This post needs reading in conjunction with – ideally just before – reading Partnerships in Healthcare on dh.org.
Over several decades, most people I know, have, along with me, seen Gary Schwitzer, who runs a Health News Review Substack, as the best reviewer of lay and academic media accounts of health issues. Among Gary’s great skills is an ability to pinpoint how media coverage misses the key points of published research typically over-selling the promise of some breakthrough and neglecting to mention the consequences.
FDA Take One
The media frenzy that followed the FDA panel on SSRIs in pregnancy was always likely to draw Gary’s attention and has.
FDA’s Makary stacks the deck with conflicted expert panels.
His coverage of this was however very different to the material he usually deals with – at least the material I’m aware of. His take on the lay and professional reporting linked to the Panel laid out some of the key themes these accounts share, avoiding, as he says, any comment on content.
The Stacks the Deck post seems similar to me to what I attempted in the comments section following the FDA Panel Unsafe Safety Post, where over 30 lay media takes on the Panel, close to uniformly panning both Panel and Panelists, are hosted – without comment.
There is little need for comment – there is a uniform sameness about the coverage, which gives the impression that several of then are likely to be driven by or written by A.I.
I have not attempted to pull out themes, partly because the media coverage is almost entirely American and I risk misreading what is being said. Gary’s reading of the themes has to be more dependable than mine – but at the moment unless the message is in between the lines, which is quite possible, he seems to me to have missed some points.
I have directed comments from some Europeans, other FDA Panelists, and others and linked them to two dh.org posts, which ran in parallel with the RxISK Unsafe Safety post – FDA Panel SSRIs and Pregnancy and There’s Something About Pregnant Mary. These comments bring out themes that strike non-Americans.
I have also separated the lay media commentary from professional organization inputs. The professional inputs are linked in the comments section after Adam Urato and SSRIs in Pregnancy. The professionals offer to advise FDA and Marty Makary on what FDA and he should be doing and thinking.
Gary’s Substack is illustrated with the logos of some of these professional healthcare organizations like the American College of Obstetricians and Gynecologists (ACOG), the Society of Maternal and Fetal Medicines (SMFM) and others. It is beautifully laid out piece with other great images and is well worth reading.
FDA Take Two
Since the FDA Panel and Gary’s Substack post, we have had a replay of the SSRI and pregnancy media coverage featuring Tylenol and Pregnancy. The same lay media and professional bodies are weighing in with similar themes.
I have attached as comments to this post the links to 6 of these that have come my way along with the full text where I have been able to access the articles.
Partnerships
Gary’s Stacking the Deck post has a dh.org linked – Partnerships in Healthcare. The Partnerships post is essentially written by Pharma rather than me.
My hope was to have Partnerships stand as a complement to all of the above without me having to say anything – other than clarify some details for folk to whom material like this is new.
Partnerships shows the professional and other organizations – the list of Partners – that all pharmaceutical companies reach out to, whether we are talking about autism and SSRIs or autism and Tylenol, or Alzheimer’s Dementia and the latest treatments, or Osteopenia and its treatments.
The lay media are not listed in Partnerships but, on issues like pregnancy, Alzheimer’s and osteoporosis, the New York Times, Washington Post, Wall Street Journal and all sorts of other media can be depended to access groups like ACOG and SMFM or their equivalents in other areas of medicine, along with Women’s Health, Autism Support and other groups in the relevant space.
The seventh and eighth images in Partnerships are key. For some readers, these may be jaw dropping but they should come as no surprise. The only jaw dropping element is seeing something everybody suspects is, but would prefer not to be, going on laid out so brazenly and graphically.
The surprise perhaps is that NYT, The Washington Post and others must know on one level that this is exactly what is going on, but are acting as though nothing like this could possibly be in the background to their reporting.
The lay media reporting as it stands could well have been written by A.I. Surely at some point, NYT, the Washington Post and others (increasingly referred to as legacy media) must realise they will be out of business unless they can grapple with and report on some of the consequences of treatments and not just their promise. Unless the legacies build on feed other than company feed delivered through their Partners or A.I., they look like they are toast – except for their usefulness to companies
FDA Take Three
It should come as no surprise that FDA do not have an outreach operation like the ones companies put a lot of time and money into creating and fostering. An outreach that some might hope could combat what the lay media are fed by company Partners.
It may be more of a surprise, may even sound incredible, that companies might welcome FDA or HHS setting up Panels to review the evidence for SSRI or Tylenol use in pregnancy or linkage to autism.
As things stand, FDA risk providing a talking point that companies can use to their advantage by mobilising their patient groups, professional bodies, politicians and others to splutter indignantly in defence of the rights of women and babes in utero (or patients with dementia, osteoporosis or other conditions affecting women mostly) against – pick your words to describe HHS/FDA.
FDA panels risk de facto working to a company agenda for companies who know that in the midst of all the media noise, mostly defending readers’ rights against FDA, the only things over 90 per cent of readers will retain is the name of the company product and the reader’s constitutional right to access this product or born with a warranty right to use it.
It also works because no matter how much FDA might huff or puff it is companies not FDA who are obliged to issue warnings. For companies it is wonderfully helpful to be able to indicate to courts that FDA have reviewed this problem again and again and have not asked us to change anything. FDA and us – thanks to the legacy media – risk being Rope a Dope victims.
This is fertile ground for a few conspiracy theorists. The material can be mobilized as evidence that rather than being played by companies FDA are deliberately playing into company hands.
Heads we win, Tails you lose.
Put that in your pipe and smoke it as the saying goes.
Postscript
Gary and other reviewers appear to have missed an American Psychiatric Association letter to Dr Makary. This will form the basis for two follow up posts developing the perils of letting A.I. or Pharma shape professional messaging.
Dr. David Healy says
Wall Street Journal: What’s News September 5th
In a report this month, Robert F. Kennedy Jr. plans to announce that pregnant women’s Tylenol use and folate deficiencies are potentially linked to autism.
The Department of Health and Human Services report will also suggest a medicine derived from folate can treat autism symptoms, according to people familiar with the matter. Scientists say conducting rigorous autism research can take years; to date, a variety of possible contributors have been identified. The American College of Obstetricians and Gynecologists says Tylenol is safe but recommends pregnant women consult with their doctors, as with all drugs. Tylenol maker Kenvue denied any causal link between the drug and autism.
Dr. David Healy says
CNN September 5
Upcoming HHS report will link autism to common pain reliever, folate deficiency in pregnancy, Wall Street Journal reports
By Brenda Goodman Deidre McPhillips Sep 5, 2025
An upcoming report from the US Department of Health and Human services is likely to link the development of autism in children to a common over-the-counter pain reliever, and it will reference a form of the vitamin folic acid as a way to reduce symptoms of autism in some people, the Wall Street Journal reported Friday.
The report is said to highlight the pain reliever Tylenol, when taken during pregnancy, along with low levels of folate, a vitamin that is important for proper development of a baby’s brain and spine, as potential causes of autism, according to the Wall Street Journal. It will also name folinic acid, a form of folate also known as leucovorin, as a way to decrease symptoms of autism.
Folate supplements are already recommended for women during pregnancy to prevent neural tube defects, such as spina bifida, in infants.
Tylenol, which is the brand name of the generic pain reliever acetaminophen, is widely used in the US, including during pregnancy. Drugmaker Kenvue said in a statement Friday, “Nothing is more important to us than the health and safety of the people who use our products. We have continuously evaluated the science and continue to believe there is no causal link between acetaminophen use during pregnancy and autism.”
Experts generally agree.
“There is no clear evidence that proves a direct relationship between the prudent use of acetaminophen during pregnancy and fetal developmental issues,” Dr. Christopher Zahn, chief of clinical practice for the American College of Obstetricians and Gynecologists, said in a statement Friday. “Neurodevelopmental disorders, in particular, are multifactorial and very difficult to associate with a singular cause. Pregnant patients should not be frightened away from the many benefits of acetaminophen, which is safe and one of the few options pregnant people have for pain relief.”
The incidence of autism in the US is on the rise. About 1 in every 31 children was diagnosed with autism by age 8 in 2022, up from 1 in 36 in 2020, according to a US Centers for Disease Control and Prevention report published in April.
There are two primary reasons for the increase, according to Dr. Christine Ladd-Acosta, vice director of the Wendy Klagg Center for Autism at John Hopkins.
The first is that the definition of autism was broadened by the psychiatric community in 2013, so more people now qualify for an autism diagnosis.
Secondly, there has been a push for better screening of children, especially babies, for signs of autism. That push for increased awareness of the symptoms has been accompanied by a greater acceptance of the disorder, so people are not as afraid to seek help or to be identified as having autism, Ladd-Acosta said on the Johns Hopkins podcast “Public Health on Call.”
An HHS spokesperson said Friday that the agency is “using gold-standard science to get to the bottom of America’s unprecedented rise in autism rates. Until we release the final report, any claims about its contents are nothing more than speculation.”
Several studies have looked at the association between acetaminophen use in pregnancy and the development of autism in children, but experts say the science behind this theory is not settled.
A 2024 study published in JAMA looked at more than 2 million children born in Sweden between 1995 and 2019, about 185,000 of the whom were born to mothers who used acetaminophen during pregnancy. The study compared autism rates between these children with their siblings and with children who were not exposed, and it found that acetaminophen use during pregnancy was not associated with an increased risk of autism, attention deficit hyperactivity disorder or other neurodevelopmental disorders.
A meta-analysis published in August in the journal BMC Environmental Health looked at 46 studies on the use of acetaminophen during pregnancy and neurodevelopmental disorders in children. Six of the studies looked specifically at acetaminophen and autism. Overall, the analysis concluded that there was “strong evidence of an association” between taking acetaminophen during pregnancy and the development of autism in children, but the authors caution that their paper can show only associations, not that acetaminophen causes autism.
“We recommend judicious acetaminophen use — lowest effective dose, shortest duration — under medical guidance, tailored to individual risk–benefit assessments, rather than a broad limitation,” the researchers wrote.
The US Food and Drug Administration reviewed the risks of certain types of pain relievers during pregnancy in 2015 and said that all the studies it reviewed had methodological flaws. As a result, the agency said it would not change its recommendations for pain medications during pregnancy at that time.
The Society for Maternal-Fetal Medicine also reviewed the issue in 2017. It concluded that “the weight of evidence is inconclusive regarding a possible causal relationship between acetaminophen use and neurobehavioral disorders in the offspring.”
The Autism Science Foundation said in a statement Friday that “Any association between acetaminophen and autism is based on limited, conflicting, and inconsistent science and is premature given the current science. … The Autism Science Foundation strongly supports research into autism’s causes. More research needs to be done before alarming families or suggesting steps that may not actually reduce risk.”
HHS Secretary Robert F. Kennedy Jr. has previously promoted debunked theories linking vaccines to autism, and he pledged in April that his agency would have answers this month on the causes of autism. Thousands of researchers from top universities and institutions have applied for federal funding for autism research that Kennedy announced in April, and the US National Institutes of Health is expected this month to announce up to 25 awardees for the $50 million effort.
“We’re finding … certain interventions now that are clearly, almost certainly causing autism, and we’re going to be able to address those in September,” Kennedy said in a Cabinet meeting last month, to which President Donald Trump responded, “There has to be something artificial causing this, meaning, a drug or something.”
Dr. Peter Hotez, a pediatrician who co-directs the Center for Vaccine Development at Texas Children’s Hospital, said it would be irresponsible for Kennedy to cast any one or two things as a “smoking gun” cause of autism.
“That’s not how it works,” said Hotez, who has a daughter with autism and has written a book about the condition.
“We have autism genes, and it’s really important to look at some of the environmental toxins out there that are interacting with autism genes. And it may be possible to compile a list. … But I think it would be reckless to hone in just on those two, at least in terms of the publicly available data,” he said.
Shares of Kenvue fell about 10% midday after the Wall Street Journal report came out.
Dr. David Healy says
Does Tylenol In Pregnancy Cause Autism? Here’s What You Need To Know.
Forbes By Adaira Landry, MD MEd, Sep 06, 2025,
Health and Human Services Secretary Robert F. Kennedy Jr. is expected to release a report on the causes of autism, with particular attention to acetaminophen, the active ingredient in Tylenol, and its use during pregnancy.
In anticipation of this report, it is important for the public to understand physicians’ interpretation of current research and their clinical recommendations.
Does any current research prove acetaminophen causes autism?
It’s crucial to recognize that causation differs from association, correlation or link, terms often used in headlines that may create confusion. Association, correlation, or link means that two events happen together but may not be related. Causation means one event directly causes another. At this time, no studies show acetaminophen causes autism.
Dr. Franziska Haydanek, board certified ob/gyn speaks about Tylenol and pregnancy… \
“There are studies that have linked the use of acetaminophen in pregnancy with neurodevelopmental disorders, although there are conflicting studies about this association,” says board certified obstetrician-gynecologist, Dr. Franziska Haydanek.
A 2024 JAMA study did not demonstrate association with acetaminophen and autism for pregnant patients. However, a 2025 study describes an association between Tylenol use and neurodevelopmental disorders (NDDs), like autism, in 27 of the 46 studies they reviewed.
Dr. Shannon Clark, obstetrician-gynecologist and professor at UTMB-Galveston explains that, for the 2024 JAMA study, “when they looked at numerous different pain relievers in pregnancy, all were associated with neurodevelopmental disorders in offspring, but the associations went away in the sibling control analysis. This lends additional evidence t a genetic cause for NDDs.” In sibling-control studies, researchers compare outcomes between siblings in the same family, which helps account for shared genetics and environment. If an association disappears in this study design, it suggests the cause is more likely family-related factors, like genetics, rather than the medication itself.
Why is there conflicting research on this issue?
“The studies that do show an association have serious flaws and limitations as they do not control for confounding variables,” adds Clark. Confounding variables are hidden factors that influence both the exposure and the outcome. For example, if a pregnant woman takes Tylenol for a fever, the fever itself or the infection causing the fever could be the factor affecting autism risk.
“Another important point is even if we all agreed, according to these studies, that Tylenol is associated with autism, the difference in autism rates between those who took Tylenol and those who did not take Tylenol is very, very low. The vast majority of pregnant individuals who took Tylenol in the reported studies did not have children with autism.” says Clark. She reminds her patients that NDDs will remain challenging to attribute with one isolated culprit because they are multifactorial in origin with genetics playing a leading role.
How long have doctors been studying acetaminophen and autism?
Research exploring the relationship between acetaminophen and autism dates back to the early 2000s. “And 20 years later, we still don’t have any data that supports causation. While some of these studies show an association, none have proven that just taking even a singular dose of tylenol increases the rates of autism or ADHD in offspring,” says Haydanek.
Should pregnant women take acetaminophen when indicated?
According to the American College of Obstetricians and Gynecologists, “Acetaminophen remains a safe, trusted option for pain relief during pregnancy. Despite recent unfounded claims, there’s no clear evidence linking prudent use to issues with fetal development.”
Haydanek adds that she continues to recommend acetaminophen use as she does with any medication. “Use it when needed, in the lowest doses that achieve the desired outcome. We continue to recommend non-pharmaceutical treatments first, and if those do not work, Tylenol is one of our first line treatments in pregnancy for pain and for fevers.” She reminds patients that there are documented risks of maternal fevers.
The dosing for pregnant patients is standard: no more than 4,000 mg per day, typically dosed at 650 to 1000 mg every 4-6 hours.
Where do doctors stand with the current data?
“The current data is still not strong enough for me to consider not prescribing Tylenol in my patients where the benefits outweigh the risks. It’s a well tolerated medication, and one of the only ones we can use for pain and or fevers in pregnancy,” says Haydanek.
Clark adds, “as a Maternal-Fetal Medicine specialist, I say with confidence that pregnant individuals should not be afraid to take Tylenol when indicated. I will continue to recommend Tylenol as the first-line treatment for maternal fever and pain, for which it has known benefits. Untreated pain and fever have known adverse effects in pregnancy.”
What is most important to remember about autism?
Research should focus on identifying the true causes of autism rather than highlighting associations that may unnecessarily alarm for pregnant patients. Misinterpreted or overstated reports or research can undermine trust between patients and clinicians.
Efforts should also prioritize public education, reducing stigma, and strengthening support for families and schools caring for individuals with autism.
Dr. David Healy says
Debate Flares Over an Unproven Link Between Tylenol and Autism
Studies over the last decade of acetaminophen use in pregnancy — including a recent scientific review — have yielded mixed results but have not found a causal connection.
By Azeen Ghorayshi Sept. 5, 2025 New York Times
For more than a decade, scientists have asked whether acetaminophen — the active ingredient in the painkiller Tylenol — could affect fetal brain development, causing problems in children like autism and A.D.H.D. Some studies have suggested that there is a link; others have found none.
Now the latest study, a scientific review by researchers at Harvard’s T.H. Chan School of Public Health and the Icahn School of Medicine at Mount Sinai, has been swept into a larger, politically fraught debate about the causes of autism, spurred in part by the views of Robert F. Kennedy Jr., the Health and Human Services secretary.
There has been speculation that Mr. Kennedy may cite Tylenol use during pregnancy, among other environmental factors, as a potential cause of autism in an upcoming report.
The review that began the latest round of controversy, which examined 46 existing studies, eight of them looking specifically at autism, found there was evidence for a connection between acetaminophen use during pregnancy and neurodevelopmental disorders.
But the researchers who conducted the review cautioned that their conclusion did not mean acetaminophen caused autism, which mainstream scientists overwhelmingly agree is a result of a complex mix of genetic and environmental factors.
And the findings, other experts said, would not alter the advice doctors routinely give pregnant patients about acetaminophen use.
The conclusion of the review “doesn’t change a thing,” said Dr. Nathaniel DeNicola, an OB-GYN who advises the American College of Obstetricians and Gynecologists on environmental issues.
“The conclusion of the paper is that Tylenol should be used judiciously in the lowest dose, least frequent interval,” he said, “which is exactly the current standard of care for Tylenol and for so many medications, and really so many things we may encounter in pregnancy counseling.”
Researchers cannot conduct randomized controlled trials on pregnant women to definitively answer whether the drug causes problems in the developing fetus, because it would be unethical. The studies they reviewed were observational, analyzing data on the women’s pregnancies and then looking at how their children did over time.
Still, the findings circulated widely on social media this week, igniting alarm among parents and autism activists.
The right-wing provocateur Laura Loomer urged “everyone who has ever taken Tylenol or knows someone with autism” to take note, and suggested the common pain reliever could be a culprit behind the rising prevalence of autism diagnoses among children in the United States.
Since he has been in office, Mr. Kennedy has repeatedly said that he thinks genetics play a minimal role in autism, an assertion that autism researchers have vehemently disputed. Instead, he has argued that vaccines and other environmental factors are driving the increased incidence of the disorder in children.
The new report on acetaminophen, published in the journal Environmental Health, came out two weeks before Mr. Kennedy announced at a cabinet meeting that later this month he would be revealing new research findings on “certain interventions” that are “almost certainly causing autism.”
On X, Ms. Loomer speculated that the announcement might include findings about acetaminophen. Children’s Health Defense, the anti-vaccine advocacy group founded by Mr. Kennedy, has raised questions about acetaminophen and neurological problems in children.
But multiple health authorities that have examined the question of acetaminophen use — including the Food and Drug Administration, the European Medicines Agency and the Society for Maternal-Fetal Medicine — have said that the findings are inconclusive, meaning that there is no established risk.
In December 2023, a federal judge ruled against plaintiffs in a class-action lawsuit against Johnson & Johnson and other manufacturers of acetaminophen, citing a lack of scientific evidence for the claim that use of the drug during pregnancy caused autism and A.D.H.D. One author of the new report was an expert witness for the plaintiffs in the case.
Tylenol is the most widely used drug in pregnancy, and given that pregnancy is a crucial window for infant brain development, it continues to be important for researchers to investigate the drug’s potential impacts.
In a statement, Kenvue, the parent company of Tylenol’s manufacturer, said: “Nothing is more important to us than the health and safety of the people who use our products. We have continuously evaluated the science and continue to believe there is no causal link between acetaminophen use during pregnancy and autism.”
The company added, “Acetaminophen is one of the most studied medications in history.” Shares of Kenvue dropped precipitously on Friday after a news report that Mr. Kennedy would link the pain reliever to autism in the forthcoming announcement.
The new study did not provide any new data on the question of what happens when pregnant women take acetaminophen. Instead, it weighed the risk of bias in the existing studies and tried to synthesize the results.
More than half of the studies included in the review found that women who took acetaminophen while pregnant were at higher risk for having children with autism, A.D.H.D. or other neurodevelopmental disorders.
But the study’s authors cautioned that the finding did not mean that acetaminophen was causing autism: The women who took acetaminophen during pregnancy may also have differed in important ways from the women who did not.
“We cannot answer the question about causation — that is very important to clarify,” said Dr. Diddier Prada, an epidemiologist at Mt. Sinai who conducted the study.
He offered an analogy. “Ice cream sales go up in the summer and also violent crime increases during summer — these are associated, but it doesn’t mean that the ice cream is causing violent crime,” he said. “Both increase because of the hot weather.”
The right-wing provocateur Laura Loomer urged “everyone who has ever taken Tylenol or knows someone with autism” to take note.Credit…Greg Kahn for The New York Times
In the same way, women typically take acetaminophen because of health issues during their pregnancies, including infections and fevers, and those problems might increase the risk of neurodevelopmental problems. While many of the studies tried to control for such factors, it is unclear what other variables might not have been accounted for.
One major study published last year tried to take an even deeper look at what hidden factors may be driving the link. The researchers in the study looked at electronic medical records from nearly 2.5 million children in Sweden, finding a small positive association between women who used acetaminophen and the incidence of autism, A.D.H.D. and intellectual disability.
The team did a subsequent analysis to control for the mother’s genetics or pre-existing health issues. Comparing siblings who were exposed to acetaminophen during the mother’s pregnancy to those who were not, the researchers found no difference in the incidence of neurodevelopmental problems.
“Especially in the context of highly heritable developmental conditions like autism and A.D.H.D., genetics is the big unobserved elephant in the room,” said Brian Lee, associate professor of epidemiology at Drexel University and lead investigator of the study.
One smaller study out of Norway also used sibling-matched controls but found differing results based on how long the women recalled having taken acetaminophen during their pregnancies.
Mothers who took the pain reliever for more than 28 days for one of their pregnancies saw a twofold increase in the risk that their baby would have A.D.H.D. But mothers who took the pain reliever for one to seven days during pregnancy actually saw a lowered risk of such problems in their babies compared with siblings who were not exposed to acetaminophen at all.
The researchers said this showed that taking Tylenol for short-term use was better for the baby than, for example, leaving a fever untreated. “It’s protective,” said Eivind Ystrom, a senior researcher at the Norwegian Institute of Public Health and an author of the study. But, he added, “Don’t take it 28 days or more.”
All of the researchers agreed that what was needed to better understand the issue was higher quality research that included robust data on genetics, the dosages and the frequency with which acetaminophen was taken, as well as information on how frequently the pain reliever was administered to infants after they were born.
But researchers also said studies needed to take into account the many factors that contribute to autism.
“To simplify it and boil it down to, ‘It’s just acetaminophen’ is disingenuous and misleading,” said Alycia Halladay, chief science officer at the Autism Science Foundation.
“We know that autism is incredibly complex: It’s the result of genetics and environmental factors that affect the way people respond to the world,” she said. “I think we need to move away from studies that simplify it down to one exposure without any other considerations.”