After several months of the Trump administration's push to identify root causes of the U.S.' "autism epidemic," President Donald Trump said over the weekend that he thinks "we found an answer."
The White House has scheduled a Monday afternoon press conference to deliver “significant medical and scientific findings for America’s children,” the president’s public schedule shows.
According to The Washington Post, the announcement will see health officials propose a link between autism and use of the over-the-counter pain med Tylenol (acetaminophen) during early pregnancy, as well as offer a potential autism treatment in leucovorin, a folic acid med used to reduce the toxicity of certain chemotherapies.
Trump teased the event as “one of the most important news conferences I’ll ever have” at the Sept. 21 memorial service for late conservative political activist Charlie Kirk.
“I think we found an answer to autism,” he said. “We’re gonna be talking in the Oval Office in the White House about autism, how it happens, so we won't let it happen anymore, and how to get at least somewhat better when you have it, so that parents can help their child, their beautiful child.”
Department of Health and Human Services Secretary Robert F. Kennedy Jr. made the nation's “autism epidemic” a central component of his Make America Healthy Again campaign and previously declared September as the deadline to determine the cause of rising autism rates through a “massive testing and research effort.”
About 1 in 36 children have been diagnosed with autism spectrum disorder (ASD) in the U.S., according to the Centers for Disease Control and Prevention, reflecting a much wider prevalence than the 1 in 150 children reported in 2000.
However, advocacy groups such as Autism Speaks have long maintained that autism is the result of a combination of genetic and environmental influences and that greater prevalence of the condition can be chalked up to increased awareness, broader diagnostic criteria and improved screening tools.
Nonetheless, the administration’s reported plans to link autism to Tylenol have been floating around since early September, prompting quick pushback from autism and maternal health experts alike.
“At this time, the weight of scientific evidence that acetaminophen use during pregnancy causes an increased risk for autism or ADHD is simply inconclusive,” the Society for Maternal-Fetal Medicine said in a Sept. 5 statement, adding that untreated fever and pain during pregnancy carries significant health risks. The Autism Science Foundation agreed that any link between the two is based on “limited, conflicting and inconsistent science.”
Tylenol has been marketed since its FDA approval in 1951, first by Johnson & Johnson and now by the company's consumer healthcare spinout Kenvue. Besides the branded Tylenol franchise, off-brand options are widely available and are produced by a range of generics manufacturers.
The FDA’s current position on the drug’s use during pregnancy states that the agency has “not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes.”
“We believe independent, sound science clearly shows that taking acetaminophen does not cause autism,” a Kenvue spokesperson told Fierce Pharma in an emailed statement. “We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers.”
Health officials at the Monday afternoon press conference are expected to warn pregnant woman against taking Tylenol early on unless they have a fever, the Post reported, citing four people with knowledge of the plans. Kenvue shares were down 6% on Monday morning.
Leucovorin
The White House’s autism findings will also position leucovorin as an autism treatment, according to the Post. As it stands, there are no FDA-approved treatments for autism, although J&J’s atypical antipsychotic Risperdal (risperidone) and Otsuka’s Abilify can be used to counter irritability associated with the condition.
Leucovorin has been used since the 1950s to counter the effects of folic acid antagonists such as methotrexate chemotherapy. As current research suggests that folate deficiency may be associated with ASD, the drug has been involved in early autism treatment studies, where it has shown potential in decreasing autism severity and improving language and speech. However, the Autism Science Foundation noted earlier this month that the "science is still in very early stages, and more studies are necessary before a definitive conclusion can be reached."
Still, physicians involved in talks with the administration told the Post that RFK Jr. may be looking to fast-track an FDA approval for leucovorin as an autism treatment.
In conjunction with these developments, the Federal Register recently showed that the FDA plans to approve leucovorin calcium tablets. The drug was previously marketed as Wellcovorin, according to the filing. The Federal Register document has since been withdrawn at the request of the FDA.
The Wall Street Journal reported on the Federal Register filing—and its withdrawal—Monday.
Meanwhile, the administration is working on a broader autism initiative that will look at 30 hypotheses about potential causes, Politico reported Monday morning.