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][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous]Can you really buy this over the counter?  Can someone post a link if so?  I know that folinic acid is not the same as methlyfolate.

As a mom of an ASD boy with limited verbal communication,  I am interested in trying this.  I am obviously concerned about side effects but I think people are not taking into consideration how debilitating it is to struggle with communication.  I watch my child struggle all day every day. So from my perspective this drug or vitamin is worth a try.  I think everyone understands it is not a cure... but it seems it has helped some kids.  
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Its a prescription drug. The question is, is a study with 40 kids a good enough reason to give your kid a prescription drug (already approved, this is an off-label use), that may or may not work, or would you prefer to wait a couple of years for actual studies that would figure out a) how do we figure out [i]which [/i]kids it works for, b) what are the correct doses and dispensing instructions and c) what other factors (like speech therapy) should be provided in conjunction for the drug treatment to be most effective?

Wait, that's a false choice because DOGE and RFK Jr. fired everyone at the NIH and cancelled all the university research funding for autism. [/quote]

What do you think the answer would be if you asked parents if they wanted to try a drug now with a long safety history, that might not help, but that might lead to small-to-moderate improvements to verbal communication? Or if they'd rather wait for a couple years as their kid falls further and further behind?

They'd jump toward it.

I really don't think a lot of the posters here understand what kids and parents are already going through with medications. Even established drugs used for on-label indications have low efficacy and significant negative effects.

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DP. How does this excuse Trump and RFK Jr engaging in this pump & dump scheme? When they are literally the two people in the entire country who could make the research happen so parents would have more to go on than “maybe this will help”.

And you are wholly ignorant if you think there is somehow no possibility of negative side effects. because of course the trials have *not been done* to find out. [/quote]

Who said there was no possibility of negative side effects?  Of course there is. But there's a 70-year history demonstrating safety, and recent studies involving kids with ASD demonstrating minimal side effects occurring at similar rates as placebo. Compare that to risperidone and Abilify. Or even methylphenidate and guanfacine.

Would I like to see more studies? Of course. Do I want to wait until they're done before looking at whether it plausibly might work for my son? Definitely not.

More studies are unlikely to answer the main question of efficacy: whether it will help my son. We've tried several on-label and commonly prescribed off-label medications over the years. Most didn't work. Many led to significantly worse behaviors. The available data on Leucovorin tells a pretty convincing story that it's better than most of what we've been through. It probably won't work, but it probably won't do as much harm as the other things we've tried.

You could probably call me a combination of selfish and impatient. But I've got a kid currently taking much more dangerous drugs with lackluster results at a critical time in his development. Waiting 2 or 3 years for a well-organized RCT would come too late. The odds of success are small, I know, but even small successes could be life-changing. Weighed against the outcome of doing nothing differently with my child, it seems like a very easy choice from a risk-benefit perspective.[/quote]

I’m just going to quote the actual autism experts again:

“With this in mind,” the group added, “we do not support any recommendation from the HHS or FDA regarding increased use of folinic acid. Instead, we call for a well-designed, large scale clinical trial of leucovorin (folinic acid) with all of the rigor needed (biomarkers, proper endpoints) and, most importantly, a pre-registered analysis plan.””[/quote]

There have been trials- one in the US, and a larger one in India. They both had pre-registered analysis plans.

Yes, they were small, but I don't understand the reluctance to accept them given the efficacy and dosing of ASD medications is always highly variable. If two double-blind RCTs found significant improvement to, say, cancer patients, using an established, safe drug, doctors would be jumping to try it before the label is updated. They're not going to tell patients to just hope that they're still alive in a few years after larger trials occur.

I could understand wanting more data before updating the label. I was initially under the impression that positive FRATs were not particularly common with ASD, making me think the applicable patient population is small. But, given the promising data and, especially, the safety record, I don't understand the opposition to off-label use.

The group you cited didn't just state caution and tell people to talk to their doctors. They're  specifically advocating against off-label use. This isn't a situation where doctors always advise against off-label use. Most, if not all, doctors who treat ASD through medications end up commonly prescribing drugs off label.

That opposition to off-label use is what makes me think they probably need to update the label.

Some of this feels similar to the people that cautioned against the covid vaccines, suggesting that they were being rushed out before the election. People need to ignore Trump and RFK here. We all know they're idiots.[/quote]

So you know better than all the autism experts. Got it! [/quote]
DP. So anyone who thinks leucovorin is bad is an autism expert but anyone with similar credentials is a quack? Got it.

Not sure who you think did the studies. Dr. Frye which someone has accused of being a quack is a medical doctor who has worked with autistic kids for decades but RFK jr is unqualified to be head of HHS because he’s not a doctor (kinda like the last one wasn’t but whatever). Also experts for any number of conditions frequently do not agree. It’s just giving mental illness on your part at this point. [/quote]

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