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Controversies
April 18, 2001

Separating Continuing Medical Education From Pharmaceutical Marketing

Author Affiliations

Author Affiliation: Department of Medicine, Channing Laboratory, Harvard Medical School and Brigham and Women's Hospital, Boston, Mass.

 

Controversies Section Editor: Phil B. Fontanarosa, MD, Executive Deputy Editor.

JAMA. 2001;285(15):2009-2012. doi:10.1001/jama.285.15.2009

The pharmaceutical industry has gone too far. It is assuming a role in continuing medical education (CME) that is inappropriate for an industry with a vested interest in selling prescription drugs. Worse, many medical educational institutions not only allow the industry's encroachments but also welcome and even solicit pharmaceutical company participation in programs that should be the profession's sole responsibility. As a result, CME is now so closely linked with the marketing of pharmaceuticals that its integrity and credibility are being questioned. The problem is not new, but it has recently grown to alarming proportions.

Representatives of the pharmaceutical companies say their intention is simply to generate goodwill by helping the providers of CME with the costs of educational programs. That claim might be believable were financial assistance the total extent of their help and were the curriculum content and the educational event totally unaffected by the industry's financial support. But that is not the case. The pharmaceutical industry provides a substantial proportion of the several billion dollars spent on CME annually and uses that support as a marketing tool. It could not invest such large sums without seeking more commercial benefit than mere goodwill and name recognition. The fiercely competitive nature of the prescription drug market plainly requires that companies tie their financial support to the promotion of their products, and that is what they do.

Consider these pharmaceutical industry practices, now common in accredited CME programs, which have the effect of linking financial support of the programs to the marketing objectives of the companies that provide the funding. With the approval of the CME providers, pharmaceutical companies sometimes help organize and advertise the educational event; they may prepare teaching slides and curriculum materials, and they compile lists of possible speakers and indirectly pay them. They also may subsidize practitioners, medical students, residents, and fellows to attend. Attendees are often rewarded by the company with free meals and other amenities. In community hospitals, pharmaceutical companies often organize teaching conferences, and they provide free meals for attendees. At, or adjacent to, virtually all educational sessions subsidized by industry, sales representatives are allowed to display and promote the company's products, particularly the products related to the topic of the program.

The conflicts of interest and the likelihood of biased presentations inherent in such practices are obvious and hardly need elaboration. A recent review article on this subject included evidence showing that industry-supported educational activities are slanted in favor of the financial supporter's products and that physicians attending such courses later prescribe these products more often than competing drugs.1 This should be no surprise to any experienced observer of industry-supported programs. Regardless of their technical pedagogic quality, most presentations are characterized by their friendly treatment of the company's drug. The company's mission is to sell its products, and it uses its participation in CME to further that end. Support for CME comes from the marketing budget in most companies, and that budget must produce sales. A spokesman for the industry's trade association, the Pharmaceutical Research and Manufacturers of America, put it succinctly in a recent newspaper article about industry-supported CME: "Companies live through education," he said.2 The detailing of individual physicians in practice, all-expenses-paid symposia for physicians in posh resorts, and mass advertising to the profession and the public all serve the same purpose. Like CME, they are called education by the pharmaceutical industry, but they are all intended to promote sales.

The true purpose of pharmaceutical support of CME is perhaps most clearly revealed by the growing new industry called Medical Education and Communication Companies (MECC). These for-profit companies, now numbering more than 100, put together educational programs to be presented in hospital grand rounds and in freestanding CME presentations, and they prepare various other teaching materials for physicians. The MECCs are paid mainly by pharmaceutical companies, and they supply their educational programs gratis to hospitals, other CME sponsors, and individual physicians.3 Astonishingly enough, many MECCs are accredited by the medical profession's Accreditation Council on Continuing Medical Education (ACCME), and therefore can take full responsibility for independently sponsoring their own accredited CME programs. Thus, the hired agents of pharmaceutical companies are given authority for the content of CME programs. Even more astonishing, the ACCME has accredited a major pharmaceutical company and several foundations and institutes that are closely affiliated with pharmaceutical companies.

According to a report recently released by the Public Citizen's Health Research Group in Washington, DC, MECCs (called Medical Education Service Suppliers or MESSs in the report) are candid in explaining the real purpose of their business to prospective pharmaceutical industry clients.3 For example, one company says, "Medical education is a powerful tool that can deliver your message to key audiences and get those audiences to take action that benefits your product." Another firm advertises itself as "Putting the science of medicine to work for you. Preparing and building the market through professional education." Still a third says it is a business that "never loses sight of the strategic value of [its] programs to enhance its client's corporate image and to strengthen brands." The MECC industry, as described in the Public Citizen's report, was the subject of a recent editorial comment by The Lancet, which expressed concern "that so much continuing medical education comes through the filter of industry."4

Although the pharmaceutical industry is seriously misguided in becoming so deeply involved in CME, more fault lies with the professional providers of the accredited CME programs that have allowed and even encouraged this involvement to grow. After all, the pharmaceutical industry is doing what is expected of any business, ie, trying to maximize its sales. However, the professional educators in CME programs who deal with pharmaceutical products are failing to do what the medical profession and society at large expect of them. They are supposed to be teaching physicians how to serve their patients' interests by acting as informed, unbiased evaluators and prescribers of therapeutic agents. Does anyone really believe that medical educators are properly doing their job when they allow the pharmaceutical industry not only to subsidize their educational costs but also to help prepare the curriculum, recommend and pay the speakers, indirectly pay students and residents to attend, lavish free meals and other favors on attendees, and then promote the company's products at the meetings? Also, if physicians responsible for medical education in hospitals accept the free prepackaged educational programs of a MECC, can they possibly think they are fully meeting their responsibilities as educators of a supposedly independent profession?

Medical educators who see nothing wrong with the current situation apparently rely on a document that is supposed to establish guidelines protecting the integrity of the educational process. Initially promulgated by an informal working group called the National Task Force on CME Provider/Industry Collaboration, these guidelines were incorporated with minor changes into the ACCME's Standards for Commercial Support of Continuing Medical Education in 1992.5 They were later also adopted with minor modification by the American Medical Association (AMA) as part of its requirements for the Physicians Recognition Award. As promulgated by the ACCME, these standards leave much to be desired. They are permissive and ambiguous where they ought to be firm and clear. They allow the pharmaceutical companies and the medical education companies they hire to do all of the things described herein as long as the accredited educational sponsors of the programs know and take final responsibility for what is done. In addition, when the medical education company itself is accredited, even those perfunctory guidelines can be bypassed.

The standards also require disclosure of "any significant financial interest or other relationship a faculty member or the sponsor has with the manufacturer."6 However, neither disclosure nor the taking of "responsibility" by the accredited CME provider ensures that attendees will hear a presentation free of commercial bias. Conspicuously missing from the standards is the injunction found in the AMA's Code of Medical Ethics, which states that CME faculty may accept "technical assistance" from industry in preparing educational materials as long as the company "has no input in the actual content of the material."7 Any kind of involvement of industry in the educational program, including technical assistance, is unwise, because it makes strict implementation of the "no input" rule almost impossible. A recent commentary by a former chairman of AMA's Council on Ethical and Judicial Affairs called for "more detailed guidelines" and suggested new discussions between the medical profession and industry to develop "industry-wide standards" for their interaction in CME programs.8 This is not reassuring to anyone who understands the marketing imperatives of the pharmaceutical industry. A blanket prohibition of anything more than unrestricted financial support would be better. Without such a clear statement, guidelines for "collaboration" and "interaction" are inevitably going to be open to varying interpretations and to influence by industry. Avoidance of conflicts of interest, when possible, is always preferable to "managing" or simply disclosing them.

The permissiveness of the current standards adopted by the ACCME was predictable, given the industry representation on the task force that first drafted them. Almost half of the current task force members are representatives of the pharmaceutical industry or are consultants for businesses that work with the industry in preparing educational programs. Only a few represent academic CME institutions. Although this self-appointed group acknowledges that it operates informally, without mandate or official status, it seems nevertheless to have exercised considerable influence over CME policies and practices. I find it disturbing that neither ACCME nor any of its constituent bodies, such as the AMA, the Association of American Medical Colleges, the American Board of Medical Specialties, the Council of Medical Specialty Societies, the American Hospital Association, or the Federation of State Medical Licensing Boards, have taken a more active role in limiting relationships between industry and CME. Undeterred by the troubling conflicts of interest in such relationships, the medical educational establishment has so far been unwilling or unable to take stronger action.

Last year 55 members of the Society for Academic Continuing Medical Education, representing 48 medical schools, presented a resolution that in effect would have prevented businesses, such as MECCs and pharmaceutical companies, from independently creating their own CME programs and awarding AMA/Physician Recognition Award credits to the physicians who attend. The signatories said they believed this authority "must remain the exclusive responsibility of the medical profession."3 According to USA Today,2 the resolution was ultimately tabled by the leadership of the Society for Academic Continuing Medical Education because of its concern about losing industry support of academic CME programs and because of the threat of a class action lawsuit by the MECC industry. A spokesman for the MECC trade group was quoted as saying, "As long as we meet the same standards, we have a right to participate."2 But to whose "standards" does he refer, and what "right" does he invoke?

It is unfortunate there has been no effective challenge to this intrusion of for-profit businesses into the affairs of not-for-profit professional institutions. The above-named institutions and the ACCME must bear some responsibility for not facing this issue earlier and having allowed this intrusion in the first place. If the ACCME were forced to defend itself in a lawsuit, would the courts really make no distinction between professional medical education and commerce, and would they really deny ACCME and its constituents the freedom to determine which organizations they can accredit? I suspect a more realistic fear of the ACCME and the entire CME community is the loss of financial support from the pharmaceutical industry that might follow adoption of stricter policies.

If medicine wishes to continue as an autonomous profession, it should at least reclaim its full responsibility for CME. That means keeping the pharmaceutical industry at arm's length from professional education. Financial support from industry should be accepted by accredited educational providers only with the clear understanding that there will be suitable acknowledgment of support but no collaboration of any kind and no marketing links with the program. I see no objection to large specialty society meetings that offer CME credit being supported in part by commercial exhibits. However, the exhibits should be appropriately separated from the meeting rooms, and there should be no connections between companies and specific program sessions or topics.9

The ACCME should accredit only medical professional institutions and associations that can independently provide programs of good quality, and it should not accredit pharmaceutical companies, their agents, or medical education businesses. In a free economy such as ours, these businesses should be allowed to sell or give their "educational" products directly to physicians who may want them, but the line should be drawn at professional accreditation of these businesses and at any kind of collaboration between them and accredited educational providers. Those CME providers incapable of independently organizing and presenting their own programs should not be accredited; there are too many accredited national and regional CME providers anyway. A reduction in their number would probably strengthen the academic quality and professional independence of those that remain and would promote more oversight of nonaccredited educational programs by qualified and accredited teaching institutions.

If the pharmaceutical companies were unwilling to continue their "unrestricted" support of CME under these terms, so be it, and so much for their claim that they are seeking only good will and not increased sales. Collaboration in education is different from collaboration between industry and academic medicine in research. Assuming appropriate regulation, there may well be good reasons to breach the "academic-industrial wall"10 in medical research. Rapid and effective translation of basic research to practical applications in drug therapy and medical devices often requires collaboration between academic medicine and industry. Industry has legitimate research interests and research capacity. It can make valuable contributions in advancing research leads that originate in academic laboratories and in helping with clinical studies. The situation is different in professional education, which ought to be the exclusive preserve of medical educational institutions. The latter can share their responsibility with industry only at the risk of losing their independence and their objectivity. Reassertion of professional values in CME may require a willingness to forgo some or all pharmaceutical industry support. But that would be far less damaging to medicine than a continuation of the current situation, in which CME is increasingly used as a promotional tool by the industry and businesses hired by pharmaceutical firms are increasingly being accredited to create their own "educational" programs.

Most practicing physicians can afford to pay for their continuing education. If they are employed, subsidies for CME should be a fringe benefit. In addition, most professional institutions capable of providing good CME can afford to provide it at cost, without subsidies from the pharmaceutical business. As commercialism threatens to overwhelm us, it is high time we physicians reaffirm our support for the enduring values of our profession. One important step is to recognize that CME must be clearly separated from pharmaceutical marketing. Physicians may even have to pay more for CME but then may value it more, demand higher quality, and learn more from it. Most of all, we would have a better chance to retain our professional self-respect and the trust of patients and the general public.

Editor's Note: The Accreditation Council on Continuing Medical Education (ACCME) of the American Medical Association was invited to submit an article discussing its position on continuing medical education sponsored by the pharmaceutical industry, but declined to do so.

References
1.
Wazana A. Physicians and the pharmaceutical industry.  JAMA.2000;283:373-380.
2.
Vergano D. Who's teaching the doctors?  USA Today.March 9, 2000;D:1.
3.
Ross JS, Lurie P, Wolfe SM. Medical Education Services Suppliers: A Threat to Physician Education. Washington, DC: Public Citizen's Health Research Group; July 19, 2000. (This is based on a survey in Medical Marketing & Media. 2000;24:40-80.)
4.
 Drug-company influence on medical education in USA.  Lancet.2000;356:781.
5.
American Medical Association.  The Physicians Recognition Award Information Booklet for CME Providers: Version 3.0Chicago, Ill: AMA.
6.
Accreditation Council on Continuing Medical Education.  Essential, guidelines and standards. In: Standards for Comercial Support of Continuing Medical Education. March 20, 1992: 18-22.
7.
Council on Ethical and Judicial Affairs, American Medical Association.  Ethical opinion 8.011. In: Code of Medical Ethics, Current Opinions With Annotations. Chicago, Ill: Council on Ethical and Judicial Affairs, American Medical Association; 2000.
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Tenery Jr RM. Interactions between physicians and the health care technology industry.  JAMA.2000;283:391-393.
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Pellegrino E, Relman A. Professional medical associations: ethical and practical guidelines.  JAMA.1999;282:984-986.
10.
Martin JB, Kasper DL. In whose best interest? breaching the academic-industrial wall.  N Engl J Med.2000;343:1646-1649.
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