MRC PACE Trial Complaint, Sent on behalf of Professor Malcolm Hooper:
This ethics committee approval was granted even though the design of the Trial did not accord with the elementary research requirement for as homogeneous a cohort as possible in a clinical trial (ie. it intentionally included those who do not suffer from the disorder allegedly under investigation, substantial evidence of which exists).
Of cardinal concern was the fact that the Trial entry criteria (ie. the Oxford criteria: JRSM 1991:84:118-121) do not include those with the pathognomonic symptom of ME/CFS (post-exertional fatigability with malaise) but select those with chronic “fatigue” and persistent tiredness, which bear no relationship to post-exertional fatigability (indeed the Oxford criteria suggest those with neuromuscular disease be used as controls), yet the Principal Investigators insist that they are studying those with ME/CFS, a recognised neurological disorder.
The Chief Principal Investigator, Professor Peter White, apparently failed to inform the West Midlands MREC of this salient disparity.
Also ignored by the MREC was the fact that ... Read more>>