Conflicts of interest are common and exist in academia, government, and many industries, including pharmaceutical development. Medical journal editors and others have recently criticized “the pharmaceutical industry,” citing concerns over investigator access to data, approaches to analysis of clinical trial data, and publication practices. Merck & Co., Inc. is a global, research-driven pharmaceutical company that discovers, develops, manufactures, and markets a broad range of human and animal health products, directly and through its joint ventures. Although part of its mission is (...) to provide a superior rate of return to its investors, Merck does not believe this creates an irreconcilable conflict of interest, particularly in activities concerning clinical drug development. We employ rigorous scientific methods to design, conduct, analyze, and report results of clinical trials in the development of innovative drugs and vaccines, with a focus on meeting unmet medical needs and with an ethic that puts the interests of the patient first. This article describes Merck’s approaches to potential conflicts of interest in drug development, particularly with regard to clinical trials. We believe that proprietary interests of the Company can be respected while observing objectivity and transparency in communicating clinical research results. The standards for the review of manuscripts reporting such trials for peer-reviewed publication should be the same, whether they are from Merck or elsewhere. (shrink)

This book updates and adds to the classic Social Movements of the Sixties and Seventies, showing how social movement theory has grown and changed.

With the publication of two books and a series of articles in the late 1960s and 1970s, E. D. Hirsch Jr. established himself as a major voice in the debates about interpretation and literary criticism. Against the mainstream, he proposed and defended an “objectivist” hermeneutics. His voice has remained alive in the debates as the proponent of objectivity in interpretation. As the title of his major book on hermeneutics, Validity in Interpretation (1976), suggests, Hirsch's primary concern is the (...) validation of an interpretation. According to Hirsch, validation is one of two sides of the interpretive process. The first step of any interpretation is guessing at its meaning. Hirsch's genial guess was Schleiermacher's divination. In the course of his discussion of genre, to clarify his view of interpretation, Hirsch mentions Emilio Betti's classification of three types of interpretation: re‐cognitive (historical and literary), presentational (dramatic and musical), and normative (legal and religious). (shrink)

Calls for public engagement on emerging agricultural technologies, including genetic engineering of farm animals, have resulted in the development of information that people can interact and engage with online, including “Frequently Asked Questions” (FAQs) developed by organizations seeking to inform or influence the debate. We conducted a frame analysis of FAQs webpages about genetic engineering of farm animals developed by different organizations to describe how questions and answers are presented. We categorized FAQs as having a regulatory frame (emphasizing or challenging (...) the adequacy of regulations), an efficiency frame (emphasizing precision and benefits), a risks and uncertainty frame (emphasizing unknown outcomes), an animal welfare frame (emphasizing benefits for animals) or an animal dignity frame (considering the inherent value of animals). Animals were often featured as the object of regulations in FAQs, and questions about animals were linked to animal welfare regulations. The public were represented using a variety of terms (public, consumer) and pronouns (I, we). Some FAQs described differences between technology terms (gene editing, genetic modification) and categorized technologies as either well-established or novel. This framing of the technology may not respond to actual public concerns on the topic. Organizations seeking to use FAQs as a public engagement tool might consider including multiple viewpoints and actual questions people have about genetic engineering. (shrink)

The introduction of the Diagnostic and Statistical Manual of Mental Disorders in May 2013 is being hailed as the biggest event in psychiatry in the last 10 years. In this paper I examine three important issues that arise from the new manual: Expanding nosology: Psychiatry has again broadened its nosology to include human experiences not previously under its purview. Consequence-based ethical concerns about this expansion are addressed, along with conceptual concerns about a confusion of "construct validity" and "conceptual validity" and (...) a failure to distinguish between "disorder" and "nondisordered conditions for which we help people." The role of claims about societal impact in changes in nosology: Several changes in the DSM-5 involved claims about societal impact in their rationales. This is due in part to a new online open comment period during DSM development. Examples include advancement of science, greater access to treatment, greater public awareness of condition, loss of identify or harm to those with removed disorders, stigmatization, offensiveness, etc. I identify and evaluate four importantly distinct ways in which claims about societal impact might operate in DSM development. Categorisation nosology to spectrum nosology: The move to "degrees of severity" of mental disorders, a major change for DSM-5, raises concerns about conceptual clarity and uniformity concerning what it means to have a severe form of a disorder, and ethical concerns about communication. (shrink)

The growing literature on how people learn to make decisions based on experience focuses on two types of paradigms. In one paradigm, people are faced with a choice, and must retrospectively consult past experience of similar choices to decide what to do. In the other paradigm, people are faced with a choice, and then have the opportunity prospectively to gather new experiences that might help them make that choice. The current paper examines the joint impact of both retrospective and prospective (...) experiences. Two experiments reveal strong interactions. In Study 1, repeated experience with new samples appears to reduce sensitivity to the average outcome in the samples and enhances underweighting of rare events. Study 2 shows that repeated experience with pre-choice samples can reverse the impact of the new information. The results suggest that prospectively gathering new samples can have two, potentially contrasting, influences on choice: the first focuses on the sample’s face value and selects the option with the higher value in the new sample; by contrast, the second treats the new sample as a cue to recall similar prior experiences, which in turn drive choice. The paper concludes with a discussion of the possibility that part of the descriptive value of prospect theory reflects the fact that it summarizes the joint impact of similar “face-or-cue” processes. (shrink)

Metaphysics has had a long history of debate over its viability, and substantivity. This thesis explores issues connected to the realism question within the domain of metaphysics, ultimately aiming to defend a realist, substantive metaphysics by responding to so-called deflationary approaches, which have become prominent, and well supported within the recent metametaphysical and metaontological literature. To this end, I begin by examining the changing nature of the realism question. I argue that characterising realism and anti-realism through theories of truth unduly (...) places epistemology prior to ontology, and is unwarranted in assuming a non-neutrality between theories of truth and positions within the realism debate. I therefore propose a characterisation of realism and anti-realism understood through truthmaking. This produces a suitable working characterisation of realism that will be used within the remainder of this project. In the second section, I trace the historical influences upon current deflationary approaches to metaphysics, most prominently those of Carnap, and Putnam. I argue that Quine’s supposed attack on Carnap’s anti-metaphysical thought fails, and show how current deflationary thought, most prominently exhibited by Hirsch, came to focus on linguistically derived concerns over the substantivity of metaphysics. In the third section, I outline a number of issues for the deflationist, and defend the coherency and legitimacy of the unrestricted existential quantifier. Focusing on the linguistic aspect of deflationism, I argue that the conception of language that the deflationist relies upon lacks suitable empirical and theoretical support within linguistics and other related domains. Furthermore, I suggest that linguistic analysis in fact supports the claim that the quantifier carries no inherent restrictions. This restores our ability to suitably posit the unrestricted existential quantifier, as a quantifier wherein the domain is only restricted by metaphysically substantive restrictions. Through this, I argue that metaphysics is a substantive domain of discourse. Lastly, I sketch a positive account of how, under an empirically and theoretically justified conception of language, metaphysics can be coherently held to be a realist, substantive enterprise, contra claims that hold that the nature of language inherently prevents metaphysics being considered to be a substantive domain of discourse. (shrink)

This paper analyzes the work of Emmanuel Levinas and René Girard and argues that both of them have as their central problem the phenomenon of human violence and both try to address this problem from their own religious tradition, Jewish for Levinas, Christian for Girard. They both pursue the concept of nonviolence to an extreme point in what each calls saintliness or holiness and both can be considered religious prophets of this extreme version of nonviolence.