- The Washington Times - Friday, January 14, 2005

A Food and Drug Administration advisory panel yesterday recommended against over-the-counter sales of a cholesterol drug, saying the risks of using it without a doctor’s supervision were greater than the health benefits.

The two pharmaceutical companies that want to sell the drug, Mevacor, presented evidence showing it could lower cholesterol and prevent heart disease when patients take one low-dose pill per day.

However, the FDA advisers by a 20-3 vote said patients need medical guidance to treat heart conditions with any drugs that could have side effects.

“The leap from prescription status to over-the-counter is a big one,” said Dr. Nelson Watts, a University of California doctor serving on the advisory panel. He voted against over-the-counter sales of Mevacor, one of a class of “statin” drugs.

Although the FDA is not bound by the panel’s recommendation, historically the agency has agreed with its advisers.

However, Dr. David S. Schade, a University of New Mexico doctor, said millions of Americans who lack adequate health care would get no treatment without the inexpensive over-the-counter sales.

“These people deserve the right to lower their risk and prevent cardiovascular disease,” Dr. Schade said.

A 20-milligram pill would sell for about $1.

Some panelists expressed concern that women might take Mevacor in early stage pregnancy and damage developing fetuses without knowing the risks.

High-risk heart patients, small children and people with liver disease also could be hurt by unsupervised use of the drug, according to doctors on the panel.

Mevacor, which would be sold by a joint venture of Merck and Johnson & Johnson, is intended only for patients with moderate risk factors, such as a mid-range cholesterol level and a smoking habit. Even then, they are supposed to take it before they show symptoms of heart disease.

Since it entered the market as a prescription drug in 1987, Mevacor has a history as a relatively safe drug. Since Merck’s patent on the drug expired in 2001, it has been sold generically by pharmaceutical companies.

The FDA denied a similar request in 2000 by the Merck-Johnson & Johnson joint venture to sell Mevacor over the counter.

Several panelists attacked the validity of tests by the companies showing Mevacor was safe and effective in lowering cholesterol. They said their studies used too few patients or failed to prove reduced risk of heart disease.

They also said some people with little risk of heart disease might take the drug unnecessarily. High-risk patients might take Mevacor when they need a higher-dose medication, they said.

“I don’t think the support system is in place to help patients make an informed decision,” said Dr. Paul Woolf, a doctor from Crozer Chester Medical Center in Upland, Pa.

The companies said yesterday they were disappointed by the decision but encouraged by the discussion and would work with the FDA toward getting the drug sold without prescription.

“We continue to believe in the benefits of Mevacor … as an over-the-counter medication to help lower cholesterol and contribute to improved overall public health,” said Merck/Johnson & Johnson spokesman Tony Plohoros.

The FDA has until Feb. 24 to decide whether to continue the drug’s prescription-only status.

Several panelists said they would like an option in which patients can buy the drug without a prescription but only after speaking with a pharmacist. The option is available in Britain, which last year began selling a similar drug, Zocor, under these rules.

FDA officials said they believe it would take a change in law to make that option available under FDA rules.

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 one-third. About $14 billion in statins were sold in the United States last year.

This story is based in part on wire service reports

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