FOR UK PARLIAMENTARY INQUIRY INTO ME/CFS

Chronological list of documents relevant to the Inquiry authored by

Professor Malcolm Hooper, Eileen Marshall and Margaret Williams

7^th November 2005

Most of the articles mentioned in this document are on the internet; all are available from Malcolm Hooper, Emeritus Professor of Medicinal Chemistry, Department of Life Sciences, University of Sunderland, SR2 7EE, UK.

Note that Myalgic Encephalomyelitis (ME) is listed in the World Health Organisation International Classification of Diseases also as chronic fatigue syndrome (CFS) and as PostViral Fatigue Syndrome (PVFS).  In the US, the disorder is sometimes known as Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS), whilst the current preference by some international researchers is for the term Neuro-endocrine-immune Dysfunction Syndrome (NDS), which they maintain more accurately reflects the underlying pathology.  It is important to be aware that this disorder is not, as claimed by some psychiatrists, synonymous with chronic unexplained fatigue (to which these psychiatrists unhelpfully refer as “CFS”).

Introduction

Our views are already on record in a preliminary submission of 18^th August 2005 prepared for this Inquiry (ME: Why No Accountability? A synopsis for the UK Parliamentary Inquiry), but this short introduction will hopefully emphasise the seriousness of the problem.

We submit that, for almost two decades, the beliefs and actions of a small but influential group of UK clinicians and researchers from the discipline of psychiatry have been responsible for not only a hindering of progress in the understanding of the biomedical disorder myalgic encephalomyelitis (ME) and for the consequent lack of appropriate NHS provision of services for sufferers, but also for the psychiatric bias that, since 1987, has pervaded the UK medical literature concerning this disorder.

We note that since psychiatry became fashionable, almost all conditions for which no specific cause was instantly apparent have, in the first instance, been labelled “psychiatric”, but that following scientific research, virtually all those conditions proved to be organic in nature.  The pontifications of the psychiatrists at the time are still extant and now make amusing reading, but presumably the unfortunate sufferers themselves were unamused.  Since such scenarios have occurred so frequently, one would imagine that by now, caution in diagnosis would be automatic until scientific research had been exhaustively pursued, but in the case of ME, the opposite has occurred: appropriate research into ME has been made almost impossible in the UK, with researchers other than psychiatrists being starved of funds; clinics that specialised in authentic ME have been closed and NHS consultant contracts not renewed, and the results of biomedical research from abroad have been ridiculed and rejected. 

Due to the relentless efforts of psychiatrists whose vested interests have now been exposed, the view has gained credence that it is acceptable to regard those with ME who are not willing to receive a psychiatric diagnosis as being “undeserving of treatment” (quoted from a lecture given in October 1999 at Strathclyde University by Professor Michael Sharpe [see below], who then disingenuously asserted that such a view is deplorable and that he was merely paraphrasing Bernard Shaw’s ‘Pygmalion’).  So that Parliamentary Inquiry Members may judge for themselves, Sharpe’s actual words were: “Purchasers and Health Care providers with hard pressed budgets are understandably reluctant to spend money on patients who are not going to die and for whom there is controversy about the “reality” of their condition.  They are in this sense undeserving of treatment. Those who cannot be fitted into a scheme of objective bodily illness yet refuse to be placed into and accept the stigma of mental illness remain – to paraphrase Bernard Shaw -- the undeserving sick of our society and our health service”.

We submit that these psychiatrists have been responsible for the promotion of a potentially damaging psychiatric management regime of cognitive behavioural therapy (CBT) that includes a programme of graded exercise, CBT being described in the “independent” report to the UK Chief Medical Officer of January 2002 as “a tool for constructively modifying attitude and behaviour” (Report Summary, Annexe 6, page 8). 

Evidence exists that shows CBT is at best ineffective and at worst harmful in authentic ME, resulting in severe relapse that may be lifelong.

Attention is drawn to the current issue of PULSE, 29^th October 2005, pages 14-15, which highlights the death of a 46 year old woman from Cardiff who died at a supervised gym following a GP referral. The medical defence organisations have repeatedly warned doctors that exercise programmes must be prescribed with the same degree of care as drug prescriptions and the item in PULSE noted that a study in the Journal of Public Health found that a small minority of GPs were responsible for the vast majority of exercise referrals; it noted that legal concerns are once again in the news, and that many GPs were reluctant to make referrals because of the lack of evidence and concerns over medico-legal responsibility.

The group of psychiatrists and supporters involved has become colloquially known as the “Wessely School” (see Hansard [Lords]: 19^th December 1998:1013), so named after psychiatrist Professor Simon Wessely from King’s College Hospital and The Institute of Psychiatry, London, whose published personal views on the non-existence of ME are prolific.  Other prominent members of the Wessely School include psychiatrists Professor Peter White from St Bartholomew’s Hospital, London and Professor Michael Sharpe, formerly of Oxford but now at Edinburgh: their involvement, as that of their like-minded colleagues, is documented in the literature listed below, most notably their long-term close association with the medical insurance industry.

The influence of this group of psychiatrists is extensive throughout UK Government Departments, the NHS and even the Judiciary: one severely affected litigant in a High Court action was informed that “Judges regard ME as self-indulgence”.

In 1999, the Countess of Mar, a stalwart campaigner for the UK ME community, obtained the Opinion of a Leading Queen’s Counsel in the House of Lords; the eminent QC’s Opinion stated:

“On the document you have sent me there is an overwhelming case for the setting up of an immediate independent investigation as to whether the nature, cause and treatment of ME as considered by the Wessely School is acceptable or consistent with good and safe medical practice.  There is substantial doubt as to whether such could be the case.  A formal request should be made to set up such an enquiry at which interested parties could be represented by Counsel”.

Attempts to do so have been unsuccessful until the present good auspices of Dr Ian Gibson MP (former Chairman of the Commons Science and Technology Select Committee and former Dean of Biology at the University of East Anglia) have made it possible, to whom the UK ME community owes considerable gratitude.

We ourselves submitted 92 pages of accurate references published in reputable medical and scientific international journals that provided convincing evidence of the organic and serious multi-system nature of the disorder to both the Chief Medical Officer’s Working Group and to the Medical Research Council during their respective deliberations on the direction of future research into what they both refer to as “CFS/ME”.  The reason this term is used was explained by Wessely himself: “It may seem that adopting the lay label (of ME) reinforces the perceived disability.  A compromise strategy is ‘constructive labelling’: it would mean treating chronic fatigue syndrome as a legitimate illness while gradually expanding understanding of the condition to incorporate the psychological and social dimensions.  The recent adoption by the UK Medical Research Council and the chief medical officer’s report of the term CFS/ME reflects such a compromise”  (BMJ: 2003:326:595-597).

For ease of reference, the papers were broadly divided into sections that included historical papers on ME (1938-1980); general papers on ME (ie. papers that addressed multi-system anomalies, for example the evidence of impaired oxygen delivery to muscle and evidence of delayed recovery from fatiguing exercise, as well as balance and visual problems); laboratory findings in ME; quality of life in ME; chronicity and severity in ME; precipitating factors in ME; epidemiology of ME; neuroendocrine abnormalities in ME; neurological abnormalities in ME; evidence of demyelination in ME; ocular problems in ME; virology in ME; overlap of ME with Post-Polio Syndrome; chemical injury to the blood brain barrier; immunology in ME (including evidence of hair loss and mouth ulcers in ME); allergies and hypersensitivities in ME; anaesthesia problems in ME; vascular problems in ME; cardiac problems in ME; respiratory problems in ME, gut dysfunction in ME; liver and pancreatic involvement in ME; brain imaging anomalies seen in ME; cognitive dysfunction in ME; gynaecological problems in ME; special problems in children with ME, and the similarities and differences between ME and fibromyalgia.

On each occasion, our submissions were comprehensively ignored by the Government bodies concerned.

Some of our documented concerns and supportive evidence were also passed by the Countess of Mar to appropriate government officers for presentation to the Chief Medical Officer and to the Director of the Benefits Agency Medical Services, with a request by Lady Mar for a detailed response.  The answer came in a written response from an MP: it had been decided at Ministerial level that our evidence should be ignored and that no action be taken.

The documents listed below provide a paper-trail record of our concerns that the increasing incidence and prevalence (and even the very existence) of a serious neuro-immuno-vascular disorder are being denied by UK Government bodies due to the malign influence of Wessely School psychiatrists.

1994

The Views of Dr Simon Wessely on M.E.: Scientific Misconduct in the Selection and Presentation of Available Evidence?

Eileen Marshall and Margaret Williams

The CFIDS Chronicle: Spring 1994:14-18

The article provided direct quotations from Wessely’s published work on ME/CFS, including several for which he has become notorious, for example, that ME exists only because of patients’ ‘maladaptive coping strategies’; that ME is simply one end of a continuum of ‘tiredness’; that it is nothing more than an attitude problem experienced by suggestible people who see ME as an easy escape route from life’s problems; that ‘a little more psychology and a little less T cells (ie. immunology) would be welcome’; that any observed abnormality of muscle function may result from physical inactivity; that on examination of those with ME, “the usual findings of simulated weakness were present”; that those with ME exhibit “learned helplessness”; that “the description given by a leading gastro-enterologist at the Mayo clinic remains accurate: ‘the average doctor will see that they are neurotic and he will often be disgusted with them’ ”.

Note:  Simon Wessely personally threatened the UK distributors of The CFIDS Chronicle with an injunction unless they promised to deface every copy and remove our article before distributing the Spring issue in the UK; Wessely’s threats were acted upon, but copies that came direct from the US were not defaced.  People in the UK were outraged that copies for which they had paid in advance had been defaced even without an injunction.

Letters to the Editor:  Simon Wessely Follow-up

Eileen Marshall   Margaret Williams

The CFIDS Chronicle: Summer 1994: 77-79

Our reply to Wessely’s response pointed out that, contrary to what he stated  (“I run the only free service solely dedicated to the needs of patients with CFS/ME between the River Thames and the Coast”), in the UK there is a National Health Service and that this means that all patients can receive free treatment, and that there were at the time numerous other NHS Consultants who ran clinics south of the River Thames specifically for ME patients. We also pointed out that, contrary to his claims, he was not “principal expert witness in two medico-legal cases concerning CFS” but was in fact one of three medical expert witnesses in both cases.  We also noted that, since Wessely asserts that he does not recognise ME as a distinct entity but includes all people with chronic fatigue under the single label of CFS, his claim that “research has shown that our rehabilitation programmes are proving successful” needs to be questioned, because we have no idea about how many of his patients actually have ME.  We also noted that it is sadly true that Wessely has changed the facts about ME; that he has indeed misrepresented the valid findings of other researchers and that he does indeed ignore important findings that do not support his own views and, bearing this in mind, we felt justified in querying whether or not this amounted to scientific misconduct.

1995

UK Task Force Report: CFS/M.E. is Real

Eileen Marshall and Margaret Williams

The CFIDS Chronicle: Spring 1995: 22-23

This document summarised the UK National Task Force Report from Westcare, September 1994, pointing out that the Report was unequivocal in its conclusion that progress in understanding ME is hampered by the use of heterogeneous study groups and definitions of “CFS”, by the lack of standardised laboratory tests, and by the invalid comparison of contradictory research findings stemming from these factors.

1996

Conference Report: Transcript of Lecture given on 23^rd November 1995 at the Coventry and Warwickshire Post-Graduate Centre by Professor Peter Behan.

Margaret Williams (using the pseudonym Julia Hamilton)

InterAction No.21: Summer 1996

This document notes that Professor Behan stated that although the diagnosis remains essentially one of exclusion, there are now laboratory techniques that will confirm the diagnosis; that the acute fatigue is exactly the same as that seen in conditions such as multiple sclerosis; that by using refined techniques for measuring gait disturbance and by measuring muscle power, a phenomenal drop in maximum oxygen consumption is apparent; that there is very early excessive intracellular lactic acidosis with exercise and that this tends to persist; that patients with ME have reduced levels of acylcarnitine (carnitine being an amino acid used in mitochondrial oxidation); that there is abnormal liver function; that there is abnormal immune function in ME; that there is a central cellular deficit giving rise to other abnormalities and that ME is an organic illness.  The document noted that Professor Behan made sure that the audience was left in no doubt about his view of those psychiatrists, often powerful, who have brought to patients with ME what Behan termed ‘enormous trouble’.

Denigration by Design?  A Review, with References, of the Role of Dr Simon Wessely in the Perception of Myalgic Encephalomyelitis 1987-1996.  Volume I   pp 217. 

Eileen Marshall    Margaret Williams     August 1996

This compendium considered the various terminologies for the disorder; definition difficulties; Wessely’s tactics of dismissal and his relentless denial of the evidence of organic disorder; illustrations of research findings and opinions with which Wessely disagrees; extensive quotations from Wessely’s

published work (so there can be no denial of his views on ME/CFS); Wessely’s obvious lack of balance; questions that Wessely might usefully be required to answer, such as where is his evidence  to support his assertions that those with ME obtain “secondary gain” by “adopting the sick role”, and a review of the losses sustained by those with ME that Wessely never once addresses or even mentions.

Note that the document included a mini-review of some of the published works on ME/CFS by Dr Anthony David (a frequent co-author with Wessely), famous for his beliefs about ME that include: “A diagnosis of depressive illness would be appropriate.  Unfortunately, this is not good enough for the patient”; “self-help organisations have established ‘ME’ in the minds of the public”;  “doctor behaviour, such as sick certification, emerged as a significant contributor to the risk of chronic fatigue” and  “clinicians should avoid reinforcing unproven illness beliefs”.

Observations on the Joint Report of the UK Royal Colleges of Physicians, Psychiatrists and General Practitioners on Chronic Fatigue Syndrome, CR54, October 1996.

Eileen Marshall     Margaret Williams     17^th November 1996

This document exposed the psychiatric bias that pervaded the Report and provided illustrations of how research evidence had been manipulated by the Report’s authors to look as if it supported their own views when the cited references did not support them at all.  In the Joint Royal College’s Report, Wessely et al specifically state the following:  ‘ME’ does not exist; patients wish to keep the term ‘ME’ because only with that label are they eligible to call upon the welfare state for help; the dysfunctional beliefs of CFS/ME patients have an important place as an obstacle to recovery; CFS/ME is a somatisation (psychiatric) disorder; no investigations should be performed to confirm the diagnosis; there is no convincing evidence of any change in muscle structure or function other than those secondary to inactivity; immunological abnormalities “should not deflect the clinician from the endorsed (psychiatric) approach and should not focus attention towards a search for an ‘organic’ cause”; there is no compelling evidence linking immune dysfunction with disability; there is no reason for the creation of specialist units; specific guidelines for the management of ME should not be issued to general practitioners; the need for future research is regarded as unnecessary;  complementary therapy is discouraged but antidepressants should be prescribed for those with “CFS” even in the absence of depression (advice that would seem to reflect HealthWatch policy --see below).

1997

Comparison of the American Report for Physicians on CFS (September 1996) with the UK Joint Royal Colleges’ Report on CFS (October 1996)

Eileen Marshall    Margaret Williams     20^th February 1997

This document highlighted the difference in approaches to the management of ME in the UK and the US, for example the US Report stated it is important to note that up to 40% of carefully evaluated patients do not have psychiatric illness; that patients should be treated with compassion; that there is a greatly increased incidence of allergies; that there should be a reasonable laboratory workup; that patients should be referred to professionals who can help with applying for disability benefits and that patients benefit from participation in support groups; that the disorder is a multisystem illness with prominent central nervous system (CNS) involvement and that in the case of children, the physician should work with the school to limit class time and that home tutoring may be an alternative.  In stark contrast, the UK Joint Royal Colleges’ Report stated that children may need to be forcibly removed from their homes and parents and that there should be an immediate return to school; that nothing but the most basic screening tests should be carried out; that involvement with a support group is a predictor of poor outcome; that 75% of CFS patients have psychiatric illness; that patients with allergies may fulfil criteria for somatisation disorder; it concluded that chronicity is likely to be associated with unaddressed psychosocial issues.

1999

Denigration by Design?   A Review, with References, of Dr (now Professor) Simon Wessely in the Perception of Myalgic Encephalomyelitis.  UP-DATE: 1996-1999    Volume II  pp 271

Margaret Williams     November 1999

Like the first volume in 1996, this compilation provided further illustrations of international research evidence on ME/CFS that Wessely School psychiatrists dismiss, trivialise or ignore, together with accurate quotations from their own published work.  It included a section illustrating psychiatrists’ track record of mis-attribution and considered areas where Wessely has clearly been shown to be wrong, for example, the Camelford catastrophy, in which 20 tonnes of aluminium sulphate were accidentally pumped into the drinking water supply in July 1988 at Camelford, in which residents and visitors suffered distressing symptoms such as nausea and vomiting, diarrhoea, skin rashes, musculoskeletal pains, with malaise and impairment of memory; in some cases hair, skin and nails turned blue; seven people died; 25,000 suffered serious health effects and 40,000 animals were affected, but which Wessely authoritatively dismissed as mass hysteria and anxiety (whereas other competent non-psychiatrist researchers found organic brain damage to have occurred).

The compilation considered 13 conclusions in relation to Wessely’s public pronouncements on ME, including his view that ME is a “myth” caused by patients’ belief that they are suffering from a disorder called ME.

The document also included a 20 page summary of some of the findings presented at the Second World Congress on Chronic Fatigue Syndrome and Related Disorders held in Brussels, 9-12^th September 1999, in which evidence was presented on the biochemical and microbiological aspects of the disorder, as well as on the disrupted immunology and on the epidemiology; specifically, it was noted that a total cardiovascular work-up reveals that frequently there are CNS vascular occlusions in ME and that vasculitic patterns are identical to those seen in HIV patients: SPECT and PET scans show that huge areas of the brain are injured.

2000

Consideration of Some Issues Relating to the Published Views of Psychiatrists of the ‘Wessely School’ in relation to their belief about the nature, cause and treatment of myalgic encephalomyelitis (ME)

Margaret Williams, with Appendices by Val Broke-Smith and Ann Crocker     March 2000

Because the two volumes of “Denigration by Design?” were so detailed, it was suggested that a condensed version be produced.  This document looked at the then current situation; at the evidence that psychiatrists of the Wessely School were wrong about ME, and at the tactics of dismissal used by those psychiatrists.  The document included an Appendix on “Special issues relating to the treatment of children and young people with ME/CFS: the perspective of parents” by Val Broke-Smith and an open letter to the Chief Medical Officer from Ann Crocker.  It also included a recommended reading list.

2001

Submission to the CMO’s Working Group on CFS/ME: matters of continuing concern

Margaret Williams      9^th March 2001

This 22 page fully referenced document was submitted to the CMO’s Working Group (WG) on behalf of the 25% ME Group for the Severely Disabled.  Its objective was to gain official recognition of the plight of those who do not fit the Oxford 1991 case definition of “chronic fatigue” drawn up by Wessely School psychiatrists upon which the CMO’s WG relied (ie. those with authentic ME as distinct from psychiatric fatigue), so that ME patients would no longer be excluded from NHS service provision.

The document briefly reviewed the history and symptomatology of ME and noted the physical signs found in ME and it noted the detrimental effect of the term “CFS” caused by its focus on one single symptom, namely “chronic fatigue”.

More importantly, because the key players in the CMO’s WG were of the belief that subgrouping of the heterogeneous label “CFS” was simply a matter of “semantics”, the document provided compelling evidence from international experts of the need for careful subgrouping.

Because the drafts of the CMO’s WG Report seemed to totally ignore the available evidence of serious organic pathology in ME/CFS, the document also provided summaries of some of the findings presented at the AACFS Conference in Seattle in January 2001, including evidence of abnormalities seen on brain studies, abnormal neurological findings, visual processing disabilities, biochemical abnormalities, recent virological findings, recent microbiology findings, immunology studies (including evidence of autoimmunity in ME/CFS) and evidence of gene abnormalities, in particular, evidence of prominent RNA not observed in normal controls. Significantly, the prominent RNA bands sequenced showed homology with human genes that are noted for their tendency for gene rearrangement under severe physiologic stress.

The document noted that the practice of medicine ought not to be a pitched battle between patients and their clinicians, and that such a situation might have arisen because for the most part, patients with severe ME are far better informed about their condition than their doctors.

The document was entirely ignored.

Concerns about the forthcoming UK Chief Medical Officer’s Report on ME/CFS, notably the intention to advise clinicians that only limited investigations are necessary

Sally Montague     Malcolm Hooper     30^th July 2001

Because this document placed in the public domain facts that certain members of the CMO’s WG apparently would have preferred not to be in the public domain, it caused an outcry from some of the doctors who were acting as Government advisers on the Working Group but who had not declared their competing interests.  Of significance was the nature of those undeclared interests: both Professor Simon Wessely and the Medical Adviser to the ME Association (Dr Charles Shepherd) were members of an organisation called HealthWatch (which used to be called The Campaign Against Health Fraud), known for its zealous views which are antagonistic towards alternative and complementary medicine and towards those who believe in environmental and chemically-induced illness, including multiple chemical sensitivity (a well-documented component of authentic ME).  It is a campaigning organisation that has in the past accepted money from both the health insurance industry and the pharmaceutical industry.  The campaign’s own literature states that its aims are to oppose unnecessary treatment for non-existent diseases.  Simon Wessely is on record as affirming that ME is a non-existent disease, and between February and April 2002 was involved with a poll of “non-diseases” run amongst doctors by the British Medical Journal: the poll found ME -- along with big ears and freckles -- to be a non-disease that is best left medically untreated. Wessely is listed in HealthWatch documents as a “leading member of the campaign”.  The Medical Adviser to the ME Association admits to being an active member.  Given that the stated remit of the CMO’s Working Group was to consider all treatment and management options for CFS/ME, for such key figures to be members of an organisation whose members are so strongly opposed to complementary approaches (known to be helpful in ME) seemed a cause for concern.

Also a matter for concern was Wessely’s close involvement with PRISMA, a multi-national healthcare company working with medical insurance companies; it arranges “rehabilitation” programmes for those with “CFS” and places heavy emphasis on training sufferers to “regain a normal life again”.  It claims to have developed a “unique treatment programme” for “hopeless” cases (in which it specifically includes “CFS”).  In the PRISMA Company Information, Simon Wessely is listed as a Corporate Officer: he is a member of the Supervisory Board, and in order of seniority he is higher than the Board of Management.  It was a cause for concern that his favoured regime of CBT was underpinning every aspect of the draft versions of the Report, so we asked if it was possible that Wessely was recommending to the CMO a management regime for “CFS” that is known to be harmful for those with authentic ME but which is provided by a company of whose Supervisory Board Wessely is a member?

The authors of the document were fiercely attacked for using the pseudonym “Sally Montague”, even though no deceit had taken place because the document was never intended for submission to a journal and even though it was explained that “Sally Montague” was a composite name encompassing six different people, including researchers, medical scientists and clinicians, some of whom had a life-time’s experience of ME, but who for professional and personal reasons did not wish to reveal their identity, not least because some were themselves severely affected by ME and were too ill to cope with any publicity or media intrusion.

The document contained 89 references, many of which supported our view that investigation is the only way forward towards understanding such a complex disorder as ME, and it set out our concerns about the way the draft versions of the CMO’s report continued to ignore the reality and nature of ME/CFS and to assert that only the most basic screening should be carried out for those with ME/CFS.  Because of this, the document provided evidence of investigations that international experts in the disorder deemed essential. These included immunological testing; virological screening; endocrine testing; central, autonomic and peripheral nervous system testing; nuclear imaging; tests for vascular dysfunction; lung function testing; testing of exercise capacity; tests for cardiac anomalies; tests for liver dysfunction and ocular testing.

Because of the furore occasioned by the document, on 7^th July 2001 the authors released a Statement:

“All six people contributed to the Montague / Hooper paper which sets out their concerns about the forthcoming CMO’s report on CFS/ME.  The science described in our paper and the supporting references stand on their own and need no justification.  We believe that it is imperative that all the evidence available about CFS/ME is considered before the CMO’s final report is published. Official reports emanating from such a body will have far-reaching consequences which we believe might seriously jeopardise the health and well-being of ME sufferers and render their future prospects very bleak.  We strongly reject any attempt to label CFS/ME as a psychiatric disorder for which psychotherapy is the only recommended treatment.  It is a matter of personal regret for all of us that it has been necessary to challenge in this way the work of the CMO’s Working Group and its lack of transparency.  However, the failure of the CMO’s group to consider all the science and the inability for dissenting views to be accommodated leave us no option”.

(In the event the final Report, as the various drafts, asserted that only the most basic and routine tests were appropriate and that the management regime of choice was to be cognitive behavioural therapy with graded exercise).

Concepts of Accountability?

Sally Montague   Malcolm Hooper and associates     28^th August 2001

Due entirely to the explosion of harassment directed at Professor Hooper by certain medical members of the CMO’s Working Group and to the torrent of abusive letters to Hooper himself, including a lengthy series of letters to the Vice Chancellor of Hooper’s University demanding that he appear before a “disciplinary” hearing, not forgetting the correspondence from Professor Simon Wessely or the letters sent to Hooper from the Solicitor to HealthWatch, or the letter to Hooper from Nick Ross (of “Crimewatch” fame, who is also one of the founders of HealthWatch but who seemed unaware of what  the HealthWatch literature actually states in black and white), it was deemed sensible to compile a comprehensive document setting out the background to the writing of the Montague / Hooper paper. 

The document stated that those associated with the Montague / Hooper paper were concerned that UK patients will continue to be denied appropriate investigations if the advice of the “Wessely School” is unquestioningly accepted by the CMO’s Working Group.

The document amounted to 69 pages and contained 134 references.  Sections included information on HealthWatch and on its published views about ME: since the late 1980s HealthWatch has carried out a sustained and vicious attack on ME patients, most publicly and notably by its activists Caroline Richmond (a journalist and one of the founders of HealthWatch, known for her extreme animosity towards those with ME) and, even more vitriolically, by Dr Mike Fitzpatrick, a GP named as medical writer for HealthWatch, who also writes for the on-line publication “spiked”. Fitzpatrick is famed for his publications denigrating those with ME and for his public attack in 2002 on the CMO for taking ME seriously, claiming that the CMO’s stance was “ a surrender of medical authority to irrationality”.  The document also provided some of the antagonistic views of HealthWatch towards nutritional therapies (which have been found to be helpful in ME).  The document also noted the involvement of the Medical Adviser to the ME Association with HealthWatch activities against doctors who were deemed by HealthWatch activists to be acting against the best interests of the pharmaceutical industry.

Composite Response on the Final Draft Version of the CMO’s Report of 31^st August 2001

Edited by Malcolm Hooper     20^th September 2001

This fully referenced 39 page document was a last attempt to modify the intransigent views of the key players who dominated the CMO’s Working Group.  It addressed the assertions contained in the final draft of the Report which the international evidence had clearly shown to be untenable and it pointed out glaring and indefensible errors of fact.

The document was once again entirely ignored by those responsible for the CMO’s WG “independent” Report.

The 1996 Strasbourg Convention on Biomedicine and the Reform of the UK Mental Health Act: have they anything to do with the attempt to re-classify ME and CFS as mental illness in the WHO Guide to Mental Health in Primary Care?

Margaret Williams     September 2001

This document noted Wessely’s view that “Functional somatic syndromes (ie. psychiatric syndromes, in which he includes “CFS/ME”)  pose a major challenge to medicine and that they are associated with unnecessary expenditure of medical resources” and his view that such syndromes “urgently require improved management”.  Mindful of Wessely’s beliefs about compulsory “management” of ME/CFS, the document noted the proposed changes to a person’s right not to be experimented upon without their informed consent; in particular, that there are three groups of people for whom such consent will not in future be required:  those who are deemed to be mentally ill; those for whom no other known treatment is effective, and children.  It also noted that in certain situations, “general interests” will take priority over those of the individual.  It considered the proposals for reform of the UK Mental Health Act  (1983), which would give psychiatrists far greater powers to enforce compulsory psychiatric treatment upon both adults and children in that psychiatrists would be able to drug people (including children against the wishes of their parents) if they have “any disability or disorder of the mind or brain, whether permanent or temporary, which results in an impairment of mental functioning”, and the  document noted that this seemed a chillingly watertight definition.  The document questioned how such changes might relate to those with ME/CFS if Wessely et al were to be successful in re-classifying it from its present classification of neurological to a “mental” classification, and it included a quotation from a Ministerial response to this question.  The document also questioned whether “general interests” are already taking priority over those of the individual, and asked if those “general interests” are economically and commercially determined.

Comments on the Australasian Report on CFS

Margaret Williams  (compiled from various published critiques).   2^nd December 2001

“Wessely School” influence is not limited to the UK: it extends to Australasia, where Wessely has certainly lectured; see “Simon Wessely: Prophet or Profit” by Dr Ken Jolly, a New Zealand GP, published in ANZMES Meeting Place: Spring 1998: 56:10-12, where Jolly exposes what he refers to as “an alarming trend” by Wessely of diverting research into ME along blind paths; how this has affected sufferers’ accessibility to medical care and financial assistance and how Wessely’s influence has resulted in clinicians with opposing views being sidelined by his having convinced the authorities that ME patients do not have a physical illness. Jolly highlights what he calls Wessely’s “main mistake”, namely that Wessely concentrates only on “fatigue” and ignores all other symptoms, thereby distorting study results, noting that Wessely’s beliefs are misguided, but that Wessely may be unaware of the damage he is causing to sufferers. There is one particularly prominent psychiatrist in Australia and another in New Zealand who seem to display an identical closed mind to the international scientific evidence of organic pathology in ME/CFS and who seem to exhibit the same bias as shown by Wessely himself.  The Report of The Royal Australasian College of Physicians reflects this psychiatric bias.

Because the psychiatrists who dominated the CMO’s Working Group and the MRC CFS Research Advisory Group placed such heavy reliance upon the Australasian Report, it became necessary to compile a concise document containing published critiques by experts including Dr Abhijit Chaudhuri from Scotland; Dr Eleanor Stein from Canada; Dr Peter del Fante from Australia; Professor Peter Rowe from Johns Hopkins, Baltimore; Dr Lawrence Budd from Australia and Dr Nicole Phillips from Australia, all of whom cogently exposed the many shortcomings and undisputed psychiatric bias of the  Australian Report.

What is ME?  What is CFS?  Information for Clinicians and Lawyers

EP Marshall     M Williams    M Hooper        December 2001

This fully referenced document was published as a 26 page booklet and because of the demand, went through four print runs.   It looked at the history and classification of ME; it provided a description of ME; it documented the symptoms seen in ME and the evidence of abnormalities found in ME; it listed precipitating factors and the physical signs found in ME; it discussed the changing definitions in relation to the emergence of “CFS” in 1988, and at how “CFS” displaced ME in the UK.  It included a note of caution for lawyers and suggested that clinicians and lawyers need to come to their own conclusions about what might motivate a group of doctors (mostly psychiatrists) to disassemble a formally classified neurological disorder and endeavour to replace it by a much larger category of “behavioural” illness.

2002

Medical Research Council’s plans for research

Margaret Williams        18^th June 2002

Following the publication in January 2002 of the CMO’s Working Group Report on “CFS/ME” and the decision by the Chief Medical Officer to hand over responsibility for the direction of future research into “CFS/ME” to the Medical Research Council, a Briefing on the MRC’s strategy for advancing research into CFS/ME took place at the House of Commons, at which Dr Diana Dunstan of the MRC announced that a group of leading experts from various fields had been convened “who did not previously specialise in CFS/ME” because it was felt important to have “ a fresh and independent look” at the issue.

This document noted that it would seem to be erroneous for the MRC spokesperson Dr Diana Dunstan  to claim that members of the panel were “independent”  and “fresh” to the issue of ME/CFS and that it would seem to be deliberate misinformation, and thus misleading and untrue.  It was pointed out that at least two of the MRC Research Advisory Group (RAG) members were not at all “fresh” to the issue, because one of them (Professor Alan McGregor) had not only co-authored two papers on CFS with Wessely but was listed as a member of the Linbury Trust Advisory Panel on CFS that had been funding Wessely’s psychiatric studies on “CFS” since 1991; another (Professor Philip Cowan from the Psychopharmacology Research Unit at Oxford) was on record as holding strong views on the psychiatric nature of CFS and was co-author of a paper on CFS with Professor Michael Sharpe.  It was also noted that another member of the RAG was Professor Til Wykes (who, as Simon Wessely, is from The Institute of Psychiatry) who is on record as believing about CBT: “If you encourage them to do things, as part of a treatment called cognitive behavioural therapy, you do see improvement.  It’s a way of getting people to take control of their lives”.

The document asked why there was no neurologist and no vascular medicine specialist on the MRC panel of “experts”.

Following representations, the then Chief Executive of the MRC (Professor Sir George Radda CBE FRS) was compelled by letter dated 15^th July 2002 to concede Professor McGregor’s involvement with the Linbury Trust and the fact that he had previously co-authored papers on CFS with Wessely (which Radda inadequately tried to defend, saying “You cite papers from some years ago but he has not published further on CFS/ME”).  However, the letter also stated:  “Thank you for your suggestion about the need for a neurologist.  This fits with other comments we have received.  The Chairman of the group agrees this is a good idea and we are actively seeking a suitable person”.  The inclusion of a suitable neurologist ought surely to have been obligatory from the outset in a group that was supposed to be considering future research for a WHO-classified neurological disorder.

Over-view of the Alison Hunter Memorial Foundation ME/CFS Clinical and Scientific Meeting, December 2001, Sydney, Australia

Margaret Williams  (with grateful acknowledgement to Dr Rosamund Vallings and to Jan van Roijen)

15^th July 2002

This document summarised some of the presentations given at this international conference by world-renowned experts including Anthony Komaroff, Professor of Medicine at Harvard; Professor Kenny de Meirleir from Brussels; Professor Neil McGregor from Newcastle, New South Wales; Dr Dharam Ablashi from Colorado and Dr Susan Levine from New York, who variously presented evidence on the biology of ME/CFS; on gastrointestinal problems and gastric emptying studies; on ME and MS as subsets of a group of cellular immunity disorders; on active HHV6 infection and its correlation with RNaseL low molecular weight protein (37KDa) in ME patients; on the objective evidence of brain impairment; on disruption to regional cerebral blood flow; on the pathophysiological mechanisms in ME; on the biochemical anomalies found in ME; on food intolerance in ME and on channelopathy in ME.  Komaroff emphasised that some patients are completely disabled by ME and noted that their impairment, as measured by the SF-36 instrument, is comparable with that of patients with congestive heart failure. He said the evidence indicates an organic basis for the disorder.

Important paper which explains multiple chemical sensitivity (MCS). 

Reviewed by Margaret Williams     August 2002

This document reviews a seminal paper by Professor Marty Pall from the School of Molecular Biosciences at Washington State University published in the prestigious Journal of the Federation of American Societies for Experimental Biology in September 2002.

Pall’s paper presents a validated explanation for the biological basis of the specific symptom pattern found in MCS (including the ‘spreading phenomenon’) associated with chemical exposure and injury.  MCS is a known component of ME.  Sceptics, including psychiatrists, have been wont to scoff at MCS sufferers, claiming that “there is no known mechanism whereby low levels of chemicals of widely varied chemical structure can interact adversely with numerous organ systems”; thanks to Pall, such disbelief and dismissal will no longer be tenable.

Notes on current research in ME

Margaret Williams     November 2002

This document noted that the key feature of current ME research is one of compromised immune cells, with significant disturbance to various important pathways and it noted the work of three teams.

The team from the Vascular Diseases Research Unit at Dundee (Dr Vance Spence et al) have identified four major pathways that are deranged in ME: the pattern of results is specific to ME and the evidence points towards ME being a separate and distinct syndrome.  Many of the symptoms of ME can be explained by dysfunction of blood vessels, especially at the level of endothelial cells (the inner lining of blood vessels).  There is clear evidence of accelerated apoptosis (programmed cell death) of specific immune cells in ME patients.

Professor Kenny de Meirleir from Brussels presented a paper in Northern Ireland on 2^nd November 2002 in which he demonstrated that ME is a disorder of the immune system: he has found evidence of small fragments of specific RNaseL nucleotides (from the antiviral defence pathway) within the cells, causing chaos, with serious injury to the cell.  The damage caused by these fragments is not discernible on standard blood tests.  Such interference gives rise to disturbances in many pathways including oxidative stress, lipid peroxidation and cellular apoptosis, with consequences for the vascular endothelium.  This work ties in with the work of Spence et al.

Professor Mina Behan of Glasgow (now deceased) had found very swollen muscle cells in some patients with well-defined ME, the cells being disordered and dysfunctional, with clearly visible enlarged and thickened mitochondria.  This hypertrophy of the mitochondria is possibly the result of the cells’ continued efforts to get energy.

The document noted that given these known biomarkers of significant cell injury in ME, for the authors

of the CMO’s Report to advise that comprehensive testing is neither necessary nor appropriate for those with ME and for the Report to promote forced exercise regimes (with the assertion that psychotherapy is the only “evidence-based” form of management for ME) has once again been shown to defy scientific credibility.

Response to the MRC Research Advisory Group (RAG) Draft Document for Public Consultation on “CFS/ME” Research Strategy dated 17^th December 2002

M Hooper    EP Marshall    M Williams    27^th December 2002

This 26 page document containing 37 references was submitted to the MRC as part of the MRC’s “public consultation”.  It contained stringent refutations of the many misleading assertions contained in the RAG document, for example, the RAG document stated at paragraph 6:  “A strategy is proposed which reflects the current state of knowledge of CFS/ME”, which was demonstrably untrue because the RAG also stated (at paragraph 82) that “The MRC CFS/ME Research Advisory Group has not undertaken a detailed review of the current level of scientific knowledge of CFS/ME” and (at paragraph 102) stated “at no point has the literature been systematically reviewed”, so our document pointed out that this was surely essential if the RAG wished to produce a credible research strategy.  Another misleading assertion in the RAG document stated: “Clinical experience would indicate that most patients with CFS/ME have neurological signs that lie within the normal range”, so we drew attention to the fact that both the 1991 Oxford criteria for CFS and the 1994 CDC criteria for CFS expressly exclude patients who have any physical signs and that the 1994 criteria are unequivocal on this, stating:  “We dropped all physical signs”.  We asked what disorder the RAG was talking about as it could not be talking about ME, which is formally classified by the WHO as a neurological disorder.  The RAG consultation document went on to emphasise the effects of suggestibility on patients with CFS/ME and it also emphasised “personality factors”, which we pointed out seemed to expose the underlying agenda of the MRC, so we again disputed that the RAG was aware of the current state of the biomedical knowledge on ME/CFS and suggested that without such knowledge, it was not possible for the RAG to deliver any credible research strategy for ME/CFS.

In our document, we said: “The authors of the RAG draft document have ignored all the justified criticism of the information on which they place so much reliance; this is momentous, because that criticism revealed the misrepresentations, the misinterpretations, the denial of available credible evidence, the deception, the selectivity in use of the available evidence, the methodological flaws and the many omissions which pervade so much of the Wessely School literature.  Significantly, claims made by these psychiatrists are not established facts at all, nor are they supported in the international literature”.

We asked if there was a credible explanation, and suggested one that seemed to have most validity – namely, a contribution from Professor Michael Sharpe contained in a Report of the largest medical insurance company (UNUMProvident --- for Sharpe’s involvement with this company, see below) called Trends in Health and Disability 2002, in which Sharpe said about CFS: “There is strong evidence that symptoms and disability are shaped by psychological factors.  Especially important are patients’ beliefs and fears about their symptoms.  Causal factors are personality, disease attribution and avoidant coping style.  Obstacles to recovery (are) the current system of state benefits (and) insurance payments. It will be imperative that health and social policy address this problem.  Funding of rehabilitation by commercial bodies has begun in the UK (with organisations such as PRISMA) and is likely to continue”.

In our conclusion we said that bad science, bad  “policy” and vested commercial interests deserve to be exposed and criticised, but it seems likely from the MRC RAG document that a substantial number of very sick people with a complex neuro-endocrine-immuno-vascular disorder are not going to be allowed to stand in the way of those commercial interests.

(It is important to be aware that in 2000 [during the life of the CMO’s Working Group], the parent of an ME adolescent believed it vital that all members of the CMO’s Key Group and Children’s Group should each have a copy of Dr Byron Hyde’s 724 page seminal textbook on ME/CFS, so at her own expense she arranged for 128 copies to be shipped over from Canada direct to the Department of Health’s Headquarters Disability Section at Quarry House in Leeds.  It cost her £800.  She herself arranged that out of the 128 copies, twenty would be sent to the members of the CMO’s Key and Children’s Groups, which Helen Wiggins at the Department of Health in Leeds promised to do. On 27^th November 2003, Dr Charles Shepherd [Medical Adviser to the ME Association and member of the CMO’s Key Group] confirmed in writing that: “20 copies of Byron’s book may well have been intended to go to members of the CMO’s Key and Children’s group but I never received one. And I’m almost certain that nobody else on either of these two groups did either”.  The failure to provide the promised copies of this important textbook was but a fore-runner of what occurred during the life of the MRC Research Advisory Group: the person who had paid for the copies to be sent to the Department of Health had been informed that, of the original 128 copies, the remaining 108 would definitely be put to good and appropriate use, so when problems with the MRC RAG arose, she contacted Quarry Hill to arrange for copies to sent to each of the RAG members. Having managed to obtain the names and email addresses of every member of the RAG, she contacted each of them to advise them that they would be receiving a copy of the textbook.  What happened next is astonishing: the RAG members contacted Elizabeth Mitchell of the MRC about the book, who rang the parent of the sick youth and was very angry indeed, refusing outright to allow each member of the RAG to see a copy.  On 20^th October 2002, all Elizabeth Mitchell would agree to was that TWO copies could be sent from the Department of Health in Leeds to the MRC (which she insisted was to be at the parent’s own expense). When the parent contacted Quarry House in Leeds, she was told that the Department of Health had “lost track” of the remaining 108 textbooks.  The parent managed to establish that some had been dumped at the Cystic Fibrosis Service at Seacroft Hospital in Leeds, but that most of the 108 books were missing, believed trashed.  On 8^th January 2003 the parent was informed by Elizabeth Mitchell that she would allow the two copies to be available to RAG members before and after one meeting only, and that this was sufficient.  It seems unrealistic to expect each member of a group of busy people to be able to consider a 724 page textbook if it was available to them for only a few minutes before and after one meeting).

2003

Note on the apparent bias of MRC “CFS/ME” Research Advisory Group in their draft document for public consultation dated 17^th December 2002

M Hooper    EP Marshall     M Williams       2^nd January 2003

In this short document, entitled “Elementary Rules of Procedure”, we noted that there are in existence such rules, of which the MRC RAG seemed to be ignorant.  We noted that the MRC RAG consisted of experts of professorial status, so they would be expected to know that post-graduate students who undertake a higher degree by research are expected before proceeding to define the proposed topic and to produce a comprehensive review of the relevant literature.  Only by doing so can they place themselves in a position to ensure that their own prospective contribution represents a useful development of knowledge.  We posited that what seemed to be missing from the MRC RAG draft document was the prerequisite review of what has already been established about the disorder.

We noted that by neglecting this first step, the RAG members failed to ensure that their contribution would be situated squarely on the foundations of existing knowledge about the disorder, and we noted that as the pre-existing body of knowledge is extensive, it appeared to have been deliberately ignored by the MRC RAG, and that by proceeding as if this substantive body of mainstream knowledge did not exist, the authors of the RAG Report laid themselves open to suspicions of disingenuousness, or even frank intellectual dishonesty.  We commented that any conscientious academic supervisor would be obliged to reject the MRC proposal on the grounds that the proposed research strategy would not be expected to move understanding or knowledge along, but would only reinforce existing confusion.  We  noted that it was both disappointing and baffling that the MRC had allowed such a poorly-grounded, haphazard and potentially biased proposal to be entertained.

We received no acknowledgement from the MRC and our communication was ignored.

Some salient points arising from the AACFS 6^th International Conference which the MRC RAG might wish to consider

Margaret Williams        3^rd March 2003

The document summarised some of the findings at the AACFS International Conference that was held at Chantilly, Virginia, USA from 31^st January to 2^nd February 2003.  As with the preceding document, it was submitted to the MRC but was ignored.

The document noted that in their Introduction and Overview, Professor Charles Lapp (from North Carolina) and Professor Leonard Jason (from Chicago, Illinois) stated that in 50% of ME/CFS cases there was a family history of autoimmune disease and that people with ME/CFS were found to be more impaired than those with Type 2 diabetes, congestive heart failure, MS, or end-stage renal failure; there may be abnormal laboratory findings including immune complexes, atypical lymphocytes, lowered IgG, and anomalies in cholesterol, anti-nuclear antibodies and thyroid antibodies.  SPECT scans demonstrate decreases in cerebral blood flow with exercise; up to 50% of patients are unable to work.

The document noted that Professor Robert Suhadolnick (Temple University, Philadelphia) gave an over view of the biochemistry and genetics of ME/CFS and confirmed that immune activation and NK cell decrease are evident in most patients.  He confirmed that 2-5 RNaseL abnormalities have been shown in ME/CFS patients, particularly the severely ill, but not in healthy controls, and that elevated levels of RNaseL are associated with reduced maximum oxygen uptake and with exercise duration.  He also showed that there was an increase in markers of oxidative damage and that there is evidence of changes in brain function.

The document briefly summarised other presentations:  John Hay (from Buffalo, New York) presented evidence of infection and immunological changes, and noted the autoimmunity link in ME/CFS;  K Maher (from Miami, Florida) discussed the molecular defects seen in ME/CFS; P McGaffney (from Minneapolis, Minnesota) demonstrated a significant difference in gene expression, showing elevated expression of IL-1 (a very potent inflammatory cytokine) and noted that certain genes were dysregulated in almost all ME/CFS patients but in none of the controls; Dr Daniel Peterson (from Incline Village, Nevada)  showed abnormalities that included altered HPA axis, regional hypoperfusion in the brain, hypo brain metabolism, autonomic dysfunction and peturbation of brain hormones, as well as either primary or reactivated central nervous system infection.

Professor Ben Natelson (from New Jersey) showed that 44% of those with ME/CFS were found to have lumbar puncture results in the abnormal range for protein or white blood cells (thus supporting the view that some patients do have underlying pathologic brain processes that are responsible for their symptoms); Dr Christopher Snell (from Stockton, California) presented evidence of an abnormal response to exercise in ME/CFS patients; Dr Arnold Peckerman (from Newark, New Jersey) presented evidence of inefficient utilisation of respiratory muscles, and E Georgiades (from Glasgow, UK) had examined the cardiopulmonary and metabolic responses to exercise in ME/CFS patents compared with controls and reported that patients demonstrated impaired exercise tolerance.

As noted above, as with all our submissions to the MRC, our document was ignored.

Matters for the MRC RAG on “CFS/ME” to consider

Margaret Williams           6^th March 2003

Before the publication of the final MRC RAG Report, two further points were brought specifically to the attention of the MRC RAG:

1.     At the American Association of CFS (AACFS) 6^th International Conference in 2003, Professor Charles Lapp drew attention to the fact that Dr Daniel Clauw (Director of the Fatigue Research Centre at the University of Michigan) had studied the effects of CBT on over 1,000 patients and found that after three months, there were very modest improvements, but when followed up at six and twelve months, those modest gains were lost.

2.     On 2^nd March 2003, the Sunday Times reported that under the auspices of the Cochrane Collaboration, Simon Wessely had just led a review of the evidence for psychological counselling and that the Cochrane review concluded that such counselling was at best useless and at worst made people worse.

The question posed to the MRC was explicit: if counselling does not work, and if the aim of CBT is to counsel patients with ME/CFS about changing their beliefs and if, as shown by Clauw, CBT has no lasting benefit, on what ‘evidence-base’ will the MRC continue to grant £2.6 million to psychiatrists of the Wessely School to keep on looking at interventions that have already been shown not to work?

Short Review of New Publication by Professor Malcolm Hooper

Margaret Williams         4^th April 2003

This document noted that two new publications would be of paramount importance to both the Gulf War Veterans and the ME community: a news release by Robert Bradford, Senior Director of Communications at the Salk Institute, California, drew attention to published findings from the Salk Institute for Biological Studies at La Jolla, which was the first to demonstrate a clear genetic link between neurological disorders and exposure to organophosphate chemicals.

The second publication was a colour-illustrated fully referenced 85 page booklet by Professor Malcolm Hooper called “Engaging with Myalgic Encephalomyelitis”.  In his customary robust form, Hooper deals with facts, not beliefs or speculation, and those facts are soundly based on biochemistry, which those who promote a primary psychiatric pathoaetiology will find difficult to refute with any degree of credibility. Hooper is explicit: he writes that he has examined much of the ME literature and is “fully persuaded of the organic nature of this illness and the folly and cruelty of attempting to regard it otherwise”.

Hooper is unenthusiastic about the MRC RAG Report, stating that “much evidence was ignored” and he quotes the searing comments of world experts who pointed out that the Royal Australasian College of Physicians’ Guidelines upon which the MRC RAG relied were heavily flawed, biased, inaccurate and based on personal belief as opposed to evidence-based science.

He identifies various investigations, including more specialised tests than the basic screening advocated by the CMO’s Working Group Report, which are of major importance in diagnosis, together with treatment protocols that have a realistic prospect of success, including the removal from the diet of casomorphins (present in cows milk) and gliadomorphins (present in wheat).

The main thrust of the booklet is a detailed explanation of the neuroendocrine – immune paradigm and the interactive web of biochemical / physiological deficits found in ME patients, and it explained the mechanism by which chemicals cause changes that allow free transport of compounds into areas such as the brain and central nervous system from which they would normally be excluded and how they are then absorbed into the blood stream, giving rise to autoimmune diseases with very significant and chronic damage to health.

Ignoring the evidence?  A response to the final version of the MRC CFS/ME Research Advisory Group Strategy Report of 1^st May 2003

Malcolm Hooper    Eileen Marshall     Margaret Williams     5^th May 2003

Our concerns that without an adequate understanding of the underlying pathology of ME/CFS there could be no advance in the search for possible treatment were disregarded and all our documents were entirely ignored: the final RAG report that was released on 1^st May 2003 accepted Wessely School psychiatrists’ conjecture about the disorder in preference to a biomedical explanation, of which evidence there was a sustained rejection throughout the RAG Report. 

The RAG Report stated that it fully endorsed the conclusions of CMO’s Working Group Report; it asserted that studies of causal pathways of ME would do nothing to increase understanding of the disorder and it recommended CBT and graded exercise for those with “CFS/ME” and, specifically, that more studies of CBT and graded exercise should be undertaken, and that the direction of future management strategy should “concentrate on the effects of these interventions across the spectrum of the disorder”  (ie. on both the least severe and on the most severe cases).

Of particular note was the fact that the Report’s author was Dr Chris Watkins, whose title was “MRC Programme Manager for Research on Mental Illness”.

In our document, we recorded our specific concerns about the misinformation contained in the MRC RAG Report and drew attention to the apparently deliberate failure to confirm the WHO classification of ME as a neurological disorder (which exactly echoed the misinformation in the CMO’s Working Group Report of January 2002).

We noted that no-one denies the reality of psychiatric illness, nor the debility such psychiatric illness may cause, but what is at issue here is accuracy of case definition, which in our view has not been helped by the MRC RAG Report: whereas psychiatric illness is commonly amenable to psychotherapeutic interventions, complex neuro-immune disorders are not.

As was the case with the MRC’s initial Briefing about the need for “fresh” experts, the MRC once again seemed less than transparent about the Report itself, ensuring that the “take-home” message for the media about their RAG Report was that the MRC intended to make “CFS/ME” a priority area for grants. 

What it failed to disclose was that its preference was for grants to psychiatrists of the Wessely School: just two weeks after the release of the RAG Report, on 15^th May 2003 it became known that the MRC was to fund two trials of CBT for those with “CFS/ME” at a cost to the taxpayer of  £2.6 million (the PACE trials, an acronym for active Pacing, graded Activity, Cognitive behavioural therapy and Evaluation).

This was preceded by an announcement on 12^th May 2003 by the Health Minister (Jacqui Smith) that an additional £8.5 million was being made available by Government for services for those with “CFS/ME”. 

It quickly became obvious that these “services” are in fact clinics that will deliver CBT and graded exercise: job description advertisements for staff for these clinics stated that the aim is to “change perpetuating illness behaviour and modify predisposing personality style” for patients who “experience barriers to understanding” and stated  “there can be significant barriers to accepting the changes needed in behaviour, which have to be overcome in therapy”.  Significantly, the job descriptions also stated that for patients with CFS/ME, “medical intervention is no longer appropriate” and the service is extended to patients who have mental health problems; the post-holder is expected to “raise awareness of the approach adopted by the new centres to GPs and other local service providers”.

That would seem to be blatant proselytising for ME/CFS to be regarded as a mental disorder.

ME is suffering from inaccurate diagnosis

Janice Storey and Margaret Williams.

Biologist: June 2003:50: (3):104

This item in the “Letterbox” section of the Biologist stressed the need for accurate diagnosis and classification in ME; it drew attention to the published international evidence of a variety of biomarkers for the disorder and highlighted the fact that certain UK grant-awarding bodies are ignoring the large body of evidence of organic pathology in ME, preferring to allocate research funding to re-evaluate psychological management strategies that are more appropriate to aberrant illness belief.

Notes on the involvement of Wessely et al with the Insurance Industry and how they deal with ME/CFS claims

Margaret Williams     17^th June 2003

This referenced 21 page document considers the disastrous situation in relation to ME/CFS claims and the insurance industry: it provides evidence of the involvement of psychiatrists of the Wessely School as well as demonstrating the effects of this involvement on those with ME. 

In the document, we noted that when an MP requires information about ME/CFS, s/he usually turns to the House of Commons Library; however, it is known that an MP is often provided with information that is selected by House of Commons Library staff and a survey showed that MPs are provided only with information endorsing a psychiatric aetiology (even though books, journals and international conference reports etc that demonstrate the organic nature of the disorder are known to have been placed in the Library for the use of MPs, including Dr Byron Hyde’s 724 page textbook).  When the reason for this selectivity was legitimately queried, an MP’s constituent received an angry and intimidating letter from the Head of the House of Commons Library.  We noted that this seemed to indicate the immediate State / Government response when people dare to ask how an MP is provided with information about ME/CFS.  The same control of information seems to apply to the House of Lords, because a peer has ascertained that the information supporting an organic basis for ME/CFS has been removed to the Library archives, so is not available unless specifically requested.  Unless people know what is in the archives by name, it is difficult for them to request such information.

The document contains Appendices that set out actual case histories of individuals’ struggles with their insurers, including hard evidence of the coercion tactics used by insurers to force claimants to be seen by Wessely School psychiatrists, particularly Professor Michael Sharpe himself.

A further Appendix contains quotations from the published works and spoken views of Professor Michael Sharpe on the subject of ME/CFS (see below).

Spin Wins?

Margaret Williams    26^th July 2003

This short document noted that that MRC had openly declared its hand by categorically asserting (quote):  “CFS/ME does not refer to a specific diagnosis”.  It noted that the undifferentiated term “CFS” is an umbrella term that encompasses many disorders that are not ME (one such disorder being medically unexplained fatigue, which has no resemblance to ME), and it asked the MRC on what evidence it over-ruled the WHO classification of ME as a neurological disorder.  It noted that it is not sufficient for the spinners at the MRC to claim that ME is nothing more than collusion between  suggestible patients and naïve doctors who accept that such patients have a severe physical illness because the evidence is there for all to see, including the evidence that ME can be induced both by viruses (as in past epidemics) and by chemicals, and that its incidence is spiralling out of control.

The document noted that “spin” itself is now spinning out of control, because as far as ME is concerned, it is rampant throughout UK medicine, thanks to the unremitting efforts of certain psychiatrists who have indisputable links to the insurance and pharmaceutical industries, industries which stand to gain financially from the imposition of psychological regimes of CBT, graded exercise and antidepressants upon ME patients, many of whom are already at the limits of their endurance, but who are left in no doubt whatever that if they do not comply, their benefits will be stopped, either by the State or by their insurance company (and the financial gains of the psychiatrists themselves should not be forgotten either, for they are known to act as medical advisers to insurance companies that include UNUM, Swiss Life, Canada Life, Norwich Union, Allied Dunbar, Sun Alliance, Skandia, Zurich Life, Permanent Insurance, and the massive re-insurer Swiss Re).

The document noted that for the spinners who control Government policy on ME to continue to deliberately harm such people by denying the existing evidence of biomarkers of serious organic pathoaetiology shows that the spinners can have no morality, compassion, decency, integrity or humanity.

The views of the Medical Research Council on ME/CFS peer-reviewed publications

Margaret Williams             27^th September 2003

Following an article on 27^th September 2003 by Jerome Burne in the Times that questioned the MRC RAG Report’s recommendations, our document drew renewed attention to one of the more fallacious claims contained in the MRC RAG Report, which stated that findings in the biological area of CFS/ME are generally “not published in the peer-reviewed literature”, nor are such articles “well-described”.

In our response to the MRC RAG draft document for public consultation, we had listed 65 mainstream (mostly peer-reviewed) journals that had all published important biomedical evidence in relation to ME: those prestigious journals include some with a high impact factor, such as Nature, which has an impact factor of 29, and the New England Journal of Medicine, which also has an impact factor of 29. (In science and medicine, journals are allocated an “impact factor”; as a general rule, journals with a high impact factor are amongst the most prestigious and are relied upon by funding bodies and policy-makers).  Other journals we listed included JAMA, Annals of Internal Medicine, Reviews of Infectious Diseases, CRC Critical Reviews in Neurobiology, Archives of Internal Medicine, Quarterly Journal of Medicine and many more, thus exposing the erroneous and infantile assertions of the MRC RAG Report .

The document was ignored, just as our original submission as part of the MRC “consultation process” had been ignored.

The Mental Health Movement: Persecution of Patients?  Briefing Paper for the House of Commons Select Health Committee

Document prepared for the Countess of Mar by Professor Malcolm Hooper, in collaboration with members of the ME community.         December 2003

This comprehensively referenced 75 page spiral bound volume was prepared for the House of Commons Health Select Committee which, following a meeting on 24^th March 2004 of its then Chairman (David Hinchliffe MP) with the Countess of Mar, was to have considered the whole issue of ME/CFS: at that meeting, Hinchliffe had shown himself to be appalled at the situation and seemed very keen to take the matter forward via his Committee, promising in person that this would happen and that he would take advice, but just a few days later, someone (not Hinchliffe himself) contacted Lady Mar to say that it would not be possible for the Select Health Committee to consider the issue of ME/CFS.

The prepared document asked if it is the case, as demonstrated in a recent TV documentary, that multi-national corporations and not governments now rule the world, and if powerful and influential psychiatrists who work within the Mental Health Movement are linked to these corporations that now dominate and control medical and research institutions and whose life-blood is profit?

The document presented evidence to show that:

·        In the UK, patients with ME/CFS, particularly children, have suffered gross and barbaric abuse and persistent denigration as a consequence of the beliefs of certain psychiatrists who are attempting to control the national agenda for this complex and severe neuro-immunological disorder, who by their words and deeds have wreaked havoc in the lives of ME/CFS patients by their arrogant pursuit of a psychiatric construct that ignores the abundant scientific and medical evidence of organic pathology

·        There have been persistent and frequently covert attempts by these psychiatrists to subvert the international classification of ME/CFS from neurological to psychiatric, with destructive consequences for those affected

·        These psychiatrists have propagated untruths and falsehoods about the disorder to the medical, legal, insurance and media communities, as well as to Government Ministers and to Members of Parliament, resulting in the withdrawal and erosion of both social and financial support for those with ME/CFS

·        Influenced by these psychiatrists, Government bodies such as the MRC have continued to propagate the same falsehoods, with the result that patients are left without any hope of appropriate health service provision or delivery.

The document asked the Select Health Committee to address two specific questions:  (i) is the Department of Health’s current and proposed policy on the management of ME/CFS as provided and promoted by psychiatrists of the Wessely School harmful to patients and   (ii) are such patients being abused as a consequence of scientific misconduct?

It pointed out that merely to state that there is “medical disagreement” over ME/CFS is not enough, as people with power are misusing that power against sick and vulnerable people and are using it to further their own vested interests, and that no-one in authority is listening.

The document spelled out the tactics of denial used by Wessely School psychiatrists, demonstrating especially how the denial is directed at undermining the expertise of doctors who hold different views about ME/CFS from themselves, and how the deniers apply a double standard to the evidence – they support their own claims with a select choice of studies that have been shown in the medical literature to be flawed, whilst insisting that those who oppose them provide irrefutable proof of an organic pathology (which when provided, they simply ignore).

The document provided two Appendices containing quotations from the published works of Professor Simon Wessely and Professor Michael Sharpe on ME/CFS, those from Wessely’s works covering the period from 1988 to 2003 and those from Sharpe covering the period from 1991 to 2000, the latter including Sharpe’s better-known quotations, for example:  “psychiatric management may be defined as treatment of the mentally ill”; “viral infection is of theoretical interest but of minor importance”;  “personality factors (attitudes, beliefs, thoughts) and behaviour have been shown to perpetuate disability.  These dysfunctional cognitions include the beliefs that recovery is not under personal control”;  “the exclusion of persons (with psychiatric disorders) would substantially hinder efforts to clarify the role that psychiatric disorders have in fatiguing illness”; “evidence for the superiority of CBT is in keeping with the evidence that the perpetuation of unexplained somatic symptoms is best understood in terms of psychological factors (such as) misinterpetation of bodily sensations and unhelpful coping behaviour”;  “(patients’) beliefs are targets for therapeutic interventions”;  “many physicians are reluctant to make the diagnosis of CFS (because of) reinforcing unhelpful illness beliefs”;  “patients need a diagnosis in order to organise their dealings with the world of benefits”;  “CFS may serve as a culturally defined function which allows a socially acceptable expression of distress”; “referral to ‘specialists’ should be avoided as they can entrench illness behaviour” (presumably Sharpe here excludes referrals to psychiatrists).

Sharpe is known to have recommended to medical insurance companies that claimants with ME/CFS should be subjects of covert video surveillance, whilst in its “Chronic Fatigue Syndrome Management Plan”, the insurance company UNUM (with which Sharpe is closely involved) proclaims about “CFS”: “DIAGNOSIS: neurosis with a new banner”.

Sharpe is also known to have received many letters from ME/CFS patients themselves, as well as from their despairing carers, to one of whom he replied on 25^th April 2000:  “Whilst I understand your desire to have the condition classified as a Neurological Disorder, as I said previously I am not convinced this is in fact the best strategy.  This is because trying to change doctor’s behaviour (sic) by altering classifications probably will not work and might even provoke a paradoxical response.  I suspect that (your tactics) are as likely to backfire as to further the cause of obtaining better treatment for patients”.

This response from Sharpe is curious, given that ME has been formally classified as a neurological disorder since 1969, a fact of which this influential “expert” seemed to be unaware.

The document pointed out that as with Wessely, it is not just a matter of noting the more offensive statements but rather it is the relentlessness of the same message over and over again, and the fact that the message does not adapt to – but actively dismisses – the strength of emerging biological evidence which shows these psychiatrists to be out of touch with international scientific knowledge about the disorder.

2004

Comparison of MRC-funded research and MERGE-funded research into ME/CFS

Margaret Williams          20^th March 2004

This document briefly compared the usefulness of the psychosocial studies of CBT that are to be funded by £2.6 million with the outstanding work that the small charity MERGE (ME Research Group) has successfully funded from donations, noting about the former that the 25% ME Group for the Severely Affected stated “there is little or no evidence to support the claim that ME patients will benefit from the highly controversial and hotly contested psychological treatment strategies”.

By comparison, MERGE is dedicated to biomedical research into the causes, consequences and treatment of ME, and despite being desperately short of funding has already achieved far more in furthering the understanding of ME/CFS since its inception in 2000 than the MRC has achieved in the last 20 years.

Our document summarised MERGE’s presentations at a Royal Society of Edinburgh Workshop held on 3^rd October 2003: 

Everyday in the UK, between 120,000 and 240,000 people waken with debilitating malaise and pain; they remain ill and largely ignored by mainstream medicine. Graded exercise therapy is not universally successful in ME/CFS.  The human cost of ME is substantial and has not been well reported.  A range of abnormalities has been found in ME by a number of different research groups (biochemical, vascular, brain and muscle). The microvascular research laboratory at Dundee has demonstrated that the vascular response in ME is very unusual and is unlike any other diseases encountered.  There may be re-perfusion injury in ME patients  (a state where the vasodilatation that is necessary for the delivery of nutrients is compromised). Vascular symptoms characterise ME and data show that arterial stiffening is increased in some patients with ME.  Blood vessels of patients with ME have been shown to be abnormally sensitive to acetlycholine, a most unusual if not unique situation.  The central hypothesis is that there is endothelial dysfunction in ME: circulating levels of endothelin-1 (one of the most powerful vasoconstrictors) have been shown to be raised in people with ME (high levels have been reported in myocardial infarction, in diabetes and in HIV infection).  The symptoms of post-exertional myalgia in ME may be akin to those experienced by the vascular patients with intermittent claudication.  These findings are suggestive of an underlying viral or toxic illness associated with persistent infection and immune activation.

The document asked what possible justification can the MRC and Government have for continuing to ignore the pleas for funding research into the biomedical aspects of ME/CFS, whilst continuing to fund yet more psychiatric “research”, the aim of which seems to be to deny the organic nature of such a uniquely complex organic disorder.

Some questions about ME/CFS to which credible answers are urgently required

Malcolm Hooper   Margaret Williams   22^nd March 2004

This document was prepared for the Countess of Mar’s various meetings with the Chief Executive of the MRC (Professor Colin Blakemore), MPs and Ministers; it set out the many problems with the CMO’s Working Group on “CFS/ME”, as well as problems with the MRC and with NICE (National Institute for Clinical Excellence, whom both the CMO and the MRC have asked to develop clinical guidelines for the diagnosis and management of “CFS/ME”).

In relation to the MRC, the document asked how the MRC can possibly justify the granting of millions of pounds sterling to Wessely School psychiatrists, given that their work has been universally shown to be flawed, and given also that they themselves concede that for those with ME/CFS who have taken part in their trials of CBT and graded exercise, there is no lasting benefit at follow-up.

It asked how the MRC could be unconcerned that the PACE trials run by Professors Peter White, Michael Sharpe and Simon Wessely are to use the Oxford 1991 (psychiatric) criteria for “CFS”, given that those criteria have been shown to have no predictive validity and have never been adopted internationally and, most importantly, when they specifically include those with chronic fatigue due to psychiatric disorders and specifically exclude those with any neurological signs (such as occur in authentic ME); we drew attention to the reason given in the Trial Identifier itself: “We chose those broad criteria in order to enhance recruitment” and we asked how this can be “evidence-based medicine”?

We expressed concern that these Trials are to include those with fibromyalgia (FM), given that FM is classified by the WHO as a distinct entity (ICD-10:M79), whereas ME is classified at G93.3, and given that FM has a discrete biomedical profile that is entirely distinct from that found in ME/CFS.  We provided evidence that the Government already recognises FM to be a quite separate disorder, and we asked how can the deliberate inclusion of patients with FM not result in skewed and meaningless conclusions when the patients being entered into the MRC trials are, from the outset, not clearly defined?

(It is the case that at a meeting of the All Party Parliamentary Group on Fibromyalgia held on 12^th May 2004 at the House of Commons, the Parliamentary Under Secretary of State at the Department of Health [Dr Stephen Ladyman MP] announced that GPs would be offered financial incentives and encouraged to identify patients with fibromyalgia and to refer them to the new “CFS/ME” centres, where these fibromyalgia patients would be included in the MRC “CFS” study. It remains to be explained how the lumping together of such a deliberately heterogeneous study population in the MRC trials can yield accurate and meaningful scientific results, when by virtue of the chosen entry criteria, [Oxford 1991] those with authentic ME will have been excluded from the outset [see below], yet despite this, it seems that the results of the MRC PACE trials on “CFS/ME” are likely to be claimed to relate to those with ME).

In relation to NICE, we pointed out that NICE funds the “Effective Healthcare” bulletins which are disseminated throughout the NHS, drawing attention to the issue on CBT and graded exercise as the management of choice for “CFS/ME” (see Effective Healthcare 2002: No.7: Vol 4; 23^rd May) and asked how, when the views of NICE have already been established and have been shown to publicly promote the psychiatric model of “CFS/ME”, NICE can be expected to produce unbiased advice in the future without losing face?

2005

Problems and Solution?

Eileen Marshal    Margaret Williams    23^rd February 2005

This document noted that a Radio interview on 22^nd February 2005 with Professor Colin Blakemore (Chief Executive of the MRC) encapsulated the essence of an iatrogenic problem that since 1987 has compounded the suffering of those with ME, and noted that if his pronouncements had been on any other disorder but ME, Blakemore would surely have been pilloried by the media.

Blakemore was asked why the MRC had failed to fund any biomedical research into ME but instead had funded only psychiatric studies that failed to address the neurological, cardiological, immunological and other abnormalities highlighted in international research but ignored in the UK.

His verbatim response was: “I know that this is a very current issue of very great concern to ME sufferers. I think to concentrate on this question of whether ME is thought to be a neurological or a psychological condition actually isn’t going to get us far…I don’t think we should look down our noses at psychological treatments”.

Our paper commented that his declaration that there is no need to worry about whether or not the disorder is either psychological or neurological in causation would seem not to be in accordance with the rigorous approach that is necessary for progress to be made in medical science, and asked if Blakemore really saw no need to search vigorously for the cause of ME: if so, why does such an approach relate only to ME and not to all illnesses whose cause is not yet known, including cancer, multiple sclerosis and lupus?  We asked what is the purpose of the MRC if not to conduct research into illness that will provide understanding of (and result in treatment for) that illness?

We noted that Blakemore’s support for the current MRC trials on “CFS/ME” (that have been widely shown to be flawed from the outset by virtue of the entry criteria chosen by the psychiatrists who are running the trials, which by definition exclude those with ME) was disturbing, and that Blakemore was wrong to state unequivocally that the current MRC trials include those with ME, as there can be no credible doubt that the Oxford case definition excludes those with neurological disorders: this was confirmed by psychiatrist Anthony David (colleague and co-author with Wessely) who referred to the Oxford criteria shortly after they were published:  “British investigators have put forward an alternative, less strict, operational definition which is essentially chronic fatigue in the absence of neurological signs (but) with psychiatric symptoms as common associated features”  (AS David. Postviral syndrome and psychiatry.  British Medical Bulletin: 1991:47:4:966-988).

Given that ME has been classified by the WHO as a neurological disorder since 1969, and given also that the UK Minister of Health (Lord Warner) confirmed on 11^th February 2004 in writing that the Department of Health accepts the correct classification for ME is neurological, we asked how it can be acceptable for Blakemore to claim that the MRC is funding trials on ME when evidence abounds that this is untrue, and how he can assert that the MRC needs “high quality proposals” but then openly support those trials when the inherent design flaws have (to no avail) been repeatedly brought to the attention of the MRC?

(This important issue cannot to be ignored:  on 15^th May 2004 the MRC trial Principal Investigators, Professors Peter White and Michael Sharpe, posted a notice “Correcting some misunderstandings” on the Co-Cure internet site in which they asserted: “The criteria that we will use to include patients with CFS/ME do not exclude ME”:  if the Department of Health accepts that the WHO classification for ME is neurological [and the same Department of Health is on record as accepting ME as an organic disorder in November 1987 and as reiterating this acceptance on 15^th March 1992 when the Under Secretary of State for Health confirmed in writing that “a physical cause for ME is recognised”, as well as on 16^th August 1992, when the Under Secretary of State for Health stated “ME is established as a medical condition”], and if people with ME exhibit neurological signs, and if the Oxford MRC trials entry criteria expressly exclude those with neurological disorder and exclude those with any physical signs, by what reasoning can those with authentic ME be included in the MRC trials?  The ME Association has called for the MRC trials to be abandoned and the MRC has been deluged with letters of concern about these trials, all to no avail.  One such letter was from Dr David S, a psychopharmacologist, who wrote to the MRC saying:  “I am appalled to have to bring to the attention of the MRC that both massage of the diagnostic criteria and experimental protocol [including the “loss of data” from non-compliers] appears to be taking place in two areas of research into CFS/ME.  These are not allegations to be taken lightly and I expect the MRC to launch an immediate investigation”.  The question remains: if by definition the MRC trials exclude those with authentic ME, what is to be provided for the 240,000 people that the Government says suffers from CFS/ME, about whom Lord Warner has made the Government’s position quite clear, and who will benefit from the £11.1 million granted to Wessely School psychiatrists?).

Science or Psychology?

Margaret Williams     29^th March 2005

While the furore over the MRC trials entry criteria raged on, an equally if not more disturbing concern about these trials was raised again, namely that they might be detrimental and even dangerous for those with authentic ME: whilst Simon Wessely was busy promoting his meta-analysis of the placebo response in CFS as reported on 22^nd March 2005 in the Washington Post (“Researchers say people need to be convinced that behavioural therapy and regular exercise can help them overcome symptoms of chronic fatigue syndrome”), scientists were publishing results that showed such regimes exacerbate the symptoms in ME/CFS.

This document noted the impressive and significant study by US researchers from the Centres for Disease Control in Atlanta, including world experts such as James F Jones and Suzanne D Vernon (BMC Physiology: 2005:5:5), which was unequivocal:  using gene profiling, they found that “Activities that are physiologic stressors, such as physical exercise, exacerbate the symptoms that define ME/CFS.  It is evident that ion transport and ion channel activity segregate cases from controls and that exercise seems to intensify these differences. Several other conditions have been reported that are known to be caused by abnormal ion channels.  These conditions include multiple sclerosis and polyneuropathies”.

As ever, the MRC did not acknowledge this document.

Profits before