Counter petition to the MEGA petition, brainstorming stage

[Sidereal]

This study is beginning to sound like a nightmare. Essentially they will be studying unexplained chronic fatigue of sufficiently mild severity to permit attendance at those ridiculous fatigue clinics. It is likely that some of these people will have ME/CFS but the sampling bias created by using fatigue clinics will be a very big problem because the clinics usually discharge ME patients once they have been harmed by or refused GET or the patients themselves stop going once they realise the crapola that's on offer. We have a PACE-like sample of mostly newbies with unclear diagnosis to look forward to.

 

[Valentijn]

It sounds as if the criteria to be used are unclear because Crawley is completely in control of criteria and recruitment, and isn't clarifying the situation. So of course, none of the other people involved can clarify the situation, though they seem rather unconcerned about it.

It would be a pity if we had to start boycotting potentially good research to stop it from being polluted by psychosomatic theorists and piss-poor diagnostic criteria. But with the UK charities and other agencies dismissing or ignoring patients' fundamental concerns (except to compare the objections with the killing of newborns) maybe it's the only choice left.

I'm not in the UK, so my influence is very limited. But if we allow them to keep getting away with this, it's going to keep happening. If we unequivocally put an end to it now, maybe the next biomedical project will actually use biomedical ME/CFS criteria and researchers.

 

[Sidereal]

Odd comparison, @Simon. The Lipkin/Hornig sample was biased, yes, but it was very much biased in favour of including ME/CFS patients since the doctors they sought out know how to diagnose it (as accurately as current biomarker-free circumstances permit). So you're left with biases around socioeconomic status and being able to travel long distances to those clinics. It's a problem but it's nowhere near as problematic as the unexplained-fatigue-even-broader-than-Oxford nightmare unfolding here in Mega. I'm not at all opposed to a large study of fatigue. Perhaps it will end up yielding useful insights. What I don't like is this being sold by charities to ME patients as 'biomedical' research into their illness, when it isn't.

 

[charles shepherd]

And the evidence for that is? I'm sure some do, but does this mean we have clinics of PEM-free patients? I'd love to see some evidence of that. My guess is that the vast majority of UK patients aren't as well-informed as those on PR and won't all be boycotting the clinics because they don't trust them.

I'm pretty sure that Lenny Jason ran a study with patients from Newcastle and found most Fukuda patients there also met Canadian criteria. The NICE criteria require post exertional malaise or post-exertional fatigue (I know the two are differen,t but that's the definition in the Canadian criteria too). So more evidence would help, but I don't thin sweepiing statements get us very far.

No study is perfect. Take the Lipkin/Hornig cytokine study, the largest biomed study in the world to date so far, which I wrote about here
New era for ME/CFS research as top cytokine study attracts media headlines (Hornig/Lipkin)
It's the most-lauded published study in our history. But the sample is not ideal. The samples for that came from the top US clinics. Again these clinics have a bias to highly-educated patients, not least because they all have to have health insurance (or since insurances don't always cover mecfs, tragically, the means to pay privately). There are only half-a-dozen of these clinics in the US, biasing the sample to people well enough to travel long distance, much further than UK patients would travel. These are inevitably biased samples, though they are drawn from different parts of the US.

I agree that patient selection is very important. But I'm concerned about knee-jerk damning of an approach in one study when no such scrutiny is shown for other large studies. A perfect sample won't be possible, but we do need a good one.


I think that's an issue worth raising. Obviously the severely-affected are much harder to reach and diagnose (way more expensive per patient). I don't know if using the biobank for severely-afffected is an option. But I do think it's a question that should be put to MEGA.

Simon - that is a very valid point about the inclusion of people with severe ME/CFS and the ME Biobank now has a good collection of samples from people with severe ME/CFS who meet with both Fukuda and Canadian diagnostic criteria. The MEGA trial protocol is still being developed, along with the way in which patients will be recruited, and the role of the ME Biobank at RFH has still to be discussed.

 

[AndyPR]

For what it's worth, I have just sent the following email to Stephen Holgate (Chair of the CMRC);

Professor Holgate,

I'm sure you are busy so I'll attempt to keep this brief and to the point.

The recently announced MEGA project has been met with, what seems, a number of serious concerns by a large section of the patient population, which is hindering the public support for the project. I would imagine that some, if not all, of these concerns are due to misunderstanding and lack of information so I was hoping that you could advise me of the best route that patients could take to have these concerns addressed.

Many thanks in anticipation.

I'll update when/if I get a response.

 

[charles shepherd]

For what it's worth, I have just sent the following email to Stephen Holgate (Chair of the CMRC);

I'll update when/if I get a response.

That is a very sensible and constructive move at this point

Your letter, as you say, is short and to the point

 

[eafw]

@charles shepherd

- I've given this some thought over the last few hours, I didn't want to react in a knee-jerk way. But having considered it carefully, I object to this title the MEA has chosen. I think it's a very poor choice and the MEA should change it.

I want to bump and underline this post from snowathlete, headlining a piece like this is a very poor choice - it plays right into to the myths about violent ME patients, and it is not at all fair reflection at all of what people are saying. It will cost nothing to amend the title: "Give MEGA a chance" or some such thing would really ease the situation here.

 

[trishrhymes]

For what it's worth, I have just sent the following email to Stephen Holgate (Chair of the CMRC);

I'll update when/if I get a response.

Andy, can you post this on the other threads about MEGA including the open letter thread so we don't have duplication of effort. I for one am finding it all a bit confusing having bits of the discussion happening in different places and am not sure where to say what and what has already been said! Not anyone's fault, just a bit of a strain on a foggy brain.

 

[eafw]

I for one am finding it all a bit confusing having bits of the discussion happening in different places and am not sure where to say what and what has already been said!

Me for two. I had to go digging through my own post history this morning to try and remember what I'd posted where before re-reading the threads again.

 

[Wildcat]

.

@Simon .....


re your response to my post ..... your post 199, in response to mine 179.


Raising concerns about entrance criteria for this MEGA study, and raising concerns about recruitment is not unreasonable. Dismissing such concerns as "knee jerk" is not helpful, indeed rather insulting to the intelligence of those raising the concerns..

.

I would add that I was the first person on this thread (I believe) to point out that recruiting from the clinics would exclude severely sick housebound and bed bound people who are a significant percentage of the UK ME population (a point that those representing MEGA have not so far considered) …


…. so portraying my concerns on this thread as ‘knee jerk’ would not appear to be accurate. The concern about the apparent exclusion of severely sick patients is now been taken to the MEGA team by Dr Shepherd, as a result of concerns expressed on this thread. But really, inclusion of severely sick ME patients to ensure the study is actually representative, should have been a consideration at the design stage of the study.


Other researchers have stated that studying severely affected patients may be the key to understanding ME. .

.

Recruiting from the clinics would also exclude the significant numbers who do not attend the clinics because (as I have already pointed out on this thread) they have been ill a long time, have learned to pace themselves, or seek private treatment as the clinics do not offer any actual treatment, and the clinics can offer them nothing.

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There is a big world of ME communications out there beyond PR (a certain level of cognitive operating is required simply to register and find ones way around the PR forum) ..... but it was clear from the forums which existed well before PR that a very significant numbers of patients nationwide were deeply frustrated/concerned with the set up of the clinics which followed the 2002 CMO’s Report; ... those patients had no intention of engaging with the clinics, which do not specialise in ME. Did you know that the clinics were first funded at the same time the PACE and FINE Funding were given, a kind of ‘starter’ amount of money for the clinics, included in a block sum, for clinics and research (PACE and FINE). The setting up of the clinics was linked to the recruitment for PACE.

.


The second point is that having been referred to a clinic, and found that no actual help was involved, people who had asked for referral saw no point in continuing, so those people no longer attend the clinics.


We have been reading on social media (year after year) endless heartbreaking accounts by recently ill patients who had been referred to a CFS clinic by their GP, expected actual help, were given a poorly explained pacing guide, with establishing a ‘baseline’, timing their activity and rest, which most found unhelpful/unworkable, and little more. Some said they were devasted after attending the clinic and asked “Is that it??”.



The petition in favour of MEGA comes across as cheerleading, enticing patients to appear to be endorsing the study before they actually know much about it. That comes across as rather manipulative.



Finally, there is no patient consensus that MRC research funding should spent on ‘broad church’ or ‘big umbrella’ studies. The idea of ‘Big Umbrella’ research has been imposed on us from above. Clearly AFME/Sonia Chowdhury and Esther Crawley and Peter White are in favour of such wide based fatigue studies …. But they always were. Its blatantly clear that Peter White's and Esther Crawley's definitions of CFS are really chronic fatigue/fatigue conditions, and are a long way from CCC/ICC definitions of ME. And AFME as a charity caters to the 'broad church' of 'fatigue conditions'


ME patients are still waiting for MRC funded studies on a well defined ME population/CCC/ICC (including severely sick patients), with no psychosocial spin bolted on.
.
.

 

[slysaint]

Me for two. I had to go digging through my own post history this morning to try and remember what I'd posted where before re-reading the threads again.

maybe merge them all into one big MEGA thread?

 

[snowathlete]

So there has been quite a lot of objection to the title @charles shepherd, not just from me, but it still hasn't been changed. I assume you've seen the posts because you've posted since. I'm really disappointed by this.

 

[Simon]

Odd comparison, @Simon. The Lipkin/Hornig sample was biased, yes, but it was very much biased in favour of including ME/CFS patients since the doctors they sought out know how to diagnose it (as accurately as current biomarker-free circumstances permit). So you're left with biases around socioeconomic status and being able to travel long distances to those clinics. I.

Firstly, travel is likely to be strongly linked to severity, and many people have already flagged that up as an issue. Secondly, in any disease, it' a concern is you have some indicators of strong bias because it's possible a whole load of other things are biased too (unknown, but may well be important) - hence the value of population studies. IF you wanted to study an illness you wouln't ideally choose just 6 specialist clinics in a vast country. That doesn't negate the findings by any means, but it does suggeset it's not an ideal sample. I think we should be consistent in evaluating studies.

It's a problem but it's nowhere near as problematic as the unexplained-fatigue-even-broader-than-Oxford nightmare unfolding here in Mega. I'm not at all opposed to a large study of fatigue. Perhaps it will end up yielding useful insights. What I don't like is this being sold by charities to ME patients as 'biomedical' research into their illness, when it isn't

Where does broader than Oxford come from? Where is the evidence that this will simply study chronic fatigue and there will be no mecfs patients. I'm up for debating the science, but I'd like to do it on the evidence.

 

[Valentijn]

Where does broader than Oxford come from? Where is the evidence that this will simply study chronic fatigue and there will be no mecfs patients. I'm up for debating the science, but I'd like to do it on the evidence.

There is no evidence - it's being withheld. The only evidence we have currently is that "broad" criteria will be used and Crawley seems to be in charge of both the criteria and the selection of patients.

It doesn't bode well.

 

[Sidereal]

Firstly, travel is likely to be strongly linked to severity, and many people have already flagged that up as an issue. Secondly, in any disease, it' a concern is you have some indicators of strong bias because it's possible a whole load of other things are biased too (unknown, but may well be important) - hence the value of population studies. IF you wanted to study an illness you wouln't ideally choose just 6 specialist clinics in a vast country. That doesn't negate the findings by any means, but it does suggeset it's not an ideal sample. I think we should be consistent in evaluating studies.


Where does broader than Oxford come from? Where is the evidence that this will simply study chronic fatigue and there will be no mecfs patients. I'm up for debating the science, but I'd like to do it on the evidence.

Firstly, as I said in my post, the Lipkin study did have the same limitation re: severely affected as practically all research into ME/CFS. Just because that study didn't include the bedbound/housebound people it doesn't mean MEGA should exclude them too.

Regarding inclusion criteria, Dr Shepherd was talking about a broad CFS cohort from fatigue clinics and even unexplained chronic fatigue cohort in one of his messages:

http://forums.phoenixrising.me/inde...-brainstorming-stage.47107/page-8#post-770859

Facts are thin on the ground so speculation abounds. It would be nice if the MEGA team communicated study design to the patients before asking them to sign a petition supporting a study we know next to zero about.

 

[AndyPR]

So, I have good news and bad news

Thank you for your email. There clearly is a misunderstanding which is always a risk when trying to explain complex reasoning behind experimental design in this hypothesis-free approach to uncovering novel causative pathways in complex diseases. I am consulting my colleagues at the CMRC to try to offer the best answer without getting too tied up with detail.

We will get back to you.

Kindest Regards,

Stephen.

His reply was cc'd to Sonya Chowdhury (to be expected I suppose) and to Esther Crawley.....

I'll leave it to you guys to analyse it, I don't have time at the minute.

 

[Valentijn]

So ... "I can't tell you the details, because you're too dumb to understand them"? He's also loading up with supposedly impressive terminology to try to put you in your place.

Can we get rid of this guy too?

More seriously, can the CMRC be replaced, or a biomedical alternative put in place?

 

[TiredSam]

I am consulting my colleagues at the CMRC to try to offer the best answer without getting too tied up with detail.

We've had that. It's the answer that gets tied up in the detail that we want.

 

[AndyPR]

So ... "I can't tell you the details, because you're too dumb to understand them"? He's also loading up with supposedly impressive terminology to try to put you in your place.

Pretty much my thoughts but it's my first email from him, perhaps I can impress him with big words at a future date.....

 

[BurnA]

More seriously, can the CMRC be replaced, or a biomedical alternative put in place?

I think this is our only hope, it won't happen as long as charities support it though.

It should be disbanded at this stage, or else a complete change of personell and a rebranding to the "Bio CMRC".

All the old guard with links and ties to you know who have to go before this can ever have any credibility.