Episode #25 Deep Dive – Paging Reality: Unpacking the Week’s Wildest Health Claims
A deep dive into this week's episode of Paging America
Trump says Tylenol causes autism, promotes bogus cure
On Monday, surrounded by RFK Jr., Dr. Oz, and others, Trump held an almost unbelievable press conference where he started by saying there is a connection between the use of Tylenol (acetaminophen) and autism. Trump couldn’t even pronounce the name of the medication (vide of that is HERE.)
Trump also seems totally freaked out by vaccine shots, saying that they’re pumping “too much liquid” into little babies (video of that is HERE.)
Trump also announced that leucovorin has been determined to be a treatment for autism despite a lack of evidence that it’s actually a treatment:
Top medical organizations and lawmakers have widely panned Health and Human Services Secretary Robert F. Kennedy Jr. for promoting the theory as he looks to fulfill his promise to find the root causes of autism.
The White House recommended the use of the drug leucovorin, a form of folate, as a potential autism treatment. Medicaid will cover the drug for autism and the National Institutes of Health will launch trials to research the impact of leucovorin. NIH will invest $50 million in autism research.
You can watch Committee Board Chair Dr. Kristin Lyerly responding to Trump’s announcement during an appearance on Scripps News Morning Rush HERE.
RELATED from The Wall Street Journal: Kenvue Braces for Wave of New Lawsuits Over Tylenol’s Potential Link to Autism
Meanwhile, both the European Medicines Agency and the U.K.’s Medicines and Healthcare Products Regulatory Agency said that taking acetaminophen during pregnancy remains safe and no evidence shows it causes autism in children.
STAT has a full rundown of the stunning press conference.
The FDA announced that it would change leucovorin’s label to reflect potential benefits in reducing autism symptoms.
Via NBC News (emphasis added):
Many researchers questioned whether the approval was premature, given that only a handful of small trials — mostly conducted outside the U.S. — have pointed to leucovorin being effective in children with autism.
Several experts told NBC News that the FDA’s approval could give false hope to families, since not all children with autism may qualify for a prescription and, even if they do, the likelihood of seeing results is uncertain. [...]
“It’s not like scientists have just been staring at their belly buttons for 20 years, not looking at autism treatments. They have, but the standards have been very high to get it approved,” said Alycia Halladay, chief science officer at the Autism Science Foundation. Her organization, which funds evidence-based autism research, does not recommend leucovorin as a treatment and says more studies are needed.
Leucovorin “doesn’t have the criteria to meet FDA approval, but yet this administration is just doing it anyway. So I wouldn’t exactly call this a win,” Halladay said.
FDA announces review of mifepristone
Also this week, RFK Jr. announced a re-review of mifepristone, one of the two medications used in medication abortions. Mifepristone has been FDA-approved for 25 years as a safe and effective drug used to manage abortions as well as miscarriage care.
Kennedy and FDA Commissioner Marty Makary sent a letter to 22 Republican attorneys general who had requested the FDA review mifepristone’s safety, and said the FDA would conduct “its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug.”
It’s worth noting that we just marked the 25th anniversary of the FDA approving mifepristone, and that they conducted a review of mifepristone less than three years ago. RFK Jr.’s decision to re-review the drug for supposed safety concerns is based on a sham “study” that The Atlantic calls a junk science paper from a Washington, D.C.–based think tank focused on “pushing back against the extreme progressive agenda while building a consensus for conservatives.”
Abortion rights advocates are worried the move could lead to significant restrictions on the most common abortion method nationwide.
Day Two of the ACIP meeting
On Thursday and Friday last week, Kennedy’s newly-stocked ACIP met for the first time and the public meeting was nothing short of a colossal clown show. They met to consider their recommendations for COVID-19 vaccines, MMRV vaccine, the childhood schedule, and the hepatitis B vaccine.
The first day they voted one way on two vaccines. The next day, they changed their minds:
In a surprise move on Friday morning, a panel of vaccine advisors to the federal government backed off from a proposed change to the vaccine schedule that would have scrapped the current recommendation that all children receive the hepatitis B shot at birth.
It also reversed a vote it took yesterday on coverage for a shot known as the https://riverside.fm/studio/miles-bakers-studio-Us8vT?t=dcce12d63c25725ad24fMMRV — measles, mumps, rubella and chickenpox (or varicella). Yesterday, the panel said the Vaccines for Children program could cover the combined shot if parents want it — Friday they voted that it shouldn’t. The MMRV shot is no longer recommended to be given, and it will not be paid for by government insurance.
Starting the meeting on Day Two, Kulldorff acknowledged their inexperience – what many would call being unqualified – saying “We are rookies,” on the opening of the second day.
More:
As he opened it Friday morning, Kulldorff explained that the members’ lack of experience led them to need to redo a vote from the previous day because the wording had been confusing.
The outcome of that re-do was to change the insurance coverage of the MMRV vaccine for low-income children. On Thursday, the panel ended with a split vote: MMRV shots were not recommended, but they would be paid for by the government. Friday’s re-do vote made it all align — not recommended, not allowed to be paid for.
Then came hepatitis B. Although some on the committee seemed enthusiastic about pushing the first dose recommendation for hepatitis B from birth to 1 month of age, after some discussion, there was a revolt against tackling the issue at all…The committee voted 11 to 1 to table action on the birth dose of hepatitis B vaccine, with Kulldorff as the lone dissent.
Via NBC News (emphasis added):
At the meeting on Thursday, CDC staffers summarized the results of 17 studies, which found that the hepatitis B vaccine is overwhelmingly safe and has helped to virtually eliminate hepatitis B infections among newborns. The agency also noted that many pregnant women aren’t screened for hepatitis B in the U.S., making it hard to rely on testing to decide which children to vaccinate. According to the CDC, 12-16% of pregnant women in the U.S. are never tested for hepatitis B during pregnancy — and even if they are, some cases can be missed. [...]
Two committee members, [Dr. Robert] Malone and Vicky Pebsworth — both of whom have a history of sharing misinformation about vaccines — said the CDC presentations omitted a 2012 report from the Institute of Medicine. The report said it couldn’t determine whether hepatitis B vaccines were associated with brain inflammation because no studies had properly looked at that research question.
“The absence of data that statistically proves lack of safety does not mean that the product is safe,” Malone said on Friday morning.
Pebsworth also raised concerns about CDC data showing irritability or fussiness in some infants who received the hepatitis B vaccine.
“These are not trivial reactions,” Pebsworth said.
They then took on COVID-19 vaccines:
The [ACIP panel] voted unanimously on Friday to further limit access to Covid vaccines, recommending that adults 65 and older receive the shots only after discussing the potential benefits and risks with a health care provider.
The panel also said that everyone from 6 months to 64 years old could get the vaccine after consulting with a provider. But it was unclear whether that contradicted the Food and Drug Administration’s authorization of the shots only for adults over 65 and younger people with certain health conditions.
Fierce Pharma has a full run-down of the two-day debacle HERE.
Links for a deeper dive on Episode #25
Dr. Annie Andrews’ campaign website is HERE.
Dr. Annie Andrews is on X, Instagram, YouTube, Threads, TikTok, and BlueSky
Roll Call: Trump, officials link Tylenol to autism as medical community balks
Video of Trump trying to pronounce “acetaminophen” is HERE.
Video of Trump talking about pumping babies with too much liquid is HERE.
Committee Board Chair Dr. Kristin Lyerly’s response to Trump’s Tylenol announcement during an appearance on Scripps News Morning Rush is HERE.
The Wall Street Journal: Kenvue Braces for Wave of New Lawsuits Over Tylenol’s Potential Link to Autism
European Medicines Agency: Use of paracetamol during pregnancy unchanged in the EU
UK Medicines and Healthcare products Regulatory Agency: MHRA confirms taking paracetamol during pregnancy remains safe and there is no evidence it causes autism in children
STAT: Trump, questioning vaccine safety, pushes major changes to how kids get shots
The New York Times: What Is Leucovorin, the Medicine Being Approved for Autism Treatment?
NBC News: Is leucovorin an effective treatment for autism? Here’s what research shows
NPR Shots: ‘We are rookies’: Day 2 of CDC vaccine meeting opens with a reversal and a surprise
NBC News: In an unorthodox move, CDC vaccine advisers table a vote on hepatitis B
The New York Times: Kennedy’s Vaccine Panel Votes to Limit Access to Covid Shots
FIERCE Pharma: RFK Jr.’s revamped ACIP contradicts itself as confusion, tension reign over MMRV vaccine vote
STAT: Medicaid cuts will hurt all American children — not just those publicly insured
MedPage Today: Doctors Report Confusion, Hurdles to Getting COVID-19 Shots for Kids