Tougher CME conflict-of-interest rules take effect

Physicians attending continuing medical education events can expect to hear content that contains less commercial bias than previous sessions did, according to CME leaders.

As of May 1, new CME projects must comply with revised Accreditation Council for Continuing Medical Education standards that increase the level of scrutiny.

Physician faculty teaching at CME events and those involved in planning content will likely see the biggest changes. They'll no longer be able to disclose only their relevant financial relationships. Physicians will have to prove what they're doing is free from any commercial influence.

Lynn Smaha, MD, PhD, past president of the American Heart Assn., said tightening controls on commercial influence is vital. "Personally, as a clinical cardiologist, I want to practice evidence-based medicine, and I want to know the evidence is pure and not influenced by drug companies or device manufacturers."

It's also vital to the AHA, Dr. Smaha said. "The American Heart Assn. takes [ACCME standards] very seriously. It can never be seen as biased."

The new rules were announced in September 2004 and initially left CME providers fearful that they wouldn't be able to use top researchers as presenters because their research is often funded by pharmaceutical or device manufacturers.

"The gravest areas of concern flow from the fact that the ACCME has defined any financial relationship with a commercial interest as a conflict, and that conflict must be resolved," said Bruce Bellande, PhD, executive director of the Alliance for CME.

Specialty societies were particularly concerned because they rely heavily on a small pool of top researchers and clinicians who receive industry funding. But as the rules are set to go into place, those fears have been addressed, Dr. Bellande said.

Kate Regnier, ACCME deputy CEO, agreed. "With anything new there is some anxiety and mixed emotions. We've worked with providers since then to clarify the updated standards and to discuss ways to resolve them."

Educators said a critical step was understanding that in many situations peer review could resolve commercial conflicts.

Finding solutions

How CME providers are resolving these conflicts varies. For the medical specialty societies with peer review committees already set up to evaluate scientific papers, they're adding in reviews of speakers' material when appropriate. Speakers are asked to use only the best available evidence and to avoid using brand names.

R. Van Harrison, PhD, director of continuing medical education at the University of Michigan Medical School, said he wants to keep the effort invested in resolving conflicts of interest to a level that's commensurate with the circumstances. For local presenters, it may be enough to have a quick talk with them to make sure there's no bias in the presentation.

Barbara Huffman, manager of CME for Carle Foundation Hospital in Urbana, Ill., listed a number of ideas for neutralizing conflicts of interest. For example, an ethics committee could be created to decide on a case-by-case basis which financial relationships pose a problem and how they should be resolved. In some cases an ombudsman could work with people one-on-one to point out inherent biases and suggest ways to avoid them. She's also considering creating a video for CME planners and speakers based on research showing how bias creeps in and how people can assess their own inherent biases.

Another idea is to plant a medical observer in the audience. This person would give immediate feedback to the audience or to the speaker's boss, rating bias in the presentation.

Walter J. McDonald, MD, executive vice president of the Council of Medical Specialty Societies, said his organization is comfortable with the revised rules.

"For the most part our member societies are satisfied," he said. "When [the standards] first came out we were unhappy ... and we pushed hard for an interpretation that would not prohibit using the best and the brightest."