Lipkin's Monster ME/CFS Study: Microbes, Immunity & Big Data
The Microbe Discovery Project outlines an ambitious new study by top researchers that has collected patient samples, but needs desperately funds to complete the work.
Discuss the article on the Forums.

Rituximab in Australia

Discussion in 'Rituximab: News and Research' started by Hutan, Jun 22, 2015.

  1. Hutan

    Hutan Senior Member

    Messages:
    1,069
    Likes:
    6,425
    New Zealand
    Yes, of course I'm getting way way ahead of myself. Yes, we need to wait until the Norwegian Phase 3 trial results are out.

    But still, I'm thinking about where we could get hold of Rituximab in Australia if the trial does show the results we all hope for.

    Given that the Griffiths University team seem to be the most active in ME research, given they have a clinic and given that they have done some work on B cells, they seem to be the most likely to be interested in running a trial. They were also represented at the recent London conference I think and so will know all about the Rituximab trials.

    I'm flagging some of you who I know are based in Australia. I know some of you are close to the Griffiths team. Is there any indication that they are thinking about a trial? Any ideas on how we might encourage them if the Phase 3 trial looks good? What would be the factors slowing down the establishment of such a trial - other than funding?

    Is Fred1234567 still around? I see he was looking in to Rituximab in Australia a while back.

    @heapsreal ; @alex3619 ; @AndyPandy ; @Snow Leopard ; @ahmo; @angee111
    (and anyone else in Australia)
     
    allyann likes this.
  2. ahmo

    ahmo Senior Member

    Messages:
    4,338
    Likes:
    6,520
    Northcoast NSW, Australia
    I know nothing.:whistle:
     
    Bob and Hutan like this.
  3. heapsreal

    heapsreal iherb 10% discount code OPA989,

    Messages:
    8,876
    Likes:
    8,176
    australia (brisbane)
    I haven't heard of any treatment trials yet. But a few years ago when i was in the nk study, they did seem interested in the b cell research in Norway .

    Im guessing to run a trial they need to jump through alot of hoops but probably waiting for results from other b cell studies.
     
    Hutan likes this.
  4. Snow Leopard

    Snow Leopard Hibernating

    Messages:
    4,613
    Likes:
    12,434
    South Australia
    It would be disappointing if by 2018 we need yet another trial before gaining approval.

    The biggest difficulty will not be finding doctors willing to prescribe the drug, but rather getting the PBS to subsidise it so that we can afford it.

    If any team would be to do further trials, the goal would be to find biomarkers that are associated with improvement on the drug.
     
    MEMum, heapsreal and Hutan like this.
  5. Hutan

    Hutan Senior Member

    Messages:
    1,069
    Likes:
    6,425
    New Zealand
    I guess I was thinking that a local trial would be the quickest way to personally get Rituximab at a cost that is not crippling.

    I suspect I got the phase number wrong - is it the Norwegian Phase 2 not Phase 3 trial results that are imminent? I certainly don't want to wait until 2018 to just start a trial either. Although perhaps realistically it would take that long or longer to get a local trial underway if the NCNED people aren't already thinking about it.

    I was thinking that if there were local proponents (eg the Griffiths NCNED team) who have run a successful trial, that would be very useful in convincing the PBS. But perhaps well conducted foreign trials showing clear benefit would be enough.

    And maybe Rituximab isn't the be all and end all of drugs, simply the one that shows the way for better drugs to follow. And so perhaps we either think about rituximab treatment overseas or just sit and watch for a while.
     
    MEMum likes this.
  6. MEDad

    MEDad

    Messages:
    16
    Likes:
    56
    Norway
    Hi,

    The current Norwegian Rituximab trial is a phase 3 trial, with "gold standard" scientific design (randomized, placebo-controlled, double blinded). The unblinding will happen mid-2017. Any official (journal) publication will probably happen in 2018.

    Another trial that should be of interest, also from an economical point of view, is the current phase 2 cyclophosphamide trial. So far the results seems equally promising as with Rituximab, at only a fraction of the cost (1200 NOK per patient for the entire treatment). This trial will end mid 2016.
     
    MEMum, merylg, alex3619 and 2 others like this.
  7. heapsreal

    heapsreal iherb 10% discount code OPA989,

    Messages:
    8,876
    Likes:
    8,176
    australia (brisbane)

    If we cant get ritux here in oz , it may be available in Asian countries like many do for other medical issues and medical holidays and would probably work out cheap with 5 star accommodation than paying for it off label but a big IF getting it off label here.
     
    RustyJ and Hutan like this.
  8. Snow Leopard

    Snow Leopard Hibernating

    Messages:
    4,613
    Likes:
    12,434
    South Australia
    It seems like unnecessary risk to save a few thousand dollars.

    @Jonathan Edwards has warned us against being treated by those who have no expertise in best-practises to maximise effectiveness and minimise risk.
     
    MEMum likes this.
  9. heapsreal

    heapsreal iherb 10% discount code OPA989,

    Messages:
    8,876
    Likes:
    8,176
    australia (brisbane)

    I would assume that people would do their own research . Some hospitals involved in these medical holidays have australian and american trained doctors. Im sure rituximab is used by more than just a handful of doctors who are experts.

    I don't think it would be about saving money (the way things are priced here not covered by pbs im sure it will be more than a few thousand ) more to do with drs who will treat using rituximab . I dont think it will be used here for awhile ? Recently there was an Australian woman with ms who could not get the treatment she was after ie stem cells and a chemo drug due to politics in australia. She then went to Russia for this treatment which cost her $100k?? This treatment it was said has been used in russia for over a decade as well as other countries . she is now in remission and has her life back instead of life in a wheelchair or bed bound.

    Getting treatment overseas is an option when we really have no clue as to when rituximab or if it will be an option in the near future .

    I think its good to have options and allow individuals to make that decision .
     
    Daffodil and Hutan like this.
  10. alex3619

    alex3619 Senior Member

    Messages:
    12,479
    Likes:
    35,004
    Logan, Queensland, Australia
    I think there was an offhand comment about Rituximab by someone at NCNED a few years ago.

    This drug could be fast tracked here, if there was political will, within (a guess) six months. Developing the infrastructure to deliver it to tens of thousands of new patients ... expect very very long waiting lists. Years. Maybe you are at the head of the list. Maybe you have to wait. Fixing that will take political will by state governments, and is a whole other debate.

    If regular TGA procedures are in place it could take years for approval. That is even after we have a clinical trial. Without a clinical trial it could be many more years.

    I have flagged this issue for discussion several times now, but not started a thread. We need this thread.

    Asian travel for treatment, medical tourism, will not help the very sick. Sadly. Many will not be able to handle the travel. Doing it three or four times a year or so is a big ask for many of us.

    I am wondering if the TGA, like the FDA in the USA (all those three letter acronyms!), has an exemption for orphan diseases that have no other treatments? If it does not then we have a target to achieve. We might be able to sell this to even our current government, as the long term savings of getting us off a pension are huge.

    I would love it if we had a biomarker that showed who might respond. That would help us immensely. Without it we might be able to get subsidized treatment, depending on then current regulations, if we are a known responder. Which might mean several holidays in Asia until we know if we can respond.

    On the upside the food options in Asia are at least interesting. I was born in Malaysia in case anyone here is unaware, and grew up with interesting menu options. My father was in the army here, and we almost went to war back in the early 1960s ... with Indonesia and with the communists from Thailand.
     
    allyann, L'engle, Hutan and 2 others like this.
  11. heapsreal

    heapsreal iherb 10% discount code OPA989,

    Messages:
    8,876
    Likes:
    8,176
    australia (brisbane)
    @alex3619
    i think NCNED are mostly looking into ways to diagnose cfs/me with proper biomarkers etc. It was an off hand statement i heard from them about rituximab and I had the impression that they thought the cause of the low nk function was autoimmune related ?

    your right in that there are alot of things that have to happen before its a common treatment for ME here , even if the Norway research is positive. Even the new you beaut cancer drugs can have problems getting approved especially if there are cheaper alternatives.
     
    Hutan and EtherSpin like this.
  12. Snow Leopard

    Snow Leopard Hibernating

    Messages:
    4,613
    Likes:
    12,434
    South Australia
    It does not matter who does the trials, simply that high quality trials have already been done (eg UCL, Haukeland). Typically a meta analysis would be presented as evidence of efficacy.

    Most drugs on first approval require insensitive studies demonstrating safety. We already have that data from the drugs use in Lymphoma and RA.

    The drug itself was approved for RA (as a back up therapy) relatively quickly, taking around a year or so.

    The tricky bit is not the approval of the drug for use, but rather getting the PBS to subsidise it. Without this, few will be able to afford it anyway.

    If/when it is approved by the PBS, there will be more than enough doctors willing to capitalise on new opportunities to treat patients.
     
    MEMum and Hutan like this.
  13. alex3619

    alex3619 Senior Member

    Messages:
    12,479
    Likes:
    35,004
    Logan, Queensland, Australia
    Yes, agreed. I should have been more specific. The PBS requires not just safety data, and not just efficacy data, but data showing cost effectiveness. This is in fact our wedge opportunity because there are no other options on the market that are approved.
     
    MEMum, Snow Leopard and Hutan like this.
  14. alex3619

    alex3619 Senior Member

    Messages:
    12,479
    Likes:
    35,004
    Logan, Queensland, Australia
    Here I have to disagree that this will make a difference. Rituximab infusion requires specialized infusing services. That requires trained staff. We are geared for a certain number of cancer and arthritis patients. It will take time to increase capacity to cope with the huge backlog of CFS and ME patients.

    The point of us discussing this now is we can begin getting this on state and federal health minister's and their bureaucracy's radars. They need to be planning what to do in the event its proven effective. They need to consider fast tracking the process. They need to consider infrastructure for delivery. They need to consider what impact this might have in other ways.
     
    merylg, heapsreal and Hutan like this.
  15. Snow Leopard

    Snow Leopard Hibernating

    Messages:
    4,613
    Likes:
    12,434
    South Australia
    The training is not that difficult. A short training programme perhaps (such training already exists for RA treatment). Services will be delivered at major hospitals. As I said, the biggest hurdle by far is PBS approval.
     
  16. Jill

    Jill Senior Member

    Messages:
    207
    Likes:
    708
    Auckland, NZ
    How about approaching Roche? I have a friend that works for them here in NZ. He said that they have s worldwide compassionate care ( or similar wording) system within the company. He said here in NZ, prob the best way to go is to get a hospital specialist ( of which we don't have any good believers) to apply to the ministry of healthy ' special funding'. He said it's done all the time esp in oncology. For us here in Auckland we don't have any good hospital doctors. Just been thru a nightmare 3 months with partner who was taken by ambulance to hospital , can't walk or self care and they still insisted CBT and get were the answers. Auckland is devoid of help at the senior level.
     
    MEMum, daisybell, Hutan and 1 other person like this.
  17. Snow Leopard

    Snow Leopard Hibernating

    Messages:
    4,613
    Likes:
    12,434
    South Australia
    Roche won't be interested at all, until the results of the Norwegian study comes back. If it is successful, then I dare say they will be quite active in Australia/NZ trying to get approval and doctors interested...
     
    Hutan likes this.
  18. RustyJ

    RustyJ Contaminated Cell Line 'RustyJ'

    Messages:
    1,191
    Likes:
    891
    Mackay, Aust
    Ì am not getting any younger... others must be in the same boat ;) , so would it be prudent to plan to get infusions overseas? Surely Norway will approve first. I am prepared to travel/live there for term of treatment. It's not worth even waiting 12 months for Australia to follow on. Is that a suitable strategy or does someone have a better suggestion.

    Edit. Sorry missed a couple of posts. Anyway, I would pay more to get treatment in Norway, however Asian treatment might be available now?
     
    Last edited: Jul 2, 2015
  19. RustyJ

    RustyJ Contaminated Cell Line 'RustyJ'

    Messages:
    1,191
    Likes:
    891
    Mackay, Aust
    They used this for upcoming Ampligen trial in Australia. Bear in mind this was a commercial enterprise pushing Ampligen. Difficult to see how this would apply for Rituximab.
     
  20. RustyJ

    RustyJ Contaminated Cell Line 'RustyJ'

    Messages:
    1,191
    Likes:
    891
    Mackay, Aust
    I agree. It is a matter of time primarily for me. Money is secondary, although still important. If there was an option in Asia before Norway comes on line, or Australia, I would grab it. Frankly given my lifestyle - rarely moving ten metres from my bed - a move to a good Asian neighbourhood wouldn't be too bad. As long as they had the internet.
     
    heapsreal likes this.

See more popular forum discussions.

Share This Page