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FDA Panel Considering Over-the-Counter Statin
Date:12/13/2007

ins.

Merck is hoping that some new study data will sway the committee this time.

Some experts do agree with the OTC idea.

"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 and former president of the American Heart Association.

Statins are safe and effective, said Gotto, who is also a consultant for Merck. "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.

However, a preliminary FDA report released Tuesday concluded that the proposal should be rejected.

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 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.

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

"I am very strongly opposed to statins over the counter for a lot of reasons," Nissen said. People with high cholesterol don't know they have it, because there are no symptoms, he said. "The only way you know is if you are tested."

In addition, test results have to be interpreted to determine risk factors and whether a statin is needed or not, Nissen said. "I don't see how individuals can do that for themselves," he added.

Nissen also noted that statins need to be taken regularly
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