I was without Internet until my plane from Zurich touched down in Philadelphia. Gmail wasn’t loading as we taxied in on the tarmac. As a result, my first notification of the Queen Mary University London (QMUL) release of the PACE chronic fatigue syndrome trial data was a direct Facebook message from an Irish student, Aine Hefferon.
Aine’s message contained a link to an excellent commentary describing the events leading up to the release. It notes:
The data was requested in March 2014 by Alem Matthees, in order to allow the calculation of the trial’s main outcomes and recovery rates according to the methods specified in the trial’s original protocol. The original analysis methods were abandoned once the trial was underway and replaced by others, including an analysis in which patients could become more disabled and yet be classed as having “recovered”.
Tom Kindlon, a patient whose criticism of PACE’s analyses has been published in medical journals, said, “This is a great day for patients. We’ve waited years for this. Finally, it’s going to be possible for independent parties to scrutinise the data and, in particular, find out what the results would have been without all the unjustified changes to the study protocol. Looking at how the objective data relate to the subjective outcomes will also be very interesting.”
He added, “This was a publicly funded trial and cost £5 million in taxpayers’ money — the data should never have been kept secret. It is very disappointing that both the PACE Trial investigators and QMUL fought the case so hard, forcing Alem Matthees to have to put in so much work when he is not well himself, and dismissing some other requests for basic information.”
The day before the data was released, the PACE authors published online the main results for the trial using the original protocol-specified methods. The new results show that only a third as many patients improved according to the protocol-defined analysis, compared to the numbers reported in The Lancet in 2011.
Because the data are being released as a result of a Freedom of Information Act request, the data will be publicly available for all to analyze. I doubt there will be any surprises for those of us who have long suspected, with good reason, that the PACE investigators based their claims of the efficacy of cognitive behavioural therapy (CBT) and graded exercise therapy (GET) on protocol violations including switching of key primary outcome variables and suppression of the secondary objective data.
I’ve noted that this release of the data is independent of my request of data from the investigators which were promised as a condition for publishing another, cost-effectiveness analysis paper in PLOS One. My request was not made under the Freedom of Information Act, but was construed as such by the PACE investigators. They refused the request and labeled me as “vexatious” for having made it.
Months after posting a comment that could be construed as an Expression of Concern (but not explicitly labeled as such), PLOS One has neither obtained the data for me nor retracted the journal paper for violation of the terms under which it was published. Downloads of the paper from the website still carry no indication of its status as questionable science.
I continue to be blocked from blogging about the situation at the PLOS blog Mind the Brain, despite my previous blog post about the PACE trial having been one of the most accessed of any thousands posted on the large family of PLOS blog posts of 2015.
As one of PLOS One’s Academic Editors, I will continue my refusal to receive papers until I have a discussion with Iratxe Puebla, Managing Editor for PLOS ONE that is moderated by an independent third party. A fruitful discussion would involve the journal publicly acknowledging the vaguely communicated ban on my blogging about the trial that resulted in my access to the blog temporarily being blocked in December 2015 with all posting of commenting by readers being stopped as well. The discussion would also involve disclosure of the one-sided, non-transparent process that has occurred with Queen Mary University London and the PACE investigators, to the exclusion of other key stakeholders.
I’m not holding my breath until that occurs. I am announcing three steps that will take place in the near future.
- I will this week test the status of routine data-sharing in the United Kingdom with a formal request for data from a paper published in The Lancet. Access to the data are necessary for independent evaluation of dubious claims being made that behavioural activation for depression delivered by minimally trained providers is suitable for replacing CBT delivered by clinical psychologists.
- I will provide scientifically – and ethically- based arguments why the parents in the UK should consider not enrolling their children in the MAGENTA trial and why they should withdraw their children if they have already consented to their participation, until certain conditions are met. It would be wise for the investigators conducting a trial to suspend recruitment until some key issues are considered.
- I will resume a dialogue with Dr David Tovey, Editor in Chief, The Cochrane Library, and Deputy Chief Executive Officer about the need to rectify the situation in which the PACE investigators intruded upon what should have been an independent Cochrane review of graded exercise for chronic fatigue syndrome Armed with new evidence produced in the Tribunal and subsequently, I will argue that the review should be withdrawn or have an appropriate Expression of Concern attached. Furthermore, the Cochrane should re-organize the ill formed and misnamed Common Mental Disorders Group so Myalgic Encephalomyelitis/Chronic Fatigue Syndrome is excluded. Considering ME/CFS as a “mental disorder” is out of sync with the rest of the world, where these conditions are considered physical illnesses. Putting these physical disorders under the rubric of common mental disorders is archaic and a blatant concession to vested interests in the UK.