Public Access Records Office
The National Academies
500 5th Street NW
Room KECK 219
Washington, DC 20001
Tel: (202) 334-3543
Email: paro@nas.edu
Project Information

Project Information


Long-Term Health Effects of Antimalarial Drugs


Project Scope:

An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will conduct a study to assess the long-term health effects that might result from the use of antimalarial drugs by adults, in particular mefloquine, for the prophylaxis of malaria. The committee will examine the currently available medications, as approved by Food and Drug Administration and/or used by the Department of Defense, and of interest to the Department of Veterans Affairs, and the long-term health effects that might occur in any organ system. These include latent effects that might be expected from their use by Service members during deployment to areas with endemic malaria, such as Afghanistan. Special attention will be given to possible long-term neurologic effects, long-term psychiatric effects and the potential development of Posttraumatic Stress Disorder (PTSD). Additionally, the committee will consider approaches for identifying short-term, long-term, and persistent adverse health effects of antimalarials. The committee will develop findings and conclusions based on its review of the evidence; the report will not include recommendations.


Status: Current

PIN: HMD-BPH-18-07

Project Duration (months): 18 month(s)

RSO: Styka, Anne

Topic(s):

Health and Medicine



Geographic Focus:

Committee Membership

Committee Post Date: 01/04/2019

David A. Savitz - (Chair)
David A. Savitz, Ph.D., is a professor of epidemiology in the Brown University School of Public Health where he serves as associate dean for research and holds joint appointments as a professor of obstetrics and gynecology and pediatrics in the Alpert Medical School. From 2013-2017, Dr. Savitz served as the vice president for research at Brown University. He came to Brown in 2010 from Mount Sinai School of Medicine, where he had served as the Charles W. Bluhdorn Professor of Community and Preventive Medicine and the director of the Disease Prevention and Public Health Institute since 2006. Before that appointment, he taught and conducted research at the University of North Carolina School of Public Health and at the Department of Preventive Medicine and Biometrics at the University of Colorado School of Medicine. Dr. Savitz received his undergraduate training in psychology at Brandeis University, holds a master’s degree in preventive medicine from The Ohio State University, and received his Ph.D. in epidemiology from the University of Pittsburgh Graduate School of Public Health. His epidemiological research has addressed a wide range of public health issues including exposures related to military deployments, veterans’ health, environmental effects of energy development, childhood obesity, pesticides and breast cancer, risks from environmental exposures during pregnancy, and drinking water safety. Dr. Savitz has directed 31 doctoral dissertations and 15 master’s theses. He is the author of nearly 350 papers in professional journals and the editor or author of three books on environmental epidemiology. He has served as editor at the American Journal of Epidemiology and Epidemiology, and as a member of the Epidemiology and Disease Control-1 study section of the National Institutes of Health. He has served as president of the Society for Epidemiologic Research, the Society for Pediatric and Perinatal Epidemiologic Research, and the North American Regional Councilor for the International Epidemiological Association. Dr. Savitz is a member of the National Academy of Medicine, and has previously served on 11 consensus committees, five of which he chaired or was the vice-chair, in addition to serving on several other NASEM convening activities.
Sara Dolan
Sara Dolan, Ph.D., is an associate professor of psychology and neuroscience and the graduate program director at Baylor University. She completed her Ph.D. in Clinical Psychology at the University of Iowa and completed her clinical internship in the Division of Substance Abuse at Yale University. Her early research primarily focused on substance abuse, but more recently her work has focused on the diagnosis and treatment of the comorbidity between posttraumatic stress disorder (PTSD) and traumatic brain injury (TBI). The goal of her research is to determine distinguishing factors between PTSD and TBI to improve diagnosis and treatment of each to improve overall functioning and well-being. Dr. Dolan has authored or co-authored more than 35 peer-reviewed journal articles.
Marie R. Griffin
Marie Griffin, M.D., M.P.H., is a professor of Health Policy and Medicine and directs the Master of Public Health program at Vanderbilt University. She received her M.D. from Georgetown University and her master’s in public health from Johns Hopkins Bloomberg School of Public Health. Dr. Griffin completed her medical residency at Emory University and then served as an epidemic intelligence service officer through the Centers for Disease Control and Prevention, and was a clinical epidemiology fellow at Johns Hopkins. She is a general internist and pharmocoepidemiologist whose research focuses on safety and effectiveness of drugs and vaccines, program evaluation, and methods in pharmocoepidemiology. She has served on Food and Drug Administration committees, including the Nonprescription Drugs Advisory Committee and the Vaccine and Related Products Advisory Committee, and continues to serve as a member of the Drug Safety and Risk Management Advisory Committee. She also serves as a work group member of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices for respiratory syncytial virus vaccine. She has worked extensively with administrative data from the Tennessee Medicaid program and the Department of Veterans Affairs to analyze data on comparative effectiveness and safety of drugs and vaccines. Her work has consistently provided scientific evidence that has been used to drive policy. Dr. Griffin has authored or co-authored more than 350 peer-reviewed journal articles. She has previously served as a member of the National Academies’ Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines.
James P. Herman
James Herman, Ph.D., is the Flor van Naanen professor, chair of the Department of Pharmacology & Systems Physiology, and the director of the Neurobiology Research Center and the Stress Neurobiology Laboratory at the University of Cincinnati. Dr. Herman’s research examines the relationship between the physiological actions of central nervous system stress circuits and their place in the central nervous system. His work primarily focuses on two areas. The first area is limbic system regulation of the stress response and, consequently, on the generation of stress-related disorders, ranging from major depressive illness to PTSD to essential hypertension, to neurodegeneration and aging. The second focus of his research is on defining the role of central adrenocorticosteroid receptors in transducing stress-related signals in normal physiology, aging, and disease states. Dr. Herman completed his Ph.D. at the University of Rochester, and his post-doctoral training at the Mental Health Research Institute at the University of Michigan. He has received several awards for his research and he has authored or co-authored more than 340 peer-reviewed journal articles.
Yuval Neria
Yuval Neria, Ph.D., is a professor of medical psychology in the Department of Psychiatry and Epidemiology at Columbia University Medical Center and the director of the PTSD Research Program at the New York State Psychiatric Institute. Dr. Neria completed his doctoral studies at the Haifa University in Israel, and has led and collaborated on numerous epidemiological, clinical, and neuroimaging studies of trauma and posttraumatic stress disorder (PTSD). His research focusses on translational research aiming to identify behavioral and neural markers for trauma related psychopathology. Dr. Neria uses multimodal brain imaging and a number of novel paradigms focusing on fear circuitry to probe new biomarkers of PTSD, and to identify structural and functional neural markers of clinical response to PTSD treatment. He is primarily interested in clarifying the clinical, behavioral, and neural signatures of trauma and PTSD. He is the recipient of the Medal of Valor for his military service in Israel. Dr. Neria is the author of more than 180 peer-reviewed articles and book chapters, a war novel, and co-edited four textbooks focusing on the mental health consequences of exposure to trauma.
Andy S. Stergachis
Andy Stergachis, Ph.D., M.S., directs the Global Medicines Program in the Department of Global Health at the University of Washington (UW). He is professor of Pharmacy and Global Health and an associate dean in the School of Pharmacy. His research focuses on pharmacoepidemiology, global drug and vaccine safety, and pharmaceutical outcomes research. He is author of 158 peer-reviewed publications in areas such as pharmacovigilance, pharmacoepidemiology, pharmaceutical outcomes, and clinical epidemiology and serves as Editor-in-Chief of the Journal of the American Pharmacists Association. He presently serves as a co-investigator with the UW Institute for Health Metrics and Evaluation for a study on Mapping and Monitoring the Global Burden of Antimicrobial Resistance. He recently directed a study on the safety of antimalarial drugs used during pregnancy conducted in three sub-Saharan African (SSA) countries and has developed novel approaches for malaria and HIV pharmacovigilance and strengthening pharmacy services in SSA. Through his affiliation with the Northwest Center for Public Health Practice, he works on workforce development and public health systems research in emergency preparedness with the public health community. He is also affiliated with the UW Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute. He is Chair of the Expert Panel to Review Surveillance and Screening Technologies for the Quality Assurance of Medicines for USP, Chair of the Low-dose Primaquine Safety Study Group for the WorldWide Antimalarial Resistance Network, and has served as member of the Access and Product Management Advisory Committee for Medicines for Malaria Venture. He is a Fellow of the International Society for Pharmacoepidemiology and Fellow of the American Pharmacists Association-Academy of Pharmaceutical Research and Science. Dr. Stergachis is a member of the National Academy of Medicine (elected 2012). He has served on numerous National Academies’ committees, including the Committee on Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces and the Committee on the Assessment of the U.S. Drug Safety System. Dr. Stergachis received his bachelors of pharmacy from Washington State University and both his master’s degree in pharmacy administration and his doctorate in social an administrative pharmacy from the University of Minnesota.
Elizabeth A. Stuart
Elizabeth Stuart, Ph.D., is a professor in the Department of Mental Health in the Johns Hopkins Bloomberg School of Public Health with joint appointments in the Departments of Biostatistics and Health Policy and Management, and she is also the associate dean for education at JHSPH. Dr. Stuart has an undergraduate degree in mathematics from Smith College and completed her Ph.D. in statistics at Harvard University. Her research has addressed several areas in public health including mental health services, health care policy evaluation, and long-term effects of substance abuse. Her research focuses on the use of different design and analysis methods for estimating causal effects, especially in terms of improving the internal validity of non-experimental studies and the external validity of randomized studies. She also researches methods for addressing missing data and non-compliance, and has made important contributions to collaborative and methodological research in the area of causal inference applied to mental health and psychology. Dr. Stuart is also affiliated with several other Johns Hopkins centers including Drug Safety and Effectiveness, Mental Health and Addiction Policy Research, and the Bloomberg American Health Initiative. She is an Elected Fellow of the American Statistical Association, for which she was a founding member of the Mental Health Statistics Section and has received the Gertrude Cox Award for applied statistics and the Myrto Lefkopoulou award from the Harvard University Department of Biostatistics. She is an associate editor and reviewer for several journals related to statistics, epidemiologic methods, and mental health, and she has contributed to nearly 200 peer-reviewed publications. She has consistently been recognized for her outstanding abilities in teaching, and has received several awards for her teaching and research. Dr. Stuart has previously served as a panel member for the National Academies on an activity related to methodologies for studying commercial motor vehicle driver fatigue.
Carol A. Tamminga
Carol Tamminga, M.D., is a professor, chairman of Psychiatry and chief of Translational Neuroscience Research in Schizophrenia at the University of Texas Southwestern Medical School. She holds the Communities Foundation of Texas Chair in Brain Science along with the Lou and Ellen McGinley Distinguished Chair in Psychiatric Research. She directs clinical and preclinical research in schizophrenia focused on identifying disease mechanisms and on improving treatments. Dr. Tamminga graduated from Vanderbilt Medical School and completed a psychiatry residency at the University of Chicago and spent many years at the University of Maryland, MPRC, then moved to UT Southwestern Medical School to continue her research. Dr. Tamminga has been the recipient of numerous federal and foundation grants, as well as awards in the field. She has served on the National Advisory Mental Health Council, NIMH and the Council of the National Institute of Drug Abuse. Dr. Tamminga was elected to the National Academy of Medicine in 1998 and has served on several IOM committees in that capacity. The goal of Dr. Tamminga’s research is to examine and understand the mechanisms underlying schizophrenia, especially its most prominent symptoms, psychosis and memory dysfunction, in order to build rational treatments for the illness. She evaluates the function of the living human brain in individuals with and without schizophrenia using brain imaging techniques. Then, building on this knowledge, she uses human postmortem brain tissue to translate the functional alterations from the living human patient into molecular observations of the illness. Now she is using case-specific neuronal cultures to address molecular and cellular questions. Her ultimate goal is to use the alterations in in vivo imaging, postmortem molecular changes and cultured neuronal characteristics as biomarkers and targets for identifying animal models of disease and novel active pharmaceuticals for psychosis.
Jonathan Vennerstrom
Jonathan L. Vennerstrom, Ph.D., is a professor in the Department of Pharmaceutical Sciences in the College of Pharmacy at the University of Nebraska Medical Center. He received his Ph.D. in medicinal chemistry from the University of Minnesota, and completed his post-doctoral training at Walter Reed. Dr. Vennerstrom’s work focuses on anti-infective drug discovery, particularly the medicinal chemistry of antiparasitic agents and the investigation of heme as a mechanistic intersection for antimalarial drugs. His work has led to the discovery of new mechanisms of action of chloroquine (and other antimalarial quinolines) and new understanding of mechanisms of how hemozoin is formed in the malaria parasite. His research has comprehensively characterized the structural features of chloroquine associated with its antimalarial properties, and shown that peroxide antimalarial activity depends upon parasite hemoglobin digestion. Two antimalarial drug candidates were discovered during his work with the Medicines for Malaria Venture; one is now available in India and the other is in Phase IIb trials as a potential single-dose malaria treatment; both of these drugs are outside of the committee’s statement of task. Dr. Vennerstrom continues to use the knowledge generated by his research in order to discover other antimicrobial drug candidates for several infectious diseases, including malaria. He is a member of the American Society for Microbiology, the American Society of Tropical Medicine and Hygiene, and the American Chemical Society from which he received the ACS Award for Creative Innovation in 2019. He has received several other awards including the two-time recipient of the Medicines for Malaria Venture Project of the Year Award (2001, 2006), Alvin M. Earle Outstanding Health Science Educator Award, University of Nebraska Medical Center Distinguished Scientist Award, UNeMed Lifetime Achievement Award, and the University of Nebraska Innovation, Development, and Engagement (IDEA) Award. His work continues to drive innovation in the drug discovery field. Dr. Vennerstrom has authored or co-authored more than 150 peer-reviewed journal articles.
Christina M. Wolfson
Christina M. Wolfson, Ph.D., is a professor in the Department of Medicine and the Department of Epidemiology, Biostatistics and Occupational Health, at McGill University and senior scientist in the Brain Repair and Integrative Neuroscience (BRAIN) Program at the Research Institute of the McGill University Health Centre. She is an associate member in the Departments of Neurology and Neurosurgery, and Mathematics and Statistics at McGill University. A neuroepidemiologist, her program of research lies in population-based research in neurodegenerative disorders including multiple sclerosis, Parkinson’s disease, and epilepsy. She is co-Principal investigator on the Canadian Longitudinal Study on Aging, a 20-year study of 50,338 participants aged 45-85 in which she leads the Neurological Conditions Initiative and the Veterans’ Health Initiative and is the Director of the CLSA Statistical Analysis Centre. Dr. Wolfson is co-principal investigator on a 5-country MS risk factor study (Environmental Risk Factors in Multiple Sclerosis - EnvIMS) completed in Italy, Norway, Serbia, Sweden and Canada. She is also the Program Director of the endMS National Training Program.
Dr. Wolfson received her undergraduate degree in mathematics, her master’s degree in mathematical statistics, and her Ph.D. in epidemiology and biostatistics from McGill University. She has published over 220 peer-reviewed journal articles and has previously served as a member on four National Academies’ consensus committees related to health effects in U.S. veterans that served in the 1990-1991 Gulf War and Post 9/11 conflicts.

Events



Location:


Hyatt Centric Chicago Magnificent Mile
Chicago, IL, USA

Event Type :  
Meeting

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Rebecca Chevat
Contact Email:  Antimalarials@nas.edu
Contact Phone:  (202) 334-3275

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Publication(s) resulting from the event:

-


Location:

J. Erik Jonsson Woods Hole Center
314 Quissett Ave.
Woods Hole, Massachusetts
Event Type :  
Meeting

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Rebecca Chevat
Contact Email:  Antimalarials@nas.edu
Contact Phone:  (202) 334-3275

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

David Savitz
Sara Dolan
Marie R. Griffin
James P. Herman
Yuval Neria
Andy Stergachis
Elizabeth A. Stuart (via remote connection Day 2)
Carol Tamminga
Jonathan Vennerstrom
Christina Wolfson

The following topics were discussed in the closed sessions:

• Discussed draft text of the chapters on the antimalarial drugs of interest, which included reviewing the identified literature for each drug, and discussing the quality of the evidence and its weight in contributing toward making conclusions on the association between drug use and long-term health outcomes.

• Determined a work plan for reviewing, summarizing, assessing, and presenting the remaining primary epidemiologic literature identified, for reviewing and incorporating all remaining evidence, and for synthesizing information and shaping conclusions.

• Reviewed all draft text of the report to identify areas that require revision or elaboration.

• Outlined the findings from the evidence base and methodologic approaches for identifying short-term, long-term, and persistent adverse health effects of antimalarials.

• Led by a National Academies communications staff person, considered and discussed how to ensure report findings and conclusions are framed and communicated to optimize their usefulness to varied populations (e.g., veterans, users of malaria prophylaxis, clinicians, research community).

The following materials (written documents) were made available to the committee in the closed sessions:

• Agenda book
• Journal articles and related literature
• Presentation slides from communications staff speaker

Date of posting of Closed Session Summary:
August 06, 2019
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
Meeting

Description :   

The National Academies of Sciences, Engineering, and Medicine Committee to Review Long-Term Effects of Antimalarial Drugs will be having a public session as part of its information gathering activities. The public session will be held on Wednesday, March 27, 2019, from 9:30 AM to 11:30 AM ET, at the National Academies' Keck Building (500 Fifth Street, NW) in Washington, DC.

This session will feature invited presentations from agencies and topical experts including:

  • Policies regarding the use of antimalarials in the Peace Corps and the Department of State.
  • Neurotoxic mechanisms of antimalarial drugs, in particular mefloquine.

The session will be accessible to the public via a dial-in connection with a web-based platform that will enable projected material to be seen, and in-person attendance (seating is limited). Please register online to attend either in-person or remotely. There will be an additional form attached to the Eventbrite page to fill if attending remotely. 





If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Rebecca Chevat
Contact Email:  Antimalarials@nas.edu
Contact Phone:  (202) 334-3275

Supporting File(s)
-
Is it a Closed Session Event?
Some sessions are open and some sessions are closed

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

David Savitz
Sara Dolan
Marie R. Griffin
James P. Herman (via remote connection)
Yuval Neria
Elizabeth A. Stuart
Carol Tamminga
Jonathan Vennerstrom
Christina Wolfson

The following topics were discussed in the closed sessions:

• Refining the parameters of the literature to be reviewed
• Determining a work plan for reviewing the literature and synthesizing it
• Focused reviews of topics that are relevant to addressing the Statement of Task
• Review of preliminary draft report text
• The need for further requests for information from federal agencies

The following materials (written documents) were made available to the committee in the closed sessions:

• Agenda book
• Journal articles and related literature
• Presentation slides from speakers

Date of posting of Closed Session Summary:
March 29, 2019
Publication(s) resulting from the event:

-


Location:

National Academy of Sciences Building
2101 Constitution Ave NW, Washington, DC 20418
Event Type :  
Meeting

Description :   

The National Academies of Sciences, Engineering, and Medicine Committee to Review Long-Term Effects of Antimalarial Drugs will be having a public session as part of its information gathering activities. The public session will be held on Monday, January 28, 2019, from 1:00 PM to 5:00 PM ET, at the National Academy of Sciences Building in Washington, DC.

This session will feature invited presentations from several agencies and topical experts including:

  • The official charge to the committee from the study sponsor, Department of Veterans Affairs.
  • Policies regarding the use of antimalarials in the Department of Defense.
  • Overview of data collection and monitoring of adverse effects by the Food and Drug Administration and Centers for Disease Control and Prevention.

The session will be accessible to the public via live webcast and in-person attendance (seating is limited). Please register for the public session online for attending both in-person or via live webcast. There will be an additional form attached to the Eventbrite page to fill if attending by webcast. 

More information about this session (e.g., agenda and speakers) will be forthcoming.
More information about the study can be found here





If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Rebecca Chevat
Contact Email:  Antimalarials@nas.edu
Contact Phone:  (202) 334-3275

Supporting File(s)
-
Is it a Closed Session Event?
Some sessions are open and some sessions are closed

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

David Savitz
Sara Dolan
Marie R. Griffin
James P. Herman
Yuval Neria
Andy S. Stergachis
Elizabeth A. Stuart
Carol Tamminga (Day 1 only)
Jonathan Vennerstrom
Christina Wolfson

The following topics were discussed in the closed sessions:

• Standard bias or conflict of interest discussion according to NRC procedures
• Overview of the committee process and related administrative issues
• Discussion of the Statement of Task and consideration of approaches to addressing it
• Development of a work plan and draft report outline

The following materials (written documents) were made available to the committee in the closed sessions:

• Agenda book
• Journal articles and related literature
• Presentation slides from speakers

Date of posting of Closed Session Summary:
February 04, 2019
Publication(s) resulting from the event:

-

Publications

  • Publications having no URL can be seen at the Public Access Records Office
Publications

No data present.