印度沙利度胺的历史。

IF 0.9 2区 哲学 Q4 HEALTH CARE SCIENCES & SERVICES
Ludger Wimmelbücker, Anita Kar
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引用次数: 0

摘要

与众所周知的胚胎毒性药物沙利度胺(thalidomide)的故事不同,在一些国家,沙利度胺是造成大量出生缺陷的原因,而在印度,关于沙利度胺的历史信息有限。它在2002年之前的存在被认为是微不足道的,当时该国颁发了第一个含有沙利度胺的制剂的销售许可证。这篇文章挑战了这一观点,表明毒品在1960年左右通过前葡萄牙领土果阿进入印度次大陆。我们研究了从20世纪60年代中期到现在,其在印度的分布、使用和监管的后续发展。殖民遗产是沙利度胺早期出现在印度次大陆的一个重要解释。它们也影响了它在1965年后作为治疗麻风病反应的药物在印度的重新出现。我们确定了这一进程中的关键行为者:最初免费提供沙利度胺的德国生产商、为国际非政府组织工作的欧洲医生、支持临床试验、后来劝阻使用该药物的世界卫生组织(世卫组织)、最后是限制其分销、后来迅速为私营部门生产和销售沙利度胺及其类似物开辟道路的印度国家机构。最后,我们讨论了沙利度胺引起的出生缺陷的风险,通过对印度的监管规定和出生缺陷监测的现状进行了批判性的审视。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A history of thalidomide in India.

In contrast to the well-known stories of the embryotoxic drug, thalidomide, in countries where it was responsible for large numbers of birth defects, there is limited information on its history in India. Its presence before 2002, when the country issued the first marketing licence for a thalidomide-containing preparation, is assumed to be negligible. This article challenges this view by showing that the drug entered the Indian subcontinent through the former Portuguese territory of Goa around 1960. We examine the subsequent development of its distribution, use and regulation in India from the mid-1960s up to the present situation. Colonial legacies are a crucial explanation for the early appearance of thalidomide on the Indian subcontinent. They also influenced its re-emergence as drug for treating leprosy reactions in India after 1965. We identify key actors in this process: the original German producer that delivered thalidomide free of charge, European doctors who worked for international non-governmental organizations, the World Health Organization (WHO), which supported clinical trials and later discouraged the use of the drug, and finally the Indian state institutions that limited its distribution and later quickly opened the way for the private sector to produce and market thalidomide and its analogues. Finally, we discuss the risk of thalidomide-induced birth defects by casting a critical look on the present state of regulatory provisions and the monitoring of birth defects in India.

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来源期刊
Medical History
Medical History 医学-科学史与科学哲学
CiteScore
1.60
自引率
0.00%
发文量
25
审稿时长
>12 weeks
期刊介绍: Medical History is a refereed journal devoted to all aspects of the history of medicine and health, with the goal of broadening and deepening the understanding of the field, in the widest sense, by historical studies of the highest quality. It is also the journal of the European Association for the History of Medicine and Health. The membership of the Editorial Board, which includes senior members of the EAHMH, reflects the commitment to the finest international standards in refereeing of submitted papers and the reviewing of books. The journal publishes in English, but welcomes submissions from scholars for whom English is not a first language; language and copy-editing assistance will be provided wherever possible.
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