Krumholz, FDA speak on Vytorin

The debate over cholesterol meds this week has been something of a he said-he said-she said-he said-she said phenomenon. Everyone has an opinion.

Some people's opinions count for more than others, of course. Take Harlan Krumholz, the Yale doctor who was so vocal during the Vytorin panel at the American College of Cardiology last weekend. Schering-Plough subsequently accused Krumholz of bias, saying he dominated the panel rather than letting all the members speak equally. "We had a verdict delivered by one individual who dominated," a Schering official said.

Krumholz shot back yesterday, telling Pharmalot that he wasn't biased, simply in favor of sticking to drugs with proven benefits over those whose benefits are more uncertain. "We have little data about [Zetia, one of the two active ingredients in Vytorin]. And what we have from Enhance does not inspire confidence. It makes us think it is less likely that the drug will be ultimately shown to be beneficial."

But another voice that carries weight--Robert Temple, a senior FDA official--says it's premature to dismiss the Merck/Schering-Plough drug; it did, after all, cut bad cholesterol very well and it also lowered an inflammatory marker known as c-reactive protein. Temple rates arterial plaque--which Vytorin didn't affect much--as a less important surrogate marker than cholesterol.

But Temple also notes that there are still no outcomes data on Vytorin. And that data will be years to come--2012 now that the Improve-It trial has been expanded. So in the meantime, as the Wall Street Journal Health Blog says, expect the chatter to continue.

- read the Health Blog item
- see Krumholz's response at Pharmalot

ALSO: Schering-Plough backdated the starting point of the outcomes test for Vytorin. Criticized for dragging its feet on starting outcomes research on Zetia, approved back in 2003, the company changed the Improve-It trial launch date to October 2005 from February 2006 in a government database. A Merck/Schering-Plough spokesman said the later date reflected the trial's start outside the U.S., and the earlier marked the date of the first dosing in the U.S. Report

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