Brawley O W
Office of Special Populations Research, National Cancer Institute, Bethesda, MD 20892, USA.
Int J Radiat Oncol Biol Phys. 1998 Jan 1;40(1):5-8. doi: 10.1016/s0360-3016(97)00835-3.
The participation of minorities in clinical studies is the subject of much discussion and has even become the subject of Federal law. The project known as the Tuskegee Syphilis Study and officially titled "The Tuskegee Study of Untreated Syphilis in the Negro Male," is one of the great debacles of American medicine and a national shame. Despite the fact that its existence is well known, many do not know the historical facts of the study nor the context of the study. My purpose here is to recount the facts of the study and its historical context.
The history recounted here is taken from documents gathered during a U.S. Senate investigation of the study, original papers located in National Library of Medicine, and books about the trial.
The trial began in 1931 as a survey of the natural history of untreated tertiary syphilis in Black men. This study enrolled 399 men with syphilis and 201 uninfected men to serve as controls. All were at least 25 years old at enrollment. The men were told they were in a study, but never educated about the implications. Later, men were not informed that there was a treatment for effective treatment for their disease--a treatment that was being withheld from them. This trial continued till 1972.
Many of the issues that led to the study and caused it to continue for 40 years still exist. The lessons of the Public Health Study of Untreated Syphilis in the Untreated Negro include the dangers of paternalism, arrogance, blind loyalty, and misuse of science. "Those who do not appreciate history are condemned to repeat it" (Alfred North Whitehead).
少数群体参与临床研究是一个备受讨论的话题,甚至已成为联邦法律的主题。名为塔斯基吉梅毒研究、官方标题为“塔斯基吉黑人男性未经治疗的梅毒研究”的项目,是美国医学史上的重大失败之一,也是国家的耻辱。尽管其存在广为人知,但许多人并不了解该研究的历史事实及其背景。我在此的目的是讲述该研究的事实及其历史背景。
此处讲述的历史取自美国参议院对该研究进行调查期间收集的文件、国立医学图书馆中的原始论文以及关于该试验的书籍。
该试验始于1931年,是对黑人男性未经治疗的三期梅毒自然史的一项调查。这项研究招募了399名患有梅毒的男性和201名未感染的男性作为对照。所有参与者在入组时至少25岁。这些男性被告知他们参与了一项研究,但从未被告知其影响。后来,这些男性未被告知他们的疾病有有效的治疗方法——而这种治疗方法被隐瞒了。该试验一直持续到1972年。
导致该研究并使其持续40年的许多问题仍然存在。未经治疗的黑人梅毒公共卫生研究的教训包括家长式作风、傲慢、盲目忠诚和科学滥用的危险。“不了解历史的人注定会重蹈覆辙”(阿尔弗雷德·诺思·怀特海)。