An article last year in the New England Journal of Medicine (NEJM) focused on “The agenda for continuing medical education — limiting industry’s influence.” The article, written by Lewis Morris, J.D., and Julie K. Taitsman, M.D., J.D., of the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS), created a large discussion about the proper role of industry in continuing medical education (CME). As a result, comments were sent to NEJM, and are summarized below, along with a summary of the author’s response.
Lois Colburn, B.E.S. and Todd Dorman, M.D., representing the Society for Academic CME, noted that the article “did little to advance the informed discussion about the role of commercial support in CME.” They specifically asserted that the article was weak because “it relied on outdated sources, inappropriate references, and anecdotal evidence, making points (e.g., directed payment, content) that are irrelevant to CME practice in 2009.”
Moreover, they noted that while “commercial support for CME did indeed increase between 1998 and 2007, this increase paralleled that for total funding and thus was part of an overall increase in health care funding by industry, not an effort focused on CME.” They also pointed out that “data from the Accreditation Council for Continuing Medical Education (ACCME) showed that commercial support declined nearly 15% between 2007 and 2008, and that after implementation of the ACCME’s revised Standards for Commercial Support, the rate of increase in commercial support dramatically declined.”
Accordingly Colburn and Dorman assert that the “Standards for Commercial Support, coupled with the OIG Compliance Program Guidance, have set clear boundaries between education and marketing.” Since these new regulations and rules have been put in place, “what is needed now is solid research on the effects of these regulatory changes,” not a restriction or prohibition of industry funded CME.
Clearly then, with these changes and ongoing efforts of industry, academia, and CME providers, articles such as Morris and Taitsman, which “continue to rehash old rhetoric only does a disservice to both accredited CME providers and the medical profession.”
Rafael Fonseca, M.D., of the Mayo Clinic, as well as a member of the Association of Clinical Researchers and Educators (ACRE), asserted that the article proposes that medicine should “eschew commercial support for CME.” Dr. Fonseca, who serves as a lecturer at CME events noted that Morris and Taitsman “underplay the value of industry-supported CME” because the article “mainly portrays alleged risks.”
Such a practice, which is common for critics of industry funded CME, ignores the fact that “audience attendance at commercial CME–sponsored events, is voluntary and uncompensated.” In addition, CME events “usually occur in the evening or on weekends — in time away from a busy practice or family.” Interestingly, because physicians have other alternatives for CME certification (e.g., online, journal-associated), it should come as no surprise that those who attend CME-sponsored events “must find value in these sessions beyond that of the accompanying meals.”
Dr. Fonseca also reminds the authors of some important evidence to support the continued use of industry sponsored CME, such as the fact that “several physician groups have already started to reject the notion that industry sponsorship of CME should end.” Additionally, research from the IOM “could not find objective evidence of harm” from industry supported CME. This kind of evidence was also portrayed in a “recent peer-reviewed study by Ellison et al., funded by a CME company, which showed that the vast majority of physicians in the audience at such events do not perceive undue influence.”
Martin Mendelson, M.D., Ph.D., acknowledged that Morris and Taitsman’s article “speculates that hospitals and physicians may be unwilling to supply the approximately $1,500 per U.S. physician currently expended annually on putative CME by the pharmaceutical and device industry.” As a professor at the University of Washington School of Public Health in Seattle, he asserted that such a claim “may well be wrong.” In fact, he noted that $1,500 “would be an acceptable” amount for those in specialties that are less well paid. Consequently, he proposed that funds for CME should be obtained by states through tax-deductible “registrations,” in which periodic fees are remitted to a central funding source. Such an idea Dr. Mendelson believes, “would be a small price to pay for reliable information and public credibility.”
The Authors Reply
In response to these comments, Morris and Taitsman note how each author argued that industry funding poses little risk to CME integrity. With regards to Dr. Fonseca, they asserted that the study he cited “did not rebut their position that “industry funding can influence CME content.” This idea is too broad and prohibitive. Regardless, they believe that the study Dr. Fonseca cited actually demonstrates OIG’s “concern about the subtle nature of the problem.” They believe that there are other ways to measure industry influences besides simply asking physicians whether or not they detected bias. They do not list however what those ways are. What could possibly be a better method?
Instead, they point to a survey that they felt portrayed the difficult question of “physicians’ ability to accurately predict the effect of industry influence.” Despite this survey, the fact that industry influence or bias in CME may be difficult to detect does not correlate with “limiting industry.” That’s like saying because all the Borders and books stores on the street have the potential to sell offensive books with undetectable bias messages (without defining offensive), we should limit where they are allowed to do business.
Morris and Taitsman need to offer a real solution to address the “potential” for bias or “difficulty” detecting it, not just eliminating a valuable source of education for physicians, which ultimately helps patients. Fortunately, they agree with the idea “that more comprehensive research would help to quantify the extent to which industry funding influences CME content.”
Although they agree with the need for more research, they claim that CME observers need “substantial expertise in the subject matter,” including the relative merits of all available treatments and the treatment options omitted from the agenda, to be able to detect bias. To suggest that highly trained and experienced professionals are not already experts or able to detect such bias is problematic, and questions the very nature of medical education.
Morris and Taitsman worry about “pernicious” industry influence but are forced to acknowledge that in the most common forums, evidence of bias is so subtle as to be virtually undetectable. At what point is undetectable tantamount to unimportant? In manufacturing, there are established tolerances within a specification as part of quality control procedure. If the material and device are within the specification, that product is deemed safe. I’m afraid Morris and Taitsman, by their own admission, concede that the they are hard pressed to find a problem.
CME programs, almost all of which present a balanced discussion of treatment options, allow experts to carefully consider what they are being taught. It is easy for them to realize the program they are at is funded by industry, if so, because this information is advertised, published, and disclosed. As a result, the idea that “industry funding may create a CME agenda skewed to favor topics related to more expensive pharmacotherapies backed by generous marketing and education budgets” is unnecessary, mainly because doctors know what they are getting into. Again, they voluntarily attended, are not getting paid, and are taking valuable time out of their schedules to attend CME events when they have other options.
Ultimately, the comments from above clearly demonstrate that “the value of CME should be gauged on content, not provenance, because limiting CME (a sure consequence of no industry funding) carries the real risk of limiting the transmission of knowledge and of being deleterious to patients.” It is important that OIG stick by its words and continue to research this topic before prohibiting a resource that will eventually leave doctors without knowledge of new treatments and ways to make people healthier.
John’s Hopkins CME Blog: NEJM Letter to Authors