A dose of reality about generic drugs
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0:01 - 0:05In 2008, I got an unusual phone call
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0:05 - 0:08from a guy named Joe Graedon.
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0:08 - 0:12Joe said he was getting flooded
with complaints from patients -
0:12 - 0:15who had recently been switched
to generic drugs. -
0:15 - 0:18Joe was a trained pharmacologist
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0:18 - 0:20and cohost of a radio show on NPR.
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0:21 - 0:27Patient after patient said their generics
were causing unwelcome side effects -
0:27 - 0:29or even relapses.
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0:29 - 0:31Joe believed the patients' claims.
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0:32 - 0:36But when he reported
these complaints to the FDA, -
0:36 - 0:40officials there argued,
"It was probably psychosomatic. -
0:40 - 0:44Patients are upset by pills
that look different from their old ones." -
0:46 - 0:48Joe didn't buy it.
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0:48 - 0:51He wanted someone
with investigative firepower -
0:51 - 0:53to dig into this,
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0:53 - 0:55and since I was
an investigative journalist, -
0:55 - 0:56he called me.
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0:58 - 1:00And then he posed a question
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1:00 - 1:03that I couldn't get out of my head:
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1:04 - 1:10"Katherine, what is wrong with the drugs?"
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1:13 - 1:18I spent the next 10 years
trying to track down the answer. -
1:19 - 1:21Our health care system relies on generics.
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1:21 - 1:23My family does, too.
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1:24 - 1:26But a decade of interviews,
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1:26 - 1:28meetings with whistleblowers,
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1:28 - 1:32on-the-ground reporting
across four continents -
1:32 - 1:34and thousands of confidential files --
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1:35 - 1:36from the FDA,
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1:36 - 1:38from generic drug companies
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1:38 - 1:40and from the courts --
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1:40 - 1:43all pointed me in the same direction:
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1:45 - 1:48a large number of generic
drug manufacturers -
1:48 - 1:51in certain overseas countries
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1:51 - 1:54are passing off substandard drugs
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1:56 - 1:58as legitimate generics
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1:58 - 2:00for profit.
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2:01 - 2:06They are deliberately flouting
FDA regulations and standards. -
2:07 - 2:11Basically, they are committing fraud.
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2:12 - 2:18In the process, they are risking
the health of patients around the world. -
2:18 - 2:21They may even be costing patient lives.
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2:23 - 2:26One leading company in India
has already shut down -
2:26 - 2:28because of this activity.
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2:28 - 2:30I wanted to know,
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2:30 - 2:33was that company an outlier
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2:34 - 2:36or the tip of the iceberg?
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2:37 - 2:40What I uncovered is disquieting,
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2:40 - 2:45and anyone who takes generic drugs
has the right to be deeply concerned. -
2:48 - 2:50If you're skeptical about any of this,
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2:51 - 2:52that's fair.
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2:52 - 2:57I saw generics as one of the world's
great public health innovations, -
2:57 - 3:00a giant win for patients worldwide.
-
3:01 - 3:04Ninety percent of our drugs
today are generic. -
3:04 - 3:09I knew generic HIV/AIDS medicine
had saved many lives in Africa. -
3:09 - 3:10Here at home,
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3:10 - 3:13programs from Medicare to Medicaid
and the Affordable Care Act -
3:13 - 3:15depended on them.
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3:15 - 3:18In an overpriced drug market,
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3:18 - 3:21generics were the heroic underdog.
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3:22 - 3:26But my biggest assumption was based
on the FDA's reassurance -
3:26 - 3:30that properly regulated generic drugs
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3:30 - 3:32are not only safe and effective,
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3:32 - 3:34but bioequivalent,
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3:34 - 3:37interchangeable with the brand
and with one another. -
3:38 - 3:40Well, that's true --
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3:41 - 3:45if companies follow the rules on paper.
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3:46 - 3:49But inside far-flung drug plants,
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3:49 - 3:54I uncovered a different,
unwritten set of rules. -
3:56 - 4:00I started my investigation
by focusing on the regulatory framework. -
4:01 - 4:04Right away, one fact surprised me:
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4:05 - 4:10the FDA does not vet manufacturer
applications by testing the drugs. -
4:10 - 4:14Instead, it reviews company data.
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4:16 - 4:21As the FDA's generic drugs director
actually told me, -
4:22 - 4:27"The approval system requires
the ethical behavior of the applicant. -
4:28 - 4:33Otherwise, the whole house
of cards will fall down." -
4:34 - 4:35Really?
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4:36 - 4:39It's the honor system?
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4:39 - 4:40(Laughter)
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4:42 - 4:47After nine months of digging,
I published my first article on generics. -
4:47 - 4:50I wrote about patients
who'd been switched to generic drugs -
4:50 - 4:52and suffered medical setbacks.
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4:53 - 4:54I quoted doctors
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4:54 - 4:59who questioned whether generics
really were bioequivalent to the brand. -
4:59 - 5:04A month later, I got an anonymous email
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5:04 - 5:09from someone calling himself
"Four Dollar Refill." -
5:10 - 5:11(Laughter)
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5:11 - 5:15Four dollars is what you'd pay
to fill a generic prescription at Walmart. -
5:17 - 5:20Four Dollar Refill worked inside
the generic drug industry. -
5:21 - 5:25He said if I really wanted
to uncover the problem, -
5:25 - 5:30I'd better go look where the majority
of our generic drugs are made: -
5:30 - 5:32in India and China.
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5:33 - 5:35Four Dollar Refill was right;
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5:35 - 5:3980 percent of the plants
making the active ingredient -
5:39 - 5:42for all our drugs, brand or generic,
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5:42 - 5:44are overseas,
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5:44 - 5:46mostly in China and India.
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5:47 - 5:51Any generic drug company
anywhere in the world -
5:51 - 5:56wanting approval to sell
its drugs into our market -
5:56 - 6:02has to follow elaborate rules
known as "Good Manufacturing Practices." -
6:03 - 6:07I decided to learn every detail
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6:07 - 6:10of how to manufacture
a legitimate generic drug. -
6:11 - 6:12At a top New Jersey lab,
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6:12 - 6:17I watched as technicians ran tests
on specialized machines -
6:17 - 6:20and used flasks that mimic
stomach conditions -
6:20 - 6:23to measure drug dissolution.
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6:24 - 6:27But one remarkable fact jumped out.
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6:28 - 6:31The lab banned Wite-Out --
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6:31 - 6:33correction fluid --
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6:33 - 6:35across its facility.
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6:36 - 6:42Under FDA rules, data serves
as the cornerstone of quality. -
6:42 - 6:45It has to be gathered
at each manufacturing step, -
6:45 - 6:46preserved
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6:46 - 6:48and shared with regulators.
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6:49 - 6:52Wite-Out was high-risk.
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6:52 - 6:53It invited tampering.
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6:55 - 7:00It was clear that for the FDA's
regulatory regime to succeed, -
7:00 - 7:05any company applying for approval
had to be ethical, -
7:05 - 7:08and its data had to be unaltered.
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7:09 - 7:11But what if neither was true?
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7:12 - 7:14What if the applicant was not ethical?
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7:15 - 7:19What if the data was not pristine?
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7:22 - 7:26I started to hear about a company
in India called Ranbaxy, -
7:26 - 7:28India's largest drug company,
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7:28 - 7:31one of its first successful multinationals
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7:32 - 7:36and one of the fastest-growing
generic suppliers to the US market. -
7:37 - 7:43A whistleblower was supplying
internal Ranbaxy documents to the FDA. -
7:44 - 7:46I got copies.
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7:49 - 7:53Deciphering the company's charts,
graphs and numbers -
7:53 - 7:56unveiled a shocking swindle.
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7:57 - 8:02They substituted unapproved,
lower-purity ingredients. -
8:03 - 8:08They invented documents
like standard operating procedures, -
8:08 - 8:11steaming them overnight
in a sauna-like room -
8:11 - 8:13to make them look old.
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8:14 - 8:19They conjured up three-, six-,
nine- and 18-month stability studies, -
8:21 - 8:23all generated on the same day.
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8:26 - 8:32Gradually, I was able to unearth the story
behind this regulatory nightmare. -
8:33 - 8:38In 2004, Ranbaxy hired a new
research and development director. -
8:39 - 8:42He suspected something was amiss.
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8:42 - 8:46He ordered a young engineer
named Dinesh Thakur -
8:46 - 8:49to study the data
in every drug application -
8:49 - 8:52to find out if it was real or fake.
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8:54 - 8:59Thakur eventually put together
a devastating PowerPoint -
9:00 - 9:06showing Ranbaxy had falsified data
for over 200 products -
9:06 - 9:09in more than 40 countries.
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9:10 - 9:13The new R and D director
showed this PowerPoint -
9:13 - 9:15to a subcommittee
of the board of directors. -
9:16 - 9:22The subcommittee ordered the report
and the laptop on which it was created -
9:22 - 9:23destroyed.
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9:24 - 9:27Then they forced Thakur
out of the company. -
9:27 - 9:29Thakur couldn't sleep,
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9:29 - 9:33thinking about Ranbaxy's
perilously bad drugs. -
9:34 - 9:37So he risked his life to alert the FDA.
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9:38 - 9:42After an eight-year investigation,
Ranbaxy pled guilty to seven felonies -
9:42 - 9:44for faking data.
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9:44 - 9:47An FDA consultant taught me
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9:47 - 9:50that just like cheap clothing
made in distant factories, -
9:50 - 9:53or "fast fashion," as she called it,
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9:53 - 9:55there were fast drugs, too,
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9:56 - 9:59made in pharmaceutical sweatshops overseas
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9:59 - 10:03with low-quality ingredients
and manufacturing shortcuts. -
10:03 - 10:07In Mexico City, I sat in a bar
with a whistleblower. -
10:07 - 10:12He handed me documents revealing
how the cost-cutting generic drug plant -
10:12 - 10:13where he worked
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10:13 - 10:16had knowingly released drug batches
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10:16 - 10:18that contained glass particles.
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10:19 - 10:21In Accra, capital of Ghana,
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10:21 - 10:26doctors explained how low-cost
Indian and Chinese medicine of all kinds -
10:26 - 10:29barely seemed to work,
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10:29 - 10:33even when they doubled
and tripled the doses. -
10:35 - 10:38In Mumbai, I met another whistleblower
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10:38 - 10:41from a company that
I had believed was ethical. -
10:42 - 10:46He sat there and described
the well-oiled machinery -
10:46 - 10:48of data manipulation
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10:48 - 10:52his company used to get
compromised drugs approved fast. -
10:53 - 10:56With tears running down
his cheeks, he said, -
10:56 - 10:58"What's going on in the industry
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10:58 - 11:02is very, very, very dirty."
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11:03 - 11:08In the US, a confidential source
who worked in the government -
11:08 - 11:10handed me a thumb drive
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11:11 - 11:15containing over 20,000
internal FDA documents. -
11:17 - 11:22The emails and memos revealed
how the agency's public health mission -- -
11:22 - 11:24protecting consumers --
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11:24 - 11:27often clashed with
its political mission -- -
11:27 - 11:31showing Congress a steady stream
of low-cost drug approvals. -
11:32 - 11:36I also learned about the FDA's
compromised inspection system -
11:36 - 11:38for overseas drug plants.
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11:38 - 11:42In the US, FDA investigators
arrive unannounced -
11:42 - 11:44to do surprise inspections.
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11:45 - 11:50But overseas, the FDA gives
manufacturing plants -
11:50 - 11:53months of advance notice.
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11:54 - 11:59It asks for the company's help
arranging ground transportation -
11:59 - 12:00and hotels.
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12:02 - 12:06My sources also talked
about staged inspections, -
12:06 - 12:11where teams of data fabricators
invent or alter needed documents -
12:11 - 12:16to create a facade of compliance
long before the FDA arrives. -
12:18 - 12:21One intrepid FDA investigator
named Peter Baker -
12:21 - 12:24figured out how to find the truth.
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12:24 - 12:26He ignored the data printouts,
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12:26 - 12:30and he looked inside company computers.
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12:31 - 12:33When files were deleted,
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12:33 - 12:37he found metadata
revealing hidden tests. -
12:38 - 12:41The companies were
prescreening their drugs, -
12:41 - 12:47figuring how to alter the official tests
so they would meet FDA specifications. -
12:47 - 12:52As I said, this problem is more than
a handful of bad actors. -
12:53 - 12:57Over four years,
Peter Baker inspected 86 plants -
12:57 - 12:59in India and China.
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13:00 - 13:04He found evidence of fraud in 67 of them.
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13:06 - 13:10Wonder what happens to a batch
of drugs that fails testing? -
13:10 - 13:12It should get thrown out.
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13:12 - 13:19Instead, low-cost plants usually sell them
into poorly regulated markets -
13:19 - 13:22that don't realize what they're getting,
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13:22 - 13:23places like Africa,
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13:23 - 13:25Southeast Asia
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13:25 - 13:27and India itself.
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13:29 - 13:34The overseas generics industry
calls this "dual-track production" -- -
13:35 - 13:37better drugs for some,
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13:38 - 13:40failed drugs for others.
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13:41 - 13:43In the developing world,
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13:43 - 13:46this corrupt system
has flooded the market -
13:46 - 13:49with so many bad drugs
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13:49 - 13:52that public health researchers link them
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13:52 - 13:55to the rise of drug-resistant infections.
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13:58 - 14:02But criminal behavior by overseas
companies is only half the problem. -
14:03 - 14:07Though some regulators apparently
don't realize they're being conned, -
14:07 - 14:13in the US, our regulators appear willing
to overlook transgressions -
14:13 - 14:17in order to continue green-lighting
low-cost medicine. -
14:17 - 14:21As a result, some American patients
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14:21 - 14:24have gotten generic drugs
with toxic impurities, -
14:24 - 14:26unapproved ingredients,
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14:26 - 14:29dangerous particulates
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14:29 - 14:31or that are not bioequivalent.
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14:31 - 14:34As the FDA investigator
Peter Baker put it, -
14:35 - 14:38if people actually understood,
-
14:38 - 14:41then nobody
would take these drugs. -
14:42 - 14:45Are there ways to solve
this global problem? -
14:45 - 14:46Yes, there are.
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14:47 - 14:49Solutions begin with recognizing
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14:49 - 14:53that our current honor system
for drug regulation -
14:53 - 14:56is a relic of a bygone age.
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14:56 - 14:59Science evolves. Medicine evolves.
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14:59 - 15:01The global economy evolves.
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15:01 - 15:04Shouldn't regulation evolve with them?
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15:05 - 15:08Only one approach can guarantee
quality generics: -
15:09 - 15:11rigorous oversight,
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15:11 - 15:17including unannounced inspections
and systematic testing of drugs. -
15:17 - 15:23Rigorous oversight means that regulators
don't just look at printouts of data -
15:23 - 15:25that may or may not be genuine.
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15:26 - 15:31Effective solutions also depend on giving
the average patient more information. -
15:32 - 15:36We know where our breakfast cereal
and our running shoes are manufactured. -
15:37 - 15:39Why is it different for generic drugs?
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15:39 - 15:41Patients can do something else.
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15:41 - 15:45They can tell their elected officials
and consumer organizations -
15:45 - 15:49to speak up just as loudly
to demand quality -
15:49 - 15:51as they do to demand access.
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15:52 - 15:56Consumer organizations can do
their members a great service -
15:56 - 15:58by testing and ranking generics,
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15:58 - 16:01just like cars and washing machines.
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16:02 - 16:05The big pharmacy chains
owe it to the public -
16:05 - 16:08to test the drugs they dispense.
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16:09 - 16:12A trip to the pharmacy
for affordable medicine -
16:12 - 16:14shouldn't come with a hidden cost.
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16:15 - 16:19Now is the time for all of us
who care about patient safety -
16:19 - 16:21to act on what we know.
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16:21 - 16:23Thank you.
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16:23 - 16:25(Applause)
- Title:
- A dose of reality about generic drugs
- Speaker:
- Katherine Eban
- Description:
-
Investigative journalist Katherine Eban set out to report on a seemingly straightforward question: Are generic drugs really identical to their brand-name counterparts? The answer sparked a decade of interviews, meetings with whistleblowers, on-the-ground reporting across four continents and digging into confidential FDA documents. In this alarming talk, she takes us inside overseas manufacturing plants and exposes the fraud behind many low-cost generic medicines.
- Video Language:
- English
- Team:
- closed TED
- Project:
- TEDTalks
- Duration:
- 16:39
Oliver Friedman edited English subtitles for A dose of reality about generic drugs | ||
Erin Gregory approved English subtitles for A dose of reality about generic drugs | ||
Camille Martínez accepted English subtitles for A dose of reality about generic drugs | ||
Erin Gregory edited English subtitles for A dose of reality about generic drugs | ||
Camille Martínez edited English subtitles for A dose of reality about generic drugs | ||
Camille Martínez edited English subtitles for A dose of reality about generic drugs | ||
Joseph Geni edited English subtitles for A dose of reality about generic drugs |