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SBM: Kogelnik, Rituximab and CFS: Jumping the gun

Firestormm

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

Now that the XMRV myth has been put to rest, patients with Chronic Fatigue Syndrome (CFS) are no longer jumping the gun to demand anti-retroviral treatments. But they are jumping the gun in new ways, based on very preliminary data coming out of Norway.

A correspondent in Norway wrote to tell me patients from Norway with myalgic encephalitis/chronic fatigue syndrome (ME/CFS) are travelling to the US to have Dr. Andreas Kogelnik in San Francisco treat them with IV infusions of rituximab, apparently to no avail. A course of treatment costs over $6000, not to speak of travel and other expenses....

What is Rituximab?

It’s a chimeric monoclonal antibody against the protein CD20, and it destroys B cells. It is used to treat diseases with excessive, overactive, or dysfunctional B cells such as some lymphomas, leukemias, transplant rejection, and some autoimmune disorders, notably rheumatoid arthritis.

It is expensive (several thousands of dollars per infusion), must be given IV, and can cause serious adverse effects including infusion reactions, reactivation of infections, and cardiac arrest.
Using it for CFS is not based on any clear scientific rationale, but only on a few observations of patient improvement and on speculation about a possible cause of CFS that might explain the observations. It has certainly not been established that CFS symptoms can be attributed to B cell abnormalities.

A Patient’s Story

A blogger in Canada has chronicled her experience at great length. She has been travelling to San Francisco for treatments, and she believes she is enrolled in a pilot study. A quote from her blog:

The treatments I would receive are not considered a clinical trial, but a pilot study because clinical trials are tightly regulated and operated. It needs a lot of work from investigators to establish guidelines and procedures, obtain approval from ethic boards, etc.​

When questioned, she elaborated:

a pilot study is not a registered clinical trial. It’s a one person trial. It gives the opportunity for the physician and researcher to gain experience with the drug and to refine the protocol associated with its administration. The goal for this is to move forward with a very formal and well controlled clinical trial.​

She is hopelessly confused about what constitutes a pilot study. I can’t tell whether she was misinformed or simply misunderstood what she was told, but it raises questions about informed consent. She had worked as a chemo nurse and had been involved in phase 1 studies of new drugs so she should know better....

[More from the Canadian blogger's experience followed]

...

What Is the Evidence?

An initial observation. Fluge and Mella observed that a patient with CFS had an unexpected, marked recovery of CFS symptoms lasting for 5 months during and after cytotoxic chemotherapy for Hodgkin’s disease. They reasoned that the improvement was probably related to her treatment with methotrexate, a drug known to induce immunomodulation in part through B-cell depletion.

A small case series. So they decided to try depleting B-cells with rituximab in the original patient plus two others. This was published as a case series in 2009. The treatment was 2 IV infusions given 2 weeks apart, with a maximum dose of 1000mg. 2 of the 3 patients were also given oral methotrexate for recurrent symptoms.

All three patients, with 7–10 years of CFS disease duration, had substantial relief of all symptoms related to CFS after rituximab intervention. Patients 1 and 2 had a marked symptom improvement after approximately 6 to 12–16 weeks, followed by slowly increasing symptoms (yet still a benefit 6 months after treatment). Patient 3 had slight symptom improvement from 6 to 26 weeks after treatment, thereafter a major recovery of all symptoms lasting until 40 weeks after treatment, followed by a gradual worsening the following month.​

One randomized controlled trial. Their next step was to do a randomized, double-blind, placebo-controlled comparison of rituximab to IV saline. 2 infusions were given 2 weeks apart to 30 patients. All patients were pre-treated with cetirizine, paracetamol and dexamethasone to minimize the risk of reactions.

They are calling it a positive study; but for their primary end-point (effect on self-reported CFS symptoms three months after intervention) the results were actually negative.

They continued to observe the patients for secondary endpoints, and other secondary endpoints were added to the protocol mid-stream. They found a significant difference between the groups at 6-10 months after treatment.

They characterized this as:

significant, though generally transient clinical responses, with CFS symptom improvement in two thirds of the included patients.​

Of the patients on rituximab, 10 had a major or moderate response lasting from 8–44 weeks; the other third failed to respond. Two patients in the placebo group had a major or moderate response.

The study design could have been better. There were some significant differences between the patient characteristics in the two groups, and it doesn’t appear that they questioned patients to see if they could guess which group they were in (i.e., whether blinding was adequate).

More studies in progress. They announced:

Based on new pilot patient experiences [what does this mean? Are they, too, confusing pilot studies with anecdotal evidence?] we have now started two new open-label phase-II studies investigating Rituximab treatment with two infusions two weeks apart (as in the present study) followed by maintenance Rituximab infusions at 3, 6, 10 and 15 months, to further explore this treatment principle in CFS (ClinicalTrials.gov, NCT01156909 and NCT01156922).​

Strangely, both of these studies are open-label, with no control group and no blinding. What were they thinking?

What Is Kogelnik Doing?

Kogelnik founded the Open Medicine Institute to facilitate electronic information sharing in a community-based process. It is crowd-sourcing private funds. It has great plans for research, but as yet no studies have been registered at ClinicalTrials.gov.

As far as I have been able to determine, he is offering individual patients treatment outside of any legitimate study. I don’t know how he is representing this to his patients, but at least one medically trained patient believed she was participating in a pilot study Kogelnik was doing in collaboration with researchers in Norway. I have no way of knowing whether the misunderstanding was on her part or his.

Some of this reminds me of Burzynski’s deceptive tactics, but Kugelnik is no Burzynski. I’m willing to believe he is sincerely trying to help patients who have no other options. But I think he’s on the wrong track. The way to really help these patients is to insist on providing the drug only in the context of well-designed clinical studies to establish once and for all whether rituximab treatment is effective. Jumping the gun is not scientifically or ethically justified.

Don’t expect anyone to try to stop him. Rituximab is an FDA-approved drug for other indications, and it is not illegal to prescribe the drug off-label. Offering experimental treatments to patients is not illegal. Medical boards have disciplinary power: the infamous Dr. Mark Geier, chemical castrator of autistic children, lost his license for “almost total disregard of basic medical and ethical standards,” but that kind of medical board action is the exception to the rule.

Similar malfeasance (Dr. William Rea, for example) has typically been ignored or punished only with a mild slap on the wrist. Even Burzynski has not lost his license. In the absence of regulatory action, the only remedy would be a lawsuit if a patient died or was seriously harmed by the treatments.

Conclusion

So basically, the evidence consists of one case report (involving a different drug!), a case series of 3, and one preliminary controlled study with 30 patients showing a 2/3 response that was delayed and transient.

Preliminary studies serve to justify further studies but they are not sufficient to justify forging ahead with offering the treatments in clinical practice. All too often, attempts to replicate preliminary studies fail, and initially promising results are discredited by larger, better studies. XMRV was a prime example of that.

The protocol in the studies was 2 IV infusions 2 weeks apart. The protocol that Kogelnik is using (treatments 2 weeks apart, then at 8, 24, 44 and 60 weeks) doesn’t correspond to the published study or even to the Norwegian studies in progress.

In my opinion, what he is doing is not based on acceptable evidence and is not ethical. He is indulging in irresponsible, uncontrolled experimentation. He is knocking out a vital part of his patients’ immune systems (B cells produce antibodies to fight off infections) with little understanding of what he is accomplishing, of whether it addresses some basic underlying causal mechanism of CFS, or of what the possible long-term consequences might be.

By jumping the gun he is putting patients at risk; exposing them to considerable cost, discomfort, and inconvenience; and by running around the track prematurely by himself, he is missing out on the real race to understand and treat patients diagnosed with CFS/ME/CFIDS.

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.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
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.
 

heapsreal

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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??
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
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??

Not a babbler, but someone ignoring babble. However she is a retired ex-military MD.
 

free at last

Senior Member
Messages
697
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 ?
 

Firestormm

Senior Member
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Location
Cornwall England
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.
 

Firestormm

Senior Member
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# PernilleNon 09 Jan 2013 at 2:52 pm

Som update about the Norwegian research: Fluge and Mella’s application to the Norwegian research board for 9 million NOK (about 2 million dollars) funding for their RCT was turned down (… along with 400 other good applicants, so this is hardly discrimination against ME-patients). But the Norwegian Secretary of health has given then 4 million NOK, and there’s an ongoing crowdfunding project, so they will probably be able to start their RCT.

@Irene: Kogelnik has said several times, e.g. to a Norwegian newspaper, that he has a project. He sometimes calls it a pilot study, sometimes a case-by-case study. He has also said, or implied, that he is collaborating with Fluge and Mella about it. According to you there’s no project but off-label treatment. It’s all rather confusing.

Perhaps someone could ask Kogelnik to comment? Harriet Hall, I suppose you’ve tried asking him?

About IreneF, I think many of you are confusing her with Kati, whose blog Hall quotes in her article. Irene has tried to say several times she doesn’t have a blog, but several people here keep criticising her for what she allegedly writes in her blog.What about believing what se says, and checking your facts?

Regards

Pernille Nylehn

Norway
 

heapsreal

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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.
 
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15,786
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?

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.
 
Messages
15,786
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.

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.
 

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)
 

Firestormm

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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.

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.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
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)

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.
 

heapsreal

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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.

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??
 

Firestormm

Senior Member
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  1. PernilleNon 10 Jan 2013 at 4:44 pm
    IreneF says:
    “Someone else is worried because a CFS patient in Norway is flying to California for treatment. This may reflect more on Norwegian attitudes than anything else”
    That’s me. But you left out a rather important point in my worries: These patients are paying 8000$ per treatment, plus travel and lodging. One of them has spent more than 40,000$ so far.
    That worries me. Perhaps it’s a Norwegian attitude to be worried – no, angry – when very sick patients are charged that kind of money for taking part in a so called study (yes, they are told they are) with a treatment that is in practice experimental. If that’s a typical Norwegian attitude, I can’t say I’m sorry about being Norwegian.
    As for the Norwegian doctors who discovered that Rituximab may be useful for some ME patients: They have said very clearly that the drug should not be used outside clinical studies. In other words: Kogelnik is doing exactly what these two very serious and dedicated doctors ask us not to. If you should pay heed to any Norwegian’s attitude, I think it should be to the only two people who have actually done proper research into Rituximab for CFS/ME. They are also oncologists, and have many years of experience with Rituximab (does Kogelnik have that kind of experience?).
    I must say Kogelnik has a lot of nerve going against their advice. I’m sure he means well and wants to help, but what he is doing is still wrong. And even though he has he the patients’ informed consent, he is still the doctor, and he is responsible for what he is doing. And he will be to blame if something goes wrong. Rituximab is a potent drug that can have very serious side effects. And we don’t know yet if CFS/ME patients will have different, or more serious, side effects than other patients. That’s one of the many things we need to find out from properly performed clinical trials.
    Regards
    Pernille Nylehn
    Norway

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.
 

Firestormm

Senior Member
Messages
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Location
Cornwall England
  1. # Harriet Hallon 10 Jan 2013 at 4:45 pm
    Irenef seems to understand what she is doing, and I did not “attack” her for her decision. I have no problem with patients trying experimental treatments with informed consent, and I understand the desperation. My problem is not with the patients but with doctors who encourage experimental treatments outside of clinical trials, especially when the rationale for the treatment is shaky, when the treatment is dangerous, and when the patients think they are in a clinical trial. I have tried to explain why I think that is short-sighted and only tends to delay proper research and the acceptance of its conclusions. Arguably, doctors who refuse to treat patients outside of clinical trials are acting in the ultimate best interest of all patients.
    At least one of Dr. Kogelnik’s patients believed she was participating in a pilot study, and in this interview
    Dr. Kogelnik says he is doing a “pilot” and empirically treating patients. No such study has been registered, and Irenef herself provides evidence that he is simply treating patients outside of any formal study. She is taking the drug with informed consent, but a legitimate pilot study would require IRB approval and a formal consent to the study protocol.
    And please note that no one can say that Ritux is implausible in terms of the pathophysiology of CFS, because we don’t understand that pathophysiology. But in my opinion, the quality and amount of evidence available so far for Ritux is not a plausible justification for treating patients.
 

Roy S

former DC ME/CFS lobbyist
Messages
1,376
Location
Illinois, USA
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.

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