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

[Anonymous]

Anonymous wrote:

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.

It is odd for other researchers to not pick up promising research areas from
others.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

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.

It is odd for other researchers to not pick up promising research areas from
others.

I think that there was research interest in this but it was extremely premature for Trump and RFK Jr to leap over all the normal processes. Arguably there was less incentive to research this med because it was generic already. But … ya know … Trump and RFK could have announced that they were funding such research instead of what they actually did.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.

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.

DP. Conducting the best research doesn't have to mean also waiting years before trying safe drugs.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

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.

It is odd for other researchers to not pick up promising research areas from
others.

You know what actually would have been great for RFK Jr to do? Announce an effort to assess which research efforts have the most potential and deserve the most federal funding. The search for genetic causes has taken up too much bandwidth - perhaps it is time to move on from that. perhaps it is time to focus less on the search for causes and more on effective therapies and treatments. Or perhaps it is time to redefine the categories so scientists can search for the causes of the more disabling forms of autism. But of course, this kind of effort would take time and resources and not allow brainworm to pretend like he alone was conquering the evil FDA.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.

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.

DP. Conducting the best research doesn't have to mean also waiting years before trying safe drugs.

Yes it actually does. I’m not sure how many times you need that repeated.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.

It is odd for other researchers to not pick up promising research areas from
others.

I think that there was research interest in this but it was extremely premature for Trump and RFK Jr to leap over all the normal processes. Arguably there was less incentive to research this med because it was generic already. But … ya know … Trump and RFK could have announced that they were funding such research instead of what they actually did.

That's not how grant programs work. They fund projects from the proposals submitted. If no one submitted a Leucovorin trial proposal, they couldn't fund one through the ADSI. Maybe they'll get one next year based on this.

But trials take time. And kids don't have time to waste.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.

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.

DP. Conducting the best research doesn't have to mean also waiting years before trying safe drugs.

Yes it actually does. I’m not sure how many times you need that repeated.

It really doesn't. When to start using a drug is based on risk-benefit. This is a low-risk drug with promising benefits.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.

It is odd for other researchers to not pick up promising research areas from
others.

You know what actually would have been great for RFK Jr to do? Announce an effort to assess which research efforts have the most potential and deserve the most federal funding. The search for genetic causes has taken up too much bandwidth - perhaps it is time to move on from that. perhaps it is time to focus less on the search for causes and more on effective therapies and treatments. Or perhaps it is time to redefine the categories so scientists can search for the causes of the more disabling forms of autism. But of course, this kind of effort would take time and resources and not allow brainworm to pretend like he alone was conquering the evil FDA.

You trust a centralized effort to do that more than distributed grant proposal reviews by subject matter experts?

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.

It is odd for other researchers to not pick up promising research areas from
others.

I think that there was research interest in this but it was extremely premature for Trump and RFK Jr to leap over all the normal processes. Arguably there was less incentive to research this med because it was generic already. But … ya know … Trump and RFK could have announced that they were funding such research instead of what they actually did.

That's not how grant programs work. They fund projects from the proposals submitted. If no one submitted a Leucovorin trial proposal, they couldn't fund one through the ADSI. Maybe they'll get one next year based on this.

But trials take time. And kids don't have time to waste.

So you’re saying the FDA has no ability to create research priorities and strategically fund? Yeah right. And kids don’t have time to take untested and potentially harmful medications. Kids with autism are not guinea pigs and there is a LONG shameful history of subjecting them to untested and harmful therapies and medications.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.

It is odd for other researchers to not pick up promising research areas from
others.

You know what actually would have been great for RFK Jr to do? Announce an effort to assess which research efforts have the most potential and deserve the most federal funding. The search for genetic causes has taken up too much bandwidth - perhaps it is time to move on from that. perhaps it is time to focus less on the search for causes and more on effective therapies and treatments. Or perhaps it is time to redefine the categories so scientists can search for the causes of the more disabling forms of autism. But of course, this kind of effort would take time and resources and not allow brainworm to pretend like he alone was conquering the evil FDA.

You trust a centralized effort to do that more than distributed grant proposal reviews by subject matter experts?

Dude. You’re acting like the president and the head of HHS have no power to strategically shape federal and federally funded research. I can’t figure out if you are ignorant or doing this on purpose.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.

It is odd for other researchers to not pick up promising research areas from
others.

I think that there was research interest in this but it was extremely premature for Trump and RFK Jr to leap over all the normal processes. Arguably there was less incentive to research this med because it was generic already. But … ya know … Trump and RFK could have announced that they were funding such research instead of what they actually did.

Other researchers have looking at Leucovorin but there doesn't seem to much research on the folate receptor autoantibody association..

[Anonymous]

RFK jr himself has said, “I don’t think people should be taking medical advice from me.”
So there you are, come to your own conclusions.
RFK jr seemingly has told trump thet melania caused Baron’s condition and recommended leucovorin. I guess trump thinks it worked.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

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.

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.

DP. Conducting the best research doesn't have to mean also waiting years before trying safe drugs.

Yes it actually does. I’m not sure how many times you need that repeated.

It really doesn't. When to start using a drug is based on risk-benefit. This is a low-risk drug with promising benefits.

No it is is not. It is an untested drug and we don’t know the risks and benefits for the class of kids it is being targeted to.

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

“ The September 22 press conference held by U.S. Health and Human Services alarms us researchers … The data cited do not support the claim that Tylenol causes autism and leucovorin is a cure, and only stoke fear and falsely suggest hope when there is no simple answer.”

“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.”

https://www.thetransmitter.org/spectrum/autism-experts-question-hhs-statements-on-tylenol-leucovorin/

[Anonymous]

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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.

It is odd for other researchers to not pick up promising research areas from
others.

You know what actually would have been great for RFK Jr to do? Announce an effort to assess which research efforts have the most potential and deserve the most federal funding. The search for genetic causes has taken up too much bandwidth - perhaps it is time to move on from that. perhaps it is time to focus less on the search for causes and more on effective therapies and treatments. Or perhaps it is time to redefine the categories so scientists can search for the causes of the more disabling forms of autism. But of course, this kind of effort would take time and resources and not allow brainworm to pretend like he alone was conquering the evil FDA.

You trust a centralized effort to do that more than distributed grant proposal reviews by subject matter experts?

Dude. You’re acting like the president and the head of HHS have no power to strategically shape federal and federally funded research. I can’t figure out if you are ignorant or doing this on purpose.

They certainly do. And they certainly have. What I don't get is why you want them to do that even more versus having the grant reviewers rate them on their merits.

I'd admit I haven't been a part of FDA or NIH grant review proposes, but I've done a part of them at several other agencies. I imagine it is similar. I don't think you understand the process of how grants get funded.

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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.

DP. Conducting the best research doesn't have to mean also waiting years before trying safe drugs.

Yes it actually does. I’m not sure how many times you need that repeated.

It really doesn't. When to start using a drug is based on risk-benefit. This is a low-risk drug with promising benefits.

No it is is not. It is an untested drug and we don’t know the risks and benefits for the class of kids it is being targeted to.

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

“ The September 22 press conference held by U.S. Health and Human Services alarms us researchers … The data cited do not support the claim that Tylenol causes autism and leucovorin is a cure, and only stoke fear and falsely suggest hope when there is no simple answer.”

“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.”

https://www.thetransmitter.org/spectrum/autism-experts-question-hhs-statements-on-tylenol-leucovorin/

It's not an "untested drug". The quality of the data is limited, but it isn't untested. Safety trials very frequently don't closely match the expected or intended population. The efficacy trials have been small, but at least four RCTs have had positive results.