Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms (...) enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee. Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice. (shrink)

Volume 20, Issue 3, March 2020, Page 21-24.

The paper is dealing with the foundation of the Division for German Literature and Language at the Hebrew University of Jerusalem from the point of view of its first head, Prof. Stéphane Mosès.

What is it about conspiracies that make them so attractive and easy to believe yet difficult to debunk? Is the epistemological process of debunking the best or only pedagogy for dislodging conspiracies? Are all conspiracies irrational and/or unverifiable? To what extent, if at all, do today’s social media conspiracies differ from conspiracies in the past?

The conception of saviour siblings using preimplantation genetic diagnosis coupled with human leukocyte antigen typing or HLA typing alone is controversial and receives a wide divergence of legal responses among countries around the world. The resulting child conceived through this procedure is dubbed a ‘saviour sibling’ as the child can potentially act as a compatible donor for an elder ailing sibling who needs a haematopoietic stem cell transplantation. At present, the acceptability of this procedure in Malaysia is ambiguous as there (...) is no specific statute governing assisted reproductive technology, and the guideline issued by the Malaysian Medical Council does not expressly address this issue. The ethical arguments relating to the conception of saviour siblings in the current literature are mainly thought to reflect a liberal viewpoint which is predominantly Western in nature. This paper seeks to explore the perception of selected key stakeholders on the acceptability of and ethical concerns related to this procedure in the Malaysian context. The findings indicate that stakeholders generally support the conception of saviour siblings and some of their concerns echo the Western viewpoint. Interestingly, many were highly anxious about its economic implication, which is rarely discussed in the current literature on saviour siblings. (shrink)

BAIARDI JM, BRUSH BL and LAPIDES S. Nursing Inquiry 2010; 17: 289–296 Common issues, different approaches: strategies for community–academic partnership developmentCommunities around the United States face many challenging health problems whose complexity makes them increasingly unresponsive to traditional single‐solution approaches. Multiple approaches have considered ways to understand these health issues and devise interventions that work. One such approach is community‐based participatory research. This article describes the development of a new collaborative partnership between a school of nursing and an urban social (...) service agency using community‐based participatory research as a framework. We describe the partnership’s evolution and process of data collection and analysis and evaluate the outcomes of both. We argue that community‐based participatory research involves partnerships at its core whose members, both as individuals and part of the collaboration, must be committed and nimble in the face of shifting and challenging health and social problems, recognize common issues and concerns across the boundaries of community and academia, and respect each other’s different approaches and expertise. (shrink)

In a pioneering study Georges Duby showed how the system of justice that had prevailed in the Carolingian era ceased to function in the Mâconnais of the tenth century. His observations about the breakdown of public institutions opened up a new field of research, for they suggested the development in the tenth century of a unique set of judicial institutions and practices, different in kind from the traditional public order of the Roman and Roman-influenced Carolingian worlds. This was an important (...) change, and a number of scholars turned their attention to the developments described by Duby. (shrink)

Self-tracking devices point to a future in which individuals will be more involved in the management of their health and will generate data that will benefit clinical decision making and research. They have thus attracted enthusiasm from medical and public health professionals as key players in the move toward participatory and personalized healthcare. Critics, however, have begun to articulate a number of broader societal and ethical concerns regarding self-tracking, foregrounding their disciplining, and disempowering effects. This paper has two aims: first, (...) to analyze some of the key promises and concerns that inform this polarized debate. I argue that far from being solely about health outcomes, this debate is very much about fundamental values that are at stake in the move toward personalized healthcare, namely, the values of autonomy, solidarity, and authenticity. The second aim is to provide a framework within which an alternative approach to self-tracking for health can be developed. I suggest that a practice-based approach, which studies how values are enacted in specific practices, can open the way for a new set of theoretical questions. In the last part of the paper, I sketch out how this can work by describing various enactments of autonomy, solidarity, and authenticity among self-trackers in the Quantified Self community. These examples show that shifting attention to practices can render visible alternative and sometimes unexpected enactments of values. Insofar as these may challenge both the promises and concerns in the debate on self-tracking for health, they can lay the groundwork for new conceptual interventions in future research. (shrink)

Since the outbreak of COVID-19, governments have turned their attention to digital contact tracing. In many countries, public debate has focused on the risks this technology poses to privacy, with advocates and experts sounding alarm bells about surveillance and mission creep reminiscent of the post 9/11 era. Yet, when Apple and Google launched their contact tracing API in April 2020, some of the world’s leading privacy experts applauded this initiative for its privacy-preserving technical specifications. In an interesting twist, the tech (...) giants came to be portrayed as greater champions of privacy than some democratic governments. This article proposes to view the Apple/Google API in terms of a broader phenomenon whereby tech corporations are encroaching into ever new spheres of social life. From this perspective, the advantage these actors have accrued in the sphere of the production of digital goods provides them with access to the spheres of health and medicine, and more worrisome, to the sphere of politics. These sphere transgressions raise numerous risks that are not captured by the focus on privacy harms. Namely, a crowding out of essential spherical expertise, new dependencies on corporate actors for the delivery of essential, public goods, the shaping of public policy by non-representative, private actors and ultimately, the accumulation of decision-making power across multiple spheres. While privacy is certainly an important value, its centrality in the debate on digital contact tracing may blind us to these broader societal harms and unwittingly pave the way for ever more sphere transgressions. (shrink)

This article tracks Corporate Social Responsibility (CSR) as an emergent organizational process that places the employee at its center. Predominantly, research on CSR tends to focus on external pressures and outcomes leading to a neglect of CSR as a dynamic and developing process that relies on the involvement of the employee as a major stakeholder in its co-creation and implementation. Utilizing case study data drawn from a study of a large multinational energy company, we explore how management relies on employees' (...) interaction with CSR as the process of initiation → implementation → maturation develops. Employee involvement grows from a minor element in the CSR initiation stage to a vital contributory factor in CSR's success in the later stages of the process. The article offers new insights into a processual and interactional approach to CSR that accounts for the actions of different actors involved at each stage. Most unusually, it also recognizes the dual impact this has on broader issues concerning the management and involvement of employees through CSR actions, and gaining legitimacy in the eyes of not only external stakeholders but internal too. (shrink)

Contemporary realist theories of value claim to be compatible with natural science. In this paper, I call this claim into question by arguing that Darwinian considerations pose a dilemma for these theories. The main thrust of my argument is this. Evolutionary forces have played a tremendous role in shaping the content of human evaluative attitudes. The challenge for realist theories of value is to explain the relation between these evolutionary influences on our evaluative attitudes, on the one hand, and the (...) independent evaluative truths that realism posits, on the other. Realism, I argue, can give no satisfactory account of this relation. On the one hand, the realist may claim that there is no relation between evolutionary influences on our evaluative attitudes and independent evaluative truths. But this claim leads to the implausible skeptical result that most of our evaluative judgements are off track due to the distorting pressure of Darwinian forces. The realist’s other option is to claim that there is a relation between evolutionary influences and independent evaluative truths, namely that natural selection favored ancestors who were able to grasp those truths. But this account, I argue, is unacceptable on scientific grounds. Either way, then, realist theories of value prove unable to accommodate the fact that Darwinian forces have deeply influenced the content of human values. After responding to three objections, the third of which leads me to argue against a realist understanding of the disvalue of pain, I conclude by sketching how antirealism is able to sidestep the dilemma I have presented. Antirealist theories of value are able to offer an alternative account of the relation between evolutionary forces and evaluative facts —
an account that allows us to reconcile our understanding of evaluative truth with our understanding of the many non-rational causes that have played a role in shaping our evaluative judgements. (shrink)

Methodologists in political science have advocated for causal process tracing as a way of providing evidence for causal mechanisms. Recent analyses of the method have sought to provide more rigorous accounts of how it provides such evidence. These accounts have focused on the role of process tracing for causal inference and specifically on the way it can be used with case studies for testing hypotheses. While the analyses do provide an account of such testing, they pay little attention to the (...) narrative elements of case studies. I argue that the role of narrative in case studies is not merely incidental. Narrative does cognitive work by both facilitating the consideration of alternative hypotheses and clarifying the relationship between evidence and explanation. I consider the use of process tracing in a particular case (the Fashoda Incident) in order to illustrate the role of narrative. I argue that process tracing contributes to knowledge production in ways that the current focus on inference tends to obscure. (shrink)

New biotechnologies have propelled the question of what it means to be human - or posthuman - to the forefront of societal and scientific consideration. This volume provides an accessible, critical overview of the main approaches in the debate on posthumanism, and argues that they do not adequately address the question of what it means to be human in an age of biotechnology. Not because they belong to rival political camps, but because they are grounded in a humanist ontology that (...) presupposes a radical separation between human subjects and technological objects. The volume offers a comprehensive mapping of posthumanist discourse divided into four broad approaches-two humanist-based approaches: dystopic and liberal posthumanism, and two non-humanist approaches: radical and methodological posthumanism. The author compares and contrasts these models via an exploration of key issues, from human enhancement, to eugenics, to new configurations of biopower, questioning what role technology plays in defining the boundaries of the human, the subject and nature for each. Building on the contributions and limitations of radical and methodological posthumanism, the author develops a novel perspective, mediated posthumanism, that brings together insights in the philosophy of technology, the sociology of biomedicine, and Michel Foucault's work on ethical subject constitution. In this framework, technology is neither a neutral tool nor a force that alienates humanity from itself, but something that is always already part of the experience of being human, and subjectivity is viewed as an emergent property that is constantly being shaped and transformed by its engagements with biotechnologies. Mediated posthumanism becomes a tool for identifying novel ethical modes of human experience that are richer and more multifaceted than current posthumanist perspectives allow for. The book will be essential reading for students and scholars working on ethics and technology, philosophy of technology, poststructuralism, technology and the body, and medical ethics. (shrink)

A much‐debated series of articles in the New England Journal of Medicine in May 2015 labeled the pharmaceutical industry's critics “pharmascolds.” Having followed the debate for two decades, I count myself among the scolds. The weight of the evidence overwhelmingly supports the claim that pharmaceutical policy no longer serves the public interest; the central questions now are how this happened and what to do about it. I approached three of the most recent books on the industry with these questions in (...) mind. Deadly Medicine and Organized Crime (CRC Press, 2013), by Peter Gøtzsche, Bad Pharma (Faber & Faber, 2013), by Ben Goldacre, and Good Pharma (Palgrave MacMillan, 2015), by Donald Light and Antonio Maturo, all situate their critical assessments in high‐income countries globally, depicting the problem of pharmaceuticals as too many drugs approved with too little evidence, causing too many needless deaths, and prices spiraling to heights unimaginable just a decade ago. Light and Maturo, while no less critical of the status quo than Gøtzsche and Goldacre, take a different tack: they detail the success of an alternative model for pharmaceutical research, the Mario Negri Institute in Italy, citing it as proof positive that we can indeed defy capitalism's profit imperative. (shrink)

Women’s health activists laid the groundwork for passage of the law that created the U.S. Food and Drug Administration in 1906. The pharmaceutical and food industries fought regulatory reforms then and continue to do so now. We examine public health activism in the Progressive Era, the postwar era and the present day. The women’s health movement began in the 1960s, and criticized both the pharmaceutical industry and the medical establishment. In the 1990s, patient advocacy groups began accepting industry funds; thousands (...) of commercially-funded groups now dominate the advocacy landscape. As pharma funding became normalized, concerns arose regarding a) the lack of transparency and public accountability regarding funding, b) the distortion of groups’ agendas, and c) the ability of pharma-funded groups to dominate the discourse and override less well-resourced patient and health advocacy groups. Although industry-funded groups argue that funding allows them to provide useful services, the trade-off in health risks, exorbitant prices and distorted information is far too high. Sincerity is beside the point; patients and the industry have differing interests when it comes to drug safety and efficacy, drug information and drug prices. A growing resistance movement is asserting the values of its activist predecessors and opposing the prevailing culture of pharma-funded advocacy. (shrink)

The lottery paradox has been discussed widely. The standard solution to the lottery paradox is that a ticket holder is justified in believing each ticket will lose but the ticket holder is also justified in believing not all of the tickets will lose. If the standard solution is true, then we get the paradoxical result that it is possible for a person to have a justified set of beliefs that she knows is inconsistent. In this paper, I argue that the (...) best solution to the paradox is that a ticket holder is not justified in believing any of the tickets are losers. My solution avoids the paradoxical result of the standard solution. The solution I defend has been hastily rejected by other philosophers because it appears to lead to skepticism. I defend my solution from the threat of skepticism and give two arguments in favor of my conclusion that the ticket holder in the original lottery case is not justified in believing that his ticket will lose. (shrink)

Arthur Fine's Natural Ontological Attitude (NOA) is intended to provide an alternative to both realism and antirealism. I argue that the most plausible meaning of "natural" in NOA is "nonphilosophical," but that Fine comes to NOA through a particular conception of philosophy. I suggest that instead of a natural attitude we should adopt a philosophical attitude. This is one that is self-conscious, pragmatic, pluralistic, and sensitive to context. I conclude that when scientific realism and antirealism are viewed with a philosophical (...) attitude there are still legitimate philosophical questions to address. (shrink)

Psychologist Sharon Lamb and philosopher Jeffrie Murphy argue that forgiveness has been accepted as a therapeutic strategy without serious, critical examination. Chapters by both psychologists and philosophers ask: Why is forgiveness so popular now? What exactly does it entail? When might it be appropriate for a therapist not to advise forgiveness? When is forgiveness in fact harmful?

A better appreciation of the material, distributed quality of human agency can illuminate subtle dynamics of domination and oppression and reveal resources for potentially liberatory political action. Materialist accounts of agency nevertheless pose challenges to the notion of personal responsibility that is so crucial to political obligation and democratic citizenship. To guard against this danger, we need to sustain the close connection between agency and a sense of selfhood that is individuated, reflexive, and responsive to norms. Yet we should acknowledge (...) that reflexive selfhood is not the whole of individual agency for the sources of agency extend beyond the individual herself. We also need to recognize the ways that both reflexivity and norm-responsiveness are themselves embodied capacities. When properly conceived, a materialist view of agency can increase awareness of our oftenunwitting contributions to systematic inequalities of power and extend our political responsibilities in emancipatory directions, thus holding great promise for democratic life. (shrink)

In many ways set theory lies at the heart of modern mathematics, and it does powerful work both philosophical and mathematical – as a foundation for the subject. However, certain philosophical problems raise serious doubts about our acceptance of the axioms of set theory. In a detailed and original reassessment of these axioms, Sharon Berry uses a potentialist approach to develop a unified determinate conception of set-theoretic truth that vindicates many of our intuitive expectations regarding set theory. Berry further (...) defends her approach against a number of possible objections, and she shows how a notion of logical possibility that is useful in formulating Potentialist set theory connects in important ways with philosophy of language, metametaphysics and philosophy of science. Her book will appeal to readers with interests in the philosophy of set theory, modal logic, and the role of mathematics in the sciences. (shrink)

Political respect for nature is an important part of cultivating a more emancipatory and ecologically sustainable politics. As a political principle, it can supplement respect for persons with institutional mechanisms that formally constrain how human power may be exercised over non-human beings and things and that require us to use our power in ways that are attentive to nature’s well-being along with our own. Moreover, when internalized by citizens as part of their shared political ethos and public culture, respect for (...) nature has the potential to protect against the abuse of power in our interpersonal relations with Earth’s non-human parts. Political respect for nature means acknowledging that non-human beings and things count, that they deserve to be treated according to standards of right and that there are principled limits to how human power may be exercised over them. It means formalizing these constraints in the basic structure of society and fostering a public culture of self-restraint and responsiveness. (shrink)

Case study research was once the primary methodology of research in political science. The shift to other methodologies in recent decades suggests has led to a devaluing of these approaches. This article explores six roles for case studies in the social sciences and argues that an understanding of the multiple aims of research supports a methodological pluralism that includes case study research.

The datafication and digitalization of health and medicine has engendered a proliferation of new collaborations between public health institutions and data corporations like Google, Apple, Microsoft and Amazon. Critical perspectives on these new partnerships tend to frame them as an instance of market transgressions by tech giants into the sphere of health and medicine, in line with a “hostile worlds” doctrine that upholds that the borders between market and non-market spheres should be carefully policed. This article seeks to outline the (...) limitations of this common framing for critically understanding the phenomenon of the Googlization of health. In particular, the mobilization of a diversity of non-market value statements in the justification work carried out by actors involved in the Googlization of health indicates the co-presence of additional worlds or spheres in this context, which are not captured by the market vs. non-market dichotomy. It then advances an alternative framework, based on a multiple-sphere ontology that draws on Boltanski and Thevenot’s orders of worth and Michael Walzer’s theory of justice, which I call a normative pragmatics of justice. This framework addresses both the normative deficit in Boltanski and Thevenot’s work and provides an important emphasis on the empirical workings of justice. Finally, I discuss why this framework is better equipped to identify and to address the many risks raised by the Googlization of health and possibly other dimensions of the digitalization and datafication of society. (shrink)

In this paper I will argue that (principled) attempts to ground a priori knowledge in default reasonable beliefs cannot capture certain common intuitions about what is required for a priori knowledge. I will describe hypothetical creatures who derive complex mathematical truths like Fermat’s last theorem via short and intuitively unconvincing arguments. Many philosophers with foundationalist inclinations will feel that these creatures must lack knowledge because they are unable to justify their mathematical assumptions in terms of the kind of basic facts (...) which can be known without further argument. Yet, I will argue that nothing in the current literature lets us draw a principled distinction between what these creatures are doing and paradigmatic cases of good a priori reasoning (assuming that the latter are to be grounded in default reasonable beliefs). I will consider, in turn, appeals to reliability, coherence, conceptual truth and indispensability and argue that none of these can do the job. (shrink)

This volume takes two different, albeit intertwined approaches. The first concerns a reformulation of aesthetics in education—one which highlights the sensory dimensions of educational experience. The second concerns a turn to the body and the senses as that which is deeply involved in practices of teaching and learning.

For the past 15 years, scholars in education have focused on Levinas’s work largely in terms of his understanding of alterity, of the self-Other relation, of ethics as ‘first philosophy’ and the significance these concepts have on rethinking educational theory and practice. What I do in this paper, by way of method, is to start from a slightly different place, from the assertion that there is indeed something ‘new’ to be explored in Levinas’s philosophy – both in terms of ideas (...) to be found within his work, and also in terms of the demands educational ideas and practices place on his work from without. That is, how does the actual, lived specificity of educational encounters occasion a different set of questions than one would otherwise pose if thinking only from within the discipline of philosophy, or from a purely theoretical point of view? In light of this, this paper explores Levinas’s ideas of sensibility, materiality, and embodiment. I see these not simply as supports for his ethical thought, but as the very core of incarnation without which his ethics makes no sense. I propose that these ideas are quintessentially pedagogical aspects of his thought – that is, they are always already rooted in a relational context of change and alteration of the subject. (shrink)

In this article, I discuss a trivialization worry for Hartry Field’s official formulation of the access problem for mathematical realists, which was pointed out by Øystein Linnebo (and has recently been made much of by Justin Clarke-Doane). I argue that various attempted reformulations of the Benacerraf problem fail to block trivialization, but that access worriers can better defend themselves by sticking closer to Hartry Field’s initial informal characterization of the access problem in terms of (something like) general epistemic norms of (...) coincidence avoidance. (shrink)

Political science research, particularly in international relations and comparative politics, has increasingly become dominated by statistical and formal approaches. The promise of these approaches shifted the methodological emphasis away from case study research. In response, supporters of case study research argue that case studies provide evidence for causal claims that is not available through statistical and formal research methods, and many have advocated multimethod research. I propose a way of understanding the integration of multiple methodologies in which the causes sought (...) in case studies are treated as singular causation and contingent on a theoretical framework. (shrink)

The Idea of Disability in the Eighteenth Century is a wide-ranging collection of essays that explores philosophy, biography, and texts about and by disabled people living in the eighteenth century. The book, which introduces and affirms the notion that disability studies predates most United States and United Kingdom findings by more than a hundred years, will be of interest to philosophers, historians, sociologists, and literary scholars.

A Brief History of Moscovia is regarded as a minor, slightly odd composition within the Milton canon. Mostly completed before his total blindness in 1652, it stands in an awkward relationship to his other works, being largely composed of extracts from previous writers. This essay considers Milton's selection of factual content as well as his subtle deviations, at times, from his sources? wording. Milton takes us on a journey beginning with exterior landscapes and moves to graphic anthropological details, in the (...) final chapters shifting from geography to history. All these elements gradually accrue moral emphases, producing not a neutral account but an ethical critique in terms familiar from other Miltonic works, with some patriotic bias. Using R. D. Bedford's superb essay as the starting point, it explores Milton's language at the juncture of statement and evocation. Approaching nearer to the Far Eastern frontier with Cathay, one enters a mysterious realm. Here, the exotic and oriental fire Milton's descriptive imagination. In this combination of knowledge-based detail, moral energy and imaginative and poetic suggestion, Moscovia is in some ways a typically Miltonic work. (shrink)