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Academy News: September 2005 Conflict of interest: FDA members allowed to vote on future of COX-2 inhibitors A new automobile, the Zoomarosa, was recently released onto the market. After several months of being available, authorities started noticing that the Zoomarosa was involved in a significant number of car accidents. It was not clear if there was a problem with the Zoomarosa, but most of the accidents occurred because the car was driven at extremely high speeds. To decide whether the Zoomarosa should be pulled off the market or not, the National Transportation Committee (NTC) convened a panel of outside experts. The experts were not supposed to have ties to the automobile industry, but nonetheless, of the 30 panel members, 10 either had significant stock holdings or were consultants for the automobile industry. The public was told that some of the panel members had potential conflicts, but that the NTC had determined that these were not material conflicts, and were unrelated to the discourse at hand. Perhaps it is not surprising that three days later the newspapers reported that the NTC advisory panel had recommended that the Zoomarosa remain on the market, because the accidents were “clearly a result of fast drivers being attracted to the Zoomarosa’s sleek design.” Sounds a bit fanciful doesn’t it? Well, it may be that we don’t have a Zoomarosa on our roads, but the importance of identifying and dealing with conflict of interest remains. As a matter of fact, the hypothetical story discussed above is very similar to a real-life occurrence at the Food and Drug Administration (FDA).(1) Apparently at a meeting to discuss the future of COX-2 inhibitors, 10 of 32 voting panel members had “financial associations with the manufacturers of COX-2 inhibitors, such as the receipt of speaking or consulting fees or research support.”(1) According to a report by Robert Steinbrook, MD, in the New England Journal of Medicine, these apparently conflicted members provided the votes to allow COX-2 inhibitors to remain on the market.(1) Although the FDA has provisions in place to prevent individuals with conflicts from serving on advisory committees (or serving in a restricted role), it also has the ability to issue waivers to allow conflicted individuals to participate in the panels. In this case, it appears that waivers were provided, and the FDA determined that because “issues of broad applicability” were being discussed and due to the “general nature of the discussions”, the “potential conflicts [were] mitigated.”(1) While, as the chair of the meeting said, the FDA may have committed a “judgment error” by issuing the waivers, the larger concern is that the public was not told of the relevant conflicts, which the FDA had deemed “mitigated.”(1) Steinbrook’s article goes on to detail a second episode where the FDA disclosure system seemed to have failed. He then discusses potential ways to improve the FDA’s system. However, I would like to focus on the reason for disclosure and to argue for more openness in our conflict-of-interest disclosures. According to the AMA Code of Ethics, “under no circumstances may physicians place their own financial interests above the welfare of their patients.”(2) This straightforward statement becomes complicated in its interpretation. It does not say that physicians are forbidden from financial gain through interactions with other aspects of the medical system, as long as it does not jeopardize “the welfare of their patients.” In fact, in our current medical system, it is more likely that almost every physician has had a potentially conflicting interaction with industry than not. The critical component is to provide daylight, disclosure of the conflicts, real and/or perceived. This allows for the patient (or public in the case of the FDA) to make a judgment as to whether the individual is truly conflicted or not. Of course, disclosure is wonderful when the recipient can decide to ignore the advice from the conflicted person, but what happens when the conflicted person is part of a panel that will impose its views (conflicted or not) on the rest of society? This is a much more difficult issue. It is unlikely that enough truly non-conflicted experts could be found to form the advisory panels. Steinbrook argues for a more reasonable alternative: publish the names and background information in the Federal Register and on the web several weeks before the panel hearings. This would “give the public several weeks to comment” on the experts and their potential conflicts.(1) If we return to our vignette, it would have been beneficial if the NTC had provided the public with a list of potential committee members and their financial arrangements with the automobile industry. Perhaps the media would have noted on the fact that 30% of the committee members were receiving remuneration from the automobile industry. As a result of the public outcry, the NTC might have made these members non-voting, or even excluded them from the hearing altogether. Either way, the public would have been given the opportunity to scrutinize the conflicts before the committee meeting and not months after the committee’s decision had been made. References 2. Opinion 8.03. Conflicts of interest: guidelines. Code of Medical Ethics: Current Opinions with Annotations. American Medical Association. Council on Ethical and Judicial Affairs. 2002. p. 165. The AAAAI Ethics/Conflict of Interest Committee provides these discussions as a way to open a dialogue on the various ethical issues that confront our specialty on a daily basis. These issues are often quite complex and do not have simple “right” or “wrong” solutions. The articles are meant as a way to highlight the various issues that are involved in these ethical dilemmas, they should not be viewed as the AAAAI Ethics/Conflict of Interest Committee or the AAAAI’s particular stance on an issue.
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