Where Are the Ethics Police?
The area of ethical relations - or rather, unethical relations - between pharmaceutical companies, CME providers, and physicians was the chief topic of concern and controversy at the American Medical Association's 11th Annual Conference on CME Provider/Industry Relations held in September - and one of the most outspoken participants was Melinda Steele, director of CME, Texas Tech University Health Sciences Center in Lubbock. Steele, who has been involved in CME since 1992, argued that CME providers are put in the untenable position of trying to persuade physicians to abide by the AMA's Ethical Opinion on Gifts to Physicians from Industry - when the AMA has no policy for enforcing the rules or penalizing members who violate them. In a telephone interview following the conference, we asked Steele what she thinks needs to be done.
Q: How are CME providers put on the spot when attempting to enforce the Ethical Opinion?
A: CME providers continue to be the only ones to suffer any consequences of opinions or policies targeted at physicians and the pharmaceutical industry. [If ethical policies are violated during a CME activity, the CME provider is held responsible by the Accreditation Council for CME.] I think most of us (CME Providers) are weary of always being the bad guys or the ones who have to continually say "No, you can't do that because..." That creates friction with program directors who don't see [their ideas] as a problem even when we pull out the Opinion.
Q: Is the Ethical Opinion a realistic set of guidelines for physicians in today's health care environment?
A: I don't have a problem with the intent or philosophy of the Opinion. The guidelines should be taken seriously - especially in today's health care environment. [But] some of the physicians I work with just shake their heads and chuckle in disbelief that we take it so seriously. For the most part, I believe the physicians I work with are ethical in their behavior, but they just do not see this Opinion as applicable to them nor do they see anything wrong with the implied behaviors.
Some physicians even think that it only applies to AMA members. It is my understanding that the Ethical Opinion is supposed to apply in all situations, not just CME - but where is the penalty or enforcement in non-CME situations?
Another thing we run into: In the olden days physicians were expected to join the AMA. That is not the case anymore. Young physicians who are not AMA members are not even aware of the Ethical Opinion.
Q: What changes should be made to the Opinion?
A: There should be clearer definitions of what is acceptable practice. At one of the [AMA conference] sessions, the issue of golf [at CME events] came up. Most CME providers think [golf events] are not an acceptable incentive to offer. But the AMA representatives were most adamant in their defense of [golf] as acceptable. Yet when someone asked about theater tickets or football tickets, [AMA representatives said those] were not acceptable. There is no consensus between CME providers, industry reps, and AMA reps. The Opinion says it is OK for conferenceto accept reasonable honoraria. Well, what's reasonable? Some physicians are paid as little as $200 and are terrific speakers. Others demand $10,000.
Q: How should ethical guidelines be enforced?
A: Until there's a penalty [for violating guidelines], pharmaceutical companies will still offer [incentives] and physicians will still accept everything that is offered. A lot of physicians I talk to say, "I'm not influenced by this." If the AMA really expects compliance, it has to educate physicians so they are able to say "no."
Q: What role should CME providers' play in helping physicians and industry adhere to guidelines?
A: Physicians and pharmaceutical companies need education. CME providers could be part of that process - education is what we do best. In Texas, the State Board of Medical Examiners requires all physicians to have one hour of CME on ethics or professional responsibility for relicensure. We could offer activities that address the Ethical Opinion and its implications for physicians.