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

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trials…are open to the charge of exploiting the vulnerable by taking advantage of their lack of options and their
dependency on researchers for medical care…” (http://www.springerlink.com/content/ph8032w107213410/ ).
Moreover, calling one arm of the trial “SSMC” (Standardised Specialist Medical Care) seems potentially
coercive because it gives the impression that participants will be receiving specialist medical care (ie. the
best medical care available), which clearly is not the case: “SSMC” may consist of doing nothing at all apart
from general advice from a doctor at a Fatigue Service Clinic on balancing activity with rest.
Quite certainly, the West Midlands Multi‐centre Research Ethics Committee wrote to Peter White on a
number of occasions expressing concern that the wording of the Patient Information Sheet was potentially
“coercive”; he argued that it was not, but eventually he agreed to modify the wording. That it should have
been deemed by the West Midlands MREC to be “coercive” in the first place is disturbing.
PACE Trial entry criteria
The entry criteria for the MRC PACE Trial are the Wessely School’s own criteria (Oxford 1991).
This is remarkable, given that one of the Principal Investigators himself stated in 1997 that the Oxford
criteria “have been superseded by international consensus” (Chronic fatigue syndrome and occupational health.
A Mountstephen and M Sharpe. Occup Med 1997:47:4:217‐227).
However, contrary to accepted scientific practice, those superseded criteria were deliberately chosen in
order to enhance applicability to as large a number of “fatigued” people as possible and thus to enhance
recruitment to the trial.
The Trial Identifier states at section 3.6:
“Subjects will be required to meet operationalised Oxford criteria for CFS. This means six months or more of medically
unexplained, severe, disabling fatigue affecting physical and mental functions. We chose these broad criteria in
order to enhance generalisability and recruitment”.
Deliberately to broaden entry criteria for a clinical trial so that they include patients who do not have the
disorder in question would seem to contravene elementary rules of scientific procedure.
As noted throughout this Report, the Oxford criteria were described at the time by one of the co‐authors:
“British investigators have put forward an alternative, less strict, operational definition which is
essentially chronic (6 months or more) …fatigue in the absence of neurological signs, (with) psychiatric
symptoms…as common associated features” (A.S. David; BMB 1991:47:4:966‐988).
That is not a definition of ME.
No researcher hoping for scientifically valid results would choose inclusion criteria based on the desire for
enhanced recruitment to the trial, nor would s/he allow broad inclusion criteria for “generalisability” if this
meant that specificity was destroyed, thus rendering the data imprecise and effectively meaningless.
McGee et al recommend that:
“Authors should define the population to whom they expect their results to be applied” (BMJ 1999:319:312‐315).