What makes people tick? What are the stories they carry with them? In a world of shouting heads, veteran journalist, radio commentator and novelist Sandip Roy sits down to have real conversations about the fascinating world around us and the people who shape it. Catch these engaging interviews every other Sunday
In this episode, Sandip talks to Katherine Eban, an American journalist, whose bestselling book, Bottle of Lies, documents and exposes global fraud, large-scale data fabrication and unsafe practices inside Indian drug plants, including one of the biggest Indian pharmaceutical companies – Ranbaxy.
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Sandip Roy: Hello and welcome to the Sandip Roy Show on Express Audio.
Over 10 years ago in 2008, Katherine Eban, an American investigative journalist, got a call from the host of a radio programme called People's Pharmacy. The host needed help. Patients had been calling in saying they'd been taking generic drugs for all kinds of issues, from depression to heart disease, and the drugs were not working or had terrible side effects. But these were all legit drugs approved by the Food and Drug Administration or FDA in the US, which insisted that they were fine. Eban started following the stories and it led all the way from America to India, where the drugs were being manufactured and especially to one very famous Indian pharma company - Ranbaxy. What she uncovered about the pills we take was not pretty, and it is documented in her book, Bottle of Lies: Ranbaxy and the Dark Side of Indian Pharma.
Katherine Eban, welcome to the show.
Katherine Eban: Thanks so much for having me.
Sandip Roy: In your book, there are many characters but central one is this whistleblower named Dinesh Thakur who worked at Ranbaxy. Could you tell us a little bit about what the Dinesh Thakur was worried about?
Katherine Eban: So his boss, Dr. Raj Kumar grew concerned that the data that Ranbaxy was submitting to regulators may have been fabricated. So he gave Dinesh a really remarkable assignment. He asked him to investigate all of Ranbaxy global regulatory filings and try to figure out what data was real and which was fake. And Dinesh took his team. He did the research and he really uncovered a global crime. He figured out that over 200 drug products in more than 40 countries had been filed with fabricated data. And that information was submitted to Ranbaxy's board of directors. And their response was basically to recommend a cover up. That the information should be destroyed, the computer should be destroyed. Thakur's boss quit the company and then Thakur was forced out. So he was thinking about the dangers of the drugs that Ranbaxy was making, which were going all over the world. Nobody knew whether they worked or not. And so he ended up taking his information and his documents, and he did keep backups, to the US FDA. And on the basis of that they launched an eight year investigation and ultimately brought down the company.
Sandip Roy: Was it typical that the investigation took that long? Or was it a particularly challenging one for the FDA? I mean, he was presenting all this fake data. So in some ways, you would think, like, oh, this should be slam dunk.
Katherine Eban: You know, you really should. And it's highly unusual that an investigation would take that long. I think partly, the FDA could not wrap its mind around the fact that everything in this company seemed to be fake. So they were trying to sort that out. You know but the other problem is, the company is headquartered in India and the US FDA has no particular jurisdiction there. We don't have attorneys general, we can't do search warrants, we can't interview witnesses. So that all became part of the problem
Sandip Roy: And you writing that while all this is going on, while people at FDA, many people are very concerned about the data in Ranbaxy, the company is continuing to ship over 60 products that had been approved based on fake data. So it's like the FDA knows that these products are based on fake data, but they are still continuing to ship and they are approving other ones, too.
Katherine Eban: That is one of the mind boggling parts of this story. You know, if the data is fake and the drugs are bad, why not block them? So really, this is part of the book...the corruption and failures within FDA to bring Ranbaxy to justice, to stop the drugs from coming into the country. You know, partly the issue is the political pressure that our regulators are under to continue approving low cost drugs. And you know, as I came to think about Ranbaxy, it's almost like it was too big to fail.
Sandip Roy: Yeah, because this is not a story about some bad apples within Ranbaxy. In your book, it sounds like the rot was systemic. The Ranbaxy itself was the bad apple in that way.
Katherine Eban: Absolutely. I mean, fraud was the way that the company operated. The FDA knew it. They had all the documents and yet they even gave Ranbaxy approval to launch the US's biggest generic in history, generic Lipitor. On the basis of that launch, in the middle of this criminal investigation, Ranbaxy made $600 million in six months. And in fact, when they started shipping generic Lipitor, they made 100 million dollars in 24 hours.
Sandip Roy: Wow. So what was some of the ways Ranbaxy was manipulating its manufacturing process to produce this impressive looking data?
Katherine Eban: One of the ways that I described in the book is what was called 'suitcase drugs'. So when they had data that they had to file with regulators, they got their executives to smuggle in drug samples in suitcases, and they use those drugs to run data off of and make it look like it was their drugs. So they were even running data off of brand name drugs, and submitting those to regulators as if that was their own data. And those drugs that they used to run the data were being smuggled in by executives in suitcases
Sandip Roy: And Ranbaxy was the first company in Indian pharma to get a plant approved by the FDA to make products for the US market. And you say that, by 2005 the FDA had more drug plans to inspect abroad than it did within us borders. So how often does the FDA actually inspect these generic drug plants in places like India or China or wherever?
Katherine Eban: So when I first started reporting this book, it was very infrequently they would maybe go to a plant every 10 years. But because of legislation in the US, they started doing it more frequently about once every two years. But the problem with the inspections is this. In the US, the FDA shows up unannounced, and they stay as long as they need and they inspect the plants overseas because of complex logistics and visas. They're giving these plants months of advance notice that they're coming. So as I uncovered some of the plants actually operate, data fabrication teams that come in in advance of these visits. They shred documents, they invent documents, mean in one instance, at Ranbaxy, they invented a standard operating procedures and then steamed them overnight in a sauna like room to make them look old. So it is really creating a facade of compliance. And that is completely fake. In order to fool the regulators.
Sandip Roy: And the inspectors, kind of to my astonishment, they practically have to be like cowboys or...you know, it's like a thriller cat and mouse game...where they...can you talk about that?
Katherine Eban: It is absolutely a cat and mouse game. And in fact, the book opens when Peter Baker, who's a young FDA investigator, arrives at a plant run by Wockhardt, another big generic company in India. So he arrives and they know he's coming. They fixed up the plant, but they weren't prepared for him. Because he was someone who refused to be led through the plant, wouldn't go through a welcome ceremony, an opening slide show, he went wherever he wanted. And on the second day at the plant, he sees an employee with a clear garbage bag that has documents in it. And he orders the man to stop and he doesn't. And there's a chase scene down a hallway and the man hurls the garbage bag. Peter Baker goes and retrieves it. And in the bag, he finds ripped torn batch production records. And those records reveal that there had been metallic fragments in vials of insulin, which the plant nonetheless cleared for shipment to patients. And it got worse from there.
Sandip Roy: But Peter Baker also says at one point that, you know, many of these people who work in these plants, some of them kind of in somewhat remote places, in their daily lives they lack access to toilets and running water. So he said, it seems ludicrous to expect that they could just walk into what needed to be a sterile manufacturing plant and suddenly be able to follow all these rules.
Katherine Eban: Yeah, I'm what he's seeing is that, in fact, many of the workers at these plants are illiterate. You know, they can't read or write and yet they're required to follow written rules and sign off on forms. So that in some cases, the plants would simply put the answers up on the wall, what they're supposed to write and they would merely copy those. Every minute and every inch of a plant like that is highly regulated. So unless you have highly trained workers, there's no way that they can, you know, follow the appropriate rules.
Sandip Roy: And have you seen photographs of some of the things these inspectors found?
Katherine Eban: Oh yes, I have. I mean, I've seen photographs of birds and monkeys and snakes inside these plants. You know, bird droppings on top of what should be sterile vats of active pharmaceutical ingredient. In one instance, a photograph of someone hiding active ingredient that is not approved above ceiling tiles. I've seen images of bathrooms with no drainage piping or water or soap, you know, and this is all going on in the context of sterile plants.
Sandip Roy: So the FDA and its inspectors are uncovering these things for drugs that are meant to go to America. What was happening to drugs that Ranbaxy was sending to the rest of the world, as well as India itself?
Katherine Eban: That is really I think, the most troubling part of this story. I mean, there's no question that Americans got substandard drugs from Ranbaxy, but really the quality of drugs for the rest of the world was markedly worse. So for example, there is one exchange in the book where Dinesh Thakur asks someone inside the company, 'how much of the data submitted to Indian regulators for the Indian market, how much of that is fake?' And the answer is a 100%. It's all fake. And the explanation was, we don't even bother to test the drugs and create real data because nobody ever looks at it. So what that means is that Indian consumers are getting some of the worst drugs that the company makes, as well as consumers in Africa. I mean, that was a very troubling part of this story. Ranbaxy was making some of its worst drugs to send to Africa to treat AIDS patients. And when an American scientist who worked for the company brought that up in a company conference call, the medical director responded, 'Who cares, it's just blacks dying'.
Sandip Roy: And the thing is, the story of generics, for laypersons like me, it really came to the news because of Africa and AIDS in Africa. When companies in India like Cipla said that they would try and provide AIDS cocktails for, you know, for $1 a day. Whereas then the big pharma companies, you know, had these patents and it was so expensive and thousands and thousands of people were dying in Africa. And at that time, it was sort of the generic good guy, that sort of David's taking on the Big Pharma Goliath. How did this flip?
Katherine Eban: Well, you know, that is a really heroic part of this story. What Cipla and Yusuf Hamied and, you know, some of the companies did to make AIDS drugs affordable, that battle is so important and I documented in the book. I think what happened is, the Western markets became opened up to Indian companies really after that. And there was a race for profits, there was a race to be first on the market. And a system was developed to fool regulators, to evade regulations and fortunes were being made in that way.
Sandip Roy: And in India, as you say, there is something called the CDSEO, which is sort of the Indian equivalent of the FDA. But I have to admit, I'd never even heard of it. So what is its role in all of this?
Katherine Eban: Well, there's the role it should have and the role it should have is to regulate these companies. But then there is the reality which is, and as it's been described to me by very knowledgeable people, it is more playing a role of protecting the companies instead of actually inspecting them. So for example, while US authorities were having Ranbaxy plead guilty to seven felonies for faking data in the US, CDSEO did nothing. They didn't do any extra inspection, any testing, any recalls. Their reaction to all of that was - nothing really to see here. You know, and as GN Singh, who was the former head of CDSEO, told one Indian journalist, you know, 'If these plants had to meet American standards, we'd have to close them all'.
Sandip Roy: Well, and maybe they would have had to. But it's also kind of shocking that when somebody like a Danish Thakur goes to some of these authorities here, he's sort of called 'anti-national', a term we hear a lot these days, because he's actually an American citizen now. And in India, I think what most of us don't realise is, there's no protection really for a whistleblower in the way there is in America.
Katherine Eban: You know, what Dinesh Thakur has done and the fight he continues to lead is really heroic. And I think what an Indian audience should understand is that he is fighting for Indian patients and consumers. I mean he is trying to demand that Indian regulators become vigilant. Truly vigilant about the quality of drugs on the market, many of which are substandard. But that just hasn't happened here and he risked his life to bring the truth about Ranbaxy to light. You know, there is no protection for Indian whistleblowers, as you say, many of them end up meeting very unfortunate ends. I will say that, you know, the world is watching the current impeachment battle in Washington DC which was sparked by revelations from a whistleblower. And I think even in the United States, you see less and less governmental support for whistleblowers, but their actions are courageous nonetheless.
Sandip Roy: I mean, it does get quite dangerous at one point Dinesh Thakur is sort of accused of browsing porn on the computer's networks, as a way to sort of discredit him. And far worse happens to other people.
Katherine Eban: That's right. I mean, after this, just devastating PowerPoint of his findings was shown to the board of directors, and they opted for a cover up, they then tried to force Dinesh out of the company by planting porn on his computer. It was clear to him that he had to leave and, you know, he had assumed that that would be it for him. He'd leave the company and move on. But in fact, he couldn't move on because he kept thinking about how perilous these drugs were for the rest of the world.
Sandip Roy: This case goes on for years. There is a huge settlement, $500 million dollars, but no one faced criminal charges for what they did.
Katherine Eban: You know, probably the only way to send a message to pharmaceutical companies, in a way that they understand, is to start criminally charging their executives. But as you say, that did not happen in the Ranbaxy case. I think partly because of all the jurisdictional issues, had they... I mean the book details how the most likely person to have faced criminal charges would have been Malvinder Singh, but in fact, the FDA's investigators never even interviewed him. And I think they were just frankly overwhelmed by a case in which witnesses and evidence is 7000 miles away.
Sandip Roy: So in your opinion, what exactly in the end did the Ranbaxy case accomplish?
Katherine Eban: Well, I think what Dinesh Thankur accomplished by bringing that fraud to light is he put this whole issue of data fraud on the public radar. It's a huge issue now in a way it just wouldn't have been. The phrase that they use inside the industry is 'data integrity'. And now what we see is a whole host of warning letters and import alerts on Indian companies. And in fact, there was just an article that posted today about how Indian companies have faced the most warning letters. So this issue and the problems of data integrity are now front and centre in the industry. And the US Congress is also looking into this issue, partly as subsequent to the publication of my book.
Sandip Roy: But Ranbaxy itself has been sold off to Sun Pharma. But was this, I mean...going back to the rotten apple, if it wasn't a few rotten apples in Ranbaxy or whether Ranbaxy was the rotten apple...but also is Ranbaxy just one rotten apple or are there many more Ranbaxys out there?
Katherine Eban: Well, that is really the central question that propelled me to write this book. I mean, I came out with a big article about Ranbaxy in 2013. But then my next question was, was Ranbaxy an outlier or the tip of the iceberg? And that is really, in my view, what the book exposes. I mean, it takes a deep dive into the industry and it shows that data fraud is really endemic. You know, this is how the industry has operated in order to maximise profits and go maximum speed to market. This is a kind of operating playbook that they have had. Obviously, there are more ethical companies and less ethical companies, but the US FDA has absolutely caught a number of companies committing fraud.
Sandip Roy: The Indian pharmaceutical alliance has, in response to your book, it has said that, oh, the information in this book is dated and that the IPA members are actually fully committed to global standards of quality. What's your response to that?
Katherine Eban: Well, you know, my response is that the book actually runs up to 2018. The entire last third of the book follows Peter Baker, the FDA investigator, as he goes into a variety of other companies not including Ranbaxy and exposes fraud by looking directly in the computer systems. So I recognise that what the alliance is saying is their spin and their talking points, but that's not actually the truth.
Sandip Roy: But then as a consumer, I'm screwed either way. You know, either you pay for very high priced brand names or you do generic. And the FDA too, I can see, is in a bind because in the end, when you're trying to keep healthcare costs down, it's actually once more generic out there.
Katherine Eban: It's a tremendous problem for consumers. It's not unsolvable. But it's a huge problem. And I think the dilemma for consumers is a little bit different in the US and India. But the outlines are essentially the same. You know, which is that people cannot afford brand name drugs, we need generics, but how do you know that you're getting a quality generic as opposed to one that is being made with, you know, fabricated data. And really, the only guarantee of that is the vigilance of the regulators. You know, that is what is going to protect consumers, is when companies fear regulators. And when there are significant penalties for misconduct. And unfortunately, in that instance, I think that Indian consumers are really more disadvantaged because your regulators here are not really taking on the industry, they're more partnering with the industry.
Sandip Roy: Is there something cultural here too? Because in India, people have grown up companies, all companies have grown up under something called the 'Licence Raj'. Where it was just part of doing business that you needed to, you know, bribe government officials to get paperwork cleared. And it was all about managing the government and you had to game regulations in order to succeed and everybody sort of knew that. And now the same thing is happening to generics. Except the products they're producing are not plastics or things like that, but pills that we're taking and that are supposed to make us better.
Katherine Eban: It's an excellent question. I explore that issue in the book, the issue of culture. And it's also something that I heard about a lot as I was reporting the book and heard a lot about it from Indian executives in the pharma sector. One thing that I heard about is a word I didn't know before I started reporting this, jugaad. Essentially, the art of the shortcut. And while that can be, as I understand, has very positive connotations, it can have very negative ones as well. Which is basically the art of evading obstacles like regulations and getting to the desired goal in the shortest route possible. And, you know, that kind of attitude and approach, I think, is something that is really an issue in this context.
Sandip Roy: At the same time there are US State Department officials who are admonishing some of the investigators for acting like Cowboys, how do you respond to the accusation that there was anti Indian bias?
Katherine Eban: You know, I honestly don't unnecessarily see bias on the part of the investigators. I think they were responding to the conditions that they witnessed firsthand in these plants. But you know, there's an essential conflict between the goals of the State Department and the goals of the FDA. And the FDA's stated mission is to protect public health above all else. So, you know, the investigators saw themselves as, sort of, last man standing between potentially dangerous drugs and American consumers. And State Department and embassy officials are worried about diplomacy and relations. So given that essential conflict, I think it's worth asking, is this such a great idea? You know, globalisation poses a lot of challenges when it comes to getting consumers safe medications and diplomacy is sort of getting in the way of that mission of safety.
Sandip Roy: But aren't you concerned that somebody reading this book, in the end, will feel like look, I can't trust generics and I only want brand name branded drugs?
Katherine Eban: Because I got so many questions from readers about 'How can I know if my drugs are safe?' I actually posted a guide on my website, a guide to investigating your own drugs. And what I tell consumers is, what they need to do is look at who's making the drugs. And then I advise them to do a little research about the track record of the company making that drug. I mean, some of these companies have trails of warning letters and import alerts, and those are easily researchable. But that said, I do think it is unfortunate that consumers need to be Sherlock Holmes to figure out if their drugs are any good. It should be guaranteed.
Sandip Roy: There's an FDA official in the book who says 'As soon as I started the Ranbaxy case, I would not let anyone in my family take any Indian generics'. Do you think the whole industry is being unfairly tarred?
Katherine Eban: Um, I think that there are issues in the industry that need to be addressed. And I think until that happens there is going to continue to be data fraud. This is not to say that every company is operating this way. But, to give you an example, Peter Baker, the FDA investigator inspected 86 drug plants in India and China, over the course of four years, and he found some element of fraud in four-fifths of those plants. In 67 of those plants. So that tells me that there is a wider problem here.
Sandip Roy: Would you let anyone in your family take Indian generics?
Katherine Eban: You know, it depends on the company. So because of what I know, I think I have a pretty strong sense of which companies are operating with more ethical guidelines and which ones are not trustworthy. The other thing is that I've spoken with a lot of doctors who have given me feedback about the responses of their patients to drugs by different drug makers. I've spent 10 years reporting this, it's hard for an average patient to know that.
Sandip Roy: What kind of backlash have you faced? I'm sure these companies were not very happy to have all this put into a book.
Katherine Eban: They were not happy. That is true. So really, I faced a number of threats and risks, including legal threats, as the book was closing. Threats and difficulties in China, in India as well. But I will say this, which is the consumers, even though the book has news that is obviously not great for consumers, they have really welcomed the book. I mean, I've gotten wonderful feedback. They want this information. But there is no question that I have angered companies and made them unhappy.
Sandip Roy: Yeah, I assume when you landed in India pharma companies were not waiting at the airport with marigold garlands and 'Welcome to India' signs.
Katherine Eban: No, I haven't gotten those yet.
Sandip Roy: But now looking back, one of the things that felt most egregious to me was that despite all this, not only were there no criminal consequences for some of the people involved in this fraud, but most of these high powered officials sort of very much landed on their feet. They went from one Ranbaxy to some other major company.
Katherine Eban: You know, that is the big problem, which is if you're not stopping people through criminal prosecution, they have this skill set. They know how to fabricate data and they go on to other companies. So it's kind of like exporting crime. And you know, the big joke inside the FDA was 'If we want to see what company is going to be the next Ranbaxy, we're going to go look where these people have landed at their next jobs'.
Sandip Roy: Would somebody like that be looking at what happened to Ranbaxy and take the wrong lesson from it, which is 'How do I do data fraud better?'
Katherine Eban: You know, it's remarkable that you say that because in fact you can see from the sanctions that they are improving their methods to evade detection. So, for example, Peter Baker found metadata inside the computer systems from secret tests they'd done, which they then deleted. Because they were pre-testing the drugs to see the results to figure out how to tamper with the tests. Then they delete those pre tests, but he found trails of metadata in the audit trail. So he caught them doing that. So and then, the next step was they started literally crashing the computer systems so that they would be basically destroying the data from the pre-test and making them unreadable. Like, they called it 'crashing files', where they would literally pull the plug from the wall and crash the system. So as not to leave evidence of the deleted tests and the audit trails, but to corrupt the data instead. You know, so there is a kind of transformation and evolution of tactics.
Sandip Roy: And what kind of lessons do you think the FDA has drawn from this? You say this story has made people more aware, but has it changed the way they are doing drug inspections in India? You know, are they planning to do unannounced visits more?
Katherine Eban: It hasn't changed behaviour at the FDA yet, but there are ongoing congressional hearings now about this whole issue in the US. So this is very much an active question, you know, is how should the FDA be overhauling its foreign inspections? So there is oversight, there is debate and I think we have yet to see a resolution.
Sandip Roy: Because in the end, the healthcare system cannot do without generics. And you've said that roughly 40% of America's generics were manufactured in India and a full 80% of the active ingredients in all US drugs come from places like this.
Katherine Eban: Yeah, absolutely. I mean, our whole, you know, our health care system is a disaster. But it is absolutely dependent on these low cost drugs. So I think the question, you know, nobody is proposing getting rid of generics. The question is, how can we ensure high quality through regulation.
Sandip Roy: Are you hopeful?
Katherine Eban: Well, at the moment, Washington DC is such a swamp of dysfunction, I can't say that I hold out huge amounts of hope. But I do think that maybe better change would come through consumer awareness and a consumer revolution. That would give me hope.
Sandip Roy: Well, Katherine Eban thank you so much for writing this book and thank you for joining us.
Katherine Eban: Thank you. It's been a great pleasure to speak with you
Sandip Roy: Katherine Eban is the author of the best selling book, Bottle of Lies: Ranbaxy and the Dark Side of Indian Pharma. Leave us a review wherever you get your podcasts from. Find us on Facebook and Twitter and Instagram at Express Podcasts. Let us know what you think and stay healthy. Thanks for listening. This is Sandip Roy on Express Audio.