By Dr Neil MacFarlane MRCPsych in DrNMblog.
This was submitted (December 2020) to NICE in response to the new draft ME/CFS guidance of November 2020, which had removed the recommendation for Graded Exercise Therapy (GET), and downgraded CBT from therapeutic to a ‘supportive’ option.
I appear to be the first UK psychiatrist to be openly critical of the PACE trial.
The PACE trial was seriously unethical. The senior researchers continue to deny this, despite the clear evidence. Therefore the trial is not only at ‘high risk of bias’, but at significant risk of fraud, and it should be retracted as a trial of treatments.
As pointed out in the ‘Open Letter to The Lancet’ of November 2015 by Davis, Edwards et al the PACE trial violated the 2000 revision of the World Medical Association’s Declaration of Helsinki, which (my emphasis) clearly stated: ‘In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail.’
To read the rest of this story, click on the link below: