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Flu Pandemic - More Doubts
Over Key Drug Studies
Show Resistance To Tamiflu

By Sarah Boseley
Health Editor - The Guardian
 12-22-5
 
Serious questions are raised today about the ability to combat an anticipated bird flu pandemic following the deaths of two people who were being treated with the drug the world is stockpiling as a safeguard against the virus.
 
To the dismay of medical experts and concern among those responsible for the worldwide efforts to fight a pandemic, the H5N1 bird flu virus in the bloodstream of the two patients in Vietnam rapidly developed resistance to the drug, Tamiflu. One, a 13 year-old girl, appeared to be stable at first and then rapidly worsened as the virus mutated, became more aggressive, and eventually killed her.
 
The deaths are reported today in the respected New England Journal of Medicine by doctors funded by the British Wellcome Trust working in Vietnam. They urge changes to the global plans for fighting a flu pandemic. Other antiviral drugs are needed alongside Tamiflu, they say.
 
An eminent professor at Cornell University in New York calls the report "frightening" in a commentary in the journal. Anne Moscona, from the department of paediatrics, microbiology and immunology at Weill medical college, says Tamiflu-resistant H5N1 "is now a reality", and calls for efforts to prevent individuals stockpiling the drug. Its misuse, she says - by people who, for instance, take too low a dose - will breed resistance and further undermine its effectiveness if a pandemic sweeps the world.
 
The British government has ordered 14.6m courses of Tamiflu, enough for a quarter of the population. Its maker, Roche, cannot keep up with demand, however, as most countries attempt to stockpile. So far, 3.5m doses have been delivered, and the rest is due by next September. At a conference last month, the chief medical officer, Sir Liam Donaldson, made it clear that Tamiflu was Britain's first line of defence. But he acknowledged that nobody knew for sure how the drug would work in a pandemic against a strain of flu yet to be encountered."It doesn't cure flu, it simply reduces the severity of the attack," he said.
 
Last night, a spokeswoman for the department of health said Tamiflu was selected on the strength of independent advice. "Internationally, this is agreed as the product of choice," she said. But she added that the research would be carefully considered as part of the government's constant review of its antiviral strategy.
 
Alan Hay, head of the WHO Influenza Centre of the MRC National Institute of Medical Research, said it was important to remember that four of the eight Vietnamese patients in the study survived after their treatment with Tamiflu. But, he said, the report was of "very significant concern in regard to how we use these drugs to treat people". It had already been recognised that resistance could build against Tamiflu. In Japan, one in six children treated with the drug for ordinary forms of flu developed resistance. It appeared, he said, that resistance was more likely in children because they had not been exposed to the prevailing strains of flu. In the case of bird flu, however, nobody has been exposed.
 
The report in the NEJM by Jeremy Farrar and colleagues from the Oxford University Clinical Research Unit at the hospital for tropical diseases in Ho Chi Minh City, Vietnam, reveals that they confirmed a resistant form of bird flu in two out of eight patients who were being treated with oseltamivir, of which Tamiflu is the brand name. One was treated at an early stage of infection, when Tamiflu is supposed to be most effective.
 

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