Im joinedho today by two incredible offers tha authors te going to help us with American Health care. Katherine eban, investigative journalist and the articles on counterfeiting have Won International attention and numerous awards. She lectures frequently on the topic of pharmaceutical integrity, the inside story of the generic drug bill and the book was published by harpercollins as a bestseller. For the majority of the lowcost of Generic Medicines made repealing fraud and dire conditions educated at Brown University in oxford where she was a Rhodes Scholar lives in brooklyn with her husband, two daughters and dog, romeo. Doctor marty makary told policy at Johns Hopkins university and author of the best seller unaccountable and influential voice for position in the wall street journal and usa today he was the lead author of the articles introducing a checklist adapted by the world health organization. Hes been elected to the academy of medicine and he lives here in washington, d. C. Area and i think there is a tv series based on some of the writing. So, for everyone here we are going to ask about the book. Its going to be about 25 to 30 minutes and then we will take questions. Then in the first ten the books are for sale and in the second there will be a book signingco immediately following at 11 45. Good morning and thank you for joining us. I was so fascinated reading about the story t of the generic drug industry as you highlight the challenges with the pharmaceuticals. Can you tell us a little bit about what it was like learning about the challenges they had with oversight, fraud and a little bit about how you learned about it and if you had any fear telling a story that was challenging and may be dangerous . Its great to be here. Thank you for those terrific questions. So, bottle of wine this is a corporate crime story and to take readers into the low cost mostly Generic Medicines. The project began in 2008 when i was contacted by a radio show host who had a progra have a pre peoples pharmacy. He said all these patients are contacting me complaining about their generic drugs. The response was that must be psychosomatic because if patients are changed from one generic to another or a brand of generic antecedent different colore or size, they may have a reaction. The radio show host didnt buy thate,. Butnc the question launched a decadelong reporting odyssey that started with the patients and the doctors. My reporting led me to other continents. India, china, africa and i began to probe what was happening in the distance manufacturing plants that are making our drugs and what i learned is there is an endemic fraud. Often highly concealed and difficult to discern but many are taking quality data that they been submitted to regulators in order to get approval to market their drugs. So, one of the questions is what of us andmean for all what this essentially means for american patients and around the world is we may be getting drugs that are not actually bioequivalence that might contain toxicha activities like metallic fragments were particles. But in essence as i said, its a corporate crime story because im exposing through internal documents, emails and stories of executives in these companies the profit motive that they had to alter a the data and get ther drugs on the market. How am i going to do that and how as a solo journalist am i going to figure out what is going on in these countries where i never reported and i dont have any sources and that is probably why the puck ended up taking me ten years. There was internal documentation and ultimately the book is based on 20,000 internal documents. From internal deliberations, emails and all kind of regulatory decisions. The commissioner of leaves of gf the fda, great job. I talk about the process and accelerated drug application. I was surprised to learn from thes book about the decrease in the necessary requirements that could lead to changes in the distribution of the drug over time. Do you have suggestions of the way the fda could move from its limited oversight with more to protect the status quo. It gave the generic drug industry is a start. Drbut one of the questions the industry had is if im going to go ahead i dont know if its going toov get approved and if i had to sue the brandname company, where is the deal sweetener. The first drug company that gets through the door at the fd fda t supplication and gets approved gets six months of exclusivity. They got a genericit drug of lipitor. Over six months to raise more than 600 million. In the generic drug industry, that was 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 sdk parking lot and companies that would bring their executives and stretch limos overnight where they would take turns. There were other executives pushed out of the way because you have to be first through the door to put the application down so the profit motive is intent. Thats number one. Then theres the problem of regulation when they send the investigators to the plans t to inspect, they show up unannounced which would assume would be the gold standard, you dont tell them youre coming, and you just show up. But overseas, because it is difficult and complicated, there is a very different system. They will amount to the inspection sometimes two months in advance. They will contact the plant and say what you please invite us, we would likel to come, and will you arrange transportation and hotel accommodations. The investigators show up and they literally have two months to alter, fabricated documents and one that i document they oinvented documents they are supposed to have independence theme of the documents overnight in a room in a kind of sauna to make them look old for when the fda shows up. So, in answer to your question, how do we fix this . The need to not tell the companies they are coming and if that is complicated and difficult because they are overseas, we should be saying to the Foreign Government you want entry into the market, this is going to be the requirement, this will be the standard which is we will show up unannounced. At the moment but we had was pretty shocking. It might surprise people in the audience to know the fda isnt even systematically testing drugs. They are looking at data but the company said its in order to determine whether they are going to improve and the then they do these announcements inspections to make sure that the plants are okay. If shows up unannounced, no advanced notice. Only short notice or no notice. Bathrooms with no drainage you can figure out the rest of it resolved. We are going to come back to that system in a moment. I have to say ass a dot or i found it troubling in reading the first chapter some of the unwarranted variation, can you tell everyone about that because i was surprised by some of the things youvete characterized. Its great to be here and to learn. I hope those medications are not the ones im prescribing. [laughter] its great to be here in texas. I think there is stories we need to talk about but no one is talking about. The areas of Health Care Workers 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 we are a divided country on health care, i would submit is a ixoad consensus that we need to fix the problems that were just described. We need to end e corruption. We need to stop the disproportionate representation of a small select group of special interests. When there is a pothole in the town its not a blue or red issue and in healthcare theres broad consensus. Research shows we are doing way too much. We have to ask what percentage of medical care in your observation excluding your own practice are v unnecessary and they replied in average answer of 21 , 25 of diagnostic testing, 22 of medications, 11 of medical procedures. I was at a conference bu but the of Spine Surgery and they were telling me that they believe half of all surgery for back pain in the United States is unnecessary. After all isnt the Opioid Epidemic just one manifestation of the crisis with one medication . There arere many others that we have overprescribed also with sometimes prevented theman sandbagged science, but i chose to opendoublequote the story a local cardiologist told me, doctors going to the local churches to recruit patients to open up the leg arteries or narrowing in the leg artery or it turns out that there is very little science to support a lot of that and people often times have no symptoms. And yet they are being screened in churches. This was predominant in africanamerican churches. The under the auspices of providing Free Health Screenings by these local groups and really what they werecr doig was they were recruiting for unnecessary procedures. I told that story and weve got to tell positive stories. I was privileged to told. I haveth so many disruptors andd health care it wasra exciting fr me to learn, travel, meet these folks and present a solution that i wanted people to realize throwing more money into the system doesnt fix it. We already spend money at the borders to get great health care, we just need to cut the waste. And politicians are talking about different ways to finance the broken Healthcare System, not put the broken Healthcare System and we have to get at these issues of pricing failures and the appropriateness of care. If they billed us after the flight and the show prices, they would be price gouging. You take a direct flight to chicago and you might get a bill for 4,000 colors and they would argue we cant get a price we dont know if theres going to be a delay with the pilots may have to go for turbulence. You might get a bill for 500 for consuming a beverage. We would say we can get our act together and Price Services and they woulit would end this horre practice of price gouging and its now bee now eroding the grt bblic trust in our profession. For the ways those have never been perverse incentives and to question their physician that it would be hard for them to have a itpath better for their health particularly the cardiology story. There is publicly documented challenges of that and im sure probably everywhere where patients made get unnecessary when they may not require that 20 or more. Mihow can you be more discriminating about what you need for health care and what you dont . We are not going to have the government fixca health care. We, the American People are going to fix healthcare by demanding more honesty and doctors at hospitals for the history of being honest and delivering. If we understand that 20 of Second Opinions are different from the first opinions of some studies suggest as high as 30 to 40 , you should get a Second Opinion when you are told you need something major. If you have a gunshot wound to the chest, just do what we tell you and dont get a Second Opinion. We will never give a price in that situation. 60 of medical care is chockfull and wee are told you might need an open heart surgery or you might need a stand or a spinal procedure to start this new medication every day for the rest of your life. Those are opportunities to educate your self. We dont want to create hysteria that people should know theress a wide variation in quality healthcare. Sometimes we become a medical establishment where we can become content with the status quo ar arguing that its not a d system. Too many of us collect a paycheck every two weeks and complain about the system and we really need to speak up. When i suggested we should have public reporting and basic quality measures. The story started to come out of children dying in their car because the parent post on opioids and within a year it became the number one cause of death in people under 50 in the United States. And thats simply one manifestation of medical care gone wrong. In the opening chapter of the book of doctors putting students in leg arteries we found that the United StatesPreventive Services task force condemned any vascular screening so when people are told they have some leg pain we want to take a look and they should be aware this is one of those patterns where we are concerned about overuse within our profession. N. They are better consumers of their care as weo all need to be asking more questions and to try when it is reasonable to improve. Back to your book on the honest accountability, i see that the generic drug industry has grown tremendously. There probably wasnt person in this room that wasnt on a generic drug manufacturer to. You talk about the challenges outsourcing to that degree because it is hard to hold individuals accountable. To talk about the quality work products they are different than they are here in the United States. Can you talk a little bit about some of those challenges are and if you think that there is a way that we can continue to export drug manufacturing in a safeway. It can also impact the conduct in manufacturing plant so one of the difficulty as an example 40 of the finished generic comes from india. So a lot of these are just in the hinterlands of india where companies are actually employing illiterate farmers to do sterile manufacturing as technicians and these are people who dont have training. There is a very strong system in india s is that there isnt a st of have it and practice telling the boss know. But there i theres more whistlr protections. So, i should say some of the heroes of this book is indian but if you are going to be a whistleblower in india, you have no legal protection. It may be a death sentence to complain about the practices and you also dont have a competent regulator to complain to. We have outsourced or are relying on systems that are culturally quite different than they are in the usa tha but thas not to say there is no fraud in the u. S. Land. If you look at the system, one investigator said to me when i started investigating these plans. You had regulators in india that see the role more as being in the Service Industry they rarely show up and youve got these companies where in order to sign documents they are putting charts on the wall to show the workers what to write down. Thats what is going on in these plans so by and large it is a system that seems absolutely designed to fail us. I also want to say briefly what consumers understand or know about the system it is critical that consumers get educated about what is actually going on. They told me if you have a consumer that goes out to buy cheddar cheese, they understand that there is a quality difference between david, craft or art hes a much better. When they go to a pharmacy, there is a quality choice embedded in the kind of prescription drugs theycr take d who the manufacturer is makes the difference as far as the quantity of the drug. They are not necessarily all interchangeable as the fda has promised us. The glimmer of hope i have is that quality control. Youve obviously been a pioneer to make sure the surgical checklist can diminish the errors that you can see. Do you ever think there is a role for that to be publicly transparent . The i think that quality science is a very complex science and if it is done in a poor or mediocre way it can be counterproductive and create perverse incentives. So, i personally have been an advocate for practice pattern measurement. That is lets get off the back of the doctors that are trying to practice and tailor the treatments to their patients. After all, medicine is an art and treatments should be customized. We deal with the peertopeer pre authorizations that dont make sense and lets look at patterns of the surgeons that operate onin back pain when none of their patients in the practice of the year have seen a physical therapist within the year preceding the back surgery. These are patterns in the dictate of that are measurable and the Research Team has access to them and we publish many of them. One of them that the rest of doctors offered is the reinsertion rate after initial lumpectomy. If you are calling ten or 20 of the o patients. We need to take another surgical excision that can be the normal rate at which it can be seen on the edge of the lumpectomy specimen. But if you are at 50 or 60 , doctors in that specialty say theres no way to justify it. That is too high, the doctor needs help. P. So we have gone around different groups in the country that are practicing not just in the ivory tower or at the universities, but thoseun on the ground in the United States in rural and small hospitals as well as those that are leaders in the Academic Centers asking them tell us about a pattern so that we can measure the data. And they are telling us. It really should be done in one day routinely 100 of the time that is the pattern where the doctors are practicing in a way that is courageous. Sometimes it needs to be done that way so if we can go kart for doctors when they are within the normal boundaries of variation, get off their backs and let us Practice Medicine and to spend those resources helping the outliers as we get into a project with most surgery for skin cancer surgery doctors to take up too many blocks were speeches per case that is removing the cancer with four or five blocks on average specimens rather than one or two, which is the average they billed perr block so an area is taking out too many. When we let our players know, a e. G. 3 reduced the pattern with confidential report cards. It is civility and reminding people why they went into medicine. And they corrected it. As is medicare 27 million wedi are seeing massive improvements when we can look at patterns and share the data these are patterns of overuse that we can measure and shut fischer and we are starting to measure withf incredible results and thats one of the stories that was privileged. We are going to move now to youyour question so there is a microphone appeared i up here id also in back. I will just say it does read like a thriller even though you knew who did it already and the competition of theug various stories and the pricece we pay s so fascinating i felt like my parents need to read this. We have a question up front. They changed how they managed the hospital and forced them to figure out what did the procedure cost and how much time should we spend and she cut the cost like 30 without any impact on care and accused some of the methods toyota uses when they billed quality into their cars so the question is how do we incentivize hospitals and doctors to think about how they are running the operation to keep the cost down without hurting quality. Or even being transparent about price. The only reason is people like you and americans and the country aree demanding prices r basic services. Before, during and after the care and if you dont like the bill, go to your doctor, dont worry about bothering us. We need to be engaged because we found when we told patients they had been gouged from services and the soothing courts sometimes to have their paycheck garnished, a waitress taking a second job because the hospital garnished her paycheck and this is going on around the country they sued 25,000 people in the town of 28,000 at the census data that iy describe in the bk after the buck i printed and im proud to report they agreed to stop the lawsuits. When i visit with these folks 50 of americans have less than 400 of cash and savings. They dont live like me. Look like me. They dont look like us. We need to remember they are threatening the Greater Public trust and we need to rebuild withd honest pricing. The next question. It seems to me that general discussion is putting the onus on the consumer. A lot ofof us are reasonably welleducated but even for the more educated, its pretty tough to navigate the way through and i did hear something that was a little bit discouraging to me and that is ver the very limited role for the government and if we keep this for less the commercials that we see as an example of where this all f coud go to. I will start by saying that in the case of the substandard generics or pharmaceuticals the pole for the government is very clear which is to improve the regulatory system and to stop with the kind of owner based faithbased bigotry system and do the kind of inspections and routine testing that is going to verify what is in the drugs. It tells you on the label you had no idea where the manufacturers and drugs are manufactured. If we were to create transparency in this country of origin labeling both for active ingredients and finished drugs, that could really have a market effect because if consumersrs start saying you know, i would rather take a drug is manufactured in the usa, i think that you might see some sort of shift and returned to manufacturing here at home. [applause] i will say briefly we have good people in healthcare. We have great people leading american hospitals, but they are working in a data system. Weve never had to produce real prices before and that is the exciting movement right now. We are starting to see a revolution to be honest prices the nexts question. Youou talked extensively abot theel negligence is going to manufacturing these drugs and the differential health outcom outcomes. The product is a pill. In terms of chemical, molecular analysis of the pill can you detecttc the outcomes of the negligent practices it would seem that that is a variable process. Let me give an example of what is happening in the system if theres no routine testing. So, an investigator went into a plant in china 2017 and noticed something which was it wasnt as required investigating and purity spikes in its own drugs. It wawas making Blood Pressure medicine for the u. S. Market. So, the investigator recommended to the fda this should be a serious distinction on the manufacturing plant. The bureaucrats back in maryland said it doesnt seem that serious. It turns out that france was producing active ingredients are Blood Pressure medication that had a carcinogen. This is the case where the investigator caught it, the bureaucrats said not such a big deal. They were not routinely testing and here we are with millions of americans having Blood Pressure medication that has been recalled. So, you can do routine and systematic testing for carcinogens. Its not cheap but i think that we should demand that because the system of simply looking at the data on paper to figure out whether it is inadequate and there are millions of americans who ended up taking Blood Pressure medication for years that contains this carcinogen. American drugs were imported are the canadian drugs being imported in the same way theres a couple different issues. If we just sort of go outside of the 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, because i think that even though the fda system needs an overhaul i think once we go outside of the system, we are inviting a love of risk. And i think that canadian drugs have kind of taken on this notion for consumers. For American Consumers if you are going online and view our buying from a canadian pharmacy, probably somewhere in the fine print that ishe going to say ife dont happen to have the drug in stock, youre going to purchase the drug from our offshore partners. You never want a drug from an offshore partner. So, i think that in a way, canadian drugs are a bit of a red herring or white herring, whatever you want to call it, and we need to work on fixing our system of oversight regulation of pricing here at home. We just have a few minutes left tha if im going to ask one more question. If you talk about the limitation and the challenges that we have in the variability in and perve incentive it seems that the call to quality and reporting whats happening because we all need a nudge to improve. We allen want to be better lookg and smarter than average and so where do you see transparency going in medicine . I know that theres been a lot of discussions about Price Transparency. It can be easier for the Commodity Services like the chest xray. Consumers can make better apples to apples comparisons. How do we get there . It has to be mature and endorsed by doctors to be used with anything with public reporting. I guard that pretty closely. Price transparency ushers and quality transparency. If there is one your question is do i buy it or not it is too tedious one for 501 for 600, what do you say, i want to know the details of the differences in the quality and experience and longterm outcome so Price Transparency the most exciting thing ive seen are these new relationship clinics that are sprouting up all across the country growing like wildfire and doctors now rejecting what we hate and patients hate and talking about food as medicine into treating diabetes with cooking classes and managing back pain. These clinics are growing all over america that patients are bringing in bags of medication because they dont need them anymore once we address these underlying issues. Thank you for the wonderful discussion and your wonderful contribution. [applause] if you need to pick up books on the way they are in the first over. [inaudible conversations] i had grown women teaching me my body was a commodity and a mean to get things from men and completely acceptable to expect things in return for our companionship for sex and things of that nature. I was told that it revolves around pleasing a man in some form. I was 13. No matter what kind of specific flavor the American Dream you are most interested in or your particular definition, i thinthinkthink agree with his dn involves a large economic component. You with your experiences unfold pretty openly. I dont think people try to hide the fact effective as a badge of honor to have not been in politics and to let the news and fresh opinions on how things should attend debate could begin even when it didnt work out in your favor. Host thank you for joining me today. I thoroughly enjoyed your book i had an opportunity read it and obviously its a very important subject. As you may know i am a pharmacist. Currently the only pharmacist in congress so healthcare is important to me and also i think everyone would agree with that. I think its interesting that you start off the book with the purpose