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

277
consent requires that the participant be given information adequate to making a reasonable decision as to
whether to take part in the research or not. Where the information is less than all that is relevant, then the
participant does not have adequate control of the risk”, failure of which will in general “be prima facie
ethically unacceptable”.
Whilst not specifically related to ME or the MRC PACE Trial, an article in the Guardian on 18 th September
2009 by Sarah Bosely on “dubious research practices” quotes Jane O’Brien, Head of Standards and Ethics at the
General Medical Council (GMC) as saying that the GMC disapproves of misleading people about the
credibility of research. The article says: “(Jane O’Brien) added that the GMC felt it important to play a role in
ensuring good conduct in research. About a year ago, she said, they took soundings of bodies that regulate and
support research, such as the Medical Research Council, asking whether the GMC should be involved. ‘The response
was yes, because we are the people who can strike doctors off in the end’ ”.
In the light of such confirmation, the GMC may be asked to investigate the PACE Trial, since “good
conduct in research” seems to be singularly lacking in this particular MRC trial.
The MRC Good Research Practice (second edition, September 2005) recommends on page 2 that the 1995
Nolan Committee on Standards in Public Life that requires adherence to seven principles (selflessness,
integrity, objectivity, accountability, openness, honesty and leadership) provides a good starting point. It
seems that the MRC PACE Trial Investigators may have failed on several of those counts.
Furthermore, given that clinicians had to be tempted by financial rewards to refer patients into the PACE
and FINE Trials (see Section 3 above), it may be postulated that the trials are of concern on that count also. It
is the case that the companion FINE Trial Patient Information Sheet assures patients that “Your GP is not
being paid for his or her participation in this trial”, but there is a different message for GPs, because the GP
invitation letter states: “(GP) Practices will be recompensed by the Department of Health for time spent in
identifying and recruiting patients (£26.27 per referral)”. This would seem to be an example of outright
misrepresentation regarding these trials.
9. So that participants should not think that the therapists believe “CFS/ME” to be a behavioural disorder,
CBT and GET are portrayed in the PACE Trial literature as successful “treatments” that have been used
effectively in other “physical” diseases such as cancer. That this is untrue in relation to cancer has been
confirmed in writing by a major UK cancer charity (Cancer Research UK) on 6 th December 2008 (personal
communication).
Furthermore, at the 2008 British Psychological Society meeting in Dublin, during the oncology session it was
confirmed that only about one in ten people with cancer are offered CBT, and then only if they are
distressed and really struggling to adjust. Importantly, CBT is offered only after all biomedical testing has
been completed and the diagnosis confirmed. Offering CBT before then was shown to be
counterproductive and unhelpful, yet this is exactly what is happening in ME/CFS.
It is notable that in October 2009 Dutch psychologists reported that in relation to cancer patients undergoing
chemotherapy: “the suggestion that physical exercise reduces fatigue is not proven”. They further pointed out that:
“In the past, several studies have refuted the hypothesis that improving physical condition, or increasing physical
activity, leads to a reduction in fatigue. In fact, the two exercise studies in breast cancer patients cited by Adamson et
al (2009) observed…no improvement in fatigue” (http://www.bmj.com/cgi/eletters/339/oct13_1/b3410#224003 ).
10. The special interest of the DWP in the PACE Trial was not made sufficiently clear to participants (ie. the
importance of the PACE Trial to the DWP was not mentioned, nor the fact that this is the only clinical trial
that the DWP has ever funded, information that potential participants entering a “clinical” trial might have
wished to be aware).