The Lancet Letter Prof White -Prof Hooper initial Response

[Guest guest]

The original Word document by Prof. Hooper is

attached for private members - but can also be

found at: http://www.megaupload.com/?d=0UOBR6Q1

(non-members have to wait for about a minute)

A good readable html version can be found at:

http://www.meactionuk.org.uk/Hoopers-initial-response-to-PDW-letter.htm

~jvr

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Initial response by Professor Malcolm

Hooper to an undated letter sent by

Professor White to Dr

Horton, Editor-in-Chief of The Lancet

18th May 2011

On 17th May 2011 Zoe Mullan, Senior Editor at The

Lancet, sent an email to Professor Hooper in

response to the complaint he submitted about the

PACE Trial article published online by The Lancet on

18th February 2011 and subsequently in the journal

on 5th March 2011.

In her email, Zoe Mullan wrote:

“We asked the authors of the PACE trial to

respond to your concerns, which they have

duly done.

Your complaint and their response were

discussed at the highest management level

and this group of executive editors was

fully satisfied that there were no grounds

whatsoever on which to take further

action.

We attach the response provided to us

here. From an editorial perspective, the

case is now closed”.

The undated response to Professor Hooper’s

complaint by Professors White, Sharpe and Chalder

that was sent to Dr Horton (Editor-in-Chief of

The Lancet) on behalf of all the co-authors will, in

the interests of openness and transparency, be

placed in the public domain and will be fully

addressed in due course, as will Professor Hooper’s

concerns over what he believes is the failure of The

Lancet’s editorial process in this instance, but there

is one point in Professor White’s letter that is of

particular importance, so it is addressed in this

initial response.

In their letter, White et al state:

“The PACE trial paper refers to chronic

fatigue syndrome (CFS) which is

operationally defined; it does not purport

to be studying CFS/ME”.

The sentence continues by stating that the PACE

Trial studied:

“CFS defined simply as a principal

complaint of fatigue that is disabling,

having lasted six months, with no

alternative medical explanation (Oxford

criteria)”.

This is exactly what the ME/CFS community

has been saying from the outset, namely

that the PACE Trial was not studying those

with ME.

Soon after the Oxford criteria were published in

1991, one of the co-authors, psychiatrist

, wrote in the British Medical Bulletin:

“British investigators have put forward an

alternative, less strict, operational

definition which is essentially

chronic…fatigue in the absence of

neurological signs, (with) psychiatric

symptoms…as common associated

features”

(AS ; BMB 1991:47:4:966-988).

Given that ME is a classified neurological

disorder (ICD-10 G93.3), there thus ought

to have been no dispute that the PACE Trial

Investigators were not studying those with

ME, but the Investigators have persistently

confirmed that they were studying those

with ME, for example:

1. The PACE Trial Identifier is clear:

“Myalgic encephalomyelitis is thought by

most to be synonymous with CFS”

(PACE Trial Identifier; 2.1).

The cited references for this statement are given as

(i) Fukuda K et al. The chronic fatigue syndrome: a

comprehensive approach to its definition and study.

Ann Intern Med 1994; 121: 953-959;

(ii) Sharpe MC et al. A report – chronic fatigue

syndrome. JR Soc Med 1991; 84: 118-121;

(iii) Wessely SC et al. Chronic fatigue and its

syndromes. Oxford, Oxford University Press, 1998;

(iv) Working group report to the Chief Medical

Officer, www.doh.gov.uk/cmo/cfsmereport 2002 and

(v) NHS Centre for Reviews and Dissemination.

Interventions for the management of CFS/ME.

Effective Health Care 2002; 7(4): 1-12.

2. The two versions of the PACE Trial Protocol (both

the Full Protocol and short version that was

published in BMC Neurology 2007:7:6) are equally

clear; the PACE Trial was:

“A randomised controlled trial of adaptive

pacing, cognitive behaviour therapy, and

graded exercise as supplements to

standardised specialist medical care versus

standardised specialist medical care alone

for patients with the chronic fatigue

syndrome/myalgic encephalomyelitis or

encephalopathy”.

3. In the Glossary to the Full Protocol, Professor

White et al specifically state that CFS/ME is the

official term for the illness described in the

“Working Group Report to the Chief Medical

Officer (2002) and the MRC RAG Report

(2003)”.

4. In the PACE Trial Patient Clinic Leaflet, Professor

White et al state:

“This illness is also known as post-viral

fatigue syndrome, myalgic

encephalomyelitis (ME) and myalgic

encephalopathy (ME).

Medical authorities are not certain that CFS

is exactly the same illness as ME…but we

will be calling this illness CFS/ME”.

In The Lancet article itself, White et al use the

term myalgic encephalomyelitis throughout the text

and actually state:

“Myalgic encephalomyelitis is thought by

some researchers to be the same

disorder….Several diagnostic criteria exist

for chronic fatigue syndrome and myalgic

encephalomyelitis”,

thus implying that they had indeed studied those

with ME.

Moreover, in the authors’ reply published in the

Lancet on 17th May 2011 (The PACE trial in chronic

fatigue syndrome – Authors’ reply), White is

unambiguous:

“…however we defined CFS and myalgic

encephalomyelitis, we found that cognitive

behaviour therapy and graded exercise

therapy provided a significant and clinically

useful advantage….”.

Here, though, Professors White, Sharpe and Chalder

have categorically stated that the PACE Trial

“does not purport to be studying CFS/ME”.

This may explain why so many recruits were not

accepted into the PACE Trial on the stated grounds

they did not fulfil the Oxford criteria for “CFS” (which

according to the Principal Investigators themselves,

is not the same as “CFS/ME”).

If the PACE Trial was not studying CFS/ME

(as now asserted by Professor White et al),

then the results cannot be used by NICE to

support its Clinical Guideline 53 for CFS/ME.

NICE, however, announced on 14th March 2011 that

there will be no review of CG53 until 2013:

“…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”.

Most certainly, this statement by the Principal

Investigators that the PACE Trial did not purport to

be studying those with CFS/ME raises important

issues about the alleged generalisability of the PACE

Trial results, given that The Lancet article

unambiguously states:

“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”.

That The Lancet supports the Principal Investigators’

inconsistent and indefensible position and refuses to

engage with clearly articulated complaints must be

of concern to anyone interested in the integrity of

the scientific process.