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G Committee Biographies Bernard Lo, M.D. (Chair) is professor of medicine and director of the Program in Medical Ethics at the University of California, San Francisco (UCSF). At UCSF, he directs the Research Ethics Component of the Clinical and Translational Sciences Institute, which is funded by the National Insti- tutes of Health (NIH), and he codirects the Policy and Ethics Core, Center for AIDS Prevention Studies. He is national program director of the Green- wall Faculty Scholars Program in Bioethics. He is a member of the Institute of Medicine (IOM), serves on the IOM Council, and has served as chair of the Board on Health Sciences Policy and as chair or member of several IOM committees. He cochairs the Scientific and Medical Accountability Stan- dards Working Group of the California Institute for Regenerative Medicine and serves on the Medicare Evidence Development and Coverage Advisory Committee at the Centers for Medicare and Medicaid Services, the Medi- cal Advisory Panel for the Blue Cross Blue Shield Association Technology Evaluation Center, the Ethics Advisory Committee (uncompensated) for Affymetrix (which develops and supplies genetic research products), and two Data and Safety Monitoring Committees at NIH. In the past he served on the National Bioethics Advisory Committee, the Ethics Working Group of the NIH-sponsored HIV Prevention Trials Network, and the Ethics Committee of the American College of Physicians. Dr. Lo is the author of numerous publications, including Resolving Ethical Dilemmas: A Guide for Clinicians. He is board certified in internal medicine and currently teaches courses on clinical ethics and the responsible conduct of research. Wendy Baldwin, Ph.D., is director of the Population Councilâs Poverty, Gender, and Youth program. Before coming to the council, she served as executive vice president for research (EVPR) at the University of Kentucky, 392
APPENDIX G 393 Lexington. The EVPR is responsible for grant and contract oversight, in- cluding technology transfer and evaluation of conflicts of interest. She also spent three decades at the National Institutes of Health (NIH), completing her service as the deputy director for extramural research, a program that represents more than 80 percent of the NIH budget and that applies conflict of interest policies for researchers who receive NIH funds. Dr. Baldwin, who is a social demographer, has served on the National Research Council Committees on Assessing Behavioral and Social Science Research on Aging and Assessing Interactions Among Social, Behavioral, and Genetic Factors in Health. Lisa Bellini, M.D., is associate dean for graduate medical education and is also vice chair for education in the Department of Medicine, University of Pennsylvania. Her primary responsibilities revolve around directing educa- tional programs for residents and fellows. She is the program director of the Internal Medicine Residency program, which has 150 residents. In her role as vice chair, she is also responsible for overseeing all of the subspe- cialty fellowship programs. She spends a large portion of her time teaching trainees at all levels. Given the concentration of her teaching experiences on inpatient services, Dr. Bellini is responsible for the organization and main- tenance of inpatient medicine services for over 220 beds and 15,000 admis- sions per year. In 2005, she assumed responsibility for all of the graduate medical education for the health system. As associate dean, she oversees the education and training of over 850 residents across 61 different programs. Her primary research interests involve the design, implementation, and evaluation of new educational initiatives. Current interests involve issues related to quality of life for the house staff, including sleep deprivation, depression, burnout, and empathy. Her clinical interests include general pulmonary medicine, particularly advanced lung disease. Lisa A. Bero, Ph.D., is a professor in the Department of Clinical Pharmacy, School of Pharmacy and Institute for Health Policy Studies, School of Medi- cine, University of California, San Francisco (UCSF). She is vice chair in the Department of Clinical Pharmacy and chair of the UCSF Conflict of Interest Committee. She is also a member of the UCSF Academic Senate Vendor Relations Task Force and has served on numerous institutional and inter- national committees related to conflicts of interest. In addition, Dr. Bero is a member of the World Health Organization (WHO) Essential Medicines Committee and has participated in advising on guidelines related to conflict of interest disclosure for the WHO guidelines development process. She is codirector of the San Francisco Branch of the U.S. Cochrane Center; a member of the Steering Group of the Cochrane Collaboration; and editor for the Cochrane Effective Practice and Organization of Care Group, which
394 CONFLICT OF INTEREST is conducting a meta-analysis of the literature on interventions that are used to change the behavior of health care professionals. She was involved in drafting and incorporating international commentary on the Cochrane Collaborationâs Commercial Sponsorship Policy and is currently the fund- ing arbiter for the Cochrane Collaboration. Dr. Bero is a consultant to the British Medical Journal. She is a pharmacologist with primary interests in how clinical and basic sciences are translated into clinical practice and health care policy. Her program of research includes examination of the influences on the design and conduct of clinical research and publication of research findings. She also conducts research on university-industry re- lationships and university conflict of interest policies. Eric G. Campbell, Ph.D., is an associate professor at the Institute for Health Policy and the Department of Medicine at Massachusetts General Hospital and Harvard Medical School. His main research interests lie in understand- ing the effects of academic-industry relationships on the processes and outcomes of biomedical research, investigating the effects of local health care market competition on the activities and attitudes of medical school faculty, and understanding the impact of data sharing and withholding on academic science. In addition, he is researching the role of organizational culture in promoting patient safety, and he is participating in a national evaluation of the use of health information technology for the Office of the National Coordinator of Health Information Technology. Dr. Campbell has published numerous articles in professional journals and has delivered numerous presentations at local, national, and international conferences on health care policy, medical education, and science policy. He served on the Institute of Medicine Committee on Alternative Funding Strategies for the U.S. Department of Defenseâs Biomedical Research Program. James F. Childress, Ph.D., is the John Allen Hollingsworth Professor of Eth- ics at the University of Virginia, where he teaches in the Department of Re- ligious Studies and directs the Institute for Practical Ethics and Public Life. He has served as chair of the Universityâs Department of Religious Studies and as codirector of the Virginia Health Policy Center. He is the coauthor of the widely used and cited textbook Principles of Biomedical Ethics. Dr. Childress was vice chair of the national Task Force on Organ Transplanta- tion and was a member of the presidentially appointed National Bioethics Advisory Commission (1996 to 2001). He has also served on the board of directors of the nonprofit United Network for Organ Sharing (UNOS), the UNOS Ethics Committee, the Recombinant DNA Advisory Commit- tee of the National Institutes of Health (NIH), the Human Gene Therapy Subcommittee of that committee, and several Data and Safety Monitoring Boards for NIH clinical trials. He is a member of ethics advisory panels for
APPENDIX G 395 Roche (on tissue banking and clinical research) and Johnson & Johnson (on stem cell research). He chaired the Institute of Medicine (IOM) Committee on Increasing Rates of Organ Donation, cochaired the National Research Council Subcommittee on Use of Third Party Toxicity Research with Hu- man Test Subjects, and served as a member of IOM committees on assessing genetic risks and establishing a national cord blood stem cell bank program. Dr. Childress is a member of the IOM. Peter B. Corr, Ph.D., is founder and general partner of Celtic Therapeutics L.L.L.P., a private equity firm focused on the development of innovative therapeutics, the development of alliances that advance solutions for dis- eases of the developing world, and global advocacy for biomedical innova- tion. Dr. Corr retired from Pfizer Inc. at the end of 2006, where he served as senior vice president for science and technology. Before that, he served as executive vice president of Pfizer Global Research and Development and president of Worldwide Development. Before joining Pfizer in 2000, Dr. Corr was president of pharmaceutical research and development at War- ner Lambert/Parke Davis (until the merger with Pfizer), and he previously served as senior vice president of discovery research at Monsanto/Searle. Dr. Corr also spent 18 years as a researcher in molecular biology and pharmacology at Washington University in St. Louis, Missouri, where he was a professor of medicine (cardiology) and a professor of pharmacology and molecular biology. Dr. Corr owns stock and retains stock options in Pfizer Inc. from his employment at the company, and he sits on the Boards of Directors of CBio, an Australian biotechnology company, and Cibus, an agricultural biotechnology firm headquartered in San Diego, California. His research has been published in more than 160 scientific manuscripts. Dr. Corr serves on the Board of Governors of the New York Academy of Sciences, the Board of Regents of Georgetown University, and several other nonprofit and for-profit boards. He is also a member of the Institute of Medicineâs Forum on Drug Discovery, Development, and Translation. Todd Dorman, M.D., is associate dean and director of continuing medical education as well as a professor of anesthesiology and critical care medicine at the Johns Hopkins Medical Center (JHMC). Among other posts, he is the vice chair for critical care services. Dr. Dormanâs research interests include informatics applications in the intensive care unit (ICU), such as remote monitoring of critically ill patients; leadership strategies in the ICU; the cre- ation of a culture of safety; and the application of pharmacokinetic models to drug administration in critically ill patients. He has participated in the development and application of conflict of interest policies in a number of areas within and outside JHMC, including continuing medical education, medical center relationships with commercial entities, guidelines develop-
396 CONFLICT OF INTEREST ment, and scientific journal publication. He served as a co-principal inves- tigator on the project on the effectiveness of continuing medical education funded by the Agency for Healthcare Research and Quality. Dr. Dorman is president of the American Society of Anesthesiologists and vice president of the Society for Academic CME. Deborah Grady, M.D., M.P.H., is a professor of medicine, associate dean for clinical and translational research, and director of the Womenâs Health Clinical Research Center at the University of California, San Francisco (UCSF). She is a general internist who provides clinical care for adult women and is an expert on the risks and benefits of postmenopausal hor- mone therapy. Dr. Grady has received funding for independent research from the National Institutes of Health (NIH) and nonprofit and commercial sources and has led several large, long-term clinical studies. In addition to six current NIH-funded activities, she is currently investigator for one study of the treatment for metastatic breast cancer and two studies of treatments for menopause symptoms that are supported by Bionovo through awards to UCSF under university policies that provide for university ownership of the research data, information, and reports resulting from the research and for independence in the publication of research findings. University policies also state that faculty conducting research that is privately sponsored shall not receive honoraria, consulting fees, or other compensation from the sponsor or serve on any board or in other decision-making capacity for the sponsor during the course of the research. She is one of the directors of the UCSF Clinical and Translational Science Institute and coedited Designing Clinical Research, a textbook on clinical research methods. Dr. Grady is also a member of the Executive Committee of the San Francisco Coordinat- ing Center, which provides coordination services for multicenter studies in womenâs health, aging, and related areas. She has participated in the devel- opment of practice guidelines and evidence reviews in a number of areas of womenâs health and served on the Institute of Medicine committee that assessed the need for clinical trials of testosterone replacement therapy. Timothy S. Jost, J.D., is the Robert L. Willett Family Professor of Law at the Washington and Lee University School of Law. He is a coauthor of the widely used teaching book, Health Law, now in its sixth edition, and is the author of Readings in Comparative Health Law and Bioethics, Health Care at Risk: A Critique of the Consumer-Driven Movement, and Disentitlement, and the editor of Health Care Coverage Determinations: An International Comparative Study and Regulation of the Healthcare Professions. He has written numerous articles and book chapters on health care regulation and comparative health law and policy. Professor Jost was a member of the Institute of Medicine (IOM) committee that assessed and recommended
APPENDIX G 397 improvements in the U.S. system for protecting human research participants and was a scholar in residence at the IOM in 2005. Robert P. Kelch, M.D., is executive vice president for medical affairs at the University of Michigan, Ann Arbor, and chief executive officer of the University of Michigan Health System. He oversees the University of Michi- gan Hospitals and Health Centers and the University of Michigan Medical School, including their policies governing conflicts of interest in research, education, patient care, and other areas. Earlier, Dr. Kelch served as vice president of the University of Iowa Health System and was previously chair of the Department of Pediatrics at the University of Michigan and physician-in-chief of C. S. Mott Childrenâs Hospital. He has been president of the Society for Pediatric Research and chairman of the American Board of Pediatrics. Dr. Kelch has also served on the American Association of Medical Colleges task force on conflicts of interest as well as numerous other association committees. He is a member of the U.S. Department of Veterans Affairs National Research Advisory Council. His research has focused on pediatric endocrinology. Dr. Kelch is a member of the Institute of Medicine. Robert M. Krughoff, J.D., is founder and president of Consumersâ CHECK- BOOK/Center for the Study of Services, an independent, nonprofit consumer organization founded in 1974. The organization publishes local versions of Consumersâ CHECKBOOK magazine in seven major metropolitan areas (Boston, Massachusetts; Chicago, Illinois; Minneapolis/St. Paul, Minnesota; Philadelphia, Pennsylvania; San Francisco/Oakland/San Jose, California; Seattle/Tacoma, Washington; and Washington, D.C.). The magazine evalu- ates local service firms such as hospitals, auto repair shops, and banks. The center also has developed the Consumersâ Guide to Hospitals, Guide to Health Plans for Federal Employees, and other materials and services for consumers. Before founding the Center for the Study of Services, Mr. Krughoff served in the U.S. Department of Health, Education, and Welfare (now the U.S. Department of Health and Human Services) as director of the Office of Research and Evaluation Planning and as special assistant to the Assistant Secretary for Planning and Evaluation. He currently serves on the board of directors of the Consumer Federation of America (1984 to the present) and has served on the board of directors of Consumers Union, publisher of Consumer Reports magazine. He chairs the Technology Assess- ment Advisory Committee for the ECRI Institute. Mr. Krughoff is a member of the New York Bar and District of Columbia Bar. George Loewenstein, Ph.D., is the Herbert A. Simon Professor of Econom- ics and Psychology in the Department of Social and Decision Sciences at
398 CONFLICT OF INTEREST Carnegie Mellon University. Previously, he was on the faculty of the Uni- versity of Chicagoâs Graduate School of Business. His research focuses on behavioral economics and neuroeconomics. He is a fellow of the American Psychological Association and was a member of the National Research Council Committee on a Research Agenda for the Social Psychology of Aging. Dr. Loewenstein is coeditor of Conflicts of Interest: Challenges and Solutions in Business, Law, Medicine, and Public Policy as well as the au- thor of numerous articles, book chapters, and other publications on topics in economics, psychology, and public policy. Joel Perlmutter, M.D., is Elliot Stein Family Professor of Neurology and Professor of Radiology, Physical Therapy and Occupational Therapy at Washington University in St. Louis, Missouri, where he is head of move- ment disorders. He is director of the American Parkinson Disease Asso- ciation Advanced Research Center for Parkinson Disease, the Huntington Disease Center of Excellence, and the NeuroClinical Research Unit and the Brain, Behavior, and Performance Unit at Washington University. Dr. Perlmutter is a member of the American Academy of Neurology, the Parkin- sonâs Study Group, the Huntingtonâs Study Group, and the Dystonia Study Group and is a fellow of the American Neurological Association. One of Dr. Perlmutterâs main research interests is brain imaging investigation of the pathophysiology of Parkinsonâs disease and related movement disorders. He has participated in the development of conflict of interest policies for clinical research, patient care, and education. Neil R. Powe, M.D., M.P.H., M.B.A., is University Distinguished Service Professor of Medicine and Epidemiology at the Johns Hopkins School of Medicine and Bloomberg School of Public Health and director of the Welch Center for Prevention, Epidemiology, and Clinical Research, a multidisci- plinary clinical research and training center at Johns Hopkins. Dr. Powe also directs the Clinical Research Scholars Program and the Predoctoral Clinical Research Training Program. He is a member of the Institute of Medicine. He is also a member of the Agency for Healthcare Research and Quality National Advisory Committee, the Board of Trustees of the Foundation for Anaemia Research (an independent medical research charity), and the Secretaryâs Advisory Committee on Human Research Protections (U.S. Department of Health and Human Services). Dr. Poweâs research bridges medicine and public health and includes prevention and screening, clinical epidemiology, patient outcomes research, quality of care, technology assess- ment, and cost-effectiveness analysis. He has participated in the develop- ment of clinical practice guidelines and studied their implementation.
APPENDIX G 399 Dennis F. Thompson, Ph.D., is Alfred North Whitehead Professor of Politi- cal Philosophy in the Government Department and a professor of public policy at the Kennedy School, Harvard University. He was founding direc- tor of the universitywide Edmond J. Safra Foundation Center for Ethics from 1986 to 2007 and served as associate provost and later as the senior adviser to the president of the university until 2004. His books include Restoring Responsibility: Ethics in Government, Business and Healthcare; Political Ethics and Public Office; and Ethics in Congress: From Individual to Institutional Corruption. He is also the author (jointly with Amy Gut- mann) of Why Deliberative Democracy? and Democracy & Disagreement. Dr. Thompson, a political scientist, has served as a consultant to the Joint Ethics Committee of the South African Parliament, the American Medical Association, the U.S. Senate Select Committee on Ethics, the U.S. Office of Personnel Management, and the U.S. Department of Health and Human Services. David A. Williams, M.D., is chief of hematology/oncology and director of translational research at Childrenâs Hospital Boston. He is also Leland Fikes Professor of Pediatrics, Harvard Medical School. He was previously direc- tor of the Division of Experimental Hematology and associate chair for translational research at Cincinnati Childrenâs Hospital Medical Center. He served as the inaugural director of the Herman B. Wells Center for Pediatric Research at the Indiana University School of Medicine and was an investi- gator of the Howard Hughes Medical Institute for 16 years. Dr. Williamâs research focuses on the study of blood stem cell biology, blood formation, leukemia, and the treatment of genetic blood disorders using gene therapy. He has received several patents, including, among others, three on methods to increase the efficiency of gene transfer for genetic therapies. Dr. Williams is actively involved in gene therapy trials for congenital immunodeficiencies and pediatric cancer. His policy interests include physician-scientist training and the development of more effective approaches to translational research. He is a member of the Institute of Medicine. Study Staff Marilyn J. Field, Ph.D., study director, is a senior program officer at the Institute of Medicine (IOM). Her recent projects at the IOM have exam- ined the safety of pediatric medical devices and clinical research involv- ing children. Among earlier projects, she has directed three studies of the development and use of clinical practice guidelines, two studies of pallia- tive and end-of-life care, and congressionally requested studies of employ- ment-based health insurance and Medicare coverage of preventive services. Past positions include associate director of the Physician Payment Review
400 CONFLICT OF INTEREST Commission, executive director for Health Benefits Management at the Blue Cross and Blue Shield Association, and assistant professor of public administration at the Maxwell School of Citizenship and Public Affairs, Syracuse University. Her doctorate in political science is from the University of Michigan, Ann Arbor. Franklin Branch is a research associate for the Board on Health Sciences Policy. Before joining the Institute of Medicine, he worked for the Adoles- cent Health Research Group at Johns Hopkins University and at the Ameri- can Association of People with Disabilities. Mr. Branch graduated with a B.A. in psychology from the University of Michigan, Ann Arbor. Robin E. Parsell is a senior program assistant for the Board on Health Sci- ences Policy. Before joining the Institute of Medicine, she gained 3 years of community-based preparatory research experience with special popula- tions at the Johns Hopkins University Center on Aging and Health and other applied research experience at the Pennsylvania State University. Ms. Parsell graduated with a B.S. in biology (focus in molecular genetics and biochemistry) and a Certificate in Gerontology from the University of Alabama at Birmingham.