Hillsborough Law – Shifting the Balance in Favour of Truth

Spotlight on GETSET Julie

Do GET Yourself

GETSET, the latest paper on graded exercise therapy by lead PACE investigator Peter White (et al), provides an excellent opportunity to probe into the nitty gritty of such a trial. The study required patients to administer their own GET so some of the details previously hidden by smoke and mirrors are laid bare in the explanatory booklet which served as the patients’ bible during the study.

Here are some quotes from the booklet (in blue) followed by my comments:

A GET programme will help you gradually improve your ability to undertake some of the physical activities that you have been unable to do since becoming unwell.’

The word ‘will’ seems optimistic here if we’re talking about ME. Though what illness are we talking about, I wonder? This guide refers to CFS/ME but the GETSET paper only mentions CFS. They need to be more specific about what they’re talking about.

However, a self-help guide such as this has not been officially tested so it is important that you check first with your GP or hospital specialist that a GET schedule is suitable for you. You should also continue to consult them regularly while undertaking your GET programme.’

Maybe they’re already wondering if that optimism of theirs was misplaced. This translates as ‘This therapy is totally, totally safe but make sure you tell some other doctors what you’re doing so we can blame it on them if it goes wrong.”

There may be a number of reasons why exercise did not work for you before. You may have started at too high a level of physical exercise, or increased the amount you did too quickly. You may have used an exercise that was too challenging for you now such as jogging, which you could do perfectly well before you became ill with CFS/ME.’

They seem to have forgotten the alternative explanation that it didn’t work because you may have ongoing pathology in your body – as illustrated by some of the biomedical research that got done with the small amount of money that wasn’t all wasted on nonsense like this.

‘The 2007 National Institute for Clinical Excellence (NICE) guidelines for the management of CFS/ME recommend GET as one of the most effective therapies for CFS/ME.’

But they’ve read a virology blog and may be having second thoughts. (Interesting that there’s no mention of the PACE trial here, by the way.)

‘After a period of illness most people find that they take some time to recover. During this recovery period we tend to avoid physical activity and rest more than usual. When we do less each day our body loses fitness and strength in a physical process called deconditioning. The result of deconditioning is that we become physically tired much sooner…’

‘The inability to function as before leads to frustration and an eventual lack of motivation for any physical activity. This starts a vicious cycle of avoiding activity and increased fatigue which then results in further deconditioning. The aim of GET is to break this cycle.’

That’s clear enough. They’re saying that CFS/ME is caused by deconditioning. This is a form of what they call ‘false ideation’. We think we’re ill but we’re not. So why does it say in the GETSET paper that ‘the relative efficacy of a behavioural intervention does not imply that chronic fatigue syndrome is caused by psychological factors’? This programme of treatment seems to be based on the supposition that it is caused by psychological factors. There seems to be incongruity at the very heart of the study. (Of course, there is plenty of evidence that ME is caused by some form of ongoing pathology rather than deconditioning. Is that why they’re fudging the issue?)

‘Regular physical activity is known to have considerable benefits: it improves the efficiency of the heart, lungs and circulation and generally helps the body to deal better with the demands of daily life.’

Unless of course some of the patients have ME. (I wonder if they’ve checked on that yet?)

‘It will be easier to keep exercising on a regular basis if you enjoy what you are doing. It could be an aerobic exercise such as walking, cycling, swimming; a home or gym based exercise programme; or just increasing things you do at home such as housework (e.g. vacuuming), gardening, or climbing stairs.’

I thought I read somewhere that research had shown aerobic exercise wasn’t good for people with ME. Or was that because they hadn’t chosen a type they enjoyed enough? If only I’d swum with dolphins instead of the vacuuming…

‘Your muscles can feel heavy after exercise, and you may feel physically tired. With CFS/ ME these feelings of physical tiredness can be more intense, but they will also help you sleep.’

Yes, as any person with ME will tell you, intense pain and exhaustion are just the thing for a good night’s sleep.

‘If you do have a setback, do not despair. They are relatively common in people with CFS/ME and you need to develop a plan to deal with them.’

You may find the longer this goes on, the more ‘relatively common’ your setbacks become. A good plan to deal with them may be to leave the trial.

‘If your setback is not CFS/ME related, in other words you have picked up an infection, you should reduce the amount of exercise you do, or even stop altogether for a short while, before returning to your GET programme. If your setback is CFS/ME related then you should try and continue exercising at your current level to the best of your ability.’

So if you get a cold, that could be serious so you need to stop for a while, but if it’s just ME, there’s no need to worry: just press on…

‘It is often incorrectly assumed that an increase in symptoms equals harm. It doesn’t.’

Glad we cleared that one up. This may explain why no harms were reported on the trial. Do they concede there’s a harm if somebody actually dies, I wonder?

‘If you continue at the exercise level you are on now you may well find that you feel no worse, and after a short while you may actually feel better. Remember that although you may not feel like exercising during a CFS/ME related setback, by resting too much you can quickly lose the physical gains that you have made. Setbacks are a normal part of recovery and so it is important to remain as positive as possible. As you get stronger you will find that you have fewer setbacks and they are less severe and last a shorter time.’

Somewhere over the rainbow…

In the next post, I’ll move on to look at the focal figure of the GETSET Guide, Julie, who has already become an internet phenomenon…

 

My Perspective on the MEGA PAG

At long last, I’ve submitted my list of reasons for resigning from the MEGA patient advisory group to the MEGA team, the other PAG members and a few other interested parties. I would like to be able to share it in full here but unfortunately the confidentiality agreement makes that impossible. So I shall stay with it as long as I can and then add in a few extra comments exclusive to this blog. Well, OK, quite a lot of extra comments…
Here we go…
I joined the PAG in the expectation that we would be able to make a substantial contribution to the design of the MEGA project, in particular the patient cohort selection, about which there had been considerable concern in both the ME/CFS research and patient communities. Recognition and  understanding of ME/CFS has been greatly hindered for many years by the muddled and inconsistent use of a host of diagnostic criteria. This problem was acknowledged by the recent US National Institutes of Health ‘Pathways to Prevention’ Report  and highlighted in a recent paper from the Cure ME UK Biobank team. It is recognised that broad criteria are needed for GWAS, but nonetheless it is of course extremely important  to select the right patients for the MEGA biobank, particularly as they might be used for research worldwide for many years to come. There has been particular concern because the MEGA team Principal Investigator, though regarded as an ME/CFS expert by her close colleagues, did not – to judge from her previous work – appear to have taken on board the importance of such distinctions.
Prior to the formation of the PAG, patient concern was to some extent allayed by assurances about the extensive role of the patient advisory group, both on the MEGA website and in person by Prof Holgate when he addressed the Forward ME Group at the House of Lords.
The MEGA website announced that provisions would be made for the PAG as follows:
We will:
  • use technology to make it as easy as possible to participate, given the limitations of the illness
  • ensure you are clear about your role and responsibilities
  • always treat you with respect and compassion
  • provide you with support that fits with your role and your needs as well as ours
  • always value the role you play in our team and the contribution you make to our work
  • listen to, and act on, feedback that you give to us outlining what we did/didn’t do and why
  • ensure you have the information you need to participate in the wider MEGA team effectively.
At his meeting with Forward ME at the House of Lords in December, Prof Holgate further explained:
  • the selection of patients would not be looked into until the PAG had been convened
  • the PAG would need to get together with the MEGA team to resolve the many queries that surrounded the condition of ME/CFS patients.
  • the PAG’ s method of working would be a matter for the PAG to decide. Each patient representative would be an equal of every other member of the MEGA team
When asked about the inclusion of the full spectrum of patients in samples for the study, Prof Holgate said:
  • this was a discussion the patient representatives would need to have with the scientists
The MEGA website summarised the role of the PAG as follows: “to provide people with ME/CFS, their carers, and people with an interest in ME/CFS, with a full voice in advising and collaborating with the MEGA team to inform all stages of the MEGA study to better understand the biology of ME/CFS. Advisory Group members are asked to contribute to the MEGA study by:
  • actively engaging in the design of the MEGA study and to be participants in its conduct
  • identifying any potential practical issues for participants, questions, gaps or concerns about the study and to comment on study documents and procedures
  • contributing to, and informing, the planning process for securing funding, recruiting participants and disseminating results.”
Sadly, my experience was that the vast majority of these numerous assurances were ill-founded. The reality of the PAG differed greatly from what had been promised.
In the report I submitted, I went on to give examples of numerous ways in which the reality of the PAG fell short of what had been promised, but unfortunately I’m not able to share them here due to the confidentiality agreement. What I can do instead, I think, is to bring in my experience of patient involvement in research into another neurological condition I have. This has involved answering questions about how far people would be prepared to travel to undergo tests, and whether they would be prepared to go without their medication for part of the day while doing so, that sort of thing. In other words answering important but relatively mundane questions about patient participation in the practice of research.
In our discussions amongst ourselves in the PAG, we referred to this as working in a ‘consultative’ capacity, whereby the group would be approached to answer such questions as and when they were needed, an important role yet a very different one from that of collaboration, which was what we had been given the impression would be required from us for MEGA. At the time I left the PAG, some two and a half months in, it was still not clear which of these roles we were supposed to fulfil. We had certainly been told we would be collaborating, more specifically we were to be provided with “a full voice in advising and collaborating with the MEGA team to inform all stages of the MEGA study”. The trouble was that to judge from our experience so far we were really only wanted in a consultative capacity. “To decide on the best colour for the envelopes,” was how I liked to describe it. Which was a joke – but admittedly not all that funny.
Though things were much more complicated than I have been able to describe, it was this uncertainty about the role of the PAG and the failure to get agreement on terms of reference which might have defined it, together with frustration about having such little scope for input into the project, which led to my resignation. Our attempts to get more clarity led to a souring of the atmosphere and it was hard to see how progress could be made. Far from being welcome partners in the development of MEGA, we seemed to be barely tolerated. Three of us felt that the time had come to resign.
My best guess about what happened is that we were always intended to be consultative but when patients protested so loudly about the plans for MEGA as originally announced, the PAG was seized upon as a way to quieten us down: “Don’t worry – the PAG will be there to make sure it’s all done properly!” Prof Holgate even went so far as to tell Forward ME that “PAG members would be the equal of every other member of the MEGA team” which I have to say struck me at the time as neither likely nor even desirable. Personally speaking, as someone who knows next to nothing about –omics, I wouldn’t expect to have the same authority as an –omics scientist on an –omics research project. But I suppose when your mindset is simply to say whatever it takes to get the troublesome patients off your back, you don’t stop to think too much about accuracy.
You’d have thought, though, that they would have had a plan to deal with the situation when the PAG turned up and – surprise, surprise – expected to have, if not the impressive powers they had been promised, at least some say in the matter. Wasn’t it reasonable for us to believe what we (and Forward ME) had been told?
Except perhaps, now I think about it, there was a plan to deal with the situation: to ignore the PAG until the more troublesome members resigned in frustration then turn on the charm with the rest.
So maybe it’s me that hasn’t thought this through…
But I can’t help wondering how the Forward ME representatives must feel about being given such a misleading impression of how things would be for the PAG? When they asked all those questions of Prof Holgate at the House of Lords, would they not have expected a higher degree of accuracy in the replies? Or are we in a situation where anyone in power can say  whatever they like, regardless of the facts? While patients are cast as troublemakers however much truth they have on their side…
Anyway, what happens next?
People have been asking if more resignations from the PAG are likely. My impression at the time was that others were considering it, but now I’m on the outside with everyone else, I don’t really know. According to the latest update on the MEGA website, “enthusiasm among PAG members is high” and since our departure “things have really picked up and are starting to fly”. If, as the website also reports, the PAG really had “substantial input” into the bid then things have changed a great deal for the better. If I’d known I was holding things back so much, I’d have gone before…
After the mistaken impression previously given about the role of the PAG, however, I hope I will be forgiven if I don’t entirely trust the MEGA website. The recent update reported that three of us had left the PAG and that our “ reasons for leaving have been taken on board”. This was particularly surprising as, at the time that update appeared, two of us hadn’t yet submitted our reasons for leaving. The update also stressed the intention that MEGA will apply for additional funding to include samples from the severely affected and that PEM will be a prerequisite for inclusion in the study. All of this, the update announced, had been agreed with the PAG. Well, OK, but both these strategies had already evolved before the PAG was even formed. They could hardly be described as a breakthrough now. If they had found a way to include the severely affected in the initial bid, then that would be news.
On the other hand, the update does at least acknowledge that those affected long term (who may not necessarily be severe) must also be included and it appears there has been some discussion of categorisation of samples. It is not much to go on but perhaps things are taking a turn for the better. It is not before time.
I certainly felt that the PAG had a great deal of expertise that was being wasted till now. There are some good people still in the group and I hope they are finally getting a chance to be heard. I’m sorry if my departure has increased the load upon them. I wish them all the best in their efforts to make their mark on the study. It is always hard to be sure of the root of things and perhaps the previous shortcomings of the MEGA/PAG relationship were due to oversight and circumstance rather than intent. Perhaps it is not too late for things to change.
And yet….
I’ve been torn in writing this post because I want to support my friends that remain in the PAG in their efforts to make MEGA better. I’m sure they will give it all they have but the honest truth is I don’t share their optimism. If I did, I suppose, I wouldn’t have resigned from the PAG. If things have changed for the PAG, I suspect it has more to do with spin than substance. I have to judge the study from my own experience, not from a single upbeat blog post. I have to look at the Principal Investigator, her previous work, the gulf between the promises and my experience of the PAG, the feeling of being played along just enough to keep us in tow. I think patients and informed professionals are right to express continued concern about the study. I have feared all along that it is likely to hinder rather than help our understanding of ME because of the way the patients are chosen and I’m afraid I have seen nothing to change my mind.

Natalie Boulton – MEGA PAG

Hello – I’m back from the MEGA PAG. It didn’t go too well. I’m afraid.

Yes, I know, you told me so…

I’m still trying to work out how to report what happened without falling foul of the confidentiality clause. In the meantime, here’s an account from Natalie Boulton, co-producer of the Voices From The Shadows film, who left at the same time as me. This also appears on Natalie’s Voices From The Shadows Facebook page:

Three members of the MEGA patient advisory group resigned last Friday 17th March – myself Natalie Boulton, ‘Spoonseeker’ and Jim Wilson. ‘Spoonseeker’ writes a well informed and thoughtful blog, I made the collaborative book ‘Lost Voices from a Hidden Illness’ and co-produced/directed the film ‘Voices from the Shadows’; an advocate for ME patients like my daughter and her friends. Jim is a former research physicist and computer scientist. He has a wide ranging professional experience in senior business management and of delivering projects in both direct management and board level oversight roles, which involved partnership in working across organisations and cultures. He is also a trustee or chair of several charities. The professional experience he brought to the PAG has been invaluable. Both he and I are carers for daughters ill with ME. Spoonseeker is himself a patient and also a carer for his wife who has ME. A very active member of a ME support group, he has had a long involvement with a wide range of patients and their experiences. We all took our support for, and participation in MEGA, very seriously. We expended an enormous amount of effort and time on it; committed to applying our varied expertise to the project in a constructive way. I think the other two will soon make their reasons for resigning public, in so far as they are permitted to by a confidentiality agreement. Keep an eye on Spoonseeker’s blog for their accounts. I restrict this account to my personal impressions and publicly available material.

I applied to join the MEGA PAG believing that the public specification for the patient advisory group was a serious commitment to ME patients and to PAG members – at least until a more comprehensive Terms of Reference was agreed with the PAG. I also believed that the information given to Forward ME by Prof Holgate, to allay concerns expressed by the Countess of Mar and ME charities about MEGA, could be depended on.

I now find, almost three months since the PAG was formed, that both this public commitment and Prof Holgate’s answers have turned out to be misleading. Furthermore, no terms of reference have been agreed, to enable the PAG to operate effectively, despite this being a priority, and the minutes from the only meeting held while I was a PAG member ( last December) have still not been confirmed or made public.

I am, therefore, concerned that patients and ME charity representatives have been misled. In my view, over the last three months, the PAG has not been permitted to carry out the functions publicly ascribed to it. As an advocate for severely ill ME patients this puts me in a difficult position. Members of the PAG have been working and studying incredibly hard, both individually and collectively, in order to be in the best and most informed position to assist the MEGA team who, as a group, have very little knowledge of ME/CFS. I believe we are all desperate for good quality, relevant research to be done on ME and ME/CFS, so I have found it intensely frustrating to find our efforts to engage thwarted at every step. I have not felt that the PI representing the MEGA researchers has a genuine wish for a meaningful engagement with the PAG, nor for the collaborative relationship many PAG members hoped for and have been working towards. Now, sadly, my impression is that the PAG was hastily appointed at the last minute as a cynical attempt to try to make bioresource bids look more appealing to funders and to reassure patients.

I have not found an honest and open environment for discussion between PAG and PI. At the only official PAG meeting before I resigned, it became clear that critical design issues for the MEGA project had already been decided upon and were non-negotiable: no meaningful discussion of these issues would be permitted. All further research by MEGA researchers, whether a broad ranging Genome Wide Association Study or more in-depth research, will depend on the samples collected for the MEGA biobank, so the selection and identification of patients is crucial, as Prof Holgate and others including Prof Davey Smith have pointed out.

At her recent inaugural lecture, the PI made clear her understanding of ME/CFS in children as being a very common condition, responding very positively to the behavioural management regimes found to be so flawed in adults. She also expressed grateful thanks for the assistance that she has received from Profs. Peter White and George Davey Smith over the last 10 years, with helping her win research funding. Peter White is the psychiatrist who led the PACE Trial. George Davey Smith is an excellent researcher, but says he knows nothing about ME/CFS, even after 10 years of being associated with CFS research as Bristol University. As a PAG member I have seen no evidence that the MEGA biobank PI is willing to allow those who have lived with and developed a more realistic understanding of the severe illness known as ME, to engage in meaningful discussion about the selection of patients and to listen to our concerns about the potential danger of particular groups being under-represented in the biobank and even in a GWAS.

ME has a long history of definitions and criteria being used in a very ‘creative’ manner.
I decided a couple of weeks ago that, as an advocate for those with severe and long lasting ME, I could no longer remain a PAG member in a project whose value to ME patients:
1. relies entirely on how a few significant terms – such as PEM – or ME/CFS – will be defined at some future date
2. where crucial decisions, which will impact on future options, were made without any in-depth discussion being permitted
3. where no working relationship or discussion has been allowed between the PAG and MEGA researchers.

Since impending resignations were known about, there seems to have been a frantic attempt to placate criticism from the PAG, but this does not restore my confidence in the overall MEGA biobank project.

There has been a history of legitimate patient concerns being dismissed as harassment and persecution, even when these concerns are raised at terrible cost to patients own health. I hope that researchers, patients, carers and ME charities will recognise the legitimacy of the serious concerns raised by the resigning PAG members, rather than dismissing them and relegating them to the ’persecution of brave researchers by nasty patients’ narrative.

MEGA Patient Advisory Group

For better or worse, I found out today I’m on the MEGA patient advisory group. ‘Mixed feelings’ is the best way to describe my reaction. I ‘m pleased that I may have a chance to make a difference to the study but aware that it might not be easy. I will do my best…

In the meantime, if anyone who is reading this has also been accepted onto the group, please get in touch. I only know of two other members so far. It will be very useful for us all to be in contact.

 

Spreading the Word

privateeye-hammond-dec2016-web

Dr Phil Hammond’s latest column in Private Eye is called ‘Trial on Trial’. You may remember he wrote quite a helpful column about ME just recently. This time he writes in response to criticism from a doctor who got in touch to say:

“Every illness has a physical, psychological and social component, and limiting diagnosis or treatment to only one aspect of someone’s illness is likely to lead to a much poorer outcome. This ‘triple diagnosis’ applies to any complaint you care to consider, although obviously in varying proportions. The one exception seems to be CFS/ME, where any suggestion that there might be a psychological or social component leads to criticism. That CBT is the only treatment which has repeatedly been shown to have any benefit is conveniently ignored.”

It does become tiresome having to deal with such ‘arguments’ time and time again. Once upon a time it was ‘yuppie flu’ that popped up in every article about ME. Now, at long last, that is slowly fading away. Yet now we have to deal with this endlessly repeated idea that ME patients have an unreasonable and unsubstantiated resistance to any suggestion that there might be a psychological component to our illness. People with cancer are happy enough to go for CBT, we are told. So what’s our objection? Continue reading “Spreading the Word”

Eleven Days of Christmas

Well, in my previous post (a few hours ago), I did say to take a closer look at the MEGA site in case there was something I’d missed – and too right I was. I had failed to read the new MEGA blog post, thinking that it was just about the change of deadline for applications to join the patient advisory group. I hadn’t realised that it also provides a schedule for subsequent weeks. Here it is:

  • 9am 13 December 2016 – Deadline for applications to join the MEGA Patient Advisory Group
  • 13-14 December – Applicants contacted and group members confirmed
  • w/c 19 December – Papers and key information sent out to Patient Advisory Group members
  • 29 or 30 December – Patient Advisory Group teleconference and/or e-group meeting held
  • 4 January 2017 – Back-up call for Patient Advisory Group if needed, to address outstanding issues from December meeting.

So patients are to be given a maximum of eleven days to read the ‘papers and key information’ before discussing it and -presumably – suggesting possible alterations in a teleconference or e-group meeting over the Christmas period! So not only are they expected to do this over Christmas, but the twelve days of Christmas has been shortened to a maximum of eleven. Notice the w/c in there – not meaning ‘toilet’ in this instance (although some might think this an appropriate place to sling the schedule) but ‘week-commencing’, so the papers could theoretically arrive any time that week, which might be as little as six days before the conference.

At least they accept the possible need for a backup call ‘to address outstanding issues’ and also feel that some explanation is due. They say:

The reason that the timescale is so short is because the mainstream funder to whom we want to apply for MEGA funding has an application deadline in early January 2017. This deadline was only recently announced and was different to the timings we expected.

and:

If we miss the deadline for this funder, we will not be able to apply again until 2018.

Even so, to use an old joke from Have I Got News For You, the words piss-up and brewery spring to mind. And of course many will say that they’ve carefully planned it like this to deliberately discourage and marginalise patient involvement. I can fully understand that point of view. If MEGA really want to win back the trust of the patient community, they are not going the right way about it.

Does this make an difference to my decision to apply for the patient advisory group? I’m still processing that one. But I’m getting more and more annoyed. Three more words have sprung to mind: ‘taking the’ and ‘piss’. And it’s not us that’s doing it…

(My normal pristine standard of vocabulary will be resumed in the next post.)

See also this OMEGA post which I should have read yesterday, including pertinent comments by Peter T.

Taking a Closer Look

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 Continue reading “Taking a Closer Look”

FITNET Fiction

Here’s my latest response in the ongoing dialogue with Professor Holgate, CMRC Chair, about the proposed MEGA study:
Dear Professor Holgate
Thank you for your response to our email. I have not been able to consult with all the 218 people who signed the original communication but those whom I have been in touch with have expressed considerable disappointment that you did not attempt to address the specific issues we raised in our letter.
However, I await the new website with interest and hope that the FAQ section will at least deal with the two main issues we mentioned in relation to MEGA:
  •  the recruitment of a representative sample of patients (including the severely affected) who have the cardinal ME symptom of post-exertional malaise, and
  •  the suitability of Professor Crawley to take charge of such recruitment given the highly imprecise nature of her previous work in this field

Many people who signed the previous letter also left relevant comments Continue reading “FITNET Fiction”