Firstly I am no expert in law, science, ethics, statistics or any area covered by this article; I am just a layman.
[Image description: histogram table comparing PACE triallers' stated effectiveness of given treatments compared to results recalculated by independent statisticians & M.E.-supporters, demonstrating the exaggeration by the triallers and proving no "statistically significant advantage" for posited treatments. Taken from & © http://www.virology.ws/2016/09/21/no-recovery-in-pace-trial-new-analysis-finds/]
We are twelve months on from the publication of the statistical review of the data released, after a court order to do so, by the PACE triallers. That review demonstrated that the triallers massively over-exaggerated success rates. Since then, PACE has been heavily criticised my scientists, academics, statisticians and M.E.-sufferers, and lampooned for its blatant disregard for science let alone fact or reason.
My understanding is that the ethics committee that approved the original protocol for the PACE trial
is responsible throughout the process for ensuring that the trial was
run ethically and responsible for oversight of the trial. When the
protocols were altered the ethics committee was thus accountable for
approving any changes. In this instance the changes appear now to have
significantly altered the trial to such an extent that the ethics committee was obligated to refer the matter back to the trial's funders to
ensure that they also were content for the revised trial to proceed.
If this is correct, then - assuming they were apprised by the ethics
committee - the funders are culpable as well as those who conducted the
trial for the misinformation and thus all subsequent harms. A class action or similar, in order to obtain collective redress for harms done, would therefore seem appropriate against inter alia the Department
for Work & Pensions (DWP) and the Department of Health (DoH).
Were they not informed, then the ethics committee is culpable and its
members should be brought before their respective professional panels
for appropriate disciplinary action.
Additionally, I should have
thought that those who led the PACE trial ought now also to be held to
account before their own professional bodies for the serious failings in
their conduct. I imagine they also might be considered co-respondents
in any class action (or similar) case.
Even were any such class action (or similar) to
ultimately fail, it would at the very minimum raise awareness of the
utter uselessness of the PACE trial's alleged results and thus lead to changes in support in the medical establishment for cognitive behaviour therapy (CBT) & graded exercise therapy (GET) for people with M.E. (pwme).
Any thoughts?
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