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SBM: Kogelnik, Rituximab and CFS: Jumping the gun

Discussion in 'General ME/CFS News' started by Firestormm, Jan 13, 2013.

  1. Firestormm

    Firestormm Senior Member

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    SBM 8 January 2013: Hariet Hall: http://www.sciencebasedmedicine.org/index.php/rituximab-for-chronic-fatigue-syndrome-jumping-the-g/

    Plenty of comments beneath this blog. Hadn't seen it recorded on this forum and I felt it raised some issues that were worth further consideration.
  2. alex3619

    alex3619 Senior Member

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    I think these are all good questions being asked, but the problem is: what are alternatives? People are dying. People are highly disabled. People are suffering. The treatment also fits several current models of ME. The success rate also makes CBT/GET look sick. The only argument is that its too small a statistical sample. How do you correct that? Add more instances. This might not be the ideal medical trial we want, but the funding for that is still lacking, which means we will have to wait at least another five years for treatment. How many will die in that time? How many years of suffering will be endured? There are currently no medical proven and approved treatments that increase functional capacity (that includes CBT/GET). This is an orphan illness, and treated like it, despite the very high prevalence compared with other such diseases.

    In essence from the patient perspective it can be argued only that we have too much hope on this and other issues. The counter argument is that its unproven hope, and people can take advantage of that. Our hopes can then be dashed if it fails. This misses the point though ... without hope things would be so much harder for so many of us. We are faced with a situation that we, as patients, might have to fund expensive clinical trials if we want action.

    If we had three or four effective treatments already proven and approved, then it would be fair to say that something new needs to be scrutinized more carefully. However with almost no approved options, all we can do it give up, crawl into a hole, and hope the future gets better ... OR we embrace hope and take action to advance the science.

    Every treatment for ME and CFS is experimental to some extent, and I am including CBT/GET in that, I do not consider it evidence based in the sense that term is commonly used. This doesn't happen in most other diseases.
  3. Valentijn

    Valentijn Activity Level: 3

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    They really just don't get it. We have a disease with no proven effective treatments, and many doctors won't take it seriously enough to even deal with symptom management.

    If they think sitting around being horribly ill and disabled and in pain for years or decades is so much fun, they should climb down from the pulpit and give it a try themselves.
  4. alex3619

    alex3619 Senior Member

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    Yet ME has no established treatments, no alternatives, and CBT/GET has never been demonstrated to improve functional capacity. Its a question of choice. We have no alternatives that are "approved" except those that don't really work. So these are all good points raised, but they lack context, background, depth.
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  5. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    The person who wrote that article i think should put their money where their mouth is and start advocacy for us for further research and effective treatments. Its all good bagging the hell out of drK and the open medicine institute but they arent offering any solutions. Open medicine are doing the best they can for us with what they have, not just bystanders watching cfs/me suffer with no effective treatments.

    Im guessing its a psychobabbler who wrote this article to promote their ineffective treatments like cbt/get??
  6. alex3619

    alex3619 Senior Member

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    Not a babbler, but someone ignoring babble. However she is a retired ex-military MD.
    MishMash likes this.
  7. free at last

    free at last Senior Member

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    Its easy for those that are not suffering, to pull apart, and condem. those that are desperate for help. Any help. yes they dont get it AT ALL some of the points may be valid. But meaningless. in a world of noting but suffering. some would prefer to be dead. But have familys to think of that stop them from the final releif. if those that write these articles. dont consider this strongly, as a reason patients. will try almost anything. for releif. Then they are living in a nice safe world thank you very much. I wonder what they would write. spending years laying down. and years being scared ?
  8. Firestormm

    Firestormm Senior Member

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    I'm still reading the comments and struggling with my words this morning but...

    The main point re: Kogelnik is about this Canadian patient being allegedly told she was part of a 'pilot study' when she wasn't apparently; and being charged serious money for the privilege of this experimental 'treatment'. It is 'iffy' - at least in my own mind. There is also an issue - more so in the comments - about the Open Medical Institute and it's treatment/funding policies.

    The greater issue is about prescribing 'treatments' with significant side-effects that are experimental (for CFS) to desperate patients. There is a guarantee of nothing except a chance that this treatment could lead to long-term side-effects. It is directly relevant to the previous desperation exhibited, speculated and promoted by varous proponents of XMRV and anti-retrovirals. At least for the purposes of this blog.

    It is about science and clinical trials coming before doctors offering off-label unevaluated 'treatments' to people with the waste-basket, exclusionary, heterogeneous diagnosis of CFS. You, me and anyone else do not know if we have the exact same thing affecting us or how we will respond to Rituximab or e.g. Ampligen - and yet some are prepared not only to pay for Rituximab but to travel significant distances for intravenous treatment - repeatedly.

    There is also a concern expressed in the article and more so in the comments about anecdotal reports affecting future hopes for research. That they could 'taint' any attempt to gain approval. There is again perhaps some direct comparison here with Ampligen and the recent attempt at FDA approval when the company, Hemispherex, has failed to provide sufficient evidence or evidence of significant quality.

    In the comments - and there are some really good ones from each perspective - we have people contributing from all over. One from Norway talks about others in Norway travelling to Kogelnik in San Francisco for treatment - repeatedly. I have to ask. How can someone who is housebound and very sick even consider international travel let alone spending such money on experimental and potentially dangerous drugs?

    Of course there is a dumb-ass situation. Norway wants to do clinical trials but they can't get the funding - although the Government wants to fund them. One comment states that they have been part-funded now (but I've been away for a while so don't know the true situation). However, in the meantime, while science moves slowly and may result in a nil finding, what do desperate patients - with money - do? Of course they are going to be attracted by doctors who promote off-label 'treatments'. Got to be better that sitting around waiting for Godo - right? Well, no. I don't think so - but it's a personal choice - with proviso's.

    It is easy to see that those who have obtained or who are hoping to obtain experimental treatment are being criticised. They are not. If a patient has been fully informed, has given consent, and is aware of the consequences - however unlikely they might be - then so what? Well, what about patients who post their experiences on blogs as if they are part of a 'trial' or more generally? What about people who read those blogs and then seek the treatment themselves - and pay for it? Are those posting their experiences in anyway responsible should someone else see their own health fail as a direct result? Where are the disclaimers, the cautionary warnings?

    And what is Kogelnik up to? I would like to hear from him because this individual treatment of patients with Rituximab and charging for it - getting patients in from other countries I personally don't like it. Why isn't he at least running a trial involving these people? Why isn't the trial registered? Why isn't he doing it for free as part of an OMI initiative and why isn't it limited to patients who can travel a reasonable distance for example? As I said I would like to hear from him. Our condition doesn't need any more 'association' placed upon it.

    N.B. There was a couple of very good comments from 'geo' about PACE for those who see some relevance.
  9. Firestormm

    Firestormm Senior Member

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  10. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    if rituxin was as bad as the article was making it out to be, then they wouldnt use it for cancer and autoimmune conditions. It obviously has a good enough safety profile for those uses so should be able to be used for off label conditions used in the right setting. There are many drugs that have been used off label and eventually have then been approved for that specific indication that it was used off label for. I think they are making a fuss about nothing.
    minerva, taniaaust1, penny and 2 others like this.
  11. Valentijn

    Valentijn Activity Level: 3

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    The woman whose blog was quoted on the article posted a comment herself - the 2nd one I think. The impression I get is that she does know what the situation is, but probably used the wrong terminology.

    Regarding opting and paying for the treatment - we are competent adults, and it's a legal treatment. End of story. I don't see the SMB crowd suggesting any alternatives other than wait (a few more decades?) and see what turns up.
    SOC and beaker like this.
  12. Valentijn

    Valentijn Activity Level: 3

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    Yes, it's rather silly. They keep saying "but it's not safe" yet seem unable to provide any evidence of that. And never mind taking into account potential gains weighed against that unsupported claim of risk.
    penny, beaker, ukxmrv and 1 other person like this.
  13. Roy S

    Roy S former DC ME/CFS lobbyist

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    That blog to me has an air of prejudice and condescension. If the blogger had checked maybe she would have easily found what the Open Medicine Foundation has on their list at #1.
    https://www.facebook.com/pages/Open-Medicine-Foundation/309364692501292


    There is HOPE! We are very excited about the Collaborative Research on the table that the Open Medicine Foundation is currently raising funds for!

    The ME/CFS Top Ten Project List is listed below (see www.openmedicineinstitute.org for details and how to help get this started by donating today and helping to fast track this research). The Top Project list for Autism research will follow next week and can be viewed on our website as well.

    1. Treatment: Phase 1: A Large-scale, Randomized, Placebo-controlled Trial of Rituximab and Valgancyclovir.
    2. An International Neuro Registry and Biobank.
    3. Protein Panel in Treatment (bacteria,viral,hormonal,antibody,cytokines)
    4. Treatment: Phase 2: Mono and Combination Pilots (Ampligen,Etanercept,refaxamin,issentris,famcyclovir)
    5. Immunologic Biomarker Exploration Studies (B-cell,T-cell, Natural Killer cells)
    6. DNA Genetics
    7. Mass Spectroscopy/Environmental Measurements
    8. Comprehensive Viral Testing (blood,urine,saliva, tissues for EBV,HHV6, CMV, Parvovirus, HSV1 and HSV2)
    9. Advanced Immunologic Biomarker Study 2 (monocytes, macrophages, dendritic cells)
    10. Treatment: Phase 3: Natural and Over-the-Counter Substances (Moringa oleifera,GcMAF,Vit B12, artemesin)
  14. Firestormm

    Firestormm Senior Member

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    Re: the Canadian Blog. Val, it seems to have 'gone dark' (that's a new term for me but you know what I mean). So I can't even read the context now.

    OK. This raises the whole issue of 'off-label' prescriptions and more importantly in this context - the marketing and promotion of them. I don't have the whole heap of knowledge necessary here - but I will say that I find it 'strange' that Kogelnik is the only one doing Rituximab off-label. He probably isn't but this makes it even stranger for him to be attracting patients from overseas when (presumably) they could get this drug in their own countries or someone nearby.

    If they can't - then one surely must ask - why? And if Kogelnik is 'guilty' of saying things to patients (and the press) which are untrue or have been miscontrued - then I would support the view (expressed by Dr Hall in the comments) that he correct the issue either on this blog or elsewhere and let it be known.

    Is Rituximab 'safe' for use in patients with a diagnosis of CFS? Before Kogelnik uses Rituximab on patients with CFS - what steps does he take to ensure the diagnosis is correct and that Rituximab is likely to work? He might do nothing and I'm not judging here - but I would like to know. I am interested.

    How can a doctor prescribe Rituximab for Rheumatoid Arthritis for one person and not another? What steps are taken to ensure the drug might be effective and are similar steps taken with someone who has an e.g. (I understand) autoimmune condition for which Rituximab might be prescribed?

    I take Gabapentin. It is 'off-label' for my condition (although I do have a diagnosis of Epilepsy but it was prescribed for my ME). However, Rituximab is different. It is different. You can't escape from that fact. But a doctor is apparently entitled to prescribe it's use in ME - and I'd like to know more about how he would do so or if it's a case of simply being prepared to pay for it. I think that's reasonable to know.

    If I had the money now I would not seek to get Rituximab (or Ampligen for that matter). But I don't condemn others who do or if they chose to post about their experiences - so long as their posting is (in my view) reasonable and doesn't promote their own choice as being something 'everyone should do' based only on their own experience.

    No doctor should be promoting Rituximab for ME. Not for ME. On an individual patient basis - as an 'off-label' - then I suppose they are covered to do so. But it's 'iffy'. I don't like it. Doesn't mean others should share my opinion. For anyone on Ampligen or Rituximan I wish them well; but if I come across any doctor promoting it's use widely I think they need to justify it.

    What are the outcomes for Rituximab for Rheumatoid Arthritis? Does anyone know? Is it considered a 'safe' and effective drug? Is it widely prescribed? If so under what circumstances? I mean it is bloody expensive so I'm thinking it has to achieve potentially fine results - especially if it is paid for by someone other than the patient.
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  15. Firestormm

    Firestormm Senior Member

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    I don't see the relevance to the blog topic, Roy. Kogelnik was not prescribing Rituximab as part of any trial or 'pilot study'. Maybe he has left a comment and I haven't reached it yet. I am knackered now so am signing off but treating patients now is not the same as hoping to run a clinical trial later.
  16. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    I think the issue is they have one side of the storie. The questions u have noted are all very good and they should have asked dr K those questions before bagging the crap out of him and everyone having anything to do with it. There is alot about the whole situation we just dont know about.

    I would say the author is the one jumping the gun without looking into it in any sort of depth??
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  17. ukxmrv

    ukxmrv Senior Member

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    I'm not sure what you mean by "promoting" Rituximab Firestormm in regards to Dr K?

    He's being chased by CFS patients from all over the world who are hoping to get treated with the drugs. I've spoken to a few of his current patients.
  18. Firestormm

    Firestormm Senior Member

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    I guess that is where my concerns lie also. Why is Koglenik treating patients with Rituximab at this point when others are saying 'Wait' for clinical trials?

    Again. He may have very good reasons for doing so - I'd like to hear from him if that is the case. It may be that these patients are enrolled in a study - if so why are they being charged (allegedly) so much money - or any money - and why hasn't the study been registered (allegedly it hasn't)?

    UKXMRV - I think that highlights my concerns. To answer you directly - why are patients 'chasing' Dr Kogelnik and no other doctor? What is he saying to attract them to his clinic from afar afield as Norway and Canada (at least)?

    I presume his comments in the Norway press about a 'trial' have something to do with it. I don't know. I am asking. I am not comfortable personally with the kind of expenditure being made by desperate (not necessarily ill-informed or suggestible) patients to seek a treatment that may not treat anything that they have - and may indeed leave them with long term health issues over and above the ones they have now.
    barbc56 likes this.
  19. Firestormm

    Firestormm Senior Member

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  20. Roy S

    Roy S former DC ME/CFS lobbyist

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    A recent thread got into the relevant subject of patronization but was locked soon after. I will exercise discretion here.
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