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How CG53 failed patients

Stonebird


Greg Crowhurst November 2016

NICE are currently considering whether their guideline CG53 Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management requires updating.

IT MOST CERTAINLY DOES !!!

When CG 53, based upon a handful of low quality Randomised Controlled Trials  that were methodologically flawed,  was published in 2007 almost all the UK ME Charities condemned it as unfit for purpose. This is hardly surprising given that the Guideline Development Group (GDG) excluded from its membership all NHS specialists experienced in treating adult ME patients .

As Kevin Short (2012) comments: “This is shocking by any standards: imagine the media outrage if a NICE guideline on infectious disease excluded all virologists from its production or a guideline on breast-cancer excluded all oncologists?

The ME community greeted NICE’s guideline with disgust and widespread outrage that so much evidence about ME had been ignored.

Over twenty renowned ME experts later provided Statements to the Court (Judicial Review of the NICE Guidelines) challenging the validity of the research that NICE used for its Clinical Guidelines.

Here is a brief overview of the many ways NICE got it so wrong :

CG 53 :

  • Failed to grasp the full nature of neurological ME and the implications for management, and also failed to provide adequate guidance for diagnosis.

  • Failed to include experts from all the relevant professional groups on the Guideline Development Group ( GDG)

  • Failed to give patients' / carers' views equal weighting and status, as subsequently confirmed by two members of the GDG.

  • Recommended widespread use of the psychosocial rehabilitative treatments of CBT(Cognitive Behavioural Therapy) and GET (Graded Exercise Therapy) in spite of reports of harm from ME. At best this means that the main thrust of the guidelines are irrelevant for most people with ME, at worst dangerous.

  • Failed to consider the relevant evidence about the illness. Did not study the aetiology and pathogenesis of ME, this meant that thousands of papers could not be discussed as part of the process. NICE ignored the international evidence that ME/CFS is a biomedical, not psychiatric, disorder, claiming that studying this evidence fell outside its remit.

  • Placed undue emphasis on two treatments - cognitive behavioural therapy (CBT) and graded exercise therapy (GET) - for which the underlying evidence is inadequate and unrepresentative.

  • Did not agree to recognise the World Health Organisation's classification of M.E. as a neurological illness.

  • Did not convey or reflect the impact which the illness can have on the lives of those people who are most severely affected by M.E

  • Relied upon an "evidence-base"which has been exposed as deeply flawed by virtue of the heterogeneous populations studied; the methodological inadequacy; the corrupted data; the high drop-out rates; the undeniable ineffectiveness of CBT/GET as shown by the outcomes measures, and the finding that the claimed benefits may have been illusory. (see: "Inadequacy of the York (2005) Systematic Review of the CFS/ME Medical Evidence Base" by Malcolm Hooper & Horace Reid at http://www.meactionuk.org.uk/FINAL_on_NICE_for_Gibson.html)

  • Created a wholly inaccurate picture of ME : a serious disabling neurological and multi-system dysfunction disease; the Guideline more accurately describes patients suffering from idiopathic fatigue, as outlined by the WHO at ICD-10-f48.

  • Limited their consideration of the literature to that which supports the psychiatric paradigm of ME and failed to take account of the available published biomedical evidence about ME, without knowledge of which the Guideline fails to provide an aid to diagnosis (as was its remit).

  • Based its management recommendations on weak and inconclusive studies of dubious quality on heterogeneous groups of people, the majority of whom were unlikely to have ME but may have suffered from any one of over 30 other disorders where "fatigue" is a symptom.

  • Its conclusions did not coincide with the majority professional view of the international medical and scientific communities about ME.

  • Confused ME with other conditions and fatigue states and have poorly married together two opposing views : the psychiatric model which says "unhelpful illness beliefs", "thoughts, feelings, behaviours" and "over-vigilance to symptoms" perpetuate the illness and the biomedical model, which validates the physical illness. This has led to a flawed document that meets no-one's real need, with a predominance of psychiatric interpretation.

  • Disregarded the fact that patients are almost universally opposed to CBT and to GET, because survey after survey has shown that GET can be harmful to people with ME.
  • Disregarded the fact that patients are almost universally opposed to CBT and to GET, because survey after survey has shown that GET can be harmful to people with ME. NICE has produced Guidelines for many different clinical conditions. Only in the case of the organic disorder ME is CBT recommended as the primary treatment of choice.

  • As Margaret Williams (2007) has extensively documented, NICE appears to be in breach of the AGREE guidelines, a rigorous methodological process it is expected to follow in drafting clinical guidelines.

  • Significantly NICE proscribed the use of supplements and vitamins in the treatment of ME. Specifically it states : There is insufficient evidence for the use of supplements – such as vitamin B12, vitamin C, co-enzyme Q10, magnesium, NADH (nicotinamide adenine dinucleotide) or multivitamins and minerals – for people with CFS/ME, and therefore they should not be prescribed for treating the symptoms of the condition. (NICE Clinical guidance 53 )

Margaret Williams (2008) comments : “the proscribing by NICE of appropriate testing and its stipulation that any vitamin or mineral deficiency must not be corrected by prescription would seem to constitute a real and even life-threatening danger to people with ME/CFS.

NICE’s proscription, although only guidance, is quite extraordinary , in light of the evidence.


Conclusion

The ME community has for many years suffered from the psychiatric takeover and denial of their illness, leaving doctors and patients floundering in a sea of misrepresentation,misinterpretation, mistreatment and misdiagnosis.

CG 53, as this document has outlined,  is a prime example of how the physical tortuous reality of neurological ME is constantly denied, diminished, negated and ultimately neglected. The ME Community , we pray, will grasp this opportunity, especially building upon the recent exposure of the PACE Trial, to show how unfit for purpose the NICE Guideline is.



References :

Short K(2012) A CALL FOR A PARLIAMENTARY SELECT COMMITTEE OF INQUIRY INTO UK ME & CFS POLICY http://www.angliameaction.org.uk/docs/wessely-misleading.pdf

Williams M (2007) Comments on the NICE Guideline on “CFS/ME”:


Williams M (2008) More potential dangers of the UK NICE Guideline on "CFS/ME" for people with ME/CFS Margaret Williams http://www.meactionuk.org.uk/Dangers_of_NICE_for_MECFS.htm




Severe ME : Patient Surveys

It is striking how much the experience of the severely affected is comprehensively ignored.

As an example, in conjunction with the 25% Group we poured heart and soul into doing these two rare regional and national surveys of people with Severe ME, to try to affect change locally for a biomedical service in Norfolk and nationally for the Gibson Inquiry, yet they are never quoted.

This publication is an attempt to rectify the situation.

 The voices in this document, still unheard , are of immense importance; their experience of ME is infinitely more extreme than the mainstream, many of whom may not have Myalgic Encephalomyelitis in the first place.

These surveys reflect an almost total lack of understanding of this marginalised group.

It is to the NHS’s shame that people with Severe ME still receive little to no service or support.



The disease that used to be known as “ME”

The disease that used to be known as “ME” is not recognisable under the umbrella terms of ME/CFS or CFS or CFS/ME.

"ME" has become a meaningless term; a complete and total disaster for everyone
We are sick of the misrepresentation, the misinterpretation, the lack of clinical respect, the focus on fatigue, the compromises, the misdirection, the mistreatment and misinformation that constantly negates the disease and holds out little hope of change, especially for the most severely affected.

Clinicians and charities have, we suggest, contributed to the demise of the term ME by focusing upon fatigue and not the more serious Neurological/Cognitive, Autonomic, Neuroendocrine, Immune, Cardiovascular and Gastric manifestations and Enterovirus as the cause of the disease .

They have failed to stand up adequately, if at all, against the damning involvement of psychiatry, often colluding with them openly, condoning for example a research collaborative here in the UK that openly includes and is led by psychiatrists, rather than pushing boundaries enough to get real change.

They have allowed the mishmash CFS continuum to continue by uncritical use of the term and by accepting poor and varied use of different criteria that result in poor, inadequate diagnosis and recognition.

In our long experience, they have displayed professional arrogance and mistreatment in spades through their ignorance of the most severe symptoms, especially paralysis.

They have shown little understanding of the extraordinary degree of awareness and skill required in interacting with someone so ill and so hypersensitive.

The consequence is that people may or may not have the neurological disease, “ME” identified by Ramsay et all. How can anyone know, if there is no test that identifies it and the only one that was created for it has been disregarded and no longer offered?

Even if you can find a knowledgeable and experienced doctor, without a diagnostic test, there is no real certainty that you have what they say.

At the end of the day, when you really look at it, it is all, shockingly, guesswork. We are all being left in the dark with no proper service. Any treatment options surely are trial and error posing a grave risk particularly to the most severely affected.

In truth we are all living in a nightmare.

What we need to do is demand the physiological explanations that underpin our symptoms and illness experience. Without this knowledge we are all endangered.

A test should be the first priority, we should at least fight for at least the VP1 test to be reinstated in the UK . Everything else means endangerment for some at least and continued misuse of the name Myalgic Encephalomyelitis.

Stonebird
Greg Crowhurst
November 2016

23 years

Today is our wedding anniversary. 23 years of love and 23 years of indescribable physical pain and repeated paralysis and torment, 23 years of speaking up and fighting for appropriate help. 

How do we celebrate? We light a candle and give thanks for our love which has grown despite the horrendous circumstances and medical negation experienced down the decades. 

We hold on to hope that next year will be better, that the truth will be revealed, that understanding will manifest and justice be found.

An anniversary then both of loss and hope. We pray for strength to carry on. We ask for healing. We want answers. May this be the year.

The Box of Chocolates

11pm, my wife is slumped in unabbreviated agony, but there is extra pain tonight, her right wrist is burning up, a fly is tormenting her and everything I do is a profound irritation. The slightest mistake, like scratching my head, plunges her ever deeper into the terrible chasm, that is pulling her, inexorably, ever deeper into the molten centre of the earth.
Far below normal life and routine, we are buried deep, both of us. It is beyond reason or comprehension that it has been like this for well over two decades.
Looking back I think can distinguish three phases to our journey into suffering.
1. The age of hope and rainbows
You look for the meaning within, you seek to transcend the situation, through prayer, meditation, candles, mantras hoping, at least I did, that by seeking and finding a higher path that you will learn what you need to know about making choices, letting go, forgiveness, healing, and putting healthy boundaries in place.
Then there will be freedom, if you affirm it enough, to choose to move on free from fear, restored, renewed, whole again.
Those dreamy New Age books clutter my shelves. Much loved, no longer read, invaluable.
If you were to draw a population graph, I sense that most professionals, family and friends and those who try to help, have not left the magical age of hope and rainbows very far behind.
2. The age of activism
You get up and do something about the dire situation you are in. Those of us on the edge, trying to deal with the prejudice that surrounds having a poorly understood, medically neglected, incomprehensible disease, eventually learn that we have to speak up or nothing is going to change.
So I did. For many years I was extremely active and some kind of voice. But things move on and so do you. It becomes more and more impossible to even post on Facebook anymore, such is the immense stress you are both under. Your voice grows silent, even forgotten; that is what it is starting to feel like these days.
3. The age of silence
My wife describes this place :
"Time passes strangely here. It is slow, silent, flat, even empty often and yet at the same time, seemingly endless, but of course, this is an illusion. Pain makes the moment you are caught in, a terrible terrible place of unending agony. You know not how long it will torture you, nor how long you can bear it and yet bear it you must, on and on and on...You learn to live in its burning, throbbing, screaming grasp. You long for it to ease, to lessen, to cease to dominate your whole being. You beg for it to be taken from you. You pray it will not hurt you beyond your capability. "
My greatest achievement? I can sit on a bench for hours, silently and find contentment there. This is where my journey has brought me. To love. All that remains is love and the great silence. Our love is so immense, so huge, so powerful, it carries us through situations so bad, I am not sure you would know what I am talking about. Love has never failed us, love grows and keeps on growing, a wonder, a delight and a saviour.
Love is free, it reaches out. There are miracles aplenty.
Yesterday was very bad indeed, for my wife was struggling to cope for another second.
I was holding her, trying to cope myself, when the post plonked through the letter box.
A single parcel marked “Fragile”.
A beautifully wrapped and presented, dairy free, box of Bianca Marton Artisan Chocolates; oh like nothing you have tasted in your life, they are so delicious.
Out of the blue, an eye-wateringly expensive gift from someone obviously special, seeing the love between us, saying:
'Thanks for loving each other in dire circumstances and for working so hard to make the world a better place. With love from Sue K'
These chocolates are an unconditional gift that blesses us in the deepest way.
Can you begin to imagine what that means to us, here in the silence?
No words are possible to describe it.

Greg Crowhurst
(Published in the Autumn Edition of MCS Magazine )

They use our name but they do not treat our disease.

The use of the nonsense term "ME/CFS", tragically is epidemic.

 What exactly does it mean ? To us "ME/CFS"  means "ME/not-ME"...... 

If you use the term ME/CFS  you are all over the place, because you couldn't  possibly have a clue who or what you mean.


This is because “ME/CFS” is an umbrella term, subject to many different interpretations, incorporating a wide range of meaning and poorly identified conditions. 

Myalgic Encephalomyeltis,on the other hand,  is
a complex multisystemic metabolic-inflammatory disorder, involving profound dysregulation of the central nervous system , immune system dysfunction, cardiovascular abnormalities, autonomic nervous system dysfunction, formally classified as a neurological disorder,  in the International Classification of Diseases (ICD10:G 93.3; WHO 1992).

 Very few patients in the UK, however, receive any physical investigation or treatment, especially the most severely affected. This is because of decades of denial, cover-up and deliberate neglect.


 

End Carer Poverty !!!

Unpaid  carers, like myself, save the UK  £132 billion a year.

Yet  those of us who care 24/7 are paid just 0.37p an hour !

Hidden away, isolated,  abused by the community,    trying to cope under the most  intense  emotional and physical pressure : millions of us are outrageously forced to live  in POVERTY.

CAN YOU POSSIBLY  IMAGINE WHAT THAT  IS LIKE ?

In addition, if my wife died tomorrow I would be thrown , exausted after almost 25 years of care, literally onto the scrapheap.

Why  is our contribution to society so devalued ?

Why does the UK Government so disrespect us ?

Why are carers, like myself,  at least not paid the minimum wage ?

References :

Aldridge H, Huges C (2016) Informal Carers, Poverty and Work
 http://npi.org.uk/files/8314/6410/7016/Informal_Carers_Poverty_and_Work_-_Summary.pdf

 Carers UK (2016) Evidence for the Carers Strategy


http://www.carersuk.org/for-professionals/policy/policy-library/submission-to-the-carers-strategy