Opening statements are expected Thursday in Angleton, Texas, in the first trial of a wrongful death case brought by the family of a Vioxx user. Plaintiffs allege that Merck knew Vioxx presented serious risks to heart patients long before the company withdrew the drug last fall.
Merck & Co. Inc Statement to NPR, Friday, July 8, 2005
WHITEHOUSE STATION, N.J., July 8, 2005 -- Merck & Co. Inc., correctly and appropriately communicated about the benefits and possible risks of VIOXX. In addition, Merck promptly and extensively disclosed the VIGOR data to the scientific and medical communities, and in the press. Any suggestion otherwise is absolutely incorrect.
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 thrombotic events like heart attacks and strokes between VIOXX and placebo or VIOXX and the comparator NSAIDs like ibuprofen.
The VIGOR publication fairly and accurately described the results of the study of the pre-specified cutoff for analysis. The final data did not materially changed any of the conclusions in the article. Further, these events were all disclosed to the FDA and publicly at the FDA's Advisory Committee.
The CV discussion in the article focused on MI because the difference in the aggregate endpoint of confirmed thrombotic event was almost completely accounted for by MI; there were similar rates of strokes in the two groups.