United Kingdom: 2007 NICE CFS/ME GUIDELINE

How to limit the evidence even further.

Accuse authors of bias to try and discredit papers on thing you don't want included. Obviously that does include CBT and GET

"3/6 of good studies failed to distinguish CFS/ME from others. 3 were head up tilt test, but all were from authors who developed the head up tilt test (bias)"

Or just drop it as soon as you can

" Gamma -globulin – no age definition or case definition. The GDG agreed to drop this"

Or say that it was harmful

"One trial of immunoglobulins in children showed beneficial effects, however this intervention may also be harmful"

or worried about that one trial that was promising but never got funded again

"The GDG was reminded that it had agreed not to make an evidence statement on the basis of one trial."

 

Limit access to published papers so members of the GDG don't get to read them. Limit requests by members of the GDG for more information due to "lack of time".

"Graded Exercise XX Can we access more details about the definition of Graded exercise? XX We can try to get as much info that is in the published papers as we have limited time to contact authors XX We discussed this at lunch and XX has volunteered to contact authors and collate definitions in order to improve this work. XX Can you forward us have copies of papers? XX/XX No this would breach copyright laws, this is why we present a narrative summary."

 

Make sure participants are uncomfortable and cannot hear proceedings

"Venue XX venue comments? Sound? Other room? Microphones? XX we can look into lapel mic’s for some people."

 

Dilute down any evidence you don't like into meaningless and misleading statements

"It was agreed that it should be combined into one evidence statement as follows: “ Surveys of patients {largely but not exclusively from patient groups} carers, HCPs and others report mixed findings regarding the adequacy of support for CFS/ME”

and

"A member said that the guideline must acknowledge that some people will be made worse following a GET programme. Another member said that if the guideline gives a message that it has significant risk, patients won’t be offered GET. In addition, there are already a number of caveats in the guideline. It was agreed that something should be included in the guideline that says that the GET is not appropriate for someone who does not want to partake in GET (after appropriate explanation)."

 

Thanks for all these notes. Interesting stuff. Do they all these come from the file you mentioned in your first post?: GDG06 Minutes 251105

 

I'm copying similar things from the minutes as I go through them and trying to group into one post

 

So you're grouping things from different files, based on topic? I get you. Thanks for letter me know.

 

and no mention of any problems with this class of antidepressant

"(Question 2d) The use of Tryicyclics The group agreed that Tryicyclics are good for pain and sleep."

 

and of course we need to warn people about bed rest

"It was suggested that the harmful effects of bed rest should go into the guideline before a diagnosis is made. It was noted that it is evidence based and it was agreed that it should go into the guideline."

and

"Recommendation 29 Discussion formed around the risks associated with prolonged bed rest and the need for the wording in this recommendation to be changed to ensure that correct advice is given. Revised Recommendation In the absence of a definite diagnosis and/or while waiting for referral, advice and symptom management should not be delayed until a diagnosis is made."

and

"When an acute infection is followed by excessive fatigue, the person should receive advice on how to promote recovery. The advice should focus on sleep management, risks of prolonged bed rest (e.g. deterioration in muscle function), and a gradual return to a normal daily routine"

 

and specifically argue against strategies that some patients do find useful

"Strategies for which there are no evidence include •

those which encourage maintenance of activity levels at substantially less than full capacity in order to have reserve energy for the body to heal itself (can be known as the envelope theory)as there currently is no evidence of benefit. However, there is considerable patient support for this (particularly for people with severe symptoms of CFS/ME), and research is currently being undertaken to evaluate the effectiveness of this approach. •

those which encourage complete rest (cognitive, physical and emotional) during significant increases in symptoms (a ‘set-back’)."

 

Patients may not agree with the recommendations but tough - we followed NICE methodology

"Commented that psychiatric bias is part of a historical ideological debate. Most patients are just interested in getting better and the GDG should provide a robust response to these comments in the GDG’s defence stating that the GDG have followed NICE methodology.

Commented that there is no way the GDG can change people’s view but it should be stated that the guideline has followed NICE methodology."

 

It's ridiculous to say that they can only give the group a summary - these papers are being used to define the national treatment guidelines - surely they can pay for journal access or email the authors!!

 

I wonder which evidence showed that bed rest for people with ME is harmful?!

 

and if you want something included but don't have any evidence, then just argue this (from the Behavioural subgroup)

"Concerns were raised that interventions/therapies without evidence base are not ignored. As they are currently being used, it would be better to address them Page 4 of 12 rather then allow any bad practice to continue. Areas such as pacing will be included or at least referenced to in the work the sub-group are preparing"

 

I am not expecting to put myself forward as a committee member but I am very happy to hover behind providing any input that might help.

What I can say straight off is that not making primary source material available to committee members is inexcusable. There cannot be any copyright issues. As long as nobody as selling the papers copying documents goes on all the time in science without any problems. I can email copies to all lay members and the NICE staff can be asked if, this being the case, they would be kind enough to save me the bother.

The NICE staff need to be made aware right from the start that this time the lay members are backed up by top level scientific advice - mostly in fact from other lay members in the patient community. But if they are more impressed by academic credentials we can provide that as well.

We just need to hammer home:

There is no reliable evidence for CBT and GET and the recommendations need removing.

If the lay members just repeat that and only that for two years then I think the NICE people (!) will have to take note.

 

hear hear

 

If it exists, I imagine it would show a correlation between severity and bed resting. Of course, it is a well established fact that (certain) researchers are free to choose a direction of causality in whichever way is most convenient without need of further evidence.

 

Sounds like there is a lot of interesting stuff in these files. Thanks for going through them @ukxmrv .

 

eta: I think I've put this on the wrong thread

"Evidence submitted by Professor Malcolm Hooper (NICE 07)
This memorandum relates to the work of NICE in one specific area, namely its Guideline on the management of adults and children with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis ("CFS/ME") currently in preparation, a draft of which was issued on 29 September 2006."

"The evidence on which NICE has relied for the production of its "CFS/ME" Guideline has been provided by a small and unrepresentative group of self-styled "experts" and their adherents who study a heterogeneous patient population, resulting in flawed conclusions".

"They are known colloquially as the "Wessely School" after their prime mover Professor Simon Wessely of Kings College Hospital and the Institute of Psychiatry (ref: Hansard [Lords] 19 December 1998:1013).
Key members are Professors Michael Sharpe, now at Edinburgh, and
Peter White of St Bartholomew's, London
(who holds the "CFS/ME" reins at the Department for Work and Pensions, whose own forthcoming DWP Guidance about "CFS/ME" has been rejected as unfit for purpose by a coalition of ME charities).

The work of the Wessely School on "CFS/ME" has been stringently criticised in the international literature for flawed methodology; for use of a heterogeneous patient population (studies using mixed populations are not useful unless researchers disaggregate their findings);

for selective manipulation of others' work, claiming it supports their own findings when such is not the case;
for their focus on the single symptom of "fatigue" whilst ignoring other significant signs and symptoms associated with the cardiovascular, respiratory, neurological and immunological systems;

for generating conclusions before generating the data to support such conclusions;
for advising Government bodies that the reported biomedical abnormalities "should not deflect the clinician away from the biopsychosocial approach and should not focus attention towards a search for an "organic" cause", and
for their recommendation that no advanced tests should be carried out on "CFS/ME" patients when it is those very tests that reveal the unequivocally organic nature of the disorder."

"NICE has limited itself to—and based its recommendations for the management of "CFS/ME" on—a flawed 2005 Systematic Review from the Centre for Reviews and Dissemination at York, whose lead author was persuaded to change her mind between her 2001 article in the Journal of the American Medical Association (JAMA) and her 2005 Review for NICE"

anyone know anything about this?

"Wessely is further involved with PRISMA, a multi-national health-care company working for insurance companies. In its company information, Wessely is listed as a Corporate Officer"

"It is a matter of concern that NICE's chosen advisers on its "CFS/ME" Guideline Development Group include Dr William Hamilton, who has a published track record of believing "CFS/ME" to be a behavioural disorder. Moreover, he has spent 15 years working for the medical insurance industry and is currently Chief Medical Officer for a major medical insurance company, the Exeter Friendly Society."

"Another member of NICE's GDG is psychologist Dr Hazel O'Dowd who also subscribes to the "behavioural disorder" model. However, she has recently published a paper that ought to cause NICE to reconsider its recommendations, as it showed that group CBT did not bring about the anticipated improvements."

"Another NICE GDG member is Dr Fred Nye, who was forced to make a public apology after his Department issued an advertisement for therapists informing applicants that "CFS" patients have "perpetuating illness behaviour"; that they experience "barriers to understanding" and that therapists will be required to "modify patients' predisposing personality style"."


interesting read (sadly almost prophetic):
https://publications.parliament.uk/pa/cm200607/cmselect/cmhealth/503/503we79.htm

 

Where would we have been without Malcolm Hooper and Margaret Williams?

I particularly like the term heterogeneous patient population, which seems precise and accurate, rather than heterogeneous disease, which is unproven and therefor inaccurate.