Reply to Leucovorin now approved by FDA--will providers prescribe to ASD kids?

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Reply to "Leucovorin now approved by FDA--will providers prescribe to ASD kids?"

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[quote=Anonymous][quote=Anonymous]Calling for a large, pre-registered trial doesn’t mean the existing studies were poorly designed—it’s simply the natural next step in clinical research. Smaller RCTs are meant to generate evidence and refine endpoints before investing in large-scale trials. In fact, the reason researchers want a bigger study is precisely because the preliminary data have shown consistent, promising signals in autistic children with folate pathway issues. Large, multi-site trials take years to fund, design, and complete. Families facing daily challenges don’t always have the luxury of waiting a decade for “perfect” evidence. Medicine often advances by balancing what we know now with what we’re still learning. Leucovorin is not an experimental compound with unknown safety—it’s an FDA-approved medication long used in pediatrics for other indications, with a well-understood safety profile.

The existing smaller RCTs and open-label studies show improvements in communication and behavior in subgroups of autistic children with folate metabolism abnormalities. While these results need confirmation, they’re strong enough to suggest that some children may benefit. For a low-risk, potentially high-reward treatment, it’s reasonable for clinicians and parents—especially when biomarkers indicate susceptibility—to consider a trial of therapy now, rather than withholding it until a large trial eventually happens.[/quote]

No, all RCTs should be designed with scientific integrity no matter how small. Also the FRAT test is not considered medically necessary by many insurance companies so the jury is out on that as well. [/quote]

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