NICE – contemptuous and contemptible: the case for community publication of the “paused” guideline for “ME/CFS”

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.

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Background

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the English National Institute for Health and Care Excellence (NICE) began the process of updating the dangerously out-of-date guideline for “ME/CFS” (myalgic encephalomyelitis/chronic fatigue syndrome), originally published in 2007.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. 

The new draft guideline was published on 10 November 2020, followed by a 6-week stakeholder consultation period. Final publication of the new guideline was expected on 18 August 2021. The draft guideline removed/downgraded the most harmful treatments from its recommendations and, as such, was broadly welcomed by the patient community.

On 4 August 2021, as expected, the final version of the new guideline was circulated to stakeholders who had commented on the draft. By this stage, the guideline committee (now down to 18 members) had approved the final version (notwithstanding three resignations) and, according to the NICE manual, the NICE Guidance Executive would have signed it off. The fact that it was then circulated to stakeholders indicates that the process was now complete.

What happened then?

At just after 3pm on 17 August, less than 9 hours before the new guideline was due to go live, I, along with other stakeholders, received an email from NICE headed “MEDIA STATEMENT: NICE pauses publication of updated guideline on diagnosis and management of ME/CFS” (see end of this post for full statement).

The reasons NICE gives for this “pause” are unclear and not in accordance with “its usual rigorous methodology and process“, as proclaimed in the fourth paragraph of the statement. The inevitable inference from this lack of clarity is that someone, or some groups, raised objections at the eleventh hour and, completely at odds with its stated practice and procedure, NICE caved.

If this observation is correct then, at this point, NICE compromised its independence and credibility as an organisation. The inference of external meddling is boosted by media reports (eg. here [£] and here) indicating that, amongst others, the Royal College of Physicians and the Royal College of Paediatrics and Child Health did not accept the final version of the guideline.

Was this “pausing” of the guideline justifiable?

By this point, this action by NICE of “pausing” the publication should have been impossible. Such a step is not in accordance with its own manual which states quite clearly:

This step [releasing an advance copy to stakeholders] allows registered stakeholders to highlight to NICE any substantive errors, and to prepare for publication and implementation. It is not an opportunity to comment further on the guideline. [my emphasis]

Depending on what happens over the next few weeks, this action by NICE may require closer legal scrutiny.

The statement from NICE also contains the sentence: “Because of issues raised during the pre-publication period with the final guideline, we need to take time to consider next steps.” This is nonsensical. The guideline had already been published, albeit on a confidential basis, to a large number of people via the stakeholders who had commented on the draft. It had also been extensively leaked to the media (as would be expected by everyone, NICE included) in preparation for the anticipated public release on 18 August.

At this stage, the so-called “pre-publication period” and the opportunity to raise further issues had already passed. 

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Contemptuous and contemptible 

In pausing publication of the new guideline without proper explanation, NICE has demonstrated contempt for the “ME/CFS” patient community, a community described in its own draft guideline as one which may “have experienced prejudice and disbelief and feel stigmatised by people who do not understand their illness“.

Over the last few years, many severely ill patients have volunteered substantial amounts of time and exhausted their very limited resources in order to contribute to the guideline review process. This has come at massive cost to their own health and wellbeing.

In the absence of reasons and credible justification, NICE’s actions over the last few days can only be regarded as contemptible. 

Where are we now with the “paused” guideline?

NICE is an internationally respected organisation. Healthcare professionals and patients all over the world have a keen interest in both the guidance it produces and how it conducts itself. 

In the case of the “ME/CFS” guideline review process, something appears to have gone very wrong. There may be a valid reason for this misstep but the sketchy information provided so far is vague and lacking transparency. 

Earlier on in the review process, NICE sought evidence from patient groups concerning the harm which had been experienced as a result of treatments recommended in its 2007 guideline (Graded Exercise Therapy and Cognitive Behavioural Therapy). In April 2019, at very short notice, the requested survey was provided. Since that time, NICE has been on notice of the harms caused to many patients from its recommended treatments.

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THE CASE FOR PUBLISHING THE “PAUSED” GUIDELINE

From a legal point of view, there is limited precedent. However, two points should be considered:

• The new guideline has already been distributed to a very wide range of parties, both officially and unofficially. It is now most unlikely that the information contained within the guideline can still retain its quality of confidentiality.
• NICE began the process of updating the guideline in 2017. Initially, it was expected to take 2 years. It has been ongoing for nearly 4 years and now appears to have stalled indefinitely, with NICE having deviated from its own rule book without apparent justification. At this point, there is therefore a strong argument that the public interest in publishing the “paused” guideline is overwhelming. 

Once the final version of the guideline is made available to everyone with a legitimate interest in this process, it will then be possible for comparisons to be made between the “paused” version which was due on 18 August 2021 and any subsequent version which NICE may release. If there are unexpected substantial changes and/or modifications to the language, then that will be for NICE to justify in an appropriate forum in due course.

It is important to remember that, as things stand at the moment, the old guideline from 2007 which recommends harmful treatments for “ME/CFS” patients, remains the operative practical guidance for health and social care practitioners, the Department for Work and Pensions (DWP), local authority safeguarding teams and insurance companies. The “paused” guideline rejects such treatments but will not protect future patients until it officially replaces the old standard.

Nevertheless, publication of the “paused” version by members of the “ME/CFS” community en masse would provide a comparator to the 2007 version, one which had been signed off and therefore has a credibility well beyond the draft version (still currently available on the NICE website).

SUGGESTED OPTIONS FOR COMMUNITY PUBLICATION OUTSIDE NICE

I am a stakeholder in the NICE process but I did not comment on the draft so I do not have a copy of the “paused” guideline. Stakeholders who have received a copy of the guideline were required to sign a non-disclosure agreement (NDA). However, given NICE’s recent unprecedented action, the validity of those NDA’s must now be in doubt.

Options for community publication:

1. Anyone who has a copy of the “paused” guideline is welcome to contact me in absolute confidence. I could then, by agreement and format permitting, publish it on this blog, on behalf of the ME patient community. For details of how to get in touch see About.
2. The better option: if a critical number of organisations who are in possession of the “paused” guideline decide to publish contemporaneously, then mass publication would be achieved.

NICE would then need to consider whether there is (legalese alert) a proportionate response to community publication that does not interfere with the rights of individual members of the ME community in the UK under Articles 8 and 10 of the European Convention of Human Rights. 

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TEXT OF STATEMENT FROM NICE SENT BY EMAIL ON 17 AUGUST 2021

MEDIA STATEMENT

NICE pauses publication of updated guideline on diagnosis and management

of ME/CFS

NICE has today (17 August 2021) taken the decision to pause publication of its
updated guideline on the diagnosis and management of myalgic encephalomyelitis
(or encephalopathy)/chronic fatigue syndrome (ME/CFS).
The guideline recognises that ME/CFS is a complex, multi-system, chronic medical
condition where there is no ‘one size fits all’ approach to managing symptoms. The
causes of ME/CFS are still poorly understood and because of this there are strong
views around the management of this debilitating condition.
Because of issues raised during the pre-publication period with the final guideline,
we need to take time to consider next steps. We will hold conversations with
professional and patient stakeholder groups to do this. We need to do this so that the
guideline is supported.
NICE has used its usual rigorous methodology and process in developing this
guideline but despite the best efforts of the committee, that followed these to the
letter to bring together the available evidence and the real, lived experience and
testimony of people with ME/CFS, we have not been able to produce a guideline that
is supported by all.
We want to thank everyone who has contributed to this guideline and particularly the
committee and the patient groups who have worked so diligently. However, unless
the recommendations in the guideline are supported and implemented by
professionals and the NHS, people with ME/CFS may not get the care and help they
need.
In order to have the desired impact, the recommendations must be supported by
those who will implement them and NICE will now explore if this support can be
achieved.