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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。
Joe believed the patients' claims. But when he reported these complaints to the FDA, officials there argued,
乔相信了病人的说法。但当他把这些投诉上报给美国食物及药品管理局时，那里的官员辩解说，
"It was probably psychosomatic. Patients are upset by pills that look different from their old ones."
“可能只是心理作用。药片的样子和以前的不同，病人因此觉得不满。”
Joe didn't buy it. He wanted someone with investigative firepower to dig into this, and since I was an investigative journalist, he called me.
乔没有买账。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。
Our health care system relies on generics. My family does, too.
我们的医疗系统依赖仿制药。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
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，以及数千份机密文件，
from the FDA, from generic drug companies and from the courts -- all pointed me in the same direction:
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，都将我指向了同一个方向：
a large number of generic drug manufacturers in certain overseas countries are passing off substandard drugs as legitimate generics for profit.
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。
They are deliberately flouting FDA regulations and standards. Basically, they are committing fraud.
他们公然无视了药监局的规章和标准。本质上说，他们犯了欺诈罪。
In the process, they are risking the health of patients around the world. They may even be costing patient lives.
在这个过程中，他们让世界各地患者的健康遭受威胁，甚至有可能危及患者的生命。
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。
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. I knew generic HIV/AIDS medicine had saved many lives in Africa.
今天，我们90%的药物是仿制药。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、医疗补助和平价医疗法案都要依靠仿制药。
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,
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，
but bioequivalent, interchangeable with the brand and with one another.
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。
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, I uncovered a different, unwritten set of rules.
但在遥远的药厂里，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. Instead, it reviews company data.
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依据的不是对药物的测试，而是对公司数据的审核。
As the FDA's generic drugs director actually told me,
正如美国药监局仿制药的主任告诉我的，
"The approval system requires the ethical behavior of the applicant. Otherwise, the whole house of cards will fall down."
“许可系统需要申请者的行为合乎伦理道德规范。否则，整个系统都会崩塌。”
Really? It's the honor system?
真的？仅仅依靠自觉吗？
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。
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”。
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。
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, I'd better go look where the majority of our generic drugs are made: in India and China.
他说，如果我真的想调查这个问题的真相，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。
Any generic drug company anywhere in the world wanting approval to sell its drugs into our market
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，
has to follow elaborate rules known as "Good Manufacturing Practices."
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, I watched as technicians ran tests on specialized machines
在新泽西一间顶尖实验室，我看着技术员在专业机器上进行测试，
and used flasks that mimic stomach conditions to measure drug dissolution.
用模仿胃部条件的烧瓶测量药物的溶解过程。
But one remarkable fact jumped out. The lab banned Wite-Out -- correction fluid -- across its facility.
但有一个细节引起了我的注意。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. Wite-Out was high-risk. It invited tampering.
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。涂改液会带来很大风险。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。
But what if neither was true? What if the applicant was not ethical? What if the data was not pristine?
但要是两者都被违反了呢？要是申请者并不道德？要是数据并非原始版本？
I started to hear about a company in India called Ranbaxy, India's largest drug company,
我开始听说一家位于印度叫兰伯西的公司，它是印度最大的制药公司，
one of its first successful multinationals and one of the fastest-growing generic suppliers to the US market.
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。
A whistleblower was supplying internal Ranbaxy documents to the FDA. I got copies.
一位知情者把兰伯西的内部文件提供给了美国药监局，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。
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。
In 2004, Ranbaxy hired a new research and development director. He suspected something was amiss.
2004年，兰伯西雇佣了一位新的研发部主任。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.
于是他便委任一位名叫迪内西·塔库尔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。
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。
Then they forced Thakur out of the company. Thakur couldn't sleep, thinking about Ranbaxy's perilously bad drugs.
然后他们强行把塔库尔开除了。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. After an eight-year investigation, Ranbaxy pled guilty to seven felonies for faking data.
于是他冒着生命危险，向美国药监局发出了警报。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,
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”，
there were fast drugs, too, made in pharmaceutical sweatshops overseas with low-quality ingredients and manufacturing shortcuts.
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。
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
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，
had knowingly released drug batches that contained glass particles.
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,
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，
even when they doubled and tripled the doses.
即使剂量已经翻了两倍或三倍。
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。
The emails and memos revealed how the agency's public health mission -- protecting consumers
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，
often clashed with its political mission -- showing Congress a steady stream of low-cost drug approvals.
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。
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,
我的消息来源还提到了预演好的检查，
where teams of data fabricators invent or alter needed documents to create a facade of compliance long before the FDA arrives.
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。
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，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，使其符合美国药监局的规章细则。
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. He found evidence of fraud in 67 of them.
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。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? It should get thrown out.
你是否想过未能通过测试的药物批次去了哪里？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,
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，
places like Africa, Southeast Asia and India itself.
比如非洲、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
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，
that public health researchers link them to the rise of drug-resistant infections.
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。
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,
虽然有些监管者明显没有意识到自己受到了欺诈，
in the US, our regulators appear willing to overlook transgressions in order to continue green-lighting low-cost medicine.
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,
结果，某些美国患者拿到的仿制药中含有有毒杂质、
unapproved ingredients, dangerous particulates or that are not bioequivalent.
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。
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? Yes, there are.
有办法解决这个全球性的问题吗？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. The global economy evolves. Shouldn't regulation evolve with them?
科学在进步，医药在进步。全球经济在进步。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。
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. Why is it different for generic drugs?
我们知道我们的早餐麦片和跑鞋是在哪里生产的。为什么仿制药要区别对待？
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。
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. Thank you.
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。谢谢。
