FDA Warns Consumers About Common Off-Label Autism Therapy
http://www.forbes.com/sites/emilywillingham/2013/08/23/fda-warns-consumers-about-common-off-label-autism-therapy/
The FDA minces no words in its consumer alert about hyperbaric oxygen therapy :
No, hyperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes. But do a quick search on the Internet, and you’ll see all kinds of claims for these and other diseases for which the device has not been cleared or approved by FDA.
Evidently, the list of conditions HBOT purveyors have promised the therapy will treat is a long one and includes Parkinson’s disease, hepatitis, and multiple sclerosis, in addition to autism and cerebral palsy.
Of course, none of these conditions has been linked to a lack of access to oxygen for your tissues, which is the only indicated use of HBOT as a therapy. In fact, the FDA approves use of HBOT for 13 specific conditions, all of them related to helping boost the body’s access to oxygen. They include HBOT for carbon monoxide poisoning and for burns resulting from heat or fire.
Like any medical intervention, HBOT carries risks, according to the FDA, including mild effects such as ear pressure or sinus pain all the way to very serious adverse effects such as paralysis and embolisms. Oxygen, feeding fire the way it does [correction], also means a fire risk for anyone undergoing HBOT, which have been involved in about 80 deaths worldwide. Not something you want to do with any old street corner practitioner.
In addition to these risks, the FDA cautions that people turning to HBOT for autism or cerebral palsy or for cancer or Parkinson’s might well be delayed from receiving effective therapies and interventions while they waste time and money on HBOT.
Proponents of HBOT as a treatment for autism argue that the controversy around it is “political, not scientific.” But that’s not actually the case. In addition to the risks associated with HBOT, all of which at the least involve pain and discomfort, research suggests that the therapy is ineffectual, and the costs suggest that it’s enormously expensive for an unproven, “off-label” intervention that parents could just “try and see.”
From “Autism Speaks” ...
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FDA Cracks Down on False Claims about Autism Treatments
https://www.autismspeaks.org/science/science-news/fda-cracks-down-false-claims-about-autism-treatments
Agency issues consumer warning; threatens legal action against those who market unproven, potentially dangerous products and therapies.
“Autism Speaks and its many partners are working diligently to find treatments for autism that are safe and effective,” comments developmental pediatrician Paul Wang, Autism Speaks senior vice president and head of medical research. “We know that parents often are desperate to find help for their children. It’s tragic when unscrupulous companies take advantage of these families by pushing so-called treatments that are not only ineffective, but may be costly and dangerous.”
Though behavioral therapies don’t cure autism, research has demonstrated that several such programs can bring about real improvements in development and function, Dr. Wang adds. In addition, the FDA has approved two medications – risperidone and aripripazole – to treat severe self-injurious behavior and aggression associated with autism. These medications can have serious side effects and, so, are reserved for situations where behavioral approaches fail.