Merck & Co., Inc. Response to an Editorial Posted on the New England Journal of Medicine Web Site
Wednesday, December 8th, 2004.
In response to an editorial that appeared today on the New England Journal of Medicine website, Merck & Co., Inc. believes that it is important to emphasize that the company promptly and appropriately disclosed the results of the VIGOR (VIOXX Gastrointestinal Outcomes Research) study. Merck correctly communicated about the benefits and possible risks of VIOXX and extensively disclosed the VIGOR data to the scientific and medical communities, and in the press.
The VIGOR publication, which was peer-reviewed, fairly and accurately described the results of the study as of the pre-specified cutoff for analysis. The additional events referred to in the editorial were events that were reported after the pre-specified cut-off date and therefore were not included in the primary analysis reported in the New England Journal article. Nevertheless, these additional events were disclosed to the FDA in 2000, presented publicly at the FDA’s Advisory Committee in February 2001, included in numerous press releases subsequently issued by Merck, disclosed to physicians given a copy of the article by Merck and detailed in the updated prescribing information for VIOXX. We also note that these additional events did not materially change any of the conclusions in the article.
Merck is confident in its research. In the research that served as the basis of FDA approval, Merck conducted studies with almost 10,000 patients. Those studies showed similar rates of thrombotic events like heart attacks and strokes between VIOXX and placebo or VIOXX and the comparator NSAIDs like ibuprofen.
Finally, Merck only recently learned of this editorial. We have not had an opportunity to formally respond in the New England Journal of Medicine given the timing of its publication. Therefore, Merck looks forward to providing a more complete response to the editorial in the New England Journal of Medicine.
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