Regular readers will know that I recently received a response from Professor Holgate to our 200-plus-signature email expressing concerns about the proposed MEGA study. “We are very appreciative of the enthusiasm being shown to pursue an exciting ‘omics-based research project in the field of M.E…” he said, with no mention of the various pressing concerns we raised in our email. You can read the whole of his message in this previous post.
It is a strange response indeed. It is like the shipping line which ran the Titanic writing to bereaved relatives to thank them for their interest in the general principle of oceanic travel. To carry the metaphor further, Professor Holgate is pleased to be in touch with us, but changes the subject whenever we mention icebergs.
I have now received a further response (addressing my response to his response), this one saying so little that I won’t bother printing it here, but once again referring us to the brand new MEGA website, which is indeed up and running at last.
If you’ve seen it, you were probably less than impressed. At first sight, it looks pretty much like the last one, though with the now defunct petition and the opportunity to leave comments both removed.
One thing I did pick up from Holgate’s latest letter, however, is that you can in fact leave comments. You go to the ‘contact us’ page and write in the box. If you leave a comment, it isn’t clear what happens to it, but if you leave a question and it’s one that they feel like answering, they will stick it on the bottom of the question and answer page the next time they update it. It’s not exactly the level of interaction we are used to these days but I guess it’s better than nothing so it’s a pity they don’t explain it properly on the website.
The Q&A section has indeed already been expanded, and down at the bottom there are some questions which seem to have genuinely come from patients. Like this one for instance: Will you define the sample of patients and tests before the study starts or wait till data starts rolling in and then cherry pick the patients and data to best support your hypothesis?
I can’t see Professor Holgate penning that one. I think the world-weary cynicism reveals it as one from a patient or carer. I’m pleased to say that the answer given is reassuring enough: Once we have created the Bioresource, we will apply for funding to do the research. We agree that it is very important that analyses are defined before it is done. It will be a requirement that all scientists who use the MEGA Bioresource will submit an analysis plan prior to using the data or samples.
Here’s another question on the page: Will you ensure that only people with post-exertional malaise are included to ensure this is not a study about people who have unexplained fatigue, many of whom might have had an incorrect diagnosis of ME/CFS? The answer: We agree it is very important that we check that the diagnosis of ME/CFS is correct and will check the diagnosis at several stages during recruitment.
They seem to have side-stepped the mention of PEM there (so maybe Holgate wrote that one – icebergs again…) But no need for dismay. Higher up on the page is this: all patients will need to have post-exertional malaise to be present. That wasn’t on the previous site but it’s definitely on this one. I’ve taken a screenshot as evidence in case they change their minds. It’s heartening to see it there. The patient advisory group needs to ensure it’s enforced.
So it’s worth taking a look through those Q&As rather than assuming you’ve seen it all before. You might spot something I’ve missed. There’s also a ‘why we need MEGA’ overview of the project by Professor Holgate, which looks to be an expansion on his previous piece about the need for a broad definition. Plus, of course, there’s the ‘get involved’ section with instructions for how to apply to be on the adult patient advisory group.
The original deadline for this was six days away , clearly not long enough considering there’s an important decision to be made and a form to fill in and they’re dealing with people who are either sick or else juggling with their caring duties. Under protest, it has been extended by an extra week. The deadline is now 13th Dec at 9am: about the least they could do really. Six days was patently outrageous.
Which leaves those of us who think we are well enough and interested enough in this whole business in a bit of a quandary. Do we apply to join the advisory group or leave well alone?
Well, I signed the OMEGA petition in good faith and encouraged others to do the same, and with a) the patients coming from the clinics and b) the involvement of Professor Crawley and – especially – c) the juxtaposition of a and b, I’d really rather this thing wasn’t going ahead.
But if we can’t stop it, and that seems unlikely, then it seems to me that the more of us who understand the importance of pushing to get this thing done properly get on the advisory group, the better. Otherwise other people who may be less inclined – or less aware of the need – to stand up to Esther Crawley may end up on it instead.
So my present line of thinking is that I’m going to send in my application form for the group. Your views on this questionable course of action are welcome.
Before I move on, it’s worth observing that volunteers are not being sought to serve on the patient advisory group for the children’s part of the trial. This is because such a group is already established and the word is it’s the same group that is already serving on the FITNET trial. So this is the group that thought it was hunky dory for Professor Crawley to say she’s using the NICE diagnostic criteria when she’s not (having surreptitiously removed the necessity for post exertional malaise to be present) and which also thought it was fine for children in the activity management ‘control’ group to be encouraged to increase their activity by 10 to 20% per week up to 8 hours a day.
So it’s a sobering thought that unless we can persuade the powers that be that a new children’s PAG is needed (and chosen by someone other than Professor Crawley), we’ll have no power to ensure that the children’s trial is run properly, however many informed adults are willing to serve.
This coming Wednesday (7th Dec), Professor Holgate has accepted an invitation from the Countess of Mar to talk about MEGA to the Forward ME Group at the House of Lords. Maybe he will be more inclined to give answers to the Countess of Mar than he has been to us. I’ve sent her a copy of that email of ours and mentioned a few other points. If there’s anything else you think should be brought to her attention, she can be contacted via Forward ME. (I raised with her the issue of ‘recycling’ the children’s PAG but if anyone else would like to mention this, I think it would be no bad thing as I fear it might be overlooked among so many other concerns.)
Someone who knows him well has just described Professor Holgate as ‘a very kind and caring doctor who genuinely wants to get to the bottom of what is causing ME/CFS’ and that may well be true. It may also be that he deserves much more credit from us for bringing together such an impressive team of researchers to work on MEGA. But the trouble is he refuses to see what is right in front of his face, even when we point it out to him. His heart may be in the right place – and I personally have no evidence either way – but if so, then he makes the mistake of assuming the same is true of all his colleagues, even those of the BPS persuasion. There is a role for those who are affable hosts but also for those who take resolute action when it is needed and are prepared to tell their colleagues when they’re out of order. Part of the ‘job specification’ for the patient advisory group reads ‘to have a keen interest in critical evaluation and be able to look at a situation as objectively as possible’ and ‘be willing to challenge’. To do this, you have to take off your rose-tinted spectacles first – and it seems wrong that this role has to be left to the patients.
Update: When I wrote this post, I hadn’t noticed the punishing Christmas schedule which the patient group will be required to negotiate. Please take a look at this follow-up post.
spoonseekerdotcom 
Thanks for your continuing excellent work.
I agree if it’s going ahead anyway some people with the strength and knowledge to challenge should apply.
I have been trying to track down stuff about how MEGA came about, and found this from Stephen Holgate’s address to the September 2015 CMRC conference:
…the IOM definition is important because it is inclusive: it catches the whole population. Rather than preconceived (and potentially inaccurate) descriptors and subdivisions being imposed upon this illness, this opened the way for stratifications based on cutting edge science.’
From CMRC board minutes November 2015:
SH identified the need to have a broader more inclusive definition to enable the development of disease clusters will be an important consideration.’
So it looks like between September 2015 and November 2015 he rowed back from the importance of using the IOM definition to ‘a broader more inclusive definition’. It would be great if someone would ask him to clarify this and who persuaded him to change it, especially since now they seem to be talking about the NICE guideline definition.
For clarity, this is the IOM definition – all 4 items must be present:
1. a substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest;
2. postexertional malaise (often described by patients as a “crash” or “collapse” after even minor physical or mental exertion);
3. unrefreshing sleep; and
4. cognitive impairment and/or orthostatic intolerance.
Another question I’d like asked is what happened to their plan to apply to the Wellcome fund for collaboratives in September 2016, and how did it suddenly transmogrify into a last minute application to the fund for setting up resources such as biobanks etc in January 2017?
And how come, since the need for a patient group was mentioned in May 2016, it’s now being set up in such a rush.
And what happened to the plan 3 years ago to set up a CMRC website? Is there one? I don’t mean the hastily cobbled together MEGA site.
Sorry, this is probably the wrong place to ask such things. It all sees so shambolic. I can’t even find the minutes to most of their meetings.
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I think that we really need people on the patient advisory group who understand the wider issues and who can challenge. Thanks from those of us who are unable to. Hope your appplication is successful.
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One observation with respect to PEM. Phil Hammond quoted PEM ‘up to’ 24 hours or longer , although he later amended that statement in a further statement.
However, one has to wonder how PEM, if included, would be interpreted. PEM that’s delayed by at least 24 hours is a cardinal symptom of CFS/ME, yet it seems some might be defining it as fatigue immediately after exertion, which is simply general fatigue and not necessarily CFS/ME.
BTW,great work. Thanks.
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Have sent Countess of Mar my 2008 transcript of what SH stated to patients, the charities and medical colleagues in public……..surely he should be held to that?
It was a personal commitment and one representing the MRC…..basically , “Don’t worry, I will sort it!”
Yer, right on!
He might be a “nice man”, but a NICE man is as useful atm as a chocolate teapot.
I hope Margaret Mar asks him why the Kerr gene expression research went pear shape?
Could it be that OP’s were implicated, also implicated in Gulf War illness?…….
..SH doesn’t want to confront Wessley it appears…
This all has a very nasty smell especially with Georgina Downs JR victory against the Government in 2008 due to failure to protect human health from pesticides. Georgina also attended the Holgate hosted 2008 Southampton Conference.
I smell a big fat Government rat and interference I am afraid.🐀
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I quite agree that competency in a job is more important than personality or well-meaning aims, and as you say, it may well be true that Professor Holgate as ‘a very kind and caring doctor who genuinely wants to get to the bottom of what is causing ME/CFS’, but doctors are people and people are complex beings and behave or respond in different ways on different occasions towards different people, and this affable public image doesn’t square with two examples with direct relevance to CMRC/MEGA, which are 1) the disregard he showed for the trustees of the charity Invest in ME Research by contacting their ‘Scientific Advisory Board’ directly, in other words bypassing the patients/parents running the charity, regarding the Opposing MEGA petition; 2) the way he treated a junior researcher, Dr. Keith Geraghty – https://opposingmega.wordpress.com/2016/11/19/dr-keith-geraghty-comments-on-opposing-mega/
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We have another parallel here with what was issued from “Southampton” on the research and health impacts on human health from particulates (mainly from diesel) 1990s up to 2005 when they changed their mind and reversed their advice re small particulates.
Pre 2005 they suggested small particulates were not the most harmful and that the” larger” were the most damaging. Wind on 10 years to the VW fiasco..
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First of all, folks need to keep in mind we are talking about an *advisory* committee, not a *steering” committee that can actually say “NO” to anything MEGA has already decided. The PAG will be nothing more than a rubber stamp. The documents they receive will be vague materials more suitable for marketing than managing a complex project.
In the unlikely event that any prominent critics are actually appointed to the panel, they will be presented as evidence that MEGA is “listening to the patients” while working to undermine their critics, in the same way that in the US, demonstrators are presented as evidence of “free speech” while being confined to a state-approved protest pen.
I have seen this movie so many times that the script writes itself. The only trial Crawley and gang should be a part of is a criminal trial.
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Many thanks for all these comments. Sorry I don’t have the energy at present to respond to everyone. Just to take up a few of the points: Andy raises the issue of what PEM actually entails, which is something not often addressed as far as I know. Personally I find that the worsening of symptoms after exertion sometimes comes on immediately and sometimes a day or two later and sometimes both. My illness was sudden onset after Epstein Barr so I don’t think there’s much doubt I have genuine ME, so I’m not sure the delay has to be obligatory. MEpedia says: “the onset of PEM can be delayed 24-72 hours”, the important word here being “can”. The ME Association says: “The predominant symptom of ME/CFS is usually severe fatigue and malaise following mental or physical activity. The full extent of this exhaustion often becomes apparent only 24 to 48 hours after the activity (assuming, of course, the person was not already in a ‘recovery period’ from a previous activity).” This time the word “often” denotes the uncertainty. But it’s interesting they recognise that things may be different if you were already recovering from previous exertion, hinting at what an intricate task it can be to try and manage this condition. To summarise, I personally suspect there’s no hard and fast rule about this. All is complexity.
As for Holgate, I suspect his amiability is that of the old boy (and in this case also girl) club, friendly with those who are members but rather suspicious of – and tending to be patronising towards – those outside the castle walls. So if he wants to ascertain the mood of patients he will certainly ask another doctor rather than the patients themselves and he will be suspicious of a newcomer such as Keith Geraghty, referring him to good old Esther for character reference first. And needless to say it’s this same perspective which allows the BPS school to think they can carry on as if PACE is sacrosanct and nothing has changed. The people who have exposed it are not in the club.
I had another point I wanted to mention. Maybe tomorrow…
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Thanks. Yes, I believe you should apply to join the PAG. If MEGA is going to happen we need the right people involved to try to steer it in the right direction. Better for people to join and resign in protest If patients’ concerns are ignored than to stand on the sidelines. It is heartening to read how much agreement there is among patients expressing views about MEGA online. These views must be represented by knowledgeable advocates on the PAG.
Meanwhile I am going to forward the comments I submitted to MEGA via their new website to the Countess of Marr: https://mobile.twitter.com/RobertHMcMullen/status/805798903677419520
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Belated thanks for your comment, Robert. For better or worse, I put in my application so we shall see. Charles Shepherd has just announced on Phoenix Rising that 32 applications have been received so far and the standard is high, so let’s hope that bodes well. I kind of hope they can put together a good group without calling on me! Tbh there’s things I’d rather do with my limited time and energy but having taken such an interest in the thing, it would have seemed like a cop out not to apply. (I should add that I’m only applying that judgement to myself, not to anyone else. I fully accept that there are many totally valid reasons for not applying. But in my case I felt that it would be wrong to carry on blogging about the damn thing if I’d passed up the chance to get involved.)
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