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

351
to be a consequence “of too much inactivity”; performing a muscle biopsy before and after the PACE Trial
would have been a useful and objective measure of mitochondrial abnormality; even minimally invasive
tests to measure lactic acid and mitochondrial function before and after GET would have been useful and
objective measures of the efficacy of GET).
At this point, the therapists are taught about how the various sessions of “therapy” are to be implemented.
In Phase 1 (covering sessions 1‐3), therapists must explain what is required of the participant; they must
“engage the participant in GET model and explain reversibility” (ie. they are effectively promising a cure);
therapists must carry out “an assessment of motivation to exercise”; they must carry out a “brief physical
assessment”, but therapists are then told: “objective measures and fitness assessment will already have been
conducted prior to your assessment, and this data passed on to you. You will not receive any actigraphy data”
(another contradiction: “objective measures will already have been conducted” but “you will not receive any
actigraphy data”: the actigaphy data is the only objective measure, so why deny the therapists this
information? Is the reason because Professor White decided that no actigraphy data for comparison will be
obtained at the end of the trial?).
Therapists are told that: “Participants will already have undertaken a thorough physical assessment”. A short level
walking test is far from a thorough physical assessment, and no serial testing was being carried out. A
patient with ME/CFS may be able to perform an activity on one occasion but will typically relapse after a
day or so, hence the need for serial testing. A one‐off test cannot be considered objective, given the evidence
of delayed response to activity seen in ME/CFS. The fact that the therapist is instructed to repeat the level
walking test after one minute of recovery, when the heart rate and Borg Scale are to be repeated, is of
doubtful value in patients with ME/CFS, especially as the correlation between the Borg Scale and the heart
rate is known to be weak in any case, yet this appears to be the main “objective test” in the trial.
Much space is devoted to the Borg ‐ HR (heart rate) relationship, apparently without understanding that it
may have little application for people with ME/CFS. The Borg Scale has been shown to be higher in people
with ME/CFS than in controls.
The Borg Scale is used by sports coaches and by personal trainers to measure athletes’ and body‐builders’
levels of intensity in training; it measures perceived exertion. In medicine, it is used to document the
patient’s exertion during a test and includes a measure of breathlessness in relation to heart rate (HR).
Still in Phase 1, therapists are taught that: “The main purpose of engaging the participant in the model is to allow
the participant to understand the multifactorial influences exercise can have on their health and CFS/ME recovery” .
It is not ethical in a trial to tell the participants in one arm of the trial that the “treatment” they are receiving
can lead to recovery. The participants have a right to know that people who have undergone GET have
been made severely and permanently worse by it (see Section 1 above).
The therapist is next taught about “boom and bust” patterns of behaviour which the authors assert occur in
participants: “over activity may lead to an increase in rest and a decrease in fitness and function if prolonged”.
Unfortunately, the authors’ explanation is illogical. Assuming (i) that the participant is in a “boom and bust”
pattern of activity and (ii) that the deconditioning hypothesis is correct, then after every “bust”, the person
would deteriorate and not return to their prior level of fitness, ie. for the assumptions to be correct, one
would expect to observe progressive deterioration in all ME/CFS patients, but this is not the case, hence one
of these assumptions is incorrect.
The therapists are informed: “Many people with CFS/ME find…there is a significant post‐exertional response” (all
people with ME/CFS experience a post‐exertional response: if they do not exhibit this cardinal feature of
ME/CFS, then they do not have ME/CFS and should not be in the PACE Trial).