Whose doctor?? Follow the money…

Commercial Support and Continuing Medical Education

Robert Steinbrook, M.D.

The majority of the financial support for continuing medical education (CME) in the United States comes from drug companies and other commercial entities (see graph).¹ Total commercial support more than tripled between 1998 and 2003 ”” from $302 million to $971 million. CME should aim to improve health care and should be totally independent of commercial interests, but there are long-standing concerns that it often involves marketing as well as education.² For example, about 100 accredited U.S. providers of CME are for-profit medical education and communication companies, or MECCs. They are hired by pharmaceutical firms to organize meetings, find speakers for grand rounds and symposia, and develop written materials. MECCs receive about 90 percent of their income from commercial support.¹

View larger version (12K): [in this window] [in a new window] Income and Expenses for Accredited Continuing Medical Education in the United States, 1998-2003. Total income is the sum of commercial support, registration fees and other income, and advertising and exhibit income. Most commercial support is received from firms that manufacture products regulated by the Food and Drug Administration. Data are from the 2003 annual report of the Accreditation Council for Continuing Medical Education.1

Although there are no overall data on the frequency of commercial bias in CME, some of the physicians who are invited to speak at CME events or to organize them have extensive financial relationships with industry and have been paid to give other talks as part of the speakers’ bureaus of drug companies. “Faculty may use the same material from a drug-promotion event at a CME course without fully recognizing that they are doing this,” said Dr. Richard Van Harrison, director of the office of CME at the University of Michigan Medical School. “Qualitatively the problem is not new, but quantitatively it is, because many more people are being hired to be speakers for drug companies.”

According to the Accreditation Council for Continuing Medical Education (ACCME), CME “is professional education created for the medical profession by the medical profession or its agents.”³ The council’s updated “Standards for Commercial Support,”⁴ which were approved in September 2004 and replaced those that had been in effect since 1992, are its latest effort to safeguard the independence and integrity of these activities. In 2003, there were about 67,000 CME activities presented by 697 accredited providers, an increase from 48,000 activities and 632 providers in 1998.¹ The organizations that provide CME include medical societies (among them the Massachusetts Medical Society), specialty organizations, medical schools, hospitals, and medical publishers.

The updated standards are effective for new CME activities after May 2005, and for all CME activities by November 2006. Under the council’s old standards, CME faculty and providers had to disclose their commercial relationships. They have not always done so, but that was the expectation. Under the new standards, disclosure is no longer sufficient. Not only do relevant financial relationships within the past 12 months have to be disclosed, but conflicts of interest must be resolved before the educational activity occurs. Moreover, the requirements apply not only to the providers, the speakers, and the authors of written materials, but also to the physicians and others who work behind the scenes to plan events and recruit speakers and authors. According to Dr. Murray Kopelow, chief executive of the ACCME, “We are requiring the providers of CME to take an active role in resolving conflicts of interest. This will have an important positive impact.”

Many physicians who participate in CME activities may be affected by the new standards, although many may not yet be aware of them. For example, at meetings of large specialty societies, there maybe hundreds, if not thousands, of faculty presenters. In general, there will be three ways to resolve conflicts of interest: find another speaker, assign the speaker a different topic, or have an effective peer review of the content of a talk or written material, so that unsubstantiated and promotional content can be eliminated. Organizations are still determining how to abide by the new standards, so it is too soon to say what differences, if any, these standards will make in specific educational activities.

The ACCME defines financial relationships as “a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit.”³ In the updated standards, the council has not set a minimum dollar amount, because it determined that “inherent in any amount is the incentive to maintain or increase the value of the relationship.” The council believes that the potential for a person to make more money “creates an incentive to influence the content of the CME ”” an incentive to insert commercial bias.”³

An accredited CME provider must make key decisions free of the control of commercial interests and cannot be required to accept advice from a company about teachers, authors, participants, or content as a condition of receiving funds or services. Industry, however, can have input in other ways. Commercial supporters “can raise issues with the provider about content,”³ and providers may ask sponsoring companies for suggestions regarding topics or speakers.⁵

The ACCME has seven member organizations ”” the American Board of Medical Specialties, the American Hospital Association, the American Medical Association, the Association for Hospital Medical Education, the Association of American Medical Colleges, the Council of Medical Specialty Societies, and the Federation of State Medical Boards of the United States. It has a staff equivalent to 13 full-time employees and an annual budget of about $3 million. It will not be known for some time how the council will interpret its standards in specific situations and monitor compliance, nor how the new standards will affect its accreditation decisions. One approach might be for the council to survey CME participants about potential commercial bias ”” although participants may not be the group most likely to detect such bias. Another approach might be to work with medical groups to train volunteer observers who would attend activities and report back. It is also uncertain whether the new standards will primarily place an administrative burden on CME providers or, in fact, lead to substantive changes in the content of educational activities.

CME that is balanced and free from bias is in the overall interests of physicians and patients. Yet given the underlying economics of CME and the small size of the ACCME, the goal of independence from commercial interests may be difficult to achieve. More direct approaches might be to limit the percentage of commercial support that is permitted for a CME activity or for the ACCME to stop accrediting MECCs, as some have suggested. If the new standards make support for CME seem less valuable to industry, companies may decrease their support. If they do, the medical profession may have to assume more of the true cost of its own continuing education.

Source Information

Dr. Steinbrook is a national correspondent for the Journal.

References

1. Accreditation Council for Continuing Medical Education. Annual report data 2003. (Accessed January 21, 2005, at http://www.accme.org/dir_docs/doc_upload/97dd7a39-9746-4a5d-8c01-e56a9ffc0c8b_uploaddocument.pdf.)

2. Angell M. The truth about the drug companies: how they deceive us and what to do about it. New York: Random House, 2004.

3. 2004 Updated standards for commercial support: with background rationale and answers to questions about compliance. Chicago: Accreditation Council for Continuing Medical Education, September 2004.

4. Standards for commercial support. Chicago: Accreditation Council for Continuing Medical Education, September 2004.

5. 2004 Updated standards for commercial support: additional questions and answers. Chicago: Accreditation Council for Continuing Medical Education, October 20, 2004.