2014]

Public Citizen’s Comments on the CMS Proposed Rule About the Prescriber Changes to Medicare Part D (HRG Publication #2190)
Public Citizen supports the proposed changes to the Part D program that will require all eligible prescribes to be enrolled in the Medicare Fee For Service program to be able to prescribe covered Part D drugs. Suggestions were also offered regarding the criteria to identify abusive prescribers.
[Created on 3/7/2014]

Letter to the FDA Protesting Aveed (HRG Publication #2189)
Letter to FDA protesting decision announced today to approve a long-lasting testosterone injection drug, Aveed.
[Created on 3/6/2014]

Public Citizen asks the FDA to Prohibit Traditional Compounding Pharmacies from Engaging in High Risk Sterile Compounding (HRG Publication #2188)
Public Citizen has requested that the Food and Drug Administration (FDA) prohibit traditional compounding pharmacies from engaging in nonsterile-to-sterile compounding, a particularly high-risk form of compounding, by identifying these drugs as demonstrably difficult to compound. Public Citizen also recommended that the FDA restrict compounding of metered dose inhalers, dry powder inhalers, transdermal delivery systems, sustained or time-released dosage forms, and enteric-coated preparations.
[Created on 3/4/2014]

Comments on NIOSH’s Latest Criteria for a Recommended Heat Stress Standard and Letter to OSHA Imploring Their Adoption Within a Federal Standard (HRG Publication #2187)
From 1992 to 2012 (the most recent year for which federal data are available), at least 655 workers have died and 53,564 have been severely injured by heat stress injuries. Public Citizen applauds the latest evidence-based draft criteria for a recommended heat stress standard issued by the National Institute for Occupational Safety and Health (NIOSH). We also urge the Occupational Safety and Health Administration (OSHA) to adopt NIOSH’s latest criteria recommendations on heat stress, once finalized, as the basis for a federal heat stress standard.
[Created on 2/25/2014]

Letter to the Executive Director of the European Medicines Agency on Testosterone Products (HRG Publication #2186)
On Feb. 25, 2014, Public Citizen sent a petition to the Food and Drug Administration, urging the agency to place a black box warning on all testosterone products, warning of increased risks of heart attacks and other cardiovascular dangers. In this letter to the European Medicines Agency, we urge that agency to add a similar warning due to the overwhelming evidence for such risks.
[Created on 2/25/2014]

Letter to the FDA Asking the Agency to Keep Dangerous High-Dose Opioid Drug Off the Market (HRG Publication #2185)
Public Citizen joins with more than 40 consumer organizations, health care agencies, addiction treatment providers, and community-based drug and alcohol prevention programs today in calling on the Food and Drug Administration to revoke its approval of Zohydro (oxycodone), an opioid so powerful that a single dose could kill a child.
[Created on 2/26/2014]

Petition to the FDA for Black Box Warnings on All Testosterone Products (HRG Publication #2184)
Public Citizen petitions the Food and Drug Administration to add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs presently on the market in the U.S.
[Created on 2/25/2014]

Testimony before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding the Drug Cangrelor (HRG Publication #2183)
Public Citizen strongly opposes approval of the anti-platelet drug cangrelor for use in patients undergoing coronary artery stenting procedures and for patients who need an IV anti-platelet drug while awaiting surgery. The clinical trials failed to show that cangrelor is effective for these uses, and the design of these trials was unethical because subjects assigned to the control group received substandard anti-platelet management.
[Created on 2/12/2014]

Letter to the FDA Opposing Approval of the New Drug Application for Droxidopa (HRG Publication #2182)
In a letter to the Food and Drug Administration (FDA) Public Citizen urges the agency to not approve the new drug application for droxidopa for treatment of patients with neurogenic orthostatic hypotension. There is insufficient evidence that the drug is effective or that the benefits of its use outweigh the risks. Given the lack of evidence that droxidopa is effective, FDA approval of the drug would undermine the integrity and meaningfulness of its own standard for approving drugs and cause immeasurable harm to the agency’s reputation.
[Created on 2/5/2014]

Letter to the FDA Criticizing the Agency’s Inappropriate Redaction of Advisory Committee Member Curricula Vitae (HRG Publication #2181)
In a letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg and Chief Counsel Elizabeth Dickinson, Public Citizen expresses concern about redactions of the curricula vitae (CVs) of advisory committee members that are posted on the FDA’s website. A great many of the members’ CVs have significant redactions with the notation either (b)(4) or (b)(6), referring to the Freedom of Information Act (FOIA) exemptions from disclosure that protect confidential commercial information and personal privacy. These redactions are unjustified under FOIA, and Public Citizen asks that the FDA promptly revise the web pages so that CVs appear in full.
[Created on 2/4/2014]

Public Citizen Asks the Food and Drug Administration (FDA) to Clarify the Line Between Pharmacy Compounding and Drug Manufacturing (HRG Publication #2180)
Public Citizen provided comments to the FDA regarding the agency’s draft guidance on pharmacy compounding under section 503A of the Food, Drug and Cosmetics Act. Although generally supportive of the guidance, Public Citizen raises the concern that the existing draft fails to clarify the main statutory criteria distinguishing between compounded drugs, which are intended to be individually tailored for a specifically identified patient to meet a unique or unusual clinical need, and manufactured drugs, which are mass-produced, standardized products intended for a population that shares a common set of clinical needs.
[Created on 2/3/2014]

Public Citizen’s Comments on the Draft Revision of the National Practitioner Data Bank Guidebook (HRG Publication #2179)
Public Citizen provides comments to the Health Resources and Services Administration regarding the draft revision of the National Practitioner Data Bank Guidebook. Several suggestion for improving the clarity of the Guidebook are offered.
[Created on 1/31/2014]

Letter to the FDA Calling For Black Box Warnings for the Drug Vorapaxar as a Condition of Approval (HRG Publication #2178)
Public Citizen urged the Food and Drug Administration that if it decides to approve the drug vorapaxar, as a condition of approval the agency should require a black box warning in the drug’s label. The warning should indicate that patients with prior history of stroke or transient ischemic attack should not use the drug due to the risk of drug-induced strokes. The warning also should state that patients with a body weight of less than 60 kilograms (kg) should not use the drug because of an unfavorable risk-benefit profile.
[Created on 1/29/2014]

Letter to U.S. Secretary of Health and Human Services Regarding Unethical Trial Involving Premature Infants (HRG Publication #2177)
In a letter to Health and Human Services Secretary Kathleen Sebelius, Public Citizen presents an analysis highlighting problems with the design of a clinical trial involving premature infants, known as the SUPPORT study. These problems involved inadequate monitoring for adverse events. As a result, the study design was unethical.
[Created on 1/27/2014]

2013

Presentation on Pharmacy Compounding before the Food and Drug Law Institute Enforcement, Litigation, and Compliance Conference (HRG Publication #2176)
Public Citizen Attorney Sarah Sorscher spoke on pharmacy compounding at a conference focused on enforcement by the Food and Drug Administration (FDA). Public Citizen has pushed heavily for the FDA to respond more aggressively when compounding pharmacies violate federal law. The presentation includes several examples of areas where the FDA failed to enforce federal law against compounding pharmacies in the past. The presentation also highlights Public Citizen’s concerns moving forward as the FDA implements the Drug Quality and Security Act, a new statute governing compounding that was signed into law by President Obama on November 27, 2013.
[Created on 12/18/2013]

Letter to FDA Commissioner Margaret Hamburg Criticizing Agency Messages Endorsing Compounded Drugs Made by Outsourcing Facilities (HRG Publication #2175)
Public Citizen urged the Food and Drug Administration (FDA) to stop making misleading statements that could lead health care providers to treat patients with compounded drugs produced by outsourcing facilities without understanding that they are not as safe as FDA-approved drugs.
[Created on 12/17/2013]

Letter to the FDA Calling for Public Disclosure of Meta-Analyses Performed by the Agency (HRG Publication #2174)
Public Citizen urged the Food and Drug Administration (FDA) to disclose to the public all currently completed and future FDA meta-analyses of randomized controlled clinical trials that concern the safety of FDA-regulated human drugs and biologics. In addition to disclosure of the meta-analyses, results of the individual studies that comprise the meta-analyses, and all other related data, also need to be disclosed.
[Created on 12/16/2013]

Testimony to FDA Endocrinologic and Metabolic Drugs Advisory Committee on Dapagliflozin for Treatment of Type 2 Diabetes Mellitus (HRG Publication #2173)
Public Citizen urges the agency not to approve dapagliflozin, a member of a new chemical class of drugs to treat type 2 diabetes mellitus, because it is no more effective than a similar diabetes drug, canagliflozin, approved by the FDA in March 2013, but does appear to pose additional safety hazards not seen with canagliflozin, including risks of bladder cancer and liver toxicity.
[Created on 12/12/2013]

Letter to the FDA Opposing Approval of the CardioMEMS Champion Heart Failure Monitoring System (HRG Publication #2172)
In a letter to the Food and Drug Administration Public Citizen urges the agency to not approve the CardioMEMS System for monitoring heart failure patients. There is insufficient evidence that the device is effective or that the benefits of its use outweigh the risks related to its implantation.
[Created on 12/2/2013]

Commentary in The New York Times “Room for Debate” Series on Trying Newly Approved Medications (HRG Publication #2171)
In an invited commentary as part of The New York Times’ “Room for Debate” series, Public Citizen answers the question, “How do you know whom to trust?” when it comes to drug safety. Dr. Sidney Wolfe urges patients to determine whether the maker of a drug paid for its research and to seek independent advice. Wolfe also advocates following the “seven-year rule,” which advises patients not to take a new drug for at least seven years from the drug’s release date (except in cases of rare “breakthrough” drugs with known advantages over older drugs).
[Created on 11/18/2013]

Testimony to the FDA Peripheral and Central Nervous Systems Drugs Advisory Committee on Tasimelteon for the Treatment of Blind Persons with Non-24 Hour Sleep Disorder (HRG Publication #2170)
Approval of tasimelteon, given the magnitude of post-hoc changes to the clinical trial protocol, timed so close to the end of data collection, would set an ominous precedent for future new drug development programs.
[Created on 11/14/2013]

Statement: FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety (HRG Publication #2169)
The Food and Drug Administration (FDA) today issued a proposed rule to revise regulations on generic drug labeling, responding to a 2011 Public Citizen petition. When finalized, the rule will allow generic drug manufacturers to update their products’ labeling to include recently acquired safety information without prior agency approval, which current FDA regulations do not allow them to do. The proposed rule will fill a longstanding, dangerous regulatory gap and provide added protection to the tens of millions of people who use generic drugs.
[Created on 11/8/2013]

Statement: Johnson & Johnson Settlement Nothing New for Company; Small Fine Unlikely to Prompt Change in Behavior (HRG Publication #2168)
The announcement that Johnson & Johnson will pay $2.2 billion in criminal and civil fines to the federal and state governments is the latest in a long line of multibillion-dollar health fraud settlements. Despite the seemingly large sums, the fines imposed on pharmaceutical companies for dangerous and illegal conduct pale in comparison to the profits generated from such activity.
[Created on 11/4/2013]

Follow-Up Letter to FDA Commissioner Hamburg about FDA Advisory Committee Chair Just-Cancelled Participation in Pharmaceutical Industry Conference (HRG Publication #2167)
On Oct. 24, 2013, Public Citizen’s Dr. Sidney Wolfe informed Food and Drug Administration (FDA) Commissioner Margaret Hamburg of an FDA advisory committee chair’s planned participation in a pharmaceutical industry conference. The issue received national media attention, and the chairperson, Dr. Lynn Drake, subsequently promised to withdraw from the event. In this follow-up letter to Hamburg, Wolfe highlights conflicting statements made to the press by the FDA, Drake, and the conference organizer. The contradictory nature of the statements illuminates the urgent need for a written policy to address inadequate ethics training of FDA advisory committee members.
[Created on 10/30/2013]

Letter to FDA Commissioner Hamburg on FDA Advisory Committee Chair Participation in Pharmaceutical Industry Conference (HRG Publication #2166)
In a letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg, Public Citizen’s Dr. Sidney Wolfe raises concerns regarding the participation of an FDA Advisory Committee chairperson in a pharmaceutical industry conference. In her conference presentation, the chairperson will be advising industry employees on ways to improve the likelihood of a drug’s receiving FDA approval. Such pro-industry activity on the part of an advisory committee representative could undermine public confidence both in FDA advisory committees and in the agency itself.
[Created on 10/24/2013]

Letter to HHS Secretary and Assistant Secretary for Health Criticizing Revised Policy on Remuneration of Human Research Subjects (HRG Publication #2165)
The sudden removal of a key clause from a Department of Health and Human Services guidance document issued by the Office for Human Research Protections could lead to human subjects of research being pressured to take on greater risks that they would not otherwise have accepted because they could now be offered greater remuneration in exchange for accepting risk. This change undermines protections for human subjects, increases the potential for exploitation, and should have been subject to public input before being implemented.
[Created on 10/23/2013]

Testimony to the FDA’s Circulatory System Devices Panel on the Premarket Approval (PMA) Application for the CardioMEMS Champion HF Monitoring System (HRG Publication #2164)
Public Citizen urges the Food and Drug Administration to not approve the CardioMEMS System for monitoring heart failure patients. There is insufficient evidence that the device is effective or that the benefits of its use outweigh the risks related to its implantation.
[Created on 10/9/2013]

Public Citizen Supports European Policy on Publication of Clinical Trials Data (HRG Publication #2163)
Public Citizen writes to the European Medicines Agency (EMA), the European Union agency that carries out premarket approval for drugs, to support the EMA’s proposed policy that would provide for the publication of clinical-trial data submitted to the EMA in the future. This policy will enable independent expert groups to review the benefits of and risks of EMA-approved drugs, which are often also approved for marketing in the United States. The proposed policy will promote transparency and the opportunity for independent review, two cornerstones of sound medical research and good regulatory decision-making, while will adequately protecting patient privacy.
[Created on 9/30/2013]

Statement: An Inexcusable Delay: FDA Finally Approves Black Box Warning for Antibiotic Tygacil, as Called for by Public Citizen (HRG Publication #2162)
Public Citizen welcomes the announcement by the Food and Drug Administration (FDA) that the agency has approved a new black box warning for the antibiotic tigecycline (brand name: Tygacil). The warning indicates that clinical trials have found an increased risk of death with tigecycline in comparison to other antibiotics and that the drug should thus be used only when alternative treatments are not suitable. Public Citizen first requested this warning in a November 2011 citizen petition to the FDA.
[Created on 9/27/2013]

Statement: Proposed Compromise Compounding Bill Threatens Patient Safety by Allowing ‘Outsourcing Facilities’ to Manufacture Drugs Without New Drug Approval (HRG Publication #2161)
A year after a deadly disease outbreak linked to tainted compounded drugs, a newly proposed Congressional bill would make it easier for companies like the one behind the outbreak to manufacture substandard drugs without Food and Drug Administration approval, under the guise of pharmacy compounding.
[Created on 9/27/2013]

Statement: FDA’s Unique Device Identifier Rule Years Delayed but a Welcome Step Forward for Medical Device Safety (HRG Publication #2160)
Public Citizen applauds the long-overdue announcement by the Food and Drug Administration (FDA) that it will soon require a unique device identifier (UDI) system for medical devices. The system will improve the tracking and analysis of adverse events related to medical devices. It also will facilitate more efficient, effective and complete implementation of device-related recalls. Public Citizen has strongly advocated for a UDI system as a key step toward improving the safety of medical devices.
[Created on 9/20/2013]

Public Citizen Opposes Reclassification of Extracorporeal Membrane Oxygenation (ECMO) Devices (HRG Publication #2159)
Public Citizen testified before the FDA’s Circulatory System Devices Panel opposing the reclassification of ECMO devices from Class III to Class II for conditions in which imminent death is threatened by cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery in pediatric patients. The FDA should instead publish a proposed final rule maintaining the devices’ Class III classification for all indications and set an effective date requiring the submission of evidence that the device is safe and effective for all current uses.
[Created on 9/12/2013]

Statement: FDA Action Benefits Industry, Perpetuates Unsafe Use of Opioid Pain Medications (HRG Publication #2158)
The Food and Drug Administration (FDA) recently announced new safety requirements for certain opioid pain medications. The action represents a small step in the right direction, but it ultimately fails to adequately ensure the safety of chronic pain patients, and it favors the interests of the pharmaceutical industry over those of the public’s health.
[Created on 9/11/2013]

Public Citizen Opposes Reclassification of External Cardiac Compressor Devices (HRG Publication #2157)
Public Citizen testified before the FDA’s Circulatory System Devices Panel opposing the reclassification of External Cardiac Compressor (ECC) devices from Class III, requiring premarket approval, to Class I or II, which do not require premarket approval. The best-designed study of these devices, the ASPIRE study, provided strong evidence that death and neurological injury are more common with use of this device compared to manual CPR. Public Citizen recommends that FDA require that these devices be approved through the FDA’s premarket approval process because more testing is needed to show that the devices are safe and effective.
[Created on 9/11/2013]

Testimony before the FDA’s Pulmonary and Allergy Drugs Advisory Committee on umeclidinium/vilanterol (proposed trade name Anoro Ellipta) for the long-term treatment of patients with chronic obstructive pulmonary disease (COPD) (HRG Publication #2156)
Public Citizen opposes the approval of the combination therapy umeclidinium/vilanterol (proposed trade name Anoro Ellipta) for the treatment of COPD because the drug led to a higher rate of abnormal heart rhythms and non-fatal heart attacks in the pre-approval clinical trials.
[Created on 9/10/2013]

Letter to HHS Secretary Regarding Impact of Oregon Law on National National Practitioner Data Bank (HRG Publication #2155)
Public Citizen is writing to express serious concern that a law recently enacted by the state of Oregon threatens the viability of the National Practitioner Data Bank as a comprehensive and reliable source of data regarding malpractice payouts, particularly if other states follow Oregon’s lead. The Oregon law seeks to create a loophole that would allow physicians to avoid reporting to the Data Bank any malpractice payments that are negotiated through a mediation process specified under the new law.
[Created on 9/10/2013]

Testimony Before the FDA Pediatric Ethics Subcommittee of the Pediatric Advisory Committee (HRG Publication #2154)
Pre-event clinical trials in children testing greater-than-minimal-risk experimental medical countermeasures against unlikely exposures to various biologic or chemical agents, such as the proposed clinical trial involving exposure of children to the anthrax vaccine, are unethical and should not be permitted by the Food and Drug Administration or the Department of Health and Human Services.
[Created on 9/9/2013]

Comments to HHS Responding to Questions About Informed Consent for Human Subjects Research (HRG Publication #2153)
Public Citizen responds to the request for comments on the protection of human research subjects, as well as research studying “standard of care” interventions. These written comments supplement the testimony we provided at the August 28 public meeting convened by the Department of Health and Human Services (HHS).
[Created on 9/6/2013]

Testimony before HHS Panel on Informed Consent for Human Subjects Research (HRG Publication #2152)
In light of recent, high profile instances of serious ethical breaches involving infants, Public Citizen Health Research Group Director Michael Carome and Health Research Group Founder Sidney Wolfe testify before the Department of Health and Human Services regarding “standard of care” interventions in human subjects.
[Created on 8/28/2013]

Press Release: In Wake of Controversy Over Unethical NIH-Funded Premature Baby Trial, HHS Seeks Way Forward (HRG Publication #2151)

Publicity over an unethical NIH-funded trial conducted on premature infants has sparked an unusual Aug. 28 public forum at the Department of Health and Human Services (HHS), designed to solicit comments from experts and the public about what risks should be disclosed to participants when research is focused on standard-of-care treatment. The outcome of the HHS public meeting could weaken rules for protecting human research subjects.

[Created on 8/21/2013]

Letter to HHS Secretary Sebelius on a New NIH-Funded Premature Infant Study Lacking Compliance with Ethical Consent Standards (HRG Publication #2150)
Only months after exposing an unethical, federally funded experiment conducted on premature infants, Public Citizen has learned of a similar trial also posing known risks to premature babies without fully informing the parents about those risks. In a letter to Health and Human Services (HHS) Secretary Sebelius, Public Citizen urges that recruitment for the trial, which started only recently, be halted, and that the parents of babies already enrolled in the study be contacted regarding the consent-form deficiencies.
[Created on 8/22/2013]

Public Citizen Petition to FDA to Warn Against Prolonged Use of Clopidogrel (Plavix) in Cardiac-Stent Patients Because of Lethal Side Effects, No Benefit (HRG Publication #2149)
Public Citizen petitions the Food and Drug Administration to warn patients and doctors that taking the widely prescribed drug clopidogrel (brand name: Plavix) for more than a year after having a drug-eluting stent implanted can lead to potentially fatal bleeding without providing further benefits.
[Created on 8/21/2013]

Letter to HHS Secretary Sebelius Regarding Specialty Compounding (HRG Publication #2148)
Public Citizen urges Secretary of Health and Human Services Kathleen Sebelius to direct the Food and Drug Administration (FDA) to seek an injunction against Specialty Compounding, a Texas compounding pharmacy cited by FDA inspectors for multiple sterility concerns in March 2013. We also urge that the Inspector General conduct an investigation to determine why the FDA did not request an earlier voluntary recall, issue a public safety alert, or seek an injunction after inspectors noted the serious quality control problems. Further actions should be initiated against all pharmacies with quality control problems similar to those of Specialty Compounding. Since fall of 2012, “significant objectionable conditions” have been identified at 50 compounding pharmacy facilities, yet only 16 of these facilities have initiated a product recall or been the subject of an FDA enforcement action.
[Created on 8/14/2013]

Public Citizen Opposes Approval of Drug with Liver Toxicity Risks at FDA Advisory Committee Meeting (HRG Publication #2147)
In testimony before the Food and Drug Administration, Public Citizen spoke against approval of the drug tolvaptan for use in polycystic kidney disease, citing its liver toxicity risks and that it does not meet essential elements of efficacy needed for drug approval.
[Created on 8/5/2013]

Letter to the FDA Regarding Use of Experimental Pulse Oximeter Devices in the SUPPORT Study (HRG Publication #2146)
Public Citizen previously sent letters to Secretary of Health and Human Services Kathleen Sebelius raising serious concerns about the neonatal SUPPORT study. These letters highlighted important omissions, as well as misleading statements regarding the nature and risks of the research, in the consent forms used in the study. We now pose questions regarding the intentionally miscalibrated pulse oximeter devices used to measure the blood oxygen levels of the premature infants in the SUPPORT Study.
[Created on 8/2/2013]

Press Release: Patients Should Beware When New Drug for Overactive Bladder Soon Becomes Available Over-the-Counter (HRG Publication #2145)
The latest edition of Worst Pills, Best Pills News, Public Citizen’s drug safety newsletter and website, advises that when a new version of oxybutynin (Oxytrol for Women) for overactive bladder becomes available without a prescription in the fall, people should avoid it if they haven’t first talked with their doctor.
[Created on 8/1/2013]

Public Citizen Criticizes Dangerous, Flawed FDA Risk-Mitigation Program, Citing Examples of Five Drugs (HRG Publication #2144)
In testimony before the Food and Drug Administration (FDA), Public Citizen criticizes the agency’s Risk Evaluation and Mitigation Strategies (REMS) program, citing several areas of failure of the program and noting five drugs that exemplify these failures.
[Created on 7/26/2013]

Letter to CMS Supporting Proposed Decision to Severely Restrict Coverage for β-Amyloid PET Imaging in Dementia (HRG Publication #2143)
Public Citizen strongly supports the Centers for Medicare & Medicaid Services’ (CMS’s) proposed decision to only cover positron emission tomography (PET) amyloid-beta (Aβ) imaging in dementia and neurodegenerative disease for a limited set of circumstances. There is insufficient clinical-trial data to support that this technology changes the health outcomes of patients who display early symptoms or signs of cognitive dysfunction, or in any other patient population.
[Created on 7/23/2013]

Public Citizen Comments for House Regarding Compounding Pharmacy Legislation (HRG Publication #2142)
Public Citizen expresses our grave concerns with all three pending pieces of legislation on pharmacy compounding. There may be significant differences between these three proposals, but all of them put patients at risk by permitting compounding pharmacies to engage in drug manufacturing activity without seeking a new drug approval from the Food and Drug Administration (FDA) or complying with important federal drug labeling requirements.
[Created on 7/15/2013]

Testimony to the FDA Drug Safety and Risk Management Advisory Committee on the Restrictions on the Use of Lotronex (HRG Publication #2141)
Public Citizen recommends that restrictions on Lotronex (alosetron) be tightened, rather than loosened, due to its high risk of life-threatening adverse reactions compared with its marginal benefits.
[Created on 7/10/2013]

Statement: FDA Proposal to Revise Drug Labeling Regulations Is Welcome News, Will Improve Drug Safety (HRG Publication #2140)
Public Citizen is extremely pleased to see that the Food and Drug Administration sent to the Office of Management and Budget a proposed rule to revise FDA regulations about prescription drug labeling. When finalized, the revisions will fill a regulatory gap related to generic drug labeling that poses a risk to patient safety.
[Created on 7/3/2013]

Public Citizen comments on regulatory classification of automated external defibrillator (AED) devices (HRG Publication #2139)
Public Citizen supports the Food and Drug Administration’s (FDA’s) proposed order requiring premarket approval applications for automated external defibrillator (AED) devices. Public Citizen’s Health Research Group previously offered testimony before the FDA Panel on Circulatory System Devices of the Medical Devices Advisory Committee on January 25, 2011, urging the panel to recommend that AED devices remain in Class III and be reviewed through the premarket approval (PMA) process, a recommendation that the panel ultimately adopted.
[Created on 6/24/2013]

Generic Drug Labeling: A Report on Serious Warnings Added to Approved Drugs and on Generic Drugs Marketed Without a Brand-Name Equivalent (HRG Publication #2138)
Today, the majority of prescriptions filled in the United States are filled with generic drugs, making prescription drugs more affordable for patients. Many potential hazards are not discovered until years after drugs have been on the market, yet under current FDA regulations, generic drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk. In this report, Public Citizen lists 53 drugs approved by the Food and Drug Administration more than 10 years ago that have required new black-box warnings over the past five years and also provides a list of more than 400 drugs for which the brand-name product is no longer sold.
[Created on 6/20/2013]

Public Citizen Comments on Draft Revision of the Declaration of Helsinki (HRG Publication #2137)
Public Citizen supports many of the proposed revisions to the World Health Organization’s Declaration of Helsinki. However, Public Citizen expresses concern regarding one important statement — “the well-being of the individual research subject must take precedence over all other interests” — being characterized as “intended to be aspirational.” Such a comment undermines the value of this specific statement and the force of the entire document as a guide for physicians engaged in medical research.
[Created on 6/14/2013]

Letter to the FDA Opposing Approval of the Sleep Medicine Suvorexant (HRG Publication #2136)
This letter was sent to the U.S. Food and Drug Administration (FDA) as a follow-up to our testimony at the May 22, 2013 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee that voted in favor of approval of the dangerous sleep medicine, suvorexant. We again urge the FDA not to approve suvorexant because the drug’s long-lasting risks – both to patients and the general public – outweigh any short-term benefits on sleep.
[Created on 6/14/2013]

Letter to HHS Secretary Sebelius Regarding the SUPPORT Study and Censorship of an NIH Expert (HRG Publication #2135)
Public Citizen informed Health and Human Services Secretary Sebelius that it is deeply troubled to learn that NIH has silenced an expert within the agency who has previously raised serious concerns about the ethics of clinical trials with designs that are very similar, if not identical, to that of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT study) involving extremely premature babies.
[Created on 6/13/2013]

Testimony to FDA Drug Safety and Risk Management and Endocrine and Metabolic Drugs Advisory Committees Regarding Rosiglitazone Safety (HRG Publication #2134)
Public Citizen argues that not only should the current restrictions on the use of the diabetes drug rosiglitazone (Avandia) not be lifted, the drug should be removed from the U.S. market given its unique risks and the absence of any unique benefits. Among older patients with diabetes, rosiglitazone is associated with a significantly higher risk of heart failure and death compared to pioglitazone.
[Created on 6/6/2013]

Statement: The Office for Human Research Protections Reaffirms Main Findings of Inadequate Informed Consent for Premature Baby Study, But Bows to Political Pressure and Puts Enforcement Actions on Hold (HRG Publication #2133)
The federal government has taken an important step toward addressing a highly unethical trial involving premature babies but still is leaving infants and other subjects at risk by permitting current similar trials to continue.
[Created on 6/5/2013]

Problems with Office of Inspector General Exclusion Reports Undermine the Usefulness of the National Practitioner Data Bank (HRG Publication #2132)
Public Citizen issued a report finding that Because of problems with the reports provided to the National Practitioner Data Bank by the Office of Inspector General at the U.S. Department of Health and Human Services, entities using the data bank to conduct background checks may not learn that health care providers have been excluded from Medicare or Medicaid for such things as substandard services and fraud.
[Created on 6/4/2013]

Statement: Stepping Aside But Not Out: Well-Known Consumer Health Advocate Dr. Sidney Wolfe Hands Over Reins to Deputy (HRG Publication #2131)
After leading Public Citizen’s Health Research Group for more than 40 years through everything from pitched battles against the pharmaceutical industry to groundbreaking research on dangerous doctors, Dr. Sidney Wolfe, founder and longtime director of the program, is handing over leadership of it to his deputy today.
[Created on 6/3/2013]

Statement: Immigrants Deserve Better Health Coverage (HRG Publication #2130)
A Harvard University/City University of New York Health Affairs study published today shows that although immigrants contributed about $115.2 billion more to the Medicare Trust Fund than they took out between 2002 and 2009, one out of three were uninsured.
[Created on 5/29/2013]

Testimony to the FDA Peripheral and Central Nervous Systems Drugs Advisory Committee on Suvorexant (HRG Publication #2129)
The U.S. Food and Drug Administration should not approve the latest sleep medicine suvorexant because the drug’s long-lasting risks – both to patients and the general public – outweigh any short-term benefits on sleep.
[Created on 5/22/2013]

Public Citizen Commentary on the SUPPORT Study Involving Premature Babies (HRG Publication #2128)
In a commentary published by The Hastings Center on-line Bioethics Forum, Public Citizen responded to another recent commentary written by a pediatric bioethicist attacking our position that that the conduct of the SUPPORT study involving premature babies was unethical because parents of babies enrolled in the study were not informed of the purpose, nature, and risks of the research.
[Created on 5/21/2013]

Public Citizen to Congress: New Bill on Pharmacy Compounding a Major Step Backward for U.S. Drug Safety (HRG Publication #2127)
On May 3, 2013, Public Citizen expressed grave concerns to the Senate Health, Education, Labor & Pensions (HELP) Committee that its draft proposal on pharmacy compounding would weaken existing laws governing drug manufacturing. The proposal would create a new regulatory class of drug manufacturers, confusingly called “compounding manufacturers,” that would be exempt from federal premarket approval and related labeling requirements. The bill on pharmacy compounding, S. 959, introduced in the Senate on May 15, offers no significant improvement over the draft. The American public deserves much better.
[Created on 5/16/2013]

Letter to the Editor of The Washington Post Criticizing a Recent Editorial Lauding U.S. Senate Legislation on Compounding Pharmacies (HRG Publication #2126)
In a letter to the editor of The Washington Post, Public Citizen strongly criticized the May 6 editorial “Concocting a cure” supporting draft U.S. Senate legislation on pharmacy compounding. The bill would be a significant step backward for drug safety in the U.S.
[Created on 5/12/2013]

Public Citizen Petitions the Consumer Product Safety Commission to Ban Adult Portable Bedrails due to Strangulation Risks (HRG Publication #2125)
Public Citizen sent a petition today to the Consumer Product Safety Commission (CPSC) asking for a ban on adult portable bedrails. Portable rails are designed to slip under an ordinary mattress and are advertised as making beds “safer” for seniors who have trouble getting in and out of bed unassisted. The CPSC reported in 2012 that bed rails have been associated with at least 155 fatalities, mostly from strangulation incidents where an elderly victim became stuck, wedged, or trapped between the mattress and bed rail. There is also no evidence that bedrails actually help prevent falls. Public Citizen has asked the CPSC to ban adult portable bedrails because the product cannot be re-designed to eliminate the strangulation risk.
[Created on 5/9/2013]

Public Citizen Report Documents Lack of Informed Consent for Risky Study on Premature Babies (HRG Publication #2124)
In a report submitted to Secretary of Health and Human Services Kathleen Sebelius, Public Citizen presents an independent analysis of the complete protocol and informed consent documents for the SUPPORT study, which involved extremely premature babies. The key finding in the report is that parents of babies enrolled in the study were not told the dangers of the study’s experimental procedures.
[Created on 5/8/2013]

Letter to the Council of the District of Columbia Supporting Passage of the Patient Protection Act (HRG Publication #2123)
Public Citizen President Robert Weissman and Deputy Director of Health Research Group Michael Carome praise the DC City Council for introducing the Patient Protection Act. They urge the Council to pass the legislation, which would combat the ill effects of hospital understaffing on patient health and help avoid preventable hospital readmissions.
[Created on 5/6/2013]

Comments on Sorbent Hemoperfusion, Cranial Electrotherapy Stimulators, and Transilluminators for Breast Evaluation (HRG Publication #2122)
Public Citizen opposes the FDA’s proposed order reclassifying sorbent hemoperfusion devices into Class II for the treatment of poisoning and drug overdose, based on concerns that the devices carry severe, life-threatening risks, and insufficient clinical evidence exists to determine whether they are effective compared with alternatives. We support the FDA’s proposal to retain these devices in Class III (requiring premarket approval) for the treatment of hepatic coma and metabolic disturbances. We also support the FDA’s proposal to retain cranial electrotherapy stimulators and transilluminators for breast evaluation in Class III, as safety and efficacy for these devices has also not been established.
[Created on 5/6/2013]

Public Citizen’s Comments on Senate HELP Committee Draft Proposal for Regulatory Oversight of Compounding Pharmacies (HRG Publication #2121)
Public Citizen expresses grave concerns with the Committee’s draft legislative proposal which will weaken existing laws governing drug manufacturing by creating an entirely new regulatory class of drug manufacturers that would be subject to substandard requirements for ensuring the efficacy, safety, quality, and labeling of drugs.
[Created on 5/3/2013]

Statement to Congress: Proposed Compounding Pharmacy Legislation Would Be a Major Step Backward for U.S. Drug Safety (HRG Publication #2120)
Draft legislation on pharmacy compounding released by the U.S. Senate Committee on Health, Education, Labor, and Pensions would dramatically weaken patient protections by creating an extremely dangerous new class of drug manufacturers, confusingly called “compounding manufacturers.” These second-tier manufacturers would be permitted to mass-produce standardized drugs without obtaining FDA approval or meeting federal labeling requirements intended to ensure the safe use of drugs.
[Created on 5/1/2013]

Letter to FDA Opposing Approval of Fluticasone Furoate/Vilanterol (FF/VI) for COPD (HRG Publication #2119)
These comments are being submitted in follow-up to Public Citizen’s testimony presented at the April 17, 2013, meeting of the FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) opposing approval of the combination drug fluticasone furoate/vilanterol (FF/VI; proposed trade name Breo Ellipta). This combination offers no clinically meaningful benefit but clearly causes increased risks compared with the bronchodilator vilanterol alone. In addition, two of the four pivotal trials upon which this new drug application is based were unethical, withholding critical, long-acting bronchodilator therapy from patients in the placebo and inhaled corticosteroid arms.
[Created on 4/30/2013]

Comments to the Docket for FDA Proposed Guidance for Industry on Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease (HRG Publication #2118)
Public Citizen submits comments on the FDA’s proposed industry guidance for Treatment of Early Stage Alzheimer’s Disease, including its absence of discussion of the effectiveness of physical and mental exercise and a critique of the Guidance itself because it lacks a scientific basis for either accurately diagnosing or measuring the effects of treatment on people with such early disease.
[Created on 4/25/2013]

Letter to FDA Demanding Explanation for Dangerous Delay Between Identifying Problems and Public Recall of Potentially Contaminated Products Distributed by Balanced Solutions Compounding Pharmacy (HRG Publication #2117)
Public Citizen requests an explanation for the unacceptable one-month delay between the Food and Drug Administration’s (FDA’s) inspection of Axium Healthcare Pharmacy (dba Balanced Solutions Compounding Pharmacy), which was finished on March 15, 2013 and identified serious quality control problems related to the production of sterile drugs, and the subsequent nationwide voluntary recall of all lots of sterile products compounded by this pharmacy on April 17, 2013.
[Created on 4/22/2013]

Letter to the Editor of The Washington Post Criticizing FDA for its Failure to Regulate Drug Manufacturing by Compounding Pharmacies (HRG Publication #2116)
In a letter to the editor of The Washington Post, Public Citizen responded to the April 12 front-page article “FDA finds safety problems at specialized pharmacies.” The Food and Drug Administration must ensure that companies that engage in drug manufacturing under the guise of pharmacy compounding either scale down their operations or adhere to current federal regulations governing drug manufacturing.
[Created on 4/21/2013]

Letter to the Assistant Secretary for Health and the OHRP Director Regarding Neonatal Research Network Trials (HRG Publication #2115)
Public Citizen requests emergency action by the Office for Human Research Protections (OHRP) to ensure that newborn premature and term infants are being adequately protected in seven current randomized trials being conducted by the Neonatal Research Network (NRN).
[Created on 4/18/2013]

Testimony on Fluticasone/Vilanterol Combination Therapy to the FDA’s Pulmonary-Allergy Drugs Advisory Committee (HRG Publication #2114)
The Food and Drug Administration (FDA) should not approve the proposed combination therapy, fluticasone/vilanterol (proposed trade name: Breo Ellipta) for the treatment of chronic obstructive pulmonary disease (COPD), because the drug is largely ineffective and causes serious side effects compared with vilanterol given alone, and was studied in a series of unethical clinical trials.
[Created on 4/17/2013]

Letter to Secretary of Health and Human Services Regarding Ongoing Clinical Trials Conducted by the Neonatal Research Network (HRG Publication #2113)
In a letter to Health and Human Services Secretary Kathleen Sebelius, Public Citizen demanded that, in light of disturbing revelations about the unethical SUPPORT study involving premature babies, the Department of Human Health and Services should release details about ongoing clinical trials involving infants conducted by the Neonatal Research Network and suspend enrollment in them until they are independently assessed by ethicists and others.
[Created on 4/15/2013]

Letter to Dr. Richard Marchase at the University of Alabama at Birmingham Criticizing His Misleading Statements to the Media Regarding the Unethical SUPPORT Study (HRG Publication #2112)
Public Citizen sent a letter to Dr. Richard Marchase, Vice President for Research & Economic Development at the University of Alabama at Birmingham criticizing him for making statement to the media that have misled reporters just as the egregious deficiencies in the consent forms misled the parents of the premature babies enrolled in the SUPPORT study with regard to the purpose, nature, and risks of the research.
[Created on 4/11/2013]

Letter to Secretary of Health and Human Services Regarding Unethical Trial Involving Premature Infants (HRG Publication #2111)
In a letter to Health and Human Services Secretary Kathleen Sebelius, Public Citizen urged the secretary to personally apologize to the parents of 1,316 premature infants who were exposed to an increased risk of blindness and death as part of a clinical trial funded by the National Institutes of Health and held throughout the U.S. several years ago – because their parents were not informed about the risks or true nature and purpose of the research.
[Created on 4/10/2013]

Comments Submitted to the FDA Regarding Extracorporeal Membrane Oxygenation (ECMO) Devices (HRG Publication #2110)
Public Citizen urges the FDA to withdraw its proposal for Class II reclassification of ECMO devices for conditions in which imminent death is threatened by cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery. The FDA should instead publish a proposed final rule maintaining the devices’ Class III classification for all indications and set an effective date requiring the submission of evidence that the device is safe and effective for all current uses.
[Created on 4/8/2013]

Comments Submitted to the FDA Regarding Automated External Cardiac Compressor Devices (HRG Publication #2109)
Public Citizen urges the FDA to withdraw its proposal for Class II reclassification of automatic external cardiac compressor devices for chest compressions during cardiopulmonary resuscitation (CPR) because there is a lack of evidence that they are safe and effective. The FDA should instead publish a proposed final rule maintaining the devices’ Class III designation and set an effective date requiring the submission of evidence that the devices are safe and effective.
[Created on 4/8/2013]

Follow-up Letter to the Texas Medical Board Regarding the LipoTron Device (HRG Publication #2108)
Public Citizen has previously brought to the attention of the Texas Medical Board the apparent illegal distribution, sale, and promotion of the LipoTron medical device by a list of Texas Physicians. We now emphasize the fact that the FDA recently issued a warning to the makers of the LipoTron device that it is considered by the agency to be both adulterated and misbranded.
[Created on 3/25/2013]

Press Release: New Study Underscores Increased Dangers of Certain Diabetes Treatments (HRG Publication #2107)
New scientific evidence published today reveals an association between the development of precancerous lesions in the pancreas and use of a class of diabetes drugs known as incretins, which include Byetta (exenatide), Victoza (liraglutide) and Januvia (sitagliptin). These new findings are in accord with the rapidly increasing number of reports to the Food and Drug Administration of pancreatic cancer in patients using these drugs compared with diabetics using other drugs for diabetes.
[Created on 3/22/2013]

Letter to CMS Opposing Medicare Coverage for β-Amyloid PET Imaging in Dementia (HRG Publication #2106)
Public Citizen urges the Centers for Medicare & Medicaid Services (CMS) to maintain its current exclusion of coverage for β-amyloid positron emission tomography (PET) imaging in dementia and neurodegenerative disease because there is a lack of adequate evidence to determine whether such imaging changes the health outcomes of any patient population.
[Created on 3/21/2013]

Testimony Before FDA’s Circulatory System Devices Panel Regarding the Abbott Vascular MitraClip Clip Delivery System (HRG Publication #2105)
Public Citizen’s Health Research Group strongly opposes the Food and Drug Administration’s (FDA) approval of the MitraClip Clip Delivery System (MitraClip) in high-risk patients due to a lack of evidence that the device’s benefits outweigh its risks, not limited to bleeding, cardiac arrest, and death.
[Created on 3/20/2013]

Press Release: Good Move, But Years Late: FDA Warns Maker of ‘Fat-Burning’ Device to Stop Marketing Unapproved Product (HRG Publication #2104)
The Food and Drug Administration (FDA) is doing the right thing by warning RevecoMED International, the maker of the LipoTron “fat-burning” device, to stop marketing the device, which has not been FDA-approved for “fat-burning.” However, the action comes years too late.
[Created on 3/19/2013]

Comments Submitted to the FDA’s Drug Shortages Task Force (HRG Publication #2103)
Strengthened enforcement over compounding pharmacies who are acting as drug manufacturers would help to alleviate drug shortages by creating incentives for mainstream drug manufacturers to produce high-quality, Food and Drug Administration-approved medication.
[Created on 3/14/2013]

Petition to FDA from Eight Public Health and Consumer Advocacy Organizations to Expand Monitoring of Tobacco Products (HRG Publication #2102)
Public Citizen and seven other organizations call upon the FDA to implement a tracking system on tobacco products so that the agency may fulfill its obligations under the Federal Food, Drug, and Cosmetic Act and help prevent illegal activity, such as tobacco product smuggling and trafficking.
[Created on 3/8/2013]

Testimony to the FDA’s Advisory Committee on Reproductive Health Drugs on Nasal Calcitonin for Osteoporosis (HRG Publication #2101)
Calcitonin nasal spray, prescribed to treat osteoporosis since 1994, should be removed from the market because is not very effective for preventing fractures and may cause cancer and other serious side effects.
[Created on 3/5/2013]

Testimony to the FDA’s Advisory Committee on Reproductive Health Drugs on paroxetine for menopausal symptoms (HRG Publication #2100)
Public Citizen strongly opposes the Food and Drug Administration’s (FDA’s) approval of paroxetine for treatment of menopause-related vasomotor symptoms (VMS, which includes hot flashes and flushing) due to the drug’s questionable benefits and well-established risks.
[Created on 3/4/2013]

Testimony to the FDA’s Advisory Committee on Reproductive Health Drugs on gabapentin for menopausal symptoms (HRG Publication #2099)
Public Citizen strongly opposes the Food and Drug Administration’s (FDA’s) approval of gabapentin for treatment of menopause-related vasomotor symptoms (VMS, which includes hot flashes and flushing) due to the drug’s questionable benefits and well-established risks.
[Created on 3/4/2013]

Letter to OHRP Alleging Inadequate Informed Consent for Study Involving Diabetic Children (HRG Publication #2098)
Public Citizen, for the third time, calls upon the Office for Human Research Protections (OHRP) to investigate all institutions engaged in a risky NIH-funded research study involving diabetic children because the risks, benefits and nature of the research was not adequately described to the subjects and the parents of child subjects.
[Created on 2/27/2013]

Keynote Address by Sidney Wolfe, MD at “Selling Sickness” Conference (HRG Publication #2097)
Public Citizen’s presentation to the “Selling Sickness” conference regarding the drug companies’ strategy of promoting dangerous products to treat routine ailments and the FDA’s collusion in this practice.
[Created on 2/21/2013]

Letter to the Executive Director of the European Medicines Agency on Bedaquiline (HRG Publication #2096)
Public Citizen urges the European Medicines Agency not to approve the new tuberculosis drug bedaquiline, which in clinical tests has shown significantly higher mortality rates.
[Created on 2/13/2013]

Letter to Department of Health and Human Services Regarding the Chronic Fatigue Syndrome Advisory Committee (HRG Publication #2095)
Public Citizen has been alerted that important transparency requirements for federal advisory committees are being ignored by the HHS advisory committee on chronic fatigue syndrome.
[Created on 2/14/2013]

Letter to FDA on IABP Regulatory Classification (HRG Publication #2094)
Public Citizen strongly urges the Food and Drug Administration (FDA) to withdraw its proposal to reclassify the intra-aortic balloon pump pre-amendment Class III device to Class II (special controls) for three common indications and to publish a notice immediately that proposes a final regulation requiring the device to remain in Class III for all indications, and require pre-market approval applications for new intra-aortic balloon pumps.
[Created on 2/13/2013]

Letter to the FDA Criticizing the Decision to Keep the Wingspan Stent System on the Market (HRG Publication #2093)
Public Citizen sent a letter to the FDA today criticizing the agency’s August 2012 decision to keep a dangerous brain stent, the Wingspan Stent System, on the market after a high-quality clinical trial showed that the device causes death and stroke. The FDA acknowledged in August that the stent was dangerous for most patients, but chose to approve the device for a limited group of patients rather than ban the device outright. Public Citizen condemns the FDA for making the decision without evidence that the device would be any less dangerous for those people in the limited patient group than it is for most patients, and for failing to adequately warn doctors and patients of the deadly risks.
[Created on 1/28/2013]

Testimony to Drug Safety and Risk Management Advisory Committee on Overprescription of Hydrocodone (HRG Publication #2092)
Ninety-nine percent of the hydrocodone in the world is manufactured and used in the United States – evidence that hydrocodone products are being overprescribed and should be severely restricted, Public Citizen told the FDA today.
[Created on 1/25/2013]

Testimony on Canagliflozin to the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (HRG Publication #2091)
Public Citizen opposes the FDA’s approval of the new diabetes drug canagliflozin because it demonstrates no evidence of any improved clinical outcomes while creating increased risks of dangerous side-effects, including cardiovascular events.
[Created on 1/10/2013]

Letter to the Secretary of Health and Human Services Criticizing Recent Action Taken by the Office for Human Research Protections (HRG Publication #2090)
Public Citizen expresses serious concern with the recent dangerously lax compliance oversight determinations made by the Office for Human Research Protections (OHRP) — a program office within the Office of the Secretary of Health and Human Services — that, unless overturned, will seriously undermine the regulatory protections for children provided under the Department of Health and Human Services (HHS) human-subjects protection regulations.
[Created on 1/9/2013]

2012

Testimony of Sidney Wolfe at FDA Hearing on Ampligen (HRG Publication #2089)
Public Citizen presented evidence from a study on Ampligen that failed to show that the drug was safe or effective for the treatment of Chronic Fatigue Syndrome.
[Created on 12/20/2012]

Letter to FDA Opposing Approval of Bedaquiline (HRG Publication #2088)
Public Citizen strongly opposes the accelerated approval of bedaquiline because patients taking the drug, in addition to standard TB treatment, during a phase 2 clinical trial were five times likelier to die than those who took a placebo.
[Created on 12/21/2012]

Letter to HHS Secretary Regarding the FDA Commissioner’s Congressional Testimony on Compounded Drugs (HRG Publication #2087)
Description: Public Citizen criticized FDA Commissioner Margaret Hamburg for both undermining her agency’s authority in congressional testimony last month and offering a plan that would effectively weaken the agency’s oversight of drug manufacturing.
[Created on 12/18/2012]

Comments to Senate Committee on Health, Education, Labor, and Pensions on the FDA’s Flawed Proposal for Oversight of Compounding Pharmacies (HRG Publication #2086)
In response to the recent fungal meningitis outbreak, the FDA proposed a new regulatory framework for compounding pharmacies that would weaken, rather than strengthen, existing laws governing drug manufacturing. Public Citizen believes it wiser to strengthen existing laws by clarifying the line between traditional pharmacy compounding and drug manufacturing and clarifying the federal standards governing traditional compounding. All drug manufactures must be held to the same rigorous safety and quality standards.
[Created on 11/30/2012]

Letter to the FDA Urging Re-Inspection of Compounding Pharmacies with Serious Safety Violations (HRG Publication #2085)
The dangers of unregulated compounding pharmacies have been made tragically clear in the wake of the recent fungal meningitis outbreak. Public Citizen urges the Food and Drug Administration to promptly re-inspect each of the 16 compounding pharmacy facilities where serious safety concerns were uncovered in earlier inspections and initiate a systematic program to determine whether other compounding pharmacies are engaged in illegal practices.
[Created on 11/29/2012]

Letter to the Secretary of Health and Human Services Calling for Expanded Investigation Into Deadly Meningitis Outbreak (HRG Publication #2084)
Secretary of Health and Human Services Kathleen Sebelius should appoint an independent entity – such as the Office of Inspector General – to investigate whether financial incentives created by drug compounding reimbursement policies of the Centers for Medicare and Medicaid Services (CMS) – combined with inadequate Food and Drug Administration action – fostered the recent outbreak of life-threatening fungal meningitis caused by tainted steroid injections. CMS, through its inconsistent Medicare drug reimbursement policies concerning compounded drugs and decisions allowing routine coverage for such drugs, appears to have created inadvertent financial incentives that helped large-scale production by compounding pharmacies to flourish.
[Created on 11/19/2012]

Press Release: FDA Rejects Petition to Ban Aricept 23: Did Drug Companies, FDA Collude in Approving Dangerous Alzheimer’s Drug? (HRG Publication #2083)
By rejecting Public Citizen’s petition to ban Aricept-23, the FDA has sided with Pfizer to allow a dangerous drug to remain on the market.
[Created on 11/6/2012]

Response to Senate HELP Committee’s Questions Regarding Compounding Pharmacies (HRG Publication #2082)
Public Citizen responds to the questions regarding pharmacy compounding that were posed by the Senate Committee on Health, Education, Labor, and Pensions (HELP Committee). The HELP Committee and other congressional committees responsible for overseeing the activities of the FDA should fully investigate the role this agency, as well as others, played in allowing the widespread fungal meningitis outbreak linked to contaminated injectable steroids produced by the New England Compounding Center to occur.
[Created on 11/2/2012]

Statement: FDA Still Offering Excuses and Dodging Responsibility for Its Failed Oversight that Allowed Fungal Meningitis Outbreak to Occur (HRG Publication #2081)
Public Citizen again calls on Congress and the Department of Health and Human Services’ Office of Inspector General to conduct independent investigations into the role of the FDA’s lack of oversight as a factor that contributed to the fungal meningitis outbreak.
[Created on 11/2/2012]

Letter to Secretary of Health and Human Services on FDA Oversight Failures in Light of Meningitis Outbreak (HRG Publication #2080)
Public Citizen urges the Department of Health and Human Services (HHS) to appoint an independent entity, such as the HHS Office of Inspector General, to conduct a thorough investigation into how the Food and Drug Administration failed to use its established regulatory authority to protect the public from the dangerous practice of large-scale drug compounding that lead to the widening fungal meningitis outbreak caused by tainted steroid injections.
[Created on 10/24/2012]

Testimony on Mipomersen to the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (HRG Publication #2079)
The Food and Drug Administration (FDA) should not approve the proposed cholesterol drug mipomersen because the study supporting approval was unethical and withheld an effective therapy from patients with a rare disease, while the drug itself causes a plethora of serious side effects.
[Created on 10/18/2012]

Testimony on Lomitapide to the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (HRG Publication #2078)
Public Citizen opposes the Food and Drug Administration’s approval of lomitapide because of the inadequacy of the clinical trial testing the drug and the lack of an effective risk management strategy for restricting use of the drug.
[Created on 10/17/2012]

Commentary on CNN.com: Deadly Meningitis Outbreak was Completely Avoidable (HRG Publication #2077)
In an invited commentary, Public Citizen reports that the ever-expanding outbreak of life-threatening fungal meningitis in back pain patients linked to steroid injections prepared by a compounding pharmacy, which so far has sickened at least 214 people and killed 15 in 15 states, is a public health catastrophe. What is particularly tragic for those who have been sickened or killed by the tainted drug and for their loved ones is that this situation was completely avoidable.
[Created on 10/16/2012]

Statement: Steroid-Linked Fungal Meningitis Outbreak Reveals Serious Failures in the Oversight of Compounding Pharmacies (HRG Publication #2076)
The widely publicized outbreak of life-threatening fungal meningitis in back-pain patients linked to steroid injections highlights the failure of the Food and Drug Administration’s (FDA’s) regulatory oversight of drugs prepared and sold by compounding pharmacies.
[Created on 10/9/2012]

Petition to the FDA for Black Box Warnings on ACE Inhibitors, ARBs, and Aliskiren (HRG Publication #2075)
Public Citizen petitions the Food and Drug Administration to place black box warnings on all ACE inhibitors, ARBs, and aliskiren, warning against the use of the medications in combination with one another. The drugs, given individually, are effective in treating high blood pressure, but when used in combination, cause life-threatening side effects with no added benefit.
[Created on 10/4/2012]

Letter to the the Secretary of Health and Human Services Regarding Professional Society Reporting to the National Practitioner Data Bank (HRG Publication #2074)
Public Citizen requests that the Department of Health and Human Services amend either the HHS regulations at 45 C.F.R. part 60 (National Practitioner Data Bank [NPDB] for Adverse Information on Physicians and Other Health Care Practitioners) or the department’s policy interpretation of these regulations to require the reporting to the NPDB of physicians who voluntarily resign from membership in professional societies while under formal peer-review investigation by such societies for allegations of unethical conduct.
[Created on 9/27/2012]

Pharmaceutical Industry Criminal and Civil Penalties: An Update (HRG Publication #2073)
In December 2010, Public Citizen published a report that documented the almost $20 billion paid out by the pharmaceutical industry to settle allegations of numerous violations, including illegal, off-label marketing and the deliberate overcharging of taxpayer-funded health programs, such as Medicare and Medicaid. The past two years have seen a continuation of the recent trend of record settlements between the federal and state governments and pharmaceutical manufacturers.
[Created on 9/27/2012]

Petition to the FDA to Revoke its Policy Regarding Minor Deletions from Documents Requested Under the Freedom of Information Act (HRG Publication #2072)
The Food and Drug Administration must stop its longstanding practice of redacting portions of documents released to Freedom of Information Act (FOIA) requesters without giving requesters an immediate right to appeal within the agency. The practice violates FOIA because “minor deletions” from requested documents are not considered formal denials of information requests and, therefore, do not trigger a requester’s immediate right to appeal.
[Created on 9/19/2012]

Commentary in The New York Times “Room for Debate” Series on Whether More Drugs Should be Available Over the Counter (HRG Publication #2071)
In an invited commentary as part of The New York Times “Room for Debate” series, Public Citizen argued that drugs should only be available over the counter if two commonsense criteria for ensuring patient safety are satisfied. Some classes of drugs, such as antihistamines, clearly meet these criteria and should be sold over the counter. Others, such as statin drugs, don’t.
[Created on 9/16/2012]

Letter to the Secretary of Health and Human Services Requesting an Independent Investigation of NIH’s Failure to Promptly Disclose Superbug Outbreak (HRG Publication #2070)
The Department of Health and Human Services (HHS) should open an independent investigation into the National Institutes of Health’s (NIH) handling of information related to a deadly outbreak of multi-antibiotic-resistant Klebsiella bacterial infections at the research agency’s hospital facility known as the Clinical Center, in Bethesda, MD, Public Citizen said today in a letter addressed to HHS secretary Kathleen Sebelius.
[Created on 9/10/2012]

Letter Asking the Federal Trade Commission to order Bed Handles, Inc. to Stop its Deceptive Advertising (HRG Publication #2069)
Public Citizen and the National Consumer Voice for Quality Long-Term Care request that the Federal Trade Commission (FTC) order Bed Handles, Inc., to stop its deceptive advertising of Bedside Assistant bed handles, who promotes Bedside Assistant bed handles as “[making] any bed a safer bed,” whereas, in fact, it poses an unreasonable risk of injury and has resulted in the deaths of at least four adults.
[Created on 9/6/2012]

Lawsuit to prevent dangerous Alzheimer’s treatment (HRG Publication #2068)
Public Citizen files suit to compel The Food and Drug Administration (FDA) to act on our petition calling on the agency to stop allowing the drug Aricept to be marketed at doses that can cause severe – and even fatal – side effects.
[Created on 9/5/2012]

Addressing the Response to Public Citizen’s Report Regarding Texas Medical Board Deficiencies (HRG Publication #2067)
Public Citizen responds to the letter sent by the Texas Medical Board in response to our letter and report sent August 22, 2012.
[Created on 8/28/2012]

Letter to the Presidential Commission for the Study of Bioethical Issues Opposing Unethical Anthrax Vaccine Studies in Children (HRG Publication #2066)
Public Citizen urges the Commission to recommend that the Secretary of Health and Human Services oppose the conduct of pre-event clinical trials in children of the medical countermeasures against exposures to various biologic and chemical agents, such as the pre-event clinical trials of the anthrax vaccine in children that was endorsed by the Office of the Assistant Secretary for Preparedness and Response and the National Biodefense Science Board.
[Created on 8/27/2012]

Letter to OHRP Criticizing the Agency’s Position Allowing CMS to Require Medicare Beneficiaries Undergoing Transthoracic Aortic Valve Replacement to Participate in Research (HRG Publication #2065)
In a letter to the Office for Human Research Protections, Public Citizen criticized the agency’s interpretation of the federal regulations for the protection of human subjects that allowed the Centers for Medicare and Medicaid Services to require Medicare patients to participate in research as a condition of coverage for transcatheter aortic valve replacement.
[Created on 8/27/2012]

Letter to the editor of The Washington Post criticizing NIH for its failure to alert public to an outbreak of a multi-antibiotic-resistant “superbug” (HRG Publication #2064)
In a letter to the editor of The Washington Post, Public Citizen responded to the August 23 front-page article, “Deadly bacteria stalked hospital.” NIH failed to meet its ethical obligation to inform the public about this dangerous threat to public health.
[Created on 8/27/2012]

Letter to Governor Perry Regarding Serious Deficiencies of the Texas Medical Board (HRG Publication #2063)
Public Citizen calls upon Texas Governor Rick Perry to initiate immediate action to improve the performance of the Texas Medical Board and protect patients in Texas from physicians who should have been, but were not, disciplined.
[Created on 8/22/2012]

Statement: FDA Ignores Evidence Linking Wingspan Stent System to Stroke and Death, Keeps Dangerous Device on the Market (HRG Publication #2062)
For every 11 patients treated with the Wingspan system and aggressive medical therapy, one additional patient dies or suffers a stroke within 30 days, compared to patients treated with aggressive medical therapy alone.
[Created on 8/8/2012]

Letter to the Oklahoma State Department of Health Regarding the LipoTron Device (HRG Publication #2061)
Public Citizen calls upon the Oklahoma State Department of Health to promptly investigate health spas that are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/3/2012]

Letter to the Oklahoma Board of Osteopathic Examiners Regarding the LipoTron Device (HRG Publication #2060)
Public Citizen calls upon the Oklahoma Board of Osteopathic Examiners to promptly investigate two physicians who are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/3/2012]

Letter to the Oklahoma Board of Medical Licensure and Supervision Regarding the LipoTron Device (HRG Publication #2059)
Public Citizen calls upon the Oklahoma Board of Medical Licensure and Supervision to promptly investigate three physicians who are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/3/2012]

Letter to the Alabama Department of Public Health Regarding the LipoTron Device (HRG Publication #2058)
Public Citizen calls upon the Alabama Department of Public Health to promptly investigate health spas that are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/3/2012]

Letter to the Alabama Board of Medical Examiners Regarding the LipoTron Device (HRG Publication #2057)
Public Citizen calls upon the Alabama Board of Medical Examiners to promptly investigate two physicians who are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/3/2012]

Letter to the Medical Board of California Regarding the LipoTron Device (HRG Publication #2056)
Public Citizen calls upon the Medical Board of California to promptly investigate a physician who is actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/3/2012]

Letter to the Texas Department of State Health Services regarding the LipoTron Device (HRG Publication #2055)
Public Citizen calls upon the Texas Department of State Health Services to promptly investigate several health spas that are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/1/2012]

Letter to the Texas Medical Board regarding the LipoTron Device (HRG Publication #2054)
Public Citizen calls upon the Texas Medical Board to promptly investigate 11 physicians who are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/1/2012]

Letter to the Arkansas Department of Health regarding the LipoTron Device (HRG Publication #2053)
Public Citizen calls upon the Arkansas Department of Health to promptly investigate several health spas that are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 7/30/2012]

Letter to the Arkansas State Medical Board regarding the LipoTron Device (HRG Publication #2052)
Public Citizen calls upon the Arkansas State Medical Board to promptly investigate two physicians who are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 7/30/2012]

Letter to the Michigan Department of Community Health regarding the LipoTron Device (HRG Publication #2051)
Public Citizen calls upon the Michigan Department of Community Health to promptly investigate two health spas that are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 7/26/2012]

Letter to the Florida Department of Health Regarding the LipoTron Device (HRG Publication #2050)
Public Citizen calls upon the Florida Department of Health to promptly investigate four health spas that are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 7/26/2012]

Letter to the Florida Board of Medicine Regarding the LipoTron Device (HRG Publication #2049)
Public Citizen calls upon the Florida Board of Medicine to promptly investigate two Florida physicians who are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 7/26/2012]

Press Release: Doctors, Researchers and Health Officials Call on FDA to Change Labels on Opioid Painkillers to Deter Misprescribing (HRG Publication #2048)
Drug companies should not be permitted to advertise long-term opioids for non-cancer pain, experts say
[Created on 7/25/2012]

Follow-Up Letter to FDA Regarding LipoTron Device (HRG Publication #2047)
Public Citizen calls on the Food and Drug Administration to target Profit Solutions MD in addition to Advanced Aesthetic Concepts (AAC) for apparent illegal promotion of the unapproved LipoTron device because AAC and Profit Solutions MD are the same company. We recently recommended that the FDA immediately seize all LipoTron devices in the U.S. and order the manufacturer and its distributors to cease and desist all activities related to its distribution, sale, and promotion.
[Created on 7/23/2012]

Letter to the New Jersey State Board of Medical Examiners Regarding the LipoTron Device (HRG Publication #2046)
Public Citizen calls upon the New Jersey State Board of Medical Examiners to promptly investigate a New Jersey plastic surgeon who is actively promoting the LipoTron medical device for uses not approved by the Food and Drug Administration.
[Created on 7/23/2012]

Letter to FDA Addressing Recent Failures to Disclose New Drug Application Approval Packages in Timely Manner (HRG Publication #2045)

Public Citizen seeks a commitment from the FDA to publicly disclose new drug application (NDA) approval packages on its website within three months of approval. In recent months, the affirmative public disclosure of NDA approval packages by the FDA has either decreased or, in some cases, been greatly delayed.

[Created on 7/23/2012]

Letter to the FDA Regarding the Apparent Illegal Marketing and Promotion of the LipoTron Medical Device (HRG Publication #2044)
For several years, the Food and Drug Administration (FDA) has been aware of the apparent illegal distribution, sale, and promotion of the LipoTron medical device without the approval or clearance of the FDA.
[Created on 7/18/2012]

Statement: FDA Approval of Diet Drug Qnexa Is Reckless (HRG Publication #2043)
The U.S. Food and Drug Administration today approved Qnexa (renamed “Qsymia”), a diet pill made by Vivus, despite evidence that it poses significant risks but has little evidence of long-lasting weight loss.
[Created on 7/18/2012]

Statement: With Hundreds of Workers Dying, OSHA’s Denial of Petition for a Heat Stress Standard Is Shortsighted (HRG Publication #2042)
The Occupational Safety and Health Administration (OSHA) has denied yet another petition from Public Citizen calling for a life-saving regulation.
[Created on 7/5/2012]

Statement: GlaxoSmithKline Settlement Still Not Enough to Deter Illegal Behavior by Pharmaceutical Industry (HRG Publication #2041)
The seemingly large fines imposed on pharmaceutical companies for dangerous and illegal conduct pale in comparison to the profits generated from such activity.
[Created on 7/2/2012]

In Approving New Diet Drug, FDA Ignores Crucial Safety Data: Statement of Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group (HRG Publication #2040)
The Food and Drug Administration (FDA) today recklessly approved another diet drug, lorcaserin, the latest in a series of obesity-related pharmaceuticals that pose serious health threats.
[Created on 6/27/2012]

Letter to FDA: New reasons to reject diet drug lorcaserin (HRG Publication #2039)
Our letter urging FDA Commissioner Margaret A. Hamburg to not approve the new diet drug lorcaserin (Lorqess).
[Created on 6/26/2012]

Press Release: House and Senate Negotiators Agree on Final Legislation That Would Weaken Medical Device and Drug Safety (HRG Publication #2038)
Legislation agreed to by lawmakers from the U.S. House of Representatives and U.S. Senate bows to the powerful interests of industry by weakening medical device and prescription drug safety, Public Citizen said today. The bill could be approved by the House as soon as tomorrow. But after months of appeals to Congress identifying the dire threats to patient safety of some of the proposals in the original drafts of the bill, Public Citizen and other consumer and patient groups persuaded lawmakers to eliminate some of the most harmful provisions from the final version.
[Created on 6/19/2012]

Letter Urging Senators to Oppose Senator Coburn’s Amendment Creating Perverse Incentives for Speedier Reviews by FDA Scientific Reviewers (HRG Publication #2037)
Public Citizen urges Senators to oppose Amendment SA 2132 to the Food and Drug Administration Safety and Innovation Act (S. 3187), introduced by Senator Coburn. This amendment would weaken prescription drug and medical device safety by offering annual financial bonuses to Food and Drug Administration (FDA) scientific reviewers in exchange for speedier reviews of drugs and devices.
[Created on 5/24/2012]

Letter Urging Senators to Oppose Senator Burr’s Amendment Politicizing FDA-Industry Use-Fee Negotiations (HRG Publication #2036)
Public Citizen urges Senators to oppose Amendment SA 2130 to the Food and Drug Administration Safety and Innovation Act (S. 3187), introduced by Senator Burr. This amendment would greatly politicize the process for negotiating user-fee agreements between the Food and Drug Administration (FDA) and the drug and medical device industry, undermining the integrity of the process in ways that could threaten prescription drug and medical device safety.
[Created on 5/24/2012]

Statement and Letter from Public Citizen Supporting Sen. Bernie Sanders’ Amendment Holding Pharmaceutical Companies Accountable for Fraud (HRG Publication #2035)
Pharmaceutical Companies Must Be Held Fully Accountable for Defrauding the Government; Statement of Public Citizen’s Sammy Almashat in support of Sen. Bernie Sanders’ PDUFA amendment.
[Created on 5/22/2012]

Ranking of State Medical Boards’ Disciplinary Actions: 2009-2011 (HRG Publication #2034)
Every year, we evaluate how well each state medical board is protecting the public by disciplining doctors.
[Created on 5/17/2012]

Supplement to Petition to FDA for Tigecycline Black Box Warning (HRG Publication #2033)
Public Citizen submitted additional data supporting its October 2011 petition to the Food and Drug Administration to immediately require the addition of a black box warning to the label for tigecycline (Tygacil) indicating that the antibiotic: a) has an increased risk of death in comparison to many other antibiotics when used to treat a variety of serious infections; and b) should be used only as a last-resort antibiotic in the treatment of serious infections, and then only in combination with one or more bactericidal antibiotics.
[Created on 5/15/2012]

Statement of Dr. Michael Carome on Key House Committee to Vote on Legislation That Would Weaken Medical Device and Prescription Drug Regulations (HRG Publication #2032)
The U.S. House of Representatives Energy and Commerce Committee will meet today to deliberate and vote on legislation to renew and expand the FDA user-fee programs that bows to the powerful interests of industry by weakening medical device and prescription drug safety.
[Created on 5/10/2012]

Letter to House Energy and Commerce Committee Expressing Serious Concerns Regarding Legislation Renewing FDA User-Fee Programs (HRG Publication #2031)
Public Citizen offers the following comments regarding the expansion of the Food and Drug Administration’s (FDA’s) user-fee programs for prescription drugs and medical devices.
[Created on 5/9/2012]

Testimony on Rilonacept (ARCALYST) to the FDA’s Arthritis Advisory Committee (HRG Publication #2030)
Public Citizen strongly opposes the FDA’s approval of rilonacept for the prevention of gout flares because the drug provides no unique advantages over current treatment options and has known risks of serious infections and signals related to malignancies and adverse cardiovascular events.
[Created on 5/8/2012]

Medical Device Industry at a Crossroads: Will Industry Profits Trump Patient Safety? (HRG Publication #2029)
This spring, Congress is considering sweeping changes to the way the medical device industry is overseen. But instead of considering improvements to device safety, more often than not, lawmakers have endorsed industry-backed changes that could lead to more dangerous devices being given to patients, and therefore, more injuries and deaths.
[Created on 5/7/2012]

Public Citizen Comment on Corrective Ad Study (HRG Publication #2028)
Public Citizen comments on a notice by the Food and Drug Administration describing research on corrective advertising. Public Citizen has concerns that the study described in this notice would fail to provide useful information to policymakers, and proposes an alternative study design.
[Created on 4/27/2012]

Letter to the FDA opposing approval of the drug mirabegron (HRG Publication #2027)
Public Citizen strongly opposes Food and Drug Administration (FDA) approval of the new drug application for mirabegron — submitted by Astellas Pharma Global Development and considered by the FDA’s Advisory Committee for Reproductive Health Drugs on April 5, 2012 — because (1) the drug is not a major breakthrough treatment, has no unique advantages over current treatment options, and offers only marginal symptomatic benefits for overactive bladder, a disorder that is not life-threatening; and (2) there are serious safety signals indicating risk of potentially life-threatening harm to patients.
[Created on 4/27/2012]

Statement of Dr. Sammy Almashat: Shame on Obama Administration for Sacrificing Children to Keep Agribusiness Happy (HRG Publication #2026)
The Obama administration on Thursday once again sided with industry instead of workers on regulations and withdrew the Department of Labor’s (DOL) proposed rules that would have restricted child workers from the most dangerous tasks in agriculture.
[Created on 4/27/2012]

Comments on FDA Guidance on Substantial Equivalence (HRG Publication #2025)
Public Citizen opposes the FDA’s draft guidance on evaluating substantial equivalence of medical devices reviewed under the 510(k) premarket notification process because it would perpetuate the agency’s long-standing, overly permissive interpretations of substantial equivalence. Such interpretations have allowed the agency to clear many novel moderate- to high-risk devices that differ significantly from their already-marketed predicate devices without such new devices undergoing the appropriate clinical testing.
[Created on 4/26/2012]

Letter of support for Senator Sanders’ PDUFA amendment on pharmaceutical fraud (HRG Publication #2024)
We support Senator Sanders’ first amendment to the Prescription Drug User Fee Act (PDUFA) package concerning pharmaceutical fraud (Sanders/Amendment #1). The amendment would rescind exclusivity rights granted under the federal Food, Drug, and Cosmetic Act (FD&C Act) for any future pharmaceutical product, if the company marketing the product has been found, or admits to, engaging in unlawful activity involving the drug.
[Created on 4/24/2012]

Letter to Senate HELP Committee Expressing Serious Concerns Regarding the Proposed Food and Drug Administration Safety and Innovation Act (HRG Publication #2023)
Public Citizen has serious concerns about some of the provisions in the April 23 Manager’s Amendment of the Food and Drug Administration Safety and Innovation Act, which will be considered by the Senate Committee on Health, Education, Labor, and Pensions (HELP Committee) when it convenes in executive session on April 25.
[Created on 4/24/2012]

Letter to Senate HELP Committee Opposing the PATIENTS’ FDA Act (HRG Publication #2022)
Public Citizen strongly opposes the Promoting Accountability, Transparency, Innovation, Efficiency, and Timeliness at the FDA Act of 2012 (the PATIENTS’ FDA Act), drafted by Senators Richard Burr and Tom Coburn, because the bill would substantially weaken the Food and Drug Administration’s (FDA’s) regulatory oversight of medical products — particularly those related to medical devices — and thus poses a significant threat to the health and lives of patients.
[Created on 4/23/2012]

Statement of Sammy Almashat at The National Press Club Regarding Child Labor on Farms in the U.S. (HRG Publication #2021)
On American farms children as young as 12 can be hired to perform dangerous work. Their bodies are structured fundamentally differently, leaving them uniquely vulnerable to a number of different hazards, many of which go unnoticed by the employer, the child, and parent alike resulting in one of the highest child mortality rates of any industry.
[Created on 4/19/2012]

Petition to Ban Diabetes Drug Liraglutide (Victoza) (HRG Publication #2020)
Public Citizen petitions the Food and Drug Administration (FDA) to immediately remove from the market the diabetes drug liraglutide (Victoza; Novo Nordisk) because the known increased risks of thyroid cancer and pancreatitis outweigh any documented clinical benefits.
[Created on 4/19/2012]

Letter to the House Subcommittee on Health of the Committee on Energy and Commerce Opposing Legislation Proposing to Amend the Food, Drug and Cosmetic Act (HRG Publication #2019)
Public Citizen strongly opposes the Subcommittee on Health’s draft legislation proposing to renew the Food and Drug Administration’s (FDA’s) user fee program and to make other amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) regarding the regulation of medical devices and drugs.
[Created on 4/17/2012]

Letter to the FDA Opposing Resumption of Clinical Trials Testing Anti-Nerve Growth Factor Drugs (HRG Publication #2018)
The Food and Drug Administration (FDA) should reject the recommendation of the Arthritis Advisory Committee to resume clinical development of anti-nerve growth factor drugs for management of chronic pain. Further human studies of these drugs would be unethical and not approvable under FDA regulations for the protection of human subjects because the risks outweigh the potential benefits to subjects and the importance of the knowledge that is expected to result.
[Created on 4/16/2012]

Letter to the Senate HELP Committee Opposing Draft Legislation Proposing Incentives for Antibiotic Development (HRG Publication #2017)
Public Citizen comments on the March 29 discussion draft of legislation amending the Federal Food, Drug, and Cosmetic Act to incentivize new antibiotic development that was prepared by the Senate Committee on Health, Education, Labor, and Pensions that would provide drug companies with large financial incentives to develop new antibiotics and mandate that the Food and Drug Administration (FDA) review these drugs more rapidly.
[Created on 4/9/2012]

Statement of Dr. Michael Carome on Sheridan Hospital’s Response in Wake of Public Disclosure of Inadequate Sterilization of Surgical Equipment (HRG Publication #2016)
Public Citizen prompts Wyoming hospital to act responsibly in responding to patient exposures to inadequately sterilized equipment.
[Created on 4/5/2012]

Comments Submitted to the Centers for Medicare and Medicaid Services (CMS) Regarding the Emergency Medical Treatment and Active Labor Act (EMTALA) (HRG Publication #2015)
Public Citizen and the National Women’s Health Network (NWHN) submitted comments to CMS asserting that EMTALA requires hospitals with specialized capabilities to accept an appropriate transfer of a patient with an emergency medical condition who has already been admitted as an inpatient to another hospital. Public Citizen and the NWHN urged CMS to issue regulations implementing this requirement.
[Created on 4/3/2012]

Recommendations on the Senate HELP Committee Draft Medical Device Bill (HRG Publication #2014)
Public Citizen comments on the March 16 discussion draft of medical device policy legislation prepared by the Senate Committee on Health, Education, Labor, and Pensions (the HELP Committee) concerning a number of provisions in the discussion draft legislation to amend the Federal Food, Drug, and Cosmetic Act (FDCA).
[Created on 4/2/2012]

Comments on National Practitioner Data Bank (NPDB) NPRM, Feb. 15, 2012, Federal Register/Vol. 77, No. 31, pages 9138-9161 (HRG Publication #2013)
Public Citizen provided comments on a Feb. 15, 2012, Federal Register Notice of Proposed Rulemaking that addressed over-lap between the National Practitioner Data Bank (NPDB) and the HealthCare Integrity and Protection Data Bank. Our comments recommended that the Department of Health & Human Services (HHS) require Medicare Quality Improvement Organizations to report to the NPDB. We also recommended that HHS expand the definition of a “reportable event” so that more adverse actions by medical boards and health care organizations would be submitted to the NPDB.
[Created on 3/29/2012]

Testimony Before FDA Endocrinologic and Metabolic Drugs Advisory Committee Meeting on Cardiovascular Risk Assessment of Obesity Drugs (HRG Publication #2012)
A dangerously low approval standard for diet drugs has created a history of recalls, injuries, and needless deaths.
[Created on 3/29/2012]

Testimony to the FDA’s Neurological Devices Panel of the Medical Devices Advisory Committee Regarding the Wingspan Stent System (HRG Publication #2011)
An NIH-funded study of the Wingspan Stent System conclusively demonstrated that treatment of high-risk patients with intracranial artery stenosis with the Wingspan Stent System plus aggressive medical therapy causes significantly more harm and is no more effective in comparison to aggressive medical treatment alone. Therefore, the criteria for withdrawal of humanitarian device exemption approval under FDA regulations have been met for this device.
[Created on 3/23/2012]

Letter to Sheridan Memorial Hospital (HRG Publication #2010)
Our letter to Sheridan Memorial Hospital (SMH) regarding the inaccurate and misleading public statements issued by the hospital following the public disclosure of SMH’s failure to properly sterilize or disinfect reusable laryngeal mask airways between uses in patients undergoing surgery. This SMH failure was characterized by the Wyoming Department of Health as “an immediate jeopardy situation.”
[Created on 3/20/2012]

Letter to the Editor of the Casper Star-Tribune Regarding Sheridan Memorial Hospital and the Wyoming Department of Health (HRG Publication #2009)
In a letter to the editor of the Casper Star-Tribune, Public Citizen responded to the March 14 article, “Report shows Sheridan hospital failed to sterilize equipment last year.” Claims by Sheridan Memorial Hospital and the Wyoming Department of Health that there have been no infections or complications reported in relation to the hospital’s failure to adequately sterilize the laryngeal airway masks between surgical patient uses is ludicrous for two reasons.
[Created on 3/16/2012]

Letter to Wyoming Department of Health Regarding Sheridan Memorial Hospital (HRG Publication #2008)
Public Citizen recently learned from an internal hospital memo and other sources of information that in a November 2011 inspection at Wyoming’s Sheridan Memorial Hospital in Sheridan, the Wyoming Department of Health discovered that the hospital was no longer properly sterilizing or disinfecting reusable laryngeal mask airways (LMAs) between uses in patients undergoing surgery. As a result, several hundred patients undergoing surgery at a Wyoming hospital may have been exposed to a variety of infectious viral and bacterial agents over a period of several months.
[Created on 3/13/2012]

Testimony to the FDA’s Arthritis Advisory Committee on Safety Issues Related to Anti-Nerve Growth Factor Agents (HRG Publication #2007)
We strongly urge the Food and Drug Administration (FDA) to permanently suspend the clinical development of these anti-nerve growth factor (anti-NGF) agents for the treatment of pain because of the dramatic safety signal seen in clinical studies of these agents demonstrating an unusually high incidence of rapid joint destruction.
[Created on 3/12/2012]

Substantially Unsafe: Medical Devices Pose Great Threat to Patients; Safeguards Must be Strengthened, Not Weakened (HRG Publication #2006)
The medical device industry is engaging in a massive lobbying effort designed to weaken already lax oversight and speed already quick review of its high-risk products, a new Public Citizen study finds.
[Created on 2/15/2012]

Letter to OHRP Regarding Testing the Drug Canakinumab in Diabetic Children Without Adequate Informed Consent/Parental Permission (HRG Publication #2005)
In a follow-up letter to the Office for Human Research Protections regarding a clinical study testing the drug canakinumab in children with type I diabetes, Public Citizen reported that its review of the research protocol and informed consent document for this study reaffirms and provides evidence for Public Citizen’s initial allegation that this research was not conducted in compliance with the requirements of HHS human subjects protection. Furthermore, Public Citizen’s review of the sample informed consent/parental permission form for the study reveals that the description of the risks and benefits of the research failed to satisfy the requirements of HHS regulations regarding informed consent for research.
[Created on 2/28/2012]

Letter to CMS and OHRP Opposing Proposal to Require Medicare Beneficiaries Undergoing an Aortic Valve Replacement Procedure to Participate in Research Without Their Informed Consent (HRG Publication #2004)
In a letter to the Centers for Medicare and Medicaid Services (CMS) and the Office for Human Research Protections, Public Citizen objected to CMS’s proposal to require Medicare patients to participate in research as a condition of coverage for transcatheter aortic valve replacement because the policy as proposed fails to comply with the requirements for obtaining informed consent for research.
[Created on 2/28/2012]

Letter to the FDA Opposing Reclassification of Cranial Electrotherapy Stimulator Devices (HRG Publication #2003)
In a letter to the Food and Drug Administration, Public Citizen opposed the reclassification of cranial electrotherapy stimulator devices—which are indicated for the treatment of depression, anxiety, and insomnia—from the high-risk class III category to the moderate-risk class II category.
[Created on 2/28/2012]

Comments to FDA on Direct-to-Consumer Drug Advertisements (HRG Publication #2002)
Direct-to-consumer advertising should be carefully regulated and required to include clear, specific, and easy-to-understand audio and visual explanations of the product’s risks and benefits, along with the risks and benefits of alternative therapies. A recent FDA-funded study on distraction in direct-to-consumer drug advertising was not well-designed to detect the effects of distraction on consumer comprehension of risks, and cannot be used as a guide for policymaking.
[Created on 2/27/2012]

Testimony Before FDA Endocrinologic and Metabolic Drugs Advisory Committee Meeting on Qnexa (HRG Publication #2001)
The new weight loss drug combination phentermine and topiramate (Qnexa) causes serious adverse events and should again be rejected by the FDA.
[Created on 2/22/2012]

Statement to the Subcommittee on Health of the House Energy and Commerce Committee Advocating for Legislation to Improve Medical Device Safety (HRG Publication #2000)
Public Citizen’s Health Research Group urges Subcommittee on Health of the House Energy and Commerce Committee members to support bills such as H.R. 3847, the Safety of Untested and New Devices Act (the SOUND Devices Act) of 2012, that would improve patient safety — rather than threaten it.
[Created on 2/15/2012]

Letter to Medicare and Medicaid on Wingspan Stent System (HRG Publication #1999)
Public Citizen urges the Centers for Medicare and Medicaid Services to withdraw coverage for the Wingspan Stent System and similar systems, because new data reveals that these systems provide no benefits and dramatically increase the risk of stroke or death.
[Created on 2/14/2012]

Letter to FDA on Wingspan Stent System (HRG Publication #1998)
Public Citizen states that FDA should not categorize future investigations using the Wingspan Stent System or similar systems as Category B, because it is a class III device and underlying questions of safety and effectiveness have not been resolved.
[Created on 2/14/2012]

Letter to FDA Opposing Approval of Loxapine Inhalation Powder (Adasuve) (HRG Publication #1997)
Public Citizen’s Health Research Group strongly opposes FDA approval of loxapine (Adasuve) inhalation powder for treatment of schizophrenia or bipolar I disorder in adults due to no evidence from clinical trials that it offers any benefits over currently-available treatments and that it can cause life-threatening pulmonary toxicity.
[Created on 1/23/2012]

Letter to FDA Opposing Premarket Approval Application for the CardioMEMS Champion Heart Failure Monitoring System (HRG Publication #1996)
Comments from the Health Research Group at Public Citizen submitted in follow-up to our testimony presented at the December 8, 2011 meeting of the Food and Drug Administration’s (FDA’s) Circulatory System Devices Panel of the Medical Devices Advisory Committee regarding Premarket Approval (PMA) application for the CardioMEMS Champion Heart Failure Monitoring System (the CardioMEMS System).
[Created on 1/19/2012]

Public Citizen Comment on External Pacemaker Reclassification (HRG Publication #1995)
Public Citizen strongly urges the Food and Drug Administration (FDA) to withdraw its proposed rule to reclassify the external pacemaker pulse generator preamendment Class III device arbitrarily to Class II (special controls) and to publish a new notice immediately that proposes a final regulation requiring the device to remain in Class III, and requiring premarket approval applications for new external pacemaker pulse generators.
[Created on 1/17/2012]

Supplement to Petition to FDA to Withdraw Approval of Wingspan Stent System (HRG Publication #1994)
Public Citizen wishes to supplement its December 21, 2011 petition to the Food and Drug Administration (FDA).
[Created on 1/12/2012]

Letter Regarding FDA’s Unreasonable Delay in Fining Red Cross for Blood Banking Violations (HRG Publication #1993)
The Food and Drug Administration (FDA) should immediately impose a nearly $10 million fine on the American Red Cross because of hundreds of violations the agency found in a 2010 inspection of a donor support center in Philadelphia, Public Citizen said in a letter sent to Health and Human Services Secretary Kathleen Sebelius.
[Created on 1/6/2012]

2011

Petition to FDA to Withdraw Approval of Wingspan Stent System (HRG Publication #1992)
The Food and Drug Administration (FDA) should immediately withdraw its approval of a medical device that is supposed to prevent strokes in people who already have had one because a recent study found that the device actually increases the risk of subsequent strokes and death.
[Created on 12/21/2011]

Supplement to Petition to Ban Bedside Assistant Bed Handles and Similar Medical Devices (HRG Publication #1991)
Our recent review of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database revealed a September 13, 2011 report of a patient who died from strangulation and suffocation on February 5, 2011, after becoming entrapped by a Home Bed Assist Rail, model number 15064, manufactured by Drive.
[Created on 12/13/2011]

Letter in Science – Rethinking Clinical Trials: Phase 1 Studies Insufficient (HRG Publication #1990)
In his editorial “Rethinking Clinical Trails”, A. Grove proposes returning to the dangerous era before the enactment of the 1938 Federal Food, Drug, and Cosmetic Act, when new drugs were marketed in the United States without evidence that they were safe or effective.
[Created on 12/9/2011]

Testimony on Ethinyl Estradiol/Norelgestromin (Ortho-Evra) (HRG Publication #1989)
If the Ortha Evra patch has no unique benefits and, relative to equally effective oral contraceptives with lower estrogen doses, has a higher risk of blood clots, there is no reason to leave it on the market. Although prescriptions have dropped markedly in the past seven years, more than a million prescriptions a year are still filled for the patch. Women using these prescriptions are at increased risk with no significant, documented benefit.
[Created on 12/9/2011]

Testimony to FDA on CardioMEMS Champion HF Monitoring System (HRG Publication #1988)
Public Citizen strongly recommends that the FDA, in order to protect public health, not approve the premarket approval (PMA) application for the CardioMEMS System.
[Created on 12/8/2011]

Removal of Consumer Advocate From Dec. 8 Advisory Committee Meeting Is Bad Policy (HRG Publication #1987)
This morning, less than 48 hours from the beginning of Thursday’s Food and Drug Administration (FDA) advisory committee meeting to discuss the risks of blood clots from the birth control pills Yaz and Yasmin, Health Research Group director Dr. Sidney Wolfe was notified in a phone call from FDA’s Office of Advisors and Consultants that he could not participate as a member of the Drug Safety and Risk Management Advisory Committee in that meeting because of what the agency calls his “intellectual conflict of interest.”
[Created on 12/6/2011]

Comments on Proposed Rule on Agricultural Child-Labor Regulations (HRG Publication #1986)
Public Citizen is requesting that the Department of Labor institute protections against extreme heat exposure for all child farmworkers under the age of 16.
[Created on 12/1/2011]

Statement: FDA’s Rejection of Public Citizen’s Petition to Ban Rosiglitazone (Avandia) Translates to More Harm to Patients (HRG Publication #1985)
Late yesterday, the FDA faxed Public Citizen its letter rejecting our October 30, 2008 petition in which we asked the FDA to ban rosiglitazone (Avandia) because its benefits were greatly outweighed by its multiple risks, including increased heart attacks, heart failure, fractures, vision-threatening macular edema and other serious problems.
[Created on 11/22/2011]

Statement: Restoration of Doctor Discipline Database Excludes Some Reporters (HRG Publication #1984)
For users of these data such as Public Citizen, academic researchers and journalists, the restoration of the National Practitioner Data Bank’s Public Use File is an important step in the right direction since the file has been down for more than two months. The downside, however, is that as a new condition of obtaining the data, users will have to agree not to use this entirely confidential information (not identifying any physician by name) in combination with publicly available information to identify and develop extended profiles on specific doctors.
[Created on 11/9/2011]

Letter Opposing Draft Guidance Regarding Use of Exculpatory Language in Informed Consent for Research (HRG Publication #1983)
Public Citizen strongly opposes the proposed draft guidance on exculpatory language in informed consent because, contrary to the Federal Register notice announcing the availability of this draft guidance document for comment (76 FR 55390) – which states that the Office for Human Research Protections and the Food and Drug Administration are seeking to “enhance human subjects protection” by “actively working to harmonize the agencies’ regulatory requirements and guidance for human subjects research” – the proposed guidance would weaken protections for human subjects.
[Created on 11/7/2011]

Testimony Against the Removal of National Practitioner Data Bank (NPDB) Public Use Data File (HRG Publication #1982)
On September 1, 2011, the Department of Health and Human Services unwisely decided to remove the NPDB Public Use Data File from the Internet because of a complaint by a physician in Kansas that an investigation by a local reporter, combining publicly available information about the Kansas physician with unidentifiable information from the NPDB, had made it possible to provide a more complete summary of actions taken involving the physician.
[Created on 11/3/2011]

Letter Responding to OSHA’s Denial of Resident Work Hours Petition (HRG Publication #1981)
OSHA has opted out of its legal obligation to protect residents from excessive work hours, deferring instead to a largely unaccountable private entity, the Accreditation Council for Graduate Medical Education.
[Created on 11/3/2011]

Letter Opposing Senate Bill S. 1700 (HRG Publication #1980)
Public Citizen strongly opposes Senate Bill S. 1700, the Medical Device Regulatory Improvement Act, because, contrary to the bill’s title, the proposed amendments to the Federal Food, Drug, and Cosmetic Act would weaken the already inadequate regulatory requirements for medical devices approved under the premarket approval process or cleared under the 510(k) premarket clearance process.
[Created on 11/1/2011]

Letter Opposing Unethical Anthrax Vaccine Studies on Children (HRG Publication #1979)
Public Citizen urges you to reject the National Biodefense Science Board’s recommendation to conduct pre-event clinical trials of the anthrax vaccine in children. Such trials would be unethical and are prohibited under the Department of Health and Human Services and Food and Drug Administration regulations for the protection of human subjects.
[Created on 11/1/2011]

Comments on Proposals to Revise the Regulations for Protecting Human Research Subjects (HRG Publication #1978)
Public Citizen’s comments in response to Advance Notice of Proposed Rulemaking (ANPRM) – Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators (Docket number HHS-OPHS-2011-0005).
[Created on 10/26/2011]

Petition Requesting Black Box Warning on Tigecycline (Tygacil) (HRG Publication #1977)
Public Citizen petitions the Food and Drug Administration to immediately require the addition of a black box warning to the label for tigecycline (Tygacil) indicating that the antibiotic: a) has an increased risk of death in comparison to many other antibiotics when used to treat a variety of serious infections; and b) should be used only as a last-resort antibiotic in the treatment of serious infections, and then only in combination with one or more bactericidal antibiotics.
[Created on 10/26/2011]

Letter to HHS and Department of Defense Urging Investigation Into Procedures Leading to Blood Platelet Transfusion Deaths (HRG Publication #1976)
The purpose of this letter is to urge an immediate external investigation in order to stop unequivocally dangerous procedures at the Bethesda National Naval Medical Center (NNMC), now the Walter Reed National Military Medical Center, and possible problems at the National Institutes of Health (NIH) that have resulted in the recent deaths (in August and September) of two NIH patients because they were given transfusions of blood platelets (blood cells that help to stop bleeding) previously determined and labeled by the NNMC blood bank to be infected with bacteria.
[Created on 10/25/2011]

Letter to FDA Urging Rejection of Florbetapir F18 Injection (Amyvid) Based on Newly Published Expert Analysis (HRG Publication #1975)
[Created on 10/21/2011]

Letter to FDA Opposing Approval of Rivaroxaban (Xarelto) for Anticoagulation Therapy in Patients With Atrial Fibrillation (HRG Publication #1974)
We strongly oppose FDA approval of Johnson & Johnson’s NDA for rivaroxaban for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, a condition for which two proven therapies already exist.
[Created on 10/20/2011]

Letter to FDA Opposing Approval of Deferiprone (HRG Publication #1973)
We strongly oppose FDA approval of ApoPharma’s NDA for deferiprone for treatment of patients with transfusional iron overload when current chelation therapy is inadequate because the data presented by the sponsor in support of the NDA were grossly insufficient and fail to demonstrate that deferiprone is safe and effective in the intended patient population (i.e., any patient with transfusional iron overload), even under the standards permitted under FDA regulations at 21 C.F.R. Part 314, Subpart H (“Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses”).
[Created on 10/12/2011]

Public Citizen poses serious concerns to the FDA about the testing of liraglutide in children (HRG Publication #1972)
Public Citizen believes that the required pediatric studies for Novo Nordisk’s new drug liraglutide (Victoza) are unethical and fail to satisfy the requirements of the FDA regulations for pediatric testing.
[Created on 9/15/2011]

Letter Regarding NPDB Public Use File Availability (HRG Publication #1971)
Public Citizen is quite concerned that the Health Resources and Services Administration (HRSA) recently removed the National Practitioner Data Bank (NPDB) Public Use Data File from the NPDB’s website.
[Created on 9/13/2011]

Testimony Regarding Bisphosphonates (HRG Publication #1970)
We urge the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee to recommend the following to the Food and Drug Administration (FDA): 1) long-term use of bisphosphonates for the prevention of osteoporotic fractures must be limited to 5 years, and 2) the indication for bisphosphonate treatment for osteopenic women must be removed, unless the patient has a significant 10-year fracture risk as determined by the World Health Organization’s (WHO) FRAX algorithm.
[Created on 9/9/2011]

Testimony on Non-Absorbable Synthetic Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (HRG Publication #1969)
We endorse the FDA’s belated proposal to reclassify non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP to class III and require PMA evaluations, but this action alone is insufficient. To properly protect the public health, the FDA also must immediately (1) ban all such mesh products currently available, and (2) require manufactures to recall these dangerous and ineffective devices. A grace period allowing continued marketing of these devices would recklessly endanger women. Further clinical trials with current devices, as requested by the FDA, would be highly unethical.
[Created on 9/8/2011]

Statement: Medical Schools Provide Their Students With Inadequate Coverage for Mental Health and Substance Abuse Treatment (HRG Publication #1968)
Public Citizen strongly endorses the recommendation by the authors of the JAMA study that U.S. medical schools move immediately to improve student insurance coverage for mental health and substance abuse disorders.
[Created on 9/2/2011]

Comments Regarding the IOM’s Report, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years (HRG Publication #1967)
Public Citizen’s Health Research Group completely agrees with the main conclusion of the Institute of Medicine’s (IOM) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process (the committee) that the Food and Drug Administration (FDA) 510(k) process for clearing medical devices is broken and cannot be fixed.
[Created on 9/2/2011]

Petition for a Heat Standard (HRG Publication #1966)
Public Citizen petitions the Occupational Safety and Health Administration (OSHA), pursuant to section 6(c) of the Occupational Safety and Health Act, 29 U.S.C. § 655(c), to issue an Emergency Temporary Standard (ETS) for a heat stress threshold that will protect workers from suffering unnecessary and entirely preventable health effects, including death, from excessive indoor and outdoor heat exposure. We are also requesting that OSHA immediately initiate the usual rulemaking process for a permanent heat stress standard, pursuant to 29 U.S.C. § 655(b) that would include the heat threshold above, in addition to multiple other proven protective measures from extreme heat.
[Created on 9/1/2011]

Food and Drug Administration Petition on Generic Drug Labeling (HRG Publication #1965)
Public Citizen requests that the FDA authorize generic drug manufacturers to revise generic drug labeling through the changes-being-effected (CBE) and prior-approval-supplement (PAS) procedures.
[Created on 8/29/2011]

Petition Urging FDA to Add Warnings to Proton Pump Inhibitors (HRG Publication #1964)
Public Citizen petitions the FDA to immediately add black box warnings and other safety information concerning several severe risks to the product labels of all proton pump inhibitors (PPIs) presently on the market in the U.S. In addition, the serious nature of so many of these adverse reactions also mandates the requirement for FDA-approved patient Medication Guides, none of which exist now, for all of these drugs.
[Created on 8/23/2011]

Petition to Ban Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (HRG Publication #1963)
Public Citizen petitions the FDA to ban the marketing of all currently available non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of pelvic organ prolapse (POP), order all manufacturers of these devices to recall these products and require that any non-absorbable surgical mesh product specifically designed and labeled for transvaginal repair of POP that is proposed for marketing in the future be classified as a class III device and be approved for marketing only under a premarket approval application that includes data from well-designed, prospective clinical trials that provide a reasonable assurance that the surgical mesh product is safe and effective.
[Created on 8/25/2011]

Letter Regarding Performance of Medical Board of California (HRG Publication #1962)
Public Citizen is very concerned that 1) the Medical Board of California has failed to take any disciplinary action against 710 physicians who have been disciplined by hospital or other peer review; 2) there has been a significant decline in the Medical Board’s rate of serious discipline of physicians, as determined by Public Citizen’s annual ranking of medical boards; and 3) significant recommendations, including recommendations to give priority to such peer review actions against doctors, from the Enforcement Monitor’s 2005 final report remain unimplemented.
[Created on 8/9/2011]

Comments to CMS Regarding End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) for Payment Years (PY) 2013 and 2014: Provisions for Assessing the Quality of Anemia Management with Erythropoiesis-Stimulating Agents (ESAs) (HRG Publication #1961)
Public Citizen’s Health Research Group has comments regarding the provisions of the proposed rule referenced above that relate to assessing the quality of anemia management with ESAs in chronic kidney disease patients on dialysis.
[Created on 8/1/2011]

Statement on IOM Report on 510(k) Clearance Process (HRG Publication #1960)
Public Citizen applauds the critically important July 29, 2011, report of the Institute of Medicine’s Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, which concluded that the FDA’s 510(k) process for clearing medical devices is broken and cannot be fixed.
[Created on 7/29/2011]

Letter Requesting Extension of ANPRM Comment Period (HRG Publication #1959)
Regarding the Advance Notice of Proposed Rulemaking (ANPRM) on HHS-OPHS-2011-0005 (Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators), we call upon HHS to promptly issue an amended ANPRM that extends the comment period from 60 days to a minimum of 120 days.
[Created on 7/26/2011]

Petition Requesting Warnings on the Labels of Glucocorticosteroids (HRG Publication #1958)
The FDA should immediately require that the labels for all brands of prednisone and other glucocorticosteroids currently on the market in the U.S. be revised to include central serous chorioretinopathy as one of the ophthalmic adverse reactions reported with these medications if not already included. The FDA should also ensure that other important information regarding the use and safety of these medications is presented in a consistent manner across all labels.
[Created on 7/26/2011]

Testimony on Dapagliflozin (HRG Publication #1957)
A drug proposed to treat patients with diabetes should not be approved because it has serious risks and no evidence of clinical benefit.
[Created on 7/19/2011]

Letter to OHRP Regarding Canakinumab (Ilaris) (HRG Publication #1956)
We hereby request that the Office for Human Research Protections (OHRP) promptly conduct a compliance oversight investigation of an ongoing research study that is entirely supported by the Department of Health and Human Services (HHS).
[Created on 7/19/2011]

Follow-Up Letter to FDA Regarding Canakinumab (Ilaris) (HRG Publication #1955)
These comments from the Public Citizen Health Research Group (HRG) are being submitted to follow up on our testimony presented at the June 21, 2011 meeting of the Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) regarding the supplemental Biologics License Application (sBLA) #125319 for the drug canakinumab (Ilaris).
[Created on 7/19/2011]

Press Release: OSHA Drags Its Feet on Study Regarding Workers’ Exposure to Toxic Substance (HRG Publication #1954)
The release of the Occupational Health and Safety Administration’s (OSHA) regulatory agenda today reveals that the agency has failed to take any concrete steps since last year on limiting workers’ exposure to the toxic substance beryllium and has no plans to do so anytime soon.
[Created on 7/7/2011]

Follow-up Letter to CMS Regarding Erythropoiesis-Stimulating Agents (ESAs) in Chronic Kidney Disease (CKD) Patients (HRG Publication #1953)
It is imperative that the Center for Medicare & Medicaid Services (CMS) follow the Food and Drug Administration’s (FDA) lead and issue a national coverage decision for ESAs that fully aligns with FDA’s new, more conservative recommendations regarding the dosing of ESAs and the upper limit of target hemoglobin levels in patients with chronic kidney disease.
[Created on 6/22/2011]

FDA Should Have Advised Women Against Getting Silicone Breast Implants for Cosmetic Reasons (HRG Publication #1952)
The Food and Drug Administration’s (FDA) update today stating that although silicone breast implants have “a reasonable assurance of safety … the longer a woman has breast implants, the more likely she is to experience local complications or adverse outcomes,” is unquestionably shortsighted as well as contradictory.
[Created on 6/22/2011]

Testimony on Ilaris (Canakinumab) (HRG Publication #1951)
We oppose the Food and Drug Administration’s (FDA) approval of canakinumab, a potent immunosuppressant agent, for the treatment of patients with gouty arthritis attacks because the drug has serious, life-threatening risks that far outweigh the drug’s clinical benefits, which are limited primarily to relief of pain from acute gout flares in this patient population.
[Created on 6/21/2011]

Petition to Ban 23 Milligram Dose of Donepezil (Aricept) (HRG Publication #1950)
The 23 milligram dose of donepezil (Aricept), which is used to treat moderate or severe cases of Alzheimer’s disease, should be removed from the market immediately because of its risk of serious adverse effects and its lack of effectiveness.
[Created on 5/18/2011]

Ranking of the Rate of State Medical Boards’ Serious Disciplinary Actions, 2008-2010 (HRG Publication #1949)
[Created on 5/12/2011]

Public Citizen Exposes Serious Omissions in Published Study of Experimental Procedure for Diagnosing Alzheimer’s Disease (HRG Publication #1948)
In a letter published today in the Journal of the American Medical Association (JAMA), Public Citizen criticized the authors of a study in the January 19, 2011 issue of the journal who tested the effectiveness of brain scans using an experimental dye for detecting brain abnormalities found in patients with Alzheimer’s disease. The authors withheld critically important data from the Journal when documenting the extent to which interpretation of these scans varies from one physician to another, Public Citizen said.
[Created on 5/10/2011]

Petition to Ban Bedside Assistant Bed Handles, Model Numbers BA10W and BA10W-6, Manufactured by Bed Handles, Inc. (HRG Publication #1947)
Public Citizen petitions the Food and Drug Administration (FDA) to immediately ban the marketing of Bedside Assistant® bed handles, model numbers BA10W and BA10W-6, manufactured by Bed Handles, Inc., because these devices have directly caused the deaths of at least four adult patients through entrapment and subsequent strangulation or positional asphyxia and therefore present “an unreasonable and substantial risk of illness or injury,” the standard for the FDA to institute proceedings to ban a device under the device law.
[Created on 5/4/2011]

Letter to HHS Regarding OHRP Failure to Investigate Unethical Placebo-Controlled Trials of Indacaterol Maleate (Arcapta Neohaler) (HRG Publication #1946)
The Public Citizen Health Research Group urges the Department of Health and Human Services (HHS) to direct the Office for Human Research Protections (OHRP) to assert its leadership and regulatory authority by opening a compliance oversight evaluation of a series of unethical, placebo-controlled clinical trials testing the experimental drug indacaterol in human subjects with moderate to severe chronic obstructive pulmonary disease; or alternatively, refer the matter to another independent entity, such as the HHS Office of the Inspector General, to evaluate the matter.
[Created on 4/28/2011]

Petition to FDA to Ban Powdered and Latex Surgeon’s and Patient Examination Gloves (HRG Publication #1945)
Public Citizen petitions the Food and Drug Administration (FDA) to immediately (a) ban the use of cornstarch powder on all surgeon’s and patient examination gloves, and (b) ban the use of all natural latex rubber surgeon’s and patient examination gloves, because of the serious threat posed by these products to patients and healthcare workers and the ready availability of widely used safer alternatives (i.e., powder-free synthetic gloves).
[Created on 4/25/2011]

Researching the Backgrounds of Health Professionals (HRG Publication #1944)
Dr. Wolfe advises members of the Association of Health Care Journalists on how to research the backgrounds of health professionals.
[Created on 4/16/2011]

Letter to CMS Opposing Proposal Not to Issue a National Coverage Decision Regarding Erythropoiesis Stimulating Agents (ESAs) (HRG Publication #1943)
We strongly oppose the proposal that the Center for Medicare and Medicaid Services (CMS) not issue a national coverage determination at this time for Erythropoiesis Stimulating Agents (ESAs) for treatment of anemia regarding ESAs for the treatment of anemia in adults with chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
[Created on 4/15/2011]

Petition to Ban Orlistat (Alli, Xenical) (HRG Publication #1942)
Public Citizen petitions the Food and Drug Administration (FDA) to immediately ban both the prescription drug, Xenical (orlistat; Hoffman-La Roche), and the over-the-counter (OTC) drug, Alli (orlistat; GlaxoSmithKline), because they expose patients to serious risks that greatly outweigh their minimal clinical benefits.
[Created on 4/14/2011]

Testimony on Disciplinary Actions by the New Jersey Board of Medical Examiners (HRG Publication #1941)
Dr. Wolfe discusses the board’s failure to discipline 183 doctors who had serious admitting privilege actions taken against them by hospitals, the performance of the board for the past 20 years and what the board can do to improve its performance.
[Created on 4/11/2011]

Comments on FDA Medical Device Innovation Initiative (HRG Publication #1940)
We caution the Food and Drug Administration (FDA) to take steps to ensure (a) the safety of human subjects and patients, and (b) integrity of the review process under the proposed Innovation Pathway.
[Created on 4/7/2011]

Letter to OHRP on Unethical Trials of Indacaterol Maleate (Arcapta Neohaler) (HRG Publication #1939)
We hereby request that the Office for Human Research Protections (OHRP) conduct a compliance oversight evaluation of several unethicals trials of indacaterol maleate (Arcapta Neohaler).
[Created on 3/16/2011]

Letter to FDA on Indacaterol Maleate (Arcapta Neohaler) (HRG Publication #1938)
These comments from the Public Citizen Health Research Group are being submitted in follow-up to our testimony presented at the March 8, 2011 meeting of the Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) regarding the drug indacaterol maleate (Arcapta™ Neohaler™).
[Created on 3/16/2011]

State Medical Boards Fail To Discipline Doctors With Hospital Actions Against Them (HRG Publication #1937)
An analysis of the National Practitioner Data Bank Public Use File for 1990-2009 found that of a total of 10,672 physicians in the data bank with one or more clinical privilege actions — revocation or restriction of their clinical privileges — 45% also had one or more state licensing actions. However 5,887, or 55%, of these physicians — more than half — had no state licensing actions.
[Created on 3/15/2011]

Letter on Failure to Warn U.S. Doctors and Patients of Zoledronic Acid (Reclast) Dangers (HRG Publication #1936)
In order to adequately protect the public health, the Food and Drug Administration (FDA) must immediately require that Novartis issue a “Dear Doctor Letter” to all physicians in the U.S. that communicates the same information provided to Canadian health care professionals on October 12, 2010. In addition, the FDA should issue an alert to patients in this country similar to the October 14, 2010 alert in Canada.
[Created on 3/10/2011]

Testimony on Indacaterol Maleate (Arcapta Neohaler) (HRG Publication #1935)
In the interests of protecting the public health, the Food and Drug Administration (FDA) should not approve indacaterol at the proposed doses of 75 and 150 mcg.
[Created on 3/8/2011]

Statement: Misleading Communications Regarding Breast Implant-Related Cancer to Be Removed From Websites of Leading Plastic Surgery Organizations (HRG Publication #1934)
The Food and Drug Administration (FDA) has taken laudable action by prompting two leading plastic surgery associations to remove misleading information regarding breast implant-related cancer from the organizations’ websites.
[Created on 2/24/2011]

Letter Regarding Appropriate Classification of Electroconvulsive Therapy (ECT) Devices (HRG Publication #1933)
In order to protect the health and welfare of patients, electroconvulsive (ECT) devices should remain classified as class III, and FDA should require that rigorous, ethically justifiable clinical trials be conducted to evaluate the safety and effectiveness of ECT devices, and that data from such trials be submitted to FDA for review and evaluation under a Premarket Approval Application (PMA).
[Created on 2/24/2011]

Letter Urging Rejection of Florbetapir F18 Injection (Amyvid) (HRG Publication #1932)
The Food and Drug Administration (FDA), based on current evidence, should not approve florbetapir for the evaluation of patients suspected of having Alzheimer’s disease.
[Created on 2/21/2011]

Letter on Inaccurate Communications Regarding Risks of Breast Implant-Related Cancer (HRG Publication #1931)
A concerned plastic surgeon has just sent us portions of a transcript from a members-only webinar held on February 3, in which the presidents of the two leading plastic surgery organizations, the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS), essentially urged members to inaccurately downplay the significance of recent evidence about the risks of breast implant-related cancer when speaking to female patients.
[Created on 2/17/2011]

Letter on Liprotamase (Sollpura) (HRG Publication #1930)
These comments from Public Citizen Health Research Group are being submitted in follow-up to our testimony presented at the January 12, 2011 meeting of the Food and Drug Administration (FDA) Gastrointestinal Drug Advisory Committee regarding the drug liprotamase (Sollpura).
[Created on 1/28/2011]

Testimony on Classification of Automatic External Defibrillators (HRG Publication #1929)
In the interest of protecting public health and promoting innovation, it is imperative that FDA reject industry wishes and instead maintain the class III categorization of AEDs and require AED manufacturers to submit PMA applications.
[Created on 1/25/2011]

Statement: FDA Dodges Responsibility Regarding Medical Device Approval, Defers to IOM (HRG Publication #1928)
By deferring several important, previously proposed Food and Drug Administration (FDA) actions to a future report by the Institute of Medicine (IOM) – often because the device industry did not agree with these proposals when first issued by the FDA in August 2010 – the FDA is not being forceful enough about improving the safety and effectiveness of new devices.
[Created on 1/19/2011]

Statement: FDA’s Response to Preventable Acetaminophen Toxicity Problem is Dangerously Inadequate (HRG Publication #1927)
The measures announced today by the Food and Drug Administration (FDA) concerning acetaminophen in prescription drug products are certainly a step forward, but they entirely fail to address the greater issue of over-the-counter (OTC) use of this drug and to implement strong recommendations made by three FDA advisory committees in June 2009 about this problem.
[Created on 1/13/2011]

Testimony on Liprotamase (HRG Publication #1926)
Liprotamase, a new drug proposed to treat patients with cystic fibrosis who have problems digesting food should not be approved by the Food and Drug Administration (FDA), and further trials to determine the effectiveness of liprotamase would be unethical.
[Created on 1/12/2011]

Statement: Until Mental Health Services Are Improved, Tucson-Like Mass Murders Will Not End (HRG Publication #1925)
Until serious attention, at a national and state level, is directed at providing much better care for the seriously mentally ill and controlling the proliferation of guns, there will be many more Tucsons.
[Created on 1/11/2011]

2010

Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010 (HRG Publication #1924)
Over the past two decades, especially during the past 10 years, there has been a marked increase in both the number of government settlements with pharmaceutical companies and the size of the accompanying financial penalties.
[Created on 12/16/2010]

Statement: FDA Must Not Approve Another Dangerous Weight Loss Drug (HRG Publication #1923)
An advisory committee for the Food and Drug Administration (FDA) will weigh approval of the new weight loss drug combination bupropion and naltrexone (Contrave) today – and the agency must reject it.
[Created on 12/7/2010]

Testimony on Bupropion and Naltrexone (Contrave) Safety (HRG Publication #1922)
The new weight loss drug combination bupropion and naltrexone (Contrave) causes serious adverse events and should not be approved.
[Created on 12/7/2010]

Position Statement: Delayed FDA Removal of Painkiller Propoxyphene (Darvon, Darvocet) From U.S. Market Has Cost More Than 1,000 U.S. Lives (HRG Publication #1921)
The announcement by the U.S. Food and Drug Administration (FDA) that propoxyphene-containing products are finally going to be taken off the market – because of dangers previously known and acted upon, with bans announced in the UK almost six years ago, and in Europe, almost 1½ years ago – is a serious indictment of the FDA’s long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller.
[Created on 11/19/2010]

Testimony to IOM Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs (HRG Publication #1920A)
Dr. Wolfe testified to the Institute of Medicine (IOM) Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs.
[Created on 11/9/2010]

Position Statement: FDA’s Decision to Pull Diet Pill Meridia Commendable, But Took Too Long for Drug’s Victims (HRG Publication #1920)
The FDA’s decision today to ask pharmaceutical maker Abbott to withdraw the drug is commendable, but dangerously too late for all of the victims of its unacceptable risks.
[Created on 10/8/2010]

Comments on FDA 510(k) Medical Devices Working Group Preliminary Report and Recommendations (HRG Publication #1919)
The 510(k) premarket approval process has failed to keep dangerous and ineffective medical devices from the market as we have documented in a recent PLOS article reviewing the FDA device approval process.
[Created on 10/4/2010]

Testimony on Sibutramine (Meridia) Safety (HRG Publication #1918)
Sidney Wolfe, M.D. reviews the history of Sibutramine (Meridia) and encourages the FDA to ban the unsafe medication.
[Created on 9/15/2010]

Petition to Reduce Medical Resident Work Hours (HRG Publication #1917)
Public Citizen petitions the Occupational Safety and Health Administration (OSHA) to implement regulations for the work hours of resident physicians and subspecialty resident physicians, (i.e., medical and surgical fellows), building from the recommendations made by the Institute of Medicine in its 2009 Report, Resident Duty Hours: Enhancing Sleep, Supervision, and Safety.
[Created on 9/2/2010]

Position Statement: Study Reinforces Long-Known Dangers of Weight-Loss Drug Meridia (HRG Publication #1917A)
It is no surprise that a study published today in the New England Journal of Medicine shows that the weight loss drug Meridia increases the risk of strokes and heart attacks.
[Created on 9/1/2010]

FDA’s Partial Hold on Unethical Diabetes Drug Trial Does Not Do Enough to Protect Patients (HRG Publication #1916)
The Food and Drug Administration (FDA) has gone only half-way in stopping the unethical TIDE study by halting the recruitment of any new patients. To allow the experiment to continue at all is a major breach in the FDA’s obligation to protect people in clinical trials.
[Created on 7/21/2010]

Comments on FDA Transparency (HRG Publication #1915)
These comments focus on how the FDA should implement stronger requirements concerning pre-approval data disclosure, data disclosure for abandoned, withdrawn or denied marketing applications, more consistent post-approval review disclosure, and better affirmative disclosure practices as a way of reducing the backlog in processing Freedom of Information Act (FOIA) requests.
[Created on 7/20/2010]

Testimony on Phentermine and Topiramate (Qnexa) (HRG Publication #1914)
Sidney Wolfe, M.D. and Charles Preston, M.D., M.P.H, urge the FDA to not approve phentermine and topiramate (Qnexa) because the diet drug is unsafe.
[Created on 7/15/2010]

Testimony on Rosiglitazone (Avandia) Safety (HRG Publication #1913)
Dr. Sidney Wolfe, M.D. and David Juurlink, M.D. Ph.D, FRCPC urge the FDA to withdraw the unsafe diabetes medication rosiglitazone (Avandia).
[Created on 7/14/2010]

Article in PLoS Medicine on Breakdown of U.S. Review Process (HRG Publication #1912)
The number and complexity of medical devices have increased over the past several decades. A series of recent safety issues have raised public awareness about shortcomings in the Food and Drug Administration’s (FDA) regulation of medical devices.
[Created on 7/13/2010]

Letter on Regulation of Direct-to-Consumer Marketing (HRG Publication #1910)
Public Citizen suggests that whether a particular advertisement presents risks in a “clear, convincing and neutral” manner should be determined by techniques similar to those used to determine consumer comprehension of benefits.
[Created on 6/28/2010]

Article in BMC Medicine on Public Support of Reducing Resident Physician Work Hours (HRG Publication #1909)
Americans overwhelmingly disapprove of shifts lasting longer than 24 hours, which are currently required by teaching hospitals. This is according to new findings published in today’s edition of the online journal BMC Medicine — the first systematic study of public perceptions of resident work hours. Public Citizen contributed to the research and urges a reduction of medical resident work hours.
[Created on 6/1/2010]

Letter Urging FDA to Halt Rosiglitazone (Avandia) Trial (HRG Publication #1908)
Dr. Wolfe urges the FDA to stop the unethical Thiazolidinedione Intervention in Vitamin D Evaluation (TIDE) trial.
[Created on 5/11/2010]

Testimony on Rosiglitazone (Avandia) (HRG Publication #1907)
Dr. Wolfe explains why the TIDE study must be stopped and why Avandia should be banned.
[Created on 4/28/2010]

Guide to Avoiding Unnecessary Cesareans in New York (HRG Publication #1906)
More than 33,000 cesarean sections in New York in 2007 may have been unnecessary. Read our recommendations on how women, hospitals and medical centers can avoid these unnecessary operations.
[Created on 4/21/2010]

Ranking of State Medical Boards’ Disciplinary Actions: 2007-2009 (HRG Publication #1905)
Every year, we evaluate how well each state medical board is protecting the public by disciplining doctors. This year, Minnesota disciplined the fewest doctors and Alaska disciplined the most doctors.
[Created on 4/5/2010]

Testimony on the Cancer Risk of Calcineurin Inhibitor Skin Medications Tacrolimus (Protopic) and Pimecrolimus (Elidel) (HRG Publication #1904)
Sidney Wolfe, M.D. testified about the lymphoma risk posed to children by the ezcema medications tacrolinus (Protopic) and pimecrolimus (Elidel).
[Created on 3/22/2010]

Letter to FDA Praising Food Safety Cautiousness, Attacking Drug Safety Recklessness (HRG Publication #1903)
In contrast to becoming more active and cautious in enhancing food safety by removing potentially dangerous products before they have caused harm, several FDA decisions in the past year regarding prescription drugs can only be described as reckless.
[Created on 3/8/2010]

Article in Health Matrix: Survey of State Medical and Osteopathy Board Disciplinary Web Sites in 2006 (HRG Publication #1902)
We sought to describe doctor disciplinary information provided on the web sites of state medical and osteopathic boards. Information collected included state board, hospital and federal government actions, as well as malpractice judgments and settlements and conviction information.
[Created on 2/22/2009]

Open Letter to Executive Director of the Accreditation Council of Graduate Medical Education (ACGME) (HRG Publication #1901)
We encourage the ACGME to adopt the IOM’s resident work hour limit recommendations.
[Created on 2/4/2010]

Petition to Ban Fibromyalgia Drug Milnacipran (Savella) (HRG Publication #1900)
Milnacipran (Savella) has highly questionable clinical efficacy and has been associated with a large number of potentially serious adverse reactions including hypertension, increased heart rate and an increased incidence of suicidal ideation.
[Created on 1/19/2010]

2009

Testimony: Issues in Clinical Trials of New Drugs for Community-Acquired Bacterial Pneumonia (HRG Publication #1899)
The draft guidance under discussion clarifies several important issues regarding the appropriate design and conduct of noninferiority (NI) trials for community-acquired bacterial pneumonia (CABP).
[Created on 12/10/2009]

Petition to Ban Sibutramine (Meridia) (HRG Publication #1898)
This purpose of this letter is to re-petition the FDA to immediately ban the weight loss drug, sibutramine (Meridia & Abbott in the U.S.).
[Created on 12/2/2009]

Article in JLME: DTC Advertising Harms Patients and Should Be Tightly Regulated (HRG Publication #1897)
In an article published in the Journal of Law Medicine & Ethics, Health Research Group Deputy Director Peter Lurie evaluates direct-to-consumer (DTC) advertising and finds that the harms of DTC advertising outweigh the benefits.
[Created on 11/23/2009]

Petition Asking FDA to Reconsider Banning Propoxyphene (Darvon) (HRG Publication #1896)
This petition asks the FDA to reconsider granting our petition to ban Propoxyphene (Darvon).
[Created on 11/23/2009]

Letter Requesting That Medicare Deny Reimbursement for Transcranial Magnetic Stimulation (HRG Publication #1895)
Public Citizen asks the Center for Medicare & Medicaid Servces to deny reimbursement for TMS because the treatment has not been proved to be effective.
[Created on 11/11/2009]

Comments on FDA Draft Guidance on Postmarketing Studies and Clinical Trials (HRG Publication #1894)
Public Citizen has reviewed the draft guidance in detail and supports its purpose and approach.
[Created on 10/13/2009]

Letter Published in Biological Psychiatry: Transcranial Magnetic Stimulation Not Proven Effective (HRG Publication #1893)
Peter Lurie, M.D., M.P.H., and Eunice Yu disagree with the Reardon’s conclusion that TMS is “safe and effective in the treatment of major depression.”
[Created on 10/1/2009]

Request for a Negative National Coverage Decision for the Menaflex Collagen Scaffold Surgical Mesh for Patients With Knee Meniscus Damage (HRG Publication #1892)
We are writing to request that the Center for Medicare & Medicaid Services (CMS) issue a National Coverage Determination (NCD) that would deny Medicare reimbursement for ReGen Biologics’ Menaflex Collagen Scaffold (MCS).
[Created on 9/25/2009]

FDA Internal Review Slams Knee Device’s Approval Process (HRG Publication #1891)
Statement by Peter Lurie, M.D., M.P.H.
[Created on 9/24/2009]

Public Comments on Resident Work Hours (HRG Publication #1890)
Peter Lurie, M.D., M.P.H. and Hillary Peabody, M.P.H. testify before the Medicare Payments Advisory Commission, encouraging the Accreditation Council on Graduate Medical Education (ACGME) to implement the IOM’s recent recommendations on resident work hours.
[Created on 9/18/2009]

Hearing Highlights Dysfunction of U.S. Health Care System, Points to Need for ‘Medicare for All’ (HRG Publication #1889)
All the problems with the U.S. Health care system could be reduced or even eliminated if there was only a ‘Medicare-for-all’ system, also known as single-payer, for health care in this country.
[Created on 9/16/2009]

Letter Urging Secretary Sebelius to Provide Hospitals and Nursing Homes With Disciplinary Data on Nurses and Other Allied Health Professionals (HRG Publication #1888)
This letter urges Secretary Sebelius to immediately implement Section 1921 of the Social Security Act. This would significantly reduce the chances that patients will be injured or killed by any of the more than 100,000 non-physician health professionals (e.g., nurses, pharmacists, physician assistants) and other health workers with disciplinary records who may be employed in hospitals or nursing homes.
[Created on 8/25/2009

Have the Courage to Say Health Care Is a Right, Not a Privilege (HRG Publication #1887)
Statement by Sidney Wolfe, M.D.
[Created on 7/30/2009]

Life-Threatening Liver Toxicity of Avandia Shown in New Public Citizen Research Published in Peer-Reviewed Medical Journal (HRG Publication #1886A)
New research by Public Citizen published today in a peer-reviewed medical journal reinforces the case that the diabetes drug Avandia can cause death from liver failure and should be banned immediately by the Food and Drug Administration (FDA).
[Created on 7/22/2009]

Public Citizen’s Response to FDA Draft Guidance on Conduct of Clinical Trials in Community-Acquired Bacterial Pneumonia (HRG Publication #1886)
The Food and Drug Administration’s recent draft guidance on community-acquired bacterial pneumonia (CABP) is significant step forward from the previous draft guidance, issued in 1998. However, it includes recommendations that contradict established principles of rigorous clinical trial conduct, as defined in the International Conference on Harmonization documents E-9 and E-10, and a number of issues are left unaddressed.
[Created on 6/29/2009]

Dr. Sidney Wolfe’s Testimony Before Subcommittee on Health at Hearing on Health Insurance (HRG Publication #1885)
Sidney Wolfe, M.D., testifies about the need for a single-payer health insurance plan.
[Created on 6/24/2009]

Testimony of Peter Lurie, M.D., M.P.H. and Hillary Peabody, M.P.H. Before the FDA Transparency Task Force (HRG Publication #1883)
Dr. Lurie and Hillary Peabody testify that pre-approval documents should be made available to the public, the FDA’s Freedom of Information Act (FOIA) processes should be made more efficient and consistent, and the FDA should expedite the production of standardized drug information for patients.
[Created on 6/24/2009]

Testimony of Peter Lurie, M.D., M.P.H. and Jonas Hines on Medical Device Regulations (HRG Publication #1882)
Testimony by Peter Lurie, M.D., M.P.H. and Jonas Hines before the Subcommittee on Health Committee on Energy and Commerce, United States House of Representatives.
[Created on 6/18/2009]

Letter in Neuropsychopharmacology: Post Hoc Analysis Does Not Establish Effectiveness of rTMS for Depression (HRG Publication #1881)
Peter Lurie, M.D., M.P.H., Sidney Wolfe M.D. and Jonas Hines find fault with the analysis of the effectiveness of repetitive transcranial magnetic stimulation for treating depression.
[Created on 6/15/2009]

Letter to the Editor of The Washington Post Regarding the Coverage of the Recent Congressional Hearing on Single-Payer (HRG Publication #1880)
James Floyd M.D. describes Dana Milbank’s recent column in The Washington Post on the recent hearing on single-payer health care as polemical.
[Created on 6/15/2009]

Public Pressure Helps End Silence on Single-Payer in Congress (HRG Publication #1879)
Statement by James Floyd, M.D.
[Created on 6/11/2009]

Critique of New Antiarrhythmic Drug Dronedarone Published in the New England Journal of Medicine (HRG Publication #1878)
James Floyd M.D. criticizes the new antiarrhythmic drug dronedarone.
[Created on 6/9/2009]

Prasugrel STEMI Subgroup Analysis Published in The Lancet (HRG Publication #1877)
Letter in The Lancet faults subgroup analysis of TRITON-TIMI 38 trial comparing prasugrel with clopidogrel.
[Created on 6/3/2009]

Letter Urging the FDA to Halt its Review of Prasugrel (HRG Publication #1876)
Dr. Serebruany, Dr. Floyd and Dr. Wolfe encourage the FDA to stop its review of prasugrel until a new Phrase 3 study can be conducted with appropriate lower doses of prasugrel and properly defined outcomes.
[Created on 6/3/2009]

Testimony of James Floyd, M.D. at Meeting of Anti-Infective Drugs Advisory Committee on Cethromycin for the Treatment of Community-Acquired Bacterial Pneumonia (HRG Publication #1875)
James Floyd, M.D. testifies about the design flaws in the studies conducted on cethromycin for the Treatment of community-acquired bacterial pneumonia.
[Created on 6/2/2009]

Letter to Secretary Sebelius About National Practitioner Data Bank Deficiency (HRG Publication #1874)
Alan Levine and Dr. Sidney Wolfe present Secretary of Health and Human Services Kathleen Sebelius with a report on the deficiencies of the National Practitioner Data Bank, and urge the Secretary to meet to discuss specific recommendations for improvement.
[Created on 5/27/2009]

Hospitals Drop the Ball on Physician Oversight (HRG Publication #1873)
Lack of detection and widespread under-reporting to the National Practitioner Data Bank raise serious questions about hospital peer review.
[Created on 5/27/2009]

Testimony Before the FDA Concerning the Premarket Approval Application for Confluent’s DuraSeal Xact Sealant System for Spinal Use (HRG Publication #1872)
Dr. Lurie and Jonas Hines testify before the Neurological Devices Panel of the Medical Devices Advisory Committee, Center for Devices and Radiological Health, Food and Drug Administration, on how Confluent’s DuraSeal Xact Sealant System for Spinal Use should not be approved.
[Created on 5/14/2009]

Petition to the FDA Requesting Enhanced Warnings for Amitiza (Lubiprostone) (HRG Publication #1871)
Public Citizen petitions the Food and Drug Administration (FDA) to add a black box warning regarding the risk of abortion to the Amitzia product label, change the drug’s pregnancy category from C to X, contraindicate nursing while taking the drug, require the distribution of an FDA-approved Medication Guide for all patients, and mandate a “Dear Doctor” letter.
[Created on 5/5/2009]

Statement of Dr. Peter Lurie on FDA Granting Public Citizen’s Petition That Sought to Warn Patients and Doctors About the Dangers of Botulinum Toxin (HRG Publication #1870)
Statement by Peter Lurie, M.D., M.P.H.
[Created on 4/30/2009]

Testimony at Congressional Forum: An Examination of U.S. Health Insurance (HRG Publication #1869)
Annette B. Ramírez de Arellano, DrPH testifies about the state of U.S. Health Insurance.
[Created on 4/22/2009]

Public Citizen’s Health Research Group Ranking of the Rate of State Medical Boards’ Serious Disciplinary Actions, 2006-2008 (HRG Publication #1868)
Public Citizen uses data from the Federation of State Medical Boards to analyze the rates of serious disciplinary actions taken by state medical boards from 2005 to 2007.
[Created on 4/20/2009]

Letter to FDA Urging Rejection of Antipsychotic Drug Sertindole Because of Sudden Cardiac Death (HRG Publication #1867)
Letter from Dr. Sidney Wolfe and Dr. James Floyd recommending that the FDA not approve the dangerous antipsychotic Sertindole.
[Created on 4/9/2009]

Letter urging FDA to Reject Use of Seroquel in Depression (HRG Publication #1866)
Dr. Sidney Wolfe and Dr. James Floyd advise the FDA to not approve Seroquel for use in Major Depressive Disorder and Generalized Anxiety Disorder.
[Created on 4/9/2009]

Letter in JAMA: The Role of Tax Reform in Health Care Reform (HRG Publication #1865)
Letter in response to a 2008 Journal of the American Medical Association article by Drs. Sessions and Lee that advocates for health care reform in the form of a regressive value-added tax to finance vouchers for private health insurance.
[Created on 3/25/2009]

Letter to the Editor in The Washington Post Re: President Obama’s Effort to Reform Health Care (HRG Publication #1864)
Dr. James Floyd criticizes President Obama’s efforts to incrementally reform U.S. health care and advocates a single-payer health care system.
[Created on 3/17/2009]

Letter to FDA Commissioner About Defective Welch Allyn AEDs (HRG Publication #1863)
Public Citizen questions FDA Commissioner why a defective life-saving device continues to be marketed.
[Created on 3/13/2009]

Letter to FDA Commissioner Condemning Delayed Recall of Defective Intravenous Infusion Pumps (HRG Publication #1862)
Public Citizen criticizes the FDA for its delayed recall of a defective intravenous infusion pump that has been known for years to malfunction.
[Created on 3/12/2009]

Statement of Dr. Sidney Wolfe on the Recall of Shiley 3.0 PED Tracheostomy Tube (HRG Publication #1861)
Dr. Sidney Wolfe speaks out against the unnecessary delay by the FDA in notifying the public of this public health threat.
[Created on 3/10/2009]

Statement of Dr. Peter Lurie on Approval of SyntheMed’s REPEL-CV Bioresorbable Adhesion Barrier (HRG Publication #1860)
Peter Lurie, M.D., M.P.H., makes a statement against FDA’s approval of SyntheMed’s REPEL-CV medical device because it has not been shown to be safe or effective.
[Created on 3/9/2009]

Statement of Dr. Peter Lurie on Wall Street Journal Story Regarding Approval of ReGen Biologics’ Menaflex Collagen Scaffold Medical Device (HRG Publication #1859)
Dr. Lurie comments on an article published in the Wall Street Journal that revealed that ReGen Biologics manipulated an FDA advisory committee in order to gain FDA-approval of a medical device that does not have any discernable clinical benefit.
[Created on 3/6/2009]

Letter to the American Medical Association Supporting Ban on Commercial Support of Continuing Medical Education (HRG Publication #1858)
The Health Research Group calls for the American Medical Association to adopt a policy that would completely eliminate commercial support for physicians’ continuing medical education.
[Created on 2/23/2009]

Letter to FDA About Safety Concerns with Prasugrel Hydrochloride and Removal of Dr. Sanjay Kaul from Cardiovascular and Renal Drugs Advisory Committee Meeting (HRG Publication #1857)
Public Citizen researchers present safety and efficacy data about prasugrel hydrochloride, and recommend labeling to effectively communicate the drug’s risks (including hemorrhage and cancer) to consumers. The group also urges the removal of Dr. Sanjay Kaul from the Cardiovascular and Renal Drugs Advisory Committee meeting.
[Created on 2/19/2009]

Testimony of Sidney Wolfe Before Food and Drug Administration Advisory Committee on Propoxyphene (Darvon) (HRG Publication #1856)
Dr. Wolfe testifies before the Food and Drug Administration and advocates for a two-year phased withdrawal of these products.
[Created on 1/29/2009]

Statement of James Floyd on Public Citizen Joining Leadership Conference for Guaranteed Health Care in Support of Single Payer National Health Insurance Program (HRG Publication #1855)
Public Citizen researcher James Floyd, M.D., endorses a single payer health insurance program in the U.S. as the best solution the health care crisis in this country.
[Created on 1/28/2009]

Statement of Peter Lurie on Government Accountability Office Report on Medical Device Approval Standards (HRG Publication #1854)
Dr. Lurie comments on a Government Accountability Office report that shows the Food and Drug Administration routinely approves medical devices using lax testing standards, and points to the deficiencies of the 510(k) approval process for medical devices.
[Created on 1/15/2009]

2008

Letter to the Editor in the Sacramento Bee Re: Transcranial Magnetic Stimulation in Treating Depression (HRG Publication #1853)
Peter Lurie and Jonas Hines present evidence that disputes the value of transcranial magnetic stimulation in treating depression.
[Created on 12/19/2008]

Statement of Peter Lurie on Institute of Medicine Report on Resident Work Hours (HRG Publication #1852)
Dr. Lurie criticizes the Institute of Medicine report on resident work hours, which he says misses an opportunity to enhance patient safety by failing to better regulate the number of hours residents may work consecutively.
[Created on 12/2/2008]

Testimony Before FDA on Collagen Scaffold Medical Device (HRG Publication #1851)
The appropriate path to market for ReGen Biologic’s collagen scaffold medical device would be through the PMA process.
[Created on 11/14/2008]

Letter to Center for Devices and Radiologic Health Opposing Potential Approval of CorCap Cardiac Support Device (HRG Publication #1850)
CorCap’s “heart sock” has been repeatedly rejected by the FDA and its external advisory committees. The company is now conducting a poorly designed study that has little chance of providing convincing evidence of device safety or effectiveness.
[Created on 11/12/2008]

Letter to The New York Times Criticizing Weaknesses in FDA Oversight of Medical Devices (HRG Publication #1849)
Many medical devices in a particular category are cleared for use through a short-cut process rather than through the more formal process, despite a law requiring the FDA to eliminate this category of devices by 1995.
[Created on 10/28/2008]

Petition to Immediately Ban Diabetes Drug Rosiglitazone (AVANDIA) (HRG Publication #1848)
The Food and Drug Administration (FDA) should immediately ban the dangerous diabetes drug Avandia because it can cause death from liver failure and has many other life-threatening risks that far outweigh its benefits.
[Created on 10/30/2008]

A Tale of Three Cities: Racial and Ethnic Disparities in Premature Mortality in the District of Columbia, 2005 (HRG Publication #1847)
Public Citizen examines premature mortality in the District of Columbia versus the United States.
[Created on 10/22/2008]

Op-Ed in Atlanta Journal-Constitution About Academic Conflict of Interest (HRG Publication #1846)
Peter Lurie and Jonas Hines criticize noted Emory University Psychiatry Chair Charles Nemeroff for not fully disclosing hundreds of thousands of dollars in consulting fees.
[Created on 10/14/2008]

Testimony Before FDA Hearing on Cough and Cold Remedies for Children (HRG Publication #1845)
Public Citizen testified that the FDA was moving too slowly to get ineffective cough and cold remedies for children off the market. It also emphasized that there is no evidence for the medicines’ effectiveness for children under 11 years.
[Created on 10/2/2008]

Comments to the Department of Labor Opposing Addition of Additional Steps in Proceedings to Regulate Occupational Hazards (HRG Publication #1844)
These comments to the Department of Labor oppose the addition of a requirement for an Advanced Notice of Proposed Rulemaking (ANPRM) to the already cumbersome process for creating regulations for occupational health and safety, as it would only lengthen (but not improve) the process by which regulations are made.
[Created on 9/29/2008]

Comments On Health and Human Services’ Proposed Rule Permitting Health-Care Workers to Not Perform Abortions and Certain Other Services If It Conflicts with Their Religious Beliefs (HRG Publication #1843)
The fundamental problem with the regulation is that, by depriving patients of their right to be apprised of all the available medical options and thus to exercise their autonomy, it would allow unsuspecting patients to receive less-than-optimal medical care.
[Created on 9/25/2008]

Comments to the Accreditation Council on Continuing Medical Education (CME) Advocating a Ban on Commercial Support for CME (HRG Publication #1842)
Health Research Groups’s response to the ACCME’s proposal to ban commercial support of Continuing Medical Education (CME).
[Created on 9/12/2008]

Comments to FDA Re: Content and Format of Labeling for Human Prescription Drug and Biological Products: Requirements for Pregnancy and Lactation Labeling (HRG Publication #1841)
These comments on the FDA’s proposed pregnancy and breastfeeding labels criticize the agency for an over-emphasis on often poor human studies and an under-emphasis on animal studies.
[Created on 8/27/2008]

Petition to the FDA to Ban Ortho-Evra (HRG Publication #1840)
Public Citizen petitions the FDA to ban the patch over a 6 month period. The patch releases an increased dose of estrogen and doubles the risk of life-threatening blood clots compared to the pill without offering better protection against pregnancy.
[Created on 5/8/2008]

Cell-Free Hemoglobin-Based Blood Substitutes and Risk of Myocardial Infarction and Death (HRG Publication #1839)
Using hemoglobin as a substitute for blood has resulted in a 30% increased risk of death and a 2.7-fold increased risk of heart attack in clinical trials conducted to date.
[Created on 5/7/2008]

Comments to FDA Re: Draft Guidance for Industry on Off Label Promotion of Drugs and Medical Devices (HRG Publication #1838)
Public Citizen submits comments on the Draft Guidance for industry that would regulate off label promotion of drugs and medical devices.
[Created on 4/21/2008]

Public Citizen’s Health Research Group Ranking of the Rate of State Medical Boards’ Serious Disciplinary Actions, 2005-2007 (HRG Publication #1837)
Public Citizen uses data from the Federation of State Medical Boards to analyze the rates of serious disciplinary actions taken by state medical boards from 2005 to 2007.
[Created on 4/21/2008]

Letter Criticizing an FDA Proposed Rule Restricting the Ability of Drug Companies to Add Safety Warnings to Their Products’ Labels Without Prior FDA Approval (HRG Publication #1836)
The agency has failed to demonstrate a need for revising this regulation. We urge the FDA to withdraw this ill-considered proposal.
[Created on 3/17/2008]

Testimony Before the Congressional Agriculture-FDA Appropriations Subcommittee Hearing on Drug Safety (HRG Publication #1835)
This committee needs to police the relatively toothless FDA and its budget more effectively.
[Created on 2/27/2008]

Petition to the FDA Requesting Regulatory Action Concerning the Possible Spread of Botulinum Toxin (Botox, Myobloc) From the Site of Injection to Other Parts of the Body (HRG Publication #1834)
The manufacturers of botulinum toxin should issue warning letters to physicians, create patient medication guides to be distributed to all patients and improve label warnings to stress the possibility of dysphagia and aspiration.
[Created on 1/23/2008]

2007

Comments on FDA’s Draft Guidance for Industry – Drug-Induced Liver Injury: Premarketing Clinical Evaluation (HRG Publication #1833)
The FDA’s guidance document confirms the agency’s continued reluctance to seriously and publicly engage in post-mortem analyses of the growing number of mistakes the FDA has made concerning failed decision-making about either the approval of known hepatotoxic drugs or the dangerously delayed removal of ones showing hepatotoxicity shortly after approval.
[Created on 12/28/2007]

Comments on the Draft Report on the U.S. System of Oversight of Genetic Testing (HRG Publication #1832)
The seriousness of mistaken results in genetic testing is so grave that oversight cannot be entrusted to self-interested parties or voluntary efforts by lackluster federal agencies.
[Created on 12/26/2007]

Letter to the FDA Urging Against Approval of Cardiac Device REPEL-CV (HRG Publication #1831)
Public Citizen urges the Food and Drug Administration (FDA) to deny approval to SyntheMed’s REPEL-CV, a device to reduce cardiac adhesions (abnormal scar tissue formation in which surfaces normally separate adhere to each other) from surgery, because the device has not demonstrated a “reasonable assurance that the device is safe and effective,” the standard necessary for approval under the law.
[Created on 12/21/2007]

Presentation Before the Institute of Medicine Committee on Conflict of Interest in Medical Research, Education and Practice (HRG Publication #1830)
Disclosure is no substitute for prevention of conflicts when this is feasible and legal. Financial conflicts are of particular concern and merit specific attention. This committee could play a helpful role in delineating how future research should be conducted.
[Created on 12/14/2007]

Testimony on the Public Health Dangers of Making Lovastatin (Mevacor) Available Over-the-Counter (HRG Publication #1829)
We strongly oppose the switch of lovastatin or any other statin to OTC status. With each look at the latest evidence, the case against such a switch becomes clearer.
[Created on 12/13/2007]

Testimony of Sidney M. Wolfe M.D. on Behind-the-Counter Availability of Certain Drugs (HRG Publication #1828)
Dr. Wolfe testifies about the benefits and risks of approving availability of certain drugs behind-the-counter.
[Created on 11/14/2007]

Comments Before an FDA Advisory Committee on the Availability of Over-the-Counter Pediatric Cough and Cold Formulations (HRG Publication #1827)
All dosage forms such as droppers or syringes intended for children should be removed from the market; all remaining products should be clearly labeled to say that the products have not been shown to work in children and may be dangerous; and the definition of “children” should be those up to 12 years of age.
[Created on 10/19/2007]

Letter to the FDA Urging an Investigation of Medtronic Defibrillator Recall (HRG Publication #1826)
The congratulatory comments by both the FDA and Medtronic have covered up the FDA’s failure to stop Medtronic’s outrageous and irresponsible Medtronic direct-to-consumer ad campaign.
[Created on 10/16/2007]

Letter to the FDA Urging Action Against a Campaign Promoting the Unapproved Use of Topamax for Treating Alcoholics (HRG Publication #1825)
The FDA should stop an illegal and dangerous promotional campaign for the unapproved use of Topamax (topiramate) for treating alcoholics.
[Created on 10/9/2007]

Testimony Before the FDA Circulatory Systems Devices Panel Meeting on the Resorbable Adhesion Barrier REPEL-CV (HRG Publication #1824)
Testimony of Peter Lurie, M.D., M.P.H. and Eunice Yu in Gaithersburg, MD on September 19, 2007 urging the FDA not to approve this device.
[Created on 9/19/2007]

Follow-Up Letter to the Department of Labor About the Artificial Butter Flavor Chemical Diacetyl (HRG Publication #1823)
This follow-up letter serves to report several important developments concerning the serious adverse health risks associated with exposure to diacetyl, and to renew our call for emergency action to protect workers.
[Created on 9/7/2007]

Report: Equal Pay for Equal Work? Not for Medicaid Doctors (HRG Publication #1822)
In order to ascertain what Medicaid and Medicare providers earn for specific primary care-related services in given states, we computed the current (2007) Medicare fees for 10 states and the District of Columbia, and compared them with the corresponding fees under Medicaid.
[Created on 9/5/2007]

Testimony Before the Senate Judiciary Committee on Oxycontin and the Prosecution of Purdue (HRG Publication #1821)
Employees of Purdue orchestrated an illegal scheme to promote Oxycontin as being safer, more effective and less subject to abuse than it actually was and pushed hundreds of millions of prescriptions for the drug based on the false pretenses of their promotional campaigns.
[Created on 7/31/2007]

Testimony Before the FDA Advisory Committee Meeting on Rosiglitazone (HRG Publication #1820)
There is no evidence of any uniquely beneficial clinical outcome for Avandia and growing evidence in multiple organ systems (cardiac, liver, bone, bone marrow) of unique risks. Therefore, its overall risk-benefit profile does not support its continued marketing in the US.
[Created on 7/30/2007]

A Policy Study of Clinical Trial Registries and Results Databases (HRG Publication #1819)
All of the currently available clinical trial registries and results databases are inadequate. In order to realize all the purposes of clinical trial registries and results databases, there must be strong federal legislation.
[Created on 7/17/2007]

Letter Urging That Rimonabant and Etoricoxib Be Removed From the European Market (HRG Publication #1818)
We hope that the EMEA will reconsider their stance on etoricoxib and rimonabant and we strongly urge that these two drugs be promptly removed from the market.
[Created on 7/16/2007]

Testimony on State Laws Requiring Disclosure of Pharmaceutical Company Payments to Physicians (HRG Publication #1817)
All existing state physician payment disclosure laws are deficient in at least one significant respect. Due these deficiencies and lax enforcement of the laws, payments are likely substantially underestimated.
[Created on 6/27/2007]

Petition to Require That Certain Advisory Committee Meetings Include an FDA Staff Presentation (HRG Publication #1816)
All future advisory committee meetings discussing specific products should include an oral scientific presentation by FDA staff on the products reviewed, including a thorough safety and efficacy assessment.
[Created on 6/21/2007]

Testimony Before FDA Advisory Committee Meeting on Rimonabant (HRG Publication #1815)
The FDA should not approve rimonabant because serious safety questions have been raised and more rigorous studies of safety and efficacy are needed.
[Created on 6/13/2007]

Letter About Ethical Concerns With Hepatitis E Vaccine Trial in the New England Journal of Medicine (HRG Publication #1814)

Peter Lurie and Sanjay Basu criticize the hepatitis E virus (HEV) vaccine trial in Nepal on ethical grounds.
[Created on 6/7/2007]

Ranking of the Rate of State Medical Boards’ Serious Disciplinary Actions, 2004-2006 (HRG Publication #1813)
This report ranks each state’s medical board based on serious disciplinary actions taken against doctors in the past 3 years.
[Created on 6/5/2007]

Letter Demonstrating That the FDA Knew About Avandia Dangers, Urging Action (HRG Publication #1812)
An FDA memo sent in 2002 recommends stronger warnings on Avandia, but those warnings were ignored. The FDA should at least label the drug as a last choice treatment and require a black box warning about the risks to the heart.
[Created on 5/22/2007]

Testimony on Programs Affecting Safety and Innovation in Pediatric Therapies (HRG Publication #1811)
Many drugs and medical devices are not adequately tested in children, in part because Congress does not give the FDA enough power to require pediatric studies.
[Created on 5/22/2007]

Testimony Regarding Texas SB 308, Syringe Exchange Programs (HRG Publication #1805)
This bill is in the very mainstream of public health practice; every single federally funded comprehensive review of needle exchanges has endorsed the programs as being effective. Needle exchange programs do not represent a surrender in the war on drugs. They represent a recognition that, whether we like it or not, some people do continue to inject, and that such people are entitled to public health services like everyone else in this country.
[Created on 5/14/2007]

Letter to Congress Regarding Prescription Drug User Fee Act (PDUFA) (HRG Publication #1810)
We are writing to express our opposition to the reauthorization of the Prescription Drug User Fee Act (PDUFA).
[Created on 5/4/2007]

Comments on a Draft of the Safe Drug Compounding Act of 2007 (HRG Publication #1809)
Legislation should clearly define legitimate traditional pharmacy compounding while protecting the public from unsafe compounding practices.
[Created on 5/1/2007]

Comments on FDA Obesity Trial Guidelines (HRG Publication #1808)
We hope that the revised FDA guidelines on clinical trials for obesity drugs will include a requirement that will finally provide information on the long-term effects of these drugs on morbidity and mortality.
[Created on 4/19/2007]

Unsettling Scores: A Ranking of State Medicaid Programs, 2007 (HRG Publication #1807)
This report ranks state Medicaid programs and provides state-specific summaries with the breakdown of scores by category. This allows states to pinpoint their areas of weakness, and to more successfully target their interventions. It also highlights states that have achieved success in one or more areas and can therefore serve as models for other jurisdictions.
[Created on 4/17/2007]

Testimony Before the FDA Arthritis Advisory Committee Concerning Arcoxia (HRG Publication #1806)
In addition to strongly urging your committee and the FDA to reject Merck’s effort to approve etoricoxib in the U.S, I urge prompt removal of Arcoxia from the market in the 60+ countries where it is causing unacceptable risks to the hundreds of thousands of people using the drug.
[Created on 4/12/2007]

Letter to CIOMS Regarding the Draft Document Special Ethical Considerations for Epidemiological Research (HRG Publication #1804)
This letter to the Council for International Organizations of Medical Sciences identifies some elements missing from the draft document of the document Special Ethical Considerations for Epidemiological Research and then offers some comments on particular guidelines.
[Created on 4/10/2007]

Letter to the FDA Concerning Pfizer’s 2 ½ Minute Television Advertisement for Celebrex (HRG Publication #1803)
We urge the Food and Drug Administration to order Pfizer to immediately stop its dangerous, misleading 2 ½ minute television advertisement for Celebrex that began airing on April 2nd.
[Created on 4/9/2007]

Description of Efforts to Redesign Surfactant (Surfaxin) Study in Latin America (HRG Publication #1802)
An unethical placebo-controlled drug trial in Latin America was redesigned following a campaign by Public Citizen. In 2001, Discovery Laboratories Inc. of Doylestown, Penn. redesigned its study of Surfaxin, its brand of surfactant, after effective pressure from Public Citizen.
[Created on 4/2/2007]

Article in JAMA: Pharmaceutical Company Payments to Physicians (HRG Publication #1801)
Early Experiences With Disclosure Laws in Vermont and Minnesota.
[Created on 3/20/2007]

Comments to the FDA: Access to and Charging for Investigational Drugs (HRG Publication #1800)
Comments by Peter Lurie, M.D., M.P.H, Allison Zieve, J.D. and Sidney M. Wolfe, M.D.
[Created on 3/19/2007]

Petition to the FDA to Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis (HRG Publication #1799)
It is estimated that women in the U.S. filled more than 7.5 million prescriptions for third generation oral contraceptives this past year (November 2005 to October 2006) (IMS, National Prescription Audit). By banning third generation oral contraceptives, the FDA will potentially save hundreds of young women a year from developing venous thrombosis and its disabling and sometimes fatal consequences.
[Created on 2/6/2007]

Comments on Joint Commission’s Draft 2008 Patient Safety Goal on Health Care Worker Fatigue (HRG Publication #1798)
Public Citizen presents evidence of health care worker fatigue and encourages the Joint Commission on Accreditation of Health Care Organizations (JCAHO) to strengthen its draft Patient Safety Goal on resident work hour regulations.
[Created on 1/26/2007]

Testimony at Meeting on Repetitive Transcranial Magnetic Stimulation, Duraseal and Vagus Nerve Stimulation (HRG Publication #1797)
Testimony by Peter Lurie, M.D., M.P.H. and Sylvia Park, M.D., M.P.H.
[Created on 1/26/2007]

2006

Letter in The Lancet: Suboptimum Use of FDA Drug Advisory Committees (HRG Publication #1796)
A declining minority of products faces advisory committees, the FDA frequently elects not to present its own interpretations of the sponsor’s data, and the rate of inconsistency between advisory committee recommendations and subsequent FDA actions is higher than is generally assumed.
[Created on 12/23/2006]

Testimony Before FDA Advisory Committee Concerning the Protocol for Biopure’s Blood Substitute HBOC-201 (HRG Publication #1795)
Testimony by Sidney Wolfe, M.D.
[Created on 12/14/2006]

Trials of Prophylaxis to Prevent Recurrent Herpes Should Not Utilize a Placebo Arm (HRG Publication #1794)
Researchers of this study placed their patients at higher risk unnecessarily in a study where valacyclovir was administered to pregnant women with a history of genital herpes simplex virus (HSV).
[Created on 12/1/2006]

Description of a Research-Based Health Activism Curriculum for Medical Students (HRG Publication #1793)
We designed a 1-month curriculum in research-based health activism to develop physician activists. The annual curriculum includes a student project and 4 course sections; health policy, research methods, advocacy, and physician activists as role models.
[Created on 11/14/2006]

Letter to JOEM: Lung Cancer Mortality in the German Chromate Industry (HRG Publication #1792)
The Birk et al article requires further consideration for the following reasons 1) these data were withheld from a federal rulemaking proceeding, 2) these data were actually part of a larger study that refutes the authors’ conclusion, and 3) after examining the study, the U.S. Occupational Safety and Health Administration (OSHA) rejected the authors’ conclusion.
[Created on 11/3/2006]

Report of Doctor Disciplinary Information on State Web Sites 2006 (HRG Publication #1791)
Report by Meredith Larson, Benita Marcus, Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 10/16/2006]

Public Citizen Calls for Criminal Investigation of Breast Implant Manufacturer for Withholding Safety Data From FDA (HRG Publication #1790)
A former senior scientist from a company seeking FDA approval of silicone gel breast implants sent a letter to the FDA accusing the company of withholding important new safety information concerning dangerous physical and chemical properties of their implants. No approval decision on implants should be made until the FDA is in possession of and has evaluated these new studies.
[Created on 10/11/2006]

Article in Law and Contemporary Problems: Access to Pharmaceutical Data at the FDA (HRG Publication #1789)
Advocates of greater corporate involvement in clinical science argue that the public benefits from the more rapid movement of beneficial products into commerce, but progress in science is based on the free publication of study results and on the public release of data. In contrast, the governing ethic in the corporate sector is secrecy — the withholding of any information from which a competitor might benefit.
[Created on 10/10/2006]

Letter to Biological Psychiatry Responding to Three Articles Regarding Vagus Nerve Stimulation (VNS) for Depression (HRG Publication #1788)
It is disturbing that the FDA considers unconvincing data adequate grounds for approving a new device, particularly when it would never approve a drug for depression on these grounds. We recommend that physicians take the gross inadequacy of these data into account before prescribing VNS to their patients.
[Created on 10/9/2006]

Petition Requesting a Genetic Testing Specialty and Standards for Proficiency Testing (HRG Publication #1787)
The Genetics and Public Policy Center, Public Citizen’s Health Research Group, and Genetic Alliance request that the Centers for Medicare and Medicaid Services (CMS) implement the Clinical Laboratory Improvement Amendments of 1988 (CLIA) by creating a genetic testing specialty and establishing standards for proficiency testing.
[Created on 9/26/2006]

New Jersey Senate Testimony Regarding Needle Exchange Programs (HRG Publication #1786)
We must tailor our efforts to reach all sectors of the at-risk community by reaching out to drug users who cannot or will not stop injecting drugs in the near future. We must have an array of outlets for such persons to obtain syringes; both needle exchanges and pharmacy availability are critical.
[Created on 9/19/2006]

Hexavalent Chromium Standard Falls Short: Compliance Magazine Article (HRG Publication #1785)
In 2006, OSHA raised the permissible exposure limit (PEL) of hexavalent chromium, a lung carcinogen, to 5 ug/m3. The agency itself estimates 10 to 45 lung cancer deaths per 1,000 workers over a working lifetime at this PEL, far in excess of what it has permitted in any previous standard. Public Citizen sued the agency for change.
[Created on 9/15/2006]

Letter Requesting That Medicare Deny Reimbursement for Cyberonics’ Vagus Nerve Stimulation Device for Treatment-Resistant Depression (HRG Publication #1784)
There are no convincing data of the Vagus Nerve Stimulation device’s effectiveness, let alone that it is “reasonable and necessary.” To reimburse for an ineffective device (and an expensive, surgically implanted one at that) does no favors for those suffering from treatment-resistant depression.
[Created on 9/6/2006]

Petition to the FDA to Reverse the Approval of the Vagus Nerve Stimulation Device for the Management of Treatment-Resistant Depression (HRG Publication #1783)
In approving VNS, the FDA overruled the more than twenty FDA officials who had reviewed the data. A Senate Finance Committe report questions the appropriateness of FDA’s approval, concluding that “instead of relying on the comprehensive scientific evaluation of its scientists and medical officers, it appears that the FDA lowered its threshold for evidence of effectiveness.”
[Created on 9/6/2006]

U.S. Physicians Disciplined For Criminal Activity (HRG Publication #1782)
Physicians disciplined by states and federal agencies for infractions related to criminal conduct between 1990 and 1999 often escaped with a slap on the wrist, and many are practicing today, according to a Public Citizen study published in the current issue of Health Matrix, a publication of Case Western Reserve University School of Law.
[Created on 8/30/2006]

Public Citizen Petitions the FDA to Include a Black Box Warning on Fluoroquinolone Antibiotics (HRG Publication #1781)
Public Citizen, representing more than 100,000 consumers nationwide, hereby petitions the Food and Drug Administration (FDA), pursuant to the Federal Food, Drug and Cosmetic Act 21 U.S.C. Section 355(e)(3), and 21 C.F.R. 10.30, to immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States.
[Created on 8/29/2006]

The US FDA at a Crossroads (HRG Publication #1780)
Peter Lurie suggests four reforms for the Food and Drug Administration as the agency enters its second 100 years.
[Created on 8/24/2006]

Health Care Reform in the United States: Arguments for a Single Payer System (HRG Publication #1778)
Public Citizen’s Health Research Group submitted the following statement to the Citizens’ Health Care Group as part of a two-year federally mandated and funded process that produced The Health Report to the American People as well as Interim Recommendations on which they requested comments.
[Created on 7/28/2006]

Letter to FDA Commissioner Requesting Enforcement Against Maker of Nicotine Beverages (HRG Publication #1777)
Public Citizen and the Campaign for Tobacco-Free Kids requests that the FDA enforces regulations that would ban nicotine beverages such as NICLite. These beverages contain the equivalent of two cigarettes’ worth of nicotine. They are being illegally marketed as “dietary supplements,” even though the FDA has made it clear that they are drugs that have never been approved by the agency.
[Created on 7/10/2006]

The 100th Anniversary of the FDA: The Sleeping Watchdog Whose Master is Increasingly the Regulated Industries (HRG Publication #1776)
As we celebrate the 100th anniversary of this important agency, there are too many instances in which the FDA appears to be reverting back to the days when industry was unregulated and companies did as they pleased, rather than into the 21st century.
[Created on 6/27/2006]

Letter to FDA to Stop Five Companies From Illegally Promoting Low-Power Laser Therapy as a Means to Quit Smoking (HRG Publication #1775)
The clinics, Freedom Laser Therapy Inc., the Anne Penman Laser Therapy clinics, New Beginnings Laser Therapy, Laser Concept and the Stop Smoking Laser Center, are marketing laser therapy as a safe and effective smoking cessation treatment despite the lack of FDA clearance or any evidence that it is effective.
[Created on 6/22/2006]

Update on Use of Growth Hormone for Normal Small Children: Discussed on CNN International June 20, 2006 (HRG Publication #1774)
Since HRG testified against the approval of growth hormone for small normal children at an FDA hearing three years ago, additional information confirming the concerns we expressed is now available.
[Created on 6/20/2006]

Statement Before the Institute of Medicine Committee on Developing Cancer Biomarkers: A Case Study Involving ACF/Orlistat (HRG Publication #1773)
This presentation argued that it is quite important to look for early animal evidence of chemically-induced cancer, as a biomarker for cancer development. The main focus on biomarkers has been for screening, early diagnosis and success of treatment of cancer. The standard of evidence for these latter uses of biomarkers should be more rigid than that for biomarkers used to predict harm from chemicals such as drugs.
[Created on 6/15/2006]

Letter to Institute of Medicine Criticizing Their Recent Report on Sleep Disorders for Failure to Address the Issue of Resident Work Hours (HRG Publication #1772)
A major public health opportunity is missed by the Institute of Medicine (IOM): the failure to include any public policy recommendation regarding resident work hours in the IOM’s recent report on sleep disorders and deprivation. Moreover, the committee suffered from undeclared conflicts of interest, raising the possibility that these conflicts were partly responsible for the glaring omission of residency work hour reform from the report.
[Created on 6/9/2006]

Supplement to Petition to Ban Diet Drug Orlistat (Xenical). Additional Information Provided About Pre-Cancerous Changes to the Colon (HRG Publication #1771)
Four researchers objected to the fact that FDA advisory committee members who met on January 23rd to consider the over-the-counter switch of orlistat were not informed at or prior to the meeting about pre-cancerous changes (aberrant crypt foci or ACF) induced by orlistat in the colon of animals, an outcome documented in two studies. There is more than enough evidence to take orlistat off the market as a prescription drug and thereby end the process of switching it to over-the-counter status.
[Created on 6/5/2006]

Letter to FDA Requesting the Immediate Halt of Cyberonics Ads for Vagus Nerve Stimulation Devices (HRG Publication #1770)
Public Citizen today submitted a letter to the Food and Drug Administration (FDA) urging the FDA to tell the company Cyberonics to immediately withdraw its advertisement for the vagus nerve stimulation (VNS) device currently running on the WebMD Website and to run a corrective advertisement. The advertisement makes a series of claims greatly exaggerating the findings from VNS clinical studies and includes at least 10 violations of FDA laws and regulations.
[Created on 5/18/2006]

Testimony Before FDA Advisory Committee on Rivastigmine (Exelon) for Dementia Associated With Parkinson’s Disease (HRG Publication #1769)
Testimony by Peter Lurie, M.D., M.P.H. and Elizabeth Barbehenn, Ph.D.
[Created on 5/17/2006]

Petition to the FDA to Immediately Ban the Antibiotic Gatifloxacin (Tequin) (HRG Publication #1768)
Petition by Joseph Baker, M.D., M.P.H., Sidney Wolfe, M.D. and Peter Lurie, M.D., M.P.H.
[Created on 5/1/2006]

Comments to the New Zealand Ministry of Health on Direct-to-Consumer Advertising of Prescription Drugs (HRG Publication #1767)
Comments by Peter Lurie, M.D., M.P.H.
[Created on 4/28/2006]

Ranking of State Medical Board Serious Disciplinary Actions: 2003-2005 (HRG Publication #1766)
Report by Sidney M. Wolfe, M.D., Peter Lurie, M.D., M.P.H., Benita Marcus and Meredith Larson
[Created on 4/26/2006]

Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings (HRG Publication #1765)
Disclosures of conflicts of interest at drug advisory committee meetings are common, often of considerable monetary value, and rarely result in recusal of advisory committee members. A weak relationship between certain types of conflicts and voting behaviors was detected, but excluding advisory committee members and voting consultants with conflicts would not have altered the overall vote outcome at any meeting studied.
[Created on 4/25/2006]

Petition to the FDA to Immediately Remove the Diet Drug Orlistat (Xenical) From the Market (HRG Publication #1764)
This drug, which treats obesity, causes a significant increase in the incidence of aberrant crypt foci, which are widely believed to be a precursor of colon cancer.
[Created on 4/10/2006]

Comments to the FDA on Good Manufacturing Practices for Phase I Clinical Drug Trials (HRG Publication #1763)
Comments by Peter Lurie, M.D., M.P.H. and Sidney M. Wolfe, M.D.
[Created on 4/3/2006]

Petition to FDA to Ban All Propoxyphene (Darvon) Products; Prescription Painkiller Causes Many Fatalities (HRG Publication #1762)
Petition by Sidney M. Wolfe, M.D., Dan Suzman, Ulf Jonasson, Dr.PH and Birgitta Jonasson, Ph.D.
[Created on 2/28/2006]

Selected Science: an Industry Campaign to Undermine an OSHA Hexavalent Chromium Standard (HRG Publication #1761)
Industry withheld key data from OSHA and manipulated them; secret research supported strict standard for workplace exposure to Hexavalent Chromium.
[Created on 2/24/2006]

Testimony Before the FDA Advisory Committees on Possible Switch of Orlistat (Xenical) to OTC Status (HRG Publication #1760)
The switch of orlistat to OTC status would be a serious, dangerous mistake in light of its marginal benefits, frequent co-existence of other diseases, common, bothersome G-I adverse reactions, significant inhibition of absorption of fat soluble vitamins, and problematic use in the millions of people using warfarin.
[Created on 1/23/2006]

Statement Before the Institute of Medicine Committee Assessing the U.S. Drug Safety System (HRG Publication #1759)
Following are 13 cases of prescription drugs in which serious mistakes have been made by the FDA, leading to large numbers of avoidable deaths and injuries. A critical part of improving the system for drug safety is remembering, admitting and learning from past mistakes. The FDA appears largely incapable of doing so.
[Created on 1/19/2006]

2005

Widespread Drug Marketing Violations Occurred at American Psychiatric Association Convention, Public Citizen Writes in Journal of Public Health Policy (HRG Publication #1779)
More than half the drug makers that participated in the 2002 American Psychiatric Association (APA) convention violated drug marketing rules set up by the association or the Food and Drug Administration (FDA), Public Citizen writes in a study in the current issue of The Journal of Public Health Policy.
[Created on 12/15/2005]

Statement by Sidney Wolfe, M.D., at the Public Hearing on CDER’s Current Risk Communication Strategies for Human Drugs (HRG Publication #1758)
George Santayana is frequently remembered for his statement that those who cannot remember the past are condemned to repeat it. The FDA will inevitably continue to repeat the kind of mistakes that a careful post-mortem examination and course correction would have prevented.
[Created on 12/7/2005]

Comments of Sidney Wolfe, M.D. at Meeting With Acting FDA Commissioner Andrew von Eschenbach , M.D. Concerning Silicone Gel Breast Implants (HRG Publication #1757)
Comments by Sidney Wolfe, M.D.
[Created on 12/6/2005]

Letter to FDA Urging that the Diabetes Drug Muraglitazar (Pargluva) Not Be Approved Because of an Increased Risk of Serious Adverse Reactions Including Death (HRG Publication #1756)
We are writing to expand upon our concerns regarding the possible approval of the diabetes drug muraglitazar (Pargluva), a drug with no proven benefit on cardiovascular end points but with a demonstrated unique toxicity profile. Based upon currently available data, muraglitazar should not be approved.
[Created on 11/21/2005]

Hexavalent Chromium Study’s Conclusions Unjustified (HRG Publication #1755)
Letter to the Editor appearing in the Journal of Occupational and Environmental Medicine.
[Created on 10/10/2005]

Letter to FDA Urging the Immediate Recall of All Outstanding Supplies of Generic Pemoline From the Market (HRG Publication #1754)
It is reckless and insensitive to the health and lives of children and adults using this drug for the FDA and the involved drug companies to fail to institute an immediate recall of these dangerous products. Otherwise, when the next case of liver damage, fatal or otherwise, occurs, the parents and other relatives of the drug’s victim will ask the government and the companies, “Why did you allow this to happen?”
[Created on 10/24/2005]

Petition to the FDA to Require a Black Box Warning for Erectile Dysfunction Drugs (Viagra, Cialis, Levitra) to Warn of the Potential for Irreversible Vision Loss (HRG Publication #1753)
The number of cases of ischemic optic neuropathy (usually resulting in blindness) per million prescriptions is 18-fold higher for patients taking Viagra compared with patients taking Lipitor, another drug used by people with similar risk factors.
[Created on 10/20/2005]

Misleading Data Analyses in Salmeterol (SMART) Study (HRG Publication #1752)
These documents provide insight into the manner in which the company manipulated the data it submitted to the FDA in an apparent attempt to convince the agency that the drug’s risks were smaller.
[Created on 10/8/2005]

Testimony Before the Senate Special Committee on Aging on the Impact of Direct-to-Consumer Drug Advertising on Seniors’ Health and Health Care Costs (HRG Publication #1751)
DTC advertising is nothing less than an end-run around the doctor-patient relationship – an attempt to turn patients into the agents of pharmaceutical companies as they pressure physicians for medications they may not need.
[Created on 9/29/2005]

Letter to Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, Requesting New Device Regulation (HRG Publication # 1750)
Letter by Rachel Roisman, M.D. and Peter Lurie, M.D., M.P.H.
[Created on 9/14/2005]

Testimony Before FDA Advisory Committee on New Diabetes Drug Muraglitazar (Pargluva): Risks Outweigh the Benefits. (HRG Publication #1749)
Muraglitazar is a drug with modest ability to reduce hemoglobin A1C, but no proven ability to reduce the micro- and macrovascular complications that are the real concern in diabetes management.
[Created on 9/9/2005]

FDA Denial of Public Citizen’s Petition to Ban Meridia Is Misguided (HRG Publication #1748)
Although there was a 60 percent decrease in prescriptions filled for this drug in the United States between 2001 (1.7 million prescriptions filled) and 2004 (670,000 prescriptions filled), many people are still getting this dangerous but not very effective drug that we have warned people not to use since 2001 and petitioned the FDA to ban in 2002.
[Created on 8/17/2005]

Statement of Sidney Wolfe, M.D., Regarding Petitions to Block FDA Approval of Silicone Gel Breast Implants (HRG Publication #1747)
HRG considers possible legal action – filing a lawsuit to challenge what plainly would be an unlawful, arbitrary and capricious agency action.
[Created on 8/9/2005]

Letter to FDA Concerning FDA-Approved Medication Guides (HRG Publication #1746)
Public Citizen estimates that there are only about 75 drugs that are required to be dispensed with FDA-approved Medication Guides. The FDA should long ago have required such for the thousands of other FDA-approved drugs after the private sector vendors failed in 2001 to provide consumers with any useful drug information.
[Created on 7/25/2005]

Letter to FDA Supporting the Strengthening of the Open Public Hearing as Part of FDA Advisory Committee Meetings (HRG Publication #1745)
Suggested improvements include: calling on the FDA to require disclosure of any financial conflict of interest for all OPH speakers, permit members and voting consultants to question speakers about the nature of their conflict, screen presentation descriptions submitted by potential OPH speakers and exclude those that are clearly off-topic or are blatantly advertising and allot a minimum of five minutes for each OPH presentation.
[Created on 6/15/2005]

Letter Opposing U.S. Government Efforts to Declare Some Foreign Ethics Approval Procedures Equivalent to Those in the U.S. (HRG Publication #1744)
Letter by Peter Lurie, M.D., M.P.H. and Sidney M. Wolfe, M.D.
[Created on 5/31/2005]

Testimony Before the Committee on Health Hearing on the Performance of the DC Board of Medicine (HRG Publication #1743)
Testimony by Sidney M. Wolfe, M.D.
[Created on 5/23/2005]

Testimony Before FDA Public Meeting on Levothyroxine Sodium Therapeutic Equivalence (HRG Publication #1742)
This hearing is simply the latest round in a decades-long debate in which discredited scientific arguments are repeated and uncorroborated clinical anecdotes recycled in an effort to generate enough confusion to maintain the market share of the brand name medication, Synthroid, and, to a lesser extent, Levoxyl.
[Created on 5/23/2005]

Letter to FDA Urging That the Vagus Nerve Stimulator Not Be Approved for Treatment of Depression (HRG Publication #1741)
Effectiveness of Vagus Nerve Stimulation Therapy Unproved, Safety Questionable.
[Created on 5/11/2005]

Drugs and Breastfeeding—a Letter to the Editor of Australian Prescriber (HRG Publication #1740)
This is a letter to the Editor of Australian Prescriber concerning a review of a book (Drugs and Breastfeeding) that stated that metronidazole (Flagyl) ‘will do the baby no harm’. On the contrary, there is tremendous potential for harm and the US product information actually says not to nurse when using metronidazole. So much for the usefulness of this book!
[Created on 5/9/2005]

Supplement to Petition to the FDA to Withdraw the Lung Cancer Drug Gefitinib (Iressa) From the Market (HRG Publication #1739)
This is a supplement to Petition to the FDA to withdraw the lung cancer drug gefitinib (Iressa) because of a newly available government-sponsored clinical trial that brings to four the number of studies in which Iressa has failed to reduce mortality.
[Created on 4/28/2005]

Post-Hearing Comments on OSHA’s Proposed Hexavalent Chromium Rule (HRG Publication #1738)
Comments by Altoon Dweck, M.D., Scott L. Nelson and Peter Lurie, M.D., M.P.H.
[Created on 4/20/2005]

Ranking of the Rate of State Medical Boards’ Serious Disciplinary Actions: 2002-2004 (HRG Publication #1737)
Report by Sidney M. Wolfe, M.D. and Peter Lurie, M.D., M.P.H.
[Created on 4/19/2005]

Statement by Sidney M. Wolfe, M.D. at FDA Hearing on Silicone Gel Breast Implants (HRG Publication #1736)
Statement by Sidney M. Wolfe, M.D.
[Created on 4/12/2005]

Comments Submitted on FDA Guidance for Industry on Clinical Lactation Studies (HRG Publication #1735)
If a drug has the potential to harm a nursing infant, the mother should be informed of those harms, both long and short term, and base her decision on whether to nurse on all information available. Much current advice ignores or downplays toxicity, even information available in the drug’s label, as if breast-feeding per se were the overarching consideration to be done at almost any cost to the future health of the child.
[Created on 4/11/2005]

Bextra Ban a Good Step, but FDA Should Pull Celebrex Too (HRG Publication #1734)
Bextra is the tenth prescription drug to be taken off the market in the past seven years that Public Citizen had previously warned consumers not to use. For four of the drugs – Vioxx, Baycol, Rezulin and Serzone – Public Citizen issued warnings more than two years before their removal from the market.
[Created on 4/7/2005]

Statin-Associated Rhabdomyolysis (HRG Publication #1733)
Letter to the editor that appeared in the April 2005 issue of Pharmacoepidemiology and Drug Safety. Statin-induced rhabdomyolysis (muscle destruction) with the currently available statins typically occurs after long periods of event-free use, underscoring the need for active vigilance by clinicians.
[Created on 4/5/2005]

U.S. Exceptionalism Comes to Research Ethics – Comment by Peter Lurie in The Lancet (HRG Publication #1732)
The Declaration of Helsinki is the standard-bearer for international research ethics and enjoys particular respect in the developing world. It would be tragic if the U.S. tendency to arrogantly flout international mores claimed the declaration as another victim, even as the President touts the universalism of human rights.
[Created on 3/25/2005]

Petition to the FDA to Remove the Attention Deficit Drug Pemoline (Cylert) From the Market Because of Liver Toxicity (HRG Publication #1731)
In addition to having no demonstrated unique therapeutic benefit over other ADHD drugs such as methylphenidate (Ritalin), pemoline is known to have caused at least 21 cases of liver failure, including 13 resulting in liver transplantation or death.
[Created on 3/24/2005]

Statement of Sidney Wolfe, M.D. Regarding the FDA’s Decision to Leave Crestor on the Market (HRG Publication #1730)
Once again, when faced with concerns about the safety of a drug, the FDA has sided with the drug company, AstraZeneca, instead of the public. When Crestor is taken off the market, if not before, this will represent yet another blow to the agency’s badly tarnished reputation.
[Created on 3/14/2005]

Letter to FDA Shows That Crestor Has Higher Rates of Rhabdomyolysis Compared to Other Statins (HRG Publication #1729)
We found that the rate of reports of rhabdomyolysis sent to the FDA per million prescriptions filled for Crestor (13.1 reports per million prescriptions) is 6.2 times higher than the rate for all of the other statins combined (2.1 reports per million prescriptions filled).
[Created on 3/10/2005]

Petition to the FDA to Remove the Cancer Drug Gefitinib (Iressa) From the Market (HRG Publication #1728)
We, therefore, call on you to withdraw Iressa from the market. Any unapproved uses of Iressa can be explored using the experimental Investigational New Drug (IND) mechanism. The IND is the procedure used to study drugs before approval to ensure that their safety and efficacy meets certain standards before marketing.
[Created on 3/3/2005]

Painkillers and Terrorism. Letter to the Editor of The New York Times on Cox-2 Painkillers (HRG Publication #1727)

Given the lack of evidence that cox-2 drugs are more effective than older pain/arthritis drugs and that they cause significant risks of heart attacks and other cardiovascular disorders, why is the military jeopardizing the troops’ health by using these drugs, and why is the F.D.A. ready to leave Celebrex and Bextra on the market and even consider remarketing Vioxx?
[Created on 2/28/2005]

Letter Detailing Needed Improvements to FDA’s Essential MedWatch Adverse Events Reporting System (HRG Publication #1726)
FDA’s MedWatch program is necessary for the proper performance of FDA’s functions. Tardy [or incomplete] database posting subverts the intent of the FOI Act by preventing the public from obtaining current information so it can independently evaluate the links between drugs and adverse events. As recent events have shown, both FDA and the general public are in need of such independent evaluations.
[Created on 2/25/2005]

Review of “Science in the Public Interest: Has the Lure of Profits Corrupted Biomedical Research?” by Sheldon Krimsky. Review by Peter Lurie, M.D., M.P.H. (HRG Publication #1722)
Krimsky also proposes an independent national institute of drug testing, which would accept industry funding to test the companies’ products, but would leave study design, conduct, analysis and reporting securely in the hands of disinterested scientists. This is an idea whose time has long come, but, at least under the present circumstances, is unlikely to curry favor with the well-heeled lobbyists in Washington who represent the very corporations that increasingly fund biomedical science.
[Created on 2/18/2005]

Testimony to FDA on Dangers of Cox-2 Drugs (HRG Publication #1725)
Given that Celebrex and Bextra are making an important contribution to the estimated 100,000 deaths and 2.1 million serious injuries a year from adverse drug reactions, I hope you will recommend a ban of these two drugs. Label limitations to short-term use will fail just as they did with the now-banned NSAID, Duract.
[Created on 2/17/2005]

Small but Dangerous: a Letter to The Washington Post by Peter Lurie, M.D., M.P.H., and Nicholas Stine Regarding the Potential Toxicities of Nanotechnology (HRG Publication #1723)
The Royal Society and the Royal Academy of Engineering recently concluded that “factories and research laboratories [should] treat manufactured nanoparticles and nanotubes as if they were hazardous.” It is important that safety concerns go hand in hand with the justified enthusiasm for nanomedicine’s potential.
[Created on 2/14/2005]

Congressional Testimony by Sidney Wolfe M.D. on Current Issues Related to Medical Liability Reform (HRG Publication #1724)
Under the most perfect circumstances, if the FDA were actually doing as good a job as possible at preventing the approval of drugs and other medical products whose benefits are known to be outweighed by their risks and, as expeditiously as possible, removing such products when such risks are discovered after approval, this legislation would still unfairly punish patients and their families.
[Created on 2/10/2005]

Letter to FDA Revealing Heart Dangers in an Unpublished Clinical Trial of Celebrex (HRG Publication #1721)
Trial revealing statistically significant heart dangers for Celebrex discovered on the PhRMA website.
[Created on 1/31/2005]

Petition to Remove the Cox-2 Inhibitors Celecoxib (Celebrex) and Valdecoxib (Bextra) From the Market (HRG Publication #1720)
Public Citizen, a nationwide consumer organization with a membership of more than 150,000, hereby petitions the Food and Drug Administration (FDA) to immediately remove the COX-2 inhibitors celecoxib (Celebrex) and valdecoxib (Bextra) from the market because of their cardiovascular risks. In 2004, a total of more than 36 million prescriptions were filled in the U.S. for these drugs (23.9 million for Celebrex and 12.9 million for Bextra).
[Created on 1/24/2005]

The Serious Public Health Dangers of Prescription-to-OTC Switch of Lovastatin (HRG Publication #1719)
A substantial percentage of those who would choose to use the OTC version of this drug, if it were made available, have a risk for Coronary Heart Disease that is so low that there is no evidence they will benefit from the drug. Thus, they would be subjected to the various risks of adverse reactions without any possibility of benefit. Thus the risks clearly outweigh the benefits for this group.
[Created on 1/14/2005]

Letter Expressing Serious Concerns With U.S. Department of Agriculture Policy Pertaining to Beef and Cattle Imports and the Effectiveness of the Canadian Feed Ban (HRG Publication #1718)
Letter by Wenonah Hauter and Peter Lurie, M.D., M.P.H.
[Created on 1/6/2005]

Comments on OSHA’s Proposed Rule on Hexavalent Chromium (HRG Publication #1717)
Comments by Peter Lurie, M.D., M.P.H. and Sidney M. Wolfe, M.D.
[Created on 1/3/2005]

2004

Letter Urging HHS Secretary Thompson to Inform Seniors That Appropriate Footwear Decreases Risk of Injury or Death From Falls (HRG Publication #1716)
A study shows that wearing sneakers or other athletic footwear decreases the chance that seniors will fall and injure themselves. HHS should warn seniors by putting an insert into Social Security checks.
[Created on 12/28/2004]

Take Drugs off the Market – Editorial in USA Today, December 27th, 2004 (HRG Publication #1715)
Editorial by Sidney Wolfe, M.D.
[Created on 12/27/2004]

Response to FDA’s Announcement About Use of Celebrex and Bextra (HRG Publication #1714)
Statement by Sidney M. Wolfe, M.D.
[Created on 12/23/2004]

Testimony Before the FDA Reproductive Health Advisory Committee Concerning the Transdermal Testosterone Patch (HRG Publication #1713)
Testimony by Sidney M. Wolfe, M.D.
[Created on 12/2/2004]

Letter to FDA Urging Action on Misleading Crestor Advertising by AstraZeneca (HRG Publication #1712)
Letter by Sidney M. Wolfe, M.D.
[Created on 11/24/2004]

Military Medicine and Human Rights (HRG Publication #1711)
This article, published in The Lancet, details possible reasons why military medical personnel have been implicated in human rights violations and calls for better training for physicians in domestic and international human rights issues.
[Created on 11/19/2004]

Letter to FDA Renewing Call for Crestor to Be Removed From Market. Rate of Kidney Damage in Crestor Patients Is 75 Times Higher Than in Patients Taking Other Cholesterol Drugs (HRG Publication #1710)
Letter by Sidney M. Wolfe, M.D.
[Created on 10/29/2004]

America’s Neglected Veterans: 1.7 Million Who Served Have No Health Coverage Report of the Study Group on Veterans’ Health Insurance (HRG Publication #1709)
[Created on 10/19/2004]

Dangers of Rosuvastatin Identified Before and After FDA Approval (HRG Publication #1699)
The lipid-lowering drug rosuvastatin is currently in the midst of the most heavily financed launch of a prescription drug ever. Here I present premarketing and postmarketing evidence of the dangers of the drug, and call for its removal from the market. Detailed briefing documents including unpublished reviews of safety and efficacy data from clinical trials are now made public on the internet before all Food and Drug Administration (FDA) advisory committee meetings discussing the approval of a new drug.
[Created on 10/18/2004]

Vioxx, Other “Super Aspirins” Are Super Disasters – Other Cox-2 Alternatives Have Safety Problems Too (HRG Publication #1707)
Statement by Sidney M. Wolfe, M.D.
[Created on 9/30/2004]

Testimony Before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Hearing on Ximelagatran–September 10, 2004 (HRG Publication #1706)
Testimony by Peter Lurie, M.D., M.P.H. and Elizabeth Barbehenn, Ph.D.
[Created on 9/10/2004]

Letter to the FDA’s Office for Science and Health Coordination Urging Them Not to Abandon the Declaration of Helsinki in Ensuring Protection of Human Subjects in Certain Foreign Clinical Studies (HRG Publication #1705)
Letter by Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 9/1/2004]

Open Letter to Annette King, Minister of Health, New Zealand, Printed in the British Medical Journal (HRG Publication #1704)
[Created on 8/23/2004]

Letter to FDA Calling for Criminal Investigation of AstraZeneca Because the Company Illegally Delayed Submitting Reports of Serious Adverse Reactions to Cholesterol Drug Crestor (HRG Publication #1703)
Letter by Sidney M. Wolfe, M.D.
[Created on 8/3/2004]

Drug Ads Masquerading as News: Letter to 258 Local Television Station General Managers and News Directors in the Country’s Top-30 Television Markets (HRG Publication #1702)
This summer, health information publisher MediZine Inc. and syndicated news programmer Daily Health Feed (DHF) will begin offering a series of health-related features to TV stations in major U.S. markets. This will be in addition to the DHF health news feeds that already are carried by stations in 39 markets. According to MediaDailyNews, these segments will be bought and paid for by major pharmaceutical marketers and offered free of charge to local stations.
[Created on 7/29/2004]

Testimony by Peter Lurie, M.D. on Mad Cow Disease Surveillance Before a Joint Meeting of the United States House of Representatives Committee on Government Reform and Committee on Agriculture (HRG Publication #1701)
Testimony by Peter Lurie, M.D.
[Created on 7/14/2004]

Letter to NIH Director Questioning the Propriety of the Actions of a Senior NIH Scientist Who Was a Consultant for AstraZeneca (HRG Publication #1700)
Letter to NIH Director questioning the propriety of the actions of a senior NIH scientist who was a consultant for AstraZeneca, was the editor of the proceedings of a symposium and the author of an article in the proceedings containing an incomplete, inaccurate analysis understating the serious risks of AstraZeneca’s cholesterol-lowering drug, rosuvastatin (Crestor).
[Created on 7/8/2004]

Letter to the FDA Urging Removal of the Cholesterol-Lowering Drug Rosuvastatin (Crestor) From the Market (HRG Publication #1698)
As you are aware, on March 4th of this year, we petitioned the FDA to ban the recently-marketed cholesterol-lowering drug rosuvastatin (Crestor/AstraZeneca) because of seven post-marketing cases of life-threatening rhabdomyolysis and nine cases of renal failure or renal insufficiency.
[Created on 5/18/2004]

Testimony Before FDA Advisory Committee Concerning Alosetron (Lotronex) (HRG Publication #1697)
New Data Reconfirms Dangers of Controversial Drug Lotronex.
[Created on 5/5/2004]

Ranking of the Rate of State Medical Boards’ Serious Disciplinary Actions in 2003 (HRG Publication #1696)
Report by Sidney M. Wolfe, M.D. and Peter Lurie, M.D., M.P.H.
[Created on 4/14/2004]

Testimony Before the Taskforce on Drug Importation (HRG Publication #1695)
Testimony of Peter Lurie, M.D., M.P.H., Deputy Director, Public Citizen’s Health Research Group before the Taskforce on Drug Importation
[Created on 3/19/2004]

Petition to the FDA to Remove the Cholesterol-Lowering Drug Rosuvastatin (Crestor) From the Market (HRG Publication #1693)
We have obtained new information from the FDA and health agencies in Canada and the U.K. concerning serious post-marketing adverse reactions – including seven cases of life-threatening rhabdomyolysis (muscle destruction) and nine cases of kidney failure or kidney damage – in patients mostly using lower doses of this recently-approved cholesterol-lowering drug, rosuvastatin.
[Created on 3/4/2004]

Letter to World Medical Association Concerning Continuing Efforts to Amend Declaration of Helsinki (HRG Publication #1692)
The 2000 Declaration of Helsinki offered, for the first time, in language that was as clear as was possible, an enunciation of what ought to have been standard practice for decades. There is no justification for retreating from that important step forward. It is time to get past the delay-of-game tactics of Paragraph 30’s opponents and beginning to ensure that the fundamental ethical principles it enshrines are actually enforced.
[Created on 3/1/2004]

Testimony Before FDA Advisory Committee on Accutane (HRG Publication #1691)
The acne drug Accutane, which causes birth defects and life-threatening adverse events, should be removed from the market and prescribed only under very limited and controlled conditions.
[Created on 2/26/2004]

Letter to Agriculture Secretary Ann Veneman Concerning False or Misleading Government Reassurances on Mad Cow Disease (HRG Publication #1690)
Letter by Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 2/19/2004]

Medical Education Courses in Research-Based Health Activism (HRG Publication #1694)
January 2004 Virtual Mentor article by Oren M. Tepper, M.D., Peter Lurie, M.D., M.P.H. and Sidney M. Wolfe, M.D.
[Created on 1/31/2004]

Public Citizen Comments on Lifting Barriers to Beef Imports From Canada (HRG Publication #1686)
Comments by Peter Lurie, M.D., M.P.H., Wenonah Hauter and Sidney M. Wolfe, M.D.
[Created on 1/6/2004]

2003

Statement Regarding First U.S. Case of Mad Cow Disease (HRG Publication #1685)
Statement by Wenonah Hauter, Peter Lurie, M.D., M.P.H., Rodney Leonard, Felicia Nestor and Stan Painter
[Created on 12/24/2003]

A Federal Failure in Psychiatric Research: Continuing NIMH Negligence in Funding Sufficient Research on Serious Mental Illnesses (HRG Publication #1684)
Report by E. Fuller Torrey, M.D., Mary T. Zdanowicz, J.D., Sidney M. Wolfe, M.D., Peter Lurie, M.D., M.P.H., Irving I. Gottesman, Ph.D. and John M. Davis, M.D.
[Created on 11/19/2003]

Letter to FDA Concerning Potential Conflict of Interest Between Silicone Implant Advisory Panel Committee Member Dr. Michael Miller and His Institution M.D. Anderson and Inamed Aesthetics (HRG Publication #1683)
Letter by Sidney M. Wolfe, M.D.
[Created on 11/17/2003]

Petition to Halt FDA’s Decision on Allowing Silicone Gel Breast Implants Back on the Market (HRG Publication #1682)
Petition by Kim Gandy, Cynthia A. Pearson and Sidney M. Wolfe, M.D.
[Created on 11/3/2003]

Supplement to Petition to the FDA to Ban the Antidepressant Drug Nefazadone (Serzone) (HRG Publication #1681)
We have now updated that analysis to cover the subsequent time period, April 1, 2002 through May 12, 2003. During that period, FDA adverse event data recorded an additional 9 deaths, for a total of 20 reports of death due to liver failure in people using Serzone.
[Created on 10/29/2003]

Letter to American Hospital Association Concerning OSHA Citation of Montefiore Medical Center for Violating Needlestick Injury Prevention Regulations (HRG Publication #1680)
Letter by Steve Cha, M.D., Joseph Ross, M.D., Peter Lurie, M.D., M.P.H., Lauren Oshman, M.D., M.P.H. and Sidney M. Wolfe, M.D.
[Created on 10/28/2003]

Comments on the Mine Safety and Health Administration’s Proposed Rule on Occupational Exposure to Diesel Exhaust (HRG Publication #1679)
Comments by Peter Lurie, M.D., M.P.H. and Sidney M. Wolfe, M.D.
[Created on 10/14/2003]

Statement by Sidney Wolfe, M.D. at FDA Hearing on Silicone Gel Breast Implants (HRG Publication #1678)
Statement by Sidney Wolfe, M.D.
[Created on 10/14/2003]

Letter to FDA Concerning Potentially Dangerous Patient Information on Hormone Replacement Therapy (HRG Publication #1677)
Rather than promoting incomplete information, you should seek to ensure that women ask for and receive the FDA-approved patient information that is required by regulation to be distributed with each prescription for a non-contraceptive estrogen product.
[Created on 9/27/2003]

Petition Supplement to FDA Outlining the Rising Number of Cardiovascular Events Associated With the Diet Drug Sibutramine (Meridia) (HRG Publication #1675)
Since then [since the original petition], from reviewing subsequent FDA adverse event data, we have become aware of an additional 30 cardiovascular deaths in people using Meridia, for a total of 49 cardiovascular deaths. Twenty-seven of the 49 (68%) were in people less than 50 years old.
[Created on 9/3/2003]

Letter to the World Medical Association Opposing Proposed Changes to Paragraph 30 of the Declaration of Helsinki (HRG Publication #1674)
For if researchers can, with limited effort, escape the requirement to provide drugs to their own participants/patients at the conclusion of a trial, how can they be required to provide medications to those who have never been under their care?
[Created on 8/28/2003]

Administrative Waste in the U.S. Health Care System in 2003 (HRG Publication #1689)
“Administrative Waste in the U.S. Health Care System in 2003: The Cost to the Nation, the States and the District of Columbia, With State-Specific Estimates of Potential Savings” — a Report by David U. Himmelstein, M.D., Steffie Woolhandler, M.D., M.P.H. and Sidney M. Wolfe, M.D.
[Created on 8/20/2003]

Administrative Waste in the U.S. Health Care System in 2003 (HRG Publication #1673)
Statements and Report by David U. Himmelstein, M.D., Steffie Woolhander, M.D., M.P.H. and Sidney M. Wolfe, M.D.
[Created on 8/27/2003]

Comments by Sidney M. Wolfe, M.D and Larry D. Sasich, Pharm.D., M.P.H. Before FDA Hearing on Current Status of Useful Written Prescription Drug Information for Consumers, July 31, 2003 (HRG Publication #1672)
It is time to end the double standard wherein doctors and other health professionals use and are informed by FDA-approved labeling but patients, like second-class citizens, get whatever the out-of-control purveyors of patient information leaflets choose to have dispensed to them with their prescription drugs.
[Created on 7/31/2003]

Letter to HHS Urging a Federal Investigation of Medical Schools Conducting Unethical Research on Their Own Students (HRG Publication #1671)
Letter by Peter Lurie, M.D., M.P.H. et al.
[Created on 7/22/2003]

Letter to USDA Urging the Continuation of the Ban on the Import of Ruminants and Ruminant Products From Canada, July 17, 2003 (HRG Publication #1670)
Letter by Peter Lurie, M.D., M.P.H., Patricia Lovera and Sidney M. Wolfe, M.D.
[Created on 7/17/2003]

Statement of Sidney M. Wolfe, M.D. Before the FDA Endocrinologic and Metabolic Drugs Advisory Committee Hearing on Rosuvastatin (HRG Publication #1669)
In summary, we strongly oppose the approval of rosuvastatin because of its unique renal toxicity. We are also seriously concerned because of the seven cases of rhabdomyolysis that were common enough to have shown up in clinical trials, unlike the pre-approval studies with all previously approved statins, including cerivastatin.
[Created on 7/9/2003]

Statement of Peter Lurie, M.D., M.P.H. Before National Academy of Sciences’ Committee on Clinical Research Involving Children (HRG Publication #1668)
A strong statement by the Committee condemning the export of pediatric studies for the purposes of exploiting the lack of ethical oversight or the poverty of pediatric patients in developing countries would be most helpful.
[Created on 7/9/2003]

Testimony of Sidney Wolfe, M.D. Before Endocrinologic and Metabolic Drugs Advisory Committee Concerning the Use of Growth Hormone for Idiopathic Short Stature (HRG Publication 1667a)
Testimony of Sidney Wolfe, M.D.
[Created on 6/10/2003]

Petition to the FDA to Add a Black Box Warning to the Label of the Cancer Drug Iressa (HRG Publication #1667)
It is in regard to both the potential for misuse in groups in which it is not efficacious, as well as to provide a clear warning to patients that they may be at risk of a fatal lung disease unrelated to NSCLC, that we feel a black box warning in the Iressa label is necessary.
[Created on 5/15/2003]

Book Review by Sidney Wolfe Appearing in the New England Journal of Medicine (HRG Publication #1666)
Book Review by Sidney Wolfe, M.D.
[Created on 5/8/2003]

Letter to FDA Expressing Concerns About the Pending Approval of the Cancer Drug Gefitinib (Iressa) (HRG Publication #1665)
We understand that the gravity of NSCLC and the lack of effective therapy leave patients with few treatment options. But in this case, the data are either the product of poorly designed trials or, in the better-designed trials, unequivocally negative. Approval of any drug under these circumstances cannot be justified.
[Created on 5/1/2003]

Article by Sidney Wolfe in Science Magazine: Ephedra Scientific Evidence Versus Money/Politics (HRG Publication #1664)
Twenty-Year Chronology of Events Concerning Ephedrine Alkaloids, released in conjunction with publication of article in Science magazine: Ephedra Scientific Evidence Versus Money/Politics.
[Created on 4/17/2003]

Letter to NIH Director That Continues to Raise Ethical Concerns About the “Alzheimer’s Disease Anti-Inflammatory Prevention Trial” (ADAPT) (HRG Publication #1663)
To subject healthy people to long-term NSAID use with all the potential adverse effects, without arranging to test the one drug thought most likely to be of benefit, seems highly unethical. It seems clear from available experimental data that some non-steroidal anti-inflammatory drugs (NSAIDs) are more likely to succeed than others and may be both safer and cheaper. Such a drug, logically, would be the one to test; this is why we supported the use of ibuprofen.
[Created on 4/15/2003]

Consumer Product Safety Commission Announces Ban on Lead-Wick Candles (HRG Publication #1662)
Statement by Peter Lurie, M.D., M.P.H.
[Created on 4/8/2003]

Lawsuit Settled: Government Agrees to Follow Law, Take Steps Toward Useful Patient Drug Information Program (HRG Publication #1661)
[Created on 4/7/2003]

Press Release: Court Orders OSHA to Protect Workers From Hexavalent Chromium, a Dangerous Lung Carcinogen (HRG Publication #1660)
[Created on 4/3/2003]

Statement of Paul D. Stolley, M.D., M.P.H. That Comments on the FDA Risk-Management Concept Papers (HRG Publication #1656)
We are also concerned that the promise of postmarketing studies may be used to approve new drugs inappropriately or delay the removal or relabeling of dangerous drugs. In a survey of the FDA’s reviewing Medical Officers that the Health Research Group conducted in 1998, many officers felt pressure to approve drugs that they might not have approved; the companies’ promises of Phase 4 studies (many of which will presumably never be completed) tipped the balance for approval.
[Created on 4/3/2003]

Press Release: Court Orders OSHA to Protect Workers From Hexavalent Chromium, a Dangerous Lung Carcinogen (HRG Publication #1660)
[Created on 4/3/2003]

Ranking of State Medical Board Serious Disciplinary Actions in 2002 (HRG Publication #1658)
Every year, we evaluate how well each state medical board is protecting the public by disciplining doctors. This year, Minnesota disciplined the fewest doctors, and Louisiana disciplined the most doctors.
[Created on 3/27/2003]

Petition to the FDA to Ban the Antidepressant Drug Nefazadone (Serzone) (HRG Publication #1657)
Our own analysis, based on adverse reaction reports to the FDA, revealed that, from 1994, when first marketed, through the first quarter of 2002, nefazodone was associated with at least 53 cases of liver injury including 21 cases of liver failure from which 11 people died.
[Created on 3/6/2003]

A Free Ride for Bad Doctors (HRG Publication #1655)
Op-Ed by Sidney Wolfe, M.D.
[Created on 3/4/2003]

Comments Concerning OSHA’s Failure to Set Adequate Standards for Occupational Exposure to Beryllium (HRG Publication #1654)
Petition by Peter Lurie, M.D., M.P.H., Sidney M. Wolfe, M.D. and Robert Horsch, M.P.H.
[Created on 2/24/2003]

Letter to CPSC on Agency’s Failure to Take Final Action Banning Lead-Wick Candles (HRG Publication #1653)
Letter by Peter Lurie, M.D., M.P.H. and Alan Morrison
[Created on 2/3/2003]

Remedies Needed to Address the Pathology in Reporting Adverse Reactions and Food and Drug Administration Use of Reports (HRG Publication #1659)
The articles in this issue concerning adverse events and errors provide an overview of the anatomy and physiology of the process of soliciting and analyzing adverse drug reaction reports at the Food and Drug Administartion (FDA) and a useful taxonomy of the ways of measuring errors and adverse events more generally in health care. Both fall short, however, of addressing the most serious pathology and proposing adequate remedies.
[Created on 1/31/2003]

ACGME’S False Claims on Resident Work Hours (HRG Publication #1651)
Letter by Peter Lurie, M.D., M.P.H. and Sidney M. Wolfe, M.D.
[Created on 1/9/2003]

Statement on Medical Malpractice by Sidney M. Wolfe, M.D. (HRG Publication #1652)
Statement by Sidney M. Wolfe, M.D.
[Created on 1/9/2003]

2002

Letter to Senator Edward Kennedy Concerning Major Violations Uncovered at American Red Cross Headquarters Following FDA Inspection (HRG Publication #1650)
Letter by Sidney M. Wolfe, M.D.
[Created on 12/30/2002]

Comments on OSHA Request for Information on Occupational Exposure to Hexavalent Chromium (HRG Publication #1649)
Comments by Peter Lurie, M.D., M.P.H. and Sidney M. Wolfe, M.D.
[Created on 11/20/2002]

Continuing Exposure to Hexavalent Chromium, a Known Lung Carcinogen: an Analysis of OSHA Compliance Inspections, 1990-2000 (HRG Publication #1648)
Article by Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 10/31/2002]

Drug Safety Withdrawals: Who Is Responsible for Notifying Patients? (HRG Publication #1647)
Editorial by Sidney Wolfe, M.D.
[Created on 10/29/2002]

Risk-Related Behavior, Sexual Coercion, and Implications for Prevention Strategies Among Female Apprentice Tailors, Ibadan, Nigeria (HRG Publication #1646)
Article by Peter Lurie, M.D., M.P.H., appearing in AIDS and Behavior, September 2002.
[Created on 10/29/2002]

Comments to FDA on First Amendment Issues, Specifically Related to FDA Enforcement of Drug Advertising Laws and Regulations (HRG Publication #1645)
We begin with a brief discussion of the nature of advertising and FDA enforcement actions with regard to advertising. We then address promotion of products for unapproved uses, including promotion of products never approved for any use.
[Created on 10/28/2002]

Letter to FDA Addressing Dr. Gary Firestein’s Comments Concerning HRG’s Petition to Remove Arava From the Market (HRG Publication #1644)
It is discouraging that we have a so-called expert in the field of rheumatology who, apparently, has not thoroughly read either our petition or the original label for leflunomide, yet feels free to attack our petition. We tried in our petition to present as much information as was available, to analyze it rigorously, and to provide references so that our statements could be checked; unfortunately, Dr. Firestein failed to do this.
[Created on 10/15/2002]

Comments to the FDA on Proposed Rulemaking to Address Concerns of Needlestick Injuries From Syringes, IV Catheters and Blood Collection Devices (HRG Publication #1643)
Comments by Peter Lurie, M.D., M.P.H. and Sidney M. Wolfe, M.D.
[Created on 10/11/2002]

Testimony Before Senate Governmental Affairs Committee Hearing on Dangers of Ephedra (HRG Publication #1642)
This apparently inherent ability of ephedrine alkaloids to provoke chest pain and induce myocardial infarction in healthy patients is of particular concern because of the implications for vulnerable patients using other medications or with previously undiagnosed underlying medical conditions. Note that some of these adverse cardiovascular events can occur at the recommended dose.
[Created on 10/8/2002]

An Outbreak of Web Sites Selling Ciprofloxacin Following an Outbreak of Anthrax by Mail (HRG Publication #1641)
We identified 59 Web sites selling ciprofloxacin without prescription, 23 (39%) of which were established during the 2 weeks following October 4, 2001 (Figure 1). None of the sites was certified by the Verified Internet Pharmacy Practice Sites program.
[Created on 10/7/2002]

Article in the Journal of the American Medical Association (JAMA) Showing That Lower Quality HMOs Are Less Likely to Publicly Disclose Their Performance Scores (HRG Publication #1640)
[Created on 9/23/2002]

Statement on Safety Issues Related to Acetaminophen Before the Nonprescription Drugs Advisory Committee (HRG Publication #1639)
A quarter of a century later we are facing an epidemic of fatal acetaminophen-associated poisonings: a near doubling from 76 in 1995 to 141 in 1999, according to data collected by the American Association of Poison Control Centers through its Toxic Exposure Surveillance System (TESS).
[Created on 9/19/2002]

Response to FDA Request for Comments on First Amendment Issues (HRG Publication #1638)
The extent to which the pharmaceutical industry controls the flow of information about its products is chilling, including the opportunity to manipulate the peer reviewed medical literature. The notion that market forces or physician expertise can adequately protect the public from being prescribed drugs for uses for which they have not been shown to be safe and effective flies in the face of the facts.
[Created on 9/13/2002]

Letter to HHS Secretary Tommy Thompson That Raises Ethical Concerns About the “Alzheimer’s Disease Anti-Inflammatory Prevention Trial” (ADAPT) (HRG Publication #1637)
Because patients are taking drugs without true informed consent, Public Citizen urges the NIA to immediately stop this unethical trial and provide patients already enrolled in the trial with the information previously denied them on lack of plausible benefit as well as the possible health risks.
[Created on 9/4/2002]

Letter to the Accreditation Council for Graduate Medical Education (ACGME) Regarding its Draft “Principles to Guide the Relationship Between Graduate Medical Education and Industry” (HRG Publication #1636)
Cop out. There is no other way to describe the ACGME draft Principles to Guide the Relationship between Graduate Medical Education and Industry. The draft Principles are an at-times eloquent description of the massive conflicts that attend the growing relationship between industry and medical education programs. But when it comes time for the draft Principles to actually delineate what is and is not acceptable, the raison d’etre for these Principles, the draft document simply evades the issue.
[Created on 8/23/2002]

Letter to HHS Secretary Tommy Thompson Urging Him to Direct the FDA to Open a Criminal Investigation of Metabolife (HRG Publication #1635)
This letter strongly urges you to direct FDA Chief Counsel Dan Troy to agree that a criminal investigation of Metabolife be opened, as requested in a July 1, 2002, letter he was sent from Eugene M. Thirolf, Director, Office of Consumer Litigation, U.S. Department of Justice (DOJ). In that letter, the DOJ official states that Michael Ellis, the President of Metabolife, one of the nation’s largest producers of ephedrine-based dietary supplements, may have made false statements to the FDA.
[Created on 8/15/2002]

Letter to the Editor of The Washington Post on “Botox Night” at Johns Hopkins Hospital (HRG Publication #1634)
Patrick J. Byrne revises history in his Aug. 3 letter about the July 11 Botox Night at Johns Hopkins when he claims that the organization of the seminar was never altered.
[Created on 8/14/2002]

Letter to Accreditation Council for Graduate Medical Education on Medical Resident Duty Hours (HRG Publication #1633)
Letter by Peter Lurie, M.D., M.P.H. and Sidney M. Wolfe, M.D.
[Created on 8/1/2002]

Letter to the Editor of the Wall Street Journal on Former President Clinton’s Acknowledgement That He Was Wrong for Not Heeding Scientific Evidence on the Efficacy of Needle Exchange Programs (HRG Publication #1632)
Letter to the Editor of the Wall Street Journal on former President Clinton’s acknowledgement that he was wrong for not heeding scientific evidence on the efficacy of needle exchange programs.
[Created on 7/31/2002]

Letter to the Editor of the British Medical Journal on Previous Article on Disease Mongering (HRG Publication #1631)
Like the groups described by Moynihan et al, the 3M/ National Vaginitis Association is ostensibly an educational resource run by health professionals.Unfortunately, its activities include a large element of disease mongering. Mild symptoms are offered as portents of serious disease, and doctors are encouraged to be aggressive in their attempts to diagnose and treat vaginal infections, specifically bacterial vaginosis.
[Created on 7/29/2002]

Letter to Consumer Product Safety Commission Expressing Concern Over Delays in the Issuance of Proposed Rulemaking for Lead-Wick Candles (HRG Publication #1630)
Letter by Peter Lurie, M.D., M.P.H., Sidney M. Wolfe, M.D., David Vladeck, J.D., Don Ryan, M.U.R.P. and Eileen Lee, Ph.D.
[Created on 7/25/2002]

Comments Before FDA Drug Safety Advisory Committee on Patient Drug Information (HRG Publication #1629)
The failure of the private sector to meet the quality goals established in The Action Plan and thus the failure to achieve the distribution goal of 75 percent of patients getting scientifically accurate information leaves only one option under Public Law 104-180: the Secretary [Department of Health and Human Services] shall seek public comment on other initiatives that may be carried out to meet such goals.
[Created on 7/17/2002]

Letter to the President of the Association of American Medical Colleges Urging a National Policy Precluding the Demonstration or Administration of Medical Interventions Such as Botox (HRG Publication #1628)
To our knowledge, Johns Hopkins is the first medical school to have planned such an event. Given the increasing commercialization of medicine, including the proliferation of Botox parties, and its corrosive impact upon the credibility of the profession and the nation s medical schools, the time seems ripe to develop a national policy for medical schools that would preclude the demonstration or administration of medical interventions such as Botox.
[Created on 7/12/2002]

Letter to Dean of the Medical Faculty at Johns Hopkins School of Medicine Urging the Cancellation of “Botox Night” (HRG Publication #1627)
If you wish to ensure that the Johns Hopkins School of Medicine maintains its reputation as one of the world’s leading medical schools, you will immediately cancel the Botox Night, similar in many respects to a so-called Botox Party, scheduled for Johns Hopkins’ Outpatient Center this Thursday, July 11. This event is unseemly, unprofessional and undermines the core educational mission of the university.
[Created on 7/9/2002]

Letter to Senator Edward Kennedy Urging Him to Vote Against Dr. Richard Carmona as Surgeon General (HRG Publication #1626)
Letter by Sidney Wolfe, M.D.
[Created on 7/8/2002]

Comments on the U.S. Department of Labor Draft Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information Disseminated by the Department of Labor (HRG Publication #1625)
Comments by Frank Clemente and Sidney Wolfe, M.D.
[Created on 7/1/2002]

Statement on HHS Failure to Ban Ephedra or Issue Adequate Warnings (HRG Publication #1624)
Today’s announcement by the Department of Health and Human Services (HHS), which not only fails to ban ephedra dietary supplements but also fails to seriously warn against the use of these products, should result in the firing of all officials in HHS and the Food and Drug Administration (FDA) who are responsible for this dangerous cowardice.
[Created on 6/14/2002]

Comments on Food and Drug Administration (FDA) Implementation of the Data Quality Act (HRG Publication #1623)
In fact, the initiative seems less motivated by an affinity to improved scientific standards than it is by industry’s desire to reduce the amount of potentially lifesaving information disseminated, needlessly delay information that actually makes it through the gauntlet represented by these standards and potentially provide industry with a mechanism to force agencies to withdraw documents previously issued by the FDA that the industry finds troublesome.
[Created on 6/13/2002]

Allowing Lotronex Back on the Market Will Endanger Patients (HRG Publication #1622)
Reintroducing Lotronex onto the market as announced today by the U.S. Food and Drug Administration (FDA) will endanger patients, Public Citizen said today. Not only is the new marketing program too lax to prevent harm, but it is to be overseen by the company that makes the drug – a poor idea because the company has a financial incentive to downplay problems with the drug. Also, the recommended dose has not been shown to be effective.
[Created on 6/7/2002]

Statement at FDA Hearing on Risk Management of Prescription Drugs (HRG Publication #1620)
The single most important risk management strategy the FDA can undertake in the short-term to reduce the publics risk from preventable adverse drug reactions is to go forward as rapidly as possible with regulations that require pharmacists to distribute scientifically accurate, useful written drug information, or Medication Guides, approved by the agency. At the very least, this would provide consumers with a reliable source of information that they can use to protect themselves from preventable injury.
[Created on 5/22/2002]

Letter to HHS Urging That Criminal Charges Be Brought Against Abbott Laboratories for Illegally Withholding Information Concerning Eight Deaths and Other Adverse Effects of the Drug Sibutramine (Meridia) (HRG Publication #1619)
The purpose of this letter is to strongly urge you to bring criminal charges against Abbott Laboratories for illegally withholding from the FDA important information concerning eight deaths and other adverse effects of their big-selling obesity drug, sibutramine (Meridia), a drug we asked you to ban in March of this year.
[Created on 5/21/2002]

Article in JAMA: Timing of New Black Box Warnings and Withdrawals for Prescription Medications (HRG Publication #1618)

Patient exposure to new drugs with unknown toxic effects may be extensive. Nearly 20 million patients in the United States took at least 1 of the 5 drugs withdrawn from the market between September 1997 and September 1998. Three of these 5 drugs were new, having been on the market for less than 2 years. Seven drugs approved since 1993 and subsequently withdrawn from the market have been reported as possibly contributing to 1002 deaths.
[Created on 5/1/2002]

Testimony Before FDA Advisory Committee Concerning Alosetron (Lotronex) (HRG Publication #1617)
From our analysis of adverse event data from the FDA and the FDA briefing documents, as of 12/31/01 there have been 352 hospitalizations associated with the use of alosetron, the majority associated with gastrointestinal adverse reactions, 85 cases of ischemic colitis and 13 deaths, seven of which show a strong association with alosetron according to the FDA.
[Created on 4/23/2002]

Ranking of State Medical Boards’ Serious Disciplinary Actions in 2001 (HRG Publication #1616)
Report by Sidney M. Wolfe, M.D.
[Created on 4/9/2002]

Survey of Doctor Disciplinary Information on State Web Sites (HRG Publication #1615)
Report by John Paul Fawcett, Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 4/9/2002]

Petition to Ban Arthritis Drug Leflunomide (Arava) (HRG Publication #1614)

Petition by Elizabeth Barbehenn, Ph.D., Peter Lurie, M.D., M.P.H. and Sidney M. Wolfe, M.D.
[Created on 3/28/2002]

Petition to FDA to Ban the Diet Drug Sibutramine (Meridia) (HRG Publication #1613)
According to the FDA database, since its launch in early 1998, sibutramine has now been associated with 29 deaths including 19 from cardiovascular adverse effects in people using this minimally effective drug.
[Created on 3/19/2002]

Comments on Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees; Draft Guidance (HRG Publication #1612)
An independent assessment of the nature and extent of a potential conflict of interest by the public involves not only the amount of fees paid by a sponsor, or the sponsor’s competitor, to an advisory committee member but the length of time that the financial arrangement has existed. Disclosure of only one year of information is not sufficient to place a potential conflict in perspective. There should be at least two years of information disclosed to the public.
[Created on 3/5/2002]

Public Citizen, PACE Sue to Protect Workers From Hexavalent Chromium (HRG Publication #1611)
[Created on 3/4/2002]

Direct-To-Consumer Advertising—Education or Emotion Promotion? (HRG Publication #1610)
Article by Sidney Wolfe, M.D. appearing in the New England Journal of Medicine on direct-to-consumer advertising of prescription drugs. Although increased access by patients to accurate, objective information about tests to diagnose and drugs to treat illnesses is an important advance, confusion arises when commercially driven promotional information is represented as educational.
[Created on 2/14/2002]

Accreditation Council for Graduate Medical Education Proposed Limits on Resident Physician Work Hours Are Inadequate (HRG Publication #1609)
[Created on 2/11/2002]

Letter to HHS Secretary Tommy Thompson Calling on the Government to Seize 10 Products Containing Synthetic Ephedra (HRG Publication #1608)
We now have evidence that you are not only failing to protect Americans by banning a chemical that has more reports of deaths, heart attacks, strokes, cardiac arrhythmias, hypertension and seizure than all other food supplements combined, but that you have failed to seize at least 10 products made by at least nine dietary supplement manufacturers who are selling products that illegally contain synthetic ephedrine alkaloids under the guise of being legitimate dietary supplements.
[Created on 1/31/2002]

Comments on: The Prescription Drug User Fee Act (PDUFA) (HRG Publication #1606)
Public Citizen’s position was then, and remains, that Congress must adequately fund the FDA using public money. Also, PDUFA’s second re-authorization in 1997, with its slavish deadlines and the accompanying ill-advised Food and Drug Administration Modernization Act (FDAMA) are examples of failed experiments in public policy.
[Created on 1/25/2002]

Letter to Senators Thomas Daschle, and Ted Kennedy Urging a Congressional Inquiry Into the Safety of the U.S. Blood Supply, Especially That Processed by the American Red Cross (HRG Publication #1605)
Letter by Sidney M. Wolfe, M.D. and Amer K. Ardati
[Created on 1/24/2002]

Letter to American Medical Association Urging Their Support of HRG Petition to the FDA to Ban Dietary Supplements Containing Ephedrine Alkaloids (HRG Publication #1604)
Letter from Amer Ardati and Sidney Wolfe, M.D.
[Created on 1/17/2002]

The Destruction of Medicine by Market Forces: Teaching Acquiescence or Resistance and Change? (HRG Publication #1603)
Medical schools have too often taught—actively, or passively by example—acquiescence to the increasing trends toward medicine as a business rather than teaching resistance to those trends in a manner consistent with medicine as a profession.
[Created on 1/9/2002]

2001

New Study Shows Low-Income, Minority Seniors Restrict Use of Prescription Drugs (HRG Publication #1602)
A study of a large, nationally representative sample of older Americans, to be published Dec. 4 in the Journal of General Internal Medicine, has found that 43 percent of those people without prescription drug coverage who are of minority ethnicity, have annual incomes of less than $10,000 and have out-of-pocket prescription drug costs of more than $100 per month reported restricting their use of prescribed medicines.
[Created on 12/4/2001]

The AMA Does It Again.” Statement Criticizing the American Medical Association’s Selection of Dr. Michael Maves for Executive Vice President. (HRG Publication #1601)
Letter by Sidney Wolfe, M.D.
[Created on 11/19/2001]

Letter to HHS Secretary on Pharmaceutical Research & Manufacturers of America Emergency Preparedness Task Force (HRG Publication #1600)
The PhRMA Task Force established at your behest is unquestionably a federal advisory committee subject to the Federal Advisory Committee Act (FACA). Accordingly, the HHS meetings with the Task Force violate FACA. Before a federal agency may use an advisory committee, FACA requires that the agency file a charter with the agency and with appropriate committees of Congress and provide a copy to the Library of Congress.
[Created on 11/8/2001]

Letter to the President of the New Mexico State Board of Medical Examiners on Dr. Fred Pintz’ Involvement and Assistance in Procuring Drugs for the Execution of Terry Clark (HRG Publication #1599)
Letter by Sidney M. Wolfe, M.D.
[Created on 11/2/2001]

Letter to the Editor of The New York Times Concerning Misstatements by HHS Secretary Tommy Thompson on Drugs Used to Treat Anthrax (HRG Publication #1598)
You quote Tommy G. Thompson, the secretary of Health and Human Services, as saying doxycycline and penicillin are just as effective as Cipro (news article, Oct. 20). The major study in the field, published by United States Army researchers in 1993, does not support this statement.
[Created on 10/24/2001]

Drugs for Possible Exposure to Anthrax: What Makes Sense? (HRG Publication #1597)
Unlike ciprofloxacin, which is still on patent to Bayer and which costs over $500.00 for a recommended 60 day course of treatment, doxycycline is available in a generic form and costs less than one-tenth as much, approximately $50.00, for 60 days of treatment.
[Created on 10/18/2001]

Letter Urging the FDA to Reject Drug Industry’s Request for Liability Disclaimer in its Withdrawal of Products Containing Phenylpropanolamine (PPA) (HRG Publication #1596)
The requested disclaimer would state that the withdrawal of PPA-containing drugs does not mean that the drugs were marketed negligently; this disclaimer is intended to gain some sort of protection for the companies from product liability suits.
[Created on 10/12/2001]

Statement Before the National Academy of Sciences on the Framework for Evaluating the Safety of Dietary Supplements (HRG Publication #1594)
Since at the heart of this problem is the irrational legal distinction that has been made between those pharmacologically active chemicals which are regulated as prescription or over-the-counter drugs and those which others call dietary supplements which I call drug supplements, eventually the same standards for safety and effectiveness must be adopted.
[Created on 10/11/2001]

Comments on the Draft Health and Human Services Inspector General’s Report: The Globalization of Clinical Trials (OEI-01-00-00190) (HRG Publication #1591)
While this report highlights the important issue of the increasing internationalization of medical research, it is lacking in three regards: 1. The report fails to draw adequately upon prior research in this area; 2. It fails to adequately emphasize the deficiencies of the data collected by the U.S. Food and Drug Administration (FDA); 3. The recommendations are too weak, even falling below those of the National Bioethics Advisory Commission (NBAC).
[Created on 10/2/2001]

Petition to the Food and Drug Administration (FDA) Requesting the Ban of Production and Sale of Dietary Supplements Containing Ephedrine Alkaloids. (HRG Publication #1590)
The Public Citizen Health Research Group, petitions the Food and Drug Administration (FDA) to ban the production and sale of dietary supplements containing ephedrine alkaloids. These dietary supplements include, but are not limited to, those containing ephedra, ephedra extract, and ma-huang. The grounds for FDA action are that these products present a significant or unreasonable risk of illness or injury under conditions of use suggested or recommended in the labeling
[Created on 9/5/2001]

Petition to OSHA to Lower Exposure to Beryllium, a Metal Directly Linked to a Fatal Lung Disease (HRG Publication #1589)
Comments by Howard Sobel, M.D., M.P.H., M.S., Peter Lurie, M.D., M.P.H., Dave Ortlieb and Sidney Wolfe, M.D.
[Created on 9/1/2001]

Letter in Internal Medicine News on Resident Work Hours
Letter to the Editor concerning incorrect graphic and explanation from original article on petition to OSHA concerning medical residents work hours.
[Created on 9/1/2001]

Petition to the FDA to Issue Strong Warnings About the Potential for Certain Cholesterol-Lowering Drugs to Cause Potentially Life-Threatening Muscle Damage. (HRG Publication #1588)
On the basis of these data, Public Citizen, representing 135,000 consumers nationwide, hereby petitions the FDA to add a black box warning and additional consistent bolded warnings about this serious problem to the label of all statins marketed in the United States.
[Created on 8/20/2001]

Petition to the FDA Asking Them to Ban the Use of Cadaveric Dura Mater Because It Risks Exposing Neurosurgery Patients to Creutzfeldt-Jakob Disease. (HRG Publication #1587)
[Created on 8/15/2001]

Letter to HHS That Supports a Criminal Investigation of Schering-Plough Based on the Possibility That the Company Knowingly Shipped Millions of Asthma Drug Inhalers That May Not Have Contained Any Active Ingredients. (HRG Publication #1586)
As can be seen on the chart below, there were no deaths reported to the FDA to have occurred in users of Proventil or Warrick’s albuterol (generic version also manufactured by Schering-Plough) during the first three quarters of 1998. However, starting with a death that occurred in the fourth quarter of 1998 and continuing through the second quarter of 2000, there were a total of 17 deaths for which the Schering-Plough albuterol was listed as the primary suspect and in which there is a date of death.
[Created on 8/9/2001]

Statement to the Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee Urging Them to Not Approve the Drug Teriparatide. (HRG Publication #1585)
Based on our review of the Food and Drug Administration’s (FDA’s) assessment of the clinical data as well as several published articles on teriparatide efficacy, we do not believe that a sufficient basis for approving the drug in either men or women exists at the present time.
[Created on 7/27/2001]

Testimony Before the Food and Drug Administration Endocrine and Metabolic Drugs Advisory Committee Meeting on Pramlintide (Symlin), Recommending That It Not Be Approved and That No Additional Clinical Trials Be Done (HRG Publication #1584)
We opposed the approval of Symlin because of increased severe hypoglycemia with automobile driving-related adverse events including crashes and confusion while driving (statistically significant); most people required paramedic intervention, ER visits and IV glucose administration; there was one death in an auto crash in a patient getting pramlintide.
[Created on 7/26/2001]

Testimony Before the Subcommittee on Consumer Affairs Hearing, Senate Commerce Committee on Direct-to-Consumer (DTC) Advertising. (HRG Publication #1583)
Because of the strong First Amendment in the U.S constitution, there is no way that DTC prescription drug advertising could ever be banned in this country. Having said that, however, there is an urgent need for more fine-tuned, better-staffed and much tougher government regulation of its content.
[Created on 7/24/2001]

Letter to the FDA Concerning Tegaserod (Zelnorm), for Constipation-Predominant Irritable Bowel Syndrome, and Novartis’ Reluctance to Use Ultrasound Monitoring for Their Clinical Trial Subjects. (HRG Publication #1582)
Tegaserod was associated with nine cases of ovarian cysts in women in clinical trials, eight of whom were taking tegaserod, all on the highest dose of this drug. All eight developed symptoms and five underwent hospitalization and surgery (one placebo patient had polycystic ovarian disease that did not require surgery.
[Created on 7/23/2001]

Report Submitted to the Department of Agriculture Which Discusses the Lack of Systematic Sampling of Cow Brains for Mad Cow Disease in the U.S. (HRG Publication #1581)
Report by Peter Lurie, M.D., M.P.H., Felicia Nestor, Patricia Lovera, Sidney Wolfe, M.D. and Wenonah Hauter.
[Created on 7/19/2001]

Letter to the Council for International Organizations of Medical Sciences (CIOMS) on Their Draft Ethical Guidelines Involving Human Subjects. (HRG Publication #1580)
The current draft revision of the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects should be called what it is: a bald-faced and dangerous attempt to reverse the gains in the protection of research participants accomplished in the October 2000 version of the World Medical Association’s (WMA’s) Declaration of Helsinki (DOH).
[Created on 7/13/2001]

Questionable Hospitals 2001: Patient Dumping by Hospital Emergency Rooms (HRG Publication #1579)
This report is the sixth in a series tracking the Department of Health and Human Services’ enforcement of the Emergency Medical Treatment and Labor Act, which prohibits “patient dumping” — a practice in which hospitals deny medical screening and/or treatment to emergency patients or women in labor, often by transferring them, in unstable conditions, to another hospital. Report by Kaija Blalock, R.N., J.D. and Sidney Wolfe, M.D.
[Created on 7/1/2001]

Comments to the Food and Drug Administration on the Proposed Rule to Revise the Format of Prescription Drug Professional Product Labeling (HRG Publication #1578)
We strongly support the creation of this section of the professional label. We do, however, recommend some minor modifications in the order in which information is presented. We believe that risk information (other bolded warnings [which are not now necessarily in the Highlights], contraindications and drug interactions) should appear higher up in the label, certainly before Dosage and Administration and How Supplied.
[Created on 6/22/2001]

Letter to the Food and Drug Administration on a Study Stating a Possible Mechanism for the Induction of Ovarian Cysts With the Use of Tegaserod (Zelmac) (HRG Publication #1577)
This is the first study to document the presence of the 5-HT4 receptor in ovarian tissue. As a result, we now have a plausible biological mechanism for the development of the observed ovarian cysts that occurred in women and rats.
[Created on 6/7/2001]

Letter to the Department of Justice Concerning the Drug Enforcement Agency’s Failure to Provide Complete Information to the National Practitioner Databank. (HRG Publication #1576)
Letter by Sidney Wolfe, M.D.
[Created on 6/6/2001]

Testimony Before the Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee on a Petition to Relabel Doxazosin (Cardura). (HRG Publication #1575)
As physicians being asked by patients to recommend drugs for the treatment of hypertension, it would be highly unlikely for you or for me, knowing what we now know, to recommend an alpha blocker such as Cardura as a first choice drug. More likely, we would relegate it to a fourth or lower choice drug, only after adequate trials of diuretics, beta blockers, or ACE inhibitors, alone and in combination, had been tried without success.
[Created on 5/24/2001]

Letter to Senators Charles Grassley and Max Baucus Referring to a Paper Presented at the Society of General Medicine Annual Meeting Which Discussed High Drug Costs and Lack of Drug Coverage. (HRG Publication #1574)
After adjusting for multiple factors, minorities with no prescription coverage were almost ten times as likely as minorities with full coverage to restrict their medication usage due to cost. Similarly, among patients with incomes under $10,000 per year, those without prescription coverage were 14 times as likely to restrict their medication use as those with full coverage.
[Created on 5/4/2001]

Letter in the Journal of the American Medical Association (JAMA) on Problems With the Immune Response Corporation’s HIV-1 Vaccine Study. (HRG Publication #1573)
We would like to point out that the IRC, which sponsored the study by Dr. Kahn and colleagues, has been accused of previous attempts to improperly influence the presentation of scientific data on its HIV-1 Immunogen.
[Created on 5/2/2001]

Letter to the FDA Concerning the Unresponsiveness of the Agency’s Freedom of Information Office to Our Requests (HRG Publication #1572)
Our success in obtaining this material has been steadily declining: the FOI office has become increasingly unresponsive to our requests and the CDER New and Generic Drug Approvals web site has been months to years behind in posting reviews.
[Created on 5/1/2001]

Petition to the Occupational Safety and Health Administration Requesting That Limits Be Placed on Hours Worked by Medical Residents (HRG Publication #1570)
Petition by Anandev Gurjala, Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 4/30/2001]

Press Release Commenting on a National Bioethics Advisory Commission Report on International Research Which Endorses Standards Lower Than Those of the October 2000 Declaration of Helsinki. (HRG Publication #1571)
The National Bioethics Advisory Commission (NBAC) today released a report that would put the U.S. in the unenviable position of endorsing ethics standards for American researchers that are lower than those required by the World Medical Association’s Declaration of Helsinki.
[Created on 4/30/2001]

Letters to the Association of American Medical Colleges and the Accreditation Council for Graduate Medical Education on Drug Industry Influence on Medical Residents Based on an Article in the American Journal of Medicine (HRG Publication #1569)
We are writing to the Accreditation Council for Graduate Medical Education (ACGME) because your organization accredits residency training programs to ask that you require much more education of residents concerning these issues and that you also urge widespread adoption of a model set of restrictions—based on the more stringent of those now in effect—to limit, if not eliminate, pharmaceutical industry contact with residents.
[Created on 4/26/2001]

Comments on the Food and Drug Adminstration’s Proposed Rule Concerning the Disclosure of Safety and Effectiveness Information About Unapproved, Investigational Products–Human Gene Therapy (HRG Publication #1567)
Unfortunately, the FDA has chosen to limit its proposal for disclosure to only two interventions: 1.) gene therapy; and 2.) the transplantation of non-human tissue to human beings (xenotransplantation). Regrettably, this proposed rule as it applies to gene therapy follows the practice of the National Institutes of Health’s (NIH) Recombinant DNA Advisory Committee (RAC) established 20 years ago. The FDA proposed rule is a long overdue attempt to harmonize its policy with that of the NIH.
[Created on 4/18/2001]

Letter to the FDA Concerning a Memo From Their Office of Post-Marketing Drug Risk Assessment (OPDRA) That Confirms and Extends the Dangers of the Drug Lotronex (Alosetron) for Irritable Bowel Syndrome (HRG Publication #1566)
The updated AERS data we obtained, which extend through the end of calendar year 2000, now include a total of 63 people with ischemic colitis and 75 people with severe constipation.
[Created on 4/18/2001]

HRG Report Ranking of State Medical Boards’ Serious Disciplinary Actions in 2000. (HRG Publication #1565)
Report by Sidney Wolfe, M.D.
[Created on 4/6/2001]

Press Release Commenting on Discovery Laboratories Inc. Redesigning its Study of Surfactant (Surfaxin) in Latin America. (HRG Publication #1564)
Following a campaign by Public Citizen, Discovery Laboratories Inc. of Doylestown, Penn., has redesigned its study of Surfaxin, its brand of the drug surfactant, which is used to treat Respiratory Distress Syndrome (RDS) in premature infants. Under the new design, no infants will receive a placebo.
[Created on 4/4/2001]

Testimony Before the Consumer Affairs, Foreign Commerce and Tourism Subcommittee Concerning Bovine Spongiform Encephalopathy (BSE), Otherwise Known as “Mad Cow Disease” (HRG Publication #1563)
Testimony by Peter Lurie, M.D., M.P.H.
[Created on 4/4/2001]

Comments on the Food and Drug Administration’s Decision to Amend Regulations Regarding Public Disclosure of Information Distributed to Advisory Committee Members for Their Review and Consideration (HRG Publication #1562)
Public Citizen strenuously opposes this proposal by the Food and Drug Administration (FDA) to amend its regulations regarding the public disclosure of written information distributed to FDA advisory committee members for their review and consideration prior to an advisory committee meeting. The FDA’s proposal would unnecessarily delay public access to important summary safety and efficacy information that is not exempt from disclosure about new drugs.
[Created on 3/26/2001]

Letter to the Food and Drug Administration Urging That It Not Approve Tegaserod (Zelmac) Because of its Highly Questionable Efficacy and its Potential to Cause Ovarian Cysts (HRG Publication #1561)
Public Citizen, a nationwide consumer organization with about 145,000 members, hereby strongly urges the Food and Drug Administration (FDA) not to approve the drug tegaserod (Zelmac, Novartis Pharmaceuticals), a drug for the treatment of constipation-predominant Irritable Bowel Syndrome (IBS) because of its highly questionable efficacy and because of serious safety concerns.
[Created on 3/22/2001]

Testimony Before the House of Representatives Committee on Government Reform Hearing on Dietary Supplements. (HRG Publication #1560)
When the first member of this committee or of Congress or their families, has a stroke, a fatal cardiac arrhythmia, or some other life-threatening adverse reaction to dietary supplements, perhaps there will be a belated reconsideration of the damage done by DSHEA. The law will then either be significantly modified or repealed so that pre-marketing safety and efficacy testing become the preferable alternative to post-marketing human experimentation.
[Created on 3/20/2001]

Request to HHS to Investigate Charges Against Schering-Plough for Possibly Knowingly Shipping Millions of Asthma Drug Inhalers That May Not Have Contained Any Active Ingredient (HRG Publication #1559)
We urge you to launch an investigation into criminal charges against Schering-Plough based on the possibility that the company knowingly shipped millions of the 59 million units of albuterol-containing asthma drug eventually recalled between the time the company became aware of the seriously flawed manufacturing processes and the time the recall was finally accomplished.
[Created on 3/1/2001]

Letter Requesting that HHS Halt Plans for Unethical Placebo-Controlled Study of Drug for Respiratory Distress Syndrome (HRG Publication #1558)
We have learned that the Food and Drug Administration (FDA) is seriously considering endorsing the design of a drug-company study of a new surfactant drug in four Latin American countries in which a control group of 325 premature newborn infants with potentially fatal Respiratory Distress Syndrome (RDS) would be treated with placebos instead of a lifesaving and already FDA-approved surfactant drug.
[Created on 2/22/2001]

Comments on the National Bioethics Advisory Commission Report on Ethical and Policy Issues in Research Involving Human Participants. (HRG Publication #1557)
The report is a significant review of the system and provides many thoughtful recommendations on improvements. The report describes the challenges facing the current system as significant and states that they call for major change (Chapter 1, p. 40, lines 3-4). We agree with this assessment, but feel that the changes recommended often fall short of major change, particularly in the area of conflict of interest.
[Created on 2/17/2001]

Press Release Reaction to Consumer Product Safety Commission Decision to Grant HRG Petition Banning Lead-Wicked Candles. (HRG Publication #1556)
Press Release by Peter Lurie, M.D., M.P.H.
[Created on 2/14/2001]

Comments on Action Requested by Consumer Product Safety Commission on Petition to Ban Lead-Wick Candles. (HRG Publication #1554)
Comments by Peter Lurie, M.D., M.P.H., Sidney Wolfe, M.D. and Howard L. Sobel, M.D., M.P.H., M.S.
[Created on 1/25/2001]

Letter to the Massachusetts Medical Society Describing a Get Rich Quick Scheme (Cash Cow) Sent to a New England Journal of Medicine List Serve. (HRG Publication #1553)
The week before last, those of us on a New England Journal of Medicine email list serve, which normally provides weekly announcements about the contents of the forthcoming issue of the Journal, received a surprising message entitled CASHCOW. The message described a get-rich-quick publishing scheme, promising that any participant could earn $50,000 in the next 90 days by sending e-mail. (see attached first page of this e-mail)
[Created on 1/24/2001]

Testimony Before the FDA Arthritis Drugs Advisory Committee on the Nonsteroidal Anti-Inflammatory Drugs Celecoxib and Rofecoxib (HRG Publication #1555)
A second box warning about cardiovascular toxicity needs to be added. It should warn of the lack of platelet aggregation inhibition of the drugs which protects those at risk from an increased occurrence of heart attacks. In addition, the evidence which is rapidly accumulating about the heart damage caused by these drugs must be mentioned in this cardiovascular box warning.
[Created on 1/7/2001]

Article in The Washington Post on Health Insurance Policies Requiring Personal Information Entitled “None of Our Business, and None of Theirs, Either.” (HRG Publication #1552)
Article by Alan Morrison and Sidney Wolfe, M.D.
[Created on 1/7/2001]

2000

Letter in The Lancet on Alosetron for Irritable Bowel Syndrome Showing Data Manipulation in a Company-Sponsored Clinical Trial. (HRG Publication #1551)
Letter by Elizabeth Barbehenn, Ph.D., Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 12/9/2000]

Letter to the National Bioethics Advisory Commission Criticizing Their Draft Report on Ethics of Research in Developing Countries. (HRG Publication #1550)
We are dismayed and deeply disappointed that the National Bioethics Advisory Commission (NBAC) has seen fit to radically alter its draft report on the ethics of research in developing countries at the last minute to no longer require review by a U.S. Institutional Review Board (IRB) of U.S. government-funded research in developing countries.
[Created on 12/6/2000]

Letter to the Food and Drug Adminstration Regarding Dangerous Practices by the American Red Cross and Safety of U.S. Blood Supply. (HRG Publication #1549)
Letter by Sidney Wolfe, M.D.
[Created on 12/1/2000]

Petition to the FDA by Health Research Group and Service Employees International Union Requesting the Removal of Unsafe Intravenous Injection Equipment From the Market. (HRG Publication #1548)
Petition by Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 11/29/2000]

Letter to the National Institute for Clinical Excellence Urging It to Reconsider Recommendations Concerning Relenza Use Among People in the United Kingdom. (HRG Publication #1547)
We are extremely concerned that the recent recommendations concerning the influenza drug zanamivir (Relenza) by the National Institute for Clinical Excellence (NICE), of which you are the Chair, will jeopardize the health of many people in the United Kingdom.
[Created on 11/22/2000]

Letter to the Department of Labor, Regarding Diesel Emissions Posing a Threat of Lung Cancer to Workers. (HRG Publication #1546)
Letter by Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 11/22/2000]

Letter to the National Bioethics Advisory Commission Regarding Their Report on the Challenges of Conducting Research in Developing Countries. (HRG Publication #1545)
The result is a document that, in its most critical parts, emphasizes process over outcome, thus leaving a number of loopholes that are likely to be exploited by less-than-scrupulous researchers.
[Created on 11/13/2000]

Letter to the Food and Drug Administration Updating the Number of Cases of Ischemic Coliitis Reported in Our 8/31/00 Petition. (HRG Publication #1544)
We have just obtained new information from the FDA about a sharp increase in the number of reported cases of ischemic colitis in people using alosetron. As of October 20th, reports received by the FDA now include an additional 28 cases of ischemic colitis, a more than doubling of the number of 26 cases we reported as of August 28th, for a total of 54 cases of ischemic colitis.
[Created on 10/30/2000]

Comments on the Final Rule Implementing the Prescription Drug Marketing Act of 1987/PDUFA. (HRG Publication #1543)
Unfortunately, Congress seriously erred in not mandating that all distributors, both unauthorized and authorized, be required to maintain such a pedigree for the drugs and bulk drug substances they sell. This has left the door open for unscrupulous distributors, even authorized ones, to launder counterfeit or substandard drugs that could be dispensed to an unsuspecting public.
[Created on 10/27/2000]

Petition to the Food and Drug Administration Requesting an Immediate Ban of All Uses of Phenylpropanolamine (PPA) in Over-the-Counter Products. (HRG Publication #1542)
We hereby petition the FDA for an immediate ban of all uses of phenylpropanolamine (PPA) in over-the-counter products (OTC) including as the active ingredient in appetite suppressants and as a decongestant in cough/cold preparations.
[Created on 10/19/2000]

Testimony Before the Food and Drug Administration NonPrescription Drugs Advisory Committee Meeting on Safety Issues of Phenylpropanolamine/PPA. (HRG Publication #1541)
We are asking for an immediate ban of all uses of PPA in over-the-counter products (OTC) including appetite suppressants and cough/cold preparations.
[Created on 10/19/2000]

Letter to the Editor in The Washington Post on Modifications to the Declaration of Helsinki. (HRG Publication #1540)
The real story behind the revised research ethics document known as the Declaration of Helsinki [news story, Oct. 8] is that the declaration was reopened with the specific intent of watering it down so that patients in experiments in poor countries would not have to be provided with the best scientifically proven therapies.
[Created on 10/17/2000]

News Release Concerning a New England Journal of Medicine Equivalency Study on Mother-Infant HIV Prevention Trials Done in Thailand Without Placebo. (HRG Publication #1539)
Had the researchers in the unethical studies designed theirs like the present study, hundreds of infants would have been saved because the mothers would have received a drug instead of placebo.
[Created on 10/4/2000]

Letter to the World Medical Association on Their New Draft Declaration of Helsinki Discussed at Their October 2000 Meeting. (HRG Publication #1538)
In most respects (see below), the draft Declaration is an improvement over the previous draft from May 2000 and a dramatic improvement over the disastrous version of March 1999. However, perhaps unintentionally, the current draft now makes no mention whatsoever of what interventions must be provided to patients during the trial, the very issue that prompted the revision of the Declaration in the first place.
[Created on 9/29/2000]

Comments Before the Food and Drug Association’s Dermatologic and Ophthalmic Drugs Advisory Committee Meeting on Isotretinoin (Accutane). (HRG Publication #1537)
Where industry interests have been at stake, the FDA has been innovative in interpreting the Food, Drug and Cosmetic Act to get drugs such as clozapine, thalidomide and dofetilide on the market. It is time for the agency use the same creativity to protect the public’s safety.
[Created on 9/18/2000]

Comments Before the Food and Drug Administration’s Public Meeting on the Prescription Drug User Fee Act (PDUFA). (HRG Publication #1536)
The solution is clear – to prevent further incursion into the FDA’s ability to effectively regulate prescription drugs requires public funding of the FDA. PDUFA-FDAMA is an unmistakable warning that user fees collected to finance the review of new drugs are bad public policy and that this scheme for funding the FDA must be regarded as a failed experiment.
[Created on 9/15/2000]

Petition to the Food and Drug Administration to Remove Alosetron (Lotronex) from the market. (HRG Publication #1533)
Public Citizen, a nationwide consumer organization with about 145,000 members, hereby petitions the Food and Drug Administration to immediately remove from the market the drug alosetron (Lotronex, Glaxo Wellcome), a drug for the treatment of Irritable Bowel Syndrome (IBS) because, according to new information we have just received from the FDA as of August 28, 2000, it has been associated with a total of at least 26 cases of ischemic colitis.
[Created on 8/31/2000]

Submission to the Food and Drug Administration Docket on Drugs That Present Difficulties for Compounding (HRG Publication #1532)
This change in the law has given compounding pharmacists an end run around the FDA approval process and has opened the door for unethical pharmacists to copy commercially available FDA-approved drugs and to perpetrate the dangerous quackery that is now rampant within the practice of pharmacy compounding.
[Created on 8/2/2000]

Article in the Annals of Internal Medicine on Physician Prescribing and Pharmacist Dispensing of Sterile Injection Equipment to Injection Drug Users. (HRG Publication #1535)
Article by Peter Lurie, M.D., M.P.H.
[Created on 8/1/2000]

Letter to the World Medical Association on Their May 2000 Version of the Declaration of Helsinki. (HRG Publication #1531)
However, we do remain deeply troubled by two aspects of the current draft Declaration.
[Created on 7/31/2000]

Letter to the Accreditation Council for Graduate Medical Education Regarding a Public Citizen Study Describing Medical Education Services Suppliers (HRG Publication #1530A)
Letter by Joseph Ross, Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 7/25/2000]

Medical Education Service Suppliers (MESS): a Threat to Physician Education (HRG Publication #1530)
The MESS industry’s revenue grew 19% between 1998 and 1999, totaling $643 million in U.S. revenue in 1999 for the 42 respondents (53%) who reported financial data. MESS’s averaged $15 million in 1999 U.S. revenue (range: $0.35-98 million). A total of $289 million, or 45% of the total reported revenue, was earned through providing grand rounds, symposia, or publications-related activities, with $115 million earned through providing grand rounds-related services.
[Created on 7/19/2000]

Letter Sent to The Lancet on Availability of Information on Thiazolidinediones. (HRG Publication #1534)
However, drug company websites are not the only, and certainly not the best, place to find unpublished data on drugs. Consulting readily available US governmental sources on the internet can lead to different conclusions regarding drug safety and efficacy. Using FDA data sources, we have just completed our own assessment of the thiazolinediones.
[Created on 7/15/2000]

Comments in Opposition to the Food and Drug Administration’s Pharmacy Compounding Advisory Committee in Opposition to the Pharmacy Compounding Provisions of the Food and Drug Administration Modernization Act (FDAMA) (HRG Publication #1529)
Public Citizen is opposed to the pharmacy compounding provisions of the Food and Drug Administration Modernization Act (FDAMA). These anti-scientific provisions of the law permit compounding pharmacists to conduct an “end run” around the FDA’s drug approval process.
[Created on 7/13/2000]

Testimony Before the Food and Drug Administration’s Endocrinologic/Metabolic and Non-Prescription Advisory Committee on Prescription to Over-the-Counter Switch. (HRG Publication #1528)
Even if the patient self-selection worked and arrived at a group of patients who met the defined eligibility criteria, these very criteria are seriously flawed. There is no evidence that the majority of those who are “eligible” for the drug will have any clinical benefit from taking 10 mg daily of Mevacor.
[Created on 7/13/2000]

Press Release Announcing a Journal of the American Medical Association Publishing of a Public Citizen Study Regarding Air Lead Levels in Candles. (HRG Publication #1527)
Press Release by Howard Sobel, M.D., Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 7/11/2000]

Request to the Occupational Safety and Health Administration to Reduce Exposure Levels for Chromium Based on a New Study Discovered Through the Freedom of Information Act. (HRG Publication #1525)
Letter by Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 7/11/2000]

Letter to the American Journal of Public Health Regarding Inclusion of Condoms and Counseling in Anti-HIV Microbicide Trials. (HRG Publication #1526)
Potts worries that more subjects would be needed for a study with condoms and counseling than for a study without these interventions. This can be addressed, however, by more actively recruiting participants and by using group sequential designs. Would Potts agree to a trial that was suboptimal scientifically in order to speed it up? If not, why is he willing to countenance studies that are suboptimal ethically for the same reason?
[Created on 7/1/2000]

Comments at a Food and Drug Administration Hearing on Switching Drugs From Prescription to Over-the-Counter. (HRG Publication #1524)
Before discussing the issue of new classes of diseases for which prescription to OTC switches might be considered, I will review some principles which, I believe, can be helpful when thinking about any Rx-to-OTC switch. Then, using these principles, I will discuss some of the reasons why the switch of cholesterol-lowering drugs should be opposed.
[Created on 6/28/2000]

Comments on the Department of Health and Human Services’ Inspector General’s Study on Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research (HRG Publication #1523)
We advocate a much stronger set of recommendations than is provided by the Inspector General’s Report; in particular, we advocate promulgating strong new regulations based, in part, on models that are being successfully employed in various settings and which are described in the Report. (See last paragraph of our comments)
[Created on 6/13/2000]

Letter to Center for Drug Evaluation and Research Urging the Food and Drug Administration (FDA) to Reject the Approval of Uprima (Apomorphine). (HRG Publication #1522)
We are writing to strongly urge the Food and Drug Administration (FDA) to reject the approval of Tap Holdings’ (a joint venture with Abbott Labs) Uprima (apomorphine), a drug for the treatment of erectile dysfunction (ED). Despite the fact that this drug has been shown to be only marginally effective at the lower dose and to have significant, life-threatening toxicity at the higher dose.
[Created on 6/5/2000]

Comments on the Draft Health and Human Services’ Inspector General’s Report: The External Quality Review of Psychiatric Hospitals. (HRG Publication #1521)
Comments by Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 5/23/2000]

Comments on the Department of Health and Human Services’ Inspector General’s Study of Adverse Event Reporting for Dietary Supplements. (HRG Publication #1568)
We are very concerned about the dangerous inadequacy of FDA’s adverse reaction reporting system for dietary supplements—wherein, for 1994 through 1999, the number of such reports filed with the American Association of Poison Control Centers (AAPCC) was 35,400, more than ten times higher than the approximately 3,000 reported to the FDA.
[Created on 4/24/2000]

Study of the Drug Industry’s Performance in Finishing Required Postmarketing Research (Phase IV) Studies. (HRG Publication #1520)
From 1990 through 1994 a total of 88 new molecular entities (NMEs) were approved which had at least one Phase IV commitment. Only 13 percent (11 of the 88) were classified by the FDA as complete as of December 1999 (see table 1). This means that for at least five and as long as 10 years after drug approval, all of the studies for 87 percent of these drugs had not been completed.
[Created on 4/13/2000]

Letter to the Food and Drug Administration (FDA) Asking for the Immediate Withdrawal of Propulsid (Cisapride) From the Market. (HRG Publication #1519)
We have obtained new FDA reports concerning 23 additional U.S. deaths since the beginning of this year from cardiac arrhythmias or sudden cardiac arrest/death associated with the use of the heartburn drug, Propulsid.
[Created on 4/11/2000]

Ranking of State Medical Boards’ Serious Disciplinary Actions in 1999. (HRG Publication #1518)
Report by Sidney Wolfe, M.D.
[Created on 4/5/2000]

Testimony Before an FDA Committee Regarding the FDA’s Categorization of “Morning Sickness” and “Leg Edema” During Pregnancy as Conditions for Which Dietary Supplement Manufacturers Might Promote Their Products (HRG Publication #1517)
Under the dangerous provisions of DSHEA, that categorization allows dietary supplement manufacturers to promote products as treatments of those conditions without first proving that the products are safe and effective.
[Created on 3/30/2000]

Letter to the Department of Health and Human Services Urging That They Implement and Enforce the Code of Ethics for Government (HRG Publication #1516)
It is urgent for you and other leaders in HHS—and all government agencies—to re-read and strongly urge the implementation and enforcement of a 1958 Congressional Resolution entitled The Code of Ethics for Government Service (175 72 Stat B12, 1958) which states that “Any person in Government Service should put loyalty to the highest moral principles and to country above loyalty to persons, party or Government department.”
[Created on 3/22/2000]

Letter to the FDA Requesting a Criminal Investigation of Warner Lambert/Parke Davis for What Appears to be Illegally Delaying the Submission of Data Known to the Company Before Troglitazone Was Marketed. (HRG Publication #1515)
This letter is to request the opening of a criminal investigation of Warner-Lambert/Parke-Davis for what appears to be illegally delaying the submission of a compilation of data known to the company before marketing had begun—clearly showing troglitazone-induced liver toxicity—until after the drug was marketed.
[Created on 3/14/2000]

Petition to the Food and Drug Administration Requesting That It Immediately Require Labeling for the Diabetes Drugs Troglitazone (Rezulin), Rosiglitazone (Avandia) and Pioglitazone (Actos) (HRG Publication #1514)
Class efficacy issues include the lack of efficacy compared to previously available drugs, sulfonylureas, and the deterioration of blood sugar levels when patients are switched from other oral anti-diabetic drugs to the glitazones. Safety issues include liver toxicity, effects on heart function, weight gain, edema, anemia, low blood pressure, elevated lipid levels, and possible changes in progesterone levels.
[Created on 3/7/2000]

Letter to the FDA Concerning the United Kingdom’s Committee on Safety of Medicine’s Recent Warning About Potentially Serious Drug Interactions Between St. John’s Wort and a Large Number of Other Drugs. (HRG Publication #1513)
British physicians and patients are now being forcefully warned, for many more drugs than American physicians or patients, about potentially serious, clinically important drug interactions between the unregulated herbal St. John’s Wort (Hypericum perforatum) and a large number of prescription drugs.
[Created on 3/2/2000]

Comments on a Food and Drug Administration Survey on the Status of Useful Written Prescription Drug Information for Patients, Requesting That It Be Redesigned. (HRG Publication #1512)
Because inadequate access to scientifically accurate drug information is a major cause of the inappropriate use of prescription drugs, resulting in serious personal injury to consumers and related costs to the healthcare system, Public Citizen’s Health Research Group strongly urges the following:
[Created on 2/29/2000]

Testimony Before the Senate Committee on Foreign Relations Subcommittee on African Affairs Proposing a Six-Point Plan to Address the HIV Epidemic in Sub-Saharan Africa. (HRG Publication #1511)
Testimony by Peter Lurie, M.D., M.P.H.
[Created on 2/24/2000]

Petition to the Consumer Product Safety Commission to Ban and Recall Candles With Lead-Containing Wicks. Included is a 6/8/00 Letter Updating Statistics. (HRG Publication #1510)
Petition by Howard Sobel, M.D., M.P.H., Sidney Wolfe, M.D. and Peter Lurie, M.D., M.P.H.
[Created on 2/24/2000]

Letter to the Editor in The Washington Post on the Death of Jesse Gelsinger in the University of Pennsylvania Gene Therapy Study. (HRG Publication #1509)
Researchers are required to report adverse events in all clinical trials for experimental drugs to the Food and Drug Administration (FDA). Debate rages over whether gene therapy investigators should be required to report such events to the National Institutes of Health, which can disclose these events to the public, in addition to reporting them to the FDA, which cannot.
[Created on 2/14/2000]

Letter to the UNAIDS Program on Their Guidance Document on Ethical Considerations in HIV Preventive Vaccine Research. (HRG Publication #1508)
But the current version has instead opted for a non-prescriptive approach, simply laying out the options in many instances, and leaving large loopholes that we believe most researchers will exploit.
[Created on 2/11/2000]

Letter to the Food and Drug Administration Regarding Their Final Regulations on Dietary Supplements and Their Definition of Adverse Effects of Pregnancy. (HRG Publication #1507)
Now, the same agency seems to have thrown caution to the wind and appears willing to endanger unborn babies by pretending that medical conditions such as morning sickness and edema of pregnancy are not diseases, thereby allowing the marketing of dietary supplements/herbals that have not been tested for safety.
[Created on 2/3/2000]

Survey of Doctor Disciplinary Information on State Medical Board Web Sites (HRG Publication #1506)
Report by Demian Larry, Sidney Wolfe, M.D. and Peter Lurie, M.D., M.P.H.
[Created on 2/2/2000]

Comments Concerning the Food and Drug Administration’s Proposed Regulations on Powdered Latex Gloves and Their Rejection of Our Petition to Ban the Gloves. (HRG Publication #1505)
Comments by Sidney Wolfe, M.D.
[Created on 1/27/2000]

1999

Comments on the International Conference on Harmonization’s Draft Guidance on Choice of Control Group in Clinical Trials. (HRG Publication #1503)
The Draft Guidance on Choice of Control Group in Clinical Trials, prepared as part of the International Conference on Harmonisation (ICH), is a clear attempt by the Food and Drug Administration (FDA) to spread its pro-placebo-controlled trial ideology globally. This proselytizing intent was made clear at an FDA meeting on the use of placebos in clinical trials in which we participated in April of this year.
[Created on 12/23/1999]

Letter to the Editor in the Journal of the American Medical Association in Response to an Article on the Safety of Food and Drug Administration Approved Drugs Which Were Withdrawn (HRG Publication #1502)
Letter by Peter Lurie, M.D., M.P.H. and Larry Sasich, Pharm.D., M.P.H.
[Created on 12/22/1999]

Report With the Treatment Advocacy Center on the Results of a Survey of Radio and Television Stations on Threats to the Safety of Their Personnel by Individuals With Severe Mental Illness (HRG Publication #1501)
Report by E. Fuller Torrey, M.D., Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 12/15/1999]

Letter in The Lancet Detailing Unethical Nevirapine Trials. (HRG Publication #1500)
Although Laura Guay and colleagues’ study on the effectiveness of nevirapine in reducing perinatal HIV-1 transmission offers hope for reducing the enormous global toll of HIV-1 infection, their work remains deeply unethical. For 14 months after an antepartum and intrapartum regimen of zidovudine was shown in Thailand to reduce HIV-1 transmission by 51%,2 Guay and colleagues continued to enrol participants without providing antepartum antiretroviral drugs.
[Created on 11/20/1999]

Letter to Advertising Age Concerning an Ad in the 11/15/99 Issue of the Magazine Portraying a Dead Body With a Sign Advertising the Organs Inside as a “Liquidation Sale.” (HRG Publication #1499)
I was appalled to see the ad which ran opposite page 38 in this week’s (November 15th) issue of the magazine portraying a dead body with a sign advertising the organs inside in a liquidation sale. It is the most offensive and tasteless ad that I–a reader of Advertising Age for the past 20 years–have ever seen, anywhere. It is a statement that the standards for ad acceptance by Advertising Age have hit rock bottom.
[Created on 11/19/1999]

Letter to the National Institutes of Health Regarding Their Position on Future Studies of HIV-Infected Pregnant Women Since Nevirapine Was Shown to Reduce the Risk of Transmission. (HRG Publication #1498)
One might think that the development of this extremely cost-effective regimen ($40 per infant life saved) would result in an immediate change in NIH policy. But testimony delivered by Jack Killen of the National Institute of Allergy and Infectious Diseases before the National Bioethics Advisory Commission on September 16, 1999 suggests otherwise.
[Created on 11/3/1999]

Comments Before the National Toxicology Program’s Public Meeting on the Report On Carcinogens Review Process. (HRG Publication #1497A)
Comments by Peter Lurie, M.D., M.P.H.
[Created on 10/21/1999]

Letter to the Food and Drug Administration’s Office of Surveilance and Biometrics Concerning the Global Harmonization’s Task Force’ Proposal for Reporting Use Errors With Medical Devices (HRG Publication #1497)
Letter by Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 10/15/1999]

Letter to the Editor in the Chicago Tribune, Responding to an Editorial Concerning South Africa’s Decision to Review its Law Seeking to Procure Affordable AIDS Drugs. (HRG Publication #1495)
Only someone living in a country where most people have access to anti-HIV drugs could come to that conclusion. The brutal fact is that today in South Africa AIDS will claim more than 400 people. Some of these lives could have been prolonged by medications that are readily available in the U.S. but are unaffordable in South Africa and most other developing nations due to drug company price gouging.
[Created on 9/25/1999]

Report Detailing Occupational Safety and Health Administration Enforcement Actions From 1972 Through 1998. (HRG Publication #1494)
Report by Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 9/6/1999]

Press Release Reacting to Two Articles in the New England Journal of Medicine on Attempts to Rewrite the World Medical Association’s Declaration of Helsinki. (HRG Publication #1493)
Public Citizen, reacting to two articles in this week’s New England Journal of Medicine, today criticized attempts to rewrite the World Medical Association’s Declaration of Helsinki, which governs international research ethics. As Dr. Robert Levine, the author of one of the articles, admits, the Declaration’s requirements are routinely violated.
[Created on 8/11/1999]

Opinion Appearing in USA Today Concerning the Promotion of Off-Label Uses of Drugs. (HRG Publication #1492A)
McNeill states that the placebo-controlled trials of shorter courses of zidovudine to prevent perinatal HIV transmission in Africa and Asia were quicker than active controlled trials and will save more lives. These assertions are incorrect for four reasons.
[Created on 8/9/1999]

Letter to the Department of Heath and Human Services Concerning Pfizer’s Campaign to Counter the Centers for Disease Control Recommendations for Treatment of Ear Infections. (HRG Publication #1491)
We are writing to make you aware of an apparent effort by Pfizer, Inc. to counter the CDC guidelines for the treatment of ear infections in children and cause millions of dollars of unnecessary spending on antibiotics.
[Created on 8/3/1999]

Letter in the Medical Journal of Australia on Speed of Conducting Trials of Perinatal HIV Transmission Prevention. (HRG Publication #1492)
McNeill states that the placebo-controlled trials of shorter courses of zidovudine to prevent perinatal HIV transmission in Africa and Asia were quicker than active controlled trials and will save more lives. These assertions are incorrect for four reasons.
[Created on 8/2/1999]

Statement Before the Committee on Government Reform Subcomittee on Criminal Justice, Drug Policy and Human Resources, House of Representatives on Compulsory Licensing and Parallel Imports of HIV/AIDS Medicines. (HRG Publication #1490)
Recently, the pharmaceutical industry has questioned compulsory licensing(1) and parallel imports(2) on the grounds that these measures might 1. lead to the development of strains of the human immunodeficiency virus (HIV) that are resistant to currently available medications; and 2. result in decreased pharmaceutical company research and development (R&D). This testimony will address these two claims in turn.
[Created on 7/22/1999]

Comments Concerning the Department of Health and Human Services’ Inspector General’s Report on External Review of Hospital Quality by the Joint Commission on the Accreditation of Healthcare Organizations/JCAHO. (HRG Publication #1489)
Comments by Sidney Wolfe, M.D. and Lauren Dame, J.D., M.P.H.
[Created on 7/20/1999]

Press Release and Materials Concerning Publication of a Journal of the American Medical Assocation Article Comparing Quality of Care in Investor-Owned vs Not-for-Profit HMOs. (HRG Publication #1488)
Press Release by David Himmelstein, M.D., Ida Hellander, M.D. and Sidney Wolfe, M.D.
[Created on 7/13/1999]

Letter Entitled “Tuskegee as a Metaphor” That Appeared in Science Magazine Relating to Ethics of Studies on AZT and Needle Exchange. (HRG Publication #1487)
We invoked the Tuskegee study analogy in the perinatal AZT trials because (i) both were prospective studies in which participants were denied known effective treatments; (ii) both were conducted or funded by the U.S. Public Health Service; (iii) both involved people of color; (iv) both included violations of informed consent.
[Created on 7/2/1999]

Op-Ed in the Western Journal of Medicine Entitled Proposed Revisions to the Declaration of Helsinki: Paving the Way for Globalization in Research. (HRG Publication #1496)
A front-page article in the The New York Times in June described a horrifying scenario: Cornell University researchers, using National Institutes of Health (NIH) funds, have followed dozens of Haitians infected with the HIV for years with-out providing the protease inhibitors and other medications that have revolutionized the care of patients with HIV.
[Created on 7/1/1999]

Letter to the Editor in The New York Times Concerning Ethics in International Research on HIV Progression. (HRG Publication #1486)
Even after less expensive regimens of the drug AZT that are designed for poor countries have been proved to reduce H.I.V. transmission from mother to infant, this regimen is still unavailable to most people who could benefit from it, including residents in the countries that were host to the trials (front page, June 6). The National Institutes of Health is supporting a new generation of mother-infant studies in southern Africa in which the less expensive regimens are still not being provided.
[Created on 6/6/1999]

Letter to the Food and Drug Administration to Immediately Ban the Antibiotic Trovafloxacin (Trovan). (HRG Publication #1485)
We hereby petition the Food and Drug Administration (FDA) as authorized by 21 U.S.C. , section 355 (e) of the Federal Food, Drug and Cosmetic Act to immediately ban the widely-used antibiotic, TROVAN (trovafloxacin, Pfizer), before more patients die, require a liver transplant or are otherwise injured from liver toxicity caused by this drug.
[Created on 6/3/1999]

Letter to the Editor in The Washington Post Concerning Dangerous Drug Information Found on Their Web Site Entitled InteliHealth Which is Associated With Johns Hopkins University. (HRG Publication #1484)
Readers should be warned that The Post‘s new health Web site, www.washingtonpost.com/health, launched April 13, included potentially dangerous drug information. Information on the site, provided by Inteli-Health, Inc., in association with Johns Hopkins, is out-of-date and inaccurate.
[Created on 6/1/1999]

Editorial in the South African Medical Journal Entitled “Denying Effective Antiretroviral Drugs to HIV-Positive Pregnant Women–the National Government’s Flawed Decision.” (HRG Publication #1483A)
Editorial by Peter Lurie, M.D., M.P.H.
[Created on 6/1/1999]

Response to an Article in The Lancet Regarding Maternal-Infant Transmission of HIV/AIDS Prevention Trials. (HRG Publication #1483)
The so-called consensus statement on perinatal HIV prevention trials 1 is the first of several attempts to greatly undermine existing protections for human trial participants, especially in as much as they relate to the rights of participants from developing countries.
[Created on 5/29/1999]

Statement Concerning Senator Crapo’s Legislation That Could Keep Patients in the Dark About Risks of Prescription Drugs. (HRG Publication #1482)
The legislation seeks to derail a proposed Food and Drug Administration (FDA) regulation due to take effect June 1. This regulation would require the distribution of written information, or Medication Guides, to patients, meeting FDA standards for content and accuracy, for five to 10 drugs per year that “pose a serious and significant public health concern.”
[Created on 5/21/1999]

Statement About a Food and Drug Adminstration Article in the Journal of the American Medical Association Regarding Recently Withdrawn Drugs and the Safety of Newly Approved Drugs. (HRG Publication #1481)
None of these drugs were breakthrough drugs and the serious safety concerns should have prevented their approval in the cases of Redux, Posicor, and Duract and a much earlier market withdrawal for Seldane. FDA’s conclusion that there is no problem associated with these drug safety withdrawals should not be taken seriously because to do so will continue to jeopardize the safety of American patients.
[Created on 5/12/1999]

Statement Before the Pharmacy Compounding Advisory Committee Making Recommendations Regarding Bulk Drug Substances Approved for Pharmacy Compounding and Marketing These to Consumers. (HRG Publication #1480)
There is evidence for the abuse of pharmacy compounding. The nomination of dimercapto-1-propanesulfonic acid (DMPS), a chelating agent, and piracetam, a “brain booster” on the list of 20 bulk drug substances that may be used in pharmacy compounding are clear examples of this abuse.
[Created on 5/6/1999]

Citizen’s Petition With the National Women’s Health Network to the Food and Drug Administration to Change the Labeling on Tamoxifen (Nolvadex). (HRG Publication #1479)
When tamoxifen, a known human carcinogen, is prescribed to healthy women, there must be compelling evidence of great benefit. Although we are not convinced that the benefits of tamoxifen outweigh its risks in this population, tamoxifen has been approved and is now being prescribed for the reduction in incidence of breast cancer.
[Created on 5/4/1999]

Ranking of State Medical Boards’ Serious Disciplinary Actions in 1998. (HRG Publication #1478)
Report by Sidney Wolfe, M.D.
[Created on 4/9/1999]

Letter to the World Medical Association Expressing Alarm at the Current Draft Revised Version of the Declaration of Helsinki. (HRG Publication #1477)
Apparently reacting to the fact that perinatal HIV transmission trials, in which drugs of known efficacy were withheld from HIV-positive pregnant women, were in clear violation of the current version of the Declaration, researchers have reacted by seeking to change the ethics rules to comply with the scientific studies they wish to conduct, rather than revising their studies to be ethical.
[Created on 3/29/1999]

Statement Before the Food and Drug Administration Endocrine and Metabolic Drugs Advisory Committee Meeting Advising Them to Withdraw Troglitazone From the U.S. Market. (HRG Publication #1476)
John Doe was an otherwise healthy 45 year old Washington D.C. policeman who was started on Rezulin in the late summer of 1998, preceded by perfectly normal liver tests. Within a week after he started taking the drug, well before he was due for another liver test, he became seriously ill, was hospitalized at Johns Hopkins with acute liver failure.
[Created on 3/26/1999]

Comments to the Food and Drug Administration on Their List of Bulk Drug Substances That May Be Used in Pharmacy Compounding. (HRG Publication #1475)
The FDA by not vigorously enforcing existing law against compounding pharmacists who were engaging in the manufacturing of unapproved new drugs has allowed a second class of drugs to exist. Now, under the weaker FDAMA, many of what were previously violations have been legalized.
[Created on 3/23/1999]

Materials on the Breaux-Thomas Medicare Plan Which Supports Subsidies for Drug Firms and HMOs and Cuts Back on Health Care for Senior Citizens and Others Who Depend on the Program. (HRG Publication #1474)
Press Release by Maura Keeley and Sidney Wolfe, M.D.
[Created on 3/16/1999]

Letter and Documents Sent to the Food and Drug Administration Urging Them to Immediately Recall All Lots of Abbokinase Because of Possible Contamination With Infectious Agents. (HRG Publication #1473)
The purpose of this letter is to strongly urge you to recall immediately all lots of Abbokinase, a widely-used clot-busting drug—$250 million in sales in 1998 for Abbott Laboratories of Abbokinase(1)—and to seize all raw materials and in-process precursors used to make Abbokinase, as recommended by FDA field officials, because of possible contamination with infectious agents.
[Created on 2/10/1999]

Statement Before the Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee Urging That They Not Approve Dofetilide (Tikosyn) to Prevent Recurrent Arrythmias. (HRG Publication #1472)
Despite not being allowed access to these data and the fact that the peer reviewed medical literature is not an adequate substitute for the FDA reviews of safety and efficacy we do have serious concerns based on a review of the published literature about the safety of dofetilide because of its proarrhythmic effects and association with torsade de points (a potentially life-threatening heart rhythm disturbance).
[Created on 1/28/1999]

Letter to United Nations Program on HIV/AIDS Commenting on Their Guidance Document on Ethical Considerations in International Trials of HIV Vaccines. (HRG Publication #1471)
The elaborate, time-consuming and expensive UNAIDS consultation on the ethics of HIV vaccine trials seems about to come to its pre-ordained conclusion: in areas of controversy, the Guidance Document in effect provides researchers with a blank check to proceed as they would without the consultation, abrogating existing ethical doctrines, as long as they can convince local researchers to go along.
[Created on 1/15/1999]

1998

Op-Ed in The Washington Post Entitled Troubling Climate at the FDA Which Discusses Medical Officer’s Opinions of the Drug Approval Process. (HRG Publication #1469)
The results were startling. Nineteen medical officers mentioned 27 drugs that had been approved by the FDA in the past three years even though the medical officer – the person most familiar with all the data on the drug – opposed approval. It is likely that had more medical officers responded, even more such drugs would have been mentioned.
[Created on 12/30/1998]

Letter to the Food and Drug Administration Concerning a Study in the New England Journal of Medicine Amplifying Our Concerns About the Safety of Cilostazol (HRG Publication #1468)
Three members of the FDA’s Cardiovascular and Renal Advisory committee voted against approving the drug due to these safety problems which were evident in the studies presented to that committee on July 9, 1998. These included abnormal electrocardiograms, increased heart rate, increased ventricular arrhythmias (premature ventricular contractions) and a suggestion, though not statistically significant, of increased mortality, even though the longest time studied on the drug was just six months.
[Created on 12/30/1998]

Statement Before the Food and Drug Administration Before the FDA’s Science Forum on Biotechnology Regarding Threats to Safe and Effective Regulation of Products. (HRG Publication #1467)
There are several important functions of CBER research: to facilitate the approval of safe and effective products; to support decisions to withdraw products found to be unsafe; and to support informed decision-making in the prevention of and response to public health crises. All of these functions are threatened by cutbacks in funds and the number of people devoted to research.
[Created on 12/9/1998]

FDA Medical Officers Report Lower Standards Permit Dangerous Drug Approvals (HRG Publication #1466)
Nineteen Medical Officers identified a total of 27 new drugs in the past three years that they reviewed that they thought should not have been approved but were approved. Five Medical Officers identified a total of six new drugs that they reviewed in the past three years that they thought should have been approved but were not approved.
[Created on 12/2/1998]

Statement Before the Food and Drug Administration’s Arthritis Drugs Advisory Committee on the Nonsteroidal Anti-Inflammatory Drug Celecoxib. (HRG Publication #1465)
There needs to be clear evidence from comparative long-term, higher dose randomized trials in which celecoxib or any other COX-2 type of anti-inflammatory drug is compared to the least dangerous of these older drugs, ibuprofen, that there is a statistically significantly lower amount of serious GI complications such as perforations, ulcers or bleeding with the COX-2 inhibitor drug.
[Created on 12/1/1998]

Press Release Concerning FDA’s Approval of Tamoxifen to Reduce Incidence of Breast Cancer in Healthy Women Puts Women at Risk (HRG Publication #1464)
Public Citizen’s Health Research Group finds it incredible that the Food and Drug Administration (FDA) has approved tamoxifen, a drug that is a known human carcinogen, to reduce the risk of breast cancer in women who are at a so-called high risk of the disease. Tamoxifen can induce tumors by altering a woman’s DNA and may cause other types of cancers years later.
[Created on 10/29/1998]

Statement Before the Food and Drug Administration’s Pharmacy Compounding Advisory Committee Detailing Problems With its Regulation of Pharmacy Compounding. (HRG Publication #1463)
The pharmacy compounding provision, along with numerous other aspects of FDAMA, has for the first time since the passage of the Pure Food and Drug Act of 1906 weakened, rather than strengthened, the laws intended to protect consumers.
[Created on 10/14/1998]

Comments on the Implementation of the Food and Drug Administration Modernization Act and Protesting the Fact That Consumer Groups Were Not Invited to the Hearing. (HRG Publication #1462)
While numerous provisions of FDAMA directly and indirectly weaken FDA authority to protect consumers from unsafe drugs and medical devices, badly needed new enforcement powers – civil monetary penalties for any drug-related violation of the Food Drug and Cosmetic Act, giving the FDA authority to require mandatory recalls and to be promptly notified of voluntary ones, and subpoena power for drug and other regulated industry records – were not included in the Act.
[Created on 10/7/1998]

Press Release Detailing a Study in the Journal of the American Medical Association Concerning Discrimination in U.S. Kidney Transplant Practices. (HRG Publication #1461)
Press Release by Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 10/6/1998]

Comments on Proposed Food and Drug Administration Survey Entitled FDA: Attitudinal and Behavioral Effects of Direct-to-Consumer Advertising of Prescription Drugs. (HRG Publication #1460)
Without the protection of objective drug information consumers are naked in the pharmaceutical marketplace, subject to the misleading influence of billions of dollars worth of slick advertising, that promotes new drugs, that may be less safe and effective and more expensive than older drugs or non-drug treatments.
[Created on 9/28/1998]

Press Release Supporting the “Prescription Drug Fairness for Seniors Act of 1998” as It Means Badly Needed Drug Price Relief for Medicare Beneficiaries. (HRG Publication #1459)
The “Prescription Drug Fairness for Seniors Act of 1998” levels the drug-price playing field for Medicare recipients by allowing them to pay for their prescriptions based on the same price that is available to federal agencies from the Federal Supply Schedule — a savings that could amount to as much as 40 percent.
[Created on 9/25/1998]

Letter to the FDA Urging That They Reject the Application for Approval of Cilostazol (Pletal) as There Are Other Remedies for a Non-Threatening Condition (HRG Publication #1458)
We strongly urge you to reject the application for approval of cilostazol (Pletal), a drug to treat intermittent claudication, a chronic, non-life-threatening condition for which there are alternative solutions, including exercise, that do not involve the multitude of known and potentially life-threatening risks that exist with cilostazol.
[Created on 9/18/1998]

HRG Comments on Section 406(B) of the FDA Modernization Act Of 1997 (HRG Publication #1457)
The irony in this request for comments lies in the fact that the purpose of the FFDCA was consumer protection, while the clear intent of FDAMA ’97 is to further the economic well-being of multinational pharmaceutical and medical device companies at the expense of the public’s safety.
[Created on 9/16/1998]

Smokescreen: Double Standards of U.S. Tobacco Companies in International Cigarette Labeling. (HRG Publication #1456)
Report by Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 9/9/1998]

Letter to the Food and Drug Administration Supporting Consumer Representatives on the Pharmacy Compounding Advisory Committee. (HRG Publication #1455)
We know that you have finalized your selections for members of the advisory committee, and we regret that we did not focus earlier on Section 127’s clear requirement of a representative from consumer organizations. Nonetheless, we believe that the statute mandates that such a representative be placed on the committee.
[Created on 8/31/1998]

Letter to the Medicines Control Agency, United Kingdom, Urging Them to Require Important Warnings on Labeling of Sildenafil (Viagra). (HRG Publication #1454)
Public Citizen’s Health Research Group is writing to urge the Medicines Control Agency to require important warnings on the labeling of the drug sildenafil (Viagra) that have been omitted from the drug’s labeling in the United States.
[Created on 8/27/1998]

Letter to the FDA Supporting Dr. Robert Misbin Concerning a Letter He Had Written to The Washington Post Criticizing FDA Policies. (HRG Publication #1453)
Letter by Sidney Wolfe, M.D.
[Created on 8/25/1998]

Letter Urging the Therapeutic Products Program in Canada to Require Warnings on Sildenafil (Viagra) (HRG Publication #1452)
Public Citizen has petitioned the United States Food and Drug Administration (FDA) on July 1, 1998 and again on August 20, 1998 to correct the dangerously deficient labeling of sildenafil in the U.S. These two petitions are attached for your reference.
[Created on 8/24/1998]

Letter to the Food and Drug Administration Urging Them to Immediately Convene an Advisory Committee to Review Various Serious Problems Related to the Use of Sildenafil (Viagra). (HRG Publication #1451)
One purpose of this letter is to demand that the FDA immediately convene a meeting on Viagra of its cardiovascular advisory committee—a committee which was completely bypassed during the dangerously-rushed six months between the submission of the new drug application for Viagra to the FDA and its approval.
[Created on 8/20/1998]

Letter to USA Today, Demanding Action Against All USA Today Employees Responsible for the Glaxo Wellcome Special Edition of the Paper Distributed at an AIDS Conference and Promoting Glaxo Wellcome (HRG Publication #1450)
When conference attendees picked up their USA Today they saw what looked to them like the normal front page of USA Today. This pseudoedition used the overall design and logo of a regular issue of USA Today to hawk Glaxo products. There is little reason to expect better from a for-profit pharmaceutical manufacturer, but for a major international newspaper to sell its name and reputation in the service of increased profit is a craven violation of journalistic ethics.
[Created on 7/29/1998]

Petition to the Food and Drug Administration to Ban Troglitazone (Rezulin) Due to its Causing Several Cases of Liver Failure. (HRG Publication #1449)
We have obtained information from the FDA that as of June 5, 1998, there had been at least 21 deaths from liver failure and three patients requiring liver transplants caused by the recently-approved diabetes drug, troglitazone (Rezulin-Parke- Davis/Warner Lambert).
[Created on 7/27/1998]

Statement Before the Institute of Medicine on the Safety of Silicone Breast Implants. (HRG Publication #1448)
Statement by Sidney Wolfe, M.D.
[Created on 7/24/1998]

Comments on Food and Drug Administration Proposed Regulation on Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics and Devices. (HRG Publication #1447)
Any promotional material for an off-label use must be false or misleading if it contains insufficient evidence to gain FDA approval and thus by definition poses a significant risk to the public’s health.
[Created on 7/23/1998]

Report on the International Comparison of Prices of Antidepressant and Antipsychotic Drugs. (HRG Publication #1446)
All countries studied except the US have national health insurance that may allow them to negotiate lower prices with pharmaceutical companies. Even with negotiated prices, the companies make a reasonable profit, e.g. 20% for all drugs in the UK. By contrast, the profit margin for these same eight drugs in US is estimated to be 42%.
[Created on 7/15/1998]

Petition to the Food and Drug Administration to Change the Labeling and Other Sources of Information on Sildenafil (Viagra) to Reflect Problems With the Drug. (HRG Publication #1445)
The purposes of this letter are to petition FDA to change the labeling and other sources of information about Viagra to add important information about the drug’s dangers currently missing from such sources and to warn doctors and patients that a substantial proportion of patients using the drug are unwittingly using it to treat impotence or other types of sexual dysfunction which are probably adverse reactions caused or worsened by other drugs known to impair sexual function.
[Created on 7/1/1998]

Comments on the Department of Health and Human Services’ Inspector General’s Reports on Institutional Review Boards. (HRG Publication #1443)
The increasingly large number of violations found by FDA investigators in IRB-approved informed consent documents, the dangerous lack of on-site inspections for HHS-funded research by NIH’s Office of Protection from Research Risks (OPRR), the rise of for-profit IRBs—much of whose work is to monitor research done by for-profit clinical trials companies—and many other problems documented in these reports believe the conclusion of no widespread abuse.
[Created on 6/11/1998]

Petition to the Food and Drug Administration to Immediately Stop the Distribution of Dangerous, Misleading Prescription Drug Information to the Public. (HRG Publication #1442)
Had Cory’s parents received a PIL that was consistent with or derived from imipramine’s approved product labeling Cory’s parents would have made the decision not to administer the drug and Cory would be alive today. There will continue to be more ‘Corys’ until the public is guaranteed access to objective information, written in non-technical language, that places the risks of prescription drugs in a context that is useful to the general public.
[Created on 6/9/1998]

Statement on the Withdrawal of Mibefradil (Posicor) From the Market. (HRG Publication #1441)
Mibefradil (Posicor) is an example of the risks that the American public will continue to face in the future because of the flood of new drugs that the FDA has rushed to approve in the last several years.
[Created on 6/8/1998]

Statement Concerning a Report by the Center for Science in the Public Interest on Threats to Antibiotic Effectiveness. (HRG Publication #1440)
There are several indisputable facts concerning the increasing threat to the effectiveness of antibiotics: 1/ There is massive overuse/misuse of antibiotics in humans and animals. 2/ There are rapidly-increasing, health-threatening numbers of antibiotic resistant bacteria in proportion to increasing use and the concomitant misuse (a major component of total use) of these drugs.
[Created on 5/28/1998]

Comments Regarding the Food and Drug Administration’s Proposed Rule on Mutual Recognition of FDA and European Community Member State Conformity Assessment Procedures. (HRG Publication #1439)
One key feature missing in the proposed rule is mechanisms for the public to participate in the equivalence determination process. Whenever a federal agency seeks to determine that the regulatory system used by a foreign country is equivalent to the regulatory system of the United States, public participation is crucial. Yet, FDA has not spelled out any role for the public or for consumer and non-government health organizations in the equivalence assessment process.
[Created on 5/11/1998]

Testimony Before the U.S. House of Representatives’ Committee on Government Reform and Oversight on Inappropriate Use of Placebos in Human Experiments. (HRG Publication #1438)
These regulations apply as long as federal funds are utilized, regardless of where the research occurs. Yet the use of placebo controls in such situations is common. Rothman and Michels have identified a large number of studies using placebos after effective treatment was identified in areas as diverse as rheumatoid arthritis, antidepressants, congestive heart failure, hypertension and onchocerciasis (river blindness).
[Created on 4/22/1998]

Comments on the Food and Drug Administration’s Draft Guidance for Industry on Promoting Medical Products by Healthcare Organizations or Pharmacy Benefits Management Companies/PBMs (HRG Publication #1437)
Public Citizen concurs with the FDA, as the agency stated in this draft guidance, that drug companies’ promotional activities may create a public health risk. When physicians and consumers are persuaded to use new drugs with unproven health benefits the quality of healthcare is lowered when the use of older drugs that have been shown in rigorous clinical trials to improve health outcomes are declining.
[Created on 4/8/1998]

Ranking of State Medical Boards’ Serious Disciplinary Actions in 1997. (HRG Publication #1436)
Report by Sidney Wolfe, M.D.
[Created on 4/8/1998]

Statement Before the District of Columbia Control Board on Medical Malpractice. (HRG Publication #1434)
Testimony/Presentation by Sidney Wolfe, M.D.
[Created on 2/18/1998]

Press Release on Centers for Disease Control Study Which Needlessly Infected Dozens of Thai Infants by Using Placebo in a Study of HIV Prevention. (HRG Publication #1433)
For almost a year, Public Citizen has been waging a campaign against over a dozen studies in developing countries, most funded by the CDC and National Institutes of Health (NIH), that denied HIV-positive pregnant women access to AZT, a drug that, when given for somewhat longer periods during pregnancy and intravenously during delivery, reduces mother-to-infant HIV transmission by two-thirds.
[Created on 2/18/1998]

Petition to the Food and Drug Administration to Ban Cornstarch Powder on Latex Gloves. (HRG Publication #1432)
Petition by Sidney Wolfe, M.D. and Christine Dehlendorf.
[Created on 1/7/1998]

1997

Hospital Violations of the Emergency Medical Treatment and Labor Act (HRG Publication #1431A)
This report is the fifth in a series tracking the Department of Health and Human Services’ enforcement of the Emergency Medical Treatment and Labor Act, which prohibits “patient dumping” – a practice in which hospitals deny medical screening and/or treatment to emergency patients or women in labor, often by transferring them, in unstable conditions, to another hospital.
[Created on 12/1/1997]

Response to the Institute of Medicine’s Report on Halcion. (HRG Publication #1431)
The Institute of Medicine (IOM) report, done in a hurried manner, is a waste of taxpayers dollars in that many of the questions it was asked/paid to answer by the Food and Drug Administation (FDA), had already been answered by the FDA before the committee’s process had barely begun.
[Created on 11/13/1997]

Letter Concerning Unethical Placebo-Controlled Studies on HIV-Positive Pregnant Women in Developing Countries (HRG Publication #1430)
In the past three weeks we have obtained new information concerning the unethical studies on HIV-positive pregnant women in developing countries being funded by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) which strengthens the case against your ill-advised decision to allow these studies to continue with placebo-controlled arms.
[Created on 10/23/1997]

Comments on Food and Drug Administration’s Draft Guidance for Industry on Direct to Consumer Advertising. (HRG Publication #1429)
The combination of the FDA’s failure to issue regulations on direct-to-consumer (DTC) prescription drug advertising and the agency’s draft guidance for industry on DTC ads, allowing radio and television ads for prescriptions drugs, is an ill-advised policy that promotes the distribution of misleading information to the public.
[Created on 10/14/1997]

Press Release and Editorial in the New England Journal of Medicine Regarding Release of an Article and Other Editorials on U.S. Double Standard on HIV Research. (HRG Publication #1427)
In a September 18, 1997 article in the New England Journal of Medicine, two Public Citizen Health Research Group physicians attack the U.S. Government for funding unethical HIV experiments in some of the world’s poorest countries and assert that safer alternative research methods have been largely ignored.
[Created on 9/17/1997]

Statement on Misleading Direct-to-Consumer Advertising by Schering for loratadine (Claritin). (HRG Publication #1426)
Predictably, it has taken only 11 days for a major drug company to violate Federal law and regulations with misleading direct-to-consumer (DTC) TV ads for a prescription drug, supporting the contention that the true purpose of TV ads for prescription drugs is to sell products, not, as the drug industry would have people believe, to educate consumers.
[Created on 8/21/1997]

Statement Urging the American Medical Association (AMA) to Fire the People Responsible for the AMA’s Logo Appearing on Several Health Products. (HRG Publication #1425)
Statement by Sidney Wolfe, M.D.
[Created on 8/20/1997]

Letter to the Board of Trustees of the American Medical Association Protesting Their Endorsement of Sunbeam Medical Products. (HRG Publication #1424)
Letter by Sidney Wolfe, M.D.
[Created on 8/20/1997]

Press Release Challenging the Clinton Administration for Announcing New Testing Requirements for Children’s Medications but Allowing Off-Label Prescribing to Children. (HRG Publication #1423)
President Clinton’s announcement today to require drug makers to test whether their medicines are safe and effective for children does nothing to protect children from the widespread dangers of off-label prescriptions, said Public Citizen’s Health Research Group.
[Created on 8/13/1997]

Comments Supporting the Drug Enforcement Administration’s Proposed Placement of Butorphanol (Stadol and Stadol Nasal Spray) Into Schedule IV. (HRG Publication #1422)
Public Citizen strongly supports this action by the Drug Enforcement Agency (DEA) to regulate all forms of the potent opioid pain reliever butorphanol as a controlled substance. Butorphanol’s classification under the Controlled Substance Act (CSA) will finally inform doctors and consumers of this drug’s potential addicting properties.
[Created on 8/11/1997]

Letter to Senators Urging Them Not to Vote for S.830 Since It Would Roll Back Food and Drug Administration Protections. (HRG Publication #1421)
Sen. Jeffords’ bill S. 830, which seriously weakens the FDA’s ability to protect the American public from dangerous drugs and medical devices, will probably come before you for vote on the Senate floor this week. This legislation constitutes the first rollback of FDA protections in 91 years. There are no data nor documented reasons for this weakening of law and order for public health and safety.
[Created on 7/28/1997]

Letter to Senators Urging Them to Vote Against an Amendment to S.830 Which Would Make It Legal for Companies to Promote Drugs and Medical Devices for Unapproved Uses. (HRG Publication #1420)
The amendment, which would make it legal, for the first time, for companies to promote drugs and medical devices for unapproved uses, can most accurately be described as the killer fen-phen amendment, because it would have made legal the promotion of an even greater use of this already occurred without the manufacturers being able to promote this deadly combination.
[Created on 7/17/1997]

Letter to President Clinton Urging Him to Stop Sponsoring Unethical Biomedical Research on Mother-to-Infant HIV Transmission in Developing Countries. (HRG Publication #1419)
The United States government is sponsoring biomedical research on mother-to-infant HIV transmission in developing countries that could not be carried out in the U.S. Many people believe it is therefore unethical to conduct these studies in Africa, Asia, and the Caribbean, as is currently planned.
[Created on 6/11/1997]

Materials From Press Conference and Report of Physicians Disciplined for Sex-Related Offenses. (HRG Publication #1418)
Report by Christine Dehlendorf and Sidney Wolfe, M.D.
[Created on 6/4/1997]

Comments Before the Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee on Orlistat (Xenical) for the Treatment of Obesity. (HRG Publication #1417)
It is troubling that important information about orlistat has been kept secret, and the time allotted for public participation is in the hour before any presentations will reveal what is known about orlistat. Scheduling public comment later in the meeting, after presentation of what we believe are numerous studies involving large numbers of subjects(2), without the time to carefully evaluate these data is little better than keeping the data secret.
[Created on 5/14/1997]

Testimony Before the Subcommittee on Human Resources, Committee on Government Reform and Oversight, House of Representatives on HIV Vaccine Trials and a National Institute of Health-Funded Needle Exchange Program in Alaska. (HRG Publication #1416)
Our testimony today will address two subjects: HIV vaccine trials and a National Institutes of Health (NIH)-funded study of needle exchange programs in Alaska. While these two areas may seem disparate, there are several common themes that link them.
[Created on 5/8/1997]

Letter to the Department of HHS Concerning Their Funding of Unethical Trials Which Administer Placebos to HIV-Infected Pregnant Women Through NIH and the Centers for Disease Control. (HRG Publication #1415)
Unless you act now, as many as 1,002 newborn infants in Africa, Asia and the Caribbean will die from unnecessary HIV infections they will contract from their HIV-infected mothers in nine unethical research experiments funded by your Department through either the National Institutes of Health (NIH) or the Centers for Disease Control and Prevention (CDC).
[Created on 4/22/1997]

Testimony Before the Senate Labor and Human Resources Committee on the Food and Drug Administration Performance, Efficiency and Use of Resources. (HRG Publication #1414)
Among the items of enhanced enforcement authority we favor are: civil monetary penalties for any drug-related violation of the Food Drug and Cosmetic Act; broadening FDA inspection authority to include over-the-counter drugs; giving the FDA authority to require mandatory recalls and to be promptly notified of voluntary ones and to inspect drug-testing laboratories; and subpoena power for drug and other regulated industry records.
[Created on 4/11/1997]

Ranking of State Medical Boards’ Serious Disciplinary Actions in 1996. (HRG Publication #1413)
Report by Sidney Wolfe, M.D.
[Created on 3/25/1997]

Materials From Press Conference Announcing a New England Journal of Medicine Study Comparing Administrative and Personnel Costs in For-Profit and Nonprofit Hospitals (HRG Publication #1412)
Press Release by Steffie Woolhandler, M.D., M.P.H., David U. Himmelstein, M.D. and Sidney Wolfe, M.D.
[Created on 3/12/1997]

Letter to the Editor in the Washington Post Responding to Their Editorial Concerning the Effectiveness of Needle Exchange Programs. (HRG Publication #1411)
Letter by Sidney Wolfe, M.D.
[Created on 2/27/1997]

Letter to the Members of the Virginia General Assembly in Support of HB2218 Which Placed Restrictions on the Sale or Conversion of Nonprofit Hospitals. (HRG Publication #1410)
Letter by Sidney Wolfe, M.D. and Mary Gabay.
[Created on 1/22/1997]

1996

Letter to Harold Varmus Concerning HRG Response to the Panel Report on the Exchange Program (HRG Publication #1409)
Letter by Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 12/14/1996]

Letter to Harold Varmus, M.D., Director, NIH, Regarding Distortions and Misleading Comments Concerning HRG Request That He Withdraw the Money Grant for the Needle Exchange Program (HRG Publication #1408)
Letter by Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 12/12/1996]

Letter to Harold Varmus, M.D., Director of National Institutes of Health (NIH), Concerning Study Determining Availability of Syringes Through Pharmacies in Anchorage, Alaska for People Excluded From Using the Needle Exchange Program (HRG Publication #1407)
Letter by Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 11/18/1996]

HRG Comments on Draft Guideline One Testing for Carcinogenicity of Pharmaceuticals; Docket No. 96d-0235. (HRG Publication #1406)
Comments by Sidney Wolfe, M.D. and Larry Sasich, Pharm.D., M.P.H.
[Created on 11/1/1996]

Summary of Presentation by Sidney M. Wolfe, M.D., Before the Round Table on Hospital Reporting to the National Practitioner Data Bank (HRG Publication #1405)
Comments by Sidney Wolfe, M.D.
[Created on 10/29/1996]

Letter to Harold Varmus, M.D., Concerning Cancellation of NIH Funding of Research Project on Needle Exchange Programs. (HRG Publication #1404)
Letter by Peter Lurie, M.D., M.P.H. and Sidney Wolfe, M.D.
[Created on 10/17/1996]

Editorial by Sidney M. Wolfe in the 10/96 Vol. 11 Issue of the Journal of General Internal Medicine Entitled Why Do American Drug Companies Spend More than $12 Billion a Year Pushing Drugs? Is it Education or Promotion? (HRG Publication #1403A)
Enclosed is an article I have written which will appear in the Lancet this Saturday, September 7th. It discusses the demeaning way, inside the drug industry, that physicians are viewed, brainwashed and conquered.
[Created on 10/1/1996]

HRG Letter to David Kessler Regarding Lancet Ad Discussing Demeaning Ways That Physicians Are Viewed (HRG Publication #1403)
Enclosed is an article I have written which will appear in the Lancet this Saturday, September 7th. It discusses the demeaning way, inside the drug industry, that physicians are viewed, brainwashed and conquered. By identifying the hippocampus as the “prescription-writing center of the brain”, McAdam, advertising its marketing/mesmerizing skills to drug company marketing departments, offers to help sell drugs to doctors by brainwashing them into believing whatever drug is being advertised is superior.
[Created on 9/5/1996]

Letter to David A. Clarke, Chairman of DC Council, Concerning the Acquisition of George Washington University by Columbia/HCA Inc. (HRG Publication #1402)
Letter by Sidney Wolfe, M.D.
[Created on 8/29/1996]

HRG Comments on Direct-to-Consumer Prescription Drug Promotion Dated 5/14/96. (HRG Publication #1400)
We are aware of no valid scientific evidence that suggests DTC prescription drug advertising leads to better health outcomes for the public. On the contrary, based on the prevailing evidence presented above unregulated DTC advertising as currently allowed may induce needless economic hardship and perhaps physical harm to consumers.
[Created on 8/12/1996]

Petition to Require a Warning on All Fluoroquinolone Antibiotics (HRG Publication #1399)
Based on more than 130 reports of tendon inflammation (many involving rupture), most frequently involving the Achilles tendon, in persons using the widely-prescribed class of antibiotics known as fluoroquinolones, Public Citizen, representing consumers nationwide, hereby petitions the F.D.A. to add a warning about this serous problem to the label of all fluoroquinolone antibiotics marketed in the United States.
[Created on 8/1/1996]

Article From the Journal of National Institutes of Health (NIH) Research: Current FDA Reform Would Endanger Americans Appearing in 8/96 Issue Vol. 8 (HRG Publication #1401)
Article by Sidney Wolfe, M.D.
[Created on 8/1/1996]

From the L.A. Times Article “Save the Gold Standard…Proposed Bills Limiting FDA Review Would Allow Marketing of Second-Rate Drugs” by Sidney M. Wolfe (HRG Publication #1398)
[Created on 7/22/1996]

Comments on FDA Proposed Requirements for Accreditation Bodies of Mammography Facilities (HRG Publication #1396)
Comments by Laurel S. Mendelson, M.S.E. and Sidney Wolfe, M.D.
[Created on 7/2/1996]

HRG Comments on FDA’s Proposed Classification/Reclassification of Analyte Specific Reagents (ASR) (HRG Publication #1395)
Comments by Laurel S. Mendelson, M.S.E. and Sidney Wolfe, M.D.
[Created on 6/12/1996]

Comments on Guidance Documents; the Food and Drug Administration’s Development and Use (Docket No. 95p-0110) (HRG Publication #1393A)
Comments by Laurel S. Mendelson, M.S.E. and Sidney Wolfe, M.D.
[Created on 6/5/1996]

Letter to FDA Commissioner David Kessler Urging Him to Begin a Safety and Efficacy Review of All Pharmaceuticals Marketed in the US Prior to 1938 (Including Synthroid) (HRG Publication #1393)
In 1978, the last year for which data are available, the FDA estimated that 240 pre-1938 pharmaceuticals were being manufactured. Of these, only 45 had submitted safety and efficacy data in New Drug Applications, in most instances not for all dosage forms of the medication.
[Created on 5/29/1996]

Statement by Sidney M. Wolfe, M.D., Concerning Petition to Repeal DOD/FDA Regulation Allowing Waiver for Informed Consent for Experimental Drugs (HRG Publication #1392)
[Created on 5/7/1996]

Testimony of Sidney M. Wolfe, M.D., Before the House Subcommittee on Health and the Environment Hearings on H.R.S 3199-3201. (HRG Publication #1391)
[Created on 5/2/1996]

HRG Comments on Financial Disclosure by Clinical Investigators: Reopening of Comment Period; Docket No. 93n-0445 (HRG Publication #1390)
Public Citizen’s Health Research Group submitted comments on the Proposed Rule during the original comment period, supporting the concept of financial disclosure, but adding that disclosure alone is not enough to reduce the risk of bias in clinical research. We urged that researchers with any outcome-dependent interest be banned from owning an equity interest in a sponsor that exceeds a value of $25,000, and be banned from receiving significant payments of other sorts that exceed $5,000 per year.
[Created on 4/29/1996]

Letter to FDA Commissioner David Kessler Urging Him to Delay Approval of the Weight Control Drug Dexfenfluramine (HRG Publication #1389)
Public Citizen, representing 90,000 consumers, urges the FDA to delay approval for the weight control drug dexfenfluramine (Redux, Wyeth-Ayerst/American Home Products) until questions about its effectiveness, public health benefit and most importantly its safety are resolved.
[Created on 4/29/1996]

Statement of Sidney Wolfe, M.D., at FDA Hearing on Calcium Channel Blockers (HRG Publication #1385)
[Created on 1/25/1996]

Comments on Medical Device User Facility and Manufacturer Reporting, Certification and Registration Regulation, Docket No. 91n-0295 (HRG Publication #1384)
Comments by Laurel S. Mendelson, M.S.E. and Sidney M. Wolfe, M.D.
[Created on 1/10/1996]

 

1995

HRG Comments on Prescription Drug Product Labeling; Medical Guide Requirements (HRG Publication #1382)
The FDA’s medication guide proposal only perpetuates the misguided hope that there can be a voluntary private sector solution to the public’s drug information needs and will only deny access to vital information that the public needs to protect themselves from drug induced injury or death for at least four more years.
[Created on 12/20/1995]

Letter to Honorable Joe Barton, Subcommittee On Oversight and Investigations, Concerning Claims Made by Congressmen Cox about Health Research Group (HRG Publication #1381)
[Created on 12/5/1995]

Statement by Sidney M. Wolfe, M.D., Concerning Warner-Lambert Criminal Conviction and Poor Manufacturing Practices… Includes Dilantin Recalls (HRG Publication #1380)
In the first 11 months of 1995 alone, there were 20 recalls of Warner-Lambert products including 8 recalls for Dilantin and 3 recalls of Nitrostat. Since 1990, there have been a total of 64 recalls of Warner-Lambert products as listed in FDA recall reports.
[Created on 11/29/1995]

HRG Comments on S.1360 “The Medical Records Confidentiality Act of 1995” (HRG Publication #1379)
[Created on 11/28/1995]

HRG Citizen’s Petition to Require a Warning on All Calcium Channel Blocking Drugs (HRG Publication #1378)
This prescribing continues in the absence of evidence that these drugs [calcium channel blockers] prevent heart attack, heart failure, strokes or death and in the face of mounting evidence of their hazards. The FDA should also require patient package inserts for all calcium channel blockers.
[Created on 11/9/1995]

Letter to David Kessler, FDA Commissioner, Urging Him to Investigate Allergan, the Makers of Polytrim Ophthalmic Solution (HRG Publication #1376)
Less than a month after we wrote to you requesting that you investigate the pharmaceutical company Bayer for sponsoring a “Dear Doctor” letter concerning the widely-prescribed calcium channel blocker drug nifedipine (Adalat, Adalat CC) without disclosing that they had orchestrated and paid for the letter’s mailing, we are writing about a similar circumstance, this time involving Allergan, the makers of Polytrim ophthalmic solution.
[Created on 10/26/1995]

HRG Comments on “The Medicare Peer Review Organizations’ Role in Identifying and Responding to Poor Performers” (HRG Publication #1374)
[Created on 10/16/1995]

Testimony of Sidney M. Wolfe, M.D., Before the FDA Arthritis Advisory Committee on the Petition to Ban Piroxicam (Feldene) (HRG Publication #1373)
[Created on 10/11/1995]

1992

Criminalizing the Seriously Mentally Ill (HRG Publication #1277)
A nationwide survey of 1,391 local jails, which together hold 62 percent of all jail inmates, has revealed the unimaginable: 7.2 percent of jail inmates — more than 1 in every 14 — suffer from serious mental illness.
[Created on 9/9/1992]

Report: “Tobacco Money, Tobacco People Tobacco Policies. How Millions of Tobacco Dollars and Tobacco People in High Places Drive White House Pro-Tobacco Industry Policies” (HRG Publication #1275)
In a report, Public Citizen discussed how soft-money contributions to the two major political parties by the tobacco industry increased dramatically between 1988 and 1992. In 1988, the Democrats received only $38,000 from the tobacco industry; in the first six months of 1992 they received $731,000. In 1988, the Republicans received $448,000 from the tobacco industry; in the first six months of 1992 they received $1.34 million.
[Created on 8/26/1992]