Event Details
Agenda
Event Details
Background
A National Institutes of Health Workshop cosponsored by: AASLD, FDA, CDC, USDA
Meeting Objectives
To evaluate the current status of use of herbal and dietary supplements (HDS) and the problem of their occasional hepatotoxicity. HDS are used commonly by the U.S. population and instances of acute liver injury in persons taking the products, although rare, are being increasingly reported. A similar rise in the frequency of reports of HDS-associated liver injury comes from Iceland, Europe, and Asia. The liver injury from HDS presents many clinical and research challenges. It is invariably unexpected and unpredictable, typically presenting in an acute viral hepatitis-like pattern, but without any serological markers of known hepatitis virus infections and with no evidence of other possible etiologies. The liver injury can be severe and lead to death from acute liver failure or the need for emergency liver transplantation. The attribution of the injury to a specific product is often difficult. Patients presenting with the acute liver injury often do not mention that they are taking HDS, or they may not know when they started or stopped the product, the dose, and sometimes even the name or nature of the HDS. The products themselves are often poorly labeled or mislabeled for their constituents and may have many components with little information on their concentration, source, or documentation of purity. This workshop is meant to bring together various federal, academic, and industry experts on HDS, biochemical analysis, hepatology, epidemiology, and surveillance of adverse events. The major aims of the symposium are to set a research agenda for better elucidation of the frequency, epidemiology, clinical features, outcomes, consequences, mechanisms, and means of treatment or prevention of liver injury associated with HDS. A summary of the workshop will be prepared for publication.
Agenda
May 4, 2015
- 7:30 a.m.
- Registration
- 8:20 a.m.
- Welcome and Aims
Jay Hoofnagle, M.D., Liver Disease Research Branch (LDRB), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
Session I: Herbal and Dietary Supplement (HDS) Use in the United States
Moderators: Jay Hoofnagle, M.D. LDRB, NIDDK, NIH; and Paul Watkins, M.D., University of North Carolina, School of Medicine
- 8:30 a.m.
- Scope of Herbal and Dietary Supplements
Paul Coates, Ph.D., Director, Office of Dietary Supplements, Office of the Director, NIH
- 8:50 a.m.
- Current Use of Herbal Products in the United States
D. Craig Hopp, Ph.D., Program Director, National Center for Complementary and Integrative Health,
NIH
- 9:10 a.m.
- Regulation of HDS in the United States
Cara Welch, Ph.D., Acting Director, Division of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration (FDA)
- 9:30 a.m.
- Current Market for HDS in the United States
Mark Blumenthal, Founder and Executive Director, American Botanical Council, Editor,
HerbalGram and HerbClip
- 9:50 a.m.
- Discussion
- 10:15 a.m.
- Break
Session 2: HDS-associated Liver Injury in the United States
Moderators: Averell Sherker, M.D., FRCP (C), LDRB, NIDDK, NIH; and Robert Fontana, M.D., Department of Medicine, University of Michigan, School of Medicine
- 10:40 a.m.
- Rising Burden of HDS-associated Liver Injury
Victor Navarro, M.D., Chairman, Division of Hepatology, Einstein Healthcare Network
- 11:00 a.m.
- Histologic Features of HDS Liver Injury
David Kleiner, M.D., Ph.D., Laboratory of Pathology, National Cancer Institute, NIH
- 11:20 a.m.
- Anabolic Steroid-associated Liver Injury
Andrew Stolz, M.D., Associate Professor of Medicine, Chief Gastrointestinal Service LAC+USC General Hospital
- 11:40 a.m.
- Challenges in Assigning Causality
Leonard Seeff, M.D., Consultant in Hepatology, Einstein Healthcare Network
- 12:00 p.m.
- Discussion
- 12:30 p.m.
- Lunch and Poster Viewing
Session 3: HDS-associated Liver Injury Worldwide
Moderators: Jose Serrano, M.D., Ph.D., LDRB, NIDDK, NIH; and John Senior, M.D., Office of Drug Safety, FDA
- 1:20 p.m.
- Iceland
Einar Björnsson, M.D., Ph.D., The National University Hospital of Iceland
- 1:40 p.m.
- Europe and Latin America
M. Isabel Lucena, M.D., Ph.D., Professor of Pharmacology, Clinical Pharmacology Service, Biomedical Research Institute of Málaga, Hospital Universitario Virgen de la Victoria, Malaga University, Spain
- 2:00 p.m.
- India
Harshad Devarbhavi, M.D., D.M., Head, Department of Gastroenterology and Hepatology, St. John's Medical College Hospital, Bangalore
- 2:20 p.m.
- China
Chenghai Liu, M.D., Ph.D., Institute of Liver Diseases, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
- 2:40 p.m.
- Discussion
- 3:00 p.m.
- Break
Session 4: Specific Paradigms of HDS-associated Liver Injury
Moderators: Leonard Seeff, M.D. Einstein Healthcare Network; and Naga Chalasani, M.D., Indiana University School of Medicine
- 3:20 p.m.
- Known Botanical Hepatotoxins
Joseph Betz, Ph.D., Director, Analytical Methods and Reference Materials Program, Office of Dietary Supplements, NIH
- 3:40 p.m.
- Green Tea Hepatotoxicity
Herbert Bonkovsky, M.D., Professor of Medicine and Molecular Medicine and Translational Science, Chief of Hepatology, Wake Forest University School of Medicine
- 4:00 p.m.
- Black Cohosh and Green Tea Extract: Assessment of Liver Injury Reports
Nandu Sarma, R.Ph., Ph.D., Director, Dietary Supplements, United States Pharmacopeia
- 4:20 p.m.
- OxyElite Pro: The Epidemic
Ethel V. Taylor, D.V.M., M.P.H., Health Studies Branch, National Center for Environmental Health, Centers for Disease Control and Prevention
- 4:40 p.m.
- Discussion
- 5:00 p.m.
- Adjourn for the Day
May 5, 2015
- 8:15 a.m.
- Welcome and Comments
Victor Navarro, M.D., Chairman, Division of Hepatology, Einstein Healthcare Network
Session 5: Chemical Evaluation of HDS
Moderators: Herbert Bonkovsky, M.D., Professor of Medicine and Molecular Medicine and Translational Science, Chief of Hepatology, Wake Forest University School of Medicine; and Don Rockey, M.D., Medical University of South Carolina
- 8:30 a.m.
- Chemical Approaches to HDS Authentication
James Harnly, Research Leader, Food Composition and Methods Development Lab, Beltsville Human Nutrition Research Center, Agricultural Research Service, U.S. Department of Agriculture
- 8:50 a.m.
- Chemical Characterization of HDS
Ikhlas Khan, Ph.D., D. Litt. (Hon. Causa), Assistant Director, National Center for Natural Products Research (NCNPR), Director, FDA Center of Excellence, Research Professor, Department of Pharmacognosy, School of Pharmacy, University of Mississippi
- 9:10 a.m.
- Drug Adulteration of HDS
Jamie Dunn, Ph.D., Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, FDA
- 9:30 a.m.
- Analysis of Botanical Mixtures
Cynthia Rider, Ph.D., DABT, National Toxicology Program, National Institute of Environmental Health Sciences (NIEHS), NIH
- 9:50 a.m.
- Discussion
- 10:20 a.m.
- Break
Session 6: Liver Injury Associated with HDS: Creating an Agenda for the Future
Moderators: Victor Navarro, M.D. Einstein Healthcare Network; and Mark Avigan, M.D., Office of Surveillance and Epidemiology, FDA
- 10:40 a.m.
- Linking Ingredients to Liver Injury: Toxicological Strategies
Stephen Ferguson, National Toxicology Program, NIEHS, NIH
- 11:00 a.m.
- Botanicals and Liver Injury: Getting from Phytochemistry to Toxicology
Larry Walker, Ph.D., Director, NCNPR, Professor of Pharmacology, School of Pharmacy, Associate Director for Basic Sciences, University of Mississippi Cancer Institute
- 11:20 a.m.
- Current Regulations: Are They Sufficient?
Pieter Cohen, M.D., Cambridge Health Alliance, Harvard Medical School
- 11:40 a.m.
- Overseeing FDA's Regulation of Dietary Supplements
Lisa Van Arsdale, Senior Analyst, Department of Natural Resources and Environment, U.S. Government Accountability Office
- 12:00 p.m.
- Experimental Approaches to HDS-associated Hepatotoxicity
Neil Kaplowitz, M.D., Division of Gastroenterology and Liver, University of Southern California Keck School of Medicine
- 12:20 p.m.
- Future Directions and Discussion
Jay Hoofnagle, M.D.
- 12:50 p.m.
- Adjournment
