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The PACE TRIAL : Concerns raised by Stonebird



The PACE Trial : these concerns were raised by Stonebird in 2013.
1. It did not study people with ME : the PACE Trial studied: “CFS defined simply as a principal complaint of fatigue that is disabling, having lasted six months, with no alternative medical explanation (Oxford criteria)”.http://www.meactionuk.org.uk/Hoopers-initial-response-to-PD….
2. It wrote its own version of the London Criteria , so that they are virtually identical to the Oxford Criteria.
3. It implied that it was studying people with ME. The PACE Trial Identifier is clear: “Myalgic encephalomyelitis is thought by most to be synonymous with CFS” (PACE Trial Identifier; 2.1).http://www.meactionuk.org.uk/Hoopers-initial-response-to-PD…
4. It recruited a high number of participants who suffered from a psychological disorder. http://esme-eu.com/…/the-pace-trial-do-you-also-get-so-tire…
5. It made sure that the majority of participants have exceptionally high expectations of CBT and GET.
6. It did not admit the most severely affected. http://esme-eu.com/…/the-pace-trial-do-you-also-get-so-tire…
7. It got its results, fast-tracked and published by The Lancet.http://www.meactionuk.org.uk/Comments-on-PDW-letter-re-PACE…
8. It changed the way the trial was conducted . In the original protocol activity graphs were adopted and budgeted, but these were canceled. The patients however were allowed to decide themselves how and when they would report on a scale that was designed by one of the researchers.http://esme-eu.com/…/the-pace-trial-do-you-also-get-so-tire…
9. It ensured that a participant can have a fatigue rating that is both “normal” and “abnormal” depending on which of the Investigators’ various definitions is applied. http://www.meactionuk.org.uk/Comments-on-PDW-letter-re-PACE…
10.It made it possible for a person to record a poorer score on the CFQ (Chalder Fatigue Questionnaire) on completion of the trial than at the outset, yet still be deemed to have attained “normality” on this primary outcome measure. http://www.meactionuk.org.uk/Comments-on-PDW-letter-re-PACE…
11.It made sure there was absolutely no data available regarding what most people would regard as objective markers of recovery; that was simply ignored. http://www.meassociation.org.uk/?p=14333
12. It redefined the meaning of “recovery : the PACE Trial’s infamous “post-hoc” definition of recovery set a threshold for recovered fatigue, using the SF-36 threshold for recovery , lowered from 85 to 60, which is classed as moderately disabled and which would have been regarded as abnormal or excessive fatigue in the original protocol.http://forums.phoenixrising.me/index.php…
13.It did not define or objectively measure "fatigue". Just as the meaning of "ME " was shifted to "CFS", the meaning of "recovery" was shifted to not mean physical recovery, nor to mean loss of symptoms - only the removal of a fatigue that you have not defined in the first place, or measured in any objective way.
14.It made sure that its definition of recovery was not relative to a healthy person’s score by using the English population mean ( which includes elderly and disabled people) - rather than the working age mean .
The PACE Trial confirms how redundant psychiatry has always been in the treatment of ME; the serious neurological disease that is busily destroying lives.

A Continuum of Paralysis

I wake paralysed. I sit, I am paralysed.
I move, then I am paralysed. Noise hits me and I am paralysed. I eat and I am paralysed. I lie down, I am paralysed. I am too still, I am paralysed. I am too hot, I am paralysed. I am too cold, I am paralysed.

My stomach is paralysed. My eyes are paralysed, my legs are paralysed. My feet and toes are paralysed.

My mouth, my lips, my jaw, my throat are paralysed. My face, my eyes, my eyelids are paralysed.

My arms, my hands, my fingers are paralysed. My chest muscles are paralysed.

My left side is paralysed. I am totally paralysed. My day is paralysed. I am in a continuum of paralysis.

Being Present through Transforming Suffering

There is nothing romantic, you find, about witnessing your loved one’s suffering. It is coarse, raw, sweaty, smashes into shards your fragile ego, strips naked that which you would never expose, leaves you almost unable, after decades, to bear another moment of it.

 I am learning about limits. My website, Stonebird, is rarely updated now. I have journeyed way beyond whatever ability I had to campaign. I survive here, far out of reach, on a vicious distant edge, that few , if any, care to know about.

 How ?

Suffering reeks of despair. You must never let it take you over. I am re-reading Victor Frankl’s masterpiece on how to rise above suffering, “Man’s Search for Meaning”. He writes, out of Auschwitz, that a man has an opportunity “to make use of or forgo the opportunities of attaining the moral values that a difficult situation may afford him.”

 You can face your situation with dignity, you can find meaning and purpose, you too can attain spiritual freedom and insight, that is Frankl’s burning message and challenge.

 Or you can give up and die.

 The choice, every moment, here, as I have said many times, is a stark one. To take either the path of life or death.

 Death, I tell you, feels like emotional numbness, screamingly awful. Life, meanwhile, is creative, light, joyful. One way generates tears, division and anger, the other contact, sensitivity, a smile.

 Service or withdrawal.

 Presence or irritation.

 Interaction or game-playing.

 You cannot give-in. It takes enormous discipline, I find, to resist the temptation to sink into victimhood, completely overwhelmed by your situation. That way lies self-destruction.

 It takes rugged determination to put on your cycling gear, or your coat and shoes, or pick up your shovel , if you can and get yourself outside, feel the earth, the sky, the wind biting your face, but you must do it ! What is the alternative, apart from self-obsession, trying to hide from your feelings and more dangerously yourself , in an empty, terribly lonely, sad indulgence, going nowhere, except to the bottom ?

 It takes great self discipline to transform suffering, to discover, in the process how liberated you become, how alive, how creative.

 I find that I am bubbling with ideas, stories, songs. I sit down at my keyboard with utter joy. I have invested in all kinds of creative software, recording, music-creation, animation writing, web design applications that provide a rich outlet for my crazy ideas, schemes and dreams.

 Riddled with self-doubt, still I publish my books, put out my music, build the websites. Each time it is a victory in boldness, a lesson in being real, and fun unbounded !

 Recently I published a  boogie-woogie “ Santa’s Twisting” animation. The deafening horns, driving sax,  thundering drums  merry, animation and rockabilly piano stand in vivid contrast to the still, silent, suffering reality that they were composed and performed in, whispered behind closed doors, on the computer.

 But with the blessing of song and the power of animation I can have a ball in a swinging Christmas pub, or be a lean cowboy in Arizona or a goldfish, which I found particularly poignant : all these things I have done on my new website : http://www.lonelyanimator.co.uk/

 Paradoxically, the creative process frees me to be more truly myself, more able to be real and present in the world, in order to hold , comfort, think of ways forward, in impossible situations.

 There is nothing romantic, as I said, about suffering. Love, on the other hand, is eternal, the romance, I am here to tell you, never dies ! The tiniest gesture, when performed in love, is pregnant with hope  and possibility.

 That you come to learn, with a tear in your eye.


Greg is the author of : “Severe ME, Notes for Carers
http://stonebird.co.uk/Notes/index.html

& “Severe ME, Featuring Justice for Karina Hansen
http://www.stonebird.co.uk/severemebook/severeme.html


 Greg Crowhurst 12th December 2015 


Paralysed in poetry and images





Paralysis seems to capture my thoughts
And lasso them into an invisible plastic bubble
That floats formless in my mind.
I know inside what I want to say.
I can see you before me vaguely through dark staring eyes
Or sense your presence when lids are locked tight
Yet the words will not marshal themselves together
And I cannot make them comply with my will
So that they can come marching down to my mouth
They will not spill out into the world
To make coherent sense.
The lips lie fallow, unused.
They are numb.
They will not move.
The breath is shallow
Not enough breath then to give sound to the voice?
But no
It is more than this.
The thoughts, though perfect, whole and complete
Are stuck, as if in
Suspended animation.
There is no path for them to the outside world.
It has mysteriously vanished.
And you cannot know then
How sad I am
How distressed I am
To be like this
Yet again
How much I need your contact
But cannot bear your physical presence
How amazingly interesting I am inside
Trapped
In this invisible
Tortured
Empty space
And how lonely
It is here
Stuck in a world that is completely inaccessible
No matter how near
Or easy it is for you
To access.