In December 2012 the NICE Board agreed that a new programme for reviewing clinical guidelines should be developed.

As part of that proposal NICE decided to create a list of candidates to put on a static list to ensure sustainability and efficiency of the programme.

In August 2013 NICE’s Senior Management Team (SMT) agreed the first list of candidate topics for stakeholder consultation.

This included CFS/ME. NICE recently contacted registered stakeholders requesting comments the NICE decision to transfer 27 clinical guidelines onto a static list [1] and [2].

Comments were requested to be returned 5pm on 23rd October 2013.

IiME Comments

The original NICE guidelines were almost unanimously rejected by patient organisations [3].

A review was initiated in 2010 [4].

The original NICE CFS/ME guideline put forward a psychosocial model for ME and promoted CBT and GET as the options for management. The biological model with evidence of inflammatory, immune, oxidative and nitrostative pathways as key areas was ignored. This was heavily criticised [6].

The AGREE Instrument (Appraisal of Guidelines Research and Evaluation Instrument) with which NICE is obliged to comply in the formulation of all its Guidelines is specific: “The health benefits, side effects and risks should be considered when formulating the recommendations”.

NICE failed to conform to the AGREE Instrument which requires that NICE is obliged to give equal weight to three main sources of data: “evidence-based” medicine, usually deemed to be random controlled trials (RCTs); the opinion and experience of physicians with expertise in the area, and the opinion and experience of the patient group for whom the Guideline is intended.

NICE did not abide by the European AGREE standards which govern guideline development.

IiME rejected the original NICE guidelines as unfit [5].

IiME recommended a review in 2010.

We again urge NICE to initiate a complete review of guidelines for ME.

NICE have previously exhibited a poverty of intent and reason with regard to treatment.

Although we doubt whether NICE will change its attitude (NICE has shown scant regard in the past to the concerns of ME patients and their families) we have nevertheless used the opportunity to draw attention to the following points -

  • IiME concluded that the basis of the NICE Guidelines was in viewing as broad a section of fatigue states as possible, where high quality biomedical research into ME was ignored. Essential research showing the multi-system nature of ME was not considered or discussed.

  • The original guidelines were unfit.

  • The prevalence figures used by NICE are at odds with recently announced prevalence figures used by the MRC collaborative and recently NIHR-funded research - with a difference of over 100%. This means we have an epidemic of ME or the NICE figures are completely wrong, or the MRC collaborative figures are completely wrong

  • NICE exhibited a bias toward promoting a predetermined one-size fits all approach to ME by continually highlighting CBT and GET therapies despite widespread derision from ME patients.

  • New research underway and planned to be completed in the next three years invalidates NICE's statement that no new research is expected to change their decision [7]

  • To leave the current outdated and unusable NICE guidelines for ME for another 5 years with no updates reflecting the current poor education regarding ME and without any knowledge of the biomedical research performed/about to be performed, would effectively mean that no clinical guidelines for ME will have been reviewed for 12 years. That is unacceptable.

  • The PACE Trial has demonstrably proven that CBT and GET (the primary treatment recommendations of the NICE guidelines) do not work.

IiME's response was sent in on 23rd October 2013 [2] using the required NICE pro-forma.

The submission is available here -

February 2014 Update:

In February 2014 NICE published their responses. These can be viewed here

The responses to Invest in ME's comments are from page 95 onwards.

We find the NICE comments both meaningless, inaccurate but also pre-determined.

NICE claims to be "transparent in its development, consistent, reliable and based on a rigorous development process".

For ME we feel NICE fails in these aims and falls short of an organisation whose role patients' futures.

When such a body mismanages its obligations and ignores patients then it is surely time for it to be changed or removed.


  1. NICE Clinical Guidelines proposed static list consultation
  2. Interim clinical guideline surveillance process and methods guide 2013
  3. NICE Guidelines - What Next?
  4. IiME Response to NICE Guidelines
  5. IiME Page for NICE
  6. Comments from experienced ME clinicians and researchers - click here
  7. The Right Stuff
  8. IiME Response to NICE October 2013

Last Update October 2013