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)

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.

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)

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)

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.

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 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)

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)

The need to make young scientists aware of their social responsibilities is widely acknowledged, although the question of how to actually do it has so far gained limited attention. A 2-day workshop entitled “Prepared for social responsibility?” attended by doctoral students from multiple disciplines in climate science, was targeted at the perceived needs of the participants and employed a format that took them through three stages of ethics education: sensitization, information and empowerment. The workshop aimed at preparing doctoral students to (...) manage ethical dilemmas that emerge when climate science meets the public sphere (e.g., to identify and balance legitimate perspectives on particular types of geo-engineering), and is an example of how to include social responsibility in doctoral education. The paper describes the workshop from the three different perspectives of the authors: the course teacher, the head of the graduate school, and a graduate student. The elements that contributed to the success of the workshop, and thus make it an example to follow, are (1) the involvement of participating students, (2) the introduction of external expertise and role models in climate science, and (3) a workshop design that focused on ethical analyses of examples from the climate sciences. (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)

Little is in print on the development in Britain of university disciplines including the academic study of education. This paper provides a historical narrative of the study of adolescence from the 1870 Education Act to the contemporary day. Adolescence textbooks are examined in the context of changes in the education system, such as the demand for secondary education and the expansion of teacher education. Changing emphases in adolescence research are traced through various publications to illustrate curriculum developments. The important contributions (...) of Dame Olive Wheeler, Professor W. D. Wall and other leading writers on adolescence are evaluated. It is clear that in over a century of national educational provision British teachers have never faced a great choice of adolescence texts and the paper concludes with some reflections on this observation. (shrink)

Clinical ethical support services (CESS) represent a multifaceted field of aims, consultancy models, and methodologies. Nevertheless, the overall aim of CESS can be summed up as contributing to healthcare of high ethical standards by improving ethically competent decision-making in clinical healthcare. In order to support clinical care adequately, CESS must pay systematic attention to all real-life ethical issues, including those which do not fall within the ‘favourite’ ethical issues of the day. In this paper we attempt to capture a comprehensive (...) overview of categories of ethical tensions in clinical care. We present an analytical exposition of ethical structural features in judgement-based clinical care predicated on the assumption of the moral equality of human beings and the assessment of where healthcare contexts pose a challenge to achieving moral equality. The account and the emerging overview is worked out so that it can be easily contextualized with regards to national healthcare systems and specific branches of healthcare, as well as local healthcare institutions. By considering how the account and the overview can be applied to i) improve the ethical competence of healthcare personnel and consultants by broadening their sensitivity to ethical tensions, ii) identify neglected areas for ethical research, and iii) clarify the ethical responsibility of healthcare institutions' leadership, as well as specifying required institutionalized administration, we conclude that the proposed account should be considered useful for CESS. (shrink)

The destruction of the Egyptian army in the Book of Exodus is the primary story of salvation for Israel; God is the chief combatant in this story. "Yahweh is a warrior!" So goes the victory hymn in Exodus 15:3 after the annihilation of the enemy by Yahweh, marking the importance held by this show of divine power. This unleashing of divine power and its militaristic imagery has long caught the attention of scholars as starkly nationalistic. Thomas B. Dozeman furthers this (...) study by addressing the theological problem of divine power in the Exodus story and, by extension, the Judeo-Christian attempt to deify nationalism by calling its wars holy. He interprets Exodus as liturgy, the Day of Yahweh, celebrating God's defeat of Pharaoh and the ultimate ascendancy of Israelite authority. This liturgy, though, did not remain static, but changed as the national experience of exile changed the practice of Israelite worship. An isolated event evolved into an extended account of salvation history, in which the life of faith becomes a wilderness march to the promised land. Dozeman traces how revisionary embellishments in the plot structure and characters of the Exodus story reflected the new understanding of divine power. By combining literary and historical interpretation this study offers the first serious inquiry into the idea of divine power, and makes a major contribution to resurgent research on the Pentateuch as a whole. No scholar concerned with biblical historiography and its justification of holy wars can afford to ignore this book. (shrink)

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)