Federal health advisers recommended against over-the-counter sales of a cholesterol drug, saying that patients need medical guidance in treating a condition that has no symptoms and may require drugs for life to stay healthy.
The panel advising the Food and Drug Administration also voiced concern that women who are pregnant, and may not know it, will wind up taking Mevacor and possibly damage the developing fetus.
The vote was 20-3.
Advisers expressed concern that in studies simulating over-the-counter sales, most of the people who opted to take Mevacor didn't meet the requirements of the label. Some people were not at high enough risk of heart disease to need the drug — they were too young, for instance, or their cholesterol levels weren't high enough. In other cases, their risk of heart disease was so high that they should be seeing a doctor and possibly receiving a stronger drug.
"I think that it is the right thing to do but I don't think we're there yet," said Dr. Frank F. Davidoff, editor emeritus of Annals of Internal Medicine.
The FDA isn't bound by its advisers' recommendations but usually follows them. The agency has been under intense scrutiny lately by critics who question whether it is vigilant enough in policing the safety of drugs already on the market, and that criticism could weigh on the government as it makes a final decision.
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.
Several members of the panel said they would like to see an in-between option, where patients can buy the drug without a prescription but only after speaking with a pharmacist. This option is available in Britain, which last year began selling a similar drug, Zocor, under these rules. And U.S. states sometimes order the drugs only be sold be from "behind-the-counter."
FDA officials said they believe it would take a change in law to make that option available nationally under FDA rules, though they were consulting their attorneys to be certain.
In arguing for over-the-counter status, sponsors said 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. Many patients, they said, are more comfortable taking a drug over the counter than by prescription because they don't think of themselves as sick.
But the companies' own research found that only 10 percent of the people who opted to take the drug in a mock pharmacy study met the strict guidelines on the label.
Most members of the panel also expressed concern that patients will not receive the medical guidance needed to make good decisions about whether the drug is 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.
The FDA 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 also heard concerns that women who are pregnant might take the drug. Experts told the panel that animal studies have suggested a risk to the fetus, and seven deformed babies have been born to women using this drug. Additionally, the panel was told that an unknown number of pregnancies may have miscarried because the would-be mother was taking the drug.
For most people, the drug has a long history of being safe and effective, though it has never been distributed without a doctor's prescription.
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.
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.