Failing the public health--rofecoxib, Merck, and the FDA.

By Eric J. Topol. New England Journal of Medicine, 2004

622 citations recorded by the source corpus.

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Short-term risk of death after treatment with nesiritide for decompensated heart failure: a pooled analysis of randomized controlled trials. (2005, methodology): “The sequence of events leading to the withdrawal of rofecoxib from the market underscores the importance of rigorous evaluation of safety from all data sources.(32,33) We analyzed data from the only 3 studies with at least 30-day follow-up that evaluated the effects of an infusion of nesiritide comp”
Why Most Published Research Findings Are False (2005, neutral): “there may be confl icts of interest that tend to “bury” signifi cant fi ndings [13].”
Guidelines for the clinical management of familial adenomatous polyposis (FAP) (2008, background): “9% of the patients assigned to placebo, necessitating premature cessation of the trial.(71) 72 A recently published meta-analysis of different NSAIDs confirmed the increased risk of cardiovascular diseases with rofecoxib.”
Validating matrix metalloproteinases as drug targets and anti-targets for cancer therapy (2006, background): “Even if they occur only rarely, the effects that follow the blockade of anti-targets will eventually manifest when large populations are expose”