From The BMJ news hub, 22 August 2016. Story by Ingrid Torjesen.
A tribunal has ruled that Queen Mary University of London must release data from a trial looking at treatment of chronic fatigue syndrome, which found that cognitive behavioural therapy and graded exercise therapy helped to alleviate the symptoms of the condition.(1)
The findings of the PACE (Pacing, graded Activity, and Cognitive behaviour therapy: a randomised Evaluation) trial, published in the Lancet in 2011,(2) were questioned by some academics and patients, who argued that the PACE programme could harm patients.
In March 2014 Alem Matthees, a patient in Australia, submitted a freedom of information request to Queen Mary University of London, where some of the PACE researchers were based, asking for the anonymised patient data to allow analysis of the data according to the study’s original published protocol. The university refused the request, so Matthees filed a complaint with the information commissioner for England. The commissioner ruled in October 2015 that the data had to be released, but the university appealed that decision.
The university’s main arguments for not releasing the data were that they were not sufficiently anonymised and that it did not have permission from participants to publish the data. To require disclosure would damage trust and jeopardise future studies, the university said.
The tribunal dismissed the appeal, saying that it was satisfied that the data had “been anonymised to the extent that the risk of identification is remote.” It added, “There is a strong public interest in releasing the data given the continued academic interest so long after the research was published and the seeming reluctance for Queen Mary University to engage with other academics they thought were seeking to challenge their findings.
“There is insufficient evidence to persuade us that disclosure of the disputed information would cause sufficient prejudice to QMUL’s [Queen Mary University of London’s] research programme, reputation, and funding streams.”
A spokesperson for the university said, “This has been a complex case and the tribunal’s decision is lengthy. We are studying the decision carefully and considering our response, taking into account the interests of trial participants and the research community.”
Keith Geraghty, honorary research fellow at the University of Manchester, said that he had contacted the PACE researchers to request access to the data to run an independent analysis, but his request “was first ignored, then later refused.”
He added, “I now understand that the authors shared the data with a select few academics who they picked to co-write papers, but they have failed to share the data with the broader scientific community. Selectively sharing this publicly funded data with collaborators, but refusing to share data with anyone else, is not in the best interests of patients or science, and it creates a perception that the PACE team do not want independent critical analysis of this trial.”
He added that it was “regrettable” that the UK Medical Research Council, which partly funded the £5m (€5.8m; $6.5m) study, “did not specify that the trial data be made available to other researchers.”
Jonathan Edwards, emeritus professor of connective tissue medicine at University College London, said that the tribunal had made the right decision. He noted, “The reasons given for not providing the information requested are essentially groundless. It is also clearly appreciated that critics of the PACE trial are not young sociopaths—they include senior medical scientists like myself, concerned about poor science.”
1) General Regulatory Chamber. First-tier tribunal. Appeal number EA/2015/0269. 2016. www.informationtribunal.gov.uk/DBFiles/Decision/i1854/Queen%20Mary%20University% 20of%20London%20EA-2015-0269%20(12-8-16).PDF.
2) White PD, Goldsmith KA, Johnson AL, et al. PACE trial management group. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 2011;377:823-36. doi:10.1016/S0140-6736(11)60096-2 pmid:21334061.