Mark Moran

Clarifying the Vytorin Situation: Three Key Questions

Merck and Schering Plough delayed issuing results of the Enhance study for nearly two years and tried to change the primary endpoint in the late stages. To the extent that coverage is at all unfair to them, they brought it on themselves. And as this article shows, the press has consistently noted that Vytorin lowers LDL, while also noting that lowering a marker but not necessarily treating disease may no longer be good enough. This has been since seen with diabetes drugs as well, and even for cancer drugs, the FDA is looking for survival benefit rather than another proxy for efficacy.

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