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 the full background to this post see previous post here. 

NB. 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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The story so far

In 2017, the English National Institute for Health and Care Excellence (NICE) began the process of updating the dangerously out-of-date 2007 guideline for “ME/CFS”. After several delays, the new guideline was completed and signed off by NICE’s guidance executive. On 4 August 2021, it was distributed to NICE representatives and qualifying stakeholders. The document was to remain confidential until 12.01am on 18 August 2021.

According to NICE’s own manual, when publication took place on 4 August, the process had been completed. No further changes could be made from this point onwards, save for minor corrections.

On 17 August 2021, nine hours before general release of the new guideline, NICE “paused” publication of the document but gave no credible explanation or detail of any exceptional circumstances justifying its extraordinary action. In addition, the “pause” in publication meant that NICE could claim that this final version of the guideline, already distributed to numerous parties, remained confidential. However, I have disputed the validity of this claim of confidentiality in an earlier post.

Contemporaneous media reports suggested that this eleventh-hour development was the result of external interference by disgruntled parties who were opposed to the new guideline. This is in direct contravention to NICE’s own prescribed procedure and such an action at this late stage should have been impossible.

NICE now appears to have sacrificed its independence as an executive non-departmental public body of the Department of Health, and casually derailed its own process.

Since then…..

NICE has issued two statements which are startling both in their opacity and their breathtaking disregard for the international ME patient community which has now been kicked into a long-term, traumatising state of limbo. This is causing extreme distress to thousands of patients worldwide, with no apparent end in sight.

After the initial shock of the “pause” in publication, patients were then kept waiting until 27 August for the next statement. This gave details of a roundtable event, to be held (optimistically) in September. Unsurprisingly, on 10 September, this was updated to sometime in October [date: secret]. This meeting was to be chaired by an independent person [identity: secret], with selected representatives from the ME community and other parties [identities: secret]. The selected, secret invitees were required to sign non-disclosure agreements (NDA’s).

This series of actions by NICE ending in a draconian information blackout on what is supposed to be a transparent process means that this fiasco is now fatally-flawed. 

The second statement was issued on 21 September 2021. Let’s take a look:

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NICE’s STATEMENT OF 21 SEPTEMBER:

Paragraph 1

The roundtable meeting to discuss the updated guideline on the diagnosis and management of ME/CFS [sic] will be held on October 18th in London. It is being convened after publication of the guideline was paused when issues were raised by some professional groups during the pre-publication period. 

This sounds remarkably like a covert attempt to re-open the consultation process but including selected groups only. My response to this comes straight out of my earlier post of 25 August:

“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 [to open/re-open the consultation process], then NICE should publish the new guideline of its own volition without further delay.” 

Paragraph 2

“The roundtable will be an opportunity for all parties to discuss key issues raised prior to publication. The decision on next steps will be made by NICE, taking into account comments made at the roundtable. NICE will release the agenda ahead of the meeting and minutes will be published afterwards.”

“The roundtable will be an opportunity for all parties to discuss key issues raised prior to publication.” According to NICE’s manual, issues raised “prior to publication” can no longer be discussed or changed. That ship sailed on 4 August.

“The decision on next steps will be made by NICE, taking into account comments made at the roundtable”. This suggests that changes could be made to what was supposed to be the final version of the new guideline. Again, completely contradicting NICE’s own manual.

“NICE will release the agenda ahead of the meeting and minutes will be published afterwards.” Who is setting the agenda? What criteria are being used? The agenda will direct the purpose and outcome of the meeting. Why the need for NDA’s? Again – transparency?

Paragraph 3

“NICE has invited relevant professional organisations to attend the meeting, plus representatives from interested patient groups.  Unfortunately there are too many patient groups to invite everyone, but we have aimed to ensure a full range of perspectives.”

“NICE has invited relevant professional organisations to attend the meeting, plus representatives from interested patient groups.” Who is invited and who decided which organisations were “relevant“? How were any of them selected? Who is excluded and why? What about all the other non-invited stakeholders who also contributed to the final version of the guideline?

Paragraph 4

“Professor Dame Carol Black has kindly agreed to act as an independent chair of the roundtable discussion.  Dame Carol is an experienced chair who is independent of NICE and of the development of the ME/CFS guideline. She will facilitate the discussion and will not take part in NICE decisions.” 

This one is quite straightforward. Dame Carol Black cannot be an independent chair in this process for three reasons.

1. She has long associations with the Royal Colleges which have clearly been instrumental in the external interference which has created this bizarre set of events.
2. She has been an adviser to the government on various occasions. According to Wikipedia: “In 2006, the government led by Tony Blair made Black its national director for health and work and asked her to promote its policies across Whitehall, especially within the Department of Health and the Department for Work and Pensions. She described her role as being to try to keep people “healthy, well, resilient and in work.” 
   Her agenda has been to get people back to work with a focus on behavioural and psychological interventions on the basis that sick people remain long-term sick only because they think they are sick, not because they actually are sick. This dangerous fallacy lies at the very heart of the long standing dispute about the treatment of ME patients and has contributed to the neglect and abuse experienced by many in the international patient community.
3. She has shared platforms with various members of the psychiatric lobby who have themselves cultivated and prolonged the traumatic experiences of many in the ME patient community.

Dame Carol is completely unacceptable as an “independent chair” for this roundtable event. Anyone suggesting that a chair is purely a neutral party who has no bearing on the outcome of a meeting is either inexperienced in the conduct of meetings or simply deluding themselves.

For these reasons, representatives of the ME patient community who are planning to attend this meeting should collectively refuse to accept Dame Carol as an “independent chair”.

Paragraph 5

Dr Paul Chrisp, director of the Centre for Guidelines at NICE, said: “We acknowledge that patients will be concerned about these further developments in what has been a long and difficult guideline process. We hope that by holding a roundtable discussion we can understand the issues raised by the professional bodies to inform NICE’s thinking on the next steps for publication of the guideline.”

This patronising sop to the ME patient community is beneath contempt and not worthy of further comment.

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What can be done now?

In terms of the roundtable meeting, only the selected few who are involved or invited can exert any influence over what happens there. Most members of the ME community who will be directly affected by the outcome of this meeting have been left stranded on the outside of this exclusive tent, unable to see in and observe events which may shape the rest of their lives and the lives of many others yet to be diagnosed.

There are calls for livestreaming and full disclosure of all documentation relating to this meeting. I suspect they will not be successful. The fact that attendees had to sign NDA’s doesn’t inspire confidence in the transparency of the process.

The litigation options

I have written previously about ME-related litigation and I understand that some groups within the UK’s ME patient community are currently considering their options. Whilst this is to be welcomed, nevertheless it is still inexplicable that none of the established ME charities have explored the possibility of legal action in the past (or if they have, they’ve been keeping very quiet about it).

Whilst patient groups could achieve a significant amount, action taken by recognised charities would have more impact and legitimacy than informal, uncoordinated groups. Action taken by charities would also have a better chance at pooling resources and depersonalising what is always a challenging process. The absence of such action by the charities remains a mystery.

• Personal injury litigation by a patient/patients who have suffered harm as a result of a NICE-recommended treatment such as Graded Exercise Therapy/GET

I have already written about this in a post from last year (in the second half of the post) COVID-19, NICE and ME: towards litigation? With the NICE process on indefinite hold and no certainty around what the new guideline will contain, the case for litigation has only become stronger for anyone with sufficient resilience and resources to pursue it.

NB: such an action will require hard evidence from an identifiable claimant who is willing and able to give evidence to a court. Anonymised case histories alone will not provide sufficient evidence with which to commence legal proceedings although they may be useful for other purposes.

• Judicial review/JR

Again, I have already written about the possibility of judicially reviewing NICE’s decisions in this process in a post from June this year Possible responses to the new NICE guideline for “ME/CFS” (again, second half of post). The rationale for considering this avenue has also been strengthened by recent events.

Time limits are of concern as any application to launch JR proceedings should take place within three months from the date of decision on which review is sought. Given the incomprehensible and unpredictable nature of NICE’s actions, the time limit may not be as rigid as first appeared (ie. three months on from the decision to “pause” publication on 17 August 2021). As I said on Twitter recently:

With the uncertainty re the outcome of the @NICEComms process (or lack of it) there may be some flexibility on time limits. Would depend on final outcome. An application to the High Court to commence proceedings out of time might succeed, in theory. But NOT a desirable situation.

Above all else, the most important part of exploring litigation is to get professional advice from an expert legal team. These are highly complex areas of law with a very wide range of issues to be considered. Don’t expect pro bono representation – it’s unlikely you’ll get it. An initial opinion, just on the merits of bringing a case, may cost upwards of £5000. Anything less will probably not be worth having. 

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FINALLY – that “final” version of the “ME/CFS” guideline…..

For anyone who hasn’t already seen it: my previous post Abuse of process & abuse of power: a NICE publication (with file download) contains a link towards the end of the post from which the final version of the guideline can be downloaded (ie. the one which was distributed on 4 August 2021 but “paused” on 17 August).

NOTE that this version, although it is marked “FINAL”, is not operative unless and until it is published by NICE itself. 

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Photo credit: “Amsterdam 2011” – Valerie Eliot Smith