If you’re following the news lately, you know the Trump Administration recently announced an alarming increase in the number of cases of autism and they say Tylenol may be to blame for the increase. Doctors and medical societies say acetaminophen, the active ingredient in Tylenol, remains the best option for treating fever and pain during pregnancy. What’s a pregnant woman to do if she has a high fever or severe pain?

Brianna Abbot and Andrea Petersen, writing for The Wall Street Journal, tell us studies looking at a link between acetaminophen and autism are inconclusive; some show a link between its use during pregnancy and autism risk, while others don’t.

• A 2019 study published in JAMA Psychiatry found that higher concentrations of acetaminophen in umbilical cord blood samples taken at birthwere linked to greater risk of autism and attention-deficit hyperactivity disorder.
• Another in JAMA in 2024 of nearly 2.5 million children in Sweden found no increased risk in children when mothers took acetaminophen during their pregnancy, compared with their siblings who weren’t exposed to the medication in the womb.

Part of the challenge with such studies is wading through the myriad other confounding factors when analyzing the results. Women take Tylenol during pregnancy because they are running a fever or have pain or an infection. Those problems could be the root of a potential autism risk, rather than the medication used to alleviate them, researchers said.

“All of those factors in fact pose a somewhat higher risk to the developing fetus than does the Tylenol itself,” said Helen Tager-Flusberg, director of the Center for Autism Research Excellence at Boston University. “For studies that control for that, we see a far reduced or lowered impact of the Tylenol.”

Tylenol is one of the few medications recommended by doctors for pain or fever during pregnancy. Most other pain relievers including ibuprofen, often sold as Advil, or naproxen aren’t generally recommended because they can harm the fetus.

What is the risk of leaving pain and fever untreated during pregnancy?

Untreated fever, especially in the first trimester, and pain in pregnancy can raise the risk for miscarriage and birth defects, according to the Society for Maternal-Fetal Medicine. “It’s really important to treat the fever,” said Dr. Judette Louis, chair of the Society for Maternal-Fetal Medicine’s Publications Committee. “If they don’t take Tylenol and their fever persists, they might go into preterm labor.”

Preterm birth and other potential consequences of untreated pain and fever are themselves risk factors for autism and other neurodevelopmental disorders. They likely pose a greater risk than the medication itself, doctors said.

Untreated pain can also contribute to maternal depression, anxiety and high blood pressure. The pregnant woman’s overall well-being is important, too, said Dr. Allison Bryant, a high-risk obstetrician at Massachusetts General Hospital. “We certainly don’t want individuals who are pregnant to suffer only because they are pregnant if we think there is a safe alternative,” Bryant said.

What do doctors recommend that pregnant women do?

Pregnant women who have a fever or pain should consult their doctor, advises Bryant. Pain can be an indicator that there is an underlying problem that needs to be addressed, she notes. A temperature over 100.4 degrees is considered a fever.

Both the Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists continue to recommend acetaminophen use for pain and fever when necessary in pregnancy. Pregnant women should “feel confident using acetaminophen, if it’s otherwise indicated, and after consultation with their providers,” said Bryant, who is also a committee chair of the American College of Obstetricians and Gynecologists. Women should limit its use as much as possible, doctors said, taking it only when needed and then stopping when their fever or pain is resolved.

Since Tylenol has been available on the market since 1960, does Tylenol usage represent the only reason for the rise in autism?

Autism’s causes are complex and not fully understood, but most of it comes down to a person’s genetics, researchers say. The rise in autism rates in the U.S. is largely due to broadening the diagnostic criteria, heightened awareness and increased requirements for documentation needed to access supportive services, they said.

Environmental risks in utero can also contribute, with studies showing links between increased autism risk in children and older parental age, preterm birth, maternal obesity and some infections during pregnancy.

The bottom line for me as a physician: avoid any drugs, especially Tylenol, during pregnancy, unless your doctor feels the benefits outweigh the risks.

The Trump administration is cracking down on pharmaceutical advertising and it’s about time. You don’t have to spend much time watching television to realize that drug ads dominate TV advertising. It wasn’t always this way.

When I started my medical practice in 1984, the pharmaceutical companies spent most of their advertising budgets hiring sales representatives who spent their time promoting their drugs directly to doctors. I usually saw two or three different drug company sales reps in my office each week. They gave me their pitch to use their drugs and provided me with samples to give out to the patients. I got direct information on the new drugs and the patients got free samples. It was a useful system and the television was free from drug ads.

But somewhere along the way the system changed. Previously prohibited television advertising was allowed and drug companies shifted their focus from direct sales promotions to doctors to direct sales to consumers. I noticed the change quickly when I stopped seeing sales reps in my office and free samples for my patients. Moreover, I started seeing television ads that put rose-colored glasses on the new drugs they were selling.

As a doctor, I can understand most of the sales promotions on television, but woe to anyone who hasn’t been to medical school!  The average person can’t possibly understand the nature of the drugs they’re selling nor the risks involved with their treatment. I’ve often told my wife you could use the same ad for every different drug on the market because they all have one thing in common – the people in the ads are happy, active members of society that bear no resemblance to those who are actually being treated for the disease!

I’m convinced the intent of the ads is to inform doctors, not patients, since they have largely disbanded their sales force that used to promoted their drugs direct to doctors.

In response to this situation, President Trump recently signed an executive order calling for stepped-up federal enforcement of rules for pharmaceutical ads. Liz Essley Whyte, Natalie Andrews, and Alyssa Lukpat, reporting for The Wall Street Journal, tell us what happened:

In conjunction with the action, the Food and Drug Administration said it is sending thousands of enforcement letters to drugmakers related to misleading ads. In addition, the Department of Health and Human Services is planning to close what the administration sees as a loophole allowing certain broadcast ads to give abbreviated descriptions of drug side effects. The FDA’s guidance they seek to amend, first proposed in 1997, allowed drugmakers to list only major side effects in TV advertising while posting fuller information in another location, such as online. That guidance fueled a boom in TV drug ads, according to drug ad experts.

The enforcement effort targets drugmaker TV ads as well as paid social-media influencer posts and telehealth advertising, administration officials said.

 The FDA shared a sample of a letter it would send, saying it was directing a company to remove noncompliant advertising and bring promotional communications into compliance. “FDA is concerned patients are not seeing a fair balance of the information regarding a drug product,” the agency’s sample letter said. The crackdown is a major step up from recent enforcement levels, administration officials said: The agency in 2023 sent one warning letter and none in 2024.

“We’re going to be tough on this,” FDA Commissioner Marty Makary said in an interview on a Wall Street Journal podcast. “Drug companies spend 20% to 25% of their budgets on marketing and ads. I’d like them to spend that money on lowering drug prices for everyday Americans.”

Major drugmakers take pains to follow FDA rules on advertising, with many submitting TV ads to the agency before they run to get advice, drug ad experts said. But in recent years digital ads for weight loss offerings of telehealth firms and medical spas have proliferated online, many without any discussion of side effects.

Pharmaceutical companies spent more than $10 billion on prescription drug ads last year, with the top 10 drug brands accounting for $3.3 billion, according to an analysis by MediaRadar, which analyzes ad data. That includes advertising on television, streaming networks, websites and other mediums.

Health Secretary Robert F. Kennedy Jr. has long criticized direct-to-consumer drug advertising, saying it inflates U.S. drug spending and makes media beholden to drugmakers. “Pharmaceutical ads hooked this country on prescription drugs,” he said in a statement Tuesday. “We will shut down that pipeline of deception.”

If you’re following the news lately, you know that Democrats, and a few Republicans, are up in arms about eliminating vaccine mandates. Some fear they won’t be able to get vaccines when they need them. But no one is being denied vaccines. The government is simply allowing people to make their own decision without mandates that force everyone to comply. What’s the science behind this new approach?

Dr. Marty Makary, the new Commissioner of the Food and Drug Administration, explains in an Op-ed published in The Wall Street Journal. Here’s his explanation:

“The Food and Drug Administration last week approved Covid-19 vaccines for adults over 65 and for people 6 months and older who have one or more risk factors that put them at high risk of severe Covid. This regulatory framework brings the U.S. in line with peer nations—in France such vaccines are recommended for people over 80 and in the U.K, for people over 75. Although the world has moved on to a risk-tiered approach, some in the American medical establishment are maintaining their blind faith in a strategy of boosters for all in perpetuity. They should consider these six points:

First, the FDA can approve products only if we believe there is substantial certainty that the benefits outweigh the risks. Currently, we don’t have that confidence for, say, a seventh Covid shot for healthy 12-year-old girl who recently recovered from Covid.

Second, if your doctor deems that you need a Covid vaccine, you can still get one. The FDA can’t regulate the practice of medicine. The FDA grants marketing authorizations, but doctors are able to prescribe drugs off label to people at low risk. In a few states, pharmacists may require a prescription.

Third, as part of our approval the FDA is demanding that all companies run a clinical study assessing whether the new Covid shots improve outcomes in healthy subjects. These post-market randomized trials will use a true placebo control (salt water) so we will learn the side-effect profile. The FDA has asked, and the companies have agreed, to monitor if the spike protein—the molecule the vaccine creates in the body—persists after vaccination. Several studies have shown the persistence of spike protein, which some believe contributes to adverse events. The FDA’s mandate is to compel companies to generate evidence to answer questions Americans have.

Fourth, some argue that Covid shots are needed for those who live with or take care of immunocompromised or elderly people. But no company has ever submitted data to the FDA to prove that Covid shots, which do not halt transmission, prevent caregivers from infecting vulnerable people. Accordingly, the FDA has never allowed companies to advertise that claim.

Fifth, some claim that Covid shots mean kids are less likely to miss school and adults more likely to attend work. No vaccine manufacturer has ever submitted data to the FDA to validate these claims either. Similarly, some argue that repeat doses prevent long Covid. Again, the FDA has no data to support this claim and has never allowed manufacturers to make it. As part of our new framework, we have asked sponsors to measure long Covid symptoms.

Sixth, the FDA’s new framework essentially ends mandates. Mandates were contentious, and ultimately a policy error, pushing hundreds of thousands of people out of work, without clear evidence of helping the public. Since the FDA isn’t approving a vaccine for the healthy school-age and working population, college and school mandates will be legally impossible. Accordingly, the FDA is revoking the emergency-use authorization for Covid vaccines. The emergency is over. The FDA will now return to an evidence-based standard.

Ultimately, no one knows how many shots a healthy person should get in his natural life, or if a healthy person who already had Covid benefits from a seasonal dose. The FDA’s new framework preserves vaccines for those who might most plausibly benefit, while generating evidence for most Americans, who are voting with their feet (or their upper arms) against an eternal annual booster campaign.”