Her articles on gun trafficking and coercive interrogation by the cia has 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 in her second book was published by eecho Harper Collins and is a New York Times bestseller. Based on a decade of reporting the bug takes readers deep into the overseas manufacturing plans for the majority of the lowcost generic medicine revealing if god and educated at the university of oxford where she was a rhodes scholar, she lives in brooklyn with her husband, two daughters and newfoundland dog, romeo. Doctor marty is a surgeon and professor at Johns Hopkins university and author of the New York Times bestseller unaccountable and influential voice for physicians in the wall street journal and usa today. He was the lead author of the article introducing a surgical checklist adapted by the World Health Organization published on healthcare costs vulnerable populations in a quality science. He served in the leadership of the World Health Organization surgery saves lives project and has been elected to the academy of medicine. He lives in the washington, d. C. Area and i think theres a tv series based on some of his writings. So, for everyone here we are going to ask about the end of it will be 25 to 30 minutes then we will take questions the last ten to 15 minutes then in the first tent over the books are for sale and in the second tend to b ther will be a book signing immediately following at 11 45. Good morning and thank you for joining us. I was so fascinated in reading about the story of the generic drug industry you highlight the challenges with the pharmaceuticals. Can you tell us a little bit about what it was like learning about the challenges that they had with oversized frog and a little bit about how you learned about it and if you have any fear in telling a story that was challenging and may be dangerous . Its great to be here. Thank you for the terrific questions. So, bottle of lies is a corporate crime story and takes readers deep into the overseas plans that make our mostly generic medicine. So, the project began in 2008 when i was contacted by a radio show host who had an npr Radio Program the peoples pharmacy. He said all these patients are contacting me complaining about their drugs either strange side effects or lack of affect. He was concerned if hed taken those complaints to the fda and their response was it might be psychosomatic because of the patientif thepatients are change generic to another or from a brand to generic and cfl a different color or size they may have a reaction. But, the radio show host didnt buy into that and he posed the question to me what is wrong with the drugs. And that question launched me on a decadelong reporting odyssey. Though i started with the patients and the doctors, by reporting led me to other continents. It led me to india, china, africa, as i began to probe what was happening in the distant manufacturing plants making the drugs. And what i learned is that there is endemic fraud. Often highly concealed and difficult to discern that many are seeking quality data or altering that theyve been submitted to regulators in order to get approval to market their drugs. One of the questions is what does this mean for all of us and what it essentially means for american patients around the world we may be getting drugs that are not bioequivalent that might contain toxic in. He is a flake metallic fragments or particles. But in essence, as i said the book is a corporate crime story because im exposing through internal documents, emails and stories of executives in these Companies Tha the profit motivet they had to alter the data indicate their drugs on the market. And as far as fear, yes i definitely had feared throughout this project. You know, i really when i began realizing that my reporting was going to take me to india and china, i had this moment of, not moment of the years of how am i going to do that . How am i coming as this journalist going to figure out what is going on in the countries where ive never reported, where i dont have any sources, and thats probably why the book ended up taking me ten years. I did on the ground reporting, cultivated sources come interviewed whistleblowers coming of internal documentation, and ultimately the book is based on 20,000 internal documents from the fda that i got through the source comes with it is the story of internal deliberations, emails and all kinds of regular grade assertions that rarely gets publicly exposed. Thank you. Commissioner of the fda has done a great job at escalating the generic drug approvals and you talk in your book quite a bit about the generic drug approval process and the accelerated drug application. I was surprised to learn from the book about the decrease in necessary requirements that can lead to changes in the distribution of the drug over time that had led to challenges for example with wellbutrin when it was made generically. Can you talk a little bit about the danger as you do in your book of some of the challenges in distributing aid drug over a shorter period of time and then do you have suggestions of the way the fda could move from its limited oversight on the status quo . Thats a great question with a lot of charts, but let me try to address it first by talking about the profit motives and then regulatory systems. So, when there was the wall that passed in 1984 which basically gave the generic drug industry its start, one of the questions the industry had was while, if i am going to go ahead and manufacture a generic, and i dont know if it is going to get approved, and im going to sue the brandname company and thats going to be expensive, where is the deal sweetener . So there was a deal sweetener called first to file. Basically it said at the first generic drug company that gets through the door of the fda within application and gets approved gets six months of exclusivity on the u. S. Market without competitors. So just to give you a sense of how big that is, the Indian Company got a first to file on generic lipitor in 2 24 hours it made 100 million. Over six months it was worth 600 million. So, in the generic drug industry that is the difference between making a fortune and making a living. Because they wanted to be first, as i discovered, there were literally ten cities that sprouted in the fda parking lot and Companies That would bring their executives and stretch limos overnight where they would take turns sleeping and waiting in line all to be first through the door of the fda. When the line would form there were sometimes fistfights where one company would push another companys executives out of the way because you had to be first through 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. Plans to inspect, they show up unannounced, which you assume would be the gold standard. 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 inspections sometimes two months in advance. They will contact the plants, say will you please invite us, we would like to come. And whiland will you arrange grd 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 planned by documents, they invented Standard Operating Procedures which they are supposed to have independent steam the documents overnight in a room in a kind of sauna to make them look old in the fda shows up. So the level of centrifuge that i describe in the book is remarkable. In answer to your question how do we fix this, clearly the fda needs to not tell these Companies That they are coming and if that is complicated and difficult as the companies on overseas, we should be saying to the foreign government, you want entry into our market, this is going to be the requirement, this is the standard we are going to show up unannounced. At the moment what we have, which is really pretty shocking is an honorbased regulatory system. It might surprise some people in the audience to know the fda isnt even systematically testing our drugs. What they are doing is looking at the data that the companies submit in order to determine whether they are going to approve into tha and then they e preannounced inspections to make sure that they are okay. I will say one more thing which is the fda did do a limited experiment in india they called it a Pilot Program where for a year and a half they showed up unannounced. No advanced notice, only short notice or no notice. Notice. What they discovered was incredible. Once they got rid of that advanced notice, they were finding snake and lizard infestations, pigeon droppings all over the place, bathrooms with no drainage piping and sterile sanitary areas. You can just figure out the rest of it yourself. And so, these are the kind of conditions that have a direct impact on the quality and stability of the drug. Thank you, catherine. We are going to come back to that honorbased system in a moment. Im going to give it over to doctor macquarie and talk about his book. I have to say as a doctor, i found it really troubling and reading your first chapter, reading about some of the perverse incentives as some of the unwarranted variations that you see in care. Can you tell everyone about that because i was surprised by some of the things you characterized and i think that is eyeopening for folks. Thank you, and its great to be here in the great to hear from catherine. I hope those medications are not the ones i am prescribing. [laughter] you might be. What a system. And its great to be here in texas. I love austin so thank you for having me. I think the stories that we need to talk about that no one is talking about or the areas of healthcare where there is broad consensus among the American People. So, if we can turn off cable news for a little bit and stop listening to the eco chambers that were a divided country on health care, i would set it there is a broad consensus that we need to fix the problems katherine just described. We need to end the corruption, we need to stop the disproportionate representation of a small select group of special interests. When there is a pothole in a town isnt a blue or red issued as a competency issue and in healthcare the areas of broad consensus or pricing and the appropriateness of care. Our Research Shows we are doing way too much. We asked doctors around the country what percentage of medical care in your observations including the observations of your own practice are unnecessary, and they replied the average answer 21 , 25 of diagnostic testing, 22 of medications, 11 of medical procedures. I was at a conference that does Spine Surgery and they were telling me they believe that half of all spinal surgeries or back pain in the United States is unnecessary. I dont know. Im not a spinal surgeon, but if they are correct, we have a serious crisis of appropriateness. After all is in the just one manifestation of the crisis with one medication there are many other medications we have overprescribed. Also sometimes with good intentions and bad science. But i chose to open the book with a story that local cardiologist told me of doctors going to the local churches to recruit patients for a stint in their legs to open up plaques of the leg arteries or narrowing of the artery or it turns out theres very little science to support a lot of it and people often times have no symptoms and yet they are being screened in churches. This is predominant in africanamerican churches in the auspices of healthcare. And providing Free Health Screening by these local groups and really what they were doing is they were recruiting for unnecessary procedures. I told that story ended my sites have to tell positive stories. I was privileged to tell the stories with so many disruptors and health care it was exciting for me to want to travel, to meet these folks and to present a solution with every problem. But with this problem i wanted people to realize that the beginning throwing more money into the system doesnt fix it. We already spend enough money to give everybody within our borders great healthcare we just need to cut the waste. In the politicianand the politie talking about different ways to finance the broken healthcare system, not to fix it and we need to get rid of these issues of the pricing failures and appropriateness of care. If the airlines go us after the flight and didnt show prices, they would be price gouging. You take a direct flight to chicago and you might get a bill for 4,000 they would argue we cant give you a price. We dont know if theres going to be a delay. The pilots may have to bill for turbulence, work harder and more complex medical coding after they land. You might get a surprise bill for 500 for consuming a beverage. We would say look, we can get our act together and price their services so we have a healthy competitive marketplace that would end this horrible practice of price gouging in healthcare today which i am concerned is now eroding the great public trust in our profession. Thank you. I feel like as a doctor your story resonated with me. 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 were to question their physicians, it would be hard for them to have a path that was better for their health. Can you talk a little bit about the cardiology story which is one that was interesting to me and i will say there are probably documented challenges of the insurer probably everywhere where patients may get unnecessary cardiac stents when they may not require that sometimes 20 or more. Can you talk a little bit 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 . We are not going to have the government fix healthcare. We, the American People are going to fix it by demanding more honesty. And the doctors and hospitals have a history of being honest and delivering honesty to patients. If we understand that 20 of Second Opinions are different from the first opinion some studies suggest it may be as high as 30 to 40 , you should get a Second Opinion when you are told to need something major. Now look, if you have a gunshot wound to the chest and we need to do an emergency, just to do what we tol tell you. [laughter] dont get a Second Opinion and we will never get a price in those situations. We just need to take care of you with 60 if you are told you might need an open heart surgery or you might need a stand or a spine procedure or to start this new medication every day for the rest of your life, those are opportunities to educate yourself and get a Second Opinion. We dont want to create hysteria that people should know there is a wide variation in quality in healthcare. Even within the same hospital sometimes. And so, i like to push the field. I think we need to do that in healthcare. I think sometimes we become a medical establishment where we become content in the status quo are giving that it is not as good of a system that 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 reporting for the infection rates in every admission rates and basic quality measures, i was told this was crazy and radical we could never do it and hospitals simply cant do it. I promoted this in the unaccountable. A few years later it became standard and nobody questioned it. When we suggested in a study of medical care gone wrong if it were a disease just the third leading cause in the United States, we were criticized. Within six months, the story started to come out of children dying in their car because their parents was on the opioids, and opioids within a year became the number one cause of death in people under 50 in the United States. Simply one manifestation of medical care gone wrong. And in the case of the opening chapters of the book of doctors putting stints in legs and arteries, we found that the United States Preventive Services task force condemns any peripheral vascular screening. So, when people are told that you have leg pain, we want to take a look that they should be aware this is one of those patterns where we doctors are concerned about overuse within our profession. And i will say as many examples as you give him a book on the need for back surgery and undergoing vast prayer to physical therapy or cardiac stents or leg stints for painful legs as you mentioned, all of those are just some examples of things that i think will allow patients to be better consumers of their care and we all need to be asking more questions and to try when it is reasonable to take less invasive ways to improve. Katherine, back to norfolk and revisiting the issue of depending upon honest accountability, i see that one, the generic drug industry has grown tremendously. Probably there isnt a person in this room that is not on a generic drug and a drug manufactured in a different country. You talk about many of the challenges in outsourcing to a degree because it is hard to hold individuals accountable if they may only eat one meal a day and the cultural norms and expectations about quality work products are so different than they are here in the United States. Can you talk a little bit about what some of those challenges are and if you think there is a way that we can continue to explore drug manufacturing in a safeway. As i was reporting in the book one thing i heard about with the issue of culture and how Corporate Culture impacts behavior in manufacturing plants and country culture can also impact conduct in manufacturing plants one of the difficulties is we now get just as an example, 40 of our finished generics come from india. A lot of them are just in the hinterlands of india where companies are actually employing for example illiterate farmers to do sterile manufacturing as technicians. These are people who dont have training. There is a very strong system in india there isnt a sort of habit and practice of telling the boss know that there is also much weaker whistleblower protections. I should say some of the heroes in the book. If you are going to be a whistleblower in india you have no legal protection. It may be in fact just a death sentence to complain and you also dont have a competent regulator to complain to. We have outsourced and are relying on Manufacturing Systems that are culturally quite different than they are in the u. S. And that is not to say there is no fraud in the u. S. Land. That isnt true. Its also not to say there is no fraud in the brandname manufacturing. It also isnt true but if you look at the system, one investigator said tuesday when i started investigating these brands, my question is how did anybody in the country ever think that this system was going to work . You have essentially defunct regulators in india that are more in the service of industry. They rarely show up and youve got these companies where in order to sign documents they are putting charts up on the wall to show the workers but to write down. Thats whats going on in these plans. By and large it is a system that seems absolutely designed to fail. I also just wanted to say briefly in terms of what marty was saying about what consumers understand or know about the systems, it is critical that consumers get educated about what is actually going on. As one fda consultant told me if you have a consumer that goes out to buy cheddar cheese, they understand there is a quality difference between velveeta, craft or art seasonal chador. What they dont understand is every single time they go to the pharmacy, there is a quality choice embedded in the kind of prescription drugs they take. And who the manufacturer is makes a difference as far as the quality of the drug. They are not necessarily all interchangeable as the fda has promised us. So fascinating. Can you tell us the one glimmer of hope . There are actually several, but the big glimmer of hope i have been reading your book was the promise of Quality Control. Youve obviously been a pioneer to make sure they can diminish some of the unanticipated errors. Can you talk about the role of Quality Control and do you think that there is a role for that to be publicly transparent . I think quality science is a very complex science and if it is done in a poor or mediocre way it can be counterproductive to creates perverse incentives. Ive been an advocate for the practice measurement lets get off the backs of the doctors that are trying to practice and to tailor treatments to their patients after all, medicine is an art and treatments should be customized to the goals into specific situations. Lets get rid of these barriers with all the time the pier authorizations that dont make sense that all of estonia drive burnout. Lets look at patterns. Lets look at the surgeons for example who operate on back pain when none of their patients in the entire practice over the course of the year have seen a physical therapist within a year preceding the back surgery. These are patterns in big data that are measurable that are there that our Research Team has access to. Weve punished many of them in your own field of breast care, one of them doctors offer is a breast reinsertion rate after initial blood back to me. You are calling ten to 20 of your patients back saying we didnt get all the cancer we need to take another surgical incision, that is the normal rate at which an unprotected area of cancer can be seen under the specimen. But if you are at 50 or 60 , doctors and other specialty say there is no way to justify it is too high. So we have gone around to different groups in the country practicing. Those in the rural and small hospitals and those that are leaders in the Academic Centers asking them for a pattern we can measure in big data they are telling us. They parse it out into todays been it should be done in one day routinely on hundred of the time that is a pattern where they are practicing in a way that is egregious. Sometimes it needs to be done in that way. If we can gold card to doctors when they are in the normal boundaries of the variation, get off their backs and let them Practice Medicine. Let us Practice Medicine and spend those resources helping the outliers as we did in a project. One or two if the average if they build per block. When we know our players know, they reduce the pattern of overuse and it immediately as doctor report cards. It was civility and reminding people why they went into medicine. The project is saved medicare play 7 million if we see massive improvements when we can look at patterns and to share the data with doctors letting them know you are outside of what is considered reasonable. Can we help you if we are doing it for opioid prescribing, doctors still out there prescribing 30 opioid pills after a routine procedure. You should be getting ibuprofen and acetaminophen with a local anesthetic. We are starting to measure with incredible results if that is one of the stories that i was privileged to tell in the book. We are going to move now to your questions. There is a microphone up here in front and also in the back. As we have folks but into the microphone i will just say for every consumer even though you know who did it already, there are various stories and the price we pay as you like my parents need to read this, everyone engaging in Health Care Needs to read this. We have a question up front. Speaking about being in charge of a hospital in denver she changed how they manage and what did the procedure cost. Some of the methods toyota uses when they build quality cars so the question how do we incentivize hospitals and doctors to think about how they are running the operation to keep the cost down without hurting the quality. Bureaus around the country are demanding basic services for the elected services you need to demand a price and here is a little secret from the industry. Before, during and after the care and if you dont like your bill go to your doctor we need to be engaged because we found out that their patients had been gouged and to have their paycheck garnished the hospital that sued 25,000 people in the town of 28,000 by the census data that i describe in the book after book im proud of a stop to all lawsuits. Incredible. 50 of americans had less than 400 of cash in savings. A very good. Very good. Appreciate it. It does seem to be the general discussion is putting a lot of the oldest of the consumer. The limited role for the government if we keep this more or less than the capitalist Free Enterprise it is an example of where this will go in helping us to straighten this all out. In the case of substandard generic or pharmaceutical the role for the government is very clear which is to improve its regulatory system. When consumers have more information you know where your groceries come from and where your clothing is made if we were to create transparency that could really have a market effect because of the consumers started saying i would rather take a drug that is manufactured in the usa, i think you might see some sort of shift in the return to manufacturing here at home. [applause] now people are getting hit with those prices can look at the prices and all sorts of ways now where we are starting to see the revolution for the honest prices. I would love to see more Price Transparency across the board. You talk about the negligence of the practices that go into manufacturing is what is the sophistication for million in the manufacturers in terms of chemical, molecular analysis of the actual pill can you detect the outcomes of these negligent practices it would seem it is a process that should be of keen importance seeing what the outcomes are before they are administered it is what is happening in a system where there is no routine testing. It wasnt as required investigating its own drugs. He was making Blood Pressure medicine so they recommended to the fda this should be a serious sanction on this plant. Back in maryland they said it doesnt seem that serious we downgraded the recommendation and it turns out the plant was producing active ingredients for Blood Pressure medication that they carcinogen. They said its not such a big deal. They were not routinely testing the drug, and here we are with millions of americans having Blood Pressure medication thats been recalled. So, you can do routine systematic testing for carcinogens for impurities. Its not simple or cheap but we should demand that because the system looking at the data on paper is inadequate and there are millions of americans have ended up taking Blood Pressure medication for years that contains this carcinogen. This will be our last question. [inaudible] can you speak about little bit, its hard to hear you. Are canadian drugs imported as american drugs or canadian drugs being imported in the same way. Theres a couple of issues with canadian drugs. You know, one option, politicians who are desperate to announce that they have lower drug prices are always turning to the solution of importation that if we just sort of go outside of the fda system and import from a country that has lower drug prices, that will solve all of our problems so importation is an issue that is on the table in a big way right now. I have some concerns about that. Once you go outside of the system you are inviting a lot of risk and i think that canadian drugs have taken on this notion. Often for American Consumers if you are going online probably somewhere in the fine print that is going to say if we dont have and to have the drug in stock, you are authorizing us to purchase the drug from our offshore partners. And they will just tell you this, you never want a drug from an offshore partner. Im going to ask one more question if you talk about the limitations and the challenges that we have a we all just need a nudge to improve and we want to be better looking and smarter than average. Where do you see transparency going. Do you see the efforts to become more transparent so that consumers can make better apples to apples comparisons or how do you get there . It has to be used for anything with public reporting. I actually powered by pretty closely. Price transparency ushers and quality transparency. If there is one tv for 500 in your town your question as to why buy it or not and if theres two tds on for 501 for 600 what do you say i want to know all of the specs and details and longterm outcomes so Price Transparency and quality transparency there are these new clinics sprouting up all across the country growing like wildfire and the doctors now rejecting the bill in the throughput model of care that we hate and patients hate and spending time with folks and using the team and talking about food as medicine into treating diabetes with cooking classes and managing back pain with ice and physical therapy instead of just the surgery and opioids, these clinics are growing all over america and take the form of direct primary care, Medicare Advantage plans. They are revolutionizing healthcare and bringing in bags of medication because they dont need them anymore once we address these underlying issues that drive our crazy crisis. [applause] if you need to pick up a book on the way in the first ten to thank you. There is a long history of politics to get content into the classrooms and its come both from the left and the right. More from the right is a great. We have the common core standards which a lot or voluntary states can choose whether or not to adopt them in 46 states at one point have adopted them some of the album debate could then have something similar and a lot of people think that is a curriculum that the standards are curriculum and have content and that is what some of the opposition is premised on. They mention a few foundational histories but there is in the literacy standard no specification of content. They read like a list of skills. Out of the supplementary materials to the standard if you want students to be able to meet these standards you have to build their knowledge through a coherent curriculum that exposes them to topics and history many people are not aware of that language being there and even those that are may have difficulty sort of responding to it because they may be caught in a system that isnt set up to respond to it but we got that standard that lacks content because of previous battles which i talk about in the book over content and some of which have gotten to be like a media circus about the National History standards for example so everybody has shied away from specifying content. But if you dont specify content, you get this focus on skills because people look at the standards and think thats all i need to do. I do think that there are ways to avoid these political battles and there are an increasing number of districts in the classrooms through the country that are adopting fairly newly developed content which in the curriculum there are six or seven of them out there now and some of them have a social justice orientation and some have a more western culture orientation. I havent heard a lot about political battles over the supplementary curriculum. I think to some extent it is a red herring and the controversies i have heard about have been raised about models that are already being taught in a lot of Elementary Schools had me touch on something some parents are not wild about, but i think the bottom line is we cannot let our fear of political battles prevent us from giving the kids who need access to knowledge than most and they cannot prevent us from that access. To watch the rest of the Program Visit the website booktv. Org and click on the after words tab at the top of the page. [inaudible conversations] good evening. If i could ask the last of the guests to take their seats. I want to welcome everyone. Im the director of programming and engagement at the museum of heritage a living memorial to the holocaust. A little bit about this institution before we go into the program. This is the Third Largest Holocaust Museum in the world offering a range of rigorous and engaging exhibitions, programs and resources. In the world of rising intolerance, antisemitism and holocaust denials we are
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