Kin of cancer drug victim may sue firm

(The Japan Times) — The father of a woman who died from acute side effects of the controversial cancer drug Iressa is considering filing a compensation suit against its importer for failing to swiftly alert medical institutions to the drug's dangers.

Akio Chikazawa, 59, said Saturday he is consulting lawyers with experience in cases of medicine-induced illnesses and deaths and is also considering suing the government, citing doubts over the screening process by the health ministry, which approved the drug in a short period of time.

Iressa, as a new type of medicine for lung cancer, was selected for a fast-track screening procedure for approval by the Ministry of Health, Labor and Welfare. After five months of expedited examination, Japan approved the drug last July, becoming the first country in the world to do so.

Chikazawa's daughter, Mitsuko, who lived in the city of Saitama, died last October at the age of 31 from an acute lung injury believed to have been caused by interstitial pneumonia, a potential side effect of the drug. Iressa is imported by AstraZeneca K.K., the Japanese unit of Anglo-Swedish pharmaceutical house AstraZeneca PLC.

"I do not want the death of my daughter, who suffered so much from the side effects, to be wasted," Chikazawa said. "I have to do something so there will be no more victims of the side effects."

He is calling for other bereaved families to jointly file a suit. "I believe there are many bereaved relatives who are bearing the pain silently, but I want us to raise our voices together."

After the drug was approved, doctors nationwide soon reported a series of acute side effects, mainly interstitial pneumonia.

More than 180 of the 23,500 people who have been given the drug have died so far.

Internal documents of the Osaka-based drug importer showed it was aware of 13 side effect cases, including seven deaths, by early September last year and has decided to consider revising package inserts to warn medical institutions of the dangers of the side effects.

However, AstraZeneca's Japan unit did not make any revisions until it was instructed by the health ministry on Oct. 15 to urgently release safety information on the drug.

The importer claimed it had proceeded with the changes cautiously, in order not to cause problems with misleading information, and that it has been telling doctors that interstitial pneumonia is one potential side effect.

The health ministry issued an emergency warning in late December, including the compulsory hospitalization of people during the first four weeks they are administered the drug.