The growing commercialization of scientific research has raised important concerns about industry bias. According to some evidence, so-called industry bias can affect the integrity of the science as well as the direction of the research agenda. I argue that conceptualizing industry’s influence in scientific research in terms of bias is unhelpful. Insofar as industry sponsorship negatively affects the integrity of the research, it does so through biasing mechanisms that can affect any research independently of the source of funding. Talk about (...) industry bias thus offers no insight into the particular epistemic shortcomings at stake. If the concern is with the negative effects that industry funding can have on the research agenda, conceptualizing this influence as bias obscures the ways in which such impact is problematic and limits our ability to offer solutions that can successfully address the concerns raised by the growing role of private funding in science. (shrink)

The commercialization of academic science has come to be understood as economically desirable for institutions, individual researchers, and the public. Not surprisingly, commercial activity, particularly that which results from patenting, appears to be producing changes in the standards used to evaluate scientists’ performance and contributions. In this context, concerns about a gender gap in patenting activity have arisen and some have argued for the need to encourage women to seek more patents. They believe that because academic advancement is mainly dependent (...) on productivity (Stuart and Ding in American Journal of Sociology 112:97–144, 2006; Azoulay et al. in Journal of Economic Behavior & Organization 63:599–623, 2007), differences in research output have the power to negatively impact women’s careers. Moreover, in the case of patenting activity, they claim that the gender gap also has the potential to negatively affect society. This is so because scientific and technological advancement and innovation play a crucial role in contemporary societies. Thus, women’s more limited involvement in the commercialization of science and technology can also be detrimental to innovation itself. Nevertheless, calls to encourage women to patent on grounds that such activity is likely to play a significant role in the betterment of both women’s careers and society seem to be based on two problematic assumptions: (1) that the methods to determine women’s productivity in patenting activities are an appropriate way to measure their research efforts and the impact of their work, and (2) that patenting, particularly in academia, benefits society. The purpose of this paper is to call into question these two assumptions. (shrink)

Because of the important benefits that biomedical research offers to humans, some have argued that people have a general moral obligation to participate in research. Although the defense of such a putative moral duty has raised controversy, few scholars, on either side of the debate, have attended to the social context in which research takes place and where such an obligation will be discharged. By reflecting on the social context in which a presumed duty to participate in research will obtain, (...) this article shows that decontextualized discussions of this putative moral obligation are problematic. (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)

Disclosure has become the preferred way of addressing the threat to researcher objectivity arising from financial conflicts of interest. This article argues that the effectiveness of disclosure at protecting science from the corrupting effects of FCOIs—particularly the kind of disclosure mandated by US federal granting agencies—is more limited than is generally acknowledged. Current NIH and NSF regulations require disclosed FCOIs to be reviewed, evaluated, and managed by officials at researchers’ home institutions. However, these reviewers are likely to have institutional and (...) personal interests of their own that may undermine the integrity of their evaluations. This paper presents experimental findings suggesting that such interests affect third-party assessments of FCOIs. Over 200 participants gauged the ethical significance of various hypothetical yet realistic FCOIs in academic research settings. Some of them were led to believe they had a small personal interest in allowing conflicted research... (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)

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)

Huddle (2010) claims that the Association of American Medical Colleges (AAMC), in advocating the exclusion of pharmaceutical detail representatives from academic medical centers, erred in placing t...

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)

There is no lack of criticisms frequently levelled against the international pharmaceutical industry (Big Pharma): excessive profits, dubious or even dishonest practices, exploiting the sick and selective use of research data. Neither is there a shortage of examples used to support such opinions. A recent book by Brody (Hooked: Ethics, the Medical Profession and the Pharmaceutical Industry, 2008) provides a précis of the main areas of criticism, adopting a twofold strategy: (1) An assumption that the special nature and human need (...) for pharmaceutical medicines requires that such products should not be treated like other commodities and (2) A multilevel descriptive approach that facilitates an ethical analysis of relationships and practices. At the same time, Brody is fully aware of the nature of the fundamental dilemma: the apparent addiction to (and denial of) the widespread availability of gifts and financial support for conferences etc., but recognises that ‘Remove the industry and its products, and a considerable portion of scientific medicine’s power to help the patient vanishes’ (Brody 2008, p. 5). The paper explores some of the relevant issues, and argues that despite the identified shortcomings and a need for rigorous and perhaps enhanced regulation, and realistic price control, the commercially competitive pharmaceutical industry remains the best option for developing safer and more effective medicinal treatments. At the same time, adoption of a broader ethical basis for the industry’s activities, such as a triple bottom line policy, would register an important move in the right direction and go some way toward answering critics. (shrink)

Experimental design is one aspect of a scientific method. A well-designed, properly conducted experiment aims to control variables in order to isolate and manipulate causal effects and thereby maximize internal validity, support causal inferences, and guarantee reliable results. Traditionally employed in the natural sciences, experimental design has become an important part of research in the social and behavioral sciences. Experimental methods are also endorsed as the most reliable guides to policy effectiveness. Through a discussion of some of the central concepts (...) associated with experimental design, including controlled variation and randomization, this chapter will provide a summary of key ethical issues that tend to arise in experimental contexts. In addition, by exploring assumptions about the nature of causation and by analyzing features of causal relationships, systems, and inferences in social contexts, this chapter will summarize the ways in which experimental design can undermine the integrity of not only social and behavioral research but policies implemented on the basis of such research. (shrink)

When physicians today appeal to “conscience,” it has been alleged such exercises pejoratively reflect “conscience without consequence” as contemporary practitioners are said to be insulated from the consequences of such decisions. It has also been implied these physicians avoid traditional professional responsibilities—including providing charity care and making house or night calls. The assertions demand clarification. Fundamentally, what traits constitute an integrated professionalism specific to Christian physicians? Historical evidence verifies sanctity-of-life affirmations by Christian physicians throughout Church history. However, surveying Christian medical (...) practices in the initial centuries of the Common Era, and more recently in the United States, supports integration of conscience with philanthropy and a rigorous definition of a medical vocation. These suggest there may be deterioration in a holistic commitment to medicine in the United States. Reclaiming an integrated professional paradigm—wherein conscience, philanthropia, and vocation are combined—is essential to an authentic contemporary witness. (shrink)

Many people believe that the research-based pharmaceutical industry has a ‘special’ moral obligation to provide lifesaving medications to the needy, either free-ofcharge or at a reduced rate relative to the cost of manufacture. In this essay, I argue that we can explain the ubiquitous notion of a special moral obligation as an expression of emotionally charged intuitions involving sacred or protected values and an aversive response to betrayal in an asymmetric trust relationship. I then review the most common arguments used (...) to justify the claim that the pharmaceutical industry has a special moral obligation and show why these justifications fail. Taken together, these conclusions call into question the conventional ideologies that have traditionally animated the debate on whether the pharmaceutical industry has special duties of beneficence and distributive justice with respect to the impoverished in dire need of their products. (shrink)

There are some philosophical questions that can be answered without attention to the social context in which evidence is produced and distributed.ing away from social context is an excellent way to ignore messy details and lay bare the underlying structure of the limits of inference. Idealization is entirely appropriate when one is essentially asking: In the best of all possible worlds, what am I entitled to infer? Yet, philosophers’ concerns often go beyond this domain. As an example I examine the (...) debate on mechanistic evidence and then reevaluate a canonical case study in this debate. I show that for the assessment of actual evidence, produced in a world that is far from ideal, omission of the social aspects of medical epistemology leads philosophers to draw the wrong lessons from cases they take as paradigmatic cases for their views. I close by arguing that social epistemology provides an avenue to incorporate these complications and provides the necessary framework to understand medical evidence. (shrink)

The United States, like other countries facing rising health care costs, is pursuing a commitment to interoperable electronic health records. Electronic records, it is thought, have the potential to reduce the risks of error, improve care coordination, monitor care quality, enable patients to participate more fully in care management, and provide the data needed for research and surveillance. Interoperable electronic health records on a national scale — the ideal of a national health information network — seem likely to magnify these (...) advantages. Thus, the recent economic stimulus package contains considerable funding for the development of “health information technology architecture that will support the nationwide electronic exchange and use of health information in a secure, private, and accurate manner.”. (shrink)

There is no doubt that industry-sponsored biomedical research is under the microscope. Unfortunately, this new era of skepticism prematurely rushes in doubts of the ethos of science. Skepticism can lead to positive changes, but only when timely and supported by sound reasoning. Snapshot views and theories, especially those that result in costly new regulations and inefficient policies often do more harm than good. Many critics would have the reader doubt scientific integrity because they believe that the relationship between the pharmaceutical (...) industry and biomedical research poses an unavoidable and dangerous conflict of interest. However, these conflicts are neither unavoidable nor dangerous per se. (shrink)

In their article “Moral Hazards in Pediatrics” (2016), Brunnquell and Michaelson remind us that the child's perspective is of utmost importance when making health care decisions and express concern...

Social, political, and economic environments play an active role in nurturing professional virtue. Yet, these environments can also lead to the erosion of virtue. As such, professional virtue is fragile and vulnerable to environmental shifts. While physicians are often considered to be among the most virtuous of professional groups, concern has also always existed about the impact of commercial arrangements on physicians’ willingness and capacity to enact their professional virtues. This article examines the ways in which commercial arrangements have been (...) negotiated to secure medical virtue from real or perceived threats of erosion. In particular, we focus on the concern surrounding conflicts of interest arising from commercial arrangements that have developed as a result of neoliberal economic and social policies. The deregulation of medical markets and privatization of services have produced new commercial relationships that are often misunderstood by patients, publics, and physicians themselves. ‘Conflicts of interest’ policies have been introduced in an attempt to safeguard ethical conduct and medical practice. However, a number of virtue ethicists have critiqued these policies as inadequate for securing virtue. We examine the ways in which commercial arrangements have been seen to impact upon medical virtue, both historically and in the context of modern medicine. We then describe and critique current efforts to restore clinical virtue through both conflict of interest policies and through virtue ethics. Finally, we suggest some possible ways of addressing the corrosive effects of neoliberalism on medical virtue. (shrink)

Many people believe that the research-based pharmaceutical industry has a ‘special’ moral obligation to provide lifesaving medications to the needy, either free-of-charge or at a reduced rate relative to the cost of manufacture. In this essay, I argue that we can explain the ubiquitous notion of a special moral obligation as an expression of emotionally charged intuitions involving sacred or protected values and an aversive response to betrayal in an asymmetric trust relationship. I then review the most common arguments used (...) to justify the claim that the pharmaceutical industry has a special moral obligation and show why these justifications fail. Taken together, these conclusions call into question the conventional ideologies that have traditionally animated the debate on whether the pharmaceutical industry has special duties of beneficence and distributive justice with respect to the impoverished in dire need of their products. (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)

The Association of American Medical Colleges (AAMC) is urging academic medical centers to ban pharmaceutical detailing. This policy followed from a consideration of behavioral and neuroeconomics research. I argue that this research did not warrant the conclusions drawn from it. Pharmaceutical detailing carries risks of cognitive error for physicians, as do other forms of information exchange. Physicians may overcome such risks; those determined to do so may ethically engage in pharmaceutical detailing. Whether or not they should do so is a (...) prudential judgment about which reasonable people may disagree. The AAMC's ethical condemnation of detailing is unwarranted and will subvert efforts to maintain a realm of physician discretion in clinical work that is increasingly threatened in our present practice environment. (shrink)

The commercialization of academic science has come to be understood as economically desirable for institutions, individual researchers, and the public. Not surprisingly, commercial activity, particularly that which results from patenting, appears to be producing changes in the standards used to evaluate scientists’ performance and contributions. In this context, concerns about a gender gap in patenting activity have arisen and some have argued for the need to encourage women to seek more patents. They believe that because academic advancement is mainly dependent (...) on productivity (Stuart and Ding in American Journal of Sociology 112:97–144, 2006 ; Azoulay et al. in Journal of Economic Behavior & Organization 63:599–623, 2007 ), differences in research output have the power to negatively impact women’s careers. Moreover, in the case of patenting activity, they claim that the gender gap also has the potential to negatively affect society. This is so because scientific and technological advancement and innovation play a crucial role in contemporary societies. Thus, women’s more limited involvement in the commercialization of science and technology can also be detrimental to innovation itself. Nevertheless, calls to encourage women to patent on grounds that such activity is likely to play a significant role in the betterment of both women’s careers and society seem to be based on two problematic assumptions: (1) that the methods to determine women’s productivity in patenting activities are an appropriate way to measure their research efforts and the impact of their work, and (2) that patenting, particularly in academia, benefits society. The purpose of this paper is to call into question these two assumptions. (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)

Twenty-five years after the term "therapeutic misconception’ (TM) first entered the literature, most commentators agree that it remains widespread. However, the majority of scholarly attention has focused on the reasons why a patient cum human subject might confuse the goals of research with the goals of therapy. Although this paper addresses the social and cultural factors that seem to animate the TM among subjects, it also fills a niche in the literature by examining why investigators too might operate under a (...) similar confusion. In framing these issues, the paper expressly adopts a Wittgensteinian approach to evaluating the TM, suggesting that interlocutors do not need any analytic definition of the TM to use the term meaningfully in thinking about the moral implications of the TM in practice. (shrink)

The article reviews the article "The Pitfalls of Deducing Ethics From Behavioral Economics: Why the Association of American Medical Colleges Is Wrong About Pharmaceutical Detailing," by T. S. Huddle in the January 1, 2010 issue of "American Journal of Bioethics.".

BackgroundThe biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope.Main textAny institution with a scientific or healthcare mission should engage bioethics norms to navigate ethical issues that (...) arise from the conduct of biomedical research, delivery of clinical care, or implementation of public health programs. It is reasonable to assume that while bioethics norms must remain constant, their application will vary depending on the characteristics of a given setting. Context “specification” substantively refines ethics norms for a particular discipline or setting and is an expected, needed and progressive ethical activity. In order for this activity to be meaningful, the scope for bioethics application and the relevant contextual factors of the setting need to be delineated and appreciated. This paper defines biopharmaceutical bioethics as: the application of bioethics norms (concepts, principles, and rules) to the research, development, supply, commercialization, and clinical use of biopharmaceutical healthcare products. It provides commentary on this definition, and presents five contextual factors that need to be considered when applying bioethics norms to a biopharmaceutical industry setting: (1) dual missions; (2) timely and pragmatic guidance; (3) resource stewardship; (4) multiple stakeholders; and (5) operational complexity.ConclusionUnderstanding the scope of the biopharmaceutical enterprise and contextual factors of a biopharmaceutical industry setting is foundational for the application of bioethics norms. Establishing a common language and approach for biopharmaceutical bioethics will facilitate breadth and depth of discussion and subsequent implementation to benefit patients, the healthcare system and society. (shrink)

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)

While pharmaceutical industry involvement in producing, interpreting, and regulating medical knowledge and practice is widely accepted and believed to promote medical innovation, industry-favouring biases may result in prioritizing corporate profit above public health. Using diabetes as our example, we review successive changes over forty years in screening, diagnosis, and treatment guidelines for type 2 diabetes and prediabetes, which have dramatically expanded the population prescribed diabetes drugs, generating a billion-dollar market. We argue that these guideline recommendations have emerged under pervasive industry (...) influence and persisted, despite weak evidence for their health benefits and indications of serious adverse effects associated with many of the drugs they recommend. We consider pharmaceutical industry conflicts of interest in some of the research and publications supporting these revisions, and in related standard-setting committees and oversight panels. We raise concern over the long-term impact of these multifaceted involvements. Rather than accept industry conflicts of interest as normal, needing only to be monitored and managed, we suggest challenging that normalcy, and ask: what are the real costs of tolerating such industry participation? We urge the development of a broader focus to fully understand and curtail the systemic nature of industry’s influence over medical knowledge and practice. (shrink)

There is an old saw in health policy that everyone wants health care that is good, fast, and cheap — but it’s impossible to have more than two of these at one time.A similar bit of folk wisdom seems intuitively true for the development and testing of new pharmaceutical products. The public is in a bind. We want breakthrough drugs, and fast. But we also want these drugs to be affordable, thoroughly tested, safe, and effective. It seems we can’t have (...) it all.In this paper, we will not claim that one can have it all — but that we can do far better than we are at present. First, we review extensive data on contemporary problems in the design, conduct, and analysis of industry-sponsored clinical trials. Finding major issues that have been solidly documented over more than a decade, we provide many examples of the multifarious ways in which industry-funded trials have been manipulated to raise the likelihood of producing industry-friendly results. (shrink)