Abuse of process & abuse of power: a NICE publication (with file download)

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 am a barrister.

For the full background to this post see previous post here. Alternatively, there is also a summary for new readers at the end of this post. Please scroll down to access it.

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 current situation with the “paused” publication of the new NICE guideline for “ME/CFS”

On 17 August 2021, the National Institute for Health and Care Excellence (NICE) “paused” the publication of the new guideline for “ME/CFS”, 9 hours before it was due to be released. Many stakeholder groups and other parties had been given access to the guideline 13 days earlier, on 4 August. The document was to remain confidential until general release on 18 August.

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

The statement which NICE then issued by way of explanation did not volunteer any information about the exceptional circumstances which might have clarified or justified this extraordinary deviation from its own prescribed procedure. 

At this point, the process of updating the guideline became flawed. 

The next development

On 27 August, NICE issued a further statement regarding a “roundtable event”. It stated:

The [roundtable] meeting, which will be held in September 2021*, will have an independent chair and will include representatives from patient organisations and charities, relevant professional societies and from NHS England and NHS Improvement, NICE and the guideline committee. 

*Latest update on 10 September (blink and you’ll miss it): apparently the roundtable will now be held in October 2021.

The flabby wording of NICE’s statement has completely failed to clarify publicly any of the vital issues:

• The purpose of this event (NICE has previously used a roundtable to discuss implementation of a guideline but this was after final publication, not before)
• How invitees have been selected [ETA: and who they are (it’s a secret)]
• Why there is a requirement for invitees to sign confidentiality agreements
• The process of the appointment of an “independent” chair

At this point, we are four weeks on from NICE “pausing” publication of the guideline. The international ME community has been pushed from what initially appeared to be a temporary hiatus into a long-term, traumatising limbo. This is now continuing to cause extreme distress to many in the worldwide community, with no end in sight.

Obfuscation as denial of fairness and justice

Rumours and purported “leaks” have been spreading far and wide. These are dangerous and unsettling. The entire process has become shrouded in secrecy and speculation.

NICE has allowed external interference to derail its procedures, in direct contravention of its own manual and against all fundamental principles of fairness and natural justice.

There is a strong argument that this process is now not just “flawed” but has become “fatally flawed” ie. irretrievable. This has been brought about as a direct result of NICE’s extraordinary actions and its failure to provide adequate justification, explanation or information regarding its next steps.

It cannot now be argued that NICE is acting in good faith or with any degree of independence.

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AS I’VE SAID BEFORE ON THIS BLOG: LIKE ALL PUBLIC BODIES, NICE HAS A WIDE DISCRETION IN HOW IT EXERCISES ITS STATUTORY FUNCTIONS. HOWEVER, RECENT EVENTS SHOW THAT IT HAS NOW GONE BEYOND WHAT IS REASONABLE OR JUSTIFIABLE.

NICE’S ACTIONS SINCE 27 AUGUST AMOUNT TO AN ATTEMPT TO STIFLE LEGITIMATE DEBATE BOTH INSIDE AND OUTSIDE THE INTERNATIONAL ME COMMUNITY.

KNOWLEDGE IS POWER; NICE’S ACTIONS IN WITHHOLDING INFORMATION NOW AMOUNT TO AN ABUSE OF PROCESS AND AN ABUSE OF ITS POWER. 

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The case for community publication 

The new guideline does not become operative until it is published by NICE.

We have no idea when that is going to take place. I have argued before that community publication could and should take place – see previous post here. However, it seems that this is not an option at this stage. 

As I said in that previous post, the purpose of community publication would be:

“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.” 

We have reached a point where the public interest in making the “paused” guideline available is overwhelming. In the absence of further explanation from NICE, ME patients worldwide now have an absolute right to see what that guideline looks like. Whilst NICE guidance is a British publication, it provides templates which are widely followed in many other countries. 

Harms caused?

In the intervening period between when publication was “paused” and any future publication date:

• How many ME patients will have started a programme of treatment, as recommended by the “current” (ie. 2007) NICE guideline for “CFS/ME”?
• How many of these patients will go on to experience severe harm and setback as a result of undertaking such treatment?
• How will NICE compensate those patients for the harm caused by the delay in publication? 

The case for individual publication

I first flagged up the fact that I was prepared to make the new guideline available here on 20 August 2021. I have mentioned @NICEComms on Twitter on numerous occasions so NICE has been on notice of my intention since then.

If NICE wished to prevent me from publishing the document, it has had ample opportunity to do so.

As I indicated earlier, I am not affiliated to any organisation or group in the ME community. For that reason, and the reasons given above, I am making a link available (below) from which the 17 August 2021 “final” version of the guideline can be downloaded.

Before deciding whether or not to download the document, please read the short statement below which I had prepared for when the guideline was to be released on 18 August 2021. I had not seen the final version at that stage but I had been given a helpful steer in advance by someone who had. 

Like the document, my statement is pending indefinitely but it may be useful to read it first.

Again: the decision to make this information available is mine and mine alone. 

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MY STATEMENT ON THE UPDATED NICE GUIDELINE [still pending]

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 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. 

The NICE guideline committee responsible for this process is to be commended for maintaining an independent stance and for its adherence to the evidence which it reviewed. [???]

The current situation for “ME/CFS” patients is still dire. The new guideline acknowledges that there is currently no diagnostic test, no treatment and no cure for “ME/CFS”, and that many patients have experienced “prejudice and disbelief”. These are shocking admissions to be making about a devastating illness which was first documented nearly a hundred years ago.

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 opens 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.

[18 August 2021]

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DOWNLOAD THE DOCUMENT 

For anyone who chooses to download this document, please note that you will be downloading it directly from this blog where it is being stored in the Cloud.

83 pages (image file): click on this link MECFS NICE Guidelines (unpublished final)

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Summary of the background 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 “roundtable event” proposal

After ten days of consternation and confusion in the ME patient community, NICE issued a statement which included the following paragraph: 

The [roundtable] meeting, which will be held in September 2021, will have an independent chair and will include representatives from patient organisations and charities, relevant professional societies and from NHS England and NHS Improvement, NICE and the guideline committee. 

Given that the process of updating the guideline had already been completed, it’s somewhat puzzling to see what purpose this event could possibly fulfil.

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