Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms (...) enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee. Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice. (shrink)
The distinction between germline and somatic gene editing is fundamental to the ethics of human gene editing. Multiple conferences of scientists, ethicists, and policymakers, and multiple professional bodies, have called for moratoria on germline gene editing, and editing of human germline cells is considered to be an ethical “red line” that either never should be crossed, or should only be crossed with great caution and care. However, as research on germline gene editing has progressed, it has become clear that not (...) all germline interventions are alike, and that these differences make a significant moral difference, when it comes to ethical questions about research, regulation, clinical application, and medical justification. In this paper, I argue that, rather than lumping all germline interventions together, we should distinguish between revising, correcting, and transferring genes, and I assess the consequences of this move for the ethics of gene editing. (shrink)
Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerning intergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational monitoring. The aim (...) of this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued. (shrink)
:Since the advent of recombinant DNA technology, expectations about the potential for altering genes and controlling our biology at the fundamental level have been sky high. These expectations have gone largely unfulfilled. But though the dream of being able to control our biology is still far off, gene editing research has made enormous strides toward potential clinical use. This paper argues that when it comes to determining permissible uses of gene editing in one important medical context—germline intervention in reproductive medicine—issues (...) about enhancement and eugenics are, for the foreseeable future, a red herring. Current translational goals for gene editing research involve a different kind of editing than would be required to achieve manipulation of complex traits such as intelligence, and there are more pressing questions that need attention if clinical use of gene editing in reproductive medicine ever becomes a possibility. (shrink)
In debates about the moral foundations of intellectual property, one very popular strand concerns the role of labor as a moral basis for intellectual property rights. This idea has a great deal of intuitive plausibility; but is there a way to make it philosophically precise? That is, does labor provide strong reasons to grant intellectual property rights to intellectual laborers? In this paper, I argue that the answer to that question is “yes”. I offer a new view, different from existing (...) labor theories of intellectual property, which I call the productive capacities view. This view gives us a way to make sense of the idea of labor as the basis for intellectual property rights, as well as a tool for critically evaluating existing intellectual property institutions. (shrink)
When developing computational models to analyze the tradeoffs between climate risk management strategies (i.e., mitigation, adaptation, or geoengineering), scientists make explicit and implicit decisions that are influenced by their beliefs, values and preferences. Model descriptions typically include only the explicit decisions and are silent on value judgments that may explain these decisions. Eliciting scientists’ mental models, a systematic approach to determining how they think about climate risk management, can help to gain a clearer understanding of their modeling decisions. In order (...) to identify and represent the role of values, beliefs and preferences on decisions, we used an augmented mental models research approach, namely values-informed mental models (ViMM). We conducted and qualitatively analyzed interviews with eleven climate risk management scientists. Our results suggest that these scientists use a similar decision framework to each other to think about modeling climate risk management tradeoffs, including eight specific decisions ranging from defining the model objectives to evaluating the model’s results. The influence of values on these decisions varied between our scientists and between the specific decisions. For instance, scientists invoked ethical values (e.g., concerns about human welfare) when defining objectives, but epistemic values (e.g., concerns about model consistency) were more influential when evaluating model results. ViMM can (i) enable insights that can inform the design of new computational models and (ii) make value judgments explicit and more inclusive of relevant values. This transparency can help model users to better discern the relevance of model results to their own decision framing and concerns. (shrink)
Valerie Tiberius’s Moral Psychology: An Introduction is a gem. Clearly and crisply drawing on empirical and non-empirical work in philosophy and psychology, Tiberius illuminates the many ways in which the issues central to moral psychology arise in and bear on normative ethics, meta-ethics, and the study of agency and responsibility. Tiberius articulates deep debates, complex concepts and rationales, intricate empirical data points, and obscure assumptions with an enviable ease. Further, though the book is pitched in a manner that is (...) accessible to novices, it offers experts an opportunity to see their discipline through a very informed and distinctive lens. In particular, Tiberius imparts a rich and robust picture of value theory that can overlay the expert’s own and thereby enrich the concerns and problems that make up its subject matter. I hope that through this review I can add to the book’s excellence in two ways.First, one of the most helpful things to appear in the book are its g .. (shrink)
Valerie Steele, conservatrice du musée du Fashion Institute of Technology de New York et rédactrice en chef d'une revue de grande qualité, Fashion Theory : the journal of Dress, Body and Culture, est une référence très importante dans le domaine de l'histoire de la mode. Ce livre (traduit de l'américain) ne répond que très imparfaitement à son titre ambitieux « se vêtir » , qui est aussi celui d'une collection (deux ouvrages déjà parus, l'un sur le Moyen Âge (...) et l'autre sur le XVIIIe.. (shrink)
Depuis les travaux pionniers des années 1970, les domestiques étaient restés en marge des problématiques de l'histoire du travail et de l'histoire des femmes. Et pourtant, l'évolution de la condition ancillaire décline un ensemble de questions essentielles à la compréhension du tissu social et de la place des femmes sur le marché du travail. La recherche de Valérie Piette sur la Belgique du XIXe siècle en est une brillante démonstration. Elle repose sur une exploration méthodique des ..
L’ouvrage que publie Valérie Beaudouin, tiré de sa thèse soutenue en 2000, se signale par de nombreuses qualités, parmi lesquelles on distinguera l’ampleur de la matière étudiée, l’originalité de la démarche et des méthodes, l’intérêt neuf et majeur de maints résultats, le renouvellement méthodologique qu’il apporte dans le domaine de la métrique française. L’auteur s’est proposé de décrire le vers du théâtre classique, en s’appuyant sur un corpus constitué de la totalité des pièces de Cornei..
It's very interesting to see neurophysiological evidence brought to bear on the puzzling question of conscious experience. Many have observed that information-processing models of cognition seem to leave consciousness untouched; it is natural to hope that turning to neurophysiology might lead us to the Holy Grail. Still, I think there are reasons to be skeptical. There are good reasons to suppose that neurophysiological investigation contributes to cognitive explanation at best in virtue of constraining the information-processing structure of cognition. Of course (...) this is a very large and significant role for it to play, but it may be over-optimistic to suppose that it can play some further explanatory role, taking us where information-processing theories cannot. If so, then neurophysiological accounts will be no more and no less successful at dealing with consciousness than information-processing accounts are. (shrink)
Dans le monde philosophique anglophone, Elizabeth Anscombe fait déjà partie des références incontournables. Son nom est généralement associé à celui de Wittgenstein dont elle fut l’un des principaux éditeurs et traducteurs. Mais elle est aussi l’auteure reconnue de deux contributions majeures : Intention , à l’origine du renouveau contemporain de la philosophie de l’action, et « Modern moral philosophy » , qui ouvrit la voie au retour de l’éthique des vertus. La philos..