Selective reporting is prevalent in the medical literature, particularly in industry-sponsored research. In this paper, we expose selective reporting that is not evident without access to internal company documents. The published report of study 329 of paroxetine in adolescents sponsored by GlaxoSmithKline claims that “paroxetine is generally well tolerated and effective for major depression in adolescents”. By contrast, documents obtained during litigation reveal that study 329 was negative for efficacy on all 8 protocol specified outcomes and positive for harm.

Despite popular representations to the contrary, creative people are rarely insane. But creativity and madness may be connected in other ways; we find suggestions of schizotypy in the biographies of many artists, and schizophrenia and related conditions seem to be disproportionately represented in talented and creative families. There are attractions, therefore, in the idea that creativity depends on the controlled deployment of capacities that are uncontrolled in psychosis: an idea explored by psychoanalytically inclined writers such as Ernst Kris and Hanna (...) Segal. (shrink)

The lingering controversy concerning the usefulness and safety of antidepressants for children and adolescents is likely to confuse clinicians. Recent papers perpetuate the claim that antidepressants are shown to be safe and effective in randomised controlled trials. Others claim that antidepressants have been shown to prevent suicides. In this editorial we address the manipulation of outcomes that result from academics’ alliance with industry. We explain how industry and key opinion leaders have distorted the clinician’s perception of the safety and usefulness (...) of antidepressants for the treatment of depression in children and adolescents through publication bias, poor methodology, and selective reporting. (shrink)

We outline a theory of one puzzling aspect of human cognition: a tendency to exaggerate the degree to which agency is manifested in the world. We call this over‐coherent thinking. We use Pylyshyn's idea of cognitive penetrability to help characterize this notion. We argue that this kind of thinking is essentially narrative in form rather than theoretical. We develop a theory of the relation between the degree of narrativity in a representation and its aptness to represent, and to express, mind. (...) We review the prospects for several theories about how over‐coherent thinking gains a purchase on motivation. We argue that progress in this difficult area may require the abandonment of a categorical belief/imagination distinction in favour of vaguely specified clusterings in a many‐dimensional cognitive space. We conclude with the idea that an error‐prone system for the retention of ideas that are low in some of the characteristics generally thought desirable in belief might emerge as a result of an arms‐race between deceivers and deceiver‐detectors. (shrink)

In recent years, a number of contemporary proponents of psychoanalysis have sought to derive support for their conjectures about the _dynamic_ unconscious from the empirical evidence in favor of the _cognitive_ unconscious. It is our contention, however, that far from supporting the dynamic unconscious, recent work in cognitive science suggests that the time has come to dispense with this concept altogether. In this paper we defend this claim in two ways. First, we argue that any attempt to shore up the (...) dynamic unconscious with the cognitive unconscious is bound to fail, simply because the latter, as it is understood in contemporary cognitive science, is incompatible with the former, as it is traditionally conceived by psychoanalytic theory. Second, we show how psychological phenomena traditionally cited as evidence for the operation of a dynamic unconscious can be accommodated more parsimoniously by other means. (shrink)

© 2003 by The Johns Hopkins University Press.

In this case study from litigation, we show how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication. Study 329 for paroxetine pediatric use was negative for efficacy and positive for harm. Yet the ghostwritten publication from this study concluded that paroxetine provided evidence of efficacy and safety and continues to be influential. Despite the role of named authors in revisions of the manuscript, the sponsor company remained in control of the message.

This paper is a deconstruction of a ghostwritten report of a randomized, double-blind, placebo-controlled efficacy and safety trial of citalopram in depressed children and adolescents conducted in the United States. Court documents revealed that protocol-specified outcome measures showed no statistically significant difference between citalopram and placebo. However, the published article concluded that citalopram was safe and significantly more efficacious than placebo for children and adolescents, with possible adverse effects on patient safety.

We live in an age alleged devoted to evidence-based medicine. Evidence-based medicine, however, depends on reliable data and if the data are largely, if not completely, manipulated by the manufacturer of pharmaceuticals, then the data are not reliable. Evidence-based medicine is an illusion. This book raises and attempts to answer the following questions: What are the ways in which the profit motive of industry undermines the integrity of science? How is science protected from corporate malfeasance in a capitalist economy? Our (...) particular focus is the relationship between the pharmaceutical industry and medicine. We argue that medicine desperately needs to re-evaluate its relationship with the pharmaceutical industry and re-affirm the ideal of evidence-based medicine. In our view, Karl Popper’s philosophy of science, Falsificationism and Critical Rationalism, provides a rigorous conception of science required to preserve the integrity of the scientific basis of medicine against the commercial influences. (shrink)

Corporate interests corrupt clinical trials, physicians and universities, undermining the foundation of evidence-based medicine. Philosopher Leemon McHenry and psychiatrist Jon Jureidini argue that the principles underlying Popper’s philosophy of science can protect clinical research from corporate malfeasance in a capitalist economy. -/- Evidence-based medicine was a paradigm shift that is often praised as one of the greatest achievements of medicine in the twentieth century. This radical change in medical practice is based on epistemological hierarchies of evidence, from opinions of (...) respected authorities, mechanistic reasoning and reports of expert committees at the bottom to various levels of observational studies and finally to randomized, placebo-controlled clinical trials at the apex. Randomized, placebo-controlled clinical trials, recognized as the gold standard of clinical experimentation, generally maintain their position in the hierarchies because when well-designed and well-conducted, they provide a basis for assessing harms and benefits, and help deter extravagant claims of efficacy and safety. (shrink)

Journals are failing in their obligation to ensure that research is fairly represented to their readers, and must act decisively to retract fraudulent publications. Recent case reports have exposed how marketing objectives usurped scientific testing and compromised the credibility of academic medicine. But scant attention has been given to the role that journals play in this process, especially when evidence of research fraud fails to elicit corrective measures. Our experience with The Journal of the American Academy of Child and Adolescent (...) Psychiatry (JAACAP) illustrates the nature of the problem. The now-infamous Study 329 of paroxetine in adolescent depression was negative for efficacy on all eight protocol-specified outcomes and positive for harm, but JAACAP published a report of this study that concluded that “paroxetine is generally well tolerated and effective for major depression in adolescents.” The journal’s editors not only failed to exercise critical judgment in accepting the paper, but when shown evidence that the paper misrepresented the science, refused either to convey this information to the medical community or to retract the article. (shrink)

The goal of this paper is to expose the research misconduct of pharmaceutical industry-sponsored clinical trials via three short case studies of corrupted psychiatric trials that were conducted in the United States. We discuss the common elements that enable the misrepresentation of clinical trial results including ghostwriting for medical journals, the role of key opinion leaders as co-conspirators with the pharmaceutical industry and the complicity of top medical journals in failing to uphold standards of science and peer review. We conclude (...) that the corruption of industry-sponsored clinical trials is one of the major obstacles facing evidence-based medicine. (shrink)

A task force of pharmaceutical industry employees and medical journal editors propose ten recommendations to address the problem of erosion of confidence in reporting industry-sponsored clinical trial results. These recommendations do not solve the fundamental problem of industry-sponsored biomedical research. A radical solution is required that severs the relationship between the industry and the journals and restores the integrity of the medical literature.

Scientific and ethical misconduct has increased at an alarming rate as a result of the privatization of knowledge. What began as an effort to stimulate entrepreneurship and increase discovery in biomedical research by strengthening the ties between industry and academics has led to an erosion of confidence in the reporting of research results. Inherent tensions between profit-directed inquiry and knowledge-directed inquiry are instantiated in psychopharmacology, especially in the co-option of academic activity to corporate objectives. The effects of these tensions are (...) visible in research agendas, publication practices, postgraduate education, academic-industry partnerships and product promotion. (shrink)

The advent of evidence-based medicine was a paradigm shift intended to provide a solid scientific foundation for medicine. The validity of this paradigm, however, depends on reliable data from clinical trials, mostly conducted by the pharmaceutical industry and reported in the names of senior academics. The release of previously confidential pharmaceutical industry documents into the public domain has given the medical community valuable insight into the degree to which industry-sponsored clinical trials are manipulated and misrepresented. Until this problem is corrected, (...) evidence-based medicine is an illusion. (shrink)

This chapter presents an overview of the major interpretations of probability followed by an outline of the objective Bayesian interpretation and a discussion of the key challenges it faces. I discuss the ramifications of interpretations of probability and objective Bayesianism for the philosophy of mathematics in general.

Modern philosophy recognizes two major ethical theories: deontology, which encourages adherence to rules and fulfillment of duties or obligations; and consequentialism, which evaluates morally significant actions strictly on the basis of their actual or anticipated outcomes. Both involve the systematic application of universal abstract principles, reflecting the culturally dominant paradigm of technical rationality. Professional societies promulgate codes of ethics with which engineers are expected to comply, while courts and the public generally assign liability to engineers primarily in accordance with the (...) results of their work, whether intended or unintended. A third option, prominent in ancient philosophy, has reemerged recently: virtue ethics, which recognizes that sensitivity to context and practical judgment are indispensable in particular concrete situations, and therefore rightly focuses on the person who acts, rather than the action itself. Beneficial character traits—i.e., virtues—are identified within a specific social practice in light of the internal goods that are unique to it. This paper proposes a comprehensive framework for implementing virtue ethics within engineering. (shrink)

In this volume a diverse group of economists, philosophers, political scientists, and psychologists address the problems, principles, and practices involved in comparing the well-being of different individuals. A series of questions lie at the heart of this investigation: What is the relevant concept of well-being for the purposes of comparison? How could the comparisons be carried out for policy purposes? How are such comparisons made now? How do the difficulties involved in these comparisons affect the status of utilitarian theories? This (...) collection constitutes the most advanced and comprehensive treatment of one of the cardinal issues in social theory. (shrink)

The Problem of Iterated Ground is to explain what grounds truths about ground: if Γ grounds φ, what grounds that Γ grounds φ? This paper develops a novel solution to this problem. The basic idea is to connect ground to explanatory arguments. By developing a rigorous account of explanatory arguments we can equip operators for factive and non-factive ground with natural introduction and elimination rules. A satisfactory account of iterated ground falls directly out of the resulting logic: non- factive grounding (...) claims, if true, are zero-grounded in the sense of Fine. (shrink)

In this paper, I link philosophical discussion of policies for trans inclusion or exclusion, to a method of policy making. I address the relationship between concerns about safety, fairness, and inclusion in policy making about the inclusion of transwomen athletes into women’s sport. I argue for an approach based on lexical priority rather than simple ‘balancing’, considering the different values in a specific order. I present justifying reasons for this approach and this lexical order, based on the special obligations of (...) International Federations such as World Rugby. As a result, I provide a justificatory framework for the WR Guidelines that exclude transwomen from the women’s game in WR competitions. Finally, I give an account of a maximally safe, maximally fair and maximally inclusive form of sex categorisation in sport. (shrink)

I discuss three recent counterexamples to the transitivity of grounding due to Jonathan Schaffer. I argue that the counterexamples don’t work and draw some conclusions about the relationship between grounding and explanation.

Migration and Islamic Ethics, Issues of Residence, Naturalization and Citizenship addresses how Islamic ethical and legal traditions can contribute to current global debates on migration and displacement; how Islamic ethics of muʼakha, ḍiyāfa, ijāra, amān, jiwār, sutra, kafāla, among others, may provide common ethical grounds for a new paradigm of social and political virtues applicable to all humanity, not only Muslims. The present volume more broadly defines the Islamic tradition to cover not only theology but also to encompass ethics, customs (...) and social norms, as well as modern political, humanitarian and rights discourses. The first section addresses theorizations and conceptualizations using contemporary Islamic examples, mainly in the treatment of asylum-seekers and refugees; the second, contains empirical analyses of contemporary case studies; the third provides historical accounts of Muslim migratory experiences. (shrink)

Most authors on metaphysical grounding have taken full grounding to be an internal relation in the sense that it's necessary that if the grounds and the grounded both obtain, then the grounds ground the grounded. The negative part of this essay exploits empirical and provably nonparadoxical self-reference to prove conclusively that even immediate full grounding isn't an internal relation in this sense. The positive, second part of this essay uses the notion of a “completely satisfactory explanation” to shed light on (...) the logic of ground in the presence of self-reference. This allows us to develop a satisfactory logic of ground and recover a sense in which grounding is still an internal relation. (shrink)

Language maps signals onto meanings through the use of two distinct types of structure. First, the space of meanings is discretized into categories that are shared by all users of the language. Second, the signals employed by the language are compositional: The meaning of the whole is a function of its parts and the way in which those parts are combined. In three iterated learning experiments using a vast, continuous, open-ended meaning space, we explore the conditions under which both structured (...) categories and structured signals emerge ex nihilo. While previous experiments have been limited to either categorical structure in meanings or compositional structure in signals, these experiments demonstrate that when the meaning space lacks clear preexisting boundaries, more subtle morphological structure that lacks straightforward compositionality—as found in natural languages—may evolve as a solution to joint pressures from learning and communication. (shrink)

Campaigning activities of non-governmental organisations (NGOs) have increased public awareness and concern regarding the alleged unethical and environmentally damaging practices of many major multinational companies. Companies have responded by developing corporate social responsibility strategies to demonstrate their commitment to both the societies within which they function and to the protection of the natural environment. This has often involved a move towards greater transparency in company practice and a desire to engage with stakeholders, often including many of the campaign organisations that (...) have been at the forefront of the criticisms of their activity. This article examines the ways in which stakeholder dialogue has impacted upon the relationships between NGOs and businesses. In doing so, it contributes to the call for more ‘stakeholder-focused’ research in this field (Frooman in Acad Manag Rev 24(2): 191–205, 1999; Steurer in Bus Strategy Environ 15: 15–69 2006). By adopting a stakeholder lens, and focusing more heavily upon the impact on one particular stakeholder community (NGOs) and looking in depth at one form of engagement (stakeholder dialogue), this article examines how experiences of dialogue are strategically transforming interactions between businesses and NGOs. It shows how experiences of stakeholder dialogue have led to transformations in the drivers for engagement, transformations in the processes of engagement and transformations in the terms of engagement. Examining these areas of transformation, the article argues, reveals the interactions at play in framing and shaping the evolving relationships between business and its stakeholders. (shrink)

Two different versions of the ending of the first additament to C. S. Peirce's 1908 article, "A Neglected Argument for the Reality of God," appear in the Collected Papers but were omitted from The Essential Peirce. In one, he linked the hypothesis of God's Reality to his entire theory of logic as semeiotic, claiming that proving the latter would also prove the former. In the other, he offered a final outline of his cosmology, in which the Reality of God as (...) Ens necessarium is indispensable to both the origin and order of our existing universe of Signs. Exploring these passages, as well as the unpublished manuscript drafts of the article, provides important insights into the key concepts of instinct and continuity within Peirce's comprehensive system of thought. (shrink)

This article presents a critical examination of the process of stakeholder dialogue in the Corporate Social Responsibility (CSR) field. It utilises data from a three-year research project into stakeholder dialogue processes to discuss three central themes: first, what is meant by the term ‘dialogue’, both from a theoretical perspective and from its practical application within CSR; second, the challenges of creating effective dialogue; and third, measuring and assessing the potential outcomes of dialogue. In providing a critical overview of these themes, (...) the article examines the nature of organisational learning through stakeholder engagement and dialogue. It questions the motives behind engagement in dialogue and highlights some of the potential challenges for organisational learning posed by opting for a stakeholder dialogue approach. It argues that organisations engaging in stakeholder dialogue must have a clear understanding of the implications of undertaking a dialogue process and have a long-term perspective regarding the outcomes and learning likely to emerge from it. While stakeholder dialogue may produce significant results, it is argued, many of these may be difficult to quantify on a short-term basis. (shrink)

This article presents a critical examination of the process of stakeholder dialogue in the Corporate Social Responsibility (CSR) field. It utilises data from a three-year research project into stakeholder dialogue processes to discuss three central themes: first, what is meant by the term ‘dialogue’, both from a theoretical perspective and from its practical application within CSR; second, the challenges of creating effective dialogue; and third, measuring and assessing the potential outcomes of dialogue. In providing a critical overview of these themes, (...) the article examines the nature of organisational learning through stakeholder engagement and dialogue. It questions the motives behind engagement in dialogue and highlights some of the potential challenges for organisational learning posed by opting for a stakeholder dialogue approach. It argues that organisations engaging in stakeholder dialogue must have a clear understanding of the implications of undertaking a dialogue process and have a long-term perspective regarding the outcomes and learning likely to emerge from it. While stakeholder dialogue may produce significant results, it is argued, many of these may be difficult to quantify on a short-term basis. (shrink)

I systematically defend a novel account of the grounds for identity and distinctness facts: they are all uniquely zero‐grounded. First, this Null Account is shown to avoid a range of problems facing other accounts: a relation satisfying the Null Account would be an excellent candidate for being the identity relation. Second, a plenitudinist view of relations suggests that there is such a relation. To flesh out this plenitudinist view I sketch a novel framework for expressing real definitions, use this framework (...) to give a definition of identity, and show how the central features of the identity relation can be deduced from this definition. (shrink)

The detailed analysis of a particular quasi-historical numerical example is used to illustrate the way in which a Bayesian personalist approach to scientific inference resolves the Duhemian problem of which of a conjunction of hypotheses to reject when they jointly yield a prediction which is refuted. Numbers intended to be approximately historically accurate for my example show, in agreement with the views of Lakatos, that a refutation need have astonishingly little effect on a scientist's confidence in the ‘hard core’ of (...) a successful research programme even when a comparable confirmation would greatly enhance that confidence. Timeo Danaos et dona ferentis. (shrink)

In this paper I discuss a new conception that has arrived relatively recently on the scene, in the context of the debate over the inclusion of transwomen (hereafter TW) in female sport. That conception is ‘Meaningful Competition’ (hereafter MC) – a term used by some of those who advocate for the inclusion of TW in female sport if and only if they reduce their testosterone levels. I will argue that MC is not fair. I understand MC as a substitute concept, (...) as an attempt to substitute for the perfectly serviceable concept of fair competition. It is an attempt at conceptual engineering that should be resisted. This is important because some International Federations have accepted MC as good coin, and the underlying theory of MC, which I explicate for the first time, underpins the stance taken by the IOC (International Olympic Committee) in its Framework Document. To establish that the inclusion of TW in female sport meets the criteria of MC in the sense I explicate here, does not show that the inclusion of TW in female sport is fair. Such inclusion is not fair, and the proper currency of sport is fair competition. ‘Meaningful Competition’, on the other hand, is a snare and a delusion. (shrink)

The representation of Neg-Raising in the grammar is a matter of controversy. I provide evidence for representing Neg-Raising as a kind of presupposition associated with certain predicates by providing a detailed analysis of NPI-licensing in Neg-Raising contexts. Specific features of presupposition projection are used to explain the licensing of strict NPIs under Neg-Raising predicates. Discussion centers around the analysis of a licensing asymmetry noted in Horn (1971, Negative transportation: Unsafe at any speed? In CLS 7 (pp. 120–133)).Having provided this analysis, (...) I go on to discuss its implications for the theory of NPI-licensing more generally. In particular, I discuss how the present proposal reflects on von Fintel’s (1999, Journal of Semantics, 16, 97–148) proposal to use Strawson downward entailment in the statement of NPI-licensing principles. (shrink)

This paper proposes that both weak and strong NPIs in English are sensitive to the downward entailingness of their licensers. It is also proposed, however, that these two types of NPIs pay attention to different aspects of the meaning of their environment. As observed by von Fintel and Chierchia, weak NPIs do not attend to the scalar implicatures of presuppositions of their licensers. Strong NPIs see both the truth-conditional and non-truth-conditional (scalar implications, presuppositions) meaning of their licensers. This theory accounts (...) for the puzzling inability, noted by Rullmann and Gajewski, of Strawson anti-additive operators to license strong NPIs, as well as for the effects of Zwarts’s hierarchy of negative strength. Additional issues concerning comparative quantifiers, few, and proportional quantifiers are addressed. (shrink)

This paper evaluates the proof-theoretic definition of ground developed by Poggiolesi in a range of recent publications and argues that her proposed definition fails. The paper then outlines an alternative approach where logical consequence relations and the logical operations are defined in terms of ground.

A logic of grounding where what is grounded can be a collection of truths is a “many-many” logic of ground. The idea that grounding might be irreducibly many-many has recently been suggested by Dasgupta. In this paper I present a range of novel philosophical and logical reasons for being interested in many-many logics of ground. I then show how Fine’s State-Space semantics for the Pure Logic of Ground can be extended to the many-many case, giving rise to the Pure Logic (...) of Many-Many Ground. In the second, more technical, part of the paper, I do two things. First, I present an alternative formalization of plg; this allows us to simplify Fine’s completeness proof for plg. Second, I formalize plmmg using an infinitary sequent calculus and prove that this formalization is sound and complete. (shrink)