A statin is any of a group of drugs that act to reduce levels of fats, including triglycerides and cholesterol, in the blood. For the past 7 years, Merck & Co. has been urging the U.S. Food and Drug Administration to approve an over-the-counter statin drug for use by the general public. The drug is named Mevacor^®. In December, an FDA panel voted “no” to Merck’s request, the third time they have done so during this 7 year period.

By a vote of 10 to 2, the FDA’s Nonprescription Drugs Advisory Committee said that it would be too difficult for consumers to decide on their own if they were a good candidate for the statin drug. Popular statins now available through a doctor’s prescription include Lipitor^®, Crestor^® and Zocor^®.

In 2000 and in 2005, the FDA rejected similar proposals from Merck because of concerns about how the drug would be used by consumers, its potential side effects and the need to monitor people taking statins. Groups such as the American Medical Association and Public Citizen had lined up against Merck’s latest request.

“The third time is not the charm,” Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, said before the vote. “It’s time to move on.”

Dr. Nissen stated concern for 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. “The only way you know is if you are tested.” Nissen also noted that statins need to be taken regularly to be effective, but data indicate that over-the-counter medications are not usually taken consistently.

Statins can have rare but serious side effects, such as liver abnormalities, and are not recommended for pregnant women. “This is not a disease that you can treat with a one-size fits all approach. That’s what’s being attempted here with a 20 milligram, low-dose statin,” Dr. Nissen said. “I see no public health advantage in doing this and I see lots of potential problems.”

A preliminary FDA report had 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 the report, Mevacor could be “a reasonably safe and effective” option if consumers used it properly. However, Merck’s studies failed to show that most people could judge if they needed the drug or not. In addition, some 30% of people who said they would buy the drug over the counter also have heart disease, diabetes or had suffered a stroke. These are all conditions that need a doctor’s care, according to the FDA report.

Mevacor was the first statin drug to receive FDA approval in February 1997 and also the first to have its patent expire in December 2001.

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