A tribunal in the UK has rejected an appeal by Queen Mary University of London, who sought to reverse a previous order that they release data from a controversial 2011 paper in The Lancet about chronic fatigue syndrome (CFS).
The decision is one in a long series of judgments about the so-called PACE trial, which reported that two treatments — known as cognitive behavioral therapy and graded exercise therapy — helped alleviate the symptoms of the condition. But ever since The Lancet article and follow-up papers have been published, patients and critics have questioned the conclusions and clamored to see the raw data.
The main criticisms: The findings may prompt some to believe chronic fatigue is a mental, not a physical, disorder, and the PACE program could actually be harmful to patients by encouraging too much exercise. These criticisms were recently bolstered by a re-analysis of the evidence by the Agency for Healthcare Research and Quality, which downgraded its original conclusions about the effectiveness of cognitive behavioral therapy and graded exercise therapy.
In March 2014, Alem Matthees petitioned Queen Mary University of London (QMUL) — home of some of the authors of the PACE trial — to release the anonymized patient data behind The Lancet paper, under the UK’s Freedom of Information Act. QMUL refused, citing concerns doing so would “prejudice its research.”
Matthees appealed to the Information Commissioner, which ruled in October, 2015, that QMUL had to hand over the data. The university appealed that decision to the First-Tier Tribunal, which ruled earlier this month that it would uphold the Commissioner’s decision.
QMUL’s arguments for why it shouldn’t release the data included that they were “sensitive patient data” that could, with some effort, unmask patients’ identities. Furthermore, as the Commissioner’s report notes, QMUL argued:
QMUL has no permission from participants to publish data, and to require disclosure would damage trust and jeopardise future studies…
The institution also argued:
Publicity surrounding disclosure would cause anxiety to participants, particularly when one considers the potential hostility that could be shown to them by certain groups.
Two participants had withdrawn their consent following the disclosure of some 600 pages of material including details of around 50 serious adverse events and reactions recorded during the trial. This caused a delay of four months in the project and increased costs.
The Commissioner, however, ruled that the data had been stripped enough of identifiers, and it was unlikely that disclosing the data would cause a significant drop in patient participation, nor hurt the university’s future reputation or funding.
QMUL appealed this ruling, citing many of the same arguments (you can read them in detail in the report.) Matthees, in turn, cited a petition with 12,000 signatures to release the data, noting “the public interest significantly outweighs the overstated risks.”
Ultimately, the First-Tier Tribunal upheld the Commissioner’s rulings. On the “key issue” — whether patients could be identified by releasing the information — the Tribunal was split, with the majority accepting the Commissioner’s opinion that identification was “an extremely remote possibility.”
Valerie Eliot Smith, a UK lawyer who has been living with CFS (also known as myalgic encephalomyelitis), has been closely following the case. She explained that this is one of many requests for the PACE data under FOIA since The Lancet paper was published in 2011. What made this request “groundbreaking,” she added, is that it was the first to make its way up the appeal process, including a three-day hearing with witnesses.
She told us:
Many people within the international ME community have been attempting to make sense of the seemingly bizarre claims made by the authors of the PACE Trial since its 2011 publication in The Lancet. This judgment represents a defining moment for the community and for the Trial itself, whatever the final outcome of any further appeal.
This isn’t the only PACE paper for which the raw data have been requested — recently, James Coyne at University Medical Center Groningen in the Netherlands asked for the data from a follow-up to The Lancet paper, published in 2012 in PLOS ONE. Kings College London (which co-owns the rights to the data), called the request “vexatious,” and refused.
Our co-founders Ivan Oransky and Adam Marcus weighed in on the debate last year, in a STAT column titled: “To keep science honest, study data must be shared.”
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