Bad news to the MEA from NICE: no review considered necessary

[medfeb]

In addition to unblinded trials, subjective outcomes, substantial reports of harm, and a claimed therapeutic mechanism of action that does not fit what we know about the disease or the results of Rituxan, can this also be fought on because of poor patient selection? The AHRQ Evidence Review Addendum found insufficient evidence for GET and barely any for CBT once Oxford studies were eliminated. And they can not claim PACE is also a Fukuda study because only required symptoms for one week, not 6 months which they even acknowledged could change prevalence.

Possible problems with doing this could be that this is a US study and the Addendum was not put into the Annals where the original study was placed. Trying to get that addressed but so far no luck.

 

[dangermouse]

NO treatment is better than the wrong treatment!!

I agree.

 

[Binkie4]

I have read ( and reread) the correspondence between MEA and Michelle Whittaker of NICE

http://www.meassociation.org.uk/201...ne-review-and-its-not-good-news-05-july-2017/

and tried to phrase its conclusion in a way I could understand, namely

1. No decision has yet been finalised as to whether or not CG 53 needs to be reviewed

2. If the panel has not recommended that a review is appropriate then a 2 week consultation will take place from July 10th, effectively for the stakeholders to appeal/ influence the decision

3. If the panel had concluded that a review were appropriate, then no consultation would be taking place and the process would be proceeding directly to a full review


We seem to now be operating within points 1 and 2, so the two weeks from July 10th allow for stakeholders to try to appeal/influence the decision of the panel ( identities unknown) with two outcomes possible.

a) CG53 does not need to be reviewed- finalisation of the apparent current position of the panel
b) a review of CG 53 will take place

We may believe that option b is not on the agenda, and past history suggests this is so.

Have I got the options clear? ( excuse bolding, done to emphasise the word finalised but couldn't be undone)

And is there anything that we can usefully do in these 2 weeks? Suggest lobby stakeholders, charities, etc. We are probably on a losing wicket but try and try again.

CG53 is devastating to pwme

I too agree that no treatment is better than damaging treatment.

 

[trishrhymes]

There are 49 CFS clinics in England.
Most of these are delivering primarily CBT and GET, and have several staff.

If you take the likely operating costs of 5 staff, and the fact they're mostly delivering placebo (at best) treatment, this is well over the cost of PACE per year.

Since ME/CFS is specifically included in the latest guidelines for commissioning groups on treatment for MUS (medically unexplained symptoms) it's possible all these CFS clinics will be closed down, and we'll only be offered generic CBT by poorly trained therapists. Not sure which is worse.

 

[charles shepherd]

NICE will obviously have to take note of what happens during the consultation with stakeholders

This is a link to the ME/CFS guideline stakeholders list
http://www.meassociation.org.uk/shop/management-leaflets/cognitive-dysfunction/

A significant proprtion of these stakeholders are hospitals and institutions where some of the employment is dependent on carrying out the sort of behaviour management programmes that are recommended by NICE (i.e. CBT and GET)

So it could be argued that there is conflict of interest here….

Other stakeholders include the various Royal Colleges and other institutions that will probably support the 'no update' decision

I fear that we are now fighting a losing battle….

CS

 

[charles shepherd]

It's a worry the MEA still have clinics such as KCL, Barts and Crawley's Bath Clinic on their list.
http://www.meassociation.org.uk/specialist-services-throughout-the-uk/

They do suggest: "If you spot any mistakes or wish to notify us of any omissions, please email our head office.". I think most of us could come up with a whole list of 'mistakes'. This is an ME patient charity essentially guiding people to clinics which are known to be CBT/ GET based. (I do not consider this comment 'off topic'. )

Could I ask why you have (? deliberately) chosen to omit the fact that this NHS referral service directory lcarries a very clear health warning right at the very start:

PLEASE READ THIS STATEMENT BEFORE BEGINNING YOUR SEARCH

Most of the NHS clinics for people with ME/CFS in this MEA directory base their management programme on the possible use of cognitive behaviour therapy (CBT) and/or two differing approaches to activity/energy management known as graded exercise therapy (GET) and Pacing.

We suggest that you download and read the summary of the recommendations from the MEA ‘patient evidence’ report on CBT, GET and Pacing before deciding which of these approaches to management you think would be acceptable and may be helpful in your situation.

You could also take a copy of the summary of the MEA Report to the clinic if you have any questions or concerns about the sort of management programme that is being offered or recommended – if it involves CBT or some form of activity management.

In line with what is known as informed consent, people should not be coerced or persuaded into taking part in any form of management (drug or non-drug) where they have concerns over acceptability, effectiveness or safety – all of which should be discussed between doctor and patient before a decision on management is made.

Dr Charles Shepherd
Hon Medical Adviser, ME Association

PS I think this subject is off topic and would be far better discussed elsewhere on PR. There have, incidentally, been numerous discussions and explanations as to why we provide a COMPLETE list of all the UK NHS hospital-based referral centres - mainly because we believe that people with ME/CFS should have access to this information and the very clear health warning that accompanies it.

 

[arewenearlythereyet]

I agree.

I agree too

 

[Deepwater]

A change of tack may be needed.
This is deliberate and wilful, not a failure of understanding, not at this point.
We need the whole media, the whole population, on our side, otherwise nothing will budge.

 

[Invisible Woman]

So, what can we do?

Write letters?

Petition?

Is there anything that I as a pwME can do?

edited to add: @Mary has done some fine work as discussed here: http://forums.phoenixrising.me/inde...re-me-cfs-amazing-response.52657/#post-871836
taking on the Mayo Clinic.

Would something similar to the powers that be make any difference? If so who to? And could a form letter be drafted for those too brain fogged to write one themselves?

 

[Deepwater]

I'm afraid I do not believe that petitioning or writing letters to any official body will do anything. They have heard it all before and don't care. In fact, they will go to great lengths to defend the status quo. I have to admit, I was already suspicious that NICE may have brought forward their review for bad reasons, i.e to avoid having to take account of the Phase III Rituximab trials. I'm now certain of it. The result was decided before they started. Esther Crawley is a member of the Guideline Development Group, for heaven's sake:-
https://www.nice.org.uk/guidance/cg53/chapter/Appendix-A-The-Guideline-Development-Group

 

[Deepwater]

As for petitions, there was one recently to have a parliamentary debate "on the absence of an effective treatment for ME". The election was used as grounds for closing it early, and last week the following statement was forwarded to signatories:

"The Government accepts the World Health Organisation’s classification of CFS/ME as a neurological condition of unknown origin.

Many potential causes for CFS/ME – including neurological, endocrine, immunological, genetic, psychiatric and infectious – have been investigated, but the variety of symptoms and the range of their severity cannot be fully explained. As the symptoms of CFS/ME resemble those of other forms of debilitating illness and there is no test with which to make an accurate diagnosis, it is not always easy to diagnose single cases of the condition. Diagnosis relies on clinical observation of symptoms by healthcare professionals.

For those affected, it is important that they receive the right diagnosis and that the treatment and support they receive are tailored to their symptoms, needs and circumstances. NHS clinical commissioning groups are responsible for ensuring that local people affected by CFS/ME are able to access appropriate care. To support local services in the diagnosis, treatment and support of patients with CFS/ME, in 2007 the National Institute for Health and Care Excellence (NICE) published a clinical guideline on the management of CFS/ME in adults and children, which sets out best practice on the care, treatment and support of patients with CFS/ME. NICE is the independent expert body responsible for developing robust, evidence based guidance for the NHS to design services that are in line with the best available evidence.

The NICE guideline on CFS/ME recommends treatments, such as cognitive behavioural therapy (CBT) and graded exercise therapy (GET) approaches, that have the clearest research evidence of benefit. However, it does not detract from the right of patients to be involved in decisions about their treatment. The guideline recognises there is no one form of treatment to suit every patient and it does not force patients into treatments they do not want. Instead, it emphasises a collaborative relationship between clinician and patient, that treatment and care should take into account personal needs and preferences, and that healthcare professionals should recognise that the person with CFS/ME is in charge of the aims of the treatment programme. It is also important to clarify that the effectiveness of CBT as a treatment for CFS/ME does not make assumptions about the nature of the illness. CBT is used to help and support people through physical illnesses and is used widely to manage many medical conditions such as arthritis, heart disease and chronic pain.

NICE last reviewed the guidance with its stakeholders, including CFS/ME charities, in 2013. The review found no update was required and at that time no major ongoing studies or research were identified as due to be published in the next three to five years. The full guideline may be viewed on the NICE website at the following link: www.nice.org.uk/guidance/cg53

Recently, NICE has been made aware of three US reports that have indicated there are likely to be changes in diagnostic criteria that could have an impact on the CFS/ME guideline recommendations and decided to start a check of whether the guideline needs updating. NICE has also been made aware of new information about the 2011 PACE trial, which highlighted CBT and GET as safe and effective treatment options for people who have mild or moderate forms of CFS/ME. At the time, NICE concluded that the results of the trial supported its existing guidance, but it will now also consider that new information as part of its check of the guidance. NICE plans to set out its decision regarding an update shortly. More information can be found at the following link: www.nice.org.uk/guidance/cg53 "

In other words, all hogwash and whitewash.

We need to get the media involved in a huge way, because this lot will do nothing unless public outrage is so strong they are left with no option. (The importance of public opinion is, of course, is why they themselves are always going to the newspapers.)
Perhaps we will need an ME/FS Media Centre. We will also need brave, outspoken scientists and the support of a few really good and influential journalists. I am housebound miles from the centres of action, and I have no medical expertise, so I'm not the person to take this on, but this, I believe, is what it needs.

 

[NelliePledge]

I suspect that once the MUS 'treatment program' is rolled out CFS or fatigue clinics might become 'redundant'.

The one at Nottingham City Hospital was due to close this month to be replaced by a community based service covering CFS and Pain. Not seen any further info since it was announced in Feb 17.

 

[NelliePledge]

Forgive me if I'm misunderstanding your complaint lilpink, but when I click on the MEA link you included in your earlier post...



...there's a pretty prominent disclaimer before you get to any contact details:



(It's possible this text was added fairly recently - the webpage was updated on 3rd July - so if you're looking at a cached version of the page, you may not have seen it)

The disclaimer was added months ago

 

[Chrisb]

"How many scientists does it take to shift a paradigm?"

 

[Binkie4]

http://www.meassociation.org.uk/shop/management-leaflets/cognitive-dysfunction/


@charles shepherd -cannot find the list of stakeholders on this link as described.

Please could you post the correct link. All I can think of as an individual with ME is to review the list and see if there is anyone I can contact.

Anyone else any bright ideas?

 

[Jenny TipsforME]

A significant proprtion of these stakeholders are hospitals and institutions where some of the employment is dependent on carrying out the sort of behaviour management programmes that are recommended by NICE (i.e. CBT and GET)

So it could be argued that there is conflict of interest here….

Other stakeholders include the various Royal Colleges and other institutions that will probably support the 'no update' decision

CS

There are at least 2 patient organisations registered as stakeholders who don't yet appear on the list: ME Action Network UK and Hope for ME and Fibro NI. Can we think of other patient orgs who we think should be on the list, to balance out the services with potential vested interests in maintaining the status quo?

This is the public list at the moment https://www.nice.org.uk/guidance/cg...algic-encephalomyelitis-list-of-stakeholders4 they seem to want national patient orgs, which means we're outnumbered by the service organisations/NHS trusts which can be local. I don't think all the local support groups can suddenly register as stakeholders for example.

I would hope that if all the patient orgs are calling for a review this would count for something (you would think wouldn't you?!).

And is there anything that we can usefully do in these 2 weeks?

I'm involved in the ME Action Network UK response. Obviously we are people of very few spoons. It might be that you can help by collating evidence. I haven't been involved in these consultations before, so I don't know if there's a tight word count and if we can attach documents (do you know @charles shepherd ?).

For general advocacy purposes I can think of a few lists which would be worth creating and then keeping up to date.

I'm thinking lists containing the abstract information about research (copy and pasted into a document or spreadsheet, so not particularly cognitively draining as a task). Could be lists of:

-Nature of bio problems with objective evidence (recent, especially if UK research)
-Papers showing ME worse after exertion
-Papers critical of PACE
-Null results from CBT/GET

Patient surveys on CBT/GET could be another useful list, though won't be abstracts. Perhaps organisation, year, size, results, graph if they have one. We did look at patient surveys for correspondence about MAGENTA, so we may have enough information on this.

Potentially we can use this info for the NICE guidelines consultation, in an Appendix for various official letters, and for writing future articles. Send me a direct message if you're interested in contributing to this type of thing.

 

[slysaint]

This is still all there is on the AfME website:
"
Action for M.E. to call for review of NICE guidelines
June 27, 2017

Action for M.E. will be calling for a review of the National Institute for Health and Care Excellence (NICE) clinical guideline on M.E.

NICE has announced it will be holding a consultation on whether the guidelines on CG53 Chronic fatigue syndrome/myalgic encephalomyelitis (encephalopathy): diagnosis and management should be reviewed from 10 to 21 July. As a registered stakeholder on the guideline, Action for M.E. will be responding to this initial consultation stating that the guideline should be reviewed, based on patient experience and the need to consider up-to-date evidence on appropriate symptom management approaches.

While individuals cannot become registered stakeholders, Action for M.E. will ensure that we share the views of people M.E. as part of our response to this consultation. We will not know until 10 July what the precise scope of the consultation is – we'll post more information when we have it."

Funny how they always make out they are the only one doing anything

edit: see also this thread
http://forums.phoenixrising.me/inde...10-july-2017-until-friday-21-july-2017.52380/
AfME were not on the stakeholders list at that time

 

[Barry53]

I have read ( and reread) the correspondence between MEA and Michelle Whittaker of NICE

http://www.meassociation.org.uk/201...ne-review-and-its-not-good-news-05-july-2017/

and tried to phrase its conclusion in a way I could understand, namely

1. No decision has yet been finalised as to whether or not CG 53 needs to be reviewed

2. If the panel has not recommended that a review is appropriate then a 2 week consultation will take place from July 10th, effectively for the stakeholders to appeal/ influence the decision

3. If the panel had concluded that a review were appropriate, then no consultation would be taking place and the process would be proceeding directly to a full review


We seem to now be operating within points 1 and 2, so the two weeks from July 10th allow for stakeholders to try to appeal/influence the decision of the panel ( identities unknown) with two outcomes possible.

a) CG53 does not need to be reviewed- finalisation of the apparent current position of the panel
b) a review of CG 53 will take place

We may believe that option b is not on the agenda, and past history suggests this is so.

Have I got the options clear? ( excuse bolding, done to emphasise the word finalised but couldn't be undone)

And is there anything that we can usefully do in these 2 weeks? Suggest lobby stakeholders, charities, etc. We are probably on a losing wicket but try and try again.

CG53 is devastating to pwme

I too agree that no treatment is better than damaging treatment.

There is the thought that adopting a stance where it had to go to appeal would be the default anyway.

Some big questions are: who are "the stakeholders"?; who gets to decide who they are?; and will a list of stakeholders be published before the consultation period begins?

 

[slysaint]

Anyone else any bright ideas?

started a new thread http://forums.phoenixrising.me/index.php?threads/nice-question-time-basingstoke-19-july-2017.52669/
maybe someone could attend this?

 

[dangermouse]

Some big questions are: who are "the stakeholders"?; who gets to decide who they are?; and will a list of stakeholders be published before the consultation period begins?

I imagine there will be few surprises as to who the stakeholders are.

I think you hit the nail on the head with those BIG questions.