Trust in the nurse—patient relationship is maintained not by how professionals perceive their actions but rather by how the public perceives them. However, little is known about the public's view of nurses and other health care professionals who participate in pharmaceutical marketing. Our study describes public perceptions of health care providers' role in pharmaceutical marketing and compares their responses with those of a random sample of licensed family nurse practitioners. The family nurse practitioners perceived their participation in marketing activities as (...) significantly more ethically appropriate than did the public responders. Further research is warranted before conclusions can be drawn, but these early findings suggest that nurse practitioners should consider a conservative approach to participating in pharmaceutical marketing. (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)

Brody (2011) claims that clarifying conflict of interest (COI) is important for several reasons. Brody's paper seems to focus on the importance of raising awareness of the impact of COI and the nee...

Increasing pharmaceutical industry presence in health care research and practice has evoked critical social, political, economic, and ethical questions and concern among health care providers, ethicists, economists, and the general citizenry. The case example presented of the ‘marketization’ of nursing practice not only reveals the magnitude of the purview of the pharmaceutical industry, it demonstrates how that industry imparts effect upon the organization of nursing work, an area of health care professional practice where the ethical polemic of pharmaceutical industry involvement (...) and influence has been largely ignored, and the profession of nursing conspicuously silent. Drawing on a Foucauldian dispositive analysis that troubled the complex apparatus responsible for the production of knowledge and action in the neurology subspecialty of multiple sclerosis (MS), the case discloses how the pharmaceutical industry has created compliance and adherence as clinical imperatives in the practice of MS nursing. The case makes explicit the conscious transformative self‐action undertaken by MS nurses as a result of their subjectivation (marketization) and demonstrates how MS nurses have become pawns in pharmaceutical industry strategic games of power, truth, identity, and wealth creation by turning their clinical practice settings into heterodiscursive spaces of surveillance and persuasion. MS nurses have become instruments of the pharmaceutical industry, and their clinical practices ordered, organized, limited, constrained, and marketized as a result. (shrink)

Recent professional guidelines published by the General Medical Council instruct physicians in the UK to be honest and open in any financial agreements they have with their patients and third parties. These guidelines are in addition to a European policy addressing disclosure of physician financial interests in the industry. Similarly, In the US, a national open payments program as well as Federal regulations under the Affordable Care Act re-address the issue of disclosure of physician financial interests in America. These new (...) professional and legal changes make us rethink the fiduciary duties of providers working under new organizational and financial schemes, specifically their clinical fidelity and their moral and professional obligations to act in the best interests of patients. The article describes the legal changes providing the background for such proposals and offers a prima facie ethical analysis of these evolving issues. It is argued that although disclosure of conflicting interest may increase trust it may not necessarily be beneficial to patients nor accord with their expectations and needs. Due to the extra burden associated with disclosure as well as its implications on the medical profession and the therapeutic relationship, it should be held that transparency of physician financial interest should not result in mandatory disclosure of such interest by physicians. It could lead, as some initiatives in Europe and the US already demonstrate, to voluntary or mandatory disclosure schemes carried out by the industry itself. Such schemes should be in addition to medical education and the address of the more general phenomenon of physician conflict of interest in ethical codes and ethical training of the parties involved. (shrink)

Clinical ethics takes on a special cast in a rehabilitation clinic for psychosis where many patients come from severely disadvantaged backgrounds and many suffer from fluctuating decisional capacity. This paper illustrates several ethical issues—truth telling and partiality, prescribing concealed medication, questionable billing practices, industry collaboration, limits of confidentiality, grounds for abandonment and the primacy of autonomy—in the hope that discussing such matters will lead to a clearer framework for work with this population.

Concern about financial conflicts crowds out sufficient consideration of other interests that may bias research conduct. Regulations, institutional policies, and guidance from professional bodies and medical journals all primarily focus on financial ties. But why? Economic gain is not the only powerful influence. This article argues that we under-prioritize non-financial interests in the regulation of medical research. It critiques the usual reasons given for regulating financial and non-financial interests differently — that the interests contrast in terms of tangibility, that financial (...) interests are optional, and that financial interests can be efficiently carved out as a discrete area of focus. Moreover, disparate regulatory treatment seems inattentive to the very similar social and psychological forces that animate the bias effect of both financial and non-financial interests and fails to account for how financial and non-financial interests synergistically interact. Under-prioritization of non-financial interests threatens to erode public trust and creates negative spillover effects that weaken financial conflicts regulation. Optimal regulation requires a more integrated, balanced, and proportionate response to secondary interests in medical research. (shrink)

Conflicts of interest have been reduced to financial conflicts. The National Institutes of Health’s new rules for managing conflicts of interest in medical research, the first major change to the regulations in over 15 years, address only financial ties. Although several commentators urged that the regulations also cover non-financial interests, the Department of Health and Human Services declined to do so. Similarly, the Institute of Medicine’s influential 2009 Conflict of Interest Report focuses almost exclusively on financial conflicts. Institutional policies at (...) academic medical centers and guidance from professional bodies and medical journals also primarily emphasize financial ties. Even broadly worded rules are applied more readily to financial ties than non-financial interests, such as the regulations that restrict institutional review board members with conflicting interests from participating in protocol reviews. (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)

In the last decade, there has been increased recognition of the importance of disclosing and managing non-financial conflicts of interests to safeguard the objectivity, integrity, and trustworthiness of scientific research. While funding agencies and academic institutions have had policies for addressing non-financial interests in grant peer review and research oversight since the 1990s, scientific journals have been only recently begun to develop such policies. An impediment to the formulation of effective journal policies is that non-financial interests can be difficult to (...) recognize and define. Journals can overcome this problem by providing guidance concerning the types of non-financial interests that should be disclosed, including direct research interests, direct professional interests, expert testimony, involvement in litigation, holding a leadership position in a non-governmental organization, providing technical or scientific advice to a non-governmental organization, and personal or professional relationships. The guidance should apply to authors, editors, and reviewers. (shrink)

Clinical ethical consultants are subject to an unavoidable conflict of interest. Their work requires that they be independent, but incentives attached to their role chip relentlessly at independence. This that they be independent, is a problem without any solution, but it can at least be ameliorated through careful management.

Aim To ascertain the quantity and nature of gifts and items provided by the pharmaceutical industry in Australia to medical specialists and to consider whether these are appropriate in terms of justifiable ethical standards, empirical research and views expressed in the literature.

Pharmaceutical companies fund the bulk of clinical research that is carried out on medications. Poor outcomes from these studies can have negative effects on sales of medicines. Previous research has shown that company funded research is much more likely to yield positive outcomes than research with any other sponsorship. The aim of this article is to investigate the possible ways in which bias can be introduced into research outcomes by drawing on concrete examples from the published literature. Poorer methodology in (...) industry-funded research is not likely to account for the biases seen. Biases are introduced through a variety of measures including the choice of comparator agents, multiple publication of positive trials and non-publication of negative trials, reinterpreting data submitted to regulatory agencies, discordance between results and conclusions, conflict-of-interest leading to more positive conclusions, ghostwriting and the use of seeding trials. Thus far, efforts to contain bias have largely focused on more stringent rules regarding conflict-of-interest (COI) and clinical trial registries. There is no evidence that any measures that have been taken so far have stopped the biasing of clinical research and it’s not clear that they have even slowed down the process. Economic theory predicts that firms will try to bias the evidence base wherever its benefits exceed its costs. The examples given here confirm what theory predicts. What will be needed to curb and ultimately stop the bias that we have seen is a paradigm change in the way that we treat the relationship between pharmaceutical companies and the conduct and reporting of clinical trials. (shrink)

This paper applies a utilitarian analysis to corporate political donations. Unlike the more common rights-based analyses, it is argued that the optimal policy is the one that best satisfies society’s rational preferences concerning donor influence, adequate financing, donor pressure and the cost of maintaining and enforcing the democratic system. This analysis suggests that a ban is best if it would be generally observed and sufficient financing from other sources is available, otherwise a donation cap is a better option. Further, lobbyists (...) should be banned from donating small gifts and drafting bills for candidates. The impact of disclosure and other risk management mechanisms are also considered. (shrink)

Integrity is a critical determinant of the effectiveness of research organizations in terms of producing high quality research and educating the new generation of scientists. A number of responsible conduct of research (RCR) training programs have been developed to address this growing organizational concern. However, in spite of a significant body of research in ethics training, it is still unknown which approach has the highest potential to enhance researchers’ integrity. One of the approaches showing some promise in improving researchers’ integrity (...) has focused on the development of ethical decision-making skills. The current effort proposes a novel curriculum that focuses on broad metacognitive reasoning strategies researchers use when making sense of day-to-day social and professional practices that have ethical implications for the physical sciences and engineering. This sensemaking training has been implemented in a professional sample of scientists conducting research in electrical engineering, atmospheric and computer sciences at a large multi-cultural, multi-disciplinary, and multi-university research center. A pre-post design was used to assess training effectiveness using scenario-based ethical decision-making measures. The training resulted in enhanced ethical decision-making of researchers in relation to four ethical conduct areas, namely data management, study conduct, professional practices, and business practices. In addition, sensemaking training led to researchers’ preference for decisions involving the application of the broad metacognitive reasoning strategies. Individual trainee and training characteristics were used to explain the study findings. Broad implications of the findings for ethics training development, implementation, and evaluation in the sciences are discussed. (shrink)

In this paper, I discuss the objectivity of science in the context of commercialized research. Objectivity has traditionally been associated with the behavior of individual scientists and their willingness and ability to base their reasoning on data and logic. By introducing some examples of problematic practices in current research, I show that this view is insufficient. A view that I call the Social View on objectivity succeeds better in accommodating the way in which commercialization affects research.

Journal peer review is an essential part of academic practices.1 But how well does it serve its purpose and which factors have an influence on how close it comes to achieving its aims? Peer review has been widely discussed in empirical literature: it has been studied both qualitatively and quantitatively (e.g., by Cole, who in his 1992 book uses data on how grant applications submitted to National Science Foundation were...

ABSTRACT:Evidence abounds that when ethics initiatives are decoupled from the actual work of organizations, ethics policies may become little more than “window dressing” (Weaver, Trevino, and Cochran 1999; Collen and Gonella 2002). We found, however, an unexpected, positive feature of decoupling in the study of a local government; namely, when organizational members engage in discussions that turn away from the letter of an ethics code they often do so to address higher ethical principles embedded in the spirit of the code. (...) The decoupled understanding of the code in these cases becomes a symbolic, legitimating gesture grounded not in strict provisions but in creative and complex interactions. This counterintuitive explanation of decoupling capitalizes on discourse that evolves from a legalistic interpretation to rich discussions that value the multiplicity of voices within organizational life. What follows is that ethical decision making emerges as creative, dynamic, and responsive to its constituents. (shrink)

ABSTRACT:Evidence abounds that when ethics initiatives are decoupled from the actual work of organizations, ethics policies may become little more than “window dressing” (Weaver, Trevino, and Cochran 1999; Collen and Gonella 2002). We found, however, an unexpected, positive feature of decoupling in the study of a local government; namely, when organizational members engage in discussions that turn away from the letter of an ethics code they often do so to address higher ethical principles embedded in the spirit of the code. (...) The decoupled understanding of the code in these cases becomes a symbolic, legitimating gesture grounded not in strict provisions but in creative and complex interactions. This counterintuitive explanation of decoupling capitalizes on discourse that evolves from a legalistic interpretation to rich discussions that value the multiplicity of voices within organizational life. What follows is that ethical decision making emerges as creative, dynamic, and responsive to its constituents. (shrink)

Although there is increased recognition of the inevitable--and perhaps sometimes beneficial-- role of values in scientific inquiry, there are also growing concerns about the potential for commercial values to lead to bias. This is particularly evident in biomedical research. There is a concern that conflicts of interest created by commercialization may lead to biased reasoning or methodological choices in testing drugs and medical interventions. In addition, such interests may lead research in directions that are unresponsive to pressing social needs, when (...) it is profitable to do so. Feminist philosophy of science seems particularly well situated to provide resources to help address such concerns because this literature has both 1) theorized about how to minimize biases in science, e.g., sexist or androcentric biases, and 2) generated accounts of objectivity that do not require individual scientists to be value-neutral or disinterested. Two such accounts are assessed in relation to concerns about commercial bias: those offered by feminist empiricism and standpoint feminism. We argue that standpoint feminism is more promising because it has resources to address, not just the epistemological, but also the inescapably ethical dimensions of commercial bias. (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)

(2010). Response to Open Peer Commentaries on “The Pitfalls of Deducing Ethics from Economics: Why the Association of American Medical Colleges is Wrong About Pharmaceutical Detailing”. The American Journal of Bioethics: Vol. 10, No. 1, pp. W1-W3.

The study examines the attitudes among physicians regarding acceptance of gifts, sponsorships, and drug samples in response to marketing efforts of pharmaceutical companies in India. The research also attempts to study physicians’ perceptions of the Medical Council of India (MCI) guidelines on the code of conduct for pharmaceutical marketing practices and the influence of these guidelines on physicians’ actions. A structured questionnaire was developed for collecting primary data regarding exposure of physicians to promotional tools and physicians’ attitudes and practices with (...) regard to various professional ethical issues. One thousand physicians from private and government hospitals located in a metropolitan area were approached personally or through email for getting the questionnaire filled. A total of 189 completed and usable questionnaires could be obtained which is a response rate of approximately 20 %. Respondents in the study indicate being offered samples, sponsorship, and gifts by pharmaceutical companies with a frequency of at least once a month. Thus, many pharmaceutical firms are not following the code of conduct issued by the Department of Pharmaceuticals, Govt. of India. Further, though almost all physicians report being aware of the guidelines issued by the MCI, yet as many as 69 % of the sample admitted to be accepting gifts and sponsorships offered by the pharmaceutical firms. Educational programs were found to be influencing physician prescription behavior to a greater extent when compared with gifts. Frequency of offers made for gifts and sponsorships were found to be dependent upon physicians’ practice (number of prescriptions written) and the type of hospital they are associated with (private or government). The study focuses on sensitive yet critical ethical issues related to the promotional practices of pharmaceutical firms in India and physicians’ responses with regard to these promotional practices in the context of the guidelines of the Medical Council of India and the Department of Pharmaceuticals. (shrink)

The development of a code of ethics for a profession can be an indicator of the coherence and stability of a discipline as a unique and singular entity. Since “bioethics”, as a discipline, is not one profession but many, practiced by persons with not one but many varying responsibilities and training, it has been argued that no code of ethics is possible for the discipline(s) of bioethics. I argue that a code of ethics is possible for bioethics by looking at (...) the nature of the various disciplines and noting necessary overlap between them, and deriving the ethics from the nature of the discipline(s) themselves. I show how this can be done by arguing that strict rules about funding and conflict of interest are necessary for bioethicists. (shrink)

Biomedical research and its translation continue to pose normative questions about the nature of relations between researcher and participant and the role of research involving human subjects in so...

In contemporary medicine, it is not always obvious whether the acceptance of a benefit constitutes a conflict of interest. A particular area of controversy has been the impact of small gifts or other benefits from pharmaceutical companies on physicians' behaviour. Typically, in such cases, the gift is not an explicit reward for cooperation; the physician does not perceive the gift as an attempt to influence his or her judgement; and the reward is relatively minor. Under these circumstances, physicians are generally (...) of the view that acceptance of gifts will not affect their behaviour, notwithstanding findings from social psychology and neuroscience that the impact of gifts is often unconscious, shaping action without a person's awareness. Here, we draw on traditional texts of Jewish law pertaining to the prohibition of taking a gift to illustrate recognition by the ancients of unconscious conflicts of interest, and their approach to dealing with the problem. (shrink)

The purpose of this chapter is to describe what we see as several important new directions for philosophy of medicine. This recent work (i) takes existing discussions in important and promising new directions, (ii) identifies areas that have not received sufficient and deserved attention to date, and/or (iii) brings together philosophy of medicine with other areas of philosophy (including bioethics, philosophy of psychiatry, and social epistemology). To this end, the next part focuses on what we call the “epistemological turn” in (...) recent work in the philosophy of medicine; the third part addresses new developments in medical research that raise interesting questions for philosophy of medicine; the fourth part is a discussion of philosophical issues within the practice of diagnosis; the fifth part focuses on the recent developments in psychiatric classification and scientific and ethical issues therein, and the final part focuses on the objectivity of medical research. (shrink)

Moral philosophers of late have been examining the implications of experimental social psychology for ethics. The focus of attention has been on situationism—the thesis that we routinely underestimate the extent to which minor situational variables influence morally significant behavior. Situationism has been seen as a threat to prevailing lay and philosophical theories of character, personhood, and agency. In this paper, I outline the situationist literature and critique one of its upshots: the admonition to carefully select one’s situational contexts. Besides being (...) limited in application, this strategy accentuates an untenable person/situation dichotomy. The deeper lesson of situationism lies in highlighting the interconnectedness of all social behavior—how we are inextricably involved in the actions of others, and how minor tweaks in our own behavior can lead to major payoffs in our moral lives. Situationism is better seen as an opportunity for moral progress than a threat to individual autonomy. (shrink)