A tribunal has recently ruled that anonymous data from the controversial PACE trial must be released, rejecting an appeal from Queen Mary University of London (QMUL).
The data in question has been discussed on this blog before and you can read here to understand exactly what data we are talking about. It includes no personal identifiers.
The release of this data would allow for a reanalysis of the primary outcome measures according to the thresholds pre-specified in the researcher’s own published protocol. The recovery analysis in their published papers diverged from their own protocol, and included them lowering the recovery thresholds – this had the effect that more patients appeared to “recover” than if they had stuck to the planned thresholds for recovery. It’s possible that against the original recovery thresholds PACE may fail to demonstrate any significant recovery in patients – which would make the trial a failure.
QMUL can potentially appeal the tribunal’s decision and try again to block the release of the data that would allow this analysis. QMUL have already spent over £200,000 on legal fees on this tribunal case alone, which seems extraordinary considering they are a public institution. Following the tribunal’s decision they released this statement on their website: Disclosure of PACE trial data under the Freedom of Information Act
Prior to the tribunal, QMUL released a similar statement in which they said they were “seeking…the advice of patients”: Release of individual patient data from the PACE trial which led me to write to ME/CFS charities asking them to speak on behalf of patients. I asked patients to do the same, and you did! The effort was a success with 29 charities across the globe writing to QMUL on the request of patients to call on them to release the data and drop their appeal. This was submitted to the tribunal as evidence of the public interest in the data being released. Regarding the clear public interest in the release of the data, the tribunal stated:
“There can be no doubt about the Public Interest in the subject matter which is evident throughout the course of this appeal, and beyond, and we are grateful for the assistance that has been given to us in this regard.”
It was surprising that QMUL chose to ignore such strong public interest in the release of the data, which included thousands of patients, patient organizations, and academics. It appears they were not sincere in their wish to take account of the advice of patients, after all and I note that in their most recent statement, this time they do not invite the views of patients. But their most recent statement does say this (my emphasis added):
“We are studying the decision carefully and considering our response, taking into account the interests of trial participants and the research community.”
Perhaps QMUL will be consulting with participants then. QMUL surely do not mean to decide what is in the interests of participants without consulting them? To not consult participants would seem quite remarkable to me, but for all I know QMUL have been keeping participants informed and are seeking their views following the tribunal decision.
Given the Judge has ruled that they “…are satisfied that the risk of identification has been anonymised to the extent that the risk of identification is remote”, and that there is “…a strong public interest in releasing the data…” it is hard to see how QMUL could claim the interests of participants could be furthered by another appeal.
It must never be forgotten that trial participants are also patients, and members of the public too. However, this has not stopped QMUL in its various submissions from making a number of accusations of harassment from patients. In a separate FOI case, under a section they entitled “Harassment,” QMUL have pointed to the 12,000 strong petition calling for PACE claims to be retracted – most of those signatures are patients and some may be from patient participants in the PACE trial.
QMUL has accused patients in their “further skeleton” submission to the tribunal, where they claim “’highly critical’ and ‘vitriolic’ patient/activist groups” have tried to discredit the research.
One such activist group, according to QMUL, is the patient forum Phoenix Rising. Professor Jonathan Edwards, a member of the Phoenix Rising Board of Directors, appears to have been displeased with this accusation, as evidenced by his submission to the tribunal, referred to in the tribunal’s decision:
“Professor Edwards takes issue with the assertions that Phoenix Rising is allowing inappropriate behaviour, and further takes issue with the term ‘activist’ being used for its audience. He distinguishes highly motivated data requesters from those acting inappropriately or unreasonably. He accepts that certain individuals have expressed their frustrations with the misinterpretation of the PACE trial on the website in abusive terms, but this pales in comparison with four years of “intelligent and measured critique” provided by the other patients. Rather, the campaign to discredit or hijack the issue has come from the PACE authors and their colleagues in a series of attacks in review articles in the national press, online and in public presentations.”
The tribunal decision notice shows that one of QMUL’s arguments against disclosure of the anonymous PACE data was that “It would cause unwarranted distress to participants and open them to criticism or harassment.”
One document submitted by Alem Matthees as part of the evidence to the tribunal was a document collating the publicly available comments from PACE trial participants who had voluntarily come forward to express their views in public. A copy can be found here. It was submitted to dispute the claims of QMUL that patient participants were in danger of being harassed, and shows that in all cases where patient participants have come forward they have not been harassed, but rather have been praised, thanked and supported. This is no surprise, as we are all patients and we all just want to get better.
The Judge, considering this, and other evidence, found QMUL’s assessment of activist behaviour to be “grossly exaggerated” and QMUL were forced to admit at the hearing that “no threats have been made either to researchers or participants.”
But understandably, patients – including patient who are participants in the PACE trial – may feel rather upset with QMUL about their negative stereotyping of patients.
The tribunal decision includes a sentence about the responsibility of QMUL to participants when it comes to information about the anonymous data, the Information Commissioner pointing out that ” It would be up to QMUL to explain to participants that their data has been anonymised so that they could not be identified from it so as to allay fears that they themselves [QMUL] seem to be attempting to stoke up.”
Again, this makes you wonder what QMUL have been telling patient participants, if anything.