The PACE trial should be retracted, because it was seriously unethical, and the lead investigators continue to deny that, by Dr Neil McFarlane in DrNMblog, 19 March 2021
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.
My submission:
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…
…The PACE trial may be of some historical interest and even future relevance in relation to depression and anxiety in ME/CFS, and on the issue as to whether CFS might validly be considered a separate condition from both ME and depression, as appears to be the view and experience of some patients and some PACE-independent professionals.
The reported rates of anxiety syndromes plus depression (47%) and depression alone (34%) were high. Many people do find CBT helpful as a form of support for those conditions, so it is reasonable for NICE to recommend CBT as a form of support, but a caution should be added about the risk of harm, especially if coercion might encroach. This caution might be reinforced by adopting the term ‘cognitive behavioural support’, or ‘CBS’, in place of ‘CBT’. NICE should also recommend research into other forms of psychosocial support.
The reported rate of ‘post-exertional malaise’ (PEM/PENE) was also high (82-87%), suggesting that its presence or absence cannot be used as the sole criterion for ME/CFS. That is an issue which continues to concern ME/CFS patients and PACE-independent professionals, and therefore justifies further research, especially on the question of whether some people with non-ME/CFS depression have similar PEM. If there is a separate ‘CFS’ entity, then the nature and degree of PEM in that would also be relevant.
