Often in this space, we discuss the advocacy efforts of AASLD with regard to the Congress, focusing on important authorizing and funding legislation pending and our efforts to advance it for the benefit of liver patients and AASLD members. But enacting laws in only one part of the equation. Those laws must be implemented, which is the responsibility of the Executive Branch.
During December and January, AASLD leaders participated in virtual meetings with leaders in three NIH institutes and two federal agencies to discuss ways in which these agencies could help promote liver health in their respective areas of jurisdiction. The meetings were led by Drs. Laurie De Leve, Norah Terrault, and Raymond Chung from the AASLD Governing Board. The following is a brief summary of those meetings and some of the take-aways from them.
NIAAA: Dr. George Koob, NIAAA Director, provided his insight on the institute's efforts to reduce the public health burden of the overconsumption of alcohol, using technology including biomarker epidemiology. This led to a discussion of widening biomarkers for early alcohol damage detection. The Institute would welcome grant applications directed at biomarker discovery. Dr. Kathy Jung isthe NIAAA contact on this initiative. It was suggested that this is an area of potential collaboration with the Department of Veteran Affairs. It was also noted there has been support for biomarker research from the Foundation for NIH.
As there is not a core curriculum for medical schools regarding alcohol, Dr. Koob expressed his interest in developing one. It was suggested that this might be done in part with the Alcohol-associated Liver SIG. Other topics discussed were joint efforts with NIDDK on alcohol cohort studies and with the American Psychiatric Association (APA) to address addiction disorders.
NIAID: Dr. Hugh Auchincloss is the Principal Deputy Director of NIAID and a thoracic surgeon by training. The discussion focused on ways in which the scope of liver diseases particularly viral hepatitis and liver transplantation ties in with NIAID;s goal in addressing various diseases including immune-mediated disorders. This led to a conversation about the Hepatitis B Research program, and how focusing on basic and translational research to find a cure could be used as a guide to address other hepatitis viruses such as Delta.
The institute further discussed the intramural and extramural research they are currently undertaking. The NIAID intramural program is conducting basic and clinical research on hepatitis to develop strategies for diagnosis and treatment. The groups agreed on that AASLD should meet with the Center for Scientific Review to discuss the need for a hepatitis study section, and AASLD’s relevant SIGs (Hep B, C) should reach out to Dr. Rajen Koshy (Program Officer) for further interaction.
NCI: Dr. Doug Lowy, the Principal Deputy Director of the National Cancer Institute, met with the AASLD leadership to discuss their strong and growing support of liver cancer research, and how such research can help address hepatitis C and the development of an HCV vaccine. He stressed importance of treating people with HCV nationwide. It was agreed that this approach will help reduce HCV-associated liver failure among patients, and HCV-associated liver cancer cases across the nation. The issue in addressing HCV among patients is far beyond the providers. It lies with patients being uninsured or underinsured, leading to delays in treatment.
Dr. Lowy discussed an effort in 2019 and early 2020 to reduce HCV infection through inter-agency collaboration and a focus on treatment. HHS level meetings were held, but the effort was derailed by the pandemic. He indicated he would like to restart this effort. AASLD expressed strong interest in participating in these efforts.
CDC DVH: Dr. Carolyn Wester, the Director of Division of Viral Hepatitis at the CDC discussed the screening and testing guidelines for hepatitis B, and how routine universal screening can help with lessening viral hepatitis infections, as prevention (through vaccination and screening) is critically important until there is a cure.
The desire of the Division to work closely with AASLD was evidenced by their request to have a liaison serve on the Viral Hepatitis Elimination Task Force and be involved with the Hep B and C SIGs. The Director also supported the concept of holding more regular meetings at the Board and SIG levels.
FDA: Drs. Joe Toerner and Frank Anania from the FDA’s Division of Hepatology and Nutrition provided background on a recently convened panel by NIAAA (that includes FDA) evaluating how Alcohol Use Disorder (AUD) trials are managed and how clinical endpoints are addressed. The panel plans a workshop this summer to further discuss this issue. For trials evaluating alcohol associated liver disease and AUD, the question is how the assessments of safety and efficacy will be made.
AASLD was asked to share data with the FDA on biomarkers that can be used in place of liver biopsy and was asked to help advance this issue by engaging with existing public-private partnerships and potentially drafting a white paper on the topic. Regarding acceptable biomarkers, it was mentioned there is draft guidance on biomarkers for NASH. While the comment period is closed, comments can still be submitted until the guidance is final. It was agreed on hosting an interactive webinar series and session(s) prior to and at The Liver Meeting to help educate members on these topics would be useful. The group also agreed to meet regularly (i.e., every six months) to ensure the collaboration is current and on-going.