Sunday, April 10, 2011

Dr. Jason's presentation at SoK Conference

Extracts from Professor Leonard Jason's Presentation at the NIH State
of the Knowledge Workshop on ME/CFS

Bethesda, Maryland,  7th-8th April 2011


Margaret Williams                       9th April 2011


At the National Institutes of Health "State of the Knowledge" (SOK)
Workshop on ME/CFS held in Bethesda, Maryland on 7th-8th April 2011,
Professor Leonard Jason from DePaul University, Chicago, gave a
hard-hitting presentation, repeatedly emphasising the absolute
necessity for researchers to be looking at the same disorder.

He specifically mentioned the UK PACE Trial (carried out by Wessely
School psychiatrists) and noted the controversy flowing from that
trial.

The PACE Trial Principal Investigators (PIs) intentionally sought as
heterogeneous a cohort of "fatigued" people as possible in order to
enhance both recruitment to the trial and the alleged
"generalisability" of the Wessely School's cognitive re-structuring
and aerobic exercise programme to as many "fatigued" people as
possible (Trial Identifier:3.6).

Such intentional heterogeneity obviously captured people with
affective disorders in which "fatigue" is a prominent feature, yet the
PIs assert that they were studying patients with "CFS/ME" (which they
insist is the same disorder as ME/CFS, a complex neuroimmune disorder)
when their definition of "CFS/ME" has few of the features of classic
ME/CFS. Indeed, the pathognomonic feature of ME/CFS  --
post-exertional fatigability with malaise -- is not required in their
definition of "CFS/ME" which has on-going "fatigue" as the primary
symptom.

This deliberate conflating of different disorders by the Wessely
School has caused dismay amongst international scientists studying
classic ME/CFS, who at the SOK Workshop emphasised the
near-impossibility of validating the existing biomarkers when such
divergent cohorts of subjects are used (for example, by psychiatrists
with fixed beliefs about the nature of "CFS/ME" who continue to
disregard the biomedical evidence and the key diagnostic criteria
contained in the 2003 Canadian Guidelines).

Despite the fact that the UK Department of Health accepts ME/CFS as a
neurological disorder of unknown origin, in its recent submission to
the NICE "consultation" process regarding any necessity to update the
NICE Clinical Guideline 53 on "CFS/ME" that recommends only CBT/GET
for people with "CFS/ME", The Royal College of Paediatrics and Child
Health referred to the disorder as: "a psychological illness with
physical manifestations" (http://bit.ly.gpdove) and on the Great
Ormond Street (childrens) Hospital website, "CFS" is categorised as a
somatic problem: it is placed in "Department of Child and Adolescent
Mental Health" section and then under "Feeding & Eating Disorders
Service" is to be found the following: "emotional eating difficulties
(e.g. food phobias) or in the context of somatic problems such as
chronic fatigue syndrome"
(http://www.gosh.nhs.uk/website/gosh/clinicalservices/DCAMH/Homepage?forumid=331851  ).

In the UK, NHS staff are likely to obtain their knowledge about the
PACE Trial from the "NHS Choices" Information page on its website
(http://www.nhs.uk/news/2011/02February/Pages/therapies-moderately-improve-CFS.aspx ).

Perhaps unsurprisingly, this website contains frank misinformation
about the results of the PACE Trial; for example, the PACE Trial was
not a "controlled" trial as claimed; the Oxford criteria are not
"standard diagnostic criteria for CFS" when "CFS" is deemed to include
ME -- they are used only by the Wessely School who produced them in
1991; PACE participants were not "confirmed as free of mental health
problems such as depression and anxiety"
; participants did not meet
the (proposed) "London Criteria" for myalgic encephlaomyleitis, but a
version compiled by the Chief PI (Professor Peter White) himself,
which was basically the Oxford criteria without psychiatric illness;
SMC (specialist medical care) was not universally provided by a doctor
"with specialist experience in CFS"; 22 of these "experienced
specialists" were in fact trainees (all from the same centre) who, by
virtue of being trainees, could not be called experts experienced in
the medical care of people with CFS.

Thus despite hollow assurances from the Department of Health, the
grass roots situation in the UK remains dire for people with ME/CFS,
so the following quotations from Professor Jason at the SOK Workshop
are of particular relevance to patients themselves and to the various
agencies of State to which the Wessely School are advisors on
"CFS/ME":

"If investigators select samples of patients who are different in
fundamental aspects of this illness because of ambiguities with the
case definition, then it would be exceedingly difficult for
investigators to consistently identify biomarkers".

"In summary, any scientific enterprise depends on reliable and valid
ways of classifying patients into diagnostic categories.  When
diagnostic categories lack reliability and accuracy, the quality of
the treatment and clinical research can be significantly compromised".

"If CFS is to be diagnosed reliably across health care professionals,
it is imperative to deal with criterion variance issues and provide
specific thresholds in scoring rules for the selected symptomatic
criteria".

In the discussion that followed his presentation Jason was emphatic:

"Those folks who have primarily affective disorder need to be differentiated".

"I think the key issue is the defining of the sample and in our
current scientific publications, the basic description of who these
samples are is completely inadequate, and we've got to do something to
change that….if we don't tackle that issue…our foundation is just
going to be shaky".

During this discussion, Professor Nancy Klimas commented cogently:
"Here we are, quite some 20 years into this, still talking about the
bloomin' case definition"; she registered her frustration and pointed
out that lack of a unified case definition prevents the existing
biomarkers for neuroimmune disorders being utilised.

Professor Jason responded:

"There needs to be a decision as to which are the symptoms and which
are the tests that we want to use (so that) everybody uses those
particular symptoms and asks questions the same way – standardised
questionnaires, and if we can get that accomplished by everybody being
on the same page with that, I think we would do enormous benefit for
our field".

"What I'm really suggesting, because a lot of what we're talking about
here is biological markers, is that ultimately, if we have samples
that are different in different labs and have different
characteristics, it's going to be very difficult for us to get the
types of consistency of the biological markers…The problem we're all
faced with is that when we don't get common findings across labs, it's
very easy for the media – and others – to look at those results and
not understand the complexities that we're faced with and (they) say –
oh, you don't find the same abnormalities, you don't find the same lab
findings, it's not like HIV (where) you find it everywhere….
ultimately you end up (with it) being thought of as a psychogenic
illness, and that's the problem.  It's the consequence of
…attributions being made that I think are not correct".

At this point, the Editor of the journal "Brain, Behaviour and
Immunity" asked a question and then agreed to publish such
standardised criteria in his journal, an undertaking that was
well-received.

Professor Jason ended the discussion by referring to the UK PACE Trial:

"There's tremendous confusion about who's in particular samples.
Those of you who have been reading about the PACE trial….one of the
big issues was, was it the Oxford criteria, was it the Fukuda
criteria, or the international, or the Reeves empiric case definition,
and I think a lot of controversy came out of that trial in part
because people were trying to figure out who were their patients, and
I know that they did some subgroup analyses in that study, but I think
it's absolutely critical for this diagnostic issue to be tackled
head-on".

Will the Wessely School psychiatrists pay any attention to this
critical issue of diagnostic criteria for ME/CFS or will they persist
in ignoring the international scientific research community and
implacably insist that "CFS/ME" is a somatoform disorder that is
reversible, if not curable, by their own brand of directive
psychotherapy as they have done for the last 25 years, to the serious
detriment of both patients and progress in medical science?

Permission to repost.

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