The Big Autism Announcement Is A Big Pile of You-Know-What
The current administration has made its Big Autism Announcement, and it is big, all right: a big, easily predicted steaming pile of bullshit.
Amid a flurry of false claims from the current administration, the FDA is promoting leucovorin for autism, even though it once put a leucovorin/autism trial on hold.
The current administration has made its Big Autism Announcement, and it is big, all right: a big, easily predicted steaming pile of bullshit. One of their biggest claims has led us to a clinical trial that – wait for it – was terminated because of investigator noncompliance. More on that below.
Meanwhile, all the greatest hits this crowd favors were front and center at the big announcement, as we all expected, and as we covered here at TPGA:
Talking about autism and autistic people like they need to be prevented, while making outdated, long-debunked claims? Check. [My “favorite” of these is their argument that there are no autistic people over age 50.]
Blaming pregnant people for using recommended agents (acetaminophen, in this case) during pregnancy, and using autism as a bogeyman to scare them away from accessing the only recommended pain reliever available to them in pregnancy? Check. Those of us who bear children already know the evergreen experience of being blamed for everything while deprived of what we need for health and comfort during pregnancy. The blame that the health secretary, the occasional occupant of the White House, and their cronies slathered on today while cautioning people from seeking the only recommended pain relief available during pregnancy is not new to us. After all, we are merely descendants of Bettelheim’s “refrigerator mothers,” and if we’re not appliances somehow ruining our children after their births, then we’re gestation machines doing everything wrong before they are born.
Blaming vaccines, another factor shown over and over, during decades, not to be a factor? A factor that was implicated based on a retracted study of 12 people that has since been deemed fraudulent? Of course, they brought up vaccines. Check.
Suggesting a “treatment” based on the flimsiest possible data that, if it were effective in any way, would only be so in a very small proportion of autistic people, but gosh if it isn’t one that cronies want to sell to parents of autistic children? It is! Check.
About that leucovorin, a drug that mitigates deficits in mitochondrial function, specifically those induced by cancer treatments: There’s been a valiant effort among some selfless folks to lead parents of autistic children to believe mitochondrial dysfunction underlies their child’s autism and that a supplement form of this drug could “treat” their child. Robert F Kennedy the Lesser is clearly enamored with this idea, probably because he thinks it will finally prove he’s right after so many years of being so, so wrong. Two of his key advisors have a book to sell predicated on mitochondrial dysfunction as the root of, well, everything. Naturally, other people have related things to sell. At the center of this industry is a company called NeuroNeeds™ where Richard Frye and his pal Dan Rossignol offer these supplements for sale branded as SpectrumNeeds™.
A handful of trials have assessed the effects of leucovorin in autistic children. All of the trials are quite small with substantial limitations, and some are thus necessarily published in, let’s say, concerning journals. But one really stands out: It was published in a respected journal, Molecular Psychiatry, in 2016 as an e-publication and in 2018 formally. It is described as a randomized, controlled trial. Frye is the first author. The trial was sited at the University of Arkansas, and the principal investigator listed at the ClinicalTrials.gov site where researchers input their trial plans is Richard Frye.
And although the results of this trial were published in Molecular Autism, the ClinicalTrials.gov site shows that it was put on hold by the FDA, in 2017, and terminated for investigator noncompliance*. It was planned as a dual Phase 1 and then Phase 2 trial, begun in May 2012. According to a note at the Clinical Trials site:
The study sponsor (UAMS [University of Arkansas for Medical Sciences]) was unable to completely monitor the study or resolve outstanding queries. The study data cannot be fully validated by the sponsor. The study was placed on Full Clinical Hold by the FDA and terminated by the sponsor as a result of investigator non-compliance.
Other notes say, “No data because no patients were analyzed,” and “0 participants.”
Yet, on the same page, there’s a link to that published study in Molecular Psychiatry as associated with this specific clinical trial. That link goes to the publication’s listing in the PubMed database, where you can see for yourself the clickable ClinicalTrials.gov link that goes straight to the terminated trial page. The details of that publication of a “randomized, double-blind, placebo-controlled trial” match up entirely with those listed on the ClinicalTrials.gov page, including the dosage used, the time frame for dosing, the scales used to measure autism-related traits, and the affiliation of the first author.
It’s curious, certainly, that the trial was placed on hold by the FDA, especially given that as part of today’s announcement, the FDA has “taken action” to make leucovorin “available for autism symptoms.” In a truly garbled press release, they claim the action has been taken specifically to treat people with cerebral folate deficiency, which is not, I must emphasize, autism.
The agency’s commissioner, Marty Makary, makes clear what they really mean. In the press release, he says that there’s been a “tragic four-fold increase” in autism over two decades and claims that they are using “gold standard science” to take this action. I wonder if that 2016/2018 study based on a trial the agency put on hold is part of that gold standard science.
GSK is updating the label for leucovorin to encompass “cerebral folate deficiency,” a condition that the company describes as a “rare disorder,” which it is. The FDA says that its decision is about cerebral folate deficiency but then includes two quotes from FDA officials about autism, which as they repeatedly highlight, is not especially rare. There were no quotes from them about cerebral folate deficiency. Clearly, they are using a rare, real medical condition as cover to push leucovorin as an autism “treatment.” Cui buono, one wonders.
In that garbled release, the agency’s director of drug evaluation and research, George Tidmarsh, implies that autism is a “chronic disease” and that the agency remains “committed to finding and treating the root causes of autism.” And that gets at the root of what they are really after: making bank on the promise of erasing autistic people from existence.
*Major hat tip to Canadian developmental pediatrician Dr. Melanie Penner for alerting us to the termination of the leucovorin trial.
News you can use
Check out these neuro-affirming educational, animation videos that celebrate autistic experiences and perspective and were made by an all-autistic team of writers. One video is called “Discovering You’re Autistic” and the other is called “Lightbulb Moments: Being Autistic.” There are also accompanying blog posts, a pair for each video – one each addressing autistic viewers and non-autistic professionals. A very lovely antidote to, well, ^^^^ all that up there.
New York state congressman Mike Lawler introduced a resolution that designated September 19 as Black Autism Acceptance and Awareness Day. The resolution was inspired by one of the “People you need to know” we’ve highlighted in this newsletter before, Ayanna Sanaa Davis, who goes by Phenomenally Autistic on social media.
When autistic peers participate with each other in peer-support programs, the result is generally beneficial, according to a systematic review published in the journal Autism.
Reddit gets a lot of negative press, but I like it as a source of information and community. A study published this summer in Autism Research involved an analysis of almost three-quarters of a million Reddit posts about autism to sort out the key topics that emerged. The authors found a few key themes that won’t surprise most autistic people, including challenges with social interactions and talking about stimming. Also perhaps not surprising, Reddit emerges as a useful platform for autistic people.
Perhaps we can get out ahead of this now that they’re trying to scare pregnant people about acetaminophen: When controlling for confounders, researchers publishing in PLOS Medicine find no link between opioid use in pregnancy and having an autistic child.
Here is an entire ding-dang special issue of the Augmentative and Alternative Communication Journal on the Power of Collaboration. It features articles from the May 2024 Future of AAC Research Summit.
The current administration may think that there aren’t any autistic people over age 50, but everyone else knows that’s not true. They know that in Brazil, for example, where they’re working on validating a couple of autism screening tools for adults, including one specifically designed for women.
People you should know
Lucy Bronze (Lucia Roberta Tough Bronze) is an autistic English football player (that’s soccer to you USians). She talked in a recent interview about being diagnosed, noting as many do that when it happened, “so many things started to make sense.” Turns out, her hyperfocus, she says, is football: “I'm passionate, I'm obsessed. That's my autism.”
Give a listen to this Access All podcast episode and meet The Bengsons (Abigail and Shaun) an autistic folk-rock duo. Shaun also is navigating something I can relate to, which is (genetic) hearing loss.
Bits and bobs
Back next week! This wasn’t a very “bit” or “bob” kind of week.
Here’s to hyperfocus and other things we love.
Got something autism-related to share with us? Send it along to editorial@thinkingautism.com.
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About the Author
Dr. Emily Willingham is a 2022 MIT Knight Science Project Fellow, and the author of several books, including the upcoming If Your Adolescent Has Autism: An Essential Resource for Parents from Oxford University Press, and has served as a regular contributor to Scientific American and other national publications.