Abnormal behavior is already considered a side effect of the flu pill. And that’s certainly what Japan’s health ministry is displaying. The ministry was “negative” in 2006 on the possibility of a causal relationship between Tamiflu and abnormal behavior, despite reports from at least two doctors who said links couldn’t be denied in the deaths of two teenagers, reports Kyodo News.

No one seems to know why the ministry pooh-poohed the possibility, but the ministry says that, even though experts were interviewed earlier this year, documents that would lead to such a conclusion don’t exist, sources told Kyodo. Yet it seems another government agency does have records.

In reports filed with the Pharmaceuticals and Medical Devices Agency, a government body that collects and provides info on side effects, Chugai Pharmaceutical attached opinions from two docs who entertained the possibility that causal relationships could have been a factor in two Tamiflu cases in 2004 and 2005.

The first case involved a 17-year-old high school student. A report on the case submitted to the agency by Chugai Pharmaceutical says the youth developed a fever, was diagnosed with the flu and treated at a hospital. Hours after taking Tamiflu, he dashed out of his home barefoot in the snow, climbed over a guardrail and onto a highway where he was hit by a truck and killed.

In an opinion attached to the report, the treating doctor said he doesn’t think the teen developed influenza-caused encephalopathy because he was clear-headed and talked with hospital staff before taking the drug. The student “showed the abnormal behavior about two hours after taking (Tamiflu) so that the causal links with it cannot be denied,” the doctor said in the opinion.

The 2005 case involved a 14-year-old junior high school student who jumped to his death from an apartment. In a report on the case by Chugai, the doctor who was in charge of the teenager said: “What I can say is that the use (of Tamiflu) might be linked. It is unclear whether the student’s fall was caused by side effects (of the drug).”

After receiving persistent reports of abnormal behavior linked to Tamiflu, the health ministry banned prescription of the drug on March 20 to people aged 10 to 19. On April 4, the health ministry said that as of March 21, 128 people — predominantly teenagers — had reportedly exhibited abnormal behavior after taking Tamiflu, which went on sale in Japan in February 2001.

There are two issues here. The first is the extent to which Tamiflu is problematic. The second is the extent to which Japan’s health ministry is problematic. Any health ministry that doesn’t keep records - especially concerning controversial drugs - needs to be investigated. And at this point, an overhaul would be considered normal behavior.

Despite fears in Japan, Tamiflu has become a blockbuster for Roche, which sells the pill and also owns Chugai. Even though few people have bird flu, the threat of a pandemic has rung Roche’s register repeatedly, The Financial Times reports. “This is a very unique situation,” concedes David Reddy, Roche’s pandemic taskforce leader, who has been diverted to the project full-time from work on more mainstream medicines in the company’s virology division.

Full story in The Japan Times;
The Financial Times (subscription required).[tags]Chugai Pharmaceuticals, Roche, Tamiflu[/tags]