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F
Committee Biosketches
Ruth R. Faden, Ph.D., M.P.H. (Co-Chair), is the Philip Franklin Wagley Profes-
sor of Biomedical Ethics and executive director of the Johns Hopkins Berman
Institute of Bioethics. She is also a senior research scholar at the Kennedy Insti -
tute of Ethics of Georgetown University. Dr. Faden is the author and editor of
numerous books and articles on biomedical ethics and health policy, including
A History and Theory of Informed Consent (with Tom L. Beauchamp), AIDS,
Women, and the Next Generation (Ruth R. Faden, Gail Geller, and Madison
Powers, editors), HIV, AIDS and Childbearing: Public Policy, Private Lives (Ruth
R. Faden and Nancy E. Kass, editors). Dr. Faden is a member of the Institute of
Medicine and a Fellow of the Hastings Center and the American Psychological
Association. She has served on several national advisory committees and com -
missions, including the President’s Advisory Committee on Human Radiation
Experiments, which she chaired. Current research interests include bioethics and
public policy; ethics and cellular engineering; ethics and neuroscience; ethics
and bioterrorism; ethics, genetics, and public policy; research ethics; and justice.
Steven N. Goodman, M.D., M.H.S., Ph.D. (Co-Chair), is associate dean for
clinical and translational research and professor of medicine and health policy
and research at Stanford University School of Medicine. Before joining Stanford
in 2011, Dr. Goodman was professor of oncology in the division of biostatistics
of the Johns Hopkins Kimmel Cancer Center, with appointments in the depart -
ments of pediatrics, biostatistics, and epidemiology in the Johns Hopkins Schools
of Medicine and Public Health. He was also on the core faculties of the Johns
Hopkins Center for Clinical Trials, Berman Bioethics Institute, Graduate Train -
ing Program in Clinical Investigation, and co-directed the epidemiology doctoral
269
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270 STUDYING THE SAFETY OF APPROVED DRUGS
program. He is the editor of Clinical Trials: Journal of the Society for Clinical
Trials and is statistical and associate editor of the Annals of Internal Medicine,
since 1987. He served on the Institute of Medicine’s the Committee to Review
the Health Effects in Vietnam Veterans of Exposure to Herbicides: Second Bien -
nial Update, Committee to Review the Evidence Regarding the Link between
Exposure to Agent Orange and Diabetes, Immunization Safety Review Commit -
tee, the Committee on Alternatives to the Daubert Standards ,and the Committee
on Treatment of Post-traumatic Stress Disorder in Veterans. Dr. Goodman also
served on the Surgeon General’s committee to write the 2004 report on the Health
Consequences of Smoking. He is a scientific advisor to the Medical Advisory
Panel of the National Blue Cross/Blue Shield Technology Evaluation Center, and
was appointed to the Methodology Committee of the Patient Centered Outcomes
Research Institute. Dr. Goodman received a B.A. from Harvard, an M.D. from
New York University, trained in Pediatrics at Washington University in St. Louis,
and received an M.H.S. in biostatistics, and Ph.D. in epidemiology from Johns
Hopkins University. He writes and teaches on evidence evaluation and inferential,
methodologic, and ethical issues in epidemiology and clinical research.
Alasdair Breckenridge, M.D., FRCP, is chairman of the United Kingdom
Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA
is the executive agency of the UK Department of Health, which is responsible
for protecting and promoting public health and patient safety by ensuring that
medicines, health care products, and medical equipment meet appropriate stan -
dards of safety, quality, performance, and effectiveness and are used safely. In
2004, he was awarded a knighthood for his services to medicine in recognition
of his role in ensuring that British patients receive safe medical treatment. Dr.
Breckenridge has played a leading role in monitoring the safety of medicines for
many years. He previously was chairman of the UK Committee on the Safety of
Medicines (CSM) and was a member of the CSM Adverse Reactions Group and
Subcommittee on Adverse Reactions to Vaccines and Immunization. He is a for-
mer professor of clinical pharmacology at the University of Liverpool and headed
its Department of Pharmacology and Therapeutics for 26 years. Dr. Breckenridge
has also been both a member and chairman of a regional health authority and a
member of a local health authority. His research interests include the pharmacol -
ogy of HIV drugs.
Lisa Egbuonu-Davis, M.D., M.P.H., M.B.A., is an executive adviser in Booz
Allen Hamilton’s health care practice. Her focus includes business implications
of health care reform, strategies to support the product-value proposition from
development through commercialization, and practices to ensure compliance
and transparency while delivering business impact. Dr. Egbuonu-Davis joined
Booz Allen after 18 years in the pharmaceutical industry, including 13 years at
Pfizer Pharmaceuticals, where she served as vice president for global outcomes
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APPENDIX F
research and vice president of US Medical. She built and led a multinational
health economic and outcomes research function, developing and implementing
processes to provide clinical and comparative-effectiveness research and gener-
ate data needed to support pricing, reimbursement, formulary coverage, and
acceptance. She has been involved in comparative-effectiveness research policy,
previously serving as a member of the National Advisory Council for the Agency
for Healthcare Research and Quality and the Steering Committee for the Centers
for Research and Education on Therapeutics. She played a leadership role in the
integration of medical–regulatory and clinical research functions during several
mergers. She created a US field-based medical team that supported clinical
research and communication with medical opinion leaders. As vice present of
US Medical, she had responsibility for marketed-product clinical and outcomes
research, medical information, public-health and academic partnerships, and
regulatory promotional review. Dr. Egbuonu-Davis earned a B.S. in biology from
the Massachusetts Institute of Technology, an M.B.A. in health care management
from Wharton, and an M.D. and M.P.H. from Johns Hopkins and is a fellow of
the American Academy of Pediatrics.
Miguel A. Hernán, M.D., Sc.M., Dr.P.H., is professor of epidemiology at Har-
vard School of Public Health and an affiliated faculty member of the Harvard–
Massachusetts Institute of Technology Division of Health Sciences and Technol -
ogy. He is an editor of Epidemiology and a Fellow of the American Association
for the Advancement of Science. He writes and teaches on methods of causal
inference, including comparative effectiveness of policy and clinical interven-
tions. His current research interests include the optimal use of antiretroviral
therapy for HIV disease, clinical strategies for the reduction of mortality in people
who have kidney failure, and the effects of lifestyle and pharmacologic interven -
tions in reducing the incidence of cardiovascular disease.
Grace M. Lee, M.D., M.P.H., is an associate professor of population medicine
and pediatrics at the Harvard Pilgrim Health Care Institute, Harvard Medical
School, and Children’s Hospital Boston. She is also an assistant professor of
pediatrics in the Division of Infectious Diseases at Children’s Hospital Boston.
Dr. Lee’s research focuses on vaccine economics, vaccine safety, and infectious-
diseases epidemiology. She recently completed a study funded by the Centers for
Disease Control and Prevention (CDC) on emerging gaps in vaccine financing
for underinsured children in the United States. She is working on a study funded
by the Agency for Healthcare Research and Quality (AHRQ) to determine the
potential effects and cost-effectiveness of using a group A streptococcal vaccine
and a CDC-funded study of influenza-vaccine safety. Dr. Lee joined the faculty of
Harvard Medical School, Harvard Pilgrim Health Care, and Children’s Hospital
Boston in 2003 after completing an AHRQ postdoctoral fellowship. She received
her M.D. from the University of Pennsylvania School of Medicine and her M.P.H.
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272 STUDYING THE SAFETY OF APPROVED DRUGS
from the Harvard School of Public Health. She completed her pediatric residency
and subspecialty training in pediatric infectious diseases and pediatric health
services research at Children’s Hospital Boston. Dr. Lee is currently serving
on the Institute of Medicine Committee on Review of Priorities in the National
Vaccine Plan.
Michelle Mello, Ph.D., J.D., M.Phil., is a professor of law and public health
in the Department of Health Policy and Management of the Harvard School of
Public Health. She holds a J.D. from the Yale Law School; a Ph.D. in health
policy and administration from the University of North Carolina at Chapel Hill;
an M.Phil. from Oxford University, where she was a Marshall Scholar; and a
B.A. from Stanford University. Dr. Mello conducts empirical research on issues
at the intersection of law, ethic, and health policy. She is the author of more than
100 articles and book chapters on the medical-malpractice system, medical errors
and patient safety, research ethics, the obesity epidemic, pharmaceuticals, clini -
cal ethics, and other topics. Among other current projects, Dr. Mello is studying
disclosure of and compensation for medical injuries as the recipient of a Robert
Wood Johnson Foundation (RWJF) Investigator Award in Health Policy Research,
and she is also the recipient of the Alice S. Hersh New Investigator Award from
AcademyHealth for contributions to the field of health-services research. Dr.
Mello is director of the Program in Law and Public Health of the Harvard School
of Public Health and chair of the school’s institutional review board. She teaches
courses in public-health law and public-health ethics. Dr. Mello serves as a key
consultant to RWJF’s Public Health Law Research Program.
Eric M. Meslin, Ph.D., is director of the Indiana University (IU) Center for Bio-
ethics, associate dean for bioethics in the Indiana University School of Medicine,
and professor of medicine, medical and molecular genetics, public health, and
philosophy. He also codirects the IU Center for Law, Ethics and Applied Research
in Health Information (CLEAR) and the IU-Moi Academic Research Ethics
Partnership, an innovative bioethics-research training program in Eldoret, Kenya.
He came to Indiana in 2001 from Washington, DC, where he directed bioethics
research for the Ethical, Legal and Social Implications program of the Human
Genome Project and then served as executive director of the US National Bio -
ethics Advisory Commission established by President Clinton. Born in Canada,
Dr. Meslin received his B.A. in philosophy from York University in Toronto and
his M.A. and Ph.D. from the Bioethics Program in Philosophy of the Kennedy
Institute of Ethics at Georgetown University. He has held academic positions at
the University of Toronto (1988–1996), as a visiting fellow at Green College,
Oxford University (1994–1995), and as professor-at-large at the University of
Western Australia (2008–2010). He has more than 150 published articles and
book chapters on topics from international health research to science policy. His
most recent book is The Sage Handbook of Health Care Ethics (coedited with
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APPENDIX F
Ruth Chadwick and Henk Ten Have, published in 2011). Dr. Meslin sits on sev -
eral boards and committees, including the Institute of Medicine’s Committee on
Ethical and Scientific Issues in Studying the Safety of Approved Drugs, the Board
of Directors of the Indiana Public Umbilical Cord Blood Bank, and the Board
of Directors of Genome Canada. On May 9, 2007, he was appointed a Chevalier
de L’Order Nationale du Mérite (Knight of the National Order of Merit) by the
French ambassador to the United States for his contributions to French bioethics
policy.
Larry I. Palmer, L.L.B., (retired June 2011), is professor of law emeritus at
Cornell University. He previously served as a professor of law at Virginia Com -
monwealth University and professor of law at the William & Mary Law School.
He also has appointments at the College of William & Mary in the Marshall-
Wythe School of Law as a law professor and in the Thomas Jefferson Program
in Public Policy’s Schroder Center for Healthcare Policy as a research professor.
He served 4 years as the Endowed Chair in Urban Health Policy at the University
of Louisville and 27 years at Cornell University as law professor, vice president,
and vice provost. He has been a visiting professor at Georgetown University and
the University of Virginia. He is the author of Endings and Beginnings: Law,
Medicine, and Society in Assisted Life and Death, Law, Medicine and Social
Justice, and numerous articles dealing with law, medicine, and health policy. He
is also the executive producer and author of the study guide of the prizewinning
educational video Susceptible to Kindness: Miss Evers’ Boys and the Tuskegee
Syphilis Study. He was a director of the Hastings Center in Garrison, New York,
and a member of the National Institute on Alcohol Abuse and Alcoholism Advi-
sory Council. Previously, Mr. Palmer served as a director of the National Patient
Safety Foundation, a trustee of the Phillips Exeter Academy, and a member of
the American Bar Association’s Special Committee on Bioethics and Law. He
has been a member of the Institute of Medicine Committee on Ethical Consider-
ations for Revisions to DHHS Regulations for Protection of Prisoners Involved
in Research and Committee on Establishing a National Cord Blood Stem Cell
Bank Program.
Bruce M. Psaty, M.D., Ph.D., M.P.H., is a professor of medicine, epidemiol-
ogy, and health services; co-director of the Cardiovascular Health Research
Unit of the University of Washington; an investigator at Group Health Research
Institute, Group Health Cooperative; and a practicing general internist at Harbor-
view Medical Center, Seattle, WA. He received his M.D. and a Ph.D. in English
language and literature from Indiana University and his M.P.H. in epidemiology
from the University of Washington. His research interests include cardiovascular
epidemiology, hypertension, diabetes, epidemiological methods, drug safety,
pharmacoepidemiology, genetics, genomics, and pharmacogenetics. Dr. Psaty
is the principal investigator on several large epidemiologic studies and has had
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274 STUDYING THE SAFETY OF APPROVED DRUGS
major roles as a cardiovascular disease epidemiologist at the coordinating centers
of National Institutes of Health (NIH)–funded multi-center studies, including
the Cardiovascular Health Study, the Multi-Ethnic Study of Atherosclerosis, and
the Women’s Health Initiative. In these settings and others, he has used case-
control, cohort, clinical-trial and meta-analytic methods to evaluate the risks and
benefits of a variety of medications, including hormone therapy, non-steroidal
anti-inflammatory agents, and drugs used to treat hypertension, diabetes, dys -
lipidemia, asthma, heart failure, atrial fibrillation, osteoporosis, chronic pain,
and other conditions as well as drug-gene interactions that may influence the
occurrence of the risks or benefits of selected medications. Recently, Dr. Psaty
collaborated with investigators from other national and international cohort stud -
ies to establish the CHARGE (Cohorts for Heart and Aging Research in Genomic
Epidemiology) consortium, which has published more than 70 meta-analyses of
genome-wide association studies of a variety of phenotypes. Dr. Psaty has served
on various NIH working groups, data-safety monitoring committees, review
groups and study sections, including as chair of the NIH Cardiovascular Disease
and Sleep Epidemiology Study Section (2004–2006), Institute of Medicine’s
Committee on the Assessment of the US Drug Safety System (2005–2006),
the Executive Committee of the National Heart, Lung, and Blood Institute’s
Strategic Planning Effort (2006–2007), and the Scientific Advisory Board of
the Netherlands Biobank Infrastructure (2010–present). In 2005, he received the
University of Washington Outstanding Public Service Award for his work on drug
safety. The American Heart Association’s Epidemiology and Prevention Council
selected Dr Psaty as the Remington Methodology Lecturer (2004) and as the
Ancel Keys Memorial Lecturer (2009). Elected memberships include American
Epidemiological Society, Association of American Physicians, and fellow of the
American Heart Association. Currently, Dr. Psaty is a member of the FDA Sci -
ence Board and the Safety Science Committee of the Mini-Sentinel Initiative.
He also teaches and mentors students, fellows and junior faculty in medicine and
epidemiology. With more than 500 articles, editorials and commentaries in the
medical literature, Dr. Psaty publishes regularly, serves on the editorial board of
several journals, and is a contributing writer at JAMA.
Thomas R. Ten Have, Ph.D., M.P.H.,* was a professor of biostatistics, Perelman
School of Medicine, University of Pennsylvania, director of the Biostatistics-Data
Core, and coinvestigator of the National Institute of Mental Health–sponsored
Advanced Center for Interventions and Services Research for Depression in the
Aged. In the latter capacity, Dr. Ten Have was collaborating on trials involv-
ing the prevention of suicide in elderly primary-care patients; the treatment of
postmenopausal women with estrogen for depression; the treatment of substance
abuse, anxiety, and depression in elderly veterans; and disparities of screening
*Deceased May 1, 2011.
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APPENDIX F
and treatment for mental-health disorders in participants of color. In addition to
investigating methods for accommodating dropout in longitudinal studies, Dr.
Ten Have focused on other methodologic issues, including accounting for differ-
ent sources of nonadherence in randomized trials, such as patient and physician
nonadherence to randomized treatment regimens; analyses of data from practice-
randomized studies; and designs and analyses of clinical trials of complex mul -
ticomponent, adaptive treatment regimens. His previous Institute of Medicine
service included membership on the Committee on NASA’s Bioastronautics
Critical Path Roadmap. Dr. Ten Have was a member of the American Statistical
Association, the Institute of Mathematical Statistics, the International Biometrics
Society, the Society for Epidemiological Research, and the American Public
Health Association. He was associate editor of Biometrics and of the Journal
of the Royal Statistical Society, Series C, statistical consulting editor of Bipolar
Disorders, and guest editor for Statistics in the Biosciences.
William K. Vaughan, B.A., has recently retired as a senior policy analyst in the
health sector for Consumers Union, the nonprofit, independent publisher of Con-
sumer Reports. Starting in 1965, he worked for various members of the House of
Representatives Committee on Ways and Means; he retired in 2001 as Subcom-
mittee on Health staff director for the minority. From 2003 to May 2005, he was
director of government relations for Families USA, a national health-advocacy
organization.
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