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Japan orders new tests on bird flu drug

The reputation of flu drug Tamiflu suffered a fresh blow yesterday on Tuesday when the Swiss pharmaceutical company Roche and its Japanese partner announced new clinical trials to establish whether there is a possible link between the drug and dozens of deaths and injuries among Japanese teenagers.

The new research on Tamiflu, which is being stockpiled as the best available treatment in a bird flu epidemic, was recommended by a Japanese health ministry drug safety panel investigating fears that it may have a link to several teenagers who killed or harmed themselves during episodes of extreme mental disorder. In February a boy and a girl, both 14, fell to their deaths.

The ministry said there was no evidence of a causal link between Tamiflu and the symptoms but it ordered doctors not to prescribe it to teenagers, except those suffering extreme flu symptoms.

It advised Roche and Chugai Pharmaceutical, which sells the drug in Japan, to begin pre-clinical and human clinical trials to establish whether Tamiflu could be behind sideeffects such as delirium and delusion.

Chugai said that the results of the research, expected by the end of the year, would be used "for the best possible safety measures for the next influenza season."

It said it would conduct clinical trials using 12 to 30 volunteers, while Roche would conduct toxicity studies using rats to gauge the drug's effects on the brain.

"We are taking the situation seriously and are increasing our efforts to look into whether there is any causality," Chugai said.

This week the health ministry said the number of people found to have behaved abnormally after taking Tamiflu had risen from 128 in April to 211 as of last Saturday. More than 1,300 people have exhibited neuropsychiatric symptoms since the drug went on sale in Japan in 2001, of whom 71 have died. Twenty-seven, most in their teens, fell from buildings.

Roche says studies have repeatedly failed to find a link with abnormal behavior. Tamiflu has been used by 45 million people in 80 countries since it went on the market in 1999. Japan accounts for 70 percent of its use.

Roche said tests had shown children using the drug to treat flu were less likely to show such symptoms than those who were not receiving the treatment.

A study conducted by the US food and drug administration in 2005 found no causal link. Some experts agree that severe flu symptoms may have caused the behavior.

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