The FDA's new table of surrogate endpoints used for drug approvals is an important step forward for overseeing the use of biomarkers in clinical trials. Nevertheless, we present several ways in which the table can be improved.

The Covid‐19 pandemic highlighted the need to examine public trust in the U.S. Food and Drug Administration (FDA) vaccine approval process and the role of political influence in the FDA's decisions. Ensuring that the FDA is itself trustworthy is important for justifying public trust in its actions, like vaccine approvals, thereby promoting public health. We propose five conditions of trustworthiness that the FDA should meet when it reviews vaccines, even during emergencies: consistency with rules, proper expert or political decision‐makers, proper (...) decision‐making and noninterference, connection to public preference, and transparency of both reasons and procedures. The five conditions provide a road map of procedural and substantive requirements, which the FDA has variably implemented, focused on ensuring appropriate influence of political interests. While being a trustworthy agency cannot guarantee the public's trust, implementing these conditions builds a groundwork for public trust. (shrink)

The authors respond to a letter by Mitchell Berger in the March‐April 2024 issue of the Hastings Center Report concerning their essay “Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines.”.

In this article I defend innocuousism– a weak form of Epicureanism about the putative badness of death. I argue that if we assume both mental statism about wellbeing and that death is an experiential blank, it follows that death is not bad for the one who dies. I defend innocuousism against the deprivation account of the badness of death. I argue that something is extrinsically bad if and only if it leads to states that are intrinsically bad. On my view, (...) sometimes dying may be less good than living, but it is never bad to die. (shrink)

How do we know right from wrong? Do we even have moral knowledge? Moral epistemology studies these and related questions about our understanding of virtue and vice. It is one of philosophy’s perennial problems, reaching back to Plato, Aristotle, Aquinas, Locke, Hume and Kant, and has recently been the subject of intense debate as a result of findings in developmental and social psychology. Throughout the book Zimmerman argues that our belief in moral knowledge can survive sceptical challenges. He also draws (...) on a rich range of examples from Plato’s Meno and Dickens’ David Copperfield to Bernard Madoff and Saddam Hussein. (shrink)

There is a tension in Emilie Du Châtelet’s thought on mathematics. The objects of mathematics are ideal or fictional entities; nevertheless, mathematics is presented as indispensable for an account of the physical world. After outlining Du Châtelet’s position, and showing how she departs from Christian Wolff’s pessimism about Newtonian mathematical physics, I show that the tension in her position is only apparent. Du Châtelet has a worked-out defense of the explanatory and epistemic need for mathematical objects, consistent with their metaphysical (...) nonfundamentality. I conclude by sketching how Du Châtelet’s conception of mathematical indispensability differs interestingly from many contemporary approaches. (shrink)

Merold Westphal's book is a wonderful introduction to the history of philosophy.

It is widely held that, in his pre-Critical works, Kant endorsed a necessitation account of laws of nature, where laws are grounded in essences or causal powers. Against this, I argue that the early Kant endorsed the priority of laws in explaining and unifying the natural world, as well as their irreducible role in in grounding natural necessity. Laws are a key constituent of Kant’s explanatory naturalism, rather than undermining it. By laying out neglected distinctions Kant draws among types of (...) natural law, grounding relations, and ontological levels, I show that his early works present a coherent and sophisticated laws-first account of the natural order. (shrink)

A new theory of how the brain constructs emotions that could revolutionize psychology, health care, law enforcement, and our understanding of the human mind Emotions feel automatic, like uncontrollable reactions to things we think and experience. Scientists have long supported this assumption by claiming that emotions are hardwired in the body or the brain. Today, however, the science of emotion is in the midst of a revolution on par with the discovery of relativity in physics and natural selection in biology--and (...) this paradigm shift has far-reaching implications for us all. Leading the charge is psychologist and neuroscientist Lisa Feldman Barrett, whose theory of emotion is driving a deeper understanding of the mind and brain, and shedding new light on what it means to be human. Her research overturns the widely held belief that emotions are housed in different parts of the brain and are universally expressed and recognized. Instead, she has shown that emotion is constructed in the moment, by core systems that interact across the whole brain, aided by a lifetime of learning. This new theory means that you play a much greater role in your emotional life than you ever thought. Its repercussions are already shaking the foundations not only of psychology but also of medicine, the legal system, child-rearing, meditation, and even airport security. Why do emotions feel automatic? Does rational thought really control emotion? How does emotion affect disease? How can you make your children more emotionally intelligent? How Emotions Are Made answers these questions and many more, revealing the latest research and intriguing practical applications of the new science of emotion, mind, and brain. (shrink)

Among the important themes in Roderick Chisholm's epistemology are his commitment to internalism, his defense of the independence of epistemology from empirical science, and his assumption that we do know most of what we initially think we know. In “Roderick Chisholm and the Shaping of American Epistemology” Hilary Kornblith argues that Chisholm's views lead to a radical divorce between the factors that justify beliefs and the factors that cause beliefs, that Chisholm's views have the consequence that there is no connection (...) between justification and truth, and that Chisholm's kind of epistemology is unable to give epistemic advice. I argue that Chisholm's views do not have these consequences. (shrink)

By contributing a few hundred dollars to a charity like UNICEF, a prosperous person can ensure that fewer poor children die, and that more will live reasonably long, worthwhile lives. Even when knowing this, however, most people send nothing, and almost all of the rest send little. What is the moral status of this behavior? To such common cases of letting die, our untutored response is that, while it is not very good, neither is the conduct wrong. What is the (...) source of this lenient assessment? In this contentious new book, one of our leading philosophers argues that our intuitions about ethical cases are generated not by basic moral values, but by certain distracting psychological dispositions that all too often prevent us from reacting in accord with our commitments. Through a detailed look at how these tendencies operate, Unger shows that, on the good morality that we already accept, the fatally unhelpful behavior is monstrously wrong. By uncovering the eminently sensible ethics that we've already embraced fully, and by confronting us with empirical facts and with easily followed instructions for lessening serious suffering appropriately and effectively, Unger's book points the way to a compassionate new moral philosophy. (shrink)

We argue that the value of authenticity does not explain the value of self-knowledge. There are a plurality of species of authenticity; in this paper we consider four species: avoiding pretense (section 2), Frankfurtian wholeheartedness (section 3), existential self-knowledge (section 4), and spontaneity (section 5). Our thesis is that, for each of these species, the value of (that species of) authenticity does not (partially) explain the value of self-knowledge. Moreover, when it comes to spontaneity, the value of (that species of) (...) authenticity conflicts with the value of self-knowledge. (shrink)

It is now medically possible for a baby to have two biological mothers. A fertilized ovum from one woman can be implanted into a second woman for gestation in her uterus. In fact, there have been several such cases. The ova donor is the mother in the genetic sense: her genetic material,along with that of the sperm donor,appears in the developing baby. The uterine hostess is the birth mother: she gestates the fetus and gives birth to it. In essence, the (...) two female reproductive functions, genetic and gestational, can be and have been divided from each other. Our current conception of biological maternity has lagged behind these technological marvels and still assumes that both functions will be performed by the same woman. At a time when two "biological mothers" can and do make claims for the same child,each on the ground that she is the "true mother", it is crucial to examine our concepts of biological maternity and their relation to our social policies about maternity in these cases. In this paper I will argue that the best social and legal policy would involve a prima facie preference for the claims of the gestational mother over the claims of the genetic mother for custody of the child in a contest (if there is no question of parental unfitness on either side). That is, in any dispute, presumption should be in favor of the gestational mother. This argument is made independent of considerations about pre-birth and pre-conception contracts, because the issues raised about the roles of gestational and genetic maternity are substantial in themselves and have obvious implications about the acceptability of such contracts.Rather, I argue that a revision of our concept of biological maternity which emphasizes the importance of gestation and which would prefer the claims of the gestational over the genetic mother would have positive benefits for both women and newborns. (shrink)

Research regulations around the world do not impose any limits on the risks to which consenting adults may be exposed. Nonetheless, most review committees regard some risks as too high, even for consenting adults. To justify this practice, commentators have appealed to a range of considerations which are external to informed consent and the risks themselves. Most prominently, some argue that exposing consenting adults to very high risks has the potential to undermine public trust in research. This justification assumes that (...) it is not the magnitude of the risks themselves which raises concern, but the way in which the public might respond to them. This justification thus depends on the possibility that the public will find out about the risks and respond to them in the specified way. Like the other proposed external justifications, it thereby fails to offer a reason to think that exposing consenting adults to very high risks is problematic in itself. In the present paper, we describe and endorse a different justification. Rather than appealing to external factors, we argue that limits on risks for consenting adults trace to internal limits on informed consent, to limits on the things consent can and cannot make ethically permissible. In doing so, we aim to provide a firmer conceptual basis for the view that some research risks are unacceptably high, no matter how the research is conducted. (shrink)

Philosophers, accounted wise in their generation and even beyond their generation, have enthroned the unchanging and sung the praises of fatality and acquiescence. But there is a voice even more authoritative than that of the sages—the voice of the LifeShaper himself. Perched on the height of the human soul, he has set two watchmen, more sagacious and knowing than the Metaphysicians who weave words “About it and about” in the taverns beneath; their names are Wonder and Surprise. Wonder spies out (...) novelty, and Surprise discerns change. Wonder arises at that which is beyond expectation; Surprise at that which is contrary to expec tation. What could completely surpass expectation save the completely novel? What could so drastically dismantle expectation save the hurricane onset of change? (shrink)

Polarization is a topic of intense interest among social scientists, but there is significant disagreement regarding the character of the phenomenon and little understanding of underlying mechanics. A first problem, we argue, is that polarization appears in the literature as not one concept but many. In the first part of the article, we distinguish nine phenomena that may be considered polarization, with suggestions of appropriate measures for each. In the second part of the article, we apply this analysis to evaluate (...) the types of polarization generated by the three major families of computational models proposing specific mechanisms of opinion polarization. (shrink)

Polarization is a topic of intense interest among social scientists, but there is significant disagreement regarding the character of the phenomenon and little understanding of underlying mechanics. A first problem, we argue, is that polarization appears in the literature as not one concept but many. In the first part of the article, we distinguish nine phenomena that may be considered polarization, with suggestions of appropriate measures for each. In the second part of the article, we apply this analysis to evaluate (...) the types of polarization generated by the three major families of computational models proposing specific mechanisms of opinion polarization. (shrink)

In Chapter 17 of his magnificent Reasons and Persons, Derek Parfit asks what he describes as an ‘awesome question’: ‘How many people should there ever be?’ For a utilitarian like me, the answer seems simple: there should be however many people it takes to make the world best. Unfortunately, if I answer Parfit's awesome question in this way, I may sink myself in a quagmire of axiological confusion. In this paper, I first describe certain aspects of the quagmire. Then I (...) introduce and explain some of the elements of a novel axiological view – ‘justicism’. Justicism is derived from some ideas originally suggested by Franz Brentano. It was developed in an effort to solve certain other problems confronting utilitarianism – problems explicitly about justice. I think, however, that as a sort of happy by-product, justicism also generates a plausible answer to Parfit's awesome question. This may come as a bit of surprise, since justicism is a form of totalism, and it is widely thought that no totalistic theory can provide a satisfactory answer to Parfit's question. After presenting and explaining my proposed solution, I address some objections. (shrink)

The aim of this paper is to bring recent work on metaphysical grounding to bear on the phenomenon of social construction. It is argued that grounding can be used to analyze social construction and that the grounding framework is helpful for articulating various claims and commitments of social constructionists, especially about social identities, e.g., gender and race. The paper also responds to a number of objections that have been leveled against the application of grounding to social construction from Elizabeth Barnes, (...) Mari Mikkola, and Jessica Wilson. (shrink)

Obligations to reduce one’s green house gas emissions appear to be difficult to justify prior to large-scale collective action because an individual’s emissions have virtually no impact on the environmental problem. However, I show that individuals’ emissions choices raise the question of whether or not they can be justified as fair use of what remains of a safe global emissions budget. This is true both before and after major mitigation efforts are in place. Nevertheless, it remains difficult to establish an (...) obligation to reduce personal emissions because it appears unlikely that governments will in fact maintain safe emissions budgets. The result, I claim, is that under current conditions we lack outcome, fairness, promotional, virtue or duty based grounds for seeing personal emissions reductions as morally obligatory. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Philosophy and Rhetoric 34.1 (2001) 21-37 [Access article in PDF] Conscience and the Concealments of Metaphor in Hobbes's Leviathan Karen S. Feldman Introduction Conscience is not a topic of terribly heated debate in Hobbes research. 1 Nevertheless, my claim in this article is that conscience in the Leviathan, which Hobbes poses as an example of the dangers of metaphor, is not merely an example of the dangers of (...) metaphor, but rather is the most dangerous metaphor, the metaphor that corrupts knowledge and thereby makes error and deception possible. Hobbes's brief account of conscience, which appears in the chapter of Leviathan on the ends of discourse, tells the story of the insinuation of metaphor into proper nomenclature; however, his example of the metaphorical use of the word conscience turns the story into one in which public knowledge itself is made private and thereby corrupted. Moreover, according to the story, private conscience is itself invented by means of a metaphor; it is in effect metaphorized into being. 2 With the emergence of private conscience, the potential of privatization expands from the privatization of the meaning of words to an entire private sphere of opinion. The metaphorical corruption of conscience invents a new understanding of knowledge as isolated from other witnesses, and the resultant privatization of truth lends itself to the corruption of that truth. Thus, whereas Hobbes characterizes the wrong use of names (of which metaphor is an instance) as a threat to accurate judgment and reason (L 22-23, 34, 161-62), as I will argue in the sections following, Hobbes's demand for the preservation of proper meaning in Leviathan corresponds to an anxiety regarding privacy and its peculiar potential for corrupting truth and knowledge. Hobbes's worries as to the dangers that metaphor poses to the stability of the commonwealth thereby converge with his worries about the dangers of conscience to the principle of public authority (cf. Strong 1993). [End Page 21] Hobbes's condemnations of conscience In Leviathan, conscience is condemned as a source of principles of human decision and action in a commonwealth. The problem with conscience as a principle of action is that it renders each individual inventor of his own rules and judge of his own actions. In brief, individual conscience is incommensurable with the public authority that defines a commonwealth: Another doctrine repugnant to civil society, is, that whatsoever a man does against his conscience, is sin; and it dependeth on the presumption of making himself judge of good and evil. For a man's conscience, and his judgment is the same thing, and as the judgment, so also the conscience may be erroneous. Therefore, though he that is subject to no civil law, sinneth in all he does against his conscience, because he has no other rule to follow but his own reason; yet it is not so with him that lives in a commonwealth; because the law is the public conscience, by which he hath already undertaken to be guided. Otherwise in such diversity, as there is of private consciences, which are but private opinions, the commonwealth must needs be distracted, and no man dare to obey the sovereign power, further than it shall seem good in his own eyes. (L 311) In this account, conscience is not just inferior to civil law as a principle guiding action, but at odds with civil society and the good of the commonwealth. The fact that conscience is private renders it problematic for the commonwealth for several reasons: First, as privately invented, it may be erroneous. Likewise, because it is private, conscience does not possess any binding power outside the individual, private sphere. Each person may be bound by his own conscience, but insofar as consciences differ, standards of action differ, and this leads to the undermining and distraction of the commonwealth. Likewise, private consciences may be divergent from one another, and the conflicts in private judgment produce conflicting actions that disturb the peace of the commonwealth. This rule of privacy is, moreover, associated with primitive life and with the state of nature... (shrink)

This collection of essays is the first of its kind to focus on the relationship between composition and identity. Twelve original articles--written by internationally renowned scholars and rising stars in the field--argue for and against the controversial doctrine that composition is identity.--Provided by publisher.

Within the context of service inquiries, and the specialized inferential logic associated with the particularized activities there is a gap in the orientations of customers and service representatives. Specifically, one problem that arises in customer service encounters is that customers and service representatives appear to arrive at different understandings of what constitutes a relevant response to a service inquiry. By examining one type of customer service context, calls to an electronic repair facility, this article offers a conversation analytic account of (...) how customers use formulations to collaboratively achieve a mutually agreed upon answer to their service inquiry and close the gap in the underlying logics that emerge in these calls. (shrink)

: Contemporary common sense holds that authenticity is an ethical ideal: that there is something bad about inauthenticity, and something good about authenticity. Here we criticize the view that authenticity is bad because it detracts from the wellbeing of the inauthentic person, and propose an alternative moral account of the badness of inauthenticity, based on the idea that inauthentic behaviour is potentially misleading.

One of the most profound interactions that can occur between people, apologies have the power to heal humiliations, free the mind from deep-seated guilt, remove the desire for vengeance, and ultimately restore broken relationships. With On Apology, Aaron Lazare offers an eye-opening analysis of this vital interaction, illuminating an often hidden corner of the human heart. He discusses the importance of shame, guilt, and humiliation, the initial reluctance to apologize, the simplicity of the act of apologizing, the spontaneous generosity (...) and forgiveness on the part of the offended, the transfer of power and respect between two parties, and much more. Readers will not only find a wealth of insight that they can apply to their own lives, but also a deeper understanding of national and international conflicts and how we might resolve them. The act of apologizing is quite simply immensely fulfilling. On Apology opens a window onto this common occurrence to reveal the feelings and actions at the heart of this profound interaction. (shrink)

For Émilie Du Châtelet, I argue, a central role of the principle of sufficient reason is to discriminate between better and worse explanations. Her principle of sufficient reason does not play this role for just any conceivable intellect: it specifically enables understanding for minds like ours. She develops this idea in terms of two criteria for the success of our explanations: “understanding how” and “understanding why.” These criteria can respectively be connected to the determinateness and contrastivity of explanations. The crucial (...) role Du Châtelet’s principle of sufficient reason plays in identifying good explanations is often overlooked in the literature, or else run together with questions about the justification and likelihood of explanations. An auxiliary goal of the article is to situate Du Châtelet’s principle of sufficient reason with respect to some of the general epistemological and metaphysical commitments of her Institutions de Physique, clarifying how it fits into the broader project of that work. (shrink)

Little is known about the mechanisms by which psychology graduate programs transmit responsible conduct of research (RCR) values. A national sample of 968 current students and recent graduates of mission-diverse doctoral psychology programs completed a Web-based survey on their research ethics challenges, perceptions of RCR mentoring and department climate, whether they were prepared to conduct research responsibly, and whether they believed psychology as a discipline promotes scientific integrity. Research experience, mentor RCR instruction and modeling, and department RCR policies predicted student (...) RCR preparedness. Mentor RCR instruction, department RCR policies, and faculty modeling of RCR behaviors predicted confidence in the RCR integrity of the discipline. Implications for training are discussed. (shrink)

When citizens are pulled over by police for traffic violations, they often volunteer accounts for their driving conduct. These accounts convey important character qualities about the citizen, as well as exigencies that motivate officer response. We use the method of conversation analysis to show that where a citizen positions an account in the course of an encounter is subject to different interactional-organizational constraints, which in turn afford citizens different resources for self-presentation. We also show that officers are sensitive to citizens’ (...) accounts and respond to them in differentiated ways. In addition to being a resource for self-presentation, citizens’ volunteered accounts are a resource for motivating and shaping police action. (shrink)

In a little over two hundred years, American legal thought moved from premodernism through modernism and into postmodernism. This book charts that intellectual voyage, stressing both the historical contexts in which ideas unfolded and the inherent force of the ideas themselves.Author Stephen M. Feldman first defines "premodernism," "modernism," and "postmodernism," then explains the development of American legal thought through these three intellectual periods. His narrative revolves around two broad, interrelated themes: jurisprudential foundations and the notion of progress. He points (...) out that much of American legal thought has grappled with the problem of identifying the foundations of the American judicial system and judicial decision making. The various ideas of jurisprudential foundations, moreover, are closely tied to shifting notions of progress-the definition of the term, assumptions about the possibility of progress, and hopes about how law might contribute to it.This book's broad historical sweep and its clear explanations of the competing theoretical positions of current legal scholarship make it indispensable to students and scholars of jurisprudence and American legal history. (shrink)

Timothy Williamson has argued that a person S ’s total evidence is constituted solely by propositions that S knows. This theory of evidence entails that a false belief can not be a part of S ’s evidence base for a conclusion. I argue by counterexample that this thesis (E = K for now) forces an implausible separation between what it means for a belief to be justified and rational from one’s perspective and what it means to base one’s beliefs on (...) the evidence. Furthermore, I argue that E = K entails the implausible result that there are cases in which a well-evidenced belief necessarily can not serve as evidence for a further proposition. (shrink)

The expansion of extractive corporations’ overseas business operations has led to serious concerns regarding human rights–related impacts. As theseapprehensions grow, we see a countervailing rise in calls for government intervention and in levels of socially conscious shareholder advocacy. I focus on the latter as manifested in recent use of the shareholder proposal mechanism found in corporate law. Shareholder proposals, while under-theorized, provide a valuable lens through which to consider the argument that economic behaviour is embedded within social relations. In doing (...) so, I situate my analysis within Third World Approaches to International Law (TWAIL) scholarship. Elsewhere, I have supported the use of corporate law tools in advancing the international human rights enterprise and argued that investment activism can be an essential component of this advancement. This paper represents a reflexive pause. Using the case study of a recent proposal submitted to Goldcorp Inc., I seek to problematize the shareholder proposal as a human rights advocacy tool and to examine it as a site of contestation. (shrink)

I examine the link between extensionality principles of classical mereology and the anti‐symmetry of parthood. Varzi's most recent defence of extensionality depends crucially on assuming anti‐symmetry. I examine the notions of proper parthood, weak supplementation and non‐well‐foundedness. By rejecting anti‐symmetry, the anti‐extensionalist has a unified, independently grounded response to Varzi's arguments. I give a formal construction of a non‐extensional mereology in which anti‐symmetry fails. If the notion of ‘mereological equivalence’ is made explicit, this non‐anti‐symmetric mereology recaptures all of the structure (...) of classical mereology. (shrink)

Bayesian Conditionalization is a widely used proposal for how to update one’s beliefs upon the receipt of new evidence. This is in part because of its attention to the totality of one’s evidence, which often includes facts about what one’s new evidence is and how one has come to have it. However, an increasingly popular position in epistemology holds that one may gain new evidence, construed as knowledge, without being in a position to know that one has gained this evidence. (...) These are cases of KK-Failure, cases where one knows p but is not in a position to know that one knows p. This paper assumes that certain KK-Failures are possible and argues that Conditionalization goes wrong in those cases. (shrink)

As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. Variation in IRB biobanking policies about these issues has not been well documented.

Abstract: Philosophers interested in Kant's relevance to contemporary debates over the nature of mental content—notably Robert Hanna and Lucy Allais—have argued that Kant ought to be credited with being the original proponent of the existence of ‘nonconceptual content’. However, I think the ‘nonconceptualist’ interpretations that Hanna and Allais give do not show that Kant allowed for nonconceptual content as they construe it. I argue, on the basis of an analysis of certain sections of the A and B editions of the (...) Transcendental Deduction, for a ‘conceptualist’ reading of Kant's Critique of Pure Reason. My contention is that since Kant's notion of empirical intuition makes essential reference to the categories, it must be true for him that no empirical intuition can be given in sensibility independently of the understanding and its categories. (shrink)

I reconstruct J. H. Lambert’s views on how practical grounds relate to epistemic features, such as certainty. I argue, first, that Lambert’s account of moral certainty does not involve any distinctively practical influence on theoretical belief. However, it does present an interesting form of fallibilism about justification as well as a denial of a tight link between knowledge and action. Second, I argue that for Lambert, the persistence principle that underwrites induction is supported by practical reasons to believe; this indicates (...) that Lambert is a moderate pragmatist about reasons for theoretical belief. (shrink)

This paper is concerned with the relation between two important metaphysical notions, ‘truthmaking’ and ‘grounding’. I begin by considering various ways in which truthmaking could be explicated in terms of grounding, noting both strengths and weaknesses of these analyses. I go on to articulate a problem for any attempt to analyze truthmaking in terms of a generic and primitive notion of grounding based on differences we find among examples of grounding. Finally, I outline a more complex view of how truthmaking (...) and grounding could relate. On the view explored, truthmaking is a species of grounding differentiated from other species of grounding by the unique form of dependence it involves. (shrink)