Q&A: Pain Medication Expert on Controversy Surrounding Acetaminophen-Autism Link

Amid a slew of actions from the current presidential administration that has caused conflicting opinions in the health care community, its recent push to link acetaminophen (Tylenol) use with autism spectrum disorder has caused an outcry among health care professionals of various backgrounds. With a complex interplay between health care recommendations and presidential orders, many experts believe following the money is the best way to get answers.

“I had the question of why this medication was targeted in the first place,” Mark Garofoli, PharmD, BCGP, CPE, CTTS, clinical assistant professor at the West Virginia University School of Pharmacy and host of the Pharmacy Podcast Network’s Pain Pod, told Drug Topics. “Always follow the dollar.”

With all the reports, claims, and discussions circulating on this industry-impacting notion, Garofoli joined Drug Topics to help us better understand what is really happening between the federal government and the health care community. From financial kickbacks for supporting claims to the uncertainty that may lie ahead for millions of patients, he shared with us his initial thoughts on this unprecedented event regarding an over-the-counter product synonymous with the general public.

Garofoli discusses his initial reaction to the Trump Administration linking Tylenol use during pregnancy with autism spectrum disorder. | image credit: Nicole Kandi / stock.adobe.com

READ MORE: Trump Administration Claims Link Between Autism and Acetaminophen Use in Pregnancy

Drug Topics: What were your initial thoughts when you first heard about the Trump Administration’s announcement linking acetaminophen use in pregnancy with autism spectrum disorder?

Mark Garofoli: First, I had a ponderance of how long it would take licensed, trained, educated, and skilled health care professionals—and particularly our respective professional organizations—to respond. It wasn’t a question of if, rather, when. That response was impressive, to say the least, with countless health care professionals and organizations providing substantiated refuting statements and evidence.

Next, I had the question of why this medication was targeted in the first place. Always follow the dollar. In 2023, a multidistrict litigation (MDL) involving hundreds of plaintiffs in multiple court cases was dismissed due to a lack of evidence pointing towards autism causation. Interestingly enough, the corresponding author of this now infamous review article, and Dean of the Harvard School of Public Health, Andrea Baccarelli, received at least $150,000 for testifying against Tylenol’s manufacturer (Kenvue) in that 2023 MDL. Well, now there’s this review article, with all its debatable parts, lacking causation yet referencing correlation.^1,2

After the ‘why’ is the ‘where.’ Why wasn’t this controversial review article published in JAMA or the New England Journal of Medicine? Instead, it lies in ‘Environmental Health.’

Drug Topics: How are patients supposed to navigate these conflicting opinions regarding an over-the-counter drug that’s commonplace in pain management—not only for pregnant women but for patients of all characteristics?

Mark Garofoli: A typical mantra is to recommend one to talk with their health care professional, yet is that good enough? What if that professional is not well versed in scrutinizing studies, or worse yet, provokes their own personal opinions and views onto others. Perhaps we can recommend folks to listen to the respected expert groups making recommendations on the large scale, or at least those of us health care professionals that include both the positive and negative aspects (informed consent) in our discussions with individual patients.

Stay tuned for more from our interview with Garofoli, a regular contributor and expert for Drug Topics. In parts 2 and 3, he will dive deeper into the Tylenol and autism saga, the studies backing or denouncing this link, and what it all means for the greater health care community.

READ MORE: The Current State Of OTC Medication Use for Pain Management

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REFERENCES

1. Miller RV. Tylenol autism lawsuit. Lawsuit Information Center. September 21, 2025. Accessed September 25, 2025. https://www.lawsuit-information-center.com/tylenol-autism-lawsuit.html

2. Gerstein AS, Niederhelman EF. Harvard’s public health dean was paid $150,000 to testify Tylenol causes autism. The Harvard Crimson. September 24, 2025. Accessed September 25, 2025. https://www.thecrimson.com/article/2025/9/24/autism-dean-public-health/