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 introduction to the Common Knowledge symposium titled “Comparative Relativism” outlines a variety of intellectual contexts where placing the unlikely companion terms comparison and relativism in conjunction offers analytical purchase. If comparison, in the most general sense, involves the investigation of discrete contexts in order to elucidate their similarities and differences, then relativism, as a tendency, stance, or working method, usually involves the assumption that contexts exhibit, or may exhibit, radically different, incomparable, or incommensurable traits. Comparative studies are required to (...) treat their objects as alike, at least in some crucial respects; relativism indicates the limits of this practice. Jensen argues that this seeming paradox is productive, as he moves across contexts, from Lévi-Strauss's analysis of comparison as an anthropological method to Peter Galison's history of physics, and on to the anthropological, philosophical, and historical examples offered in symposium contributions by Barbara Herrnstein Smith, Eduardo Viveiros de Castro, Marilyn Strathern, and Isabelle Stengers. Comparative relativism is understood by some to imply that relativism comes in various kinds and that these have multiple uses, functions, and effects, varying widely in different personal, historical, and institutional contexts that can be compared and contrasted. Comparative relativism is taken by others to encourage a “comparison of comparisons,” in order to relativize what different peoples—say, Western academics and Amerindian shamans—compare things “for.” Jensen concludes that what is compared and relativized in this symposium are the methods of comparison and relativization themselves. He ventures that the contributors all hope that treating these terms in juxtaposition may allow for new configurations of inquiry. (shrink)

Significant associations have been found between specific human leukocyte antigen (HLA) alleles and organ transplant rejection, autoimmune disease development, and the response to infection. Traditional searches for disease associations have conventionally measured risk associated with the presence of individual HLA alleles. However, given the high level of HLA polymorphism, the pattern of amino acid variability, and the fact that most of the HLA variation occurs at functionally important sites, it may be that a combination of variable amino acid sites shared (...) by several alleles (shared epitopes) are better descriptors of the actual causative genetic variants. Here we describe a novel approach to genetic association analysis in which genes/proteins are broken down into smaller sequence features and then variant types defined for each feature, allowing for independent analysis of disease association with each sequence feature variant type. We have used this approach to analyze a cohort of systemic sclerosis patients and show that a sequence feature composed of specific amino acid residues in peptide binding pockets 4 and 7 of HLA-DRB1 explains much of the molecular determinant of risk for systemic sclerosis. (shrink)

Intuitionism is most commonly defined in terms of various strong epistemological and metaphysical presuppositions, e.g., that true moral principles are synthetic a priori propositions, known by some special faculty of moral reflection, and the like. I shall not here be concerned with such views. Rather my focus will be upon the program for normative investigation which I have elsewhere argued is implicit in the intuitionists’ writings and which I take to be intuitionism's salient characteristic.

This piece is a response to Barbara Herrnstein Smith's article, “The Chimera of Relativism: A Tragicomedy,” in the Common Knowledge symposium on “comparative relativism.” The theme is complexity—as distinct from simple contrast or binarism of any kind—similarities as well as differences are observed in ancient Chinese and ancient Greek responses to cultural difference; also the significantly different views of these matters among the Greek philosophers. In the same vein, discussing studies of cultural/linguistic variability or counterclaimed universality among humans in (...) color perception, the essay stresses the complexity of such cognitive activities, including the ongoing interactions among the multiple variables presumably involved. Noting the challenge that such intrinsic complexity and inevitable interactivity present to standard dichotomies of universality and cultural relativity, the essay concludes that these and other familiar dualisms have been made obsolete by a century of research in genetics, ethnography, and related empirical disciplines. (shrink)

The title of this book should be read as a pun, for Smith thinks that the term "religion" has no precise or useful meaning and should be put an end to. He argues primarily as an historian, but his book poses a serious and deliberate challenge to the philosopher of religion. He proposes a mild language reform, the substitution of the two categories "cumulative tradition" and "faith" for the single one "religion." He gives some good positive reasons for this. (...) But too much of his book is devoted to historical accounts of the origins and use of the term "religion" within various cultures, and of the different proper names of religions. As the arguments progress, it becomes clear that the language reform he really wants to make is to employ only the category of "faith" understood as personal piety. There is a good deal of confusion at the theoretical level, but the issue is important, the positive contribution valuable and the challenge to clarity much needed.—W. G. E. (shrink)

An interpretative introduction to the major themes of classic American philosophy and five of its major figures: Peirce, James, Royce, Dewey and Whitehead. Smith shows sympathy and insight into these men and their ideas, making an excellent choice of basic themes for discussion. Running throughout the book is a sustained argument for a renewal of the breadth of philosophic interest and the sound empirical basis displayed by Pragmatism at its best. Smith is concerned that this "Spirit of American (...) Philosophy" be rescued from the neglect it has suffered over the past decades and be recalled to the attention of the philosophic community. His book is an admirable step in that direction.--W. G. E. (shrink)

The most powerful lesson learned from the 2013-2016 outbreak of Ebola in West Africa was that we do not learn our lessons. A common sentiment at the time was that Ebola served as a “wake-up call”—an alarm which signalled that an outbreak of that magnitude should never have occurred and that we are ill-prepared globally to prevent and respond to them when they do. Pledges were made that we must learn from the outbreak before we were faced with another. Nearly (...) five years later the world is in the grips of a pandemic of the severe acute respiratory syndrome coronavirus 2 that causes coronavirus disease 2019. It is therefore of no surprise that we are now yet again hearing that the COVID-19 pandemic serves as the “wake-up call” we need and that there are many lessons to be learned to better prepare us for future outbreaks. Will anything be different this time around? We argue that nothing will fundamentally change unless we truly understand and appreciate the nature of the lessons we should learn from these outbreaks. Our past failures must be understood as moral failures that offer moral lessons. Unless we appreciate that we have a defect in our collective moral attitude toward remediating the conditions that precipitate the emergence of outbreaks, we will never truly learn. (shrink)

The exercise of identifying lessons in the aftermath of a major public health emergency is of immense importance for the improvement of global public health emergency preparedness and response. Despite the persistence of the Ebola Virus Disease outbreak in West Africa, it seems that the Ebola ‘lessons learned’ exercise is now in full swing. On our assessment, a significant shortcoming plagues recent articulations of lessons learned, particularly among those emerging from organizational reflections. In this article we argue that, despite not (...) being recognized as such, the vast majority of lessons proffered in this literature should be understood as ethical lessons stemming from moral failures, and that any improvements in future global public health emergency preparedness and response are in large part dependent on acknowledging this fact and adjusting priorities, policies and practices accordingly such that they align with values that better ensure these moral failures are not repeated and that new moral failures do not arise. We cannot continue to fiddle at the margins without critically reflecting on our repeated moral failings and committing ourselves to a set of values that engenders an approach to global public health emergencies that embodies a sense of solidarity and global justice. (shrink)

The relevance of Marx’s theory of value and his ‘law of the tendency of the rate of profit to fall’ to the analysis of the financial crisis of 2007–8 and the ensuing global slump is affirmed. The hypertrophic growth of unproductive constant capital, including the wages of ‘socially necessary’ unproductive labour and tax revenues, is identified as an important manifestation of an historical-structural crisis of capitalism, alongside the increasing weight of fictitious capital and the proliferation of fictitious profits in the (...) lead-up to the financial crisis. These phenomena have obscured the deepest roots of the global slump in the long-term profitability problems of productive capital – that is, in a crisis of surplus-value production. With these considerations taken into account, a better empirical assessment of trends in the composition of capital becomes possible, and with it a more accurate understanding of the impact of the ongoing displacement of living labour from production on the average rate of profit and the future of US and global capitalism. (shrink)

The controversy surrounding the status of dialectics in Marxist thought has failed to take the full measure of the persistent influence of ontological dualism and its corollary, dualistic social ontology. Yet an explicit critique of dualism is essential to materialist dialectics and to a Marxist-socialist theory and pedagogy that discloses the specific role of capitalist social relations in impeding human progress. A dialectical-monistic ontology associated with Marx's "new" (historical) materialism requires systematic conceptual elaboration, as illuminated by a dialecticalontological triad embracing (...) "the natural," "the social" and "conscious activity." The usefulness of this triad is illustrated by exploring how dialectical-monistic and dualistic ontologies stimulate very different ways of understanding a key question in social theory: the concept of economic value. (shrink)

Discussion surrounding Marx's distinction between productive and unproductive labor too often fails to distinguish between the various forms that unproductive labor may assume and is too hasty to subsume the income of workers "unproductively" employed by capital as a non-profit component of social surplus-value. Against this, it may be argued that many forms of unproductive labor are socially necessary to the social capital and are therefore properly viewed as systemic overhead costs. As such, they should be treated, in value-theoretical terms, (...) as elements of the constant capital flow. The implications of this approach are explored for crisis theory and the evolution of the class structure with particular reference to the Canadian experience in this century. (shrink)

The issue of the theory-ladenness of observation has long troubled philosophers of science, largely because it seems to threaten the objectivity of science. However, the way in which prior beliefs influence the perception of data is in part an empirical issue that can be investigated by cognitive psychology. This point is illustrated through an experimental analogue of scientific data-interpretation tasks in which subjects judging the covariation between personality variables based their judgments on pure data, their theoretical intuitions about the variables, (...) or both data and prior theoretical beliefs. Results showed that the perceived magnitude of correlations was greatest when subjects relied solely on theoretical intuitions; that data-based judgments were drawn in the direction of those prior beliefs; but that exposure to data nonetheless moderated the strength of the prior theories. In addition, prior beliefs were found to influence judgments only after a brief priming interval, suggesting that subjects needed time to retrieve their theoretical intuitions from memory. These results suggest ways to investigate the processes mediating theory-laden observation, and, contrary to the fears of positivist philosophers, imply that the theory-ladenness of observation does not entail that theoretical beliefs are immune to data. (shrink)

The idea that human history evinces a pattern of development rooted in the propensity of human beings toward technical forms of rationality is fundamental to Marx's materialist conception of history. Yet the "dialectic of forces and relations of production" as traditionally conceived in historical-materialist discourse has found only weak expressions in social formations dominated by precapitalist modes of production. The hypothesis is advanced that the role of simple commodity production and exchange in such formations may be decisive to the emergence (...) of cognitive faculties capable of giving a systematic impulse to the development of science and technology, and therefore to a precapitalist forces-relations dialectic. This suggests a new way of appreciating Marx's "ranking" of the Asiatic, ancient, feudal and capitalist modes of production as "progressive epochs" in the development of human society, while illuminating the socio-historical provenance (and sources of variability) of the categories of human thought. (shrink)

In this chapter we extend earlier work (Vinuesa et al., Nat Commun 11, 2020) on the potential of artificial intelligence (AI) to achieve the 17 Sustainable Development Goals (SDGs) proposed by the United Nations (UN) for the 2030 Agenda. The present contribution focuses on three SDGs related to healthy and sustainable societies, i.e., SDG 3 (on good health), SDG 11 (on sustainable cities), and SDG 13 (on climate action). This chapter extends the previous study within those three goals and goes (...) beyond the 2030 targets. These SDGs are selected because they are closely related to the coronavirus disease 19 (COVID-19) pandemic and also to crises like climate change, which constitute important challenges to our society. (shrink)

This article is part of a For-Discussion-Section of Methods of Information in Medicine about the paper "Biomedical Informatics: We Are What We Publish", written by Peter L. Elkin, Steven H. Brown, and Graham Wright. It is introduced by an editorial. This article contains the combined commentaries invited to independently comment on the Elkin et al. paper. In subsequent issues the discussion can continue through letters to the editor.

People have always been xenophobic, but an explicit philosophical and scientific view of human racial difference only began to emerge during the modern period. Why and how did this happen? Surveying a range of philosophical and natural-scientific texts, dating from the Spanish Renaissance to the German Enlightenment, Nature, Human Nature, and Human Difference charts the evolution of the modern concept of race and shows that natural philosophy, particularly efforts to taxonomize and to order nature, played a crucial role. Smith (...) demonstrates how the denial of moral equality between Europeans and non-Europeans resulted from converging philosophical and scientific developments, including a declining belief in human nature's universality and the rise of biological classification. The racial typing of human beings grew from the need to understand humanity within an all-encompassing system of nature, alongside plants, minerals, primates, and other animals. While racial difference as seen through science did not arise in order to justify the enslavement of people, it became a rationalization and buttress for the practices of trans-Atlantic slavery. From the work of François Bernier to G. W. Leibniz, Immanuel Kant, and others, Smith delves into philosophy's part in the legacy and damages of modern racism. With a broad narrative stretching over two centuries, Nature, Human Nature, and Human Difference takes a critical historical look at how the racial categories that we divide ourselves into came into being. (shrink)

Scholars of classical philosophy have long disputed whether Aristotle was a dialectical thinker. Most agree that Aristotle contrasts dialectical reasoning with demonstrative reasoning, where the former reasons from generally accepted opinions and the latter reasons from the true and primary. Starting with a grasp on truth, demonstration never relinquishes it. Starting with opinion, how could dialectical reasoning ever reach truth, much less the truth about first principles? Is dialectic then an exercise that reiterates the prejudices of one's times and at (...) best allows one to persuade others by appealing to these prejudices, or is it the royal road to first principles and philosophical wisdom? In From Puzzles to Principles? May Sim gathers experts to argue both these positions and offer a variety of interpretive possibilities. The contributors' thoughtful reflections on the nature and limits of dialectic should play a crucial role in Aristotelian scholarship. (shrink)

ABSTRACT Real-time graphical interval logic is a modal logic for reasoning about time in which the basic modality is the interval. The logic differs from other logics in that it has a natural intuitive graphical representation that resembles the timing diagrams drawn by system designers. We have developed an automted deduction system for the logic, which includes a theorem prover and a user interface. The theorem prover checks the validity of proofs in the logic and produces counterexamples to invalid proofs. (...) The user interface includes a graphical editor that enables the user to create graphical formulas on a workstation display, and a database and proof manager that tracks proof dependencies and allows graphical formulas to be stored and retrieved. In this paper we describe the logic, the automated deduction system, and an application to robotics. (shrink)

The fusion of law and equity in common law systems was a crucial moment in the development of the modern law. In this volume leading scholars assess the significance of the fusion of law and equity from comparative, doctrinal, historical and theoretical perspectives.

Though it did not yet exist as a discrete field of scientific inquiry, biology was at the heart of many of the most important debates in seventeenth-century philosophy. Nowhere is this more apparent than in the work of G. W. Leibniz. In Divine Machines, Justin Smith offers the first in-depth examination of Leibniz's deep and complex engagement with the empirical life sciences of his day, in areas as diverse as medicine, physiology, taxonomy, generation theory, and paleontology. He shows how (...) these wide-ranging pursuits were not only central to Leibniz's philosophical interests, but often provided the insights that led to some of his best-known philosophical doctrines.Presenting the clearest picture yet of the scope of Leibniz's theoretical interest in the life sciences, Divine Machines takes seriously the philosopher's own repeated claims that the world must be understood in fundamentally biological terms. Here Smith reveals a thinker who was immersed in the sciences of life, and looked to the living world for answers to vexing metaphysical problems. He casts Leibniz's philosophy in an entirely new light, demonstrating how it radically departed from the prevailing models of mechanical philosophy and had an enduring influence on the history and development of the life sciences. Along the way, Smith provides a fascinating glimpse into early modern debates about the nature and origins of organic life, and into how philosophers such as Leibniz engaged with the scientific dilemmas of their era. (shrink)