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

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Introduction MAGICAL MEDICINE: HOW TO MAKE A DISEASE DISAPPEAR The Medical Research Council’s PACE Trial of certain “behavioural modification” interventions for patients with Chronic Fatigue Syndrome / Myalgic Encephalomyelitis (CFS/ME) is controversial on many levels. “PACE” is the acronym for “Pacing, Activity, and Cognitive behaviour therapy; a randomised Evaluation”. The PACE trial is being conducted under the auspices of the Medical Research Council (MRC) and is funded by the MRC, the Scottish Chief Scientist’s Office, the Department of Health (DoH) and the Department for Work and Pensions (DWP). The PACE Trial is the only clinical trial that the DWP has ever funded. 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 which support them have tried to stop before a single patient could be recruited. Why would people with a severely disabling disease ‐‐ a disease that manifests the pathology summarised on the preceding two pages ‐‐ seek to stop research into their own condition? To answer this question it is necessary to understand the motives of the trial researchers – a group of UK psychiatrists and their adherents who advise that the search for a single identifiable cause is meaningless and whose stated aim is to “eradicate” Myalgic Encephalomyelitis, a disease that has been classified by the World Health Organisation (WHO) in the International Classification of Diseases (ICD) as a neurological disorder for the last 40 years, currently under Disorders of Brain at ICD‐10 G93.3 (to which in ICD‐10 the WHO specifically codes “chronic fatigue syndrome” (CFS), hence the use of the term ME/CFS to signify the neurological disease ME). This is a classification with which these psychiatrists disagree. Instead, they believe ME/CFS (which they call “CFS/ME”) to be a behavioural disorder that is classified as a “fatigue” syndrome in ICD‐10 at F48.0 under Mental and Behavioural Disorders and that it is perpetuated by the “aberrant beliefs” of the patients themselves, and they seek to modify such aberrant beliefs using a programme of Cognitive Behavioural Therapy (CBT) designed by themselves, which incorporates aerobic Graded Exercise Therapy (GET). These psychiatrists and their supporters, many of whom work for the medical and permanent health insurance industry, are known as the “Wessely School” (Hansard: Lords: 9 th December 1998:1013), a small but influential group led by Professor Simon Wessely from King’s College Hospital and the Institute of Psychiatry (IoP), London, whose intention is said to be to “eradicate” ME (Eradicating “Myalgic Encephalomyelitis”. Pfizer/Invicta: 4‐5 /LINC UP, 15 th April 1992, Belfast Castle) by dropping “ME” from “CFS/ME” when expedient (BMJ 2003:326:595‐597) and then to reclassify “CFS” as a behavioural disorder under syndromes of chronic “fatigue” under Mental and Behavioural Disorders at ICD‐10 F48.0. Indeed, this has already commenced because, using Wessely’s own material, in 2000 the first edition of the IoP’s “Guide to Mental Health in Primary Care” included “CFS/ME” as a mental disorder. (This Guide was wrongly described by Ministers of State as the “WHO Guide” because as an acknowledged WHO Collaborating Centre on mental health, the IoP is entitled to use the WHO logo). In September 2001, the WHO issued a statement repudiating the unofficial re‐classification by the UK Collaborating Centre at the IoP, saying that it was at variance with the WHO’s position. An erratum to the Guide had to be issued, but only after 30,000 copies had been sold. The matter was raised in Parliament on 22 nd January 2004, when Earl Howe noted that Professor Wessely had: “effectively hijacked the WHO logo to give credence to his own view of ME as a mental illness” (Hansard: Lords: 23 rd January 2004:656:7:1192).
Page 1 and 2: MAGICAL MEDICINE: HOW TO MAKE A DIS
Page 3 and 4: Section 3: Consideration of the MRC
Page 5: 5 MYALGIC ENCEPHALOMYELITIS/CHRONIC
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
Page 55 and 56: 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…
Page 91 and 92:
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
Page 97 and 98:
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
Page 107 and 108:
107 diagnoses before (ME)CFS onset,
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109 He noted that: “The most extr
Page 111 and 112:
111 According to Professor Nancy Kl
Page 113 and 114:
113 95% have abnormal cognitive‐e
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115 In 2003 a UK study of skeletal
Page 117 and 118:
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
Page 127 and 128:
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
Page 141 and 142:
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
Page 167 and 168:
167 Commenting on this paper, Dr Ne
Page 169 and 170:
2007 169 “For decades, (ME)CFS pa
Page 171 and 172:
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
Page 179 and 180:
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
Page 187 and 188:
187 to investigating the bioavailab
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189 the blood of patients with AIDS
Page 191 and 192:
191 displayed by (ME)CFS patients.
Page 193 and 194:
193 Moreover, recent research has s
Page 195 and 196:
195 In August 1991, together with c
Page 197 and 198:
197 “The data do not support the
Page 199 and 200:
199 Lerner Research Institute who i
Page 201 and 202:
201 It is regrettable that the UK M
Page 203 and 204:
203 Notably, Dr Stuart Le Grice, he
Page 205 and 206:
205 that the majority of patients f
Page 207 and 208:
207 “Just because one is blessed
Page 209 and 210:
209 They would do well to remember
Page 211 and 212:
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
Page 221 and 222:
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
Page 229 and 230:
229 Dr Gabrielle Murphy is/was part
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231 trials…are open to the charge
Page 233 and 234:
233 Given that the Oxford criteria
Page 235 and 236:
235 maximised by the collaboration
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237 c) I had been told by Dr. X (th
Page 239 and 240:
The Investigators’ Reasons for th
Page 241 and 242:
241 In his presentation entitled
Page 243 and 244:
243 Peter White, however, asserted
Page 245 and 246:
245 To many people, it is incompreh
Page 247 and 248:
247 In her communication of 16 th J
Page 249 and 250:
249 a) emotional lability….b)…d
Page 251 and 252:
Undue influence on the PACE Trial o
Page 253 and 254:
253 Pensions) and copied to the PAC
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255 only one database. This will be
Page 257 and 258:
257 Conflicts of interest of those
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259 • a copy of the original prop
Page 261 and 262:
261 There is another curious aspect
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Fraudulent research (Cargo cult sci
Page 265 and 266:
265 It seems that, in comparison wi
Page 267 and 268:
267 Initially, the Trial Investigat
Page 269 and 270:
269 Information on other abnormalit
Page 271 and 272:
271 It is notable that advising exe
Page 273 and 274:
273 “Outcome choice bias: Sometim
Page 275 and 276:
275 say that they have physical sym
Page 277 and 278:
277 consent requires that the parti
Page 279 and 280:
279 If in the PACE Trial the Wessel
Page 281 and 282:
281 “Enhanced negative‐feedback
Page 283 and 284:
283 health problem. There is no des
Page 285 and 286:
The Handbook continues: 285 “Main
Page 287 and 288:
287 Mark Seddon, a member of Labour
Page 289 and 290:
289 Section B covers “Basic princ
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291 To combine all states of “med
Page 293 and 294:
293 PACE Trial includes those who d
Page 295 and 296:
295 • “People who present with
Page 297 and 298:
297 • have succeeded in making cl
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299 White treating this as a purely
Page 301 and 302:
301 “ Attempting to come to a con
Page 303 and 304:
303 “CFS/ME” on State benefits
Page 305 and 306:
305 segments of the medical establi
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307 could he require Primary Care T
Page 309 and 310:
309 The Judge said: “The ‘psych
Page 311 and 312:
311 they so desperately need and de
Page 313 and 314:
313 condition that is seen by many
Page 315 and 316:
315 17 th July: 1‐8 (Epub ahead o
Page 317 and 318:
317 The APT Manual for Participants
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319 defining feature of ME/CFS (the
Page 321 and 322:
321 PACE Trial participants and the
Page 323 and 324:
323 Despite the fact that this was
Page 325 and 326:
325 was available even before the p
Page 327 and 328:
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
Page 335 and 336:
335 On page 12 the authors state:
Page 337 and 338:
337 However, as Chief Investigator,
Page 339 and 340:
339 • “In all individuals, musc
Page 341 and 342:
341 consistent with the assumption
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343 “6. The ‘wrong’ kind of s
Page 345 and 346:
Quotations from the Therapists’ M
Page 347 and 348:
347 Bavinton, Clark and White discu
Page 349 and 350:
349 In the section of the GET Manua
Page 351 and 352:
351 to be a consequence “of too m
Page 353 and 354:
353 Phase 3 (page 54 of the Manual)
Page 355 and 356:
355 going viral infection); should
Page 357 and 358:
Quotations from the Participants’
Page 359 and 360:
359 increase in bone density; think
Page 361 and 362:
361 The authors summarise their adv
Page 363 and 364:
363 Next comes a section on the Bor
Page 365 and 366:
365 Such advice seems culpable. It
Page 367 and 368:
Comments from someone who has under
Page 369 and 370:
Quotations from the Therapists’ M
Page 371 and 372:
371 doing at the time); there must
Page 373 and 374:
373 are the “solutions” that ar
Page 375 and 376:
375 The section beginning on page 4
Page 377 and 378:
377 Three months after the end of s
Page 379 and 380:
379 Participants were to be given a
Page 381 and 382:
“Budgeting Energy: � Evaluating
Page 383 and 384:
Comments by participants in the PAC
Page 385 and 386:
385 Page 5 of the SSMC Manual infor
Page 387 and 388:
387 illness is non‐biological…
Page 389 and 390:
389 • have the main symptom of fa
Page 391 and 392:
391 dispute/negotiation of benefits
Page 393 and 394:
393 Appendix 6: Summary of Therapie
Page 395 and 396:
395 There can be no doubt that, for
Page 397 and 398:
397 evidence for a specific persist
Page 399 and 400:
399 To imply that patients can reco
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401 (8) The Investigators did not i
Page 403 and 404:
403 (15) The Investigators and some
Page 405 and 406:
405 ME/CFS have reduced blood volum
Page 407 and 408:
407 PACE Trial is about “Health e
Page 409 and 410:
409 APPENDIX I: Dr Tony Johnson, De
Page 411 and 412:
411 “I have advised many clinical
Page 413 and 414:
413 “Fibromyalgia patients are in
Page 415 and 416:
415 who do not agree to take part i
Page 417 and 418:
417 Appendix III: Dr Melvin Ramsay
Page 419 and 420:
419 • “It is not only people in
Page 421 and 422:
421 “It will be imperative that h
Page 423 and 424:
423 “It is important to understan
Page 425 and 426:
425 with what look like exhaustive
Page 427 and 428:
427 To date, MPs’ postbags contin
Page 429 and 430:
429 APPENDIX VI: The Wessely’ Sch
Page 431 and 432:
431 They explain that historically,
Page 433 and 434:
433 Why would two PACE Trial Princi
Page 435 and 436:
435 • deniers engage in “comple
Page 437 and 438:
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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