10 year surveillance (2017) – Chronic fatigue syndrome/myalgic encephalomyelitis (2007) NICE guideline CG53
Response by Invest in ME - First Thoughts
Invest in ME Research have submitted a response to the request for comments on the
NICE guideline on CG53 Chronic fatigue syndrome/myalgic encephalomyelitis: diagnosis and management
Surveillance proposal consultation document
Our response is here 
A more legible document containing our response is available here
Invest in ME Research submitted a response in excess of 8000 words after analysing the document thoroughly.
NICE have decided "to not update the NICE guideline on chronic fatigue syndrome/myalgic encephalomyelitis" at this time.
NICE propose to remove the guideline from the static list because:
" Evidence has been identified of important ongoing research in this area –
for example a UK trial of internet-based cognitive behavioural therapy in children and young adults (FITNET).
This guideline therefore no longer meets the static list criteria.
NICE also state -
We propose to liaise with Cochrane about the possibility of updating a Cochrane review from 2008 on cognitive behavioural therapy for chronic fatigue syndrome in adults to include data from the ‘Pacing, graded Activity, and Cognitive behaviour therapy; a randomised Evaluation’ (PACE) trial. A further review of the guideline may be considered following publication of the updated Cochrane review.
Firstly it should be remembered that NICE gave Invest in ME Research only two weeks to make these comments - with a very short period beforehand of notification.
This, of course, potentially skews the results as we are certain that NICE has probably already informed other parties in the establishment long before of the process and far more time to prepare.
We have no faith in NICE. It is another establishment organisation that is going against what patients need and want and going against the trend to look at ME seriously and develop appropriate guidelines.
We found this a flawed and biased document which seems to cover a cynical attempt at manipulating
the future for people with ME and their families.
Background
Firstly some background.
When conducting this review NICE assume they are starting from a standing point of having a set of guidelines which were accepted and which now need to be reviewed.
The NICE guidelines were not accepted!
NICE were taken to a Judicial Review – by Patients – the very people that these guidelines should serve.
So a discussion on updating the guidelines cannot assume that the existing version is acceptable.
Having been made in 2007, and against a hostile response for ME patients and their carers due to the unsatisfactory approach taken by NICE,
it would seem obvious that an update is necessary.
A Pre-determined Response to a Scandal in UK Healthcare
The NICE Surveillance proposal consultation document is a disappointing document.
This review by NICE, already seemingly pre-determined by influential forces that NICE decline to name, mean that this judgement is not acceptable now.
This consultation review document is essentially worthless other than to recognise how little NICE has changed in 10 years and how immoral are the policies of NICE with regard to ME.
It is clear even from comments by Dr Martin McShane and Dr Clare Gerada in recent years at events organised by Invest in ME Research - after the NICE guidelines were published - that the NICE guidelines have not achieved any improvement in the quality of the lives of people with ME.
People suffering from this disease can also testify to that.
Services for ME patients are poor, misunderstanding and misinformation about the
disease continues (both in healthcare, government departments and by a fickle and heavily influenced media),
and doctors continue to know little about the disease.
This is compounded by the fact that flawed research continues to be funded by a biased Medical Research Council – thus limiting any progress for patients.
And in this picture NICE contribute to the mess by basing their decisions on biased information, ignoring evidence from USA and avoiding inclusion of promising biomedical research from Norway.
The NICE guidelines were written in 2007 and now it is 2017 so it cannot be so that everything stays the same.
The NICE guidelines need to be rewritten – or certainly updated.
It was Professor Mark Baker, director of NICE in 2014, who said in a Forward-ME meeting ( - he had been in post for two years at that time) -
" Turning to the ME/CFS Guideline specifically, the Professor said that it did not meet our needs and it did not meet theirs (NICE’s) either. "
A new Surveillance proposal consultation needs to be performed – this time with patient representatives – or the guidelines need to be dropped and a new set created.
This will be embarrassing for NICE – but that is too bad.
Far better to produce guidelines that are truly representative of the disease and of current valid research than produce something which continues to set doctor against patient and achieves nothing to help people suffering from this disease.
If NICE continue to publish corrupted guidelines and
recommendations and continue to try to hide a hidden agenda and make the situation
worse for people with ME and their families then NICE have to become accountable.
CBT/GET have been proven to be based on non-science for ME and should be removed from any recommendations in the guideline.
No other neurological patients are given CBT and GET as their primary treatment/advice.
Those who need psychological services (no matter what disease they have) can be refererred to such services but it should not be a blanket recommendation as it is with ME.
Most of the references from NICE add nothing to the future of people with ME.
Meaningless “research” is given far too much space – research that has made no difference to ME patients.
The NICE consultation document is even worse than the original guidelines. We have gone backward since 2007.
NICE ignore what seems to suit their pre-determined agenda for this consultation such as
reports from NIH and CDC which state that Oxford criteria should be retired (and thereby effectively
invalidating any research into ME performed using those criteria), that CBT and GET should not be used.
It ought to be obvious to all by now that the Oxford criteria cannot be used for research into ME and therefore any research based on use of Oxford needs to be removed and ignored.
This therefore makes the NICE review document invalid.
Yet NICE continue to argue for their retention and for the retention of the flawed research based on those
guidelines - guidelines now thoroughly rejected by rational academics and USA institutions such as NIH and CDC.
NICE self-select anonymous Topic Experts.
NICE has stated that it involves patients.
Was this the case in this Surveillance team?
Our feeling is that it is clearly not doing that, and is ignoring completely the concerns of people with ME and their families.
Giving a charity such as Invest in ME Research only two weeks to rebut this review is pathetic and NICE know this.
How much time was given to Topic Experts, or to others who try to influence NICE to maintain a Biopsychosocial bias?
The parrot repetition of the comment “New evidence is unlikely to impact on the guideline.” is gross negligence from an organisation that has pre-determined the result, given inadequate time for ME patient stakeholders to respond and clearly has no interest in learning anything from patients.
No matter how many times the flawed PACE Trial is proven to be unusable it is evident that NICE
will not let go of it in order to prove its policy-based evidence creation.
NICE often respond to patients and patient groups complaining about using the flawed PACE Trial by
stating that the guidelines did not depend on the PACE Trial.
Yet in the Surveillance proposal consultation document time and time again NICE are using references to this flawed research.
To do so would, of course,
completely invalidate the NICE position and this Surveillance proposal consultation.
Yet this is exactly what must happen.
The PACE Trial cannot be used as it has been thoroughly discredited,
questions have been asked in parliament about possible fraudulent activity in this trial,
and Invest in ME Research have called for a public investigation into the conduct of those involved,
the trial management, the MRC involvement - and also called for the public funding for the trial to be returned.
It cannot be used for reference other than to show the complete failings of CBT and GET.
The PACE Trial is null science, bad science, discredited science, its worth is only to demonstrate how
research should not be conducted.
“To say that the body of intervention studies in ME/CFS has involved disappointingly (and sometimes breathtakingly!) poor science is an understatement. The trend of poorly designed intervention studies, most recently headlined by the PACE trial, has just led to reinforcement of erroneous perceptions about ME/CFS without providing the tools necessary for clinicians like me to help ameliorate the devastating impact of ME/CFS on real peoples’ lives.”
“The subject selection criteria raise the first threat to study validity. Use of the NICE criteria, on its face, seems like a recruitment upgrade from the PACE trial because it mentions post-exertional malaise. However, post-exertional exacerbation of symptoms is not necessarily required for a diagnosis under the NICE criteria; instead, they are considered optional.”
So it begs the question what role is NICE really performing here? It certainly is not benefiting patients.
The "experts" chosen by NICE have probably been all CBT/GET supporters and are still pushing their agenda. The current guidelines and the new comments are geared for idiopathic chronic fatigue and if that is so then ME should have its own separate guideline.
The ME that we know has no connection to childhood problems or maternal
anxiety but an illness that strikes out of the blue in previously healthy persons.
So basically PACE should not be given any value for
Cochrane - or another truly independent body - as it has been shown to be flawed.
Why do NICE accept this?
NICE should ask for the data to to be released for independent analysis
instead to clear things up if there is a controversy.
The way NICE is going about things now is unethical.
We are now left in a strange situation.
The USA priority is to find biomarkers and diagnostic tests whereas UK (with NICE) is trying to
brush this off by placing ME/CFS under an umbrella of FND and treat it with CBT and GET as there is nothing wrong biologically, they say.
In a cynical development NICE (and those who influence NICE) are waiting for selected studies to be completed and PACE data to be incorporated into a Cochrane review in order for them to update the guidelines - yet without mentioning the pending multicentre, placebo-controlled Norwegian Rituximab Phase III trial? Are they not interested in the results of that?
The answer is, of course, no.
It seems to us that NICE is complicit in an attempt to
sneekily introduce an umbrella of Functional Neurological Disorder to include ME - despite the fact that
the Department of Health (which is responsible for NICE) repeatedly respond to charity and patients' letter by stating
numerous times that it considers ME as a neurological condition.
NICE is showing itself to be seriously incompetent – or worse, insidiously compromised by influences from the establishment BPS lobby.
It seems as though NICE is now complicit in the attempt in the UK to steer an increasing acceptance of CFS/ME in to the umbrella of functional (nothing wrong pathophysiologically) neurological disorders (FND).
" Functional neurological symptom disorder (FNsD) is a condition in which patients experience neurological symptoms such as weakness, movement disorders, sensory symptoms and blackouts. The brain of a patient with functional neurological symptom disorder is structurally normal, but functions incorrectly."
This marks a more insidious and worrying development in UK healthcare.
Depending on the final decisions of this consultation review, and maybe not depending on anything – we feel
there may be a case
for NICE to be investigated by parliamentary scrutiny.
The decisions by NICE are so fundamentally wrong, so morally bankrupt and so deleterious to the future
health of people with ME that any decision not to make new guidelines is cause for a campaign to assess the
competence of NICE, its links to known organisations and individuals who influence NICE policies and the
links between the board and any organisations.
This will need public scrutiny and it should be the objective of all patient organisations who really have the welfare of patients at heart to back any future investigation into NICE.
It will almost certainly require a parliamentary committee.
NICE may need to be investigated to determine its true independence.
Possibly Parliamentary questions need to be asked about NICE links to other influential BPS people
Continuing to recommend the flawed CBT and GET for ME is beyond comprehension at this time.
As the NHS is financial trouble then it would be far more beneficial for the patients and the NHS to give honest and up-to-date information about the disease, help with information about education and work and monitor patients regularly to avoid missing other illnesses that may hide in this population.
Psychological supportive services should be provided only to those that really need them.
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).
As with the CMO, the MRC, the DoH and now NICE - we are skirting around the issues and no progress is being made. And these organisations are hiding a hidden policy-based agenda - one not for the benefit of people with ME.
NICE have previously exhibited a poverty of reason with regard to guidelines for ME.
This continues with this mediocre Surveillance proposal consultation – but it also shows a cynical side of NICE which discounts patient experience and participates in a hidden agenda promoting biopsychosocial promotion of ME as a behavioural or FND illness.
It seems clear that NICE has taken the CFS/ME guidelines off the static list to allow a biased Cochrane review to include the PACE Trial data and allow time for the FITNET study to be introduced, but before the results are published from the Norwegian Phase III rituximab trial - in order to push ME under the umbrella of a FND.
If this is true then it is a cynical, negligent - and perhaps criminal - act which will affect all people with ME and their families for another generation.
This must be fought against!
FITNET and PACE will give another 5 years to carry with the mediocrity that we now have in the UK regarding research, services and treatment for ME.
Summary of Recommendations
- Oxford criteria and any research based on them must be dropped from inclusion in any review of ME.
- The PACE Trial has been shown to be totally flawed and any references to it must be removed from the NICE update review.
- CBT/GET must be dropped as recommendations for treatment of ME. Leaving CBT in and removing GET alone is pointless.
- Cochrane must not be used for any review of ME guidelines as it is seen as compromised and biased.
- An update to the guidelines must be made taking into account the above
- A totally new set of guidelines must be created.
- In doing this it would be prudent to separate ME guidelines from idiopathic chronic fatigue.
- Failure to update or revise the NICE guidelines should be a cause for NICE to be investigated by parliamentary scrutiny.
or
Our response is here
