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

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Are the researchers claiming that an “expert” would check the work of every therapist in every session in
every PACE Trial Centre?
Is this deemed necessary because there is concern about the calibre of the therapists recruited and employed
for the PACE Trial? It is known from Peter White himself that there were serious difficulties in procuring
enough therapists (see Section 2 above).
If so, is delivery of psychotherapy by such people to PACE Trial participants justifiable, especially as the
Department of Health is a co‐funder of the PACE Trial and its own Research Governance Framework for
Health and Social Care states at section 3.1.2:
“All those involved in research also have a duty to ensure that they and those they manage are appropriately qualified,
both by education and experience, for the role they play in relation to any research”.
It seems much more to do with the MRC’s concern about indemnity, as recorded in the Minutes of the Joint
Trial Steering Group and Data Monitoring and Ethics Committee meeting held on 24 th September 2007:
“Action 18: Julia DeCesare to reference MRC GCP (Good Clinical Practice) Guideline (1998) in section 17, and to
add in information on indemnity as provided through NHS R&D (Research & Development). Action 19: Robin
Buckle to check under the new MRC sponsorship agreement what indemnity the MRC can offer”.
This seems to relate to protection for those running the MRC Trial, not protection for participants. The MRC
website states:
“MRC will provide indemnity in the case of negligent harm for research conducted through its
Units when it is Sponsor and for employees or others acting on behalf of the Council… The
MRC when acting as Sponsor, in some circumstances, may be prepared to offer, on a voluntary
basis, an ex‐gratia payment in the event of non‐negligent harm”.
“Multi‐Centre Research. This is more complicated as, even when the MRC is Sponsor, MRC
indemnity should not cover responsibilities of other organisations. If MRC is Sponsor but research
takes place at other sites (e.g. NHS hospitals or Universities) then appropriate arrangements should
be put in place i.e. the employers of the researchers at each site accept insurance or
indemnity liability for their employees” (the main sponsor for the PACE Trial is Barts and
The London Queen Mary School of Medicine and Dentistry – Full Protocol, page 15).
Severe Adverse Events (SAEs).
The Minutes of the PACE Trial Steering Committee held on 22 nd April 2004 record:
“It was noted the (sic) severe adverse events (e.g. a patient having a stroke) was not necessarily severe adverse reaction
(SAR) to treatment. Therefore the procedure for notifying everyone of severe adverse reactions did not apply to all
severe adverse events. The definition of SARs in this trial is complex and requires further consideration”.
Given the extensive literature on vascular and inflammatory problems in ME/CFS and the documented
increased risk of cardiovascular events in relation to exercise for people with ME/CFS, such a dismissal
seems cavalier to say the least.
It is notable that on 27 th February 2007 in his annual Report for the PACE Trial to the West Midlands MREC,
Professor Peter White informed MREC that of the actual number of participants recruited to that date (222),
there had been 21 serious adverse events (which at about 10% is quite a high figure).