Reactions 512 - 30 Jul 1994

Japan’s drug approval processquestioned

Inadequacies in Japan’s procedures for monitoringand assessing clinical trials are currently under scrutinyfollowing the withdrawal of sorivudine after it wasassociated with several deaths.*

Sorivudine was launched in Japan in September lastyear for the treatment of herpes zoster. However, byNovember, the agent had been associated with 15deaths and numerous serious adverse effects. Accordingto a recent report in the Japanese newspaper, AsahiShimbun, there were 3 deaths in patients receivingsorivudine in combination with other antineoplasticsduring clinical trials. However, Nippon Shoji Kaisha, thecompany who developed sorivudine, only reported 1 ofthese deaths when it submitted the agent for approval.

Masanori Fukushima, an advocate for the revision ofJapan’s clinical trial system, says the sorivudine scandalis ‘shameful’, and adds that this is not an isolated case.According to Fukushima, the government drug approvalprocess in Japan may have failed to detect the potentialproblems with sorivudine because of inadequateexpertise or an inadequate system for assessing clinicaltrials.* See Reactions 476: 2, 6 Nov 1993; see Reactions 476 p2; 800231405

Swinbanks D. Deaths bring clinical trials under scrutiny in Japan. Nature 369: 697,30 Jun 1994 800284172

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Reactions 30 Jul 1994 No. 5120114-9954/10/0512-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved