FDA advisers debate safety of allowing over-the-counter sales of cholesterol drug

Thursday, January 13th 2005, 11:59 am

By: News On 6

BETHESDA, Md. (AP) _ Many Americans would reduce their chances of heart disease if a cholesterol drug now available only by prescription were sold over the counter, federal health advisers were told.

But the drug also might wind up in the hands of patients who aren't supposed to take it, came the retort.

An advisory committee to the Food and Drug Administration began meeting Thursday to consider a request to sell a low-dose version of the cholesterol drug Mevacor directly to consumers for the first time. A recommendation was expected Friday.

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 existing symptoms. And while a cough or cold is apparent, the only way to know one's cholesterol level is to be tested.

Sponsors say over-the-counter Mevacor would help get needed 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.

Part of the problem is consumer attitudes, said Jerry Hansen, a vice president at Johnson & Johnson-Merck Consumer Pharmaceuticals Co., a joint venture set up to market over-the-counter versions of drugs whose patents were expiring.

He said many patients would benefit from Mevacor today but don't want to take a prescription drug because ``they generally feel that a prescription is for someone who is sick.'' By contrast, he said, over-the-counter drugs are for ``someone who is healthy, like themselves.''

But opponents worry that selling Mevacor directly could encourage patients to skip necessary doctor visits, where they might get important advice about changing diet and exercise.

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.

According to the label proposed by the drug companies, Mevacor is only meant 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, family history of heart disease or an HDL _ high-density lipoprotein, or ``good'' cholesterol _ count of less than 40.

The study of label comprehension found that only 1 percent of people who said they could start using Mevacor ``right away'' were appropriate candidates for the drug.

The mock pharmacy found that of all the people who actually took the drug, just 10 percent met the label's criteria _ though there is no evidence that anyone in the study was harmed by the drug.

The companies used a looser standard in counting who took the drug appropriately. For instance, in the mock pharmacy study, they counted people who said they had talked with their doctors before taking the drug even though they didn't meet the criteria on the label. Under this definition, Merck said, 55 percent of those who took the drug did so appropriately.

The panel also heard concerns that women who are pregnant might take the drug. At issue was whether the label advising against it was sufficient to prevent that, and how significant the risk of damage to the fetus really is.

Also of concern is that people with liver disease, some of whom don't know they are sick, could be hurt if they take the drug.

There are also financial implications to the decision, although the FDA is not allowed to consider them. If the drug is sold over the counter, health insurance will no longer pay for it, shifting the cost from insurance companies to patients.

Mevacor was the first of the statin drugs, which lower cholesterol by limiting the buildup of artery-clogging fat deposits, reducing the risk of heart attack by about a third. Some $14 billion in statins were sold in the United States last year.

The application was filed by Johnson-Merck whose officials have said they would charge about $1 for each daily 20-milligram pill if over-the-counter sales are approved.

The FDA turned down a similar application for over-the-counter Mevacor in 2000.