Vytorin trial receives House scrutiny
Executive Summary
The delay in releasing results from a clinical trial completed in April 2006 is raising concerns about "apparent manipulation of trial data" at the House Energy and Commerce Committee. An explanation for the delay and a change in primary endpoint is requested from Merck and Schering-Plough CEOs Dec. 11, the same day the companies unveil their intention to stick with the original endpoint for the ENHANCE trial, comparing the effects of Vytorin (ezetimibe/simvastatin) to simvastatin alone in repressing artherosclerosis in patients with familial hypercholesterolemia. A posting on Schering-Plough's Web site stresses that "as of Dec. 11, neither the companies nor the investigators know the results of the trial. The trial remains blinded." Timing of the posting and letter is an "ironic coincidence," the company told "The Pink Sheet." Panel members continue to "look into scientific misconduct," a committee aide says (1"The Pink Sheet" Sept. 24, 3007, p. 3)...
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