Dalkon shield affair: a bad lesson in science and decision-making.
Dalkon shield affair: a bad lesson in science and decision-making.
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达尔康盾事件：科学和决策方面的一个糟糕的教训。
DOI：
10.1126/science.185.4154.839
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发表时间：
1974
期刊：
影响因子：
56.9
通讯作者：
D. Knopman
中科院分区：
文献类型：
--
作者：
B. Culliton;D. Knopman
数月来对 Dalkon Shield 宫内节育器 (IUD) 的困惑和怀疑正在逐渐结束，最终令人不安。在盾牌安全性不确定的整个夏天，人们都期待着一场盛装公开的证据听证会。该听证会于 8 月第三周在位于马里兰州罗克维尔 Parklawn 大楼的食品和药物管理局 (FDA) 总部举行，共有约 200 人参加。根据结论，FDA 的一个特别小组被说服继续暂时停止该防护罩的销售。根据自 6 月下旬制造商自愿暂停销售和分销以来收集的信息，FDA 在最近的听证会上透露，最初可能与护罩有关的严重问题数量大约增加了一倍，目前总数为 11 例死亡和 209 例受感染堕胎。
Months of confusion and doubt about the Dalkon shield intrauterine device (IUD) are winding down to an unsettling end. Throughout a summer of uncertainty about the safety of the shield, people were anticipating a full-dress public hearing on the evidence. That hearing, which drew about 200 persons, was held during the third week of August at Food and Drug Administration (FDA) headquarters in the Parklawn building in Rockville, Mary-land. By the conclusion, a special FDA panel was persuaded that sales of the shield continue to be temporarily sus-pended. From information gathered since the voluntary suspension of sales and distribution by the manufacturer in late June,'the FDA disclosed at the recent hearings that the original number of serious problems presumably associ-ated with the shield had about doubled, the total now being 11 deaths and 209 infected abortions.