Mind Games: ME-dical malPRACTICEs ?

28th May 2010 Bispebjerg Hospital, Copenhagen

1st Danish ME/CFS Association Conference with The European Society for ME (ESME)

Malcolm Hooper PhD, B Pharm, ARIC, C Chem

Emeritus Professor of Medicinal Chemistry, University of Sunderland, UK

ME (female) 4 vs

CFS (male) 1

With thanks to Michael Maes for the title

THE BIG DIVIDE

SOMATISATION ALL IN THE MIND

PSYCHOSOCIAL

COMPLEX CHRONIC MULTI-SYSTEM CONDITION

BIOMEDICAL BASIS

1. CLAIMS

2. EVIDENCE

3. POLICY

MYALGIC ENCEPHALOMYELITIS IS A

–COMPLEX

- CHRONIC

- MULTI-SYSTEM ILLNESS

“I might be criticised for presenting alarming material [about ME] but I have tried to present the truth and this in perspective” Dr John Richardson (1915-2002 50 years study)

“Everything that cannot be understood does nevertheless not cease to exist.” Blaise Pascal (1623-1682)

[MUS, PUPS, MUPS – ‘UNEXPLAINED’ ILLNESSES- VANISH]

Compiled by Natalie Boulton

www.jivalobo.com/invisibleME

Making the invisible – visible

LISTEN TO PATIENT VOICES

History- History- History Listen to Patient and to Patient’s Parents – especially the Mother.

John Richardson -1999

John Chia 2010

LINDA – VERY SEVERE ME - >20

YEARS.

TOUCH, LIGHT, SOUND - ARE AGONY

PHOTO/ PAINTING BY HUSBAND GREG

PAIN PARALYSIS

SYNDROMES OF UNCERTAIN ORIGINSMerck Manual 1999, 17th Edition

GULF WAR SYNDROMEGWS/I

MILITARY ME

MULTIPLE CHEMICAL

SENSITIVITY

ME-CFSFMS

SOMATISATION- PSYCHIATRIC- THEY ARE ALL IN THE MIND

OPs

MULTI-SYSTEM & ORGAN NEUROLOGICAL- ANS, PNS, CNSCARDIOVASCULARIMMUNE SYSTEMGASTROINTESTINALRESPIRATORYENDOCRINE SYSTEM

“Considering the extent of the patients’ complaints and disability, the results of ROUTINE laboratory tests were strikingly NORMAL” S Straus

SYMPTOMS OPs GWS MCS FMS CFIDS MS AIDS

JOINT PAIN + + + aroundjoint area

+ + +

FATIGUE + + + + + + +HEADACHE + + + + + + +MEMORYPROBLEMS

+ + + + + + +

SLEEPDISTURBED

+ + + + + ?? due tomedicines

+

SKINPROBLEMS

+ + + + + burningskin

+

PROBLEMSCONCENTRN

+ + + + + + +

DEPRESSION + + + + + + +

MUSCLE PAIN + + + + + + +DIZZINESS + + + + + + +G.I. - Irr. Bow. + + + + + + +PERIPHPARESTHES/TINGLING

+ + + + + + +

CHEM/ENVIR SENSITIVITY

+ + + + + Reported _

EYEPROBLEMS

+ + + + + + +

ANXIETY + + + + + + +TACHY&/OR CHEST PAIN

+ + + + + + +

BREATHINGPROBLEMS

+ + + Reported + + +

LIGHTSENSITIVITY

+/- + + Reported + + _

+ Literature. Reported = Anecdotal Adapted from Jackie Burkhead

ME/CFS AND OTHER OVERLAPPING SYNDROMES.

WHAT’S IN A NAME? ME vs CFS

WHO - ICD 10 - G93.3 (FROM 1969) IS CLEAR MYALGIC ENCEPHALOMYELITIS IS A NEUROLOGICAL DISORDERMUSCLE PAIN WITH INFLAMMATION OF THE BRAIN AND SPINAL

CORD

[THE ONLY ALLOWED ALTERNATIVE NAMES AREPOST-VIRAL FATIGUE SYNDROME, PVFS, CHRONIC FATIGUE SYNDROME, CFS]

ME DESCRIBES A PATHOPHYSIOLOGICAL CONDITION WITH CLEAR MEANING FOR CLINICIANS AND ALLIED SCIENTISTS

CHRONIC FATIGUE DESCRIBES A SYMPTOM – SUBJECTIVE – PROVIDES NO OBJECTIVE CLINICAL SIGNS FOR DIAGNOSIS- MAKES MISCHIEF POSSIBLE

PVFS DESCRIBES AETIOLOGY (VIRUS INDUCED) + A SYMPTOM - FATIGUE

NOT ENCEPHALOPATHY (NOT CLASSIFIED) –MYALGIC ENCEPHALOMYELITIS

Decreasing objective information clinical, diagnostic, scientific, aetiological.

FUNCTIONAL SOMATIC SYNDROMES: ONE OR MANY? Wessely et al Lancet 1999;354:936-9 PSYCHOSOCIAL SCHOOL PARADIGM

Gastroenterology – IBS, Non-ulcer dyspepsia

Gynaecology – PMS, chronic pelvic pain

Rheumatology – Fibromyalgia

Cardiology – Atypical or non-cardiac pain

Respiratory medicine – hyperventilation

Infectious Disease – PVFS- ME-CFS

Neurology – Tension headache

Dentistry – TMJ dysfunction, Atypical facial pain

ENT – Globus syndrome

ALLERGY - MCS

CANNOT EXPLAIN BYCONVENTIONAL PARADIGMS

CONVENTIONAL THERAPY INEFFECTIVE

MORE COMON IN WOMEN THAN MEN

SHARE NON-SPECIFIC SYMPTOMS

SYNDROMES RESPOND TO SAME THERAPIES, CBT/GET, PACING, PARTLY SUPPORTED– PATIENT SELECTION/DEFINITION CRUCIAL.

MISREPRESENTATION AND WORSE

FITNESS FOR WORK - OUP-2004 REPRINT £50-00 IN ASSOCIATION WITH RCP FACULTY OF OCCUPATIONAL MEDICINE

WESSELY et al p.132 - incl, Maurice LIPSEDGE Consultant Psychiatrist KCL.

BRIEF INFECTION (USUALLY VIRAL) >>>

VULNERABLE PERFECTIONIST PERSONALITY + PRESSURE AT WORK

EMPLOYEE SICKNESS ABSENCES>>>

FATIGUE >>>>

PROLONGED BED REST >>>>

MALADAPTIVE BELIEFS >>>

CHRONIC INVALIDISM>>>

TERMINATION OF SERVICE ON MEDICAL GROUNDS. ALL LAZY CHILDREN - INACTIVE >>>>

+/- PENSION !

STEPHEN RALPH -12/6/04 - www.meactionuk.org.uk

Twisk & Maes 2009; Wessely & Wood , 1999! supply EVIDENCE SHOWING SOME OF THESE CLAIMS TO BE IN ERROR.

“They reduce disability, & enhance control over symptoms”.

“Modestly effective”.

“Not remotely curative”.

“These interventions are not the answer to CFS”.

Professor Simon Wessely, Journal American Medical Association Vol. 286, #11 Sept. 19, 2001. Read your own papers please! Twisk & Maes 2009 make same point

Efficacy of CBT & GET - FROM THE “HORSES

MOUTH”.

Efficacy of CBT & GET - FROM THE “HORSES

MOUTH”.Why then spend £8.2 million on clinics etc ?

CHAPTER 7

Psychiatry and neuropsychiatry

7.6 “Nearly all studies find that between one-quarter to one-third of those who fulfil criteria for CFS do not fulfil ANY criteria for psychiatric disorder. Any simple equation of CFS with psychiatric disorder is thus erroneous”.

A Psychiatric Condition?

SOMATIC MEDICINE ABUSES PSYCHIATRY – AND NEGLECTS CAUSES

An almost TOTAL lack of SCIENTIFIC support

Reclassifying BODILY symptoms as MENTAL problems…where CONVENTIONAL medicine is at a loss for an explanation.

LACK OF firm KNOWLEDGE is converted into SPECULATIVE ASSERTIONS without any CRITICAL voices being heard. PD, MS, Diabetes

Causal explanation for illnesses .. go with predominantly somatic symptoms [that] lack any basic similarity to known mental disorders.

An evasive argument…with its lamentably poor record of research into causes, particularly where environmental factors are concerned.

Industrial interests are actively influencing the course of what is ostensibly a scientific discussion.

What makes an individual human being ill cannot be determined by statistics

Lack of knowledge is a considerable handicap in the treatment of chronic diseases

Per Dalen (Psychiatrist) http:art-bin.com/art/dalen_en.html

Mercury, Lyme’s disease, placebo effect, toxicology, epidemiology

N McLaren THE (BIO)PSYCHOSOCIAL MODEL and FRAUD

“I see psychiatry under attack from all quarters. Some people see a great future for us. I don’t share that view. I believe there is a serious risk that psychiatry as we know it will no longer exist in as little as fifteen years. The reason is simply a lack of anything approximating an adequate intellectual framework for our efforts.”

This model was the basis for the rejection of the Class Action brought by GWVs and persists still- see Phil Trans Royal Soc 2006;631:689-695.

The myth of the biopsychosocial model.Australian and New Zealand Journal of Psychiatry 2006; 40 (3), 277-278

http://www.futurepsychiatry.com/ Chapters 7 and 9

This model is based on fraud and ignorance and a complete misunderstanding of the origins of the idea. It is a myth.

THE DECEPTION !

MYALGIC ENCEPHALOMYELITIS – CHRONIC FATIGUE SYNDROME AT G93.3 [NEUROLOGICAL DISORDERS]

[MENTAL & BEHAVIOURAL DISORDERS – F48.0]

NEUROLOGY G93.3

PSYCHIATRY/PSYCHOLOGY F48.0

CHRONIC SYNDROME

DUAL CLASSIFICATION IS NOT ALLOWED UNDER RUBRICS OF WHO

FATIGUE SYNDROMES CHRONIC FATIGUE

NIH-CFS DEBATE, 2007 -19 YEARS AFTER DECISION

Dr Donna Dean

1. ME/CFS carries significant STIGMA for PATIENTS

2. MEDICAL COMMUNITY bears some responsibility for invalidating ME/CFS as a REAL condition.

3. PATIENT ADVOCACY bears come some responsibility – working at cross-purposes even among themselves.

4. NIH Panel MEMBERSHIP is SIGNIFICANTLY BIASED towards the BEHAVOURAL side of research.

Prof Anton Komaroff

“None of the participants in creating the 1988 CFS case definition and name ever expressed any concern that it might TRIVIALISE the illness. We were insensitive to that possibility and WE WERE WRONG.

THE NAME DIVIDES – The medical community that has tried to abandon the use of ME, replacing it by CFS. Patients INSIST on using ME.

BIGGEST DIVIDE: PSYCHIATRY, ALL IN THE MIND. SOMATISATION/SOMATOFORM DISORDER vs BIOLOGICAL- ORGANIC ILLNESS.

25% ME GROUP [THE SEVERELY AFFECTED-1/3/O4

RANDOM SAMPLE -437 = 66% OF MEMBERSHIP

COMMENTS ON TREATMENTS GIVEN

H% UNH%

PERSON-CENTRED COUNSELLING 54 46

PSYCHOTHERAPY 10 90

CBT* 7 93

GET* 5 95

PACING* 70 30

ALTERNATIVE THERAPIES 60 40

SYMPTOMATIC CARE MANAG 73 30

PAIN MANAGEMENT 75 25

* £8.2 MILLION GOVERNMENT FUNDING HAS BEEN COMMITTED TO CLINICS OFFERING ONLY THESE TREATMENTS. WHY?

1. Interventions – CBT, GET, Pacing, Stand Med Care

2. NO OBJECTIVE CRITERIA WERE USED- Exercise or Biological (White- Chief Investigator of the Trial, lead among Principal Investigators White, Sharpe, Chalder. In 2004, White showed raised levels of TNF- sustained at least 3 days after exercise. He needs to read his own papers! )

Hooper, Williams with Members of the ME Community – 2010. Download www. meactionuk.org

CBT IS NOT HARMLESS – TO IGNORE SYMPTOMS IS TO INVITE SERIOUS CLINICAL PROBLEMS- MISSED DIAGNOSES- MISDIAGNOSES see BYRON HYDE’S LATEST BOOK.

GET IS POSITIVELY DANGEROUS LEADING TO EXTENSIVE RELAPES AND EVEN DEATH!

BRYNMOOR JOHN MP ME + EXERCISE DIED ON WESTMINSTER BRIDGE IMMEDIATELY AFTERWARDS.

CFS – CBT - GET

SHORTENED LIFE EXPECTANCY/DEATH – HEART FAILURE 20.1% (58.7)[83.1]; CANCER 19.4% (47.8)[72.0]; SUICIDE 20.1% (39.3)[48.0]

CHRONIC FATIGUE SYNDROME – DEFINITIONS DETAILS

1994 Case Definition: Fukuda et al Ann Int Med Dec 1994 – this the most widely used clinically/Research. Oxford also still employed by some.

Characterised by: Medically unexplained Of new onset At least 6 months duration Not the result of ongoing exertion Not substantially relieved by rest Substantial reduction in previous activities

With 4 of the following: impaired memory/concentration Sore throat Tender cervical lymph nodes Myalgia Headaches of new type Unrefreshing sleep Post-exertional malaise (Some with ME-CFS) Multi joint pain without swelling or redness

OXFORD1. Disabling fatigue of uncertain cause.2. Psychiatric disorders not necessarily excluded.3. Any identifiable biomedical illness excludes.

SELECTS ONLY PSYCHIATRIC PATIENTS NOT ME-CFS.

CFS/MEn=48

OPn=25

GWn=24

Sore Throat 25(52%)

12(48%)

11(46%)

Concentration/Memory Problems 48(100%)

24(96%)

24(100%)

Glands 27(56%)

6(24%)

9(38%)

Muscle Pain 45(94%)

6(24%)

9(38%)

Joint Pain 37(77%)

19(76%)

23(96%)

Headaches 28(58%)

17(68%)

21(88%)

Sleep 43(90%)

18(72%)

23(96%)

Post Exercise Fatigue 48(100%)

24(96%)

23(96%)

1994 FUKUDA CDC classification found wanting symptoms [number (%)]

Kennedy, Spence et al Ann Epidemiol. 2004;14:95-100

MAJOR COMMON FEATURES

CANADIAN CONSENSUS PANEL CRITERIA FOR M.E. - 2003

FATIGUEPOST-EXERTIONAL MALAISE & FATIGUESLEEP DISORDERSPAINNEUROLOGICAL /COGNITIVE MANIFESTATIONS (2 or more)

AT LEAST ONE SYMPTOM FROM 2 OF FOLLOWING CATEGORIES

AUTONOMIC - NMH, POTS, Delayed Postural Hypotension, Low plasma and/or RBC volume, Vertigo, Light Headedness, Extreme pallor, Intestinal or Bladder, disturbances with IBS or Bladder dysfunction, Cardiac Arrhythmias, Vasomotor Instability, Respiratory Irregularities

NEUROENDOCRINE - Thermostatic instability- heat/cold intolerance, Anorexia or Abnormal Appetite, Marked weight change, hypoglycaemia, loss of adaptability /tolerance to stress and slow recovery from stress, emotional lability

IMMUNE - tender lymph nodes, sore throat, flu-like symptoms, general, general malaise, development of new allergies or change in status of old ones, hypersensitivity to medications and/or chemicals.

De MEIRLEIR –FROM RNase L etc IDENTIFIES 3 MAJOR SUB-GROUPS 1999- 2005.

KERR et al 2005, 2007, 2010 - GENETICS - 8 CLINICAL PHENOTYPES, SNPs

NEWTON et al. 2007 2 SUB-GROUPS - 75% ME-CFS patients have DYSAUTONOMIA WITH THEIR FATIGUE

Roberto Patarca-Montero. JCFS 2000:7(4):1 “the sorting of patients into subpopulations….is helping in the design and interpretation of clinical trials for therapeutic interventions aimed at particular disease manifestations”.

ALL HAVE DIFFERENT TESTING & TREATMENT IMPLICATIONS

CANADIAN CRITERIA, 2003, SUB-GROUPS ESSENTIAL AND CHARACTERISED.

Jason et al, 2005 showed need for sub-groups

NOT a Fatigue Syndrome/Neurasthenia. ICD-10 G.93.3 NOT F.48.0

NOT Chronic Fatigue - many causes, Amer Med Assoc 1990

NOT Clinical Depression fails clinical tests –Richardson et al and many others

NOT Burnout – cortisol responses differ Mommersteeg et al

ME CLASSIFICATION AND NOMENCLATURE

NOT DECONDITIONING - Burnett, Newton.

NOT CFS - Spence et al, Olano et al

WHAT ME IS NOT!

SUMMARY OF BIOMEDICAL EVIDENCE

Twisk & Maes, 2009

SF-36 SCORES MEAN OF GENERAL POPULATIONS

PF= Physical Functioning (10); SF = Social Functioning (2); RP= Role Limitations Physical Problems (4); RE= Role Limitations Emotional Problems (3); MH=Mental Health (5); VT= Vitality/Energy (4); BP = Pain (2); GH = General Health (5)

ME/CFS, OP & GULF WAR

PF SF RP RE MH VT BP GH

WESSELY et al UNABLE TO DISTINGUISH BETWEEN SICK AND ‘WELL’ GWVs - JOEM 2003;45:668-675.

OTHER CHRONIC ILLNESSES - SCORE < 72 HEART FAILURE, DIABETES, RECENT MI, COPD, DEPRESSION. Haley 2004 Lloyd Inquiry

MAJOR CHAPTERS ON VIRUSES

Cardiovascular Consequences

Central Nervous System

Glandular Effects

Pregnancy

Neoplasms

Toxins OCs mimic ME

Treatment Considerations

THIS IS A MAJOR CLINICAL WORK THAT REPRESENTS A LIFE TIME OF DEDICATED STUDY AND PATIENT CARE.

Brain blood flow by PET Scans differentiates ME/CFS from depression

ISBN 0-7890-1127 Haworth Medical Press, 2001

1992- Byron Hyde, Jay Goldstein, Paul Levine (Eds)

74 Chapters covering all aspects of ME-CFS

Modern Techniques- SPECT , PET, MRI (MRS)

Numerous Clinical Studies

Multi system effects

Effective Treatments

Chia JKS. The Role of Enteroviruses in Chronic Fatigue Syndrome- A Review J Clin Pathol 2005;58:1126-32

Enteroviruses are well known causes of acute respiratory and gastrointestinal infections, with tropism for the central nervous system, muscle, and heart. Initial reports of chronic enteroviral infections causing debilitating symptoms in patients with CFS were met with skepticism, and largely forgotten for the past decade…….Recent evidence not only confirmed the earlier studies but also clarified the pathological role of viral RNA through antiviral treatment.

Ribavirin, interferon- [JR –pooled immunoglobulins early, choline + ascorbic acid.]

THE HEART AND ENTEROVIRUSES

Reetoo KN, Osman SA, Illavia SJ, Cameron-Wilson CL, Bantavala JE, Muir P. Quantitative analysis of viral RNA kinetics in coxsacchie B3- induce murine myocarditis….with persitence of residual viral RNA throughout and beyond the inflammatory phase. J Gen Virol 2000;81:2755-62

Lane RJM, Soteriou BA, Zhang H, Archard LC. Enterovirus related metabolic myopathy: a postviral fatigue syndrome. J Neurol Neurosurg Psychiatry 2003;74:1382-6.

Peckerman A, Lamanca JJ, Dahl KA, ChemitigantiR, Qureseishi B, Natelson BH. Abnormal Impedance Cardiography predicts Symptom Severity in Chronic Fatigue Syndrome. Am J Med Sci 2003;326:55-60.

Twisk & Maes, 2009.

Pall 2007

Klimas et al

Spence et al

This is the first time that raised levels of the gold standard measure of in vivo oxidative stress (isoprostanes) and their association with CFS symptoms have been reported.

McArdle et al FRBM 2005;39:651-7

Showing free radical (reactive oxygen species) increasing with exercise.

This is why GET is damaging to people with ME/CFS

They start with a high ROS load which is rapidly increased.

Part of strong evidence for ENCAPHALOMYELITIS vs NOT -OPATHY debate

Chronic Fatigue Syndrome: assessment of increased oxidative stress and altered muscle excitability in response to incremental exercise. Jammes et al J Intern Med 2005;257:299-310

In CFS there is

– increased oxygen uptake by exercising muscle

- exercise-induced oxidative stress was enhanced.

hsCRP correlates beset with clinical status of ME patients – Spence et al unpublished data

ME MANY SYMP

TOMS

Inflammation Cardiovascular Disease

Vance Spence et al

RNaseL Immune Dysregulation –Autoimmunity De Meirleir et al

Virus Susceptibility Enteroviruses Coxsacchie B Herpes EBV etc Richardson,

Chia, Lerner

COMPLEX

I LLNESS

PUPPET

MASTER

MANY STR I NGS

Cancer (Prostate,) Thyroid, NHL- Hyde

Genetics – Kerr et al, Gow et al

XMRV

XMRV SUMMARY SLIDE – ITS MAKES SENSE!

POLTICAL CONTROL OF HEALTH COSTS OF CHRONIC CONDITIONS AND CONCERNS OF INSURANCE INDUSTRY ABOUT COSTS REQUIRE M.E. TO BE DISMISSED BY FALSE EVIDENCE AND PATIENTS TO BE IGNORED.

POLICY-BASED EVIDENCE [PACING, CBT, GET] WITH NO CREDIBLE INTELLECTUAL OR CLINICAL FOUNDATION

VS

EVIDENCE-BASED POLICY [BIOMEDICAL WITH SOUND SCIENTIFIC FOUNDATION PROVIDING TARGETED HEALTH CARE &TREATMENT

FAILURE OF NATIONAL AND INTERNATIONAL HEALTH AND INSURANCE AGENCIES

53% 38% 9%

GP HOME VISITS

Never

Periodically

Regularly

VISIT THE SICK – DO NO HARM –MEDICAL NEGLIGENCE/DERELICITON OF DUTY

American Psychiatric Association’s Diagnostic and Statistical Manual for MENTAL DISORDERS, DSM –V. PROPOSED REVISION OF DSM 4

Excuse? RATIONALISE REVISION OF 1CD-10 TO ICD-11 categories of Mental Disorders with DSM.

NEW CATEGORY! COMPLEX SOMATIC SYMPTOM DISORDER, CSSD.

A. Somatic Symptoms- multiple & Distressing or ONE severe symptom

B. Misattributions, Excessive concerns or pre-occupation with symptoms and Illness.

At least 2 of

+ High level of health-related anxiety

+ Normal bodily symptoms are viewed as threatening and harmful.

+ Tendency to Assume Worst – catastrophising!

+ Belief in medical seriousness of their symptoms – despite contrary evidence

+ Health concerns assume a central role in their lives.

Examples Abound – Severe and persistent Gastric upset and pain – occasionally blood, vomiting- sometimes relieved by eating but some foods cause more pain. Feel weak and tired, worried. What is it?

M.E. (G93.3) is NOT a Mental and Behavioural Disorder (F48.0) –

repeat 3 times – morning, noon and night !- until THIS FALSE BELIEF clears.

IT IS FALSE ILLNESS BELIEF TO ASSERT M.E.HAS A PSYCHOGENIC ORIGIN

IT IS MEDICAL MALPRACTICE AND NEGLIGENCE [CRUEL AND PERVERSE]

1. NOT TO READ AND FULLY CONSIDER ALL THE BIOMEDICAL EVIDENCE ABOUT M.E. ( >4000 PEER-REVIEWED PAPERS). DATA, DATA, DATA- READ –MARK – LEARN – INWARDLY DIGEST – ACT IN THE LIGHT OF THIS KNOWLEDGE

2. TO DENY APPROPRIATE TESTS TO CONFIRM THE ILLNESS. NICE GUIDELINE IS USELESS, Gibson Report. Testing is not advised/ proscribed

3. TO USE SUCH WILFUL IGNORANCE TO LIMIT AND DENY APPROPRIATE TREATMENTS & INSURANCE BENEFITS.

1. THE NAME MUST BE CHANGED- DROP CFS AND ANY REFEENCE TO FATIGUE SYNDROME(S). KEEP ICD 11 G93.3 EXCLUDE FROM F48.0 & DSM V

2. EXPLORE OTHER POSSIBILITIES BASED ON BIOMEDICAL EVIDENCE eg. RETROVIRAL DISEASES Chap 0.?

THANK YOU FOR LISTENING