NICE statement on the outcome of the Judicial Review

March 13, 2009

The High Court has today ruled in favour of NICE on all grounds brought against the Institute in the judicial review of its clinical guideline on chronic fatigue syndrome / Myalgic encephalomyelitis (CFS/ME). The claim against NICE was brought by two CFS/ME patients. The grounds of challenge, all of which the Judge has dismissed, included an allegation of bias against the guideline development group and its members, that the guideline is irrational compared to the evidence, and claims about the classification of the condition and treatments recommended.

Professor Peter Littlejohns, NICE Clinical and Public Health Director, responded to the High Court judgement saying:

"We are pleased to have won convincingly on all counts in this case – this judgment is a welcome endorsement of the rigorous methods we use to produce our guidelines. This result is very good news for the thousands of people with CFS/ME, who can continue to benefit from evidence-based diagnosis, management and care for this disabling condition.

"The 2007 guideline was welcomed by patient groups as an important opportunity to change the previous situation for the better, helping ensure that everyone with CFS/ME has access to care appropriate for the individual. Today's decision means that the NICE guideline is the gold standard for best practice in managing CFS/ME."

Professor Littlejohns continued:

"The guideline was developed by an independent group comprising clinical specialists in CFS/ME, patient representatives and experts involved in the diagnosis of the condition and provision of care.

"This guideline development group (GDG) considered a range of complex issues in great depth taking full account of the views of patient groups and health professionals. We agree with the judge that the GDG were a dedicated group of individuals who worked together to produce the best possible guideline, and that the accusations that they were biased were completely unfounded.

"The judge recognised the key role that professionals and patients have in contributing to the development of NICE guidelines and therefore understood the vigorous approach NICE took in defending these health experts. We are pleased that all members of the GDG and those involved in selecting the GDG were totally exonerated from the unfounded claims made against them.

"The judgment acknowledges the robust procedures that NICE follows in ensuring that its guidance is independent, evidence-based and fit for purpose. We're delighted that this issue is now closed and look forward to continuing to produce world-class guidance which benefits everyone who uses the NHS."


For more information call Dr Tonya Gillis at the NICE press office on 0845  003 7782.

Notes to Editors

About the NICE guidance

1. The NICE guideline on the diagnosis and management of chronic fatigue  syndrome / Myalgic encephalomyelitis (or encephalopathy)was published in  August 2007:

2. CFS/ME is a relatively common illness, affecting up to an estimated  193,000 people. The condition can be disabling, involving a complex range of  symptoms, the most common being fatigue, but including headaches, sleep

disturbance and muscle pain.

About NICE

3. The National Institute for Health and Clinical Excellence (NICE) is the  independent organisation responsible for providing national guidance on the  promotion of good health and the prevention and treatment of ill health.

4. NICE produces guidance in three areas of health:

. public health – guidance on the promotion of good health and the  prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector

. health technologies – guidance on the use of new and existing medicines,  treatments and procedures within the NHS

. clinical practice – guidance on the appropriate treatment and care of  people with specific diseases and conditions within the NHS.

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