Friday, March 13, 2009

A doctor speaks out!


The MEA has sent in the reply below to an article in the current issue of the New Scientist magazine:


RE: started off as 'When illness is mostly in the mind' but later changed to 'How people can think themselves sick' - 11 March issue of NS by Clare Wilson


As a doctor with no mental health problems who developed ME/CFS as a result of a chickenpox encephalitis I can fully understand why people with this illness feel so angry when it is flippantly described as '...almost all in the mind' or 'How people can think themselves sick'.

Having an inaccurate or derogatory psychosomatic label attached to a condition creates all kinds of practical problems for patients - inappropriate or harmful treatments and refusal of certain benefits in particular - as well as discouraging biomedical research into the underlying cause.

Fortunately, there are clinicians and researchers who believe that ME/CFS has a solid physical basis involving infection, immunology, endocrinology and neurology.  As a result, the Medical Research Council has just set up an Expert Group to look at these areas of causation.

When it comes to treatment, The ME Association has just completed analysing the results from the largest survey of patient opinion ever carried out (4,000+ respondents).  Not surprisingly, these results clearly show that over 50% report that behavioural treatments such as cognitive behaviour therapy (CBT) and graded exercise therapy (GET) are either ineffective or harmful.

So please can the New Scientist return to the more objective position it took in 2006 (1) when it reported on neurological abnormalities in the spinal cord (ie dorsal root ganglionitis) in a 32 year old woman who died as a result of having ME and in 2005 (2) when it reported in abnormalities in gene expression - neither of which could possibly be caused by abnormal thought processes.

Yours sincerely

Dr Charles Shepherd

Hon Medical Adviser, ME Association
7 Apollo Office Court
Radclive Road
Buckinghamshire MK18 4DF



(1) Hooper R.  First official UK death from chronic fatigue syndrome.  New Scientist, 16 June 2006.

(2) Hooper R.  Chronic fatigue is not all in the mind.  New Scientist, 21 July 2005

Concerns raised by professionals about NICE

Examples of concerns raised by professional bodies about the NICE (draft)
Guideline CG53 on "CFS/ME"

Margaret Williams 13th March 2009

In his Approved Judgment in the Judicial Review of the NICE Clinical
Guideline 53 on "CFS/ME" released today, the Judge (Mr Justice Simon)
"The circumstances are not such as to lead a fair minded and informed
observer to conclude that there was a real risk of bias among the members of
the GDG." .

Commenting on today's Judgment, NICE's Press Statement says: "Professor
Peter Littlejohns, NICE Clinical and Public Health Director, responded to
the High Court judgment saying..We are pleased that all members of the GDG
and those involved in selecting the GDG were totally exonerated from the
unfounded claims made against them"
( ).

Stakeholder submissions and comments on the various chapters of the NICE
draft Guideline quoted below can be accessed in full at: . Although
some changes were made in the final Guideline in response to some of the
objections raised by these professional bodies, they were mostly superficial
alterations and the recommendation for behavioural interventions as the
primary management strategy for "CFS/ME" remained.

Association of British Neurologists: "it almost seems that a select group of
psychiatrists with a polarised view of this complex condition is directing
the development of the guideline from 'behind the scene' "

Association for Psychoanalytic Psychotherapy in the NHS :"It is highly
misleading to state that CBT is the therapy of first choice, since the only
relative efficacy RCT quoted in the Guideline shows that counselling has
better outcomes than CBT."

British Association for Counselling and Psychotherapy (BACP): "responses to
the Action for ME Membership Survey rate CBT and GET as the least helpful of
a range of interventions..."

British Dietetic Association: "It is unhelpful to simply state that
'Exclusion diets are not generally recommended for the management of CFS/ME'
when irritable bowel symptomatology is quite common in this illness."

Chartered Society of Physiotherapy: "If 50% get worse with GET, why suggest it as first line of treatment?"

College of Occupational Therapists: "The College has serious reservations
about the suitability of this Guideline."

ME Research UK: (Commenting on ".CBT is an evidence-based treatment for
CFS/ME.). It is not. The evidence base consists of only five trials which
have a validity score of less than 10."

National CFS/ME Observatory: "The belief that evidence-based guidelines can
be constructed on such an inadequate evidence base is, in our opinion,

National Coordinating Centre for Health Technology Assessment: "NICE largely
pays lip service to the principle of consensus, with patient evidence being
viewed as biased and virtually ignored".

NHS Fife: "as is common practice sale technique, the 'customer' is gently
led into a corner by a set of very cleverly designed questions aimed at
achieving agreement on everything the salesman offers."

NHS Plus: "the advice given to maintain exercise even when there is an
increase in symptoms is potentially harmful and dangerous, and the supposed negative effects of deconditioning would be negligible in comparison"

Royal College of Paediatrics and Child Health: "There is a danger in relying
solely on information from systematic reviews of clinical and randomised
trial reports for non-pharmaceutical treatments that are not easily defined
or replicated, such as CBT and GET."

Royal College of Physicians of London: "We think that this is a potentially
dangerous statement (ie.) that with increases in CFS/ME symptoms, exercise
or physical activity should be maintained to avoid the negative effects of
deconditioning. We are not aware of any clinician who would make this
recommendation, except in a very mildly affected patient."

Sheffield South West Primary Care Trust: "The narrow focus of the NICE
Guideline may lead to helpful approaches being undermined and patient
preference / clinical judgment being undervalued. All clinicians do not
subscribe to the 'CBT model of CFS/ME', and (it) does not seem to be well
received by many ME Support Groups either".


Association of British Neurologists

"The draft guideline is fundamentally flawed because it presupposes certain
interventions (CBT and GET) to be highly effective in CFS/ME for routine
clinical use despite lack of adequate evidence"

"The Guideline is also selective in its review of existing literature and is
heavily influenced by (the) psychiatric view of the condition. Indeed, it
almost seems that a select group of psychiatrists with a polarised view of
this complex condition is directing the development of the guideline from
'behind the scene' "

"There has been no review of general and post-exercise pain"

"The draft guideline reflects an incomplete and psychiatrically polarised
view of CFS/ME"

"The importance of appropriate diagnosis of CFS/ME from common psychiatric conditions has not been mentioned even once"

"No-where in this guideline have the exclusion criteria for CFS/ME (eg.
generalised anxiety disorder, somatisation) been adequately defined and
properly discussed"

" The guideline needs to be thoroughly revised to reflect our current
understanding of this condition rather than the supposition of the

"It would be immoral for NICE not to recognise the huge dissatisfaction
about this draft guideline amongst most patients, carers and clinicians"

"The guideline should not re-define CFS/ME to 'fit in' CBT and GET as the
recommended treatment options. Listen to patients".

A further submission from the Association of British Neurologists said the

"The GDG is neither competent nor empowered to redefine CFS/ME by using only
one of all the minor criteria: by doing so, the Group is tactically
promoting the Oxford (ie. Wessely School) criteria over the more widely used
and recognised international CDC criteria - again, a clear evidence of
psychiatrists' influence on this group"

"This paragraph deals with a publication (Wessely et al, Lancet 1999) which
was published as a HYPOTHESIS and which remains to be proven. However, the
GDG seems to have taken it as a matter of fact. Please refer to the
criticisms of this article in the Lancet. Being only a hypothesis, (it) is
totally irrelevant for the purpose of a dedicated guideline on CFS/ME"

"The GDG should also be criticised for its total lack of reference to the
neurological aspect of fatigue and its overemphasis and over-reliance on the
psychiatric literature from a group of psychiatrists"

"With the possible exception of some psychiatrists, most specialists prefer
the international criteria to diagnose CFS/ME".

"Clearly there is very little compelling evidence at present that these
patients benefit from CBT and GET" and the GDG recommendations for CBT and
GET are "both unsubstantiated and unjustified"

"There is selective omission of research literature on reproducible
neuroendocrine tests, with an overemphasis on research data from certain

Association for Psychoanalytic Psychotherapy in the NHS

"We are concerned that NICE is misleading patients and health professionals
on the question of CBT as the treatment of choice (for) patients who suffer
from CFS ... it is clearly unhelpful for people to be given misleading
advice or to have their expectations raised on a false basis.....there is
also evidence that many CFS sufferers do not find CBT suitable as a

"It is highly misleading for this to be the main recommendation"

"It is highly misleading to state that CBT is the therapy of first choice,
since the only relative efficacy RCT quoted in the Guideline (Ridsdale et
al, Br J Gen Pract 2001:51:462:19-24) shows that counselling has better
outcomes than CBT. This recommendation seriously conflicts with the
recommendation that patient choice and preference need to be uppermost in
the collaborative approach to care, and the finding that 45% of patients
report either being made worse or not helped at all by CBT and, elsewhere,
only 7% of patients surveyed report being helped by CBT
. Why is a
misleading recommendation being made?"

With reference to Ridsdale et al. (Chronic fatigue in general practice: is
counselling as good as cognitive behaviour therapy? A UK randomised trial.
Br J Gen Pract 2001): "the main findings of this study are reported - that
counselling is more cost effective than CBT, and that counselling has better
outcomes than CBT - followed by tortuous, vague and perverse reasons given
for why this guideline then chooses to ignore these studies - nor is any
explanation offered why they do not appear in the list of RCTs reviewed -
this seems to be a result of bias in the GDG, What is the reason for
ignoring the findings of this study in the recommendations?"

"Despite..good evidence for homeopathy from a high quality RCT, there is no
place in the recommendations for alternative therapy --- this contradicts
the general principle that patient preference should be given due respect".

British Association for Counselling and Psychotherapy (BACP)

"We see responses to the Action for ME Membership Survey rate CBT and GET as
the least helpful of a range of interventions....It would be a shame to
antagonise patient groups, which are often not convinced by the benefits of
CBT as demonstrated in clinical studies".

British Dietetic Association

"We wish to highlight the importance of optimum vitamin D status not only
for vulnerable groups of CFS patients...More evidence is appearing linking
low vitamin D status to lower extremity muscle weakness and immunity. We
would recommend the use of vitamin D supplementation of at least 10mcg. The
patient surveys indicate that dietary change helped 59 - 73% of patients"

"Many patients experience food intolerances and find a clinically supervised
exclusion diet a helpful tool in identifying those symptoms which may be
related to foods. We feel that this should be reflected here. People with
ME/CFS..clearly need straightforward and sensible advice that covers a wide
range of dietary management along with advice on the vitamins, minerals and
supplements that are extensively used and recommended to people with ME/CFS"

"There is no discussion on the use of EPA supplements which are probably the
most popular supplement currently being used by people with ME/CFS"

"It is unhelpful to simply state that 'Exclusion diets are not generally
recommended for the management of CFS/ME' when irritable bowel
symptomatology is quite common in this illness and there is good evidence to
show that exclusion diets can be helpful in identifying food intolerances"

"We note the discrepancy between the results of the surveys of patient
groups showing that a large number have found dietary change helpful (59% in
one survey and 65% in the other) and the final recommendations in the

(It should be noted that the stakeholder comments from psychiatrist
Professor Peter White's Chronic Fatigue Services at St Bartholomew's
Hospital dismisses the evidence of bowel problems in ME/CFS: "bowel symptoms
are not part of CFS/ME" ---stakeholder comments on chapter 6, page 143.

It should also be noted that the final Guideline does not recommend testing
for vitamin levels (even vitamin D, which is known to be very low in ME/CFS)
and supplementation specifically is not recommended).

British Infection Society

"Second line tests should include autoimmune serology".

(The Final Guideline does not mention testing for autoimmune serology).

Chartered Society of Physiotherapy

(Note that GDG member Ms Jessica Bavinton was nominated by The Chartered
Society of Physiotherapy).

"Can we clarify which name is preferable to use and identify that CFS/ME
falls within the umbrella of neurological conditions?"

"If 50% get worse with GET, why suggest it as first line of treatment?"

"Do not agree that the evidence-base is strong enough for GET"

"Are five reviews enough to describe a strong

"Was the GET definition / criteria the same in all five studies?"

"GET is dangerous without activity management first"

"Does not take individual reactions into account enough".

College of Occupational Therapists

"The College has serious reservations about the suitability of this
Guideline. Furthermore, the College believes that its implementation would
compromise essential services in this client group"

"It is disappointing that all the personal testimonies give negative
feedback about services"

"Are we now saying that all patients have chronic fatigue rather than
chronic fatigue syndrome?"

"The therapeutic relationship may be compromised if the patient refuses an
intervention because there may be no other intervention on offer and the
therapeutic relationship ends".

Counselling and Psychotherapy Trust

"We feel that it is restrictive and artificial to try to define approaches
such as GET (which is essentially a behavioural therapy programme)
separately, when (it) is frequently delivered as a component within an
integrated CBT framework. The real danger lies in the fact that definition
of GET as a separate area could well lead to any number of 'lay'
practitioners offering support, without adequate knowledge or skills (and)
errors can have severe detrimental effects".

Maidstone and Tunbridge Wells NHS Trust

"The warning about lower tolerances and more adverse effects from medication
certainly concurs with patient experience and is both welcome and important"

"Whilst thyroid hormone may appear normal on laboratory tests, the patient
may actually be clinically hypothyroid. It must be recognised that the
thyroid test has required updating numerous times".

ME Research UK

"The draft produced by the Guideline Development Group (GDG) is unsafe and
unsatisfactory ("unfit for purpose") because it does not engage with key
issues involved in the diagnosis and management of ME/CFS"

"Core areas of difficulty can be divided into the following: (i) the problem
of the diagnostic rubric and the need for research-based subsets (ii) the
skewing of the RCT evidence-base examined by the GDG, and the devaluation of
evidence from scientific studies and surveys (iii) the limitations of the
evidence-base for non-specific management"

"The WHO ICD has, since 1969, classified ME separately as a neurological
problem (G93.3), with 'CFS' incorporated into the current ICD as a sometime
synonym for ME. The chronic fatigue states per se are listed under mental
and behavioural disorders (F48.0), a category which specifically excludes

"Our key point is that CFS/ME or ME/CFS is a wide umbrella term recognised
by clinical champions, patient charities, leaders of ME/CFS support groups,
and scientific researchers to contain many different patient groups. Without
addressing this core issue, the efforts of the GDG to give diagnostic and
management guidance that goes beyond the recommendation of anodyne,
non-specific interventions will be inadequate and probably constitute

"The experiences of patients and the professional judgments of doctors are
important. It is not a simple battle between evidence and anecdote... NICE
needs to do more than just look at published science. It needs to start
listening to people, patients and doctors"

"It would be preferable for NICE and the GDG to recognise that specific,
rigorous, evidence-based recommendations for treatment cannot be made at
present than to incorporate an inadequate evidence-base into established
guidelines which feed into clinical care and government policy to the
detriment of people with ME/CFS"

(Commenting on " other chronic illnesses with no certain disease
process.) This leaves open the possibility that there might not be a
disease process at all, when there are thousands of people with a physical

(Commenting on ".CBT is an evidence-based treatment for CFS/ME.) It is
not. The evidence base consists of only five trials which have a validity
score of less than 10. We note that the most recently published RCT on CBT (O'Dowd 2006) states: 'there was, however, no evidence that the treatment restored normal levels of function for the majority of patients' "

"the rationale for using CBT in ME/CFS is that inaccurate beliefs /
ineffective coping maintain and perpetuate the illness, but it has never
been proven that these illness beliefs have caused or maintain the illness,
and correlations (where they exist) might just as well have arisen from the valid belief that the illness does have a physical cause, and that activity avoidance is the correct course of action"

(Commenting on ".GET is an evidence-based self-management approach to
CFS/ME.) It is not. The evidence base consists of only three RCTs with a
validity score of less than 10. Given that all three trials recruited
patients on the basis of the Oxford criteria which selects an over-broad
group of patients including those with idiopathic chronic fatigue...this
management approach cannot be properly called evidence-based or
cost-effective in ME/CFS"

(Commenting on ".Healthcare professionals should be proactive in advising
about fitness for work and education.) This is not a standard phrase used
in NICE Guidelines for other chronic conditions (and) there is a suspicion
that this phrase would not be written of patients with other illnesses.
What evidence is there that people with ME/CFS need unusual prompting from
healthcare professionals to return to their pre-illness lives and jobs?"

"This attempt by the GDG to define a clinical definition makes the situation
far worse. It introduces diagnosis based on 'fatigue' plus one of nine
vague, ill-defined symptoms shared with many other illnesses. The widened
diagnosis would include many thousands of patients currently diagnosed with
idiopathic fatigue (and) it would lead to significantly increased
heterogeneity within the diagnostic category and it would not be taken
seriously because it flies in the face of other expert opinion.
Furthermore, the experts devising the Canadian Consensus Document
(Carruthers 2003) derived a rubric based on characteristic symptom patterns
which reflect specific areas of pathogenesis"

"There is a clear mismatch between the recommendations of the GDG and the
routine examinations recommended by ME/CFS clinicians across the world"

(Commenting on ".When a diagnosis is made, a prognosis of cautious optimism
should be conveyed. With appropriate management, most children and adults,
but not all, will have some improvement and some will fully recover..) This
is not true. Two separate recent reviews have concluded that 'Substantial
improvement is uncommon and is less than 6%' (Andersen 2004) and 'Full recovery is rare' (Cairns and Hotopf, 2006)"

"Neither CBT (a form of psychotherapy designed to manage dysfunctional
illness beliefs) nor GET (which is used as part of a biopsychosocial
programme predicated on a model of physical deconditioning) are
evidence-based to a level that would allow NICE to recommend that these
management strategies be rolled out to the 120,000 - 240,000 people with
ME/CFS in the UK"

"Evidence from formal RCTs is opposed by evidence from patient surveys which
overwhelmingly find against the usefulness of these strategies.
Accordingly, the emphasis on these strategies in the NICE Guideline is

(Commenting on ".A programme of CBT should include.explanation of the CBT
model for CFS/ME.) There is no CBT model for ME/CFS. Rather there is CBT, a
form of psychotherapy, which can be applied to all illnesses through the
supposed biopsychosocial model"

(Commenting on ".discussion of the patient's attitudes and
expectations..developing awareness of thoughts or expectations.or
beliefs..challenging cognitions which may adversely affect rehabilitation or
symptoms management, for example fear of activity and perfectionist
beliefs..addressing symptom over-vigilance..) Such sentences,
characteristic of the biopsychosocial model, have been given undue
prominence by the GDG. There is a suspicion that they would not be so
prominently displayed in NICE guidelines for other illnesses; indeed, we
note that they do not appear in (the NICE Clinical Guideline on multiple
sclerosis) despite the fact that fatigue is one of the dominant symptoms of
most people with MS"

"The Analysis Report (2004) by the 25% ME Group for Severe Sufferers which
was submitted to the GDG is not mentioned in either the FULL or the NICE
guidance. This reported that 93% of respondents found CBT unhelpful and that GET was found to be unhelpful by 95%. It may be, as the FULL Guideline
says 'surveys from self-selected respondents are subject to bias'. But this
report is still valuable and full of meaning and does not deserve to drop
off the edge of the evidential world".

National CFS/ME Observatory

"Given our misgivings about the inadequacy of the evidence base pertaining
to CFS/ME, we are concerned that the current draft is premature. The belief
that evidence-based guidelines can be constructed on such an inadequate
evidence base is, in our opinion, misguided. Indeed, many of the
recommendations in the draft guideline appear not to be evidence-based at
all.. (and) reflect what limited research was carried out in the 1990s and

"If promulgated, even if subject to subsequent review, the guidelines are
likely to be in force for at least five years, during which time people with
ME receiving NHS care will be unable to benefit from whatever scientific
advances may be made"

"It also implies that, of a range of possible therapeutic approaches, CBT
and GET are the two which emerge as being the most effective, whereas the
reality is that there has been very little clinical trial activity involving
other treatment"

" The statement is also misleading because it does not consider at all the
extent to which outcomes of trials of CBT and GET .. do not appear
representative of the population with CFS/ME as a whole, are generalisable,
and applicable to that whole population"

"The diagnostic criteria detailed in paragraph do not conform to any
existing clinical case definition for CFS/ME and appear to be based on poor

"We do not consider that CBT and GET have been evaluated sufficiently for
this blanket claim as to their effectiveness to be justified"

"CBT and GET... should not be regarded as the first choice of treatment or
as providing a cure. To put rehabilitation before prevention or early
intervention falls short of the patient-centred approach which the draft
guidelines claim to be advocating"

"Greater evidence should be placed on medical interventions, including
symptom control and improved access by patients to services, information and

".promoting the use of CBT and GET in severely affected people (is)
extremely dubious, since there is a dearth of evidence supporting the use of
these approaches in such patients, and plenty of anecdotal evidence, as well
as evidence from surveys conducted by patients organisations, of these
methods being at best of limited value and at worst damaging. (In relation
to the use of CBT and GET in children and the severely affected, the draft
guideline) states that 'There is no evidence for the use or effectiveness of
these strategies in these two patient groups', and yet the guideline
recommends that they may be used in such cases"

"The (draft Guideline), as it stands, has obvious defects, which make it
unsuitable for general application throughout the NHS"

"It demonstrates lack of understanding of CFS/ME (and) the evidence-base is
inadequate to support the conclusions and recommendations made"

"The review claims to be evidence-based but in fact is mostly based on
expert opinion, rather than on evidence"

" There is no indication that the document reflects a balanced view of
expert opinion on CFS/ME"

" The report gives the erroneous impression that the role of these
management options has been satisfactorily evidenced and widely agreed by
professional and lay groups involved in this field"

"The recommendations serve only to underline the extent to which the
existing evidence base is inadequate"

"We strongly recommend that the draft be rewritten to reflect more
accurately the current state of scientific knowledge, and also the views of
stakeholders (and) patients' organisations, which do not appear to have been
taken much into account. NICE guidance is of such importance in the NHS,
and has such huge repercussions on patterns of treatment and care. It
therefore needs to be accurate. Where there are differences of opinion among
experts, such differences should be reflected in the document".

National Coordinating Centre for Health Technology Assessment

"NICE acknowledges that there is at present little good research evidence
for most aspects of ME/CFS and acknowledged the need for consensus methods.
However, NICE largely pays lip service to the principle of consensus, with
patient evidence being viewed as biased and virtually ignored".

Newcastle Primary Care Trust
"As many key questions did not progress to the wider group, we wonder to
what extent the stakeholder principle is being upheld".

Newport Pharamaceuticals Ltd

"Diagnostic Recommendations: this is a curious paragraph in a number of
respects: ME is a neurological illness (ref. The WHO classification), so why
would patients with neurological signs be excluded from diagnosis?"

"Cardiovascular abnormalities have been found in patients with ME (ref.
Human Tragedy and the Heart of the Matter - vascular research by ME Research

"Surely anxiety and depression indicate anxiety and depression, rather than
acting as markers for some 'seriously underlying pathology'. Of course
anxiety and depression should be treated in their own right if present. More
generally, the implication is that a diagnosis of ME/ICD CFS does not in
itself indicate a likelihood of 'serious underlying pathology'. Even if
'serious' is intended to be read as 'life-threatening', fatalities, though
rare, do occur (ref. Carruthers 2003, page 34), and the documented deaths".

NHS Fife

"The biomedical research evidence suggests it cannot be safely assumed that
negative effected reported by patients following exercise are attributable
to inappropriate application of what we are told is an intrinsically helpful
approach. However as is common practice sale techniques, the 'customer' is
gently led into a corner by a set of very cleverly designed questions aimed
at achieving agreement on everything the salesman offers. One system is
known as the Hierarchy of Effects model and is a marketing behavioural
response model. It is highly probable that participation in GET programmes
evokes a similar behavioural response from patients, thereby discouraging
disagreements with most statements made by the professional".

NHS Plus

"It is essential that this issue of deconditioning and exercise / rest is
resolved, since the advice given to maintain exercise even when there is an
increase in symptoms is potentially harmful and dangerous, and the supposed
negative effects of deconditioing would be negligible in comparison"

"Some research should be done on thyroid function. Levels of T3 and T4 and
TSH should be measured at times in all patients and readings scrutinised to
see if many are at the bottom end of the normal range. There is also
evidence to suggest that there may be some 'peripheral resistance' to
thyroid hormone in CFS/ME".

NHS Quality Improvement Scotland

"Supplements: again there is inconsistency: (NICE states)'There is no
evidence for the use of supplements', whereas the Full Guideline details
that there is some evidence for Essential Fatty Acids and magnesium. The
statement in NICE is misleading and potentially prevents many patients
deriving benefit from certain supplements. Another failing of the strictly
'evidence-based' approach".

North Bristol NHS Trust

"There is enormous concern amongst patients about who is doing the training
and what exactly they are being taught".

North Eastern Derbyshire Primary Care Trust

"This is another example of the GDG ignoring the consensus of the wider
group. The wider group actually agreed that a clinically supervised
exclusion diet followed by food challenges is appropriate where there are
bowel symptoms, however the NICE is worded such as to discourage this and
takes no account of the practical experiences of large numbers of people
with ME/CFS who often derive benefit from excluding certain foods".

PRIME (Partnership for Research in ME/CFS)
PRIME noted the GDG's acknowledgement that there are insufficient studies
using outcomes that are important to patients and that most studies often
assess only fatigue and sleep, and that few studies include outcome measures
that explore the wider impact of ME/CFS.

Royal College of General Practitioners (Wales)

"A guideline based on dysfunction and disability will inevitably remain
focused on rehabilitation rather than on cure and prevention".

Royal College of Nursing

"The current order seems to imply that CBT and GET are the most important
factors and this could be a source of upset with service users"

"Diagnosis to be considered if fatigue plus one additional symptom - what
sort of impact will this have on the number of patients being referred to
the CFS/ME services?"

"Not sure that this conceptual framework is helpful, nor does it help
clarify what CFS/ME is".

Royal College of Paediatrics and Child Health

"We note that only 63 / 219 participants in the consensus process were
healthcare professionals and it is unclear how many of these 63 had any
experience of managing children and young people with this condition"

"Further to the email sent to NICE on the 4th September (copy attached with
this response), we have the following concerns regarding the consensus
methodology process: The methodology is difficult / impossible to interpret
from the information given. Clearly this needs to be clarified as it
seriously undermines the document in its current form. For example, there
are several occurrences where a consensus appears to have been reached in
one round but the question has gone on to the next round. In at least one
situation it appears that a statement reached an agree consensus in the
first round but then continued to the second round where it reached a
disagree consensus"

"For many interventions there is a lack of evidence of efficacy"

"There is a danger in relying solely on information from systematic reviews
of clinical and randomised trial reports for non-pharmaceutical treatments
that are not easily defined or replicated, such as CBT and GET. It is only
by reading the actual paper describing the RCT does one see how the approach
described as CBT and GET differs from study to study"

"(NICE) says practitioners are advised to provide information on the
aetiology of CFS/ME - but where is the information to assist them in doing

"At a minimum could we have a reference here to the NSF (National Service
Framework, which includes ME/CFS as a chronic neurological disorder) for

"NICE recommends assessment of mental health is carried out before a
diagnosis is made. This does not appear to be evidence based and could
appear threatening in some situations"

"We are concerned that doctors reading this Guideline might interpret this
Guideline as that (sic) anxiety and depression are primary causes of CFS/ME
for which, as far as we are aware, there is no evidence".

Royal College of Physicians of London

"Unlike other NICE Guidelines, this document is a consensus document, with
evidence base limited to CBT and GET. It is important that the 'consensus'
nature of this document is highlighted, as it may be used in its own right
as a source of evidence base, ie. in the diagnostic, health planning or
medico-legal arenas"

"The consensus Guideline Development Group, with one exception, did not
include any single expert in major aspects of CFS, ie. clinical aspects or

"We do not believe that an acceptable definition of CFS/ME has been adhered

"The consensus group here have presented their own definition, which really
describes fatigue for four months with one of a limited number of other
symptoms. This opens up the diagnosis from CFS/ME into a wider remit of
fatigue disorders"

"If the consensus group are confident in this new classification, then this
should be emphasised and stated that the remit of these guidelines extends
to 'virtually any intrusive prolonged fatigue state' "

"Clinical evidence and patient experience suggest strongly that some
patients may be worsened by GET"

"We think that this is a potentially dangerous statement (ie.) that with
increases in CFS/ME symptoms, exercise or physical activity should be
maintained to avoid the negative effects of deconditioning. We are not
aware of any clinician who would make this recommendation, except in a very
mildly affected patient"

"There are many reasons for setbacks in CFS, including excess physical
activity or stress. If this is the case, and activity levels remain
unchanged, the patient is at risk of having a more major or serious
relapse. This needs to be emphasised"

"The Implementation Group expressed concern that...the wholesale
recommendation of CBT would not be practical in any 'reasonable timescale' "

" states 'there is no pharmacological treatment or cure for CFS/ME'. This is ostensibly true, but misses the point that...most patients have additional symptoms, eg. sleep disturbance, pain, anxiety, mood changes, new onset headache, bowel symptoms, allergies, vertigo etc. Without management of these symptoms the individual is unlikely to improve easily"

"It is stated that GET may be an appropriate addition to help patients
develop their physical capacity and functioning. GET in its traditional
form is not applicable, and not possible in the very severe dependent

Sheffield South West Primary Care Trust

"CBT and GET are mentioned several times. However, there may be other
approaches which are more helpful. Lack of evidence does not necessarily
mean lack of effectiveness for these approaches".

"The narrow focus of the NICE Guideline may lead to helpful approaches being
undermined and patient preference / clinical judgment being undervalued.
All clinicians do not subscribe to the 'CBT model of CFS/ME', and (it) does
not seem to be well received by many ME Support Groups either".

Good Quotes from Dr. Jason

"Symptoms get worse when body and brain are pressured to function beyond their current capabilities."
"Health care professionals MUST teach patients to monitor energy." 
"We need health care professionals who are not challenging patients' beliefs about their illnesses, but instead forming a therapeutic alliance with patients." 
This is quite a difference from the current nonsense where doctors badger patients to push themselves to do more to prove they're not just lazy! 
I was made much worse by trying to prove to doctors that I'm not "too lazy to work" (or do my own housecleaning).  When the New Jersey study about CFS patients being on the verge of cardiac failure came out, and I gave myself permission to act like a cardiac patient rather than someone who constantly has to prove herself to unbelievers, I saw my health start to improve, because I wasn't over-exerting all the time.  I made a point of staying within my limitations, hiring a housecleaner, putting my health ahead of other people's expectations ...
Dr. Bruno has noted that for most patients "it's more important to appear normal ... to protect themselves from criticism and failure than it is to ... care for themselves."  He also observes that depression is triggered when patients "can no longer meet other people's expectations and do what they think they 'should'."  It's a result, not a cause, and the medical profession must take responsibility that sometimes the cause for the patient becoming depressed is their bullying the patient to do more than the patient is physically capable of.
Doctors also need to take responsibility when their badgering a patient to "do more", "prove you're not lazy", results in a patient becoming even more debilitated.  They may not know that some patients have become permanently disabled from being pushed to exceed their physical limitations.


Tell your doctor

"It's not rocket science, but methodical thinking -- addressing one symptom at a time -- that helps CFS." -- Nancy Klimas MD
This is what I was taught, as well.  The first thing you should do is address the sleep issue.  Once you're getting good sleep, that should help your body begin to heal itself and reduce the number of things that need pharmacological intervention.
The problem is that most doctors don't do methodical thinking, they hear "tired" or "fatigue", leap to the conclusion you're just depressed, and CFS patients get worse when treated with anti-depressants.
Ampligen is currently available in Canada; they're hoping for an answer from US FDA in May
TELL YOUR DOCTOR:  is very clinician-friendly has their Medscape CME course online  lists clinical trials for a number of conditions -- Dr. Klimas found 60 for CFS -- it's not an exhaustive list (she noticed hers weren't on the list), but it'll help you find something in your area


Donations for CFS research and new CFS centers opening

At the CFS conference, I chatted up Judy Mikovitz from Whittemore-Peterson Institute.  They have a repository for tissue samples, but are not yet set up to take entire bodies.  (They're working on it.)
At this point, she recommends advising whoever is doing the autopsy to take the requisite samples for WPI's use.  In California, UCSF is working with them and knows what they want.
The necessary legal forms will be on "soon".
WPI in Reno should be open in 2010; Nancy Klimas is working on her own Center to open this summer in Miami


Tuesday, March 10, 2009

More on CFS and Polio

For an understanding of why I'm reading this book, you'll want to skim a previous post:
Dr. Dowsett recommends: "M.E. Research workers must be encouraged and appropriately funded to work in this field. However they should first be directed to papers published before 1988, the time at which all specialized experience about poliomyelitis and associated infections seem to have vanished mysteriously!"
                                   % % %
After watching "American Experience: Polio" on PBS last month, I ordered the book "Polio: An American Story" by David M. Oshinsky on which the show was based.
"A majority of the victims were male, a finding that would mark future polio epidemics." How interesting. Boys get polio, girls get CFS. Hmmmmm. (My favorite polio patient is female, and some of my top CFS activists are male, so it's not as clear-cut as some diseases, i.e., 100% of prostate patients are men.  Depending who you talk to, ¼ to 1/3 of CFS patients are male.)
He cites an unnamed researcher "A key assumption in the American value scheme is that misfortune rarely touches those who take the proper precautionary measures."  Yep, I've been called a liar when I say that I got sick while eating healthy food and exercising daily, don't smoke, barely drink.  I had to have been doing something wrong.  The only thing that I could've done to avoid getting sick was to be totally germophobic and lock myself in my nice clean apartment for the duration of flu season, refusing to even leave to go to work, but that would get me a different sort of criticism.  The standing joke when I was a kid was that I never got "sick", I got "deathly ill". Obviously, I had a strong immune system, because I didn't get a lot of simple colds; I only got the stuff that could kill you. And here's another thing strong enough to overwhelm my system; the 104-105 fever for days is proof that this was not just a minor illness that could've been avoided by eating more veggies.
They took blood samples from every patient during one epidemic, but only one had poliovirus, a child who wouldn't have even been brought to the hospital except for the fact that there was the epidemic and parents were freaking over any little thing.  "Why had previous researchers been unable to detect poliovirus in the blood? The answer was deceptively simple: they had waited too long to begin looking. When poliovirus enters the blood, it creates the very antibodies that will soon destroy it. Thus, poliovirus can be found there only during a brief period of incubation BEFORE these antibodies have formed."
Maybe that's why no one's ever been able to find the CFS virus? By the time any of us realize that it's more than just stomach flu, the virus is gone, "the antibodies it has produced have fully neutralized the virus."  Dr. Bell, lo these many years ago, did say something about viruses being untestable after a few months, i.e., by the time we've reached the 6-month threshold for impairment to warrant the CFS diagnosis, it's too late to go looking for which virus is involved.
It certainly does pose a problem for research if the virus is gone before we can be diagnosed. But hope springs eternal.
Incidence of polio peaked at 37 per 100,000 in 1952.  So, while it may be a seriously potent disease, it's fairly rare. One newspaper noted that "three times as many people in this country die of homicide as die of polio."  According to the book, there are 400,000 survivors of paralytic polio in the US; by the most reliable statistic (i.e., not including misdiagnosed psych problems) there are 1,000,000 CFS patients.
By 1954, "two-thirds of the nation had ... donated money to the March of Dimes ... and seven million people had volunteered."  If only we could get that proportion involved in the fight against CFS! (Some experts believe CFS is a close relative of polio, noting numerous similarities to post-polio. See the above-referenced article about Dr. Bruno.)
Like CFS, where the younger patients seem to recover better, "the chances of serious paralysis and death seemed to rise dramatically with age."  However, the post-polio experience may have some warnings for us: "those who endured the severest cases of polio and made the greatest functional recovery are the most likely to be affected" by post-polio.   I had a pretty severe virus, and made a very good recovery – for 12 years, I passed for normal at work – but when I crashed in 2000, I crashed hard, to the point that some doctors felt I had to be exaggerating my symptoms because they couldn't possibly be that bad.
Starting in 1955, the polio vaccine became available, and by the mid-60s, just about everyone in the US was getting it.  However, the book points out that the vaccine is not 100% effective – it was only 60-70% effective against Type I poliovirus (the paralytic version) and 90% effective against Type II and Type III.  Therefore, even those of us who had the vaccine may have gotten the poliovirus, since it's not 100% effective. 
Dr. Halstead noted "Without a name there is, in essence, no disease.  Having a name – even if imprecise and misleading as to causation – at least confers an element of credibility."
"Since 1987, Rotary International has raised $500 million to immunize the world's children against polio.  (The Bill and Melinda Gates Foundation has contributed more than $1 billion...)" I think we need to lobby the Gateses with the theory that CFS is related to polio, and see if we can get them to donate enough research funding to finally get that breakthrough that allows us to start immunizing people against CFS.
On a personal note, one of the Acknowledgments is "Professor Dan Wilson of Muhlenberg College, a kind, wise and courageous man, spurred my interest in polio."  I've met Dan and have the same opinion of him.  (Hi, Dr. Wilson!)

A Plea for Letters

To everyone out there with cfs/me and those that care for them:

The nih budget has been slashed from 5 million to 4 million.
Despite affecting more than a million americans it is much more poorly funded than
diseases affecting far fewer people. It would appear that the NIH is contemptuous of
people wth CFS/ME based on their behaviour in the past 10-12 years (e.g. closing
down all three CFS centres of excellence)

The CDC, in turn, are not currently conducting research that is in the best
interests of the patient community.

It is very important that everyone in the US writes to their elected representative
to protest this state of affairs.

In addition to the government funded research there has to be a parallel, privately
funded research track. This is essential at least until we reach a point where
public health officials start taking CFS/ME more seriously.

Given the invisible nature of the symptoms,the fact that where people do die from ME,
it takes many years and is usually due to a complication and also due to the fact that
it has been very hard to reproduce abormalities uncovered in studies, this may all take
quite a few years.

In the meantime the majority of patients with ME/CFS are on their own mission,
looking for protocols and 'forward thinking' medical practitioners to treat their

If cancer was still poorly researched and patients devalued, do you think
the answer would be to go haywire for new supplements and at best experimental
treatment protocols, instead of writing their senators and supporting research??

People with ME/CFS are devaluing and deligitimising this illness by spending
disproportionate amounts of money on unproven treatments at the expense of
supporting conventional researchers with a proven track record in researching this

People often write back to me saying that they can't wait for science to
produce the answers. What should we depend on then alchemy? The quicker we take the
initiative to invest in quality non psychiatric, biomedical research, the quicker
things will start looking brighter.

I have had ME for 15 years now and I wish I had started investing in
research sooner. I too used to tell myself that I couldn't wait for science to
produce an answer but 15 years have gone by in a flash and the situation is not

The CFIDS association had to beg and plead with the ME/CFS community to come
up with 1 million dollars, effectively 1 dollar per person ill in the US.
Terrifyingly they raised this money from only 1000 individuals, including an
individual donation of 100000 dollars.

This situation has to change. Unless we realise that we are all in the same boat,
metaphorically speaking, the research situation ( together with our prospects of a
better quality of life through proper treatment) is unlikely to improve.

If it matters so much to us and if we take this illness seriously, then surely we
will do the rational and logical thing and support conventional research


1.The ME association's Ramsay research fund

2. ME Research UK

3. IACFS/ME-1 million dollar research drive

Thanks for taking the time to read my plea.

Jeremy Bearman


Monday, March 9, 2009

Why is there no money for research?

Dr. Hanna, the head (and sole employee!) of the NIH's ME/CFS research program has repeatedly said that the NIH budgetary problems mean that there's simply no money available to increase the programs (paltry) funding.

But is that true? A close look at the situation suggests an alternate explanation for the program's troubles. Check it out at

on the new Phoenix Rising site. And subscribe to the blog!

(Next Up: It's raining money at the NIH )

* * *
Direct link to that post

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Dr. Sharon Kirk

From the back of "When I Cry Wolf: A Society Lost to Chronic Fatigue Syndrome
and Mold" by Sharon Kirk, PhD.

"Sharon Kirk, PhD, received her degree at the Pennsylvania State University in
Speech Communication, an interdisciplinary field in which she studied
psychology, philosophy and communications. She was a professor at LaSalle
University in Philadelphia. She has done research in various areas including
Chronic Fatigue Syndrome (CFS).

Dr. Kirk has worked in private practice as an individual, couple and family
therapist working with all populations and issues, although her area of
expertise is working with people who have chronic illnesses:

- CFS, also known as Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS)
- Myalgic Encephalomyelitis (ME)
- Multiple Chemical Sensitivity (MCS)
- Environmental Illness (EI)
- Sick Building Syndrome (SBS)

Dr Kirk's expertise on CFS is highly regarded, not only because she has taught
and researched the subject and counseled PWC's, but also because she has
suffered with CFS for nearly two decades. She knows what it's like to be
bedridden for years, to attempt to do things on her own when she is too tired to
think and cope with the demands of daily living. She knows what it is like to
have lost virtually everything.

Able to function for the first ten years of her illness, Dr. Kirk then moved
unaware into a house filled with mold that increased the severity of her
symptoms. At that time she had to stop working. Dr. Kirk is currently living on
disability. She hopes to return to counseling PWC's in the future.

Dr. Kirk has lived and studied in Seattle, New York City, Illinois, Europe, and
the Middle East. She and her dog, Shadow, now reside temporarily in Blue Bell,
PA. As soon as she is able, she will relocate to Lancaster, Pennsylvania where
she hopes to have built an environmentally safe log home beside a stream. She
intends to organize a respite house for PWC's to stay for short periods and
assist them as they decided the next step along their journey."


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CFS Quackery

These are the questions...
- What are the motives of CFS-quacks ?
- What is wrong in the CFS community (and in the world itself) ?
- Why ain't PWCs allowed to recover ?
- What's wrong with scientific research into CFS ?
- Why isn't there any progress ?
- What is *really* going on here ?

You will find the answers to these questions at,

It's the ultimate horror story - and it can be observed *everywhere*
around us. But most of us just don't see it.

Dr. Marc-Alexander Fluks

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