Sunday, December 11, 2005
The New England Journal of Medicine this week released an editorial early by publishing on its web page a piece that will appear in print in the Dec. 29 issue: "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," by Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. The crux of the editorial is this:
We have recently obtained information regarding inaccuracies in data in the report of the VIGOR (Vioxx Gastrointestinal Outcomes Research) study by Bombardier et al. 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.
Until the end of November 2005, we believed that these were late events that were not known to the authors in time to be included in the article published in the Journal on November 23, 2000. It now appears, however, from a memorandum dated July 5, 2000, that was obtained by subpoena in the Vioxx litigation and made available to the Journal, that at least two of the authors knew about the three additional myocardial infarctions at least two weeks before the authors submitted the first of two revisions and 41∕2 months before publication of the article. Given this memorandum, it appears that there was ample time to include the data on these three additional infarctions in the article.
Conventional wisdom (as reported by the AP on Sunday): This can't help Merck in its defense of Vioxx suits pending around the country. [tm]