Conflict of Interest, Disclosure, and Trial Reports

Abstract

WHEN I WAS AN ASSISTANT PROFESSOR, MY previous training had not prepared me for the unexpected attention that 2 articles, both from the same study, were to receive. One article provided evidence that abruptly stopping -blockers might increase the risk of coronary events. The other suggested that, compared with the use of high-dose diuretics, which is now no longer recommended, the use of -blockers might be associated with a lower risk of coronary events in hypertensive patients. While the news media’s coverage of the risk study was transient, the pharmaceutical industry had a more sustained interest in the other publication. My family and I were invited to a first-class resort, where I presented the results at a sponsored conference. Although I lacked both the golf skills and the sense of entitlement to make the most of the holiday, the effort did result in a publication in an industry-funded supplement. With several other scientists, I was also invited to serve as a consultant to develop a slide set about -blockers and to give a series of funded talks for the manufacturer. Young but knowledgeable, I was certain that I could help the sponsor fashion an unbiased presentation, but from the outset, I chose not to travel and give talks around the country. While scientific advice could be provided in a disinterested fashion, funded speaking engagements seemed to me to have the potential to cross the line into the arena of marketing. At a meeting set up by a communications company to produce the slide set, I participated with representatives from the manufacturer and senior scientists whose work I knew well. Over lunch, we chatted about interests, projects, and families. The preliminary outline for the slide set contained a number of traditional topics, such as the effects of -blockers on blood pressure or anginal symptoms. As we developed content, I soon found myself advocating the use of studies that featured the manufacturer’s product as the best illustrations. My experiences at the pleasant luncheon and in the scientific discussions made me feel as if the other consultants and I had a kind of social duty to reciprocate both the kindness and the investment made by the sponsor in the slide set. Accordingly, I spoke out about the importance of using some of the sponsor’s studies as examples. At the time, I failed to recognize that this sense of duty might be in conflict with an intention to create an unbiased presentation about the risks and benefits of -blockers. It turns out that I am not alone. In a study of medical residents, 61% were confident that drug company promotions did not influence their practice, but only 16% were equally confident that their colleagues were not influenced by those same drug company promotions. How is this possible? Selfinterest simply distorts the way we render judgments about ourselves. As Katz and colleagues describe the problem, “When a gift or gesture of any size is bestowed, it imposes on the recipient a sense of indebtedness. The obligation to directly reciprocate, whether or not the recipient is directly conscious of it, tends to influence behavior. . . . Feelings of obligation are not related to the size of the gift.” Precisely my experience. Other interesting social science insights have emerged from the field of behavioral economics. For instance, Ariely conducted a series of experiments in which study participants were rewarded financially for the number of correct answers on tests. The experiments were designed so that cheating was possible. On the basis of the results of these experiments, Ariely concluded that many individuals cheat when they have a chance, but only by a small amount; they know that they are overclaiming the number of correct answers; but this low-level cheating does not cause them to view themselves as dishonest. When I recently used a university envelope to mail a letter to my daughter, I too did not view myself as dishonest, perhaps because I used my own postage stamp. These minor dilemmas fail to cross key moral boundaries with the result that they are not experienced as a conscious and deliberate choice between the size of the reward and the potential cost to credibility or reputation. The frequently expressed view that industry gifts or consulting fees are too small to influence behavior simply misses the point that, regardless of their size, they influence behavior, and a self-serving bias distorts the way that individuals perceive themselves. As a result, industry gifts, fees, or funding have become culturally acceptable even though service in a profession does not itself provide immunity from po-