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 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.

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)

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)

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)

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)

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)

© 2003 by The Johns Hopkins University Press.