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Re: rafunrafun post# 66672

Monday, 12/14/2015 6:23:28 PM

Monday, December 14, 2015 6:23:28 PM

Post# of 425795
Could this be a new lawsuit by Merck, 1A right, truthful and non misleading since Improve-It results showed that a combination treatment known as Vytorin, comprising Zetia and an older cholesterol-lowering drug, simvastatin, reduced the rates of heart attack, stroke and death compared with simvastatin alone by 6.4% but the panelists voted 10-5 against allowing Merck to make the claim, saying they were not convinced the benefit was clinically meaningful, especially since some patient data was missing.

"The benefit here is small," said Dr. Milton Packer, distinguished scholar in cardiovascular science at Baylor University Medical Center. "It is not robust. You blink and you miss it, and you wonder if you care or don’t care."

The FDA is not obliged to follow the advice of its advisory panels but typically does so.

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