As the cost of prescription medication soars, consumers are increasingly taking generic drugs: low-cost alternatives to brand-name medicines. Often health insurance plans require patients to switch to generics as a way of controlling costs. But journalist Katherine Eban warns that some of these medications might not be as safe, or effective, as we think.
Eban has covered the pharmaceutical industry for more than 10 years. She notes that most of the generic medicines being sold in the U.S. are manufactured overseas, mostly in India and China. The U.S. Food and Drug Administration states that it holds foreign plants to the same standards as U.S. drugmakers, but Eban's new book, Bottle of Lies, challenges that notion. She writes that the FDA often announces its overseas inspections weeks in advance, which allows plants where generic drugs are made the chance to fabricate data and results.
"These plants know that [the FDA inspectors are] coming," Eban says. "I discovered [some overseas drug companies] would actually ... alter documents, shred them, invent them, in some cases even steaming them overnight to make them look old."
(In a statement to NPR, the FDA said that Americans "can be confident in the quality of the products the FDA approves" and notes it has "conducted a number of unannounced inspections" at foreign plants over the past several years.)
As a result, Eban says, generic drugs sometimes go to market in the U.S. without proper vetting. She describes the FDA as "overwhelmed and underresourced" in its efforts to ensure the safety of overseas drug production.
Eban advises consumers to research who manufactures their generics and look up any problems that regulators have found out about them. But some consumers may find they are not allowed by their health plan to switch to alternatives, because of cost.
On why many drug companies moved production overseas
There were a couple of reasons for this surge in globalization in the drug industry. One was environmental regulations. ... How are you going to safely dispose of all the chemicals and solvents that you're using? And ... there was less environmental regulation overseas. But another one is: If you move your manufacturing plant to India, you're going to save a huge amount on labor costs and supplies — ingredients — overnight.
And so what you saw was a huge migration, both of manufacturing to Indian-owned companies, Chinese-owned companies, but also Western- and U.S.-based companies, buying up manufacturing plants overseas and moving their manufacturing there.
On how the 1984 Hatch-Waxman Act changed the generic-drug industry
What it created was a pathway at the FDA, a distinct application process for generics, because prior to Hatch-Waxman, basically the generic companies had to do the same set of tests [and] clinical studies that the brand did, and Hatch-Waxman said, you know what? We're gonna give you an abbreviated application. You can do the clinical studies on many fewer patients, because we've already proven safety and efficacy of this molecule in the human body.
But what Hatch-Waxman did that really ignited the generic-drug revolution is it gave the companies an incentive: The incentive was called "first to file," and it said if you are the first company to submit your application — and literally first by the minute or the second — and you get approved, you're going to get six months of exclusivity on the market to be the lead and only generic, and you're probably going to be able to sell your drugs at about 80 percent of the brand-name price. And that "first to file" really became the difference between making a fortune and making a living.
On how some plants that make generics prevent FDA inspectors from doing thorough inspections
In several instances I documented, the investigators were poisoned in the course of their inspections with tainted water from the tap, which you can't drink in India. They felt sick during inspections. I mean, this was a way of running out the clock. They were followed. In one instance, an investigator had his hotel room bugged. In some cases that I had heard about, [the plants] were trying to scan passenger lists in airports to try to determine exactly who was coming when. So there were elaborate measures that the plants took to try to protect against bad inspections.
On how the quality of generic drugs can vary depending on where the drugs are being sold
Generic-drug makers are adjusting the level of quality in their manufacturing depending on which market their drugs are going to, and depending upon the vigilance of the regulators in those markets. So they will take their biggest shortcuts, their biggest swaps of high-quality to low-quality ingredients, in markets with very poor regulation: sub-Saharan Africa, Southeast Asia, areas of South America.
On the Trump administration's efforts to ease corporate regulations
Once you understand how vital these regulators are to safety and well-being, basically any sane American is not going to want to take a pill that's coming from a plant that's uninspected. These regulators are doing absolutely vital work, and you can't go into this and come out thinking you want less regulation. I mean, it is too perilous and the costs of having, you know, nonsterile plants, non-bio-equivalent drugs — that cost is just too high.
But definitely, I think under the Trump administration you do see a more lenient attitude towards corporations generally, which, you know, has sort of trickled down to the FDA. But on the other hand, looking at the whole picture, I would have to call this a bipartisan failure that has not thought through in a systemic way how to respond to a drug supply in a globalized world.
On how much consumers should worry about the safety of generic drugs
One drug investigator said to me that he thinks the concern is higher for people on maintenance medications who are taking these drugs day in and day out. Those drugs may have toxic impurities. Those can build up in your liver, you may not know it, or you may be having side effects that you didn't think about before, and then you realize, "Wait a second I was switched to a different generic" or "I was switched from a brand to a generic."
So I think that once consumers start thinking about this as a factor ... I think they wake up to the fact that there may be consequences for them. ... You can look on the dispensing label, you'll have the name. Go into Google, put in the name of that company and "FDA warning letter." What has the FDA found out about this company? Has this company had drug recalls? It is a bit of sleuthing, but if you're taking this medication day in and day out, it's worth it.
Sam Briger and Mooj Zadie produced and edited the audio of this interview. Bridget Bentz, Molly Seavy-Nesper and Carmel Wroth adapted it for the Web.
TERRY GROSS, HOST:
This is FRESH AIR. I'm Terry Gross. If you regularly take a medication, chances are pretty good it's a generic drug made overseas. Our guest, journalist Katherine Eban, has covered the pharmaceutical industry for more than 10 years, and her new book is a chilling look at problems with generic drugs manufactured in India and China. The U.S. Food and Drug Administration theoretically holds foreign plants to the same standards as U.S. drugmakers, but Eban reports on troubling cases of forged records, unsterile conditions and sloppy manufacturing processes that have generated hundreds of thousands of complaints to the FDA, including one from a 71-year-old retiree who found a centipede-like bug in the capsule of her blood pressure medication, alive and wiggling.
Katherine Eban is an investigative journalist and a contributor to Fortune magazine. She is the author of a previous book about the pharmaceutical industry called "Dangerous Doses." FRESH AIR's Dave Davies spoke with her about her new book "Bottle Of Lies: The Inside Story Of The Generic Drug Boom."
DAVE DAVIES, BYLINE: Well, Katherine Eban, welcome to FRESH AIR. Your books begins with a pretty gripping store of an inspector for the Food and Drug Administration - guy named Peter Baker. He is heading to inspect a factory in India. First of all, why is the FDA going into a factory in India?
KATHERINE EBAN: Starting in about 2005, the U.S. FDA had more plants to inspect overseas than it did in the U.S. because our - basically, our drug supply has - the production of it has shifted over there. And there are hundreds and hundreds of drug plants in India that make our low-cost generic drugs that we all depend on. So really, globalization had transformed Peter Baker's job. And he was headed to a plant run by a company called Wockhardt that was in Waluj, Aurangabad, in India to inspect a sterile drug plant...
EBAN: ...Which has to operate under very strict regulations.
DAVIES: So what happens when he arrives?
EBAN: So he only has five days to inspect a plant that's about the size of a small city. And they've known in advance that he's coming, so they have prepared for his inspection, which is critical to the plant's continued operations. And it's - he has five days there. It's the second day of his inspection, and he gets to an area of the plant which is just a long hallway with bright fluorescent lights.
And as an investigator, he is sort of keenly aware of body language, eye contact and a lot of pieces of information when he goes into a plant. He sees an employee at the other end of this long hallway who doesn't see him yet. And the man has a sort of furtive look to him, and he's holding a clear garbage bag. And it seems clear that he's trying to get it out of the plant. And the man walks and then freezes when he sees Peter Baker at the other end of this hallway and turns around and starts walking back the way he came. And Peter Baker's companion, who's a colleague who's a microbiologist, yells out, stop. And the man breaks into a run and tosses the bag into a waste area beneath a stairwell and then careens out of sight.
And Baker runs and retrieves the bag, and it's got these torn manufacturing records inside of it. And those lead him, step by step, into this harrowing set of discoveries, which is that the documents reveal that the plant released, to Indian and other foreign markets, vials of insulin that had metallic fragments in it - which is potentially deadly - and came from a defective piece of equipment in an undisclosed part of the plant. And once he gets there, he finds out worse news, which is that the company is making a drug for the U.S. - it's called adenosine. It's a sterile injectable cardiac drug - using the same defective equipment. And all of the records related to this manufacturing are secret. They haven't been entered into the company's official set of records that they're required to show to the FDA. So that's what he uncovers from the garbage bag.
DAVIES: Right. And we will talk more about what these findings actually generate in terms of action. But let's talk a little bit about generic drugs. One of the things that I learned from this book is that it can be technically challenging for a company to reproduce a generic version of a brand-name drug. Why?
EBAN: Well, first of all, the brand-name companies sort of build a citadel of patents around the generic drug. And so it's not like they hand over a formula or cookbook to the generic companies. They're fighting every step of the way to protect their patents. And what the reverse engineers who work for the generic drug companies need to do is try to break down the drug in a laboratory and reconstruct it under a different pathway so that they can essentially get around the patent.
And then there are other elements of the drug that are protected by separate patents, like the time release mechanisms. And all of that has to be recreated, additionally using possibly a new set of excipients, which is the additional ingredients. And then you've got to get the dissolution right.
So there's all kinds of aspects to this. And then you have to make sure that it is, quote, unquote, "bioequivalent," which means that it reaches peak concentration in the blood within a range that's close enough to the brand that the FDA will find it acceptable.
DAVIES: Right. So you can take the same active ingredient that the brand name has, but actually putting it in a pill or a capsule or an injectable in a way that it behaves the same way, is absorbed at the same rate is tricky, right?
EBAN: It can be quite tricky. Yes.
DAVIES: So the generic drug boom really, I guess, started in the mid-'80s when Congress changed the law so that these could be more readily available. And there was a bill - the Hatch-Waxman Act. What did it provide that opened the door to more generic drug manufacturing?
EBAN: Well, what it created was a pathway at the FDA, a distinct application process for generics, because prior to Hatch-Waxman, basically, the generic companies had to do the same set of tests, clinical studies that the brand did. And Hatch-Waxman said, you know what? We're going to give you an abbreviated application. You can do the clinical studies on many fewer patients because we've already proven safety and efficacy of this molecule in the human body.
But what Hatch-Waxman did that really ignited the generic drug revolution is it gave the companies an incentive, and the incentive was called first to file. And it said, if you are the first company to submit your application - and literally first by the minute or the second - you're going to get - and you get approved - you're going to get six months of exclusivity on the market for the - to be the lead and only generic.
And you're probably going to be able to sell your drugs at about 80% of the brand-name price. And that first to file really became the difference between making a fortune and making a living. So that incentivized the generic drug industry to be first.
DAVIES: Right. It offered a way to make a lot of money in a hurry - at least for six months. But it also meant that you didn't have as rigorous testing. I mean, you had to show that your drugs were bioequivalent to the brand names, and you had to have all this data. When and why did so many of the manufacturing migrate overseas?
EBAN: There are a couple of reasons for this surge in globalization in the in the drug industry. One was environmental regulations, which is - how are you going to safely dispose of all the chemicals and solvents that you're using? And that was easier because there was less environmental regulation overseas.
But another one is, if you move your manufacturing plant to India, you're going to save a huge amount on labor costs and supplies, ingredients, overnight. And so what you saw was a huge migration both of manufacturing to Indian-owned companies, Chinese-owned companies but also Western and U.S.-based companies buying up manufacturing plants overseas and moving their manufacturing there.
DAVIES: So how much of our generic drugs and their active ingredients are made overseas?
EBAN: An astonishing amount. Eighty percent of the active ingredient in all our drugs, whether brand or generic, come from overseas, the majority in India and China. Forty percent of the generic drugs - finished doses that we use in this country - come from India alone. Ninety percent of our drug supply is generic. So the numbers are huge. And taken as a total, the generic drug industry is about a $93 billion industry in this country.
DAVIES: Right. And the Food and Drug Administration, which is supposed to ensure, you know, quality and safety, has a challenge here. Does it take responsibility for ensuring that in these overseas production?
EBAN: Well, that is their responsibility. And what they will say is that they've increased inspections overseas, they've reached a kind of parity, which is that they have as many inspections overseas as they do in the U.S. What they don't distinguish or talk about is the quality of those inspections. And that was something I really began reporting on, which is that in the U.S., FDA investigators show up, by and large, unannounced at plants and stay as long as they need.
DAVIES: And can go anywhere they want in the plant.
EBAN: And can go anywhere they want.
DAVIES: Yeah. Right.
EBAN: Yes. So overseas, because of complex logistics of getting visas and scheduling, the FDA decided to take a different route, which is they announce their inspections in advance and, as I found, sometimes literally give two months' notice. The plant invites the FDA to inspect. They're arranging local travel and accommodations for the investigators, who are essentially invited guests at the plant. So this has allowed the plants overseas to - in the view of a number of people I interviewed - stage these inspections. They do not reflect actual conditions in the plant.
DAVIES: Katherine Eban's new book is "Bottle Of Lies: The Inside Story Of The Generic Drug Boom." We'll talk more after a short break. This is FRESH AIR.
(SOUNDBITE OF AVISHAI COHEN'S "GBEDE TEMIN")
DAVIES: This is FRESH AIR, and we're speaking with Katherine Eban. She's an investigative journalist who spent years covering the pharmaceutical industry. Her new book, which explores problems with the safety and effectiveness of generic drugs, is called "Bottle Of Lies."
You write a lot about an Indian company called Ranbaxy. And there's an early case that you describe involving a generic drug called Sotret. It's a generic version of the acne medication Accutane. There were problems. What happened?
EBAN: So Ranbaxy was having problems getting the drug to dissolve correctly 'cause it has to dissolve correctly in the body. And they had a launch. And they had a generic manufacturer right on their heels to come in and launch. And they knew that the 40-milligram version of this drug was failing. And they had a sales meeting at a Boca Raton hotel in 2003 to figure out what to do.
And what they needed to do was tell the FDA they had a failing drug and recall it from the market. Instead, what they decided to do was continue the launch of the drug and try to figure out, even as they were selling the drug, how to properly make the drug. And what they did - which is absolutely against regulation - is they started altering the ingredients of the drug in the laboratory secretly without telling the FDA.
DAVIES: Did it produce harm?
EBAN: Oh, there were a number of patient complaints and some very serious repercussions of this. And ultimately, the actions of the company around that drug and two others led them to plead guilty in 2013 to seven felonies.
DAVIES: Right. You have a long investigation of Ranbaxy that's described in detail in the book. This is one of many cases. You describe a city in India called Gurgaon. What was noteworthy about this city?
EBAN: Well, Gurgaon is really sort of the global hub of outsourcing. And it's where a lot of American companies and a lot of global companies set up back offices in the early 2000s. And Ranbaxy had its research headquarters in Gurgaon, along with a number of other companies.
DAVIES: Right. And what's the city like? You've been there, I take it.
EBAN: I spent time in Gurgaon. I mean, what's striking about reporting in India on the drug industry is that you have an incredibly regulated industry with very strict requirements for sterility and documentation and yet, these plants are surrounded by what, in the eyes of somebody from the U.S., is complete chaos - you know, animals wandering the road, people living on the sides of the road in tarps, you know, crazy traffic that follows no rhyme, reason, traffic lights, signage.
And you know, a lot of people I interviewed basically said there is a kind of disconnect about drug manufacturing in India, which is you have people navigating an environment like that every day, and then they're supposed to walk into a plant and follow all of these very strict rules. And so it's a kind of really split screen of conduct that is required of them, which can be a sort of cultural challenge as far as manufacturing.
And, you know, drug plants are really places that have cultures. And it's - you have people talk about a culture of quality and how that comes from the top down. And that issue of culture was often at the center of some of the data falsification schemes that I describe in the book.
DAVIES: In 2003, Bill Clinton, who was then out of office for a few years, made a visit to the city. It was a big deal for Ranbaxy and other generic drugmakers in India. What was going on?
EBAN: In many ways, Bill Clinton put the Indian generic industry on the map for U.S. consumers. What he did was incredibly important, which was to help get the generic drug industry in India to drop its prices dramatically enough that the U.S. government could then buy up HIV/AIDS drugs in bulk and send them to Africa under a charitable program that was actually launched by George W. Bush, called PEPFAR. And one debate around the PEPFAR drugs was, we don't want to be using U.S. taxpayer dollars to buy low-quality drugs to send to Africa. We have to ensure that the drugs are high quality.
So they created a sort of tracking and an evaluation program inside FDA to ensure the quality of these drugs, which really set off a lightbulb for people in the U.S. Hey - wait a second - if our regulators say these drugs are high enough quality to send to Africa then we can take them, too. And that is what really launched the generic drug boom, the magnitude that we see today here in the U.S.
DAVIES: Because Indian drugs had a bad reputation before this?
EBAN: They did. And so suddenly, our regulators were approving these drugs for use in Africa. Nobody here could afford their brand-name drugs. We had all these low-cost drugs that the FDA was approving. Why don't we take them, also, was the thought?
DAVIES: So Clinton, through the Clinton Foundation, was involved in this effort to address the AIDS problem in Africa, and a result was this huge effort, and lots of money and an agreement by big pharmaceutical companies to permit cheaper drugs to go.
DAVIES: It was a big deal.
DAVIES: And so there was a lot of business for Indian pharmaceutical companies providing these antiretroviral drugs. Am I saying that right?
DAVIES: Drugs for - to address the HIV. Ranbaxy, this company that you looked into, was one of them. And you write about a young man, Dinesh Thakur, who had come to the company and had been in - had worked in drug manufacturing in the U.S. And he learned something about the testing of these drugs that were going to South Africa. What did he discover?
EBAN: So his boss, Dr. Raj Kumar, was very concerned because an audit had been done of a contract research organization that was testing Ranbaxy's drugs, and it revealed a lot of fraud. And that made Thakur's boss, Kumar, concerned. Well, what is that telling us about Ranbaxy's drugs? Are they OK? Are they bioequivalent? The South African government was asking for answers. So Kumar gave Thakur a really crazy research project in the annals of due diligence, which is, I want you to look into all of Ranbaxy's regulatory filings worldwide and find out what is real, what is fake, where do Ranbaxy's liabilities lie? Is the data supporting these drugs legit?
And Thakur, who is, you know, a hardworking employee, begins this research project with his team and discovers, essentially, Ranbaxy's secret, which is that it is falsifying its quality data for the drugs that it is selling literally around the world. More than 200 products in more than 40 countries were submitted with completely invented quality data or data that was seriously manipulated, falsified. All kinds of shenanigans, like using the actual brand-name drugs in lieu of the company's drugs and using that data to show that their drugs were an exact replica.
GROSS: We're listening to the interview FRESH AIR's Dave Davies recorded with Katherine Eban, author of the new book, "Bottle Of Lies." After a break, we'll talk about more things you can worry about when it comes to generic drugs, and John Powers will review the second and final season of "Fleabag," which he thinks may be the best of the series about smart, provocative young heroines. I'm Terry Gross, and this is FRESH AIR.
GROSS: This is FRESH AIR. I'm Terry Gross. We're listening to the interview FRESH AIR's Dave Davies recorded with investigative journalist Katherine Eban, who's been reporting on the pharmaceutical industry for years. Her new book "Bottle Of Lies" is about generic drugs, which are largely manufactured overseas, often in India and China. While drugmakers there are supposed to adhere to the same standards the Food and Drug Administration sets for American plants, she's found many cases of forged data, unsanitary conditions and ineffective or unsafe products.
Before the break, she was talking about a scandal involving the large Indian drugmaker Ranbaxy. After questions were raised about drugs the company was sending to Africa to treat HIV, a young chemist there named Dinesh Thakur was ordered by his boss to do an investigation of other drugs the company was making. He discovered the company routinely submitted falsified data to regulators and that hundreds of drugs Ranbaxy was selling couldn't be considered safe or effective.
DAVIES: So Thakur and his boss Raj Kumar decide they've got to tell the board about this - the - you know, the governing board of the company - we have a problem, and it's not just with the AIDS drugs in South Africa. It's with all of our drugs. What do they do? What do they tell them?
EBAN: So Thakur prepares a PowerPoint, which came to be known as the self-assessment report, or SAR inside the company. They present it to a subcommittee of the board of directors, and it's a devastating document. In fact, you know, in all my years as an investigative journalist, I think it's fair to say it's one of the most incriminating corporate documents that probably has ever been created. And it basically says more than 200 products in more than 40 countries have data that has been falsified to satisfy business needs. And the company has to pull all these drugs from the market, fess up to regulators around the world.
Kumar presents this to a silent boardroom. And the questions he gets at the end are, can we destroy this document, and, let's destroy the laptop that the document was made on. And in fact, they sent the corporate secretary out of the room and then later falsified minutes of that meeting so that they did not reflect what was presented. So basically, they tried to make this information disappear, and that told Kumar everything he needed to know. And he left the company - just submitted his resignation days later.
DAVIES: And Dinesh Thakur, who had done a lot of the groundwork, a lot of the investigation - what happens to him in the company?
EBAN: So basically, he is sort of slowly - or not-so-slowly forced out of the company. They send company auditors to his division. They peruse his computer records. He alleges they plant porn on his IP address to link it as a reason to kick him out of the company. He submits his resignation.
But after he leaves, he is sleepless. He knows that the drugs this company is making are no good. What bothers him most is the quality of the drugs destined for Africa because they're even worse than the drugs being sent to our market. And in fact, you know, the company had such a callous disregard for its patients in the developing world that when another U.S. executive brought up the issue of the quality of the HIV drugs for Africa, she was told by a medical director of the company, who cares? It's just blacks dying.
DAVIES: Wow. Let's talk a little bit about inspections that the Food and Drug Administration - the American Food and Drug Administrations - conducts on generic drug manufacturing sites in India. I think you mentioned this before. The rules are different from the inspections there from inspections in the state. How are they different?
EBAN: Well, the regulations, first of all, are exactly the same. The plants have to follow what are called current good manufacturing practices, which are, you know, a very elaborate architecture of regulations that basically say the process is the ultimate quality of the drug. You have to document every single step of the manufacturing process, and that data is sacrosanct and key to the final quality. And without that data, no drug can be deemed safe. So it's kind of a blueprint, a sort of PET scan of the quality of your drug.
So the rules are exactly the same, but the procedure is different. And what the FDA decided, in order to deal with logistics of overseas inspections, is they announce these inspections weeks, sometimes months, in advance. So these plants know that they're coming. I discovered they would actually organize data fabrication teams that would come in, alter documents, shred them, invent them - in some cases, even steaming them overnight to make them look old.
So there is an - a sort of elaborate preparation. You know, as one inspector told me, with low-cost labor, they can put up a building in a weekend if they need to.
DAVIES: And you know this because you got to know some inspectors. And some who were really dedicated - one is a guy named Peter Baker - did a lot of inspections in India. Apart from the restrictions of having to announce his visits long in advance, what were some of the other problems he faced when he encountered executives there, for example, who didn't like what he found?
EBAN: He was threatened. They didn't like his observations. He was - in one instance, he felt physically threatened. In several instances I documented, the investigators were poisoned in the course of their inspections with tainted water from the tap, which you can't drink in India. They felt sick during inspections. I mean, and this was a way of running out the clock. They were followed.
In one instance, an investigator had his hotel room bugged. They scanned - in some cases that I'd heard about - were trying to scan passenger lists in airports to try to determine exactly who was coming when. So there were elaborate measures that the plants took to try to protect against bad inspections.
DAVIES: Right. So inspectors find very troubling things in these plants. Does the FDA act seriously on the information they get?
EBAN: Well, this is really the part of it, to me, that is almost most extraordinary. So in some cases, when the findings are egregious, the FDA responded by imposing what's called an import alert, which essentially shuts down the plants' exports to the U.S. market, which is a very, you know, strong regulatory response and appropriate if the plant is committing fraud and you can't really vouch for the quality of the drugs.
But in other instances and in documents I've obtained, it looks like the FDA is really, across the board, downgrading the investigators' findings. The investigators go in. They find deception. They find fraud. They recommend something called official action indicated, which means the plant needs to immediately correct, or they face a warning letter or import alert.
But what the officials back in Maryland were doing with some of these findings is downgrading them to voluntary action indicated, which says to the plant, fix it, but not on an emergency basis, which means that those drugs - in instances where there may be deception, may be dangers - those drugs continue to come into the U.S.
DAVIES: Are they just overwhelmed, under-resourced for the task?
EBAN: They're overwhelmed and under-resourced and don't want to create a public panic. But they have - in my view, from all this reporting I've done - really failed to rethink their approach to foreign inspections because their investigators know that they're being fooled and tricked. And whistleblowers are writing into the FDA and saying, you're being fooled and tricked. Those are documents that I have in my file cabinet. But in the view of this, they're not revamping their inspection program.
DAVIES: Katherine Eban's new book is "Bottle Of Lies: The Inside Story Of The Generic Drug Boom." We'll talk more after a break. This is FRESH AIR.
(SOUNDBITE OF PAQUITO D'RIVERA'S "CONTRADANZA")
DAVIES: This is FRESH AIR, and we're speaking with Katherine Eban. She's an investigative journalist who spent years covering the pharmaceutical industry. Her new book, which explores problems with the safety and effectiveness of generic drugs, is called "Bottle Of Lies."
I wanted to come back to this story. You write about this young man, Dinesh Thakur, and how he had discovered widespread fraud in this Indian generic drugmaker Ranbaxy. And he has a conscience and thinks he has to do something. He considers going to the FDA. And it took a while for him to get the FDA's attention, but he did.
And this ended up in a nine-year saga - right? - which, I will tell the listeners, is a gripping read in this book. We can't go over it all here, but he eventually supplies the FDA with all kinds of information and documentation. Federal prosecutors eventually get involved. They actually raid Ranbaxy's American headquarters. And after a long, long saga, in 2013, the company pleads guilty in a settlement to seven criminal counts of selling adulterated drugs and pays $500 million in fines and other costs.
Having studied the whole thing, how would you assess the FDA's response and that of the rest of the government? - because they weren't in this alone.
EBAN: On the one hand, the FDA was the only regulator that responded to Thakur and launched an investigation in the wake of his allegations. But on the other hand, you know, it took them from 2005 to 2013 to bring this company to heel. In the middle of that, they give Ranbaxy approval for the biggest U.S. generic drug launch in history to make generic Lipitor, even though they know that this company is saturated with fraud. And about a year after that manufacturing begins, millions of Lipitor drugs have to be recalled because they're saturated with glass fragments.
DAVIES: From Ranbaxy.
EBAN: From Ranbaxy. That's right. In the middle of that, they're doing preannounced inspections in Ranbaxy's manufacturing facilities. So you know, what I found was - while not necessarily outright corruption at the FDA, I found a deep sort of mission confusion about what their job is and how aggressive they want to be in terms of protecting public health.
DAVIES: You obviously talked to a lot of FDA officials. I mean, we don't have them on this program. What's their defense?
EBAN: I don't know that they actually have one. I mean, what they say is they like to talk about their complex, risk-based surveillance systems, their prioritizing of public health. They love their numbers. They will talk about the increase in inspections. So, you know, from where they sit, they're not so much defending as saying that the system is working and everything is fine.
DAVIES: A lot of the book focuses on Ranbaxy, this Indian drug manufacturer. And, you know, once the FDA pursued a criminal case there, the self-assessment report from - what was it? - 2003, which showed widespread fraud in data on, you know, hundreds of drugs the company was making, became known to regulators. And that led to the company pleading guilty and paying a fine. What became of the company? Are they still around? Are their processes improved at all? Do we know?
EBAN: So Ranbaxy no longer technically exists today. It was initially purchased by a company called Daiichi Sankyo, which was Japanese. And basically, when they realized that the company was sold to them under sort of fraudulent premises, which is that the self-assessment report was concealed from them, they ended up taking the initial - the CEO of the company to an arbitration court in Singapore. They sold off the company to another generic drug company in India called Sun Pharma. So it's been absorbed. And, you know, Ranbaxy was India's largest drug company, which no longer exists today, largely because of the actions of Dinesh Thakur.
DAVIES: President Trump has made a point of saying the government needs to have fewer of what he regards as burdensome and job-killing regulations. Have you noticed the difference since President Trump was inaugurated in regulatory attitudes at the Food and Drug Administration?
EBAN: Once you understand how vital these regulators are to safety and well-being, basically any sane American is not going to want to take a pill that's coming from a plant that's uninspected. These regulators are doing absolutely vital work, and you can't go into this and come out thinking you want less regulation. I mean, it is too perilous. And the costs of having, you know, non-sterile plants, non-bioequivalent drugs, that cost is just too high.
But definitely, I think under the Trump administration, you do see a more lenient attitude towards corporations, generally, which, you know, has sort of trickled down to the FDA. But on the other hand, looking at the whole picture, I would have to call this a bipartisan failure that is really just - has not thought through in a systemic way how to respond to a drug supply in a globalized world.
DAVIES: Have these lapses in quality killed patients?
EBAN: You know, it's very hard to say that. But there are definitely doctors who feel that patients in very compromised, jeopardized health situations got worse, and some died after being switched to generics. So for example, I talk about at the Cleveland Clinic, a doctor named Randall Starling, who's treating heart transplant patients. The Cleveland Clinic, based on a lot of information they obtained, decided not to buy a drug that prevents rejection of organs. And yet, you know, beyond their control, some of their patients were switched to that drug and showed signs of organ rejection and had to be readmitted through the emergency room. One of those patients did die.
Starling says it's hard to ascribe her death directly to that drug. But, you know, in his clinical experience, that drug is just a dangerous question mark and a procedure with no room for error.
DAVIES: How much should we worry? I mean, how often are we - is a generic drug likely to be ineffective or unsafe?
EBAN: One drug investigator said to me that he thinks the concern is higher for people on maintenance medications who are taking these drugs day in and day out. Those drugs may have toxic impurities. Those can build up in your liver. You may not know it, or you may be having side effects that you didn't think about before and then you realize, wait a second, I was switched to a different generic, or I was switched from a brand to a generic. So I think that, you know, once consumers start thinking about this as a factor and not just accepting FDA spin that everything's fine, I think they wake up to the fact that there may be consequences for them.
DAVIES: Do you take generic drugs yourself?
EBAN: I do, but I'm vigilant in demanding generics from certain manufacturers and not others.
DAVIES: And so what should we as consumers know to help to protect ourselves?
EBAN: Well, I think if you take a maintenance drug, it's worth knowing, what are the generic drug companies that make that drug? You can even find out that information in what's called the FDA Orange Book. Then if you've got a manufacturing name, right - so you can look on the dispensing label. You'll have the name - go into Google. Put in the name of that company and FDA warning letter. What has the FDA found out about this company? Has this company had drug recalls? You know, I mean, it is a bit of sleuthing, but if you're taking this medication day in and day out, it's worth it.
DAVIES: Well, Katherine Eban, thanks so much for speaking with us.
EBAN: Thank you so much for having me. It's a pleasure.
GROSS: Katherine Eban spoke with FRESH AIR's Dave Davies, who is also WHYY's senior reporter. Eban is the author of the new book, "Bottle Of Lies: The Inside Story Of The Generic Drug Boom." After a break, John Powers will review the second and final season of "Fleabag," which he describes as a comedy series about female desire, insecurity and anger. This is FRESH AIR.
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