Big thanks to Maria indeed, for showing them how much public support there really is!
Good news! Norwegian govt funds Rituximab trial - possibly partial, amount not yet announced
- Thread starter Sasha
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Here's a history article showing the various drugs under development, from 2010:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2805725/
"Anti-CD20 monoclonal antibodies: historical and future perspective"
Humax (fully human, no rodent component) is probably farthest along but I haven't checked.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2805725/
"Anti-CD20 monoclonal antibodies: historical and future perspective"
Humax (fully human, no rodent component) is probably farthest along but I haven't checked.
I think they were working on an injectable version which would make giving the drug easier
http://www.roche.com/media/media_releases/med-cor-2012-12-08b.htm
http://www.roche.com/media/media_releases/med-cor-2012-12-08b.htm
Thanks for posting that, I hadn't seen that the results were in. I expect that in the U.S., there will be resistance because infusion centers are significant moneymakers.
is the person in this piece (very skeptical of Ritux for CFS) a forum member ? http://www.sciencebasedmedicine.org/index.php/rituximab-for-chronic-fatigue-syndrome-jumping-the-g/
Forget it, Jake. It's Science Based Medicine. They like all science except that which relates to ME/CFS, which to them is Bad Science.
ok, Im new to this game and haven't encountered them before 
Morning Ether
We had a productive and frank debate about this opinion-piece on this thread following it's publication. Hopefully, when the Norwegians get their follow-up study underway, along with OMI-MERIT's, and the results come back; these will better explain if Rituximab works, how it works, and who in our population it is most likely to work on. Be nice to think that if it does support the initial study; they can also then develop a specific test that confirms suitability prior to prescription; and that it all serves to make the drug more affordable.
We had a productive and frank debate about this opinion-piece on this thread following it's publication. Hopefully, when the Norwegians get their follow-up study underway, along with OMI-MERIT's, and the results come back; these will better explain if Rituximab works, how it works, and who in our population it is most likely to work on. Be nice to think that if it does support the initial study; they can also then develop a specific test that confirms suitability prior to prescription; and that it all serves to make the drug more affordable.
I wouldn't say that, but they are generally the most skeptical about any "scientific" finding there is. Eg they're skeptical about psychiatry etc. in general too.
This drug is very dangerous and toxic. It is very important to find which patiënts will benefit with objective markers. I think ”only” 30% will benefit from this medicine. I am a little sceptical because ME is primary not an auto-immmune disease. If you read the papers it does not fit. There is more. But time will tell us. I hope no patients will be dead after using Rituximab. Maybe it will turnout like the XMRV story.... I hope i am wrong....
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Hmm well as has been pointed out earlier, even 30% is an amazing achievement.
Not only will it restore very sick patients back to full health, but it will also represent a huge advance in medical knowledge of ME/CFS, and provide a point of reference for all future research.
That doesn't mean that you are wrong, but I don't think we should be so pessimistic. Perhaps a bit of cynicism is warranted - to protect ourselves from possible disappointment - but on the whole I think the funding of future Rituximab trial is very much to be welcomed.
Not only will it restore very sick patients back to full health, but it will also represent a huge advance in medical knowledge of ME/CFS, and provide a point of reference for all future research.
That doesn't mean that you are wrong, but I don't think we should be so pessimistic. Perhaps a bit of cynicism is warranted - to protect ourselves from possible disappointment - but on the whole I think the funding of future Rituximab trial is very much to be welcomed.
I dont know that I would say it is "very dangerous"...potentially very dangerous, yes. But plenty of people have it without big problems. It is not a mild treatment that I can agree on and I think we need to know for sure if it works which is why these studies are so important. Hopefully we can quickly understand who it works for and who not, but some people do appear to have a dramatic effect from it, so it seems to me that its worth some risk in trying it, even if we cant figure out who it will work for in advance, for some time.
I think a lot of us would take a drug like this for a 30% chance of a pretty full recovery, and a managed risk of damage or death that was balanced appropriately against this potential benefit. Its the same decision that people have to make who take the drug for other conditions already, though of course they are further along the curve and have more data to base decisions on.
I personally think the results so far show a greater than 30% chance of sucess anyway, but of course, it is early days - the next study could change that, positive or negative.
Whether ME is an autoimmune condition or not, is a matter for debate. I dont think we can say that "ME is primary not an auto-immmune disease" anymore than I can say "ME is primary an auto-immmune disease" - its a matter of opinion at the moment. Personally, I think there is a good chance that it is an auto-immune disease and there is some evidence to back that up, but its not enough to draw conclusions from, so we will have to wait and see.
Rituximab may or may not work out, but it has already got a better chance than XMRV did because XMRV was a very different subject - It was thought to be a novel human infecting pathogen causing a disease. This is an existing drug treatment that works in order diseases, that we know is real, and that we already have informaiton on and use in other patients with other diseases, and the question is whether it will work in ME patients. It could still turn out not to work in us patients, which would be a fail, but thats still very different to XMRV. The similarity, I think, is that the patient community is very interested in it, it has the potential to be a game changer, but thats about where the similarities end; they're apples and pears...or maybe blueberries and water melons?
I think a lot of us would take a drug like this for a 30% chance of a pretty full recovery, and a managed risk of damage or death that was balanced appropriately against this potential benefit. Its the same decision that people have to make who take the drug for other conditions already, though of course they are further along the curve and have more data to base decisions on.
I personally think the results so far show a greater than 30% chance of sucess anyway, but of course, it is early days - the next study could change that, positive or negative.
Whether ME is an autoimmune condition or not, is a matter for debate. I dont think we can say that "ME is primary not an auto-immmune disease" anymore than I can say "ME is primary an auto-immmune disease" - its a matter of opinion at the moment. Personally, I think there is a good chance that it is an auto-immune disease and there is some evidence to back that up, but its not enough to draw conclusions from, so we will have to wait and see.
Rituximab may or may not work out, but it has already got a better chance than XMRV did because XMRV was a very different subject - It was thought to be a novel human infecting pathogen causing a disease. This is an existing drug treatment that works in order diseases, that we know is real, and that we already have informaiton on and use in other patients with other diseases, and the question is whether it will work in ME patients. It could still turn out not to work in us patients, which would be a fail, but thats still very different to XMRV. The similarity, I think, is that the patient community is very interested in it, it has the potential to be a game changer, but thats about where the similarities end; they're apples and pears...or maybe blueberries and water melons?
Rituximab needs to be researched, seeing as the results are promising, whatever the final outcome. And a lot of further research into similar, less dangerous, drugs might come off the back of the Rituximab research. And even if only, for instance, 20% of patients experience a dramatic improvement, this would probably hurl CFS research forwards with leaps and bounds, for various reasons. Other fields of research might suddenly start getting involved in CFS, just as they did after the XMRV research was published.
But I also wonder if it's too early to know if the improvements seen in the first trial were particularly impressive. A second, slightly larger, trial has been completed, so hopefully we'll see the results of that very soon.
With regards to severe side-effects, I read (in one of the recent IiME conference reports) that Rituximab might present a much smaller danger, to ME patients, of a severe reaction, than it does to cancer patients. I can't remember the reason why.
But I also wonder if it's too early to know if the improvements seen in the first trial were particularly impressive. A second, slightly larger, trial has been completed, so hopefully we'll see the results of that very soon.
With regards to severe side-effects, I read (in one of the recent IiME conference reports) that Rituximab might present a much smaller danger, to ME patients, of a severe reaction, than it does to cancer patients. I can't remember the reason why.
Here Bob, refresh me brain - what trial has been done that we haven't heard the results from yet? I feel like I'm on another planet at the moment. Thanks
I wonder what we might learn if the results of the next phase as not good. Would this mean a) ME is not an autoimmune condition; or b) that simply this drug is not good?
Probably (b). Although maybe (a). I can't offhand think of any research that specifically says patients with ME have similar issues with X cells as this other population who do have an autoimmune condition and are treated successfully with Rituximab.
Comparison studies would be cool I think.
I wonder what we might learn if the results of the next phase as not good. Would this mean a) ME is not an autoimmune condition; or b) that simply this drug is not good?
Probably (b). Although maybe (a). I can't offhand think of any research that specifically says patients with ME have similar issues with X cells as this other population who do have an autoimmune condition and are treated successfully with Rituximab.
Comparison studies would be cool I think.
Here Bob, refresh me brain - what trial has been done that we haven't heard the results from yet? I feel like I'm on another planet at the moment. Thanks
At the IiME conference, Fluge and Mella announced the results of a slightly larger follow-up Rituximab trial, but we're not allowed to know the results until they are published. All accounts suggest that the results are not disappointing.
I think negative results wouldn't tell us anything except that Rituximab doesn't work.
(As far as I know, not all immune conditions respond to Rituximab.)
Yes, it would be interesting to compare ME with any other diseases that respond to Rituximab.
(But apart from cancer, I don't know what conditions respond to Rituximab. Arthritis?)
But the response to Ritixuimab for different conditions might be a result of the drug having more than one mechanism, so it wouldn't mean that different diseases have the same cause or basis, just because they both respond to the same treatment.
For example MAOIs are anti-depressants, but they only discovered that they worked for depression when treating patients for an entirely different disease (I think it was tuberculosis). (The tuberculosis patients were experiencing an elevated mood when prescribed MAOIs.)
Thanks signore
Hopefully we won't have to wait too long for those results then and that (remember those criticisms?) they will have learned a thing or two from the experience. I can't think that the results will have been 'bad' or they wouldn't be off on the next step with such vigour.
I mean there's such enthusiasm from those two scientists and with the results they have had already behind them - I don't think we are looking at another XMRV here. Yes. I know. Firestormm putting a bet on this being of recognised significance! Who would have thought? From this skeptic of all people
I'm not too comfortable with prescribing this drug to patients now of course (for reasons we've discussed productively before); but I am about the science that I have read and understood. Lots of questions remain of course and the overriding one for me would be 'why?' Why does it work and why doesn't it work? Then of course you are into who will it work on and can we test in advance for these people?
There must be a process through which patients with e.g. Rheumatoid Arthritis are assessed as being likely candidates for the treatment. That's my assumption mind. There may not be. Could be a case of 'have the disease, get the treatment' if you can afford it of course.
I would be more comfortable if another group of scientists were conducting similar trials or looking at the mechanisms trying to discover the 'why?' but if this all pans out then they will follow. One thing I don't think will happen right away - Rituximab will not as a result of the next phase in Norway if successful - become a treatment on the NHS or a feature on NICE or the CDC.
Gods know how long that would all take. 10 years? 20? Wouldn't stop patients of course and physicians from prescribing privately. Anyway, interesting times my friend. Very interesting times. I wouldn't have it any other way
Hopefully we won't have to wait too long for those results then and that (remember those criticisms?) they will have learned a thing or two from the experience. I can't think that the results will have been 'bad' or they wouldn't be off on the next step with such vigour.
I mean there's such enthusiasm from those two scientists and with the results they have had already behind them - I don't think we are looking at another XMRV here. Yes. I know. Firestormm putting a bet on this being of recognised significance! Who would have thought? From this skeptic of all people
I'm not too comfortable with prescribing this drug to patients now of course (for reasons we've discussed productively before); but I am about the science that I have read and understood. Lots of questions remain of course and the overriding one for me would be 'why?' Why does it work and why doesn't it work? Then of course you are into who will it work on and can we test in advance for these people?
There must be a process through which patients with e.g. Rheumatoid Arthritis are assessed as being likely candidates for the treatment. That's my assumption mind. There may not be. Could be a case of 'have the disease, get the treatment' if you can afford it of course.
I would be more comfortable if another group of scientists were conducting similar trials or looking at the mechanisms trying to discover the 'why?' but if this all pans out then they will follow. One thing I don't think will happen right away - Rituximab will not as a result of the next phase in Norway if successful - become a treatment on the NHS or a feature on NICE or the CDC.
Gods know how long that would all take. 10 years? 20? Wouldn't stop patients of course and physicians from prescribing privately. Anyway, interesting times my friend. Very interesting times. I wouldn't have it any other way
I don't think the results can have been bad either, because two days after the results being presented, Invest in ME (the conference hosts) announced that they were starting a fund for a UK trial.
The Open Medicine Institute in the US have a $7.65 million Rituximab/Valcyte trial (singly and in combination) that they're seeking funding for. No-one is waiting for more results before committing - they're committed already, and trying to raise the funding.
Hey Sasha, do you happen to know how much they have raised? Only I checked their website the other day and it didn't seem to say much about it. Thanks
Hey Sasha, do you happen to know how much they have raised? Only I checked their website the other day and it didn't seem to say much about it. Thanks
Article coming up soon!
Edit: They're a bit slow to update their website. It's their Facebook page that keeps fairly current.