R (Fraser and Short) v Naitional Institute for Health and Clinical Excellence
| Jurisdiction | England & Wales |
| Judge | Mr Justice Simon |
| Judgment Date | 13 March 2009 |
| Neutral Citation | [2009] EWHC 452 (Admin) |
| Court | Queen's Bench Division (Administrative Court) |
| Date | 13 March 2009 |
| Docket Number | Case No: CO/10408/2007 and CO/10435/2007 |
[2009] EWHC 452 (Admin)
IN THE HIGH COURT OF JUSTICE
ADMINISTRATIVE COURT
Mr Justice Simon
Case No: CO/10408/2007 and CO/10435/2007
Mr Jeremy Hyam (instructed by Leigh Day & Co) for the Claimants
Mr Charles Béar QC and Mr Tony Child (instructed by Beachcroft LLP) for the Defendant
Mr Conrad Hallin (instructed by the Bar Pro Bono Unit) for the Interested Party
Hearing dates: 11 and 12 February 2009
Mr Justice Simon:
Introduction
On 22 August 2007 the National Institute for Health and Clinical Excellence ('NICE') published Clinical Guideline 53 ('the Guideline'). This was a national guideline on patient care for those suffering from Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME); and was published in a number of versions, including the full version (317 pages) and a 'Quick Reference Guide' (23 pages).
The clinical need for the Guideline was explained in §1.2 of the full version.
CFS/ME comprises a range of symptoms that include fatigue, malaise, headaches, sleep disturbances, difficulties with concentration and muscle pain. A person's symptoms may fluctuate in intensity and severity, and there is also a great variability in the symptoms different people experience. CFS/ME is characterised by debilitating fatigue that is unlike everyday fatigue and can be triggered by minimal activity. This raises especially complex issues in adults and children with severe CFS/ME.
CFS/ME, like other chronic conditions for which the causes and disease processes are not yet fully understood, poses significant problems for healthcare professionals. It can cause profound, prolonged illness and disability, which has a substantial impact on people with CFS/ME and their carers. Uncertainties about diagnosis and management, and lack of clinical guidance for healthcare professionals have exacerbated this impact.
The preface to the full version sought to explain the reason for the difficulties in treatment of those with CFS/ME.
In the past their needs have to often been overlooked and this situation needs to change.
Several factors have contributed to the neglect of CFS/ME. Firstly, the illness is poorly understood. There is no generally accepted theory about its cause or causes, and the symptoms can be diverse, with wide variations both between individuals and in each person over time. This creates further difficulties when attempting to define CFS/ME for the purpose of making a diagnosis. Secondly, there is only limited epidemiological evidence on the numbers of people who develop CFS/ME and on the natural history of the illness. As a result, the available therapies are few, evidence of effectiveness is limited to people with mild or moderate CFS/ME, and access to expert therapists had often been difficult.
The Guideline considered and rejected a number of treatments (specified drugs, vitamin supplements and complementary therapies) on the basis that there was not enough evidence that they were effective; and recommended a range of approaches to treatment including offering Cognitive Behavioural Therapy (CBT) and/or Graded Exercise Therapy (GET) to those with mild or moderate CFS/ME on the basis that these were interventions for which there was the clearest research evidence of benefit.
The Quick Reference Guide described CBT and GET.
[CBT] An evidence-based psychological therapy that is a collaborative treatment approach. When it is used for CFS/ME, the aim of CBT is to reduce levels of symptoms, disability and distress associated with the condition. The use of CBT does not assume or imply that the symptoms are psychological or 'made up'. A course of CBT is usually 12–16 sessions.
[GET] An evidence-based approach to improving a person's CFS/ME symptoms and functioning, aiming towards recovery. The first step is to set a sustainable baseline of physical activity, then the duration of the activity is gradually increased in a planned way that is tailored to the person. This is followed by an increase in intensity, when the person is able.
There was a significant body of opinion which disagreed with this recommendation of CBT and/or GET, particularly among members of CFS/ME patient groups. Part of the complaint was directed to what was perceived to be an over-emphasis on a 'psycho-social approach' as to the nature, cause and treatment of the condition, to the prejudice of a 'bio-medical approach'.
The 'psycho-social approach' describes the view that CFS/ME is a somatisation (psychiatric) disorder, which needs to be recognised and treated as such. In contrast, the 'biomedical approach' describes a view that CFS/ME is an organic, neurological disease, whose pathogenesis (disease process) and aetiology (cause) may be unclear, but which produces identifiable physical symptoms of fatigue and neurological disturbance.
There is disagreement as to whether categorisation into these two approaches can properly describe subtle gradations of scientific opinion, which will (or at least should) respond to research and advances in knowledge about a condition whose aetiology is still not understood.
The World Health Organisation (WHO) includes ME as a physical/organic neurological disorder in section G93.3 of the tenth edition of the International Classification of Diseases (ICD.10), and gives an alternative name, Post Viral Fatigue Syndrome (PVFD). However, in this field even the use of some of the terms in common currency may be controversial. In 1988 the US Centres of for Disease Control introduced the term, Chronic Fatigue Syndrome. However, a witness statement deployed by the Claimants from Jane Colby (Executive Director of the Young ME Sufferers Trust) plainly draws a distinction between ME and, what she describes as, 'the artificial construct called Chronic Fatigue Syndrome.'
The Claimants
The First Claimant, Douglas Fraser, was formerly a professional violinist who was diagnosed as 'post-viral' in March 1994 following what was thought to be a viral infection. In 1997 he was diagnosed as having ME. Like many others with ME/CFS both his ability to work and his social life have been severely affected.
The Second Claimant, Kevin Short, is now in his late forties and developed the physical signs of CFS/ME in his twenties. A formal diagnosis was made in 1992. He is concerned that, as a consequence of the Guideline, the only treatments to which he will be entitled will be CBT and GET.
Underlying the present claim are two concerns. The first, which is expressed by the Claimants, is that CBT and GET are treatments that they neither want nor need, and which may be detrimental to their health. In recommending these treatments the Guideline has the practical effect of preventing them obtaining what they consider may be more effective treatment, since it would only be in exceptional circumstances that a Primary Care Trust would fund a treatment which was not recommended by the Guideline. The second is an implicit concern that they may be regarded by health professionals and the wider public as suffering from a mental health condition. Pauline Sykes, whose witness statement is also deployed in support of the Claim, expresses the point in §14.
ME/CFS is a deeply misunderstood (and controversial) condition and as such medical practitioners who are not experts in the condition are naturally unwilling to step out of line with the Guideline. The damage done by the Guideline to ME/CFS sufferers is inestimable as it had firmly bracketed the condition in the minds of the medical profession, whether intentionally or not, as a mental health condition.
NICE
NICE is an independent body responsible for providing national guidance on the promotion of good health, and the prevention and treatment of ill health. As part of its functions NICE provides guidance and guidelines. NICE guidance assesses whether particular drugs or specific treatments are sufficiently cost effective to be recommended for use in the National Health Service. NICE guidelines are broader in their extent and relate to particular illnesses.
It is common ground that while NICE Guidelines help health professionals in their work, they do not replace their knowledge and skills, or override their clinical judgment. Nor do they detract from the right of a patient to be involved in his or her particular treatment. Decisions as to the implementation and monitoring of the NICE recommendations are for NHS Trusts and the Healthcare Commission respectively.
Since it is not possible for NICE to employ experts in every field of healthcare, it contracts with National Collaboration Centres ('NCCs') to assist in the development of guidelines.
Chronology
The origin of the Guideline was a request from the Secretary of State for Health and the Welsh Assembly to NICE in February 2004:
To prepare for the NHS in England and Wales, guidance on the assessment, diagnosis, management of adjustment and coping, symptom management, and the use of rehabilitation strategies geared towards optimising functioning and achieving greater independence for adults and children with CFS/ME.
There was no requirement to investigate the cause of CFS/ME.
On 1 March 2004 NICE commissioned the National Collaboration Centre for Primary Care ('the NCC-PC') to draw up the Guideline. The NCC-PC in turn entrusted this task to a Guideline Development Group ('the GDG').
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