Malone News

“We’re Going Bold to Tackle Autism”

Speaking from the Roosevelt Room today, President Donald J. Trump and U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. announced bold new actions to confront the nation’s autism spectrum disorder (ASD) epidemic, which has surged nearly 400% since 2000 and now affects 1 in 31 American children.

“For too long, families have been left without answers or options as autism rates have soared,” Secretary Kennedy said. “Today, we are taking bold action—opening the door to the first FDA-recognized treatment pathway, informing doctors and families about potential risks, and investing in groundbreaking research. We will follow the science, restore trust, and deliver hope to millions of American families.”

First, the U.S. Food and Drug Administration (FDA) will act on a potential treatment for speech-related deficits associated with ASD. The FDA today is publishing a Federal Register notice outlining a label update for leucovorin for cerebral folate deficiency, which has been associated with autism. This action establishes the first FDA-recognized therapeutic for children with cerebral folate deficiency and autistic symptoms.

The change will authorize treatment for children with ASD, with continued use if children show language, social, or adaptive gains. Following the label update for ASD, state Medicaid programs will be able to cover leucovorin for the indication of ASD, in partnership with the Centers for Medicare & Medicaid Services (CMS). Finally, the National Institutes of Health (NIH) will launch confirmatory trials and new research into the impact of leucovorin including safety studies.

While promising, it is important to note that leucovorin is not a cure for ASD and may only lead to improvements in speech-related deficits for a subset of children with ASD. Furthermore, this treatment must be administered under close medical supervision and in conjunction with other non-pharmacological approaches for children with ASD (e.g., behavioral therapy).

“As a physician, I have seen how devastating autism spectrum disorder can be for children and their families,” CMS Administrator Dr. Mehmet Oz said. “Today’s actions represent an unprecedented, comprehensive approach to deepen our understanding of the causes of autism, share what we know and don’t know based on current research, and ensure that every child has a better chance to thrive. By providing access to a drug to treat symptoms associated with autism, we are providing hope to families and providers who have until today had very limited options.”

Second, HHS will act on acetaminophen. Today, the FDA will issue a physician notice and begin the process to initiate a safety label change for acetaminophen (Tylenol and similar products). HHS will launch a nationwide public service campaign to inform families and protect public health.

The FDA is responding to prior clinical and laboratory studies that suggest a potential association between acetaminophen use during pregnancy and adverse neurodevelopmental outcomes. FDA also recognizes that there are contrary studies showing no association and that there can be risks for untreated fever in pregnancy, both for the mother and fetus.

Given the conflicting literature and lack of clear causal evidence, HHS wants to encourage clinicians to exercise their best judgment in use of acetaminophen for fevers and pain in pregnancy by prescribing the lowest effective dose for the shortest duration when treatment is required. Furthermore, FDA recognizes that acetaminophen is often the only tool for fevers and pain in pregnancy, as other alternatives (e.g., NSAIDs) have well documented adverse effects. FDA is partnering with manufacturers to update labeling and drive new research to safeguard mothers, children, and families.

“A growing body of evidence suggests that some children suffering from autism are folate deficient within the brain—a problem that can be treated with leucovorin,” FDA Commissioner Dr. Marty Makary said. “Given the extent of the current autism epidemic, physicians should immediately have this treatment option available for candidate children. We are also sharing new information about the potential risks of acetaminophen so patients can make a more informed decision with their health care provider.”

Third, NIH today is announcing the recipients of the Autism Data Science Initiative (ADSI), funding 13 projects totaling more than $50 million to transform autism research. ADSI integrates large-scale biological, clinical, and behavioral data with an exposomics approach that examines environmental, nutritional, medical, and social factors alongside genetics.

Projects employ advanced methods such as machine learning and organoid models, address both children and adults across the lifespan, and establish replication hubs to ensure rigor. Each project includes community engagement to align research with the needs of autistic individuals, families, and clinicians.

“Millions of American families who care for autistic kids need scientists to apply gold standard science, expertise, and open minds to figure out how to help these kids,” NIH Director Dr. Jay Bhattacharya said. “With the Autism Data Science Initiative, NIH is harnessing cutting-edge science to uncover the root causes of autism. We are building knowledge that can improve lives and restore hope for families.”

By Nicolas Hulscher, MPH

The pathway to developmental regression begins with vaccines, not acetaminophen.

Today the White House and HHS announced a potential link between prenatal acetaminophen (Tylenol) use and autism spectrum disorder (ASD), along with new actions to limit its use.

In a MAJOR development, both Trump and RFK Jr. also acknowledged the possibility that vaccines contribute to autism. As Trump said:

“They pump so much stuff into those beautiful little babies, it’s a disgrace.”

Although most of the spotlight fell on Tylenol, the evidence is undeniable: acetaminophen is NOT the root cause. At most, it weakens defenses and heightens vulnerability. The true trigger — then and now — is VACCINES.

The Evidence

Prenatal Exposure

The most comprehensive review to date, by Prada et al, evaluated acetaminophen use during pregnancy:

• 27 studies found a positive association with neurodevelopmental disorders (ASD/ADHD).
• 9 studies showed no link.
• 4 studies suggested protective effects.

Autism was never diagnosed at birth. In every study, it emerged years later—typically ages 2–8, the very same window when children are loaded with a battery vaccines. None of these papers accounted for vaccination as a confounder. This shows prenatal Tylenol exposure may predispose children, but the neurological injuries are detected during the vaccine years.

Postnatal Exposure

Schultz et al (2008): Children given Tylenol after MMR vaccination were about six times more likely to later be diagnosed with autism. In those who regressed (lost previously acquired skills), the risk was nearly fourfold, and in those with clear post-vaccine complications, the risk spiked to over eightfold. By contrast, ibuprofen showed no association.

Yengst et al (2025): In a Medicaid cohort of 674,000+ children, repeated episodes of fever, ear infections, or other “Tylenol-triggering” illnesses were linked to a 2½-fold higher risk of autism. Among girls with multiple fevers, the risk climbed to nearly fourfold.

Taken together, these studies reveal a consistent pattern: autism risk intensifies in the post-vaccine period, when febrile reactions are most common, and acetaminophen use in this context may amplify the likelihood of developmental regression.

Acetaminophen depletes glutathione, the body’s master antioxidant/detox system, exactly when the brain faces inflammatory/oxidative stress (e.g., fever, seizure, immune activation). Some pediatric practices have even recommended Tylenol before vaccine visits “just in case,” meaning kids arrive with defenses already depleted as the shots provoke fever/immune activation—priming them for worse outcomes.

Confounding by Indication

Tylenol is rarely given at random. It is usually given because a child has spiked a fever or suffered a seizure — often after vaccination. This creates what’s known as confounding by indication: the very reason for giving Tylenol (a serious post-vaccine reaction) is already linked to elevated risk.

Across studies, a clear pattern emerges:

• Diagnoses cluster in early childhood (ages 2–8), the most intensive vaccine years.
• Greater fever/illness burden — situations when Tylenol is typically used — corresponds to higher odds of autism.
• Regression subgroups show the largest risks following vaccination (Schultz).

Together, the evidence points to vaccination as the trigger, with Tylenol lowering defenses by depleting glutathione and thereby magnifying the neurologic damage.

Timeline Reality

• Tylenol was released in the 1950s. Autism rates stayed flat.
• The surge began in the late 1980s and 1990s, exactly when the childhood vaccine schedule doubled and tripled.

If Tylenol alone were the driver, autism would have spiked in the 1950s. It didn’t.

The Missing Evidence

• There are no case reports of regression to autism from acetaminophen alone.
• By contrast, there are thousands of parental reports and multiple peer-reviewed studies documenting developmental regression after vaccination.

Nonetheless, today’s announcement has opened the door for an official investigation into the glaring link between childhood vaccination and autism.

At the McCullough Foundation, we are finalizing one of the most comprehensive analyses ever conducted on the causes of autism — untainted by fraud, bias, and corruption. You can rest assured that all risk factors will be included, INCLUDING VACCINES.

No stone will be left unturned — and no protected interest will be spared.

Nicolas Hulscher, MPH

Epidemiologist and Foundation Administrator, McCullough Foundation

Support our mission: mcculloughfnd.org

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