Petition: Opposing MEGA

[Jo Best]

Having caught up with this thread now I don't think this was posted - https://opposingmega.wordpress.com/2016/10/24/1000-supporters-in-4-days-find-out-why/

 

[charles shepherd]

Thanks

I just checked with Dr Eliana Lacerda from the biobank who confirmed that while most cases came from GPs, some (non-severe) cases case from clinics including the Norfolk and Sulfolk ME/CFS service, the Department of Clinical immunology of the Royal Free Hospital and the CFS clinic from the Royal London Hospital of Integrated Medicine (RLHIM). Separately, the biobank have stated that severe cases were recruited via Greater London patient support groups.

Reply from Chris Ponting re sampe size:
And interval is a linkage disequilibium chunk of DNA:

Due to the difficulty with recruiting people with severe ME/CFS we did also put out an appeal for volunteers to come forward

And, as has already been stated, everyone whose blood sample is now included in the Biobank has had a VERY THOROUGH clinical assessment (history, examination, blood tests) carried out by a dedicated member of the Biobank team to make sure that they meet with Canadian and Fukuda diagnostic criteria for ME/CFS

CS
(Chair of ME Biobank Steering Grou)

 

[Countrygirl]

I wrote to the chair of the CMRC as was being recommended when this potential project was first announced. My reply totally ignored most of the points i had made. I feel they believe by replying they are ‘engaging with me’ therefore ignoring most of my letter doesn’t matter, this is distant from reality and I’m joining this petition because i feel its the only way to let my objections be heard.

These guys need to learn that we will not tolerate being patronised or ignored.

'They' and 'we' have history! And it is serious stuff.

Members of 'their' team are responsible for inflicting great harm upon us. They need to take this and our concerns seriously.

In my opinion, they need to publicly distance themselves from PACE, its prophets and disciples.

We also need to know if one of PACE's proponents or adherents is destined to be Prof Holgate's successor. (He is of retirement age)

 

[barbc56]

I was talking about the CMRC in general, sometimes i get the impression you are so quick to make excuses you miss entirely what is being said, here. That's a pity.

So, if someone disagrees with you it's okay to be rude and defensive instead of asking for further clarification?

As far as this thread, it seems to have become so sidetracked by all the little details, assumptions, venting and conspiracy theories, that we're losing sight of our main goals. If our complaints are a concern about some of the researchers and the criteria used for selecting patients, then focus on that. IMO that says enough as far as what pertains to this petition. Plain and simple gets the point across.

The above comment cited by Jan, IMO, is rude and unprofessional. Using terms such as” smelling a rat”, “ tainted”, “ peddlers of pseudoscience”, “intellectual embarrassment”, just to name a few, are not effective techniques for persuading others to see our point of view. Sure, the writer may feel better after venting, but what does it say about us? It's a perfect example of how not to be taken seriously.

My fear is that if we aren't careful we may be jeopardizing future research for me/cfs.

Just saying.

 

[lilpink]

GPs are supposed to try and keep up to date with key developments in the conditions that they deal with on a regular basis, including ME/CFS - and most GPs try to do so

But it's not an easy task because all doctors suffer from information overload - I suffer from severe information overload!

I hardly think that GPs can be unaware of the PACE trial and/or the psychosocial campaign with respect to ME/CFS given that it is the same argument and rhetoric that is being promulgated for all 'MUS' conditions to GPs across the country. GPs are currently being actively encouraged and enticed to attend MUS training days and courses in preparation for them receiving psychotherapists to work in or with their surgeries, with the purpose of ensuring that their MUS patients (including ME/CFS sufferers) no longer 'waste' NHS money by being referred to secondary care. All this carefully planned and executed by the Institute of Psychiatry and the 'Wessely School' (Trudie Chalder's PRINCE Trials underway at present is part of this political move). If CS isn't aware of this GP training and these plans maybe he's now too overloaded and too specialist to grasp the wider picture?

 

[TiredSam]

Just trying to catch up after a few days away from the forum and have waded through all 24 pages of this. Looks like we all have our own versions of "the real world".

Seeing as it's up for redrafting I don't see why this:

"3.2.3 Members will be required to sign a declaration that they will not take part in the
harassment or abuse of researchers. Neither will they take part in orchestrated
campaigns against those conducting peer-reviewed research."

Can't be replaced by this:

"3.2.3 Researchers will be required to sign a declaration that they will not take part in the harassment or abuse of sufferers. Neither will they take part in orchestrated
campaigns against those who, whilst being confined to their beds, presume to think or speak."

It would certainly better reflect the real world that PWME have had to deal with for the past three decades.

 

[Valentijn]

As I've already said, NICE will only take serious note of the PACE data re-analysis if it can be turned into a paper for publication, peer reviewed for accuracy (not that this always works) and published in a reputable peer reviewed journal - all of which will take many months

The re-analysis, published or not, was merely the demonstration that post-hoc changes are undesirable for a very good reason. Those changes hoisted a huge red flag which journals, academics, the media, and others chose to ignore. Who with half a brain cell would think that a SF36 Physical Functioning score of 60 (out of 100) even comes close to any rational description of "recovery"?

Various scientific bureaucrats and academics have seriously dropped the ball in accepting or even defending PACE, and their heads should be rolling now. They certainly should not continue to be in any position of responsibility which involves understanding, analyzing, or summarizing scientific research.

If they don't trust the unpublished analysis, they can run the bloody data themselves. It's obvious that it stinks, and they're trying to pretend they don't smell a thing until the "right people" tell them how much it stinks. It's a stupid system which short-changes patients and even harms them.

 

[Jo Best]

@lilpink You may know that MUS may give way to 'Persistent Physical Symptoms' as PPS is a description of what patients have rather than what's missing (supposedly a medical explanation) - because -

Most patients want a positive description of symptoms i.e. an explanation of what it is rather than what is isn’t.

 

[Hutan]

As I've already said, NICE will only take serious note of the PACE data re-analysis if it can be turned into a paper for publication, peer reviewed for accuracy (not that this always works) and published in a reputable peer reviewed journal - all of which will take many months

Actually, it is not necessary to wait for the PACE data re-analysis to be turned into a paper for there to be a peer reviewed paper showing that CBT and GET didn't work in PACE.

The 2.5 year follow up paper clearly showed that (if one reads past the abstract).

I don't really understand why that paper isn't used more often to rebut PACE.

 

[Cinders66]

Thanks

I just checked with Dr Eliana Lacerda from the biobank who confirmed that while most cases came from GPs, some (non-severe) cases case from clinics including the Norfolk and Sulfolk ME/CFS service, the Department of Clinical immunology of the Royal Free Hospital and the CFS clinic from the Royal London Hospital of Integrated Medicine (RLHIM). Separately, the biobank have stated that severe cases were recruited via Greater London patient support groups.

Reply from Chris Ponting re sampe size:
And interval is a linkage disequilibium chunk of DNA:

Briefly: yes if we’re lucky then ‘sore thumb’ GWAS observations could be seen, but there is no chance of convincing funders to do a 1k patient GWAS. They’ve been burnt too frequently with under-powered analyses/grants previously. I also think that the observation that one associated interval can mislead is a good one: far better to have the power to find many associations so that you can find the shared biology among them. (Note that an interval commonly contains many [or even no!] genes. [could be non-coding regulatory region]) I also would guess that the observations seen from a (hypothetical) “clean” 1k would also be seen in a cohort made up of these 1k clean patients plus 10k others who are less well defined.

I'm guessing this is what the CMRC has planned in terms of numbers -1000 meeting stricter ME definitions, a further 10 000 who don't but have a fatiguing or disabling condition.? Can that be called an ME study?

Who is the dr doing the metabolomics side because we are not hearing about that yet? Still so much to learn finalise even before a funding Application can be made...

 

[charles shepherd]

I hardly think that GPs can be unaware of the PACE trial and/or the psychosocial campaign with respect to ME/CFS given that it is the same argument and rhetoric that is being promulgated for all 'MUS' conditions to GPs across the country. GPs are currently being actively encouraged and enticed to attend MUS training days and courses in preparation for them receiving psychotherapists to work in or with their surgeries, with the purpose of ensuring that their MUS patients (including ME/CFS sufferers) no longer 'waste' NHS money by being referred to secondary care. All this carefully planned and executed by the Institute of Psychiatry and the 'Wessely School' (Trudie Chalder's PRINCE Trials underway at present is part of this political move). If CS isn't aware of this GP training and these plans maybe he's now too overloaded and too specialist to grasp the wider picture?

I do actually spend quite a lot of time talking to a wide range of medical colleagues, including GPs - so I have not 'lost touch' with the bigger picture

I receive and/or read some (but not all) of the GP journals and publications (e.g. GP, PULSE, Guidelines in Practice, MIMS, BMJ) - which is where a lot of GPs get their information from - and use their on-line modules on a wide range of illnesses as part of my own continuing professional development

Yes, MUS is a very trendy topic and it is a regular topic at a postgraduate training level. So most GPs are well aware of MUS. In fact, a significant proportion, if asked, would say that ME/CFS is an MUS

There are some GPs who know about PACE but hardly any will have read the Lancet paper, the follow up papers, or the criticism of the PACE trial. The number who are aware of the PACE trial re-analysis is very small indeed. Most GPs who have some knowledge of PACE will still be under the impression that it is a perfectly valid piece of research which supports the use of CBT and GET as safe and effective treatments in ME/CFS - in the same way that NICE currently recommends

 

[charles shepherd]

Briefly: yes if we’re lucky then ‘sore thumb’ GWAS observations could be seen, but there is no chance of convincing funders to do a 1k patient GWAS. They’ve been burnt too frequently with under-powered analyses/grants previously. I also think that the observation that one associated interval can mislead is a good one: far better to have the power to find many associations so that you can find the shared biology among them. (Note that an interval commonly contains many [or even no!] genes. [could be non-coding regulatory region]) I also would guess that the observations seen from a (hypothetical) “clean” 1k would also be seen in a cohort made up of these 1k clean patients plus 10k others who are less well defined.

I'm guessing this is what the CMRC has planned in terms of numbers -1000 meeting stricter ME definitions, a further 10 000 who don't but have a fatiguing or disabling condition.? Can that be called an ME study?

Who is the dr doing the metabolomics side because we are not hearing about that yet? Still so much to learn finalise even before a funding Application can be made...

I think this is the current list of esearch scientists who are currently involved in planning the MEGA study:

* Genomics – Prof George Davey-Smith (Bristol),
Prof Chris Ponting (Edinburgh),
Prof Colin Smith (Brighton)
* Epigenetics – Prof Caroline Relton (Bristol)
* Proteomics – Mr Tony Bartlett (Somalogic)
* Metabolomics – Dr Rick Dunn (Birmingham)
* Routinely collected data – Prof Andrew Morris (Edinburgh)
Prof David Ford (Swansea)
* Infection – Prof Paul Moss (Birmingham)
* Sleep – Prof Jim Horne (Loughborough)
* Pain – Prof Maria Fitzgerald (UCL)
* Autonomic dysfunction - Prof Julia Newton (Newcastle)

First explanatory blog from Professor Chris Ponting:https://www.change.org/.../support-th...ation.../u/18203963 - which focusses on what is called multi-omics

"Multi-omics is the study of multiple genome-scale, often population-based, data sets and it lies at the heart of modern biomedical science. We are interested in carefully linking DNA variants to changes in molecules, processes, cells, organs and individuals. To do so we analyse high-throughput DNA, RNA abundance, DNA-binding, and phenotype (both human and model organism) data from primary tissues as well as from cell lines and single cells. One focus of our research is on genes that are not used to make protein – so called long noncoding RNAs – particularly those that modulate mitochondrial function in different cells and tissues. Other projects are investigating the biology of single cells, specifically neurons, glia and thymic epithelial cells.

 

[TiredSam]

First explanatory blog from Professor Chris Ponting:https://www.change.org/.../support-th...ation.../u/18203963 - which focusses on what is called multi-omics

Dead link for me I'm afraid (get a message saying the page can't be found), don't know if the problem's at my end or the page has been removed.

 

[Countrygirl]

This is the trial that @lilpink mentioned above.

It reads remarkably like the blurb on the MUS chart that Dr Charles S posted this morning in his report of the depressing discussion in the House yesterday about PIP. That chart included ME/CFS, unlike Prof TC's list below, although she includes fibro, so I think we can be confident she intends that ME is part of her PRINCE trial. No doubt this ensures that the lucrative gravy train stays on the rails and is not threatened with derailment by the exposure of the scientific catastrophe that is PACE. I guess it is N.I.C.E. to know that your future financial security is assured, even if it means ensuring that physically very sick patients are not taken seriously and are denied appropriate treatment and social and financial support.



https://clinicaltrials.gov/ct2/show/NCT02426788

Brief Summary: Persistent Physical Symptoms (PPS; also known as medically unexplained symptoms - MUS) is a term used to describe a range of physical health difficulties that people can experience and for which the exact cause is unclear. Between 20 and 40% of patients in primary care, and about 50% in secondary care experience PPS. Not only are PPS common, but the overlap across different patient groups may indicate that these phenomena are transdiagnostic. PPS are associated with profound disability and high health care costs, and if left untreated the prognosis of these patients is poor. There is an accumulating body of evidence demonstrating that cognitive behavioural interventions can reduce levels of symptoms and improve functioning in patients with PPS. A pragmatic RCT was designed to evaluate the clinical and cost-effectiveness of cognitive behavioural therapy (CBT) + Standard Medical Care (SMC) versus Standard Medical Care alone, in the treatment of patients with PPS. The trial will focus on patients with a variety of symptoms (e.g., non-cardiac chest pain, fibromyalgia), across secondary care clinics (e.g., neurology, cardiology, and rheumatology). Patients who have been referred to secondary care in the past six months will also be recruited from General Practice (GP) surgeries.

 

[AndyPR]

‘I would advise that a new steering group be set up for a large and inclusive, data gathering and biomic sequencing and typing study with the major emphasis on the severely affected, who are the most likely to yield clear differences worthy of more intensive study. By all means collect data from a quota of less severely disabled/sick patients as well, but only to the number necessary to provide a control match for each of the seriously ill study subjects. A similar number of healthy controls will also be needed.

‘Thus the size and expense of the study should stem from the maximum number of seriously ill participants for statistical certainty… (plus controls). If that turns out to be a very big cost: then let all patient organisations and researchers get together and lobby for those necessarily big funds to be made available. With the skyrocketing costs of indefinite medical care, I would say that, no matter what the cost of such a project, it will be tiny compared with the costs of the failure to treat, into infinity.’

https://spoonseeker.com/2016/10/27/getting-airborne/

 

[Yogi]

I do actually spend quite a lot of time talking to a wide range of medical colleagues, including GPs - so I have not 'lost touch' with the bigger picture

I receive and/or read some (but not all) of the GP journals and publications (e.g. GP, PULSE, Guidelines in Practice, MIMS, BMJ) - which is where a lot of GPs get their information from - and use their on-line modules on a wide range of illnesses as part of my own continuing professional development

Yes, MUS is a very trendy topic and it is a regular topic at a postgraduate training level. So most GPs are well aware of MUS. In fact, a significant proportion, if asked, would say that ME/CFS is an MUS

There are some GPs who know about PACE but hardly any will have read the Lancet paper, the follow up papers, or the criticism of the PACE trial. The number who are aware of the PACE trial re-analysis is very small indeed. Most GPs who have some knowledge of PACE will still be under the impression that it is a perfectly valid piece of research which supports the use of CBT and GET as safe and effective treatments in ME/CFS - in the same way that NICE currently recommends

Care to comment on the Royal college of surgeon new guidance?

http://forums.phoenixrising.me/inde...he-uk-law-on-consent.41989/page-3#post-779362


Surgeons are worried. Why are ME/CFS doctors and psychiatrists not?

Perhaps some lawsuits will focus their minds on the harms of CBT GET.

 

[Jo Best]

Actually, it is not necessary to wait for the PACE data re-analysis to be turned into a paper for there to be a peer reviewed paper showing that CBT and GET didn't work in PACE.

The 2.5 year follow up paper clearly showed that (if one reads past the abstract).

I don't really understand why that paper isn't used more often to rebut PACE.

I fail to grasp this too. My understanding (or memory) is that even the data published in the first full PACE trial Lancet paper showed no clinically significant difference between CBT and GET compared with SMC alone. So I couldn't understand why NICE wasn't being advised accordingly by the patient representative charities. Then the long-term follow-up confirmed null effect across the treatment arms, yet the emphasis seems to be being given to the patient surveys showing harms, which we know is disregarded by NICE as evidence. The harms are very important, of course, but if it's being argued that harm from CBT or GET is hard to prove, then surely the null effect is enough for NICE to publish an addendum to the clinical guideline, pending full review.

 

[lilpink]

Yes, MUS is a very trendy topic and it is a regular topic at a postgraduate training level. So most GPs are well aware of MUS. In fact, a significant proportion, if asked, would say that ME/CFS is an MUS

You appear to be very accepting and unchallenging of this state of affairs?

I would draw your attention to The BMJ book - ABC of Medically Unexplained Symptoms, (2013) "written by an expert author team" and "ideal for general practitioners, practice nurses and specialist nurses", I'm sure it must be well known to you. Chapter 12, authored by Alison Wearden, is entitled 'Fatigue'. To quote - "Preliminary evidence suggests that both mood disturbance (depression and anxiety) and a tendency to a driven, 'all-or-nothing' approach to managing symptoms, are associated with the progression to a more chronic fatigue state". Need I go on? Well I will because throughout the whole chapter we get psychosocial statements such as - " Patients are unaware that too much rest can be counterproductive, both in terms of cardiovascular and muscular deconditioning and other effects." And "A good evidence base for treating CFS/ME has started to accumulate, and it is now clear that the two treatments that have proven efficacy for the management of CFS/ME are CBT and graded exercise therapy". bla bla In 'Further reading' there are just 4 references - to Burgess and Chalder's book Overcoming Chronic Fatigue, 2005;the NICE guideline 2007; Pemberton and Berry's Fighting Fatigue book of 2009; and Wessely, Hotopf and Sharpe's book - Chronic Fatigue and its Syndromes, 1998.


Like it or not we are now lumped together with a myriad of other 'MUS' conditions, this is what GPs are being taught, this is what is being perpetuated by the Institute of Psychiatry and what is written into the Five year Forward Plan for Mental Health, not physical health, Mental health. ME patients need to wake up and smell the coffee, we need to oppose MEGA for as long as anyone associated with the PACE Trial, the Institute of Psychiatry or the Wessely School, or anyone who has collaborated in research with the same, is involved.

 

[lilpink]

even if it means ensuring that physically very sick patients are not taken seriously and are denied appropriate treatment and social and financial support.

There are some excellent observations at a KingsFund.org thread in response to its recent publication ' Bringing Together Physical and Mental Health. A new frontier for integrated care' (https://www.kingsfund.org.uk/publications/physical-and-mental-health)

That from Mrs E Wenn, patient, ref #545893 makes some very useful comment about the gender bias whilst 'Polly' ref #548243 neatly summarises the double bind anyone with a MUPS diagnosis (including ME) faces and in so doing endorses Countrygirl's assertion, above:

"#548243Polly
Health activist
21 Sep 2016
“There is a common tendency in medicine when faced with medically unexplained symptoms to assume that they are psychogenic in origin. This is a high-risk approach that can have disastrous consequences.”
This is a quote from Prof R Grahame, from a paper about EDS. He goes on to discuss that the symptoms of EDS/JHS were – and sometimes still are - considered to be a form of ‘illness behaviour’ He concludes by saying “To dismiss disparate symptoms as ‘illness behaviour’ is, in my view, wrong and does much disservice both to our patients and to our reputation as a profession.”

In the light of what happened to the late Dr Lisa Steen, I have to hope that the medical profession will take a long, hard look at how easy it is for patients to be inappropriately labelled as having ‘medically unexplained symptoms’ and take appropriate measure to prevent this from happening to anyone else. My area of interest is rare conditions and it is stunning to know that, according to the 2016 RDUK report, the main barriers to diagnosis are that patients are not being believed and/or are told that their symptoms are ‘psychological’. This is not OK.

Meanwhile, whilst I agree with Mrs Wenn that patients need to take action if their GPs label or diagnose them inaccurately, this can be very difficult. Doctors have been known to wriggle off the hook by saying that these diagnoses are ‘only an opinion’ and that all patients are entitled to a second opinion (see the NHS Choices information on ‘MUS/functional’ diagnoses). And far too often I hear reports back from patients who challenge these labels only to be told that they are resistant to mental health diagnoses because they are prejudiced against people with mental health conditions. This is also not OK.

Ultimately it doesn’t surprise me that people who are diagnosed as having ‘functional disorders’ cost our health service so much. It would be interesting to know how much of this cost is due to patients having to go to their GPs (often after consultations with neurologists) in an attempt to find out what ‘functional’ means. The only answer to this question that has ever made sense to me is that a ‘functional’ diagnosis ‘is a form of lazy psychological profiling.’ We deserve better."


Allowing this to go uncontested leaves anyone who accesses primary care vulnerable. It behoves each of us to stand our ground against this tsunami of denial (of both accurate diagnosis and appropriate care) by those who promote the BPS model in all its forms . This is top down implementation of junk science, which only leaves us to fight from the bottom up. We need to take a 'zero tolerance' stance. For those of us with ME part of that response is supporting OMEGA.

 

[slysaint]

https://spoonseeker.com/2016/10/27/getting-airborne/

ME Research - what is needed are a team of 'Howard Carters'.

I've been watching the series Tutankhamun on TV. Anyone not familiar with the history look on Wikipedia. He was a real expert on Egyptology and Archaeology, very hands-on, he also really understood the people. His 'peers' almost ridiculed the idea of finding a royal tomb; they had thrown money, time and manpower in the quest for decades with little success. The problem was they were looking in the wrong place.

IMO MEGA will be doing the same.

What is needed is a team who have gone thro every piece of biological research on ME thus far, who have a really good understanding of all (ie not just fatigue) ME symptoms (particularly those like intolerance to various drugs that rarely seem to get a mention) and the changing nature of the disease from onset to longterm. Real ME experts.

Research is going on in the US on what was known as Gulf War Syndrome (a lot of these vets were diagnosed with CFS).
"Roughly a quarter of the nearly 700,000 troops who deployed for the 1990-91 Iraq conflict have ill-defined chronic symptoms such as joint pain, gastrointestinal disorders, fatigue, headaches, insomnia and memory problems".

What has this got to do with ME?

"According to Baraniuk, the research could have applications for understanding non-combat-related diseases like Alzheimer's, chronic fatigue syndrome and fibromyalgia."

full article here: http://www.militarytimes.com/story/...fective-treatments-gulf-war-illness/86030830/

Meanwhile back in the UK.................(article from 2008)
http://niceguidelines.blogspot.co.uk/2008/10/professor-simon-wessely-gws-gulf-war.html
"
Professor Simon Wessely: GWS (Gulf War Syndrome) is all in the mind"

A public apology and a call to stop all GET/CBT trials would go a long way to getting any new research in the UK 'looking in the right place".