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

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only one database. This will be held securely at St Bartholomew’s Hospital, in London, and it will be used only to
monitor recruitment. You will not be named in any published study results from our study”.
However, the leaflet also said: “occasionally, other researchers will need to see your notes so that they can audit the
quality of our work. An audit might be run by one of the universities helping with our study or hospital regulatory
authorities, or by one of the organisations funding our study”.
As already noted, funders are the Medical Research Council; the Scottish Chief Scientist’s Office; the
Department of Health and the Department for Work and Pensions.
The leaflet says that participants are to be questioned about how “CFS/ME” has affected them financially,
which for patients on DWP State benefits may be a cause for concern, especially as the DWP has the right to
access this data and it is widely believed that the intention is to remove as many people as possible from
State benefits.
If the PACE trial therapists and Investigators deem a participant “recovered” enough to resume work, then
might that participant quickly discover that the DWP has stopped paying benefit? The MRC PACE Trial has
been described as a “Trojan horse” for the DWP.
Was it made clear to all participants (some of whom may be cognitively impaired) that, as co‐funder of the
PACE Trial, the DWP would have access to their personal clinical notes? Would participants have been
willing to sign up for the PACE Trial if so?
Furthermore, if State benefits are withdrawn from PACE Trial participants, this would serve as “proof” that
the Wessely School’s programme of CBT/GET is effective and ‐‐ to the detriment of genuine ME/CFS
patients – the Wessely School’s psychosocial interventions will be further rolled out across the nation, as
seems to be intended.
When the PACE Trial had been running for two years, the Participants’ newsletter (Issue 1, June 2006)
reaffirmed that the trial data was safe:
“The information is being entered onto a large and secure database, designed and maintained by an independent
clinical trial unit at King’s College, London”.
This seems to conflict with the “Invitation to join the PACE Trial” leaflet (see above), which states that the
data will be held securely at St Bartholomew’s Hospital.
Concerning confidentiality, participants who asked: “Will you keep my details confidential?” were to be told:
“Yes. All your details and all recordings will be kept strictly confidential and held in a locked filing cabinet or on a
secure computer” (SSMC Participant Information Sheet for PACE Trial).
Failure of PACE Trial Investigators to ensure confidentiality (theft of data)
Assurance of confidentiality may, however, be a meaningless promise. It was in 2005 (ie. during the life of
the PACE trial) that one of the PACE Trial Principal Investigators, Professor Michael Sharpe, inadvertently
leaked a computer file containing a confidential list of over 70 patients’ names and addresses which he sent
to a member of the public, who unknowingly forwarded the information to other people.
Most of the named patients, some of whom live in sheltered accommodation, can be – and have been ‐‐
identified.