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

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say that they have physical symptoms, but the clear message to therapists is that such symptoms are simply
“perceptions”. The therapists thus seem to be operating from a platform of pretence.
The therapists’ manual on GET says (page 24): “The more severely disabled group of CFS/ME patients were
excluded from previous studies as the studies involved an exercise test that may have been too challenging. However
due to greater levels of inactivity in the more severely disabled group, the deconditioning model should
apply equally if not more to these patients”, but in the participants’ material, certain words like
“deconditioning” are either absent or downplayed, yet in the therapists’ Manuals, “deconditioning” is at the
heart of the programme and is used throughout.
Such lack of openness in the patients’ material does seem to be misrepresentation. The Wessely School’s
“deconditioning” model of “CFS/ME” is not evidence‐based, let alone proven (indeed, it has been disproven
numerous times – see for example Twisk and Maes, Neuroendocrinol Lett 2009:30(3):284‐299), and it
contrasts with the biomedical model of ME/CFS that is supported by a respected literature of solid scientific
evidence.
3. The known adverse effects of the interventions used in the PACE Trial, especially GET (see Section 1
above), appear to have been down‐played by the Principal Investigators.
4. The assumptions of the Principal Investigators (ie. that there is no physical disease process) are frequently
stated as fact (see Section 4 below for actual quotations from the Manuals).
5. Sections 3 and 4 of this Report contain illustrations of what appear to be misrepresentation in the PACE
Trial literature: for example, in the PACE Trial Newsletter Issue 2 there is a “recruitment graph” purporting
to show actual recruitment compared with target recruitment and the two lines matched almost exactly (ie.
the projected recruitment was almost exactly the same as actual recruitment). From the documents obtained
under the FOIA, given that there were significant recruitment problems, this seemed improbable. The text
under the graph states: “All six hospital centres combined have not only managed to meet the revised recruitment
targets, but also to exceed them. This is a fantastic achievement for the trial team”. The important word in the text
is the word “revised” (ie. it shows actual recruitment versus “revised” target recruitment). Unless patients
(who may have been cognitively impaired) were paying close attention, this conveys the message that the
Investigators had no difficulties in finding participants and creates the (erroneous) impression that people
were flocking through the doors, which was not the case.
6. The Investigators’ hypothesis that is being tested in the PACE Trial (ie. that CBT and GET are effective
treatments for “CFS/ME” but that APT is not an effective intervention) is assumed by the Investigators (and
hence by the therapists) to have been proven, with therapists informing participants via the Manuals that
they can expect to recover with CBT and GET, but not with APT, which not only seems to be in breach of the
GMC regulations (Good Medical Practice 2006 – see below) but seems to show that the Principal
Investigators may have been inaccurate and may also have biased the trial from the outset by the way
information was presented to participants in a way that would favour the PIs’ desired outcome.
This is a serious concern, because participants in the CBT and GET arms of the trial were effectively being
told that “we already know the treatment you are to receive is effective and safe”, but those in the APT arm
of the trial were not given such reassurance. To give an unfair advantage to two arms of the trial by (a)
engaging the placebo response and (b) putting subtle pressure on participants to report feeling better even if
they did not feel better (because people want to please their therapists and may blame themselves if the
therapy does not work) is introducing an unacceptable bias into an MRC trial. Many people believe it
expedient of the Investigators to have withheld from PACE Trial Participants the fact that two of the
Principal Investigators withdrew from the Chief Medical Officer’s Working Group on CFS because they did
not agree with pacing, yet in the PACE Trial those same people are now claiming that CBT, GET and APT
are all forms of “pacing”.