Dear Professor Holgate, 23rd November 2016
Re the CMRC and MEGA:
You will by now be aware of the concerns of some ME sufferers and their families about the CMRC and the proposed MEGA study. I will not rehearse all the arguments again.
This is not a negative or orchestrated campaign, rather it is a lot of isolated, sick people sharing their concern that scarce research funding be put to the best possible use.
I have been an ME sufferer for 27 years, ill-health retired from Maths teaching for 13 years and housebound for the last 8 years. I am also the mother of another long term housebound sufferer. I am am desperate for high quality biomedical research into ME.
I have some specific questions that I would be grateful if you would answer. You are busy man, so I will ask my questions in a way that only requires YES/NO answers, though of course you may choose to elaborate or demur. I suggest to save time you could simply copy and paste my questions into your reply with your answers added after each question.
I intend to make this letter public along with any response I receive from you. Although I am the sole signatory, there are many ME sufferers awaiting your answers. I trust, as a doctor who cares for patients, and a researcher with a stellar record, you would wish to uphold your good reputation by taking a few minutes to answer our specific questions.
I am aware that we are likely to disagree on some points, and expect some 'NO' answers. I would prefer straightforward honest disagreement to equivocation.
Part I: The CMRC:
The CMRC has lost the trust of many ME sufferers for reasons that have been spelled out to you in other correspondence. In order to repair that trust:
1. Will you make public, on behalf of yourself and the CMRC, your unequivocal agreement with the following points?
2. Will you make public your unequivocal withdrawal of your recent personal public support for Professor Crawley’s FITNET trial, which you now understand not to be justified by any valid research evidence, whose claims of success have been wildly exaggerated, not least in an overblown and biased media campaign, which wrongly conflated ‘fatigue’ and ME/CFS, and whose treatment methods based on increasing activity can be harmful to patients with ME?
For evidence see the recent article:
http://www.virology.ws/2016/11/21/trial-by-error-continued-the-new-fitnet-trial-for-kids/
3. The Science Media Centre:
a) Will the CMRC cease to make use of, or offer observer status to the SMC which has a long history of bias towards the BPS model and its proponents, of exaggerated reports of treatment efficacy, of denigrating ME patients as malingerers and troublemakers, and of downplaying or ignoring biomedical ME research?
b) Will you demonstrate this distancing from the SMC by communicating your agreement with points 1 and 2 above with a press release issued directly to the major British media outlets and copied to ME patient organisations for publication, written without SMC influence?
4. Will you clarify the remit of the CMRC? Is it:
Part II The MEGA project.
5. Will you, in order to restore patient trust and ensure high quality, unbiased science, act to remove Professor Crawley and all proponents of the failed BPS model of ME/CFS from any involvement with MEGA, whether direct or advisory?
6. Sample definition and design:
a) Will you ensure that MEGA is designed to study ME/CFS as defined by internationally recognised biomedical research criteria including post exertional malaise (PEM) as an essential defining symptom? Will you reject the use of the Oxford or NICE criteria?
b) Will you ensure a representative sample stratified by age, duration of illness, severity of illness and gender,
Or c) If b) is not possible, will you skew the sample towards the long term and more severe end since these are the most likely have true ME and to provide the strongest biochemical signals?
d) Will you use population based sampling, using GP practices, rather that the skewed subpopulation who attend fatigue clinics?
7.
a) Will you ensure that all MEGA biomedical studies are done in co-operation with, and informed by, internationally recognised experts in ME biomedical research so limited funding can be most productively focused?
b) Will you consult with international experts on which ME/CFS questionnaire data should be collected to help elicit subcategories of ME sufferers and enable international pooling of results?
c) Will you reject questionnaires designed, chosen or used by BPS proponents that enable p-hacking to find spurious psychosocial factors which can be misused to ‘explain’ aetiology or prognosis (a common and damaging practice)?
8. Will you base the study entirely on the already existing ME biobank that patients have confidence is properly set up with well diagnosed patients, expanding it as funding allows and making use of their expertise in sample selection?
9. Sample size and priorities.
10. Will you inform yourself and others of your team about current biomedical research in ME by reading reports of all papers presented at the recent International CFS/ME conference in the USA, recent IiME conferences and other published biomedical papers?
11. Open data:
a) Will you ensure that all studies using MEGA data are published in open access journals concurrently with making openly available the raw anonymised data on which they are based? And that:
b) after a reasonable time for such studies to be written up and published, all anonymised raw data, whether included in published studies or not, will be made openly available?
12. You will be aware that many ME sufferers do not support the patient organisations AfME and AYME. Will you ensure broader patient representation on a patient advisory panel by including representatives of, for example, MEA, TYMES and IiME and other interested volunteers including housebound sufferers consulted on-line, including some who have expressed reservations about aspects of MEGA, and including some ME sufferers or family members with scientific, medical, statistical and/or other research knowledge. Will that patient panel have a genuine input in the design of the study?
13. Will you reveal the details of the funding bodies to whom a copy of the MEGA petition has been submitted so that they can be given a balanced view by also receiving a copy of the OMEGA petition which has more signatories?
Thank you for your time and attention. I do hope you feel able to clarify the points I have raised by answering my questions. Please excuse any errors, this has been written over many hours and several days at cost to my health.
If you choose to share this e-mail with anyone else or communicate with others about it, I would assume you would do me the courtesy of informing me and copying me into any correspondence.
You may share my name, but please do not share my private e-mail address.
Yours sincerely,
Re the CMRC and MEGA:
You will by now be aware of the concerns of some ME sufferers and their families about the CMRC and the proposed MEGA study. I will not rehearse all the arguments again.
This is not a negative or orchestrated campaign, rather it is a lot of isolated, sick people sharing their concern that scarce research funding be put to the best possible use.
I have been an ME sufferer for 27 years, ill-health retired from Maths teaching for 13 years and housebound for the last 8 years. I am also the mother of another long term housebound sufferer. I am am desperate for high quality biomedical research into ME.
I have some specific questions that I would be grateful if you would answer. You are busy man, so I will ask my questions in a way that only requires YES/NO answers, though of course you may choose to elaborate or demur. I suggest to save time you could simply copy and paste my questions into your reply with your answers added after each question.
I intend to make this letter public along with any response I receive from you. Although I am the sole signatory, there are many ME sufferers awaiting your answers. I trust, as a doctor who cares for patients, and a researcher with a stellar record, you would wish to uphold your good reputation by taking a few minutes to answer our specific questions.
I am aware that we are likely to disagree on some points, and expect some 'NO' answers. I would prefer straightforward honest disagreement to equivocation.
Part I: The CMRC:
The CMRC has lost the trust of many ME sufferers for reasons that have been spelled out to you in other correspondence. In order to repair that trust:
1. Will you make public, on behalf of yourself and the CMRC, your unequivocal agreement with the following points?
- the biopsychosocial (BPS) model for ME/CFS is not evidence-based or valid.
- ME/CFS is a serious debilitating physical illness, and this statement is based on sound international biomedical research evidence.
- Evidence used to support the BPS model is flawed and all research trials of treatment methods based on CBT aimed at changing ‘false illness beliefs’ and graded exercise to overcome ‘deconditioning’, demonstrate that these methods do not lead to recovery or clinically significant long term improvement, and are often harmful. PACE and FINE are null trials.
- ME/CFS should not be conflated with or defined by the symptom ‘chronic fatigue’. Research into ME/CFS will only be supported by the CMRC if it uses internationally recognised biomedical research definitions with post exertional malaise (PEM) as the cardinal symptom (not post exertional ‘stress’).
- No further research funding should be spent on trials of CBT or GET or similar, and such trials, including MAGENTA and FITNET, will not be supported in any way by the CMRC.
- The CMRC will no longer seek to ‘balance’ supporters of psychosocial and biomedical models of ME/CFS in its membership. This includes removing members who pay lip service to biological aetiology while continuing to support, research or practice psychological or activity/exercise based treatments.
2. Will you make public your unequivocal withdrawal of your recent personal public support for Professor Crawley’s FITNET trial, which you now understand not to be justified by any valid research evidence, whose claims of success have been wildly exaggerated, not least in an overblown and biased media campaign, which wrongly conflated ‘fatigue’ and ME/CFS, and whose treatment methods based on increasing activity can be harmful to patients with ME?
For evidence see the recent article:
http://www.virology.ws/2016/11/21/trial-by-error-continued-the-new-fitnet-trial-for-kids/
3. The Science Media Centre:
a) Will the CMRC cease to make use of, or offer observer status to the SMC which has a long history of bias towards the BPS model and its proponents, of exaggerated reports of treatment efficacy, of denigrating ME patients as malingerers and troublemakers, and of downplaying or ignoring biomedical ME research?
b) Will you demonstrate this distancing from the SMC by communicating your agreement with points 1 and 2 above with a press release issued directly to the major British media outlets and copied to ME patient organisations for publication, written without SMC influence?
4. Will you clarify the remit of the CMRC? Is it:
- an advisory group to the Medical Research Council,
- a professional body for ME/CFS researchers,
- a body designed to promote and/or commission CFS/ME research,
- a research group setting up a clinical trial and applying for funding?
Part II The MEGA project.
5. Will you, in order to restore patient trust and ensure high quality, unbiased science, act to remove Professor Crawley and all proponents of the failed BPS model of ME/CFS from any involvement with MEGA, whether direct or advisory?
6. Sample definition and design:
a) Will you ensure that MEGA is designed to study ME/CFS as defined by internationally recognised biomedical research criteria including post exertional malaise (PEM) as an essential defining symptom? Will you reject the use of the Oxford or NICE criteria?
b) Will you ensure a representative sample stratified by age, duration of illness, severity of illness and gender,
Or c) If b) is not possible, will you skew the sample towards the long term and more severe end since these are the most likely have true ME and to provide the strongest biochemical signals?
d) Will you use population based sampling, using GP practices, rather that the skewed subpopulation who attend fatigue clinics?
7.
a) Will you ensure that all MEGA biomedical studies are done in co-operation with, and informed by, internationally recognised experts in ME biomedical research so limited funding can be most productively focused?
b) Will you consult with international experts on which ME/CFS questionnaire data should be collected to help elicit subcategories of ME sufferers and enable international pooling of results?
c) Will you reject questionnaires designed, chosen or used by BPS proponents that enable p-hacking to find spurious psychosocial factors which can be misused to ‘explain’ aetiology or prognosis (a common and damaging practice)?
8. Will you base the study entirely on the already existing ME biobank that patients have confidence is properly set up with well diagnosed patients, expanding it as funding allows and making use of their expertise in sample selection?
9. Sample size and priorities.
- Will you prioritise starting the studies requiring smaller samples, such as metabolomics, before the large scale data collection is completed?
- For a genomic study which needs a larger sample, will you act in concert with international researchers, pooling data into a single database to avoid the need for so many thousands of British patients, thus avoiding pointless delay, cost and duplication?
10. Will you inform yourself and others of your team about current biomedical research in ME by reading reports of all papers presented at the recent International CFS/ME conference in the USA, recent IiME conferences and other published biomedical papers?
11. Open data:
a) Will you ensure that all studies using MEGA data are published in open access journals concurrently with making openly available the raw anonymised data on which they are based? And that:
b) after a reasonable time for such studies to be written up and published, all anonymised raw data, whether included in published studies or not, will be made openly available?
12. You will be aware that many ME sufferers do not support the patient organisations AfME and AYME. Will you ensure broader patient representation on a patient advisory panel by including representatives of, for example, MEA, TYMES and IiME and other interested volunteers including housebound sufferers consulted on-line, including some who have expressed reservations about aspects of MEGA, and including some ME sufferers or family members with scientific, medical, statistical and/or other research knowledge. Will that patient panel have a genuine input in the design of the study?
13. Will you reveal the details of the funding bodies to whom a copy of the MEGA petition has been submitted so that they can be given a balanced view by also receiving a copy of the OMEGA petition which has more signatories?
Thank you for your time and attention. I do hope you feel able to clarify the points I have raised by answering my questions. Please excuse any errors, this has been written over many hours and several days at cost to my health.
If you choose to share this e-mail with anyone else or communicate with others about it, I would assume you would do me the courtesy of informing me and copying me into any correspondence.
You may share my name, but please do not share my private e-mail address.
Yours sincerely,
