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FDA Considers OTC Statin Status For Mevacor

A little more than a year ago, there was talk in the business press drugmakers Bristol Myers-Squibb and Merck would file separate requests with the FDA to sell their statin drugs, Pravachol and Mevacor respectively, over the counter. That intention has finally become a reality, with Merck's application being considered by an advisory committee Jan. 13-14 and Bristol Myers-Squibb announcing it will seek the same status for Pravachol.

Four years ago, Merck's request was denied because an FDA committee had serious questions consumers would use Mevacor correctly. However, Merck claims it has a study that shows consumers can handle those decisions. And British regulators recently approved another statin drug, Zocor for OTC status in August.

The major concern voiced in the piece: One expert who smartly pointed out such deregulation is a bad idea because OTC drugs are meant to treat short-term conditions, and high cholesterol "has none of those things." Amen to that, but the problem is much more complex than that.

Folks, the bottom line is that statin drugs are truly dangerous. In fact, there are only a very small handful of people who benefit from them, far less than one in 100. Almost anyone can normalize their cholesterol levels by eliminating grains and sugars, exercising and retooling your diet based on your body's unique nutritional type.

Andm besides there are only a handful of people with genetic issues who require statin drugs, and their cholesterol levels are typically 350 or higher.

USA Today December 28, 2004

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