We should have been welcoming the arrival of a completely new NICE guideline on ME/CFS today. A guideline that acknowledged ME/CFS as a serious and complex medical condition. In fact, we had sent an embargoed press release and statement from Forward-ME to all the news-media in anticipation of its publication.
It was a guideline that contained sensible advice on activity, energy, and symptom management – along with a revised timeline and advice for early and accurate diagnosis, and it placed special emphasis on the care and management of children and young people and those who have severe or very severe ME/CFS.
Instead, we are discussing the huge disappointment felt by the patient community to yesterday's announcement from NICE to cancel publication today and to pause proceedings while discussions take place around objections to the new recommendations regarding CBT and GET – objections that were discussed and resolved as part of the long review process.
On a personal basis, having spent a considerable amount of my time over the last four years working with colleagues on the preparation of this new guideline, I feel frustrated and angry. The action of a small number of people who have persuaded the leadership at the Royal College of Physicians, the Royal College of Paediatrics and Child Health, and possibly other Royal Colleges, to put pressure on NICE to reconsider what had already been agreed by the guideline committee, is reprehensible.
The delay is unprecedented
The guideline committee – comprised of experts, clinicians and patients – spent a huge amount of time mostly on a voluntary basis reviewing and discussing all relevant evidence relating to both safety and efficacy of both drug and non-drug treatments. This has included a very detailed review of all the published evidence from clinical trials, expert witness statements, and extensive patient evidence.
As a result, it was concluded that there is no sound evidence currently available to recommend any form of intervention (drug or non-drug) as a treatment for the underlying disease process in ME/CFS. And in the case of GET, the published research evidence was determined to be of low or very low quality, and there was compelling evidence of people not improving and even being harmed by this approach. For CBT there was no evidence that it was curative.
Stakeholders (amounting to over 200 professional bodies, charities, and groups) had ample opportunity to review and comment on the draft guideline at the end of last year. NICE and the committee reviewed all comments ahead of producing a final draft guideline earlier this month. The content of the final draft guideline should not have been a surprise to anyone.
The process by which NICE – an independent and evidence-based organisation whose recommendations provide a framework to health and social care provision – was the same for the ME/CFS guideline as it is for others. This delay, announced only 8 hours before we might have expected the new guideline, came as a shock to us all – including the committee members. It is unprecedented.
It is very difficult to understand why – after all this hard work, the extensive stakeholder consultation that has occurred, and a committee that reached a consensus decision in its recommendations to NICE – a small group of medical professionals still cannot accept the recommendations and now want to question the credibility of the guideline committee and seek to overrule to recommendations.
I am no longer a member of the guideline committee but I suspect that the next thing to happen will be for the committee to meet to discuss the situation. Until we know more about what is happening it is better to put any form of individual or charity action on hold. But there are clearly a number of options that could be considered.
The ME Association will continue to work with our colleagues at Forward-ME in relation to any further action – as it is very important for all the ME/CFS charities to be agreeing and working together at this very difficult time. I was intending to answer questions on the new guideline on Facebook today. I will continue to try and do so but as already noted, I may not have the answers to the questions that the community is asking.
Dr Charles Shepherd, Hon. Medical Adviser, ME Association