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Should Standards for Commercial Support Be Changed?
Lew Miller (excerpted from article submitted to Medical Marketing & Media)
In mid-summer, the ACCME's Task Force on Standards for
Commercial Support heard and read into the record
testimony from ACCME's parent organizations, CME and credit-
granting organizations and international information
sources. Were the current standards, adopted in 1992, too
stringent, not tough enough or just about right? asked Task
Force chair Dr. Norman B. Kahn Jr., vice president for
education and scientific affairs of the American Academy
of Family Physicians.

Stephen C. Shelber, MD, executive vice president of the
American Board of Psychiatry and Neurology, proposed
banning all commercial support for CME in order to
preserve "the integrity" of the certification system.
sures" such as not allowing mention of sponsor's products. This, he says, will ultimately "compel the industry to abandon its current sponsoring of CME. . It may be that the only way to make CME truly objective . would be to prohibit any kind of commercial sponsorship."

Gerald B. Holzman MD, retiring vice president for education of the American College of Obstetricians and Gynecologists (ACOG), slammed the marketing practices of the industry quite vigorously.

He wants to see clearer separation between education and promotion. He views this as a problem the entire profession must deal with, not just the ACCME.

The anti-industry testimony prompted ACCME Task Force member Elliott L. Mancall MD of the American Academy of Neurology, to ask: "If we got rid of commercial support, would there still be bias?" Barbara E. Barnes MD said "No." She is president of the Society for Academic Continuing Medical Education (SACME), representing the nation's medical schools, by far the largest providers of CME.

Robert Cullen PhD, of the National Task Force on CME Provider/Industry Collaboration, was not at all sure. Bias would not disappear if only pharmaceutical company support were banned, he suggested. Cullen, CME leader in the Department of Veterans Affairs, argued that the definition of "commercial support" should include all organizations with self-interest -- including consultants, medical schools and hospitals - not only the pharma companies.

Not many of those testifying were willing to say that the standards were too tough. A few unidentified members of the Alliance for Continuing Medical Education were quoted as saying "that an opportunity exists to modify current standards to allow greater flexibility in the solicitation and uses of commercial support."

Speaking on behalf of the Global Alliance for Medical Education (GAME), I said that the standards "would have a difficult time gaining support in most countries outside the U.S., Canada, Great Britain and Australia. It would be inappropriate to impose them on other countries as a condition of reciprocal accreditation." Daniel Ostergaard MD, vice president, international, of the AAFP, was in agreement. Countries in Europe and Latin America are just beginning to move toward accreditation of CME, and are not in a position to develop detailed guidelines on commercial support.

Most of the 170 written and spoken comments received by the Task Force felt that the Standards were still OK. "The Standards are remarkably robust," said Dennis K. Wentz MD, director of continuing physician professional development of the American Medical Association (AMA). He presented testimony from Richard Allen MD, chair of the AMA's Council on Medical Education, who wrote:

"We were all struck with how relevant and effective the guidelines still are near ten years later. They . have contributed greatly to the practice of CME in the current environment of medicine. [and] still contribute to maintaining the integrity of the CME enterprise."

Most respondents from the parent medical specialty boards, other than the Board of Psychiatry and Neurology, felt that the Standards were functioning well and needed no major changes. So did members of the Alliance and representatives of allied health organizations. Eliminating commercial support, said Bruce J. Bellande PhD, executive director of the Alliance, "would create an unmanageable situation."

What were the most frequent modifications suggested? These are not ranked by importance:

1. Provide specific guidelines for commercial support of CME on the Internet.

2. Stress educational outcomes rather than paperwork documentation of adherence to the standards.

3. Broaden the section on discussions of "Unlabeled Uses" to include a full range of diagnostic and treatment options that have not yet been approved - not only drug therapy. Also require clear alerts to the audience when such uses are discussed.

4. Reduce commercial supporters' involvement in planning, producing audio-visuals and social activities.

5. Monitor faculty disclosures of conflict of interest more closely.

6. Ask physician participants to evaluate bias, if any.

7. Curtail the upward spiral of gifts to physicians, including expensive meals

One other issue surfaced more than once: the matter of enforcement of the Standards for Commercial Support. Donald E. Moore Jr. PhD, president of the Alliance, wants to see the ACCME "bring to task the 5% of accredited providers who do some mischief." Dr. Barnes of SACME commented on the "number of providers who are currently out of compliance."

In the minds of some, the enforcement issue applies primarily to for-profit CME providers. Dr. Shelber of the Board of Psychiatry and Neurology took a swipe at the "too many for-profit CME providers who have joined forces with the pharmaceutical industry to provide programs that meet the letter of the law of the 1992 regulations but are extremely, if not overly, kind to the products of the sponsoring company." When Dr. Kahn asked, "If regulations are tightened, won't that place a burden on providers?" Dr. Holzman of ACOG replied: "That's only a problem for for-profit providers!"

About 20% of providers on the ACCME's accredited list are for-profit. Jacqueline Parochka, vice president for CME of Discovery International and a director of the Alliance, voiced a mild rebuttal. "Medical education and communications companies have been wrongly perceived as the outliers," she commented. "We have formed a new association of these companies to represent their interests and quality standards."

Will the Standards be tightened - and, if so, how much? Will tighter Standards drive marketing dollars away from accredited CME, into forms of promotional "education"?

The Task Force will take its time coming to recommendations, says its chair, Dr. Kahn. A final report is probably a year away. We have to decide whether "to scrape barnacles or rebuild". Meantime, he says, we have to reach out to the commercial supporters and the Food and Drug Administration (FDA) for their input.