Cuban Cholesterol Drug Debunked



As with any treatment in which the only data comes from the manufacturer
and/or a totalitarian dictatorship, always wait for the independent random
clinical trial before buying into the myth. Which begs the oft asked
questions, So, just how many of Cuba's "triumphs" of biotechnology have gone
through enough scrutiny via independent random trials? How many have passed
and received market approval in the first world?

Film at 11

Sugar cane cholesterol treatment faulted

By LINDSEY TANNER
AP MEDICAL WRITER

CHICAGO -- German research casts doubt on the effectiveness of a sugar
cane-based ingredient sold as a cholesterol treatment in One-A-Day vitamins
and other products marketed in dozens of countries.

The substance, called policosanol, worked no better than dummy pills in
German adults with high levels of LDL cholesterol, the bad kind that can
clog arteries and lead to heart problems.

Even in high doses, policosanol derived from Cuban sugar cane produced no
meaningful changes in cholesterol levels during 12 weeks of treatment, said
lead author Dr. Heiner Berthold of the German Medical Association's drug
commission.

Most previous studies that reached the opposite conclusion were sponsored by
a company founded by Cuba's National Center for Scientific Research to
market policosanol, the German researchers said. The Cuban scientific center
didn't respond to requests for comment.

The German study involving 143 people appears in Wednesday's Journal of the
American Medical Association.

Patients were randomly assigned to get policosanol in various doses or dummy
pills for 12 weeks. There was no difference in the levels of LDL in
volunteers in either group.

Berthold, executive secretary of the German Medical Association's drug
commission, said his research doesn't rule out that policosanol might be
effective in different ethnic groups or that other formulations might have
different effects.

But he believes the product's claims have been overstated because there's no
"mechanism of action" to explain how it might lower cholesterol.

Policosanol is a combination of alcohols that come from plant wax. Cuban
sugar cane-based policosanol is sold in more than 40 countries, mostly as a
cholesterol treatment, the researchers said. Other sources for the
ingredient include wheat germ, rice, bran and beeswax. Policosanol products
are widely available on the Internet and in stores.

Bayer Consumer Care uses sugar cane-based policosanol in its One-A-Day
Cholesterol Plus vitamins and calls it "the leading complete multivitamin
specially formulated with heart-supporting nutrients."

Bayer spokeswoman Tricia McKernan said the study "was not designed to
address a claim that along with diet and exercise, policosanol can help
maintain healthy cholesterol levels already within the normal range."

"Bayer makes only the latter claim, and agrees with the authors that
consumers should always discuss their cardiovascular risk profile with their
doctor," McKernan said.

Policosanol is marketed in Cuba as a natural medicine called PPG with
purported benefits including lowering cholesterol levels, boosting energy
and weight loss.

Juventud Rebelde, the Communist Youth newspaper, reported last year that
about 250,000 people in Cuba take PPG and that it is exported to various
other countries.

Andrew Shao, vice president of scientific and regulatory affairs


NEW YORK (Reuters Health) - Policosanol, touted as a natural way to treat
high cholesterol levels, appears to be useless, German investigators report
in this week's Journal of the American Medical Association.

Policosanol is an extract of the waxy coating of sugar cane and other
plants, and multiple trials have demonstrated that it safely lowers lipid
levels. However, Dr. Heiner K. Berthold and his colleagues note that almost
all of these studies came from one group in Cuba, whose research was funded
by Dalmer Laboratories, which markets policosanol.

In an attempt to confirm their findings, Berthold, from the Drug Commission
of the German Medical Association in Berlin, and his team performed a
"rigorously controlled" multicenter study comparing Cuban sugar cane-derived
policosanol with an inactive "placebo" supplement.

Their study involved 143 Caucasian adults with LDL ("bad") cholesterol
levels of at least 150 milligrams per deciliter.


Participants were randomly assigned to policosanol at doses of 10, 20, 40 or
80 milligrams daily or placebo. After 12 weeks, the researchers saw no
statistically or clinically significant effect on LDL cholesterol at any
dose.

Similarly, the investigators report, there were no significant differences
among the groups in HDL ("good") cholesterol levels, total cholesterol, very
low density-cholesterol, triglycerides, or lipoprotein(a).

Berthold's team concludes that "more independent studies are required to
counterbalance the vast body of available positive trials." They also hope
to see trials showing patient-related outcomes, such as cardiovascular
illness and mortality.

The study was sponsored by Madaus AG, an international company specializing
in plant-derived drugs, which does not manufacture or distribute any
cholesterol-lowering drugs.

SOURCE: Journal of the American Medical Association, May 17, 2006.

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