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

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Peter White, however, asserted that all were “definitely unrelated” to the study treatment. This statement is
curious, because of the 21 people who experienced a severe adverse event, it appears that at least 13 chose to
continue with the trial.
Peter White informed the West Midlands MREC that 80 participants had completed the trial to that date,
and that there had been eight withdrawals from the trial, six of which were self‐withdrawals and two were
for non‐compliance.
If the 8 withdrawals were from the 80 participants who had completed the trial, that is a 10% withdrawal
rate up to February 2007.
This hardly accords with the Minutes of the Forward‐ME Group of 8 th July 2009, which record that Sir Peter
Spencer, CEO of Action for ME, said:
“AfME was associated with PACE and had been pleased with the very low drop‐out rates”.
Predictors of Outcome of the PACE Trial
Under “Predictors of outcome” in the Trial Identifier, the Principal Investigators state with conviction:
“Previously found predictors of a negative outcome with treatment include mood disorder, membership of a self‐help
group, being in receipt of a disability pension, focusing on physical symptoms, and pervasive inactivity”.
No mention is made of the severity of physical illness or of serious and demonstrable organic pathology as
predictors of a negative outcome to the Wessely School’s own brand of cognitive restructuring.
Outcome measures were discussed at the First Meeting of the Trial Steering Committee held on 22 nd April
2004 at St Bartholomew’s Hospital, London.
The Minutes record:
“The outcome measures were discussed. It was noted that there may need to be an adjustment of the threshold
needed for entry to ensure improvements were more than trivial” (emphasis added). This appears to indicate
concern that any improvement might be minor and not statistically significant, a result that might be
unacceptable to the Investigators.
Outcome measures were discussed again at the Joint Trial Steering Committee and Data Monitoring and
Ethics Committee meeting held on 27 th September 2004 and the Minutes record:
“Professor White led discussions on the outcomes, and the Trial Management Group’s struggle to find an
objective outcome measure as requested by the Trial Steering Committee at their last meeting, particularly
as CFS/ME is a subjective condition.
“Professor Darbyshire led discussion about how to define ‘improvement’. The question was asked ‘how soon will you
know if a participant is getting worse?’ to which Professor Chalder responded that previous research has shown that it
cannot be determined if people are getting better (sic) until at least six months after the end of therapy (i.e. a year after
therapy has begun). CBT and GET may both make a patient worse before they begin to improve”.
The Minutes do not record an answer being given to the question that was asked, ie. “how soon will you know
if a patient is getting worse?”.