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History and Classification of
Myalgic Encephalomyelitis Myalgic Encephalomyelitis (ME) has
been documented in the medical literature from 1934. (1) The
Wallis description of ME (not Chronic Fatigue Syndrome, known as CFS
- see below) was in 1957. (2) Sir Donald Acheson's (a former
UK Chief Medical Officer) major review of ME was in 1959. (3)
In 1962, the distinguished neurologist Lord Brain included it in the
standard textbook of neurology. (4)
ME has been formally
classified by the World Health Organisation as a neurological
disorder in the International Classification of Diseases (ICD) since
1969 (ICD-8: Vol I: code 323, page 158; Vol II (Code Index) page
173).
On 7th April 1978 the Royal Society of Medicine held a
symposium on ME at which ME was accepted as a distinct entity. The
symposium proceedings were published in The Postgraduate Medical
Journal in November that same year. (5) The Ramsay case
description was published in 1981. (6) Since 1989, the
Medical Information Service of the British Library has produced
quarterly updates on the disorder: these updates (known as CATS, or
Current Awareness Topics) compile published international research
and clinical evidence about the condition and contain abstracts of
published articles. The Centres for Disease Control (the US federal
agency charged with the containment of diseases and known
internationally as the CDC) designates it for funding status as "A
serious legitimate diagnosis CDC PRIORITY 1 disease of public health
importance".
ME remains classified in the
current ICD as a neurological disorder (ICD 10. G.93.3) and the
World Health Organisation has confirmed that there are no plans to
reclassify it as a psychiatric disorder in the next revision of the ICD (due in 2003).
Chronic Fatigue Syndrome (CFS) is
listed in ICD-10 as a term by which ME is also known, as is the term
Postviral Fatigue Syndrome (PVFS). The term "CFIDS", or Chronic
Fatigue and Immune Dysfunction Syndrome, is used by some groups in
the US.
Description of Myalgic Encephalomyelitis
ME / ICD-CFS is a serious,
disabling and chronic organic (ie. physical not mental) disorder:
80% of patients do not get better. (7) According to US
statistics provided by the Centres for Disease Control (CDC), only
4% of patients had full remission (not recovery) at 24 months.
(8)
International expert Daniel
Peterson is on record as stating about ME / ICD-CFS:
"In my experience, (it) is one of
the most disabling diseases that I care for, far exceeding HIV
disease except for the terminal stages". (9)
American researchers found that the
quality of life is particularly and uniquely disrupted in ME / ICD-CFS
and that all participants related profound and multiple losses,
including loss of jobs, relationships, financial security, future
plans, daily routines, hobbies, stamina and spontaneity. Activity
was reduced to basic survival needs for some subjects. The
researchers found that the extent of the losses experienced by
sufferers was devastating, both in number and intensity. (10)
Australian researchers found that
patients with this disorder had more dysfunction than those with
multiple sclerosis, and that in ME / ICD-CFS the degree of
impairment is more extreme than in end-stage renal disease and heart
disease, and that only in terminally ill cancer and stroke patients
was the sickness impact profile (SIP) greater than in ME /ICD-CFS.
(11)
The incidence of ME / ICD-CFS is
known to be rising: in April 1994, the insurance company UNUM (one
of the largest disability insurers) reported that in the five years
from 1989 - 1993, mens' disability claims for CFS increased 360%,
whilst womens' claims for CFS increased 557%.
No other disease
category surpassed these rates of increase. In order of insurance
costs, ME/ICD-CFS came second in the list of the five most expensive
chronic conditions, being three places above AIDS.
At the Fifth
American Association of Chronic Fatigue Syndrome International
Research and Clinical Conference held in January 2001 in Seattle,
the Associate Director of the University of Washington's CFS
Research Centre (Dr N Afari) confirmed that the incidence is indeed
rising.
Of potential significance is the
fact that American researchers have demonstrated that in ME / ICD-CFS,
a particular pathway in the body which is affected by viruses can
also be affected by chemicals. (12)
The strike rate is higher than
multiple sclerosis. Comparisons have been made between the
prevalence of ME /ICD-CFS and MS in the UK, in the USA (13)
and in Australia (14) and have been estimated to be three
times, twice and equivalent respectively. Prevalence estimates in
Britain vary by a factor of 8, which is a reflection of the problem
of definition.
In the UK it is generally believed
that at least 300,000 suffer from the disorder; some psychiatrists,
however (see below), having themselves broadened the case definition
to include psychiatric disorders, claim that there are over one
million "CFS" sufferers in the UK, of which they assert 75% have a
psychiatric disorder. (15)
Estimated direct NHS costs are said
to be from £180 million to just over £1 billion per annum, depending
on the choice of prevalence estimates, with total costs ranging from
£879 million to nearly £16 billion. (16)
ME/ ICD-CFS is a multi-system
disorder, one form of which can be associated with
enteroviruses
related to the poliomyelitis virus. (17) Virally-induced ME
used to be known as "atypical poliomyelitis". There are acknowledged
similarities and overlaps between ME and the post-polio syndrome
(PPS), particularly concerning the nature and source of the
pathophysiology, including virological evidence that enteroviruses
persist in the human central nervous system. Specifically, the
mechanism of the incapacitating exhaustion is identical in the two
conditions (i.e. in ME and PPS). (18) In ME there are chronic
sequelae and the effects may be neurological, hormonal, autoimmune
and myalgic, which may include the myocardium. (19)
Symptoms documented in
Myalgic Encephalomyelitis
In ME, symptoms are seemingly
without end. There is a remarkable variability of signs and symptoms
from day to day and even from hour to hour: Hyde and Jain (20)
(quoting Pellew) describe this variability:
"A patient examined in the morning
might have nystagmus, which would
disappear at midday, recur later, disappear later and recur the next
day".
This waxing and waning in the same
patient in the same day is typical of almost all findings in ME /
ICD-CFS and may lead to medical scepticism.
The most apparent features are
extreme post-exertional muscle fatiguability, which is quite
distinct from chronic "fatigue" or tiredness, together with
recurrent nausea and profound, incapacitating malaise. It is
striking how consistent are the symptoms that characterize this
condition. (21) The exhaustion experienced by patients is
extreme:
"the disabling weakness and
exhaustion a patient with ME / ICD-CFS
experiences is so profound that "fatigue" is probably an insult".
(22)
ME commonly starts with abdominal
pain and diarrhoea, together with a persistent headache and / or
vertigo, with a stiff neck and back, together with generalised
myalgia, described as intense and burning. Muscles are tender to
palpation and muscle spasm is not uncommon. There may be severe,
intractable pain in particular groups of muscles, most notably in
the neck and in the shoulder and pelvic girdles: the more severely
affected are unable to stand unsupported for more than a few
minutes. There is sometimes segmental pain in the chest wall.
In the more severely affected,
dizziness is a particularly striking and chronic feature, as is
persisting dysequilibrium and ataxia, with patients frequently
bumping into things and becoming bruised. There is impaired
neuromuscular coordination, particularly with fine finger movements.
In the severely affected, there may be difficulty with swallowing;
choking fits are not infrequent. There may be difficulty with voice
production, particularly if speaking is sustained.
There may be seizures, although
these are found only in the most severe cases.
In the most severe cases,
photophobia and hyperacusis are common, as is tinnitus; often there
is parasthesia.
Hypersomnia is prevalent,
especially in the early stages of the disorder; this may be replaced
by reversed sleeping patterns, with vivid and disturbing dreams;
unrefreshing sleep is common.
Abdominal pains often recur;
especially in the severely affected, there are usually chronic
problems with diarrhoea and frequency of micturition, including
nocturia. Bladder and bowel control may be insecure.
Cardiac
arrythmias are very common,
with pronounced tachycardia and an uncomfortably pounding heart;
there may be paroxysmal attacks of angina-like chest pain. Cardiac
pain is a recognised feature: patients may be convinced they are
suffering a heart attack.
Myocarditis was a common symptom in an
analysis of 1,000 ME/ ICD-CFS patients seen in Glasgow, where
clinicians were struck by the often-occurring association of
patients with ME/ICD-CFS with acute chest pain resembling coronary
thrombosis. (23)
A significant number of cases of Syndrome X
strongly resemble ME / ICD-CFS clinically, and nuclear magnetic
resonance spectroscopy studies of skeletal muscle in patients with
Syndrome X show abnormalities that are identical to those found in
patients with ME / ICD-CFS. (24) Syndrome X is characterised
by typical anginal pain with a normal coronary angiogram: (25)
in both Syndrome X and ME / ICD-CFS, blood supply to the heart
muscle seems to be going haywire, but in Syndrome X there is
desensitivity of the cell endothelium, whilst in ME / ICD-CFS there
is heightened sensitivity of the cell endothelium. Syndrome X has
been defined as a cluster of symptoms secondary to resistance of
insulin-mediated glucose uptake; (26) it has been seen in
association with increased risk for coronary heart disease due to
enhanced growth and proliferation of arterial smooth muscle cells
and highly elevated levels of cholesterol.
In the more severely affected,
palindromic arthropathies regularly recur; spontaneous periarticular
bleeds are frequent, especially in the fingers, which become swollen
and painful, making the patient appear even more clumsy.
Pancreatitis is not uncommon and
may cause acute, severe pain: pancreatic exocrine insufficiency
leads to malabsorption, which is a well-recognised feature found in
the more severely affected; some patients have almost non-existent
pancreatic exocrine function. Some patients have been shown to have
achlorhydria.
Food intolerance is a prominent
feature across all degrees of severity: multiple sensitivities to
normal foods and household chemicals (including perfumes, chemical
treatments of furniture and carpets such as flame-retardants and
glues in chipboard), petrol and agricultural chemicals are frequent.
Intolerance to alcohol and to medicinal drugs, particularly to
antidepressants, is virtually pathognomonic. (27) Patients
have to be cautious about all drugs but especially those acting on
the central nervous system (ie. anaesthetics), as there is an
increased occurrence of adverse reaction. (28)
ME affects not only the central
nervous system but the autonomic and peripheral nervous systems as
well. Sympathetic nervous system dysfunction is integral to ME /
ICD-CFS pathology (29) and includes blurred and double
vision, with difficulty in focusing and visual accomodation; eyes
may be dry and eyelids are often swollen and painful.
Typical
autonomic symptoms include alternate sweating and shivering, with
marked thermodysregulation. Patients experience orthostatic
hypotension and symptoms of hypovolaemia, with blood pooling in the
legs and insufficient blood flow to the brain: patients may feel
faint, shaky and nauseous; they can be tearful and observably pale
and they may experience severe distress.
Heightened sensory input awareness
might be called an "acid test" for ME / ICD-CFS: one world expert
claims that it is possible to make a diagnosis by taking a patient
into a shopping mall (he calls it the Mall Test) because with all
the lights, noise, echoes, smells, movement and confusion, a
sufferer would be ready to explode. (30)
In the more severely affected,
commonly there is difficulty with breathing, with sudden attacks of
breathlessness and dyspnoea on minimal effort; the administration of
oxygen may be necessary.
Rashes may occur; mouth ulcers may
be recurrent and may be painful and severe to the extent that
speaking and eating may be affected.
Hands and feet are frequently cold,
blanched and / or purple, with painful vascular spasms seen in the
fingers.
Vascular headaches are common and
recurring. (31)
In females, ovarian-uterine
dysfunction is not uncommon; in males, prostatitis and impotence may
occur.
Many patients can walk only very
short distances and require a wheelchair. There is difficulty with
simple tasks such as climbing stairs and dressing.
Problems with short-term memory are
common: (32) cognitive impairment is significant and includes
difficulty with memory sequencing, processing speed, word searching;
dyslogia, spatial organisation, calculation (dyscalculia), and
particularly with decision-making. In relation to the degree of
cognitive impairment, American researchers found that
"the performance of the CFIDS
patients was sevenfold worse than either the control or the
depressed group. These results indicated that the memory deficit in
CFIDS was more severe than assumed by the CDC criteria. A pattern
emerged of brain behaviour relationships supporting neurological
compromise in CFIDS". (33)
Uncharacteristic emotional lability is very common; there may be an
increased irritability. Patients are often understandably anxious
and afraid.
There may be significant and
permanent damage to skeletal or cardiac muscle as well as to other
end-organs including the liver, pancreas, endocrine glands and
lymphoid tissues, (34) with evidence of dysfunction in the
brain stem. Injury to the brain stem results in disturbance of the
production of cortisol (required for stress control) via damage to
the hypothalamus and to the pituitary and adrenal glands, and
patients react extremely adversely to stress.
Cycles of severe relapse are
characteristic and common, together with the evolution of further
symptoms over time. ME is rarely listed as the cause of death,
although after decades of illness, death from end-organ damage
(mainly cardiac or pancreatic failure) is known to occur.
Suicide rates are high (35)
and are said to be the most common cause of death in ME and to be
related to the current climate of disbelief and rejection of welfare
support. (36)
Evidence of abnormalities in
ME
Despite beliefs and assertions to
the contrary, in ME there is evidence of inflammation of the central
nervous system (CNS); that is what helps to differentiate ME from
other forms of CFS.
There are many references in the medical
literature to inflammation of the CNS in ME and in ICD-CFS
(37),(38),(39),(40),(41),(42) but such CNS inflammation is not
found in all variants of CFS. It is incorrect to deny the existence
of CNS inflammation in ME / ICD-CFS. In some cases of ME, as in
multiple sclerosis, there is evidence of oligoclonal bands in the
cerebrospinal fluid. (43),(44)
It is accepted by the most
experienced ME clinicians that some degree of encephalitis has
occurred both in patients with ME and in those with post-polio
syndrome: the areas chiefly affected include the upper spinal motor
and sensory nerve roots and the spinal nerve networks traversing the
adjacent brain stem (which is always damaged). (45)
In nearly
every patient there are signs of disease of the central nervous
system. (46) Recent research continues to support
neurological involvement. (47),(48),(49),(50),(51),(52),(53)
There is a substantial literature
on the neuroendocrine dysfunction which has been demonstrated in ME
/ ICD-CFS, particularly the known dysfunction of the
hypothalamic-pituitary-adrenal axis (HPA axis), leading to a
disordered stress response.
There is mounting international
evidence that ME / ICD-CFS is an autoimmune disorder, with
similarities to systemic lupus erythematosus. (54),(55)
Evidence of antilamin antibodies has been found in the blood of ME /
ICD-CFS patients: antibodies against this protein are proof of
autoimmunity and of damage to brain cells. The occurrence of
autoantibodies to an intra-cellular protein like lamin B1 provides
laboratory evidence for an autoimmune component in ME / ICD-CFS.
(56),(57)
In the UK, patients with autoimmune
features and neurological signs and symptoms are usually the most
sick and as such they are excluded from studies of "CFS" or chronic
fatigue undertaken by psychiatrists, so the results of UK studies
from which such patients are excluded are not representative of the
true situation.
A particularly important piece of
research in these patients has demonstrated sensitivity of the
vascular endothelium to acetylcholine (a major neurotransmitter and
vascular dilator) and this finding may have implications for many
other cholinergic pathways (which are extensive throughout the
body). (58)
In ME / ICD-CFS there is evidence
of disruption in ion channels in the cell membranes; changes in ion
channel function from time to time offer a rational basis to explain
the fluctuating symptoms, and such ion channel changes are known to
be induced by physical activities, stress and fasting. If sodium
channels are blocked in the open mode, this causes entry of sodium
into neural tissues and muscles. This ingress of sodium is followed
by water, which in turn leads to swelling of the neural tissues, a
phenonmenon observed both electron microscopically and by laser
scanning microscopy. Acquired ion channel abnormalities in the
myocardium could explain the pathogenesis of Syndrome X and may form
the basis of cardiac dysfunction in both Syndrome X and in ME /
ICD-CFS. (59)
Australian researchers have found
that total body potassium (TBK) is significantly lower in patients
with ME / ICD-CFS; they suggest that abnormal potassium handling by
muscles in the context of low overall body potassium may contribute
to muscle fatigue in this disorder. (60) Burnett reports that
there is a reduced flux of potassium across the cell membrane (which
fits in with a channelopathy) and that patients will feel more ill
the lower the potassium levels. TBK results for ME / ICD-CFS
patients have also been shown by others to be significantly lower
than those for controls; this fits with other metabolic
abnormalities in these patients, such as impaired water metabolism.
(61)
There is convincing evidence that
patients with ME / ICD-CFS reach exhaustion more rapidly than normal
subjects: the use of 31 P-nuclear magnetic resonance (31 P-NMR) has
now provided positive evidence of defective oxidative capacity in
such patients. (62)
These findings show that there is a
continued loss of post-exertional muscle power (giving an additional
loss of power), with delayed recovery for at least 24 hours, whereas
sedentary controls recovered full muscle power after 200 minutes.
A genetic component to ME / ICD-CFS
is strongly suggested by HLA phenotyping analysis in the laboratory
of Paul Terasaki at UCLA School of Medicine. Terasaki is one of the
world's leading experts in HLA typing and he found 46% of ME /
ICD-CFS patients were HLA-DR4 positive. (63) However, in a
small study of only 58 patients, Wessely (a UK psychiatrist - see
below) found no association between HLA genotype and CFS and claims
there is no significant difference in HLA frequencies between
patients and controls. (64)
In the February 2000 issue of The
American Journal of Medicine, Anthony Komaroff (Assistant Professor
of Medicine at Harvard and a world expert on this disorder)
summarised key points in an Editorial:
"Many controlled studies have compared patients with age-matched and
gender- matched healthy control subjects. Objective biological
abnormalities have been found significantly more often in patients
with the syndrome than in the comparison groups. The evidence
indicates pathology of the central nervous system and immune system.
What is the evidence of central nervous system pathology? Magnetic
resonance imaging has revealed areas of high signal in the white
matter. Single photon emission computed tomography (SPECT) signal
abnormalities also are found more often in patients, abnormalities
like those seen in patients with encephalopathy due to the acquired
immunodeficiency syndrome (AIDS) and unlike the findings in patients
with depression. Autonomic nervous system testing has revealed
abnormalities of the sympathetic and parasympathetic systems that
are not explained by depression or physical deconditioning. Studies
of hypothalamic and pituitary function have revealed neuroendocrine
abnormalities not seen in healthy control subjects and opposite to
those found in depression. There is considerable evidence from
different investigators, using different technologies and studying
different groups of patients, of a state of chronic immune
activation. In summary, there is now considerable evidence of an
underlying biological process in most patients (which) is
inconsistent with the hypothesis that (the syndrome) involves
symptoms that are only imagined or amplified because of underlying
psychiatric distress. It is time to put that hypothesis to rest".
(65)
Precipitating Factors
Precipitating factors are
acknowledged to include stress, (66),(67),(68) exposure to
toxic chemicals, (69),(70) and physical trauma - particularly
a motor vehicle accident. (71),(72)
There is convincing evidence that
when combined with physical trauma, chemical or biological insult,
stress potentiates the condition and that the disorder may be due in
part to multiple chemical and / or biological exposures which have
been shown to increase the permeability of the blood brain barrier
(BBB), leading to a significant brain injury. (73),(74),(75)
Evidence of BBB breakdown in ME / ICD-CFS was presented at the
international conference held in London in April 1999: scientists in
Israel have shown that severe stress (physical or mental) can
produce breakdown of the BBB; if that barrier is broken, small
amounts of substances which are normally outside the brain could
produce brain injury. It is postulated that in the case of ME /
ICD-CFS, a person already under physical or mental stress is exposed
to an agent (viral or chemical) which crosses the BBB, enters the
brain, and produces long-term dysfunction. (76)
John Dwyer, Professor of Medicine
at the University of New South Wales, Australia, states that his
team has seen ME / ICD-CFS stimulated by vaccination and that they
have seen it both with vaccinations such as those for influenza and
also with the use of material which is not live, such as that in a
tetanus toxoid injection. (77),(78)
The disorder is known sometimes to
occur or worsen after anaesthetics, (79),(80),(81) and to be
related to some infections (both viral and bacterial). There is a
considerable literature on the viral aspects of the disorder, the
most implicated viruses being Coxsackie B (82),(83) and Human
Herpes Virus 6 (HHV6). (84),(85) HHV-6 has been found in
patients suffering from ME / ICD-CFS and also in MS; it has also
been linked to other autoimmune conditions such as systemic lupus
erythematosus (SLE or lupus).
Physical signs found in ME
In cases of severe ME there are
definite physical signs indicative of physical illness and not of
abnormal illness behaviour. Some of these signs are often present in
less severely affected cases but in the UK are dismissed or
trivialised in order to comply with the currently-favoured
psychiatric definition of CFS. Not all patients have all signs, but
throughout the ME literature, the following are common in the
sickest patients.
Observable signs include a
typically swinging low-grade temperature, nystagmus; sluggish visual
accommodation; abnormality of vestibular function with a positive
Romberg test; abnormal tandem or augmented tandem stance; abnormal
gait; hand tremor; incoordination; cogwheel movement of the leg on
testing; muscular twitching or fasciculation; hyper-reflexia without
clonus; facial vasculoid rash; vascular demarcation which can cross
dermatomes with evidence of Raynaud's syndrome and / or vasculitis;
(86) mouth ulcers; (87),(88) hair loss;
(89),(90),(91),(92),(93) a labile blood pressure (sometimes as
low as 84/48 in an adult at rest); flattened or even inverted
T-waves on 24 hour Holter monitoring (94) (a standard 12 lead
ECG is usually normal); orthostatic tachycardia; shortness of breath
(patients show significant reduction in all lung function parameters
tested); (95) abnormal glucose tolerance curves; liver
involvement (96),(97),(98),(99),(100) (an enlarged liver or
spleen may not be looked for in ME, so missed) and destruction of
fingerprints: (atrophy of fingerprints is due to perilymphocytic
vasculitis and vacuolisation of fibroblasts (101)).
In his Testimony before the FDA
Scientific Advisory Committee on 18th February 1993, Dr Paul Cheney
(Professor of Medicine at Capital University; Medical Director of
the Cheney Clinic, North Carolina and one of the world's leading
exponents on ME /ICD-CFS) testified as follows:
" I have evaluated over 2,500
cases. At best, it is a prolonged post-viral syndrome with slow
recovery. At worst, it is a nightmare of increasing disability with
both physical and neurocognitive components. The worst cases have
both an MS-like and an AIDS-like clinical appearance. We have lost
five cases in the last six months. The most difficult thing to treat
is the severe pain. Half have abnormal MRI scans. 80% have abnormal
SPECT scans. 95% have abnormal cognitive-evoked EEG brain maps. Most
have abnormal neurological examination. 40% have impaired cutaneous
skin test responses to multiple antigens. Most have
evidence of T-cell activation. 80% have evidence of an up-regulated
2-5A antiviral pathway. 80% of cases are unable to work or attend
school. We admit regularly to hospital with an inability to care for
self".
People with ME are permanently
excluded from being blood donors. (102)
Twenty-five per cent of sufferers
are severely affected and are either house or bed bound; they are
invisible and for the most part, they are ignored and abandoned to
their own fate.
A major Report by the charity
Action for ME (103) found that 77 % of sufferers experienced
severe pain; over 80% had felt suicidal as a result of the illness;
70% are either never able, or are sometimes too unwell to attend a
doctor's clinic; 65% (nearly two out of three) have received no
advice from their GP on managing this illness; 80% of those who are
currently bedridden by ME report that a request for a home visit by
a doctor has been refused; many people do not receive state benefits
to which they are clearly entitled.
Despite all this verifiable and
authenticated international research, much of the current perception
of ME, both medical and lay, is beset by confusion and
misinformation.
There are still doctors who
dismiss the condition as non-existent and too many sick children are
still being forcibly removed from their parents and placed in
institutional care where they are forced to undergo inappropriate
exercise regimes under the care of psychiatrists.
Very recently, there have been two
tragic ME cases involving children: in one case social workers,
accompanied by uniformed police officers, appeared unannounced on
the doorstep to take away a child under a Child Protection Order;
the other child had been made a Ward of Court.
In July 2001, the appalling
treatment of children with ME / ICD-CFS was the subject of a major
feature written by the Countess of Mar in The Daily Telegraph.
(104) Cases such as these have been only too common since the
late 1980s: support for families in such situations is available
from the mother of a child who was compelled to go to the High Court
to stop the local Council and NHS Healthcare Trust from using child
protection procedures to force her sick son into psychiatric
treatment without his parents' consent and in disregard of competent
but differing medical opinion (telephone: Val Broke Smith: 01564 -
778649).
Refusal by some doctors to accept
what is known about ME /ICD-CFS may raise the question of whether or
not such doctors are in breach of their contract of employment if
that contract requires them to keep abreast of advancing medical
knowledge. Guidance issued by the General Medical Council (GMC)
requires that doctors "must observe and keep up to date with the
laws and statutory codes of practice which affect your work."
(105) The law cannot be used to enforce alternative treatment on
a patient already receiving competent medical treatment just because
doctors disagree.
The fact that so many doctors do
not keep reasonably up-to-date about ME / ICD-CFS has enormous
implications for patients. (106)
Changing Definitions: History
of Chronic Fatigue Syndrome (CFS)
In the US in the late 1970s and
1980s there seemed to be a remarkable rise in incidence of a
condition indistinguishable from ME, with manifestations of serious
neuro-immune disease and profound incapacity, to the extent that the
powerful insurance industry became alarmed.
The insurance industry
was concerned that, because there is no National Health Service in
the US:
"the field could change from an
epidemiological investigation into a health insurance nightmare".
(107)
The result was a determination to
suppress the true symptomatology and to construct a new case
"definition" for which insurers could not reasonably be liable: the
condition was henceforth to be called 'chronic fatigue syndrome' or
CFS and emphasis was to be on chronic "fatigue" as the primary
symptom.
The case definition required every sign of organic illness
to be excluded before the diagnosis of "CFS" could be made. As a
result, the view that patients were clearly afflicted by serious neuro-immune illness was to be strenuously down-played for many
years. (108)
"CFS" did not come into existence
until 1988. As a basis for sound scientific research,
it has been a
disaster. "CFS" is not a single diagnostic entity and "fatigue" is
not a disorder, it is a symptom. The term "CFS" is now applied to a
heterogeneous group as a non-specific label which embraces many
different medical and psychiatric conditions in which tiredness and
fatigue are prominent.
The first definition of CFS (1988
Holmes et al) concentrated on "fatigue" persisting for at least six
months; it expressly excluded the cardinal features of ME which had
been documented for decades despite the fact that ten years earlier,
the UK Royal Society of Medicine had accepted ME as a distinct
nosological entity. In 1988 in the US, the eighteen strong panel of
medical scientists and clinicians charged with formulating a new
case definition and new name could not agree: two of the most
experienced members refused to sign the final document and withdrew
from the panel because the proposed definition and new name were too
different from the ME with which they were so familiar. (109)
Those two members were Dr Alexis Shelokov from the US and Dr Gordon
Parish from the UK. Dr Parish now lives in Scotland and is curator
of the Ramsay Archive, which is possibly the world's largest
collection of medical papers on ME which pre-date 1988.
How "CFS" displaced ME in the
UK
At about the same time (1988) in
the UK, psychiatrist Simon Wessely rose to prominence.
Wessely leads a group of UK
doctors, mostly but not exclusively psychiatrists, who have
colloquially become known as the " Wessely School". (110)
Wessely is now Professor of Epidemiological and Liaison Psychiatry
at Guy's, King's and St Thomas' School of Medicine, London and at
The Institute of Psychiatry, where he is Director of both the CFS
Research Unit and the Gulf War Illness Research Unit. He is
well-known for his strongly-held beliefs that neither ME nor Gulf
War Syndrome exists, (111) and that such patients are
mentally, not physically, ill.
Since the late 1980s he and his
close colleagues have assiduously attempted to obliterate recorded
medical history by insisting that there is no such disorder as "ME",
claiming that previous studies of ME "reflect those who seek
treatment rather that those who suffer the symptoms", (112)
even though those studies were published in peer-reviewed
prestigious medical journals and span over sixty years.
Despite the fact that the
International Classification of Diseases is approved by all the
countries who are part of the World Health Assembly, Wessely
believes the WHO got it wrong about ME, writing in the Lancet:
"The inclusion in the tenth
revision of the International Classification of Diseases (ICD-10) of
benign myalgic encephalomyelitis as a synonym for postviral fatigue
syndrome under Diseases of the Nervous System seems to represent an
important moral victory for self-help groups in the UK. Neurasthenia
remains in the Mental and Behavioural Disorders chapter under Other
Neurotic Disorders. Neurasthenia would readily suffice for ME.
Applying more stringent criteria for CFS in the hope of revealing a
more neurological sub-group succeeds only in strengthening the
association with psychiatric disorders. We believe this latest
attempt to classify fatigue syndromes will prevent many people from
seeing the
world as it actually is". (113)
In the ICD classification the
section entitled "Mental and Behavioural Disorders" (section F-48.0
subtitled "Other Neurotic Disorders") includes "neurasthenia" and
"fatigue syndrome".
|
ME, CFS and PVFS are specifically excluded
from the psychiatric section F-48. |
Wessely's views of those afflicted
by ME / ICD-CFS are well-known, and may be summarised in just two
illustrations:
"The description given by a leading
(doctor) at The Mayo Clinic remains accurate: 'the doctor will see
that they are neurotic and he will often be disgusted with them' "
(114)
"There lies at the heart of CFS not
a virus (or) immune disorder, but a distortion of the doctor-patient
relationship" (115)
Wessely's determination to
eradicate ME as a legitimate medical entity seems never to cease.
Perhaps his most blatant attempt to change the WHO classification
from neurological to psychiatric can be found in his contribution to
the WHO Guide to Mental Health in Primary Care (November 2000)
in which ME is notoriously re-classified as a mental disorder.
Psychiatrists at King's College Hospital and The Institute of
Psychiatry are designated as one of the WHO Collaborating Centres
and as such are entitled to use the WHO logo. Use of the WHO logo
implies that contributions carry WHO sanction, but in this
particular instance, such is not the case and Wessely's actions
brought forth international condemnation. The WHO has confirmed that
what Wessely published about the classification of ME in the Guide
to Mental Health in Primary Care did not carry WHO approval, stating
"It is possible that one of the
several WHO Collaborating Centres in the United Kingdom presented a
view that is at variance with WHO's position". (116)
The present confusion has been
compounded by the fact that the term "CFS" has been included by the
WHO in the latest revision of the International Classification of
Diseases as one of the terms by which ME has become known. In
practice, this has come to mean that when referring to "CFS", some
doctors (mostly some UK psychiatrists led by Simon Wessely) are
talking about psychiatric illness involving "chronic fatigue",
whilst international experts are talking about ICD-CFS, which is
synonymous with ME.
It is important to be aware that
published international research on CFS (as distinct from UK
psychiatric research on CFS) reflects patients who are likely to
have ME rather than psychiatric disorder.
The essence of the confusion
concerns the use in the UK of the combined term "CFS/ME", given that
"CFS" means different things to different people.
On the one hand there is an
extensive published record by the UK "psychiatric CFS" school
promoting their view that ME no longer exists and that CFS (a term
they use interchangeably with chronic or long-term "fatigue"
(117),(118)) is a psychiatric (behavioural) disorder with no
physical signs which is perpetuated by aberrant "illness beliefs"
and "personality" (119) which is best managed by a
form of psychotherapy known as cognitive behavioural therapy (CBT)
and delivered according to a "management plan" administered by
psychotherapists. Wessely himself has published over 200 papers
mostly on his own view of CFS but his beliefs are not supported by
international experts and there is stringent criticism of his papers
in the peer-reviewed medical literature (see below).
On the other hand, ME /ICD-CFS is
formally classified as a neurological disorder in the WHO
International Classification of Diseases. The whole area of
terminology has become a minefield for the unwary, to the serious
detriment of patients.
This dichotomy has been summarised
by Fred Friedberg, Clinical Professor in the Department of
Psychiatry at the State University of New York:
"descriptive studies of CFS
patients in England, the US and Australia suggest that the CFS
population studied in England shows substantial similarities to
depression, somatization and phobic patients, while the US and
Australian research samples have been clearly distinguished from
depression patients and more closely resemble fatiguing neurological
illnesses". (120)
It is important to be familiar
with the fact that "chronic fatigue" and chronic "fatigue syndromes"
do not equate with chronic fatigue syndrome (CFS) or with ME.
Following an erroneous News Release
in 1990 about this point, the American Medical Association was
forced to issue a correction which said: "A news release in the July
4 packet confused chronic fatigue with chronic fatigue syndrome; the
two are not the same. We regret the error and any confusion it may
have caused. AMA Science News Editor: John Hammarley"
(121)
Wessely's beliefs, however, have flooded the UK literature; he is
adviser to the UK Government and to the Ministry of Defence and his
wife (psychiatrist and GP Dr Clare Garada) is Senior Policy Adviser
to the Department of Health.
Specifically, Wessely and those who
agree with him officially advise that no investigations should be
performed to confirm the diagnosis; (122) particularly, they
emphasise that immunological abnormalities (documented by worldwide
researchers as underlying the disorder) should not "deflect the
clinician from the (psychiatric) approach….and should not focus
attention towards a search for an 'organic' cause". In this
respect it is notable that it has been convincingly demonstrated
that changes in different immunological parameters correlate with
particular aspects of ME / ICD-CFS symptomatology and with measures
of disease severity, lending further support to the concept of
immunoactivation of T- lymphocytes. (123) Such findings seem
to be intentionally diverted by Wessely and his colleagues, who
officially advise Government that the performing of medical
investigations on patients with ME or CFS is neither necessary nor
appropriate and that doing so merely reinforces sufferers'
"dysfunctional belief" that they are physically ill, from which they
seek to obtain secondary gain in the form of sickness benefits and
from the relinquishing of personal responsibility for their imagined
ill-health.
Wessely and his associates ignore
the fact that ME is often confused with multiple sclerosis. (124)
They also ignore the evidence that ME /ICD-CFS has features of
autoimmune disorder and features of allergy and multiple chemical
sensitivity (MCS), (125),(126),(127),(128),(129),(130) which
is now officially recognised in the International Classification of
Diseases, (ref: ICD 10: SGBV:3.1:code T78.4: Chemical Sensitivity
Syndrome, Multiple). Data presented at the American Association
for Chronic Fatigue Syndrome (AACFS) Fifth International Research
and Clinical Conference in Seattle in January 2001 showed that MCS
was present in 42.6% of patients compared with 3.8% of controls.
(131) Wessely, however, asserts that MCS does not exist and that
along with fibromyalgia (in apparent contempt of the fact that FM is
formally classified as a legitimate physical disorder in the
International Classification of Diseases under Soft Tissue Disorders
ref ICD-10 M.79.0 ), conditions such as irritable bowel
syndrome, pre-menstrual tension, globus hystericus, tension headache
and chronic fatigue syndrome should all be classed as one entity
because, he claims, all occur more frequently in women and all are
associated with unnecessary expenditure of medical resources and are
afforded unjustified credibility largely because of "an artefact
of medical specialisation": Wessely believes this one entity to
be a psychiatric disorder which he terms a "functional somatic
syndrome". (132)
Psychiatrists who do not subscribe
to the "Wessely School" doctrine point out that "somatic syndromes"
are simply assumed to be without a physical cause, but this
assumption is never tested or validated; they advise that it is a
mistake to diagnose mental illness in people with ME / ICD-CFS
because of the unproven and incorrect assumption that their physical
complaints are of psychological origin. (133)
Wessely and colleagues also dismiss
the evidence that immune abnormalities documented in ME/ ICD-CFS
follow a recognisable, consistent and reproducible pattern, with
clear evidence of an immune activation state.
It is true that the immune system
dysfunction is not reflected in any of the currently used case
definitions, hence the international support for a name change.
Currently, the favoured choice supported by the internationally
renowned immunologist and ME /ICD-CFS expert Professor Nancy Klimas
(of the University of Miami) is for NEIDS or Neuro-Endocrine-Immune
Dysfunction Syndrome or for CNDS (Chronic Neuroendocrineimmune
Dysfunction Syndrome), both of which accurately reflect the nature
of the underlying organic pathoaetiology.
It may well be the case that ME is
one of the recognised conditions which are characterised by chronic
post-exertional fatiguability, but ME is different in clinical
presentation from other chronic fatigue syndromes. The evidence
speaks for itself. Other postviral fatigue states are clinically in
contrast to the three cardinal features of ME. (134) Other
fatigue states which may follow flu, measles, chickenpox, herpes or
mononucleosis lack not only the clinical but also the laboratory
features of ME. (135)
There are no less than nine case
definitions of CFS. (136) The two most commonly used (the UK
1991 Oxford case definition which was drawn up by Wessely and his
associates and the US 1994 CDC case definition, in the formulation
of which Wessely participated) both unequivocally state that
patients with CFS have no physical signs. In the US, in Australia
and on the Continent, such a stipulation is now accepted as being
unsatisfactory and apart from the UK (where the forthcoming Chief
Medical Officer's Report on CFS/ME (see below) is likely to state
that "on present evidence, (subgrouping CFS) may be considered a
matter of semantics and personal philosophy"), there is an
increasing clamour within the medical fraternity for the urgent need
to study sub-groups of "CFS" (137),(138),(139),(140),(141),(142)
because those with ME / ICD-CFS always do have observable physical
signs and abnormal immunological laboratory results.
The overriding difficulty is that
some clinicians in some medical disciplines apparently fail to see
them, have no desire to look for them or even deny their
significance and existence.
It is the case that some of those
doctors have been funded for many years by sources with links to the
same industry which manufactures the chemicals which may be
contributing to the rise in incidence of chemically-induced ME /
ICD-CFS. They have also been funded by the insurance industry and by
private interests such as The Linbury Trust which belongs to the
Sainsbury (supermarket) family.
Since 1991, the Linbury Trust has
funded over £4 million for research into CFS (which they call
"chronic fatigue"), almost all of it by Wessely and his psychiatrist
colleagues.
Since 1996, David Sainsbury (now
Lord Sainsbury of Turville) has donated £7 million to the UK Labour
Party. He is currently (until 2006) Minister for Science; as such, he has
responsibility for the Office of Science and Technology and the
Chemical and Biotechnology industries, as well as all the Research
Councils, including the Medical Research Council.
The MRC, itself often now funded by
partnership schemes with industry, is on record as regularly funding
research into "chronic fatigue" by psychiatrists and others who
subscribe to Wessely's views (who then claim that their results
relate to "CFS"), whilst regularly declining to fund applications
for research submitted by suitably qualified non-psychiatrists into
the physical basis of ME, claiming of those applications: "none
have been of sufficiently high scientific quality to merit funding".
(143)
This is notable, given that the
psychiatric research done by Wessely's close colleagues and
co-authors which the MRC has funded has been rigorously criticised
on the grounds that it is methodologically flawed and biased and
that it relies on a highly selective and misrepresentative choice of
references, including citing too many of their own studies as
references. (144),(145),(146),(147)
In a letter to Wessely (made widely
available), the Countess of Mar brought to his personal attention
the fact that questions have been asked about his methodology, the
selection of evidence he utilises, the obvious bias, and the lack of
balance and objectivity. (148) That same letter continued
"You must recognise that you
and your colleagues have an enormous influence on the treatment
meted out to a very large group of sick people. How you managed to
achieve this influence is a matter for conjecture".
The Office of Science and Technology monitors all government funding
of research grants and controls official science policy and it is
"policy" which determines the research which is funded: "The
Department funds research to support policy". (149)
It is the case that in 1998,
Wessely joined a Board of the Medical Research Council but it is
unthinkable that he would be asked to read, report on or referee
anything to do with his own work. It is also the case, however, that
from 1989 to 1992 the MRC granted the Institute of Psychiatry
£92,000 for research on "chronic fatigue".
Since 1988, psychiatrists of the
"Wessely School" have been funded not only by the MRC but by
Wellcome Training Fellowships in Clinical Epidemiology; by a
Wellcome Research Fellowship in Epidemiology; by the Wellcome Trust;
by ICI Pharmaceuticals; by Pfizer UK; by Duphar Pharmaceuticals; by
The Linbury Trust; by the Medical Policy Group of the Department of
Social Security; by the Department of Health; by Private Patients
Plan by BUPA and by the US Department of Defense.
If influential doctors can succeed
in portraying ME as non-existent and CFS as psychiatric in origin,
then the chemical companies and the governments who granted them
product licences would not be at risk of being accountable should
there turn out to be a provable link with the synergistic effects of
so many chemicals, daily exposure to which is now impossible to
avoid due to the huge increase in chemical usage. It is this
prevailing use of so many chemicals which is thought to be
chronically stimulating the immune system. (150)
In the shadows is also the massive
insurance industry, which cannot ever face liability for chemical
injury or environmental illness without considerable strain and even
collapse.
Accountability becomes more remote
if all research which demonstrates the link between chemicals and
the present upsurge in chemically-induced ME / ICD-CFS is blocked,
dismissed, trivialised, ignored or discredited.
As well as being advisors to the UK
Government, some of this same group of doctors are also known to
have indisputable long-term commitment to the insurance industry and
have acted as advisors to it, notably Professor Wessely and his
close colleague and co-author Michael Sharpe, also a psychiatrist
who claims to be a specialist in "CFS". Many illustrations could be
provided; only one is mentioned here. On 17 May 1995 both Wessely
and Sharpe were the main speakers at a symposium held at the London
Business School entitled "Occupational Health Issues for Employers"
at which they advised employers how best to deal with employees who
are on long-term sickness absence with "ME". Information presented
included informing attendees that ME/CFS has also been called "the
malingerer's excuse". Another speaker at this conference was Dr John
le Cascio, Vice President of UNUM.
Just three extracts from a copy of
UNUM's "Chronic Fatigue Syndrome Management Plan" seem
significant:
(i) Diagnosis: Neurosis with a
new banner
(ii) UNUM stands to lose
millions if we do not move quickly to address this increasing
problem
(iii) attending physicians
(must) work with UNUM rehabilitation services in an effort to return
the patient / claimant back to maximum functionality with or
without symptoms.
Apart from those mentioned, there
are other areas related to ME / ICD-CFS in which Wessely is known to
have special interests, none of which he usually declares.
One of these is PRISMA, which
stands for Providing Innovative Service Models and Assessments. It
is based in Germany and is a multi-national healthcare company
working with insurance companies; it arranges rehabilitation
programmes for those with "CFS" and its recommended management is
cognitive behavioural therapy, placing heavy emphasis on training
sufferers to "regain a normal life again". PRISMA claims to
be especially concerned with long-term disability from the
perspective of government, service providers and insurance
companies. It claims to have developed a "unique treatment
programme" for "hopeless" cases (it specifically includes
those with ME /CFS), claiming that such patients "avoid physical
exercise and social activities, as they fear these may trigger new
bouts of complaints". In the PRISMA Company Information,
Professor Simon Wessely is listed as a Corporate Officer. He is a
member of the Supervisory Board; in order of seniority, he is higher
than the Board of Management. He is listed as a "world expert"
in the field of "medically unexplained illnesses, including
Chronic Fatigue Syndrome". (151) Is it possible that
Wessely is recommending to the Chief Medical Officer a management
programme for "CFS" which is known to be harmful for those with ME /
ICD-CFS (152) and which is provided by a company of whose
Supervisory Board he is a member?
Another area with which Wessely is
known to be involved is the organisation now called HealthWatch, but
which used to be called The Campaign Against Health Fraud. This UK
organisation, now a charity, is known for its zealous views which
are antagonistic towards alternative and complementary medicine, and
towards those who believe in environmental and chemically-induced
illness, including multiple chemical sensitivity. It is a
campaigning organisation which in the past has accepted funding from
both pharmaceutical companies and the health insurance industry.
(153),(154) In the Campaign's own literature, it states that it
plans a programme of public information and that its aims are "to
oppose…unnecessary treatment for non-existent diseases". The
same document lists Simon Wessely as a "leading member of the
campaign", together with other doctors including other
psychiatrists and Dr David Pearson of Manchester. (155) It is
the case that Wessely asserts that ME is a "non-existent"
disease. (156),(157)
Pearson became notorious (158)
for his evidence for the Defence in the High Court in London in 1991
(159) in which he relied upon an unauthorised draft report
from the Royal College of Physicians entitled Allergy:
Conventional and Alternative Concepts despite a letter from
solicitors for the Royal College of Physicians (Field Fisher
Waterhouse) forbidding him to use it; the letter, dated 18th October
1991, stated "The College is not in a position to endorse the
contents or conclusions of the draft you have seen…we must ask that
this letter be brought to the attention of the Judge". The draft
report upon which Pearson relied in evidence was subsequently
subjected to stringent critical review and was withdrawn; it was
substantially amended on the grounds that Fellows of the College
found it to be wildly inaccurate and misleading, but the Judge (Mr
Justice McPherson) did not know this and found against the Plaintiff
(who could not obtain Legal Aid to mount an appeal). It is difficult
to know how significantly the Judge was influenced by the inaccurate
draft report, but it is likely that he would have been influenced by
an apparently prestigious report supposedly backed by the Royal
College of Physicians.
The HealthWatch website has links
to other Internet sites, including amongst others the Advertising
Standards Authority, a body which regulates advertising and which
HealthWatch members have used to discipline alternative therapy
practitioners; the American Council on Science and Health, a
powerful group which is sponsored by multinational industry
including pharmaceutical companies; the Association of Broadcasting
Doctors; the Food and Agriculture Organisation; Net Doctor; NHS
Direct Online; the UK Department of Health and the Cochrane
Collaboration (a sibling of the Centre for Reviews and Dissemination
based at the University of York, which carried out the review of the
literature for the Chief Medical Officer's forthcoming report and
which recommended cognitive behavioural therapy as "best practice"
management of CFS/ME.
The Chief Medical Officer has
himself confirmed in writing (160) that it was Wessely's own
database which formed the basis of that literature review; it is a
matter of record that Wessely himself was adviser to the team which
carried out the review).
The Chief Medical Officer's
Working Group on CFS/ME
In 1998 the UK Chief Medical
Officer (CMO) set up a Working Group to produce an official Report
on ME and CFS: many people hoped and believed that the aim was to
produce accurate information about the condition so that UK
clinicians would be brought up to date with current scientific
knowledge. In reality, the remit of the CMO's advisory group was
narrow: it was restricted to just one single aspect, namely to
advising UK clinicians as to the best way of managing the disorder,
it being acknowledged that currently, there is no effective
treatment.
Of special concern is the fact that
the remit specifically dictated that ME and CFS should be considered
as one entity: this has been particularly problematic, because the
most influential members of the Working Group are Simon Wessely and
his psychiatrist colleagues. Psychiatrists and those who agree with
Wessely's beliefs are heavily represented on the Working Group and
it is known that their beliefs about the nature and management of
the disorder have dominated the proceedings.
To the concern of many researchers
and clinicians, advice that only the most basic screening should be
carried out on patients with CFS/ME is likely to be enshrined in the
CMO's forthcoming Report, the final draft of which specifically
advises that no immunological tests and no nuclear medicine scans
should be carried out on patients suspected of suffering from
"CFS/ME" (even though it is these two areas which are delivering the
strongest evidence of organic pathoaetiology).
Also of concern is the fact that
whilst Deputy Chair of the CMO's Working Group on CFS/ME, Professor
Anthony Pinching of St Bartholomew's Hospital, London published an
article in Prescribers'Journal in which he asserted that
"over-investigation can (cause patients) to seek abnormal test
results to validate their illness". (161) Such views are
in stark contrast to those expressed by international researchers,
whose clear message is that basic laboratory testing is not
sufficient for patients with ME / ICD-CFS, and that more advanced
immunological and neurological tests are necessary. (162)
As long ago as 1994, world-renowned
ME/ ICD-CFS clinician and researcher Daniel Peterson stated in his
Introduction to an International Research and Scientific Conference:
(163)
"I take great issue with the
current recommendations that no additional testing should ever be
done. I believe there are indications for more advanced testing".
As recently as July 2001, the
American Medical Association issued a statement, explaining that 90%
of ME / ICD-CFS patients show normal test results on basic
investigations, and that studies designed for specific subgroups are
needed. Anthony Komaroff, Associate Professor of Medicine at Harvard
and an undisputed world expert on the disorder, said:
"Researchers are already using
imaging technology to measure brain hormones and are examining the
function of the immune system. There is considerable evidence
already that the immune system is in a state of chronic activation
in many patients with CFS". (164)
In the UK, it seems that clinicians
are to be advised that it is inappropriate and unnecessary even to
look for such pathology in those who are thought to have this
disorder.
The final draft of the CMO's
forthcoming report states that management is to be psychiatric
(cognitive behavioural therapy and graded exercise), and that future
NHS services for "CFS/ME" patients "ideally would adopt a
biopsychosocial model of care --- The components of such a service
are facilities for activity management".
In the final draft of November
2001, there is no recommendation (nor even any acknowledgment of the
need) for the urgent establishment of centres of excellence which
would provide facilities to look at the underlying immunology,
neurology, endocrinology or the molecular biology of ME / ICD-CFS,
but only for more psychiatric services; the need for provision of
in-patient care or suitable respite care for such very sick people
is notable by its absence.
Caution Needed by Clinicians
and Lawyers
It is essential to be ever mindful
of the fact that it is unsafe to assume that the most prolific
published author on a subject is necessarily the unquestioned expert
on that subject. This is especially true in relation to ME /
ICD-CFS, where Wessely is keen to promote himself as a medico-legal
expert. (165)
In any medical discipline, the
selective or multiple reporting of studies as if they were different
trials, sometimes by "shifting first authorship", makes it difficult
to detect duplicate publications in different journals: examples of
this practice in psychiatry include one trial which had been
published (in one form or another) in 83 separate publications.
(166)
Once again, however, medical
science is seeking to expose such deliberate manipulation of the
facts. Undeclared competing interests which in reality underlie
numerous published biomedical studies are again in the spotlight,
with editors of JAMA (Journal of the American Medical Association)
and the BMJ Publishing Group now looking for ways to ensure that the
studies which they publish are free from hidden bias. (167)
This supports the acknowledgment by medical science that the problem
not only exists but is considerable, and that it is essentially a
form of scientific misconduct. (168) In an Editorial in 2000
in the journal Psychological Medicine entitled "Publication Bias"
(169) Gilbody and Song state
"Despite psychological researchers
being the first to recognize the importance of publication bias
(Sterling, 1959), this issue has been all but ignored in the sphere
of mental health. Publication bias needs to be dealt with if
psychiatry is going to become more 'evidence-based'. The continued
existence of publication bias represents an abuse of the trust that
patients give and is essentially a form of scientific misconduct.
The recognition of the potential
consequences of publication bias has led to important advances in
its minimization and detection. However, these methods are rarely
employed when they should be in psychiatry. This is unfortunate
when, compared to other specialities, psychiatry is likely to be
especially prone to publication bias.
"The cornerstone of evidence-based
medicine is the belief that good quality research should form the
basis of clinical practice and decision-making. It is largely
published research that forms the 'knowledge base' of the evidence
movement. A fundamental difficulty arises when published research
results are a biased sample of all research results.
"A consequence is the danger that
readers of journals are more likely to see studies showing results
in a certain direction".
In the UK, nowhere is this more
pertinent than in the field of ME / ICD-CFS.
Conclusion
Clinicians and lawyers need to be
fully aware of the political undercurrents surrounding the reality
of ME, ICD-CFS and CFS.
They need to come to their own
conclusions about what might motivate a group of doctors to
disassemble a formally classified neurological disorder and
endeavour to replace it by a much larger category of psychiatric
"behavioural" illness.
They need to consider how, despite
there being such an extensive worldwide literature on the organic
nature of ME / ICD-CFS, a group of UK doctors has come to exert such
influence over the rest of the UK medical community to the extent
that discussion of the biomarkers of serious organic pathology is
rarely published in the UK medical journals, with the result that UK
clinicians are effectively being deprived of the opportunity to
obtain an informed and balanced over-view of the reality of their
patients' suffering, as the literature they are most likely to see
reflects only the views of Wessely and his associates.
Lawyers may wish to reflect on some
of the practical consequences of the denial of ME / ICD-CFS; these
include:
- refusal and denial of state
benefits: those with a psychiatric diagnostic label are denied the
higher rates of some state benefits and do not usually qualify for
the Disability Living Allowance (DLA), which requires that the
recipient has a physical disability
- difficulties in obtaining
insurance benefit if unable to work through ill-health (some health
insurance companies expressly exclude psychiatric illness)
- difficulties in obtaining
private health care insurance (again, some companies do not provide
cover for psychiatric disorders)
- difficulties in obtaining early
retirement on health grounds
- unfit patients are forced to
return to work
- inappropriate treatment (some
ME sufferers have been threatened with being sectioned under the
Mental Health Act unless they comply with psychiatric treatment)
- withdrawal of Out of Area
Treatment / Transfers for those with ME / ICD-CFS (necessary if no
suitable clinician is available within the patient's own Health
Authority area; there is a marked lack of appropriate referrals, eg
to neurologists, immunologists endocrinologists etc )
- lack of appropriate service
provision within the NHS
- special problems for children
and young people with ME.
Lawyers may wish to consider that
on 23rd November1999 the House of Commons Select Health Committee
produced its report looking at adverse clinical incidents,
unexpectedly poor outcomes to treatment, failures in medical care,
poorly-performing doctors and the NHS complaints procedures; the
Select Committee took evidence and representations from at least
eight people about ME. (170) opnent Leadi Cnsel (a
member of the House of Lords) has been obtained and that this
Opinion is unequivocal. It states:
" On the document you have sent me
there is an overwhelming case for the setting up of an immediate
independent investigation as to whether the nature, cause and
treatment of ME as considered by the Wessely School is acceptable or
consistent with good and safe medical practice.
" There is substantial doubt as to
whether such could be the case in view of the clear division of
medical opinion.
"A formal request should be made to
set up such an enquiry, at which interested parties could be
represented by Counsel. It is all but essential that a reputable
firm of solicitors should be instructed: an approach to Lord Mishcon
would be well advised". (171)
Lawyers may wish to consider if
a small group of exceptionally influential doctors should be allowed
to determine public policy without there being some external
moderation.
They may wish to consider why
disease definition has become socially constructed, resulting in
political tensions between sufferers, medical science and the modern
State, a consequence of which is the intentional construction of
"mental illness" by some groups of medical professionals resulting
in stigma caused by the on-going denial. (172)
If clinicians and lawyers are
unaware of this background and accept the readily proffered
psychiatric explanations as if objective and based on sound
scientific research, they will be unable to support their patients /
clients with ME / ICD-CFS and will risk failing in their
professional duty in this difficult area.
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