Through expanded access protocols, the Food and Drug Administration (FDA) allows patients with serious or immediately life-threatening diseases access to experimental drugs outside the clinical trial setting when no satisfactory alternative treatment is available. While the FDA has established a mechanism for providing patients with unapproved drug access, the regulations do not require the pharmaceutical company to provide the drug. The drug company’s permission to use its experimental drug is a necessary prerequisite to using the FDA’s expanded access mechanism. Increasingly, (...) drug companies are coming under scrutiny regarding the programs governing that decision-making power. Historically, disclosing whether a company has an expanded access program, and whether or how it would respond to an expanded access request, has been left to discretion of the drug companies themselves. Few manufacturers publish adequate expanded access protocols. As a result, patients were provided with little insight into how companies evaluate expanded access requests and are naturally skeptical as to the ethical integrity of the process. The recently passed 21st Century Cures Act changes that practice by requiring drug companies to have, and make publically available, their expanded access procedures including criteria for evaluating and responding to patient requests. In this article, we contend that complying with the new transparency provisions will require drug companies to respond to several unresolved expanded access issues. Namely, how to reconcile a patient’s desire to access lifesaving experimental therapies alongside the company and society’s interest in the efficient development of new drugs. Even more challenging, how can companies devise practices for evaluating and processing expanded access requests that also fairly and equitably acknowledge those concerns? In addressing these questions, this article explores the legal, regulatory, business, and societal influences that have shaped expanded access policies and practices. From there, we provide companies a framework that balances appropriately the desires of individuals and gaining the requisite approvals ensure access not just for one person but for society. (shrink)

In this paper, we show that the question of the relative importance of innate characteristics and institutional arrangements in explaining human difference was vehemently contested in Britain during the first half of the nineteenth century. Thus Sir Francis Galton’s work of the 1860s should be seen as an intervention in a pre-existing controversy. The central figure in these earlier debates—as well as many later ones—was the philosopher and economist John Stuart Mill. In Mill’s view, human nature was fundamentally shaped by (...) history and culture, factors that accounted for most mental and behavioral differences between men and women and among people of different classes, nationalities, and races. Indeed, Mill’s whole program of social reform depended on the assumption that human differences were not fixed by nature. To identify the leading figures in these disputes about difference and the concrete context in which they occurred, we explore three debates in which Mill played a key role: over the capacities and rights of women, the viability of peasant proprietorship in India and Ireland, and the status of black labor in Jamaica. The last two draw our attention to the important colonial context of the nature–nurture debate. We also show that ideas that for us seem of a piece were not always linked for these earlier thinkers, nor did views on innateness necessarily have the political correlates that we now take for granted. (shrink)

In this paper we use the contemporary example of trans youth panics to introduce the notion of hermeneutical backlash, in which defenders of an established, unjust hermeneutical regime actively work to undermine and discredit hermeneutical liberation. We argue that the strategies and tropes of the trans youth panic illustrate a general propaganda vulnerability of epistemic liberation movements, and so are troubling for reasons that go beyond their application to trans youth. This exploration of a few specific cases of hermeneutical liberation (...) and hermeneutical backlash calls attention to the need for further theoretical work on the dynamics of struggles for hermeneutical justice. (shrink)

This book measures the current institutional and political realities surrounding globalization against philosophical ideals.

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of (...) research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance. (shrink)

Research has demonstrated that feeling-of-knowing judgments are affected by the amount of accessible information related to an inaccessible target. Further, studies have demonstrated that, in some situations, FOK judgment magnitude is not only related to the amount of accessed features, but also the correctness of those features . The present study examined the conditions under which the correctness of features would influence FOK judgment magnitude. We hypothesized that accuracy of retrieved features would influence FOK judgments, but only in situations where (...) semantically meaningful information was accessible. In three experiments, we manipulated accessibility of semantic information. In all experiments, the quantity, or amount of retrieved partial information had a greater impact on FOK judgments than the accuracy of that information. However, in situations where semantic information was accessible, accuracy of retrieved semantic features also influenced FOK judgment magnitude, and later recognition. (shrink)

Throughout the Middle Ages the expectation of eventual Jewish conversion lay at the center of traditional Christian justifications for protecting the Jewish populations which lived within their midst. St. Augustine and later Pope Gregory the Great enunciated a rationale for Christian protection of Jews, based loosely on Romans 11.25–29, that stressed the historical importance of the Jews as living witnesses to the Old Testament prophecies that confirmed Jesus' messiahship and that foresaw the Jews' eventual conversion to Christianity as a harbinger (...) of the end of days. As has been frequently pointed out, however, this was a theological view formulated much more for a Christian audience than a Jewish one. Nor was it a view that encouraged general campaigns directed at converting Jews en masse to Christianity. (shrink)

This book is a qualitative, interpretive, phenomenological, and interdisciplinary, examination of food and food practices and their meanings in the modern world. Each chapter thematically focuses upon a particular food practice and on some key details of the examined practice, or on the practice’s social and cultural impact.

In a study examining the effects of time of day on problem solving, participants solved insight and analytic problems at their optimal or non-optimal time of day. Given the presumed differences in the cognitive processes involved in solving these two types of problems, it was expected that the reduced inhibitory control associated with non-optimal times of the day would differentially impact performance on the two types of problems. In accordance with this expectation, results showed consistently greater insight problem solving performance (...) during non-optimal times of day compared to optimal times of day but no consistent time of day effects on analytic problem solving. The findings indicate that tasks involving creativity might benefit from a non-optimal time of day. (shrink)

In Time, Existential Presence and the Cinematic Image, Sam B. Girgus relates Laura Mulvey's theory of 'delayed cinema' to ideas on time and the relationship to the other in the writings of Jean-Luc Nancy, Emmanuel Levinas and Julia Kristeva, among others. The sustained tension in film between, in Mulvey's phrase, 'stillness and the moving image' enacts a drama of existential emergence. The stillness of the framed image in relation to the moving image opens 'free' cinematic time and space for a (...) fresh engagement with crucial ethical and cultural issues. With close readings of films such as The Bicycle Thieves, Two Days, One Night, The Three Burials of Melquiades Estrada, The Revenant and The Age of Innocence, this book proposes a fresh approach to reading film in the context of emerging existential presence and the ethical imperative. (shrink)

In 1956 W. B. Gallie advanced the thesis that certain political concepts, such as that of social justice, are .1 Since then, a considerable literature on the subject has developed, some of it in support of the thesis, some of it in opposition to it.2 W. E. Connolly is a leading supporter of it, and John Gray is a leading opponent of it. However, Connolly's advocacy of it in the second edition of his book is significantly more moderate than that (...) in the first (1974) edition of it. (shrink)

Induced by intake of the psychedelic substances LSD, psilocybin, DMT and mescaline, psychedelic experiences have been extensively described by subjects as entailing a most unusual increase in the scope and quality of their consciousness. Accordingly, psychedelic experiences have been widely characterised as an “expansion of consciousness.” This article poses the following question, as yet unaddressed in contemporary philosophy and the tradition of phenomenology: to what exactly does “expansion of consciousness” refer as a general characterisation of psychedelic experiences, and what role (...) might attention play therein? On the basis of Aron Gurwitsch’s phenomenology of attention, the following thesis is presented: (a) “expansion of consciousness” refers to a particular restructuration of consciousness in psychedelic experiences. (b) This occurs by means of certain extreme transformations in direction, scope, mode and degree of attention. In order to explicate this thesis, the characteristic features of psychedelic experiences that pertain to expansion of consciousness and attention are first systematically identified from a survey of subject reports. Second, it is demonstrated that the few previous attempts to understand expansion of consciousness in terms of attention as a filter/reducing-valve, spotlight or zoom-lens each fail to explain how consciousness is structured in psychedelic experiences. Third, it is argued that psychedelic expansion of consciousness is a general restructuration of consciousness by means of extreme attentional transformations. In conclusion, brief consideration is given to the question of whether psychedelic expansion of consciousness can have epistemic and ethical value for life. (shrink)

Martin B. Peterson argues that the social experiment analysis improperly shifts our focus onto the rhetorical dimension of debates over technology, which is ‘clearly irrelevant’ to the ‘traditional...

Over the last two decades the practice of applied philosophy has undergone re­surgence. It is now common for philosophers to sit on ethics committees in hospitals, or to provide ethical advice to businesses, and many universities and colleges now offer courses in practical philosophy. Despite this, practical philosophy is subject to increasing criticism, with persons charging that (1) it is philosophically shallow, and (2) it has little to offer persons grappling with concrete ethical problems, either because (a) its techniques or (...) too removed from such problems, or (b) because ethical theory is too abstract. In this paper I develop responses to these criticisms, and offer suggestions as to how practical philosophy should be developed. (shrink)

Pioneering biblical critic, theorist of democracy, and legendary conflater of God and nature, Jewish philosopher Baruch Spinoza (1632-1677) was excommunicated by the Sephardic Jews of Amsterdam in 1656 for his "horrible heresies" and "monstrous deeds." Yet, over the past three centuries, Spinoza's rupture with traditional Jewish beliefs and practices has elevated him to a prominent place in genealogies of Jewish modernity. The First Modern Jew provides a riveting look at how Spinoza went from being one of Judaism's most notorious outcasts (...) to one of its most celebrated, if still highly controversial, cultural icons, and a powerful and protean symbol of the first modern secular Jew. Ranging from Amsterdam to Palestine and back again to Europe, the book chronicles Spinoza's posthumous odyssey from marginalized heretic to hero, the exemplar of a whole host of Jewish identities, including cosmopolitan, nationalist, reformist, and rejectionist. Daniel Schwartz shows that in fashioning Spinoza into "the first modern Jew," generations of Jewish intellectuals -German liberals, East European maskilim, secular Zionists, and Yiddishists- have projected their own dilemmas of identity onto him, reshaping the Amsterdam thinker in their own image. The many afterlives of Spinoza are a kind of looking glass into the struggles of Jewish writers over where to draw the boundaries of Jewishness and whether a secular Jewish identity is indeed possible. Cumulatively, these afterlives offer a kaleidoscopic view of modern Jewish culture and a vivid history of an obsession with Spinoza that continues to this day."--Jacket. (shrink)

Clarence B. Day was an Eastern Studies philosopher and historian who published widely on China and its traditions. In addition to The Philosophers of China, Day is known for his research on Chinese theology and cults.

In 2035 global egg demand will have risen 50% from 1985. Because we are not able to tell in the egg whether it will become a male or female chick, billons of one day-old male chicks will be killed. International research initiatives are underway in this area, and governments encourage the development of an alternative with the goal of eliminating the culling of day-old male chicks. The Netherlands holds an exceptional position in the European egg trade, but is also the (...) only country in the European Union where the downside of the egg sector, the practice of killing day-old male chicks, is a recurrent subject of societal debate. ‘Preventing the killing of young animals’ and ‘in ovo sex determination’ are the two alternative approaches available to solve this problem. It is clear that both approaches solve the problem of killing day-old male chicks, either by keeping them alive or by preventing them from living, but they also raise a lot of new animal welfare-related dilemmas. A thorough analysis was undertaken of these dilemmas and the results are presented in this article. The analysis resulted in an ethical framework based on the two main approaches in bioethics: a consequentialist approach and a deontological approach. This ethical framework was used to develop an online survey administered to ascertain Dutch public opinion about these alternative approaches. The results show that neither alternative will be fully accepted, or accepted by more than half of Dutch society. However, the survey does provide an insight into the motives that are important for people’s choice: food safety and a good treatment of animals. Irrespective of the approach chosen, these values should be safeguarded and communicated clearly. (shrink)

Ethics of Everyday Medicine: Explorations of Justice examines and analyses the relatively unexplored domain of ethics involved in the everyday practice of medicine. From the author's clinical experience, virtually every decision made in the day-to-day practice of medicine is fundamentally an ethical question, as virtually every decision hinge on some value judgment that goes beyond the medical facts of the matter. The first part of the book is devoted to medical decision cases in several areas of medicine. These cases highlight (...) elements of the current healthcare ecosystem, involving players other than the physician and patient. Insurers (private, commercial, and governmental), administrators, and regulators' perspectives are surfaced in point of care case analysis. Part two contributes to the development of actionable tools to develop better ethical systems for the everyday practice of medicine by providing a critical analysis of Reflective Equilibrium and ethical induction from the perspective of logic and statistics. The chapter on Justice discusses the neurophysiological representations of just and unjust behaviours. The chapter on Ethical Theories follows, describing the epistemic conundrum, principlism, reproducibility, abstraction, chaos and complexity. The following chapter approaches ethical decisions from the logic and statistic perspectives. The following chapter, The Patient as Parenthetical, the author discusses patient-centric ethics, and the rise of business- and government-cetric ethics. The final chapter, A Framework to Frame the Questions for Explore Further, proposes a working framework to deal with current ethical issues. (shrink)

Stoicism, a philosophy and set of practices developed in ancient times, commands ever-growing interest. Its present day, students, practitioners, teachers, and scholars adapt it to the challenges of modern life. This third volume brings together fifty pieces previously published in the Stoicism Today blog, ranging from personal essays to conference presentations, from bits of practical advice to history and interpretation, from polemics to symposia grappling with controversies, key issues, and central concepts. There is something for everyone in this volume. The (...) selections in this volume range over a vast array of topics. You will encounter authors applying Stoicism to parenting, medicine, psychotherapy, culinary arts, time-management, exercise and fitness, the emotions, relationships, the workplace, and the environment. Some selections examine useful practices, the nature and scope of the virtues, how to develop equanimity, resilience, and happiness. Comparative studies bring Stoicism into connection with Buddhism, mindfulness, self-help and productivity authors, and modalities of psychotherapy. This book bridges the gaps between philosophical reflection and practical wisdom, between study and interpretation of Stoicism, and its application to present-day issues and problems. The essays in this volume speak to anyone intending to start or to deepen a thoughtful Stoic life in the modern world. (shrink)

This chapter contains sections titled: What Is Historiographic Evidence? Bayesianism Bayesianism as a Model of Historiographic Reasoning Explanationism Towards an Explanationist Bayesianism Applications: Skepticism Applications: Underdetermination References Further Reading.

In this paper we describe the objectives of teaching medical ethics to undergraduates and the teaching methods used. We describe a workshop used in the University of Liverpool Department of Psychiatry, designed to enhance ethical sensitivity in psychiatry. The workshop reviews significant historical and current errors in the ethical practice of psychiatry and doctors' defence mechanisms against accepting responsibility for deficiencies in ethical practice. The workshop explores the student doctors' own group ethos in response to ethical dilemmas, and demonstrates how (...) the individual contributes to and is responsible for the group ethos through participation and also through nonparticipation. The student feedback about the workshop is reviewed. The Toronto Ethical Sensitivity Instrument was used to assess whether or not the workshop altered sensitivity. Compared to a control group the attenders' sensitivity was significantly increased (on Student's t-test p equals or is less than 0.002). (shrink)

Whitehead had a place for God in his comprehensive cosmological vision, and his theism has long attracted interest from some Christian theologians. But Whitehead's ideas have much wider use. Some Buddhists have found help in articulating their nontheistic vision and relating it to the current world of thought and action. In this book religious writers in seven different traditions articulate how they can benefit from Whitehead's work. So this volume demonstrates that various features of his thought can contribute to many (...) communities. According to his followers, Whitehead shows that the deepest convictions and commitments of the major religious communities can be complementary rather than in conflict. Readers of this book will see how that plays out in some detail. A Whiteheadian Hindu can recognize the truth in a Whiteheadian Judaism, and both can appreciate the insights of Chinese Whiteheadians committed to their classical thinking. Perhaps a new day in interreligious understanding has come. (shrink)