It’s one thing to get a drug approved for use it’s quite another for the National Health Service to agree to adopt it.
GlaxoWellcome found this out to its cost after it developed Relenza (zana-mivir), the first drug for treating influenza.The stumbling block proved to be the National Institute for Clinical Excellence (NICE), which assesses for the NHS the effectiveness and cost effectiveness of drugs and treatments.
It found the drug wanting on both counts when it reviewed it in October, 1999. The Institute felt that there was not enough research to suggest that ‘at risk’ patients people aged over 65 years or with an existing condition that might make influenza a more severe problem would benefit from the drug.
Separately, the US Food and Drug Administration (FDA) also noted that wheezing had occurred in some patients with mild or moderate asthma after taking the drug.
At ï¿½24 for a five day course of treatment, the drug would cost the NHS up to ï¿½15 million a year if there was a ‘flu epidemic.
Thirteen months later and NICE now says the drug can be prescribed to people at risk.
NICE says that further analysis suggests that the drug reduces symptoms among the ‘at risk’ group by 1.2 days and that, overall, it reduces the risk of complications by 6 per cent.
But there is one important dissenting voice. The Drug and Therapeutics Bulletin, whose editor Professor Joe Collier was part of the NICE committee that assessed zanamivir, believes a wrong decision has been made.
The Bulletin maintains that the study is flawed, and does not focus on ‘at risk’ patients as NICE believes. Even if it did, the fact that it reduces the duration of symptoms by one day is hardly
compelling, and nobody has tested the drug against over the counter remedies such as paracetamol and ibuprofen.
NICE also does not touch on the increased risk of bronchospasm, particularly among patients with asthma or chronic pulmonary disease.
All of which leaves the health professional with a dilemma to be cautious or NICE.