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

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The PIs’ statement is interesting because there is a significant difference between subgrouping according to
symptoms and stratifying according to different case definitions – it would be impossible to subgroup on
the basis of case definition because the categories are not discrete (ie. there is too much overlap).
The PIs’ statement is even more interesting in the light of the documented chronology:
• in September 2002 Peter White submitted the first application to the West Midlands MREC, date
stamped 12 th September 2002. The Oxford criteria are mentioned in the application
• in March 2003 Peter White submitted a revised application date stamped 21 st March 2003, which
included the Oxford criteria, Dr Ramsay’s description of ME, the 1994 CDC Fukuda criteria, but not
the London criteria
• the Trial Identifier was also included in that bundle and it states: “We will also examine whether CDC
or ‘ME’ criteria define response”
• it can thus be said that from (at latest) 21 st March 2003 Peter White intended to use Ramsay’s
definition of ME, as demonstrated by the written approval of West Midlands MREC
• the first mention of the London criteria in the MREC literature appears two months later:
“Substantial Amendment 2.1, 22.10.2004: We have made some minor changes to the protocol…to
ensure we are measuring predictors…that patient organisations believe are important (London
criteria for myalgic encephalomyelitis)” (emphasis added)
• thus sometime between March 2003 and October 2004 the PIs decided to abandon the Ramsay
definition of ME and to adopt a version of the “London” criteria following insistence from someone
connected with AfME
• in contrast to the Ramsay definition, AfME’s attenuated version of the proposed “London” criteria
set out in the Full Protocol does not require the presence of any neurological disturbance for a
diagnosis of ME, which would lessen the distinction between true ME and “medically unexplained
fatigue” (a somatisation disorder).
The intention to use the outcome of the PACE Trial to inform a revision of the NICE Guideline
Referring to a future revision of the NICE Guideline (CG53), the PACE Participants’ Newsletter Issue 3 of
December 2008 robustly forecast that the outcome of the PACE Trial “will enrich the guidelines in 2009”. This
is curious, given that the same Newsletter states on the same page: “We will be very busy analysing the main
results of the trial in the spring of 2010”, so it is unclear by what transparent process the unpublished PACE
Trial results will inform the forthcoming revision of CG53 that the PACE Participants’ Newsletter says is to
take place one year before the PACE Trial results are to be published.
The pronouncement may, however, be taken to support the belief of the ME/CFS community that the
outcome of the PACE Trial is – as was the outcome of the NICE Guideline on “CFS/ME” – a foregone
conclusion.
For the avoidance of doubt, the PACE Participants’ Newsletter was incorrect. A Written Answer to a
Parliamentary Question tabled by the Countess of Mar states: “The National Institute for Health and Clinical
Excellence will consider in August 2010 whether there is a need to review its clinical guideline on Chronic fatigue
syndrome / myalgic encephalomyelitis” (Hansard: Lords: 5 th May 2009).