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

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a) emotional lability….b)…difficulty finding the right word c) disturbed sleep patterns d) … a feeling of imbalance
e) tinnitus [ringing in the ears]
3. Fluctuation of symptoms usually precipitated by either physical or mental exercise. [NB The usual precipitation
by ‘physical or mental exercise’ should be recorded but is not necessary to meet criteria]
4. These symptoms should have been present for at least 6 months and should be ongoing
5. There is no primary depressive illness or anxiety disorder/neurosis. [NB This means that if any depressive or
anxiety disorder is present, the London criteria are not met]”.
The criteria were to be judged by the Research Nurse, who was advised that psychiatric exclusions are
schizophrenia, bipolar illness, substance misuse, eating disorder, and proven organic brain disease;
however, the RN was specifically advised that “Other psychiatric disorders (including depressive illness, anxiety
disorders, and hyperventilation syndrome) are not reasons for exclusion”.
Criterion 1 and criterion 3 appear to be mutually exclusive. Furthermore, if criteria a‐e are unnecessary for a
diagnosis of ME by the PI’s London criteria, all that is left is the Oxford criteria with no requirement for
neurological symptoms (but with the absence of depression or anxiety as assessed by the Research Nurse,
which does not exclude assessor bias). Dowsett & Ramsay stipulated that neurological disturbance must be
present, yet the PIs state in their criterion 2 that neurological disturbances are not necessary to make a
diagnosis.
What is left is an entirely inadequate description of the neurological disease ME and does not further the
delineation of scientifically meaningful subgroups.
In the 2005 empirical definition by William Reeves et al from the US, CFS is described demeaningly as
“chronic un‐wellness”(BMC Med 2005:3:19), about which Peter White stated in the Trial Identifier at Section
3.6: “The more narrowly defined CDC criteria (ie. the 1994 Fukuda criteria) are about to be…superseded by an
empirically derived definition [and] PDW is a member of the CDC led group”, thus endorsing the term “chronic un‐
wellness” as an acceptable description of ME/CFS.
This is all the more disturbing given that on 31 st March 2003 the West Midlands Multi‐centre Research Ethics
Committee wrote to Peter White about “THE FINAL DOCUMENTS AND ARRANAGEMENTS APPROVED
BY THE MREC”, saying: “The documents that have now been approved are as follows”; item 8 on that list is a
date‐stamped copy of “Dr Melvin Ramsay’s description of myalgic encephalomyelitis” (marked “RECEIVED 21
MAR 2003”). A scanned copy of the Ramsay definition that was approved by the MREC is attached as
Appendix III to this Report.
Two years later, however, by letter dated 2 nd February 2005 the West Midlands MREC acknowledged Peter
White’s letter to them received on 7 th January 2005, saying: “It is noted that this is a modification of an
amendment previously rejected by the Committee”. The list of approved documents no longer contains Dr
Ramsay’s definition of ME but does list “London criteria for ME”.
It is beyond doubt that symptoms necessary to comply with Ramsay‐defined ME do not feature in the PACE
Trial and are not included in the version of the “London” criteria as set out on page 188 of the Full Protocol.
It appears that the “London” criteria were substituted for the Ramsay definition and that the PACE Trial
version of the “London” criteria does not require the presence of neurological disturbance (which is a
cardinal requirement in Ramsay’s definition).
In the ME Association’s magazine “ME Essential”, October 2004, the three PACE Trial Principal
Investigators responded to the criticisms of the trial that had been published in “ME Essential” in July 2004;
the PIs stated: “”We note the ME Essential article supports the use of the Oxford criteria and not using the Canadian
criteria for CFS/ME, as the former are most inclusive and will allow us to see if different subgroups (for example those
who meet the criteria for ME) respond differently to the treatments…We welcome the endorsement of the inclusion of
the London criteria for ME as a possible predictor of response to treatment”.