Despite Our Losses, People with ME/CFS Want More
We've been cheated by ME/CFS and we all know it. That's a no-brainer, if you'll pardon the cognitive pun. And loss didn't just result from the bad things that befell us. It also encompasses the good things that just ... never came. The absence of bounty. Of wholeness. Of peace.
Discuss the article on the Forums.

Rituximab Phase III - Negative result

Discussion in 'Latest ME/CFS Research' started by Marky90, Nov 21, 2017.

  1. Cinders66

    Cinders66 Senior Member

    Messages:
    427
    Likes:
    1,837
    This is sad news, some will really struggle with this news.

    I personally as severe wasn't expecting the drug to help me as this was something already suggested but we all hoped it would be the game changer and get at least some part of the puzzle fixed.

    What is the threshold for a negative result,
    I suppose it could still be helping some but 25 % wouldn't be enough?

    With what people think on subgroups maybe it's too much to expect a large percentage to improve with it.

    Utter blow though, the main treatment hope and a lot of money. I gave a lot to the trial. I don't regret it but now the mountain seems higher to climb.

    Thank heavens for the new research on energy coming through which, if it gets more funding for large trials can hopefully take off.

    Much thanks to the courage , commitment and honesty from Drs Fluge and Mella and I too hope they continue working in the field. Their metabolism research has been very important too. They must feel disappointed but we are so grateful they took on something few others would have.
     
    Mel9, Morrow, simeyss and 20 others like this.
  2. MEMum

    MEMum Senior Member

    Messages:
    439
    Likes:
    2,241

    From Prof Mella's talk in the summer at IiME (hope I got the right name) he seemed committed to keep trying with different meds. His comment, if I remember correctly was "It would be surprising if the first one or two immune modulators we tried are the ones that end up being the best for ME treatment". He certainly sounded optimistic (for a Norwegian! Don't get me wrong he's a lovely approachable guy as well as all his medical/research skills, but his manner is calm and composed.)

    I think that with all their substudies and evaluation of baseline data etc there will be some very useful information for researchers to work on, and fit more pieces into the puzzle that is ME
     
    justy, MandM, Vonjones and 21 others like this.
  3. ukxmrv

    ukxmrv Senior Member

    Messages:
    4,391
    Likes:
    4,552
    London
    I can feel a "thank you" card coming on. At the moment I need to sit in a corner and weep but a card will definitely be forthcoming in the future.
     
    fireflymd, justy, lemonworld and 26 others like this.
  4. Nickster

    Nickster Senior Member

    Messages:
    306
    Likes:
    2,399
    Los Angeles, CA
    This is so disappointing. I know this is how science works and we have to look at the truth of what can be used as treatments.

    I am so glad that we have many different scientists, doctors and patients trying to find the correct treatments. Glad that we have awareness to this disease and funding.

    Ron Davis talked about clinical trials for trying drugs and maybe that will be the golden ticket. He certainly knows a lot about this disease.
     
    TrixieStix, MEMum, simeyss and 5 others like this.
  5. Scarecrow

    Scarecrow Revolting Peasant

    Messages:
    1,904
    Likes:
    5,392
    Scotland
    @deleder2k I don't know if it's still not ok for you to comment on your own response until publication but I just want to say that I hope so much that you got a positive result.
     
    justy, aimossy, MEMum and 3 others like this.
  6. Ben H

    Ben H OMF Correspondent

    Messages:
    966
    Likes:
    10,745
    U.K.
    I can't say how sad I am at this initial news, but unfortunately that's good science. My heart is breaking for the wider impact of this but this is what good science does and Fluge and Mella have been extraordinary scientists and I am so grateful for what they have done and continue to do. Would like to see P values etc but , damn damn damn.

    EDIT: On a positive note perhaps F and M have elucidated some findings that are important through this research such as PDH, PDK1 etc.....it may still come to fruition.


    B
     
    Last edited: Nov 21, 2017
    justy, TrixieStix, Mel9 and 23 others like this.
  7. Tally

    Tally Senior Member

    Messages:
    364
    Likes:
    853
    As disappointing as this is, there are many positives in this.

    We got excellent, honest reserchers in Dr. Fluge and Mella interested in our illness. They collected a lot of important data, started a biobank, are continuing research with different drug etc.

    They may still be able to identify subgroups or show that there are no subgroups and that indeed something like Suramin might help us all.

    One way or another, we have learned something more about our illness.
     
  8. deleder2k

    deleder2k Senior Member

    Messages:
    1,128
    Likes:
    4,856
    Thanks. Non responder. No effect whatsoever. Perhaps I should change my profile picture? :) To be honest I think that some patients that participated in the study got worse. It is very tough to go back and forth to the hospital. Some had to catch a flight to do it. Lets hope that most patients didn't get permanently worse. It will be interesting to read the study when its published.

    Think about where we would be without this research. Many researchers has gotten interested in the field partly due to this research. Another thing is that they see FMD dysfunction as Newton do. We should also remember the interesting PDH research.
     
    JD_Lucas, J.G, justy and 30 others like this.
  9. MartinDH

    MartinDH Senior Member

    Messages:
    252
    Likes:
    775
    There is a German doc in Munich who is treating a CFS-patient that got much worse under Rituximab. He is completely disabled due to only one injection. I don't know if he has ever recovered... But I think he did not!
     
    simeyss, pattismith and Countrygirl like this.
  10. Scarecrow

    Scarecrow Revolting Peasant

    Messages:
    1,904
    Likes:
    5,392
    Scotland
    I'm so sorry.
    Absolutely. :thumbsup:

    I think the common themes in everyone's reactions, despite our disappointment, are gratitude to Fluge and Mella and taking consolation from what they have managed to achieve so far. They have definitely given hope for the future.

    In case anyone is thinking Julia Newton in Newcastle, this is a reference to DJ Newton in Dundee (I am assuming).
     
    deleder2k, MEMum, Aroa and 3 others like this.
  11. Sasha

    Sasha Fine, thank you

    Messages:
    12,812
    Likes:
    34,312
    UK
    Jo Best, Cheesus, MEMum and 4 others like this.
  12. Nickster

    Nickster Senior Member

    Messages:
    306
    Likes:
    2,399
    Los Angeles, CA
    I thank you for trying and being a soldier in this disease. Sorry it did not work. That's hard.

    Have you heard how the trial is for the cyclo study?
     
    Last edited: Nov 21, 2017
    Daydreamer45, Ash, Binkie4 and 5 others like this.
  13. Kati

    Kati Patient in training

    Messages:
    5,479
    Likes:
    19,663
    Thank you for sharing this news, despite it being a negative study.

    I would also like to thank the research subjects who submitted to either receiving the drug or the placebo. I would like to thank Drs Fluge and Mella for giving it a try. I hope they will continue researching us. Only through clinical trials and competent research will we know what will work and what doesn’t work. And as someone mentioned above, we definitly needs objective measures in order to move forward in the science of ME to measure recovery. I am looking forward to read the papers.

    Perhaps it would be a good day to make a donation to your favorite researchers.

    We cannot go backwards.
     
    Last edited: Nov 21, 2017
  14. TenuousGrip

    TenuousGrip Senior Member

    Messages:
    294
    Likes:
    1,087
    Well ... that's definitely a serious sack of Seconal.

    But I'm going to do what I've (and I'd guess many others) become so much better at than I once was: I'm going to grieve this as yet another loss, and then go back to living day by day, hour by hour, minute by minute, and second by second.

    Yes. Failures teach science almost as much as successes. I will try to remind myself of this.
     
    JD_Lucas, justy, Joolz and 14 others like this.
  15. alex3619

    alex3619 Senior Member

    Messages:
    13,166
    Likes:
    37,492
    Logan, Queensland, Australia
    Yes. They explored a very important possibility, and got a result. They also have not stopped yet, though Rituximab looks like being a dead end for now. This is how science is supposed to work. Disappointing results are still a part of the scientific record.
     
  16. HowToEscape?

    HowToEscape? Senior Member

    Messages:
    605
    Likes:
    801
    Well conducted research is never bad news. What’s bad news is sloppily conducted research, research that doesn’t distinguish our disease from some other chronic disease such as depression, Or some form of go buzz off disguised as research. Yeah it would’ve been much better if this turned out to be a widely applicable treatment, but reliable data of any kind is valuable.
    You probably know the quip from Edison who said he had discovered 997 ways not to invent the lightbulb. That’s how discovery works, except the Publis city afterwards doesn’t mention the 10 years of trying before the 10 seconds of triumph.
     
  17. Hip

    Hip Senior Member

    Messages:
    11,337
    Likes:
    19,337
    Odd how this Fluge and Mella phase III trial failed to find any positive effect, yet Kolibri Medical clinic in Norway reported that rituximab treatment cures ⅓ of ME/CFS patients, makes an improvement in another ⅓ of patients, and has no effect in the final ⅓ of patients. Ref: 1

    This Kolibri's results are consistent with the phase II study, which found 60% of patients made a major improvement.



    Although these phase III negative finding are more in line with Dr Chia's comment:
     
    Last edited: Nov 21, 2017
    justy, Cheesus, cigana and 10 others like this.
  18. Seven (formerly lnester7)

    Seven (formerly lnester7) Seven

    Messages:
    2,838
    Likes:
    4,171
    USA
    I expected at least to see the 30% of autoimmune as positive results. This is very bizarre disappointing:cry::cry::cry::cry: and unexpected, I feel as if my Puppy died. :cry::cry::cry::cry::cry:
     
  19. MartinDH

    MartinDH Senior Member

    Messages:
    252
    Likes:
    775
    I think it's all about identifying the subgroups. But as a first step one has to find a general biomarker. Then, maybe, everything and the failure of this Phase III study will make sense...

    I am excited what the echo will be. Hopefully it's no wind in the sails of the CBT community...
     
  20. Ben H

    Ben H OMF Correspondent

    Messages:
    966
    Likes:
    10,745
    U.K.
    Yep, we need a biomarker.

    And the sails of the CBT crew have so many holes in them, they could only dream of conducting such thorough, rigourous research. Let alone understanding it...

    But im pretty sure we will get a 'This is why Phase III trials are so important' from them (despite not adhering to that themselves ofcourse, or accepting null results, or managing to design a study without a plethora of flaws etc etc).


    B
     
    Last edited: Nov 21, 2017
    Learner1, Jo Best, MEMum and 7 others like this.

See more popular forum discussions.

Share This Page