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)

This analysis examines whistleblowing within the context of organizational culture. Several factors which have provided impetus for organizations to emphasize ethical conduct and to encourage internal, rather than external, whistleblowing are identified. Inadequate protection for whistleblowers and statutory enticement for them to report ethical violations externally are discussed. Sundstrand's successful model for cultural change and encouragement of internal whistleblowing is analyzed to show how their model of demonstrating management's commitment to ethical conduct, establishing ethical expectations of employees, training to ensure (...) that employees understand the concepts and expectations, promoting of employee ownership of the program, making the program visible, protecting the whistleblower and undertaking periodic reviews of the program's success may serve as a model for other organizations. (shrink)

In transplant medicine, the use of normothermic regional perfusion (NRP) in donation after circulatory determination of death raises ethical difficulties. NRP is objectionable because it restores the donor's circulation, thus invalidating a death declaration based on the permanent cessation of circulation. NRP's defenders respond with arguments that are tortuous and factually inaccurate and depend on introducing extraneous concepts into the law. However, results comparable to NRP's—more and higher‐quality organs and more efficient allocation—can be achieved by removing organs from deceased donors (...) and using normothermic machine perfusion (NMP) to support the organs outside the body, without jeopardizing confidence in transplantation's legal and ethical foundations. Given the controversy that NRP generates and the convoluted justifications made for it, we recommend a prudential approach we call “ethical parsimony,” which holds that, in the choice between competing means of achieving a result, the ethically simpler one is to be preferred. This approach makes clear that policy‐makers should favor NMP over NRP. (shrink)

In a pioneering book, Philosophy of Microbiology, Maureen O’Malley argues for the philosophical importance of microbes through an examination of their impact on ecosystems, evolution, biological classification, collaborative behavior, and multicellular organisms. She identifies many understudied conceptual issues in the study of microbes. If philosophers follow her lead, the philosophy of biology will be expanded and enriched.

We present a one per cent measurement of the cosmic distance scale from the detections of the baryon acoustic oscillations in the clustering of galaxies from the Baryon Oscillation Spectroscopic Survey, which is part of the Sloan Digital Sky Survey III. Our results come from the Data Release 11 sample, containing nearly one million galaxies and covering approximately 8500 square degrees and the redshift range 0.2 < z < 0.7. We also compare these results with those from the publicly released (...) DR9 and DR10 samples. Assuming a concordance Λ cold dark matter cosmological model, the DR11 sample covers a volume of 13 Gpc3 and is the largest region of the Universe ever surveyed at this density. We measure the correlation function and power spectrum, including density-field reconstruction of the BAO feature. The acoustic features are detected at a significance of over 7σ in both the correlation function and power spectrum. Fitting for the position of the acoustic features measures the distance relative to the sound horizon at the drag epoch, rd, which has a value of rd,fid = 149.28 Mpc in our fiducial cosmology. We find DV = at z = 0.32 and DV = at z = 0.57. At 1.0 per cent, this latter measure is the most precise distance constraint ever obtained from a galaxy survey. Separating the clustering along and transverse to the line of sight yields measurements at z = 0.57 of DA = and H =. Our measurements of the distance scale are in good agreement with previous BAO measurements and with the predictions from cosmic microwave background data for a spatially flat CDM model with a cosmological constant. © 2014 The Author Published by Oxford University Press on behalf of the Royal Astronomical Society. (shrink)

The practical question about God's relation to human freedom isthe issue between Nietzsche and Sartre, on the one hand, and Marcel,on the other. God is compatible with human freedom, for Marcel,because He is conceived as an absolute “Thou,” not an objectivecause, and because human freedom is essentially disposability, openand receptive to the other. God is relevant to human freedom becauseHe is more intimate to me than I am to myself, because He can re-veal to me possibilities about myself and the (...) world which I can thenaccept or reject. If the other is essential for self-knowledge in thefinite sphere, then the absolute Other is essential for the deepestself-knowledge. Also God is essential as the ground of that hopewithout which creative fidelity would die.The most fundamental question, therefore, of the atheism-theismdebate is the nature of freedom. If freedom is conceived in an “either-or” manner as totally subjective, independent, and closed in uponitself, then there is an essential antagonism between man and God.If freedom is conceived in a “both-and” fashion as both independentand dependent, active and receptive, personally responsible and yetopen to the other, then there is not antagonism, but rather fruitfulinteraction. One of Gabriel Marcel's major contributions to existentialphilosophy and the philosophy of religion is to have indicated theplausibility and fruitfulness of such a model. (shrink)

I examine the metaphysical issue of the nature of color. I argue that there are two distinct ranges of colors, namely, physical colors, which are disjunctive monadic physical properties of physical objects, and mental colors, which are properties of neural processes. ;A pair of claims provide the motivation for subjectivist and dispositionalist proposals about the nature of color, proposals which I reject. The first claim holds that a description of colors according to our ordinary experience of color provides a specification (...) of some aspects of the nature of color. The second holds that our ordinary experience of color provides access to the nature of color. ;In chapter 1, I argue that visual experiences have mental colors, neural properties which importantly determine our color categories. However, I reject C. L. Hardin's and James A. McGilvray's arguments for the subjectivist claim that the colors we attribute to physical objects are mental colors. ;In chapter 2, I show that Paul A. Boghossian and J. David Velleman's arguments in support of subjectivism rely on the assumption that visual experience provides unqualified access to the nature of color. I argue, however, that objections to their projectivism about color perception provide strong reasons to reject subjectivism as well as their assumption that visual experience provides unqualified access to the nature of color. ;In chapters 3 and 4, I examine Mark Johnston's and Christopher Peacocke's dispositionalist proposals about the nature of physical colors, which are founded on the claim that ordinary visual experience provides access to an aspect of the nature of color. I undercut dispositionalism by rejecting their arguments for the claim that ordinary visual experience provides such access. ;In chapter 5, I show that Evan Thompson's proposal that the colors of objects are relations between properties of perceivers and objects assumes that a description of color according to our ordinary experience specifies some aspects of the nature of color. I reject this assumption by distinguishing between mental color and physical color. I conclude that rather than specifying the nature of color, descriptions of colors according to our ordinary experience merely serve to fix the reference of color terms. (shrink)

Professor Lauer at the beginning of his book makes clear what he is doing by indicating what he is not doing. He is not giving a commentary, like Hyppolite, nor a genial discussion of the issue, like Lowenberg. Lauer’s is a reading of the Phenomenology, not the only reading or even the best reading, but a plausible one that he hopes will spare others the tortures he himself had to go through in understanding Hegel and that will facilitate one’s own (...) reading of this difficult work. In the opinion of this reviewer, Lauer largely succeeds in his project. (shrink)

They envisioned a brave new world, and what they got was fascism. As vibrant as its counterparts in Paris, Munich, and Milan, the avant-garde of Florence rose on a wave of artistic, political, and social idealism that swept the world with the arrival of the twentieth century. How the movement flourished in its first heady years, only to flounder in the bloody wake of World War I, is a fascinating story, told here for the first time. It is the history (...) of a whole generation's extraordinary promise--and equally extraordinary failure. The "decadentism" of D'Annunzio, the philosophical ideals of Croce and Gentile, the politics of Italian socialism: all these strains flowed together to buoy the emerging avant-garde in Florence. Walter Adamson shows us the young artists and writers caught up in the intellectual ferment of their time, among them the poet Giovanni Papini, the painter Ardengo Soffici, and the cultural critic Giuseppe Prezzolini. He depicts a generation rejecting provincialism, seeking spiritual freedom in Paris, and ultimately blending the modernist style found there with their own sense of toscanità or "being Tuscan." In their journals--Leonardo, La Voce, Lacerba, and l'Italia futurista--and in their cafe life at the Giubbe Rosse, we see the avant-garde of Florence as citizens of an intellectual world peopled by the likes of Picasso, Bergson, Sorel, Unamuno, Pareto, Weininger, and William James. We witness their mounting commitment to the ideals of regenerative violence and watch their existence become increasingly frenzied as war approaches. Finally, Adamson shows us the ultimate betrayal of the movement's aspirations as its cultural politics help catapult Italy into war and prepare the way for Mussolini's rise to power. (shrink)

J. L. Austin, in "Ifs and Cans," proclaimed the common hope that we soon "may see the birth, through the joint labors of philosophers, grammarians, and numerous other students of language, of a true and comprehensive science of language." The problem has always been with the "joint labors" part. Philosophers have always been willing to issue linguists dictums and linguists have been happy to teach philosophers "plain facts." Austin’s general view of language, and his particular notion of performative utterance, can (...) be found in the writing of J. R. Firth, the most commanding British linguist of Austin’s generation, but Austin never refers to Firth. In the present volume, however, we find clear and exciting evidence of genuinely joint labors on the part of philosophers and linguists. They stem from a summer conference in 1969 rounded out with contributions from notables. To two thick issues of Synthese the editors have added a dazzling piece by Saul Kripke, two substantial pieces by James McCawley and J. R. Ross, a short paper by Paul Ziff, and a reprint of P. F. Strawson’s "Grammar and Philosophy." This is an invaluable book and the best book among the many now available concerning the interaction of linguistics and philosophy: worth the cost, which the contributors attempted to reduce through foregoing royalties. The philosophers in this volume hold, or hold intriguing, the view that the semantics of a natural language can and must, in effect, be a theory of truth for a language in much the manner that Tarski suggested, and provided, for artificial language: the recursive specification of biconditionals in which the left hand gives the structural description of an object language sentence and the right hand, the truth conditions in the metalanguage. In "homophonic" translation this requirement can be trivially satisfied simply by mentioning the sentence on the left that one uses on the right: one makes the requirement non-trivial by forcing enough into the recursive specification so that one captures the native speaker’s implicit semantic competence. In this volume, the "orthodox" Davidsonian program, which takes the syntax of the metalanguage to be standard predicate logic, is ably argued by John Wallace ; Richard Montague, David Lewis, and Jaakko Hintikka would want an intensional logic covering modality and propositional attitudes. The linguists who find this philosophical climate most appealing are called "generative semanticists": McCawley, Ross, George Lakoff and others argue that any proposed semantic rule will eventually prove necessary to syntax too and that, hence, the deepest level of syntactical form will be equivalent to semantic form. Whatever the ultimate fate of this joint program, it leads here to much exciting interaction between linguists and philosophers: linguists who welcome the machinery and conceptual standards of modern logic, and philosophers who try to grasp the specifics of crucial issues in recent linguistic theory. Even if Quine’s doubts, here sketched, and Chomsky’s currently unpublished more technical objections should be well-founded, nonetheless the joint labor will have been very much worthwhile. Aside from this general debate about semantics, there are several papers covering more specific issues. The papers of J. A. Fodor, Terence Parsons, and Ross concern adverbs and the logical form of action sentences; several papers, particularly B. H. Partee’s, examine "Opacity, Coreference, and Pronouns." In all these papers one notes the fulfillment of Austin’s hope that philosophic and linguistic arguments should become intermixed, if not at times properly indistinguishable. Perhaps the most enjoyable and exciting paper stands aside from linguistics: Saul Kripke’s "Naming and Necessity." Kripke here argues quite informally for the separation of analytic, a priori, and necessary that is required for a Kripke style, S5, modal logic with de re modalities. "Gold is a yellow metal," for example, turns out to be contingent, while "Heat is the motion of particles" is necessary but a posteriori ; and that philosopher’s stone of stones, "The morning star is the evening star," is discovered to be necessary but a posteriori.—J. L. (shrink)

Organ donation after the circulatory determination of death requires the permanent cessation of circulation while organ donation after the brain determination of death requires the irreversible cessation of brain functions. The unified brain-based determination of death connects the brain and circulatory death criteria for circulatory death determination in organ donation as follows: permanent cessation of systemic circulation causes permanent cessation of brain circulation which causes permanent cessation of brain perfusion which causes permanent cessation of brain function. The relevant circulation that (...) must cease in circulatory death determination is that to the brain. Eliminating brain circulation from the donor ECMO organ perfusion circuit in thoracoabdominal NRP protocols satisfies the unified brain-based determination of death but only if the complete cessation of brain circulation can be proved. Despite its medical and physiologic rationale, the unified brain-based determination of death remains inconsistent with the Uniform Determination of Death Act. (shrink)

In a seminal 1977 article, Rumelhart argued that perception required the simultaneous use of multiple sources of information, allowing perceivers to optimally interpret sensory information at many levels of representation in real time as information arrives. Building on Rumelhart's arguments, we present the Interactive Activation hypothesis—the idea that the mechanism used in perception and comprehension to achieve these feats exploits an interactive activation process implemented through the bidirectional propagation of activation among simple processing units. We then examine the interactive activation (...) model of letter and word perception and the TRACE model of speech perception, as early attempts to explore this hypothesis, and review the experimental evidence relevant to their assumptions and predictions. We consider how well these models address the computational challenge posed by the problem of perception, and we consider how consistent they are with evidence from behavioral experiments. We examine empirical and theoretical controversies surrounding the idea of interactive processing, including a controversy that swirls around the relationship between interactive computation and optimal Bayesian inference. Some of the implementation details of early versions of interactive activation models caused deviation from optimality and from aspects of human performance data. More recent versions of these models, however, overcome these deficiencies. Among these is a model called the multinomial interactive activation model, which explicitly links interactive activation and Bayesian computations. We also review evidence from neurophysiological and neuroimaging studies supporting the view that interactive processing is a characteristic of the perceptual processing machinery in the brain. In sum, we argue that a computational analysis, as well as behavioral and neuroscience evidence, all support the Interactive Activation hypothesis. The evidence suggests that contemporary versions of models based on the idea of interactive activation continue to provide a basis for efforts to achieve a fuller understanding of the process of perception. (shrink)

Scepticism about ought simpliciter is the view that there is no such thing as what one ought simpliciter to do. Instead, practical deliberation is governed by a plurality of normative standpoints, each authoritative from their own perspective but none authoritative simpliciter. This paper aims to resist such scepticism. After setting out the challenge in general terms, I argue that scepticism can be resisted by rejecting a key assumption in the sceptic’s argument. This is the assumption that standpoint-relative ought judgments bring (...) with them a commitment to act in accordance with those judgments. Instead, I propose an alternative account of our normative concepts according to which only ought simpliciter judgments commit one to acting in accordance with those judgments. In addition to answering the sceptical challenge, the proposal offers an independently motivated account of what makes a concept normatively authoritative. (shrink)

Notwithstanding these wise pronouncements, my project here is to characterize the biological phenomenon of death of the higher animal species, such as vertebrates. My claim is that the formulation of “whole- brain death ” provides the most congruent map for our correct understanding of the concept of death. This essay builds upon the foundation my colleagues and I have laid since 1981 to characterize the concept of death and refine when this event occurs. Although our society's well-accepted program of multiple (...) organ procurement for transplantation requires the organ donor first to be dead, the concept of brain death is not merely a social contrivance to permit us to obtain the benefits of organ procurement. Rather, the concept of whole- brain death stands independently as the most accurate biological representation of the demise of the human organism. (shrink)

In this interview, James L. McClelland responds to questions regarding connectionist models of cognition, a theory inspired by information processing in the brain. McClelland explains the distinction between symbolic and non-symbolic processing for a better understanding of mental processes. He argues that connectionist models can perform the computations which we know the brain can perform. In addition, he responds to several general questions on the perspectives of computational models of cognition.

Abstract:Disturbing cases continue to be published of patients declared brain dead who later were found to have a few intact brain functions. We address the reasons for the mismatch between the whole-brain criterion and brain death tests, and suggest solutions. Many of the cases result from diagnostic errors in brain death determination. Others probably result from a tiny amount of residual blood flow to the brain despite intracranial circulatory arrest. Strategies to lessen the mismatch include improving brain death determination training (...) for physicians, mandating a test showing complete intracranial circulatory arrest, or revising the whole-brain criterion. (shrink)

This paper examines the general prospects for conceptual role expressivism, expressivist theories that embrace conceptual role semantics. It has two main aims. The first aim is to provide a general characterisation of the view. The second aim is to raise a challenge for the general view. The challenge is to explain why normative concepts are not a species of defective concepts, where defective concepts are those that cannot meaningfully embed and participate in genuine inference. After rejecting existing attempts to answer (...) the challenge, I propose an alternative solution. However, the solution leaves conceptual role expressivism a far less distinctive and interesting position than its proponents claim. I conclude that we should be sceptical about how much expressivists gain by appealing to conceptual role semantics. (shrink)

Metaethical expressivism is typically characterised as the view that normative statements express desire-like attitudes instead of beliefs. However, in this paper I argue that expressivists should claim that normative statements express beliefs in normative propositions, and not merely in some deflationary sense but in a theoretically robust sense explicated by a theory of propositional attitudes. I first argue that this can be achieved by combining an interpretationist understanding of belief with a nonfactualist view of normative belief content. This results in (...) a view I call ‘interpretative expressivism’. I then argue that traditional arguments employed by expressivists that normative statements express noncognitive attitudes can just as well support the claim that normative statements express nonfactual or nonrepresentational beliefs. Finally, I argue that this view has a number of advantages to versions of expressivism that deny that normative statements express non-deflationary normative beliefs. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Philosophy and Rhetoric 35.2 (2002) 138-152 [Access article in PDF] Respecting the Rupture: Not Solving the Problem of Unity in Plato's Phaedrus James L. Kastely Plato's Phaedrus is a particularly instructive example of the double nature and status of rhetoric, for it embodies a tension at the heart of rhetoric. The first half of the dialogue presents three examples of rhetorical practice, while the second develops a theoretical (...) justification of rhetoric as an art. Thus, the dialogue would seem to offer a productive negotiation of the practice/theory tension. What makes the dialogue interesting, however, is the fact that this negotiation does not occur. The dialogue does not bring theory and practice into a harmonious relation, for there is a troubling discontinuity between its two halves, and rhetorical practice feels fractured. The exploration of eros that had occupied the first half of the dialogue is abandoned before the beginning of the second half, and then, following a logic that is at best associational, Socrates and Phaedrus explore the standards that should govern the practice of rhetoric. The infelicity of this transition raises a question: why did Plato structure the Phaedrus in such a way that it emphasized the dissonance between the two halves of the dialogue? To pose the question this way, however, is to go in a direction different from many of the best contemporary interpretations of the dialogue, which either argue that the dialogue is unified (Griswold 164) or suggest that the dissonance between its two halves reflects a shift in Plato's approach to philosophy (Kahn 373; Nehamas 352). In contrast, I will argue that the rupture in the dialogue is thematically purposive, for it points to an inescapable schism within rhetoric that makes rhetoric philosophically interesting.Socrates' second speech, his palinode to Eros, is a rhetorical tour de force that closes the first half of the dialogue. The importance of the palinode, however, is not limited to its role as an exemplary rhetorical performance, [End Page 138] for it also plays a crucial role in resolving the problem of erotic madness that organizes the intellectual drama of the first half. It would seem reasonable to expect that such an important and powerful moment in the dialogue would, at the very least, play a significant role in the philosophical discussion that composes the dialogue's second half. But that doesn't happen. While Socrates does refer to the palinode in his theoretical discussion of rhetoric, he makes little use of it, and, more important, he is silent on the subject of eros. Both the dramatic organization of the second half of the dialogue and its theoretical discussion cooperate to turn the rhetorical triumph of the palinode into a problem. Why has eros been abandoned as a philosophic topic, and what does this abandoning imply about the erotically grounded rhetoric that Socrates practiced and defended?To make matters worse, Socrates himself dismisses the palinode as a serious effort. He characterizes the speech as little more than a pleasant game, one that is not without value only because "these two certain forms (of gathering and dividing) were stated by chance" (265c). Far from viewing the palinode as possessing philosophical significance, Socrates appears to value it principally for its being a so-so example of a work of rhetoric that has been shaped by dialectic. While it is hard not to take Socrates' dismissal of the seriousness of the speech as partially disingenuous (just prior to his dismissal, he refers to the palinode as serious and reverent [265b]), he also does seem to mean what he says. Whether he is being straightforward or ironic does not finally matter because in either case the problem that occupies him and Phaedrus in the first half has disappeared from the dialogue. And that creates a problem: for if the philosophic issues of the first half of the dialogue drop out, then the dialogue is not coherent.This incoherence is especially troubling given Socrates' explicit endorsement of coherence as an important rhetorical value. In fact, when he begins his... (shrink)

The definition of death is one of the oldest and most enduring problems in biophilosophy and bioethics. Serious controversies over formally defining death began with the invention of the positive-pressure mechanical ventilator in the 1950s. For the first time, physicians could maintain ventilation and, hence, circulation on patients who had sustained what had been previously lethal brain damage. Prior to the development of mechanical ventilators, brain injuries severe enough to induce apnea quickly progressed to cardiac arrest from hypoxemia. Before the (...) 1950s, the loss of spontaneous breathing and heartbeat were perfect predictors of death because the functioning of the brain and of all other organs ceased rapidly and nearly simultaneously thereafter, producing a unitary death phenomenon. In the pretechnological era, physicians and philosophers did not have to consider whether a human being who had lost certain “vital functions” but had retained others was alive, because such cases were technically impossible. (shrink)