Big Pharma > Johnson and Johnson aware of probable Tylenol link to neurodevelopmental issues 10 years ago

 

Tylenol Maker Said in Internal Emails Evidence of Link to Autism ‘Starting to Feel Heavy’

The emails came to light in litigation against Johnson & Johnson.

Tylenol lines the shelves of a store in Brandon, Miss., on Sept. 24, 2025. John Fredricks/The Epoch Times

Zachary Stieber

Senior Reporter

9/30/2025|Updated: 9/30/2025

The manufacturer of Tylenol was keeping tabs on research into the drug and neurodevelopmental issues such as autism, and concluded in 2018 that evidence of a link between them was becoming significant, according to newly disclosed documents.

In a Feb. 8, 2018, email obtained by The Epoch Times, Rachel Weinstein, director of epidemiology at Johnson & Johnson subsidiary Janssen, wrote, “The weight of evidence is starting to feel heavy to me.”

Weinstein was emailing Jesse Berlin, Johnson & Johnson’s global head of epidemiology, about a review that concluded that nine studies suggested that use of acetaminophen—the active ingredient in Tylenol—by pregnant women was linked to autism and other neurodevelopmental issues in the women’s children.

Weinstein said that Janssen had been discussing with a neurologist about how acetaminophen could be beneficial.

“But now we’ve added the studies in prenatal exposure and neurodev [sic] outcome,” she said.

Berlin wrote that he read the review and that “there appears to be some specificity of the association.” While he took issue with how some papers did not analyze other drugs, “at least one study looked separately at specific indications and the association didn’t go away,” he said.

Johnson & Johnson was the maker of Tylenol for years. In 2023, a newly created company called Kenvue took over the Tylenol brand and other consumer brands.

“These documents show we were doing exactly the right thing,” a spokesperson for Kenvue told The Epoch Times in an email. “We have continuously evaluated the science, and there is no credible evidence that taking acetaminophen causes autism.”

‘Difficult Options’

Dr. Jørn Olsen of Aarhus University in Denmark and other researchers in 2014 released an observational study that determined maternal acetaminophen use during pregnancy was linked to a higher risk of attention-deficit/hyperactivity disorder-like behavioral problems or hyperkinetic disorders in their children.

Weinstein, in an email, told Olsen that the study had strengths but wondered whether the researchers had tried assessing any association between other drugs pregnant women take, such as aspirin, and the disorders. Olsen, in a brief reply, said the researchers planned to look at those drugs in future studies.

Weinstein forwarded the email to the company’s consumer medical safety division.

“Recall that we have ruled out the possibility of conducting a database study of our own because other existing databases would be underpowered to detect the same effect that the Danish study found, due to the lack of a large enough database,” she wrote in her email.

She asked whether the question for the company was whether there was a willingness to support Olsen “up to a reasonable amount with the provision that the investigator has final say on publication but the sponsor can review and comment on the manuscript prior to publication.”

Weinstein told Berlin that there were several options, including funding Olsen. They could also try to replicate Olsen’s study, conducted in Denmark, with Norwegian data on prescriptions and diagnoses, and by including other drugs.

“The outcome of such a study is unknown. We could end up confirming the Danish findings, for example,” she said.

She later drafted a note to Olsen that initially said Johnson & Johnson would be happy to work with him on additional research. Berlin in response proposed revisions. But Weinstein then told Berlin she was having second thoughts on engaging Olsen.

“Do we really need to stick our neck out and make this offer? Would we be surprised if the new analyses confirmed or did not confirm the existing studies?” she asked.

Berlin responded: “I’m trying to think through what we would do based on what we learn. I don’t have a huge problem abandoning this, if that’s where we end up after talking.”

Weinstein, who is now retired, could not be reached for comment. Berlin, now a professor at Rutgers University, did not respond to a request for comment.

Internal slides from around the time of the emails, obtained by The Epoch Times, stated that the company declined to pursue a collaboration with Danish researchers in part because executives were unsure about “the value to pregnant consumers,” who might be presented with “difficult options” such as “don’t use anything if you have a fever.”

Lawyer: ‘Irresponsible’

The emails came to light in lawsuits brought by women who say they should have been warned by Johnson & Johnson and retailers about the risks of neurodevelopmental problems associated with acetaminophen products.

The women have pointed to papers such as a 2020 prospective study in Canada that found an increased risk of ADHD among children born to women who used acetaminophen while pregnant.

“Drugmakers have a legal and ethical obligation to continually investigate the safety of their products. Yet despite recognizing the heavy weight of the scientific evidence years ago, Kenvue scientists made a deliberate decision not to ’stick our necks’ out to commission further research,” Ashley Keller, senior partner at law firm Keller Postman, which is representing the women in multiple cases, told The Epoch Times via email.

“The reason for that irresponsible choice is obvious. The company didn’t study the question for fear they would not like the answer. But pregnant moms deserve answers, and protecting a multi-billion dollar drug franchise is no excuse for ostrich-like corporate misbehavior.”

The emails were first reported by the Daily Caller and drew the attention of the White House and the Department of Health and Human Services.

Government officials recently warned the public that Tylenol use during pregnancy may be associated with autism in children born to the mothers.

‘We Have Been Looking at It’

Weinstein said in a 2023 deposition that it would be unethical to run a randomized, controlled trial seeking to figure out whether there was a link between in utero acetaminophen exposure and neurodevelopmental problems. It would be good to do “more tightly controlled” observational studies, or research utilizing sources such as medical claims databases, she said.

Weinstein also said that Johnson & Johnson had been tracking literature on the topic for nearly a decade, including epidemiological, safety, and preclinical studies.

She said that the company has “essentially done a systematic review,” or an analysis of strong studies on the matter.

She said the company would be publishing the review but did not know when.

Internal slides from 2018, obtained by The Epoch Times, described the results of a company analysis of 16 studies regarding prenatal exposure to acetaminophen and neurodevelopmental disorders.

The slides stated that individual observational studies “show a somewhat consistent association of increased occurrence of neurodevelopmental outcomes with prenatal exposure,” with strengths including some studies being prospective. Limitations included researchers measuring children at different ages, such as 18 months and seven years.

A 2022 internal Kenvue slide deck stated that 12 studies featuring clinically diagnosed endpoints were analyzed. The studies were “too limited in methodological or analytical design to draw conclusions regarding a causal relationship between prenatal acetaminophen use and adverse neurodevelopmental outcomes in children,” and therefore, if acetaminophen is used as directed, it is safe to use during pregnancy, the slide deck stated.

A review coauthored by Kenvue scientists and funded by Kenvue was published by Critical Reviews in Toxicology in February.

The authors of the review said that they reviewed preclinical studies and determined that the data “demonstrates no consistent evidence of adverse effects following developmental exposure to acetaminophen at therapeutic and/or non-systemically toxic doses on the structure and function of the nervous system, including neuroanatomical, neurotransmission, and behavioral endpoints.”

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Bayer Stock Sinks 12% After Court Rules Weed Killer It Bought from Monsanto Caused Cancer

Why Bayer, primarily a pharmaceutical company, bought Monsanto, an agrochemical company known for making Roundup and Agent Orange, is beyond my imagination. Agent Orange produced dreadful famine in Viet Nam and many horrible diseases in the people and in the soldiers who encountered it. 

Bayer's website makes this astonishing claim:

We exist to help people thrive - Advancing health and nutrition is what we do best and care about most.

© Global Look Press / Sven Hoppe

Bayer shares plunged more than 12 percent after a second US jury ruled that glyphosate-based Roundup weed killer causes cancer. It was a huge blow to the German pharmaceutical giant which bought US agrochemical firm Monsanto.

The stock drop during Wednesday morning trading on the Frankfurt exchange wiped out almost $8 billion from Bayer's market value.

The unanimous decision by a jury in San Francisco federal court followed another ruling made in August in California. Back then, the biotechnology corporation was ordered to pay $289 million in compensatory and punitive damages over the case of a school groundskeeper, Dewayne Johnson, whose cancer was allegedly caused due to years of using glyphosate-based Roundup.

The latest verdict was not a finding of Bayer’s liability for the cancer of plaintiff Edwin Hardeman. The trial is expected to proceed to the next phase, beginning on Wednesday, with the jury to determine the liability and damages in the case.

Bayer, which specializes in producing pharmaceuticals, consumer healthcare products, agricultural chemicals and biotechnology products, inherited the legal battles with its $63 billion acquisition of Monsanto, the US' leading producer of genetically engineered crops. Bayer may potentially face thousands of similar lawsuits in the US alone.

However, the German company has denied claims that glyphosate or Roundup causes cancer and said it was disappointed with the jury’s decision.

“We are confident the evidence in phase two will show that Monsanto’s conduct has been appropriate and the company should not be liable for Mr. Hardeman’s cancer,” Bayer said in a statement.

Good luck with that! I think you paid a fortune for a big liability.

Canada Sees No Cancer Risk from Monsanto’s Roundup Weed Killer

Nothing I could say here that would not put me at risk of being sued

Oh, Canada

© Reuters / Benoit Tessier

Canadian farmers will continue using glyphosate after Health Canada concluded that the active ingredient in Monsanto’s Roundup weed killer poses no human risks.

The federal agency dismissed eight notices of objection and assertions made in the so-called Monsanto Papers in 2017.

“After a thorough scientific review, we have concluded that the concerns raised by the objectors could not be scientifically supported when considering the entire body of relevant data. The objections raised did not create doubt or concern regarding the scientific basis for the 2017 re-evaluation decision for glyphosate,” Health Canada said in a press release.

The 2017 re-evaluation determined that glyphosate is not genotoxic and is unlikely to pose a human cancer risk. It also determined that dietary exposure associated with the use of glyphosate is not expected to pose a risk of concern to human health. When used according to revised label directions, glyphosate products are not expected to pose risks of concern to the environment, according to the study.

Health Canada said it has selected a group of 20 of its own scientists who were not involved in the 2017 decision to evaluate the eight objections and the concerns raised publicly around glyphosate. The agency said its scientists “left no stone unturned in conducting” the review.

The agency noted that it “had access to numerous individual studies and raw scientific data during its assessment of glyphosate, including additional cancer and genotoxicity studies.” It added that it will “continue to monitor for new information related to glyphosate, including regulatory actions from other governments, and will take appropriate action if risks of concern to human health or the environment are identified.”

Glyphosate is the active ingredient in Monsanto’s Roundup, which is the most popular weed killer in the US. German chemicals and pharmaceuticals giant Bayer, which bought Monsanto last year, disclosed earlier that lawsuits from 9,300 plaintiffs were pending at the end of October. The lawsuits alleged that the company’s recently acquired weed-killing product caused cancer.

The surge in lawsuits followed the $289-million California court verdict when Monsanto was ordered to pay damages to a man who alleged its glyphosate-based weed killers, including Roundup, caused his cancer.

Bayer rejected all the accusations, claiming there are hundreds of scientific studies and regulatory authorities that show glyphosate, the compound contained in the weed killers, is safe to use.

And how many of those studies were funded by Monsanto? I'm guessing, all of them!

Monsanto Sued Again by Brazilian Soybean Farmers over GMO Seed

Monsanto - Agricultural Mafia?

Workers harvest soy in a farm in Brazil © Paulo Whitaker / Reuters

Growers in Brazil’s largest soybean producing state Mato Grosso have asked a court to cancel Monsanto’s Intacta GMO seed patent. They claim irregularities, including the company’s alleged failure to prove it brings de facto technological innovation.

The Mato Grosso branch of Aprosoja, the association representing the growers, has filed a lawsuit in a federal court in Brasilia. The growers claim Monsanto’s Intacta RR2 PRO patent “does not fully reveal the invention so as to allow, at the end of the exclusivity period, for any person to freely have access to it.”

That requirement “avoids that a company controls a technology for an undetermined period of time,” Aprosoja said, adding Intacta’s patent protection extends through October 2022.

It cited data from consultancy Agroconsult, saying that about 53 percent of Brazil’s soy area was planted with Intacta technology in the 2016/17 crop cycle. Around 40 percent of the crop is grown with Monsanto’s Roundup Ready seed technology (Intacta’s predecessor), and only seven percent is non-GM.

Brazilian farmers have been continually urging the replacement of genetically modified soybeans with non-GM seeds. Recently they asked Monsanto and other producers of pest-resistant corn seeds to reimburse them for money spent on additional pesticides when the bugs killed the crops instead of dying.

Several years ago five million Brazilian soybean farmers sued Monsanto, claiming the genetic-engineering company was collecting royalties on crops it unfairly claims as its own. In 2012, the Brazilian court ruled in favor of the Brazilian farmers, saying Monsanto owes them at least $2 billion since 2004.

After the legal disputes, Monsanto stopped collecting royalties linked to its first-generation Roundup Ready technology, and some farmers agreed to get a discount rate to use Intacta seeds.

Biotech crops are genetically engineered to resist pests or disease, tolerate drought or withstand the spraying of weedkillers like glyphosate, the active ingredient in Monsanto’s Roundup herbicide.

In the US, the herbicide has been considered safe since 2013, when Monsanto received approval from the US Environmental Protection Agency (EPA) for increased tolerance levels for glyphosate. 

EPA needs to be gutted and run by people not in the industries it pretends to regulate.

However recently, the World Health Organization ruled it’s a carcinogen which along with other Monsanto chemicals could cause Parkinson's disease, Alzheimer’s disease, autism, and cancer.

Possible Game-Changer for Autistic Kids May Never Happen

‘Game-changer for autism’: 100-year-old drug reverses symptoms, study finds

The drug Suramin could be used to alleviate the symptoms of autism © Veri Sanovri / Global Look Press

A drug discovered more than 100 years ago may hold the key to combating autism symptoms, according to a study.

Researcher Dr Robert Naviaux of the San Diego School of Medicine gave suramin, a drug first developed in 1916, to 10 autistic boys between the ages of five and 14, and noted transformative results.

"After the single dose, it was almost like a roadblock had been released," he said. “If the future studies show that there’s continued health benefits, this could be a game-changer for families with autism.”

The study, which has been published in the Annals of Clinical and Translational Neurology, saw five of the participants receive suramin, while the remainder were given placebos. Included in the group were four non-verbal children – two six year olds and two 14 year olds. 

“The six year old and the 14 year old who received suramin said the first sentences of their lives about one week after the single suramin infusion,” Naviaux told the UC San Diego Health website. “This did not happen in any of the children given the placebo.”

The Centers for Disease Control and Prevention estimates that about 1 in 68 children are affected by autism – which is more than four times more common among boys. The causes of autism, however, are not yet fully understood.

Research has shown that cells harden their membranes in response to attacks from viruses or pollutants. The reaction, known as ‘cellular danger response’ (CDR), is a common defense mechanism that allows cells to wait for danger to pass. Autism is thought to develop during early childhood when cells can become ‘stuck’ in this mode.

Dr Naviaux believes that suramin can ‘un-stick’ the cells by inhibiting the signal they release when they sense danger, which can help normalize the response.

One parent, whose son had not spoken a full sentence in more than a decade, said: “Within an hour after the infusion, he started to make more eye contact with the doctor and nurses in the room. There was a new calmness at times, but also more emotion at other times.” 

“He started to show an interest in playing hide-and-seek with his 16-year-old brother. He started practicing making new sounds around the house. He started seeking out his dad more.”

Suramin was originally developed as a cure for sleeping sickness, a parasitic disease spread by the tsetse fly in sub-Saharan Africa.

First tested on mice in 2013, this is the first time suramin has been administered to children.

For Naviaux, the challenge now is to widen his research to a bigger sample testing size. “This work is new and this type of clinical trial is expensive,” he said. “We did not have enough funding to do a larger study. And even with the funding we were able to raise, we had to go $500,000 in debt to complete the trial.”

Time for a change

The problem here is obvious. 100 year old drugs cannot be patented and therefore can be made very inexpensively. The profits for big pharma will not likely ever exceed the extraordinary costs of trials. This is the the huge elephant in the small room of health care. 

The way the system works is that there are no advances in medication that don't cost exorbitant amounts of money. Cheap and easy solutions to many diseases go by the boards because no-one is willing to fund the trials needed for their acceptance.

Governments, all of which are fighting rapidly increasing costs of drugs and health care, have to make some hard decisions. They either have to find new and cheaper and quicker ways to do clinical trials, or they have to fund those trials for medications that will reduce costs for both drugs and healthcare if those trials are successful.

Governments can benefit from funding such trials as this by lowering the costs of drugs which will make them more affordable for patients meaning more patients who need the drugs will get the drugs and consequently be in better health and require less in terms of medical care and, in many cases, social care. Improvement in quality of life can be immeasurable. 

It seems like a no-brainer to me. But I think the trick would be to create a resource pool funded by most countries in the world, perhaps through the WHO. It would not be onerous if many countries contributed and it would be far more beneficial than some international programs currently running.

Of course, big pharma would be mad as hell, but I'm OK with that!