Clinical trials are the most important step in getting a drug approved by the FDA, and without them, no one would know if their medicines were safe. The vast majority of the time, these trials go well, and the medicine is approved for general use. But every once in a while, a clinical trial goes horribly wrong. Keep reading to learn about ten of these famous incidents that medical companies try desperately to hide.
临床试验是新药的上市之前非常重要的一步，这是FDA（美国食品药品监督管理局）批准的前提，也是试验药物到底是否安全的标准。大多数时候，临床试验是顺利的，药物也被批准广泛使用。但总发生那么一两次意外，临床试验出现极大地差错，造成可怕的后果。接下来就是10桩著名的出问题的临床试验，医药公司恨不得把它们全部埋葬。
10 The Thalidomide Trials
10 沙利度胺试验
Thalidomide was first manufactured in Germany, primarily for the purpose of treating respiratory infections. Today, many people know about this drug because of its adverse effects on pregnancy. Over 10,000 children born during the 1960s suffered serious impairments, such as missing limbs and cleft palates, as a result of this drug.
沙利度胺在德国首次量产，主要用于治疗呼吸道感染。如今，更多人知道它是一种可以终止壬辰反应的药。在19世纪60年代有10000名新生儿出现严重的损伤，例如缺少肢体和腭裂，就是因为孕妇使用了该药。
Unlike the other trials on the list, the eerie part of the thalidomide clinical trial was that everything went horribly right. During the patenting and approval phase, researchers tested the drug on animals but neglected to observe the effects on their offspring. Since it was impossible to die from an overdose of the medicine, it was deemed safe, and it hit the shelves in 1956.
不像本名单上的其他药物，沙利度胺的临床试验非常诡异，因为结果完全没问题，十分安全。在申请专利和颁发许可阶段，研究员进行了动物实验，但忽略了对它们后代的影响。由于该药物不存在过量死亡的风险，所以人们觉得它安全性高，在1956年上架。
It was not until 1961 that Australian doctor William McBride discovered the link between Thalidomide and the deformities. But until then, every clinical trial came to the conclusion that thalidomide was a safe over-the-counter medicine—and 10,000 people paid the price.
直到1961年澳大利亚医生威廉·麦克布雷德才发现沙利度胺和畸形儿的关联。但在此之前，所有的临床试验得出的结论都是沙利度胺是安全的非处方药——然而10000人为之付出了代价。
9 French Biotrial Tragedy
9 法国药物实验室Biotrial的悲剧
In January 2016, the French company Biotrial recruited 128 healthy volunteers to take part in a clinical trial of a new drug designed to combat anxiety related to cancer and Parkinson's disease. Under the influence of small doses of the drug, the patients reported no side effects. But when the doses began to escalate after the first week, problems started to surface. In particular, six of the participants became sick and were immediately sent to the ER.
2016年1月，法国公司Biotrial招募了128名健康志愿者来参加一种新药的临床试验，这种药用来对抗与癌症和帕金森病相关的焦虑症。在该药小剂量的影响下，没有发现病人有副作用。但在第一周增加剂量后，问题逐渐浮现了。最典型的是6个名参与者，病情严重，被直接送往急诊。
One of these patients, a healthy man in his late 20s, was declared brain dead just one week after being admitted to the hospital and two weeks after starting the trial. The five other patients remained in a stable condition, but doctors predict that many will have suffered irreversible brain damage and mental handicaps.
参加该试验的两周后，其中一名健康的快30岁的男性，在入院一周后就被宣布脑死亡。其余五人病情稳定，但是医生预计他们会受到不可逆的大脑损伤和精神障碍。
Even though this was the first time the drug had been tested on humans, the trial administrators knew that there were serious issues with the drug. One French news source uncovered a pre-trial that had similar effects on dogs, killing several and leaving others with brain damage. Yet the trial was still conducted on humans, and with horrible results.
尽管这是该药的第一次人体试验，但在之前试验主管就知道这个药存在严重的问题。一家法国新闻披露，之前在狗身上的预实验就发生严重的不良反应，导致许多狗死亡，其余活下来的都有大脑损伤。但是这项试验还是在人体上开展了，造成了如此可怕的结果。
8 The University of Minnesota Seroquel Experiment
8 明尼苏达大学抗抑郁药斯瑞康试验
My son Dan died almost five years ago in a clinical study at the University of Minnesota, a study he lacked any diagnosis for, and a study that I tried unsuccessfully to get him out of for five months. Ever since her son's untimely death, Mary Weiss has been trying to spread this message to the world.
“我的儿子丹在5年前明尼苏达大学的临床研究中死去了，这是一项没有给出他任何诊断的研究，这是一项我花了5个月都没能让他退出的研究。”自从她儿子早逝后，玛丽·维斯就一直在向世界传递这个事件。
In 2003, her delusional son, Dan Markingson, was diagnosed with schizophrenia and admitted to the University of Minnesota Medical Center in Fairview. Shortly after, he was put into a clinical trial testing three different types of schizophrenia medications: Seroquel, Risperdal, and Zyprexa. But very quickly, his daily 800mg doses of Seroquel started to worsen his delusions.
2003年，她患有妄想症的儿子，丹·马金森被诊断出精神分裂症，进入明尼苏达大学医疗中心治疗，位于费尔维尤。不久，他就被分到一组临床试验中，该组测试3种治疗精神分裂症的药物：斯瑞康、维思通和再普乐。但是很快，他每天服用的800毫克斯瑞康加重了他的妄想症。
In response, his mother frantically sent letters, emails, and called the study coordinators to try and take her son out of the program. But the administration banned Dan from leaving the study, threatening to put him into a mental facility if he tried to drop out. Weiss was shocked by this until she learned a key fact about the program: her son's participation was worth $15,000 to the school.
对此，他的母亲疯狂地向研究中介写信、发邮件、打电话，希望他们能让她儿子退出这个项目。但是政府禁止丹退出该研究，还威胁他如果他再想终止，他们就把丹送进精神病院。维斯非常震惊，直到她发现了该研究的一个关键事实：他儿子的参与可以为学校带去15000美元的收益。
Unable to leave the program, Markingson's delusions became worse until he eventually committed suicide by stabbing himself to death in the shower. A suicide note read, "I went through this experience smiling!" Devastated, his mother sued the school, which refused to take responsibility for its actions. Markingson was one of five trial subjects to attempt suicide, and one of two who succeeded in taking their own lives.
由于没办法离开研究，马金森的妄想逐渐加重，最终他在浴室将自己刺死。自杀遗言写着：“我笑着完成了这项实验！”他的母亲怀着极大地绝望起诉了学校，而学校拒绝承担这份责任。共有五名研究对象尝试自杀，有两名自杀身亡，马金森是其中一位。
7 Gene Therapy Clinical Trial
7 基因治疗临床试验
Jesse Gelsinger was 18 when he entered a study that tested the safety of gene therapy in kids with severe genetic mutations in the liver. Like the other children in the study, he had been born with a condition called "OTC" that prevented his liver from eliminating enough ammonia, which the researchers tried to fight by injecting him with a cold virus. But one high dose of the medicine would be Gelsinger's last. On September 17, 1999, his symptoms quickly spiraled from jaundice, to organ failure, to brain death.
18岁的杰西·格尔辛基参加了一项基因治疗安全性的研究，该治疗针对患有严重肝脏基因变异的儿童。跟一起参加的其他孩子一样，杰西患有先天性鸟氨酸甲酰氨基转移酶（OTC）缺乏症，他的肝脏无法代谢足够的血氨。研究人员尝试通过注射感冒病毒来治疗。但一剂高剂量的这种药物就造成了杰西生命的终结。1999年9月17日，他的症状迅速恶化，从黄疸发展为器官衰竭，最后脑死亡。
The FDA dug into this death and found a few eerily irresponsible actions on the part of the administrators. For one, Gelsinger was in the final group of patients, and every group before him had suffered severe reactions to the drug. Yet the study continued. And secondly, Gelsinger's levels of ammonia were so high that they should have disqualified him from the trial in the first place; he was originally intended as an alternate, but a patient dropped out, and he was hastily included in the study.
FDA深入调查此案，发现在试验管理部分存在严重不负责任的行为。第一，格尔辛基是接受试验的最后一组病人，而在之前的每一个组都发生了严重的副反应。然而，试验还是继续进行着。第二，格尔辛基的血氨水平非常高，本来一开始就不符合参加试验的标准。他原本只是个替补，但有一个病人退出了，研究员就不加考虑地将他纳入研究中。
6 Anil Potti's Miracle Cancer Drug
6 阿尼尔·波提的抗癌神药
Throughout the 2000s, Anil Potti was an up-and-coming medical star. He promised cancer treatments with an 80 percent cure rate, and medical professionals believed that his discoveries could save 10,000 lives a year. But in 2015, this all changed; Potti was found guilty of including false data in a manuscript, nine papers, and a grant application, so the results of his studies were voided.
整个20世纪，阿尼尔·波提是一颗冉冉升起的医学明星。他保证癌症的治愈率可以达到80%，医学专家们也相信他的发现每年都可以拯救10000人。但在2015年，一切都改变了；波提涉嫌在1部原稿、9篇论文和1次授权申请中使用虚假数据，所以他所有的研究结果都被视为无效。
One woman who was particularly affected by this fraudulence was Joyce Shoffner, patient No. 1 in a July 2008 trial done by Potti. Under the guarantee that Potti's therapy cured 80 percent of cancers, Shoffner eagerly signed up to join the study to help cure her breast cancer. She underwent a painful biopsy, in which doctors took tissue samples by inserting a long needle from under her arm and up into her neck. She then went through a regimen of Adriamycin-Cytoxan (AC) chemotherapy, only to be told two years later that the study's results had been voided due to Potti's involvement. Today, Shoffner does not have breast cancer, but she lives with the blood clots and diabetes caused by the AC regimen, as well as post-traumatic stress disorder resulting from the trial itself.
其中，乔伊斯·索芙尼受到这场骗局的影响尤为严重，她是波提2008年7月开展的试验中的第一个病人。由于波提保证了癌症有80%的治愈率，患有乳腺癌的索芙尼急切地参加了这场研究。她经历了痛苦的活检，就是医生通过一根长针，从手臂下扎入，一直向上到脖子出采集组织样本。然后对她进行了阿霉素＋环磷酰胺（AC）的化疗方案，2年后她才被告知这套研究方案由于波提的参与，试验结果无效了。如今，虽然索芙尼不在患有乳腺癌，但由于该化疗方案，导致了她罹患多发血栓及糖尿病，以及由本试验本身造成的创伤后压力心理障碍症（PTSD）。
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