Accreditation Council for Continuing Medical Education
515 N. State Street, Suite 1801
Chicago, IL 60654
To whom it may concern:
We would like to thank the Accreditation Council for Continuing Medical Education (ACCME) for the opportunity to comment on its Proposed Policy to Support Independence in Accredited CME (Continuing Medical Education). In particular, we would like to comment on the proposal that “the commercial support of continuing medical education end.” We strongly support such a proposal because the consequences of the corrupting influence of commercial support on CME are so significant. An outright ban, rather than a compromise that will allow deviations from the objectivity of CME, is therefore justified. Inevitably, in the absence of a ban, there will be conflicts 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.
In considering this proposal, 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. By assuming the role of financier, commercial interests were able to influence the substance of CME and, presumably, increase the sales of their products. With 48% of all funding for CME (excluding advertising and exhibit income) now provided by commercial interests, 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 both the public,, and the medical profession,,, a trend toward developing CME that is free from commercial support is gaining momentum., Six academic medical centers (Stanford University, University of California at Davis, University of Colorado, University of Kansas at Kansas City, University of Pittsburgh, University of Massachusetts) have banned direct commercial support of CME, but allow companies to contribute to a central pool that supports CME., Memorial Sloan Kettering Cancer Center bans any commercial support for CME. On the sponsor end, citing growing concern over conflict of interest, Pfizer, the world’s largest pharmaceutical company, announced this year that it would no longer directly support CME offered by medical education and communication companies (MECCs); Zimmer, a major manufacturer of orthopedic medical devices, announced it would use only independent, third parties to support CME. With support from the settlement of a lawsuit for off-label promotion of Neurontin, the Attorney General Consumer and Prescriber Education Grant Program funded the development of an online CME curriculum specifically addressing pharmaceutical company marketing practices.
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%).
Moreover, there is significant evidence that commercial support 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.,This skews CME away from topics of great 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. It also ensures that dietary and behavioral interventions receive short shrift.
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 codes of conduct. In brief, unprompted discussions with research assistants, drug company representatives at 4 of 24 booths (17%) engaged in illegal off-label promotion of drugs.
Finally, commercial support has been associated with the primary objective pursued by sponsors: 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.
One relatively new development in CME merits particular mention. MECCs are for-profit firms that organize CME conferences and lectures, often on behalf of commercial sponsors. These companies have grown enormously in the last ten years, and over seventy percent of their 2007 income originated from commercial sources. MECCs are thus not objective providers of educational information, but rather marketing firms with an obvious interest in promoting sales of their sponsors’ products.,
In principle, several approaches to controlling conflicts of interest in CME could be envisioned: legal restrictions, disclosure, and policy restrictions. The most far-reaching (and the one we favor), legal restrictions would ban commercial support of CME. The advantage of legal restrictions is that they are straightforward and very effective, eliminating the conflict of interest entirely. However, the trend in the CME field has instead been toward not rocking the income boat, relying primarily on enhanced disclosure policies with voluntary policy restrictions for the most egregious forms of conflict. But, in effect, disclosure transfers to the consumer of the CME activity the responsibility for interpreting the often complex conflict of interest. Policy restrictions attempt to establish specific (typically unenforceable) firewalls while still maintaining a role for commercial support. However, just as only partially blocking a river flowing downhill will cause the water to carve a new path, policy restrictions simply lead to more creative methods of influencing physicians, as demonstrated by the explosive growth of MECCs.,,
Eliminating commercial support of CME could have the downside of losing the single largest funding source of CME. However, since CME would continue to be a requirement for physicians to maintain their state licensure (and thus board certification), the demand for CME would be essentially unabated. Commercial support has shielded physicians from the true cost of CME. Shifting the burden of funding toward physicians (not exactly a group occupying the lower rungs of the earning ladder) would attenuate the effect of lost revenue.
It is also worth noting that CME is not exactly an enterprise operating 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%. This leaves plenty of profit that could be recycled to offset the loss of commercial support. Indeed, an ACCME policy eliminating commercial support of CME is well within reach.
Eliminating commercial support and with it the conflicts of interest that are currently rife would 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.
Peter Lurie, M.D., M.P.H.
Health Research Group at Public Citizen
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