Removal of GET from NICE Guidelines
Correspondence with Dr Paul Chrisp - Centre for Guidelines Director, National Institute for Health and Care Excellence
Invest in ME Research is currently reviewing the draft guidelines for ME document from NICE.
Whilst reviewing the NICE draft guidelines it has, in our opinion, been necessary to repeat one request to NICE which we feel cannot await the results of the NICE guidelines review.
We have therefore written to the NICE Guidelines Director- as detailed below.
Initial letter to Dr Paul Chrisp 16 Nov 2020
NICE Guidelines for Myalgic Encephalomyelitis (ME)
16 November 2020
Dear Dr Chrisp,
Invest in ME Research is a UK charity (charity nr 1153730) that seeks to educate and campaigns for biomedical research into myalgic encephalomyelitis (ME). The charity also facilitates and funds biomedical research into ME.
Invest in ME Research is a stakeholder in the NICE Guidelines review process for ME, and is currently reviewing the recently published draft guidelines .
However, we feel there is an urgent matter that needs to be addressed immediately.
This concerns the continuing recommendation for use of Graded Exercise Therapy (GET) for ME that is currently retained in the current NICE Guidelines for ME (CG53) and still standing as a recommendation for doctors treating people with ME.
In correspondence with Professor Mark Baker (NICE Guidelines Director) in 2018  we had requested that NICE remove the recommendations for CBT and GET immediately from the existing guidelines due to the deleterious effects on people with ME.
In our correspondence Professor Baker agreed that GET was perceived and experienced by patients as harmful and we believe that Professor Baker accepted the claims that patients have been harmed by GET.
Professor Baker declined our request to remove GET at that time but responded –
“I appreciate that the existing recommendations are a matter of concern to some patients and groups and we will give some consideration to whether we need to modify or omit any of the existing recommendations during the development of the new guideline.”
Well, now the development of the new guideline has reported that GET should no longer be used as a recommended treatment of ME.
Therefore, there is no excuse to retain GET as a recommendation when nobody wants it, including your guidelines review team. There is no longer any argument for delaying an immediate removal of GET from the current guidelines and informing all GPs and healthcare providers that GET should not be recommended for ME.
As we suggested to Professor Baker this can be achieved via an addendum to the existing guidelines and via the routine warning system that NICE employs, via your web site and social media (as you have done for covid-19 ).
The final version of the guidelines for ME will only be published in April next year and we feel that it would be negligent to leave a dangerous recommendation in place for yet another six months.
NICE ought to be accountable for any for damages, and costs, relating to the burden and harm brought on to patients by retaining this erroneous and negligent recommendation for a moment longer than necessary.
We hope that you will decide to take action on this urgent matter.
Thank you for taking the time to consider this request,
Chairman Invest in ME Research
and the Trustees of Invest in ME Research
Reply 27 Nov 2020 from Dr Paul Chrisp, NICE Guidelines
Dear Ms McCall
Thank you for your email.
I understand that you are concerned about the recommendations on graded exercise therapy (GET) in our clinical guideline on chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management [CG53]. You also refer to our statement on graded exercise therapy (GET) in the context of COVID-19.
We understand the importance of up-to-date recommendations on treatments for people with ME/CFS. As you are aware the guideline is currently being fully updated and I hope that you will take the opportunity to submit your comments to the consultation.
In the meantime all of the recommendations in CG53 remain, there is no intention to remove the current recommendations on GET as this would be outside of our processes.
In terms of the statement on our website. This is not intended to imply any judgement on the safety of any of the recommendations in the ME guideline if applied to patients with post-COVID-19 fatigue. As NICE has not yet published any recommendations for the management of post-COVID-19 fatigue, we cannot make a judgement on what may or may not be effective in people with this condition. The intention of our statement is to clarify that the recommendations in the ME/CFS guideline should not be applied to people with post-COVID-19 fatigue as they do not fall within the scope.
NICE is working jointly with SIGN (The Scottish Intercollegiate Guidelines Network) and the Royal College of General Practitioners to develop a guideline on the management of the long term effects of COVID-19, including fatigue, which we expect to publish by the end of the year.
Dr Paul Chrisp
Director, NICE centre for guidelines
National Institute for Health and Care Excellence
IiMER Comment 29 Nov 2020
The reply from Dr Chrisp is not only disappointing.
We consider it shows a worrying continuation that NICE still do not seem to respond either to patients' concerns or to possible a negligent state that continues to be maintained where vulnerable and sick people may be left in a position where they can be harmed.
Look at comments from NICE through the years -
2007 The press statement from Professor Peter Littlejohns, NICE Clinical and Public Health Director
“This result is very good news for the thousands of people with CFS/ME, who can continue to benefit from evidence-based diagnosis, management and care for this disabling condition. The 2007 guideline was welcomed by patient groups as an important opportunity to change the previous situation for the better, helping ensure that everyone with CFS/ME has access to care appropriate for the individual. Today's decision means that the NICE guideline is the gold standard for best practice in managing CFS/ME."
After ME patients took NICE to a judicial review following patient criticism of the 2007 NICE guidelines for ME (click here).
2018 Professor Mark Baker, Centre for Guidelines Director, NICE
“I appreciate that the existing recommendations are a matter of concern to some patients and groups and we will give some consideration to whether we need to modify or omit any of the existing recommendations during the development of the new guideline.
Letters from Invest in ME Research to Professor Baker (click here).
2020 NICE - Statement about graded exercise therapy in the context of COVID-19
"NICE is aware of concerns about graded exercise therapy (GET) for people who are recovering from COVID-19. NICE’s guideline on ME/CFS (CG53) was published in 2007, many years before the current pandemic and it should not be assumed that the recommendations apply to people with fatigue following COVID-19."
COVID-19, NICE and ME (click here).
2020 Myalgic encephalomyelitis/chronic fatigue syndrome: diagnosis and management - Draft for consultation, November 2020
"In developing more specific recommendations on the content, approach and delivery of physical activity management, 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."
COVID-19, NICE and ME (click here).
And now November 2020 -
2020 Dr Paul Chrisp, Director of the Centre for Guidelines, NICE
“..all of the recommendations in CG53 remain, there is no intention to remove the current recommendations on GET as this would be outside of our processes."
So, in 2007 NICE were lauding the guidelines as gold standard - having accepted the "evidence", such as it was, as validating their recommendation for GET.
Roll forward to 2020 and NICE publish their draft guidelines for ME confirming that there is no credible evidence for GET to be used with ME and are calling for it to be removed as a recommendation.
Despite nothing changing in thirteen years it seems that the 2007 evidence is no longer held to be credible - something we have been stating for thirteen years.
Professor Littlejohn's gold standard guidelines of 2007 are now seen for what they were - a lamentable attempt to protect vested interests instead of patients' lives.
And yet, despite the potential harm, NICE still cannot see any reason to remove this flawed recommendation immediately.