Lack of vaccine confidence can contribute to drops in vaccination coverage and subsequent outbreaks of diseases like measles and polio. Low trust in vaccines is attributed to a combination of factors, including lack of understanding, vaccine scares, flawed policies, social media and mistrust of vaccine manufacturers, scientists and decision-makers. The COVID-19 crisis has laid bare societies’ vulnerability to new pathogens and the critical role of vaccines in containing this and future pandemics. It has also put science at the forefront of (...) the response, with several governments relying on academics to help shape policy and communicate with the public. Against this backdrop, protecting public trust in scientists and scientific output is arguably more important than ever. Yet, conflicts of interest in biomedical research remain ubiquitous and harmful, and measures to curb them have had limited success. There is also evidence of bias in industry-sponsored vaccine studies and academics are voicing concerns about the risks of working in a CoI prevalent research area. Here, we set out to challenge established thinking with regard to vaccine confidence, by shifting the gaze from a deficit in public understanding towards probity in research relationships and suggesting an alternative and perhaps complementary strategy for addressing vaccine mistrust. We argue that a concerted effort needs to be made to revisit the norms that undergird contemporary vaccine research, coupled with a willingness of all stakeholders to reimagine those relationships with an emphasis on demonstrating trustworthiness and probity. (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)

Developing and applying a framework for understanding the complexities of economic and legal considerations in two recent Supreme Court rulings was the focus of this research. Of especial concern was the protection of intellectual property in the pharmaceutical industry. Two cases from 2013 were selected: FTC v. Activis and Association for Molecular Pathology v. Myriad Genetics, Inc.. Part of the rationale for the selection was the importance of the Supreme Court rulings and the importance of the pharmaceutical sector. A qualitative (...) content analysis of the Court’s reported decision in each case was analyzed. Since ethical considerations may or may not be consistent with efficiency considerations of plaintiffs, defendants, or the courts, both efficiency and ethical arguments were included. Equally important to the understanding of the economic and ethical issues in the two above- mentioned cases was the development of a rationale for including and excluding a variety of ethical theories, ultimately influenced by Markkula Center For Applied Ethics Of Santa Clara University and Schumann :93–111, 2001). The refinement and use of a levels analysis approach portrays societal, organizational, and individual impacts, and allows for deeper understanding of litigated cases, irrespective of the country in which the litigation takes place :385–393, 2004; Foss et al., J Manag Stud 47:455–482, 2010). A rationale for this framework is the societal and organizational impacts on the myriad of stakeholders in the pharmaceutical sector. We suggest that this framework can be applied to other industries and other complex conflicts among stakeholders as well. (shrink)

Gifts have served as a fundamental aspect of the human experience across time, even as their precise roles and functions have shifted. In the past, bioethicists and others have drawn upon anthropol...

Patient visits are an important opportunity for general practitioners to discuss the risks of smoking and cessation strategies. In Australia, the guidelines on cessation published by the Royal Australian College of General Practitioners represent a key resource for GPs in this regard. The predominant message of the Guidelines is that pharmacotherapy should be recommended as first-line therapy for smokers expressing an interest in quitting. This, however, ignores established evidence about the success of unassisted quitting. Our analysis of the Guidelines identifies (...) a number of potential conflicts of interest which may have affected the advice provided. These include extensive funding by the pharmaceutical industry of sources cited to support the recommendations, and relations between members of the Guidelines Content Advisory Group and the pharmaceutical industry. Recommendations issued by professional bodies have enormous potential impact upon public health and there is a need for the highest levels of scrutiny and transparency in their development. Information about research cited in guidelines should include funding sources, and developers should be free of obvious conflicts of interest. Smoking remains the leading preventable cause of global mortality. Concerns related to pharmaceutical industry funding of research, scientific integrity and recommendations on smoking cessation by medical advisory groups clearly have implications beyond Australia. (shrink)

ABSTRACT Although scholars have long been interested in distinguishing gift giving from bribery, the impact of the degree of guanxi between a giver and a recipient on this distinction remains unclear. Drawing on a bystander perspective, this paper investigates how people distinguish between two types of giving behavior: gift giving and bribing. In three studies, we examined how guanxi, the price of a present, and the motivation for giving a present influence people’s perception of a present. The results largely supported (...) our expectation that presents were more likely to be considered a bribe when guanxi utility was high, if the present held high economic value, and if the giving motivation was instrumental-oriented. Implications of our findings for future research and business practitioners in Chinese culture are discussed. (shrink)

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.

Financial and nonfinancial conflicts of interest in medicine and surgery are troubling because they have the capacity to skew decision making in ways that might be detrimental to patient care and well-being. The recent case of the Articular Surface Replacement (ASR) hip provides a vivid illustration of the harmful effects of conflicts of interest in surgery.

Sponsorship of medical conferences by the pharmaceutical industry has led to many ethical issues, especially in resource-poor developing countries. The core issue in these instances is to reduce or avoid conflicts of interests. COI is a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by secondary interests. Disruption of social trust should also be considered. This deontological approach should be complemented by a consequentialist approach. Towards this, the concept (...) ofdistal interests is introduced. DI lies beyond the immediately visible COIs and the consequences of immediate decisions. They are ‘distal’ in time or place: ‘DI in time’ means consequence of the decision in future scenarios, while ‘DI in space’ means those that impinge on other institutions or bodies. In judging the consequences, it is also necessary to consider the reality of the existing relationship between the pharmaceutical industry and organisers of conferences. In more developed countries, these relationships are governed by stricter regulations, adherence to codes of conduct by both parties and stronger institutional oversights. In contrast, developing countries such as Sri Lanka the regulatory environment is lax and the demarcation of interests between the pharmaceutical industry and the medical profession is considerably blurred. Therefore, establishing clear rules of engagement between the stakeholders should be considered as an attempt to clear the muddy waters. The paper proposes a set of guidelines to capture these approaches. (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)

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)

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...

The success of precision medicine depends on obtaining large amounts of information about at-risk populations. However, getting consent is often difficult. Why? In this commentary I point to the differentials in social status involved. These differentials are inevitable once personal information is surrendered, but are particularly intense when the studied populations are socioeconomically or socioculturally disadvantaged and/or ethnically stigmatized groups. I suggest how the deep distrust of the latter groups can be partially justified as a lack of confidence that their (...) core values or interests will sufficiently be taken into account. Hence, the ethical challenge here lies not in avoiding status differentials, but in dealing with them appropriately. Scientists should not assume trust from others but adopt a norm of “demonstrating trustworthiness”. (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)