1.0 EXECUTIVE SUMMARY
1.1 My complaint is about NICE’S refusal to do an unscheduled update of their Head Injury Guideline (CG56) to include information about the high risk of pituitary dysfunction after traumatic brain injury – a treatable condition. In particular I asked that the standard letter of discharge, which hospitals use as a template, should contain a warning to patients as symptoms may not occur until many years later. My complaint has two parts: the effect upon others of their refusal and their treatment of me.
In addition, I wish to complain of their decision not to include this information even in their scheduled update, due this autumn.
1.2 The effect of their refusal
1.2.1 Pituitary damage following brain injury can manifest itself through sexual dysfunction. Where brain injury has occurred to pre-adolescent children, this dysfunction will not be evident till puberty when neither parents, patients nor GPs are aware that it is a possible consequence, and the chances of an individual being correctly diagnosed and treated are diminished. This is not a minor problem. NICE themselves have cited research to me indicating that pituitary damage occurs in 20% of head injury patients. [Bundle B: 24].
1.2.2 By in effect refusing to warn patients of the risk they face, NICE have breached the principle of patient autonomy. People cannot make decisions about treatment if they are deprived of information. Since symptoms may appear many years later, people cannot make a connection with the injury unless they are warned. Moreover, NICE have violated natural justice by perpetuating unawareness among professionals which makes it difficult for head injury patients to receive diagnosis for pituitary problems. If patients are not diagnosed, they have no chance of receiving, or fighting for, treatment and are thus not being given fair access to NHS resources.
1.3 Their treatment of me
1.3.1 In my view NICE have not acted with openness or transparency, and they have not followed their own policy and procedural guidance, as I hope to demonstrate below. Their correspondence with me is characterised by tardiness in responding, misleading claims, self-contradiction, failure to honour earlier promises and a bending of their own rules.
1.4 This is not a clinical issue
1.4.1 I would like to stress that there is no disagreement between NICE and myself about the medical facts. NICE abandoned an early attempt to persuade me that the incidence of post-traumatic hypopituitarism was far lower than the generally accepted figure, and they have never tried to minimize the seriousness of its effects.
1.4.2 I enclose a bundle of documents, numbered and listed. I also, on the advice of a medico-legal friend, attach a document in which I list the changes I would like to see made to the guideline. (Bundle A: 11)
2.0 FULLER ACCOUNT
2.1 Pituitary damage after traumatic brain injury
2.1.1 I will begin with a short account of post-traumatic hypopituitarism (PTHP). The pea-sized pituitary gland is the ‘master gland’ that controls among other things growth, sexual function and response to stress. Many studies have indicated that between 20% and 30% of head injury patients suffer damage to this gland. The immediate effects can be life-threatening and the long term effects can include loss of libido, impotence in men, loss of periods in women, infertility, depression, uncontrollable weight gain, fatigue, loss of temperature control, and diabetes insipidus. A systematic review [Bundle A: studies (1)] covering more than 1,000 patients found that 27.5% of traumatic brain injury patients, and 47% of patients with subarachnoid haemorrhage, sustain damage to the pituitary, and that this can occur after mild as well as severe head injury. The symptoms may appear immediately but also decades later.
2.1.2 A recent study has this to say:
Given the large number of individuals who fall victim to TBI and SAH each year, post-traumatic hypopituitarism becomes an entity of major public health significance. Based on the incidence of patients hospitalized for TBI and SAH reported in the literature and the frequencies of hypopituitarism in these patients, the incidence of hypopituitarism caused by these disorders is estimated to be more than 30 per 100,000 per year. [A: studies (2)]
It is therefore a problem affecting thousands of people, with considerable financial implications for the NHS.
2.2 NICE scope and audit criteria
2.2.1 It will become apparent that there was disagreement between NICE and myself about the scope for their head injury guidance. I would therefore like as a first step to point out that NICE have devised 10 audit criteria for this guideline, two of which are concerned with what happens in the long term. These are
Criterion 9, “Percentage of patients, and their carers, made aware of the possibility of long-term symptoms and disabilities following head injury” with the definition “details should be included on patient discharge advice cards”
Criterion 10, “Percentage of patients, and their carers, made aware of the existence of services that they could contact should they experience long-term problems following head injury” with the definition “Details of support services should be included on patient discharge advice cards.”
2.3 My correspondence with NICE – Phase One (November 2008 to July 2009)
See correspondence with NICE NICE Correspondence
2.3.1 Our son committed suicide in August 2008. He was thirty-one when he died, and we discovered posthumously that he had been impotent. It was only after studying some of the research on head injury that we put two and two together and realised that his sexual difficulties could have been caused by pituitary damage sustained in a serious head injury in 1984 when he was seven. We realised that there must be other head injury survivors in a similar situation and were amazed to find that NICE Head Injury Guideline CG56, dated 2007, made no mention of the problem, even though a large body of research had built up since the 1980s, and especially from 2000 onwards. We were similarly amazed that our request for such an obvious and simple change should meet with obstruction.
2.3.2 I wrote to NICE several times from November 2008 [B: 1, 4, 6, 7, 9, 11, 12, 13] asking that they update the guideline. In April 2009 [B: 15] I pointed out that when a guideline has an error ‘which may result in harm to patients’ they have a duty to update immediately (NICE Guidelines Manual 14.6, A: 9). After a silence of two months which was broken only when I sent a reminder [B: 16], I received a reply from Dr Macbeth (Director Centre for Clinical Practice Director) which said [B: 17, see App 2]:
Through the President of the Royal College of Physicians, I sought the opinion of a senior endocrinologist in the UK. Interestingly he has just completed a study similar to the ones from Italy and Dublin testing patients being followed up following head injury. His study which has not yet been published but will be submitted in a few months shows a very much lower incidence than previously seen. Although I am not denying the seriousness of this condition and the scope for a disastrous outcome if not recognised, this information together with the previous opinion of the chairman of the guideline group, leads us to conclude that an immediate update is not justified. . . However when the guideline is updated we will ensure that this issue is addressed.’
2.3.3 It seemed strange – and not consistent with NICE procedure as described in Social Value Judgements [p 13] [A: 10] – that instead of basing his decision on the consensus of published research, Dr Macbeth should rely on the findings of a single unpublished study. What was to prevent this study being untypical? And in any case, how could a single study, (unless unimaginably large) overturn the conclusions of so much previous research? I asked for details about the study but received the reply, “Unfortunately we are not at liberty to release the name of the author of the as yet unpublished research . . nor are we able to comment on the precise incidence of the condition in the report.” [B: 17a]
2.3.4 They have still not produced this paper for me, nor have I seen one corresponding to this description.
2.3.5 However I was able to obtain a statement [B: 6] from the distinguished endocrinologist Professor Chris Thompson in Dublin that “The vast majority of the published papers suggest figures of 20% to 30% for PTHP after traumatic brain injury” and that a lower figure was “incorrect.” When I reported this to NICE [B: 21] they made no attempt to argue the point. Instead, they changed tack.
2.4 My correspondence with NICE – Phase Two (July to August 2009)
2.4.1 In July 2009 I put in a Freedom of Information request [B: 18] for all documents generated by my April letter. I asked, among other things, on what grounds NICE could justify not updating immediately the sample letter of discharge so that it warned patients that hypopituitarism might affect them after an interval of time. I said, quoting from ‘Principles of Bioethics’ in NICE’s Social Value Judgements (respect for autonomy) [A: 10], that if individuals have a right ‘to make informed choices about healthcare . . and health protection’ it was crucial that they should be given information about the risks they faced.
2.4.2 I also made the points that
the incidence was not diminished by the new research
there was a duty under 14.6 of the NICE Guidelines Manual [A: 9] to correct an error which might cause harm to patients and which severely compromised NICE’s Quality Assurance Procedures (two criteria defining an error)
2.4.3 NICE’s reply in August [B: 22] was silent about the incidence and the unpublished research. On the subject of the discharge letter the reply was “It is not appropriate for us to update this document to warn about the possible danger of hypopituitarism as this does not reflect the original guideline scope.” They claimed that the scope of CG56 only consisted of 8 key clinical questions about how to get the patient to expert care in a timely manner, which they listed, adding “The scoping search did not focus on identifying studies relating to hypopituitarism as this did not address the review questions above.” Therefore there was no error and they had no duty to update.
2.4.2 This sudden volte-face about the scope was surprising. It had not been mentioned before and seemed very artificial. In fact Dr Macbeth’s earlier promise to address the issue when the time came for the scheduled update had been a tacit admission that it belonged there.
2.5 My correspondence with NICE – Phase 3 (September to November 2009)
2.5.1 In September I moved to the next stage of appeal, writing to Ms Alana Christopher, [B: 23]. My main points were that NICE had not taken into account the relevant research and were under a misapprehension about the number of people at risk, and also that they had misinterpreted the scope. I pointed out that section 1.17 of their 2007 guideline [A:1], having stated, as NICE said, that “only eight clinical questions . . . are covered within this partial update” continued crucially that “all other criteria set in the scope (Appendix A) are covered.” (The scope in Appendix A was of course the 2003 scope, which expressly said that the guideline would provide criteria for the early identification of patients who would benefit from rehabilitation.) [A:4]
2.5.2 Ms Christopher’s reply [B: 24] conceded that a recent study reported that 20% of 246 patients had biochemically identifiable pituitary dysfunction. With regard to the scope, she argued that a sentence I had quoted (that “persistent disability or even death result from the effects of complications, which can potentially be minimised or avoided with early detection and appropriate treatment”) came from CG56’s introduction and not the main definition, the implication being that it didn’t count. She said that the scope was defined in the Population, Healthcare Setting, and Interventions and Treatment sections. She concluded “In our view [the scope] does not include the identification and management of the late complications of head injury such as pituitary failure.” She said that NICE were proposing to prepare a separate guideline on the topic.
2.5.3 To this I replied on 23 October 2009 [B: 25] that the scope specifically stated
The guideline will provide criteria for the early identification of patients who would benefit from rehabilitation
The guideline will include . . secondary care with the aim of early detection of intracranial complications . . the aim is . . to arrange for appropriate diagnostic procedures and treatment.
(These two points came respectively from the ‘Population’ and ‘Interventions and Treatment’ sections.)
2.5.4 I said that I was puzzled by her silence about these parts of the scope. “I cannot think you wish to imply that the pituitary is not situated in the cranium and that damage to it is not a ‘complication,’ or that hormone replacement does not form a part of the patient’s rehabilitation, the process whereby he/she is helped to live a normal life again.”
2.5.5 NICE’s statement that the scope was limited to the 8 questions was misleading. It is hard to believe they had read the first part of the sentence they quoted to me, without also reading the second. Their offer to prepare a separate guideline was unsatisfactory because it was effectively a means of ‘hiving off’ the issue into a document that might or might not be consulted by most hospitals, while leaving the all-important discharge advice unchanged.
2.6 Final phase
2.6.1 On 30 October 2009 I redirected this reply to Andrew Dillon, the Chief Executive Officer [B: 26]. The points in his reply [B: 27] can be summarized as follows:
“However broadly the scope . . . could be interpreted (a concession to my arguments), “it was not intended to identify and cover all the potential complications of head injury.” He claims it was reasonable for NICE to identify the limits of what they considered ‘early management’ and hence that the exclusion of the identification and management of pituitary failure was consistent with the DoH’s intention.
He concedes that hypopituitarism occurs but does not consider there is ‘sufficient risk of serious harm’ to warrant an immediate update. Nobody in the NHS has said there is a crisis.
To refer the topic for selection as a clinical guideline was appropriate, given the need “to balance our guideline capacity across all the demands by the NHS.”
He claims the discharge letter, which warns that some people only develop problems after some weeks or months, and advises contacting their doctor if they feel “things are not quite right” is adequate. More information might alarm the patient.
2.6.2 I have to confess that I lost heart at this point. I did not reply as I could have, teasing apart the phrase ‘identification and management’, and pointing out that while the management of complications is excluded from the scope, their identification is most certainly not. However on 7 January 2010 I sent a brief reply [B: 28] saying “Your refusal is predicated on the assumption that post-traumatic hypopituitarism is a ‘late complication’. It is not a late complication. It is an early one.” I cited research establishing that the highest incidence comes at the acute stage, when deficiency of TSH, ACTH and ADH has all been associated with high mortality. I summed up that both the 2003 and the 2007 guidelines omitted to mention a common, life-threatening complication included in the narrowest definition of the scope. “This is an error which puts patients at risk and by your own rules you are obliged to correct it immediately.”
2.6.3 On 11 January [B: 29] Andrew Dillon replied, conceding that ACTH deficiency occurs in 12% of cases ‘which if severe can be life-threatening.’ He then cited the two of the extremely few papers that question the generally accepted incidence of 20-30% (see below) and ended by reiterating his refusal.
2.6.4 Here I would like to make the following points:
On the discharge letter Andrew Dillon’s claim [B: 26] that a warning that you should go back to your doctor ‘if things don’t seem right’ was proportionate to the likelihood of complications, was misleading. The discharge letter warns of the likelihood of seizures and even of cerebrospinal fluid leakage. These two risks are estimated at 17% and 2-6% respectively, so why should there be silence on a 20-30% risk? The letter’s few vague words in no way prepares a person for a condition that could devastate their sexuality and – even more insidiously – may appear after years of otherwise normal function. How can people make the connection if they are not warned? As for alarming people . . speaking personally, we would infinitely rather have been alarmed than lose our son.
It is hard to understand why preparing a separate guideline would require fewer resources than updating an existing one.
With any studies of relatively small groups of patients there will always be ‘outliers’, because the incidence of a condition is not evenly spread across the population. In his final email Andrew Dillon chose the only published study I know of that finds a low incidence (van der Eerden’s, [A: studies (4)]) and ignored the many, many studies that show otherwise. His reference to Kokshoorn’s article is valid, but Kokshoorn’s strictures about the tests used have already been taken on board, and recent studies such as Professor Thompson’s and Professor Berg’s (the author of the study mentioned by Ms Christopher) use the more rigorous tests and still come out with an incidence of 20% plus.
I have saved to the end what I consider the most extraordinary anomaly of all – the fact that Andrew Dillon can in one breath admit that more than a tenth of head injury patients suffer a life-threatening deficiency of ACTH (caused by pituitary damage) during the acute stage, and in the next insist that this information falls outside the remit of a guideline devoted to the acute stage!
2.7 My conclusion
2.7.2 This appeal to you is prompted by my recent realisation that NICE are reneging on their promise contained in Dr Macbeth’s letter of June 2009 to include the information in their scheduled update of CG56, which is now due. They are using their arguments about the scope to exclude PTHP and claiming that a separate guideline is sufficient. And it is not at all certain that the separate guideline will even go ahead.
2.7.3 I would summarize my arguments as follows:
I feel positively insulted by the following which imply I am a nuisance:
“Joanna is now trying every which way to ask us to update this guideline earlier than the scheduled update.” [B: 22b, Doc 20]
In the third paragraph of his email of 30 November 2009 Andrew Dillon made the offensive insinuation that my freedom of information request had been a kind of stalking horse, under cover of which I had pursued my aim of getting the guideline updated. ‘Although we were happy to respond under our FOI procedure, it was quickly obvious that your real aim has been to persuade us to review our clinical guideline . . [B: 27]. Of course it will be clear from this account that I had entered into correspondence openly on that topic months before my FOI request, and even had a personal reply from him on the topic. [B: 15] There has been nothing underhand in my dealings with NICE.