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Anonymous wrote:I would love to hear other people experiences with Leucovorin

Because we’re doing science by anecdote now I guess.

Ever hear of case studies?

Case studies are not the kind of evidence the FDA generally uses to determine the safety and efficacy of a medication.

It's been used for 70 years. We already know it's safe.

They put cocaine in cough syrup for 70 yesrs

Do you not realize that Leucovorin continues to be used?

… in cancer. Stop lying.

You compared the safety record of Leucovorin to the safety record cocaine. I'm not the one being disingenuous. You can argue we don't know how effective it is for ASD, but we already know it's safe.

That wasn’t me but for the record cocaine actually does have medical uses right now (as a topical anesthesia).

So do you think that makes the safety record of cocaine similar to the safety record of Leucovorin? Otherwise, what's your point?

The point is that saying a drug is safe and effective for one indication says literally nothing at all about whether it is safe and effective for a wholly different indication. If you cannot grasp this entirely basic and fundamental point then you probably shouldn’t be in this discussion.

Again, we don't know it is effective, but we do know it is safe. Safe doesn't necessarily mean there's absolutely no possibility of risk. We approve drugs and other substances while there is still small potential for risks, with after-market monitoring being used to catch exceptional events. Leucovorin has the substantial benefit over new drugs in that we already have a long safety history with the drug.

It's ridiculous to suggest it isn't safe. Particularly given the risks of other things that are available and generally accepted as safe- including prescription medications, supplements, and food ingredients.

No we do NOT KNOW if it is safe in the population it is now being touted for. It has side effects that absolutely could be more unsafe for kids with autism vs adults with cancer. Specifically, seizures and aggression are known side effects and these are bigger concerns for autism. AND there is also research connecting too much prenatal folate to autism.

We.do.not.know.

On that basis, almost nothing is "safe" for use in kids with autism because these kids often aren't part of clinical trial populations. Since you're saying a safety record for the general population shouldn't be used to infer safety in a subpopulation.

Again, you're being disingenuous. This is done all the time. Heck, look how often drugs get prescribed off-label because of how hard it is to run trials (particularly in kids).

Frankly, off-label use here would seem to be the right move, too. But clearly something has happened over the last 10 years, and particularly with this drug, to make some doctors lose their ability to weigh risks and potential benefits rationally and in the best interest of their patients. Why are they treating it so differently than something like guanfacine, another drug with a long safety history that is frequently prescribed for young kids with autism presenting with aggressive or self-injurious behaviors, despite those being off-label.

This is a drug being specific touted FOR kids with autism. So yes, it is relevant to ask how it specifically affects them. And of course the whole point is that this went far beyond off-label use, departing from how additional uses are added and making overblown claims not supported by the evidence.

More importantly while it may be an understandable stance for an individual parent with their doctor to use a med off-label under the background of slow or nonexistent goldstar research - that is far different from the people *literally in charge of the research* upending it. Trump and RFK jr are pretending like they aren’t the ones with the power to actually do the research our kids deserve. because they don’t actually care about our kids. They care about politics.

The reality of modern medicine is that doctors now want top-cover for prescribing medications- particularly in kids. Guanfacine was able to become common before those pressures shifted.

The only way we can really provide that top-cover is adding it to the label. If a doctor isn't satisfied there's a good risk-benefit tradeoff based on the available data, then they obviously don't need to prescribe it. It's not like they're trying to make this available OTC without a prescription.

Forgive me if I expect more from the people and institutions literally in charge of making the determinations of what can be prescribed safely. That’s the insane part. You’re saying that because our research and prescribing systems are not ideal that the people in charge of our research and prescribing systems have no other choice but to shrug their shoulders and say “the system sucks, take whatever”?

The status quo basically is: "there aren't great medications, but you can try these things."

And let's be clear, if the FDA updates the label, that isn't telling people to "try whatever." It is telling people to talk to their doctors about Leucovorin for kids with autism. It doesn't make it directly available to parents or patients. It doesn't tell doctors they need to offer to everyone with autism, or to anyone at all. It just makes it available as an option at a lower professional and legal risk to the prescribing physician. And a clearer path for insurance coverage.

No matter how much you insist that nothing out of the ordinary happened here, we all know it did. And all for the purpose of aggrandizement of Trump, not for the purpose of helping our kids. Where’s the funding for additional studies on leucovorin? maybe that was included in the announcement and I missed it.

You honestly sounds so childish. Just because you don’t know anything about people involved in the approval process of other things does not mean that they’re good people either. A lot of autistic kids were already taking this medication and as you can see from the SN section there have been people trying to get access to this medication since well before this and if Trump can make that happen even for his own crappy reasons then who tf cares? Not every parent wants to wait for additional studies and there are 50+ years of data on safety. And no my kid does not take leucovorin.

It’s childish to say that kids with autism actually deserve the best research and not quackery? OK.

Anonymous wrote:

Anonymous wrote:We live in NW but go to an autism specialist who actually has authored many studies on Leucovorin and autism. Look up drs Frye and Rossignol. They have data going back years. My dd has been on it for 5 years. They don’t put all of their patients on it. You need to do a FRAT test first to see if you have antibodies, etc. I hate that now everyone is jumping on board, regardless of if it will be effective. It’s not going to be effective for a large percentage of autism patients who don’t have a positive on the FRAT test.

It hasn't been widely studied, but folate receptor autoantibodies seem to have high prevalence in kids with autism-- perhaps as high as 75%.

But it is pretty incestuous research- basically all going back to Frye. That's suspicious. Either it is an incredibly interesting research that much of the medical community has been largely ignoring for unknown reasons, they're cooking the numbers somehow.

Not really that odd for researchers to specialize in a certain area.

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Anonymous wrote:I would love to hear other people experiences with Leucovorin

Because we’re doing science by anecdote now I guess.

Ever hear of case studies?

Case studies are not the kind of evidence the FDA generally uses to determine the safety and efficacy of a medication.

It's been used for 70 years. We already know it's safe.

They put cocaine in cough syrup for 70 yesrs

Do you not realize that Leucovorin continues to be used?

… in cancer. Stop lying.

You compared the safety record of Leucovorin to the safety record cocaine. I'm not the one being disingenuous. You can argue we don't know how effective it is for ASD, but we already know it's safe.

That wasn’t me but for the record cocaine actually does have medical uses right now (as a topical anesthesia).

So do you think that makes the safety record of cocaine similar to the safety record of Leucovorin? Otherwise, what's your point?

The point is that saying a drug is safe and effective for one indication says literally nothing at all about whether it is safe and effective for a wholly different indication. If you cannot grasp this entirely basic and fundamental point then you probably shouldn’t be in this discussion.

Again, we don't know it is effective, but we do know it is safe. Safe doesn't necessarily mean there's absolutely no possibility of risk. We approve drugs and other substances while there is still small potential for risks, with after-market monitoring being used to catch exceptional events. Leucovorin has the substantial benefit over new drugs in that we already have a long safety history with the drug.

It's ridiculous to suggest it isn't safe. Particularly given the risks of other things that are available and generally accepted as safe- including prescription medications, supplements, and food ingredients.

No we do NOT KNOW if it is safe in the population it is now being touted for. It has side effects that absolutely could be more unsafe for kids with autism vs adults with cancer. Specifically, seizures and aggression are known side effects and these are bigger concerns for autism. AND there is also research connecting too much prenatal folate to autism.

We.do.not.know.

On that basis, almost nothing is "safe" for use in kids with autism because these kids often aren't part of clinical trial populations. Since you're saying a safety record for the general population shouldn't be used to infer safety in a subpopulation.

Again, you're being disingenuous. This is done all the time. Heck, look how often drugs get prescribed off-label because of how hard it is to run trials (particularly in kids).

Frankly, off-label use here would seem to be the right move, too. But clearly something has happened over the last 10 years, and particularly with this drug, to make some doctors lose their ability to weigh risks and potential benefits rationally and in the best interest of their patients. Why are they treating it so differently than something like guanfacine, another drug with a long safety history that is frequently prescribed for young kids with autism presenting with aggressive or self-injurious behaviors, despite those being off-label.

This is a drug being specific touted FOR kids with autism. So yes, it is relevant to ask how it specifically affects them. And of course the whole point is that this went far beyond off-label use, departing from how additional uses are added and making overblown claims not supported by the evidence.

More importantly while it may be an understandable stance for an individual parent with their doctor to use a med off-label under the background of slow or nonexistent goldstar research - that is far different from the people *literally in charge of the research* upending it. Trump and RFK jr are pretending like they aren’t the ones with the power to actually do the research our kids deserve. because they don’t actually care about our kids. They care about politics.

The reality of modern medicine is that doctors now want top-cover for prescribing medications- particularly in kids. Guanfacine was able to become common before those pressures shifted.

The only way we can really provide that top-cover is adding it to the label. If a doctor isn't satisfied there's a good risk-benefit tradeoff based on the available data, then they obviously don't need to prescribe it. It's not like they're trying to make this available OTC without a prescription.

Forgive me if I expect more from the people and institutions literally in charge of making the determinations of what can be prescribed safely. That’s the insane part. You’re saying that because our research and prescribing systems are not ideal that the people in charge of our research and prescribing systems have no other choice but to shrug their shoulders and say “the system sucks, take whatever”?

The status quo basically is: "there aren't great medications, but you can try these things."

And let's be clear, if the FDA updates the label, that isn't telling people to "try whatever." It is telling people to talk to their doctors about Leucovorin for kids with autism. It doesn't make it directly available to parents or patients. It doesn't tell doctors they need to offer to everyone with autism, or to anyone at all. It just makes it available as an option at a lower professional and legal risk to the prescribing physician. And a clearer path for insurance coverage.

No matter how much you insist that nothing out of the ordinary happened here, we all know it did. And all for the purpose of aggrandizement of Trump, not for the purpose of helping our kids. Where’s the funding for additional studies on leucovorin? maybe that was included in the announcement and I missed it.

You honestly sounds so childish. Just because you don’t know anything about people involved in the approval process of other things does not mean that they’re good people either. A lot of autistic kids were already taking this medication and as you can see from the SN section there have been people trying to get access to this medication since well before this and if Trump can make that happen even for his own crappy reasons then who tf cares? Not every parent wants to wait for additional studies and there are 50+ years of data on safety. And no my kid does not take leucovorin.

Anonymous wrote:We live in NW but go to an autism specialist who actually has authored many studies on Leucovorin and autism. Look up drs Frye and Rossignol. They have data going back years. My dd has been on it for 5 years. They don’t put all of their patients on it. You need to do a FRAT test first to see if you have antibodies, etc. I hate that now everyone is jumping on board, regardless of if it will be effective. It’s not going to be effective for a large percentage of autism patients who don’t have a positive on the FRAT test.

It hasn't been widely studied, but folate receptor autoantibodies seem to have high prevalence in kids with autism-- perhaps as high as 75%.

But it is pretty incestuous research- basically all going back to Frye. That's suspicious. Either it is an incredibly interesting research that much of the medical community has been largely ignoring for unknown reasons, they're cooking the numbers somehow.

Anonymous wrote:We live in NW but go to an autism specialist who actually has authored many studies on Leucovorin and autism. Look up drs Frye and Rossignol. They have data going back years. My dd has been on it for 5 years. They don’t put all of their patients on it. You need to do a FRAT test first to see if you have antibodies, etc. I hate that now everyone is jumping on board, regardless of if it will be effective. It’s not going to be effective for a large percentage of autism patients who don’t have a positive on the FRAT test.

Can you share your daughter’s reaction to the treatment? Has it been effective? In which way? Thanks!

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Anonymous wrote:I'm really reticent to jump into this thread because it has turned so political and hostile, but I am surprised no one has mentioned Dr. Rosario Trifiletti in NJ. We came across his name on this board for PANS/PANDAS but he has spoken on the use of leucovorin for autism.

Due to the political angle, the thread drew a lot of attention from people without non-verbal kids. The reaction would have been completely different if Trump and RFK hadn't been involved in the press event.

The political angle IS the angle. And of course this is being touted for all kids with autism not just non-verbal kids. It’s not like it was some accident that Trumps and RFK Jr were involved.

Your just as guilty of the binary thinking by taking the opposite extreme- that we should withhold it from kids impacted by profound disabilities.

Trump and RFK didn't make up the 20 years of data or the two double-blind RCTs that have already been done. We wouldn't be having this discussion if this was a cancer drug, but a lot people don't particularly care about kids with profound autism because they don't directly see the impact that it has.

We wouldn’t be having this discussion about a cancer drug because Trump and RFK jr have not decided to upend and politicize cancer patients they way they have decided to do for autism. I think leucovorin and Tylenol should be studied and assessed using the NORMAL procedures already developed to ensure drugs are safe and effective. I think our kids deserve BETTER research not politicized publicity stunts.

Other administrations likely wouldn't have the narcissistic personalities insisting on making it a political event, but there certainly would have been public and political pressure to facilitate use.

You see this in more extreme cases- people pressuring the FDA to open up drugs that *don't* have established safety records for compassionate use.

They did a lot more here than compassionate use (which is generally on an individual level and a last ditch effort when the person is dying). Totally different from rushing a med for otherwise physically healthy *children*.

These aren't healthy children. They are children with a profound disabilities that have a short window of time during childhood to reach important developmental milestones.

Like "last ditch efforts" for dying cancer patients, this is worth substantial risk. And that's reflected by the side effects of the drugs approved and commonly prescribed for ASD, despite not being particularly effective.

In comparison, Leucovorin has a remarkable safety profile. Adjusting expectations/demands for efficacy accordingly, there's no rational cost-benefit analysis that wouldn't lead you to conclude it is worth a shot in kids profoundly impacted by autism.

You've hit the nail on the head. No one cares about autistic people. They aren't seen as worthy of help. They developed and rolled out a vaccine but completely overlooked a therapy for autism for 15 years.

People should be rioting in the street with pitchforks over this.

I think it has been a huge disservice to people with high support needs on the spectrum to group everyone together under a single diagnosis. "High-functioning" people with ASD aggressively push the narrative that there isn't anything wrong with ASD. They're the visible and vocal ones in society. As a result, there's isn't recognition that of the urgency of improved treatments for those who have more significant challenges.

I think that disconnect is a big part of the problem. Because if the first thing you think about when you hear ASD is a non-verbal and non-potty-trained kid, then you're going to understand why it makes sense to take bigger risks on medications.

Not that there's even much of a risk in this case. It's a cheap and safe drug.

Anonymous wrote:

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Anonymous wrote:I would love to hear other people experiences with Leucovorin

Because we’re doing science by anecdote now I guess.

Ever hear of case studies?

Case studies are not the kind of evidence the FDA generally uses to determine the safety and efficacy of a medication.

It's been used for 70 years. We already know it's safe.

They put cocaine in cough syrup for 70 yesrs

Do you not realize that Leucovorin continues to be used?

… in cancer. Stop lying.

You compared the safety record of Leucovorin to the safety record cocaine. I'm not the one being disingenuous. You can argue we don't know how effective it is for ASD, but we already know it's safe.

That wasn’t me but for the record cocaine actually does have medical uses right now (as a topical anesthesia).

So do you think that makes the safety record of cocaine similar to the safety record of Leucovorin? Otherwise, what's your point?

The point is that saying a drug is safe and effective for one indication says literally nothing at all about whether it is safe and effective for a wholly different indication. If you cannot grasp this entirely basic and fundamental point then you probably shouldn’t be in this discussion.

Again, we don't know it is effective, but we do know it is safe. Safe doesn't necessarily mean there's absolutely no possibility of risk. We approve drugs and other substances while there is still small potential for risks, with after-market monitoring being used to catch exceptional events. Leucovorin has the substantial benefit over new drugs in that we already have a long safety history with the drug.

It's ridiculous to suggest it isn't safe. Particularly given the risks of other things that are available and generally accepted as safe- including prescription medications, supplements, and food ingredients.

No we do NOT KNOW if it is safe in the population it is now being touted for. It has side effects that absolutely could be more unsafe for kids with autism vs adults with cancer. Specifically, seizures and aggression are known side effects and these are bigger concerns for autism. AND there is also research connecting too much prenatal folate to autism.

We.do.not.know.

On that basis, almost nothing is "safe" for use in kids with autism because these kids often aren't part of clinical trial populations. Since you're saying a safety record for the general population shouldn't be used to infer safety in a subpopulation.

Again, you're being disingenuous. This is done all the time. Heck, look how often drugs get prescribed off-label because of how hard it is to run trials (particularly in kids).

Frankly, off-label use here would seem to be the right move, too. But clearly something has happened over the last 10 years, and particularly with this drug, to make some doctors lose their ability to weigh risks and potential benefits rationally and in the best interest of their patients. Why are they treating it so differently than something like guanfacine, another drug with a long safety history that is frequently prescribed for young kids with autism presenting with aggressive or self-injurious behaviors, despite those being off-label.

This is a drug being specific touted FOR kids with autism. So yes, it is relevant to ask how it specifically affects them. And of course the whole point is that this went far beyond off-label use, departing from how additional uses are added and making overblown claims not supported by the evidence.

More importantly while it may be an understandable stance for an individual parent with their doctor to use a med off-label under the background of slow or nonexistent goldstar research - that is far different from the people *literally in charge of the research* upending it. Trump and RFK jr are pretending like they aren’t the ones with the power to actually do the research our kids deserve. because they don’t actually care about our kids. They care about politics.

The reality of modern medicine is that doctors now want top-cover for prescribing medications- particularly in kids. Guanfacine was able to become common before those pressures shifted.

The only way we can really provide that top-cover is adding it to the label. If a doctor isn't satisfied there's a good risk-benefit tradeoff based on the available data, then they obviously don't need to prescribe it. It's not like they're trying to make this available OTC without a prescription.

Forgive me if I expect more from the people and institutions literally in charge of making the determinations of what can be prescribed safely. That’s the insane part. You’re saying that because our research and prescribing systems are not ideal that the people in charge of our research and prescribing systems have no other choice but to shrug their shoulders and say “the system sucks, take whatever”?

The status quo basically is: "there aren't great medications, but you can try these things."

And let's be clear, if the FDA updates the label, that isn't telling people to "try whatever." It is telling people to talk to their doctors about Leucovorin for kids with autism. It doesn't make it directly available to parents or patients. It doesn't tell doctors they need to offer to everyone with autism, or to anyone at all. It just makes it available as an option at a lower professional and legal risk to the prescribing physician. And a clearer path for insurance coverage.

No matter how much you insist that nothing out of the ordinary happened here, we all know it did. And all for the purpose of aggrandizement of Trump, not for the purpose of helping our kids. Where’s the funding for additional studies on leucovorin? maybe that was included in the announcement and I missed it.

I didn't say wasn't out of the ordinary. Certainly the political participation was unusual. And the size of the RCTs is small. When a drug is already approved, it is common for trials to be smaller, particularly in pediatric patients, but these trials are particularly small.

In an ideal world, this would be handled with off-label prescribing. But things have shifted so doctors are less comfortable with that in kids. So it is useful for the FDA to take a public position that it is safe and appropriate to try this medication. Maybe there could be some sort of interim or intermediate level of approval/support, but I don't really see the point of that given that it still requires a prescription.

I don't doubt there was political pressure here. And if I was FDA fed staff, I think I'd be uncomfortable with the idea of basically taking a position on incomplete data. I'm sure I'd instead say that should be left to the doctor and the patient to weigh the risks and benefits and prescribe off-label where appropriate. But doctors are resistant to doing that. And if FDA staff thought this was truly dangerous, I would absolutely expect to see resignations.

The opposition to the labeling change here seems to be driven by people opposed to the move in principle, rather than actual concerns about harms. Sometimes it's good to draw those firm lines, but here we have a case where kids are being harmed by the lack of treatments. And for kids today, there's a short window of time available to change the rest of their lives. The standard by which we judge the use of medication in these cases should be much closer to those used to allow compassionate use in dying patients. And the data on safety and efficacy with Leucovorin is well past that.

If you've got a kid that's 6-8 years old right now, it's basically now or never for them. The next couple of years will determine whether they're able to go down a path to graduation or whether they will be effectively institutionalized. I'll admit I'm desperate, but I think that is wholly rational under the circumstances.

Anonymous wrote:

Anonymous wrote:We live in NW but go to an autism specialist who actually has authored many studies on Leucovorin and autism. Look up drs Frye and Rossignol. They have data going back years. My dd has been on it for 5 years. They don’t put all of their patients on it. You need to do a FRAT test first to see if you have antibodies, etc. I hate that now everyone is jumping on board, regardless of if it will be effective. It’s not going to be effective for a large percentage of autism patients who don’t have a positive on the FRAT test.

The FRAT is having a 9 week turn around time (after the two additional weeks it takes tonarrive)..thats not an ok amount of time to wait when so much depends on getting help quickly while the brain is developing.
Its also three hundred dollars plus the cost of the blood draw which makes it inequitable.

Dude I’m sorry but that is just not how this works. You can’t do medical science by panic.

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Anonymous wrote:I'm really reticent to jump into this thread because it has turned so political and hostile, but I am surprised no one has mentioned Dr. Rosario Trifiletti in NJ. We came across his name on this board for PANS/PANDAS but he has spoken on the use of leucovorin for autism.

Due to the political angle, the thread drew a lot of attention from people without non-verbal kids. The reaction would have been completely different if Trump and RFK hadn't been involved in the press event.

The political angle IS the angle. And of course this is being touted for all kids with autism not just non-verbal kids. It’s not like it was some accident that Trumps and RFK Jr were involved.

Your just as guilty of the binary thinking by taking the opposite extreme- that we should withhold it from kids impacted by profound disabilities.

Trump and RFK didn't make up the 20 years of data or the two double-blind RCTs that have already been done. We wouldn't be having this discussion if this was a cancer drug, but a lot people don't particularly care about kids with profound autism because they don't directly see the impact that it has.

We wouldn’t be having this discussion about a cancer drug because Trump and RFK jr have not decided to upend and politicize cancer patients they way they have decided to do for autism. I think leucovorin and Tylenol should be studied and assessed using the NORMAL procedures already developed to ensure drugs are safe and effective. I think our kids deserve BETTER research not politicized publicity stunts.

Other administrations likely wouldn't have the narcissistic personalities insisting on making it a political event, but there certainly would have been public and political pressure to facilitate use.

You see this in more extreme cases- people pressuring the FDA to open up drugs that *don't* have established safety records for compassionate use.

They did a lot more here than compassionate use (which is generally on an individual level and a last ditch effort when the person is dying). Totally different from rushing a med for otherwise physically healthy *children*.

These aren't healthy children. They are children with a profound disabilities that have a short window of time during childhood to reach important developmental milestones.

Like "last ditch efforts" for dying cancer patients, this is worth substantial risk. And that's reflected by the side effects of the drugs approved and commonly prescribed for ASD, despite not being particularly effective.

In comparison, Leucovorin has a remarkable safety profile. Adjusting expectations/demands for efficacy accordingly, there's no rational cost-benefit analysis that wouldn't lead you to conclude it is worth a shot in kids profoundly impacted by autism.

You've hit the nail on the head. No one cares about autistic people. They aren't seen as worthy of help. They developed and rolled out a vaccine but completely overlooked a therapy for autism for 15 years.

People should be rioting in the street with pitchforks over this.

Anonymous wrote:We live in NW but go to an autism specialist who actually has authored many studies on Leucovorin and autism. Look up drs Frye and Rossignol. They have data going back years. My dd has been on it for 5 years. They don’t put all of their patients on it. You need to do a FRAT test first to see if you have antibodies, etc. I hate that now everyone is jumping on board, regardless of if it will be effective. It’s not going to be effective for a large percentage of autism patients who don’t have a positive on the FRAT test.

The FRAT is having a 9 week turn around time (after the two additional weeks it takes tonarrive)..thats not an ok amount of time to wait when so much depends on getting help quickly while the brain is developing.
Its also three hundred dollars plus the cost of the blood draw which makes it inequitable.

Anonymous wrote:We live in NW but go to an autism specialist who actually has authored many studies on Leucovorin and autism. Look up drs Frye and Rossignol. They have data going back years. My dd has been on it for 5 years. They don’t put all of their patients on it. You need to do a FRAT test first to see if you have antibodies, etc. I hate that now everyone is jumping on board, regardless of if it will be effective. It’s not going to be effective for a large percentage of autism patients who don’t have a positive on the FRAT test.

And this is why guidance is needed.

Folks you really will have to do your own research in medical journals from now on out.

We live in NW but go to an autism specialist who actually has authored many studies on Leucovorin and autism. Look up drs Frye and Rossignol. They have data going back years. My dd has been on it for 5 years. They don’t put all of their patients on it. You need to do a FRAT test first to see if you have antibodies, etc. I hate that now everyone is jumping on board, regardless of if it will be effective. It’s not going to be effective for a large percentage of autism patients who don’t have a positive on the FRAT test.

Anonymous wrote:

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Anonymous wrote:

Anonymous wrote:I would love to hear other people experiences with Leucovorin

Because we’re doing science by anecdote now I guess.

Ever hear of case studies?

Case studies are not the kind of evidence the FDA generally uses to determine the safety and efficacy of a medication.

It's been used for 70 years. We already know it's safe.

They put cocaine in cough syrup for 70 yesrs

Do you not realize that Leucovorin continues to be used?

… in cancer. Stop lying.

You compared the safety record of Leucovorin to the safety record cocaine. I'm not the one being disingenuous. You can argue we don't know how effective it is for ASD, but we already know it's safe.

That wasn’t me but for the record cocaine actually does have medical uses right now (as a topical anesthesia).

So do you think that makes the safety record of cocaine similar to the safety record of Leucovorin? Otherwise, what's your point?

The point is that saying a drug is safe and effective for one indication says literally nothing at all about whether it is safe and effective for a wholly different indication. If you cannot grasp this entirely basic and fundamental point then you probably shouldn’t be in this discussion.

Again, we don't know it is effective, but we do know it is safe. Safe doesn't necessarily mean there's absolutely no possibility of risk. We approve drugs and other substances while there is still small potential for risks, with after-market monitoring being used to catch exceptional events. Leucovorin has the substantial benefit over new drugs in that we already have a long safety history with the drug.

It's ridiculous to suggest it isn't safe. Particularly given the risks of other things that are available and generally accepted as safe- including prescription medications, supplements, and food ingredients.

No we do NOT KNOW if it is safe in the population it is now being touted for. It has side effects that absolutely could be more unsafe for kids with autism vs adults with cancer. Specifically, seizures and aggression are known side effects and these are bigger concerns for autism. AND there is also research connecting too much prenatal folate to autism.

We.do.not.know.

On that basis, almost nothing is "safe" for use in kids with autism because these kids often aren't part of clinical trial populations. Since you're saying a safety record for the general population shouldn't be used to infer safety in a subpopulation.

Again, you're being disingenuous. This is done all the time. Heck, look how often drugs get prescribed off-label because of how hard it is to run trials (particularly in kids).

Frankly, off-label use here would seem to be the right move, too. But clearly something has happened over the last 10 years, and particularly with this drug, to make some doctors lose their ability to weigh risks and potential benefits rationally and in the best interest of their patients. Why are they treating it so differently than something like guanfacine, another drug with a long safety history that is frequently prescribed for young kids with autism presenting with aggressive or self-injurious behaviors, despite those being off-label.

This is a drug being specific touted FOR kids with autism. So yes, it is relevant to ask how it specifically affects them. And of course the whole point is that this went far beyond off-label use, departing from how additional uses are added and making overblown claims not supported by the evidence.

More importantly while it may be an understandable stance for an individual parent with their doctor to use a med off-label under the background of slow or nonexistent goldstar research - that is far different from the people *literally in charge of the research* upending it. Trump and RFK jr are pretending like they aren’t the ones with the power to actually do the research our kids deserve. because they don’t actually care about our kids. They care about politics.

The reality of modern medicine is that doctors now want top-cover for prescribing medications- particularly in kids. Guanfacine was able to become common before those pressures shifted.

The only way we can really provide that top-cover is adding it to the label. If a doctor isn't satisfied there's a good risk-benefit tradeoff based on the available data, then they obviously don't need to prescribe it. It's not like they're trying to make this available OTC without a prescription.

Forgive me if I expect more from the people and institutions literally in charge of making the determinations of what can be prescribed safely. That’s the insane part. You’re saying that because our research and prescribing systems are not ideal that the people in charge of our research and prescribing systems have no other choice but to shrug their shoulders and say “the system sucks, take whatever”?

The status quo basically is: "there aren't great medications, but you can try these things."

And let's be clear, if the FDA updates the label, that isn't telling people to "try whatever." It is telling people to talk to their doctors about Leucovorin for kids with autism. It doesn't make it directly available to parents or patients. It doesn't tell doctors they need to offer to everyone with autism, or to anyone at all. It just makes it available as an option at a lower professional and legal risk to the prescribing physician. And a clearer path for insurance coverage.

No matter how much you insist that nothing out of the ordinary happened here, we all know it did. And all for the purpose of aggrandizement of Trump, not for the purpose of helping our kids. Where’s the funding for additional studies on leucovorin? maybe that was included in the announcement and I missed it.

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Anonymous wrote:I would love to hear other people experiences with Leucovorin

Because we’re doing science by anecdote now I guess.

Ever hear of case studies?

Case studies are not the kind of evidence the FDA generally uses to determine the safety and efficacy of a medication.

It's been used for 70 years. We already know it's safe.

They put cocaine in cough syrup for 70 yesrs

Do you not realize that Leucovorin continues to be used?

… in cancer. Stop lying.

You compared the safety record of Leucovorin to the safety record cocaine. I'm not the one being disingenuous. You can argue we don't know how effective it is for ASD, but we already know it's safe.

That wasn’t me but for the record cocaine actually does have medical uses right now (as a topical anesthesia).

So do you think that makes the safety record of cocaine similar to the safety record of Leucovorin? Otherwise, what's your point?

The point is that saying a drug is safe and effective for one indication says literally nothing at all about whether it is safe and effective for a wholly different indication. If you cannot grasp this entirely basic and fundamental point then you probably shouldn’t be in this discussion.

Again, we don't know it is effective, but we do know it is safe. Safe doesn't necessarily mean there's absolutely no possibility of risk. We approve drugs and other substances while there is still small potential for risks, with after-market monitoring being used to catch exceptional events. Leucovorin has the substantial benefit over new drugs in that we already have a long safety history with the drug.

It's ridiculous to suggest it isn't safe. Particularly given the risks of other things that are available and generally accepted as safe- including prescription medications, supplements, and food ingredients.

No we do NOT KNOW if it is safe in the population it is now being touted for. It has side effects that absolutely could be more unsafe for kids with autism vs adults with cancer. Specifically, seizures and aggression are known side effects and these are bigger concerns for autism. AND there is also research connecting too much prenatal folate to autism.

We.do.not.know.

On that basis, almost nothing is "safe" for use in kids with autism because these kids often aren't part of clinical trial populations. Since you're saying a safety record for the general population shouldn't be used to infer safety in a subpopulation.

Again, you're being disingenuous. This is done all the time. Heck, look how often drugs get prescribed off-label because of how hard it is to run trials (particularly in kids).

Frankly, off-label use here would seem to be the right move, too. But clearly something has happened over the last 10 years, and particularly with this drug, to make some doctors lose their ability to weigh risks and potential benefits rationally and in the best interest of their patients. Why are they treating it so differently than something like guanfacine, another drug with a long safety history that is frequently prescribed for young kids with autism presenting with aggressive or self-injurious behaviors, despite those being off-label.

This is a drug being specific touted FOR kids with autism. So yes, it is relevant to ask how it specifically affects them. And of course the whole point is that this went far beyond off-label use, departing from how additional uses are added and making overblown claims not supported by the evidence.

More importantly while it may be an understandable stance for an individual parent with their doctor to use a med off-label under the background of slow or nonexistent goldstar research - that is far different from the people *literally in charge of the research* upending it. Trump and RFK jr are pretending like they aren’t the ones with the power to actually do the research our kids deserve. because they don’t actually care about our kids. They care about politics.

The reality of modern medicine is that doctors now want top-cover for prescribing medications- particularly in kids. Guanfacine was able to become common before those pressures shifted.

The only way we can really provide that top-cover is adding it to the label. If a doctor isn't satisfied there's a good risk-benefit tradeoff based on the available data, then they obviously don't need to prescribe it. It's not like they're trying to make this available OTC without a prescription.

Forgive me if I expect more from the people and institutions literally in charge of making the determinations of what can be prescribed safely. That’s the insane part. You’re saying that because our research and prescribing systems are not ideal that the people in charge of our research and prescribing systems have no other choice but to shrug their shoulders and say “the system sucks, take whatever”?

The status quo basically is: "there aren't great medications, but you can try these things."

And let's be clear, if the FDA updates the label, that isn't telling people to "try whatever." It is telling people to talk to their doctors about Leucovorin for kids with autism. It doesn't make it directly available to parents or patients. It doesn't tell doctors they need to offer to everyone with autism, or to anyone at all. It just makes it available as an option at a lower professional and legal risk to the prescribing physician. And a clearer path for insurance coverage.

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Anonymous wrote:I'm really reticent to jump into this thread because it has turned so political and hostile, but I am surprised no one has mentioned Dr. Rosario Trifiletti in NJ. We came across his name on this board for PANS/PANDAS but he has spoken on the use of leucovorin for autism.

Due to the political angle, the thread drew a lot of attention from people without non-verbal kids. The reaction would have been completely different if Trump and RFK hadn't been involved in the press event.

The political angle IS the angle. And of course this is being touted for all kids with autism not just non-verbal kids. It’s not like it was some accident that Trumps and RFK Jr were involved.

Your just as guilty of the binary thinking by taking the opposite extreme- that we should withhold it from kids impacted by profound disabilities.

Trump and RFK didn't make up the 20 years of data or the two double-blind RCTs that have already been done. We wouldn't be having this discussion if this was a cancer drug, but a lot people don't particularly care about kids with profound autism because they don't directly see the impact that it has.

We wouldn’t be having this discussion about a cancer drug because Trump and RFK jr have not decided to upend and politicize cancer patients they way they have decided to do for autism. I think leucovorin and Tylenol should be studied and assessed using the NORMAL procedures already developed to ensure drugs are safe and effective. I think our kids deserve BETTER research not politicized publicity stunts.

Other administrations likely wouldn't have the narcissistic personalities insisting on making it a political event, but there certainly would have been public and political pressure to facilitate use.

You see this in more extreme cases- people pressuring the FDA to open up drugs that *don't* have established safety records for compassionate use.

They did a lot more here than compassionate use (which is generally on an individual level and a last ditch effort when the person is dying). Totally different from rushing a med for otherwise physically healthy *children*.

These aren't healthy children. They are children with a profound disabilities that have a short window of time during childhood to reach important developmental milestones.

Like "last ditch efforts" for dying cancer patients, this is worth substantial risk. And that's reflected by the side effects of the drugs approved and commonly prescribed for ASD, despite not being particularly effective.

In comparison, Leucovorin has a remarkable safety profile. Adjusting expectations/demands for efficacy accordingly, there's no rational cost-benefit analysis that wouldn't lead you to conclude it is worth a shot in kids profoundly impacted by autism.

I thought we were past the point where we disregarded any harms of autism therapy because autism is uniquely bad. Or are we back to bleach, chelation, shocks and Lovaas abuse? And the label is for autism not “severe autism.”

Also you need to stop comparing leucovorin to Abilify and Risperdal. Those meds are approved for specific severe autism symptoms (aggression) where the benefits may outweigh the risks. They are not for the core autism symptoms that Leucovorin is being touted for. They have nothing to do with each other.

Our kids deserve the best in research not incomplete research pushed by quacks.

"Severe autism" isn't a medical term with clear criteria. Even the severity levels are very limited in their ability to describe the symptoms and needs of a patient. The idea that the label is apparently being updated for "autism" does not mean it is appropriate for any patient with autism. That's why doctors need to evaluate patients and determine medications.

Also, the labels for risperidone and Abilify aren't as narrow as you suggest. The label is for "irritability." Of course, you're right that that doctors will generally attempt to try other (often off-label) medications before prescribing risperidone or Abilify, or will reserve it for cases presenting with the most severe or dangerous symptoms, but the label gives doctors, patients, and parents the ability to make the appropriate cost-benefit determinations.