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 Slide 2 A TRAVESTY OF SCIENCE Slide 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 Slide 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 Slide 5 PACE SF-36 SCORE ENTRY 60,65, 70 60 (11) 65* 70
SF-36 SCORES OUTCOMES NORMAL RANGE +/- 1 SD 60 65 707585 8090 - 5%
A. W.A.ALL A.A. Slide 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.] Slide 7 REVISED OUTCOMES - INTERCONVERSION CHALDER
LIKERT 4 8 19 5 10 -21 6 12 23 9 18 -29 18 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 Slide 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.
Slide 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 Slide 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. Slide 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 PDWS OWN WORK ON TNF-ALPHA. THIS ALSO INDICATED THE
DELAYED EFFECTS OF POST-EXERTIONAL MALAISE. White et al JCFS
2004;12:57-66. Slide 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. Slide 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). Slide 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. Slide 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 BODYS 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 Slide 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 Slide 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 factorswhich 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 Slide 18 IT
DOES NOT DO WHAT IT SAYS ON THE TIN TANTAMOUNT TO FRAUD Slide 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! Slide 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 Slide 21
SOMATISATION PAR EXCELLENCE [Hysteria] CAUSATION FORGET IT!!!! CFS
PATHWAY PANEL- courtesy of Dr Spurr Slide 22 WHAT DO YOU THINK OF
PACE TRIAL,NHS TREATMENT AND NICE GUIDELINES? RUBBISH!! Courtesy of
Dr Irving Spurr, 2011 Slide 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 Slide 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! Slide 25 Hypothesis ABCDEFGHIJKABCDEFGHIJK Final
common pathway(s ) CFS/ME Insults Initial processes Courtesy of
Jonathan Kerr JID 2008 Slide 26 PROTEOMICS Separation of proteins
in CSF in Neurologic post treatment Lyme Disease and ME-CSF
patients Schutzer et al 2011 Slide 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. Grandmas Organic Cooking
CHOLINE/VITC Slide 28 WHICH OF THESE TWO CAN HAVE A ROUTINE TEST
FOR VP1 ENTEROVIRUS MARKER Slide 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 ? Slide 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. Slide 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
