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

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(8) The Investigators did not include essential pre‐trial cardiovascular screening and specifically stated that
if a participant suffered a stroke during the trial, such an event would not necessarily count as a Severe
Adverse Reaction to treatment (Minutes of Trial Steering Committee meeting, 22 nd April 2004, point 10).
(9) The Investigators chose a six minute walking test as “an objective outcome measure of physical capacity”.
According to the CMO’s Working Group Report of 2002 (page 47): “Perhaps the prime indicator of the condition
is the way in which symptoms behave after activity is increased beyond what the patient can tolerate. Such activity,
whether physical or mental, has a characteristically delayed impact, which may be felt later the same day, the next day,
or even later…In some instances the person can sustain a level of activity for several weeks, but a cumulative impact is
seen, with a setback after several weeks or more”. Moreover, the Chief Investigator himself, Peter White, has
published evidence supporting the need for serial post‐exercise testing ‐‐ see “Immunological changes after
both exercise and activity in chronic fatigue syndrome: a pilot study”. White PD, KE Nye, AJ Pinching et al.
JCFS 2004:12 (2):51‐66 ).
(10) The Investigators originally intended to obtain a non‐invasive objective measure of outcome using post‐
treatment actigraphy but abandoned this on the grounds that wearing such a monitor would be too great a
burden at the end of the trial (http://www.biomedcentral.com/1471‐2377/7/6/comments). Therefore, after
spending millions of pounds of public money and involving hundreds of people in an intensive regime,
they completely fail to obtain objective measurements that would reveal whether or not the interventions
are successful.
(11) The PACE Trial results will be based on participants’ subjective responses to questionnaires. This is of
particular concern when two of the interventions being tested (CBT and GET) specifically encourage
participants to re‐interpret their symptoms as not resulting from disease but as normal responses to exercise.
Moreover, a study from 1997 demonstrated the problem of using self‐reported data in ME/CFS patients
(Vercoulen JH, Bazelmans E, Swanink CM, Fennis JF, Galama JM, Jongen PJ, Hommes O, Van der Meer JW,
Bleijenberg G. Physical activity in chronic fatigue syndrome: assessment and its role in fatigue. J Psychiat
Res. 1997 Nov‐Dec; 31(6):661‐73). The authorsʹ reason for the study was because: ʺIt is not clear whether
subjective accounts of physical activity level adequately reflect the actual level of physical activity….we evaluated
whether physical activity level adequately can be assessed by self‐report measures”. The authors evaluated the
correlations on seven outcome measures in relation to the actometer readings and demonstrated that “none
of the self‐report questionnaires had strong correlations with the Actometer”. Having evaluated whether physical
activity level can be adequately assessed by self‐report measures, the authors found that “self‐report
questionnaires are no perfect parallel tests for the Actometer” and that subjective questionnaires “do not measure
actual behaviour” because “responses may be biased by cognitions concerning illness and disability”.
The authors continued: “In earlier studies of our research group, actual motor activity has been recorded with an
ankle‐worn motion‐sensing device (actometer) in conjunction with self‐report measures of physical activity. The data of
these studies suggest that self‐report measures of activity reflect the patientsʹ view about their physical activity and
may have been biased by cognitions”.
There is thus evidence that alleged improvements reported in subjective questionnaires may not be reliable.
Furthermore, a study on (ME)CFS patients in the US by Friedberg et al that used CBT and which also
encouraged activity found on actigraphy measurements that there was in fact a numerical decrease from the
pre‐treatment baseline (Cognitive‐behaviour therapy in chronic fatigue syndrome: is improvement related
to increased physical activity? J Clin Psychol 2009, Feburary 1).
(12) The PACE Trial Investigators did not disclose important information, for example, their own conviction
that the participants do not have a physical disease, and their own assumption that two of the interventions,
CBT and GET, do not work from a pathological perspective, only from a psychiatric perspective, which
could mean that participants were not in a position to provide fully informed consent.