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苦杏仁苷:美国食品药品监督管理局(FDA)周边的最终行动。法律进展回顾

Laetrile: end play around the FDA. A review of legal developments.

作者信息

Rosen G M, Shorr R I

出版信息

Ann Intern Med. 1979 Mar;90(3):418-23. doi: 10.7326/0003-4819-90-3-418.

Abstract

We consider here some of the legal and political background behind today's laetrile controversy. First, we provide a brief historical review of our present food and drug legislation and discuss details of these laws with respect to attempts by laetrile's backers to use the courts in the legalization of this compound. We analyze one case, Rutherford v. United States, that was won in the lower courts by the advocates of laetrile and conclude that the courts may have allowed emotionalism to interfere with the process of rational decision-making. On a larger scale, this emotionalism manifests itself as political pressure that may bring about changes in our food and drug legislation. These changes could loosen restrictions on the effectiveness requirement and result in the sacrifice of consumer protection in favor of making available more drugs, some of them ineffective, from which the patient may choose for treatment.

摘要

在此,我们探讨当今苦杏仁苷争议背后的一些法律和政治背景。首先,我们简要回顾一下当前食品和药物立法的历史,并讨论这些法律的细节,涉及苦杏仁苷支持者试图利用法庭使这种化合物合法化的情况。我们分析了一个案例,即卢瑟福诉美国案,在初审法院中苦杏仁苷的支持者胜诉,我们得出结论,法庭可能受到了感情用事的影响,干扰了理性决策的过程。从更大范围来看,这种感情用事表现为政治压力,可能会导致我们的食品和药物立法发生变化。这些变化可能会放宽对有效性要求的限制,导致牺牲消费者保护,以利于提供更多药物,其中一些药物并无效果,患者却可以从中选择用于治疗。

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