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Beware of False or Misleading Claims for Treating Autism
FDA Cracks Down on False Claims
April is National Autism Awareness Month, a fitting time to think about the growing need for concern and awareness about autism.
One thing that is important to know up front: There is no cure for autism. So, products or treatments claiming to “cure” autism do not work as claimed. The same is true of many products claiming to “treat” autism. Some may carry significant health risks.
The Food and Drug Administration (FDA) plays an important role in warning these companies against making false or misleading claims.
About Autism
According to the Centers for Disease Control (CDC), about 1in 68 children has been identified with an autism spectrum disorder (ASD). ASDs are reported to occur in all racial, ethnic and socioeconomic groups, and are almost five times more common among boys (1 in 54) than among girls (1 in 252).
The National Institutes of Health (NIH) describe autistic children as having difficulties with social interaction, displaying problems with verbal and nonverbal communication, exhibiting repetitive behaviors and having narrow, obsessive interests. These behaviors can range in impact from mild to disabling.
“Autism varies widely in severity and symptoms,” says Amy Taylor, M.D., M.H.S., a pediatrician at FDA. “Existing autism therapies and interventions are designed to remedy specific symptoms and can bring about improvement,” she adds.
In addition, FDA has approved medications that can help some people manage related symptoms of ASD. For example, the FDA has approved the use of antipsychotics such as risperidone and aripripazole to treat children 5 or 6 years of age and older who have severe tantrums or aggression and self-injurious behavior. Before using any behavioral intervention or drug therapy (prescription or over-the-counter), check with your health care professional.
The Association for Science in Autism Treatment (ASAT), a not-for-profit organization of parents and professionals committed to improving the education, treatment, and care of people with autism, says that since autism was first identified, there has been a long history of failed treatments and fads.
FDA Cracks Down on False Claims
According to Gary Coody, R.Ph., FDA’s national health fraud coordinator, the agency has warned a number of companies 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. Some of these so-called therapies carry significant health risks and include:
— “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.
— Coconut kefir and other probiotic products. These marketed products claim to treat autism and gastrointestinal illnesses associated with autism. They have not been proven safe and effective for these advertised uses.
Coody offers some quick tips to help you identify false or misleading claims.
- 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.
The bottom line is this—if it’s an unproven or little known treatment, talk to your health care professional before buying or using these products.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm394757.htm
Hyperbaric oxygen in the treatment of childhood autism: a randomised controlled trial.
Sampanthavivat M1, Singkhwa W, Chaiyakul T, Karoonyawanich S, Ajpru H.
Abstract
BACKGROUND:
Promising results with hyperbaric therapy for children with autism have been reported, but most involved the use of only mild pressure with oxygen supplementation. To date, there has been no randomised, blinded trial of 100% oxygen administered at hyperbaric pressure. This study evaluated the efficacy of hyperbaric oxygen therapy (HBOT).
METHODS:
Sixty Thai children with autism, aged three to nine years, were randomly assigned to receive 20 one-hour sessions of either HBOT at 153 kPa (1.5 ATA) or sham air at 116 kPa (1.15 ATA). Effects on behaviour were measured using the Autism Treatment Evaluation Checklist score (ATEC) and clinical improvement was measured with the Clinical Global Impression (CGI) system; in particular the clinical change (CGIC) and severity (CGIS) sub-scores. These were evaluated by parents and clinicians, both of whom were blinded to the actual exposure.
RESULTS:
The mean total ATEC scores by both parents and clinicians were significantly improved after intervention in both arms of the study compared to the score before intervention (P < 0.001 in both groups by parents, P = 0.015 in HBOT group and P = 0.004 in sham group by clinician). There were no statistically significant differences in average percentage changes of total ATEC score and all subscales scores when comparing the HBOT and sham air groups, either by parents or clinicians. Changes in the CGI scores following intervention were inconsistent between parents and clinicians. For severity scores (CGIS), parents rated their children as more improved following HBOT (P = 0.005), while the clinicians found no significant differences (P = 0.10). On the other hand, for change scores (CGIC) the clinicians indicated greater improvement following HBOT (P = 0.03), but the parents found no such difference (P = 0.28).
CONCLUSIONS:
Children with autism who received 20 sessions of either HBOT or a sham air exposure had significant improvements in overall behaviour but there were no significant differences in improvement between groups. The inconsistent changes on CGI sub-scores between parents and clinicians are difficult to interpret, but no overall clinically significant benefit from HBOT could be shown. Both interventions were safe and well tolerated with minimal side effect from middle ear barotraumas.
http://www.ncbi.nlm.nih.gov/pubmed/22987458