A recommendation by the American Medical Association's Council on Ethical and Judicial Affairs to eliminate pharmaceutical industry funding from medical education was not approved by the AMA's Reference Committee, but could return in another form next year. After hearing all the testimony on June 15 at the AMA's annual House of Delegates meeting, AMA's Reference Committee recommended that the report, “Industry Support of Professional Education in Medicine,” be referred back to. The next day, June 16, the AMA's House of Delegates voted in favor of the recommendation to refer.
During the Reference Committee hearing, speakers representing more than 40 organizations, including the Alliance for Continuing Medical Education, North American Association of Medical Education and Communication Cos., and the Council of Medical Specialty Societies, spoke out against CEJA's recommendation, while just a handful spoke in support of it. CEJA's proposal called for the elimination of industry funding from medical education except in cases where technical training in the use of a new technique or device is required. The report argues that industry funding can threaten the integrity of professional education and that the mechanisms in place to manage potential conflicts are not sufficient to address those concerns.
“I think everybody heard some real good input from the many stakeholders who were present, and I hope that will be taken into account in the next version of this very important issue,” says CEJA chairman Mark Levine, MD, FACP, associate professor of medicine, University of Colorado Denver, and co-author of the report. “The fact that the House [of Delegates] referred it back accomplished, if nothing else, that this is a significant issue that does need to be addressed,” adds Levine, whose term on the council has now expired.
The decision to refer was not a surprise to many, given the heavy outcry and volume of testimony opposed to the recommendation. While many praised the intention of the report — to provide ethical guidance for physicians — they took exception to the conclusions drawn. “To just say that any and all commercial support for professional education is unethical was unpalatable to quite a few groups,” says Bruce Bellande, PhD, FACME, president, CME Enterprise, Indianapolis.
A “fatal flaw” in the report, says Norman B. Kahn Jr., MD, executive vice president, CMSS, Lake Bluff, Ill., was that it failed to distinguish between certified CME, put on by accredited providers that meet Accreditation Council for CME standards, and promotional education, put on by industry to promote products. “There are firewalls and safeguards to prevent the insertion of bias in certified CME, but not in promotional education,” says Kahn. “We were very concerned that if commercial support of certified CME was prohibited, then all of the money would go into promotional education.”
Many other speakers raised the same concern, including George Mejicano, MD, associate dean for continuing professional development at the University of Wisconsin School of Medicine and Public Health, Madison, who spoke on behalf of the Alliance for CME. Mejicano also voiced the Alliance's opposition to the clause that would allow industry support to train physicians on new devices. “Who would decide when a device is no longer new?” asks Mejicano. New is a relative term; the same device that is new for some people might be well-known to others, he says.
In its written statement, the Alliance also said that “there is no existing evidence that supports the far-reaching premise that the elimination of commercial support for certified educational activities would eradicate bias in CME.”
Opposing voices faulted the report for not recognizing the new requirements put in place by the Accreditation Council for CME in recent years to prevent bias. In addition to updating its Standards for Commercial Support in 2004 and adding new accreditation criteria in 2006, theis now not only looking at tighter enforcement of the rules (in response to a call by the U.S. Senate Finance Committee for more oversight), it is also re-examining the influence of commercial support on CME. (See “Border Control,” page 19.)
Others said the report didn't cite enough current evidence and research. ”The data largely predate existing conflict-of-interest management programs and do not provide a scientific basis for the subsequent conclusions,” reads the statement issued by the National Task Force on CME Provider/Industry Collaboration.
Not a Dead Issue
Opponents of the proposal should not be complacent, said Mejicano. “This is not a defeat. People think it was a defeat — it isn't,” says Mejicano. “This is a postponement. Is it flawed, yes, I think it is flawed, but do not consider this a dead issue.” Unlike other AMA councils, CEJA's recommendations cannot be altered because of its status within the association. Had there been an opportunity to amend some of the findings before the vote, there might have been a very different outcome, adds Mejicano. Nonetheless, he expects CEJA to come back next year with a report that draws clear distinctions between promotional and certified education.
Levine concurs that the next iteration of CEJA's report should address that issue. “What is the borderline between marketing and education?” he asks. “There are some things that approach elements of both. Is it necessary or appropriate to draw a clear line that separates them or to define a gray area that mixes them?” While he is no longer serving on CEJA, he plans to contribute to the dialogue going forward.
Mejicano also speculates that CEJA may come back with a recommendation that doesn't call for eliminating commercial support from certified CME but perhaps calls for more diversified funding of CME.
David Davis, MD, vice president, continuing healthcare education and improvement, Association of American Medical Colleges, says that's an important point to make. From his perspective, the issue is less about the amount of commercial support of CME and more about the lack of funding support from other places. “We have become dependent on an outside source,” he says. CME should be viewed as a collective responsibility, which means that a more diverse group of organizations — like municipalities, institutions, medical centers, payers, insurers, physicians, foundations — should be engaged to help fund CME and improve patient care. Commercially supported CME tends to skew towards therapeutically oriented education — medications and procedures, etc. — and less toward risk-reduction education, he says, such as changing nutrition, exercise, and dealing with child and spousal abuse.
For a copy of the report, visit www.ama-assn.org.
Susan P. Tyler, MEd, CMP, has joined the University of Cincinnati Medical School as director of CME. She previously served as manager, CME accreditation department, American Academy of Family Physicians, Leawood, Kan.
Nancy H. Nielsen, MD, PhD, an internist based in Buffalo, N.Y., was inaugurated as the 163rd president of the American Medical Association in June. She is only the second woman to hold this office.
The Josiah Macy Jr. Foundation has released its full report, “Continuing Education in the Health Professions: Improving Healthcare through Lifelong Learning,” which says that the CME enterprise needs a major overhaul, and recommends banning commercial support. Visit www.josiahmacyfoundation.org.
The American Nurses Credentialing Center, the Accreditation Council for CME, and the Accreditation Council for Pharmacy Education sent a joint response to the Macy Foundation in June, taking exception to almost all of the report's conclusions. For a copy of the letter, visit accme.org.
In June, the U.S. Senate Special Committee on Aging sent a letter to the Accreditation Council for CME seeking information about its accreditation process. The committee is concerned that pharmaceutical companies use CME as a marketing tool. For more information, visit accme.org.
More than 23 percent of attendees at U.S.-based www.hcea.org.come from outside the country, according to a recent research report conducted by the Healthcare Convention and Exhibitors Association. For more, visit
92 percent of the 268 physicians surveyed by Boston-based CME provider Pri-Med said they disagreed with CEJA's recommendation to end commercial support. Respondents said that the elimination of commercial support would make CME more expensive, decrease its quality, and lead to fewer activities, which would hurt patient care.
78 percent of Society for Academic CME members surveyed said the CEJA report should be referred back to CEJA, while 57 percent said it didn't paint an accurate picture of the CME environment. Fifty-six SACME members responded.