Relenza: a drug too far?

Should Relenza have been given on the NHS last year?

Relenza can reduce the length of flu infections by a few days, but a government decision not to supply it on the NHS led to a huge political row.

It was the first big test of the government's advisory committee, the National Institute for Clinical Excellence (NICE), which recommended that the drug would not necessarily help those at the most risk of serious harm from the virus.

Relenza

It prevents the virus from replicating

Flu illness could be shortened by two or three days

It costs £24 for a course of treatment

It is less certain whether it works as well in the elderly

The drug comes in powder form, and is delivered through an inhaler.

If taken at the onset of flu, it can cut short the infection in otherwise healthy adults.

It works by suppressing the replication of flu viruses, which in turn limits the typical flu symptoms of fatigue and fever.

It is made by GlaxoWellcome, which predicted that in a normal flu season, some 500,000 doses, each costing £24, would be needed by the NHS.

However, its predictions did not tally with those of NICE experts, who said that in the event of an epidemic, the drug could cost the UK taxpayer as much as £115m.

That might be acceptable if the drug could prevent a significant proportion of the thousands of deaths attributed to flu-related illness each year.

It might be acceptable if Relenza could greatly reduce the need for elderly people struck down by flu to spend long periods recovering in nursing homes or hospitals.

Can Relenza help elderly patients?

However, the assessors at NICE were not convinced that either of these would happen.

Their job is to look at the available evidence on how well a drug works, such as clinical trials, and balance this against the potential cost to the NHS.

The drug company is invited to submit all the evidence in favour of the drug, and GlaxoWellcome duly did this.

But the NICE experts decided, that while there was plenty to suggest that the drug worked well in average, healthy, people, they were less satisfied with the evidence supplied about the groups of people about which they were interested.

For the average healthy, younger person who has no underlying disease, flu is an unpleasant inconvenience - but for the elderly and those already sick, it is a potential killer.

It is among these groups that deaths occur, and large bills for the NHS are run up.

Without strong evidence that it would work among vulnerable patients, NICE recommended that doctors should not be allowed to prescribe it on the NHS.

Then Health Secretary Frank Dobson endorsed this advice.

Decision attacked

Immediately Glaxo dismissed the accusation that Relenza had not been tested on sufficient numbers of high risk groups.

Chairman Sir Richard Sykes said: "There is absolutely no question about the efficacy of Relenza.

"Of course we don't have statistically significant data to show that this drug works in specific groups - that never happens with drugs, drugs are tested in big populations."

The drug industry believes that the creation of NICE has created a system in which too many hurdles are being placed between their drugs and the NHS.

The government has been accused of adopting an "antagonistic" attitude towards pharmaceutical firms.

Sir Richard warned that leading firms could well pull out of the UK and develop their products elsewhere.

Many doctors, however, supported the Relenza ban, fearing that they would be inundated with requests for the drug.

However, NICE has been told to complete a further, more comprehensive review of Relenza, and is due to report in the late Autumn.

There have been reports that doctors will be allowed to prescribe it to the elderly, as well as people with breathing or heart problems.

NICE was supposed to speed up the introduction of new drugs by issuing swift guidelines for health authorities and hospitals.

If a U-turn emerges from its latest deliberations, questions will certainly be asked about why an effective drug was kept out of the NHS for an entire year.