Will FDA Turn Natural Autism Treatment Into Drug?

A promising treatment has shown remarkable success in treating autism—but will the FDA turn it into a Big Pharma blockbuster? Action Alert! Recently we reported on the advancements in research regarding fecal microbiota transplants (FMT), which harness the power of the gut microbiome to treat illness. A recent study has found that FMT reduced autism symptoms by 50%. This is a stunning finding that provides further evidence of the incredible potential of FMT, but the FDA is on the verge of turning this affordable treatment into an expensive drug and thus potentially putting the treatment out of reach for many patients. Part of what makes these findings so remarkable is the lasting effect of FMT. The improvement in gut health and autism symptoms persisted long after FMT was administered—up to two years later in the study. Similar effectiveness was found when FMT was used to treat an antibiotic-resistant bacterial infection that kills 30,000 Americans a year—most patients required just a single dose of FMT to fully recover. It is a testament to the power of the gut microbiome. There is sound logic behind using FMT to treat autistic patients. Many autistic children have gastrointestinal (GI) problems. These children tend to have the worst autism-related symptoms: chronic GI discomfort can cause irritability and negatively impact behavior. Relieving GI discomfort through FMT can thus go a long way in improving autism symptoms. Autism is one of the potential applications of FMT, but there are many more. It is being studied for a wide variety of indications, including ulcerative colitis, Crohn’s Disease, Parkinson’s disease, multiple sclerosis, childhood regressive autism, metabolic disorders, diabetes, and others. FMT could lead to the next generation of medicines that utilize the trillions of microbes living within us to heal. Currently, the pioneers behind FMT have a non-profit stool bank, OpenBiome that supplies most of the fecal matter for transplants in the US. Why, after all, should human feces carry an exorbitant price tag? Yet apparently that is exactly what the FDA thinks should happen. As we reported previously, the agency is on the verge of deciding the future of FMT. The agency is deciding whether to regulate FMT like a new drug, or more along the model of donated organs, tissues, and blood products that are transferred from a healthy donor to a sick one. (Read our previous coverage for a more detailed discussion of the distinction between these two models.) The drug model would of course allow Big Pharma to create monopoly drugs and charge a fortune for them, so we believe that is exactly what the FDA will do. It is what the agency has already done to a number of natural supplements such as CBD oil, L-glutamine, and the pyridoxamine form of vitamin B6. It’s unfortunate that the FDA seems more committed to guaranteeing Big Pharma profits than looking out for public health. The decisions the agency is making are driving up the costs of healthcare for Americans. The benefits of FMT should be available to everyone, not just those who can afford to pay Big Pharma’s monopoly prices. Action Alert! Write to Congress and the FDA, urging the agency NOT to regulate FMT like a drug. Please send your message immediately.