Many people awoke on 18th August to headlines in newspapers, listened to Radio 4’s Today programme, and even noticed a story on the ‘red button’ which covered the news that a NICE guideline publication into ME had been ‘paused’ only hours before its release. The gist being that ME charities were baffled and/or angry and certain professors and members of some Royal Colleges apparently relieved. To those not within the ME bubble (and several within it) must have wondered what was happening.
It is a story long in the telling – dating back to 2007 when NICE published its first guideline (the guideline is the standard by which healthcare professionals are to approach an illness; diagnose; treat; and support those affected by it) into CFS/ME and crystallised a divergence in views on how the illness was diagnosed and its basis. The fact that it used the term CFS/ME which conflates a physical illness M.E. with a syndrome (a combination of symptoms) – Chronic Fatigue, perhaps indicates where NICE’s thoughts were more than a decade ago. Broadly, there were those who felt the symptoms of the illness were either a manifestation of or were perpetuated by the mind of the patient. To others the illness had a physical cause, effects, and ought to be treated as such. On thin evidence, NICE decided that “cognitive behavioural therapy (CBT) and/or graded exercise therapy (GET) should be offered” to patients. Fast forward 10 years (to Sept 2017) and NICE announced a review of the guideline. A committee was formed, NICE appointed its members drawn for clinicians, researchers, physiotherapists and patients, evidence was called for, examined, weighed, additional evidence called for, and then a draft produced and comments and additional evidence invited. All parties had an equal opportunity to place the best research available before the committee then duly weighed it in terms of NICE’s normal practice.
Two major points emerged when, in Nov 2020, a draft was produced for comment. The draft indicated that NICE accepted the evidence that CBT could be offered, as it is in other conditions, to aid coping with symptoms and of having a chronic, limiting illness but was not a cure. NICE also indicated that GET was not to be used. The finalised version was released to all stakeholders 14 days before the date of publication – and, according to NICE’s guideline manual (s12.2.3) this documentation “is not an opportunity to comment further on the guideline” – but to allow information to be amassed, websites updated, and advice prepared. Then, a matter of hours before the embargo ended, NICE delayed publication.
It is unknown exactly what representations were made to NICE during the crucial fortnight between the finalised draft being released and the ‘pause’ or by whom. Even stakeholders and committee members are not aware but the effect is that a guideline (2007) whose terms were rejected by NICE remains in force and a route entirely without parallel if being devised to accommodate the wishes of sectoral interests. The issue was that most NHS clinics offered CBT and GET and many within the medical profession cling to a psychosocial (or bio-psychosocial model) of the illness and so professional lives and careers are predicated on an understanding of the illness and on treatments which NICE was rejecting or, at least, undermining. NHS clinics offer CBT and GET – down grade these and what do the clinics and clinicians offer?
Let us not think that NICE’s 2021 recommendations were revolutionary. They are based on the information supplied to them and as was commented on by Michiel Thack “NICE is far from the only healthcare institution that downgraded the quality of evidence for GET or CBT. The Health Council of both Belgium and the Netherlands recently came to similar conclusions. In the US, the website of the Centers for Disease Control and Prevention (CDC) no longer recommends GET or CBT for patients with ME/CFS. Cochrane is currently updating its review on GET for ME/CFS after an internal review clarified that the evidence has multiple limitations.”
CBT could still be offered but not as a treatment for the illness and the final document set out in a number of pages (way beyond what is normal in other illnesses) how CBT was to be used. Exercise and energy management strategies could still be a feature of a clinic’s work but fixed incremental strategies – GET – were not to be used. This definition is a reflection of the PACE trial definition.
To the morning of 18th August then and quote from – Dr Alastair Miller, Consultant Physician in Infectious Disease and Internal Medicine, on the Science Media Centre website : “The draft guidelines were predicted to stop the use of GET and limit the use of CBT which have served most CFS/ME clinicians and patients well for many years and were endorsed by the NICE guidelines in 2007. Most NHS clinicians use GET and CBT and have done so for a long time.” Note – they served the clinicians well is the first refrain. The fact that it has taken 14 years for NICE to review the ‘treatments’ ought not be a vindication of their efficacy but an indictment of a system slow to react as contra-evidence builds.
“Importantly, without CBT and GET, there is nothing. No new therapies or approaches have emerged since 2007 (so in practice one needs to question whether there was ever a requirement to have a new guideline)” This ignores totally that NICE decided to modify the advice because the underlying evidence for their use was weak and other evidence was led of risks associated with GET. Those advocating NICE were able, and did, submit their evidence of the effectiveness of CBT and GET but NICE (not charities or patient groups) drafted the guideline in light of world-wide knowledge. It ought to be remembered that NICE would look at efficacy and safety to be proved – not disproved. Merely because X was in the guideline in 2007 does not mean that evidence must be led to overturn it – evidence needed to be made to keep it and weighed against the contrary evidence. Clearly, they failed.
The fact that there are no new cures or therapies is an indictment on the lack of research into the illness since 2007. Of the funds made available , prior to deCodeME, these went to those trying to prove the efficacy of GET (the PACE trial) and such has the findings been undermined that NICE obviously rated its lowly.
So, are ineffectual and potentially harmful therapies to continue for the convenience of clinicians, their careers, and to keep their clinics busy? No mention that CBT and energy management strategies were to continue or be substituted. The benefits reported by the clinics to some patients from supervised, appropriate exercise, contained within a patient-centred plan and mindful of adverse reaction are not banned.
Dr Miller then states ““It is difficult to say where we go from here. There are some amongst the charities and patient groups that are utterly opposed to CBT and GET and so compromise and consensus may be difficult to achieve.” Yet, it is not the charities who got NICE to pause the process and overturn its norms – when would those railing against NICE compromise and what consensus would they accept?
How can NICE proceed if it has, as it says, an evidence-based process? It stands with a draft produced after a long and rigorous process that everyone was able to take participate. If NICE deviates then it does so on basis of compromising its integrity in the face of a vested interest acting without evidential support and perhaps advocating procedures which harm some patients. It is hard to think of another illness in which this situation would arise and perhaps it shows that vested interests are so concerned that their grip is loosening that this is viewed as a totemic fight they cannot, for reputational reasons, loose lest they may need to admit the unpalatable truth – that they were wrong about ME/CFS being ‘all in the mind’.