Why is Koglenik treating patients with Rituximab at this point when others are saying 'Wait' for clinical trials?
Because it's legal and because patients are making the informed choice to do it.
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Why is Koglenik treating patients with Rituximab at this point when others are saying 'Wait' for clinical trials?
A recent thread got into the relevant subject of patronization but was locked soon after. I will exercise discretion here.
OBJECTIVES: Evaluation of long-term safety of rituximab in rheumatoid arthritis (RA).
METHODS: Pooled observed case analysis of data from patients with moderate-to-severe, active RA treated with rituximab in a global clinical trial programme.
RESULTS: As of September 2010, 3194 patients had received up to 17 rituximab courses over 9.5 years (11 962 patient-years). Of these, 627 had >5 years' follow-up (4418 patient-years). A pooled placebo population (n=818) (placebo+methotrexate (MTX)) was also analysed. Serious adverse event and infection rates generally remained stable over time and multiple courses. The overall serious infection event (SIE) rate was 3.94/100 patient-years (3.26/100 patient-years in patients observed for >5 years) and was comparable with placebo+MTX (3.79/100 patient-years). Serious opportunistic infections were rare. Overall, 22.4% (n=717) of rituximab-treated patients developed low immunoglobulin (Ig)M and 3.5% (n=112) low IgG levels for ≥4 months after ≥1 course. SIE rates were similar before and during/after development of low Ig levels; however, in patients with low IgG, rates were higher than in patients who never developed low IgG. Rates of myocardial infarction and stroke were consistent with rates in the general RA population. No increased risk of malignancy over time was observed.
CONCLUSIONS: This analysis demonstrates that rituximab remains generally well tolerated over time and multiple courses, with a safety profile consistent with published data and clinical trial experience. Overall, the findings indicate that there was no evidence of an increased safety risk or increased reporting rates of any types of adverse events with prolonged exposure to rituximab during the 9.5 years of observation.
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.
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.
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??
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.
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.
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.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
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.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.
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.as others said, they don't get this illness or they would cut her some slack re; the neuro cog issues.
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".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.
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.Chemotherapy drugs can be very dangerous. It's a situation where you have to weigh the positives against the negatives.
Barb C.
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.
Barb C.
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.
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).