ME/CFS & Conflicts of Interest -A NICE Conundrum?

[Guest guest]

A NICE Conundrum?

Margaret

30th December 2008

A NICE conundrum seems to have presented itself,

which the Judge in the Judicial Review of the NICE

Clinical Guideline on " CFS/ME " may require NICE to

explain for the benefit of straight-thinking folk who

cannot readily understand such brain-teasers.

Straight-thinking folk know that NICE is funded by

the UK Department of Health.

These straight-thinking folk also know that the NICE

Guideline on " CFS/ME " (CG53) recommended as the

primary intervention only behaviour modification,

together with incremental aerobic exercise (cognitive

behavioural therapy / CBT and graded exercise

therapy / GET) for a disorder that NICE's own

paymaster accepts is a neurological disease, this

having been confirmed once again in Hansard by the

Parliamentary Under-Secretary of State, Department

of Health, Lord Darzi, on 2nd June 2008.

It seems remarkable indeed that people unfortunate

enough to be stricken with a neurological disease

should not be permitted by NICE to be adequately

investigated, but straight-thinking folk also know

that NICE claims that its recommendations for CBT

and GET in its Guideline are based on the very best

evidence-base, which must surely re-assure these

straight-thinking folk that they will be receiving the

best possible management of their life-destroying

disease.

But here's the conundrum: NICE's own paymaster

(i.e. the Department of Health) is on record as

stating – in writing – that it holds no evidence that

the interventions recommended by NICE in CG53

actually work in restoring the return to work (this

being the underlying purpose of the recommended

management interventions).

This was revealed when the Department of Health

was asked about the recommendations set out in the

NHS Plus National Guideline – which the Department

itself notably funded -- that was published in

October 2006, ( " Occupational Aspects of the

Management of Chronic Fatigue Syndrome: A

National Guideline " in which Wessely School

members Professors Trudie Chalder, White and

Sharpe were instrumental), the

recommendations in that Guideline being the same

recommendations that were adopted by NICE in its

Guideline of August 2007.

Crucially, both Guidelines were based on the same

" evidence-base " : of six Wessely School studies,

three were co-authored by Trudie Chalder and one

was co-authored by White. In the NHS Plus

Guideline, the Wessely School authors made inflated

claims for the efficacy of CBT/GET in returning people

with " CFS/ME " to gainful employment ( " CBT and GET

have been shown to be effective in restoring the

ability to work " ), but a US systematic review of the

" evidence-base " had reported that " No specific

interventions have been proved to be effective in

restoring the ability to work " (SD Ross et al: Arch

Intern Med 2004:164:1098-1107).

The key fact here is that the NHS Plus Guideline

cited the Ross systematic review as its own

evidence-base.

An inquiry was therefore made of the DoH how such

divergent conclusions could be drawn from the same

systematic review of the same publications --- one

conclusion by Ross et al and the exactly opposite

conclusion by the Wessely School. In the light of

such an obvious dichotomy, the DoH was asked a

simple and direct question: " Does the Department

agree with the statement that cognitive behavioural

therapy and graded exercise therapy have been

shown to be effective in restoring the ability to work

in those (with ME/CFS) who are currently absent from

work? "

On 6th June 2008 the written response from the DoH

was unequivocal: " The Department does not hold any

data that support this claim " .

So here we have a situation in which the Department

of Health (which funds NICE and which funded the

NHS Plus Guideline) is on record as stating that it

has no data to support the claims made by both the

NICE Guideline and the NHS Plus Guideline.

If the Department itself holds no data showing that

CBT/GET are in fact effective, where is this data?

Does it actually exist, or is it merely a contrived

" evidence-base " created by the Wessely School,

whose vested interests in claiming its efficacy cannot

be denied?

Regarding the obvious and serious conflicts of

interest of the Wessely School in relation to the NHS

Plus Guideline, on 23rd December 2008 a remarkable

revelation was made – in writing – by Dr Ira Madan,

Director of Clinical Standards, NHS Plus (who, with

Wessely and Chalder, is based at Kings College):

" The Department of Health have (sic) asked me to

investigate your concern that one of the guideline

development group members, Professor Trudie

Chalder, and the two external assessors, Professor

Sharpe and Professor White, had

conflicts of interest whilst involved in the production

of the guideline. I can confirm that I was aware of

the potential for competing interests that you have

stated. The roles that Professor White, Professor

Sharpe and Professor Chalder have undertaken for

the agencies and companies that you stipulate (i.e.

the medical insurance industry) were in the public

domain prior to the publication of the NHS Plus

guideline. I am content, as the Director of that

guideline, these potential competing interests did

not in any way influence the synthesis of the

evidence or the guideline recommendations " .

As straight-thinking folk will recall, the NHS Plus

Guideline states " No conflicts of interest declared " ,

yet Dr Ira Madan is here acknowledging the existence

of these Wessely School conflicts of interests, but

stating that she is " content " about the situation, as

people already knew about them.

In the Wessely School world of NHS Plus, two

researchers were allowed to sit in judgment on their

own publications, with the permission of Dr Ira

Madan. They were not required to make

conflict-of-interest declarations. This is not

peer-review as the rest of the scientific world

understands it.

Notably, the same people (Chalder, Sharpe and

White) who were involved with the production of the

NHS Plus Guideline (where they declared no conflict

of interests) did declare and list very serious

conflicts of interest in the MRC PACE trial

documentation: " PDW has done voluntary and paid

consultancy work for the Departments of Health and

Work and Pensions and legal companies and a

re-insurance company. MCS has done voluntary and

paid consultancy work for government and for legal

and insurance companies. TC has done consultancy

work for insurance companies, is the author of

Coping with Chronic Fatigue published by Sheldon

Press and co-authors Overcoming Chronic Fatigue

with Burgess published by Constable and

. "

(http://www.biomedcentral.com/1471-2377/7/6 ).

This is remarkably different from what the

Department of Health confirmed in relation to the

NHS Plus Guideline – in writing – on 20th November

2008: " I can confirm that the guideline contributors

gave written confirmation that they had no conflicts

of interest " .

What can explain such a marked discrepancy, and

why should a statement have been published saying

that no conflicts of interest exist when serious

conflicts of interests are undoubtedly involved?

Not only do we now have written evidence that (i)

the Department of Health holds no data that the

recommendations in both the NHS Plus Guideline and

in the NICE Guideline are in any way effective in

restoring the ability of people with ME/CFS to return

to work, and (ii) that two members of the DoH

( and Dr Ira Madan) have made

statements on the same issue that diametrically

oppose each other, but we also have written

evidence -- straight from Dr Madan at the

Department of Health -- illustrating how the normal

rules of independent peer review and conflicts of

interest are regularly suspended when it comes to

the " evidence-base " for CBT/GET in people with

ME/CFS.

Consequently, as Dr Madan has stated that the

Wessely School's conflicts of interests did not make

any material difference, she is now being requested

to explain WHY the conflicts of interest she has

acknowledged exist were not recorded as required,

since conflicts of interest should be recorded to

enable people to make up their own mind whether or

not the conflicts matter. Such an important issue is

not up to Dr Madan to decide but is –or should be --

determined by the AGREE Instrument.

Even though it is in the public interest to publicise

that there is a potentially dangerous guideline in

circulation that was engineered by Wessely School

members whose conflicts of interest in respect of the

medical insurance industry are legion (and who have

no expertise in infection or in inflammation or in

immunology that underpin ME/CFS), the Judge will

not be considering the issues surrounding the NHS

Plus Guideline

It is, however, hoped that the Judge will require the

particular conundrum pertaining to NICE to be

explained so that straight-thinking folk can

understand it, namely, why NICE recommended

interventions for " CFS/ME " for which its own

paymaster (the Department of Health) has stated

that there is no supportive data.