Prescription for Change

December 29, 2005

Expression of Concern: Bombardier et al., “Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis,” N Engl J Med 2000;343:1520-8.

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D.

We have recently obtained information regarding inaccuracies in data in the report of the VIGOR (Vioxx Gastrointestinal Outcomes Research) study by Bombardier et al.1 that raise concern about certain conclusions in the article.

The VIGOR study was designed primarily to compare gastrointestinal events in patients with rheumatoid arthritis randomly assigned to treatment with rofecoxib (Vioxx) or naproxen (Naprosyn), but data on cardiovascular events were also monitored. Three myocardial infarctions, all in the rofecoxib group, were not included in the data submitted to the Journal. The editors first became aware of the additional myocardial infarctions in 2001 when updated data were made
public by the Food and Drug Administration.

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