Statin quo? The pros and cons of direct-to-consumer use

Manufacturers are trying to persuade the FDA to make the popular drugs available without a prescription.

By Susan J. Landers, AMNews staff. June 7, 2004.

Millions of people worldwide use statins, and the medication's safety record is admirable, so why not allow sales of these lifesavers without a prescription?

Physicians have varying answers.

Statins should be considered vitamins for the heart, say some, while others remain apprehensive at the prospect of these powerful drugs' over-the-counter sale.

"My gut feeling is that they should not be available over the counter," said Philippe O. Szapary, MD, an internist at the University of Pennsylvania School of Medicine's lipid clinic. "It's not like you just take a pill and you're done. Evaluations are necessary until a patient achieves target cholesterol levels."

But there is also the other side.

"I'm all for it," countered William Clifford Roberts, MD, director of the Baylor Heart and Vascular Institute in Dallas. "I think any method of trying to get more people on statin drugs is useful."

The debate about allowing consumers this direct access is serious. It touches on an important role physicians play in helping patients prevent heart disease by steering them to the correct medications, by determining an effective dose, counseling them on important lifestyle changes and monitoring them for adverse effects. A concern many have about the status change for statins is that much of this function could be lost if patients are able to pluck these medications from store shelves.

The FDA rejected pharmaceutical company requests for OTC availability for low-dose statins in the past, questioning whether the drugs could be safely and effectively used without physician guidance. But firms are gearing up for another try that could occur within the year.