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EMBARGOED UNTIL 00.01HRS GMT THURSDAY 04 OCTOBER 2007

NICE must loosen up

NICE (The National Institute for Clinical Excellence) guidelines are too rigid and often say ‘yes’ or no’ when ‘yes, if’ would be most appropriate to ensure that patients are offered properly evaluated treatments.

A number of papers in this month’s issue of the Journal of the Royal Society of Medicine, while supporting NICE’s mission on behalf of the public, suggest that there are serious flaws in the way the guidelines are both devised and interpreted.

Sir Iain Chalmers, a member of the NICE Research and Development Advisory Committee, argues that NICE needs to use its OIR – Only In Research – option more frequently. “This strategy could help to protect patients and the NHS itself from inadequately assessed treatments, particularly at a time when NICE has been required by politicians to introduce a ‘fast-track’ single technology appraisal for new drugs.”

The OIR proviso is a “third way” option which allows that, where there is uncertainty about a drug or a technology, NICE is able to issue guidance for it to be used only within the context of research until more is known about its effects. Sir Iain argues that the recent legal challenge to NICE’s guidance on the relative value to the NHS of drugs for early dementia might have been avoided – and more relevant evidence obtained – if NICE had advised that the drugs should only be used in the context of further evidence.

“Rather than having to defend itself in court, how much better it would have been if these public funds had been used to address uncertainties about which patients are likely to benefit from these drugs and which can expect only to suffer their adverse effects…”

A paper by Chalkidou, Hoy and Littlejohns appears to endorse Sir Iain’s recommendation, in their review of instances where NICE has used the OIR proviso in the past. They conclude that OIR recommendations “represent the only rational way for addressing uncertainty, consistent with NICE’s principles of transparency and methodological robustness.”

In another editorial, authors Gupta and Warner, are more critical of NICE guidance, specifically in the area of psychiatry. They argue that this branch of medicine is one where “a degree of flexibility and creativity play an integral part.” Their paper questions the quality of evidence used to make recommendations, the constitution of the panels making decisions for NICE, and the fact that the Institute appears to find it difficult to “keep pace” with evolving treatments.

While acknowledging that guidance is extremely useful, they perceive a recent trend toward guidelines being enforced “quite rigidly and in a way that may limit individualised care of patients….” This, says Susham Gupta, means that there is a risk that “both clinicians and patients will lose confidence in the whole NICE process.” They give examples of where they believe NICE guidance has been poorly formulated.

Finally, authors Chidgey and Leng look at the way in which NICE guidance has been implemented and how it is quite clearly changing clinical practice.

Dr Kamran Abbasi, editor of the JRSM, comments “The central problem for NICE is that too many clinicians view its rationing role with displeasure, and each decision and guidance brings its own enemies…It is hard to argue with iron rules of economics but the problem for NICE, as with many national organisations, is that clinicians feel increasingly isolated from the decision –making process and increasingly resentful of the inflexibility of high-level commandments.”

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The above articles are published in the October issue (Vol.100) of the Journal of the Royal Society of Medicine and are available free.

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