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Studies: Cholesterol Drug May Prove Too Popular

Posted on: Friday, 14 January 2005, 18:00 CST

BETHESDA, Md. 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 advisers were told Thursday.

The cholesterol drug Mevacor has long been available by prescription. Drug companies are 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.

The drug companies say selling Mevacor over the counter would help provide 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.

But opponents worry that patients will 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.

FDA officials analyzed this data and found that many people said they would take Mevacor or actually took it even though it wasn't right for them.

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.

Pregnant or breast-feeding women and people with liver disease should not take the drug.

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.

Update

Previously: Prescriptions have been required for drugs that reduce cholesterol because patients must have blood tests to see if the drugs are suitable.

What's new: Two companies want to sell a low-dose cholesterol medicine over the counter. Opponents say direct sales would let patients skip doctor visits, where they might be told to change their lifestyle.

What's next: A panel of Food and Drug Administration scientific advisers is considering the request this week.

Source: Columbian

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