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 delayedÂ 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 cleaning it up. But another imaging expert who had access to more of the data back in January 2007 said that they were "no better, no worse" than that used in previous studies. Perhaps the ongoing Congressional investigation will eventually provide clarity. So far, it's just been raising more questions.
Vytorin records created after the fact. Vytorin report
Insurers, PBMs mull Vytorin data. Vytorin report
Congress: M/S-P sat on bad news. Report from Congress
Companies saw Vytorin threat in 2005. Vytorin report
Congress: Were Enhance results secret? Enhance report
Congress promises Vytorin hearings. Vytorin report
Merck, Schering's Vytorin fails trial. Vytorin report