The problem of collecting, analyzing and evaluating evidence on adverse drug reactions (ADRs) is an example of the more general class of epistemological problems related to scientific inference and prediction, as well as a central problem of the health-care practice. Philosophical discussions have critically analysed the methodological pitfalls and epistemological implications of evidence assessment in medicine, however they have mainly focused on evidence of treatment efficacy. Most of this work is devoted to statistical methods of causal inference with a special (...) attention to the privileged role assigned to randomized controlled trials in Evidence Based Medicine. Regardless of whether the RCT’s privilege holds for efficacy assessment, it is nevertheless important to make a distinction between causal inference of intended and unintended effects, in that the unknowns at stake are heterogonous in the two contexts. This point has been emphasized by epidemiologists in the last decade. Their main focus is methodological, and regards the fact that bias and confounding do not affect studies on intended and unintended effects in the same way. However, deeper concerns ground the intuition for such a distinction; these are related to the constraints which we impose on evidence and their epistemological justification. My thesis is that such constraints ought to be understood to be different in the case of evidence for risk vs. benefit assessment. I present the recent debate on the causal association between acetaminophen and asthma in order to illustrate the point at issue. (shrink)

In her Pharmaceutical Freedom, Jessica Flanigan argues that antibiotics can be regulated consistent with her otherwise largely deregulatory view with respect to pharmaceuticals and recreational drugs. I contend in this essay that the reasons for justifying antibiotic regulation are reasons that can be offered to justify the regulation of many other drugs, both pharmaceutical and recreational. After laying out the specifics of Flanigan’s view, I suggest that it is amenable to the regulation of drugs like varenicline. Though such (...) drugs can legitimately improve the quality of a patient’s life by helping them quit smoking, they could be permissibly regulated if they expose others to impermissible risks. I then argue that recreational drugs like alcohol could be regulated using the same reasoning. In the penultimate section of this essay, I anticipate objections that one might have to my extension of arguments favoring antibiotic regulation to drugs correlated with aggression. Flanigan might find my extrapolation of her view as entirely plausible and accept that her view is relatively friendly to these regulations, or she might reconsider her antibiotic caveat if these regulations are overly paternalistic on her understanding. I conclude by briefly considering the benefits and drawbacks of adopting each view. (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)

The problem of collecting, analyzing and evaluating evidence on adverse drug reactions (ADRs) is an example of the more general class of epistemological problems related to scientific inference and prediction, as well as a central problem of the health-care practice. Philosophical discussions have critically analysed the methodological pitfalls and epistemological implications of evidence assessment in medicine, however they have mainly focused on evidence of treatment efficacy. Most of this work is devoted to statistical methods of causal inference with a special (...) attention to the privileged role assigned to randomized controlled trials in Evidence Based Medicine. Regardless of whether the RCT’s privilege holds for efficacy assessment, it is nevertheless important to make a distinction between causal inference of intended and unintended effects, in that the unknowns at stake are heterogonous in the two contexts. This point has been emphasized by epidemiologists in the last decade. Their main focus is methodological, and regards the fact that bias and confounding do not affect studies on intended and unintended effects in the same way. However, deeper concerns ground the intuition for such a distinction; these are related to the constraints which we impose on evidence and their epistemological justification. My thesis is that such constraints ought to be understood to be different in the case of evidence for risk vs. benefit assessment. I present the recent debate on the causal association between acetaminophen and asthma in order to illustrate the point at issue. (shrink)

The goal of research in social epidemiology is not simply conceptual clarification or theoretical understanding, but more importantly it is to contribute to, and enhance the health of populations (and so, too, the people who constitute those populations). Undoubtedly, understanding how various individual risk factors such as smoking and obesity affect the health of people does contribute to this goal. However, what is distinctive of much on-going work in social epidemiology is the view that analyses making use of (...) individual-level variables is not enough. In the spirit of Durkheim and Weber, S. Leonard Syme makes this point by writing that just “as bad water and food may be harmful to our health, unhealthful forces in our society may be detrimental to our capacity to make choices and to form opinions” conducive to health and well-being. Advocates of upstream (distal) causes of adverse health outcomes propose to identify the most important of these “unhealthful forces” as the fundamental causes of adverse health outcomes. However, without a clear, theoretically precise and well-grounded understanding of the characteristics of fundamental causes, there is little hope in applying the statistical tools of the health sciences to hypotheses about fundamental causes, their outcomes, and policies intended to enhance the health of populations. This paper begins the process of characterizing the social epidemiological concept of fundamental cause in a theoretically respectable and robust way. (shrink)

Many pharmaceuticals are available to patients only with a physician’s prescription. Although it is often not recognized as such, this is a classic example of paternalism in public policy. Pharmaceuticals are often perceived as carrying dangerous side effects. Access is restricted to protect patients from their own bad decisions. This chapter explores the moral justification for such paternalism and finds it wanting. It raises the question of whether there is adequate justification for this restriction. Consistency requires that pharmaceuticals posing dangers (...) primarily to the individual be available to competent consumers and that even moderate risks to third parties be tolerated. The chapter begins by arguing that all drug usage involves evaluative judgments about the relative benefits and harms of the agents and that physicians must make value judgments in deciding whether to prescribe. (shrink)

Recent debates over the use of sham surgery as a control for studies of fetal tissue transplantation for Parkinson’s disease have focused primarily on rival interpretations of the US federal regulations governing human-subjects research. Using the core ethical and methodological considerations that underwrite the equipoise requirement, we nd strong prima facie reasons against using sham surgery as a control in studies of cellular-based therapies for Parkinson’s disease and more broadly in clinical research. Additionally, we believe that these reasons can be (...) generalized to apply to the use of other placebo controls that carry signi cant risks of positive harms in and of themselves. As a result, our arguments are centrally relevant to the emerging drive to subject therapies with a surgical component to the same rigorous standards of evaluation as those governing the approval of new pharmaceuticals. (shrink)

This book examines how legal causation inference and epidemiological causal inference can be harmonized within the realm of jurisprudence, exploring why legal causation and epidemiological causation differ from each other and defining related problems. The book also discusses how legal justice can be realized and how victims’ rights can be protected. It looks at epidemiological evidence pertaining to causal relationships in cases such as smoking and the development of lung cancer, and enables readers to correctly interpret and rationally use the (...) results of epidemiological studies in lawsuits. The book argues that in today’s risk society, it is no longer possible to thwart the competence of evidence using epidemiological research results. In particular, it points out that the number of cases that struggle to prove a causal relationship excluding those using epidemiological data will lead to an increase in the number of lawsuits for damages that arise as a result of harmful materials that affect our health. The book argues that the responsibility to compensate for damages that have actually occurred must be imputed to a particular party and that this can be achieved by understanding causal inferences between jurisprudence and epidemiology. This book serves as a foundation for students, academics and researchers who have an interest in epidemiology and the law, and those who are keen to discover how jurisprudence can bring these two areas together. (shrink)

In public health research, tracking folk racial categories (in disease risk, etc.) is a double-edged tool. On the one hand, tracking folk racial categories is dangerous because it reinforces a problematic but fairly common belief in biological race essentialism. On the other hand, ignoring racial categories also runs the risk of ignoring very real biological phenomena in which marginalized communities, likely in virtue of their marginalization, are sicker and in need of improved resources. Much of the conversation among epidemiologists and (...) philosophers of medicine concerning the issue of tracking folk racial categories in public health research springs forth from largely black/white binarized health inequities. While health inequities between black and white Americans are certainly a very important topic, I am interested in investigating the complications to this conversation about the potential harms of tracking folk racial categories in public health research generated by the consideration of Indigenous identities in the US—groups whose health inequities are typically tracked based on the folk racial category of “Native American” or “American Indian,” but whose unique identity categories and community membership problematize the current spectrum of approaches to tracking folk racial categories in epidemiologic research. This paper will draw on scholarship by and about Indigenous people in the US context to address an undertheorized facet of the conversations concerning the potential harms of tracking folk racial categories in public health research, including the potential undermining of American Indian sovereignty and Indigenous epistemologies. I will end on some methodological considerations inspired by the inclusion of Indigenous identities in the US in the conversation about tracking folk racial categories in epidemiologic research. (shrink)

Humans have been using fire for hundreds of millennia, creating an ancestral expansion toward the nocturnal niche. The new adaptive challenges faced at night were recurrent enough to amplify existing psychological variation in our species. Night-time is dangerous and mysterious, so it selects for individuals with higher tendencies for paranoia, risk-taking, and sociability. During night-time, individuals are generally tired and show decreased self-control and increased impulsive behaviors. The lower visibility during night-time favors the partial concealment of identity and opens more (...) opportunities for disinhibition of self-interested behaviors. Indeed, individuals with an evening-oriented chronotype are more paranoid, risk-taking, extraverted, impulsive, promiscuous, and have higher antisocial personality traits. However, under some circumstances, such as respiratory pandemics, the psychobehavioral traits favored by the nocturnal niche might be counter-productive, increasing contagion rates of a disease that can evade the behavioral immune system because its disease cues are often nonexistent or mild. The eveningness epidemiological liability hypothesis presented here suggests that during the COVID-19 pandemic, the evening-oriented psychobehavioral profile can have collectively harmful consequences: there is a clash of core tendencies between the nocturnal chronotype and the recent viral transmission-mitigating safety guidelines and rules. The pandemic safety protocols disrupt much normal social activity, particularly at night when making new social contacts is desired. The SARS-CoV-2 virus is contagious even in presymptomatic and asymptomatic individuals, which enables it to mostly evade our evolved contagious disease avoidance mechanisms. A growing body of research has indirectly shown that individual traits interfering with social distancing and anti-contagion measures are related to those of the nocturnal chronotype. Indeed, some of the social contexts that have been identified as superspreading events occur at night, such as in restaurants, bars, and nightclubs. Furthermore, nocturnal environmental conditions favor the survival of the SARS-CoV-2 virus much longer than daytime conditions. We compare the eveningness epidemiological liability hypothesis with other factors related to non-compliance with pandemic safety protocols, namely sex, age, and life history. Although there is not yet a direct link between the nocturnal chronotype and non-compliance with pandemic safety protocols, security measures and future empirical research should take this crucial evolutionary mismatch and adaptive metaproblem into account, and focus on how to avoid nocturnal individuals becoming superspreaders, offering secure alternatives for nocturnal social activities. (shrink)

AbstractDuring the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies in 2020 and 2021. The (...) pharmaceutical company Johnson and Johnson, the National Institutes of Health in the United States, and a private-public partnership of industry, university, and government partners in Britain all undertook preparations. The United Kingdom’s consortium began their Human Challenge Programme in March of 2021.Beyond documenting each effort, the essay puts these scientific and ethical debates in dialogue with the social, epidemiological, and institutional conditions of the pandemic as well as the commercial, intellectual, and political systems in which medical research and Covid-19 challenge studies operated. It shows how different institutions understood risk, benefit, and social value depending on their specific contexts. Ultimately the example of Covid-19 challenge studies highlights the constructedness of such assessments and reveals the utility of deconstructing them retrospectively so as to better understand the interplay of medical research and research ethics with larger social systems and historical contexts. (shrink)

Targeting high-risk populations for public health interventions is a classic tool of public health promotion programs. This practice becomes thornier when racial groups are identified as the at-risk populations. I present the particular ethical and epistemic challenges that arise when there are low-risk subpopulations within racial groups that have been identified as high-risk for a particular health concern. I focus on two examples. The black immigrant population does not have the same hypertension risk as US-born African Americans. Similarly, Finnish descendants (...) have a far lower rate of cystic fibrosis than other Caucasians. In both cases the exceptional nature of these subpopulations has been largely ignored by the designers of important public health efforts, including the recent US government dietary recommendations. I argue that amending the publicly-disseminated risk information to acknowledge these exceptions would be desirable for several reasons. First, recognizing low-risk subpopulations would allow more efficient use of limited resources. Communicating this valuable information to the subpopulations would also promote truth-telling. Finally, presenting a more nuanced empirically-supported representation of which groups are at known risk of diseases (not focusing on mere racial categories) would combat harmful biological race essentialist views held by the public. (shrink)

Post-market pharmaceutical surveillance or ‘pharmacovigilance’ relies on the reporting of suspected adverse drug reactions to regulatory databases. Recently, more ‘active’ methods that directly involve patients in identifying and reporting suspected adverse drug reactions have been suggested. This is different than traditional ‘passive’ methods, e.g., using databases without contacting patients directly. Though there are benefits to active pharmacovigilance, it is not without its potential risks. Here I highlight one of those risks – the nocebo effect. Nocebo effects are harms that (...) are thought to arise by conditioning or negative expectation. If a patient engaged in active pharmacovigilance is improperly motivated to seek out and report suspected adverse drug reactions, nocebo harms can occur. Not only is this a bioethical concern about harm, but it is also an epistemic or data-quality problem. Since nocebo effects are not due to the pharmacological properties of the drugs under investigation, nocebo effects reported as suspected adverse drug reactions constitute false positives in these databases. (shrink)

Background: Both the Council for International Organization of Medical Sciences and the Helsinki Declaration emphasize that the potential benefits of research should outweigh potential harms; consequently, some work has been conducted on participants' perception of benefits in therapeutic research. However, there appears to be very little work conducted with participants who have joined non-therapeutic research. This work was done to evaluate participants' perception of benefits in a genetic epidemiological study by examining their perception of the potential benefits of enrollment.Methods: In-depth (...) interviews lasting between 45 and 60 minutes were conducted with a convenient sample of 25 ill patients and 25 healthy accompanying relatives enrolled in a genetic epidemiological study of tuberculosis. Recorded interviews were transcribed and analyzed using content analysis.Results: Participants perceived that research was beneficial and some of the benefits included the generation of new knowledge, finding the cause of diseases, as well as the control, eradication and prevention of disease. Some thought that research was risky whilst others thought that the benefits outweighed the risks.Conclusion: Participants perceived research to be beneficial and most of them thought that, though it was risky, the benefits outweighed the risks. It is our view that researchers need to give serious consideration to participant's perception of benefits in designing their consent forms, to see to the fulfillment of achievable goals. (shrink)

Like all interventions in health care, direct-to-consumer advertising should be evaluated by comparing its risks to its benefits, in the context of the available or potentially available alternatives. The objective, of course, is to realize any unique benefits while minimizing the risks. On balance, the adverse effects of DTC advertising outweigh the still-undemonstrated benefits of the advertising.DTC advertising must be seen in the context of overall pharmaceutical company expenditures on advertising. In 2005, the industry spent $29.9 billion dollars on (...) promotions, of which a relatively small fraction, $4.2 billion, was spent on DTC advertising. The percentage spent on DTC advertising has been relatively constant this decade. Promotions to professionals and samples accounted for far larger percentages of total promotional spending in 2005. (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)

Human infection challenge studies (HCS) have been proposed as a means to accelerate SARS-CoV2 vaccine development and thereby help to mitigate a prolonged global public health crisis. A key criterion for the ethical acceptability of SARS-CoV2 HCS is that potential benefits outweigh risks. Although the assessment of risks and benefits is meant to be a standard part of research ethics review, systematic comparisons are particularly important in the context of SARS-CoV2 HCS in light of the significant potential benefits and harms (...) at stake as well as the need to preserve public trust in research and vaccines. In this paper we explore several considerations that should inform systematic assessment of SARS-CoV-2 HCS. First, we detail key potential benefits of SARS-CoV-2 HCS including, but not limited to, those related to the acceleration of vaccine development. Second, we identify where modelling is needed to inform risk-benefit (and thus ethical) assessments. Modelling will be particularly useful in (i) comparing potential benefits and risks of HCS with those of vaccine field trials under different epidemiological conditions and (ii) estimating marginal risks to HCS participants in light of the background probabilities of infection in their local community. We highlight interactions between public health policy and research priorities, including situations in which research ethics assessments may need to strike a balance between competing considerations. (shrink)

Postpartum depression is a major maternal health problem after childbirth. It can start at any time within the first year after delivery and continue for several years. It is characterized by an inability to experience pleasure, anxiety symptoms, panic attacks, spontaneous crying and depressed mood. Some women with postpartum depression even have thoughts of harming their child and self-harm. This study aims to find out the status of postpartum depression and the associated factors among postnatal mothers at the first, fourth (...) and sixth month. This study is a prospective descriptive study, carried out in three major health facilities in Misurata. This study consists of a three-part questionnaire. Part 1 covers the demographic characteristics of the participants, while Part 2 explores the associated risk factors according to the variables used. Part 3 consists of the psychological evaluation of the participants. A hundred mothers (ages between 15 and 43 years) were enrolled in this study. The findings revealed that the prevalence of depression is 60.0% and 22.0% are suffering from borderline depression. Development of depression was strongly correlated with sleeping disturbances, the state of the neonate after birth, excess consumption of stimulants, less weight acceptance by mothers during pregnancy and infant illness. There was a weak relation between depression and delivery state, maternal admission to the hospital during the current pregnancy, and infant gender dissatisfaction. No correlation was found with the development of depression regarding miscarriage, maternal medical problems after delivery, previous child sex, maternal age, education, parity or neonate weight. Thus, this study shows that the chance of having a miscarriage and an unhealthy neonate increases with advanced maternal age. It also shows that caesarean section is associated with bad neonatal outcomes, more weight gain and having gestational diabetes or preeclampsia during pregnancy. Maternal sleeping problems are more pronounced in the first month, attributed to the baby's care, compared with the fourth and sixth months. The study indicates that depression is a common state of psychiatric disorders among Libyan women and should have appropriate attention by physicians and gynecologists. (shrink)

Postpartum depression is a major maternal health problem after childbirth. It can start at any time within the first year after delivery and continue for several years. It is characterized by an inability to experience pleasure, anxiety symptoms, panic attacks, spontaneous crying and depressed mood. Some women with postpartum depression even have thoughts of harming their child and self-harm. This study aims to find out the status of postpartum depression and the associated factors among postnatal mothers at the first, fourth (...) and sixth month. This study is a prospective descriptive study, carried out in three major health facilities in Misurata. This study consists of a three-part questionnaire. Part 1 covers the demographic characteristics of the participants, while Part 2 explores the associated risk factors according to the variables used. Part 3 consists of the psychological evaluation of the participants. A hundred mothers (ages between 15 and 43 years) were enrolled in this study. The findings revealed that the prevalence of depression is 60.0% and 22.0% are suffering from borderline depression. Development of depression was strongly correlated with sleeping disturbances, the state of the neonate after birth, excess consumption of stimulants, less weight acceptance by mothers during pregnancy and infant illness. There was a weak relation between depression and delivery state, maternal admission to the hospital during the current pregnancy, and infant gender dissatisfaction. No correlation was found with the development of depression regarding miscarriage, maternal medical problems after delivery, previous child sex, maternal age, education, parity or neonate weight. Thus, this study shows that the chance of having a miscarriage and an unhealthy neonate increases with advanced maternal age. It also shows that caesarean section is associated with bad neonatal outcomes, more weight gain and having gestational diabetes or preeclampsia during pregnancy. Maternal sleeping problems are more pronounced in the first month, attributed to the baby's care, compared with the fourth and sixth months. The study indicates that depression is a common state of psychiatric disorders among Libyan women and should have appropriate attention by physicians and gynecologists. (shrink)

Chemical castration laws, such as one recently adopted in the U.S. State of Louisiana, raise challenging ethical concerns for physicians. Even if such interventions were to prove efficacious, which is far from certain, they would still raise troubling concerns regarding the degree of medical risk that may be imposed upon prisoners in the name of public safety as well as the appropriate role for physicians and other health care professionals in the administration of pharmaceuticals to competent prisoners over the inmates’ (...) unequivocal objections. This paper argues that the concerns raised by chemical castration are grave enough that, until they are adequately addressed by policymakers, physicians ought not to participate in the process. (shrink)

Brent Kious has objected to our previous criticism of his views on doping, maintaining that we, by and large, misrepresented his position. In this response, we strengthen our original misgivings, arguing that (1) his views on risk of harm in sport are either uncontroversially true (not inconsistent with the views of many doping opponents) or demonstrably false (attribute to doping opponents an overly simplistic view), (2) his use of analogies (still) indicates an oversimplification of many issues surrounding the question of (...) doping in sports, and (3) his doping analogies are insufficiently precise to support his conclusions. (shrink)

Over the past decade AIDS research has turned toward the use of pharmacology in HIV prevention, including pre-exposure prophylaxis (PrEP): the use of HIV medication as a means of preventing HIV acquisition in those who do not have it. This paper explores the contradictory reasons offered in support of PrEP—to empower women, to provide another risk-reduction option for gay men—as the context for understanding the social meaning of the experimental trials that appear to show that PrEP works in gay men (...) and heterosexual couples but not single women. The PrEP debates reveal the different ideas about “demedicalization” in the earlier gay health and women’s health movements and highlight the relationship between health activism and critique of research ethics in the context of a global pharmaceutical market. (shrink)

Research drawn from data contained in medical records is a common and immensely important means of scientific investigation in epidemiology and health services research. It provides valuable knowledge regarding risk factors for disease, the safety of pharmaceuticals and medical procedures, and the quality of medical care. Electronic information technology has greatly enhanced the capability of conducting research using medical records, but it has also generated increasing concern about invasions of privacy. Both practical and scientific considerations militate against soliciting consent (...) for population-based observational research. Retrospective review of existing medical records, especially with large samples, poses insuperable barriers to locating human subjects in order to obtain their informed consent. When efforts are made to obtain informed consent for prospective research drawn from disease and treatment registries, mounting evidence has accumulated that substantial selection biases are introduced into the data, as those who consent are not necessarily representative of the population of relevant patients. (shrink)

Short-term humanitarian medical volunteerism has grown significantly among both clinicians and trainees over the past several years. Increasingly, both volunteers and their respective institutions have faced important challenges in regard to medical ethics and professional codes that should not be overlooked. We explore these potential concerns and their risk factors in three categories: ethical responsibilities in patient care, professional responsibility to communities and populations, and institutional responsibilities towards trainees. We discuss factors increasing the risk of harm to patients and communities, (...) including inadequate preparation, the use of advanced technology and the translation of Western medicine, issues with clinical epidemiology and test utility, difficulties with the principles of justice and clinical justice, the lack of population-based medicine, sociopolitical effects of foreign aid, volunteer stress management, and need for sufficient trainee supervision. We review existing resources and offer suggestions for future skill-based training, organisational responsibilities, and ethical preparation. (shrink)

Overtreatment refers to interventions that do not benefit the patient, or where the risk of harm from the intervention is likely to outweigh any benefit the patient will receive. It can account for up to 30% of health care costs, and is increasingly recognised as a widespread problem across nations and within clinical and scientific communities. There are a number of inter-related factors that drive overtreatment including the expanding definition of diseases, advertising and the influence of the pharmaceutical industry, (...) how doctors are trained and remunerated, demands from patients and the fear of complaints leading doctors to practise defensively.This paper discusses a number of ethical and practical issues arising from overtreatment that doctors and patients should be aware of. It also considers the flow-on effects of overtreatment such as the increased cost of care, increase in work load for health professionals, and wastage as resources are diverted from more genuine and pressing needs. In addition, there are references to a number of Medical Council of New Zealand statements about what good medical practice means in an environment of resource limitation. The paper concludes with a few measures that doctors and patients could take to reduce overtreatment but acknowledges that health care is extremely complex so it would be unrealistic to eliminate overtreatment entirely. (shrink)

Physicians and institutional providers face expanding liability exposure today, in spite of state tort reform legislation and public awareness of the costs of malpractice for providers. Standards of practice are evolving rapidly; new medical technologies are being introduced at a rapid rate; information is proliferating as to treatment efficacy, patient risk, and diseases generally. Tort standards mirror this change. As medical standards of care evolve, they provide a benchmark against which to measure provider failure. The liability exposure of physicians is (...) affected by the generation of data, including outcomes data usable to profile physician practice, and statistical data that allows for predictions as to treatment efficacy, and patient prognosis; obligations to inform patients and third parties of risk created by contagious disease and other sources of harm; obligations of physicians to disclose risks that the provider creates for the patient; obligations to disclose conflicts of interest arising out of the practice setting; and duties arising from new epidemiological knowledge. (shrink)

The nascent for-profit psychedelic industry has begun to engage in corporate practices like funding scientific research and research programs. There is substantial evidence that such practices from other industries like tobacco, alcohol, pharmaceuticals and food create conflicts of interest and can negatively influence population health. However, in a context of funding pressures, low publicly funded success rates and precarious academic labor, there is limited ethics guidance for researchers working at the intersection of clinical practice and population health as to how (...) they should approach potential financial sponsorship from for-profit entities, such as the psychedelic industry. This article reports on a reflective exercise among a group of clinician scientists working in psychedelic science, where we applied Adams’ (2016) PERIL (Purpose, Extent, Relevant harm, Identifiers, Link) ethical decision-making framework to a fictionalized case of corporate psychedelic financial sponsorship. Our analysis suggests financial relationships with the corporate psychedelic sector may create varying degrees of risk to a research program’s purpose, autonomy and integrity. We argue that the commercial determinants of health provide a useful framework for understanding the ethics of industry-healthcare entanglements and can provide an important population health ethics lens to examine nascent industries such as psychedelics, and work toward potential solutions. (shrink)

Ingmar Persson and Julian Savulescu argue that non-traditional forms of cognitive enhancement (those involving genetic engineering or pharmaceuticals) present a serious threat to humanity, since the fruits of such enhancement, accelerated scientific progress, will give the morally corrupt minority of humanity new and more effective ways to cause great harm. And yet it is scientific progress, accelerated by non-traditional cognitive enhancement, which could allow us to dramatically morally enhance human beings, thereby eliminating, or at least reducing, the threat from the (...) morally corrupt minority. I argue that this apparently intractable dilemma is less difficult to resolve than Persson and Savulescu suppose. Their analysis of non-traditional cognitive enhancement overstates the risks and undervalues the benefits that such enhancement might provide. Once the benefits are better described, it is clear that non-traditional cognitive enhancement could be the means of our survival, not of our destruction. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that women have been inadequately (...) represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have increasingly become the subject of experiments that offer them no potential direct benefit but expose them to risks of harm and pain. A wide range of such experiments will be examined, including a lethal heartburn drug test, the experimental insertion of a pacemaker, an invasive insulin infusion experiment, and a fenfluramine "violence prediction" experiment. (...) Emphasis, however, is given to psychoactive drug tests because of the inherent ethical and diagnostic problems involved in the absence of any objective, verifiable diagnostic tool. Effort is made to provide readers comprehensive reference sources to evidence-based reports about the serious risks these drugs pose for adults and children so that the reader may judge whether the benefits (if any) outweigh the risks for children. The first ethical issue raised by these experiments is: did the severity of illness in these children justify their exposure to short and long-term risks? The ethics of the experiments will be evaluated by referring to existing codes of medical research ethics-the Nuremberg Code, the Declaration of Helsinki, and the federal Code of Regulations. The thirteen cases presented will demonstrate that children are being used in ever more speculative experiments, often in the absence of a therapeutic intent, but a significant chance for causing harm and / or discomfort. Some of the experiments were designed to explore the mechanisms of pathology and pharmacological interventions, or the response of neurological brain receptors to chemical provocation ("challenge"). Others were designed to test the safety or efficacy of new drugs, even to test these drugs on healthy children who were hypothesized to be "at risk." Children and adolescents have been subjected to "forced dose titration" experiments that induced a spectrum of severe adverse effects, including insomnia, extreme restlessness, agitation, (akathisia) and self-injurious behavior. FDA reports show that suicide is a significant issue in psychotropic drug trials-in pediatric trials the problem is even greater. The paper aims to demonstrate how the enactment of the Better Pharmaceuticals for Children Act (incorporated into the Food and Drug Administration Modernization Act, FDAMA), set in motion a radical shift in public policy by providing huge financial incentives to pharmaceutical companies to test new or patented drugs in children. Federal policy shifted from one aimed at protecting children by setting limits on permissible research risks, to a policy aimed at broadening the inclusion of children as test subjects. It will be shown how the FDA and the Department of Health and Human Services lifted regulatory restrictions to permit research involving greater than minimal risk to be conducted on healthy children, claiming that all children are potentially "at risk" of a future condition. Children were in this way deprived of regulatory protections. An argument will be made that the approval of nontherapeutic, harmful experiments-such as exposure of toddlers to lead poison-under the current gate keeping system raises serious doubts about the sustainability of institutional review boards (IRBs) as protectors of human research subjects. Children, who are precluded from exercising the adult human's right to informed consent, are being exploited as commodities for commercial ends. It is the position of the author that nothing less than the enactment of a federal law mandating a radical overhaul of the current research review system, with independent checks and balances, will provide children the legal protections they need. Ten specific recommendations are offered to protect children from harmful experiments. (shrink)

A 78-year-old Chinese woman joined a clinical trial sponsored by a Pharmaceutical companies. Unfortunately a serious Serious Adverse Event occurred. The sponsor paid for the cost of the medical care arising from the SAE, but refused the family’s request for compensation. The family then sued the company and the hospital in Beijing. Although the SAE was related to a complication of lower extremity angiography and not the drug itself, it was a direct consequence of participating in the trial. According (...) Good Clinical Practice, a set of regulations promulgated under Chinese law, “the sponsor should provide Insurance to those human subjects who participate in clinical trials, cover the cost of Treatment and the corresponding economic compensation for the occurrence of the harm or death associated with the trial”. The court ordered the trial sponsor to provide a translation of the company’s insurance policy, so that the court could understand the amount of compensation available to the Patient under the policy, but the sponsor never surrendered either the documentation or a translation. Consensus was never reached about the amount of compensation due to the patient through negotiation with the hospital, the company and the family. The Litigation ended after nine hearings and five long years. This chapter provides an ethical analysis of the case relative to at least three areas of Risks of Exploitation when a major, international Pharmaceutical companies sponsors clinical research in a country with an immature legal system and where Research participants have limited resources. (shrink)

Violence is a known risk factor for health problems. In this epidemiological study across 5,385 male patients, we investigate the prevalence of perpetrated violence, exposure to violence, their overlap and the relationship between violence, mental, and psychosomatic health, as well as adverse health behaviors, such as self-harming behavior and the consumption of drugs. Participants completed an anonymous questionnaire addressing violence experience, age of victimization/perpetration, frequency, and perceived severity of violence exposure. We considered physical, psychological as well as sexual violence. Information (...) on health status and adverse health behaviors complemented the data. Results showed that 48.4% of the sample reported having experienced violence. The victim-perpetrator overlap formed the largest group, in which the incidence of having experienced multiple types of violence was significantly higher compared to victims and perpetrators. The age-crime curve flattened more slowly with increasing age in this group. Although the perceived severity of exposure to violence is lower in the overlap group, its health status and adverse health behaviors were worse. Interventions should focus on this group since they constitute a burden for the healthcare system. (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)

In light of the recent focus in bioethics on questions of deliberate moral enhancement through the use of psychoactive drugs, Levy et al. (2014) argue that the more pressing issue may be the incidental effect that prescription drugs could already be having on moral agency. Although concerns have focused on the possibility of altering moral psychology through direct effects on brain function, the authors point out that this may already be a reality, albeit an unintentional one. They conclude from their (...) survey of prescription drugs already in use, that we should urgently investigate the ways they may be “influencing the shape of our societies” (2014, 123). The question of how we ought to respond to this possibility, I believe, must be considered in the broader context of existing attitudes and policy in response to substances with similar effects; and the relative significance of these drug effects compared with other factors, in particular social factors that shape society through their developmental influence on moral psychology. -/- First, it is important to consider the drugs described by the authors alongside widely used drugs with known, comparable effects. For example, alcohol has profound effects on features of cognition that seem relevant to moral agency, in altering risk assessment and increasing aggression (Bushman and Cooper 1990; George et al. 2005). Its impairing of inhibitory control arguably undermines the reflective processes that are often considered central to moral agency (Craigie 2011; Field et al. 2010). However, by and large the current policy adopted in liberal democratic societies is to educate people about these dangers but leave it up to adults to choose whether they use alcohol. Exceptions to this position are grounded in reasons of public protection, for example, in the case of blood alcohol limits for drivers in order to protect people against injury or death as a result of drunk driving. Restrictions are also sometimes placed on inebriation in the context of particular public roles, for example, serving on a jury, although the issue remains controversial (Law Reform Commission 2010, s. 8.21, 8.26, 8.27). This approach to alcohol regulation offers an established model for responding to the kinds of drugs in question. Broadly, it suggests that concerns about the effect of a drug on moral agency are only considered serious enough to warrant restricting its use when this puts others at risk of serious harms, or when a person is fulfilling a public role where sound decision making is of great importance (e.g., in maintaining trust in institutions such as the criminal justice system). Although at first it may be an alarming thought that pharmaceuticals [End Page 127] could be influencing individual moral psychology, the example of alcohol suggests that this this is a familiar experience, and something for which states already have a policy framework. -/- Caffeine is another commonly used drug with psychoactive properties that seem likely to affect moral agency. Along with potentially morally relevant effects on attention and aggression (Einöther and Giesbrecht 2013; Kuhns et al. 2010), research suggests a connection between cortisol—a hormone that is elevated by caffeine—and the processing of social cues relating to threat (Montoya et al. 2012; Putman et al. 2007). There are little in the way of restrictions on the use of caffeine. Nonetheless, one might be concerned about the possible effects of caffeine on moral agency and society, particularly if the effects are less obvious than in the case of alcohol (Kuhns et al. 2010). The same concern might apply to the pharmaceuticals in question. Perhaps there is a need to investigate these effects on thought and behavior because they are not easy to detect. The greater danger might be in the fact that people do not recognize how these drugs change their appraisals and decisions, rather than in the effects themselves. It seems a reasonable suggestion that if a drug has significant enough effects on interpersonal relationships, then this information should be made available as a part of an informed consent procedure. (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 prevalence of obesity, metabolic syndrome, and the associated long-term chronic diseases (cardiovascular disease, type II diabetes, cancer, Alzheimer’s disease, depression) have reached epidemic levels in the United States and Western nations. In response to this public health calamity, the author of this paper presents and defends a novel bioethical argument: the consistency argument for outlawing SSBs (sugar-sweetened beverages) for child consumption (the “consistency argument”). This argument’s radical conclusion states that the government is justified in outlawing SSBs consumption for child (...) consumption. The reasoning is as follows: if one accepts that the physical harm caused by chronic alcohol consumption justifies the government outlawing alcoholic beverages for child consumption, and there is strong evidence that comparable physical harms result from chronic SSBs consumption, then, _mutatis mutandis_, the government is also justified in outlawing child consumption of SSBs. To support this argument, the author provides extensive evidence based on epidemiological observational studies, interventional studies, controlled trials, large meta-analyses, and the pathophysiology and biological mechanisms of action behind SSBs and chronic disease. Chronic consumption of large doses of SSBs and alcoholic beverages both drive the same diseases: obesity and insulin resistance, cardiovascular disease, hypertension, and cancer. Chronic SSB consumption carries the additional risk of Alzheimer’s disease, dementia, and depression. The author concludes this paper by considering prominent objections to the consistency argument, and then demonstrating that each objection is unsound. (shrink)

Research in infection biology aims to understand the complex nature of host–pathogen interactions. While this knowledge facilitates strategies for preventing and treating diseases, it can also be intentionally misused to cause harm. Such dual-use risk is potentially high for highly pathogenic microbes such as Risk Group-3 (RG3) bacteria and RG4 viruses, which could be used in bioterrorism attacks. However, other pathogens such as influenza virus (IV) and enterohemorrhagic Escherichia coli (EHEC), usually classified as RG2 pathogens, also demonstrate high dual-use risk. (...) As the currently approved therapeutics against these pathogens are not satisfactorily effective, previous outbreaks of these pathogens caused enormous public fear, media attention and economic burden. In this interdisciplinary review, we summarize the current perspectives of dual-use research on IV and EHEC, and further highlight the dual-use risk associated with evolutionary experiments with these infectious pathogens. We support the need to carry out experiments pertaining to pathogen evolution, including to gain predictive insights on their evolutionary trajectories, which cannot be otherwise achieved with stand-alone theoretical models and epidemiological data. However, we also advocate for increased awareness and assessment strategies to better quantify the risks-versus-benefits associated with such evolutionary experiments. In addition to building public trust in dual-use research, we propose that these approaches can be extended to other pathogens currently classified as low risk, but bearing high dual-use potential, given the particular pressing nature of their rapid evolutionary potential. (shrink)

Mental health surveys are used extensively in epidemiological research worldwide. The ethical questions that arise regarding their risk of causing psychological distress or other potential harm have not been studied in the general population. We have investigated how study participants serving as controls in a population-based study perceived an anonymous postal questionnaire focusing on mental health and wellbeing. Parents were contacted from the Swedish Census Bureau as part of a larger follow-up study on palliative care conducted in 2001. Eligible parents (...) had a child of the same gender, year of birth and were from the same counties in Sweden as parents who had lost a child to cancer. Five percent reported being negatively affected. The principle negative effect on participants was that self-reflection reminded them of their difficulties. Of the 418 respondents, 52% reported that they were positively affected by study participation and 95% perceived the inquiry as valuable. These findings support the use of population-based controls in future research. (shrink)

The argument from inductive risk claims that judgments about the moral severity of errors are relevant to decisions about what should count as sufficient evidence for accepting claims. While this idea has been explored in connection with evidence required for the approval of pharmaceuticals, the role of inductive risk in the post-approval process has been largely neglected. In this article, we examine the ethics of inductive risk in connection with revisions to the product monograph for OxyContin in Canada, which understates (...) the risks of addiction and abuse associated with this drug. Using the concept of inductive risk, we consider what evidence should have been sufficient for Health Canada to revise the product monograph for OxyContin. Given the stakes involved, we argue that a less strict standard of evidence would have been appropriate, yet HC in fact took the opposite course, insisting upon a higher standard of evidence than it normally requires. In addition to providing a novel perspective on the opioid crisis in Canada, this article contributes to existing philosophical work by demonstrating that inductive risks in the post-approval stage are important and linked to pre-approval inductive risks. (shrink)

Lockdowns were a morally and medically appropriate anti-contagion policy to stop the spread of Covid. However, lockdowns came with considerable costs. Specifically, lockdowns imposed harms and losses upon the young in order to benefit the elderly, who were at the highest risk of severe illness and death from Covid. This represented a shifting of the (epidemiological) burden of Covid for the elderly to a systemic burden of lockdown upon the young. This article argues that even if lockdowns were a morally (...) permissible response to Covid, the harms and losses they imposed on the young ground a claim of compensation. I defend an intergenerational compensation argument that defends a claim for an egalitarian intergenerational transfer to compensate the young for the harms of lockdown. (shrink)

On November 14, 1996, an in-depth report on the recruiting and testing practices of Lilly Pharmaceuticals appeared in the Wall Street Journal. Laurie Cohen reported that most pharmaceutical companies had difficulty recruiting healthy subjects to participate in testing of “untried and potentially dangerous” drugs. These companies often had to pay subjects up to $250 a day to ensure adequate enrollment, and some even gave referral bonuses to doctors who sent potential subjects their way. Cohen then exposed how Lilly was (...) able to keep costs down: by recruiting homeless alcoholics to serve as research guinea pigs. “In many ways,” Cohen reported, “the practice is mutually beneficial. For Lilly, it is efficient and limits the risk that subjects will sue if harmed by an experiment or divulge particulars of a drug.” And the subjects “get several weeks or months of free room and board, and in interviews they express voluble gratitude for what they often call easy money.”. (shrink)

Much of the contemporary debate about the propriety of non-therapeutic circumcision of male infants and boys revolves around the question of risks vs. benefits. With its headline conclusion that the benefits outweigh the risks, the current circumcision policy of the American Academy of Pediatrics [AAP] (released 2012) is a typical instance of this line of thought. Since the AAP states that it cannot assess the true incidence of complications, however, critics have pointed out that this conclusion is unwarranted. In this (...) paper it is argued that the AAP’s conclusion is untenable not only for empirical reasons related to lack of data, but also for logical and conceptual reasons: the concept of risk employed—risk of surgical complications—is too narrow to be useful in the circumcision debate. Complications are not the only harms of circumcision: the AAP and other parties debating the pros and cons of circumcision should conceptualize their analysis more broadly as risk of harm vs. prospect of benefit, thereby factoring in the value of the foreskin to the individual and the physical and ethical harms of removing it from a non-consenting child. (shrink)

Background: Evidence suggesting adverse drug reactions often emerges unsystematically and unpredictably in form of anecdotal reports, case series and survey data. Safety trials and observational studies also provide crucial information regarding the (un-)safety of drugs. Hence, integrating multiple types of pharmacovigilance evidence is key to minimising the risks of harm. Methods: In previous work, we began the development of a Bayesian framework for aggregating multiple types of evidence to assess the probability of a putative causal link between drugs and side (...) effects. This framework arose out of a philosophical analysis of the Bradford Hill Guidelines. In this article, we expand the Bayesian framework and add “evidential modulators,” which bear on the assessment of the reliability of incoming study results. The overall framework for evidence synthesis, “E-Synthesis”, is then applied to a case study. Results: Theoretically and computationally, E-Synthesis exploits coherence of partly or fully independent evidence converging towards the hypothesis of interest (or of conflicting evidence with respect to it), in order to update its posterior probability. With respect to other frameworks for evidence synthesis, our Bayesian model has the unique feature of grounding its inferential machinery on a consolidated theory of hypothesis confirmation (Bayesian epistemology), and in allowing any data from heterogeneous sources (cell-data, clinical trials, epidemiological studies), and methods (e.g., frequentist hypothesis testing, Bayesian adaptive trials, etc.) to be quantitatively integrated into the same inferential framework. Conclusions: E-Synthesis is highly flexible concerning the allowed input, while at the same time relying on a consistent computational system, that is philosophically and statistically grounded. Furthermore, by introducing evidential modulators, and thereby breaking up the different dimensions of evidence (strength, relevance, reliability), E-Synthesis allows them to be explicitly tracked in updating causal hypotheses. (shrink)

What meaning does epidemiological evidence have for the individual? In evidence-based medicine, epidemiological evidence measures the patient’s risk of the outcome or the change in risk due to an intervention. The patient’s risk is commonly understood as an individual probability. The problem of understanding epidemiological evidence and risk thus becomes the challenge of interpreting individual patient probabilities. I argue that the patient’s risk is interpreted ontically, as a propensity. After exploring formidable problems with this interpretation in the medical context, I (...) propose an epistemic reinterpretation of individual patient probabilities as credences. On this view, epidemiological evidence informs medical uncertainty. (shrink)

Medicine, Power, and the Law demonstrates that criminal and civil justice interact with medicine and public health more than is presently understood. The book focuses on the role of healthcare practitioners and an array of other professionals across industries in identifying wrongdoers, reporting behavior, and testifying on behalf of the state or government agencies. It also covers circumstances in which law enforcement relies on medicine for evidence or support in ways that compromise medical ethics. By reporting or testifying as experts, (...) a range of people, from specialist pediatricians to flight attendants, can have a life-changing impact on individuals in the name of public health or medicine. People who work in hospitals, social work settings, and even airlines, often contribute to wrongful and aggressive criminal and civil actions against society's most vulnerable people, including parents, older adults, and people living with poverty. The book explores a number of examples, including police use of medicine as a restraint or the collection of blood as evidence and the risks of opting out of certain scientific discoveries, such as pharmaceuticals. It describes the harms that may come to those who engage in suboptimal but generally heretofore legal child-raising behaviors, and people opting to live independently as older adults. These can lead to civil and criminal charges when noticed by those in a position of power. Medicine, Power, and the Law is an important contribution for researchers and practitioners in medicine, the law, and the expanding field of bioethics. (shrink)

Applying a medical conception of toxicity to speech practices, this paper calls for an epidemiology of discursive toxicity. Toxicity highlights the mechanisms by which speech acts and discursive practices can inflict harm, making sense of claims about harms arising from speech devoid of slurs, epithets, or a narrower class I call ‘deeply derogatory terms.’ Further, it highlights the role of uptake and susceptibility, and so suggests a framework for thinking about damage variation. Toxic effects vary depending on one’s epistemic (...) position, access, and authority. An inferentialist account of discursive practice plus a dynamic view of the power of language games offers tools to analyze the toxic power of speech acts. A simple account of language games helps track changes in our discursive practices. Identifying patterns contributes to an epidemiology of toxic speech, which might include tracking increasing use of derogatory terms, us/them dichotomization, terms of isolation, new essentialisms, and more. Using this framework, I analyze some examples of speech already said to be toxic, working with a rough concept of toxicity as poison. Finally, exploring discursive toxicity pushes us to find ways that certain discursive practices might “inoculate” one to absorbing toxic messages, or less metaphorically, block one’s capacity to make toxic inferences, take deontic stances that foster toxicity, etc. (shrink)

Subjects in studies on humans are used as a means of conducting the research and achieving whatever good would justify putting them at risk. Accordingly, consent must normally be obtained before subjects are exposed to any substantial risks to their welfare. Bystanders are also often put at risk, but they are not used as a means. Accordingly—or so I argue—consent is more often unnecessary before bystanders are exposed to similar substantial risks to their welfare.

The debate about the ethics of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) often focuses on the assumptions made by the different parties involved, failing to note the lack of a necessary connection between those assumptions and the main criticism of the study—that the parents appear to have been poorly informed. The fact that the target ranges of oxygen saturation (SpO2) used in SUPPORT were within the range recommended as an appropriate “standard of care” does not mean that (...) the infants randomized to one of two restricted SpO2 ranges received the same treatment they would have received outside of the trial. The corresponding observation that randomization altered the potential harms to which an individual infant was exposed does not mean that the risks of being in SUPPORT were greater than or in addition to the risks associated with usual care. The argument that parents should have been better informed about these potential harms does not entail the (incorrect) assumption that neonatal clinicians make individualized treatment decisions rather than follow a standardized protocol when adjusting the level of oxygen a preterm infant receives. The fact that parents are unaware of the trade‐off clinicians make between these potential harms when establishing such a protocol does not justify the failure to adequately inform parents about the purpose of SUPPORT and the risks and harms that were involved. (shrink)

The U.S. Food and Drug Administration's drug advisory committees provide expert assessments of the safety and efficacy of new therapies considered for approval. A committee hears from a variety of speakers, from six groups, including voting members of the committee, FDA staff members, employees of the pharmaceutical company seeking approval of a therapy, patient and consumer representatives, expert speakers invited by the company, and public participants. The committees convene at the request of the FDA when the risks and harms (...) of novel products are not immediately clear, and their final decisions carry significant weight, as most therapies that receive advisory committee approval are subsequently approved by the FDA. In recent years, across a series of diverse publications, the financial conflicts of interest of each category of participants in the meetings have been investigated. Here, we summarize these findings and their ethical implications, focusing on the FDA Oncologic Drugs Advisory Committee, and we suggest ways to move toward more transparent and impartial advisory committee meetings. (shrink)

An abundance of data unequivocally shows that exercise can be an effective tool in the fight against obesity and its associated co-morbidities. Indeed, physical activity can be more effective than widely-used pharmaceutical interventions. Whilst metformin reduces the incidence of diabetes by 31% (as compared with a placebo) in both men and women across different racial and ethnic groups, lifestyle intervention (including exercise) reduces the incidence by 58%. In this context, it is notable that a group of prominent medics and (...) exercise scientists recently sent a well-publicised letter to the General Medical Council and Medical Schools Council calling for the introduction of evidence-based lifestyle education into all medical curricula. The letter warns that there is a lack of understanding of the impact that exercise and nutrition can have on physical health amongst doctors. In the absence of an educational overhaul, the signatories warn that the government is likely to fail to reach its goal of preventing tens of thousands of premature deaths from heart disease and cancer by 2020. Whilst we agree with the need to address this apparent lack of understanding, we argue that the ethical justification of doing so is not limited to this broadly beneficence-based justification. There is also a justification grounded in the duty of non-maleficence, that is, the duty to avoid unreasonably harming patients. This duty requires that doctors refrain from (i) preventing patients from undergoing beneficial treatment without good reason, (ii) exposing patients to unreasonable risks and (iii) reducing the therapeutic effect of an effective medical intervention. This requires an understanding of the physical impact of exercise. (shrink)