The United States government unsuccessfully challenged
the marketing and use a rice extract because it closely
resembles a prescription medicine. A U.S. study of the
substance, called Cholestin, showed that people with
mildly elevated cholesterol can lower their levels 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. It'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.nUntil recently, 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.
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.
Dr. David Heber of the University of California at Los
Angeles published a report in the American Journal of
Clinical Nutrition found that 83 volunteers using Cholestin
for eight weeks lowered their cholesterol an average of 17
percent. Another study, directed by Dr. James Rippe of
Tufts University School of Medicine in Boston found similar
results. Doctors in 12 medical practices across the country
put 233 people on Cholestin for eight weeks. Cholesterol
levels fell from an average of 242 to 206.
"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. However,
he cautioned against going on Cholestin without getting a
doctor's advice. "This should be integrated into the
overall care plan," he said.
The prescription drug 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 does not need a
prescription, but the price is similar to Mevacor. A
month's supply of Cholestin costs about $30, while 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."