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Increased Scrutiny of Pharmaceutical Company Clinical Trials: The Defense Perspective
In recent large-scale pharmaceutical litigation, plaintiffs' counsel have concentrated significant resources seeking the details of how individual patients in pre- and post-marketing company clinical trials were assessed, characterized, and reported to the Food and Drug Administration ('FDA'). The reason is clear: They are seeking to develop (in the author's opinion unfairly) a story that the pharmaceutical company hid risks and overstated benefits. The efficacy and safety data generated by industry-sponsored studies, and the manner in which the data are analyzed and reported, have therefore become the focus of large-scale pharmaceutical litigation.
Recent events in the Vioxx' litigation show that plaintiffs' counsel are now expanding this approach to industry-sponsored studies submitted to medical journals, with apparent success. The editors of the New England Journal of Medicine ('NEJM') claim that they recently obtained information revealing inaccuracies in the data reported in the VIGOR (Vioxx Gastrointestinal Outcomes Research) study that calls into question some of the study's conclusions. (Curfman GD, Drazen JM, Morissey S. Expression of concern: Bombardier et al., Comparison of upper gastrointestinal toxicity of rofexicib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000; 343: 1520-8. N Engl J Med 2005; 353: 2813-14.) Although the VIGOR study was designed to compare gastrointestinal events in patients with rheumatoid arthritis treated with either rofecoxib (Vioxx) or naproxen (Naprosyn'), data on cardiovascular events were also monitored. According to the editors, three myocardial infarctions (heart attacks) in Vioxx patients were incorrectly omitted from the data submitted to the NEJM. The editors concluded that the omission of the three additional heart attacks ' which raised the total number of heart attacks in Vioxx patients from 17 to 20, as opposed to 4 in Naprosyn patients ' rendered certain calculations and conclusions in the VIGOR article 'incorrect' and 'misleading.'
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