“For too long, families have been left without answers or options as autism rates have soared,” said Health and Human Services Secretary Robert F. Kennedy Jr. Monday. “Today, we are taking bold action – opening the door to the first FDA-recognized treatment pathway, informing doctors and families about potential risks, and investing in groundbreaking research.”
Kennedy and President Donald Trump rolled out the new program during a Monday press conference. However, many experts have questioned the plans, which include promoting the drug leucovorin while also discouraging the use of Tylenol, a brand name for the common over-the counter pain reliever acetaminophen.
“Taking Tylenol is not good,” said the president, who then told pregnant women not to take the medication. Trump also noted the increase in autism diagnoses over the past 25 years, saying: “The meteoric rise in autism is among the most alarming public health developments in history.”
Autism is a term that covers a broad range of developmental disabilities caused by differences in individuals’ brains. Data from the U.S. Centers for Disease Control and Prevention does show that the prevalence of autism diagnoses increased from one in 150 in 2000 to one in 31 in 2022. According to Christine Ladd-Acosta, vice director of the Wendy Klag Center for Autism and Developmental Disabilities at Johns Hopkins Bloomberg School of Public Health, this increase can be mostly attributed to a broadening of the Autism Spectrum Disorder definition and increased screening.
Multiple experts weighed in on the Trump administration’s autism announcement with Audacy stations Tuesday. Here’s what they said.
“We have been working really hard for many decades identifying what the real causes of autism are, and that news conference really set us back,” said Dr. Amy Esler from the University of Minnesota.
Regarding Tylenol or acetaminophen – a bit of a tongue twister that Trump struggled to pronounce – Esler said that there have been a few studies that link the use of the pain reliever during pregnancy to autism. However, there are issues with that research.
“The problems with those studies is that they did not take into account the reasons that a mother might be taking Tylenol, and those reasons could really be what’s associated with autism rather than the Tylenol,” she explained. “So, things like infections that we know have been associated with autism, pain from autoimmune disease… so the studies didn’t really control for these factors.”
Esler said that a large study in Sweden that controlled for those factors as well as genetic factors found no relationship between acetaminophen and autism.
“President Trump’s claim that Tylenol is leading to autism cases is not founded,” Dr. Megan Maher, assistant professor of clinical psychiatry at LSU Health New Orleans, also said. “There’s been some very small studies that point to some possible correlation, but when they’ve looked at all the different confounding factors within the study and then looked at it with millions of children, they have not found Tylenol to be a risk factor for autism.”
Maher also noted in an interview with Audacy that prenatal conditions ranging from autoimmune diseases or obesity or gestational diabetes have been linked to autism in children. She said complications at birth can also be a factor. Genetics appears to be an even stronger factor, according to Esler.
“One of the comments yesterday at the news conference was that this work on genetics has not been fruitful,” she said. “Well, the fact of the matter is 60% to 90% of autism cases are accounted for by genetics and there’s nothing moms can do during pregnancy to change the genetics.”
Both Esler and Maher said that pregnant women should consult their doctors about what medications to take. WashU Medicine Autism researcher Dr. Greg Cejas told Audacy station KMOX the same thing and added that more research is needed into the link between acetaminophen and autism.
KMOX reported that Kenvue, the maker of Tylenol, said in a statement provided to CBS News that acetaminophen is the safest pain reliever option for pregnant women.
“Today’s White House event on autism was filled with dangerous claims and misleading information that sends a confusing message to parents and expecting parents and does a disservice to autistic individuals,” said the American Academy of Pediatrics in a statement.
In a press release, the U.S. Food and Drug Administration also noted that: “It is important to note that while an association between acetaminophen and neurological conditions has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature.” Furthermore, it said that “acetaminophen is the only over-the-counter drug approved for use to treat fevers during pregnancy, and high fevers in pregnant women can pose a risk to their children,” and that other aspirin and ibuprofen (other common OTC pain relievers) have been linked to adverse outcomes. Still, the FDA imitated a process for a label change on acetaminophen products Monday.
“The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” said FDA Commissioner Marty Makary. “Even with this body of evidence, the choice still belongs with parents. The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment. It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.”
Along with starting the process to change labels on acetophenone bottles, the FDA also initiated the approval of leucovorin calcium tablets to treat cerebral folate deficiency Monday. This treatment is already FDA approved to treat chemotherapy side effects, according to The New York Times.
It is also used to treat megaloblastic anemia, which commonly occurs when the body doesn’t get enough folic acid, and has been used off-label for around 20 years to treat people diagnosed with cerebral folate deficiency, a neurological condition that affects the vitamin folate from being transported into the brain. Experts cited by the Times said side effects from leucovorin are minimal.
“Individuals with cerebral folate deficiency have been observed to have developmental delays with autistic features (e.g., challenges with social communication, sensory processing, and repetitive behaviors), seizures, and problems with movement and coordination,” said the FDA. It is working with GSK, the maker of Wellcovorin (leucovorin calcium).
Maher and Esler told Audacy that there is no cure for autism. They both said that more research is needed regarding the impact of leucovorin, though Esler noted that types of folic acid are already commonly recommended during pregnancy. Maher said applied behavioral analysis also helps children with autism.
“Women who are pregnant and families considering new therapies for autism should always consult with their doctor,” said Autism Speaks in a statement. It also said: “We urge the Administration’s resources be dedicated toward advancing new and innovative areas of research, so the community benefits from fresh insights, rather than revisiting questions that have been well studied, including vaccines and autism.”