The autism researcher cited by Trump officials had been thrown into testimony

A dean of Harvard and a pre -eminent epidemiologist whose work was quoted by senior health officials in the Trump administration as justification to seriously reduce the use of tylenol by pregnant women due to an supposed link with autism provided a testimony of experts in a lawsuit against the manufacturer of drugs that a federal judge called “unreliable”.

Andrea Baccarelli, dean of the Harvard Th Chan School of Public Health, submitted a written testimony in 2023 that his review of scientific literature led him to conclude that prenatal acetaminophen exposure, the active ingredient in Tylenol, “can cause the development of offspring”. A Harvard spokesman said Baccarelli had been paid about $ 150,000 for his work on the case.

The judge of the Federal Court has excrupted the testimony of Baccarelli, by writing that “Dr. Baccarelli minimizes studies which undermine his causal thesis and emphasizes those who line up on his thesis”.

The American district judge Denise Cote du District Sud de New York noted that neither Baccarelli nor four other experts paid to testify for the complainants “has published research that express the ultimate opinions they offer here. practical.”

Cote ruled that the testimony of the five expert witnesses should be excluded from the case.

We don’t know what Baccarelli believes. On Monday, before the Trump administration’s announcement that this would recommend to a high -scale use of acetaminophen during pregnancy, Baccarelli published a statement saying: “Additional research is necessary to confirm the association and determine causality, but on the basis of existing evidence, I think that prudence concerning acetaminopens during pregnancy – in particular existing evidence – is guaranteed.”

Harvard spokesperson Stephanie Simon refused to make Baccarelli available for an interview and would not answer questions about his testimony of experts or the judge’s decision to exclude him. She said Baccarelli, who became dean in 2024, sent the declaration to the best federal health officials, who asked her to summarize her work at the press conference on Monday. Baccarelli had already spoken by phone with the health secretary Robert F. Kennedy Jr., and the director of the National Institutes of Health, Jay Bhattacharya, to discuss his recent work.

The Commissioner of Food and Drug Administration, Marty Makary, cited an article published by Baccarelli and his colleagues last month at the Monday press conference, saying: “A study by MT. Sinai-Harvard examined all existing literature and found the body overwhelming evidence in an association.” He then added, apparently in reference to the testimony of Baccarelli experts, “to quote the dean of the Harvard School of Public Health”, there is a causal relationship between the prenatal use of acetaminophen and the neurodevelopmental disorders of ADHD and the autism spectrum disorder. ” ”.

The most recent article in Baccarelli, a review of 46 human studies published above, found an association – and not a causal relationship – between the use of acetaminophen during pregnancy and neurodevelopmental disorders. He concludes that “appropriate and immediate measures should be taken to advise pregnant women to limit the consumption of acetaminophen to protect the neurodevelopment of their offspring.”

Other researchers and epidemiologists of autism have questioned the claim of this article, claiming that the methodology of the authors does not give them the ability to assert that the Trump administration must snap the brakes on the reduction of the use of Tylenol. Psychiatrist David Mandell appreciated that Baccarelli revealed his paid testimony in the publication, but that makes him question the results.

“When I combine that [disclosure] With what I consider to be significant decisions concerning the analysis which biaries them towards a particular result, it makes me uncomfortable to count on this review to say anything about the question of the Acetaminophen of Autism, “said Mandell, director of the mental health center of the University of Pennsylvania.

The authors analyzed six studies to specifically seek an association between the use of acetaminophen during pregnancy and autism, although they included two analyzes of a single article in the form of two studies. This article, a JAMA study in 2024, made waves when it was published because it used a massive database of 2.5 million children born in Sweden from 1995 to 2019.

What was impressive in this study is that the researchers controlled genetics by looking at mothers who had taken Tylenol during a pregnancy but not the other. Once they have been adjusted for the contribution of genetics, the association between acetaminophen and autism has practically disappeared. Baccarelli and the other authors of the journal included both the unresolved and adjusted results – a decision that strengthened the association with autism but researchers perplexed not affiliated with the study.

The other authors did not immediately respond to a request for comments.

“I have never seen any review of any kind or meta-analysis, at any time, in which someone said, I don’t like the adjusted results, so I will include the unresolved results,” said Mandell.

Other researchers considered that the evaluation by the authors of the quality of proof of each article was subjective compared to other syntheses and review of the literature.

“If they could be blinded to the results of the study and assess the quality, I think it was more convincing. I think they are only their opinions,” said Maureen Durkin, professor of health sciences at the University of Wisconsin-Madison.

Earlier this month, another study, using data from 217,602 children in Japan, found no effect between the use of acetaminophen and autism. Although there is a scientific debate on the question of whether the acetaminophen used during pregnancy is associated with autism rates, if that affects them at all, researchers say that the evidence is strong that pregnant people should take Tylenol if they need it to fight pain or fever – which can also affect the neurodevelopment of the fetus if they are not treated.

“Intelligent people can disagree on the force of evidence,” said Mandell. “Where it is really difficult, it is when you have government representatives on the one hand in a way that can considerably affect the health of a large part of our population.”

Correction: This story has been updated to say that Baccarelli discussed his research with Kennedy and Bhattacharya by phone.

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