This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes (...) oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight. (shrink)

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Throughout, assessments employing both the multiple criteria and a method of expert elicitation are combined with the existing literature, case law, and regulations providing an integrative historical case study approach. The goal is to provide useful information from multiple disciplines and perspectives to (...) guide discussions regarding appropriate oversight frameworks for nanobiotechnology applications under the FDA’s purview. (shrink)

This book explores aspects of William H. Poteat's philosophical anthropology, which proposes a post-critical alternative to the prevailing dualistic conception of the person and opens a path to recovery of the pre-reflective ontological ground of the person where our personhood can be recovered and re-appropriated.

Conspiracy theories (CTs) are widespread ways by which people make sense of unsettling or disturbing cultural events. Belief in CTs is often connected to problematic consequences, such as decreased engagement with conventional political action or even political extremism, so understanding the psychological and social qualities of CTs belief is important. CTs have often been understood to be “monological”, displaying the tendency for belief in one conspiracy theory to be correlated with belief in (many) others. Explanations of monologicality invoke a nomothetical (...) or “closed” mindset whereby mutually supporting beliefs based on mistrust of official explanations are used to interpret public events as conspiracies, independent of the facts about those events (which they may ignore or deny). But research on monologicality offers little discussion of the content of monological beliefs and reasoning from the standpoint of the CT believers. This is due in part to the “access problem” (Wood & Douglas, 2015): CT believers are averse to being researched because they often distrust researchers and what they appear to represent. We used several strategies to address the access problem, and investigated the symbolic resources underlying CTs by reconstructing a conspiracy worldview - a set of beliefs held by CT believers about important dimensions of ontology, epistemology, and human agency. To do this, we analysed media documents, conducted field observation, and engaged in semi-structured interviews,. We describe six main dimensions of a conspiracy worldview: Views of the nature of reality, the self, the outgroup, the ingroup, action, and the future. We also describe a typology of five types of CT believers, which vary according to their positions on each of these dimensions. Our findings converge with prior explorations of CT beliefs but also revealed novel aspects: A sense of community among CT believers, a highly differentiated representation of the outgroup, a personal journey of conversion, variegated kinds of political action, and optimistic belief in future change. These findings are at odds with the typical image of monological CT believers as paranoid, cynical, anomic and irrational. For many, the CT worldview may rather constitute the ideological underpinning of a nascent pre-figurative social movement. (shrink)

Nanotechnology, as with many technologies before it, places a strain on existing legislation and poses a challenge to all administrative agencies tasked with regulating technology-based products. It is easy to see how statutory schemes become outdated, as our ability to understand and affect the world progresses. In this article, we address the regulatory problems that nanotechnology posses for the Food and Drug Administration’s (FDA) classification structure for ‘‘drugs’’ and ‘‘devices.’’ The last major modification to these terms was in 1976, with (...) the enactment of the Medical Device Amendments. There are serious practical differences for a classification as a drug or device in terms of time to market and research. Drugs are classified, primarily, as acting by ‘‘chemical action.’’ We lay out some legal, philosophic, and scientific tools that serve to provide a useful, as well as legally and scientifically faithful, distinction between drugs and devices for the purpose of regulatory classification. These issues we raise are worth the consideration of anyone who is interested in the regulation of nano-products or other novel technologies. (shrink)

A “cocaine vaccine” is a promising immunotherapeutic approach to treating cocaine dependence which induces the immune system to form antibodies that prevent cocaine from crossing the blood brain barrier to act on receptor sites in the brain. Studies in rats show that cocaine antibodies block cocaine from reaching the brain and prevent the reinstatement of cocaine self administration. A successful phase 1 trial of a human cocaine vaccine has been reported. The most promising application of a cocaine vaccine is to (...) prevent relapse to dependence in abstinent users who voluntarily enter treatment. Any use of a vaccine to treat cocaine addicts under legal coercion raises major ethical issues. If this is done at all, it should be carefully trialled first, and only after considerable clinical experience has been obtained in using the vaccine to treat voluntary patients. There will need to be an informed community debate about what role, if any, a cocaine vaccine may have as a way of preventing cocaine addiction in children and adolescents. (shrink)

At the request of the Classical Journals Board we have undertaken for the present to edit this Journal. In so doing we confidently rely upon the co-operation of those who have hitherto been contributors, as well as of others who may be in a position to assist us.

Here, some of the most influential thinkers in theological and philosophical ethics develop new directions for research in contemporary moral thought. Taking as their starting point Ricoeur's recent work on moral anthropology, the contributors set a vital agenda for future conversations about ethics and just community.

I IN WHAT SENSE CAN VALUE BE ANALYSED? THE present essay is meant to be an instance of philosophical analysis. ...

Machine generated contents note: Introduction Henry Somers-Hall; 1. Deleuze and the history of philosophy Daniel W. Smith; 2. Difference and repetition James Williams; 3. The Deleuzian reversal of Platonism Miguel Beistegui; 4. Deleuze and Kant Beth Lord; 5. Phenomenology and metaphysics, and chaos: on the fragility of the event in Deleuze Leonard Lawlor; 6. Deleuze and structuralism François Dosse; 7. Deleuze and Guattari: Guattareuze and Co. Gary Genosko; 8. Nomadic ethics Rosi Braidotti; 9. Deleuze's political philosophy Paul Patton; 10. (...) Deleuze, mathematics, and realist ontology Manuel Delanda; 11. Deleuze and life John Protevi; 12. Gilles Deleuze's aesthetics of sensation Dorothea Olkowski; 13. Deleuze and literature Ronald Bogue; 14. Deleuze and psychoanalysis Eugene Holland; 15. Deleuze's philosophical heritage: unity, difference, and onto-theology Henry Somers-Hall. (shrink)