Did Vytorin data really need cleanup?
What would bring one Vytorin-study consultant to say, “I’m an honest guy, and my first obligation is to tell the truth. Even if it means I’ll probably never get to do a scientific investigation with Schering-Plough again.” Those are the words of James Stein, a University of Wisconsin researcher who finds himself in the middle of a Congressional probe of the much-ballyhooed Enhance study. He’s the one who took issue with the “minutes” of a panel meeting in November, where experts discussed changing the Enhance endpoint. An imaging expert, he was shown some of the Enhance images, and pointed out potential problems with them–but when he saw the final study results, he concluded that those potential problems didn’t materialize. He said so, contradicting Merck and Schering-Plough’s contention that the study results were delayed because the data needed extensive cleanup. Schering’s Enrico Veltri told Forbes that the reason the data looks good now is that the company spent so much effort cle
