MAGICAL MEDICINE: HOW TO MAKE AN ILLNESS ... - Invest in ME

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4 EXECUTIVE SUMMARY The Medical Research Council’s PACE Trial of behavioural interventions for Chronic Fatigue Syndrome / Myalgic Encephalomyelitis (CFS/ME) attracted considerable opposition from the outset and the Principal Investigators had difficulty in recruiting a sufficient number of participants. PACE is the acronym for Pacing, Activity, and Cognitive behavioural therapy, a randomised Evaluation, interventions that, according to one of the Principal Investigators, are without theoretical foundation. The MRC’s PACE Trial seemingly inhabits a unique and unenviable position in the history of medicine. It is believed to be the first and only clinical trial that patients and the charities that support them have tried to stop before a single patient could be recruited and is the only clinical trial that the Department for Work and Pensions (DWP) has ever funded. Since 1993, the giant US permanent health insurance company UNUMProvident has been advising the UK DWP about the most effective ways of curtailing sickness benefit payments. The PACE Trial is run by psychiatrists of the Wessely School, most of whom work for the medical and permanent health insurance industry, including UNUMProvident. These psychiatrists insist – in defiance of both the World Health Organisation and the significant biomedical evidence about the nature of it ‐‐ that “CFS/ME” is a behavioural disorder, into which they have subsumed ME, a classified neurological disorder whose separate existence they deny. Their beliefs have been repudiated in writing by the World Health Organisation. In 1992, the Wessely School gave directions that in ME/CFS, the first duty of the doctor is to avoid legitimisation of symptoms; in 1994, ME was described as merely “a belief”; in 1996 recommendations were made that no investigations should be performed to confirm the diagnosis and in 1999 patients with ME/CFS were referred to as “the undeserving sick”. There are legitimate concerns about the MRC PACE Trial that are centred on apparent coercion, exploitation of patients, contempt in which patients are held, manipulation, pretension, misrepresentation, flawed studies yielding meaningless results and lack of scientific rigour; the unusual personal financial interest of the Chief Investigator; the vested interests of the Principal Investigators; high rates of Severe Adverse Events (SAEs) and in particular, the underlying non‐clinical purpose of the trial, which seems to have the politically generated aim of removing patients from benefits (ie. the use of motivational behaviour therapy to achieve the intended result of the cessation of benefits for patients with “CFS/ME”). The Manuals used in the Trial seem to show that the authors either ignore medical science or they do not understand medical science. There is rightful objection to the denial of appropriate investigations and to the nationwide implementation of behavioural modification as the sole management strategy for the nosological disorder ME/CFS. That strategy is believed to be based on (i) the commercial interests of the medical and permanent health insurance industry for which many members of the Wessely School work and (ii) the dissemination of misinformation about ME/CFS by the Wessely School, whose members also act as advisors to UK Government agencies including the DWP, which it is understood has specifically targeted “CFS/ME” as a disorder for which certain State benefits should not be available. The Wessely School rejects the significant body of biomedical evidence demonstrating that chronic “fatigue” or “tiredness” is not the same as the physiological exhaustion seen in ME/CFS and persists in believing that they have the right to demand a level of “evidence‐based” definitive proof that ME/CFS is not an “aberrant belief” as they assert, when their biopsychosocial model of “CFS/ME” that perpetuates their own aberrant belief about the nature of ME/CFS has been exposed by other psychiatrists as being nothing but a myth. There are some extremely disquieting issues surrounding the MRC PACE Trial and documents obtained under the Freedom of Information Act allow the full story to be told for the first time.
5 MYALGIC ENCEPHALOMYELITIS/CHRONIC FATIGUE SYNDROME A review of biomedical clinical and research literature 1955-2006 (Substantial extracts from Prof. Malcolm Hooper’s submission to UK Parliamentary Inquiry, 2005) ME/CFS Society of Western Australia Facts: Myalgic Encephalomyelitis (ME) has been classified as a disorder of the central nervous system since 1969 – (World Health Organization International Classification of Diseases) WHO ICD 10 G 93.3 The renaming of ME to Chronic Fatigue Syndrome (CFS) in 1988, giving misplaced emphasis to “fatigue”, trivializes the substantial disability of the disease 1 – which can extend to the wheelchair or bed-bound requiring 24 hour care ME/CFS is characterized by neurological, immunological, gastrointestinal, cardiovascular and musculoskeletal features – severe forms can present with paresis, seizures, intractable savage headaches and life threatening complications Amorphous definitions and diagnostic symptom criteria have contaminated study cohorts and corrupted research data 2-10 – researchers and clinicians participating in the 2005 Adelaide ME/CFS Research Forum unanimously endorsed the adoption of the acclaimed 2003 Canadian Clinical Criteria ME/CFS may include clinical syndromes linked to infectious agents and toxic exposures 11-15 – incl. Epstein Barr virus, ciguatoxin 13, organophosphates and organochlorines 12,14 Prevalence estimates are 235-700 per 100,000 affecting all socio-economic and ethnic groups, and men and women of all ages 16-21 – more prevalent than AIDS, lung or breast cancer 19 Disease impact 22-26 – quality of life equivalent to late stage AIDS 17,27, chronic obstructive lung 25,28 and heart disease and end stage renal failure 29 Some experience recovery (average 7yrs17), some partially recover and a significant proportion (25% 20) are permanently incapacitated 17-20,22-23 Biomedical Abnormalities: Immune System, including: • chronic immune activation and dysfunction 24,30-32 evidence of persistent viral infection 33 (enteroviral 34-41, EBV 42-47 and HHV-6/7 43,45-50), activation of the 2-5A anti-viral pathway 47,51-56, low natural killer cells and cytotoxicity 33,47,54,57-63, T-cell abnormalities 59,61-62,64-66, pro-inflammatory cytokines and inflammation 66-72, increased cell apoptosis (death) 73-74 and allergy 54,75-77 • abnormal immuno-genetic expression 61,66,78-81 Brain/Central Nervous System, including: • objective measurement of dysfunction 54,82-86 –deficits in working memory, concentration, information processing 87-95, autonomic function 96-98 (incl. neurally mediated hypotension and orthostatic intolerance) • abnormalities –regional brain hypoperfusion 99-106 by SPECT, white and gray matter abnormalities 106-112 by MRI, inflammation 66,106-107,113-114, hypomyelination 83,113-114, neurotransmitter 115-116,119 and metabolic dysfunction 117-121 by MRS/PET and abnormal spinal fluid proteins 122-123 • abnormal neuro-genetic expression 114 Endocrine System: impaired activation of the hypothalamic-pituitary-adrenal (HPA) axis 124-131 and abnormalities of neuroendocrine-genetic expression 78 Heart and Circulatory System: hypoperfusion 54,83,99-106,132-136, impaired vascular control 27,134-137 (incl. abnormal response to acetylcholine), low blood volume 134-135, vasculitis 136-137 (incl. raised oxidative stress, inflammation and arterial stiffness 138-139) and heart dysfunction 132,135,140-141 Muscular: structural and biochemical abnormalities 38,68,89,142-148 including impaired muscle recovery after exercise 149-154 (exercise responsive gene expression abnormal, worsening after exercise 155) Others: gastrointestinal dysfunction 156-158 including food intolerance 159-160 and IBS 156,161, mitochondrial dysfunction 38,82,125,162-163 including abnormal mitochondrial associated gene expression 164 and ion transport channelopathy 155,165-166
Page 1 and 2: MAGICAL MEDICINE: HOW TO MAKE A DIS
Page 3: Section 3: Consideration of the MRC
Page 7 and 8: Introduction MAGICAL MEDICINE: HOW
Page 9 and 10: 9 associations purely in order to
Page 11 and 12: 11 “It’s not an illness that pe
Page 13 and 14: 13 release that is not found in hea
Page 15 and 16: 15 “The second clinical implicati
Page 17 and 18: 17 In January 2003 the wife of Rich
Page 19 and 20: 19 biomedical aspects of ME/CFS wer
Page 21 and 22: “Social factors 21 “Several of
Page 23 and 24: 23 Despite the substantial evidence
Page 25 and 26: 25 as possessed by devils or spirit
Page 27 and 28: 27 However, as Crombez G et al poin
Page 29 and 30: 29 Professor Anthony David’s resp
Page 31 and 32: 31 From these beliefs of the PACE T
Page 33 and 34: 33 warning about dependence being e
Page 35 and 36: 35 This is unequivocal: according t
Page 37 and 38: 37 Those studies, however, have bee
Page 39 and 40: 39 The answer may be found in the f
Page 41 and 42: 41 than giving actual numbers of pa
Page 43 and 44: 43 deconditioning caused their illn
Page 45 and 46: 45 Legitimate access has been obtai
Page 47 and 48: 47 Goldstein’s search took a litt
Page 49 and 50: 49 says about GET: “GET will be b
Page 51 and 52: 51 The whole concept of “a CBT mo
Page 53 and 54: 53 International concern about the
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55 The CISSD project was the brainc
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57 are changed in IBS lends credibi
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59 (http://www.entretiens‐du‐ca
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61 As Jonathan Rutherford, now Prof
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63 There are many who would profoun
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65 The term “CFS/ME” was carefu
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67 ill‐health and disability is d
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69 “The sick role does have advan
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71 Such is the influence of the Wes
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73 Editors of broadsheet newspapers
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75 Collins J who found that the UK
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77 The “Invitation to join the PA
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79 On 10 June 1988 Wessely provided
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81 “There is a record of a confid
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83 (6) Another, more recent illustr
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85 psychological hypotheses of caus
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87 Of particular note are the follo
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89 • “Two forms of treatment…
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91 patients with chronic fatigue st
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93 • Another UNUM policyholder, A
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95 “Over the twenty years I have
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97 a functional somatic syndrome),
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99 protein and serum amyloid A (whi
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101 their cortisol response, in tha
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103 exposures. Responsibility for t
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105 illness (and) these biases have
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107 diagnoses before (ME)CFS onset,
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109 He noted that: “The most extr
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111 According to Professor Nancy Kl
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113 95% have abnormal cognitive‐e
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115 In 2003 a UK study of skeletal
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117 “ME/CFS describes a disorder
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119 proposed for treatment‐resist
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121 page 381: “Arrhythmias are fr
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1995 123 “The use of cardiopulmon
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1999 125 “This study examined the
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127 cardiac output. This present st
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2005 129 On 10 th April 2005 Carol
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131 The next system to be compromis
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2005 133 Researchers at the US Cent
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135 In ME/CFS, these serious issues
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137 confirms reduced functional cap
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139 haemodynamics and an increased
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141 perhaps all, of the symptoms of
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2000 143 In 2000, the CFIDS Associa
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145 includes haemodynamic assessmen
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2003 147 German researchers Siessme
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149 producing any evidence of damag
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151 English and Australian reports
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2006 153 “(ME)CFS is a poorly def
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155 These recommendations note that
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1990 157 “In order to characteris
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1994 159 “The chronic fatigue imm
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161 symptoms not currently in the C
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1999 163 An article from researcher
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2003 165 “(ME)CFS is an increasin
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167 Commenting on this paper, Dr Ne
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2007 169 “For decades, (ME)CFS pa
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171 Documented abnormalities in the
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1996 173 De Lorenzo et al noted tha
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175 identifying biomarkers…It is
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177 analysed the gene expression in
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1955 179 Acheson described and comp
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181 (In the light of the discovery
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183 psychiatric symptoms…as commo
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185 The presence of the LMW RNase L
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187 to investigating the bioavailab
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189 the blood of patients with AIDS
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191 displayed by (ME)CFS patients.
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193 Moreover, recent research has s
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195 In August 1991, together with c
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197 “The data do not support the
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199 Lerner Research Institute who i
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201 It is regrettable that the UK M
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203 Notably, Dr Stuart Le Grice, he
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205 that the majority of patients f
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207 “Just because one is blessed
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209 They would do well to remember
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211 itself said at the time: “stu
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213 muscle, endocrine and lymphoid
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215 “ ‘I don’t take the Briti
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217 “This is a major concern give
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219 “The availability of sensitiv
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221 impinge upon medical decisions
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SECTION 3: Consideration of the MRC
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225 such as multiple sclerosis in w
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227 of 600 participants. Issue 3 of
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229 Dr Gabrielle Murphy is/was part
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231 trials…are open to the charge
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233 Given that the Oxford criteria
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235 maximised by the collaboration
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237 c) I had been told by Dr. X (th
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The Investigators’ Reasons for th
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241 In his presentation entitled
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243 Peter White, however, asserted
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245 To many people, it is incompreh
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247 In her communication of 16 th J
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249 a) emotional lability….b)…d
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Undue influence on the PACE Trial o
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253 Pensions) and copied to the PAC
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255 only one database. This will be
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257 Conflicts of interest of those
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259 • a copy of the original prop
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261 There is another curious aspect
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Fraudulent research (Cargo cult sci
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265 It seems that, in comparison wi
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267 Initially, the Trial Investigat
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269 Information on other abnormalit
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271 It is notable that advising exe
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273 “Outcome choice bias: Sometim
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275 say that they have physical sym
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277 consent requires that the parti
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279 If in the PACE Trial the Wessel
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281 “Enhanced negative‐feedback
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283 health problem. There is no des
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The Handbook continues: 285 “Main
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287 Mark Seddon, a member of Labour
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289 Section B covers “Basic princ
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291 To combine all states of “med
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293 PACE Trial includes those who d
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295 • “People who present with
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297 • have succeeded in making cl
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299 White treating this as a purely
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301 “ Attempting to come to a con
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303 “CFS/ME” on State benefits
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305 segments of the medical establi
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307 could he require Primary Care T
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309 The Judge said: “The ‘psych
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311 they so desperately need and de
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313 condition that is seen by many
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315 17 th July: 1‐8 (Epub ahead o
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317 The APT Manual for Participants
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319 defining feature of ME/CFS (the
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321 PACE Trial participants and the
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323 Despite the fact that this was
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325 was available even before the p
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327 Physical factors, such as infec
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329 someone to change their fundame
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331 “A purely physical attributio
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333 “Therapist: I can understand
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335 On page 12 the authors state:
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337 However, as Chief Investigator,
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339 • “In all individuals, musc
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341 consistent with the assumption
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343 “6. The ‘wrong’ kind of s
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Quotations from the Therapists’ M
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347 Bavinton, Clark and White discu
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349 In the section of the GET Manua
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351 to be a consequence “of too m
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353 Phase 3 (page 54 of the Manual)
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355 going viral infection); should
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Quotations from the Participants’
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359 increase in bone density; think
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361 The authors summarise their adv
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363 Next comes a section on the Bor
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365 Such advice seems culpable. It
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Comments from someone who has under
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Quotations from the Therapists’ M
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371 doing at the time); there must
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373 are the “solutions” that ar
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375 The section beginning on page 4
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377 Three months after the end of s
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379 Participants were to be given a
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“Budgeting Energy: � Evaluating
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Comments by participants in the PAC
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385 Page 5 of the SSMC Manual infor
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387 illness is non‐biological…
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389 • have the main symptom of fa
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391 dispute/negotiation of benefits
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393 Appendix 6: Summary of Therapie
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395 There can be no doubt that, for
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397 evidence for a specific persist
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399 To imply that patients can reco
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401 (8) The Investigators did not i
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403 (15) The Investigators and some
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405 ME/CFS have reduced blood volum
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407 PACE Trial is about “Health e
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409 APPENDIX I: Dr Tony Johnson, De
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411 “I have advised many clinical
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413 “Fibromyalgia patients are in
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415 who do not agree to take part i
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417 Appendix III: Dr Melvin Ramsay
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419 • “It is not only people in
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421 “It will be imperative that h
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423 “It is important to understan
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425 with what look like exhaustive
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427 To date, MPs’ postbags contin
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429 APPENDIX VI: The Wessely’ Sch
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431 They explain that historically,
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433 Why would two PACE Trial Princi
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435 • deniers engage in “comple
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APPENDIX VIII: Two FINE Trial Case
Page 439 and 440:
439 After four months, Miss C’s h
Page 441 and 442:
441 What an extraordinary claim: wh
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