FDA Advisers Reject Over-the-Counter Statin

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Some experts agree with the idea of over-the-counter statins.

"There is a public health benefit in making statins available over the counter," said Dr. Antonio M. Gotto Jr., a dean and professor of medicine at Weill Cornell Medical College in New York City, a former president of the American Heart Association, and a consultant for Merck.

Statins are safe and effective, Gotto said. "In addition, the American population has reached the point where they are able to assume a greater degree of responsibility for their own health care," he said.

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However, a preliminary FDA report released Tuesday concluded that the Merck proposal should be rejected, in part over worries that consumers would not be able to safely judge whether they were good candidates for the drug.

According to that report, Mevacor could be "a reasonably safe and effective" option -- if consumers used it properly. But studies done by Merck failed to show that most people could judge if they needed the drug or not. In addition, some 30 percent of those who said they would buy the drug over the counter have heart disease or diabetes or had had a stroke -- conditions that need a doctor's care, the report said.

The studies "have not convinced this reviewer that there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product," the preliminary assessment concluded.

Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, told federal regulators Thursday: "Making the cholesterol medicine Mevacor available over the counter could lead to widespread, and possibly dangerous, inappropriate use of the drug, a fear backed up by the maker's own data."

Nissen is opposed to the over-the-counter sale of statins on several counts.

People with high cholesterol don't know they have it, because there are no symptoms, Nissen said. "The only way you know is if you are tested," he added.

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