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Coyne blog: "Recognizing when “protecting patient privacy” is mere excuse for not sharing data"

Discussion in 'General ME/CFS News' started by Sasha, Dec 22, 2015.

  1. Sasha

    Sasha Fine, thank you

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  2. TiredSam

    TiredSam The wise nematode hibernates

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    This latest post makes the PACE trial sound like the appalling scandal that it actually is. Great to see that the usual bluster and smokescreens that have served the authors so well in the past are now just serving to drop them deeper in it. The fact that "Our work has been independendtly reviewed" means "we have reviewed our own work" could have been picked up by any UK journalist who cared to look a bit deeper (or listen to patients) ages ago, but unfortunately it didn't happen.

    Finally a respected scientist who doesn't have ME is telling other scientists about it and they are interested, I suspect mainly due to the sense of unfairness that arises when you hear that someone has been breaking every rule you and your colleagues have had to abide by during your working life.

    Unfortunately for them, the PACE authors still think they're dealing with someone as unquestioning and easily persuaded by their BS as Max Pemberton. They don't seem to realise that their new audience of critical scientists will take everything they say apart and throw it back at them as they dig their own grave. They are finally getting their just desserts for impersonating scientists in the first place.
     
    Chezboo, Yogi, GreyOwl and 26 others like this.
  3. alex3619

    alex3619 Senior Member

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    I will make that my New Year wish.
     
    Webdog, Esther12, WillowTree and 10 others like this.
  4. A.B.

    A.B. Senior Member

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    PACE is an excellent example of pseudoscience. It looks like science at first glance but beneath the professional appearance is everything that is antihetical to good science.
     
  5. Cheshire

    Cheshire Senior Member

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    Like Canada Dry: it looks like science, it tastes like science, but it's not science.
     
    sarah darwins likes this.
  6. eafw

    eafw Senior Member

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    It is mind-boggling that this, and much else about the PACE fiasco, has been pretty much in plain sight for years. Worrying that people have so easily been distracted by the smoke and mirrors BPS campaign and ignored all of us who've been saying "but it's right there, look at it !"
     
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  7. eafw

    eafw Senior Member

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    I'm glad he's also drawing attention to the CMRC statement:

    “3.2.3 Members will be required to sign a declaration that they will not take part in the harassment or abuse of researchers. Neither will they take part in orchestrated campaigns against those conducting peer-reviewed research.”

    This level of contempt - from the people who are supposed to working towards an understanding of our condition - is unacceptable, and of course continues to perpetuate the "harraser" slander against us.
     
    Kati, Webdog, Dolphin and 8 others like this.
  8. worldbackwards

    worldbackwards A unique snowflake

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    One minor detail stood out (forgive me for being slow but you forget stuff sometimes): The sessions for PACE took place in 2006.

    2006.

    And we've just had the 2.5 year follow up.

    What exactly have they been doing for the last six years?
     
    moosie, TiredSam and Kati like this.
  9. alex3619

    alex3619 Senior Member

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    Good question. We can guess at answers but this is shaping up to needing an international independent review. Is this science, or is it playscience? Rhetorical question.
     
    TiredSam and worldbackwards like this.
  10. Esther12

    Esther12 Senior Member

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    The trial on-going past 2006 wasn't it. Can't remember when it ended now.
     
    TiredSam likes this.
  11. soti

    soti Senior Member

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    I wouldn't read too much into the delays. As with any project involving a lot of people, it doesn't shock me if some things are going to be placed on the back burner for years awaiting person-hours. Plenty of other things that are more shocking here.
     
  12. Esther12

    Esther12 Senior Member

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    Oh - also: another good blog. Took on a few issues briefly. A fun read. Totally taking these for granted now.
     
    Sasha likes this.
  13. Sean

    Sean Senior Member

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    There should be intense pressure on PACE to do the 5 year follow-up paper. That time period has passed so there is no excuse to delay it, and in the circumstances there is an overwhelming case to get that result out.
     
  14. TiredSam

    TiredSam The wise nematode hibernates

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    The fact that King's College offers this course shows where they stand on BPS/CBT:

    http://www.kcl.ac.uk/study/postgrad...octorate-in-clinical-psychology-dclinpsy.aspx

    "The programme is underpinned by a biopsychosocial framework and emphasises the integration of theory, research and practice in all aspects of training. The programme takes cognitive-behavioural therapy as its main therapeutic modality, and has particular strengths in family therapy, mindfulness-based interventions, neuropsychology and clinical health psychology."

    They're all in it up to their necks.
     
    Invisible Woman likes this.
  15. Daisymay

    Daisymay Senior Member

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    Margaret Williams posted this comment on the blog:


    Two points merit further consideration: (i) the matter of guaranteed confidential storage of PACE trial data and (ii) the Principal Investigators’ undeclared conflict of interest until after the consent forms were signed by participants.

    The PACE trial Protocol published in BMC Neurology on 8 March 2007 was an abridged version but, as noted by Alem Matthees, the Full Protocol (226 pages) states on page 110:

    “Your GP and any other doctors you are consulting will be told you are joining our study. And occasionally, other researchers will need to see your notes so they can audit the quality of our work. An audit might be run by one of the universities helping with our study or hospital regulatory authorities, or by one of the organisations funding our study” http://www.meactionuk.org.uk/FULL-Protocol-SEARCHABLE-version.pdf

    What Matthees did not mention was the fact that one of the organisations funding the study was the UK Department for Work and Pensions (DWP). How many participants looked at the funding bodies before signing the consent forms and realising to what they were giving their consent?

    Quite how “confidentiality” could be guaranteed if the DWP had access to the data has never been explained, especially as ME/CFS is known to be a targeted disorder for the withdrawal of state benefits, with patients being harassed by the DWP who required a 60-page form to be completed because the DWP menacingly informed such patients: “We have reason to believe that you are capable of work”.

    If the PACE trial therapists and Investigators deemed a participant “recovered” enough to resume work, then might that participant quickly discover that the DWP stopped paying benefit? The PACE Trial has been described as a “Trojan horse” for the DWP.

    Regarding the secure storage of data, the Full Protocol is unambiguous:

    “Will you keep my details confidential?”

    “Yes. All your details and all recordings will be kept strictly confidential and held in a locked filing cabinet or on a secure computer. People on our research team will only see your records if they need to for the research”.

    The DWP was not involved in research but still had participants’ signed permission to access their records/data.

    From the outset, recordings were not kept in a locked filing cabinet: some were stolen and thus lost to review (see previous post on 19th December 2015:https://jcoynester.wordpress.com/20...-to-release-the-pace-trial-data/#comment-1375 ).

    The Consent Form 1 for baseline assessment which participants were required to sign was clear:

    “3. I understand that any of my medical notes may be looked at by responsible individuals from either the trial or regulatory authorities where it is relevant to my taking part in research.

    4. I give permission for these individuals to have access to my records.

    …………

    14. I understand that information collected about me for the trial, including my personal details, a copy of this consent form and all of the questionnaires I complete for the trial, will be held securely by the local trial staff and at the PACE trial centre at Queen Mary, University of London. I give permission for this to happen”.

    The PACE PIs obtained participants’ consent on the promise of keeping trial data secure, yet they had made no provision to do any such thing.

    When the PACE Trial had been running for two years, the Participants’ newsletter (Issue 1, June 2006) reaffirmed that the trial data was safe: “The information is being entered onto a large and secure database, designed and maintained by an independent clinical trial unit at King’s College, London”. This was provided for participants even though the PIs knew that trial data had already been stolen (see previous post #comment-1375).

    In relation to the PIs’ undeclared conflict of interest, one of the pre-trial assessments was at Baseline Visit 1; this set out to collect personal data that seems to have little bearing on a clinical trial but could be of value to the DWP and the permanent health insurance industry because the collected data included not only the customary demographic details, date of birth, age, sex, ethnicity, marital or partner status, years of education, occupation (the latter would obviously afford information about a participant’s earnings) but also very detailed questions about participants’ permanent health insurance payments, for example, questions on page 172 ff of the Full Protocol included the following:

    “Do you currently receive income protection benefit (income protection or total and permanent disability)?”

    “ If yes, how much annually do you receive? £”

    “If the participant chooses not to give an answer, please use the prompt card to show income brackets, and record the letter [an alphabetical letter designating an income bracket] that corresponds to the participant’s income”.

    “Do you currently receive a private medical / retirement pension?”

    “If yes, how much weekly do you receive? £
    OR
    If yes, how much monthly do you receive? £
    OR
    If yes, how much annually do you receive? £”

    “If the participant chooses not to give an answer, please use the prompt card to show income brackets, and record the (alphabetical) letter that corresponds to the participant’s income”.

    “In the past six months, have you received any one-off payments from income protection or insurance schemes as a result of your health?”

    Such specific questions have no clinical relevance but would be of interest to the Chief PI of the PACE trial in his dual role as the re-insurer Swiss Re’s Chief Medical Officer.

    As detailed by David Tuller, participants could not give fully informed consent because the PIs’ Iong-standing involvement with the permanent health insurance industry was never disclosed to them. Indeed, it appears that this significant conflict of interest was not initially disclosed even to the Trial Steering Committee: at the meeting on 22nd April 2004, all members present were asked to declare any conflict of interest. It was minuted that no financial conflicts of interest were declared and it was agreed that no-one present had any other substantial or material conflict relevant to their work on the PACE Trial. Amongst those present were Professors Peter White, Michael Sharpe and Trudie Chalder, all of whom worked for the permanent insurance industry. There was a brief mention of paid consultancy work done by the PIs in the BMC Neurology version of the Protocol, which was long after signed consent forms had been obtained.
     
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  16. Invisible Woman

    Invisible Woman Senior Member

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    Wow. Every time you think it just can't get any worse it does. I'd like to say I'm surprised but there are just no depths that these so called professionals won't sink to.
     
    sarah darwins and meandthecat like this.

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