MEGA Questions and Answers: Latest Petition update

[BurnA]

It will be important to collect data on people with ME/CFS who also have some form of mental health/psychiatric co-morbidity (e.g. depression or anxiety) to see if there are any biomarkers, or a group of biomarkers, that differentiate people with ME/CFS with no psychiatric co-morbdity from those who do

I assume you do accept that people with ME/CFS do sometimes develop clinical depression - because it does happen

Yes it does happen. But I wonder if biomedical studies into cancer, MS or other awful illness also include this aspect. I don't quite see how it helps our understanding of the illness ME / CFS. If people want to study comorbid conditions I have no objections but I would prefer if they applied for money separately as it would avoid confusion as to what is actually being researched.

 

[actup]

White and and Crawley must go for me personally to take this project seriously. These two can never ever be trusted. It feels like a great injustice to allow them a soft landing after the great damage they've done to many, many millions of me/cfs patients around the world.

It's a bit like Brinks hiring a couple of ex con serial armed robbers as armored car drivers. Even if White and Crawley were to have a very limited role as consultants/ advisors ,which I strongly doubt would be the case, it again gives them a soft landing w no consequences for their past crimes against humanity. Those many who've died early deaths after miserable existences deserve some justice.

Hope I'm no too wishy washy re: my opinions.

 

[Glycon]

Hope I'm no too wishy washy re: my opinions.

I would say that you are, but that it's understandable under the circumstances.

 

[Jan]

I have just posted another response to the petition, I think they will probably remove it as it's rather controversial. It had to be said.

 

[Jan]

Basically, most of us have no trust in the fatigue clinics full stop and none of us want the NICE guidelines to be used as they do not describe the illness we are suffering from.

I do not trust the clinics not to 'cherry pick' and send you the least affected patients. It is not in the BPS psychiatrists interests for the biological data to be exposed, they have managed to conveniently ignore 5000 research articles into biological aspects of the disease thus far, whilst taking the lion's share of any available research money. We've been left with no specialists to help us for decades due to the illness being hijacked by these BPS exponents. Nobody to turn to when you get new and often frightening symptoms, no support for benefit claims, no support full stop. We don't fit with their beliefs, so if we do not recover after get, or we relapse whilst attempting it, we are sent on our way and never contacted again. Many people have relapsed very badly during these treatments, becoming permanently housebound or bedbound because of it, yet no follow up or even concern from the clinics.

Letters written by Sir Simon Wessley have been released by FOI request, Wessley actively tried to deny ME sufferers any disability benefit. He has no proof that this illness is psychosomatic, yet urged DLA not to listen to Charles Shepherd of the MEA who advised them the illness should be classed as neurological.

Please try to understand the desperate situation we are in, we desperately need this biological research and want nothing more than to partake in it, but how can we when the people behind the now hugely discredited PACE trial are involved?

Please help us, we've been left without support for decades, with no-one to turn to but each other.

 

[taniaaust1]

Except the problem is not the involvement of psychiatrists, but the involvement of specific psychiatrists associated with discredited, probably dangerous, and possibly fraudulent research into ME/CFS.

and its acceptance of things such as these frauds who get paid by insurance companies etc being involved in studies which will end up slamming our communities once again in the face. Ive warned about so many things over the years including the PACE trial which I was against in first place as even back then it was obvious how it would go. It saddens me that there will always be some in our communities who do not see what is going to happen and keep thinking things are going to be okay.

No research is better then misleading poor research!

And as a community we shouldnt be accepting worldwide anything study or believing its going to be helpful to a world level unless its at minimum the CCC definition (if they take only those it will not matter from where they are recruited and there wouldnt be the other dispute going on over this study).

We seriously got to put our foot down and get rid of these ones willing to do corrupt studies from our studies. They should be barred if not in jail for what they did with the PACE trial, they purposely mislead and have done a lot of harm. They should be being prosecuted.

That definition they are using for this study, on looking it it someone with ONLY POTS without ME could met it as a person who gets postexertional fatigue immediately while doing something can still fit it as its only like suggested the "24hr delay" so isnt necessarily. Nothing there to say they have to have it. That with one other symptom, WILL allow those who dont even have ME into this study.

So this could cause this study to be a failure or be very poor by non ME/CFS people in it. Have a look for yourselves,one with ONLY POTS and no CFS could make this study based on that CFS defination they are using.

This study should only be going ahead if the fraud ones are removed (and why need a psych expert when you dont have a neuro expert or an immune one involved?) and if all the ones are recruited with at least all having the CCC. but I dont think that is going to happen.. why? cause it appears someone with psych biases is still holding the strings. Are you going to be fooled?

 

[taniaaust1]

Basically, most of us have no trust in the fatigue clinics full stop and none of us want the NICE guidelines to be used as they do not describe the illness we are suffering from.

I do not trust the clinics not to 'cherry pick' and send you the least affected patients.

and most severe ME people do not use them or even ones less severe with obvious ME. Its why it the canadian consensus definition should be being used if they are recruiting from there to least try to balance things a bit.

the psych CBT/GET crowd do not have the biological people overseeing all their studies, in fact they seem to ignore those aspects so why have anything to do with this, why are they being involved in this study.

You do not need a psych to diagnose ME/CFS and besides if recruiting from the NICE clinics wont those already be diagnosed.. so why are they there. I can only think of one reason,.. that being to try to lead this study down the garden path again and away from as much as they possibly can by any means they can, lead away from what the true findings would be.

that group do not want indesputable problems to be found, they want to keep ME/CFS under the psych banner. As I think another put, its like giving one who previously did an armed holdup the keys to the bank and him the job as the security advisor. This study poorly done could set us back even more.

 

[Glycon]

People really need to stop equating psychiatry with the psychological approach to ME or the advocacy of CBT as a cure for it.

Such kneejerk myopia just makes some of you look like the caricatures drawn by the very people you oppose.

A doctor who dismisses out of hand the possibility of any and all psychogenetic explanations of the symptoms of ME/CFS is just as misguided and irresponsible as the doctor who assumes that these are the only possible explanations.

(First thing I insisted on when my symptoms began is a psychiatric evaluation. Not only did it help save everyone time, but it also helps keep other specialists on the right track.)

 

[Boronia]

"Patients with CFS/ME will be identified by clinicians in the NHS clinics."
This is hugely concerning.
I am not in the UK and have no personal experience of NHS CFS Clinics but have followed a wide variety of Facebook ME/Cfs groups for many years now.
The general gist of comments about these Clinics is that they offer very little, often have staff who are not very familiar with ME/Cfs, are useless if you do not want GET/CBT, push GET/CBT, discharge you from their service if you do not want GET/CBT and do not carry out any follow up on patients.
Therefore it seems that most patients with ME/Cfs are not involved with NHS CFS Clinics, especially, as others have stated, severe and longer term patients.
I do not have a solution to recruitment but do not agree that this is the best way. Other ways of recruitment need to be looked at.

 

[Cinders66]

As MEGA are now talking about a biorepository,, which sounds a lot like a biobank to me, I'd hope the would consult with the UK mecfs biobank on how to go about this. But the mecfs biobank, like MEGA, draws from NHS clinics (I didnt spot anyone complaining about that, but maybe I missed it) and MEGA will define patients according to multiple criteria. All biobank samples meet Fukuda and most meet Canadian; for MEGA all will meet NICE (I'm not sure which is 'better' between Fukuda and NICE, neither are ideal in my book) and will also diagnose according to other criteria..

So ultimately they will be very similar - as I understand from the Q&A, researchers could pull out a sample of CCC-only patients from both.


Worth mentioning that the uk biobank selected on Fukuda, but most of those still met Canadian. I think Lenny Jason has done a similar study finding the same. So I don't think there's any good evidence that using looser criteria (Fukuda or NICE) will exclude patients with a tighter criteria such as Canadian.


Yes, we need more detail. Eg willl they use Lenny Jason's DePaul symptom questionnaire to diagnose Canadian, as several groups do. The biobank used its own unpublished questionnaire to categorise patients as meeting Canadian criteria (that's not ideal either - but then many of the issues raised about MEGA apply to many other studies).

As for PEM, I think that's a very important question. Jason has done some of the best work on this, but I'm not totally convinced by his questionnaire: his analysis concludes that the single best q for defining PEM is "a dead heavy feeling in the muscles". I wonder how many people here would agree with that.

So I think these are all important issues, and we need to know how MEGA are doing this - but I'm not sure there are lots of perfect solutions out there already.

I think fukuda select a sicker patient group whereas NICE are as someone said 50 shades of fatigue. Fukuda are superior therefore to me although deeply flawed with PEM only optional. I would imAgine NICE will select a broader fatigue cohort but I don't think NICE guidelines as a criteria have been subject to much critical interest.

I still think this is research based on the interest and preoccupation of those who've always insisted the uk cfs umbrella is not posdible to subgroup /and /or have been stubbornly resistant to th e idea of distinct ME and already in existence good criteria to select that, rather than research to rapidly further understanding of ME and severe ME

 

[Valentijn]

It will be important to collect data on people with ME/CFS who also have some form of mental health/psychiatric co-morbidity (e.g. depression or anxiety) to see if there are any biomarkers, or a group of biomarkers, that differentiate people with ME/CFS with no psychiatric co-morbdity from those who do

And it opens the door nice and wide for the established psychobabblers and enthusiastic hacks writing their thesis to take that data and do nasty things with it.

If I were taking part in a biological ME study, I would not be willing to answer inappropriate questionnaires which equate my physical disability and symptoms with a psychiatric disorder. And unfortunately, those are just the sort of questionnaires which the psychobabblers love.

 

[Ysabelle-S]

I won't sign this petition either. I won't sign with Crawley and White there, and if they replace them with other likely proponents of the BPS model, I won't sign it then either. The problems have been pointed out by others. Any money I've given myself to research has gone to other countries. Frankly, the UK might achieve more if it just hands the dosh over to Stanford, Columbia, Naviaux, or any of the other international research teams. Let them get on with it.

I don't doubt there are researchers in the UK who'd love to get to work on this illness (some of them maybe on this forum too), but we're not dealing with them alone here, and that's the trouble. The BPS crowd have managed to hitch a ride yet again, and to god knows what cost for the study. All I saw in the petition's recent update statement is fatigue fatigue fatigue. I didn't even have fatigue in the early years, not that I recall. I do remember being completely bemused by fatigue being played up in an ME leaflet I read in February 1986. And that was in the days before CFS. As I said on Twitter, I had immune, eyesight, and neuro symptoms from the very beginning (acute viral onset). I had PEM. I did not suffer from chronic fatigue, otherwise I wouldn't have been walking an hour to uni and an hour back some days. And I walked a lot. Then I'd get swollen glands, viral & neuro symptoms, plus eyesight problems.

I'm also not impressed with how patients are going to be recruited here. There is a basic problem with the NHS guidelines on ME. I don't trust them to recruit people who actually have ME. I think there's a danger we'll end up with the same mixed cohort issue because they use rubbish diagnostic criteria. The severe patients are the most important group for study. That's where they're most likely to find things. They need to include that group, but those patients are not attending those clinics. Most ME sufferers never attend those clinics. And some of those who do probably don't even have ME.

I don't think the UK is in a position to do a proper investigation of ME until they tighten their diagnostic criteria, throw the psych lobby out, and stop using dubious fatigue clinics for trial recruitment.

 

[A.B.]

The UK isn't ready for large scale biomedical research. The BPS model has failed to produce any results as demonstrated by a critical evaluation of the PACE trial, but it continues to exert influence. Being unable to achieve results after 25 years is a pretty good indicator that the model is wrong and that these so called experts are just babbling. Consulting them risks putting the study on the wrong path.

UK research is going to make faster progress when it finally admitted that the BPS model has been a collossal waste of time and resources, and is a mistake that should not be perpetuated any further.

 

[eafw]

The severe patients are the most important group for study. That's where they're most likely to find things.

Yes, we really need to keep making this point to the scientists - these people are the most interesting, and if you are are not studying them then you are not studying ME.

I won't sign with Crawley and White there,

I think White is mostly gone, but the fact that CMRC are happy to keep Crawley, and without any statement about the failure of PACE and the BPS model is a problem. Besides which, shouldn't she be busy with the MAGENTA study ? Do CMRC want to answer to that at all ?

I don't think the UK is in a position to do a proper investigation of ME until they tighten their diagnostic criteria, throw the psych lobby out, and stop using dubious fatigue clinics for trial recruitment.

The UK researchers will make themselves look very closed and backward in the eyes of the rest of the world if they plough on with NICE criteria, and if CMRC as an organisation carry on with the pretence that if they ignore the PACE debacle it will somehow all just go away. Again, I don't know why these supposedly whizz-kid, big-name, new-to-ME scientists that we are supposed to be so grateful to are being so blinkered about this.

 

[snowathlete]

Psychiatry is very much needed because of the nature of the symptoms. This is especially true given the criteria that are going to be used to recruit patients for this study. Sure ME/CFS isn't a psychiatric illness. But many people will be recruited into the study who do not have ME/CFS.

What is needed is GOOD psychiatry. The kind most people with ME have not had the opportunity to experience.

No one has anything against good psychiatry, but I'm still not clear what that purpose of such a role would be in this study. The focus of the study is supposed to be omics in ME/CFS. The fact some might actually not have ME/CFS doesn't mean they therefore have a psychiatric illness of course, but I accept a number might - but so what? Unless there is a need for a psychiatrist to identify those who do so their omics profile can be compares to other subgroups, I just don't see what a psychiatrist specialism is supposed to offer the study. If it is that then I suppose that might be useful, but I haven't heard any suggestion that MEGA is thinking in that way.

The question still stands, what is the need for having psychiatry specialists involved? I'm very open to MEGA giving me a good reason.

 

[JohnCB]

Presumably this means no referral to NHS clinics for severely ill patients, or those patients who do not think that CBT and GET make any sense. Further evidence that recruiting from NHS clinics is going to result in a biased sample.

This was my experience. A few years ago, my then GP (she has now retired sadly) referred me to an NHS CFS clinic. She understood that I was seriously and wanted me to have appropriate medical treatment. She wanted me to see a doctor who understood my condition and she had assumed that I would see a doctor there. Out of curiosity I found the web page for the clinic and I phoned them. The woman who replied explained that there was no doctor there, just physio and occupational therapists and psychologists. Also it would not be appropriate for me to go as I was not able to travel there on a weekly basis, as doing so would make me more ill. My GP agreed it was not what she had intended when I told of this and cancelled the referral after speaking to the clinic herself.

So if MEGA is recruiting solely from NHS clinics then it won't learn anything about me and people in a similar condition.

 

[trishrhymes]

The last contact i had with my nearest ME clinic, they were offering diagnosis by a GP who was completely clueless about ME, then an occupational therapist offering help with pacing and relaxation. I had a few home visits from her - she was lovely but had no idea how to help, since I already knew more than she did. When she started telling me about this wonderful new treatment called the Lightening Process she'd been learning about, I gave up and never contacted them again.

 

[Simon]

I think fukuda select a sicker patient group whereas NICE are as someone said 50 shades of fatigue. Fukuda are superior therefore to me although deeply flawed with PEM only optional. I would imAgine NICE will select a broader fatigue cohort but I don't think NICE guidelines as a criteria have been subject to much critical interest.

Why do you think Fukuda is so superior to NICE? AFAIK, there's precious little data on NICE cohorts, but I'd be interested.

I don't doubt there are researchers in the UK who'd love to get to work on this illness (some of them maybe on this forum too), but we're not dealing with them alone here, and that's the trouble.

I'm not sure there are many that would 'love' to do so, that's the whole problem. And people like Stehen Holgate have worked had to bring in new talent. I'm not keen on driving them away by making their lives really difficult.

The UK isn't ready for large scale biomedical research. The BPS model has failed to produce any results as demonstrated by a critical evaluation of the PACE trial, but it continues to exert influence.

I'd say we need large scale biomed research precisely to find out what's really causing our illness, and end the influence of the BPS model. That's a major reasonn I'm keen to see such an important study go eahead.

Yes, we really need to keep making this point to the scientists - these people are the most interesting, and if you are are not studying them then you are not studying ME.

OK, but if that's the case you can forget all the VO2 max exercise studies (who's patients are generally the mildest patients), the cytokine work from Lipkin and Hornig, all the NK cell findings, the latest Naviaux metabolomics findings: pretty much every published finding to date. There may well be a stronger signal from severe patients, and I'm keeen they are studied. But one complication is that inactivity due to bedrest is likely to cause a strong biological signal itself (while not in any way causing the disease), making such studies harder to interpret.

A very large study is well place to detect smaller effects from more typical patients.

 

[JoanDublin]

This was my experience. A few years ago, my then GP (she has now retired sadly) referred me to an NHS CFS clinic. She understood that I was seriously and wanted me to have appropriate medical treatment. She wanted me to see a doctor who understood my condition and she had assumed that I would see a doctor there. Out of curiosity I found the web page for the clinic and I phoned them. The woman who replied explained that there was no doctor there, just physio and occupational therapists and psychologists. Also it would not be appropriate for me to go as I was not able to travel there on a weekly basis, as doing so would make me more ill. My GP agreed it was not what she had intended when I told of this and cancelled the referral after speaking to the clinic herself.

So if MEGA is recruiting solely from NHS clinics then it won't learn anything about me and people in a similar condition.

Just heartbreaking to read this. Thoroughly neglectful. THIS is the reason I wouldnt touch this research with a bargepole and I dont know how any ME charity worth its salt can be associated with it. Decades more of this type of behaviour is on the cards if we dont draw the line here

 

[medfeb]

You all know MEGA and the U.K. situation much better than I do so please don't hesitate to tell me where I am not understanding something...

As MEGA are now talking about a biorepository,, which sounds a lot like a biobank to me, I'd hope the would consult with the UK mecfs biobank on how to go about this. But the mecfs biobank, like MEGA, draws from NHS clinics (I didnt spot anyone complaining about that, but maybe I missed it) and MEGA will define patients according to multiple criteria. All biobank samples meet Fukuda and most meet Canadian; for MEGA all will meet NICE (I'm not sure which is 'better' between Fukuda and NICE, neither are ideal in my book) and will also diagnose according to other criteria..

So ultimately they will be very similar - as I understand from the Q&A, researchers could pull out a sample of CCC-only patients from both.

From what I have read, the London biobank is reaching out to severe ME patients to collect samples. Is that true and has MEGA implemented a strategy for this?

Re Fukuda versus CCC - totally agree that Fukuda is not good for research. Advocates in the U.S. have been pushing NIH to use a criteria that requires hallmark symptoms as seen in CCC and ME-ICC. One of the concerns raised with the initial plans for the NIH Intramural study was that it was using the Reeves 2005 definition - Reeves uses the Fukuda inclusion and exclusion criteria but then uses a set of assessment tools that resulted in a 6 fold increase in prevalence over Jason's study and also the inclusion of more mental illness. NIH has since said they are using CCC

Worth mentioning that the uk biobank selected on Fukuda, but most of those still met Canadian. I think Lenny Jason has done a similar study finding the same. So I don't think there's any good evidence that using looser criteria (Fukuda or NICE) will exclude patients with a tighter criteria such as Canadian.

I wonder to what extent that depends on how NICE is applied in actual clinical practice by the NHS clinics. By definition, CFS is medically unexplained chronic fatigue. To what extent do the clinics exclude patients from a diagnosis of NICE CFS who have evidence of e..g. neurological or immunological impairment? It would be important to know how they apply exclusion criteria both at the initial visit and over time. The same is/has been true of Fukuda. The CDC CFS website used to say that a diagnosis by CCC was not the same as a diagnosis of CFS since CCC included neurological symptoms that were considered exclusionary for CFS.

Yes, we need more detail. Eg willl they use Lenny Jason's DePaul symptom questionnaire to diagnose Canadian, as several groups do. The biobank used its own unpublished questionnaire to categorise patients as meeting Canadian criteria (that's not ideal either - but then many of the issues raised about MEGA apply to many other studies).

As for PEM, I think that's a very important question. Jason has done some of the best work on this, but I'm not totally convinced by his questionnaire: his analysis concludes that the single best q for defining PEM is "a dead heavy feeling in the muscles". I wonder how many people here would agree with that.

So I think these are all important issues, and we need to know how MEGA are doing this - but I'm not sure there are lots of perfect solutions out there already.

Completely agree we don't yet have perfect solutions for assessing critical factors in this disease and we need to have these in all these studies. Some thoughts... NIH has announced a focus group to collect information on PEM which will be used as interview tool for assessing post-exertional malaise in its intramural study. (Patient selection will be key there as well and ideally, the outcome will be compared to the DePaul questionnaire.)

NIH also has an initiative for common data elements that is intended to drive consistency across studies on how symptoms are assessed and what data is collected. They are running a session on this at the IACFS/ME conference - abstract below) Perhaps an opportunity to drive some international consistency.

My one concern with the common data elements approach is that CDC has in the past stated that as long as you collect common data elements, it doesn't matter what definition you use. While I appreciate the value of common data elements, I wonder how well we will be able to harness the future evidence base if every published study continues to use the same disease label for all these different definitions. Assuming I got it right, I think that's one of the things the London biobank is doing right - samples that meet only Fukuda and not CCC are labeled differently than those that meet CCC.

One final thought - MEGA has set a goal of a large number of patients and then is applying a broad definition to achieve those numbers. I've read the NICE criteria but I can't tell whether PEM is mandatory or not and how its assessed. Based on concerns raised here, it sounds like NICE's focus, like Oxford and Fukuda, is still on medically unexplained chronic fatigue. Is that true?

Assuming for the moment that NICE does not require PEM as we understand PEM... If researchers were running a big data study for multiple sclerosis, would they use a catch-all diagnosis of medically unexplained chronic fatigue to boost the recruitment numbers, knowing that some of those patients would not have MS? I'd assume they'd take their best stab at defining an MS cohort, knowing up front that that would dictate how many patients they get and that if they were to add additional groups, they'd carefully decide what groups to add and treat them as comparator groups, not part of the MS group.

So why not start with a research definition that requires the hallmark symptoms of ME? If one of the goals is to compare the underlying biology of ME patients to fatigued patients who do not have ME, what about including some patients with medically explained fatigue, like MS?

I get the point that Dr. Shepherd made about proving once and for all that the NICE criteria contain unrelated groups that need to be separated. That's a really important political problem in the U.K. It may be necessary, but this seems like an expensive and time-consuming way to solve that problem especially given all the reports and science that have come out in the last 2-3 years. I imagine the value delivered by the study will hinge on how well it selects and characterizes ME patients and how many and how broad a cross section of ME patients it is able to recruit.


IACFS/ME Conference session
Common Data Elements (CDEs) for Standardized Testing and Clinical Studies
Chair: Vicky Whittemore, Ph.D.
Program Director, Channels, Synapses and Circuits
National Institute of Neurological Disorders and Stroke

The National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health and the Center for Disease Control and Prevention (CDC) will partner to develop common data elements (CDEs) for standardized testing and common data elements to be recorded in clinical studies/trials of individuals with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The development of CDEs for ME/CFS will facilitate the comparison of results across studies and help to standardize analysis. The session will be led by NINDS and CDC Program Staff to discuss the timeline and process for developing the CDEs and to obtain feedback and input from ME/CFS stakeholders.