As Congress investigates the delay in the release of data from Merck and Schering-Ploughâ??s now infamous Enhance trial of Vytorin, one of the key players is speaking up.
James Stein, a cardiologist at the University of Wisconsin, had reservations about the way the companies were characterizing a meeting of experts on the trial, which failed to show that Vytorin was better than a generic statin alone in slowing the progression of cardiovascular disease as measured by ultrasound.
Last week the release of documents by a congressional committee made public Steinâ??s objections to a change in the standard for success in the trial. â??We never made a recommendation to change any endpoints. We simply gave our opinion,â? Stein (pictured) told Forbes. (See his refutation in the image from the report. For the full set of documents, see this post.