Merck, Schering backpedal on Vytorin

All right, already. Merck and Schering-Plough have responded to public outcry over their plans to re-jig a study of Vytorin, a joint product that combines Merck's Zocor and Schering-Plough's Zetia. The ENHANCE trial wrapped up last year, but results haven't been released. Here's the background: Funded by the two companies, ENHANCE compares Vytorin to Zocor alone. If Vytorin proves superior to the now-off-patent Zocor, doctors might prescribe the $3-per-day brand name drug instead of Zocor's generic competition.

Last month, Merck and Schering-Plough said they planned to change the study's primary endpoint. Previously, the trial was focusing on the drugs' ability to keep arteries clear in three different spots per patient; the companies wanted to change that to the carotid artery alone.

But last week, lawmakers demanded data from the companies about the clinical trial, saying they were concerned about the delay in results and about the "apparent manipulation of trial data." Now, the drug makers are back-pedaling; they'll stick to the original criteria.

- see the House Committee on Energy and Commerce letter [1]
- read the UPI report [2]
- check out the WSJ article [3] about the study's lead investigator
- here's more background [4] from the Star-Ledger

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