Professor James Coyne today publicly urged the PACE trial authors and Queen Mary University of London to stop fighting the release of raw data from the study. He used his popular blog in a powerful call to those responsible for withholding the information from the £5 million, taxpayer-funded trial to “let the People’s data go”.
The controversial UK-based PACE trial studied the effect of cognitive behavioural therapy and graded exercise therapy on patients with chronic fatigue syndrome. All of the planned main outcome analyses and the thresholds used to define recovery were abandoned during the trial and replaced with new ones.
Results according to the original analyses were never published and the study authors have rejected requests under the Freedom of Information Act for both the results and for raw data that would allow independent researchers to calculate them.
Following a complaint from someone whom Coyne describes as a “citizen-scientist patient”, the Information Commissioner has now ordered the study authors to release the data or face contempt of court. This, says Coyne, is a “landmark decision” but the authors have been given 28 days to appeal.
Coyne says that “scientists need to watch closely” whether the PACE decision is overturned. He quotes bioethicist and fellow University of Pennsylvania academic Jon Merz, who said, “The litany of excuses – not reasons – offered by the researchers and Queen Mary University is a bald attempt to avoid transparency and accountability, hiding behind legal walls instead of meeting their critics on a level playing field. They should be willing to provide the data for independent analyses in pursuit of the truth.”
Coyne cites policies of the Medical Research Council who funded the trial, as well as the Wellcome Trust and the Cochrane Collaboration, favouring the open sharing of data as a public good. But, he notes, enforcement is weak, particularly in the US where requirements for data-sharing “have no teeth” and where the situation “would be worsened by reversal of [the Information Commissioner’s] decision.”
“Investigators just need to live with the possibility that their claims will be proven wrong or exaggerated,” said Coyne. “This is all the more true for claims that have substantial impact on public policy and clinical services, and ultimately, patient welfare.”
Coyne entered the long-running PACE controversy on October 29 with a blog post explaining why the latest PACE publication in Lancet Psychiatry was “uninterpretable” and had used “voodoo statistics”.
His involvement was sparked by a comment by one of the PACE investigators, Professor Michael Sharpe, reported in a much-criticised Daily Telegraph article, that patients “get locked into a pattern and their life constricts around what they can do. If you live within your limits that becomes a self-fulfilling prophesy.” Coyne said on Twitter: “I’ve had it. Sharpe quotes are offensive. Will lay waste to PACE follow up study… in blog post.”
Since then, Coyne has begun work with Professor Keith Laws to write a letter to Lancet Psychiatry about flaws in the trial. Laws is Professor of Cognitive Neuropsychology at the University of Hertfordshire, and is himself the author of two recent blog posts (here and here) criticising PACE.
Coyne will give a public talk in Edinburgh on Monday 16 November about the PACE trial, including these issues of data release. He says, “Events are still unfolding, but it appears that there are major changes going on around how we think and talk about ME/CFS and its sufferers.”
An #MEAction petition calling for the release of data from the trial and the retraction of misleading results has already gained over 9,300 signatures in two weeks, with a target of 10,000.
In August, we shared with you that we and six other ME/CFS organizations had submitted a proposal to the National Center of Health Statistics (NCHS) to fix the coding of ME/CFS in the US International Classification of Diseases (ICD-10-CM). Today, we are writing with an update on that proposal and asking that you sign the