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

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2 CONTENTS Executive Summary, including summary of documented organic pathology……………………. 4 Introduction and source of information……………………………………………………………….. 7 The difference between ME/CFS and “CFS/ME”…………………………………………………….. 10 No cure for ME/CFS ……………………………………………………………………………………... 14 ME/CFS causes death ……………………………………………………………………………………. 15 Section 1: Background to the MRC PACE Trial……………………………………………………… 18 The Wessely School perspective ………………………………………………………………………… 18 The PACE Trial Principal Investigators (PIs) ………………………………………………………….. 30 Flawed studies by the Wessely School………………………………………………………………….. 36 The MRC secret files on CFS/ME……………………………………………………………………….. 44 The definition of CBT/GET used in the PACE Trial ………………………………………………….. 48 A “CBT model of CFS/ME”……………………………………………………………………………… 49 The troubling issue of CBT/GET as the sole intervention……………………………………………. 51 Dutch Report showing that CBT/GET is not helpful in ME/CFS…………………………………… 51 The Wessely School’s attempts to re‐classify ME/CFS as a mental disorder………………………. 53 The Wessely School’s attempts to reclassify IBS as a mental disorder………………………………. 56 The Wessely School’s attempts to reclassify fibromyalgia as a mental disorder…………………… 57 UNUMProvident’s policy that underlies the PACE Trial…………………………………………….. 60 The Woodstock connection………………………………………………………………………………. 60 Symptoms or sickness?…………………………………………………………………………………… 62 The ignoring of patients’ experience……………………………………………………………………. 75 Illustrations of patients’ experiences of psychiatric management…………………………………… 78 Illustrations of the effects of dissemination of misinformation………………………………………. 83 CFS/ME Clinical & Research Network Collaboration………………………………………………… 86 International experts’ concerns about CBT/GET in ME/CFS provided for the High Court ……... 88 Refusal of PIs to heed the biomedical science is causing increasing concern……………………….. 94 Section 2: Counter‐evidence: the biomedical basis of ME/CFS……………………………………. 98 ME/CFS is not “medically unexplained fatigue” ……………………………………………………... 99 Evidence that the Principal Investigators chose to ignore ……………………………………………. 106 Documented pathology in ME/CFS that contra‐indicates the use of GET………………………….. 110 Documented muscle abnormalities in ME/CFS……………………………………………………….. 111 Documented cardiovascular abnormalities in ME/CFS………………………………………………. 119 Documented neurological abnormalities in ME/CFS…………………………………………………. 139 Documented abnormalities shown on neuroimaging in ME/CFS…………………………………… 145 Documented neuroendocrine abnormalities in ME/CFS……………………………………………… 148 Documented evidence of inflammation in ME/CFS…………………………………………………… 151 Note on inflammation……………………………………………………………………………………... 154 Documented immune system abnormalities in ME/CFS……………………………………………… 155 Documented hair loss in ME/CFS……………………………………………………………………….. 170 Documented gastro‐intestinal abnormalities in ME/CFS……………………………………………... 171 Documented liver and spleen problems in ME/CFS…………………………………………….…….. 171 Documented respiratory abnormalities in ME/CFS…………………………………………………… 172 Documented abnormal gene expression in ME/CFS………………………………………………….. 173 Documented ocular abnormalities in ME/CFS………………………………………………………… 177 Documented involvement of viruses in ME/CFS……………………………………………………… 178 The role of viruses in ME/CFS…………………………………………………………………………… 192 Objective signs in ME/CFS……………………………………………………………………………….. 210 Documented signs and symptoms in ME/CFS………………………………………………………… 211 Documented international concerns about CBT/GET for patients with ME/CFS…………………. 214 Professor White’s Presentation in Bergen on 20 th October 2009………………………………………. 217 Defiance of science is rewarded in the UK……………………………………………………………… 221
Section 3: Consideration of the MRC PACE Trial…………………………………………………… 223 Misinformation in the PACE Trial literature …………………………………………………………… 223 Recruitment to the PACE Trial…………………………………………………………………………… 225 Apparent coercion to take part in the PACE Trial……………………………………………………… 228 Entry criteria ……………………………………………………………………………………………….. 231 Selection of participants …………………………………………………………………………………... 233 Key people involved are known to be “contentious” ………………………………………………….. 234 Involvement of Action for ME ……………………………………………………………………………. 234 Cost of the Trial (and cost‐effectiveness) ………………………………………………………………… 237 PIs’ reasons for Trial………………………………………………………………………………………... 239 PIs’ assumptions …………………………………………………………………………………………... 240 Inadequate subgrouping of trial cohort………………………………………………………………….. 240 Audio and video recordings to be made of participants………………………………………………. 241 Severe adverse events (SAEs)……………………………………………………………………………. 242 Predictors of outcome …………………………………………………………………………………….. 243 Chalder Fatigue Scale …………………………………………………………………………………….. 244 Analyses…………………………………………………………………………………………………….. 245 The intention to use the PACE Trial results to inform a revision of the NICE Guideline………….. 250 Undue influence on the PACE Trial outcome?………………………………………………………….. 251 MRC’s PR policy for PACE Trial and denial of any such policy……………………………………… 252 Confidentiality of data and failure to ensure it ………………………………………………………… 254 Theft of data ………………………………………………………………………………………………... 255 Conflicts of interest ………………………………………………………………………………………... 257 Cargo cult science? ………………………………………………………………………………………… 263 Conflicting information …………………………………………………………………………………… 263 Data‐gathering for non‐clinical purposes ……………………………………………………………….. 265 Insufficient testing of participants’ physical ability ……………………………………………………. 266 Known biases may not have been avoided ……………………………………………………………... 272 Apparent misrepresentation in the PACE Trial ………………………………………………………… 273 Blinding / unblinding……………………………………………………………………………………… 287 Apparent failure of PIs to adhere to the Declaration of Helsinki …………………………………….. 288 A cultural, not a medical, problem ………………………………………………………………………. 290 Many “Big Names” are involved with the PACE Trial………………………………………………… 291 UK/US interactions……………………………………………………………………………………….. 298 Abuse of process?………………………………………………………………………………………….. 302 Section 4: Quotations from the PACE Trial Manuals……………………………………………….. 316 Quotations from Therapists’ and Participants’ CBT Manuals………………………………………… 324 Quotations from Therapists’ and Participants’ GET Manuals………………………………………… 345 Quotations from Therapists’ and Participants’ APT Manuals………………………………………… 369 Consideration of SSMC (doctors’) Manual……………………………………………………………… 384 Conclusion (central issues of concern)………………………………………………………………… 394 The results of the trial can do little for people with ME/CFS…………………………………………. 403 Appendix I: Dr Tony Johnson ………………………………………………………………………. 409 Appendix II: Response to Dr Gabrielle Murphy, Royal Free Hospital………………………… 414 Appendix III: Dr Melvin Ramsay’s description of ME……………………………………………. 417 Appendix IV: The advent of UNUMProvident into the UK benefits system…………………… 418 Appendix V: Professor Mansel Aylward……………………………………………………………. 428 Appendix VI: Autopoiesis…………………………………………………………………………….... 429 Appendix VII: Tactics of Denial used by the Wessely School……………………………………… 434 Appendix VIII: Two FINE Trial Case Histories……………………………………………………...… 437 Appendix IX: International Clinical & Research Conferences & Books on ME/CFS………….. 440 3
Page 1: MAGICAL MEDICINE: HOW TO MAKE A DIS
Page 5 and 6: 5 MYALGIC ENCEPHALOMYELITIS/CHRONIC
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
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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
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439 After four months, Miss C’s h
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441 What an extraordinary claim: wh
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