July NASH News
Fatty liver disease (FLD) and non-alcoholic steatohepatitis (NASH) are increasing in prevalence worldwide, creating a major global public health crisis. To adequately educate patients, practitioners and policy makers, 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
GLI Perspective
International NASH Day 2019: A worldwide effort; a worldwide success
On June 12, scores of partnering organizations, sponsors, and individual patients, physicians, and liver health advocates came together to make the second annual International NASH Day a huge success. From Bangladesh to Belgium, Mexico City to Moscow, we launched events in our communities and made important strides in raising awareness of the disease. With 60 events in 22 countries -- from 65 partners worldwide -- we marked International NASH Day as a day of impact and action.
The day saw extensive outreach from GLI’s Advanced Advocacy Academy (A3) alums, including Kimberly Martinez’s participation in a Facebook Live event on patient and provider perspectives on NASH, Wayne Eskridge’s (Fatty Liver Foundation) joint appearance with me on a radio tour, and Anthony Viliotti’s screening of his documentary The Silent Epidemic: the liver disease NASH.
Policy initiatives included a briefing on NASH on Capitol Hill in Washington, DC, attended by many Congressional staffers. GLI European Director Livia Alimena appeared on a panel in Moscow with Russian Deputy Health Minister Dr. Oleg Salagay.
Partners around the globe rallied around social media with the hashtag #NASHday, with 2.79 million impressions. GLI engaged in multi-media and multi-channel communications, from Facebook Live with more than 3,000 views, to a promoted article in English and Spanish that ran in more than 2,000 publications (see map showing the article placements across the US). The article included mention of our Beyond the Biopsy™ campaign promoting noninvasive diagnostic alternatives to biopsy. Finally, GLI launched a #smashNASH campaign on Twitter, which represents our attitude on ending this disease.
Global Liver Institute looks forward to next year’s International NASH Day, June 12, 2020. We welcome your ideas and suggestions. With continued support from the liver health community, we expect 2020 to be even bigger and better.
Donna R. Cryer, JD
President & CEO
Global Liver Institute
Progress On Nash Council Policy Agenda
The Liver Illness Visibility, Education and Research (LIVER) Act of 2019 (HR 3016)
GLI has been actively involved in promoting legislation to increase investments in research, prevention, and awareness about liver disease and liver cancer, whose prevalence continue to increase. On July 9th, GLI officially submitted a letter of support to Representative Nydia Velazquez (D-NY). Read what The LIVER Act will do
Included in our letter of support, GLI made the specific ask that as the bill advances to add NASH to the already included list of conditions known to increase an individual’s risk of developing a major liver disease.
U.S. Senator Todd Young (R-IN) Introduces Legislation to Bring Greater Accountability to Organ Donation System
On July 9, 2019 Senator Young introduced legislation that aims to deliver more life-saving organs to patients by establishing clear, accountable metrics for organ procurement organizations (OPOs). As a reminder, on March 12th, GLI submitted a letter to CMS Administrator Seema Verma asking CMS to substitute the metrics by which Organ Procurement Organizations are evaluated for a new verifiable metric that is not open to self-reported interpretation.
The Trump Administration Announces a Series of Initiatives Focused on Organ Transplantation
Many of the initiatives in the July 10th administration announcement are designed to encourage more kidney transplants and treatment at home, thus starting a process intended to overhaul a market in which the federal government spends more than $100 billion per year. However, one key initiative, similar to Senator Young’s bill, is designed to boost all organ transplantation and crack down on Organ Procurement Organizations (OPOs). President Trump will order Secretary Alex Azar of HHS to develop better ways of measuring OPO performance that are clearer, more reliable, and easier to enforce.
Another planned Trump proposal would increase payments to live donors of kidneys and livers to cover more of their expenses, possibly including lost wages and child care. GLI will continue to be actively involved, and keep our fingers on the pulse of these important issues. We will update the liver health advocacy community as events are planned or occur.
NASH Council
Members
NASH Council members may access the report of the Council’s May 16, 2019 meeting. To access the report, go to www.globalliver.org/nash-council and visit the members’ portal. If you do not have the password, request it by emailing info@globalliver.org.
New Members
We welcome to the NASH Council Boehringer Ingelheim (BI), a family-owned global pharmaceutical company. BI has an active NASH clinical development program in progress.
Members in the News
Genfit is stepping up combination trials for its NASH candidate elafibranor, recognizing the challenges of treating this complex disease. The French biotech says it has identified multiple compounds that could be used alongside its lead drug – a dual PPAR alpha and delta agonist – which is already in a pivotal phase 3 trial called RESOLVE-IT due to generate results before the end of the year.
NASH POLICY
NASH in Europe and the Middle East
The Health Policy Partnership published “Creating a policy narrative around NASH in Europe and the Middle East,” which aims to prompt a measured policy response to the anticipated rise of NASH in years to come. Focused on Europe and the Middle East, it offers up-to-date estimates of the epidemiology and impact of NASH, and highlights key strategic issues to improve clinical management and health system preparedness from a policy perspective.
Awareness, Knowledge Shape Organ Donation Decisions
A survey released by WebMD and the University of Pittsburgh Medical Center revealed that lack of awareness, misperceptions, and biases about liver disease and transplantation, especially living donation, are significant factors contributing to a lack of available organs. Among surveyed patients with liver disease, only 10% learned about living donation from their physician, and approximately 43% of physicians reported a lack of knowledge regarding living-donor liver transplantation. By 2020, NASH is expected to be the number one cause of liver transplantation.
Patient Insights
A highlight of GLI’s 2018 Advanced Advocacy Academy occurred when Steve Scheier spoke movingly of his wife Amy’s bile duct cancer diagnosis and her decision to not be told of her prognosis, specifically the words about how long she could expect to live. In the following years, Amy was both treated and lived and enjoyed her life. She did not ask for her prognosis until she felt it was time, shortly before her death. Steve, an expert in organizational decision making, channeled his grief and used their experience to help other patients control the information they would receive by creating a “Prognosis Declaration.” His tool, a simple form, helps patients articulate what information should be shared with whom and when. Read about this movement to enable patients to control the information they and their loved ones or caregivers are presented in a recent opinion column titled “Don’t Tell Me When I’m Going to Die.” Also, look for Steve’s chapter on the Prognosis Declaration in a book to be published by Simon and Schuster by mid-July 2019, “A Beginners Guide to the End, Practical Advice for Living Life and Facing Death.”
Clinical Perspectives
Even Before Medications, It Is Time to Act on NAFLD Now
“Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention,” published in Nature, highlights NAFLD as one of the most important causes of liver disease worldwide. The authors argue that while awaiting the development of effective treatments, NAFLD warrants the attention of primary care physicians, specialists, and health policy makers.
Should Hepatology or Primary Care Treat Fatty Liver Disease?
The article makes the case for care by each physician type and also for collaborative care.
Research
Diabetes A Predictor of Advanced Liver Disease
Risks and clinical predictors of cirrhosis and hepatocellular carcinoma diagnoses in adults with diagnosed NAFLD, a study of 18 million patients in four European cohorts, found diabetes to be an independent predictor of advanced liver disease diagnosis, emphasising the need to identify specific groups of patients at highest risk.
European Registry Study 2002-2016: NASH Drove Transplant Increases
NAFLD Research Focuses on the Gut Biome
NASH, NAFLD Awareness Remains Low Even Among High Risk Groups
Results from a survey presented at the third annual NASH Summit in Boston by Continuum Clinical showed that awareness of nonalcoholic steatohepatitis and nonalcoholic fatty liver disease remained low even among patients with the highest risk factors. Among patients with comorbidities such as type 2 diabetes, obesity, and hypertension, only 6% had ever heard of NASH.
Regulatory News
FDA Guidance
Although there is not yet any Food and Drug Administration (FDA)-approved drug for treating nonalcoholic steatohepatitis, the agency issued draft guidance for companies developing drugs among NASH patients with cirrhosis who do not yet display symptoms. The draft guidance, “Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment,” was announced in the Federal Register on June 7. Public comment is being accepted through August 6. This draft guidance accompanies a draft guidance issued last year for NASH with liver fibrosis, but without cirrhosis. Stay tuned for information regarding GLI’s comment to the FDA.
Book Chapter Addresses Clinical Development Regulatory Guidelines
GLI board member, Dr. Brian E. Harvey, literally wrote the book on NASH regulatory science. In Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease, the chapter “Regulatory Considerations for Early Clinical Development of Drugs for Diabetes, Obesity, Nonalcoholic Steatohepatitis (NASH) and Other Cardiometabolic Disorders” is written by G. Alexander Fleming and Brian E. Harvey. The chapter supplements available published and web-based resources that describe current regulatory expectations and requirements for diabetes, anti-obesity and lipid-lowering therapies.
Beyond The Biopsy
The Forum for Collaborative Research announced publication of a new article, Defining Improvement in Nonalcoholic Steatohepatitis for Treatment Trial Endpoints: Recommendations from the Liver Forum, in the peer-reviewed journal, HEPATOLOGY. The paper is a review of where the field is now in our understanding of blood tests, imaging tests and functional testing of the liver and how these measure change with treatments of NASH.
Upcoming Meetings
July 26-27, 2019, 7th Annual International Conference on Nutrition in Medicine, Washington, DC
September 19-20, 2019, The Liver Forum, Bethesda, MD
September 26-29, 2019, EASL, NAFLD Summit 2019, Valencia, Spain
November 1-2, 2019, Global Liver Institute Advance Advocacy Academy, Washington, DC
November 2019, AASLD, The Liver Meeting 2019, Boston, MA
Fast Nash Facts
From 2000 to 2015, death rates for chronic liver disease and cirrhosis in the United States increased 31% (from 20.1 per 100,000 to 26.4) among persons aged 45–64 years.