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PD White's efforts to stop a researcher accessing PACE Trial* data (cost:£5m of UK taxpayers' money)

Discussion in 'General ME/CFS News' started by Tom Kindlon, Jul 9, 2014.

  1. Tom Kindlon

    Tom Kindlon Senior Member

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    From the minutes of the Forward M.E. meeting held at the House of Lords on 10 June are nowavailable to view and download online.


    http://www.actionforme.org.uk/Resources/Action%20for%20ME/Documents/forward-me-10-jun-14.pdf

    ---


    ---

    I believe the most likely reason for this behaviour is that PD White is concerned that if others get the data, they will see a different version of the results to what has been presented e.g. that the recovery rate as defined in the published protocol would be, percentage-wise, in (say) single figures.

    This isn't the only example of attempt to refuse to release the data - numerous freedom of information act requests have been refused.

    I don't think PD White and the PACE Trial team should be rewarded for their behaviour by people giving up trying to get the data. Instead, I think it should encourage people to try even harder to ensure the data is released. This trial cost £5m of public money. As the statistical analysis plan said, it was supposed to be a "definitive" trial. In this era of open data, the investigators should not be allowed continue with all the attempts they have made to refuse to release data such as their refusal to release the data on the recovery definition as described in their own published protocol (not the ridiculous definition they published on where people could be classed as recovered with a SF-36 physical functioning score of 60, less than the trial entry criterion!)
     
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  2. SilverbladeTE

    SilverbladeTE Senior Member

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    if they won't release data from a publicly funded trial, then the entire thing smacks of fraud, sod 'em

    only personal and confidential commercial data (such as a drug's manufacturing process but not it's chemical nature) should be allowed to be held secret in medical trials
     
  3. Esther12

    Esther12 Senior Member

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    Would be interesting to see what is being counted as harassment.
     
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  4. user9876

    user9876 Senior Member

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    It would also be interesting to know the legal position if Barts are using the PACE trial figures to sell a service to clinical commissioners. As I understand it the NHS contracts are now commercial. I think it is particularly interesting with respect to any recovery figures that they quote since the way they are calculated is so stupid. I don't see how they could argue having recovery thresholds below trial entry thresholds is reasonable.

    They have made careers pushing these ideas and also Barts is charging for the treatments so I'm not surprised they are suppressing the results. I wonder why those in the medical community have not noticed or spoken out but to misquote Tebbit's recent comment 'the collective instinct of establishment figures at the time was to protect "the system" and not to delve too deeply into claims'.
     
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  5. anciendaze

    anciendaze Senior Member

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    So far as I know, we have no data to show that they actually counted people whose scores declined as recovered, only that such an interpretation is possible. We also don't know that this did not happen. I think the idea that checking data counts as harassment indicates this is a sensitive subject for P.D. White. More than this very few people are in any position to say, and that seems to be entirely satisfactory for some. Coupled with dropping objective activity measures listed in the proposal for PACE this fits a pattern.
     
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  6. user9876

    user9876 Senior Member

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    I don't think it matters whether a patient deteriorated and got classified as recovered the point is setting the thresholds in a way that allows this indicates they are using an absurd definition of recovery and one so far off recovered that it should have been obvious to them.
     
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  7. Dolphin

    Dolphin Senior Member

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    One of the letters in reply to the paper brought up about the recovery criteria being worse than the entry criteria:

    but the authors didn't say anything about such a scenario not being possible, nor in the original Psych Medicine paper.

    Also back in 2011, a letter mentioned the problem with the normal range:
    and the authors in reply didn't mention anything about this not being possible.

    Nor did they in the Lancet paper itself.

    (There is also a good chance the same point was brought up in the Hooper letters that Peter White replied to (I don't have time to look through them again) but Peter White's letters don't talk about different thresholds for different groups either (I would remember if he did say this)).

    In theory we could speculate that authors of papers did lots of other things that we don't know about: all we have is what was reported they said they did.
     
    Last edited: Jul 9, 2014
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  8. Tom Kindlon

    Tom Kindlon Senior Member

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    There was another Forward ME meeting on June 25, soon after the previous one, and the issue was also discussed at this:


    http://www.forward-me.org.uk/25th June 2014.htm


     
  9. WillowJ

    WillowJ Senior Member

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    That's true that we don't know whether or not this actually occurred during the study.

    I agree with the others that simply the fact that they overlap show not only that the criteria for "recovery" being used are absurd and not useful in a clinical setting (if they want to argue that there is something in debating what 'recovery' means in a theory room somewhere, have at it, but don't they should not ask me to accept a 'recovery' that is not meaningful to me, or to support a public policy based on such).

    Also the fact of overlap by itself clearly demonstrates that the methods and the review of the paper were unacceptably sloppy, and the paper should not have been published until this was rectified.

    This should have been caught by the study authors themselves and by reviewers if not. The fact that it was not corrected by anyone deserves investigation into what went wrong and how to prevent it in the future.

    Furthermore, it is unacceptable that conclusions based on this very sloppy method have been allowed to remain, and worse, to inform public policy.
     
    Last edited: Jul 9, 2014
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  10. Sean

    Sean Senior Member

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    As has been said before, it is quite clear that peer review in this area of medicine has broken down and is not fit for its intended purpose.
     
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  11. Firestormm

    Firestormm Guest

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  12. user9876

    user9876 Senior Member

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    Because White is harassing a researcher who asked for data and should be thrown out of the research collaboration.

    White chooses what comments he addresses publicly but works the system behind the scenes. So he complains about researchers privately to their institution whilst publicly stating recovery measures for PACE based on threshold that he must know are ridiculous.

    Why is there very little real ME research and why is publication so hard. Its because people like White (the psychiatrists pushing GET and CBT) block things that don't agree with his views. That's what Lipkin was reported as saying with respect to his research proposal in the states. I think Montoya had commented on how hard it was to publish around ME. Didn't Julia Newton recently have a paper rejected I wonder who the reviewers were? Yet Esther Crawley got £300,000 in research funding for what seems like a very poor proposal that doesn't even connect between work proposed and outcomes claimed.

    So why Holgate. Well he needs to look at how the research collaboration can work with such attitudes from White. My guess is that he won't challenge White's behavior or tell him that the PACE data as set out in the protocol needs to be published. The MRC also need to act but again won't. Why, I don't think its a big conspiracy but those in the system don't like to challenge others.
     
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  13. Sean

    Sean Senior Member

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    It is rapidly becoming one.

    Which is one reason why I am increasingly opposed to anonymity in peer review (at least after a paper has been accepted/rejected). There needs to be a clear trail to make sure that any prejudice, incompetence, or straight malevolence, can be spotted and dealt with, and that reviewers know that in advance.

    Reviewers, and the whole peer review system, must wear their mistakes. Because I am sick of having to do it for them, with no say in the matter.
     
  14. user9876

    user9876 Senior Member

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    When I say I don't think its a big conspiracy I mean I don't think they meet and decide to block I think its just the culture within certain groups to do this. I agree that peer review shouldn't be anonymous and I think the research proposal process should also be open.
     
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  15. anciendaze

    anciendaze Senior Member

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    I have a modest proposal concerning the tiny part of the study based on objective data. Since around 30% of all patients in every group declined to take the 6-minute walk test either before or after therapy lets simply ask that data from those patients be removed. This would remove about 200 patients from the study, and the statistical results would look a whole lot less impressive. The alternative to this suggestion would be simply to remove any claim that authors' opinions are supported by objective data.
     
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  16. taniaaust1

    taniaaust1

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    I dont think I could even trust the data when it is finally forced to be made public as White and his co buddies have had a lot of time to go and alter it to try to hide their fraud.

    No one can say they didnt go about purposely trying to deceive the public, these guys know they've done wrong.. what extent will they go to to hide it?
     
    Last edited: Jul 10, 2014
  17. Sean

    Sean Senior Member

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    anciendaze

    :thumbsup:
     
  18. Sean

    Sean Senior Member

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    Be interesting to see if it was the same patients refusing before and after, or different ones. And why.
     
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  19. anciendaze

    anciendaze Senior Member

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    That goes into territory I don't expect to ever be open to investigation. I would point out that patients who have suffered deterioration would be more likely to decline an optional test requiring exertion. Apparently, the authors slipped one by on readers by implicitly assuming there were no such patients who suffered a setback in this portion of the cohort. The possibility of setbacks was one of the questions the study was supposed to answer. I think this illustrates the authors' technique for answering scientific questions.

    The central absurdity I'm trying to expose is counting patients who were not tested both before and after therapy as if they were subject to objective tests. Caution: removing this tiny fig leaf of objectivity could expose something rather ugly.
     
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