How likely is a UK rituximab trial?

[Gingergrrl]

No not lymphoma . It's just we used that as an example of the lack of knowledge . Ie that if he did get lymphoma they would treat him , but without the promise of ongoing treatment for ME we would refuse treatment . It was a hypothetical example . Sorry about confusion .

Thanks for clarifying and I thought you meant he had lymphoma (or potential lymphoma) and they were denying Rituximab (RTX). But you mean more of a political statement that even if he got lymphoma, he would refuse RTX unless it becomes available for ME/CFS patients?

 

[Jill]

Yep- meaning that the treatment would be pointless as the ME would remain and without ongoing ME care he'd refuse treatment because he'd be back where he started . All hypothetical . Even though we'd know whether he was a responder or not currently they'd have to deny ongoing treatment. He would sign his life away but they not even willing he to do a very small trial. The clinical director said he will review it when the stage 3 study is out. He is a good guy and trying to help but I think he shouldn't have got hopes up. I guess all these things have been stalling tactics, hoping he won't commit suicide which they know is his other option .

Thanks for clarifying and I thought you meant he had lymphoma (or potential lymphoma) and they were denying Rituximab (RTX). But you mean more of a political statement that even if he got lymphoma, he would refuse RTX unless it becomes available for ME/CFS patients?

pp

 

[Gingergrrl]

Yep- meaning that the treatment would be pointless as the ME would remain and without ongoing ME care he'd refuse treatment because he'd be back where he started

Although you'd at least know if he was a responder (but I agree if I got a treatment and was a responder and then it was taken away, this would be very challenging and I'd almost rather not know). I was a responder to IVIG and will soon have to stop it and if I revert back to how things were, I don't really know how I will cope with this. Although at least I will have the knowledge for the future that I was a responder.

All hypothetical

Agreed and I understand what you meant now.

I guess all these things have been stalling tactics, hoping he won't commit suicide which they know is his other option .

Stalling tactics are what the U.S. insurance companies bank on (they do this by saying that the doctor used the wrong form, they never received it b/c sent to the wrong fax #, ad nauseum...). The insurance companies would rather see you die than pay for an expensive treatment (and this is regardless of which political party is in power). I hope your partner will get Rituximab (RTX) some how, some day and that suicide will not even be an option.

 

[Jill]

@Gingergrrl , that's great that you responded to Ivig. I feel that we aren't investigated enough. Was there a way of testing to see if ivig might help. Was it given for ME or something else. I think I've read your posts and it's complicated but you are hoping to do rituxan as well aren't you ?
I've got them testing for antidiuerectuc hormone - atleast that's what I asked . What he's doing is a 24 hour urine collection plus a blood test after not drinking for 12 hours . I'm just glad we aren't paying for this neglect

 

[Gingergrrl]

@Gingergrrl, that's great that you responded to Ivig. I feel that we aren't investigated enough. Was there a way of testing to see if ivig might help. Was it given for ME or something else. I think I've read your posts and it's complicated but you are hoping to do rituxan as well aren't you?

There is no way to know in advance (without trying it) if someone will be a responder to IVIG (if that is what you are asking)? The only way is to try it. In my case it was high dose IVIG for auto immune antibodies (vs. low dose IVIG for immune deficiency). I started with low dose, then increased to a moderate dose and finally to high dose in Dec 2016 which I have been doing every three weeks. It's a big commitment and often challenging but has been worth it for me. Yes, my goal is to try Rituxan next with the hope that I will be a responder, per my doctor and research, since I was a responder to high dose IVIG and I have so many damn autoantibodies. Rituxan could wipe them out at production level and in theory, the new B-Cells could grow back healthy. No guarantees but I am more than willing to take the risk and would honestly do it tomorrow if it were approved for me. Hope this helps.

 

[Jo Best]

Last year I'd made a major complaint to the hospital that there was know one who was up to date - I think we are proving this point rapidly . I have suggested ( in s talk I gave at grand rounds) that someone be sent to the invest in ME conference so patients can be seen by someone who is up to speed. I will continue sending info but it lands on deaf ears currently .

Did you catch the news that Warren Tate is participating in the colloquium and conference this year?
I don't know anything about him so perhaps this won't help you.
I just wondered if it might give the hospital an extra nudge that going would be worthwhile, but then if they can't send a representative in person, they have the full presentations on DVD (assuming one will be produced again this year).

Invest in ME Research is pleased to announce that Professor Warren Tate is to participate in the #BRMEC7 colloquium and #IIMEC12 conference.

Professor Tate - from University of Otago in New Zealand - is an internationally respected biochemist, winner of the Royal Society of New Zealand's top science honour - the 2010 Rutherford Medal, and was also named a Companion of the New Zealand Order of Merit.

His honour citation noted that Professor Tate was a molecular biologist, whose research had "revolutionised understanding" of how proteins were synthesised in living cells. His research had shown how proteins contributed to memory formation and neurological disease, and had important implications for HIV, Alzheimer's and chronic fatigue syndrome.

Professor Tate is a Fellow of the Royal Society of New Zealand and of the New Zealand Institute of Chemistry.
He has been a Fellow of the Alexander von Humboldt Foundation of Germany, and an International Research Scholar of the Howard Hughes Medical Institute of the United States.

Department of Biochemistry University of Otago, New Zealand

Genetics Otago

Tackling ME/CFS in New Zealand by the Principals of Precision Medicine - Journal of IiMER Volume 10 Issue 2016

Source: http://investinme.eu/IIMEC12-news-170204.shtml

 

[Kenny Banya]

Why does the UK have to undertake a Phase III trial when the results are available from Norway?
This comes across as a stalling tactic

 

[helperofearth123]

Why does the UK have to undertake a Phase III trial when the results are available from Norway?
This comes across as a stalling tactic

From my understanding typically at least 2 Phase III trials are needed for the evidence that a drug works to be strong enough for it to become available on the NHS. It's because the trial needs replicating to see if it still has the same effects when performed by different scientists in a different place etc. So it's to make the evidence stronger and is standard practice in drug trials.

Personally I plan on flying straight to Norway for private treatment if the trial is positive enough.

 

[Jo Best]

Why does the UK have to undertake a Phase III trial when the results are available from Norway?
This comes across as a stalling tactic

From my understanding typically at least 2 Phase III trials are needed for the evidence that a drug works to be strong enough for it to become available on the NHS. It's because the trial needs replicating to see if it still has the same effects when performed by different scientists in a different place etc. So it's to make the evidence stronger and is standard practice in drug trials.

Also bearing in mind that the UK trial, including the preliminary B-cell research, has been instigated and funded independently of the official medical research bodies, by patients/parents via the charity Invest in ME Research.

 

[Jo Best]

Just for info, today marks the official launch of the Quadram Institute website, and the transitioning of the Institute of Food Research to become Quadram Institute Bioscience. This is their new page on the January 2017 public talks:
https://quadram.ac.uk/mecfs-talks-held-in-norwich/

 

[MEMum]

From my understanding typically at least 2 Phase III trials are needed for the evidence that a drug works to be strong enough for it to become available on the NHS. It's because the trial needs replicating to see if it still has the same effects when performed by different scientists in a different place etc. So it's to make the evidence stronger and is standard practice in drug trials.

Personally I plan on flying straight to Norway for private treatment if the trial is positive enough.

We'll see you there.

 

[Kenny Banya]

It's because the trial needs replicating to see if it still has the same effects when performed by different scientists in a different place etc.

That is weak reasoning.
"Sorry, you Norwegians aren't as intelligent as us English, so we can't trust your work"....
"Sorry, 150 subjects aren't enough for us. 300 is the bare minimum. Yes, we know mathematically that the difference between 300 & 150 for statistical analysis is negligible but, you know, can never be too sure!"
etc, etc, etc.....

 

[helperofearth123]

That is weak reasoning.
"Sorry, you Norwegians aren't as intelligent as us English, so we can't trust your work"....
"Sorry, 150 subjects aren't enough for us. 300 is the bare minimum. Yes, we know mathematically that the difference between 300 & 150 for statistical analysis is negligible but, you know, can never be too sure!"
etc, etc, etc.....

Science is based on repeatable observations.

https://en.wikipedia.org/wiki/Reproducibility
"Reproducibility is the ability of an entire analysis of an experiment or study to be duplicated, either by the same researcher or by someone else working independently, whereas reproducing an experiment is called replicating it.[1] Reproducibility and replicability together are among the main principles of the scientific method."

 

[Kenny Banya]

Science is based on repeatable observations.

https://en.wikipedia.org/wiki/Reproducibility
"Reproducibility is the ability of an entire analysis of an experiment or study to be duplicated, either by the same researcher or by someone else working independently, whereas reproducing an experiment is called replicating it.[1] Reproducibility and replicability together are among the main principles of the scientific method."

Then let's have 10 trials. Increases the confidence levels

 

[AndyPR]

Then let's have 10 trials. Increases the confidence levels

Yes, ideally that is what would happen. And in the UK we already know that NICE give more weight to research that has been done in the UK. So there are multiple reasons to attempt to replicate the trial in the UK as long as the results are positive. I can completely understand your frustrations, I too would like to be cured now, but good science takes time.

 

[deleder2k]

Sources speak of a rituximab + cyclophosphamide trial. I don't know when, but I imagine it won't take forever before we hear something more. I can't verify the information, but it should be the case. If I turn out to be wrong, please do not label me as fake news or fire me

 

[BurnA]

Sources speak of a rituximab + cyclophosphamide trial. I don't know when, but I imagine it won't take forever before we hear something more. I can't verify the information, but it should be the case. If I turn out to be wrong, please do not label me as fake news or fire me

Interesting! I wonder if anyone will let anything slip at iime.

If its true it implies positive results for cycloME (to some extent at least )

 

[Kenny Banya]

Yes, ideally that is what would happen. And in the UK we already know that NICE give more weight to research that has been done in the UK. So there are multiple reasons to attempt to replicate the trial in the UK as long as the results are positive. I can completely understand your frustrations, I too would like to be cured now, but good science takes time.

No, it creates unnecessary roadblocks.
The quality of the Norwegian trial (if done properly - database can be released, methods are in the paper) is sufficient for application anywhere.