Cholesterol medications found lacking
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KAI RYSSDAL: The government can regulate markets all it wants, but if investors want to sell, they’re going to sell. Shares of Merck and Schering-Plough hit record lows today. Traders dumped the drug makers after news yesterday about a cholesterol-lowering medication they made and marketed together. The drugs lowered cholesterol all right, but they didn’t do much for other symptoms of heart disease, and might make them worse.
Marketplace’s Nancy Marshall Genzer reports.
VYTORIN COMMERCIAL: Cholesterol comes from two sources, food and family. Vytorin treats two sources.
NANCY MARSHALL-GENZER: Sounds good, doesn’t it? When Vytorin and Zetia came on the market, they were heralded as the new miracle drugs for lowering cholesterol. Lots of people saw that ad. They asked their doctors for the new drugs. Last year, sales climbed to more than $4 billion, and that’s just in the U.S.
HARLAN KRUMHOLZ: There was quite a lot of what you could call maybe even call it irrational exuberance for this drug.
That’s Yale cardiologist Harlan Krumholz. He was on the panel that issued a report on the drugs yesterday. Krumholz says the problem with Vytorin and Zetia is, while they lower cholesterol, they don’t do anything about the plaque in arteries that can cause strokes and heart attacks. So why are we just finding out about this out now? Cardiologist Steven Nissen of the Cleveland Clinic says the Food and Drug Administration has given fast-track approval to drugs without requiring extensive studies.
STEVEN NISSEN: With very aggressive marketing, physicians have been led to prescribe these drugs without ever having the necessary data on things like heart attack, stroke.
But Doctor Nissen says Congress has given the FDA new powers. Now it can require more drug safety studies, and issue fines if drug makers don’t disclose the results of studies gone awry.
NISSEN: There’s a lot of power there for the agency to require pharmaceutical companies to keep us informed about safety issues with drugs, and there certainly are greater enforcement powers.
The question is, how the FDA uses those powers. Sometimes drugs need to be fast-tracked, say for life-saving medications.
In Washington, I’m Nancy Marshall Genzer for Marketplace.
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