10樁出現可怕差錯的臨牀試驗(上)

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.

臨牀試驗是新藥的上市之前非常重要的一步，這是FDA（美國食品藥品監督管理局）批准的前提，也是試驗藥物到底是否安全的標準。大多數時候，臨牀試驗是順利的，藥物也被批准廣泛使用。但總髮生那麼一兩次意外，臨牀試驗出現極大地差錯，造成可怕的後果。接下來就是10樁著名的出問題的臨牀試驗，醫藥公司恨不得把它們全部埋葬。

10 The Thalidomide Trials

10 沙利度胺試驗

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.

沙利度胺在德國首次量產，主要用於治療呼吸道感染。如今，更多人知道它是一種可以終止壬辰反應的藥。在19世紀60年代有10000名新生兒出現嚴重的損傷，例如缺少肢體和齶裂，就是因爲孕婦使用了該藥。

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.

不像本名單上的其他藥物，沙利度胺的臨牀試驗非常詭異，因爲結果完全沒問題，十分安全。在申請專利和頒發許可階段，研究員進行了動物實驗，但忽略了對它們後代的影響。由於該藥物不存在過量死亡的風險，所以人們覺得它安全性高，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年澳大利亞醫生威廉·麥克佈雷德才發現沙利度胺和畸形兒的關聯。但在此之前，所有的臨牀試驗得出的結論都是沙利度胺是安全的非處方藥——然而10000人爲之付出了代價。

9 French Biotrial Tragedy

9 法國藥物實驗室Biotrial的悲劇

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，法國公司Biotrial招募了128名健康志願者來參加一種新藥的臨牀試驗，這種藥用來對抗與癌症和帕金森病相關的焦慮症。在該藥小劑量的影響下，沒有發現病人有副作用。但在第一週增加劑量後，問題逐漸浮現了。最典型的是6個名參與者，病情嚴重，被直接送往急診。

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.

參加該試驗的兩週後，其中一名健康的快30歲的男性，在入院一週後就被宣佈腦死亡。其餘五人病情穩定，但是醫生預計他們會受到不可逆的大腦損傷和精神障礙。

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.

儘管這是該藥的第一次人體試驗，但在之前試驗主管就知道這個藥存在嚴重的問題。一家法國新聞披露，之前在狗身上的預實驗就發生嚴重的不良反應，導致許多狗死亡，其餘活下來的都有大腦損傷。但是這項試驗還是在人體上開展了，造成了如此可怕的結果。

8 The University of Minnesota Seroquel Experiment

8 明尼蘇達大學抗抑鬱藥斯瑞康試驗

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.

“我的兒子丹在5年前明尼蘇達大學的臨牀研究中死去了，這是一項沒有給出他任何診斷的研究，這是一項我花了5個月都沒能讓他退出的研究。”自從她兒子早逝後，瑪麗·維斯就一直在向世界傳遞這個事件。

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，她患有妄想症的兒子，丹·馬金森被診斷出精神分裂症，進入明尼蘇達大學醫療中心治療，位於費爾維尤。不久，他就被分到一組臨牀試驗中，該組測試3種治療精神分裂症的藥物：斯瑞康、維思通和再普樂。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.

對此，他的母親瘋狂地向研究中介寫信、發郵件、打電話，希望他們能讓她兒子退出這個項目。但是政府禁止丹退出該研究，還威脅他如果他再想終止，他們就把丹送進精神病院。維斯非常震驚，直到她發現了該研究的一個關鍵事實：他兒子的參與可以爲學校帶去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.

由於沒辦法離開研究，馬金森的妄想逐漸加重，最終他在浴室將自己刺死。自殺遺言寫着：“我笑着完成了這項實驗！”他的母親懷着極大地絕望起訴了學校，而學校拒絕承擔這份責任。共有五名研究對象嘗試自殺，有兩名自殺身亡，馬金森是其中一位。

7 Gene Therapy Clinical Trial

7 基因治療臨牀試驗

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歲的傑西·格爾辛基參加了一項基因治療安全性的研究，該治療針對患有嚴重肝臟基因變異的兒童。跟一起參加的其他孩子一樣，傑西患有先天性鳥氨酸甲酰氨基轉移酶（OTC）缺乏症，他的肝臟無法代謝足夠的血氨。研究人員嘗試通過注射感冒病毒來治療。但一劑高劑量的這種藥物就造成了傑西生命的終結。1999年9月17日，他的症狀迅速惡化，從黃疸發展爲器官衰竭，最後腦死亡。

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深入調查此案，發現在試驗管理部分存在嚴重不負責任的行爲。第一，格爾辛基是接受試驗的最後一組病人，而在之前的每一個組都發生了嚴重的副反應。然而，試驗還是繼續進行着。第二，格爾辛基的血氨水平非常高，本來一開始就不符合參加試驗的標準。他原本只是個替補，但有一個病人退出了，研究員就不加考慮地將他納入研究中。

6 Anil Potti's Miracle Cancer Drug

6 阿尼爾·波提的抗癌神藥

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.

整個20世紀，阿尼爾·波提是一顆冉冉升起的醫學明星。他保證癌症的治癒率可以達到80%，醫學專家們也相信他的發現每年都可以拯救10000人。但在2015年，一切都改變了；波提涉嫌在1部原稿、9篇論文和1次授權申請中使用虛假數據，所以他所有的研究結果都被視爲無效。

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，喬伊斯·索芙尼受到這場騙局的影響尤爲嚴重，她是波提2008年7月開展的試驗中的第一個病人。由於波提保證了癌症有80%的治癒率，患有乳腺癌的索芙尼急切地參加了這場研究。她經歷了痛苦的活檢，就是醫生通過一根長針，從手臂下扎入，一直向上到脖子出採集組織樣本。然後對她進行了阿黴素＋環磷酰胺（AC）的化療方案，2年後她才被告知這套研究方案由於波提的參與，試驗結果無效了。如今，雖然索芙尼不在患有乳腺癌，但由於該化療方案，導致了她罹患多發血栓及糖尿病，以及由本試驗本身造成的創傷後壓力心理障礙症（PTSD）。