Episode 5: Interview with Best-Selling Author Katherine Eban

Host Jim Fries speaks to Katherine Eban, contributing editor for Vanity Fair and a New York Times best-selling author, in the fifth episode of The Patient Safety Podcast. Eban walks Fries through her investigation into the criminal underbelly of generic drug manufacturing that eventually led to writing her best-selling book, Bottle of Lies: The Inside Story of the Generic Drug Boom. Discover what it takes to expose criminals in the global pharmaceutical world, and what lessons the industry has learned since Eban’s investigation.

Thank you to Rx-360: https://rx-360.org/ 

Thank you to our guest Katherine Eban: https://www.katherineeban.com


Read the Interview:

Jim (00:31):

Hi everybody. This is Jim Fries from Rx-360. Thank you so much for joining us today. Believe it or not, it’s episode five of our patient safety podcast. And, and for me today is a really special episode. It’s you know, first time I think I’ve had a guest where I’m not only a fan of, but also from an industry perspective. Incredibly I guess if you want to say I admire Katherine for what she’s been able to do. And from an introduction standpoint, I really want to take a moment right now to introduce Katherine Eban. She’s a, in my mind, a world renowned investigative journalist studied at Brown University was a Rhodes Scholar at Oxford. And really in my mind has, has for lack of a better term, I think helped the pharmaceutical industry in understanding the importance of quality of our products in helping us understand how important patient safety is.

Jim (01:31):

And, and her latest book Bottle of Lies is something that is incredibly near and dear to my heart. I think I’ve read it a couple times now and, you know, for, from a, from a pure print transparency moment, I actually got it for everybody that works at Rx-360. So everybody on the team is absorbing the book, but really what I want to do is say, thank you, Katherine, thanks for being here. And why don’t you kick us off by kind of giving us a little overview of what the book really is about?

Katherine (02:00):

So the book takes readers sort of deep into the heart of the generic drug industry, much of which operates overseas and it exposes endemic fraud in that industry, particularly data fraud which goes to the heart of quality. So the manipulation of data in order to get approvals from regulators and to do all of that, it’s, it’s a story. It tells the story of particularly one very brave whistleblower Dinesh Thakur and how he brought down the company Ranbaxy for data fraud, but it also follows FDA regulators patients, doctors sort of through this Labine industry that has really just not been examined, scrutinized in any significant way beforehand.

Jim (03:03):

Yeah. And I think for me, Katherine, when I was reading the book the first time, one of the things that smacked me in the side of the head and you just referenced, it was this whole idea of data integrity because it was, it was when I was really starting to integrate myself into, to Rx-360, we do a lot with data integrity. And I said, my gosh, that really, to me, when I read your book, it painted that picture of how important data integrity is. Yeah. But when I, when I looked at the book and I started reading it and I tried to put myself in your shoes almost, and, and one of the big questions I had for you, and I’ve never had a chance to ask this of you, is what was that watershed moment where you started gathering some of this information? And you said, holy cow, I, I need to write a book about this story needs to get out where, talk to me about that moment.

Katherine (03:53):

Yeah, well, you know, I’m, I’m a journalist who’s never really satisfied or almost never satisfied that I’ve gotten to the bottom of something. The reporting for this began back in 2008, when a radio show host a guy named Joe Grayden who hosts the, the people’s pharmacy on NPR, he called me up and said that there were all these patients complaining about the effects side effects of their generics, the, you know, what the effectiveness of their generics. And he had posed this question to me, what is wrong with the drugs? I began investigating. And it took me a long time, but I uncovered the story of Ranbaxy India’s largest drug company which was basically just an ongoing crime scene. They had, you know, pressed hundreds of employees into this scheme of falsifying data and Dinesh Thakur ended up bringing down the company in 2013, they pleaded guilty to seven felonies for data falsification. And I issued a big article in fortune magazine. That blew the lid off that whole story. But after that, I just had another question was Ranbaxy an outlier, just the most corrupt drug company ever, or was it the tip of the iceberg? Was this something about how the industry functioned? And it was that question that made me feel that there was more reporting to do, and probably a book in all of this.

Jim (05:43):

Great, thanks. And I, I can appreciate that because that’s something that we live and breathe every day at Rx-360, by thinking about, you know, our, our, our membership, how we look at material quality, how we think about patient safety. It’s something that, you know, is ingrained in us. And, and a lot of, I know a lot of the people that have been involved with Rx-360 for years, really kind of in, in many cases have even pointed me towards some of the things in your book that allow us to, to really understand why people like you, people like Dinesh, people like Rx-360 really exist to help the industry.

Katherine (06:22):


Jim (06:23):

Because I think that’s the, that’s the message that I’ve had for people is we’re not, we’re not in this to, you know, there’s, we’re not in, in this to identify bad guys or jump on the bad guys were in this to make the, the industry better. And ultimately helps our patients. Since you started kind of this investigative roller coaster. So to say, when it comes to, to what you found with generic drugs during that time period, you know, did you, did you see you know, if there was the, the negative around your primary case study, did you see positives in the industry as you were writing it? Did you see where there were things being improved or even since the book has come out, have you seen improvements?

Katherine (07:16):

So I think that you know, one of the obligations of a journalist is always to be fair which I very much endeavored to do. And I wanted to make sure that I, you know, found the positive in this industry. And there is a tremendous amount of positive. I mean, I think, you know, generic drugs have aided humanity in many, many ways. But you know, as I began to ask myself that question about the book, I was actually surprised that, yeah, there is so much of fraud here that needs to be exposed. But after the book came out, I would say I did see some significant changes or the beginning of changes in the industry. And one thing that I have seen, I would say two things I’ve seen. One is a drive for more transparency, from a number of companies that basically want to be the company that gives patients more information that tries to disclose where they manufacture drugs that has sort of lobbied on behalf of more disclosures and transparency.

Katherine (08:40):

But I would say the other positive thing in the industry is more drive towards verification of quality. This idea that, you know, the FDA, even though yes, if it says that something is fine, it is presumed that it is fine, but there are, there’s a real drive for companies now to say, you know what, we are gonna continue to verify this. We’re gonna continue to test. And so you’ve seen new models, like Valisure, you know, where the, the pharmacy, the checks. I think that there is a lot of room for companies to distinguish themselves as conducting independent verification of quality. I think that’s what we’re gonna be seeing hopefully in the next 10 years is a real movement toward that. So I would say to me that is the single biggest positive IC.

Jim (09:43):

Yeah. And I see the same thing too. I mean, I know working every day with our Rx-360 membership, we see that that pivot towards, you know, people wanting to make sure that their T’s are crossed in their I’s are dotted, especially, you know, per your book. I really see a big movement in that area of data integrity. So that’s really important and exciting for me because it almost, it, it ties the two together. Yeah. People that know me, Katherine, they always hear me say Hey, paint me a picture, paint me a picture of something. And, and, you know, reading the book there, there’s a lot of case examples. Studies stories, can you share with, with me, with the audience, you know, maybe a story that is in the book or an example of something where you had that moment of going holy cow, I can’t believe I’m, I’m, I’m seeing this. Can, can you share one story to maybe help paint a picture?

Katherine (10:36):

Sure. I mean, there’s, there’s a lot of stories there, but I mean, just take the opening scene of the book where an FDA investigator, Peter Baker shows up at a manufacturing plant in India to do an inspection. And he is walking down the hall of this supposedly a septic plant. And suddenly he sees an employee in front of him holding a garbage bag and sort of trying to scoot toward the exit of the plant and he speeds up and the guy speeds up and then they’re involved in this low speed chase down this hallway. And of course inside of the garbage bag are records of like hidden defects and a whole, they relate to a whole part of the plant that wasn’t even, they didn’t even alert them to. And he’s trying to smuggle out these records before the FDA catches them. And I just thought to myself, you know, not only are these plants, sometimes crime scenes, but there’s even like low speed chases through the hallways. So that was one of the, you know, just, that was one of many stories where I just thought, you know, this is why I’m, I’m a journalist and not a fiction writer cuz you can’t even make this stuff up.

Jim (12:10):

Right. I know one of the things that crossed my mind when I, when I read that part and really thought about some of the other things that you detail in the book is, is how hard it is. I, I mean, I sympathize with the role of the auditor, whether it’s an auditor for the FDA or, or an auditor for the, you know, private sector, it’s, it’s these people that go into these facilities to, to do those quality audits, they have a Yemen’s job and it is, it is. I applaud them kind of on a daily basis cus I know just for my expertise, it’s not something that I could do. And when I, when I sit back and read an audit reporter, you know, again, read your book. It really, I think is an industry from an auditing perspective, those people that go out there and do those audits, we, we have a debt of gratitude towards them from a patient safety perspective.

Jim (13:02):

When, when you look at the whole idea and I, I know you just told the story about the FDA person running down the hallway. When you think about regulatory authorities, when you think about pharmaceutical companies and their internal quality departments, you know, where, where do you think we can, from what you learned and, and putting on your, your kind of crystal ball type of thing, what do we still have to learn? What do you think that we still have to get better at? You know, can you give us a little insight on, on, you know, we talked a little bit before about improvements that maybe you’ve seen, but what do we, especially from a regulatory perspective, how, how do you think we need to make the system work better?

Katherine (13:43):

Well, you know, one question that I always have when I’m reporting on these issues is, are people who work inside the plant genuinely empowered to bring forward concerns about quality? You know, one of the, one of the huge problems in these Indian manufacturing plants where there’s a very sort of rigid hierarchy is there’s no room for sort of second guessing and raising concerns. And that is always an environment where quality is going to suffer even very seriously suffer because all that, basically the, you know, directions that the people who work there are being given is just, you know, make it work, make it work, which means, and then that’s a kind of directive where data starts getting falsified because they have to make it work. You know, so, you know, I can’t tell you how many individuals in the pharmaceutical industry who work in the quality departments end up contacting me because they feel they’ve exhausted every other option. And they’re genuinely concerned about safety in the plant. You know, because they’ve brought forward issues and concerns and they’ve either been sidelined or demoted or silenced. And you absolutely need to have an environment where you empower the most conscientious, concerned employees, you know, they’re your eyes and ears. So you know, how can that be made to happen inside of the manufacturing industry? That’s a very critical question to me.

Jim (15:37):

And, and, and, you know, just to kind of, you know, I guess if I want to say, make you feel a little bit better or, or always give you some hope for, for some of those observations that you made. I mentioned before about one of the working or discussion groups that Rx-360 has is based around data integrity. One of our other groups that we have is actually international based it’s specific to India. And I can share with you Katherine, the, the people from the, the Indian based pharmaceutical companies that call to that discussion group really are engaged in making the system better. And it’s been really impactful and, and eye opening for me that makes me feel really good when I see Rx-360 members talking in those terms, it’s always about, Hey, what can we do better? So that’s exciting to me between those two elements that you brought forth in your book.

Jim (16:25):

One of the things I wanted to ask you too, is we’re kind of, you know, start thinking about wrapping up our discussion here, but when you also think about what’s next, you know, coming out of bottle of lies and, and thinking about, you know, we just talked about the, the, the pressures of the auditor. You just brought up the pressures of the people working in the plants. You know, those pressures aren’t gonna go away because the pharmaceutical industry continues to move a million miles an hour. But I think us having this type of conversation and things that you’ve done, I recently saw you speak down in Florida, but, but you know, those type of events and these type of platforms, I think allow people to recognize maybe where some of those pressures are and figure out, okay, how can we alleviate some of those pressures and make it a little bit more transparent? Right. When we look at the regulatory agencies, when we look at the internal quality departments, do you think they think like that?

Katherine (17:32):

Well, you know, the regulatory agencies, I mean, like the FDA, for example their mantra has very much been you know, instilling a culture of compliance into companies. You know, and they have also, at least when I started reporting bottle of lies, regulated on an honor system, you know, they would review company data. There’s not a lot of independent testing. And you know, they, they also would pre announce inspections going overseas. And I think there has maybe slowly been a recognition that you can trust, but you have to verify, you have to have a system of independent verification whether or not, you know, however much you want to promote corporate compliance. And that’s a wonderful buzzword, but it’s not sufficient. The, when I first started reporting and I went down to the FDA headquarters and we sat around this conference table and the head of the office of generic drugs said to me the approval system requires the ethical behavior of the applicant. Otherwise the whole house of cards will fall down. I was like, wow, well, what if the applicant is not ethical? You know, and that’s, that’s a reality. So I would say that, you know, independent verification is what everybody has to do. Yep.

Jim (19:18):

Yeah. And, one of the things that gave me incredible encouragement, because there, I know there was a big concern, you know, actually I talked to people, you know, hindsight’s always 2020, right? So you talk to people about the effects on quality and patient safety and, and, and auditing that were brought to the surface because of COVID 19. And all of a sudden we couldn’t get into plants. We couldn’t, right. We couldn’t do onsite audits. I was incredibly impressed at least from the Rx-360 perspective. And I think it was industry wide is how everybody jumped on board and came up with best practices on how to do it remotely or virtually. Now, now, granted, it’s probably not always gonna be as efficient as being on site, but boy, that was something that really, really impressed me of how the industry jumped on that and said, how can we work together to make sure that, that those gaps that may exist aren’t widened or things don’t fall through the cracks because otherwise, I mean, you could add the basis for a whole ‘nother book.

Katherine (20:25):

Oh yeah. For Sure.

Jim (20:26):

Good deal. Well, Katherine, what I want to do is, kind of wrap up here. Two things. Number one is, I have a copy of your book here. I want to make sure that everybody that’s watching this on video sees the book and, you know, feel free to go out and get it. It’s a wonderful book. And, and it’s something that I highly recommend, not only for people in the industry, but for people that aren’t even in the industry. And then I really wanted to, besides thanking you and your time, any closing thoughts, any, any, any message that you want to leave people, whether it’s in regards to something you learned about the book, the industry, anything, I mean, just any closing words from you?

Katherine (21:07):

You know, I would say that there’s, you know, I’m struck all the time by how many incredibly thoughtful people there are in this industry who are just passionate about quality and protecting patients. And I do think that, you know, all of the ingredients are there for, you know, very safe and high quality products. And I do think that it comes down in many ways to company culture and executive leadership which is incredibly important. And, you know, the messages that are sent to employees about what a company values can make a big difference. So I think that is, to me, a takeaway and something to consider.

Jim (22:02):

Katherine, I could not have said that better and I 1000% agree. So really on behalf of myself and the entire Rx-360 community, I want to thank you for being with us today. And I look forward to doing something with you in the future. Thank you very much.

Katherine (22:16):

Thanks. Thanks for having me, Jim. It was a lot of fun.