Voluntary self-regulation of CME sponsorship debated
■ A column that answers questions on ethical issues in medical practice
The Ethics Group provides discussions on questions of ethics and professionalism in medical practice. Readers are encouraged to submit questions and comments to [email protected], or to Ethics Group, AMA, 515 N. State St., Chicago, IL 60654. Opinions in Ethics Forum reflect the views of the authors and do not constitute official policy of the AMA. Posted Dec. 6, 2004.
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Can continuing education providers, adhering to proper guidelines, develop CME that meets ethical requirements for professional education and is free of commercial marketing if the CME is supported by a grant from the pharmaceutical industry?
The short answer to this question is yes -- when providers and financial supporters of continuing medical education, in partnership, understand, accept, and adhere to the current voluntary, self-regulatory standards of the profession, CME will meet ethical requirements for professional education.
CME has been a centerpiece of professionalism in medicine for more than half a century. The concept of continuing to be educated throughout a career has communicated to the public that physicians are keeping up with medical advances.
In 1948, the newly formed American Academy of General Practice (now the American Academy of Family Physicians) incorporated into its bylaws a triennial membership requirement for 150 hours of CME. In 1968, the American Medical Association created the Physician's Recognition Award, promulgating the expectation for CME to all of allopathic medicine. The American Osteopathic Assn. followed suit in 1973.
The Accreditation Council for Continuing Medical Education was formed in 1980 to accredit CME providers who may then award AMA PRA category 1 credit. The systems created by these organizations continue to work in concert to accredit CME providers and activities and to grant CME credit in the United States.
CME earns its value through dissemination. For many CME activities, there's either little cost (as in local Grand Rounds), or the costs are wholly borne by physicians (as in many specialty society home study programs). Other valuable CME products cost more to disseminate, such as journal CME, where the costs are often underwritten through the sale of commercial advertising. Providers of CME have used financial support from proprietary companies, predominantly from the pharmaceutical industry, as well as from the manufacturers of medical and surgical devices, to underwrite the costs of developing and more widely disseminating CME for physicians.
Prior to 1992, in an unregulated environment, the promise of financial support often swayed providers to accept corporate influence on CME activities. That influence took the form of speaker selection, inclusion of specific content, and even targeted audiences, resulting in what the profession and the public considered to be biased CME at best and promotional marketing at worst. The response of the profession was to undertake national voluntary self-regulation through the Standards for Commercial Support of CME, adopted by the ACCME in 1992 and shortly thereafter by the AAFP, AMA and AOA.
Professionalism, where the interests of patients and the public are put first, is monitored by society as well as by the profession. The more successfully the profession monitors and voluntarily regulates itself, the less likely societal monitoring will turn to regulation of the profession. Who are the societal regulators of medical professionalism in the United States? There have been three that have monitored the relationships between physicians and industry: the legislative and executive branches of government and the American media. All three have been active. Congressional hearings in the early 1990s were followed by Food and Drug Administration guidance and television exposés.
It is primarily the responsibility of providers of CME to understand and follow the national Standards for Commercial Support of CME, while it is incumbent on industry to support and not undermine this professional responsibility.
When failures occur, they are due primarily to providers not following the standards, either through ignorance or inexperience or through bowing to pressure from industry.
What role do more recent additions to the voluntary self-regulatory environment play, such as the Code on Interactions with Healthcare Professionals, adopted in 2002 by the Pharmaceutical Research and Manufacturers of America; and the Code of Ethics for Interactions with Health Care Professionals, approved in 2003 by the Advanced Medical Technology Assn.? These codes of expected behavior are welcome vehicles through which industry participates in a partnership of voluntary self-regulation of relationships with physicians.
The most recent threat of external regulation, now from the Office of Inspector General of the Dept. of Health and Human Services, reflects the gravity with which society views the relationships between physicians and industry. Rather than prohibiting relationships between CME providers and commercial supporters, the executive branch has recognized that the continued development and dissemination of CME has important value to society and that financial support can facilitate that social benefit. The OIG puts the partnership between CME providers and commercial supporters on notice when it states, "Codes of conduct promulgated by the CME industry may provide a useful starting point for manufacturers when reviewing their CME arrangements."
Can the profession, through the ACCME in partnership with the AAFP, AMA, and AOA, successfully facilitate voluntary self-regulation? Yes, through the continuous cycle of quality improvement, including standard-setting, education, monitoring, feedback and behavior change. On Sept. 28, this partnership took the most recent step in that cycle when the ACCME adopted the revised and updated Standards to Ensure the Independence of CME for physicians.
Norman B. Kahn Jr., MD, vice president for science and education, American Academy of Family Physicians; board member, Accreditation Council for Continuing Medical Education; chair, ACCME Task Force that revised the Standards for Commercial Support of CME; member, AMA-convened National Task Force on CME Provider/Industry Collaboration
Professional education is fundamentally different from marketing and is the responsibility of the medical profession, not the pharmaceutical industry. For professional education to be "free of commercial marketing" it should be organized and provided by professional medical educational institutions that are under no constraints to produce programs of interest to commercial sponsors. Educational institutions -- medical schools, teaching hospitals, and professional societies -- should independently decide what subjects are covered, how they are presented, and who does the teaching, without any influence by commercial interests.
As a practical matter, no guidelines can assure that CME will be uninfluenced by industry if commercial sponsors are allowed to assist in any way with the programs; if medical education and communication companies (MECCs) paid by pharmaceutical sponsors are accredited as independent providers; or if speakers are permitted to have financial arrangements with commercial sponsors.
The new Accreditation Council for Continuing Medical Education guidelines are stronger than the old ones, but do not rule out these problematic arrangements and, hence, do little to avoid the conflicts of interest that make commercial influence possible. Furthermore, there are insufficient provisions for oversight and enforcement of the rules -- which depend too much on voluntary compliance. The only guideline we ought to have should simply say industry and its paid agents, medical education and communication companies, will have absolutely no connection with the arrangements, content, or presentation of CME.
These accredited MECCs are growing in number and influence, and this problem is not even addressed by the new ACCME guidelines. Yet it is hard to imagine how CME provided through the auspices of such companies, which are paid by the pharmaceutical firms (and are sometimes owned by pharmaceutical advertising companies), can possibly be uninfluenced by commercial considerations. I suspect that an important reason ACCME hesitates to deny accreditation to MECCs is its fear of litigation. But ACCME and its constituents are all private nonprofit entities, and they should be free to establish their own rules for CME accreditation. The law ensures MECCs freedom to offer what they may choose to call medical education to any physicians who may want to listen, but it cannot require ACCME to accredit or cooperate with MECCs. A profession surely has the right to set its own educational requirements and to decide who will provide accredited education for its members.
If pharmaceutical companies really wanted to make totally unrestricted grants to support CME they could do so directly, without having any further connection with the professional educational system and without involving MECCs as intermediaries. But that is unlikely to happen.
Everyone knows that the industry's CME grants (to MECCs and to educational institutions) are marketing tools primarily intended to generate sales, and there is ample evidence that they succeed in achieving that commercial purpose. Company executives could not justify these large expenditures to their boards of directors if there were no return on their investment. The truth is that pharmaceutical companies are not professional medical educators and they should not pretend that they are. They are businesses primarily concerned with finding, developing, and selling drugs, and they ought to stay on their own turf.
The professional educational institutions explain their acceptance (often, their solicitation) of industrial support and participation by arguing that they could not otherwise afford the cost of CME. I am not convinced.
The cost of CME programs could be reduced considerably without loss of educational quality if educational institutions were to use all the pedagogic resources available to them (including any salaried full-time clinical faculty), if CME students were willing to pay more of the tuition costs, and if the arrangements for CME events were more modest. The medical profession does not really need the help of the pharmaceutical industry to meet its responsibilities for CME. And it should not accept that help if it wishes to maintain its self-respect and the trust of the public.
Arnold S. Relman, MD, former editor of the New England Journal of Medicine; professor emeritus, medicine and social medicine, Harvard Medical School
The Ethics Group provides discussions on questions of ethics and professionalism in medical practice. Readers are encouraged to submit questions and comments to [email protected], or to Ethics Group, AMA, 515 N. State St., Chicago, IL 60654. Opinions in Ethics Forum reflect the views of the authors and do not constitute official policy of the AMA.