Behind the scenes at Enhance: Schering-Plough statisticians reviewed some data before the study was complete, according to New Jersey's Star-Ledger. Was this preliminary review enough to show that the trial--which pitted Vytorin (Zetia plus Zocor) against Zocor alone--would fail to anoint Vytorin as the victor?
That's just one question raised in the Star-Ledger article, which contends that the Enhance trial was poorly designed from the start--that it, in effect, set itself up to fail. The story draws a picture of two companies desperate for another big drug to turnabout their fortunes. One expert even said the companies designed the study as they did because they needed a "home run" to satisfy Wall Street's insatiable desire for blockbuster drugs.
Unfortunately, the home run wasn't to be. And the study delay has, of course, drawn fire from Congressional and state investigators. For a complete picture, we'll have to wait for full data from Merck and Schering-Plough--scheduled to come next month at the American College of Cardiology meeting--and for more info from investigators.
- read the Star-Ledger report [1]
Related Articles:
Depression added to Vytorin, Zetia labels. Report [2]
FDA to review Enhance study. Report [3]
Merck, Schering defend embattled Vytorin. Report [4]
Vytorin defenders funded by drugmakers. Report [5]
Vytorin, Zetia scrips plummet. Report [6]
Links:
[1] http://www.nj.com/business/index.ssf/2008/02/how_high_hopes_ultimately_hurt.html
[2] http://www.fiercepharma.com/story/depression-added-to-vytorin-zetia-labels/2008-02-15
[3] http://www.fiercepharma.com/story/fda-to-review-enhance-study/2008-01-28?utm_medium=nl&utm_source=link
[4] http://www.fiercepharma.com/story/merck-schering-defend-embattled-vytorin/2008-01-25?utm_medium=nl&utm_source=link
[5] http://www.fiercepharma.com/story/vytorin-defenders-funded-drugmakers/2008-01-24
[6] http://www.fiercepharma.com/story/vytorin-zetia-scrips-plummet/2008-01-23?utm_medium=nl&utm_source=link