Sunday Smiles

David Strom 2:00 PM | September 28, 2025
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First things first: there is no PROVEN link between the use of acetaminophen during pregnancy and the development of autism in children. 

That's a pretty weak statement, though, and the rather thin read that Jansenn and then Kenvue, the makers of Tylenol, rely upon to make their assertion that Tylenol use does not contribute to the development of autism. 

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Scientifically proven links in medicine are relatively rare--in fact, there is relatively little evidence that a lot of drugs do what they claim to do, with the difference in outcomes between placebos and beneficial outcomes being modest to nonexistent. Some of the most commonly prescribed drugs, such a SSRIs, are FDA approved despite links with serious or even fatal side effects and relatively small benefits that are barely distinguishable from a placebo. There are plenty of dangerous surgical procedures, such as many back surgeries, that are often performed and are usually unsuccessful. 

Some drugs and medical procedures are nearly miraculous, while others turn out to be busts when they hit the market, despite being FDA-approved. 

We can argue whether the preponderance of the evidence shows a link between autism and Tylenol use during pregnancy, but not whether there is a lot of evidence that there is one. Even Johnson & Johnson, in internal documents obtained in discovery for an upcoming lawsuit, was very concerned about the potential link. Johnson & Johnson spun off its Tylenol business in 2023. 

The pharmaceutical company behind Tylenol privately acknowledged the likelihood of an association between its drug in pregnancy and neurodevelopmental disorders like autism in children seven years ago, company documents obtained by the Daily Caller News Foundation show.

“The weight of the evidence is starting to feel heavy to me,” said Rachel Weinstein, U.S. director of epidemiology for Janssen, the pharmaceutical arm of Johnson & Johnson, in 2018. Johnson & Johnson marketed Tylenol at the time but in 2023 spun off its consumer products division into a separate company called Kenvue.

Legacy media headlines and vocal public health experts have dismissed the conclusion of President Donald Trump and Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. that Tylenol taken in pregnancy and early infancy has driven rises in autism. But one stakeholder has for years viewed the evidence as credible enough to act upon, at least privately: The makers of Tylenol.

Johnson & Johnson researchers considered doing their own study after multiple independent researchers found a link, and decided not to pursue it for obvious reasons. 

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“Not much choice but to consider this a safety signal that needs to be evaluated,” J&J Office of Consumer Medical Safety Lead Andre Mann wrote in 2008 after receiving a letter from a physician with concerns.

Leslie Shur, the head of the division of Johnson & Johnson that monitors the side effects of drugs already on the market, received an alert in 2012 about concerns about acetaminophen and autism from a concerned father, with one employee writing “in case this goes to press.”

Concerns about a link between Tylenol and neurological disorders may have reached the C-suite by 2014, according to another email, which references then-Johnson & Johnson CEO Alex Gorski.

The makers of Tylenol have closely tracked a drumbeat of scientific publications finding an association between taking the blockbuster drug in pregnancy and infancy and autism risk, other company documents show. 

A 2018 internal presentation the company labeled “privileged and confidential” acknowledges that observational studies show a “somewhat consistent” association between prenatal exposure to Tylenol and neurodevelopmental disorders. Another presentation slide acknowledges that larger meta-analyses — reviews summarizing multiple scientific studies — found an association, but notes weaknesses of these studies like confounding variables and subjectivity in measuring autistic traits.

“Johnson & Johnson divested its consumer health business years ago, and all rights and liabilities associated with the sale of its over-the-counter products, including Tylenol (acetaminophen), are owned by Kenvue,” a Johnson & Johnson spokesman said in a statement.

Observational studies are always weak compared to double-blinded placebo-controlled studies, yet decisions about taking drugs off the market or adding warnings are often made using such studies once a drug sees wide distribution. Smaller studies may not detect safety signals because rarer side effects or longer-term dangers are often missed in drug trials. 

Emails show employees of Johnson & Johnson discussing a 2018 literature review concluding that pregnant women should be cautioned against indiscriminate use of Tylenol as well as a 2016 study that concluded that prenatal exposure to acetaminophen was associated with autism “with hyperkinetic features,” or abnormal involuntary movement, though not with autism without those symptoms.

Weinstein, the company epidemiologist, wrote to one of the authors lauding the “substantial strengths of the study design,” the “strength and robustness of the association,” and the study’s ability “to control for possible confounding by indication,” that “lend support to the findings.” Weinstein joined Kenvue from Johnson & Johnson but has since retired, her LinkedIn shows. She could not be reached for comment.

In 2018, Weinstein and other top scientists within the company considered funding follow-on studies about the drug’s autism risk but eventually opted against “sticking their necks out.” Weinstein mentioned that they could end up confirming the findings. The company noted in a 2018 presentation that recommending against Tylenol in pregnancy would leave women with few options.

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Few of us doubt that longer-term studies showing a link between the mRNA vaccine and dangerous outcomes are coming--many are already here--and safety signals only show up once a drug is out in the wild. The link between myocarditis was identified in VAERS, and after further studies, it was acknowledged. Look up lists of drugs withdrawn from the market, and you will find it is long, and in most cases, the manufacturers were not happy about having to do so. 

Given what we DO know, it is hardly improper for public health professionals to inform people about potential risks, even if the evidence is less than perfect. Smart and unbiased people on both sides of the Tylenol safety debate can conclude that the weight of the evidence supports their conclusion, which, to any sane person, should suggest that pregnant women be informed of the potential risks. Smart people may conclude that either choice made by a patient was wrong, but it is not the role of physicians or public health officials to withhold data they find inconvenient.

Let me share a personal experience regarding my heart surgery from 21 years ago. I tend to have a bad memory, but some things stick because they were significant enough to be imprinted, and this was one such. 

When discussing the risks and benefits of the surgery, I asked about the worst possible outcomes and the likelihood attached to each. The surgeon reassured me that I was a great candidate with infinitesimal risks--only about one chance of death in 100, and a 5% chance of stroke. 

As a surgeon, he thought those were outstanding odds; as a patient who knew more than 100 people, I thought they sucked. If 100 people I knew went in, one would not come out, and five might have permanent mental disabilities. One out of 20. 

I got the surgery anyway, but clearly our sense of risk diverged significantly. He saw people die pretty regularly; I have only one life. 

We know that some women would, if they knew that Tylenol posed a risk to their fetus, choose to forego its use. After all, there are women who refuse abortions even if they face cancer or a large chance of their own demise, and we respect their decisions and should. 

The same goes for using Tylenol. 

I am frankly appalled that there are medical professionals who are angry that women are being told of a potential risk to their fetuses, not because I think they are indifferent to their health, but because they want to substitute their risk tolerance for that of the patient. It is an arrogation of power that belongs elsewhere. 

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I will admit that I believe that Trump should let the professionals make medical recommendations--he has tweeted out that pregnant women should not take Tylenol, which is not HIS role either. I am not defending Trump or MAGA in this instance. Although I would note that at least he is not trying to withhold potentially vital information from patients, which is worse. 

Nobody is banning Tylenol or its use during pregnancy, and the people losing their minds over this are acting as if they were, and based on misinformation. The information is ambiguous, but real and significant. Doctors can still recommend Tylenol, and it remains on the market. Demanding that government officials remain quiet and slandering researchers for reporting true information is, unfortunately, very on brand these days. 

Every time a doctor, regulator, or researcher insists that people should be silenced, they erode their credibility. Soon enough, vast numbers of people will ignore them and their advice, and we have already seen TikTok trends of anti-MAGA people quaffing Tylenol (which IS dangerous in large doses) to prove their commitment to The Science™. 

Scientists are way too political and demand unearned authority. Stop it. 


















































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