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

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(13) The Investigators may have introduced bias by overtly favouring the CBT and GET arms of the trial by
telling participants receiving these interventions that they can be curative, thereby invoking the placebo
response and putting subtle pressure on those participants to report a positive outcome.
(14) The Investigators may not have achieved the required clinical equipoise of the trial because they have
already formed their opinion that “CFS/ME” is psychogenic.
In clinical trials, there is an ethical requirement for equipoise, defined as “the point where there is no preference
between treatments, i.e. it is thought equally likely that treatment A or B will turn out to be superior” (RJ Lilford et
al. JRSM 1995:88:552‐559). The Trial Protocol cites Lilford et al and moreover it states: “those recruiting and
randomising participants will rigorously maintain a position of equipoise and employ explanations that are consistent
with this. All the participating clinicians regard all four treatments as potentially effective”. However, it is evident
that not all the participating clinicians believe all four treatments to be potentially effective, as the Manuals
state that CBT and GET are potentially curative, whereas no similar claim is made for APT or SSMC.
Furthermore, as stated above, Peter White and Trudie Chalder resigned from the CMO’s Working Group
Report because it supported the use of pacing. Is it ethical for the PIs to be responsible for a trial of pacing
when they do not believe in it and even believe it has the potential to harm patients by maintaining them in
a state of deconditioning and psychological dependency (ie. it “may improve symptoms, but at the expense of
disability”—Trial Identifier Section 2.3).
Lilford et al are clear:
“Members of ethics committees should proceed on the basis that the question to be investigated has not
already been answered. In some cases…the ‘experts’ (however defined) may all be in agreement as to which
treatment is best. Under these circumstances the trial would be unethical.
“Just whose views are worthy of respect (and thus may be considered ‘expert’) may be a matter of some
controversy…It cannot be assumed that (experts’) strength of belief will always correspond to the strength
of the evidence”.
On this basis alone the PACE Trial seems to be unethical, because there is known agreement between the
three PIs (and Wessely) that CBT and GET are superior to pacing (APT) and to SSMC.
Lilford et al further state:
“…the public might become suspicious and resentful if clinicians fail to disclose personal preferences in the interest
of…convincing other clinicians”.
Given the known and published views of the PIs and of Wessely, how can the PACE trial claim to have
fulfilled the standard of equipoise described by Lilford et al and cited by the PIs when, from the outset, their
own firmly‐held views may have weighted the trial in favour of their preferred interventions?
In 1976, the current co‐leader of the Oxford PACE Trial Centre, Professor Tim Peto, said about clinical
equipoise:
“Physicians who are convinced that one treatment is better than another for a particular patient of theirs
cannot ethically choose at random which treatment to give: they must do what they think best for the
particular patient. For this reason, physicians who feel they already know the answer cannot enter their
patients into a trial. If they think…that they know the answer before the trial starts, they should not enter
any patients…” (Clinical Equipoise and RCT design. www.uab.edu/ethicscenter/weijer.ppt).
This, however, is precisely what the Principal Investigators are doing with the PACE Trial.