On cspan2. Great weather here all the time. [inaudible conversations] good morning. Welcome to the texas book festival. Im joined today by two incredible authors who are going to help us unpack American Health care. Katherine eban, who whens an investigative journalist, a Fortune Magazine contributor and an Andrew Carnegie fellow. Her articles on pharmaceutical counterfeiting, gun trafficking and coercive interrogations by the cia have Won International attention and numerous awards. She lectures frequently on the topic of pharmaceutical integrity, bottle of lies the inside story of the generic drug boom, her second book, was published bihar per collins in by harpercollins in may. Based on a decade of reporting, the book takes readers into manufacturing plants where the majority of our low cost generic medicine is made. Educated at Brown University and oxford where she was a rhodes scholar, eban lives in brooklyn with her husband, two daughters and newfoundland dog romeo. Dr. Marty makary works at Johns Hopkins university and author of the New York Times bestseller unaccountable an influential voice for physicians. He was the lead author of the articles introducing a surgical checklist adopted by the World Health Organization and has publishedded successfully on health care costs, vulnerable populations and quality science. He served in leadership at the World Health Organizations safe surgery saves lives project and has been elected to the National Academy of medicine. He lives here he lives in the washington, d. C. Area, and i think theres a tv series based on some of his writing. So for everyone here, were going to ask them some about their book. Thats going to be about 2530 minutes, then well take questions. So the last 015 minutes. 1015 minutes. Then in the first tent over, the books are for sale, and in the second tent over, therell be a book signing immediately following this at 11 45. So good morning, thank you for joining us. I was so fascinated, katherine, in reading about the story of the generic drug industry as you highlight the challenges with pharmaceuticals. Can you tell us a little bit about what it was like learning about the challenges that they have there with oversight, fraud, and a little bit about how you learned about it and if you had any fear in telling the story that was challenging and maybe dangerous . Well, its great to be here and thank you, deborah, for those terrific questions. So bottle of lies a corporate crime story. And it takes readers deep into the overseas plants that make our low cost, mostly generic medicine. The project began in 2008 when i was contacted, actually, by a radio show host who has an npr radio program, the peoples farm i. He said pharmacy. He said all these patients are contacting me complaining about their generic drugs, either strange side effects or lack of effects. He was concerned, and he had taken those complaints to the fda, and their response was, well, it must be psychosomatic because if patients are changed from either one generic to another or from a brand to generic and they see a pill thats a different color or size, they may have a reaction. But joe graden, whos the radio show host, did not buy that, and he posted questions he posed a question to me, what is wrong with the drugs . And that question launched me on a decadelong reporting odyssey. And though i started with the patients and the doctors, my reporting led me to other continents. It led me to india, to china, to africa as i began to probe what was happening in the distant manufacturing plants that are making our drugs. And what i learned is that there is endemick fraud in these endemic fraud in these plants. Often highly concealed and difficult to discern, but many of these plants are faking quality data that or altering data that they then submit to regulators in order to get a approval to market their drugs. So, you know, one of the central questions is what does this mean for all of us, and what it really means for american patients and others around the world is that we may be getting drugs that are not actually bioequivalent, that might contain toxic impurities, metallic fragments or particles. But in essence, as i said, the book is really a corporate crime story because im exposing through internal documents, emails and the stories of executives in these companies the profit motive that they have to alter this data and get their drugs on the market. And as far as fear, yes, i definitely had [laughter] fear throughout this project. You know, i really, when i began realizing that my reporting was going to take me to india and china, i just had this moment of not moment, maybe years how am i going to do. That how am i, as a solo journalist, going to figure out what is going on in these countries where aye never reported where ive never reported, where i dont have any sources. Of and thats probably why the book ended up taking me ten years. I mean, i did on the ground reporting, cultivated sources, interviewed whistleblowers, got internal documentation and, ultimately, the book is based on 20,000 internal documents from the fda that i got through a source. So that is the story of interim deliberations, emails internal deliberations, emails and all kinds of regulatory decisions that rarely get publicly exe posed. Thank you. So, commissioner gottlieb of the fda has done a great job at escalating generic drug approvals. And you talk in your book quite a bit about the generic drug approval process and the accelerates new drug application accelerated new drug application. I was surprised to learn in the book about the decrease in necessary requirements that can lead to changes in directs of a drug changes in distribution of a drug over time. For example, with well buy flynn when it was well buy flynn when it was made generically. Can you talk about the dangers as you do in your book about some of the challenges in distributing a drug over a shorter period of time, and then do you have suggestions of the way the fda could move from its limited oversight to something more to correct upon the status quo . So let me, thats a great question with a lot of parts, but let me try to address it by talking about, first, profit motives and then regulatory systems. So when there was a law called hatchwaxman which passed in 984 which basically gave the generic truck industry its start the drug industry its start. One of the questions the drug industry had was, well, if im going to go ahead and manufacture a generic and i dont know if its going to get approved and im going to have to sue the Brand Name Company and thats going to be expensive, wheres the deal sweetener . So there is a deal sweetener that was put into hatchwaxman called first to file. Basically said the firstier generic drug company that gets through the door of the fda with its application and gets approved gets six months of exclusivity on the u. S. Market without competitors. So just to give you a especially of how big that is a sensing of how big that is, an Indian Company got a first to file on generic lipitor. In 24 hours it made 100 million. Over six months it was worth 600 million. So in the generic drug industry, it is a the difference between making a fortune and making a living. Because they wanted to be first, as i discovered, there were literally tent cities that sprouted in the fda parking lot, and companies that would bring their executives in in stretch limos oversight where they would take turns sleeping and waiting on line all to be first through the door of the fda. And when a line would form, there were sometimes fistfights where one company would push another Company Executive out of the way because you had to be first in the door and put your application down. So the profit motive is intense. So thats number one. Then theres the problem of regulation. When the fda sends its investigators into u. S. Plants to inspect, they show up unannounced which you would assume would be the gold standard, right . You dont tell them youre coming, you just show up. But overseas, because it is difficult and complicated, they have a very different system. They will announce their inspection sometimes two months in advance. They will contact these plants and say will you please invite us, wed like to come, and will you arrange Ground Transportation and hotel accommodations. So the investigators show up as invited guests of these companies which then literally have two months to alter, fabricate documents. In one plant that i document, they invented Standard Operating Procedures which theyre supposed to have and then steamed the documents overnight in a room, in a kind of saunalike room to make them look old for when the fda showed up. So the level of subterfuge which i describe in the book is really remarkable. So in answer to your question how do we fix this goat rodeo, clearly the fda needs to not tell these companies that theyre coming. And if that is complicated and difficult because the companies are overseas, we should be saying to foreign governments, you know what . You want entry into our market, this is going to be the requirement. This will be the standard. Which is, were going to show up unannounced. So at the moment what we have, which is really pretty shocking, is an hornbased honorbased regulatory system. It might surprise some people in the audience to know that the fda is not even systematically testing our drugs. What theyre doing is theyre looking at data that the Company Submits in order to determine whether theyre going to approve, and then the they do these preannounced inspections to make sure the plants are okay. I will say one more thing which is the fda did do a limited experiment in india where they called it a Pilot Program where for a year and a half they showed up unannounced. No advance notice, only short notice or no notice. What they discovered was incredible. Once they got rid of that advance notice, they were finding snake and lizard infestations, pigeon droppings all over the place, bathrooms with no drainage piping inner the apriling sanitary areas in sterile, sanitary areas so you can just figure out the rest of it yourself. [laughter] and so these are the kinds of conditions that have a direct impact on the quality and sterility of the drug, and they have to be exposed. Thank you, katherine. And were going to come back to that honorbased system in a moment. Im going to pivot to marty, dr. Makary now, and talk a little bit about his book. I have to say as a doctor, i found it really troubling in reading your first chapter, i had chest pain reading about some of the perverse incentives and some of the unwarranted variation that you see in care. Can you tell everyone about that . Because i was surprised by some of the things that you characterized, and i think thats kauaiopening for folks eyeopening for folks. Well, thank you, dr. Pratt, and its great to be here and great to learn from katherine here too, and i hope those medications are not the ones im prescribing. [laughter] well, you might be. Probably. Great. What a system. [laughter] and its great to be here in texas. I love austining, so thanks for having me. You know, i think the stories that we need to talk about that no one talking about are the areas in health care where theres broad consensus among the american people. So if we can turn off cable news for a little bit and stop listening to the echo chambers that were a dividedded cup on Health Care Country on health care, i would submit to you that theres broad consensus that we need to fix the problems that katherine just describedded, that we need to end corruption, that we need to stop the disproportionate representation of a small, select group of special interests. When theres a pothole in a town, its not a blue reddish shoe, its a we e ten city issue. And in health care, the areas where i think there is broad consensus are pricing and the appropriateness of care. And our Research Shows that were doing way too much. We asked doctors around the country what prosecute of what percent of medical care in your observations, excluding the ox vegases of your own observations of your own practice, are unnecessary. And they replied an average answer of 21 . 22 of medications, unnecessary. 11 of medical procedures. I was at a conference of neurosurgeons that do Spine Surgery, and they were telling me that they believe that half of all Spine Surgery for back pain in the United States is up up is unnecessary. I dont know, im not a spine surgeon, im a pancreas surgeon. But if theyre correct, we have a serious crisis of appropriateness. After all, isnt the Opioid Epidemic just one manifestation of that crisis with one medication . There are many other medications that weve overprescribed also sometimes with good intentions and bad science. But i chose to open the book with the story that a local cardiologist told me of doctors going to the local churches to recruit patients for stents in their legs to open up plaques of the leg arteries or narrowing in the leg artery. Well, it turns out that theres very little science to support a lot of it. And people often times are no symptoms have no symptoms, and yet theyre being screened in churches. This was predominant in the enter under the auspices of a health fair in the auspices of providing free health screamings by these local groups screenings. And what they were doing was they were recruiting for unnecessary procedures. So i told that story, and i find with health care weve got to tell positive stories. And i was privileged to tell the stories. I have so many disrupters in health care, it was exciting for me to learn, to travel to meet these folks and to present a solution with every problem. But with this problem, i wanted people to realize at the beginning that throwing more money into the system does not fix it. We already spend enough money to give everybody within our borders great health care. We just need to cut the waste. And the politicians really are talking about different ways to finance the broken health care system, not how to fix the broken health care system. And if you fix it, we have to get at these issues of pricing failures and the appropriateness of care. You know, if airlines billed us after the flight and didnt show prices [laughter] they would be price gouging. You take a direct flight to chicago and you might get e a bill for 4,000. And they would argue we cant give you a price, we dont know if theres going to be a delay, or the pilot may have to bill for turbulence and work harder and more complex medical coding after they land. And you might get a surprise bill for 500 for consuming a beverage. [laughter] we would say, look, we can get our act together, as the Airline Industry has, and Price Services so we have a healthy, competitive marketplace that would end this horrible practice of price gouging in health care today which im concerned is now eroding the great public trust in our great profession. Thank you. I felt like as a doctor your story really resonated with me. We do a lot of work in valuebased care, but i felt like most importantly the consumers need to read this book because without opening their eyes to some of the ways in which there can be perverse incentives or to question their physicians, that it would be hard for them to have a path that was better for their health. Can you talk a little bit about particularly the cardiology story was one that was interesting to me, and ill say theres publicly documented challenges of that in texas. Im sure probably everywhere. Where patients may get unnecessary cardiac stents when they may not require that, sometimes 20 or more. Can you talk a little about that story and then, as a consumer, how you can be more discriminating about what you need for health care and what you dont . Sure. It is i think were not going to have the government Fix Health Care. We, the american people, are going to Fix Health Care by demanding more honesty. And doctors and hospitals have a history of being honest and delivering honesty with patients. And if we understand that 20 of Second Opinions are different from the first opinion some studies suggest it may be as high as 3040 you should get a Second Opinion when youre told you need something major. Now, look, if you have a gunshot wound to the chest and we need to do an emergency thoracotomy, just do what we tell you [laughter] and dont get a Second Opinion. And were never going to give you a price in those spanish situations in those situations, we just need to take care of you. But when youre told, hey, you might need an open heart surgery or you might need a stent or you might need a spine procedure or a knee otter pscopy, those are opportunities to educate yourself, get a Second Opinion. We dont want to create hysteria, but people should know there is wide variation in quality in health care. Even within the same hospital sometimes. And so i like to push the field. I think we need to do that in health care. I think sometimes weve become a medical establishment where weve become content with the status quo. Arguing that its not a good system, but weve not really challenged it. I think too many of us just collect our paycheck every two weeks and complain about the system, and we really need to speak up. When i suggested we should have public informing for infection rates and basic quality measures i was told this was crazy, radical and hospitals simply cant do it. And i promoted this in the book unaccountable. Well, a few years later it became standard, and nobody when we suggested if it were a disease that was ranked as the third leading cause of death in the United States, we were criticized. Within six months the story started to come out of children dying in their car because their parent was on opioids, and opioids within a year became the number one cause of death in people under 50 in the United States. Isnt that simply one manifestation of medical care