Emily Anderson

In lieu of an abstract, here is a brief excerpt of the content:Re-examining Empirical Data on Conflicts of Interest Through the Lens of Personal NarrativesEmily E. Anderson and Elena M. KrausIntroductionThe personal stories submitted by physicians and researchers for this symposium add much–needed dimension to conversations on conflicts of interest in medicine and research. Narratives from individuals living with conflicts of interest can serve as a unique lens through which to consider psychological and economic theories and survey data on physician and patient views. In our reading of these personal narratives, we identified four primary themes that will serve as springboards for our commentary. We aim to triangulate clusters of meaning drawn from the narratives with relevant data from published empirical studies and identify gaps in knowledge where more research is needed. These themes are: the unique environments of medicine and research; weighing the potential benefits of conflicts of interest against the risks; conflict of interest management; and the roles and responsibilities of diverse stakeholder groups.The Unique Challenges of the Medical and Research EnvironmentsThe reflections of the narrative authors draw attention to many of the unique environmental aspects of medicine and medical research that make physicians and researchers especially vulnerable to conflicts of interest. Conflicts of interest may be more ubiquitous in medicine than in any other industry (Kassirer, 2006). As the narratives demonstrate, conflicts of interest emerge across a range of health care delivery and research activities. Surveys have shown that 94 percent of physicians have some kind of relationship with industry (Campbell, Gruen, Mountford, et al., 2007). There is also evidence that physician interactions with medical industry begin early and are a regular part of a physician’s professional practice along the career continuum (Wazana, 2000).Medicine as a profession is distinct from banking or law. It is often said that medicine is an art; in treating patients, creative individualized solutions and gut instinct are as (if not more) important than the application of scientific knowledge. Uncertainty surrounds medical decision making. There is limited precision with respect to diagnoses and prognoses, limited data regarding the effectiveness of many treatments, and a range of patient values and preferences. Because of this uncertainty, rules about practice standards, especially with respect to avoidance and management of conflicts of interest, cannot be as explicit as they are in law or business. As demonstrated by the story presented by Sal Cruz–Flores, research and practice often intersect. And, there is no system in greater need of reform—and no system about which there are more divergent opinions as to what shape that reform should take—than the United States health care [End Page 91] system. The narratives of Tony Mikulec, Govind Nagaldinne, and David M. Zientek demonstrate how various aspects of the structure of healthcare service provision and third–party payer arrangements have the potential to harm patients. Conflicts of interest comprise more than relationships with pharmaceutical and medical device manufacturers.The narratives of Laura Jean Bierut and David M. Zientek also discuss examples of conflicts of interest that arise from factors beyond relationships with industry or the direct potential for financial gain. This may be somewhat unique to the medical milieu. Non-financial conflicts such as a desire for the prestige bestowed upon scientists who make key discoveries, a requirement to publish for tenure and promotion, the need to maintain one’s license or other privileges, or simply the pressure of a competitive environment can influence physician and researcher behavior. As noted by Bierut, more research on how to identify and manage non-financial conflicts is needed.The Potential Benefits and Harms of Conflicts of InterestConflicts of interest are usually presented in a negative light, particularly those that involve physician relationships with the pharmaceutical industry. To “have a conflict of interest” is to be in a situation or role where there is potential for personal interests to be prioritized over professional responsibilities. However, in terms of public perception, it seems that conflicts of interest have become almost synonymous with wrongdoing. Perhaps this is due to the barrage of media reports during the last decade on significant harms caused by financial conflicts of interest in business, journalism, and sports as well as in medicine (Steinbrook, 2004). Amidst...

Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s.