ABSTRACT
The protocols for the two trials differed markedly from the published paper in design, outcomes, duration of follow-up and analysis, and the advantage of celecoxib disappeared when the protocol-specified analyses were performed by independent researchers. The Food and Drug Administration's (FDA) advisory committee concluded that, based on the full data, celecoxib exhibited no advantage in reducing ulcer complications over the two old, much cheaper drugs. Furthermore, in 2005, the US National Cancer Institute published a trial of celecoxib for prevention of colorectal adenoma in the New England Journal of Medicine, which was terminated prematurely for safety reasons, as celecoxib increased significantly cardiovascular events. The FDA’s statistical reviewer explained why the company’s arguments for the 6-month analysis were obviously invalid. A meta-analysis conducted by independent researchers using FDA data showed in 2006 that celecoxib doubles the number of heart attacks compared with placebo.
