Given the profound public health and economic ramifications of decisions made by the U.S. Food and Drug Administration, the degree to which FDA activities should reflect an approach founded on complete transparency versus one focused on preserving confidentiality of information deserves public discussion. On one hand, reasonable requirements for transparency are critical to stimulating effective innovation, knowledge dissemination, and good business practice. On the other, ensuring the vitality of the medical products industry requires protecting legitimately proprietary information. With current standards (...) reflecting a lengthy accumulation of legal, regulatory, and practical precedent, recent significant changes in the environment in which the FDA operates should prompt a critical examination of current practices. In this article, I comment on Sharfstein and colleagues’ “Blueprint for Transparency,” which calls for multiple specific actions to increase transparency at the agency across five key areas, including interactions between FDA and industry, public disclosure of internal FDA analyses, deliberations concerning generics and biosimilars, expanded access to raw study data, and approaches to countering misleading information in the public sphere. I evaluate these recommendations in light of my experience as a clinician, researcher, and former FDA Commissioner, and reflect on possible outcomes that could result from enacting these practices. (shrink)

Pragmatic clinical trials (PCTs) serve an important function in the modern research landscape: studying interventions in an environment that reflects real-world conditions, rather than the relative...

This book shows that the repeated announcements of the death of Hegel's philosophical system have been premature. Hegel's Philosophy of Freedom, Reality, and God brings to light accomplishments for which Hegel is seldom given credit: unique arguments for the reality of freedom, for the reality of knowledge, for the irrationality of egoism, and for the compatibility of key insights from traditional theism and naturalistic atheism. The book responds in a systematic manner to many of the major criticisms leveled at Hegel's (...) system, from Feuerbach and Kierkegaard to Heidegger and Charles Taylor. It provides detailed interpretations of Hegel's Philosophy of Spirit, large parts of his indispensable Science of Logic, and important parts of his Philosophy of Nature and Philosophy of Right. Unlike many academic books on Hegel, this one treats him very much as a 'live' thinker, whom we can learn from today. (shrink)

It is not too great an exaggeration to claim that On the Origin of Species was, along with Das Kapital, one of the two most significant works in the intellectual history of the nineteenth century. As George Henry Lewes wrote in 1868, ‘No work of our time has been so general in its influence’. However, the very generality of the influence of Darwin’s work provides the chief problem for the intellectual historian. Most books and articles on the subject assert the (...) influence but remain very imprecise about its nature. It is very difficult indeed to assess what it was about the Darwinian theory which was so influential and how its influence was felt. This problem in Victorian intellectual history intersects with a related one in the history of science. There has been a tendency on the part of historians of science to isolate Darwin in two related ways. The first is to single him out from the mainstream of nineteenth-century naturalism in Britain and allow ‘Darwinism’ to stand duty for the wider movement of which it was in fact but a part. The second is the tendency to single out his evolutionary theory and to demarcate it sharply from those of his predecessors and contemporaries. According to this interpretation Darwin stood alone as a real, empirical scientist and provided the first genuinely scientific hypothesis for the process by which evolution might have occurred. The theories of the other main evolutionists—Erasmus Darwin, Lamarck, Chambers, Spencer, and Wallace—were more or less besmirched by ideological, anthropomorphic, or other ‘non-scientific’ factors or by the uses to which they were put by their authors. Charles Darwin is thus made to stand out as a figure of comparatively unalloyed scientific status and is treated in relative isolation from the social and intellectual context in which he worked and into which his theory was received. (shrink)

_Plato's Dialectical Ethics,_ Gadamer's earliest work, has now been translated into English for the first time. This classic book, published in 1931 and reprinted in 1967 and 1982, is still important today. It is one of the most extensive and imaginative interpretations of Plato's _Philebus_ and an ideal introduction to Gadamer's thinking. It shows how his influential hermeneutics emerged from the application of his teacher Martin Heidegger's phenomenological method to classical texts and problems. The work consists of two chapters. The (...) first, which puts Socratic/Platonic dialectics and ethics in the context of Gadamer's thinking about how we come to shared understanding through conversation, helps to clarify the intentions and trajectory of all Gadamer's subsequent work. The second chapter, on the _Philebus, _will interest everyone who is concerned with the connection between Plato's discussions of ethics and those of Aristotle, and with the substantive issues of the relation between pleasure and reason that Plato explores and Gadamer interprets. This edition includes a new and useful introduction by the translator, Robert M. Wallace. (shrink)

Assesses the ethical problems that doctors face every day and advocates a more universal code of medical ethics, one that draws on the traditions of religion and philosophy.

One of our great behavioral scientists, the bestselling author of Behave, plumbs the depths of the science and philosophy of decision-making to mount a devastating case against free will, an argument with profound consequences Robert Sapolsky's Behave, his now classic account of why humans do good and why they do bad, pointed toward an unsettling conclusion: We may not grasp the precise marriage of nature and nurture that creates the physics and chemistry at the base of human behavior, but (...) that doesn't mean it doesn't exist. Now, in Determined, Sapolsky takes his argument all the way, mounting a brilliant (and in his inimitable way, delightful) full-frontal assault on the pleasant fantasy that there is some separate self telling our biology what to do. Determined offers a marvelous synthesis of what we know about how consciousness works-the tight weave between reason and emotion and between stimulus and response in the moment and over a life. One by one, Sapolsky tackles all the major arguments for free will and takes them out, cutting a path through the thickets of chaos and complexity science and quantum physics, as well as touching ground on some of the wilder shores of philosophy. He shows us that the history of medicine is in no small part the history of learning that fewer and fewer things are somebody's "fault"; for example, for centuries we thought seizures were a sign of demonic possession. Yet, as he acknowledges, it's very hard, and at times impossible, to uncouple from our zeal to judge others and to judge ourselves. Sapolsky applies the new understanding of life beyond free will to some of our most essential questions around punishment, morality, and living well together. By the end, Sapolsky argues that while living our daily lives recognizing that we have no free will is going to be monumentally difficult, doing so is not going to result in anarchy, pointlessness, and existential malaise. Instead, it will make for a much more humane world. (shrink)

According to Hegel, the true infinite is the fundamental concept of philosophy. Yet despite this fact, there is absence of consensus concerning its meaning and significance. The true infinite challenges the currently dominant non-metaphysical interpretations of Hegel, as it challenged the dominance of the Kantian framework in its own day, specifically Kant’s attack on theology and his treatment of theology as a postulate of moralit y. Kant admits that the God-postulate has only subjective necessity and validity, and is an expression (...) of moral faith. Hegel both accepts Kant’s approach to the God-question through freedom and practical reason, but he rejects Kant’s philosophy of the postulates as incoherent, burdened with finitude and antithesis. The ought is only the beginning of the transcendence of finitude, but also essentially clings to finitude. This is the spurious infinite. In contrast to the traditional view of abstract transcendence, Hegel shows that the very attempt to separate the infinite from the finite only renders the infinite finite and levels it. The consciousness of limit (finitude) implies a transcendence of limit. The true infinite is an onto-theological principle, a social infinite that overcomes the limits imposed by abstract transcendence and the dualisms imposed by the Kantian frame. It is of vital importance for Hegel’s philosophy of religion, as both a doctrine of divine presence and absolute spirit in its community. (shrink)

Many readers have suspected that Hegel---in arguing against Kant’s individualistic and critical way of approaching ethics and favoring instead an “ethical life” he associates with custom and habit---is in effect eliminating both individual judgment and any basis for criticism of corrupt or unjust communities. Most specialists reject this view of Hegel’s ethical theory, but they haven’t explained precisely how, on the contrary, ethical life preserves individual judgment and criticism within a new way of thinking about ethics. The goal of this (...) paper is to do that. (shrink)

Many readers have suspected that Hegel---in arguing against Kant’s individualistic and critical way of approaching ethics and favoring instead an “ethical life” he associates with custom and habit---is in effect eliminating both individual judgment and any basis for criticism of corrupt or unjust communities. Most specialists reject this view of Hegel’s ethical theory, but they haven’t explained precisely how, on the contrary, ethical life preserves individual judgment and criticism within a new way of thinking about ethics. The goal of this (...) paper is to do that. (shrink)

468 JOURNAL OF THE HISTORY OF PHILOSOPHY 34:3 JULY 1996 right that this distinction need not be a problem for Kant's, or his own, account. Indeed, further discussion of this could be the basis for defending both empirical explanation and a more interpretive or phenomenological understanding of events. But Hudson does not provide this discussion, and without it the "thinkability" of the free agency description is weak. Hudson himself seems uncertain at times as to how much authority to grant to (...) this thinkability. He says, for example, in his Chapter 5 discussion of freedom, that "our first conception of freedom is a causality of reason through which we choose and act on some maxim or law" . Hudson's claim of adequacy for a descrip- tion that does not admit of explanatory certitude demands a more complete defense. This issue highlights, perhaps, the challenges of interpreting.. (shrink)

This major work by the German philosopher Hans Blumenberg is a monumental rethinking of the significance of the Copernican revolution for our understanding of modernity. It provides an important corrective to the view of science as an autonomous enterprise and presents a new account of the history of interpretations of the significance of the heavens for man.Hans Blumenberg is Professor of Philosophy, emeritus, at the University of Munster in West Germany. This book is included in the series Studies in Contemporary (...) German Social Thought, edited by Thomas McCarthy. (shrink)

How should we understand the emotional rationality? This first part will explore two models of cognition and analogy strategies, test their intuition about the emotional desire. I distinguish between subjective and objective desire, then presents with a feeling from the "paradigm of drama" export semantics, here our emotional repertoire is acquired all the learned, and our emotions in the form of an object is fixed. It is pretty well in line with the general principles of rationality, especially the lowest reasonable (...) principles. Turned to the second part of this side of reasonable. I will inquire how emotional beliefs, desires, and behaviors contribute to the rationality. I will present a very general biological hypothesis: emotions by controlling highlights the characteristics of perception and reasoning, so that we remove the difficulties due in particular to lead to paralysis; they are being simulated by a simplified perception of information, thus limiting our practice and cognitive choice. How are we to understand emotional or axiological rationality? I pursue analogies with both the cognitive and the strategic models, testing them against intuitions about emotional desires. We distinguish two different classes of desires, the subjective and the objective, and propose that emotions have a semantics that derives from "paradigmatic scenarios", in terms of which our emotional repertoire is learned and the formal objects of our emotions fixed. This fits in well with emerging facts about how our emotional capacities develop, and it can also be squared with the general principles of rationality, particularly minimal rationality. In the second part, I return to the perspective of rationality. I ask how emotions contribute to the rationality of beliefs, desires, and behavior. I proffer a very general biological hypothesis: Emotions spare us the paralysis potentially induced by a particular predicament by controlling the salience of features of perception and reasoning; they temporarily mimic the informational encapsulation of perception and so circumscribe our practical and cognitive options. (shrink)

It is not too great an exaggeration to claim that On the Origin of Species was, along with Das Kapital, one of the two most significant works in the intellectual history of the nineteenth century. As George Henry Lewes wrote in 1868, ‘No work of our time has been so general in its influence’. However, the very generality of the influence of Darwin’s work provides the chief problem for the intellectual historian. Most books and articles on the subject assert the (...) influence but remain very imprecise about its nature. It is very difficult indeed to assess what it was about the Darwinian theory which was so influential and how its influence was felt. This problem in Victorian intellectual history intersects with a related one in the history of science. There has been a tendency on the part of historians of science to isolate Darwin in two related ways. The first is to single him out from the mainstream of nineteenth-century naturalism in Britain and allow ‘Darwinism’ to stand duty for the wider movement of which it was in fact but a part. The second is the tendency to single out his evolutionary theory and to demarcate it sharply from those of his predecessors and contemporaries. According to this interpretation Darwin stood alone as a real, empirical scientist and provided the first genuinely scientific hypothesis for the process by which evolution might have occurred. The theories of the other main evolutionists—Erasmus Darwin, Lamarck, Chambers, Spencer, and Wallace—were more or less besmirched by ideological, anthropomorphic, or other ‘non-scientific’ factors or by the uses to which they were put by their authors. Charles Darwin is thus made to stand out as a figure of comparatively unalloyed scientific status and is treated in relative isolation from the social and intellectual context in which he worked and into which his theory was received. (shrink)

In celebration of the fortieth anniversary of the publication of Beauchamp and Childress’s Principles of Biomedical Ethics, a review is undertaken to compare the lists of principles in various bioethical theories to determine the extent to which the various lists can be reconciled. Included are the single principle theories of utilitarianism, libertarianism, Hippocratism, and the theories of Pellegrino, Engelhardt, The Belmont Report, Beauchamp and Childress, Ross, Veatch, and Gert. We find theories all offering lists of principles numbering from one to (...) ten. Many of the differences can be reconciled, but some critical differences remain. (shrink)

No one really believes that literally all functions of the entire brain must be lost for an individual to be dead. A better definition of death involves a higher brain orientation.

Clinicians cannot obtain valid consent to treatment because they cannot guess which treatment option will serve a particular patient's best interests. These guesses could be made more accurately if patients were paired with providers who share their deep values.

When a new, brain-based definition of death was proposed fifty years ago, no one realized that the issue would remain unresolved for so long. Recently, six new controversies have added to the debate: whether there is a right to refuse apnea testing, which set of criteria should be chosen to measure the death of the brain, how the problem of erroneous testing should be handled, whether any of the current criteria sets accurately measures the death of the brain, whether standard (...) criteria include measurements of all brain functions, and how minorities who reject whole-brain-based definitions should be accommodated. These controversies leave little hope of consensus on how to define death for social and public policy purposes. Rather, there is persistent disagreement among proponents of three major groups of definitions of death: whole-brain, cardiocirculatory or somatic, and higher-brain. Given the persistence and reasonableness of each of these groups of definitions, public policy should permit individuals and their valid surrogates to choose among them. (shrink)

After distinguishing two different meanings of the notion of a morality internal to medicine and considering a hypothetical case of a society that relied on its surgeons to eunuchize priest/cantors to permit them to play an important religious/cultural role, this paper examines three reasons why morality cannot be derived from reflection on the ends of the practice of medicine: (1) there exist many medical roles and these have different ends or purposes, (2) even within any given medical role, there exists (...) multiple, sometimes conflicting ends, and, most critically, (3) the ends of any practice such as medicine must come from outside the practice, that is, from the basic ends or purposes of human living. The paper concludes by considering whether these ends external to medicine are universally part of the moral reality or whether they are socially constructed. The paper argues that, even if various cultural accounts of the common, universal morality are socially constructed, they may, nevertheless, be reflections, however, imperfect, of a more universal common morality that should be thought of as real. Therefore, the morality of medicine must come from a more fundamental morality external to medicine. That external morality will be socially constructed, but may nevertheless reflect an underlying common morality. (shrink)