Director of the Center for Mental Health Policy and Services Research and Perelman School of Medicine Kenneth E. Appel Professor of Psychiatry David Mandell criticized the Trump administration’s Monday announcement linking autism to the use of acetaminophen during pregnancy.
Mandell, who has researched autism for 27 years, said that most studies do not show a link between the use of acetaminophen — the active ingredient in Tylenol — and autism. He criticized the administration’s Sept. 22 recommendation of the drug leucovorin as a treatment for the disorder, calling it “reckless” and lacking sufficient evidence.
His comments come after 1968 Wharton graduate and President Donald Trump announced on Monday that the Food and Drug Administration will begin instructing physicians that the use of acetaminophen during pregnancy can trigger a "very increased risk of autism."
“To the extent that this report says that acetaminophen causes autism, then we are seeing a review of science, not new science, and the review has cherry-picked findings that are not in line with most of the research they’re reviewing,” Mandell wrote in a statement to The Daily Pennsylvanian.
According to Mandell, studies on acetaminophen use during pregnancy are difficult to execute “because you have to separate out the effects of taking acetaminophen from the reasons women take it.”
“For example, women who have children with neurodevelopmental delays, like autism, report more headaches and pain during pregnancy than other mothers. We know that fevers in pregnancy also increase risk for having a child with a neurodevelopmental delay,” he continued. “The studies that take these things into account, including the two most recent studies, find that taking acetaminophen doesn’t increase risk for autism.”
Mandell also noted that use of acetaminophen has “remained flat” in pregnant women in recent decades, and that most pregnant women take it while only “very few” give birth to children with autism.
“There’s mathematically no way it could be responsible for the rise in diagnostic rates,” he wrote.
In response to a request for comment, the Department of Health and Human Services referred the DP to press releases on their website.
“Given the conflicting literature and lack of clear causal evidence, HHS wants to encourage clinicians to exercise their best judgment in use of acetaminophen for fevers and pain in pregnancy by prescribing the lowest effective dose for the shortest duration when treatment is required,” one press release read.
A request for comment was left with the FDA.
The release also addressed HHS Secretary Robert F. Kennedy Jr.’s announcement that leucovorin could be used to treat symptoms of autism in children.
“While promising, it is important to note that leucovorin is not a cure for ASD and may only lead to improvements in speech-related deficits for a subset of children with ASD. Furthermore, this treatment must be administered under close medical supervision and in conjunction with other non-pharmacological approaches,” the HHS release read.
Mandell wrote that the leucovorin announcement was based on five “small” trials, including several that “engage in some questionable statistical practices … to try to find an effect.”
“We favor a large, rigorous, independent trial,” he wrote. “In the absence of that, to tout [leucovorin] as a cure is reckless and will empty families’ bank accounts for no reason.”
On Monday, the Trump administration also announced a series of new funding initiatives to advance autism research, including a joint project between Penn Medicine and the Children’s Hospital of Philadelphia.
The project — led by CHOP Psychiatry professor Judith Miller — will focus on identifying "genetic and environmental factors that lead to an autism diagnosis."
"Today’s actions represent an unprecedented, comprehensive approach to deepen our understanding of the causes of autism … and ensure that every child has a better chance to thrive," Penn graduate and Centers for Medicare and Medicaid Services Administrator Mehmet Oz said in a statement.
"By providing access to a drug to treat symptoms associated with autism, we are providing hope to families and providers who have until today had very limited options," Oz added, who received both an MD from Penn Med and an MBA from Wharton in 1986.
