关于仿制药的一剂现实真相 Katherine Eban: A dose of reality about generic drugs

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演员: Katherine Eban


台词
In 2008, I got an unusual phone call
2008 年,我接到了 一通不同寻常的电话
from a guy named Joe Graedon.
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
乔说,最近他收到了大量的投诉
who had recently been switched to generic drugs.
来自近期改服仿制药的患者们。
Joe was a trained pharmacologist
乔是一位训练有素的药剂师,
and cohost of a radio show on NPR.
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
一位又一位病人抱怨说, 仿制药带来了许多不良副作用,
or even relapses.
甚至导致病情复发。
Joe believed the patients' claims.
乔相信了病人的说法。
But when he reported these complaints to the FDA,
但当他把这些投诉上报给 美国食物及药品管理局(FDA)时,
officials there argued, "It was probably psychosomatic.
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。”
Joe didn't buy it.
乔没有买账。
He wanted someone with investigative firepower
他想请有调查火力的人
to dig into this,
深挖这个情况,
and since I was an investigative journalist,
因为我是一名调查记者,
he called me.
他便联系了我。
And then he posed a question
然后他提出了一个问题,
that I couldn't get out of my head:
一个在我脑海里挥之不去的问题:
"Katherine, what is wrong with the drugs?"
“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.
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,
但经过十年的采访,
meetings with whistleblowers,
与知情者的会面,
on-the-ground reporting across four continents
跨越四大洲的实地探访,
and thousands of confidential files --
以及数千份来自——
from the FDA,
美国食物及药品管理局,
from generic drug companies
来自仿制药公司,
and from the courts --
以及来自法庭的机密文件——
all pointed me in the same direction:
都将我指向了同一个方向:
a large number of generic drug manufacturers
在某些海外国家的
in certain overseas countries
许多仿制药生产商
are passing off substandard drugs
在把假冒伪劣的药品
as legitimate generics
伪装成合法仿制药出售
for profit.
以攫取利润。
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。
One leading company in India has already shut down
印度有一家大型制药厂就
because of this activity.
已经因为这些行为关闭。
I wanted to know,
我想知道,
was that company an outlier
那家公司是个例,
or the tip of the iceberg?
还是冰山一角?
What I uncovered is disquieting,
我的发现令人不安。
and anyone who takes generic drugs has the right to be deeply concerned.
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,
如果你对我说的任何事表示怀疑,
that's fair.
那都是情有可原的。
I saw generics as one of the world's great public health innovations,
我认为仿制药是世界上 非常伟大的公共医疗创举,
a giant win for patients worldwide.
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,
在美国,
programs from Medicare to Medicaid and the Affordable Care Act
联邦医疗保险(Medicare)、 医疗补助(Medicaid)
depended on them.
和平价医疗法案 (Affordable Care Act)
In an overpriced drug market,
都要依靠仿制药。
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
但我最大的假设是 基于美国药监局的保证,
that properly regulated generic drugs
即正确监管的仿制药
are not only safe and effective,
不仅安全有效,
but bioequivalent,
还具有生物等效性,
interchangeable with the brand and with one another.
和品牌药以及其他 仿制药能够互换使用。
Well, that's true --
好,这点确实没错——
if companies follow the rules on paper.
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:
很快,有了一个另外吃惊的事实:
the FDA does not vet manufacturer applications by testing the drugs.
美国食物及药品管理局 筛查药物制造商的申请
Instead, it reviews company data.
依据的不是对药物的测试,
As the FDA's generic drugs director actually told me,
而是对公司数据的审核。
"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,
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。
Really?
否则,整个系统都会崩塌。”
It's the honor system?
真的?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
我讲述了改服仿制药的患者
and suffered medical setbacks.
如何遭受了病情恶化。
I quoted doctors
我引述了医生们的话,
who questioned whether generics really were bioequivalent to the brand.
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
一个月之后, 我收到了一封匿名邮件
from someone calling himself "Four Dollar Refill."
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。
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:
我最好应该去看看 大部分仿制药被生产的地方:
in India and China.
印度和中国。
Four Dollar Refill was right;
“四美元续药” 是对的;
80 percent of the plants making the active ingredient
制造我们所有的药物, 包括品牌药和仿制药的
for all our drugs, brand or generic,
活性成分的工厂
are overseas,
有 80% 都位于海外,
mostly in China and India.
主要在中国和印度。
Any generic drug company anywhere in the world
在世界任何地方的任何仿制药公司
wanting approval to sell its drugs into our market
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
我决定去学习
of how to manufacture a legitimate generic drug.
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
我看着技术员在专业机器上进行测试,
and used flasks that mimic stomach conditions
用模仿胃部条件的烧瓶
to measure drug dissolution.
测量药物的溶解过程。
But one remarkable fact jumped out.
但有一个细节引起了我的注意。
The lab banned Wite-Out --
这间实验室——
correction fluid --
在所有设施中
across its facility.
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,
在生产的每一步骤都必须收集、
preserved
保管数据,
and shared with regulators.
并将其与监管者分享。
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,
很明确的是, 药监局的监管制度想要成功实施,
any company applying for approval had to be ethical,
任何申请许可的公司 都必须遵守伦理道德规范,
and its data had to be unaltered.
且其数据必须是未经改动的。
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,
它是印度最大的制药公司,
one of its first successful multinationals
是印度首批成功的跨国公司,
and one of the fastest-growing generic suppliers to the US market.
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.
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
解读了这家公司的图表和数据后,
unveiled a shocking swindle.
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,
他们编造出类似 标准操作流程的文件,
steaming them overnight in a sauna-like room
在桑拿房一样的房间中 连夜干蒸这些文件,
to make them look old.
让它们看上去像用旧了一样。
They conjured up three-, six-, nine- and 18-month stability studies,
他们捏造出 3 个月、6 个月、 9 个月和 18 个月的稳定性研究,
all generated on the same day.
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.
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
于是便委任一位名叫迪内西·塔库尔 (Dinesh Thakur)的年轻工程师
to study the data in every drug application
研究每一份药物申请中的数据,
to find out if it was real or fake.
辨别数据的真伪。
Thakur eventually put together a devastating PowerPoint
塔库尔最后整理出 一份骇人听闻的 PPT 演示,
showing Ranbaxy had falsified data for over 200 products
表明兰伯西在 200 多件 产品中伪造了数据,
in more than 40 countries.
波及 40 多个国家。
The new R and D director showed this PowerPoint
新任研发部主任把这份演示
to a subcommittee of the board of directors.
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
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
destroyed.
进行销毁。
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,
塔库尔夜不能寐,
thinking about Ranbaxy's perilously bad drugs.
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
经过一场为期八年的调查, 兰伯西承认了七项
for faking data.
伪造数据的重罪。
An FDA consultant taught me
一位药监局的顾问告诉我,
that just like cheap clothing made in distant factories,
就像在遥远工厂中 生产的廉价服装一样,
or "fast fashion," as she called it,
她将其称之为 “快餐时装” ,
there were fast drugs, too,
也有 “快餐药物” ,
made in pharmaceutical sweatshops overseas
是在海外制药业的血汗工厂里,
with low-quality ingredients and manufacturing shortcuts.
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
他递给我的文件中揭露了他所工作的
where he worked
削减成本的仿制药工厂
had knowingly released drug batches
是如何在知情的情况下释出了
that contained glass particles.
含有玻璃颗粒的药物批次。
In Accra, capital of Ghana,
在加纳的首都阿克拉,
doctors explained how low-cost Indian and Chinese medicine of all kinds
医生们解释说, 各种廉价的印度和中国药物
barely seemed to work,
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
在孟买,我见了另一位知情者,
from a company that I had believed was ethical.
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
他坐在那里描述了 自己的公司如何熟练地运作
of data manipulation
数据操纵的机制,
his company used to get compromised drugs approved fast.
以便让有问题的药物能快速过审。
With tears running down his cheeks, he said,
他泪流满面地说,
"What's going on in the industry
“这个产业里发生的一切
is very, very, very dirty."
非常、非常、非常肮脏。”
In the US, a confidential source who worked in the government
在美国,一位在政府工作的线人
handed me a thumb drive
给了我一个 USB 闪存盘,
containing over 20,000 internal FDA documents.
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 --
这些电子邮件和记事揭露了 该机构的公共卫生使命——
protecting consumers --
保护消费者——
often clashed with its political mission --
常常和它的政治使命冲突——
showing Congress a steady stream of low-cost drug approvals.
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
我还得知,美国药监局 针对海外药厂的巡查系统
for overseas drug plants.
漏洞百出。
In the US, FDA investigators arrive unannounced
在美国,药监局调查员 会未经事前通知地
to do surprise inspections.
进行突击检查。
But overseas, the FDA gives manufacturing plants
但在海外,药监局给生产厂商
months of advance notice.
长达数月的提前通知。
It asks for the company's help arranging ground transportation
它要寻求海外公司的帮助 安排交通和住宿。
and hotels.
我的消息来源 还提到了预演好的检查,
My sources also talked about staged inspections,
几支篡改数据的队伍 对文件进行捏造或改动,
where teams of data fabricators invent or alter needed documents
早在药监局到来之前 就制造好遵守规章的假象。
to create a facade of compliance long before the FDA arrives.
一位彪悍的美国药监局调查员, 彼得 · 贝克(Peter Baker),
One intrepid FDA investigator named Peter Baker
发现了该如何找到真相。
figured out how to find the truth.
他无视了打印出的数据,
He ignored the data printouts,
直接查看公司电脑。
and he looked inside company computers.
当有文件被删除时,
When files were deleted,
他找到了元数据, 发现了隐藏起来的测试数据。
he found metadata revealing hidden tests.
这些公司在预先审查它们的药物,
The companies were prescreening their drugs,
研究该怎样修改正式测试结果,
figuring how to alter the official tests so they would meet FDA specifications.
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
在四年时间里,彼得 · 贝克巡视了
in India and China.
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?
It should get thrown out.
它们本应被销毁。
Instead, low-cost plants usually sell them into poorly regulated markets
然而,低成本工厂常常 把这些药物卖给监管不力、
that don't realize what they're getting,
并不知道入手了什么东西的市场,
places like Africa,
比如非洲、
Southeast Asia
东南亚
and India itself.
和印度自己。
The overseas generics industry calls this "dual-track production" --
海外仿制药产业把这个 称为 “双轨生产”——
better drugs for some,
给某些地方提供优质药物,
failed drugs for others.
给其它地方提供劣质药物。
In the developing world,
在发展中世界里,
this corrupt system has flooded the market
这个腐败的系统导致市场上
with so many bad drugs
充斥了如此繁多的劣质药物,
that public health researchers link them
以至于公共卫生研究员认为
to the rise of drug-resistant infections.
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
在美国,我们的监管者看上去 甘愿对违规行为视而不见,
in order to continue green-lighting low-cost medicine.
以便继续放行廉价的药物。
As a result, some American patients
结果,某些美国患者
have gotten generic drugs with toxic impurities,
拿到的仿制药中含有有毒杂质、
unapproved ingredients,
未经许可的成分、
dangerous particulates
危险的颗粒物,
or that are not bioequivalent.
或是不具有生物等效性的成分。
As the FDA investigator Peter Baker put it,
正如美国药监局的 调查员彼得 · 贝克所说,
if people actually understood,
如果人们真的理解其中利害,
then nobody would take these drugs.
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
想要开始解决问题,我们就要承认
that our current honor system for drug regulation
目前药厂的自主药物监管系统
is a relic of a bygone age.
已不再属于这个时代了。
Science evolves. Medicine evolves.
科学在进步,医药在进步。
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:
只有一种方法能保证仿制药的质量:
rigorous oversight,
严格的监督,
including unannounced inspections and systematic testing of drugs.
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
严格的监督意味着 监管者不应只看打印出的、
that may or may not be genuine.
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?
Patients can do something else.
患者还能做些别的事。
They can tell their elected officials and consumer organizations
他们可以告诉选举出的 官员和消费者组织,
to speak up just as loudly to demand quality
应像要求获取药物时一样
as they do to demand access.
大声地呼吁要求质量。
Consumer organizations can do their members a great service
消费者组织若是能 像汽车和洗衣机行业一样
by testing and ranking generics,
对仿制药进行检测和分级排名,
just like cars and washing machines.
会对其消费者大有裨益。
The big pharmacy chains owe it to the public
大型连锁药房应肩负对大众的责任,
to test the drugs they dispense.
检测它们出售的药品。
A trip to the pharmacy for affordable medicine
去药房购买负担得起的药品
shouldn't come with a hidden cost.
不应有任何隐藏消费。
Now is the time for all of us who care about patient safety
对于所有关心病人 安全的人而言,现在正是
to act on what we know.
根据我们了解的情况 采取行动的时刻。
Thank you.
谢谢。
(Applause)
(掌声)