» Drug, Devices, and Supplements

» Physician Accountability

» Consumer Product Safety

» Worker Safety

» Health Care Delivery

» Auto and Truck Safety

» Global Access to Medicines

» Infant Formula Marketing


Read our outrages

If you're not outraged,
you're not paying attention!

Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

FDA Helps Companies Exploit Patients With Alzheimer’s Disease

May 2012

Sidney M. Wolfe, M.D.

For the second time in less than two years, the Food and Drug Administration (FDA), at the behest of companies seeking to exploit the large market for Alzheimer’s disease, has approved a product with little proven benefit and documented risks.

The first of these two unwarranted FDA approvals of Alzheimer’s disease products occurred in July 2010, when the FDA approved a new, high-dose version of Pfizer/Eisai’s top-selling but patent-expired Alzheimer’s drug Aricept (Aricept 23). The agency approved the drug over the objections of most of its scientists, who noted that the drug did not improve overall functioning but caused considerably more side effects than an older, lower-dose version of the drug.

The most recent example is a dye, Amyvid, which is injected into patients with possible Alzheimer’s disease and, on the basis of a subsequent brain scan, is used to detect amyloid plaque in the brains of such patients. A brain scan finding involving amyloid plaque is related to Alzheimer’s disease.

After the FDA recently approved this dye, despite strong opposition from several experts in brain imaging and from Public Citizen, the manufacturer, Eli Lilly, hemmed and hawed in a statement about some of the test’s limitations, while cheering its approval.

The ifs, ands and buts in the Lilly press release failed to obscure the fact that this is an inaccurate test, subject to serious physician interpretation differences. The test has been shown to detect amyloid plaque in some patients who do not have Alzheimer’s disease and to fail to detect the plaque in some patients who turn out to have the disease. Clearly a financial boon for Lilly, the approval sends another blow to Alzheimer’s patients and those who love them.

Approving a diagnostic test that can falsely suggest that someone has Alzheimer’s disease can obviously result in considerable anxiety for patients, their families and friends. Considering this decision along with the dangerous FDA decision to approve Aricept 23, the agency’s and the drug industry’s priorities toward the well-being of Alzheimer’s patients seem to be taking a backseat to the well-being of companies such as Lilly and Pfizer/Eisai.

Copyright © 2016 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.

Public Citizen, Inc. and Public Citizen Foundation


Together, two separate corporate entities called Public Citizen, Inc. and Public Citizen Foundation, Inc., form Public Citizen. Both entities are part of the same overall organization, and this Web site refers to the two organizations collectively as Public Citizen.

Although the work of the two components overlaps, some activities are done by one component and not the other. The primary distinction is with respect to lobbying activity. Public Citizen, Inc., an IRS § 501(c)(4) entity, lobbies Congress to advance Public Citizen’s mission of protecting public health and safety, advancing government transparency, and urging corporate accountability. Public Citizen Foundation, however, is an IRS § 501(c)(3) organization. Accordingly, its ability to engage in lobbying is limited by federal law, but it may receive donations that are tax-deductible by the contributor. Public Citizen Inc. does most of the lobbying activity discussed on the Public Citizen Web site. Public Citizen Foundation performs most of the litigation and education activities discussed on the Web site.

You may make a contribution to Public Citizen, Inc., Public Citizen Foundation, or both. Contributions to both organizations are used to support our public interest work. However, each Public Citizen component will use only the funds contributed directly to it to carry out the activities it conducts as part of Public Citizen’s mission. Only gifts to the Foundation are tax-deductible. Individuals who want to join Public Citizen should make a contribution to Public Citizen, Inc., which will not be tax deductible.


To become a member of Public Citizen, click here.
To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.