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

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of 600 participants. Issue 3 of December 2008 states that numbers of recruits had still not reached the target,
so the MRC had granted the Trial team further funding to allow them to continue recruiting until November
2008 to enable them to achieve their target of 600 participants. The PACE Trial Participants’ Newsletter Issue
3 said that because there was a problem with recruiting participants, as well as being granted more money
by the MRC and more time to achieve the set recruitment levels, it had been decided that an additional Trial
Centre should be opened at Frenchay Hospital, Bristol (which had begun recruiting in April 2007).
There was undoubtedly a problem with recruitment and the Minutes of the PACE Trial Steering Committee
held on 22 nd April 2004 record that recruitment estimates “need to be reviewed. It was particularly noted that
it may be worth training the clinicians who would be recruiting patients into the trial in recruitment
strategies and procedures” and that “The protocol will be amended accordingly. These include: Consider
training participant recruiters”.
On 12 th May 2004 the Parliamentary Under Secretary of State at the Department of Health, Dr Stephen
Ladyman, announced at an All Party Parliamentary Group on Fibromyalgia (FM) that doctors were being
offered financial inducements to persuade patients with FM to attend a “CFS” Clinic to aid recruitment to
the PACE Trial. For achievement of the recruitment target to have to depend on financial inducements to
clinicians in order to persuade patients who do not suffer from ME/CFS to enter the PACE Trial would
seem to indicate that something is seriously wrong with the trial.
With the aim of improving “generalisation of our results to a larger number of patients” as well as
improving recruitment, by letter dated 9 th February 2006 to the West Midland MREC, Peter White
requested changes to the eligibility and primary outcome criteria. He sought permission to change the SF‐
36 threshold for inclusion (the Investigators were having to turn away patients because they were too well)
and he sought permission to include patients who had previously received CBT/GET at non‐PACE Trial
centres. What the consequences of allowing an unspecified number of people who had previously
received CBT/GET to join the PACE Trial might be was not clarified.
By letter dated 14 th July 2006 to the West Midlands MREC, Peter White requested permission to advertise
(his word) the PACE Trial to GPs. The Investigators were really struggling to recruit participants so decided
to recruit patients direct from primary care. The wording of the advertisement to GPs is interesting: “If you
have a patient with definite or probable CFS/ME, whose main complaint is fatigue (or a synonym), please consider
referring them to one of the PACE Trial centres”. Just how scientifically rigorous the inclusion of patients
with “fatigue (or a synonym)” might be is a matter for speculation.
Quite certainly, such broad canvassing has resulted in someone who had shingles (herpes zoster) being
included in the PACE Trial on “CFS/ME”: since the Oxford criteria catch anyone who is chronically
“fatigued”, people with post‐herpetic tiredness are known to be included in the PACE Trial, even though
herpes zoster is not the same disorder as ME/CFS. Such lack of exactitude means that the results of the
PACE Trial could be meaningless.
The PACE Participants’ Newsletter (Issue 2, March 2007) was openly soliciting for more participants: “If you
know of any friends or family who suffer from CFS/ME and who might be eligible and interested in taking part in the
study and live close enough to one of these centres, please suggest they approach their GP for a referral to a PACE
centre”. The problems with using existing participants to recruit new participants are obvious.
First, the existing participant might no longer feel inclined to report negative effects and might exaggerate
any positive effects because (i) they may feel they have become part of the PACE research team and thus feel
a loyalty that could influence how they report their experience and (ii) participants who recruit others are
asking them to join in their own experience and thus they assume a burden of responsibility, as a result of
which they may be less likely to report ‘it was awful’ or ‘ it did not help’. This could render their own
subjective data invalid. Furthermore, if a participant knows s/he has persuaded someone else to join the