It is easier to resist at the beginning than at the end.– Leonardo da VinciPhysicians often believe that a conscious commitment to ethical behavior and professionalism will protect them from industry influence. Despite increasing concern over the extent of physician-industry relationships, physicians usually fail to recognize the nature and impact of subconscious and unintentional biases on therapeutic decision-making. Pharmaceutical and medical device companies, however, routinely demonstrate their knowledge of social psychology processes on behavior and apply these principles to their marketing. (...) To illustrate how pharmaceutical marketing strategies use psychological techniques to promote targeted therapies, we draw on the relevant social psychology literature on conflicts of interest and on the six principles of influence articulated by the eminent social psychologist Robert Cialdini. Hospitals, professional organizations, medical educators, and other stakeholders must also draw on social psychology to respond effectively to commercial activities that compromise good medical practice. (shrink)

Non-financial interests, and the conflicts of interest that may result from them, are frequently overlooked in biomedicine. This is partly due to the complex and varied nature of these interests, and the limited evidence available regarding their prevalence and impact on biomedical research and clinical practice. We suggest that there are no meaningful conceptual distinctions, and few practical differences, between financial and non-financial conflicts of interest, and accordingly, that both require careful consideration. Further, a better understanding of the complexities of (...) non-financial conflicts of interest, and their entanglement with financial conflicts of interest, may assist in the development of a more sophisticated approach to all forms of conflicts of interest. (shrink)

Good decision-making requires reliable information. In medicine, relevant information comes from clinical trials and other forms of scientific research. In business, one source is in corporate annual financial statements. As for-profit, publicly traded companies whose business is discovering, manufacturing, and marketing drugs, pharmaceutical companies sit at the nexus of these two fields. Determining the safety and efficacy of a pharmaceutical product and determining the profitability of a complex enterprise are similarly difficult tasks: each is fraught with deeply ambiguous information that (...) requires sophisticated judgment to interpret reasonably. (shrink)

The Food and Drug Administration authorizes the marketing of a drug only for uses that the manufacturer has demonstrated to be safe and effective, based on evidence from at least two clinical trials. However, the FDA does not regulate the practice of medicine, so physicians may prescribe drugs in any manner they choose. Prescribing drugs in ways that deviate from the uses specified in the FDA-approved drug label, package insert, and marketing authorization is referred to as off-label prescribing. This occurs (...) when physicians prescribe a drug for a therapeutic purpose other than the one approved by the FDA; treat patients in a different age cohort or gender than the population on which it was tested; or prescribe a different dose, for a different duration of use, or a different mode of administration than indicated on the label. (shrink)

This article focuses on patients' participation in decision‐making in meetings with healthcare professionals in a healthcare system, based on neoliberal regulations and ideas. Drawing on two constructed empirical cases, primarily from the perspective of patients, this article analyses and discusses the clinical practice around decision‐making meetings within a Foucauldian perspective. Patients' participation in decision‐making can be seen as an offshoot of respect for patient autonomy. A treatment must be chosen, when patients consult physicians. From the perspective of patients, there is (...) a tendency for healthcare professionals to supply the patients with the information that they think are necessary for them to make their own decision. But patients do not always want to be a ‘customer’ in the healthcare system; they want to be a patient, consulting an expert for help and advice, which creates resistance to some parts of the decision‐making process. Both professionals and patients are subject to the structural frame of the medical field, formed of both neoliberal framework and medical logic. The decision‐making competence in relation to the choice of treatment is placed away from the professionals and seen as belonging to the patient. A ‘projectification’ of the patient occurs, whereby the patient becomes responsible for his/her choices in treatment and care and the professionals support him/her with knowledge, preferences, and alternative views, out of which he/she must make his/her own choices, and the responsibility for those choices now and in the future. At the same time, there is a tendency towards de‐professionalization. In that light, participation of patients in decision‐making can be regarded as a tacit governmentality strategy that shapes the location of responsibility between individual and society, and independent patients and healthcare professionals, despite the basically desirable, appropriate, and necessary idea of involving patients in their own situations from a humanistic perspective. (shrink)

The profession of medicine is predicated upon an ethical mandate: first do no harm. However, critics charge that the medical profession’s culture and its public health mission are being undermined by the pharmaceutical industry’s wide-ranging influence. In this article, we analyze how drug firms influence psychiatric taxonomy and treatment guidelines such that these resources may serve commercial rather than public health interests. Moving beyond a conflict-ofinterest model, we use the conceptual and normative framework of institutional corruption to examine how organized (...) psychiatry’s dependence on drug firms has distorted science. We suggest that academic-industry relationships have led to the corruption of the evidence base upon which accurate diagnosis and sound treatment depend. We describe the current dependency corruption and argue that transparency alone is not a solution — and sometimes even produces iatrogenic effects. Furthermore, we argue that the corruption of the evidence base for diagnostic and practice guidelines renders obsolete the traditional informed consent process, and we offer suggestions for reforming this process. (shrink)

Medical necessity (claiming that a medical intervention or care is – at minimum – reasonable, appropriate and acceptable) depends on empirical evidence and on the interpretation of that evidence. Evidence and its interpretation define the standard of care. This commentary argues that both the evidence base and its interpretation are currently weak gatekeepers. Empirical meta-research suggests that very few medical interventions have high quality evidence in support of their effectiveness and very few of them also have relatively thorough assessments of (...) their potential harms. Therefore, evidence on the risk-benefit ratios carries almost always very large uncertainty. Arbitration about medical necessity is thus left to the interpretation process. Professional guidelines are notoriously unreliable and biased in this regard. Regulatory approval ends up being the key arbitrator, but over the years the regulatory process has been subverted. Regulatory approval currently does not mean that an intervention has a favourable risk-benefit ratio, but simply that it can be marketed, sold and made profit from. The process leads to a tragedy of commons where the final victim is society at large: medical necessity is invoked as an alibi for medicine to absorb societal resources. (shrink)

Financial relationships and business transactions between physicians and the health care industry are common. These relationships take a variety of forms, including payments to physicians in exchange for consulting services, reimbursement of physician travel expenses when attending medical device and pharmaceutical educational conferences, physician ownership in life science company stocks, and the provision of free drug samples. Such practices are not intrinsic to medical practice, but as the Institute of Medicine described in its 2009 report, these relationships have the potential (...) to produce positive collaborations that improve patient care and public health, and most physicians view it as “ethically proper to accept items ranging from drug samples to a lucrative consultantship.”However, financial relationships between physicians and pharmaceutical, medical device and biotechnology companies can also create negative influences on physician judgment that compromise patient care and jeopardize the public’s trust. (shrink)

Conflicts of interest in health and medicine have been the source of considerable public and professional debate. Much of this debate has focused on financial, rather than non-financial COI, which is a significant lacuna because non-financial COI can be just as influential as financial COI. In an effort to explore the nature and effects of non-financial, as well as financial COI, we conducted semi-structured interviews with eleven Australian medical professionals regarding their experiences of, and attitudes towards, COI. We found that (...) this group of medical professionals saw non-financial interests—most notably the pursuit of status and respect and the avoidance of stigma—as potentially conflicting with other important interests. (shrink)

BackgroundThe International Committee of Medical Journal Editors Recommendations set ethical and editorial standards for article publication in most leading medical journals. Here, I examine the strengths and weaknesses of the Recommendations in the prevention of commercial bias in industry-financed journal literature, on three levels – scholarly discourse, article content, and article attribution.DiscussionWith respect to overall discourse, the most important measures in the ICMJE Recommendations are for enforcing clinical trial registration and controlling duplicate publication. With respect to article content, the ICMJE (...) promotes stringent author accountability and adherence to established reporting standards. However, the ICMJE accepts the use of commercial editorial teams to produce manuscripts, which is a potential source of bias, and accepts private company ownership and analysis of clinical trial data. New ICMJE guidance on data sharing will address but not eliminate problems of commercial data access. With respect to attribution, the Recommendations oppose guest authorship and encourage clear documentation of author contributions. However, they exclude writers from coauthorship; provide no specific advice on the attribution of commercial literature, for instance with respect to company authorship, author sequence or prominent commercial labeling; and endorse the use of fine print and euphemism. The ICMJE requires detailed author interest disclosures, but overlooks the interests of non-authors and companies, and does not recommend that interests most salient to the publication are highlighted. Together, these weaknesses facilitate “advocacy”-based marketing, in which literature planned, financed and produced by companies is fronted by academics, enabling commercial messages to be presented to customers by their respected clinical peers rather than companies themselves.ConclusionsThe ICMJE Recommendations set important research and reporting standards, without which commercial bias would likely be a significantly greater problem than it is today. However, they also support practices of commercial data control, content development and attribution that run counter to science’s values of openness, objectivity and truthfulness. These weaknesses could be addressed with appropriate modifications to the Recommendations. The ICMJE should also disclose its own commercial interests and funding – not least because publishing organizations that finance it and pay the salaries of some member editors derive substantial revenues from industry. (shrink)

Could an accreditation, certification, or rating mechanism help the pharmaceutical industry improve both its bioethical performance and its public reputation? Other industries have used such systems to assess, improve, distinguish, and demonstrate the quality of their services, processes, and products. These systems have also helped increase transparency, accountability, stakeholder confidence, and awareness of industry best practices. This article explains how market forces can be harnessed to recognize and promote better bioethical performance by pharmaceutical companies when there are good systems to (...) accredit, certify, or rate. It concludes with a review of relevant failures of credit-rating agencies — such as conflicts of interests and revolving-door practices — to illuminate some of the pitfalls of developing a bioethics accreditation, certification, or rating system for pharmaceutical companies. (shrink)

In September 2006, a small start-up company in Cambridge, MA called Sermo, Inc., launched a social networking site with an unusual twist: only physicians practicing medicine in the United States would be allowed to participate. Sermo, which means “conversation” in Latin, marketed its website as an online community exclusively for doctors that would allow them to talk openly about a range of topics, from challenging and unusual medical cases to the relative merits of one treatment versus another. “Sermo enables the (...) private and instant exchange of knowledge among MDs,” the company announced in its first press release. Even better, participation was free and the site carried no advertising. (shrink)

Scientism in medical education distracts educators from focusing on the content of learning; it focuses attention instead on individual achievement and validity in its measurement. I analyze the specific form that scientism takes in medicine and in medical education. The competencies movement attempts to challenge old “scientistic” views of the role of physicians, but in the end it has invited medical educators to focus on validity in the measurement of individual performance for attitudes and skills that medicine resists conceptualizing as (...) objective. Academic medicine should focus its efforts instead on quality and relevance of care. The social accountability movement proposes to shift the focus of academic medicine to the goal of high quality and relevant care in the context of community service and partnership with the institutions that together with medicine create and cope with health and with health deficits. I make the case for this agenda through a discussion of the linked histories of the opioid prescribing crisis and the professionalism movement. (shrink)

Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying (...) skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations. (shrink)