Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data

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Abstract
During its brief availability on the worldwide market, rofecoxib, a selective cyclooxygenase 2–selective agent, was a striking commercial success, its sales reaching $2 billion annually soon after its introduction in May 1999. Merck & Co Inc, Whitehouse Station, New Jersey (hereinafter, “Company”), the maker of rofecoxib under the brand name Vioxx, promoted it as a safer alternative to traditional nonsteroidal anti-inflammatory drugs (NSAIDs), although there were concerns about its cardiovascular adverse effects early in its development, years before its launch.1,2 In September 2004, the manufacturer voluntarily withdrew rofecoxib from the market after an interim safety analysis indicated that the drug was associated with increased risk of cardiovascular events within the Adenomatous Polyp Prevention on Vioxx (APPROVe) trial.3 The APPROVe trial, which tested the hypothesis that rofecoxib reduced the risk of colon polyp recurrence (and thus colorectal cancer), was terminated early by its data safety and monitoring board (DSMB). In November 2004, the manufacturer's chief executive officer testified to the United States Senate Committee that “Until data from [APPROVe] . . . , the combined data from randomized controlled clinical trials showed no difference in confirmed cardiovascular event rates between Vioxx and placebo.”4