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.

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7 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.

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    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.

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      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.

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  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.

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    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.

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