The fifth time was the charm for the American Medical Association’s Council on Ethical and Judicial Affairs 1-A-11 report, "Financial Relationships with Industry in Continuing Medical Education,” which was passed by the AMA House of Delegates in late June.
While the most recent version still frowns on the commercial support of CME, its stance was softened from that of earlier versions that had called for the elimination of industry funding from medical education. The report now recommends “When possible, CME should be provided without such support or the participation of individuals who have financial interests in the educational subject matter.”
It also concedes that there are situations where commercial support or participation of those who have a financial interest in the topic is necessary; in those cases, CEJA recommends that providers do their best to ensure that the activity remains independent and unbiased. (Download the full report here.)
Dealing with Rejection
The House of Delegates sent CEJA’s previous proposals back to committee in 2008, twice in 2009, and last year. Most recently, the 2010 version was rejected due to concerns that the potential for commercial support to bias CME was already being addressed by the Accreditation Council for CME and Council of Medical Specialty Societies policies, and because there was no compelling evidence that commercial support in fact does cause CME activities to become biased.
According to George Mejicano, MD, president of the Alliance for CME, these issues remain in the approved version. “Advocating for its members and the profession, the Alliance testified against passage because the proposed CEJA recommendations are not supported by empirical evidence published in the peer-reviewed literature,” he said in a statement. Further, he said, “The Alliance believes that the current processes used by accredited providers of continuing education in the health professions safeguard the delivery of unbiased education that promotes evidence-based medicine and improves patient safety.” Other organizations that opposed the recommendations included the American Association of Clinical Endocrinologists and the American College of Surgeons.
Nevertheless, a preliminary AMA report on the HOD’s latest actions said that while testimony regarding the 1-A-11 report was divided, “Much testimony affirmed that this iteration of the report contained marked improvements over the prior version and supported the changes that CEJA made in response to concerns previously heard.” Those who supported the recommendations include the American Association of Family Physicians, and the American College of Physicians.
AMA board member Carl Sirio, MD, said in a statement, “The new AMA policy helps protect the independence and integrity of physician education and ensures physicians avoid relationships that may undermine public trust. Crafting ethical guidance to accomplish this has been a long process, but we are confident that the policy … helps to preserve the independence and integrity of continuing medical education.”
ACCME’s chief executive Murray Kopelow, MD, said that the AMA’s decision aligns with longstanding ACCME principles and policies. Kopelow quoted from documents ACCME released in 2004 that said, “Commercial support has the potential to introduce commercial bias that threatens the integrity of the CME enterprise. When individuals have financial relationships with commercial interests and are in a position to control the content of CME, there is also the potential for commercial bias. The ACCME believes that CME must be free of the control of commercial interests. The ACCME believes that this independence from commercial interests will help ensure that CME is free of commercial bias.” He added, “We believed this then and we believe it now. Any organization that restates those principles certainly has our support.”
Changes in the Wind?
According to Daniel Carlat, MD, a psychiatrist in private practice in Newburyport, Mass., and associate clinical professor of psychiatry at Tufts Medical School, the CEJA recommendations should cause some changes in the CME enterprise.
As he said on The Carlat Psychiatry Blog, “The delegates voted to approve a report of the AMA ethics committee that calls for a near elimination of industry support for CME” because of the recommendation that providers should try to keep activities commercial-support–free. “CEJA finally was able to make the statement that industry financing of CME is in some sense inappropriate or unethical or wrong,” he added in an interview. “They were trying to specify the circumstances where it would be appropriate to accept commercial support, which were few.”
Among the circumstances in which commercial support would be ethical, according to the CEJA report, were “activities that require cadavers or high-cost, sophisticated equipment to train physicians in new procedures or the use of new technologies. Similarly, in the earliest stage of adoption of a new medical device, technique, or technology the only individuals truly qualified to train physicians in its use are often those who developed the innovation.” It also would be ethical in rural areas where access to faculty with no financial ties to potential commercial supporters would be difficult to retain.
“I don’t know who could disagree with companies funding courses in which very expensive interventional cardiology or orthopedic devices need demonstration,” said Carlat. “It’s fine with me for industry to pay for that kind of CME. But certainly in most of medicine, CME courses are about teaching doctors how to prescribe medications, so it doesn’t seem that most of these courses would fit the criteria of appropriateness as set out by the CEJA report.”
He sees it as a change in the cultural zeitgeist of CME, one that will end up further diminishing the already declining amount of commercial support made available to providers over the next few years. And one that Carlat believes the Accreditation Council for CME will have to address by revising its Standards for Commercial Support to say that in many situations, it is considered inappropriate for commercial entities to support CME at all.
Kopelow stressed that the ACCME had repeatedly assessed whether or not accredited CME should be commercially supported, citing a call for comment in 2008 that proposed restricting commercial support to CME that met certain conditions. “Even that was rejected as unnecessary because of the Standards for Commercial Support,” he said. In fact, now that the White House and the Food and Drug Administration want accredited CME to address accidental deaths from substance abuse through the Risk Evaluation and Mitigation Strategy piece of the FDA Amendments Act of 2007, commonly referred to as REMS, “those who say we should get rid of commercial support of CME would be denying physicians access to education that’s going to be specifically designed to deal with this public health crisis. The interest of the public should be first.”
While he maintained that the recommendations would be subject for discussion among the CME community in general and the ACCME board of directors specifically, Kopelow said it remains to be seen if the recommendations would result in any changes in the way accredited providers do business. While many of the recommendations mirror the requirements of the Accreditation Council for CME’s Standards for Commercial Support, the CEJA report also maintains that physicians who attend commercially supported CME activities should be able to expect transparency around financial relationships, including the source and nature of the activity’s commercial support, disclosures from interested parties, and what’s being done to mitigate any potential for influence.
The ACCME’ SCS does require providers to identify and resolve conflicts of interest, but it does not require making those processes public. (These processes are reviewed by the ACCME during the reaccreditation process.) The ACCME requires providers to disclose to learners the source of commercial support, as well as the relevant financial relationships of anyone in control of content, including the name of the commercial interest and the nature of the relationship; however it does not require providers to disclose the "magnitude" of the individual’s financial interest. He expects the ACCME will “look at those two recommendations to see if they should have any impact on how we implement the Standards.” Before implementing any modifications, the ACCME would issue a call for comment, in accordance with its rule-making policy.
As to the decline in commercial support that Carlat foresees resulting from the CEJA report, Kopelow maintains that the decline in commercial support over the past several years is more a natural adjustment to “an incredible amount of growth that isn’t entirely explicable” in the past that is now leveling out, and that further diminishment will likely be more due to corporate issues than a reaction to the CEJA report.
Thomas Sullivan, president and founder of medical education company Rockpointe Corp. and an outspoken blogger on issues related to CME policy, doesn’t seem too worried about potential ramifications. He read this version as representing “a much more reasoned approach to commercial support, [one that acknowledges] the reality that CME often cannot take place without help from outside resources including industry.” He added that it’s not likely the report’s adoption will lead to any major changes in current CME practices, other than “perhaps a greater emphasis by physicians on disclosure and more thought by providers on seeking additional sources of CME funding. We may even see other stakeholders, including health systems, insurance, and governments, seeing this as a wake-up call and opportunity to support CME that improves patient care.”
Kopelow believes that REMS, should it become a standard operating procedure, could be the real game-changer. If that happens, and CME can deliver education whose content is overseen by the FDA, is based on practice-based needs, and can demonstrate change in physician competence or performance, “that juxtaposition of patient needs and accredited CME and commercial support will be one that we’ve never seen before,” he said. “If a large proportion of pharmaceutical and device supported education is derived from REMS, that would lead to a whole new era—not started by our Standards for Commercial Support or by CEJA’s guidelines, but consonant with them.”
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