Inside story of the generic drug boom and im talking t you today from massachutts. Im actually usuly based in brooklyn, new york, but were hunkering down in cape cod this summer. My book is a true crime expose of the generic drug industry an takes the readers deep into the distantanufacturing plants in india and china that make most of americas low cost medicines. Heavily reported over the course of 10 years, the book follows several key characters, an industry whistle blower, a fda investigator as they begin to uncover widespread fraud in these manufacturing plants. The question is, what made me want to pursue this topic . Im an investigative journalist and i have 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 had the show called the peoples pharmacy. His name is joe braden, and he called me with a tip. He said that listeners were calling into his Radio Program and complaining about their generic drugs, they were having side effects and the drug seemed ineffective. When he took those complaints to the fda, they said that the reactions were probably psychosomatic, because the drugs looked different than the other drugs and he posed a question, namely, what is wrong with the drug . And thats really where my reporting began, as an eort to answer tt question. Som people noted the book begins withandhi in ashram in india and what does that have to do with generic drugs . Well, it was world war iind the british were in india, of course. And they wer having to fight germany and there was fighting all over the world and they needed pharmaceutical supplies r their army. And at that poin the indian wanted their independence from the british so basically ty nt to the british went to gandhi and said, look, if you want independence, help us with pharmaceutical supplies for our army and we will consider giving you freedom. And so the pharmaceuticals that the indians started manufacturi manufacturing, the active ingredients that they started maki at that time grew into a giant industry i india. But it began actually with a bid for freedom. One of the main characters in the book is named danesh, hes an engineer and worked at Bristol Squibb in new jersey. He was going to india to work at indias Largest Drug Company at the time called ranbaxy and recruited him to move to india and join this company. He does, he goes and he gets a new boss who is the head of research and development. That boss begins to get worried about the quality of the data that ranbaxy is filing with regulators around the world. Because in order to get drugs approved. You have to submit quality data to regulators saying your drugs meet the standards. So his new boss, this was roughly in 2004, his new boss gives danesh assignment. Look into all of ranbaxys worldwide Regulatory Filings and find out if the data is real or fake. So, he takes his team and starts delving into this and finds ranbaxys secret. For 200 drug products in 44 countries around the world ranbaxy just invented data. Theyve just made up data in order to make substandard drugs look like they meet quality. In a very sort of dramatic series of events, daneshs 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 danesh is forced out of the company and 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 the actions surrounding this are formed for the narrative of a bottle of lies, but it might surprise people to know this, but 90 of the drug supply is generic. If you go to a pharmacy almost the prescription 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. And the majority of our finished dose generics are also coming from overseas, 40 of those drugs alone are being made in india. Now, 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 inspectors plants in the u. S. , they show up unannounced and stay as long as needed. Because of the complex logistics of overseas inspections, the fda will announce that its coming months in advance from overseas inspections. So that gives manufacturing plants the opportunity to clean up, which they do, and 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 back date documents, they will shred documents, they will sometimes even create new documents and leave them in overnight in a saunalike room to make them look old which is what i uncovered. The question is not just are they required to inspect, but what is the quality of those inspections. So right off the bat you have a very different situation. And it goes downhill from there. One. Things that i uncovered is that the industry uses a system of manufacturing that theyve called dual track production. Essentially, that amounts to adjusting the quality of the drugs depending on the market theyre shipping into. So 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 being of the drugs being sent to africa, which essentially means that people in those markets are getting completely untested and unproven medications. So 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, were very troubled and concerned about the quality of the aids drug bound for africa and she raised it on a Conference Call with company executives. The medical director of the company said, who cares . Its just and that gave her a vivid understanding of the standards and ethics of the company. You know, some people have said, oh, well, this is just an antigenerics book. Thats not the case because it has profound implications for big pharma. So the two industries, the brandnamed companies and Generic Companies are not as separated as you might think. We have seen brandname Companies Buying Generics Companies or launching generic subsidiaries and moving their manufacturing to india and china as well. You know, they will talk about quality safeguards, but, in fact, there are numerous instances, which i document in the book, in which they have no idea whats going on in their plant. You know, they think they know and, in fact, they dont. The u. S. Has seen its manufacturing of essential medicinesteadily eroding. At this point in te we make none of our own penicillin. All of that manufacturing takes place overseas. If you go fill a preription for antibiocs for your child, the odds are that its going to come from overseas. So what weve seen is this erosio of the manufacturing of essential medicine in this country. You kn, there have been pele who have been warning for years that this is a tional security risk. You know, were dependent on other countries, we dont control our own fw of essential medicines and as one told me, without drugs or drug ingredients from overseas, not a single pill or tablet could beade in this country. So if we fast forward now to this crisis that were in with the coronavirus, you know, h really come home to roost because as every country struggles with this virus and to maintain a supply of essential medicine, you know, we are n sort of dbly dependent a experiencing drug shortages which has led to the sort of obvious understanding that we need to make our own drugs in thi untry. You know, this is not impossible. Its very possible to do, but not without a huge political will to restore manufacturing to this country. You know, i will also say that its hard for us to imagine a time when we didnt have the food and drug adnistration, right . The regulation of the food and Drug Administration is what allows any of us to go to a pharmacy and not think about the medice we get, right . We assume that it will be safe andffective because its actually required by regulation to be safend effective. And every dose is required by regulation to be identical to another dose in a bottle. And thats all governed by an elaborate architecture of regulations called cgmp. Current good manufacturing practices. These are very detailed regulations. You know, but the oy thihing that stand between us and pharmaceutical disaster is the effects of manufacturing companies, which is often dubis, and effective regulation by the fda, whi is often inadequate. So you know, this is something that i think is importa for reader to understand, you know, what is governing the safety of theill that theyre swallowing . And you know, judging from the reviews of thebook, thats something that bottle of lies will make you stop and think ab about. As an investitive journalist, i have lon felt compelled t find out the truth. It might be a sort of peonality trait. I hate being lied to. I always wan to figure out sort of whats behind the curtain and i hate answered questions. So, you know,n 2008 when the radio show host joe graden asked me what is wrong with the drug, i felt i had to figure that out, and it tk me 10 years to do that, in which time i traveled to india, china, africa, europe, mexico, across the u. S. , i could never have imagined that what sounded like a relatively simple question, would lead me on this kind of quest. And you know, a number of times i felt like quitting, but on the other hand, i sort of knew that if iidnt continue, not only was i not going to be able to answer thequestion, but the question might not actually get answered. So, you know, it felt like a giant puzzle and i was trying to p these pieces together. I think that id like to think th investigative journalists do serve an essential function in a Democracy Holding power to acunt and trying to get crucial information to the public. So i feel that its that kind of mission that drove me to complete bote of liesven though i dearly wanted 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. You know, so i think that theres a kind of satisfaction to the reading experience of getting to that truth. And also, i guess, for me, a satisfaction in knowing that ive been able to assemble it and i jt think that, you know, that kind of journalism plays an important role, maybe now more than er. And so, its been just wonderful to be able to participate in a Literary Festival like this one, to be able to reacheaders who are curious and want answers, and i hope everyone out there stays healthy and well. Today, live on cspan2, a live conversation with former president barack obama and his newly published memoir, a Promised Land reflecting on his life and political career. Hes interviewed by Michelle Norris and elizabeth alexander. Former president barack obama 11 30 a. M. Eastern on book tv, cspan2. Today the Michigan Bureau of elections meets to certify the States Election results. The fourmember bipartisan board is required by law to certify the results by november 23rd. So far, all of michigans 83 counties have certified their results, but the rnc and state republican officials have asked the board to delay certification in order to audit results from wayne county and detroit. Watch live coverage of the boards meeting at 1 p. M. Eastern on cspan. Hello, everyone, my name is peggy clark and im the codirector of aspen idea health. I want to thank you for joining me for what will be a fascinating conversation. While the pandemic has
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