NICE publishes new guideline for “ME/CFS”: cracks in the table emerge [updated]

THIS POST WAS UPDATED ON 1 NOVEMBER 2021 TO REFLECT DEVELOPMENTS SINCE 29 0CTOBER. EDITS ARE SHOWN IN SQUARE BRACKETS [like this].

Disclosure: I have lived with the discrete illness myalgic encephalomyelitis (ME) 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.

Note: there is a summary of the background to this story at the end of this post. Please scroll down to access it.

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The English National Institute for Health and Care Excellence (NICE) has today, 29 October 2021, published the new guideline for diagnosis and management of the illness which it terms “myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome” or “ME/CFS”. This replaces the dangerously flawed “CFS/ME” guideline from 2007.

The publication of the new guideline follows an abject failure of due process by NICE. The new document was due for final publication on 18 August 2021 but this was “paused” at the last minute as a direct result of external interference by representatives of the Royal Colleges and NHS England.

This unprecedented “pause” in publication has caused completely unwarranted distress to millions of members of the international ME community* as the newly published document is broadly similar to the previous unpublished version (available to download from this blog in an earlier post here).

[A 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 (see statement below).

The results of NICE’s capitulation to a flawed process are beginning to show. Inevitably, this gives rise to cause for concern regarding its long term outcomes and potential for detrimental effects on the international ME community.]

There was extensive media coverage of the new publication, for example, by the BBC and The Guardian. Both highlighted the [apparent] rejection of harmful and long disputed Graded Exercise Therapy (GET) as a treatment for “ME/CFS”.

* NICE guidance generally is used as a template by many other countries

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My response to the new guideline is as follows:

STATEMENT ON THE UPDATED NICE GUIDELINE

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.]

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[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.

~ 29 October 2021

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SUMMARY OF PREVIOUS EVENTS 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 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.

On 17 August 2021, 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 claimed that this final version of the guideline, already distributed to numerous parties, remained confidential. (I have disputed the validity of this claim of confidentiality in an earlier post.) According to NICE’s own manual, the distribution and publication on 4 August completed the process. No further changes could be made from this point onwards, save for minor corrections.

It became clear that this eleventh-hour development was the result of external interference by representatives of the Royal Colleges and NHS England 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.

Since then, NICE has issued two statements. The first, on 27 August gave details of a roundtable event, to be held in September chaired by an “independent” party. This was then updated to 18 October. Selected representatives from the ME community and other parties would be invited to attend subject to signing new non-disclosure agreements (NDA’s).

The purpose of this event was to “gain support for the guideline to ensure effective implementation”, despite the process having been completed, signed off and the document already distributed to an extensive number of people.

A second statement was issued on 21 September 2021 further attempting to justify this bizarre series of events. The statement also announced Professor Dame Carol Black as the “independent” chair, someone whose history has made her completely unacceptable to many in the ME patient community.

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].

The new guideline was then published on 29 October 2021.

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