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

[Anonymous]

Anonymous wrote:I swear that if Trump said drinking lots of water was good for kids some of you would dehydrate your own offspring to death.

That is not what is doing on here at all. Your comment is typical of someone who understands nothing related to science or the scientific method.

[Anonymous]

Anonymous wrote:

Anonymous wrote:They’ve never done large scale studies to determine safety, dosing, side effects, etc.
sounds unsafe to me.

You mean like they didn’t for the COVID vaccine? I agree, unsafe.

Stop playing stupid games. Covid was a dangerous virus killing many people. There was an urgent need for a vaccine and it has proven to be safe.

[Anonymous]

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.

[Anonymous]

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.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:They’ve never done large scale studies to determine safety, dosing, side effects, etc.
sounds unsafe to me.

You mean like they didn’t for the COVID vaccine? I agree, unsafe.

Stop playing stupid games. Covid was a dangerous virus killing many people. There was an urgent need for a vaccine and it has proven to be safe.

And here we have a drug that has been proven to be safe with evidence that it can help some kids with profound disabilities. Every year that goes by means more kids, and families, whose lives will be irrevocably destroyed. There's an urgent need here, too.

[Anonymous]

It did not go through the standard FDA approval process. I know someone who works at FDA. You may want to see how a newly approved drug like this works on others before you jump into it.

[Anonymous]

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.

[Anonymous]

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.

Yeah here is my shocked face that the PANDAS doctors are branching out into leucovorin.

[Anonymous]

Anonymous wrote:

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.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:They’ve never done large scale studies to determine safety, dosing, side effects, etc.
sounds unsafe to me.

You mean like they didn’t for the COVID vaccine? I agree, unsafe.

Stop playing stupid games. Covid was a dangerous virus killing many people. There was an urgent need for a vaccine and it has proven to be safe.

And here we have a drug that has been proven to be safe with evidence that it can help some kids with profound disabilities. Every year that goes by means more kids, and families, whose lives will be irrevocably destroyed. There's an urgent need here, too.

If only we could do the actual research to find out if anything you wrote was true. That’s what is so psychotic about Trump’s HHS. Rushing certain treatments and claims for political gain while dismantling the research institutions that would actually tell us what works and what does not work.

[Anonymous]

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).

[Anonymous]

Anonymous wrote:It did not go through the standard FDA approval process. I know someone who works at FDA. You may want to see how a newly approved drug like this works on others before you jump into it.

Why? The new drugs are a crapshoot on efficacy and have substantially worse side effects and safety profiles. Even if it ultimately doesn't work, it's worth a try just as much as the more dangerous drugs that are on-label.

Also, understand that the processes for updating labels are different and much less rigorous than the processes for approving a drug. This drug has already been approved for 70 years. Off-label prescriptions are both allowed and common, although given the litigious nature of modern society, some doctors are very reluctant to prescribe off-label in kids until it becomes common practice by others. Updating the label will hopefully facilitate more data, and if informal experiences and future clinical trials don't pan out, they can remove it from the label. Since the drug isn't dangerous in any meaningful way, there's no harm.

[Anonymous]

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?

[Anonymous]

Anonymous wrote:

Anonymous wrote:

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.

[Anonymous]

Anonymous wrote:

Anonymous wrote:It did not go through the standard FDA approval process. I know someone who works at FDA. You may want to see how a newly approved drug like this works on others before you jump into it.

Why? The new drugs are a crapshoot on efficacy and have substantially worse side effects and safety profiles. Even if it ultimately doesn't work, it's worth a try just as much as the more dangerous drugs that are on-label.

Also, understand that the processes for updating labels are different and much less rigorous than the processes for approving a drug. This drug has already been approved for 70 years. Off-label prescriptions are both allowed and common, although given the litigious nature of modern society, some doctors are very reluctant to prescribe off-label in kids until it becomes common practice by others. Updating the label will hopefully facilitate more data, and if informal experiences and future clinical trials don't pan out, they can remove it from the label. Since the drug isn't dangerous in any meaningful way, there's no harm.

That's fine, try it if you want to. But it hasn't gone through a regular review and approval and you should know that before you start giving it to your kids. Just don't accept medical information from this administration blindly.