Category: Advocacy

The NICE Guidelines – Starting Again?

N.B. Please sign the NICE Guidelines Committee petition – see below.

There was some encouraging feedback from the recent NICE ME/CFS Guidelines Stakeholder meeting, an early milestone in the long process of revising the guidelines. But was such encouragement justified? I wasn’t there myself, so I am grateful to those who attended on our behalf. Blogger and patient advocate Sally Burch reported that Guidelines Director Prof Mark Baker declared: “We’re going to tear it up and start again. We won’t allow it to look the same” while Prof Jonathan Edwards reported as follows (writing in the Science for ME forum):

“What intrigued me most was the elephant in the room – the reason why we were there at all, which was not mentioned once by the speakers from the floor and I suspect hardly at all even in the groups – the need to remove recommendations for CBT and GET. It nevertheless became clear that the NICE staff were absolutely clear that this was why we were there and that they had taken on board that this was not an issue for a few minority activists but essentially for all patients. At our table the facilitator said ‘I presume everyone here is agreed on that’ – despite the fact that a paediatrician and an occupational therapist were present who I suspect may not have realised this was why we were there and for whom these remained standard practice”.

All this talk of ‘tearing it up’ and scrapping CBT and GET was less in evidence however, in the letters which Prof Baker exchanged with Kathleen MCCall (who was representing the Trustees of Invest in ME). Writing in advance of the Stakeholder meeting, Prof Baker wrote: “I appreciate that the existing recommendations are a matter of concern to some patients and groups and we will give some consideration to whether we need to modify or omit any of the existing recommendations during the development of the new guideline”.

This does not exactly sound like ‘tearing up and starting again’ so when the feedback from the meeting emerged, Invest in ME wrote again to question the discrepancies. This time, Prof Baker’s response was of particular interest. He wrote:

“I did indeed say that we will fully replace the guideline and start again…. However, it does not mean that we reject everything that is in the current guideline.”

So this sounds like parts of the guidelines are to be torn up then reinstated, which is easy enough with a roll of sticky tape but a bit confusing for those trying to gauge the mood music at NICE. Prof Baker goes on to explain:

“The problem is, I believe, in the unthinking and ill-informed manner in which the recommendations are imposed on people for whom they are not intended and/or not suitable… I was struck by some of the stories at the workshop about the misuse of the current recommendations and the disturbing extent to which they are imposed on people who are unlikely to benefit from them and for whom alternative approaches would be sensible… The current wording makes clear that patient agreement is required but I imagine that consent is not usually sought and that patients are not considered to have rights to refuse (which they invariably do have in fact).”

So it seems that Prof Baker is at least convinced of the need to safeguard severely ill patients, who do indeed all too often have GET imposed upon them – in clear violation of the existing guidelines. This crucial change is to be encouraged, of course, as is the need for all patients to be informed they have the right to refuse treatment. How exactly this is to be achieved is another matter however. As “the current wording makes clear that patient agreement is required”, what do you do to ensure such agreement is sought? Perhaps the addition of the words “we really mean it this time” in bold print would do the trick. The wholesale removal of GET from the guidelines would be more effective, I suspect, but to judge by Prof Baker’s letter to Invest in ME, that doesn’t appear to be on offer.

He says: “scrapping the entire guideline now would be massively counter-productive as it would almost certainly result in the withdrawal of the already dwindling number of services available to people with ME. Therefore, a rather more limited approach would be required to protect what is good whilst modifying what may be harmful”.

So in spite of saying he wants to tear the whole thing up and start again, Prof Baker clearly believes that bits of it are good and need to be protected. I can’t avoid the growing suspicion that these bits might include CBT and GET. Indeed, if not CBT and GET then what? A large part of our problem is that when it comes down to what purports to be ‘evidence-based’, there isn’t anything else. Of course the ‘evidence’ for CBT and GET is extremely unconvincing, as David Tuller and others have illustrated time and again, and the reason there isn’t the evidence for anything else is that CBT and GET – and the misapprehension about the condition which their adoption has brought into being – have effectively put paid to biophysical research for many decades. This sad circumstance may give us the moral high ground – from the perspective of those who understand – but it doesn’t actually help.

As Jonathan Edwards puts it: “All in all it seems to me that something important has been achieved but there is still more work to do. NICE are very clear that the great majority of patients believe that CBT and GET are worse than useless. They realise that a committee must not be made up entirely of psychiatrists. However, when the committee comes to look at the evidence the only evidence for treatments working they will find will be on CBT and GET. It is going to be hard for them to not at least mention that there is supposed to be some evidence. Hopefully that will not be followed by a recommendation. However, I sense an attitude even amongst physicians and paediatricians that if CBT and GET are not available they will have nothing to offer. A lot of doctors find that uncomfortable. They should not but they do. So there will be a tendency for CBT and GET to remain in the guidelines even if watered down. That will depend to a degree on who is on the committee. That needs some thought. Applications are being taken in June and July.”

So yes indeed, the personnel on the committee will be of vital importance. Graham McPhee, John Peters, Sally Burch and numerous other patient advocates have written a letter to NICE requesting that the committee members are chosen with openness and integrity. They have also produced a petition which anyone can sign. Over 2,700 have done so already. If you haven’t signed yet, please consider joining them.

This is important. As Jonathan Edwards says, doctors feel uncomfortable if they have nothing to offer. This unfortunate fact is the reason why so many patients with physical illnesses over the years have been treated as though they have a mental health issue. It probably won’t help the patient but it’s better for the doctor than feeling powerless.

Sad to say, CBT and GET may remain in the guidelines for this reason, if for no other. They haven’t been torn up yet. We can’t even be sure that Prof Baker’s proposed amendments to avoid the inappropriate imposition of these ‘treatments’ will be acted upon, as he is due to retire before the new guidelines are finalised.

It is good that many patient advocates attending the meeting left with a good feeling about it but, as I am sure they realise, the battle is far from over yet. As a starter, we need the right people on the guidelines committee. Don’t forget to sign that petition…

Update: Apologies for my previous PS about the Royal College of Physicians (which I’ve now removed). It turns out I was quoting the wrong Royal College from the table. I hate to spread misinformation so many thanks to Annie who left a comment to set me straight. Nevertheless, as she points out, there is no reason for undue confidence in the RCP who are to take a leading role in the guidelines revision. Annie writes as follows:

“Excellent summary of where things stand so far with the review of the NICE guidelines.

“One point though the worrying comment you cite from the stakeholders comments during last summer’s consultation exercise was made by the Royal College of GP’s, not the Royal College of Physicians if I am reading the table correctly on page 89? Nonetheless, the Royal College of Physicians said they endorsed the comments of the Royal College of Psychiatrists and the neurologists whose submissions were poor and inaccurate and did not want the guidelines updated, so I am still not filled with confidence having the Royal College of Physicians so heavily involved.”

 

Have You Been Harmed by PACE?

Dr Sarah Myhill has written a comprehensive letter of complaint to the General Medical Council about the conduct of the authors of the PACE Trial. You can find the full text here. This is a courageous letter which states very publicly and unequivocally what a great many patients have been saying for some time: that in the way they have conducted the Trial, the PACE authors are guilty of fraud.

Dr Myhill is asking for patients who have been harmed by the Trial to support her by sharing their experience with the GMC using a template letter which can find it in a Word document here. Please try to find the time and energy to do this if your health allows. Dr Myhill is taking on a lot in trying to help patients in this way. I believe she deserves the support of us all in return.

Craig Robinson, from Dr Myhill’s team, explains in more detail as follows:

*** DR MYHILL HAS COMPLAINED TO THE GMC ABOUT THE PACE AUTHORS ***

*** SHE WANTS YOUR HELP ***

**PLEASE DO COPY YOUR LETTER OF SUPPORT TO cr648@hotmail.co.uk – if you feel comfortable with doing so**

PLEASE SHARE THIS POST AS WIDELY AS POSSIBLE. THIS COMPLAINT IS IN THE PUBLIC DOMAIN.

The GMC is the UK doctor’s regulatory authority – the General Medical Council. Patient support is sought from all patients who feel they have been harmed by PACE. You do not have to be a UK citizen.

PACE is the study ‘Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. (2011)’, published in The Lancet.

SEVEN other medical doctors are supporting this complaint but wish to remain anonymous – they are concerned about the impact of such “whistle-blowing” on their future careers within and without the NHS.

The complaint is one of Fraud, namely:
–fraud by false representation
–fraud by failing to disclose information
–fraud by abuse of position

There are also numerous breaches of:
–GMC Guidance on Good Medical Practice
–GMC Guidance on Good Practice in Research
–GMC Guidance on Consent to Research

Dr Myhill is asking for your help.

Please read the letter of complaint and also the ‘PACE patient support letter‘.

HELPING DR MYHILL

We want people who have been harmed by PACE to write in support of this complaint. You are free to use the PACE patient support template letter. You could have been harmed in any of these ways and possibly others too (please see further notes about this further down the post) :

• suffered damage (including physical, mental or emotional distress) as a result of CBT.
• suffered damage (including physical mental or emotional distress) as a result of GET.
• been denied disability benefits because the physical nature of your disease has not been properly recognised and/or you have been told you have a psychological condition.
• have been denied industrial compensation for your disease because the physical nature of your disease has not been properly recognised and/or you have been told you have a psychological condition.
• have been denied referral or funding for referral to a physician specialising in the biomedical approach to treating CFS/ME.

You do NOT have to have been diagnosed or have fallen ill with CFS/ME after PACE was published [March 2011] to support this complaint.

So, for example if you were diagnosed/fell ill in 1980, but have recently been refused benefits as a result of PACE [for example, for not engaging in CBT or because your illness was considered psychological) or maybe you have suffered mental distress as a result of PACE (for example, benefit applications were more stressful because your illness was considered psychological) then you CAN support this complaint. It will help our case to have as many support letters as possible.

If you feel you have even the smallest ‘case’ for inclusion then please do submit a letter of support – it is incumbent on the GMC to prove that you have not been so affected, not for you to prove that you have!

Please do email if you are in doubt or need help phrasing why you have been harmed by PACE. Please be patient – we will respond as quickly as possible. See the hotmail email address below.

Just put your reasons for supporting this complaint in the relevant section in the PACE patient support letter and fill in any other portions that need filling in [all marked in red] and then:

1–email it to TStephenson@gmc-uk.org – Sir Terence Stephenson is the Chair of the GMC

2–if you can, please send your letter by post too, here is the address –
Sir Terence Stephenson
General Medical Council
Fitness to Practise Directorate
3 Hardman Street
Manchester, M3 3AW.

3—if you feel comfortable with doing so, please can you copy your letter of support to Dr Myhill at cr648@hotmail.co.uk [in the past the GMC have denied receiving letters of support and having physical copies to collate and send to them has been a very powerful tool]

GENERAL COMMENTS

We cannot engage in a running commentary on progress but will give updates as and when possible and necessary.

We know that GMC employees or people who report to the GMC are members of the Dr Myhill groups and so we do have to be circumspect.

You may feel that the letter of complaint could be improved – good!

In 15 years of dealing with the GMC, and other regulatory bodies, one thing above all has become clear: these regulatory investigations are like a game of chess. A marathon not a sprint. You have to plan 6 moves in advance…

Essentially, we are saying – trust us! Between us we have won 30 GMC cases as defendants and numerous cases across many regulatory bodies as complainants.

Thank you.

Here’s Craig again with an update:

N.B. The harm done to you does NOT have to fall within the 5 broad categories listed in the template letter. ANY harm or ANY DISTRESS caused by PACE is ”enough”. See as follows for an example of how another patient has put it in her great letter:

  • I have suffered mental distress as a result of PACE. For example, benefit applications, and assessments were more stressful because my illness was considered psychological
  • Visits to doctors, and consultants, and NHS emergency departments are more stressful because my illness is considered psychological.
  • I am denied treatment because my illness is considered psychological
  • I am accused of wasting time, and lying, and treated with contempt and suspicion because my illness is considered psychological
  • My word and experience is dismissed because my illness is considered psychological, and I am labelled as ‘mentally ill’.
  • I am labelled as a delusional patient because of negative connotations implied by doctors and NHS staff.
  • It appears all my other health issues, and concerns are now considered psychological, and therefore dismissed as imaginary
  • I experienced extreme trauma, HARM & LOSS because my illness was considered psychological
  • I was targeted, and harmed after complaining, because my illness was considered psychological
  • I am denied compensation for my disease because the physical nature of it has not been properly recognised and/or told I have a psychological condition
  • It is my belief PACE WAS AT THE ROOT OF THESE PROBLEMS

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.

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”

Why We All Need To Sign The OMEGA Petition

((Please note that I am not involved in organising the OMEGA petition.))

It’s taken me a while to sign up to the OMEGA petition because I’ve really wanted to find a way for the MEGA ‘biomedical research’ study to work.

Steps could be taken to improve the original proposal. As suggested in the previous post, the patient sample could be obtained not from the NHS clinics but from the existing UK Biobank. There are nowhere near enough samples in the Biobank at present but there is already funding for more, and more samples still could be added as further funding is obtained. Using the already established methodology, with patients coming through GPs, this could produce a reliable sample with the focus on PEM. There would be plenty of severe and moderate patients and – if my rudimentary understanding of ‘big data’ is correct – the sample need not be as large as the one from the clinics as patients with other fatigue conditions would not be included.

If Dr Charles Shepherd – or someone appointed by him – could be in charge of this then I am sure that the majority of the patient community would get behind the project. But would such a switch be achievable? That is the problem. The word is that Prof Esther Crawley is in charge of patient selection – and is unlikely to want to change the way it is done.

The involvement of Prof Crawley, of course, has been one of the main reasons why patients have been uneasy about MEGA right from its first announcement. Yesterday’s publicity about FITNET, Crawley’s upcoming online CBT study, has come as a timely reminder of why that is.

Yesterday’s reports were brimming over with misinformation. Continue reading “Why We All Need To Sign The OMEGA Petition”

A Broader Picture

The last draft post I wrote about the MEGA petition was superseded by events before I finished it, so I’ll try and crack on with this one before the same thing happens again. Of course ‘cracking on’ in ME terms is still kind of slow but I’ll see if I can break the tortoise barrier.

So, what’s happened recently?

Well, we’ve been told that Peter White is retiring from research and will only be an ‘advisor’ to MEGA from now on. This perspective appears to be endorsed by the latest list of MEGA personnel, which no longer includes him. I can only give a muted ‘hurrah’ to this one. Advice is dangerous stuff and you can still do a lot of damage with it. His PACE Trial is swiftly becoming a watchword for bad science (see here, here, and here). Is he really the sort of ME ‘expert’ that either we patients or the MEGA team want around to guide this latest project?

It really is astonishing that MEGA apparently do still want him around after all he has done, and that they clearly expect patients to put up with it. It seems to me that if a passing Martian was given a brief course in English and the full facts, then even he (or she) would swiftly understand why we don’t want Prof White anywhere near this project. Why do the MEGA team not get this?

People with ME have  been left on the scrapheap for decades. I myself have been ill for over thirty years. That’s over half my life. I have no children because of it. I lost my job. My life is very limited. Yet I am one of the relatively lucky ones. I can sit and tap at this keyboard – as long as I take plenty of rests to fend off the shoulder and eye pain and overall exhaustion. There are plenty of others who have to spend all their lives in bed, who can’t stand the light, who can’t even talk to their loved ones. We’ve all heard about Whitney Defoe whose birthday it recently was. He is not alone in his suffering. The vast majority of the severely ill are left to fend for themselves as best they can. Rarely do doctors come near them and they wouldn’t know what to do if they did.

And all this time, all these decades, so little research has been done, in large part because of the fairy story dreamed up by the PACE researchers and their associates: the fairy story that Continue reading “A Broader Picture”

MEGA Petition

Here is a copy of an email from Leeds ME Network sent to Sonya Chowdhury, CEO of Action for ME concerning the petition which she has been circulating regarding the proposed ‘big data’ study by the UK CFS/M.E. Research Collaborative. It is another situation, similar to the NIH study in the US – where the research sounds very promising but some of the personnel involved sound alarm bells. Leeds ME Network are therefore requesting more details and – hopefully – reassurances.

Dear Sonya – I am writing because I find it difficult to know how to respond to the MEGA petition which you have been promoting. Of course I am in favour of more biomedical research into ME. Normally I would sign this petition, circulate it to our members, and publicise it more widely on social media. Yet I am concerned about the presence of  Profs White and Crawley in the MEGA team. I am sure you are aware that many other patients share my reservations.

Following the recent release of data, it is now clear that Prof White and his PACE team deliberately manipulated the data to get the result they wanted, thereby deceiving patients, doctors, and decision makers both in this country and worldwide, Action for ME included. I know that your predecessor, Sir Peter Spencer, expressed surprise at the results of the PACE Trial. Well he might have done, because it is now clear that the published results were a travesty of the truth.

As for Prof Crawley, as you will be aware she is now about to test GET on children in the MAGENTA trial (in spite of widespread concerns about the PACE trial plus substantial reporting by patients of harms from this therapy), has recently been testing the quack therapy the Lightning Process on children, and has added to the substantial body of misinformation about ME by conducting a study of the prevalence of CFS at age 16 by using subjects who were ‘diagnosed’ by questionnaire and without the involvement of doctors.

In view of these issues. I’m afraid I have no confidence in any research involving either Profs White or Crawley and am therefore loath to sign or distribute the petition. But on the other hand, I would very much like to support biomedical research. I therefore feel I am caught between a rock and a hard place and it seems that many other patients feel the same.

I notice that ME Research UK have put a slightly different list on their web site: a ‘main MEGA team’ which does not include Profs White and Crawley. This makes perfect sense, as it is hard to see why either of them, given their skill sets and the nature of their previous work, should be involved in biomedical research anyway. So I wonder if their presence on the petition page is a token one only, acknowledging their membership of the Research Collaborative perhaps? If this were the case, if Profs White and Crawley were not actually to be involved in the big data project (and therefore not at liberty to subvert it), I might well feel able to support and publicise the petition. I wonder if you are able to advise me on this or else pass this email on to someone else who can?

I have just being listening to your presentation at the Research Collaborative conference in which you spoke very tellingly of the need for an appropriate level of funding for ME research. I am grateful to you for making this case and am sorry if you feel that I – and perhaps others – are ‘shooting ourselves in the foot’ by expressing such reservations about who is in charge of research. But experience has taught us that bad research is even worse than no research. The efforts of Prof White and the biopsychosocial school have been one of the main factors in reducing investment in biomedical research in recent years. It has taken patients many years – and a lot of energy we could ill afford to spend – to get to the stage where we are finally starting to expose the PACE Trial for the sham that it is. We cannot afford for the same thing to happen again.

 Note: I’ve been asked to include details of ‘unsigning’ in case you previously signed the MEGA petition and wish to un-sign pending further information about the study. I covered it here

The Light of Day

After long opposition (and substantial expense) from the trial investigators and Queen Mary University of London, data from the £5m publicly funded PACE Trial, which studied graded exercise (GET) and CBT therapies for ME/CFS, has finally been released under the Freedom of Information Act. ME patients Alem Matthees, Tom Kindlon and Carly Maryhew, with the support of two prominent US statisticians, have reanalysed the data according to the original trial protocol and illustrated that the recovery results were exaggerated by a factor of four due to unexplained protocol changes. The revised results were in fact statistically insignificant. This means that , in spite of what the investigators claimed, the trial provided no proof that GET and CBT help people with ME/CFS to recover.

Though those who have studied the trial have long suspected that the results as originally presented were grossly misleading, it is still a “gosh- wow” moment to actually witness the proof of this. One is tempted to ask “How did they think they would get away with what appears to be such a deliberate attempt to mislead?”

The answer appears to be that they calculated quite cleverly: they almost did get away with it. The professional reputation of the investigators had led many prominent people to assume that they must be in the right, and that the ME patients who have been fighting to expose the truth (whom the PACE investigators branded as ‘a fairly small, but highly organised, very vocal and very damaging group of individuals’) were unreliable obsessives, eager to discredit the trial simply because its conclusions did not agree with their own beliefs about ME. (In actual fact, the attempt to besmirch the patients in this way appears to have been a classic case of ‘projection’, the investigators having apparently twisted the figures to fit their own mistaken beliefs about the condition.)

Even now, it seems likely that they will stick to the strategy of claiming that black is white and relying on their reputations to Continue reading “The Light of Day”