🌍 Much ado about a lot

One of the most remarkable ME-vents of this year was the publication of the renewed Guideline of NICE and its postponement on August 17.  About that last aspect Dom Salisbury blogged in What Took Place Behind the Scenes.

Patient, patient advocate and barrister Valerie Eliot Smith followed the entire publication process closely and wrote a number of blogs about it. With her permission, we compiled this article using parts of them.

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the English National Institute for Health and Care Excellence (NICE) began the process of updating the dangerously out-of-date 2007 guideline for “ME/CFS”.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.

Shortly afterwards, it transpired that this pause was the result of external interference from a lobby group of representatives from some of the Royal Colleges and NHS England.

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. 

On 18 October the roundtable took place, [firstly with seemingly positive reports of broad agreement but then with what has transpired to be a deceptively positive outcome].

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”. 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. 

On 13 October, NICE followed this up with two more documents under a new heading of “Stakeholder Workshop”. The first document set out the discussion points for the meeting, being the proposed diagnostic criteria, ME in children and young people, GET, CBT and the Methodological approach: questions about the approach taken to the evidence, with suggestions that studies have been inappropriately excluded or downgraded.

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

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. 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.

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. 

Cracks in the Table

An amended version of the new guideline was published on 29 October 2021.

The roundtable event on 18 October (minutes here) purported to address concerns over implementation of the new guideline. This meeting appeared to secure general consensus on the new document. However, subsequent developments indicate that this may not have been as successful as was first thought:

STATEMENT ON THE UPDATED NICE GUIDELINE

~ 29 October 2021

“The new NICE guideline for the illness termed “myalgic encephalomyelitis/chronic fatigue syndrome” or “ME/CFS” is a small but welcome step in the right direction.

While there is still a long way to go, and the new guideline is very far from ideal, the [attempt at] removal of the most harmful treatment recommendations is a significant milestone on the road to proper recognition and treatment for this extremely disabling, occasionally fatal, illness.

[However, it remains to be seen how implementation of the new guideline will work. Even before the release of the new version, evidence emerged about how GET will be repurposed in treating patients at a “chronic fatigue” clinic. The new phrase appears to be “graded activity management/GAM”.

Even more worrying (though not entirely unexpected) is the response by the Royal Colleges issued later on 29 October, which indicated that they do not agree with the new guideline and will continue to promote their own brand of exercise and CBT treatments.

It seems that there were some cracks in NICE’s round table which are now becoming apparent. The optimism expressed in NICE’s news release may have been premature.]

 [In any event,] the current situation for “ME/CFS” patients is still dire.

  • The new guideline acknowledges that there is currently no diagnostic test and no cure for “ME/CFS”. There is no recommended treatment, only management of energy and symptoms.
  • The guideline recognises: “that people with ME/CFS may have experienced prejudice and disbelief and could feel stigmatised by people (including family, friends, health and social care professionals, and teachers) who do not understand their illness.” (para 1.1.2)

These are shocking admissions to be making about a devastating illness which was first documented nearly a hundred years ago.

[However,] it is to be hoped that this updated guideline will usher in a new phase in the history of this illness, thereby generating a refreshed political will and ultimately triggering a cancer-style “moonshot” initiative. This would be a vital step in the process of beginning to address the neglect, stigma and harms experienced by patients over many decades.

Whatever happens now, it is too late for the millions of patients worldwide who have already died during the last century of “ME/CFS” disbelief. Many patients never had their illness validated nor were they treated with respect and compassion in their lifetimes.

The time has come to call for an independent public inquiry into the history of the treatment of “ME/CFS” patients. Without such an inquiry, the systemic injustice and abuse experienced by patients cannot begin to be addressed.

This guideline [has the potential to] open up a new chapter in the shameful history of this maligned illness. The opportunity to redress the wrongs of the past and create a better future must be seized with urgency and enthusiasm.”

Thanks to Valerie Eliot Smith for the permission to compose large parts of her precious blogs on this subject

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