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KatherineEban_2020P-_关于仿制药的一剂现实真相_-
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| In 2008, I got an unusual phone call from a guy named Joe Graedon. |
2008 年,我接到了 一通不同寻常的电话 是一个叫乔 · 格莱登 （Joe Graedon）的人打来的。 |
| Joe said he was getting flooded with complaints from patients who had recently been switched to generic drugs. |
乔说,最近他收到了大量的投诉 来自近期改服仿制药的患者们。 |
| Joe was a trained pharmacologist and cohost of a radio show on NPR. |
乔是一位训练有素的药剂师, 同时,也搭档主持全国公共广播电台 （NPR）的一档电台节目。 |
| Patient after patient said their generics were causing unwelcome side effects or even relapses . |
一位又一位病人抱怨说, 仿制药带来了许多不良副作用, 甚至导致病情复发。 |
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complaints:n.不满;抱怨;投诉;控告;(complaint的复数) patients:n.接受治疗者,病人;(patient的复数) recently:adv.最近;新近; generic:adj.类的;一般的;属的;非商标的; pharmacologist:n.药理学家; cohost:主持人; generics:n.非专利药物;通用术语(generic的复数); unwelcome:adj.不受欢迎的;讨厌的;不被接受的;vt.冷淡地对待;n.冷淡; relapses:vi.故态复萌;旧病复发;再度堕落;再陷邪道;n.复发,再发;故态复萌;回复原状;
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| Joe believed the patients' claims . |
乔相信了病人的说法。 |
| But when he reported these complaints to the FDA, officials there argued, "It was probably psychosomatic . |
但当他把这些投诉上报给 美国食物及药品管理局（FDA）时, 那里的官员辩解说, “可能只是心理作用。 |
| Patients are upset by pills that look different from their old ones." |
药片的样子和以前的不同, 病人因此觉得不满。” |
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claims:v.宣称; n.声明; (claim的第三人称单数和复数) psychosomatic:adj.身心的;身心失调的;身心治疗的;n.身心上有病的人; upset:adj.沮丧; v.打乱; n.苦恼; (意外的)混乱; pills:n.药丸; v.起球; (pill的第三人称单数和复数)
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| Joe didn't buy it. |
乔没有买账。 |
| He wanted someone with investigative firepower to dig into this, and since I was an investigative journalist , he called me. |
他想请有调查火力的人 深挖这个情况, 因为我是一名调查记者, 他便联系了我。 |
| And then he posed a question that I couldn't get out of my head: "Katherine, what is wrong with the drugs?" |
然后他提出了一个问题, 一个在我脑海里挥之不去的问题: “凯瑟琳,这些药出了什么问题？” |
| I spent the next 10 years trying to track down the answer. |
接下来的十年里, 我试图追踪这个问题的答案。 |
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investigative:adj.研究的;调查的;好调查的; firepower:n.火力; journalist:n.新闻工作者;报人;记日志者; posed:v.造成;引起;产生;提问;质询;摆好姿势;(pose的过去分词和过去式) track:n.小道;足迹;车辙;轨道;v.追踪;跟踪;
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| Our health care system relies on generics. |
我们的医疗系统依赖仿制药。 |
| My family does, too. |
我的家人也是如此。 |
| But a decade of interviews , meetings with whistleblowers , on-the-ground reporting across four continents and thousands of confidential files -- from the FDA, from generic drug companies and from the courts -- all pointed me in the same direction: a large number of generic drug manufacturers in certain overseas countries are passing off substandard drugs as legitimate generics for profit . |
但经过十年的采访, 与知情者的会面, 跨越四大洲的实地探访, 以及数千份来自—— 美国食物及药品管理局, 来自仿制药公司, 以及来自法庭的机密文件—— 都将我指向了同一个方向: 在某些海外国家的 许多仿制药生产商 在把假冒伪劣的药品 伪装成合法仿制药出售 以攫取利润。 |
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health care:n.卫生保健; relies:信任; interviews:n.面试; v.对(某人)进行面试(或面谈); whistleblowers:告发者;检举者; on-the-ground:秘密的; continents:n.[地理]大陆,大洲(continent复数); confidential:adj.机密的;表示信任的;获信任的; manufacturers:n.生产者;制造者;生产商;(manufacturer的复数) overseas:adv.在海外,海外;adj.海外的,国外的; substandard:adj.不合规格的;标准以下的; legitimate:adj.合法的;正当的;合理的;正统的;v.使合法;认为正当(等于legitimize); profit:n.利润;利益;v.获利;有益;
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| They are deliberately flouting FDA regulations and standards . |
他们公然无视了 药监局的规章和标准。 |
| Basically , they are committing fraud . |
本质上说,他们犯了欺诈罪。 |
| In the process , they are risking the health of patients around the world. |
在这个过程中,他们让世界各地 患者的健康遭受威胁, |
| They may even be costing patient lives. |
甚至有可能危及患者的生命。 |
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deliberately:adv.故意地;谨慎地;慎重地; flouting:v.公然藐视,无视(法律等);(flout的现在分词) regulations:n.章程;规则;法规;管理,控制;(regulation的复数) standards:n.标准,水平,规格(standard的复数) Basically:adv.主要地,基本上; committing:v.做出;犯罪或错等;自杀;承诺,保证;(commit的现在分词) fraud:n.欺骗;骗子;诡计; process:v.处理;加工;列队行进;n.过程,进行;方法,adj.经过特殊加工(或处理)的;
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| One leading company in India has already shut down because of this activity. |
印度有一家大型制药厂就 已经因为这些行为关闭。 |
| I wanted to know, was that company an outlier or the tip of the iceberg ? |
我想知道, 那家公司是个例, 还是冰山一角？ |
| What I uncovered is disquieting , and anyone who takes generic drugs has the right to be deeply concerned . |
我的发现令人不安。 任何服用仿制药的人 都有权对此深表忧虑。 |
| If you're skeptical about any of this, that's fair. |
如果你对我说的任何事表示怀疑, 那都是情有可原的。 |
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outlier:n.[分化]异常值;露宿者;局外人;离开本体的部分; tip of the iceberg:冰山一角;事物的表面部分; uncovered:adj.裸露的; v.揭开盖子; (uncover的过去式和过去分词) disquieting:adj.令人不安的;使人忧虑的;v.使担心;使焦急;(disquiet的现在分词) concerned:adj.有关的;关心的;v.关心;与…有关;(concern的过去时和过去分词) skeptical:adj.怀疑的;怀疑论的,不可知论的;
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| I saw generics as one of the world's great public health innovations , a giant win for patients worldwide . |
我认为仿制药是世界上 非常伟大的公共医疗创举, 是对全球患者的巨大胜利。 |
| Ninety percent of our drugs today are generic. |
今天,我们 90% 的药物是仿制药。 |
| I knew generic HIV/AIDS medicine had saved many lives in Africa. |
我知道非专利的艾滋病药物 在非洲拯救了无数生命。 |
| Here at home, programs from Medicare to Medicaid and the Affordable Care Act depended on them. |
在美国, 联邦医疗保险（Medicare）、 医疗补助（Medicaid） 都要依靠仿制药。 |
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innovations:n.创新(innovation的复数);改革; giant:n.巨人;伟人;巨兽;adj.巨大的;特大的 worldwide:adj.全世界的;adv.在世界各地; Medicare:n.(美,加)医疗保险(等于medicare); Medicaid:n.(美)医疗补助计划; Affordable:adj.负担得起的;
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| In an overpriced drug market, generics were the heroic underdog . |
在定价过高的药品市场中, 仿制药可谓是失败的英雄。 |
| But my biggest assumption was based on the FDA's reassurance that properly regulated generic drugs are not only safe and effective , but bioequivalent, interchangeable with the brand and with one another. |
但我最大的假设是 基于美国药监局的保证, 即正确监管的仿制药 不仅安全有效, 还具有生物等效性, 和品牌药以及其他 仿制药能够互换使用。 |
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overpriced:adj.价格太高的;过于昂贵的 heroic:adj.英雄的;英勇的;记叙英雄及其事迹的;夸张的;n.史诗;英勇行为; underdog:n.比赛中不被看好者;失败者;受压迫者;斗败了的狗; assumption:n.假定;设想;担任;采取; reassurance:n.使安心,再保证; regulated:v.约束,控制,管理;(regulate的过去式和过去分词) effective:adj.有效的,起作用的;实际的,实在的;给人深刻印象; interchangeable:adj.可互换的;可交换的;可交替的; brand:v.铭刻于,铭记;打烙印于;印…商标于;n.商标,牌子;烙印;
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| Well, that's true -- if companies follow the rules on paper. |
好,这点确实没错—— 前提是公司遵守了明文规定。 |
| But inside far-flung drug plants, |
但在遥远的药厂里, |
| I uncovered a different, unwritten set of rules. |
我发现了一套 不同的、不成文的规定。 |
| I started my investigation by focusing on the regulatory framework. |
刚开始调查时, 我的注意力在监管框架上。 |
| Right away , one fact surprised me: the FDA does not vet manufacturer applications by testing the drugs. |
很快,有了一个另外吃惊的事实: 美国食物及药品管理局 筛查药物制造商的申请 |
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far-flung:adj.遥远的;广泛的;广布的; unwritten:adj.不成文的;口头的;没有记录的; regulatory:adj.管理的;控制的;调整的; Right away:立刻; vet:n.兽医;兽医诊所;v.审查;仔细检查,审查(内容、质量等);
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| Instead, it reviews company data. |
而是对公司数据的审核。 |
| As the FDA's generic drugs director actually told me, "The approval system requires the ethical behavior of the applicant . |
正如美国药监局 仿制药的主任告诉我的, “许可系统需要申请者的行为 合乎伦理道德规范。 |
| Otherwise, the whole house of cards will fall down." |
否则,整个系统都会崩塌。” |
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reviews:n.综述; v.回顾; approval:n.批准;认可;赞成; ethical:adj.伦理的;道德的;凭处方出售的;n.处方药; applicant:n.申请人(尤指求职、进高等学校等); house of cards:n.不可靠的计划;摇摇欲坠的组织;用纸牌搭成的房子;
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| Really? |
真的？ |
| It's the honor system ? |
仅仅依靠自觉吗？ |
| (Laughter) |
（笑声） |
| After nine months of digging, I published my first article on generics. |
经过九个月的调查, 我发表了第一篇关于仿制药的文章。 |
| I wrote about patients who'd been switched to generic drugs and suffered medical setbacks . |
我讲述了改服仿制药的患者 如何遭受了病情恶化。 |
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honor system:n.诚信制度(信赖人能自动守规则的制度); setbacks:n.挫折;周折(setback复数);
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| I quoted doctors who questioned whether generics really were bioequivalent to the brand. |
我引述了医生们的话, 他们质疑仿制药是否真的 具有与品牌药等同的生物等效性。 |
| A month later, I got an anonymous email from someone calling himself "Four Dollar Refill ." |
一个月之后, 我收到了一封匿名邮件 发件人自称 “四美元续药” 。 |
| (Laughter) |
（笑声） |
| Four dollars is what you'd pay to fill a generic prescription at Walmart . |
四美元是你在沃尔玛 购买仿制处方药的价格。 |
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quoted:v.引用;引述;举例说明;开价;(quote的过去分词和过去式) anonymous:adj.匿名的,无名的;无个性特征的; Refill:v.再装满;重新装满;n.又一份同种饮料;补充装材料; prescription:n.处方;药方;医生开的药;开处方; Walmart:n.沃尔玛(世界连锁零售企业);
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| Four Dollar Refill worked inside the generic drug industry. |
“四美元续药” 在仿制药行业内工作。 |
| He said if I really wanted to uncover the problem, |
他说,如果我真的想 调查这个问题的真相, |
| I'd better go look where the majority of our generic drugs are made: in India and China. |
我最好应该去看看 大部分仿制药被生产的地方: 印度和中国。 |
| Four Dollar Refill was right; 80 percent of the plants making the active ingredient for all our drugs, brand or generic, are overseas, mostly in China and India. |
“四美元续药” 是对的; 制造我们所有的药物, 包括品牌药和仿制药的 活性成分的工厂 有 80% 都位于海外, 主要在中国和印度。 |
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majority:n.大部分:大多数:多数票:成年人: ingredient:n.原料;要素;组成部分;adj.构成组成部分的;
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| Any generic drug company anywhere in the world wanting approval to sell its drugs into our market has to follow elaborate rules known as "Good Manufacturing Practices." |
在世界任何地方的任何仿制药公司 若是想得到向我们市场 出售其药物的许可, 都必须遵守一套被称为 《良好生产规范》的详尽法规。 |
| I decided to learn every detail of how to manufacture a legitimate generic drug. |
我决定去学习 如何生产合法仿制药的每一点细节。 |
| At a top New Jersey lab, |
在新泽西一间顶尖实验室, |
| I watched as technicians ran tests on specialized machines and used flasks that mimic stomach conditions to measure drug dissolution . |
我看着技术员在专业机器上进行测试, 用模仿胃部条件的烧瓶 测量药物的溶解过程。 |
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elaborate:adj.精心制作的;详尽的;煞费苦心的;v.精心制作;详细描述;变复杂; Manufacturing:n.制造业;工业;v.制造;生产(manufacture的现在分词); technicians:n.[劳经]技术员(technician的复数);工作人员; specialized:adj.专业的; v.专门研究(或从事); (specialize的过去式和过去分词) flasks:n.[分化]烧瓶;长颈瓶,细颈瓶;酒瓶,携带瓶; mimic:vt.模仿,摹拟;n.效颦者,模仿者;仿制品;小丑;adj.模仿的,模拟的;假装的; dissolution:n.分解,溶解;(议会等的)解散;(契约等的)解除;死亡;
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| But one remarkable fact jumped out. |
但有一个细节引起了我的注意。 |
| The lab banned Wite-Out -- correction fluid -- across its facility . |
这间实验室—— 在所有设施中 禁用了涂改液。 |
| Under FDA rules, data serves as the cornerstone of quality. |
在药监局的规章下, 数据是质量的基石。 |
| It has to be gathered at each manufacturing step, preserved and shared with regulators . |
在生产的每一步骤都必须收集、 保管数据, 并将其与监管者分享。 |
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remarkable:adj.卓越的;非凡的;值得注意的; banned:v.明令禁止;取缔;禁止(某人)做某事;(ban的过去分词和过去式) correction fluid:n.涂改液;修正液; facility:n.设施;设备;特别装置;特色;场所;天资; cornerstone:n.基础;柱石;地基; preserved:v.保护;维护;保留;保存;保养;(preserve的过去式和过去分词) regulators:n.调整者;调节阀(regulator的复数形式);
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| Wite-Out was high-risk . |
涂改液会带来很大风险。 |
| It invited tampering . |
它会引诱人篡改数据。 |
| It was clear that for the FDA's regulatory regime to succeed, any company applying for approval had to be ethical, and its data had to be unaltered . |
很明确的是, 药监局的监管制度想要成功实施, 任何申请许可的公司 都必须遵守伦理道德规范, 且其数据必须是未经改动的。 |
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high-risk:adj.高危险度的; tampering:v.干预;篡改;(tamper的现在分词) regime:n.政权,政体;社会制度;管理体制; applying:v.申请,请求;使用;应用;(apply的现在分词) unaltered:adj.不变的;未被改变的;照旧的;
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| But what if neither was true? |
但要是两者都被违反了呢？ |
| What if the applicant was not ethical? |
要是申请者并不道德？ |
| What if the data was not pristine ? |
要是数据并非原始版本？ |
| I started to hear about a company in India called Ranbaxy, |
我开始听说一家位于印度叫 兰伯西（Ranbaxy）的公司, |
| India's largest drug company, one of its first successful multinationals and one of the fastest-growing generic suppliers to the US market. |
它是印度最大的制药公司, 是印度首批成功的跨国公司, 也是美国市场中增长 最快的仿制药供应商。[07:37] |
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what if:如果…怎么办? pristine:adj.原始的,古时的;纯朴的; multinationals:n.跨国公司(multinational的复数);
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| A whistleblower was supplying internal Ranbaxy documents to the FDA. |
一位知情者把兰伯西的内部文件 提供给了美国药监局, |
| I got copies. |
我也得到了这些文件的副本。 |
| Deciphering the company's charts, graphs and numbers unveiled a shocking swindle . |
解读了这家公司的图表和数据后, 我揭开了一个令人震惊的骗局。 |
| They substituted unapproved , lower-purity ingredients . |
他们替换了未经批准的、 低纯度的原料。 |
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internal:n.内脏;本质;adj.内部的;里面的;体内的;(机构)内部的; Deciphering:n.[通信]解密;v.破译(decipher的现在分词);解释;辨认; unveiled:adj.裸露的;公布于众的;v.公开(unveile的过去分词);原形毕露; swindle:n.欺诈;骗局;vt.诈骗;骗取;vi.诈骗; substituted:adj.取代的,代替的;v.代替;用…代替(substitute的过去式); unapproved:adj.未经批准的;未经同意的;未经承认的; ingredients:n.成分;(尤指烹饪)原料;(成功的)要素;(ingredient的复数)
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| They invented documents like standard operating procedures , steaming them overnight in a sauna-like room to make them look old. |
他们编造出类似 标准操作流程的文件, 在桑拿房一样的房间中 连夜干蒸这些文件, 让它们看上去像用旧了一样。 |
| They conjured up three-, six-, nine- and 18-month stability studies, all generated on the same day. |
他们捏造出 3 个月、6 个月、 9 个月和 18 个月的稳定性研究, 结果全都是在同一天生成的。 |
| Gradually , I was able to unearth the story behind this regulatory nightmare . |
渐渐地,我得以发掘出 这场监管噩梦背后的故事。 |
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procedures:n.程序;规程(procedure的复数); overnight:adj.夜间的; v.在夜间; n.(美)前一天的晚上; conjured:v.变魔术;变戏法(conjure的过去分词和过去式) stability:n.稳定性;坚定,恒心; generated:v.产生;引起;(generate的过去式和过去分词) Gradually:adv.渐渐地;逐步地; unearth:vt.发掘;揭露,发现;从洞中赶出; nightmare:n.恶梦;梦魇般的经历;adj.可怕的;噩梦似的;
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| In 2004, Ranbaxy hired a new research and development director. |
2004 年,兰伯西雇佣了 一位新的研发部主任。 |
| He suspected something was amiss . |
他嗅到了猫腻, |
| He ordered a young engineer named Dinesh Thakur to study the data in every drug application to find out if it was real or fake . |
于是便委任一位名叫迪内西·塔库尔 （Dinesh Thakur）的年轻工程师 研究每一份药物申请中的数据, 辨别数据的真伪。 |
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research and development:n.研究和开发; suspected:v.怀疑;不信任;(suspect的过去分词和过去式) amiss:adj.有毛病的,有缺陷的;出差错的;adv.错误地; application:n.应用;申请;应用程序;敷用; fake:n.假货;骗子;假动作;v.捏造;假装…的样子;adj.伪造的;
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| Thakur eventually put together a devastating PowerPoint showing Ranbaxy had falsified data for over 200 products in more than 40 countries. |
塔库尔最后整理出 一份骇人听闻的 PPT 演示, 表明兰伯西在 200 多件 产品中伪造了数据, 波及 40 多个国家。 |
| The new R and D director showed this PowerPoint to a subcommittee of the board of directors. |
新任研发部主任把这份演示 拿给一个隶属董事会的委员会看。 |
| The subcommittee ordered the report and the laptop on which it was created destroyed. |
这个委员会下令对这份报告, 以及编写报告所用的手提电脑 进行销毁。 |
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eventually:adv.最后,终于; put together:..放在一起;组合;装配; devastating:adj.毁灭性的; v.毁灭; (devastate的现在分词) falsified:v.篡改,伪造;(falsify的过去分词和过去式) subcommittee:n.小组委员会;委员会的附属委员会; laptop:n.便携式电脑;笔记本电脑;
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| Then they forced Thakur out of the company. |
然后他们强行把塔库尔开除了。 |
| Thakur couldn't sleep, thinking about Ranbaxy's perilously bad drugs. |
塔库尔夜不能寐, 满脑子都是兰伯西 充满危险的伪劣药物。 |
| So he risked his life to alert the FDA. |
于是他冒着生命危险, 向美国药监局发出了警报。 |
| After an eight-year investigation, Ranbaxy pled guilty to seven felonies for faking data. |
经过一场为期八年的调查, 兰伯西承认了七项 伪造数据的重罪。 |
| An FDA consultant taught me that just like cheap clothing made in distant factories, or "fast fashion," as she called it, there were fast drugs, too, made in pharmaceutical sweatshops overseas with low-quality ingredients and manufacturing shortcuts . |
一位药监局的顾问告诉我, 就像在遥远工厂中 生产的廉价服装一样, 她将其称之为 “快餐时装” , 也有 “快餐药物” , 是在海外制药业的血汗工厂里, 用劣质原料和生产 “捷径” 制造的。 |
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perilously:adv.危机四伏地;充满危险地; alert:n.警报; adj.警觉的; v.向…报警; pled:v.辩护;恳求(plead的过去式和过去分词); guilty:adj.有罪的;内疚的; felonies:n.重罪; faking:v.伪造;冒充;假装,佯装,装出;(fake的现在分词) consultant:n.顾问;高级顾问医师;会诊医师; distant:adj.遥远的;远处的;久远的; pharmaceutical:adj.制药(学)的;n.药物; sweatshops:n.血汗工厂;剥削劳力的工厂(sweatshop的复数); shortcuts:n.近路;捷径;快捷方式(图标);(shortcut的复数)
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| In Mexico City, I sat in a bar with a whistleblower. |
在墨西哥城, 我和一位知情者在酒吧里碰面。 |
| He handed me documents revealing how the cost-cutting generic drug plant where he worked had knowingly released drug batches that contained glass particles . |
他递给我的文件中揭露了他所工作的 削减成本的仿制药工厂 是如何在知情的情况下释出了 含有玻璃颗粒的药物批次。 |
| In Accra, capital of Ghana, doctors explained how low-cost Indian and Chinese medicine of all kinds barely seemed to work, even when they doubled and tripled the doses . |
在加纳的首都阿克拉, 医生们解释说, 各种廉价的印度和中国药物 几乎完全没效, 即使剂量已经翻了两倍或三倍。 |
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revealing:adj.暴露的;发人深省的;v.揭示;露出;显示;展示;(reveal的现在分词) cost-cutting:n.削减成本;v.削减成本(cost-cut的现在分词); knowingly:adv.故意地;机警地,狡黠地; released:v.释放;使免除;已发布;(release的过去分词和过去式) batches:一批(batch的名词复数); particles:n.微粒,粒子;粒子系统;碎木料(particle的复数形式); low-cost:adj.廉价的;价格便宜的; barely:adv.仅仅,勉强;几乎不;公开地;贫乏地; tripled:adj.三倍的;三方的;n.三倍数;三个一组;vi.增至三倍;vt.使成三倍; doses:v.服药(dose的三单形式);n.[药][核]剂量(dose的复数);
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| In Mumbai, I met another whistleblower from a company that I had believed was ethical. |
在孟买,我见了另一位知情者, 他来自一个我曾以为 遵守道德规范的公司。 |
| He sat there and described the well-oiled machinery of data manipulation his company used to get compromised drugs approved fast. |
他坐在那里描述了 自己的公司如何熟练地运作 数据操纵的机制, 以便让有问题的药物能快速过审。 |
| With tears running down his cheeks, he said, "What's going on in the industry is very, very, very dirty." |
他泪流满面地说, “这个产业里发生的一切 非常、非常、非常肮脏。” |
| In the US, a confidential source who worked in the government handed me a thumb drive containing over 20,000 internal FDA documents. |
在美国,一位在政府工作的线人 给了我一个 USB 闪存盘, 其中含有超过两万份 美国药监局的内部文件。 |
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described:v.描述;形容;把…称为;做…运动;(describe的过去分词和过去式) well-oiled:adj.谄媚的;平滑的;烂醉的; machinery:n.机械;机器;机构;机械装置; manipulation:n.操作;管理措施;处理;操纵证券市场;变换; compromised:v.妥协,折中,让步; (compromise的过去分词和过去式) source:n.来源;水源;原始资料; thumb:v.翻阅;以拇指拨弄;作搭车手势;笨拙地摆弄;n.拇指;
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| The emails and memos revealed how the agency's public health mission -- protecting consumers -- often clashed with its political mission -- showing Congress a steady stream of low-cost drug approvals . |
这些电子邮件和记事揭露了 该机构的公共卫生使命—— 保护消费者—— 常常和它的政治使命冲突—— 给国会呈现持续稳定的廉价药物许可。 |
| I also learned about the FDA's compromised inspection system for overseas drug plants. |
我还得知,美国药监局 针对海外药厂的巡查系统 漏洞百出。 |
| In the US, FDA investigators arrive unannounced to do surprise inspections . |
在美国,药监局调查员 会未经事前通知地 进行突击检查。 |
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memos:n.备忘录,备注留言板(memo复数); revealed:v.揭示;显示;露出;(reveal的过去分词和过去式) mission:n.使命,任务;代表团;布道;v.派遣;向…传教; consumers:n.消费者;顾客;用户;(consumer的复数) clashed:v.打斗;冲突;比赛;争论;(clash的过去分词和过去式) Congress:n.国会;代表大会;会议;社交; steady:adj.稳定的; v.使稳定; v.稳定地; n.关系固定的情侣; approvals:n.批准;认可;赞成;(approvals是approval的复数) inspection:n.视察,检查; investigators:n.研究者,调查者(investigator的复数形式); unannounced:adj.突然的;未经宣布的;未通知的; inspections:n.检查;视察;安全检测(inspection的复数);
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| But overseas, the FDA gives manufacturing plants months of advance notice. |
但在海外,药监局给生产厂商 长达数月的提前通知。 |
| It asks for the company's help arranging ground transportation and hotels. |
它要寻求海外公司的帮助 安排交通和住宿。 |
| My sources also talked about staged inspections, where teams of data fabricators invent or alter needed documents to create a facade of compliance long before the FDA arrives. |
我的消息来源 还提到了预演好的检查, 几支篡改数据的队伍 对文件进行捏造或改动, 早在药监局到来之前 就制造好遵守规章的假象。 |
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arranging:v.安排;筹备;整理;排列;(arrange的现在分词) transportation:n.运输;运输系统;运输工具;流放; sources:n.来源;出处;起源;根源;原因;v.(从…)获得(source的第三人称单数和复数) facade:n.正面;表面;外观; compliance:n.顺从,服从;承诺;
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| One intrepid FDA investigator named Peter Baker figured out how to find the truth. |
一位彪悍的美国药监局调查员, 彼得 · 贝克（Peter Baker）, 发现了该如何找到真相。 |
| He ignored the data printouts , and he looked inside company computers. |
他无视了打印出的数据, 直接查看公司电脑。 |
| When files were deleted, he found metadata revealing hidden tests. |
当有文件被删除时, 他找到了元数据, 发现了隐藏起来的测试数据。 |
| The companies were prescreening their drugs, figuring how to alter the official tests so they would meet FDA specifications . |
这些公司在预先审查它们的药物, 研究该怎样修改正式测试结果, |
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intrepid:adj.无畏的;勇敢的;勇猛的; Baker:n.面包(糕饼)师傅;面包店老板; ignored:v.忽视;对…不予理会;佯装未见;不予理睬;(ignore的过去分词和过去式) printouts:[计]打印输出; metadata:n.[计]元数据; prescreening:v.预先筛分;试销(prescreen的ing形式); official:adj.官方的;正式的;公务的;n.官员;公务员;高级职员; specifications:n.规格;规范;明细单;说明书;(specification的复数)
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| As I said , this problem is more than a handful of bad actors. |
如我所说,这个问题 远比一群蹩脚演员要严重。 |
| Over four years, Peter Baker inspected 86 plants in India and China. |
在四年时间里,彼得 · 贝克巡视了 位于印度和中国的 86 间工厂。 |
| He found evidence of fraud in 67 of them. |
在其中 67 间工厂里, 他都发现了造假的证据。 |
| Wonder what happens to a batch of drugs that fails testing? |
你是否想过未能通过 测试的药物批次去了哪里？ |
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As I said:正如我所说的 inspected:v.检查;查看;审视;视察;(inspect的过去式和过去分词) evidence:n.证据,证明;迹象;明显;v.证明;
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| It should get thrown out. |
它们本应被销毁。 |
| Instead, low-cost plants usually sell them into poorly regulated markets that don't realize what they're getting, places like Africa, |
然而,低成本工厂常常 把这些药物卖给监管不力、 并不知道入手了什么东西的市场, 比如非洲、 |
| Southeast Asia and India itself. |
东南亚 和印度自己。 |
| The overseas generics industry calls this " dual-track production" -- better drugs for some, failed drugs for others. |
海外仿制药产业把这个 称为 “双轨生产”—— 给某些地方提供优质药物, 给其它地方提供劣质药物。 |
| In the developing world, this corrupt system has flooded the market with so many bad drugs that public health researchers link them to the rise of drug-resistant infections . |
在发展中世界里, 这个腐败的系统导致市场上 充斥了如此繁多的劣质药物, 以至于公共卫生研究员认为 这些劣质药和耐药性 感染的增长有所关联。 |
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Southeast:adj.东南的;来自东南的;n.东南;东南地区;adv.来自东南; dual-track:双轨的; corrupt:v.损坏;破坏;使腐化;使堕落;adj.贪污的;受贿的;腐败的;营私舞弊的; drug-resistant:adj.耐药的;抗药性的; infections:n.传染病;口腔病害(infection复数形式);
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| But criminal behavior by overseas companies is only half the problem. |
但海外公司的犯罪行为 仅仅是问题的一半。 |
| Though some regulators apparently don't realize they're being conned , in the US, our regulators appear willing to overlook transgressions in order to continue green-lighting low-cost medicine. |
虽然有些监管者明显 没有意识到自己受到了欺诈, 在美国,我们的监管者看上去 甘愿对违规行为视而不见, 以便继续放行廉价的药物。 |
| As a result , some American patients have gotten generic drugs with toxic impurities , unapproved ingredients, dangerous particulates or that are not bioequivalent. |
结果,某些美国患者 拿到的仿制药中含有有毒杂质、 未经许可的成分、 危险的颗粒物, 或是不具有生物等效性的成分。 |
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apparently:adv.显然地;似乎,表面上; conned:v.欺骗,哄骗,诈骗(con的过去分词和过去式) overlook:v.忽略;俯视;视而不见;眺望; transgressions:n.罪过;海侵;违反;超越;(transgression的复数) As a result:结果; toxic:adj.有毒的;中毒的; impurities:n.杂质(impurity的复数); particulates:n.微粒;大气尘;微粒物质;空气中微小颗粒(particulate的复数形式);
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| As the FDA investigator Peter Baker put it, if people actually understood, then nobody would take these drugs. |
正如美国药监局的 调查员彼得 · 贝克所说, 如果人们真的理解其中利害, 那么没人会服用这些药物。 |
| Are there ways to solve this global problem? |
有办法解决这个全球性的问题吗？ |
| Yes, there are. |
答案是肯定的。 |
| Solutions begin with recognizing that our current honor system for drug regulation is a relic of a bygone age. |
想要开始解决问题,我们就要承认 目前药厂的自主药物监管系统 已不再属于这个时代了。 |
| Science evolves . Medicine evolves . |
科学在进步,医药在进步。 |
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global:adj.全球的;总体的;球形的; recognizing:v.认识;认出;承认;接受,赞成(recognize的现在分词) relic:n.遗迹,遗物;废墟;纪念物; bygone:adj.过去的;n.过去的事; evolves:v.进化,进展(evolve的第三人称单数形式);
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| The global economy evolves. |
全球经济在进步。 |
| Shouldn't regulation evolve with them? |
监管制度难道不应该也一起进步吗？ |
| Only one approach can guarantee quality generics: rigorous oversight , including unannounced inspections and systematic testing of drugs. |
只有一种方法能保证仿制药的质量: 严格的监督, 包括突击检查, 以及对药物进行系统性测试。 |
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economy:n.经济;节约;理财; approach:n.方法;路径;v.接近;建议;着手处理; guarantee:n.保证;担保;保证人;保证书;抵押品;v.保证;担保; rigorous:adj.严格的,严厉的;严密的;严酷的; oversight:n.疏忽;忽略;失察;负责;照管; systematic:adj.系统的;体系的;有系统的;[图情]分类的;一贯的,惯常的;
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| Rigorous oversight means that regulators don't just look at printouts of data that may or may not be genuine . |
严格的监督意味着 监管者不应只看打印出的、 可能真实也可能虚假的数据。 |
| Effective solutions also depend on giving the average patient more information. |
有效的解决方案也需要 给一般患者提供更多信息。 |
| We know where our breakfast cereal and our running shoes are manufactured . |
我们知道我们的早餐麦片和跑鞋 是在哪里生产的。 |
| Why is it different for generic drugs? |
为什么仿制药要区别对待？ |
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genuine:adj.真实的,真正的;诚恳的; cereal:n.谷物;谷类植物;adj.谷类制成的; manufactured:adj.制造的,已制成的;v.制造,加工(manufacture的过去式);
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| Patients can do something else. |
患者还能做些别的事。 |
| They can tell their elected officials and consumer organizations to speak up just as loudly to demand quality as they do to demand access. |
他们可以告诉选举出的 官员和消费者组织, 应像要求获取药物时一样 大声地呼吁要求质量。 |
| Consumer organizations can do their members a great service by testing and ranking generics, just like cars and washing machines. |
消费者组织若是能 像汽车和洗衣机行业一样 对仿制药进行检测和分级排名, 会对其消费者大有裨益。 |
| The big pharmacy chains owe it to the public to test the drugs they dispense . |
大型连锁药房应肩负对大众的责任, 检测它们出售的药品。 |
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organizations:n.组织,构造,有机体(organization的复数);组织机构; pharmacy:n.药房;配药学,药剂学;制药业;一批备用药品; dispense:v.分配;分发;提供;配药;
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| A trip to the pharmacy for affordable medicine shouldn't come with a hidden cost. |
去药房购买负担得起的药品 不应有任何隐藏消费。 |
| Now is the time for all of us who care about patient safety to act on what we know. |
对于所有关心病人 安全的人而言,现在正是 根据我们了解的情况 采取行动的时刻。 |
| Thank you. |
谢谢。 |
| (Applause) |
（掌声） |