Summary of High Court Proceedings - Judicial Review of NICE Guidelines

http://www.meassociation.org.uk/content/view/791/161/


MAY BE REPOSTED



Judicial Review
summary of High Court proceedings



The Judicial Review of the NICE guideline on
ME/CFS took place on Wednesday and Thursday,
11th and 12th February, at the Royal Courts of
Justice in London.  The hearing was held in Court
76 - a large modernised courtroom tucked away
on the third floor of this historic maze of legal
activity.


Unlike the preliminary hearing in June last year,
there was plenty of room to move around along with
comfortable non-squeaking seats and wheelchair
access - although it was difficult at times for those
at the back to hear precisely what was being said by
barristers representing the two sides.

Around 50 members of the public, along with
occasional brief visits from journalists, packed Court
76 to witness the proceedings.  At times, a 'Court
Full' sign had to be posted up.  Not surprisingly,
there did not appear to be a single person with
ME/CFS who had come up to London to support the
NICE guideline.

Outside the main entrance in The Strand, where all
the TV news bulletin shots of the High Court are
taken, a small peaceful demonstration against the
NICE guideline took place over lunch.  This managed
to attract quite a lot of legal and public interest.

Almost all of Wednesday was taken up with a legal
presentation from barrister Jeremy Hyam on behalf of
the two claimants who suffer from ME - Kevin Short
from Norfolk and Douglas Fraser from London.

In relation to the effects of the NICE guideline on
practical patient care, two key issues were
examined:

Firstly, the procedures by which the NICE guideline
development group (GDG) had come to the
conclusion that the only treatments worth
recommending for people with ME/CFS were two
behavioural interventions, namely cognitive
behaviour therapy (CBT) and graded exercise therapy
(GET), and this was to the exclusion of all others.

Secondly, the fact that a number of medical/drug and
supplement interventions, which may be helpful in
selected cases, were not therefore being
recommended by NICE.  As a result of not being
recommended, doctors would not be willing to
consider using them, and healthcare providers (ie
PCTs) would not be willing to pay for them.  Some
people with ME/CFS would therefore be denied forms
of treatment that could be of benefit.


In relation to the way in which a judicial review is
there to examine procedures rather than actual
decisions, it was argued that the decision making
process had been based on a foundation of
insufficient evidence of clear benefit being available
to recommend the widespread use of CBT and GET.

In particular, was the way in which a systematic
review of results from randomised controlled trials
involving CBT and GET (ie the York Review) had
failed to demonstrate the sort of robust  consistent
evidence that could stand alone and satisfy the
requirements for this type of recommendation to be
made in a NICE guideline.

Counsel for the claimants also argued that
insufficient weight had then been given to certain
other key sources of evidence further down the
hierarchy of evidence that were made available to
the guideline development group - in particular the
results of patient questionnaires and stakeholder
feedback which had reported that in a significant
proportion of people with ME/CFS these treatments
were either ineffective or even harmful.

When it came to the final analysis it was argued that
with several members of the GDG being involved in
clinical trails involving these two treatments, or
expressing support for their use, there was an
appearance of bias in the way that the GDG decided
to recommend CBT and GET as the only forms of
effective treatment.

To support the appearance of bias reference was
made to comments contained in a letter from a
patient representative on the GDG (Tanya Harrison)
who had resigned from the group as a result of what
she believed was bias towards the psychosocial
model. It was also argued that the appearance of
bias towards CBT and GET was compounded by the
absence of any health professionals on the GDG who
were known to be in favour of the biomedical model
of ME/CFS


The final part of the first day's hearing, and almost
all of Thursday morning, was taken up by counter
arguments being presented by the barrister
representing NICE, namely that the research
evidence in favour of CBT and GET was sufficiently
robust; that the process of collecting and analysing
other types of evidence from clinical trials,
stakeholders, experience of clinicians etc was
thorough and transparent; and that no evidence of
bias towards the psychosocial model had been shown
by individual members of the GDG.

Neither was there any bias in the way in which the
members of the GDG  were selected by nomination of
the relevant Royal Colleges or professional bodies,
and some of the accusations relating to bias, conflict
of interest, or disclosure of interest were based on
factual inaccuracies.

In other words, the procedures that were followed by
NICE were as robust and fair as could be achieved in
the circumstances and that the decision to only
recommend CBT and GET was not the result of any
bias on the part of individual members of the GDG,
or the group as a whole.  Legal arguments on behalf
of the defendants (ie NICE) went on till early
afternoon on Thursday.


Thursday afternoon produced a further legal
argument involving the cost effectiveness of both
treatments.  This was given by a barrister acting for
an 'interested party' in the case against NICE.
Evidence was put forward on behalf of this interested
party to show that the cost effective analysis for CBT
was seriously flawed and that no proper cost
effectiveness analysis for GET had even been
undertaken.  In other words, it was claimed that
NICE was recommending two forms of treatment that
had not yet been properly shown to be cost
effective.  Again, this position was vigorously
challenged by the barrister representing NICE.

A great deal of time was spent in discussing the
points that are summarised above, along with legal
technicalities.  However, some of the  other aspects
of the case against the NICE guideline, which have
surfaced in public discussion on the internet prior to
the case being heard in Court, were not referred to or
left very much out on the periphery (eg neurological
classification of the illness).

Legal arguments and discussion went on till almost
5pm on Thursday and there is still some unfinished
business for the Judge, Mr Justice Simon,  to deal
with.  So it looks as though the Judge's decision on
the case will be delayed for at least a week, possibly
even longer.


     * The ME Association has fully supported the case
for Judicial Review that has been made by the two
claimants - see here:
http://www.meassociation.org.uk/content/view/781/161/

     * A summary of press reports on the Judicial
Review can be found here:
http://www.meassociation.org.uk/content/view/789/161/


     * For anyone involved with insurance companies
referred to during the hearing - Exeter Friendly
Society and Liverpool Victoria - some interesting and
useful statements regarding their positions on
recognition and classification of ME/CFS were made
during the hearing.





Summary prepared by Dr Charles Shepherd

14 February 2009

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Open Letter to CDC's Bill Reeves

Dear Sir:

I am a long-standing ME patient from south Africa. I have been
following your research for a number of years but recently your
activities have begun to concern me.

Your empirical definition is too broad and includes too many
psychiatrically Ill patients. Furthermore, your collaboration with
several unpopular British psychiatrists Is worrying.

Recently your work has focused on vague notions of fatiguing illness
and, once again, your collaboration with Emory psychiatric
researchers is of grave concern to ME/CFS patients.
You are letting down a desperately ill and marginalised patient community.

Please either get your house in order or quit your position so that a
suitable alternative candidate can take up the challenge of
researching this difficult illness, who does not collaborate with
mental health researchers, some of who's views on the treatment of
ME/CFS are deeply unpopular with ME patients, who hasn't designed a
deeply flawed empirical definition of ME/CFS and who will not waste
resources on studying vague notions of fatiguing illnesses.

Sincerely,

Jeremy Bearman
BSoc Sc PDM MBA

P.S. Co-cure forced me to censor this article because it contained
disparaging references to Wessely school psychiatrists

 

 

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MS vs. ME (CFS)

*please repost* *please repost* *please repost* *please repost*

M.E. vs MS: Similarities and differences, by Jodi Bassett February 2009

One of my most vivid memories of early childhood is of the day that a woman
with Multiple Sclerosis (MS) came to my primary school to give a talk to my
class. She spoke to my 9 year old classmates and me about MS and encouraged
us to help to raise funds for research into MS with the MS-read-a -thon. She
was somewhere between 30 and 35 at the time I think, perhaps a bit younger.


I don't recall if the woman with MS was in a wheelchair or just sitting, but
I remember how well she spoke. She was such a confident and engaging
speaker. She held our full attention for the entire time she spoke. I felt
that she knew what she was doing was important, and was proud to be able to
do it. I thought she was so brave and so strong and inspiring.


I remember that she told us that her first indication that something was
wrong with her was the day that she ended up with burns on her back because
she could no longer correctly feel the water temperature. She described this
burning so vividly. I felt so sorry for her, and for everyone with MS. It
seemed like an unbelievably terrible thing to happen to someone. Just
unimaginably awful, like your worst nightmare. I wished so much that people
with MS didn't have to go through such horrible experiences.


The talk on MS made a real impact on me at the time and stayed with me for a
long time afterward. For years I read as many books as I could during the
annual MS-read-a-thon.  I spent a lot of time thinking about the woman with
MS I'd met and I wondered how she was. I felt so sorry for her.


I could never have imagined back then that a mere 10 years later I'd be in
the terrible position of ENVYING this same woman with MS.


My story

What happened was that when I was 19 I suddenly became ill with Myalgic
Encephalomyelitis (M.E.). I was a normal, active and happy 19 year old when
suddenly everything changed.  I experienced severe brain damage from one
moment to the next. The first I knew of my illness was when my brain, my
heart, my balance and just my whole body just stopped working like they used
to and started doing all sorts of strange and terrible things. I couldn't
think anymore and I couldn't do anything anymore like I'd used to. I had
literally dozens of extreme and ever-changing symptoms and disabilities that
became so much worse whenever I did anything at all.


Unfortunately my illness worsened steadily over the next decade or so. 14
years later I'm completely housebound and about 99% bedbound. I'm very
disabled in many different ways, physically and cognitively.


Medical similarities between MS and M.E.

The reason I'm envious is not so much because of the type of illness MS is
medically compared to M.E. M.E. and MS are actually very similar medically
in many ways, as the following list demonstrates.



Table 1. Medical similarities between MS and M.E.*


MS is primarily a neurological disease, i.e. a disease of the central
nervous system (CNS).

            M.E. is primarily a neurological disease, i.e. a disease of the
central nervous system (CNS).



Demyelination (damage to the myelin sheath surrounding nerves) has been
documented in MS.

            Demyelination (damage to the myelin sheath surrounding nerves)
has been documented in M.E.



Evidence of oligoclonal bands in the cerebrospinal fluid has been documented
in MS.

            Evidence of oligoclonal bands in the cerebrospinal fluid has
been documented in M.E.



No single definitive laboratory test is yet available for MS but a series of
tests are available which can objectively confirm the diagnosis with some
certainty.

            No single definitive laboratory test is yet available for M.E.
but a series of tests are available which can objectively confirm the
diagnosis with a high degree of certainty.



MS can be severely disabling and cause significant numbers of patients to be
bedbound or wheelchair-reliant.

            M.E. can be severely disabling and cause significant numbers of
patients to be bedbound, wheelchair-reliant or housebound.



MS can be fatal (either from the disease itself or from complications
arising from the disease)

            M.E. can be fatal (either from the disease itself or from
complications arising from the disease)



MS significantly reduces life expectancy.

            M.E. significantly reduces life expectancy. (M.E. reduces life
expectancy by a greater period than MS: see Table 3.)



Symptoms/problems which occur in MS include: impaired vision, nystagmus,
afferent pupillary defect, loss of balance and muscle coordination, cogwheel
movement of the legs, slurred speech, difficulty speaking (scanning speech
and slow hesitant speech), difficulty writing, difficulty swallowing,
proprioceptive dysfunction, abnormal sensations (numbness, pins and
needles), shortness of breath, headaches, itching, rashes, hair loss,
seizures, tremors, muscular twitching or fasciculation, abnormal gait,
stiffness, subnormal temperature, sensitivities to common chemicals,
sleeping disorders, facial pallor, bladder and bowel problems, difficulty
walking, pain, tachycardia, stroke-like episodes, food intolerances and
alcohol intolerance, and partial or complete paralysis.

            Symptoms/problems which occur in M.E. include: impaired vision,
nystagmus, afferent pupillary defect, loss of balance and muscle
coordination, cogwheel movement of the legs, slurred speech, difficulty
speaking (scanning speech and slow hesitant speech), difficulty writing,
difficulty swallowing, proprioceptive dysfunction, abnormal sensations
(numbness, pins and needles), shortness of breath, headaches, itching,
rashes, hair loss, seizures, tremors, muscular twitching or fasciculation,
abnormal gait, stiffness, subnormal temperature, sensitivities to common
chemicals, sleeping disorders, facial pallor, bladder and bowel problems,
difficulty walking, pain, tachycardia, stroke-like episodes, food
intolerances and alcohol intolerance, and partial or complete paralysis.



MS can cause orthostatic intolerance (dizziness or faintness on standing).

            M.E. commonly causes severe orthostatic intolerance (which often
worsens to become severe POTS and/or NMH).



Short-term memory loss, word finding difficulty, difficulty with
concentration and reasoning and other forms of cognitive impairment occur in
50% of MS patients. 10% of MS patients have cognitive impairments severe
enough to significantly affect daily life.

            Short-term memory loss, word finding difficulty, difficulty with
concentration and reasoning and other forms of cognitive impairment occur in
100% of M.E. patients. Almost all M.E. patients have cognitive impairments
severe enough to significantly affect daily life.



MS patients often become severely more ill in even mildly warm weather. Cold
weather can also cause significant problems.

            M.E. patients often become severely more ill in even mildly warm
weather. Cold weather can also cause significant problems.



MS can affect autonomic nervous system function (including involuntary
functions such as digestion and heart rhythms).

            M.E. can affect autonomic nervous system function (including
involuntary functions such as digestion and heart rhythms).



MS is thought to cause a breakdown of the blood brain barrier.

            M.E. is thought to cause a breakdown of the blood brain barrier.



A positive Babinski's reflex is consistent with several neurological
conditions, including MS. (Babinski's reflex or extensor plantar reflex is a
test for dysfunction of the corticospinal tract.)

            A positive Babinski's reflex (or extensor plantar reflex) is
consistent with M.E.



The Romberg test will often be abnormal in MS. (This test measures
neurological or inner ear dysfunction.)
              The Romberg test will be abnormal in 95% or more of M.E.
patients.



An abnormal neurological exam is usual in MS. Abnormalities are also
commonly seen in neuropsychological testing in MS.

            An abnormal neurological exam is usual in M.E. Abnormalities are
also commonly seen in neuropsychological testing in M.E.



MS causes a certain type of brain lesion detectable in MRI brain scans.
Abnormalities are also seen in EEG and QEEG brain maps and SPECT brain scans
in MS.

            M.E. causes a certain type of brain lesion detectable in MRI
brain scans. Abnormalities are also seen in EEG and QEEG brain maps and
SPECT brain scans in M.E.



Hypothyroidism is found in many MS patients.

            Hypothyroidism is found in almost all M.E. patients.



The glucose tolerance test is often abnormal in MS.

            The glucose tolerance test is often abnormal in M.E.



Low blood pressure readings (usually low-normal) are common in MS.

            Low blood pressure readings are extremely common in M.E.
Severely low blood pressure readings as low as, or lower than, 84/48 (or
75/35 according to many anecdotal accounts) are common in severe M.E. or
those having severe relapses. This can occur at rest or as a result of
orthostatic or physical overexertion. At times BP readings can be so low
that they cannot be measured by the machine and error messages appear.
Circulating blood volume measurements of only 50% to 75% of expected are
also commonly seen in M.E.



Patients with MS have an increased risk of dying from heart disease or
vascular diseases.

            Deaths from cardiac problems are one of the most common causes
of death in M.E.



Although MS is primarily neurological, it also has aspects of autoimmune
disease.

            Although M.E. is primarily neurological, it also has aspects of
autoimmune disease.



MS usually affects people between the ages of 20 and 40 years, and the
average age of onset is approximately 34 years. Onset occurs between the
ages of 20 to 40 years in 70% of patients.

            The average ages affected by M.E. are similar to those seen in
MS. However, the average age of onset may be significantly younger in M.E.



MS was once thought to be rare in children, but we know that around 5% of MS
sufferers are under 18.

            Around 10% of M.E. sufferers are under 18.



MS affects more than a million adults and children worldwide.

            M.E. affects more than a million adults and children worldwide.
(M.E. is at least as common as MS, and may be up to twice or three-times as
common.)

--


As well as there being many similarities in symptoms, the brain scans from
M.E. and MS patients are often very similar, as this chart illustrates. MS
and M.E. both cause a certain type of brain lesion detectable in brain
scans. Those with MS tend to have fewer brain lesions of a larger size,
while M.E. is associated with a greater number of these lesions of a
somewhat smaller size.


M.E. and MS are so similar medically that they are sometimes misdiagnosed as
one another.


The names used for M.E. and MS also indicate the similarities between the
two diseases. MS was first described in 1868, and MS has also been known as
'disseminated sclerosis' or 'encephalomyelitis disseminate.' Myalgic
Encephalomyelitis has existed for centuries but was first comprehensively
scientifically documented in 1934, when an outbreak of what at first seemed
to be poliomyelitis  (polio) occurred in Los Angeles (M.E. occurs in
outbreaks as well as sporadically). The term Myalgic Encephalomyelitis was
coined in 1956. Earlier names for M.E. include 'atypical polio' and atypical
multiple sclerosis.'


Both MS and M.E. have been correctly classified as organic diseases of the
central nervous system in the World Health Organization's International
Classification of Diseases for many decades. MS is classified at G 35 and
M.E. at G 93.3.


Why are people with M.E. often envious of people with MS?

MS and M.E. are distinct diseases, but they are in many ways very similar
medically. However, despite the medical similarities, the two diseases are
treated very differently politically and socially. The differences between
the political and social treatment of MS and M.E. are the reason for my envy
of MS sufferers......

--------

To read on please see:

http://www.ahummingbirdsguide.com/mevsms.htm

This page also includes a relevant quotes section, featuring comments from
other M.E. patinets about the similarities and differences between M.E. and
MS.

Permission is given for this unedited document to be freely redistributed,
**please redistribute this text widely**

Please link to the site version of  this text only as only this version will
be updated.

*Note: The table has been converted to plain text for the purposes of
redistribution here by plain text email. See the webpage or Word/PDF version
to see a more clearly formatted version of the chart!


Best wishes everyone,
Jodi Bassett
--
A Hummingbirds Guide to Myalgic Encephalomyelitis:
www.ahummingbirdsguide.com
--
M.E. is a systemic disease (initiated by a virus infection) with multi
system involvement characterised by central nervous system dysfunction which
causes a breakdown in bodily homoeostasis (The brain can no longer receive,
store or act upon information which enables it to control vital body
functions, cognitive, hormonal, cardiovascular, autonomic and sensory nerve
communication, digestive, visual auditory balance, appreciation of space,
shape etc). It has an UNIQUE Neuro-hormonal profile" Dr Elizabeth Dowsett

 

 

* * *

I'll quibble with one point.  Jodi says that ME patients are affected by heat.  According to Dr. Bell, the way to tell MS from ME is by the patient's reaction to heat, because MS patients will feel worse and ME patients will feel better.  I live in an area with extreme heat, and, in fact, I do feel much better in summer than in winter.

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