Discussion in 'General ME/CFS News' started by Sasha, Jul 30, 2013.
Yes, I think they may be more to do with who to give CBT than looking for causes of diseases!
Do you know whether the Fluge and Mella choice will be narrowed down a bit further in their upcoming study?
Theres enough stuff on the internet done by klimas and peterson with petersons latest being the ihhv6.
I suppose we wait for the 2 pathogen studies to be done, the one by Stanford with dr montoya and the other pathogen study by lipkin.
I still think there going to have to put people into the right subsets first. Im not anti ritux, i think its going to do good things for the right sub set. I think we are slowly working out sub groups by which patients respond to certain treatments. Theres definately a antiviral/herpes subset and it looks like they haved found an auto immune subset. Are these people that respond to ritux have any other biomarkers, maybe higher inflammatory markers or ANA.
I think there is alot of interesting things about to unfold, its just not happening quick enough.
I took a look at the Invest in ME Website and they have a Description of their trial That Dr. Edwards is advising. Here is it's web address:
here are 3 Interesting points:
- Invest in ME have arranged for Professor Edwards to visit Dr Fluge and Professor Mella in Bergen, Norway to discuss the clinical trial in detail - thus enhancing cooperation and research.
• Invest in ME have agreed to fully fund the preliminary study by UCL which is a pre-requisite to the full clinical trial. This will begin shortly.
• The preliminary study will be a small study which will confirm the earlier work of Dr Amolak Bansal  on B-cells but using a different cohort of ME patients.
If you look at the reference cited in the work of Dr Amolak Bansal , You will see that Dr Amolak Bansal Used patients that the criteria for the Canadian and Fukuda Definition.
@ Jonathan Edwards, Have you gotten a chance to get that trip over to Norway yet? Nice chance to chance to collaborate and learn from others.... for both you and the Norway Contingent.
Professor Edwards thank you for discussing infections. This may be a bit off that topic but maybe not, I've heard many ME/CFS patients describe not catching common colds or flu since becoming ill with ME/CFS noting that before ME/CFS they would experience several in the course of a year. Might this point to an overactive upregulated immune system and perhaps that loop you refer to earlier in the thread?
Perhaps we should have a poll on another thread for that Gemini regarding colds. I have had severe ME and I still get the usual amount of colds. But interesting that some ME'ers don't get colds.
Re: criteria and my own previous call for NICE to be used as a minimum in terms of both criteria and methodological assessment.
In order for Rituximab to become licensed for use in CFS/ME both NICE would need to endorse and (I understand) the MRHA - Medicines and Healthcare Regulatory Products Agency would need to approve.
Now, albeit it was waaayyy back in 2007, when NICE published their Guideline (though it remains in force and has not been changed) they did review, incorporate aspects of, and reject other criteria as were then available for review: though it wasn't so much NICE in isolation if I recall but NCCPC and RCGP.
You can read all about it still in the Full Guideline from I think (interactive index btw) pp. 124 that is section 5.1. including the review of the then other and existing criteria (such as the Canadian - rejected I recall because of it's deemed poor methodology) and each of the reviewed criteria pro's and con's - at least in the opine of these expert advisers.
Now, I will concede at this juncture that I am rather confused by the difference between 'clinical' and 'research' in terms of criteria for a condition defined by symptoms and exclusion; and it may be that if NICE were considering a 'research definition' they would have more more favourable of the Canadian: but I can't honestly think it would have made a difference.
Jonathan Edwards I guess you don't want to get drawn in to this debate much - but what is the difference really between 'research' and 'clinical' definitions/criteria in your opinion? Thanks
I was but also the methodology used to determine a diagnosis including tests and exclusions etc.
Bit of a wonky memory there Bob me old mate
Funny really as we have spent so long discussing NICE over the years, but only to be expected of course.
You're up early!
You buggar! A LOL caused yet another caffeine spillage
Yeah I know. Got fed up with the 'issues' at 3am and thought 'sod it'. You know how it goes my friend. Still, I'll probably slide back into the sack a little bit later.
Have yourself a NICE day on the other side of la Manche
This interests me as well. Following the intense flu which seemed to trigger the sudden onset of ME, I didn't get a cold or flu for a decade. This sort of observation is sometimes written off as an effect of ME induced "isolation" from infection opportunities, but I had a lot of contact during that decade and was not housebound for most of it. I only came down with the flu again after my symptoms had improved somewhat.
I was frankly surprised when I saw the same thing being reported by others. I think there was a poll on it here a while ago. While some people seem to become more susceptible to infection, others seem to become more resistant.
No, that has not been decided.
I don't think it really works to talk of an overactive or underactive immune system. Autoimmune loops do not necessarily have any effect on responses to infections. Remember that most of our symptoms of infections are due to the immune systems's response.
I think ME/CFS physicians are in favour of the CCC for something more tightly defined. However, we have to follow the evidence so far. We do not know that CCC would better define rituximab response. It is possible that post exertional malaise is a specific feature of the sort of ME that is not B cell related - then we would really mess up if we insisted on it in a trial. We can only work methodically from one step to the next. Also the CCC is worded in a way that does not lend itself well to drawing logical conclusions from findings on such a group - because there is a lot of 'some of this or some of that' in it. Complex sets of diagnostic criteria like this are rather archaic from a scientific point of view - like the Duckett Jones criteria for rheumatic fever. Once we have a foothold on mechanism I would throw them all in the bin, but for the moment the priority is to make sure that studies can be compared where it is useful to do so.
I think it is not as much not getting a cold but the normal symptoms do not show because the immunesystem reacts different.
For many many years I wished to get a good flu to get the immunsystem go back on track but that did not happen.
Something is changing for the better now. Nose mucous membrane becomes more moist and rapid turnover occurs. Lungs are working better and none productive dry cough has changed to productive cough.
I have long experience of these bodies! NICE is just a place where various different chaps at different times get together to try and decide what is most sensible clinical practice. They change their minds all the time. It is a bit like the Court of Appeal - any time another lot of judges can come along and say something different. And there is no particular reason why NICE guidelines for using rituximab in chronic fatigue should have to mention NICE diagnostic criteria for CFS. Guidelines for drug usage call on all sorts of criteria other than diagnostic ones. NICE diagnostic criteria might indeed be good but I don't think one would choose them for licensing reasons.
The reality is that there are an infinite number of sensible ways of dividing clinical problems up, depending on the situation and criteria have never seemed to me to be very helpful in most of them. As an example one might want clinical criteria for 'quite likely lupus' which meant that it was sensible to check blood pressure and a blood count for the patient every three months. This would not be the same as criteria for entry into a lupus trial of rituximab which would exclude patients who had no current problems or just had damage from old disease. It may be that the distinction between clinical and research criteria is the wrong way to look at it. It perhaps should be a distinction between criteria for practical decisions and criteria for testing scientific theories. To be honest the whole thing is a mess and as complicated as there are numbers of questions you might want to ask. We could do a rituximab trial just in people with post exercise malaise, maybe excluding people who have known active infection like TB or flu. That might test some interesting theories about PEM, but not about other aspects of ME.
Standardised criteria are junk really - each question has its sensible choice of patients.
All but two of the subjects in the 2011 study did meet the CCC, however:
In this interview, an early intention is reported to again use the “so-called Canadian criteria:"
In the early days of ME my symptoms became much milder when I caught a cold or flu (or seemed to catch a cold or flu). But then I seemed to stop getting colds and flu altogether, despite interacting with others, including those who were probably infectious. If a friend says that she is worried about coming over in case she gives me the cold or flu she or her children have, I laugh and tell her not to worry as nothing seems to get past my immune system!
Your changes do sound positive, by the way, lansbergen.
I swear that much more of this spitting of my coffee due to unexpected laughter, and I shall be requiring a new computer monitor! Faceless bureaucracy 'tis everywhere but some hurdles you gotta leap - unfortunately...
I've read about these immune system things before and they always seem strange - perhaps it is the immune system just acting differently when presented with a challenge, I for one know the last time I got a cold - a few months back - it made me feel so incredibly ill, i'm never usually bed-bound but I spent the entire week on the sofa feeling congested, nauseous and dizzy. Perhaps it was just the cold on top of the standard ME symptoms that made me feel so bad.
I believe Fluge and Mella had noted this difference that patients describe and seemed to think from early trials that it didn't seem to effect patient outcome with rituximab. I'll see if I can find the interview where I read that.
Interestingly, a doctor suggested to me recently (I am the same with colds and flu) that it might be that we do get the colds etc, but don't exhibit the same immune responses, eg the sniffles etc are immune responses. I don't have the background to evaluate his comment, but if it is the case, it would add a new perspective to our immunity issues.
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