The purpose of setting up the counter-petition Opposing MEGA was to provide an option for people to reject the call for mainstream research funding (estimated £9m) posted on a public petition site on 28th September 2016 by MEGA (M.E/CFS Epidemiology and Genomics Alliance). MEGA is a project of the CFS/ME Research Collaborative (CMRC). The CMRC formed in 2013 following on from the CFS/ME ‘Expert Group’ at the Medical Research Council (MRC).
The background is that the MRC has failed a generation of patients diagnosed with Myalgic Encephalomyelitis or Chronic Fatigue Syndrome, as well as researchers wanting to investigate the underlying biology of this disease.
ME/CFS is recognised by the US FDA as ‘serious and life-threatening’, and has been classified by the World Health Organisation as a neurological disorder since 1969. The MRC preferred to fund poor quality studies such as the PACE trial, designed to provide evidence for efficacy and cost-effectiveness of the ‘bio-psycho-social’ treatments recommended by the National Institute for Health and Care Excellence (NICE).
These treatments are cognitive behaviour therapy to change unhelpful thoughts and beliefs about illness, such as fear that exercise will worsen symptoms; and graded exercise therapy to rehabilitate the patient, by gradually increasing physical exercise, avoiding the ‘boom and bust’ pattern that reinforces the patient’s misguided belief that they have a physical disease, which is made worse by exertion. This is, in fact, such a defining feature of ME/CFS that the US Institute of Medicine described it as a systemic exertion intolerance disease; in other words, the post-exertional malaise or post-exertional neuroimmune exhaustion (as described in the international expert consensus definitions of ME/CFS and ME) is not merely a belief but is very real.
The PACE trial saga has dragged on for many years, doomed from the start, wasting precious time and lives, as well as millions of pounds from the public purse. The PACE trial has so many flaws and discrepancies (the most glaring that it was possible to be disabled enough to enter the trial, get worse, yet be classed as recovered) that it is now being used in US as an example for students of how not to conduct research.
In October 2015, a 14,000 word exposé by Dr. David Tuller, academic coordinator of the concurrent masters degree program in public health and journalism at the University of California, Berkeley, was published on the Virology Blog of Professor Vincent Racaniello, titled ‘TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome’, bringing the quite incredible story of the PACE trial to the attention of a wider audience of academics and researchers, many following on with their own critiques.
PACE trial outcomes were recently reanalysed, since a tribunal upheld the decision by the Information Commissioners Office in favour of Australian patient and researcher, Alem Mathees, to allow release of raw data from the trial, but not before the responsible authority, Queen Mary University of London, had spent some £200k of public funds to try to prevent this, making themselves look ridiculous, but more seriously, raising doubts about what they may have to hide. Serious questions have now been asked in UK Parliament by MP Kelvin Hopkins, regarding investigation into whether any fraudulent activity occurred in the PACE trial; and regarding roles and policies relating to ME/CFS research at the MRC.
Back to the future of potential outcomes of the proposed MEGA research.
The M.E/.CFS Epidemiology and Genomics Alliance sounds impressive and provides a conveniently catchy acronym, ‘MEGA’. Lots of ‘ology’ and ‘omics’ smell like a breath of fresh air to a community of patients and families trapped by current thinking about their illness, thanks to the PACE trial; that it’s all about fear of activity, over-thinking normal bodily sensations as being signs of physical illness; and physical deconditioning due to lack of exercise, caused by their fears and faulty illness beliefs. The prospect of MEGA biomedical research at long last!
But wait a minute, where else have we heard that a good acronym attracts more interest in a study? Just who was responsible for the disastrous PACE trial (supposed to compare pacing with preferred ‘treatments’, and sister of the failed FINE trial), the highly controversial SMILE trial (still awaiting publication of results a year on from when promised), MAGENTA, and FITNET? Sure enough, at the bottom of the MEGA petition, we find the names Peter White (PACE) and Esther Crawley (SMILE, MAGENTA, FITNET, and other poor quality studies).
Some people ‘unsigned’ the MEGA petition when they discovered this, and following a piece by Peter White published by The Guardian on 30th September defending his position with the interesting heading ‘If my team’s research on ME is rejected, the patients will suffer‘. That was on 30th September. On 3rd October, MEGA posted an update to their petition that Peter White had retired from MEGA and will have an advisory role. Esther Crawley remains central to MEGA, along with Stephen Holgate of the MRC and Chair of the CMRC.
Stephen Holgate says he has assembled a great team of researchers in MEGA. However, it has been said quite simply that anyone unable to understand, or unwilling to accept the truth about the PACE trial, should not be involved in any way in future ME/CFS research, and certainly not be funded to do so. Thus MEGA is inevitably and irrevocably tainted, as we stated in the petition that we posted on 19th October, on the same petition site used by MEGA.
There was a spike in the number of signatures to our Opposing MEGA petition in reaction to the widespread media coverage on 1st November of the FITNET trial of psycho-behavioural therapy delivered over the internet to teenagers diagnosed with CFS/ME; exposing by their own words, that key players in the CMRC and MEGA, appear to be clueless about what constitutes good quality research. Esther Crawley said the PACE trial was a “great, great study” and of FITNET, Stephen Holgate said, “Patients deserve high quality research like this”.
MEGA closed their petition on the evening of 2nd November, possibly because of the negative response to the news of FITNET, stating they would be moving to a new website to “better manage content and improve access to information for those that don’t wish to sign up to support this study”.
By 23rd November, the Opposing MEGA petition had been open for the same number of days as MEGA, and had 369 more signatures through sheer patient/people power and without the support of the establishment organisations of the CMRC.
It is probably fair to say that MEGA or the CMRC made a pretty monumental error of judgement by deciding to seek support from the ME/CFS patient community by means of posting a petition on a public petition site. On the other hand, it has opened up some serious discussion between patients/carers who may not otherwise have been aware of all that has been going on in recent decades in the name of researching the disease from which they or their loved ones suffer. It is unwelcome news and hard to hear, but patients and carers stand to lose far more by being kept blinkered than by shining the light of truth on these matters.
On that note, you may want to read the following –
* Document produced by The Young ME Sufferers Trust afer obtaining minutes of meetings and correspondence through Freedom of Information requests. It was first published in 2014 as ‘Behind the Scenes of the CFS/ME Research Collaborative’ and is now in pdf as ‘Shining a Light on the CMRC set up‘
To shift focus on the right research, you can do no better than browse the website of the UK charity Invest in ME Research, run by volunteer patients and carers and supported by a first-class Research Advisory Board. There is so much of interest on their site (developing a UK centre of excellence, biomedical research strategy, funding PhD and medical students, international conference and collaboration with other world-leading researchers) which most people in UK rarely to get hear of as it happens independently of the CMRC.