Wednesday, May 18, 2011

PACE and The Lancet

To whom it may concern,

The recently published results of the UK PACE Trial on 'CFS/ME' in The
Lancet[1] have received widespread professional and patient condemnation
of a high volume and nature rarely directed at a (so-called)
peer-reviewed scientific paper. Such condemnation follows upon similar
widespread concerns repeatedly voiced from the trial's questionable
inception.

The scientific criticisms centre around the highly controversial patient
selection criteria, the deeply flawed methodology used and the untenable
conclusions extrapolated by the study's authors on 'pacing', cognitive
therapies and graded exercise: particularly when applied to World Health
Organisation defined Myalgic Encephalomyelitis patients[2][3].

In my view and that of many others, supportive comment on PACE presented
by the UK Science Media Centre and The Lancet has been overwhelmingly
unbalanced and unrepresentative and has therefore rightly been the
subject of much criticism[4]. Much of the pro-PACE comment has also
attempted to misleadingly portray CBT/GET treatment for 'CFS/ME'
patients as comparative to adjunctive secondary use of such therapies
for other physically ill patients. The true nature of CBT/GET as applied
to 'CFS/ME' patients in PACE is however quite different as, unlike
standard CBT, without undertaking appropriate physical examination it
controversially assumes patients exaggerate their primary illness and
that muscles are simply de-conditioned. This questionable form of
combined CBT/GET is then applied as a substitute for biomedical
treatment of primary illness: all done in the face of a large body of
contra-indicating scientific evidence
[5].

The third broad area of condemnation of the PACE Trial is concerned with
bias, conflicts of interest and the alleged misuse of millions of pounds
of UK taxpayer's money. PACE trial architects and principal
investigators have demonstrable connections with the transnational
permanent health insurance industry that stands to gain substantial sums
of money if ME is misrepresented and mistreated as little more than a
somatoform disorder. The same can be said, in the medium term at least,
for the Department of Work and Pensions (DWP) - which is one of the
major UK public agencies funding PACE along with the Department of
Health and the Medical Research Council.

Whilst limiting biomedical support, treatment and research may
ultimately be a financial win win situation for permanent health
insurers, the same cannot be said of the UK state. If questionable or
exaggerated claims for psychosocial treatments, as alleged in the
state-funded PACE trial, lead to mistreatment and inadequate welfare
support for ME patients, as evidence shows that they undoubtedly
will[6], then patients' health will worsen in the long-run and amount to
an even greater burden upon NHS and welfare provision per patient.
Thus,
for example, with PACE in mind, the 2006 report of the Parliamentarians'
Inquiry 'Group on the Scientific Research into ME (GSRME)' issued a
stern warning:

"There have been numerous cases where advisors to the DWP have also had
consultancy roles in medical insurance companies. Particularly the
Company UNUM Provident. Given the vested interest private medical
insurance companies have in ensuring CFS/ME remain classified as a
psychosocial illness there is blatant conflict of interest here. The
Group find this to be an area for serious concern and recommends a full
investigation of this possibility by the appropriate standards body. It
may even be that assessment by a medical expert in a field of high
controversy requires a different methodology of benefit assessment."[7]

Under such circumstances it is alarming to note that The Lancet has
chosen to publish less than one quarter of the correspondence it has
received that is critical of PACE[8][9]. Moreover, they chose to
unfairly limit it in length so as to make it extremely difficult to
adequately set out complex evidence. The Lancet's on-line article in
response to complaints about the PACE Trial entitled 'Patients' power
and PACE'[10] is, in my opinion, little more than an exercise in
pro-PACE spin. It states: "Once every few years, we publish a paper that
elicits an outpouring of consternation and condemnation from individuals
or groups outside our usual reach. The latest topic to have caused such
a reaction is chronic fatigue syndrome (CFS), and — more specifically —
Peter White and colleagues' randomised PACE trial published on March 5,
this year." The Lancet then makes the following assertion:

"But one cannot help but wonder whether the sheer anger and coordination
of the response to this trial has been born not only from the
frustration many feel about a disabling condition, but also from an
active campaign to discredit the research." [10]

This is a highly misleading, assertion that is not worthy of a
prestigious peer-reviewed journal and should be withdrawn. From the
outset, The Lancet appears to give the impression that it is only
patients who have complained when the truth is that PACE has received
widespread international condemnation from leading ME specialists and
other medical and science professionals.
Indeed, a formal, erudite and
comprehensive complaint was made to The Lancet about PACE and related
issues by Professor Malcolm Hooper that The Lancet editor, Richard
Horton, and his staff have spectacularly failed to satisfactorily
answer[11]. Moreover, to dismiss the concerned efforts of exhausted,
poorly resourced and struggling patients as a coordinated "active
campaign to discredit the research"[10] in the medico-political context
of the state and insurance-industry backed PACE trial[12] is not only
disgraceful, it is the intellectual equivalent of pretending that a
minnow is guilty of assailing a great White shark.

Adding more aspersion to apparent ignorance, The Lancet then goes on to
assert: "White and colleagues have been accused of having 'formed their
opinion about the intended outcome' before the [PACE] trial began. This
view is unjustified and unfair... The evidence might even suggest that
it is the critics of the PACE trial who have formed their opinions
first, ignoring the findings of this rigorously conducted work." [10]

It is my opinion that the authors of this Lancet response article have
not only failed to address erudite criticisms of PACE put to them[11],
but demonstrate little evidence of having actually read them. In my
view, in disregard of "rigorously conducted" PACE-critique, it is the
editor and staff of The Lancet "who have formed their opinions
first"[10]. Such behaviour makes The Lancet little more than a de-facto
platform for establishment policy-led junk-science[13] that has
abandoned the best-interests of vulnerable patients and the high
standards of genuine scientific peer-review. Richard Horton and his
colleagues should be ashamed.

Anglia ME Action.
May 2011.
contact@angliameaction.org.uk

'PACE and the end of The Lancet's claim to impartiality' is available
online as a pdf at:
www.angliameaction.org.uk/docs/PACE-Lancet-Impartiality.pdf

ENDNOTES:

[1] Comparison of adaptive pacing therapy, cognitive behaviour therapy,
graded exercise therapy, and specialist medical care for chronic fatigue
syndrome (PACE): a randomised trial; PD White et al; published online,
The Lancet, February 18, 2011 DOI:10.1016/S0140-6736(11)60096-2.

[2] 'Myalgic Encephalomyelitis / Post Viral Fatigue Syndrome (ME/PVFS)'
is categorised by the WHO as a physical neurological disorder in section
G93.3 of the tenth revision of the International Classification of
Diseases (ICD-10-G93.3). Idiopathic 'Fatigue Syndrome (FS)' is
categorised by the WHO as a psychiatric disorder in ICD-10-F48.0. The
WHO have made it abundantly clear that the two illnesses are entirely
separate and not to be conflated yet, from the outset, The PACE Trial
and its architects have apparently disregarded such taxonomical rigour.

[3] Such concerns have been eruditely set out in: 'REPORT: COMPLAINT TO
THE RELEVANT EXECUTIVE EDITOR OF THE LANCET ABOUT THE PACE TRIAL
ARTICLES PUBLISHED BY THE LANCET. Comparison of adaptive pacing therapy,
cognitive behaviour therapy, graded exercise therapy, and specialist
medical care for chronic fatigue syndrome (PACE): a randomised trial. PD
White et al, published online February 18, 2011.
DOI:10.1016/S0140-6736(11)60096-2, and Chronic fatigue Syndrome: where
to PACE from here? G Bleijenberg and H Knoop, published online February
18, 2011 DOI:10.1016/S0140-6736(11)60172-4' Submitted by Malcolm Hooper,
Emeritus Professor of Medicinal Chemistry (with grateful acknowledgement
to members of the ME/CFS community), March 2011. At:
  http://www.meactionuk.org.uk/COMPLAINT-to-Lancet-re-PACE.htm

[4] See for example: 'The Media and ME', Margaret Williams, 16th April
2011. At:
http://www.meactionuk.org.uk/The-Media-and-ME.htm
And See: 'REPORT: COMPLAINT TO THE RELEVANT EXECUTIVE EDITOR OF THE
LANCET ABOUT THE PACE TRIAL ARTICLES PUBLISHED BY THE LANCET. Comparison
of adaptive pacing therapy, cognitive behaviour therapy, graded exercise
therapy, and specialist medical care for chronic fatigue syndrome
(PACE): a randomised trial. PD White et al, published online February
18, 2011. DOI:10.1016/S0140-6736(11)60096-2, and Chronic fatigue
Syndrome: where to PACE from here? G Bleijenberg and H Knoop, published
online February 18, 2011 DOI:10.1016/S0140-6736(11)60172-4' Submitted by
Malcolm Hooper, Emeritus Professor of Medicinal Chemistry (with grateful
acknowledgement to members of the ME/CFS community), March 2011. At:
http://www.meactionuk.org.uk/COMPLAINT-to-Lancet-re-PACE.htm

[5] As Professor Komaroff rightly stated back in 2006: "...there are now
over 4,000 published studies that show underlying biomedical
abnormalities in patients with this illness. It's not an illness that
people can simply imagine that they have and it's not a psychological
illness. In my view, that debate, which has waged for 20 years, should
now be over." Professor Anthony Komaroff, Harvard Medical School:
Speaking at the USA Government CDC (Centers for Disease Control and
Prevention) press conference on 3 November 2006:
  http://www.cdc.gov/media/transcripts/t061103.htm

[6] See for example: 'The involvement of the PACE Trial Principal
Investigators and the Director of the Clinical Trials Unit with the
Department for Work and Pensions', Margaret Williams, 31st March 2011. At:
http://www.meactionuk.org.uk/PACE-PIs-and-the-DWP.htm

[7] See page 30 of the 2006 report of the Parliamentarians' Inquiry
'Group on the Scientific Research into ME (GSRME)' at:
www.erythos.com/gibsoninquiry/index.html

[8] The article entitled 'PACE is dead, long live PACE?' sent by Anglia
ME Action to The Lancet on 28 April 2011 was not even acknowledged let
alone published by them. This document is available online at the AMEA
website:
www.angliameaction.org.uk/docs/PACE-Zombie-Science.pdf

[9] Necessarily brief letters critical of PACE published on The Lancet
website are at:
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60689-2
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60683-1
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60688-0
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60681-8
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60685-5
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60684-3
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60686-7
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2811%2960682-X/fulltext


[10] Patients' power and PACE, The Lancet, Early Online Publication, 17
May 2011 doi:10.1016/S0140-6736(11)60696-X
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2811%2960696-X/fulltext


[11] See: 'REPORT: COMPLAINT TO THE RELEVANT EXECUTIVE EDITOR OF THE
LANCET ABOUT THE PACE TRIAL ARTICLES PUBLISHED BY THE LANCET. Comparison
of adaptive pacing therapy, cognitive behaviour therapy, graded exercise
therapy, and specialist medical care for chronic fatigue syndrome
(PACE): a randomised trial. PD White et al, published online February
18, 2011. DOI:10.1016/S0140-6736(11)60096-2, and Chronic fatigue
Syndrome: where to PACE from here? G Bleijenberg and H Knoop, published
online February 18, 2011 DOI:10.1016/S0140-6736(11)60172-4' Submitted by
Malcolm Hooper, Emeritus Professor of Medicinal Chemistry (with grateful
acknowledgement to members of the ME/CFS community), March 2011. At:
http://www.meactionuk.org.uk/COMPLAINT-to-Lancet-re-PACE.htm

[12] See for example: CORPORATE COLLUSION? Professor Malcolm Hooper,
Eileen Marshall, Margaret Williams. September 2007. At:
http://www.meactionuk.org.uk/Corporate_Collusion_2.htm

[13] See for example: Professor Bruce Charlton – Zombie Science – a
sinister consequence of evaluating scientific theories purely on the
basis of enlightened self-interest, Medical Hypotheses (2008) 71
327-329, DOI: 10.1016/j.mehy.2008.05.018:
http://medicalhypotheses.blogspot.com/2008/07/zombie-science-dead-but-wont-lie-down.html

And see: 'PACE is dead, long live PACE?' Anglia ME Action, 28 April
2011. At:
www.angliameaction.org.uk/docs/PACE-Zombie-Science.pdf

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