Discussion in 'General ME/CFS News' started by Firestormm, Jan 13, 2013.
Because it's legal and because patients are making the informed choice to do it.
I'll be a little less discrete. Saying "ME patients shouldn't be condemned for choosing" but then saying doctors shouldn't be offering us this choice really is still paternalism. We should have the choice, and the doctors should be able to offer us the choice - the drug is relatively safe, we are extremely disabled in many cases, and we are mentally competent adults.
If people don't like having the option, then don't take it. I'm sick of hearing that doctors shouldn't offer me the option.
On the issue of the safety of rituximab in rheumatoid arthritis:
I doubt the same could be said for us if "3194 patients had received up to 17 GET courses over 9.5 years"! Personally, I am hesitant to try anything serious out of a fear of further reducing what little health I have left after previous unexpected mistakes, wasted expenses, and natural progressions, but I can understand the desperation that patients feel. My own amateurish hunch is that rituximab will become an important clue into the etiology and/or pathophysiology of ME/CFS rather than a first line treatment, although I think a larger RCT of rituximab for ME/CFS should be done ASAP.
They arent being charged that much, the person the article is written about has extra costs as she lives further away so extra costs involve travel and accommodation etc. if the person lived 2 streets away then the cost wouldnt be much more then other treatments especially with financial assistance schemes offered by pharma companies for ritux. Again the author is adding their own spin to make it sound more dramatic
That was my impression as well. I have read her blog and her posts here.
I think she was using the term "pilot " loosely to mean he was using this on a few patients, and if things worked out then he could go toward something formal.
1. as others said, they don't get this illness or they would cut her some slack re; the neuro cog issues
2. The main thing that I don't get is that doctors trying/using drugs off label in a clinical setting ( w/o a formal study) for illnesses that effective treatments are either non existent or the choices are not great is very very common.
--They generally ( at least it has been my experience) insist on informed consent from the patient/ and or the patients caregiver.
--They do this so they can figure out if this is an avenue to pursue further w/ "real" studies. and to offer relief for patients that can't wait for a formal study.
-- My doctors over the years have been very willing ( and yes they have included, a well respected academic who is always doing research and publishing on other topics, and a couple me/cfs research specialists, and my pcp) We, of course, way the pros and cons and do the homework.
-- One of the persons mentioned it was ok for other illnesses b/c people can die from their illnesses. again. they don't get this disease.
--I have taken countless meds -- some w/ very major potential SEs ( some which I experienced )--- w/ eyes wide open. as a guinea pig to see if it was worth giving to others/starting a bigger study. Prior to XMRV no one paid any attention to this sort of thing w/ ME/CFS.
-- which leads to the mention of those taking ARVs -- well some still are and are doing well on them. They have gone underground due to the harassment.
-- they specifically site "dangerous side effects of ritux and the absence of LT knowledge :
-again not understanding the illness.
-- they don't seem to really understanding ritux. I have spoken w/ rheumy who gives it and has given it and published for a dozen years. He thinks it will someday be standard care for RA it has done so well. He has not had any problems with toxicity/ SEs short or long term.
--- more common meds given for symptomatic treatment cause some very serious SEs in people with this illness due to medication and chemical sensitivities. Again. lack of understanding of this illness. For me, there is just as much risk , maybe greater, at taking certain classifications of meds.
3. the issue of "false hope" was brought up. First of all that is an oxymoron. I don't believe in false hope. false expectations yes. There is a difference.
And so what ? as if we are too frickin' fragile to handle disappointment. Sure. a treatment that doesn't turn out as we wanted. that's hard. not discounting that. But they don't realize what we deal with on a daily basis. some tough cookies around here ;-) That's up to us to accept the risk. No one is responsible for anyone else's feelings.
If you are getting excited about treatment you here someone else taking and it doesn't pan out. That's not the person who tried the med's responsibility ( or their doc's) It may be difficult for some to handle. and this may sound harsh. But that's life w/ this plague.
Being intentionally given false information and lead on by that is a different story and wrong for anyone w/ any illness.
4. A handfull of patients taking the med is not going to ruin a potential study base.( as was brought up) The cost of this drug has that taken care of. and btw : If someone wants to spend their money for a medication and it is available to them and legal then that's their business.
5. well my eyes are crossing so if I think of number 5 i'll get back to you : )
been falling asleep many times reading that article and this thread . time to crash.
ETA -- ok remembered as soon as posted :
cost to patients re if it is "experimental "
Do you know how much it cost to take ampligen ???
and even if they pay for the drug -- in that or any study. there are other costs in many many drug trials that participants absorb if the illness is not well funded.
and / or patient groups --- like the American Cancer Society sponsor research all the time.
i didn't get that arguement they had about patient groups paying for studies.
IT's done all the time.
I think the term is unbalanced journalism. It has an agenda, it is not about getting all sides of the story before being written. Thats presuming of course that it even qualifies as journalism.
Chemotherapy drugs can be very dangerous. It's a situation where you have to weigh the positives against the negatives.
Patients with rheumatic conditions are vigorously screened and then other medications with a better safety profile are tried first. Unfortunately, we can't do that for PWME as we don't know the subsets.
It's also a question of whether a real study is going on. If a person is in a credible study, I believe they are not allowed to speak of it until the study is finished. If I am not correct about that someone let me know.
While the institute itself may be a legitimate research facility, I don't know that much about it, Dr. Kogelnik appears to be skirting around the issue of ethical treatment and doesn't take into consideration the adage of "First do no harm."
I wonder if patients have to sign something saying they can't sue the doctor nor the clinic.
If someone wants to do this and has the money it's personal choice. But for me, there are just too many red flags for me to opt for this treatment. Same for Ampligen but that's another issue.
I think it's worth it to highlight the following from the article:
This issue reminds me of the (superficial) concerns over desperate long-term patients trying antiretrovirals during the XMRV saga while the CDC were doling out ARVs to healthy Africans at risk of HIV infection. A cursory review of the research suggests that rituximab is safe for RA, although this does not necessarily mean it is safe for ME/CFS.
Activity and exercise have been infamously known for decades to make ME/CFS patients worse temporarily, and there is no shortage of anecdotes about exercise, graded or otherwise, making patients worse in the long-term too. Meanwhile, thousands of patients received CBT/GET for ME/CFS long before adequate data on adverse effects was published, they were effectively guinea pigs in the experimental phase of clinical research and practice.
CBT/GET proponents claimed that post-exertional symptoms are not dangerous nor pathological, rejected a pathological activity ceiling, downplayed or dismissed multiple patient surveys reporting adverse effects, and openly promoted these therapies as inherently safe for over a decade (before the 2010s, the safety profile was loosely inferred from dropouts and group average scores in fatigue from low-quality evidence, and from the anecdotes of researchers).
The 2007 NICE guidelines also endorsed CBT/GET without adequate data on adverse effects; it acknowledges a "potential to cause harm as well as provide benefit", but also claimed that "the overall research evidence is that the benefits outweigh any harmful effects". The safety data from PACE is not as straight forward as it appears, the threshold for harm was much higher than the threshold for improvement.
At best, it may be said that serious prolonged deteriorations are rare in Oxford criteria patients when attempting carefully monitored CBT or GET. However, no convincing evidence has been published to show increases in total activity levels (with evidence to suggest it does not), so, claiming such increases are safe would be potentially dangerous.
Someone mentioned earlier that Harriet Hall is an advisor to Quackwatch? The website defines quackery as the over-promotion of health irrespective of intentions. PACE and Cochrane refute claims that CBT/GET significantly helps the majority of patients, therefore, plenty of CBT/GET proponents may be guilty of (potentially dangerous) "quackery".
I am just getting in on this discussion...have taken a break from all of this exhaustive thinking and reading... But I am a patient of Dr. Kogelik and the treatments are indeed expensive even tho I am covered under a patient assistance program. I only live 4 hours away and they are running me $1,100 per infusion for infusion fees etc. So it is gonna be a nice chunk of change once all is said and done. I go in for my 4th infusion on Tues. I have improved there is NO doubt but no where where i would like to be... i am going to post an update on my progress soon. I have not heard of long term health issues as a result of Rituxan but ... I haven't read everything there is to read either... Please inform. And I will tell you Dr. K is NO quack... he is a really straight forward genuine guy who wants to help and I say that from experience, being to hundreds of docs since I was 18 frikkiin years old. We are the human guinnea pigs ... that is all there is to it ... it is the only way they are ever going to learn anything about this beast of an illness.
Thanks for commenting here Jacque. I hope you continue to feel benefit from the treatments. Do you have a thread I might follow about your experiences? Thanks.
I just posted under the Rituxan forum... called DOO DOO update... enjoy
An expression of professional ethics is hardly an issue of paternalism – there is a very real issue of what amounts to informed consent. I think you are also relying on a number of fallacies.
(1) Drug safety has to be established relative to the impairments of the presenting patient. No one knows what impact ritxumab might have on any one of the potential subsets and misdiagnoses that are likely present across the M.E/CFS patient population – in that context no physician can honestly attest to safety, they are prescribing in the dark.
(2) That extreme disability is present in part of the patient population isn’t a basis for concluding that ‘the patient population is extremely disabled – no physician or researcher has published any considered basis on how risk versus benefit should be judged relative to differential disability in M.E/CFS. Is it really the case that very ill people are likely the most appropriate recipients ? Or are those not the very people who are the least likely to tolerate a drug ? And if that is the case the argument for risk v benefit evaporates because one would be left with a proposition that only the moderately ill could be recipients.
(3) Competence in medical ethics isn’t simply a matter of legal construction. Informed consent presents far more problematic issues of the emotional status of the patient, as well as the availability of meaningful data and the capacity of the patient to assess it. Other posters here are arguing that the level of desperation of patients is something that physicians should be taking into account – yet desperation would stand as a potential impediment to giving freely informed consent. Any ethically driven doctor would be concerned to at last consider these issues as a bar to prescription.
There is a further issue beyond the concerns of lack of data and the ability to give informed consent, and that is the effect that ill managed off label prescription may have on research. The single definitive gain that came from the Mella and Fluge work, was not that Rutiximab offered curative or ameliorative value, but that it offered a way of achieving insight into the biochemistry of M.E/CFS. Off label prescription on demand, may very well confer a dubious image onto rutiximab which will deter otherwise interested researchers from considering involvement with studies using Rutiximab. This is a serious point because we are highly unlikely to be looking at a couple of $million clinical trials in which Rutiximab treatment will be shown as viable across the M.E/CFS patient population (cost and style of administration are in themselves limiting factors), but rather Rutiximab would be part of a much longer process of teasing out sub group differentials and biochemical processes which underly M.E/CFS aetiologies. Association with clinics which have a poor (deserved or not) reputation amongst clinical researchers could well have a permanent inhibiting effect on the acceptance of Rutiximab as a research tool in M.E/CFS.
Where does that leave us ? Any reader of anything written by someone who says they have M.E/CFS is to assume that the writter is confused and talking rubbish ? In this case the SBM blogger has made a connection with the XMRV fiasco, and whatever the accuracy of the patient blog what was written there clearly presented a potential pattern of misjudgement affecting physician and patient relationsips that deserves exploration.
You are confusing two entirely separate processes. The ACS (or any other reputable medical philanthropic organisation) does not tie its fund raising effort to donors recieving treatment, experimental or otherwise. Indeed no valid research can be derived from this sort of practice and no ethics committee would approve studies that depend on that form of funding. It was one the disturbing aspects of the sale of the VIPdx XMRV tests that, via misunderstanding or not, some people purchasing the tests seemed to belive that the data for the tests would contribute to reseach. Certainly WPI was in a very dubious position when it appeared to encourage purchase of the tests because the licensing fees would "help research".
Funding of research and the delivery of services, whether treatments, investigations or tests, must be kept wholly seperate if the integrity of all of thse involved is to be maintained. Any ethically motivated medical or medical research professional is going to be concerned where the appropriate separation of functions is not in place.
As Chemo goes Rituximab is a mild drug. Certainly for post transplant lymphoma, around where I live, its given in a day hospital and thats for people already on immune suppressants. I think the dose is higher than that proposed for ME or RA as well. Compare this to other Chemo and treatments where patients are kept in hospital or even iscolation wards.
I posted a link to a paper looking at long term safety issues with RA in this thread
The paper you cited is about RA. I don't know if we can compare our condition to RA at least in all respects. The safety profile may be different in me/cfs but the fact remains that we don't know one way or another. That's why real clinical studies are needed.
It would be a shame if this clinic, which seems to have the potential for some valid research, might lose it's credibility because of Dr.Koglenik's treatment.
ETA I wonder how closely patients who are getting Rituimab are monitored. I would think this would be difficult for anyone traveling. This is an important consideration as any chemotherapy drug not only has the potential for short term adverse effects but also long term. I didn't realize until recently that people can die from heart failure, kidney failure, etc. from the damage that chemotherapy can cause, so continued monitoring of the patient's health is important when assessing the risks vs. benefits for a patient getting chemotherapy.
The concerns that the blog poster has raised, and that IVI has expanded on, are indeed valid, well-established ethical concerns within medicine and research and they're legitimately described. Those concerns and ethical principles are also, in my opinion, rendered null and void by the vastly greater ethical issue of the conscious and utterly disgraceful continuing neglect of the patient population concerned, as evidenced by the failure of anyone to fund a follow-up trial to Fluge and Mella's work. That is the context within which this treatment is taking place: it is neither reasonable nor ethical to talk about this subject without recognising that the neglect and the failure to carry out the necessary research is the real problem here, and that is the true cause of the far lesser problem of physicians who are doing their best to do what little they can to help the patients.
Is it reasonable to complain that nobody should be prescribing or taking this drug - even though it's quite legal to do so and the only evidence that exists suggests that it is hugely beneficial to a majority of patients - on the basis that there need to be follow-up studies first, when the only reason this is happening is because the follow-up studies simply aren't happening? What are patients supposed to do when science is just not happening, when the studies are not being done? Is it fair to say "you can't take this drug, because the one study that says it works is not good enough evidence, and by the way, we're not going to do the studies that might provide that evidence"? Patients rightly ignore that Catch-22 and take the best option that's available to them. If there is an ethical problem here, it is not that somebody is offering patients crumbs: the ethical problem lies with those who are failing to offer the patients any alternative and putting them in this situation in the first place.
How long is it now since Fluge and Mella's results were published? 18 months? And yet still there is no funded follow-up study in the US, UK, or anywhere else, despite their findings strongly suggesting that Rituximab may be a safe and effective treatment for a disease affecting many millions of people for whom there is currently no available treatment. That is a scandal that completely dwarfs the issue of off-label Rituximab treatment. What greater evidence could there be that the medical/scientific world is utterly failing to deliver for ME/CFS patients, and has no interest in us at all except to complain vigorously against anybody who tries to help us?
It might seem entirely reasonable to those who have a narrower, dogma-driven agenda, to focus on the ethical concerns of providing a treatment to patients when the treatment is in the early stages of research. In any normal context, where one could assume a reasonable scientific effort to provide the necessary evidence, and a reasonable effort to help patients, then that would be a perfectly reasonable concern. But in proper perspective, focusing on those concerns as an 'ethical' issue while ignoring the far larger ethical issue of the failure of medical, scientific and governmental authorities to ensure that the necessary research is carried out, is just rank hypocrisy and it is not 'ethical' at all. If there were any ethical basis to complaining about this sort of thing, then it would be out of concern for the patients involved. And if there were any concern for the patients involved, then the people complaining would also be highlighting the gross under-funding of medical research for ME/CFS and the failure to conduct the necessary follow-up studies on Rituximab. Talk about ignoring the elephant in the room! Any balanced assessment of this situation would clearly recognise that the reason why practices like this are happening is simply a reaction to the fact that this research is not being done. Anybody who cared would be outraged by that, and would be writing and campaigning vigorously on that major issue of neglect, demanding that the necessary follow-up studies should take place, and demanding that research into ME/CFS should be properly funded. Anyone missing that vastly bigger ethical issue just can't see the wood for the trees.
What's good for the goose is, well, you know You say we can't use other patient groups as a basis of comparison, but then do just that in your ETA. Of course the safety profile may be different, but that's true for every treatment and every individual person. Actually it's true for every part of our life (crossing the street, eating a piece of bread, drinking tap water) - we are constantly using the best data we have to evaluate all of these risks and make the best possible decision for us individually. We never have a guarantee, and we never will, life just isn't like that. We all make decisions about what is an acceptable risk for ourselves.
The woman mentioned in the original article did just that, she made a decision about undergoing treatment. There does not seem to be any evidence that she was misled, only LOTS of speculation by the author and a general indictment that he's treating patients who want to be treated (gasp!). Yes it's expensive but again, that's part of the risk that presumably (no evidence to the contrary) she was aware of. All of the 'controversy' seems to be because the patient doesn't understand, or perhaps just doesn't use, the term 'pilot' in the same way as the author expects. It's an incredibly weak foundation upon which to build this house of conspiratorial cards.
We are adults, desperate or not, and that comes with the privilege and responsibility of evaluating risks, making decisions, and acting on those decisions. I agree that the condemnation of this freedom of personal choice smacks of paternalism (and I'd add a fair amount of arrogance).
I don't think there is anything wrong with bringing up the issue of neglect and yes I am outraged but I fail to see how that exonerates a physician to ethically prescribe a drug we simply do not have enough information about to say, one it is safe, nor two it will help. Yes, it's terrible that there aren't any studies funded but unfortunately, that is the reality and can't be used as an excuse to say this doctor is doing what is ethical.
I find it a bit insulting that some here think that just because someone questions the use of Rituximab, it means we are ignoring any issues about patient neglect as well as how desperate we are for a cure.
Unfortunately, what Dr. Kogelik is doing will muddy the waters of future studies.
I think we can see both the forest and the trees to come up with this conclusion as well as the other.
A drug may cause side effects across the board with individual responses within this context. However, the question remains is if it will help with me/cfs. The two really don't have anything to do with each other.
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