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9th Invest in ME International ME Conference, 2014 - Part 1: Autoimmunity and ME
Mark Berry begins a series of articles on the 9th Invest in ME International ME Conference in London, with a look at three presentations on autoimmunity
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Haukeland Rituximab follow-up study, 21 July 2013: "even higher rates of effect"

Discussion in 'Latest ME/CFS Research' started by Sasha, Jul 22, 2013.

  1. Sasha

    Sasha Fine, thank you

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    Just received this from Co-cure: presumably it's in relation to the work presented by Fluge & Mella at the London Invest in ME conference. I don't know to what extent the embargo is still in operation but presumably the info in this report has come from a press release - it's only at a very general level though and I think we should assume the embargo on any detail is still on until we hear otherwise.

    My bolding.

    Note: To turn on English subtitles in the video click the 'cc' button​
    at the bottom of the player [that's the rectangular button to the left of the little cogwheel thing that only appear once you start playing the clip].​

    ----------------------------------------------------------​


    News on TV2: Rituximab at Haukeland Hospital and MEandYou gives away 3​
    million NOK!​

    This is the translated text and the subtiteled video from the TV2-news​
    from 21.07.13.​

    ENGLISH:​
    Two years ago, two scientists at Haukeland University Hospital​
    published a medical breakthrough suggesting that ME may be an immune​
    disease.​

    Now they are ready with a new folllow-up trial that shows even higher
    rates of effect – and they also get up to 17 million to make a huge
    survey and that should provide the definitive answer to the disease.

    Medical doctor and ME-patient, Maria Gjerpe, presents nearly 3 million​
    collected money (through MEandYou) for the researchers at Haukeland.​
    Two years after they published sensational research suggesting that ME​
    is an immune disease, they have received a total of 17 of the 22​
    million they need – enough to investigate further.​

    Olav Mella: – These funds are vital for us to conduct a larger study​
    of 140 patients to confirm or deny the results of our two previous​
    studies.​

    Cause Olav Mella and Øystein Fluge has just crossed the finish line
    with a new study that confirms the first. They have also increased
    medication doses and build a more prolonged effect.

    Mella: - A new study that we just are trying to make up shows that we​
    can achieve a significant prolonged improvement of symptoms if we give​
    multiple infusions.​

    But a much larger study is still essential before one can possibly​
    offer treatment. And it is hugely important for a patient group, many​
    have not only been extremely ill, but also have felt suspected and has​
    been labeled as mentally ill.​

    Gjerpe: - The patient group is very hopeful regarding what takes place​
    at Haukeland Hospital. This is the closest we have ever been in​
    relation to find a treatment and to understand the disease mechanisms.​

    Now, a patient group that counts several millions worldwide hope that​
    they can be just as healthy as the Norwegian pilot patients went. But​
    in some places they do not want to wait for the research.​

    Cherry Cordova is on the way to her doctor in Silicon Valley. It began​
    many years ago when Cherry, who is a researcher, attended an IT​
    conference in Madrid. There, she caught something that felt like​
    influenza.​

    Cordova: – It took about ten years before the body temperature dropped​
    to normal levels.​

    At Dr. Andy Kogelniks clinic in California she gets treatment for ME​
    with a type of medicine that actually usually are used to treat severe​
    cancer.​

    Kogelnik: - I would argue that a neuroimmune disease is a very serious
    disease, and if I had two pick, I would probably rather have cancer.

    It was the doctors Øystein Fluge and Olav Mella of Haukeland Hospital​
    who by chance discovered that this medicine also appeared to be work​
    in chronic fatigue syndrome.​

    Kogelnik: - It is obviously something which takes them from a very low​
    level of functioning and raises many of them, certainly not all, on a​
    much higher level of functioning.​

    Andy Kogelnik heard about the Norwegian method of treatment that​
    affects the immune system and now he has given it to about 40​
    patients, including Norwegians, who travel to California to be​
    treated.​

    Cordova: -It felt like a switch had flipped in my head, and I can​
    think clearly again. I am somebody that rather would try something,​
    even if there is some risk, and the benefits certainly outweigh the​
    risks for me. Thinking that maybe I can get some of my life back.​
  2. Sasha

    Sasha Fine, thank you

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    I'm assuming, by the way, that there might still be an embargo on the detail of this - the Invest in ME conference organisers were, I think, holding back the Fluge & Mella presentation from their DVD of the conference, which is being mailed out this week. We should all respect the embargo. We don't want to do anything that would affect their chances of publication.
    Sean, peggy-sue, Bob and 1 other person like this.
  3. Firestormm

    Firestormm Guest

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    I am still struggling with the funding, Sasha. Has the Norwegian Govt. finally then stomped up the 17 million (what's that in 'real' money btw ;))?

    We were I thought waiting for the actual amount to be revealed; maybe this is that announcement? So, 17+3 = 20 meaning they are 2 million short? :confused:

    Thanks in advance :)
  4. Sasha

    Sasha Fine, thank you

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    Your guess is as good as mine there - I haven't heard any news of a formal announcement of funding by the Norwegian government and 'up to 17 million' isn't the same as '17 million'.
    Firestormm likes this.
  5. Bob

    Bob

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    Thanks Sasha. Yes, we should assume that the embargo is still active until the paper is published. I don't know the results but it seems clear, from all accounts, that they are just as promising as the initial trial.

    Firestormm, I haven't heard about the funding yet either. I don't know why we haven't heard.
    Firestormm likes this.
  6. jeffrez

    jeffrez Senior Member

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    Sorry to be so cynical, but my thought is that of course their results look "promising" -- they're getting $17 million! Correct me if I'm wrong, but isn't it true that the results of people getting ritux in the US and elsewhere haven't been so good? After they get their $17 million and the results are "promising" but no one really gets better from it, then what? I'll wait to see consistent, real world results before getting my hopes up.
  7. Firestormm

    Firestormm Guest

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    It's 17 rising to 22 million Norwegian Kroner from what I understand. So a little under $4 million US. If I have my calculations right - which I probably don't today :)

    I agree with you. I think the andecdotal reports from those being treated outside of trials is of concern. However, I really would like to see these latest trial results as and when they have dotted the i's and crossed the t's - or whatever the heck the problem is with publishing them. I can never understand why they announce at conferences open to the public and then insist on an embargo. Just seems wrong to me somehow. Will have to wait I guess.
    jeffrez and Bob like this.
  8. Bob

    Bob

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    I agree that it's important not to expect Rituximab to be a cure-all.
    When I inspected the results in the original Rituximab paper, I was totally under-whelmed, and disappointed, and I couldn't see what all the fuss was about.
    But, from hearing other reports about the trial, it seems that some patients (maybe one or two?) experienced a drastic turn-around in their health.
    But do we know how many responded this well?
    And how many responded to such a degree that we would all be really happy about if it happened to us?

    My own interpretation of the results suggested that they weren't very good.
    So either I misinterpreted the results, or they weren't presented well, or they were disappointing. I can't work out which.

    And do we know if the patients were a specific type of patient with specific or unusual symptoms?
    As usual with these sorts of studies, it's far too early to tell what's going to happen.
    I don't think we should place all of our eggs and expectations into the Rituximab basket.
    Or I can't help feeling that many of us are going to be disappointed.
    I'm watching out for the results with an open mind, but cautiously hopeful.

    But there is a lot of other amazing and promising research going on as well, at the moment.
    Any of it could lead to some important discoveries.
    MeSci, Firestormm, peggy-sue and 2 others like this.
  9. urbantravels

    urbantravels disjecta membra

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    I'll take a well-designed, well-controlled, published and peer-reviewed study over isolated anecdotal reports any day of the week, and twice on Sundays.

    Crucial translation issue alert!

    "Just trying to make up" a study is completely meaningless in English, so what did he really say? Trying to publish? But if it's already being published, then what IS he talking about??

    Talking so freely about a new, as yet unpublished trial TO THE PRESS is very different from discussing such a study at a meeting or conference. I don't see how they could possibly be doing that unless publication is really imminent. But maybe I'm missing something due to translation issues.
    Firestormm and SOC like this.
  10. Valentijn

    Valentijn Activity Level: 3

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    The journals probably refuse to accept studies that are already published. Hence they can talk about them a bit in a somewhat private setting, but probably can't make any on-the-record official comments.
    Firestormm likes this.
  11. Bob

    Bob

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    Regarding not being able to discuss unpublished results...

    I think it's all to do with protecting private profits and private interests.
    If the results are made public elsewhere, then people would be less inclined to pay to access the journal.
    If results were generally made available elsewhere, then journals would become redundant.
    SOC, Valentijn and Firestormm like this.
  12. Legendrew

    Legendrew Content team

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    You have to remember though that the only trials published on this are from Norway so far. The anecdotal evidence is not something medicine looks at seriously. The reason the anecdotal evidence is likely not as promising is probably down to the sub-grouping of ME patients. The people in these rituximab trials have been thoroughly tested for any other illness or diseases leaving only verified CFS/ME patients in the trial (I'd be willing to bet that very few ME patients have undergone such intense testing). As much as it hurts me to say this, some people in America and across the world are rushing into getting Rituximab treatments before the trials are complete, and in the process may not even have ME/CFS to start with - or may have a different illness that's currently catagorised as ME/CFS but has a completely different cause (from reading a few forums/blogs it seems many with pain as a predominant symptom seem to be responding badly.) These things take time unfortunately, but for now base your opinions on the published data and not one off reports. I think the picture will get a lot clearer about this drug once more trials start. Positive trials can only mean good news though, even if Rituximab proves to be less effective than thought, it's clearly changed the research direction for the better.
    MeSci, Tally, Little Bluestem and 3 others like this.
  13. urbantravels

    urbantravels disjecta membra

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    I think Legendrew makes good points. Besides that, one-off anecdotal experiences have extremely limited usefulness. They may suggest questions to be addressed later in proper studies, but they can never lead to any kind of conclusion on their own. This is especially true in a relapsing/remitting condition that fluctuates all the time anyway. You will never be able to pick out the effects of treatment from the baseline condition in one individual, because you have no way of knowing what the baseline condition would have been without the treatment. That's why you need larger groups, as similar as possible, undergoing the same treatment under the same conditions at the same time. This is how you correct for variations in the baseline condition.
    SOC likes this.
  14. Bob

    Bob

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    I think you make some useful points here, but where you say: "The reason the anecdotal evidence is likely not as promising is probably down to the sub-grouping of ME patients", I think we need to remember that the original trial results were not overwhelmingly positive.

    My own interpretation of the results (which might be an incorrect interpretation) was that they were disappointing. So, based on the trial results, I think it would be expected that many CFS/ME patients wouldn't respond well to Rituximab.

    My interpretation of the results might be wrong, but I've studied the paper a number of times, and each time I've looked at it, I couldn't work out what all the fuss is about.
    Legendrew and jeffrez like this.
  15. Legendrew

    Legendrew Content team

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    The original 3 person data looked very promising and i think that the 30 person trial only looked disappointing in comparison to this - especially disappointing were the longer time to response and shorter remission period but these strike me as things that would be effected by altering dosage and reapplication of the therapy. It is true though that the 30 person trial was initially something of a failure but this is more from the primary end-point they put in place - expecting immediate results as seen in the three person trial but upon moving this to a few months later the results were not too shabby. 67% response (whether that be back to normal health or at least increased functioning) is something that deserves more attention

    You make a very good point though that this treatment may not be tolerated well by some people which gives even more reasoning into finding sub-types (whether they be genetically based or immune/non-immune/immune deficient as has been suggested) that respond better or worse to the therapy. There's no escaping that this is a serious therapy and we need a way to ensure it's given to people with a good chance of success to outweigh the side effects. The last thing chronically ill people like us need is something to make us even worse.

    Andrew (19)
  16. jeffrez

    jeffrez Senior Member

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    See, I think you undercut your own earlier argument here, b/c the original 3 people had cancer! So that is not a valid CFS cohort by any means, imo. And the follow-up showed only mediocre results, as Bob has said. I agree that the fact that some people seemed to respond at all gives some promise of hope, but we are a long way from sorting all that out, I think. Nothing is clear cut yet, to my thinking. I'll wait to see more evidence, both investigative and clinical (which we're wrong to dismiss completely out of hand as merely anecdotal, imho).
    Legendrew and Bob like this.
  17. Legendrew

    Legendrew Content team

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    Hopefully more data doesn't take too long to get here, as with everything replication of the data, however people interpret it, is crucial! My original point was simply to not put too much weight on the non-trial data - whether it be positive or negative.
    It's interesting how much debate and discussion topics like this bring up. I think the XMRV affair seems to have taught people to not get carried away with these things until all the data is there.
    Bob likes this.
  18. Forbin

    Forbin Forbin

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    The practice actually has a name. It's called the "Ingelfinger Rule."

    It has its critics, but one interesting rationale is that it is supposed to combat "science by press conference" (not waiting for peer review).

    http://en.wikipedia.org/wiki/Ingelfinger_rule

    http://en.wikipedia.org/wiki/Franz_J._Ingelfinger
  19. Bob

    Bob

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    Someone posted this video on another thread, and I hadn't seen it before.
    It explains some of the Rituximab results, and it interviews the 2 or 3 patients who experienced dramatic recoveries.
    It's clearly these 'recovered' patients that have captured the attention of the media etc.
    It also says that a third of 33 patients, in the trial, didn't respond.

    It's got English subtitles, but you might have to select them to switch them on...

    www.youtube.com/watch?feature=player_embedded&v=ZBCXKIRBQ-s

    RL_sparky likes this.
  20. liquid sky

    liquid sky Senior Member

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    They really need to study immune responses to the rituximab. They need good baseline tests of immune function and then what exactly changes in those who respond and those who do not. Hopefully, they can tease out some cohorts and also what type immune dysfunction responds to rituximab.

    If they can decipher what immune signatures respond, then they can spare those patients who will not respond from exposure to the drug. This is not a harmless drug and they are talking about using it repeatedly for possibly years.
    Firestormm, Valentijn and Bob like this.

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