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.
Nicholas Maxwell's provocative and highly-original philosophy of science urges a revolution in academic inquiry affecting all branches of learning, so that the single-minded pursuit of knowledge is replaced with the aim of helping people realize what is of value in life and make progress toward a more civilized world. This volume of essays from an international, interdisciplinary group of scholars engages Maxwell in critical evaluation and celebrates his contribution to philosophy spanning forty years. Several of the contributors, like Maxwell, took (...) their inspiration from Sir Karl Popper’s philosophy of science and were connected to the department he created at the London School of Economics. In the introductory chapter, Maxwell provides an overview of his thought and then defends his views against objections in a concluding essay. -/- . (shrink)
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.
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.
Ghostwriting for medical journals has become a major, but largely invisible, factor contributing to the problem of credibility in academic medicine. In this paper I argue that the pharmaceutical marketing objectives and use of medical communication firms in the production of ghostwritten articles constitute a new form of sophistry. After identifying three distinct types of medical ghostwriting, I survey the known cases of ghostwriting in the literature and explain the harm done to academic medicine and to patients. Finally, I outline (...) steps to address the problem and restore the integrity of the medical literature. (shrink)
This essay compares the fundamental metaphysical principles, the Categoreal Scheme of A. N. Whitehead's Process and Reality with the axiomatic-deductive scheme of Whitehead and Russell's Principia Mathematica to reveal the influence of mathematical logic on Whitehead's metaphysics.
Ghost-Managed Medicine exposes the conspiracy to conceal all of the players in the marketing of drugs, including ghostwriters, key opinion leaders, patient advocacy organizations, contract research organizations, publication planners, and even medical journal editors and publishers. The credibility of the claims conveyed by the industry depends on the invisibility of these players.
In this essay I make a case for a number of common themes between A. N. Whitehead and W. V. Quine in their approach to ontology. Both philosophers espoused a view of metaphysics as continuous with natural science and stressed the importance of physics in the development of ontology. As a consequence of the revolutionary developments in modern physics, both Whitehead and Quine contend that events are ontologically basic, but differ on the status of properties in their respective systems.
The problem of ghostwriting in corporate-sponsored clinical trials is of concern to medicine, bioethics, and government agencies. We present a study of the ghostwritten archival report of an industry-sponsored trial comparing antidepressant treatments for bipolar depression: GlaxoSmithKline (GSK) paroxetine study 352.
Sergio Sismondo argues that pharmaceutical industry-sponsored research and ghostwriting produce genuine knowledge and science (albeit commercial science) not different from established medical science. In this essay I critically evaluate Sismondo' view and conclude that the commercial medical science that has created the ghostwriting industry is a corruption of science and not merely science done in a new corporate mode. Serious harm to patients has resulted from misrepresented commercial biomedical research.
Karl Popper's celebrated theory of falsification provides a rigorous view of science but it has been criticized as failing to explain how science makes progress. In this essay, I compare Popper's falsificationism with Nicholas Maxwell's aim-oriented empiricism and examine the role that metaphysics plays in explaining scientific progress.
Analytic philosophers have criticized A. N. Whitehead’s metaphysics for being obscure, yet several such philosophers have espoused positions in metaphysics and philosophy of mind that were advanced by Whitehead in the 1920s. In this paper, we evaluate the merits and demerits of these criticisms by Bertrand Russell, W. V. Quine, Karl Popper and others and then demonstrate the affinities and contrasts in the positions advanced by Galen Strawson, David Chalmers, Thomas Nagel and Whitehead regarding so-called “analytic panexperientialism.”.
Recent developments in cosmology and particle physics have led to speculation that our universe is merely one of a multitude of universes. While this notion, the multiverse hypothesis, is highly contested as legitimate science, it has nonetheless struck many physicists as a necessary consequence of the effort to construct a final, unified theory. In Process and Reality, his magnum opus, Alfred North Whitehead advanced a cosmology as part of his general metaphysics of process. Part of this project involved a theory (...) of cosmic epochs which bears a remarkable affinity to current cosmological speculation. This paper demonstrates how the basic framework of a multiverse theory is already present in Whitehead’s cosmology and defends the necessity of speculation in the quest for an explanatory description. (shrink)
Timothy Sprigge advanced an original synthesis of panpsychism and absolute idealism. He argued that consciousness is an irreducible, subjective reality that is only grasped by an introspective, phenomenological approach and constructed his ontology from what is revealed in the phenomenology. In defending the unique place of metaphysics in the pursuit of truth, he claimed that scientific investigation can never discover the essence of consciousness since it can only provide descriptions of structure and function in what we normally think of as (...) physical existence. In this paper I present a critical evaluation of Sprigge's view focusing in particular on his conception of the nature of scientific inquiry vis-à-vis the ambitious project of his metaphysics. I argue that a naturalistic metaphysics provides a more adequate approach to the relation between science and metaphysics. (shrink)
In his magnum opus, Process and Reality, Alfred North Whitehead claims a special affinity to Oxford philosopher Francis Herbert Bradley. McHenry clarifies exactly how much of Whitehead's metaphysics is influenced by and accords with the main principles of Bradley's "absolute idealism." He argues that many of Whitehead's doctrines cannot be understood without an adequate understanding of Bradley, in terms of both affinities and contrasts. He evaluates the arguments between them and explores several important connections with William James, Josiah Royce, George (...) Santayana, Bertrand Russell, and Charles Hartshorne. (shrink)
T. L. S. Sprigge produced an eclectic yet highly original system of metaphysics and ethics, a synthesis of panpsychism, absolute idealism, and utilitarianism, at a time in which orthodox analytical philosophy could only view this system as an anachronism of the nineteenth century. His critics claim that his philosophy has only historical interest to a small group of specialists in the relatively dormant tradition of British Idealism, that an attempt to defend his view of consciousness is a hopeless nonstarter, and (...) that his Spinozistic monism can have no relevance in our intellectual culture.1 Yet others have defended Sprigge as the "most independent of thinkers within the field of metaphysics" and salute him as "a .. (shrink)
W.V.O. Quine and A.N. Whitehead shared a dualistic ontology of concrete and abstract objects but differed sharply on the status of properties. In this essay, we explore Whitehead’s reasons for admitting properties into his ontology and Quine’s objections. In the course of examining Quine’s position we demonstrate some deficiencies in his position and conclude that in spite of his claims, neither space-time coordinate systems nor classes can do all the ontological work of properties.
The idea that prescribing physicians should be guided by the most reliable scientific evidence seems obvious, but the actual methodology of evidence-based medicine was only introduced in the early 1990s by an international group of clinicians and researchers led by Gordon Guyatt. Since then it has provided a new paradigm for the scientific foundation of medicine and has influenced other disciplines outside of medicine, for example, evidence-based psychotherapy, science and government. The novel concept of evidence-based medicine is based on hierarchies (...) of evidence from opinions of respected authorities, mechanistic reasoning, and reports of expert committees at the bottom to... (shrink)
This essay examines the question of the ontological basis for historical propositions and contrasts the positions of A. N. Whitehead and George Santayana, i.e., presentism vs. eternalism. I argue that Whitehead's presentism is a more satisfactory solution to how propositions refer to the past.