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

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believe it was because there would be no objective evidence of improvement shown by the Actiwatch
sensors, a finding that would be inconvenient to the Investigators, therefore no objective data were to be
collected), computers and software, heart rate monitors, stop watches, 18 audio machines and 3,150
audiotapes (£36,360.00); Staff Travel (£64,880.00), and Consumables, (£218,635.00); this figure includes
Action for ME’s consultancy costs of £4,312.00. The NHS component consisted of the cost of therapists.
When recruitment to the trial proved to be such a problem, an additional amount of £702,975.00 was granted
by the MRC (MRC PACE Trial extension 2009‐2010).
Cost effectiveness of CBT and GET
In terms of the cost‐effectiveness of CBT, when NICE was considering the cost‐benefit ratio it discovered
that there are only two studies that have considered the cost effectiveness of CBT. One was a study by
Wessely et al (BJGP 2001:51:15‐18). It showed no benefit from CBT.
The other was the Severens/Prins et al study (Q J Med 2004:97(3):153‐161) that was based on the Prins et al
2001 study of CBT for CFS (Lancet 2001:357:9259:841‐847).
Not only did the Prins et al study not include patients with ME/CFS (Prins et al used their own case
definition – a modified version of the CDC 1994 definition – which essentially identified patients with
idiopathic chronic fatigue, so no conclusions can logically be drawn from it regarding ME/CFS patients), in
this single study that NICE could find upon which to rely for its costing of the alleged effectiveness of CBT
(Severens et al), the original authors (Prins et al, 2001) admitted flaws which included (i) the self‐selection of
participants (ii) high drop‐out rate for unrecorded reasons (up to 40%), and (iii) a bias between the control
group and patients in the treatment arm subjected to CBT.
Furthermore, NICE concluded that this single paper upon which its entire costing analysis relied had under‐
reported the benefits of CBT because the timescale used by the Dutch authors was insufficient to show long‐
term benefits (the authors’ treatment timescale was only eight months and the follow‐up was six months,
making only 14 months in total).
NICE therefore decided to “extend” the timescale to fit its own requirements to show long‐term benefits of
CBT. Since there was no evidence in the Severens et al study, NICE decided to use the 2001 study by Deale,
Wessely et al (which was a five‐year follow‐up of their 1997 paper), from which NICE extrapolated Deale et
al’s results from data that the authors themselves recognised was corrupted because of multiple further
interventions during the study period), and projected those results into the Severens et al study to produce
what might have been Severens’ results in five years’ time.
It should be noted that the two studies used different case definitions and different entry criteria, so NICE’s
contrived “evidence” is simply conjecture, yet NICE asserts it is the “best evidence available”.
To base a national Guideline on such speculation is hardly the standard of excellence that NICE is expected
to provide.
In terms of cost‐effectiveness of GET, there is no evidence at all. The single study which attempted to
demonstrate that GET is more (or indeed less) effective than CBT was unable to show any difference
between CBT and GET (McCrone P et al. Psychological Medicine 2004:34:991‐999).
For the PACE Trial Investigators to advise that CBT/GET is cost effective for ME/CFS is entirely unproven,
yet in the Trial Identifier Peter White confidently states: “The results of this trial will allow health planners,
clinicians and patients to choose treatment on the basis of both efficacy and cost” (Section 2.5).