The Case
You are a rheumatologist who routinely attends local continuing medical education (CME) lectures in your field, in addition to ACR-sponsored CME lectures. A nearby hospital has regularly scheduled Grand Rounds lectures as part of their CME calendar of events. You note that a prominent rheumatologist, whom you have met several times at investigator meetings and “ad boards” involved with a specific biological agent used in the treatment of rheumatoid arthritis, will be presenting a lecture on the diagnosis and treatment of psoriatic arthritis.
You attend the lecture, and as expected, the speaker shows a slide at the beginning of the lecture disclosing any conflicts of interest. He states that he has nothing to disclose, and you are surprised. You know that several biological drugs are used in the treatment of psoriatic arthritis, and one of the Food and Drug Administration–approved options is the very same drug that sponsored the clinical trials and the “ad boards” in which both you and the speaker participate.
Clearly the speaker has a financial relationship with the company related to his participation in clinical trials and promotional programs. Although he may not do research on psoriatic arthritis, he has done research on one of the drugs being discussed. His disclosure seems disease specific, rather than drug or company specific. You now have concerns about whether or not this is truly an “unbiased” CME lecture.
Professional Guidance
Before we examine the ethics of this situation, what exactly constitutes “clear and full disclosure”? Presumably, any and all money received from industry by physicians who can then influence medical practice by either their research, opinions, or roles in decision-making bodies should be clearly and fully disclosed.
The Council on Ethical and Judicial Affairs (CEJA) of the American Medical Association provides guidance to physicians to put into practice the basic principles of transparency, independence, and accountability in the context of CME. If a “conflicted expert” is central to the success of an educational activity, then that person’s participation is permissible, but there must be adequate disclosure of any financial conflict of interest. The CEJA does not define a significant conflict of interest except to mention participating in an advisory board or speakers’ bureau as examples. The CEJA also notes that it is appropriate to disclose the “magnitude” of financial interest by disclosing in terms of a dollar range—even in terms such as between $2,500 and $5,000.
In addition, the Code of Ethics of the ACR (August, 2011) states, in part, that:
- The ACR can succeed in its mission to advance rheumatology only if each member is seen “as a credible, objective, and unbiased force whose statements, activities, and relationships are beyond reproach.”
- Since transparency is critical so that treatment recommendations can be honestly evaluated, disclosure of professionally related commercial interests that may influence clinical decision making is required in communications to colleagues.
The ACR requires that everyone in a position to control the content of CME courses presented under the auspices of ACR must disclose all relevant financial relationships with any commercial interest if they occurred in the 12 months prior to the development of the course.
The Dilemmas
This case illustrates several ethical dilemmas. First, is the speaker being deceptive or not? Is it possible that the disclosure guidelines for the CME lecture did not require disclosure in this case?
Second, should the ACR standard for disclosure apply just to ACR CME activities or to all members who present CME lectures in any venue?
Third, your knowledge of the relationship between the speaker and industry leads you to think that, for some reason, the speaker has a motive to avoid full disclosure. What, if anything, is he trying to hide, and do you have an obligation to address your concerns with the speaker or the hospital sponsoring the CME activity?
Finally, do your misgivings about this speaker challenge the value of CME lectures in general, or do they reflect negatively only on this hospital and/or this speaker?
What are your thoughts on or reactions to this scenario? Please send your comments or questions to [email protected], and we will publish some of your responses in a future “Ethics Forum.”
Dr. Rubin is clinical professor of medicine at Wayne State University School of Medicine and division head of rheumatology at Henry Ford Hospital, both in in Detroit.