Tribunal Orders Release of Withheld Data from Controversial £5 Million Chronic Fatigue Syndrome Study by QMUL

QMUL claims of activist behaviour also found to be “grossly exaggerated”.

Action For M.E. - A tribunal has ruled that data from a treatment trial into Chronic Fatigue Syndrome (CFS) must be released, rejecting an appeal from QMULThursday, 18th August 2016, London, UK – A tribunal has ruled that data from a treatment trial into Chronic Fatigue Syndrome (CFS) must be released, rejecting an appeal from Queen Mary University of London (QMUL).

PACE was a £5 million, publicly-funded clinical trial of exercise and cognitive behavioural therapy for CFS. It has been highly influential in determining treatment in the UK and abroad, but has been controversial. Academics and patients have both voiced concerns over “misleading” claims. Dr Richard Smith, former editor of the British Medical Journal, said in December 2015 of QMUL’s failure to release the data, “…the inevitable conclusion is that they have something to hide”.

QMUL spent over £200,000 on legal fees in this case, to appeal the Information Commissioner’s decision that they should release anonymised data from the trial. The request for data was made under the Freedom of Information Act by Mr Alem Matthees, to allow analysis of the data according to the study’s original published protocol.

QMUL made several arguments why the data should not be released, their main claims being that the data was personally identifiable information, and was not sufficiently anonymised. However, the tribunal rejected these arguments, noting that QMUL had already shared the data with a small selection of other scientists, stating, “In our view, they are tacitly acknowledging that anonymization is effective, or else they would be in breach of the consent agreement and the DPA principles.”

The tribunal was satisfied that the data “…has been anonymised to the extent that the risk of identification is remote.” The tribunal also noted the “strong public interest in releasing the data given the continued academic interest” and “the seeming reluctance for Queen Mary University to engage with other academics they thought were seeking to challenge their findings.”

In his correspondence with the court, Mr Matthees expressed “concerns that QMUL are restricting the registered researchers to whom they disclose the data upon request.” The tribunal said, “The evidence before us is not clear but if QMUL are cherry-picking who analyses their data from within the recognised scientific research sphere to only sympathetic researchers, there could be legitimate concerns that they wish to suppress criticism and proper scrutiny of their trial.”

In its submissions QMUL made a number of accusations of harassment from patients, while QMUL’s expert witness characterized PACE trial critics as “young men, borderline sociopathic or psychopathic”, remarks the Information Commissioner dismissed as “wild speculations”.

When pushed to provide evidence of these threats and harassment under cross examination, witnesses speaking for QMUL were unable to do so, and ultimately conceded that “no threats have been made either to researchers or participants.”

The tribunal found QMUL”s assessment of activist behaviour to be, “grossly exaggerated” stating that “the only actual evidence was that an individual at a seminar had heckled Professor Chalder.” [Professor Chalder is a leading researcher in the PACE trial and a key witness for QMUL.]

 

Source: #MEAction