The involvement of the PACE Trial Principal Investigators and the Director of the Clinical Trials Unit with the Department for Work and Pensions
by Margaret Williams
31st March 2011
Following publication of
the PACE Trial results and mindful of the fact that the Department for Work and
Pensions (DWP) was a co-funder of the trial, it may be salutary to reflect
afresh on the involvement of Principal Investigators Professors Peter White and
Michael Sharpe and the Director of the Clinical Trials Unit (Professor Simon
Wessely) with the DWP.
The extracts below are from
recent DWP/Atos Healthcare Training Programmes for medical practitioners
carrying out assessments on State benefit claimants with ME/CFS.
They graphically
illustrate the pervasive influence of the Wessely School’s beliefs about ME/CFS
at the Department for Work :
“not to answer a question, but in order to
demonstrate a pre-required answer”
(Why most published research findings are false. J.Ioannidis; PloS
Medicine 2005:2:8:e124 – note that this article by Ioannidis is the
most down-loaded in the journal’s history).
MEDICAL SERVICES provided on
behalf of the Department for Work and Pensions
Training and Development: Continuing Medical Education
Programme: Chronic Fatigue Syndrome – Guidelines for the Disability Analyst
Version 4; April 2009. Updated by
Dr Peter Ellis. Version 1 written by Dr Tony Fisher.
“The authors and Medical
Services gratefully acknowledged the contribution of the authors (Professor S
Wessely, Professor PD White and Professor M Aylward) of the enclosed
articles and their kind permission to reproduce them in this module.In
addition the author would like to express his gratitude to Dr P Dewis for his
helpful comments and suggestions”.
For more information on
Professor Mansel Aylward and his stance on ME/CFS, see pages 428 ff at
click here.
Together with (then) Dr
Aylward, Dr Peter Dewis from the Disability Living Advisory Board authored the
Disability Handbook before Dewis became Chief Medical Officer at UNUMProvident
in July 2000 after 16 years at the Department of Social Security (now the DWP).
In 2002, Dewis wrote about the patients whose claims management posed
difficulties for UNUMProvident; in the company’s Report “Trends in Health and
Disability”, he stated:
“I
have commissioned a number of papers from leaders within the
medical profession whose disciplines are particularly relevant to
those people…whose claims most frequently pose us difficulties in
their management.
“A paper
from Michael Sharpe has reviewed the developments, not only in
chronic fatigue syndrome, but also the range of disorders where the
symptoms experienced by individual patients appear to be out of
proportion with the physical findings or objective evidence of
disease.
“Mansel Aylward who is
Chief Medical Adviser to the Department of (sic)
Work and Pensions has set out the current trends in government
strategy relating to both health and social security.
“My intention would be for
this report to be repeated on an annual basis and so become an
authoritative and informative document on the current state of
medical thinking on those issues which are of greatest importance to
us.
“Dr Lipsedge (and) Dr
Sharpe have identified the importance of cognitive behaviour therapy
of (sic) influencing the outcome in
…chronic fatigue syndrome. This again represents a challenge
in ensuring that people are directed towards this approach”.
Thus the interest of the
DWP and the insurance industry in ME/CFS is clear: it is a disorder that poses
“difficulties” for them, so it seems it must be “eradicated”, preferably by
those who already work for these agencies. It appears that it is those
commercial interests, not the plight of sick people, which are paramount. It
also seems that, as part of the triple strategy of the “CFS” clinics and the
NICE Clinical Guideline on “CFS/ME”, the PACE Trial was the ideal vehicle to
remove the “difficulties”.
Extracts from the DWP
Medical Services Training and Development on Chronic Fatigue Syndrome
Guidelines:
“This training has been
produced as part of a Continuing Medical Education programme for
Health Care Professionals (HCPs) approved by the Department for Work
and Pensions Chief Medical Adviser to carry out assessments”.
“…it must be remembered that
some of the information may not be readily understood without
background medical knowledge and an awareness of other
training given to Health Care Professionals”.
“The series is
designed to encourage consistency in our approach to complex
conditions, provoke reflection on our own perception with
regard to them, and foster awareness of current medical
thinking” (ie. the Wessely
School’s thinking).
“Chronic fatigue syndrome (CFS) is a disorder, or group of
disorders, which continue to cause considerable difficulties for
clinician and disability analyst alike(no mention of difficulties caused to
patients). Since the terms ‘myalgic
encephalomyelitis’ and ‘post-viral fatigue syndrome’ both carry
implications relating to causation, the generic term CFS is
preferred”.
“The purpose of this
module is to encourage Health Care Practitioners working in
disability analysis to adopt a common approach to this difficult
and complex illness”.
In the first
self-assessment exercise, Medical Services assessors are instructed to read the
questions and then tick one of the boxes, one of the questions being: “Most
cases of chronic fatigue [sic] are attributable to abnormal
illness behaviour”. “Chronic fatigue” is not the same as “CFS/ME”, but
even if applied to “chronic fatigue”, this is a Wessely School assertion that is
not supported by clinical evidence: when carefully examined and diagnosed,
patients with many organic illnesses have chronic fatigue, including patients
with cancer, COPD, thyroid disease, multiple sclerosis, Parkinson’s Disease,
liver disease, TB, and many viral illnesses, none of which disorders can be
categorised as “abnormal illness behaviour”.
The training
programme then presents a case study:
“Mrs D is a
42-year old woman. You have been asked to assess her and provide a report for a
non-medical decision maker. She has completed a claim form herself, amplifying
it with several additional pages of hand-written text and a pamphlet describing
features of ‘ME’ ”.
Such loaded wording
immediately introduces denigration, disparagement and bias into the training
programme for DWP assessors.
The Guidelines for DWP
assessors state that anhedonia (loss of any pleasure/interest in life) is
commonly present in CFS, which is erroneous, as it is not present in
ME/CFS. In 1991, John Wiley & Sons published “Post-Viral Fatigue Syndrome”
edited by Professors Rachel Jenkins and James Mowbray; in her own contribution,
Professor Jenkins, a Principal Medical Officer at the Department of Health and
Director of the WHO Collaborating Centre for Mental Health at the Institute of
Psychiatry, made it clear on page 242 that there is no anhedonia in ME.
The DWP Training Guidelines
on CFS continue:
“At one end of the scale are the (uncommon) cases where
there is a very clear history of the sudden onset of fatigue after a proven
viral infection, such as Epstein Barr virus; at the other, cases strongly
associated with current or pre-existing psychiatric disorder. In fact, most
patients with CFS will also meet the criteria for a current psychiatric disorder”
(citing Simon Wessely and Trudie Chalder).
“From the point of view of the
disability analyst, by the time an individual has reached the stage
of requiring a functional assessment the diagnosis is likely to have
been in place for some time and behaviour patterns firmly
established in the minds of the claimant and his medical attendant”.
The claimant’s medical
attendant may be entirely correct in his/her management, but this implied
criticism has long been a feature of the Wessely School’s dismissal of “naive”
clinicians who do not subscribe to their own beliefs about ME/CFS: for example:
“Suggestible patients
with a tendency to somatise will continue to be found among sufferers from
diseases with ill-defined symptomatology until doctors learn to deal with them
more effectively….It has been shown (by whom?) that some patients have
always preferred to receive, and well-meaning doctors to give, a physical rather
than a psychological explanation…such uncritical diagnoses may reinforce
maladaptive behaviour” (Old wine in new bottles: neurasthenia and ME. Simon
Wessely. Psychological Medicine 1990:20:35-53) and “The prognosis may
depend on maladaptive coping strategies and the attitude of the medical
profession” (The psychological basis for the treatment of CFS. Wessely S.
Pulse of Medicine, 14 December 1991:58).
The DWP Guidelines
continue:
“It will almost always be
appropriate to assess the claimant’s mental state, and in the case
of IB PCA (Incapacity Benefit Personal
Capability Assessment) and ESA (Employment and Support
Allowance), to complete a mental
health/function assessment”.
“The combination of
cognitive behavioural therapy (citing
Wessely and Chalder) and graduated exercise (citing Peter
White) is at present the mainstay of treatment”, “treatments”
which have been shown to be ineffective in numerous international
reports and in surveys carried out by ME/CFS charities, as well as
in the UK FINE and PACE Trials themselves.
The Training Programme then
instructs DWP assessors to read only a heavily psychiatrically biased reading
list (with no mention of any of the biomedical evidence on ME/CFS), including
“Occupational aspects of the management of Chronic Fatigue Syndrome: A National
Guideline” (2006) in which Professors White, Sharpe and Chalder were
instrumental; the NICE Guideline CG53 (2007) which recommends only CBT/GET as
the primary intervention, and the 1996 report on CFS of the DWP Chief Medical
Adviser’s “Expert Group” which included Dr John LoCascio (Medical Director of
UNUMProvident insurance company), Professor Anthony Pinching, Dr Peter White,
and Dr Charles Shepherd, (Medical Adviser, ME Association).
This “Expert Group” advised
that: “The Chief Medical Adviser (at that time, Dr Mansel Aylward)is very anxious to ensure consistency of medical advice which is based
on the prevailing consensus of informed expert opinion on this subject
(ie. on the advice of Simon Wessely, Peter White and Michael Sharpe, again with
no mention of the substantial biomedical evidence-base). “The following
interests and disciplines were represented: academic research into CFS, clinical
interest in the field (from psychiatry, neurology, infectious diseases and
general practice), occupational medicine, the insurance industry…and the
Disability Living Allowance Board”.
Key recommendation of
this “Expert Group” were: “The sooner appropriate management was started, the
better the prognosis” and “Activity should be
increased in a managed, step-wise manner”.
The “Expert Group” agreed
that: “Recovery should not necessarily be equated as getting back to the
same condition as before the illness” (which seems to be a portender of
the PACE Trial results). “Recovery” is defined in The Penguin English
Dictionary as “To regain health after sickness”, which means restoration
of full health after sickness; the term “recovery” is not open to idiosyncratic
interpretation by the DWP or its “Expert Group”.
The “Expert Group”
recommended that its report to the DWP’s Chief Medical Adviser should be widely
available to all those with an interest in CFS (ie. throughout the NHS).
At the end of the
Training Programme, assessors were asked to tick more boxes and informed that “If
the objectives have been achieved, you should have no difficulty in responding
correctly”: one of the tick-box choices was: “The
combination of cognitive behavioural therapy and antidepressants should be the
mainstay of treatment”.
The signed, completed form
(together with the person’s GMC or NMC registration number) was to be returned
to the “Medical Manager at your Medical Services Centre”.
The 2010 version
The Foreword to the
DWP Medical Services 2010 version (Training and Development: Chronic Fatigue
Syndrome [CFS] and Fibromyalgia Learning Set Continuing Medical Education)
states: “The training has been produced as part of a
Continuing Medical Education programme for Health Care Professionals (HCPs)
approved by the Department for Work and Pensions to carry out assessments”.
For the DWP Medical
Services to conflate “CFS” and fibromyalgia is in breach of the WHO ICD-10
classification which classifies FM as a separate disorder from “CFS/ME” at M79.
This version is
particularly prescriptive and has become even more didactic: it ensures that
only one message about ME/CFS and FM (the Wessely School’s message) is
delivered and received:
“A Learning Set is
dedicated to the sharing of team knowledge, and must be conducted
using internal sources only. External speakers are not acceptable
at these events”. (This is knowledge
control, which is unacceptable ethically, morally and academically).
“This Learning Set is designed
to encourage competency based on the subject of CFS and FM and the
functional effect of these conditions on the claimant”.
“The learning aims are defined
and the ‘manager’ of the Learning Set is encouraged to ensure that
these are kept prominently to the fore-front throughout the event,
keeping them in view of all participants”.
“The only absolute givens are
that the essential content is adhered to and the Learning Set aims
achieved”.
There is a
requirement to ensure that “verification of the
learning aims have been satisfied”.
Although nominally a
DWP Training and Development Programme for assessors, the DWP Medical Services
Guidelines state: “It is also necessary to demonstrate
that the outcomes of the Learning Set satisfy the requirements of the Continuing
Professional Development Programme for Atos Healthcare”.
This sounds disturbingly
like cult indoctrination and it is little wonder that so many people with ME/CFS
report that their assessment(s) by DWP and Atos-trained assessors are traumatic
experiences.
In February 2011, the BMJ
published an article by Margaret McCartney about Atos Healthcare (Well enough to
work? Increasing numbers of people previously deemed medically unfit to work are
being taken off state benefits after assessments by a doctor. BMJ
2011:342:d599).
McCartney’s article
was enlightening: Atos Healthcare is a
“French information
technology firm, which is subcontracted to the Department for Work
and Pensions to provide work capability assessments. In
November last year (2010)
Atos announced a three year extension to its contract with the
department, worth £300 million, to ‘support the UK government’s
welfare reform agenda’. Atos is the sole contractor….A quick
glance at internet discussion forums suggests widespread
dissatisfaction from people who have been assessed”.
“The
adverts for Atos, however, consist of a smiling, badged professional
saying, ‘Getting home on time has become part of my daily routine’.
The lack of on-call duties and the 9-5 office hours were also the
major advantage plugged at the evening, where nurses and doctors
working for Atos helped to promote joining the company”.
From her attendance at an
Atos recruitment evening, McCartney reported:
“The
message from the recruitment evening was quite clear. We were told:
‘You are not in a typical caring role….We don’t call them
patients…We call them claimants’. Training is provided for each type
of benefit examination. Its length…depends on experience but is
generally up to five days of classroom training, followed by
sessions accompanied by a trainer that are audited afterwards”.
“Full
time doctors can earn £54,000 as basic salary plus various benefits
including private healthcare. Sessional doctors work a minimum of
four sessions a week….The application forms for sessional doctors
state that ’10 DLA domiciliary visits per week would earn £40,211.60
per annum. Five LCWRA cases (limited
capacity for work related activity) per
session, for six session per week, would earn £62,883.60 per annum”.
“From the
recruitment evening, it was clear that the medical examination
consisted of a computerised form to be filled in by choosing
drop-down statements and justifying them”.
“Is
the current method of assessment fit for purpose? There is a queue
of people who think not. ‘Citizens Advice Scotland (CAS) is
extremely concerned that many clients are being found fit for
work…despite often having severe illness and/or disabilities. Our
evidence has highlighted the cases of many clients with serious
health conditions who have been found fit for work, including those
with Parkinson’s disease, multiple sclerosis, terminal cancer,
bipolar disorder, heart failure (and) strokes’. The report found
that clients often ‘felt hurried in their assessment and that the
healthcare professional was ignoring the answers they were providing
to the questions in the assessment. There was a general feeling
that the assessor made little eye contact with the claimant and
spent most of the assessment entering information into their
laptop’. This tallies with the recruitment evening, when it was
made clear that efficiency with entering details into the computer
system was a stipulation of employment”.
“The
Department for Work and Pensions says… ‘It’s unfair to suggest that
the system isn’t working….If a decision is overturned at appeal, it
does not necessarily mean that the original decision was
inaccurate…’. However, this doesn’t really deal with the problem
that the healthcare professionals doing the assessment are
not…forwarding sufficient evidence to enable reliable decisions”.
“At the meeting I asked how it
was possible to know the variation in symptoms that a patient may
have during a one-off assessment. I was told that this could be
‘difficult’ but this was….a ‘functional assessment’ ”.
“The Citizens Advice
Bureau…wants ‘better accuracy’ in reports. But how can this be
achieved when funding is devolved to Atos with no routine access to
detailed specialist or general practice based information and
opinion?”.
Returning to the DWP’s
Medical Service 2010, its “Learning Aims” are:
(i)
to
define CFS and FM (perhaps more accurately, to “re-define” them as
functional disorders)
(ii)
to
consider “possible causes and functional effects of these
conditions”
(iii)
to consider current management and treatment guidelines (ie. NICE
(iv)
to
“consider benefit issues in children and adults with CFS or FM”
and
(v)
to
“consider effects of these conditions on work/occupation and effect
of work on these conditions”
“It is essential that
the Learning Set achieves its learning aims and covers the essential
content….It is recommended that all attendees are reminded of the purpose of the
Learning Set, the responsibilities of all those present and the learning aims
reinforced”.
During training
discussions, participants must explore the following factors:
o
“Ways in which relevant
functional problems can present in a claim” (neither
ME/CFS nor FM is a functional disorder)
o
“The likely functional effects of
CFS and FM”
o
“Attitudes amongst the team
towards the condition”
o
“The claimant’s perceptions
of their disability and barriers to recovery” (such a
“barrier” is cited as belonging to a support group)
“The
challenge for the facilitator is to ensure that all participants are engaged
and prepared to commit to the consensus conclusions”
-- in other words, 100% commitment and absolute adherence to
the Wessely School model of “CFS/ME” is obligatory on the part of all DWP/Atos
Healthcare assessors dealing with patients with ME/CFS.
Would such
indoctrination be part of a training programme to assess those with other
classified neurological conditions such as multiple sclerosis or Parkinson’s
Disease?
These DWP training
programmes for assessors are extremely disturbing because, as Jason et al have
pointed out in a compelling article looking at kindling as the underlying
mechanism for the symptomatology seen in ME/CFS, these patients have evidence of
extremely serious pathology (An Aetiological Model for Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome. Neuroscience and Medicine
2011:2:14-27).
Jason et al posit that
kindling occurs when an organism is repeatedly exposed to an initially
sub-threshold stimulus resulting in hypersensitivity and spontaneous
seizure-like activity, and that in ME/CFS patients, chronically repeated
low-intensity stimulation due to an infectious illness might cause kindling of
the limbic-hypothalamic-pituitary axis and that, once this system is charged or
kindled, it can sustain a high level of arousal with little or no external
stimulus, which in turn could lead to hypocortisolism seen in ME/CFS patients,
and that seizure activity may spread to adjacent structures of the
limbic-hypothalamic-pituitary axis in the brain, which might be responsible for
the varied symptoms that occur in ME/CFS patients.
Jason et al cite
impressive supporting evidence, for example, Broderick, Fletcher and Klimas et
al
“Baraniuk et al
suggested that patients with ME/CFS had unusual proteins in the cerebrospinal
fluid, and the aggregation of these abnormal proteins…could cause small amounts
of bleeding in the brain (by) causing small punctures in the blood vessels and
then small amounts of blood leak into the brain. Other proteins suggest a
protease-antiprotease imbalance, increased free radical production,
vasoconstriction of the blood vessels, inflammation, and altered rates of cell
suicide. Baraniuk et al suggest that inflammation, haemorrhagic elements,
increased cell death, and free radical production could be by-products of damage
(by these) abnormally folded proteins impeding blood flow and ultimately
puncturing blood vessels in the brain”.
“Biswal, Kunwar and
Natelson found significant cerebral blood flow reductions in nearly every region
of the brain assessed….Neary et al tested whether patients with ME/CFS have
reduced oxygen delivery to the brain during and after exercise challenge. They
found that in addition to significant exercise intolerance, patients in
comparison to controls (have) reduced prefrontal oxygenation, suggesting altered
cerebral oxygenation and blood volume in the brain….Neurotropic viral infections
could be responsible for the appearance of lesions in the brain and the presence
of focal epileptiform seizure activity”.
Referring to the work
of Light et al, Jason notes that
“Light et al maintain
that exercise could send a continuous signal of muscle sensory fatigue to the
central nervous system causing dysregulation of sympathetic nervous system
reflexes….About 90% of the ME/CFS patients could be distinguished from control
subjects using just 4 of the genes measured…The researchers concluded that
ME/CFS patients might have enhanced sensory signal for fatigue that is increased
after exercise. These finding all indicate persistent changes in cell membrane
function”.
Referring to his
earlier (2009) work, Jason notes that it:
“suggests that
being over-extended and going beyond energy reserves can be an
impediment to improving functionality and fatigue levels” and it
concludes that “specific environmental cues”
may trigger ME/CFS. He is clear: “We need
studies based on systems biology that explain the illness, in
combination with more details about the environmental contributors
to the illness”.
None of these proven
pathologies can be ascribed to deconditioning or to abnormal illness beliefs
that are reversible with cognitive restructuring and aerobic exercise.
Just as Peter Dewis of
UNUMprovident sees a challenge in ensuring that people are directed towards
the Wessely School’s behavioural approach, a far greater challenge faces the
ME/CFS community in directing agencies of State such as the DWP, NICE, the MRC
and the NHS away from the Wessely School’s inflexible approach to a
chronic, inflammatory neuroimmune disorder.
For those involved at the
highest level in directing the DWP’s policy towards people with ME/CFS to have
been the ones involved with the PACE Trial could be seen to indicate an
unacceptable level of bias and commercial collusion against extremely sick and
vulnerable people for whose disorder there exists an abundant biomedical
evidence-base which continues to be systematically ignored by the PACE Trial
Principal Investigators and those they advise.
Footnote from IiME:
The DWP will be invited by Invest in ME to the 6th
Invest in ME International ME/CFS Conference on 20th May 2011 in
Westminster, London, in order to listen to real science and not the
outdated, unscientific and biased views which have so influenced the policies of
government and healthcare.
Dr. James Baraniuk will be speaking at the Invest
in ME conference .
Further information
Click here for more references to the PACE Trials on this site.
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