Counter petition to the MEGA petition, brainstorming stage

Jo Best

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I think an important difference between the deep dive, big data, hypothesis-free approach of Ron Davis and Rob Naviaux is that they began with a small well-characterised patient group.

Ron Davis, in particular, chose to study severely ill patients because he reasoned that markers would be stronger in those patients, and a similar point was made about the small number of patients in the proposed NIH study of post-viral ME/CFS, that if nothing useful is found in an intensive study of a small number of well-characterised patients, then it probably isn't there.

I have never seen the like of this petitioning by researchers for public support (anyone can sign a petition) in order to obtain funds. I've also never seen signatories to a petition add comments to the effect that they have signed on trust.

The whole thing looks unprofessional and unethical to me, and also reflects the confusion that I see among the members of the CMRC about the basics of the disease/s under investigation.

I agree with the observation made by Ron Davis at IIMEC11 -

“Cancer is complicated. ME/CFS is complicated”.

I do get that a study of 12,000 ill-defined patients may clarify some of that confusion and help sort out the diagnostic mess created by the CFS Oxford Criteria and CFS/ME NICE guideline, but the main issue at hand is the petition, which has had the effect of a deep dive in my confidence that the MEGA study will deliver.

My advice to researchers interested in helping to sort out the complexities of ME/CFS is to request involvement in the Invest in ME Biomedical Research into ME Colloquium. To quote the charity -

"In fact, the mood amongst researchers has improved since we began our colloquiums and fortunately we have many researchers now interested in entering this research area - as witnessed by the large number of "new" entrants to this research and present at our Colloquium in London in June. We hope more will attend in the 2017 Colloquium."
 

BurnA

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MEGA Q&A said:
This means patients with other causes of fatigue will not be recruited including (for example): those with thyroid disease, diabetes or depression that is sufficiently severe to explain their fatigue
.

MEGA Q&A said:
What data will you collect?

We will collect symptom data on all patients to allow us to identify which patients will be identified as having CFS/ME using different diagnoses. We will also include data on fatigue, disability, anxiety and depression.
.
Anxiety ? Depression?
 

AndyPR

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So I've just really appreciated that, taking this update at face value, I wouldn't qualify for inclusion in the study, on the basis that I last attended a clinic 10 years ago. In that time I have gone from mild to moderate and am no longer working but "no clinic, no inclusion". And they'd still like me to sign the petition to support this....
 

snowathlete

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So I've just really appreciated that, taking this update at face value, I wouldn't qualify for inclusion in the study, on the basis that I last attended a clinic 10 years ago. In that time I have gone from mild to moderate and am no longer working but "no clinic, no inclusion". And they'd still like me to sign the petition to support this....
Same here. I quickly exhausted the value my CFS clinic has to offer me and when they made me bed bound by encouraging me to do GET I decided it was a negative relationship I would not maintain. So you'll get those who stick around (who may not have ME) and those who are new to it and don't know what is in their interests yet.
 

thegodofpleasure

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I've posted this comment on the Change.org petition update webpage:

https://www.change.org/p/support-th...ation-to-major-uk-research-funders/u/18056402

I would like to register the following concerns about the proposed M.E./CFS Epidemiology and Genomics Alliance (MEGA) research study:
1. That a draft trial protocol should be published and a formal consultation subsequently undertaken, with patients, advocates and other interested parties, before any application for funding is made to the Medical Research
Council.

2. That any researcher who has previously been involved in the now discredited PACE trial (or who has supported the bio-psychosocial model of M.E /cfs) should not be involved in any way in the study.

3. That the illness definition which is used to recruit patients onto the trial shall be the Canadian Consensus criteria (or a derivative thereof), which includes Post-exertional malaise (worsening of symptoms) as a mandatory
requirement for inclusion.

4. That the researchers involved in the study shall fully commit to the principles of data sharing with regards to any published work and complete transparency with regards to the conduct of the trial. There should be no attempt to use the excuse of a lack of patient consent to somehow keep data hidden - as was the case in the PACE trial.

5. That the trial will be conducted in accordance with the final (published) version of the trial protocol, with no post-hoc changes or subsequent deviations.

6. That a representative proportion of severely ill patients should be included in the study.

7. That a properly meaningful patient engagement group should be set up, membership of which is not confined to members of charities who are already part of the CMRC.
 
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trishrhymes

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I'm not sure your point 5 about trial protocol makes sense for this kind of study, since it is an exploratory data search, not a trial of any treatment, so outcome measures will be genetic, metabolic etc data, not responses to treatment. I understand why you have included this point after the PACE fiasco, and I made the same mistake at first until someone put me straight!
 

thegodofpleasure

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I'm not sure your point 5 about trial protocol makes sense for this kind of study, since it is an exploratory data search, not a trial of any treatment, so outcome measures will be genetic, metabolic etc data, not responses to treatment. I understand why you have included this point after the PACE fiasco, and I made the same mistake at first until someone put me straight!
O.K. point taken. But to some extent it depends on what's in their final written proposal.
In the circumstances, it's a perfectly reasonable (distrustful) response to their ham-fisted handling of the situation.
There's no knowing what jiggery pokery will go on if they're given free reign to do so - especially with Crawley and White involved.
 

Countrygirl

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I just want to chime in with my experiences of receiving calls from people who have been given a diagnosis of 'CFS' from the fatigue clinics. Several years ago the people who phoned for information and support usually gave a clear medical history of ME. Their accounts were typical of Ramsey, ICC or CCC ME.

However, in recent years, few of the people I speak to resemble ME patients and clearly, in my opinion, do not have ME, but some other condition that I don't recognise. They tell me they definitely have ME as 'the psychiatrist' told them so. In my opinion, they are being misled.

I rang the local CFS clinic which is run from the local old Victorian lunatic asylum and they assured me that CFS is a mental health condition and not a physical illness. A doctor told me a few weeks ago that CFS or ME is just a label 'we give to people with mental health problems and that it doesn't exist as a physical illness'. It is from this group of patients diagnosed by doctors with this misunderstanding of the illness from which the MEGA study will select their subjects . How can we possibly have confidence in their selection criteria? Obviously we can't. It is a complete mess.
 

TiredSam

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With 250,000 sufferers in the UK, the priority should be how to identify (and help?) them. Once that's done, we can talk about inclusion criteria for the MEGA study. Using the CCC to identify less than 5% of sufferers in the UK for a study of 12,000 - doable innit? If not, go back to the drawing board and get that sorted. Once you have, you can study them and identify and play around with your subsets from them. Using the current completely broken system to recruit patients makes no sense at all, due to bias, cherry picking, including lots of people with other illnesses and missing lots of people (severe, long-term, decided not to bother with the system in the UK for self-protection) with ME.

Will Esther Crawley be putting pressure on the parents of children with ME to join the study under threat of reporting them to the authorities and having their kids rediagnosed with mental illness / taken away? There are accounts on PR from parents who have suffered direct experience of EC which confirm that that is her MO.
 
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I just want to chime in with my experiences of receiving calls from people who have been given a diagnosis of 'CFS' from the fatigue clinics. Several years ago the people who phoned for information and support usually gave a clear medical history of ME. Their accounts were typical of Ramsey, ICC or CCC ME.

However, in recent years, few of the people I speak to resemble ME patients and clearly, in my opinion, do not have ME, but some other condition that I don't recognise. They tell me they definitely have ME as 'the psychiatrist' told them so. In my opinion, they are being misled.

I rang the local CFS clinic which is run from the local old Victorian lunatic asylum and they assured me that CFS is a mental health condition and not a physical illness. A doctor told me a few weeks ago that CFS or ME is just a label 'we give to people with mental health problems and that it doesn't exist as a physical illness'. It is from this group of patients diagnosed by doctors with this misunderstanding of the illness from which the MEGA study will select their subjects . How can we possibly have confidence in their selection criteria? Obviously we can't. It is a complete mess.
I don't believe that this account of your local ME/CFS service (are you able to say where it is?) is typical of the overall picture of the ME/CFS clinics/services

The MEA receives a constant stream of requests from people who are desperate for a diagnosis of what is best described as symptoms that may or may not be ME/CFS

Consequently I am (or we are) referring large numbers of people to these NHS clinics - as this is the only way of getting a more thorough clinical assessment or diagnosis if the GP is unable to do so

We also obviously receive a large amount of patient feedback from people who go to these NHS clinics

The overall picture is actually very mixed - we receive excellent or good feedback in some cases and mediocre or negative feedback in others

As a quick practical example, I did a radio programme for BBC Scotland (where referral services are almost non existent) a few weeks ago and while on air we received a number of unsolicited and really quite positive comments about one service there in Edinburgh. And whenever this service is discussed on our Facebook page there are always people who express positive experiences

But, as I say, the picture is very mixed

MEA directory of NHS referral services for ME/CFS:

http://www.meassociation.org.uk/nhs-specialist-services-throughout-the-uk/
 

Countrygirl

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I don't believe that this account of your local ME/CFS service (are you able to say where it is?) is typical of the overall picture of the ME/CFS clinics/services

/
@charles shepherd Yes, it is the Devon clinic. I rang them about a year ago, maybe less and was given this information.

The following quote I used was from an A&E doctor from the Wonford, which is adjacent to the building from which the clinic is run. I had just been taken in with cardiac problems and he warned me that if my diagnosis was discovered that ' my colleagues won't treat you kindly'.

A local GP from the same area phoned me to ask for advice on ME as he believed he had developed the illness and told me that he was fearful of his colleagues discovering that he had ME as, to use his exact words, ' Doctors regard people with ME with even more contempt than they do people with depression'.

It would be brilliant if the MEA could promote some medical education about ME in East Devon as it still seems to be somewhat of a medical wilderness.
 
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Info on Devon ME/CFS service from MEA website below

We receive very little feedback on this particular service

From memory, it has normally been more positive than negative

You could start a discussion on the MEA Facebook page if you want to to get a better idea of the overall picture:

Devon

South and West Devon CFS/ME Service is run on behalf of Torbay and Southern Devon Health and Care NHS Trust at the following address: 3rd Floor, Union House, Union Street, Torquay TQ1 3YA. Administrator: Louise Swann, tel: 01803 219 859 fax: 01803 219 893 email:swdevoncfsme.sdhc@nhs.net

The EXETER EAST, MID AND NORTH DEVON CFS/ME Service is based at the Arlington Centre, Whipton Hospital, Hospital Lane, Whipton, Exeter EX1 3RB, tel: 01392 208 614

The PLYMOUTH service is run on behalf of Sentinel Healthcare SouthWest Community Interest Company at the following address: Express Diagnostics & Treatment Centre, Plymouth Science Park, Plymouth PL6 8BU. Administrator: Trudi, tel: 0845 155 8297 Email:PCHCIC.SentinelClinicalTreatmentService@nhs.net

The Service Manager/Senior CFS/ME Specialist for both the above services covering the whole of the South and West of Devon.
The team currently consists of a medical lead Dr Robert Gardner, Senior specialist Occupational therapists, two specialist Occupational Therapists and two administrators (as below).
The service is an adult community service providing, assessment, diagnosis and treatment for individuals suffering the complex symptoms of CFS/ME. The service is offered where appropriate to all levels of CFS/ME, mild, moderate and severe. 
Along with the treatment approaches advised by NICE guidelines this service is also part of a national group auditing and implementing research and evidenced-based Mindfulness CBT approaches, to support patients psychologically with coping with this condition. The service is also able to provide extensive knowledge gained through patient experience and reporting.