Five months after the Trump administration announced with great fanfare that it was authorizing an unproven treatment for certain forms of autism, the U.S. Food and Drug Administration (FDA) reversed course on Tuesday.
The use of folinic acid (leucovorin in English) remains unauthorized for certain forms of autism, a complex neurodevelopmental disorder with a broad spectrum, contrary to a previous announcement by the Trump administration.
However, this treatment, previously authorized to prevent certain side effects of chemotherapy, will now be able to benefit people suffering from a rare genetic syndrome known as cerebral folate deficiency.
"This gives hope to many parents of autistic children about the possibility of improving their lives," President Donald Trump said in September during a White House press conference in which he trampled on the scientific consensus and made numerous controversial statements about autism.
The American medical and scientific community had strongly condemned his questioning of paracetamol and vaccines, and had criticized this announced authorization as far too premature.
Although a few studies conducted on a very small number of patients have suggested that taking folinic acid may help reduce some communication or interaction difficulties related to autism, this avenue still requires much research.
Its authorization at this stage therefore risked "raising false hopes," dozens of autism specialists warned in a joint letter.
Despite Donald Trump's desire to see this treatment approved, the US Food and Drug Administration backtracked due to a lack of "sufficient data," an FDA official admitted to NBC News.
However, some autistic people may take folinic acid if they suffer from a cerebral folate deficiency or if their doctor prescribes this treatment outside of the approved indications.
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