Some brief comments on the OMEGA petition from Dr Charles Shepherd:
As I have already made clear on numerous occasions:
1 Although I am a member of the Board of the CMRC (CFS/ME Research Collaborative) I am not part of the MEGA (ME/CFS Epidemiology and Genomics Alliance) study planning group
2 The protocol (i.e. design of the study) is still being discussed and developed - especially in relation to patient selection, how people with severe ME/CFS will be included, the use of samples from the ME Biobank, and the people who will be actively involved in carrying out the work
3 The MEA supports the AIMS of the MEGA research study - which is to gather comprehensive information using a variety of new biomedical technologies (e.g. epigenetics, metabolomics, proteomics etc) to see if there are abnormalities or biomarkers which are present (and not present) in the numerous clinical sub-groups of people who come under the ME/CFS and undiagnosed chronic fatigue umbrellas. This could obviously be of significant benefit when it comes to separating people who have ME or ME/CFS from those with undiagnosed chronic fatigue. The findings could also lead onto assessing new forms of treatment which are based on these findings
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
5 Just like the patient community, The MEA is very keen to see blood samples from the ME Biobank - where we have just got on with research and collected blood samples from over 500 people included in the MEGA study. This figure translates into over 30,000 blood sample aliquots available for research purposes. In addition to the ME/CFS samples, the ME Biobank blood sample collection in the UCL Biobank at the Royal Free Hospital in London also includes a cohort with severe ME/CFS, healthy controls, and samples from people with multiple sclerosis
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
And having played a role in organising the MEA petition that was opposed to spending money of the PACE trial, I can understand why the patient community may wish to organise a petition against a research study that they do not support
However, it is disingenuous to imply that the group of biomedical research scientists listed below, who form the core planning group, were involved in the PACE trial, or are supporters of the biopsychosocial model of causation and management of ME/CFS. The MEGA study is NOT a treatment trial and it does NOT link to the PACE trial.
As already noted, the MEGA study is still in the early planning stages - so discussions are taking place about all aspects of the study, including patient selection procedures and the inclusion of a severe ME/CFS cohort
The concerns of the patient community are being taken note of at the highest level at the CMRC
So I would question whether it is really sensible for the patient community to be producing a petition to try and stop the study in its tracks at this stage in the development process
There is also a real risk here in that a significant number of the various -omic research scientists involved, most of whom have international reputations in regard to their areas of expertise and in many cases are new to ME/CFS research, and have expressed a willingness to take part in this study, will interpret this very negative patient reaction as indicating that the patients they want to help do not want to see them involved in ME/CFS research
These scientists have plenty of other diseases they could easily go off and research - where their input would be widely welcomed by the patients involved
If we now lose their input at this point as a result of this petition, I think it will be very difficult to find others of equal stature to replace them
And so a study which aims to find out if there are objective abnormalities or biomarkers that could help to dismantle the current NICE guideline 'one size fits all' approach to causation and management of ME/CFS could be lost for a considerable period of time
My final and key point goes back to the fact that the MEGA study is still in the process of being discussed and prepared
If the final proposal that is submitted for funding is not acceptable to the MEA, especially in relation to patient selection, then The MEA will NOT endorse it
So now is not the time to try and kill the MEGA study off for good............
Further information relating to MEGA study:
- Part of the distinguished panel of research 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) and Prof David Ford (Swansea)
* Infection – Prof Paul Moss (Birmingham)
* Sleep – Prof Jim Horne (Loughborough)
* Pain – Prof Maria Fitzgerald (UCL)
* Prof Julia Newton (Newcastle)
"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.
Dr Charles Shepherd
Hon Medical Adviser, MEA
. I can't speak for him, but I think it's a safe bet, that as with the other omicists, Ponting wouldn't be investing his time in this (check his publication record, he's a busy guy!) if he thought that PACE and the BPS model were the answer to mecfs.
