Conflicts of interest are receiving increased attention in medical research, clinical practice and education. Criticism of, and penalties for, conflicts of interest have been insufficiently discussed and have been applied without adequate conceptual backing. Genuine conflicts of interest are situations in which alternative courses of action are ethically equivalent, decision-making being less a matter of moral deliberation than of personal weighing of interest. In contrast, situations usually thought of as conflicts of interest are mostly temptations to follow an attractive but (...) undue option that causes harm by failing to uphold well-entrenched ethical standards. Examples of moral quandaries that pose as ethically neutral conflicts of interest are healthcare providers enticed to favour certain products; patients being referred to non-therapeutic trials entailing risks and non-optimal healthcare; industry-supported scientists failing to deliver unbiased research results and reports or participating in ghost-writing; and sponsored educators who praise their supporters beyond objective evidence. All these are moral blemishes, where integrity gives way to material incentives at the cost of provoking risky and harm-producing situations, thus constituting false conflicts of interest when they are in fact ethical misdemeanours. Disclosure has been the most widely recommended response to avoid the concealment of conflicting and ethically suspect interests. Regulations regarding disclosure reveal a utilitarian stance that shows more concern for the magnitude of support or sponsorship than for the underlying ethical transgression. Education and oversight should directly address and help correct the moral attitude towards undue influence of inducements and marketing strategies falsely posing as conflicts of interest. (shrink)

The controversy over the old ideal of “value-free science” has cooled significantly over the past decade. Many philosophers of science now agree that even ethical and political values may play a substantial role in all aspects of scientific inquiry. Consequently, in the last few years, work in science and values has become more specific: Which values may influence science, and in which ways? Or, how do we distinguish illegitimate from illegitimate kinds of influence? In this paper, I argue that this (...) problem requires philosophers of science to take a new direction. I present two case studies in the influence of values on scientific inquiry: feminist values in archaeology and commercial values in pharmaceutical research. I offer a preliminary assessment of these cases, that the influence of values was legitimate in the feminist case, but not in the pharmaceutical case. I then turn to three major approaches to distinguish legitimate from illegitimate influences of values, including the distinction between epistemic and non-epistemic values and Heather Douglas’ distinction between direct and indirect roles for values. I argue that none of these three approaches gives an adequate analysis of the two cases. In the concluding section, I briefly sketch my own approach, which draws more heavily on ethics than the others, and is more promising as a solution to the current problem. This is the new direction in which I think science and values should move. (shrink)

While most of healthcare research and practice fully endorses evidence-based healthcare, a minority view borrows popular themes from philosophy of science like underdetermination and value-ladenness to question the legitimacy of the evidence-based movement’s philosophical underpinnings. While the feminist origins go unacknowledged, those critics adopt a feminist reading of the “gap argument” to challenge the perceived objectivism of evidence-based practice. From there, the critics seem to despair over the “subjective elements” that values introduce to clinical reasoning, demonstrating that they do not (...) subscribe to feminist science studies’ normative program——where contextual values can enable good science and justified decisions. In this paper, I investigate why it is that the critics of evidence-based medicine adopt feminist science’s characterization of the problem but resist the productive solutions offered by those same theorists. I suggest that the common feminist empiricist appeal to idealized epistemic communities is impractical for those working within the current biomedical context and instead offer an alternate stream of feminist research into the empirical content of values (found in the work of Elizabeth Anderson and Sharyn Clough) as a more helpful recourse for facilitating the important task of legitimate and justified clinical decision-making. I use a case study on clinical decision-making to illustrate the fruitfulness of the latter feminist empiricist framework. -/- See response by Sharyn Clough: http://wp.me/p1Bfg0-1aN See reply by Maya Goldenberg: http://wp.me/p1Bfg0-1oY. (shrink)

In this article I explore the underlying political philosophy of public bioethics by comparing it to technocratic authority, particularly the technocratic authority claimed by economists in Mexico in the 1980s and 1990s. I find that public bioethics - at least in the dominant forms - is implicitly designed for and tries to use technocratic authority. I examine how this type of bioethics emerged and has continued. I finish by arguing that, as claims to technocratic authority go, bioethics is in an (...) incredibly weak position, which partly explains why it has never gained the degree of public legitimacy that other technocracies have gained. I conclude by arguing for a "technocracy-lite" orientation for public bioethics. (shrink)

. The potential for financial conflicts of interest to influence scientific research has become a significant concern. Some commentators have suggested that the development of standardized study protocols could help to alleviate these problems. This paper identifies two problems with this solution: scientific research incorporates numerous methodological judgments that cannot be constrained by standardized protocols; and standardization can hide significant value judgments. These problems arise because of four weaknesses of standardized guidelines: incompleteness, limited applicability, selective ignorance, and ossification. Therefore, the (...) standardization of study designs should not serve as an alternative to addressing the interests and power relations that pervade science policy-making. Policy makers should take at least two steps to prevent powerful interest groups from co-opting standardized guidelines. First, their development and review should be made as transparent as possible and should be subjected to broadly-based deliberation. Second, standardized guidelines should be supplemented with efforts to scrutinize the conditions under which financial COIs tend to have the most worrisome effects so that additional steps can be taken to eliminate and mitigate those conditions. (shrink)

Presently, the pharmaceutical industry funds about half of the costs of continuing medical education programs in the U.S. This contributes to the ethical problems that pervade the relationship between medicine and the pharmaceutical industry: trustworthiness and conflicts of interest. The problems are exacerbated by rationalizations prevalent on both sides that deny the ethical concerns. Commercialism and commercial bias are highly visible at large CME gatherings, and available data, while scanty, back up the view that physician attendees' subsequent prescribing practices are (...) influenced by the commercial message. The industry believes that it will recoup $3.56 in increased sales for every dollar that it invests in CME. New guidelines instituted by the Accreditation Council for Continuing Medical Education in 2004 may succeed in reducing excessive commercial influence, especially since the Department of Health and Human Services has also warned the industry of possible anti-kickback violations if firewalls are not erected between CME funding and marketing of drugs. Critics counter that early indicators of improvement are lacking. (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)

Publication of pharmaceutical company-sponsored research in medical journals, and its presentation at conferences and meetings, is mostly governed by ‘publication plans’ that extract the maximum amount of scientific and commercial value out of data and analyses through carefully constructed and placed papers. Clinical research is typically performed by contract research organizations, analyzed by company statisticians, written up by independent medical writers, approved and edited by academic researchers who then serve as authors, and the whole process organized and shepherded through to (...) journal publication by publication planners. This paper reports on a conference of an international association of publication planners. It describes and analyzes their work in an ecological framework that relates it to marketing departments of pharmaceutical companies, medical journals and publishers, academic authors, and potential audiences. The medical research described here forms a new kind of corporate science, designed to look like traditional academic work, but performed largely to market products. (shrink)