FDA Panel Nixes Over-The-Counter Sale of Cholesterol Drug

Advisers cite need for medical supervision when taking statins

Please note: This article was published more than one year ago. The facts and conclusions presented may have since changed and may no longer be accurate. And "More information" links may no longer work. Questions about personal health should always be referred to a physician or other health care professional.

By
HealthDay Reporter

FRIDAY, Jan. 14, 2005 (HealthDayNews) -- A U.S. Food and Drug Administration advisory committee voted Friday against recommending the over-the-counter sale of the cholesterol-lowering drug Mevacor.

After two days of hearings, the committee members voted 20-to-3 to reject Merck & Co.'s application, saying the company hadn't proven consumers could safely use Mevacor (lovastatin) without a doctor's advice.

"The information is too complex to dumb down," said Ruth Parker, an Emory University School of Medicine professor who serves on the 25-member committee, according to a Bloomberg news report. "The task is to take something as complex as this and make it something that the ordinary citizen can understand."

Merck's key study for an over-the-counter use of the drug was a trial involving more than 3,000 participants that was known as "CUSTOM." It showed that without a doctor's supervision, many patients without high cholesterol thought they should take the drug and others used it improperly, said panel member Paul Woolf, chairman of the department of medicine at Crozer-Chester Medical Center in Upland, Pa.

"The CUSTOM study was a failed study," Woolf told Bloomberg. "I don't think it was convincing at all."

This is the second time the panel has recommended against allowing Merck and Johnson & Johnson, who had hoped to market a low-dose, 20-milligram version of Mevacor as a joint venture, to sell the drug over-the-counter. The first time the panel voted against the measure was in 2000.

The vote by the Endocrinologic/Metabolic and Non-Prescription Drugs Advisory Committee is the last step before full FDA action. The FDA generally follows the recommendations of its advisory committees.

According to a news release from the advisory committee, many members said they would have voted for nonprescription status had there been a behind-the-counter option, as is done with Zocor in England. In that setting, the drug is placed behind the pharmacy counter, and a person must speak to a pharmacist before buying the drug.

Mevacor belongs to a class of drugs called statins, which have been effective in reducing levels of LDL cholesterol, which can clog arteries. Millions of people in the United States are currently taking statins, with the hope that by reducing cholesterol, the risk of heart attacks and stroke will be reduced as well.

The vote was good news for a number of groups that testified against allowing Mevacor to be dispensed without a prescription.

"Most of the people who would self-select to get the drug cannot possibly benefit because they are not in an adequate risk category, which means that they are getting a drug that has some risk, and they are getting zero benefit," said Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group.

Even for people who are at risk for a heart attack, there is no evidence the drug has a clinical benefit, Wolfe said. In addition, he objected to the implied message that allowing the drug to be sold over-the-counter would send.

That message is: "Doing things to improve your health like dieting and exercise can be substituted for by an over-the-counter pill," Wolfe said. "Especially the people who would self-select this drug could benefit from diet and exercise. If instead they choose to use a pill that cannot benefit them, that's a huge public health tradeoff in the wrong direction."

"Existing models for over-the-counter availability do not provide the safeguards required to ensure the safe and effective use of statins as part of a multifaceted approach to preventing coronary heart disease," the Society of Health-System Pharmacists said in a prepared statement.

And Dr. Nancy Green, medical director of the March of Dimes, said, "We are very pleased by the FDA advisory committee. It was a well-informed decision not to allow lovastatin to be sold over-the-counter."

Before any drug is sold over-the-counter, there needs to be an analysis of the impact that it might have on pregnant women, Green said. "This is true for women who know they're pregnant and for women who might become pregnant while taking it or who are taking it and don't know they're pregnant," she added.

The companies wanting to sell Mevacor over-the-counter were not pleased with the FDA decision, however.

"Johnson & Johnson Merck is disappointed with the outcome of the deliberations on the FDA's The Endocrinologic/Metabolic and Non-Prescription Drugs Advisory Committees," said spokesman Tony Plohoros. "We are encouraged by the discussion and recognize the vote of the committees reflected a wide range of opinions."

More information

The American Heart Association can tell you more about cholesterol.

SOURCES: Sidney M. Wolfe, M.D., director, Public Citizen's Health Research Group, Washington D.C.; Nancy Green, M.D., medical director, March of Dimes, White Plains, N.Y.; Tony Plohoros, spokesman, Johnson & Johnson Merck, Whitehouse Station, N.J.; Jan. 14, 2005, statement, Society of Health-Systems Pharmacists; Bloomberg news; Jan. 14, 2005, release, FDAadvisorycommittee.com

Last Updated: