WASHINGTON, DC and DENVER, JANUARY 6, 2021 – 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, today announced the launch of Liver Central, a comprehensive online guide for all things related to liver cancer.
Liver Central provides a central location for those seeking educational materials about the liver and liver cancers, including treatment options and ongoing clinical trials. With founding support from TriSalus Life Sciences, GLI developed this new resource to fill a significant gap in the availability of educational resources and tools. Liver Central will be regularly updated with the latest information on the central role the liver plays in overall health, immunological pathways that impact liver tumor progression and resistance to therapies, as well as treatment approaches and guidelines for various types of liver cancer.
“The growing burden of liver cancer is deeply concerning as more patients hear the words ‘you have liver cancer’ and are left with few treatment options. LiverCentral.org is designed to raise awareness of this vital organ and provide answers for patients and clinicians looking for information and new approaches to treat this devastating disease,” said Donna Cryer, founder and CEO of the Global Liver Institute, and a 27-year liver transplant recipient.
“Our hope is that Liver Central will serve as an enduring educational resource to support patients, clinicians and researchers along the cancer care continuum,” said Steven C. Katz, MD, FACS, chief medical officer at TriSalus. “We want to raise awareness as to how unique the liver is in general, and with respect to how liver immune function creates therapeutic challenges for cancer patients. As we work to bring multi-modality approaches to better address these challenges and ensure more patients can benefit from the promise of immunotherapy, we are grateful for the opportunity to partner with GLI to develop this resource and advance care for patients living with liver tumors.”
In a recent discussion on GLI LIVE, GLI’s weekly educational program that provides tailored information for patients living with liver diseases on a variety of timely topics, Dr. Katz and Ms. Cryer highlighted Liver Central’s functionality for experienced and new patients alike. During their discussion, they spoke at length about the critical need to reinvent liver cancer education, tailor therapeutic approaches based on the unique biology of the liver, and how a central hub of information can bring about positive change in a patient’s experience with liver cancer.
Over the last several decades the percentage of Americans who develop liver cancer has grown. Liver cancer is among the leading causes of cancer death worldwide with more than 800,000 people diagnosed annually.1 Additionally, the liver is one of the most common sites of metastatic cancer. Liver metastases – not the primary cancer – are often the cause of mortality. In fact, for colorectal cancer patients whose cancer has metastasized to the liver, the 5-year survival rate is only 11%.2
Today, patients urgently need new treatment options that are designed to address the unique challenges specific to liver tumors. Despite progress made in cancer treatment, patients with primary or metastatic liver tumors still experience poor outcomes, as these tumors remain stubbornly difficult to treat. Two of the most significant barriers that prevent optimal delivery and performance of therapeutics for liver and pancreatic tumors include immune response suppression and ineffective drug delivery due to high intratumoral pressure. The high intratumoral pressure prevents medicine from entering the tumor, meaning patients often receive little benefit from new immunotherapy drugs such as checkpoint inhibitors and CAR T-cell therapies. While these treatments may help reduce symptoms, there is no cure for liver metastases.
Learn more about the educational resources offered through Liver Central at livercentral.org.
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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.
About TriSalus Life Sciences TriSalus Life Sciences is an immunotherapy company on a mission to extend and improve the lives of patients living with liver and pancreatic tumors. By integrating an immunotherapeutic with innovative drug delivery technologies, TriSalus’ platform seeks to address two of the most significant barriers that limit the effectiveness of current treatments for liver and pancreatic tumors: immunosuppression and high intratumoral pressure.
The company is studying the ability of SD-101, a potentially first-in-class, investigative TLR9 agonist, to reactivate the immune system within the liver and pancreas to enable more durable responses to other immunotherapeutics (e.g., checkpoint inhibitors, CAR T-cell therapy) and improve patient outcomes. The platform, which leverages TriSalus’ proprietary Pressure-Enabled Drug Delivery™ (PEDD™) method of administration, modulates pressure and flow within blood vessels to improve the amount of therapy delivered to the tumor. While meaningful progress in these difficult-to-treat diseases will not be easy, TriSalus is focused on advancing science and technological innovation to transform outcomes for patients. To learn more, visit trisaluslifesci.com and follow @TriSalusLifeSci on Twitter and LinkedIn.
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
In 2020, 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. The recommendations presented in the U.S. NASH Action Plan were developed to address critical actions necessary to stop the rise of this life-threatening disease. Issues include a lack of awareness and education, lack of agreement on how to diagnose, lack of standardized patient management and treatment for NASH, and a lack of NASH-specific policy initiatives. Since the U.S. NASH Action Plan’s creation, the liver community has worked collaboratively to move the field forward and elevate conversations surrounding NASH. As we approach the end of 2021, we take a moment to recognize and highlight the achievements of our NASH Council members, stakeholder groups, and affiliate partners who have stepped up to address these issues.
Throughout 2021, GLI’s NASH Council member organizations worked tirelessly to promote advancement in NASH. We have witnessed the discovery of new therapeutic solutions for lifestyle management such as the development of the GLI nutrition app (with NutriStyle). The American Gastroenterological Association worked with the American Diabetes Association, American Osteopathic Association, Endocrine Society, and the Obesity Society on their development of a NAFLD/NASH Clinical Care Pathway. The European Association for the Study of Liver Disease updated guidelines on the use of non-invasive techniques.
GLI hosted the first NASH Externally-Led Patient Focused Drug Development meeting for the FDA. Stepping up to address the lack of NASH treatment availability, GLI applauds the actions of the FDA to grant breakthrough device designation for Orbera® Intragastric Balloon (IGB) as a treatment for NASH. Through the creation of patient advisory boards, our NASH Council members, Boehringer Ingelheim and Pfizer Inc. fostered a collaborative discussion with GLI-identified patients to ensure their perspectives were incorporated into design. There has been unprecedented momentum gained in the NASH policy realm as GLI continued to work with partners and patient advocates in the liver community to advance policy supporting liver patients through the reintroductions of TheLIVER Act, The NASH Care Act, and The Recognizing October as Liver Cancer Awareness Month Resolution.
Only together we can achieve victory for patients and caregivers who are impacted by this progressive, deadly disease.
Donna R. Cryer, JD President & CEO Global Liver Institute
GLI News
GLI Led First-Ever NASH Externally Led Patient-Focused Drug Development (EL-PFDD) Meeting
On November 4th, GLI, in collaboration with the GLI Liver Action Network (LAN), led the first-ever EL-PFDD Meeting on NASH. This virtual event, viewed by a global audience, included two panels of patients and caregivers impacted by NASH. The successful meeting provided the FDA, as well as the medical community, an opportunity to obtain a wide range of patients’ and caregivers’ input on NASH, including their perspectives on their condition, its impact on daily life, and the urgency around developing therapies. Read more in our Patient Perspective section below.
If you have been impacted by NASH, the GLI LAN and GLI invite you to participate in this important survey to help develop future treatments for NASH. The results from this survey will be included within the final EL-PFDD outcome report. Take the survey
Global Liver Institute Recognized with Two Advocacy Awards for Enduring Contributions and Sustained Service
GLI President & CEO Donna R. Cryer, JD, is the first-ever, proud recipient of the AASLD “Distinguished Advocacy Service Award” at the 2021 Liver Meeting. The Distinguished Advocacy Service Award is given to an advocacy organization or individual in honor of sustained service to the liver disease community in general. The award recognizes service provided to the hepatology community over an extended period that raises awareness or garners public and federal legislative support and promotes liver health and quality patient care.
The RARE Champions of Hope Founder’s Award — which Mrs. Cryer received a week later on November 18 at a ceremony that was part of the Global Genes RARE Health Equity Summit in Philadelphia, Pennsylvania — recognizes founders of impactful organizations in the rare disease community and acknowledges a commitment to connecting, empowering, and inspiring the community and advocating for people living with a rare disease.
GLI Staff Representation Throughout AASLD The Liver Meeting Digital Experience (TLMdx)
Grit, Grace, Gratitude, and Resilience: What You Wish Your Doctors Knew About You with Donna Cryer, JD, GLI Founder and CEO At this session, Donna R. Cryer, JD, Founder, President and CEO of GLI, used elements from her personal patient and extensive professional journey to illustrate how we can collectively move towards acknowledging the patient within the person and the person with the patient, expand on the power of purpose and the purpose of power, and elaborate on the seven habits of highly effective patient leaders.
Liver Action Network – The Evolution of Community Liver Advocacy with Andrew Scott, GLI Policy Director At this community conversations session, Andrew Scott, GLI Policy Director talks about how the Liver Action Network (LAN) acts as a first-of-its-kind affiliation model that facilitates provision of strategic mentorship, technical assistance, to LAN Roundtable Member Organizations, and affords a central structure for the formulation of policy positions and programmatic solutions by advocates, whether patients, family members, caregivers, or providers. Community members had the opportunity to meet with LAN members in this interactive discussion.
Abstract Tour: Pediatrics & Rare Disease with Robert Mitchell-Thain, GLI Pediatric and Rare Liver Diseases & Patient Insights Director
At this patient forum, Robert Mitchell-Thain, GLI Pediatric and Rare Liver Diseases & Patient Insights Director, led the patient community on a virtual tour through some of the abstracts in the areas of pediatrics and rare liver diseases presented at this year’s TLMdx.
NASH Summit 2021
For the 5th year, the NASH Summit brought cutting edge insights and thought-leading discussion to advance the front line of NASH candidate success. As the world’s largest gathering of NASH drug developers, this groundbreaking digital industry-specific discussion and networking forum is the unrivaled conference of the NASH biopharma calendar. GLI’s NASH Programs Director, Jeff McIntyre, presented at this year’s virtual event.
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 episodes of Surfing the NASH Tsunami podcast featuring members of GLI staff.
Day Three at the 2021 TLMdx from AASLD featuring GLI NASH Programs Director, Jeff McIntyre, Profs. Scott Friedman and Michelle Long, and Dr. Naim Alkhouri join Louise Campbell and Roger Green to review some of the most important and exciting presentations from the first three days of the 2021 TLMdX.
Day Four at the 2021 TLMdx from AASLD featuring GLI NASH Programs Director, Jeff McIntyre, Drs. Michael Charlton, Mazen Noureddin and Stephen Harrison join Louise Campbell and Roger Green to review some of the most important and exciting presentations from the final two days of the 2021 TLMdX.
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.
Patient Experiences Shared at First-Ever NASH EL-PFDD Meeting
On November 4, 2021, GLI was joined by members of the liver advocacy community to provide their input on NASH, including their perspectives on their condition, its impact on daily life, and the urgency around developing therapies to the U.S. Food and Drug Administration (FDA).
“Is NASH a benign disease?” asked Donna Cryer, JD – an important question posed to the patient panel.
Anthony: “It is far from a benign disease”.
Megan: “It is not silent at all. It is silent in the way that it does not present in the same way.”
John: “A medical student said, oh that’s not a big deal”. “It is something we need to pay attention to and monitor and treat.”
Terri: “When people say it is not serious…they see me on my good days, and not my challenging days. It is a challenge. It is not a benign condition in any form. It is a killer.”
The NASH EL-PFDD Meeting is a critical first step to move the field of NASH forward, as it provides the medical community with a deeper understanding of the impacts of NASH from a patient and caregiver perspective. Watch the testimonies.
GLI is pleased to welcome Mid South Liver Alliance as one of the newest members of the GLI NASH Council. Recognizing the need in the Mid-South to support people with liver disease, the Mid South Liver Alliance was formed to provide education for patients and their families and to sponsor advocacy efforts to target funding and research by working with political leaders.
Global NASH Updates
Referral Care Paths for Non-Alcoholic Fatty Liver Disease-Gearing up for an Ever More Prevalent and Severe Liver Disease
It is currently estimated that over 25% of Europeans have NAFLD. The unnoticed progression of NAFLD and limited awareness among health care professionals both lead to over‐referrals and under-diagnosis. Despite the rising prevalence and severity of NAFLD, there is still much room for improvement among health care professionals across the lines of care and also on the national guideline level. According to EASL‐EASD‐EASO guidelines, non-invasive tests (NITs) should aim to identify and assess NAFLD in individuals with increased metabolic risk in primary care. Read the review.
EASL Published Nonalcoholic Fatty Liver Disease: Patient Guidelines
EASL recently published a patient guideline intended for all patients at risk of or living with NAFLD. NAFLD is the most frequent chronic liver disease worldwide and comes with a high disease burden. This guide summarizes the current knowledge relevant to NAFLD and its management. It has been developed by patients, patient representatives, clinicians, and scientists and is based on current scientific recommendations, intended to support patients in making informed decisions.
Research & Development
Lipocine Announces FDA Grants Fast Track Designation to LPCN 1144 for Treatment of Non-Cirrhotic NASH Lipocine Inc., a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to LPCN 1144 as a treatment for non-cirrhotic NASH. The FDA’s Fast Track Designation is designed to accelerate the development and expedite the review of products that are intended to treat serious diseases and for which there is an unmet medical need.
Association of Bariatric Surgery With Major Adverse Liver and Cardiovascular Outcomes in Patients With Biopsy-Proven Nonalcoholic Steatohepatitis
NASH is rapidly becoming the leading cause of cirrhosis and hepatocellular carcinoma and is also significantly linked to cardiovascular disease. When lifestyle modifications are no longer sufficient, bariatric surgery may be considered to assist patients with weight loss. In this retrospective cohort study of 1158 patients, researchers found that among patients with NASH and obesity, bariatric surgery was significantly associated with lower risk of major adverse liver outcomes as well as cardiovascular events.
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.
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.
The most recent module shared online focuses on Designing the Ideal NASH Therapy and features Stephen Harrison, MD, FACP, FAASLD, COL (ret.) USA, MC, as the presenter. NASH Core Curriculum is supported by educational grants from Gilead Sciences and Novo Nordisk Inc.
U.S. NASH Action Plan: Recommendations for Payors
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. This month, we’re highlighting some of the recommendations for payors:
Education: Engage patient advocates and patient advocacy organizations across the spectrum of NAFLD/NASH and with a diversity of common comorbidities to understand the impact and integrated care needs of patients.
Diagnosis: Reimburse for non-invasive diagnostics to make safer, cost-effective screening and treatment response methods accessible to more clinicians and patients.
Patient Management/Treatment: Reimburse (across plan types) for integrated, whole person care including evidence-based NAFLD/NASH-related services such as dieticians, exercise specialists, weight loss medications, and bariatric surgery.
Policy Effort/Legislation: Collaborate with medical societies to conduct a study within medical insured populations prior to setting budgets/internal policies.
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
Economic and Clinical Burden of Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes in the U.S. NASH is strongly associated with type 2 diabetes mellitus (T2DM). Patients with both T2DM and NASH have increased risk for adverse clinical outcomes, leading to higher risk for mortality and morbidity. Additionally, NAFLD and NASH are associated with significant health care utilization. This is the first study to assess both the economic and clinical burden of NAFLD and NASH in patients with T2DM. Read the study.
Food Concerns Linked to Liver Disease New research has highlighted the importance of food insecurity as a contributing factor to outcomes in U.S. adults with NAFLD and advanced fibrosis. “Food insecurity…has emerged as an important social determinant, one associated with a greater risk of NAFLD and NAFLD-associated liver fibrosis,” says Dr. Ani Kardashian, an assistant professor of clinical medicine at the Keck School of Medicine of USC. Read the database analysis.
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.
In the past, efforts in liver advocacy were siloed by individual liver disease lessening their impact and limiting their effectiveness at shaping national health policy. In 2021 thanks to the efforts of Global Liver Institute (GLI), GLI’s newly created Liver Action Network (LAN), and collaboration throughout the liver advocacy community, we finally saw the value of synchronized engagement in liver health policy. The theme for 2021 really was collaboration, and how collaboration can lead to a shifting of the conversation on liver health. As the year comes to a close, we thought it would be worthwhile to highlight the variety of collaborative liver advocacy actions that occurred throughout the year.
January Global Liver Institute (GLI) released the U.S. NASH Action Plan and applauded the introduction of the COVID-19 Prevention and Awareness Act (CPAA). GLI also applauded the leadership of Congresswoman Nydia Velázquez (D-NY) in the introduction of the COVID-19 Prevention and Awareness Act (CPAA).
The U.S. Food and Drug Administration (FDA) had their NASH Drug Development briefing titled: “Regulatory Perspectives for Development of Drugs for Treatment of NASH.” GLI expressed appreciation that the FDA had followed through on the 2020 line of dialogue and provided a response to many of their previously communicated concerns around acceptable endpoints, biomarkers, non-invasive diagnostics, and accelerated approval.
February The new Biden Administration began taking action on a few liver health policy issues this month; President Biden restored ties with the World Health Organization (WHO) on his first day in office, and also proposed an emergency relief package for the COVID-19 pandemic.
Additionally, the Improving Social Determinants of Health Act (H.R. 379) was introduced by Rep. Nanette Barragán (D-CA) and allowed for the creation of a Social Determinants of Health (SDOH) Program at the U.S. Centers for Disease Control and Prevention (CDC). Find out more about these highlights in this month’s LHPU.
March GLI participated in the Digestive Diseases: Digestive Disease National Coalition 31st Annual Public Policy Forum (March 4-10), as well as several Obesity Care Week advocacy days to build support for the Treat and Reduce Obesity Act (TROA). GLI and many others within the liver advocacy community also advocated for these initiatives, and other critical liver policy issues, during the virtual Liver Capitol Hill Day that took place on March 24, 2021.
Furthermore, the Research Investment to Spark the Economy (RISE) Act was reintroduced into Congress with backing from Senators Edward J. Markey (D-Mass.), Thom Tillis (R-N.C.), Gary Peters (D-Mich.), and Susan Collins (R-Maine) on February 5, 2021. This act provides nearly $25 billion in funding for research outside the realm of COVID-19. Find out more about these highlights in this month’s LHPU.
April GLI participated in and advocated on behalf of patients with Hepatocellular Carcinoma (HCC) at the April Oncologic Drugs Advisory Committee (ODAC). As part of this participation, GLI sent a formal letter highlighting that HCC patients need a variety of therapeutic options at their disposal. GLI also participated in the Generic Drug User Fee Amendments (GDUFA) Reauthorization Stakeholder Meeting, where we stressed the importance of innovative products within the liver space, particularly in the treatment of NASH.
GLI also worked with the Liver Advocacy Community on submitting a letter to USPSTF asking for the inclusion of NAFLD/NASH within the recommendation statement on screening for prediabetes and type 2 diabetes, and urging the task force to utilize people-first language (attached). USPSTF published the final recommendation statement in August, and thankfully took the community’s recommendations by adjusting the statement to include people-first-language, including a highlighting of the risks of NAFLD, NASH, and diabetes.
On April 14, 2021, the John Lewis NIMHD Research Endowment Revitalization Act (H.R. 189) was passed in the House and sent to the Senate — this bill expands eligibility for research endowments available through the National Institute on Minority Health and Health Disparities (NIMHD). Find out more about these highlights in this month’s LHPU.
May On May 4, 2021, GLI witnesses (Donna Cryer and LaQuayia Goldring) testified at the U.S. House of Representatives Subcommittee Hearing on Reforming the Organ Transplantation System. On May 27, 2021, GLI formally announced its Liver Action Network (LAN). GLI’s LAN provides the opportunity for individual advocates, and community roundtable member organizations, to use their voices and insights from lived experiences to advance liver health advocacy at a local, state, national, and global level. Read more here.
June On June 10, 2021, GLI’s fourth International NASH Day took place and was a remarkable global success: 120 partners from over 35 countries and more than 25 international organizations participated.Additionally, the International Liver Congress Event took place from June 23-26, 2021.
The Draft 21st Century Cures 2.0 Act was released in the U.S. House of Representatives along with the Medical Nutrition Equity Act which was reintroduced June 7, 2021. Also, the VALID Act was also reintroduced in the month of June.
July Virtual Rare Disease Week on Capitol Hill took place from July 14 – July 22 and met with significant success. On July 29, 2021, the U.S. House of Representatives voted on and passed the first iteration of the Fiscal Year 2022 Labor, Health and Human Services, Education, and Related Agencies Funding Bill.
July also sawGLI announcing the expansion of its LAN to include collaborations with the Liver Coalition of San Diego, the Liver Wellness Foundation, the Midsouth Liver Alliance, and the Texas Liver Foundation. GLI’s LAN now represents more than 40 U.S. states, 2 countries, and 12 community liver advocacy organizations. Find out more about these highlights in this month’s LHPU.
August GLI responded to the Updated Organ Transplant Societies’ Statement on Vaccine Efficacy in Transplant Recipients. GLI and its LAN also responded to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Request for Information on the agency’s strategic plan, and urged the agency to consider liver health as an integral part of public health, from nutrition, physical activity, prevention, control and management of risk factors, to education, support, optimal clinical pathways, and policy for children, adults, and seniors. The August issue of The American Journal of Gastroenterology was released and included clinical discussions of diet-associated NAFLD risk and increased risk of mortality from COVID-19 among Proton pump inhibitors (PPI) users. Read more about these highlights in this month’s LHPU.
September GLI’s Advanced Advocacy Academy (A3) took place virtually on Capitol Hill September 21-23, 2021 and was a great success! More than 80 A3 advocates participated in and met with more than 40 Congressional offices as part of the virtual day on the Hill. Advocates were able to virtually share stories, and engage policymakers in a discussion about liver health, and the liver advocacy community’s policy priorities including the Liver Illness, Visibility, Education and Research Act (LIVER Act), the NASH Care Act, and many other vital pieces of legislation.
Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) announced that the committee had held a full Committee markup on the Build Back Better Act Monday, September 13, at 11 a.m. Read More about these highlights in this month’s LHPU .
October The LIVER Act was reintroduced, and the Liver Cancer Awareness Month Resolution was introduced on October 21, 2021. GLI thanked Representative Velázquez and Senator Duckworth for their leadership on the reintroduction of the LIVER Act, and the introduction of the Liver Cancer Awareness month resolution. GLI President and CEO Donna Cryer highlighted that their leadership would be crucial to moving “the field forward and shifting the conversation to shine a spotlight on liver cancer, and liver cancer health disparities,” allowing us to finally elevate liver health to its rightful place on the national public health agenda. Read more in our press release here.
Liver Cancer Awareness month took place during the month of October and allowed for a major swell in liver health/policy awareness including the launch of the inaugural State of Liver Cancer Report, and a highlight of Liver Cancer Awareness month by the CDC. GLI also collaborated with the Hepatitis B Foundation, NASH kNOWledge, and the Taiwan Hepatitis Information and Care Association (THICA) on a virtual Congressional briefing that explored the challenges and opportunities surrounding liver cancer around the globe, with the goal of improving health equity for all patients going through their own liver cancer journey.
November The NASH Externally-Led Patient Focused Drug Development (EL-PFDD) Meeting was held on November 4th (more information below). Representative DeGette and Representative Upton announced the official Cures 2.0 bill on November 16, 2021 and the House officially passed the Build Back Better Act November 19, 2021. Read more about these highlights in this month’s LHPU.
It has been a great year of impactful advocacy and change and we are so excited about the multitude of y possibilities in 2022. We will continue our efforts to move the needle on liver health policy around the world.
Donna R. Cryer, JD President & CEO Global Liver Institute
OPEN ADVOCACY OPPORTUNITIES
Ask Congress to Support the Liver Illness Visibility, Education, and Research (LIVER) Act The LIVER Act is a public health initiative that will help people of all ages, lifestyles, and ethnic backgrounds reduce their risk for liver cancer and related risk factors like viral hepatitis and NASH. Don’t miss this opportunity to show the groundswell of support for the LIVER Act across the country, and urge your legislators to take action. Take action here.
Ask Congress to Support the Treat and Reduce Obesity Act (H.R. 1577 and S. 596) TROA would expand Medicare coverage to include screening and treatment of obesity from a diverse range of healthcare providers who specialize in obesity care. Take action here.
GLI POLICY DEVELOPMENTS
GLI led NASH EL-PFDD Meeting on November 4th, 2021 GLI was excited to work with the liver advocacy community, including the member organizations within GLI’s LAN , to lead the first nonalcoholic steatohepatitis (NASH) ExternallyLed Patient Focused Drug Development Meeting (EL-PFDD) on November 4, 2021. A PFDD meeting of this magnitude allowed the FDA and other stakeholders across the medical field to obtain a wide range of patients’ and caregivers’ input on NASH, including their perspectives on their condition, its impact on daily life, and the urgency around developing therapies. It also highlights the FDA’s willingness to form meaningful partnerships that will contribute to the quality of the agency’s regulatory decision-making and lend credibility to future therapy review processes. The NASH EL-PFDD meeting marked the continuation of a series of productive conversations that the liver community has had about hepatology with the FDA throughout 2020, and 2021. View the NASH EL-PFDD Recording. A full NASH EL-PFDD outcome report will be released in the near future. It will explore in detail the data gathered from responses to GLI’s patient with NASH and caregiver survey, along with testimonies from the diverse group of patients and caregivers impacted by NASH that participated in the EL-PFDD meeting.
Launch of GLI’s Liver Central On December 8th, GLI launched Liver Central as a comprehensive online guide for all things related to liver cancer. With Liver Central, GLI looks forward to reinventing how liver cancer information is accessed. Liver Central will act as a hub that allows all stakeholders across the medical field, whether they are providers or patients and caregivers, to access vital information. This website will act as a critical resource that will give interested stakeholders the necessary tools, and most current information, to shift the conversation on liver cancer. Resources and tools on this site will continue to be built upon and expanded , and will be updated on a regular basis.
GLI Advocacy Letters: GLI joined more than 156 organizations in support of the DIVERSE Trials Act (H.R. 5030/S. 2706) GLI signed onto a Joint Letter to Congressional Leadership urging them to Protect the Orphan Drug Tax Credit for Individuals Living with Autoimmune Disease
Updates from the Liver Action Network
See more about these updates in the GLI Liver Action Network on the bottom of our Take Action Page!
The Texas Liver Foundation’s Website is now Live Click this link to learn more about the work of the Texas Liver Foundation and their initiatives to advance liver health.
Texas Liver Foundation Virtual Pediatric Liver Transplant Survivors-a Celebration The event will take place virtually on December 16th from 5:00PM to 6:00PM CST. Join a panel of Texas patients and families, moderated by leading Texas transplant surgeons. Register here.
The Fatty Liver Foundation has its SUNN Report Published in PLOS ONE On November 30, 2021 the Fatty Liver Foundation Foundation had its report published in PLOS One Journal. The report, which focused on screening for undiagnosed non-alcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), was a population-based screening study that aimed to provide proof of concept to encourage community-level screening and detection for this non-communicable disease. Read the full article here.
HepCURE Holds Hepatitis C Informational Events The first event held by HepCURE was a community outreach day in Toronto as part of the theme “Take 15”. This theme emphasized taking a 15-min break and learning about Hepatitis C in order to get tested. The event was supported by Gilead Canada. HepCURE held a similar second event Dec 3, 2021 in Niagara Falls.
NASH Knowledge Holds Virtual Conference and Updates their Patient & Provider Program in partnership with the Community Liver Alliance. On November 18, 2021, NASH Knowledge held a free virtual conference surrounding its Patient & Provider Program.. The conference focused on updating patients and caregivers on new developments surrounding NASH in the healthcare world. Several esteemed speakers with knowledge on liver health spoke .These two organizations partnered with each other to update their Patient & Provider Program, which aims to provide patients with NASH and caregivers with information to expand their knowledge of support and resources for NASH. Read more in their newsletter here.
Liver Coalition of San Diego Holds virtual webinars for Hepatitis B patients On November 16, 2021, the Liver Coalition of San Diego held a virtual Q&A Webinar for Hepatitis B patients. The Q&A answered questions and provided support and resources for newly diagnosed patients. See the full video here.
The Northeast Ohio Liver Alliance will hold an Upcoming Webinar on Viral Hepatitis On December 14, 2021 from 5:30-6:30pm the Northeast Ohio Liver Alliance hosted a webinar on the elimination of Viral Hepatitis in the U.S. The webinar included a variety of expert speakers. Read more here.
GLOBAL NEWS
National University Cancer Institute, Singapore and MiNA Therapeutics announce Clinical Study about Liver Cancer The Phase 1 Clinical Study will aim to examine MTL-CEBPA in combination with the current standard of care for advanced liver cancer. MTL-CEBA has been reported to improve anti-tumor activity in drugs used for cancer treatment. On December 1, 2021 the first patient was dosed at the study location: NCIS clinical trial facility at the National University Hospital in Singapore. The doctors aim to study response rate and examine how new treatment combinations can improve patient outcomes. Read more about the clinical trial here.
U.S. FEDERAL NEWS
The House passed the Build Back Better Act on November 19, 2021 The Build Back Better Act has been passed by a vote of 220-213. The Act provides funding for four major areas: Health Care Infrastructure and Workforce, Pandemic Preparedness, Maternal Mortality, and Other Public Health Investments. Read a full section by section summary here and the bill text here.
Representative DeGette and Representative Upton announce the official Cures 2.0 bill on November 16, 2021 The bipartisan duo announced on November 16, 2021, their long-awaited Cures 2.0 bill to speed up medical innovations and create a new federal research agency. The bill hopes to allow for a new biomedical research agency and bring new treatments and technologies through Medicare to seniors faster. Read more about the bill and Degette and Upton’s statements here.
U.S. NGO NEWS
The Digestive Disease National Coalition Held its virtual Fall Forum November 15-19, 2021 The Forum’s theme was “Digestive Disease Patient Priorities” and included an in-depth look at key digestive disease policy initiatives, including the Safe Step Act. The Forum included a Webinar where policymakers, caregivers, and patients received an overview of the coalition’s funding priorities, and information on the Safe Step Act.
UC Davis Health Team developed first PET imaging based tool to detect liver inflammation in NAFLD patients The health team developed the positron emission tomography (PET) scan imagining machine to help detect inflammation in patients with non-alcoholic fatty liver disease. Read More Here.
Obesity Care Advocacy Network (OCAN) hosted a briefing on November 19, 2021 OCAN leaders, along with Dr. Fatima Cody-Stanford, obesity medicine specialist at Harvard Medical School, talked through public opinion on how the federal government should address obesity, and whether people believe federal health programs like Medicare are updated regularly enough to address obesity and racial disparities in health care in the U.S.
NAME TO KNOW
Dr. Chee Cheng Ean
Dr. Chee is a senior Consultant at the Department of Haematology-Oncology at the National University Cancer Institute, Singapore. She designed a groundbreaking clinical trial and study focusing on bettering treatment for patients with advanced hepatocellular carcinoma (HCC) or liver cancer. She emphasized in her research that “with only 30% of patients benefiting from objective responses to first line standard of care, new treatment combinations are needed in order to improve patient outcomes.” Read more about her research here.
On February 4, 2022 10 AM ET, Global Liver Institute led an Externally-Led Patient-Focused Drug Development Meeting (EL-PFDD) on Primary Biliary Cholangitis (PBC). This online event is open to the public with registration required.
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.
The patient perspective is vital in helping to provide context when FDA makes regulatory decisions for new drugs. PFDD meetings give FDA and other key stakeholders, including medical product developers, health care providers, federal partners, an important opportunity to hear directly from patients, their families, caregivers, and patient advocates about the symptoms that matter most to them, the impact the disease has on patients’ daily lives, and patients’ experiences with currently available treatments. This input can inform FDA’s decisions and oversight both during drug development and during review of a marketing application.
Donna R. Cryer, JD, President and CEO, Honored with Awards from the American Association for the Study of Liver Diseases (AASLD) and Global Genes for leadership in connecting, empowering, inspiring and advocating for people living with liver disease
(Washington, DC, Friday, November 19, 2021)——Global Liver Institute (GLI), the only patient-led liver health nonprofit operating internationally, celebrates its President and CEO, Donna R. Cryer, JD, receiving both the AASLD Distinguished Advocacy Service Award and Global Genes RARE Champions of Hope Founder’s Award within the same week.
“It is an honor to receive these awards from AASLD and Global Genes — longstanding and deeply valued GLI partners — in recognition of all that we do to improve the lives of the half a billion people around the world who are living with more than 100 different types of liver diseases,” said Mrs. Cryer, a rare liver disease patient and 27-year transplant recipient. “These awards are particularly significant to me because they also celebrate patient leadership and Black female leadership which are rarely recognized outside of siloed spaces. On behalf of Team GLI, I want to thank all of our partners- clinicians, researchers, industry innovators, policy makers, and patients – for facilitating our efforts to elevate and amplify the patient voice and the value of diverse lived experiences in improving liver health care and policy. It has been a time of tremendous turmoil across the world, but also one of generosity, fortitude and empathy. We continue to commit ourselves to creating a united liver health community marked by inclusiveness, equity, and effectiveness.”
The AASLD Distinguished Advocacy Service Award, which recognizes sustained service to the hepatology community by raising awareness, garnering public and legislative support, and promoting liver health and patient care, was awarded to GLI during The Liver Meeting Digital Experience™ on November 12. The RARE Champions of Hope Founder’s Award — which Mrs. Cryer received just a week later on November 18 at a ceremony that was part of the Global Genes RARE Health Equity Summit in Philadelphia, Pennsylvania — recognizes founders of impactful organizations in the rare disease community and acknowledges a commitment to connecting, empowering, and inspiring the community and advocating for people living with rare disease.
“Our strong and steady growth over the past seven years has redefined the scope and scale of opportunities to serve those who live with liver disease as well as the families and caregivers who support them,” said GLI Board Chair Victor J. Reyes, MBA. “As we reflect on all we have accomplished, it further underscores all we have yet to do. We hope these awards will highlight opportunities to partner with GLI to expand our ability to provide strategic leadership, infrastructure, training and support for the community of liver health organizations and patients across the United States and around the world. Both the Distinguished Advocacy Service Award and RARE Founder’s Award provide much appreciated recognition and encouragement as we continue to do this important work.”
GLI has had the honor of making an impact and serving the community in various ways, including:
Training over 200 advocates from 36 U.S. states and 15 countries at our Advanced Advocacy Academy (A3) over four years
Engaging over 200 organizational members —medical societies, advocacy organizations, industry innovators — through our NASH Council, Liver Cancers Council and Pediatric and Rare Diseases Council
Representing two countries, more than 40 U.S. states and 11 community liver advocacy organizations through GLI’s Liver Action Network (LAN), an affiliation model that affords a central structure for the formulation of policy positions and programmatic solutions
Introducing the Liver Illness, Visibility, Education and Research (LIVER) Act with U.S. Representative Nydia Velázquez (D-NY) and U.S. Senator Tammy Duckworth (D-IL) to improve the lives of all people impacted by liver disease
Accelerating the acceptance of non-invasive diagnostics as an alternative to biopsy with the Beyond the Biopsy initiative
Increasing global awareness and early intervention of NASH on International NASH Day: 120 partners, 36 countries. #NASHDay – 11.5 million impressions
Raising awareness of liver cancer and reducing the stigma of liver disease through our #OctoberIsForLivers and #BossesWearBurgundy campaigns reaching 11.5 million impressions
Providing timely information to patients living with liver disease through weekly GLI LIVE shows
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.
The liver advocacy community — with the GLI Liver Action Network leading the way — has elevated patient voices through a variety of initiatives throughout September and October. Here are some advocacy highlights that have occurred over the past month:
The LIVER Act – Reintroduced October 21, 2021 This past month the liver advocacy community applauded the actions of U.S. Representative Nydia Velázquez (D-NY) and U.S. Senator Tammy Duckworth (D-IL) to improve the lives of all people impacted by liver cancer by reintroducing the LIVER Act. We now need your help to urge other Members of Congress to cosponsor each of these bills, urge action on each within Congressional committees, and support their inclusion in other legislation. More information on the reintroduction of the LIVER Act is available here. Please consider reaching out directly to your member of Congress and ask them to become a cosponsor of the LIVER Act.
The State of Liver Cancer Educational Congressional Briefing Global Liver Institute (GLI), the Hepatitis B Foundation, NASH kNOWledge, and the Taiwan Hepatitis Information and Care Association (THICA) in collaboration with Representative Nydia Velázquez (D-NY) led a October’s Liver Cancer Awareness Month Educational Briefing on The State of Liver Cancer. The virtual educational event explored the challenges and opportunities surrounding liver cancer around the globe, with the goal of improving health equity for all patients going through their own liver cancer journey. Watch the recording on YouTube, Facebook, or Twitter.
Advanced Advocacy Academy (A3) Virtually on Capitol Hill GLI’s A3 Advocacy Day took place during September. More than 80 A3 advocates participated and met with more than 40 congressional offices. Each advocate was able to elevate liver health policy and discuss a variety of policy initiatives including the LIVER Act and the NASH Care Act. A full A3 2021 report will be available soon.
Liver Action Network (LAN) Growth and Action This past month, the LAN proudly welcomed two more member organizations: the Northwest Ohio Liver Alliance and HepCure (based in Canada). See the full LAN here.
NASH Externally Led Patient Focused Drug Development (EL-PFDD) Meeting On November 4th, GLI, in collaboration with the GLI Liver Action Network, led an EL-PFDD Meeting on NASH. This virtual event included two panels of patients and caregivers impacted by NASH. The meeting provided the medical community an opportunity to obtain a wide range of patients’ and caregivers’ input on NASH, including their perspectives on their condition, its impact on daily life, and the urgency around developing therapies. A full outcome report for this event will be made available in the near future.
If you have been impacted by NASH, the GLI Liver Action Network and GLI invite you to participate in this important survey to help develop future treatments for NASH. The results from this survey will be included within the final EL-PFDD outcome report. Take the survey here. The collective liver advocacy over the past few months demonstrates the building of momentum, and groundswell of support liver health policy has across the country. If you are looking to join the GLI Liver Action Network, and help us in the fight to elevate liver health, please check out the GLI take action page.
Donna R. Cryer, JD President & CEO Global Liver Institute
OPEN ADVOCACY OPPORTUNITIES
NASH EL-PFDD Survey
Have you been impacted by NASH?
The Liver Action Network and GLI need your help to educate the medical community about the priorities and preferences for addressing NASH. We invite you to participate in this important survey to help develop future treatments for this devastating disease.
This survey is designed to collect anonymous information about your priorities and preferences for addressing NASH including issues centered around diagnosis, clinical trial access, and available treatment options. Data from this survey will be used by Global Liver Institute, a 501(c)3 patient advocacy and support organization, for research in our mission to help develop potential treatments for NASH. Take the Survey
Ask Congress to Support the Liver Illness Visibility, Education, and Research (LIVER) Act The LIVER Act is a public health initiative that will help people of all ages, lifestyles, and ethnic backgrounds reduce their risk for liver cancer and related risk factors like viral hepatitis and NASH. Take action here.
GLI POLICY DEVELOPMENTS
GLI Applauds the CDC’s Liver Cancer Awareness Month Statement
In a Dear Colleague letter, the Centers for Disease Control and Prevention (CDC) recognized Liver Cancer Awareness month, and the opportunity to draw attention to the global burden of liver cancer. In addition, the letter highlighted the CDC’s various efforts and programs that aimed to increase early detection and screening of liver cancer. The full letter is available here.
President and CEO of GLI, Donna Cryer, JD, Highlights Changes in Value Assessment and Policy Post COVID-19
GLI President and CEO, Donna Cryer, JD, details the fundamental shifts in thinking, behavior, and action that have occurred as a result of COVID-19. She discussed three shifts in thinking: “We are all connected”, “We are all essential”, and “Sometimes time is a choice”. She detailed how these shifts in thinking are essential to understanding and evolving our health care and how we value it. Read the full article here.
GLI Advocacy Letters:
Ad Hoc Sign-on Letter to Appropriations Leadership re. Finalizing FY 2022 NIH Funding
GLI joined the Rare Disease Diversity Coalition Government Regulation, Legislation, and Policy Working Group on an Orphan Drug Tax Credit Congressional Letter
GLI joined the Viral Hepatitis Advocacy Community on a letter urging the CDC to support Universal Adult Hepatitis B Vaccination
GLI signed onto a letter to Congress on extending the virtual care provisions included in the CARES Act for individuals with HDHP-HSAs before the Dec. 31 expiration is now live
GLI was added to a sign-on letter urging Congressional leaders to set funding levels for FY22, and making the case that CRs stymie desperately-needed faster medical, health, and scientific progress
GLI joined the Alliance for Connected Care in urging Congress to act now to extend the telehealth safe harbor enacted in CARES for those with HDHP-HSAs
GLI joined the HIV+Hepatitis Policy Institute in sending a letter to the Senate Finance Committee in support of practical solutions to increase patient affordability of prescription drugs and to express concerns with some of the solutions being discussed, including price controls tied to international markets and QALYs
GLI signed onto a community sign-on letter supporting the enactment of the DoD Appropriations bill so that CDMRP programs can get funded
GLI joined the Obesity Care Advocacy Network in sending letters to the House Energy & Commerce and Ways & Means Committees and to the Senate Finance Committee. (House and Senate) urging action to address the growing number of Americans living with obesity who lack access to comprehensive care. A similar letter was also sent to the Biden Administration
GLI joined many organizations on a Part D out-of-pocket reform letter
Updates from the Liver Action Network
See more about these updates in the GLI Liver Action Network on the bottom of our Take Action Page!
GLI Liver Action Network thanks both Senator Duckworth and Representative Velázquez for introducing the LIVER Act
Through the reintroduction of the LIVER Act we can finally elevate liver health, prevent rising risk factors, and begin to address the variety of health disparities connected to liver cancer.
GLI Liver Action Network Sends Letter Urging CMS to consider unmet need in NASH, and support the FDA’s Breakthrough Designation for Intragastric Balloon as a treatment for NASH
As new therapies begin to become available for NASH, the last thing the advocacy community wants is a precedent being set with their IGB decision impacting patient access.
GLI Liver Action Network Urges Support for Viral Hepatitis Programs
As Congress begins to draft a final fiscal year (FY) 2022 spending package, we urged Congressional leadership to support the adoption of the House Appropriations Subcommittee on Labor, Health, and Human Services, Education, and Related Agencies Fiscal Year 2022 (FY2022) spending bill, and provide a $5 million increase to hepatitis programs at the Centers for Disease Control and Prevention (CDC).
AB 347 becomes law thanks to the Liver Coalition of San Diego
The Liver Coalition of San Diego’s advocacy efforts led to bill AB 347 being passed into law. See more information about the bill here.
AB 789 becomes law thanks to the Liver Coalition of San Diego
This bill will Offer Free Hepatitis B and C Screenings and address health disparities in AAPI and Black Communities. Press Release Linked Here.
Global Liver Institute and the Fatty Liver Alliance send a letter to The World Health Organization on NASH and Type 2 Diabetes
The Fatty Liver Alliance collaborated with the Global Liver Institute to send out a letter to the World Health Organization (WHO). This letter urged them to prioritize a more focused approach on the impacts and risks of Type 2 Diabetes on liver health, especially Nonalcoholic Fatty Liver Disease (NAFLD) and nonalcoholic steatohepatitis (NASH).
Fatty Liver NASH Update Event (November 18, 2021) The virtual conference event will take place Thursday November 18, 2021 from 6-9pm. The conference is aimed at patients and caregivers (but is open to everyone) and will focus on updating them on new developments surrounding NASH in the healthcare world. Several esteemed speakers with knowledge on liver health will speak. The event is free but registration is required. For more information see this link.
GLOBAL NEWS
The impacts of the SARS-CoV-2 pandemic on digestive/liver health health The United European Gastroenterology (UEG) Public Affairs Committee has published a position paper in the UEG journalto educate policymakers, patients, healthcare professionals, and the general public about the impacts of the coronavirus disease 2019 (COVID-19) pandemic on digestive/liver health. No safety issues have been reported in liver transplant recipients or patients with mild-moderate liver disease who received the COVID-19 vaccine. In one study from China, patients with non-alcoholic fatty liver disease reported mild side effects and produced neutralizing antibodies against SARS-CoV-2.
Commission signs contract for the supply of a monoclonal antibody treatment The Commission has signed a joint procurement framework contract with the pharmaceutical company Eli Lilly for the supply of monoclonal antibody treatment for coronavirus patients. The medicine is currently under rolling review by the European Medicines Agency.
Europe’s Cancer Plan This Interparliamentary Committee meeting provided an occasion for debate between European and national parliamentarians on the BECA (Beating Cancer) draft report, and on Europe’s Beating Cancer Plan presented by the EU Commission in 2021.
European Health Union: Towards a reform of EU’s pharmaceutical legislation The Commission has published a public 12 week consultation on the revision of the EU’s pharmaceutical legislation. The consultation will gather the views from both the general public and stakeholders to support the evaluation of and the impact assessment for the revision of the EU’s pharmaceutical legislation that is foreseen for the end 2022.
U.S. FEDERAL NEWS
The draft Senate Appropriations FY 2022 Federal Spending Report/Bill for HHS came out October 18,2021
The below sections in the draft directly address liver health issues: Increasing Hep B Vaccinations p. 78: Increasing Adult Hepatitis B Vaccination.—Given that hepatitis B is preventable through a safe and effective vaccine, the Committee is concerned that fewer than one third of adults age 19 and older are vaccinated. The Committee urges CDC to redouble its efforts to address this long-standing problem.
Liver Cancer: While advances in some cancers have made it possible to reduce the overall rate of cancer deaths over the last two decades, there has been limited progress reducing mortality for these diseases. The Committee directs NIH to provide a status update and timeline for the scientific framework within 60 days of enactment of this Act. The Committee also expects to be kept informed of NCI’s efforts on pancreatic, lung, glioblastoma, esophageal and stomach cancers. The Committee also requests that NCI to identify in the fiscal year 2023 CJ its research goals to advance progress for the deadliest cancers. The Committee encourages NCI to consider research opportunities that might support future development of a liver cancer screening test using the blood and saliva samples from the widespread national COVID–19 testing.
Hep B p. 152:The Committee recognizes the estimated $4,000,000,000 of annual medical costs associated with the care and treatment of those infected with the hepatitis B virus and urges NIH to redouble its efforts to identify more effective treatments for the disease.The Committee requests that NIH support an update of the Strategic Plan for Trans-NIH Research to Cure Hepatitis B to be completed before the end of fiscal year 2022
Minority Health pp 222-223: The Committee supports the OMH effort to lead collaboration across the Department to assess the health status and quality of life for racial and ethnic minorities in the United States. The Committee encourages OMH to support research or public health interventions related to a variety of diseases and help reduce racial/ethnic disparities within these diseases.
U.S. NGO NEWS
The Regulatory Relief Coalition (RRC) releases a statement on the Improving Seniors Timely Access to Care Act
On October 20, 2021 U.S. Senators Roger Marshall, M.D. (R-KS), Krysten Sinema (D-AZ), and John Thune (R-SD) introduced the Improving Seniors’ Timely Access to Care Act, bipartisan legislation that would improve timely access to quality care for seniors under Medicare Advantage. The bill will modernize the way Medicare Advantage plans and health care providers use prior authorization. The RRC released a press release applauding the senate for their action and in support of the legislation.
NAMES TO KNOW
Professor Bruce Hammock, U.C Davis
Professor Hammock and his team discovered a drug candidate that may help control the body’s often deadly inflammatory response to chemotherapy treatments, especially for pancreatic and liver cancer patients. They worked on rodent models with liver and pancreatic cancer, until they found they could use a combination of two drugs to reduce inflammation following chemotherapy. His research team, based in the laboratories of Dipak Panigrahy at Harvard Medical School and Hammock, announced their findings in Proceedings of the National Academy of Sciences (PNAS) September 29, 2021.
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.
People living with serious and chronic illnesses benefit from eating foods that are healthful in relation to their diagnosis. While a liver patient’s journey may feel hectic or their daily schedules impacted by requirements for treatment regimens, there is one aspect that they can help manage — their food. Nutrition is one of the most important aspects a patient can learn to manage regarding their health. It is a vital aspect of their healthcare prescription but also empowers patients to be more in charge of their lifestyle.
It is important for patients that conversations around food as medicine are elevated. GLI recognizes how critical it is to achieve a healthcare system in which nutrition and food are a routine part of evidence-based disease prevention and treatment. To do this, GLI is working to develop practical and accessible methods that are both evidence-based and patient-driven to help people eat and live healthier. GLI has partnered with NutriStyle Inc. to create a personalized nutrition app for people who want to maintain good liver health or are living with liver disease, diabetes, and other chronic conditions. The app supports patients creating 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. This new partnership reflects the importance of nutrition in preventing and managing liver diseases and related conditions.
Additionally, GLI has partnered with the Food and Nutrition Innovation Council at Tufts University’s Friedman School of Nutrition Science & Policy to address nutrition concerns for better liver health. This collaboration empowers GLI to work with leading nutrition scientists, companies, investors, and advocacy to better understand and promote breakthroughs in nutrition science, health, technology, behavior change, and technology.
With these initiatives and more, GLI is working to ensure every liver patient has access to comprehensive and timely information and resources, culturally and socially appropriate support, and equitable systems of care that they deserve to live their lives to the fullest.
Donna R. Cryer, JD President & CEO Global Liver Institute
GLI News
Register Today to Attend the Virtual NASH Externally-Led Patient-Focused Drug Development (EL-PFDD) Meeting
GLI is excited to work with the liver advocacy community, including member organizations within GLI’s Liver Action Network (LAN), to lead the first NASH EL-PFDD to be held virtually on November 4, 2021. 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 NASH, including their perspectives on their condition, its impact on daily life, and the urgency around developing therapies. Register to attend.
NASH Congressional Briefing
Last month, the American Association for the Study of Liver Diseases (AASLD) and Global Liver Institute (GLI) led a virtual briefing focused on establishing a national strategy to advance the prevention, treatment, and diagnosis of NASH. Moderated by AASLD President Raymond T. Chung, MD, FAASLD and Donna Cryer, JD, CEO and Founder of GLI. Watch the recording.
Global Liver Institute Applauds Congresswoman Velázquez and Senator Duckworth for Bold Action on Liver Health
Global Liver Institute applauds the actions of U.S. Representative Nydia Velázquez (D-NY) and U.S. Senator Tammy Duckworth (D-IL) to improve the lives of all people impacted by liver disease with the introduction of the Liver Illness, Visibility, Education and Research Act (LIVER Act) in the U.S. House of Representatives and the U.S. Senate, as well as the Recognizing October 2021 as Liver Cancer Awareness Month Resolution in the House. To reach out directly to your member of Congress and ask them to become a cosponsor of the LIVER Act, please click here.
GLI President and CEO Donna Cryer authors article for new Health Affairs Blog short series, “Value Assessment: Where Do We Go Post-COVID?” Cryer’s article, The Future Of Value Assessment In A Post-Pandemic United States, focuses on how we think about value in health care going forward and how these ideas might translate into policy. “If we learn the right lessons from the COVID pandemic, the future of value assessment will be one that highly values people with—and without—serious, chronic conditions or disabilities as essential members of society.”
Bosses Wear Burgundy Join Global Liver Institute in demonstrating your support for patients and families affected by liver disease around the world. To honor the millions of people worldwide living with liver disease post a picture of yourself on social media, wearing a burgundy tie, shirt, or scarf, using #BossesWearBurgundy, and invite others to join you in demonstrating your support for patients and families affected by liver disease around the world.
Leadership in Liver Health Awards and Luncheon On October 6, GLI held its inaugural Leadership in Liver Health Luncheon and honored Nicole Golden, DNP, FNP-BC, Veronica Roye, DNP, FNP-BC, and Monica Nelson-Kone, BSN, RN, the team behind the Black Liver Health Initiative at New York-Presbyterian, with the GLI Health Equity Award. Their team has done tremendous work in enhancing engagement with the Black community through building awareness, increasing access, and advancing transplant care. Thanks to our partners and sponsors, we raised crucial issues in liver health and showcased successes in improving the lives of those living with liver disease.
Julia Wattacheril, MD, MPH, Veronica Roye, DNP, FNP-BC, Nicole Golden, DNP, FNP-BC, Donna Cryer, JD, and Rev. Thomas L. Bowen.
GLI Live GLI Live has returned! Join Global Liver Institute President and CEO, Donna Cryer in conversation with global 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 every Wednesday at 12 pm ET.
Upcoming GLI Events
November 4, 2021: NASH Externally-Led Patient-Focused Drug Development (EL-PFDD) Symposium. Register now
Patient Advocacy – Navigating an Unfamiliar System
John M. is a patient and advocate for thousands of patients, who like him, have suffered from the burden of GI disease. His journey began at the age of 18 with a gallbladder attack, which ultimately led to a diagnosis of chronic pancreatitis. In 2013, he underwent a total pancreatectomy with auto-islet transplant. While the procedure saved his life, he understood the potential for liver complications to arise from being placed on total parenteral nutrition (TPN). Further complications and additional tests later revealed that John was suffering from NASH and the early stages of cirrhosis. “While I was well-versed in pancreatic and motility disorders, I shrugged this off as being ‘not a big deal’, not having known much about the liver at that point in time.”
After attending his first medical conference in 2017, John built relationships that helped him understand what he was going through and developed a newfound passion for advocacy and enrolled in GLI’s Advanced Advocacy Academy (A3). Since then, John has dedicated his time to raising awareness and advocating on behalf of patients like him. “If I’m only able to accomplish one goal as a patient advocate, it would be ensuring that the system is cognizant of the patient with no healthcare experience who is struggling to navigate an unfamiliar system.”
Community Liver Alliance GLI is pleased to welcome Community Liver Alliance as one of the newest members of the GLI NASH Council. Community Liver Alliance is dedicated to transforming the future of liver disease by sharing best practices and driving the implementation of knowledge. They unite patients, providers, and industry to deliver the best possible care and develop new, scalable solutions to the growing worldwide issue that is NASH.
Research & Development
Artificial Intelligence in Nonalcoholic Fatty Liver Disease: A New Frontier in Diagnosis and Treatment
The lack of efficient screening methods paired with showing no symptoms makes it difficult to properly identify patients with NAFLD. The rise of artificial intelligence (AI) in medicine may solve this problem by identifying patients with explicit and implicit risk factors for NAFLD as well as assessing the severity of NASH and advanced fibrosis. While there are few studies that have demonstrated its utility, there is a promising future for AI becoming increasingly relevant in the diagnosis and management of NAFLD and NASH.
Utility of Fibroscan XL to Assess the Severity of Non-Alcoholic Fatty Liver Disease in Patients Undergoing Bariatric Surgery
A recent study shows the Fibroscan with XL probe is a useful tool to assess NAFLD and NASH in bariatric surgery patients with obesity and can be performed reliably and safely both pre-and post-surgery. Fibroscan had previously been considered difficult to use in morbidly obese populations and produced unreliable results in up to 50% of patients, but the XL probe has demonstrated high success rates. Additionally, this study showed substantial improvements in reducing hepatic steatosis and fibrosis in patients who underwent bariatric surgery in conjunction with significant weight loss indicating the potential for reversing NAFLD. Read the study
GLI NASH Resources
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.
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.
The most recent module shared online focuses on making the diagnosis of NASH and features Wing-Kin Syn, MBChB, PhD, FACP, FRCP, as the module presenter. NASH Core Curriculum is supported by educational grants from Gilead Sciences and Novo Nordisk.
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.
U.S. NASH Action Plan: Recommendations for Medical Societies
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. This month, we’re highlighting some of the recommendations for patient advocacy organizations:
Education: Participate in conferences and educational fora to articulate patient experiences and expectations in NASH.
Diagnosis: Participate in and support research in non-invasive diagnostics and biomarker validation initiatives.
Patient Management/Treatment: Engage in collaborations with medical societies, health systems, and payors on the development of patient-centered care pathways, integrated care delivery models, guidelines, and quality measures.
Policy Effort/Legislation: Advocate for the establishment of a Federal strategy for preventing, diagnosing, and treating NASH through supporting the NASH Care Act (H.R. 8658).
Surfing the NASH Tsunami
Catch the latest episodes of Surfing the NASH Tsunami podcast, which regularly features guest appearances by GLI staff such as Donna Cryer, GLI President and CEO; Andrew Scott, GLI Director of Policy; Jeff McIntyre, NASH Program Director; and Livia Alimena, EU Office Director.
Clinical Care
FDA Grants Marketing Authorization to Siemens Healthineers ELF Test for NASH Prognostic Assessment
Despite the liver biopsy being the current standard for liver disease diagnosis, it often comes with complications and may miss advanced disease detection. The FDA has granted clearance to a blood test called the Enhanced Liver Fibrosis (ELF™) test that measures three bloodborne indicators of liver scarring to help diagnose mild-to-moderate liver fibrosis. The ELF test can help assess the likelihood of progression to cirrhosis in patients with advanced fibrosis due to NASH. Read about ELF
AGA releases NAFLD/NASH Clinical Care Pathway
The American Gastroenterological Association worked with other professional societies, including the American Diabetes Association, American Osteopathic Association, Endocrine Society, and the Obesity Society, to develop a NAFLD/NASH Clinical Care Pathway that the groups say will facilitate “value-based, efficient, and safe care that is consistent with evidence-based guidelines, and setting the stage for future studies to examine the outcomes of such pathways.”
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.
October is Liver Cancer Awareness Month. This represents an opportunity to draw attention to the global burden of liver cancer and to highlight the various public health organizations, scientific societies, and individuals making liver cancer awareness and education a priority.
Throughout the decades liver cancer has continued to rise, pushing it to now become one of the leading causes of death and illness worldwide. According to the World Health Organization (WHO) there were 905,677 new cases and 830,180 deaths from liver cancer in 2020 alone. 72.5% of new liver cancer cases were in Asia, especially in countries such as Mongolia and China where rates are 10-20 times higher than those in the United States. Globally, exposure to viral hepatitis and aflatoxin are the biggest risk factors for developing liver cancer.
The Centers for Disease Control and Prevention (CDC) is proud to be among the organizations working around the world toward the goal of increasing early detection and screening. CDC has created various programs in response to the increasing incidence of liver cancer. These include:
Promoting hepatitis B and hepatitis C screening, testing, and treatment. According to the CDC 78% of global hepatocellular carcinoma has been attributed to chronic HBV or HCV infection.
Developing, implementing, monitoring, and evaluating various hepatitis related policies and programs to address underlying causes of viral hepatitis transmission and outbreaks with the hopes of reducing liver cancer incidence rates.
Actively working to prevent and improve outcomes associated with liver cancers by raising awareness amongst at-risk communities and addressing the root causes and risks associated with this disease.
Implementing targeted liver cancer education and prevention efforts among health care providers and community coalitions especially within American Indian and Alaska Native communities. Liver cancer incidence rates were between 50% to over 3 times higher for American Indian/Alaska Native males and females compared with the white population.
In 2020, CDC published an augmented report on their recommendations for hepatitis C screening amongst adults. This report provides important details on preventative recommendations, services, and interventions to reduce HCV infections and the link of HCV and liver cancer. In 2019, the CDC published a report on Liver Cancer Incidence in the American Indian and Alaska Native Population in the United States from 2012 to 2016. In 2018, CDC reviewed the literature and cancer plan activities in the National Comprehensive Cancer Control Program, along with releasing a report surfacing the trends in Liver Cancer Mortality in the United States.
CDC is pleased to be working with many partners towards increasing early detection and screening of liver cancers. To learn more about our activities visit our website. We thank you for your continued support for CDC’s goals on Liver Cancer Awareness Month.
Lisa C. Richardson, MD, MPH
Director, Division of Cancer Prevention and Control
National Center for Chronic Disease Prevention and Health Promotion
On November 4th at 10 AM ET, Global Liver Institute led an Externally Led Patient-Focused Drug Development Meeting on NASH for the FDA. This online event is open to the public with registration required.
Up to 444 million people worldwide, including 40 million in the United States, are estimated to be living with the progressive, chronic liver condition nonalcoholic steatohepatitis (NASH), the advanced form of fatty liver disease (NAFLD). Current estimates show that more than 1 in 4 adults have NAFLD, and up to 6% have NASH. Yet, these conditions are under recognized, under diagnosed, and undertreated.
There are several reasons people may develop NASH including genetic predisposition and the presence of metabolic disorders, obesity, diabetes, chronic kidney disease, and cardiovascular disease. NASH is projected to rise in parallel to these diseases and to increase in prevalence by over 50% by 2030.
With these harrowing statistics in mind, we are excited to work with the liver advocacy community and invite you to join the first NASH EL-PFDD. 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 NASH, including their perspectives on their condition, its impact on daily life, and the urgency around developing therapies.
Have you been impacted by NASH? The Liver Action Network and GLI urge you to help to educate the medical community about the priorities and preferences for addressing NASH by participating in this important EL-PFDD NASH survey. Data collected in this survey will only be shared in an anonymized fashion and the survey organizers will not contact you about your responses.
The NASH EL-PFDD Meeting is a critical first step in providing the medical community with a deeper understanding of NASH directly from the patients and caregivers that have been impacted most. In case you missed it, watch it below:
Our Agenda:
10:00 a.m. – 10:10 a.m. Welcome, Opening Remarks & Introductions Donna Cryer, CEO and Founder of Global Liver Institute
10:10 a.m. – 10:15 a.m. EL-PFDD Overview and FDA Role Director Joe Toerner, Division of Hepatology and Nutrition
A 27-year liver transplant recipient, Cryer said “Through both of your leadership, and the reintroduction of the the Liver Illness, Visibility, Education and Research Act (LIVER Act) in the U.S. House of Representatives and the U.S. Senate, as well as the Recognizing October 2021 as Liver Cancer Awareness Month Resolution in the House, we can move the field forward and shift the conversation to shine a spotlight on liver cancer, and liver cancer health disparities.”
The need for urgent Congressional action becomes evident when we consider that since 1980 the incidence of liver cancer in the United States has tripled, and death rates have nearly doubled.
These concerns are further amplified when we consider the enduring racial and ethnic liver cancer health disparities that we have sought to eliminate for years, including:
Asian Americans are four times more likely to have liver cancer than any other ethnic population;
Excess liver cancer incidence and liver cancer mortality are highest among non-Hispanic Black males versus other races;
U.S. Hispanics have a liver cancer incidence rate that is almost two times higher than non-Hispanic whites;
Asian Americans comprise 60% of the U.S. population living with Hepatitis B, the leading risk factor for liver cancer;
American Indian/Alaskan Natives have a liver cancer mortality rate almost two times higher than non-Hispanic whites
Liver cancer disparities reflect the interplay amongst many factors, including social determinants of health, behavior and genetics. Yet, according to the American Cancer Society, up to 70% of liver cancer cases could be prevented by increased uptake of hepatitis B vaccination, hepatitis C cures, and lifestyle management and development of treatments for fatty liver disease. The LIVER Act, and the resolution, rightfully act as a crucial first step towards addressing many of these factors.
With the reintroduction, and introduction of these important pieces of legislation, we now need your help to urge other Members of Congress to cosponsor each of these bills, urge action on each within Congressional committees, and support their inclusion in other legislation. We also encourage you to sign and share GLI’s Liver Cancer Call To Action, pledging support to double the five-year survival rate for liver cancer.
About Global Liver Institute
Global Liver Institute (GLI) is the only patient-created and patient-driven nonprofit organization tackling liver health and all liver disease holistically. Rooted 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, equipping advocates to improve the lives of individuals and families impacted by liver disease. Follow GLI on Twitter, Facebook, Instagram, LinkedIn, and YouTube.
