Tuller Blog on Comments from NICE's expert reviewers (via FOI request)

user9876

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He was the statistician for FINE. Previously I thought he was good I have a book he wrote with someone else that I like. But any statistician who writes a letter to the BMJ quoting the mean (or mean difference) for both marking schemes of the CFQ doesn't deserve to be taken seriously.
 
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Mr 7 does seem to have made some relevant comments. Particularly the remark that the chair should not have anything to do with managing ME/CFS and not be a psychiatrist. But his requirements will easily be fulfilled without causing any ruffled feathers I think. He is brave to say what he does if he has co-authored with Wearden but I fear he has held back from saying anything really telling.
 

snowathlete

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I don't think so, I think this is to capitalise on FITNET. They do not believe phase 3 will show anything. If it does none of this is relevant anyway. NICE guidelines do not survive the stampede of biological facts for long. They held out against anti-TNF and rituximab for RA for a few months each but they could not keep up stonewalling. The problem at the moment is that there are no biological facts to get them with - not the sort that are needed. A positive phase 3 would overturn that completely.
If Rituximab is shown to work in ME then the BPS group will focus their efforts on two areas:
1. They will say there is not enough evidence yet, all the studies are from one group of researchers, there need to be more patients treated, there needs to be long-term follow up first.
2. They will claim Rituximab is not safe and will try and blow the realities here completely out of proportion. They have the SMC and other influencers and will try to scare everyone over it.

I think we need to start thinking about this now because they will fight hard to hold it up in these ways and we need to be prepared for that. I don't know the history of RA but I imagine they will be able to hold up Rituximab's approval in ME much longer.
 

Barry53

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An excerpt from #5's document 2. The "special form of CBT" sounds very much like GET, and it completely messed this lady up by the sound of it. She was told "to try out this practical approach because nothing will be lost by trying but much may be gained":-
But from June, I was enrolled on the PRINCE Secondary Trial. It was a trial where I had CBT
sessions – but the sessions were based on a special form of CBT which told me I had false
illness beliefs, and in every session I was given an exercise programme to do. The booklet I
was given said, “The best advice would be to try out this practical approach because nothing
will be lost by trying but much may be gained“. I was told to increase my exercising – so to
go on a 5 minute walk, twice a week, instead of the once a week I was able to do. I did what
they said, but was starting to feel more unwell than before, and told my therapist – she told
me to meditate more, rest more in between (although that was all I was doing in between
anyway!), and continue the walking. So I did. Then, she told me to increase it to 5 minutes,
three times a week.

I was given a booklet that told me that it was my beliefs that were perpetuating the illness,
that even if I felt unwell or got pains, or wanted to cancel plans, I should rethink it, and not
think negatively. I was having more and more “bad” days but kept going. The message was
that even if I got pains or dizzy or got tired, it was my body getting used to new patterns and
doing more exercise and I shouldn’t look into it too much.

I booked a trip to wilderness festival, thinking, well even though I am feeling more and more
ill, at some point my body will get used to its new pattern. and I still wasn’t as bad as I was
last August (when I first got ill) so I continued.

During wilderness, I became very unwell and had to come back early by cab all the way from
Oxford – by this point my body had gone numb and I was in tears. I came back from
Wilderness, and I went into hospital a few days later and was told I should get out of my
wheelchair and be more active. When I told them I often had a lot of pain in my arms, which
is why I couldn’t do a lot of things and needed help with having a bath, they told me to do
weights.

By this point in the trial, I was too unwell to travel to my appointments so was having
phone appointments – I was told to do a 10 minute walk. During the walk, my legs wobbled
and stopped being able to work properly. Despite this, I desperately tried to push through it
and did a yoga session a few days later (the trial therapist knew about the yoga alongside
the walking), as I had been told that that pain wasn’t a big deal. And that was when my body
finally collapsed in exhaustion. I had shooting, electrical-like nerve pain throughout my arms
and legs, it was terrifying and I couldn’t sleep with the pain. I had palpitations, my body
started shaking and twitching, I would burn up one minute and be freezing cold the next – I
was feverish for over a week.

I got even worse orthostatic intolerance, which means I couldn’t tolerate being upright or
even sitting upright, sometimes even for more than a few seconds without feeling nauseous
and dizzy and shivery. I felt sick all the time, found it difficult to tolerate food (or even sit up
to eat) and the headaches were there all the time. My brain felt foggy. I became sensitive to
light, and sound, and had to lie in a darkened room or I would get palpitations. The smallest
thing I did- even eating a few spoons of breakfast, meant I had to lie down for hours to
recover. I needed my mum and my boyfriend for every single thing. I couldn’t walk a few
steps or type without horrendous pain. I couldn’t talk more than a few words or the
exhaustion was too intense. I could drag myself to the toilet next door a few times a day,
and and that was enough to make me more unwell. All in all, I was back to how I was last
year.

This relapse happened in the middle of August. It is now a month on from that, and
although I am a little better, I am still very unwell – it has taken a lot out of me, lying down,
to write this on my phone. And I know I will feel very unwell after this, and am feeling it
now. But I am writing all this, however horrible it is to talk about, because I want people to
know this is the reality of how M.E can be – that a young woman, who was getting better by
herself with rest, and who had already lost so much, can be pushed into this state by being
told that they should just “push through it”. And I also have Lupus, and the complications
which arise from that.

I have had to have complete bedrest. I have felt so down, and upset, that I am so unwell
again. But I learned a valuable lesson. It was only after I fell ill last month, lying in bed and
not being able to move, that I spent time reading research about M.E on my phone. Before
that, I only really knew about Lupus and didn’t realise the severity of how M.E would affect
me, and more than that; I placed my trust in the professionals and therapists. But now I
know what M.E is, what research has been done into it and what can make M.E worse. I
know there are charities which are fighting for us, I know that there is now new biomedical
research being done in the UK at UCL, and that the PACE trial researchers recently were
ordered by a UK tribunal to release their trial data which they had so far refused to release. I
hope, that in 10 years time and with research that the medical profession can no longer
ignore, the medical guidelines will be changed and such sick people will not be actively
made worse by the very people who are supposed to help them. Any “therapy” that ignores
the serious physical causes and symptoms of M.E, is dangerous.
See also @Dolphin's thread on the PRINCE trial and Rosa ...
http://forums.phoenixrising.me/inde...ptoms-reduction-intervention-cbt-trial.48121/
 
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JohnM

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This raises an interesting question to which someone may know the answer.

An express comment such as that should automatically exclude someone from being consulted as an expert. If NICE nevertheless consider and take into account his/her views do they remain compliant with their regulatory duties? Presumably they cannot select experts on a whim and will have a protocol to follow. Is that protocol in the public domain?
As yet, I can only find the following references in Developing NICE guidelines: the manual as applied to "Expert Witnesses", which seems to term applied to so called (external) Topic Experts that are not on the Topic-Specific Committee?

Perhaps @charles shepherd can confirm my understanding ..

3.5 Other attendees at Committee meetings
Expert witnesses
If the Committee does not have sufficient evidence to make recommendations in a particular area (for example, if there are gaps in the evidence base or subgroups are under-represented), it may call on external experts (expert witnesses) who can provide additional evidence from their experience and specific expertise, to help the Committee to consider and interpret the evidence.

Once the Committee has established that it needs evidence in a particular area from an expert witness, Committee members and NICE’s Public Involvement Programme are asked by the Developer to nominate experts who might fulfil this role. Expert witnesses may also be identified by the Developer or NICE staff with a quality assurance role, or if required, by active recruitment through stakeholder organisations and the NICE website. Experts may be drawn from a wide range of areas as appropriate, including government and policy, research, practice, people using services and carers, or the community and voluntary sector.

Expert witnesses attending a Committee meeting are invited to answer questions from members of the Committee. They may be invited to present their evidence at a Committee meeting in the form of expert testimony based on a written paper .. Expert testimony papers are posted on the NICE website with other sources of evidence when the guideline is published.

Expert witnesses are not members of the Committee; they do not have voting rights, and they should not be involved in the final decisions or influence the wording of recommendations.
All Committee members and anyone who has direct input into the guideline (including the Developer, the evidence review team and expert witnesses) must declare any potential conflicts of interest in line with NICE’s code of practice for declaring and dealing with conflicts of interest .. Any changes to a member’s declaration of interests should be recorded in the minutes of the meeting. Declarations of interests are published with the final guideline.
A quick review of the current NICE Policy on Conflicts of Interest do infer Expert Witnesses are also subject to this policy, and there is to my mind, and as you suggest, a number of potential conflicts at play here; likewise to Topic Committee Members. There was another PR thread dedicated to issues of conflict of interest, but I do not have the time or energy available to find at the mo .. apologies.

Expert Advisors
44. Individuals with specific expertise are routinely invited to attend advisory committee meetings. They provide advice to the committee based on their role and experience. They may or may not work in the NHS and they may or may not have paid employment in health or social care, or in the commercial sector.

45. External experts will be asked to declare their interests at the point they are invited to give evidence. Every effort will be made to select experts who do not have a conflict of interest of a kind which would require a member
of the committee to withdraw from the discussion, However, the relevant NICE Director has discretion to invite an expert with such a conflict where he or she is the only source of advice available and the work of the committee would be seriously compromised without their testimony.
Hope the above helps, and wishing everyone improved health and every happiness. John
 

user9876

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If Rituximab is shown to work in ME then the BPS group will focus their efforts on two areas:
1. They will say there is not enough evidence yet, all the studies are from one group of researchers, there need to be more patients treated, there needs to be long-term follow up first.
2. They will claim Rituximab is not safe and will try and blow the realities here completely out of proportion. They have the SMC and other influencers and will try to scare everyone over it.

I think we need to start thinking about this now because they will fight hard to hold it up in these ways and we need to be prepared for that. I don't know the history of RA but I imagine they will be able to hold up Rituximab's approval in ME much longer.
Those experts who failed to mention it in their evidence will look pretty silly to NICE and tend to discredit themselves. In that when NICE do this they seem completely unaware they should look at the experts and teams who failed to pick up on the possibilities and ask about their competence.
 

Esther12

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I can't open the files. What type of document are they? I also don't have any reading energy right now...
They're pdfs. Anyone else having trouble?

Is there any reason to avoid speculating about these 'experts' identities? We know that QMUL have tried to take out of context quotes from PR to excuse their refusals to release infomation. Worth some caution?

Having said that, expert 6 reminds me of this puported quote from a guy who was on the NICE CFS panel last time:

Grunewald continued: “When the NICE Guidelines are published I hope this will be the beginning of a sea change. ME is always the result of stress. The way that has been found most effective is to address this with a multi-disciplinary approach including graded activity programmes and addressing psychological issues. Some models (of ME/CFS) are unhelpful such as the virus model. There doesn’t seem to be any doubt that for the majority of people there is not a viral trigger”
http://forums.phoenixrising.me/inde...-no-review-considered-necessary.52648/page-11
 
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Orla

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This comment from number 6

“I am suspect [sic] that there is a tendency in the USA to push towards an entirely biological explanation for the condition, whereas in the UK there is an increasing acceptance amongst patients and clinicians alike of a model that includes CFS/ME in the umbrella of functional neurological disorders, i.e. that it is an emotionally driven disorder.”

reminds me of this

"Functional symptoms are complaints that are not primarily explained based on physical or physiological abnormalities. They are likely to have an emotional basis. They may mimic neurological disorders."

from the draft guideline for suspected neurological conditions http://www.meassociation.org.uk/201...ed-neurological-conditions-11-september-2017/
 

Starlight

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I can't open the files either.Im glad of all the comments so that I can get a fair idea. The so called experts who are willing to become involved without having real knowledge of ME CFS is alarming to me as their opinions carry so much weight with regard to the treatments advised for patients.i had thought there would be much more care and professionalism demanded for being part of a decision making process for people who are ill, many for many long years. Would the decision making processes for other diseases be more rigorous?. What is being accepted by Nice here seems very lax to me. Will they ever surprise us in any kind of a positive way.?
 

anniekim

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Disturbing reading.

Whoever #6 is, we know that the person is someone with a hard on for the umbrella term somatic functional disorders, this also precludes the person from being someone like White, who has been critical of somatic functional disorders in the past.

My guess would be someone like Wessely, Nimnuan or Sharpe.



So we can rule out Sharpe as well I guess.
Jon Stone?
 

AndyPR

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Guiding the lifeboats to safer waters.
It would be good, though I'm not volunteering myself, if the files could be uploaded elsewhere also as people directed here I believe won't be able to see the attachments unless they join.
This thread isn't in the Members Only section so the files and all posts should be visible to all.

To view the files, as they are PDFs, if you are using a desktop or laptop, you will need Adobe Reader. Most computers will come with this automatically nowadays I believe, otherwise it can be downloaded for free from https://get.adobe.com/uk/reader/otherversions/ (if not in the UK, select your region with the button at bottom left of the webpage). If you are using a phone or tablet unfortunately I don't have the experience to advise on how to view them but would suggest Googling something like "how to view PDF files [name of your device]".
 

Dolphin

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Just to point out to anybody interested that two papers have been published by researchers on the outcomes from the CFS/ME clinics in England and the results have not been good:

BMC Health Serv Res. 2017 Jul 14;17(1):488. doi: 10.1186/s12913-017-2437-3.
Specialist treatment of chronic fatigue syndrome/ME: a cohort study among adult patients in England.
Collin SM1, Crawley E2.

https://www.ncbi.nlm.nih.gov/pubmed/28709432



Treatment outcome in adults with chronic fatigue syndrome: a prospective study in England based on the CFS/ME National Outcomes Database.
Crawley E1, Collin SM, White PD, Rimes K, Sterne JA, May MT; CFS/ME National Outcomes Database.

https://www.ncbi.nlm.nih.gov/pubmed/23538643
 
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