Evidence submitted by Professor Malcolm
Hooper (NICE 07)
INTRODUCTION
1. This memorandum relates to the work of
NICE in one specific area, namely its Guideline on the management
of adults and children with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
("CFS/ME") currently in preparation, a draft of which
was issued on 29 September 2006.
2. It is submitted by Malcolm Hooper, Professor
Emeritus of Medicinal Chemistry at the University of Sunderland,
in conjunction with Eileen Marshall and Margaret Williams—an
established team whose aim is to expose and prevent the injustice
perpetrated on patients with ME/CFS in the UK by those whose job
is to help, not abuse, such patients. Both Eileen Marshall and
Margaret Williams formerly held senior clinical posts in the NHS.
IMPORTANT BACKGROUND
INFORMATION
3. Terminology is confusing but important:
the term "ME/CFS" reflects the two interchangeable terms
(myalgic encephalomyelitis and chronic fatigue syndrome) that
are listed in the World Health Organisation's International Classification
of Diseases where, since 1969, ME has been classified as a neurological
(ie an "organic") disorder. However, certain UK psychiatrists
and the Government bodies they advise use the term "CFS/ME";
on their own admission, they do so merely to placate patients
by retaining the term "ME". Their recorded intention
is to eradicate "ME" and to re-classify "CFS"
as neurasthenia (a mental disorder). This has serious ramifications
for patients, since mental disorders receive lower rates of State
sickness benefits and are excluded from medical insurance cover.
4. The incidence of ME/CFS is rising alarmingly.
In order of insurance costs, one of the major medical insurance
companies (UNUM Provident) reported in 1993 that ME/CFS came second
in the list of the five most expensive chronic conditions, being
three places above AIDS. In August 2004 the same company issued
a Press Release reporting a 4,000% (four thousand) increase in
claims for symptom-based syndromes, including ME/CFS. No other
disease category surpassed these rates of increase. UNUM's "CFS
Management Plan" states: "UNUM stands to lose millions
if we do not move quickly to address this increasing problem".
The latest estimate (January 2007) of the economic impact of ME/CFS
in the US is between $22-$28.6 billion annually; in Japan it is
$10 billion annually.
5. Significant published evidence supports
the tenet that ME/CFS is an inflammatory autoimmune disorder that
progresses to a complex multi-system neuro-endocrine-immuno-microvascular
disorder with cardiac involvement. It devastates the lives not
only of patients themselves but also of their families. For a
short summary of the 8th International (ME)CFS Clinical and Research
Conference held in Ft Lauderdale, Florida in January 2007—at
which yet more evidence was presented that comprehensively destroys
the psychiatric paradigm so tenaciously adopted by NICE and the
UK Medical Research Council—see www.meactionuk.org.uk/Facts_from_Florida.htm
EXECUTIVE SUMMARY
6. In defiance of the substantial biomedical
evidence submitted to its Guideline Development Group (GDG), NICE
is recommending an inappropriate and potentially dangerous behavioural
modification regime as the only management strategy for those
with ME/CFS.
7. NICE's recommended management regime
is promoted by a group (mainly psychiatrists) who have undeclared
but undeniable competing financial interests. Their influence
has resulted in a biased and unrepresentative consideration of
the international peer-reviewed evidence upon which NICE is relying
to support its national Guideline that purports to be "evidence-based"
when it is nothing of the sort.
8. The evidence here submitted draws attention
to the intentionally selective advice that NICE receives from
its chosen advisors, who for almost two decades (ie before NICE
was set up in 1999) have dismissed and/or ignored the biomedical
evidence that is germane to the issues under consideration.
9. NICE maintains that its recommended psychotherapy
regime is also promoted in its Guidelines for other organic diseases.
This is untrue. This proposed Guideline for "CFS/ME"
seems to be unique: in none of a sample of 12 existing Guidelines
for organic disorders does NICE propose psychotherapy as the treatment
of choice—it is only in the case of ME/CFS that cognitive
behavioural therapy and compulsory graded exercise therapy (CBT/GET)
is proposed as a specific treatment. If, on medical advice, patients
refuse—or are simply too sick to participate in—this
regime, their State and medical insurance benefits are already
being withdrawn and some patients face destitution. Facing insuperable
odds, a significant number of ME/CFS patients have committed suicide.
10. In the case of ME/CFS, NICE has failed
to comply with the AGREE (Appraisal of Guidelines Research and
Evaluation) Instrument to which it is party.
FIRST TERM
OF REFERENCE
Why NICE's decisions are increasingly being challenged
11. The alleged "independence"
of NICE: NICE was set up—and is funded—by the Department
of Health, to which it remains accountable. A common perception
is that NICE is far from "independent" and that its
raison d'etre is to provide a shield for Government and Ministers
who seek to preserve an untarnished reputation when unpalatable
cost decisions have to be made, and who can then reassure the
electorate that they are relying on ostensibly "independent"
advice.
12. The evidence on which NICE has relied
for the production of its "CFS/ME" Guideline has been
provided by a small and unrepresentative group of self-styled
"experts" and their adherents who study a heterogeneous
patient population, resulting in flawed conclusions: Within their
own discipline, Wessely School psychiatrists are regarded as mavericks.
They are known colloquially as the "Wessely School"
after their prime mover Professor Simon Wessely of Kings College
Hospital and the Institute of Psychiatry (ref: Hansard [Lords]
19 December 1998:1013). Key members are Professors Michael Sharpe,
now at Edinburgh, and Peter White of St Bartholomew's, London
(who holds the "CFS/ME" reins at the Department for
Work and Pensions, whose own forthcoming DWP Guidance about "CFS/ME"
has been rejected as unfit for purpose by a coalition of ME charities).
The work of the Wessely School on "CFS/ME" has been
stringently criticised in the international literature for flawed
methodology; for use of a heterogeneous patient population (studies
using mixed populations are not useful unless researchers disaggregate
their findings); for selective manipulation of others' work, claiming
it supports their own findings when such is not the case; for
their focus on the single symptom of "fatigue" whilst
ignoring other significant signs and symptoms associated with
the cardiovascular, respiratory, neurological and immunological
systems; for generating conclusions before generating the data
to support such conclusions; for advising Government bodies that
the reported biomedical abnormalities "should not deflect
the clinician away from the biopsychosocial approach and should
not focus attention towards a search for an "organic"
cause", and for their recommendation that no advanced tests
should be carried out on "CFS/ME" patients when it is
those very tests that reveal the unequivocally organic nature
of the disorder. It is only when dealing with "CFS/ME"
that these psychiatrists are regarded by Government bodies and
the medical insurance industry as "experts". These psychiatrists
are on record as being actively involved in social engineering
via the deliberate creation of "psychosocial" illness.
They believe that the biomedical approach to healthcare (ie that
ill-health and disability is directly caused by disease and its
pathological processes) is (quote) "a blind alley" and
that the correct approach is the psychosocial one, in which "aberrant"
thoughts, feelings and behaviour can be "modified" by
their own brand of cognitive behavioural therapy with graded exercise
(CBT/GET), resulting in restoration of health and productivity.
Such a retrograde belief is fallacious, as the regime in question
has been shown to be ineffective, yet NICE ignores the evidence
submitted to it showing that even the proponents of its recommended
regime are themselves on record as acknowledging that:
(i) it is not remotely curative;
(ii) modest gains may be transient and even
illusory;
(iii) these interventions are not the answer
to ME/CFS;
(iv) patients have a tendency to relapse;
and
(v) evidence from randomised trials bears
no guarantee for treatment success (ref: www.meactionuk.org.uk/Concerns_re_NICE_Draft.pdf).
For a detailed review of Wessely School indoctrination
of State agencies, and the impact of this on social and welfare
policy, see www.meactionuk.org.uk/Proof_Positive.htm .
13. NICE has limited itself to—and
based its recommendations for the management of "CFS/ME"
on—a flawed 2005 Systematic Review from the Centre for Reviews
and Dissemination at York, whose lead author was persuaded to
change her mind between her 2001 article in the Journal of the
American Medical Association (JAMA) and her 2005 Review for NICE:
This may amount to scientific misconduct since the same author
has remarkably different approaches to the same data in the two
documents concerning the recommended psychiatric management regime
favoured by NICE (CBT/GET). In 2001, she found methodological
inadequacy; study withdrawals with high drop-out rates; unacceptability
to patients of the regime in question; the exclusion of severely
affected patients from all studies; the reported improvements
of the management regime may be illusory, with little lasting
benefit, and an acknowledgement that the data had been corrupted.
These findings were published in one of the world's most prestigious
medical journals (JAMA), yet in her York Review for NICE, the
same author disowns her own previous findings on exactly the same
data; she excludes the many reports of adverse events and signally
fails to address the safety and effectiveness of the recommended
interventions (a remit with which she was specifically charged).
A possible explanation for this volte-face is that the advisers
to the non-medical York Review Team who prepared the Review for
NICE were prominent members of the "Wessely School"
(ie advisors to Government Departments, including the Medical
Research Council, and the medical insurance industry). For an
analysis by Hooper and Reid of the 2005 York Systematic Review
upon which NICE is relying, see www.meactionuk.org.uk/FINAL_on_NICE_for_Gibson.html.
14. The advisors upon whom NICE relies have
been shown to have undeclared vested interests: These psychiatrists
and their adherents are heavily involved with the medical insurance
industry, including UNUM Provident, Swiss Life, Canada Life, Norwich
Union, Allied Dunbar, Sun Alliance, Skandia, Zurich Life and Permanent
Insurance, as well as the re-insurers Swiss Re, at which Peter
White is Chief Medical Officer. For the way in which these psychiatrists
deal with ME/CFS claims, see www.meactionuk.org.uk/Notes_on_the_Insurance_issue_in_ME.htm.
For an exposition of their commercial conflicts of interest in
relation to the Department of Work and Pensions, see www.meactionuk.org.uk/Obs_on_DLA_
Handbook_for_Gibson.html. Wessely is further involved with PRISMA,
a multi-national health-care company working for insurance companies.
In its company information, Wessely is listed as a Corporate Officer;
he is a member of the Supervisory Board and in order of seniority
he is higher than the Board of Management (for more information,
see www.meactionuk.org.uk/What_Is_ME_What_Is_CFS.htm). A recent
Report, known as the Gibson Report, by a group of Parliamentarians
(including Dr Richard Taylor, who is also a member of the Health
Select Committee) states: "There have been numerous cases
where advisors to the DWP have also had consultancy roles in medical
insurance companies. Given the vested interests medical insurance
companies have in ensuring CFS/ME remains classified as a psychosocial
illness, there is a blatant conflict of interest here. The Group
finds this to be an area for serious concern and recommends a
full investigation by the appropriate standards body" (For
a summary of the Report findings, see www.meactionuk.org.uk/Summary_of_Key_Points_in_Gibson_Inquiry_report.htm).
It is a matter of concern that NICE's chosen advisers on its "CFS/ME"
Guideline Development Group include Dr William Hamilton, who has
a published track record of believing "CFS/ME" to be
a behavioural disorder. Moreover, he has spent 15 years working
for the medical insurance industry and is currently Chief Medical
Officer for a major medical insurance company, the Exeter Friendly
Society. It was he who drew up the company policy that specifically
excludes those with "CFS/ME" from eligibility for sickness
benefit. Another member of NICE's GDG is psychologist Dr Hazel
O'Dowd who also subscribes to the "behavioural disorder"
model. However, she has recently published a paper that ought
to cause NICE to reconsider its recommendations, as it showed
that group CBT did not bring about the anticipated improvements.
Another NICE GDG member is Dr Fred Nye, who was forced to make
a public apology after his Department issued an advertisement
for therapists informing applicants that "CFS" patients
have "perpetuating illness behaviour"; that they experience
"barriers to understanding" and that therapists will
be required to "modify patients' predisposing personality
style". Had such attributions been ascribed to those with
multiple sclerosis, there would have been a national outcry. For
an analysis of legitimate concerns about the NICE draft Guideline
on "CFS/ME", see www.meactionuk.org.uk/Concerns_re_NICE_
Draft.pdf.
15. NICE's advisors have an indisputable
track record of denigrating patients with "CFS/ME":
Members of the "Wessely School" have a long track record
of denigrating patients with ME. See, for example, "Denigration
by Design?" at http://25megroup.org/denigration%20by%20design/denigration%
201.htm and also "The Mental Health Movement: Persecution
of Patients?" by Hooper et al at www.meactionuk.org.uk/Select_CTTEE_FINAL_VERSION.htm.
This includes in Appendices I and II a selection of quotations
from the published works on patients with "CFS/ME" of
Professors Wessely and Sharpe respectively, so Select Committee
members can judge this denigration for themselves. The "Wessely
School"—and now NICE itself—dismisses and/or
ignores the substantial body of international scientific evidence
which comprehensively proves them to be wrong in their assertions
that "CFS/ME" is primary mental disorder (see, for example,
the 174 page document "Illustrations of Clinical Observations
and International Research Findings from 1955 to 2005 that demonstrate
the organic aetiology of ME/CFS" by Hooper, Marshall and
Williams at www.meactionuk.org.uk/Organic_evidence_for_Gibson.htm.
See also the document "ME exists: True or False?" at
www.meactionuk.org.uk/ME_Exists_-_True_or_False.htm). It is beyond
reason that so many documented physical abnormalities in people
with ME/CFS should simply be disregarded and/or denied and ascribed
to a "behavioural" disorder by NICE, including the following:
abnormalities of the central nervous system, of the autonomic
and peripheral nervous systems, of the cardiovascular, respiratory
and immune systems; evidence of muscle pathology; neuroendocrine
abnormalities; defects in gene expression profiling; abnormalities
in HLA antigen expression; evidence of persistent virus activity,
with abnormalities in the 2-5 synthetase / RNase-L antiviral pathway;
disturbances in oxidative stress levels; gastro-intestinal, reproductive
and visual dysfunction, all of which are dismissed—and even
actively suppressed in the UK—by Wessely School psychiatrists
in their advice to Government bodies, and to NICE.
16. The evidence about "CFS/ME"
upon which NICE relies has been proven to be biased in favour
of current Government policy to create nationwide centres for
psychotherapy: It is well-known that, on the advice of Lord Layard,
in order to remove people from Incapacity Benefit, Government
favours cognitive behavioural therapy for all chronic ills. This
is borne out by the negative stance taken by the MRC when considering
research applications into the organic aetiology of ME/CFS—documentary
evidence exists showing that the MRC internally classifies "CFS/ME"
as a mental (behavioural) disorder; by NHS Plus in its published
Policy Document of October 2006 ("Occupational Aspects of
the Management of CFS: a National Guideline" [DH publication
2735539], whose external advisors were psychiatrists Professors
Michael Sharpe and Peter White), and by NICE's own entrenched
position about its preferred management regime, namely behavioural
therapy, which has already been promoted and disseminated throughout
the NHS as "effective treatment for CFS" in its "Effective
Health Care" Bulletin of 23 May 2002 by the York Centre for
Reviews and Dissemination. Given the existing extensive implementation
of this policy and the relentless dissemination of its alleged
efficacy by its proponents (for example, the assiduous advertising
of a lecture at the Institute of Psychiatry on 28 February 2007
by Professor Trudie Chalder—a staunch advocate of the behavioural
model of ME/CFS who works with Simon Wessely—promoting NICE's
advocacy of behavioural and exercise "therapy" for ME/CFS),
unless legally compelled to change direction in line with the
international evidence that has been so effectively downplayed
by its advisors, NICE is unlikely to do so. This would be to the
serious detriment of between 120,000 and 240,000 very sick people
in the UK (figures given in the Chief Medical Officer's Report
of 2002), which is a prevalence five times that of HIV/AIDS. For
comparison, there are about 83,000 people in the UK who suffer
from multiple sclerosis. According to the US Centres for Disease
Control, four million Americans have ME/CFS (see http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0701d&L=co-cure&T=0&P=5201),
which is more than those who suffer from multiple sclerosis, lupus,
lung cancer and ovarian cancer combined. In the US, lung cancer
alone has a prevalence of 350,000 (ie about half that of ME/CFS).
17. NICE fails to adhere to its own terms
of reference: NICE is a party to the Appraisal of Guidelines Research
and Evaluation Instrument (the AGREE Instrument) so is obliged
to conform to certain standards in the production of its Guidelines,
which in the case of this Draft "CFS/ME" Guideline it
has signally failed to do. The NICE Guidelines are intended to
be "systematically developed statements to assist practitioner
and patient decisions about appropriate healthcare for specific
clinical circumstances". Their purpose is "to make explicit
recommendations with a definite intent to influence what clinicians
do". Because the intent is to influence what clinicians do
(which immediately impacts on patients), there are rigorous criteria
(currently 23) which policy makers and Guideline developers must
observe in the production of a Guideline. The most important criteria
in relation to the Draft Guideline on "CFS/ME" are:
— There should be an explicit statement
that all group members have declared whether they have any conflicts
of interest: there is no evidence in the Draft Guideline that
GDG member Dr William Hamilton has made any such declaration.
— The patients to whom the Guideline
is meant to apply should be specifically described: the Draft
Guideline fails this criterion as there is no such disorder as
"CFS/ME": the Wessely School believe that "CFS"
is synonymous with neurasthenia, which is a classified mental
disorder at ICD-10 F48, but ME/CFS is a classified neurological
disorder at ICD-10 G93.3 and fibromyalgia is a classified soft
tissue disorder at ICD-10 M79; to lump these different disorders
together as one single disorder (as the MRC does in its on-going
"CFS" trials led by Wessely School psychiatrists) is
in defiance of established WHO taxonomic principles, particularly
as research from Spain presented at the Ft Lauderdale International
Conference emphasised that ME/CFS and fibromyalgia are two genetically
distinguishable illnesses.
— The Guideline Development Group should
include individuals from all the relevant professional groups:
the Draft Guideline fails this criterion: whilst mental health
professionals are well represented on the Guideline Development
Group, and whilst there is a neurologist and an immunologist listed,
their experience of patients with ME/CFS is not known. Conspicuous
by their absence are a virologist, a clinical allergist, a microbiologist,
an endocrinologist, a pharmacologist, a rheumatologist, a molecular
biologist, a biochemist, a biostatistician, and experts in vascular
medicine, nuclear medicine and genomics, all of whose input is
essential to understanding the nature of ME/CFS.
— The patients' views and preference
should be sought and the patient/carer members must have equal
status on the GDG: the Draft Guideline pays lip-service to the
need to listen to patients' and carers' views but then entirely
ignores them when they have been submitted.
— The health benefits, side effects
and risks should be considered when formulating the recommendations:
the Draft Guideline fails in this respect. All relevant patient
surveys consistently report that a high percentage of patients
are made worse by exercise therapy. Failure to report such adverse
events may constitute research misconduct.
— The potential cost implications of
applying the recommendations should be considered: the Draft Guideline
fails this criterion. Assessment of cost-effectiveness must be
carried out in respect of maximising health gain so that resources
are not employed in interventions that are not cost-effective,
but it is already known that the only recommendations in the Draft
Guideline—CBT/GET—have very limited (and certainly
not lasting) benefit and are not in any way curative, as recognised
by even its keenest advocates. Moreover, there is substantial
evidence that patients with ME/CFS are actually made worse by
these recommended interventions. Further, the cost implications
of recruiting, training and supervising an army of behavioural
therapists needed to deliver NICE's recommendations will be considerable.
Given that its recommended intervention is already known to have
no lasting benefit, how can NICE's recommendations be considered
cost-effective?
— There should be an explicit link
between the recommendations and the supporting evidence: the Draft
Guideline fails this criterion: the alleged "evidence-base"
is exceptionally weak yet NICE gives it more weighting than the
patients' evidence, when there should be equal weighting.
— The Guideline should be editorially
independent from the funding body: the funding body for NICE is
the Department of Health; does NICE pay its editorial and other
advisers with funding received from the Department of Health?
If so, funding is not independent. If not, from where does it
get any additional funding?
Whether public confidence in NICE is waning, and
if so why
18. Public confidence in NICE is indeed
waning: Given the extent and high calibre of the biomedical evidence
known to have been submitted to—but ignored by—NICE,
it is obvious that NICE's remit is to produce policy-based evidence
instead of evidence-based policy. Its cavalier disregard of so
much credible biomedical evidence justifies the public lack of
confidence in NICE.
NICE's evaluation process and whether any particular
groups are disadvantaged by the process
19. Patients with ME/CFS are at risk of
being actively damaged by NICE's biased evaluation process: for
NICE's evaluation process to exclude the evidence that its recommended
regime is potentially harmful puts those with ME/CFS at immediate
and unacceptable risk.
20. Patients with ME/CFS are disadvantaged
by NICE's consultation process: for its own convenience, NICE
insists that all comments on its Draft Guideline be submitted
online, but many patients with ME/CFS do not have a computer or
may be too sick to use one. This means that a significant proportion
of the patients' voice is excluded, which is in breach of the
AGREE Instrument to which NICE is party.
The speed of publishing guidance
21. The time taken by NICE to produce any
of its Guidelines is unacceptably slow: in the case of ME/CFS,
it is now over five years since the publication of the Chief Medical
Officer's Report of January 2002 and still no Guideline has been
produced.
Remaining Health Select Committee Terms of Reference
22. We have no comment to make concerning
the Health Select Committee's remaining terms of reference.
Professor Malcolm Hooper
March 2007
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