Inside story of the generic drug boom, and im talking to you today from massachusetts. Isually based in brooklyn, new york, but we are hunkering down in cape cod this summer. My book is a true cme expoe of the generic drug industry, and takes the reader deep into that distant manufacturing plant in india and china that make most of americas lowcost medicine. Heavily reported over the course of ten years, the book follows several key characters, and industry whistleblower, and fda investigator as they begin to uncover widespread fraud in these manufacturing plants. The question is, what made you want to pursue this topic . I and in Investigative Journalism and i been at this for several decades. But in 2008 i got an unusual phone call that came from a radio show host on npr. He has a show called the peoples pharmacy. His name is joe and he called me with a tip. He said listeners were called into his Radio Program and complaining about their generic drug, the film having side effects of the drugs seemed ineffective. When he took those complaints to the fda, the response he got back was that the reactions were probably psychosomatic and that patients were complaining because winter switch to generic those drugs look different than the usual drunks. He did not believe that. So he posed a question to me that i couldnt get out of my head, namely, what is wrong with the drugs . That is really whereby reporting began as an effort t answer that question. Some people have noted the book begins with the gandhi in india, which is qte remarkable. What does that have to do with generic drugs . It was world war ii, and the british were inndia of course, and they were having to fight german and was fighting all over the world, and theyeeded pharmaceutical supplies for eir army. At that point the indians wanted their independence from the british, so basically they went, e british went to gandhi and said, look, if you want independence, help us with pharmaceutical supplies for army, and we will consider giving you freedom. And so the prmaceuticals that the indians started manufacturing had the active ingredients they started making at that time grew into a giant industry in india, but it began actually with the bid for freedom. One of the main characters in the book is named dinesh come hes a young engineer. He was at Bristolmyers Squibb in new jersey, and an associate of his was going to india to work at indias Largest Drug Company at the time. And recruited dinesh to move his young family to india and join this company. So we does. He goes and he gets a new boss who is head of research and development. That boss begins to get worried about quality of the data that theyre filing with regulators around the world because in order to get drugs approved, you have to submit quality data to regulators saying that your drugs meet standards. His new boss, this was in roughly 2004, the new boss gives dinesh an assignment. Look into all of the worldwide regulatory filing and find out if the data is real or fake. Said dinesh takes his team, start delving into the filings come into the data and essentially uncovers the secret, which is that for 200 drug products, 44 countries around the world, it is just invented data. They just made updated in order to make substandard drugs look like they need quality. In the very sort of dramatic series of events, his findings are shown to the board of directors of the company which order his findings destroyed, the computer on which his findings are created destroyed, and the nash is forced out of the company. Through a series of events he decides to blow the whistle and takes this explosive information to the fda which then launches an eightyear investigation. And actions surrounding this form the core of the narrative of bottle of lies. So it might surprise people to know this, but 90 of the u. S. Drug supply is generic, and that means if you go to a pharmacy, almost certainly the subscription youre getting is a generic. Even more surprising to people is the fact that almost 80 of the active ingredient in all our drugs, brand or generic, are being manufactured overseas, principally in china and india. The majority of our finished dose generics are also coming from overseas, 40 of those those drugs alone are being made in india. Under fda regulations, any manufacturing plant that is sending its drugs into the u. S. Market has to be inspected by the fda. So on paper the system of regulation is identical but the reality is that when the fda inspects plants in the u. S. , they show up unannounced. They stay as long as needed. But because of all the complex logistics of overseas inspections, the fda will announce that it is coming months in advance for overseas inspections. So that gives manufacturing plants the opportunity to clean up, which they do. One of the things that i expose is how they send data fabrication teams into these plants when they have advanced notice, which they routinely do, and they will make up documents. They will backdate documents. They will shred documents. They will sometimes even create new documents and steam them overnight in a sauna room to make them look old, is one example that i uncovered. The question is not just are they required to inspect, what is the quality of those inspections . Right off the bat you have a very different situation. It goes downhill from there. One of the things i uncovered is that the industry uses a system that essentially amounts to adjusting the quality of the drugs depend on the market they are shipping into. They may use their better ingredients and more safeguards for drugs that are being sent to the u. S. Or europe, and actually worse drugs, fewer safeguards, poor Quality Ingredients for drugs being sent to africa. Sometimes they will invent all the quality data of the drugs being sent to africa, which essentially means that people in those markets are getting completely untested and unproven medication. The manufacturing standards essentially are amounting to whatever they can get away with, which is really very troubling. There is one anecdote in the book where a u. S. Scientist who had joined the company ranbaxy in india was very troubled or concerned about the quality of the aids drugs bad for africa, she raised it on a Conference Call with company executives. The medical director of the company said who cares . Its just blacks dying. And that gave her a very vivid understanding of the standards and ethics of the company. Some people have said this is just an antigenerics book, and thats actually the case because it really does have profound implications for big pharma. So the two industries, the brandname companies and the Generic Companies, are not as separated as you might think. We have seen brandname Companies BuyingGeneric Companies or launching generic subsidiaries, and moving their manufacturing to india and china as well. They will talk about quality safeguards but, in fact, there are numerous instances which a document in the book in which handle idea whats going on in their plants. They think they know and, in fact, they dont. The u. S. Has seen its manufacturing of essential medicines steilyroding. At this point in time we make te of her own penicillin. Al of that manufacturing takes place overseas. If you go fill a prescription for antibiotics f your child, the odds are that is going to come from overseas. What we have seen is this erosion of the manufacturing of esseial medicines in this country. There have been pple have been warning for years that this is a National Security risk. We are dependent o other countries. We dont control our own flow of essential medicines and as one source told me, without drugs or drug ingredients from overseas, not a single pl or tablet could be made inhis country. If we fastforward now to this crisis were in with the coronarus, this is really come home to roost, because as every country struggles to contain this virus and to maintain a suly of essential medicines, you know, we are no sort of double e dependent and experiencing drug shortages which is led to these obvious understandings that we need to make her own drugs in this country. This is not impossible. Its very possible to do, but not without a huge political will to restore manufacturing to this country. I will also say that its hard for us to imagine a time when we dit have the fda, right . The regulation of the f is what allows anyf us to go to a pharmacy and think about the medicine we get. Assume that it will be safe and effective because its required by regulations to be safe and effective. Every dose is required by regulation to be identical to another dose in the bottle. And that is a governed by an elaborate ahitecture of regulation of both current good manufacturing practices. These are very detaile regulations. But the only thing that stands betwee us and pharmaceutical disaster is the ethics of manufacturing companies, which is often dubious, and effective regulation by the fda, which is often inadequate. This is something that i think its important for readers to understand what isoverning the safety of the pill they are swallowing, and judging fromhe reviews of the book, that is something that bottle ofies will make you stop and think about. As an invesgative journalist, i have lg ft compelled to find out the truth. It might be a sort of personality trait. I hate being lied to. I alws want to figure out st of what is behind the curtain. I hate an answer questions. In 2008 when the radio show host aske me what is wrong with the drugs, i felt i had to figure th out, and it took me ten years to dohat, in which time i traveled to india, china, africa, europe, mexico, across the u. S. Never could have imagine that what sounded like a relatively simple questio would lead me on this kind of quest. A nber of times i felt like quitting but on the other hand, i i sort of knewf i didnt continue, not only was i not going to be able to answer the question of t question might not actually get answered. It felt like a giant puzzle, and i was trying to put these pieces together. I think that i would like to think tt investigative journalists deserve an essential function in a democracy, Holding Power to accou, and trying to get crucial information to the public. So i feel that its that kind of mission that drove me to complete bottle o lies, even though i do want to give up at various times. So the resulting book is a mosaic of those puzzle pieces, driven by characters and heroes who felt as compelled as i did to seek the truth. I think theres a kd of satisfaction to the reading experience of getting to that truth, and also i guess for me a satisfactionn knowing that ive been able to assemble it. And i just tnk that kind of journalism plays an Important Role may be now more than ever. Its been just wonderful to be able to participate in a literary fesval like this one, to be able to reach readers who areurious and want answers. And i hope everyone out there stays healthy and well. Tonight on the communicators we take a look at issues indepdent phone, broadband a video providers face with matt polka, president an ceo of aca connects, and boycom vision president patricia jo boyers. Our members have done such a great job of serving their communities and beatings indeed and keeping americans connected with so some of our member steg up to adopt the fccs pledge to keep americans connected. But by the same token we have also recognize that are still continuing needs, needs to serve students, needs to work with schools, needs, i need to work with hospitals and medical facilities so we can improve telehealth, ways we can increase the Broadband Network speeds, ways that we can serve unserved areas. Watch the communicators tonight at eight eastern on cspan2. Tonight former president barack obama on his new memoir a Promised Land reflecting on his life and political career. Hes interviewed by Washington Post columnist Michele Norris and Mellon Foundation president elizabeth alexander. Former president barack obama tonight at eight 8 30 p. M. On. You are watching booktv on wn cspan2, every weekend with the latest nonfiction books and authors. Cspan2 created by americas cabletelevision companies as a Public Service and brought to you tod by your television provider. With joe biden is it like, stay with cspan for live coverage of the election process and transition of power. Cspan, your unfiltered view of politics. Hello, everyone. I name is peggy clark and ive the codirector of Aspen Ideas Health and executive director of Aspen Global Innovators Group at the aspen institute. I want to thank you all for joining us today for what will be a fascinating conversation. And while the pandemic has prevented us from