We vote 'no confidence' in MEGA research for M.E.
A UK medical research group called MEGA (M.E./CFS Epidemiology and Genomics Alliance) has set up a petition for public support to help them obtain millions of pounds (estimated minimum £9m) from research funding bodies for a prospective study of a neurological disorder known for research purposes as ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome).
The professional ethics of petitioning the public for support in order to obtain research funds and petitioning support of a vulnerable community of patients/carers is questionable.
The MEGA petition includes words such as 'biological' 'biomedical' 'big data' 'potentially game-changing' - clickbait for patients/carers desperate for definitive diagnostic tests and medical treatments, yet updates show how little thought and planning has been given by the research team to their own proposal. They had not even thought of including the 25% most severely ill patient cohort in their proposed 12,000 participants.
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.
Thus in signing this petition we reject calls from the ME/CFS Epidemiology and Genomics Alliance to create any proposal for a ‘big data’ study, or any study of any description, regarding it as inevitably and irrevocably tainted.
No more wasting time, money, lives – not in our name.
There are genuine opportunities for UK biomedical researchers to get involved in ME/CFS research and to really make a difference to millions of people's lives. It is not a case of 'MEGA or nothing'.
A site has been set up for further information -
ICO Tribunal Decision published August 2016 -
Please also updates below.
Thanks to all for your support.
- Mainstream Research Funders
To Mainstream Research Funders,
FAO: All persons with responsibility for research grant applications
CC: Any persons with an interest in the above
NB: This is a serious matter of public interest so please acknowledge receipt of this letter and note that correspondence will be in the public domain
To whom it may concern,
This letter is to inform you that a majority of people reject calls by the M.E./CFS Epidemiology and Genomics Alliance (a project of the UK CFS/ME Research Collaborative) to support their forthcoming submissions for funding for their research proposals.
MEGA created a petition addressed to 'mainstream research funders' on a public petition site and this petition was publicised on internet sites of CMRC member charities representing ME patients, from 28th September 2016.
A number of valid concerns about this call for funding were not allayed by subsequent correspondence with members of the board of CMRC. Thus a counter-petition was posted on 19th October on the same petition site as used by MEGA to provide an option to register rejection of calls for mainstream funding of their study proposals.
Supporters of the counter-petition were described by a charity representative member of the CMRC Board as 'a vocal minority' and the Chairman of the board wrote that they were 'baffled' by opposition to the MEGA proposals, in spite of having read carefully considered and in some cases, quite detailed explanations of the various concerns.
The 'MEGA' petition was open for 35 days. It closed on the evening of 2nd November and has 2,542 signatures. The counter-petition 'Opposing MEGA' had 2,912 signatures at 35 days (currently over 3,000). This shows that more people rejected the call by MEGA for mainstream research funding than supported it within the same amount of time.
It is understood that the MEGA petition was a means to demonstrate the weight of support from patients for forthcoming grant applications. In that respect it has not succeeded as it is now a matter of public record that the majority of patients have cast a vote of no confidence in MEGA and reject calls for mainstream research funding applications by an alliance formed by the CMRC.
It will not suffice for MEGA or CMRC to reassure research funders that patients are represented on their steering and monitoring committees and advisory groups or that patient concerns will be taken on board. Such measures have not served the best interests of ME/CFS patients over decades past and there is no reason to suppose there will be any change in this position going forward. Indeed great harm has been caused to many ME/CFS patients with the same establishment charities involved as are currently represented in the CMRC.
In addition we are informed that the children and young persons representation will be taken from an existing group working within the University of Bristol. We must assume that this group of young people will already be involved in other trials being conducted by MEGA applicant, Professor Esther Crawley - MAGENTA and FITNET-NHS - both of which are already embroiled in controversy. These young people will, therefore, be already subjected to bias and influence.
Dr. David Tuller, academic coordinator of the concurrent masters degree program in public health and journalism at the University of California, Berkeley, explained:
"Dr. Crawley is a professor of child health at the University of Bristol. She is also currently recruiting for the MAGENTA study of graded exercise therapy for children with the illness. She is a lead player in the U.K. CFS/ME Research Collaborative, an umbrella organization that is sponsoring an ambitious Big Data effort called MEGA, now in the planning stages. While patients and advocates are desperate for the kind of top-notch biomedical and genetic research being proposed, many oppose MEGA precisely because of the involvement of Dr. Crawley and Peter White, the lead PACE investigator. (Dr. White is reportedly no longer involved in MEGA; Dr. Crawley still definitely is.)"
The PACE trial has been debunked internationally by leading clinicians and scientists, and 42 experts signed an open letter to The Lancet, condemning its egregious flaws and noting that they “have no place in published research.” The PACE trial has even been presented as a case study of bad science in graduate epidemiology seminars and at major scientific gatherings. MAGENTA relies on the PACE trial as evidence of efficacy of graded exercise therapy in adults. The PACE trial results have been shown to have been grossly exaggerated to claim positive effects of psycho-behavioural therapies, and in any case, had shown null effect at long-term follow-up. FITNET-NHS relies on a Dutch study, with methodologcal flaws, and which showed null effect of the treatment trial at long-term follow-up. As the MEGA team have consistently refused to answer all questions about PACE, and are even relying on it for funding of current treatment trials, we submit that the MEGA applicants are attempting to build a research project on crumbling foundations and should receive no further funding under any guise.
We would draw your attention to a number of parliamentary questions raised by Kelvin Hopkins MP regarding matters of conduct, policy, and funding, as these relate to individuals and organisations, including patient charities, involved in the MEGA proposal and on the board of the CMRC, and reflect the central concerns raised in the Opposing MEGA petition and the conclusion that we have no confidence in MEGA.
It is imperative that research funders are aware of the majority view in response to the request by MEGA for support of their proposals and the legitimate concerns behind this majority view. This is, of course, particularly important where those funds are from the public purse and when better value for money can be gleaned by using existing resources.
As Prof Jonathan Edwards, Emeritus Professor of Connective Tissue Medicine, stated on the Phoenix Rising Forum:
"Of course it would be nice to have a big study of lots of things in lots of patients but it needs to be done carefully and it will cost a vast amount of money to do that. I think it likely that the money would be better spent in other ways. We already have a Biobank resource and a method for recruiting cohorts - which could be improved but is a good start. I strongly suspect that several metabolomic and genetic and other projects are already being set up with reasonable sized samples elsewhere in the UK".
The international scientific and clinical community is on the verge of establishing biomarkers for accurate diagnosis of this complex disease, known for research purposes as ME/CFS, and it would be foolhardy to fund a fishing expedition at this stage. However, we must emphasise that our petition is not primarily concerned with the details of the protocol, but rather with the insurmountable and serious matters of research conduct and integrity.
Patients and professionals alike were misled over the PACE trial from its inception to the present day. Children are among the patients suffering daily from the consequences. We cannot afford as a civilised society to repeat nor perpetuate this mistake.
Thus, we submit this letter and Opposing MEGA petition, along with its comments, as an outright rejection of calls by CMRC/MEGA for mainstream research funding and request that you ensure this letter and content is brought to the attention of all personnel in your organisation with responsibility for research funding applications.
We are willing to provide you with further information upon request. We would strongly recommend that you take note of the comments on the petition, the various updates posted and the Opposing Mega website
on behalf of
Organisers and signatories to the Opposing MEGA counter-petition -https://www.change.org/p/opposing-mega-a-vote-of-no-confidence-in-mega-research-for-me-cfs
Opposing MEGA rejects this petition by MEGA to mainstream research funders - https://www.change.org/p/support-this-huge-biomedical-m-e-cfs-study-and-its-application-to-major-uk-research-funders
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