CHOLESTEROL: FDA Panel Discourages Selling Drugs OTC

      An FDA advisory panel yesterday decided that the anticholesterol drug Mevacor should not be sold over-the-counter, the AP/Washington Post reports. Both Merck & Co., which produces Mevacor, and Bristol-Myers Squibb, which manufactures the cholesterol drug Pravachol, want to sell low doses of the drugs to individuals with moderately high cholesterol. Several physician groups had urged the panel to allow the drugs to be sold without a prescription, saying that too many Americans who have high cholesterol go untreated, despite the fact that cholesterol is the biggest risk factor in heart disease. The groups also pointed out that one-third of heart attacks occur in patients whose cholesterol is higher than normal, but is not high enough for a prescription (7/14). While the advisory committee agreed unanimously that low doses of Mevacor are safe enough to be sold over-the-counter, it questioned whether lowering cholesterol for individuals with normal levels would reduce heart attack risk, a claim touted by Merck. Further, the committee expressed concern about whether patients would accurately diagnose themselves as eligible for the drug. David Orloff, the lead FDA official for cholesterol medications, said that if Mevacor was marketed to Merck's target group, "you'll end up treating a lot of people who are not at risk and, therefore, do not stand to benefit" (Rubin, USA Today, 7/14). Panelists also indicated that they would like additional information on how consumers would use the drug in "a real-world setting," as Merck studies generally involved patients who regularly received cholesterol tests. The panel is expected to review Pravachol today (Lueck, Wall Street Journal, 7/14).