Queen Mary University of London to appeal Information Commissioner’s decision on disclosure of PACE Trial data

UPDATE February 2016: The hearing of QMUL’s appeal is scheduled for 20-22 April 2016 in central London. Judgment is not normally given at the time of the hearing but is distributed up to three weeks later. If QMUL’s appeal does not succeed and they are ordered to release the data, they can still appeal to the next level, the Upper Tribunal. 

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Background 

I have lived with the illness myalgic encephalomyelitis (ME) for nearly 35 years. The condition is also (misleadingly) known as “Chronic Fatigue Syndrome” and is therefore often referred to as “ME/CFS” or “CFS/ME”. For more information see “About“.

I have previously written about the controversial PACE Trial (Principal Investigator: Professor Peter White of St Bartholomew’s Hospital in London) and its highly questionable effects on the treatment of patients – see PACE vs FOIA: Access Denied.

The current case

Ever since the results of this £5 million (US$8m) publicly-funded trial were published by The Lancet  in 2011, patients have been attempting to gain access to the trial data as the results were spun in a surprisingly positive light. In 2014, I made a request under the Freedom of Information Act (FOIA) to ascertain the number of requests which had been made in total. The answer wasn’t clear but the figure seemed to be in the region of 34 requests (with approximately 150 individual items within those 34 requests). However, very little data has been released so far and patient groups are still puzzled by how the results have continued to be framed in such positive terms.

Professor White has also used patients’ efforts to access trial information as a platform from which to make spurious claims of harassment by ME patients against members of the PACE team. He has also suggested that patients have been orchestrating a “campaign to discredit the trial”. Paragraphs 31 and 33 of an earlier decision notice stated that: “Professor White has made it clear that the requests are causing annoyance and frustration both to his colleagues and himself who have to deal with the requests. He has stated that he believes that the requests are clearly part of a campaign to discredit the trial and are not in the public interest…….QMUL has advised that the effect of these requests has been that the team involved in the PACE trial, and in particular the professor involved, now feel harassed and believe that the requests are vexatious in nature.”

In March 2014, the requestor in this case, Alem Matthees, sought the following trial data from Queen Mary University of London (QMUL). QMUL is the relevant public authority for the purposes of making FOIA requests about the PACE Trial:

• SF-36 physical function scores (range 0-100 points) [baseline and 52-week followup];
• CFQ fatigue Likert scores (range 0-33 points) [baseline and 52-week followup];
• CFQ fatigue bimodal scores (range 0-11 points) [baseline and 52-week followup];
• Oxford criteria CFS caseness (does participant meet criteria, yes or no) [52-week followup only];
• Participant-rated CGI scores (range 1-7) [52-week followup only];
• Doctor-rated CGI scores (range 1-7) [52-week followup only];
• 6MWT walking distances (in meters) [baseline and 52-week followup];
• The group which each participant was allocated to after randomisation (i.e. either to APT, CBT, GET, or SMC).

QMUL refused to provide the information at the initial request and the internal review stages. In December 2014, the requestor (now “the complainant”) complained to the Information Commissioner (IC) about the way the request had been handled. The IC published his decision on 27 October 2015. You can read the full 30-page decision notice here. It is a meticulously drafted decision which comprehensively dismantles QMUL’s arguments and orders disclosure of the data to the complainant.

The decision notice sets out the submissions by QMUL in some detail. In an apparent act of increasing desperation, the University argued that several of the exemptions in FOIA applied and therefore the information should be withheld. Perhaps the most egregious example was an attempt to argue that a section of the Act which was not even in force at the time of the original request could be used as a reason to withhold the data. There is a presumption in English law that legislation does not apply retrospectively, unless otherwise specified which, in this case, it was not.

There are some notable quotes from QMUL’s submissions in the decision notice; this section is a particular favourite of mine:

“The PACE trial has been subject to extreme scrutiny and opponents have been against it for several years. There has been a concerted effort by a vocal minority whose views as to the causes and treatment of CFS/ME do not comport with the PACE trial and who, it is QMUL’s belief, are trying to discredit the trial. Indeed, as noted by the editor of the Lancet, after the 2011 paper’s publication, the nature of this comprised not a ‘scientific debate’ but an “orchestrated response trying to undermine the credibility of the study from patient groups [and]… also the credibility of the investigators and that’s what I think is one of the other alarming aspects of this. This isn’t a purely scientific debate; this is going to the heart of the integrity of the scientists who conducted this study.” (Health Report, Comparison of treatments for chronic fatigue syndrome – the PACE trial (National Radio, Australian Broadcast Company April 18, 2011) interview of [Lancet editor] Richard Horton and [Professor] Michael Sharpe).

Further, in this interview Michael Sharpe, a Co-Principal Investigator of the trial, states “I think the first thing to say here is that we recruited 640 patients into this trial and there wasn’t a high rate of refusal of taking part in the trial and those patients remarkably, a vast majority of them stayed right through to the end of the trial, they accepted the treatments and they completed our outcome data. So I think it’s very important to remember that if you go out there to the clinics that most patients with chronic fatigue syndrome, all they want is the evidence for what they have to do. There is parallel to that, a very vociferous series of websites and so on, it’s not really the same world as the ordinary patient coming to the clinic. They have been quite hostile in many ways to the findings of the trial and unfortunately also to the people who’ve undertaken the trial and collaborated with the trial,” and Richard Horton comments,

“I think this is where one sees a real fracture in the patient community. One is seeing a very substantial number of patients very willing to engage in this study, desperate to get good evidence on which to base their future treatment but one sees a fairly small, but highly organised, very vocal and very damaging group of individuals who have I would say actually hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients. This community actively seeks to identify and attack those who are associated with the PACE trial.”

On reading this, one might conclude that both factual accuracy and the English language are taking a major hit here; so also is respect for a patient community which has been disproportionately neglected, abused and stigmatised for decades.

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On 26 November 2015, it became apparent that QMUL was appealing the decision of the IC. The appeal is to the First-Tier Tribunal (Information Rights). The complainant can choose whether or not to be joined as a party. It will be some months before we know the outcome of that appeal.

A final word of caution: we have been through this scenario once before, when QMUL appealed the IC’s decision in a case from 2013. QMUL’s appeal was upheld, albeit in a curiously ambivalent Tribunal judgment. Hopefully, this time there will be a better result for the international ME community.