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

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246<br />

Clearly, therefore, the Oxford criteria do not identify patients with <strong>ME</strong>, yet the Wessely School and the MRC<br />

<strong>in</strong>sist otherwise.<br />

On 16 th June 2005, Sarah Perk<strong>in</strong>s, Programme Manager, MRC Neurosciences and Mental Health Board,<br />

confirmed: “The ma<strong>in</strong> entry criteria for the PACE Trial are the Oxford criteria…the exclusion criteria of ‘proven<br />

organic bra<strong>in</strong> disease’ will be used to exclude neurological conditions of established anatomical pathology such as<br />

Park<strong>in</strong>son’s disease and multiple sclerosis. It will not be used to exclude patients with a diagnosis of <strong>ME</strong>”.<br />

Given that the Oxford criteria expressly exclude those with organic bra<strong>in</strong> disease and that the WHO<br />

classifies <strong>ME</strong> as a neurological organic disease under Disorders of Bra<strong>in</strong>, Sarah Perk<strong>in</strong>s was asked why the<br />

MRC was adopt<strong>in</strong>g special plead<strong>in</strong>g <strong>in</strong> relation to <strong>ME</strong>, and on what scientific evidence‐base the MRC was<br />

rely<strong>in</strong>g to enable it to disregard the ICD‐10 classification that had been approved by the World Health<br />

Assembly.<br />

Furthermore, given that the Wessely School psychiatrists demand 100% proof of organic pathoaetiology for<br />

<strong>ME</strong> before they will “allow” it to be accepted as a “real” organic disease as dist<strong>in</strong>ct from a mental disorder,<br />

she was also asked why the MRC does not equally require a similar standard of proof from the Wessely<br />

School that <strong>ME</strong> is <strong>in</strong>deed a mental disorder as they assert.<br />

She did not reply.<br />

Despite their <strong>in</strong>sistence that they are study<strong>in</strong>g people with “CFS/<strong>ME</strong>”, the Wessely School do not accept<br />

that <strong>ME</strong> is a neurological disorder, so it is unlikely that an assessment which would identify the relevant<br />

signs and markers of <strong>ME</strong> would be carried out on PACE Trial subjects.<br />

Without such an assessment it is not possible to be confident that people with <strong>ME</strong> have been screened out,<br />

so the possibility rema<strong>in</strong>s that some participants recruited to the PACE behavioural research trial actually<br />

have <strong>ME</strong>, which may mean that at least some participants have a disorder that contra‐<strong>in</strong>dicates the<br />

<strong>in</strong>terventions concerned.<br />

If there is no strict adherence to the entry criteria, then the results will be flawed from the outset ‐‐ either<br />

the criteria are adhered to, or the results will be flawed: there is no other scientifically credible<br />

<strong>in</strong>terpretation.<br />

The CDC criteria<br />

As noted above, one of the PACE Trial Pr<strong>in</strong>cipal <strong>Invest</strong>igators (Michael Sharpe) was a co‐author of the 1994<br />

CDC (Fukuda) criteria and, as a member of the International CFS Study Group who advised the authors,<br />

Simon Wessely was also <strong>in</strong>volved, and they successfully <strong>in</strong>corporated elements of the Wessely School’s<br />

model of “CFS” <strong>in</strong>to the CDC 1994 def<strong>in</strong>ition.<br />

The 1994 CDC criteria do not stipulate the presence of the card<strong>in</strong>al feature of <strong>ME</strong>, which is post‐exertional<br />

malaise (it is optional) As a result, the 1994 CDC def<strong>in</strong>ition does not identify people with <strong>ME</strong> as dist<strong>in</strong>ct<br />

from those with psychiatric fatigue because it <strong>in</strong>cludes people with psychiatric disorders; moreover, the<br />

1994 CDC def<strong>in</strong>ition dropped all physical signs, but physical signs are always present <strong>in</strong> <strong>ME</strong> (see Section 2<br />

above).<br />

The “London” criteria<br />

In apparent response to public disquiet about the use of the Oxford criteria for entry, it was confirmed by<br />

the MRC that there was to be an additional “secondary analysis” of the data us<strong>in</strong>g the “London criteria”, but<br />

there is no mention of any “secondary analysis” us<strong>in</strong>g the “London criteria” <strong>in</strong> the orig<strong>in</strong>al Trial Identifier.

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