Autism, Acetaminophen, and Misleading Claims

I am not an expert on autism. However, I am concerned about the administration’s recent recommendations regarding acetaminophen and autism. Even scientists who have suggested a possible link have NOT recommended stopping the use of acetaminophen during pregnancy.

It is well-recognized that autism is related to multiple factors, both genetic and potential environmental factors. The use of acetaminophen, even if linked to autism, could represent an epiphenomenon in which a primary disorder (like a fever or infection) is responsible for subsequent neurodevelopmental problems rather than the medicine itself. While there has been growing concern about the increasing frequency of autism, much of this relates to changes in the definition of autism over various periods.

I recommend the following recent sources of information on this topic:

From ACOG -an excerpt:

“Today’s announcement by HHS is not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children. It is highly unsettling that our federal health agencies are willing to make an announcement that will affect the health and well-being of millions of people without the backing of reliable data.

“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 last year—found no significant associations between use of acetaminophen during pregnancy and children’s risk of autism, ADHD, or intellectual disability. 

“Acetaminophen is one of the few options available to pregnant patients to treat pain and fever, which can be harmful to pregnant people when left untreated. Maternal fever, headaches as an early sign of preeclampsia, and pain are all managed with the therapeutic use of acetaminophen, making acetaminophen essential to the people who need it. The conditions people use acetaminophen to treat during pregnancy are far more dangerous than any theoretical risks and can create severe morbidity and mortality for the pregnant person and the fetus.”

From KFF News:

In August, Bauer and her colleagues published an analysis of 46 previous studies on Tylenol, autism, and attention-deficit/hyperactivity disorder. Many found no link between the drug and the conditions, while some suggested Tylenol might occasionally exacerbate other potential causes of autism, such as genetics.

Bauer, an epidemiologist at the University of Massachusetts-Lowell, and her team called for more judicious use of the drug until the science is settled.

Autism experts at the Centers for Disease Control and Prevention were neither consulted for the White House’s long-awaited autism announcement nor asked to review a draft of the findings and recommendations…

If prenatal Tylenol has any association, which it may not, it would help account for only a fraction of cases, she said. Further, research has not deeply examined Tylenol risks in young children, and many rigorous studies refute a link between vaccines and autism.

Bauer worries such statements will cut both ways: People may put themselves at risk to avoid vaccines and Tylenol, the only safe painkiller for use during pregnancy. And she frets that scientists might outright reject her team’s measured concerns about Tylenol in a backlash against misleading remarks from Trump and other members of his “Make America Healthy Again” movement….

Helen Tager-Flusberg, director of the Center for Autism Research Excellence at Boston University, called Trump’s comments dangerous. Fevers can harm the mother and the developing fetus, she said, adding that fevers are more strongly associated with autism than Tylenol…

Several medical and scientific associations have called for Kennedy’s removal or resignation. Many scientists are skeptical of what he says because much of it has been misleading or wrong. For example, he’s said HIV isn’t the only cause of AIDS (it is), that antidepressant drugs cause mass shootings (they don’t), that older adults don’t have severe autism (some do), that the measles vaccine causes brain swelling (it doesn’t), that covid vaccines were the deadliest vaccines ever made (they aren’t), that vaccines aren’t safety-tested (they are), and that vaccines contribute to autism (they don’t).

From the Wall Street Journal:

Washington Post Editorial:

From TIME article: “Despite what we are now hearing from the most powerful health offices in the nation, the science on acetaminophen and autism remains unsettled. What is not unsettled is the damage done when politics masquerades as medicine. Every false certainty erodes the trust that holds the fragile bridge between patients and their doctors. Break that trust, and no study, no drug, no vaccine will be enough to save lives when the next real crisis comes. When politicians play doctor, it’s families who will pay the price.”

My take: Thinking about the damage from this press conference, I was reminded of a scene from the movie “Doubt.” In the movie Doubt, Father Flynn (played by Philip Seymour Hoffman) tells a parable about an old priest instructing a woman who has been gossiping to take a pillow, cut it open on her roof, and then return to gather up all the feathers. When she tells him it can’t be done because “the wind took them all over,” the priest responds: “And that… is gossip!”

The spreading of damaging rumors and lies, which is being done by leaders of this country, is impossible to contain or undo once released, and its impact is far-reaching and destructive. 

Related blog posts:

The Future of Vaccine Policy in America with Politicized ACIP

HY Chu et al. NEJM 2025; 398: 817-822. The Path Forward for Vaccine Policy in the United States

This commentary was published on 7/30/25 and was written by the 17 voting members of the ACIP who were dismissed.

Key points:

  • For over 60 years, the Advisory Committee on Immunization Practices (ACIP), which comprised a diverse group of nonpartisan specialists, has advised the Centers for Disease Control and Prevention (CDC) on vaccine recommendations based on science and intensive review of evidence. The abrupt dismantling of the rigorously vetted process and the replacement of the Committee with an inexperienced and biased panel has engendered fundamental distrust in the Committee’s vital work…The government has abruptly changed vaccine policy through social media postings and publications in news media.
**VRBPAC denotes FDA’s Vaccines and Related
Biological Products Advisory Committee
  • The ACIP has been an independent committee of vaccine scientists and clinicians that has relied on a process called the Evidence to Recommendations framework. This deliberative framework calls for a review of the strength of evidence around a variety of factors, including the magnitude of the public health problem, potential benefits and harms, values, acceptability, resource use, equity, and feasibility.
  • Previously, the ACIP had well-defined and stringent conflict of interest standards.  Voting members had to disclose and actively manage any actual or apparent conflicts of interest before and throughout their tenure… ACIP members disclosed any potential conflicts during each vote and could not vote on issues where they had an ongoing conflict.
  • ACIP recommendations have many implications. For example, government-run medical systems such as the Veterans Health Administration may be able to provide only vaccines consistent with ACIP recommendations…For children who are uninsured, underinsured, Medicaid-eligible, American Indian, or Alaska Native, the Vaccines for Children program pays only for ACIP-recommended vaccines; about half of children in the United States get their vaccines through this program.
  • The nation now faces a scenario in which the rigor and discipline of these vaccine recommendation processes are rapidly eroding…Three major issues are of particular concern: the quality and availability of data; straightforward guidance for providers and the public; and insurance coverage and vaccine access, uptake, and equity.
  • The absence of a cohesive federal policy produced by means of an evidence-based, expert-informed process creates the very real potential for conflicting messaging from within the Department of Health and Human Services (DHHS) or in relation to messages from nongovernmental agencies, such as professional organizations. This lack of coordination is likely to cause confusion for providers and the public, vaccine-administration errors, decreased uptake of vaccines, and further erosion of an already damaged public trust. It is also likely that in this milieu, misinformation will flourish.
  • The ACIP cannot be replaced, but it may be possible to limit the damage. In this vacuum, it is urgent that other organizations step forward to reassert an evidence-based, expert approach to vaccine recommendations to bring the nation back from the precipice of uncontrolled spread of infectious diseases and needless deaths.

My take: The advice from governmental agencies has been compromised. With regard to vaccines, instead of a transparent process with expertise, we are left with partisan recommendations with questionable credibility.

Related blog posts:

 

AI for GI

This month’s Gastroenterology issue is devoted solely to the use/expected uses as well as risks of artificial intelligence (AI) for gastroenterology and hepatology.

DL Shung, M Iacucci. Gastroenterol 2025; 169: 391-392. Artificial Intelligence in Gastroenterology and Hepatology: Potential and Perils

An excerpt:

“AI is reshaping the landscape of gastroenterology and hepatology with the promise of better, faster, more objective, and standardized care of delivery. However, behind the algorithms lies a more insidious risk: the erosion of trust in human providers…Information risk …include both error commission (ie, when the models generate false statements, introduce nonsensical concepts, or fabricate sources) and error omission (ie, summaries that omit critical information)…

When AI becomes the center of care, patients may perceive their doctors as intermediaries…diminishing the therapeutic effect of the patient-physician relationship…This arrangement can dilute clinical training, increase physician burnout, and lead to medicolegal implications…Other risks include perpetuating bias from nonrepresentative training data and amplifying uncertainty of AI due to lack of real-world validation…

We hope that AI systems will allow us to spend more, not less, time with patients and empower us to provide personalized care by leveraging high-quality multimodal data.”

Most of the articles are behind a paywall in this issue. There are five that are open access articles:

My take: These articles provide a good deal of information about the applications and risks of AI. In my view, physicians will be needed more than ever to help interpret/manage the huge amount of information available.

Related blog posts:

Warnings of Hepatitis B Vaccine Policy Shift

Despite the enormous benefits of hepatitis B vaccination, it appears that this administration has its sights on changing the policy of administration at birth.

NY Times 9/16/25: C.D.C. Vaccine Advisers May Limit Hepatitis B Shots for Newborns

An excerpt:

Committee members, some of whom are vaccine skeptics, are likely to recommend restricting the use of the shots at birth or delaying them until later in childhood…

“Unless the mother is hepatitis-B-positive, an argument could be made to delay the vaccine for this infection,” Martin Kulldorff, the committee’s chair, said at its previous meeting in June.

Vaccine experts at the C.D.C., who normally would be deeply involved in preparing for this week’s meeting, have been sidelined and given no more information than the public about the meeting’s agenda or possible outcomes…

Before 1991, when newborns were not all vaccinated for hepatitis B, about 20,000 babies became infected each year. Routine immunization at birth cut the number of newborn infections … There are now fewer than 20 children per year who acquire the disease from their mothers.

Only about half of the cases before 1991 were a result of transmission from an infected mother. The other half “weren’t getting it from becoming sex workers, and they weren’t getting it from being intravenous drug users,” Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said…

From 2015 to 2017, about 21,000 infants were born to pregnant women with hepatitis B antibodies, but fewer than half were identified through prenatal screening, according to the C.D.C.

My take: If routine immunization at birth is stopped, there will be a lot more hepatitis B infections and subsequent complications. Some infections will be acquired at birth and some later due to missed opportunities to provide protection later on.

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Brooklyn Botanic Garden

Is Lactated Ringer’s Better Than Normal Saline For Routine Use?

L McIntyre et al. NEJM 2025; 393: 660-670. A Crossover Trial of Hospital-Wide Lactated Ringer’s Solution versus Normal Saline

Background: “A single-center, multiple-crossover trial involving noncritically ill patients in the emergency department found that balanced crystalloid fluids were associated with a lower incidence of major adverse kidney events at 30 days than normal saline. A systematic review of 13 randomized, controlled trials comparing balanced crystalloids with normal saline in a total of 35,884 critically ill participants showed no significant difference in mortality (17.4% with balanced crystalloids and 18.2% with saline; relative risk, 0.96; 95% confidence interval [CI], 0.91 to 1.01) or in the incidence of the use of renal replacement therapy (5.6% and 6.0%, respectively; relative risk, 0.95; 95% CI, 0.81 to 1.11) in trials with a low risk of bias.4 However, the investigators in that analysis and those in another patient-level meta-analysis involving a Bayesian approach concluded that there is a high probability that balanced crystalloids are associated with lower in-hospital mortality and a lower incidence of the use of renal replacement therapy than normal saline.5

Methods of th “FLUID” trial: 3 hospitals used lactated ringer’s (LR) and 4 hospitals used normal saline throughout hospital setting for 12 weeks. Then after a 1-2 week washout period, the hospitals switched to the other fluid for 12 weeks.

Key finding:

Discussion: “A limitation of this trial was the inability to recruit the total of 16 hospitals as originally planned owing to the Covid-19 pandemic. Hence, the trial had less power to detect differences that were small — but important to patients — at the level of the hospital or health care system…Our findings align with those of recent meta-analyses of randomized, controlled trials that suggest a small but clinically relevant reduction in mortality with balanced crystalloids as compared with normal saline.”

My take: This study did not show a significant difference in death or readmission at 90 days. Yet, lactated ringer’s is probably just a bit better fluid for most adult patients. In the pediatric population, more studies are needed.

Related blog posts:


Disclaimer
: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician.  Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition

Weight Loss Efficacy of Cagrilintide and Semaglutide

WTGarvey et al. N Engl J Med 2025;393:635-647. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity

This  phase 3a, 68-week, multicenter, double-blind, placebo-controlled and active-controlled trial (REDEFINE 1) examined the efficacy of the combination of Cagrilintide and Semaglutide (known as CagriSema).  Patients had a body-mass index (BMI) of 30 or higher or a BMI of 27 or higher with at least one obesity-related complication. The combination druge was delivered as a fixed-dose in a single-dose, single-use pen device. 6.1% of trial participants had BMI <30.


Percentage of patients with at least 5% weight loss
Percentage of patients with at least 20% weight loss
  • “Gastrointestinal adverse events (affecting 79.6% in the cagrilintide–semaglutide group and 39.9% in the placebo group), including nausea, vomiting, diarrhea, constipation, or abdominal pain, were mainly transient and mild-to-moderate in severity.”
  • “Although 57.4% of the participants assigned to cagrilintide–semaglutide were receiving the maximum dose at 68 weeks, 74.7% had received the maximum dose at some point after randomization…doses below the target might be highly effective for some patients and that dose reductions based on the clinical judgment…may be appropriate.”

This same issue also examined the use of this combination in patients with type 2 diabetes (REDEFINE 2). in this study with 1206 patients, “the estimated mean change in body weight from baseline to week 68 was −13.7% in the cagrilintide–semaglutide group and −3.4% in the placebo group.”

The editorial by CM Hales (“Expanding the Treat-to-Target Toolbox for Obesity and Diabetes Care”) notes that “six deaths occurred in the two trials combined, all in the cagrilintide–semaglutide groups, including one suicide in each trial. Previous studies of suicidality with GLP-1 receptor agonist treatment have not supported a causal link,6 but it continues to be of concern.”

My take (from the editorial): “A sustainable treat-to-target approach should extend to lifelong maintenance of health gains after initial weight loss. The intensity and composition of lifestyle interventions in the context of highly effective pharmacologic therapies also need further study. The pharmaceutical pipeline is promising, with potential improvements in safety (such as preservation of lean mass) and more convenience for patients (such as oral administration and monthly dosing). Greater effects on the health of Americans may be achieved not with antiobesity medications producing ever greater magnitudes of weight loss but with expanded access to safe and effective therapies for those who would most benefit.”

Related blog posts:

Rising Scientific Fraud: Threats to Research Integrity Plus One

Excerpts from NY Times Article:

“A team of researchers found evidence of shady organizations churning out fake or low-quality studies on an industrial scale. And their output is rising fast, threatening the integrity of many fields…“If these trends are not stopped, science is going to be destroyed,” said Luís A. Nunes Amaral, a data scientist at Northwestern University and an author of the study”

““Science relies on trusting what others did, so you do not have to repeat everything,” Dr. Amaral said….By the 2010s, journal editors and watchdog organizations were warning that this trust was under threat. They flagged a growing number of papers with fabricated data and doctored images. In the years that followed, the factors driving this increase grew more intense.”

“As more graduate students were trained in labs, the competition for a limited number of research jobs sharpened. High-profile papers became essential for success, not just for landing a job, but also for getting promotions and grants. Academic publishers have responded to the demand by opening thousands of new scientific journals every year…”

“Organizations known as paper mills are now turning scientific fraud into a lucrative business. Scientists eager to pad out their resumes can pay hundreds to thousands of dollars to be named as an author of a paper that they had nothing to do with…paper mills often use artificial intelligence to alter the text they lift from other papers…”

“The papers that Dr. Amaral and his colleagues could study came to light only because of the work of independent sleuths. To estimate how many paper mill papers have yet to be exposed, Dr. Amaral’s team created a statistical model that accurately predicted the rate at which suspicious papers surfaced. They estimate that the number of paper mill products may be 100 times greater than the ones they have identified…”

“In their new study, they calculated that the number of suspicious new papers appearing each year was doubling every 1.5 years. That’s far faster than the increase of scientific papers overall, which is doubling every 15 years.”

““We need to stop making it profitable to game the system.”

My take: This problem has preceded the widespread use of AI, although Al makes it harder to detect. Unfortunately, fake scientific reporting appears to be worsening.

Related article: Jessica Steier NY Times 8/19/25: The Playbook Used to ‘Prove’ Vaccines Cause Autism This article details very specifically how David Geier (now appointed by RFK Jr to evaluate vaccines and autism) and his father have produced multiple flawed studies regarding vaccine safety. This commentary takes a particularly deep dive into one of his articles on the preservative thimerosol. She shows that the authors likely used p-hacking to identify “atypical autism” since there was not a significant association with autism, compared different time cohorts (the control group was from a period with different diagnostic criteria/lower rates of autism), did not include confounders, and supported their arguments with “personal citing.”

Some excerpts:

There have been some 70 studies since Mr. Wakefield’s looking for any link between vaccines and autism. Of these, 26 have linked vaccines to autism in some way, and 43 found no connection between vaccines and autism.

A whopping two-thirds of studies that claimed to have found a link were written by  David and Mark Geier. These studies have been heavily criticized for using deceptive research techniques and flawed data.

Among the eight other studies that found a link, four were retracted for data manipulation, flawed methods or undisclosed conflicts of interest. Most of the authors have been involved in anti-vaccination campaigns and have had other papers retracted.

One such study that Mr. Kennedy referred to in his Senate confirmation hearing was published in a WordPress blog disguised as a journal and was funded by an anti-vaccine organization, among other problems.

Fortunately, independent scientists have conducted more than 40 high-quality studies since 1998 involving over 5.6 million people across seven countries. All found no connection between vaccines and autism. These studies were rigorously designed, were reviewed by independent peers and do not contain telltale signs of data manipulation, as the Geier studies do.

Related blog posts:

Part of the Tower of London complex

Are We Giving the Right Advice on Sunlight?

I was recently listening to a radio program (On Point) about the beneficial effects of sunlight.

The program notes that the potential beneficial effects of sunlight are much greater than the risks. Increased sunlight has been associated with lower rates of death, as well as lower rates of cardiovascular disease and autoimmune conditions like multiple sclerosis, type 1 diabetes, and Crohn’s disease.

When dermatologists recommend avoiding sunlight, they may be focused on the risks but not the benefits (though this varies among individuals). In addition, despite the more than 5-fold rise of melanoma diagnosis (especially in wealthy communities), there has not been a change in the rate of deaths due to melanoma. Skin cancers associated with sun exposure are mainly basal cell tumors and squamous cell tumors. These non-melanoma skin cancers have excellent survival rates.

Here is a link: The Healing Power of Sunlight (48 minutes) The most important part of this is in the middle, starting around 20 minutes.

My take: It’s a good idea to avoid sunburns but getting sunshine is good for health.

Related article:

  • Environ Epidemiol 2025. 9(3):e401. doi: 10.1097/EE9.0000000000000401. The association between time spent outdoors during daylight and mortality among participants of the Adventist Health Study 2 Cohort. Conclusion: “Moderate time outdoors in daylight during warmer months could be associated with lower risks of all-cause, CVD, and noncancer non-CVD mortality”

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River Cherwell in Oxford, UK
Oxford Botanic Garden

‘What Happens When the Doctors Can’t Trust the Government?’

Danielle Ofri, NY Times 7/28/25: Doctors Have Lost Their Mount Olympus of Medicine

This entire essay is worth reading but may be behind a paywall.

An excerpt:

For most of my colleagues and me, the C.D.C. and the N.I.H. were the medical Mount Olympus, the towering pillars of medical authority. Contrary to right-wing portrayals, these were not dictatorial authorities. These were earned authorities, comprising our best, brightest and most dedicated peers. The formidable talents of these doctors and scientists would have commanded enviable salaries had they taken jobs in industry, but they chose the public sector instead — something that we clinicians were forever grateful for… 

While there are some doctors who viewed our public health institutions with disdain — some of them now are running these very organizations — most practicing physicians relied heavily on them to deliver the best care possible to their patients, despite occasional quibbles. What a relief, I always felt, that there were people organizing the things I can’t do — testing new treatments, conducting population studies, keeping tabs on worldwide diseases, issuing guidelines and more.

But now that support is a shell of what it once was. I can no longer automatically rely on these institutions because their scientific North Star, even if imperfect at times, has been replaced by one that seems nakedly political. Remaining staffs are no doubt working valiantly to do their jobs, but they are hobbled by loss of colleaguesresources and reliable leadership. So when I hear that the C.D.C. has changed a vaccine recommendation, I now question whether that’s a recommendation I can trust. When the F.D.A. commissioner says he wants to change how the agency approves or rejects new treatments, I no longer feel sure that science is driving those decisions. It’s hard to convey how profoundly grieved my colleagues and I feel…

Robert F. Kennedy Jr.’s view seems to be that we doctors are shills for corporate interests and government bureaucrats, and that torching our vaunted institutions is the prescription to fix us. Mr. Kennedy’s ire seems oddly directed. I, too, am disgusted by the role of money in health care, but I see it more as a result of the system we’ve set up, rather than the people who labor within it…

Notably missing from Mr. Kennedy’s Make America Healthy Again agenda is any suggestion that we provide universal health care, as most other developed countries do. There is no push to expand Medicare and Medicaid, which help some of our sickest patients. There is no focus on expanding access to early childhood education and supplemental nutrition programs, which offer steep health benefits…[There] is a barely concealed antipathy toward the people who are the engine of these institutions — doctors, scientists, policy wonks…

Cuts to infectious-disease surveillance means that outbreaks will almost certainly creep up more stealthily on our patients. Cuts to the National Center for Chronic Disease Prevention and Health Promotion means fewer resources for prevention of cancer, heart disease and diabetes — some of the leading causes of death. Cuts to the N.I.H and the F.D.A. could drastically reduce the development and approval of new medical treatments. Add in cuts to injury-prevention research and patient safety programs, and it’s a prescription to make America sick again.

Every time you go to your doctor or get treated by a nurse, there’s a chorus of researchers, public health workers, policy experts, epidemiologists and advisory panels arrayed behind them, aided by laboratories, databases, websites, early-detection systems and clinical guidelines. Our current government seems determined to wrench this away, handicapping your health care team’s ability to care for you.

My take (borrowed in part from author): Our health care system needs to improve costs, accessibility, and outcomes. Yet, the changes to our healthcare and research under this administration are making matters worse. “So many of our resources are now gone, and those that remain no longer feel trustworthy. Americans’ health will decline at the hands of our federal government. And there’s no vaccine for that.”

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Giant Lily Pads in Oxford, UK

Health Disinformation Risks from AI Chatbots

MD Modi et al. Annals of Internal Medicine; 2025. https://doi.org/10.7326/ANNALS-24-0393. Abstract: Assessing the System-Instruction Vulnerabilities of Large Language Models to Malicious Conversion Into Health Disinformation Chatbots

Methods: This study assessed the effectiveness of safeguards in foundational LLMs against malicious instruction into health disinformation chatbots. Five foundational LLMs—OpenAI’s GPT-4o, Google’s Gemini 1.5 Pro, Anthropic’s Claude 3.5 Sonnet, Meta’s Llama 3.2-90B Vision, and xAI’s Grok Beta—were evaluated via their application programming interfaces (APIs). Each API received system-level instructions to produce incorrect responses to health queries, delivered in a formal, authoritative, convincing, and scientific tone.

Key findings:

  • Of the 100 health queries posed across the 5 customized LLM API chatbots, 88 (88%) responses were health disinformation

Examples of how AI systems can be used to create disinformation:

My take: This study shows how easy it is to get AI systems to provide misleading information in a convincing fashion. It might be interesting to include one of these systems to provide answers for the board game Balderdash.

Related blog posts: