Professor James Coyne yesterday posted online his letter to PLOS One complaining about the PACE authors’ failure to provide him with data from a paper published in the journal.
Coyne’s letter was premature because he had been misinformed that he would receive a response within 20 days rather than 20 working days. However, it indicated the seriousness with which he intends to pursue the request. The response – though not necessarily the data – is due by Friday, 11 December.
The authors of the £5 million PACE trial claim it showed that cognitive behavioural therapy and graded exercise therapy have some benefits for chronic fatigue syndrome but the study’s methodology and reporting have been heavily criticized.
And, Coyne told the PLOS One, “The author group has a consistent history of refusing requests to provide their data to other investigators… Richard Horton, editor of The Lancet, has gone on record with an estimate that the investigators have spent over 750,000 pounds in fighting requests to share their data.”
However, Coyne’s request breaks new ground. Authors must agree to make study data available to others as a condition of publishing in PLOS One and Coyne explicitly invoked that agreement when making his request.
Coyne told the journal, “If the PACE investigators refuse, they will be testing the commitment of PLOS to its policies and the scientific community will be watching… In the eventuality that I do not receive their data, I believe appropriate sanctions should be available for immediate application.”
Coyne’s is the latest attempt to have PACE data independently reanalysed. It follows two petitions (here and here) – one with over 11,000 signatures – and open letters from leading scientists and twelve ME/CFS organisations making similar requests.
He recently lambasted NHS Choices’ Behind the Headlines series for publishing an uncritical repetition of the PACE authors’ much-criticised claims that null long-term follow-up data from the trial favoured their interventions. He described how the news editor of Behind the Headlines used Twitter to broadcast, “Ran story about [chronic fatigue] syndrome, tried to be balanced as possible, still reckon few death threats”, followed by “ah f*** it, they’re too lazy to actually do it”.
NHS Choices has so far declined to remove the article and has issued no apology to patients for the behaviour of its employee, who remains in his post. (NHS Choices’ complaints procedure is described here. The email address for complaints is [email protected].)
Coyne recently told an audience in Edinburgh that “PACE really attracts my attention because it’s so goddamn bad. It’s bad in its conduct, it’s bad in its reporting, and it’s fascinating that it’s going unchallenged. And it’s uncritically being passed on by journalists and the media with clear harm to patients.”
He continues to use social media to bring the problems with the PACE trial to a wider scientific audience. His recent blog posts include:
- 29 October: Uninterpretable: Fatal flaws in PACE Chronic Fatigue Syndrome follow-up study
- 11 November: Why the scientific community needs the PACE trial data to be released
- 17 November: Data sharing policies: Do the Dutch do it better?
- 22 November: A “moral equivalent of war” and the PACE chronic fatigue trial
- 29 November: No Dissing! NHS Choices Behind the Headlines needs to repair relationship with its readers
- 2 December: What it takes for Queen Mary to declare a request for scientific data “vexatious”
- 4 December: Update on my formal request for release of the PACE trial data