U.S. Department of Health and Human Services
​​Liver-Injury-Web-Banner_910x220.png

Liver Injury from Herbal and Dietary Supplements

5/4/2015 8:00 AM
5/5/2015 6:00 PM
Yes
No
​​For questions concerning program content, contact:

Victor J. Navarro, M.D.
Division of Hepatology
Einstein Healthcare Network
5501 Old York Road, Suite 505 Klein
Philadelphia, PA  19141
Telephone: (215) 456-8242
Fax: (215) 456-8058
Email: navarrov@einstein.edu

For questions concerning meeting logistics, contact:

John Hare, M.S., CMP, CGMP
The Scientific Consulting Group, Inc.
656 Quince Orchard Road, Suite 210
Gaithersburg, MD  20878
Phone:  (301) 670-4990
Fax:  (301) 670-3815
Email:  jhare@scgcorp.com

Bethesda
 

Event Details

A National Institutes of Health Workshop
Cosponsored by: AASLD, FDA, CDC, USDA

Aims of the Workshop: 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
   

Directions/Travel

Travel Arrangements
Travel arrangements are your own responsibility, but you should know that three airports (listed below) serve the Washington, DC, metropolitan area. Please make your own air or rail reservations.

If you decide to extend your stay to take advantage of lower fares, DC-area attractions are only a short distance away from the host hotel.

Hotel and travel information are listed below.

Hotel Reservations 
A block of sleeping rooms has been reserved at the following hotel:

Bethesda Marriott Hotel
5151 Pooks Hill Road
Bethesda, MD  20814
Phone:  (301) 897-9400 or (800) 228-9290
Fax:  (301) 897-0192

Website:  http://www.bethesdamarriott.com
(More hotel information can be obtained from this website.)

A limited number of sleeping rooms for conference participants has been reserved at the Bethesda Marriott Hotel. The rate is the prevailing government rate of $229 per night for single occupancy, plus tax (13%). To reserve a hotel room at the group rate, call reservations at (800) 266-9432 and identify yourself as a member of the NIDDK Liver Injury Meeting,or book online at http://www.marriott.com/meeting-event-hotels/niddkliver. THE ROOM BLOCK WILL BE IN EFFECT AT THE GOVERNMENT RATE ONLY UNTIL WEDNESDAY, APRIL 15, 2015, OR UNTIL FULL, WHICHEVER COMES FIRST. ANY ROOM RESERVATIONS RECEIVED AFTER THIS DATE WILL BE ACCEPTED ON A SPACE- AND RATE-AVAILABILITY BASIS. Reservations should be made for arrival on May 3, 2015, with departure on May 5, 2015. If you require alternate dates, please send an email to John Hare of The Scientific Consulting Group, Inc. (SCG) at jhare@scgcorp.com. Any alternate date requests will need to be approved through the NIDDK.

Please be certain that the hotel provides you with a confirmation number for your reservation. After
April 15, 2015, the official room block will be released, and the hotel may charge significantly higher rates and may be sold out. When making a reservation, please provide your room and bedding preferences. The hotel will assign specific room types at check-in, based on availability. Please be advised that requests are not guaranteed. Check-in time is 4:00 p.m., and checkout time is 12:00 p.m. If you need to cancel your reservation, please do so by 4:00 p.m. on the day prior to arrival, or you will be charged a
no-show fee for 1 night on your credit card.

The hotel will provide shuttle service to and from the NIH Visitor Entrance. Please check with the hotel regarding shuttle times. Be sure to have a government issued photo ID with you when you board.

Taxi Service to Area Hotels
From Baltimore/Washington International Thurgood Marshall Airport (BWI):
Approximate hotel distance and direction: 35 miles S.W.
Estimated Taxi Fare: $80

From Washington Dulles International Airport (IAD):
Approximate hotel distance and direction: 25 miles N.E.
Estimated Taxi Fare: $60

From Ronald Reagan Washington National Airport (DCA):
Approximate hotel distance and direction: 21 miles N.E.
Estimated Taxi Fare: $50

Fares may differ during peak travel hours.

Metro to the Hotel
The Metro system is clean and reliable. It operates from 5:00 a.m. to 12:00 midnight Monday through Thursday; 5:00 a.m. to 3:00 a.m. on Fridays; 7:00 a.m. to 3:00 a.m. on Saturdays; and 7:00 a.m. to 12:00 midnight on Sundays. Each passenger must purchase a farecard to travel in the system. Instructions for purchasing farecards are posted on the vending machines in each station. Each Metro car features a complete color-coded map of the system. Station attendants on duty at each station can provide additional information on request. From Ronald Reagan Washington National Airport, a cost-effective way to travel to the meeting is by using the Metrorail system. A map of the system is available at: http://www.wmata.com/rail/maps/map.cfm.

From the Ronald Reagan Washington National Airport station, take the Yellow Line toward Mt. Vernon Square or Fort Totten. At the Gallery Place/Chinatown stop, transfer to the Red Line toward Shady Grove or Grosvenor-Strathmore. For arrival at the hotel or NIH campus, exit at the Medical Center Station at the NIH. A shuttle may be arranged directly with the hotel or cabs are available.

The NIH visitor entrance is directly adjacent to the Medical Center Station. Once through security, it is a 5 minute walk to Building 38A.

SuperShuttle
SuperShuttle offers service to most hotels from Ronald Reagan Washington National Airport, Washington Dulles International Airport, and Baltimore/Washington International Thurgood Marshall Airport. The shuttle leaves on an as-needed basis between the hours of 5:30 a.m. and 11:00 p.m. During other times, arrangements for a shuttle can be made by calling 1-800-258-3826 from the airport, or visit their website at http://supershuttle.com.

NIH Visitor Information
The Lister Hill Auditorium is located on the NIH Campus in building 38A. For a map, general information, and directions to and around the NIH Campus, visit http://www.ors.od.nih.gov/maps/Pages/NIH-Visitor-Map.aspx.

NIH Security
The NIH, like all federal government facilities, has instituted security measures to ensure the safety of NIH employees, patients, and visitors. The national threat advisory level, determined by the Department of Homeland Security (http://www.whitehouse.gov/homeland/).

Perimeter Security
All visitor vehicles, including taxicabs, hotel and airport shuttles, delivery trucks, and vans will be inspected before being allowed on campus. Visitors will be asked to show one (1) form of identification (a government-issued photo ID: driver's license, passport, green card, etc.) and to state the purpose of their visit. Be sure to allow at least 15-20 minutes for this vehicle inspection procedure.

Building Security
Due to the checking of IDs at the perimeter, employees and visitors will not be required to show their ID again to gain access to the majority of buildings on the NIH Campus during the normal business day.

Employees and visitors should continue to wear their identification prominently at all times while on campus.

Guards will remain at certain buildings to address specific program requirements, such as sensitive research and safety concerns. At building entrances where guards are posted:

  • Employees must show a DHHS-issued photo ID (for example, your NIH-issued ID badge).
  • Visitors may be required to log-in, wear a visitor's pass, and be escorted by an employee through the building.
  • Visitors may be required to pass through a metal detector and have bags, backpacks, or purses inspected or x-rayed as they enter buildings.
  • Security staff will confiscate any suspicious or potentially dangerous materials. U.S. code prohibits bringing any dangerous weapons onto federal property, including anything with a blade longer than

2½ inches. Meeting participants may want to leave extra bags or personal materials at their hotel to minimize the time needed for inspection.

Weekday Pedestrian Campus Access
All visitors must enter through the NIH Gateway Center at Metro or the West Gateway Center (see the Gateway Map at http://www.ors.od.nih.gov/maps/Pages/Gateway-Center-Map.aspx).

  • Gateway Center

Wisconsin Avenue at Gateway Drive (near the Metro)
Open 24 hours, 7 days per week

  • West Gateway Center

Near Old Georgetown Road and South Drive
Open 6:00 a.m. – 12:00 p.m., Monday-Friday

Driving Directions to NIH
From Points North and East:
Take I-95 South to I-495 West (Capital Beltway) toward Silver Spring. Follow I-495 West for 9 miles to Exit 34 (Bethesda/Wisconsin Avenue). Follow signs for Route 355 South and stay in the right lane. Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 38A.

From Points North and West:
Take I-270 South to I-495 East (Capital Beltway) toward Washington, DC. Stay in one of the three left lanes. Follow signs for Route 355 South, a left-lane exit, onto Wisconsin Avenue. Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 38A.

From Points South:
Take I-95 North to I-495 (Capital Beltway) toward Tyson's Corner/Rockville. Follow I-495 for 20 miles. Take Exit 34 (Bethesda/Wisconsin Avenue). Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 38A.

From Baltimore/Washington International Thurgood Marshall Airport (BWI):
Take the Route 195 connector to I-95 South. Take I-95 South to I-495 West (Capital Beltway) toward Silver Spring. Follow I-495 West for 9 miles to Exit 34 (Bethesda/Wisconsin Avenue). Follow signs for Route 355 South and stay in the right lane. Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 38A.

From Washington Dulles International Airport (IAD):
Take the Dulles Access Road for approximately 13 miles to Exit 18. Move to the right on the Dulles Toll Road (Route 267) and take Exit 18. Stay left on the ramp for Bethesda/Baltimore, and proceed toward Bethesda (I-495). Continue approximately 9 miles on I-495. Stay on I-495 at the I-495/I-270 split (bear right). Take Exit 34 (Wisconsin Avenue South/Route 355) toward Bethesda. Travel approximately
1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to
Building 38A.

From Ronald Reagan Washington National Airport (DCA):
Take the George Washington Parkway North for 12 miles to I-495 toward Maryland (Capital Beltway). Take Exit 34 (Bethesda/Wisconsin Avenue). Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 38A.

 

 

Parking
Parking on the NIH campus is limited and is $12 per day in the visitor lots.​

Minutes

 Meeting minutes are not available at this time.

Attendees

Attendee information is not available at this time.

Abstracts

Call for Abstracts


Submission Deadline: Friday, April 10, 2015

Participants in the Liver Injury from Herbal and Dietary Supplements, are encouraged to submit abstracts of their research activities. Abstracts can include original research, case reports, or case series descriptions. In addition to an opportunity to present their research in a poster session, conference attendees will find additional career development and networking opportunities with other researchers.

All abstracts must be submitted via uploading to the conference website. Abstract submissions should be no longer than 250 words (not including name and affiliation).

Please follow the instructions below to submit an abstract for consideration:

  1. The abstract should be an MS Word document typed single-spaced using 10 point type. The abstract's title should be typed in CAPITAL LETTERS and should clearly represent the nature of the investigation. The title should be followed in lowercase letters by the author's first and last names, degree, and affiliation (if applicable), city, state, and country. Underline the primary author's name (one primary author per abstract). Do not leave spaces between the title and the body of the abstract, or between paragraphs. The abstract file should be saved as: primary authors' last name_first word in the title (e.g., Zucker_Effects).
  2. Please ensure that your abstract is the correct length and use 1" margins.
  3. Use of standard abbreviations is desirable (e.g., RBC) as well as standard symbols for units of measure (e.g., kg, gm, mg, mL, L, and %). Place a special or unusual abbreviation in parentheses after the full word the first time that it appears. Use numerals to indicate numbers except to begin sentences. Do not use subtitles (e.g., Methods, Results).
  4. Simple tables or graphs may be included; however, they must fit within the designated abstract space of one page.
  5. Please use Times New Roman as the font.

 

Body of the Abstract

  1. Organize the body of the abstract as follows:
    • Statement of the purpose of the study/program/project;
    • Statement of the methods used;
    • Summary of the results presented in sufficient detail to support the conclusion; and
    • Statement of the conclusions reached.

POSTER PRESENTATIONS

Poster presentations will be displayed on 4-foot-high by 6-foot-wide poster boards. Pushpins and Velcro will be provided onsite.

All presenters must pre-register for the conference.

Location

Line
  • Lister Hill Auditorium, Building 38A
  • NIH Campus
  • MD
Webinar

Contacts

Line ​​For questions concerning program content, contact:

Victor J. Navarro, M.D.
Division of Hepatology
Einstein Healthcare Network
5501 Old York Road, Suite 505 Klein
Philadelphia, PA  19141
Telephone: (215) 456-8242
Fax: (215) 456-8058
Email: navarrov@einstein.edu

For questions concerning meeting logistics, contact:

John Hare, M.S., CMP, CGMP
The Scientific Consulting Group, Inc.
656 Quince Orchard Road, Suite 210
Gaithersburg, MD  20878
Phone:  (301) 670-4990
Fax:  (301) 670-3815
Email:  jhare@scgcorp.com