Release the PACE trial data: My submission to the UK Tribunal

 

ben franklinThe UK Tribunal has denied the appeal of Queen Mary University London on behalf of the investigators of the PACE chronic fatigue syndrome trial and ordered the release of the trial data. This landmark decision is still subject to further appeal.

You can get further details of the decision in my recent blog posts here and here.

I was not a party to the appeal. My request for the PACE trial data was for what had been promised in the submission of a manuscript and publication as an article in PLOS One. Despite its subsequent portrayal by the PACE investigators, my request was not made under the Freedom of Information Act.

I was, however, approached for advice and asked to co-sign of a draft joint statement of support. I responded on  letterhead but on the joint statement ended up actually getting submitted.

Nonetheless,  Trudie Chalder cited in testimony before the Tribunal my blogging activity and social media as an example of the reputational threat posed to the PACE investigators if they were to release their data for re-analysis. The Information Commissioner countered that I represented the quality of academics seeking independent analysis of the PACE data. The Tribunal accepted this argument. When it becomes available, I will post this testimony.

My letter of support

penn seal

Hospital of The University of Pennsylvania

March 25, 2016

JOINT LETTER TO THE FIRST-TIER TRIBUNAL

To the members of the First-tier Tribunal (Information Rights) who are handling case EA/2015/0269:

I am writing in support of the respondents, the Information Commissioner and Mr Alem Matthees.

Researchers, academics, scientists, journalists, patients, advocates, and others have expressed numerous reasonable concerns over how the PACE trial was conducted, analyzed, and reported. Over 12,000 individuals have signed a petition calling for an independent review of the PACE trial and for the release of anonymised individual patient data from the trial.

I believe these concerns warrant the disclosure of the requested data, to enable re-analysis of the trial results in a manner which can be easily confirmed and debated by others in the spirit of open science. In accordance with the Information Commissioner’s decision, I do not believe the requested data poses a significant risk of identification to trial participants. The public interest in disclosure also outweighs the interests of QMUL.

The outcome of this case will have significant consequences for the patient community and the wider research community.  Disclosure will help greatly to address important areas of scientific debate, resolve the controversy over the trial results, alleviate the distress of the patient community, and restore public trust in UK research. Non-disclosure would simply prolong the controversy and could cause further damage to the reputation of research in the UK, and to the “open science” movement in general. I also fear that non-disclosure will set a negative precedent.

I respectfully ask the Tribunal to consider the concerns I describe above, and reject the appeal from the appellant, Queen Mary University of London (QMUL), and to uphold the previous decision made by the Information Commissioner on 27 October 2015. Alternatively, I also respectfully call upon QMUL to withdraw their appeal.

Thank you for your consideration.

Sincerely,

James C. Coyne, Ph.D.

Professor Emeritus of Psychology in Psychiatry