The revised Standards state that the current disclosure rules, which stipulate thatand sponsors disclose their significant financial interests and other relationships with pharma firms, may not always be enough to ensure the separation of promotion from education. Under the new rules, if people or organizations disclose that they have a conflict of interest with a commercial interest (such as a drug firm), they should not be allowed to control the content of CME—in other words, they should be excluded from serving as a planning committee member, manager, or teacher. Conflict of interest is defined as a relationship “that may be perceived by the to create a sense of duty or loyalty” to the commercial interest, and as creating “a conflict between the interest of the individual and the interests of the public or learners.”
The new Standards “accommodate every one of our provider types,” says Murray Kopelow, MD, ACCME Chief Executive, “but it is going to require some providers to change how they do business.” What does that all mean? Here’s a hypothetical example: “An accredited communication company, that is part of a largerfirm that is part of a commercial interest, puts on CME in the content area in which they have a commercial interest. That very likely would be perceived as a conflict of interest,” explains Norman Kahn Jr., MD, chair of the ACCME’s task force on the Standards. Kahn, who is also vice president, science and education, American Academy of Family Physicians, Leawood, Kan., says that the situation is different in the case of an independent communication company that has numerous clients and funding sources, and where everybody adequately discloses their relationships. In that situation, there would not necessarily be a conflict of interest.
If a provider appears to have a conflict of interest, it will have the opportunity to demonstrate to the ACCME that because of its corporate bylaws, firewalls, and organizational structure, it is adequately separating promotion from education, adds Kopelow.
But what about faculty members who own stock in pharma companies? Who serve on pharma speakers bureaus? It depends, says Kahn. “There’s no black and white example. Take an extreme case: Someone is trained by a drug firm as a promotional speaker, is paid a lot quite regularly, and has a reputation as being a promotional speaker—that would possibly be a situation where the speaker would be viewed as an agent of that company. In contrast, if somebody is on the speakers bureaus of many companies and is predominantly a CME speaker, not a promotional speaker—in that case, disclosure could be enough.”
“The ACCME is empowering providers to make decisions about their teachers and authors on the basis of the disclosed information. That’s the key and fundamental difference between the new and the old Standards,” says Kopelow. "You can say to the drug company, ‘I’m sorry, but that person cannot speak at this event even though you are the commercial supporter because of her interest in your firm.’”
The goal of the new Standards is to protect CME’s safe harbor from regulation by the FDA and the Office of the Inspector General, says Kahn. If the CME community doesn’t succeed at continuing to regulate itself, demonstrating that it can separate promotion from education, the result will likely be “terrible media attention and government regulation,” he cautions.
For more information, watch for the January/February issue of.