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More potential dangers of the UK NICE Guideline on "CFS/ME" for
people with ME/CFS?
Margaret Williams 2nd January 2008
Much has been written about the NICE Guideline on "CFS/ME" since its
release on 22nd August 2007, mostly noting concern over the
Guideline's recommendations that cognitive behavioural therapy and
graded exercise therapy (CBT/GET) should the first-line (and only)
management for "Chronic Fatigue Syndrome / Myalgic
or "CFS/ME". This concern is unsurprising, given the existence of
numerous published papers which all conclude that CBT is of limited
and non-lasting benefit, and given that at least four major surveys
of over 3,200 patients with ME/CFS have clearly shown GET to be
"CFS/ME" is different from ME/CFS, the former being the psychiatric
model which has no abnormal signs or laboratory findings (i.e.
chronic somatisation disorder) proposed and favoured by Wessely
School psychiatrists who advise Government Departments on "CFS/ME"
and who are believed to exert control over the Medical Research
Council's funding agenda, whilst the latter is a nosological
neurological disorder (classified as such by the World Health
Organisation) which exhibits distinct signs and has an abundance of
abnormal laboratory findings, albeit no single, definitive test.
It is a matter of on-going concern that the psychiatric lobby
continues to use the terms ME, CFS and chronic fatigue (CF) as if
they were interchangeable, when such is not the case.
Virtually none of the peer-reviewed, published biomedical evidence
seems to penetrate the consciousness of these psychiatrists and
supporters, who continue to dismiss or ignore the ever-mounting
confirmation of abnormal laboratory investigations now known to
in ME/CFS. What is so curious is that there is such an abundance of
easily accessible evidence of abnormal laboratory findings in
so how -- without losing credibility -- can the psychiatric lobby
keep asserting that none exists?
Not only is this evidence down-played, its very existence is
repeatedly denied: in an in-press article to be published in
Psychoneuroendocrin ology, James Jones from the Division of Viral
Rickettsial Diseases at the US Centres for Disease Control also
to ignore this body of biomedical evidence, claiming: "In the
of overtly abnormal findings in a person with prolonged duration of
illness, it is common for practitioners to consider a psychological
explanation during clinical evaluation" ("An extended concept of
altered self: Chronic fatigue and post-infection syndromes". James F
Jones. Doi:10.1016/ j.psyneuen. 2007.11.007) .
For Jones to propose in his essay that:
(i) "the illnesses in question stem from responses to previous
infections and not to ongoing viral or immunologic factors"
(ii) interoception is responsible for the illness behaviour
by patients ( "the sensations and consequences of sickness behaviour
(iii) "persistent illnesses such as CFS are due to maladaptive
biological (interoceptive) signal recognition"
(iv) "It is of interest that CBT remains an effective therapy for
(v) "Chronic illnesses, such as CFS, in the absence of evidence of
standard mechanisms of pathogenesis, require new concepts of illness
seems remarkable, given that in 1996 Jones was one of the authors of
a paper that provided laboratory evidence for an autoimmune
in ME/CFS (see below).
Royal Society of Medicine meeting to support the NICE Guideline
It is a matter of acute concern that the Royal Society of Medicine
to host a meeting on 28th April 2008 on "CFS" (reference to "ME" is
omitted, which is in keeping with the Wessely School's documented
intention to eradicate the term) at which the psychiatric lobby is
provide most of the speakers; not only do those speakers include
Professor Simon Wessely himself (famous for his trenchant belief
ME is a myth and that it does not exist except as an aberrant belief
in the mind of those who think they suffer from it), but other
believers in the psychosocial model of "CFS/ME" such as Professor
Peter White; Dr Anthony Cleare; Professor Rona Moss-Morris and
Professor Matthew Hotopf. Professor Anthony Pinching is to chair
Session Two. Pinching is widely-known for his belief that in
ME/CFS, "over-investigation can [cause patients] to seek abnormal
test results to validate their illness", that "fatigue [is] not
related to ongoing exertion" and that "The essence of treatment is
activity management and graded rehabilitation" (as set out in
Prescribers' Journal 2000:40:2:99- 196). Sir Peter Spencer, CEO of
charity Action for ME, is to speak in Session Three (to be chaired
Professor Mansel Aylward, formerly Chief Medical Adviser to the DWP
and now funded by the notorious medical insurance company UNUM).
Another speaker is Professor Chris Dowrick from Liverpool, who, with
Rona Moss-Morris is one of the authors of a study for which the MRC
awarded £459,707, the results of which were published in the British
Journal of Psychiatry: 2007: December:191: 536-542 ("Cluster
randomised controlled trial of training practices in reattribution
for medically unexplained symptoms"). The object of the study was to
teach general practitioners that "reattribution" of symptoms
a psychological explanation for medically unexplained symptoms in
disorders such as "CFS/ME".
Another danger of the NICE Guideline?
Given the wall-to-wall influence of the Wessely School lobby and the
choice of members of the Guideline Development Group that produced
the Guideline on "CFS/ME", it is little wonder that NICE got things
There can be no doubt that NICE ignored the international evidence
that ME/CFS is a biomedical, not psychiatric, disorder, claiming
studying this evidence fell outwith its remit. Such a claim is
mystifying, since knowledge of the existing evidence-base ought
surely to be mandatory before producing a national Guideline on the
management of any disorder, especially given that adherence to such
Guideline is obligatory throughout the NHS (and hence for affiliated
agencies such as the Department for Work and Pensions and Social
Not only has the "evidence-base" upon which NICE relied for its
recommended management interventions for ME/CFS been exposed as
deeply flawed by virtue of the heterogeneous populations studied;
methodological inadequacy; the corrupted data; the high drop-out
rates; the undeniable ineffectiveness of CBT/GET as shown by the
outcomes measures, and the finding that the claimed benefits may
been illusory ( see: "Inadequacy of the York (2005) Systematic
of the CFS/ME Medical Evidence Base" by Malcolm Hooper & Horace Reid
at http://www.meaction uk.org.uk/ FINAL_on_ NICE_for_ Gibson.html )
just as importantly, the proscribing by NICE of appropriate testing
and its stipulation that any vitamin or mineral deficiency must not
be corrected by prescription would seem to constitute a real and
life-threatening danger to people with ME/CFS - see below.
The proscribing by NICE of testing for Vitamin D status in patients
This is particularly problematic in respect of vitamin D status
which, according to clinicians who specialise in ME/CFS, is known to
be frequently deficient in patients with true ME/CFS. If serum
vitamin D levels are low, one might expect the serum calcium level
be low and the alkaline phosphate (ATP) level to be high, but in
ME/CFS this seems not to be so. Normal screening rules simply do not
apply in this disorder.
It seems that some doctors still believe that vitamin D relates just
to the health of bones, and that a lack of vitamin D solely results
in osteomalacia or in osteoporosis (a thinning of the bone
predisposing to multiple fractures).
Whilst this is indeed so, nothing could be further from the whole
Vitamin D is a misnomer because it is now known that it is more than
just a vitamin - it is a precursor of a steroid hormone that affects
the entire body. Receptors that respond to vitamin D have been found
in almost every type of human cell from brain to bone ( see:
www.mercola. com ).
It should be noted that whilst this website (run by Dr Joseph
MD) is useful and informative in many ways, it is essentially an
advertising website and contains some information which some
clinicians might challenge.
Vitamin D represents D2 or D3. The former is known as ergocalciferol
and the latter as cholecalciferol.
Whilst vitamin D2 occurs naturally in fungal form (usually
medically prescribed vitamin D2 is usually a synthetic form, which
according to some sources has been shown to cause toxicity and to
have greater potential for harm (see "Test Values and Treatment for
Vitamin D Deficiency" at www.mercola. com ).
Vitamin D3 is the natural form (i.e. the same vitamin D that the
makes when exposed to sunshine).
Vitamin D3 is converted 500% faster than vitamin D2.
Currently there is much debate as to whether recommended levels of
vitamin D in the diet are sufficient for people living in northern
latitudes, but over-supplementatio n is dangerous and can lead to
vomiting, kidney failure and calcification of the arteries ( see
www.mercola. com ) and it is essential to consult a doctor
specialising in the field.
With regard to supplementation, it is perhaps worth mentioning that
one GP who specialises in ME/CFS (Dr Sarah Myhill, a leading member
of the British Society for Allergy & Environmental Medicine / BSAEM)
apparently prescribes 0.5 micrograms of calcitriol (ie. the active
form of 1,25 dihydroxyvitamin D - see below) for patients with
depleted vitamin D levels, which is manufactured by a company called
Teva Ltd (0113 - 238 - 0099).
The Medical Information department of this company has confirmed
they use wholly synthetic products in the manufacture and that in
addition to the active (synthetic) ingredient, their calcitriol
contains butylated hydroxyanisol (E321, a "red" or dangerous
substance [BHA/BHT] to which people with ME/CFS who have
hypersensitivities might react badly: BHA has a benzene / phenol
and was developed to protect petroleum from oxidative gumming,
BHT [toluene] is methylbenzene derived from petroleum; it is used as
a solvent in aircraft fuels); coconut oil; gelatine for the capsule
from a mixture of both porcine and bovine sources; glycerol;
sorbitol; titanium dioxide (E171); quinoline yellow (E104,
another "red" or dangerous substance and a coal tar dye that has
banned in the US, in Australia, in Norway and in Japan, but not in
the UK, even though the UK Committee on Toxicity acknowledged the
evidence that it inhibits cholinesterase activity in in vitro human
red blood cells and plasma, and assays have shown that quinoline
yellow is genotoxic); patent blue (E131, another "red" coal tar dye
and a dangerous substance). In addition, each capsule contains
refined shellac and black oxide used in the printing ink.
Ranges of Vitamin D
Vitamin D from the skin and diet is metabolised in the liver to 25-
hydroxyvitamin D (25 (OH)D), known as calcidiol. It is this that is
used to determine vitamin D status. 25(OH)D is in turn metabolised
the kidney to its active form of 1,25 dihydroxyvitamin D (1,25(OH)
known as calcitriol).
Optimal range is now considered by world experts to be 45-50 ng/ml
(nanograms per millilitre). Twenty-five nanograms equates to one
International Unit (the measure in which supplementation is usually
Below 40 ng/ml is considered sub-optimal; below 30 ng/ml is
deficient; below 20 ng/ml is now considered seriously deficient, and
below 10 ng/ml places the patient at real risk, requiring prompt
intervention. Experts recommend that, ideally, the vitamin D level
should never be below 32 ng/ml ( see www.mercola. com ).
In ME/CFS, levels as low as 8.3 ng/ml have been recorded.
The NICE Guideline on "CFS/ME", however, is categoric: not only is
testing for vitamin D status proscribed, but the prescribing of
vitamin supplements to rectify any deficiency is specifically
forbidden: the Guideline states that supplements to correct any
vitamin or mineral deficiency "should not be prescribed for treating
the symptoms of the condition" (see the 52 page version of the
Guideline, page 24, paragraph 184.108.40.206).
Quite how cognitive behavioural therapy and graded exercise can
deficient levels of this vital and life-saving hormone that are
in ME/CFS patients is not explained by NICE.
Effects of deficiency of Vitamin D
Deficiency results in chronic illnesses, specifically in symptoms
that occur in ME/CFS: deficiency impacts on muscle function (with
muscle pain and weakness) and is a risk factor for cardiovascular
disease (CVD risk is documented in the ME/CFS literature and was the
subject of keynote lectures at the international research conference
hosted on 25th May 2007 by ME Research UK in Edinburgh). A deficient
vitamin D status is known to result in high blood pressure, with the
consequent dangers of heart attack or stroke (see "Vitamin D
Deficiency". Michael F Holick MD PhD; NEJM 2007:357:266- 281; see
also "Ultraviolet B and blood pressure". Rolfdieter Krause, Michael
Holick et al. Lancet 1998:352:709- 710), and in raised triglycerides
(see "Prevalence of Cardiovascular Risk Factors and the Serum Levels
of 25-Hydroxyvitamin D in the United States". David Martins et al.
Arch Intern Med: 2007:167:1159- 1165).
Vitamin D is an essential part of the endocrine system (which is
documented as being disrupted in ME/CFS) and it controls several of
the adrenal hormones, production of enzymes and the growth of cells
www.mercola. com: interview with William B Grant PhD of the
Nutrition and Health Research Centre, one of the top vitamin D
Deficiency of vitamin D has also been implicated in inflammatory
disorders such as ME/CFS is increasingly being demonstrated to be
(see "Higher serum vitamin D concentrations are associated with
longer leukocyte telomere length in women". T Spector et al. The
American Journal of Clinical Nutrition, 8th November 2007) and in
autoimmune disorders such as multiple sclerosis, rheumatoid
and diabetes (see "Vitamin D Deficiency". Michael Holick MD, PhD:
NEJM 2007:357:266- 281).
It will be recalled that some experienced ME/CFS researchers -
including Professor Kenny De Meirleir from Belgium -- now hold
to be an autoimmune disease and that evidence of autoimmunity was
presented at the fifth AACFS International Research and Clinical
Conference held in 2001 in Seattle. This was a major multi-centre
study looking at the presence of autoantibodies to a cellular
expressed primarily in neuronal cells (MAP2). Initial studies with
immunohistochemistr y showed a high percentage of (ME)CFS sera
reactive to centrosomes and that other proteins besides MAP2 might
also be target antigens in (ME)CFS autoimmunity (see "A multi-centre
study of autoimmunity in (ME)CFS". K Sugiura, A Komaroff, E Tan et
al. AACFS #037).
Previously, a 1996 paper demonstrated the occurrence of
autoantibodies to a conserved intracellular protein (lamin B1),
provides laboratory evidence for an autoimmune component in ME/CFS.
The authors found that 52% of patients with ME/CFS develop
autoantibodies to components of the nuclear envelope (NE), mainly
nuclear lamins, suggesting that in addition to the other documented
disturbances of the immune system, humoral autoimmunity against
polypeptides of the NE is a prominent immune derangement in ME/CFS.
67% of ME/CFS patients were positive for NE reactivity compared with
10% of normal subjects. No patients with either depression or atopy
showed reactivity to NE proteins. Autoantibodies to NE proteins are
relatively infrequent and most fall into the category of an unusual
connective tissue disease subset characterised by brain or skin
vasculitis (see "Autoantibodies to Nuclear Envelope Antigens in
Chronic Fatigue Syndrome". K Konstantinov, James Jones, Eng Tan et
al. J Clin Invest 1996:98:8:1888- 1896). Many patients with ME/CFS
report a vasculitic-type headache which has become known as "the ME
The paper concluded that such activation "could be the result of
various triggering agents, such as infections or environmental
toxins". It recommended that: "Future work should be directed at a
better understanding of the autoimmune response of CFS patients to
other NE antigens".
This important paper has been widely cited in, for example: American
Journal of Psychiatry:2003: 160(2):221- 236 (N Afari and D
Clin Vaccine Immunol: 2002:9(4):747- 752 (BH Natelson et al); Brain
2001:124(9): 1821-1831 (RK Gherardi et al); Rheumatology: 2001:40
(7):806-810 (M Nishikai et al) and Journal Watch:1997:314: 4.
It therefore surprising that one of the authors (James Jones) now
seems to regard ME/CFS as maladaptive interoceptive signal
Not only is deficient vitamin D implicated in autoimmune disorders,
it is also known to be implicated in at least 16 different types of
cancer, especially pancreatic, lung, breast, ovarian, prostate and
colon cancers ( see www.mercola. com ). A landmark study from the
Moores Cancer Centre at the University of California found that some
600,000 cases of breast and colorectal cancer could be prevented
year, if only vitamin D3 levels were increased.
Quite apart from being implicated in pancreatic cancer, low vitamin
is also known to affect pancreatic function, and pancreatic
dysfunction is well-documented in ME/CFS.
As well as being implicated in common cancers, autoimmune diseases
and cardiovascular disease, there is evidence that deficient vitamin
D levels are implicated in infections: vitamin D can increase the
body's production of naturally occurring antimicrobial peptides
destroy the cell wall of viruses and bacteria (see www.mercola. com;
see also "Vitamin D Deficiency". Michael F Holick as above) and a
deficiency is also implicated in seizures (see
http://news. bbc.co.uk/ 1/hi/health/ 7161458.stm ).
Holick, a world expert on vitamin D, states that 1,25
dihydroxyvitamin D controls more than 200 genes, including genes
responsible for the regulation of cellular proliferation,
differentiation, apoptosis and angiogenesis, and that it is also a
potent immunomodulator, as well as increasing insulin production and
myocardial contactability. Vitamin D deficiency is associated with
congestive cardiac failure and blood levels of inflammatory factors
including C-reactive protein and interleukin- 10.
Given the immense importance of vitamin D, and given the fact that
people with ME/CFS are known sometimes to have inordinately low
levels, and given the protean symptomatology arising from a
deficiency, it is disturbing that NICE precludes both testing for it
and the prescribing of supplements to raise the level if necessary
for patients with ME/CFS.
It would seem to be imperative that patients suffering from ME/CFS
take charge of their own management and either persuade their GP to
act against the NICE Guideline and check their vitamin D status
(which in the UK, may mean sending blood to a specialist laboratory
in Manchester and is expensive to do) or consult a private clinician
specialising in ME/CFS.
For people within travelling distance of London, one such clinician
is Dr William Weir, whose details are on the Co-Cure UK Good Doctor
List (http://www.co- cure.org/ Good-Doc. htm ). Dr Weir works part-
as a Consultant Physician in the NHS but he also runs a private
ME/CFS Clinic at 10, Harley Street, London W1G 9PF (telephone: 0207 -
467 - 8478) and he now routinely checks vitamin D levels in all his
The Doctors' Laboratory (55 Wimpole Street, London W1G 8YL,
0207 - 460 - 4800) also carries out the 25 (OH)D test. A referral
from a medical practitioner is required, but blood can be sent by
post in a serum tube and must arrive within two days. If sent by
by a medical practitioner, the cost is £40, but if a patient is
referred and attends in person to have blood taken, there is an
additional service cost of £29.
There are numerous sources of vitamin D3 supplements that do not
contain excipients; one such company is Biocare (telephone 0121 -
433 - 3727), whose supplement contains only lanolin (the source of
D3) in extra virgin olive oil (but some people with ME/CFS may be
unable to tolerate lanolin). There are different strengths of the
A more efficient way of increasing vitamin D levels may be by using
lamp specifically made for the purpose. One such lamp is the Xiris.
It is made in Italy and can be obtained from Allergy Matters
(telephone 0208 - 339 - 0029). It comes with full instructions and
Alternatively, provided that the support of clinicians can be
obtained and for those fortunate enough to have access to an NHS
phototherapy unit (within a Dermatology Department), personalised,
carefully titrated and monitored phototherapy is available on the
The NICE Guideline on "CFS/ME", however, may prove to be a barrier
impossible to surmount.
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