I have worked since 2004 on identifying and publicising the serious substantive flaws in the PACE trial, as well as other flaws in psychogenic explanations of ME (and where ME is called 'CFS). I have produced a large amount of work on the subject, contributing to below the line comments in medical and scientific journals, and detailing my copious findings in my book "Authors of our Own Misfortune? The Problems with Psychogenic Explanations for Physical Illnesses" (published in 2012). I have also officially and publicly complained about the problems of the PACE trial, both at the beginning of the trial in 2004, and after its publication by the Lancet in 2011. I was therefore dismayed to see my own contributions, but more importantly my substantive findings, ignored in the series of three articles on PACE recently written by journalist David Tuller.
Not only were my findings ignored, so were those apparently of Professor Emeritus Malcolm Hooper, another major contributor to the flaws of the PACE trial. At the same time, there are some points made by Dr Tuller that appear to have originated from work undertaken elsewhere, including the One Click Group from 2004 onwards, and myself, that are not acknowledged as such by him. Neither Hooper's nor my own substantive complaints to Lancet and elsewhere, and the worrying responses, were acknowledged either in the Tuller series. I am not in any position to speak for Professor Hooper at all, and am not doing so here. I do not know his feelings on the matter. Nevertheless, I believe that there are key findings by him and his team, and grave problems in the way he has been treated for daring to bring these findings to official and public attention, that should also have been related in Tuller's series. Doctor Tuller was made aware of one of my own key findings, and my book, by me. I also offered further information. However he did not respond to the initial information at all once he had received it. Nevertheless, if he had, as he implies he did, performed a thorough literature search on advocacy critiques of the PACE trial, he would have become aware of the key work undertaken by myself, the One Click Group, and the Hooper team, as just three examples. A Google search will result in a large number of links to work detailing my own and others work on PACE, and the key, substantive criticisms we have made, above and beyond the outcome measures issue.
The issue of the outcome measures is important in itself, but nevertheless only forms part of the methodological, ontological and ethical problems of the PACE trial. Flawed methodology and ethical problems dogged the trial from the very beginning. There are enough major flaws and problems within the methodology to render the PACE trial and its resulting literature unsound enough to be retracted. However, Tuller's unfortunate failure to acknowledge some of those key flaws, as found by people like but not limited to myself, weakens what is actually otherwise a strong case for retraction of papers emanating from the PACE trial. It also strikes key events and work from the history of the PACE trial, thus rendering his account incoherent. That his series is being implied as a definitive deconstruction of the PACE trial, and as if Tuller himself had undertaken such a thing, also poses a massive risk to advocacy efforts to expose the many, key flaws of and dangers to patients caused by the PACE trial, which have grave implications for patient safety beyond the issues of the outcome measures.
For my own part, some major problems I have highlighted publicly and which are highly relevant to any discussion claiming to be explaining "the PACE trial: deconstructed" (Tuller's words), include but are not limited to:
1. Serious risks to clinical patient safety caused by unsound claims made about the efficacy of CBT and GET following the PACE trial;
2. Gross discrepancies between research and clinical cohorts, and how clinical patients (and the physiological dysfunction associated with them) appear to have been actively excluded from PACE and other research by the research group involved in PACE, which has, ironically, caused serious resulting risks to clinical patient safety in the UK in particular;
3. Related to the above, gross discrepancies in how various sets of patient criteria were used (and/or rejected), including but not limited to a changing of the London criteria by PACE authors from its original state, a set of criteria which was already controversial and problematic to start with for a number of reasons;
4. Failure of the PACE trial authors to acknowledge the range and depth of scientific literature documenting serious physiological dysfunction in patients given diagnoses of ME or CFS, and how CBT and GET approaches may endanger patients in this context;
5. The inclusion of major mental illnesses in the research cohort;
6. The distortion by PACE trial researchers of 'pacing' from an autonomous flexible management strategy for patients into a therapist led Graded Activity approach;
7. The post hoc dismissal of adverse outcomes as irrelevant to the trial, in direct contradiction to what is scientifically known about the physiological dysfunctions of people given diagnoses of Myalgic Encephalomyelitis or Chronic Fatigue Syndrome ;
8. The instability of 'specialist medical care' as a treatment category, and the lack of any sound category of 'control' group.
Other issues highlighted by other advocates include but are not limited to key conflicts of interest of the PACE trial researchers, and the strange role of the Department of Work and Pensions in funding the PACE trial and the ideological basis of that funding. This in particular is a serious ethical issue, especially in light of subsequent UK state policy toward disabled people, and the proposed use of CBT and coercive 'treatments' in this policy, to the point the UK government is now being investigated by the United Nations for its treatment of disabled people. The problems of the PACE trial are many and complex, which is why it presents such a danger to patient safety, and why a careful, methodical consideration and acknowledgement, by scientists, of all of its flaws, is desperately needed, with a view to urgent retraction of the original paper at least, and preferably all papers emanating from the PACE trial.
Over the years I have worked very hard to find scientists willing to consider carefully the copious evidence I and others have collected about the flaws in the PACE trial, so far without success. There is not even a way to enforce the 'Declaration of Helsinki', it appears. At one point I had a surreal email conversation with the Lancet Ombudsman about his own conflict of interest, where I was left wondering if I had actually conjured up the idea of conflicts of interest myself, perhaps in a fevered dream. The PACE trial and its methodological and ethical flaws provide an exemplar of how principles of science can be corrupted by ideology and power structures within science, a human practice, itself.
Doctor Tuller should have carefully worked to ensure the relevant history of the PACE trial, and all the major substantive concerns made by advocates, were adequately aired in his series, and that the various 'experts' he cites were made fully aware of them. Indeed, he had a ethical duty to the M.E. community to ensure this. In its current state, this series of articles is seriously incomplete at best, and has in effect stricken valid criticisms off the public agenda, which is likely to have a devastating effect on the prospects for safety and fair treatment of an already beleaguered, stigmatised and ignored patient community. I believe at the very least Doctor Tuller has an ethical duty to amend his series to reflect the fact that people such as (but not limited to) myself, Jane Bryant of the One Click Group, and Malcolm Hooper have found major methodological and ethical problems in the PACE trial and made official complaints about them (some even before the trial got underway, as well as post-publication), even if Tuller is unable to discuss or summarise these himself, whatever his reasons. But it would frankly be more useful if he also undertook in the future to consider, understand and wherever possible support the findings of other advocates, if he believes that the issue of PACE and its problems are now important to him.