or NASH, sponsored by the American Association for the Study of Liver Diseases and the Global Liver Institute. I'm Dr. Ray Chung, president of the AASLD and director of Hepatology in the Liver Center at Massachusetts General Hospital. AASLD is the leading organization of scientists and health care professionals committed to preventing and curing liver disease. We foster research that leads to improve treatment options for millions of patients suffering from liver disease and advance the science and practice of hepatology through our programming. Among the many liver conditions we care for, NASH far and away represents the most frequent and pressing of these. Before we begin, I want to address a housekeeping item. Because we are using Zoom's webinar platform, all audience members are muted throughout the discussion. But we will be taking questions at the end. To ask a question, use the Q&A function to type your question. You can submit those questions now and throughout the presentation. When submitting a question, please include your name and the full name of your organization or congressional office with your question. I'm delighted to be joined today by Donna Cryer, president and CEO of Global Liver Institute. And I will turn it over to her to introduce herself and our congressional speaker. Thank you so much, Dr. Chung. And thank you all who are joining us today to discuss this very important issue. The Global Liver Institute is a patient-founded, patient-led, patient-informed organization headquartered right here in Washington, DC. As a 501c nonprofit organization, we are focused on improving the lives of individuals and families impacted by liver disease by promoting innovation, encouraging collaboration, like the one we have today, and scaling optimal approaches to help eradicate liver diseases. We have affiliations in 42 states and are so proud to be working with partners in 73 countries as well. The issue that we're talking about today affects so many Americans. It has gone unrecognized for far too long that since everyone has a liver, everyone is at risk of or already has some degree of liver disease. This is why the Global Liver Institute, working with partners like ASLD, feel it's so important to bring that experience from patients from communities around the country to be represented here in Washington, DC, to shift the conversation towards liver health and liver health solutions. We can do a better job of responding to liver conditions like the one we'll be focused on today, non-alcoholic steatohepatitis, or NASH, which is the advanced form of fatty liver disease. We can effectively move the needle in NASH policy. We strive to synchronize advocacy efforts across more than the 70 members of our NASH Council, and that includes ASLD, who is our co-host for this briefing. We have leaders in hepatology, and I'll just take a moment to say this is the 27th anniversary of my liver transplant. And so without gastroenterologists and hepatologists, those who are represented here today, standing with and partnered with patients, I would not be alive today for this briefing, and I would not have enjoyed the past 27 years of life. And that is what we hope to bring to more and more patients. We firmly believe that collectively, moving liver health advocacy with a patient voice and perspectives, bringing our lived experience to the center, we can ensure that liver health is an integral part of public health, from nutrition, activity, prevention, control and management of risk factors, to education, support, optimal clinical pathways, and policy for the children, adults, and seniors who are affected. We are honored that the advocacy efforts that we have been putting forward are fruitful, and they are bipartisan. And so we recognize our Democratic co-sponsor, Mr. Ruiz, who could not be with us today, but we are so grateful to share a special message from a member of Congress who has not only heard, but responded to with action to the liver patient, physician, and liver community voice, U.S. Representative Dan Crenshaw of Texas. Congressman Crenshaw represents Texas's second congressional district. He is a former U.S. Navy SEAL. He is now a true leader in Congress. He has established himself able to work across party lines, leading to tangible results, first as ranking member of the Homeland Security Committee's Oversight Management and Accountability Subcommittee. And now in his second term, we were excited to see him at the Energy and Commerce Committee, where he can spend more time on one of his other passions, healthcare. During the early parts of his congressional term, we've already seen him lead the way on issues like drug affordability, personalized healthcare, and most importantly for us today, liver health. In late 2020, Congressman Crenshaw and Congressman Ruiz originally led the way in NASH health policy by taking the critical first step necessary to respond to the rising concerns of this life-threatening chronic liver disease by introducing the NASH CARE Act. The bipartisan NASH CARE Act opens the door for the U.S. federal government to survey, prevent, and address NAFLD, NASH, and interrelated diseases and conditions like diabetes. And we look forward to the bill's reintroduction in the very near future. On behalf of all Texans, and my board chair is a Texan, so he's maybe an honorary Texan for today, and Americans across the country impacted by NASH, we could not be more appreciative of Representative Crenshaw's continued leadership on liver health. Thank you. Thank you to the American Association for the Study of Liver Diseases and Global Liver Institute for hosting this briefing, and for your support of the NASH CARE Act. NASH, which stands for Non-Alcoholic Study of Hepatitis, you can say that five times fast, is not a disease that you may be familiar with at all. It's one of the many diseases that is hardly researched, and as a result, has very few cures. NASH ends up falling through the cracks because the disease often becomes the result of type 2 diabetes, heart disease, and chronic kidney disease. My constituents in Texas are even at higher risk for NASH, and chronic liver disease is the eighth leading cause of death in Texas. And since NASH occurs commonly with diabetes, cities like Houston with high rates of diabetes see higher rates of NASH. The bill takes a critical first step forward in treating NASH, closing gaps in what we know and need to know about how to treat it, as well as training doctors and other providers in how to spot patients with NASH. But we shouldn't stop there. We're looking for better ways of treating complex diseases like NASH. Primary care doctors should be treating these diseases holistically, and seeing how one disease might lead into another. Our doctors must be empowered to make decisions based on the entirety of a patient's health, but our current system does not allow for that. That's exactly what my bill does, and that's why the NASH Care Act is a critical step in the right direction, giving doctors the tools they need to treat patients holistically, and hopefully making progress in the fight against this disease. So thanks for all the work that you do, and for your support in this fight. What I'd like to do next is introduce our panel for today's briefing. I'll introduce our panelists in the order that they will present today. First, we will hear from Dr. Allison Goodman, who's a board-certified pediatrician and medical epidemiologist in the Division of Nutrition, Physical Activity, and Obesity at CDC, and a commander in the U.S. Public Health Service Commissioned Corps. She received her MD and MPH from Emory University, completed a pediatrics residency training at Boston Children's Hospital and Boston Medical Center, and a postdoctoral fellowship in applied epidemiology with CDC's Epidemic Intelligence Service. Dr. Goodman's role as lead for the Obesity Prevention and Control Branch's Population Health and Healthcare Unit includes increasing delivery of evidence-based interventions for child obesity prevention and treatment, and a robust informatics portfolio to improve data capacity for research, surveillance, and evaluation, as well as clinical and population health decision support. Our next panelist is Dr. Mary Ranella, a professor of medicine at Northwestern University Feinberg School of Medicine and director of the Northwestern Fatty Liver Program. She received her MD from the University of Illinois and completed her residency training at the University of Chicago and a fellowship in gastroenterology and hepatology at Northwestern, where she remains on faculty. She studied the basic mechanisms of NASH with the support of the National Institutes of Health for 10 years. Her primary clinical and research focus is on the associations between NASH and other metabolic comorbidities, emerging NASH treatments and the recurrence of NASH after liver transplantation. She recently established a multicenter consortium to study the risk factors for liver disease recurrence and outcomes of patients transplanted for NASH cirrhosis called the Nail NASH Consortium. Our final panelist is Ms. Terri Milton. Ms. Milton is a fourth generation Texas native residing in Texas's second congressional district. She's been married to her husband, Doug, for almost 36 years and they have three adult children and seven grandkids. She enjoys gardening and reading and she and her husband also collect antiques and enjoy finding small shops in odd places. In 2017, Terri was diagnosed with NASH cirrhosis. One year later, she was diagnosed with hepatocellular carcinoma and has had four localized regional treatments for this cancer. She is currently on the transplant list awaiting a second chance for a life-giving liver. She's a graduate of the Global Liver Institute's Advanced Advocacy Academy and was invited to speak on a panel of NASH warriors at the liver meeting in 2018. She's been regularly featured in Hep magazine as well. She currently manages a large cirrhosis group on social media, is creator administrator for the Clean Nutrition University, also on social media and several other groups that deal with specific details of her journey with fatty liver disease and liver cancer. She remains an active liver health advocate with the Global Liver Institute and has recently been involved with the Texas Liver Foundation and be part of an educational panel of speakers about the importance of nutrition and fatty liver disease. With that, I will turn it over to our first speaker, Dr. Goodman. Good afternoon and thank you for having me today. It's a real honor to serve on this panel. Next slide, please. So I work in the Division of Nutrition, Physical Activity and Obesity at CDC and the National Center for Chronic Disease Prevention and Health Promotion. And the vision of our division is a world where regular physical activity, good nutrition and healthy weight are a part of everyone's life. The mission is to lead strategic public health efforts to prevent and control obesity, chronic disease and other related health conditions through, again, regular physical activity and good nutrition. Next slide, please. DNPAO works across the lifespan to help Americans achieve healthier lives and to avoid chronic diseases by encouraging regular physical activity, good nutrition and healthy weight. So we work on healthy start for infancy through breastfeeding, maternal, infant and toddler nutrition, vitamins and minerals. We try to support children and youth growing up healthy and strong and helping adults and older adults maintain a healthy lifestyle over time. Next slide, please. As you can see, this work is needed as obesity rates among children have been rising since the 1990s through this slide has data up through 2018 which is the most recent data available for children. Over 14 million youth in the United States are living with obesity. That's one in five children. Next slide, please. In 2017 to 2018, 42% of adults are living with obesity and 9% had severe obesity. Likewise for children, we have 19% with obesity as you saw in the last slide with 6% having severe obesity. So sort of now why are we talking about obesity and NASH and NAFLD? NAFLD is currently, you're gonna hear a lot more about the most common liver disease estimated to affect about 33% of adults worldwide. It can progress to hepatitis, fibrosis, cirrhosis and hepatocellular carcinoma. So research on the causes of NAFLD are ongoing. However, what the research suggests is that certain health conditions, including obesity make individuals considerably more likely to develop NAFLD or non-alcoholic fatty liver disease. Additionally, people with NAFLD are more likely to have NASH if they have obesity, especially for those who have a larger waist size. So with the increasing adoption of the Western diet and the sedentary lifestyle in the US, the prevalence of obesity, insulin resistance, type two diabetes, lipid disorders and metabolic syndrome have all been increasing. And individuals with these disorders have a propensity to accumulate abnormal fat deposits in their liver, again, known as NAFLD. No medications have been approved to treat specifically NAFLD and NASH. The current recommendations for treating NAFLD is weight loss, right? And BMI reduction, improvements in nutrition, physical activity and healthy living. So in other words, obesity prevention and treatment is NAFLD prevention and treatment. Next slide, please. Unfortunately, the twin epidemics or pandemics of obesity and COVID-19 have led to compounding effects that are important to understand regarding the association of NAFLD and obesity and sort of the pressing need to intervene. A recent CDC author report that included over 43,000 patients aged 18 years and younger found that among children and adolescents with COVID-19, underlying medical conditions increase the likelihood for hospitalization and severe COVID-19 illness. The report found that over one quarter of hospitalized patients had one or more underlying health medical conditions and their strongest risk factors for hospitalization were type 1 diabetes and obesity. The strongest risk factors for severe COVID-19 illness, including ICU, admission and face and mechanical ventilation or death were type 1 diabetes, congenital anomalies, hypertension, epilepsy and obesity. And many of these conditions are, of course, related to NAFLD. During the COVID-19 pandemic, children and adolescents spent more time than usual away from structured school settings and families who were already disproportionately affected by obesity risk factors might have had additional disruptions in income, food and other social determinants of health. As a result, children and adolescents experienced circumstances that accelerated weight gain, including increased stress, irregular mealtimes, less access to nutritious foods, increased screen time and fewer opportunities for physical activity. In another recent CDC author report that included over 400,000 children aged two to 19 years, we found that youth experienced sharp increases in the rates of BMI gain during the pandemic. We found that in the study population, the rate of BMI growth approximately doubled during the pandemic period compared to the pre-pandemic period. Youth with overweight or obesity before the pandemic were most affected by BMI increases during the pandemic. And the rate of BMI increases significantly higher than that of children with healthy weight. Youth with moderate or severe obesity gained on average one and 1.2 pounds per month respectively, which is about double, again, that pre-pandemic period. And those effects were most pronounced among school-aged children aged six to 11 years. So childhood obesity, which was already a significant issue before COVID-19 is growing at an alarming rate and causing worse health outcomes for children. Next slide, please. Actually, sorry, back up one. Thank you. Children with obesity face increased health problems in the short and long term, including fatty liver disease and certain types of cancer, including liver cancer. NAFLD is the most common cause of chronic liver disease in children in the United States and published research estimates that close to 10% of U.S. children aged two to 19 years have NAFLD already. As you saw my earlier slide, we see both adult and childhood obesity rising. So it's not surprising that NAFLD has become more common over time as well. Even more concerning are findings from a new study that's pending publication that suggests that despite clinical care recommendations, most at-risk children are not being screened for NAFLD in their primary care settings. And about half of children in this study who already had obesity that we identified appear to already have NAFLD. And the frequency of NAFLD was even higher for children with more severe obesity. So just as for adults, current NAFLD treatment recommendations for children are about BMI reduction. Next slide. So again, treating obesity is also treating NAFLD and preventing obesity is preventing NAFLD. And DNPAO has several programs that include strategies around obesity prevention and treatment. The State Physical Activity and Nutrition Program or SPAN, CDC funds 16 state recipients to implement evidence-based strategies at the state and local levels to improve nutrition and physical activity. In the High Obesity Program or HOP, CDC funds 15 land grant universities to work with community extension services to increase access to healthier foods and safe and accessible places for physical activity in counties that have more than 40% of adults living with obesity. And in the REACH Program, the Racial and Ethnic Approaches to Community Health, CDC gives funds to state and local health departments, tribes, universities, and community-based organizations to reduce health disparities among racial and ethnic populations with the highest burden of chronic diseases, such as hypertension, heart disease, type 2 diabetes, and obesity. Recipients work through culturally-tailored interventions to address preventable risk behaviors, including tobacco use, poor nutrition, and physical inactivity. Next slide, please. DMPAO also funds specific work for childhood obesity, including research, public health practice, data capacity-building projects, and health systems teams across the U.S. On this map, you can see locations of our Child Obesity Research Demonstration, or CORD, grantees, the locations of engaged federally-qualified health centers participating in our COMMIT project to improve child obesity prevention and treatment care quality, and the locations of our Clinical and Community Data Initiative, or CODI, a data capacity-building project that I'll share more details about in a few moments. Next slide, please. Since 2011, CDC has conducted the Child Obesity Research Demonstration projects to support grantees that test and apply the most promising obesity prevention and management strategies, and find affordable and acceptable solutions that can benefit the millions of children eligible for the Children's Health Insurance Program, or CHIP. Through our current Child Obesity Research Demonstration projects, or CORD 3.0, we focus on finding the best way to implement the U.S. Preventive Services Task Force Grade B Recommendations for Childhood Obesity, which include family-centered, intensive, behaviorally-based pediatric weight management interventions that focus on nutrition and physical activity, as well as behavior modification and parenting skills. Lessons learned from the current and prior iterations of CORD include that families want access to quality weight management programs in clinical or community settings, in individual or group formats, and through a variety of modalities, including virtually from home. Time spent in these programs is key. In other words, dose and intensity matter. Better attendance leads to better improvements in weight and other very important health and social outcomes. And all settings matter across a community in supporting children and families as they move through their day, prevention and treatment should be available in the places where families live, work, play, et cetera. Next slide, please. In 2018, CDC began partnering with the National Association of Community Health Centers, or NAC, to expand implementation of an effective childhood weight management program in federally qualified health centers, and to improve evidence-based clinical care quality for child obesity prevention and treatment. Sixteen FQHCs are using a childhood weight management program called MEND, the Mind, Exercise, Nutrition Do It program, which is a comprehensive family-based intervention that helps children age 7 to 13 years who have or are at risk of having obesity to improve their health, fitness, and self-esteem. In addition, during 2020 and 2021, we launched the Commit Learning Community, through which clinical care providers at additional federally qualified health centers across the country are gaining skills and tools for incorporating obesity prevention and treatment best practices into pediatric primary care, including linkage with community resources. CDC and NAC use information from this project to identify components of successful program delivery in the sites that are serving our low-income families, and to develop adaptable, accessible, and scalable solutions to expand similar programs. Next slide. To fully understand the problem and opportunities for intervention, we need data. Of course, in CDC, we do data, right? But we need these data to understand when obesity screening is occurring and the actions that it triggers, for example, screening for NAFLD. We need to assess and compare the effectiveness of interventions in the real world. We need to be able to look at what dose and characteristics of interventions work best for which children and which subpopulations, and we need to address gaps in obesity surveillance, quality improvement, and chronic disease program evaluation. And these data exist, but they're maintained in disparate systems siloed across a community. So, funded by the Patient-Centered Outcomes Research Trust Fund and CDC's Data Modernization Initiative, our CODI project works toward bringing these distributed systems and data together by leveraging and enhancing existing health information technology tools to facilitate access to individual-level linked longitudinal clinical and community data, including clinical information about NAFLD. The health information technology tools developed and the resulting linked clinical and community data can enable researchers to better understand whether interventions work, use EHR data for public health surveillance, and enhance data capacity for health care quality improvement and public health program evaluation. Next slide. Thank you very much. Hello, my name is Mara Rinella, and it is really an honor today to speak to you about the importance, societal importance, and general importance of fatty liver disease, and the important, the opportunities to improve this disease in the care of patients, ultimately, with fatty liver disease. Next slide. Fatty liver is a complex disease, which starts with fat development in the liver called steatosis and can develop an inflammatory subtype called nephrocytohepatitis. This is the stage of disease that is most... cancer, liver failure, and the problems that go along with that. This is largely driven by environmental factors in the background of genetic predisposition. Next slide. So the scale of the problem in the United States is quite sizable. The estimated number of people in the United States with fatty liver disease overall is about 80 million. The estimated number of patients who have NASH or steatohepatitis is 16.5 million. And the estimated number of those who have advanced disease, which we consider to be cirrhosis or F4, or pre-cirrhosis, called F3, is about three and a half million people. Next slide. Most concerning, though, is that modeling data demonstrate that by 2030, we are going to have not just a numeric increase in the overall number of people with fatty liver disease, but we are going to have 168% increase in those with decompensation, meaning the liver stops working and doing its basic functions, 178% increase in liver-related deaths in the United States, and 137% increase in hepatocellular cancer. Next slide. Thanks. So the prevalence of NASH with advanced fibrosis, which is the type that is most linked to severe disease, is actually quite significant. As I mentioned before, 16.5 million, but only 1 million of these are diagnosed. Next slide. And in essence, the reason why we're really even here talking to you today is because of the increased liver failure that we're seeing due to NASH. So you can see here on the top graph that the rates of NASH-related listings for liver transplantation are up both for alcohol and NASH. And below, if you look at it as full change since 2002, you can see that there's been a five and a half fold increase in NASH and a comparatively less fold increase in alcoholic liver disease. Next slide. And importantly, this is fatty liver disease, or NASH, is the most impactful etiologic factor increasing the rates of liver cancer at this time. You can see a 24-fold increase, actually, from 2002 to 2018. Next slide. And so why does it matter? There's, of course, serious burden of disease to patients, but the cost is also quite substantive. So if you look at early stage disease, which we could define as F1 to F3, and F stands for fibrosis or scarring, you can see that there is a tenfold increase in cost of just having cirrhosis. And then if you add on to that the decompensation, meaning the lack of function of the liver, which starts to develop multiple medical problems, increased hospital admissions, et cetera, the cost increases, hepatitis C or cancer, 89,000 per individual, liver transplantation, 188,000 per individual. And this is, again, these are average numbers and can be actually quite high depending on location in the country. Next slide. So the diagnosis is obviously then very important. So as I mentioned, there are many that are not diagnosed or fall under the radar. Approximately 6% are suspected to have a diagnosis, but only 20% have actually received proper diagnostic testing. And among those who have biopsy confirmed NASH, 25% have very advanced disease. Next slide. So can advanced liver disease be predicted noninvasively, so without a liver biopsy? Next slide. And the answer is it most certainly can. And in fact, it can be diagnosed with tools that are readily available to general practitioners, you know, at no additional cost, and they basically need to be implemented. So there are risk calculations noted on the left that are derived from just blood work that you would normally get on a patient. More complex ones, can you go back, please? One called the enhanced liver fibrosis test, which was just approved by the FDA about two weeks ago, which is able to identify the risk of progression in people with fatty liver disease and NASH. And then there are point of care tests such as fibroscan or elastography that are able to further risk stratify patients at a point of care in a doctor's office. And these can all predict clinical outcomes and predict who is likely to die from disease or not. Next slide. So there are several algorithms that have been developed. This is one that's in press right now, but we can basically take non-invasive tests that are readily available and derived from laboratory tests and use that to make clinical inference and then adjust the clinical response of the primary care doctor. And you can see here the details of which are unimportant, but globally, for you to understand that we are able to do this, we can rule out advanced disease and take those patients out of the healthcare system, at least from a treatment perspective with a hepatologist, and then identify those with advanced disease that really need focused care in order to prevent the development of progression of disease and liver-related consequences and death. Next slide. So what do we do for management? So there are key concepts from a high level that I think are important to understand from a treatment perspective, and Dr. Goodman really outlined them very nicely. In the short term, it's really to improve disease activity and to prevent the development of further scarring. In the long term, of course, it's to reduce the progression of cirrhosis because cirrhosis has all of the clinical outcomes that we're trying to avoid, including death and very high cost. Next slide. Now, there's a significant amount of activity right now in development with drugs being evaluated for the treatment of NASH, but we are not to a point where we have anything FDA approved, nor will we for a few years. Next slide. By far and away, the most important thing and most impactful thing we can do is to work on nutrition and activity levels, as outlined by Dr. Goodman, in children, which is also true in adults. The biggest problem, though, is the nutritional therapies lack sustainability and attainability, and at best are typically less than 15% in a year. So in this New York Times article, this illustrates very nicely the difficulty with sustaining weight loss. These are an article based on The Biggest Loser, season eight, and you can see here that, unfortunately, six years after the show ran, 13 of the 14 contestants had regained the weight, and six years after, four of them are actually heavier now than they were before the competition, and this is actually reflective of what we see in real life. Next slide. If we are able to help and support our patients to lose weight, we do know that improvement in weight, further weight loss, is associated with incremental improvement in the liver disease itself, including improvement in scarring, which can occur by 45% in those that lose more than 10% of their body weight. So next slide is fine. So there we go. So how can we achieve this? I think the best way to achieve this is using a multidisciplinary approach. It is not tenable for hepatologists alone to manage these patients, nor is it effective. It is critical to have a multidisciplinary approach that involves nutrition, health psychology, endocrinology, and sometimes cardiology to help optimally manage these complex patients. Next slide. So increasing NASH awareness is really at the center of how we can start to tame this problem. And for example, awareness and prevention initiatives through campaigns, information, collaboration, and increasing visibility, targeting high-prevalence groups, for example, a high-risk screening, high-risk groups such as diabetics, those with metabolic syndrome, or those with severe obesity, or targeting campaigns, providing weight loss services, and then training the workforce, which is absolutely critical. Next slide. So this is an example of how a governmental program can dramatically change the face of a disease. This is actually, the example here is one from Australia where now HCV hepatitis C infection is nearly eradicated, something that many countries in the world, including our own, would like to see come to fruition. But through implementing screening and testing, direct referral for treatment, and governmental investment, there is now a significant improvement in the diagnosis and actually the eradication of hepatitis C in general in Australia. So we can do, we can certainly do this. Next slide. So these are data from a paper published recently in an excellent journal called Nature Reviews, Gastroenterology, and Hepatology, which came up with eight recommendations for improving models of care in fatty liver disease and some NAFLD and NASH. And they center on the what, where, who, and how to do this. What is developing guidance on screening testing with non-invasive tests, establishing patient-centered pathways tailored to each disease stage, outlining actions to prevent disease progression, develop guidance on treatment strategies, where to articulate the goals and interactions between primary, secondary, and tertiary care providers, to establish where co-location of services, for example, the multidisciplinary models that I discussed, could occur, and to define the composition and structure of these multidisciplinary teams that are responsible for managing these patients, and then finally, to establish systems for coordinating and integrating care across the healthcare system. Next slide. So in parallel to this, and soon to be published as well, is a NAFLD consensus statement that was derived using a Delphi process that resulted in 37 consensus statements and 26 recommendations. These were developed by 281 experts from across the world. The effort was led by Jeff Lazarus, and many of us participated in this process. And this basically set the framework for what we need to do, which is also very nicely outlined, and you've hopefully already seen through the NASH CARE Act. Next slide. So this, again, reiterates many of the aspects that we are trying to present through the NASH CARE Act, providing leadership for the NAFLD public health, illustrating the importance and magnitude of the human and economic burden, increasing awareness, developing treatment modalities, defining and implementing models of care, and developing and fortifying public strategy for a whole-of-society approach that includes numerous stakeholders. And so this is what it will take to advance the NAFLD public health agenda. Next slide. So to summarize, I really think that this centers on increasing awareness at all levels, and this means the public, it means the government, it means the physicians, it means incorporating into medical school curricula. So education, engagement of the NAFLD community. Next slide. And then from an action perspective, to collaborate across disciplines, to establish models of care, and advancing the public health research agenda so that we can develop not only further and more robust diagnostic tools to noninvasively identify patients who are at risk, but also to develop treatments that can help us in addition to nutrition and weight loss to help curb this very serious disease. And with that, I thank you very much for your attention. Good afternoon. Hi, I'm Terry Milton. And just wanted to say hi, y'all. So I am from Houston, Texas. I do live in the 2nd Congressional District. And I am honored to be here. So thank you, Dr. Chung. Thank you, Donna, for inviting me and for giving me the opportunity for definitely being here. In 2017, I was actually in 1998 goes back even further than that. I was diagnosed with fatty liver and my doctor at that time gave me the recommendations that he had based upon the education he had, which was not to worry about it. And so I didn't, as I didn't think of my liver at all until 2017 when I had elective surgery to have my gallbladder removed, which was causing a lot of problems. My surgeon at the time afterwards came up to me and said, I had went ahead and did a biopsy because there was some nodular contours of your liver and I'm concerned. And so he did do a biopsy and a couple of days later, as I, as at my request, he called me. So I know that's not the norm. Usually it's a face to face, but I had asked him, please call me. I'm okay. And so he did. He told me two things. One is that I had cirrhosis, you know, is that's what, what the biopsy had revealed. And I I'm, I'm sitting there completely flabbergasted because I don't drink. And, and my only understanding of cirrhosis at that point in time was that it was caused by alcohol. Um, I had no awareness. And then he said I had, it was caused by something called Nash. And I didn't, had no idea what that was. And so I did what anybody who's, who's newly diagnosed does is I went on the internet and I hit Dr. Google and, um, without realizing that Dr. Google, uh, failed medical school. Um, so I was scared to death with all the different things, uh, that I read, uh, is bad information. Uh, the number of supplements that, that are touted there to try to treat me, uh, friends who all of a sudden had miracle cures and books that I needed to read. And, but instead is I was definitely going through something. Um, I had gone from an unknown disease to being completely symptomatic, uh, within five days, I had gained 40 pounds in, uh, in ascites. Um, and I was hospitalized right before Harvey hit Houston, actually. Uh, so that was a, a definitely a big storm for me on a, on a couple of different fronts. Um, a month later, as I was diagnosed, or I was again, hospitalized for, uh, for ascites and had my first paracentesis. So going from decompensated to compensated or from going from compensated cirrhosis, which means no symptoms to being decompensated, meaning that I had symptoms, uh, was traumatic. The other thing was, is, is in October of 2017. So that happened in August of 2017, October, 2017, I was hospitalized with my, uh, my first hepatic encephalopathy episode. And, um, I'm a communicator, uh, as I, um, like to, to talk as I teach, uh, I write courses for people. I write courses as I, I end up, uh, doing training and all of a sudden as I wasn't able to communicate effectively and was, was, uh, was put in the hospital. Um, um, there's a lot of different things that have happened since then is in May of 2018, I was diagnosed with my first tumor, uh, for HCC. Uh, I have since then I've had three tumors and four treatments. And unfortunately a week ago, Monday, um, as I had my follow-up appointment for my every three month MRI, and they found another two tumors. And so I meet with interventional radiology tomorrow to see what the new treatment's going to be. And not only that, but I have a very large blood clot that's, that's blocking the main vein into my liver. And so, or it's, it's partially blocking it. So it's not completely. One of the things that, that I really want to convey is this, is that one, I never saw myself in this, you know, just, um, I live life, uh, looking back is, is in 2012, I had an aunt, one of my favorite aunts who passed away with cryptogenic cirrhosis and she died in a hepatic coma. And so I think now that it probably was Nash cirrhosis is probably what she had. I am a Hispanic female and, and know that that is genetically a possibility. Um, I have become passionate about telling my story of making sure that other people know that I'm not the only voice out there, uh, that there are so many other patients that, that completely and fully are, are impacted by this on a daily basis. And they're, they're still not, um, fully aware of what to happen. Uh, I had a Nash, uh, patient join recently on one of my groups and her response was, um, I have Nash cirrhosis and my doctor just said, don't worry about it. It's not a big deal. And, and I wanted to cry for, I truly, truly wanted to cry for, because she was needing answers and she didn't have those answers. And, and that's my, in the liver cancer group that I, I admit, I get five to seven people every week who join, who are, who have HCC that originated with Nash. And they didn't find out until they had upper right quadrant pain. So that's usually something that makes people go to the doctor. Hey, doctor, as I'm having pain right here, what is this? And, and then cancer's found. So it is, I'm not the only person it's, it's, I'm not a lone voice that is, is just, is saying this. My hope from, from all everything that I, that we're saying today is, is this one, one understanding, uh, the Nash Care Act is step one. It's, it's step one. Uh, very honestly, it is the beginning of understanding how to get ahead of an epidemic that is hitting our country. That is hitting our children. Um, I had one lady who joined her, her 13 year old daughter has Nash and it has progressed to cirrhosis, a 13 year old. When you look at the faces and not just the numbers, it becomes more real. It becomes more real. When you look at people around you is, you know, um, I have learned to speak the language. In fact, as, as I've got a funny, a funny thing, um, I have been having some shoulder problems. So I had to go to an orthopedic surgeon and he ran, she ran some, some films and everything. And I was looking at it and I looked at her and I started laughing. I said, I speak liver. I don't speak bone. And, um, so I've learned to speak liver and, and I've, I've learned to, to look in and see, um, people around me and they're not aware. Um, it is getting better, uh, is no longer when I go to the ER and those ER visits are frequent, unfortunately, is now the ER doctors know what NASH is. That's progress. I was doing a lot of educating in the early years of, okay, this is what it is. These are the symptoms. This is how I got it, you know, and, and helping to, to educate them. And I, and don't, don't get me wrong is I, I respect the job that they do is just sometimes they, they don't know. Um, I went to my primary care doctor who was getting ready to, um, to start a diabetic clinic. And with it as part of this practice, I said, if you're going to do that, if you're going to start that aspect, then can you please start the liver screening along with it? Because the two go together, unfortunately, is that mean that 100% is going to always be no, and that's a good thing, but stop it before it gets to there. Um, when I talked with one of the pharmaceutical companies, one of the things as I asked, I said, can, is there any way to make sure that as a part of the education of the medication that you eventually will put on the market is nutrition because they have to go hand in hand. It cannot be cured by just a pill. And so that's why, as I have a nutrition group that I, that I talk about is, is that it's not diet, it's lifestyle and it's lifestyle. That's going to go for the rest of your life. And it's not just what you eat. It's how you act. It's how you move and it's how you think, um, you eat to live, not live to eat. You all have within your grasp the opportunity to make a difference. And I know that without a doubt that you can. So that's my ask today. Definitely without a doubt is say yes, the NASH CARE Act, talk about it, learn about it, definitely get it on your mind. And then if I can ask you one more thing, can you go get screened? Look at your family. Is there anybody in your family that maybe needs to do it? Stop it now before it progresses and goes any further. Thank you so, so very much. Thank you so much, Terry, for that extraordinary story. It really was incredible, impassioned, and, and very moving for all of us. And I want to thank Mary Ranella and Dr. Allison Goodman for their extraordinarily clear and lucid presentations. And I would invite those of you in the audience to submit your questions through the Q&A function on your Zoom. And perhaps as we await those questions, it might be worth asking the panel. Perhaps, you know, we've seen how extraordinarily abundant this condition is. And I wonder if you think that we should adopt a broad population-based screening approach, or should we target our screening to more focused risk groups that have been described here? Perhaps we could hear from each of our panelists on that. I'm happy to. Our NASH Council, which has been in conversations since 2017, with very active conversations from hepatology, with very active conversations from hepatology, cardiology, endocrinology, these specialist and adjacent conditions, you know, surrounding, surrounding the liver, you know, as Terry pointed out, and as Dr. Ranella said in her, in her slides, really, I think it's most important to, at this point, to be screening every patient with type 2 diabetes. You know, we know about the interrelationships between NASH and diabetes, with perhaps in some practices, 70% of patients with type 2 diabetes also having some form of fatty liver disease or NASH. And so I think for two reasons, one, because the urgency to those patients who have no information about their liver health or this disease that may be progressing within them, you know, they may soon end up in a transplant center or in a liver cancer center. So the urgency for those patients is dire. But I also think in terms of, of persuading other parts of the healthcare system, that NASH is something worth treating, recognizing that it is present in another disease population, another patient population of the disease state, I think will go a long way towards getting a larger buy-in across the medical ecosystem in caring about and caring for NASH. Yeah, I mean, I couldn't agree more, Donna, you said that absolutely perfectly. I couldn't agree more that the people at most risk are those that are in diabetic clinics or people with severe obesity. And really we need to target those for certainly for intervention and treatment. I do think there's a role for sort of global promotion at a governmental level of healthy eating, increased activity, whether it's, you know, school lunch or just programs that incorporate more activity into the school day and things like that, because nobody doesn't benefit from that. And there's improvement in multiple disease states, not just fatty liver disease when you do that. And you as a, as a bonus also prevent liver disease. So I couldn't agree more with what you said, and I'm sure Allison can speak more to that as well. Yes, wholeheartedly agree on all accounts here. You know, screening is the first step. If you don't identify the problem, you can't do anything. And so, you know, we feel really strongly about, you know, and there's a lot of evidence and science to suggest that if we screen children for, and adults, right, for obesity, then, you know, there are interventions that work. There's a ton of science out there. We can make a difference. There are evidence-based interventions that work. And so we have to identify the problems so that we can help people. And of course, prevention is key. I'm a public health person, right? Prevention, prevention, prevention, starting from, you know, in utero all the way through the lifespan. So wholeheartedly agree on all accounts. Thank you. And definitely is, is, is definitely looking at the diabetic population, but also something I want to put in there is that NASH is not, does not necessarily only hit the obese population, that it also hits people who are at optimal weight. And so just to, to, if, if primary care doctors can go ahead and make that as part of their screening, part of the blood tests, especially with the ELF test that just came out, is that would be amazing to be, to go ahead and encourage the use is, is I think that we can find a lot of different beginnings before it progresses any further. You're right, Terri, and actually to, to your point about that, I think that one of the biggest gains and where we could really make strides is if we just increased awareness. I mean, a lot of physicians don't even know what it is, what, what are risk factors might be. And, and, and honestly, it begins with our medical school curriculum. We don't even teach it in medical school. So if we could even begin to do that, then teachers are, you know, the, you know, physicians are, they actually are teachers. We are teachers, you know, and, you know, we'd be able to educate our, our colleagues and our patients and, and, and highlight people who are at risk. Absolutely. You know, every one of these points is outlined in the U.S. NASH action plan, and we are the only country in the world who has a national plan for how to address NASH and an action for each stakeholder group, you know, present here and, and mentioned. And so I think we should absolutely, you know, take advantage of that, of that headstart that we have in having pulled our community together, pulled our stakeholders and medical societies together. And I'll, I'll know, you know, what steps we need to take. We need to do them. And we hope that the NASH care act will absolutely advance our ability to do them. We also hope that it would be a model for other countries. And Dr. Monello is absolutely right. As we, you know, lead a global movement through our international NASH day, it is an opportunity to share with the participation that we've been so honored to have with physicians and patients from so many different countries all over the world, really hungry for this information, hungry for the activation of NASH patients within their borders. And so here's an opportunity for America to lead in, in this area. And so I hope that we will, we will take up that challenge. Well, I want to thank each of our panelists. I want to thank you, Donna, as a co-moderator and Drs. Goodman and Ranella and Terry for their testimony today. I hope that you as the audience, we have been impressed by the importance and the pressing nature of NASH as a public health problem, and that you strongly consider that the NASH care act, which will soon be reintroduced to the Congress, which is involved of course, in the surveillance screening and identification of cases. We don't start anywhere without that, that we hope that, that, that, that your support of the NASH care act allows that critical action to happen in, in the community and for those we care for. Thank you again, everyone. And, and have a great evening. Thank you. Thank you. Thank you.

non-alcoholic steatohepatitis

NASH

fatty deposits

liver disease

early detection

intervention

screening

obesity

diabetes