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)

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)

The governance of nanotechnology seeks to limit its risks, without constraining opportunities. The literature on the effectiveness of approaches to governance has neglected approaches that impact directly on the behavior of a researcher. We analyze the effectiveness of legal regulations versus regulation via self-commitment. Then, we refine this model by analyzing competition and autonomy as key contingency factors. In the first step, qualitative interviews with nanotechnology researchers are conducted to reflect this model. In the second step, its empirical relevance is (...) tested using a survey of 90 nanotech researchers. The results indicate that legal regulations, as well as self-commitment to an informal CoC reduce the scope of behavior. Finally, that competition and autonomy affect the relative strength of these governance factors. (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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

Human infection challenge studies 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 assessments. Modelling will be particularly useful in comparing potential benefits and risks of HCS with those of vaccine field trials under different epidemiological conditions and 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)

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)

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)

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)

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)

According to Jonathan Quong’s _moral status account_ of liability to defensive harm, an agent is liable to defensive harm only when she mistakenly treats others as if their moral status is diminished (for example, as if they lack a right that they in fact possess). Quong argues that, by the lights of the moral status account, a conscientious driver (Driver) who faultlessly threatens to kill Pedestrian is not liable to defensive harm. Quong argues that Driver’s action is evidence-relative permissible, despite (...) the risks it imposes, because the general practice of prudent driving is permissible. The practice is permissible because (a) its risks do not disproportionately fall on some groups rather than others, (b) the threatened harms are incidental, and (c) the risk that driving imposes is acceptable in light of the benefits everyone derives from driving. Because the correct moral theory tells us that prudent driving is permissible, Pedestrian lacks a right that Driver refrain from driving. Hence, Driver does not, by driving, treat Pedestrian as lacking a right that Pedestrian in fact possesses. Driver is not liable to defensive force. I argue, against Quong, that cost–benefit analyses of types of risky activity cannot justify individual tokens of risk imposition. Actions that risk incidentally harming others must be justified by the prospective benefits of that token action. Hence, Driver’s imposition of risk on Pedestrian cannot be justified by the benefits of the general practice of driving. I argue that the permissibility of Driver’s imposing risk on Pedestrian via prudent driving turns on whether Driver is willing to internalise at least the foreseeable costs of that risky action. One can lack a right that a person refrain from performing a risky action whilst possessing a right not to be harmed by that risky action. Even if Pedestrian cannot reasonably demand that Driver refrain from driving, she can reasonably demand that Driver refrain from forcing her to bear the costs of his driving. (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)

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)

In this study the theory of risk factors is discussed. The risk-concept is essential in cardiology and is, furthermore, important not only in medicine in general, but also and particularly in ecology. Since environmental risk factors endanger our health, ecological risks have to be taken as medical problems. If a factor or a set of factors is a necessary but not a sufficient condition for a disease we speak of a risk factor or of risk factors. Statistical analysis of risk (...) factors can be performed by multivariate methods. A method which is particularly useful for finding the most important of a set of risk factors, is discriminant analysis. (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.

In this paper we aim to demonstrate the enormous ethical complexity that is prevalent in child obesity cases. This complexity, we argue, favors a cautious approach. Against those perhaps inclined to blame neglectful parents, we argue that laying the blame for child obesity at the feet of parents is simplistic once the broader context is taken into account. We also show that parents not only enjoy important relational prerogatives worth defending, but that children, too, are beneficiaries of that relationship in (...) ways difficult to match elsewhere. Finally, against the backdrop of growing public concern and pressure to intervene earlier in the life cycle, we examine the perhaps unintended stigmatizing effects that labeling and intervention can have and consider a number of risks and potential harms occasioned by state interventions in these cases. (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)

This paper examines whether an agent becomes liable to defensive harm by engaging in a morally permissible but foreseeably risk-imposing activity that subsequently threatens objectively unjustified harm. It first clarifies the notion of a foreseeably risk-imposing activity by proposing that an activity should count as foreseeably risk-imposing if an agent may morally permissibly perform it only if she abides by certain duties of care. Those who argue that engaging in such an activity can render an agent liable to defensive harm (...) ground this liability in the luck egalitarian thought that we may justly hold individuals responsible for the consequences of their voluntary choices. Against this, I argue that a luck egalitarian commitment to holding people responsible cannot, by itself, ground liability to defensive harm. It can help ground such liability only against the backdrop of a distributively just society, and only if further considerations speak morally in favour of attaching certain well-defined costs to individuals’ risk-imposing choices. I conclude by suggesting that if an account of liability applies robustly across distributively just and unjust contexts alike, then what grounds an agent’s liability is plausibly not her responsibility for threatening objectively unjustified harm, but her culpability for doing so. (shrink)

Particular applications of Privacy by Design (PbD) have proven to be valuable tools to protect privacy in many technological applications. However, PbD is not as promising when applied to technologies used for surveillance. After specifying how surveillance and privacy are understood in this paper, I will highlight the shortcomings of PbD when applied to surveillance, using a web-scanning system for counter-terrorism purposes as an example. I then suggest reworking PbD into a different approach: the Minimum Harm by Design (MHbD) model. (...) MHbD differs from PbD principally in that it acknowledges that the potential harms of surveillance bear not only upon privacy but also values that define the very constitution of a society and its political character. MHbD aims to identify and systematise the different categories of such harms and links them to current theories on surveillance on the one hand and on possible design measures on the other. (shrink)

This essay answers two questions that continue to drive debate in moral and legal philosophy; namely, ‘Is a risk of harm a wrong?’ and ‘Is a risk of harm a harm?’. The essay’s central claim is that to risk harm can be both to wrong and to harm. This stands in contrast to the respective positions of Heidi Hurd and Stephen Perry, whose views represent prominent extremes in this debate about risks. The essay shows that there is at least one (...) category of risks – intentional impositions of risk on unconsenting agents – which can be both wrongful and harmful. The wrongfulness of these risks can be established when, on the balance of reasons, one ought not to impose them. The harmfulness of these risks can be established when the risks are shown to set back legitimate interests. In those cases where risks constitute a denial of the moral status of agents, risks set back agents’ interest in dignity. In these ways, the essay shows that there are instances when a risk can constitute both a wrong and a harm. (shrink)

Many activities impose risks of harm on other people. One such class of risks are those that individuals culpably impose on others, such as the risk arising from reckless driving. Do such risks in themselves constitute a harm, over and above any harm that actually eventuates? This paper considers three recent views that each answer in the affirmative. I argue that each fails to overcome what I call the ‘interference objection’. The risk of harm itself, whether taken as a subjective (...) or an objective risk, is unable to interfere with the interests of victims in order to constitute a harm. This does not mean that a risk of harm cannot itself be wrongful, but the conclusion does weaken the moral objectionableness of impositions of risks of harm. (shrink)

This paper investigates the circumstances under which it is morally permissible to impose non-negligible risks of serious harm on innocent civilians in order not to endanger tangible cultural heritage during armed conflict. Building on a previous account of the value of cultural heritage, it is argued that tangible cultural heritage is valuable because of how it contributes to valuable and meaningful human lives. Taking this account as the point of departure I examine the claim that commanders should be prepared to (...) risk lives of innocent civilians in order to avoid harm to tangible cultural heritage. I argue that imposing high risks of serious harm on innocent civilians without their consent constitutes a wrong that can be justified only in order to avoid a greater evil. It is then argued that damage to cultural heritage sites rarely constitutes the greater evil when weighed against the imposition of non-consensual risks of serious harm on innocent civilians, especially when the risk is substantial. Still, imposing substantial risks might be morally permissible under the condition that they are consensually imposed, even if they are not the lesser evil. However, I argue that even if one has reason to suspect that there are civilians who might consent to at least some significant risks in order to avoid damage to their cultural heritage, it is not clear that commanders should take this into account when deciding what to do. Unless all of those who are at risk consent, the fact that some of those whose lives are at risk consent to the risk of being killed do not make it morally permissible to impose this risk on the group as a whole. (shrink)

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)

Rowe has recently argued that pure risk of harm cannot itself be a harm. I respond to Rowe and argue that given an appropriate understanding of objective probabilities, pure objective risk of harm can itself be a harm.

Purpose: The research explored empirical evidence to assess the impact of cyber security and supply chain risk on digital operations in the UAE pharmaceutical industry. Methodology/Design/Approach: Based on responses from 243 personnel working at 14 pharmaceutical manufacturing companies in Dubai, data were examined for normality, instrument validity and regression analysis. Cyber security and SC risk on digital operations were explored by applying convenient sampling and descriptive and analytical research design. Findings: The findings validated the significant positive association between (...) cyber security and supply chain risk with digital operations. Research implications and Limitations: The research model was developed with three variables evaluated only on the pharmaceutical industry in Dubai. Future research should focus on multiple manufacturing industries by covering a larger geographic area. Practical implications: When suppliers are highly concentrated, customer-focused organisations with uncertain levels of digital transformation could improve their ability to manage supply chain risk by diversifying their clients. Pharmaceutical firms may require a greater focus on technology-based manufacturing firms to build and maintain customer trust. Originality Value: To illustrate how the pharmaceutical industry has explored the relationship between cyber security, supply chain risk and digital operations, the research highlights the significant and convoluted consequences of the relationship model that have not been previously considered. (shrink)

What is wrong with imposing pure risks, that is, risks that don’t materialize into harm? According to a popular response, imposing pure risks is pro tanto wrong, when and because risk itself is harmful. Call this the Harm View. Defenders of this view make one of the following two claims. On the Constitutive Claim, pure risk imposition is pro tanto wrong when and because risk constitutes diminishing one’s well-being viz. preference-frustration or setting-back their legitimate interest in autonomy. On the Contingent (...) Claim, pure risk imposition is pro tanto wrong when and because risk has harmful consequences for the risk-bearers, such as psychological distress. This paper argues that the Harm View is plausible only on the Contingent Claim, but fails on the Constitutive Claim. In discussing the latter, I argue that both the preference and autonomy account fail to show that risk itself is constitutively harmful and thereby wrong. In discussing the former, I argue that risk itself is contingently harmful and thereby wrong but only in a narrow range of cases. I conclude that while the Harm View can sometimes explain the wrong of imposing risk when risk itself is contingently harmful, it is unsuccessful as a general, exhaustive account of what makes pure imposition wrong. (shrink)

In current mental health care psychiatric conditions are defined as compilations of symptoms. These symptom-based disease categories have been severely criticised as contingent and boundless, facilitating the rise to epidemic proportions of such conditions as depression. In this article we look beyond symptoms and stress the role of epidemiology in explaining the current situation. By analysing the parallel development of cardiovascular disease and depression management in Finland, we argue, firstly, that current mental health care shares with the medicine of (...) chronic somatic conditions an attachment to risk factor epidemiology, which accentuates risk and prevention in disease management. However, secondly, due to the symptom-based definitions of psychiatric conditions, depression management cannot differentiate properly between symptoms, signs and risk factors such as, for example, cardiovascular medicine, but treats symptoms as signs or risk factors in contexts of treatment and prevention. Consequently, minor at-risk conditions have become difficult to separate from proper cases of depression. (shrink)

The most common solutions to the problem of high pharmaceutical prices have taken the form of regulations, price negotiations, or changes in drug coverage by insurers. These measures for the most part transfer the burden of drug expenditures between pharmaceutical companies and payers or between payers. The aim of this study is to propose an alternative model for the relationship between the main stakeholders involved in the price setting and purchasing of pharmaceuticals, one that encourages a more cooperative (...) approach. We draw from principles of ethics and health economics and apply them to the context of the pharmaceutical industry. The model prioritises two objectives, to make drugs financially accessible to the patients who need them, and to keep pharmaceutical companies viable and profitable. It is centered around the sharing of financial risk between the main stakeholders, which we describe as ‘enlightened risk sharing’. After establishing the foundations of this model, we expand on the type of policies that can follow these principles with current day examples. (shrink)

With the aim of ascertaining if child-to-parent offenders have impairments in the executive functions and psychological maladjustment, and to quantify the potential harm and epidemiology, a field study was designed. As for this, 76 juvenile offenders sentenced for child-to-parent violence were assessed in executive functions and psychological adjustment. The results showed valid responses for 75 juveniles and that data were not generally biased in line with defensiveness or malingering. In psychological adjustment, the results revealed a significantly higher maladjustment among (...) offenders on all the basic clinical scales with 23% more symptoms of hysteria than the normative population, 37% more of depressive symptoms, 44% more of hypochondriac symptoms, 68% more of psychopathic deviation symptoms, 46% more of paranoid symptoms, 26% more of psychasthenic symptoms, 24% more symptoms of schizophrenia, 17% more symptoms of hypomania, and 13% more symptoms of social introversion. Epidemiologically, the prevalence rates of clinical deterioration were significantly greater than expected in hypochondria, depression, hysteria, psychopathic deviation, paranoia, psychasthenia, and schizophrenia. As for the cognitive functions, the offenders exhibited impairments estimated at 62.0% in word reading, 47.9% in color naming, 45.8% in color-word, and 11.9% in interference and a significantly higher prevalence of caseness than expected in word reading, color naming, and color-word. The implications of the results for intervention are discussed. (shrink)

There are many risks involved in genetic engineering. The release of genetically altered organisms in the environment can increase human suffering, decrease animal welfare, and lead to ecological disasters. The containment of biotechnological material in laboratories and industrial plants contributes to the risk of accidental release, especially if the handling and storage are inadequate. The purely political dangers include intensified economic inequality, the possibility of large-scale eugenic programs, and totalitarian control over human lives. How should the acceptability of these risks (...) be determined? We argue that the assessment should be left to those who can be harmed by the decisions in question. Economic risks are acceptable, if they are condoned by the corporations and governments who take them. The risks imposed on laboratory personnel by the containment of dangerous materials ought to be evaluated by the laboratory personnel themselves. All other risks are more or less universal, and should therefore be assessed as democratically as possible. If risk-taking is based on the choices of those who can be harmed by the consequences, then, even if the undesired outcome is realized, the risk is acceptable, because it is embedded in their own system of ethical and epistemic values. (shrink)