Jerry Silver and Other Discussion from ChinaSCINet Update

[crabbyshark]

What?! Sorry but this is nonsense. Animal studies are significantly shorter than human trials. Every potential therapy (if possible) should be tested in a complete, chronic model before going to trial, in my opinion. Your view would only make sense if everything could go to trial collectively at the same time... Obviously the animal models wouldn't occur that way either, but a whole hell of a lot faster. If you want simply any therapy to go to trial, even if it hasn't demonstrated efficacy in a comparable animal model, I hope you're ready to sit through a bunch of failures or that you're ok with rolling the dice and waiting 5+ years per trial to even see what lands.

The specific combination UCBMC+MP+Lithium therapy, to my knowledge, wasn't tested in a chronic SCI animal model before being taken to trial in humans.

For a therapy to be tried in humans, the therapy simply has to be determined to be safe. It does not have to be determined to be efficacious. Failure is a part of learning. If it fails, it fails, but at least we know.

Ibuprofen is well known, cheap and easily available. There is evidence ibuprofen significantly helps animals when administered during acute spinal cord injury. The science behind the way ibuprofen affects axons suggests ibuprofen might be beneficial for those with chronic SCI.

It would be more than feasible to take 200 people with chronic spinal cord injury and split them up into two groups - placebo and ibuprofen, administer the medicine for 12 or 24 months, then determine if the ibuprofen group was any better than the placebo group at the end of the trial.

[ay2012]

The specific combination UCBMC+MP+Lithium therapy, to my knowledge, wasn't tested in a chronic SCI animal model before being taken to trial in humans.

For a therapy to be tried in humans, the therapy simply has to be determined to be safe. It does not have to be determined to be efficacious. Failure is a part of learning. If it fails, it fails, but at least we know.

Ibuprofen is well known, cheap and easily available. There is evidence ibuprofen significantly helps animals when administered during acute spinal cord injury. The science behind the way ibuprofen affects axons suggests ibuprofen might be beneficial for those with chronic SCI.

It would be more than feasible to take 200 people with chronic spinal cord injury and split them up into two groups - placebo and ibuprofen, administer the medicine for 12 or 24 months, then determine if the ibuprofen group was any better than the placebo group at the end of the trial.

This would still cost money. At the expense of possibly trying another therapy. I know that UCBMC weren't tested in a chronic animal setting. That's why people were justifiably weary beforehand, and skeptical still, but less so because they seem to be showing some results.

[crabbyshark]

This would still cost money.

Any trial costs money. Animal trials cost money. And time.

Ibuprofen is well-known. Once all the parameters were set, a clinical trial of ibuprofen would be far cheaper than a clinical trial of any therapy that includes expensive drugs or major surgery. If it works or not, we learn something. Either way, relatively little resources are expended finding out.

[Fly_Pelican_Fly]

Any trial costs money. Animal trials cost money. And time.

Ibuprofen is well-known. Once all the parameters were set, a clinical trial of ibuprofen would be far cheaper than a clinical trial of any therapy that includes expensive drugs or major surgery. If it works or not, we learn something. Either way, relatively little resources are expended finding out.

Good luck finding a principal investigator, the venture capital and a trial infrastructure for this incredibly awesome idea!

[jsilver]

Asking whether ibuprofen can provide any clinically relevant recovery after chronic spinal cord injury is like asking whether a squirt gun might have helped to put out the fires in the twin towers. Sure, the squirt guns would have helped.

[NowhereMan]

The specific combination UCBMC+MP+Lithium therapy, to my knowledge, wasn't tested in a chronic SCI animal model before being taken to trial in humans.

For a therapy to be tried in humans, the therapy simply has to be determined to be safe. It does not have to be determined to be efficacious. Failure is a part of learning. If it fails, it fails, but at least we know.

Ibuprofen is well known, cheap and easily available. There is evidence ibuprofen significantly helps animals when administered during acute spinal cord injury. The science behind the way ibuprofen affects axons suggests ibuprofen might be beneficial for those with chronic SCI.

It would be more than feasible to take 200 people with chronic spinal cord injury and split them up into two groups - placebo and ibuprofen, administer the medicine for 12 or 24 months, then determine if the ibuprofen group was any better than the placebo group at the end of the trial.

The sad part is that this was the exact train of thought behind starting UCB + lithium trials (except for the placebo group).

Crabbyshark if you believe there is a reasonable chance that taking an Advil pill daily might be beneficial to chronic injury, why don't you start taking them right now? Let us know how much return you get back. It is dirt cheap and it is safe to take daily. People take it daily to prevent stroke. If I thought there was 1 chance out of a 100 that it would help I would do it in a heartbeat. You think there is a chance. Go ahead.

[Fly_Pelican_Fly]

We also need to be responsible here. Many newbies to SCI may just starting popping ibuprofen pills after reading these threads.

I remember when I was in hospital a few years back and the media was reporting that the blue dye in M&Ms had a neuroprotective effect. The patients within the entire spinal unit were popping M&Ms like nobody's business! Ibuprofen is as easy to purchase as M&Ms are. Be careful!

[Christopher Paddon]

The specific combination UCBMC+MP+Lithium therapy, to my knowledge, wasn't tested in a chronic SCI animal model before being taken to trial in humans.

For a therapy to be tried in humans, the therapy simply has to be determined to be safe. It does not have to be determined to be efficacious. Failure is a part of learning. If it fails, it fails, but at least we know.

Ibuprofen is well known, cheap and easily available. There is evidence ibuprofen significantly helps animals when administered during acute spinal cord injury. The science behind the way ibuprofen affects axons suggests ibuprofen might be beneficial for those with chronic SCI.

It would be more than feasible to take 200 people with chronic spinal cord injury and split them up into two groups - placebo and ibuprofen, administer the medicine for 12 or 24 months, then determine if the ibuprofen group was any better than the placebo group at the end of the trial.

This would seem to be a good argument for being very sceptical of the cord blood and lithium human trials.

[Wise Young]

We also need to be responsible here. Many newbies to SCI may just starting popping ibuprofen pills after reading these threads.

I remember when I was in hospital a few years back and the media was reporting that the blue dye in M&Ms had a neuroprotective effect. The patients within the entire spinal unit were popping M&Ms like nobody's business! Ibuprofen is as easy to purchase as M&Ms are. Be careful!

Pelican,

I agree that people should not be popping ibuprofen or indomethacin. On the other hand, that is not a reason to dismiss these findings as being bogus or unimportant. The results are significant and should be investigated further.

Wise.

[Wise Young]

I still can't see what taking aspirin has to do with chronic spinal cord injury. It may help reduce the chance of having a stroke (BEFORE a stroke happens, possibly by thinning the blood or reducing blood pressure? I don't know).

Where is the laboratory evidence that aspirin or ibuprofen etc etc can do anything to deal with the massive neurological deficit and scar tissue left that exist in a chronic sci or stroke for that matter?

Saying something helps prevent a disease or works in an acute injury situation and then extrapolating it to apply to a chronic injury situation seems illogical to me.

Christopher,

I am not advocating that people pop NSAIDs to treat their spinal cord injury and please don't suggest this. On the other hand, I don't think that people should be dismissing the effects of NSAIDs on chronic spinal cord injury. It should be studied.

Wise.

[Wise Young]

A perfect opportunity to do a side by side comparison of Cethrin and aspirin in chronic rats!

Yes, except that it should be done in combination with other therapies as well. Wise.

[Wise Young]

The sad part is that this was the exact train of thought behind starting UCB + lithium trials (except for the placebo group).

Crabbyshark if you believe there is a reasonable chance that taking an Advil pill daily might be beneficial to chronic injury, why don't you start taking them right now? Let us know how much return you get back. It is dirt cheap and it is safe to take daily. People take it daily to prevent stroke. If I thought there was 1 chance out of a 100 that it would help I would do it in a heartbeat. You think there is a chance. Go ahead.

NowhereMan,

It is not true that there is enough evidence to support a daily Advil pill. We don't know enough about this therapy, the dose, and its effect on the chronically injured spinal cord. On the other hand, it is unreasonable to dismiss an interesting and potentially effective therapy because there is no evidence that it works. If there were evidence that it doesn't work, then it would be reasonable to dismiss it. But, such evidence is not yet available.

Wise.

[ay2012]

On the other hand, it is unreasonable to dismiss an interesting and potentially effective therapy because there is no evidence that it works. If there were evidence that it doesn't work, then it would be reasonable to dismiss it.

Hmmm...isn't that quite an atheoretical statement? No disproving empirical evidence surely isn't the only criteria in testing a potential therapy.....

[Christopher Paddon]

I would have thought that before human clinical trials start, animal studies should be required that prove safety and efficacy and the results issued in a quality scientific journal, followed by independent animal studies by another group to confirm the results.

We could all speculate forever as to interesting therapies which might or might not work
but an awful lot of time, money and possibly human health would be wasted if they were just tried on humans willy-nilly.

[GRAMMY]

If there were evidence that it doesn't work, then it would be reasonable to dismiss it. But, such evidence is not yet available.
Wise.

When will the Cethrin chronic rat study be scheduled in the lab?
What combination would be added other than aspirin for those chronic rats?