A NICE Conundrum?

Margaret Williams 30th December 2008


"A NICE conundrum seems to have presented itself, which the Judge in the Judicial Review of the NICE Clinical Guideline on “CFS/ME” may require NICE to explain for the benefit of straight-thinking folk who cannot readily understand such brain-teasers.

Straight-thinking folk know that NICE is funded by the UK Department of Health.

These straight-thinking folk also know that the NICE Guideline on “CFS/ME” (CG53) recommended as the primary intervention only behaviour modification, together with incremental aerobic exercise (cognitive behavioural therapy / CBT and graded exercise therapy / GET) for a disorder that NICE’s own paymaster accepts is a neurological disease, this having been confirmed once again in Hansard by the Parliamentary Under-Secretary of State, Department of Health, Lord Darzi, on 2nd June 2008.

It seems remarkable indeed that people unfortunate enough to be stricken with a neurological disease should not be permitted by NICE to be adequately investigated, but straight-thinking folk also know that NICE claims that its recommendations for CBT and GET in its Guideline are based on the very best evidence-base, which must surely re-assure these straight-thinking folk that they will be receiving the best possible management of their life-destroying disease.

But here’s the conundrum: NICE’s own paymaster (i.e. the Department of Health) is on record as stating – in writing – that it holds no evidence that the interventions recommended by NICE in CG53 actually work in restoring the return to work (this being the underlying purpose of the recommended management interventions).

This was revealed when the Department of Health was asked about the recommendations set out in the NHS Plus National Guideline – which the Department itself notably funded -- that was published in October 2006, (“Occupational Aspects of the Management of Chronic Fatigue Syndrome: A National Guideline” in which Wessely School members Professors Trudie Chalder, Peter White and Michael Sharpe were instrumental), the recommendations in that Guideline being the same recommendations that were adopted by NICE in its Guideline of August 2007.

Crucially, both Guidelines were based on the same “evidence-base”: of six Wessely School studies, three were co-authored by Trudie Chalder and one was co-authored by Peter White. In the NHS Plus Guideline, the Wessely School authors made inflated claims for the efficacy of CBT/GET in returning people with “CFS/ME” to gainful employment (“CBT and GET have been shown to be effective in restoring the ability to work”), but a US systematic review of the “evidence-base” had reported that “No specific interventions have been proved to be effective in restoring the ability to work” (SD Ross et al: Arch Intern Med 2004:164:1098-1107).

The key fact here is that the NHS Plus Guideline cited the Ross systematic review as its own evidence-base.

An inquiry was therefore made of the DoH how such divergent conclusions could be drawn from the same systematic review of the same publications --- one conclusion by Ross et al and the exactly opposite conclusion by the Wessely School. In the light of such an obvious dichotomy, the DoH was asked a simple and direct question: “Does the Department agree with the statement that cognitive behavioural therapy and graded exercise therapy have been shown to be effective in restoring the ability to work in those (with ME/CFS) who are currently absent from work?”

On 6th June 2008 the written response from the DoH was unequivocal: “The Department does not hold any data that support this claim”.
So here we have a situation in which the Department of Health (which funds NICE and which funded the NHS Plus Guideline) is on record as stating that it has no data to support the claims made by both the NICE Guideline and the NHS Plus Guideline.

If the Department itself holds no data showing that CBT/GET are in fact effective, where is this data? Does it actually exist, or is it merely a contrived “evidence-base” created by the Wessely School, whose vested interests in claiming its efficacy cannot be denied?

Regarding the obvious and serious conflicts of interest of the Wessely School in relation to the NHS Plus Guideline, on 23rd December 2008 a remarkable revelation was made – in writing – by Dr Ira Madan, Director of Clinical Standards, NHS Plus (who, with Wessely and Chalder, is based at Kings College): “The Department of Health have (sic) asked me to investigate your concern that one of the guideline development group members, Professor Trudie Chalder, and the two external assessors, Professor Michael Sharpe and Professor Peter White, had conflicts of interest whilst involved in the production of the guideline. I can confirm that I was aware of the potential for competing interests that you have stated. The roles that Professor White, Professor Sharpe and Professor Chalder have undertaken for the agencies and companies that you stipulate (i.e. the medical insurance industry) were in the public domain prior to the publication of the NHS Plus guideline. I am content, as the Director of that guideline, these potential competing interests did not in any way influence the synthesis of the evidence or the guideline recommendations”.

As straight-thinking folk will recall, the NHS Plus Guideline states “No conflicts of interest declared”, yet Dr Ira Madan is here acknowledging the existence of these Wessely School conflicts of interests, but stating that she is “content” about the situation, as people already knew about them.

In the Wessely School world of NHS Plus, two researchers were allowed to sit in judgment on their own publications, with the permission of Dr Ira Madan. They were not required to make conflict-of-interest declarations. This is not peer-review as the rest of the scientific world understands it.

Notably, the same people (Chalder, Sharpe and White) who were involved with the production of the NHS Plus Guideline (where they declared no conflict of interests) did declare and list very serious conflicts of interest in the MRC PACE trial documentation: "PDW has done voluntary and paid consultancy work for the Departments of Health and Work and Pensions and legal companies and a re-insurance company. MCS has done voluntary and paid consultancy work for government and for legal and insurance companies. TC has done consultancy work for insurance companies, is the author of Coping with Chronic Fatigue published by Sheldon Press and co-authors Overcoming Chronic Fatigue with Mary Burgess published by Constable and Robinson." (http://www.biomedcentral.com/1471-2377/7/6 ).

This is remarkably different from what the Department of Health confirmed in relation to the NHS Plus Guideline – in writing – on 20th November 2008: “I can confirm that the guideline contributors gave written confirmation that they had no conflicts of interest”.

What can explain such a marked discrepancy, and why should a statement have been published saying that no conflicts of interest exist when serious conflicts of interests are undoubtedly involved?

Not only do we now have written evidence that (i) the Department of Health holds no data that the recommendations in both the NHS Plus Guideline and in the NICE Guideline are in any way effective in restoring the ability of people with ME/CFS to return to work, and (ii) that two members of the DoH (William Scott and Dr Ira Madan) have made statements on the same issue that diametrically oppose each other, but we also have written evidence -- straight from Dr Madan at the Department of Health -- illustrating how the normal rules of independent peer review and conflicts of interest are regularly suspended when it comes to the “evidence-base” for CBT/GET in people with ME/CFS.

Consequently, as Dr Madan has stated that the Wessely School’s conflicts of interests did not make any material difference, she is now being requested to explain WHY the conflicts of interest she has acknowledged exist were not recorded as required, since conflicts of interest should be recorded to enable people to make up their own mind whether or not the conflicts matter. Such an important issue is not up to Dr Madan to decide but is –or should be -- determined by the AGREE Instrument.

Even though it is in the public interest to publicise that there is a potentially dangerous guideline in circulation that was engineered by Wessely School members whose conflicts of interest in respect of the medical insurance industry are legion (and who have no expertise in infection or in inflammation or in immunology that underpin ME/CFS), the Judge will not be considering the issues surrounding the NHS Plus Guideline

It is, however, hoped that the Judge will require the particular conundrum pertaining to NICE to be explained so that straight-thinking folk can understand it, namely, why NICE recommended interventions for “CFS/ME” for which its own paymaster (the Department of Health) has stated that there is no supportive data."

'I know nothing about bikes'

On Top Gear's Christmas special last night, an indignant Jeremy Clarkson insisted he didn't know anything about motorbikes when he was asked to drive one the length of Vietnam.

But ...........

"I know that ME exists ... I suffer from it twice a year, says G4 star Jonathan Ansell" ...

These are heady days for singer Jonathan Ansell. The 26-year-old is forging a successful solo career after making his name with the opera loving group G4 who sold 1.5million copies of their three albums in the UK.

And he will be spending the New Year with his fiancee, TV presenter Debbie King, whom he proposed to last month from the stage as he performed his show A Night At The Opera at the London Palladium.

However, as assured as his future may seem, two or three times a year Jonathan suffers what he calls physical breakdowns - the devastating result of chronic fatigue syndrome (CFS) also known as ME or myalgic encephalopathy - after he was struck down by glandular fever as a student.

And astonishingly, until this interview, he was unaware of the therapies available that can help sufferers......"

Oh Yeah, "therapies available that can help sufferers", where are they, on the MOON or hidden in The Thames ????

James May says that men are 'simple souls' ...

Good motoring, Vietnam! The watery tale of Top Gear trio's latest motoring challenge.

It was the ideal plan for a Top Gear special - Clarkson and Co racing through Vietnam in old bangers. Just one problem: they couldn't afford the cars. Presenter JAMES MAY tells us what happened next ...

Merry Christmas everybody, better health next year ...

Happy Birthday Earthrise

Forty years ago, the biggest TV audience in history tuned in to watch humankind's first close encounter with another world, as the crew of Apollo 8 reached lunar orbit.

Here, the Apollo historian and film-maker Dr Christopher Riley gives his perspective on the mission and how that Christmas Eve of 1968 changed the world ......

ME and CFS in the US and the UK

Margaret Williams

22nd December 2008

It is anticipated that the differences in the understanding of and the approach to ME/CFS in the UK as set out by NICE in its Clinical Guideline 53 on “CFS/ME” as compared with current biomedical research in the US will be brought to the attention of the Judge in the forthcoming Judicial Review on 11th and 12th February 2009 in the High Court in London.

Specifically, NICE failed to identify or define the disorder in question in that the Guideline Development Group (GDG) failed to differentiate ME from states of medically unexplained chronic fatigue and, importantly, advised against the very investigations that would do so.

NICE also rejected the use of the Canadian case definition, these being the criteria that distinguish ME/CFS from other states of medically unexplained chronic fatigue.

For almost two decades, the Wessely School has called the shots about “CFS/ME” in the UK and, despite the denials, it is believed that it is their influence at the Medical Research Council (MRC) that has resulted in the MRC’s categorisation of “CFS/ME” as a mental disorder and in the MRC’s repeated refusal of funding for biomedical research. It is the case that, since 2002, approximately 91% of the MRC’s total grant spend on “CFS/ME” has gone on Wessely School trials of behavioural interventions and the MRC has refused no less than 33 biomedical grant applications for ME/CFS.

The approach in the US is radically different.

Recruitment is currently taking place for participants in clinical trials that will look for specific sets of proteins in the cerebrospinal fluid (CSF) of ME/CFS patients. The study sponsors are Georgetown University / National Institute of Environmental Health Services (NIEHS) http://tinyurl.com/8k4nfq

The investigators have already shown (in a previous similar study) significant changes in proteins in the CSF which the investigators believe may be due to the fundamental pathology of ME/CFS.

The official title of the study is “Study Looking for Unique Set of Proteins in Cerebrospinal Fluid, which are believed to be found in Chronic Fatigue Syndrome Participants but not in Healthy Controls”. The investigators believe that these proteins (which are not seen in other disorders or in healthy controls) may identify the disease and define its mechanism.

The investigators note that increased cerebrospinal fluid pressure may be related to symptoms including headache, sleep problems, light-headedness, increased pain, excessive fatigue with even minimal work, and memory problems.

The detailed description states: “Neurological dysfunction is a key component of the clinical expression and case designation of (ME)CFS. If the central nervous system is involved, then evidence will be present in the cerebrospinal fluid.

Distinct patterns of proteins will be present in (ME)CFS compared to health control subjects.
Other testing would include assessment of lung capacity and scoring of shortness of breathing testing (pulmonary function testing / PFT)”.

Secondary outcome measures will look at differences in blood tests; at differences in blood pressure and heart rate in response to exercise, and at sensory nerve testing to determine the role(s) of altered nerve and brain function in ME/CFS. Skin tests for allergy will also be carried out.

The study is comprehensively placed in numerous topic categories which include gastrointestinal diseases, musculoskeletal diseases, neuromuscular diseases, multiple chemical sensitivity, central nervous system diseases, rheumatic diseases, myalgic encephalomyelitis, and virus diseases.
Additional relevant MeSH terms are listed as pathological processes / immune system diseases and Environmental Illness.

In the UK, the NICE Guideline which forbids such investigations will become legally enforceable in 2009.

Professor BASS, is this a taxi with a somatoform disorder ???

A NICE DILEMMA?

Margaret Williams 15th December 2008

"ME/CFS in the US

In the Summer 2008 issue of The CFIDS Chronicle published by The CFIDS Association of America, Anthony Komaroff, Professor of Medicine at Harvard, editor-in-chief of Harvard Health Publications and senior physician at Brigham and Womens’ Hospital, Boston (who has published more than 230 research papers on ME/CFS) wrote an article listing the top ten biomedical research findings in ME/CFS.

These are summarised at http://www.prohealth.com/library/showarticle.cfm?libid=14063 and include evidence that:

(1) many patients with ME/CFS have no diagnosable psychiatric disorder and that ME/CFS is not a form of depression;

(2) there is a state of chronic, low-grade immune activation, with evidence of activated T cells and evidence of genes reflecting immune activation, as well as evidence of increased levels of cytokines;

(3) there is substantial evidence of poorly-functioning NK cells (white blood cells that are important in fighting viral infections);

(4) there is evidence of white and grey matter abnormalities in the brain;

(5) there is evidence of abnormalities in brain metabolism (and evidence of dysfunction of energy metabolism in the mitochondria);

(6) there is evidence of abnormalities in the neuroendocrine system, particularly in the HPA axis but also in the hypothalamic-prolactin axis and in the hypothalamic-growth hormone axis;

(7) there is evidence of cognitive difficulties, especially with information processing, memory and/or attention;

(8) there is evidence of abnormalities in the autonomic nervous system (including a failure to maintain blood pressure, abnormal responses of the heart rate, and unusual pooling of blood in the legs, as well as low levels of blood volume);

(9) there is evidence of disordered gene expression, especially in those genes that are important in energy metabolism and in genes connected to HPA axis activity, to the sympathetic nervous system and to the immune system;

(10) there is evidence of frequent infection with viruses, especially herpesvirus and enteroviruses."


"CBT/GET does not prevent death from ME/CFS:

There have been a number of high profile deaths from ME/CFS in the UK. There can be few in the international ME community who have forgotten the harrowing death three years ago of 32 year old Sophia Mirza, who was forcibly but illegally detained under the Mental Health Act and who subsequently died from ME/CFS and whose autopsy revealed severe inflammation of the dorsal roots in her spinal cord. These are the sensory nerve roots, so she must have been in considerable pain for many years."


"If CBT is so successful, where, then, was the involvement of the Wessely School psychiatrists, especially Professors Simon Wessely and Peter White, and even Professor Bass himself, in these tragic cases? Peter White is on record as affirming that CBT/GET can cure “CFS/ME” (“Is full recovery possible after CBT for CFS?”; Hans Knoop, Peter White et al; Psychotherapy & Psychosomatics 2007:76:171-176).

Professor Michael Sharpe is also on record as asserting: “There is evidence that psychiatric treatment can reduce disability in CFS. In some cases, it can be curative” (“Psychiatric Management of Post Viral Fatigue Syndrome”; Michael Sharpe; British Medical Bulletin 1991:47:4:989-1005) and Simon Wessely himself is also on record as confirming that significantly more patients met the criteria for full recovery and that: “seven (23%) of the CBT patients were deemed completely recovered” (“Long-term outcome of cognitive behavioural therapy versus relaxation therapy for chronic fatigue syndrome: a five-year follow up study”; Deale A, Chalder T, Wessely S et al; Am J Psychiat 2001:158:2038-2042).

For the record, that same year (2001) Wessely is also on record as stating that CBT is not “remotely curative” (Editorial; JAMA 19th September 2001:286:11). Wessely does not clarify how the same intervention can result in complete recovery even though it is not remotely curative.

None of these trials, of course, included anyone who was severely affected by ME/CFS; indeed, it is entirely possible that there was not a single patient with ME/CFS in any of those studies, since most of the trials used the Oxford criteria and those criteria expressly exclude people with neurological disorders but do specifically include those with psychiatric disorders (which often have “fatigue” as a problematic symptom)............."

My addition: Oh and what do the brilliant people from Nijmegen say: they cure 70% of so called people with CFS or ME as they say that CFS and ME are the same ............

Yes, CBT is just magical, if only they would do a trial for once with ME patients so we could bin CBT once and for all .......

Always wondered what CBT psychiatrists really do ???

Martin Niemoller's poem ...

By Martin Niemoller, adapted by ME/CFS/FM/MCS Support for Tropical North Qld.

When the Nazis came for the communists,
I remained silent;
I was not a communist.

When they locked up the social democrats,
I remained silent;
I was not a social democrat.

When they came for the trade unionists,
I did not speak out;
I was not a trade unionist.

When they came for the Jews,
I did not speak out;
I was not a Jew.

When they came for the Incurably sick,
I did not speak out;
I was not Incurably sick.

When they came for me,
there was no one left to speak out.

≈≈≈≈≈≈≈≈≈≈

Martin Niemoller, German Protestant Pastor, 1892-1984

Your computer thinks you are an idiot !!!

A brand new book of cartoons by Randy Glasbergen which is more effective and less expensive than silly CBT !!!!!!!

CBT: Cameraman Beats The-rain ...

Professor Wessely, is this cameraman car-azy ???

Mother is arrested on suspicion of the murder of her daughter with very severe ME ...

A policeman's wife has been arrested on suspicion of the mercy-killing murder of the couple's seriously ill daughter.

Detectives are now examining the exact circumstances of the death of 31-year-old Lynn Gilderdale, who died at her home in Stonegate, in East Sussex, on Thursday.

Lynn was diagnosed with ME, once dubbed yuppie flu, in May 1992.

She spent much of her life unable to leave her bed, communicating with her family through sign language.

She could not bear any light, touch or noise and could hear only one whispered voice at a time.

"She is stuck in that room, not dead, but not alive properly".

There is no known cure for ME and ... ...........

PS 11.12.2008: Someone kindly pointed out to me that I might have misunderstood the article and that the mother might have taken her daughter’s life without her instructions. So I have changed the heading yesterday.

CBT your bike and it ends up like this ...

Even cars need protection against Continuously Baloney Telling psychiatrists ...

Professor White, can you help these people in your FINE PACE Trial ???

Perverting the course of science ...

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We all have an image in our minds of the role of scientists in Nazi Germany: sinister, lab-coated figures who spent half their time conducting gruesome – and largely pointless – experiments on concentration‑camp inmates to gratify their own cruel impulses, and the other half devising futuristic weapons of mass destruction for Hitler to hurl at the advancing Allies in a last attempt to stave off defeat.

Yet once you dig a little deeper, what is so disturbing is how prosaic the reality was, how similar in form, if not content, their work was to the research of today .................

Dogs are smarter than ...