Japan's drug approval process questioned

Inadequacies in Japan's procedures for monitoring and assessing clinical trials are currently under scrutiny following the withdrawal of sorivudine after it was associated with several deaths. *

Sorivudine was launched in Japan in September last year for the treatment of herpes zoster. However, by November, the agent had been associated with 15 deaths and numerous serious adverse effects. According to a recent report in the Japanese newspaper, Asahi Shimbun, there were 3 deaths in patients receiving sorivudine in combination with other antineoplastics during clinical trials. However, Nippon Shoji Kaisha, the company who developed sorivudine, only reported 1 of these deaths when it submitted the agent for approval.

Masanori Fukushima, an advocate for the revision of Japan's clinical trial system, says the sorivudine scandal is 'shameful', and adds that this is not an isolated case. According to Fukushima, the govern­ment drug approval process in Japan may have failed to detect the potential problems with sorivudine because of inadequate expertise or an inadequate system for assessing clinical trials. * See Inphnnna 912: 21, 6 Nov 1993; 80023J405 Swinbanks D. Deaths bring clinical trials under scrutiny in Japan. Nature 369: 697.30 Jun 1994 .002.<1"

0156·2703194/0948·00021/$01.00" Adis International Limited 1994. All rights reserved

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INPHARMA'" 30 Ju11994