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

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before it was completed. If some participants’ subjective observations are part of the data for the trial, then
that data might be deemed not to meet the requirements of proper MRC research practice.
By providing such glowing praise about the PACE Trial to other participants indirectly but improperly
makes it less likely that the people who wrote it would dare to disagree with what appears to be a
substantial weight of opinion, especially as some of it came from a doctor.
This tactic could be construed at best as unduly influencing participants (because the PACE Newsletters all
bear the logos of the MRC, the Scottish Chief Scientist’s Office, the Department of Health and the
Department for Work and Pensions, which imbues the Newsletters with kudos and authority, suggesting
that the contents are reliable and of the highest standard) and at worst as a political strategy that has no
place in medical research.
The point of an RCT is to try to factor out any uncontrollable influence that may affect the results, but in this
case the PACE Trial Investigators have actually brought in an influence for which they cannot control. That
is bad science.
The study designers believe that “CFS/ME” is a psychosocial disorder that is susceptible to positive
thinking, and it seems that they have used psychological cajoling strategies such as “let’s all get better with
the PACE Trial”, which may have been designed to make recovery seem trendy and socially attractive.
Researchers have a responsibility not to harm participants, but if a PACE Trial participant found that s/he
was not improving, on reading such favourable comments from other participants, they might feel that their
lack of improvement was their own failure, especially as participants in the CBT and GET arms of the Trial
are informed throughout their own Manuals that – without qualification – recovery is possible with
CBT/GET.
When participants are recruited from a patient population known to have suffered stigma and
marginalisation, such tactics are not something that responsible researchers would want to risk without
ethical approval. Was ethical approval for this obvious strategy sought or approved?
The MRC’s Public Relations (PR) Strategy
The question to be asked is: what kind of clinical trial needs a PR (public relations) strategy?
The Minutes of the Trial Steering Committee meeting held on 22 nd April 2004 record:
“The need for active public relations strategy that involved the Principal Investigators, the Trial Management Group,
MRC and Action for ME was strongly endorsed. The Trial Steering Committee suggested that the PR (public
relations) policy for potential and actual participants was particularly important. It was also agreed that there
needed to be a specific working group to plan the public relation strategy and that this would have the
following elements: Positive public education and information about the trial (and) the correction of
disinformation being circulated about the trial. It was agreed that the Principal Investigators would meet
with the MRC and Action for ME to develop a media strategy”.
This documented need for such a PR strategy indicates that those involved with the PACE Trial were fully
aware of the level of public disquiet about the Trial.
Of particular note is the letter dated 15 th September 2004 from Rhiannon Powell of Chandler Chicco Agency
(a PR and lobbying firm) to Mansel Aylward (then Chief Medical Advisor to the Department for Work and