9 ms·
FDA takes action to make a treatment available for autism symptoms
- p_ing 1y agoZero references to medical studies.
- cpncrunch 1y agohttps://pmc.ncbi.nlm.nih.gov/articles/PMC7477301/ https://pmc.ncbi.nlm.nih.gov/articles/PMC7477301/ https://pubmed.ncbi.nlm.nih.gov/34834493/ https://pubmed.ncbi.nlm.nih.gov/34834493/
- tencentshill 1y agoThe cure is a simple pill, provided by a company with a long history of corruption, prosecuted for "promotion of drugs for unapproved uses, failure to report safety data and kickbacks to physicians in the United States". A company that operates like that sees opportunity in this US administration. https://en.wikipedia.org/wiki/GSK_plc https://en.wikipedia.org/wiki/GSK_plc
- vkou 1y agoIf the adults ever return to the room, what exactly should be done by everyone responsible, to make nobody else even dream of doing this?
- lupusreal 1y ago[flagged]
- throwup238 1y agoA never ending vigilance against corruption. That’s the only real solution — any other system or set of rules can be undone.
- ryandrake 1y agoIf the electorate wants a circus, they'll elect clowns. There's really not much non-clowns can do about it if elections are to be maintained and fair.
- mpalmer 1y agoUntil elections become something else entirely, and then the non-clowns can do even less.
- atmavatar 1y agoPractically speaking, no amount of punishment for fascists will ensure that another set of fascists won't rise up again in the future. There's far too much to gain by taking over political power for any deterrent to work effectively. The best solution is to improve education to help people see through the bullshit that got us here. In particular, teach people that campaigning through memes, emotional appeals, and demonization of minority groups are big neon signs that the campaigning group does not have your best interests in mind.
- cbeach 1y agoWhich "fascists" are we talking about, here? Be careful around powerful words with meaning (see https://en.wikipedia.org/wiki/Fascism https://en.wikipedia.org/wiki/Fascism ). If we casually use these words to refer to people we simply disagree with - one day, when actual fascists start rising, we'll have taken all the meaning out of the language we rely on to identify them.
- morkalork 1y agoApparently Dr Oz stands to profit from one of those approvals..
- vasusen 1y agoLike many things where what constitutes base data changes and hence graphs change pretty radically, this can be cleanly explained by diagnostic drift. Here's a detailed breakdown: https://www.cremieux.xyz/p/how-to-end-the-autism-epidemic https://www.cremieux.xyz/p/how-to-end-the-autism-epidemic
- Glyptodon 1y agoThis isn't a serious article. While it's true that parents and schools have a weird relationship with ASD, with some parents doing anything to refuse the label no matter how apt, at other times with officials and parents going out of their way to do things like label kids with symptoms of severe trauma as having ASD, along with a long tail of higher SES parents who see claiming various special ed needs (not just ASD ones) as a way to get more resources for their children, particularly in states where they can get additional vouchers or payments with a label, these things don't really change a ground truth: severe autism is not easy to hide or easy to fake, and cases are increasing. IMO diagnostic drift is maybe a fine thing hem and haw about when it comes to mild cases. But it's basically a form a bike shedding because the severe cases are so incontrovertible and so much more common than they used to be. You can't claim that kids with severe cases are okay and just out to get money because they're so obviously and clearly not well. And schools have gone from maybe having none to a couple per grade to needing whole classrooms or even schools to safely handle high severity autism over the last 50 years. You could maybe instead claim that "when achieving any semblance of normalcy is impossible, society shouldn't spend so much effort," but that is usually not a well-received message because it sounds like the forced institutionalization or incarceration of the mentally ill or locking them in bedrooms to be forgotten. Similarly, there are some situations where the repercussions of severe early childhood trauma get diagnosed as autism, but these are also situations where you'd still have a massive service need, so there's no cost reduction to be had, just a proportionally small chunk of misdiagnosis.
- amanaplanacanal 1y agoAre severe cases more common? Do you have some papers exploring this?
- Glyptodon 1y agoI'm surprised they didn't just "partner" with General Mills or some such to turn this into an advertisement for folate fortification in sugary breakfast cereals. For those replying: I did not mean this would seriously work, but that it would be par for this administration to basically bring cereal ads from Saturday morning cartoons into the CDC.
- incomingpain 1y agoThe typical folate in food or even the pregnant women folic acid supplement is good at preventing these birth defects; but for someone with NDD it would actually not help and depending on dose block up the pathways for it to heal.
- trehalose 1y agoLeucovorin works (at least for some cases of CFD) because it bypasses a folate transport protein that can be nonfunctional and fail to transport ordinary folic acid into the brain. I guess that doesn't necessarily mean they couldn't do what you're suggesting though.
- reenorap 1y agoThe dose in the pill is very high, it's not something you can just let everyone take.
- lupusreal 1y agoThis pill is an obvious scam. Legos are the treatment. Give autistic kids more legos.
- bobmcnamara 1y agoNo Lego. Only TRAAAAIIIINS
- lupusreal 1y agoLego trains, of course.
- dsr_ 1y agoThis is absolute corruption of the FDA's mission to accurately label and appropriately market drugs. The evidence is from a study with N=40. Not 40,000. 40.
- metalcrow 1y agoCan you link to the study? The release implies there are multiple but doesn't link to any
- bunderbunder 1y agoHere's a PubMed search. https://pubmed.ncbi.nlm.nih.gov/?term=leucovorin+cerebral+folate+deficiency https://pubmed.ncbi.nlm.nih.gov/?term=leucovorin+cerebral+fo... It's worth noting that, in the absence of pre-registration, one should should assume that the body of literature (and any systematic review or meta-analysis that relies on it) could be significantly influenced by the file drawer effect. Anyway, I looked at a recent systematic review from those search results (https://pmc.ncbi.nlm.nih.gov/articles/PMC8622150/ https://pmc.ncbi.nlm.nih.gov/articles/PMC8622150/), and it found exactly one double-blind RCT (https://pmc.ncbi.nlm.nih.gov/articles/PMC5794882/ https://pmc.ncbi.nlm.nih.gov/articles/PMC5794882/) that seemed to support what the FDA is saying here. It had a fairly short duration (12 weeks) and a small cohort (48). I'm not medical expert but I do read medical literature as an amateur, and I'm pretty sure this is nowhere close to the standard of evidence for establishing safety and efficacy that the FDA used to demand. It feels like we may be reverting all the way back to the evidentiary standards that allowed crap like thalidomide onto the market.
- metalcrow 1y agoThank you! That's useful. And yeah i agree, this and the aducanumab scandal make it seem the FDA is going away from "too strict" back to "too loose".
- OkayPhysicist 1y agoSample size doesn't tell you everything about a study. You don't need to throw 40,000 people out of an airplane to determine it's safer with a parachute.
- leakycap 1y ago> "The U.S. Food and Drug Administration today initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD) ... Individuals with cerebral folate deficiency have been observed to have developmental delays with autistic features (e.g., challenges with social communication, sensory processing, and repetitive behaviors), seizures, and problems with movement and coordination." The wording, my emphasis added, certainly suggests this is a new med for CFD even though the title mentions Autism symptoms, not CFD Search for the word autism in the release and tell me if you think this treats what they suggest in the title. It would be every other word if they believed it.
- chris_wot 1y ago[flagged]
- newobj 1y agoI know they're not serious because they didn't recommend methylcobalamin. Kinda funny how in all this chatter no one is talking about MTHFR etc.
- malfist 1y agoPerhaps because B12 supplementation isn't a cure for autism?
- josefritzishere 1y agoThis is the Amway administration. I am running out of words.
- silverquiet 1y agoThat was the last Trump administration, where the Secretary of Ed was married to the CEO of Amway. The current one is the former CEO of World Wrestling Entertainment, so I'd say it's more the Pro Wrestling administration.
- deleted 1y ago[deleted]
- kg 1y agoI worry that once it turns out this doesn't actually work, there's going to be a revolving door of the 'next new Autism fix' and gradually kids with autism are going to be loaded up with more and more drugs of unproven effectiveness based on low-quality studies.
- calebm 1y agoSo good to see them actually addressing the Autism epidemic. Some people are still parroting the "Autism has not increased - it's just a difference in diagnostic criteria" BS.
- deleted 1y ago[deleted]
- pklausler 1y agoThe next pandemic is going to be an epic disaster.
- reenorap 1y ago[flagged]
- whoknowsidont 1y ago[flagged]
- reenorap 1y agoNeither. Autism is something that is very important to me, mainly because of my friend's experience with his two autistic children and the fact my child was mistakenly diagnosed as autistic. It turns out he was suffering from generalized anxiety disorder and misdiagnosed by a couple of psychiatrists. It's sad that you think that people with opinions other than yourself is engaging in "flagrant rage baiting."
- whoknowsidont 1y agoTry being honest, you only have one life on this Earth.
- notacoward 1y agoCan you support your claim about tens of thousands of Canadian children on a waiting list for treatment? I'd love to see what kind of sources you (or your hypothetical friend) are using. Here's what the Canadian government has to say. https://www.canada.ca/en/public-health/services/diseases/autism-spectrum-disorder-asd/supports-services.html https://www.canada.ca/en/public-health/services/diseases/aut... "Health Canada has not approved any medications for the treatment of autism." Are you yourself confusing diagnoses for autism with diagnoses and (this time real) treatments for other conditions? That's the most charitable explanation I can think of, and it still seems a bit hypocritical. Maybe that's where the "flagrant rage bait" accusations come from.
- amanaplanacanal 1y agoFocusing on chronic diseases and healthier food is definitely a good thing! Throwing out science and touting bullshit theories is a bad thing.
- Mizza 1y agoWashPo article on this was interesting: https://www.washingtonpost.com/health/2025/09/22/leucovorin-autism-treatment-rfk/ https://www.washingtonpost.com/health/2025/09/22/leucovorin-... Seems like it works only for a very specific type of childhood autism, but if my child had this I would be kicking down doors to get it. The article has some good insight into how honest researchers feel about their work being trumpeted by the scientifically illiterate carnival barkers in charge of things.
- perching_aix 1y agoUnpaywalled: https://archive.md/FpHmz https://archive.md/FpHmz
- ornornor 1y agoCan you imagine if it had been a vaccine rather than a pill?
- xkcd-sucks 1y agoBased on the manufacturer's history, nothing good: https://en.wikipedia.org/wiki/GSK_plc#2010_Pandemrix_connected_with_narcolepsy https://en.wikipedia.org/wiki/GSK_plc#2010_Pandemrix_connect...
- jmclnx 1y agoDoes anyone with knowledge still pays attention to .gov sites ? Seems they are all filling up at different rates with pseudo science, or in other cases, removing science facts.
- jkaplowitz 1y ago.gov is available to nonfederal US governmental entities as well. Those .gov sites run by states and cities which still believe in science are still worth paying attention to. Also even federal .gov sites remain reliable for certain topics like giving current statutory or regulatory text.
- nineplay 1y agoLooking for The Cause of autism and The Cure for autism is exactly as absurd as looking for The Cause of cancer and The Cure for cancer. I think most people understand that there are many causes of cancer and many treatments that cover a range of different use cases. The whole concept of a cause and cure is really damaging to the autistic community and just flying in the face of any sort of intelligent diagnosis and treatment.
- estimator7292 1y agoI'm about 98% certain this is simply a ploy to put autistic people on a list for future abuses. In today's political climate, nobody should be revealing their autism status to anyone remotely connected to any level of government. Nor should one trust any sort of medical advice or reporting from same. Our government is explicitly targeting minorities of all sorts for abuse and persecution. Now is, unfortunately, the time to hide and weather the storm. That or flee to another country with a functioning society. Please protect your autistic children and friends. Times are real, real bad for them right now.
- incomingpain 1y ago>I'm about 98% certain this is simply a ploy to put autistic people on a list for future abuses. I'm a foreigner, not even in the USA. Your politics are melting down but I feel like the FDA isn't tracking or seeking to harm you. >In today's political climate, nobody should be revealing their autism status to anyone remotely connected to any level of government. Nor should one trust any sort of medical advice or reporting from same. Our government is explicitly targeting minorities of all sorts for abuse and persecution. Pretty strong argument against socialized medicine. Here in Canada the government actively tracks each of these. For example to get the covid shot, they wanted to know about my autism, non-binary/trans etc. They werent just asking everyone this, I didnt bring it up because why would it matter? I was in their system. I also happen to know this data is being transferred out of country to CDSI; ASN 23498. >Now is, unfortunately, the time to hide and weather the storm. That or flee to another country with a functioning society. I dont think you need to flee the usa. Canada has drastically reduced migration, you dont want to come here. Europe maybe?
- heffer 1y ago> I also happen to know this data is being transferred out of country to CDSI; ASN 23498 CDSI is Cogeco Data Services, Inc., a Canadian ISP, which later became Aptum, which in turn was acquired by Beanfield, also a Canadian ISP (the founder Dan Armstrong is actually well known in the internet community in Canada) that operates AS23498. So I don't see how this would prove your data is leaving the country.
- tonmoy 1y ago> The FDA has conducted a systematic analysis of literature published between 2009-2024, including published case reports with patient-level information, as well as mechanistic data, and has determined that the information supports a finding that leucovorin calcium can help individuals suffering from CFD. I would have liked to see some citations. I’m mostly curious about the sample sizes
- sys32768 1y agoFor the non-partisans who actually care more about autism in children than they do throwing ideological jabs, there are numerous interesting anecdotal reports from parents of children who have been trying leucovorin in the past year or so: https://www.reddit.com/r/Autism_Parenting/search/?q=leucovorin https://www.reddit.com/r/Autism_Parenting/search/?q=leucovor... My hope is that this does lead to breakthroughs in understanding the mechanism for some types of autism, and perhaps even a "miracle" drug akin to how stimulants can radically transform the brains of many with ADHD.
- yibg 1y agoYou can have anecdotal about anything in any direction. Not a great way to come to a scientific conclusion.
- reissbaker 1y agoCan you also have clinical trials performed under the Biden administration that "significantly improve communication with medium-to-large effect sizes and have a positive effect on core ASD symptoms and associated behaviors" about anything in any direction? https://pubmed.ncbi.nlm.nih.gov/34834493/ https://pubmed.ncbi.nlm.nih.gov/34834493/ https://pmc.ncbi.nlm.nih.gov/articles/PMC7477301/ https://pmc.ncbi.nlm.nih.gov/articles/PMC7477301/
- yibg 1y agoI'm not sure how that's related. Some research is flawed and statistics provide misleading or incorrect data so we just... don't care about data?
- reissbaker 1y agoI am pointing out that your claim that this is just anecdotal is incorrect. There is published research showing medium-to-large effect sizes for exactly this treatment. Why do you think people were trying it on Reddit in the first place?
- codedokode 1y agoWikipedia says that autism is caused by DNA errors, so the only perfect cure would be, as with many other incurable diseases, DNA editing? I wonder if we come into the future where parents will be able to buy DNA fragments for example, for certain eye color or size, or for thin hands and legs, and collect future child's DNA from pieces. Or DNA will be considered non-copyrighted and owner of elf ears won't be able to sell his unique feature? Seems not fair to me. Also whether there will be pirate sites with DNA.
- joquarky 1y agoCheck out Gattaca (1997)
- deleted 1y ago[deleted]
- notacoward 1y agoIt's also worth noting that leucovorin is an important drug for counteracting the effects of methotrexate (chemotherapy drug), and this thinly veiled attempt to drive profit for Dr. Oz's company could create a shortage. This kind of thing has happened before, eg. with some of the bogus COVID treatments. In other words, this is not just unhelpful. It might actually kill people.
- joquarky 1y agoWhen are they going to find a reliable treatment for sociopathy? That seems to be doing far more damage to the world right now.
- amai 1y agoI wonder about the following: Leucovorin is most often given in the form of Leucovorin calcium. That is interesting, because calcium is needed to regulate the release of dopamine in the brain. And this might also help with autism: https://news.ki.se/new-study-links-dopamine-to-autism-symptoms https://news.ki.se/new-study-links-dopamine-to-autism-sympto... However there is also Leucovorin sodium. Are there any studies that compare Leucovorin calcium vs. Leucovorin sodium in autism? Maybe it is in fact the calcium that helps with autism and not the Leucovorin part?