The 12th Invest in ME Research Conference June, 2017, Part 2
MEMum presents the second article in a series of three about the recent 12th Invest In ME International Conference (IIMEC12) in London.
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How can we help accelerate Dr Naviaux's ME/CFS Suramin trial?

Discussion in 'Advocacy Projects' started by Jesse2233, Aug 12, 2017.

  1. Jesse2233

    Jesse2233 Senior Member

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    I have been corresponding with Dr Naviaux

    Salient points:
    • Bayer is currently the world supplier of suramin and they will only supply the drug and no money for clinical trials

    • Bayer will not supply suramin if another company is funding the clinical trial

    • Doctors outside of the US will run into similar issues

    • The practical solution is to find commercial sponsor who will make their own suramin and will provide funding for the clinical trials

    • Need at least 4 clinical trials to answer basic questions of pharmacology, safety, and efficacy of suramin in ME/CFS

    • Culminate in a Phase III multicenter trial with about 200 patients, will take about 5 years to complete
    My next step is to figure out if another company has agreed to fund / supply Suramin and if not, if that's something the community can help with
     
    Last edited: Aug 17, 2017
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  2. necessary8

    necessary8

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    Good work on contacting Naviaux directly, @Jesse2233

    I keep wondering about one thing. Many ME/CFS doctors tried many things on their patients experimentally, just giving it to them off label and seeing if it works. Like the recent rapamycin case.

    Can we do that with suramin? It has a much stronger basis to suspect it will indeed work than many of the things tried already. And its probably even safer than most of them.

    This method wouldn't produce a nice, clean paper proving that suramin is the treatment for ME/CFS, but we would at least have some early knowledge if it can work.

    This method wouldn't require millions of dollars of funding, or years to complete. It would just need a willing patient, who there are plenty of, a willing doctor, who I'm sure we can find, and the drug itself.

    Would Bayer sell the drug for that kind of thing? If not, is there any way to buy some of it from them without stating a purpose, and just use it for this?
     
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  3. wastwater

    wastwater Senior Member

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    Stemcell.com has suramin listed and says its also a competitive inhibitor of reverse transcriptase
     
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  4. necessary8

    necessary8

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  5. greeneagledown

    greeneagledown Senior Member

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    If Bayer will supply the drug for free, can't Naviaux just get Suramin from Bayer and get the money for the trial from donations from the community, rather than needing involvement from another company? If he limits this first trial to something like 10 patients, I wouldn't think it would be all that expensive; I believe he intends to only do one infusion in each patient. Did he say that wouldn't work?

    If the drug is donated from Bayer and each patient receives only one infusion, I don't see why this would be expensive.
     
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  6. necessary8

    necessary8

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    The trial he did on autism, which was exactly as you describe, cost $1,2 million, which is apparently cheap as far as trials go. What exactly costs that money and why it cant be cheaper - that's a question I never quite found an answer to.
     
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  7. Murph

    Murph :)

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    I have worked a lot on budgeting and I continue to find it fascinating. Humans often tend to underestimate costs because we imagine that our task is a slight extra burden for organisations that we imagine are already flush with funding.

    If you think about the trial's marginal costs: 10 injections of suramin - it must seem cheap. But if you're paying your share of the salary costs of everyone involved, and your share of the fixed costs of all the organisations involved (they bill you enough to cover their rent, elecrticity, pensions, etc.) then it obviously adds up.

    Something like a clinical trial has a lot of admin involved and admin is expensive. For example, getting human research ethics committee approval includes not only a lot of work by people inside your organisation ,who must be paid and provided an office to work in , etc., but also an application fee that can be worth several thousand dollars, to help fund the decision making process.

    Once you think about all the organisations involved and imagine that you have to fund them for all their costs, not just rely on them doing just a tiny bit of extra work for you gratis, it adds up.

    I found this explanation helpful:

    "Once approved, we need to recruit physicians to run the trials, patients to participate, nurses to perform care and administrators to do all the documenting and reporting to various oversight bodies. A company usually pays a research organization to set this up, which adds additional cost.

    Once the skeleton of the trial is in place, you have to train researchers, physicians and nurses to administer the trial and accumulate all the necessary resources (drugs, hospital space, medical equipment, medical supplies, etc.). There is also a large cost associated with monitoring compliance with the study protocol and various regulations governing clinical trials. Similar costs associated with monitoring clinical outcomes (known as pharmacovigilance). Constant reporting and documentation during this whole thing. And you need people to analyze the data and make decisions on how to proceed. The sponsoring company also needs people on the business end making sure things are going to be budgeted appropriately when inevitable delays, trial drop outs, etc. happen.

    On top of all this, you have the medical costs of the enrolled patients. Medical technology is improving all the time and more and more procedures are being used to evaluate patient response. Think routine exams, blood work but also MRIs and speciality tests. This ups the cost per patient significantly. Clinical staff to handle all that is expensive."
     
  8. greeneagledown

    greeneagledown Senior Member

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    Geez louise. That really sucks, man.
     
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  9. necessary8

    necessary8

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    Very true.


    However...

    I would think one Naviaux with an assistant would be enough to administer a few IVs, and then asses symptom improvements, no?

    As for patients, just use few ones from the metabolomics study who already had their diagnosis confirmed by Naviaux's lab.

    I'm saying we dont need all that this to do a simple suramin trial.


    The one thing I agree can cost a lot in a trial like this, is red tape. Meeting all the regulations. That's why I'm proposing to cut that out by not making this an official trial, just an administration of a drug off-label. I think you have to consider the urgency of the matter. Innovation is often made by ignoring procedure.

    The answer to why that's not possible might be that Bayer won't supply the drug unless its a proper clinical trial with all the expensive red tape in place.

    I'll also say I'm very uneducated in this matter so please don't take my post too seriously. I just still haven't seen a proper explanation why it HAS to cost so much, and I'm curious. But in the end I trust that dr Naviaux is doing everything he can, even if I dont understand all the reasons for everything.
     
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  10. shannah

    shannah Senior Member

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  11. shannah

    shannah Senior Member

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    @Jesse2233

    Any progress being made?

    Do you know if Naviaux is still planning on starting a Suramin trial for ME before the end of the year as he mentioned? The Autism community is fundraising for the next Suramin/Autism trial. Is there any similar fundraiser going on specifically for a Suramin/ME trial?

    Thanks!
     
  12. perrier

    perrier Senior Member

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    Amongst the highest rates of MS too.
    Miserable climate...
     
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  13. perrier

    perrier Senior Member

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    I heard through the grapevine, ( not sure it's reliable in the least) that Dr Naviauux will not be focusing on ME but on autism for now.

    Someone, please update.

    And any updates on availability of
    this med?
     
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  14. adamjfpickering

    adamjfpickering

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    So right now i've been in contact with 3 persons who have obtained the drug from 2 different sources, one person was able to obtain the drug (Bayer 205) via a connection in Tanzania, and the other two are going to take a research version of the drug. All persons taking the drug will be low dosage 1g in 50ml IV to see if any effects are noticed.

    I think this is the way that the ME/CFS community should continue with its own research of using Suramin as it seems there's not much interest from the research community at the moment, but I could be wrong. Autism currently is something that is getting much more interest.

    CC'ing @Jesse2233 @perrier @shannah @necessary8
     
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  15. Jesse2233

    Jesse2233 Senior Member

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  16. adamjfpickering

    adamjfpickering

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    Sure, it will be at least 6 weeks before any information can be shared.
     
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  17. Jesse2233

    Jesse2233 Senior Member

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    Ok thanks! Would you be willing to PM me further details on the individuals and their sources? Will keep it confidential
     
  18. adamjfpickering

    adamjfpickering

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    PM what details you are interested in and I shall reply.
     
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  19. dreamydays

    dreamydays

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    I really respect the people who are trying this, I have been considering this or tocilizumab as a personal experiment at home. I would like to point out the standard protocol for an infusion would be to have an epi-pen, antihistamines and prednisone at hand in case of allergic reaction.
     
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  20. Jesse2233

    Jesse2233 Senior Member

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    @dreamydays what got you interested in tocilizumab?
     

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