Public Not Ready for Over-the-Counter Statins

Dec. 11, 2007— -- 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.

"[The] dangers are that it may prevent people from seeing a cardiologist and not getting a proper evaluation for their heart disease," Zipes said.

"First of all, there are no symptoms of high cholesterol," Nissen agreed. "The only way you know is via a lipid profile, and interpretation of these is not simple.

"Doctors must judge risk, patients cannot."

Messmer added that this potential problem is particularly relevant in the case of statins -- which, unlike some other types of medicine, do not provide patients with noticeable proof of their effect.

"When a nonmedical person has heartburn, they either are getting relief or not," Messmer said. "The same applies to pain meds, cough and cold meds, and other OTC meds.

"It is so clearly the contrary with statins, I find it absolutely amazing the FDA would even waste the time to consider it ... I find it unbelievably ill-conceived that they would put the treatment of a component of one of our largest killers -- atherosclerosis -- into untrained hands."

Cutting doctors out of the picture could also lead to sporadic use, physicians noted.

"In most cases, statins are usually taken for life," said Dr. Jeffrey Brinker, professor of cardiology at Johns Hopkins University School of Medicine in Baltimore. "If one takes OTC medication, there is less psychological motivation to take it consistently."

Doctors Question Drugmaker's Motivation

Amid the concern over patient safety, consumer advocacy groups and physicians alike have lambasted Merck for the move, which they said arises from economic concerns.

Dr. Sidney Wolfe, director of the Health Research Group of the Washington, D.C.-based consumer advocacy group Public Citizen, testified in 2005 against a previous effort to grant Mevacor OTC status. He plans to testify again Thursday.

"For the switch of any statin, in this case lovastatin, none of the conditions are met and it is virtually certain that more harm than benefit would accrue to such an ill-advised regulatory decision," Wolfe said in his 2005 testimony. "Despite Merck and its highly paid academic partners' efforts to paint this switch as something positive, the analysis by FDA, with which I concur, seriously undermines any such conclusion."

The Consumers Union has also taken a stand against prescription-free Mevacor. While Mevacor achieved blockbuster status in its earlier days, sales have dropped since 2001 when its patent expired and generic versions entered the market. Last year, worldwide sales for Mevacor topped out at about $20 million.

Some doctors reacted with outrage at what they feel are money-driven motivations behind the move.

"How craven can the drug companies become?" asked Dr. Michael Good, a family practitioner with ProHealth Physicians in Middletown, Conn. "They should put their efforts to actually inventing something new instead of trying to milk old horses for more money at the public expense."

Associated Press reports contributed to this story.