“Don’t take Tylenol,” Mr. Trump said standing next to Health and Human Services Secretary Robert F. Kennedy Jr. “Fight like hell not to take it.” If a drug company made the unproven claims aired at the White House, the Food and Drug Administration would threaten legal action.
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Start with what we know about the causes of autism, which is being diagnosed far more frequently. Gene mutations play a role, and some 800 genes have been linked to the disorder. Many parents conceive children at older ages, which can increase mutation risk. The prenatal environment and in utero exposures may contribute, but the truth is the causal evidence is weak and ambiguous.
Broader diagnostic criteria and heightened public awareness have also led to more children with less severe symptoms being diagnosed. Rising autism rates are worrisome and deserve more study.
The same goes for the connection between acetaminophen and autism. Some studies have found that neuro-developmental diseases including autism are more common in children of women who use acetaminophen more often during pregnancy. But correlation doesn’t prove causation, and even the evidence of the association is mixed.
All of this suggests a need for policy caution, which is why the FDA has for many years declined to change the warning label on Tylenol. One reason is because doctors typically advise that pregnant women take acetaminophen as the safest remedy for fever and pain; anti-inflammatory drugs like ibuprofen can endanger a fetus. Fevers and illnesses during pregnancy increase the risk of congenital defects. They’ve also been associated with autism.
The FDA acknowledged as much Monday: “There can be risks for untreated fever in pregnancy, both for the mother and fetus” and “there are contrary studies showing no association” between autism and acetaminophen.
So why the sudden alarm, complete with a presidential presser? The Occam’s razor answer is the influence of RFK Jr., who is carrying water for his friends in the plaintiffs bar. A who’s-who of lawsuit shops are pushing the Tylenol-autism link in federal court. The litigants include the Lanier Law Firm, Beasley Allen, Cooper Law Partners, and Keller Postman. Most have been allies of Mr. Kennedy in other mass torts, such as against the weed-killer Roundup and Merck’s HPV vaccine.
Their main lawsuit claim is that Tylenol’s marketer, Kenvue Inc., failed to warn users about an autism-acetaminophen link. But a judge overseeing the litigation rejected their claims two years ago, and in damning fashion.
The lawyers are hoping the government will breathe new life into them—conveniently timed for their appeal at the Second Circuit Court of Appeals this fall. Lead attorney Ashley Keller told Reuters last week that he planned to alert the appellate court “if HHS follows through and does the right thing.”
And what do you know, HHS will now promote a “nationwide public service campaign to inform families” about the alleged link. The transparent goal is to drum up more claims to drive a bigger damage award or settlement.
The FDA said it will also initiate “a safety label change for acetaminophen” in response “to prior clinical and laboratory studies that suggest a potential association between acetaminophen use during pregnancy and adverse neurodevelopmental outcomes” despite a “lack of clear causal evidence.” (Our italics.)
The lawsuits cite small studies that suffer from a variety of methodological problems and don’t control for confounding variables like maternal illness and genetics, as federal Judge Denise Cote explained in a 148-page ruling in 2023. She eviscerated the analysis of these studies by the plaintiffs’ experts.
“Their analyses have not served to enlighten but to obfuscate the weakness of the evidence on which they purport to rely and the contradictions in the research,” she wrote. Their approach “permitted cherry-picking, allowed a results-driven analysis, and obscured the complexities, inconsistencies, and weaknesses in the underlying data.”
The best studies have tried to control for maternal genetic risk and fevers during pregnancy by examining a woman’s acetaminophen use and autism among different children. Those studies found no link, but the plaintiffs’ experts ignored them. Their “testimony does not reflect a reliable application of scientific methods,” Judge Cote wrote.
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Perhaps no one told Mr. Trump about this trial lawyer campaign, but the costs of his intervention aren’t benign. He’s raising public fear about a useful medicine in a way that could harm maternal and fetal health. Whatever happened to do no harm?
