The Paroxetine 352 Bipolar Study Revisited: Deconstruction of Corporate and Academic Misconduct

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

Experience and relations in the metaphysics of A.N. Whitehead and F.H. Bradley

The central purpose of this thesis is to examine the affinities and contrasts in the metaphysical systems of A. N. Whitehead and F. H. Bradley. Not only does this thesis aim to explore thoroughly and show exactly where these two philosophers agree, it also attempts to provide an analysis and evaluation of the arguments where conflict does arise.After a brief introduction which sets out Whitehead's and Bradley's respective positions on philosophic method and approach to metaphysics, Chapter II "Immediate Experience and Feeling ", shows where Whitehead and Bradley unite in their reaction against the ontology of scientific materialism of the 17th century cosmology. At this point various affinities are shown concerning the central role of the doctrine of feeling. But in Chapter III "The Analysis of Experience ", Whitehead's interpretation of feeling in terms of a distinctive pluralistic ontology is seen to conflict with Bradley's doctrine, and thus the stage is set for the central Chapter IV "Relations: Internal and External ". In this chapter Whitehead is confronted with Bradley's very rigorous and exhaustive analysis of the relational form. Despite Bradley's arguments it is here concluded that Whitehead's scheme can be shown to be consistent, given various modifications of the pluralist ontology in terms of the temporal asymmetry of one -way dependence. In Chapter V "Extension and Whole -Part Relations ", an attempt is made to defend the new doctrine of event -pluralism against a recent version of the ontology of material substance; and it is shown how such an ontology of events can account for the physical bodies which make up the system of nature. In the remainder of this chapter and the following Chapter VI "Time ", special problems of space and time are raised in connection with Whitehead's and Bradley's very different conceptions of the extended universe; and various attempts are made to defend Whitehead's view of process against an eternalistic view of the universe largely consistent with the Bradleian Absolute. However in the course of evaluating the arguments, it is discovered that Whitehead's ultimate metaphysical position must make certain concessions to the theory of eternalism; and this gives rise to the final Chapter VII "God and the Absolute ", where it is concluded that Whitehead's God must be seen as an 'Absolute open at one end'. Here Whitehead and Bradley merge on the notion of universal absorption of all finite actualities into one eternal actual entity; though Whitehead's conception, in the end, differs in the sense that God is not the only real entity, but one divine actuality which is in unison of becoming with the whole of creation

Challenging Medical Ghostwriting in US Courts

Xavier Bosch and colleagues expand upon a recent analysis by Simon Stern and Trudo Lemmens in PLoS Medicine and outline areas in which authors participating in medical ghostwriting could be held legally liable

A New Task for Philosophy of Science

We philosophers of science have before us an important new task that we need urgently to take up. It is to convince the scientific community to adopt and implement a new philosophy of science that does better justice to the deeply problematic basic intellectual aims of science than that which we have at present. Problematic aims evolve with evolving knowledge, that part of philosophy of science concerned with aims and methods thus becoming an integral part of science itself. The outcome of putting this new philosophy into scientific practice would be a new kind of science, both more intellectually rigorous, and one that does better justice to the best interests of humanity

Of Sophists and Spin-Doctors: Industry-Sponsored Ghostwriting and the Crisis of Academic Medicine

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

Biomedical Research and Corporate Interests: A Question of Academic Freedom

The current situation in medicine has been described as a crisis of credibility, as the profit motive of industry has taken control of clinical trials and the dissemination of data. Pharmaceutical companies maintain a stranglehold over the content of medical journals in three ways: (1) by ghostwriting articles that bias the results of clinical trials, (2) by the sheer economic power they exert on journals due to the purchase of drug advertisements and journal reprints, and (3) by the threat of legal action against those researchers who seek to correct the misrepresentation of study results. This paper argues that Karl Popper's critical rationalism provides a corrective to the failure of academic freedom in biomedical research