10樁出現可怕差錯的臨牀試驗(下)

5 Stem Cell Vision Treatment

5 視神經幹細胞治療

In January 2017, three women entered a study with their vision and left without it. Their ages ranging from 72 to 88, all three of these women suffered from macular degeneration, an eye disease closely related to old age. The patients each paid $5,000 to have both eyes treated with stem cell therapy, a process that was "both atypical and unsafe" according to several ophthalmology experts.

2017年1月，3名女性在她們參與的研究中喪失了視力。她們的年齡在72-88之間，患有 黃斑部變性，是一種老年性疾病。她們每人都交了5000美元的治療費，接受了幹細胞療法，但據多個眼科專家所說，該療法“既不典型又不安全”。

Just days after the procedure, all three women reported severe side effects, including bleeding and retinal detachment. One patient entirely lost her eyesight, while the other two lost most. None of the patients are expected to recover their sight. But scientists knew that this trial had flaws from the beginning. First and foremost, the patients were required to pay for their own procedures, which is a flagrant sign of illegitimate research. Additionally, medical professionals have tried to erase the history of the trial; when you visit government records of the trial online, it only says that the study was "withdrawn prior to enrollment," which clearly was not the case.

就在治療幾天後，3名女性都出現嚴重的副作用，包括出血及視網膜脫落。其中一個病人完全喪失了視力，其餘兩人大部分視力受損。她們恢復視力的可能性幾乎沒有。但是科學家從一開始就知道該試驗存在缺陷，而且最重要的是，要求病人自費參與治療的試驗項目，通常都意味着是非法的。另外，醫學專家們竭力抹去了這場試驗的存在；如果你在網上查找該試驗的官方記錄，只會顯示“註冊前即取消”，但事實根本不是這樣！

4 Leukemia CAR-T Trial

4 白血病的，嵌合抗原受體T細胞免疫療法（CAR-T）

In July 2016, three adult leukemia patients died in a trial of a new cellular-level medicine. Nicknamed CAR-T, this new treatment option was supposed to attack the malignant cells until they appeared to have vanished. The technology was an up-and-coming phenomenon that many researchers called the "fifth pillar" of cancer treatment, but hopes were soon dashed by the results of the 2016 study.

2016年7月，3名成年白血病患者死於一場臨牀試驗，該實驗使用了一種新的細胞層面的藥物，叫做CAR-T（嵌合抗原受體T細胞免疫療法），新療法的治療理念是攻擊惡性細胞直到完全消滅它們。這項技術非常具有前景，許多研究員稱它爲癌症治療的“第五支柱”，但2016年的這場研究結果，徹底毀滅了治療希望。

The cause of death for the three patients was swelling in the brain, medically known as cerebral edema. Representatives from the sponsoring medical company Juno admit that cerebral edema is rather common in patients who have been given CAR-T treatments, as are immune system reactions and increased neurological toxicity.

3名病人的死因爲腦水腫。來自醫藥公司的贊助商——朱諾的代表們承認，在接受CAR-T治療的病人中，腦水腫的發生比較普遍，因爲是免疫系統的反應增加了神經毒性。

After the news of the deaths had been released, Juno's stock fell 27 percent. Their practices are currently under FDA review, and it is unclear whether they will be allowed to continue their studies.

在死亡事件曝光後，朱諾的股價跌了27%。他們的試驗正在被FDA重新審查，目前尚不清楚他們的研究是否還能進行。

3 New York Lidocaine Disaster

3 紐約利多卡因災難

In 1996, University of Rochester sophomore Nicole Wan needed some pocket money. So she decided to sign up, without her parents' permission, for a clinical trial that paid $150. The researchers inserted a tube down her throat and into her lungs to see the effects of pollution on her respiratory system, a common procedure called a bronchoscopy.

1996年，羅徹斯特大學的大二學生妮可·王需要一點零花錢，於是她瞞着父母參加了一場臨牀試驗，以賺取150美元。研究員從她的喉嚨插入一根管子，一直深入到肺部，以查看環境污染對她呼吸系統的影響，這是個很常見的步驟，叫做支氣管鏡檢。

But what Nicole did not know was that they took far more cell samples than originally outlined in the proposal. And as they took more samples from her lungs, they increased the dose of her anesthetic, Lidocaine, far above the levels approved by the FDA. She was released feeling incredibly weak and in enormous amounts of pain, and two days later was found dead. An autopsy revealed that lethal levels of Lidocaine, due to malpractice in the study, had caused her heart to stop beating and the rest of her body to fail along with it.

但是妮可不知道的是他們取了很多肺部細胞樣本，超出了一開始合同裏規定的量。並且在他們取樣的過程中，不停地增加對她使用利多卡因（一種局部麻醉劑）的劑量，遠遠大於FDA的安全劑量。她離開時非常虛弱，還承受着巨大的疼痛，在2天后，妮可就去世了。屍檢顯示體內殘留致死劑量的利多卡因。由於在此研究中的玩忽職守，才導致妮可心臟停跳，其他身體器官隨之衰竭。

2 John Hopkins Asthma Trial

2 約翰·霍普金斯醫院哮喘試驗

Ellen Roche, a technician at Johns Hopkins Hospital, volunteered to take part in an asthma trial for healthy individuals. The trial's goal was to discover what mechanism kept healthy people from developing the symptoms of asthma, so the doctors induced a mild asthmatic reaction and then treated it with hexamethonium.

艾倫·羅切是約翰·霍普金斯醫院的一名技術員，自願參加了一項針對健康人的哮喘試驗。該試驗的目的是找出健康人沒有發生哮喘的機制。於是醫生引發艾倫出現一點點哮喘的症狀，並用六甲銨來治療。

At first, inhaling this medicine simply caused Ms. Roche to develop a cough. But as time progressed, she was put on a ventilator as her lung tissue broke down and her kidneys began to fail. She died one month later, on June 2, 2001. Medical officials from the trial admit that the hexamethonium "was either solely responsible for the subject's illness or played an important contributory role." To make matters worse, participants learned after the trial that hexamethonium is not even an FDA-approved drug. This fact was not included in the consent form, so Johns Hopkins has been forced to take full responsibility for Roche's death.

一開始，吸入這種藥只讓羅切出現咳嗽症狀。但隨着時間的推移，她的肺組織遭到了破換，腎臟也出現了衰竭，不得不用呼吸機維持生命。她一個月後去世，就在2001年6月2號這一天。該試驗的醫學人員承認六甲銨“可能是導致研究對象生病的唯一因素，或至少在其中起了很大作用。”更糟糕的是，參與者事後才發現六甲銨根本不是FDA批准使用的藥物。這件事在知情同意書中根本沒有提到，所以，約翰·霍普金斯醫院對羅切的死應負全責。

1 The Elephant Man Trial

1 象人試驗

The most famous clinical trial of all time, the elephant man trial took place in London in 2006. The trial, which was testing a new cancer treatment called TGN1412, seemed harmless to the eight men who took part in it; medical professionals had assured them that the worst symptoms would only include a headache and nausea.

有史以來最出名的臨牀試驗，應該算是2006年發生在倫敦的象人試驗了。試驗是爲了檢驗一種叫TGN1412的新型抗癌藥，該藥看似對8個參與者沒什麼傷害；醫學專家保證最壞的副作用只會有頭疼和噁心。

But the results were much more gruesome than that. Shortly after they were given the doses, all of the patients began writhing in pain and vomiting. One of the participants lost his fingers and toes, while another had to have his foot partially amputated. The trial earned its nickname, "The Elephant Man Trial," because one participant's head swelled up so large that his girlfriend teased him about looking like an elephant.

但結果比這個可怕多了。給藥不久，所有的病人都因劇痛出現扭動，並開始嘔吐。其中一名參與者失去了他的手指和腳趾，另一個不得不把部分腳截肢。還有一個參與者的頭出現嚴重腫脹，被他的女朋友嘲笑像一隻大象，於是這個試驗就有了外號——象人試驗。

No one is completely sure what went wrong, but the patients have a few ideas. One suggests that the timing of the dosage made it dangerous; researchers spent 90 minutes slowly injecting animals with the drug, but took a mere six minutes to inject it into the human subjects. Another claims that the preliminary animal testing was inaccurate because instead of testing on a bonobo, whose DNA is a 98 percent match to humans, the agency cut costs and used a macaque, whose DNA is only a 94 percent match. These men may never know exactly what went wrong that fateful day, or how it will continue to affect their lives.

沒有人能確定出錯的原因，但參加的病人有幾點想法。一個認爲給藥的時間造就了危險；研究員給動物用藥時花了90分鐘緩慢注射，但在人這，只用了6分鐘就注射完了。另一位認爲之前的動物預試驗就是不準確的，因爲他們沒有用倭黑猩猩（DNA與人類有98%相似度）做試驗，爲了節省開支，研究機構使用了獼猴（DNA與人類僅有94%相似度）。這些人也許永遠都不會知道那悲劇的一天到底哪出了問題，也不會知道有沒有其他問題會繼續影響他們未來的人生。