- The Washington Times - Thursday, January 13, 2005

A Food and Drug Administration advisory panel is scheduled to recommend today whether a drug aimed at treating high cholesterol should be sold from store shelves like common remedies for headaches, colds and allergies.

Merck & Co. and Johnson & Johnson, in a joint venture, have asked the FDA to let them sell a low-dose version of cholesterol-lowering Mevacor directly to consumers.

During the first day of a two-day hearing yesterday at a Bethesda, Md., hotel, FDA drug advisers questioned whether the pharmaceutical companies compiled enough evidence of Mevacor’s safety, such as for pregnant women.

“It seems to me the risk in humans has not been demonstrated,” said Alastair Wood, chairman of the advisory committee.

He noted that some of the toxicity tests were performed on rats. In human trials, there were “several cases of adverse pregnancy,” Dr. Wood said.

Potential problems include birth defects, he said.

Drug company officials said the risks were exaggerated at the 20 milligram dose that would be used for over-the-counter sales.

“We don’t believe there’s a significant risk at all,” said Edwin Hemwall, vice president for Johnson & Johnson/Merck.

Nevertheless, the companies agreed to label the drug containers with warnings against use by pregnant women, high-risk heart patients, small children and people with liver disease.

They also said they would do “post-marketing surveillance” to monitor any adverse reactions from over-the-counter sales.

Mevacor, one of a class of cholesterol-lowering drugs called “statins,” has been available by prescription since 1987. Merck lost patent protection on it in 2001, which led to generic sales of the drug.

Approval of over-the-counter sales would open the door for similar cholesterol-lowering drugs, such as Zocor and Pravachol, to be sold directly to consumers.

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

The drug companies say selling Mevacor over the counter would provide needed treatment to about 39 million Americans at moderate risk of heart disease who are not getting the medical assistance they need. Mevacor would sell for about $1 a pill per day.

“There is an enormous and growing cardiovascular public health problem that has not been adequately addressed,” said Dr. Richard Pasternak, vice president for clinical research for Merck Research Labs.

Last year, British health officials approved the world’s first nonprescription cholesterol drug, Zocor.

Opponents worry that patients taking the drugs will skip necessary doctor visits, where they might get important advice about diet and exercise.

In addition, patients taking the drug are supposed to get regular blood tests to make sure the cholesterol drugs are working and that the drugs are not causing liver damage.

Other people, who have little risk of heart disease, “may, nevertheless, be encouraged to use a statin because of its over-the-counter availability,” said Susan Sagusti, National Institutes of Health spokeswoman.

Allowing over-the-counter sales for Mevacor would put a new kind 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.

The hearing this week represents the second time the FDA has considered requests for statins to be sold over the counter.

In 2000, an advisory committee refused to recommend sales directly to consumers for Mevacor and Pravachol.

Historically, the FDA has followed recommendations from its advisory panels.

Mevacor is meant only for men 45 and older and women 55 and older whose LDL — low-density lipoprotein, or “bad” cholesterol — count is between 130 and 170. They also should 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.

This story is based in part on wire service reports.

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