Dangers of the UK CFS/ME NICE Guideline

[Guest guest]

Dear Readers / Friends,

An hour ago I awoke very sick, out of a sleep from

Thursday 19 o'clock till Friday 21 o'clock, with a hard

pounding heart, a terrible head age and shaking

hands. And I'm yearning for sleep again.

Some of you may know, that I suffer from a severe

writing-aphasia because of ME; so at the moment I

can't explain why I couldn't (and can't) handle my

bulletin *Help ME Circle*.

I hope that I will come back in the near future;

probably with a much lower sequence. But my pc

don't work; I have to reinstall XP, which is a hell of a

job.

I just received a very interesting article written by

Margaret , which I can't resist to post.

It is not only important for the UK, but also for

Europe (see for example the fraudulent report of the

Dutch Health Council of The Netherlands - in which

all the bio-medical research is completely omitted -

http://www.gr.nl/pdf.php?ID=1169 & p=1 - and of

course the USA.

The CDC is slowly on busy to gear their politics to

the ideas of the patron of the insurance- and

war-industry Simon Wessely. With the " redefined "

Reeves's guidelines the prevalence of *CFS* is from

one day to the other 6- to 10-fold higher than

before.

By mixing more and more psychological disorders

into the FATIGUE-soup, as they already did in 1994

(Fukuda/UNUM-Sharpe) in which the hallmark of

ME/ICD-CFS *post-exertional malaise* was NOT

mandatory - that's the real reason, why findings in

research are so inconsistent - the authentic,

neurological, multi-systemic disease ME and ICD-CFS

(which was of course based on *ME*-outbreaks in

the USA) will completely disappear.

Jan van Roijen

(about five hours later)

````````````````

http://www.meactionuk.org.uk/Dangers_of_NICE_for_MECFS.htm

Permission to Repost

More potential dangers of the UK NICE

Guideline on *CFS/ME* for people with ME/CFS?

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Margaret

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 Encephalomyelitis " 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

actively harmful.

*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 their

supporters, who continue to dismiss or ignore the

ever-mounting confirmation of abnormal laboratory

investigations now known to exist in ME/CFS. What

is so curious is that there is such an abundance of

easily accessible evidence of abnormal laboratory

findings in ME/CFS, 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 Psychoneuroendocrinology,

from the Division of Viral and Rickettsial

Diseases at the US Centres for Disease Control also

seems to ignore this body of biomedical evidence,

claiming: " In the absence 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 " . F

. Doi:10.1016/j.psyneuen.2007.11.007).

For 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 exhibited by patients ( " the

sensations and consequences of sickness behaviour

are remembered " )

(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 CFS " and

(v) " Chronic illnesses, such as CFS, in the

absence of evidence of standard mechanisms of

pathogenesis, require new concepts of illness origin "

seems remarkable, given that in 1996 was one

of the authors of a paper that provided laboratory

evidence for an autoimmune component 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 is 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 to provide most of the speakers;

not only do those speakers include Professor Simon

Wessely himself (famous for his trenchant belief that

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 devout believers in the

psychosocial model of *CFS/ME* such as Professor

White; Dr Cleare; Professor Rona

Moss- and Professor Hotopf.

Professor 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 Spencer, CEO of the charity Action for ME, is

to speak in Session Three (to be chaired by Professor

Mansel Aylward, formerly Chief Medical Adviser to the

DWP and now funded by the notorious medical

insurance company UNUM). Another speaker is

Professor Dowrick from Liverpool, who, with

Rona Moss- 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

provides 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 so wrong.

There can be no doubt that NICE ignored the

international evidence that ME/CFS is a biomedical,

not psychiatric, disorder, claiming that 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 a Guideline is obligatory throughout the NHS

(and hence for affiliated agencies such as the

Department for Work and Pensions and Social

Services).

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; the 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 have been illusory ( see: "

Inadequacy of the York (2005) Systematic Review of

the CFS/ME Medical Evidence Base " by Malcolm

Hooper & Horace Reid at

http://www.meactionuk.org.uk/FINAL_on_NICE_for_Gibson.html

) but, 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

even life-threatening danger to people with ME/CFS -

see below.

The proscribing by NICE of testing for Vitamin D

status in patients with ME/CFS

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 to

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 truth.

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

ph Mercola 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 mushroom), 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 body 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-supplementation 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 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 that 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 ring and was

developed to protect petroleum from oxidative

gumming, whilst 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 been 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 in

the kidney to its active form of 1,25 dihydroxyvitamin

D (1,25(OH)2D, 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 prescribed).

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 1.4.7.2).

Quite how cognitive behavioural therapy and graded

exercise can raise deficient levels of this vital and

life-saving hormone that are found 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 " . F Holick MD

PhD; NEJM 2007:357:266-281; see also " Ultraviolet

B and blood pressure " . Rolfdieter Krause,

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 " . s et al. Arch

Intern Med: 2007:167:1159-1165).

Vitamin D is an essential part of the endocrine

system (which is well-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 B

Grant PhD of the Sunlight, Nutrition and Health

Research Centre, one of the top vitamin D

researchers).

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

arthritis and diabetes (see " Vitamin D Deficiency " .

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 ME/CFS 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 protein expressed primarily in neuronal cells

(MAP2). Initial studies with immunohistochemistry

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), which 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,

, 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 headache " .

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

Buchwald); 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

( ) now seems to regard ME/CFS as

maladaptive interoceptive signal recognition.

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 s Cancer Centre at the

University of California found that some 600,000

cases of breast and colorectal cancer could be

prevented each year, if only vitamin D3 levels were

increased.

Quite apart from being implicated in pancreatic

cancer, low vitamin D 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 which destroy the cell wall of viruses and

bacteria (see www.mercola.com; see also " Vitamin D

Deficiency " . 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.

Conclusion

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 Weir, whose details are

on the Co-Cure UK Good Doctor List

(http://www.co-cure.org/Good-Doc.htm ). Dr Weir

works part-time 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 ME/CFS patients.

The Doctors' Laboratory (55 Wimpole Street, London

W1G 8YL, telephone 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 post 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

supplement.

A more efficient way of increasing vitamin D levels

may be by using a 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 costs £225.

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 NHS.

The NICE Guideline on *CFS/ME*, however, may

prove to be a barrier impossible to surmount.