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)

Rising energy costs, increasing herd sizes, and other structural changes affecting the New York dairy industry may make farmers receptive to new energy production technologies. Anaerobic digestion represents a possible benefit to farmers by reducing odor while producing methane for electricity. However, current digester designs are for herd sizes of 300 or more cows, with significant economies of scale, so smaller operators may have little interest in the technology. Moreover, without a favorable policy environment and reliable grant programs, the initial (...) investments required for digester installation might deter operators. One solution to these issues may be community digesters, which are centrally located facilities that accept manure from multiple farms. Data from a survey of New York dairy farmers were used to assess farmers’ interest in community digesters. In general, interest was associated with power generation outcomes and reservations about organic farming practices; advocates might encourage their use among smaller conventional farm operators looking for new sources of profit and diversification. (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)

Cognitive Science, Volume 46, Issue 6, June 2022.

Alexander W. Hall - Demonstration and Scientific Knowledge in William of Ockham: A Translation of Summa Logicae III-II: De Syllogismo Demonstrativo, and Selections from the Prologue to the Ordinatio - Journal of the History of Philosophy 46:1 Journal of the History of Philosophy 46.1 170-172 Muse Search Journals This Journal Contents Reviewed by Alexander W. Hall Clayton State University John Lee Longeway, translator. Demonstration and Scientific Knowledge in William of Ockham: A Translation of Summa Logicae III–II: De Syllogismo (...) Demonstrativo, and Selections from the Prologue to the Ordinatio. Notre Dame, IN: University of Notre Dame Press, 2007. Pp. xx + 432. Cloth, $58.00. William of Ockham never delivered his promised exposition of Posterior Analytics. In its place, we have Summa Logicae III–II, and the Prologue to his Ordinatio... (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)

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

Although a great deal has been written concerning the verifiability of empirical, declarative sentences, yet some further clarification in this area seems possible and desirable. I think it is important to determine what sort of property ‘verified by’ is. Obviously it is a semiotical property. Only sentences, never matters of fact, are verified. But where, in the area of semiotics, is it to be placed? To use Charles Morris's useful and now somewhat traditional classification, is it a syntactic, semantic, or (...) pragmatic predicate? My answer is that it falls within semantics. Before developing this, however, I should like to point out why I do not place it in either of the other two subdivisions. (shrink)

A recent study contends that for Plato, the state, including the ideal state of the Republic, is better governed by unfettered personal authority than by law. The present study maintains that even in the Republic and the Statesman, as well as in the Laws, it is law, not unfettered personal rule that underlies the state. Justification for such authoritarian rule, especially in the ideal state of the Republic, lies in the supposed inability of the ordinary individual to acquire moral autonomy (...) or Platonic justice owing to a lack of the necessary knowledge. But it is shown in this study that the ordinary individual of the ideal state can acquire an educated right opinion sufficient for gaining moral autonomy or Platonic justice. (shrink)

The concepts of joint probability as implied by the Copenhagen and realist interpretations of quantum mechanics are examined in relation to (a) the rules for manipulation of probabilistic quantities, and (b) the role of the Bell inequalities in assessing the completeness of standard quantum theory. Proponents of completeness of the Copenhagen interpretation are required to accept a modification of the classical laws of probability to provide a mechanism for complementarity. A new formulation of the locality postulate is given, not involving (...) factorizability or conditional probabilities, which clarifies the role of locality in the derivation of the Bell inequalities. (shrink)

MS. 124 in the library of St. John Baptist College, Oxford, is a quarto of 154 pages, written in two or more hands of the fifteenth century. Its provenance is unknown, and, as it has been carefully and ruthlessly rebound at some time in the nineteenth century, it is impossible to derive any information from the binding. After an unusually elabbrate alphabetical index it bears on folio 11 an inscription in a seventeenth-century hand as follows: ‘Libellus Thomae de Walsingham De (...) generacione naturaque deorum simul cum interpretatione Ouidii Metamorphoseon Simoni Priori Sancti Albani dedicatus.’. (shrink)