Update on the “paused” NICE guideline for “ME/CFS”: the case for individual/community publication.
Disclosure: I have lived with the discrete illness myalgic encephalomyelitis since 1981. I have written extensively about the NICE process (amongst other topics) in relation to this illness. I work independently and I am not affiliated to any organisation or group in the ME community. For more information see About.
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This post follows on from my previous one on this topic, dated 20 August 2021 (see here). For the full story so far, please refer to that post.
Summary for new readers
In 2017, the English National Institute for Health and Care Excellence (NICE) began the process of updating the dangerously out-of-date guideline for “ME/CFS” (myalgic encephalomyelitis/chronic fatigue syndrome), originally published in 2007. This guideline recommended treatments which many patients have long found to be actively harmful.
After several delays, the draft guideline was published on 10 November 2020. 
This draft removed/downgraded the most harmful treatments from its recommendations and, as such, was broadly welcomed by the patient community. On 4 August 2021, the new guideline, marked “FINAL“, was circulated to stakeholders who had commented on the draft version.
By this stage, the guideline committee had approved this final version and, according to the NICE manual, the NICE Guidance Executive would now have signed it off. The fact that it was then circulated to stakeholders indicated that the process was now closed and completed.
According to NICE’s “Main stages of guideline development“, the publication stage began at this point. Publication to the world at large was scheduled for 14 days later, on 18 August. The document was to remain confidential until then.
Just after 3pm on 17 August, less than 9 hours before the scheduled time for general publication of the new guideline, NICE notified stakeholders that it was “pausing” publication. By this stage, only exceptional circumstances could have derailed the process. Thus far, NICE has failed to provide evidence of any such circumstances.
The current position
If NICE is planning to open up a new consultation process on its guideline for “ME/CFS” then it must clarify its position immediately and communicate this with full transparency to stakeholders and the general public. If NICE fails to provide this information, then this amounts to a breach of its duty to properly exercise its statutory functions.
If there is no proposed plan, then NICE should publish the new guideline of its own volition without further delay.
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Individual publication of the new guideline
Following my previous post, a number of people contacted me. I now have a copy of the guideline.
The main risk in publishing would be borne by me as the publisher and I am willing to take that risk. However, understandable individual concerns have been expressed by others.
I am not prepared to publish it here without the full agreement of all parties involved so I will not proceed for the time being.
[Edited to add: no one is preventing me from publishing. However, whilst I can manage risk on my own behalf, I cannot breach the trust of anyone who might provide information in confidence but then has legitimate concerns about proceeding with my publishing it. In any event, community publication would have much more impact.]
My assessment of the guideline
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.
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- Purpose:
To provide essential information to the public about the guideline as it stood on 17 August 2021 and as a comparator with any future versions of the new guideline. - De facto publication:
The new guideline document has already been distributed, officially and unofficially, to a large number of recipients via 280 stakeholder groups and multiple media leaks therefore de facto publication has already occurred. - Public domain:
Information about the contents of the document has been in the public domain since 17 August via various media reports. That information is not inherently secret. - Confidentiality expired:
The confidential nature of the document expired at 12.01am on 18 August. This, combined with the de facto publication, means that the document has lost its “quality of confidence”. - Public health considerations:
The process of updating the guideline has been delayed several times. NICE has been on notice since April 2019 that patients may be experiencing harm from treatments recommended in the 2007 guideline. That guideline remains operative until NICE publishes the new version. The public health considerations and potential liability issues raised by this further delay militate strongly in favour of immediate publication. - Delaying publication without clear justification is an unlawful action:
Millions of members of the international ME community have been waiting years for this new guideline. Delaying publication further without reasonable justification and in apparent contravention of NICE’s own Guidance Development Manual would be unlawful. NICE has a wide discretion in the way it conducts its affairs but credible reasons for the delay have not been forthcoming.
In all the circumstances, the arguments for publication demonstrate that there is an overwhelming public interest in favour of publishing the guideline.
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Trackbacks
- More reactions to NICE – Life with ME by Sissel
- NICE has “paused” the release of the revised Guideline on ME/CFS | On Eagles Wings
- A debt of gratitude | valerieeliotsmith
- Legal opinion and legal advice: the “paused” NICE guideline for “ME/CFS” | valerieeliotsmith
- Uitstel van levensbelangrijke besluiten
- Abuse of process & abuse of power: a NICE publication (with file download) | valerieeliotsmith
- What’s wrong with the NICE process + what can be done about it? | valerieeliotsmith
- NICE developments: preparatory action for a judicial review of the decision to pause publication of the new guideline for “ME/CFS” | valerieeliotsmith
- NICE shows transparency, releases documents ahead of 18 October roundtable + a note on parliamentary activity | valerieeliotsmith
- NICE publishes updated guideline for “ME/CFS” | valerieeliotsmith
- FOI requests reveal that NICE caved in response to threats from psychiatric lobby in “ME/CFS” debacle | valerieeliotsmith
- 🌍 Much ado about a lot
- Complaint dismissed: a charitable error or failure of due process? | valerieeliotsmith
- Governance under scrutiny: identities revealed in charity complaint | valerieeliotsmith
valerieeliotsmith 
Thank you for giving us your thoughts Valerie. They are always valuable.
I wonder whether, in light of NICE’s failure to publish the final version of the revised guideline and, given the rumoured watering-down of the wording contained in the draft version (put out for comment in Nov 2020) we aren’t better off without the final version being published for the time being.
Let me explain why I think that.
Firstly, the 2007 incarnation of the guideline now has zero credibility and, given the state of the knowledge in this domain, patients now have strong grounds to resist GET being imposed upon them. Hence, I would contend that the November draft is actually the more helpful document for patients to discuss with their doctors, if they are willing to have the conversation. After all, those doctors who are likely to be unhelpful and intransigent are only going to continue in that vain if the rumoured wording in final version enables them to be so.
Furthermore, I sense that a breakthrough moment is not far away on the research front, so a watered-down guideline published now would be more of an obstacle to a further revision being undertaken relatively soon.
However, let’s not loose sight of the fact that immediate publication of the November draft (without alteration) would be the preferred outcome. I think that’s what most people want too.
I realise that I speak as someone who is relatively knowledgeable on these matters and one who is quite willing to argue my case with a difficult G.P (I recently got “delisted” for doing so), but the concern is for those who are newly diagnosed. But I guess that they can take some solace from the fact that a lot of the hard yards have already been done to eliminate the psychosomatic paradigm from the narrative of this illness and they haven’t therefore got to wait for another 20 years for change to come.
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I agree that but we would be better off without the final version being published – at all.
I notice that Valerie asserts (as not enough people do) that ME and CFS are two different things.
She always puts “ME/CFS” in ironic quotes to emphasise that it is a phony, cop-out name and not a valid medical term.
NICE’s refusal to address ME on its own – but always combined with CFS – is a sop to the psychiatrists who don’t accept that ME exists. As long as NICE’s guidance is for “ME/CFS” – and however long we wait – its final version will contain a form of words that allows CFS Clinics (as they are usually called) to continue using GET/CBT (without which, as they themselves admit, they would have nothing.)
If NICE was minded to give specific guidance on Myalgic Encephalomyelitis (M.E.) it could do so. But is isn’t, and never will be, while it feels obliged to accommodate the views of the psychiatric/CFS lobby who still can’t (or won’t) get their heads round that fact that M.E. exists.
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So frustrating when even the new guidelines are woeful. They are wordy but contain little to help. Yet, those that wrote the low quality research “supporting” GET/CBT have the power to stop even this tiny step forward. FFS stop pussy footing around and take legal action.
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