In The Expectation of Recovery

"In the Expectation of Recovery"
MISLEADING MEDICAL RESEARCH AND WELFARE REFORM
by George Faulkner
"In the
Expectation
of Recovery"
MISLEADING MEDICAL RESEARCH
AND WELFARE REFORM
by George Faulkner
Published by The Centre for Welfare Reform
Publishing Information
Recovery George Faulkner 2016
First published April 2016
"In the Expectation of Recovery" is published by the Centre for Welfare Reform
If you copy and reuse any part of the material in this report then you must always cite
both the author and the publisher and, whereever possible, provide a direct link to the
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64 pp
ISBN download: 978-1-907790-79-9
About the author:

George Faulkner is now an independent researcher who focuses on the political impact of problems
within medical research. This is not what he intended to become, and nor did he intend to write this
report. He was asked to briefly summarise concerns raised by others about the PACE trial, and explain
why these concerns were relevant to people interested in welfare reform. What was expected to be two
weeks of work led to three years of research and fact-checking, along with the grim realisation that
the problems in this area were so serious and widespread that that no-one could hope to explore them
comprehensively.
Acknowledgements:
While I take full responsibility for the fact checking and accuracy of this report, it is founded on the
work of others. As David Tuller says in the introduction to his recently published pieces on the PACE
trial, "much of what I report here will not be news to the patient and advocacy communities, which
have produced a voluminous online archive of critical commentary on the PACE trial". I do not know
who first raised many of the points highlighted in this report, so may not have given credit to those
who deserve it, but I hope that I have fairly and accurately presented the evidence in a way that does
justice to the work done by others.
Contents
Foreword. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
The Biopsychosocial Model . . . . . . . . . . . . . . . . . . . . . . . . . . 11
The responsibility to expect recovery. . . . . . . . . . . . . . . . . . . . . . . . . . 12
The PACE trial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
1. What is 'Chronic Fatigue Syndrome'? . . . . . . . . . . . . . . . . . . . . . . . 14
2. The problem with self-reported outcomes. . . . . . . . . . . . . . . . . . . . 15
3. The presentation of results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
The PACE trial's objective outcome measures . . . . . . . . . . . . . . . . . . . 16
Redefining 'recovery' . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
The Politics of Distorted Research . . . . . . . . . . . . . . . . . . . . . 22

Ongoing attempts to dismiss concerns and avoid releasing data . . . . 22
Conflicts of Interest. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Perverse incentives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Research Distorted by Politics . . . . . . . . . . . . . . . . . . . . . . . . 26

Cruel to be kind. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
The rise of the Biopsychosocial Model. . . . . . . . . . . . . . . . . . . . . . . . . 27
The power of the 'evidence-based' label. . . . . . . . . . . . . . . . . . . . . . . 28
Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Policy implications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Dangerous assumptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
1. Selected criteria from the PACE trial . . . . . . . . . . . . . . . . . . . . . . . . 35
2. Patient expectations and the danger of bias . . . . . . . . . . . . . . . . . . 39
3. Primary trial outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
4. Exaggerated positive claims. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5. Informed consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
6. Recent developments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
The Centre for Welfare Reform. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
A REPORT FROM THE CENTRE FOR WELFARE REFORM
"IN THE EXPECTATION OF RECOVERY" |
Foreword
by Simon Duffy, Director of the Centre for Welfare Reform
This is the world weve created for ourselves, a world where sick
and disabled people are now expected to recognise that the sick
role is temporary, in the expectation of recovery.
How things get twisted. In the past there was a rather patronising
attitude that of course we should provide disabled people with an
income, because they 'can't work'. Against this disabled people have
had to assert their desire and their right to work. What is more, they
have gone on to show the valuable role that disabled people can play as
workers and, more importantly, as citizens.
But what happens when politicians are desperate to cut benefits? What
happens when private insurance companies want to increase their
market share? What happens when people start to value research for
positive results rather than accuracy?
As George Faulkner explains, in this important report, it seems that
standards for academic research can easily drop out of sight when the
political and financial conditions are right. A treatment is hailed as a
great success, but pain and fatigue have been reclassified as recovery,
and now medical researchers fight to keep important information
from the public. Furthermore misleading medical research is disguised
behind layers of complex jargon and statistical manipulation. It takes
careful work to expose the array of falsehoods that lie hidden behind
the press releases, research papers and briefings.
Addressing the problems that George Faulkner outlines will take more
than a renewed sense of intellectual rigour and honesty by researchers.
More fundamentally we need to pay much more attention to our
basic human instinct to turn groups with little political power into
scapegoats for social problems that they clearly did not create.
I am honoured that independent researchers like George Faulkner
continue to use the Centre for Welfare Reform to publish and share
such important research. I hope that this research helps to further
strengthen the confidence of all those fighting injustice and resisting
the ongoing efforts to undermine the welfare state.
"IN THE EXPECTATION OF RECOVERY" | Summary
Summary
Recent government reforms to UK disability benefits have been
presented as an attempt to improve the lives and increase the
opportunities of disabled people, yet the available evidence indicates
that they have not been successful in this regard.
The 'biopsychosocial' model of disability has played an important
role in shaping these reforms, and is often portrayed as providing an
evidence based approach to the management and understanding of
disability.
This report will show how important claims about the value of
biopsychosocial approaches have been founded upon evidence which
was already potentially misleading, but has also been exaggerated and
distorted in ways that further misrepresent the reality of living with ill
health and disability.
The biopsychosocial model has been used to justify important changes

in the state's relationship to those with health problems, with new
obligations created for those suffering from common health problems,
such as the responsibility to "recognize that the sick role is temporary,
in the expectation of recovery." However it is not clear that these new
obligations are reasonable. There is a danger that the belief that it is
acceptable to encourage 'positive' views of ill health, disability and
the efficacy of treatments have affected the design and reporting of
medical research, encouraging unreasonable expectations of recovery.
A large and expensive assessment of biopsychosocial interventions,
the only such trial to have received funding from the Department of
Work and Pensions (DWP), provides a clear example of the problems
which can affect academic research and distort our understanding of
important issues. We will see how problems with the design of this
trial, and the presentation of its results, led to seriously misleading
claims about patients' recovery rates.
In a Lancet commentary, reviewed and approved by the trial's
researchers, patients were classed as having fulfilled a "strict criterion
for recovery" even though the criterion used was in fact so loose that
patients could have reported a worsening of all their symptoms and yet
still have been classed as recovered.
Despite the problems identified with the presentation of results the
trial's team continue to fight against releasing important data from
"IN THE EXPECTATION OF RECOVERY" | Summary
this publicly funded research, with pre-specified primary outcomes

remaining unreported. There have even been attempts to portray
Freedom of Information requests about this trial as a form of
harassment and stigmatise patients' concerns about the way in which
the efficacy of potential treatments are being misrepresented to them.
While there is a growing popular awareness of the problems with nonblinded or poorly controlled trials being used to make unjustified claims
about the value of alternative medicine, there is also a widespread
failure to acknowledge that more mainstream rehabilitative approaches
can be built upon a similarly poor evidence base. Greater honesty about
this is needed, especially as attempts to cut welfare spending lead
politicians to turn to rehabilitation as a key part of their policies on
disability, and as something which may become compulsory for those
claiming disability benefits.
Dubious claims of biopsychosocial expertise have been used to serve
the interests of influential institutions and individuals in government,
medical research and the insurance industry, where concerns about
money and reputation will inevitably compete with concerns about
public health and patients' rights.
This report will show the need for more critical engagement with
biopsychosocial medical research. There is a danger that the lives
of millions of people have been damaged by judgments based upon
inaccurate and misleading claims, shifting power away from those
suffering with ill health and disability by presenting policies which
reduce their options and income as benevolent and empowering
interventions.
"IN THE EXPECTATION OF RECOVERY" | The Biopsychosocial Model
The Biopsychosocial
Model
When ill health and disability limits people's ability to compete
in the labour market, opportunities are lost and costs created
for the individual, the welfare system, private insurers, potential
employers and society at large. It is in everyone's interest to see
those with health problems recover, and efficacious treatments
for common health problems would help us to avoid difficult
decisions about our priorities as a society. There will always be a
desire to curtail the cost of supporting those with ill health and
disabilities, yet this is balanced against a wish to avoid further
reducing the quality of life of those already facing hardship.
While effective medical treatments and rehabilitation would
help to minimise this dilemma, medical science does not always
progress at the speed we would like. That is not to say that
people will be unable to find research which tells them what
they want to hear.
Recent reforms to disability benefits have been founded on, and justified by, the
biopsychosocial model of disability. This model emphasises the role an individual's
cognitions, behaviour and social setting can play in perpetuating disability and a reliance
on benefit payments, while assuming that these factors can be altered and managed in
ways which help to restore functionality. Such an approach to disability and ill health
raises fundamental questions about the extent to which benefit claimants bear personal
responsibility for their own rehabilitation and return to work. It also leads to the concern
that a welfare system which provides a livable income to those with disabling health
problems may entrench worklessness and a culture of dependency. Instead of being
viewed as a way of diversifying risk and supporting those who have suffered misfortune,
social and private insurance systems can be understood as perverse incentives that pay
people to remain ill and keep them from the paid work which could be the most effective
treatment available to them.
To many people these concerns have an intuitive appeal, fitting with their own
ideological perspectives, yet they should still be treated with caution when they have
the potential to so profoundly impact the lives of those relying upon disability benefits.
Collecting robust evidence on the psychological and social aspects of disability is difficult
and problems with the systems surrounding medical research can lead to unfounded
and exaggerated claims. In this report a particularly large and expensive medical trial,
the first to have received funding from the Department of Work and Pensions (DWP),
will be used as an example of the problems which can affect medical research and
11
12
distort our understanding of important issues. This trial led to misleading claims about
biopsychosocial rehabilitation's recovery rates and attempts to discredit those seeking the
release of information which would have helped correct these misunderstandings. These
problems will be placed within the context of the use of the biopsychosocial model to
change the British state's relationship with those who live with ill health and disability.
Recent attempts to cut the cost of disability benefits may have been sold with the
rhetoric of empowerment and emancipation yet convincing evidence that they've led to
real improvements in the lives of disabled people has yet to be produced. The government
has refused to conduct a cumulative impact assessment on the effect of their changes on
the lives of disabled people[1], but recently released government figures report that the
proportion of disabled people who do not believe that they frequently have "choice and
control" over their lives has increased from 24% in 2008 to 35% in 2014[2-4].
Atos, the firm first contracted by the DWP to carry out their new assessments
of claimants for disability benefits, has stated that their examinations follow a
biopsychosocial model[5], yet generally disabled people do not see these assessments
as having helped to improve their lives[6-13]. Treating people as if they have more
power to overcome the burden of their health problems than they actually do can be
disempowering, even without the threat of a further loss of income. The good news
that one's health is less of a restriction than one believes needs to be accurate before it
can be welcomed, so it is important that the claims made about people's ability to find
employment, and the value of rehabilitative approaches, are reasonable and supported
by the evidence. Attempts to create a more positive outlook, and confident attitude, can
destroy trust, promote prejudices, and leave those suffering with health problems even
more isolated from society.
Within this report suggestions will be made for both the development of policy
and medical research in an attempt to help reduce the likelihood of similar problems
occurring in the future.
The responsibility to expect recovery

During a House of Lords debate on the abolition of Disability Living Allowance and its
replacement with Personal Independent Payments, Lord Freud, Minister for Welfare
Reforms at the Department of Work and Pensions (DWP), stated that:
"we have gone for the biopsychosocial model. That model has now garnered very
significant academic support, as those noble Lords to whom I sent that very
interesting piece of research will recognise."[14]
The circulated document had been written by Mansel Aylward and Gordon Waddell[15].
At the time of the debate Aylward, a former DWP chief medical officer, ran the Unum
Provident Centre for Psychosocial and Disability Research[16] while sitting on Atos
Healthcare's Clinical Governance Board.[17] He had helped develop LiMA, the software
used in Atos's disability assessments.[18] Their document laid out the biopsychosocial
model and explained that this model promoted a new conception of the 'sick role' which
served to dramatically increase the responsibilities of those living with health problems,
stating that "there needs to be a fundamental shift in the culture that surrounds work and
health, sickness and disability, and incapacity benefits."[15]
The biopsychosocial model allowed the banal observation that psycho-social factors
play an important role in how people feel and behave to be used as an excuse for dramatic
changes in the way the state interacts with those who have disabilities and ill health, even
though all human experience will include a psychological and social component. Those
with 'common health problems' are told that they must now recognise that "rehabilitation
depends on your own motivation and effort" and new obligations for these patients are
listed, such as:
"Recognize that the sick role is temporary, in the expectation of recovery
Be motivated and cooperate with rehabilitation"
So what are 'common health problems' and how good is the evidence that the
rehabilitative approaches patients supposedly have a responsibility to engage in truly
lead to the recovery which we are now told they should expect? The document cites a
DWP report, also co-authored by Gordon Waddell, Concepts of rehabilitation for the
management of common health problems. [19] Here it is claimed that 'common health
problems' "cause most long-term disability and incapacity" and "often consist primarily of
symptoms with limited evidence of objective disease or impairment" while "the obstacles
to recovery are often predominantly psychosocial in nature rather than the severity of
pathology or impairment."
On the matter of recovery it is stated that the biopsychosocial model changes how
disability is approached:
"it is no longer what makes some people develop long-term incapacity, but
why do some people with common health problems not recover as expected?
The development of long-term incapacity is a process in which biopsychosocial
factors, separately and in combination, aggravate and perpetuate disability.
Crucially for the present argument, these factors can also act as obstacles to
recovery and return to work. The logic of rehabilitation then shifts from attempts
to overcome, adapt or compensate for impairment to addressing factors that
delay or prevent expected recovery. Thus, management for common health
problems must specifically address and overcome those factors acting as obstacles
to recovery."
While this may sound like good news, the poor quality of the evidence supporting
biopsychosocial theories and approaches needed to be repeatedly recognised within the
report. The two areas where it was claimed there was stronger evidence were low back
pain and Chronic Fatigue Syndrome (CFS). For CFS it was stated that "there is promising
evidence on the effectiveness of graded exercise combined with cognitive behavioural
therapy". When Mansel Aylward was Chief Medical Adviser at the DWP he helped secure
DWP funding for a trial testing the efficacy of these interventions for CFS, and went on
to sit as an observer on the Trial Steering Committee.[20,21] Evidence to support the claims
being made about the value of the biopsychosocial model was needed and the 5+ million
PACE trial, the largest and most expensive of its kind, was expected to provide it.[22,23]
13
The PACE trial

The PACE trial was a multicentre randomised trial that collected data for a number
of outcome measures from the 641 participants placed into one of its four treatment
arms. Randomly allocating participants to treatment groups helps avoid the danger
that differences between groups' responses stem from prior differences between the
participants. Otherwise it could be that those patients with attributes that predict greater
improvements in health would tend to choose a particular treatment approach, creating
an association between that treatment and improved health even if the treatment itself
was ineffective.
It was decided that treatment efficacy would be assessed at fifty-two weeks postrandomisation, and the design of the trial allows for reasonable confidence that
significant differences between the groups' responses would be a result of having been
randomised to different interventions. Despite this strength, there were other problems
with the PACE trial's design, and the reporting of its results, that have led to misleading
claims about the efficacy of treatments and the likelihood of patients recovering.
1. What is 'Chronic Fatigue Syndrome'?
14
There are a wide range of contradictory views on CFS, with disagreement even on who
should be considered to have the condition. The PACE trial required all patients to fulfil
the Oxford criteria for CFS, a definition which has been widely criticised and requires
only that a patient has severe and disabling fatigue as the principal symptom, that other
fatiguing diseases have been excluded, and that the fatigue is not life-long but has lasted at
least six months.[24,25] A report for the National Institutes of Health recently recommended
that the Oxford criteria be retired, stating that "continuing to use the Oxford definition
may impair progress and cause harm".[26] Nonetheless, patients were selected for the
PACE trial using the Oxford criteria, and so this is how CFS will be defined within this
report (see the Appendix for more details on the Oxford criteria).
Beyond concerns about the specific criteria for diagnosing CFS, there are even
broader concerns about the value of Chronic Fatigue Syndrome as a label, with another
recent report, this one from the Institute of Medicine, concluding that 'Chronic Fatigue
Syndrome' was a misleading and unhelpful term which can lead to stigmatisation and
trivialisation of patients' health problems while placing undue emphasis upon 'fatigue'
(a concern shared by many patient organisations).[27] Despite the controversies and
uncertainty that surround CFS, it seems widely believed that patients with a range of
different and poorly understood health problems are being given the diagnosis and
that many of these people continue to be treated unfairly. The chair of the UK CFS/ME
Research Collaborative summarised the current understanding of CFS by stating that:
We are bathing in a bath of ignorance[28].
2. The problem with self-reported outcomes

One important difficulty with CFS is that we do not have a valid way of accurately
measuring subjective symptoms like fatigue (which the Oxford criteria requires to be a
patient's primary symptom).[24] It can also be difficult to assess the impact of interventions
like Cognitive Behavioural Therapy (CBT) and Graded Exercise Therapy (GET), where
trials cannot be double-blind, in the way expected of drug trials.
Two questionnaires had been chosen as the PACE trial's primary outcome measures
(one for fatigue and one for physical functioning, as detailed in the Appendix). These
questionnaires were to be used to assess the impact the different interventions had on
patients' health, yet we do not have evidence that these questionnaires are accurate and
valid measures of the effect interventions like CBT and GET have on patients' health.
Randomisation minimises the danger of allocation bias, but that does not mean that
other potential sources of bias can be ignored.
In the PACE trial therapists and patients knew what treatment was being provided,
introducing the risk of bias distorting results, particularly for self-report
questionnaires.[20,29,30] Patients who are encouraged to believe the interventions they are
receiving are effective, that they have greater control over symptoms and hence a failure
to improve may reflect poorly upon them, or who just spend more time with therapists
they believe are trying to help treat their symptoms, can report improvements in
questionnaires even when more objective measures of health do not improve. While this
may indicate some genuine improvement, it could merely reflect their wish to be positive,
or polite.[30-34]
Patients in all four of the trial's groups received 36 sessions of a basic intervention,
Specialist Medical Care (SMC), and this was all that was provided to patients in one of
the four groups. Those in the other three groups received an additional 1215 sessions
of therapy: Cognitive Behavioural Therapy (CBT), Graded Exercise Therapy (GET) or
Adaptive Pacing Therapy (APT).
The PACE team stated that:
"CBT was done on the basis of the fear avoidance theory of chronic fatigue syndrome.
This theory regards chronic fatigue syndrome as being reversible."[20]
"GET was done on the basis of deconditioning and exercise intolerance theories of
chronic fatigue syndrome. These theories assume that the syndrome is perpetuated
by reversible physiological changes of deconditioning and avoidance of activity."[20]
"APT was based on the envelope theory of chronic fatigue syndrome. This theory
regards chronic fatigue syndrome as an organic disease process that is not reversible
by changes in behaviour and which results in a reduced and finite amount (envelope)
of available energy."[20]
The patients receiving CBT and GET were told during treatment that these therapies had
already been shown to be effective and were provided with models of their illness that
emphasised their own ability to alter their behaviour in a way that would actively improve
their symptoms, while these claims were not made to those in the other two groups.[35]
Self-report outcomes can be affected by peoples' desire to be viewed favourably by
others. This is known as social desirability bias.[36] The therapists providing both CBT and
GET were trained to encourage gradual increases in activity (mostly walking for GET)
15
while in contrast those providing APT were told to encourage patients to follow the 70%
rule: never going beyond 70% of your perceived energy limit.[35] Approaches to illness
which emphasise patients' ability to overcome the limitations of their health through their
own efforts increase the danger of social desirability bias distorting self-report measures:
there's an added incentive to reporting an improvement in symptoms if you feel that
you can take some credit for it. The psychosocial components of CBT and GET included
elements intended to affect how patients think about their symptoms, possibly improving
self-report questionnaire scores merely by altering how patients view and talk about their
symptoms or disability without there being any real change in symptoms or disability.
These aspects of the PACE trial all added to the likelihood that self-report questionnaires
would be unreliable measures of patients' actual symptoms and disability.
3. The presentation of results
16
Another potential problem with medical trials is that researchers can make important
decisions about the presentation of results that dramatically alter how these results are
interpreted. When researchers want to be associated with successful interventions there
is a danger that they have an incentive to misrepresent their own data. To help avoid
problems with results being spun in this way, before all data had been collected the PACE
research team published a trial protocol which laid out how results were to be analysed
and released.[37] Whilst publishing the protocol after the trial had already started was not
ideal, as non-blinded trials will allow researchers a sense of treatment efficacy even before
results are collected, this protocol should still have reduced the danger of results being
presented in a misleading manner.
The PACE trial's objective outcome measures

Once the PACE trial's protocol had been published and it was made clear that self-report
questionnaires were being used as the trial's primary outcome measures, responses raised
concerns about the marginal use of more objective outcome measures. In particular,
the decision to use actometers (devices used to measure movement) to assess patients'
activity levels only at the start of the trial, and not after treatment as an outcome measure,
was queried.[38]
One of the PACE trial's three principal investigators had previously stated that:
The heart of CBT is a behavioural approach to the impairment of activity that is

part of the definition of CFS,[39]
and that an increase in activity
must ultimately be the aim of any treatment. [40]

Another principal investigator stated, when promoting results from the PACE trial,
that CBT:
"aims to help people be able to gradually increase activity".[41]
The decision to not measure the effect of these interventions on patients' activity levels
was therefore a surprising one.
The explanation for this decision provided by the PACE team was that while they had
intended to use actometers as an outcome measure, it was then decided "that a test that
required participants to wear an actometer around their ankle for a week was too great a
burden at the end of the trial".[38] After the PACE trial's protocol was published actometer
results from three earlier trials of CBT for CFS were released.[42] If real improvements
in patients' disabling fatigue were occurring as a result of CBT, then one would expect
treatment to allow patients to increase their activity levels, yet this data showed that CBT
led only to improvements in self-report measures and did not lead to increases in patients
actual activity levels.
In response to broader concerns about the lack of objective measures of outcome, the
PACE team stated that:
We have used several objective outcome measures; the six-minute walking test, a
test of physical fitness, as well as occupational and health economic outcomes.[38]
Results for these outcomes have now been released and they show that, despite adherence
to treatment being rated highly for both CBT and GET, CBT did not lead to improvement
in employment, physical fitness, or 6-min walking test outcomes.[20,43,44] GET did not
lead to improvement in employment or physical fitness, and the six-minute walking test
showed an improvement that was statistically significant but fell short of the criteria used
elsewhere in the trial to define a clinically useful difference.[20,43,44]
The poor results from these more objective outcome measures have not been focused
upon by the trial's researchers, who have chosen not to mention them in the abstracts of
any of the nine papers they published on the PACE trial since results have been
released.[20,43-51] Nor, as we will see, have they led to a more tempered promotion of the
results for the trial's more subjective self-report measures. Table 1 shows the result of the
subjective self-report measures.
Data from the non-blinded PACE trial showed that randomisation to CBT and
GET was associated with greater improvements in self-reported fatigue and physicalfunctioning questionnaire scores at 52 weeks post randomisation, but we cannot know
if this reflects any genuine improvement in patients' health. Results for the trial's more
objective outcome measures would seem to indicate that it does not. Results for the PACE
trial's primary outcome measures were not released in the manner laid out in the trial's
published protocol.
17
3158 patients screened
641 patients met the trial entry criteria

and were randomly allocated to treatment groups
160 assigned
to SMC alone
161 assigned
to SMC+CBT
160 assigned
to SMC+GET
160 assigned
to SMC+APT
Likert Chalder
Fatigue
Questionnaire
(CFQ): mean
(SD)
283 (36)
277 (37)
282 (38)
285 (40)
SF36-Physical
Functioning
scale: mean
(SD)
392 (154)
390 (153)
367 (154)
372 (169)
8 lost to follow
up
14 withdrew
13 lost to
follow up
17 withdrew
6 lost to follow
up
10 withdrew
6 lost to follow
up
11 withdrew
157 analysed
155 analysed
159 analysed
159 analysed
Reported results
at 52 weeks post
randomisation[20,45]
SMC
SMC + CBT
SMC + GET
SMC + APT
Likert CFQ:
mean (SD)
23.8 (6.6)
20.3 (8.0)
20.6 (7.5)
23.1 (7.3)
Mean CFQ
difference from
SMC (95% CI)
34 (50 to
18)
32 (48 to
17)
07 (23 to
09)
SF36-PF - mean 50.8 (24.7)

(SD)
58.2 (24.1)
57.7 (26.5)
459 (24.9)
Mean SF36-PF
difference from
SMC (95% CI)
71 (20 to 121) 94 (44 to 144) 34 (84 to

16)
Baseline scores
18
'Back to
normal'
15%
30%
28%
16%
Trial recovery
7%
22%
22%
8%
Clinical
recovery
7%
21%
21%
8%
TABLE 1. The Pace Trial's Subjective Outcome Measures
Redefining 'recovery'
When results from the PACE trial were first released in The Lancet in 2011, they led
to widespread claims of a recovery rate of just under a third for CBT and GET, with
the British Medical Journal reporting that 30% and 28% of patients respectively had
been "cured" by these treatments.[52-59] These claims were not based upon results for the
recovery criteria laid out in the trial's protocol, but upon a new outcome devised by the
trial's researchers after they had seen the trial's results.[20]
Accompanying the release of results was a Lancet commentary, reviewed and approved
by the trial's researchers, which claimed that "about 30%" of patients who'd received CBT
and GET satisfied a "strict criterion for recovery", even though the criterion used was in
fact so loose that patients could have reported a worsening of all their symptoms during
the trial and yet still been classed as recovered.[54] The PACE team had created a post-hoc
outcome for patients who had an SF36-Physical Function score of 60 or over and a
Chalder Fatigue Scale score of 18 or under, describing these patients as "back to normal"
to the media and in a leaflet for patients.[59,60] This meant that, even ignoring potential
problems with bias on self-report questionnaires, patients could start the trial being
classed as suffering from fatigue which was severe and disabling, then report a worsening
of both their fatigue and physical functioning following treatment, and yet still be classed
as "back to normal", "recovered" and "cured".[20,52-54,59,60]
Within the Lancet paper these participants were described as "within normal ranges for
both primary outcomes at 52 weeks", with these normal ranges having been newly created
for this paper in response to a suggestion made during peer review.[20] The new SF36-PF
and Chalder Fatigue Questionnaire normal ranges were the foundation of the PACE
team's "back to normal" outcome, and also for later released criteria for "trial recovery"
and "clinical recovery". These new ranges differed from those described in the PACE trial
protocol, and there were problems with the justifications for changing both.
For the Chalder Fatigue Questionnaire, patients could now be counted as recovered
even if they had a Likert score of up to 18 (out of 33, with a higher score indicating
greater fatigue), when that is worse than the score of 12 which patients could have
reported at the start of the trial when being classed as suffering from fatigue which was
"severe, disabling and affects physical and mental functioning".[20,22,24] This change to the
'recovery' criteria was justified by reference to a paper recently published[61] by one of the
PACE trial's principal investigators (Trudie Chalder) which re-analysed data collected for
a paper which she had co-authored in 1994[62], long before the PACE trial's protocol was
written and published.[37] This 'new' data was used to claim that higher levels of fatigue
within the general population justified a looser interpretation of fatigue scores both in the
initial Lancet paper, and in their later publication dedicated to the PACE trial's recovery
rates.[45] Further information on the Chalder Fatigue Questionnaire and how it is scored is
available in Appendix.
For the Physical Functioning Questionnaire (SF36-PF), the trial protocol had required
patients to have a score of at least 85 (out of a maximum of 100, with a higher score
indicating greater physical function) in order to be classed as recovered, while those
scoring 75 or more, or whose score improved by 50% or more, could be counted as
having a "positive outcome".[37] A score of 65 or under was part of the trial's entry criteria,
which required that patients be suffering from fatigue which was "severe, disabling and
affects physical and mental functioning".[20,22,24]
19
20
Once the trial was over the PACE team decided that those scoring as low as 60 could
be counted as recovered. The claim that patients with a score of 60 had returned to a
normal level of physical functioning was initially justified by stating that 60 was "the
mean minus 1 SD scores of the UK working age population of 84(24)"[20,60], but it was
later acknowledged that this mean and standard deviation was from a population which
included the scores of all those aged over 65.[63] As people tend to report lower levels
of physical functioning when they get older this lowered the sample's mean physical
function score as well as increasing the standard deviation. The mean minus 1 SD for
those of working age was actually 71.[64,65]
The PACE team had chosen new SF-36 PF population data to devise their new normal
range, and it was reported that they now "believed this to be the most representative study
for the trial sample".[66] Fortunately, the new population data cited by the PACE team is
available at the UK Data Archive, allowing us to look more closely at the validity of the
justifications used for their redefinition of recovery.[64,65] After acknowledging that they
had included data from elderly members of the population to derive a score of 60, the
PACE team then again used a cut-off of 60 in their later paper specifically on recovery
rates from the PACE trial.[45] They reported that the recovery criteria pre-specified in the
trial's protocol was abandoned as a cut-off 85 was too demanding, supposedly meaning
that approximately half the general working age population would fall outside the
normal range. The data they cite actually shows that only 17.7% of the general working
age population, including all those with short and long-term health problems, scored
under 85 (illustrated in Figure 1)[65]. Furthermore, the trial's protocol indicates that the
criteria for recovery (which included requiring that patients have a physical functioning
score of 85 or over) was intended to be more demanding than the criteria for the mean
-1SD normal range, stating that "A score of 70 is about one standard deviation below the
mean... for the UK adult population.[37]
1,000
The PACE trial's published protocol required patients to report a

score of at least 85 before they could be classed as recovered.
After results were collected, this was lowered to 60, justified by the
inaccurate claim that "approximately half" of the working age
population had a score under 85, when the data they cited actually
showed only 17.7% scored lower than this. Patients had entered
the trial with a score of 65 and were considered to be suffering
fatigue which is "severe, disabling and affects physical and mental
functioning", yet these patients could get "back to normal" and
"recover" even if reporting a decline in physical functioning.
800
600
frequency in
working-age
sample
400
Functioning at 85 or more = 82.3% of working age population

Functioning at less than 85 = 17.7% of working age population
200
0
10
15
20
25
30
35
40
45
50
55
SF36-PF score
60
65
70
75
80
85
Source: Frequency of SF-36 Physical Functioning scores within the working-age population, including
all those suffering from ill health and disability. OPCS Omnibus Survey, November 1992
FIGURE 1. Distribution of SF36-Physical Functioning in Working Age Population
90
95 100
While one of the PACE trial's principal investigators has argued that the inclusion of
some elderly patients among the PACE trial participants means that it is fair to compare
results to scores from a population including all those aged over 65, only 3% of the PACE
trial's participants were aged 60 and over[67], compared 32% of the population actually
used to define the recovery criteria, which would be reduced to 9% if those aged 65
and over are removed from the sample.[65] The PACE trial's participants were actually a
marginally younger group than the working age sample, with a mean age of 38 (SD 12)
compared to 40(13), while the general population data actually used by the PACE team
had a mean age of 48(19).[65,67]
The data cited by the PACE trial, and illustrated in Figure 1, shows that the majority of
the working age population reported the maximum SF36-PF score of 100, and that 91%
of this population scored over 60, even though 15% reported having a long term health
problem and an additional 13% reported needing to visit their doctor in the previous
two weeks.[65] Within the PACE trial's recovery paper it was claimed that another study
assessing recovery after CBT for CFS had used a similar criteria to their own, "but the
definition for normal range used was the more liberal population mean -2 SD rather
than the more conservative 1 SD that we used".[45] This was not true, and the study cited
actually used a more stringent criteria of "the mean plus (or minus) 1 standard deviation
(SD) of the healthy population", requiring patients to have an SF36-PF score of at least
80.[68] Claiming that those patients scoring just 60 had been returned to a normal level
of function, and could be considered recovered, served to mislead people about both
the efficacy of the treatments developed by the PACE trial's principal investigators, and
the extent to which managing patients' cognitions and behaviours could help them to
overcome their health problems.[52-60]
For the PACE trial's later, and less widely covered, recovery paper[45] there were also
additional components to the recovery criteria, which again deviated from those laid out
in the trial's protocol. [37] Patients were asked to self-rate their health improvement, giving
a score from 1-7 with 1 representing "very much better" and 7 "very much worse". The
protocol recovery criteria had required patients have a score of 1, but this was changed to
include those with a score of 2, representing 'much better'. No research was cited to justify
this change, just the researchers' claim that they now "considered that participants rating
their overall health as much better represented the process of recovery.
In order to satisfy the 'trial recovery' criteria[45] it was stated that patients could
not simultaneously fulfil the Oxford criteria for CFS, and this was not presented as a
deviation from the protocol recovery criteria. However, by the time of the recovery paper
it was decided that fulfilling the Oxford criteria now required that patients have a Chalder
Fatigue Questionnaire score of 6 or more and a SF36-PF sub-scale score of 65 or less. In
the 2011 Lancet paper those requirements for entry to the trial were described separately
from the Oxford criteria, and listed as "other eligibility criteria". During the screening
process for the PACE trial 235 patients were excluded because they reported a SF36-PF
score of over 65 and 29 were excluded for have a Chalder Fatigue score of less than 6,
separately from the 1011 excluded for not fulfilling the Oxford criteria.[20] It appears that
this was an undeclared deviation from the trial's protocol. The entry criteria for the FINE
trial, described as PACE's sister trial, also required the Oxford criteria for CFS be fulfilled,
but included patients who had a SF36-PF score of 70, and a bimodal Chalder Fatigue
score of 4. Patients who fulfilled the most demanding recovery criteria for which results
were released from the PACE trial could still have fulfilled the entry criteria for FINE, and
been considered to suffer from severe and disabling
fatigue. [159]
21
"IN THE EXPECTATION OF RECOVERY" | The Politics of Distorted Research
The Politics of Distorted

Research
Ongoing attempts to dismiss concerns and avoid
releasing data
Troubled by the way results from the PACE trial were released, patient organisations
made a joint Freedom of Information request for the results of those outcome measures
laid out in the trial's protocol but not published in the trial's initial paper.[20,37,69] The
response to this stated that the results for the protocol's recovery criteria were exempt
from the Freedom of Information Act as they would soon be published in an academic
journal.[66] This turned out not to be true. A later FOI request for these recovery results
was refused by stating that the PACE team had not calculated these results and therefore:
"the requested data relating to the recovery rates and positive outcomes do not
exist."[70]
22
More recently it was argued that performing the analysis needed to generate these results
would cost more than the appropriate limit laid out in the Freedom of Information
Act (450): supposedly Queen Mary University of London, who hold the data, would
need to hire and train a new statistician in order to do the work.[71] It is surprising that a
university does not already employ someone able to perform this analysis.
Regardless of the justification given it is clear that the PACE team do not want to
release this information, and there have even been attempts to stigmatise concerns about
the PACE trial and the way in which CBT and GET have been promoted, presenting
complaints as stemming from an unreasonable opposition to psychiatry, while Freedom
of Information requests are portrayed as a form of harassment.[56,72-79] These attempts
may now be starting to crumble, with researchers from outside the interconnected
community of British medical research beginning to intervene. Last year an article in
the American Psychology Association's magazine, Monitor, reported that a number of
experts have taken issue with the PACE trial's definition of recovery[80] and an Australian
researcher wrote a commentary which focused on problems with the way the PACE trial's
team presented their results on recovery.[81] This was followed by an Evidence Review
conducted for the American government which singled out the PACE trial's new recovery
criteria for criticism, describing it as "contradictory".[82] Even the British Medical Journal,
having played an important role in attempts to discredit concerns about the PACE
trial[52,73], recently published an editorial by two (non-British) long-term supporters of
CBT and GET for CFS acknowledging problems with the "unduly liberal" way recovery
was defined in the PACE trial.[83] A summary of more recent developments is included in
the Appendix.
Conflicts of Interest
The failure to release results for the pre-specified analyses laid out in the PACE trial's
protocol is of particular note as concerns had already been expressed about the
ideological biases of the trial's three principal investigators. All three have built their
careers upon the development of biopsychosocial interventions for CFS, and the two who
had been part of the Chief Medical Officer's CFS working group both resigned because
the active biopsychosocial approaches of CBT and GET were not endorsed over 'pacing'
in the way that they had wanted.[84-86] The trial's protocol reported that "all staff involved
in the PACE trial recorded their expectations as to which intervention would be most
efficacious"[37], and while this data has yet to be released it seems reasonable to assume
that the trial's principal investigators favoured CBT and GET.
All three principal investigators also reported conflicts of interest involving the
insurance industry.[20] There has long been concern about private insurance companies
influencing changes to the UK welfare state, a system of social insurance that they must
compete against.[8,87-90] These concerns seem likely to continue following reports of
David Cameron's interest in encouraging individuals to fund their own unemployment
or sickness benefits privately through financial products.[91,92] When Michael ODonnell
was the Chief Medical Officer at Unum insurance (and before he moved on to Atos, and
then Maximus[90]), he wrote an internal document promoting the biopsychosocial model
and claiming that Unum's thinking, along with that of their close associates, was driving
government policy.[93,94] More recently Unum funded a report from the think-tank Demos
which encouraged the UK government to use private financial products to supplement
social welfare.[95]
Back in 1995 a Unum report on CFS stated that they could "lose millions if we do
not move quickly to address this increasing problem".[96] It was argued that CFS claims
should be managed "more aggressively and in a proactive rather than a reactive fashion"
while attempting to present CFS as "neurosis with a new banner". Emphasising the
importance of psychosocial factors and classing CFS as a mental health problem could
bring immediate financial benefits to insurance companies when policies limit payouts
for mental health problems. One of the PACE trial's principal investigators gave a
presentation on the results of the PACE trial to Swiss Re insurance. Swiss Re's report of
his talk detailed the potential use of mental health exclusions to cut payments[97], while a
2013 Swiss Re presentation on their approaches to mental health problems describes their
use of specific exclusions for CFS and ME.[98]
During the Swiss Re presentation on PACE no mention seems to have been made of the
fact that PACE found neither CBT nor GET were associated with improved employment
outcomes, and instead Swiss Re's claims managers continued to be encouraged to believe
that promoting these active rehabilitative approaches would assist return to work.[97]
There has been concern about insurance companies pushing some patients with CFS to
take part in CBT and GET against their wishes. A response to the paper which published
the PACE trial's data on employment outcomes was titled Coercive practices by insurance
companies and others should stop following the publication of these results[99], but has yet to
receive a response from the PACE team.
23
In 2006 a Parliamentary All Party Group inquiry into CFS/ME claimed that:
"There have been numerous cases where advisors to the DWP have also had
consultancy roles in medical insurance companies. Particularly the company
UNUM Provident. Given the vested interest private medical insurance companies
have in ensuring CFS/ME remain classified as a psychosocial illness there is
blatant conflict of interest here. The Group find this to be an area for serious
concern and recommends a full investigation of this possibility by the appropriate
standards body."[100]
Perverse incentives
"It is difficult to get a man to understand something, when his salary depends
upon his not understanding it!"[101]
24
It is more difficult to assess the affect of biopsychosocial interventions on subjective

symptoms than interventions for which double-blind trials can be conducted. The
patient and therapist cannot help but be aware of the claims made during therapy and the
approach being taken. An inability to overcome these problems seems to have led to a
lowering of standards for biopsychosocial research. Had homeopaths or a pharmaceutical
company conducted a trial and presented results in the manner of the PACE trial
the British research community would have been unlikely to overlook its problems.
A willingness to systematically lower standards for one area of research means that
exaggerated claims about the value of work here are more likely to be accepted, distorting
society's view of important issues.[34,102]
One influential paper examining the widespread problems found within medical
research reminded readers that entire fields of scientific endeavour are likely to be
nothing more than wasted effort, measuring bias, without yielding true scientific
information. It goes on to point out that:
"Of course, investigators working in any field are likely to resist accepting that the
whole field in which they have spent their careers is a 'null field'."[103]
It is not just those researchers directly involved in the biopsychosocial project who have
incentives to avoid recognising the problems with research in this area, but also the
network of journals, research funders and universities whose own reputation and prestige
might be damaged by acknowledging error, exaggeration and incompetence. When
the biopsychosocial model serves the interests of so many of those with authority and
influence it increases the danger that legitimate criticism will be resisted and denounced
rather than recognised and acted upon.
The first time a trial indicated that CBT was no more effective than placebo at allowing
CFS patients to increase their activity levels[104] those who had developed CBT for CFS
argued that this result meant that the CBT could not have been conducted properly, as
patients who were not able to increase their activity levels as a part of the therapy would
have needed to drop out, leaving only those with raised activity levels to complete the
programme:
"At the heart of CBT is a behavioral approach to the impairment of activity that
is part of the definition of CFS" and
"if a patient completes the program, he or she must have increased their
activity, even if everything else remains unchanged. We therefore suggest that
patients... may have attended the sessions, but did not comply with the program
by gaining targets and carrying out homework. If the patients were compliant
with the program, then by definition the number of sedentary hours must have
decreased."[39]
As evidence from other trials continued to indicate that CBT failed to increase patients'
activity levels, researchers in this area seemed to decide amongst themselves that actually
CBT should not be expected to lead to increases in activity, and that performing like a
placebo in changing only subjective self-report measures in non-blinded trials would
be all that is needed to claim success.[20,42,82,105] In response to concern that changes in
self-report outcomes in non-blinded trials of CBT may reflect only biases and placebo
response rather than real changes in health, particularly given the failure to improve
objective outcome measures, the PACE team merely asserted that self-rated outcomes
"are the most appropriate measures to judge improvement in an illness that is

currently defined by symptoms".[106,107]
In response to a letter of my own on this topic the PACE team stated that they had
already addressed these concerns in detail.[108,109] I received no reply when I wrote to the
corresponding author to ask where these points had been addressed in detail. If people
are able to choose how to assess the value of their own work, they are unlikely to decide
upon the method which indicates that their work is worth less.
25
"IN THE EXPECTATION OF RECOVERY" | Research Distorted by Politics
Research Distorted
by Politics
Cruel to be kind
"Behavioural approaches try to extinguish observed illness behaviour by
withdrawal of negative reinforcements such as medication, sympathetic
attention, rest, and release from duties, and to encourage healthy behaviour by
positive reinforcement: operant-conditioning using strong feedback on progress."
Waddell and Burton[19]
26
Emphasising the role that reversible psychosocial factors play in benefit claimants'
disability allows politicians to present plans to 'slash' welfare spending as a 'moral
mission' to help people overcome a culture of dependency.[110-122] Claiming that changes
to disability benefits are needed to account for 'today's understanding of disability',
supported by the work of medical researchers, helps politicians sidestep important moral
and political debates, even if the research is poor and the results misrepresented.[116-119]
Curing the sick would be a good way of cutting the social cost of disability, but if these
cures involve nothing more than encouraging people to complete questionnaires more
positively, and then changing how those questionnaires are interpreted, an emphasis on
'rehabilitation' is unlikely to be as useful as might be assumed.
Were a politician to argue that those whose health prevents them from working should
be refused disability benefits if they do not to try to adopt the cognitions, attitudes
and behaviour desired by the state many voters would instinctively recoil. They may
be less likely to do so in response to the argument that, instead of just 'writing-off '
disabled people to a life on benefits, it would be better to make benefits conditional
on co-operation with evidence-based rehabilitative approaches that will help people
re-engage with, and feel valued by, society. The power to re-label and re-classify, changing
official uses of language, helps academics and politicians further their own interests.
The general public will find it easier to understand an announcement that from now on
many of those who receive Incapacity Benefit will have payments reduced by nearly a
third, than the news that the incomes of those joining the Work-Related Activity Group
(WRAG) of Employment and Support Allowance (ESA) will now be aligned with that of
those on Job Seekers Allowance. Such tongue-twister labels makes communicating clearly
and concisely on these topics difficult.
The most recent disability cuts reduce ESA WRAG payments for new claimants from
102.15 a week to 73.10. A leaked Whitehall paper attempted to justify these cuts by
arguing that ESA was a "passive" benefit which does not "incentivise" people to find
a job.[120,121]
Calling for Labour to support the legislation making these cuts, George Osborne
argued that:
"We will protect the most vulnerable disabled people, pensioners, who cannot
change their circumstances, and those most in need."[122]
Those being encouraged to adopt positive beliefs about recovery and their ability to
change their circumstances may now be seeing these beliefs used as a justification for
cutting their income. This well-meaning attempt to proactively provide the empowering
poverty needed to help people overcome their adoption of the sick role reflects a view of
those with health problems that may appeal to the British Establishment, but is poorly
supported by the evidence.
The rise of the Biopsychosocial Model

"I think the biggest break I got was that Waddell and Burton had put out a
document three months earlier that said that work is good for you. There I was
looking at a system built up over a number of years that effectively protected
people from work if theyd got a problem single mothers, disabled people and I
thought to myself, this is bizarre. Here we have developed a system on entirely the
wrong premise which basically makes people ill."
Lord Freud explaining what guided his approach to welfare reform.[123]
The biopsychosocial model had been gaining influence within the British government for
some time. In 1993 Mansel Aylward invited psychiatrist Simon Wessely to give a talk on
his biopsychosocial approach to CFS before the then Minister for Social Security.
It was recorded that Wessely claimed:
"As regards benefits:- it is important to avoid anything that suggests that

disability is permanent, progressive or unchanging. Benefits can often make
patients worse."[124]
Even without good supporting evidence for his claims, this is the sort of expertise likely
to appeal to a Minister for Social Security looking to cut costs, and with the rise of New
Labour there came a strong cross-party belief that action needed to be taken to reduce the
cost of disability benefits.[89,125,126]
It was New Labour that truly embraced the biopsychosocial approach and its
implications for how those with health problems and disabilities should be viewed
and treated[19,126,127]: prioritising the use of positive language over dealing honestly with
difficult realities seemed to unite both movements.
The Blair government's first attempt at cutting disability benefits was greeted with
revolt and protests, despite an early attempt to "shift the focus from one of cost-cutting to
one of enabling".[127-130] Since then attempts to shift the focus have been more successful.
Both major parties and much of the media have been emphasising the role of attitudinal
problems in preventing those with disabilities from finding work, and concerns that
disability benefits were trapping people in a culture of dependency.[125, 131-133] An analysis
of public attitudes to welfare reported that the percentage of people who would like to
27
see more public spending on 'disabled people who cannot work' dropped from 74% in
1998 to 53% in 2011.[134] It was suggested that this drop was a result of the Labour party's
changing attitude to disabled people and also a growing belief that people are wrongly
claiming to be unable to work.[134]
In 2002 all three of the PACE trial's principal investigators, along with Aylward,
Waddell and Wessely, contributed to a conference and book which promoted the use
of the biopsychosocial model.[127] The book was made up of conference papers and
transcripts of discussions, and includes Waddell explaining how the biopsychosocial
model was gaining political influence:
"It is all about money. The main thing was to persuade the treasury that there
was an opportunity for keeping costs down, particularly over the longer term."
28
In response to another participant saying "if you go to Gordon Brown (UK Chancellor)
and say, 'We can prove to you that if we address this issue, we can save 2 billion', then
you will have his full attention", Mansel Aylward replied: "That is the approach that has
been taken, but not in such a robust fashion."[127]
Their discussions explained how, within government, the antipathy caused by the
view that the biopsychosocial model lacked a hard evidence base had been overcome
by the softer evidence of "authoritative and expert opinion". Unfortunately, those
selected for their authoritative and expert opinions may not have risen to positions of
influence because of their moral integrity and intellectual rigour. Systematic reviews were
also described as being important for changing the views of key opinion makers, yet
systematic reviews may merely combine results from a number of different non-blinded
trials, putting aside problems with bias and making potentially misleading results appear
more reliable than they truly are. [135]
If politicians are not willing and able to engage critically with the scientific and medical
evidence presented to them they could easily be manipulated.
Gordon Waddell pointed out that evidence may not even be what is needed to change
people's minds:
"To take this a stage further, I am not sure that evidence is what convinces people.
We do need an evidence base, but it is ideas that really influence people. People
go to war for ideas, not for evidence. When you look at changing practice, it is
really about ideas rather than evidence."
The biopsychosocial approach to disability was an appealing idea (to some) lacking a
solid evidence base. It has now been used to present cuts to the incomes of sick and
disabled people as a caring intervention in their lives.
The power of the 'evidence-based' label

"I used to be stupid. I'm not stupid anymore because my findings are based
on evidence rather than supposition. And yes, I am arrogant, to some extent,
because I don't see anything wrong with being arrogant if you think that what
you're doing is right, and what you are doing is based on sound evidence."
Mansel Aylward [136]
The 2015 Conservative Party manifesto stated:
"We will review how best to support those suffering from long-term yet treatable
conditions, such as drug or alcohol addiction, or obesity, back into work. People
who might benefit from treatment should get the medical help they need so they
can return to work. If they refuse a recommended treatment, we will review
whether their benefits should be reduced."[137]
Waddell's DWP report on Common Health Problems[19] had suggested the same thing:
"receipt of IB [incapacity benefit] being conditional upon participation in

rehabilitation, though that would depend on the available interventions being of
proven value."
While therapists' professional bodies have expressed concern about proposals for forced
treatment, none have taken the time to acknowledge the extent to which their members'
exaggerated claims about the value of treatments have promoted the unreasonable
assumptions about those claiming disability benefits which in turn encouraged
politicians' frustration with those who fail to recover.[138,139]
When only limited funds are available this can lead to competition between those who
think that money should be spent on therapists and those who believe that money should
be provided directly to those with health problems. The recent drive to increase access to
psychological therapies (IAPT) in the UK was funded partly because it was claimed that
it would pay for itself by reducing the costs of welfare payments and increasing taxes paid
by those returning to work.[140] It is not clear how many of the psychological therapies
for which access has been increased are truly more effective than a well designed placebo
intervention, or that providing money to these therapists is the best way of improving the
opportunities of those with health problems.
One of the PACE trial's principal investigators, Trudie Chalder, was President of the
British Association for Behavioural and Cognitive Psychotherapies from 2012-14, and in
their statement criticising the proposal for coercive therapy, the BABCP also make clear
that they are not opposed to providing CBT in Jobcentres in order to increase fitness to
work so long as such therapies were 'evidence-based'.[139] Would they consider CBT to
be an 'evidence-based' intervention for improving function in CFS? Would Chalder's
claims in the media about patients getting "back to normal" be considered a breach of
BABCP standards for accurate advertising?[141] I fear that their standards for themselves
and their members may not be as high as they should be, and that the low standards in
this area reflect the prejudices and stigma which surround mental health. In response
to the Government's No Decision About Me Without Me paper, the Royal College of
General Practitioners expressed concerns about plans to allow patients more control over
their healthcare, presenting CFS as a psychological problem which meant that patients'
preferences may be dangerous:
"And what of patients with complex psychological problems, such as Chronic

Fatigue Syndrome, where a choice of treatment might do more harm than
good?"[142]
The PACE trial's principal investigators had previously stated that "when asked to
comment on benefits or insurance claims we support the patient as much as is possible,
29
30
but do not support claims for permanent disability or medical retirement until all
reasonable efforts at rehabilitation have been tried"[143], and that for sickness benefits
"individual [CFS] cases should be treated on their merits, but it is reasonable to expect
a patient to cooperate with treatment before being labelled as chronically disabled."[144]
One of the experts called upon to promote the PACE trials stated that the trial's results
suggested "every patient who wishes to be helped should be willing to try one or both
of the treatments."[145] I do not believe that patients should be expected to engage in
treatments that they do not want, especially when the evidence for their efficacy is as poor
as that seen for CBT and GET for CFS.
Threatening to strip patients of financial support for not pursuing particular
interventions may be seen as a step too far, but misrepresenting a treatment's recovery
rates already serves to rob patients of the ability to make informed decisions about their
healthcare and their lives. It is important that those with health problems are able to trust
the information provided by their doctors, but too often the biopsychosocial model's
emphasis on the benefits of 'reassuring' and 'empowering' cognitions has encouraged
manipulation and dishonesty as a form of therapeutic wish-thinking that also plays in to
the self-interest and prejudices of those working in government, the insurance industry
and in medicine.[144-147]
Exaggerating the extent to which patients can recover from their health problems
through changing their cognitions and behaviour does not only distort patients'
behaviour and how they think of themselves, but has political and social effects upon
how others treat them too. There is a danger that attempts to promote positive and
empowering cognitions amongst the sick has led to a dangerous spread of 'positive'
delusions about ill health and disability, and that policy-makers will now resist a bumpy
and expensive return to reality.
Prior to the publication of the 2015 Conservative Party manifesto, their intent to
include a proposal for mandatory treatments for those claiming benefits was floated in
The Daily Telegraph, and justified by a 'senior government source' with the claim that:
"Cognitive behavioural therapies work and they get people stable again but you
cant mandate people to take that treatment" and
there are loads of people who claim ESA who undergo no treatment whatsoever.
It is bizarre. This is a real problem because we want people to get better."[119]
The source was reported to suggest that:
"successful treatments could reduce the numbers of people with mental health
issues claiming the benefits by up to 90 per cent."
It is difficult to see how this figure could be justified by the evidence, however we have
seen how a desire to be 'positive' can lead to cumulative distortions as information is
passed from one person to another and it is difficult to know how far from reality senior
members of the government have now drifted.[148,149] (As illustrated in the Appendix.)
In Waddell's DWP report on Common Health Problems[19], aside from CFS, the other
bright spot for evidence of the benefits of a biopsychosocial approach was low back pain.
Unfortunately, results from medical trials have been disappointing here too. A recent
Cochrane review of biopsychosocial rehabilitation for low back pain found that nonblinded trials showed some improvements in questionnaire scores prone to bias, but no
improvement in the harder outcome of work status.[150]
At one point Waddell's report stated that
"it is important to bear in mind that the lack of scientific evidence is not the same
as evidence that something is ineffective".[19]
This is true, but not a good foundation for cuts to spending on support for those with
health problems, where it is fair to expect a degree of caution from those who could
further their careers with bold speculations. The way in which the biopsychosocial model
has been used and promoted, without good supporting evidence for many of the claims
being made, is unethical.
31
"IN THE EXPECTATION OF RECOVERY" | Conclusion
Conclusion
Policy implications
32
Medical research can be used to justify assertions of political power and any attempt
to reform the state's relationship with those with disabilities and ill health should be
founded upon a rigorous examination of the available evidence. Researchers need to be
honest and clear about the limitations of their research and their ability to accurately
measure subjective symptoms.
Policy makers need to recognise that researchers can be influenced by their own selfinterest, and that those who rise to prominence may do so through their own ability to
play political games rather than because of the high quality of their work. The political
power that comes with classing any rehabilitative approach as 'evidence-based' means
that those involved in medical research need to do more to acknowledge the limitations
of non-blinded trials using subjective self-report questionnaires as their outcomes, and
results from these trials need to be placed in the context of what we know about the
dangers of bias and the effect of placebos.
We also need to ensure that results are presented clearly and fairly so that patients and
policy makers can make informed judgments about the value of available interventions. A
small first step in this regard would be to ensure that results for all the outcome measures
laid out in the PACE trial's protocol are now made available to the public who paid for it.
Dangerous assumptions
The biopsychosocial model has played a significant role in shaping the UK government's
approach to disability and welfare over the last two decades, yet some important claims
made about the value and benefits of biopsychosocial approaches have been based upon
poor quality evidence and misleading claims. Even as awareness of these problems
grows, many aspects of the biopsychosocial model are so advantageous to those wishing
to justify cuts to state disability benefits that they are unlikely to be abandoned. While
it may be that explicit references to the biopsychosocial model will now be avoided, the
tactic of using the positive language of empowerment to promote policies which will
cut the incomes of members of society living with ill health and disability looks likely
to continue. So long as cuts to disability spending can go on being sold in this manner
they will be a politically soft target for a government committed to finding 12 billion of
welfare savings.[137]
It is not just in the political sphere that the biopsychosocial model has caused problems.
While there can be an assumption that medical researchers are more trustworthy than
politicians, and that the interventions they promote as being 'evidence-based' will benefit
patients, results from medical research can be exaggerated and misrepresented. When the
biopsychosocial model encourages researchers and medical staff to see the management
of patients' cognitions and expectations as a routine part of medical practice this can be
seen as legitimatising the manipulation of the information provided about prognosis,
treatment efficacy and recovery rates. There seems to be a belief that informed consent is
not required for this psychosocial treatment. It should not be surprising that presuming
certain groups of patients deserve to be manipulated in this way will be stigmatising,
and risks creating a culture of cynicism and distrust as knowledge of what has occurred
spreads.
The PACE trial shows the danger of allowing researchers with an interest in reporting
positive results to use subjective self-report outcome measures for a non-blinded trial.
While the more objective outcome measures from the PACE trial indicated that the
biopsychosocial interventions tested were not useful to patients, results were released in a
way which led to a range of excited claims being made about them leading to recovery for
patients.
In 2011 the chair of BACME, a professional organisation for those providing CBT and
GET to CFS patients, was the corresponding author on a paper which cited the PACE
trial to make the unjustifiable claim that:
"evidence from a recent evidence trial of cognitive behavioural therapy and

graded exercise therapy indicated a recovery rate of 30-40% one year after
treatment."[58]
During an interview promoting this paper she stated that she hoped it would be read by
the NHS commissioners who decide which services should be funded.[151]
Those who have built their careers upon the development and provision of
biopsychosocial interventions will have personal incentives to make exaggerated claims
about the value of their work, even if doing so risks distorting the beliefs and actions
of others and robbing patients of the ability to make informed decisions about the
treatments to which they are being asked to consent. The bold claims made by medical
researchers about the value of the biopsychosocial model of disability has allowed the
British state to claim authority over the psychosocial aspects of disabled people's lives,
and use their supposed expertise to justify cuts to disability welfare payments.
The biopsychosocial reforms, and the DWP's biopsychosocial disability assessments,
have also led to inaccurate claims about claimants being fit for work, and now we
have seen the culture of cynicism and distrust spread to others being affected by the
biopsychosocial model. The satirical response of a campaigning group to the assessments
carried out by Atos for the DWP, which routinely classed seriously sick and disabled
people as 'fit for work', could be equally applied to the claims made about recovery in the
PACE trial:
"Miracles are being wrought by the Sacred Tickbox at the Healing WCA Temples.
We want to share the news of these miracles that are being performed upon us!
Praise Be!"[152]
Atos Miracles
For a welfare system to be genuinely enabling for disabled people it needs to be founded
upon a reasonable understanding of disability, how it affects people, and the likelihood
of recovery. An unduly positive view of peoples' health problems, and the benefits of
psychosocial management and rehabilitation, can lead to policies which reduce disabled
peoples' control over their own lives and how they manage their health. Until the serious
33
and ongoing problems distorting medical research in this area have been overcome, it
is important to avoid assuming that civil servants and medical researchers have a better
understanding of how people with disabilities should live their lives than disabled people
themselves.
34
"IN THE EXPECTATION OF RECOVERY" | Appendix
Appendix
1. Selected criteria from the PACE trial
For ease of reference and comparison, some of the criteria referred to within the PACE
trial are provided here in full. The criteria laid out in the trial's 2007 protocol[37] are
consistently more demanding than those newly devised criteria for which results were
later released. The operationalised Oxford criteria for Chronic Fatigue Syndrome
used within the PACE trial is also included so that readers can better understand how
participants were selected.
From the PACE trial's published protocol[37]

ENTRY CRITERIA:
The participant meets operationalised Oxford research diagnostic criteria for CFS
[details of which are included beneath].
The participant's Chalder Fatigue Questionnaire score is 6 or more.
The participant's SF-36 Physical Function sub-scale score is 65 or less.
The participant agrees to randomisation and the terms of the trial.
OUTCOME MEASURES:
Primary Outcome Measures:

The 11 item Chalder Fatigue Questionnaire measures the severity of symptomatic
fatigue, and has been the most frequently used measure of fatigue in most previous
trials of these interventions. We will use the 0,0,1,1 [bimodal] item scores to allow
a possible score of between 0 and 11. A positive outcome will be a 50% reduction in
fatigue score, ora score of 3 or less, this threshold having been previously shown to
indicate normal fatigue.
The SF-36 Physical Function sub-scale measures physical function, and has often
been used as a primary outcome measure in trials of CBT and GET. We will count
a score of 75 (out of a maximum of 100) or more, or a 50% increase from baseline
in SF-36 sub-scale score as a positive outcome. A score of 70 is about one standard
deviation below the mean score (about 85, depending on the study) for the UK adult
population.
Those participants who improve in both primary outcome measures will be regarded
as overall improvers.
35
Recovery:
"Recovery" will be defined by meeting all four of the following criteria: (i) a Chalder
Fatigue Questionnaire score of 3 or less, (ii) SF-36 Physical Function score of 85 or
above, (iii) a CGI score of 1, and (iv) the participant no longer meets Oxford criteria
for CFS, CDC criteria for CFS or the London criteria for ME.
Outcome measures for which results were released

Primary Outcome Measures[20]:
Mean scores for Likert scoring of the Chalder Fatigue Questionnaire and the SF-36
Physical Functioning scale.
Participants who improved from baseline by two or more points for [Likert] fatigue
and eight or more for physical function. These were classed as being clinically useful
differences.
Within normal ranges for both primary outcomes/Back to normal/Recovered[20]:
A Likert fatigue score of 18 or less and an SF36-PF score of 60 or more.
Trial Recovery Criteria[45]:
36
Required i) a Likert fatigue score of 18 or less, ii) an SF36-PF score of 60 or more, iii) a
CGI score of under 2 and iv) not fulfilling the Oxford criteria for CFS*.
Clinical Recovery Criteria[45]:
Required i) a Likert fatigue score of 18 or less, ii) an SF36-PF score of 60 or more, iii) a
CGI score of under 2 and iv) not fulfilling the Oxford criteria for CFS*, CDC criteria for
CFS or the London criteria for ME .
* In the recovery paper, fulfilling the Oxford criteria required that patients have
a Chalder Fatigue Questionnaire score of 6 or more and a SF-36 Physical Function
sub-scale score of 65 or less. At baseline 235 patients were excluded from the trial
because they reported a SF36-PF score of over 65, separately from the 1011 excluded
for not fulfilling the Oxford criteria.[20] The entry criteria for the FINE trial, PACE's
sister trial, also required the Oxford criteria be fulfilled, but included patients who
had an SF36-PF score of 70, and a bimodal Chalder Fatigue score of 4. Patients who
fulfilled the most demanding recovery criteria used in the PACE trial could still have
fulfilled the Oxford criteria for FINE.[159]
Likert CFQ: mean (SD)
SMC
SMC+CBT
SMC+GET
SMC+APT
23.8 (6.6)
20.3 (8.0)
20.6 (7.5)
23.1 (7.3)
34
(50 to 18)
32
(48 to 17)
07
(23 to 09)
58.2 (24.1)
57.7 (26.5)
459 (24.9)
71
(20 to 121)
94
(44 to 144)
34
(84 to 16)
Mean CFQ difference

from SMC (95% CI)
SF36-PF: mean (SD)
50.8 (24.7)
Mean SF36-PF
difference from SMC
(95% CI)
'Back to normal'
15%
30%
28%
16%
Trial recovery
7%
22%
22%
8%
Clinical recovery
7%
21%
21%
8%
TABLE 2. Results for outcomes 12 months post randomisation
[20,45]
The Oxford criteria

This is a definition of chronic fatigue syndromes as laid out in A report-chronic fatigue
syndrome: guidelines for research:[24]:

A syndrome characterised by fatigue as the principal symptom

A syndrome of definite onset that is not life long
The fatigue is severe, disabling, and affects physical and mental functioning
The symptom of fatigue should have been present for a minimum of 6 months
during which it was present for more than 50% of the time
Other symptoms may be present, particularly myalgia, mood and sleep
disturbance
Certain patients should be excluded from the definition. They include: (i) Patients
with established medical conditions known to produce chronic fatigue (e.g. severe
anaemia). Such patients should be excluded whether the medical condition is
diagnosed at presentation or only subsequently. All patients should have a history
and physical examination performed by a competent physician and (ii) Patients
with a current diagnosis of schizophrenia, manic depressive illness, substance
abuse, eating disorder or proven organic brain disease. Other psychiatric disorders
(including depressive illness, anxiety disorders and hyperventilation syndrome) are
not necessarily reasons for exclusion.
37
From the PACE trial's full protocol:[22]

ASSESSMENT OF OXFORD CRITERIA FOR CFS:
Questions for which patients must answer 'yes':

Is your fatigue (or a synonym), the principal (main, primary) symptom (e.g.
tiredness, lack of energy, weariness, exhaustion)?
For the Research Nurse to judge: Can the fatigue be distinguished from low mood,
sleepiness and lack of motivation?
Is your fatigue out of proportion to what you would expect as normal for this level
of exertion?
Is your fatigue a clear change from how you were previously?
Did your fatigue start with a definite onset (which may be gradual)?
Have you had your fatigue for the last 6 months, during which it was present for
more than half of the time?
Does your illness affect both your physical ability and mental functioning
(thinking, concentrating, talking, reading or remembering)?
Questions for which patients must answer 'no':

Have you had this fatigue all your life, as far as you can remember?
38
Medical exclusions:
Established medical conditions known to produce chronic fatigue (see medical
screening SOP). RN to check that this has been done and documented by the clinic
doctor.
Psychiatric Exclusions:
Schizophrenia, Manic depressive (bipolar) illness, Substance misuse, Eating disorder,
Proven organic brain disease.
Other psychiatric disorders (including depressive illness, anxiety disorders, and
hyperventilation syndrome) are not reasons for exclusion.
The changes from the outcome criteria laid out in the trial's 2007 protocol[37] consistently
served to make it easier to report positive results, and this will have served to inflate
the claims that could be made about the benefits of treatments. While the PACE team
continue to fight against the release of results for the criteria which they themselves had
devised for their published protocol we cannot know exactly how great an impact these
protocol changes will have had.
2. Patient expectations and the danger of bias

We cannot know that problems with bias explain why patients in the CBT and GET
groups reported greater improvements for the trial's subjective outcomes compared to
the more objective outcome measures used. It had been suggested that in fact, problems
with bias could have adversely affected the results reported for CBT. Before they began
treatment patients were asked about their views on the therapy that they were due to
receive (Table 3), and as patients were less confident about CBT than APT, it could be
argued that we need not be concerned about the danger of results for subjective selfreport measures being biased in favour of CBT over APT.
Adaptive
Cognitive
pacing therapy behaviour
(n-159)
therapy
(n=161)
Graded
exercise
therapy
(n=160)
Specialist
medical care
alone (n=160)
Treatment is
logical
134 (84%)
115 (71%)
135 (84%)
79 (49%)
Confident
about
treatment
114 (72%)
91 (57%)
112 (70%)
65 (41%)
TABLE 3. Participants' views before treatment.[20]
However, as part of both CBT and GET patients were told that their treatments had
already been shown to be effective (e.g. from the CBT participant's manual: "Cognitive
behaviour therapy (CBT) is a powerful and safe treatment which has been shown to be
effective in a variety of illnesses, including CFS/ME, headaches and back pain."[35]) and no
equivalent claims were made as a part of APT. Receiving these claims from clinicians in
positions of authority during treatment may have affected patient beliefs and expectations
in a way which biased results. Furthermore, the models of illness provided as a part
CBT and GET were likely to encourage patients to believe that they had greater control
over their symptoms, and that a failure to improve would reflect poorly upon their own
efforts. There is a danger that simply promoting these models of illness to patients would
encourage them to report their symptoms more positively.
APT was a therapy devised for the PACE trial and unlike the pacing most commonly
used by patients, which is self-learned, is taught and supervised by a therapist.[154] It was
stated that this was done in order to reduce to danger of bias distorting results: "Given
that having a sympathetic therapist usually influences the success of a therapy, having
two parts of the trial supported by a therapist but one not, would have risked not giving
pacing a fair chance."[154]
This early awareness that the PACE trial was designed in such a way that the primary
outcomes could be so easily distorted seemed to have faded away by the time results were
being presented to the media.
The PACE team published the following graph, showing results for an objective
measures of fitness[44], but have refused to release the exact figures for this data, classing
a request for this information as vexatious.[76] Therapists providing APT were told that an
important consideration in APT is the 70% rule: never going beyond 70% of a person's
perceived energy limit[35], while those providing CBT and GET encouraged patients to
39
gradually increases activity.[35] This did not seem to lead to the differences in patients'
fitness levels that one might expect.
FIGURE 2. Results of the PACE trial's four groups' fitness results
40
We cannot be confident in any interpretation of the primary outcomes for the PACE trial.
There are reasons that they could have been biased for or against any of the treatment
groups. It is important that these problems with interpreting results are acknowledged
when they are being presented, and that results for the trial's more objective outcome
measures are provided in addition to those for the SF-36 Physical Functioning Scale and
Chalder Fatigue Questionnaire.
3. Primary trial outcomes

The SF-36 Physical Functioning Scale and Chalder Fatigue Questionnaire served as the
PACE trial's primary outcomes.[22] Being aware of the specifics of these questionnaires
and how they are scored encourages a better understanding of what those scores truly
represent.
For the SF-36 Physical Functioning Scale people are asked, for ten activities, "does your
health limit you in these activities? If so, how much?"
People are scored depending on which of three answers they choose:
Yes, limited a lot (0)
Yes, limited a little (5)
No, not limited at all (10)
The 10 activities of SF36-PF are:

1. Vigorous activities, such as running, lifting heavy objects, participating in strenuous
sports.
2. Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling or
playing golf.
3. Lifting or carrying groceries.
4. Climbing several flights of stairs.
5. Climbing one flight of stairs.
6. Bending, kneeling or stooping.
7. Walking more than a mile.
8. Walking several blocks.
9. Walking one block.
10. Bathing or dressing yourself.
For the Chalder Fatigue Questionnaire people are told:
"We would like to know more about any problems you have had with feeling
tired, weak or lacking in energy in the last month.... If you have been feeling tired
for a long while, then compare yourself to how you felt when you were last well."
People are scored depending upon which of the four answers that they choose and the
scoring method used.
Less than usual
No more than usual
More than usual
Much more than usual
(Likert scoring: 0
(Likert scoring: 1
(Likert scoring: 2
(Likert scoring: 3
Bimodal scoring: 0)
Bimodal scoring: 0)
Bimodal scoring: 1)
Bimodal scoring: 1)
The eleven questions used are:

1. Do you have problems with tiredness?
2. Do you need to rest more?
3. Do you feel sleepy or drowsy?
4. Do you have problems starting things?
5. Do you lack energy?
6. Do you have less strength in your muscles?
7. Do you feel weak?
8. Do you have difficulty concentrating?
9. Do you make slips of the tongue when speaking?
10. Do you find it more difficult to find the correct word?
11. How is your memory?
The PACE team had classed the bimodal scoring of the Chalder Fatigue scale as the trial's
primary outcome.[37] Before the PACE trial's results were released its sister trial, FINE[153],
released results without deviating from its protocol and reported that biopsychosocial
rehabilitation did not lead to an improvement in the trial's primary outcome compared
to a 'treatment as usual' control. They also reported that had they used Likert rather than
bimodal scoring for the Chalder fatigue scale then a small but statistically significant
41
improvement could have been reported. The PACE team have decided to only release
results for Likert scoring of the Chalder Fatigue scale.
The trial's post-hoc recovery criteria uses Likert scoring, making it slightly more
difficult to compare to the original criteria for recovery and entry to the trial, both of
which used bimodal scoring. Within the main report's discussion of the changes to
criteria, the original boundaries for the bimodal score were converted to Likert scoring,
while the full original criteria are outlined above.
4. Exaggerated positive claims

"Information and advice should be evidence-based, accurate, and realistic; but it
should also be positive - encouraging and supporting restoration of function and
return to work."
Waddell and Burton[19]
When there is a willingness to tolerate a systematic 'positivity' in the way information in

presented distortions can grow and spread. Here is an example how exaggerated claims
about the results from the PACE trial became more extreme within the peer-reviewed
scientific literature as researchers misunderstood one another's claims in ways that served
their own interests.
42
1. In the 2011 PACE paper researchers reported results for those who were "within
normal ranges for both primary outcomes at 52 weeks"[20]: 15% (SMC), 30%
(SMC+CBT), 28% (SMC+GET) and 16% (SMC+APT). Patients could have entered the
trial being classed as suffering from fatigue which was "severe, disabling and affects
physical and mental functioning", reported a worsening of their fatigue and physical
functioning following treatment, and yet still have fallen within the PACE team's
post-hoc normal ranges for fatigue and physical function.
2. To the press and to patients the PACE team described these patients as being "back to
normal" and stated that "the number of patients returning to normal levels of fatigue
and physical function was about three out of ten after CBT or GET; about twice as
many as those who received APT or SMC."[59,60]
3. In a commentary in The Lancet that accompanied the publication of the PACE paper,
and was reviewed and approved by the PACE team, it was stated that: "PACE used
a strict criterion for recovery: a score on both fatigue and physical function within
the range of the mean plus (or minus) one standard deviation of a healthy persons
score. In accordance with this criterion, the recovery rate of cognitive behavioural
and graded exercise therapy was about 30%although not very high, the rate is
significantly higher than that with both other interventions."[54] It was not true that
PACE had used healthy people's score to derive their normal range and it is difficult
to see how a 'strict criterion for recovery' could overlap with the trial's own entry
criteria.
4. Those reporting on the PACE trial continued to promote the claim that about one
third of patients had recovered with CBT and GET, with the BMJ reporting that "Less
than a third of patients were cured by either treatment (30% (44/148) after CBT and
28% (43/154) after graded exercise therapy)."[52,55-57]
5. In a column for The Telegraph, which has since received some alterations, Max
Pemberton wrote that: "The current gold standard for treatment is a combination of
supervised exercise and talking therapies. A major British trial published in The Lancet
found that at least one in three patients with ME recovered using this approach. The
biggest hurdle faced by doctors is persuading people to actually attend and engage
with treatment. They resist because they refuse to be seen as mentally unwell. It
does seem bizarre that those with such a debilitating disease would refuse treatment
because it was given by a psychiatrist."[56]
6. In a paper on the impact and costs of CFS/ME the PACE trial was cited to support
the claim that: "Evidence from a recent evidence trial of cognitive behavioural
therapy and graded exercise therapy indicated a recovery rate of 30-40% one year
after treatment."[58] The corresponding author for this paper was Esther Crawley,
chair of BACME, a professional organisation for those providing CBT and GET to CFS
patients, and she stated that she hoped that this paper would be read by the NHS
commissioner who decide which services should be funded.[151]
There is a danger that even more extreme misrepresentations of the evidence are made
behind closed doors. If politicians and NHS commissioners assume that they can
trust the claims being made in peer-reviewed medical papers then they are likely to be
making many important decisions based upon a seriously distorted understanding of the
evidence.
5. Informed consent
Even when randomised controlled trials are rigorously conducted and appropriately
reported their results may still be misleading and differ from those seen outside of a
research setting. Those patients selected for entry in to a trial may not be representative
of the patient population, and volunteering for participation shows that these patients
are happy to take part in the trial's treatments, so results cannot be used to claim that
the forced treatment of others would be beneficial. Patients and therapists who know
that they are being assessed as part of a trial may behave and respond differently to
those outside of trials. Medical trials can also feature higher levels of supervision and
oversight during treatment than those seen elsewhere, potentially leading to greater care
and attention and therefore improved results. It is important that people are aware of
the limitations which surround even relatively robust medical knowledge, that patients
are made aware of these limitations before being asked to consent to treatment, and that
systems are in place to ensure patient concerns about the treatments they receive outside
of trials are listened to.
Information on treatment effects and patient satisfaction has been collected by those
providing CBT and GET to CFS patients and by patient charities.[155-157] Results from
patient surveys are likely to be skewed by the self-selection of those who complete them,
who are unlikely to be representative of the general patient population. There are other
potential problems with such evidence too, such as a lack of independent confirmation
of a patient's diagnosis, or the possibility that the treatment they received had not been
provided properly. While results from surveys conducted by patient charities need to
be treated with caution, they do provide an opportunity for patient voices to be heard
without being filtered through researchers and medical staff. Perhaps unsurprisingly,
43
those providing CBT and GET to patients tend to report more positive findings for their
interventions than patient groups, which routinely report that many patients found CBT
and GET to be harmful.[155-157]
A recently released report from one charity included patient statements which could
help explain the discordancy of results: "They taught us positive mental attitude, so it was
impossible to report back the truth without being accused of negativity."[157] This sort of
attitude can also be seen in the medical literature. For example, therapists from PACE's
sister trial, FINE[153], found that dealing with patients after they had been trained to
provide biopsychosocial rehabilitation was frustrating.
This was illustrated by the quote:
"The bastards dont want to get better".[158]

As a part of the FINE trial therapists had been trained to provide positive "rousing
reassurance" such as:
"From the moment you walk out of this room your recovery is beginning.
There is no disease
Go for 100% recovery"[159]
44
If people are encouraged to believe that patients' health problems are entirely reversible
though rehabilitation, then their failure to recover is likely to lead to irritation.
Genuinely informed consent requires that the claims made to patients are not shaped
by a desire to be positive or reassuring. A course intended to reduce unemployment
which leaves the unemployed reporting greater confidence in their ability to find work,
but does not lead to real improvements in employments rates could be a harmful waste
of time and resources, and should not be sold as helping people to get back to work. A
non-blinded trial of a medical intervention which enables patients to report less disabling
fatigue on questionnaires but not increase their activity levels or show other more
objective evidence of improvement should not be sold as an evidence-based treatment for
disabling fatigue. It is important to be clear about the problems with relying upon selfreport measures in non-blinded trials, and the danger that results for these outcomes may
be misleading.
6. Recent developments
Since this report was first submitted for publication, there have been a number of
interesting developments that I will attempt to briefly summarise here, as well as
providing references to further reading.
First, David Tuller, a science journalist and academic coordinator of the concurrent
masters degree program in public health and journalism at the University of California,
Berkeley, began publishing a series of lengthy investigative pieces detailing problems
with the PACE trial.[160,161] Some of these problems have been covered within this
report, but many were not. His pieces included criticism of PACE from a number
of prominent researchers, who then went on to write an open letter expressing their
concerns to Richard Horton, editor of The Lancet, arguing that such flaws have no place
in published research.[162] Following Horton's failure to respond, the letter was re-sent,
with an additional thirty six signatories.[163] Following publication of a piece by Tuller on
problems with the PACE trial researchers' conflicts of interest involving the insurance
industry, Swiss Re removed from its website one of the pages cited in this report.[164,165]
Fortunately this page had been backed up and made available elsewhere.[97]
Soon after David Tuller had published his first piece a new PACE trial paper was
published, providing mean Chalder Fatigue scale scores and SF-36 Physical Functioning
scores for the trial's treatment groups at 2.5 year follow up.[166] These results showed that
patients randomised to receive CBT and GET in addition to Specialist Medical Care
reported scores no better than those randomised to Specialist Medical Care alone.
In a press release promoting CBT and GET titled 'Treatments offer hope for Chronic
Fatigue Syndrome (CFS/ME)' one of the PACE trial's researchers argued that:
"We found that participants who had originally been given SMC or APT
appeared to be doing as well as those who had CBT or GET in the longer term.
However as many had received CBT or GET after the trial, it does not tell us that
these treatments have as good a long term outcome as CBT and GET."[167]
This is true, yet within the paper's appendix is data which had been included at request
of a reviewer which showed that the scores of those participants randomised to the SMC
or SMC+APT groups who received no additional treatment improved by as much as the
scores of those who received additional CBT or GET. The press release did not mention
this evidence.
At 2.5 years follow-up the additional therapies provided had broken randomisation and
made it difficult to claim anything with confidence. That did not prevent the researchers
presenting results in a way which led to a front page article in The Daily Telegraph which
began by claiming that:
"Chronic Fatigue Syndrome is not actually a chronic illness and suffers can
overcome symptoms by increasing exercise and thinking positively, Oxford
University has found."[168]
The headline was Exercise and positivity 'can overcome ME'.
David Tuller's work, and problems with the way result for this new paper were
presented, served to draw the attention of further academics, including James Coyne and
Keith Laws, two researchers known for their attempts to raise standards within mental
health research.[169,170] In a co-authored response titled Results of the PACE follow-up study
are uninterpretable they criticised the way in which previous concerns about the PACE
trial had been responded to:
"the PACE investigators have previously complained in The Lancet Psychiatry of

the apparent campaign to bring the robust findings of the trial into question.
We think the further scrutiny that the follow-up study has brought casts further
doubt on whether there ever were robust findings. The investigators should
get more accustomed to rigorous post-publication peer review, which is not a
campaign, but a reality of the 21st century."[171]
45
Meanwhile, the Information Commisioner's Office released a decision notice that ordered
the release of anonymised data from the PACE trial which would allow for the calculation
of results for many of the outcomes laid out in the trial's protocol, including their original
recovery criteria.[75,172] The decision notice reveals the range of arguments Queen Mary
University of London attempted to use to avoid the release of this data; including that the
data release could contravene confidentiality agreements given to participants as, even
though no plausible way third parties could re-identity participants was provided, they
raised the concern that the participants themselves might be able to identify their own
data, somehow potentially breaching their own confidentiality. Rather than releasing
the requested data Queen Mary decided that they would prefer to appeal against the
Information Commissioner's decision, and a three day tribunal hearing is now due to
take place over 20-22 April 2016.[173]
A separate refusal to release data from the PACE trial then attracted wider attention
from the scientific community.[174] An earlier PACE paper had been published in
a scientific journal, PLOS ONE, that requires authors make data available to other
researchers (the data used for this paper would not allow for the calculation of results
for the recovery criteria laid out in the trial's protocol). James Coyne requested this data,
and the PACE team's refusal to honour their commitment to data sharing drew the ire
of a wide range of campaigners concerned about problems with the reliability of medical
research, leading to yet further requests for access to this data.[175, 176]
The refusal letter argues that:
46
"the active campaign to discredit the project has caused distress to the
universitys researchers who hold legitimate concerns that they will be subject to
public criticism and reputational damage."
Such concerns should not be allowed to interfere with the critical assessment of
scientific research. PLOS has now issued an editor's note stating that:
"several readers have raised concerns regarding the analyses reported in this
article. We are also aware that there have been requests for the data from this
study"
and concluding:
"As part of our follow up we are seeking further expert advice on the analyses
reported in the article, and we will evaluate how the request for the data from
this study relates to the policy that applies to the publication. These evaluations
will inform our next steps as we look to address the concerns that have been
noted."[177]
Coyne has claimed that he and PLOS had:
"come under pressure from a number of sources, including Richard Horton,

editor of the Lancet"
and suggested that:
"this is emerging as a major, maybe historic confrontation between the forces

pushing for sharing of data and the British establishment".[178]
A recently released report provided some information on a 2015 conference at the Royal
Society where criticism of the PACE trial, and the Freedom of Information requests it
attracted, were presented as an exogenous threat to science.[179]
Since the release of the first PACE paper the Science Media Centre, an organization
which has considerable influence over how the UK media report science stories, has
played an important role in the promotion of the PACE trial and the exaggeration of
its results, while critics were portrayed as misguided, unreasonable and perhaps even
dangerous.[72, 74, 145, 180-185] It has also played a role in attempting to aid efforts by Peter
White, a principal investigator for the PACE trial, to secure further restrictions to the
Freedom of Information Act in relation to research data. Correspondence from White
forwarded on by Fiona Fox, director of the Science Media Centre, requested academics
ask their own Universities, and other lobbyists, to get in touch with friendly Members of
Parliament in order to argue for a weakening of the Freedom of Information Act.[186] Peter
White's personal submission to the recent Commission on Freedom of Information is
also publicly available.[187]
He argued that:
"we need science in the UK to be protected or it will continue to be damaged as

this [PACE] trial has been (other examples include climate change science, and
research into the health effects of tobacco). Exempting Universities from the FOIA
would achieve that. Exempting scientific research data produced by Universities
and other higher educational institutes might be a workable alternative."
An earlier restriction to the Freedom of Information Act (exemption 22A) has already
been presented by the PACE team as one the beneficial outcomes of the PACE trial.[188]
Considering the many problems with the way the PACE trial was designed, conducted
and then presented, it is not surprising that Peter White was keen to avoid the scrutiny
that the Freedom of Information Act can assist.
Following the attention attracted by the refusal to release data from the PACE trial a
statement was released by the PACE team which reported that they are:
"currently seeking further ethical and scientific advice, as well as the advice of
patients, on how best to provide independent decisions about appropriate access
to relevant data".[189]
In response to this a string of major ME/CFS patient organisations from around the
world have written to Queen Mary arguing for the release of the requested data, including
Action for ME, the patient charity which had been involved in assisting with the trial.[190,
191]
Over twelve thousand signatures have also been collected for a patient petition calling
for the correction of misleading claims made within PACE trial papers and the release
of results for the recovery criteria laid out in the trial's published protocol.[192] So far, this
advice from patients does not seem to have led to Queen Mary abandoning their appeal
47
48
to the Information Tribunal. While concerns have been expressed about protecting
the personal data of trial participants, no explanation has been provided as to how the
limited data request Queen Mary is appealing against could lead to the identification of
participants. The closest we have seen is a vague reference to it being a 'very rich' data
set by Simon Wessely, President of the Royal College of Psychiatrists.[193] Sir Simon has
also offered an attempted defence of the PACE trial in a blog post, however he failed
to address the central concerns raised by the trial's critics, and he raised no points that
required changes to be made to this report.[194]
Since submitting this report awareness of the problems which surround the PACE
trial, and criticism of it, has grown dramatically.[161,169,170,195-198] Yet this change has largely
occurred outside of the UK, while British reporting of the controversies around the PACE
remains less well informed and seemingly more readily affected by the prejudices which
can surround CFS.[168,199-202] The PACE trial illustrates concerns about British medical
research, politics and also science reporting and the role of the Science Media Centre
in shaping public discourse. In parts of the British media it appears to have become
fashionable to use CFS and the controversy surrounding the PACE trial as a justification
for inane commentary on the problems of a dualistic understanding of body and mind,
ignoring the real problems with biopsychosocial approaches to CFS and the prejudices
that poorly researched work can promote.[56, 72, 199,200 202-205]
While recent developments have brought more attention to the problems with the
research at the centre of this report, we are still waiting for real progress to be made in
correcting these problems. It should not be assumed that the PACE trial is a uniquely
flawed piece of research, but it does serve as a useful case study for the political dangers
of poor quality medical research, and the harm it can do. It also helps illustrate problems
within the systems of science, that too often seem designed to serve the interests of
researchers and those in positions of authority rather than society at large. While there
are signs of some improvements to these systemic problems, progress is slow, and
the PACE trial indicates how committed some are to protecting their own privileged
positions. We must now wait to see if the Information Tribunal refuses Queen Mary's
appeal, in which case we may soon have access to data that could help correct some
of the misleading claims made about the PACE trial and the expectations patients can
reasonably hold about recovery.
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The Centre for Welfare Reform

The Centre for Welfare Reform is an independent research and development
network. Its aim is to transform the current welfare state so that it supports
citizenship, family and community. It works by developing and sharing social
innovations and influencing government and society to achieve necessary reforms.
To find out more go to www.centreforwelfarereform.org
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Relevant Publications
CITIZENSHIP AND THE

WELFARE STATE
In this short philosophical monograph
Simon Duffy explores the role of
citizenship in the definition and
defence of the welfare state.
http://bit.ly/citizen-roots
A FAIR SOCIETY?
This report explains how government
cuts in the UK target disabled people
and offers explanations for the
underlying politics.
http://bit.ly/afscuts
PEOPLE, PLACES,
POSSIBILITIES
In this report Ralph Broad outlines
the progress made in implementing
Local Area Coordination in England and
Wales between 2012 and 2015.
http://bit.ly/LAC-2
WHO CARES?
Robin Jackson offers a critique of
the UK's social care system and
the negative impact of ideology,
marketisation and bureaucracy.
http://bit.ly/care-crisis
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In The Expectation of Recovery

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"In the Expectation of Recovery"

MISLEADING MEDICAL RESEARCH AND WELFARE REFORM

About the author:

The Politics of Distorted Research . . . . . . . . . . . . . . . . . . . . . 22

Research Distorted by Politics . . . . . . . . . . . . . . . . . . . . . . . . 26

A REPORT FROM THE CENTRE FOR WELFARE REFORM