Merck is once again trying to sell its widely prescribed statin, Mevacor, over the counter, and an FDA advisory panel is listening to arguments today. (I wrote about Merck's second doomed attempt to do the same back in 2005 for my first Reason feature) As one cardiologist told me then, "We're talking about the thing that kills more people than any other disease in America…We're talking about millions of lives saved." Merck has sold a statin OTC in Britain for years now.
The FDA confirms that Mevacor is effective and extremely safe if used properly, but has long doubted the ability of consumers to read directions and follow them. ABC News finds a long list of selfless, kindly cardiologists with absolutely no interest in the status quo to argue that consumers can't possibly deal with their cholesterol problems without… the help of a cardiologist. Also, drug companies are profit-driven. Not like cardiologists.
"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.
"[The] dangers are that it may prevent people from seeing a cardiologist and not getting a proper evaluation for their heart disease," Zipes said.
And patients who lack health insurance and can't afford the doctors' visits or the price of a prescription drug? Oh well.