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‘Academic freedom’ overrides individual concerns in PACE Trial tribunal

Firestormm

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‘Academic freedom’ overrides individual concerns in PACE Trial tribunal | 24 August 2013

by Tony Britton on August 24, 2013

A judicial tribunal this week backed the rights of universities not to publish the detailed discussions of their research committees when it ruled that both the Information Commissioner and Queen Mary University of London were correct not to accede to demands to open up the minutes of the highly controversial, £5m PACE Trial to public scrutiny.

In a reserved judgement handed down on Thursday (August 22), Judge Christopher Hughes and two lay colleagues sitting as a first-tier tribunal said the need to underpin academic freedom overrode the rights of individuals under the Freedom of Information Act to highly detailed disclosures about the way research decisions were made.

They dismissed an appeal by John Mitchell, who had made an FoI request for Queen Mary to publish minutes of the PACE Trial steering committee and management groups, despite being aware that an identical request had already been rejected.

According to evidence seen by the Tribunal, Mr Mitchell wanted to know why there were differences between outcomes predicted in the trial protocol and the ultimate results. Professor Peter White, one of the lead investigators, informed the tribunal that Mr Mitchell also had implied there was collusion between government, funders or researchers.

Read more...

Download decision here.
 
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Hmmm. Sounds like another lengthy document I'd Iike to read.

edited: My initial post here was barely comprehensible, now removed! Edit 2: Also, the decision really isn't very long.
 
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A lot of emphasis in the intro was placed on the 'harassment' theme - despite no evidence of anything unreasonable from the person who was appealing the FOI.

They've worked very hard to try to portray criticism of PACE, or requests for information, as innately unreasonable. Looks like this Judge decided to join them in their lazy and self-serving prejudices.

Was the Judge even aware that the researchers are refusing to release the outcome measures they laid out in their own protocol? Or that a trials protocol is used to lay out in advance what data will be released? From what I remember from the earlier judgement, this was a core part of Mr Mitchell's complaint:

The research and its findings had been fully and promptly published in the Lancet with access to the findings fully available to the public. These findings have been subject to an extraordinary level of public scrutiny and in response to public commentary the Lancet had subjected the study to a further review process.
In this case there was an ongoing process of research and it was therefore important to continue to protect the free and frank exchange of views in such studies in order to continue to protect academic freedom. Correspondence from a patient representative group submitted by Queen Mary indicated that publication of minutes would have a negative impact on its willingness to participate in the future in such work

Action for ME screwing patients over again.


15. In particular Queen Mary drew attention to a judicial review heard in the High Court in 2009 in which a challenge was brought against the National Institute for Health and Clinical Excellence in connection with the development of guidelines for the treatment of CFS/ME.
Fraser & Anor, R (on the application of) v National Institute for Health and Clinical Excellence & Ors [2009] EW HC 452 (Admin) (13 March 2009) In an afterword to that ruling Mr Justice Simon noted:-

I've seen the PACE lot try to present these findings as definitive previously, so it must really say what they want. I don't actually know much about this case, as it took place before I was really reading much CFS stuff. Was this a big thing that was a fair representation of the available evidence, or just a couple of patients making a complaint on their own that included some unfounded claims? Also, there are things like the Parliamentary Gibson Enquiry which reached quite different conclusions about concern over links to the insurance industry.

It wouldn't surprise me if a lazy judge had just assumed that the conclusions of this one case were a definitive representation of the state of play around CFS controversies, so as to avoid having to look at, or think seriously about, the complicated and uncertain evidence.

White talks about briefing members of the House of Lords for their PACE debate:

In particular, I had to recently brief several members of the House of Lords so that they might speak in a critical debate about the Pace trial held on 6th February this year (exhibit C)


The abusive e-mails don't seem that abusive to me. Not something I'd send of course, but really, is this any worse than claiming that CFS patient's symptoms are influenced by a desire to maintain the secondary gain that comes with the adoption of the sickness role? Seems less serious, given the different power relationships involved.

25. An examination of the emails attached to his second witness statement reveal the vituperative and abusive way in which some activists behave towards researchers:-

“Has it always been just to cuckold others,
to show perceived superiority, and to keep
a small contingent gainfully employed?
Because not a whit of it has been based on any PROVEN SCIENCE! .

Looks like this bit falls into bigotry, and from what I've seen, a serious misrepresentation of Mr Mitchell's views:

Consideration
27. What is immediately apparent in considering this request for information is the extent to which the request is part of a campaign which has now extended to the use of FOIA as a means of advancing an argument which in essence has roots in clinical medicine and in a black and white view of the mind/ body problem. There is a view among some members of the CFS/ME community that the distressing disorder which they suffer from has a simple and straightforward physical cause which if properly researched will lead to a cure. They view any diversion from that as wasteful and indeed duplicitous.

All too often such requests are likely to be motivated by a desire not to have information but a desire to divert and improperly undermine the research and public ation process – in football terminology– playing the man and not the ball. This is especially true where information is being sought as part of a campaign – it is not sought in an open-minded search for the truth – rather to impose the views and values of the requester on the researcher

Yeah - if only PACE had pre-published some sort of guidance on what they were going to publish, so that they could be held to that, and avoid accusations of spinning data.... like the ruddy protocol!:

35. The second issue relates to the strategy which universities faced with the
likelihood of a high degree of hostile attention in connection
with research (or indeed a high degree of public interest) could adopt
in order to protect the highly valuable time and energy of their researchers while
at the same time giving a high degree of transparency and accountability to what is done. Public authorities have a duty under section 19 of FOIA to adopt, maintain and from time to time review a publication scheme. In this case there has been a very high degree of transparency both in the initial publication of the research protocol and indeed in the exhaustive work of the researchers and the Lancet in publication of the material. However it might well be worth considering at the start of a major project such as this setting out a publication strategy identifying what materials will be produced in the course of the project, which materials will be published and when (this will enable s22 to be considered if FOIA requests are received for such material), and which are unlikely to be published under FOIA as exemptions may be engaged.


While individual publication strategies will be specific to the project,this is an area that would clearly benefit from guidance to Universities by the Commissioner indischarge of his article 13 duties.

The tribunal has no doubt that properly viewed in its context, this request should have been seen as vexatious- it was not a true request for information-rather its function was largely polemical and as such in the light of recent Upper Tribunal judgements might have been more efficiently and effectively handled if treated as vexatious

This is a ruling that seems based on attitude, instinctive deference to authority, and prejudice about CFS patients who want access to information about the efficacy of the treatments available for their condition. It seems devoid of any attempt to grapple with the evidence, of the specific problems with the way in which results from PACE were presented. I had been somewhat impressed by some of the past FOI rulings I had read, but this one does much more to live up to the negative stereotypes of the British Judiciary.
 

Firestormm

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Esther12 I think you will find Mitchell was the barrister representing the complainant. So it might also be a case of the barrister not doing as good a job with his presentation of evidence as could be hoped if one had, say, a limitless wallet? Though I am not sure how this was financed of course. I did read it all through but still can't make head nor tail of it yet. Well done you :)
 

Dolphin

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Esther12 I think you will find Mitchell was the barrister representing the complainant. So it might also be a case of the barrister not doing as good a job with his presentation of evidence as could be hoped if one had, say, a limitless wallet? Though I am not sure how this was financed of course. I did read it all through but still can't make head nor tail of it yet. Well done you :)

No, John Mitchell isn't the barrister, he's the person who took the case.
 

Dolphin

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Maybe I'm reading it wrong then but I had heard Fraser previously bringing an FOI case and thought this his appeal. Oh well...

No, Fraser brought a judicial review case against NICE.

I think that bit refers to related legal cases/rulings.
 
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I'd have thought most patients would end up representing themselves on things like this.

This judgement is pretty disgusting. There are other things in it which I probably should have pulled out too, but did not. As an illustration of how CFS patients pursuing the truth are viewed and treated, I think it's valuable and shameful.
 

biophile

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I skimmed through it earlier when it appeared on Co-Cure. The document makes numerous referrals to extremism and also implies that this FOI request could also be interpreted as a form of harassment from co-ordinated activists. If someone is suspecting foul play (rightly or wrongly), that does not automatically mean that they are not searching for truth! In fact it is suspicions with the science and the motives that is driving people to seek the truth.

I think it would be unhelpful to assume and claim that PACE consciously changed the protocol after seeing the data. I would not be surprised if I was wrong, but I will generally take their word that changes were done before seeing the data. However, experimenters' bias is often subconscious, and the researchers were not blinded to the allocation of participants, nor where they necessarily shielded from any external cues as to how the trial was going.

White said, "If we knew the answers setting out, there would be no need for the trial in the first place."

What about getting paid, receiving laurels, resolving the safety controversy, crushing the competition, and enshrining one's pet approach in "evidence-based medicine"? If I was a crafty quack I would certainly want to secure 5 million pounds of funding and gerrymander the protocol to get the expected results and publish in the Lancet (not saying that happened).

Critics of the PACE Trial understandably want a better explanation for the questionable changes to protocol. There have only been vague references to improving the interpretation, but there has been no comparison to previous goalposts or adequate arguments for why the new goalposts are better. The analysis plan has still not been published despite being promised several years ago. The next obvious source of explanation is the meeting minutes.

Once you realize that the normal physical function threshold in particular is a retractable offense, ongoing talk of how robust and rigorous the science of PACE was in their quest to improve the interpretation of the results is like praising a show sheep that is parading around with a huge dag region between its back legs.

"The research and its findings had been fully and promptly published in the Lancet with access to the findings fully available to the public. These findings have been subject to an extraordinary level of public scrutiny and in response to public commentary the Lancet had subjected the study to a further review process."

The results were not "fully" published in the Lancet. The comment on the additional peer review just makes it worse. It means that the Lancet failed to spot any errors even though these errors were being pointed out to them repeatedly. Considering the flaws with normal physical function I thought this comment was also amusing:

"At all times the methods used ensured a very high level of scrutiny for integrity and scientific rigour."
 

Simon

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from Tony Britton on the MEA website:
Judge Hughes wrote: “The tribunal considers that the underpinning given to academic freedom within both the UK State Law and Human Rights Conventions should be fully recognised and given appropriate weight in considering applications such as this.”
He added:
“In a real sense, the structures of a university are designed to support this dissemination of information in the most effective means possible, in particular the dissemination of research through the processes of publication in scientific journals. A parallel process of dissemination through FoIA is unlikely to be as effective or robust as the process of lectures, seminars, conferences and publications which are the lifeblood of the university.“They are likely to be a diversion from the effective evaluation, publication and scrutiny of research through the academic processes.”​
Clearly Judge Hughes does not follow James Coyne on twitter.

But really, this is demonstrably wrong. The AllTrials campaign for registration and full reporting of all clinical trials, past and present, is backed by plenty of scientists as well as the BMJ, Wellcome Trust etc. Full release of all data is called for by the Wellcome Trust and backed by UK minister David Willetts (comment). And top journals including Nature and Science regularly feature pieces about poor, inaccurate and selective reporting in science (Nature eg). Even psychology is going to great lengths to clean up its act. The untrustworthyness of much published research is probably the topic in Life Sciences over the last couple of years.

That said, I think this FOI request was misguided as it was clearly a fishing trip, rather than a focused request for information. The pity is, the above ruling might then be used to defend against future FOI requests - though I think there would be very strong grounds for appeal if it were.
 

Firestormm

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from the MEA website:

Clearly Judge Hughes does not follow James Coyne on twitter.

But really, this is demonstrably wrong. The AllTrials campaign for registration and full reporting of all clinical trials, past and present, is backed by plenty of scientists as well as the BMJ, Wellcome Trust etc. Full release of all data is called for by the Wellcome Trust and backed by UK minister David Willetts (comment). And top journals including Nature and Science regularly feature pieces about poor, inaccurate and selective reporting in science (Nature eg). Even psychology is going to great lengths to clean up its act. The untrustworthyness of much published research is probably the topic in Life Sciences over the last couple of years.

That said, I think this FOI request was misguided as it was clearly a fishing trip, rather than a focused request for information. The pity is, the above ruling might then be used to defend against future FOI requests - though I think there would be very strong grounds for appeal if it were.

Simon, wasn't at least part of the appeal asking for minutes of meetings and not therefore data connected to this research? I mean such information would not readily become part of any 'full release of all data' or what the AllTrial campaign is asking for - is it? There must be some protection for academics and scientists: or do you think everything they say - and who says it regardless of who they are in a meeting - should be made publicly available? Thanks and nice post :)
 

Simon

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Simon, wasn't at least part of the appeal asking for minutes of meetings and not therefore data connected to this research? I mean such information would not readily become part of any 'full release of all data' or what the AllTrial campaign is asking for - is it? There must be some protection for academics and scientists: or do you think everything they say - and who says it regardless of who they are in a meeting - should be made publicly available? Thanks and nice post :)
Maybe wasn't clear: I was only commenting on that specific part of the ruling (quoted above) as it might be relevant to future FOI requests, and does imply you can trust researchers to release the data that is relevant. FOI rulings already provide quite a bit of protection from requests for blanket disclosure of discussions, and I don't have a problem with that.
 

biophile

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What exactly is the Norway Cochrane re-analysis of the PACE data supposed to achieve?

[Edit: I am not sure if this is just the next update or a special edition just for PACE.]

Unless a major error is uncovered or the re-analysis is going to use different thresholds (such as the ones set out in the original protocol), then merely redoing the same analysis is just going to confirm the previous one, adding nothing to the debate except another round of back-patting from the ivory towers.

Is it supposed to demonstrate that PACE did not fake data or that they are not incompetent?

A faker would have already cleverly faked the data and then just sent that over. I do not believe the data was faked, and I doubt anyone seriously believes it was. What critics are really objecting to is the post-hoc protocol changes, the inadequate justification and lack of details, and possibly the timing and potential COI. On the issue of incompetence, the threshold for normal physical function certainly reflects poorly enough on the researchers and professionals involved.

Objections have also been raised which have nothing to do with the data itself, such as the nature of the improvements, the interpretation of the results, and the generalizability of the cohort. The Norway Cochrane re-analysis of PACE data will probably function as a good publicity stunt while failing to address the key criticisms.
 

Dolphin

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What exactly is the Norway Cochrane re-analysis of the PACE data supposed to achieve?

Unless a major error is uncovered or the re-analysis is going to use different thresholds (such as the ones set out in the original protocol), then merely redoing the same analysis is just going to confirm the previous one, adding nothing to the debate except another round of back-patting from the ivory towers.

Is it supposed to demonstrate that PACE did not fake data or that they are not incompetent?

A faker would have already cleverly faked the data and then just sent that over. I do not believe the data was faked, and I doubt anyone seriously believes it was. What critics are really objecting to is the post-hoc protocol changes, the inadequate justification and lack of details, and possibly the timing and potential COI. On the issue of incompetence, the threshold for normal physical function certainly reflects poorly enough on the researchers and professionals involved.

Objections have also been raised which have nothing to do with the data itself, such as the nature of the improvements, the interpretation of the results, and the generalizability of the cohort. The Norway Cochrane re-analysis of PACE data will probably function as a good publicity stunt while failing to address the key criticisms.
In theory, the Cochrane Review can highlight outcome measures that were not published.

For example, in the first Cochrane review on CBT for CFS, they highlighted:
There were some other de ciencies in published data, such as Sharpe (Sharpe 1996) not reporting improvement in employment status despite stating the intention to use this as a subsidiary measure of functioning. These data are still awaited.
Although this was mysteriously dropped from the second Cochrane review on CBT for CFS even though they didn't publish the data (although it did eventually appear I think in a later edition).

I'm not an expert on Cochrane reviews. I think they are starting to look at patient input. So there might be possibilities to raise issues.

The fact that Peter White mentioned the Cochrane review, and Simon Wessely also mentioned it on Twitter, makes me think they're not too worried about it. I remember the Cochrane review on GET for CFS thanked Peter White for all the help he gave with the analysis/similar. That's a bit like asking a drug company rep to help with the analysis of a drug.
 

Bob

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If three words are deleted, then the tribunal did at least get one thing right:
The tribunal ruling said:
There is a view among some members of the CFS/ME community that the distressing disorder which they suffer from has a simple and straightforward physical cause which if properly researched will lead to a cure.


How ironic that Queen Mary have refused to release the data set out in the protocol:
The tribunal ruling said:
...it might well be worth considering at the start of a major project such as this setting out a publication strategy identifying what materials will be produced in the course of the project, which materials will be published and when (this will enable s22 to be considered if FOIA requests are received for such material)
 

Bob

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What exactly is the Norway Cochrane re-analysis of the PACE data supposed to achieve?

Unless a major error is uncovered or the re-analysis is going to use different thresholds (such as the ones set out in the original protocol), then merely redoing the same analysis is just going to confirm the previous one, adding nothing to the debate except another round of back-patting from the ivory towers.

Is it supposed to demonstrate that PACE did not fake data or that they are not incompetent?

A faker would have already cleverly faked the data and then just sent that over. I do not believe the data was faked, and I doubt anyone seriously believes it was. What critics are really objecting to is the post-hoc protocol changes, the inadequate justification and lack of details, and possibly the timing and potential COI. On the issue of incompetence, the threshold for normal physical function certainly reflects poorly enough on the researchers and professionals involved.

Objections have also been raised which have nothing to do with the data itself, such as the nature of the improvements, the interpretation of the results, and the generalizability of the cohort. The Norway Cochrane re-analysis of PACE data will probably function as a good publicity stunt while failing to address the key criticisms.

I agree. It seems pointless. My (limited) understanding is that, in essence, Cochrane reviews extract the existing published data, and simply re-publish it. With perhaps some minor comments in the small print about some minor weaknesses in the methodology of the study. (Although I've only ever read their meta-analyses papers, and perhaps a single-trial analysis might be different.) The don't tend to carry out a broad analyse of a subject, but just re-analyse the existing data. At least, this seems to be the case for the CBT/GET studies in relation to CFS that I've read. I can't imagine it being anything other than an old-boys slap on the back, which confirms the PACE trial authors' analysis and conclusions. The PACE trial authors will then publicise the Cochrane review with enormous (self-congratulatory) fan-fare, and promote it as confirmation of a wonderfully executed, irreproachable 'gold-standard' medical trial.
 

biophile

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I am not sure if this is just the next updated review for either CBT or GET or both (there have not been any for a long time) or if this is a special edition just for the PACE Trial data. I guess most of my previous post was for the latter. The previous Cochrane reviews did have occasionally frank conclusions and interesting commentary.