The ME Action blog reports that the Information Commissioner’s Office (ICO) has ordered Queen Mary University of London to release anonymized PACE trial data to an unnamed complainant. Queen Mary has 28 days to appeal the decision.

The report outlines the scope of the data requested, Queen Mary’s arguments for refusing to release the data and the Commissioner’s justification for siding with the patient requesting the data be released.

Among the reasons cited by researchers for initially denying the request was the fear that the “vocal minority” of patients online would actively attempt to de-anonymize the data and reveal trial participants’ identities.

Timeline

The complainant initially requested the release of data from Queen Mary under the Freedom of Information Act on March 24, 2014 (Queen Mary has initially responded that they would not release that data since the associated costs would exceed ‎£450). On June 18, 2014, the complainant requested and internal review after which Queen Mary maintained its original position to withhold the data. In December, the complainant contacted the ICO with concerns about how the request had been handled. On October 27, 2015, the Information Commissioner sided with the complainant and order the release of the data.

Data requested

The complainant requested a version of the dataset that includes the following variables, with all potentially identifying data removed:

• 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).

Queen Mary’s reasons for denying the request

“This isn’t a purely scientific debate; this is going to the heart of the integrity of the scientists who conducted this study.”

The reasons cited for Queen Mary’s denial of the request relate to sections of the Act that allow researchers to withhold data prior to publication of the papers on which they are based. In this case, the researchers claimed that since they were continuing to publish papers, they were exempt from releasing the data. They also cited an exemption on the basis that the data contained sensitive medical information from which it was possible to identify the trial participants. They also claimed that if they released the data it might harm their ability to recruit patients for research studies in the future.

In its discussion of personal information, Queen Mary cited the problem of the “motivated intruder” who might try to identify patients based on anonymized data. Specifically they claimed that maintaining anonymity could be especially difficult given the passions of the “vocal minority,” that is, the online patient community. Queen Mary’s reasons for denying the FOI reveal a group of researchers who feel themselves besieged by what they feel is a politically motivated campaign, not the normal discourse of science:

“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.”

Michael Sharpe (PACE researcher) further explained:

“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,”

“…one sees a fairly small, but highly organised, very vocal and very damaging group of individuals who have…hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients”

Richard Horton (editor in chief of the Lancet):

“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.”

The fear was that the online patient community would take this successfully de-anonymized data and publish it online:

“…must further consider this greater risk presented for identification with this data set from the highly motivated requestor who will likely publish it on a CFS/ME group website, such as Phoenix Rising, where it will be available to all CFS/ME activists seeking to discredit the PACE trial and its researchers, as has been demonstrated, since they do not agree with the PACE trial outcomes. The risk is maximised by the fact that the CFS/ME patient community is a very small percentage of the population (e.g. estimates at less than 1%) and the PACE trial population already known to be part of that is relatively large and possibly including members of the above. The risk that additional information could be combined with the individual level data to allow identification must be considered not at all far-fetched, although QMUL need not be expected to know exactly what additional information there is presently.”

the request is merely one of a series of requests for similar access to this same medical treatment information, upheld by the ICO on several occasions, including a request by the complainant found vexatious (see FS50558352) as part of a campaign by a small group of CF/MSE activists to discredit research and researchers whose results they do not agree with.”

While some participants have volunteered to share their experiences being a part of the PACE trial on social media, there is no evidence of any concerted campaign that “actively seeks to identify and attack those who are associated with the PACE trial.”

Queen Mary also argued that release of the data might diminish trust, make it difficult to recruit patients for future trials, and hamper its ability to conduct future research in the area. And that the release of such data could have wider repercussions for the ability of researchers in general to recruit participants for clinical trials.

In his decision, the Commissioner found that QMUL failed to provide any plausible mechanism through which patients could be identified, even in the case of a “motivated intruder.” He was also not convinced that there is sufficient evidence to determine that releasing the data would result in the mass exodus of a significant number of the trial’s 640 participants nor that it would deter significant numbers of participants from volunteering to take part in future research.