S4ME Letter to Nice Concerning Chris Burton

Science For ME · Jan 21, 2019

This is a letter we sent from S4ME to NICE as discussed in a voting thread for those members who have posted enough to have voting rights.

Sorry I forgot to post it here earlier

To Peter Barry (chair NICE ME/CFS GDG) and David Coombs (Associate Director in charge of complaints)

Re: Appointment of Prof Chris Burton to the ME/CFS Guideline Committee

Science for ME is an online forum with over 1000 members internationally, including people with ME, their carers and supporters including scientists. We are a stakeholder for the NICE ME/CFS guideline.

We wish to draw to the attention of those responsible for appointing the members of the NICE ME/CFS Guideline committee, and to the chair of that committee, the following concerns.

Conflicts of Interest:

1. Prof Burton's current allegiance to specific trial methodologies as conflict of interest
NICE’s policy on managing interests for its advisory committees states that an individual may have a direct non-financial professional or personal interest if they have a benefit such as ‘increasing or maintaining their professional reputation.’[1]

Prof Burton will, during the time the committee is operating, be acting as Chief Investigator on a medically unexplained symptoms (MUS) clinical intervention trial 'Multiple Symptoms Study 3’ (MSS3) [2]

Prof Burton’s trial uses the same flawed methodology as trials of CBT and GET that will be under consideration by the Committee, which have been challenged as scientifically unsound in peer reviewed articles and two recent psychology textbooks [3,4,5]. The most serious flaw common to all these trials, which invalidates their conclusions, is that they are both unblinded and use subjective primary outcome measures [6]. This fundamental flaw is made even more grievous by the fact the interventions evaluated involve persuading patients to interpret differently the very symptoms and functions being assessed in outcome questionnaires.

Asking Prof Burton to take a scientific and unbiased view of the evidence presented to the Committee regarding the fatal flaws in PACE and other similar trials, is asking him to acknowledge his own research methodology as fundamentally unsound, thereby injuring his own professional reputation. We therefore ask that NICE evaluate the propriety of Prof Burton’s involvement in consideration of treatment trials for ME/CFS, and advising, developing recommendations and decision-making on them.

2. Prof Burton’s MSS3 trial intervention as conflict of interest

NICE’s policy on managing interests for its advisory committees states that an individual may have a direct non-financial professional or personal interest if they are ‘actively involved in an ongoing or scheduled trial or research project aimed at determining the effectiveness of a matter under review.’ [1]

As explained above, Prof Burton will lead the MSS3 clinical trial during the time the Committee is operating. According to the MSS3 trial protocol (v.2.0), patients with persistent (medically unexplained) symptoms are recruited whose GP records include at least one record for a ‘MUS syndrome’.[7] In the protocol, ‘chronic fatigue’ is described as a MUS syndrome and set in context with other syndromes. Version 2.0 of the trial protocol (dated 20th August 2018) documents removal of the word ‘syndrome’ from the term ‘chronic fatigue syndrome’ to ‘more accurately reflect the inclusion criteria.’ Prof Burton has previously written of ‘chronic fatigue’ as a syndrome [8,9,10] and described ‘chronic fatigue’ and CFS as MUS syndromes [8,11,12,13].

This conflation of chronic fatigue and CFS is also revealed when comparing inclusion criteria for a recent trial of multiple medically unexplained symptoms co-authored by Prof Burton with that for the MSS3 trial. Patients with CFS were eligible for trial entry in the former [12]; patients with a ‘chronic fatigue’ syndrome are eligible in the latter [7]. Therefore, it seems ME/CFS patients are eligible for trial entry and likely to be under study in the MSS3 trial.

The MSS3 trial intervention includes ‘cognitive and behavioural techniques’ and ‘rational explanations’ of medically unexplained symptoms [7]. Prof Burton’s participation in deliberations on any aspect of the guideline that could reasonably be considered to form part of the intervention under study in the MSS3 trial – including CBT and explanations of ME/CFS of the sort employed in the trial intervention – would represent a conflict of interest. We therefore ask that NICE evaluate the propriety of Prof Burton’s involvement in consideration of these topics, and advising, developing recommendations and decision-making on them.

3. Medically unexplained symptoms as potential conflict of interest

NICE’s policy on managing interests for its advisory committees, states that an individual may have a direct non-financial professional or personal interest if they have ‘published a clear opinion about the matter under consideration.’[1]

As explained above, in previous publications and research, Prof Burton has included CFS as a MUS syndrome, and has published extensively on MUS and allied terms (including ‘persistent physical symptoms’ and ‘medically unexplained physical symptoms’). He was editor of and co-contributor to the book ABC of Medically Unexplained Symptoms, which includes a dedicated chapter on fatigue and CFS/ME.[11] By ‘medically unexplained symptoms’, Prof Burton does not simply mean symptoms that are not yet diagnosed. He has published the view that it is ‘now possible to explain persistent physical symptoms using models such as central sensitisation’[7,14] and suggested that severe MUS may be classifiable as the mental health disorders, bodily distress syndrome and somatic symptom disorder [7,14,15]. He has published views on the underlying causation, explanations, treatment of and referral strategies for ‘MUS’[7,10-14,16-18].

We therefore assert that Prof Burton has published a clear opinion that CFS is a MUS syndrome, and that he has published clear opinions on causation, explanations and management of MUS. Should the specific topic of MUS (or its allied concept terms) arise in the course of any element of the guideline review (including but not limited to diagnosis, explanations, management, or referral), Prof Burton’s participation on this topic may constitute a conflict of interest. We therefore ask that NICE evaluate the propriety of Prof Burton’s involvement in consideration of medically unexplained symptoms (should it arise in the course of the Committee’s deliberations) and advising, developing recommendations and decision-making on that topic.

Medically unexplained symptoms: Unsuitability of Prof Burton as Committee appointee

Prof Burton appears to regard ‘rational explanations’ of MUS and cognitive behavioural techniques to be potentially viable interventions for all ‘MUS’ syndromes [7,10,12,16,18], despite the heterogeneity of conditions such a group represents. Undiscriminating condition management of this sort increases the risk of iatrogenic harm for all patients concerned. However, given ME/CFS patients are particularly vulnerable to deterioration due to the characteristic symptom, post-exertional malaise, they are put notably at risk. He has expressed the view that repeat investigation for ‘patients with MUS’are unlikely to bear fruit [19] and has published to the effect MUS syndromes may be managed with a Symptoms Clinic Intervention delivered by GPs (this is currently under study in the MSS3 trial) [7,12,18]. Due to condition severity, it is often difficult for ME/CFS patients to achieve investigation of new or worsening symptoms, which may be indicative of a new or missed diagnosis and ought to be properly explored. The bar to access specialist care should not be further raised by the inappropriate framing of ME/CFS as MUS.[20]

Our Questions:

We understand that NICE’s processes may not permit you to comment specifically about Prof Burton. However, in light of the above, we would appreciate if you would answer the following questions.

1. In its response to patient concerns about the make-up of the Committee, NICE has stated that, ‘interests the members have declared’ can be managed using NICE’s conflicts of interest policy. Will NICE take into account and appropriately manage interests that members themselves fail to declare but that have been called to NICE’s attention by stakeholders and others?

2. In accordance with NICE’s policy on managing interests, to what extent will NICE exclude a committee member who has the following interests:

a. Is leading an ongoing clinical trial that uses the same flawed methodology that was used in many of the trials that will be under consideration by the Committee.
b. Is leading an ongoing clinical trial that may include CFS patients, in which the intervention incorporates issues that will be under consideration by the Committee (ie., CBT and explanations of ME/CFS).
c. Has published a clear opinion that CFS is a MUS syndrome and clear views on causation, management and referral strategies for MUS (in the event MUS or its allied concept terms arise in the course of the Committee’s deliberations).

3. If a committee member’s research and publications suggest that they do not regard ME/CFS to be a separate clinical entity from other ‘medically unexplained symptoms’, with different attendant treatment needs, does NICE nonetheless consider that member suitable to serve on NICE’s ME/CFS Guideline Committee?

4. NICE’s policy on managing interests states, ‘A written audit trail is maintained of the information considered and any actions taken.’ [1] Will stakeholders as a matter of course or by request be provided with a copy of NICE's audit trail?

Thank you for your attention to these matters, which are of serious concern to the entire ME/CFS community.

Thanks

Science For ME Forum

In addition the Sheffield ME and Fibromyalga Group has asked us to add their support to this letter:

The Sheffield ME and Fibromyalga Group is a local charity to provide mutual support for sufferers of ME and Fibromyalgia and to raise awareness about the conditions and their impact. We are extremely concerned to find that our local Professor Chris Burton has been appointed to the NICE Guidelines Development Group to review the diagnosis and treatment of ME/CFS. Our group supports S4ME in asking these questions and cannot support the appointment of Prof Burton until action is taken to address the issues raised.

Sheffield ME and Fibromyalgia Group

References:

[1] NICE Policy on declaring and managing interests for NICE advisory committees (April 2018)

[2] Multiple Symptoms Study 3. ISRCTN Registry ISRCTN57050216 doi.org/10.1186/ISRCTN57050216

[3] Special Issue: The PACE Trial. (August 2017) J Health Psychol 22(9)

[4] Marks, D et al., Health Psychology: Theory, Research and Practice (2018) 5th ed, SAGE Publications Ltd

[5] Hughes, B Psychology in Crisis (2018) 1st ed, Red Globe Press

[6] Edwards, J PACE team response shows a disregard for the principles of science (2017) 22(9)9: 1155-1158 https://doi.org/10.1177/1359105317700886

[7] Multiple Symptoms Study 3: pragmatic trial of a community based clinic for patients with persistent (medically unexplained) physical symptoms, Research Protocol v.2.0 20 August 2018 [PDF]: http://www.isrctn.com/editorial/retrieveFile/6b3d6b51-92b3-4825-89a8-9060bf0da471/35773

[8] Burton, C., Can we explain medically unexplained symptoms? Fam Pract1 Dec 2014 31:6 PP 623–624, https://doi.org/10.1093/fampra/cmu067

[9] Rief W, Burton C, et al., Core Outcome Domains for Clinical Trials on Somatic Symptom Disorder, Bodily Distress Disorder, and Functional Somatic Syndromes: European Network on Somatic Symptom Disorders Recommendations (2017) Psychosom Med 79(9):1008-1015. doi: 10.1097/PSY.0000000000000502

[10] Burton C, Recognising and managing “medically unexplained” physical symptoms (Sept 2016) Scottish School of Primary Care GP Clusters Briefing Paper 4

[11] Burton C (editor and contributor) ABC of Medically Unexplained Symptoms: BMJ Books. Wiley-Blackwell 2013 ISBN-10: 9781119967255

[12] Morton L, Elliott A, Thomas R, Cleland J, Deary V, Burton C, Developmental study of treatment fidelity, safety and acceptability of a Symptoms Clinic intervention delivered by General Practitioners to patients with multiple medically unexplained symptoms. (2016) J Psychosom Res. 84:37-43. doi: 10.1016/j.jpsychores.2016.03.008

[13] Hartman T, Rosendal M, Aamland A, van der Horst H, Rosmalen J, Burton C, Lucassen J What do guidelines and systematic reviews tell us about the management of medically unexplained symptoms in primary care? (2017) BJGP Open 1(3): BJGP-2016-0868. doi: https://doi.org/10.3399/bjgpopen17X10106

[14] Rosendal, M "Medically unexplained" symptoms and symptom disorders in primary care: prognosis-based recognition and classification, Burton, 2017
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297117/

[15] Chowdhury, S, Burton, C. Associations of treatment effects between follow-up times and between outcome domains in interventions for somatoform disorders: Review of three Cochrane reviews. (2017) J Psychosom Res 98: 10-18 doi: 10.1016/j.jpsychores.2017.04.013

[16] Burton, C Explaining symptoms after negative tests: towards a rational explanation (2015) J Roy Soc Med, 108(3): 84-88 doi: 10.1177/0141076814559082

[17] Morton, L, Elliott, A, Cleland, J, Deary V, Burton, C. A taxonomy of explanations in a general practitioner clinic for patients with persistent “medically unexplained” physical symptoms. ((2017) doi:10.1016/j.pec.2016.08.015

[18] den Boeft M, Huisman D, Morton L, Lucassen P, van der Wouden JC, Westerman MJ, van der Horst HE, Burton CD. Negotiating explanations: doctor-patient communication with patients with medically unexplained symptoms-a qualitative analysis. (2017) Fam Pract. 34(1):107-113. doi: 10.1093/fampra/cmw113

[19] Burton C, Healthcare costs incurred by patients repeatedly referred to secondary medical care with medically unexplained symptoms: a cost of illness study. (2012) J Psychosom Res. 72(3):242-7. doi:10.1016/j.jpsychores.2011.12.009

[20] Sunnquist, M Access to Medical Care for Individuals with Myalgic Encephalomyelitis and Chronic Fatigue Syndrome: A Call for Centers of Excellence. (2017) Mod Clin Med Res 1(1): 28–35 doi: [10.22606/mcmr.2017.11005]
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Science For ME · Jan 21, 2019

Reply from Peter Barry

Dear S4ME,

Thank you for your email, and for bringing this matter to my attention

I note that you have sent this to the Corporate team who are responsible for handling complaints at NICE. I am sorry, but I cannot therefore comment any further.

I would, however, repeat my previous reply to you that all issues around declarations and conflicts of interest will be handled in accordance with the NICE ‘Policy on declaring and managing interests for NICE advisory committees’.

Please do feel free to contact me with any further concerns. I might not be able to reply, but I will note what you say.

With best wishes

Peter Barry
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Binkie4 · Feb 5, 2019

MODS- am unsure if I am posting this on the right thread. Please move to another thread if more appropriate.

Our MP (Sir Edward Davey- libdem) has been very supportive of our concerns about fairness in the composition of the Nice Guidelines Development Group. When we wrote a detailed letter to Nice and received only a template response, we sought his help and he wrote to Sir Andrew on our behalf. This is the response he received from Sir Andrew.

“Dear Mr Davey,

Thank you for your email.

I am aware that people living with ME/CFS are concerned about the appointments we have made to our guideline committee. Because of this concern, I have reviewed the membership and it has also been considered by the Senior Management Team at NICE. This unusual level scrutiny is an indication of the importance we attach to ensuring that we have a balanced committee in what I acknowledge is a contentious area. We have been careful to appoint to the committee, through open advertisement, people who hold different views about the possible causes and treatment for the condition, together with those who have not expressed a particular position. We expect them all to consider the evidence objectively and to consider carefully and respectfully the views put forward by their fellow members and the patient and clinical experts who have been invited to speak to them.

I prepared the response to those to those who have written to NICE on this matter and which you have seen. I’m afraid that I’m not in a position to add to what I have said in that response. We need to give the committee the chance to demonstrate that it can consider the written and oral evidence in accordance with our published methods, consult with a genuine intention of responding to reasoned argument and then formulate recommendations that accurately reflect what we know about the condition and the treatments that can really make a difference to the people living with it.

Yours sincerely,

Andrew Dillon
Chief Executive
National Institute for Health and Care Excellence
10 Spring Gardens | London | SW1A 2BU | United Kingdom”

I am glad the Committee received “ unusual level scrutiny” by the Senior Management Team and Sir Andrew personally at Nice, and I hope they continue to do this in appointing the last ?3 members.

Sir Andrew states that the Group will “ consult with a genuine intention of responding to reasoned argument and then formulate recommendations that accurately reflect what we know about the condition and the treatments that can really make a difference to the people living with it.”

But the accepted ( emphasis on accepted) body of knowledge and treatments is with the discredited BPS school.

How is sense to come from this? What is accepted as known about the condition and the treatments provided is based on rubbish research. How is it going to play out?

Snowdrop · Feb 5, 2019

Is there any good research on treatments that are symptomatic relief for some of the symptoms we experience? Perhaps those could be used as evidence.

Jonathan Edwards · Feb 5, 2019

Binkie4 said: ↑

How is sense to come from this? What is accepted as known about the condition and the treatments provided is based on rubbish research. How is it going to play out?
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I think everyone involved in this is aware that nothing is now accepted. The committee has to start afresh and look at the evidence. Received wisdom has no authority. Since something near half of the committee are sceptical about the evidence for anything much I cannot see how anyone can push anything through without the evidence being presented and minuted in a public document.

Sir Andrew says nothing about accepted evidence or what is accepted as known. If the received wisdom was considered adequate then there would never have been a review of the guidelines.

Jonathan Edwards · Feb 5, 2019

Snowdrop said: ↑

Is there any good research on treatments that are symptomatic relief for some of the symptoms we experience? Perhaps those could be used as evidence.
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I think the general view is that symptomatic treatments follow general principles that do not relate specifically to ME so nothing specific needs to be put in an ME guideline.

If there is no evidence that is not a problem. The conclusion has to be that there is no evidence. That would not be in any way unusual.

Binkie4 · Feb 5, 2019

I very much hope the whole Committee will start afresh and look at all the evidence including the harms perpetrated by GET, Workwell’s evidence etc but will this be the case? It’s not so long since Nice were saying they couldn’t consider evidence from outside the U.K. I’m pretty sure there is a statement somewhere that makes clear that is no longer the case.

But I am concerned about what has happened with Cochrane. It is all taking so long to make utterly clear what the status of the Cochrane review is.

And some of the comments on another thread about “ behind the scenes” influence are not comforting.

https://www.s4me.info/threads/nice-guidelines-topic-experts-and-the-behind-the-scenes.7985/

It isn’t hard to sometimes be positive but I find it hard to remain totally positive. Obviously I need even more CBT.

Esther12 · Feb 6, 2019

The fact that they appointed someone like Chris Burton, even after applying an "unusual level scrutiny", shows how broken the system is, and how desperately we need a more fundamental change to the way NICE works.

"We expect them all to consider the evidence objectively and to consider carefully and respectfully the views put forward by their fellow members and the patient and clinical experts who have been invited to speak to them."

Why are they foolish enough to expect that? They've included a PACE trial author, after seeing how the PACE authors examine the evidence and respond to the views of others.

"We need to give the committee the chance to demonstrate that it can consider the written and oral evidence in accordance with our published methods, consult with a genuine intention of responding to reasoned argument and then formulate recommendations that accurately reflect what we know about the condition and the treatments that can really make a difference to the people living with it."

I don't think we do need to give this committee that chance, but if they are given a chance and fail, what then?

Science For ME · Mar 24, 2019

We had a further response on this and I think its also useful to look at the response we had to taking the first letter to the NICE complaints review process which is here:
https://www.s4me.info/threads/s4me-...have-a-conflict-of-interest.6994/#post-154448
The response basically says they followed due process in reviewing conflicts of interest and I don't think the case would be considered differently here. The complaints process seems to check how they acted rather than the details.

Dear Science for ME

Thank you for your email to Peter Barry (Chair of the ME/CFS Guideline Development Group) and David Coombs (Associate Director in charge of complaints). I am very sorry for the delay in responding to your email, unfortunately we have been experiencing a higher than usual volume of enquiries which has affected our usual response times.

Your questions are about how interests will be managed during development of the guideline and we don’t consider them a complaint under our policy. We can’t comment on the specific issues you have raised about Professor Burton but I have answered each of your more general questions below.

In its response to patient concerns about the make-up of the Committee, NICE has stated that, ‘interests the members have declared’ can be managed using NICE’s conflicts of interest policy. Will NICE take into account and appropriately manage interests that members themselves fail to declare but that have been called to NICE’s attention by stakeholders and others?

Committee members are expected to declare interests if, in the view of a reasonable person, they are relevant, or could be perceived to be relevant, to the work of the NICE committee in question.

Under the policy on declaring and managing interests for NICE advisory committees, an interest that has not been declared is referred to as ‘a breach’ of the policy. We will take into account and appropriately manage any breaches according to their specific facts and merits. You can read more in the policy document.

In accordance with NICE’s policy on managing interests, to what extent will NICE exclude a committee member who has the following interests:
a. Is leading an ongoing clinical trial that uses the same flawed methodology that was used in many of the trials that will be under consideration by the Committee.
b. Is leading an ongoing clinical trial that may include CFS patients, in which the intervention incorporates issues that will be under consideration by the Committee (ie., CBT and explanations of ME/CFS).
c. Has published a clear opinion that CFS is a MUS syndrome and clear views on causation, management and referral strategies for MUS (in the event MUS or its allied concept terms arise in the course of the Committee’s deliberations).

Scenarios like these will be managed by the committee chair or vice-chair in accordance with the policy.

If a committee member’s research and publications suggest that they do not regard ME/CFS to be a separate clinical entity from other ‘medically unexplained symptoms’, with different attendant treatment needs, does NICE nonetheless consider that

member suitable to serve on NICE’s ME/CFS Guideline Committee?

As might be expected, a number of committee members have expressed a range of views on the nature and causation of ME/CFS. This will be managed by the chair or vice-chair in accordance with the policy.

4. NICE’s policy on managing interests states, ‘A written audit trail is maintained of the information considered and any actions taken.’ [1] Will stakeholders as a matter of course or by request be provided with a copy of NICE's audit trail?
NICE routinely publishes the register of declared interests and any actions taken on the website. The register for this guideline will be published on the project documents page for this guideline soon. Interests are declared and managed at each committee meeting and this is recorded in the minutes which are also published on the website.

I hope this helps explain the importance NICE places on managing interests appropriately and how we go about doing this.

Please tell us how we did by completing our short survey. It will only take you a couple of minutes.

Kind regards

Helen

Helen Finn

Senior Communications Manager (Enquiries)

National Institute for Health and Care Excellence
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Dolphin · Jun 18, 2019

I wasn't sure which thread to post this to. Chris Burton has written a chapter in a medical textbook
Persistent Physical Symptoms and Symptoms Without Apparent Disease

A lot of it can be read here:
https://books.google.ie/books?hl=en...=onepage&q="chronic fatigue syndrome"&f=false

rvallee · Jun 18, 2019

Dolphin said: ↑

I wasn't sure which thread to post this to. Chris Burton has written a chapter in a medical textbook
Persistent Physical Symptoms and Symptoms Without Apparent Disease

A lot of it can be read here:
https://books.google.ie/books?hl=en&lr=lang_en&id=Y9KcDwAAQBAJ&oi=fnd&pg=PA426&dq="chronic+fatigue+syndrome"&ots=nnXYfamoXV&sig=TApYPTmIm2g5-XPYzXqK7V_mTFU&redir_esc=y#v=onepage&q="chronic fatigue syndrome"&f=false
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"Apparent disease" is doing a lot of work here. Literally the same basis for labeling peptic ulcers psychosomatic. And the same thinking behind the initial rejection of the germ theory of disease. Also the god of the gaps: if I can't see it it doesn't exist and therefore it must be what I personally believe it to be.

Everything is not apparent until it is. This take is so lazy it developed bed sores. At some point it has to be considered violence to systematically refuse to properly fund research then turn around and promote wild-ass nonsense alternative assumptions as the best explanation we have because we haven't yet figured it out by underfunding the search for a solution. The result is death and suffering for tens of millions, after all. If that's not violence then we're using a different definition.

Trish · Dec 20, 2022

Attention has been drawn back to this because Burton et al have published the protocol for their trial referred to in our letter, see this thread:
https://www.s4me.info/threads/unite...-mus-treatment-trial.18696/page-2#post-447008
To discuss the trial, go to that thread.

I have raised it here because we were reassured conflicts of interest would be taken into account in who was allowed to contribute to parts of the guideline writing process. I'm wondering whether any of the COI's we raised were considered, specifically whether Burton was excluded from decisions relating to research methodology and the definition of ME/CFS and its relationship to 'MUS'. @adambeyoncelowe

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