Advocacy with Integrity
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.
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Advocacy with Integrity
As we collectively work to elevate the level of advocacy in NASH we must be mindful to conduct ourselves with integrity.
This month will mark the 25th year since my life-saving liver transplant. I have spent 23 of those 25 years in some form of advocacy role – being one half of the federal affairs team for UNOS on organ transplant policy, helping companies establish their DC offices as a consultant, advising patient groups and medical societies on how to be more effective in getting their voices heard and issues addressed. Some of my achievements that I know have had the most impact on people’s lives (isn’t that how we should measure effectiveness) occurred while I was representing the interests of transplant recipients, oncology patients, or the patients as a whole in creating greater roles for engagement to Congress or regulatory agencies.
We have an incredible opportunity in NASH advocacy to finally lift liver health issues onto the public health agenda in a way that it has never been done before, but all our efforts will be undermined if they are conducted in a way that lacks the components of integrity as I know them to be: truth and accuracy, transparency, representativeness, and both urgency and persistence. These are the principles that GLI uses to guide its activities and what we teach our Advanced Advocacy Academy (A3) participants. We believe that these principles for conducting advocacy with integrity are what attract the more than 45 members of our NASH Council and Liver Cancers Council. Whether members come from patient groups, medical or nursing societies, research organizations, pharmaceutical companies, or government agencies they are treated with respect and led with integrity as we work together to elevate issues and address challenges.
We are proud to join with others who exemplify these principles such as the Obesity Action Coalition, the Personalized Medicine Coalition, Research!America, and many others.
GLI encourages all those you would conduct advocacy with integrity to join us and become a member of the NASH Council today!
Donna R. Cryer, JD
President & CEO
Global Liver Institute
International NASH Day: Building on Our Successes
International NASH Day was held on June 12, under the leadership of GLI, gathering together more than 65 partners worldwide and successfully launching events and screenings, briefings, media outreach, and social media campaigns globally. Next year’s International NASH Day will again be held on June 12, with the goal of raising awareness about NASH and the actions people can take to prevent the disease. Read all about this year’s successes in our summary report here.
GLI Welcomes New NASH Program Director
GLI welcomes Jeff McIntyre as NASH Program Director. With over 20 years of public health and advocacy experience, Jeff has worked with leading local, national, and international organizations and companies to address public health and chronic disease. Through specializations in childhood obesity, nutrition, and physical activity, Jeff is GLI's key point person for coordinating and growing the organization's NASH initiatives through the NASH Council, International NASH Day, and Beyond the Biopsy campaign.
New Approaches to the Old Hunt for NASH Therapies: Webinar
Front Line Genomics hosted a panel discussion on New Approaches to the Old Hunt for NASH Therapies, moderated by GLI President and CEO Donna Cryer. The panel discussed why there has been limited progress in therapies for NASH and possible approaches for the future. The panelists pointed to the limited understanding of the underlying biology of NASH and stated that a back to basics approach was needed. As NASH is a complicated, multi-factor disease governed by multiple biological pathways, it was stressed that a one-target approach may not be that effective, highlighting the weakness in current therapies which are mainly repurposed diabetes and anti-inflammatory drugs with limited effectiveness.
GLI Celebrates National Obesity Care Week, September 15-21
GLI is a proud partner of National Obesity Care Week (NOCW), held this year from September 15-21. Founded in 2015, NOCW envisions a society that understands, respects, and accepts the complexities of obesity and values science and clinically-based care. NOCW aims to change the way obesity is cared for, by providing science and clinically-based education on obesity and advocating for access to affordable and comprehensive care. Obesity and diabetes are the two major causes of liver disease among people in the United States.
GLI Joins Digestive Disease National Coalition
GLI has joined the Digestive Disease National Coalition (DDNC), an advocacy organization comprised of the major national voluntary and professional societies concerned with digestive diseases. The DDNC focuses on improving public policy and increasing public awareness with respect to diseases of the digestive system. The DDNC’s mission is to work cooperatively to improve access to and the quality of digestive disease health care in order to promote the best possible medical outcome and quality of life for current and future patients.
Obesity and Diabetes-Related Liver Disease on the Rise in the U.S.
Obesity and diabetes are the two major causes of liver disease among people in the United States, according to a study published in the medical journal Gut. The study stated there is a 30 percent rise in Americans being diagnosed with non-alcoholic fatty liver disease (NAFLD) during the last three decades. The research looked into the various reasons for an increase in liver disease among Americans between 1988 and 2016, finding overweight and high blood sugar were the two main causes for it. The obesity rate was at an all-time high among Americans in 2016, with 93.3 million or almost 40 percent of Americans affected by obesity during this period.
NAFLD in Lean Patients
Although NAFLD commonly develops in people affected by obesity, many lean individuals develop the disease, and tend to have worse outcomes compared to patients affected by obesity. Researchers from the Westmead Institute for Medical Research (WIMR) studied how NAFLD develops in lean people. The researchers compared the metabolism, gut bacteria, and genetic profiles of patients with lean and non-lean NAFLD to determine factors that contribute to disease development and progression.Their findings suggest that lean patients with a fatty liver may have an “obesity-resistant” profile, and better adaptation to an excess intake of calories. This profile, however, does not protect them from liver fat accumulation.
NAFLD and NASH in Type 2 Diabetes Patients
Adults with Type 2 Diabetes and higher C-peptide levels are more likely to develop NAFLD and NASH compared with those with lower levels, according to findings published in Diabetes Metabolism Research and Reviews. The C-peptide, or connecting peptide, a short 31‐amino‐acid polypeptide, is one of the segments of proinsulin that connects insulin's two chains.
Genomic Study of Type 2 Diabetes in Sub-Saharan Africans
National Institutes of Health researchers have reported the largest genomic study of type 2 diabetes (T2D) in sub-Saharan Africans, with data from more than 5,000 individuals from Nigeria, Ghana, and Kenya. Researchers confirmed known genomic variants and identified a novel gene ZRANB3, which may influence susceptibility to the disease in sub-Saharan African populations. The gene could also influence the development of T2D in other populations and inform further research.
Report on Released on Economic Impacts of NAFLD and NASH
Dr. Stephen A. Harrison, MD, visiting professor of hepatology at the University of Oxford and medical director at Pinnacle Clinical Research, discussed how the growing epidemic of liver disease impacts the financial solvency of the U.S. healthcare system in a white paper released by Echosens. Data from “The Economic Tsunami of Liver Disease” revealed that nonalcoholic fatty liver disease, which affects approximately 100 million Americans, costs the U.S. healthcare system $32 billion annually, compared with the $34 billion annual costs of strokes.
Beyond the Biopsy
FDA Awards Breakthrough Device Designation to Noninvasive Test
The U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation to a Liquid Biopsy Liver Cancer Detection Test being developed by Laboratory for Advanced Medicine (LAM), a commercial-stage medical technology company. LAM’s liver cancer test provides patients with cirrhosis an accurate, noninvasive tool to detect the presence of liver cancer before it becomes life-threatening.
NASH Council Members in the News
GENFIT Announces New CEO
GENFIT announced that its board of directors has appointed Pascal Prigent, GENFIT’s Executive Vice President of Marketing and Commercial Development, as Chief Executive Officer, following the recommendation of Jean-François Mouney, who will remain Chairman of the Board.
Intercept Releases Study on NASH Amid Website Launch
Intercept Pharmaceuticals announced the launch of NASHTRUTH.com, a new online educational resource for people with advanced fibrosis due to NASH.The website includes findings from a survey conducted by Intercept, which found that patients are much more likely to say there is not enough information regarding NASH (61%) compared to other conditions like obesity (30%) and type 2 diabetes (17%). Among those patients who have researched NASH, more than half (54%) rated the quality of available information about NASH as fair or poor.
Liver Policy Update
Court Case Continues over Organ Transplant Policy Change
An 11th circuit court panel heard arguments over a proposed policy change that would affect how patients on the liver transplant waiting list receive their transplants. The plaintiffs in the case, which include four patients who are currently on the waiting list and multiple hospitals that operate liver transplant programs, filed suit in Georgia federal court in April seeking to block the implementation of the new organ allocation policy. In their original complaint, the plaintiffs accused the U.S. Department of Health and Human Services (HHS) of failing to follow “legally required procedures in developing the policy, instead choosing to defer virtually all decision-making to a private government contractor,” in this case the nonprofit United Network for Organ Sharing.
NIH Announces Initiative to Modernize Clinicaltrials.gov
The National Institutes of Health (NIH) has announced a proposal which includes establishing a working group of the National Library of Medicine (NLM) Board of Regents to focus on the modernization of ClinicalTrials.gov. This working group will provide a transparent forum for communicating and receiving input about efforts to enrich and modernize ClinicalTrials.gov, the largest public clinical research registry and results database in the world.
Diabetes A Predictor of Advanced Liver Disease
For the 6.65 million adults who live with NASH in the U.S., lifetime costs for all NASH cases in 2017 were $222.6 billion and the cost of advanced NASH was $95.4 billion.
WHO Regional Committee for Europe, 69th Session, September 16-19, Copenhagen
International Liver Cancer Association Annual Meeting September 20-22, Chicago
EASL - NAFLD Summit September 26-29 (Valencia, Spain)
European Society for Medical Oncology Congress September 27 - October 1 (Barcelona, Spain)
3rd NASH Summit EU October 23-25 London
NCI Liver Cancer Program: Special Conference on Tumor Metabolism October 28-29, Bethesda
Global Liver Institute Advanced Advocacy Academy, November 1-2, Washington
American Public Health Association November 2-6, Philadelphia
American Association for the Study of Liver Disease,The Liver Meeting November 8-12, Boston