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