Pressures on NICE

It would be sensible for the NHS not to have to pay for  new drugs unless they are at least as good as older ones, nor for expensive drugs whose benefits are uncertain. The National Institute for Health and Clinical Excellence (NICE) has been created to avoid both of these. NICE appraises technologies that are available to the NHS and recommends whether they should be used unreservedly,  with restrictions, or not at all.

Pharmaceutical companies on average spend over $800m to develop and license a new drug, so they are understandably interested in the financial returns. An obvious insurance against loss is to produce a drug that is clearly beneficial and whose costs are proportionate. Even if a new drug offers only slight benefits at an inflated cost, a company may be able to persuade doctors or patients of its value by marketing. It can then hope for sales independent of guidance from NICE or other expert bodies. Companies can also sell drugs by re-labelling as diseases normal phenomena such as male pattern baldness and social phobia in order to promote drug treatment for  them.

The manufacturer or sponsor of a product has a key role in the appraisal process through the submission of data to NICE's evidence review group. Industry funded randomised trials are more likely to favour the treatment under test, and authors are more likely to be positive in their conclusions if a randomised trial is funded by a for-profit organisation. Certainly, expected cost-utilities can vary greatly from one study to another. In the case of photodynamic therapy, industry estimated the cost of averting two years of blindness as £70,000, whereas academic analysis suggested costs between £150,000 and £300,000.

Companies also harness the media to support their views in battles with NICE. If NICE gives restrictive guidance, drug companies issue press releases decrying the judgment. Pfizer described the recent decision not to recommend inhaled insulin as "perverse," and Link Pharmaceuticals claimed NICE was denying "potentially life-prolonging treatments" to patients with brain tumours.

Patient groups have been described as conduits for drug companies to promote their products and as "ground troops" to be used to lobby governments for increased access to new drugs. A recent survey found that 76% of patient groups based in the European Union received support from drug companies, although how much they received was unclear. The House of Commons Health Select Committee has advised that measures be taken to limit the influence of industry on patient groups.

The influence of patients and patient groups can be seen even before a NICE appraisal has been commissioned. Trastuzumab has  only just been licensed for use in early breast cancer, its longer term efficacy is uncertain, and its propensity to cause myocardial damage in patients who have taken anthracyclines is worrying. The cost of treating a patient with trastuzumab in the United Kingdom is about the same as the average annual income.

Dying patients denied life saving drugs make compelling copy. Better still, when heartless bureaucrats are persuaded to change their minds under media pressure, the media can take the credit for saving the patient. The Manchester Evening News even received an award for its campaign over trastuzumab. Newspaper columnists such as Clare Rayner and Thomas Stuttaford have also launched populist attacks on NICE rationing.

Ministerial interventions may complicate matters. While he was a health minister, Stephen Ladyman commented on preliminary guidance that recommended the withdrawal of drugs for Alzheimer's disease. He stated that "they [NICE] have to look at the wider impact of this decision. It may well be that once they have looked at the extra evidence, they will come to a different decision." Even before trastuzumab has been licensed for treatment of early breast cancer, Patricia Hewitt, the secretary of state for health, has stated that primary care trusts "should not refuse to fund Herceptin [trastuzumab] solely on the grounds of its cost." She has instituted genotyping of all breast cancers, so fostering expectations of trastuzumab treatment directed at the 20% of tumours that are HER-2 positive.

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Improving Hospital Mortality

There are wide variations in hospital mortality. Much of this variation remains unexplained and may reflect quality of care.

A study was set up in a large acute hospital in an urban district in the North of England as a ‘before and after’ evaluation of a hospital mortality reduction programme.

An audit of hospital deaths was set up to identify processes of care. A hospital mortality reduction group was set up with senior leadership and support to ensure the alignment of the hospital departments to achieve their goal. There was whole system working across a health community to provide appropriate end of life care. Training and awareness in processes of high quality care such as clinical observation, medication safety and infection control.

As a result the Hospital standardized mortality ratios fell significantly in the 3 years following the start of the programme from 94.6 in 2001 to 77.5 in 2005. This translates into 905 fewer hospital deaths than expected during the period 2002-2005.

It is believed that improving the safety of hospital care and reducing hospital deaths provides a clear and well supported goal from clinicians, managers and patients. Good leadership, good information, a quality improvement strategy based on good local evidence and a community-wide approach may be effective in improving the quality of processes of care sufficiently to reduce hospital mortality.

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Speculum examinations without stirrups

The pelvic examination using a vaginal speculum is one of the most common medical procedures performed by doctors and experienced by women. About 55 million smear tests are performed in the United States every year. Medical schools uniformly teach a single way to position a woman for pelvic examinations—in the dorsal lithotomy position with feet in stirrups.

But women feel less vulnerable and experience less discomfort when speculum examinations (as part of routine gynaecological examination) are carried out without stirrups.

In a recent study the authors randomised 197 adult women from a US family medicine outpatient clinic who were undergoing routine gynaecological examination and cervical smear to examination with or without stirrups.

When the women's perceived levels of physical discomfort were measured on 100 mm visual analogue scales, the level for those examined without stirrups was 17.2 compared with 30.4 in the stirrups group. Sense of vulnerability in the group of women examined without stirrups was reduced from 23.6 to 13.1, whereas sense of loss of control was the same in both groups

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