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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
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]
