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One OTC Statin Out, One More To Go

I was somewhat relieved to read an FDA advisory committee rejected Merck's request to grant over-the-counter (OTC) status to Mevachor late Friday afternoon. Folks, it didn't look good early on, as Mevachor sailed through early voting last Thursday by the FDA. What I suspect had much to do with the committee's final decision: A Merck's study, which simulated pharmacies selling Mevacor, failed to show consumers could properly decide on their own whether to take the statin. (Although the FDA must make a final decision on Mevachor by Feb. 24, the agency typically follows the recommendations of its advisory committee.)

The major concerns:

  • Almost 60 percent of patients who used OTC Mevachor still talked to a physician.
  • Virtually all (90 percent) of patients didn't meet at least ONE of Mevachor's criteria (used by women older than 55 or by people whose LDL cholesterol levels didn't match the stated range on the box).
  • The harmful use of Mevachor by future mothers early in their pregnancies.

FDA committee members wished Mevachor could be sold the way Zocor (another statin in the Merck family) is in Great Britain: Although patients can buy Zocor over the counter, it's stored behind the counter for several years making it necessary to ask for it.

Remember when it comes to Big Pharma and BILLIONS of dollars at stake, nothing is as simple or safe as it appears on the surface. Because Mevachor is "off patent," it now competes with lovastatin for the generic prescription market. However, when a drug converts to OTC, the manufacturer is given an exclusive three-year window in which to sell it. That probably has a great deal to do with Bristol Myers-Squibb seeking OTC status for Pravachol whose exclusive window ends in spring 2006.

Just another reminder greed is at the root of all this political jockeying, and concern for your health is way down on the totem pole. Virtually no one needs statin drugs, especially when an optimized diet based on your body's unique nutritional type will lower your cholesterol naturally.

I urge you to read more about the truth about statins on a special page I've posted that collects links to the more popular drugs and their horrible side effects.

USA Today January 17, 2005

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