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Experts question wisdom of stockpiling oseltamivir

London

Andrew Cole

Stockpiling supplies of the antiviral drug oseltamivir (Tamiflu) for use in the event of a flu epidemic was questioned by experts on both sides of the Atlantic this week.

The UK government’s decision to order 14.6 million doses of was questioned by Joe Collier, professor of medicines policy at St George’s Hospital Medical School, London, and former editor of the Drug and Therapeutics Bulletin.

"I would like to know what evidence there is that Tamiflu actually alters mortality," he said. "And if it doesn’t then what are we doing? What it certainly does is shorten the illness by a day, but the question is—does that matter?"

On the other side of the Atlantic the federal health minister for Canada, Ujjal Dosanjh, told listeners to an interview on a Canadian Broadcasting Corporation radio programme ("The Current," 27 Oct) that oseltamivir did not prevent infection with the flu virus and that at best it would reduce the severity of the illness (BMJ 2003;326:1235).

The demand for oseltamivir has risen dramatically in recent months amid fears of the spread of avian flu, which has led to more than 60 deaths in east Asia and the culling of 150 000 birds. The drug’s manufacturer, Roche, recently suspended supplies to pharmacies in Canada and the United States to protect stocks for use when the flu season begins.

In the United Kingdom the drug is increasingly advertised online, and pharmacies have reported a big increase in inquiries from the public. Although GPs are currently able to prescribe it on the NHS only if someone has both flu and a chronic condition, any patient who gets a private prescription for the drug can obtain it from a pharmacist for £25 for a pack of 10 pills.

The UK health department says that oseltamivir will be the "first line of defence" for the treatment of flu if there is a pandemic. Apart from ordering 14.6 million doses of the drug from Roche to be produced by September 2006, it has arranged for larger than normal amounts to be made available this winter to treat people who are at highest risk from normal flu.

A department spokeswoman said that the stockpile for a pandemic was guaranteed "whatever happens in the rest of the world."

"Our only concern is that if people are rushing out and getting private prescriptions now then there may be short supplies for those who really need it when the flu season proper arrives," she said.

In response to rising demand Roche has increased production of the drug by nearly 10-fold in the last 2.5 years. It is expected to record sales of $925m (£522m; €770m), more than three times last year’s $266m.

The spokeswoman also confirmed that the department was at an advanced stage of discussions about licensing other companies to make the drug increase overall supplies. More than 100 companies had contacted the department in the last fortnight to offer their services, she said.

"Obviously Roche is interested in bringing more product to the market. But it is very important that the drug is manufactured according to very particular criteria."

The department’s clinical guidance says that oseltamivir may be most effective when patients have not only flu symptoms but also a fever and have had symptoms for no more than two days. It accepts that there is no evidence that it cuts mortality.

· The World Health Organization has asked the Chinese government to supply more information about tests on a 12 year old girl who died of pneumonia but who the authorities say tested negative for the H5N1 avian flu strain. She died after eating poultry meat in her village in Hunan province, the site of one of several outbreaks of H5N1 among poultry in China in recent weeks.