NICE : a Reply Regarding my letter to Sir Andrew Dillon

 Stonebird
Greg Crowhurst Aug 30th 2017

On July 27, I wrote to Sir Andrew Dillon re Myalgic Encephalomyelitis. This is NICE’s reply, dated 29th August. 

I have added the  questions I asked and made some brief comments.

Thank you for contacting the National Institute for Health and Care Excellence (NICE) regarding our guideline on chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management (CG53), Sir Andrew Dillon has asked the corporate communications team to respond on his behalf.

I appreciate that this is an important matter for you and I have addressed of your questions in turn below.

In March this year we advised you by email that we were unable to comment on how another organisation interprets our guideline and this is still the case. If the JCPMH have referred to our guideline in a different way then you would need to take this point up with them directly, NICE is unable to get involved.

Comment: Despite my best efforts, letters to the Department of Health, NICE, the Royal Colleges themselves, there seems to be no formal mechanism for holding the Royal Colleges to account. It is extremely concerning that the JCPMH have been able to inform Commissioners that ME is a mental disorder, with apparent impunity.


Question 1.

GC : Can you tell me why NICE itself lists ME under "Depression and anxiety disorders" on the IAPT webpage and can you reassure me that it will be removed? That surely is as great a misrepresentation of ME as the JCPMH document, especially given the recognition in CG53 that “ the physical symptoms can be as disabling as multiple sclerosis, systemic lupus erythematosus and congestive heart failure .”

NICE : I can confirm that on the NICE website www.nice.org.uk we haven’t listed myalgic encephalomyelitis as a topic under depression and anxiety. We do not have this as a sub heading on the website, depression and anxiety are listed as two separate topics and our clinical guideline on chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) (CFS/ME) is listed under a separate sub heading of ‘chronic fatigue syndrome’.

NICE does not manage the Improving Access to Psychological Therapies (IAPT) programme this is run by NHS England so we have had no input in determining which conditions are covered by the programme and how they are categorised on the website. I would suggest you contact NHS England for further assistance. It is listed on the NICE page on identifying and assessing digitally enabled therapies because it is included in the conditions covered by the IAPT programme.

Comment : The ME Community needs to take this up with NHS England, however there is an underlying issue here, it is much complicated than it appears and needs  further addressing with NICE.


Question 2.

GC : Can you explain the nature of IAPT’s involvement in ME, especially in light of the the CDC’s recent decision not to recommend CBT and GET? http://www.meassociation.org.uk/2017/07/cdc-removes-cbt-and-get-as-recommended-treatments-for-mecfs-11-july-2017/


NICE : As discussed above you would need to speak to NHS England directly as to their involvement in CFS/ME. NICE has not asked the IAPT programme to manage the implementation of the guideline on CFS/ME on behalf of NHS England.

Comment : Another issue that must be followed up with NHS England.

Question 3.

GC: Can you tell me what role, if any, IAPT played in the drafting of the recent CG53 Surveillance Document, which has been heavily criticised by all major ME Charities and thousands of patients for:
  •  its adherence to the widely disputed CBT/GET paradigm, which has been shown to make patients, especially the most severely affected, much worse. http://stonebird.co.uk/psurvey.pdf
  •  its many references to the universally discredited PACE Trial
  • its reliance upon vague diagnostic criteria that do not clearly identify or separate ME from mental health Chronic Fatigue (WHO F48)A wide definition helps no one; surely it is time to acknowledge that ?
  •  its scant regard for biomedical evidence
  • · its extraordinary decision not to update the 10 year old guidance which not only was condemned as “unfit for purpose” at the time, but continue to deny patients, like my profoundly physically ill wife, equal access to health care
  • its failure to accurately represent international clinical practice
  •  its failure to remove outdated treatment recommendations and its pronounced self-circular psychiatric bias.


NICE : IAPT have not been involved in drafting the surveillance review for CG53.

With regards to the PACE trial our guideline was published in 2007, before the PACE trial and was therefore not based on its results. It drew on an overview of the research available up to 2007.

In 2011, we looked very carefully at the relevance of the PACE trial and whether the results necessitated an update to the guideline. We concluded that the results were relevant but would be unlikely to substantially change the recommendations and so we decided not to update the guidance at that time. You can find the full details of the comments we received relating to the PACE trial and our conclusions during our consultation on whether we needed to review and update the guideline on the website.

We haven’t made a decision on whether the guidelines should or shouldn’t be updated at this point, the provisional review decision published does not constitute NICE's formal decision on this guideline. The decision is provisional and may change after consultation. Comments received during consultation will be considered and further information will be available on the website in due course.

Comment : There are many, many issues here regarding NICE’s reliance upon a weak, flawed evidence base, its controversial Consensus methodology and its refusal to accept the WHO International classification.

Question 4.

GC: I am very curious to know the composition of the Topic Experts and their knowledge base and impartiality. What biomedical representation, if any, did you have? What clinical input, outside of the biopsychosocial school, was involved for unbiased appraisal of the biopsychosocial content? Can you tell me who the Topic Experts were? Were any of the Royal College’s involved?

NICE : Topic experts and members of the original guideline committee are asked for their opinion, in their personal capacity, on the relevance of the published guideline, recent developments in the topic area and their knowledge of any new important evidence since publication of the guideline. Guideline committees are responsible for the recommendations made and we publish the membership of them. We do not routinely publish the identities of topic experts because while they may express an opinion they are not part of the decision making body. However, I can tell you that  the topic experts are from the following fields: neurology (2), psychiatry (3), paediatrics (1), patient representative (1). NICE’s surveillance review team summarises the relevant evidence and highlights any studies that may have an important impact on our recommendations. The main themes of new, relevant evidence across the guideline are also summarised, along with any other identified information (such as changes in licensing indications for a medicine or updated national policy). The surveillance team is made up of NICE employees - a Technical Analyst, Technical Adviser, Clinical Adviser and Associate Director.

Comment : There are huge concerns  regarding the unbalanced make-up of the GDC; which was overwhelmingly psychiatrically biased.
Question 5.

GC: Can you tell me why NICE only gave stakeholders two weeks to respond to the 56 page Surveillance document, making it incredibly difficult for those people who have ME themselves or full time carers, to have enough time to contribute adequately or at all.

NICE : As per our methods and process which are published in our developing NICE guidelines: the manual there is a standard 2-week consultation with stakeholders who are registered for the published guideline when information summarised at the 4-year and 8-year checks (and at every 4-year check thereafter) indicates that a 'no update' decision should be considered.


Question 6.

GC: Can you explain why NICE has relied heavily on an unfounded psychiatric theory of ME that is nothing more than that, with no real evidence itself, while ignoring the more than 9000 published papers that have been published world wide, detailing the biomedical abnormalities in ME?

NICE: When we develop a guideline our process is that we first screen abstracts against inclusion criteria, but then we assess the selected studies and read them in full. How we develop our guidelines can be read in more detail on the in ‘developing NICE guidelines: the manual’ on our website. Section 6 ‘reviewing the research evidence’ is the section that explains how we review studies in more detail.


Comment: There are  numerous  issues relating to how NICE failed, time and again, to adhere to its own Guidance, in drafting CG53.

Question 7.

Can you explain, given the statement in 2014 by Professor Mark Baker, Director of the Centre for Clinical Practice, at a Forward- ME meeting, that the Guideline failed to address the real issues in ME/CFS, does not promote innovation and has had a disappointing impact on specialist care and commissioning issues, why NICE has continued to stick to its outmoded, inappropriate, dangerous guidance?


The Surveillance document does nothing, in my opinion, to challenge the misperception that ME is a mental illness, in fact it's decision to come off the static list, not for medical reasons, but because of the FITNET CBT/GET Trial reinforces the apparent psychosocial bias of the whole document and attitude of NICE.
If CG53 continues to contribute to a situation where people with ME are:

  • misinterpreted as having a mental health issue
  •  where biomarkers are not sought for and relevant tests are proscribed
  • where health professionals of every level are misinformed and their awareness skewed wrongly towards a biopsychosocial interpretation of a serious physical disease with ignored multi-system dysfunction, endangering lives and leading to mistreatment, misinterpretation, neglect and harm
  • where the guidance on Severe ME fails to recognise the terrible suffering and multiple physical symptoms patients experience, making it dangerously irresponsible. http://www.stonebird.co.uk/principles of care.pdf
  •  where ME is still not separated from and confused with mental health Chronic Fatigue and other poorly diagnosed diseases
  •  where services are geared towards a psychiatric diagnosis of wrong illness thought and deconditioning
  •  where patients are offered treatments that are inhuman, cruel, inappropriate and dangerous, because they are in direct denial of their physical reality- the potential for harm is enormous and terrifying in ME

then surely that is in contravention of your obligations under the Human Rights Act and the Equality Act?

The ME Community has been insisting for years that CG53 is not and never has been appropriate for patients with Myalgic Encephalomyelitis; the way forward is for ME to have its own biomedical Guideline and pathway, categorically without psychiatric interpretation and involvement.

NICE: Unfortunately it would appear that Professor Baker’s comments during the meeting in 2014 were misunderstood. We maintain full support for the guideline, it remains the most balanced and sensible exposition of the treatment options.

Comment : “Balanced and sensible”, according to whom ? How exactly can the Guideline be considered “balanced and sensible” if it does not take into account either the voices of patients, medical experts and medical evidence ?

 However we are aware of the ongoing concerns of patients and CFS/ME groups (such as Forward ME) regarding the level of research into these conditions, inconsistencies in the implementation of our recommendations, the lack of services and treatments, and the support available for patients, on which we have received numerous comments since publication of the guideline in 2007. All of these are outside the remit of NICE, and although we can acknowledge such concerns as Professor Baker did in the meeting, it would be inappropriate for NICE to comment further.

We are aware of and understand the depth of feeling about the options for treatment of those living with this condition. We also know that strong views on the need for the guideline to be updated are held by many people. Having taken a provisional position on the need to update our recommendations, based on our reading of the evidence that has emerged since the it was first published, we will consider the results of the consultation. I can assure you that we will take into account the reasoned arguments put to us.

Comment: There are many issues, unanswered, still to be raised with NICE. Let us hope, however, from this letter, that we will be heard and that the Guideline will be updated.


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