FDA Considers Sales for Cholesterol Drug

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Federal drug advisers on Thursday weighed whether to put a drug aimed at treating high cholesterol on drug store shelves alongside medicines for headaches, allergies and athlete's foot.

Supporters say making a low-dose cholesterol medicine available for this chronic condition without a doctor's prescription would help get needed treatment to millions of Americans who are at risk of heart disease.

"There is an enormous and growing cardiovascular public health problem that has not been adequately addressed," Dr. Richard Pasternak, Vice President for Clinical Research for Merck Research Labs, told the Food and Drug Administration's panel of scientific advisers at a hearing here.

He said providing an over-the-counter version of Mevacor, a cholesterol drug long available by prescription, would mean more people would use the drug, more would lower their cholesterol and the number of heart attacks would drop.

But advisers to the FDA were considering whether consumers would be able to accurately determine whether they need the drug. It's easy to know that you have a cough and to figure out if its bad enough to use a cough syrup, the thinking went. But a test is needed to measure cholesterol, and continued testing is necessary to see whether the drug is working.

"This is indeed a new model for OTC (over-the-counter) drug, " said Dr. Charles Ganley, Director of the FDA's Division of Over-the-Counter Drug Products.

Opponents worry that selling the drug to patients directly would allow them to skip doctor visits, where they might be told to change their diet and exercise_ both crucial in the effort to lower cholesterol.

There is also concern that people who could have been harmed by the drug, such as pregnant women and people with liver disease, might wind up taking it despite warnings and caveats.

FDA officials noted Thursday that people do not always realize that they are pregnant or that they have liver disease.

The application was filed by Johnson & Johnson-Merck Consumer Pharmaceuticals Co., a joint venture set up to market over the counter versions of drugs whose patents were expiring.

The panel of advisers was expected to make a recommendation Friday. The FDA usually follows the advice of its scientific committee.

The FDA turned down a similar request in 2000. In the years since, the drug companies have tested the idea through consumer surveys, focus groups and mock pharmacies, hoping to prove that average patients can figure out for themselves whether they need the drug at all and, if so, if the nonprescription strength is right for them.

But in documents released ahead of the meeting, the FDA detailed numerous flaws with these studies. For instance, the agency said, a study of how well people could understand the label that would be on the drug found that just 1 percent of people who said they could start using Mevacor "right away" were appropriate candidates for the drug. The other 99 percent did not meet the criteria or had a medical condition that made the drug wrong for them.

The drug is only meant for a slice of the population: 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.

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. As a group, statins made some $14 billion in the United States alone last year.

Still, less than half the people who could benefit take them. Over-the-counter sales are targeted at those with moderate risk who might benefit from a low-dose version of the pill.

Last year, British health officials approved the world's first nonprescription cholesterol drug, Zocor. Consumers must ask a pharmacist for the drug and answer questions to determine if it is appropriate.

The company says it will encourage patients to get their cholesterol checked after they begin treatment, though critics say there's no guarantee patients will do it. The company does not want the FDA to require tests of liver function, despite concerns that the drug can cause inflammation of the liver.

Officials have said they would charge about $1 for each daily 20-milligram pill if the over-the-counter sales are approved. That's less than Merck charges for the prescription version, but consumers who have health insurance would have to pay the whole thing, rather than just a co-payment.

Another drug company, Bristol-Myers Squibb Co., said last month it plans to submit a similar application for over-the-counter sales of a statin called Pravachol, but it has not yet done so.