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NICE Guidelines Review - Aug 2013

user9876

Senior Member
Messages
4,556
I'd never heard of the National CFS/ME Network and I'm not very familiar with BACME either - but both will need to be researched - what are they saying? what's their message? who are they? etc.
BACME seem like a terrible organisation. There is very little information on their web site but I believe they are chaired by Esther Crawley so you can guess their views.

They describe the PACE trial as
The PACE Trial represents the highest grade of clinical evidence – a large randomized clinical trial, carefully designed, rigorously conducted and scrupulously analysed and reported.

I expect they will be lobbying NICE for CBT and GET.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
This is a good point. Both Ampligen and Rituximab trials show improvements at least with some patients. Hence this provides support for theories that the immune system plays an important role. It would be good to have ME described as likely to be an immune system disorder or auto immune disease (not sure what words would be correct) as this would change doctors attitudes.

Hi, one of the other terms used is auto-inflammatory. Bye, Alex
 
Messages
13,774
BACME seem like a terrible organisation. There is very little information on their web site but I believe they are chaired by Esther Crawley so you can guess their views.

It is pitiful that we have NHS staff being 'educated' by an organisation whose chair claims that PACE showed a 30-40% recovery rate for CBT/GET. No wonder so many patients ended up being treated so badly.
 

biophile

Places I'd rather be.
Messages
8,977
BACME seem like a terrible organisation. There is very little information on their web site but I believe they are chaired by Esther Crawley so you can guess their views. They describe the PACE trial as: "The PACE Trial represents the highest grade of clinical evidence – a large randomized clinical trial, carefully designed, rigorously conducted and scrupulously analysed and reported." I expect they will be lobbying NICE for CBT and GET.

One wonders how a non-blinded trial without placebo control "represents the highest grade of clinical evidence". If PACE was a drug trial or a study on CAM, such a statement would be met with laughter.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
One of the huge things about Rituximab is not that its an accepted treatment, but that if substantiated it could shows that ME is a B cell mediated disorder. So its part of the scientific description of ME: it is highly probable that most of the ME symptomology is mediated by B cell related immune factors, and any hypothesis of causation must account for this.

Its a similar story with Ampligen. That might be approved early next year. As proven therapies go, the delay in approving Ampligen has meant it is much more highly substantiated as an effective treatment than nearly all new drugs.

Bye, Alex

Morning Alex,

I don't want to get into it about these potential treatments specifically, but any attempt to suggest that Rituximab if the clinical trials prove successful will prove ME = X are unlikely I would suggest to be considered by NICE or anyone else. Simply put with both Rituximab and Ampligen we just don't know what they say about what ME is (or isn't) for that matter.

NICE will I understand only consider research evidence that moves the understanding forward and is likely to fundamentally change the existing Guideline in some way. I can't really see how this might happen for either of the two drugs you mention at this time. I'm also not sure what effect XMRV might have had on matters pertaining to research that takes understanding in a new direction.

I wonder though what would happen if either Ampligen or Rituximab were 'approved' for use there must be some way in which NICE can review their Guideline in between the usual four year period.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
Not what you wanted but AFME have done some research using the FoI to see what different health authorities spend per patient with ME.

http://www.actionforme.org.uk/Resources/Action for ME/Documents/get-informed/NHS report Ignorance injustice and neglect.pdf

The report is quite long and I've not read it but page 24 gives a list of spending per patient with ME. Given the low levels of spending I think it would be fair to conclude many PCTs are not implementing the NICE guidelines. The latest PACE trial paper gives us some idea of costs.


Thanks. I did read all of their report when it was published. It was of course shocking but hardly a surprise. What struck me as also very sad was the simple fact that they had to resort to FOI requests for any of this data. However, it does reveal the extent to which the Guideline has simply not been implemented or even honoured across the country. There's no 'gold standard' service. Cornwall used to be thought of as one - and I think so did Leeds and South Tynes (?) - but we have both been altered terribly by recent cost-cutting and low priority neglect.

It's that that I'd like to try and focus on personally but I suspect implementation of the Guideline might be beyond the Review itself. Could be that any efforts attempting to address this would best be made to the 'new' health committees and/or GP commissioners in our localities. Unfortunately, as with the National Service Framework for Long term conditions (prior to it being made irrelevant) there is no accountability for a failure to implement. Unless you are able (as a patient group) to push for and/or self-fund an 'audit' and even then you can only hope that the commissioners do something about any findings - and in Cornwall they certainly haven't. It's all fudge.
 

peggy-sue

Senior Member
Messages
2,623
Location
Scotland
Can I interject a tiny bit?
The main concern of NICE is money and cutting costs.
Not providing services.

They are going to be overly interested in the paper which says GET&CBT are best value for money.

Know your enemy.

I can't help wondering about all the incredibly valuable CBTherapists who are wasting their careers on this, when they are so short of therapists in areas where they can be of use.
I put a request to my gp for emergency counselling when my Dad was diagnosed with pancreatic cancer and I was "going under" trying to care for him, but in charge of major life and death decisions.
I was put on an 18 month waiting list.
When a drug addict (including alcohol) decides it is time to quit and they need help, they need it NOW, immediately.
It's a case of strike while the iron is hot.
Putting these folk on waiting lists will only give the impetus to quit time to dissipate and will reduce the hope of success considerably.

Would it help in any way to point out that other services could be seriously enhanced by having extra staff?
Therapists are not cheap.
 
Messages
13,774
I've not had time to properly think about this thread, but my primary desire from NICE would be:

i) An acknowledgement that the value and efficacy of cognitive and behavioural treatments for CFS have been exaggerated in a way that has left many patients feeling unable to trust their doctors, and ii) a recognition that CFS patients are now entitled to be spoken to as honestly and clearly as is possible,
 

user9876

Senior Member
Messages
4,556
Can I interject a tiny bit?
The main concern of NICE is money and cutting costs.
Not providing services.

They are going to be overly interested in the paper which says GET&CBT are best value for money.

Know your enemy.

I can't help wondering about all the incredibly valuable CBTherapists who are wasting their careers on this, when they are so short of therapists in areas where they can be of use.
I put a request to my gp for emergency counselling when my Dad was diagnosed with pancreatic cancer and I was "going under" trying to care for him, but in charge of major life and death decisions.
I was put on an 18 month waiting list.
When a drug addict (including alcohol) decides it is time to quit and they need help, they need it NOW, immediately.
It's a case of strike while the iron is hot.
Putting these folk on waiting lists will only give the impetus to quit time to dissipate and will reduce the hope of success considerably.

Would it help in any way to point out that other services could be seriously enhanced by having extra staff?
Therapists are not cheap.


There is an interesting economic argument here which is when there are limited resources how do you best put them to use. Even using the figures given in their paper the gains are very small so it doesn't make a good use of the limited set of resources. I think you could put a similar argument around GET, I believe that there is a shortage of physiotherapists.

To a large extent I think that the NICE guidelines around CBT and GET have been ignored. The damage they do is they impression they give to doctors. I believe that in the nice guidelines they say CBT and GET can be useful in helping manage ME. However, there is so much publicity around PACE and claims of recovery that doctors havn't got that message. Its particularly dangerous when doctors tell people to go and do some exersies. Or paediatricians start "graded attendance therapy" where the get parents to force children to attend school and gradually increase attendance even when it makes them ill - using the threat of child protection proceedings to do this.

This started me thinking what simple goals do we want to achieve. I wrote down a few goals as they occured to me to start a discussion:

1) Change the description of the disease to state evidence for immune system failures and neurological problems (as suggested in the latest highlight notice from the MRC). This could be critical in changing the perception of ME.

2) State clearly that there are currently no effective treatements just management strategies. They should point out that management strategies should be choices for patients. I would include pacing, GET and CBT here - I don't see them dropping CBT and GET hence I think it is important that they emphise the lack of recovery data. I also think management should include advice on pain (inc drugs), diet, vitamin suppliments etc

3) A commitment to review Rutiximab and Ampligen when further trials are completed and FDA approval given.

4) Strong statements around the dangers of exersise and things like graded attendance therapy particularly when badly managed. This kind of statement is supported by evidence of patients experiance from the MEA surveys and I believe that White or Sharpe acknowledged in an interview that exercise can be dangerous when badly managed. These statements should be backed up with pointers to evidence of immune system changes on exersise.

5) They need to say that patients with ME should not be sectioned.

6) They need to say that children with ME should not be subjected to child protection proceedings. I think the advice given in the 2001 CMOs report was quite good here.

7) Better differencial diagnosis - There are a number of papers around suggesting people getting to CFS centres should have had different a diagnosis (inc things like depression and sleep disorders), so I think work needs to be done here.
 

user9876

Senior Member
Messages
4,556
I've not had time to properly think about this thread, but my primary desire from NICE would be:

i) An acknowledgement that the value and efficacy of cognitive and behavioural treatments for CFS have been exaggerated in a way that has left many patients feeling unable to trust their doctors, and ii) a recognition that CFS patients are now entitled to be spoken to as honestly and clearly as is possible,


I think it will be really hard to get an acknowledgement of their failures - people don't like to admit they are wrong particularly when they have built there careers on it.

It might be easier to get them just deemphasise these treatments and emphisise evidence of biological mechamisms.

The point i'm trying to make is we need to think through the politics and tactics.
 
Messages
13,774
I think it will be really hard to get an acknowledgement of their failures - people don't like to admit they are wrong particularly when they have built there careers on it.

It's something which we could so easily show is true though! That should matter more than the desires of those in power to promote a narrative which is favourable to themselves and their interests. Also... it's more a failing a certain researchers than NICE. Personally, I don't think NICE have been too bad given the state of CFS research.
 

user9876

Senior Member
Messages
4,556
It's something which we could so easily show is true though! That should matter more than the desires of those in power to promote a narrative which is favourable to themselves and their interests. Also... it's more a failing a certain researchers than NICE. Personally, I don't think NICE have been too bad given the state of CFS research.

I agree its stuff we can easily show. The problem with NICE is there will be supporters of PACE such as Esther Crawley on the guidelines development committee. so I think its about trying to manage their influance - for example pointing out evidence of the effects of exercise on the immune system.

I believe that over the next few (5) years a much better understanding of ME and its causes will emerge. I think there should be a leverson style public enquiry then into how the psychiatrists managed to kill off research and abuse patients for so long.
 
Messages
13,774
The problem with NICE is there will be supporters of PACE such as Esther Crawley on the guidelines development committee. so I think its about trying to manage their influance - for example pointing out evidence of the effects of exercise on the immune system.

I don't know much about the processes which occur around NICE, but hoped it would be more independent than that. Drat.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
Hi peggy-sue, I like both those papers, and I think that research like this must be taken into account. However, its far more important in a review like NICE to refer to things with some evidence of clinical effectiveness. Treating ME as an O&N stress disorder still has a lot of research to go for clinical use - they are still mostly theoretical models. It is good though that Maes and Twisk are comparing againt the (bio)psychosocial model, and also good that it brings in discussion of O&N stress, a major finding in ME and CFS. Its also worth noting that the work of Leonard Jason on definitions help define the usefulness of studies using the Oxford definition. Bye, Alex
 

peggy-sue

Senior Member
Messages
2,623
Location
Scotland
:redface:
I'm still only brainstorming, Alex! Yes, I love those papers too but - have you any idea the trouble I had finding them? Even though I knew of their existance? (It's easy enough to find the weasel's model.:mad: )

I still think the best way forward would be to point out that the current situation is NOT "good value for money"......
detrimental in the long term - and costing more in the long run.

But the facts and figures would have to be found and worked out.

And the "cost" in the long term could be a difficult one - given you'd have to consider which budgets were relevant.
NICE may not be concerned with the cost of welfare benefits.

It needs to be kept short and precise - and grab their attention.
 
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13,774
It does look rather less independent than I'd hoped.

Formerly a clinical specialist physiotherapist in ME/CFS at Barts and the London hospital trust, Ms Bavinton represents physios on the National Institute for Health and Clinical Excellence committee developing guidelines on CSF/ME, to be released in August. She also co-wrote the GET handbook for the Medical Research Council-funded PACE trial. PACE (pacing, graded activity and cognitive behaviour therapy: a randomised evaluation) is the first large-scale trial to test and compare the effectiveness of four of the main treatments for ME/CFS, including GET. The five-year trial involves 600 participants.

http://www.csp.org.uk/frontline/article/fighting-fatigue
 
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13,774
I don't know how realistic this is, but it would be good if patient organisations were to request that those on the committee not be those who want top be paid for the provision of certain treatments.
 

peggy-sue

Senior Member
Messages
2,623
Location
Scotland
As in conflict of interest? :thumbsup:
That's a good one to bring up!
Whether or not it will be noted is another matter....