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‘Academic freedom’ overrides individual concerns in PACE Trial tribunal

Discussion in 'General ME/CFS News' started by Firestormm, Aug 24, 2013.

  1. Firestormm

    Firestormm Guest

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  2. Esther12

    Esther12 Senior Member

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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.
     
  3. Esther12

    Esther12 Senior Member

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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:

    Action for ME screwing patients over again.


    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:


    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.

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

    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!:

    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.
     
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  4. Firestormm

    Firestormm Guest

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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 :)
     
  5. Dolphin

    Dolphin Senior Member

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

    Firestormm Guest

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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...
     
  7. Dolphin

    Dolphin Senior Member

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    No, Fraser brought a judicial review case against NICE.

    I think that bit refers to related legal cases/rulings.
     
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  8. Esther12

    Esther12 Senior Member

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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.
     
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  9. Legendrew

    Legendrew Content team

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    If you've got nothing to hide, you've got nothing to fear...
     
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  10. biophile

    biophile Places I'd rather be.

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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."
     
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  11. Simon

    Simon

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    from Tony Britton on 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.
     
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  12. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    Almost like us cfs/me people have weapons of mass destruction.
     
  13. Firestormm

    Firestormm Guest

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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 :)
     
  14. Simon

    Simon

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    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.
     
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  15. biophile

    biophile Places I'd rather be.

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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.
     
  16. Dolphin

    Dolphin Senior Member

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    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:
    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.
     
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  17. Bob

    Bob

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    If three words are deleted, then the tribunal did at least get one thing right:

    How ironic that Queen Mary have refused to release the data set out in the protocol:
     
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  18. Bob

    Bob

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    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.
     
  19. biophile

    biophile Places I'd rather be.

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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.
     
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  20. Esther12

    Esther12 Senior Member

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    I don't think that there's any way to appeal this judgement, but it is an embarrassing piece of work.
     
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