Bioethics Discussion Blog: FDA Panel Backs Rationale for Over-the-Counter Mevacor

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Friday, January 14, 2005

FDA Panel Backs Rationale for Over-the-Counter Mevacor

Today's FDA panel backed the rationale for OTC Mevacor. What the FDA will finally decide is yet to come.
From today'sBloomberg News Service: "In today's deliberations before deciding whether to recommend that the FDA approve the application, the committee voted 25 to 0 to tell the agency that Merck and marketing partner Johnson & Johnson showed enough reason for using a 20-milligram dose of Mevacor to help people reduce their LDL, or bad, cholesterol, to a recommended level of less than 130 milligrams a deciliter.

The panel also voted 25 to 0 against recommending that the FDA require liver tests and found that the risk of muscle damage from the medication is ``acceptable.'' Statins reduce the liver's production of cholesterol, and the medicines also can cause muscle and kidney damage"

My question would be: what are the pharmaceutical affiliations of the members of the FDA panel and are they looking at the decision from a purely scientific and medically oriented point of view or also considering the financial implications of the switch? If, the latter, then their conclusions may be suspect and unethical. ..Maurice.

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