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)

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.

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.

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)

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 this article, I develop the point that whereas talent is the basis for desert, talent itself is not meritocratically deserved. It is produced by three processes, none of which are meritocratic: talent is unequally distributed by the rigged lottery of birth, talent is defined in ways that favor some traits over others, and the market for talent is manipulated to maximally extract advantages by those who have more of it. To see how, we require a sociological perspective on economic (...) rent. I argue that talent is a major means through which people seek rent in modern-day capitalism. Talent today is what inherited land was to feudal societies; an unchallenged source of symbolic and economic rewards. Whereas God sanctified the aristocracy’s wealth, contemporary privilege is legitimated by meritocracy. Drawing on the work of Gary Becker, Pierre Bourdieu, and Jerome Karabel, I show how rent-seeking in modern societies has come to rely principally on rent-definition and creation. Inequality is produced by the ways in which talent is defined, institutionalized, and sustained by the moral deservingness we attribute to the accomplishments of talents. Consequently, today’s inequalities are as striking as ever, yet harder to challenge than ever before. (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)

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)

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)

A mammoth survey of contemporary psychological research. The subjects treated range from psychotherapy to psychometrics, and from neurology to military psychology. Most of the chapters include both a scholarly background and an introductory statement of the developments and the problems of the subject, and each is followed by a bibliography. The variation which is inevitable in such an undertaking is itself informative of differences in contemporary psychology.--R. B.