NICE shows transparency, releases documents ahead of 18 October roundtable + a note on parliamentary activity

Disclosure: I have lived with the discrete illness myalgic encephalomyelitis (ME) since 1981. I have written extensively about the current NICE process (amongst other topics) in relation to this illness. I am a barrister. For more information see About.

I work independently and I am not affiliated to any organisation or group in the ME community. 

FOR NEW READERS: there is a summary of the background to this post in my previous post here. 

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News release

On 12 October, the National Institute for Health and Care Excellence (NICE) issued a news release providing some further information about the roundtable event on 18 October. This meeting has been arranged to address matters arising from the “paused” publication of the new guideline for the diagnosis and management of “ME/CFS”.

The latest news release can be read here. It confirmed Dame Carol Black as the “independent” chair for the meeting, named Dr Paul Chrisp and Dr Peter Barry as presenters and set out a skeleton agenda. 

Two new project documents

On 13 October, NICE followed this up with two more documents under a new heading of “Stakeholder Workshop”.

The first document sets out the discussion points for the meeting as follows:

ME/CFS Summary of issues
The following list is a summary of key themes that have been raised by stakeholders
regarding the content of the pre-publication version of the ME/CFS guideline.
1) Diagnosis – Questions have been raised regarding the diagnostic criteria that
the committee have recommended.
2) Children and young people – There is concern that the recommendations
potentially create risks for children and young people with ME/CFS.
3) Graded Exercise Therapy (GET) – There are questions about the
recommendation not to offer programmes that use fixed incremental
increases in physical activity or exercise, for example GET. In particular the
definition of GET, that positive evidence for GET has been downgraded, and
removing GET as a treatment option may lead to a reduction in services
overall
4) Cognitive behavioural therapy (CBT) – There are questions about the place
of CBT in individualised management. In particular that there is positive
evidence which has been downgraded, and that the guideline downplays the
effectiveness of CBT.
5) Methodological approach – There are questions about the approach taken
to the evidence, with suggestions that studies have been inappropriately
excluded or downgraded.

Whilst none of these topics contain any great surprises for anyone who has been following this process, these are all highly contentious areas. The fact that they are up for discussion is of great concern to many in the international ME community. 

The second document sets out the practicalities of the meeting – date, time, location etc. What is new, however, is the list of attendees which has previously been kept secret. 

External attendees:
25% M.E. Group
Academy of Medical Royal Colleges
Action for ME
British Association for CFS/ME
Chartered Society of Physiotherapy
Forward-M.E.
#ME Action
The ME Association
ME Research UK
The ME Trust
NHS England & NHS Improvement
Royal College of General Practitioners
Royal College of Occupational Therapists
Royal College of Paediatrics and Child Health
Royal College of Physicians
Royal College of Psychiatrists
Science for ME
Tymes Trust

NICE & Guideline developer attendees:
Gillian Leng Chief Executive
Paul Chrisp Director, Centre for Guidelines
Christine Carson Programme Director, Centre for Guidelines
Peter Barry ME/CFS Guideline Chair
Ilora Finlay ME/CFS Guideline Vice Chair
Kate Kelley Developer Guideline Lead
Philip Alderson Clinical Adviser
Toni Tan Technical Adviser
Rupert Franklin Senior Guideline Commissioning Manager
Rebecca Smith Associate Director External Communications
Helen Finn Senior Communications Manager
Philip Ranson Media Relations Manager

The second page of this document gives the meeting’s objectives and a more detailed version of the agenda. 

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Comment

This further information from NICE is most welcome. However, the reasoning behind the decision to “pause” publication of the new, final guideline is still concerning. As I said in my previous post: 

If [NICE] intends to publish the new guideline regardless of the outcome of the roundtable, then there is no justifiable reason why full publication has not already taken place.

However, if NICE has not yet published the guideline on the basis that there might be some changes or tweaks as a result of the roundtable event, then this either reopens a process which has already been completed or it begins a whole new consultation and evidence review.

There is no credible justification for those options. If either was to happen, it would confirm that this process is fundamentally and irretrievably flawed.

Due process

On the one hand, NICE must be held accountable for its extraordinary recent actions – hence the ongoing pre-action for a judicial review of the decision to pause publication. The new guideline must be published in order to replace the dangerously out-of-date 2007 guideline which remains operational until the new one is published. 

On the other hand, the new guideline itself, whilst an improvement on the 2007 version, is still dangerously flawed. The draft guideline from November 2020 (72 pages) was far more acceptable to most members of the international ME patient community. This final version (83 pages) has significantly diluted and reconfigured the draft version, thereby increasing the risk of serious harm to patients.

Looking at it again, my assessment of the new guideline from an earlier post in this series still stands (notwithstanding the herculean efforts of all those involved in producing it over the last four years): 

It’s rubbish. It still contains far too much latitude for abuse of patients. However, it is less rubbish than the existing guideline from 2007. It is a significant improvement on that and it is the best we are going to get for the foreseeable future. 

Accessing the final version of the new guideline document 

The unpublished final guideline remains confidential, according to NICE. However, I have disputed this claim in an earlier post. Anyone who has not yet seen this new version and wishes to do so can access it via another post on this blog where I have made it available.

To download the final, unpublished guideline, go to this post here and scroll down towards the end of the post. You will see a link from which the document can be downloaded. 

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A NOTE on parliamentary questions and government intervention in the NICE process

There have been six written questions in the House of Commons on this topic recently and oral questions in the House of Lords on 12 October 2021. Neither has proved particularly illuminating. 

Whilst NICE is ultimately accountable to the Department of Health and Social Care, its status as an independent executive non-departmental public body means that government intervention is unlikely. MP’s can lobby for individual causes (eg. as in the questions above) but their powers are limited. 

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