Transcripts For CSPAN2 Katherine Eban And Marty Makary On Health Care 20240713

Investigative journalist, Fortune Magazine contributor and Andrew Carnegie fellow. Articles on pharmaceutical counterfeiting, gun trafficking and coercive interrogation by the cia have Won International attention and numerous awards. She lectures frequent on the topic of pharmaceutical integrity, bottle of lies the inside story of the generic drug boom, her second book was published by echo harpercollins in may and is a New York Times bestseller. Based on a decade of reporting the book takes readers deep into the overseas manufacturing plants for the majority of low cost and eric medicines revealing and endemic fraud and dire conditions. Educated at oxford where she was a rhodes scholar, Katherine Eban lives in brooklyn with her husband, two daughters and dog romeo. Doctor marty makary is a surgeon and professor of Health Policy 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, lead author of articles introducing a surgical checklist adopted by the World Health Organization and published extensively on healthcare costs, vulnerable populations and quality science, served in leadership in the World Health Organization safe surgery, save lives project and has been elected to the National Academy of medicine, he lives in the washington dc area and i think there is a tv series based on some of his writing. For everyone here we are going to ask about their book, that is going to be 2530 minutes and then in the first tent over it, the books are for sale and there will be a book signing immediately following this at 11 45. Thank you for joining us. I was so fascinated at reading about the story of the generic drug industry, you highlight the challenges with pharmaceuticals. Can you tell us 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 maybe dangerous . Great to be here and thank you for those terrific questions. Bottle of lies the inside story of the generic drug boom is a corporate crime story that takes readers deep into the overseas plans that make our lowcost mostly generic medicine. The project began in 2008 when i was contacted by a radio shows radio host who has an npr radio program. All these patients are contacting me complaining about their generic drugs, either a strange side effect or lack of effect. He was concerned and he had taken those complaints to the fda and their response was it must be psychosomatic. Of patients are changed from one generic to another or brand to generic and it is a different color or size they may have a reaction that the radio show hosted not by that and he posted a question to me, what is wrong with the drugs and that question launched me on a decades long reporting odyssey and though i started with patients and doctors my reporting led me to other continents, india, china, africa as i began to probe what was happening in the distant manufacturing plants that are making our drugs and what i learned is there is endemic fraud in these plants, often highly concealed and difficult to discern but many of these plants are faking quality data or altering data that is submitted to regulators in order to get approval to market their drugs so one of the central questions is what does it mean for all of us and what it essentially means for american patients and others around the world as we may be getting drugs that are not actually bioequivalent but may contain toxic impurities or metallic fragments or particles but in essence the book is really a corporate crime story because i am exposing through internal documents, emails and stories of executives in these companies the profit motive they have to alter this data and get their drugs on the market. As far as fear i definitely fear throughout this project. When i began realizing my reporting would take me to india and china i had a moment, maybe years of how am i going to do that, how my going to do that as a solo journalist, figure out what is going on in these where i dont have many sources and that is probably why the book ended up taking me 10 years. 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. That is the story of internal deliberations, emails and all kinds of regulatory decisions that rarely get publicly exposed. Commissioner gottlieb of the fda has done a great job with generic drug approvals. You talk in your book quite a bit about generic drug approval process and the accelerated new drug applications. I have a surprise to learn from the book about decrease in necessary requirements that can lead to changes in distribution of the drug overtime that led to challenges with will be a trend when it was made generically. Can you talk about the dangers as you do in your book of the challenges in distributing the drug over a shorter period of time and do you have suggestions for how the fda can move from its limited oversight something more to correct upon the status quo . That is a great question with a lot of parts but let me address it by talking about profit motive and regulatory systems, a law passed in 1984, the generic drug industry got its start but one of the questions the industry had was if im going to go ahead and manufacture a generic and dont know if it will get approved and i have to sue the Brand Name Company and it will be expensive what is the deal sweetener . There was a deal sweetener called first file, basically said the first generic drug company that gets through the door of the fda with its application and get approved get 6 months of exclusivity on the us market without competitors. To give a sense how big that is, the Indian Company ranbaxy got a first file in generic lipitor and it made 100 million. Over six months it was worth 600 million. 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 10 cities that sprouted in the fda parking lot, company that would bring their executives in stretch limos overnight where they would take turns waiting online out to be first through the door the fda and when a line would form there were fistfights where one company would push another companys executive out of the way because you had to be first through the door and put your application down the profit motive intense. That is number one. Then theres the problem of regulation. When the fda sent investigators into us plants to inspect, they show up unannounced which you would assume would be the gold standard. Dont tell them you are coming, just show up but overseas because it is difficult and complicated they have a different system. They will announce their inspection sometimes two month in advance. They will contact these plants and say please invite us, we would like to come and will you arrange Ground Transportation and Hotel Accommodations so investigators show up as invited guests of these companies which literally have two month to alter, fabricate documents in one plant but i document they invented Standard Operating Procedures they are supposed to have an steamed documents overnight in a room to make them look old for when the fda showed up. The level of subterfuge i described in the book is remarkable. In answer to your question, how do we fix this, the fda needs to not tell these companies they are coming and that is complicated and difficult because the companies are overseas, we should say to foreign governments you want entry into our market is going to be the requirement. This will be the standard as we are going to show up unannounced. At the moment which we have, which is pretty shocking is an honor based regulatory system. It might surprise some people to know the fda is not systematically testing our drugs. They are looking at data the company submitted order to determine whether they are going to approve and they do these preannounced inspections to make sure the plants are okay. I will say one more thing which is they did a limited experiment in india, call the Pilot Program where for a year and a half that showed no known notice, only short notice or no notice. What they discovered was incredible. Once they got rid of the advance notice they were finding snake and lizard infestations, pigeon droppings all over the place, bathrooms with no drainage piping in sterile sanitary areas, you can figure out the rest of it yourself. So these are the conditions that have a direct impact on quality and sterility of the drug and they have to be closed. Thank you. We will come back to that honor based system in a moment. I will pivot to marty makary and talk about his book. I have to say is a doctor i found it troubling in reading your first chapter, i had chest pain, reading about the perverse incentives and unwarranted variation that you see in care. Can you tell everyone about that queue i was surprised by the things you characterized in that is eyeopening for folks. Thank you, it is great to be here and to learn from Katherine Eban and i hope those medications are not the ones i am prescribing. You might be. What a system. It is great to be here in texas. Thanks for having me. The stories we need to talk about that no one is talking about our areas in healthcare where there is broad consensus among the American People. If we could turn off cable news and stop listening to the echo chambers that we are divided country on healthcare i submit to you there is broad consensus that we need to fix the problems katherine just described, we need to end corruption, stop the disproportionate representation of a small select group of special interests. When there is a pothole in a town it is not a blue or red issue, it is a competency issue and in healthcare the areas i think there is broad consensus our pricing and appropriateness of care and our Research Shows we are doing too much. We asked doctors what percentage of medical care excluding observations of your own practice are unnecessary and they replied an average answer of 25 of diagnostic testing, 22 of medications, 11 of medical procedures. I was at a conference of neurosurgeons who do Spine Surgery and they were telling me they believe half of all Spine Surgery for back pain in the United States is a necessary. I am not a spine surgeon but if they are correct we have a serious crisis of appropriateness. Is in the Opioid Epidemic one manifestation with one medication . There are other medications we have overprescribed sometimes with good intentions and bad science but i chose to open the book with the story the local cardiologist told me about, doctors going to local churches to recruit patients for stents in their legs to open up leg arteries, narrowing in the leg artery. There is very little science to support a lot of it. People often times have no symptoms and yet are being screened in churches, this was predominant in African American churches. In the offices providing Free Health Screenings by local groups. What they were doing was recruiting for unnecessary procedures. We have to tell positive stories. So many disruptors in healthcare. With this problem, i want people to realize throwing more money into the system does not fix it. We already spend enough money to give everybody within our borders good healthcare. We just need to cut the waste. The politicians are talking about different ways to finance the broken healthcare system, not how to fix the broken Health Care System and if we fix it we have to look at pricing failures and appropriateness of care. They billed us after the flight and didnt show prices. They would be price gouging. You might get a bill for 4,000, we dont know if there will be a delay. The pilot might have to go for turbulence and work harder and more complex, good medical coding after they land and you might get a surprise bill for 500 for consuming a beverage. We would say we can get our act together as the Airline Industry has and Price Services so we have a healthy competitive marketplace that end is horrible practice of price gouging in healthcare today which i am concerned is eroding the public trust in our great profession. I felt like as a doctor your story resonated with me. We do a lot of valuebased care but most importantly consumers need to read this book. 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. Talk about the cardiology story which was interesting to me. There is publicly documented challenges in texas, probably everywhere, patients may get unnecessary cardiac stents when they dont require it, 20 or more. Can you talk a little bit about that story and as a consumer how you can be more discriminating what you need for healthcare and what you dont . We are not going to have the government fix healthcare. We the American People are going to fix healthcare by demanding more honesty. Doctors and hospitals have a history of being honest and delivering honesty with patients. If we understand that 20 of Second Opinions are different from the first opinions and study suggest as high as 30 percent40 , you should get a Second Opinion when you are told you need something major. If you have a gunshot wound to the chest and we need to do an emergency thoracotomy, just do what we tell you and dont get a Second Opinion and we are never going to give you a price in those situations, we need to just take care of you but 60 of medical care is shopable. We are told you might need openheart surgery or stand or spine procedure or to start this new medication every day for the rest of your life. Those are opportunities to educate your self. Get a Second Opinion. We dont want to create hysteria but there is wide variation in quality of 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 have become a medical establishment where we have become content with the status quo arguing that it is not a good system but we have not challenged it. 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 infection rates and remission rates and basic quality measures i was told this was crazy and radical and you could never do it at hospital simply cant do it and i promoted this on the book unaccountable. A few years later it became standard and nobody questioned it. We suggested in a study that medical care gone wrong if it were a disease would rank as the third leading cause of death in the United States. We were criticized within 6 months, the story started to come out of children dying in their car because their parent was on opioids. Opioids within a year became the number one cause of death in people under 50 in the United States, that is one manifestation of medical care gone wrong. In the case of the opening chapter of the book, doctors putting stents in leg arteries, we found the United States Preventive Services task force condemns any peripheral vascular screening. When people are told you have leg pain, we want to take a look they should be aware this is one of the patterns where we doctors are concerned about overuse within our profession. There are many examples you given the book, the need for back surgery and undergoing the attempt at physical therapy or cardiac or life stents, as you mentioned. All of those are examples of things that will allow patients to be better consumers a care. We all need to be asking more questions and try when it is reasonable to have less invasive ways, back to your book, Katherine Eban, revisiting the issue of honest accountability, i see the generic drug industry has grown tremendously. There probably isnt a person in this room that is not on a generic drug, a drug manufactured in a different country. You talk about many challenges in outsourcing to that degree because it is hard to hold individuals accountable if they only eat one meal a day and their cultural norms and expectations about quality work products are so different than they are here. Can you talk a little bit about what those challenges are and if you think there is a way to continue to export drug manufacturing in a safe way. As i was reporting the book, one thing i heard a lot about was the issue of culture and how Corporate Culture impacts behavior in manufacturing plants and country culture can impact conduct in manufacturing plants. One of the difficulties is we get as an example 40 of our finished generic come from india. A lot of these plants are in the hinterland of india where companies are employing for example illiterate farmers to do sterile manufacturing as technicians and these are people who dont have training. There is a strong caste system in india so theres not the habit and practice of telling the boss now. But there is also much weaker whistleblower protection. Some of the heroes of this book, the main whistleblower in the book is indian but if you are going to be a whistleblower in india you have no legal protection. It might be a death sentence to complain about practices. You dont have a competent regulator to complain to. We have outsourced or are relying on Manufacturing Systems that are culturally quite different than they are in the us and that is not to say there is no fraud in us plants, that is not true. It is not to say there is no fraud in brandname manufacturing plants up, that is also not true. If you look at the system, one fda investigator said to me when i started investigating these plants, how did anybody in this country think the system was going to work . You have essentially defunct regulators in india who see their role more as being in the service of industry. They rarely show up and you have companies where in order to sign documents they put charts on the wall to show their workers what to write down. That is what is going on in these plants. By and large it is a system that seems absolutely designed to fail us. I also want to say briefly in terms of what marty was saying about what consumers understand or know about these systems it is critical that consumers get educated about what is going on. One fda consultant told me a consumer goes out to buy Cheddar Cheese they understand there is a quality difference between the leader, craft or chatter but what they dont understand is every time they go to a pharmacy there is a quality choice embedded in the kind of prescription drugs they take. Who the manufacturer is makes a difference as far as the quality of that drug. They are not interchangeable as the fda promised us. So fascinating. Can you tell us the one glimmer of hope i had, there are several glimmers of hope but the big glimmer of hope i have been reading your book was the promise of Quality Control. You have always been a pioneer trying to make sure surgical checklists can diminish the unanticipated errors you see in surgery. Talk about the role of Quality Control emerging from medicine and do you think theres a role for that to be publicly transparent . Quality science is a complex science. If it is done in an orderly way or mediocre way it can be counterproductive and create perverse incentives. I have been an advocate for a practice pattern measurement. Lets get off the backs of docs who are trying to practice and tailor treatments to their patients, medicine is an art and treatments should be customized your goals and specific situations, lets get rid of the barriers we deal with all the time, the peertopeer and preauthorizations that dont make sense to drive burnout advocate patterns. Lets look at surgeons who operate on back pain when none of their patients in their 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. Our Research Team has access to them. We published many of them in your own field of breast care. The breast doctors offered the breast fission rate after initial one back to me. If you are calling 10 or 20 patients back saying we didnt get all the cancer, we need to take another surgical incision, that is the normal rate at which an and detect area of cancer can be seen on the edge of the specimen but if you are at 50 , or 60 doctors in that specialty say there is no way to justify. We have gone around to meet with different doctor groups who are practicing not just in the ivory tower and not just at the universities but those on the ground in the United States in rural and small hospitals as well as those who are leaders in Academic Centers asking, tell us about the overuse we can measure in big data and they are telling us, doctors routinely separate upper, lower endoscopies on two summer days they parse it into two days when it should be done in one day routinely. 100 of the time. That is a pattern where doctors are practicing. Sometimes it needs to be done that way. If we can gold card doctors within the normal boundaries of variation, let them practice medicine. Let us practice medicine. Spend those resources helping the outliers as we did in a project with skin cancer surgery, doctors told us doctors who take out too many block or stages per case, removing the cancer with four or five blocks on average of specimens rather than one or 2 which is the average, an area of abuse is taking out too many. When we let outliers know they are outliers 83 reduce their pattern of overuse immediately with confidential dear doctor report cards, civility, reminding people why we went into medicine. They auto corrected. The project which cost 150, 000 saved medicare 27 million and we are seeing massive improvement when we look at patterns and share data with doctors letting them know you are outside of what is considered reasonable by your peers. Can we help you . We are doing it for opioid prescribing, doctors are prescribing 30 opioid pills after a routine lumpeasytomy, you should be getting the with local anesthetic, these are patterns of overuse we should measure and are starting to measure and that is one of the stories i was privileged to tell in the book. We are going to move your questions. There is a microphone in front and in back. Moved to those microphones if you have a question and i will call on you. We have folks moving to the microphone. People will surprise you. A must read for every consumer, bottle of lies the inside story of the generic drug boom read like a grunt genre central even though you know who did it. Theres a combination of various stories in the price we pay what broke american healthcareand how to fix it that i felt Everyone Needs to read it, everyone engaged with healthcare needs to read it. We have a question up front. I was reading about a lady in charge of administrating the hospital in denver and she changed how they managed the hospital and forced them to figure out what did a procedure cost, how much time should she spend, she cut the cost of the hospital 30 without any impact on care and she used methods that toyota uses when they build quality into their cars. How do we incentivize hospitals and doctors to think about how they are running the operation to keep the costs down without hurting quality. The only reason those hospitals are doing that is people like you and americans around the country are demanding prices for basic services. Reflective services you need to demand a price. Heres a secret in the industry, those prices are highly negotiable as before, during, and after the care. If you dont like your bill go to the doctor. Dont worry about bothering us. We need to be engaged. When we told doctors their patients have been gouged or their services and sued in court sometimes to have their paycheck garnished, waitress taking a second job because the hospital garnished her paycheck and this is going on around the country, we are defending patients in court, we win 100 of the time. We are asking hospitals to stop suing patients. A hospital the 220,000 people in the town of 28,000 by census data but i describe in the book, after the book got printed i am proud to report the agreed to stop all lawsuits. Incredible. 50 of americans have less than 400 of cash and savings. They dont live like me. They dont live like us. We need to remember these gains are threatening the public trust in american hospitals and we need to rebuild the trust with honest pricing. [applause] next question. Appreciate it. It does seem to be the general discussion is putting a lot of the onus on the consumer. A lot of us are reasonably welleducated. Even for the more educated, it is pretty tough to navigate our way through all of this. I did hear something that was a little discouraging to me. A limited role for the government in this. If we keep this in the capitalist Free Enterprise thing the commercials we see for drugs, an example where this could go, just think a little bit and talk a little bit about where you do ca role for government in helping us straighten this out because i think it would be bigger than smaller. I would like to see your opinion in there. I will start by saying in the case of substandard generics, pharmaceuticals, the role for the government is very clear which is to improve its regulatory system and stop with the honorbased faithbased regulatory system and do the kinds of inspections and routine testing that is really going to verify what is in the drugs. That is clear. I will say that when consumers have more information, if you know where your groceries come from, you know where your clothing is made because it tells you on the table, you have no idea where your drugs are manufactured. If we were to create transparency there and have country of origin labeling for active ingredient and finished drugs, that could have a market affect because if consumers start saying i would rather take a drug that is manufactured in the usa you might see some sort of shift and a return to manufacturing here at home. [applause] do you want to comment too . We have good people in healthcare. We have great people leading american hospitals that they are working in a bad system. We have inherited this crazy game of inflating prices for the purpose of offering secret insurance discounts and now people i getting hit with those prices and we never had to produce real prices before and that is the exciting movement if you look up prices at fairs of the house. Org, all sorts of ways we are starting to see a revolution to honest prices. I would love to see more price transparency. Next question . You talked about the negligent abhorrent practices the going to manufacturing these drugs and the concerns were differential health outcomes. A product is a pill. I guess my question, what i am interested in is what is the sophistication, there are millions of the entering the country and from various manufacturers in terms of chemical, molecular analysis of the actual pill. Can you detect the outcomes of these negligent practices . It would seem that is a variable or a process that should be of keen importance in terms of seeing what the outcomes are before the drugs are ministered to patients. Let me respond with an example of what is happening in a system where there is no routine testing. Fda investigator went into a plant in china in 2017 and noticed that plant was not, as required, investigating in. Spikes in its own drugs. It was making Blood Pressure medicine for the us market. The investigator recommended to the fda this should be a serious sanction on this manufacturing plant. The bureaucrats in maryland said it doesnt seem that serious. We will make it voluntary action indicated, they downgraded the recommendation, the plant wasnt sanctions. Fast forward one year and it turns out that plant was producing active ingredients for Blood Pressure medication that had a carcinogen in it. This was a case where the investigator cost it and bureaucrats said not such a big deal, they were not routinely testing the drugs and here we are with millions of americans having Blood Pressure medication that has been recalled. You can do routine and systematic testing for carcinogens, impurities, dissolution and stability testing. It is not simple, it is not cheap, but we should demand that because the system of simply looking at data on paper to figure out if the drug passes muster risotto is easily inadequate. There are millions of americans who have taken Blood Pressure medication for years that contains this carcinogen. Last question. Our canadian drugs being imparted the same way american drugs are . Can you speak a little bit . I canadian drugs being imported the same way american drugs are . I canadian drugs being imported in the same way . There are a couple different issues with canadian drugs, politicians who are desperate to announce they have lower drug prices are always turning to the solution of importation of, but if we go outside the fda system and import from a country that has lower drug prices that will solve all our problems. Importation is an issue that is on the table in a big way. I have some concerns about that. Even though i think the fda system needs an overhaul, once we go outside the system we are inviting a lot of risks. And i think canadian drugs have kind of taken on this mythic notion for American Consumers, it is to the north, the snow must meet your and weight. That is a bit of a canard and often for American Consumers if you are going online and buying from a Canadian Pharmacy in the fine print it will say if we dont have the drug in stock you are authorizing us to purchase this drug from our offshore partners and i will tell you this, you never want a drug from an offshore partner. In a way canadian drugs are a bit of a red herring or a white hearing and we need to work on fixing our system of oversight regulation and pricing here at home. We have a few minutes left, i want to ask debra pratt marty makary one more question. The challenges that we have on unnecessary variability and perverse incentives it seems the call to quality and reporting, telling physicians from physicians what is happening because we all need a nudge, we want to be better looking and smarter than average, where do you see transparency going in medicine . There have been a lot of discussions about price transparency. It can be easier for commodity Like Services like the cdc. Do you see efforts to become more transparent so consumers can make better apples to apples comparisons and how do we get there . Quality metric has to be really mature and endorsed by doctors practicing in that area to be used for anything but public reporting. I guard that pretty closely. Price transparency ushers in quality transparency, your question is your brain thinks do i buy or not . A two tvs, one for 500, one for 600 what do you say . I want to know the details and differences and quality and experience and longterm outcomes. Price transparency invites policy transparency. The most exciting thing i have seen in healthcare our relationshipbased clinics that are sprouting up across the country, growing like wildfire. Doctors rejecting the billing throughput model of care we hate and patients hate, spending time with folks, using the team, talking about medicine, treating diabetes with cooking classes, managing back pain with ice and physical therapy instead of just surgery and opioids. These clinics are growing all over america and take the form of direct primary care, Medicare Advantage plans, oak street, they are revolutionizing healthcare and patients are bringing in bags of medication because they dont need them anymore once we address these underlying issues that drive our crazy cost crisis and illness. Thank you for a wonderful discussion and your wonderful contributions. You did a great job. If you would like to join us at the book signing tend it is two over and if you need to pick up the books along the way, they are the first tend over, thank you. [inaudible conversations] now live to london for british Prime Ministers question time. And we bring you Prime Minister Boris Johnson taking questions from the house of commons live wednesday mornings on cspan2. We invite your participation via twitter to hashtag pmqs. Part question time members are finishing their business. Live to the floor of the british house of commons. Would like to just a point of order make a short statement. Number one mr. Speaker. Prime minister. Mr. Speaker, the whole house will want to join in paying tribute to Lance Corporal freddie guillen, a reservist medic from the scottish and north irish yeomanry who was tragically killed in iraq last week. My thoughts and deepest somebodies are with her family and lov o