F

Committee Biosketches

Ruth R. Faden, Ph.D., M.P.H. (Co-Chair), is the Philip Franklin Wagley Professor of Biomedical Ethics and executive director of the Johns Hopkins Berman Institute of Bioethics. She is also a senior research scholar at the Kennedy Institute 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 commissions, 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 departments 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 Training Program in Clinical Investigation, and co-directed the epidemiology doctoral



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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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271 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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273 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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275 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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