Alem Matthees analyses on released PACE data blast "recovery" claims - huge damage to PACE

[Wolfiness]

PACE authors will still try to spin these pathetic results as success, failing to acknowledge the problems of lack of blinding and the Oxford criteria.

I'm a little stunned actually at how tiny the 'therapeutic' effect was, given both the placebo/brainwashing element and the Oxford criteria element. Where do these results leave our "they probably didn't have ME" criticism?

Also, I'm curious what the implications are as the the psychiatric treatment of fatigue in general. It seems clear that a significant proportion of patients included in PACE had unexplained chronic fatigue type disorders, but we can no longer put any success rates down to their own response, because there is no success rate. Does this mean that Chronic Fatigue as a disorder is simply untreatable? Or dies it perhaps mean that the behaviourist method of treating people like machines without having recourse to their personal circumstances is dying on its arse.

Maybe we should be treating chronic fatigue as another kind of physical fatigue puzzle, rather than taking the Hummingbird route of looking down our noses at them and telling them that if they don't have PEM they don't properly exist as a clinical entity.

 

[Wolfiness]

On the positive side, Julie's story about "millions being misled by bad science" is quite a good counter-narrative. If only we can make that stick.

"Downtrodden patients start a revolution from their beds" is a fantastic counter-narrative. I would write it myself if I knew all the facts and wasn't sinking into mental slurry.

 

[Sidereal]

https://twitter.com/i/web/status/779037635956400128

 

[A.B.]

I'm a little stunned actually at how tiny the 'therapeutic' effect was, given both the placebo/brainwashing element and the Oxford criteria element. Where do these results leave our "they probably didn't have ME" criticism?

It didn't consider the use of Oxford criteria to be important, even though it's a valid criticism since it's a flawed definition. I think it is important to point out that even these poor results from PACE are exaggerated. Yes, it really is that bad.

 

[Wolfiness]

I suppose 20% of a non-specifically fatigued population showing subjective improvement is believable but I would have expected it to be much higher. Honestly I would have expected about 20% improvement with no treatment at all. So for me as someone who's always been willing to listen to psychoneuroimmunological arguments, PACE has shown that this illness is even more biologically uncompromising than I thought. This study may end up becoming a *gift* to us. I can't see how it could serve BPS worse.

 

[Tom Kindlon]

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References:
https://www.facebook.com/tom.kindlo...1141611095933415&comment_tracking={"tn":"R0"}

(i) Stat News: https://www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/
(ii) BMJ: http://www.bmj.com/content/354/bmj.i5053
(iii) Improvement (protocol definition): http://www.wolfson.qmul.ac.uk/image...otocol_based_analysis_final_8th_Sept_2016.pdf
(iv) Improvement (new, non-protocol definition): http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/fulltext
(v) Recovery (protocol definition): http://www.virology.ws/2016/09/21/no-recovery-in-pace-trial-new-analysis-finds/
(vi) Recovery (new, non-protocol definition): https://www.cambridge.org/core/jour...e-pace-trial/6E3A5B37D427239D146C5EB276A11E06

 

[Amused]

https://twitter.com/i/web/status/779304423990239232

Oh this may explain why Mr Tuller seemed so very cross in his latest Virology post. He was far more stern than I expected. Especially because best practice for clinical trials is pretty central to his day job (academically speaking) and he knows what he's talking about. So when Wessley etc dismiss what everyone else is saying about their emporer's new clothes, it's doubly galling for Tuller and others like him cos he knows damn well they are mistaken.

Personally I don't quite understand how actual facts based on actual data can be so blithely disregarded by Wessley etc. It's as though they don't have anyone around them saying 'actually, um, these are facts and data, now you are looking like a right numpty'. I know people have vested interests and hobby horses, but I did sort of expect them to be well, less blind, than they are...

 

[Amused]

On the placebo effect, isn't that one of the things David Tuller raised in his virology essay - it can't be placebo cos you can tell the difference between what you're being told and actual reality? so it doesn't really work?

Certainly they said 'we don't have a magic bullet but we think we can get you doing more' at the beginning.
However every session thereafter involved them telling me to reduce activities and giving stuff up. To which I was hugely resistent but did eventually do. I do remember at the first proper CBT session giving an enormous list of things I wasn't going to give up and he'd have to fix me with that. Snort! I ended up doing NOTHING on that list that wasn't surviving or work by the end.

So faced with that reality, how I felt was annoyed, puzzled and frustrated. (as was the therapist, apparently it should have worked but didn't lol). In physical terms my functioning reduced, my symptoms were a bit less horrible, but my mood was pretty low. I can't quite see how any placebo can exist if the patient knows it's not working, cos it's obvious from the sessions, otherwise we'd have been talking about maintaining a baseline or increasing it, which in reality were sections of the Manual we never even opened....

I may have been feeling charitable and grateful enough to give a higher score on the questionnaires due to me feeling they were trying to help me, except I'm pretty sure I filled them in based on my personal reality rather than their wishful thinking!

 

[Amused]

One thing I had sort of forgotten in the intervening years until this all came up again (for me) after Mr Tuller's work was how annoyed I was that I wasn't better. I'd put all that effort in and it hadn't work. I felt I'd been sold a pup.

I do still feel that when delivering CBt or whatever else, people should be told it's a coping mechanism not a fix. I can sort of understand that people were told it was a fix for the purposes of the Trial - given it was supposed to be about how people perceive and think about the illness and their capabilities. But I still don't understand why with such parlous results (even before the reanalysis by Alem Matthees et al) they carried on presenting it as a fix.

Someone above says that it's now dead in the water - when the PACE papers came out and hte results were pretty pathetic, I thought that was that, it's a dead end, it'll go down biomedical routes now (which it has, though mostly throuh the sheer efforts of patients etc). So in a way the fact it's now even more of a dead end is a good thing. Excpet as someone else said, there's Magenta going on on kids rightnow.

 

[Wolfiness]

I had OT privately with someone who had been a therapist on PACE and like @Amused , it just got nowhere because I kept doing too much - I got manic and couldn't keep to the baseline, even though I do keep to a baseline on my own 90%> of the time. The fact that they came across as well-meaning but plodding with no insight into the condition probably didn't help. But people being manic and unable to control the urge to do stuff whatever the consequences is yet another reality of ME that BPS believe you can just choose to overcome.

 

[Cheshire]

https://www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/comment-page-6/#comments

Someone (Richard) highlighted a part of SW's comment that is very telling:

And indeed I happen to think the changes were right – the criteria they settled on gave results much more congruent with previous studies and indeed routine outcome measure studies of which there are many.

Simon, are you trying to justify protocol changes simply because they made the results look as the authors wanted them to, ie in line with previous much smaller studies? That’s an absolutely astonishing admission.

Edit: I must add that Richard's whole comment is very good and worth a read: https://www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/comment-page-7/#comments
Eg: the above, I’m afraid, is a very intelligent, erudite man making ridiculously indefensible points in the hope that his reputation and position will encourage medics and academics alike to dismiss the criticisms without ever scrutinising the trial themselves.

 

[Gijs]

I would like to know much more in detail about the protocol, who was the commission? Were they independent? what time the changes were made? etc...

 

[BurnA]

Someone (Richard) highlighted a part of SW's comment that is very telling:





Edit: I must add that Richard's whole comment is very good and worth a read: https://www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/comment-page-7/#comments
Eg: the above, I’m afraid, is a very intelligent, erudite man making ridiculously indefensible points in the hope that his reputation and position will encourage medics and academics alike to dismiss the criticisms without ever scrutinising the trial themselves.

Wow Simon Wessley basically just admitted it's ok to change the protocol if you get the results you want.

That should be the end of his career there and then.

Absurd that he admitted it, but that's what stress and panic must do to people.

 

[Mrs Sowester]

Wow Simon Wessley basically just admitted it's ok to change the protocol if you get the results you want.

I know, my jaw is on the floor. This must be the All New and Improved Wessley Scientific Goalpost Shifting Principle (TM) where if your findings don't replicate previous studies you can just shift those pesky goalposts till you get the results you need.

 

[Sean]

Wessely and that whole cult are starting to realise that the world is not reflexively bowing down to their fairy tales any more, and that this has serious and unavoidable consequences.

 

[flybro]

Concerns about PACE from AcedemicAnge,

and Margeret Williams
Articles on ME/CFS by Margaret Williams and Prof Malcolm Hooper and others

Lucky to have the knowledge base thanks to our long standing advocates.

 

[Woolie]

The PACE authors have experienced a major clash of research cultures. As psychosocial researchers, they come from a research culture in which methodological standards are low, and where researchers tend not to criticise each other at all, or if they do, only on ideological points. Many have medical practice backgrounds - like White and Sharpe- rather than science ones, and this may be why methodology is not emphasised.

Publishing PACE took these researchers out of that comfortable community and exposed them to the methodological standards of clinical trials. On the whole, they did raise their game quite a lot (take a look at some of the pre-PACE work these folks did, and you'll see what I mean). So they naturally feel that their standards were really high, and that everyone is making a fuss out of nothing.

Oh, and of course, they come from an area where authority counts for a lot - if you have the right title, you're respected. In the wider world of science, that counts for less. Must have been a shock to them.

 

[Woolie]

PS in one way I do feel sorry for them: they are not the only weak researchers in the world, and not by any means the worst ones. Its just that the other ones are working on subjects that don't have the power to do harm the way PACE does. So they get left alone, and its PACE that gets picked on.

Of course to us, that's totally reasonable. Their bad work is harming people, so let's concentrate on that first, worry about all the other harmless bad research out there later.

 

[Kati]

https://twitter.com/i/web/status/779844188208631808

 

[Seven7]

Has the one month vs the 6 month of fatigue requirement being verified (so it was not even oxford criteria)