Speaker 1: Who can forget Martin Shakrelli, who became one of America's
Speaker 1: favorite villains when he hiked the price of dryprim, a
Speaker 1: drug that people desperately need in order to live, by
Speaker 1: five thousand percent. After that came Valiant, the once high
Speaker 1: flying pharmaceutical company that ran the same sort of racket.
Speaker 1: Those two scandals put the spotlight on an increasingly big
Speaker 1: and political problem in the United States, the alarmingly high
Speaker 1: cost of pharmaceuticals. Americans spend more under prescriptions than anyone
Speaker 1: else in the world, two to four times as much
Speaker 1: for some commonly used drugs. According to JP Morgan, the
Speaker 1: average American spends over a thousand dollars a year on medication,
Speaker 1: an inflation adjusted increase of elevenfold since nineteen sixty According
Speaker 1: to the Atlantic spoil Our Alert, this is not, as
Speaker 1: one might logically assume, because we are getting sicker. Even
Speaker 1: President Trump is taking this on. About a year ago,
Speaker 1: Trump promised, you'll be seeing drug prices falling very substantially
Speaker 1: in the not too distant future. It's going to be beautiful.
Speaker 1: The beauty hasn't quite manifested itself yet, but that's another story.
Speaker 1: The market for pharmaceuticals is by no means a free one.
Speaker 1: Everything about it is shaped by laws, and patent laws
Speaker 1: are the reason the prices in the United States are
Speaker 1: so much higher than in the rest of the world.
Speaker 1: Here's how it works. Drug companies get legal protections to
Speaker 1: make huge profits for a few years to reward the
Speaker 1: risk of investment in clinical trials. The offset is supposed
Speaker 1: to be the generic drug industry, which are essentially cheaper
Speaker 1: copies of brand named pharmaceuticals. The artificial monopoly period ends
Speaker 1: after seven years. Generic manufacturers move in and create supposedly
Speaker 1: identical products, thereby making important drugs available at reasonable costs
Speaker 1: to most Americans. Case in point, Viser's cholesterol reducing drug
Speaker 1: Libatore was one of the best selling drugs of all time.
Speaker 1: Then it went generic in two eleven and the price plummeted.
Speaker 1: In the case of your average person struggling with high cholesterol,
Speaker 1: this is really good news. According to the Atlantic monopoly
Speaker 1: expirations have saved buyers about sixty five billion dollars over
Speaker 1: the past five years. The generic market accounts for an
Speaker 1: ever greater percentage of prescriptions, and the Trump administration and
Speaker 1: the Obama administration before that have made continued efforts to
Speaker 1: expand its share. In other words, without generic drugs, drug
Speaker 1: prices would not just be a problem, but for some
Speaker 1: people literally a killer. Which is why Katherine Eban's new book,
Speaker 1: Bottle of Lies is so frightening, because, as her book
Speaker 1: tells it, we cannot trust generic drugs, the very thing
Speaker 1: that is making our medicines at least semi affordable. Her book,
Speaker 1: in a sense, is a story of globalization. Because much
Speaker 1: of the manufacturing of these drugs is now done in
Speaker 1: India and China, our regulatory system is utterly unable to
Speaker 1: police global manufacturing. Yet Eban says that in the United States,
Speaker 1: imports from India now make up forty percent of all
Speaker 1: generics used, and eighty percent of the active ingredients used
Speaker 1: in both generic and brand name medications come from India
Speaker 1: and China. Her book is also the incredibly gripping story
Speaker 1: of a whistleblower who worked at one of India's largest
Speaker 1: generic drug manufacturers, called Rambaxi Laboratories. She writes that before
Speaker 1: he'd arrived at Rambaxie, he assumed that a pill was
Speaker 1: a pill manufactured identically for all the regions of the world,
Speaker 1: so did I until I read Catherine's book. Catherine is
Speaker 1: a longtime investigative reporter who focuses on public health and
Speaker 1: homeland security. She's written for Fortune, Vanity Fair, and many
Speaker 1: other places. We first met years ago at Fortune and
Speaker 1: bonded over the fact that we both have two daughters
Speaker 1: and large dogs, and I'm delighted to have her here today.
Speaker 1: We have to begin with Gandhi. What's his connection to
Speaker 1: the generic drug industry. It was in World War Two
Speaker 1: and the Indians were trying to gain their freedom from
Speaker 1: the British and they needed pharmaceuticals for the Indian army,
Speaker 1: and the British couldn't supply them anymore because supplies from
Speaker 1: Europe had collapsed. Gandhi had actually gone to a fellow
Speaker 1: named Hamid who ran a company called Sipla, and said
Speaker 1: to him, you'll be helping the resistance campaign against the
Speaker 1: British and our freedom if you can step up production
Speaker 1: of pharmaceuticals for the Indian army. He did, Sipila became
Speaker 1: the largest manufacturer of active ingredients in India. The Indians,
Speaker 1: of course, won their freedom from the British and so
Speaker 1: began the Golden Age of Indian pharma. And then there's
Speaker 1: this other moment that gives the Indian generic drug manufacturing
Speaker 1: industry huge legitimacy, and that's Bill Clinton. In the battle
Speaker 1: over AIDS drugs, right, Hamid's son Yusuf Hamid, known as Yuku,
Speaker 1: took over the operations of SIPLA and was just hauled
Speaker 1: by the AIDS epidemic and the deaths of thousands and
Speaker 1: thousands of Africans. Uku Hamid was contacted by activists in
Speaker 1: the West who asked him could he manufacture the HIV
Speaker 1: AIDS cocktail more cheaply, and he ultimately put forth the
Speaker 1: number of a dollar a day, which was a stunning
Speaker 1: decrease from where the drug was priced, right right, a
Speaker 1: stunning decrease, and that really was a game changer. So
Speaker 1: ultimately the brand name companies previously had refused to waive
Speaker 1: their patents now agreed to waive their patents. But Bill
Speaker 1: Clinton then came forward through his foundation and got the
Speaker 1: Indian industry to agree to drop the prices even further
Speaker 1: to thirty eight cents a day, and got African governments
Speaker 1: organized to buy in bulk, and so Indian pharma was
Speaker 1: really viewed as the savior of so many AIDS patients
Speaker 1: around the world. I think you write in your book,
Speaker 1: which I love, if Indians could make affordable medicine good
Speaker 1: enough to be approved by American regulators, then the drugs
Speaker 1: were good enough for Americans to take too. So it's
Speaker 1: this pivotal moment absolutely. I mean, the AIDS crisis really
Speaker 1: did it because in order to make sure that US
Speaker 1: taxpayers we were paying for the drugs, were paying for
Speaker 1: good quality drugs, there was a demand for FDA approval
Speaker 1: of them. And if they were good enough to be
Speaker 1: approved by our own regulators, then they were good enough
Speaker 1: for Americans to take to Let's talk a little bit
Speaker 1: about the FDA and this role that the FDA plays
Speaker 1: and regulating drugs and the role that FDA inspectors play.
Speaker 1: I found that those people fascinating characters in your book.
Speaker 1: Any plant anywhere in the world that exports to the
Speaker 1: US is required to undergo FDA inspection and has to
Speaker 1: meet standards called current Good Manufacturing Practices, and those stipulate
Speaker 1: all of the controls, the transparency, and the documentation requirements
Speaker 1: for manufacturing plants. They're really very detailed standards, and those
Speaker 1: plants are subject to inspection by FDA investigators. So those
Speaker 1: are the people who come in and ensure that the
Speaker 1: plants are in compliance and operating in a state of control.
Speaker 1: And how did you start getting to know these people?
Speaker 1: As I was reporting, I became aware of the incredible
Speaker 1: inspections of Peter Baker. He was a young FDA investigator
Speaker 1: who had become famous or notorious really around the world
Speaker 1: because he scared people. He scared the industry, and he
Speaker 1: had forged a really novel system of inspection, which is,
Speaker 1: instead of walking around the manufacturing floor and looking at
Speaker 1: paper records or requesting documentation, he started going into the
Speaker 1: computer systems of these manufacturing plants and looking at the
Speaker 1: testing data in those plants. And this was new. This
Speaker 1: wasn't something the FDA had been doing before, right, seems shocking. Yeah,
Speaker 1: as one person had said to me, you know, they're
Speaker 1: using their thinking from the early two thousands to be
Speaker 1: inspecting plants in two thousand and fifteen. I mean, it
Speaker 1: was just this idea that if you print something out
Speaker 1: and you have data printed out, that that's the only
Speaker 1: documentation that exists, whereas, of course inside of the computer
Speaker 1: systems anything is really possible. You say that this book
Speaker 1: began in particular because of a puzzle you couldn't solve.
Speaker 1: Explained that it was two thousand and eight and I
Speaker 1: got a call from a radio show host named Joe Graden,
Speaker 1: who hosts a show called The People's Pharmacy. He had
Speaker 1: been hearing from listeners who had been switched from brand
Speaker 1: drugs to generics and had symptoms suddenly that were really troubling,
Speaker 1: or they were stable and then they weren't stable anymore.
Speaker 1: And what got him about it, and he's a pharmacologist
Speaker 1: by training, is that the complaints were very similar and
Speaker 1: even centered around certain drugs, drugs with time release mechanisms.
Speaker 1: He thought it was very serious what he was hearing,
Speaker 1: so he took these complaints to the FDA, and officials
Speaker 1: there basically told him, we think it's psychosomatic. It's in
Speaker 1: their heads because once they're switched to a new drug,
Speaker 1: the color changes, the shape changes. All those crazy patients,
Speaker 1: all those crazy patients. That didn't sound right to him,
Speaker 1: And so at the point that he called me in
Speaker 1: two thousand and eight, he basically said, I think we
Speaker 1: need somebody with investigative firepower, as he put it, to
Speaker 1: look into this. And he asked me this question, what
Speaker 1: is wrong with the drugs? So I began looking into it,
Speaker 1: and I started where he pointed me, with the patients.
Speaker 1: So I interviewed patients, I interviewed doctors. You know, it
Speaker 1: was easy to document what he had been listening to,
Speaker 1: which is patients who had been sent on crazy medical
Speaker 1: odyssees because they had these symptoms, only to realize, you know,
Speaker 1: after nobody could help them that wait a second, and
Speaker 1: the symptoms started right after they were switched to a generic.
Speaker 1: And then I found doctors who were really concerned, particularly
Speaker 1: who prescribe what are called narrow therapeutic index drugs, So
Speaker 1: these are drugs that require very precise dosing. And they
Speaker 1: could see that these medication switches were sent to the
Speaker 1: pharmacy or switched from brand to generic or from generic
Speaker 1: to generic. They could see that there was really a
Speaker 1: problem there, but of course they didn't know why. And
Speaker 1: these are not doctors anywhere. These were some of the
Speaker 1: nation's most prestigious healthcare organizations. Yes, these are serious doctors
Speaker 1: treating seriously ill patients who were concerned. I really recognized
Speaker 1: as I was reporting this article. My first one ran
Speaker 1: in Self magazine. It was very unsatisfying because even if
Speaker 1: I prove YEP patients are sick, YEP doctors are puzzled,
Speaker 1: it doesn't answer this fundamental question, what is wrong with
Speaker 1: the drugs. So as I was reporting that article, I
Speaker 1: learned about a company I'd never heard of before called
Speaker 1: ram Backsey, and this is India's largest drug company. In India,
Speaker 1: it was a household name. Everybody knew. Rambacksey was a
Speaker 1: source of great national pride and had been one of
Speaker 1: the first multinational companies. And so I found out that
Speaker 1: the FDA was investigating this company for possible data fraud,
Speaker 1: which sounds somewhat benign on the surface, data fraud, but
Speaker 1: it's not at all right. I was about to learn
Speaker 1: a whole lot about data fraud. But what really moved
Speaker 1: things forward is that after my self article ran I
Speaker 1: was contacted by a whistleblower who identified himself under the
Speaker 1: name four dollar Refill. So four dollar refill is it's
Speaker 1: what you pay if you fill a generic prescription at Walmart.
Speaker 1: It's like the cheap refill. Interesting we're all generally happy
Speaker 1: to get. And I've got into a dialogue with him
Speaker 1: and he really began pointing me thousands of miles away
Speaker 1: to the manufacturing plants where these drugs are made, and
Speaker 1: basically opened my eyes to a world where companies wanted
Speaker 1: to make the cheapest drugs possible and sell them at
Speaker 1: the highest possible price. I was thinking about this parallel
Speaker 1: to the Farness story, because one of the Farness whistleblowers
Speaker 1: talks about the carpeted world of executives where everything looks beautiful,
Speaker 1: and the tiled world, this frantic, ugly world where all
Speaker 1: the shenanigans are going on. And I was thinking, that's
Speaker 1: a great analogy for your book as well, because you
Speaker 1: have the carpeted world of the generic drug industry and
Speaker 1: all the good it's doing and the gleaming surfaces of it,
Speaker 1: and then this crazy mess underneath it, crazy mess, absolutely
Speaker 1: a crazy miss. I delved into the company of Rambaxy
Speaker 1: and it was a staggering picture. There was a whistleblower
Speaker 1: named Denish Tucker, and he had been a young information
Speaker 1: architect at Bristol Myers squib and his specialty was managing
Speaker 1: large data sets, and he was hired by Rambaxy to
Speaker 1: come and track their burgeoning pipeline all across the world.
Speaker 1: So he moved his whole family to Gergawan in two
Speaker 1: thousand and three and he hired a team at Rambaxi.
Speaker 1: And you know, it was a strange corporate environment. There
Speaker 1: were fist fights in the executive boardroom. There were drug
Speaker 1: ingredients next to the half and half in the employee fridge.
Speaker 1: There were chain smoking medical directors. I mean, there's just
Speaker 1: a total contrast to the buttoned up Brestol Myers squib world.
Speaker 1: He had come from complete contrast. But he took that
Speaker 1: as a sign that his services were needed at Rambaxi.
Speaker 1: And then the first boss who brought him in left
Speaker 1: abruptly under somewhat range circumstances, and about four weeks after
Speaker 1: his next boss came in recruited from England from Glaxo
Speaker 1: Smith Klein, a lovely fellow named doctor Raj Kumar, excellent,
Speaker 1: impeccable reputation. Kumar asks him to come by his office
Speaker 1: very early one morning and says to him, we're in
Speaker 1: big trouble. And there had been a contract research organization
Speaker 1: that had tested Rambasi's drugs, and regulators had gone into
Speaker 1: that testing company had found fraud and they were as
Speaker 1: a result concerned about the quality of Rambasi's drugs, and
Speaker 1: this opens the proverbial can of farms. Kumar gives him
Speaker 1: an assignment. He says, I want you to look into
Speaker 1: Rambasi's regulatory filings around the world, which is basically all
Speaker 1: of the data that we've given regulators to show them
Speaker 1: that our drugs are clinically therapeutically equivalent and make sure
Speaker 1: that the data is legitimate. So Tucker works around the
Speaker 1: clock with his team and basically uncovers Ranbaxy's dark secret,
Speaker 1: which is that they have fabricated the data of over
Speaker 1: two hundred drug products and more than forty countries around
Speaker 1: the world. Talk a little bit about the culture of
Speaker 1: Ranbaxies such that people didn't speak up that this was
Speaker 1: the way things were done. This was a company that
Speaker 1: was focused on profit before all else. Their goal was
Speaker 1: to get to a billion dollars in US sales within
Speaker 1: a short period of time, and they named it their
Speaker 1: Garuda vision, which is after a soaring Indian eagle, and
Speaker 1: they had posters up on the walls of the office
Speaker 1: reminding employees of that goal. So there were incentives in
Speaker 1: the generic drug world that basically prompted companies to be
Speaker 1: as quick to market as possible in order to realize
Speaker 1: more profit. That's because then they get lassivity on their drugs,
Speaker 1: so they can price the generic drug less than the
Speaker 1: brand name, but higher than they'll be able to once
Speaker 1: the frantic generic competition begins. Right, So they've got this
Speaker 1: brief shining window to make money if they can get
Speaker 1: there first. Right. So the incentive is called first to file,
Speaker 1: And basically, if they're first through the door with their
Speaker 1: FDI application and that gets approved, as you said, they
Speaker 1: get six months exclusivity before generic competitors come in. The
Speaker 1: rush to be first was so intense that it had
Speaker 1: led generic drug executives to camp out in the FDA
Speaker 1: parking lot. They slept in limos and stretch limos. They
Speaker 1: pitched tents, they rotated throughout the night. Fistfights broke out
Speaker 1: in the parking lot, all to be first through the door.
Speaker 1: I want to go back to this character of tech
Speaker 1: Or for a little bit. Help me understand his character,
Speaker 1: because he becomes a whistle blower, and what is it
Speaker 1: about him that makes him into a whistle blower. He
Speaker 1: couldn't let things go, He couldn't just say it was
Speaker 1: somebody else's problem. He lay awake after he was forced
Speaker 1: out of the company. He lay awake night after night,
Speaker 1: and he had these data sets in his head. He
Speaker 1: knew the quality of the drugs. He knew they were poor,
Speaker 1: and he knew that the patients in Africa were getting
Speaker 1: the worst of the company's drugs. The drugs were no good.
Speaker 1: They would degrade in hot temperatures. Pause on this dual system,
Speaker 1: because as bad as the manufacturing is, you note in
Speaker 1: your book that there's also this system in place where
Speaker 1: markets like the US, for whatever the problems in the US,
Speaker 1: we're actually getting the better quality drugs. And there really
Speaker 1: is this better products for the rich, worst products for
Speaker 1: the poor dynamic taking place too, which is really heartbreaking.
Speaker 1: This is a secret, essentially a secret within the generic
Speaker 1: drug industry, which is called dual track productions. Essentially, as
Speaker 1: you say, they make drugs of different quality for different
Speaker 1: markets depending on the vigilance of the regulators. So in
Speaker 1: the least regulated markets they will send their worst drugs
Speaker 1: and essentially they never have to discard failing drugs because
Speaker 1: there's always a market to send them too. It's incredibly depressing.
Speaker 1: So come back to this story of Ranbaxy, and generic Laboratour,
Speaker 1: because you have these two events hurtling toward each other,
Speaker 1: and it seems inconceivable that the two come to pass
Speaker 1: at the same time, and yet they do. You have
Speaker 1: the companies of Russian to be the first to make
Speaker 1: generic laborator, and then you've got this criminal investigation of
Speaker 1: its shoddy manufacturing practices, and you would think that the
Speaker 1: second would preclude the first, right. So in two thousand
Speaker 1: and five, Tucker are no longer able to stand the
Speaker 1: thoughts he's having about these drugs, reaches out to regulators
Speaker 1: around the world under a pseudonym, and really the only
Speaker 1: regulator who contacts him back is the FDA, the only
Speaker 1: one who gets back to him. Nobody cares, nobody seems
Speaker 1: to care. But he finally wrote directly to the commissioner
Speaker 1: of the FDA and pleaded with him to put a
Speaker 1: stop to what he called a crime. That got him
Speaker 1: in dialogue with FDA regulators. They begin to investigate his claims,
Speaker 1: and of course he has documentation, so they believe him
Speaker 1: and they begin a criminal investigation of Rambasi. At the
Speaker 1: same time that they're doing that, they're approving rambacksies drugs
Speaker 1: and looming on the horizon is the launch of generic Lipertore.
Speaker 1: How can these things be happening at the same time.
Speaker 1: How can they be approving Rambacksis drugs and not pulling
Speaker 1: all of rambacks these drugs from the market, and yet
Speaker 1: begetting this incredibly devastating information from a whistle blower who's
Speaker 1: telling them that everything is essentially a fraud. It is
Speaker 1: just the greatest question, And after ten years of investigating this,
Speaker 1: I'm not sure that I have a good answer for it,
Speaker 1: except that they somehow convinced themselves that the approvals had
Speaker 1: to go forward, that they were trying to do due diligence.
Speaker 1: If there wasn't a specific smoking gun in the application
Speaker 1: of a specific drug, that maybe it was okay to take.
Speaker 1: It was a kind of labyrinthine groomy I think exercise
Speaker 1: which nobody can really understand because it's not understandable. How
Speaker 1: much does the pressure for lower drug prices because of
Speaker 1: RISS in America with high pharmaceutical prices, how much does
Speaker 1: the pressure to have generic drugs available contribute to something
Speaker 1: like that happening? I think probably a lot. I think
Speaker 1: they're under tremendous pressure from Congress to approve more generics
Speaker 1: more quickly. There's also drug shortages, so there's not enough
Speaker 1: low cost drugs. And between those two things and the
Speaker 1: sense that somehow rambasy being this enormous company, was just
Speaker 1: too big to fail, and so they just the approvals
Speaker 1: kept coming, and it really came to a head with
Speaker 1: the approval of generic Flipotour, which is the regulators were
Speaker 1: sort of staring down the barrel of this giant decision
Speaker 1: because of a strange little legal provision. If they did
Speaker 1: not approve Rambaxi's drug, then they were afraid that Rambaxi
Speaker 1: could park its exclusivity and no other manufacture wouldn't be
Speaker 1: to them or at all. So they felt they had
Speaker 1: to approve Rambasi's drug, but they had to go through
Speaker 1: the steps of approval. So they rushed a preapproval inspection
Speaker 1: at one of Rambasi's plants in India and they just
Speaker 1: found a disaster. There was a shredder on the factory
Speaker 1: floor where they were destroying. And then shredders are never
Speaker 1: good in business stories rights, aren't business gone wrong? Once
Speaker 1: you see the shredder, absolutely, it's like the gun on
Speaker 1: the mantelpiece, you know, the shredder on the factory four
Speaker 1: floor is what you would call a clue. So the
Speaker 1: inspector who goes in determines that this plant is what
Speaker 1: is called official action indicated, it's bad and it needs
Speaker 1: to make corrections immediately. And what the officials do in
Speaker 1: Maryland is they downgrade that finding, they alter the finding,
Speaker 1: they make it okay enough to approve. So for six months, Rambaxy,
Speaker 1: this company saturated in fraud, is the only generic manufacturer
Speaker 1: of lippatore. They make a hundred million dollars in twenty
Speaker 1: four hours, that's how big this launch was. And about
Speaker 1: nine months after the launch begins they have to recall
Speaker 1: millions of the drugs because they have glass fragments in them.
Speaker 1: Glass fragments and one's lipatour does not sound like an
Speaker 1: appealing prospect. It is not appealing. No, it's absolutely not appealing,
Speaker 1: and any better word. They knew that the plant that
Speaker 1: was manufacturing this was not okay. We think about just
Speaker 1: our systems of checks and balances and regulation and how
Speaker 1: important this is. How much is this a tale of
Speaker 1: just an outgunned and overwhelmed regulator as well? It's certainly
Speaker 1: a tale of that here's this domestic agency which kind
Speaker 1: of overnight in this wave of globalization, has to become
Speaker 1: this policeman around the world. They're totally ill equipped to
Speaker 1: do so, totally ill equipped to do so, and they
Speaker 1: love to talk about their global regulatory partners, but the
Speaker 1: Indian regulators basically see themselves as an arm of industry.
Speaker 1: They're completely hostile to the FDA's findings and they're facing
Speaker 1: a mentality where the Indian plant owners are just figuring
Speaker 1: out how to trick them. So back to rambacks. They
Speaker 1: end up settling with the US government right for five
Speaker 1: hundred million dollars, and yet no individuals have to plead guilty.
Speaker 1: That was a huge issue because that was very much
Speaker 1: on the table that they were going to charge the CEO,
Speaker 1: Malvinder Singh. There were other people in their crosshairs, but
Speaker 1: only the company pled guilty. I find that such an
Speaker 1: appalling outcome in so many of these cases, that a
Speaker 1: company is made up of individuals, and somehow a company
Speaker 1: can be guilty without an individual having done anything wrong.
Speaker 1: It's astonishing and astonishing in this case, and astonishing that
Speaker 1: it happened so often. How inevitable was the exposure of Rambaxy.
Speaker 1: You write about this document that your whistleblower taker had
Speaker 1: put together. If it weren't for this document, would anything
Speaker 1: have happened? I mean, could it be that this mammoth
Speaker 1: secret could have actually stayed, this dark secret that is
Speaker 1: impaliling lives around the world. Oh, I think it would have.
Speaker 1: I mean I think without Denesh tuck Her coming forward
Speaker 1: and without his documents, I have little doubt that Rambaxi
Speaker 1: would have continued to get away with it. You begin
Speaker 1: the book with a big picture, you narrowed down to
Speaker 1: the story, this incredibly compelling story of Rambaxi, and then
Speaker 1: you broaden again. Rambaxy is emblematic of a larger problem. Right.
Speaker 1: What I was able to uncover is what the FDA
Speaker 1: had actually found in India, because after the Rambaxy story,
Speaker 1: it became clear to the FDA that they had what's
Speaker 1: called a data integrity problem in India. Again, that is
Speaker 1: such a dry phrase for what it actually is. To
Speaker 1: pause on that and talk about what a data integrity
Speaker 1: problem actually is. Well. As one person recently commented online,
Speaker 1: another word for a data integrity problem is an integrity problem. Basically,
Speaker 1: data integrity issues means that at these manufacturing plants, they
Speaker 1: are manipulating or fabricating quality data to make drugs that
Speaker 1: would not pass FDA standards pass. They're making poor quality
Speaker 1: drugs look like high quality drugs through manipulation of the
Speaker 1: testing data, and as the FDA equipped to fix that.
Speaker 1: Even today, the FDA has been a contributor to this
Speaker 1: problem because it announces its inspections weeks and sometimes months
Speaker 1: in advance. I mean even with Rambaxy, that company had
Speaker 1: been under criminal investigation for five years and the FDA
Speaker 1: was still giving it two months of advanced notice that
Speaker 1: it was coming to inspect its plants. So what happens
Speaker 1: paint a picture of what happens the plant. Once the
Speaker 1: FDA has announced its coming, the plants send in data
Speaker 1: fabrication teams. Sometimes it's as many as twenty people, and
Speaker 1: they will go through They will shred incriminating documents. They
Speaker 1: will fabricate documents to the extent they're fabricating their own
Speaker 1: standard operating procedures, like they have no rules, they invent rules.
Speaker 1: And then in some cases they will steam these documents
Speaker 1: overnight in steam rooms to make them look old. I
Speaker 1: had no idea one could steam a document that actually
Speaker 1: never occurred to me. You know, it's sort of like,
Speaker 1: I don't know if your kids have had these colonial
Speaker 1: arts and crafts projects where they have to make documents
Speaker 1: look old and they pour coffee on them. Well, in
Speaker 1: this case, it's apparently more effective to steam them in
Speaker 1: a room, and then they try to clean and make
Speaker 1: the plant look as pristine as possible, right, even though
Speaker 1: a scaled inspector can see the signs that the pristine
Speaker 1: is just the surface. Yeah, as one of my sources said,
Speaker 1: they can make anything look like anything. So you give
Speaker 1: them a weekend. They've got low cost labor. They can
Speaker 1: put up a building. But in a number of cases
Speaker 1: they would, for example, clean up bird infestations. They will
Speaker 1: falsify their own sterility data which show that the plants
Speaker 1: are sterile, because you have to test air, you have
Speaker 1: to test water, you have to test surfaces to make
Speaker 1: sure that they're free of microbial contamination. And just to
Speaker 1: be clear, these plants are so strictly regulated that in
Speaker 1: sterile plants where you have to have unidirectional airflow, employees
Speaker 1: cannot move quickly because that will alter the airflow. So
Speaker 1: we're talking about these fundamental manipulations to literally depict these
Speaker 1: plants as sterile when they're not. So now that you've
Speaker 1: written this, or now that the FDA discovered all these problems,
Speaker 1: they don't announce their inspections anymore. Right. The FDA ran
Speaker 1: a pilot program in India from twenty fourteen through mid
Speaker 1: twenty fifteen where they did all of their inspections either
Speaker 1: unannounced or on short notice, and the rate of serious
Speaker 1: findings that these plants increased by almost sixty percent. And
Speaker 1: you would think, Okay, they're going to then make this
Speaker 1: no notice inspection this standard everywhere in the world. Instead,
Speaker 1: the FDA canceled this program and went back to pre
Speaker 1: announced and spies. I think it's because they have no
Speaker 1: plan B for our drug supply. We are desperate for
Speaker 1: these drugs. We have drugs already in shortage, and in
Speaker 1: every plant where they find these calamitous situations, they have
Speaker 1: to restrict those drugs from being imported to the US.
Speaker 1: So it comes back to the story of lipotour In
Speaker 1: the end, the same reason that the FDA approves generic
Speaker 1: lipotour made by Rambaxy, as this criminal investigation as nearing
Speaker 1: its apex, which is the need for this drug to
Speaker 1: reduce pharmaceutical prices. This really just is the microcosm of
Speaker 1: this larger issue, which is this overwhelming pressure for cheaper drugs. Yeah,
Speaker 1: and there's another issue here, which is that the FDA's
Speaker 1: budget comes from the number of drugs that they approve.
Speaker 1: So because the generic drug manufacturers pay for the approval process,
Speaker 1: that's right, they pay user fees. So how do you
Speaker 1: get a guy like Peter Baker, who's this FDA investigator
Speaker 1: who really tries to do his job, and what happens
Speaker 1: to him in the end. As Peter Baker inspected in India,
Speaker 1: his notoriety to the point that he was followed. He
Speaker 1: was poisoned with tainted water at these manufacturing plants. On
Speaker 1: one inspection he was on, they bugged one of the
Speaker 1: inspector's hotel rooms. He would present manufacturing executives with black
Speaker 1: and white evidence of data fabrication. They would completely deny it.
Speaker 1: For example, there was a bathroom where the toilets had
Speaker 1: no drainage piping. And this was a bathroom that was
Speaker 1: right in a manufacturing plant. Yes, and the bathroom was
Speaker 1: right off of the sterile manufacturing area. So he pointed
Speaker 1: out the urine is falling on the floor, and the
Speaker 1: plant executive said to him, well, the stickers above the
Speaker 1: toilets show that it's under repair, but there were no stickers,
Speaker 1: which he pointed out, but there are stickers. So it
Speaker 1: was this through the looking glass experience. And after about
Speaker 1: eighteen months in India dealing with this, and he was threatened,
Speaker 1: he was physically threatened. He was diagnosed with post traumatic stress.
Speaker 1: Does your reporting experience ultimately show a cautionary tale for
Speaker 1: people like Peter Baker and your whistleblower taker who try
Speaker 1: to do the right thing? Does it work out for them?
Speaker 1: Or is this ultimately a cautionary tale for those to
Speaker 1: try to do good. I think it's a cautionary tale,
Speaker 1: but I'm not sure that they would do anything differently.
Speaker 1: As Peter Baker said, American patients deserve good drugs, and
Speaker 1: he literally felt like he was the last person standing
Speaker 1: between potentially lethal drugs and the American patient because the
Speaker 1: drugs were going to leave those plants and go directly
Speaker 1: to American farm of these people are just hardwired to
Speaker 1: do the right thing in the face of incredible pressure
Speaker 1: to do otherwise. I think so. So you also chronicle
Speaker 1: in the book back when the generic drug industry first
Speaker 1: got started. Here there's this mammoth scandal where all these
Speaker 1: bad things are happening. And then we've got this scandal
Speaker 1: rambacksa and this evidence that so many manufacturers aren't following
Speaker 1: the practices they need to fulmy one, shame on you,
Speaker 1: fulmy twice, shame on me? Are we at fulmi three times?
Speaker 1: There was, as you say, this generic drug scandal of
Speaker 1: the nineteen eighties in which US based companies were fabricating
Speaker 1: data and they were bribing FDA reviewers to approve their
Speaker 1: drug applications. That got busted up. It's a huge scandal.
Speaker 1: But now we have sort of a similar thing unfolding.
Speaker 1: It's just seven thousand miles away, and the FDA is
Speaker 1: saying the same set of things it did. Everybody can
Speaker 1: trust their drugs, take them with confidence. Everything is fine.
Speaker 1: We have not fixed this problem. Do people care enough?
Speaker 1: Why don't people care more about this issue? I think
Speaker 1: what's difficult for the consumer in this picture is that
Speaker 1: there's very limited options. Insurance has basically lost us into
Speaker 1: getting certain drugs. You know, we go to the pharmacy,
Speaker 1: we get the drugs were given. We don't think about
Speaker 1: who the manufacturer is. We take them. If we have
Speaker 1: side effects, we don't attribute it to the drugs. You
Speaker 1: need to know a lot in order to be able
Speaker 1: to assess your options. To say, wait a second, this
Speaker 1: manufacturer was accused of data fabrication and got warning letters
Speaker 1: from the FDA, and so I'd rather not take their drugs.
Speaker 1: Let me take this other manufacturer. And you need to
Speaker 1: know that the warning letter isn't just that an I
Speaker 1: wasn't dotted and a T wasn't crossed, right, It's not
Speaker 1: just a bureaucratic misstep. It actually is a serious thing.
Speaker 1: What's the way out of this conundrum? Because he wrote
Speaker 1: a sentence that really stood out to me. With public
Speaker 1: fury fix on ever rising drug prices, the message that
Speaker 1: the nation's most affordable drugs were compromised was unwelcome, and
Speaker 1: that's again the core of this what's the way out?
Speaker 1: There's not one fix, it's a series of fixes. First
Speaker 1: of all, to state the obvious, the FDA has to
Speaker 1: do unannounced inspections at every plant they go to around
Speaker 1: the world. We can't make nice with governments and basically
Speaker 1: discard the public health of all of the Americans as
Speaker 1: a result, I mean, we have to step up and
Speaker 1: be strict in these markets where we're regulating. So that's
Speaker 1: number one. Number two, we have to regulate brand name
Speaker 1: drug prices. If those were somewhat more affordable, we wouldn't
Speaker 1: necessarily be forced into the arms of these low cost
Speaker 1: manufacturers overseas. We've given ourselves no other option. And yet
Speaker 1: that second option, despite President Trump's noise about reducing drug prices,
Speaker 1: has been something that has thwarted every administration for forever,
Speaker 1: right right, I mean, it's just who's going to stand
Speaker 1: up to the pharmaceutical lobby. I mean, that's real question.
Speaker 1: The other thing we need to do is start making
Speaker 1: our own drugs again. Now, there's a couple of interesting
Speaker 1: things that are happening out there that might be sort
Speaker 1: of models for a way forward. So there are a
Speaker 1: couple of nonprofit drug bakers that have coalesced around these
Speaker 1: this issue of shortages and have decided to try to
Speaker 1: do US manufacturing in a nonprofit model. It's actually fascinating
Speaker 1: because your book is this larger story too, of the
Speaker 1: end of manufacturing in the US, right, and what the
Speaker 1: real cost of globalization that are losing our manufacturing prowess
Speaker 1: has been absolutely and it's really encouraging to hear that
Speaker 1: there's a recognition that that needs to change. I think
Speaker 1: there is a wide recognition, and part of that is
Speaker 1: because of these drug shortages. If the market is not
Speaker 1: going to reward it's not going to reward quality, it's
Speaker 1: not going to reward the making of these low cost drugs.
Speaker 1: We can't afford to do it in the US. Maybe
Speaker 1: there has to be a different model here. Isn't another
Speaker 1: part of the conundrum here? You write that it's not
Speaker 1: that companies in Indian China can't manufact they know perfectly
Speaker 1: well how to do it. It's just this cost pressure
Speaker 1: that good manufacturing, really having a good process cost more
Speaker 1: money twenty five percent more. You write, and so how
Speaker 1: does that ever get any better in a business world
Speaker 1: that is increasingly driven by bottom line profit? I'm not
Speaker 1: sure that it gets better, except to say that regulators
Speaker 1: have to be more stringent and observe more pressure, and
Speaker 1: so the downside of getting caught has to be severe
Speaker 1: enough that it promotes compliance, unlike in the case of Rambacksay,
Speaker 1: does it have to be individuals? Oh? Absolutely, I mean
Speaker 1: you should start sending pharma executives to jail. I think
Speaker 1: things might improve rather swiftly. I think that might do it.
Speaker 1: On that note, thank you so much for coming. It's
Speaker 1: been lovely and fright to talk to you. Thank you
Speaker 1: so much, what a pleasure to chat with you. So
Speaker 1: like many people, I take a generic drug level thyroxin.
Speaker 1: Over the years, I've read plenty of complaints from people
Speaker 1: online talking about how the generic version of this medicine
Speaker 1: can give them unpredictable symptoms and lead to some variability
Speaker 1: in their results. I've always brushed these complaints off until now.
Speaker 1: I had Catherine take a look at my bottle, and
Speaker 1: she looked at the manufacturing label and said, stop, this
Speaker 1: is one of the shoddiest manufacturers of this drug. You
Speaker 1: need to find a different version. So this is an
Speaker 1: issue that affects all of us. And what's really devastating
Speaker 1: is that there is no easy solution. Think about the
Speaker 1: pressures an overworked, outgunned regulator, a push for profits that
Speaker 1: almost inevitably is going to lead to manufacturing shortcuts, globalization
Speaker 1: and the loss of American manufacturing skills, and ever higher
Speaker 1: prices for brand name drugs as those manufacturers too seek
Speaker 1: to extract every dollar they can. They are by leading
Speaker 1: to more and more demand for drugs. Despite the obvious
Speaker 1: problems with the industry. This is not business at its best.
Speaker 1: Making a Killing is a co production of Pushkin Industries
Speaker 1: and Chalk and Blade. It's produced by Ruth Barnes and
Speaker 1: Rosie Stouffer. My executive producers are Alison mcclein. No relation
Speaker 1: in Making Casey. The executive producer at Pushkin is Mia Lobo.
Speaker 1: Engineering is by Jason Gambrel. Our music is by Jed Flood.
Speaker 1: Special thanks to Jacob Weisberg at Pushkin and everyone on
Speaker 1: the show. I'm Bethany McLean. Thanks so much for listening.
Speaker 1: Find me on Twitter at Bethany mac twelve and let
Speaker 1: me know who you've enjoyed hearing from.