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

[medfeb]

In researching another topic, I stumbled on this page on the NICE site discussing its "Improving Access to Psychological Therapies" program. https://www.nice.org.uk/about/what-we-do/our-programmes/nice-advice/iapt

The bottom of this page includes a link titled "NICE guidance for conditions managed by IAPT" which includes a link to the NICE CFS/ME guidance.

I've tried to find out who is in that group but have not found much. But this document on the Commissioning guidance for MUS listed Rona Moss-Morris as the IAPT MUS lead - see slide 3. Not sure what that means or if she still is.

Am I reading this correctly? Is this group responsible for managing guidance for ME and does that mean they are the "experts" who made this latest decision? Who else is involved with this group? Would there be a lead for each of the conditions they manage?

Feel free to tell me if I am asking dumb questions!

 

[Deepwater]

Interesting comment from @Jonathan Edwards on the Tuller thread.....



I would like to hear more about this and if it can be done to doctors who else it can be done to. This statement seems to clearly add evidence to the theory that its not just one big ignorance disaster.

Indeed. One does has to ask oneself why the BPS model has been so aggressively defended by the GMC; why Wessely was appointed as a medical advisor to the Ministry of Defence, and whether it was just coincidence that he used his theories to deny, on the government's behalf, the biological reality of not just ME but also of Gulf War Syndrome and the illness suffered by the folks at Camelford in Cornwall as the result of poisoning of the water supply with aluminium, illnesses that, if properly recognised for what they were, could have landed the authorities with enormous bills for compensation? Is it coincidence that Wessely's career then took off to the dizzying heights on which he now sits?

What may or may not lie beneath in the case of ME, though, is IMO not something we need - or ought - to be worrying about now. We just need to realise that, for whatever reason, we have been stitched up and only public pressure can help us out.

 

[slysaint]

In researching another topic, I stumbled on this page on the NICE site discussing its "Improving Access to Psychological Therapies" program. https://www.nice.org.uk/about/what-we-do/our-programmes/nice-advice/iapt

The bottom of this page includes a link titled "NICE guidance for conditions managed by IAPT" which includes a link to the NICE CFS/ME guidance.

Feel free to tell me if I am asking dumb questions!

I don't think this is a dumb question; it answers one question namely why NICE cite FITNET as being one of the 'good reasons' to remove CFS from the static list.

"
What are we looking for?
Digital treatments that meet all of the following criteria:

• treat one of the clinical conditions covered by IAPT
  • depression
  • generalised anxiety disorder
  • social anxiety disorder
  • panic disorder
  • agoraphobia
  • post-traumatic stress disorder
  • health anxiety (hypochondriasis)
  • specific phobia
  • obsessive-compulsive disorder
  • body dysmorphic disorder
  • irritable bowel syndrome
  • chronic fatigue syndrome
  • medically unexplained symptoms not otherwise specified.
• use a treatment method with content that follows our guidance
• can be delivered as part of a blended model of care, supported by an IAPT therapist
• treat adults
• have at least one randomised control trial available for the condition being assessed
• is supplied by an organisation committing to keep ownership and responsibility to maintain and update the digital therapy technology.

Note the things I've put in bold.
Any change in the guidelines would make FITNET ineligible.

 

[Deepwater]

Interesting comment from @Jonathan Edwards on the Tuller thread.....



I would like to hear more about this and if it can be done to doctors who else it can be done to. This statement seems to clearly add evidence to the theory that its not just one big ignorance disaster.

Indeed. One does has to ask oneself why the BPS model has been so aggressively defended by the GMC; why Wessely was appointed as a medical advisor to the Ministry of Defence, and whether it was just coincidence that he used his theories to deny, on the government's behalf, the biological reality of not just ME but also of Gulf War Syndrome and the illness suffered by the folks at Camelford in Cornwall as the result of poisoning of the water supply with aluminium, illnesses that, if properly recognised for what they were, could have landed the authorities with enormous bills for compensation? Is it coincidence that Wessely's career then took off to the dizzying heights on which he now sits?

What may or may not lie beneath in the case of ME, though, is IMO not something we need - or ought - to be worrying about now. We just need to realise that, for whatever reason, we have been stitched up and only public pressure can help us out.

 

[Stewart]

@charles shepherd
any idea when there is likely to be an answer to this;

Written questions are usually answered within a week - but this is more of a guide than an absolute deadline.

 

[Daisymay]

We know that the NICE guidelines (which obviously pre-date PACE) are based on a very small number of research papers, involving very small numbers of patients, are of questionable quality and methodology, not least because of the diagnostic criteria used and because they ignore all the biomedical evidence which shows this is a physical disease.

The NICE Clinical Guideline: convincing evidence? Dr Neil Abbott, ME Research UK http://www.meresearch.org.uk/wp-content/uploads/2012/11/NICE_Evidence.pdf



The MRC and Professor Peter White (and by implication those who funded the PACE trial) have admitted that the evidence base for the guidelines was inadequate.

Dr Frances Rawle, MRC stated: "there was a lack of high quality evidence to inform treatment of CFS/ME and in particular on the need to evaluate treatments that were already in use and for which there was insufficiently strong evidence from random controlled trials of their effectiveness”. http://margaretwilliams.me/2011/hooper-reply-to-mrc-rawle_26jan2011.pdf

PACE Trial Protocol, March 2007, White et al used the lack of evidence for the efficacy of CBT/GET as a justification for the PACE trial: "The published trials of these treatments were however also criticized for being too small, too selective, and for using different outcome measures. No other treatments for CFS/ME have so far been shown to be helpful in more than one RCT [5, 12]." http://bmcneurol.biomedcentral.com/articles/10.1186/1471-2377-7-6

PACE Trial "The UK National Institute for Health and Clinical Excellence (NICE) recommend cognitive behaviour therapy (CBT) and graded exercise therapy (GET).2 Although this recommendation was supported by systematic reviews,4–7 supporting evidence remains restricted to small trials.4–7 Surveys by patients' organisations in the UK have reported that CBT and GET are sometimes harmful, and have recommended pacing and specialist health care.8,9" http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065633/#bib4



And of course, the AHRQ addendum, July 2016, concuded that in properly defined patients there is insufficient evidence for the effectiveness of CBT/GET in ME/CFS,. That being so, there is no scientific basis for the NICE guidelines.

Agency for Healthcare Research and Quality Addendum July 2016 found insufficient scientific evidence to support the use of CBT/GET in properly defined ME or ME/CFS patients. https://effectivehealthcare.ahrq.gov/ehc/products/586/2004/chronic-fatigue-report-160728.pdf

 

[CarolB]

I can confirm that Sheffield ME Group (now Sheffield ME and Fibromyalgia Group) emphatically subscribe to the biomedical view of ME. My first contact with the group was in around 2007, when Professor Malcolm Hooper spoke at the group's Annual Conference. I had only just been diagnosed. I eventually went on to become Vice-Chair, and then Chair, when Ute resigned due to ill-health. Sadly, I too had to resign due to family commitments and my own health, but I am still involved with the group on a daily basis as a Volunteer. During my long association with Ute, she never suggested, in my presence, that ME was anything other than a biomedical illness, but was always at pains to point out that the group was "not a campaigning group" in her words. It is true that the Board is now prepared to "nail their colours to the mast" so to speak and they came out, publicly, in support of the OMEGA Petiton. They also asked to be added to the list of signatories on the letter to the editor of the Lancet, but I don't think that actually happened.

Interesting. I've found out a very little about these patient representatives online. I'm sure @charles shepherd can tell us more.

Richard Eddleston. Runs the Nottinghamshire ME Self Help Group. This group seem to take biological approach, at least officially, but I can't find anything to indicate where Mr. Eddleston sits, or sat, in terms of treatment preferences.

Ute Elliott. Sheffield ME Group. Again, this group seems to accept biological basis, at least now, and they once had Dr Julia Newton to speak, but in general the guest speakers' talk topics indicate a strong bias in favour of dietary cures and relaxation. Back in 2006 Ms Elliott had invited another of the NICE Development Group members, Sheffield neurologist Dr Richard Grunewald, to speak to the Sheffield ME Group. At this meeting, Dr. Grunewald said -
“There is widespread ignorance about ME and the literature doesn’t help”. . . . Grunewald continued: “When the NICE Guidelines are published I hope this will be the beginning of a sea change. ME is always the result of stress. The way that has been found most effective is to address this with a multi-disciplinary approach including graded activity programmes and addressing psychological issues. Some models (of ME/CFS) are unhelpful such as the virus model. There doesn’t seem to be any doubt that for the majority of people there is not a viral trigger”.’ (ref., Margaret Williams, A Nice Dilemma, Part 1).
I also found this statement from Dr. Grunewald in 2009 regarding XMRV: "The idea that all CFS can be caused by a single virus doesn't sound plausible to most people who work in the field." (BBC News, 9 Oct 2009 http://news.bbc.co.uk/1/hi/8298529.stm )
So Ute Elliott may have been chosen as someone known and trusted by Dr. Grunewald, and he in turn seems to be a regular BPS psycho-neurologist ME denier.

Tanya Harrison (resigned). She actually resigned in protest because, although having effected some changes in the guidelines such as acknowledgement that CFS/ME is a crippling neurological condition, she could not force the treatment recommendations away from CBT ad GET (http://www.brame.org/contact2.html).

can

 

[CarolB]

I've just tried to post this comment on the MEA Petition, after signing in to Change.org, but it won't let me. It keeps telling me to try again. I signed the petition a couple of days ago, but I thought you could comment retrospectively. Is it because it's too long? Does anyone know?

"I was told that CBT was the treatment for ME/CFS. My life had been taken away by ME. I was desperate. I entered into the therapy with all the enthusiasm that I could muster. The Therapist said that he had never met anyone who had engaged so well with the treatment. It didn't work. I was despondent. I was offered GET, but refused.

The concept of GET seemed wrong-headed and crazy to me from the start. I concentrated on engaging in what little activity I could, when my body told me that it could.

I also suffered from extreme and life-limiting MCS and severe and immediate histamine reactions to half the foods in my (healthy) diet, as well as the neurological symptoms associated with ME.

Ten years on and I am continuing to improve. I can walk 5 miles at a good pace and can eat anything, but I still have mild MCS, which is now an inconvenience to me, rather than an illness.

PWME are not stupid. We don't collapse into our beds, in fear of activity exacerbating our symptoms. We don't get worse by joining Support Groups that legitimise our "illness beliefs". The information that my Support Group provided was instrumental to my recovery, when the NHS could give me none.

Why didn't the Lead GP, at my local CFS Clinic, know that adrenaline in local anaesthetics can make PWME more ill, sometimes pushing them into a relapse, when my local ME Group did, and they provided me with evidence that meant that I could have dental treatment, and eventually an hour long operation for a detached retina (I refused a general anaesthetic or sedation due to my MCS) without being made even more ill in the process? Why did my dentist not know this when she ignored my request for an adrenaline-free anaesthetic and included it without my knowledge? The unfortunate result of this, at least, made her realise that I wasn't making it up and she has now shared the information that I gave to her with our local dental hospital. Why do PWME consistently complain of this, many avoiding dental, or other procedures completely, not knowing that it is the adrenaline in the anaesthetic that is making them ill? This is just one example of the sort of information that should be included in the NICE Guidelines. (As mentioned by BRAME in their Consultation Document for the last NICE review).

The NICE Guidelines should be informed by the International Consensus Primer for Medical Practitioners and the Scientists and Medical Practitioners in the UK, US, Australia, Norway and other countries, who understand that ME is a biomedical illness and not due to psychological issues.

The premise that ME is a "false illness belief", a result of "de-conditioning", a "fear of exercise" or any of the other ridiculous explanations dreamt up by the BPS proponents, is precisely that - ridiculous. By refusing to listen to patients and by refusing to take seriously the considerable body of biomedical evidence showing that ME is a serious multi-system, physical illness, but instead sticking to the advice of a group of Psychiatrists and their supporters, NICE is making the UK Medical Establishment into a laughing stock amongst serious academics and clinicians. This might be amusing if it were not for the extremely serious consequences for sufferers, their families and carers. The fact that NICE said that they would take into account recent biomedical research, and the fact that CBT and GET are no longer recommended in the US, now seems disingenuous.

The current Guidelines belong to a different era. They MUST be changed."

 

[Deepwater]

I can confirm that Sheffield ME Group (now Sheffield ME and Fibromyalgia Group) emphatically subscribe to the biomedical view of ME. My first contact with the group was in around 2007, when Professor Malcolm Hooper spoke at the group's Annual Conference. I had only just been diagnosed. I eventually went on to become Vice-Chair, and then Chair, when Ute resigned due to ill-health. Sadly, I too had to resign due to family commitments and my own health, but I am still involved with the group on a daily basis as a Volunteer. During my long association with Ute, she never suggested, in my presence, that ME was anything other than a biomedical illness, but was always at pains to point out that the group was "not a campaigning group" in her words. It is true that the Board is now prepared to "nail their colours to the mast" so to speak and they came out, publicly, in support of the OMEGA Petiton. They also asked to be added to the list of signatories on the letter to the editor of the Lancet, but I don't think that actually happened.

Thanks very much for clarifying that, Carol. I'm sorry to hear about your ill health, and Ute's, and so glad that the group has come out in support of OMEGA. Did Ute ever talk to you about her experiences with the NICE panel? Perhaps I shouldn't be asking as I can't ask you to speak on her behalf, but of course we'd all like to have a better understanding of exactly how things ended up the way they did.

 

[CarolB]

You're welcome. Actually, she didn't and it's only recently that I became aware of the significance of her contribution, as I didn't realise that the NICE GDG consisted of so few people. I always assumed that she had been part of a broader consultation, something like the stakeholder's list. I was quite surprised when I saw the list of GDG participants a few days ago. I agree that we'd all like to have a better understanding. The mind does boggle, doesn't it?

 

[CarolB]

I've just tried to post this comment on the MEA Petition, after signing in to Change.org, but it won't let me. It keeps telling me to try again. I signed the petition a couple of days ago, but I thought you could comment retrospectively. Is it because it's too long? Does anyone know?

"I was told that CBT was the treatment for ME/CFS. My life had been taken away by ME. I was desperate. I entered into the therapy with all the enthusiasm that I could muster. The Therapist said that he had never met anyone who had engaged so well with the treatment. It didn't work. I was despondent. I was offered GET, but refused.

The concept of GET seemed wrong-headed and crazy to me from the start. I concentrated on engaging in what little activity I could, when my body told me that it could.

I also suffered from extreme and life-limiting MCS and severe and immediate histamine reactions to half the foods in my (healthy) diet, as well as the neurological symptoms associated with ME.

Ten years on and I am continuing to improve. I can walk 5 miles at a good pace and can eat anything, but I still have mild MCS, which is now an inconvenience to me, rather than an illness.

PWME are not stupid. We don't collapse into our beds, in fear of activity exacerbating our symptoms. We don't get worse by joining Support Groups that legitimise our "illness beliefs". The information that my Support Group provided was instrumental to my recovery, when the NHS could give me none.

Why didn't the Lead GP, at my local CFS Clinic, know that adrenaline in local anaesthetics can make PWME more ill, sometimes pushing them into a relapse, when my local ME Group did, and they provided me with evidence that meant that I could have dental treatment, and eventually an hour long operation for a detached retina (I refused a general anaesthetic or sedation due to my MCS) without being made even more ill in the process? Why did my dentist not know this when she ignored my request for an adrenaline-free anaesthetic and included it without my knowledge? The unfortunate result of this, at least, made her realise that I wasn't making it up and she has now shared the information that I gave to her with our local dental hospital. Why do PWME consistently complain of this, many avoiding dental, or other procedures completely, not knowing that it is the adrenaline in the anaesthetic that is making them ill? This is just one example of the sort of information that should be included in the NICE Guidelines. (As mentioned by BRAME in their Consultation Document for the last NICE review).

The NICE Guidelines should be informed by the International Consensus Primer for Medical Practitioners and the Scientists and Medical Practitioners in the UK, US, Australia, Norway and other countries, who understand that ME is a biomedical illness and not due to psychological issues.

The premise that ME is a "false illness belief", a result of "de-conditioning", a "fear of exercise" or any of the other ridiculous explanations dreamt up by the BPS proponents, is precisely that - ridiculous. By refusing to listen to patients and by refusing to take seriously the considerable body of biomedical evidence showing that ME is a serious multi-system, physical illness, but instead sticking to the advice of a group of Psychiatrists and their supporters, NICE is making the UK Medical Establishment into a laughing stock amongst serious academics and clinicians. This might be amusing if it were not for the extremely serious consequences for sufferers, their families and carers. The fact that NICE said that they would take into account recent biomedical research, and the fact that CBT and GET are no longer recommended in the US, now seems disingenuous.

The current Guidelines belong to a different era. They MUST be changed."

I've just been informed that there's a technical fault.

 

[dangermouse]

@CarolB hope you manage to get your comment onto the petition comments, it's a good one!

 

[CarolB]

Thank you, I did. The glitch seems to have been fixed now. Sadly it's lost in amongst all the other comments so it isn't seen at the top and it's only got about 11 "likes" so far, so won't be noticed.

 

[dangermouse]

@CarolB

 

[RogerBlack]

Is there a formal process for reporting harms caused by the guidelines?

Rather than just informal complaints about them, or requests for alterations.

 

[alex3619]

Is there a formal process for reporting harms caused by the guidelines?

Rather than just informal complaints about them, or requests for alterations.

The public and the medical profession would be well served if there were formal processes to report adverse effects from all treatments, not just drugs. Last time I looked at this some years ago I could only find evidence of such a process for drugs.

 

[Freespirit]

Please share widely
Local groups can register as stakeholder for nice consultation on guideline review, it's easy, fill in form at nice website
be kwik it ends in few days.

Then if reveiwed l8r, can contribute in that consultation.
Cbt/get not effective treatment, may help manage, but may harm
Not for severe me, should be voluntary not forced
No child protection or mental health assessment to persuade compliance

 

[SamanthaJ]

Please share widely
Local groups can register as stakeholder for nice consultation on guideline review, it's easy, fill in form at nice website
be kwik it ends in few days.

Then if reveiwed l8r, can contribute in that consultation.
Cbt/get not effective treatment, may help manage, but may harm
Not for severe me, should be voluntary not forced
No child protection or mental health assessment to persuade compliance

I've heard from a charity that they've been told it takes 28 days to register as a stakeholder? Presumably that's how long it takes NICE to process the application. But it's still worth doing for whatever comes after this.

 

[charles shepherd]

Predictable but disappointing written answer to a House of Lords PQ tabled by the Countess of Mar re membership of the group that has been reviewing the evidence for NICE

NICE are still dealing with an FoI request on the same subject

CS

Subject: Written answer to your QWA HL637 received from Lord O'Shaughnessy, the Department of Health



Lord O'Shaughnessy, the Department of Health, has provided the following answer to your written parliamentary question (HL637):

Question:
Her Majesty's Government who were the experts the National Institute for Health and Clinical Excellence consulted in their recent review of Clinical Guideline CG 53 for chronic fatigue syndrome and myalgic encephalomyelitis: diagnosis and management. (HL637)

Tabled on: 10 July 2017

Answer:
Lord O'Shaughnessy:

The National Institute for Health and Care Excellence (NICE) routinely consults a range of topic experts as part of its surveillance review process. NICE is currently consulting on a review proposal for its clinical guideline on the diagnosis and management of chronic fatigue syndrome and myalgic encephalomyelitis. NICE does not routinely publish the names of topic experts as they are not part of the decision making process for the surveillance review.

Date and time of answer: 19 Jul 2017 at 12:03.

 

[dangermouse]

NICE does not routinely publish the names of topic experts as they are not part of the decision making process for the surveillance review

Why not? What difference would it make for the general public to know who the experts are that (I assume) greatly influence the decision makers?

If there is transparency everyone will be suitably reassured that this influence is impartial and unbiased (won't they??).