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It is well known
within parts of the ME community that public funding for biomedical
research into Myalgic Encephalomyelitis is non-existent. Despite
many applications for such funding to the
Medical Research Council (MRC) over recent years all
have been rejected.
Therefore, it is
of interest that the body responsible for allocating funds to
research into ME – the MRC – see fit to allocate funding to these
trials.
The MRC state
that funding is not ring-fenced for ME and that, if these trials did
not go ahead, then the funding would not necessarily go elsewhere.
We received an email from Alice Burchfield relating to
her experiences from participation in the FINE trials. The email is quite
illustrative of the contents and effects/results of the FINE trials.
After reading Alice's story it might
be worth looking at the background to these trials and then reflecting on
Alice's experiences.
After that one may well wish to
visit the ME and My MP campaign pages to enquire from one's MP as to why we have
money to spend on these trials but the amount spent on biomedical research into
a biological illness (ME) is, at the current point in time, £0.00.
Experiences
of the FINE Trials
Click here to
read Alice's email. Then, whilst the popup window is there, read the
background to FINE.
FINE Trials -
Set Up and Objectives
These trials are
funded by the Medical Research Council (MRC) alongside another set
of trials called PACE trials. Both are described by the MRC[1] as
‘..complementary
trials into various treatments options for CFS/ME which aim to
improve quality of life for those who are ill.'
‘FINE (Fatigue
Intervention by Nurses Evaluation) will test two different
treatments that are particularly suited to those who are too ill to
attend a specialist clinic.'
'The FINE trial
will involve patients in the North West of England and North Wales.'
The recruitment of patients for
both trials was started in 2004 and, according to the MRC, were
expected to take up to five years to complete.
The FINE trials
are headed by Dr. A. Wearden from Manchester University whose
background is rehabilitative therapy.
FINE treatments
would be delivered in patients’ own homes (‘so the trial is
particularly suited to those who are too ill to attend specialist
clinics.’ – according to the MRC)
The therapy
involves four 90 minute sessions interspersed with six 30 phone
conversations over a period of 18 weeks with the addition of an
activity manual.
The MRC claim
the FINE trials will perform/compare the following –
·
Usual medical care
·
Supportive listening
delivered by a
trained nurse
·
Pragmatic rehabilitation
The MRC further state -
·
Pragmatic rehabilitation was developed by the research team, and is
based on an approach that proved popular with patients who took part
in a
previous study.
The treatment manual for this trial has been developed in
association with those patients.
·
The approach combines helping patients to understand their symptoms
and jointly agreeing a programme of rehabilitation.
·
The trial will also evaluate whether the delivery of pragmatic
rehabilitation
can be easily taught to qualified nurses without the need for lengthy
and expensive training. If successful it could provide an invaluable addition to
the help on offer in a primary care setting.
·
The treatments in the trial will be delivered to the highest standard by
qualified nurses specially trained for the trial.
As
with all MRC trials FINE has been subject to extensive peer review
(assessment by independent international and UK experts), will be
conducted to the highest standard and will be subject to independent scrutiny
by a Trial Steering Committee and Data Monitoring and Ethics Committee.
IiME Questions on the above
-
What is
meant by trained nurse?
Trained in what?
-
Pragmatic rehabilitation
- Rehabilitation implies the application of remedies to effect a
cure. Does this then mean that FINE trials are aiming to cure ME
patients? Does this preselect a diagnosis of ME as a psychological illness?
-
Previous study - what previous study?
-
can be easily taught to qualified nurses
without the need for lengthy and expensive training- what qualifications are required to treat ME which do not
require expensive or lengthy training? Can anyone do this? Why
are there 250,000 ME sufferers then in the UK alone?
-
treatments - Treatments are discussed
here. How can a treatment be delivered if a proper diagnosis has
not been performed using standard clinical guidelines
-
to extensive peer review -
Who? When? Where?
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Inclusion Criteria
The
MRC claims that the trials will use the most inclusive criteria for CFS/ME to
determine eligibility to take part (the
Oxford criteria)
in order for the results to be generalised to the largest number of
people possible.
IiME Comment
The Oxford criteria are already known to be flawed for any
scientific basis for diagnosis. By including as many as possible
from a wide range of diagnosed patients the results will be
skewed. Is there any point to producing a generalised result set
for a set of expensive trials which are to be applied to an
organic illness?
What is
the reason that the MRC continue to use these outdated and
unscientific criteria?
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FINE
TRIAL COSTS
The FINE trials cost £1,147,000.
IIME
Position
The FINE trials and the PACE trials seem to be the
two ugly sisters of MRC policy on ME - leaving biomedical research
eternally to play a Cinderella role.
Their results are pre-judged due to the biased
criteria used for selection and the methods employed in performing
One thing these trials seem to be clearly showing is
the myopic and unscientific approach to scientific research being shown by the MRC in
concentrating on psychiatric paradigms which, at best, can only
attempt to cope with ME and, at worst, will seriously affect a person
with ME's
health.
The MRC state -
'The Oxford criteria will allow
researchers to generalise their findings to the largest possible
number of people with CFS/ME and ensure the trial can recruit enough
people to give meaningful results.'
A psychiatrist's dream scenario!
To quote ME Research UK (see link below) -
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'...one thing we
do know. The FINE trial is recorded under the "Mental Health in
Primary Care" programme in the National Research Register 2004.
And there's the rub. Given the expanding core of
evidence for a biological pathology for this illness, it is
widely felt by patients, support groups and their political
representatives that scarce research funding would be better
targeted at appropriate biomedical investigation and treatment
of the physical basis of ME.' |
A definitive set of diagnostic guidelines for
clinical diagnosis and research is available with the Canadian
guidelines (see Guidelines).
Using these would make the FINE trials obsolete (see also
Canadian Guidelines acceptance). It is one of the fundamental issues which needs to be resolved in order for
myalgic encephalomyelitis to be treated in the correct way.
Isn't it time to stop this waste of tax payers'
money and put it to better use?
Links to other sites on this topic
[1]
www.mrc.ac.uk/index/public-interest/public-topical_issues/public-cfs/public-cfs_trials.htm
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