|
Four forthcoming events may significantly
affect the lives of people with ME/CFS:
-
the results of the MRC
PACE Trial on “CFS/ME” are expected to be published soon;
-
the
General Medical Council (GMC) is shortly to decide whether or
not to launch a full inquiry into the alleged misleading of the
High Court during the Judicial Review of the NICE Clinical
Guideline 53 by a member of the NICE Guideline Development Group
(GDG);
-
on 29th November 2010 the Fatigue Service at St
Bartholomew’s Hospital will hold a training day and a birthday
party in the Great Hall of Barts to celebrate 25 years of
Professor Peter White’s services to those with “CFS/ME”
-
and in
December 2010, using the same GDG members, NICE is to consider
if there has been any new research that necessitates a revision
of its much criticised 2007 Guideline CG53 on “CFS/ME”.
The common thread between these events
is, of course, the beliefs of the Wessely School about ME/CFS
(which they invert and refer to as “CFS/ME”) and their continued
refusal to engage with the extensive biomedical and scientific
knowledge about ME/CFS that identifies damage, deficits and
dysfunction in major bodily systems, particularly in the
neurological, immune, endocrine and cardiovascular systems.
At the Barts Fatigue Service
celebrations, Professor Wessely’s talk is entitled: “Where we
were then, where we are now” and Professor White is to speak on:
“PACE Trial: is knowledge more useful than belief?”
Is knowledge more useful than belief?
Not, it seems, where ME/CFS is concerned.
Why not? Because where the Wessely
School is now in relation to ME/CFS is little different from
where it was 25 years ago – their beliefs remain static and they
have resolutely not moved forwards in the light of knowledge.
They perversely and irrationally reject
the ever-increasing body of biomedical knowledge that ME/CFS is
a serious neuroimmune disease and continue to believe that it is
a somatoform disorder which is curable by their favoured
interventions of cognitive restructuring and incremental aerobic
exercise. Professor Peter White claims that “a full recovery is
possible” (Psychother Psychosom 2007:76(3):171-176); the PACE
Trial CBT participants’ Manual informs people that the PACE
Trial therapies are curative, and it is elsewhere asserted that
“many people have successfully overcome their CFS/ME” with such
behavioural interventions (“Information for relatives, partners
and friends”, page 123).
Such a belief is not supported by
knowledge.
With the publication of the PACE Trial
results being imminent, it is worth recalling the
already-published results of its sister trial, the FINE Trial
(Fatigue Intervention by Nurses Evaluation) that was funded
entirely by the MRC and had 296 participants: the FINE Trial was
a resounding failure on all fronts, so it is difficult to see
how the PACE Trial results might be glowingly successful.
The FINE Trial results clearly showed
that “pragmatic rehabilitation” (PR, based on CBT/GET) was
minimally effective in reducing fatigue and improving sleep: it
did so only whilst participants were engaged in the programme
and there was no statistically significant effect at follow-up.
Furthermore, pragmatic rehabilitation had no statistically
significant effect on physical functioning; equally, its effect
on depression had diminished at follow-up. Moreover the other
intervention being tested (“supportive listening” or SL) had no
effect in reducing fatigue, improving physical functioning,
sleep or depression.
Notwithstanding, the investigators are
already seeking further funding to test their hypothesis that
providing more sessions might improve the effectiveness of
pragmatic rehabilitation which they state “will inform the next
phase of our work….The first phase of this work will be in
conjunction with the Greater Manchester CFS Service”.
The PACE and FINE Trials, as well as the
recommendations in the NICE Guideline CG53, were predicated on
the Wessely School’s beliefs, not on existing biomedical
knowledge.
The existing knowledge is that the
interventions do not work, but the belief of the investigators
is that they ought to work, thus belief triumphs over knowledge.
Of particular note is what Professor
Wessely said on 26th July 2010 during the final of “Debating
Matters” filmed in India. The subject was “Alternative Medicine
is Quackery”; discussing people who make what he regards as
false claims about the success of alternative medicine and
comparing them with the scientific rigour of modern medicine,
Wessely said, apparently without a trace of insight: “They do
not change their beliefs or their practice on the basis of the
evidence, that’s the difference that we’re talking about. It’s
the ability to move from dogma to science and to say yeah, it
sounded good at the time, but the evidence shows that it isn’t,
so we move on, we research, we try and progress, that’s the
difference we’re talking about” (http://www.spike.com/video/alternative-medicine/3439367).
It has been said, and might still be said, that this is
precisely the argument that has been levelled against the
Wessely School in relation to ME/CFS – the behavioural
modification approach may have sounded good at the time, but the
evidence shows that it isn’t, so it’s time to move on. They,
however, refuse to do so and steadfastly hold on to their own
blind beliefs. The tragedy for people with ME/CFS is that the
Wessely School seem unable to apply the same logic they require
of others to themselves.
In relation to the GMC, if the complaint
about the GDG member is upheld, it would, according to one of
the lawyers “be strong grounds for re-opening the (Judicial
Review) and would seriously undermine NICE”.
Eight years before the NICE Clinical
Guideline 53 was published, the British Medical Journal carried
a compelling article on Clinical Guidelines (Potential benefits,
limitation, and harms of clinical guidelines; Steven H Woolf et
al; BMJ 1999:318:527-530).
The article provides a clear warning of
the dangers arising from an uncritical adherence to clinical
guidelines:
|
“Over the past decade, clinical
guidelines have increasingly become a familiar part of clinical
practice. Every day, clinical decisions…and health spending by
governments and insurers are being influenced by guidelines”. |
|
“Many believe that the economic motive
behind clinical guidelines is the principal reason for their
popularity”. |
|
“The most important limitation of
guidelines is that the recommendations may be wrong”. |
|
“Practices that are sub-optimal from the
patient’s perspective may be recommended to help control costs,
serve societal needs, or protect special interests (those of
doctors…or politicians, for example)”. |
|
“The promotion of flawed guidelines by
practices, payers, or healthcare systems can encourage…the
delivery of ineffective, harmful or wasteful interventions”. |
|
“Recommendations that do not take due
account of the evidence can result in sub-optimal, ineffective,
or harmful practices”. |
|
“Flawed clinical guidelines harm
practitioners by providing inaccurate scientific information and
clinical advice, thereby compromising the quality of
care….Outdated recommendations may perpetuate outmoded
practices”. |
|
“Guidelines can harm medical
investigators and scientific progress if further research is
inappropriately discouraged”. |
|
“Guidelines developed by specialists may
seem to be self-serving (and) biased”. |
|
“Naïve consumers of guidelines accept
official recommendations on face value, especially when they
carry the imprimatur of prominent professional groups or
government bodies. More discerning users of clinical guidelines
scrutinise the methods by which they have been developed”. |
|
“…those concerned with improving quality
should redirect their efforts to identify the specific
barriers…that stand in the way of behaviour change”. |
The evidence for retroviral involvement
in ME/CFS is becoming impossible for NICE to dismiss.
For
example, from 1st November 2010 there is to be a lifetime ban in
the UK on people with ME/CFS donating blood, a paradigm shift
that was reported nationwide and worldwide, even in The
Himalayan Times(http://www.thehimalayantimes.com/fullNews.php?headline=ME+sufferers+banned+from+donating+blood&NewsID=260959)
so NICE cannot claim to be unaware of the significance of it.
Moreover, given the known intercourse between the UK and the US
about ME/CFS, NICE can hardly be unaware that world experts in
ME/CFS such as Professor Nancy Klimas (principal investigator of
the National Institute for Health’s Centre for Multidisciplinary
Studies of (ME)CFS Pathophysiology at the University of Miami)
are clear:
|
“…there is a chronic inflammation,
neuro-inflammation, and it upsets the whole balance of your
systems…the patients become terribly ill…. The immune system is
really cranked up; it’s a tremendous amount of inflammation. I
think that if doctors could get this in their heads that it’s
sort of like lupus or one of these really inflammatory
disorders…it is that level of inflammation. There’s a
tremendous amount of inflammatory stuff going on, and there’s a
lot of inflammation in the brain itself” (http://www.litemiami.com/spotlite/index.aspx)
[Also Invest in ME International ME/CFS Conference 2010 DVD] |
The evidence of inflammation in people
with ME/CFS is important because the incremental aerobic
exercise recommended by the Wessely School and encapsulated in
NICE’s Clinical Guideline 53 is contra-indicated in cases of
inflamed and damaged tissue and inevitably results in post-exertional
relapse with malaise, which is the cardinal symptom of ME/CFS.
Can NICE credibly continue to ignore the
warning that was carried in the BMJ eleven years ago about the
harm caused by flawed guidelines, or will it continue to prefer
belief to knowledge?
Do entrenched beliefs that continue to be
held in defiance of knowledge cause harm to patients?
Countless people with ME/CFS and their
families know the answer to that question.
|
)