Leemon B. McHenry

Industry-Sponsored Ghostwriting in Clinical Trial Reporting: A Case Study

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.

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.

Key Opinion Leaders and Paediatric Antidepressant Overprescribing

Perhaps the most influential efficacy study of antidepressants in children has been the TADS study [11–13] . The main methodological criticism of the TADS study is that it included an unblinded comparison between cognitive behavioural therapy (CBT) alone and fluoxetine plus CBT. This was carried out in parallel to a doubleblind comparison between fluoxetine and placebo. The lack of patient blinding for medication status and placebo control for one half of the study is likely to have exaggerated the benefit seen in the fluoxetine plus CBT group who knew that they were not receiving placebo. The decision not to include a placebo in the CBT group was based on the belief that it was ‘both too expensive and too artificial to have clinical relevance’ [14] . This, however, is not a plausible explanation for why the CBT-only group could not have been converted into a CBT plus placebo group. In any case, the lack of placebo control for half the patients means that comparing results between parts of the trial, with and without a placebo control, is not valid. Yet The lingering controversy about the usefulness and safety of antidepressants for children and adolescents is likely to leave clinicians in a state of confusion. Some papers report that there is little evidence for efficacy and raise concerns about harm [1–3] ; others state that antidepressants are not only safe and effective, but also prevent suicides [4–7] . This journal has previously noted the influence on decision-making of irrational habits and misplaced trust in data submitted by the pharmaceutical industry [8, 9] . 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.

Ethical issues in psychopharmacology

The marketing of selective serotonin reuptake inhibitors in the psychopharmacological industry presents a serious moral problem for the corporate model of medicine. In this paper I examine ethical issues relating to the efficacy and safety of these drugs. Pharmaceutical companies have a moral obligation to disclose all information in their possession bearing on the true risks and benefits of their drugs. Only then can patients make fully informed decisions about their treatment.

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.

Science and the Pursuit of Wisdom: Studies in the Philosophy of Nicholas Maxwell

Nicholas Maxwells provacative 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 amd make progress toward a more civilized world. This volume of essays from an international inter-disciplinary group of scolars engages Maxwell in critical evaluaton and celebrates his contribution to philosophy spanning forty years. Several of the contributors, like Maxwell, took their inspiration from Sir Karl Poppers 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 though and then defends his views against objections in a concluding essay.

Whitehead and Bradley: a comparative analysis

This book has been digitized and deposited in the repository with the full permission of the publisher.

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.

Sprigge's Ontology of Consciousness

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-a-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.

Industry-Corrupted Psychiatric Trials

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.