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THE PACE TRIAL – 3Ts OF CRITICISM TRAVESTY OF SCIENCE TRAGEDY FOR PATIENTS/CARERS TANTAMOUNT TO FRAUD Malcolm Hooper PhD, B Pharm, MRIC, C Chem Professor.

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Presentation on theme: "THE PACE TRIAL – 3Ts OF CRITICISM TRAVESTY OF SCIENCE TRAGEDY FOR PATIENTS/CARERS TANTAMOUNT TO FRAUD Malcolm Hooper PhD, B Pharm, MRIC, C Chem Professor."— Presentation transcript:

1 THE PACE TRIAL – 3Ts OF CRITICISM TRAVESTY OF SCIENCE TRAGEDY FOR PATIENTS/CARERS TANTAMOUNT TO FRAUD Malcolm Hooper PhD, B Pharm, MRIC, C Chem Professor of Medicinal Chemistry, University of Sunderland

2 A TRAVESTY OF SCIENCE

3 ALL IS NOT FINE WITH THE PACE TRIAL SAME PRE-DETERMINED PRIMARY OUTCOME MEASURES BASED ON PHYSICAL FUNCTIONING - SF-36 SUBSCALE FATIGUE – Chalder Bimodal Fatigue Scale

4 FINE CONCLUSIONS- …..the effect is small and not statistically significant at one year followup…….. CBT/GET, AS MEASURED BY THESE PARAMETERS IS NOT EFFECTIVE IN TREATING OR MANAGING CFS/ME PRIMARY OUTCOMES SF-36 SCORE - 75% OR MORE - ENTRY 70% OR LESS FATIGUE CHALDER SCALE 3 OR LESS - ENTRY 4 OR MORE

5 PACE SF-36 SCORE – ENTRY 60,65, (11) 65* 70 SF-36 SCORES – OUTCOMES –NORMAL RANGE +/- 1 SD % A. W.A.ALL A.A.

6 CHALDER FATIGUE 11-PONT BIMODAL SCALE ENTRY – 4 OR MORE LATER RAISED TO 6 POINTS TO AVOID ONLY TRIVIAL DIFFERENCES – [3 OR LESS NORMAL FATIGUE] OUTCOMES- DATA COLLECTED USING CF BIMODAL SCALE ANALYSIS NOT DONE –DATA EXPRESSED AS LIKERT SCALE- A 33 POINT SCALE WHICH DOES NOT SIMPLY RELATE TO CF SCALE BUT CLAIMED TO IDENTIFY SMALL DIFFERENCES FINE – data had been re-analysed by Likert found clinically modest but statistically significant effect on fatigue [but no effect on physical functioning.]

7 REVISED OUTCOMES - INTERCONVERSION CHALDER LIKERT 4 8 – – ON LIKERT SCALE ALWAYS INDICATES ABNORMAL FATIGUE; EQUATES TO CHALDER 4, 5, 6 … 9. ENTRY LEVELS FOR FATIGUE IN ‘THE NORMAL RANGE’ MAY BE HIGHER THAN LEVEL AT ENTRY INTO THE TRIAL. SOME PEOPLE MAY HAVE DETERIORATED AT THE END OF THE TRIAL – CONFUSION WORSE CONFOUNDED

8 WHAT IS NORMAL? –A KEY QUESTION THAT NEEDS TO BE ADDRESSED. THREE “NORMATIVE” DATA BASES USED 1.ALL ADULT SF- 36 VALUES PHYSICAL FUNCTION 2.ALL WORKING ADULT WORKING POPULATION SF-36 VALUES 3.ADULT ATTENDEES AT GENERAL PRACTICES IN UK [MEASURED 1 YEAR PRIOR TO PACE TRIAL] NO CONSIDERATION OF CONSEQUENCES OF KNOWN HEAVILY SKEWED DATA FOR SF-36 DATA. IF FATIGUE IS NORMALLY DISTRIBUTED IN THE POPULATION IT IS THE ONLY HEALTH STATUS INDICATOR THAT IS –NEEDS FURTHER COMMENT.

9 NO DISCUSSION OF PRE-DETERMINED ‘PRIMARY IN RELATIONSHIP TO EFFICACY MEASURES’ TO THE OUTCOME DATA IN LANCET PAPER AN INDEPENDENT STATISTICAL ANALYSIS OF ALL THE RAW DATA GENERATED IN THE TRIAL IS ESSENTIAL TO ADDRESS THESE AND MANY OTHER FUNDAMENTAL CRITICISMS

10 Other major comments COMPARISON BETWEEN THE 4 GROUPS CBT ALONE – 30% (14) GET ALONE -28% (12) ADAPTIVE PACING - 16% SSMC - 15% AT BEST THIS CAN ONLY BE REGARDED AS A MODEST GAIN FROM CBT AND GET THERE WAS NO CONTROL GROUP – AGE/SEX MATCHED THE TRIAL WAS NOT A RANDOMISED CONTROLLED TRIAL AS PROPOSED.

11 THERE WAS NO OBJECTIVE DATA – MAKING THE TRIAL DATA ANECDOTAL!! THE WALKING TEST AT END OF TRIAL REPLACED THE ONLY OBJECTIVE MEASURE- ACTIGRAPHY – AND WAS SO BADLY PERFORMED THAT IT WAS USELESS. THE DISTANCE WALKED BY ALL GROUPS < THAN PEOPLE WHO ARE ILL WITH COPD, TBI, THE ELDERLY. CBT GROUP < SMC AN OBJECTIVE TEST WAS AVAILABLE FROM PDW’S OWN WORK ON TNF-ALPHA. THIS ALSO INDICATED THE DELAYED EFFECTS OF POST-EXERTIONAL MALAISE. White et al JCFS 2004;12:57-66.

12 POST-EXERTIONAL MALAISE – THE CARDINAL SIGN OF M.E. WAS NOT A NECESSARY CRITERION FOR CFS/ME OXFORD CRITERIA DESCRIBES ONLY IDIOPATHIC FATIGUE – WHATEVER ITS ORIGIN. THE LONDON CRITERIA – NEVER VALIDATED- WERE USED TO CREATE A NEW VERSION THAT WAS SUITED TO THE AIMS OF THE STUDY. ADAPTIVE PACING IS NOT PACING AS COMMONLY USED AND FOUND HELPFUL BY THE M.E. COMMUNITY. IT INVOLVES STRUCTURED EXERCISE (GET?) AND ITS FAILURE MAY REFLECT THAT.

13 FACTUALLY INCORRECT – WHO ICD-10 MAKES CFS AND ME EQUIVALENT TERMS IN G.93.3; NEUROLOGICAL CONDITIONS “The PACE trial paper refers to chronic fatigue syndrome (CFS) which is operationally defined; it does not purport to be studying CFS/ME”. PDW – letter to Editor of Lancet FACTUALLY INCORRECT – VIRTUALLY ALL, THE 2000 PAGES, OF TRIAL DOCUMENTATION REFER TO CFS/ME This gives the game away – the whole trial was designed to justify the labelling of ME (a neurological condition) as CFS (a mental and behavioural, somatoform disorder).

14 OVER ALL THE TRIAL, DATA AND ANALYSIS ARE CONFUSED, CONVOLUTED, CONTRADICTORY, MISREPRESENTATIVE. MANIPULATION OF BENCHMARKS LEADS TO AN ABSURD SITUATION WHERE THE SAME OR LOWER ENTRY SCORE IS DEEMED TO REPRESENT A SUCCESSFUL OUTCOME. THE SERIOUSLY FLAWED TRIAL ATTEMPTS TO JUSTIFY THE PSYCHIATRIC VIEW OF CFS/ME ONLY A ‘ROOT & BRANCH’ INDEPENDENT ANALYSIS OF ALL THE RAW DATA WILL CLARIFY THESE ISSUES. IT IS URGENTLY NEEDED. MEANWHILE ALL CONCLUSIONS DRAWN FROM THE TRIAL MUST BE PUBLICLY RESCINDED IN THE SCIENTIFIC LITERATURE, POPULAR MEDIA, DWP, MRC, NICE, GOVERNMENT & BENEFITS/INSURANCE INDUSTRY.

15 A TRAGEDY FOR PATIENTS DENIED APPROPRIATE MEDICAL CARE (25% Group) REGARDED AS DELUDED (FALSE ILLNESS BELIEF) SPOILT CHILDREN LAZY (S Wessely) SUBJECT TO THE MANTRA DO NOT LISTEN TO YOUR OWN BODY’S SIGNALS DO NOT TRUST YOUR OWN FEELINGS DO NOT TRUST YOUR OWN THOUGHTS (Wilhelmsen 2005) BENEFITS WILL BE CHALLENGED, REMOVED OR SIGNIFICANTLY REDUCED SECTIONING UNDER MENTAL HEALTH ACT (ADULTS/CHILDREN, MSBP) MANY FALSE AND MISSED DIAGNOSES

16 “NEVER IN THE FIELD OF MODERN MEDICINE HAS SO MUCH HARM BEEN DONE TO SO MANY BY SO FEW”. MYALGIC ENCEPHALOMYELITIS Dr Irving Spurr Liverpool ME Seminar 2011

17 NICE GUIDELINE – “UNFIT FOR PURPOSE” – WILL CONTINUE UNCHALLENGED AND DESTRUCTIVE ADVICE WILL BE SENT OUT TO PATIENTS & DOCTORS ….interventions recommended in the original guideline, such as CBT and GET, were described as the interventions for which there is the clearest evidence-base of benefit. This is supported by the recently published PACE trial….The results of the study are in line with current NICE guideline recommendations on the management of CFS/ME….There are no factors…which would invalidate or change the direction of the current guideline recommendations. The CFS/ME guideline should not be updated at this time”. “The PACE findings can be generalised to patients who also meet alternative diagnostic criteria for chronic fatigue syndrome and myalgic encephalomyelitis but only if fatigue is their main symptom”. Lancet 2011

18 IT DOES NOT DO WHAT IT SAYS ON THE TIN TANTAMOUNT TO FRAUD

19 NOT A RANDOMISED CONTROLLED TRIAL NO ENGAGEMENT WITH PRE-DETERMINED PRIMARY EFFICACY MEASURES. ONLY SECONDARY MEASURES. NO OBJECTIVE DATA – ONLY SUBJECTIVE REPORTING. Failed to provide “high quality evidence” promised ”The world cannot be divided into ‘the ill’ and the ‘well’ on the basis of the degree of Fatigue.” S.Wessely, 1998 FINE and PACE STUDIES are predicated on this possibility. If this was acknowledged in 1998 then why were the FINE and PACE studies funded at >£6million along with the Fatigue Clinics – this is not value for money!

20 Science, Medicine, people and money have been sacrificed in an ideological attempt to impose a false understanding of the illness. The media, popular, scientific and medical have been prostituted by the grandiose presentation of the trial “results”, media spin, and attempts to disallow any criticism of the Trial. Reminiscent of totalitarian regimes which Britain claims to abhor. To witness so many in a once respected occupation so easily being made to look foolish by psychiatric creationism suggests strongly that perhaps one wouldn't even need to be able to think for oneself in order to practice medicine in the UK - a rather frightening situation for us all. Dr from Australia

21 SOMATISATION PAR EXCELLENCE [Hysteria] “CAUSATION FORGET IT!!!!” CFS PATHWAY PANEL- courtesy of Dr Spurr

22 WHAT DO YOU THINK OF PACE TRIAL,NHS TREATMENT AND NICE GUIDELINES? RUBBISH!! Courtesy of Dr Irving Spurr, 2011

23 ME – A CHRONIC, PROGRESSIVE, COMPLEX, MULTI-SYSTEM ILLNESS MULTIPLE SYMPTOMS CV, CNS, ANS, IMMUNE, ENDOCRINE EV HERPES OTHER VIRUSES VACCINES CHEMICALS TBI INTRACELLULAR ORGANISMS. LYME, Q-FEVER, MYCOPLASMAS, CHLAMYDIA ME-LIKE SYMPTOMS MIXTURE OF SUB- GROUPS

24 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 COMPLEXILLNESSCOMPLEXILLNESS MANY INSULTSTMANY INSULTST Cancer (Prostate) Thyroid, NHL Hyde Genetics – Kerr et al, Gow et al Proteomics –Schutzer, Kogelnik SUMMARY SLIDE – ITS MAKES SENSE!

25 Hypothesis ABCDEFGHIJKABCDEFGHIJK Final common pathway(s ) CFS/ME Insults Initial processes Courtesy of Jonathan Kerr JID 2008

26 PROTEOMICS Separation of proteins in CSF in Neurologic post treatment Lyme Disease and ME-CSF patients Schutzer et al 2011

27 TREATMENT. [ ACUTE/CHRONIC PHASE]. How do I achieve and maintain*Improvement* EARLY DIAGNOSIS. Hospital or Home MINIMAL ACTIVITY. Rest sick cells STRESS REDUCTION. Home tuition. Flexi-hours. Benefit payments. IMMUNE REGULATION with IGG Defer Pregnancy. “Grandma’s Organic Cooking” CHOLINE/VITC

28 WHICH OF THESE TWO CAN HAVE A ROUTINE TEST FOR VP1 – ENTEROVIRUS MARKER

29 TREATMENTS VIRUSES – ANTIVIRAL AGENTS POOLED Human IgG (IM,IV)- ADOLESCENTS (RICHARDSON et al, Ben Nathan) ANTIVIRALS –VALGANCiCLOVIR et al (HERPES FAMILY), Lerner, Montoya et al RCT in submitted for subset. PLECONARIL - picornaviruses, enteroviruses, rhinoviruses etc ? INTERFERONS (  KERR), AMPLIGEN etc (DER MEIRLEIR) - LIMITED LAURICIDIN OLIVE LEAF EXTRACT OXYMATRINE- CHINESE HERBAL EXTRACT- (CHIA) ANTIRETROVIRALS RALTEGRAVIR/AZT OTHERS ?

30 DOXYCYCLINE, CLARITHROMYCIN, MINOCYCLINE, AZITHROMYCIN, QUINOLONES(CIPROFLOXACIN etc), CHLORAMPHENICOL. Prolonged – 6 weeks- and repeat cycles (2-6) with spacing to check on evidence of infection. OTHER ORGANISMS- CHLAMYDOPHILA, RICKETTSIA, BORRELIA, MYCOPLASMAS ESSENTIAL TO SUPPORT GENERAL HEALTH AND ESPECIALLY TO PROTECT THE GUT- PRO- & PRE-BIOTICS VITAMINS/MINERAL SUPPLEMENTS GUT ENZYMES GLUTAMINE Nicolson CFIDS Chronicle September/October 1999.

31 COMPASSION- THOUGHT – CARE ARE NEEDED EFFECTIVE TREATMENTS ARE AVAILABLE NOW? MORE RESEARCH BIOMEDICAL IS DEFINITELY NEEDED MUCH MORE FUNDING IS NEEDED PATIENTS AND CARERS NEED SUPPORT AND HELP WHY ARE WE DOING NOTHING AND PREVENTING PROVEN TREATMENTS? Thank you


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