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Chelation Therapy Test Seeks Patients: NIH Looks into Controversial Treatment for Heart Disease

Posted on: Wednesday, 31 May 2006, 09:00 CDT

By Carla McClain, The Arizona Daily Star, Tucson

May 30--An unproven, highly controversial "alternative" treatment for severe heart disease is being tested in Tucson and nationwide under strict scientific rules.

The treatment -- known as chelation therapy -- uses an intravenous drug to pull toxic metals and the mineral calcium out of the body.

Most cardiologists remain skeptical of chelation. But some therapists say calcium deposits, and possibly high levels of metals in the blood, likely contribute to blocked arteries. They say they've seen patients benefit from having them removed.

Despite the controversy, hundreds of thousands of American heart patients have tried chelation in the past decade -- at a high cost, with no proof it works, and now some deaths linked to the drug.

As a result, scientists say it's time to find out if the therapy is safe and effective.

"Are we wasting their money, or is there something to it?" asked David Rupley, a homeopathic physician at the Coyote Healing Center in Tucson, one of 100 test sites in the United States for the five-year, $30 million trial sponsored by the National Institutes of Health.

Noting that a course of chelation therapy can cost a patient $4,000 to $6,000 out of pocket, he said: "We need answers for these people. The good news is this is a well-done study -- the first scientifically rigorous trial with enough patients to produce valid results."

Although the trial was officially launched nearly two years ago, recruitment of patients -- who must be 50 or older and have suffered a heart attack -- has been slow, with only two from the Tucson area joining so far, Rupley said.

Nationwide, the NIH wants a total of 2,300 patients enrolled at the 100 tests sites. At least another 1,000 patients are needed to complete the study.

Part of the problem may be the general doubt among doctors of chelation, making them reluctant to refer their heart patients to the study.

Even Dr. Andrew Weil -- a founder of the movement combining mainstream and alternative medical therapies, says he remains skeptical of chelation for cardiovascular disease.

"I have heard many testimonials from people who say they were helped by chelation, but just as many who say it did them no good at all," he writes on his Web site. "The NIH study should give us definitive answers. But until proved otherwise, my feeling is that the treatment is safe but ineffective (and expensive)."

Agreeing, the American Heart Association issued a statement on the issue last week, saying: "We find no scientific evidence to demonstrate any benefit from this form of therapy."

However, the AHA strongly backed the NIH clinical trial to settle the chelation question for good. The group points out that people who turn to an unproven therapy that doesn't work may decline standard proven treatment for coronary artery disease -- stopping smoking, controlling blood pressure and cholesterol with diet, exercise and medication, also more invasive procedures such as angioplasty, stents and bypass surgery.

But also possibly discouraging patients is the somewhat intensive nature of the trial. Patients will need to have some 40 infusions of the chelation drug -- on a weekly and bimonthly schedule, with each infusion lasting more than two hours.

And because the trial is placebo-controlled and blinded, some patients will get actual chelation, others will get inactive fluids and still others will get only vitamins. No one will know who gets what until the trial is over.

Finally, there is some concern about the chelation drug itself -- EDTA (ethylene diamine tetra-acetic acid), a synthetic amino acid, given intravenously, that binds with metals and minerals in the body, then excretes them in the urine.

At this point, EDTA is approved by the U.S. Food and Drug Administration only to treat lead poisoning and toxicity from other heavy metals. Raising some alarm were three deaths reported in March of patients given EDTA, who died of cardiac arrest after their blood calcium plunged.

Two of the deaths occurred in very young children being treated for lead poisoning, prompting the FDA to warn that this form of EDTA should never be used on children.

But the third death was of an apparently healthy 53-year-old woman having heavy metals removed from her body. As a result, the FDA "is performing a safety assessment" of EDTA, stated the report on these deaths done by the Centers for Disease Control and Prevention. That report mentioned the NIH heart disease trial using EDTA and did not raise any concerns about continuing the trial.

"The EDTA has to be given according to protocol," said Rup- ley, who added that there have been no deaths in the NIH trial.

"Problems can occur if you administer the mixture too quickly and drop the calcium levels too quickly," he said. "That is why we insist on taking nearly three hours for each infusion. This study must follow quite rigorous safety guidelines."

As a therapist who has treated heart patients with chelation, Rupley believes it has benefit.

"I have seen what appear to be miraculous results," he said, noting that he does not share his opinion with study patients.

In making the decision to launch this nationwide study, the chief investigator, Dr. Gervasio Lamas at Mount Sinai Medical Center in Miami, said: "I don't want to leave any stone unturned as we look for ways to address heart disease. And I don't think patients living with heart disease want us to either."

To learn more --Patients are being recruited to join the Trial to Assess Chelation Therapy, sponsored by the National Institutes of Health.

Candidates must be at least 50 years old and have had a heart attack. To ask about joining, call the Coyote Healing Center in Tucson at 722-9787.

For more information on the study, go to www.nc cam.nih.gov/chelation

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Copyright (c) 2006, The Arizona Daily Star, Tucson

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Source: The Arizona Daily Star

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