An FDA advisory committee strongly agreed that self-evaluation and self-management of long-term statin drug use would not be in the best interests of the American people.

More Pharmacy Guidance?

Lovastatin is both safe and effective in lowering cholesterol, members of the Nonprescription Drugs and Endocrinologic & Metabolic Drugs Advisory Committees agreed. But the current drug-dispensing system in the U.S. simply is not set up properly to allow patient self-management of long-term use of a preventive medication, some committee members argued.

By a 19-5 vote, the advisory committee agreed that a study conducted by Johnson & Johnson/Merck -- which was presented in support of the OTC request -- did not demonstrate that patients could use Mevacor Daily 20 mg. safely and effectively on their own.

Along with other concerns, the panel noted that some people might not take the drug in the correct dose. There was also discussion of the possibility that pregnant women might take it. Although rare, lovastatin does have negative side effects, such as muscle damage.

Some committee members expressed interest in a system that would provide more behind-the-counter guidance from pharmacists, similar to the UK's approach.

Patients Uncertain

Lovastatin was not indicated for about two-thirds of the patients in the study, dubbed "Custom," and many of the participants sought their doctor's advice -- rather than self-selecting -- to decide whether to start taking it, the committee noted.

The study results did not persuade members to favor switching lovastatin to OTC status. However, they offered Merck some encouragement, suggesting the door would be open for reconsideration of the question in the future.