Lynch Holly Fernandez
Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, USA.
Ann Health Law. 2007 Winter;16(1):79-138, table of contents.
This article discusses the Best Pharmaceuticals for Children Act and the FDA's request for placebo-controlled studies of drugs to treat OCD and depression in children. First, the article explains the need to test drugs in children and examines the reasons this testing has not occurred. Next, the article describes the legislative and administrative responses to remedy this lack of research and assesses the ethics and legality of their implementation. The article concludes that these initiatives are legally and ethically acceptable until a safe and effective treatment is determined--at which point the use of placebos in pediatric testing must be replaced with active controls.
本文讨论了《儿童最佳药品法案》以及美国食品药品监督管理局（FDA）要求对治疗儿童强迫症和抑郁症的药物进行安慰剂对照研究的情况。首先，文章解释了在儿童中测试药物的必要性，并审视了此类测试尚未开展的原因。接下来，文章描述了为弥补这一研究不足而采取的立法和行政措施，并评估了这些措施实施的伦理和法律问题。文章得出结论，在确定安全有效的治疗方法之前，这些举措在法律和伦理上是可以接受的——届时儿科测试中使用的安慰剂必须被活性对照所取代。
