The report released in April by the Institute of Medicine, called “Conflict of Interest in Medical Research, Education, and Practice,” is raising a bit of a ruckus in the continuing medical education community. Among its many recommendations for managing COI in institutions that conduct medical research, develop practice guidelines, provide clinical care, and offer medical education, is one that could turn CME as we know it on its head: Recommendation 5.3. It reads: “A new system of funding accredited continuing medical education should be developed that is free of industry influence, enhances public trust in the integrity of the system, and provides high-quality education.”
It calls for CME accrediting bodies, including the Accreditation Council for CME, certification boards, and others, to develop a consensus on a new funding system that will meet IOM's stated goals — within 24 months of the IOM report's publication.
Many who have been pushing to get the pharmaceutical and biomedical device industry out of CME altogether greeted the IOM's recommendation with open arms. Others, including many CME providers, are saying that ejecting all commercial support is unreasonable, un-necessary, and ultimately impractical.
A Great Idea
Among those who heralded the IOM's conclusions as a long-needed boon was Sen. Chuck Grassley (R-Iowa). Grassley's position on the topic is well known: He recently co-sponsored the Physician Payments Sunshine Act of 2009, S.301, with Sen. Herb Kohl (D-Wis.). The so-called Physician Sunshine Act, if passed, would require pharma and medical device and biomedical manufacturers to publicly report any funds over $100 given to physicians and those who do biomedical research and provide continuing medical education. IOM makes a similar recommendation.
Grassley also issued a report two years ago after an investigation of pharma funding of various medical activities, including CME grants. At the time, he toldin a written statement: “We found that there are risks of kickbacks, veiled advertising of drugs, efforts to bias clinical protocols, and off-label promotion.”
In a statement to the press shortly after the IOM report was released this spring, Grassley called it “a shot in the arm to the reform movement to have the prestige and policy heft of the Institute of Medicine on the side of transparency. The more disclosure, the better, for holding the system accountable and building public confidence in medical research and practice.”
And Grassley isn't alone. There's a growing movement, detailed in the April 1, 2009, issue of the Journal of the American Medical Association, of physician leaders calling on professional medical associations to sever most of their ties with drug with and device companies. While it does not directly address the IOM report, it does propose that medical societies aim to ban all pharma and medical device industry funding except for income from journal advertising and exhibit halls.
No Way, No How
There are other voices, however, raised in objection to the IOM's call to rid CME of all industry ties. The Coalition for Healthcare Communication's executive director, John Kamp, for example, calls the IOM recommendations “both naïve and foolish.” In a written response to the IOM report, the Coalition objects that “No public mention was made of the significant regulatory policies” of the Food and Drug Administration, the Department of Health and Human Services, the voluntary Pharmaceutical Research and Manufacturers of America and Advamed's codes on interactions with healthcare providers, or even the Accreditation Council for CME's Standards for Commercial Support, which includes specific requirements CME providers must adhere to in the area of COI to achieve and maintain accreditation.
The coalition statement adds, “One could surmise that these newly enacted reforms and recent guidelines were either ignored or deemed ineffective — potentially an embryonic decision without the hard data to support such sweeping recommendations.” The coalition also objected to the IOM's recommendation that doctors not participate in promotional programs whose content is controlled by industry, even though “the report recognizes that industry must control the presentations because of FDA rules.”
PhRMA's senior vice president, Ken Johnson, also objected to the report's conclusions on many accounts. When it comes to CME, he said in a statement that the PhRMA code already provides COI safeguards. It “states that funding for CME should support a full range of treatment options and not promote a particular product; companies should separate CME grant-making decisions from sales and marketing departments; and companies should follow CME accreditation standards and respect the independent judgment of CME providers.”
A joint statement from the American College of Cardiology, the American College of Emergency Physicians, the American College of Radiology, the American College of Rheumatology, the American Gastroenterological Association, and the American Society of Plastic Surgeons, also points to adherence tostandards, in addition to their own “stringent internal policies that ensure that our educational and scientific content remain unbiased,” and their commercial supporters' adherence to the PhRMA code, as current safeguards against COI. The statement also says that, should the recommendations come to fruition, physician education could suffer.
“Without continued external support from industry, our societies will be unable to provide the same level of outstanding education and cutting-edge science that has advanced the quality of patient care in this country.” While they would welcome public funding as a way around the potential for bias, they say that industry funding does not have to mean biased programs when proper firewalls are in place.
What do you think about IOM's recommendation to come up with a commercial-support-free way of funding CME? E-mail your thoughts and suggestions to Sue Pelletier at email@example.com.