BackgroundThe U.S. Food and Drug Administration traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, we convened (...) a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.ResultsThe team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.FundingThe development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation. (shrink)

An unpublished satirical work, writtenc.1848–1854, provides fresh insight into the most famous scientific voyage of the nineteenth century. John Clunies Ross, settler of Cocos-Keeling – which HMSBeaglevisited in April 1836 – felt that Robert FitzRoy and Charles Darwin had ‘depreciated’ the atoll on which he and his family had settled a decade earlier. Producing a mock ‘supplement’ to a new edition of FitzRoy'sNarrative, Ross criticized their science and their casual appropriation of local knowledge. Ross's virtually unknown (...) work is intriguing not only for its glimpse of theBeaglevoyage, but also as a self-portrait of an imperial scientific reader. An experienced merchant seaman and trader–entrepreneur with decades of experience in the region, Ross had a very different perspective from that of FitzRoy or Darwin. Yet he shared many of their assumptions about the importance of natural knowledge, embracing it as part of his own imperial projects. Showing the global reach of print culture, he used editing and revision as satirical weapons, insisting on his right to participate as both reader and author in scientific debate. (shrink)

Julie Childers and Bob Arnold’s (2019) article, “The Inner Lives of Doctors: Physician Emotion in the Care of the Seriously Ill,” uses Kübler-Ross’s influential work on death and dying to remind us...

Adam Smith was baptized on 5 June 1723 in the Fife seaport of Kirkcaldy, where his father, who died on 9 January 1723, had served as Comptroller of Customs. Father Adam Smith studied the liberal arts in Aberdeen, took legal training in Edinburgh qualifying him for estate management, and became secretary to a Campbell magnate. He hesitated about taking up a Customs post in Kirkcaldy, because his income there depended on volume of trade, which was falling off. However, he handled (...) his money well, and married the daughter of a substantial Fife laird. His Will specified that his widow, Margaret Douglas, would get help in raising young Adam from guardians associated with intellectual and economic improvement in Scotland. (shrink)

The paper begins by providing a game-theoretic reconstruction of Gilbert’s (1989) philosophical critique of Lewis (1969) on the role of salience in selecting conventions. Gilbert’s insight is reformulated thus: Nash equilibrium is insufficiently powerful as a solution concept to rationalize conventions for unboundedly rational agents if conventions are solutions to the kinds of games Lewis supposes. Both refinements to NE and appeals to bounded rationality can plug this gap, but lack generality. As Binmore (this issue) argues, evolutive game theory readily (...) explains the origin of conventional behavior, but that is not Lewis’s project. Gilbert’s critique is generalized by reference to Bacharach’s (2006) work on team reasoning in games. The paper then argues that although Lewis’s account of the rationalization of conventions is shown by the reconstruction of Gilbert’s critique to be incomplete, Gilbert is wrong to conclude that classical (‘eductive’) game theory lacks the resources to explain conformity to conventions among people. A game-theoretic account of the dynamics of socialization, based on Ross’s (2005, 2006) idea of ‘game determination’, rationalizes choices of conventional strategies in overlapping generations contexts, provided agents are products of evolutionary selection and know that other players are also such products. (shrink)

The emotional strength of his mother, Margaret Douglas, and close kinship bonds, to some degree, compensated Adam Smith for the loss of his father. In addition, he was well prepared at the Kirkcaldy burgh school for his student years, and found his vocation as a moral philosopher, in an era marked by a strong drive for advance in agriculture and other economic sectors. Most important of all, his Presbyterian inheritance, together with training in the Latin and Greek classics, instilled (...) in him the values of self‐command of a Stoic cast, frugality, diligence in his calling, and strict justice towards others tempered with benevolence, which characterized his actions and his teaching. At the same time, he seemed to have developed an independence of mind, which led him to rebel against the strict controls of Calvinism meant to check human depravity, and to set store by human goodness, and the will to enjoy natural liberty. (shrink)

Moral Repair examines the ethics and moral psychology of responses to wrongdoing. Explaining the emotional bonds and normative expectations that keep human beings responsive to moral standards and responsible to each other, Margaret Urban Walker uses realistic examples of both personal betrayal and political violence to analyze how moral bonds are damaged by serious wrongs and what must be done to repair the damage. Focusing on victims of wrong, their right to validation, and their sense of justice, Walker presents (...) a unified and detailed philosophical account of hope, trust, resentment, forgiveness, and making amends - the emotions and practices that sustain moral relations. Moral Repair joins a multidisciplinary literature concerned with transitional and restorative justice, reparations, and restoring individual dignity and mutual trust in the wake of serious wrongs. (shrink)

Humanity and the very notion of the human subject are under threat from postmodernist thinking which has declared not only the 'Death of God' but also the 'Death of Man'. This book is a revindication of the concept of humanity, rejecting contemporary social theory that seeks to diminish human properties and powers. Archer argues that being human depends on an interaction with the real world in which practice takes primacy over language in the emergence of human self-consciousness, thought, emotionality and (...) personal identity - all of which are prior to, and more basic than, our acquisition of a social identity. This original and provocative new book from leading social theorist Margaret S. Archer builds on the themes explored in her previous books Culture and Agency (CUP 1988) and Realist Social Theory (CUP 1995). It will be required reading for academics and students of social theory, cultural theory, political theory, philosophy and theology. (shrink)

I argue that the truthmaker theorist should be a priority monist if she wants to avoid commitment to mysterious necessary connections. In section 1 I briefly discuss the ontological options available to the truthmaker theorist. In section 2 I develop the argument against truthmaker theory from the Humean denial of necessary connections. In section 3 I offer an account of when necessary connections are objectionable. In section 4 I use this criterion to narrow down the options from section 1. In (...) section 5 I argue that the account leads us to priority monism. (shrink)

Works of music do not appear to be concrete objects; but they do appear to be created by composers, and abstract objects do not seem to be the kind of things that can be created. In this paper I aim to develop an ontological position that lets us salvage the creativity intuition without either adopting an ontology of created abstracta or identifying musical works with concreta. I will argue that there are no musical works in our ontology, but nevertheless the (...) English sentences we want to hold true are literally true. I rely on a meta-ontological view whereby ‘a exists’ can be true without committing us to an entity that is a. This meta-ontological view is illustrated by its application to the familiar example of the statue and the clay. I argue that my account of musical ontology fares better on the balance of costs and benefits than its rivals. (shrink)

Nation and Identity provides a concise and comprehensive account of the place of national identity in modern life. Ross Poole argues that the nation became a fundamental organising principle of social, political and moral life during the period of early modernity and that is has provided the organising principle of much liberal, republican and democratic thought. Ross Poole offers us a new and urgently needed analysis of the concept of identity, arguing that we are now in a position (...) to envisage the end of nationalism. We see that the impact of issues like multiculturalism, republicanism, and indigenous rights have made it very difficult to see how the possibility of a postnational cosmopolitanism could not degenerate into a nihilistic moral universe. Nation and Identity will be a fascinating read for all those interested in issues of national identity, both politically and philosophically. (shrink)

There is increasing public interest in understanding the nature of corporate ethics due to the knowledge that unethical decisions and activities frequently undermine the performance and abilities of many organizations. Of the current literature found on the topic of ways organizations can influence ethical behavior, a majority is found on the issue of corporate codes of ethics.Most discussions on codes of ethics evaluate the contents of the codes and offer opinions on their wording, content, and/or value. Unfortunately, very little research (...) has been devoted towards discovering whether they are effective in promoting ethical decision-making behavior. Thus, due to the lack of empirical research on this particular topic, this paper attempts to further address this issue. (shrink)

Together, these entail that for every true proposition p, there exists some thing which could not exist and p be false.

If particularism is right, the broad moral claims we make are usually riddled with exceptions. But such generalizations can still be a useful, even necessary part of moral life. They help us show what we should do, and they are essential for understanding why we should do it.

The past twenty years have witnessed the consolidation of deliberation as the normative basis of democratic theory. Although different versions of deliberative democracy vary in scope and degree of institutionalization, they share the assumption that the rational consensus engendered through discussion should serve as the normative guide for democratic politics. Although this tradition has roots in the birth of bourgeois liberal thought, it has received renewed attention due to Habermas’s reformulation on the basis of discourse ethics. In his middle period, (...) Habermas had attempted to ground rationality in the structure of discourse itself, in the ideal preconditions of intersubjective communication.1 His more pragmatist heirs, however, jettison transcendental truth claims while maintaining that deliberation can enhance the legitimacy of consensual solutions to the moral dilemmas which divide citizens. (shrink)

Moral virtue is, for Aristotle, a state to which an agent’s motivation is central. For anyone interested in Aristotle’s account of moral development this invites reflection on two questions: how is it that virtuous motivational dispositions are established? And what contribution do the moral learner’s existing motivational states make to the success of her habituation? I argue that views which demand that the learner act with virtuous motives if she is to acquire virtuous dispositions misconstrue the nature and structure of (...) the habituation process, but also obscure Aristotle’s crucial insight that the very practice of virtuous actions affords a certain discovery and can be transformative of an agent’s motivational states. Drawing attention, in Aristotle’s account, to an asymmetry between the agential perspective and the observation of others, I consider what the agential perspective affords the learner, and offer a novel interpretation of the role a learner’s existing motives play in her habituation. (shrink)

Businesses that produce bioscience products—gene tests and therapies, pharmaceuticals, vaccines, and medical devices—are regularly confronted with ethical issues concerning these technologies. Conflicts exist between those who support advancements in bioscience and those who fear the consequences of unfettered scientific license. As the debate surrounding bioscience grows, it will be increasingly important for business managers to consider the larger consequences of their work. This groundbreaking book follows industry research, development, and marketing of medical and bioscience products across a variety of fields, (...) including biotechnology, pharmaceuticals, and bio-agriculture. Compelling and current case studies highlight the ethical decisions business managers frequently face. With the increasing visibility and public expectation placed on businesses in this sector, managers need to understand the ethical and social issues. This book addresses that need and provides a framework for incorporating ethical analysis in business decision making. (shrink)

"Most modern legal theorists seek to limit their enquiries to a particular sort of law, on the assumption that law is necessarily restricted in its interactions with other social practices. margaret Davies deliberately - and provocatively - questions the usefulness of such 'positivist' dogmas, asserting that the law can and should be seen as multi-dimensional. Davies argues that the law is everywhere - in metaphysics, the social environment, language and the psyche. In a persuasive meeting of postmodern discourse, deconstruction, (...) feminism and legal theory, Davies creates new ways of thinking about the law by creating links with other practices and disciplines where none previously existed. This is a powerful critique of the ideology and theory of law in the West, providing a much-needed link between conventional legal philosophy and modern movements in legal theory." --From back cover. (shrink)

This article explains how 19th-century radical republicans answered the following question: how is it possible to be free in a social order that fosters economic dependence on others? I focus on the writings of a group of French thinkers called the solidarists who advocated “liberty organized for everyone.” Mutualism and social right were two components of the solidarist strategy for limiting domination in commercial/industrial society. While the doctrine of mutualism was rooted in pre-industrial artisan culture, social right was a novel (...) idea that built on Durkheim’s analysis of the division of labour. In this article, I describe the main features of the solidarist account: solidarity, social property, quasi-contractual debt, and restorative justice. Classical republicanism was deeply concerned with citizen participation and the balance between popular and elite power, but 19th-century radical republicans thought that these goals must be approached differently in market societies in which enormous power is exercised outside the state. The solidarists cautiously embraced the state as a mechanism for regulating the market in order to ensure equal liberty. Social right and mutualism were also conceived as ways of limiting the centralization of state power. (shrink)

The evolving Ebola epidemic in West Africa is unprecedented in its size and scope, requiring the rapid mobilization of resources. It is too early to determine all of the ethical challenges associated with the outbreak, but these should be monitored closely. Two issues that can be discussed are the decision to implement and evaluate unregistered agents to determine therapeutic or prophylactic safety and efficacy and the justification behind this decision. In this paper, I argue that it is not compassionate use (...) that justifies this decision and suggest three lines of reasoning to support the decision. (shrink)

When a woman is pregnant, how should we understand the moral status of the life within her? How should we understand its status as conceptus, as embryo, when an early or again matured fetus? According to some, human life in all of these forms is inviolable: early human life has a moral status equivalent to a person from the moment of conception. According to others, such life has no intrinsic status, even late in pregnancy. According to still others, moral status (...) emerges when sentience does. Until the fetus is conscious - a point somewhere at the end of the second trimester, it has no moral status at all; after it is conscious, it does. (shrink)

In this paper, I urge that the very real lessons Carol Gilligan's work in moral psychology offer to moral philosophy can best be appreciated if we take seriously the gap between the two disciplines. The care and justice perspectives Gilligan explores are psychological orientations, and orientations are defined as much by matters of emphasis, selectivity of interpretation, and gestalt as they are by propositional commitment. As such, I argue, their contribution to moral theory is best seen as stances from which (...) to do theory, rather than as constituting ready-made theories themselves. In pursuing this train of thought, I examine how Gilligan's work has developed over time and how, in the end, we should understand the juxtaposition between the two orientations. (shrink)

Tomasello argues in the target article that a sense of moral obligation emerges from the creation of a collaborative “we” motivating us to fulfill our cooperative duties. We suggest that “we” takes many forms, entailing different obligations, depending on the type of the relationship in question. We sketch a framework of such types, functions, and obligations to guide future research in our commentary.