Petition: Opposing MEGA

[charles shepherd]

Did the petition do this? When I read it through yesterday, that was not the implication that I took from it.

Will have to give it another read.

The petition contains 13 short paras of explanation

6/13 paras are devoted to associations with the PACE trial and/or the BPS model of causation and treatment

IMHO there is a clear implication that many members of the MEGA planning group are sympathetic to the BPS model and/or were involved in the PACE trial - which is NOT the case

So I don't think this can be regarded as a balanced summary of the pros and cons to the MEGA study - in fact, I don't see any meaningful mention of any possible advantages of employing these new technologies to help identify the various clinical phenotypes that come under the current (very unsatisfactory) NICE umbrella of ME/CFS

These are the 7 paras:

A closer look at the MEGA petition reveals that key members and advisors of MEGA are involved in the discredited PACE trial, and the MAGENTA trial in children with ME/CFS which follows from the PACE trial, run by leaders of the bio-psycho-social (BPS) movement known collectively as 'The Wessely School'.

The BPS illness model of ME/CFS assumes that biological abnormalities and physical symptoms are caused or maintained by psychological or social problems and may be treated by changing the patient's thoughts and behaviours.

Decades of research shows that no matter how much 'bio' is found in ME/CFS (plenty has been found) it is interpreted by BPS proponents as due to psychosocial causes and amenable to behavioural therapies rather than signs of disease suffered through no fault of the patient or carer.

The BPS researchers and representatives involved in MEGA have already wasted millions of pounds of research funds in attempts to validate their model in ME/CFS by providing policy-based evidence for the psychosocial treatments recommended by the UK National Institute of Health and Care Excellence (NICE) prolonging suffering and causing immeasurable harm to patients and families.

There is no further room for The Wessely School, BPS model, or those advised by The Wessely School, in any context associated with the disease Myalgic Encephalomyelitis.

Following the Tribunal Decision published August 2016 upholding the decision by the Information Commissioner in favour of Matthees and providing for the release of raw data from the PACE Trial, which has subsequently proved that Trial to be a sham, it would be unreasonable to trust the very same people to have the best interests of patients at heart.

 

[JoanDublin]

Nobody has implied or stated that the biomedical scientists were involved in the PACE studies. It's very disingenuous to say that. In fact people have been very, very clear about WHO was involved in PACE, WHO are proponents of the BPS model (one only has to look at their published research to see this) and WHO is currently leading the Magenta project - GET for kids.

 

[Jan]

'I can fully understand the comments, criticisms and questions that have been raised by the patient community in relation to the MEGA study, and some of the doctors involved. I have been forwarding this feedback to my colleagues on the Board of the CMRC'

Thank you Dr Shepherd you are the first doctor to actually say this. Hundreds of comments have been put on the MEGA petition, but we are getting no response.

Who are the 4 people spearheading MEGA? We have been led to believe it's Esther Crawley, one of her research bods, Sonia Chowdhury and Julia Newton? Are we wrong in this assumption? It's the fact that these people are running the show that's at issue, not any of the bio doctors. This is the reason over 800 people have signed the OMEGA petition. I really don't think they will have the support of the patient community whilst Crawley, her research bod, and Chowdhury and involved. Why are these people running the show? Please give us some answers.

 

[Esther12]

The petition contains 13 short paras of explanation

6/13 paras are devoted to associations with the PACE trial and/or the BPS model of causation and treatment

IMHO there is a clear implication that many members of the MEGA planning group are sympathetic to the BPS model and/or were involved in the PACE trial - which is NOT the case

So I don't think this can be regarded as a balanced summary of the pros and cons to the MEGA study - in fact, I don't see any meaningful mention of any possible advantages of employing these new technologies to help identify the various clinical phenotypes that come under the current (very unsatisfactory) NICE umbrella of ME/CFS

Thanks for the explanation, but to me what you point to just reflects the importance that many (myself included) attach to the involvement of people like Esther Crawley and Peter White. I don't see it as carrying any implication about those who were not involved in PACE or the biopsychosocial approach to ME/CFS.

Generally, petitions aren't balanced in the way that they make their case. The pro-MEGA petition made no mention of PACE or the problems with the biopsychosocial approach to ME/CFS. Didn't MEA promote that petition without criticism?

 

[A.B.]

I find it poor communication to have a study seeking patient support and feedback, without knowing who is actually in charge. We want to speak directly to this person. If it turns out to be Crawley, this project is dead, and a lot of signatories are going to feel deceived. Is this why we are not told who is in charge?

Transparency creates trust. Lack of transparency, in the context of prior abuse and misconduct creates a large amount of suspicion.

 

[Sidereal]

Who is the principal investigator of the study? If it hasn't been decided yet that's fine but if it has and it's Crawley then that should have been communicated to the patients when their signatures/support was solicited.

 

[snowathlete]

@charles shepherd - assuming I've got it right, AfME and AYME have a role in the study itself but MEA and others don't? If that is wrong, please feel to correct me. If it is right though then can I ask how it was decided by the CMRC which charities would be involved in MEGA directly? Although I don't agree with everything you say on every topic, I certainly trust you and the MEA a damn sight more than I do AfME and AYME, and I think that is probably a position shared by many, so I would have been more comfortable if it was the MEA at the heart of it instead.

 

[Sidereal]

@charles shepherd - assuming I've got it right, AfME and AYME have a role in the study itself but MEA and others don't? If that is wrong, please feel to correct me. If it is right though then can I ask how it was decided by the CMRC which charities would be involved in MEGA directly? Although I don't agree with everything you say on every topic, I certainly trust you and the MEA a damn sight more than I do AfME and AYME, and I think that is probably a position shared by many, so I would have been more comfortable if it was the MEA at the heart of it instead.

Perhaps AfME and AYME are getting rewarded for being complicit in the PACE scandal and the biopsychosocial model whereas the MEA who have been critical of those things don't get a say.

 

[charles shepherd]

This is going to be brief as I need to eat…..and I am not a public spokesman for the MEGA research study!

In relation to the various questions above about the people involved in MEGA:

If you have been following this research from the very start (and the CMRC Minutes are in the public domain - along with Stephen Holgate's presentations to the 3 consecutive CMRC conferences), you will know that the idea and impetus for this 'big data' study came from Professor Stephen Holgate

Professor Holgate and other members of the CMRC Board then discussed which experts in -omics etc should be approached to attend a Workshop and possibly then join a MEGA planning group

The Workshop took place in Bristol earlier this year and a planning group was formed. The names of al members are in the public domain and in my most recent posting. My understanding is that the PI for the study has not yet been agreed.

So key decisions about protocol etc are discussed and made by this planning group - as happens with many research studies and clinical trials. Professor Holgate is still playing a leading role here.

As with most planning groups, the membership is discussed and made by the group - although additional names may be suggested by the CMRC

The 4 charity members of the CMRC took a decision to select one member to be actively involved with the MEGA study and to attend the Workshop in Bristol. We agreed to ask Sonya to take on this role as she was able to attend the Workshop in Bristol and has the administrative support to take on yet more work. My voluntary workload is already enormous and there is a limit to the amount I can now add to this. Sonya is the current charity rep on the group.

A patent liaison group will be formed (as mentioned in the recent FAQ) but the role and composition has not yet been discussed and decided. My own view is that this group should include people who are not members of the four CMRC charities and that we should have someone who can provide constructive criticism

 

[jodie100]

I just don't understand the point of this Omega petition at all. I feel it is so unfair to people with M.E. to be trying to block research like Mega for no reason without giving it a chance to even articulate what it is about. Even if researchers like Profs White and Crawley were involved it would still be biomedical research and they might actually have worthwhile contributions to make having worked extensively with M.E. patients. Metabolomics, genomics etc. experts will all be reporting based on what they find in their research irrespective of the views of who else is involved in the overall research.

 

[BurnA]

Thanks for you continued engagement here Dr. Shepherd, I don't understand the following.

4 In order to do this research, blood samples will need to be taken from the wide range of people who have ME, ME/CFS and some form of undiagnosed chronic fatigue. You cannot do this type of study by restricting the sample size to people who just have one of the favoured research definitions for ME or ME/CFS if you want to find good evidence of sub-grouping and separation from undiagnosed chronic fatigue

I am struggling to understand why " some form of undiagnosed fatigue" needs to be included.

When you say " if you want to find good evidence of subgrouping" - is that the stated aim of MEGA- to find subgroups of fatigued people ?

Don't we already have a means to separate from undiagnosed fatigue, what's wrong with just using a few internationally recognised diagnostic criteria ?

 

[BurnA]

I just don't understand the point of this Omega petition at all. I feel it is so unfair to people with M.E. to be trying to block research like Mega for no reason without giving it a chance to even articulate what it is about. Even if researchers like Profs White and Crawley were involved it would still be biomedical research and they might actually have worthwhile contributions to make having worked extensively with M.E. patients. Metabolomics, genomics etc. experts will all be reporting based on what they find in their research irrespective of the views of who does the research.

For no reason?

I think we would all welcome some articulation from MEGA, the only people who seem to be preventing this are MEGA themselves.

 

[AndyPR]

Thanks for you continued engagement here Dr. Shepherd, I don't understand the following.


I am struggling to understand why " some form of undiagnosed fatigue" needs to be included.

When you say " if you want to find good evidence of subgrouping" - is that the stated aim of MEGA- to find subgroups of fatigued people ?

Don't we already have a means to separate from undiagnosed fatigue, what's wrong with just using a few internationally recognised diagnostic criteria ?

Chris Ponting, in response to a question about selection criteria, had the following to say

The selection of individuals for this study is critical and all that I have heard on this makes me believe that post-exertional malaise criteria should lie at the heart of this. The patient advisory groups that will be set up need to have a strong voice on this issue.

so somewhat mixed messages at the moment.

His blog and Q&A can be found here https://www.change.org/p/support-th...ation-to-major-uk-research-funders/u/18203963

 

[Esther12]

I just don't understand the point of this Omega petition at all. I feel it is so unfair to people with M.E. to be trying to block research like Mega for no reason without giving it a chance to even articulate what it is about. Even if researchers like Profs White and Crawley were involved it would still be biomedical research and they might actually have worthwhile contributions to make having worked extensively with M.E. patients. Metabolomics, genomics etc. experts will all be reporting based on what they find in their research irrespective of the views of who does the research.

But with PACE people were arguing that this was the research which would show the value of pacing. It is really difficult to get to grips with all the details of, and possible problems with, a research project like this. To some extent, we need to be able to trust the researchers involved, but White and Crawley have both shown that they cannot be trusted.

 

[BurnA]

Chris Ponting, in response to a question about selection criteria, had the following to say

so somewhat mixed messages at the moment.

His blog and Q&A can be found here https://www.change.org/p/support-th...ation-to-major-uk-research-funders/u/18203963

Thanks.
Someone seems to get it ....

 

[Snowdrop]

I just don't understand the point of this Omega petition at all. I feel it is so unfair to people with M.E. to be trying to block research like Mega for no reason without giving it a chance to even articulate what it is about. Even if researchers like Profs White and Crawley were involved it would still be biomedical research and they might actually have worthwhile contributions to make having worked extensively with M.E. patients. Metabolomics, genomics etc. experts will all be reporting based on what they find in their research irrespective of the views of who else is involved in the overall research.

@jodie100 The MEGA study will include 10,000 adults and 2,000 children. One big issue with the study is how likely will a number of participants that large represent true ME and not be a study of fatigue. esp if Esther Crawley is the gatekeeper for entry of trial participants. Imagine how devastating it would be to have a study this large NOT properly studying people who have clear symptoms of ME and not just fatigue. The first rate bio researchers have not any experience with ME they are relying on the 'ME experts' to tell them.

 

[charles shepherd]

Thanks for you continued engagement here Dr. Shepherd, I don't understand the following.


I am struggling to understand why " some form of undiagnosed fatigue" needs to be included.

When you say " if you want to find good evidence of subgrouping" - is that the stated aim of MEGA- to find subgroups of fatigued people ?

Don't we already have a means to separate from undiagnosed fatigue, what's wrong with just using a few internationally recognised diagnostic criteria ?

If researchers in -omics can find a consistent abnormality (or abnormalities) in people with (say) Canadian defined ME/CFS, and believe that the abnormality(or abnormalities) could represent be a diagnostic biomarker then they also need to find out if the abnormality is also present in healthy matched controls, people who have fatigue as part of another condition (e.g. MS), people with undiagnosed chronic fatigue etc. If the abnormality is unique to the ME/CFS cohort, then they may have found a diagnostic biomarker - which would be a really useful discovery. You cannot come to this conclusion without establishing that an abnormality is NOT present in other medical conditions - especially those which overlap in some way with ME/CFS/

 

[BurnA]

If researchers in -omics can find a consistent abnormality (or abnormalities) in people with (say) Canadian defined ME/CFS, and believe that the abnormality(or abnormalities) could represent be a diagnostic biomarker then they also need to find out if the abnormality is also present in healthy matched controls, people who have fatigue as part of another condition (e.g. MS), people with undiagnosed chronic fatigue etc. If the abnormality is unique to the ME/CFS cohort, then they may have found a diagnostic biomarker - which would be a really useful discovery. You cannot come to this conclusion without establishing that an abnormality is NOT present in other medical conditions - especially those which overlap in some way with ME/CFS/

Thanks but how does that align with what Chris Ponting is saying

The selection of individuals for this study is critical and all that I have heard on this makes me believe that post-exertional malaise criteria should lie at the heart of this. The patient advisory groups that will be set up need to have a strong voice on this issue.

Yes, adding a person who clearly does not have ME/CFS will reduce the study’s power

.

 

[snowathlete]

If researchers in -omics can find a consistent abnormality (or abnormalities) in people with (say) Canadian defined ME/CFS, and believe that the abnormality(or abnormalities) could represent be a diagnostic biomarker then they also need to find out if the abnormality is also present in healthy matched controls, people who have fatigue as part of another condition (e.g. MS), people with undiagnosed chronic fatigue etc. If the abnormality is unique to the ME/CFS cohort, then they may have found a diagnostic biomarker - which would be a really useful discovery. You cannot come to this conclusion without establishing that an abnormality is NOT present in other medical conditions - especially those which overlap in some way with ME/CFS/

If this is one of the aims then this isn't really much of an ME/CFS study after all. What you're describing is a fatigue study which includes CFS. If that is it then it makes sense to include people with specific diseases that have a fatigue component...but to include chronic undiagnosed fatigue it would be better to make that a distinct recruitment group, not make the whole group including ME/CFS so vague that it encompasses chronic undiagnosed fatigue also. Why not have ME/CFS (PEM), MS fatigue, Cancer fatigue, IBD fatigue, etc. if the study wants to be a fatigue study?

 

[Barry53]

Surely the primary objection, which I fully agree with, is to not include any individuals who are known to have engaged in corrupt practices; those involved with PACE inevitably fall into this category. The issue should not be about excluding certain clinical disciplines. If we want honest, open, high integrity science, then it must not be pre-loaded by insisting some disciplines are excluded; that would be throwing the baby out with the bath water.

We really must not conflate the two separate issues of corrupt individuals, versus a clinical discipline those corrupt individuals have brought into disrepute. Insisting on excluding corrupt individuals is absolutely right and wholly justifiable, from any reasonable person's standpoint. Insisting on excluding a medical discipline en masse, just gives the impression to others we want to skew the results in favour of a biomedical result. Actually a biomedical outcome would carry far more weight if a psychiatric specialist was on the team ... but ONLY if that person is of the highest integrity, the same as all the other researchers need to be.