COMMITTEE ON THE ASSESSMENT OF THE US DRUG SAFETY SYSTEM
Sheila Burke (Chair), MPA, RN, is deputy secretary and chief operating officer of the Smithsonian Institution. Ms. Burke is also the vice chair of the Robert Wood Johnson Health Policy Fellowships Board. She is a member of the Medicare Payment Advisory Commission and serves as chair of the Kaiser Family Foundation, the Kaiser Commission on the Future of Medicaid and the Uninsured, WellPoint Health Networks, Chubb Corporation, and the University of San Francisco. She is an adjunct lecturer in public policy at the Kennedy School of Government, Harvard University. She previously was executive dean and a lecturer in public policy at Harvard University’s John F. Kennedy School of Government. From 1986 to 1996, Ms. Burke was chief of staff to Senate Majority Leader Robert Dole. In 1995, she was also elected to serve as secretary of the Senate. Before joining Senator Dole’s personal office, she served the Senate Committee on Finance as a professional staff member and as deputy staff director. Early in her career, she worked as a staff nurse in Berkeley, California, and was director of program and field services for the National Student Nurses Association in New York. She received her MPA from Harvard University and her BS in nursing from the University of San Francisco. Ms. Burke is a member of the Institute of Medicine.
David Blumenthal, MD, MPP, is the Samuel O. Thier Professor of Medicine and Professor of Health Care Policy at Harvard Medical School and direc-
tor of the Institute for Health Policy at Massachusetts General Hospital and Partners HealthCare System. Dr. Blumenthal is also the director of the Harvard University Interfaculty Program for Health Systems Improvement. Harvard University receives about $1 million per year from the Merck Foundation to support the research and convening activities of the Program for Health System Improvement. Dr. Blumenthal serves on several editorial boards, including those of the American Journal of Medicine and the Journal of Health Politics, Policy and Law. He is a national correspondent for the New England Journal of Medicine. Dr. Blumenthal was the founding chairman of AcademyHealth (formerly the Academy for Health Services Research and Health Policy), the national organization of health services researchers, and is a member of its board of directors. During the late 1970s, he was a professional staff member on Senator Edward Kennedy’s Subcommittee on Health and Scientific Research. Dr. Blumenthal previously was the chair of the Institute of Medicine (IOM) Committee on Department of Veterans Affairs Pharmacy Formulary Analysis. His research interests include academic-industrial relationships in the life sciences, quality management in health care, the role and influence of health information technology, determinants of physician behavior, and access to health services. He received his MD and his MPP from Harvard University. Dr. Blumenthal is a member of the IOM.
Sir Alasdair Breckenridge, CBE, is chairman of the UK Medicines and Healthcare Products Regulatory Agency (MHRA). MHRA is the executive agency of the UK Department of Health that is responsible for protecting and promoting public health and patient safety by ensuring that medicines, healthcare products, and medical equipment meet appropriate standards of safety, quality, performance, and effectiveness and are used safely. In 2004, he was awarded a knighthood for his service to medicine in recognition of his role in ensuring that British patients receive safe medical treatment. Prof. Breckenridge has played a leading role in monitoring the safety of medicines for many years. He previously was the chairman of the UK Committee on the Safety of Medicines (CSM) and was a member of the CSM Adverse Reactions Group and the Subcommittee on Adverse Reactions to Vaccines and Immunisation. He is a former professor of clinical pharmacology at the University of Liverpool and headed its Department of Pharmacology and Therapeutics for 26 years. Prof. Breckenridge has been both a member and chairman of a regional health authority and a member of a local health authority. His research interests include the pharmacology of HIV drugs.
R. Alta Charo, JD, is the Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin Law School and its Medical School’s Department of Medical History & Bioethics. She teaches in the areas of Food and
Drug Administration law, biotechnology law, bioethics, and reproductive rights. In addition, she has served on the UW Hospital clinical-ethics committee, the UW institutional review board for the protection of human subjects in medical research, and the UW Bioethics Advisory Committee. Prof. Charo is the author of nearly 100 articles, book chapters, and government reports on such topics as voting rights, environmental law, medical-genetics law, reproductive rights law, science policy and bioethics. She is a member of the board of directors of the Alan Guttmacher Institute and the program board of the American Foundation for AIDS Research (amfAR). She serves on several expert advisory boards of organizations with an interest in stem-cell research, including WiCell and the California Institute for Regenerative Medicine. She has served as a consultant to the Institute of Medicine (IOM) and the National Institutes of Health (NIH) former Office of Protection from Research Risks. In 1994, Prof. Charo served on the NIH Human Embryo Research Panel, and from 1996–2001, on the presidential National Bioethics Advisory Commission where she participated in drafting its reports on such topics as cloning, stem cell research, and research ethics. She is a member of the National Research Council (NRC) Board on Life Sciences and the IOM Board on Population Health and Public Health Practices. She currently co-chairs the NRC-IOM Human Embryonic Stem Cell Research Advisory Committee.
Susan Edgman-Levitan, PA, is executive director of the John D. Stoeckle Center for Primary Care Innovation at Massachusetts General Hospital (MGH). She is a lecturer in the Department of Medicine of Massachusetts General Hospital and an associate in health policy at Harvard Medical School. Before going to MGH, Ms. Edgman-Levitan was the founding president of the Picker Institute. She has been the coprincipal investigator on the Harvard Consumer Assessment of Health Plans Study (CAHPS) from 1995 to the present, which is funded by the Agency for Healthcare Research and Quality. She has served as chair of the Institute for Healthcare Improvement (IHI) Breakthrough Series Collaborative on Improving Service Quality and is the IHI fellow for patient and family-centered care. She is an editor of Through the Patient’s Eyes (a book on creating and sustaining patient centered care), The CAHPS Improvement Guide, and has written many papers and other publications on patient-centered care. She serves on several boards, including those of the National Patient Safety Foundation (NPSF), the Center for Information Therapy, the Foundation for Informed Medical Decision Making, Planetree, and the American Academy on Physician and Patient. She has co-chaired the annual NPSF congress on patient safety since 2002. She received the Distinguished Alumni Award from the Duke Physician Assistant Program and was inducted into the Duke University Medical Center Hall of Fame in 2004. She received her PA degree from Duke University.
Susan Ellenberg, PhD, is professor of biostatistics and associate dean for clinical research at the University of Pennsylvania School of Medicine. Previously, Dr. Ellenberg was director of the Office of Biostatistics and Epidemiology at the Center for Biologics Evaluation and Research of the Food and Drug Administration (FDA), chief of the Biostatistics Research Branch in the Division of AIDS of the National Institute of Allergy and Infectious Diseases, and mathematical statistician in the Biometrics Research Branch of the Cancer Therapy Evaluation Program at the National Cancer Institute. Before her federal government service, she had positions at the EMMES Corporation and the George Washington University. She serves as associate editor of Clinical Trials and of the Journal of the National Cancer Institute. Dr. Ellenberg is a fellow of the American Statistical Association and the American Association for the Advancement of Science and an elected member of the International Statistical Institute. Her recent book on clinical trials data monitoring committees, of which Thomas Fleming (University of Washington) and David DeMets (University of Wisconsin) were coauthors, was named WileyEurope Statistics Book of the Year for 2002. Dr. Ellenberg’s research interests include issues in the design and analysis of clinical trials and assessment of medical product safety, particularly focusing on efficient trial designs, interim monitoring and the operation of data monitoring committees, evaluation of surrogate endpoints, ethical issues in clinical research, and special issues in trials of cancer and AIDS therapies and of vaccines. She serves on two National Institutes of Health-sponsored data monitoring committees, and one for Curagen. She received her PhD in mathematical statistics from George Washington University.
Robert D. Gibbons, PhD, is a professor of biostatistics and psychiatry and director of the Center for Health Statistics at the University of Illinois at Chicago. He received his doctorate in statistics and psychometrics from the University of Chicago in 1981. He received a Young Scientist Award from the Office of Naval Research (1981), a Career Scientist Award from the National Institutes of Health (NIH) (1995), and numerous other NIH grants. His research spans medical, biologic, and environmental statistics, with emphasis on statistical problems in mental health, health services research, longitudinal data analysis, and environmental regulatory statistics. Dr. Gibbons is a fellow of the American Statistical Association and received two the Youden Prizes for statistical contributions to chemistry and the Harvard Award for contributions to psychiatric epidemiology and biostatistics. Dr. Gibbons has served on several Institute of Medicine (IOM) committees, including the Committee on Halcion and the Committee on Organ Procurement and Transplantation, and served on the IOM Board on Health Sciences Policy. He has written over 150 peer-reviewed papers and four books. Dr. Gibbons recently has conducted statistical work focusing on the reanalysis
of data on selective serotonin reuptake inhibitors and suicide. Dr. Gibbons is a member of the IOM.
George Hripcsak, MD, MS, is professor and vice chair of Columbia University’s Department of Biomedical Informatics, associate director of medical informatics services for New York-Presbyterian Hospital, and senior informatics advisor at the New York City Department of Health and Mental Hygiene. He led the effort to create the Arden Syntax, a language for representing health knowledge that has become a national standard. His Applied Informatics project—funded by the US Department of Commerce to link the medical center, a home care agency, and the New York City Department of Health to improve inner-city tuberculosis care—won the National Information Infrastructure award. Dr. Hripcsak’s current research focus is on the clinical information stored in electronic medical records. Using data mining techniques, such as machine learning and natural language processing, he is developing the methods necessary to support clinical research and patient safety initiatives. Dr. Hripcsak was a elected fellow of the American College of Medical Informatics in 1995 and served on the Board of Directors of the American Medical Informatics Association (AMIA). As chair of the AMIA Standards Committee, he coordinated the medical-informatics community response to the Department of Health and Human Services for the health-informatics standards rules under the Health Insurance Portability and Accountability Act of 1996. He chaired the Biomedical Library and Informatics Review Committee of the National Library of Medicine through 2005. He is associate editor of the Journal of the American Medical Informatics Association and of Computers in Biology and Medicine, and he is an editorial board member of the Journal of Biomedical Informatics. He received his MD and his MS in biostatistics from Columbia University.
David Korn, MD, is senior vice president for biomedical and health sciences research at the Association of American Medical Colleges. He served as Carl and Elizabeth Naumann Professor and dean of the Stanford University School of Medicine from 1984 to 1995, and as vice president of Stanford University from 1986 to 1995. Earlier, he had served as professor and chairman of the Department of Pathology at Stanford from 1968. Dr. Korn was appointed by President Ronald Reagan as chairman of the National Cancer Advisory Board from 1984 to 1991. He has been chairman of the Stanford University Committee on Research, president of the American Association of Pathologists (now the American Society for Investigative Pathology), president of the Association of Pathology Chairmen; member of the Board of Directors and the Executive Committee of the Federation of American Societies for Experimental Biology, and member of the Board of Directors of the Association of Academic Health Centers. He was also a founder of the
California Transplant Donor Network, the Clinical Research Roundtable of the Institute of Medicine (IOM), and the Association for the Accreditation of Human Research Protection Programs. Dr. Korn has been a member of the editorial boards of the American Journal of Pathology, The Journal of Biological Chemistry, and Human Pathology, and for many years he was an associate editor of the latter. He received his MD from Harvard University. Dr. Korn is a member of the IOM.
David O. Meltzer, MD, PhD, is associate professor of medicine and affiliated faculty of the Department of Economics and Graduate School of Public Policy at the University of Chicago. He is director of the Center for Health and Social Sciences and the Centers for Disease Control and Prevention’s Chicago Center of Excellence in Health Promotion Economics at the University of Chicago. He is codirector of the Section of General Internal Medicine research program, the Robert Wood Johnson Clinical Scholars Program, and the MD/PhD Program in the Social Sciences at the University of Chicago. Dr. Meltzer is a faculty research fellow for the National Bureau of Economic Research. His awards include the Lee Lusted Prize of the Society for Medical Decision Making, the Health Care Research Award of the National Institute for Health Care Management, the Young Investigator Award of the Society for Hospital Medicine, the Robert Wood Johnson Generalist Physician Award, the Eugene Garfield Economic Impact Award from Research America, and the Leaders in General Medicine Award from the Midwest Society for General Internal Medicine. Dr. Meltzer’s research interests include the theoretical foundations of medical cost-effectiveness analysis, the effects of medical specialization and prospective payment systems on the cost and quality of care, and the effects of Food and Drug Administration regulation on innovation in the pharmaceutical industry. He is completing work on a small grant from TAP Pharmaceuticals on risk factors for gastrointestinal bleeding and on a small grant from a consortium of pharmaceutical companies on methods to assess the cost effectiveness of treatment for diabetes. The Center for Health and the Social Sciences at the University of Chicago received about $25,000 from the Merck Foundation last year for general support. Dr. Meltzer received his MD and PhD in economics from the University of Chicago.
Woodrow A. Myers, Jr., MD, MBA, is the former executive vice president and chief medical officer of WellPoint Health Networks. Dr. Myers managed WellPoint’s Healthcare Quality Assurance Division, including medical policy, clinical affairs, and health services operations. He was also responsible for strategic initiatives designed to enhance the healthcare experience for the company’s members and to simplify administration and improve communications with physicians and other healthcare professionals. Be-
fore joining WellPoint, he was director of healthcare management at Ford Motor Company. Dr. Myers also served as the corporate medical director for Anthem Blue Cross Blue Shield, commissioner of health for the state of Indiana, and commissioner of health for New York City. During the time Dr. Myers served as the commissioner of health in the State of Indiana, he advocated on behalf of Ryan White, a young boy afflicted with HIV who wanted to attend school. After a laborious process, Dr. Myers helped to change the law so that Indiana became the sole determiner of who attended school, thereby setting an important legal precedent. Earlier in his career, he was an assistant professor of medicine at the University of California San Francisco and a fellow in critical care medicine at the Stanford University Medical Center. Dr. Myers has received numerous medical and community-service awards and has published extensively on medical issues important to public health. He has served on the Board of Directors of the Stanford Hospital and is a former university trustee. He served as a member of the Harvard University Board of Overseers. He received his MD from Harvard University and his MBA from Stanford University. Dr. Myers is a member of the Institute of Medicine.
Mary K. Olson, PhD, is an associate professor of economics and political economy at Tulane University. Before working at Tulane University, she was associate professor of health policy and administration in the Yale University School of Medicine Department of Epidemiology and Public Health. Dr. Olson has expertise on Food and Drug Administration (FDA) regulation. She has published articles that examine new-drug approval policies, FDA enforcement strategies, FDA advisory committees, the effects of prescription drug user fees on FDA, the effects of faster drug reviews on the safety of new medicines, and the risks associated with novel and less novel drugs. Her research interests include pharmaceutical regulation and new drug safety, and gender-related risks among newly approved drugs. Dr. Olson is completing work on a small grant from the Agency for Healthcare Research and Quality for a project to examine the association between the length of FDA review times and adverse drug reaction counts among the 1990–1998 new-drug approvals. Dr. Olson received her PhD in political economics from Stanford University.
Bruce M. Psaty, MD, PhD, is a professor of medicine, epidemiology, and health services, and co-director of the Cardiovascular Health Research Unit, University of Washington, Seattle, and an affiliate investigator in the Center for Health Studies at Group Health, Seattle, WA. He is the principal investigator on four large epidemiologic studies and has had a major roles in 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. He is the chair of the NIH Cardiovascular Disease and Sleep Epidemiology Study Section and chair of the Group Health Research Committee. Earlier in his career, he was a Robert Wood Johnson Clinical Scholar at the University of Washington. Dr. Psaty is a member of the American Epidemiological Society as well as the American Heart Association Council on Epidemiology and Prevention. In 2005, he received the University of Washington Outstanding Public Service award. He publishes regularly in peer-reviewed journals, including many articles and editorials on the risks and benefits of a variety of drug therapies. Dr. Psaty’s research interests include cardiovascular epidemiology, drug safety, hypertension, epidemiologic methods, pharmacogenetics, and pharmacoepidemiology. He has served on three NIH-funded data monitoring committees. He received his MD and PhD from Indiana University and his MPH from the University of Washington.
Christopher H. Schroeder, MDiv, JD, is Charles S. Murphy Professor of Law and Public Policy Studies and Director of the Program in Public Law at Duke University Law School. He has served as acting assistant attorney general in the Office of Legal Counsel in the US Department of Justice, and as Chief Counsel to the Senate Judiciary Committee. He teaches environmental law; government, business, and public policy; environmental litigation; toxic-substances regulation; and philosophy of environmental protection. He has written on the philosophic foundations of risk regulation and liability, the regulation of toxic substances, American environmental policy, and a variety of topics in public law and theory. He is coauthor of a leading environmental-law casebook (5th edition, 2006), Environmental Regulation: Law, Science, and Public Policy. His most recent book is A New Progressive Agenda for the Public Health and the Environment (2005), coedited with Rena Steinzor. His research interests include risk regulation, democratic theory, legislative institutions and separation of powers. Mr. Schroeder received his BA from Princeton University, his MDiv from Yale University, and his JD from the University of California, Berkeley.
Andy Stergachis, PhD, MS, RPh, is professor of epidemiology, adjunct professor of pharmacy and the former interim chairman of the Department of Pathobiology in the School of Public Health and Community Medicine, University of Washington. He was chairman of the University’s Department of Pharmacy and director of the Program in Pharmaceutical Outcomes Research and Policy. He is affiliated with the University’s Northwest Center for Public Health Practice. Dr. Stergachis has served on the National Institutes of Health Epidemiology and Disease Control Study Section, the Agency for Healthcare Research and Quality Health Systems Research Study Section, committees of the National Committee on Quality Assurance, and the
Institute of Medicine’s Committee on Poison Prevention and Control and Committee to Study the Interactions of Drugs, Biologics, and Chemicals in the US Military. He held several positions with Group Health Cooperative of Puget Sound and served on its Pharmacy and Therapeutics Committee and the board of the Group Health Community Foundation. In 1998, he joined drugstore.com and served as vice president and chief pharmacist; now serves as pharmacy adviser. He cofounded and served as principal of Formulary Resources and serves as a consultant on managed care pharmacy for that company. Dr. Stergachis was consultant to United HealthCare for its pharmacoepidemiology cooperative agreement with the Food and Drug Administration. He was the 1990 American College of Preventive Medicine/Burroughs Wellcome Scholar in Pharmacoepidemiology. The American Association of Pharmaceutical Research Scientists awarded Dr. Stergachis the 1994 Research Achievement Award in Economic, Marketing and Management Sciences. In 1999, he was selected as one of the 50 Most Influential Pharmacists in the United States by American Druggist. He was awarded the 2002 Pinnacle Award by the American Pharmaceutical Association Foundation. He serves as board member of the American Pharmacists Association Foundation and he is a fellow in the International Society for Pharmacoepidemiology. He received his PhD and MS from the University of Minnesota and his BPharm from Washington State University.