 "US President Donald Trump looks on as US Secretary of Health and Human Services Robert F Kennedy Jr speaks during an event about autism in the Roosevelt Room of the White House. Kennedy has touted leucovorin as the \"answer to autism\". AFP")
Donald Trump isn’t a doctor. Yet, on Monday (September 22), the US president made several announcements pertaining to autism, which have disturbed and perturbed the medical community in the United States.
On Monday, Trump, accompanied by his Health Secretary, RFK JR, announced that pregnant women should limit their use of acetaminophen , usually branded as Tylenol in the US or paracetamol elsewhere, which he claimed heightens the risk of autism when used by pregnant women, an assertion hotly contested by scientists internationally and contradicted by studies.
Despite previous scientific claims and backing that acetaminophen — the primary ingredient in Tylenol — is among the safest painkillers to take during pregnancy, the US president insisted that “taking Tylenol is not good” and to “fight like hell not to take it”.
He said pregnant people should “tough it out,” and that only an “extremely high fever” would justify taking the over-the-counter medicine.
Trump, in his announcements, also proclaimed that a new drug, leucovorin, could be the “answer to autism”, saying it could help children with the disorder whose symptoms vary widely across a spectrum.
But what exactly is this drug? Can it really be the therapy required to address autism?
What did Trump say on paracetamol and autism?
In his remarks on Monday, US President Trump vehemently insisted that pregnant people should avoid Tylenol , making contentious claims that the drug causes autism.
“Taking Tylenol is not good … All pregnant women should talk to their doctors about limiting the use of this medication while pregnant,” said Trump, adding, “Don’t take Tylenol. There’s no downside.”
At one point, the US president even said, “There’s a rumour — and I don’t know if it’s so or not — that Cuba, they don’t have Tylenol because they don’t have the money for Tylenol. And they have virtually no autism.”
The 79-year-old American leader even admitted that his remarks were personal theories, adding, “I’m not a doctor, but I’m giving my opinion.”
What is leucovorin, the drug that Trump administration has pitched for?
During the same press briefing, the Trump administration then announced a treatment for autism. Trump and RFK Jr said the Food and Drug Administration (FDA) will approve the drug leucovorin for autism.
Kennedy even went as far as touting it as an “exciting therapy that may benefit large numbers of children who suffer from autism.”
Leucovorin, also known as folinic acid, is a form of folate, an essential B vitamin, or B9. It is already approved by the FDA for counteracting the toxic effects of certain cancer drugs, like methotrexate, that block the body’s use of folate.
Folate is essential to the human body, as it helps the body make red blood cells and is important for cell growth. It’s especially crucial during early pregnancy to lower the risk of major birth defects in a baby’s brain or spine. Studies suggest that folate levels can affect our health in various ways, and scientists are researching what role folate plays in depression, dementia, heart disease, and autism.
And amid this debate on autism and its causes, some researchers have sought to study leucovorin as a possible treatment for autism.
What does the science say about leucovorin and autism?
Some researchers have found that some individuals with autism have difficulty transporting folate to the brain, and believe leucovorin may help deliver it more effectively.
However, the research is still in its early stages, with Richard Frye, a paediatric neurologist who is studying leucovorin, telling the Washington Post, “We’re still on the 10-yard line. But it’s something that we think might be able to help a lot of children.”
In the study that Dr Frye conducted, some children with autism who received folinic acid have seen big improvements in their receptive language. However, for some, the leucovorin had no effect at all.
Researchers in India also studied folinic acid in a small group of children. One group of 39 kids was administered folinic acid while a second group of 38 kids received a placebo. The November 2024 study found children who received the drug had improved scores on topics like speech and nonverbal communication.
However, other researchers have cast doubts on the efficacy of leucovorin as a possible treatment for autism. Alycia Halladay, chief science officer of the Autism Science Foundation has been quoted as saying, “The studies on leucovorin in autism so far have been very small, not replicated or have found inconsistent findings, and not used the same dose.”
She added that the Autism Science Foundation “does not consider this a treatment for autism”.
Dr Karam Radwan, Director of the UChicago Medicine Neurodevelopmental Clinic, also told PEOPLE that “the benefits of using leucovorin were often modest” adding that the problem with the studies is that “there are not many, and these studies have like 50 patients here, 40 patients there.”
He further cautioned that the drug wasn’t a cure for autism. “You’re not going to see people improving in days when we start using it,” he said, adding that “I use it in my practice when it’s appropriate and then find the right patient.”
Echoing similar doubts, Dr David Mandell, a professor of psychiatry and autism expert at the University of Pennsylvania, told Reuters that leucovorin might well be a possible treatment for some children with autism, “but the evidence we have supporting it… is really, really weak.”
Other autism awareness groups and their members also cast doubts on leucovorin as a cure to autism. Emily Willingham, the scientific editor of the Thinking Person’s Guide to Autism, a resource for people with autism, parents, and autism professionals, in a newsletter outlined why leucovorin is an unlikely treatment for the vast majority with autism.
According to a USAToday report, Willingham said backers of this theory believe leucovorin might be a way to replenish folate deficiency in the brain of people with autism. She said if a “mitochondrial deficiency” is linked to autism, then administering leucovorin might be a way to improve symptoms. Still, past studies showed no more than five per cent of autism cases are linked to mitochondrial deficiency, Willingham said.
She further feared that the promotion of leucovorin for autism would be similar to how some hailed ivermectin as a Covid-19 cure.
But why is there so much attention on autism?
Notably, this discussion on leucovorin and the so-called dangers of using Tylenol comes as autism rates in the US continue to rise. About one in 31 kids was diagnosed with autism spectrum disorder by age 8 in 2022, up from one in 36 in 2020, according to the American health agency. In 2015, it was one in 68 children.
Science suggests that genetic and environmental factors may contribute to the risk of developing autism. Researchers have spent decades trying to pinpoint those exact factors.
However, experts note that blaming Tylenol can not end autism. “Regarding autism, we know it is complex, highly variable and increasingly linked to genetics,” Dr Susan Kressly, president of the American Academy of Paediatrics, said in a statement. “There is no single, root cause of autism, and there is no single medication that will give every autistic child or adult what they need. Individualised plans, often involving a combination of developmental, behavioural, educational and social-relational strategies, can help improve outcomes that are meaningful to individuals and families. We also need and welcome additional investments in federally funded research to better support families of autistic children.”
With inputs from agencies