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

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Any failure to make “full disclosure” is a material concern in a clinical trial and it seems that PACE Trial
participants were not informed about key issues, including the following:
1. The Investigators believe “CFS/ME” to be a behavioural disorder and consequently failed to take account
of the extant literature, which is a very serious issue in a clinical trial.
It is not credible to think that the PACE Trial Investigators are or were unaware of the considerable body of
international evidence about the nature of the disorder in which they profess to be experts, or about the
evidence showing that CBT is not an effective treatment for ME/CFS; indeed, Simon Wessely is on record
numerous times saying so (see “Conflicting information” above ).
It must not be overlooked that one of the Principal Investigators, Professor Trudie Chalder, is on record as
asserting that “CFS” is a “classical psychosomatic” disorder described as “a psychiatric illness with marked
physical symptoms” (see Section 1 above), but this belief was withheld from participants involved in the
PACE Trial. If full disclosure had been made to potential participants, it is unlikely that they would have
agreed to take part in the PACE Trial.
What is so striking is that participants are not only having this necessary information withheld from
them but, via the Manuals, they seem to be being repeatedly misinformed about the nature of ME/CFS
and about the efficacy of CBT/GET (see Section 4 below). This immediately reduces their autonomy and
their choice.
The empirical evidence is that, far from being “somatisers”, the vast majority of people with ME/CFS are
quietly courageous and adjust astonishingly well to the huge disability they face, especially given the
degree of medical disinterest, denigration and social isolation. Such adjustment should be seen as a
triumph of strength, not as maladaptive behaviour as the Wessely School assert.
2. To inform therapists but not participants that CBT and GET work on the premise of there being no
pathology in “CFS/ME” (placating participants by telling them that there are “physiological” disturbances,
which the PIs in reality believe to be due to deconditioning) seems not only to misrepresent the facts about
ME/CFS (because, as illustrated in Section 2 above, there is abundant evidence of underlying pathology in
ME/CFS) but, according to Professor Paul Cheney, may even potentially endanger the life of any participant
with true ME who may have serious and significant cardiovascular dysfunction.
According to Miller et al, deception of research participants is incompatible with informed consent and
clearly conflicts with the ethical norms governing clinical research. It violates the principle of respect for
patients by infringing their right to choose whether or not to take part in the research that must be based on
full disclosure of all relevant information (FG Miller et al. PloS Medicine 2005:2:9:0853‐0859).
Patients expect to be able to trust in, and to receive comprehensively truthful communications from,
clinicians and clinical investigators, but in the case of the PACE Trial, participants were not told that the
Trial was predicated on the assumption that they do not have a physical disease, which many people
regard as deceiving participants.
Miller et al argue that clinician investigators who deceive patients in the course of research are acting
fraudulently (FG Miller et al. PloS Medicine 2005:2:9:0853‐0859).
On page 28 of the therapists’ CBT Manual in the table “Distinguishing Between APT, CBT and GET” it states
that CBT and GET do not – as noted above in this section ‐‐ work from a pathological assumption. This is a
clear statement from the Wessely School that they do not believe ME/CFS patients have a physical illness,
yet the Manuals train therapists to let participants think that they do accept it as a physical illness.
Therapists are explicitly told to use “biomedical language” and are warned not to challenge patients who