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Complaint to The Lancet about the PACE Trial

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Below you will find the first part of a complaint by

Prof. Malcolm Hooper to the editor of The Lancet

about the PACE Trial (White at al) and an article

by Bleijenberg & Knoop; who practice the same

anti-science activities and misleading information

about ME/CFS as their UK partners.

For private members the full text of this complaint

is attached in Word format, but can also be found

at:

http://www.meactionuk.org.uk/COMPLAINT-to-Lancet-re-PACE.doc

http://www.meactionuk.org.uk/COMPLAINT-to-Lancet-re-PACE.htm

~jan van roijen

````

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

(FAST TRACKED)

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 acknowledgment to members of the

ME/CFS community)

March 2011

PREAMBLE

In 1996 when psychiatrists Drs. White and

Simon Wessely co-authored a review of " Chronic

Fatigue Syndrome " (Joint Royal Colleges Report,

CR54, October 1996), a Lancet editorial roundly

condemned the publication ( " Frustrating survey of

chronic fatigue " , Volume 348, Issue 9033, Page 971,

12 October 1996):

" Psychiatry has won the day for now …. The

sixteen-strong committee was top-heavy with

psychiatric experts, so the emphasis on

psychological causes and management is no surprise

…. We believe that the report was haphazardly

set-up, biased, and inconclusive, and is of little help

to patients or their physicians " .

In 2011, when Professors White and Wessely

collaborated in a multi-centre trial of cognitive

behaviour therapy and graded exercise for " CFS " ,

peer review at The Lancet failed to identify the same

faults.

" Psychiatry has won the day " again - but only

because once again the same people have not been

subjected to sufficiently rigorous scientific scrutiny.

INTRODUCTION

This report deals with the results of the PACE Trial

published in The Lancet in the following sections:

1. Terminology and Classification

2. Fast track publication

3. The competing interests of the PACE Trial team

4. The Principal Investigators were not studying

classic ME/CFS

5. Failure to comply with professional ethical

guidance and codes of practice

6. Failure to " control " the PACE Trial

7. Adverse events/reactions and serious deterioration

8. Changes to the entry criteria

9. Consideration of the data on outcomes

10. Data not reported/measures dropped

11. Overview of reporting results

12. Announcement of results to press at the Science

Media Centre

13. Summary/Conclusion.

Having served as an examiner in UK and other

universities at graduate and postgraduate level,

acted as referee for a number of scientific journals

and served on an editorial Board, and having served

on the Committee of the Council for National

Academic Awards and also of the World Health

Organisation, it is my professional opinion, based on

the extensive published biomedical evidence about

myalgic encephalomyelitis/chronic fatigue syndrome

(ME/CFS) and supported by over 2,000 pages of

evidence obtained under the Freedom of Information

Act (FOIA), that the PACE Trial itself was unethical

and unscientific:

the Investigators had already formed their opinion

about the intended outcome; entry criteria were

used that have no credibility; definitions and

outcome measures were changed repeatedly; data

appears to have been manipulated, obfuscated, or

not presented at all (so it cannot be checked), and

the authors' interpretation of their published data as

" moderate " success is unsustainable.

Significant problems with the PACE Trial were

identified from the outset and were brought to the

attention of the Medical Research Council (a

co-funder), who for over eleven months failed to

respond.

The concerns thus became the subject of at least

two separate formal complaints at Ministerial level.

A formal complaint about the West Midlands

Multicentre Research Ethics Committee (MREC) that

approved the PACE Trial Protocol was also served on

the National Research Ethics Service (NRES) at the

National Patient Safety Agency.

The Lancet has published a report of a study about

which legitimate and serious concerns were raised

that are centred on apparent coercion and

exploitation of patients; on the contempt in which

patients are seen to be held; on manipulation; on

pretension and misrepresentation; on reliance on

flawed studies yielding meaningless results; on the

remarkable lack of scientific rigour throughout the

trial; on the unusual personal financial interest of

the Chief Principal Investigator (whose own money

funded the PACE Trial entry criteria); on the vested

interests of all the Principal Investigators, of the

Director of the PACE Clinical Trial Unit and of the

centre statistician; on the intentional inclusion of

patients who do not suffer from the disorder

supposedly being studied; on the lack of individual

equipoise, and the failure to adhere to CONSORT

(Consolidated Standards of Reporting Trials), to the

Department of Health Research Governance

Framework for Health and Social Care, Second

Edition, 2005; 2:3:1; to the General Medical Council

" Good Practice in Research " and " Consent to

Research " , and to the Declaration of Helsinki (which

is clear:

" Authors, editors and publishers all have ethical

obligations with regard to the publication of the

results of research….Reports of research not in

accordance with the principles of this Declaration

should not be accepted for publication " ).

On the basis of evidence seen, the underlying

non-clinical purpose of the trial had the primary aim

of removing patients from benefits (ie. the use of

motivational behaviour therapy to achieve the

intended result of the cessation of State/insurance

benefits for patients with ME/CFS), as those involved

with the trial continue to maintain that for people

with ME/CFS, " medical intervention is no longer

appropriate " and that the aim of therapy is to

" reduce healthcare usage "

(http://www.meactionuk.org.uk/Problems_and_Solutions.htm).

In one of the MRC secret files about ME/CFS held at

the National Archives in Kew (files that are closed for

an unusually lengthy period of 73 years instead of

the customary 30 years, some of which have been

legally obtained), one of the Principal Investigators

(PIs) of the PACE Trial (Professor Sharpe),

admitted that CBT and GET were:

" a purely pragmatic approach and without theoretical

foundation "

(CIBA Foundation Symposium, 12th-14th May 1992,

reference S 1528/1).

Particularly notable is that the same document

states about ME/CFS patients:

" The first duty of the doctor is to…avoid the

legitimisation of symptoms and reinforcement of

disability " .

Avoiding the legitimisation of the symptoms

of ME/CFS was considered by many to be the

purpose of the PACE Trial.

The Manuals used in the PACE Trial show that the

authors either ignored medical science or that they

do not understand medical science.

The Manuals describe behaviours and techniques that

should not -- and I believe cannot -- be considered

ethical by any independent and reasonable observer,

particularly the intense pressure on both therapists

and participants to obtain the " right " results for the

PIs and their funders (pressures that are supported

by participants' published comments).

Much of the written information and instruction to

therapists and doctors is contradictory and internally

inconsistent and appears highly exploitative, as well

as revealing an ignorance of ME/CFS.

One of the substantive complaints to the Minister

about the PACE Trial can be accessed at

http://www.meactionuk.org.uk/magical-medicine.htm

and it addresses in detail the numerous ethical and

scientific failures of the study.

As Chief Principal Investigator, Professor White

was aware of these complaints and in the interests

of transparency and under the requirement for

disclosure had a duty to bring them to the attention

of The Lancet editorial staff before publication of the

PACE Trial results, which he failed to do.

For The Lancet to have published an article reporting

a study that completely ignored the existing

biomedical evidence-base of over 4,000 published

papers about the disorder allegedly studied,

including documented physiological contra-

indications regarding aerobic exercise, is a matter of

concern to the international scientific community, as

it is in defiance of basic principles of scientific

research.

It also contravenes the Elsevier Editorial System

(Ethics in Publishing: Instructions to Authors) which,

under " Ethics and Procedures (General) " , sets out its

" fundamental principles " that " the paper should….be

appropriately placed in the context of prior and

existing research " .

Indeed, the UK Department of Health, a co-funder of

the PACE Trial, stipulates that:

" All existing sources of evidence…must be considered

carefully before undertaking research "

(Research Governance Framework for Health and

Social Care, Second Edition, 2005; 2:3:1).

Not only did White et al ignore the international

biomedical evidence-base pertaining to ME/CFS,

whilst in their article they make reference to the

FINE Trial (Fatigue Intervention by Nurses

Evaluation, a sibling of the PACE Trial), they do not

point out that it failed (BMJ 2010:340:c1777), and

they also failed to take due cognisance of the mixed

evidence-base about the efficacy of CBT/GET which

shows that those interventions are not effective in

general and specifically that they may be harmful for

people with ME/CFS.

Feedback from almost 5,000 ME/CFS patients via

several charities indicates that deterioration

following exercise is reported in almost 50% of cases

and indeed, in 2002 the Chief Medical Officer's

Working Group Report highlighted the disparity

between feedback from patients and the reported

findings of the Wessely School (see below), stating:

" …the data clearly indicate that the York review

results (of controlled trials) do not reflect the full

spectrum of patients' experience " .

Nine years later, the £5 million PACE Trial (at a cost

of £7,500 per participant) takes us no further

forward, as safe guidance on management options

must address the needs of all patients with ME/CFS.

The PACE Trial excluded those more severely

affected by ME/CFS (since including such patients

would have greatly reduced any apparent benefit of

the interventions), so it is not the case that the

PACE Trial results are generalisable to all people

with the disorder as claimed by the authors.

It is essential that the findings of the PACE Trial are

properly identified, interpreted and presented. The

most pressing concern is that the findings published

in The Lancet will be deemed appropriate for all

people with ME/CFS, many of whom stand to suffer

iatrogenic harm from incremental aerobic exercise

because the findings of research conducted on the

Oxford criteria (as used in the PACE Trial) cannot

justifiably be applied to people with classic ME as

recommended in The Lancet article, even with the

authors' caveat " only if fatigue is their main

symptom " .

Thus a major factor motivating this complaint is

that, as a result of The Lancet article, it is highly

likely, perhaps even inevitable, that patients with

classic ME/CFS will be forced to undertake exercise

regimes as " rehabilitation " on pain of losing their

State benefits, which are often their sole means of

financial survival.

Such regimes are guaranteed to exacerbate the

symptoms of an already very difficult-to-bear illness.

In such a situation, resort to suicide is not

unimaginable and indeed already occurs

with higher than normal regularity.

The President of the International Association for

ME/CFS, Professor Fred Friedberg from Stony Brook

University, New York, emphasised his concern about

the take-home message from the press conference

held at the Science Media Centre (where Professor

Wessely, Director of the PACE Clinical Trial Unit, is

on the Science Advisory Panel) which rapidly led to

the spread of false information around the world,

that message being:

" Exercise is good; Rest is bad " , because the

evidence is that exercise regimes are " potentially

harmful for patients with CFS/ME " .

In his own press release, Professor Friedberg

commented about the PACE Trial article in The

Lancet:

" The most fundamental concern we have is focused

on the type of causal model that was linked to the

CBT and GET conditions in this study.

The model, based on the application of cognitive

behavioural and physical deconditioning principles,

predicts that properly designed behavioural or

exercise interventions will 'reverse' the CFS illness.

Not improve symptoms/functioning or provide better

management, but 'reverse' the illness. This term

implies that the illness can be cured (or something

close to it) with behavioural techniques….If one

assumes such a direct correspondence between

behavioural treatment and curative outcomes, then

the illness is by implication a psychiatric

condition….Perhaps this is the most unfortunate

aspect of the PACE trial: the omission of any

reference to the medical complexity of this illness "

http://www.iacfsme.org/PACETrial/tabid/450/Default.aspx

In his closing remarks to an annual conference of

about 300 civil servants on 3rd February 2011 held in

London, the Government's Chief Scientific Advisor

(Professor Sir Beddington CMG, FRS) said that

pseudo-science ought to be considered in the same

way as racism:

" We are grossly intolerant, and properly so, of

racism….We are not…grossly intolerant of

pseudo-science, the building up of what purports to

be science by the cherry-picking of the facts and the

failure to use scientific evidence and the scientific

method " (http://bit.ly/eUNIrB).

To have published the contrived results of

what can only be described as pseudo-

science is not only damaging to patients

but also to The Lancet, as well as raising

legal implications for clinicians who may

rely on the published conclusions of the

study and who might thereby be in

breach of GMC regulations and of advice

from the medical defence unions.

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