Merck recently submitted its third application to the Food andDrug Administration (FDA) to allow it to sell its cholesterol-loweringdrug lovastatin in 20-mg tablets over the counter.1,2 Targetedconsumers are men over the age of 45 years and women over theage of 55 years who have levels of low-density lipoprotein (LDL)cholesterol of 130 to 170 mg per deciliter and an intermediate10-year risk of a cardiovascular event (5 to 20%) but no previousevent.1 Merck's arguments for the switch from prescription-onlyto over-the-counter sales focused on the "treatment gap" —at-risk persons who are not receiving therapy . . . [Full Text of this Article]
Problems with Nonprescription Statins
Inability of Consumers to Self-Select Drugs
Concern about Monitoring
Advertising and Marketing
Need for Oversight
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From the Departments of Internal Medicine and Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT.
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