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Feds To Probe Study Of Alternative Heart Disease Treatment

June 10, 2009

Government investigators are again turning to heart attack survivors, enrolling them in a controversial new study of an alternative treatment of high dose vitamin supplements and chelation, a lead poisoning treatment that has not been proven safe or effective for heart disease.

The $30 million experiment is one of the largest alternative medicine studies ever conducted, with 1,500 participants enrolled to date.

But enrollment was suspended last August, when the federal Office of Human Research Protections began a probe into whether participants were being fully informed of the risks and sufficiently protected.

The chelation that will be used in the study involves intravenous doses of the drug disodium EDTA, which advocates say can remove calcium that has accumulated in artery walls creating clogged or stiff arteries that can cause heart problems.  These problems are treated today with conventional methods such as surgery, medicines and angioplasty.

At the study’s inception in 2002, researchers sought to enlist 2,400 people at more than 100 sites in the U.S. and Canada.   However, recruitment fell short, and investigators now hope to enlist at least 1,700.

Several scientists published an article last year that was critical of the study, and complained to the federal research protection office.   They pointed to the study’s consent form, which does not inform participants that others have died from chelation.  Furthermore, there are conflicts of interest, they say, since more than half of the doctors conducting the study make money by selling chelation treatments.

The federal agency found enough merit in the complaint to open a probe of the study, which is being sponsored by the National Heart, Lung and Blood Institute and the National Center for Complementary and Alternative Medicine.

“That investigation is still ongoing,” spokeswoman Pat El-Hinnawy told the Associated Press.

Dr. Gervasio Lamas, the study’s leader, and other researchers voluntarily suspended enrollment in the study last fall.   But most sites resumed in January, according to a spokeswoman for the National Heart, Lung and Blood Institute.

Lamas is now with Mount Sinai Medical Center in Miami Beach, Florida, having recently left the University of Miami’s Miller School of Medicine.

Chelation (pronounced kee-LAY-shun) has been extremely controversial, and many groups, including the American Heart Association, have spoken out in opposition to it.

“EDTA isn’t totally safe,” and carries a risk of kidney failure, shock, bone marrow problems, convulsions, low blood pressure, heart rhythm problems, allergic reactions and breathing troubles, the association wrote on its Web site.

The U.S. Food and Drug Administration, two leading doctor groups and others have called chelation experimental, saying it carries unknown risk or value for those with heart disease.

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