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为求生存不择手段:一种实验性药物的推广挑战

Anything to Stay Alive: The Challenges of a Campaign for an Experimental Drug.

作者信息

Geffen Nathan

出版信息

Dev World Bioeth. 2016 Apr;16(1):45-54. doi: 10.1111/dewb.12084. Epub 2015 May 15.

Abstract

Drug-resistant tuberculosis (TB) has a high mortality rate. Most medicines used to treat it are poorly tested and have terrible side effects. Activists have campaigned for patients with drug-resistant TB to have access to experimental drugs, particularly one called bedaquiline, before these have been approved by regulatory authorities such as the Food and Drug Administration (FDA) in the United States (US) and the Medicines Control Council (MCC) in South Africa. Some activists have also campaigned for bedaquiline to be approved by regulatory authorities before testing of the drug is completed. These campaigns raise ethical concerns about whether patients should be offered experimental, unapproved, medicines for the treatment of life-threatening illnesses, and if authorities should approve drugs for life-threatening illnesses when vital questions about safety and efficacy remain outstanding.

摘要

耐多药结核病的死亡率很高。用于治疗该病的大多数药物测试不足,且有严重的副作用。活动人士发起运动,呼吁耐多药结核病患者在实验药物(特别是一种名为贝达喹啉的药物)获得美国食品药品监督管理局(FDA)和南非药品控制委员会(MCC)等监管机构批准之前就能使用这些药物。一些活动人士还发起运动,要求在药物测试完成之前就让贝达喹啉获得监管机构的批准。这些运动引发了伦理问题,即是否应该为患有危及生命疾病的患者提供实验性的、未经批准的药物,以及当关于安全性和有效性的关键问题仍未解决时,监管机构是否应该批准用于治疗危及生命疾病的药物。

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