As NICE’s ‘pause’ in publishing the replacement guideline on the diagnosis and management of ME/CFS approaches 2 month in duration, Baroness Thornton raised the matter in the House of Lords on 12 October 2021.
To ask Her Majesty’s Government, further to the decision to delay the planned new guidelines on the diagnosis and management of ME/CFS, what assessment they have made of the ability of the National Institute for Health and Care Excellence to carry out its functions; and when they expect such guidance to be published.
The question was answered by newly-appointed Lord Kamall (Parliamentary Under-Secretary, Dept of Health and Social Care) which did little to advance matters other than state the current position.
NICE is seen as a world leader in the translation of research into authoritative, evidence-based clinical guidelines, and the Government have confidence in NICE’s ability to carry out its functions effectively. We all know that ME/CFS is a complex condition and, as we understand, a range of views about its management have been expressed during the development of the updated guidelines. To address as wide a range of views as possible, NICE is holding a round table with stakeholders next Monday to discuss these issues and will then take a decision on the next steps.Hansard – House of Lords 12th October 2021
In replying, Baroness Thornton pressed the government spokesman by making the point that the public must have confidence in NICE’s methodology and, indeed, NICE must have confidence in its own processes. “If the Minister says that the Government have confidence in NICE, it begs the question why the Government are not demanding that the ME/CFS guidance, three years in the writing and with patient support, is not being published immediately.” She then pressed the argument adding “GET is the current medical treatment regime for ME/CFS sufferers, which these guidelines say should be reformed. Did NICE come under pressure to pull these guidelines because of medical vested interests in the delivery of GET, particularly since they believe that this is the treatment for long Covid?”
Lord Kamall responded
… the NICE guidelines were delayed twice. They were first delayed because it wanted to make sure that it had taken on board all the various submissions that had been made; they were delayed a second time because, just as they were about to be announced, concerns were raised by clinicians and other stakeholders. If you are going to have guidelines, it is important that they are accepted and recognised by as wide a range of stakeholders as possible; otherwise, they might lose their authority.
We want to make sure that, whenever we have this situation and there are people with a range of views, we get them around a table and have a conversation, as common sense tells us, to see if we can agree on a way forward. I very much hope that, once we have had this round table, we will be able to agree a way forward.
The response failed to answer the questions and glossed over the facts that all stakeholders were invited to provide best evidence to NICE and that the finalised guideline was circulated in early August at which point the evidence gathering/assessment process was complete. NICE had taken account of all views whilst preparing the finalised text and so the guideline was already the result of informed discussion based on evidence. Baroness Finlay of Llandaff (declaring an interest as she served as vice-chair of NICE’s ME/CFS guidance review committee) made these very points when she informed the House that the guideline was arrived at “through consensus agreement in the committee. This was fully compliant with NICE’s rigorous processes.” and urged the government to work with commissioners to ensure that appropriate specialist services for patients with ME are developed and continue, and that services monitor accounts of harms as well as benefits.
Other Noble Lords joined the debate and made interesting points. Lord Bethell asked “… does the Minister accept that this (long-COVID) shines a clear spotlight on how far behind and wrongheaded we are with the diagnosis and management of ME and CFS?” and Baroness Scott of Needham Market asked “Does the Minister accept that the prevailing view in some quarters that ME is a psychological disease is causing untold harm, including to children and young people, who are being forced to accept treatments which are damaging to them, and to their parents, who are sometimes accused of abuse? Taking time to achieve consensus is one thing, but the Minister should be aware that there is a huge cost to this.”
Alas, Lord Kamall either failed to answer – and it is lamentable that he did not comment on the ‘psychological’ issue – or slipped into the matra that consensus was needed.
Baroness Ritchie of Downpartick, attempting to tease out the reasons for the delay, asked “My Lords, what issues were raised during the pre-publication period for the final guidelines which merited a pause in publication?” to which Lord Kamall answered
The issues related to some of the guidelines concerning GET. There was a concern that these would be deleted. Some groups and stakeholders expressed the concern that, while some patients clearly found these damaging, others might find them helpful, or partly helpful—not as a cure in themselves but as part of their treatment. That is why NICE convened this roundtable to ensure that it hears a wide range of views. Hopefully, this can achieve some sort of consensus and help stakeholders to understand where others are coming from, so that some sort of agreement can be reached.
As the publication of the NICE guideline has been paused for operational reasons after, as Baroness Finlay of Llandaff stated, the full process of evaluating evidence – what are the objecting parties proposing? That ‘treatments’ are continued to be offered that NICE have found are not supported by evidence? That the objectors have evidence of efficacy but failed to submit it or felt that their evidence was more deserving of respect than it received? It will be recalled that the November 2020 draft guidance (sections 1.11.15 to 1.11.22) does permit physical activity programmes for those “who are ready to progress their physical activity beyond their current activities of daily living, or would like to incorporate physical activity into the management of their ME/CFS” and so it is a fallacy to claim that if thought that GET possibly may no longer to be recommended by NICE that no exercise plans are permitted.
When Baroness Cumberlege reminded Lord Kamall that “Patients have been dismissed, ignored and not believed, and the majority of them are women. Can my noble friend give an assurance that women will be listened to and not treated in the way that many of us, men and women, have found appalling?” the Under-Secretary stated that
It is absolutely right that we praise our health service when it does well, but we should also be able to acknowledge when mistakes are made or when patients do not receive the kind of service we expect them to. It is important that my noble friend and others push me, as the Minister, and the Department of Health and Social Care to make sure that we are addressing the genuine needs of patients and that patients are not ignored. I pledge that I will be a champion of patients.
His ‘answers’ to the queries do not reflect any of the sentiments in his closing remarks and lack insight into the history of ME/CFS and the treatment of patients by some within the medical community.