Karina Hansen news (updated: her guardian is discharged)* + a battle with NICE (the UK’s National Institute for Health and Care Excellence)

[NOTE: a brief personal update

Last year I went to live abroad. I wrote about this change in my February 2017 post PAUSE-REVIEW-REFLECT: towards a bigger picture? [revised version . As of September 2018, I am now UK-based again. While I was away, I continued my work assisting and advising members of the international myalgic encephalomyelitis (ME) community, in addition to the general research work which I have been doing for many years, some of which is reflected in this blog. My work goes on although it remains severely limited by health problems (I have lived with ME since 1981).]

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* KARINA HANSEN NEWS – updated 10 October

On 26 September 2018, a further court hearing took place in the case of Karina Hansen. Karina is a young Danish woman with severe ME who was forcibly removed from her family home by the state authorities and confined to an institution as a de facto psychiatric patient for three and a half years. She was eventually allowed to return home in October 2016. However, the local court had appointed a guardian in her case, because of misplaced concerns regarding her capacity to make decisions about her own health and finances.

The 26 September hearing was to determine whether or not the guardian should continue in his role or be discharged by the court. As often happens at court, the matter was adjourned until 10 October.

On 10 October, the court finally discharged the guardian from his duties in relation to Karina.

Karina has now finally regained control of her own health and financial affairs

For full details and the background to her story, see my previous post at Karina Hansen 8 (updated): the aftermath continues The full list of articles about Karina can be found in the Karina Hansen category in the sidebar of this blog.

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THE BATTLE WITH NICE

(This is quite long, at slightly over 4500 words, but it falls naturally into shorter subsections so I hope that the brain-fogged among us – of which I am one – will be able to read it in stages. That is how I had to write it).

NICE is the UK body which “provides national guidance and advice to improve health and social care.” It was first created in 1999. NICE issues guidelines on the diagnosis, treatment and management of a range of illnesses. The last set of guidelines for ME (or “Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome” as it is currently calling the condition) was issued in 2007. This was a problematic time for the ME community, not least because of the failure of a judicial review (JR) of the CFS/ME [sic] guidelines review process. The JR was launched by two community activists and concluded unhappily in 2009.

The 2007 guidelines were due for update in 2017 but, initially, that review was postponed. Following pressure from the ME community, this decision was reversed and an update is now ongoing with the new guidelines expected in October 2020.

Some background observations

Earlier this year, I had an email discussion about the NICE process with another member of the ME community. In order to put a context around my subsequent exchanges with NICE (below), I’m copying some extracts from that discussion (my emails only, slightly edited for clarity):

February 2018  (in response to some questions)

The current incarnation of NICE was created by statute, the Health and Social Care Act 2012 (HSCA). It is governed by its own process as set out in the manual. There is very little flexibility about what it can do and how it can do it. NICE is not governed by any one specific area of law but by general public and administrative law practice and procedure, as are all public bodies. Likewise, the status of stakeholder has no legal basis as such. Any attempt to try a novel legal approach [on the process] would be risky in terms of costs and outcome.

Professor Mark Baker [the then outgoing Director of the Centre for Guidelines at NICE] will not be able to make any undertakings or commitments. That would be beyond his discretion and outside the scope of the NICE process. Even if he could, he could not bind any successor. It’s necessary to understand that, even if anyone at NICE did want to “help” the ME community more, they do not (officially) have the power to do so ie. even if they did, they would not be able to say so publicly.

I am the first to argue that ME patients merit special treatment, given the way we have been treated over many decades. However, the NICE process isn’t going to fix that. Without the benefit of a comprehensive, proactive/reactive media strategy aimed at radically changing the perception of both patients and illness (which would take a while) this will be a slow process [emphasis added].

Whether or not it’s worth engaging in the NICE process is an impossible question. I have argued that we needed an expedited review to prevent further harm [by continuing the current treatment recommendations] but the amount it can achieve is limited, as is the role of stakeholders. Trying to get NICE to accommodate the demands of the community won’t work. However, even if a mass walkout of patient groups could be organised, that just leaves the review in the hands of unhelpful others. On balance, I think it’s better to be part of it but to keep expectations realistic.

That said, there is always room for appropriate direct action by patient groups, so that voices are heard and concerns raised. Unfortunately, our reputation precedes us (crazy/hostile/angry/dangerous/unreasonable etc. etc.) and that isn’t a good starting point.

As I said in [a recent] blog post – “The exhortation to “speak truth to power” has become a commonly used slogan. The actual use of this concept to achieve real results is a complicated and nuanced process, especially if those doing the speaking are themselves without power.” Until we can change that [see reference to “media strategy” above], progress will continue to be painfully slow.

And later:

March 2018

The NICE manual on developing guidelines is here https://www.nice.org.uk/process/pmg20/chapter/introduction-and-overview The relevant part of the HSCA on NICE (section 232 onwards) is here https://www.legislation.gov.uk/ukpga/2012/7/part/8 It creates the power for NICE to carry out its statutory functions and sets out the usual duties/standards etc.

NICE has very broad statutory powers and is a self-regulating public body. This means that it would have to act very “irrationally” (in the legal sense) for any of its actions to be susceptible to challenge. This is quite normal for bodies of this nature and is to allow them a broad discretion in which to operate.

In a nutshell, NICE writes its own rules and marks its own homework. That said, I wouldn’t necessarily dismiss everyone connected with it out of hand. Obviously, I remain sceptical – but not everyone is a bad guy. However, as I said before, those who work for NICE have very little discretion in what they can do as they are bound by the process.

The main purpose of section 232 was to bring social care under NICE along with health. Presumably this was for political expediency – more commonly known as other ways in which we can cut costs and screw patients/those needing social care.

[apologies for the language but sometimes it’s necessary to call a spade a spade…]

The battle begins

NICE appears to encourage community engagement by inviting interested organisations to register as stakeholders in the guidelines update process. Because of the particular work which I have done over the many years, I applied to become a stakeholder for the “ME/CFS” review process under the “Organisations that fund or carry out research” category. This was in May 2018. (My application was much later than I had intended as a result of other life events intervening).

My application was duly accepted. In July, I checked the newly-updated list of stakeholders but could not find my organisation, Law and Health (the sub-heading of this blog since 2012) listed. I queried this with NICE and received the somewhat alarming reply below (note that there are some redactions in this correspondence because of data protection requirements). I apologise for the chaotic formatting which, despite my best efforts, falls apart from this point on:

NICE to me – 25 July 2018

We currently have you registered on our stakeholder list under the Queen Mary University of London name. This is because this organisation meets our criteria to be a registered stakeholder as we accept universities as stakeholders on our guidelines.

If you wish to be registered under the Law and Health organisation title instead, we would need you to re-register through our website as a stakeholder under this organisation name. Please be advised however that we would require proof with your registration that this organisation has a national remit and meets our criteria outlined on our website.  

If you are happy to stay registered under the Queen Mary University of London name, we are happy to accept any consultation comments from you and formally respond to each of these comments. However, please be advised that should your Law and Health organisation be judged to not meet our criteria, we will now not be able to formally respond to any comments you submit. We can only respond to comments from registered stakeholders which you currently are.

My reply to NICE – 1 August

I have given some further thought to our recent email exchange and would like to raise the following points:

1. I applied to register as a stakeholder under the banner of my organisation “Law and Health”. The notification that my application had been successful did not explain that this had been changed and I was now registered as a QMUL stakeholder. This was a unilateral change made without consultation or agreement and the notification was therefore misleading.
2. Law and Health is a small organisation but, to the best of my knowledge, no other UK organisation covers this area. Its remit is to research due process as it relates to medical issues, particularly “ME/CFS”. Some of its work is reflected on the website (link below) but there is also ongoing work providing advice and assistance to other groups and individuals. This work is not publicly visible. To continue the work, I need access to as much information as possible regarding governmental, quasi- and non-governmental bodies. This is why I applied to register as a stakeholder under the Law and Health banner.
3. I have no mandate to speak for QMUL regarding the NICE guidelines review. QMUL is aware of my work on “ME/CFS” and I use my academic address because it gives me greater access to research materials. However, I would be unable to comment on behalf of QMUL on NICE issues as my academic status there does not relate to this area. 
4. I realise that the current round of comments on the current review has just closed. However, I would like the option of commenting later on in the process and to continue to receive the relevant documentation as a legitimate stakeholder.

I would be grateful if you would clarify how this situation came about, that I was registered under a different organisation from the one under which I applied and then not told of the change or given the chance to make further representations.

I would not expect to have to submit a further application as my first one should stand on its own merits in conjunction with the additional information I have provided here.

My reply to NICE – 15 August

Thank you for your email. As it mostly repeats the earlier points made by X, it does not take matters any further.

I am completely baffled as to why NICE should be using so much time (and therefore also public funding) trying to prevent me from becoming a legitimate stakeholder in the guidelines review process under the “organisations which fund and carry out research” criteria.

The evidence for this research (which we also fund) is clear and is contained within the Law and Health blog. It is also clear that it is not a “personal” blog, as you state (other than the category marked “Personal” in the sidebar). The title Law and Health appears at the top left of the screen, under the main picture, as it has done since I created the site in 2012.

Law and Health is neither “local” nor “regional”. The fact I provide assistance to other national stakeholder organisations indicates that its work is NOT covered by any other UK organisation.

NICE’s policy in dealing with this stakeholder application is proving to be opaque, inequitable and random in its application of the criteria. The effect of this approach is that I am apparently required to make representations retrospectively and in the absence of formal notice of the reasons for the refusal of the application.

As a statutory body and an executive branch of a governmental department, NICE is required to be fair, transparent and accountable. This stakeholder selection process is failing to meet those standards.

I would be grateful if you would advise me of the appeal process from this point.

My reply to NICE – 17 August 

This is not only about access to information but also proper recognition of a legitimate stakeholder. Your response is based purely on opinion and does not contain any reasoning behind your decision. 

 

The lack of a proper structure in your replies suggests that NICE is making up the rules as it goes along and then marking its own homework after the event. This allows an inappropriate degree of control over the process without any independent scrutiny or review mechanism .

As I said before, NICE is a publicly-funded body, created by statute, and an executive branch of a governmental department. As such, it is required to be fair, transparent and accountable. This stakeholder selection process fails to meet those standards. 

 

You will be aware from reading my blog that I have lived with ME, in varying degrees of severity, for 37 years. As a result, my resources – both in health terms and financially – are limited. I am therefore not in a strong position to pursue this process any further. Ultimately, it concerns a point of principle and the outcome will not change anything for the benefit of the millions of people who live with this illness worldwide. 

 

My main purpose for the years that remain to me is to continue to do as much as I can to improve the shocking conditions with which those with ME have lived for many decades. There would seem to be little to be gained from wasting more time and further exacerbating my health by pursuing this process. However, after due consideration, I have decided to send this email separately to the Associate Director as a formal complaint, not in the expectation of any progress, but because this situation needs to be addressed at the most senior level within the NICE structure. 

My reply to NICE – 22 August

My complaint is that NICE is not operating in a fair and transparent manner in relation to applications to become a stakeholder in the ME/CFS guidelines in development process.

• The original application online submission form is very short and, unless a screenshot is taken, no record of it remains with the applicant
• As I recall, no proof of the organisation’s activities is required at the time of application
• After submission of the application, NICE then apparently conducts its own investigation of the organisation without transparency or accountability in its methodology and in the absence of formal criteria. The investigation procedure is not made clear as a part of the process
• In my case, NICE assigned me as a stakeholder to a different organisation (QMUL) without consultation or notification. I discovered this purely by chance after the event
• The appeal/complaints procedure is unclear and appears unstructuredI am surprised, therefore, to be asked at this very late stage to justify Law and Health’s application to meet NICE’s requirements to become a stakeholder and without knowing what those requirements are. The blog on the website (link at the foot of this email) contains the information which supports my application as an organisation that funds OR carries out research. [continues…..]

NICE to me – 31 August 

Thank you for responding with the further information below, which I have used to inform my review of your complaint about NICE’s decision not to register Law and Health as a stakeholder for the NICE guideline on ME/CFS. I have also reviewed your email exchanges with NICE’s Centre for Guidelines, the information on https://valerieeliotsmith.com/, and discussed your complaint with management in NICE’s Centre for Guidelines.I have undertaken my review in accordance with NICE’s published complaints policy and procedure, having had no prior involvement in this matter.

Firstly, thank you for your interest in engaging with the development of this guideline and I am sorry that you have found the experience unsatisfactory.