FDA takes action to make a treatment available for autism symptoms

Trust in Pharma, FDA, and Government

• Many commenters are deeply skeptical of the manufacturer due to past criminal cases over off‑label promotion, safety reporting, and kickbacks.
• Several see the approval as fitting a broader pattern of regulatory capture and “infomercial”‑style government, with comparisons to COVID vaccine politics and prior FDA controversies.
• Others push back, noting the company’s long track record of important drugs and that it is not a new or Trump‑created entity.

What the Drug Actually Targets

• Multiple readers stress the approval is for cerebral folate deficiency (CFD) with “autistic features,” not autism in general.
• The title and framing are criticized as misleading marketing: the text barely mentions autism compared to CFD.
• There is concern this will be oversold as “a cure for autism” and start a revolving door of weakly supported autism “fixes.”

Evidence Quality and Study Design

• Critics say the evidence base is thin: small double‑blind RCTs (~40–50 participants, ~12 weeks), plus case reports and mechanistic data.
• Some argue that such small samples are reasonable for large, obvious effects (parachute/insulin analogies), but others reply autism outcomes are subtle, behavioral, and noisy, so underpowered studies and publication bias are serious issues.
• Several request or provide links to systematic reviews and trials, noting that even those papers usually call for larger studies before wide rollout.

Autism Epidemiology and Framing

• One faction rejects “it’s just diagnostic drift,” arguing that severe/profound cases have clearly become more common in schools and require specialized classrooms.
• Others ask for more rigorous data on whether severe cases are actually increasing, and highlight how changing diagnostic criteria complicate trend analysis.
• Some criticize the very idea of a single “cause” or “cure” for autism as conceptually wrong and harmful to autistic people.

Politics, Fascism, and Institutional Trust

• The thread veers heavily into U.S. politics: arguments about fascism, Trump, protests, and weaponization of the DOJ overshadow the medical topic.
• There is visible polarization: some see the administration as fascist and dangerous; others vehemently dispute that description.
• A few participants worry openly about autistic people being “listed” for future abuses and advise avoiding disclosure; others counter that this is exaggerated and note similar data collection in other countries.

Anecdotes, Alternatives, and Risks

• Parents’ anecdotal reports (e.g., on Reddit) describe improvements with leucovorin; skeptics note that anecdote exists for almost any intervention.
• Some mention other supplements or lifestyle changes (folate variants, omega‑3s, CBD, diet, sensory strategies) as potentially helpful.
• One commenter warns that large new demand could create shortages of leucovorin for chemotherapy patients, with life‑threatening consequences.