Public Not Ready for Over-the-Counter Statins

Many cardiologists and other physicians agree that offering a cholesterol-lowering statin drug to consumers without a prescription would be a terrible idea.

But just such a proposal is now being weighed by the U.S. Food and Drug Administration. Thursday FDA advisory committees will evaluate data submitted by drug giant Merck & Co., which supports over-the-counter use of its cholesterol drug Mevacor.

"I think this is a very clear call," said Dr. Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic Foundation and immediate past-president of the American College of Cardiology. "I do not think it is a good idea."

"OTC [over-the-counter] statins would be a very bad idea," agreed Dr. John Messmer, associate professor of medicine at the Penn State College of Medicine in Palmyra.

"While it is true that statins are indeed quite safe despite rumors to the contrary ... when a drug is available OTC the user should be able to judge whether it has had the desired effect. The nonmedical person is not in the position to decide if his or her cholesterol is low enough."

Dr. Douglas Zipes, distinguished professor of cardiology at the Indiana University School of Medicine in Indianapolis, agreed that the possible side effects of the drug lend weight to the argument that it should not be available without a prescription.

"I considered these issues when I was president of the American College of Cardiology, and we didn't support the over-the-counter use," Zipes said.

Still, Merck says that offering a low-dose version of the pill on store shelves may help millions without prescriptions ward off a first heart attack. Mevacor was the first cholesterol-lowering statin drug when it was introduced back in the 1980s. Since then, other drugs like Lipitor and Zocor have become available to the estimated 11 million Americans taking such drugs.

It's not yet clear whether Mevacor sold over the counter would cost much less than it does under prescription.

And some doctors cite these potential benefits -- though they also note that the move does not come without its fair share of considerations.

"The benefits are likely to be significant since a much larger base of patients would receive statin therapy than is currently the case," said Dr. Domenic Sica, professor of medicine and pharmacology at Virginia Commonwealth University Health System in Richmond.

Sica said that though such drugs carry "very minimal risk," he added, "the agency is concerned about two issues; the possibility of there being liver damage, and the use of these drugs in females of childbearing age."

This isn't the first time such a proposal has passed before the eyes of FDA advisers. Twice before, the idea has been rejected.

And history could repeat itself this time around. Though FDA reviewers said in a preliminary review released Tuesday that the drug could be a "reasonably safe and effective" option if used as directed, tests conducted by Merck showed that most consumers are ill-equipped to judge for themselves when the drug is needed.

The preliminary review subsequently concluded that consumer comprehension falls short of what would be needed to ensure safe and effective use of the drug in this way.

Cutting Doctors Out of the Loop?

Beyond the side effects of the drug, some worry that having the medicine available without a prescription could dissuade many from the crucial step of seeing a doctor about their condition.

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