NICE Rechtzaak 2009

Ian Gibson was voorzitter van de buitenparlementaire onderzoeksgroep

die de in 2005/2007 de gang van zaken rond ME/CVS in Engeland heeft onderzocht.

Voor berichtgeving over het onderzoek en onderzoeksrapport: klik hier en hier.

Als men de feiten en argumenten in onderstaande getuigenis objektief beschouwt,

is het oordeel in de NICE-rechtszaak (klik hier) logisch gezien volstrekt onbegrijpelijk.

Of zouden andere argumenten een rol spelen bij de totstandkoming van het vonnis?

DR IAN GIBSON’S WITNESS STATEMENT

IN SUPPORT OF FRASER & SHORT v NICE:

Mr Jamie Beagent Leigh Day & Co Solicitors

Priory House

25 St John"s Lane

London EC1M 4LB

Our Ref: SHOR01001/01081040/jb

21 July 2008

Dear Mr Beagent

Re: Douglas Fraser & Kevin Short v NICE Case Number: CO/10408/2007

I have been Member of Parliament for Norwich North since 1997

and have a background and interest in science and health issues:

I taught in the School of Biology at the University of East Anglia from 1965,

was Dean from 1991 to 1997 and was made Honorary Professor in 2003;

I served on the House of Commons Science & Technology Select Committee

and was its chairman from 2001 to 2005.

In 2005 I established and chaired a cross-party ME/CFS science inquiry

with members from both Houses of Parliament,

The Group on the Scientific Research into ME (GSRME),

that reported in November 2006;

The GSRME was a NICE Stakeholder;

I am currently Secretary to the All Party Parliamentary Group on ME.

I am writing to support Kevin Short and Douglas Fraser in the Judicial Review of

the National Institute for Health and Clinical Excellence (NICE) Guidelines for ME/CFS.

I am unhappy with the current NICE Guidelines on ME/CFS.

I am also concerned that

the composition of the Guideline Development Group (GDG)

was unbalanced and unrepresentative and

consequently excluded biomedical expertise.

The current guidelines recommend

cognitive behavioural therapy (CBT) and raded exercise therapy (GET)

as the "clinically excellent" first choice treatment for most patients;

however the guidelines understate the potential harm with graded exercise.

The study by A Peckerman, J Lamanca et al, for example,

found that in severe cases ME/CFS patients may also develop reduced circulation

which may lead to heart conditions:

so graded exercise may be potentially fatal for them.

There is a considerable body of

international peer-reviewed evidence and expert opinion

giving some indication that graded exercise therapies

may also cause harm to patients other

than just the most severely affected.

This suggests further biomedical research on such matters is urgently required.

That the GDG did not adequately consider

the large body of existing international evidence

means they were in no position to make the recommendations they did

on the use, efficacy and safety of such therapies.

NICE claims that

both CBT and graded exercise therapy are supported by an adequate evidence base,

however,

the GDG relied on

a very small number of controversial randomised control trials (RCTs).

The patient selection criteria for participating in the trials

were too wide and therefore allowed non-ME/CFS suffers to participate.

It is also misleading to refer to CBT & GET as "treatments" of "choice".

They cannot properly be described as treatments,

since, as NICE admits, they do not address the core pathology of ME.

Neither is there effective choice given

that many patients will be denied much of the knowledge

they need to make informed decisions

and there is little alternative to CBT GET on offer in the NHS.

CBT/GET have also been rejected by ME patient charities in the UK.

The NICE Guidelines give the false impression,

to doctors, politicians, and the MRC,

that effective treatments are available for ME patients.

NICE would do better to honestly admit that

their core therapy recommendations are not properly evidence-based,

and to use this admission

as the starting point for an adequately-funded search for a cure.

We should not forget that ME patients have a legitimate right to aspire to a cure.

Far too many doctors appear to have lost sight of that objective.

That NICE did not adequately take into account

the general international biomedical evidence base was highlighted

by the GSRME committee of senior parliamentarians I chaired in 2005-6

who were concerned with

both the psychiatric dominance in the current UK ME research programmes

and patient selection criteria they use.

I am therefore disappointed that the NICE GDG did not adopt or endorse

high quality internationally recognised patient selection

and diagnostic criteria such as the Canadian Criteria

even though the latter were mentioned in the Guideline.

I am also concerned that the NICE GDG did not properly fulfil its remit

and did not properly adhere to

the internationally accepted high standards of guideline development

such as the European Union AGREE instrument of which NICE is a signatory.

The NICE GDG also failed to endorse

the World Health Organisation definition of ME/CFS as a neurological disorder

despite the fact the Department of Health and Government Ministers

have repeatedly confirmed that they do agree with this classification.

I do not believe that the NICE CFS/ME Guidelines are fit for purpose.

Yours sincerely

Dr Ian Gibson MP

for Norwich North

Secretary to the All Party Parliamentary Group on ME

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