Faye's Neverland

之前某文提過黑人覺得毒品是米國政府幕後策劃，將毒品賣給黑人使用，企圖要讓他們的身體、心理都不健康的集體妄想，濫觴雖不見得完全來自以下的歷史，但黑人族群每每提及此事仍多義憤填膺，而在大部分的臨床試驗中，黑人的參與度明顯偏低，仍有『我不相信你們會對我好』的意思在裡頭；患者與臨床研究人員的信任，也遭受很大的打擊，被認為要醫治疾病、減少痛苦的醫師，挾著對知識的傲慢，罔顧病患的痛苦，一意孤行。我很難理解這種事的發生，尤其是在講求人權的米國，似乎制度的發展，都免不了要建立在或多或少的痛苦經驗上。

以下的英文是我的讀書報告，簡單摘要內容：1932~1972年間，米國公共衛生服務的性病研究人員，在阿拉巴馬州的Tuskegee村落進行關於梅毒的臨床進程及治療效果的研究，參與研究的個案為399個感染梅毒的黑人男性，及200名未感染梅毒的男性作為對照組，研究人員並未告訴個案關於診斷、可行的治療方式、及實驗進行的方式，參與實驗的個案可以獲得食物及『治療』。1932年，梅毒仍無有效的治療藥物，可用的藥物也有很大的副作用。1947年，盤尼西林被證實是有效的梅毒治療藥物，然而Tuskegee的研究人員隱藏這個訊息，個案並沒有獲得適當的『治療』或控制，研究人員將此研究視為『長期的觀察性研究，藉以瞭解梅毒的自然病程』。1966年，Peter Buxtun向主管機關提出停止該不人道研究的繼續進行，但未獲重視；1972年，Peter Buxtun向媒體披露此事，並成為報紙頭條封面故事，此研究被迫結束。1997年，柯林頓總統公開向受試的個案及家庭成員道歉。

也聽過這種說法，當時醫師未將盤尼西林使用在患者身上，原因是因為盤尼西林是針對第一、二期的梅毒的治療，症狀以生殖器（1st stage)或全身性（2nd Stage)的皮膚丘疹、紅斑為主，而Tuskegee的患者多半已進入第三期潛伏期或第四期神經性梅毒的階段，所以在無明確有效證據的情況下，而決定不採取盤尼西林的治療。我不是很贊成這種說法，醫者雖然比其他人更具有疾病及治療的知識，但並不表示可以代替他人決定該接受或不該接受治療，或者接受怎樣的治療，生命的主權要回歸到身體的主人手裡，病人不懂，就要想辦法說到他懂為止。

  The Tuskegee Syphilis Study is the steppingstone for looking up the ethic issue with human participants in clinical studies.

  In 1932, little was known about syphilis, which was more prevalent in low socioeconomic black community and usually progressed into long term, multisystemic disease. The Tuskegee Syphilis Study was conducted to understand the treatment and natural course of syphilis around Tuskegee Alabama. 399 participants and 200 controls were included; all of them were black Male, with little education, having no idea about their diagnosis and what was going in the study. The researchers went on this study without informed consent and withheld available treatment and substantial information from those participants.

By 1947, penicillin was proved as the standard treatment of syphilis; the Tuskegee researchers neither stopped the study nor gave treatment to the patients, they continued the no-treatment observational study to see the natural course of syphilis. Many people died and their wives were infected without proper management and information during the period. In 1966, Peter Buxtun, a public health service venereal disease investigator in San Francisco, made efforts to stop such unethical study in official way, but the study kept going on. In 1972, Peter Buxtun turned to the press, and the story became the front page on Washington Star and the New York Times, the study ended under the public outcry. (wikipedia: Tuskegee syphilis study)

In the first beginning of the Tuskegee study, there was less knowledge of syphilis and treatment efficacy was poor with severe side effects; the medical ethics were also vague without any executive standard. It could be understandable that the study started so rudely. However, some changes should be made along the available treatment and different moral standard was established. The Tuskegee Syphilis Study brings our attention to the morality of clinical studies involving human subjects. “In 1974, the National Research Act established the National Commission for protection of Human Subjects of Biomedical and Behavioral Research, which issued reports and recommendations identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and recommending guidelines to ensure that research is conducted in accordance with those principles” (IRB Guidebook: Introduction).  In 1978, the Belmont Report which set up the basic ethical principles in conducting researches involving human subject was submitted; those principles are respect for persons, beneficence, and justice. In the following days, the associated departments (DHHS, FDA) revised the details of IRB review and put them into federal regulations.

“We face a challenge in our time. Science and technology are rapidly changing our lives with promise of us much healthier, much more productive and more prosperous. But with these changes we must work harder to see that as we advance we don’t leave behind our conscience. No ground is gained and, indeed, much is lost if we lose our moral bearings in the name of progress” (President Bill Clinton’s remark in apology for study done is Tuskegee on May 16, 1997).