Standards for Commercial Support Of CME Get Stricter

Rules governing the commercial support for continuing medical education (CME) and disclosure of conflicts of interest are tightening.

The Accreditation Council for Continuing Medical Education (ACCME) has issued “Updated Standards for Commercial Support of Continuing Medical Education” requiring all persons who are in a position to control the content of an educational activity to disclose all relevant financial relationships within the previous 12 months. The new standards also require providers of CME to implement a mechanism to identify and resolve all conflicts of interest prior to the educational activity.

The updated standards are significantly stricter than previous rules approved by the ACCME in 1992, which required only disclosure of conflict of interest—not a specific mechanism for resolving conflicts—and did not extend to all those who exert any control over the content of CME activities.

In comments on the new standards, the ACCME states on its Web site that“ it does not accept disclosures or disclaimers as mechanisms that resolve conflicts of interest.... Formal CME activities are now being held to a higher standard than simple disclosure in assuring independence from commercial influences.”

As an instance of this new, higher standard, the new regulations state,“ An individual who refuses to disclose relevant financial relationships will be disqualified from being a planning committee member, a teacher, or an author of CME and cannot have control of, or responsibility for, the development, management, presentation, or evaluation of the CME activity.”

In contrast, under the old standards, participants in a CME program were simply notified (verbally or in writing) when a faculty member “refused to disclose.”

APA Ahead of Game

The strictness of the new standards has raised some concerns that they might potentially stifle CME activities. But leaders of APA, which offers a host of CME activities at annual meetings and through other venues and is accredited by the ACCME, noted that among the mechanisms for resolving conflicts of interest that the ACCME has said are acceptable are “peer review” and reference to “best available evidence.”

In this way, it would appear that APA already has in place some of the mechanisms necessary to meet the new ACCME criteria for resolution of conflicts of interest. Oversight of APA's spring and fall annual meetings by large scientific program committees that utilize peer review of submissions, for example, may fulfill at least part of the ACCME requirement.

However, uncertainties remain such as what kind of mechanism must be implemented for programs jointly sponsored with a district branch or for one developed for APA's CME Web site. APA staff said that development and codification of an exact mechanism to resolve conflicts of interest, for these meetings and for all other APA educational activities, may take several months.

“What is good about the new standards is the fact that it makes an organization like APA, and anyone else who is putting on CME, think very carefully about what are and are not conflicts of interest,” said Philip Muskin, M.D., a member of APA's Committee on CME/Lifelong Learning and the Scientific Program Committee and a speaker at commercially supported symposia.

Muskin said APA has been rigorous in doing precisely that long before the new standards were issued and has “set the standard” for implementing guidelines and policies on conflict of interest. He also that the new standards could, depending on how they are interpreted, make it significantly harder to attract highly qualified speakers.

Muskin defended the use of industry-supported symposia at APA's annual meetings. “People complain that the dog is being wagged by the tail,” he said, “but in 15 years on the Scientific Program Committee I have never seen the pharmaceutical tail wag the APA dog. We patrol what the companies do, and if they step out of line they hear from us.”

Eliminating Commercial Influence

The updated standards appear to be a response to concerns from all quarters of the biomedical community about the purity of research and medical information and the independence from commercial bias of those who disseminate that information.

“For the sake and safety of patients, the continuing medical education in which physicians participate must be free of commercial bias,” said ACCME Chief Executive Murray Kopelow, M.D., in a statement.“ The ACCME believes that eliminating the influence of commercial interests in the planning and production of CME is the way to accomplish this, and these sentiments are reflected in the ACCME's 2004 `Updated Standards for Commercial Support.' These updated [standards] continue to require accredited providers to take responsibility for all aspects of the planning and implementation of their CME activities—including making decisions about content, faculty, and management of funds. In addition, they now require providers to have a mechanism in place to identify and resolve conflicts of interest in CME.”

The updated standards became effective upon approval by ACCME in September 2004, but accredited providers have until May to implement the standards and develop CME activities that comply with all aspects of the standards. However, the ACCME has also stated that it is aware there will be some overlap between use of the old and new standards because of CME activities for which planning began well before the May deadline, even though the activity itself is presented after that date.

Accredited providers due for reaccreditation decisions on or after November 2006 will be expected to make available for review a full year of activities that demonstrate compliance with the updated standards. And CME providers seeking initial accreditation after June must demonstrate mechanisms for compliance with the standards at the time of their accreditation review.

“Updated Standards for Commercial Support of Continuing Medical Education” are posted online at<www.accme.org/dir_docs/doc_upload/68b2902a-fb73-44d1-8725-80a1504e520c_uploaddocument.pdf>. Questions about the standards are posted at<http://preprod.cms.accme.duodesign.com/index.cfm/fa/faq.home/Faq.cfm>.▪