Treatment of autism spectrum disorders via dietary modifications is a still somewhat controversial intervention, but one that is clearly supported by the medical literature, said Dr William Shell, the company’s CEO and chief medical officer.
“If you review the Pubmed literature of the amino acid concentrations in the blood of children or adults with autism spectrum disease and you concentrate on the mass spectroscopy measurements that have been evolved over the last three to five years you find that there is almost uniformly in reports out of universities observations of the alteration of amino acids concentrations in those people,” Shell told NutraIngredients-USA.
“It’s pretty consistent and it involves the glutatmate/glutamine ratio as well other neurotransmitter precursor deficiencies,” he said.
“There is also evidence of malabsorption of certain amino acids,” added Dr David Sliver, COO of Targeted Medical Pharma.
Preliminary data
The company has gathered preliminary data relating to the performance of an amino-acid based capsulated medical food in the reduction of explosive behavior among children with autism spectrum disease (ASD) symptoms. Twenty six children ages seven to sixteen were treated for a time period ranging between 30 days and 1 year, who were diagnosed with ASD or suffering from related symptoms including explosive behavior, social isolation, and mood disorder. The company said that its investigator found that children demonstrated significant improvement with regards to decreased disruptive outbursts, improved socialization, improved mood and reduction in drug dose.
All of the patients responded positively with an average improvement in explosive outbursts of 83% compared to baseline, with patients also demonstrating significant improvements in anxiety and mood regulation.
Inborn error of metabolism
Shell believes that the demonstrated changes in amino acid concentrations for ASD affected patients means that the disorder falls into the realm of the “inborn errors of metabolism” mentioned in FDA’s recently updated draft guidance on medical foods. The question of how these observed deficiencies relate to the underlying disorder is more difficult to answer, he said.
“That’s a difficult question to answer because the cause of autism isn’t understood. Therefore I can’t assert that there is a causal relationship, that is, do the amino acid deficiencies cause the autism or is it the other way around. There is no way at this point to make the link,” he said.
“However, there appears to be some genetic component to autistic spectrum disease so therefore this is an inborn error of metabolism of some sort. It is our position that whatever the error is, it is enhanced by the nature of the American diet,” Shell said.
Target Medical Pharma’s medical foods (the company also manufactures dietary supplements) are meant to be used with the supervision of a physician, who among other things could help determine the dosage for younger patients who might vary widely in weight, Shell said. Shell said his company is a strong supporter of the guidelines laid out in the updated draft guidance.
“We think the FDA did a very good job in clarifying the situation and that’s why we have not commented (on the guidance),” Shell said.