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Socio‐economic data was to be collected even before a participant was carefully chosen by the Wessely
School: the Protocol states:
“Where the patient is thought to be suitable by the clinic doctor…and the patient agrees to be assessed for eligibility,
the clinic doctor will forward the patient’s contact details to the RN (research nurse). The RN will contact the patient
to arrange the first research visit”.
If only the patients who were “thought to be suitable” by the clinic doctor for inclusion in the “randomised”
MRC PACE Trial were chosen, this would seem to introduce a source of possible bias, because it is only if
the Wessely School clinic doctors deemed the patient to be eligible that patients were told about the Trial by
the clinic doctor (yet the original intention was to recruit consecutive new patients at the CFS Clinics, which
was subsequently amended to include patients who had previously undertaken a programme of CBT).
The next pre‐trial assessment was at Baseline Visit 1, which set out to collect personal data that seems to
have little bearing on a clinical trial but could be of value to the DWP and the permanent health insurance
industry.
The collected data included not only the customary demographic details, date of birth, age, sex, ethnicity,
marital or partner status, years of education, occupation (the latter would obviously afford information
about a participant’s earnings) but also current and specific membership of a self‐help group.
“After visit 1 the research nurse will discuss the patient’s potential eligibility with the centre leader”, so once again it
was only if the potential participant’s data was deemed suitable for the Wessely School’s purposes that the
patient was allowed to enter the Trial. Was this true randomisation as participants were led to believe
(Pacing, Activity, and Cognitive behavioural therapy, a randomised Evaluation)?
Participants selected in this way may not be deemed to be a representative patient cohort and the data
generated should thus only be extrapolated to an identically‐selected population, which could nullify the
PACE Trial Investigators’ claim that the trial is “randomised”.
In October 2002 The Lancet’s Department of Ethics published a report setting out guidelines to protect
participants in clinical trials; key points are:
“Clinical reports typically include a statement that the research protocol was approved by an ethics review committee,
and that informed consent was obtained from participants.
“Studies that have morally controversial features, such as….deception, might be dismissed as unethical unless the
rationale for including such features and details of safeguards to protect research participants from…exploitation are
explained.
“Studies in which participants are deceived should discuss why such a measure was deemed necessary, and how
informed consent was obtained.
“One could argue that there is no need to burden researchers with the task of describing ethical matters, provided that
studies have received previous review and approval by an ethics committee” (FG Miller et al. Lancet 2002:360:1326‐
1328).
It is easy for researchers to side‐step ethical issues by ascribing responsibility to an ethics committee, but in
the case of the MRC PACE Trial, it seems that the West Midlands MREC did not have the necessary grasp of
the issues involved; the question therefore arises as to why this was so and why they commended Peter
White on the trial’s design when it seemingly did not conform to even elementary rules of procedure.