On November 4th 2021, Global Liver Institute led an Externally Led Patient-Focused Drug Development Meeting on NASH. This GLI led EL-PFDD meeting on NASH provided regulators, and drug developers the invaluable opportunity to hear from patients and caregivers directly about the challenges and burdens of this life-threatening condition.
“…for many NASH patients their house is figuratively on fire and they’re willing to take some risk so you know I’m being repetitive but I feel like I can’t say it enough please consider the patient perspective during your evaluations…” – Tony Villiotti, NASH EL-PFDD Meeting Panelist, and President of NASH kNOWledge.
Participants and panelists emphasized a variety of critical points throughout the meeting, the patient and caregiver survey, and this final report. This includes the lack of adequate educational support, the lack of public awareness, the social, physical, and emotional impact that NASH has on their lives, the lack of a unified approach in early detection and management of NASH, the challenges in managing NASH symptoms, their perspectives on the balance between potential future therapy risks and benefits, the importance of patient-centric endpoints, the challenges in getting diagnosed, their experiences with liver biopsy including the burden associated with and the ineffectiveness of the diagnostic tool, and the need to improve NASH clinical trial design.
“Just this time alone since we started planning this NASH EL-PFDD meeting to the conclusion of this event, there have been patients that have died, there are patients that have progressed from early stages of NASH to more advanced stages, there are patients that have progressed to liver cancer or to needing a liver transplant. The urgency that we all feel as patients and caregivers can not be overstated. If we can make regulatory time a little closer to patient time, that will serve everyone.” – Donna Cryer, NASH EL-PFDD Meeting Moderator, and CEO and Founder of GLI
GLI appreciated the support of the liver advocacy community, and GLI’s Liver Action Network (LAN) on this monumental meeting including Community Liver Alliance, Fatty Liver Alliance, Fatty Liver Foundation, Liver Coalition of San Diego, Liver Health Foundation, Midsouth Liver Alliance, NASH kNOWledge, Northeast Ohio Liver Alliance, and the Texas Liver Foundation.
About Global Liver Institute
Global Liver Institute (GLI) is a 501(c)3 nonprofit organization founded in the belief that liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. Operating globally, GLI is committed to solving the problems that matter to liver patients and equipping advocates to improve the lives of individuals and families impacted by liver disease. Follow GLI on Twitter, Facebook, Instagram, LinkedIn, and YouTube.
Washington, DC – March 7, 2022 – Global Liver Institute (GLI) will convene the fifth International NASH Day (#NASHday) on June 9, 2022 with the theme Stop NASH Now. This year, GLI is pleased to support grassroots efforts from around the globe that will raise awareness and promote diagnosis and care options in ways as unique as each community. Held annually on the second Thursday in June, #NASHDay exists to increase awareness about nonalcoholic steatohepatitis (NASH) among at-risk patients, medical professionals, and the global public health community.
“International NASH Day annually advances the global movement to prevent and treat NASH. It is the premier collaboration of community leaders, healthcare providers, and industry, informed by the patient voice,” stated Donna R. Cryer, JD, president and CEO of GLI. “Across the globe there is an immediate need to relieve the heavy burden that NASH places on every community. It is time to Stop NASH Now.”
GLI has opened applications from non-profit organizations to become 2022 #NASHDay partners and Stop NASH NOW through local outreach or participation in virtual program options. Among a number of benefits, partners will be provided with multilingual NAFLD/NASH educational materials that they may use, and a limited number may receive program-support grants. Learn more about partner benefits and requirements and submit your application by April 15, 2022.
Annually, GLI aligns and advances the global conversation around NASH by convening international panelists of experts on relevant topics, from innovations in non-invasive diagnostics to the connection between NASH and cardiometabolic diseases. However, the strength of #NASHDay each year comes in large part from the action and creativity of each partner organization involved. NASH is the advanced form of nonalcoholic fatty liver disease (NAFLD). Both are closely linked with obesity, and current global estimates show that as many as 25-30% of people have NAFLD and 2–6% have NASH.1 2 While the symptoms of NASH affect patients throughout the world in a similar manner, every community has different values and resources to consider for prevention and treatment. The culturally relevant programming of each #NASHday partner is critical to its impact.
Last year, GLI and its 120 #NASHday partners around the world organized engaging digital events to declare the urgency of combating NASH in their communities. Many organizations sent representatives to speak on local TV or radio talk shows, while some facilitated training days on NASH diagnosis and treatment options and even coordinated mobile clinic visits to neighborhoods. Join advocates from around the globe and become a 2022 #NASHday partner to Stop NASH Now!
Support the NASH Daysocial media campaign using hashtags #NASHday #StopNASHNowPlease direct any additional questions to NASHDay@globalliver.org.
International NASH Day and its logo are registered trademarks of Global Liver Institute.
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About Global Liver Institute
Global Liver Institute (GLI) is a 501(c)3 nonprofit organization founded in the belief that liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. Operating globally, GLI is committed to solving the problems that matter to liver patients and equipping advocates to improve the lives of individuals and families impacted by liver disease. Follow GLI on Twitter, Facebook, Instagram, LinkedIn, and YouTube. GLI is the global host of International NASH Day.
Sources
(1) Estes, C., Razavi, H., Loomba, R., Younossi, Z., & Sanyal, A. J. (2018). Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology (Baltimore, Md.), 67(1), 123–133. https://doi.org/10.1002/hep.29466
(2) Younossi, Z. M., Koenig, A. B., Abdelatif, D., Fazel, Y., Henry, L., & Wymer, M. (2016). Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology (Baltimore, Md.), 64(1), 73–84. https://doi.org/10.1002/hep.28431
GLI’s Liver Action Network Supports World Obesity Day to Acknowledge Strong Connection Between NASH and Obesity
As members of Global Liver Institute’s Liver Action Network (LAN), the undersigned organizations are proud to take part in World Obesity Day, and take action to recognize the bidirectional relationship between many chronic liver diseases like nonalcoholic steatohepatitis (NASH), and obesity. Worldwide, NASH affects more than 148 million people and continues to rise each year.1 Increasing amounts of research have closely linked the presence of NASH to metabolic comorbidities, two of the most common being obesity and diabetes.2 This is why it is imperative that ongoing awareness efforts advocate collaboratively to address these linked conditions holistically rather than through siloed efforts.
Today, the LAN pledges collective support of World Obesity Day to acknowledge the strong connection between NASH and obesity. Celebrated annually on March 4, World Obesity Day is a global movement that corrals attention around the urgent need for awareness, education and policy action aimed at reducing the prevalence of obesity. The need for action has never been greater as the worldwide burden of obesity could affect upwards of 1 billion people by 2025, subsequently increasing the number of individuals at risk for developing NASH.3
As representatives of the liver advocacy community, we stand alongside the entire obesity advocacy community in recognizing obesity as a serious condition, and as a severe metabolic risk factor for NASH. We set forth the following recommendations to reduce overall burden of NASH and obesity collectively:
Worldwide prevalence of obesity among diagnosed NASH patients can range as high as 81%.5 Therefore, we also strongly support increased support of obesity preventative measures and public health programs at local, national, and global levels.
Due to NASH’s strong link to obesity, a 7-10% weight loss is understood as the threshold needed to induce the highest rates of NASH resolution and fibrosis regression.4 However, weight loss is extremely difficult to accomplish and sustain. This is why globally we strongly support increased access to available safe and effective obesity treatment options like anti-obesity medications. Specifically, in the United States, we
support Food and Drug Administration (FDA) approved anti-obesity medications and urge the Centers for Medicare & Medicaid Services (CMS) and the Biden administration to include Medicare Part D coverage for these medications.
This coalition stands ready to partner with other like-minded initiatives in the areas of NASH, obesity and diabetes to amplify the message of the correlation between these conditions. We look forward to the future and ensuring individuals affected by liver diseases are not left alone.
Liver Action Network Members: Global Liver Institute Community Liver Alliance Fatty Liver Alliance Fatty Liver Foundation Liver Coalition of San Diego Liver Health Foundation Midsouth Liver Alliance NASH kNOWledge Northeast Ohio Liver Alliance Texas Liver Foundation Empire Liver Foundation
(Washington, D.C., March 2, 2022) – Global Liver Institute (GLI) proudly announces the expansion of the Liver Action Network (LAN) to include a partnership with Empire Liver Foundation. Based in New York City, this transformative organization provides clinical training to healthcare professionals on how to screen and treat patients with Hepatitis B & C in a variety of clinical settings. “Empire Liver Foundation is honored to join the Liver Action Network. Our missions are aligned to improve the lives of individuals impacted by liver disease through education and awareness. We look forward to collaborating together through our shared expertise and resources.” said Douglas Dieterich, M.D., President of Empire Liver Foundation. The impact of this addition is significant as New York City is now represented within the LAN, allowing for greater opportunity in actively shaping liver policy in the United States’ most populated city.
Empire Liver Foundation was established by some of the most prominent liver specialists in the world, including Dr. Hillel Tobias, who served as founding board member to GLI as well as Board Chair. GLI looks forward to continuing collaborations with Dr. Tobias through Empire Liver Foundation. “This partnership with Empire Liver Foundation will be instrumental in reaching the greater New York area and underscores the power that providers, patient advocates, and advocacy organizations have when collaborating together to shape policy across the entire liver disease community,” said Donna Cryer, J.D., GLI President and CEO.
In 2020, GLI launched the LAN to meet the needs of a rapidly growing cadre of liver health advocates, capitalize on the eagerness of the liver community to be active, and address the needs/opportunities of the community. Since then, the LAN has grown to consist of 12 community liver advocacy organizations, representing over 40 U.S. states and 2 countries. We are pleased to welcome Empire Liver Foundation as the 12th organization to join this rapidly growing network capable of making a worldwide mark on liver disease advocacy. “This addition to the LAN strengthens our current reach and scope within the United States and Canada by corralling community based liver organizations at the local level.” said Scott Suckow, LAN Chairperson.
We look forward to continued growth of the LAN in 2022 with goals to have representation in every state in the US as well as growing the network’s global footprint outside of the US to ensure that advocates all over the world have the opportunity to advance liver policy. To learn more about the LAN, or to join please visit https://globalliver.salsalabs.org/signuptoday/index.html.
About Global Liver Institute
Global Liver Institute (GLI) was built to solve the problems that matter to liver patients, equipping advocates to improve the lives of individuals and families impacted by liver disease. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. GLI believes liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI is the only patient-created, patient-driven nonprofit liver health organization operating globally. Follow GLI on Twitter, Facebook, Instagram, LinkedIn, and YouTube.
About Liver Action Network
The organizational members include: Global Liver Institute, Fatty Liver Alliance, NASH kNOWledge, Texas Liver Foundation, Northeast Ohio Liver Alliance, Mid South Liver Alliance, Fatty Liver Foundation, Community Liver Alliance, Liver Health Foundation, Liver Coalition of San Diego, HepCURE, and Empire Liver Foundation.
(Washington, DC, Wednesday, February 16, 2022)—Today, Global Liver Institute (GLI) applauds the confirmation of the new Food and Drug Administration (FDA) Commissioner Dr. Robert Califf.
On Tuesday, February 15, the United States Senate confirmed Dr. Robert Califf to lead the Food and Drug Administration (FDA) in a 50-46 vote. For the last 13 months there has been a critical gap in permanent leadership at the FDA. During this extended break, especially during a global pandemic, we greatly appreciate Acting Commissioner Dr. Janet Woodcock’s guidance and service. However, without permanent and stable leadership, the FDA has been hampered in its ability to foster scientific excellence and protect the public health by assuring the safety, efficacy and security of medical therapies.
Life threatening liver conditions continue to be under recognized, under diagnosed, and under treated. As leaders of the liver patient advocacy community, we depend upon a stable regulator, and need a FDA Commissioner that will be immediately empowered to accelerate patient centric regulatory actions. This is why we applaud the confirmation of Dr. Robert Califf as the new FDA Commissioner.
Not only will his previous experience as the FDA Commissioner from 2015-2017 allow him to hit the ground running, he has consistently demonstrated a commitment to making patient-oriented decisions. Throughout his career has exhibited an understanding of the importance of shared expectations, and reliability between the FDA and the patient community. Most importantly, he recognizes the importance of advancing patient-focused goals in treatments and therapies for liver patients.
Over the last few months, we greatly appreciate the FDA’s willingness to work collaboratively on a variety of initiatives including our NASH, and PBC EL-PFDD meetings. We extend our strongest support for those entrusted to conduct scientific research, advance regulatory science, and approve new safe and effective therapies. With a new FDA Commissioner, we look forward to continuing our strong partnership, and advancing liver patient centric policies.
About Global Liver Institute
Global Liver Institute (GLI) is a 501(c)3 nonprofit organization founded in the belief that liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. Operating globally, GLI is committed to solving the problems that matter to liver patients and equipping advocates to improve the lives of individuals and families impacted by liver disease. Follow GLI on Twitter, Facebook, Instagram, LinkedIn, and YouTube.
Transforming the Public Consciousness with Conversations for and about the Rare Liver Disease Community
WASHINGTON, DC, FEBRUARY 1, 2022 – Global Liver Institute (GLI), a patient-led liver health nonprofit operating globally, is proud to announce today the launch of its second annual Rare Liver Diseases Month as part of its mission to improve the lives of individuals and families impacted by liver disease. The campaign, themed #RareAware, will feature an array of activities throughout February, including education, self-care, patient empowerment, and vital awareness-raising events for several rare liver diseases.
GLI President and CEO, Donna R. Cryer, JD, understands firsthand the daunting challenges of being diagnosed and living with a rare liver disease while being a 27-year transplant recipient. Mrs. Cryer said, “As someone who has lived with the ongoing challenges of an autoimmune liver disease for over 30 years, it is of personal significance to me for GLI to once again present a high-impact, month-long campaign that will continue to draw much needed attention and bring transformative change to the rare liver disease community. As the convener of the largest alliance of organizations devoted to addressing the challenges of pediatric and rare liver disease patients, GLI is deeply committed to addressing unmet needs and collaborating with our Pediatric and Rare Liver Diseases Council Members and partners to spur policy changes and design comprehensive, creative, and thoughtful solutions to issues faced on a daily basis – often for years on end – by our rare liver patients and their caregivers and support systems.”
In alignment with the International Rare Disease Day movement, the #RareAware campaign draws attention and creates resources for people living with rare liver disease. Although there are over 100 liver diseases, the majority are often overshadowed by the few most common liver diseases. Successful research and development of treatment for pediatric and rare liver diseases lags far behind that of more common liver diseases, and some medical professionals continue to lack basic knowledge to be able to effectively identify, diagnose, and treat rare liver diseases. GLI’s #RareAware campaign will highlight patient stories, support patients needs, and advocate for policy changes that will benefit the rare liver disease community, with a full month of events and conversations leading up to International Rare Disease Day on February 28.
While not part of the #RareAware campaign, GLI kicks off the month of activities with an opportunity to listen directly to patients and providers about the real world burden of a serious rare liver condition through an Externally-Led Patient Focused Drug Development Meeting (EL-PFDD) on Primary Biliary Cholangitis (PBC) on February 4. Following the PBC EL-PFDD meeting, the campaign will incorporate policy events for all those affected by rare liver disease, including leading a “Living with Rare Liver Disease in Europe ” event on February 18 and a U.S. Congressional Briefing on February 25. Weekly activities include social media takeovers by patients, introductions to self-care and wellness tools as part of GLI Living, and a spotlight on rare liver disease during GLI LIVE, the weekly virtual show hosted by Mrs. Cryer as she engages in enlightening and informative conversations with patients, physicians, and other leaders working with rare liver diseases.
To encourage extraordinary young people facing and living with rare liver disease, GLI will host weekly conversations with Evren & Kara Ayik, the co-authors of Extraordinary! A Book for Children with Rare Diseases, and the mother-son team with first-hand ultra-rare disease experience. These Extraordinary Young People events will offer the young people facing rare liver disease an opportunity to discuss identity, recognize positive impacts of their rare disease, and connect with their peers. Read more about the book here.
Nicole Wells, who is both a rare liver disease patient and GLI’s Pediatric and Rare Program Manager, personally understands the pressing need for awareness. “We welcome everyone to join the conversation around rare liver diseases. Whether rare liver disease has impacted your life first-hand or you have been inspired by the stories of patients and caregivers, I invite you to use your voice to support rare liver disease patients this February and every month. The #RareAware Advocate Toolkit on GLI’s website provides several ways to get involved,” Ms. Wells said.
International Rare Disease Day itself is officially recognized on the rarest of all days: February 29, which occurs only during leap years. However, mirroring the experience of many rare disease patients, Leap Day is represented by a surrogate day (February 28) this year and most others. The day aims to raise awareness and generate change for the 300 million people worldwide – approximately the population of the United States of America – living with rare diseases, their families, and their caretakers.
In addition to the physical, psychosocial, and financial challenges associated with any liver disease, a rare liver disease patient can face additional burdens such as a lengthy, often invasive diagnosis, formidable travel distance to see a hepatologist, and, if even available, costly treatments. These rare diseases often manifest early in life as cumbersome obstacles to normal growth and development in childhood. This is additionally complicated by the fact that many rare diseases have geographic factors, meaning each nation bears the burden of rare diseases in its own way. Despite these challenges, innovative regulatory and reimbursement models being developed as the rare disease space matures have led to increased investment, data collection/sharing, and clinical collaborations focused on rare diseases.
Rapid advancements to policy and committees welcomed in the new year. One of the most highlighted actions was the advancement of the nomination of Dr. Robert Califf as the incoming commissioner of the FDA to the full U.S. Senate. GLI and the patient advocacy community depend upon a reliable regulator that understands the importance of patient representation, and inclusion throughout the drug development process. We support the eventual selection of a new FDA commissioner that shares these values. With this in mind, GLI and GLI’s Liver Action Network (LAN) submitted a letter of support to U.S. Senators Patty Murray and Richard Burr, the Chair and Ranking Member on the Committee on Health, Education, Labor and Pensions in support of Dr. Califf’s nomination. His extensive experience collaborating with patients equips him with the knowledge and tools to address the diverse influencing factors that can impact liver disease such as obesity, COVID-19, and substance use disorders.
He was the former FDA commissioner previously in 2016 under the Obama administration. Dr. Califf’s work as a cardiologist and biotechnology consultant gained him extensive research experience on clinical trial design and established partnerships with the pharmaceutical industry. The incoming commissioner faces profound challenges concerning the future of the pandemic given that rapid COVID-19 tests regulated by FDA are expensive and hard to find. However, Dr. Califf is not given sufficient credit for his commitment to patients and the patient advocacy community. His support for the People-Centered Research Foundation strengthened the ability of patients and patient advocates to partner with researchers across the People-Centered Research Institute’s PCORnet. Dr. Califf has demonstrated throughout his career that he would ensure the FDA continues its expansion of these vital initiatives.
In order to advance liver health, partnership with regulatory bodies such as the FDA is vital due to the diverse nature of liver cancers, rare liver diseases, and chronic liver diseases. The absence of leadership in the FDA has left a gap in making significant progress to offer new and innovative treatments for liver health patients most in need. GLI and GLI’s Liver Action Network are encouraged to see the nomination of Dr. Califf to the full Senate. We look forward to the filled Commissioner role that will offer the FDA more stability, and progress forward in placing patient needs at the forefront of medical treatment development and research.
Donna R. Cryer, JD
President & CEO Global Liver Institute
OPEN ADVOCACY OPPORTUNITIES
Register Today for the DDNC’s 32nd Annual Public Policy Forum
The DDNC Spring Public Policy Forum, held virtually this year from March 6th to March 8th, is an advocacy conference that brings together patient advocates, health care providers, and industry representatives from the major national voluntary and professional societies concerned with digestive diseases. This year’s theme is “Putting Patients First”, and over the course of this event, attendees will hear from multiple panels of leaders in the digestive disease community, learn about the key legislative issues impacting digestive disease patients, and advocate for digestive disease research and improved patient care in virtual meetings with Capitol Hill congressional offices.
To register for the Public Policy Forum today, please fill out the registration form here.
GLI POLICY DEVELOPMENTS
Register for GLI Primary Biliary Cholangitis (PBC) Externally-Led Patient-Focused Drug Development (EL-PFDD) Meeting
An EL-PFDD meeting of this magnitude will allow the U.S. Food and Drug Administration (FDA) and other stakeholders across the medical field to obtain a wide range of patients’ and caregivers’ input on PBC including their perspectives on their condition, its impact on daily life, and the urgency around developing therapies. Global Liver Institute will lead an Externally-Led Patient-Focused Drug Development Meeting (EL-PFDD) on Primary Biliary Cholangitis (PBC).
This online event is scheduled for February 4, 2022 and is open to the public with registration required. Register here.
This past month, the National Institute of Diabetes and Digestive and Kidney Diseases released their final strategic plan. The strategic plan presents a broad vision for accelerating research over the next 5 years to improve the health of people who have or are at risk for diseases within its mission: diabetes and other endocrine and metabolic diseases; liver, intestinal, and other digestive diseases; nutritional disorders; obesity; and kidney, urologic, and hematologic diseases. The Strategic Plan is based on extensive input from leading researchers and patient advocates, including GLI and GLI’s LAN, across the country.
Coming to grips with the risk of dying from liver disease is the key to learning to live with liver disease. If you know someone who might benefit from learning about us or who you think might be supportive please feel free to forward this to them. Here are some links to information that might be of value as an introduction to the foundation:
Wayne Eskridge of the Fatty Liver Foundation was a recent guest on the Surfing the NASH Tsunami podcast and spoke about the SUNN (Screening for Undiagnosed NAFLD and NASH) Study. Podcast episode linked here.
The Fatty Liver Foundation SUNN study report is now published and live on PLOS ONE. Read it here.
The Fatty Liver Foundation launched a public-private partnership fund with the long-term goal of screening a million asymptomatic, undiagnosed individuals a year for nonalcoholic fatty liver disease (NAFLD).
Liver Health Foundation
Webinar: Liver Cancer, Hepatocellular Carcinoma (HCC), and Cholangiocarcinoma
When: February 23, 2022
Time: 5:30-6:30 PT
This webinar will offer crucial facts about liver cancer, its multiple and various causes in adults and children, available treatments including medication and transplantation, guide for prevention of liver cancer, and points on surviving liver cancer. Knowledgeable hepatologists and oncologists will touch upon the risk factors and at-risk individuals and will offer updated guidance on liver health. Pre-registration is required here.
Mid-South Liver Alliance
Mid-South Liver Alliance will be holding a ‘Walk With Me’ campaign in collaboration with a new initiative called Lifestyle Changes in the South. This event will begin March 1, 2022 and the goal is to promote a more physically active lifestyle in the southeastern US. More information will be shared soon on their website: https://midsouthliveralliance.org/.
Register for RDLA Virtual Rare Disease Week on Capitol Hill – February 22-March 2, 2022
Rare Disease Week on Capitol Hill brings together rare disease community members from across the country to be educated on federal legislative issues, meet other advocates, and share their unique stories with legislators.
No prior experience is necessary. Registration for this event and all RDLA events are free for all rare disease advocates. Register here.
Fatty liver disease (FLD) and nonalcoholic steatohepatitis (NASH) are increasing in prevalence worldwide, creating a major global public health crisis. To adequately educate patients, practitioners, and policymakers, there is a need to collect, curate and share relevant information. NASH News, published on behalf of the Global Liver Institute’s NASH Council, intends to meet that need and to facilitate collaboration across the emerging NASH community on a monthly basis.
We would appreciate your feedback and content contributions. Please contact nash@globalliver.org
I had the opportunity to participate in the NASH-TAG 2022 Conference in Park City, Utah. Thank you to course directors Michael Charlton, MBBS, FRCP; Vlad Ratziu, MD; Stephen Harrison, MD, and Rohit Loomba, MD, MHSc for setting a standard for high-quality scientific presentations, and even higher expectation and tone for collaboration and innovative thinking.
As a liver patient involved in the field professionally in clinical trial recruitment, regulatory affairs, and health system innovation for two decades here are my takeaways:
We have an opportunity to reset in 2022. Take the lessons learned, good and bad, in drug development and choose what we will do from this point forward.
Biopsy is misapplied to this disease (or set of diseases). Should patients be expected to take a test we cannot accurately, dependably interpret? Artificial intelligence (AI) will help, but we should be brave enough to address the foundational issue.
Focus on endpoints that are achievable and have meaning to patients, such as non-progression (which has models in other liver diseases like primary sclerosing cholangitis (PSC)
Secure commitment from our regulatory partners when we meet the agreed upon endpoints that will be sufficient for approval.
Standardize the standard of care for placebo groups.
Let’s not gloss over what we know does work – 7-10% weight loss – and continue both research in those therapies that induce that level of weight loss and facilitate patient access to all methods, services, and treatments.
Take action in the timeframe that reflects the urgency of patients; hundreds of whom are progressing to cirrhosis, cancer, and transplant every day.
Donna R. Cryer, JD President & CEO Global Liver Institute
GLI News
Global Liver Institute and TriSalus Life Sciences Partner To Launch “Liver Central,” a New Resource Hub for Liver Cancer Researchers, Clinicians and Patients
The Global Liver Institute (GLI), the only patient-led liver health nonprofit operating internationally, in partnership with TriSalus Life Sciences®, an immunotherapy company on a mission to extend and improve the lives of patients living with liver and pancreatic tumors, announced the launch of Liver Central, a comprehensive online guide for all things related to liver cancer. Learn more about the educational resources offered through Liver Central at livercentral.org.
Become a Partner or Sponsor for International NASH Day – June 9, 2022
Global Liver Institute (GLI) is pleased to announce that the 2022 International NASH Day (#NASHday) will be held on June 9, 2022! Please join us in a global effort to raise awareness about NASH and the actions that people can take to address this life-threatening disease worldwide. Last year, we transformed #NASHday into an engaging multi-platform experience, convening 120 IND partners from 73 countries and 33 remarkable international speakers to declare the urgency of combating the parallel epidemics of NASH and COVID-19. Contact NASH@globalliver.org for more information. View the 2021 NASH Day Summary Report
Surfing the NASH Tsunami
Every week, a global community of fatty liver disease stakeholders comes together to explore the most important challenges in diagnosing, treating, and developing medications for patients. Catch the latest episode of Surfing the NASH Tsunami featuring commentary from GLI Founder and CEO, Donna Cryer, on Day 1 of the recent NASH-TAG Conference 2022, held January 6-8.
GLI LIVE
Join GLI President and CEO, Donna Cryer in conversation with world experts in policy, research, clinical care, and wellness as they put liver patients and the challenges they face front and center. Join GLI LIVE with your questions on Facebook, Twitter, or GLI’s YouTube channel every Wednesday at 12 PM ET.
Upcoming GLI Events
February 3: NASH Council Policy Working Group. Contact Andrew Scott for more information February 4: PBC Externally-Led Patient-Focused Drug Development Symposium. Contact Andrew Scott for more information March 3: NASH Council Policy Working Group. Contact Andrew Scott for more information May TBD: NASH Council Meeting. Contact Jeff McIntyre for more information June 9:International NASH Day. Contact NASH@globalliver.org for more information
Patient Perspective
How do people learn they have NASH?
The excerpt below is taken from a patient story featured on our International NASH Day website. Read the patient’s full story.
“I was diagnosed with NASH by me being my own advocate. I felt something was not right. I was having symptoms and every test was coming back normal except my liver enzymes . I was bloating so bad I looked six months pregnant and had a constant pain from under my right rib cage that I now felt in my back. I was diagnosed with fatty liver 20 years ago and always told it’s common…Eat healthy and exercise, that(s) all you can do (I was told). I was frustrated by that point and demanded a biopsy.
At that time, I was down 50lbs and walked 5 miles a day and on Sundays hiking 10 to 15 miles. Yes, I was still overweight but in my best health… The very first time I heard clean diet and no more than two lbs of weight loss per week. 20 years of all kinds of fad diets and eating prepackaged foods, not once have I been informed (of) the importance of a clean diet until that day. I walked away educated for the first time.I thought, great, I’m better, I must have reversed it.”
Madrigal Pharmaceuticals GLI is pleased to welcome Madrigal Pharmaceuticals as one of the newest members of the GLI NASH Council. Madrigal Pharmaceuticals, is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver. The company has advanced its lead candidate, resmetirom, (also known as MGL-3196) through Phase 2 clinical trials in NASH and are expecting it to demonstrate multiple benefits across the broad spectrum of NASH and NAFLD patients.
Research & Development
Can Non-Invasive Medical Devices Help Speed Intervention in Liver Disease? Studies show that detecting and monitoring liver disease using vibration-controlled transient elastography (VCTE) is a non-invasive, convenient, and cost-effective way for clinicians to quantify the stiffness of liver tissue and to estimate liver fat at the point of care. VCTE also offers consistent results to enable clinics to monitor fatty liver disease and provide feedback to patients about their diet and lifestyle modifications. Read more
GLI NASH Resources
NAFLD/NASH: How Can Patients Participate in Clinical Trials GLI recently released a guide to participating in clinical trials for patients with NAFLD/NASH. NAFLD/NASH: How Can Patients Participate in Clinical Trials is a comprehensive resource that provides answers to your questions about clinical trials for NAFLD/NASH patients and caregivers – what they are, why they are important, questions to ask, and where to find them. Coming soon in French and Spanish.
2021 U.S. NASH Action Plan Scorecard This year-end scorecard lists the accomplishments achieved according to the detailed agenda in the U.S. NASH Action Plan for each relevant stakeholder group — patients/carepartners, clinicians, medical societies, patient advocacy organizations, industry, payors, health systems, regulators, and policymakers. While gaps and challenges remain, tracking and acknowledging NASH successes according to the U.S. NASH Action Plan is pivotal for the field to respond on a national scale in 2022 and beyond.
U.S. NASH Action Plan GLI and the GLI NASH Council released the U.S. NASH Action Plan to comprehensively address NASH and its impact on patients and families, public health, and the economy. It includes a set of actionable recommendations for the full spectrum of groups involved in NASH prevention and treatment.
NASH Core Curriculum: A Comprehensive Online Resource Center
GLI, in collaboration with Clinical Care Options, launched the CME course, NASH Core Curriculum: A Comprehensive Online Resource Center to improve clinician understanding of foundational concepts in NASH diagnosis, management, and emerging pharmacologic treatment strategies. Resources are developed primarily for clinicians, including advanced practice clinicians, in hepatology, gastroenterology, endocrinology, and primary care. The full curriculum includes CME/CE-certified video modules, ClinicalThought™ expert commentaries, and downloadable presentations and resources. NASH Core Curriculum is supported by educational grants from Gilead Sciences and Novo Nordisk Inc.
GLI Nutrition App with NutriStyle
GLI and NutriStyle Inc. have partnered to create a personalized nutrition app for people living with liver disease, diabetes, and other chronic conditions or who want to maintain good liver health. The app will create personalized meal plans to meet the specific requirements set out by GLI nutritional advisors for people with NASH or a general interest in liver health. Visit NutriStyle to learn more.
Reaching At-Risk Patients Through COVID-19 Vaccination Sites
GLI launched a collaborative effort with Summit Clinical Research to promote NASH awareness in the context of liver health and COVID vaccination via partnerships through city vaccination sites and direct patient education. Providers will be giving people who have just received their COVID-19 vaccination our new resource, After Your COVID-19 Vaccination, Take the Next Step for Your Liver. Please contact NASH@globalliver.org if you would like to share this resource through a COVID-19 vaccination site.
Clinical Care
Millions are suffering from diet-related diseases. What number will make us pay attention?
A recent analysis from the Rockefeller Foundation on “The True Cost of Food” said the nation spends $1.1 trillion on food, and loses another $1.1 trillion in health-care spending and lost productivity attributable to diet-related diseases. Read the article
Educational Interventions Are Needed to Address Knowledge Gaps for Management of NASH
While hepatologists and other specialists make most NASH diagnoses and are the primary care coordinators, there is a need for educational interventions to address knowledge gaps. Read more about the two posters presented at The Liver Meeting Digital Experience (TLMdx) addressing areas of unmet need among specialists.
More Seniors Need Liver Transplants, Often Due to NASH
A new study has revealed that the proportion of older people requiring a liver transplant has greatly increased, likely due to the concurrent rise in NASH. “In the past, older patients were routinely denied listing for liver transplantation because doctors believed they were less likely to survive the surgery and post-transplant management…age limits are largely being abandoned as exclusion criteria.” Maria Stepanova, PhD, Center for Outcomes Research in Liver Diseases, said in a press release.
Current Clinical Trials
Clinical trials are at the heart of all medical advances. The goal of clinical trials is to determine if a new test or treatment works and is safe as well as other aspects of care, such as improving the quality of life for people with NAFLD or NASH. Since there are currently no medications approved for the treatment of NAFLD or NASH, clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.
As we enter a third calendar year marked by COVID-19, the Omicron variant has caused pandemic peaks in cases and hospitalizations. However, we also have a greater understanding of the disease–and more tools at hand–than ever before. You may feel inundated with updated guidelines, variable supplies, and newly approved drugs. We have prepared five practical tips below to help you safely navigate life in 2022.
Preventing COVID-19 Infection
1. Staying Diligent with Good Hygiene
Tiresome but effective, these precautions make a difference in keeping yourself, your household, and your community safe and healthy.
Avoid crowds and poorly ventilated spaces.
Social distance, staying 6 feet away from someone outside the home or someone sick in your home.
Wash your hands often with soap and water: before eating or drinking, after leaving a public place, after blowing your nose, coughing, or sneezing, etc. Use hand sanitizer when soap and water are not available.
After a COVID-19 exposure, whenever you cannot socially distance, or as required locally, continue to wear a high-quality, well-fitted mask.
2. Masking Up: Updated Guidelines for Your Best Protection
It is due time to replace the stopgap measures we implemented early in the pandemic: Handmade masks, thin cloth masks, and ill-fitting masks. Fabric pores are about 5x larger than most droplets, rendering them several times less effective than a surgical mask, filtered mask, or respirator. The following list provides more information about each of the mask types currently available. The number indicates the minimum percentage of airborne particles that a mask must filter out to achieve this rating.
N95 Respirators: Made to the U.S. National Institute for Occupational Safety and Health (NIOSH) specifications (often considered most stringent), this respiration protection filters out at least 95% of airborne particles for its user.The Biden administration plans to send 400 million N95 face masks to give out free through pharmacies and community health centers, part of an effort to increase access to high-quality masks to control the spread of COVID-19.The government will ship masks from its stockpile starting at the end of the week of January 17.The masks will be available through pharmacies in the federal retail pharmacy program — which includes major grocery stores and retail pharmacy chains.
Though not NIOSH-approved, the CDC keeps a list of overseas products and their performance in a modified NIOSH N95 test. Despite less stringent requirements for these masks, they are still a steep upgrade from a single-ply (or even two-ply) cotton mask.
KN95 Masks: These masks are considered comparable to N95s based on similar Chinese specifications; they have a tent-like shape that is conducive for breathing. They are often available at a lower price point than N95 respirators.
KF94 Masks: Similar to the KN95 masks, these Korean-made masks have a distinct rounded shape that provides room for breathing.
Surgical Masks: While less stylish than a cloth mask, the three-ply design features specifically designed material to reduce the droplets you both expel and inhale.
Be sure to get the most out of your mask with the following tips!
Make sure the mask is snug over your nose, mouth, and chin with no gaps. Don’t modify your mask in a manner that leaves openings.
Wash or sanitize your hands before and after putting on, taking off, or touching your mask.
Dispose of a mask (or set it aside to wash) if it becomes wet, soiled, or otherwise contaminated
To reuse an N95, KN95, or KF94, put it in a breathable paper bag for 3-4 days uninterrupted to let any viruses on its surface die.
Don’t use cleaning products on a disposable mask, as these may damage the fibers or electrical charge designed to trap droplet
If you feel enclosed or restricted while wearing a mask, practice wearing your mask at home with box breathing or simply during everyday activities to gain familiarity with the sensation
3. Staying Up-to-Date with Vaccination
If you haven’t already, schedule and receive the full schedule of mRNA COVID-19 vaccinations (produced by Moderna and Pfizer-BioNTech). Vaccination is now available for ages 5 and up. Review the following article for up-to-date information about age groups, dosage, and effectiveness.
Schedule and receive additional doses in accordance with the CDC guidelines. Note that this now includes a booster shot for immunocompromised people 5 months after their additional shot–this would be your fourth COVID-19 shot, if you received an mRNA vaccine. New research backs up this recommendation.
The definition of “fully vaccinated” is beginning to shift to include a booster shot in some academic institutions and workplaces; be prepared to comply with this changing understanding.
Be sure to schedule and receive a seasonal flu shot to avoid weakening your immune system with a combined infection. You can get both a flu shot and a covid vaccine on the same day. Have the provider inject in different arms.
Preventive Antibody Treatment
For those who are immunocompromised, there is an extra line of defense available against infection with COVID-19.
AstraZeneca’s Evusheld antibody combination received emergency authorization in December 2021 for pre-exposure prevention of COVID-19 infection for people who are moderately to severely immunocompromised.
The antibody combination has been shown in trials to halve the risk of severe infection or death and protects individuals from infection for at least six months.
Evusheld maintains its potency against the Omicron variant of the virus.
120,000 doses of the treatment have been purchased by the United States to be available throughout the states and territories.
Talk to your PCP to see if you are eligible to receive treatment with Evusheld.
Identifying a COVID-19 Infection
4. COVID-19 Testing
Three days after a confirmed exposure to COVID-19, if you develop symptoms, or after a high-risk event, it is best to take a COVID-19 test.
Start by being proactive: keep a few rapid antigen tests per member of your household on hand in case of an exposure or onset of symptoms.
Every household in the U.S. will be able to order 4 at-home COVID-19 tests for free starting on January 18 at https://special.usps.com/testkits.
As of January 15, health insurers in the US will cover the cost of up to 8 home COVID-19 tests per person, per month. Per CMS, depending on your insurance, you may not have to pay at the point of sale; if you do pay, you should save your receipt and submit a claim to your insurance company for reimbursement.
Current effective options include Abbot’s BinaxNOW test and the iHealth COVID-19 Antigen Rapid Test. Check if your public library has a supply or antigen tests, and set up an online product availability tracker to stay up to date on stock at stores in your area. You may be limited to 1-2 boxes per person.
If you suspect that you or a member of your household has contracted COVID-19 due to exposure or symptoms, start at home with a home test. If a system is in place, report your results to the local public health authority.
If symptoms persist despite a negative test or if you receive inconclusive results, call your PCP or book an appointment for a PCR test at a local testing facility.
Do not go immediately to the local hospital, clinic, or urgent care for testing, as these locations are not optimized for testing capacity and are facing high volumes of patients for other treatment. Find a walk-in testing center or book an appointment.
If you test positive, monitor your symptoms and stay in contact with your PCP to determine if and when you should go to the clinic or head to the hospital. Keep a thermometer and pulse oximeter at home so you can monitor your temperature and oxygen levels, respectively.
Treating a COVID-19 Infection
5. Available Treatments
If you find yourself looking at a positive result, take a breath and try not to panic. We now have effective treatments available if you are at risk of severe symptoms.
Monoclonal Antibody Treatment
Monoclonal antibody (mAb) treatments have been shown to be highly effective in helping keep high-risk people out of the hospital.
Though several mAb treatments have been developed and used effectively throughout the pandemic, only one has shown to work against an infection by the globally dominant omicron variant: GlaxoSmithKline and Vir’s sotrovimab. It is also reported to be effective against all other variants of concern to date.
Supply is limited, so talk to your healthcare providers early to see if you are eligible for this treatment and if there is any available to you.
The U.S. has recently purchased 600,000 doses of sotrovimab to be distributed in the first three months of 2022, with 1.7 million doses shipping worldwide.
Oral Drug Treatment
Pfizer’s oral treatment, Paxlovid, has been authorized for ages 12 and up and serves as a highly effective defense against severe illness from infection.
If you are at risk of severe illness and develop symptoms, act quickly. You will need a positive COVID-19 test and a prescription from your healthcare provider, all no more than 5 days after the onset of symptoms, to receive this treatment.
Pfizer plans to produce 120 million courses of Paxlovid this year, to be sold to countries around the globe.
Paxlovid cannot be taken with certain medications, including a commonly used statin. Work with your PCP to identify any potential drug interactions and figure out the best option for you.
What’s necessary, moving forward?
The world has worked to develop tools that are effective against COVID-19. As we move forward, it is time to scale production of these resources to reduce shortages and ensure everyone has what they need:
Strong communication and guidance about the benefit of an additional booster dose for the immunocompromised; Integration into EHRs and care alerts
Affordable, available, and convenient rapid testing
Increased supply of GSK and Vir’s sotrovimab mAb treatment, in short supply at hospitals
Increased supply of Pfizer’s oral drug, also in short supply at hospitals
Affordable access to high-quality masks for the general public and frontline workers alike
Washington, DC, January 14, 2022 – In 2021, the Global Liver Institute (GLI) formed the Liver Action Network (LAN) to better synchronize engagement across the liver advocacy community, and to meet the needs of a rapidly growing cadre of liver health advocates. The LAN operates as a first-of-its-kind network that provides community member organizations a central structure for the formulation of collective health policy and programmatic solutions.
Today, GLI is proud to announce two new additions to the LAN leadership team so that this growing network can continue to carry out it’s impactful mission of improving the lives of all people impacted by liver disease at the local, state, national and global levels.
Scott Suckow of the Liver Coalition of San Diego and the Northeast Ohio Liver Alliance, has accepted the position as the first LAN Chairperson. Scott has a wealth of experience in alliance development, community building, government relations, association management, strategic program design and execution. As the new Chair of the LAN, Scott will work with GLI staff to ensure the LAN continues to prioritize collaboration, and results driven community initiative development.
Also joining the leadership team is Elisabeth Vogel, serving as the LAN Senior Coordinator. She was previously with GLI’s Liver Cancers Department, and is excited to utilize her Liver Cancers Council experience to provide programmatic solution support to LAN members, and to manage the continued growth of the LAN.
GLI looks forward to continuing to facilitate a group capable of making groundbreaking liver health changes globally. To learn more about the Liver Action Network or to join, please visit https://globalliver.org/liver-action-network/.
