Trump’s claims on autism disputed by medical experts and autism patient advocates

by ECM | September 28, 2025 10:01 pm

By Alexander J. Schorr

Miriam Raftery contributed to this report

September 28, 2025 (Washington D.C.) — The Food and Drug Administration (FDA) has just approved[1] a version of Leucovorin for autism treatment of children. This action comes after President Donald Trump claimed that Tylenol taken during pregnancy can cause autism, despite the fact that numerous studies have found Tylenol safe to take during pregnancy to reduce pain and fever—conditions that left untreated can damage an unborn child.

Meanwhile Robert F. Kennedy Jr., secretary of Health and Human Services, has promised to prioritize finding causes and a cure for autism soon.  Kennedy has drawn fire from the Autistic Self Advocacy Network[2] for promoting “unethical junk science and dangerous misinformation” about autism.

The organization also criticizes Kennedy for hiring “quack” David Geier[3] to oversee an HHS study on autism. Geier lost his medical license in nine states, was disciplined for practicing medicine without a license and for, along with his father, “subjecting autistic children to unproven medical treatments for their own financial gain.” 

Leucovorin

The Trump administration is hailing Leucovorin, a form of folic acid[4], for reducing some autism symptoms, but experts who research or treat autism almost uniformly agree that the medication should be studied further before it’s rolled out to children or adults. Leucovorin[5] is used as an antidote to the harmful effect of Methotrexate[6] (a cancer medicine) that is given in high doses— it is also used along with Fluorouracil[7] (another cancer medicine) to treat colon or bowel cancer. It is also used to prevent certain kinds of anemia; Leucovorin acts in a similar way as folic acid in the body, which can be low in patients being treated with methotrexate.

Conflict of interest questions have been raised over whether Dr. Mehmet Oz, the administrator for the Centers for Medicare & Medicaid Services (CMS), may profit off this action. Oz invested in iHerb,  a company that sells folinic acid, the supplement found in leucovorin. While the FDA approval is only for a prescription version, Oz could potentially profit off supplements touting natural alternatives.  Oz has said he will divest his shares of the company, but may already have profited off the announcement.

Tough Leucovorin has shown promise in some small-scale trials, David Mandell, a psychiatry professor at the University of Pennsylvania, told NBC News[8] the folate hypothesis is based on relatively weak science. “We do not have good, large-scale studies that show that any significant portion of autistic people have a folate deficiency,” he said.

Before Leucovorin can become available to qualifying patients via prescription, the manufacturer must first submit an application to the FDA for new labeling requirements.

Controversy Over Tylenol

President Trump urged Americans not to use over-the-counter Acetaminophen, the active ingredient in Tylenol, during pregnancy, stating that it had links to autism, but he did not provide sufficient scientific evidence to back up this claim. In addition to claiming that there was “virtually no autism” amongst the Amish or Cubans, he also repeated disproved[9] and debunked claims[10] about vaccines causing autism, with Vedika Bahl fact-checking these claims in Truth or Fake.

When the Trump administration claimed that there was a link between Tylenol and autism, the scientists behind a study cited by the President, which included those from Harvard University’s Chan School of Public Health, emphasized that more research is needed to confirm any association. They asserted that Tylenol remains a useful tool for pregnant patients, and recommend its use in small doses and for short periods of times.

Trump’s claim has been swiftly refuted by the American College of Obstetricians and Gynecologists,[11] which issued a statement reading in part: ““In more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children. In fact, the two highest-quality studies on this subject—one of which was published in JAMA[12] last year—found no significant associations between use of acetaminophen during pregnancy and children’s risk of autism, ADHD, or intellectual disability.”

The ACOG statement continues, “The studies that are frequently pointed to as evidence of a causal relationship, including the latest systematic review released in August, include the same methodological limitations—for example, lack of a control for confounding factors or use of unreliable self-reported data—that are prevalent in the majority of studies on this topic.

Doctors warn that fever can be a risk during pregnancy and that fever medications like Ibuprofen can cause miscarriages. Additionally, fevers can pose a risk to unborn children and can cause neural tube defects.

Doctors already discourage pregnant women from taking ibuprofen (the active ingredient in Motrin and Advil) because of a known risk of birth defects, while aspirin can cause bleeding. That leaves acetaminophen— or Tylenol, the only commonly used over-the-counter drug approved to treat pain relief and fevers during pregnancies.

According to KFF Health News[13], Autism experts at the CDC were neither consulted nor asked to review a draft of the findings and recommendations by the White House team’s[14] long-awaited autism announcement. One CDC researcher, who wished to remain anonymous for fear of retaliation, said “typically, we’d be asked to provide information and review the report for accuracy, but we’ve had no contact with anyone— it is very unusual.”

Health experts from around the globe are joining in a unison of doctors and organizations pushing back against the Trump administration’s announcement[15] about the cause of autism and pregnancy complications by Tylenol and many other cold and flu medications. Needless to say, Autism was officially labeled and defined in 1911[16], and Tylenol was invented in 1950.

The Role of Autism Spectrum Disorder

The group Autism Speaks[17] provided a statement illustrating the need for further testing, which illustrated that even though certain scientific examples of leucovorin improving speech in minimally verbal children, “well-controlled clinical trials are still needed to confirm its efficacy and safety as a therapeutic treatment.”

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by persistence issues in social communication, interactions, and restricted and repetitive patterns of behavior like social or physical “ticks” and physical nuances. According to the Center for Disease Control, autism signs and symptoms emerge in the first year of life and can be detected between six and eighteen months of age.

According to a report[18] released by the CDC, autism incidence in the US has increased from 1 in 36 children in 2020 to 1 in 31 in 2022; the “Get the Facts Data Team[19]” gave context behind the report in providing the numbers and statistics of the report.

After Trump’s announcement, the Food and Drug Administration (FDA) shared an open letter[20] encouraging physicians to “consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers.” The letter stated that “while an association between acetaminophen and autism[21] has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature.”

The letter also stated that physicians should balance the possible risks of acetaminophen with the fact that taking it is still safer than other over-the-counter painkillers and fever-reducers during pregnancy like aspirin and ibuprofen. This announcement came after Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. stated back in April that the HHS would undergo a “massive testing and research effort” to determine the cause of autism[22]. Although Kennedy said that he intended to release his report in September, the National Institutes of Health Director Dr. Jay Bhattacharya stated later in the month that it could be as long as a year before the findings are released.

What We Know About Tylenol

Tylenol[23], which contains the ingredient acetaminophen, is a widely used over-the-counter medication for fever and pain relief. Misusing Tylenol, especially in exceeding the recommended dosage, can cause severe and potentially fatal liver damage.

A study from JAMA[24] found that acetaminophen, the active ingredient on Tylenol, during pregnancy was not connected with the increased risk of autism, ADHD, or intellectual disabilities in children, refuting recent research papers[25] stating the opposite. The study, which was funded by the National Institutes of Health (NIH) and conducted by the Karolinska Institute in Sweden and Drexel University— the largest of its kind, analyzed data from almost 2.5 million Swedish children born between 1995 and 2019.

Children of these parents are also more likely to have a neurodevelopmental disorder, but this is not necessarily due to exposure to acetaminophen, but rather due to high heritability of these disorders. Acetaminophen exposures are most common among children born to children in lower socioeconomic class, with a higher early pregnancy body mass index, those who smoked during pregnancy and those with psychiatric disorders. One limitation of this study is that it relies on prescription data and self-reporting, however with a large sample size and ability to control for external variables, the conclusions of this study are much more robust and well-supported by evidence that is consistent with the scientific community.

What is Known about Autism

Autism, also known as autism spectrum disorder (ASD[26]), is a condition characterized by differences or difficulties in social communications and interactions, a need or strong preference for predictability and routine, sensory processor differences, and repetitive behaviors. There is no cure for autism spectrum disorder, but being informed and getting treatment early— especially during the preschool years, can make a big difference on many children with the condition.

Some children show signs of autism spectrum disorder in early infancy, such as less eye contact, not responding to their names, or being disinterested in caregivers. Later on, they can become more withdrawn, aggressive, or lose key language skills that they had before— usually seen by ages 2 to 3 years old. Some people in the mild range of the autism spectrum may only notice symptoms until later on, such as into the middle or late stage of childhood where there is a greater need to communicate or socialize.

Some children will have trouble learning, and these children will range from lower to higher levels of intelligence. These children can learn quickly, but will have trouble communicating or applying what they know in everyday life and adjust to social situations. Since each child can have a unique mix of symptoms generally based on how severe the condition is:

 

• Have poor eye contact and little expressions on their faces.
• Don’t respond to their name.
• Don’t want to be cuddled or prefer to play alone and retreat away.
• Don’t speak or have delayed speech or lose the ability to say words or sentences as they could before.
• Have difficulty starting a conversation or keep one going.
• Speak with an unusual tone or rhythm and may use a singsong voice or robot-like speech.
• Repeat words or phrases word for word but don’t know how to use them.
• Have difficulty understanding questions or directions.
• Don’t show emotions or feelings and don’t seem to be aware of how others feel.
• Are passive, aggressive or disruptive when interacting with others.
• Have a hard time figuring out what it means when people have different looks on their faces, position their bodies differently or speak in different tones of voice.
• Making repetitive movements over and over again like rocking, spinning or hand-flapping.
• Do activities where they can cause harm to themselves like biting or head-banging.
• Have unusual or exaggerated body language.
• Are quite sensitive to light, sound or touch, but may not be affected by forms of pain or temperature.
• Create specific routines or rituals and become upset at even small changes and alterations.
• Are fascinated by details of an object, often fixating on a substance or activity with unusual intensity or focus.
• Prefer specific foods, such as eating only a few foods or not wanting to eat foods with certain textures.

 

Cause of Autism and Treatments

There is no single cause for autism[27], though ASD is believed to result from multiple factors like environmental, genetic, and nongenetic factors.

At one point during the 1940s and 1950s, autism was erroneously blamed on mothers with a “cold” parenting style, and that their children developed autism because of their mothers.

From a genetic standpoint, studies on identical twins show that autism has a strong genetic basis, with research showing that having a sibling with autism increases a child’s risk to develop the disorder. Chromosomal conditions like Fragile X or Rett syndrome are also highly correlated with an autism diagnosis. Children born to older parents also seem to have a higher risk for developing autism.

Children living close to farming areas or highways seem to have higher rates of autism. There is a lot of research being conducted on possible environmental factors, including toxins like air pollution, exposure to pesticides and heavy metals.

There is no medical autism test similar to a blood test in order to diagnose ASD[28]. Instead, experienced medical professionals will examine a person’s developmental history and behaviors, and will interview and observe the person and their loved ones, often using professional screening.

While an autism diagnosis can only be given by a health care professional, there are several screening tools that can alert parents, patients, and caregivers:

 

• The M-CHAT-R is a free parent-completed questionnaire[29] about your child’s behavior. You can use the results of the screener to discuss any questions that you may have with your child’s healthcare provider.
• The SACS-R and SACS-PR are autism screening tools developed by La Trobe[30] University and are designed to identify behaviors that are characteristic of children on the spectrum from as young as 12 months old through preschool. This tool is meant to be administered by a trained psychologist, early childhood educator, and allied health professional.
• The Southwest Autism Research & Resource Center’s (SARRC[31]) screening questionnaire, developed to be taken by parents, educators, and medical professionals, can identify children who may have symptoms that were once characterized as Asperger syndrome, now level 1 ASD.
• The Autism Spectrum Quotient Test[32] is a self-administered 50-question questionnaire used to measure autistic traits in adolescents and adults ages 16 years and older. The questionnaire is suitable for people with an IQ over 80.

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