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)

The pharmaceutical industry, in its marketing efforts, often turns to “key opinion leaders” or “KOLs” to disseminate scientific information. Drawing on the author's fieldwork, this article documents and examines the use of KOLs in pharmaceutical companies’ marketing efforts. Partly due to the use of KOLs, a small number of companies with well-defined and narrow interests have inordinate influence over how medical knowledge is produced, circulated, and consumed. The issue here, as in many other cases of institutional corruption, is that a (...) few actors have accumulated the power to shape the information on which many others base their decisions. Efforts to address this corruption should focus on correcting large imbalances in the current political economy of medical knowledge. A sequestration of pharmaceutical research and development on one hand from pharmaceutical marketing on the other, though difficult to achieve, would address this and many other problems. (shrink)

A recent study by Olivieri et al, published in PLOS ONE, reports that between 2009 and 2015 a third of patients with thalassaemia in Canada’s largest hospital were switched from first-line licensed drugs to regimens of deferiprone, an unlicensed drug of unproven safety and efficacy. Based on retrospective data from patient records, the PLOS Study reports that patients treated with deferiprone, either as monotherapy or in combination with first-line drugs, suffered serious adverse effects. The data reported by Olivieri et al (...) give rise to a number of ethical issues. These ethical issues are identified, placed in historical context and analysed. For purposes of this analysis, reliance is placed on two core principles of research ethics, harm minimisation and informed consent, and also on the hospital’s mission statement. Then a mystery is explored: How and why did it happen that Toronto’s University Health Network treated large numbers of patients with an unlicensed drug over a period of many years? ‘Institutional conflict of interest’ is considered as a possible explanatory hypothesis. (shrink)

Relationships between physicians and pharmaceutical sales representatives (PSRs) often create conflicts of interest, not least because of the various benefits received by physicians. Many countries attempt to control pharmaceutical industry marketing strategies through legal regulation, and this is true in Poland where efforts are underway to eliminate any practices that might be considered corrupt in medicine. The present research considered Polish medical students’ opinions about domestic laws restricting doctors’ acceptance of expensive gifts from the industry, the idea of compulsory transparency, (...) and the possibility of introducing a Polish Sunshine Law. A qualitative, focus group-based, interview method was used. Data were gathered from nine focus groups involving 92 medical students from three universities located in major Polish cities. The article presents a classification of opposing student views with regard to the consequences of introducing different legal solutions; this should be useful for policy makers deliberating on how to optimally regulate pharmaceutical marketing. The study’s results are discussed in the context of the public bioethical debate in Poland. (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)

Improper dependencies slant policy over a drug's life span, biasing the development of new drugs, the testing and marketing approval for new drugs, and the monitoring of patient safety after drugs are marketed. This article examines five ways in which the public improperly depends on pharmaceutical firms that compromise the integrity of pharmaceutical policy. Today the public relies on pharmaceutical firms: (1) to set priorities on drug research and development; (2) to conduct clinical trials to test whether drugs are safe (...) and effective; (3) to decide what clinical trial data to disclose to the public; (4) to monitor post marketing drug safety; (5) to supply product information to physicians and to finance continuing medical education and other professional activities. The article suggests options to overcome each of these dependencies. (shrink)

The federal government indirectly subsidizes the pharmaceutical industry by funding basic research, various tax credits and deductions, patent rules, grants of market exclusivity, and other means, in order to spur drug development, promote public health, and improve medical care. But today, the pharmaceutical industry often neglects these goals and sometimes even undermines them, due to what Lawrence Lessig refers to as institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution’s objectives or integrity. A key (...) source of institutional corruption is improper dependence by the institution or its key actors on the actions of third parties that have fundamentally different interests. It is the health care system’s improper dependency on pharmaceutical firms that allows them to displace some public policy goals and to compromise the attainment of others. (shrink)

The rise of liberal market economies, propagated by neoliberal free market thought, has created a vacant responsibility for public interests in the market order of society. This development has been critiqued by Catholic social teaching (CST), forcefully arguing that governments and businesses should be directed to the common good. In this debate, no attention has yet been given to the Reformational tradition and its principle of sphere sovereignty, which provides guidelines on the responsibilities of governments and companies for the public (...) interest of society. This article analyzes the differences and similarities between CST and the Reformational philosophy in their critiques of the neoliberal free market perspective of Hayek. We apply the three perspectives to the case of orphan drugs in the pharmaceutical industry and show that CST and the Reformational philosophy offer valuable insights in correction to Hayek’s views on the responsibilities of governments and companies for public health interests. (shrink)

With dwindling support from governments toward universities, university–industry partnerships have increased. Ethical concerns over such partnerships have been documented, are particularly relevant when an institution receives money from a corporation whose products do harm and are intensified for academic public health institutions whose missions include promoting well-being. Academics in medicine and nutrition have often failed to recognize the potential conflicts of industry-sponsored research. It is unclear if research to date has explored attitudes of public health academics toward accepting such funds. (...) The objective of this research was to review systematically the attitudes of public health academics with respect to accepting funds from for-profit corporations. Four electronic databases were searched as well as the archives of the Chronicles of Higher Education. The search strategy was based on four main domains: for-profit organizations, funding, public health and academia. This search resulted in a total of 4017 articles reviewed. No articles were found that investigated the attitudes of public health academics toward accepting funds from industry. The lack of articles addressing public health academicians’ perspective toward accepting industry funds is striking. Research regarding this topic can guide development of policies that minimize the negative consequences of industry funding. (shrink)

There is overwhelming evidence that the opioid crisis—which has cost hundreds of thousands of lives and trillions of dollars (and counting)—has been created or exacerbated by webs of influence woven by several pharmaceutical companies. These webs involve health professionals, patient advocacy groups, medical professional societies, research universities, teaching hospitals, public health agencies, policymakers, and legislators. Opioid companies built these webs as part of corporate strategies of influence that were designed to expand the opioid market from cancer patients to larger groups (...) of patients with acute or chronic pain, to increase dosage as well as opioid use, to downplay the risks of addiction and abuse, and to characterize physicians’ concerns about the addiction and abuse risks as “opiophobia.” In the face of these pervasive strategies, conflict of interest policies have proven insufficient for addressing corporate influence in medical practice, medical research, and public health policy. Governments, the academy, and civil society need to develop counterstrategies to insulate themselves from corporate influence and to preserve their integrity and public trust. These strategies require a paradigm shift—from partnerships with the private sector, which are ordinarily vehicles for corporate influence, to a norm of separation. (shrink)

A growing number of doctors in the United States are joining online professional networks that cater exclusively to licensed physicians. The most popular are Sermo, with more than 135,000 members, and Doximity, with more than 100,000. Both companies claim to offer a valuable service by enabling doctors to “connect” in a secure online environment. But their business models raise ethical concerns. The sites generate revenue by selling access to their large networks of physician-users to clients that include global pharmaceutical companies, (...) market research and consulting firms, and hedge funds and other investors. In exchange for a fee, these clients are offered a variety of tools to monitor, analyze, and solicit physicians’ opinions. In Sermo's case, clients are also offered opportunities to conduct “awareness campaigns” on the site that are aimed at influencing physician sentiment about specific drugs and medical devices. In effect, these online networks have created an even more efficient means for the pharmaceutical industry to track physician sentiment, disseminate messages, and cultivate key opinion leaders. This paper argues that the dual nature of these sites (a) undermines their integrity and transparency as forums for the exchange of medical opinion and (b) presents an ethical conflict for the doctors who use them. (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)

Stephen John has recently suggested that the ethics of communication yields important insights as to how values should be incorporated into science. In particular, he examines cases of “wishful speaking” in which a scientific actor endorses unreliable conclusions in order to obtain the consequences of the listener treating the results as credible. He concludes that what is wrong in these cases is that the speaker surreptitiously relies on values not accepted by the hearer, violating what he terms “the value-apt ideal”. (...) I expand on this view by integrating into it Miranda Fricker’s account of testimonial injustice. I find testimonial injustice can arise in a manner unanticipated by Fricker, specifically that a credibility excess given to a speaker typically reduces the ability of others in the epistemic community to transmit knowledge, a phenomenon I term “collateral epistemic injustice”. I argue that this possibility entails that receivers have an ethical obligation to assign credibility judiciously. A further consequence of this view is that the value-apt ideal is insufficient. Because audience members have an obligation to assign credibility judiciously, a speaker cannot merely rely on shared values, they must also be open about the extent to which their conclusions depend on those values. Thus, both wishful speaking and obscuring the value-dependent nature of a conclusion makes one an unreliable source of information. Accordingly, other community members have an ethical obligation to ignore a speaker that frequently engages in either. (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)

CRISPR-Cas9 genome editing can and has altered human genomes, bringing bioethical debates about this capability to the forefront of philosophical and policy considerations. Here, I consider the underexplored implications of CRISPR-Cas9 gene drives for heritable human genome editing. Modification gene drives applied to heritable human genome editing would introduce a novel form of involuntary eugenic practice that I term guerrilla eugenics. Once introduced into a genome, stealth genetic editing by a gene drive genetic element would occur each subsequent generation irrespective (...) of whether reproductive partners consent to it and irrespective of whether the genetic change confers any benefit. By overriding the ability to ‘opt in’ to genome editing, gene drives compromise the autonomy of carrier individuals and their reproductive partners to choose to use or avoid genome editing and impose additional burdens on those who hope to ‘opt out’ of further genome editing. High incidence of an initially rare gene drive in small human communities could occur within 200 years, with evolutionary fixation globally in a timeframe that is thousands of times sooner than achievable by non-drive germline editing. Following any introduction of heritable gene drives into human genomes, practices intended for surveillance or reversal also create fundamental ethical problems. Current policy guidelines do not comment explicitly on gene drives in humans. These considerations motivate an explicit moratorium as being warranted on gene drive development in heritable human genome editing. (shrink)

Pharmaceutical sales representatives (PSRs) are one of the most frequently used drug information sources for physicians in both the United States and China. During face-to-face interactions, PSRs use various promotional strategies to impact the prescribing behavior. In the United States, PSRs provide physicians small gifts, free drug samples, and “sincere friendships”, whereas in China, they played an indispensable role in medical corruption over the past three decades. To cope with the undue influence of PSRs, both these countries have taken positive (...) but insufficient measures to eliminate the effect thus far. By comparing the strategies of American and Chinese PSRs, it was found that building a friendly personal relationship with physicians in a relatively closed private environment (such as physician’s office) is a key factor to exert an individualized influence on physicians, even in different social backgrounds and healthcare contexts. Therefore, this essay suggests that it is necessary to limit the establishment of personal relationships and maintain a more professional interaction to reduce the personalized psychological and emotional influences on physicians’ professional judgment. To achieve this goal, it is proposed to transfer the physician-PSR interaction to a professional public space as a supplement to current countermeasures and suggestions. The presence of others and the possibility of third party participation will stimulate more ethical and reputational concerns. It is hoped that the increased transparency of the interaction will promote participants to consider more professional norms and mitigate the undue influence of PSRs’ individualized strategies. (shrink)

Volume 20, Issue 4, May 2020, Page 59-61.

Pharmaceutical industry marketers are confronted with specific ethical issues linked to the tension between the economic interest being pursued and the health mission of this sector. Indeed this dual mission could be problematic for them when the two objectives contradict each other. We use the concept of moral dissonance to examine how marketers in the pharmaceutical industry perceive the profit/health tension inherent in their sector and how they deal with it. Based on narratives of 18 marketers working in the pharmaceutical (...) sector, our qualitative study identifies ethical conflicts of varying intensity that generate differing degrees of moral dissonance among marketers. To cope with this moral dissonance, they use the following strategies: (1) minimize the sensitivity of their activity; (2) invoke the benefits to patients; and (3) avoid behaviors that conflict with their values. (shrink)

Many factors contribute to the inappropriate use of medicines, including not only a lack of information but also inaccurate and misleading promotional information. This review examines how the promotion of pharmaceuticals directly affects the prescribing and use of medicines. We define promotion broadly as all actions taken directly by pharmaceutical companies with the aim of enhancing product sales. We look in greater detail at promotion techniques aimed at prescribers, such as sales representatives, pharmaceutical advertisements in medical journals and use of (...) key opinion leaders, along with the quality of information provided and the effects thereof. We also discuss promotion to the public, through direct-to-consumer advertising, and its effects. Finally, we consider initiatives to regulate promotion that come from industry, government and nongovernmental organizations. (shrink)