February 23, 2009

Letter Supporting Ban on Commercial Support of Continuing Medical Education

Regina M. Benjamin, M.D., M.B.A.
Chair, Council on Ethical and Judicial Affairs
Claudette C. Dalton, M.D.
Chair, Council on Medical Education
American Medical Association
515 N. State St.
Chicago, IL 60654

Dear Drs. Benjamin and Dalton:

We would like to thank the American Medical Association (AMA) for inviting us to submit comments to the AMA’s Council on Ethical and Judicial Affairs and its Council on Medical Education regarding commercial support of continuing medical educations (CME).  

We strongly support a ban on all commercial support of CME because the consequences of any corrupting influence of commercial support on CME are so significant.  Physicians expect the science presented in CME to be high-quality; thus any influence that potentially compromises this standard should be removed if possible. Given the existence of a viable alternative (physician-supported CME), there is no need to continue commercial support for CME.   In the absence of a ban, inevitably there will be tension between the educational mission of CME and the financial objectives of commercial companies. No set of voluntary half-measures can assure that the educational objectives will take precedence.

We will provide general comments that address the three questions you posed to us rather than addressing each question specifically.

The AMA was an early advocate for CME and has since been central in shaping it.  Today, the AMA still plays an important role through the Physician Recognition Award (PRA), the AMA PRA credit system, and the direct provision of CME credit. As the voice of organized medicine, the AMA is well positioned to lead a reform effort to eliminate commercial support of CME.

It is important to recall that CME was born out of the desire to ensure that physicians remained abreast of advances in medical science.   This was and remains the primary purpose of CME.  However, in the 1970’s, shortly after states began adopting CME requirements as a condition for medical licensure, commercial interests (primarily pharmaceutical companies) seized upon physicians’ desire to keep the cost of CME as low as possible and inserted themselves into the CME process.[1]   By assuming the role of financier, commercial interests were able to influence the substance of CME and, as we will show below, increase the sales of their products. With 48% of all funding for CME (excluding advertising and exhibit income) now provided by commercial interests,[2] it has become difficult for many to even imagine CME without commercial support.

Yet CME’s reliance on commercial support was neither inevitable, nor is it irreversible.  Indeed, to a limited extent, it is currently being reversed.  With increasing scrutiny from the medical profession,[3],[4],[5] the government,[6] and the public,[7],[8],[9] a movement is developing that would free CME from commercial support.[10],[11] The ACCME recently considered a proposal that would eliminate commercial support of CME.[12] Seven academic medical centers (Stanford University, University of California at Davis, University of Colorado, University of Kansas at Kansas City, University of Missouri at Kansas City, University of Pittsburgh, and University of Massachusetts) have restricted direct commercial support of CME, but allow companies to contribute to a central pool that supports CME.[13],[14] Memorial Sloan Kettering Cancer Center banned any commercial support for CME.[15]  On the sponsor’s end, Pfizer, the world’s largest pharmaceutical company, announced last year that it would no longer support CME offered by medical education and communication companies (MECCs).[16]   Zimmer, a major manufacturer of orthopedic medical devices, announced it would use only independent, third parties to support CME.[17]   Others are addressing the problem of commercially funded CME more directly. The Attorney General Consumer and Prescriber Education Grant Program, an online CME curriculum specifically addressing pharmaceutical company marketing practices, is funded through the settlement of a lawsuit for off-label promotion of Neurontin.[18]

By some measures, CME’s dependence on commercial support is actually decreasing. Despite a quadrupling of commercial support for CME over the past ten years, in 2007 the percentage of CME income provided by commercial interests actually decreased to close to 2002 levels (47%).[19]

Eliminating commercial support for CME is critical because there is significant evidence that it affects the integrity of CME. Perhaps the most profound effect of sponsorship is that it influences the choice of topics to be addressed – typically those for which a commercially available product (usually a drug) exists.[20],[21]  This skews CME away from topics of public health significance, but which lack a patent-protected therapy. Compared to conferences with no direct commercial support, commercially supported CME symposia present a narrower range of topics and tend to focus on medical conditions for which there are new therapeutic products.[20] Commercially-driven CME also ensures that dietary and behavioral interventions are not given due consideration. To fully serve their patients, clinicians need a fair and balanced perspective, not one tainted by industry’s agenda.

Moreover, commercial support has been associated with sponsors’ primary objective: increases in prescribing. Following three different commercially supported CME lectures about antihypertensive drugs, the rate of new prescriptions increased after two lectures and decreased after one.   In each case, the sponsor’s share of prescriptions in that class of drugs rose.[22]

In our own research, we were able to demonstrate that commercial booths at an annual professional association meeting, a major source of CME for the attendees, frequently violated the professional association’s own voluntary codes of conduct.  In unprompted discussions with research assistants posing as conference attendees, drug company representatives at four of 24 booths (17%) even engaged in illegal off-label promotion of drugs.[23]

One relatively new development in CME merits particular mention.  MECCs are primarily for-profit firms that organize CME conferences and lectures.[24] These companies have grown enormously in the last ten years[19],[25] and over seventy percent of their 2007 income originated from commercial sources.[2] MECCs are thus not objective providers of educational information, but rather marketing firms with an obvious interest in promoting sales of their sponsors’ products.[5], [26]   We remain concerned that, even if a physician presenting at a CME event discloses his or her relationship to a MECC, audience members would not know which drug or device manufacturers had financial relationships with the MECC.

The basic options open to the AMA are either disclosure of conflicts or policy restrictions.  The impact of disclosure is limited.  Used by itself, disclosure simply transfers to the consumer of the CME activity the responsibility for interpreting the often-complex details of the conflict of interest.[26] Policy restrictions may be more- or less restrictive.  Less-restrictive forms attempt to maintain a role for commercial support but may fail because, just as only partially blocking a river flowing downhill will cause the water to carve a new path, they simply lead to more creative methods of influencing physicians, as demonstrated by the proliferation of MECCs.[3],[19],[25] In contrast, policy restrictions that ban commercial support entirely (the option we favor in this case) have the twin virtues of simplicity and effectiveness.

Eliminating commercial support of CME could have some downsides, the most obvious of which is losing the single largest funding source of CME.   However, because CME would continue to be a requirement for physicians to maintain their state licensure, the demand for CME would continue essentially unabated.  Commercial support has shielded physicians from the true costs of CME.  Shifting the burden of funding toward physicians would attenuate the effect of lost revenue. 

Fortunately, the impact of eliminating commercial support of CME may not be as drastic as some imagine. The CME enterprise does not operate at the margins of profitability; whereas in 1998 CME in the U.S. was operating at a 5% profit margin, only 10 years later (2007) the profit margin had skyrocketed to 23%.[19] Thus, because a large percentage of money spent on CME does not actually go toward physician education, not all the income reduction from the elimination of commercial support need be recouped from physicians if the industry accepted more modest profit margins. 

Ultimately, there is an irreconcilable difference between the scientific purposes of CME and industry’s efforts to promote its products.  It is naïve to believe that the latter can be accommodated while leaving the former untainted. As long as industry has a seat at the table, the tug-of-war to control the agenda of CME will continue. Eliminating commercial support would reestablish the profession as the sole arbiter of CME content, improve the quality of CME, and reaffirm the primary mission of CME – promoting life-long learning and enhancing physician competence. It might also serve as an impetus to move away from expensive, lecture-dominated destination meetings and toward cheaper, more content-intensive forms of CME, such as mail-in and online courses. For these reasons, we support ending commercial support of CME.

Sincerely,

Jonas Hines
Research Associate

Peter Lurie, M.D., M.P.H.
Deputy Director
Health Research Group at Public Citizen

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[1] Podolsky SH, Greene JA. A historical perspective of pharmaceutical promotion and physician education. Journal of the American Medical Association. 2008;300(7):831-3.