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If the Norway Rituximab trials are a success - Will it be available worldwide?

Discussion in 'Rituximab: News and Research' started by Apple, May 24, 2017.

  1. Demepivo

    Demepivo Dolores Abernathy

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    Thanks for that. I guess the boards you mention contain people like Hugh Perry.

    US activists have had good results talking to NIH Director Francis Collins.

    Do the senior people at the MRC get that it's not a behavioural illness?

    Will they give research money to the likes of Mark Edwards or Julia Newton rather than the endless social science questionnaires of Esther Crawley?
     
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  2. Demepivo

    Demepivo Dolores Abernathy

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    @charles shepherd if the MRC start taking note of developments in the US by the NIH and others that is progress.

    If you're able to comment here. Thoughts on the work of Carmine Pariante?
     
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  3. dannybex

    dannybex Senior Member

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    Well, then you're not going to like what he actually said. At 1:59:35 into this video:

    "...but it'll be another 40-50 years before we find out, so don't get your hopes up too high."

    And that's from someone who's very excited about the drug. He's been around for 40 years, and has seen the failure of Ampligen to get approved in the last 27 years, to the point where it seems like Hemispherx has given up trying.

    Yes, this is a completely different drug, and the NIH is finally warming up to the seriousness of ME/CFS, so even though 40-50, or even 20 years may indeed seem absurd, I think it's reasonable to suggest that FDA approval specifically for ME/CFS will probably take at least 8-10 years. I doubt anything will happen until the results from Norway come out in 2018, then add approximately 2-3 years for each phase of a typical 3-phase trial. Plus, how long will it take for insurance companies to cover the pricey cost, including the infusion itself?

    On the flip side, if one can afford it, we all know there are docs out there who are prescribing it now, and if the Phase III results are favorable, that number should increase.
     
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  4. BurnA

    BurnA Senior Member

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    It's not that I don't like it, i just think it's nonsense.

    I am not sure what you mean by each phase of a phase 3 trial. Are referring to multi-centered trials? If so they can happen in parallel.

    It really depends on the data and how robust it is. If the Norwegian data is good, lets say another UK or US trial commences Jan 2019. One year of infusions followed by one year of followup plus 6 months for data analysis and publication, plus 1 year for regulatory review would seem reasonable. That means sometime 2022.

    But it could be never, if the data doesn't support it.

    Also, worth remembering that hopefully by 2022 we will have a much better understanding of the disease and maybe we wont mind so much if RTX is approved then becasue there will be other better drugs in our sights. Or maybe Cyclo will turn out to be more important, who knows.

    Suggesting dates without meaning behind them is a bit pointless really, (I am referring to David S Bell.)
     
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  5. dannybex

    dannybex Senior Member

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    I'm not sure how to phrase it w/regards to a 'phase 3 trial', it's my understanding that before a drug is approved, it starts w/a Phase 1 trial, which lasts a particular amount of time, then Phase 2, etc. Not sure if that is always the case, but that's what I was basing my estimate on.

    I agree, that it all will depend on the results and also what other research has discovered (or confirmed) within the next few years.
     
  6. antherder

    antherder a.k.a. Princess Dauer, Nematode Nation

    I'm wondering whether the Fluge and Mella Rituximab ME trial would be common knowledge yet within certain medical disciplines. Or is it too early for that?

    Does anyone know? Would most oncologists know about it? What about immunologists? Rheumatologists? Or would they only be aware of it if they had a special interest in ME?
     
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  7. Snow Leopard

    Snow Leopard Hibernating

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    The drug has already been approved for other conditions, the Phase 1 & 2 have already been completed.

    All that needs to be demonstrated is efficacy and that does not require huge trials, just a few independent trials and then a meta analysis will be performed before the data is submitted for approval.
     
  8. Kati

    Kati Patient in training

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    The big problem into approving the drug is that FDA required objective outcome measures. Right now we have only SF-36 and the patient's opinion. if we're lucky they will have provided patients with a fit bit to measure the number of daily steps. We desperately need biomarkers and markers of progress.

    Also each country is responsible for approving drug for a designated disease. Each country has different set of rules. It means that FDA may approve a drug, but Health Canada may require further trials, and good luck with that as the only existing programs are much into self-management and CBT group therapy and not so much into treatments. The cost is a huge problem for socialized health care systems. Unless the trials are VERY convincing, they may not want to cover you. In my opinion the chance that this happens are high due to the stigma and contempt for this disease.

    People keep on saying that Ampligen is approved in Canada. It's not approved for ME it's approved for HIV and it hasn't been used for HIV for a long, long time. When I suggested it to a consultant he pretty much laughed at me. :(
     
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  9. Snow Leopard

    Snow Leopard Hibernating

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  10. Kenny Banya

    Kenny Banya Senior Member

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    Dr Fluge mentioned in a fairly recent tv interview that there have been good results from the Phase III trial, they just don't know if it's RTX or placebo until the results are unblinded in October.
    Of course, we know it's RTX based on the Phase II blinded trials.

     
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  11. BurnA

    BurnA Senior Member

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    Ah OK, but as @Snow Leopard has mentioned that's not required in this case. Phase 1 and 2 are generally for new drug applications rather than existing drugs. See Wikipedia here

    I know that no rheumatologist or immunologist in Ireland knew about it a year ago and neither have any of the general doctors I have spoken to. I doubt that has changed.

    The release of the phase 3 results will change that though. In fairness to Fluge and Mella there was no point in over publicising anything before the results come out.
     
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  12. Kati

    Kati Patient in training

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    See, the problem is that ME belongs to no medical specialty. It means that rheumatologists are in no obligation to learn and to care that there is a response to Rituximab in patients with ME, because they have no responsibility towards our patients population.

    It reminds me of the rheumatologist who replied in a formal letter when I sent a copy of the initial Fluge/Mella paper, asking them if they would be willing to start a trial here in Canada. He said he had no time nor interest in caring for patients with ME/CFS. He is deeply involved in clinical trials for rheumatology. Typically it takes 9 months to be seen by a rhematologist over here, sometimes more.

    We are facing stigma and contempt. i have great doubt that this attitude will change with a single paper. They, the doctors, family practitioners and specialists will need to be educated widely and just as a word of caution, physicians hate to be educated by their own patients.
     
    Last edited: May 27, 2017
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  13. antherder

    antherder a.k.a. Princess Dauer, Nematode Nation

    Exactly. The stigma is still going to be the biggest barrier to treatment, in my opinion.

    Whenever I've mentioned research in the past, it has always been to my own detriment.
     
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  14. Kenny Banya

    Kenny Banya Senior Member

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    LOOOOOOOOL.
    I educate them all the time!!
    I even tell them what to do!!
     
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  15. snowathlete

    snowathlete

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    I think Charles is right, that four years from publication (assuming the results are positive) of the Norwegian study is about right in the UK, before we can access the treatment. And that's if we push hard with advocacy, harder than ever before. If we fail to push hard enough then it could easily end up taking twice as long, in my opinion.

    It ought to take much less time but the system we are working in is not fit for purpose.
     
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  16. Snow Leopard

    Snow Leopard Hibernating

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    It's all hype/speculation until the results are released - don't hold your breath...
     
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  17. Kenny Banya

    Kenny Banya Senior Member

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    It isn't hype at all. He said people are responding. October unveiling is a formality.
     
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  18. MEMum

    MEMum Senior Member

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    When i had tea with Dr Mella at IiME two years ago he said that NO unblinding would be done until the last patient to be treated had finished the trial. Otherwise it would put the results at risk of bias.

    I am looking fwd to hearing their progress this Fri at IiME. They were not at the conference day last year.
     
  19. MEMum

    MEMum Senior Member

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    If the results are encouraging, I think several PR members will be on their way to the private clinic in Norway.
     
  20. maybe some day

    maybe some day Senior Member

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    True..nice to have that kind of money. But the rest of us? Ritux might as well be a pipe dream. I have an HMO, and theres no way they will approve that type of treatment. Maybe the up and coming unfortuneate ME young adults will have a better outcome by the time they are 50.
     
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