A Response to the blog by Puebla and Heber of PLOS ONE

PLOS ONE has issued an expression of concern regarding a cost-effectiveness analysis on results from the PACE trial. The concern is because the authors will not provide data requested by Professor Coyne. The PLOS ONE regulations in force at the time stated:

‘Publication is conditional upon the agreement of the authors to make freely available any materials and information described in their publication that may be reasonably requested by others for the purpose of academic, non-commercial research.’

Queen Margaret University London (QMUL) is the responsible authority for the PACE trial, but for the purposes of this particular paper the role is played jointly by Kings College London (KCL) and QMUL. KCL and QMUL continue to refuse to release the data.

Iratxe Puebla, Managing Editor for PLOS ONE, and Joerg Heger, Editor-in-Chief of PLOS ONE, have written a blog giving their view of the arguments involved and an insight into some of their thinking in issuing the expression of concern.

One line gives cause for concern and I have written a response. I did post this response as a comment underneath their blog, but after more than 24 hours the comment still remains ‘awaiting moderation’. I have therefore decided to publish it here.

It is worth reading also the dismissive, arrogant, ignorant letter to Professor Coyne from KCL refusing his request for the data.
https://dl.dropboxusercontent.com/u/23608059/PACE%20F325-15%20-%20Prof.%20James%20Coyne%20-%20Response-2.pdf

 

(Note: the comment has now been approved on the PLOS ONE site.)

 

My response:

“Interestingly, the ruling of the FOI Tribunal also indicated that the vote did not reflect a consensus among all committee members.”
This line is misleading and reveals either ignorance or misunderstanding of the decision in Matthees.

The Information Tribunal (IT) is not a committee. It is part of the courts system of England and Wales.

First, the IT’s decisions may be appealed to a higher court. As QMUL chose not to exercise this right but to opt instead to accept the decision, then clearly it considered there were no grounds for appeal. The decision stands in its entirety and applies without condition or caveat.

Second, court decisions are not applied differently according to how those decisions are reached: they are full and final. Majority verdicts have no less standing. We are all familiar with the work of the UK & US Supreme Courts. Roe v Wade is not mitigated because it was a majority decision. May could not fudge the need for parliamentary approval of Brexit because the UKSC was not unanimous.

Third and above all, it is misleading to suggest there was a lack of consensus in the Tribunal.
The court had two decisions to make:
First, could and should trial data be released and if so what test should apply to determine whether particular data should be made public? Second, when that test is applied to this particular set of data, do they meet that test?

The unanimous decision on the first question was very clear: there is no legal or ethical consideration which prevents release; release is permitted by the consent forms; there is a strong public interest in the release; making data available advances legitimate scientific debate; and the data should be released.

The test set by this unanimous decision was simple: whether data can be anonymized. Furthermore, again unanimously, the Tribunal stated that the test for anonymization is not absolute. It is whether the risk of identification is reasonably likely, not whether it is remote, and whether patients can be identified without prior knowledge, specialist knowledge or equipment, or resort to criminality.

It was on applying this test to the data requested, on whether they could be properly anonymized, that the IT reached a majority decision.

On the principles, on how these decisions should be made, on the test which should be applied and on the nature of that test, the court was unanimous.

It should also be noted that to share data which have not been anonymized would be in breach of the Data Protection Act. QMUL has shared these data with other researchers. QMUL should either report itself to the Information Commissioner’s Office or accept that the data can be anonymized. In which case, the unanimous decision of the IT is very clear: the data should be shared.

PLOS ONE should apply the IT decision and its own regulations and demand the data be shared or the paper retracted.

Advertisements

10 thoughts on “A Response to the blog by Puebla and Heber of PLOS ONE

  1. While I appreciate the comment, I am unsure if it is correct as a matter of law.
    My understanding of the process as it applies in social security is: (I have gone through the UT process, it’s painful)

    First tier tribunal makes a decision which is only relevant to this case.
    Tribunal decides against one party.
    That party appeals to the upper tribunal on one of several limited grounds of appeal. (wednesday unreasonability, errors of law, …)
    Upper tribunal decides matter.

    It is only at the point the upper tribunal decides something does it change the approach that should be taken to the law.
    The lack of an appeal from the first tier tribunal does not make the FTTs decision binding on other FTTs or data handlers. They may choose to act like it was, on the basis of prudence.

    Like

    1. That does not change the fact that the Information Tribunal is not a committee and that its decision on the principles of the case was unanimous. It is QMUL and KCL who treat the request for data as an FOIA request. The only request re PACE data to go to the IT was decided in this way. It was not appealed. It is PLOS ONE who referred to that decision. If the Matthees decision is going to be applied to other requests for data, then it should be applied accurately.

      Like

      1. The point is that there is no ‘Matthees decision’ that is binding outside of this case. First tier tribunals do not set caselaw. Prudent people may of course choose to consider if they want to try running an argument again which has failed once, but legally there is no precedent, and the law stands just as it did before this case.

        Like

  2. That doesn’t alter the facts: The IT is not a committee but a part of the courts system of England and Wales. QMUL did not appeal. Majority decisions carry no less weight than unanimous ones, but in any case the decision on the principles, which test should apply and how was unanimous. If the decision is being used as a reference and guide, as it clearly is, then it should be used accurately.

    Liked by 1 person

    1. Correct about majority decisions. For instance, in the US the Supreme Court decisions of 5-4 become the law of the land. And if lower court decisions are not appealed, they become law in whatever jurisdiction the decision was made no matter the split. Other jurisdictions would see the lower court decision and may follow the principle set unless they want to try to bring a like case to their jurisdiction’s court (which may look at the other court decision) and if not in their favor try higher courts and then the Supreme Court.

      This was a legal case that was decided by a majority and then honored. I believe QMUL did not appeal for three reasons: 1) They would have lost. 2) They did not want to bring more attention to the case because you have a sick person fighting for a simple FOIA AND they know the data shows the trial was flawed. 3) No way did they want this to go to a higher court, lose, and set a law of the land precedent.

      Like

  3. The following comment was just posted as http://blogs.plos.org/everyone/2017/05/02/data-sharing-in-clinical-research/#comment-425008

    It is highly likely that Iratxe Puebla will not tolerate that this comment will be approved and that readers of http://blogs.plos.org/everyone/2017/05/02/data-sharing-in-clinical-research/ will thus not be able to read my views about this issue. I have therefore decided to deposit a copy of this comment over here.

    “This posting of 2 May 2017 by IP and JH is a nice example of ‘partial behaviour’. Author IP has started already a while ago with badmouthing in public about me and thus will not tolerate that this comment will be published. That’s of course no problem at all for me.

    This badmouthing of author IP about me, in stead of working together with me to ensure that two fraudulent papers on the breeding biology of the Basra Reed Warbler get retracted, underlines thus my view that this posting of IP (and JH) is a nice example of ‘partial behaviour’.

    I reiterate that author IP will go out of her league to have a scientific dialogue with me about the ‘Final investigation on serious allegations of fabricated and/or falsified data in Al-Sheikhly et al. (2013, 2015) – 1 July 2016’, a report which is since 1 July 2016 in the possession of author IP. A copy of this report has recently also been deposited at Academia and at ResearchGate. I reiterate that IP has in stead started with badmouthing about me and that it is thus also not a big surprize that author IP shows partial behaviour when it comes to the release of the raw research data of this PLOS paper, and that author IP thus ignores / rebuts / refutes the view of the Academic Editor of this paper (of which I have communicated and who confirmed to me this view of him).

    Once again, no one will be able to read this comment as author IP will not tolerate that this comment will be published.

    Disclaimer: I am in the possession of letters from laywers from IP with unsubstantiated statements / claims about my acting in regard to my efforts to get retracted both fraudulent articles on the breeding biology of the Basra Reed Warbler. My views about author IP are therefore heavily biased. I reiterate that IP will not tolerate that this comment will be published and that therefore readers will also not be able to read this disclaimer.

    I am hereby inviting IP to rebut / refute over here my view that this posting is a nice example of ‘partial behaviour’.”

    Like

  4. Update. The words ‘to prevent’ need to be added to the quote: “I reiterate that author IP will go out of her league to bhave a scientific dialogue with me about the ‘Final investigation on serious allegations of fabricated and/or falsified data in Al-Sheikhly et al. (2013, 2015) – 1 July 2016’, a report which is since 1 July 2016 in the possession of author IP.”

    So this quote must be read as: “I reiterate that author IP will go out of her league to prevent to have a scientific dialogue with me about the ‘Final investigation on serious allegations of fabricated and/or falsified data in Al-Sheikhly et al. (2013, 2015) – 1 July 2016’, a report which is since 1 July 2016 in the possession of author IP.”

    A copy of this report has been deposited at https://www.academia.edu/33827046 (and also at https://www.researchgate.net/publication/318340512 ).

    Like

  5. Iratxe Puebla and Joerg Heber state at http://blogs.plos.org/everyone/2017/05/02/data-sharing-in-clinical-research/ “We sought advice from two editorial board members who recommended pursuing access to the dataset and advised that individual-level patient data for Tables 1-5 were necessary to allow replication of the analyses.”

    The Academic Editor of http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0040808 is Pieter van Baal of Erasmus University https://www.eur.nl/people/pieter-van-baal/

    I am in the possession of an e-mail from Dr. van Baal dated 25 January 2016 in which Dr. van Baal confirms that he is one of these two ‘editorial board members’. The Academic Editor Dr. van Baal thus holds the opinion that professor James Coyne, and others, must indeed get access to the raw research data of this PLOS ONE paper. Below the verbatim response from Dr. van Baal [in Dutch] which I received on 25 January 2016, and which was a response on a request from me and dated 22 January 2016.

    “From: Pieter van Baal; To: Klaas van Dijk; Sent: Monday, January 25, 2016 10:50 AM; Subject: RE: Verzoek om een update over de stand van zaken over het verstrekken van alle ruwe data van pone.0040808

    Beste Klaas, Ik heb het verzoek van PloS One gekregen om nog eens goed naar de studie te kijken en mijn advies uit te brengen. Ik heb de studie opnieuw gelezen en ben tot de conclusie gekomen dat in mijn ogen de kosteneffectiviteitsstudie correct is uitgevoerd, maar dat als de trial niet correct is uitgevoerd alle resultaten (inclusief natuurlijk de kosteneffectiviteit) in twijfel moeten worden getrokken. Mijn advies aan PLos kwam er op neer dat het me verstandig lijkt om de data die nodig zijn om de kosteneffectiviteitsstudie te repliceren openbaar te maken (vanwege alle commotie maar ook omdat de studie publiek is gefinancierd). Ik ben wel bang dat het openbaar maken van de data geen helderheid kan geven over de vraag of de trial correct is uitgevoerd. PLoS is zich aan het beraden over volgende stappen. Vriendelijke groet, Pieter van Baal”

    From: Klaas van Dijk; Sent: 22 January 2016 8:04 PM; To: Pieter van Baal; Subject: Verzoek om een update over de stand van zaken over het verstrekken van alle ruwe data van pone.0040808 (…);”

    I thus fail to understand why Iratxe Puebla [Joerg Heber was at that time not yet Editor-in-Chief of PLOS ONE and was at that time also not yet employed by publisher PLOS] has not immediately told in those days, so in January 2016, the authors of the PLOS ONE paper to ensure that James Coyne and others get access to the full set of requested raw research data, and within a fixed period of time, for example two weeks from the date of this formal request from publisher PLOS, and that the authors automatically agree with a retraction of their paper in case they fail to provide James Coyne and others full and unlimited access to the requested set of raw research data within the set period of time (so for example two weeks time).

    Like

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s