MAGICAL MEDICINE: HOW TO MAKE AN ILLNESS ... - Invest in ME

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wrote to the West Midlands MREC seeking permission to implement changes that had been set out on page
35 in the Full Protocol dated 1 st February 2006 which had the specific aim of increasing recruitment (the SF‐
36 cut off point had been changed from 75 to 60 but was then changed again). Up to December 2005 (when
the changes took place), the Investigators had excluded 65 people from 140 applicants. Thirty‐six people had
scored too highly on the SF‐36 (so were deemed too well to take part in the Trial) and twenty‐nine people
had previously undertaken the treatment that was on offer in the PACE Trial (CBT/GET); thus 46.43% of 140
applicants had originally been rejected, but such people were then to be invited to take part.
Additionally, despite the Trial Identifier having stated at section 2.5 “We will not recruit directly from primary
care because we wish to compare the efficacy of these treatments in patients whom GPs regard as requiring additional
help and who are likely to have a worse prognosis”, in apparent desperation to reach their recruitment target,
Peter White sought to advertise their trial to GPs, abandoning the protocol by which they intended to recruit
“consecutive new patients” attending CFS clinics and seeking patients directly from primary care. In his letter,
Peter White virtually begged GPs to send anyone who suffered from “chronic fatigue (or a synonym)” to a
PACE Trial Centre. This means the Investigators are likely to have included people who are “tired all the
time” (TATT), which bears no relationship to ME.
Furthermore, the Trial Identifier states at section 3.6: “The RN (research nurse) will use a standard psychiatric
interview…to exclude those with…a chronic somatisation disorder”, but the Minutes of the Joint Meeting of the
Trial Steering Committee and Data Monitoring and Ethics Committee held on 27 th September 2004 record at
point 12: “Professor White noted that there were… changes already planned for (the Medical Screening Standard
Operating Procedure [SOP]): Under medical history, patients with hyperventilation or somatization disorder
would not be excluded. The TSC were happy with this document. Julia De Cesare to re‐word the Medical
Screening Standard Operating Procedure according to Professor White’s recommendations”. Clearly, therefore,
Professor White recommended that people with somatisation disorder were to be included in the PACE
Trial that purported to be studying those with “CFS/ME”. The Trial Steering Committee and Ethics
Committee apparently had no problem in agreeing to this further dilution of the trial cohort even though the
trial was underway.
Deliberately to include those with known psychiatric disorder in a trial that purports to be studying those
with a classified neurological disorder undermines the rules of scientific inquiry.
It cannot be denied that the PACE Trial Investigators changed the design of the Trial as they went along,
which must surely undermine the reliability of all conclusions to be drawn from the data, not least because
the first 75 participants recruited met different entry criteria from those who were recruited later.
This can only mean that, because the entry criteria had been diluted, people in the second tranche were less
ill. It cannot be otherwise, even mindful that the Oxford criteria are wide enough to capture almost anyone
(at the MERUK International Research Conference held on 25 th May 2007 at the University of Edinburgh,
Canadian psychiatrist Eleanor Stein said in her keynote lecture about the Oxford criteria that they: “could
describe almost anybody”).
(5) The Investigators failed to take account of the extant literature about the disorder in question, which is a
very serious issue in a clinical trial and is normally a pre‐requisite.
(6) The Investigators mis‐portrayed ME/CFS as a dysfunctional belief instead of a multi‐system serious
neuroimmune disorder.
(7) Even though they acknowledge they do not know what causes “CFS/ME”, in the CBT and GET arms of
the trial the PIs assumed that participants have no physical disease but did not inform participants of this
and portrayed their own assumptions as established facts, which is misleading.