Update on unethical use of placebos in randomised trials
Update on unethical use of placebos in randomised trials
复制标题
DOI：
10.1111/1467-8519.00332
复制
发表时间：
2003-04-01
期刊：
影响因子：
2.2
通讯作者：
Rothman, KJ
中科院分区：
文献类型：
--
作者：
Michels, KB;Rothman, KJ
世界医学协会于2000年10月通过的《赫尔辛基宣言》最近（第五次）修订版加强了长期以来禁止提供安慰剂而不是有效治疗的规定。WMA明确表示，如果对某种疾病的有益治疗已经得到认可，那么在研究相同疾病的任何人身上提供安慰剂来代替这种治疗是不道德的。我们之前曾提请注意《宣言》的精神与在随机试验中使用安慰剂对照的常见做法之间的差异，即使存在有效的治疗方法。尽管有《赫尔辛基宣言》的授权和伦理学家和科学家的关注，美国食品和药物管理局（FDA）继续要求和捍卫许多新药开发的有效性和安全性的安慰剂对照证据，即使存在有效的治疗方法。我们认为，FDA为其做法辩护的论据不足以证明违反《赫尔辛基宣言》的医学研究是正当的。
The most recent (Fifth) revision of the Declaration of Helsinki, adopted in October 2000 by the World Medical Association (WMA), reinforces the longstanding prohibition against offering placebo instead of effective therapy. The WMA left no doubt that if a beneficial treatment for a condition has already been recognised, it is unethical to offer placebo in place Of such treatment to anyone in a study of the same condition. We have previously drawn attention to the discrepancy between the spirit of the Declaration and the common practice of using placebo controls in randomised trials even if effective treatment exists. Despite the mandates of the Declaration of Helsinki and concern from ethicists and scientists, the US Food and Drug Administration (FDA) continues to demand and defend placebo-controlled evidence of efficacy and safety for the development of many new pharmaceuticals, even if effective therapy exists. We suggest that the FDA's arguments defending their practice are insufficient to justify medical research that violates the Declaration of Helsinki.