NICE will now face court over the ME guidelines debacle

NICE logo - it has delayed the publication of ME/CFS guidance
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The National Institute for Health and Care Excellence (NICE) is going to be in court over its delay in publishing new guidelines for the treatment of myalgic encephalomyelitis (ME). One barrister told The Canary that NICE’s actions could leave its guidelines process “irretrievably flawed”.

The case is being brought by a child. They were previously harmed by treatment NICE had recommended. But the legal letters also expose that NICE, the guidelines process, and its overall role are looking utterly unfit for purpose. So, is it time for the government to step in?

NICE: the debacle continues

The Canary has been documenting the ongoing situation with NICE, ME (sometimes known as chronic fatigue syndrome (CFS)), and the community of people that’s built up around this debilitating neuroimmune disease. You can read our full analysis of the situation here and background to the story here. In short, NICE has been drawing up new ME treatment guidelines. These are the guidelines medical professionals are supposed to follow when treating someone with ME.

It was supposed to publish the final version on 18 August, but at the last minute it pulled them. This was due to organisations like Royal Colleges and NHS England not agreeing with the new guidelines. So, NICE is holding a round table event with stakeholders on 18 October to try and reach an agreement.

In the meantime, a legal case has been launched against NICE. The claimant is seeking a judicial review of its decision to not publish the guidelines. As The Canary previously reported, this is on the basis that NICE failed to follow its own procedures. Central to this story are treatments that many doctors and patients alike consider harmful. NICE’s old ME guidelines contained these treatments, but the update removed one and effectively downgraded the other. Some people feel that NICE delayed publication of the guidelines because of pressure from organisations that support the contentious and often harmful treatments it had removed or downgraded.

A fast-moving story

The lawyer representing the claimant, Peter Todd, has published the letter before claim – the first step in taking legal action – he sent to NICE. It outline’s the claimant’s case against the organisation. Todd initially gave NICE until 12pm on 6 October to respond to the claim.

NICE didn’t respond by the deadline. Todd said on Twitter that he would now be applying for legal aid. Then, on Thursday 7 October. Todd tweeted that NICE had responded at 5:31pm the previous day. He published its response. Finally, on Friday 8 October, Todd confirmed that the application for a judicial review was going ahead and that the claimant had got legal aid. Todd hopes to serve proceedings by Friday 15 October.

Read on...

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‘Process not science’

The Canary spoke with barrister and person living with ME Valerie Eliot Smith. She previously leaked NICE’s finalised guidelines. You can read The Canary‘s analysis of them here. Eliot Smith told us:

This challenge to NICE’s decision to pause publication of the new guideline for “ME/CFS” is most welcome. Todd… has set out a clear, robust case on behalf of the claimant…

The desired outcome of this claim is that NICE follows its own procedure by publishing the new guideline immediately, irrespective of the roundtable event on 18 October. It’s important to remember that this action is concerned with a judicial review of due process, not of the scientific evidence.

NICE has instructed DAC Beachcroft solicitors, the firm which represented the organisation in a judicial review of the 2007 guideline for “CFS/ME”.

So, what do the legal letters state? And more importantly, where do things now stand for people living with ME, their families, and their advocates?

The judicial review

The basis for the judicial review is, in short, that NICE failed to follow its own rules. The letter before claim outlines two areas where the claimant believes NICE has breached its legal obligations. In a section titled “Procedural impropriety”, it says that:

NICE has broken out of its prescribed procedures and now intends to repudiate its procedures and engage in politics. This is a fundamental betrayal of NICE’s constitutional role and prescribed methods. The Claimant intends to ask the court to intervene to prevent this unlawful use of NICE’s powers.

In a section titled “Irrationality”, it continues:

public bodies such as NICE must use their legal powers rationally. …

NICE have acted irrationally in that they have ceased to have regard to scientific evidence, but instead are being materially influenced by irrelevant factors such as whether those who may have commercial interests need to be persuaded to support a change which will adversely affect those interests.

As Eliot Smith told The Canary:

The crux of this case is that NICE has strayed so far outside its own prescribed procedures that it has exceeded its powers, thereby acting unlawfully and/or irrationally.

Meanwhile, the response that NICE’s solicitor sent to Todd, which he subsequently published, has sparked anger.


The response outlines why NICE’s lawyers believe there’s no case to answer. On procedural impropriety, it states that:

NICE does not intend to “engage in politics” or “engage in any fundamental betrayal of its constitutional role and prescribed methods.” The Manual does not expressly provide circumstances justifying a pause in publication of guidelines, but nor does it expressly exclude this possibility

On the issue of irrationality, the letter states that NICE delayed publication to “ensure the effectiveness” of the new guidelines. It noted how the legal claim was based on a “misconception” of this. The letter questions the claimant’s assertion that NICE was effectively kowtowed by “commercial interests”. It also denies that NICE’s decision to pause publication was influenced by “individual stakeholders”.

One interesting point that NICE’s lawyer’s letter threw up was over the real-world impact of the guidelines. It states that:

NICE guidelines are not binding. They inform the judgement of bodies providing NHS services and their clinicians, nothing more.

In other words, the NHS and doctors don’t have to adhere to what NICE says in its guidelines. This shows a major discrepancy in NICE’s actions and casts doubt on its claims about wanting medical professionals to support the new guidelines – when it’s legally not necessary for them to do so, anyway.

‘Making up the rules’

Eliot Smith told The Canary:

The response to this current claim is predictably disingenuous. It is reduced to picking away at individual points in the hope of obscuring the significance of the new guideline which represents a radical shift away from harmful treatment recommendations.

NICE’s main defence is that it has a wide discretion. This is quite true. Nevertheless, the sentence “[t]he Manual does not expressly provide circumstances justifying a pause in publication of guidelines, but nor does it expressly exclude this possibility” demonstrates a degree of desperation which would be comical if it were not so serious.

Moreover, NICE is created and governed by statute. It has no power to make up the rules as it goes along.

“Influenced by external interference”

Eliot Smith explained further why NICE appears to be at fault:

In Paragraph 14 of the response, NICE concedes three important points:

  • Because of the large number of comments on the draft guideline (issued in November 2020) NICE postponed its final publication date to 18 August 2021 in order to respond fully and complete all of the pre-publication processes.
  • Having done that, NICE then released a confidential advance copy to all stakeholders who had commented on the draft.
  • “Following that confidential release, NICE received a number of communications raising issues with the guideline from representatives of Royal Colleges and NHS England”.

Point three is a clear admission that, at this stage, NICE allowed itself to be influenced by external interference. NICE is supposedly an independent body. By this stage, such interventions should simply not have been possible.

So, it seems it is now up to a court to decide if there is a case for a judicial review. Meanwhile, at the centre of this story are people living with a life-changing disease that’s often severe and chronic.

NICE: subjecting patients to further harm?

The letter before claim outlines the situation for the claimant. It stated:

The Claimant was well, until, in August 2012, he suffered a bout of sickness and diarrhoea which lasted about 2 months. His sister suffered the same illness at the same time and whereas she recovered, [he] remained unwell. In December 2013 he was admitted into hospital due to severe headaches and when discharged he was diagnosed with post-viral CFS/ME.

He was given treatments according to the current NICE guidelines: CBT where he was instructed not to talk about his symptoms but just push through them and Graded Exercise Therapy [GET] which was a continual gradual increase in activity, regardless of the state he was in. This treatment caused him significant harm. By 5th March 2014 his Mum noted:

“[he] is in a dreadful state now. Constant pain, visual problems, still at school and finding it hard to concentrate. They failed to record tiredness/exhaustion. He’s in constant pain, shaking in his sleep, mumbling, cold legs from knee to ankle, asking if he is going to die”.

Encouraged by the guidelines, [his] post-exertional malaise [PEM] was ignored. Since that time he has been often bed-bound. He has come to understand the harm that the NICE recommended therapies caused to him. [He] is worried that if he seeks treatment from the NHS he will be further subject to the harmful regimen specified in the NHS by the current NICE guidance.

His circumstance will ring true to many people living with ME.

But there’s another factor in this story that has not yet been fully explored. And it’s that NICE is directly answerable to the government.

Should the government intervene?

NICE was established in its current form under the Health and Social Care Act 2012. Its framework agreement with the Department of Health and Social Care (DHSC) laid out how it would work with other bodies. Specifically, the agreement states firstly that:

NICE’s legislative framework describes its general functions and provides that its work is commissioned by ministers or by NHS England. NICE’s work programmes are normally set by ministers and NHS England several years in advance and the development of individual pieces of guidance can take between 6 months to 2 years.

It also states that the DHSC secretary of state (currently Sajid Javid) is “accountable to parliament” for NICE and its “performance”. And moreover, the agreement goes on to say that the DHSC permanent secretary (currently Chris Wormald) is responsible for making sure “arrangements are in place” to do the following:

  • address significant problems in NICE, making such interventions as are judged necessary. …
  • bring concerns about the activities of NICE which require explanations to the DHSC board and give assurances that appropriate action has been taken.

In other words, the government could intervene over NICE’s actions in relation to the ME guidelines. It may require an MP to raise the issue formally via an “urgent question” in parliament first.

ME guidelines process: “irretrievably flawed”?

Eliot Smith summed up the situation to The Canary:

NICE’s response completely fails to address the central issue raised by the claim. If it intends to publish the new guideline regardless of the outcome of the roundtable, then there is no justifiable reason why full publication has not already taken place.

However, if NICE has not yet published the guideline on the basis that there might be some changes or tweaks as a result of the roundtable event, then this either reopens a process which has already been completed or it begins a whole new consultation and evidence review.

There is no credible justification for those options. If either was to happen, it would confirm that this process is fundamentally and irretrievably flawed.

Moreover, the legal wrangling has exposed NICE as seemingly less and less fit for purpose. Its own admission that doctors are under no obligation to follow its guidelines makes a mockery of not only this whole situation but also of NICE’s role in deciding clinical practice in England.

Meanwhile, the waiting game for people living with ME, their families, and advocates continues. As The Canary previously stated, there is no guarantee the court will accept the grounds for a judicial review. But with each development of this story, more pressure is placed on NICE to take a long, hard look at its actions and the effect they have on chronically ill people.

Featured image via NICE – YouTube 

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