This special JLME symposium addresses ways that federal policy can incentivize innovation in medical therapeutics and make pharmaceuticals more financially accessible.

Most pharmaceutical research carried out today is focused on the treatment and management of the lifestyle diseases of the developed world. Diseases that affect mainly poor people are neglected in research advancements in treatment because they cannot generate large financial returns on research and development costs. Benefit sharing arrangements for the use of indigenous resources and genetic research could only marginally address this gap in research and development in diseases that affect the poor. Benefit sharing as a strategy is (...) conceptually problematic, even if one, as we do, agrees that impoverished indigenous communities should not be exploited and that they should be assisted in improving their living conditions. The accepted concept of intellectual property protection envisages clearly defined originators and owners of knowledge, whereas the concept of community membership is fluid and indigenous knowledge is, by its very nature, open, with the originator(s) lost in the mists of time. The delineation of ‘community’ presents serious conceptual and practical difficulties as few communities form discrete, easily discernable groups, and most have problematic leadership structures. Benefit sharing is no substitute for governments’ responsibility to uplift impoverished communities. Benefit sharing arrangements may be fraught with difficulties but considerations of respect and equity demand that prior informed consent and consultation around commercialisation of knowledge take place with the source community and their government.1. (shrink)

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)

ABSTRACT Most pharmaceutical research carried out today is focused on the treatment and management of the lifestyle diseases of the developed world. Diseases that affect mainly poor people are neglected in research advancements in treatment because they cannot generate large financial returns on research and development costs. Benefit sharing arrangements for the use of indigenous resources and genetic research could only marginally address this gap in research and development in diseases that affect the poor. Benefit sharing as a strategy (...) is conceptually problematic, even if one, as we do, agrees that impoverished indigenous communities should not be exploited and that they should be assisted in improving their living conditions. The accepted concept of intellectual property protection envisages clearly defined originators and owners of knowledge, whereas the concept of community membership is fluid and indigenous knowledge is, by its very nature, open, with the originator(s) lost in the mists of time. The delineation of ‘community’ presents serious conceptual and practical difficulties as few communities form discrete, easily discernable groups, and most have problematic leadership structures. Benefit sharing is no substitute for governments’ responsibility to uplift impoverished communities. Benefit sharing arrangements may be fraught with difficulties but considerations of respect and equity demand that prior informed consent and consultation around commercialisation of knowledge take place with the source community and their government.1. (shrink)

This study is based on the natural resource based view, which examines the impact of holistic marketing orientation on business performance by defining the role of enablers and mediators. The drivers, including corporate social responsibility and environmental culture influence, are tested by analyzing the role of sustainable competitive advantage as a mediator. The analysis is based on 298 samples collected from top and middle-level managers working in the pharmaceutical industry. Structural equation modeling was undertaken using Smart PLS 3.2.8. The (...) research outcomes reveal that corporate social responsibility and environmental culture have a substantial impact on green marketing orientation. The results show that GMO has a significant direct and indirect impact on business performance while a full mediation of sustainable competitive advantage exists between the green marketing orientation and business performance. The outcomes will facilitate managers in green marketing strategy and decision making in the long-term, with 3-fold benefits in addition to strengthening their competitiveness. (shrink)

It is by now no secret that some scientific articles are ghost authored – that is, written by someone other than the person whose name appears at the top of the article. Ghost authorship, however, is only one sort of ghosting. In this article, we present evidence that pharmaceutical companies engage in the ghost management of the scientific literature, by controlling or shaping several crucial steps in the research, writing, and publication of scientific articles. Ghost management allows the (...) class='Hi'>pharmaceutical industry to shape the literature in ways that serve its interests.This article aims to reinforce and expand publication ethics as an important area of concern for bioethics. Since ghost‐managed research is primarily undertaken in the interests of marketing, large quantities of medical research violate not just publication norms but also research ethics. Much of this research involves human subjects, and yet is performed not primarily to increase knowledge for broad human benefit, but to disseminate results in the service of profits. Those who sponsor, manage, conduct, and publish such research therefore behave unethically, since they put patients at risk without justification. This leads us to a strong conclusion: if medical journals want to ensure that the research they publish is ethically sound, they should not publish articles that are commercially sponsored. (shrink)

It is by now no secret that some scientific articles are ghost authored – that is, written by someone other than the person whose name appears at the top of the article. Ghost authorship, however, is only one sort of ghosting. In this article, we present evidence that pharmaceutical companies engage in the ghost management of the scientific literature, by controlling or shaping several crucial steps in the research, writing, and publication of scientific articles. Ghost management allows the (...) class='Hi'>pharmaceutical industry to shape the literature in ways that serve its interests. This article aims to reinforce and expand publication ethics as an important area of concern for bioethics. Since ghost-managed research is primarily undertaken in the interests of marketing, large quantities of medical research violate not just publication norms but also research ethics. Much of this research involves human subjects, and yet is performed not primarily to increase knowledge for broad human benefit, but to disseminate results in the service of profits. Those who sponsor, manage, conduct, and publish such research therefore behave unethically, since they put patients at risk without justification. This leads us to a strong conclusion: if medical journals want to ensure that the research they publish is ethically sound, they should not publish articles that are commercially sponsored. (shrink)

Prescribing drugs for uses that the FDA has not approved — off-label drug use — can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address (...) the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers’ conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use. (shrink)

Pharmacy Benefit Managers (PBM) induce drug manufacturers to offer rebates to insurers and employers by denying coverage through formulary exclusions, impeding physician prescription through prior authorization, and reducing patient drug use through cost sharing. As they tighten these access obstacles, PBMs reduce the net prices received by the manufacturers.

The paper explores a case of partnership between a large pharmaceutical company and a national charity in the United Kingdom, a partnership from which the drug company sought improved public relations, and the charity money. Neither side was able to accept this reality. Managers of the partnership insisted that its only purpose was to improve the lifestyle of teenagers. They were supported by a literature on partnership that also tends to ignore the distinction between the task the partnership is (...) set and its fundamental purpose. While much is made of the benefits of partnership, there are likely to be costs, both private and social, associated with failure to admit the purpose of partnership. (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)

Recently, Congress has focused on reforms to address pharmacy benefit managers’ (PBMs) role in high drug prices for patients. Congress must not excessively restrict PBMs’ ability to negotiate with manufacturers; alternatively, reforms could be paired with other policies that address the high prices of brand-name drugs.

Every pharmacist, aware or not, is constantly making ethical choices. Sometimes these choices are dramatic, life-and-death decisions, but often they will be more subtle, less conspicuous choices that are nonetheless important. Assisted suicide, conscientious refusal, pain management, equitable and efficacious distribution of drug resources within institutions and managed care plans, confidentiality, and alternative and non-traditional therapies are among the issues that are of unique concern to pharmacists. One way of seeing the implications of such issues and the moral choices they (...) pose is to look at the experiences of practitioners and the kinds of choices they have had to make in situations typically faced by pharmacists. This book is a collection of those situations based on the real experiences of practicing pharmacists. The use of case studies in health care ethics is not new, but in pharmacy it is. This text is an important teaching tool that will help pharmacy students and pharmacists address the increasing number of ethical problems arising in their profession. It is not merely a compilation of cases, but rather is organized for the systematic study of applied ethics. Part I shows how to distinguish ethical problems from other kinds of evaluative judgments and examines the sources of values in pharmacy, posing basic questions about the meaning and justification of ethical claims. Part II explores the basic principles of ethics as they have an impact on pharmacy. Specific cases from clinical settings present in a systematic way the various questions raised by each of the major ethical principles -- benefiting the patient, distributing resources justly, respecting autonomy, dealing honestly with patients, keeping promises of confidentiality, and avoiding harm. Part II examines some of the special problems of contemporary pharmacy such as the linkages between pharmaceutical care and professional practice, human experimentation, reproductive issues, genetic technology, death and dying, and mental health. (shrink)

Drug regulation is fraught with inductive risk. Regulators must make a prediction about whether or not an experimental pharmaceutical will be effective and relatively safe when used by typical patients, and such predictions are based on a complex, indeterminate, and incomplete evidential basis. Such inductive risk has important practical consequences. If regulators reject an experimental drug when it in fact has a favourable benefit/harm profile, then a valuable intervention is denied to the public and a company’s material interests are (...) needlessly thwarted. Conversely, if regulators approve an experimental drug when it in fact has an unfavourable benefit/harm profile, then resources are wasted, people are needlessly harmed, and other potentially more effective treatments are underutilized. Given that such regulatory decisions have these practical consequences, non-epistemic values about the relative importance of these consequences impact the way such regulatory decisions are made (similar to the analysis of laboratory studies on the toxic effects of dioxins presented in Douglas [2000]). To balance the competing demands of the pertinent non-epistemic values, regulators must perform what I call an “inductive risk calculus.” At least in the American context this inductive risk calculus is not well-managed. (shrink)

Photo ID 279661800 © Sidewaypics|Dreamstime.com ABSTRACT Decolonization is complex, vast, and the subject of an ongoing academic debate. While the many efforts to decolonize or dismantle the vestiges of colonialism that remain are laudable, they can also reinforce what they seek to end. For decolonization to be impactful, it must be done with epistemic and cultural humility, requiring decolonial scholars, project leaders, and well-meaning people to be more sensitive to those impacted by colonization and not regularly included in the discourse. (...) INTRODUCTION Decolonization is complex. To successfully achieve decolonization, projects should incorporate the voices of those subjugated or silenced. Including such voices requires sincerely exploring who has been affected by colonialism or neocolonialism and how, as well as cultural sensitivity. In its basic use, decolonization refers to countries under colonial rule gaining independence or freedom from forms of subjugation. Additionally, scholars use the term to refer to efforts to dismantle neocolonialism and vestiges of colonialism. The process includes de-silencing subjugated voices.[1] I use decolonization in the latter way to refer to countries with technical independence. While arguably colonization ended formally with independence from colonizing powers, neocolonialism is the indirect, informal, and sometimes subtle control of the people, their economy, and political life despite formal independence from colonizing authorities. I conceptualize neocolonialism as a system that involves direct and involuntary control of another’s political, economic, or social life, impacting their worldview and ways of encountering the world. Decolonization may target actions, places, or systems like health care or AI to overcome the ills of colonialism and neocolonialism. It also may target knowledge and require rethinking how people develop their knowledge base. For example, if people grew up seeing an outside colonizer as superior, they would need to change their knowledge of superiority. Decolonization may target power, for example, changing who owns and distributes COVID-19 vaccines and who distributors exclude in the distribution of vaccines. Decolonization could require looking at those disempowered in the distribution process. Additionally, decolonization may target autonomy of persons by freeing people, ensuring human and individual rights, and respecting cultural traditions. Decolonization projects that try to de-silence by including the voices of those affected by colonialism and neocolonialism must examine inclusiveness in the context of the culture of the subrogated individuals. Examples of decolonization projects include making datasets inclusive of diverse peoples and places, returning to traditional food and eating practices, making sure hospitals in developing countries are led by locals and respectful of cultural traditions, returning unethically obtained artefacts or objects. Another project would be laying the groundwork for equality in formerly colonized countries to ensure that business ownership, education, and financial success will flow fairly to those previously victimized by colonization. Summarily, there are many strategies for decolonizing. However, it is worth asking whether the strategies have risks that undermine the goal of decolonization. I. Understanding Decolonization Discourses Many fields, from AI to politics, economics, health care, aviation, and academia, discuss decolonization. The content of the discourse on decolonization depends on the region and field discussing it. Rather than just reporting on decolonization, the discussions may be calls to action. For example, decolonization discourses reflect activism for cognitive justice, such as equal consideration of Indian or African knowledge systems in global health discourses.[2] In politics and political science, some scholars frame decolonization as an anti-western, anti-colonial movement by Africans to emancipate Africa/ns from subjugation or shift the continent to postcolonialism and post-neo-colonialism. This framing walls off non-African participants and may undermine their capacity to benefit the conversation.[3] There are other political scientists who actively support decolonization and see it as a field of activism in support of anyone and countries where colonization harmed people and development.[4] The point is that two ways of conceptualizing decolonization in politics and political science are discernible. One conceptualization is less inclusive since it alienates scholars and professionals from Western, high-income, or developed countries. The other is more inclusive. In humanitarian studies, including philosophy, some decolonization articles and conversations are efforts to end the destructive force of colonization. They focus on either the form, such as ecocide, genocide, and many others, or the geographic location, such as Africa, Asia, Latin America, and Oceania.[5] Finally, the feelings one brings into this conversation can adversely impact how one engages in them and who they listen to or are willing to hear from. For example, anger, rage, bitterness, and hatred are emotions that are not uncommon in spaces of decolonization conversations. Decolonization conversations that originate from a place of negativity risk deepening the psychological state of victimhood and prevent people from disrupting constructively or critically engaging in the conversation.[6] II. Understanding Decolonization Strategies Decolonization strategies mainly aim to de-silence victims of domination or subjugation. People have proposed many strategies for decolonizing. These strategies may be informed by what the target is for decolonization. Decolonization can target power relations in global health. For example, during the COVID-19 pandemic, public health organizations noted the power imbalance in vaccine distribution. Decolonization could involve de-silencing those affected by neocolonialism to bring about a more balanced distribution of power and a more fair distribution of the vaccine. By analyzing who was adversely impacted by the distribution and who ought to wield power, those engaged in decolonizing advocated for positive change and equitable power relations. Equally, when being is the target of decolonization, the language of unlearning or relearning and mental decolonization take centre stage in the decolonization discourse. For example, the quest to decolonize colonized minds aims to demythologize African inferiority and Western superiority. Demythologizing African inferiority enables those engaged in the decolonization discourse to cultivate and foster African agency.[7] Finally, when knowledge production is the target of decolonization, scholars use inclusion and cognitive justice. For example, they try to alter the knowledge that underlies global health ethics.[8] “[D]decolonizing researchers aim to respectfully understand and integrate theory from Other(ed) perspectives, while also critically examining the underlying assumptions that inform their Western research framework.”[9] One common strategy that scholars use in decolonization is inclusion. It is worth asking, does including people who have been subrogated foster decolonization? Whether that is effective depends on whether included people are more heard or whether the strategies to include them create new forms of silencing. III. Inclusion and the Quest to Decolonize Evaluating how effective inclusion is in the quest to de-silence subjugated voices is important. First, inclusive strategies are not neutral. They are epistemically situated. This situatedness constrains meaning-making in different ways: how and what questions are asked, how social roles are constructed, organized or assigned, and who is admitted to the room where these conversations occur.[10] Inclusion strategies may reinforce (unchallenged) assumptions. For example, to address prejudices and stereotypes in global health images, Arsenii Alenichev and his colleagues[11] successfully inverted “one stereotypical global health image” by prompting a generative AI to produce “an image of a traditional Indian or African healer healing a White Child.” Although there were some problems with the image of the White child, this innovation is a significant, useful effort to de-embed or strip global health images of problematic pictures that mythologize White superiority and Black inferiority. Yet it is possible that using categories like traditional Indian or African reinforces unchallenged assumptions, raising key questions regarding how language and words create new stereotypes. It is common to define traditional as non-conventional, unorthodox, and informal. Yet studies continue to reveal that non-scientifically appraised healing approaches in India or Africa are not only effective but also real, meaningful, fundamental, and primary care-seeking behaviours in many communities in these regions.[12] Suppose inclusive strategies are not un-situated. These conversations may be had within the structures, language, and spaces built by or connected to colonialism. The spaces, language, places, and structures in which these conversations occur can limit who can participate and how they participate. Importantly, some conditions are not conducive to participation as equals. The allocated time for the discussion could also constrain how individuals express themselves. It is unclear who is ultimately heard. Furthermore, epistemic situatedness of inclusion can impact decolonization conversations when participants are beneficiaries of, products of, and trained by structures and systems they seek to dismantle. To enhance the decolonization project and its goals, a pressing task is to unveil and question how the circumstances may inhibit activism. If the vestiges of colonialism continue to structure the decolonization discourse invisibly, the vestiges may undermine decolonization. For example, a public health discussion that includes white Western doctors and Western pharmaceutical executives in Africa may have many local Africans at the table but could still effectively devalue their input based on built-in assumptions and biases that are vestiges of colonialism. Second, exclusion and inclusion are also not binary. Individuals may experience exclusion, even while included (the phenomenon called internal exclusion). In other words, inclusion can fail to be substantial or become a means of enhancing optics, “a way of (un)consciously weakening the radical claims being pursued.”[13] For example, in South Africa, many institutions have made significant efforts to diversify their faculties due to the promulgation of the Employment Equity Act 55.[14] The act requires South African institutions to implement employment equity that redresses the history of harmful discrimination in the country. The act further requires transforming departments and institutional administrations. Although many recognize and support the need to transform departments in South Africa, the rhetoric of transformation departs sharply from the lived experiences.[15] This misalignment between the plan and practice is evident in the underrepresentation of black people and females in senior management teams, professorships in many universities and health departments, and positions of power in some South African institutions. Those selected in the transformation of the departments have also complained of being overworked. The burden of extra work undermines their ability to develop agency and voice in the space they now occupy or fulfil key requirements that have implications for their career trajectory.[16] This is called the minority tax. Notably, "the minority tax… is the burden of extra responsibilities [placed] on faculty of colour to achieve diversity and inclusion and contributes to attrition and impedes academic promotion."[17] One challenge for decolonializing projects will be for decolonial scholars and those selected for decolonization objectives to have the humility to decline invitations, requests, roles, and platforms for which they are either unqualified or lack the capacity to fulfil. At its heart, decolonization strategies must empower those included rather than weaken them. Finally, inclusion can lead to a phenomenon known as elite capture.[18] Elite capture occurs when socially advantaged individuals in a group monopolize or exploit activism to their own benefit at the expense of the larger, struggling group. Elite capture weakens decolonization efforts from within, revealing that those likely to benefit from global inclusive efforts are those who fulfil globally constructed standards, those “already present in the room.” There is no better strategy to weaken decolonial movements than weakening the project from within by strategically positioning individuals who share physical properties with the victims of exclusion and silencing but intellectually, behaviourally, psychologically, and emotionally share more common ground with the colonizer. Such insiders may be unaware they are furthering neocolonial conditions rather than decolonizing. In relation to decolonization, particularly in global health, elite capture reveals that those whose voices are loudest in the room are not necessarily those more impacted by colonialism. They may benefit more from reinforcing colonialism. Opportunism weakens meaningful activism from within, preventing good initiatives and strategies from having their intended impact or taking substantive root.[19] This paper cannot do justice to elite capture, but it is worth noting its negative impacts. IV. Improving the Impact of Decolonization To end neo-colonialism, it is important to understand how it manifests and what to do at each level. Beyond the academic discourse, many tangible efforts exist to decolonize through de-silencing. Examples of these efforts include the ME2 movement that seeks to centre the concerns and experiences of sexually abused or harassed victims in the public discourse. At the funding level, many grant-awarding agencies like Wellcome Trust have dedicated huge budgets to studies that help them understand how they may have perpetrated colonialism or neocolonialism and what they can do differently going forward.[20] In South Africa, promulgating the Employment Equity Act 55 was a tangible attempt to entrench decolonization concerns in a country's regulatory framework. Yet, these decolonization efforts could fail to be substantive if they do not reflect cultural sensitivity. Two key components of cultural sensitivity are worth highlighting here: epistemic and cultural humility. Epistemic humility is an intellectual virtue described as knowing one’s limitations and the limitations of the learning methods employed. At its simplest, it is the ability to admit when one is wrong. Cultural humility includes genuine attempts to learn about and embrace other cultures. Epistemic and cultural humility are signs of academic excellence and strength. Epistemic and cultural humility seriously acknowledge how the state of our knowledge, cognitive limitations, experiences, and backgrounds, while constraining us, also invite us to listen, learn, grow, and change. The limitations-owing account of epistemic and cultural humility suggests that “a person who is aware of her cognitive limitations and owns them is much better positioned to achieve such epistemic goods as true beliefs and understanding than someone who… simply has insight into the epistemic status of her beliefs.”[21] Epistemic and cultural humility may help prevent decolonization projects that unintentionally reinforce what they seek to dismantle. Epistemic humility calls on decolonizers to defer tasks for which they are not qualified to suitably qualified persons. Beyond this, humility supports brave scholarship that imagines and reimagines how featuring the same voices, faces, and perspectives possibly introduces new forms of domination or silencing. Cultural knowledge can lead to a more intentional way of seeking out the right people or a more diverse group than those frequently featured in decolonization conversations. This would give others more opportunities to navigate these spaces and should do so in ways that are familiar to them. One ought to be more sensitive to those who would ordinarily not be included in these conversations. Unless we radically and boldly reimagine these discussions, we risk alienating those most negatively impacted by neocolonialism. CONCLUSION Decolonization conversations are complex and the subject of academic debate. The strategies employed to decolonize can harm or help the victims of neo-colonialism. Inclusion of previously silenced individuals may not be enough to overcome the vestiges of colonialism, leading to a false inclusion, where those included feel excluded or contribute in ways reflecting their own biases and circumstances. Inclusion of an elite or people who do not truly represent the subjugated can lead to elite capture. For decolonization strategies to be impactful, for example, in the context of global health, project leaders and participants must engage in conversations employing epistemic and cultural humility. In many ways, epistemic and cultural humility can help us demythologize our assumptions of any cultural superiority or cognitive authority, allowing for diverse voices, cultures, and perspectives to emerge without domination. - [1] Caesar Atuire & Olivia Rutazibwa. 2021. An African Reading of the Covid-19 Pandemic and the Stakes of Decolonization. An African Reading of the Covid-19 Pandemic and the Stakes of Decolonization [Online]. Available from: https://law.yale.edu/yls-today/news/african-reading-covid-19-pandemic-and-stakes-decolonization [Accessed July 29, 2021 2021]. [2] Bridget Pratt & Jantina De Vries 2023. Where is knowledge from the Global South? An account of epistemic justice for a global bioethics. Journal of Medical Ethics, medethics-2022-108291. [3] Anye-Nkwenti Nyamnjoh 2023. Is decolonisation Africanisation? The politics of belonging in the truly African university. Social Dynamics, 1-20. [4] Rianna Oelofsen 2015. Decolonisation of the African mind and intellectual landscape. Phronimon, 16, 130-146. [5] Caesar Atuire & Olivia Rutazibwa. 2021. An African Reading of the Covid-19 Pandemic and the Stakes of Decolonization. An African Reading of the Covid-19 Pandemic and the Stakes of Decolonization [Online]. Available from: https://law.yale.edu/yls-today/news/african-reading-covid-19-pandemic-and-stakes-decolonization [Accessed July 29, 2021 2021]. [6] Pedro Alexis Tabensky 2008. The Postcolonial Heart of African Philosophy. South African Journal of Philosophy, 27, 285-295. [7] Nicholas M. Creary 2012. African Intellectuals and Decolonization, Ohio, Ohio University Press. [8] Bridget Pratt & Jantina De Vries 2023. Where is knowledge from the Global South? An account of epistemic justice for a global bioethics. Journal of Medical Ethics, medethics-2022-108291. [9] Vivetha Thambinathan & Elizabeth Anne Kinsella 2021. Decolonizing Methodologies in Qualitative Research: Creating Spaces for Transformative Praxis. International Journal of Qualitative Methods, 20, 16094069211014766. [10] Abimbola Seye 2023. Knowledge from the global South is in the global South. Journal of Medical Ethics, 49, 337. [11] A. Alenichev, P. Kingori & K. P. Grietens 2023. Reflections before the storm: the AI reproduction of biased imagery in global health visuals. Lancet Glob Health. [12] Jonathan K. Burns & Andrew Tomita 2015. Traditional and religious healers in the pathway to care for people with mental disorders in Africa: a systematic review and meta-analysis. Social Psychiatry and Psychiatric Epidemiology, 50, 867-877. [13] Anye-Nkwenti Nyamnjoh & Cornelius Ewuoso 2023. What type of inclusion does epistemic injustice require? Journal of Medical Ethics, jme-2023-109091. [14] 1998. Employment Equity Act. In: GOVERNMENT, S. A. (ed.) 19370. [15] Dina Zoe Belluigi & Gladman Thondhlana 2019. ‘Why mouth all the pieties?’ Black and women academics’ revelations about discourses of ‘transformation’ at an historically white South African university. Higher Education, 78, 947-963. [16] Juliet Ramohai & Khomotso Marumo 2016. Women in Senior Positions in South African Higher Education: A Reflection on Voice and Agency. 231, 135-157. [17] J. Trejo 2020. The burden of service for faculty of color to achieve diversity and inclusion: the minority tax. Mol Biol Cell, 31, 2752-2754. [18] Olufemi Taiwo 2020. Being-in-the-Room Privilege: Elite Capture and Epistemic Deference. The Philosopher, 108, 7. [19] Margarita Kurbatova & Elena Kagan 2016. Opportunism of University Lecturers As a Way to Adaptate the External Control Activities Strengthening. Journal of Institutional Studies, 8, 116-136. [20] Jeremy Farrar. 2022. An update on Wellcome's anti-racist programme. An update on Wellcome's anti-racist programme [Online]. Available from: https://wellcome.org/news/update-wellcomes-anti-racism-programme [Accessed August 10, 2022 2022]. [21] Katherine Dormandy 2018. Does Epistemic Humility Threaten Religious Beliefs? Journal of Psychology and Theology, 46, 292-304. (shrink)

Anecdotes have shown that some articles on profitable drugs are constructed by and shepherded through publication by pharmaceutical companies and their agents, whose influence is largely invisible to readers. This is ghost-management, the substantial but unrecognized research, analysis, writing, editing and/or facilitation behind publication. Publicly available documents suggest that these practices extremely widespread affecting up to 40% of clinical trial reports in key periods but it has been unclear how representative these documents are. This article presents the results of (...) an investigative sampling of the self-presentation of publication planning services, and presents this and other evidence of a sizable publication planning industry. Thus different lines of evidence indicate that ghost-management is a common and important phenomenon, strongly affecting the published medical literature in the service of marketing. (shrink)

Risk communication has been generally categorized as a warning act, which is performed in order to prevent or minimize risk. On the other side, risk analysis has also underscored the role played by information in reducing uncertainty about risk. In both approaches the safety aspects related to the protection of the right to health are on focus. However, it seems that there are cases where a risk cannot possibly be avoided or uncertainty reduced, this is for instance valid for the (...) declaration of side effects associated with pharmaceutical products or when a decision about drug approval or retirement must be delivered on the available evidence. In these cases, risk communication seems to accomplish other tasks than preventing risk or reducing uncertainty. The present paper analyzes the legal instruments which have been developed in order to control and manage the risks related to drugs – such as the notion of “development risk” or “residual risk” – and relates them to different kinds of uncertainty. These are conceptualized as epistemic, ecological, metric, ethical, and stochastic, depending on their nature. By referring to this taxonomy, different functions of pharmaceutical risk communication are identified and connected with the legal tools of uncertainty management. The purpose is to distinguish the different functions of risk communication and make explicit their different legal nature and implications. (shrink)

Pharmaceutical companies routinely engage physicians, particularly those with prestigious academic credentials, to deliver “educational” talks to groups of physicians in the community to help market the company's brand-name drugs.Although presented as educational, and even though they provide educational content, these events are intended to influence decisions about drug selection in ways that are not based on the suitability and effectiveness of the product, but on the prestige and persuasiveness of the speaker. A number of state legislatures and most academic (...) medical centers have attempted to restrict physician participation in pharmaceutical marketing activities, though most restrictions are not absolute and have proven difficult to enforce. This article reviews the literature on why Speakers' Bureaus have become a lightning rod for academic/industry conflicts of interest and examines the arguments of those who defend physician participation. It considers whether the restrictions on Speakers' Bureaus are consistent with principles of academic freedom and concludes with the legal and institutional efforts to manage industry speaking. (shrink)

In 2008 New Zealand's pharmaceutical management agency, PHARMAC, made its final decision on the funding of trastuzumab (Herceptin) for HER2-positive early stage breast cancer. PHARMAC declined to fund the 12-month Herceptin regimen requested by the drug's manufacturer, funding instead a 9-week treatment regimen. The decision was justified on the grounds that there was insufficient evidence of additional long-term health benefits from the longer treatment course, which, coupled with the high cost of the drug, did not make the 12-month (...) regimen sufficiently cost-effective. This paper examines the criticism of PHARMAC's decision that ultimately led to the government's decision to expand the health budget in order to fund the 12-month regimen. It defends PHARMAC's decision against the charge of unfairness, arguing that for high-cost drugs with limited proven effectiveness it is not unfair to deny funding on grounds of cost-effectiveness, since although some moral priority must be given to helping those with serious diseases like breast cancer, the capacity of such drugs to swamp health care budgets is itself a significant moral issue. It concludes that the decision to expand the health budget to pay for Herceptin exacerbates rather than solves the political and moral problems involved in prioritizing health care resources. (shrink)

Indonesia consists of more than 17,000 islands separated for hundreds of thousands of years making both the biodiversity and culture diverse. Strong connection between people and biodiversity form a vast array of traditional knowledges retaliated to the conservation and use of biological diversity. During the last 3 decades, tremendous advancement on science and technology has been able to uncover the intrinsic value of biodiversity. Many lead chemical compounds have been isolated and identified, and has opened up huge opportunities in developing (...) new business based on biodiversity. International cooperation between Japan and Indonesia successfully isolated more than 1,000 species of actinomycetes from diverse ecosystems and more than 30% are new species. This group of microbe is important for future pharmaceutical industries. The consciousness on intrinsic value of biodiversity is, however, only being understood by countries having high science and technology capacity. The intrinsic value of biodiversity remains abstract to most of the people in the developing and less developed nations. The Convention on Biological Diversity (UN-CBD), Cartagena and Nagoya Protocol are legal documents to ensure conservation, sustainable use and sharing of the benefit from the utilization of biodiversity and its components. There is a high demand for the developed nations on access to biodiversity to uncover its benefit. The mechanism on access, fair and equitable sharing of the benefit from the utilization of biodiversity and its component are certainly full of ethical dilemma. For this, there is a great need for the developing country having rich biodiversity find the most appropriate way to manage biodiversity and traditional knowledge for their prosperity. Trust between countries rich in biodiversity and countries having high science and technology capacity is a crucial factor. Greater transparency and the recognition on comprehensive rights of people providing biodiversity is a key element in maintaining trust. Ethical standards cannot depend solely on rules or guidelines. (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)

In lieu of an abstract, here is a brief excerpt of the content:Re-examining Empirical Data on Conflicts of Interest Through the Lens of Personal NarrativesEmily E. Anderson and Elena M. KrausIntroductionThe personal stories submitted by physicians and researchers for this symposium add much–needed dimension to conversations on conflicts of interest in medicine and research. Narratives from individuals living with conflicts of interest can serve as a unique lens through which to consider psychological and economic theories and survey data on physician (...) and patient views. In our reading of these personal narratives, we identified four primary themes that will serve as springboards for our commentary. We aim to triangulate clusters of meaning drawn from the narratives with relevant data from published empirical studies and identify gaps in knowledge where more research is needed. These themes are: the unique environments of medicine and research; weighing the potential benefits of conflicts of interest against the risks; conflict of interest management; and the roles and responsibilities of diverse stakeholder groups.The Unique Challenges of the Medical and Research EnvironmentsThe reflections of the narrative authors draw attention to many of the unique environmental aspects of medicine and medical research that make physicians and researchers especially vulnerable to conflicts of interest. Conflicts of interest may be more ubiquitous in medicine than in any other industry (Kassirer, 2006). As the narratives demonstrate, conflicts of interest emerge across a range of health care delivery and research activities. Surveys have shown that 94 percent of physicians have some kind of relationship with industry (Campbell, Gruen, Mountford, et al., 2007). There is also evidence that physician interactions with medical industry begin early and are a regular part of a physician’s professional practice along the career continuum (Wazana, 2000).Medicine as a profession is distinct from banking or law. It is often said that medicine is an art; in treating patients, creative individualized solutions and gut instinct are as (if not more) important than the application of scientific knowledge. Uncertainty surrounds medical decision making. There is limited precision with respect to diagnoses and prognoses, limited data regarding the effectiveness of many treatments, and a range of patient values and preferences. Because of this uncertainty, rules about practice standards, especially with respect to avoidance and management of conflicts of interest, cannot be as explicit as they are in law or business. As demonstrated by the story presented by Sal Cruz–Flores, research and practice often intersect. And, there is no system in greater need of reform—and no system about which there are more divergent opinions as to what shape that reform should take—than the United States health care [End Page 91] system. The narratives of Tony Mikulec, Govind Nagaldinne, and David M. Zientek demonstrate how various aspects of the structure of healthcare service provision and third–party payer arrangements have the potential to harm patients. Conflicts of interest comprise more than relationships with pharmaceutical and medical device manufacturers.The narratives of Laura Jean Bierut and David M. Zientek also discuss examples of conflicts of interest that arise from factors beyond relationships with industry or the direct potential for financial gain. This may be somewhat unique to the medical milieu. Non-financial conflicts such as a desire for the prestige bestowed upon scientists who make key discoveries, a requirement to publish for tenure and promotion, the need to maintain one’s license or other privileges, or simply the pressure of a competitive environment can influence physician and researcher behavior. As noted by Bierut, more research on how to identify and manage non-financial conflicts is needed.The Potential Benefits and Harms of Conflicts of InterestConflicts of interest are usually presented in a negative light, particularly those that involve physician relationships with the pharmaceutical industry. To “have a conflict of interest” is to be in a situation or role where there is potential for personal interests to be prioritized over professional responsibilities. However, in terms of public perception, it seems that conflicts of interest have become almost synonymous with wrongdoing. Perhaps this is due to the barrage of media reports during the last decade on significant harms caused by financial conflicts of interest in business, journalism, and sports as well as in medicine (Steinbrook, 2004). Amidst... (shrink)

The pharmaceutical industry has been criticised for pervasive misconduct. These concerns have generally resulted in increasing regulation. While such regulation is no doubt necessary, it tends to assume that everyone working for pharmaceutical companies is equally motivated by commerce, without much understanding of the specific views and experiences of those who work in different parts of the industry. In order to gain a more nuanced picture of the work that goes on in the “medical affairs” departments of (...) class='Hi'>pharmaceutical companies, we conducted 15 semi-structured interviews with professionals working in medical departments of companies in Sydney, Australia. We show that this group of pharmaceutical professionals are committed to their responsibilities both to patients, research participants, and the public and to their companies. Despite the discrepancies between these commitments, our participants did not express much cognitive dissonance, and this appeared to stem from their use of two dialectically related strategies, one of which embraces commerce and the other of which resists the commercial imperative. We interpret these findings through the lens of institutional theory and consider their implications for pharmaceutical ethics and governance. (shrink)

No healthcare system has sufficient funds to provide the best possible treatment for all patients in all situations. Three new pharmaceutical products are licensed each month, on average, in the U.K. Most have some benefits over existing drugs but many are expensive. When is the extra benefit worth the extra cost? Managed care systems such as seen in the U.S., and publicly funded systems such as the British National Health Service (NHS), face this fundamental issue. Several governments (for (...) example those in New Zealand, Sweden, and the Netherlands) have taken a lead both in acknowledging that rationing healthcare is necessary, and in outlining how priorities are to be determined. In addition, the state of Oregon addressed the issue of rationing with considerable public involvement. (shrink)

Objective: To determine the views of people with multiple sclerosis (MS) and professionals in relation to confidentiality, consent and access to data within a proposed MS register in the UK. Design: Qualitative study using focus groups (10) and interviews (13). Setting: England and Northern Ireland. Participants: 68 people with MS, neurologists, MS nurses, health services management professionals, researchers, representatives from pharmaceutical companies and social care professionals. Results: People with MS expressed open and altruistic views towards the use of their (...) personal information to facilitate service provision and research, placing trust in responsible guardianship and legitimate use of their information. Participant’s proposed that people with MS should be able to select their individual level of involvement in a register using levels of consent. It was agreed that access to the register should be governed by a guardianship committee composed of a range of stakeholders. People with MS did not wish their details to be used by marketing agencies and did not consider this a legitimate use of their data. Whilst participants were positive of the role a register could play in promoting research, participants felt that access to data by pharmaceutical industries should be administered by the guardianship committee. People with MS are concerned should their employers be able to access their personal information. Professionals were more cautious than people with MS in their approach to the use of patient personal data within a register. Conclusions: Whilst all stakeholders were positive of the benefits of an MS register, development of such a resource must incorporate robust data security and guardianship measures in order to ensure that, whilst opportunities are maximised, risks to the privacy of individuals and legal challenges to professionals are avoided. (shrink)

The United States Food and Drug Administration , in collaboration with pharmaceutical manufacturers, have recently implemented a heavily revised risk-management program for patients on isotretinoin , a drug with known and pronounced teratogenic effects. This revised risk management plan places significant burdens on both providers and patients in the hopes of achieving its goal of reducing fetal exposure to isotretinoin. The main focus of this paper is to discuss the burdens of various aspects of the program in relationship to (...) potential corresponding benefits. In particular, we evaluate the pregnancy rates of women on isotretinoin therapy compared with that of the general population and the rate changes based on the risk management programs. Additionally, we investigate whether the benefits of the program for women have increased as the benefits have risen. We devote special attention to the ethical implications of the intent of the program and to an analysis of the ethical justification of the restrictions placed on women of childbearing potential as it compares to the risk-benefit relationship of using isotretinoin. (shrink)

Pharmaceutical companies routinely engage physicians, particularly those with prestigious academic credentials, to deliver educational talks to groups of physicians in the community to help market the company's brand-name drugs. These speakers receive substantial compensation to lecture at events sponsored by pharmaceutical companies, a practice that has garnered attention, controversy, and scrutiny in recent years from legislators, professional associations, researchers, and ethicists on the issue of whether it is appropriate for academic physicians to serve in a promotional role. These (...) relationships have become so contentious that three years ago the pharmaceutical industry trade association, the Pharmaceutical Research and Manufacturers of America, adopted voluntary guidelines stating that drug companies should stop giving doctors free pens, calendars, sports bags, or tickets to entertainment events. Further, numerous medical associations, such as the Association of American Medical Colleges, the American Board of Internal Medicine and the Institute on Medicine as a Profession, and government bodies such as the Institute of Medicine have recommended that medical schools and teaching hospitals prohibit or strongly discourage faculty from participating in so-called industry Speakers Bureaus — promotional events designed solely to market pharmaceutical products. (shrink)

The aim of this research is to investigate the mediating role of relationship quality in the relationship between relational benefits and customer citizenship behavior. Data were gathered through a systematic sampling from 334 passengers. A Survey technique was used to collect the data from respondents from multiple airports. Data were analyzed through partial least square structural equation modeling using SmartPLS 3.3. The results of the study reveal that altruistic benefits, confidence, and self-expression benefits have a positive relationship (...) with relationship quality while socialization benefits have a non-significant relationship with relationship quality. Similarly, relationship quality mediates the relationship between altruistic benefits, confidence and self-expression benefits, and customer citizenship behavior while relationship quality does not mediate the relationship between socialization benefits and customer citizenship behavior. This study uncovers the relational benefits and its role in the generation of customer citizenship behavior in the aviation sector and the role of relationship quality that could help managers to cultivate the benefits of customer citizenship behaviors. (shrink)

Promoting Farmer Managed Natural Regeneration (FMNR) aims to increase the productive capacities of farmer households. Under FMNR, farmers select and manage natural regeneration on farmlands and keep them under production. While FMNR contributes to the wealth of farming communities, its contribution to household food security has rarely been researched. We, therefore, used a mixed-methods approach to address the research gap by measuring FMNR’s contribution to food security among farmer households in the Talensi district of Ghana. We adopted the Household Dietary (...) Diversity Score (HDDS) and Food Consumption Score (FCS) to estimate food security status among 243 FMNR farmer households and 243 non-FMNR farmer households. Also, we performed a Chi-square test of independence to compare the frequency of each food group (present vs not present) between FMNR adopters and non-FMNR adopters to establish the relationship between adopting FMNR and consuming the FCS and HDDS food groups. Our results reveal that FMNR farmer households are more food secure than non-FMNR farmer households. The HHDS of the FMNR farmer households was 9.6, which is higher than the target value of 9.1. Conversely, the HHDS of the non-FMNR farmer households was 4.3, which is lower than the target value of 9.1. Up to 86% and 37% of the FMNR farmer households and non-FMNR farmer households fell within acceptable FCS; 15% and 17% of FMNR farmer households and non-FMNR farmer households fell within borderline FCS. While none of the FMNR farmer households fell within poor FCS, 46% of non-FMNR farmer households fell within poor FCS. Adopting FMNR is significantly related to consuming all food groups promoted and benefiting from FMNR practices. The paper recommends enabling farmers in semi-arid environments to practice and invest in FMNR for long-term returns to food security. (shrink)

Presently, the pharmaceutical industry funds about half of the costs of continuing medical education programs in the U.S. This contributes to the ethical problems that pervade the relationship between medicine and the pharmaceutical industry: trustworthiness and conflicts of interest. The problems are exacerbated by rationalizations prevalent on both sides that deny the ethical concerns. Commercialism and commercial bias are highly visible at large CME gatherings, and available data, while scanty, back up the view that physician attendees' subsequent prescribing (...) practices are influenced by the commercial message. The industry believes that it will recoup $3.56 in increased sales for every dollar that it invests in CME. New guidelines instituted by the Accreditation Council for Continuing Medical Education in 2004 may succeed in reducing excessive commercial influence, especially since the Department of Health and Human Services has also warned the industry of possible anti-kickback violations if firewalls are not erected between CME funding and marketing of drugs. Critics counter that early indicators of improvement are lacking. (shrink)

This article offers a hybrid rhetorical-qualitative discourse analysis of the FDA’s 2011 Avastin Hearing, which considered the revocation of the breast cancer indication for the popular cancer drug Avastin. We explore the multiplicity of stakeholders, the questions that motivated deliberations, and the kinds of evidence presented during the hearing. Pairing our findings with contemporary scholarship in rhetorical stasis theory, Mol’s (2002) construct of multiple ontologies, and Callon, Lascoumes, and Barthe’s (2011) “hybrid forums,” we demonstrate that the FDA’s deliberative procedures elides (...) various sources of evidence and the potential multiplicity of definitions for “clinical benefit.” Our findings suggest that while the FDA invited multiple stakeholders to offer testimony, there are ways that the FDA might have more meaningfully incorporated public voices in the deliberative process. We conclude with suggestions for how a true hybrid forum might be deployed. (shrink)

Does being green facilitate product innovation? This study examines whether green management in firms operating in China fosters radical product innovation to a greater extent than it does incremental product innovation and investigates the underlying institutional mechanisms involved in the relationship between green management and product innovation. The findings show that green management is more likely to lead to radical product innovation than to incremental product innovation. Moreover, government support as a formal institutional benefit more strongly mediates the effect of (...) green management on radical product innovation than its effect on incremental product innovation; whereas social legitimacy as an informal institutional benefit more strongly mediates the effect of green management on incremental product innovation than its effect on radical product innovation. These findings provide important implications for explaining how firms employ green management to facilitate product innovation. (shrink)

According to the broaden-and-build theory of positive emotions, the frequency of positive emotions is associated with the development of positive attitudes, cognitions, and behaviors in organizational contexts. However, positive and negative attitudes at work might also be influenced by different personal and job resources. While emotional intelligence has been significantly associated with positive job attitudes and personal well-being, no studies have yet examined the joint role of teacher happiness and emotional intelligence in key teacher job attitudes. The present study assesses (...) whether emotional intelligence interacts with levels of teacher happiness to jointly explain important teacher job attitudes. A total sample of 685 teaching professionals filled out a battery of scales including subjective happiness, emotional intelligence, job satisfaction, and turnover intention. Our results revealed that subjective happiness was significantly associated with both higher job satisfaction and lower turnover intention. Likewise, emotional intelligence was positively related to happiness and job satisfaction, and negatively related to turnover intention. Finally, interaction analysis showed the main effects of happiness and emotional intelligence in explaining teacher job attitudes. Beyond the main effects, the interaction effects of happiness and emotional intelligence were significant in predicting all teachers' job attitude indicators, even controlling for the effects of their sociodemographic variables. This work expands our knowledge about the role of teachers' positive emotions in the development of positive work attitudes, and also supports the inclusion of emotional skills in future teacher preparation programs as resources to facilitate work-related well-being. (shrink)

This article analyses whether benefits arising for human resource management from environmental management activities drive environmental management system implementation. Focusing on employee satisfaction and recruitment/retention, it tests this for German manufacturing firms in 2001 and 2006 and incorporates a rare longitudinal element into the analysis. It confirms positive associations of the benefit levels for both variables with environmental management system implementation on a large scale. Also it provides evidence that increasing levels of environmental management system implementation result from higher (...) economic benefits in the human resource domain. In doing so the article supplies needed quantitative evidence on important aspects of how sustainability relates to human resource management. (shrink)

Drawing on ethical principles of fairness and integrative social contracts theory, moral obligations of fair dealing exist between the firm and all shareholders. This study investigates empirically whether privileged investors of publicly traded firms engage in legal, but morally questionable, trading that at the expense of non-privileged institutional or atomistic investors. In this context, we define privilege as the access to material, nonpublic earnings surprise information. Our results show that the opportunity for procedural unfairness increases with the presence of privileged (...) investors. However, this procedural unfairness does not appear to lead to distributive unfairness even though the level of abnormal trading also increases with the presence of privileged investors. That is, our findings suggest that other shareholders are in fact better off from an outcome perspective given that the abnormal stock price returns upon the announcement of an earnings surprise are either more positive or less negative when the firm has a high proportion of privileged investors. We extract the important implications of our study for future research on the fairness of capital markets and information asymmetry amongst classes of investors, as well as for public policy. (shrink)

Human consumption of pharmaceuticals often leads to environmental release of residues via urine and faeces, creating environmental and public health risks. Policy responses must consider the normative question how responsibilities for managing such risks, and costs and burdens associated with that management, should be distributed between actors. Recently, the Polluter Pays Principle (PPP) has been advanced as rationale for such distribution. While recognizing some advantages of PPP, we highlight important ethical and practical limitations with applying it in this context: PPP (...) gives ambiguous and arbitrary guidance due to difficulties in identifying the salient polluter. Moreover, when PPP does identify responsible actors, these may be unable to avoid or mitigate their contribution to the pollution, only able to avoid/mitigate it at excessive cost to themselves or others, or excusably ignorant of contributing. These limitations motivate a hybrid framework where PPP, which emphasizes holding those causing large-scale problems accountable, is balanced by the Ability to Pay Principle (APP), which emphasizes efficiently managing such problems. In this framework, improving wastewater treatment and distributing associated financial costs across water consumers or taxpayers stand out as promising responses to pharmaceutical pollution from human use. However, sound policy depends on empirical considerations requiring further study. (shrink)

The Problem Economic efficiency is naturally thought to be a virtue of social policies and decisions, and cost-benefit analysis is commonly regarded as a technique for measuring economic efficiency. It is not surprising, then, that CB analysis is so widely used in social policy analysis. However, there is a great deal of controversy about CB analysis, including controversy about its underlying philosophical rationale. The rationales that have been proposed fall into three basic, though not mutually exclusive categories. There are moralist (...) views to the effect that an acceptable CB analysis would provide, or contribute to, an ethical appraisal of proposed policies or projects. There are rationalist views to the effect that an acceptable CB analysis would contribute to the selection of social policies and projects that are “socially rational.” Finally, there are so-called management science views to the effect that the purpose of CB analysis is to promote the achievement of objectives held by the policy maker, whatever they may be. Different positions are available within each of these categories. But there is also the possibility that CB analysis lacks any viable rationale. I will examine some of the major rationales for CB analysis in this paper, and I will suggest that the last view is close to the truth. (shrink)

Using private benefits of control and earnings management data from 41 countries and regions, we provide strong evidence that cultures, together with legal rules and law enforcement, play a critical role in shaping corporate behavior. More specifically, we find that private benefits of control are larger and earnings management is more severe in collectivist as opposed to individualist cultures, consistent with the argument that agency problems between corporate insiders and outside investors are severe in collectivist culture. These results (...) are robust to the inclusion of controls for country wealth, economic heterogeneity across countries, and international differences in ownership concentration. (shrink)

Pharmacological substances used to improve cognition and brain function range from dietary supplements and caffeine to drugs targeted at altering particular neurochemical concentrations in the brain. This article considers current scientific research into pharmaceutical cognitive enhancement and likely future directions. Then it discusses the trends in the use of PCEs within patients groups for whom they were intended, as well as in those for whom they were not originally intended, including healthy adults and children. Finally, it provides an overview (...) of current and future ethical considerations and concludes that the use of PCE will likely continue both within patient and healthy individuals in the foreseeable future. Information regarding actual use, benefits, and harms in various populations is severely lacking. Therefore, more emphasis should be placed on obtaining the relevant empirical data, for example, by the long-term monitoring of effectiveness and side effects, and by accurate large-scale surveys to assess actual usage. (shrink)

The point, for the 946,326th time is that people get elected to office by currying the favor of powerful interest groups. They don’t get elected for their excellence as political philosophers.Congress has consistently failed to solve some serious problems with the cost, effectiveness, and safety of pharmaceuticals. In part, this failure results from the pharmaceutical industry convincing legislators to define policy problems in ways that protect industry profits. By targeting campaign contributions to influential legislators and by providing them with (...) selective information, the industry manages to displace the public’s voice in developing pharmaceutical policy. (shrink)

Background: Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey. Methods: Data on the descriptive characteristics of bioethics consultations were (...) collected from 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007. Results: Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive. Conclusions: Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service raises awareness about bioethics, empowers employees to raise bioethical concerns, and helps them reason through challenging issues. (shrink)

The ProblemEconomic efficiency is naturally thought to be a virtue of social policies and decisions, and cost-benefit (CB) analysis is commonly regarded as a technique for measuring economic efficiency. It is not surprising, then, that CB analysis is so widely used in social policy analysis. However, there is a great deal of controversy about CB analysis, including controversy about its underlying philosophical rationale. The rationales that have been proposed fall into three basic, though not mutually exclusive categories. There aremoralistviews to (...) the effect that an acceptable CB analysis would provide, or contribute to, anethicalappraisal of proposed policies or projects. There arerationalistviews to the effect that an acceptable CB analysis would contribute to the selection of social policies and projects that are “socially rational.” Finally, there are so-calledmanagement scienceviews to the effect that the purpose of CB analysis is to promote the achievement of objectives held by the policy maker, whatever they may be. Different positions are available within each of these categories. But there is also the possibility that CB analysis lacksanyviable rationale. I will examine some of the major rationales for CB analysis in this paper, and I will suggest that the last view is close to the truth. (shrink)

Diabetes self-management is a crucial part in the management of diabetic patients. Most randomized controlled clinical trials reported significant benefits by diabetes self-management education on DSM behaviors and metabolic control. Although the randomized clinical trials are the gold standard method in assessing the effectiveness of any intervention, including DSME interventions, the outcomes of these studies may reflect exaggerated effects; because in most of these studies, subjects in control group receive usual care with no any DSME. The lack of such (...) education in the control group had many drawbacks: make blindness impossible; at which non blinded studies may result in false-positive findings; it may be unethical to recruit patients for participation in DSME studies as control subjects, most of these studies with long periods of follow up, without any direct benefit to them during the study period; the lack of direct benefit to control subjects in any clinical trial may results in high attrition rate. The high attrition rate in clinical trials especially in the control group can lower the statistical power of the study results; thus, the DSME program would appear to have positive effects even if the program had no real benefit. This problem of the DSME exaggerated effects can be solved partially through providing control subjects with education about some DSM behaviors or comparing the effect of DSME through different educational approaches. (shrink)

In 2003, the pharmaceutical company Biovail received a spate of negative publicity around a program for its heart medication Cardizem LA. For a three-month period Biovail paid US doctors US$1000 (and their office managers US$150) for patient data when at least 11 of their patients renewed a prescription to Cardizem. Doctors who signed up for the trial but who did not keep 11 patients on the drug received US$250 for participation. According to Biovail, this was a research trial, meeting (...) US federal regulations for research trials – the consulting firm that had designed the trial had guaranteed that it would meet US criteria. The trial was expected to provide data that would help ‘in designing future clinical trial programs’, according to Biovail’s vice-president of finance. In addition, the results would eventually be published. However, the program was originally presented as a marketing campaign, and was being handled by Biovail’s sales department and sales force. According to ethicists who commented on the case, a US$1000 payment to doctors was unusually high for a post-marketing research trial, and a US$150 payment to office managers was thought to raise novel ethical conflicts. Cardizem is a drug intended for long-term use, so paying doctors to get patients started on a course of treatment could lead to substantial profits from these prescriptions. In line with this, immediate comments from professional ethicists and representatives of medical associations focused on questions about whether the Biovail campaign amounted to paying doctors to prescribe specific drugs. And that is a concern for the obvious reason that it has the potential to compromise doctors’ decisions about best care. Payments for prescriptions place doctors in ethically difficult situations: Peter Singer, a medical ethicist, says ‘There is clearly the potential for [physicians’] conflict of interest’ (Toronto Globe and Mail, 2003). Physicians’ decision-making is the most common locus of discussion in medical ethics.. (shrink)