Gabriel Joseph M
Medical Humanities and Social Sciences, College of Medicine, Florida State University, Tallahassee, Florida 32306-4300.
J Hist Med Allied Sci. 2014 Oct;69(4):604-32. doi: 10.1093/jhmas/jrt040. Epub 2013 Aug 29.
This article provides a detailed analysis of the origins and significance of the 1926 clinical trial of Sanocrysin, a gold compound thought at the time to be useful in the treatment of tuberculosis. This experiment is generally considered to be the first clinical trial in the United States that used a formal system of randomization to divide research subjects into treatment and nontreatment groups; it was probably also the first clinical trial in the United States to use placebo shams in a nontreatment control group to overcome the problem of what researchers at the time called "psychic influence." As such, it was an extremely important moment in the history of clinical trial design. Yet, as I argue, the Sanocrysin experiment also needs to be understood in terms of both the regulatory environment at the time and the commercial interests of Parke, Davis & Company, the pharmaceutical manufacturer that was intent on introducing the drug. Although some historians argue that therapeutic reformers in the twentieth century used experimental science to rein in the commercial forces of the market, this article suggests that, at least in this case, the promotion of rigorous clinical science and the pursuit of corporate profit were deeply intertwined.
本文详细分析了1926年进行的桑诺西辛临床试验的起源及意义。桑诺西辛是一种金化合物，当时被认为可用于治疗肺结核。该实验通常被视为美国首个使用正式随机系统将研究对象分为治疗组和非治疗组的临床试验；它可能也是美国首个在非治疗对照组中使用安慰剂来克服当时研究人员所称的“心理影响”问题的临床试验。因此，它是临床试验设计史上极其重要的时刻。然而，正如我所主张的，桑诺西辛实验还需要从当时的监管环境以及制药商帕克·戴维斯公司的商业利益角度来理解。该公司意图推出这种药物。尽管一些历史学家认为20世纪的治疗改革者利用实验科学来控制市场的商业力量，但本文表明，至少在这个案例中，严谨临床科学的推广与企业利润的追求紧密地交织在一起。
