slysaint
Senior Member
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probably on a thread somewhere:
https://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=3&ved=0ahUKEwjvj9G7y9PUAhUJblAKHSHuD78QFgg2MAI&url=http://www.25megroup.org/Information/Medical/Margaret%20Williams/PROOF%20POSITIVE.doc&usg=AFQjCNEOdZfGooQDYdWqcAexEstf0YtTmA&cad=rja
PROOF POSITIVE ? (REVISITED)
Margaret Williams 14th September 2016
"
Another follow-up study of PACE participants is scientifically meaningless because there is no way of
taking into account the effect of other interventions which the participants may have used after the
PACE trial ended in 2009.
The GETSET trial (Graded Exercise Therapy guided SElf-help Treatment) for patients with chronic
fatigue syndrome/myalgic encephalomyelitis was described as a randomised controlled trial in
secondary care:
“This study will test the acceptability, effectiveness, cost effectiveness and safety of
Graded Exercise Therapy guided SElf-help Treatment (GETSET) for patients with CFS/ME attending
hospital clinics. GETSET has been designed to incorporate the best elements of GET provided by
current and previous research trials, paying particular attention to safety and acceptability”.
The methodology involved participants being given a booklet and interviewed by telephone or skype. Peter
White was the Chief Principal Investigator of GETSET; originally, it ran from 1st December 2011 to
30th November 2014 (ie. before he had been forced to release the PACE trial data) and funding was
£244,056.00 but Peter White changed the primary outcome measures and asked for the trial to be
extended until December 2015."
"
One question which needs to be addressed is whether his obsession with advancing his own ideology
may have caused him to place PACE participants at serious risk: PACE had no serial checks on
participants’ immune parameters even though in 2004 Peter White himself published a paper on this
important aspect (Immunological changes after both exercise and activity in chronic fatigue syndrome:
a pilot study. White PD, KE Nye, AJ Pinching et al. JCFS 2004:12 (2):51-66).
In that article, White et al stated:
“We designed this pilot study to explore whether the illness was associated with alterations in
immunological markers following exercise. Immunological abnormalities are commonly observed in
CFS…Concentrations of plasma transforming growth factor-beta (TGF-) (anti-inflammatory) and
tumour necrosis factor-alpha (TNF-) (pro-inflammatory) have both been shown to be
raised….Abnormal regulation of cytokines may both reflect and cause altered function across a broad
range of cell types…..Altered cytokine levels, whatever their origin, could modify muscle and or
neuronal function.
“Concentrations of TGF-1 were significantly elevated in CFS patients at all times before and after
exercise testing.
“We found that exercise induced a sustained elevation in the concentration of TNF-which was still
present three days later, and this only occurred in the CFS patients.
“TGF-was grossly elevated when compared to controls before exercise (and) showed an increase in
response to the exercise entailed in getting to the study centre.
“These data replicate three out of four previous studies finding elevated TGF-in subjects with CFS.
“The pro-inflammatory cytokine TNF-is known to be a cause of acute sickness behaviour,
characterised by reduced activity related to ‘weakness, malaise, listlessness and inability to
concentrate’, symptoms also notable in CFS.
“These preliminary data suggest that ‘ordinary’ activity (ie. that involved in getting up and travelling
some distance) may induce anti-inflammatory cytokine release (TGF), whereas more intense exercise
may induce pro-inflammatory cytokine release (TNF-) in patients with CFS”.
This important information was withheld from participants and therapists alike (the Therapists’
Manual on GET was dismissive of studies showing immune dysfunction in ME/CFS).
In the light of this knowledge, it is notable that there seems to have been a cavalier disregard of safety
for GET participants, even though Peter White was aware that three days after exercise, TNFremains
elevated and that this probably accounts for the “sickness behaviour” and “weakness, malaise,
listlessness and inability to concentrate”.
https://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=3&ved=0ahUKEwjvj9G7y9PUAhUJblAKHSHuD78QFgg2MAI&url=http://www.25megroup.org/Information/Medical/Margaret%20Williams/PROOF%20POSITIVE.doc&usg=AFQjCNEOdZfGooQDYdWqcAexEstf0YtTmA&cad=rja
PROOF POSITIVE ? (REVISITED)
Margaret Williams 14th September 2016
"
Another follow-up study of PACE participants is scientifically meaningless because there is no way of
taking into account the effect of other interventions which the participants may have used after the
PACE trial ended in 2009.
The GETSET trial (Graded Exercise Therapy guided SElf-help Treatment) for patients with chronic
fatigue syndrome/myalgic encephalomyelitis was described as a randomised controlled trial in
secondary care:
“This study will test the acceptability, effectiveness, cost effectiveness and safety of
Graded Exercise Therapy guided SElf-help Treatment (GETSET) for patients with CFS/ME attending
hospital clinics. GETSET has been designed to incorporate the best elements of GET provided by
current and previous research trials, paying particular attention to safety and acceptability”.
The methodology involved participants being given a booklet and interviewed by telephone or skype. Peter
White was the Chief Principal Investigator of GETSET; originally, it ran from 1st December 2011 to
30th November 2014 (ie. before he had been forced to release the PACE trial data) and funding was
£244,056.00 but Peter White changed the primary outcome measures and asked for the trial to be
extended until December 2015."
"
One question which needs to be addressed is whether his obsession with advancing his own ideology
may have caused him to place PACE participants at serious risk: PACE had no serial checks on
participants’ immune parameters even though in 2004 Peter White himself published a paper on this
important aspect (Immunological changes after both exercise and activity in chronic fatigue syndrome:
a pilot study. White PD, KE Nye, AJ Pinching et al. JCFS 2004:12 (2):51-66).
In that article, White et al stated:
“We designed this pilot study to explore whether the illness was associated with alterations in
immunological markers following exercise. Immunological abnormalities are commonly observed in
CFS…Concentrations of plasma transforming growth factor-beta (TGF-) (anti-inflammatory) and
tumour necrosis factor-alpha (TNF-) (pro-inflammatory) have both been shown to be
raised….Abnormal regulation of cytokines may both reflect and cause altered function across a broad
range of cell types…..Altered cytokine levels, whatever their origin, could modify muscle and or
neuronal function.
“Concentrations of TGF-1 were significantly elevated in CFS patients at all times before and after
exercise testing.
“We found that exercise induced a sustained elevation in the concentration of TNF-which was still
present three days later, and this only occurred in the CFS patients.
“TGF-was grossly elevated when compared to controls before exercise (and) showed an increase in
response to the exercise entailed in getting to the study centre.
“These data replicate three out of four previous studies finding elevated TGF-in subjects with CFS.
“The pro-inflammatory cytokine TNF-is known to be a cause of acute sickness behaviour,
characterised by reduced activity related to ‘weakness, malaise, listlessness and inability to
concentrate’, symptoms also notable in CFS.
“These preliminary data suggest that ‘ordinary’ activity (ie. that involved in getting up and travelling
some distance) may induce anti-inflammatory cytokine release (TGF), whereas more intense exercise
may induce pro-inflammatory cytokine release (TNF-) in patients with CFS”.
This important information was withheld from participants and therapists alike (the Therapists’
Manual on GET was dismissive of studies showing immune dysfunction in ME/CFS).
In the light of this knowledge, it is notable that there seems to have been a cavalier disregard of safety
for GET participants, even though Peter White was aware that three days after exercise, TNFremains
elevated and that this probably accounts for the “sickness behaviour” and “weakness, malaise,
listlessness and inability to concentrate”.