The Journal of Healthy Psychology has published a special issue focusing on the PACE trial – originally published in The Lancet (2011).
Prof. Malcolm Macleod, Professor of Neurology and Translational Neuroscience, University of Edinburgh, said:
“The PACE trial, while not perfect, provides far and away the best evidence for the effectiveness of any intervention for chronic fatigue; and certainly is more robust than any of the other research cited. Reading the criticisms, I was struck by how little actual meat there is in them; and wondered where some of the authors came from. In fact, one of them lists as an institution a research centre (Soerabaja Research Center) which only seems to exist as an affiliation on papers he wrote criticising the PACE trial.
“Their main criticisms seem to revolve around the primary outcome was changed halfway through the trial: there are lots of reasons this can happen, some justifiable and others not; the main think is whether it was done without knowledge of the outcomes already accumulated in the trial and before data lock – which is what was done here.
“So I don’t think there is really a story here, apart from a group of authors, some of doubtful provenance, kicking up dust about a study which has a few minor wrinkles (as all do) but still provides information reliable enough to shape practice. If you substitute ‘CFS’ for ‘autism’ and ‘PACE trial’ for ‘vaccination’ you see a familiar pattern…”
Dr Neha Issar-Brown, Programme Manager, Population and Systems Medicine at the Medical Research Council (co-funders, along with the National Institute for Health Research, of the PACE trial), said:
“The Medical Research Council funded and supported the PACE trial after subjecting the research proposal to a robust peer-review process involving experts in the field, as is the case with all our funding decisions. This included ensuring adherence to standardised trials methodology and design principles. The researchers’ findings were then peer-reviewed before publication in journals. All research evolves by continually re-evaluating existing evidence and looking for new knowledge and we would always welcome high-quality research applications to better understand the underlying disease mechanisms, causes, prevention and treatments for this extremely debilitating condition.”
A spokesperson for University of Oxford said:
“The PACE trial of Chronic Fatigue Syndrome treatments was conducted to the highest scientific standards and scrutiny. This included extensive peer review from the Medical Research Council, ethical approval from a Research Ethics Committee, independent oversight by a Trial Steering Committee and further peer review before publication in high-impact journals such as The Lancet.
“The allegation that criteria for patient improvement and recovery were changed to increase the reported benefit of some treatments is completely unfounded. As the study authors have repeatedly made clear, the criteria were changed on expert advice and with oversight committee approvals before any of the outcome data was analysed.
“Oxford University considers Professor Sharpe and his colleagues to be highly reputable scientists whose sole aim has been to improve quality of life for patients with ME/CFS. While scientific research should always be open to challenge and debate, this does not justify the unwarranted attacks on professionalism and personal integrity which the PACE trial team have been subjected to.”
* ‘Special Issue on The PACE Trial’ edited by David Marks published in Journal of Health Psychology on Monday 31st July 2017.
Prof. Macleod: “Prof Sharpe used to have an office next to my wife’s; and I sit on the PLoS Data board that considered what to do about one of their other studies.”
Dr. Issar-Brown: Nothing to declare