Sorivudine Deaths: Japan's CPAC "Not To Blame"

The members of Japan's Central Pharmaceutical Affairs Council, the leading advisory body to the Pharmaceutical Affairs Bureau, cannot be held responsible for the deaths of 15 people in clinical trials with the antiviral Usevir (sorivudine), developed by the drug manufacturer and wholesaler Nippon Shogi Kaisha Ltd, says the Council's chairman, Tosio Nanbara.

Prof Nanbara said all members of the relevant committees, subcommittees and executive committees of the CPAC "did their best" with the drug during its New Drug Application examination process, notes Pharma Japan. Nevertheless, he added: "I greatly regret that we could not foresee the onset of side effects, although we did our best to fulfil our duties."

"When we look at the examination process in retrospect," said Prof Nanbara, "there is always something we regret, but all members are doing their best at all times and I don't think there was any problem with their job performance."