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

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SECTION 4: QUOTATIONS FROM THE MRC PACE TRIAL MANUALS
General observations on the PACE Trial Manuals and Leaflets
The most striking impression is that the Manuals are ill‐written, often grammatically incorrect, lacking in
intellectual rigour and internally inconsistent.
They are also carelessly written: for example, a “medical specialist” in one sentence suddenly becomes a
“therapist” in the next.
Although the Minutes of the Joint Trial Steering Committee and the Data Monitoring and Ethics Committee
meeting that was held on 27 th September 2004 record: “Professor Darbyshire noted that the term CFS/ME has not
been used consistently”, the disease is variously referred to as “chronic fatigue”, “chronic fatigue syndrome”,
“CFS”, “ME”, “Myalgic Encephalomyelitis”, “Myalgic Encephalitis” or as “Myalgic Encephalopathy”, hence
despite Professor Darbyshire’s concerns, these inconsistencies remain uncorrected.
It appears that there is nothing in the Manuals that approaches either medical science or logic, or
indicates that the authors have any understanding of the true nature of the neuroimmune disease
ME/CFS.
Speculation is portrayed as fact. Assumptions are portrayed as “evidence”.
For example, on page 17 in the CBT Therapists’ Manual the authors say: “There is a growing body of evidence
that is suggesting that a number of factors may be involved in triggering the illness”, but on page 18 this becomes:
“Just as there are many factors involved in triggering CFS/ME, there are also many factors that are involved in
sustaining it” ‐‐ so a “suggestion” that “a number of factors” are involved in triggering “CFS/ME” has
become an established fact, despite being unproven.
Given the existing published evidence‐base about ME/CFS, how such a Trial was approved by any Ethics
Committee is bewildering.
The significance of a particular comment in a Manual cannot be captured without reading the full Manual
and by cross‐referencing with other Manuals in order to discover the many contradictory and
unsubstantiated statements.
It could be argued that participants were not in a position to give fully informed consent to the interventions
described in the Manuals (for example, participants in both the CBT arm and the GET arm of the Trial were
to be treated as though they had no physical disease, but this important fact was withheld from them).
It is notable in this respect that Lord (David) Sainsbury of Turville, who at the time was responsible for the
MRC, stated in the House of Lords: “Because the trial participants will have provided informed consent, they will
receive no compensation if they become more ill, whether or not as a result of the particular treatment” (Hansard
[Lords]: 18th November 2004: 4830) and participants were to be informed that: “we don’t expect to see any
harmful effects caused by our study. However, you need to know that there are no special compensation arrangements
if you are harmed because you have taken part” (SSMC Participant Information Sheet for PACE Trial).
The Manuals are full of contradictory claims – for example, the CBT Manual for Therapists states that they
are treating some participants “who generally do too much”, which entirely vitiates the premise upon which
the whole PACE Trial is based, ie.“the illness model of both deconditioning and exercise avoidance”, since it is
obvious that people who generally do too much do not suffer from exercise phobia and cannot be
deconditioned.