Karen Overstreet has co-founded a new association for medical communications companies.
“Instead of pointing fingers at each other, let's sit down together and work out reasonable solutions and strategies.” So says Barbara Barnes, MD, president, Society for Academic CME (SACME), and associate dean, CME, University of Pittsburgh, responding to yet another attack on CME's credibility.
In his article, “Separating Continuing Medical Education from Pharmaceutical,” which appeared in the April 18, 2001, issue of The Journal of the American Medical Association, Arnold S. Relman, MD, professor emeritus of medicine and of social medicine, Harvard Medical School, declared that industry-supported CME is no more than a marketing tool for pharmaceutical companies. With the collusion of accredited CME providers, Relman charges, pharmaceutical companies influence program content and , eroding the independence and integrity of physician education.
His two main recommendations are that industry support of CME be limited to renting exhibit booths, and that only traditional CME providers, such as medical institutions and associations, should be eligible for accreditation by the Accreditation Council for CME ().
Relations between accredited CME providers and industry supporters are governed by the Accreditation Council for CME's Essentials and Standards for Commercial Support. These rules allow industry to provide unrestricted educational grants for CME as long as control of the programs remains with the provider. As for accreditation status, the ACCME has always taken a similarly inclusive stance: Any medical education organization that meets the ACCME criteria — even a pharmaceutical company — is eligible for accreditation. And though changes are in the works to address growing concerns about ethical violations, the fundamental tenets of industry/provider collaboration will likely remain the same, says Murray Kopelow, MD, executive director, ACCME.
White Paper or White Elephant?
Relman's article refueled ongoing controversies within the CME community. Several years ago, nine SACME members issued a White Paper calling on the ACCME to strip MECCs (medical communications and education companies) and other nontraditional providers of their accreditation. The White Paper ignited contentious debate; in the end the signatories withdrew the resolution before putting it before SACME members for a vote. And the White Paper is not going to be resuscitated, says Barnes. Instead, SACME is concentrating on how to improve CME's effectiveness.
And that means continuing to work with industry. Forty percent of medical schools' CME funding comes from industry, according to the ACCME's 1999 annual report. “The availability of commercial support enables us to do many activities we would not ordinarily be able to do,” says Barnes. “It is critically important to inform physicians about new research findings. In many cases, the most up-to-date information is held by commercial entities. It's a challenge for CME offices to assure that the relationship does not alter [our] level of control over content. Everyone is concerned about assuring all of our activities are balanced.”
Show Me the Data
As for nontraditional providers' relations to industry: Relman's contention that medical communications companies are the “hired agents” of pharmaceutical companies is countered by ACCME data, according to Kopelow. The numbers of complaints about possible violations are proportionate to the provider groups' representation within ACCME, he says. “Most providers are specialty societies and medical schools so therefore most complaints and inquiries are about them.”
In fact, MECCs are doing better in some areas. Twelve nonacademic providers, who identified themselves as communications companies, education companies, or “other” under ACCME categories, have gone through the ACCME's new reaccreditation system, says Kopelow. Seventeen percent of them received, compared to 3 percent of the remaining 100 providers reaccredited under the new system.
Nevertheless, nontraditional providers do receive a disproportionate percentage of commercial support for CME. According to the ACCME's 1999 annual report, communications companies represented four percent of accredited providers, yet they received 18 percent of the commercial support.
The persistent concerns about the independence of for-profit providers' CME are prompting changes in the rules. The ACCME recently instituted a firewall policy, a specific set of guidelines for FDA-regulated entities. The draft version would have included communications companies. However the final version only applies to FDA-regulated providers, meaning drug and device companies. The definition was narrowed, Kopelow says, to keep the policy as unrestrictive as possible.
However, the ACCME is now considering adding a firewall-like provision about “agency relationships.” This would apply if a company had a fiduciary relationship with a drug company. For example, Kopelow explains, “if an education company's only job is to put on education for a pharmaceutical company, what is the difference between those two firms?” In those cases, he says, it might be reasonable to consider both organizations as the commercial supporter.
New Bias Busters
One of the firewall rules is that providers must ask attendees and faculty if they detected commercial bias in the program; if so, providers must take steps to prevent bias in future programs. Asked why that rule shouldn't apply to all providers, Kopelow answers, “There isn't a good reason why it's not a requirement of all CME providers.”
In fact, the ACCME is now working with the American College of Physicians/American Society of Internal Medicine and the American Psychiatric Association to develop standardized procedures for identifying bias in programs.
Further, the ACCME is reviewing the Standards for Commercial Support. It has solicited recommendations for changes from accredited providers and other organizations, and will hold a hearing July 11 in Chicago. The ACCME hopes to have a report ready for providers' comments by the end of the year, says Kopelow.