Concerns over conflicts of interest in academic research and medical practice continue to provoke a great deal of discussion. What is most obvious in this discourse is that when COIs are declared, or perceived to exist in others, there is a focus on both the descriptive question of whether there is a COI and, subsequently, the normative question of whether it is good, bad or neutral. We contend, however, that in addition to the descriptive and normative, COI declarations and accusations (...) can be understood as performatives. In this article, we apply J.L. Austin’s performative speech-act theory to COI discourses and illustrate how this works using a contemporary case study of COI in biomedical publishing. We argue that using Austin’s theory of performative speech-acts serves to highlight the social arrangements and role of authorities in COI discourse and so provides a rich framework to examine declarations, accusations and judgements of COI that often arise in the context of biomedical research and practice. (shrink)

The welfare and protection of human subjects is critical to the integrity of clinical investigation and research. Institutional review boards were thus set up to be impartial reviewers of research protocols in clinical research. Their main role is to stand between the investigator and her human subjects in order to ensure that the welfare of human subjects are protected. While there is much literature on the conflicts of interest faced by investigators and researchers in clinical investigations, an area that is (...) less explored is CIs that may affect members of IRBs during the institutional ethics review of clinical investigations. This article examines the notion of CIs in clinical research and attempts to develop a framework for a clearer and more balanced approach to identifying CIs that may influence members of IRBs and impede their independence. It will also apply the proposed framework to demonstrate how IRBs possess, or at least may appear to possess, forms of financial CIs and non-financial CIs. The proper identification and management of these CIs is critical to preserving the integrity of clinical investigations and achieving the primary aim of human subjects protection. (shrink)

Medical educators invoke professionalism as a core competency in curricula. This paper criticizes classic definitions. It also identifies some negative traits of medicine as a profession. The call to professionalism is naive nostalgia. Straightforward didactics in professionalism cannot do the desired work in medical education. The most we can say is that students should adopt the good aspects of professionalism and the profession should stop being some of what it has been. This is a platitude. If the notion is to (...) be more than shallow, each student and practitioner will have to engage in much dialogue, reflection and refinement over many years. (shrink)

The primary claim of this paper is that intellectual conflicts of interest (COIs) exist but are of lower ethical priority than COIs flowing from relationships between health professionals and commercial industry characterized by financial exchange. The paper begins by defining intellectual COIs and framing them in the context of scholarship on non-financial COIs. However, the paper explains that the crucial distinction is not between financial and non-financial COIs but is rather between motivations for bias that flow from relationships and those (...) that do not. While commitments to particular ideas or perspectives can cause all manner of cognitive bias, that fact does not justify denying the enormous power that relationships featuring pecuniary gain have on professional behaviour in term of care, policy, or both. Sufficient reason exists to take both intellectual COIs and financial COIs seriously, but this paper demonstrates why the latter is of higher ethical priority. Multiple reasons will be provided, but the primary rationale grounding the claim is that intellectual COIs may provide reasons to suspect cognitive bias but they do not typically involve a loss of trust in a social role. The same cannot be said for COIs flowing from relationships between health professionals and commercial industries involving financial exchange. The paper then assumes arguendo that the primary rationale is mistaken and proceeds to show why the claims that intellectual COIs are more significant than relationship-based COIs are dubious on their own merits. The final section of the paper summarizes and concludes. (shrink)

Conflict of interests in medicine are typically taken to be financial in nature: it is often assumed that a COI occurs when a healthcare practitioner’s financial interest conflicts with patients’ interests, public health interests, or professional obligations more generally. Even when non-financial COIs are acknowledged, ethical concerns are almost exclusively reserved for financial COIs. However, the notion of “interests” cannot be reduced to its financial component. Individuals in general, and medical professionals in particular, have different types of interests, many of (...) which are non-financial in nature but can still conflict with professional obligations. The debate about healthcare delivery has largely overlooked this broader notion of interests. Here, we will focus on health practitioners’ moral or religious values as particular types of personal interests involved in healthcare delivery that can generate COIs and on conscientious objection in healthcare as the expression of a particular type of COI. We argue that, in the healthcare context, the COIs generated by interests of conscience can be as ethically problematic, and therefore should be treated in the same way, as financial COIs. (shrink)

In purity and holiness I will guard my life and my art.Every physician-patient encounter is a conflict of interest. Every physician-payer encounter is also a conflict of interest.Wide-spread criticism of the pharmaceutical industry’s extravagant marketing practices and some doctors’ undignified, even appalling eagerness to stuff themselves, their pockets and their offices with the industry’s “stuff,” prompted physician groups, the drug and device industry itself to institute reforms designed better to limit industry influence on physicians.But according to Troyen Brennan and his (...) coauthors, the reforms, while reducing some of the most egregious instances of industry influence peddling and physicians’ self-debasement, were doomed fundamentally, for three reasons. First, they were based on common sense but incorrect assumptions about the mechanism of industry influence and on myths about the efficacy of disclosure as an ethical disinfectant. Second, they relied on voluntary adherence and so failed to pinpoint responsibility for monitoring compliance and enforcement. (shrink)

This article argues that positioning disclosure as a primary remedy in addressing the ethical problems posed by conflicts of interest in medicine and health is an error. Instead, bioethical resources should be devoted to the problems associated with sequestration, defined as the elimination of relationships between commercial industries and health professionals in all cases where it is remotely feasible. The argument begins by arguing that adopting Andrew Stark’s conceptual framework for COIs leads to advantages in understanding COIs and in ordering (...) priorities for intervention. The article then draws on prior work establishing that COIs are, under ordinary epidemiologic standards, properly regarded as population health hazards. This justifies attention to possible remedies, of which disclosure generates by far the most analysis. Such primacy is unwarranted given the extensive evidence suggesting that disclosure as a remedy for COIs is at best ineffective. ‘At best’ is justified because the evidence also shows that disclosure may have a perverse effect, intensifying biased behaviors. Expending significant attention on an ineffective or even deleterious intervention is unjustified and also crowds out devotion of resources to the real problems that attend sequestration. Therefore, disclosure ought to be regarded as a lower priority among possible COI interventions. (shrink)

In recent years, online direct-to-consumer pharmaceutical companies have been created as an alternative method for individuals to get prescription medications. While these companies have noble aims to provide easier, more cost-effective access to medication, the fact that these companies both issue prescriptions as well as distribute and ship medications creates multiple ethical concerns. This paper aims to explore two in particular. First, this model creates conflicts of interest for the physicians hired by these companies to write prescriptions. Second, the lack (...) of direct contact from physicians may be harmful to prospective patients. After analysing these issues, this paper argues that there ought to be further consideration for regulation and oversight for these companies. (shrink)

As early as the 1960s and 1970s, astute commentators began to call into question the degree of influence that the pharmaceutical industry was exercising over all aspects of medical research, education, and practice in the U.S. More recently, a spate of books and articles demonstrates that the issue has only become more serious in the last decade or two.My focus in this paper will be on the industry’s influence on medical education. The influence that the industry exerts on undergraduate and (...) graduate medical education often occurs through the system of pharmaceutical sales representatives, who also “detail” drugs to practitioners; or through the influence that the industry exerts over medical research. I will therefore devote my attention here primarily to the system of continuing medical education by which practitioners receive information about medical advances. The pharmaceutical industry currently supports about one-half of the costs of CME in the U.S., so it seems appropriate to question the degree of industry influence over the content of CME. (shrink)

As the debate over how to manage or discourage physicians? financial conflicts of interest with the drug and medical device industries has become more heated, critics have questioned or dismissed the concept of ?conflict of interest? itself. A satisfactory definition relates conflict of interest to concerns about maintaining social trust and distinguishes between breaches of ethical duty and temptations to breach duty. Numerous objections to such a definition have been offered, none of which prevails on further analysis. Those concerned about (...) conflicts of interest have contributed to misunderstandings, however, by failing to demonstrate when social arrangements leading to temptations to breach duties are in themselves morally blameworthy. Clarifying ?conflict of interest? is important if we are eventually going to develop productive modes of engagement between medicine and for-profit industry that avoid the serious ethical pitfalls now in evidence. (shrink)