Companies saw Vytorin threat in 2005

Merck and Schering-Plough officials overseeing the Enhance study saw a threat to Vytorin back in late 2005, the Wall Street Journal reports. Study participants were healthier than officials thought they would be--meaning that it could be harder for Vytorin to show its stuff. That's also when the companies spotted the "implausible" data previously cited as a reason for the long delay in making the study results public.

The WSJ turns up some other behind-the-scenes stuff in this preview to the study presentation at the American College of Cardiology meeting March 30. For instance, Merck and Schering-Plough brought in an outside research team to compete with the study's independent overseers on reading image data, then ended up taking the whole effort in-house. Dr. John Kastelein, the outside scientist who led the study, now says the data [1] would have been made public months earlier if he'd had control of it.

The big questions Enhance has raised--questions likely to get bandied about with increasing intensity after the presentation--are these, the WSJ notes: How much control should sponsors have over clinical trials that influence doctors and regulators? And just how valuable are cholesterol-lowering drugs? Expect lots of chatter as the week wears on.

- read the WSJ article [2]
- see the item [3] in the WSJ Health Blog
- check out a nice background piece [4] on Enhance and statin use in Forbes

Related Articles:
Congress: Were Enhance results secret?
FDA to review Enhance study [5]
Congress promises Vytorin hearings [6]
Merck, Schering defend embattled Vytorin [7]
Merck, Schering's Vytorin fails trial [1]