Bioethics journals have lagged behind medical and science journals in exploring the threat of conflict of interest (COI) to the integrity of publications. Some recent discussions of COI that have occurred in the bioethics literature are reviewed. Discussions of what has been termed the ?Healy affair? unintentionally demonstrate that the direct and indirect influence of undisclosed COI may come from those who call for protection from the undue influence of industry. Paradoxically, the nature and tone of current discussions may serve (...) to dull sensitivities to what is indeed a serious set of issues facing bioethics. Some proposals are presented to address COI and other challenges to the integrity of bioethics and its journals. COI is too important a topic to be left to ideologues, and there is no substitute for readers' caution and skepticism as tools in dealing with the full range of biases that exist in published papers. (shrink)

The study examines the attitudes among physicians regarding acceptance of gifts, sponsorships, and drug samples in response to marketing efforts of pharmaceutical companies in India. The research also attempts to study physicians’ perceptions of the Medical Council of India (MCI) guidelines on the code of conduct for pharmaceutical marketing practices and the influence of these guidelines on physicians’ actions. A structured questionnaire was developed for collecting primary data regarding exposure of physicians to promotional tools and physicians’ attitudes and practices with (...) regard to various professional ethical issues. One thousand physicians from private and government hospitals located in a metropolitan area were approached personally or through email for getting the questionnaire filled. A total of 189 completed and usable questionnaires could be obtained which is a response rate of approximately 20 %. Respondents in the study indicate being offered samples, sponsorship, and gifts by pharmaceutical companies with a frequency of at least once a month. Thus, many pharmaceutical firms are not following the code of conduct issued by the Department of Pharmaceuticals, Govt. of India. Further, though almost all physicians report being aware of the guidelines issued by the MCI, yet as many as 69 % of the sample admitted to be accepting gifts and sponsorships offered by the pharmaceutical firms. Educational programs were found to be influencing physician prescription behavior to a greater extent when compared with gifts. Frequency of offers made for gifts and sponsorships were found to be dependent upon physicians’ practice (number of prescriptions written) and the type of hospital they are associated with (private or government). The study focuses on sensitive yet critical ethical issues related to the promotional practices of pharmaceutical firms in India and physicians’ responses with regard to these promotional practices in the context of the guidelines of the Medical Council of India and the Department of Pharmaceuticals. (shrink)

No discussion of academic freedom, research integrity, and patient safety could begin with a more disquieting pair of case studies than those of Nancy Olivieri and David Healy. The cumulative impact of the Olivieri and Healy affairs has caused serious self examination within the biomedical research community. The first part of the essay analyses these recent academic scandals. The two case studies are then placed in their historical context—that context being the transformation of the norms of science through increasingly close (...) ties between research universities and the corporate world. After a literature survey of the ways in which corporate sponsorship has biased the results of clinical drug trials, two different strategies to mitigate this problem are identified and assessed: a regulatory approach, which focuses on managing risks associated with industry funding of university research, and a more radical approach, the sequestration thesis, which counsels the outright elimination of corporate sponsorship. The reformist approach is criticised and the radical approach defended. (shrink)

When the University of Toronto withdrew a contract it held with me in December 2000, it initiated a sequence of events that led to a public letter to the University from senior figures in the world psychopharmacology community protesting against the infringement of academic freedom involved and a first ever legal action, undertaked by this author, seeking redress for a violation of academic freedom. The issues of academic freedom surrounding this case have been intertwined with a debate about the possibility (...) that the selective serotonin reuptake inhibitor (SSRI) group of antidepressants have the potential to trigger suicidality in a subgroup of patients. Whether the SSRIs do trigger suicidality or not, exploration of this issue has given rise to a number of worrying sets of observations. First, in my view, there is evidence that pharmaceutical companies have miscoded raw data on suicidal acts and suicidal ideation. Second, this author also maintains that there is a growing body of examples of ghostwriting of articles in the therapeutics domain. Many of the tensions evident in this case, therefore, can be linked to company abilities to keep clinical trial data out of the public domain — this is the point at which the pharmaceutical python gets a grip on academia. (shrink)

Randomization is the “gold standard” design for clinical research trials and is accepted as the best way to reduce bias. Although some controversy remains over this matter, we believe equipoise is the fundamental ethical requirement for conducting a randomized clinical trial. Despite much attention to the ethics of randomization, the moral psychology of this study design has not been explored. This article analyzes the ethical tensions that arise from conducting these studies and examines the moral psychology of this design from (...) the perspectives of physician-investigators and patient-subjects. We conclude with a discussion of the practical implications of this analysis. (shrink)