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Users of Cholesterol-Reducing Drug Will Still Need a Prescription

Posted on: Friday, 14 January 2005, 21:00 CST

Jan. 15--Government advisers Friday recommended against a proposal to allow a statin cholesterol-reducing drug to be sold without a prescription.

The Food and Drug Administration advisory panel voted, 20-3, against allowing Mevacor to be sold over the counter. A joint venture of two New Jersey drug makers -- Merck and Johnson & Johnson -- applied for the switch.

The FDA has final say on the application but usually follows its advisers.

Such cholesterol-reducing statins as Lipitor and Zocor are among the nation's most widely prescribed drugs. Proponents of over-the-counter Mevacor said that easier access could go a long way toward preventing heart disease.

Mevacor would be an unusual OTC drug because it doesn't treat obvious symptoms, such as headaches or heartburn, and the only way to know if one has high cholesterol is through tests.

Advisers at the meeting said patients need medical guidance in treating high cholesterol. The panel raised concerns about how well people could use it on their own.

"The information is too complex to dumb down," adviser Ruth Parker, an Emory University School of Medicine professor, said during the meeting that began Thursday in Bethesda, Md.

Advisers expressed concern that in studies simulating over-the-counter sales, most of the people who chose to take Mevacor didn't meet the requirements of the label. Some people were not at high enough risk of heart disease to need the drug -- they were too young, for instance, or their cholesterol levels weren't high enough. In other cases, their risk of heart disease was so high that they should be seeing a doctor and possibly receiving a stronger drug.

At a similar meeting in 2000, FDA advisers also voted against moving Mevacor over the counter. Since then, national cholesterol guidelines increased the number of people who should be taking cholesterol drugs. Also, Merck and J&J upped the dosage on the proposed OTC Mevacor to answer concerns that it wouldn't provide enough benefit, and the companies sponsored a study, called "Custom," to provide evidence for the switch.

"The Custom study was a failed study," said panel member Paul Woolf, chairman of the department of medicine at Crozer-Chester Medical Center in Upland, Pa. "I don't think it was convincing at all."

A spokesman for Bristol-Myers Squibb Co., which in December announced it would seek approval of an over-the-counter version of its Pravachol statin, said Friday the company is continuing to pursue an OTC switch, and that studies are under way to support such a move.

Merck vowed to work with the FDA in hopes of eventually selling Mevacor over the counter.

However, Andrew Oh, an analyst with Leerink Swann, said in a note to investors after the vote Friday that approval of any OTC statin is "highly unlikely."

British authorities last summer approved a non-prescription version of Zocor, but that country has provisions for drugs to be sold after speaking with a pharmacist. Several members of the panel said Friday they would like to see such an in-between option.

This article contains news service material.

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(c) 2005, The Record, Hackensack, N.J. Distributed by Knight Ridder/Tribune Business News. For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail reprints@krtinfo.com.

MRK, JNJ, BMY,

Source: The Record - Hackensack, New Jersey

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