Tribunal orders QMUL to release anonymised PACE data 16 Aug 2016

[worldbackwards]

QMUL...now argues that disclosure would undermine the entire ethical and regulatory framework for clinical research and deter future participation in clinical trials.

This Tribunal is of the view that this must be an overstatement, as it seems previous FOIA disclosure of information relating to these trials did not have that apocalyptic effect.

Top trolling from the Tribunal.

 

[Dolphin]

.
@Chrisb the UK DWP put in 1£million to the PACE Trial. The rest of the £5 million funding was from the MRC and a Scottish org whose name I can't remember. The original amount from the MRC announced in 2004 (ish) was £1.6 million

Where did you hear that the Department of Work and Pensions paid £1,000,000?
I have never seen a figure but the figures I saw suggested they gave maybe £100,000-200,000

=====Source 1 =====

http://tinyurl.com/ydsv857
i.e.
http://www.rae.ac.uk/submissions/ra5a.aspx?id=176&type=hei&subid=3181

You are in: Submissions > Select unit of assessment > UOA 9 Psychiatry,
Neuroscience and Clinical Psychology > University of Edinburgh > RA5a UOA 9 -
Psychiatry, Neuroscience and Clinical Psychology University of Edinburgh

[..]

"the PACE trial (7 UK centres) of chronic fatigue syndrome (CFS) treatments
(MRC; £5.0M);"

=====Source 2 =====

From figures below:
£2,076,363
£1,800,600
£702,975
£250,000
------
£4,829,938 + DWP money (unknown)


(Yes this is the same web page but it is a summary of a different entry)

http://tinyurl.com/ydsv857
i.e.
http://www.rae.ac.uk/submissions/ra5a.aspx?id=176&type=hei&subid=3181

You are in: Submissions > Select institution > Queen Mary, University of
London > UOA 9 - Psychiatry, Neuroscience and Clinical Psychology > RA5a Queen
Mary, University of LondonUOA 9 - Psychiatry, Neuroscience and Clinical
Psychology
RA5a: Research environment and esteem

[..]

White showed that recovery from CFS is possible following CBT (Knoop et al,
2007). The MRC funded PACE trial, led by White , evaluates CBT, graded
exercise, adaptive pacing and usual medical care in the treatment of CFS, and
is over half-way completed (http://www.pacetrial.org/) (PACE trial MRC
04-09 £2,076,363, DH Central Subvention 04-09 £1,800,600; MRC PACE trial
extension 09-10 £702,975).

==================

SCOTTISH PARLIAMENT - WRITTEN ANSWER

2 December 2005

Health Department

Janis Hughes (Glasgow Rutherglen) (Lab): To ask the Scottish Executive what
funding it has awarded for chronic fatigue syndrome/myalgic encephalomyelitis
(CFS/ME) services or research since the CFS/ME short-life working group
reported in 2002.

(S2W-20924)
Lewis Macdonald:

NHS Boards are given unified budgets, increased by an average of 7.6% in the
current financial year, from which they are expected to meet the costs of
services for people with CFS/ME and all other chronic conditions. It is for
NHS Boards to decide how their unified budgets should be distributed, based on
their assessments of local needs.

The Chief Scientist Office (CSO), within the Scottish Executive Health
Department, has responsibility for encouraging and supporting research into
health and health care needs in Scotland. CSO is currently contributing
£250,000 to the Medical Research Council project 'Pacing, Activity and
Cognitive behaviour therapy: a randomised Evaluation (PACE)' which compares
different approaches to the clinical management of patients with CFS/ME.

 

[Snowdrop]

@worldbackwards

I'm afraid I'm not following this. What is it you are quoting?

 

[worldbackwards]

@worldbackwards

I'm afraid I'm not following this. What is it you are quoting?

That's from page 28, the Tribunal's response to QMUL's submissions on April 14th

 

[worldbackwards]

Contrast instead Professor Chalder's evidence when she accepts that unpleasant things have been said to and about PACE researchers only, but that no threats have been made either to researchers or participants. The highest she could put it was that some participants stated that they had been made to feel "uncomfortable" as a result of their contact with and treatment from her, not because of their participation in the trial per se.

Well, that speaks volumes.

There is no evidence either of a campaign to identify participants nor even of a risk of an 'insider threat'. Combining Information sources to identify Generic references to 'social media' and non-specific assertions that there is "so much information out there" are insufficient to assist in this appeal.

 

[JaimeS]

As I've said a few times now, So Much Sass. I want to buy the whole Tribunal a beer.

 

[Wildcat]

@Dolphin - you wrote "
"Where did you hear that the Department of Work and Pensions paid £1,000,000?
I have never seen a figure but the figures I saw suggested they gave maybe £100,000-200,000"

I can't remember where I saw that figure, and have been looking for the document ... so I have amended my post as the amount is in dispute.

I guess it would take another FOI to the DWP to ask them to confirm the exact figure.

.

 

[user9876]

One of QMUL's witnesses (Prof Thornton who is the new dean of the medical school) claims

It is generally accepted that data from clinical trials be made available for further analysis but only to bona fide researchers with a prespecified statistical analysis methodology who are prepared to publish data once analysed and are part of a research organisation, and where confidentiality of patients is assured. The most important reason to restrict the dissemination of data in this way is to prevent spurious results from analysis without prespecified methodology or peer reviews.

I was thinking that maybe he was old fashioned and had not come across journals such as PLOS that insist on datasets made available for papers and now they need to be submitted with the paper. But I did look to see if he had published anything on PLOS and he has published a paper there (only as the last author) http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0030169. What is maybe interesting is that there is also an editorial where this data is re-analysed http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0030276 which points out that they deposited the data in a public repository http://www.ebi.ac.uk/arrayexpress/experiments/E-MEXP-106/

So maybe Steven Thornton has forgotten about this or considered this unusual. But it doesn't seem to fit with what he says in his witness statement.

I also wondered if White had told him how much they went away from their presecified analysis plan (i.e. their protocol)

 

[Snowdrop]

@worldbackwards

Ahh, thanks, I tend to loose the thread.

 

[GreyOwl]

There are two potential new avenues of investigation coming out of this:

1. Follow up with DWP to confirm whether P White accepted funds from them in any capacity during the PACE trial, or during the pre-trial period when funds were being awarded, as per @Keith Geraghty's suggestion.
2. Follow up with Cochrane about the status of their "independent" review now that T Chalder has admitted this review was not independent at all, as per @Hutan's suggestion.

Any takers? I can write letters for others, but am not in the UK (for point 1) and have no standing in those circles (for point 2) to undertake these tasks in my own name.

 

[Dolphin]

London Tribunal Orders Release of PACE Trial Data

Piece by Solve ME/CFS Initiative

http://solvecfs.org/london-tribunal-orders-release-of-pace-trial-data/

 

[user9876]

Another of QMUL's witnesses was
Dr Frances Rawle – Head of Corporate Governance and Policy, Medical Research Council

who said

MRC funded the PACE trial through a research grant, but does not own or retain any rights to the data generated but expects all data to be processed in accordance with the consent given by participants. The PACE trial was not obliged to submit to MRC a data management plan as it was approved prior to the commencement of that policy, but the MRC would expect all requests for data to be considered by the research team and implemented in such a way as to guarantee compliance with the terms of the participants' consent.

Reidentification has been a concern for an advisory group on data access established by funders of public health and genetics research, given the widening use of administrative data and individuals releasing more information about themselves on social media. CFS/ME is currently underresearched, and uncontrolled disclosure of information could damage participation of patients in future research.

She seems to be doing her best to say the release of data would harm further research. I wonder if she mentioned that (has head of governance) she had failed to act on complaints about the PACE trial from Hooper http://forums.phoenixrising.me/inde...e-from-the-mrc-to-hooper-pace-complaint.8867/ . She seemed to dismiss any concerns about the newsletter promoting particular treatments and also seemed happy with the outcome switching. In her reply to Hooper she says:

4. I acknowledge that there have been changes to the protocol for the PACE trial since it started. It is not uncommon for minor protocol modifications to be made while a trial is in progress; all such modifications must be approved by the Trial Steering Committee (TSC), the Data Monitoring and Ethics Committee, and the MREC that approved the original protocol, and they were in this case. In addition, the MRC Board was aware of the changes when it agreed to the extension to the original funding period for the trial, so clearly the Board did not consider the changes undermined the trial.

So a witness who could be embarrassed by the release of any data that lets the extent of the effect of protocol changes to be examined.

 

[Michelle]

As much as I am totally excited, happy, etc, I am fucking pissed man. How many newspaper articles, journal articles and other various scientific/non-scientific outlets reported on the claims of death threats and threats of violence against researchers by us. The whole god damned thing was totally fabricated by the researchers and the school. It was a lie that was reported to the media to foward their agendas the harm of patients. That sounds illegal. I wish there was some legal recourse we as a community could take (maybe there is).
It's unbelievable how weak QMUL's defense was it really makes you wonder what they're hiding. I can not wait to see what gets dug up once people start going through the data.

If I'm reading correctly the Tribunal's opinion (lol and that's always a big IF ), I think all we know from Dr. Chalder's comments is that none of the authors of the PACE trial faced anything more than a lone heckler. Sir Simon, otoh, is not an author on the PACE trial and has been the most visible face of the BPS school over the years (i.e. the "Wessley School"). Thus, he may well have received a death threat. The other researcher to figure prominently in the media attack on patients was that woman from Bristol (whose name escapes me at the moment). Her claim was that she had been accused of child abuse by some patients on online -- a nasty accusation to be sure, but given the situation, hardly a surprising one. I remember at the time thinking that if she truly believed she was really helping her patients, she should grow a thicker skin. To ask nothing of why the hell does she care what a group of patients who clearly are not "mentally well" think about her anyway?

Anyhoo, what IS clear is the whole "violent, militant ME patients" story was clearly an intentional, well-spun case of Mountains & Molehills (and a well-established media tool very much used in the current media climates in both the UK & US). But doing it to very sick patients whilst forcing on them a potentially harmful therapy even as you help suppress research on potentially helpful therapies, whilst also advising DWP and Swiss Re to deny benefits to these sick patients is just dickishness piled on dickishness buried under a steaming pile of dickish bullshit.

 

[Snowdrop]

Yes, Esther Crawley and her SMILE trial. I wonder what kind of impact the tribunals decision on PACE will have?
Hopefully a frozen SMILE.
Sick children deserve better. If she doesn't like hearing it she can find some other work.

Edit to add that I was corrected. It is the MAGENTA trial that is now ongoing the SMILE trial is complete.

 

[AR68]

Don't forget section (iv) of the majority decision (on page 40). "It was clear that (Professor Anderson's) assessment of activist behaviour was, in our view, grossly exaggerated and the only actual evidence was that an individual at a seminar had heckled Professor Chalder."

It's now on record that when the PACE lobby were asked to produce evidence of a campaign of harassment, the best they could manage was an isolated incident of heckling. This decision should be *very* helpful the next time anyone needs to rebut the SMC's wild claims about "ME militants"

Hello, first post for me. Wasn't planning on subscribing to PR but when I saw the discussion on the PACE tribunal I felt I had to say something.

I attended all of the public sessions so have a fair experience of the case. However, we more or less stopped taking notes early on and, because of my short term memory problems, cannot go into great detail regarding anything in the last two and a half days unfortunately.

Anderson gave his evidence on the morning of the second day, first day being Chalder, Thornton and Rawle. As has been pointed out, Anderson essentially gave a 'risk assessment'. However, I feel his contribution was pivotal.

Anderson exaggerated. I feel I can say that since it comes out in the judgment. He appeared to me rather sure of himself perhaps bordering on arrogant. QMUL appeared to had taken a gamble - which backfired.

He essentially likened the patient community to radicals and extremists. Personally I thought his evidence was disgraceful in its denigration.

I noted with interest Simon Wessely rather distancing himself on Twitter from Anderson.

One note that I will add that has already been said on more than one occasion - social media was, and probably still is, being monitored. Twitter and PR were mentioned during the case.

 

[AR68]

thanks @Stewart, I read that when I was skimming the pdf but could not find it when it came time to write a comment.

and it is kind of genius isn't it. On record, in front of people who cross-examine them all that nonsense just evaporates. I wish we had a transcript or video.

And journalists who a) gave a damn, and b) were upset about being mislead.

Very frustrating. Half a day into it we more or less stopped taking notes. It was never entirely clear what we could or couldn't do other than we were forbidden from taking "verbatim" notes - quotes etc. The situation was made somewhat clearer on the second day after the impressive Mr. Paines got us some clarification on the matter but for some of us it was too late.

Breaking of the rules would have meant contempt of court.

 

[AR68]

Who is this Prof Anderson fellow? And what planet is he from?

View attachment 16747

A CFS activist insider involved in a BPS project? Not that they'd be hard to spot - it's the person shuffling around like a zombie looking dazed and babbling a load of nonsense. Hang on a minute - that just might be the perfect cover ...

And rich indeed, considering the BPS insider members we have on PR, reading and reporting back on everything ...

Having heard Anderson's evidence, "exaggerated" and "supposition" were accurate.

 

[AR68]

James Coyne weighs in, diplomatic as ever:


https://jcoynester.wordpress.com/2016/08/16/tribunal-orders-release-of-pace-trial-data/

I can just imagine the conversation:

"Trudie, they've dismissed our concerns of the patient community, easy the weakest and most easily smeared of all our opponents. What do we do now?"
"Okay Pete, how about...we launch an attack on a respected researcher who's sited far more often that we are because he can be a bit of a nob?"
"Sounds like a plan!"

On a more serious level, I find it incomprehensible that the arguments that were so clearly deficient (and so horribly exposed) here were taken so seriously in response to the requests of @Graham and others. How on earth can they justify turning down a request for a tiny amount of data underpinning a graph that was already in the public domain, then turn round and demolish exactly the same arguments, posed in both desperation and anger, against a claim that amounted to pretty much everything? It really doesn't make any sense. Does anyone in the ICO actually talk to each other?

Just a little note that Chalder did take a mild swipe at Coyne by questioning his 'seriousness'. A rather glib and unprofessional remark.

 

[AR68]

QMUL's statement:


http://www.qmul.ac.uk/media/news/items/smd/179331.html

It's self-preservation.

 

[AR68]

One of QMUL's witnesses (Prof Thornton who is the new dean of the medical school) claims


I was thinking that maybe he was old fashioned and had not come across journals such as PLOS that insist on datasets made available for papers and now they need to be submitted with the paper. But I did look to see if he had published anything on PLOS and he has published a paper there (only as the last author) http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0030169. What is maybe interesting is that there is also an editorial where this data is re-analysed http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0030276 which points out that they deposited the data in a public repository http://www.ebi.ac.uk/arrayexpress/experiments/E-MEXP-106/

So maybe Steven Thornton has forgotten about this or considered this unusual. But it doesn't seem to fit with what he says in his witness statement.

I also wondered if White had told him how much they went away from their presecified analysis plan (i.e. their protocol)

At one point Paines accused Thornton of not answering questions.