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Project Information

Project Information


Development of a Protocol to Evaluate the Concomitant Prescribing of Opioid and Benzodiazepine Medications and Veterans Deaths and Suicides


Project Scope:

An ad hoc committee, under the auspices of the National Academies of Sciences, Engineering, and Medicine, will develop a protocol (study design), to evaluate the relationship between concomitant opioid and benzodiazepine medication practices at the Department of Veterans Affairs (VA), for treating mental health and combat-related trauma, which potentially led to veteran’s deaths and suicides. The VA has not requested specific recommendations.

Status: Current

PIN: HMD-HCS-18-08

Project Duration (months): 12 month(s)

RSO: Fulco, Carolyn

Board(s)/Committee(s):

Board on Health Care Services

Topic(s):

Health and Medicine



Geographic Focus:

Committee Membership

Committee Post Date: 01/09/2019

Brian L. Strom - (Chair)
Brian L. Strom is the Inaugural Chancellor of Rutgers Biomedical and Health Sciences (RBHS) and the Executive Vice President for Health Affairs at Rutgers University. RBHS is comprised of eight schools and seven centers/institutes, and includes academic, patient care, and research facilities. These are most of the units of the former University of Medicine and Dentistry of New Jersey (UMDNJ), now dissolved, several Rutgers University units with health-related missions, and two research units historically co-managed by Rutgers and UMDNJ. The integration of these entities is designed to create a single organization that will lead to new models for clinical care and community service, educate the next generation of health care providers utilizing health care team approaches, and conduct research. Dr. Strom was formerly the Executive Vice Dean of Institutional Affairs, Founding Chair of the Department of Biostatistics and Epidemiology, Founding Director of the Center for Clinical Epidemiology and Biostatistics, and Founding Director of the Graduate Program in Epidemiology and Biostatistics, all at the Perelman School of Medicine of the University of Pennsylvania (Penn).

Dr. Strom is a nationally recognized leader in clinical research training. He was previously elected President of the Association of Clinical Research Training and was principal investigator (PI) or co-PI for eight National Institutes of Health (NIH)-funded clinical research training programs. More than 560 clinicians have been trained or are in training through the CCEB’s Master of Science in Clinical Epidemiology degree program, which Dr. Strom helped develop in the late 1970s and early 1980s and which he led for many years. All but about 55 MSCE trainees have appointments in academic or other research institutions. Dr. Strom received the 2004 Christian R. and Mary F. Lindback Award, Penn’s most prestigious teaching award, in recognition of the contribution he has made in his career to clinical research training.

Dr. Strom was a member of the Board of Regents of the American College of Physicians (ACP), and the Boards of Directors of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), the American College of Epidemiology, and the Association for Patient-Oriented Research. He was previously President of ISPE. Dr. Strom was on the Drug Utilization Review Committee and the Gerontology Committee of the USP and the representative from the ACP to the USP. He served on the Drug Safety and Risk Management Advisory Committee for the FDA. Dr. Strom was Chair of the Institute of Medicine’s (IOM) Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Chair of the IOM Committee on Smallpox Vaccine Program Implementation, and was a member of the IOM Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program. He chaired the IOM Committee to Review the National Institute for Occupational Safety and Health’s Traumatic Injury Program, Consequences of Sodium Reduction in Populations, and Committee on a National Strategy for the Elimination of Hepatitis B and C, and was a member of the IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. He served on the National Research Council Report Review Committee.

In 2001, Dr. Strom was elected as a member of the National Academy of Medicine. He most recently served on the Forum on Drug Discovery, Development and Translation. Dr. Strom has served on over ten HMD committees and has chaired over half of said committees.

Amy Bohnert
Amy S. B. Bohnert, Ph.D., M.H.S., is an investigator with the Department of Veterans Affairs Center for Clinical Management Research (CCMR), an HSR&D Center of Innovation, and an Associate Professor with tenure in the Department of Psychiatry at the University of Michigan. She obtained a PhD in Public Health from the Johns Hopkins Bloomberg School of Public Health, with a focus on mental health epidemiology, and completed a fellowship in health services research with CCMR.

Dr. Bohnert is an expert in the design of observational studies using electronic health record and mortality databases, particularly when applied to the topics of overdose, suicide, and prescribing behavior. She has led VA-, NIH-, and CDC-funded projects on these topics, which has resulted in over 100 publications. Her studies of Veterans’ overdose and suicide mortality have been published in the Journal of the American Medical Association, the British Medical Journal, and the American Journal of Psychiatry. She was the senior author on a study examining concurrent opioid and benzodiazepine prescribing in connection to Veterans’ overdose deaths.

Dr. Bohnert has served in a scientific advisory role to the Centers for Disease Control and Prevention, including as a member of the expert panel for the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain, to the Food and Drug Administration, and to the Michigan Prescription Drug and Opioid Abuse Task Force. Her overall goal is to improve the quality of life and treatment outcomes for individuals who struggle with addiction and mental health conditions.

Tobias Gerhard
Tobias Gerhard is Associate Professor of Pharmacy and Epidemiology at Rutgers University. He serves as the inaugural Director of the Rutgers Center for Pharmacoepidemiology and Treatment Science (PETS) where he conducts research on use, safety, and outcomes of prescription drugs. He is interested in novel epidemiological methods and their applications in the analysis of large clinical and administrative databases. Dr. Gerhard’s research has been funded by NIMH, PCORI, AHRQ, and several foundations. His work has been recognized with a Young Investigator Award from the Brain and Behavior Research Foundation and a New Investigator Award from the American Society of Clinical Psychopharmacology. Dr. Gerhard is a Fellow of ISPE and serves as a Special Government Employee on various FDA Advisory Committees.
Miguel Hernan
Miguel Hernán, MD, DrPH, studies causal inference methods and implements them to evaluate strategies for the treatment and prevention of disease. Together with collaborators in several countries, he designs analyses of health care databases, epidemiologic studies, and randomized trials. Dr. Hernán teaches clinical data science at the Harvard Medical School, clinical epidemiology at the Harvard-Massachusetts Institute of Technology Division of Health Sciences and Technology, and causal inference methodology at the Harvard T.H. Chan School of Public Health, where he is the Kolokotrones professor of biostatistics and epidemiology and where he has mentored dozens of doctoral students and postdoctoral fellows. His book Causal Inference, co-authored with James Robins and freely available online, is used in graduate programs throughout the world. Dr. Hernán is a fellow of the American Association for the Advancement of Science, past chair of the American Statistical Association Section on Statistics in Epidemiology, past associate editor of the Journal of the American Statistical Association and of Biometrics, associate editor of the American Journal of Epidemiology, and an editor of Epidemiology. He has served on several committees of the National Academies of Sciences, Engineering, and Medicine.
Van L. King, Jr.
Van Lewis King, MD is a Professor at UT Health San Antonio. Dr. King received his MD from the University of Rochester School of Medicine and Dentistry. He completed his general psychiatry training at the Massachusetts General Hospital. He was a member of the faculty at the Johns Hopkins University School of Medicine for 25 years serving as the medical director of Addiction Treatment Services and the Center for Addiction and Pregnancy, prior to accepting a professorship at UT Health San Antonio in 2016. He is a highly trained general psychiatrist specializing in treatment of severe and chronic opioid use disorder. In addition to his daily clinical activities, he has been involved extensively in NIDA funded treatment services research related to patients with severe substance use disorder and how best to manage these frequently chronic conditions. He is a nationally recognized treatment expert in patients with severe opioid dependence (including pregnancy) and co-occurring psychiatric conditions and is developing a new program at UT Health San Antonio to treat adults with a wide variety of substance use disorder problems using the award-winning Adaptive Stepped Care treatment model he and his colleagues developed over the past 20 years. He is also active in Texas delivering buprenorphine maintenance waiver trainings to promote wider use of this medication to assist in treatment of patients with opioid use disorder.
Roger J. Lewis
Roger Lewis is a Professor of Emergency Medicine at the David Geffen School of Medicine at UCLA, Interim Chief Medical Information Officer for the Los Angeles County Department of Health Services, and Chair (on leave) of the Department of Emergency Medicine at Harbor-UCLA Medical Center. Dr. Lewis’s expertise centers on adaptive and Bayesian clinical trials, including platform trials; translational, clinical, health services and outcomes research; interim data analysis; data monitoring committees; and informed consent in emergency research studies.

Dr. Lewis has served as a grant reviewer for the Agency for Healthcare Research and Quality (AHRQ), the Canadian Institutes of Health Research (CIHR), the Centers for Disease Control and Prevention (CDC), the Medical Research Council of the UK (MRC), the National Cancer Institute of France, the National Institutes of Health (NIH), the Patient Centered Outcomes Research Institute (PCORI) and foundations. He has also served as a member of the Medicare Evidence Development & Coverage Advisory Committee of the Centers for Medicare & Medicaid Services and as the chair of data and safety monitoring boards (DSMB) for both federally-funded and industry-sponsored clinical trials, including international trials. He is a research methodology reviewer for JAMA and an editor of the JAMA series entitled “JAMA Guides to Statistics and Methods.” He has served as a content reviewer for many other peer reviewed journals. He has authored or coauthored over 240 original research publications, reviews, editorials, and chapters.

In 2009, Dr. Lewis was elected to membership in the National Academy of Medicine. He is a Past President of the Society for Academic Emergency Medicine (SAEM), currently a member of the Board of Directors for the Society for Clinical Trials, and the Senior Medical Scientist at Berry Consultants, LLC, a group that specializes in adaptive clinical trials.
Jessica S. Merlin
Dr. Merlin completed an undergraduate degree in biological sciences with an additional major in history and policy from Carnegie Mellon University and an MD from the University of Pennsylvania. She stayed at the University of Pennsylvania for her residency in internal medicine and fellowship in infectious diseases before completing palliative care fellowship at the Mt. Sinai School of Medicine. In 2011, Dr. Merlin joined the faculty of the University of Alabama at Birmingham (UAB) Department of Medicine as an Assistant Professor in Infectious Diseases and Gerontology, Geriatrics, and Palliative Care. She stayed at UAB for six years before accepting her current position as an Associate Professor in General Internal Medicine and Infectious Diseases. Dr. Merlin has directed chronic pain clinics embedded in HIV patient-centered medical homes, first at the 1917 Clinic at UAB and now at the Pittsburgh AIDS Center for Treatment at Pitt. Her research mirrors her clinical work, and focuses on chronic pain in people living with HIV, and more generally, individuals with comorbid mental illness and addiction. She has completed an NIH K23 career development award to develop and test a behavioral intervention for chronic pain in patients with HIV during which she also received her PhD in health behavior, and was recently awarded an R01 to test its efficacy and mechanisms. She has several other ongoing projects investigating the pathophysiology of chronic pain in people living with HIV via mechanisms such as inflammation and pain sensitivity, clinical epidemiology of chronic pain in patients with HIV and management approaches to concerning behaviors that arise among individuals on long-term opioid therapy, and the role of marijuana in chronic pain management. She has been recognized nationally for her work, including a Young Investigator award and an Inspirational Leader Under 40 Award from the American Academy of Hospice and Palliative Medicine and the John C. Liebeskind Early Career Scholar Award from the American Pain Society.
Susan M. Paddock
Susan Paddock is a senior statistician at the RAND Corporation and a faculty member at the Pardee RAND Graduate School. Her research interests include substance abuse treatment, mental health, and quality of health care. She was involved in an external evaluation of the quality of care provided by the Veterans Health Administration to veterans with serious mental illness or substance use disorders and she served on the National Academies of Sciences, Engineering, and Medicine’s Committee to Evaluate the Department of Veterans Affairs’ Mental Health Services. She has also examined the quality of care for PTSD and depression in the Military Health System and assessed associations between process-of-care measures and mortality in veterans with opioid use disorders. Dr. Paddock’s statistical research focuses on Bayesian methods, hierarchical modeling, longitudinal data analysis, and missing data techniques. Paddock is the principal investigator of a project sponsored by the National Institute on Alcohol Abuse and Alcoholism to develop methods for analyzing data arising from studies of group therapy–based interventions. She is the co-principal investigator of a project to conduct analyses related to the Medicare Advantage Plan Ratings for Quality Bonus Payments. She previously led a project sponsored by the Agency for Healthcare Research and Quality to improve the science of public reporting of healthcare provider performance. Paddock has served on editorial boards for the Annals of Applied Statistics, Journal of the American Statistical Association, and Medical Care, and is a Fellow of the American Statistical Association. She received her Ph.D. in statistics from Duke University.

Events



Location:

Keck Center
500 5th St NW, Washington, DC 20001
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:  Carolyn Fulco
Contact Email:  cfulco@nas.edu
Contact Phone:  (202) 334-3312

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

Publication(s) resulting from the event:

-

Event Type :  
-

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:  Carolyn Fulco
Contact Email:  cfulco@nas.edu
Contact Phone:  (202) 334-3312

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:

Brian L. Strom
Amy Bohnert
Tobias Gerhard
Miguel Hernán (day 2 only
via phone)
Van Lewis King Jr.
Roger J. Lewis (day 1 only)
Jessica S. Merlin
Susan Paddock

The following topics were discussed in the closed sessions:

Reviewed drafts of chapters 1-3, discussed plan for chapter 4.

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

Chapters and table of contents

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

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
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:  Bernice Chu
Contact Email:  bchu@nas.edu
Contact Phone:  (202) 334-1819

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:

Brian L. Strom
Amy Bohnert
Tobias Gerhard
Miguel Hernán
Van Lewis King
Jr.
Roger J. Lewis
Jessica S. Merlin
Susan Paddock

The following topics were discussed in the closed sessions:

Conflict of Interest/Bias discussion;
Determined if the committee’s composition is sufficient for the task;
Began a discussion of the committee’s approach and developed a report outline.

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

Briefing book with background materials

Date of posting of Closed Session Summary:
January 14, 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.