[Script Info]
Title: 
[Events]
Format: Layer, Start, End, Style, Name, MarginL, MarginR, MarginV, Effect, Text
Dialogue: 0,0:00:01.10,0:00:05.32,Default,,0000,0000,0000,,In 2008, I got an unusual phone call
Dialogue: 0,0:00:05.35,0:00:07.73,Default,,0000,0000,0000,,from a guy named Joe Graedon.
Dialogue: 0,0:00:08.30,0:00:11.87,Default,,0000,0000,0000,,Joe said he was getting flooded\Nwith complaints from patients
Dialogue: 0,0:00:11.89,0:00:14.97,Default,,0000,0000,0000,,who had recently been switched\Nto generic drugs.
Dialogue: 0,0:00:15.37,0:00:17.61,Default,,0000,0000,0000,,Joe was a trained pharmacologist
Dialogue: 0,0:00:17.64,0:00:20.45,Default,,0000,0000,0000,,and cohost of a radio show on NPR.
Dialogue: 0,0:00:21.02,0:00:26.65,Default,,0000,0000,0000,,Patient after patient said their generics\Nwere causing unwelcome side effects
Dialogue: 0,0:00:26.68,0:00:28.52,Default,,0000,0000,0000,,or even relapses.
Dialogue: 0,0:00:28.99,0:00:31.31,Default,,0000,0000,0000,,Joe believed the patients' claims.
Dialogue: 0,0:00:32.12,0:00:35.63,Default,,0000,0000,0000,,But when he reported\Nthese complaints to the FDA,
Dialogue: 0,0:00:35.66,0:00:40.09,Default,,0000,0000,0000,,officials there argued,\N"It was probably psychosomatic.
Dialogue: 0,0:00:40.11,0:00:44.48,Default,,0000,0000,0000,,Patients are upset by pills\Nthat look different from their old ones."
Dialogue: 0,0:00:45.78,0:00:47.59,Default,,0000,0000,0000,,Joe didn't buy it.
Dialogue: 0,0:00:47.61,0:00:50.98,Default,,0000,0000,0000,,He wanted someone\Nwith investigative firepower
Dialogue: 0,0:00:51.00,0:00:52.56,Default,,0000,0000,0000,,to dig into this,
Dialogue: 0,0:00:52.58,0:00:55.04,Default,,0000,0000,0000,,and since I was\Nan investigative journalist,
Dialogue: 0,0:00:55.07,0:00:56.46,Default,,0000,0000,0000,,he called me.
Dialogue: 0,0:00:57.77,0:01:00.14,Default,,0000,0000,0000,,And then he posed a question
Dialogue: 0,0:01:00.16,0:01:03.01,Default,,0000,0000,0000,,that I couldn't get out of my head:
Dialogue: 0,0:01:04.10,0:01:10.04,Default,,0000,0000,0000,,"Katherine, what is wrong with the drugs?"
Dialogue: 0,0:01:13.09,0:01:18.02,Default,,0000,0000,0000,,I spent the next 10 years\Ntrying to track down the answer.
Dialogue: 0,0:01:18.62,0:01:21.44,Default,,0000,0000,0000,,Our health care system relies on generics.
Dialogue: 0,0:01:21.46,0:01:23.37,Default,,0000,0000,0000,,My family does, too.
Dialogue: 0,0:01:24.39,0:01:26.14,Default,,0000,0000,0000,,But a decade of interviews,
Dialogue: 0,0:01:26.17,0:01:28.26,Default,,0000,0000,0000,,meetings with whistleblowers,
Dialogue: 0,0:01:28.28,0:01:32.04,Default,,0000,0000,0000,,on-the-ground reporting\Nacross four continents
Dialogue: 0,0:01:32.07,0:01:34.50,Default,,0000,0000,0000,,and thousands of confidential files --
Dialogue: 0,0:01:34.52,0:01:35.91,Default,,0000,0000,0000,,from the FDA,
Dialogue: 0,0:01:35.94,0:01:37.90,Default,,0000,0000,0000,,from generic drug companies
Dialogue: 0,0:01:37.93,0:01:39.93,Default,,0000,0000,0000,,and from the courts --
Dialogue: 0,0:01:39.96,0:01:43.38,Default,,0000,0000,0000,,all pointed me in the same direction:
Dialogue: 0,0:01:44.60,0:01:48.38,Default,,0000,0000,0000,,a large number of generic\Ndrug manufacturers
Dialogue: 0,0:01:48.40,0:01:50.73,Default,,0000,0000,0000,,in certain overseas countries
Dialogue: 0,0:01:51.49,0:01:54.44,Default,,0000,0000,0000,,are passing off substandard drugs
Dialogue: 0,0:01:55.53,0:01:58.19,Default,,0000,0000,0000,,as legitimate generics
Dialogue: 0,0:01:58.21,0:01:59.55,Default,,0000,0000,0000,,for profit.
Dialogue: 0,0:02:01.16,0:02:06.47,Default,,0000,0000,0000,,They are deliberately flouting\NFDA regulations and standards.
Dialogue: 0,0:02:07.12,0:02:11.23,Default,,0000,0000,0000,,Basically, they are committing fraud.
Dialogue: 0,0:02:12.46,0:02:17.63,Default,,0000,0000,0000,,In the process, they are risking\Nthe health of patients around the world.
Dialogue: 0,0:02:18.22,0:02:21.40,Default,,0000,0000,0000,,They may even be costing patient lives.
Dialogue: 0,0:02:22.63,0:02:26.04,Default,,0000,0000,0000,,One leading company in India\Nhas already shut down
Dialogue: 0,0:02:26.06,0:02:27.74,Default,,0000,0000,0000,,because of this activity.
Dialogue: 0,0:02:28.46,0:02:30.33,Default,,0000,0000,0000,,I wanted to know,
Dialogue: 0,0:02:30.35,0:02:32.96,Default,,0000,0000,0000,,was that company an outlier
Dialogue: 0,0:02:33.76,0:02:35.56,Default,,0000,0000,0000,,or the tip of the iceberg?
Dialogue: 0,0:02:37.05,0:02:39.75,Default,,0000,0000,0000,,What I uncovered is disquieting,
Dialogue: 0,0:02:39.77,0:02:45.47,Default,,0000,0000,0000,,and anyone who takes generic drugs\Nhas the right to be deeply concerned.
Dialogue: 0,0:02:47.80,0:02:50.49,Default,,0000,0000,0000,,If you're skeptical about any of this,
Dialogue: 0,0:02:50.51,0:02:52.03,Default,,0000,0000,0000,,that's fair.
Dialogue: 0,0:02:52.05,0:02:56.93,Default,,0000,0000,0000,,I saw generics as one of the world's\Ngreat public health innovations,
Dialogue: 0,0:02:56.95,0:02:59.85,Default,,0000,0000,0000,,a giant win for patients worldwide.
Dialogue: 0,0:03:00.51,0:03:03.79,Default,,0000,0000,0000,,Ninety percent of our drugs\Ntoday are generic.
Dialogue: 0,0:03:03.81,0:03:08.63,Default,,0000,0000,0000,,I knew generic HIV/AIDS medicine\Nhad saved many lives in Africa.
Dialogue: 0,0:03:09.09,0:03:10.26,Default,,0000,0000,0000,,Here at home,
Dialogue: 0,0:03:10.28,0:03:13.39,Default,,0000,0000,0000,,programs from Medicare to Medicaid\Nand the Affordable Care Act
Dialogue: 0,0:03:13.42,0:03:14.71,Default,,0000,0000,0000,,depended on them.
Dialogue: 0,0:03:15.35,0:03:17.53,Default,,0000,0000,0000,,In an overpriced drug market,
Dialogue: 0,0:03:17.56,0:03:20.53,Default,,0000,0000,0000,,generics were the heroic underdog.
Dialogue: 0,0:03:21.88,0:03:26.35,Default,,0000,0000,0000,,But my biggest assumption was based\Non the FDA's reassurance
Dialogue: 0,0:03:26.38,0:03:29.57,Default,,0000,0000,0000,,that properly regulated generic drugs
Dialogue: 0,0:03:29.59,0:03:32.32,Default,,0000,0000,0000,,are not only safe and effective,
Dialogue: 0,0:03:32.34,0:03:34.28,Default,,0000,0000,0000,,but bioequivalent,
Dialogue: 0,0:03:34.30,0:03:37.46,Default,,0000,0000,0000,,interchangeable with the brand\Nand with one another.
Dialogue: 0,0:03:38.48,0:03:40.04,Default,,0000,0000,0000,,Well, that's true --
Dialogue: 0,0:03:41.14,0:03:44.90,Default,,0000,0000,0000,,if companies follow the rules on paper.
Dialogue: 0,0:03:46.26,0:03:49.43,Default,,0000,0000,0000,,But inside far-flung drug plants,
Dialogue: 0,0:03:49.46,0:03:54.25,Default,,0000,0000,0000,,I uncovered a different,\Nunwritten set of rules.
Dialogue: 0,0:03:56.02,0:04:00.20,Default,,0000,0000,0000,,I started my investigation\Nby focusing on the regulatory framework.
Dialogue: 0,0:04:00.67,0:04:03.50,Default,,0000,0000,0000,,Right away, one fact surprised me:
Dialogue: 0,0:04:04.50,0:04:09.77,Default,,0000,0000,0000,,the FDA does not vet manufacturer\Napplications by testing the drugs.
Dialogue: 0,0:04:10.23,0:04:14.20,Default,,0000,0000,0000,,Instead, it reviews company data.
Dialogue: 0,0:04:16.45,0:04:20.73,Default,,0000,0000,0000,,As the FDA's generic drugs director\Nactually told me,
Dialogue: 0,0:04:21.72,0:04:27.33,Default,,0000,0000,0000,,"The approval system requires\Nthe ethical behavior of the applicant.
Dialogue: 0,0:04:28.18,0:04:33.16,Default,,0000,0000,0000,,Otherwise, the whole house\Nof cards will fall down."
Dialogue: 0,0:04:34.21,0:04:35.40,Default,,0000,0000,0000,,Really?
Dialogue: 0,0:04:36.08,0:04:38.74,Default,,0000,0000,0000,,It's the honor system?
Dialogue: 0,0:04:38.77,0:04:39.89,Default,,0000,0000,0000,,(Laughter)
Dialogue: 0,0:04:42.22,0:04:46.63,Default,,0000,0000,0000,,After nine months of digging,\NI published my first article on generics.
Dialogue: 0,0:04:47.01,0:04:50.36,Default,,0000,0000,0000,,I wrote about patients\Nwho'd been switched to generic drugs
Dialogue: 0,0:04:50.38,0:04:52.31,Default,,0000,0000,0000,,and suffered medical setbacks.
Dialogue: 0,0:04:52.100,0:04:54.17,Default,,0000,0000,0000,,I quoted doctors
Dialogue: 0,0:04:54.19,0:04:58.72,Default,,0000,0000,0000,,who questioned whether generics\Nreally were bioequivalent to the brand.
Dialogue: 0,0:04:59.27,0:05:03.98,Default,,0000,0000,0000,,A month later, I got an anonymous email
Dialogue: 0,0:05:04.01,0:05:08.75,Default,,0000,0000,0000,,from someone calling himself\N"Four Dollar Refill."
Dialogue: 0,0:05:09.73,0:05:11.00,Default,,0000,0000,0000,,(Laughter)
Dialogue: 0,0:05:11.42,0:05:15.37,Default,,0000,0000,0000,,Four dollars is what you'd pay\Nto fill a generic prescription at Walmart.
Dialogue: 0,0:05:16.62,0:05:20.38,Default,,0000,0000,0000,,Four Dollar Refill worked inside\Nthe generic drug industry.
Dialogue: 0,0:05:21.05,0:05:25.41,Default,,0000,0000,0000,,He said if I really wanted\Nto uncover the problem,
Dialogue: 0,0:05:25.44,0:05:29.54,Default,,0000,0000,0000,,I'd better go look where the majority\Nof our generic drugs are made:
Dialogue: 0,0:05:29.56,0:05:31.73,Default,,0000,0000,0000,,in India and China.
Dialogue: 0,0:05:33.08,0:05:35.25,Default,,0000,0000,0000,,Four Dollar Refill was right;
Dialogue: 0,0:05:35.27,0:05:38.78,Default,,0000,0000,0000,,80 percent of the plants\Nmaking the active ingredient
Dialogue: 0,0:05:38.80,0:05:41.84,Default,,0000,0000,0000,,for all our drugs, brand or generic,
Dialogue: 0,0:05:41.86,0:05:43.61,Default,,0000,0000,0000,,are overseas,
Dialogue: 0,0:05:43.63,0:05:45.88,Default,,0000,0000,0000,,mostly in China and India.
Dialogue: 0,0:05:47.43,0:05:51.33,Default,,0000,0000,0000,,Any generic drug company\Nanywhere in the world
Dialogue: 0,0:05:51.36,0:05:55.77,Default,,0000,0000,0000,,wanting approval to sell\Nits drugs into our market
Dialogue: 0,0:05:55.79,0:06:02.19,Default,,0000,0000,0000,,has to follow elaborate rules\Nknown as "Good Manufacturing Practices."
Dialogue: 0,0:06:03.25,0:06:06.72,Default,,0000,0000,0000,,I decided to learn every detail
Dialogue: 0,0:06:06.74,0:06:10.07,Default,,0000,0000,0000,,of how to manufacture\Na legitimate generic drug.
Dialogue: 0,0:06:10.80,0:06:12.29,Default,,0000,0000,0000,,At a top New Jersey lab,
Dialogue: 0,0:06:12.32,0:06:17.29,Default,,0000,0000,0000,,I watched as technicians ran tests\Non specialized machines
Dialogue: 0,0:06:17.32,0:06:20.44,Default,,0000,0000,0000,,and used flasks that mimic\Nstomach conditions
Dialogue: 0,0:06:20.47,0:06:22.59,Default,,0000,0000,0000,,to measure drug dissolution.
Dialogue: 0,0:06:23.57,0:06:27.06,Default,,0000,0000,0000,,But one remarkable fact jumped out.
Dialogue: 0,0:06:27.69,0:06:31.42,Default,,0000,0000,0000,,The lab banned Wite-Out --
Dialogue: 0,0:06:31.45,0:06:33.08,Default,,0000,0000,0000,,correction fluid --
Dialogue: 0,0:06:33.11,0:06:34.81,Default,,0000,0000,0000,,across its facility.
Dialogue: 0,0:06:36.46,0:06:41.60,Default,,0000,0000,0000,,Under FDA rules, data serves\Nas the cornerstone of quality.
Dialogue: 0,0:06:42.21,0:06:45.20,Default,,0000,0000,0000,,It has to be gathered\Nat each manufacturing step,
Dialogue: 0,0:06:45.22,0:06:46.37,Default,,0000,0000,0000,,preserved
Dialogue: 0,0:06:46.40,0:06:48.24,Default,,0000,0000,0000,,and shared with regulators.
Dialogue: 0,0:06:48.78,0:06:51.54,Default,,0000,0000,0000,,Wite-Out was high-risk.
Dialogue: 0,0:06:51.56,0:06:53.23,Default,,0000,0000,0000,,It invited tampering.
Dialogue: 0,0:06:55.00,0:07:00.47,Default,,0000,0000,0000,,It was clear that for the FDA's\Nregulatory regime to succeed,
Dialogue: 0,0:07:00.50,0:07:04.74,Default,,0000,0000,0000,,any company applying for approval\Nhad to be ethical,
Dialogue: 0,0:07:04.76,0:07:08.03,Default,,0000,0000,0000,,and its data had to be unaltered.
Dialogue: 0,0:07:09.46,0:07:11.03,Default,,0000,0000,0000,,But what if neither was true?
Dialogue: 0,0:07:11.61,0:07:14.02,Default,,0000,0000,0000,,What if the applicant was not ethical?
Dialogue: 0,0:07:15.22,0:07:19.23,Default,,0000,0000,0000,,What if the data was not pristine?
Dialogue: 0,0:07:21.86,0:07:25.80,Default,,0000,0000,0000,,I started to hear about a company\Nin India called Ranbaxy,
Dialogue: 0,0:07:25.82,0:07:28.11,Default,,0000,0000,0000,,India's largest drug company,
Dialogue: 0,0:07:28.13,0:07:31.48,Default,,0000,0000,0000,,one of its first successful multinationals
Dialogue: 0,0:07:31.50,0:07:36.03,Default,,0000,0000,0000,,and one of the fastest-growing\Ngeneric suppliers to the US market.
Dialogue: 0,0:07:37.16,0:07:42.92,Default,,0000,0000,0000,,A whistleblower was supplying\Ninternal Ranbaxy documents to the FDA.
Dialogue: 0,0:07:44.01,0:07:45.58,Default,,0000,0000,0000,,I got copies.
Dialogue: 0,0:07:48.58,0:07:53.20,Default,,0000,0000,0000,,Deciphering the company's charts,\Ngraphs and numbers
Dialogue: 0,0:07:53.22,0:07:56.39,Default,,0000,0000,0000,,unveiled a shocking swindle.
Dialogue: 0,0:07:57.41,0:08:02.01,Default,,0000,0000,0000,,They substituted unapproved,\Nlower-purity ingredients.
Dialogue: 0,0:08:03.20,0:08:07.53,Default,,0000,0000,0000,,They invented documents\Nlike standard operating procedures,
Dialogue: 0,0:08:07.55,0:08:11.38,Default,,0000,0000,0000,,steaming them overnight\Nin a sauna-like room
Dialogue: 0,0:08:11.40,0:08:13.17,Default,,0000,0000,0000,,to make them look old.
Dialogue: 0,0:08:14.36,0:08:19.43,Default,,0000,0000,0000,,They conjured up three-, six-,\Nnine- and 18-month stability studies,
Dialogue: 0,0:08:20.53,0:08:23.49,Default,,0000,0000,0000,,all generated on the same day.
Dialogue: 0,0:08:25.57,0:08:31.93,Default,,0000,0000,0000,,Gradually, I was able to unearth the story\Nbehind this regulatory nightmare.
Dialogue: 0,0:08:33.10,0:08:38.15,Default,,0000,0000,0000,,In 2004, Ranbaxy hired a new\Nresearch and development director.
Dialogue: 0,0:08:39.12,0:08:41.60,Default,,0000,0000,0000,,He suspected something was amiss.
Dialogue: 0,0:08:42.38,0:08:45.80,Default,,0000,0000,0000,,He ordered a young engineer\Nnamed Dinesh Thakur
Dialogue: 0,0:08:45.82,0:08:49.22,Default,,0000,0000,0000,,to study the data\Nin every drug application
Dialogue: 0,0:08:49.24,0:08:52.02,Default,,0000,0000,0000,,to find out if it was real or fake.
Dialogue: 0,0:08:53.69,0:08:58.86,Default,,0000,0000,0000,,Thakur eventually put together\Na devastating PowerPoint
Dialogue: 0,0:08:59.67,0:09:06.03,Default,,0000,0000,0000,,showing Ranbaxy had falsified data\Nfor over 200 products
Dialogue: 0,0:09:06.05,0:09:08.80,Default,,0000,0000,0000,,in more than 40 countries.
Dialogue: 0,0:09:09.99,0:09:12.91,Default,,0000,0000,0000,,The new R and D director\Nshowed this PowerPoint
Dialogue: 0,0:09:12.93,0:09:15.48,Default,,0000,0000,0000,,to a subcommittee\Nof the board of directors.
Dialogue: 0,0:09:16.17,0:09:21.84,Default,,0000,0000,0000,,The subcommittee ordered the report\Nand the laptop on which it was created
Dialogue: 0,0:09:21.87,0:09:23.11,Default,,0000,0000,0000,,destroyed.
Dialogue: 0,0:09:24.02,0:09:26.64,Default,,0000,0000,0000,,Then they forced Thakur\Nout of the company.
Dialogue: 0,0:09:27.43,0:09:29.21,Default,,0000,0000,0000,,Thakur couldn't sleep,
Dialogue: 0,0:09:29.24,0:09:33.28,Default,,0000,0000,0000,,thinking about Ranbaxy's\Nperilously bad drugs.
Dialogue: 0,0:09:33.88,0:09:36.89,Default,,0000,0000,0000,,So he risked his life to alert the FDA.
Dialogue: 0,0:09:37.100,0:09:42.34,Default,,0000,0000,0000,,After an eight-year investigation,\NRanbaxy pled guilty to seven felonies
Dialogue: 0,0:09:42.36,0:09:43.62,Default,,0000,0000,0000,,for faking data.
Dialogue: 0,0:09:44.27,0:09:46.54,Default,,0000,0000,0000,,An FDA consultant taught me
Dialogue: 0,0:09:46.56,0:09:50.34,Default,,0000,0000,0000,,that just like cheap clothing\Nmade in distant factories,
Dialogue: 0,0:09:50.36,0:09:53.36,Default,,0000,0000,0000,,or "fast fashion," as she called it,
Dialogue: 0,0:09:53.39,0:09:55.50,Default,,0000,0000,0000,,there were fast drugs, too,
Dialogue: 0,0:09:55.52,0:09:58.62,Default,,0000,0000,0000,,made in pharmaceutical sweatshops overseas
Dialogue: 0,0:09:58.64,0:10:02.74,Default,,0000,0000,0000,,with low-quality ingredients\Nand manufacturing shortcuts.
Dialogue: 0,0:10:03.36,0:10:07.20,Default,,0000,0000,0000,,In Mexico City, I sat in a bar\Nwith a whistleblower.
Dialogue: 0,0:10:07.23,0:10:11.54,Default,,0000,0000,0000,,He handed me documents revealing\Nhow the cost-cutting generic drug plant
Dialogue: 0,0:10:11.56,0:10:12.87,Default,,0000,0000,0000,,where he worked
Dialogue: 0,0:10:12.90,0:10:15.55,Default,,0000,0000,0000,,had knowingly released drug batches
Dialogue: 0,0:10:15.57,0:10:18.36,Default,,0000,0000,0000,,that contained glass particles.
Dialogue: 0,0:10:18.76,0:10:21.34,Default,,0000,0000,0000,,In Accra, capital of Ghana,
Dialogue: 0,0:10:21.36,0:10:26.37,Default,,0000,0000,0000,,doctors explained how low-cost\NIndian and Chinese medicine of all kinds
Dialogue: 0,0:10:26.39,0:10:28.70,Default,,0000,0000,0000,,barely seemed to work,
Dialogue: 0,0:10:28.72,0:10:33.48,Default,,0000,0000,0000,,even when they doubled\Nand tripled the doses.
Dialogue: 0,0:10:34.63,0:10:37.91,Default,,0000,0000,0000,,In Mumbai, I met another whistleblower
Dialogue: 0,0:10:37.94,0:10:41.06,Default,,0000,0000,0000,,from a company that\NI had believed was ethical.
Dialogue: 0,0:10:41.76,0:10:45.65,Default,,0000,0000,0000,,He sat there and described\Nthe well-oiled machinery
Dialogue: 0,0:10:45.67,0:10:47.51,Default,,0000,0000,0000,,of data manipulation
Dialogue: 0,0:10:47.53,0:10:51.72,Default,,0000,0000,0000,,his company used to get\Ncompromised drugs approved fast.
Dialogue: 0,0:10:52.54,0:10:56.06,Default,,0000,0000,0000,,With tears running down\Nhis cheeks, he said,
Dialogue: 0,0:10:56.08,0:10:58.05,Default,,0000,0000,0000,,"What's going on in the industry
Dialogue: 0,0:10:58.08,0:11:01.60,Default,,0000,0000,0000,,is very, very, very dirty."
Dialogue: 0,0:11:02.79,0:11:07.63,Default,,0000,0000,0000,,In the US, a confidential source\Nwho worked in the government
Dialogue: 0,0:11:07.66,0:11:09.94,Default,,0000,0000,0000,,handed me a thumb drive
Dialogue: 0,0:11:10.78,0:11:15.38,Default,,0000,0000,0000,,containing over 20,000\Ninternal FDA documents.
Dialogue: 0,0:11:17.08,0:11:22.01,Default,,0000,0000,0000,,The emails and memos revealed\Nhow the agency's public health mission --
Dialogue: 0,0:11:22.03,0:11:23.78,Default,,0000,0000,0000,,protecting consumers --
Dialogue: 0,0:11:23.81,0:11:26.78,Default,,0000,0000,0000,,often clashed with\Nits political mission --
Dialogue: 0,0:11:26.81,0:11:30.99,Default,,0000,0000,0000,,showing Congress a steady stream\Nof low-cost drug approvals.
Dialogue: 0,0:11:32.02,0:11:35.91,Default,,0000,0000,0000,,I also learned about the FDA's\Ncompromised inspection system
Dialogue: 0,0:11:35.93,0:11:38.20,Default,,0000,0000,0000,,for overseas drug plants.
Dialogue: 0,0:11:38.22,0:11:42.05,Default,,0000,0000,0000,,In the US, FDA investigators\Narrive unannounced
Dialogue: 0,0:11:42.07,0:11:43.93,Default,,0000,0000,0000,,to do surprise inspections.
Dialogue: 0,0:11:44.62,0:11:50.27,Default,,0000,0000,0000,,But overseas, the FDA gives\Nmanufacturing plants
Dialogue: 0,0:11:50.30,0:11:52.90,Default,,0000,0000,0000,,months of advance notice.
Dialogue: 0,0:11:53.67,0:11:58.71,Default,,0000,0000,0000,,It asks for the company's help\Narranging ground transportation
Dialogue: 0,0:11:58.73,0:12:00.16,Default,,0000,0000,0000,,and hotels.
Dialogue: 0,0:12:01.92,0:12:06.22,Default,,0000,0000,0000,,My sources also talked\Nabout staged inspections,
Dialogue: 0,0:12:06.24,0:12:11.05,Default,,0000,0000,0000,,where teams of data fabricators\Ninvent or alter needed documents
Dialogue: 0,0:12:11.08,0:12:15.97,Default,,0000,0000,0000,,to create a facade of compliance\Nlong before the FDA arrives.
Dialogue: 0,0:12:17.68,0:12:21.35,Default,,0000,0000,0000,,One intrepid FDA investigator\Nnamed Peter Baker
Dialogue: 0,0:12:21.38,0:12:23.54,Default,,0000,0000,0000,,figured out how to find the truth.
Dialogue: 0,0:12:23.98,0:12:26.39,Default,,0000,0000,0000,,He ignored the data printouts,
Dialogue: 0,0:12:26.42,0:12:30.01,Default,,0000,0000,0000,,and he looked inside company computers.
Dialogue: 0,0:12:31.17,0:12:33.36,Default,,0000,0000,0000,,When files were deleted,
Dialogue: 0,0:12:33.38,0:12:37.50,Default,,0000,0000,0000,,he found metadata\Nrevealing hidden tests.
Dialogue: 0,0:12:37.92,0:12:41.36,Default,,0000,0000,0000,,The companies were\Nprescreening their drugs,
Dialogue: 0,0:12:41.38,0:12:46.66,Default,,0000,0000,0000,,figuring how to alter the official tests\Nso they would meet FDA specifications.
Dialogue: 0,0:12:47.36,0:12:52.50,Default,,0000,0000,0000,,As I said, this problem is more than\Na handful of bad actors.
Dialogue: 0,0:12:52.96,0:12:57.42,Default,,0000,0000,0000,,Over four years,\NPeter Baker inspected 86 plants
Dialogue: 0,0:12:57.45,0:12:59.10,Default,,0000,0000,0000,,in India and China.
Dialogue: 0,0:12:59.59,0:13:04.01,Default,,0000,0000,0000,,He found evidence of fraud in 67 of them.
Dialogue: 0,0:13:06.11,0:13:10.06,Default,,0000,0000,0000,,Wonder what happens to a batch\Nof drugs that fails testing?
Dialogue: 0,0:13:10.08,0:13:11.67,Default,,0000,0000,0000,,It should get thrown out.
Dialogue: 0,0:13:12.31,0:13:18.93,Default,,0000,0000,0000,,Instead, low-cost plants usually sell them\Ninto poorly regulated markets
Dialogue: 0,0:13:18.95,0:13:21.59,Default,,0000,0000,0000,,that don't realize what they're getting,
Dialogue: 0,0:13:21.62,0:13:23.41,Default,,0000,0000,0000,,places like Africa,
Dialogue: 0,0:13:23.43,0:13:25.41,Default,,0000,0000,0000,,Southeast Asia
Dialogue: 0,0:13:25.43,0:13:27.21,Default,,0000,0000,0000,,and India itself.
Dialogue: 0,0:13:29.30,0:13:34.31,Default,,0000,0000,0000,,The overseas generics industry\Ncalls this "dual-track production" --
Dialogue: 0,0:13:35.33,0:13:36.95,Default,,0000,0000,0000,,better drugs for some,
Dialogue: 0,0:13:37.82,0:13:40.02,Default,,0000,0000,0000,,failed drugs for others.
Dialogue: 0,0:13:41.44,0:13:42.80,Default,,0000,0000,0000,,In the developing world,
Dialogue: 0,0:13:42.82,0:13:45.70,Default,,0000,0000,0000,,this corrupt system\Nhas flooded the market
Dialogue: 0,0:13:45.72,0:13:48.91,Default,,0000,0000,0000,,with so many bad drugs
Dialogue: 0,0:13:48.94,0:13:52.13,Default,,0000,0000,0000,,that public health researchers link them
Dialogue: 0,0:13:52.16,0:13:55.44,Default,,0000,0000,0000,,to the rise of drug-resistant infections.
Dialogue: 0,0:13:58.00,0:14:02.20,Default,,0000,0000,0000,,But criminal behavior by overseas\Ncompanies is only half the problem.
Dialogue: 0,0:14:02.66,0:14:07.16,Default,,0000,0000,0000,,Though some regulators apparently\Ndon't realize they're being conned,
Dialogue: 0,0:14:07.18,0:14:13.42,Default,,0000,0000,0000,,in the US, our regulators appear willing\Nto overlook transgressions
Dialogue: 0,0:14:13.44,0:14:16.79,Default,,0000,0000,0000,,in order to continue green-lighting\Nlow-cost medicine.
Dialogue: 0,0:14:17.46,0:14:20.80,Default,,0000,0000,0000,,As a result, some American patients
Dialogue: 0,0:14:20.83,0:14:24.12,Default,,0000,0000,0000,,have gotten generic drugs\Nwith toxic impurities,
Dialogue: 0,0:14:24.15,0:14:26.44,Default,,0000,0000,0000,,unapproved ingredients,
Dialogue: 0,0:14:26.46,0:14:28.51,Default,,0000,0000,0000,,dangerous particulates
Dialogue: 0,0:14:28.53,0:14:30.57,Default,,0000,0000,0000,,or that are not bioequivalent.
Dialogue: 0,0:14:31.28,0:14:34.28,Default,,0000,0000,0000,,As the FDA investigator\NPeter Baker put it,
Dialogue: 0,0:14:34.89,0:14:37.58,Default,,0000,0000,0000,,if people actually understood,
Dialogue: 0,0:14:38.37,0:14:40.74,Default,,0000,0000,0000,,then nobody\Nwould take these drugs.
Dialogue: 0,0:14:41.80,0:14:44.82,Default,,0000,0000,0000,,Are there ways to solve\Nthis global problem?
Dialogue: 0,0:14:44.84,0:14:46.29,Default,,0000,0000,0000,,Yes, there are.
Dialogue: 0,0:14:47.00,0:14:49.37,Default,,0000,0000,0000,,Solutions begin with recognizing
Dialogue: 0,0:14:49.40,0:14:53.02,Default,,0000,0000,0000,,that our current honor system\Nfor drug regulation
Dialogue: 0,0:14:53.04,0:14:55.100,Default,,0000,0000,0000,,is a relic of a bygone age.
Dialogue: 0,0:14:56.02,0:14:58.94,Default,,0000,0000,0000,,Science evolves. Medicine evolves.
Dialogue: 0,0:14:58.97,0:15:01.36,Default,,0000,0000,0000,,The global economy evolves.
Dialogue: 0,0:15:01.39,0:15:04.18,Default,,0000,0000,0000,,Shouldn't regulation evolve with them?
Dialogue: 0,0:15:04.89,0:15:08.41,Default,,0000,0000,0000,,Only one approach can guarantee\Nquality generics:
Dialogue: 0,0:15:09.36,0:15:11.21,Default,,0000,0000,0000,,rigorous oversight,
Dialogue: 0,0:15:11.23,0:15:16.57,Default,,0000,0000,0000,,including unannounced inspections\Nand systematic testing of drugs.
Dialogue: 0,0:15:17.27,0:15:23.08,Default,,0000,0000,0000,,Rigorous oversight means that regulators\Ndon't just look at printouts of data
Dialogue: 0,0:15:23.10,0:15:25.08,Default,,0000,0000,0000,,that may or may not be genuine.
Dialogue: 0,0:15:26.02,0:15:31.31,Default,,0000,0000,0000,,Effective solutions also depend on giving\Nthe average patient more information.
Dialogue: 0,0:15:32.07,0:15:36.16,Default,,0000,0000,0000,,We know where our breakfast cereal\Nand our running shoes are manufactured.
Dialogue: 0,0:15:36.69,0:15:39.38,Default,,0000,0000,0000,,Why is it different for generic drugs?
Dialogue: 0,0:15:39.40,0:15:41.07,Default,,0000,0000,0000,,Patients can do something else.
Dialogue: 0,0:15:41.09,0:15:44.95,Default,,0000,0000,0000,,They can tell their elected officials\Nand consumer organizations
Dialogue: 0,0:15:44.97,0:15:48.93,Default,,0000,0000,0000,,to speak up just as loudly\Nto demand quality
Dialogue: 0,0:15:48.95,0:15:51.42,Default,,0000,0000,0000,,as they do to demand access.
Dialogue: 0,0:15:52.18,0:15:56.07,Default,,0000,0000,0000,,Consumer organizations can do\Ntheir members a great service
Dialogue: 0,0:15:56.09,0:15:58.19,Default,,0000,0000,0000,,by testing and ranking generics,
Dialogue: 0,0:15:58.21,0:16:01.20,Default,,0000,0000,0000,,just like cars and washing machines.
Dialogue: 0,0:16:01.94,0:16:05.32,Default,,0000,0000,0000,,The big pharmacy chains\Nowe it to the public
Dialogue: 0,0:16:05.34,0:16:07.84,Default,,0000,0000,0000,,to test the drugs they dispense.
Dialogue: 0,0:16:08.57,0:16:11.51,Default,,0000,0000,0000,,A trip to the pharmacy\Nfor affordable medicine
Dialogue: 0,0:16:11.53,0:16:14.32,Default,,0000,0000,0000,,shouldn't come with a hidden cost.
Dialogue: 0,0:16:14.77,0:16:19.16,Default,,0000,0000,0000,,Now is the time for all of us\Nwho care about patient safety
Dialogue: 0,0:16:19.19,0:16:21.27,Default,,0000,0000,0000,,to act on what we know.
Dialogue: 0,0:16:21.30,0:16:22.51,Default,,0000,0000,0000,,Thank you.
Dialogue: 0,0:16:22.53,0:16:25.00,Default,,0000,0000,0000,,(Applause)