‘Natural’ statins vary in quality, study finds

* Supplements varied in active ingredient

* One-third tainted with potential cancer-causing toxin

By Maggie Fox, Health and Science Editor

WASHINGTON, Oct 25 (BestGrowthStock) – Red yeast rice supplements,
sold as a “natural” alternative to cholesterol-lowering statin
drugs, vary widely in how much active ingredient they contain
and some are contaminated, U.S. researchers reported on
Monday.

Americans thinking they are getting a reliable and safe
alternative to prescription drugs should take a closer look,
and regulators should consider stricter limits on the products,
Dr. Ram Gordon of Chestnut Hill Hospital and the University of
Pennsylvania and colleagues said.

They tested 12 commercially available products and found
great variation in how much active ingredient each actually
contained.

“One-third of the products tested were contaminated
with citrinin,” they wrote in the Archives of Internal
Medicine. Citrinin is a so-called mycotoxin that can alter DNA,
which means it could potentially cause cancer.

Red yeast rice contains 14 active compounds called
monacolins that slow the liver’s production of cholesterol.

Each of the 12 products tested was labeled “600 mg/capsule”
of active product.

“Although statins and other proven prescription
lipid-lowering therapies have been available for decades,
many patients seek alternative therapies to lower their
cholesterol levels,” the researchers wrote.

The first statin, lovastatin, was in fact based on red
yeast rice.

In 1998, the U.S. Food and Drug Administration ruled that a
product called Cholestin was not a dietary supplement but an
unapproved drug — in essence, a source of lovastatin. Maker
Pharmanex, now a subsidiary of Nuskin (NUS.N: ), removed red
yeast rice from Cholestin.

$20 MILLION MARKET

But consumers may be getting statins from the supplements
anyway.

“In 2008, American consumers spent $20 million on this
dietary supplement, an 80 percent increase compared with 2005,”
the researchers wrote, citing the Nutrition Business Journal.

“However, to avoid being considered an unapproved drug by
the FDA, red yeast rice manufacturers typically do not disclose
levels of lovastatin or other monacolins in their products, and
there is no standardization of these levels across
manufacturers.”

Some of the products they tested included 21st Century 100
percent Vegetarian Red Yeast Rice Extract from 21st Century
Healthcare in Tempe, Arizona, and Schiff New Red Yeast Rice
from Schiff Nutrition Group in Salt Lake City, Utah.

The researchers did not say which products had the highest
or lowest levels of active ingredients and which were
contaminated.

The health implications are clear, they said.

“Most Americans perceive naturally derived products as safe
and as effective as regulated pharmaceuticals and about 60
percent of patients do not reveal the use of dietary
supplements or alternative medications to their health care
providers,” they wrote.

They said anyone taking the supplements should tell their
doctors, as statins can have serious side-effects including
muscle breakdown.

The $20 million market for the supplements is a small dent
in the overall market for statins, the world’s best-selling
drugs. Consumer Reports estimates the U.S. market for statins
to be $14 billion.
(Editing by Jim Marshall)

‘Natural’ statins vary in quality, study finds