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.