HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Friday, January 14, 2005

FDA rejcts over-the-counter Mevacor

Today the FDA recommended against over-the-counter sales of Merck's cholesterol drug, Mevacor, stating that patients need medical guidance for treatment of a chronic condition that has no symptoms and could require drugs for life.  Even though the safety of Mevacor is well-established, advisers worried that the wrong people might take it if sat on open drugstore shelves, particularly after a probable aggressive advertising campaign to sell it.  The vote on the advisory committee was 20-3.

The advisers expressed concerns due to studies that simulated over-the-counter sales, which indicated that 90 percent of people who took Mevacor did not satisfy  the requirements of the label. Some people were too young or not sick enough to need it. In other cases, the risk of heart disease was so high that the patients should have seen a doctor and received a stronger drug.

Once again, Kevin Drum of the Washington Monthly finds a quote that reflects quite accurately the FDA's concern,.  He quotes Michelle Cottle from the New Republic:

As a nation, Americans are apparently too stupid (or stubborn) to recognize that Big Macs and Big Gulps aren't the foundation of a healthy diet, but thanks to several gazillion dollars in direct-to-consumer drug advertising, we all consider ourselves experts in pharmacology.

....No matter what kind of qualifiers, disclaimers, and helpful tips Merck scrawls across Mevacor's box (or, more likely, crams onto a package insert printed in type so tiny it will make your eyes bleed), a fair number of self-medicating geniuses will think that the best way to prevent heart disease is to take two Mevacor for every six pieces of fried chicken they plan to eat that night. Don't laugh. It will happen and happen frequently.


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it seems that one of the biggest obstacles for otc approval is that the condition that is treated by statins is not readily apparent to the consumer, in the way that a headache, cold or even acid-reflux presents.

statins are designed to lower cholesterol (recent studies suggest effects on c-reactive protein as well). how on earth can a patient monitor his or her cholesterol without seeing a doctor and having blood tests? yet another example of the greed of pharma.

Posted by: japhy | Jan 15, 2005 3:09:51 PM

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