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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.'
According to Merck & Co., the manufacturer of Vioxx, the VIGOR article fairly and accurately represents the results of the study. (Tesoriero HW, Tomsho R, Winslow R. Vioxx plaintiffs seek mistrial after allegation on Merck study. The Wall Street Journal. Dec. 10-11, 2005 A1, A9.) Merck contends that the three heart attacks at issue were appropriately excluded from the data presented in the article because the heart attacks occurred after the pre-specified data cutoff point for counting adverse events in the study. As cutoff dates are used in every clinical trial to define the period during which benefits and risks of a treatment are measured, Merck was simply abiding by the pre-specified study protocol. Furthermore, by February 2001, within 3 months after the publication of the article, Merck had provided to the FDA all of the data from the VIGOR study, including the three additional heart attacks.
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