Professor & patients' paper on the solvable biological challenge of ME/CFS: reader-friendly version
Simon McGrath provides a patient-friendly version of a peer-reviewed paper which highlights some of the most promising biomedical research on ME/CFS ...
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Fluge & Mella's pre-trial study highlights life-changing potential of rituximab

Discussion in 'Phoenix Rising Articles' started by Sasha, Jul 1, 2015.

  1. Sasha

    Sasha Fine, thank you

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    What, literally? Have they been nominated?
     
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  2. 2Cor.12:9

    2Cor.12:9 Senior Member

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    I'm really late to the party here as I just joined PR - But this does look promising.

    @Legendrew - I'm so happy for you! I've had this for 29 years (severe-moderate) and it's been my experience with a number of friends who have had CFS that recovered to your level within the first few years of illness, that they have remained well to this day. I'm holding a good thought for you.

    @Sasha & @Simon - Thank you for your labors of love.
     
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  3. Izola

    Izola Senior Member

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    Sorry, Andrea that this disease is hurting you so badly. Today, I am feeling sorry for me but just because of symptoms, not data. I'll go try and:hug: gather some good healthy, cheerful spirits and ask if they would surround us all. iz
     
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  4. Izola

    Izola Senior Member

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    Mine was Social Psychology! :p iz :D
     
  5. Izola

    Izola Senior Member

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    Duncan:
    Many of us were diagnosed with floppy diagnostic criteria. I just read a medical article directly responding to and arguing at the ICC. Many of the criteria are floppy. And CDC intentionally set the stage to create diagnostic havoc 3 decades ago. And, boy, they did.

    I just got denied help by the state even though my medical and other situations are desperate I can walk only a few feet but then relapse. And yet this state person started yelling at me that nothing was wrong with me and slammed the door. She really did a long, crazy madwoman on me. The stress was so immense I've gone into a state of collapse, which I was just teetering on before then. It appears that she doesn't think ME or CFS are real.

    One of the first things that goes in me is that I cannot talk coherently, which is pretty much always. We're all a bit different. :D

    The CDC sure made a mess of things. So, there are thousands of doctors diagnosing thousands of pts. more so these last 30 years, using many dozens of criteria, through the minds of drastically different doctors and other people, some of dubious minds and intent and others a spiritual awakening and if we all thought alike, what would we say to each other to make us feel better.

    It's good this site has an effective posse, hehe ;). :)

    I have just gone into spasms, my hands arms flailed and accidentally blasted my keyboard and my computer went blank, so, hope I made some sense and didn't offend.

    Take care. iz
     
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  6. Sallyagerharris

    Sallyagerharris

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    I know we still have not even started the UK Rituxamib trial but I am wondering what the realistic time scale is when - if successful - Rituxamib could be used to treat people living with ME?

    Will the UK medical authorities accept clearance from Norway or do we have to go through all the phases in the UK? I have no idea whether the fact that Rituxamib being used for other illnesses helps to "speed" up the process?

    If Norway does find it to officially be successful and they have signed off on this then could somebody from the UK pay privately to be treated in Norway? Or in the US?

    I again do not know the process but I think in the US there is a patent coming to the end for Rituxamib ... Does this mean the drug may become more accessible?

    Thank you for any guidance. There just seems to be some true hope that some of us might have a chink of light but obviously the years go by ...

    Sally
     
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  7. Scarecrow

    Scarecrow Revolting Peasant

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    I can't remember exactly where this was discussed but @charles shepherd conservatively estimated not before 2022. He seemed to suggest that a UK Phase III trial would be required.

    I'd start saving for private treatment now if you're in a position to. We're likely to know the Norway results in 2018.
     
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  8. Sallyagerharris

    Sallyagerharris

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    I think saving is the right word but a lot of it. "Luckily" ME prevented me from being able to have the children I desperately wanted, so I'll start to put pennies aside and hope the end of the patent might mean the price lowers in the future.

    Of course as I age the possibility of recovery looks as though it might fade .. Hmmmm
     
  9. Sasha

    Sasha Fine, thank you

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    It hadn't occurred to me that private treatment in the UK would be possible even if it wasn't available on the NHS but is that likely? Wouldn't there be problems with a doctor prescribing something like rtx off-label in the UK?

    @Jonathan Edwards (is there no end to the questions that we can ask you about rtx!)?
     
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  10. Violeta

    Violeta Senior Member

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    I don't know, but the "off-label" would probably have to carry the same warning.

    "
    IMPORTANT SAFETY INFORMATION
    BOXED WARNINGS

    WARNING: FATAL INFUSION REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

    • Infusion Reactions: RITUXAN administration can result in serious, including fatal infusion reactions. Deaths within 24 hours of RITUXAN infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RITUXAN infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion reactions
    • Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving RITUXAN
    • Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with RITUXAN, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RITUXAN. Discontinue RITUXAN and concomitant medications in the event of HBV reactivation
    • Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving RITUXAN
    Warnings and Precautions
    TUMOR LYSIS SYNDROME
    • Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, some fatal, can occur within 12−24 hours after the first infusion of RITUXAN in patients with NHL. A high number of circulating malignant cells (≥25,000/mm3) or high tumor burden, confers a greater risk of TLS. Administer aggressive intravenous hydration and anti hyperuricemic therapy in patients at high risk for TLS
    INFECTIONS
    • Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of RITUXAN-based therapy. Discontinue RITUXAN for serious infections and institute appropriate anti infective therapy
    CARDIOVASCULAR
    • Discontinue infusions for serious or life threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of RITUXAN for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina
    RENAL
    • Severe, including fatal, renal toxicity can occur after RITUXAN administration in patients with NHL. Monitor closely for signs of renal failure and discontinue RITUXAN in patients with a rising serum creatinine or oliguria
    BOWEL OBSTRUCTION AND PERFORATION
    • Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving RITUXAN in combination with chemotherapy. Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur
    IMMUNIZATION
    • The safety of immunization with live viral vaccines following RITUXAN therapy has not been studied and vaccination with live virus vaccines is not recommended
    LABORATORY MONITORING
    • Obtain complete blood counts (CBC) prior to each RITUXAN course
    Additional Important Safety Information
    • The most common Grade 3 or 4 adverse reactions in clinical trials of NHL and CLL were infusion reactions, neutropenia, leukopenia, anemia, thrombocytopenia, and infections. Additionally, lymphopenia and lung disorder were seen in NHL trials; and febrile neutropenia, pancytopenia, hypotension, and hepatitis B were seen in CLL trials
    • The most common adverse reactions (incidence ≥25%) in clinical trials of NHL and CLL were infusion reactions. Additionally, fever, lymphopenia, chills, infection, and asthenia were seen in NHL trials; and neutropenia was seen in CLL trials
    • Pregnancy: Category C. There are no adequate and well-controlled studies of rituximab in pregnant women
    For additional safety information, please see the full prescribing information, including BOXED WARNINGS and Medication Guide.

    Attention Healthcare Provider: Provide Medication Guide to patient prior to RITUXAN infusion.

    You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

    You may also report side effects to Genentech at (888) 835-2555.

    © 2015 Genentech USA, Inc. and Biogen Idec Inc. All rights reserved. This site is intended for U.S. residents only.
    Jointly Marketed by: Biogen Idec Inc. and Genentech USA, Inc. Rituxan® is a registered trademark of Biogen Idec Inc.

    • [​IMG]
    • [​IMG]"
     
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  11. Scarecrow

    Scarecrow Revolting Peasant

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    Probably.

    But I've never been to Norway.
     
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  12. Sasha

    Sasha Fine, thank you

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    I'd assume so - but I think I must be missing your point.
     
  13. Sasha

    Sasha Fine, thank you

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    Which raised the interesting question of whether we could all just get on the boat.
     
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  14. Scarecrow

    Scarecrow Revolting Peasant

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    Thanks, that's cheery.

    Then again, what are our options? Take a chance with very low risk or not have much of a life. Tricky.

    NOT!!!
     
  15. Sallyagerharris

    Sallyagerharris

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    Am I right they rituxamib is a biotech medicine that would mean it is difficult to produce it as a generic drug? My understanding is limited as I'm sure you can tell, but trying to learn and to not develop false expectations.

    Having had ME for 9 years (not as long as many others) but noticing a significant progression particularly over the past 2 years and having become nearly totally bed and house bound I am eager to fully understand and accept how this works?

    Sally
     
  16. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    Generic rituximab exists. It is made in India and is called reditux. Making generic biologics is no problem if you have the technology. There are issues about checking equal efficacy but there is no big problem here. Cost will come down sometime fairly soon.
     
  17. Sallyagerharris

    Sallyagerharris

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    Thank you!!
     
  18. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    There is no particular problem with prescription off label. I did it for years. A few patients paid for their drug although everything else was done through NHS. I personally would not want to offer rituximab for ME unless I was actually doing a trial or at least collecting data for publication. There is still a lot of uncertainty. I might feel differently if ME had been my special interest as a clinician I admit. But the commitment to long term ongoing patient care with the potential for unpredictable troubleshooting is huge. I could handle that as a cushioned academic working on RA but very few physicians who know how to use rituximab will be in a position to offer it in ME. There are a small number who could but they need resources to be able to handle the background planning needed.
     
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  19. Sasha

    Sasha Fine, thank you

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    I had thought that it wasn't possible to get rtx off-label now, even if one could find a willing doctor. Is that wrong?

    I'm a bit confused about whether you're talking about a future situation (when, say, F&M's trial has confirmed efficacy but it's too soon for the NHS to have approved rtx) or now.

    And if we get to the point when the NHS approves rtx for ME, are you saying that you don't think that the doctors here who know how to use rtx will be in a position to offer it to PWME?
     
  20. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    As far as I know it is still possible for doctors to prescribe off label. It would be more or less impossible on the NHS though. I was talking about the current situation. If we have more data, especially the Norwegian trial, then everything changes and use of rituximab before any official NICE decision may be quite realistic, although it will all depend on the circumstances.
     

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