PACE trial TSC and TMG minutes released

Jonathan Edwards said:
There are sentences on the net looking very like the one @Daisymay quoted where the name is Wessely. He was certainly director of the CTU responsible for PACE as far as I can see, at least at some point. What is not clear to me is whether this is the entire MRC CTU or whether it is a subsection.
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Lucy is right. The chair was (now Dame) Janet Darbyshire.
 
Jonathan Edwards said:
That is the more charitable reading. I don't actually think it has to do with institutional prestige and affiliations. How did Andrew Wakefield get to be published? The Royal Free surgery department was hardly high profile.
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I can answer that, cos I was there at the time! AW was published because RH thought he was doing the "right thing" by making sure that the paper didn't go elsewhere saying the "wrong thing". He made AW et al change the paper so that it stated that there was *no* association between MMR and "the syndrome described" - in accordance with the findings. He didn't bank on AW then holding a press conference and saying the opposite. Unfortunately, the media (and probably most subscribers to The Lancet) don't actually read the papers.
 
Lucibee said:
I can answer that, cos I was there at the time! AW was published because RH thought he was doing the "right thing" by making sure that the paper didn't go elsewhere saying the "wrong thing". He made AW et al change the paper so that it stated that there was *no* association between MMR and "the syndrome described" - in accordance with the findings. He didn't bank on AW then holding a press conference and saying the opposite. Unfortunately, the media (and probably most subscribers to The Lancet) don't actually read the papers.
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I don't doubt all that happened. But you don't publish a bad study just to avoid it going elsewhere. Surely Horton should not have even considered it? My wife provided data used in that study and at the time it seemed that certain people were providing support.

I do not have your inside view but have been involved in decisions from an outside position and my impression is that personalities in political roles may have been more important than just institutional reputation. In many cases it may amount to the same thing, but in this case the question is whether people in politically pivotal positions with no actual scientific track record were instrumental.
 
Some things you find on the internet are wrong. I suspect there has been much conspiracy theorising and spinning done in the absense of evidence over the years. SW's lack of involvement in the trial was probably strategic - and to be fair, does maintain some independence. The Chair of the TSG has always been Janet Darbyshire, who was Director of the MRC CTU at the time.
 
Jonathan Edwards said:
So are the sentences on the internet wrong? I think they come via IiME or possibly Margaret Williams. And what about the picture of Wessely as head of CTU posted above?
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I believe it is as Lucy says: Those shots are about the Kings CTU which played a prominent role in the trial. The reference in the minutes ('REDACTED, who is the director of the Clinical Trials Unit at the MRC, has agreed to chair the TSC') is to the MRC CTU and the name redacted is Darbyshire's.
 
Lucibee said:
SW's lack of involvement in the trial was probably strategic - and to be fair, does maintain some independence.
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I can see it may have been strategic but then it certainly doesn't maintain independence in any fair sense - just a canny impression of it! If SW was independent he would not have made the disingenuous remarks he made to me in personal emails which I will not repeat because he asked not to get involved in the internet - even if he is very happy to do so when he so wishes!
 
I am still a bit confused about the idea of Wessely being uninvolved in view of @Sly Saint's image. It seems that there is a CTU that has a newsletter and this CTU is run by Wessely and this CTU was involved in the running of the trial.

Edit: I see we are in agreement on this.

I understand the scenario that Wessely had done previous studies and might want it to appear that PACE was independent confirmation by others. I have been in exactly that situation myself. However, to be head of the CTU running the protocol and NOT be an author seems pretty devious. I did the opposite. I was an author but had nothing to do with running the study. The people running my study actually expected to prove me wrong - which was a healthy situation.
 
Jonathan Edwards said:
I am still a bit confused about the idea of Wessely being uninvolved in view of @Sly Saint's image. It seems that there is a CTU that has a newsletter and this CTU is run by Wessely and this CTU was involved in the running of the trial.

Edit: I see we are in agreement on this.

I understand the scenario that Wessely had done previous studies and might want it to appear that PACE was independent confirmation by others. I have been in exactly that situation myself. However, to be head of the CTU running the protocol and NOT be an author seems pretty devious. I did the opposite. I was an author but had nothing to do with running the study. The people running my study actually expected to prove me wrong - which was a healthy situation.
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The paper does name Wessely as a centre leader:

'The centre leaders were BA, TC, Eleanor Feldman, GM, MM, HO, Tim Peto, MS, PDW, DW, and Simon Wessely. The centres were at St Bartholomew’s Hospital, London; Western General Hospital, Edinburgh; King’s College Hospital, London; John Radcliff e Hospital, Oxford; Royal Free Hospital, London and the Frenchay Hospital, Bristol (all UK).'
 
Jonathan Edwards said:
Horton described the PACE paper as 'eagerly awaited'.
Was he short of good copy?
Considering that the great majority of physicians have still to this day never heard of the PACE trial - all about some physio or counselling for chronic fatigue or something? - why on earth would he think it newsworthy?
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Jonathan Edwards said:
In the radio recording that someone uploaded here a while back Horton says the trial was eagerly awaited. It was clear from his tone that he knew well in advance that he was expecting a slam dunk trial.

I think this has to confirm the suspicion one has always had that the editorial policy at the Lancet was little more than mingling with the in-crowd and picking up what was a hot favourite.
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I think you've more or less just answered your own question. In the radio interview Horton says,
ABC Nat. Radio April 2011 said:
Richard Horton: We were delighted to get this trial, it was eagerly awaited. It was a remarkable study because the investigators stepped back and were willing to do an experiment comparing conventional treatments for chronic fatigue, cognitive behavioural therapy for example against a treatment which was very much endorsed by parts of the patient community but very sceptically received by the more scientific community and that was the adaptive pacing therapy. So they were really stepping back and comparing two philosophies, not just two treatments, two philosophies of what chronic fatigue syndrome was.

Norman Swan: In other words whether or not you can be rehabilitated to some extent and whether or not you should actually just adapt to the condition.

Richard Horton: Yeah, I mean adaptive pacing therapy essentially believes that chronic fatigue is an organic disease which is not reversible by changes in behaviour. Whereas cognitive behaviour therapy obviously believes that chronic fatigue is entirely reversible and these two philosophies are kind of facing off against one another in the patient community and what these scientists were trying to do is to say well, let’s see, which one is right.
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http://www.meassociation.org.uk/201...n-abc-national-radio-australia-18-april-2011/

That reads to me that Horton saw the trial as a significant contest between the worldviews of the patients and of the BPS model, and he wanted the scoop proving BPS correct.

However, not just to prove something in ME/CFS, but because there was a bigger picture for the BPS model.

The BPS model was implemented in UK welfare policy with the aim of reducing the number of people receiving government support, but the science, or lack thereof, behind it was disputed from early on.

In 2002 all three of the PACE trial's principal investigators, along with Aylward, Waddell and Wessely, contributed to a conference and book which promoted the use of the biopsychosocial model.[127] The book was made up of conference papers and transcripts of discussions, and includes Waddell explaining how the biopsychosocial model was gaining political influence:"It is all about money. The main thing was to persuade the treasury that there was an opportunity for keeping costs down, particularly over the longer term."

In response to another participant saying "if you go to Gordon Brown (UK Chancellor) and say, 'We can prove to you that if we address this issue, we can save £2 billion', then you will have his full attention", Mansel Aylward replied: "That is the approach that has been taken, but not in such a robust fashion."[127]

Their discussions explained how, within government, the antipathy caused by the view that the biopsychosocial model lacked a hard evidence base had been overcome by the softer evidence of "authoritative and expert opinion".
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The evidence used to support the biopsychosocial model is often weak, or misleadingly presented; however in 2006 the DWP funded a group of academics to begin the PACE trial which the Wolfson Institute of Preventative Medicine describes as:

"This large-scale trial is the first in the world to test and compare the effectiveness of four of the main treatments currently available for people suffering from chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME)."

Results from this trial were first published in 2011 and were presented as an exciting success for biopsychosocial interventions. Since then the Government has gone on to use the biopsychosocial model, and the theories underpinning it, to suport its general approach to benefits and welfare reform. For instance, in 2012 Lord Freud defend the 'reform' of Disability Living Allowance in the House of Lords by saying:

"...we have gone for the biopsychosocial model. That model has now garnered very significant academic support, as those noble Lords to whom I sent that very interesting piece of research will recognise."
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http://www.centreforwelfarereform.org/library/by-az/in-the-expectation-of-recovery.html

So given all that, I suspect Horton saw publishing PACE as a great scoop both scientifically [sic] and politically: it's not just a trial about CFS, but a key piece of evidence [sic] supporting the use of the BPS model for welfare reform.

ETA: Hence also why it's so difficult for Sharpe, Wessely, Horton et al to admit they got it wrong: a whole government policy has been built on the model they promoted.
 
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Jonathan Edwards said:
No, I agree with Trish that it is very odd for there to be an Analysis Strategy Group in existence after the trial has formally commenced. By 2000 it was very clear to people running trials that your analysis needed to be decided before you started. It rather looks as if the MRC fell well below basic standards on this in its 'CTU'.

More and more the message from this trial is not so much that the authors were incompetent but that the MRC was incompetent in its role as a guiding influence.
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I'm still reading the TSG minutes but its not just the analysis plan they hadn't done for the start of the trial. The database wasn't ready and part way through the first year they were just moving to version 6.

What has really struck me about the minutes is they clearly lack any form of project management. There seems to be no idea of planning or experience of running stuff. They don't seem to have any notion of task dependencies. Also I'm shocked that they didn't think through staffing and realize that their therapists may leave, get ill, take holiday or have maternity leave.
 
Sly Saint said:
SW always insists he had 'nothing to do with the PACE trial'
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This is what he said about his involvement with PACE (https://www.nationalelfservice.net/...syndrome-choppy-seas-but-a-prosperous-voyage/):
I was not on the ship [HMS PACE], neither as passenger or crew. I helped recruit some patients to the study from our clinic, as did many doctors, but that was as far as it went. I am not an author on the ship’s log, but I am not a neutral observer. I know a lot about how these ships sail (Everitt and Wessely, 2003). I know a lot about the passengers, those with the illness known as chronic fatigue syndrome (CFS), because I have seen what must be a few thousand now as a doctor who used to research the illness and continues to see sufferers in the clinic. I have done a few voyages similar to the one undertaken by PACE (e.g. Deale et al, 1997), but not in such a large and complex boat, at least not for this illness. I also make no secret of the fact that I know some members of the crew well. I have worked happily with many of them over the years, and in particular I consider the most senior officers on board this particular ship to be personal friends. Do I have competing interests? Sure I do.
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Indigophoton said:
So given all that, I suspect Horton saw publishing PACE as a great scoop both scientifically [sic] and politically: it's not just a trial about CFS, but a key piece of evidence [sic] supporting the use of the BPS model for welfare reform.
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Very likely. Or that he had been persuaded this was going to be newsworthy by someone with charisma who he thought worth backing. Like the SMC people I see no consistency of philosophy - just commitment to propaganda for its own sake.
 
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