1. Patients launch $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
    Check out the website, Facebook and Twitter. Join in donate and spread the word!
Ergonomics and ME/CFS: Have You Hurt Yourself Without Knowing It?
Having a chronic illness like ME/CFS can make it hard to avoid problems that come from bad ergonomics. Jody Smith has learned some lessons the hard way ...
Discuss the article on the Forums.

SBM: Kogelnik, Rituximab and CFS: Jumping the gun

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

  1. JayS

    JayS

    Messages:
    77
    Likes:
    75
    You spoke negatively of Ampligen, as experimental. If this was outside of a clinical trial, then I would agree with your tone. If it was in a clinical trial, then, yes, it was experimental; but if not for clinical trials, we wouldn't have drug approval, would we? Every drug that's come through the approval process has been considered experimental prior to approval, so I think your characterization is kind of out of context.

    If Ampligen has ever been used outside of a clinical trial, I'm curious about it. Unlike Rituximab, Ampligen has not received approval for anything, so the loophole of 'off-label' use would not apply. Correct?

    There is one major issue that doesn't get mentioned enough: we hear calls for more research on so many seemingly promising findings...but, as we know, ME/CFS doesn't get much funding. Now, I don't view Ampligen approval as being a simple yes or no issue; it doesn't work for a lot of people, and the CDC tells us there are as many as 4 million people with "CFS." So, if Ampligen is approved, that's a signal to doctors who know nothing about ME to consider prescribing what would be, with much fanfare, the only drug approved to treat this "CFS" condition. Unless I'm mistaken, this drug is seen to be effective in a subgroup of a fairly strict criteria such as CCC. Broaden that criteria to Fukuda, and that's a whole other conversation. Make it 'Revised Fukuda' or 'Empirical' or whatever it was the CDC used to come up with the 2.54% number, and...I can't get behind that. I do think Hemispherix was fairly strict about the cohorts in the trials, but who knows what could happen later.

    On the other hand, I have seen an ME patient in a major crash during a period where they had come off of Ampligen...and the same patient not long afterward having come back to life. This patient is of course not the only one who responds well to this drug. What happens to these patients? Will they even be allowed access under 'compassionate use' or some such?

    The larger point, though, is, who's going to fund this research? Maybe Fluge & Mella get funded...maybe they don't. We sure heard a lot immediately following publication about how the companies that owned the rights to the drugs were not interested in funding a trial (and nobody else has seen fit to, yet, either). The FDA panel wants to see more research on Ampligen? This is hardly an unreasonable position, but...what research? There was no funding for Ampligen to begin with. The NIH? I don't expect to see them fund trials for Ampligen or Rituximab. Maybe someday they will, but now? No.

    It's easy for medical authorities to call for 'more research.' It's especially easy because it is the correct call. But in this case the correct call is not necessarily the right thing to do.

    I will not argue against the issues raised with these drugs. I will say that it is quite unreasonable to expect people who have been waiting for decades to continue waiting for research that is unlikely to be funded anytime soon. If Kogelnik is prescribing off-label, and that muddies the waters, makes it difficult to interpret research later on...what research. When?

    No research. Not anytime soon. I suggest that letting people suffer indefinitely is a far worse outcome than experimenting with a drug off-label.
     
    NK17 and Valentijn like this.
  2. Firestormm

    Firestormm Guest

    Messages:
    5,824
    Likes:
    5,976
    Cornwall England
    Hi Jay,

    To me 'experimental' applies to Ampligen because it has never been approved for anything. It applies to Rituximab because although this drug is approved (and has been for some time I understand), it is used to treat lymphoma's and Rheumatoid Arthiritis - to name but two - by way of destroying abnormal/dysfunctional B-cells in the hope (I presume) that new cells will not carry the cancer or by destroying those B-cells 'infected' it will leave a much reduced disease.

    However, there has been no science forthcoming that can say the same thing about ME. We do not have abnormal or dysfunctional B-cells. There has been scant science published that even hints at this being the case. Therefore it seems rather over-the-top to me to even begin considering destroying B-cells - vital for immune defence amongst other things - before the science concludes we are similarly affected (as per cancer or arthritis).

    Therefore in the treatment of ME, Rituximab is 'experimental' and I would argue is more potentially dangerous than Ampligen as a result given what this drug actually does to the system and that it is being prescribed largely in the dark.

    That doesn't mean that doctors who are prescribing it are wrong or should be condemned. Who am I to do such a thing? That's up to others to decide. We've covered I think the use of the terms 'pilot study' and 'off-label' and 'open trial'. All of these may be perfectly valid means of prescribing - and charging - Rituximab for patients with ME: but it sits ill with me.

    So where is the funding for more research to come from? You raise some good points. With Ampligen it's up to Hemispherex to 'put their money where their mouths are'. Patients anecdotes count for little I am afraid and Hemispherex were wrong if they hoped this would help sway the approval committee. But we shall see. Final approval is due next week I think.

    This company has the money to complete a more thorough clinical trial. They certainly raised enough of it off the back of hyped speculation with the stock price. Indeed one might say they made a killing off of the hope inspired by their own words. They are being sued for this but I doubt if it will be successful.

    It could be that this particular source of funds - $8 million from memory - will be used to pay down debt or to help pay those bonuses we heard about recently. I am being unduly unfair probably. But it could be that this money will be used to finance a clinical trial. Hemispherex are Ampligen. They have one horse in the race and they either cut and run or they 'go for it'. We shall have to wait and see. As per usual, patient feelings are seemingly at the bottom of commercial considerations.

    Rituximab funding from a government source seems unlikely, except perhaps in Norway. There is some confusion over there however, on my part probably. Recently we heard that whilst the government had 'set aside' funding, they didn't have the money available at the moment but that it might be found in due course. Again we wait.

    In America, funding will only come I suspect from non-profit/private sources. Probably not the drug company - due to patent but see above blog re: MS and use of next generation Rituximab. OMI? Well they are new and without funding - so full of good intent but lacking in substance.

    In the UK I am aware that the ME Association - to name but one possible future source - have been trying to rouse some interest from clinicians for example who might be willing to conduct a trial but to little avail at present. They cannot provide the full funding - I think it was envisaged to be around £250,000. But the MEA are willing to co-fund if partners can be found.

    If research goes off 'half-cocked' it will not help our cause. We should be demanding the best research possible and not more 'off-label' or 'open-trial' studies where patients themselves are charged for the privilege. There are no guarantees of anything - no guarantee that this drug will help and no guarantee that it won't leave you feeling worse.

    What sort of environment is that for anyone in our community to have to face? We know that this condition - whatever it is - appears to affect our immune capabilities. That we have trouble managing a viral infection. Not all the time but sometimes. Some of us are forced on this journey because of an immune trigger. Some are not.

    I want to know WHY Rituximab is supposed to be effective. As well as wanting to know more about HOW it is supposedly effective. Because at the moment - we know very little indeed and certainly not enough - in my view - to see US or UK government bodies releasing funds for clinical trials or even for research into ME and B-cells unless through a more general route i.e. studying ME and the immune system.

    It isn't satisfactory but neither are poor attempts to 'jump the gun' either. If indeed that is what has happened. It was a good debate to have I think and I hope - in Kogelnik's case - that as patients we get to hear more concrete thoughts from him about all of this. A published paper would be nice.
     
  3. alex3619

    alex3619 Senior Member

    Messages:
    7,404
    Likes:
    11,810
    Logan, Queensland, Australia
    There is evidence that we tend to have a Th2 immune bias. There is evidence of autoantibodies, and last year it was shown we probably have a high autoantibody load, just not in one specific autoantibody. We also have cytokine abnormalities that might be B cell related. In addition many of our B cells are immature - they are younger than they should be. These are all B cell related.

    That last one is a smoking gun to me. If we have more naive B cells then I want to know why. If on the other hand we have immature B cell clones, I want to know why. Something is wrong with our B cells. If this science is replicated a third time then we can be fairly sure of this, though I do not know if the first time it was shown was published - that was the WPI during the XMRV debate.

    If B cells are dying either there is a process killing them, or a pathogen killing them. In light of the Rituximab findings I think a pathogen is much more likely, but I cannot be sure.

    We all agree we need more science on this. In some ways this debate has no point, nothing that is being done is illegal, the doctor wants it, the patients want it, and it benefits the community. The downside so far is all unrealized "what if" scenarios.

    Proper phase 3 clinical trials will answer many of these questions. The final results from the phase 2 trials are due later this year: they have more to say.

    There are very few drugs that work well on ME or CFS, and none currently given full approval. The results from Rituximab, select antivirals and even Ampligen make CBT/GET look like a joke, and seem to be far less likely to hurt us. In fact I would say that these treatments (perhaps not including Ampligen) are up to a full order of magnitude better in results than CBT/GET in select patients. I just wish more outcomes were measured objectively instead of subjectively using questionairres. Objective outcomes are needed in biomedical studies as much as they are needed in psychopsychiatric studies.
     
    NK17, penny, SOC and 1 other person like this.
  4. Valentijn

    Valentijn Activity Level: 3

    Messages:
    6,481
    Likes:
    9,572
    Amersfoort, Netherlands
    Right, so all drugs used off label are experimental? Just like the drugs that you take for your symptoms? There is no distinction between "off-label" and "well this problem is sort of similar" - if it's not on-label, it's off-label. There is no middle ground, despite your attempts to create one to justify attacking an approved drug that you don't like people to use off-label while defending approved drugs that you like to use off-label.

    You have been repeatedly quoted and cited a study showing that ME patients have abnormal B cell populations. Why do you continue to deny its existence? Is there a problem with the study that causes you to doubt its reliability? But here it is again, and a couple others:
    Safety is a completely distinct issue from efficacy. It may not have been proven as effective for ME as it has been for cancer or RA, but it has been proven pretty safe.

    Too bad. Just like in the legal arena, the answer to "why" is not needed. It's never known for most drugs, and Rituximab might not be any different. Knowing that it depletes B cells puts Rituximab yards ahead of other drugs (some of which you're taking) already. If it's safe, and somewhat effective, then that's good enough.
     
    NK17, penny and SOC like this.
  5. user9876

    user9876 Senior Member

    Messages:
    770
    Likes:
    1,863
    I don't think they know how Rituximab works for RA but it does in some cases. The theory I have read is not about killing disfunctional b-cells but, as I would understand it, is about the immune cycle that includes b cells signalling to T cells that do the damage. My interpretation would be that if you shock the cycle it at least temporarily reaches a different equlibrium.

    The poin is that with RA the mechanism is not understood but it is used as a treatment.
     
    NK17, penny and Valentijn like this.
  6. Firestormm

    Firestormm Guest

    Messages:
    5,824
    Likes:
    5,976
    Cornwall England
    I think we are at crossed purposes here perhaps. You see I am hearing Rituximab as being something that addresses a possible mechanism that is in part or in whole responsible for ME. In that I think other 'off label' prescriptions are indeed different. They do not purport to address whatever is integrally 'wrong' with patients with ME i.e. the aetiology or cause.

    They are symptomatic in addressing or relieving such things as 'pain' either general or muscular or nervous system associated, for example. Other 'off-label' prescriptions are perhaps prescribed to address symptoms associated with other - less general - symptoms that may or may not be part and parcel of some people's ME. For example, my epilepsy medication. That was prescribed following - from memory - EEG investigations as well as observed 'fitting' and periods of unconsciousness.

    I am not comfortable with the prescribing of Rituximab outside of clinical trial. It is 'sold' as addressing something relevant to people with ME without us knowing what exactly that might be and how relevant it is to those being prescribed this drug. It is a drug that is likened to the effects of receiving 'chemotherapy' even if it does appear (to my layman's eyes) as being more specific in it's targeting i.e. B-cells and not all cells.

    How does anyone determine which patients are suitable? How did they for Ampligen come to that? All that I can glean is that they ensured to the best of their ability that these patients had ME. As we all know there is no test for this condition. I would like to hear that they at least took steps to demonstrate that each patients B-cells were in some way damaged. But I have heard nothing to that effect.

    I would like to see a paper demonstrating the extent to which our B-cells (or a sub-set of us) are damaged, or dysfunctional. A paper that has been or is likely to be accepted. I do appreciate that things don't always work like this and that a clinical trial of a known drug (or new drug) can often 'show the way' before the science has demonstrated how or why.

    It doesn't stop me asking.
     
  7. orion

    orion Senior Member

    Messages:
    101
    Likes:
    64
    UK
    This thread is going round in circles. We all know that taking prescription drugs involves a degree of risk, and that taking drugs off-label is (as a general rule) even riskier. That's a given. The real issue is whether or not the risk is worth it, and surely that's a decision that can only be made by the individuals concerned.

    Can we at least agree that patients who are strongly motivated to try drugs off-label (obviously at their own risk and expense) should not be prevented from doing so?
     
    penny, SOC and Valentijn like this.
  8. Firestormm

    Firestormm Guest

    Messages:
    5,824
    Likes:
    5,976
    Cornwall England
    I think there has been some confusion (on my part) with the term 'off-label'. Where a drug - that is approved - is used to treat symptoms and prescribed by a doctor I don't regard that as 'off-label'.

    The term implies for me that you are using a drug that is purposefully designed to treat a disease other than the one that you are believed to have. I might be wrong, but wanted to just raise it.

    Also, Rituximab - as I think I mentioned before - is used in Rheumatoid Arthritis only in severe cases and when other drugs have failed to work.

    As you say Orion, patients can do what they please. They pay for it. They accept the risks. There are no guarantees. If what the physician tells them appears to be perfectly reasonable - in terms of expectation and risk - then they take it on themselves.

    If it goes wrong then I am sure they will simply shrug and say 'well it's my own fault'.

    Orion there is a clear difference between being prescribed a painkiller that is approved and recognised for general pain relief and running the risk of side effects and that the drug might not work, than being hit with Rituximab as well as a bloody great bill.

    Maybe these 'open-label' studies are necessary. I don't understand how they work. Maybe I am asking for and wanting an 'ideal world' here but I don't see why we should continue to be treated as guinea pigs to the extent that we have been.

    Why hasn't Kogelnik registered any trial? He is obviously happy to charge and prescribe this drug for his patients now and I would simply like to understand why because this information is not available to any of us.

    I don't know. There's probably a difference between the US and UK in this matter of 'off-label' stuff. I mean some were prescribed anti-retrovirals after all and it doesn't appear to have done them any harm (that we know of) but in the UK I would not imagine that any GP would have done likewise or with Rituximab for that matter.

    Maybe you see this as a failing on the UK's part and a plus for the US? I just don't agree at this point not without more information.
     
  9. Valentijn

    Valentijn Activity Level: 3

    Messages:
    6,481
    Likes:
    9,572
    Amersfoort, Netherlands
    Your interpretation is incorrect. Drugs are approved for a very narrow on-label use, basically the use that the drug was given for in the trials which were submitted when the drug makers sought approval for that drug. An example is one of your drugs approved for spasticity which you are using for spasms. Even though it is a drug that helps with spasticity, and spasms might have a similar underlying mechanism, they are clearly different symptoms - hence using it for spasms is off-label.

    Because drugs are approved for such extremely limited on-label use, there's a very practical need to use those drugs in other manners. This is how the system is meant to operate, so long as the drug company is not actively advertising their drug for off-label uses. It's generally sensible to use this approach because testing a drug for every likely use is financially impossible, and because the trials for limited uses are sufficient in establishing a safety profile for the drug.
    We aren't talking about pain killers. Pain killers are always for pain, hence pretty much always on-label when used for pain. The subject (I thought) was off-label use. I'm also not sure what you mean by "being hit with Rituximab". Plenty of us have been "hit" by drugs (antidepressants) commonly prescribed to ME/CFS patients, and those are usually being prescribed with far less indication that they are appropriate.
    When being offered options such as Rituximab, we're being treated as human beings (for a change), capable of making choices and having our symptoms recognized as physiological and highly disabling. I don't see how being given a choice equates to being treated like a test animal.
    I doubt there's much difference, seeing as you're in the UK and taking several off-label drugs. I think the problem is with your assumption that drugs are rarely prescribed off-label, or that there is some process in place assuring that your off-label drugs are somehow safer and more appropriate than other off-label drugs. There isn't. As in the case of Rituximab and ME, there are probably limited studies done showing that those drugs might be useful. It's unlikely that there is more evidence supporting the off-label use of your drugs than there is already in the case of Riuximab for ME - if there were, the drug makers would have submitted it to have additional on-label uses approved for those drugs.

    Maybe that is a bit scary for some people, but that's how things work. It's unlikely to change either, unless a very cheap way to conduct a huge range of trials suddenly appears on the horizon.
     
    NK17, penny and SOC like this.
  10. In Vitro Infidelium

    In Vitro Infidelium Guest

    Messages:
    646
    Likes:
    280
    I think that's likely to cause consternation to many defence lawyers, who seem to have a general belief that part of the burden on the prosecution is presentation of 'motive', though it would certaily help fill up prisons if just anyone could be collared for a crime on the basis of just being in the wrong place at the wrong time. Correlation implies causation as a legal doctrine ?
    It is certainly true that in the case of medicine, a treatment can have facility without the action of the treatment being understood, however where adverse reactions can have serious consequences, the assessment of 'facility' requires more than mere acceptance of a level of impact no greater than that of placebo. And to forstall the argument 'but Mella and Fluge's results were better than placebo' - lets be clear, from the perspective of an individual patient there is no capacity to divine whether or not perceived improvements are plecebo mediated. Casting the argument in terms of 'patient's rights' is perverse, the right to purchase may exist but that doesn't obviate the duty of physicians to ensure patients are able to make informed choices and to take reasonable steps to ensure that treatment delivery is based on more than partial science and leaps of faith.

    IVI
     
  11. Valentijn

    Valentijn Activity Level: 3

    Messages:
    6,481
    Likes:
    9,572
    Amersfoort, Netherlands
    Despite what is seen on TV, motive is almost always irrelevant - it's just shown on TV because the viewers want a good story. The criminal usually has to act deliberately, but motive is almost never an element of a crime. What matters in a court is that the person did the act - just as "why" is rarely shown to a satisfactory level when it comes to the effect drugs have.
    There is already a great deal of data available regarding adverse events, from trials involving cancer patients. It's very unlikely that Rituximab would be significantly more dangerous for ME patients than it is for cancer patients. It's also used off-label in a wide range of auto-immune disorders.
    I don't believe anyone has accused any doctor of failing to inform their patients of the risks of taking Rituximab. Of course the doctors have that duty, as does every doctor regarding the use of any drug or other treatment. And the "partial science and leaps of faith" are no more applicable to Rituximab than they are to thousands of other drugs commonly prescribed off-label without any objection by "skeptics".
     
    NK17 and penny like this.
  12. barbc56

    barbc56 Senior Member

    Messages:
    1,529
    Likes:
    934
    Whatever happened to means, motive and opportunity with intent thrown in??? I thought all were important. I should know as I have vast experience reading mystery, crime novels as well as watching every episode of every season of the american TV series Law and Order. I mean who needs a law degree?:D

    Barb
     
  13. barbc56

    barbc56 Senior Member

    Messages:
    1,529
    Likes:
    934
    I think that has been stated from the beginning of this thread. It's not about these issues per se but this particular situation and the ethics/soundness behind doctor's prescribing the medication Rituximab on the basis of what we scientifically know about the drug. There are also some gray areas that make this topic very complicated.

    Barb
     
  14. Whit

    Whit Senior Member

    Messages:
    253
    Likes:
    232
    Bay Area
    Barb, what world do you live in? Seriously, do you live in a world where perfect studies about CFS are funded, and there are a whole array of great treatments to prescribe? The reality we are presented with is dismal. Doctors are confronted with this reality. They do the best they can. And honestly, you don't know what you're talking about with regards to Rituxan, the Norwegian studies, or Kogelnik. He knows vastly more than you do, and he is in contact and working with the Norwegian researchers. You're making serious accusations based on google searches. It's not wise.

    I know that things are not perfect, and no doctor is, but I very strongly disagree with almost everything you have posted here. Hopefully I will have enough energy to write up a more thorough response at some point.
     
    NK17, penny, Valentijn and 1 other person like this.
  15. Whit

    Whit Senior Member

    Messages:
    253
    Likes:
    232
    Bay Area
    No, it's not a matter of perspective. It's a matter of being informed about the facts and the truth, and also being realistic about what is actually possible. Do you have any idea how hard Andy is trying to put together a large formal study on Rituxan? It's not that easy. It might not even be possible.

    But if it is so easy as you make it out to be, why don't you make some calls and make it happen? I'm sure Andy would be grateful.
     
    NK17, penny and Kati like this.
  16. barbc56

    barbc56 Senior Member

    Messages:
    1,529
    Likes:
    934
    What makes you think that I am only basing my opinions and accusations from Google? ;)
    Barb

    ETA Our posts passed while I was editing. I won't get into a debate about perspective at this time.
     
  17. JayS

    JayS

    Messages:
    77
    Likes:
    75
    Maybe for you. For me it's about the gray areas. They don't touch ME/CFS with a ten-foot pole unless they can grandstand on someone doing something potentially wrong or unethical, in this case Kogelnik. Why? Well, they've never, ever reversed their long-held position that CFS is somatization, and when comment threads are steered in a direction where this view is challenged, it is never abandoned. The disease is never actually commented on, only activities by those attempting to treat it. They loathe NCCAM, but it was co-founded by Stephen Straus, whose name they almost never mention.

    Given that Straus was, outside of Wessely, the single most influential individual in framing CFS as a psychiatric disorder, it actually makes sense they'd resist mentioning him, lest they have to explain how someone who was so spectacularly wrong about CAM could have possibly been so right when it comes to a condition there's so much controversy about.

    The SBM people have been asked to apply the skeptical eye they wield with such determination at PACE, but...crickets. If it matters to them that the Gupta Programme is being studied with NIH funds for CFS at the Mayo Clinic (or the Lightning Process with SMILE), they haven't seen fit to mention it. Their pals ran with the Wessely 'death threats' story uncritically, accepting that since we reject CBT and GET, which happen to be the only treatments proven to be effective and safe, we are impeding the scientific process. The idea that we pose a threat greater than a war zone or animal rights terrorists was not questioned. And, needless to say, if they saw that Vincent Racaniello's Virology Blog ran a long piece by David Tuller on CFS and the CDC, it was not worth mentioning.

    Their coverage of XMRV was centered mainly around the issue of patients taking antiretrovirals; no reason to address the possibility that if the retroviral hypothesis was valid, that perhaps this was actually a severe physical disease, and had been all along. The initial post on the topic seemed to ask that, since we know CFS to be somatization, why would anyone even be bothering to look for a virus.

    I do not share the optimism that Norway, or anyone else, will fund a proper Rituximab trial. I'd love to be wrong about that, but in the meantime, what we are told is 'more research is needed' by people who either don't know or don't care that 'there is no funding for more research,' a situation that is unlikely to change anytime soon.

    I can't say that this, which is reality as far as I'm concerned, should permit Kogelnik, or anyone else, to operate in a way that would be considered unethical. I can say that this sort of unbelievably selective finger-pointing, while ignoring every other issue we deal with, every inequity, every insult, every painfully difficult hour of every day, leads me to not care that a focus on Kogelnik's foibles could/should be valid. I don't accept that this is about what they say it's about. This is about all of those little things that they consistently ignore. This is about this disease that society essentially doesn't care about, that remains consistently un-funded, the one that renders us unable to leave our beds. The one they never write about. Ever.
     
    NK17 and penny like this.
  18. Kati

    Kati Patient in training

    Messages:
    2,052
    Likes:
    1,541
    Donation made for the work of OMI-Merit. OMI's research program is bold, forward thinking and desperately needed. All patients from around the world will benefit.

    For those who want Rituximab trials to happen, and more (biobank, other drug trials, pathophysiology of ME etc...) donate here: http://openmedicineinstitute.org/
    Only through research can we move forward. OMI has all the ingredients to make it happen, but they need financial support.
     
    NK17, penny, WillowJ and 2 others like this.
  19. In Vitro Infidelium

    In Vitro Infidelium Guest

    Messages:
    646
    Likes:
    280
    You appear to be arguing for a legal process that only recognises actus rea and denies any role for mens rea (yes motive isn’t precisely mens rea but ‘motive’ is how the defence frequently approaches the issue of mens rea). Anyway it’s your analogy and ultimately science is not forensic, other than science may be put into service of forensic purpose. I guess one could also say that science is not medicine, other than science may be put into service of medical purpose, but I think that reveals the backwards fallacy of your argument which would reduce medical practice from the application of science, to a pre scientific notion of “correlation implies causation”.

    Not being able to show ‘why’ in science raises the bar for how much more relevant is the ‘how’. To use your criminal analogy – the coincidence that a defendant was present contemporarily with the enactment of a crime, and without any basis for the defendant to be motivated to commit the crime (and therefore no assessable mens rea), there needs to be demonstration of how the defendant actually committed the crime. Of course it is a persistent failing of many legal systems that being in the wrong place at the wrong time ( the drug analogy reverses criminal malice to pharmacological benefit) ensures innocent people are summarily found guilty by dint of the “correlation implies causation” fallacy. I can’t see any use in extending a principle legal failing to medical practice.
    On what basis is probability of safety in M.E/CFS to be derived from safety in Cancer ? Which cancer ?, which demographic ? And safety isn’t the only issue – risk/benefit judgements require some appreciation of the probability of potential outcomes. For example a mild improvement in 1 in a 100 patients, matched against possible permanent impairment would probably put most patients off a particular intervention. The Mella and Fluge study, just isn’t adequate to guide patients in terms of risk/benefit. Yes ‘open label’ studies of Rituximab in different auto-immune disorders present some interesting data http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3002645/ but participant numbers are low and levels of impairment are often profound .
    And the risks are ? All that can be talked about are ‘known’ risks, and as none of the prescribing doctors have published a protocol it’s impossible to know what discussion of known risks is taking place. More concerning still are the levels of monitoring and co-operation with primary care providers, given how poor the PC support for M.E/CFS patients is, and at least in the case of Kogelnik patients are travelling significant distances monitoring during treatment seems likely to be problematic.

    I don’t understand the appeal to ‘other crap happens’, if poor prescribing practices allow the inappropriate medication of patients then it’s a systemic failing, which can’t logically mean that another bad decision can be excused as a good one.

    IVI
     
  20. Snow Leopard

    Snow Leopard Senior Member

    Messages:
    2,362
    Likes:
    1,936
    Australia
    Sometimes doing nothing does more harm than doing something. Is this the case for Rituximab?
     
    SOC, penny and Valentijn like this.

See more popular forum discussions.

Share This Page