New Atmosphere, New Vision: Gibson and Whittemore Kick Off Invest in ME Conference 2016
Mark Berry reports on Dr. Gibson's introduction and Dr. Whittemore's keynote speech, at the 11th Invest in ME International ME Conference in London.
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PACE Trial and research fraud

Discussion in 'General ME/CFS Discussion' started by Yogi, Sep 16, 2016.

  1. Yogi

    Yogi Senior Member

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    There has been alot of discussion here about research fraud and PACE trial.

    Good place to have a discussion of this.

    @Large Donner er @alex3619



    Here is a good article by two lawyers which deals with this issue of research misconduct.

    DBS Attorney Cal Stein Collaborates On Article About Scientific Research Misconduct
    By Callan Stein


    http://dbslawfirm.com/news/dbs-atto...-article-about-scientific-research-misconduct
     
    Last edited: Sep 16, 2016
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  2. BurnA

    BurnA Senior Member

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    I like where this thread is going, and I like it even more because someone called Lexis Nexis got a mention.
     
  3. flybro

    flybro Senior Member

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    pluto
  4. TiredSam

    TiredSam The wise nematode hibernates

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  5. flybro

    flybro Senior Member

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    hoping yr doing it sam here's the twitter link i got from
     
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  6. TiredSam

    TiredSam The wise nematode hibernates

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    done, thanks.

    http://forums.phoenixrising.me/inde...ring—why-editors-may-have-got-it-wrong.46844/
     
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  7. alex3619

    alex3619 Senior Member

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    On legal issues its important to keep in mind that we are talking about UK law, and not even EU law if the Brexit result comes through.
     
  8. alex3619

    alex3619 Senior Member

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    I have not finished that Callan article yet, but its amusing that one of the organizations that might sue the PACE authors, if reputational damage occurs, is QMUL. Indeed, so may The Lancet.
     
  9. Large Donner

    Large Donner Senior Member

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    Still trying to take in the article as its quite long but its strange that there seems to be no category of falsifying conclusions or efficacy whilst withholding data. Mainly it talks about falsifying data so far as I have read.

    Its almost as if science as a whole hasn't worked out that's its nonsensical that if you print your definitions you can make just about any claim you like in a conclusion even if your terms bare no resemblance in real terms to what they mean in everyday parlance.

    I think most of us here had established that though.

    Changing protocols halfway through a trial to attempt to derive a different outcome though may be a different matter and just saying "we got permission to do it" should not be the end of the investigation. It should be the beginning.

    Can we just imagine this excuse being used during the Volkswagen emissions scandal?

    Lets face it the improvers reanalysis shows no statistically significant differences between the treatments and yet CBT and GET has been lauded as safe effective and even a recovery instrument.

    I don't think they can just say "we got outside permission to change the definitions of recovery/improvers etc".

    Its pretty much on record now, and came out during the FOI hearing, that the PACE team have a closed nit circuit of people they consider independent when they want to say its so and not independent when it suits them. I am talking about the Cochrance "independent review" which seems to have been written by the 3 PACE investigators who are now admitted to have sat on the review panel. If anyone else was involved then they need to answer for their actions too or just tell us exactly how the meetings where held.

    If they are going to try to pass the buck all that says to me is that those who take the baton should be in the dock alongside the PACE investigators being questioned. They cant just say, "ah its fine we are the overlords we gave them permission to do it".

    I can just see Trudy Chalder attempting to call herself and two other PACE investigators as independent witnesses in court in an attempt to satisfy a judge or a jury that they had other scientists oversee their procedures and give them the all clear.

    Who exactly are the people who permitted them to change from the protocol measures? Why id they "allow" this?

    They would have to be equally as inept as the PACE investigators themselves or equally and jointly devious.

    The Lancet really has no get out but I can see QMUL taking a position wherby they claim to have been duped in order to save their own reputation.

    Maybe QMUL could wake up and smell the coffee and sue Peter White and the Lancet, now that would be a tangled web.
     
    Last edited: Sep 16, 2016
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  10. Sean

    Sean Senior Member

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    It's even worse than that.

    The just published improvers reanalysis (done according to the more conservative original trial protocol) was on the 52 week data, that had previously showed some 'benefit' using the more lax post-hoc modified version of the protocol.

    The 2.5 year long-term follow-up data was also analysed using the modified version (with results published in late 2015), and it showed a null result (no benefit).

    It seems unlikely, to put it mildly, that a reanalysis of the long-term follow-up data using the more conservative original protocol would deliver a better result. If anything it will be null by a greater margin.

    Add in the almost complete null result on objective measures, that PACE only studied mild-moderately affected patients, and a range of other methodological issues (with selection criteria, bias, etc) that are only likely to further weaken the results, and for all practical purposes PACE has delivered a null result for CBT & GET.
     
    Last edited: Sep 16, 2016
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  11. alex3619

    alex3619 Senior Member

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    Its nonsensical but it works. It appears to be their modus operandi. They rely on researchers/doctors/patients not digging to find how they define terms, and when used in public relations contexts they never ever mention the highly modified definitions. This may constitute misleading claims.
     
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  12. alex3619

    alex3619 Senior Member

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    This thread should possibly be made a private thread, especially if the discussion continues to an advanced phase.
     
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  13. Glycon

    Glycon World's Most Dangerous Hand Puppet

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    I don't know... Never underestimate the affective power of public humiliation... :cool:
     
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  14. alex3619

    alex3619 Senior Member

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    Except there might be legal implications of things said here.
     
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  15. anciendaze

    anciendaze Senior Member

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    There is something here which prosecutors in criminal cases call "a pattern of behavior demonstrating intent". Objective measures were made secondary from the word go. When there were some kind of problems with the actimeters, they were simply dropped. When data from the "step test" failed to confirm their expectations release was delayed until the long-term follow-up, allowing years of positive spin.

    When data from the 6-minute walk test grouped "improved" patients with patients with heart failure, the authors themselves said the test was incorrectly implemented. (Curiously, they were not talking about the decision to allow 1/3 of the patients to decline the test if they didn't feel like walking. Allowing those who feel worse after therapy to opt out is an obvious way to get a spurious boost in data from anything that increases variance.)

    This pattern of behavior shows they only wanted the word "objective" for publicity, not the reality of objective measures they could not manipulate. I could say more about the word "controlled".
     
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  16. flybro

    flybro Senior Member

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    Can anyone remem who it was on PRforums that did a really thorough review pf the PACE cohort, I'm sure that the chances of having anyone with ME, making it into the final cohort were negligible. Must nearly 5-6 yrs ago?
     

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