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Gaps in the Safety Net
Science, Vol 307, Issue 5707, 196-198 , 14 January 2005
昨年の COX2 阻害剤事件(Vioxx と Cereblex)や Aleve の件 を振り返って現状の safety net の課題をレポートしている．Iressa の件は述べられていない．煎じ詰めると Phase IV(市販後調査)をしっかりせいということのようだ．ちなみにソースは明記されていないけど

FDA generally relies on companies to run postmarketing trials, called pahse IV studies,
often requesting them as a condition for a drug's approval.
中略
An FDA analysis released in 2003 found that more than 50% of pahse IV studies
don't even get started.

なのだそうだ．