Cholesterol Pill In, Resin Out

FDA Approves Drug, But Folk Remedy Guggul Gets Bad Marks In Study

(CBS/AP)  A popular folk remedy made from a tree resin might have dangerous effects on cholesterol levels despite laboratory experiments suggesting otherwise, a study found.

The research focused on pills made from a resin extract called guggul — a medicine taken for centuries in India.

Meanwhile, the Food and Drug Administration has approved a cholesterol-lowering drug called Crestor after long debate about the risk of side effects.

Made by AstraZeneca Pharmaceuticals, Crestor is the sixth choice in the popular family of drugs called statins that lower cholesterol and reduce the risk of heart attacks.

Patients who took the guggul pills daily for eight weeks showed slight increases in low-density cholesterol, the bad kind. Six of the 67 patients who took the pills also developed an itchy red skin rash over much of their bodies.

"Based on these data, I discourage people ... from using guggul to manage their cholesterol because there are plenty of proven safe and effective therapies currently on the market," said lead researcher Philippe Szapary of the University of Pennsylvania.

His study appears in Wednesday's Journal of the American Medical Association.

Research published last year in Science magazine's electronic edition suggested guggul might be effective at controlling cholesterol levels. That research, by molecular biologist David Moore and colleagues at Baylor College of Medicine in Houston, involved lab experiments in mice and showed that guggul could control cholesterol levels.

Szapary's research involved 103 Philadelphia-area adults with high cholesterol. They were divided into groups who took daily doses of dummy pills; a standard 1,000-milligrams of guggul-containing pills; or 2,000 milligrams of guggul pills.

Low-density cholesterol levels rose an average of nearly four points in the standard-dose guggul group and nearly five points in the high-dose group. They dropped an average of almost five points in the dummy-pill group — likely because of the "placebo effect," Szapary said. That refers to benefits patients on placebo pills sometimes get simply because they think they are taking real, effective medicine.

The Food and Drug Administration approved Crestor Tuesday because it may be a little more potent than some competitors, even though it comes with some warnings.

Having another drug option is important, as not everyone gets optimal cholesterol-lowering results from today's drugs, said FDA's Dr. Robert Meyer, who oversaw the agency's evaluation of Crestor.

In one study of 2,200 patients, those taking Crestor saw levels of the so-called "bad cholesterol," the LDL type, drop somewhat more than those given other statins, AstraZeneca said.

In 2002, sales of cholesterol drugs exceeded $17 billion, Decision Resources, a Waltham, Mass.-based pharmaceutical industry research firm, told CBS MarketWatch. Pfizer's Lipitor alone generated nearly $8 billion last year, a record for the pharmaceutical industry.