Rice Extract Lowers Cholesterol in Drug Unsuccessfully Challenged by FDA

March 25 1999

By Daniel Q. Haney

The Associated Press

A rice extract that was unsuccessfully challenged by the government because it closely resembles a prescription medicine has been shown to be a powerful means of lowering cholesterol.

The results of one of the first two U.S. studies of the substance, called Cholestin, were presented Thursday in Orlando at a medical conference sponsored by the American Heart Association. It showed that people with mildly elevated levels can drop their cholesterol about 35 points by taking four capsules of Cholestin a day.

Cholestin is made from red yeast that has been fermented on rice. Its chief ingredient is a naturally occurring form of lovastatin, a prescription cholesterol-lowering medicine.

In the Grey Area

Cholestin’s introduction in 1997 blurred the already fuzzy line between food supplements, which can be sold without a prescription, and drugs that require approval of the Food and Drug Administration. The FDA declared Cholestin to be an unapproved drug and attempted to block its sale. Cholestin’s manufacturer, Pharmanex Inc. of Simi Valley, Calif., sued and won. Last month, a federal judge in Salt Lake City ruled that Cholestin fits the definition of a dietary supplement and can stay on the market. The FDA has not said whether it will challenge that decision. Until now, all of the data on Cholestin’s health effects have come from China, where the rice extract has been used for centuries as a spice in such foods as Peking duck.

Test Done on 83 Volunteers

Last month, Dr. David Heber of the University of California at Los Angeles published a report in the American Journal of Clinical Nutrition on 83 volunteers. He found that eight weeks of Cholestin lowered their cholesterol an average of 17 percent. The latest study was directed by Dr. James Rippe of Tufts University School of Medicine in Boston and found similar results. Doctors in 12 medical practices across the country put 233 people on Cholestin for eight weeks. Their cholesterol levels fell from an average of 242 to 206. Both studies were financed by Pharmanex, and both Heber and Rippe are members of the company’s medical advisory board. "This is a promising new development worthy of further research," said Dr. Thomas A. Pearson of the University of Rochester, speaking for the heart association.

Part of ‘Overall Health Plan’

However, he cautioned against going on Cholestin without getting a doctor’s advice. "This should be integrated into the overall care plan," he said.

Lovastatin, sold by Merck Inc. as Mevacor, was the first of a powerful new class of cholesterol-lowering medicines known as statins. The smallest lovastatin pill on the market is 10 milligrams, while a daily four-pill regimen of Cholestin adds up to 5 milligrams of lovastatin.

Cholestin can be bought without a prescription, but the price is similar to Mevacor. A month’s supply of Cholestin costs about $30. A month of 40 milligram Mevacor pills costs about $150. But these pills can be cut into four pieces, bringing a 10 milligram-a-day dose down to $37 monthly.

Still, Rippe said many people may prefer Cholestin because it is a natural rather than synthetic form of the drug, and it offers one more option for those who need to lower their cholesterol.

"I’m not saying, `Eat a cheeseburger for lunch and than take Cholestin,"‘ he said. "It should be used in conjunction with exercise, diet and weight reduction."

Pharmanex’s sponsorship of scientific research to back up its health claims is relatively unusual among supplement makers. Another study nearing completion will look at the effects of Cholestin when eaten in a twice-daily power bar.

The company recently was bought by Nu Skin International of Provo, Utah. Nu Skin is withdrawing the supplement from chain drugstores and will sell it exclusively through mail order and independent pharmacies.