Campaign to get the NHS to review the NICE guidelines

[Sasha]

I also saw a humane team at my specialist centre who steered me away from enrolment in PACE, even though they said I was eligible.

I have such mixed feelings about this issue. I'm scared for those patients who might be attending less enlightened practices; I'm scared for those patients who might lose a service full of clinicians itching to jump on the biomedical treatments wagon once it starts rolling.

I think all we can do is donate, donate, donate to good research and speed it up as fast as we can.

There'll be a big push on the NIH soon for research funding by advocates: even those of us overseas should support it, and do everything we can to support biomedical research in our own countries too.

 

[OverTheHills]

If we close down the clinics for Dr Bansal and Prof Newton and the few people trying to do some research on patients then we have no hope of getting anywhere - to put it bluntly. I might as well say goodbye to IiME. And in the paediatric sector at least I think it is important that there are specialists who at least know something about the natural history of the condition to advise parent. Otherwise we would have parents with kids with ME/CFS having to see a GP who knew nothing of the illness. And I know of a number of ME/CFS specialists who would be interested in trying other treatments if we had good evidence that they worked. Without people like Nigel Speight where would kids with ME have been in the past?

So yes, 'first do no harm'. Let's make sure we do not cut off our face to spite our own nose.

Edited to add - Me Sci got there first.... Ignore this post
There is no way I would want to see the tiny quantity of UK research we currently have reduced blocked or impeded. Agree with Sasha we must continue to donate our few £/$ to the real research and continue to try to raise awareness, support our own people. I wish there was something we could do politically as well.

I was unaware that there was any connection between the fatigue clinics the majority of UK patients are offered eventually, and the real researchers. Now you have pointed it out Prof Edwards, they must at least come out of roughly the same funding stream, so it appears we must put up with the majority of the spectrum ranging from honest but ineffective to patronising to actively harmful in order to retain the few determined, clever and sane individuals.

Thankyou for the warning Prof Edwards, I'll put the knife down while my nose is intact.

 

[msf]

Hmm, I don't see why a fair review of the ME guidelines should result in biomedical research into the disease being axed. Prof. Edwards argument about the correct way to do things also has little relevance to me and other patients who feel they have been let down by the system. What I am concerned about is the fact that the research is not yet at the point where it translates into treatment recommendations, In this respect, a review of the NICE guidelines would change little apart from possibly challenging the GET recommendation.

 

[Jonathan Edwards]

The trouble is msf that you may have no idea how easy it is to shoot yourself in the foot when clowns are in charge. In recent years patients with RA who are just taking old fashioned 'DMARD' drugs have tended to do very well - for the simple reason that if they were not doing well they would be changed on to the new biologic drugs that work better for severe cases. Some bright spark then does a study showing that you only need to be on a DMARD because all the people on DMARDs are doing fine. And so NICE very nearly decides to stop all funding for new biologcs because they cost 100 times as much.

A fair review of the NICE guidelines would come up with the idea that nobody has any cost efective therapy so the logical thing would be to shut down all services. Without NHS specialist clinics nobody can do any research - period.

And if a review of NICE would change little, what is the point? I am now puzzled.

 

[msf]

I meant a review at the present time - I think a review in a few years time might be much more productive, and I doubt you could run a campaign like this twice. I have little confidence in the NHS's ability to conduct a fair review itself, one of the things that makes this unlikely is the tendency to favour British research over that done in other countries. From what I have seen, the insularity of the NHS means that they will ignore foreign research as long as it hasn't been replicated in this country, which won't happen because they already have their own a priori beliefs about the illness.

 

[Jonathan Edwards]

I meant a review at the present time - I think a review in a few years time might be much more productive, and I doubt you could run a campaign like this twice. I have little confidence in the NHS's ability to conduct a fair review itself, one of the things that makes this unlikely is the tendency to favour British research over that done in other countries. From what I have seen, the insularity of the NHS means that they will ignore foreign research as long as it hasn't been replicated in this country, which won't happen because they already have their own a priori beliefs about the illness.

I quite agree that a review in a few years time would be a good idea if there are some positive suggestions to make.
And I agree that you don't get two goes at it so I would wait until there is ammunition. I don't think the NHS has any particular tendency to favour British research. I think the PACE situation is an anomaly. At the moment there isn't any research from anywhere else that would form the basis of a treatment recommendation anyway.

 

[charles shepherd]

I dip in and out of PR on an occasional basis and have just been alerted to this discussion.

As people presumably know, The MEA has been trying to get the 2007 NICE guideline on ME/CFS replaced by recommendations on management that reflect the heterogeneity of both clinical presentations and disease pathways that are involved in everything that currently falls under the ME/CFS umbrella - which out in the real world is what NICE regards as its remit.

We have been trying to take this forward:

1 by our submissions to NICE,

2 through political pressure involving the APPG on ME - and our general election pro forma letter that people can use to write to election candidates also refers to revision of the NICE guideline,

3 through the Forward ME Group - where our meeting with Professor Baker in June last year resulted in what we regarded as being a very clear admission that the NICE guideline needs replacing.

Unfortunately, this is no longer a decision for NICE - they will only revise a guideline when asked to do so by NHS England. And our understanding is that NHS England have no plans to to ask for the ME/CFS guideline to be revised.

So the next step is to meet with NHS England to see if we can persuade them to do what is needed.

There is a fairly limited role for politicians here - because they will quickly tell you that they do not instruct NICE on what they ought to be doing. But, 'behind the scenes' if they thought NICE was getting something badly wrong, I'm sure the message would get through.

So I'm open minded about a signature gathering campaign. If you got huge number of signatures it might have some effect. If the number was small, it could even backfire - with NICE turning round and saying there is no pub[ic support for a new guideline……...

 

[charles shepherd]

Minutes for the Forward ME Group meeting with Professor Baker:

http://www.meassociation.org.uk/201...statement-by-the-me-association-10-july-2014/

Which help to explain why we are where we are…...

 

[Aurator]

I dip in and out of PR on an occasional basis and have just been alerted to this discussion.

As people presumably know, The MEA has been trying to get the 2007 NICE guideline on ME/CFS replaced by recommendations on management that reflect the heterogeneity of both clinical presentations and disease pathways that are involved in everything that currently falls under the ME/CFS umbrella - which out in the real world is what NICE regards as its remit.

We have been trying to take this forward:

1 by our submissions to NICE,

2 through political pressure involving the APPG on ME - and our general election pro forma letter that people can use to write to election candidates also refers to revision of the NICE guideline,

3 through the Forward ME Group - where our meeting with Professor Baker in June last year resulted in what we regarded as being a very clear admission that the NICE guideline needs replacing.

Unfortunately, this is no longer a decision for NICE - they will only revise a guideline when asked to do so by NHS England. And our understanding is that NHS England have no plans to to ask for the ME/CFS guideline to be revised.

So the next step is to meet with NHS England to see if we can persuade them to do what is needed.

There is a fairly limited role for politicians here - because they will quickly tell you that they do not instruct NICE on what they ought to be doing. But, 'behind the scenes' if they thought NICE was getting something badly wrong, I'm sure the message would get through.

So I'm open minded about a signature gathering campaign. If you got huge number of signatures it might have some effect. If the number was small, it could even backfire - with NICE turning round and saying there is no pub[ic support for a new guideline……...

Thank you for shedding some light on this.
I'm left with a small knot that I can't immediately disentangle:

Given that Professor Baker, NICE's Director of the Centre for Clinical Practice, stated last year that:

• "The (NICE) Guideline failed to address the real issues in ME/CFS";
• "It does not promote innovation"; and
• "It had a disappointing impact on specialist care and commissioning issues";

and that, in your own words, Professor Baker "accepts that the NICE guideline on ME/CFS is no longer meeting the needs of people with ME/CFS", presumably this means the MEA's submissions to NICE are falling on largely receptive ears, and NICE need little convincing as to the reasonableness and desirability of the changes you propose.

With this in mind, I find it slightly puzzling that if NHS England were to be persuaded to ask NICE to review the guideline, NICE might allow something as tenuous in its possible interpretation as a lukewarm response to a signature gathering campaign conducted around the same time to persuade it not to act on its own previously and unambivalently stated position: namely that the current guideline "failed to address the real issues in ME/CFS".

Is it NICE's policy to introduce guideline changes that NICE itself has acknowledged to be necessary only if the patient group concerned can succeed in mustering a certain show of public support for those changes, and regardless of how disadvantageously placed that patient group may be to mount signature campaigns in the first place?

 

[Jonathan Edwards]

Thanks to Charles for clarifying what MEA have been doing. As so often with problems like this the more you look into it the more complicated it seems. To go back to what has been discussed I think I would separate out two different issues.

The first is the best way to lobby through the parliamentary system and the NHS structure. My feeling is that there are lots of useful ways to do this, including Charles's approach of face to face meetings with relevant people, working through the standard lobbying channels and also internet or letter or article based campaigns from patient groups to raise awareness of plight of PWME. What I am dubious about is relating this to electioneering partly because there is nothing specific that a party can promise to do (as Charles says they will say they cannot instruct NICE) and partly because I think it will get lost in the rough and tumble of election politics and may even be ridiculed - as so many things are in the newspapers.

The second is whether it is a good idea to pressure NICE, it would seem via NHS England, at this point. If Charles and colleagues have been making progress on this with face to face discussion and have made some progress in getting an admission that things are not ideal I would strongly support that. What worries me here is where is the real road block and if you try to free things up at one point do you end up with a worse jam some where else so to speak. My fears about tinkering with the guidelines may be unjustified - maybe it would at least be a step forward to say we need physiotherapists to use pacing instead of GET and ask psychologists to take a more general supportive role - but I do worry that we are dealing with a government that takes every excuse to further reduce spending.

Prof Baker's comments seem to me interesting in that in a way he is saying that this is not a NICE issue anyway. The NICE guideline fails to address the real issues of ME/CFS - maybe because what is really needed is enough training and provision of staff to run a service (money) and research into how actually to address the issues (money). The guideline fails to promote innovation, but NICE is not about promoting innovation, it is about making sure money is only spent on well proven methods. It is also supposed to ensure that everyone gets the proven treatments but it has no mechanism for enforcing that. In the current fragmented PFI drive service we have the only mechanism for enforcement seems to be closing down hospitals like Mid Staffs when things get rock bottom. And the fact that Prof Baker felt that the guideline had had a disappointing impact of services seems to bear out the fact that in terms of raising standards NICE is completely toothless in the face of a government that does not want to spend money.

So I fully support Charles's attempts at getting change - partly because I know that he is very adept at reasonable but forceful argument. But I also suspect that we still desperately need to shift the perception within the medical profession itself towards a more biologically driven approach to the disease. And that means getting some hard evidence to use to persuade them.

 

[lansbergen]

But I also suspect that we still desperately need to shift the perception within the medical profession itself towards a more biologically driven approach to the disease. And that means getting some hard evidence to use to persuade them.

Right. Without that doctors are handcuffed.

 

[rosamary]

Right. Without that doctors are handcuffed.

The issue which concerns me is that if a large number of patients diagnosed with ME or CFS by doctors (gps) are later found to have something else eg MS, why aren't patients with somatoform illness 'found to have something else' if the medics doing the screening for other conditions actually believe it is somatoform.

Why is it that is appears to be perfectly acceptable to leave them with a CFS diagnosis?

Seems stupid to me.

 

[msf]

Dr Shepherd, what benefits do you think a change in the NICE guidelines would have now? Are you trying to change the guidelines to help change the mindset of the NHS re: ME, so that future research and treatments will have a better chance of being approved?

 

[msf]

Yes, I agree with Mary, one of the problems with the NICE guidelines is that it proscribes certain tests for ME patients, and this may prevent these patients receiving a diagnosis of an illness for which there is treatment.

 

[msf]

Rosamary, sorry

 

[charles shepherd]

Dr Shepherd, what benefits do you think a change in the NICE guidelines would have now? Are you trying to change the guidelines to help change the mindset of the NHS re: ME, so that future research and treatments will have a better chance of being approved?

Can I answer your very valid question by first saying that we are in the final stages of writing up the results, conclusions, and recommendations that emerge from our 'patient evidence' survey that asked a large number of questions in relation to CBT, GET and Pacing - where these 3 approaches to management had been delivered in either in an NHS clinic or in a self-management setting.

We received a huge amount of data, including detailed comments from many of the people who took part.

It has therefore taken a considerable amount of time to get all this data analysed (including input from a medical statistician) and presented in a form that people will understand in a report. At present, the report stretches to nearly 250 pages - including all the annexes.

One important part of the report will be the way in which we translate the findings and conclusions into recommendations on management that will go to NICE, NHS England, DoH etc in due course.

If NICE were to then move to produce a management guideline on ME/CFS that was based on our recommendations, and really did reflect the wide variety of clinical pathways and disease pathways, and emphasised the need to treat people with ME/CFS as individuals in relation to their symptoms, stage and severity of disease then we may well be looking at something we would want to help with and approve.

But if NICE are going to stick to the rather inflexible methodology of really only looking at 'evidence based medicine'
and largely ignoring patient evidence, and not taking very much notice of research relating to possible causation and sub-grouping/phenotyping, then we may end up with a revised guideline that isn't much better than what we already have.

You will see that I deliberately use the term ME/CFS (as I normally do) because out in the real world, in our current state of knowledge, there is no way that anyone is going to persuade NICE to carry out any form of sub-grouping under the ME/CFS umbrella.

But if the US medical establishment moves to adopt SEID in a serious way, then this is likely to have some effect on NICE (and NHS England)

Sorry - there isn't a simple answer to your question!

 

[user9876]

NICE seem to have some issues around over promoting CBT. Its not just for ME but there has been quite a debate around the NICE guidelines which recommend CBT for psychosis even though a meta analysis over trial results suggest it has no benefit. CBT trials for psychosis or schizophrenia appear to spin their results almost as much as for ME also with help from the SMC. Its worth looking at Keith Laws paper on this and comments he and those promoting CBT are making.

I wonder if there is a general governance issue that should be raised with NICE around to composition of committees that lead to poor advice. I think there has been comments in threads suggesting politicians shouldn't be involved but I wonder if it is worth approaching someone on the health select committee (perhaps the chair) over the issue of the quality of advice given by NICE. After all they should be addressing governance issues where they appear to be failing.

But if NICE are going to stick to the rather inflexible methodology of really only looking at 'evidence based medicine'
and largely ignoring patient evidence,

I look forward to reading your report. I think there is a point that safety information from patient reports should be taken very seriously even if it anecdotal claims of recovery and benefit are not. Take two drug scenarios -
Side effects - A trial may be too small to show particular side effects or the measurement period and follow ups may be too short hence patient reports of issues become essential in ensuring drug safety. There have been particular issues around drug safety where side effects can be dismissed as normal symptoms and hence fail to get reported. For example, this happened with the increased suicide rate associated with certain anti-depressants when given to adolescents. The data was in the trial data but it didn't come out until concerns were raised after the drug was in use and then only after a detailed independent analysis. The importance here is to push for open data from trials but also taking patient safety data seriously.
Manufacture - If there were a bad batch of drugs or a dodgy manufacturing process (or counterfeit drugs getting into the normal delivery process) then this would reflect on patient reported safety issues but not be reported in a trial. Note that it could even be a factor of how the manufacture process was scaled up from that sufficient for a trial to a mass produced product. Now look at something like CBT/GET and even pacing - if they are safe in a trial but patients report safety issues in practice then this leaves a big question as to why which needs investigating. I know that other industries have found it very hard to scale out services provided by individuals in a consistent and reproducible manner. So this would need to be addressed in any guidelines that would need to be more specific about exact protocols and safety warnings. It is something that worries me about the way White and others promote GET as patients pushing against limits even thought the PACE protocols seem to suggest a much more relaxed view.

My point is that we should be arguing that some forms of safety data can only be extracted from patient reports and these need to be properly considered.

 

[ukxmrv]

I think that the safest thing to do would be to ask for the repeal of the NICE guideline.

Asking for them to be revised isn't going to be of any benefit as it was the brief from the DWP and the NICE procedures to create the Guideline which was wrong. That hasn't changed and the petition won't change that.

We can't have a Guideline for a disease written where

1. The DWP didn't specifiy what criteria of ME or CFS they wanted a guideline on

2. Because of the paucity of research into ME and CFS of any criteria there simply weren't many clinical trials to assess as treatments

3. The Guideline Development Group contained too many medics with vested interests in CBT and GET and faulty illness beliefs like deconditioning and somatisation

4. Evidence was defined as RCT's being the gold standard and the evidence from doctors who treated the disease or who had treated the disease was not taken seriously or considered of equal weighting.

 

[msf]

Thank you for your in-depth reply, Dr. Shepherd. I appreciate the fact that there isn't an easy answer to the question I asked.

UKXMRV, I didn't realize that the biases were in the DWP, that would seem to be much harder to change, although I think a sufficiently popular campaign could potentially still achieve that. I think Dr. Shepherd has the best grasp on which strategies are most likely to succeed, so hopefully he sees some way of moderating the influence of the DWP.

 

[charles shepherd]

I should add that there is, of course, a major hurdle in getting the 2007 NICE guideline replaced (or even reviewed) and that relates to the position of the UK medical establishment, which is not demonstrating any desire to join the patient community in asking for this to take place.

I would refer, in particular, to the the comments made by Dr Alastair Miller (who represents BACME) when he came to speak at a Forward ME Group meeting that was held at the House of Lords in January

The Minutes for the meeting are here:

http://www.meassociation.org.uk/201...n-speaker-dr-alastair-miller-20-january-2015/

Comments and discussion relating to PACE and NICE (from the above Minutes) included:

Dr Miller made it clear at this meeting that BACME was not pressing NICE to review or revise the guideline:
2.3 Turning to treatment Dr Miller said the PACE trial had given an evidence base to the treatments already being given in the ME/CFS centres (ie CBT and Graded Exercise). BACME was currently drafting a document on the control of symptoms. He was aware of controversy of the around the NICE Guideline but unfortunately there was not another treatment with an evidence base.

2.4 Dr Charles Shepherd referred to Forward-ME’s meeting with Professor Mark Baker of NICE. We had voiced our concerns and he didn’t want to dismiss any of them. He seemed to agree there should be a revision of the Guideline, but apparently that decision was no longer up to NICE but a matter for NHS England, and there is already a backlog of other guidelines to consider. So the ME/CFS Guideline was now on the “static list” and apparently nothing could be done unless NHS England could be persuaded to change its mind. He would be interested to know the views of Dr Miller and BACME on this.

2.5 Dr Miller said he accepted the Guideline had its limitations but there was not yet an evidence base for other therapies. What were members hoping for in a revised guideline? Dr Charles Shepherd suggested a less dogmatic, “one size fits all” approach. Sue Waddle said that the current guideline did not draw attention to the devastating effect Graded Exercise could have on patients. Vigorous exercise could result in relapse. Charles Shepherd said the problem was not just CBT and GET, there were other shortcomings and omissions in the Guideline. For example NICE did not mention immune dysfunction and the autonomic nervous system. Dr Miller said the guidance BACME would be putting out should help there. Professor Julia Newton had contributed on the autonomic nervous system and measures that can be taken to treat that.

2.6 There was further discussion between Dr Miller and members about the need for better guidance, including the considerable numbers of patients referred who were found to have conditions other than ME. Dr Miller pointed out that he had said in the AFME magazine that any patient referred as having ME had to be approached with an open mind. BACME had no direct contact with NHS England and he was not sure it would be helpful to revise the NICE Guideline at this stage. Data from the NOD study was showing that some patients were worse after CBT or GET, some remained the same and at least one third showed improvemen