Healthy Skepticism Library item: 2171

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Greene J.
Rules governing drug firm CME sponsorship under review
amednews.com American Medical Association 2001 Aug 6
www.ama-assn.org/sci-pubs/amnews/pick_01/prsb0806.htm

Full text:

Should pharmaceutical companies continue to sponsor continuing medical education conferences?

If the answer is “yes,” then another question follows. Should rules governing sponsorship of CME activities be tightened to give the public and physician community greater confidence that there is a clear separation between drug company marketing and essential medical education?

A four-member task force will address these and other questions during a year-long process to revise the Accreditation Council for Continuing Medical Education’s “Standards for Commercial Support.” The standards are a six-page set of rules that accredited CME providers must follow when accepting donations from pharmaceutical companies.

During the last several years, questions have arisen both from the public and from some physicians about whether drug company involvement in CME activity planning unduly influences physician learning.

Under the standards, drug companies are allowed to provide some input into CME activities. However, “the design and production of educational activities shall be the ultimate responsibility of the accredited provider,” according to the standards.

But in the 10 years since the standards were created to head off government regulation, the amount of drug company funding for CME activities has grown steadily. About half of the $1.2 billion costs of CME are now underwritten by drug firms with some 522 accredited CME providers accepting an average of $686,000 in donations.

“The number of providers who are currently out of compliance with the various elements of the standards causes concern about the clarity of the regulations and the existing processes for their dissemination,” said Barbara Barnes, MD, president of the Society for Academic Continuing Medical Education, based in Birmingham, Ala.

At an ACCME task force hearing last month, Dr. Barnes was one of a dozen experts representing the ACCME’s parent organizations, accredited CME providers and other organizations who spoke on the need to change the standards. Some also voiced concern that making the rules more stringent would increase out-of-pocket CME costs for physicians.

One complaint per week
None of the speakers cited specific examples of conflict of interest in which a CME conference, course or faculty member was unduly influenced by drug company financial support. But the ACCME receives about one complaint a week from doctors about CME activities and finds several accredited providers each year out of compliance with the standards.

Some experts, however, said the standards offered drug companies too much “wiggle room” by allowing them some involvement in planning CME activities and providing educational materials such as slides and reference materials.

The American Academy of Orthopaedic Surgeons said online CME should be included in the standards. “We would look to the task force to provide guidance on such questions as where commercial advertising and other forms of support may be positioned on a Web site that carries online CME for credit,” the academy said.

Echoing that suggestion, the American Academy of Family Physicians said the standards could be changed to apply to all CME activities, including online CME, journal-based CME and enduring materials. The current standards apply only to live CME activities.

And at least two CME officials called for the ACCME to prohibit drug companies from becoming accredited CME providers.

“We would disallow assistance from commercial entities in the production of slides, handouts, syllabi and bibliographies,” said Gerald Holzman, MD, an obstetrician and gynecologist representing the Council of Medical Specialty Societies. “We would not permit commercial entities to assist in marketing educational activities. We would not permit accredited providers to offer CME activities produced by proprietary interests.”

On the other hand, Bruce Bellande, PhD, executive director of the Alliance for CME, Birmingham, Ala., a group of CME professionals, said opinions from an informal survey of 54 of its members showed most favor clarifying language but that the standards are essentially still relevant.

“There is concern that changes to the current standards may cause an increased burden to providers while not providing the learner with useful information,” Dr. Bellande said.

Although representatives of the Pharmaceutical Research and Manufacturers of America did not attend the ACCME meeting, Bert Spilker, MD, its senior vice president of scientific and regulatory affairs, said in an interview that there is no reason to tinker with the standards.

“Just because this document is 10 years old is no reason to take a look at it,” said Dr. Spilker. “If they cannot give examples of problems, then I would question whether anything needs to be changed.”

Dr. Spilker said he did not think drug companies inappropriately influenced CME activities. “Pitting industry against academia is totally the wrong approach,” he said. “This is not an issue of the standards need to be adjusted. This is more an issue of where physicians need more education in how to take out information that is of benefit to their patients.”