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

Assumptions made by the Trial Investigators
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The Trial outcome is based on assumptions: “At one year we assume that 60% will improve with CBT, 50% with
GET, 25% with APT and 10% with UMC” (usual medical care, which is not defined and as noted above, is
generally accepted to be non‐existent for ME/CFS).
The PACE Trial statistician, Dr Tony Johnson, is on record as stating about the trial: “In designing a clinical
trial (of CBT/GET) we have to estimate the number of patients”; “Estimation essentially requires a guess at what the
results will be”; “‘In guessing what the results may be…”; “‘The assumptions we make…”; “‘Broadly, we assumed
that around 60% of patients in the CBT group would have a ‘positive outcome’ at one year follow‐up…”; “We
speculated that….” (see Appendix I).
Inadequate sub‐grouping of trial cohort
There is now an unmistakable recognition that sound biomedical research has strengthened the need for
subgrouping of “CFS” and for many years, international experts have been calling for such sub‐grouping
(http://www.meactionuk.org.uk/Subgroups.htm). A document dated 8 th February 2003 was sent to the MRC
(Information for the MRC “CFS/ME” Research Advisory Group by Hooper and Williams) which pointed out
the need for subgrouping and which quoted Dr Derek Pheby’s Discussion Document of February 1999 that
was prepared for the Chief Medical Officer’s Working Group to consider. In that document, Pheby (then at
the Unit of Applied Epidemiology, Frenchay Campus, Bristol) was unequivocal about the need for attention
to be given to the existence of subgroups and he quoted from the 1994 Report of the UK National Task Force
on CFS / PVFS / ME, which states: “Although both the terms “CFS” and “ME” have a range of applications,
they do not represent the same populations”.
In his document for the CMO’s Working Group Pheby stated:
• “The National Task Force recommended that five main sets of issues should be addressed, i.e. Clarify the
difference between the various chronic fatigue syndromes… areas where in the view of the Task Force
research needed to be encouraged included: clear definition of the various chronic fatigue syndromes”
• “ CFS is a spectrum of disease” (quoting Levine), who is emphatic: “It is clear that CFS is not a single
entity”
• “Variations in prognosis may be attributable once again to the heterogeneity of the condition, with different
subgroups having different prognoses”
• “The heterogeneity of CFS has made it very difficult to interpret research results from different
studies which may have been conducted in very dissimilar populations”
• “If progress is to be made, it is necessary to consider…the existence of subgroups within the
population of patients with CFS / ME”
• “The increasing knowledge of pathological processes occurring in CFS / ME has led to a belief that
it should be possible to define subgroups on the basis of biomarkers and thus to draw a distinction
between CFS and ME”.
Fifteen years later, the Wessely School still refuse to accept the need for subgrouping within the broad
“CFS” construct and insist that all states of “medically unexplained fatigue” should be amalgamated. This is
contrary to the basic principle of scientific exactitude, yet the MRC, the bastion of scientific exactitude,
apparently sees no problem.