Medical ghostwriting is the practice in which pharmaceutical companies engage an outside writer to draft a manuscript submitted for publication in the names of “honorary authors,” typically academic key opinion leaders. Using newly-posted documents from paroxetine litigation, we show how the use of ghostwriters and key opinion leaders contributed to the publication of a medical journal article containing manipulated outcome data to favor the proprietary medication. The article was ghostwritten and managed by SmithKline Beecham, now GlaxoSmithKline (GSK) and Scientific Therapeutics (...) Information, Inc. without acknowledging their contribution in the published article. The named authors with financial ties to GSK, had little or no direct involvement in the paroxetine 352 bipolar trial results and most had not reviewed any of the manuscript drafts. The manuscript was originally rejected by peer review; however, its ultimate acceptance to the American Journal of Psychiatry was facilitated by the journal editor who also had financial ties to GSK. Thus, GSK was able to take an under-powered and non-informative trial with negative results and present it as a positive marketing vehicle for off-label promotion of paroxetine for bipolar depression. In addition to the commercial spin of paroxetine efficacy, important protocol-designated safety data were unreported that may have shown paroxetine to produce potentially harmful adverse events. (shrink)
In this essay, I argue that A. N. Whitehead's novel concept of prehension only makes sense as a form of panpsychistic idealism. After making the case for this view, I critical evaluate Lewis Ford's interpretation of prehension from his compositional analysis of Whitehead's metaphysical works.
This case study reports an instance of SmithKline Beecham's behind-the-scenes ghostwriting a letter to the editor in a medical journal article in the name of an academic physician. In order to respond to criticism that paroxetine caused severe withdrawal effects, SmithKline Beecham's marketing department hired a PR firm to ghostwrite three separate letters to spin a favorable impression of paroxetine vs fluoxetine and published one in the Journal of Clinical Psychiatry.
In this essay I examine the concept of an event within the context of P. F. Strawson's distinction between descriptive and revisionary metaphysics. As opposed to the linguistic treatment of events in the descriptive approach of Strawson and Donald Davidson, I make a case for the revisionary approach of A. N. Whitehead and W. V. Quine, according to which events are basic rather than dependent on substances.
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)
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.
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.
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)
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.
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.
In this essay, I provide an exposition of F. H. Bradley's arguments against relations and then critically evaluate his view using arguments advanced by William James and A. N. Whitehead. Against Bradley, I argue for the reality of relations as concrete aspects of the temporal process.
The first thing to note about the present work is that it is divided into twenty short chapters, all of which contain numbered sections averaging two to three pages in length. This organization adds to the concision and clarity of the book and works well with Heil’s attempt to present ideas in an unpretentious manner. The dust jacket tells us that the book is written in an accessible, nontechnical style that is intended for nonspecialists as well as seasoned metaphysicians. But (...) despite the organization and flow of bite-sized nuggets, I doubt anyone with less than graduate training in analytical philosophy will understand the problems and issues. A brief survey of the contemporary philosophers who get the most discussion should confirm the point. This includes: C. B. Martin, D. M. Armstrong, Frank Jackson, David Chalmers, Sidney Shoemaker, E. J. Lowe, Donald Davidson, Saul Kripke, and Hilary Putnam. (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.
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.
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.
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)
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.
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)
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.
This essay examines A. N. Whitehead’s philosophy of organism as a basis for an ecological ethics. His views are compared with those of deep ecologists and several problems with his panpsychism are considered in connection with the notion of intrinsic value in nature. In spite of problems raised by critics, this essay concludes that Whitehead’s philosophy provides a world view that offers a corrective to the disastrous course set by views that regard nature as an inert mechanism.
F. H. Bradley's metaphysical monism stands on the basis of his arguments against individuality and relations. In this essay, I argue that Bradley's arguments are flawed and make a case for the reality of asymmetrical, temporal relations via the process metaphysics of A. N. Whitehead.
There is perhaps no other branch of philosophy that has suffered as much scorn and ridicule as metaphysics. With bruised ego and much the worse for wear, it always re-emerges as methodologies become fatigued and the discussion of the central questions within exhausts itself. Even Bradley, the doyen of what was believed to be a metaphysics finished once and for all, can regain his place in the pantheon along side the likes of Plato, Descartes and Spinoza.
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.”.
Nihilism, as most commonly understood, is the existential thesis that life is without objective meaning, purpose, or intrinsic value. Medical nihilism is the radical skepticism, indeed cynicism, about the objectivity, purpose or value of medical interventions. According to Stegenga, it is the view that we should have little confidence in the effectiveness of medical treatments. Stegenga provides a rigorous epistemological investigation into the evidence for medical interventions, one that is informed by the methods of analytical philosophy and a Bayesian formalism.
While Whitehead and Russell’s collaboration on the foundations of mathematics ended with the publication of Principia Mathematica, both philosophers separately developed a philosophy of physics in the 1920s that was based on the revolutionary advances in modern physics. This essay explores the affinities and contrasts in Whitehead and Russell’s event ontology as a metaphysical foundation of physics and demonstrates the influence of Whitehead’s method of extensive abstraction on Russell’s metaphysics and epistemology.
In this Festschrift honoring the work of Timothy L. S. Sprigge, Sprigge summarizes his philosophy (a synthesis of absolute idealism, panpsychism, and utilitarianism), defends his position against criticism raised by philosophers in the preceding chapters of this volume, and offers in an addendum a proof for the existence of the Absolute, namely, a final and all-embracing Consciousness akin in many ways to Spinoza’s God. This defense of his philosophy consists mainly of responses to various points of criticism raised about his (...) view of time, the relation between his metaphysics and ethics, panpsychism, the Absolute, and animal rights. (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)
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.
In this volume of the Dictionary of Literary Biography, notable philosophers of the Anglo-American tradition, analytical philosophy, are represented as well as other philosophers who made significant contributions to American philosophy in the latter half of the twentieth century.
In this volume of the Dictionary of Literary Biography, notable British philosophers from the nineteenth and twentieth centuries are represented, including thinkers from the traditions of empiricism, idealism, logical positivism, and analytical philosophy.
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.
In this case study from litigation, I examine the origin of Monsanto-sponsored articles published in toxicology journals and the lay media that were designed to create doubt in critical evaluations of the herbicide, glyphosate. The role of ghostwriting and the use of third-party academics in the corporate defense of glyhphosate reveal that this practice extends beyond the corruption of medical journals and persists in spite of efforts to enforce transparency in industry manipulation of the scientific literature.
This article makes a distinction between pure and naturalized metaphysics and characterized F. H. Bradley's metaphysics as the former, according to which pure reason alone independent of the natural sciences discovers the true nature of reality. Bradley's view is critically evaluated via the the naturalized views of A. N. Whitehead and W. V. Quine.