Update on my formal request for release of the PACE trial data

plos oneAdministrative staff at PLOS asked me to inform them if I had any difficulties obtaining the data that I had formally requested from the authors of the PLOS article. Here is my reply –

The deadline that the authors’ university has set for responding to my request has passed. The university has not responded to my further query as to when the data will be forthcoming.

The author group has a consistent history of refusing requests to provide their data to other investigators. Their PACE clinical trial that served as the basis for the publication in PLOS has become quite controversial. Critics including myself have raised considerable doubts about their basic design, their changing of the trial’s endpoints after the trial began, and their analysis and interpretation of the data. There have also been complaints that analyses in published papers and lack sufficient detail and transparency to allow independent evaluation of what was done and how the authors interpreted their results.

It is a matter of public record that the authors have denied at least 14 requests for sharing of their data, notably for data are used in articles appearing in Lancet, Psychological Medicine, and Lancet Psychiatry. In each case, the investigators have deemed requests “vexatious” and argued release of data would undermine their personal credibility and that of the study. Richard Horton, editor of The Lancet has gone on record with an estimate that the investigators have spent over 750,000 pounds in fighting requests to share their data.

In a 30 page decision on October 27, 2015, the UK’s Information Commissioner’s Office ordered Queen Mary University of London (QMUL) to release anonymized from the PACE trial data to an unnamed complainant. The PACE investigators have appealed that decision and so any release is delayed. The data set cited in that IOC order overlaps with what I am requesting,, but omits some specific data needed to redo the analyses presented in the PLOS article with appropriate sensitivity analyses.

A cross-sectional study in PLOS One found an unwillingness to share data in response to formal requests is associated with weaker evidence against the null hypothesis of no effect and a higher prevalence of apparent errors in the reporting of statistical results. It is my opinion, after carefully considering numerous publications from this trial, that the PACE investigators seek to hide what would be revealed by release of the data used in the PLOS article. But the matter should not be a one of my versus their opinion , the scientific community needs to see the data. This is particularly so when such clinical and public health policy implications are being attached to the study and the PLOS article in particular.

If the PACE investigators behave consistent with their well-established pattern, they will refuse to release to me the data used in the PLOS article. However, what is different than in past requests is that mine is for data published in a journal internationally known for its commitment to transparency and data sharing. If the PACE investigators refuse, they will be testing the commitment of PLOS to its policies and the scientific community will be watching.

I am unaware of a PLOS journal’s data sharing policy similarly having been tested by investigators refusal to make their data available. In the eventuality that I do not receive their data, I believe appropriate sanctions should be available for immediate application. Otherwise the PACE investigators are making a mockery of data sharing at PLOS as they already have done with the clearly articulated policies in the UK.

I will keep you posted.

Update on my update: When I awoke this morning in Philadelphia with its five hours difference from the UK, I had received no response from King’s College, which is handling my request for the data. I then composedand sent the above email to PLOS. Apparently it crossed paths with the following email from King’s College:

Dear Professor Coyne,

Thank you for your email. Your response will be sent out next week. The 20 day time frame refers to working days and we have calculated that we should provide our response no later than 11th December.

Kind Regards

Caroline

Caroline Hill

Information Compliance Coordinator

Information Management and Compliance
Governance and Legal Services
King’s College London

Reagan

PACE investigators tear down the wall of secrecy surrounding  your data.

Note that the previous email from King’s College mentioned only 20 days, not 20 working days. And that the new email only promises a response, not the data. Stay tuned.

Note: Although I am one of thousands of academic editors for PLOS One, I have sole responsibility for my blog posts, which cannot be construed as reflecting the opinions of any institutions with which I am affiliated, including PLOS. In requesting the data for an article that appeared in PLOS, I am exercising the same rights to anyone in the world has with respect to this open access journal committed to transparency and data sharing.

 

23 thoughts on “Update on my formal request for release of the PACE trial data

  1. Thank you very much for all your work on PACE, very much appreciated. I suspect they’ll fob you off with more excuses though perhaps they’ll avoid calling you vexatious but I sincerely hope PLOS will stand by you on this, it goes way beyond PACE.

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  2. Thank you for doing this. I hope that the authors start considering patients’ right to have independent analysis done of data that affects them.

    Your request seems to have gone down some administrative channel where QMUL is dictating timeframe. Do you find that odd? Is this what you would normally expect when you request data?

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  3. Thanks for pursuing this!

    I’m so curious to see how they will respond to this request – will this request also be accused of being vexatious?

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  4. James, I was just looking through the policies of the Medical Research Council, one of the main funding sources, on the release of data. They say they require an explicit commitment to share data in any request for funding, they even invite comments on their policies, so I sent some. Basically I used the PACE trail as an example and asked what quality systems were in place and how their policies were policed, if their policies were ignored. I pointed out that unlike other publishers the fact that they spent taxpayers money much mean they are accountable in some way.

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  5. “In each case, the investigators have deemed requests “vexatious” and argued release of data would undermine their personal credibility and that of the study. Richard Horton, editor of The Lancet has gone on record with an estimate that the investigators have spent over 750,000 pounds in fighting requests to share their data.”

    That could be misleading. While some of those associated with PACE and QMUL have been presenting attempts to get information about PACE via the FOIA as a campaign of harassment, QMUL have only actually classed three specific requests as vexatious. Also, Horton’s comment about the £750k cost of PACE FOI requests came soon after the Lancet paper in 2011, so is likely to largely relate to requests for information about the trial’s design, minutes of meetings, etc. It could also relate to the cost of fulfilling requests (some information has been released) as well as the cost of fighting requests. It’s often difficult to be entirely clear about exactly what has happened as those who hold the most information about PACE do not seem committed to transparency.

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    • I certainly agree that it can be difficult to determine what is happening with the PACE trial and all the maneuvering and intrigue that is shrouded in secrecy.

      QMUL have arguably described all the PACE-related FOI requests as vexatious, and a form of harassment, in a submission to the ICO. See paragraphs 27 to 33:
      https://ico.org.uk/media/action-weve-taken/decision-notices/2015/1043579/fs_50558352.pdf

      There have been a variety of reasons given for refusal of data. I checked with my sources and asked for documentation. .As far as they are aware, only three FOI requests for PACE data have been refused specifically on the basis of being vexatious. (But there may be other requests that they are unaware of because requests can be made privately, in which case we may never know the details.)

      One such request (refused on the grounds that it was vexatious) was by Alem Matthees (26 April 2014). He asked for the timing of changes to the post-hoc recovery criteria.
      http://www.whatdotheyknow.com/request/timing_of_changes_to_pace_trial
      https://ico.org.uk/media/action-weve-taken/decision-notices/2015/1043579/fs_50558352.pdf

      Another was by Graham McPhee (29 June 2015) for the fitness test data. (For which a graph was shown, but without providing the data, in the secondary mediation analysis.)
      http://www.whatdotheyknow.com/request/fitness_data_for_pace_trial

      And the third request was made by Anna Sheridan (1 November 2015), for the six minute walking test data.
      https://www.whatdotheyknow.com/request/raw_6mwt_data_after_treatment

      One other request, by Anna Sheridan (30 May 2014), was initially refused on the grounds of it being vexatious, but after an internal review they changed their reason for refusing the request to it being too expensive to provide the data.
      https://www.whatdotheyknow.com/request/raw_data_for_6mwt

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      • W.R.T. ‘vexatious’ FOIA requests, as the comment above indicates, White et al. now consider all requests to be frustrating and annoying (i.e. vexatious), but the 3 requests listed above may be the only ones formally rejected as such under the S.14(1) exemption. For example, in October 2015 White et al. stated that they had only considered two requests ‘vexatious’ ( http://www.virology.ws/2015/10/30/pace-trial-investigators-respond-to-david-tuller ). The new request by Anna Sheridan was submitted after that date. It is not vexatious to ask about trial results and trial methodology!

        A turning point for QMUL formally rejecting requests as ‘vexatious’ may have occurred when the Information Tribunal in June 2013, after hearing QMUL’s colourful claims of a campaign of harassment, decided that a request for meeting minutes (which QMUL had rejected under a different exemption) must also be ‘vexatious’ and part of the alleged campaign ( http://www.informationtribunal.gov.uk/DBFiles/Decision/i1069/20130822%20Decision%20EA20130019.pdf ). QMUL then started rejecting requests as ‘vexatious’ in early 2014 for the first time.

        The ICO upheld QMUL’s decision for the first ‘vexatious’ request ( https://ico.org.uk/media/action-weve-taken/decision-notices/2015/1043579/fs_50558352.pdf ), but when you read the decision notice, it appears that the ICO accepted all of QMUL’s claims about feeling harassed by challenging language etc and a malicious campaign to discredit them (posting comments on the BMJ website and publishing letters to the editor were included as part of the campaign of harassment); but then the ICO refused to consider the reasons which justified the request in the first place, because they involved details about the PACE trial and therefore were outside the scope of the investigation. Such an investigation would be doomed by an imbalanced consideration of the evidence. That outcome may have made QMUL more confident in rejecting other requests as ‘vexatious’ too. Note that Ben Goldacre’s compare-trials.org project expects details on the timing of changes to pre-specified outcomes to be routinely disclosed. QMUL’s threshold for harassment is fairly low and seems to include anything they dislike or disagree with, regardless of the validity of the comments made or the importance of the questions asked.

        W.R.T. Richard Horton’s figure of £750K, here is the relevant quote: “The accusations that are being made about them is that they have behaved unethically, breached international standards of ethics, and indeed in a few examples allegations have been made to professional authorities, the General Medical Council here in the UK, about the work of these scientists, on the basis of the flimsiest and most unfair allegations. And indeed the study cost 4-million pounds to undertake but the allegations and the freedom of information requests and the legal fees that have been wrapped up over the years because of these vexatious claims has added another 750,000 pounds of taxpayers’ money to the conduct of this study.” ( http://www.abc.net.au/radionational/programs/healthreport/comparison-of-treatments-for-chronic-fatigue/2993296#transcript )

        I have been informed that as the trial cost closer to £5M not £4M, the £750K most likely includes the £702K that was spent on a trial extension ( http://www.bmj.com/content/347/bmj.f5963/rr/672398 ) which Peter White blames on “the patient community’s ‘campaign against the PACE trial'” that allegedly caused “recruitment delays that forced the investigators to seek more time and money for the study” ( http://www.virology.ws/2015/10/23/trial-by-error-iii ).

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  6. Forgive me for my ignorance but is it possible to expand on what exactly is different in terms of PLOS One’s involvement and what data is being requested that is “in the PLOS One article”?

    The PACE authors published their economic findings in PLOS One 21 September 2012 but you refer to analyses presented in a PLOS article that suggests more than the poor findings of this particular aspect of the PACE trial.

    Would it be possible to explain – in very simply layman’s terms – how exactly your request for all the raw data differs from others and its connection to PLOS One. And what type of action and/or “sanctions” are being suggested if they refuse to release the requested data.
    It would be great to fully understand the implications of this vital request?

    I have read all Tuller’s work and much more but (as someone with severe CFS) I am perhaps omitting to comprehend the nub of this article despite very much wanting to.

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  7. Thank you Dr Coyne for taking this up and pursuing the PACE trial to expose the vested interests behind the bad science.

    Thank you on behalf of all severely disabled bed-ridden “Vexatious Militants” who are too ill to even get out of bed and have been injured by GET!

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