粪便和寄生虫:不道德的FDA过度监管。

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2014-01-01
Kenneth A Young
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引用次数: 0

摘要

从卫生假说中诞生的疗法,如蠕虫疗法和粪便细菌疗法,为FDA的制度盲目性提供了一个令人信服的例子。与传统的药物治疗模式不同,基于卫生假说的疗法旨在通过重新引入曾经被认为是完全负面的生物体来解决或缓解疾病。虽然前者仍然存在负面影响和安全性问题,但后者基本上不存在这些问题。尽管如此,FDA还是选择对蠕虫疗法和粪便细菌疗法的使用进行监管。这种以疗效为名限制医患自主权的做法代价高昂,而且是不道德的。
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Of poops and parasites: unethical FDA overregulation.

Therapies born out of the Hygiene Hypothesis--such as helminthic therapy and fecal bacteriotherapy--provide a compelling example of the FDA's institutional blindness. Unlike the traditional pharmaceutical model of treatment, therapies based in the Hygiene Hypothesis purport to resolve or alleviate conditions by reintroducing organisms once thought to be wholly negative. While questions of negative effects and safety remain in the former, they are largely absent in the latter. Nonetheless, the FDA has chosen to regulate the use of both helminthic therapy and fecal bacteriotherapy. Such restriction of doctor-patient autonomy in the name of efficacy is costly and unethical.

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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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