【drug-news】Vytorin门事件焦点人物之一 James Stein
April 15, 2008, 10:56 am
Vytoringate: James Stein, ‘Man in the Middle’
Posted by Scott Hensley
As Congress investigates the delay in the release of data from Merck and Schering-Plough’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 Stein’s objections to a change in the standard for success in the trial. “We never made a recommendation to change any endpoints. We simply gave our opinion,” Stein (pictured) told Forbes. (See his refutation in the image from the report. For the full set of documents, see this post.)
“I’m an honest guy, and my first obligation is to tell the truth,” Stein told Forbes. “Even if it means I’ll probably never get to do a scientific investigation with Schering-Plough again.” Forbes called Stein, “Vytorin’s Man in the Middle.”
As the magazine’s Matt Herper noted, critics of the companies argue that technical problems with the Enhance study became an excuse to avoid facing a result that would hurt their $5 billion-a-year cholesterol drug franchise. The last patient finished the Enhance trial in 2006, and the data weren’t made public until January of this year. The companies defend their actions and say the documents released are consistent with their previous accounts of the study.
Stein told Forbes that the final data presented last month at the American College of Cardiology looked “quite good.” Forbes writes, “That contradicts the idea that the data needed so many months of cleanup.”
“I’m not concerned with what Merck or Schering think of me,” Stein told the magazine, “so long as they don’t call me dishonest.” [标签:content1][标签:content2]
作者:admin@医学,生命科学 2011-01-28 17:14