Friday, December 14, 2012

PACE and the 27 Signatories

PACE and the 27 Signatories

Susanna Agardy

To The Independent

Re: Letter concerning Chronic Fatigue Syndrome/ME by Dr Esther Crawley et al, 2 December 2012

I refer to the above letter in defence of Prof. Wessely. Its contents
should be seen in the context of Prof. Wessely's central role in the PACE
trial and its promotion, and his recent media offensive against ME/CFS
patients. Patients are not trying to discourage specialist clinicians from
entering the field, particularly ones with appropriate qualifications. They
just don't want inappropriate treatment forced on them. The PACE study
warrants careful examination.

Regardless of how many psychiatrists and other medical professionals sign a
letter to newspapers, the fact remains that about 70% of participants in
PACE did not reach 'normal' results
, even by the convoluted definition of
'normal' in the study. The study does not report a single participant returning to their pre-illness lives (unless this information still awaits publication). Why would ME/CFS patients clamour for a treatment based on
such a study? Besides, they already know that their condition is not
amenable to the proposed treatment
by Cognitive Behaviour Therapy
(CBT) and Graded Exercise Therapy (GET).

Amid the celebration of some 'moderate' improvement in the 30% of
participants and the promotion of PACE as a treatment, the 70% have been
forgotten. (I use the term ME/CFS because at least 51% of participants
reportedly had post-exertional malaise, the major symptom of ME. This
indicates that the intended use of the Oxford Criteria failed because it
did not exclude conditions which do not form part of the definition.)

In the discussions about PACE we do not hear much about the results of the
6 minute walking test, the only objective measure of physical ability in
this trial. The best average results for this test were 379 metres for the
GET group, up by 67 metres and 354 metres for CBT, up by 21 metres. By
definition, some patients would have produced worse results. At the start
of the trial these participants were assumed to be merely deconditioned due
to fear and activity avoidance. They had an average age of 38 years and
received encouragement and training for one year at the average cost of
about £7,800 per head. While those in the GET and CBT conditions fared
better compared with the other study conditions, the big picture is that
they achieved a poor training effect which is well surpassed by patients
with diseases recognised as serious.

The PACE patients' walking distance was less than 400 metres, worse than that of patients awaiting organ transplantation. In a study of patients
with pulmonary disorder (including those needing supplemental oxygen) the 6
minute walking distance was, on average, 60 metres more than that achieved
by participants in the GET treatment in the PACE trial. A distance of 518
metres has been considered abnormally low for healthy elderly people
Moreover, there is no report of any assessment of the possibly delayed after-effect
of the walking test in PACE, a most important measurement of ability in
people with ME. How is it that the poor results have been overlooked by
all the medical professionals defending the PACE trial?

Aren't the signatories and other defenders of PACE curious to know why
there was not greater improvement found in the trial? Don't they want to
know what factors held back the performance of these participants?

The hypothesis of PACE was that patients become deconditioned due to fear
and unhelpful cognitions. The consequent exercise avoidance leads
to physiological changes. This theory incorporates several assumptions.
Firstly, it is assumed that ME/CFS patients harbour a fear of activity
which is irrational. This is merely a preferred interpretation which is an
alternative to accepting that patients are responding in a responsible way
to their physiological needs. They know from experience the symptoms
instigated by what is for them excessive activity.
Secondly, there is an
assumption of a causal connection between any such hypothesized fear and
lowered activity and the resulting unspecified 'physiological changes'
which are assumed to occur through some unspecified mechanism. The
physiological changes are also assumed to follow, rather than precede, due
to some other cause, the stated psychological reaction. Thirdly, it is
assumed that there is no organic problem worth worrying about, nothing that
some CBT/GET can't fix. There is a significant body of biomedical evidence
to contradict this, showing numerous physical abnormalities in ME/CFS.
evidence is never acknowledged by the supporters of PACE.

As if this number of untested assumptions weren't enough it is then assumed
in the PACE trial that these changes are reversible. There is no evidence
in the report that any participant's condition was reversed.

Either the diagnosis of fear avoidance and deconditioning etc. is wrong, or
the treatment is inappropriate.
The authors only contemplate the latter
possibility. They stop short of contemplating the possibility that the
diagnosis is wrong at least for some sections of the sample and that their
model has failed for them at least. They say: 'The effectiveness of
behavioural treatments does not imply that the condition is psychological
in nature.' What is it then?

It is staring us in the face but remains unsaid by the investigators that
ME/CFS might indeed have a strong biological basis which prevents better
performance in the tests used here and that the 'physiological changes'
attributed to deconditioning/fear avoidance, etc. ought to be explored by
appropriate laboratory investigations.

Here is a suggestion: the worst-performing group in the 6 minute walking
test of the PACE study should be invited to participate in a biomedical
study investigating physiological factors which might be at work in their
poor performance. They could be compared with the best-performing group as
well as with healthy controls. Biomedical research into ME/CFS has already
discovered physiological processes relevant to physical and mental
performance. These findings are never mentioned by the authors.
This could
be an elegant follow-up project.

Yes, this would mean turning to the biomedical model for assistance, so far
not countenanced by the authors. It would also mean turning away from the
biopsychosocial model as it is currently applied, with the dominance of the
'psychosocial'. But, evidence has failed to support the paradigm favoured
by the authors. In accordance with good scientific principles it would be
appropriate to discard this paradigm and try another, the biomedical one,
which shows promise. Why cling stridently to the wreckage of a failed
paradigm? This shift could also be seen as a rebalancing of the
biopsychosocial paradigm by restoring the 'bio' to it. The psychosocial
needs of patients can still be cared for in accordance with the ideals of
the model.

Susanna Agardy


dolly daydream said...

Excellant article. Wish my ignorant doc would take this on board. He suggested I played wheelchair rugby to get some excercise last time I saw him.

CFS Facts said...

We've all had such ignorant doctors. I put one of mine on the spot, were there any medical conditions where exercise is bad. He came up with one, then quickly added "but you don't have that." Never said I did -- just needed him to think outside the box for a minute, to understand that it's not "impossible" for exercise to make you sicker.

All my problems that have been described as "medically impossible" are, in fact, to be expected in some other rare conditions. Just got to get the doctors to admit that, rare as it may be, it IS possible.