FDA Commissioner Flagrantly Misquoted Harvard Public Health Dean at White House Autism Event

The White House claimed that Dr. Andrea Baccarelli has found a "causal relationship between prenatal acetaminophen use and neurodevelopmental disorders of ADHD and autism spectrum disorder." Not true.

The commissioner of the Food and Drug Administration, Martin Makary, flagrantly misrepresented and misquoted the position of Harvard’s dean of public health on Monday during a press conference in which the administration attempted to make the case that acetaminophen use during pregnancy is linked to autism.

Makary capped off his case against Tylenol by claiming to be quoting Harvard’s Dr. Andrea Baccarelli. “To quote the dean of the Harvard School of Public Health, ‘There is a causal relationship between prenatal acetaminophen use and neurodevelopmental disorders of ADHD and autism spectrum disorder. We cannot wait any longer,’” said Makary, reading from notes.

That would indeed be quite a firm endorsement from the pinnacle of the scientific establishment, given that a “causal relationship” is much harder to demonstrate than an “association.”

It would be big if it was true.

Drop Site was unable to find any record of Baccarelli ever saying anything so definitive, and the assertion is contrary to his publicly stated views. Reached for comment, a Harvard spokesperson responded by providing Drop Site with the statement Baccarelli had provided to the administration.

“We can’t speak on behalf of any of the participants in the press conference,” said Maya Brownstein, media relations manager for the Harvard T.H. Chan School of Public Health. “Dr. Baccarelli provided the attached statement to the White House team organizing the event in advance. The statement explains his research and his recommendations regarding acetaminophen use in pregnancy.” The full statement is posted below, but does not include the quote that made it into the press conference. Instead, Baccarelli said that evidence from animal studies “lends support to the possibility of a causal relationship,” and urges further research. Such a characterization is several layers removed from the certainty asserted by Makary at the White House.

“As we noted in our review,” Baccarelli’s statement reads, “animal studies have independently suggested that prenatal exposure to acetaminophen can adversely affect the developing brain. This biological evidence lends support to the possibility of a causal relationship between prenatal acetaminophen exposure and neurodevelopmental disorders, including autism. Further research is needed to confirm the association and determine causality, but based on existing evidence, I believe that caution about acetaminophen use during pregnancy—especially heavy or prolonged use—is warranted.”

Notably, Makary’s quote of Baccarelli does not appear in the White House fact sheet, which instead quotes him saying, “We found evidence of an association between exposure to acetaminophen during pregnancy and increased incidence of neurodevelopmental disorders in children.” The FDA did not immediately respond to a request for clarification.

Below is the statement Baccarelli provided to the White House, as provided to Drop Site News:

Statement from Andrea Baccarelli, MD, PhD

Dean of the Faculty

Professor of Environmental Health

Harvard T.H. Chan School of Public Health

Colleagues and I recently conducted a rigorous review, funded by a grant from the National Institutes of Health (NIH), of the potential risks of acetaminophen use during pregnancy. We reviewed 46 previously published human studies worldwide.

We found evidence of an association between exposure to acetaminophen during pregnancy and increased incidence of neurodevelopmental disorders in children. This association is strongest when acetaminophen is taken for four weeks or longer.

As we noted in our review, animal studies have independently suggested that prenatal exposure to acetaminophen can adversely affect the developing brain. This biological evidence lends support to the possibility of a causal relationship between prenatal acetaminophen exposure and neurodevelopmental disorders, including autism. Further research is needed to confirm the association and determine causality, but based on existing evidence, I believe that caution about acetaminophen use during pregnancy—especially heavy or prolonged use—is warranted.

At the same time, as the only approved medication for pain and fever reduction during pregnancy, acetaminophen remains an important tool for pregnant patients and their physicians. High fever can pose risks to both the mother and the fetus, including neural tube defects and preterm birth.

After assessing the evidence, my colleagues and I recommended a balanced approach based on the precautionary principle: Patients who need fever or pain reduction during pregnancy should take the lowest effective dose of acetaminophen, for the shortest possible duration, after consultation with their physician about their individual risk-benefit calculation.

I discussed our scientific findings and this recommendation from our review article with Health and Human Services Secretary Robert F. Kennedy Jr. and NIH Director Jay Bhattacharya in recent weeks and appreciate their interest in this study.