This month marks the deadline for groups that offer continuing medical education courses to begin implementing new CME standards designed to eliminate undue outside influence on course content.
Approved by the Accreditation Council for Continuing Medical Education last fall, the new Standards for Commercial Support are designed to head off CME bias by requiring a rigorous examination of the financial relationships speakers have with pharmaceutical and medical device companies.
The standards can be considered analogous to new guidelines on the supplier side, including the pharma-code standards set in 2003 for the marketing of pharmaceutical products, and last year's AdvaMed code of ethics that govern the relationship between medical device manufacturers and physicians.
"This has caused us to revamp our planning process," noted Erin Schwarz, manager of programs and education for the Society of American Gastrointestinal Endoscopic Surgeons, based in Los Angeles, of the new CME standards.
"It requires more paperwork and follow-up, and also additional reviews of session content in advance of a meeting," Schwarz said. "But it's actually an extension of trying to provide continuing education that is of the highest quality and best scientific integrity."
The new standards are driven by an essential ingredient: requiring of virtually everyone who touches a conference full disclosure of any connection with suppliers.
That could include session presenters, planners, planning committee members, association officers, relatives of the above (parents, spouses, children) and perhaps even their relatives.
While the standards mandate scrutiny for bias, it leaves the methodology unspecified, with associations taking various approaches to the challenge.
"For example, we haven't had a written policy on speaker honoraria and expenses, but we'll have one soon," said William Hering, director of CME and Programs for the American Academy of Ophthalmology, in San Francisco.
"Why? Because you need to know what people are being paid and the source," Hering said. "A pharmaceutical company, for instance, may decide to support a particular speaker with an outrageous honorarium."
Some CME directors had initial misgivings about the new standards when they were first promulgated in September. There was suspicion, for example, that the guidelines would ban any speaker with any financial connection to a supplier. Since many physicians have consultancy arrangements, that was seen as unreasonable.
But the standards' purposely vague solutions also trouble some CME directors. For example, one item specifies, "The [CME] provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners."
"But the standards don't identify what a conflict of interest is," Hering noted. "It defines a relevant relationship with a supplier as anything in the past 12 months that creates a conflict of interest, but not what a conflict of interest might be."
Hering said his organization will not bar speakers that have commercial relationships with suppliers "because they know the most about the topics."
"Our approach will be, first, to disclose everyone's financial relationships to everyone, and second, to have extensive peer review of the CME content, which we do anyway. And lastly, after the fact, we'll ask in every CME activity evaluation if any bias was detected."
Some severe solutions organizations are imposing require presenters to get rid of supplier-company shares of stock, and to refrain from making drug or device recommendations.
"But if one doctor who is a world expert says he uses a particular instrument in a particular case, that's what you want to know," Hering said. "I also want to know if he's being paid."
Another strategy is to have a moderator be on the lookout for any comments from a speaker than may be biased, noted Melinda Steele, director of CME at Texas Tech University Health Sciences Center, in Lubbock.
"If so, the moderator might intervene and lead a discussion on alternate viewpoints or products," she said.
A tool kit on the new standards is available at www.accme.org.
Contact Christopher Hosford at [email protected]