Biological Warfare and Snake Venom for Poliomyelitis and ALS: The Little Known Entwined History of Failed Ethics and a Reasonable Therapeutic Hypothesis

M RiveraVictor
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Abstract

This paper describes a complicated history taken place during World War II (WWII) when military intentions for acquiring biological weapon superiority knowledge was obtained in some cases through atrocious investigations in human beings disregarding ethical and moral principles. After the war, Murray Sanders (1910-1988), a young military officer and American scientist became incidentally entwined with the U.S. military concern over the Japanese bacteriological knowledge, unbeknown by the Allies that was being acquired through human experiments. In a second stage of his career (between 1949 and 1983), Sanders investigated the potential therapeutic characteristics of snake venom, obtained several U.S. patents on the formulation and an Investigational New Drug (IND) license from the Food and Drug Administration (FDA). While he was well-intentioned and cared for his patients, Sanders utilized protocols non-sanctioned by Independent Ethics Committees and openly administered detoxified snake venom neurotoxin or Modified Neurotoxin (MNT) to patients with poliomyelitis and later used it in Amyotrophic Lateral Sclerosis (ALS). While Sanders reported “partial” efficacy of MNT in ALS this was not confirmed with placebo-controlled, IRB-approved clinical trials. Two well-designed placebo-controlled clinical trials performed by independent institutions sanctioned by the FDA and approved by their respective Institutional Review Boards did not yield positive results. Findings were reported in the neurological literature. Later in life Sanders was requested to testify in a Congressional Hearing on the WWII Japanese bacteriological warfare experiments and the U.S. strategy to condone culpability of war crimes in exchange for military information. This article reflects on a scientific effort spanning through several epochs and personae interacting with diverse philosophies and different objectives performing research in human beings. *Corresponding author: Victor M Rivera, MD, FAAN, Distinguished Emeritus Professor, Department of Neurology, Baylor College of Medicine, Houston, Texas, USA ReView ARticle
生物战和蛇毒治疗脊髓灰质炎和肌萎缩侧索硬化症:鲜为人知的失败伦理和合理治疗假设的交织历史
本文描述了第二次世界大战期间发生的一段复杂的历史,在某些情况下,获取生物武器优势知识的军事意图是通过对人类的残暴调查而获得的,无视伦理和道德原则。战争结束后,默里·桑德斯(Murray Sanders, 1910-1988),一位年轻的军官和美国科学家,偶然地卷入了美国军方对日本人的细菌知识的关注中,这些知识是盟军通过人体实验获得的,却不为人知。在他职业生涯的第二阶段(1949年至1983年),桑德斯研究了蛇毒的潜在治疗特性,获得了几项配方的美国专利,并获得了食品和药物管理局(FDA)的研究新药(IND)许可证。虽然他的初衷是好的,也很关心他的病人,但桑德斯采用了未经独立伦理委员会批准的方案,公开给脊髓灰质炎患者使用解毒的蛇毒神经毒素或改良神经毒素(MNT),后来又将其用于肌萎缩性侧索硬化症(ALS)。虽然Sanders报告了MNT对ALS的“部分”疗效,但这并没有得到安慰剂对照、irb批准的临床试验的证实。两个设计良好的安慰剂对照临床试验由FDA批准的独立机构进行,并由各自的机构审查委员会批准,但没有产生积极的结果。研究结果已在神经学文献中报道。后来,桑德斯被要求在国会听证会上就二战日本细菌战实验和美国宽恕战争罪行以换取军事情报的战略作证。这篇文章反映了跨越几个时代和人物的科学努力,与不同的哲学和不同的目标相互作用,在人类身上进行研究。*通讯作者:Victor M Rivera,医学博士,FAAN,美国德克萨斯州休斯顿贝勒医学院神经内科名誉教授
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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