Thumbs Down on OTC Statin

The FDA recently turned down a request by Merck to allow its cholesterol-lowering statin drug Mevacor to be sold over the counter. The December HealthFacts supported non-prescription status—not because we see Mevacor as safe or particularly effective. Rather it was a position taken in favor of informed decision-making.

The statistics regarding who is taking statins in the U.S. show that doctors are not prescribing these drugs according to the best clinical trials. The overwhelming majority of people on statins do not have heart disease—i.e., they are the least likely to benefit. If people had access to clearly written explanations of the studies supporting their prescription drugs, perhaps their decisions would be more informed than those of their doctors.

With some exceptions, prescription drugs do not automatically come with FDA-approved printed information, though it comes with virtually all drugs sold over the counter. The quality of the written information the consumer receives is likely to be better once a drug can be purchased without a prescription because it is generated by drug makers with FDA oversight. When a prescription drug comes with written information, it is often pharmacy-generated material that is of uneven quality.

The recommendation to turn down Merck’s request was made at a joint meeting of the FDA’s Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committees. Arthur Levin, director of the Center for Medical Consumers, served as the consumer representative on these committees. He voted with the majority against OTC status for Mevacor because Merck’s own study showed that, despite intensive educational efforts, a substantial number of people did not understand who should take a statin and who should not.

Maryann Napoli, Center for Medical Consumers © March 2008