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Lessons from ME/CFS: Finding Meaning in the Suffering
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What is the ME Association doing about Rituximab? Statement 8 July 2013

Discussion in 'General ME/CFS News' started by Firestormm, Jul 8, 2013.

  1. Firestormm

    Firestormm Senior Member

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    lilpink that was from Jo Best? Sorry I am just looking where it was posted and assume that is the case. Is she writing on behalf of IiME? I presume so but you don't say and I can't seem to determine. I won't post Dr Shepherds reply here in full. The exchange is all on Facebook for all to see just look for the title 'MEA pledge £50,000 for UK Rituximab Trial' and scroll through all the comments. Facebook is such a pain in the arse.
  2. lilpink

    lilpink

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    No I don't say. It's simply setting out how things are.
  3. Firestormm

    Firestormm Senior Member

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    Moving on. Do you think that IiME will meet with the other interested charities and get together round a table? I mean if others are able to pledge funds now we could reach that target a lot quicker than with public donations alone. Some research charities do for example have funds pending projects. Any thoughts?
  4. Dolphin

    Dolphin Senior Member

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    Here's Charles Shepherd's reply:


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  5. Bob

    Bob

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    I'm not interested in any bickering. IiME have made it clear that they have been organising a trial, and fundraising, for which I am very grateful. And the MEA have made it clear that they have a pot of money which they will make available if the trial's protocol passes its peer review procedures, for which I'm also grateful. It's seems that, not only are they both working towards the same aim, but the MEA is more than happy with the arrangements of the trial so far. If Stephen Holgate can manage to get some MRC funding fast tracked, at any stage, then so much the better.
    ukxmrv, Valentijn, Sasha and 3 others like this.
  6. Dolphin

    Dolphin Senior Member

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    Two advantages of MRC part-funding come to mind:
    (i) It would give the trial more status

    (II) It would save a lot of research charity money that could be used for other research.
    ukxmrv, Svenja, Valentijn and 2 others like this.
  7. Firestormm

    Firestormm Senior Member

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    Yes. This second point is something that is important. It's a lot of money we are talking about and our charities are not flush with cash - hence I suppose the small scale studies generally seen in the past.

    More collaboration is the key to future success.
  8. Bob

    Bob

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    Charities can't fund large scale medical trial to the tune of millions, so the MRC will have to get involved at some point if a large scale trial is ever to take place. Charity money is best used for seed money, IMO, to fund preliminary activities or small scale trials which are then used as proof of concept, or proof of safety, to apply for larger grants. I think it's questionable if private/charity money will stretch to the £400,000 needed for a 30 person trial, and some other funding may be required.
  9. Sasha

    Sasha Fine, thank you

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    Maria Gjerpe repeatedly made the point that one of the main reasons that she believed her MEandYou campaign was so successful was that she made it fun and positive - something that people would enjoy joining in with, something with a big 'feelgood' factor. She never deviated from that.

    I think we can really learn a lot from that. I want this trial to be funded, and quickly. Let's please not drive people away by conflict and criticism over issues that are infinitely less important than the trial getting funded. We need to encourage our charities to work together, to co-fund, and use their various contacts and networks and spheres of influence and get this thing funded, fast. Together, we're much, much stronger.
    Blue, ukxmrv, Svenja and 4 others like this.
  10. lilpink

    lilpink

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    Permission to Repost:

    The UK Rituximab Trial for ME

    Professor Malcolm Hooper Margaret Williams

    2nd August 2013


    The charity Invest in ME has provided a truly remarkable opportunity to address one of the biggest medical scandals in history and to remove what in 2007 Alex Fergusson, Presiding Officer (Speaker) of the Scottish Parliament, referred to as “the cold grip of psychiatry” on myalgic encephalomyelitis (ME), which he said was “still far too deeply rooted in the world of ME” (http://www.meactionuk.org.uk/Defiance_of_Science.htm).

    Now, however, despite the power and control of the psychiatric lobby, thanks to Invest in ME and the invaluable support of Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine at University College, London, (world-renowned for his work in B cell immunology and as lead researcher in the clinical trials of rituximab for rheumatoid arthritis), the neuro-immune disease ME is at last about to enter the realm of mainstream medicine in the UK under the guidance of Professor Edwards himself.

    Invest in ME are at the forefront of international biomedical research and have by sheer determination and effort managed to put things in place for a trial of rituximab to begin on ME patients in the UK. They recognise the urgency of the situation and know that many ME patients do not have the luxury of time. The charity already has the facilities in place, including suitably experienced researchers (Professor Jo Cambridge is now principal researcher at UCL, and the ME trial will involve the same team working under her that carried out the rituximab research in RA).

    The Clinical Trials Unit at UCL is already working on the protocol, and Invest in ME have agreed with Professor Edwards that the protocol will be externally reviewed even though the UCL team will make sure it is cast-iron by their own internal reviewers.

    Invest in ME have been told this trial could start relatively quickly if the charity had funds available. Such an opportunity must not be lost. However, this will not happen without substantial funding.

    We therefore ask everyone who is able to do so to donate whatever they can afford, in order that the UK rituximab trial can get under way as quickly as possible whilst the excellent facilities and committed staff at UCL and the active support of Professor Edwards remain available, so that ME can finally be recognised as the devastating multi-system neuro-immune disease that it is and – most importantly -- so that sufferers may at last have some hope of alleviation of their suffering.

    Invest in ME have assured us that all donations to the rituximab fund will sit in a separate account which is totally ring-fenced, and should the trial not proceed, the following statement on the IiME website will be honoured –

    What Happens With These Funds If The Project Does Not Go Ahead:
    If the rituximab project does not go ahead for some reason then the funds raised will be transferred to the IiME Biomedical Research Fund to fund other biomedical research projects which are attached to our proposal for an examination and research facility based in Norwich Research park in Norfolk, UK. These funds will only be used for biomedical research into ME.
    - http://www.investinme.org/IIME Statement 1306-01-faq.htm

    A UK trial of rituximab is essential to move ME out of the realm of psychiatric dogma and into the realm of medical reality.

    Information on how to donate can be found on the Invest in ME website: www.investinme.org
    sproggle likes this.
  11. Sasha

    Sasha Fine, thank you

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  12. Bob

    Bob

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    I appreciate the enthusiasm from Hooper and Williams, but I think we all need to be careful to also express caution, perhaps especially when fundraising. I don't want to bring negative energy to the issue, but I do suggest that we don't over-play expectations. We've all been here before: Massive expectations with no guaranteed outcome. And if it ends without the result we want, many people might understandably find it difficult to deal with. It might be the case that Rituximab doesn't lead us anywhere meaningful. But even if 10% of patients experience a dramatic recovery, the NHS probably wouldn't approve the drug, because of its safety profile and its expense. So we should perhaps prepare ourselves for a long and bumpy road.

    Edit: I'm not suggesting that people shouldn't donate. I think it's a very important trial, and it has the potential to transform the field of ME. But I think that people should be aware that the results from Norway do not suggest that a majority of patients will experience dramatic improvements, as far a as I understand the results.
  13. biophile

    biophile Places I'd rather be.

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    Amen brother!
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  14. dasiymay

    dasiymay Senior Member

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    Professor Edwards, thank you so very much for getting involved with this ME research, really appreciated.
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  15. Legendrew

    Legendrew Content team

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    I agree entirely - this trial needs doing to test whether the response is the same as has been shown in the Norway trials however they didn't show 100% improvement/recovery so while I expect some ok results from the trial we really need to wait and see before getting excited about this. Hopefully the results lead to more trials in different drugs/biomedical research
    Bob likes this.
  16. Sasha

    Sasha Fine, thank you

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    Important not to underplay either, Bob! :)

    I don't think we have been here before - well conducted, placebo-controlled RCT; better results in a follow-up building on the previous work, as has been stated publicly (though the detail is still embargoed) by Fluge & Mella at the IiME conference; 67% of patients getting moderate to major improvement (vs 15% controls, and if memory serves, the only two non-CCC-defined participants); many other charities acknowledging the plausibility of the hypothesis and wanting to do their own trials; some patients in full remission, which has held up for up to four years now for some. We haven't seen this.

    The work is in its early stages and dosing and co-therapy (e.g. with Valcyte) is something that people are looking at. The percentage of patients getting major benefit is likely to increase (it sounds as though perhaps it already has).

    By the time the NHS will be looking at this we'll have more data on who the drug works for and its safety and efficacy for ME. At that point, it will be time for patients to pile on and demand it, if we need to. People with rheumatoid arthritis and other conditions get Rituximab; our disease is no less disabling and with data behind us from RCTs we'll be well-placed to campaign if we need to. Personally, I expect the NHS to cough up.

    And regardless of the scale of benefits, just confirming that an immune therapy works for some ME patients benefits us all - validates our disease as an immune disease, gets us social recognition, gets a better attitude from our doctors and opens the floodgates to more research.

    There's every reason to feel excited about this, I think - and I think we have to keep these reasons in mind.

    And, of course, donate! :)
    Purple, user9876 and Kate_UK like this.
  17. Bob

    Bob

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    Edit: There are many errors in this post, so please don't rely on it (I won't delete it because it's part of the later discussions.) (Corrections are pointed out in the discussions below.)


    I just had another look at Fluge and Mella's 2011 paper, to see if I'd interpreted it wrongly.
    (I haven't seen the results of their unpublished latest study.)

    When compared to the placebo group, 8 out of 15 (53%) extra patients responded to treatment. These were all defined as a 'major' response to treatment. The average response duration was 25 weeks.

    However, I am unable to work out exactly what a 'major' response meant, as their primary outcome scale is an average of four other outcome scales, and I can't find how they calculated their scores.

    A 'major' response was defined as a Fatigue score ≥4.5 for at least six consecutive weeks ("also demanding recordings of some fatigue symptoms as major improvement (value 6) during the response period"), but I can't find the Fatigue scores at baseline for comparison, and I can't work out what a Fatigue score of 4.5 actually means, in terms of function.

    I don't fully understand the way results have been presented, but a brief calculation suggests to me that average SF-36 physical function scores increased as follows...

    Average SF-36 physical function scores in treatment group:
    Baseline = 34 points
    change (increase) = 13 points after treatment (this is the average maximum increase in scores)
    End = 47 points

    Or, if taking the placebo group into account the changes are as follows, for the treatment group:
    Baseline = 34 points
    change (increase) = 4 points as a result of placebo
    End, after increase as a result of placebo = 38 points (when improvements as a result of placebo are added)
    change (increase) = 9 points as a result of treatment *
    End = 47 points

    * This compares with an increase of 9.4 points for GET in the PACE trial.

    Edit: This isn't an appropriate comparison. See posts below for details.

    (I might have got my calculations wrong)



    There are 3 or 4 patients in full remission, as far as I understand (but I might have this wrong), and I thought there was talk about the effects not being long lasting in all the patients who experienced full remission (again, I might have this wrong). These are certainly promising results, but 3 out of 30 patients in full remission means that 90% (27 out of 30) of patients are potentially going to be disappointed.

    Edit:
    There are 3 or 4 patients in full remission, as far as I understand (but I might have this wrong). These are promising results.
    But 3 out of 15 patients in full remission means that 80% (12 out of 15) of patients are potentially going to be disappointed.



    I'm still trying to make sense of the paper, but if anyone can explain what I've not understood, then I'd be grateful.

    Full paper:
    http://www.plosone.org/article/info:doi/10.1371/journal.pone.0026358
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  18. Dolphin

    Dolphin Senior Member

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    They used normalised scoring for the SF36 PF. So can't compare directly to PACE Trial.

    They also looked at peak value obtained, as I recall.
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  19. Bob

    Bob

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    Thanks Dolphin. Do you mean SF-36 v2, or something else?

    Yes, they looked at (average) peak, or maximum, improvements, so it's not directly comparable to the PACE results.
  20. Sasha

    Sasha Fine, thank you

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    I don't have time to re-read the paper just now, Bob - someone else will have to pick this one up - but just wanted to say that I think you're setting the bar extremely high if you're saying that patients who don't get a full remission - full remission! - will be disappointed. Frankly, at this point, I'd be thrilled with an increase in function of ten percentage points. It would transform my life.

    Thanks for raising these issues, though. If you've got these questions, others will and it will be useful to discuss it. I just think it's important not to get sucked into the mindset of 'it's not perfect so it's not good enough'. I understand, of course, the years of frustration that people have and our wish for a return to health. But getting there is going to be a series of research steps and this is a very important one to take.

    But I think we both agree that we should all donate! :)
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