There is a gap between health economic evaluation methods and the value judgments of coverage decision makers, at least in Germany. Measuring preference satisfaction has been claimed to be inappropriate for allocating health care resources, e.g. because it disregards medical need. The existing methods oriented at medical need have been claimed to disregard non-consequentialist fairness concerns. The aim of this article is to propose a new, contractarian argument for justifying needs-based economic evaluation. It is based on consent rather than maximization (...) of some impersonal unit of value to accommodate the fairness concerns. This conceptual paper draws upon contractarian ethics and constitution economics to show how economic evaluation can be viewed as an institution to overcome societal conflicts in the allocation of scarce health care resources. For this, the problem of allocating scarce health care resources in a society is reconstructed as a social dilemma. Both disadvantaged patients and affluent healthy individuals can be argued to share interests in a societal contract to provide technologies which ameliorate medical need, based on progressive funding. The use of needs-based economic evaluation methods for coverage determination can be interpreted as institutions for conflict resolution as far as they use consented criteria to ensure the social contract’s sustainability and avoid implicit rationing or unaffordable contribution rates. This justifies the use of needs-based evaluation methods by Pareto-superiority and consent. The view of economic evaluation presented here may help account for fairness concerns in the further development of evaluation methods. This is because it directs the attention away from determining some unit of value to be maximized towards determining those persons who are most likely not to consent and meeting their concerns. Following this direction in methods development is likely to increase the acceptability of health economic evaluation by decision makers. (shrink)

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women9s Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial (...) protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. (shrink)

Peer review is a widely accepted instrument for raising the quality of science. Peer review limits the enormous unstructured influx of information and the sheer amount of dubious data, which in its absence would plunge science into chaos. In particular, peer review offers the benefit of eliminating papers that suffer from poor craftsmanship or methodological shortcomings, especially in the experimental sciences. However, we believe that peer review is not always appropriate for the evaluation of controversial hypothetical science. We argue that (...) the process of peer review can be prone to bias towards ideas that affirm the prior convictions of reviewers and against innovation and radical new ideas. Innovative hypotheses are thus highly vulnerable to being “filtered out” or made to accord with conventional wisdom by the peer review process. Consequently, having introduced peer review, the Elsevier journal Medical Hypotheses may be unable to continue its tradition as a radical journal allowing discussion of improbable or unconventional ideas. Hence we conclude by asking the publisher to consider re-introducing the system of editorial review to Medical Hypotheses. (shrink)

© 2015 Elsevier Inc.Postnatal organogenesis occurs in an immune competent environment and is tightly controlled by interplay between positive and negative regulators. Innate immune cells have beneficial roles in postnatal tissue remodeling, but roles for the adaptive immune system are currently unexplored. Here we show that adaptive immune responses participate in the normal postnatal development of a non-lymphoid epithelial tissue. Since the mammary gland is the only organ developing predominantly after birth, we utilized it as a powerful system to study (...) adaptive immune regulation of organogenesis. We found that antigen-mediated interactions between mammary antigen-presenting cells and interferon-γ -producing CD4+ T helper 1 cells participate in MG postnatal organogenesis as negative regulators, locally orchestrating epithelial rearrangement. IFNγ then affects luminal lineage differentiation. This function of adaptive immune responses, regulating normal development, changes the paradigm for studying players of postnatal organogenesis and provides insights into immune surveillance and cancer transformation. Plaks et al. (shrink)

The success of deep brain stimulation (DBS) for movement disorders and the improved understanding of the neurobiologic and neuroanatomic bases of psychiatric diseases have led to proposals to expand current DBS applications. Recent preclinical and clinical work with Alzheimer's disease and obsessive-compulsive disorder, for example, supports the safety of stimulating regions in the hypothalamus and nucleus accumbens in humans. These regions are known to be involved in addiction and overeating associated with obesity. However, the use of DBS targeting these areas (...) as a treatment modality raises common ethical considerations, which include informed consent, coercion, enhancement, threat to personhood, and manipulation of the reward center. Pilot studies for both of these conditions are currently investigational. If these studies show promise, then there is a need to address the ethical concerns related to the initiation of clinical trials including the reliability of preclinical evidence, patient selection, study design, compensation for participation and injury, cost-effectiveness, and the need for long-term follow-up. Multidisciplinary teams are necessary for the ethical execution of such studies. In addition to establishing safety and efficacy, the consideration of these ethical issues is vital to the adoption of DBS as a treatment for these conditions. We offer suggestions about the pursuit of future clinical trials of DBS for the treatment of addiction and overeating associated with obesity and provide a framework for addressing ethical concerns related to treatment. (shrink)

Table of contents for MONSTERS AND PHILOSOPHY, edited by Charles T. Wolfe (London 2005) -/- List of Contributors iii Acknowledgments vii List of Abbreviations ix -/- Introduction xi Charles T. Wolfe The Riddle of the Sphinx: Aristotle, Penelope, and 1 Empedocles Johannes Fritsche Science as a Cure for Fear: The Status of Monsters in 21 Lucretius Morgan Meis Nature and its Monsters During the Renaissance: 37 Montaigne and Vanini Tristan Dagron Conjoined Twins and the Limits of our Reason 61 Annie (...) Bitbol-Hespériès Degeneration and Hybridism in the Early Modern Species 109 Debate: Towards the Philosophical Roots of the Creation-Evolution Controversy Justin E. H. Smith Leibniz on the Unicorn and Various other Curiosities 131 Roger Ariew The Creativity of God and the Order of Nature: 153 Anatomizing Monsters in the Early Eighteenth Century Anita Guerrini The Status of Anomalies in the Philosophy of Diderot 169 Annie Ibrahim The Materialist Denial of Monsters 187 Charles T. Wolfe Cerebral Assymetry, Monstrosities and Hegel. 205 On the Situation of the Life Sciences in 1800 Michael Hagner The Lady Knight of the Perilous Place 217 Elfriede Jelinek Monster: More than a Word. . . From Portent to Anomaly, 231 the Extraordinary Career of Monsters Beate Ochsner Index 281 . (shrink)

In lieu of an abstract, here is a brief excerpt of the content:BOOK REVIEWS 85 scientious search for principles of method (and of peace) may have been one of the reasons why he was suspect in England, as were the Ramist "methodists." In any case, it is quite clear now that Hobbes was not a materialist, not even when he was writing De Corpore. HERBERT W. SCHNEIDER Claremont, CallJornia Pierre Bayle, Historical and Critical Dictionary selections. Translated with an Introduction and (...) notes by Richard H. Popkin. (New York: The Bobbs-Merrill Co. Pp. xliv q- 456.) This new edition of selections from Pierre Bayle's famous Dictionnaire will be welcomed by historians and philosophers alike. In it we find a representative sample from the book that was both the inspiration and despair of much of eighteenth-century thought, and that still presents modem man with both questions and methodological acid that makes it difficult to find or accept "truth." The young readers who will meet Pierre Bayle for the first time in these pages will find him to be the skeptical philosopher, the ribald, sometimes lewd, even pornographic storyteller, the detached scholar who prowled through the history and the ideas of men, dissolving all certainty by analyses that peeled off layer after layer of belief until the core itself was exposed as naive or ridiculous. Had Professor Popkin done nothing more than provide us with these excellently chosen selections from the Dictionnaire, we would all be in his debt, for he gives us a chance easily to bring this important work to the attention of our students. But this volume is considerably more than simply a selection. Professor Popkin's Introduction is an important statement in the controversy over Bayle's personal beliefs and involvemeat. For more than two decades a large literature has portrayed Bayle in many different guises: for some he was still the skeptic who intentionally forged the weapons with which Voltaire and his colleagues assaulted the Judeo-Christian traditions of European men; at the other extreme he was a devout Huguenot who merely wanted to do for the Calvinist world what Bishop Huet and other Catholic skeptics did for the Catholic one, namely to prove the necessity of accepting the Christian beliefs on faith since absolute knowledge was impossible. Professor Popkin has learned Bayle's methodology too well to allow himself to be trapped by a simple explanation. He refuses to identify Bayle with a Kierkegaard or a Lamennais whose ideas would dissolve under Bayle's pen just as did Pascal's and Jurieu's. But where are we to find the secret of this man who lived out his life as a member of the French Reformed Church in Amsterdam while he unfolded the absurdity or naivet~ of every intelligible Christian theology? The problem becomes more perplexing when we note his obvious sympathy for both Manicheanism and Judaism. Could he have been the last of the Cathars or a secretly converted Jew? Popkin calls attention to Bayle's interest in and affection for Maimonides' work which he translates "Guide for the perplexed", but which could be translated "Guide for those who have lost their way" or in our parlance, "the derailed." In a way Bayle's Dictionnaire was itself a "Guide" for men in trouble with their beliefs. But Bayle's approach to this problem must be understood in light of his own discussion of religion "of the heart" and religion "of reason." Like Madame Labrousse, Popkin is much impressed by the simplicity of Bayle's last words, written on the day he died, in which he described himself as "a Christian philosopher convinced of and pierced with the mercies of God.... " The statement omits all the im~ portant theological propositions of Christian theology as well as any emotional feeling. We must see Pierre Bayle as an erudite, unemotional man whose "religion had no expressed or expressible content.., but was only in the heart in some quiet unemotional way.... " Popkin sees him as "a quite Erasmian scholar, living out his days in the city of Erasmus, examining man's intellectual heritage and intellectual world.., by patient erudition [undermining] man's intellectual frame of reference while remaining secure and tranquil in his unemotional religion of the heart." Since... (shrink)

A rupture has occurred–something is no longer quite as it was. Our current environmental crisis, climate catastrophe,has left us floundering without words for after three decades of popular ecological writing and decades more of scientificstudies nothing has yet been done to avert our path from its terminal arc. It is a weird occurrence for our words seeminsufficient, our categories incapacitated, and our understanding too flawed to comprehend it. Yet, it is a disasterwhich has already occurred–it is a disaster which we (...) live in the midst of and yet still lack the language with which tospeak. The greatest danger of such an epoch, according to Blanchot, is that, out of convenience, we use an outdatedand unsuitable language to attempt reconciliation. Rather than attempting to apply logical and nomical systems andconcepts to a catastrophe, which is catastrophic precisely because it obsolesces such ways of thinking, a new mode ofthought, of language, is required if climate catastrophe is to be properly understood and addressed. Utilizing the textsof Roland Barthes, Karen Barad, Maurice Blanchot and Timothy Morton, as well as the weird fiction of H.P.Lovecraft, I intend to demonstrate not only the pitfalls of our current agrilogistical approach to climate catastrophe,but also a potential eco-deconstructive alternative that would allow significant change to occur. (shrink)