AAMC Calls for Tougher CME Rule Rules, Gift Ban
The Association of American Medical Colleges Task Force on Industry Funding of Medical Education has issued a report recommending that academic medical centers strengthen their policies regarding relationships with pharmaceutical, medical device, and other health industries in order to ensure an “effective and principled partnership.”
The 39-member task force, which was chaired by the former CEO of Merck and included representatives from industry and academic medical centers, worked for two years on the report. Of particular interest to CME professionals are the recommendations concerning gifts and education.
Audit activities. CME offices should develop audit mechanisms, says the report, to ensure that their activities are in compliance with the Accreditation Council for CME Standards for Commercial Support. The task force also recommends that the AAMC collaborate with theto create an external process for monitoring CME activities, a move that could address the concern expressed in the Senate Finance Committee's April 2007 CME report, which noted the lack of such auditing as a weakness in the ACCME's oversight system.
Centralize CME offices. Management of commercial support should be handled by one centralized CME office within academic medical centers, says the report. Such centralization would not only help AMCs control CME, but would help them manage institutional conflicts of interest, says Barbara Barnes, MD, task force member; and associate dean for CME, University of Pittsburgh School of Medicine. Clarifying that she is making personal comments that do not reflect the official position of the AAMC or any other organizations with which she is affiliated, she says that most medical centers currently have a decentralized model, which presents a major challenge “in capturing the totality of industry support coming through the variety of mechanisms, not only education — certified and noncertified — but research support, foundation gifts, and so forth.”
Nix the gifts. AMCs should prohibit physicians and other, staff, students, and trainees from accepting any gifts from industry, whether those gifts are offered on-site or off-site. Even gifts that are practice-related can create conflicts for physicians and erode their professionalism, the report states. The suggested guidelines would be stricter than the American Medical Association's Ethical Opinion on Gifts to Physicians from Industry, which allows gifts of minimal value that benefit patient care or are practice-related.
Draw the line. Aiming to draw a clear separation between industry-sponsored promotional activities and certified CME, the report recommends that academic medical centers should strongly discourage faculty from participating in industry-sponsored speakers bureaus. (In a letter attached to the report, task force representatives from Pfizer and Eli Lilly & Co. stated that they disagreed with this suggestion.) If faculty do participate, the AMCs should mandate that they disclose the relationship and accept only payments that are fair market value, the report says.
Implementing such policies would require major behavioral and cultural shifts, says Barnes. The report details the “hidden curriculum” in academic medical centers, which teaches students that they deserve gifts and perks from industry. Barnes acknowledges that some physicians feel restrictions on their interactions with industry are “an affront to their professionalism and believe that they have been able to manage these relationships well and do act in the interests of their patients.” To change those deeply entrenched attitudes, the report recommends that AMCs design educational programs to teach students and faculty how gifts can bias their decision-making process. “This is a great opportunity for CME providers across the continuum to work collaboratively with the undergraduate and graduate curricula,” says Barnes, “because we have the most experience in interactions with industry and have thought about these issues for a long time.”
One aspect of industry/CME relationships the report does not recommend curtailing is commercial support. Although funded by a grant from the Josiah Macy Jr. Foundation, interestingly, the AAMC task force did not come to the same conclusions as the Macy Foundation's report, issued in January, which asserted that all commercial support should be phased out over a five-year period. An April 29 New York Times editorial, “Should They Send a Thank You Note?,” found the AAMC report encouraging but felt it should have called for an end to industry support of CME, saying, “It is hard to see why doctors should not pay the full cost of their own continuing education.”
“We all recognize that this is an evolving environment,” says Barnes. “There is a lot more concern about the role of commercial support in CME and the recommendations of the AAMC report are very reasonable given the current environment, but I think we all need to continue to examine this. I don't think any of us know how this is going to look in five to 10 years.”
Overall, Barnes believes that the report's recommendations are achievable, although they may have economic consequences. “These recommendations might cause industry to put their money in other places and develop other strategies for achieving their corporate goals. Some of the recommendations, such as centralization of commercial support, may require new organizational structure and could consume more resources for CME providers.”
But, she says tougher policies are necessary in today's environment. “We are not dealing with only reality, but also perception. This kind of report can reassure the public that we as professional organizations are attending to their concerns. I would hope that these kinds of guidelines would help us to maintain some control, rather than having additional regulatory or governmental control imposed.”
While the report is directed at academic medical centers, Barnes says there are lessons for the wider CME community. “It is important for all CME providers to try to have a shared vision of professionalism and appropriate behaviors and relationships with industry. Reports like this help to stimulate our thinking and can mobilize us as a field to have a more common vision of these issues.”
The 43-page document, which also includes recommendations about pharmaceutical representatives' access to staff, drug sample distribution, ghostwriting, and purchasing, is available at www.aamc.org.
In April, the Massachusetts State Senate passed legislation banning pharma and medical device companies from giving any gifts to healthcare practitioners, their families, and employees of healthcare facilities. If enacted into law, it would be the toughest such legislation in the country.
The Physician Payments Sunshine Act of 2008 was introduced in the US House of Representatives in March. It is the House equivalent of a similar bill introduced in the U.S. Senate last September and would require pharmaceutical and medical device companies to disclose payments and gifts to doctors.