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I wanted to know, was that company an outlier or the tip of the iceberg?
خواستم بدانم، آیا این شرکت یک استثنا است یا اینکه تنها قطره ای است از دریا؟
en-fa
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。
en-zh-cn
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。
en-zh-cn
I saw generics as one of the world's great public health innovations, a giant win for patients worldwide.
من داروهای ژنریک را یکی از بزرگترین نوآوری‌های حوزه سلامت عمومی تصور می‌کردم، برگ برنده‌ای عظیم برای بیماران در سرتاسر دنیا.
en-fa
Ninety percent of our drugs today are generic.
今天,我们 90% 的药物是仿制药。
en-zh-cn
I knew generic HIV/AIDS medicine had saved many lives in Africa.
من می‌دانستم داروی ژنریک اچ‌آی‌وی/ایدز جان افراد زیادی درآفریقا را نجات داده است.
en-fa
Here at home, programs from Medicare to Medicaid and the Affordable Care Act depended on them.
Ici, dans notre pays, les programmes comme Medicare, Medicaid et l'Obamacare en dépendent.
en-fr
In an overpriced drug market, generics were the heroic underdog.
Sur un marché pharmaceutique surévalué, les génériques sont le héros méconnus.
en-fr
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.
Mas minha maior suposição era baseada na garantia da FDA de que medicamentos genéricos adequadamente regulamentados não são apenas seguros e eficazes, mas bioequivalentes, intercambiáveis com a marca e entre si.
en-pt-br
Well, that's true -- if companies follow the rules on paper.
C'est vrai – si les entreprises suivent les règles.
en-fr
But inside far-flung drug plants, I uncovered a different, unwritten set of rules.
Mas dentro de fábricas remotas, descobri um conjunto diferente de regras não escritas.
en-pt-br
I started my investigation by focusing on the regulatory framework.
Comecei minha investigação focando a estrutura regulatória.
en-pt-br
Right away, one fact surprised me: the FDA does not vet manufacturer applications by testing the drugs.
Et immédiatement, une chose m'a surprise : La FDA ne valide pas la demande avec un test des médicaments concernés.
en-fr
Instead, it reviews company data.
Em vez disso, analisa os dados da empresa.
en-pt-br
As the FDA's generic drugs director actually told me, "The approval system requires the ethical behavior of the applicant.
Et le directeur du département des génériques de la FDA me l'a affirmé : « Le système d'approbation exige une exemplarité éthique du demandeur.
en-fr
Otherwise, the whole house of cards will fall down."
Sans quoi toute la structure s'effondre comme un château de cartes.
en-fr
It's the honor system?
É o sistema de honra?
en-pt-br
(Laughter) After nine months of digging, I published my first article on generics.
(笑声) 经过九个月的调查, 我发表了第一篇关于仿制药的文章。
en-zh-cn
I wrote about patients who'd been switched to generic drugs and suffered medical setbacks.
J'ai relaté le récit de patients qui sont passés aux génériques et qui ont subi des revers médicaux.
en-fr
I quoted doctors who questioned whether generics really were bioequivalent to the brand.
Citei médicos que questionaram se os genéricos realmente eram bioequivalentes à marca.
en-pt-br
A month later, I got an anonymous email from someone calling himself "Four Dollar Refill."
Um mês depois, recebi um e-mail anônimo de alguém que se denominava "Refil de US$ 4".
en-pt-br
(Laughter) Four dollars is what you'd pay to fill a generic prescription at Walmart.
(Risos) É o que se pagaria para preencher uma receita genérica no Walmart.
en-pt-br
Four Dollar Refill worked inside the generic drug industry.
O meu denunciante trabalhava na indústria de medicamentos genéricos.
en-pt-br
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.
او می‌گفت اگر من واقعاً می‌خواهم مشکل را کشف کنم بهتر است بروم و نگاهی به اکثریت شرکت‌های تولیدکننده داروهای ژنریک بیندازم در هند و چین.
en-fa
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.
جبران چهار دلاری راست می‌گفت. هشتاد درصد از کارخانه‌های تولیدکننده مواد اولیه فعال برای همه داروها چه برند و چه ژنریک، خارجی هستند، و اغلب در چین و هند.
en-fa
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."
Toute entreprise pharmaceutique de génériques dans le monde qui souhaite vendre ses médicaments sur nos marchés doit suivre des règles élaborées, les « bonnes pratiques de fabrication ».
en-fr
I decided to learn every detail of how to manufacture a legitimate generic drug.
J'ai donc décidé d'apprendre dans le moindre détail comment on fabrique un médicament générique valable.
en-fr
At a top New Jersey lab, I watched as technicians ran tests on specialized machines and used flasks that mimic stomach conditions to measure drug dissolution.
Num laboratório de Nova Jersey, observei enquanto os técnicos faziam testes em máquinas especializadas e frascos usados que imitam as condições do estômago para medir a dissolução de drogas.
en-pt-br
But one remarkable fact jumped out.
但有一个细节引起了我的注意。
en-zh-cn
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。
en-zh-cn
Under FDA rules, data serves as the cornerstone of quality.
Sob as regras da FDA, os dados servem como o pilar da qualidade.
en-pt-br
It has to be gathered at each manufacturing step, preserved and shared with regulators.
این داده‌ها باید در هر مرحله تولید جمع‌آوری شود، حفظ شود و با بازرسان در میان گذاشته شود.
en-fa
Wite-Out was high-risk.
Le tipp-ex représente un risque élevé.
en-fr
It invited tampering.
انگیزه‌ایست برای دستکاری.
en-fa
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.
Manifestement, pour que le système réglementaire de la FDA fonctionne bien. toutes les entreprises qui envoient une demande doivent être éthiques et leurs données doivent être intactes.
en-fr
But what if neither was true?
Et si aucune des conditions n'est remplie ?
en-fr
What if the applicant was not ethical?
E se o requerente não fosse ético?
en-pt-br
What if the data was not pristine?
E se os dados não estivessem intactos?
en-pt-br
I started to hear about a company in India called Ranbaxy, India's largest drug company, one of its first successful multinationals and one of the fastest-growing generic suppliers to the US market.
Comecei a escutar sobre uma empresa na Índia chamada Ranbaxy, a maior empresa farmacêutica do país, uma de suas primeiras multinacionais de sucesso e um dos fornecedores de genéricos que mais cresce no mercado dos EUA.
en-pt-br
A whistleblower was supplying internal Ranbaxy documents to the FDA.
Um denunciante estava fornecendo documentos internos da Ranbaxy à FDA.
en-pt-br
I got copies.
Eu consegui cópias.
en-pt-br
Deciphering the company's charts, graphs and numbers unveiled a shocking swindle.
با رمزگشایی جداول، نمودارها و اعداد یک کلاه‌برداری خیره‌کننده کشف شد.
en-fa
They substituted unapproved, lower-purity ingredients.
他们替换了未经批准的、 低纯度的原料。
en-zh-cn
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。
en-zh-cn
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。
en-zh-cn
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。
en-zh-cn
In 2004, Ranbaxy hired a new research and development director.
در سال ۲۰۰۴ رانباکسی مدیر تحقیق و توسعه جدیدی استخدام کرده بود.
en-fa
He suspected something was amiss.
او شک کرده بود که برخی چیزها نادرست است.
en-fa
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。
en-zh-cn
Thakur eventually put together a devastating PowerPoint showing Ranbaxy had falsified data for over 200 products in more than 40 countries.
Thakur acabou preparando um PowerPoint inacreditável mostrando que a Ranbaxy havia falsificado dados de mais de 200 produtos em mais de 40 países.
en-pt-br
The new R and D director showed this PowerPoint to a subcommittee of the board of directors.
Le nouveau directeur de la R&D a montré ces chiffres à un sous-comité du conseil d'administration.
en-fr
The subcommittee ordered the report and the laptop on which it was created destroyed.
کمیته فرعی دستور می‌دهد تا این گزارش و لپ‌تابی که این گزارش در آن تولید شده نابود شود.
en-fa
Then they forced Thakur out of the company.
然后他们强行把塔库尔开除了。
en-zh-cn
Thakur couldn't sleep, thinking about Ranbaxy's perilously bad drugs.
تاکور نمی‌توانست بخوابد، و در مورد داروهای خطرناک رانباکسی فکر می‌کرد.
en-fa
So he risked his life to alert the FDA.
Alors, il a risqué sa vie pour alerter la FDA.
en-fr
After an eight-year investigation, Ranbaxy pled guilty to seven felonies for faking data.
پس از ۸ سال بررسی، رانباکسی به هفت نوع خیانت برای تولید داده‌های جعلی محکوم شد.
en-fa
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.
Un consultant de la FDA m'a appris que c'est comme la mode bon marché, produite dans des usines éloignées, la « fast-fashion », comme on dit. Il y a aussi des « médicaments rapides » fabriqués dans des ateliers pharmaceutiques de misère avec des ingrédients de piètre qualité et des raccourcis de production.
en-fr
In Mexico City, I sat in a bar with a whistleblower.
J'ai pris un verre avec un lanceur d'alerte à Mexico.
en-fr
He handed me documents revealing how the cost-cutting generic drug plant where he worked had knowingly released drug batches that contained glass particles.
Ele me deu documentos revelando como a fábrica de genéricos que reduz custos, onde ele trabalhava, conscientemente liberou lotes de remédios que continham partículas de vidro.
en-pt-br
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.
در آکرا پایتخت غنا، پزشکان توضیح می‌دادند که همه انواع داروهای هندی و چینی به ندرت درست عمل می‌کنند، حتی هنگامی که دوز دارو را دو یا سه برابر می‌کنند.
en-fa
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。
en-zh-cn
He sat there and described the well-oiled machinery of data manipulation his company used to get compromised drugs approved fast.
Ele descreveu o eficaz sistema de manipulação de dados que a empresa usava para aprovar rapidamente medicamentos comprometidos.
en-pt-br
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。”
en-zh-cn
In the US, a confidential source who worked in the government handed me a thumb drive containing over 20,000 internal FDA documents.
Aux États-Unis, une source confidentielle qui travaille pour le gouvernement m'a remis une clé USB avec plus de 20 000 documents internes de la FDA.
en-fr
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.
ایمیل‌ها و یادداشت‌ها نحوه حفاظت از اسرار مشتری توسط مأموریت بهداشت عمومی را نشان می‌داد-- که غالباً با مأموریت‌های سیاسی تداخل می‌کرد-- به کنگره تعداد یکنواختی از صدور مجوزهای داروی ارزان را نشان می‌داد
en-fa
I also learned about the FDA's compromised inspection system for overseas drug plants.
Eu também descobri o sistema de inspeção comprometido da FDA das instalações farmacêuticas no exterior.
en-pt-br
In the US, FDA investigators arrive unannounced to do surprise inspections.
Nos EUA, pesquisadores da FDA chegam sem aviso prévio para fazer auditorias surpresa.
en-pt-br
But overseas, the FDA gives manufacturing plants months of advance notice.
Mais à l'étranger, la FDA envoie aux centres de production une annonce un mois avant la visite.
en-fr
It asks for the company's help arranging ground transportation and hotels.
از شرکت کمک می‌خواهد تا حمل و نقل‌های زمینی و هتل‌ها را هماهنگ کند.
en-fa
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.
Minhas fontes também falaram sobre auditorias encenadas, em que equipes de fabricantes de dados inventam ou alteram documentos necessários para criar uma fachada de conformidade muito antes da chegada da FDA.
en-pt-br
One intrepid FDA investigator named Peter Baker figured out how to find the truth.
یک بازرس شجاع سازمان غذا و دارو به نام پیتر بیکر فهمید که چگونه حقیقت را تشخیص دهد.
en-fa
He ignored the data printouts, and he looked inside company computers.
Ele ignorava os dados impressos e analisava os computadores da empresa.
en-pt-br
When files were deleted, he found metadata revealing hidden tests.
وقتی فایل‌ها پاک شده بودند، فراداده‌ها را پیدا می‌کرد که تست‌های پنهان را آشکار می‌کردند.
en-fa
The companies were prescreening their drugs, figuring how to alter the official tests so they would meet FDA specifications.
Les entreprises passaient au crible leurs médicaments pour déterminer comment falsifier les tests officiels et les mettre en conformité aux spécifications de la FDA.
en-fr
As I said, this problem is more than a handful of bad actors.
Como eu disse, esse problema é mais do que um punhado de maus atores.
en-pt-br
Over four years, Peter Baker inspected 86 plants in India and China.
در طول چهار سال، پیتر بیکر ۸۶ کارخانه را هند و چین بازرسی کرد.
en-fa
He found evidence of fraud in 67 of them.
در ۶۷ مورد شواهدی از کلاه‌برداری کشف کرد.
en-fa
Wonder what happens to a batch of drugs that fails testing?
Si vous vous demandez ce qu'on fait d'un lot de médicaments non conformes,
en-fr
It should get thrown out.
它们本应被销毁。
en-zh-cn
Instead, low-cost plants usually sell them into poorly regulated markets that don't realize what they're getting, places like Africa, Southeast Asia and India itself.
Em vez disso, instalações de baixo custo os vendem em mercados mal regulamentados que não entendem o que estão recebendo, lugares como a África, o Sudeste da Ásia e a própria Índia.
en-pt-br
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。
en-zh-cn
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.
Nos países em desenvolvimento, este sistema corrupto inundou o mercado com tantos medicamentos ruins que pesquisadores de saúde pública os vinculam ao aumento de infecções resistentes a medicamentos.
en-pt-br
But criminal behavior by overseas companies is only half the problem.
Mas o comportamento criminoso de empresas estrangeiras é apenas metade do problema.
en-pt-br
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。
en-zh-cn
As a result, some American patients have gotten generic drugs with toxic impurities, unapproved ingredients, dangerous particulates or that are not bioequivalent.
La conséquence, c'est que certains patients américains ont reçu des médicaments génériques avec des impuretés toxiques, des ingrédients non approuvés, des particules dangereuses ou qui ne sont pas bioéquivalents.
en-fr
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。
en-zh-cn
Are there ways to solve this global problem?
» Y a-t-il des moyens de résoudre ce problème mondial ?
en-fr
Yes, there are.
Sim, existem.
en-pt-br
Solutions begin with recognizing that our current honor system for drug regulation is a relic of a bygone age.
As soluções começam com o reconhecimento de que nosso atual sistema de honra para regulamentação de medicamentos é uma relíquia de uma época passada.
en-pt-br
Science evolves. Medicine evolves.
A ciência, a medicina e a economia global evoluem.
en-pt-br
The global economy evolves.
全球经济在进步。
en-zh-cn
Shouldn't regulation evolve with them?
监管制度难道不应该也一起进步吗?
en-zh-cn
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。
en-zh-cn
Rigorous oversight means that regulators don't just look at printouts of data that may or may not be genuine.
Uma supervisão rigorosa significa que reguladores não observam apenas os dados que podem ou não ser genuínos.
en-pt-br
Effective solutions also depend on giving the average patient more information.
راه حل‌های موثر همچنین به اطلاعات دادن بیشتر به بیمار سطح متوسط وابسته است.
en-fa
We know where our breakfast cereal and our running shoes are manufactured.
Nous savons où sont produites nos céréales et nos chaussures de course.
en-fr
Why is it different for generic drugs?
为什么仿制药要区别对待?
en-zh-cn
Patients can do something else.
بیماران می‌توانند کار دیگری بکنند.
en-fa
They can tell their elected officials and consumer organizations to speak up just as loudly to demand quality as they do to demand access.
Ils peuvent dire à leurs élus et aux organisations de consommateurs d'élever la voix pour exiger la qualité autant que pour exiger un droit d'accès.
en-fr
Consumer organizations can do their members a great service by testing and ranking generics, just like cars and washing machines.
سازمان‌های حمایت از مشتری می‌توانند با آزمایش و رتبه‌بندی ژنریک‌ها خدماتی عالی عرضه کنند، درست مثل خودروها و ماشین‌های لباس‌شویی.
en-fa