Donna Cryer, Founder and CEO, Global Liver Institute
Public Witness Testimony
U.S. House of Representatives, Appropriations Committee, Subcommittee on Labor, Health and Human Services and Related Agencies (Labor/HHS)
March 23, 2023
Thank you, Chairman Aderholt, Ranking Member Delauro, and Members of the Committee for this opportunity to provide public witness testimony as you and your staff begin work on drafting the Labor/HHS Appropriations bill and its accompanying Explanatory Statement. My name is Donna Cryer and I founded and serve as the CEO of the Global Liver Institute. We are the leading global liver patient advocacy organization representing the over 100 million people in the United States with liver disease, the additional 25,000 men and 11,000 women who get liver cancer each year, and the 19,000 men and 9,000 women who die from it each year.
I am here today due to the concerns of the liver disease community about the senseless rising incidence of liver disease and liver cancers when measures to prevent, diagnose, and treat liver disease and liver cancer are available. As appropriators, you can invest in the tools to reduce liver disease and liver cancer, including for the 10 percent of children with Nonalcoholic Steatohepatitis (NASH), for the non-Hispanic blacks for whom liver disease is the ninth leading cause of death, and for the African American/Black men who are 60 percent more likely to have — and to die from — liver and Intrahepatic Bile Duct (IBD) cancer.
People with liver diseases too often go on to have liver cancer. Eradicating liver disease would reduce liver cancers which are among the cancers on the rise — not falling. Liver cancer is not identified among the Centers for Disease Control and Prevention’s (CDC) Cancer Programs. Liver disease research falls under the National Institutes for Diabetes and Digestive and Kidney Diseases, yet it is not given sufficient attention. The National Cancer Institute does not prioritize liver cancer research; yet, we know the most efficient and effective way to reduce cancer and work toward the Cancer Moonshot would be to address the liver disease that is associated with increasing numbers of people in the United States with liver cancer. So, what can you do?
Address the Looming Epidemic of Nonalcoholic Steatohepatitis (NASH)
We urge the Committee to explicitly recognize the increased risk of nonalcoholic fatty liver disease progressing to nonalcoholic steatohepatitis, also known as NASH, that researchers have recognized to be at risk of becoming an epidemic.1 By most recent estimates, up to 444 million people worldwide and 40 million in the United States are living with NASH.2 Plus, an estimated 10 percent of children in the United States also currently have NASH.3, 4, 5 This disease disproportionately impacts people in America facing the challenges presented by social determinants of health putting them at increased risk. Experts predict NASH could increase by over 50 percent by 2030.6 Twelve percent of people with NASH will go on to have liver cancer. Chronic liver failure due to cirrhosis is the most common reason for liver transplantation and 20 percent of individuals with NASH progress to advanced fibrosis and cirrhosis caused by NASH.
NASH is closely associated with obesity, diabetes, chronic kidney disease, and cardiovascular disease (CVD) and is projected to rise in parallel to these diseases.7 It has a bidirectional relationship with type 2 diabetes. If NASH develops first, the patient is likely to develop type 2 diabetes. In patients with type 2 diabetes initially, NASH is a common comorbid occurrence (37 percent of people with type 2 diabetes have NASH).8 Diabetes contributes to a faster fibrosis progression of NASH and can accelerate the progression to cirrhosis and liver cancer.9 This condition has significant implications for people and their quality of life, as well as our health system. The rise in prevalence of NASH, its complications, and its comorbidities carry significant economic costs. Costs associated with NASH include inpatient, outpatient, professional services, emergency department, and drug costs.10 Furthermore, comorbidities contribute not only to costs in healthcare spending but also to indirect costs, such as lost work productivity.11
If diagnosed, we know lifestyle interventions applied early in the disease progression can impact NASH and even reverse the disease.12 In addition, new treatments for NASH approved by the Food and Drug Administration (FDA) will finally provide NASH patients with access to therapies to stop disease progression or even reverse it. Yet, clinicians are often not trained to diagnose NASH early nor is our health system supporting early diagnosis.
Systematic progress in preventing, diagnosing, and treating NASH and its associated liver cancers is needed. This will require prioritizing attention to public awareness, dissemination of more accessible diagnostic solutions, implementation of evidence-based programs to address nutrition and exercise, uptake of new treatments approved by the FDA, and research to understand the condition and ensure clinical guidelines represent real solutions.
Advance the Hepatitis C Elimination Program
There is little justification for the increasing rates of hepatitis C in this country. It is a disease that can be prevented, diagnosed, and cured. With a positive test, treatment to cure the disease can start that very day with a simple pill taken for 8-12 weeks and delivered with a prescription from a primary care doctor. Yet, 40 percent of the 2.4 million people13 living with hepatitis C are unaware of their infection despite the routine and broad screening that has been recommended for every person over 18 and the curative oral agents that are available.14
Therefore, I hope this Committee will fully fund the elements of the President’s proposed Hepatitis C Elimination Program that fall under its jurisdiction. Keep in mind that 50 percent of liver cancer is related to hepatitis C,15 making the Hepatitis C Elimination Program an efficient and effective way to get to the goal of the President’s Cancer Moonshot. If we cure the 2.4 million people in America that have hepatitis C, we could reduce liver cancer by 1.2 million.
Vaccinate for Hepatitis B
Hepatitis B affects approximately 296 million people, including over 6 million children under age 5. Yet, hepatitis B vaccines are recommended by CDC for everyone under age 60 and at-risk individuals over age 60.16 The U.S. Preventive Services Task Force only recommends screening for hepatitis B virus (HBV) infection in adolescents and adults at increased risk for infection.17 This inconsistency is problematic knowing that liver cancer is associated with hepatitis B in 15 percent of cases. Raising awareness about the CDC’s recommendations for vaccination and getting every person vaccinated could eliminate 44 million future cases of liver cancer.
Direct Funding to Agencies to Address Liver Disease and Liver Cancer
Centers for Disease Control and Prevention, Division of Viral Hepatitis
While any increase in funding is appreciated, the $2 million increase to the Division of Viral Hepatitis in fiscal year (FY) 2023 was not nearly the $13 million increase requested in the President’s budget and was a fraction of the $140 million requested in FY 2023 by the hepatitis C community to fully fund efforts to eliminate viral hepatitis. Therefore, we hope that the Committee will go beyond the President’s budget request of a $9 million increase funding to the Division of Viral Hepatitis ($52 million) and fund the department at the $150 million level.
Centers for Disease Control and Prevention, Cancer Programs
Liver cancer is the only cancer that is growing, while others are stabilizing or reducing. Yet, there is no dedicated program at the CDC for liver cancer. We strongly support the President’s budget calling for $1 billion to the CDC for cancer programs — almost doubling the budget. We urge funding to the CDC’s Cancer Programs directed specifically to addressing liver cancer.
National Institutes of Health, National Cancer Institute (NCI)
The President’s budget calls for an increase of $500 million to the National Cancer Institute, totaling $7.8 billion. We hope that Congress will, at a minimum, fully fund the President’s budget request and explicitly call on NCI to increase its attention to liver cancer, its causes, and preventive measures and support innovation in its treatment.
National Institute of Health, National Institute for Diabetes and Digestion and Kidney Diseases (NIDDK)
We have long advocated for increased funding for liver disease research. I urge the committee to not only fully fund the President’s budget for NIDDK, but to provide increased funding and direct the NIDDK to increase funding for liver disease research.
In closing, thank you for this opportunity to provide public witness testimony. It is a rare opportunity to share with you the reality of the burden experienced by liver disease and the cost of these diseases for society and our health system, especially in light of its progression to costly liver cancer and liver transplants.
1 Kanwal, Fasiha et al. “Preparing for the NASH epidemic: A call to action.” Metabolism: clinical and experimental vol. 122 (2021): 154822. doi:10.1016/j.metabol.2021.154822
2 Spengler, Erin K, and Rohit Loomba. “Recommendations for Diagnosis, Referral for Liver Biopsy, and Treatment of Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis.” Mayo Clinic proceedings vol. 90,9 (2015): 1233-46. doi:10.1016/j.mayocp.2015.06.013
3 Welsh, Jean A et al. “Increasing prevalence of nonalcoholic fatty liver disease among United States adolescents, 1988-1994 to 2007-2010.” The Journal of pediatrics vol. 162,3 (2013): 496-500.e1. doi:10.1016/j.jpeds.2012.08.043
4 Schwimmer, Jeffrey B et al. “Prevalence of fatty liver in children and adolescents.” Pediatrics vol. 118,4 (2006): 1388-93. doi:10.1542/peds.2006-1212
5 Fernandes, Danielle M et al. “Pediatric Nonalcoholic Fatty Liver Disease in New York City: An Autopsy Study.” The Journal of pediatrics vol. 200 (2018): 174-180. doi:10.1016/j.jpeds.2018.04.047
6 “The Language of Nash.” Https://Globalliver.org/Wp-Content/Uploads/2022/06/GLI_TheLanguageofNASH_270820.Pdf, The Global Liver Institute, Aug. 2020, https://globalliver.org/wp-content/uploads/2022/06/GLI_TheLanguageofNASH_270820.pdf.
7 Younossi, Zobair M et al. “Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes.” Hepatology (Baltimore, Md.) vol. 64,1 (2016): 73-84. doi:10.1002/hep.28431
8 Younossi, Zobair M et al. “The global epidemiology of NAFLD and NASH in patients with type 2 diabetes: A systematic review and meta-analysis.” Journal of hepatology vol. 71,4 (2019): 793-801. doi:10.1016/j.jhep.2019.06.021
9 McPherson, Stuart et al. “Evidence of NAFLD progression from steatosis to fibrosing-steatohepatitis using paired biopsies: implications for prognosis and clinical management.” Journal of hepatology vol. 62,5 (2015): 1148-55. doi:10.1016/j.jhep.2014.11.034
10 Younossi, Zobair M et al. “Burden of Illness and Economic Model for Patients With Nonalcoholic Steatohepatitis in the United States.” Hepatology (Baltimore, Md.) vol. 69,2 (2019): 564-572. doi:10.1002/hep.30254
11 Younossi, Zobair M et al. “The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe.” Hepatology (Baltimore, Md.) vol. 64,5 (2016): 1577-1586. doi:10.1002/hep.28785
12 “The Language of Nash.” Https://Globalliver.org/Wp-Content/Uploads/2022/06/GLI_TheLanguageofNASH_270820.Pdf, The Global Liver Institute, Aug. 2020, https://globalliver.org/wp-content/uploads/2022/06/GLI_TheLanguageofNASH_270820.pdf.
13 Stonehill, Monica. “’We Need Your Help’: AASLD Support, Outreach Key to Success of HCV Elimination Program.” Healio, 15 Nov. 2022, https://www.healio.com/news/gastroenterology/20221115/we-need-your-help-aasld-support-outreach-key-to-success-of-hcv-elimination-program.
14 “Testing Recommendations for Hepatitis C Virus Infection.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 29 July 2020, https://www.cdc.gov/hepatitis/hcv/guidelinesc.htm.
15 Viral Hepatitis and Liver Cancer. Centers for Disease Control and Prevention, Mar. 2016, https://www.cdc.gov/nchhstp/newsroom/docs/factsheets/viral-hep-liver-cancer.pdf.
16 “Hepatitis B Vaccination.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 30 Mar. 2022, https://www.cdc.gov/vaccines/vpd/hepb/index.html.
17 “Hepatitis B Virus Infection in Adolescents and Adults: Screening.” Recommendation: Hepatitis B Virus Infection in Adolescents and Adults: Screening | United States Preventive Services Taskforce, US Preventive Services Taskforce, 15 Dec. 2020, https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/hepatitis-b-virus-infection-screening.