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Friday, October 1, 1999 Published at 10:46 GMT 11:46 UK


Relenza: The implications

GPs may not be able to write NHS prescriptions for Relenza

What does a decision not to give a controversial flu drug on the NHS mean to patients, the government and the drugs industry?

The job of the National Institute of Clinical Excellence, steering a course through some of the most controversial issues facing the NHS, was never going to be straightforward.

Whatever its decision on the flu drug Relenza, NICE would have faced criticism from some quarter, be it health managers, patient pressure groups, doctors or the powerful pharmaceutical industry lobby

For the majority of patients, the Relenza decision means the expense of paying for the drug privately - the treatment costs £24 for a five day course - or the inconvenience of about 40% more time suffering from 'flu.

There are bound to be accusations that this is rationing by the backdoor, although strictly speaking the fact that nobody will get the drug on the NHS means it is not.

Could Relenza save lives?

The key question for NICE was whether Relenza could help those vulnerable people who are more likely to die following infection with flu - the elderly and sick.

The experts at NICE say there is not enough evidence from the clinical trials already carried out to demonstrate that these groups could be helped - and lives saved.

But some flu experts say that high risk groups could be helped.

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Dr Doug Fleming, a flu expert, said: "In some trials the effectiveness among high-risk groups has not appeared statistically significant because they are not statistically significant groups themselves."

The recommendation is bound to be a relief to the government, as its own experts were predicting a bill for the NHS in excess of £100m in a flu epidemic year.

The National Prescribing Centre, which advises the NHS, said that 4.8m people were likely to be given the drug in such circumstances.

GPs warned that a flood of people arriving at surgeries demanding the drug could overwhelm them, and prevent any other work being completed.

Glaxo Wellcome's own analysis, based on a normal year, suggested 500,000 prescriptions.

Harm to drugs industry Glaxo is preparing for a "gloves off" fight with NICE - industry representatives have always been highly suspicious of the institute, and the motives behind its inception.

NICE is keen for drugs firms to carry out their trials not just on carefully selected groups of people, but on the sort of people who would be given it in real life.

In particular, they claim that an insistence on exhaustive, and expensive "real life" trials being carried out before a drug can be endorsed for NHS use will stifle the active UK research scene.

They claim that pharmaceutical companies may be unwilling to launch new products in this country if NICE forces makers to jump through too many hoops.

There is the danger that the evidence required by NICE will be gathered in other countries - meaning that innovative and life-saving medicines might be launched elsewhere years before the UK.

Economic arguments

Another criticism that may be levied at NICE is that it has not fulfilled a pledge to examine all the economic arguments for the drug, not simply its clinical effectiveness.

One estimate says that 10% of all sickness days in the UK can be attributed to flu.

If that could be reduced even by a fraction, the economy in general would benefit greatly.

Health Secretary Frank Dobson will have to move quickly to either endorse, or reject the NICE recommendation, as the flu season is already arriving.

The key test, if he agrees with NICE, will be whether he can convince the public that few of those who die from flu this winter could have been helped by the drug.

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