A barrister has leaked controversial guidelines from a government body. The National Institute for Health and Care Excellence (NICE) has been at the centre of a growing storm. This is because it delayed the publication of guidelines for a debilitating illness known as ME, at the last minute.
NICE’s delay in publication was seemingly due to pressure from people with contentious vested interests; ones which are at odds with the professional opinions of many others. And now, with the full guidelines in the public domain – it’s clear why those with certain agendas lobbied NICE to get the guidelines stopped. But this continuation of what many people consider the abuse of people living with ME has caused widespread distress in the community.
These guidelines have been riddled with controversy for chronic illness communities. People living with ME have long campaigned against the distress and abuse they suffer from ME treatment options which were based on discredited research. The leak of these guidelines brings forward a whole host of issues:
- NICE appear to have delayed the publication due to the influence of proponents of certain discredited treatments.
- It has now referenced data-led research – potentially another reason why proponents of these treatments may have kicked off.
- NICE appears to have bowed-down somewhat over another one of these treatments.
- There could now be questions over potential legal action.
- NICE’s own credibility hangs in the balance.
NICE and ME: a history of controversy
As The Canary has been reporting, NICE has sparked anger among the chronic illness community. This is because it delayed publication of new guidelines into the treatment of myalgic encephalomyelitis (ME). The neuro-immune disease is sometimes called chronic fatigue syndrome (CFS).
NICE updating its ME treatment guidelines has proven controversial. This is because its previous guidelines recommended two treatments based on flawed research. These were graded exercise therapy (GET) and cognitive behavioural therapy (CBT). You can read The Canary‘s full analysis of the NICE guideline update here.
As we previously wrote:
GET has been marred by controversy. It was based on the PACE trial. This was a clinical study into ME that the Lancet published in 2011. Its findings into GET and (CBT) as treatment for ME have been widely disputed. One prominent ME doctor called it “scientific and financial fraud”. An MP said it was potentially one of the “biggest medical scandals of the 21st century”. Some of the trial’s authors had conflicts of interest with private insurance companies. The UK social security body the Department for Work and Pensions (DWP) part-funded the trial. This led the MP to say:
‘One wonders why the DWP would fund such a trial, unless of course it was seen as a way of removing people on long-term benefits and reducing the welfare bill’.
Its original authors disagree with the criticisms. But along with the scientific evidence, many patients say that GET and CBT did not help them. Some say it made them worse. In 2017, the US Center for Disease Control (CDC) removed CBT and GET as recommended treatments.
Leaked: the finalised guidance
In November 2020, NICE published the draft of its new guidance. It had removed GET and downgraded CBT from a treatment to a supportive therapy to help patients deal with living with a chronic illness and its symptoms. On 18 August, it was due to publish the final version that medical professionals would have to adhere to. But media reports said that some professional medical bodies like the Royal College of Physicians had refused to endorse NICE’s new guidance. NICE itself said that its final guidelines were not “supported by all”. So, it pulled the plug on publishing them.
NICE later announced it would hold a roundtable meeting with stakeholders in September. This was to discuss how best to move forward. It’s since pushed this back until October. On social media, there have been reports of who will be attending the event. Some people have alleged that certain reported members of the roundtable event, including its chair, have conflicts of interest over the PACE trail, GET, and CBT; that is, they are proponents or supporters of them. So far, NICE has not confirmed who will be at the meeting.
Now, a former barrister who is also visiting scholar and person with ME, Valerie Eliot Smith, has published the NICE finalised guidelines. You can read her blog here, and the guidelines here. She does not say who gave them to her, but she wrote that she warned NICE she would be publishing them. The guidelines appear genuine. And while some parts haven’t changed from the draft, one major area has.
The Canary has analysed both the draft and finalised versions. On a first reading, it appears that NICE’s approach and treatment recommendations for ME have broadly stayed the same; albeit for some changes of phrasing and wording. For example, NICE has expanded the section on pain slightly in the final guidance compared to the draft. The draft section on nausea has been removed completely from the final version.
But something big has changed between the draft and finalised guidelines – namely NICE’s own reasoning for removing GET and downgrading CBT. At the end of each copy it laid out how it came to its recommendations. And these revisions are perhaps some of the most telling aspects of this story. Because in short, in the final version NICE has been more critical of GET. But it has also watered-down its comments on CBT.
For example, the draft guidelines consisted of three paragraphs of NICE’s reasons for its decision to remove GET as a treatment. In the final document, this had increased to six paragraphs. But the stand out difference was in NICE’s view of GET. The draft guidelines stated that:
the committee considered the benefits and harms associated with graded exercise therapy that had been identified in the qualitative evidence and their own experiences of these types of interventions. They recommended not to offer any programme based on fixed incremental physical activity or exercise, for example graded exercise therapy or structured activity or exercise programmes that are based on deconditioning as the cause of ME/CFS.
But the final version went much further. For example, it stated that NICE had drawn on both “quantitative” (measurable, data-led) and “qualitative” (patient self-reported) evidence when looking at the “benefits and harms” of GET. The draft guidelines only stated qualitative.
This is a big change. It could indicate NICE believed come the final version that the data-led, research-based evidence was strong enough to ban GET. Previously, it was relying on patient-led information. NICE also added treatments that are based on “exercise intolerance theories” as being banned, as well as those based on “deconditioning” theories; in the draft it was just the latter.
But NICE has done the opposite with its reasoning for downgrading CBT.
The draft contained five paragraphs of NICE’s reasoning for its changing of guidance on CBT. But the finalised version was reduced to four with some changes. Interestingly, the final guidance included an extra rationale for NICE recommending CBT as a supportive therapy. It stated that it should be used to:
reduce the distress associated with having a chronic illness
Also, crucially, the main section on CBT where NICE detailed how it should be delivered has also been watered-down. The final version removed a section where NICE had said in the draft that medical professionals must explain to people with ME that CBT:
does not assume people have ‘abnormal’ illness beliefs and behaviours as an underlying cause of their ME/CFS, but recognises that thoughts, feelings, behaviours and physiology interact with each other
takes a non-judgemental, supportive approach to the person’s experience of their symptoms and the challenges these present.
So, why did NICE increase their criticism of GET? And why did it reduce its criticism of CBT?
Opening the legal floodgates?
One possible explanation could be that NICE believed its draft reasoning wasn’t robust enough around GET. The anecdotal harm this therapy has caused patients is well-known (qualitative). There are also the re-evaluations of the PACE trail (some from nearly five years ago) which found GET not to work (quantitative). So, maybe NICE thought it needed to be seen to be giving stronger clarity on why it’s banning GET; possibly to protect itself.
This would then also explain why certain medical professionals kicked-back against the final guidelines. NICE admitting that there’s quantitative (and historical) evidence that GET is harmful could potentially open up the floodgates for compensation claims against medical professionals. The research on harm is not new. As Lib Dem leader Ed Davey said in 2019:
Shouldn’t graded exercise therapy be removed as a treatment option even before the NICE guidelines are reviewed? Given the evidence that people are being harmed, isn’t it a possibility that a future court could compensate ME sufferers if they continue to be prescribed GET given we know that evidence, the minister knows that evidence, and medical professionals know that evidence? The idea that the current NICE guidelines are in practice till October 2020, I find quite scary
He said at the time that the government and its chief medical officer should intervene in NICE. Davey continued:
There will be a case, in future if [GET] continues… [for] people who are harmed to go to court and to seek compensation.
CBT: the easy option
The opposite could be true of CBT. Given it’s a talking therapy where the emphasis is placed on the patient to ‘become their own therapist’, then the likelihood of any successful legal claims could be lower. In the context of ME and GET, CBT has been wrongly (and often harmfully) used to try and cure a non-existent fear of exercise in patients. But CBT as a supportive intervention in ME is not always a bad thing. Prominent ME and CFS practitioner Dr Sarah Myhill noted she has seen patients made worse by CBT, but:
There is a place for CBT, but only when the underlying physical issues have been identified and only when these physical issues have been, for the most part, resolved. Some patients won’t ever ‘need’ CBT and will happily progress to good fitness levels without this intervention.
But still, NICE made clear that CBT is not a cure or treatment for the disease. This, combined with its comments on GET and the overall thrust of the finalised guidelines, may show the other reason why some medical professionals kicked-back against it.
Blowing the ‘all in your head’ argument open
With its finalised guidelines, NICE essentially said that telling people to exercise (GET) and ‘think happy thoughts’ (CBT) is not a cure for ME. That is, the guidelines have gone some way to dispelling the notion that ME is a psychomatic condition. As The Canary previously reported, this goes against many people with vested interests in keeping ME as ‘all in people’s heads’:
the story of why exercise and CBT is pushed onto people who are chronically ill is two-fold. Firstly… it’s part of a drive by successive governments to use the NHS to force as many sick and disabled people back to work as possible… GET, CBT, and the idea that if those methods fail the patient isn’t trying hard enough, fits into this. The DWP [Department for Work and Pensions] and doctors can say ‘It’s your fault you’re still ill; therefore we won’t support you any more’. Peak corporate capitalism, you could say. Also, CBT is relatively cheap to deliver – so it’s a win-win in the age of austerity.
But as well as this, there is the “psychologisation” of physical illness…
This idea has been around for many years. Essentially, psychologisation means that when a doctor can’t find a physical cause for a person’s illness, then it must be psychiatric. That is, the person’s mental health is causing a physical illness; ‘psychosomatic‘ or, it is ‘all in their heads’.
The “psych lobby”
As we noted, many other illness and conditions aside from ME are now treated in the same way: that there is a psychological aspect as to why patients are so ill, and that they need psychiatry to get better. Historically, psychiatrists tried this on AIDS patients, among others.
In terms of ME, researchers who say GET and CBT work as a treatment have driven this idea. There’s a “boom” industry around treating physical illness with mental health approaches. And we’re now seeing the same for long Covid. As Sarah Graham wrote for iNews:
Already we’re seeing anecdotal reports from long Covid patients whose alarming and debilitating physical symptoms have been dismissed as “anxiety” or “stress”. Respiratory consultant Dr Asad Khan tells me he and others have been advised to “push through” their long Covid symptoms with exercise, despite the evidence that this approach is ineffective for similar energy limiting conditions like ME.
Meanwhile, the British Psychological Society proposed, and then withdrew, plans for “psychological screening that might predict long Covid”; seemingly retracting this after push-back from social media and its own member networks.
So, for NICE to undermine what some people call the “psych lobby” in the UK was always going to be contentious.
The finalised NICE guidelines are not without fault. You can read The Canary‘s full analysis of them here (when NICE published the draft version).
The Canary asked NICE for comment. We specifically wanted to know more about why it delayed both the publication of the guidelines and the round table event and what its criteria was for appointing members to the round table event and a general comment on the leak. A spokesperson told us:
We are aware of the level of interest from the myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome (ME/CFS) community and are bringing together representatives from patient organisations and charities, relevant professional societies and from NHS England and NHS Improvement, NICE and the guideline committee next month to discuss a way forward.
NICE is keen to move forwards as quickly as possible. However, we recognise that in order for the meeting to be effective, it is important to fully understand the issues and concerns that all groups attending wish to raise. We are also aware the difficulty of holding a meeting at short notice in September created for attendees who would have been unable to make the original date.
The roundtable event will have an independent chair and its aim is to allow us to better understand the issues raised and determine how to ensure effective implementation for the guideline.
We remain optimistic that we can reach a way forward to publish a guideline that will have the support of people living with ME/CFS, the people who care for them and the professionals who treat them.
NICE: “fatally flawed”
With the delay of the publication and the kick-back from some medical professionals, it’s clear that even NICE’s light-touch approach to altering views on ME was a step too far for some. And its delay in publishing the final guidelines have caused further anger and distress to an already traumatised community. Eliot-Smith told The Canary:
Four years ago, NICE began the process of updating the existing 2007 guideline for “ME/CFS”. Reports from those involved suggest that NICE has made great efforts to facilitate a fair and transparent process from the outset. However, that approach changed abruptly when general publication of the final version of the new guideline was “paused” at the eleventh hour on 17 August 2021.
The process was instantly thrown into chaos and confusion. Media reports suggest that this sudden change of attitude occurred as a result of external interference, something which NICE had previously resisted. Of even greater concern is the imposition of a complete information blackout on everything that takes place from now on.
Despite the wide discretion it enjoys as a public body, NICE has now sacrificed its independence. In the absence of an adequate explanation clarifying and justifying its extraordinary actions, the entire process has now become fatally flawed.
This leaves an already traumatised international ME patient community in a state of extreme distress with no end in sight to the long wait for a guideline which better reflects the devastating illness that many have lived with for decades.
A new guideline does not become operative unless and until it is published by NICE.
The purpose of [me] making this “final” version of the guideline available now is 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 that may be released at a later date.
It’s difficult to see how NICE can resolve this situation. Either it bows down to the “psych lobby” and completely discredits itself, or it become a rogue unit in the eyes of parts of the establishment. As Eliot-Smith wrote, its decision to delay publication could have huge implications:
- 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?
Moreover, NICE has eroded people’s trust in it. As journalist George Monbiot said, it:
has to decide whether it’s a science-based organisation, or whether it’s beholden to a lobby group that refuses to let go of dangerous and long-discredited quack “treatments” for ME/CFS. Its credibility hangs on the outcome.
There are wider issues too. Not least is that some frontline patient advocacy groups have signed gagging clauses in contracts with NICE process. It was so they could be stakeholders in the guideline process. But now, with the situation critical, these advocacy groups can no longer effectively advocate for people with ME.
Lobbying: infecting every corner of society
Ultimately, what the situation with NICE and the guidelines show is the power that’s exerted by a small group of people. In some respects, this is another example of how lobbying by people with vested interests infects every area of our democracy. But moreover, it represents a continuation of the abuse by the medical establishment towards people with ME; abuse they have suffered for decades. NICE seems either completely ambivalent to this, or intentionally exacerbating it.
Now, with the final guidance in the public domain – the next move is NICE’s. Will they capitulate to those who want ME and countless other illness psychologised? Or will the organisation stick to standards of rigour, evidence, and independence? At this point, it’s hard to tell either way.