Easier Access Sought for Cholesterol Medication

Vast numbers of people would take a cholesterol drug if it were offered over the counter even though they don’t meet the medical criteria, federal health advisors were told Thursday.

The cholesterol drug Mevacor has long been available by prescription. Drug companies are now asking the Food and Drug Administration for permission to sell a low-dose version directly to consumers for the first time.

The advisory committee that is meeting through today will make a recommendation to the FDA, which usually follows its panels’ advice.

Allowing over-the-counter sales for Mevacor would put a new sort of medication on drugstore shelves. Unlike treatments for coughs, colds and allergies, Mevacor is meant to prevent future heart disease rather than treat symptoms.

The drug companies say selling Mevacor over the counter would help provide treatment to millions of Americans who are at moderate risk of heart disease or need to lower their cholesterol but are not taking helpful drugs.

“There is an enormous and growing cardiovascular public health problem that has not been adequately addressed,” said Dr. Richard Pasternak, vice president for clinical research for Merck Research Labs.

But opponents worry that patients will skip necessary doctor visits. And there are questions about whether consumers will accurately determine whether the drug is right for them.

To answer that, Merck and partner Johnson & Johnson conducted a pair of studies. One tested whether consumers would understand the label; the other simulated a real-world situation and recruited potential users into a mock pharmacy to see who would buy and use the drug.

FDA officials analyzed this data and found that many people said they would take Mevacor or actually took it even though they should not.

According to the label proposed by the drug companies, Mevacor is meant only for men 45 and over and women 55 and older whose LDL -- low-density lipoprotein, or “bad” cholesterol -- count is between 130 and 170. They should also have at least one risk factor for heart disease, such as smoking, high blood pressure or family history of heart disease.