FDA Comes Down on Chelation as Untested Autism Treatment

A commentary on claims that chelation is a treatment for autism.

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Chelation is a legitimate medical treatment for heavy metal poisoning, but there's no evidence that it treats autism, heart disease, Alzheimer's, and other serious conditions. Despite that, chelation is heavily marketed on the Internet and by "alternative" physicians and pharmacists as a cure. The U.S. Food and Drug Administration just slapped the hands of eight companies for marketing chelation as a medical treatment for autism, saying that the treatments could be dangerous, and could also keep people from using therapies that are safe and effective.

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"These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options," Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in a press release. "The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief."

Chelation chemicals are approved for treating poisoning with lead and other heavy metals; they bind to the metals in the body, and are then excreted in urine. But chelation chemicals also can cause serious harm, including kidney failure and death. In 2005, a 5-year-old boy died of a heart attack while being treated with chelation for autism by a Pennsylvania physician. The physician was sued by the child's parents, and his medical license was suspended for three years.

And there's no evidence that chelation even works for autism; the treatment is based on the unproven theory that children with autism have heavy-metal poisoning. A 2008 study that evaluated the quality of research on various autism treatments gave chelation the lowest possible grade, saying there are no controlled trials on the safety and effectiveness of chelation as an autism treatment. (Behavioral therapies like applied behavior analysis are considered the best-researched option for treating autism.) That same year, the National Institutes of Health canceled plans to run a clinical trial on chelation for the treatment of autism in children, saying the risks outweighed any potential benefit.

There are many "success" stories about treating autism with chelation on the Internet. They are heartwarming, but don't provide reliable evidence because they are reported either by parents eager to see improvement in a beloved child, or by practitioners selling the treatments.

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The NIH is continuing with a $30 million trial of chelation as a treatment for coronary artery disease in adults, a large study with 1,600 participants. (Clinical trials for adults are held to less stringent safety standards than are those for children.) Proponents of chelation for heart disease say the chemical binds to calcium in arterial plaque, sweeping away the plaque and opening vessels. But there's no evidence that happens. Results of that trial are expected in 2012. That study won't provide much-needed evidence on the safety and effectiveness of chelation for autism, but it may help parents make better-informed decisions on their children's care.