The Chelate Debate

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The government's National Committee for Complementary and Alternative Medicine recently announced that it may fund a five-year-long, large-scale study evaluating the possible benefit of chelation treatment for those suffering from heart disease. At first, this may sound like a reasonable inquiry. Why wouldn't we want to consider all possible options for the treatment of the number one killer in America? Just last year, almost 62 million Americans had some form of cardiovascular disease (CVD) and nearly one million died of related conditions. The problem lies in the fact that chelation therapy has been investigated for the last forty years and in that time, no practitioners have been able to prove its efficacy while dozens of reports by mainstream scientists have failed to find any efficacy. The National Institutes of Health (NIH) are investing their money (actually, our money $30 million, to be exact) in something that has been shown to be no more effective than a saltwater placebo.

Chelation was first used to treat lead poisoning and to rid the body of excessive amounts of heavy metals. The process involved administering the man-made amino acid ethylenediaminetetraacetic acid (EDTA) into the bloodstream, either through a vein or orally (a delivery method no longer used), thereby binding metals from the blood. When bound to EDTA, they become soluble and are excreted in urine. EDTA can also bind calcium, which is found in arterial plaque, and this is what first led to the presumption that it could be used to remove calcium build-up in arteries and prevent further build-ups from forming. This presumption was eventually proven wrong since EDTA can't cross into cells and since there is no clear connection between calcium and plaque formatin as reported by Dr. Saul Green in his article "Chelation Therapy: Unproven Claims and Unsound Theories." As Green notes, chelation proponents have "invoked various biochemical mechanisms to justify their use of EDTA chelation" since then, but all have eventually been disproven by sound science.

Chelation has never been clinically demonstrated to help those with heart disease or other vascular diseases by independent, objective investigations. Advocates cite thousands of cases and studies, all anecdotal, but these reports have been published in obscure journals and have never undergone a rigorous peer review process. Also, nearly all positive findings are from observational studies, which are anecdotal and highly subjective. Without a control group, it is difficult to ascertain which findings can be attributed to chelation therapy and which to other influencing factors. As explained by the American Heart Association, one-third of CVD deaths can be thwarted through regular exercise and a good diet. Chelation with EDTA requires patients to make lifestyle changes, such as smoking cessation, weight loss, regular exercise, and the adoption of healthy, low-fat, high-fiber diets, which all have positive health effects of their own. Therefore, the seemingly positive findings in these observational studies are most likely a result of the improved lifestyle habits of patients and not the chelation therapy itself.

There have been some well-designed studies with blind, randomized conditions and control groups that have investigated chelation. The most recent and most rigorous study to date on chelation was published in the Journal of the American Medical Association in January. Its methodology a double-blind, randomized, placebo-controlled trial was the very best for deciding once and for all whether chelation therapy is an effective treatment. After following eighty-four participants for four years, the investigators concluded: "There is no evidence to support a beneficial effect of chelation therapy in patients with ischemic heart disease, stable angina, and a positive treadmill test for ischemia."

In 2000, a review was published in the American Heart Journal that summarized all clinical investigations of chelation therapy, both controlled and uncontrolled, noting: "The most striking finding is the almost total lack of convincing evidence for efficacy...Only two controlled clinical trials were located [in searches of the literature]. They provide no evidence that chelation therapy is efficacious beyond a powerful placebo effect...Given the potential of chelation therapy to cause severe adverse effects, this treatment should now be considered obsolete."

Just because chelation is touted as a non-invasive alternative doesn't mean it's without risk. There have been reports of kidney failure, liver damage, blood coagulation problems, bone marrow depression, shock, low blood pressure, convulsions, cardiac arrhythmias, allergic reactions, respiratory arrests, low levels of calcium, hypoglycemia, and even a number of deaths in the United States. There is also a danger in relying on this unproven "cure," which leads some to delay the use of proven therapies, such as drugs and surgical procedures, until it's too late.

It's not that the jury is still out on whether or not chelation is effective the jury has already decided, and this is what the authorities have said:

  • The American Heart Association: "The AHA has reviewed the available literature on using chelation to treat arteriosclerotic heart disease. We found no scientific evidence to demonstrate any benefit from this form of therapy."
  • The Food and Drug Administration: "No party has ever provided us with an organized submission attempting to show that it is an effective therapy in atherosclerosis; instead, we have been handed unorganized data without any attempt to describe a formal study. Under the circumstances, we have had no choice but to attempt to prevent improper promotion of the drug and to point out its unproven status."
  • The National Heart, Lung, and Blood Institute, part of the National Institutes of Health, which is actually funding the $30 million chelation study: "There is no reason to expect benefit from chelation in the management of arteriosclerosis. More importantly, there has been no scientific evidence of such benefit and there is scientific evidence of no benefit."

Chelation advocates argue that the medical establishment feels threatened by chelation and its ability to effectively treat patients, taking away from the profits made by drug companies who make cholesterol-lowering drugs and surgeons who perform angioplasty and bypass surgeries.

Dr. Elmer Cranton, in his article "Busting the Quackbusters: Rebuttal to 'Quackwatch' Website Opposing Chelation Therapy," commented: "The bypass surgery and balloon angioplasty industries gross upwards of $6 billion dollars per year. If the existing studies of chelation therapy were to be accepted as valid, those industries would suffer enormous losses. They have no reason to want to see chelation therapy accepted."

On the other hand, chelation also is quite expensive: Initial treatment costs between $3,000 and $5,000, with regular monthly follow-up preventive treatments recommended. Millions of people have atherosclerosis, and if chelation actually worked, physicians could greatly profit from administering an easy procedure to large numbers of patients rather than focusing their energy on the small number of patients who have problems severe enough to require time-consuming bypass surgery or angioplasty.

Cardiovascular disease will continue to afflict millions of people each year, accounting for four out of every ten deaths. The American Council on Science and Health's recent report, Chemoprevention of Coronary Heart Disease, found that people can reduce their risk of heart attack by about 30% with the use of cholesterol-lowering drugs good news for the nearly 100 million Americans with high cholesterol. Furthermore, over 550,000 bypasses were performed in 1998, saving thousands of lives. However, not all individuals have access to these effective drugs, and bypass is still a major invasive operation. The American public could greatly benefit from the government supporting the further development of existing, proven therapies, rather than directing $30 million dollars to the study of something that the NIH itself proclaimed has no scientific evidence backing its efficacy and safety.

We need to invest our public health funds in effective programs that can actually save lives and let the chelate debate die.

Karen Schneider is a research intern at the American Council on Science and Health.