In her
BMJ editorial in which she referred to “myalgic encephalitis”
instead of the correct term “myalgic encephalomyelitis” (Ending
the stalemate over CFS/ME: BMJ 2011:342:d3956), Fiona Godlee
described the disagreement between the biomedical and
psychosocial schools of thought about ME as
“an unproductive
standoff in which…all progress is being stifled by increasingly
aggressive intimidation of researchers”. |
The
“unproductive standoff” certainly existed and may be said to
be the result of 25 years of inflexible arrogance by “overly
powerful psychiatrists who hold key positions in medicine,
research, media gatekeeping and government policy…suppressing
the argument that ME may be biomedical rather than psychiatric”
(Let psychiatric and biomedical lobbies be heard equally in
CFS/ME research; Caroline Davis: BMJ 2011:343:d4544).
Following her editorial, Godlee published a letter from
Professor Peter White (Chief Principal Investigator of the
notorious PACE Trial) in which he was joined by Alastair Miller
(medical advisor to the charity Action for ME) and by
paediatrician Esther Crawley (renowned for her belief in the
Lightning Process in the management of ME) in which they decried
the need for adequate assessment of patients with ME as being
“a significant burden” on both patients and doctors.
When
did careful assessment of sick people stop being part of the
practice of medicine, particularly when the disorder in question
is known to be both complex and chronic? The answer seems to be
that it was when Wessely School psychiatrists and others who
work for the insurance industry became the arbiters of what
constitutes disease or disability.
In
their published letter, White et al use inverted commas when
referring to “symptoms” of ME such as “ataxia” and
“palpitations with cardiac arrhythmias” and “loss of
thermostatic stability”, denoting their dismissal of such
symptoms as genuine components of ME; indeed, White et al go on
to refer to the assessment of “too many symptoms of dubious
validity”.
Godlee
also afforded a platform for psychiatrist Alastair Santhouse
(who, with Esther Crawley, was a member of the Guideline
Development Group that produced the NICE Clinical Guideline on
“CFS”) to reject valid criticisms of the PACE Trial (“the
sound rebuttal by the Medical Research Council and the Lancet to
allegations that the PACE trial was in some way improper should
be proof enough” – BMJ 2011:343:d4550).
However, a positive step has just been taken towards resolving
the “standoff”.
Not
only were researchers from 13 countries including the UK
not
intimidated by their patients with ME, they have now produced
International Consensus Criteria specifically for ME (ME:
International Consensus Criteria; Bruce M Carruthers et al;
Journal of Internal Medicine: Accepted Article:
doi:10.1111/j.1365-2796.2011.02428.x).
Between
them, the international panel have about 400 years of both
clinical and teaching experience of ME; they have authored
hundreds of peer-reviewed publications and they have diagnosed
or treated approximately 50,000 (fifty thousand) ME patients.
The
abstract is clear:
“In view of more recent research and clinical
experience that strongly point to widespread
inflammation and multisystemic neuropathology, it is
more appropriate and correct to use the term
‘myalgic encephalomyelitis’ (ME) because it
indicates an underlying pathophysiology. It is also
consistent with the neurological classification of
ME in the World Health Organisation’s International
Classification of Diseases (ICD G93.3)”. |
The
expert authors explain that the purpose of developing the latest
international criteria was to base them on current knowledge of
ME that reflects the complex symptomatology and they have
produced guidelines which “promote optimal recognition of ME
by primary care physicians and other health care providers”.
The
authors point out that ME “is a complex disease involving
profound dysregulation of the central nervous system and immune
system, dysfunction of cellular energy metabolism and ion
transport, and cardiovascular abnormalities”.
They
note that the use of overly inclusive criteria in research has
included people who do not have ME and that this leads to
“biased research findings, inappropriate treatments, and waste(d)
scarce research funds”.
The
International Consensus Criteria are soundly supported by
research and are based on 123 cited references; the authors note
that broadly based studies show a lack of objective findings and
state that “the primary goal of this consensus report is to
establish a more selective set of clinical criteria that would
identify patients who have neuroimmune exhaustion with a
pathological low threshold of fatigability and symptom flare in
response to exertion”.
The
authors are explicit:
“Pain and fatigue are crucial bioalarm signals
that instruct patients to modify what they are doing
in order to protect the body and prevent further
damage. Post-exertional neuroimmune exhaustion is
part of the body’s global protection response and is
associated with dysfunction in the regulatory
balance within and between the nervous, immune and
endocrine systems, and cellular metabolism and ion
transport”. |
The
panel members consider the neurological impairments including
structural and functional abnormalities seen on neuroimaging
studies in ME; they address the immune impairments including
decreased natural killer cell signalling and function; abnormal
growth factor profiles; decreased neutrophil respiratory bursts
with a shift towards a Th2 profile; chronic immune activation
with increases in inflammatory cytokines, pro-inflammatory
alleles, chemokines and T lymphocytes, and dysregulation of the
antiviral ribonucelase L (RNaseL) pathway.
They
consider the evidence of profound energy impairment and poor
cardiac performance and they note the possible involvement of
altered control and reduced cortisol production during and after
exercise.
They
note the evidence of abnormal blood pressure regulation and the
measurable vascular abnormalities that suggest the brain is not
receiving sufficient circulating blood volume when the patient
is upright and that this is intensified when standing in one
place such as in a grocery checkout line.
The
authors discuss the clinical application of their criteria, as
well as paediatric considerations and research applications.
The
authors conclude that they “believe the International
Consensus Criteria will help clarify the unique signature of ME”
and they state unambiguously that “individuals meeting the
International Consensus Criteria have myalgic encephalomyelitis
and should be removed from the Reeves empirical criteria and the
National Institute for (Health and) Clinical Excellence (NICE)
criteria for chronic fatigue syndrome”.
This
approach could not be more different from that used by Professor
White in the PACE Trial, in which he used the intentionally
broad Oxford criteria that do not discriminate between ME and
chronic medically unexplained fatigue.
The
adoption of these international diagnostic criteria would ensure
that future studies are investigating people with well-defined
ME and would thus satisfy one of the biggest complaints from
within the ME community (ie. that previous studies have not been
looking at a homogeneous group of ME patients). It would
certainly be a positive step towards resolving the standoff
between science and psychiatry.