National Institute for Clinical Excellence and its value judgmentsBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7459.224 (Published 22 July 2004) Cite this as: BMJ 2004;329:224
All rapid responses
Rawlins and Culyer have bravely set out the moral wares of the
National Institute of Clinical Excellence (NICE)1. They do this within a
culture whose language of morality is considered by the moral philosopher,
Alasdair MacIntyre, to be in a state of ‘grave disorder’2. Predictably,
NICE’s attempt to ‘embody values that are generally held by the population
that the NHS serves’ has produced a utilitarian and economic formula
epitomized by the Quality Adjusted Life Year (QALY), a notion that only a
market-dominated culture could possibly produce. So do NICE’s value
judgements and systems actually generate any useful advice to
professionals on ‘providing NHS patients with the highest attainable
standards of care’? Sometimes quite the opposite.
In our view, the main barrier to a high standard of care is not a
shortage of technologies or biomedical guidelines, but a narrowness of
perspective. High quality care depends on an understanding of human
suffering that transcends our urge to fix biological machine faults. In
fact, from the general practice viewpoint, NICE’s technology appraisals
are often most useful when they help us block the availability of a new,
expensive and marginally effective technology. Then it is easier to
converse with a patient about coming to terms with adversity or changing
behaviour. But in the approval of some of these technologies the weakness
of NICE’s values shows up.
Take obesity. In March and October 2001 NICE approved the
prescription of Orlistat and Sibutramine for the treatment of obesity.
Meanwhile, the developed world faces a pandemic of obesity for which
NICE’s contribution becomes a diversion, a side show. Obesity is about
consumption, and consumption is woven into the fabric of our society. No
amount of medicine stands any meaningful chance of changing this. The
problem is cultural and the preferred solutions are political and
We might be spared these distractions if NICE would add these two new
questions to the appraisal process:
1. Is the problem for which the technology is intended best dealt with by
a medical approach delivered by the NHS?
2. Would receiving the technology be likely to benefit the health (broadly
defined) of the individual patient?
Addressing these questions requires a clear understanding of the purpose
of the NHS (something that is hardly clear at present), and a notion of
health that transcends patients’ fantasies about magical medical
solutions. In this difficult area we need values that are based on more
than economic utilitarianism and that recognise how disease entails a more
complex world of relationships: with ourselves, with society and with
Nature. There may then be some hope of protecting patients and the NHS
from the medicalisation of societal and cultural problems: a trend that
threatens to overwhelm health care systems. Finding answers will be
difficult for the very reasons that MacIntyre enunciates, but we must try,
or accept that medicine will choke on its own trivial non-solutions for
1. Rawlins MD, Culyer AJ, National Institute for Clinical Excellence
and its value judgments, BMJ 329: 224-7
2. MacIntyre A, After Virtue London, Duckworth 1985
Competing interests: No competing interests
Rawlins and Culyer (Ref1) accept that one of the reasons for the
creation of NICE was to deal with inequalities in access to health care.
Even before we consider the argument so well presented by Maynard and
colleagues (Ref 2), that by denying its role as a rationing body, NICE has
no real hope of achieving equity , we need to examine the role that NICE
actually plays in dealing with so called postcode rationing.
The attack on postcode rationing is led by politicians. As such the
focus is very much on access to the latest cancer drugs and refined
arguments about clinical effectiveness and cost per QUALY have little
place in the debate. The Government requires NHS organisations by law to
fund NICE approved treatments within three months of a favourable
Local considerations, including clinicians’ experience with the new
technology and the availability of ancillary services that may often be
necessary to introduce the new treatment are no longer valid reasons for
the health service to take a planned and considered approach. Sales data
from drug manufacturers are used to monitor the uptake of NICE guidance.
Where once drug firms sought marketing authorisation from the drug
regulatory body, now an even bigger prize is NICE approval. After all, who
needs a marketing license when you can get a compulsory purchase order.
As a result local clinical, public health and even health care
priorities are skewed. There is little recognition of the fact that new
technologies necessarily diffuse out over a period of time and at a
varying rate across the country.
In terms of health (as opposed to health care) the agenda is
therefore set not by NICE but by those who apply to NICE for their
products to be appraised. Why has not NICE conducted an appraisal (despite
ample Grade 1 evidence) of yoga or transcendental meditation as a
treatment for stress and for hypertension? Or a lifestyle intervention
involving 3-4 Kg weight loss and 150 mins of moderately vigorous physical
activity a week as a ‘technology’ that cuts the risk of overt diabetes by
50%?. Simply because these are not pharmacological interventions with a
sponsor with deep pockets and extensive lobbying power.
The postcode rationing that applies to a few new and expensive cancer
drugs pales into insignificance when compared to the real postcode lottery
of life. It applies far more both to health care (access to quality
primary care for example) and to the determinants of health care (housing,
education, job opportunities, healthy food, for example). The mandatory
requirement to implement NICE guidance on drug treatments that have been
submitted to it for appraisal, means that we in the NHS have less time
and no resource to devote to other public health interventions that may
well yield a far bigger health dividend for a larger number of people.
1. Rawlins MD, Culyer AJ. National Institute for Clinical Excellence and
its value judgements. BMJ 2004; 329:224-227
2. Maynard A, Bloor K, Freemantle NK. Challenges for the National
Institute for Clinical Excellence. BMJ 2004; 329:227-229
Competing interests: No competing interests
The National Institute for Clinical Excellence aims for the 'highest
attainable standards of care' . The bedrock of its advice is published
evidence of Benefits from treatment (mainly pharmaceuticals). Careful
reading of the Report accepted on 19 May 2004  reveals that
consideration of Safety issues is focused on invasive surgical/diagostic
procedures and that 'judgement' on Risk assumes that such risks are small
and calculable. In economic terms, it is important to distinguish between
real Risk (calculable and potentially manageable) and Uncertainty, where
judgement of costs is purely subjective.
On 13 July 2004, the new Health Service Director of Research and
Development announced a forthcoming national programme of research on
medication in children. Given the serious and quite common adverse
consequences of paediatric treatment that are reported  a fundamental
re-assessment of child health interventions seems well warranted. Adverse
drug reactions or interactions between new drugs and existing medication
are definitely in the realm of Uncertainty in caring for children across
the age range 0-16. NICE has hitherto sought to make judgements on the
Best treatment (singular) but in an uncertain doctor-child interaction it
may make good economic sense to simultaneously identify 'good enough'
Second-line treatments that can understudy for the 'best' medication in
situtations where the safety of the individual child may preclude using
that most cost effective drug. This 'good enough for some children'
standard is not currently within the expertise of the licensing
authorities, but could become a feature of NICE expertise. In the absence
of safe treatment alternatives (my Second Eleven) the longterm costs to
some children and families (and the Health Service) of adverse drug
reactions could be heavy. For adult healthcare, for which there is much
much more experimental knowledge, the burden of adverse drug reactions is
6.5% of hospital admissions . For childhood medication, what will be
1 Rawlins MD, Culyer AJ. National Institute for Clinical Excellence
and its value judgements. BMJ 2004; 329: 224-7.
2 NICE. Scientific and social value judgements. London: NICE, 2004.
3 Harding A. Study finds US paediatric medical errors kill 4500
children a year. BMJ 2004; 238: 1458.
4 Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ,
Farrar K, Park BK, Breckenridge AM. Adverse drug reactions as cause of
admission to hospital: prospective analysis of 18820 patients. BMJ 2004;
Maintained on at least 5 drugs concurrently.
Competing interests: No competing interests