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

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such as multiple sclerosis in which fatigue is a major feature, so their purloining of just one classified
neurological disorder (ME) is particularly notable.
One of the MRC PACE Trial Principal Investigators (Michael Sharpe) and the person who will oversee the
PACE Clinical Trial Unit (Simon Wessely) were involved in the formulation of the Fukuda et al CDC 1994
criteria: Sharpe was a co‐author and Wessely was a member of the “International Chronic Fatigue Syndrome
Study Group”, and they successfully incorporated elements of the Wessely School beliefs into the CDC 1994
definition. For example:
“We dropped all physical signs from our inclusion criteria”
“Whether to retain any symptom other than chronic fatigue generated the most disagreement among the
authors”
“We did not use other psychiatric disorders, such as anxiety and less severe forms of depression, as a basis
for exclusion…..The exclusion of persons with these conditions would substantially hinder efforts to clarify
the role that psychiatric disorders have in fatiguing illness” (Ann Intern Med 1994:121:12:953‐959).
This means, of course, that the CDC 1994 criteria do not specifically identify those with ME and they lend
legitimacy to the hijacking of the term “CFS” by the Wessely School to include those with non‐organic
fatigue.
Recruitment to the PACE Trial
It is enlightening to note the tactics used to secure patient recruitment and to retain their participation, about
which the Institute of Psychiatry’s Clinical Trials Unit document “Patient Recruitment” (accessible on the
IoP’s website) is informative:
“Patient recruitment is …one aspect of a trial that we cannot easily control. Active participation of
consumers/users/clients/patients, whatever one chooses to call them, is vital if any clinical trial is to be brought to a
successful conclusion”.
The IoP CTU document draws attention to various bodies that have been set up specifically to develop
“strategic alliances” with key groups in order to promote greater involvement in clinical trials and it notes:
“Consumers can help with recruitment of their peers” and that they can “disseminate the results…to ensure that
changes are implemented”, observing that “The involvement of consumers is now becoming an increasingly
political priority”.
The IoP’s CTU “Recruitment Checklist for Large Clinical Trials” includes the following:
“At the protocol and funding stage:
• Choose a good acronym
• Budget for marketing costs, such as newsletters, headed notepaper etc
• Develop partnerships with consumer groups
“At the start‐up and recruitment stage:
• Choose a striking logo, and put it onto letterheads and all trial materials
• Write articles for medical journals and consumer conferences
• Present papers and posters at relevant conferences
• Provide user‐friendly, attractive and stylish trial materials