F.D.A. Panel Rejects Over-the-Counter Cholesterol Drug

Government advisers rejected on Thursday Merck’s bid for over-the-counter sales of Mevacor, the cholesterol-lowering drug. Too many people would mistakenly use the drug if it no longer required a prescription, advisers to the Food and Drug Administration concluded in a 10-to-2 vote against the nonprescription sales.

The advisers, however, were struck by how many people, in a study of almost 1,500 potential customers, wanted to buy the drug even though they were bad candidates. A quarter of people who wanted the pill did not have a high enough risk of heart disease to qualify, meaning they would face unnecessary side effects. Worse still, 30 percent of very high-risk people — those who have heart disease or diabetes or had survived a stroke — wanted Mevacor; these are people who should be under a doctor’s care. Merck said many of them were not seeing a doctor and that a little treatment was better than none. Yet more than 30 percent of patients already taking prescription cholesterol-lowering drugs said they wanted the over-the-counter version. Half said they would drop the more potent drug in favor of low-dose Mevacor.

Bonnie - all I can say is thank goodness the committee has a conscience. Now, let's wait and see what the FDA decides. history has shown they side with the advisers, but you never know when billions are at stake.