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FDA cracks down on misleading claims about autism therapies

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Hyperbaric Oxygen Therapy involves breathing oxygen in a pressurized chamber and has been cleared by FDA for certain medical uses, such as treating decompression sickness suffered by divers.

The U.S. Food and Drug Administration (FDA) issued a consumer update recently in which it announced it was going to “crack down” on deceptive claims about autism therapies.

The agency says it has put several companies on warning that “they are facing possible legal action if they continue to make false or misleading claims about products and therapies claiming to treat or cure autism.”

As the FDA update points out, there is no cure for autism, a neurobehavioral disorder that affects an estimated 1 in 68 children in the United States, so any products or treatments that offer such a cure are fraudulent. The same is true, the agency adds, for some of the products that claim to “treat” autism.

Focus on five misleading ‘treatments’

Here are five of the so-called therapies that the FDA is targeting:

  • “Chelation Therapies.” These products claim to cleanse the body of toxic chemicals and heavy metals by binding to them and “removing” them from circulation. They come in a number of forms, including sprays, suppositories, capsules, liquid drops and clay baths. FDA-approved chelating agents are approved for specific uses, such as the treatment of lead poisoning and iron overload, and are available by prescription only. FDA-approved prescription chelation therapy products should only be used under medical supervision. Chelating important minerals needed by the body can lead to serious and life-threatening outcomes.
  • Hyperbaric Oxygen Therapy. This involves breathing oxygen in a pressurized chamber and has been cleared by FDA for certain medical uses, such as treating decompression sickness suffered by divers. It has not been cleared for autism, among other conditions.
  • Miracle Mineral Solution. Also known as Miracle Mineral Supplement and MMS, this product becomes a potent chemical that‘s used as bleach when mixed according to package directions. FDA has received reports of consumers who say they experienced nausea, severe vomiting and life-threatening low blood pressure after drinking the MMS and citrus juice mixture.
  • Detoxifying Clay Baths. Added to bath water, these products claim to draw out chemical toxins, pollutants and heavy metals from the body, falsely offering “dramatic improvement” for autism symptoms.
  • CocoKefir probiotics products. Product claims include being a “major key” to recovery from autism, but they are not proven safe and effective for this advertised use.

How to spot possible fraud

The FDA also provided a few basic tips to parents of autistic children who are trying to determine whether a particular treatment is fraudulent:

  • Be suspicious of products that claim to treat a wide range of diseases.
  • Personal testimonials are no substitute for scientific evidence.
  • Few diseases or conditions can be treated quickly, so be suspicious of any therapy claimed as a “quick fix.”
  • So-called “miracle cures,” which claim scientific breakthroughs and secret ingredients, may be a hoax.

Long history of failed treatments’

The Association for Science in Autism Treatment (ASAT), which describes itself as “a not-for-profit organization of parents and professionals committed to improving the education, treatment, and care of people with autism,” offers its own (and much longer) list of the “warning signs” of pseudoscientific therapies.

The ASAT also provides detailed evidence-based research summaries of psychological, educational and therapeutic interventions for children and adults with autism.

“Since autism was first identified, there has been a long history of failed treatments and fads, levied on vulnerable individuals as well as on their families,” the ASAT’s website notes. “From the scandal of the ‘refrigerator mother’ theory, to the ongoing parade of ‘miracle cures’ and ‘magical breakthroughs,’ history has been dominated by improbable theories about causation and treatments. Many of these treatments have been too quickly adopted by professionals, too readily sensationalized by the media, and too hastily embraced by hopeful consumers — well before supporting evidence or reasonable probability existed for their effectiveness or safety.”

Let’s hope the the FDA’s latest efforts to crack down on fraudulent claims regarding autism treatments have some effect.

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