http://www.meactionuk.org.uk/Can-the-MRC-PACE-Trial-be-justified.htm
Can the MRC PACE Trial be justified
Margaret Williams=A0=A0=A0=A0 17th December 2009
In March 2003 the House of Commons Select Committee on Science and
Technology produced its Report "The Work of The Medical Research =
Council"
(HC 132) in which MPs issued a damning judgment on the MRC, lambasting =
it
for wasting funds and for introducing misguided strategies for its
research.=A0 The Select Committee had received seven representations =
about the
MRC's refusal to heed the biomedical evidence about ME/CFS. MPs found
evidence of poor planning and of focusing on "politically-driven" =
projects
that have diverted money away from top-quality proposals.=A0 The =
unprecedented
attack was the result of a detailed probe into the workings of the MRC. =
In
particular, MPs questioned why the MRC was content to support policies =
and
projects that are likely to perpetuate such criticism.=20
Given that biomedical research, including gene research (which has shown
that in people with ME/CFS, there are more gene abnormalities present =
than
are found in cancer sufferers) has demonstrated that the psychiatrists =
who
hold such sway at the MRC are comprehensively wrong about ME/CFS, =
nowhere
could such criticism be more apposite than in relation to the PACE =
Trial.
Patients with ME/CFS and their families are in despair, because no-one =
in
authority in the UK seems to be listening: as Mike O'Brien MP, Minister =
of
State for Health, made plain at the APPGME meeting on 2nd December 2009,
Ministers can no longer tell agencies of State what to do. This =
apparently
means that, no matter what conclusions are arrived at or what
recommendations are made or what evidence is put before a Minister, the
Minister concerned can deny having any power to implement change. The
Minister himself is reported to have said that he could not require the =
MRC
to undertake research in any specific field, nor could he require =
Primary
Care Trusts to follow Ministerial command.=A0 As far as ME/CFS is =
concerned,
it seems that there is nothing the Government can=A0 -- or will - do =
about the
current situation.
It is apparent that the Government feels no duty of care towards those =
whose
life has been devastated by ME/CFS, a situation that is borne out by
Professor Stephen Holgate's confirmation at the Royal Society of =
Medicine
Meeting on 11th July 2009 (Medicine and me; hearing the patients' voice)
that the Government will not permit integrated research into ME/CFS.
This can only mean that the influence of the Wessely School over the =
lives
of people with ME/CFS will continue and that their tactics of denial =
will
remain unchallenged, no matter what the calibre of the biomedical =
evidence
showing them to be wrong. As people recently drily commented on an ME =
group,
those tactics include:
"load up your committees with your biased friends and pretend they are
offering a fresh look; give really negative scorings to biomedical
applications; try to stop biomedical papers getting published in the =
better
known journals; make sure to keep on publishing psychiatric rubbish to =
bias
the general medical population and scientific community against any =
other
explanation, and give the impression that CBT/GET is all that is needed =
i.e.
no need to waste all that money on silly biomedical projects"
(LocalME@yahoogroups.com=A0 6th December 2009)=A0 and
"ensure you use the sketchiest diagnostic criteria you can get away =
with;
wherever possible, avoid seeing / talking to patients at all; never =
discuss
/ involve the severely affected; avoid using objective outcome measures;
rotate the name of lead authors on papers and ensure you include plenty =
of
reference papers from your psychosocial mates=85."=A0 =
(LocalME@yahoogroups.com=A0
7th December 2009).
As others have noted, the strategy is (1) to ignore ME; (2) to ensure =
that
CFS is seen as a problem of false perception, then (3) to reclassify
"CFS/ME" as a somatoform disorder (Co-Cure NOT:ACT: 12th January 2008),
which is far removed from the reality of ME/CFS, the CNS dysfunctions of
which are described by Dr Byron Hyde as=A0 being caused by "widespread,
measurable, diffuse micro-vasculitis affecting normal cell operation and
maintenance=85.The evidence would suggest that ME is caused primarily by =
a
diverse group of viral infections that have neurotropic characteristics =
and
that appear to exert their influence primarily on the CNS arterial bed"
(ibid).
Patients and their families, many clinicians and researchers are well =
aware
of such strategies and tactics but=A0 -- so powerfully has the Wessely =
School
myth about ME/CFS been promulgated -- have been unable to halt them.=20
As Dr Jacob Teitelbaum reported, the XMRV virus study clearly documents =
that
(ME)CFS is validated within the mainstream medical community as a real,
physical and devastating illness, "again proving that those who abuse
patients by implying that the disease is all in their mind are being =
cruel
and unscientific=85Though the economics may cause a few insurance =
companies to
continue to unethically deny the science, so they can avoid paying for =
the
health care and disability costs they are responsible for, this research
should speed up understanding of the illness.=A0 Meanwhile, for those =
with the
illness, their families and their physicians, it is now clear that this =
is a
real and devastating illness" (Co-Cure RES: 4th December 2009).
There can be no doubt that, for patients with ME/CFS as distinct from =
those
suffering from chronic "fatigue", neither CBT nor GET is effective,
otherwise everyone would by now be cured.
How, for instance, does the Wessely School's "CBT model of CFS" accord =
with
the fact that in the South African epidemic, all the rats that were =
injected
with the urine of ME patients died, but not a single rat died that was
injected with the urine of controls?=A0 The Wessely School's answer is =
likely
to be that "epidemic ME" is not the same as present day "CFS/ME", an
explanation that does not withstand scrutiny, given that the only =
symptoms
of "CFS/ME" on which the Wessely School focus are those that are known =
to
occur in mental disorders (tiredness, anxiety, depression and mood
disorders, the latter being a consequence, not a cause, of ME/CFS), =
whilst
ignoring, dismissing or wrongly attributing symptoms such as vertigo,
post-exertional physiological exhaustion, intractable pain, =
neuromuscular
in-coordination and dysautonomia to "hypervigilance" to "normal bodily
sensations", a=A0 situation best described as iatrogenic abuse.
As clinical psychologist Carl Graham recently pointed out, the type of =
CBT
"used in psychoneuroimmunological interventions is not limited to =
changing
'irrational beliefs' ", noting: "The view that all those involved with =
CBT
based treatments accept the idea that irrational thinking had led to a
somatoform disorder in a patient who has a chronic disease is entirely
unfortunate"=A0 (Co-Cure NOT 14th December 2009) and in an update =
(Co-Cure
15th December 2009) the same psychologist referred to "the association =
of
CBT with the very unfortunate tendency of some in the treatment field to
claim ME/CFS is a somatoform or psychiatric disorder", concluding that =
he
was "not advocating for CBT based practices for chronic health problems =
to
continue where they are being done poorly or as a monotherapy".
To change what they regard as "irrational beliefs" of people with =
"CFS/ME
is, however, the expressed intention of the PACE Trial Investigators, =
who
continue to promote CBT/GET as a monotherapy for "CFS/ME", a matter of
concern to experts such as Dr David Bell from the US, who on 12th =
December
2009 was quoted in The Daily News online (http://bit.ly/4KofDR): "'The
tiredness linked to (ME)CFS is caused by a reduction of blood flow to =
the
brain'=A0 Bell said.=A0 The doctor said the blood flow in people with =
severe
cases of (ME)CFS can be as low as people with terminal heart =
disease".=A0
Would people with terminal heart disease be required to undergo
psychotherapy to convince them they are not in fact sick, but only =
believe
that they are sick?
The apparent intention of the PACE Trial Principal Investigators to =
remove
people with ME/CFS from receipt of state and insurance benefits raises a
larger question than just welfare reform.=A0 It is also about the way =
illness
is being redefined and reclassified and about why this is happening and
about what forces are at work in this process of redefinition.
As recently noted by Overton (Psychological Medicine 2010:40:172-173; =
online
08.10.09), in Sharpe et al's 2009 study (Neurology out-patients with
symptoms unexplained by disease: illness beliefs and financial benefits
predict one-year outcome), one of the authors (Stone) accepts that terms
such as 'functional weakness' may well need to be re-worded as =
'conversion
disorder' on official documents.=A0 Challenging Sharpe's assertion that =
their
data lend "support to the idea that interventions which change these
variables [ie. state benefits or opposition to physician-imposed
psychological explanations of physical symptoms] may improve the outcome =
for
this patient group", Overton points out that Sharpe et al inadvertently
infer that patients with "symptoms unexplained by disease" are guilty of
benefit fraud and Overton states that it is erroneous for Sharpe to use =
data
in the way he does to assert that "Illness beliefs and financial =
benefits
are more useful in predicting poor outcome than the number of symptoms,
disability and distress". Moreover, Sharpe's assertion contrasts with =
the
evidence of Rosata & Reilly who, unlike Sharpe, correlate the level of
benefit with the degree of disability (Health & Social Care in the =
Community
2006:14:294-301).=20
In their Editorial in the Journal of Psychosomatic Research (Is there a
better term than 'Medically unexplained symptoms?' 2010:68:5-8, Epub =
ahead
of print), two of the MRC PACE Trial Principal Investigators, Professors
Sharpe and White, clearly state their intention to claim medically
unexplained symptoms (MUS -- in which they include ME/CFS) as =
psychosomatic
disorders by stating that the term "functional somatic disorder" fulfils
most of their own criteria for re-branding somatoform disorders (those
categories being "bodily distress or stress syndrome", "psychosomatic or
psychophysical disorder", and "functional syndrome or disorder"). Sharpe =
and
White et al continue: "All too often, these patients receive one-sided,
mostly purely biomedical=85treatments=85.Although some existing =
treatment
facilities include both biomedical and psychological therapies=85they =
are not
appropriate for =85the majority of patients with the type of symptoms =
with
which we are concerned here. Therefore, some specific treatment =
facilities
have been developed (eg. Chronic Fatigue Clinics in the UK)=85.The
terms=85'psychosomatic' or 'psychophysical' are helpful in providing a
positive explanation of the symptoms=85Alternatively, the term =
'functional
somatic syndrome' allows explanations=85in terms of altered brain
functioning=85demonstrating that the symptoms are 'real' and yet =
changeable by
alteration in thinking and behaviour as well as by a psychotropic drug".
There could be no clearer confirmation that the UK "CFS" Clinics =
allegedly
for patients with ME/CFS that were set up under the guidance of =
Professor
Anthony Pinching were and remain intended to change patients' thinking =
and
behaviour, which vindicates the countless patients whose damaging
experiences and legitimate concerns have been collated by Research into =
ME
(RiME NHS Clinics Folder=A0 -- www.erythos.com/RiME ).=20
As noted by Horace Reid (http://www.meactionuk.org.uk/Wessely-axis.htm =
),
seventeen years after the 1992 CIBA Symposium on CFS, members of the =
Wessely
axis are still promoting their agenda identified in the secret MRC =
document
in which that Symposium was summarised
(http://www.meactionuk.org.uk/The-MRC-secret-files-on-ME.htm).=A0=20
For example, in a 2008 paper comparing "chronic fatigue" in Brazil and
Britain, Cho and Wessely et al could not have been more explicit: =
"British
patients were more likely to be a member of a self-help group and to =
have
had sick leave / sickness benefit because of CFS, variables claimed to
predict poor outcome=85The greater public and medical sanctioning of =
CFS/ME
and the more favourable economic climate in the UK may lead to greater
access to sick leave / benefits for patients with chronic =
fatigue=85.There is
also evidence of an association between the so-called 'secondary gain' =
and
health outcomes=85.Therefore, the higher availability of sick leave / =
sickness
benefit because of CFS in the UK may both contribute to and reflect the
greater 'legitimisation' of chronic fatigue as a medical disorder" =
(Physical
or psychological? A comparative study of causal attribution for chronic
fatigue in Brazilian and British primary care patients.=A0 Acta =
Psychiatr
Scand 2008:1-8). Reid noted how the article reflected the MRC-funded =
PACE
Trial of CBT and GET as set out in the Trial Protocol that was published =
in
BMC Neurology (2007:7:6): "Predictors of outcome: Predictors of a =
negative
response to treatment found in previous studies include=85membership of =
a
self-help group, being in receipt of a disability pension, focusing on
physical symptoms and pervasive inactivity" (3,18,19).
There is no mention in that paper of on-going viral infection but, =
perhaps
expediently, in a paper that came out about the same time as the XMRV =
news
broke, Wessely quietly inserts his own new model that allows for =
infection
as a perpetuating factor, so the Wessely School goal-posts may be subtly
shifting: "=85a model of the aetiology of CFS can be constructed from a
combination of pre-morbid risk, followed by an acute event leading to
fatigue, and then a pattern of behavioural and biological responses
contributing to a prolonged severe fatigue syndrome.=A0 Based on this =
model,
the initial cause of the fatigue has a limited impact on the eventual =
course
of the illness=85.However, there is emerging evidence which suggests =
that it
may be appropriate to extend it to encompass fatigue with an apparent
medical cause=85.it may be that the divide between fatigue secondary to
diagnosed medical problems and CFS may need to be made more permeable"
(Chronic fatigue syndrome: identifying zebras among the horses. Samuel B
Harvey and Simon Wessely. BMC Medicine 2009:7:58).
This is very different from the PACE Trial concept of "CFS/ME" which, in
over 2,000 pages of information obtained under the Freedom of =
Information
Act, including all the Manuals, does not allow for any on-going =
pathology.
Because ME/CFS is a targeted disorder for the withdrawal of state =
benefits,
the situation for ME/CFS patients in the UK is increasingly dire, with
severely affected patients being harassed by the Department for Work and
Pensions requiring a 60-page booklet to be completed because the DWP
menacingly informs such patients: "We have reason to believe that you =
are
capable of work".
An article entitled "Mistaken Illness Beliefs=85" by David Lees =
published in
the ME Association's magazine "ME Essential" (Winter 2009: 34-35) =
admirably
captures the situation:
"=85a friend with ME=85was told, despite the persistence of her =
symptoms, that
the only thing preventing her full recovery was her 'mistaken illness
beliefs'=85.'But doctor, I still have nausea / muscle pain / severe =
weakness /
headaches / exhaustion etc' can all be met with 'It's just your illness
beliefs.=A0 There's nothing else wrong, and if you still experience =
symptoms,
it's because you haven't got your beliefs right yet.=A0 As soon as you =
do,
you'll be well'=85.It's impregnably self-immunised (referring to Sir =
Karl
Popper's 'self-immunisation' theory which showed that such theories are
scientifically worthless because they have no real explanatory or =
predictive
power) and therefore scientifically worthless as a =
diagnosis=85=85(Referring to
researchers who are struggling to uncover complex mechanisms and to =
answer
difficult and involved questions, Lees continues): Uncertainty and =
humility
are appropriate attributes in these circumstances and they seem =
noticeably
lacking in much of the psychological approach to diagnosis and treatment =
of
ME=85..Doctors are presented with difficult, confused, uncertain data =
and
interpretation can be very difficult; but surely this is an argument for
more caution and admissions of uncertainty rather than a reason to make
scientifically dubious statements with Olympian self-certainty=85In the
absence of proper research evidence, to work from the assumption that =
the
illness is not primarily organic in origin and must therefore be =
primarily
psychological is unscientific=85We should surely have moved on from =
filling
gaps in our medical knowledge with assertions=85the least we should =
expect
from medical practitioners in the NHS, whose diagnosis profoundly =
affects
the lives of those with ME, is that their methods and conclusions should =
be
scientific.=A0 The diagnosis of 'mistaken illness beliefs' is not - it =
is
itself merely a statement of belief".
Given the significant opposition to the PACE Trial from many quarters,
including both patients and professionals and also including the ME
Association (the oldest ME charity) and, it is understood, from many =
patient
members of the charity Action for ME (though not the charity's Trustees, =
who
support the PACE Trial, which seems to indicate that AfME is not a
patient-led organisation), there are compelling grounds for suggesting =
that
the PACE Trial should never have been granted approval or funding.=A0=20
The ME Association has been adamant that the PACE and FINE trials should =
be
halted and on 22nd May 2004 posted the following on its website (which =
was
printed in its magazine "ME Essential" in July 2004):
"The MEA calls for an immediate stop to the PACE and FINE trials
"A number of criticisms concerning the overall value of the PACE trial =
and
the way in which it is going to be carried out have been made by the =
ME/CFS
community. The ME Association believes that many of these criticisms are
valid. We believe that the money being allocated to the PACE trial is a
scandalous way of prioritising the very limited research funding that =
the
MRC have decided to make available for ME/CFS, especially when no money
whatsoever has so far been awarded for research into the underlying =
physical
cause of the illness.=A0 We therefore believe that work on this trial =
should
be brought to an immediate close and that the money should be held in
reserve for research that is likely to be of real benefit to people with
ME/CFS. We share the concerns being expressed relating to informed =
consent,
particularly in relation to patients who are selected to take part in =
graded
exercise therapy. The Chief Medical Officer's Report (section 4.4.2.1) =
noted
that 50% of ME/CFS patients reported that graded exercise therapy had =
made
their condition worse, and we therefore believe that anyone volunteering =
to
undertake graded exercise therapy must be made aware of these findings".
The ME Association notice additionally called for all further work on =
the
FINE trial to be halted, saying the MEA "is not convinced by the =
evidence so
far put forward in support of this approach".
It is recorded in documents obtained under the Freedom of Information =
Act
that the Principal Investigators and the various Ethics Committees were
fully aware of the strength of the opposition to the PACE Trial but that
these were dismissed by Professors Sharpe and White: Minutes of the =
Joint
Trial Steering Committee and Data Monitoring and Ethics Committee =
meeting
held on 27th September 2004 record that Professor Paul Dieppe (Chair of =
the
Data Monitoring and Ethics Committee) expressed: "anxiety that =
recruitment
might be impeded by the anti-PACE/FINE lobbyists.=A0 Professor Sharpe =
and
Professor White stated that lobby groups had not previously affected
recruitment in trials of GET, which is the most controversial of the
therapies to be tested".
A further example is to be found in the Report of the PACE Trial
statistician Dr Tony Johnson (a member of the Trial Management Group, a
member of the Trial Steering Committee and the person who will oversee =
the
Clinical Trial Unit that is directed by Professor Wessely) who confirmed =
in
the MRC's Biostatistical Unit's Quinquennial Report for 2002 - 2006 that =
the
MRC was funding the PACE and FINE Trial "despite active campaigns to =
halt
them".=A0 A notable point is that his Report was co-authored by =
Professors
Peter White, Trudie Chalder and Michael Sharpe, so all of them were =
aware of
the strength of opposition to the PACE Trial.
It is also a matter of record that Principal Investigator Professor =
Michael
Sharpe confirmed: "The MRC is currently funding the PACE =
trial=85.However, the
trial has faced serious antagonism from some, but not all, patient =
groups,
mainly because of concerns about the use of 'psychological treatment' =
for a
condition that is seen by many as a medical disorder"=A0 (Report on MRC
Neuroethics Workshop, 6th January 2005: Section 2: Altering the brain).
It is certainly the case that even the MRC's own Neuroethics Committee
expressed doubts over the use of CBT: "=85CBT aims to influence how a =
person
thinks or behaves=85Although psychotherapies are usually thought of as
psychological therapies, there is increasing evidence that they can =
alter
brain function.=A0 Further research is needed to =85determine whether =
therapies
are reversible or if there are persistent adverse effects.=A0 There is =
already
evidence that in certain situations psychotherapy can do harm=85There is =
also
increasing public concern that psychological therapies could be used for
brainwashing=85.How much information should patients be given about the
possible effects of therapy on their brain?=85.CBT techniques are now =
being
used more widely to treat somatic conditions=85How appropriate is this =
use of
psychological therapy?
In an article in the New York Times that was published before the PACE =
Trial
began (27th August 2002: "Behaviour: Like Drugs, Talk Therapy Can Change
Brain Chemistry"), Richard Friedman MD -- a psychiatrist who directs the
Psychopharmacology Clinic at the New York Weill Cornell Medical Centre -
stated "Psychotherapy alone has been largely ineffective for diseases =
where
there is strong evidence of structural, as well as functional, brain
abnormalities.=A0 It seems that if the brain is severely disordered, =
then talk
therapy cannot alter it".
As there are structural brain abnormalities documented in the ME/CFS
literature since at least 1992, one of which being the significant loss =
of
grey matter in the brain with irreversible loss of grey cells, =
especially in
Brodmann's area 9, (which may indicate major trauma to the brain), then =
the
chance of cognitive behavioural therapy being effective in ME/CFS is
probably zero.=20
Indeed, it was reported by Professor Leonard Jason at the Reno =
Conference
(March 2009) that one group of patients did not benefit from cognitive
behavioural interventions: this was the subset whose laboratory
investigations showed they had increased immune dysfunction and low =
cortisol
levels.
As the data discussed by Friedman was known about in 2002 (the same year
that the UK CMO's Working Group Report was published), then it must be =
asked
why this knowledge has been disregarded by the Wessely School =
psychiatric
lobby.
Given what is already known about the inherent dangers of CBT/GET for =
those
with ME/CFS (especially the known effects of graded exercise as an =
inducer
of oxidative stress and the effects of incremental aerobic exercise on =
the
cardiovascular problems known from the early part of the twentieth =
century
to be an integral feature of authentic ME/CFS), on what ethical grounds =
can
those already crushed by such a heavy illness burden as that imposed by
ME/CFS be subjected --- despite denials, in some cases by apparent =
deceit
and coercion - to a management regime that seems to have no hope of
beneficial results?
This raises once again the disturbing question: in whose best interests =
is
the MRC PACE Trial being undertaken?
At the MRC Workshop on CFS/ME held on 19th / 20th November 2009 at =
Heythrop
Park, Oxfordshire, in his introduction Professor Stephen Holgate =
effectively
said that the reason for the meeting was the need to move forward, to =
get
away from old models and to use proper science, and that there was no =
reason
not to change things, a view he had also expressed at the RSM meeting
"Medicine and me" on 11th July 2009.=20
The question is -- will the results of the MRC PACE Trial and the vested
interests of the Wessely School ever permit the getting away from "old
models"?
The science is there, the evidence is there, but the political will =
still
seems not to be there, and until the Government can no longer credibly
refuse to permit such change, Holgate's hopes are unlikely to =
materialise in
the UK.
_________________________________
Download the .pdf here=85
http://www.meactionuk.org.uk/Can-the-MRC-PACE-Trial-be-justified.pdf
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