FDA: Popular Autism Treatment 'Dangerous and Illegal'

(Oct. 15) -- Those desperate to treat chronic health conditions, including autism and heart disease, can buy chelation products online with a few clicks of the mouse.

But that might be changing, now that the Food and Drug Administration is launching a crackdown on the popular treatment, which the agency alleges is "dangerous and illegal" -- not to mention unproven to make any meaningful difference in the ailments it's purported to help heal.

The agency this week sent warning notices to eight purveyors of chelation products, which are not FDA approved for over-the-counter sales (that goes for Web-based transactions, too).

"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 statement. "The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief."

What is chelation?

It's a process that removes heavy metals from the body and is FDA approved under specific circumstances (like overexposure to lead or arsenic) and by prescription only. Approved chelation therapy is done intravenously, under doctor supervision.

Substances in chelation products bind with molecules, like those of metals, and then flush them from the body through urination.

Over-the-counter chelation products come as nasal sprays, liquids, capsules and even suppositories. They're often accompanied by heavy metal toxicity tests, which the FDA alleges yield positive results to compel patients to start chelating.

Why do patients use the products?

Parents of autistic children have been flocking to the therapy in growing numbers, based on the belief that the condition is caused by mercury toxicity.

Sufferers of other health problems, including Parkinson's and Alzheimer's, try chelation in an effort to "cleanse" the body of toxic substances. Most often, chelation therapies are marketed for conditions that are degenerative or have no known treatment.

But at least one serious ailment might actually benefit from chelation. The National Institutes of Health is studying the process for the treatment of heart disease, to see whether chelation can clear the arterial plaque.

What are the potential health risks?

FDA officials warn that chelation can lead to life-threatening dehydration, kidney problems and even permanent cognitive damage.

Not to mention that the therapy hasn't been proven to treat most of the conditions it's marketed for. And chelation might also lead to worsening symptoms, if patients swap out current medications for the alternative approach.

But FDA officials acknowledge that their knowledge of chelation's hazards is limited, largely because side effects go unreported.

"We don't have evidence of a lot of adverse events, but [that] does not mean there are not health problems associated with them," Charles Lee of the FDA's division of new drugs and labeling compliance said in a press release.

Where do chelation fans stand?

Those reached by the press say they plan to continue chelation therapy, and many parents of autistic children extol the treatment on message forums.

"The FDA is stupid," Ron Partain, a California pharmacist who's used chelation products for 15 years, told the Los Angeles Times. "We are not dangerous."

And some autism advocates, who think the condition is caused by heavy metal poisoning, claim the FDA is misrepresenting their community's approach to chelation therapy.

"Our organization agrees that if you are going to do something like chelation, you should do it with a doctor," Sallie Bernard, president of autism group SafeMinds, tells WebMD. "But the FDA made it seem that the autism community is engaged with these over-the-counter products and that is not the case. It is a slur against our community."

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