Appendix C
Biographical Sketches of the Members and Staff of the Committee on the Use of Third Party Toxicity Research with Human Research Participants

Cochair, James F. Childress (IOM), B.A., Guilford College; B.D., Yale Divinity School; M.A. and Ph.D., Yale University, is the John Allen Hollingsworth Professor of Ethics and Professor of Medical Education at the University of Virginia, where he teaches in the Department of Religious Studies and is Director of the Institute for Practical Ethics and Public Life. He served as Chair of the Department of Religious Studies, 1972-1975 and 1986-1994, as Principal of the University of Virginia’s Monroe Hill College from 1988 to 1991, and as co-director of the Virginia Health Policy Center 1991-1999. In 1990 he was named Professor of the Year in the state of Virginia by the Council for the Advancement and Support of Education. He is the author of numerous articles and several books in biomedical ethics, including Principles of Biomedical Ethics (with Tom L. Beauchamp); Priorities in Biomedical Ethics; Who Should Decide? Paternalism in Health Care; and Practical Reasoning in Bioethics, along with articles and books in other areas of ethics. Childress was Vice Chair of the national Task Force on Organ Transplantation, and he has also served on the Board of Directors of the United Network for Organ Sharing (UNOS), the UNOS Ethics Committee, the Recombinant DNA Advisory Committee, the Human Gene Therapy Subcommittee, the Biomedical Ethics Advisory Committee, and several Data and Safety Monitoring Boards for National Institutes of Health Clinical Trials. He was a member of the presidential-appointed National Bioethics Advisory Commission 1996-2001. Childress is a fellow of the American Academy of Arts and Sciences and, in 1998, was elected to membership in the Institute of Medicine of the National Academy of Sciences. He is also a fellow of the Hastings Center. He has



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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues Appendix C Biographical Sketches of the Members and Staff of the Committee on the Use of Third Party Toxicity Research with Human Research Participants Cochair, James F. Childress (IOM), B.A., Guilford College; B.D., Yale Divinity School; M.A. and Ph.D., Yale University, is the John Allen Hollingsworth Professor of Ethics and Professor of Medical Education at the University of Virginia, where he teaches in the Department of Religious Studies and is Director of the Institute for Practical Ethics and Public Life. He served as Chair of the Department of Religious Studies, 1972-1975 and 1986-1994, as Principal of the University of Virginia’s Monroe Hill College from 1988 to 1991, and as co-director of the Virginia Health Policy Center 1991-1999. In 1990 he was named Professor of the Year in the state of Virginia by the Council for the Advancement and Support of Education. He is the author of numerous articles and several books in biomedical ethics, including Principles of Biomedical Ethics (with Tom L. Beauchamp); Priorities in Biomedical Ethics; Who Should Decide? Paternalism in Health Care; and Practical Reasoning in Bioethics, along with articles and books in other areas of ethics. Childress was Vice Chair of the national Task Force on Organ Transplantation, and he has also served on the Board of Directors of the United Network for Organ Sharing (UNOS), the UNOS Ethics Committee, the Recombinant DNA Advisory Committee, the Human Gene Therapy Subcommittee, the Biomedical Ethics Advisory Committee, and several Data and Safety Monitoring Boards for National Institutes of Health Clinical Trials. He was a member of the presidential-appointed National Bioethics Advisory Commission 1996-2001. Childress is a fellow of the American Academy of Arts and Sciences and, in 1998, was elected to membership in the Institute of Medicine of the National Academy of Sciences. He is also a fellow of the Hastings Center. He has

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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues been the Joseph P. Kennedy, Sr., Professor of Christian Ethics at the Kennedy Institute of Ethics at Georgetown University (1975-1979) and a Visiting Professor at the University of Chicago Divinity School and Princeton University. Cochair, Michael R. Taylor, B.A. (Political Science), Davidson College; J.D., University of Virginia, is Senior Fellow and Director, Risk, Resource, and Environmental Management Division, Resources for the Future (RFF); and a member of the Board of Trustees of Resolve, Inc., a nonprofit environmental and public health mediation and dispute resolution organization. At RFF, Taylor leads a research program on the policy and institutional issues affecting the success of the global food and agricultural system in areas such as food security in developing countries, food safety as a global concern, and the natural resource and environmental sustainability of agriculture. Publications include Redesigning Food Safety: Using Risk Analysis to Build a Better Food Safety System (2001) (co-author). Prior to coming to RFF, Taylor served in government, practiced law in Washington, D.C., and worked in private industry. He was Administrator of the Department of Agriculture’s Food Safety and Inspection Service; Deputy Commissioner for Policy at the Food and Drug Administration (FDA), and an FDA staff lawyer and Executive Assistant to the FDA Commissioner. He practiced food and drug law and was a partner in the law firm of King and Spalding and was Vice President for Public Policy at Monsanto Company. He is currently a member of the National Academies Committee on Implications of Dioxin in the Food Supply, and he has served on the Subcommittee on Defining Science-Based Concerns Associated with Products of Animal Biotechnology; the Food Forum; and the Committee on Scientific and Regulatory Issues Underlying Pesticide Use Patterns and Agricultural Innovation. James V. Bruckner, B.S. (Pharmacy), University of Texas, Austin; M.S. (Toxicology), University of Texas at Austin; Ph.D. (Toxicology), University of Michigan, Ann Arbor, is Professor of Pharmacology and Toxicology, Department of Pharmaceutical and Biomedical Sciences, College of Pharmacy, University of Georgia. He was director of the University of Georgia’s Interdisciplinary Graduate Program in Toxicology for 15 years. He was recently a member of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel for Evaluation of Exposure and Hazards to Children from Contact with Chromated Copper Arsenate-Treated Wood Structures, Office of Pesticide Programs, EPA; peer reviewer of applications for Hazardous Substances Research Center Grants, National Center for Environmental Research and Quality Assurance, Office of Research and Development, EPA; peer reviewer of research con-

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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues ducted by the Experimental Toxicology Division, National Health and Environmental Effects Research Laboratory, EPA; peer reviewer for EPA of state-of-the-science documents including one discussing Incorporating Children’s Toxicokinetic Principles into Human Health Risk Assessments; and member of an expert panel on Assessing Risks of Environmental Agents to Children, Office of Research and Development, EPA. He has served on the editorial boards of the Journal of Toxicology and Environmental Health, Chemosphere, Toxicology, and Toxicology and Applied Pharmacology. Bruckner’s research focuses on the toxicology and toxicokinetics of solvent drugs and solvent interactions at low exposure levels and pharmacokinetic bases for susceptibility of children to insecticides and other chemicals. The relevance of experimental designs to “real life” chemical exposures is of particular interest. He has published more than 200 journal articles, book chapters, and abstracts. He has served on many National Academies Committees, including the Board on Environmental Studies and Toxicology Subcommittee on Acute Exposure Guideline Levels, the Committee on Health and Safety Consequences of Child Labor, the Committee on Pesticides in the Diets of Infants and Children, the Subcommittee on Dibromochloropane, and the Committee on Safe Drinking Water. Alicia Carriquiry, B.S. (Ag Engineering), Universidad del Uruguay; M.Sc. (Animal Genetics), University of Illinois; M.Sc. (Statistics), Iowa State University; Ph.D. (Statistics and Animal Science), Iowa State University, is Associate Provost and Professor of Statistics, Iowa State University. She was a Visiting Professor at the Institute for Statistics and Decision Sciences, Duke University, and at the Department of Statistics, Pontifical Catholic University of Chile. She also serves as a Consultant to Mathematical Policy Research, ABT Associates, Kemin Food Industries, and Law and Economics Consulting Group. She is an Elected Member of the International Statistical Institute and a Fellow of the American Statistical Association. She is Past President of the International Society for Bayesian Analysis and serves on the Executive Committee of the Institute of Mathematical Statistics. She has been a Trustee of the National Institute of Statistical Sciences since 1997, and currently serves on its Executive Committee. She also is a member of the Board of the Plant Sciences Institute at Iowa State University. Carriquiry is Editor of Statistical Sciences and serves on the editorial boards of several Latin American journals of statistics and mathematics. She has published over 50 refereed articles and technical reports and has co-edited four books. Her research interest is in the development of Bayesian methods and on the application of those methods to problems in public health, human nutrition, genetics, and economics. She also has worked in the area of stochastic volatility and other non-

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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues linear models for time-dependent data. She has served on two National Academies committees: the Subcommittee on Interpretation and Uses of Dietary Reference Intakes and the Committee on Evaluation of USDA’s Methodology for Estimating Eligibility and Participation for the WIC Program. She has been a co-author of four National Academy of Sciences reports and is a member of the Federal Steering Committee Future Directions for the CSFII/NHANES Diet/Nutrition Survey: What We Eat in America. Ellen Wright Clayton, B.S., Duke University; M.S., Stanford University; J.D., Yale University; M.D., Harvard University, is one of the preeminent scholars in the field of law and genetics. She joined the Vanderbilt faculty in 1988 and holds appointments in both the Medical School and Law School. She is the Director of the Genetics and Health Policy Center at Vanderbilt and holds the Rosalind E. Franklin Chair in Genetics and Health Policy there. She has published two books and has authored numerous chapters and articles in medical journals, interdisciplinary journals, and law journals on the intersection of law, medicine, and public health. Clayton has collaborated with faculty in the Law School, Medical School, and Sociology Department in producing interdisciplinary research. She has been an active participant in policy debates advising the National Human Genome Research Institute as well as numerous national and international bodies concerned with the ethical conduct of research involving humans for many years. She is currently the Co-chair of the Ethical, Legal, and Social Issues Committee of the International HapMap Project as well as its liaison to Japan. In addition to teaching at the Law School and Medical School, Clayton is a practicing pediatrician at the Vanderbilt Medical Center. She currently serves as a member of the Institute of Medicine’s Board on Health Sciences Policy. John Doull, B.S. (Chemistry), Montana State University; Ph.D. (Pharmacology), University of Chicago; M.D., University of Chicago, is Professor Emeritus of Pharmacology and Toxicology and Therapeutics, Department of Pharmacology, Toxicology and Therapeutics, University of Kansas Medical Center. Prior to that, he was Assistant Director of the University of Chicago Toxicity Laboratory and Associate Professor in the Department of Pharmacology at the University of Chicago. He served on the Toxicology Study Section of the National Institutes of Health and the Council of the National Institute of Environmental Health Sciences. He is past president of the Society of Toxicology and the American Board of Toxicology, has chaired the Threshold Limit Value Committee of the American Conference of Governmental Industrial Hygienists, served on the Expert Panels of the International Life Sciences Institute, the Federal

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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues Emergency Management Agency, and DISCUS, and was a member of the Presidential Clean Air Commission. He has served on the scientific advisory panels of EPA, the National Institute for Occupational Safety and Health, and others, and he consults with many governmental, state, industrial, and private organizations. He has received numerous awards from the Society of Toxicology, Robert Wood Johnson Medical School, International Society for Regulatory Toxicology and Pharmacology, Department of the Army, University of Chicago, American Conference of Governmental Industrial Hygienists, and American College of Toxicology. Doull currently serves on the National Academies Board on Environmental Studies and Toxicology and the Subcommittee on Acute Exposure Guidelines Levels. He has also served on the Committee on Risk Assessment of Exposure to Radon in Drinking Water (Chair), the Committee on Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces, the Committee on Risk Assessment of Hazardous Air Pollutants, the Committee on Risk Assessment Methodology, the Subcommittee on Guidelines for Developing Community Emergency Exposure Levels for Hazardous Substances (Chair), the Committee on Toxicology (Chair), the Advisory Committee on the CDC Study of the Health of Vietnam Veterans, the Committee on Methods for In Vivo Toxicity Testing of Complex Mixtures from the Environment (Chair), the Board on Toxicology and Environmental Health Hazards, the Committee on Identification of Toxic and Potentially Toxic Chemicals for Consideration by the National Toxicology Program, and the Committee on Toxicity Data Elements. Henry T. (Hank) Greely, A.B., Stanford University; J.D., Yale Law School, is the Director of the Stanford Center for Law and the Bioscience, the C. Wendell and Edith M. Carlsmith Professor of Law, and Professor, by courtesy, of Genetics at Stanford University. He chairs the steering committee of the Stanford University Center for Biomedical Ethics; co-directs the Stanford Program in Law, Science, and Technology; and co-directs the Stanford program on Genomics, Ethics, and Society. He specializes in legal and social issues arising from advances in the biosciences and in health law and policy and has written on issues concerning genetic testing, human cloning, the ethics of human genetics research, and policy issues in the health care financing system. Greely has been a member of the Stanford faculty since 1985 and served as Chair of the Stanford Faculty Senate (2002-2003). He serves on the California Advisory Committee on Human Cloning; the Scientific Advisory Committee and the Ethical Advisory Committee for the Veteran’s Affairs Department’s Program on Genetic Tissue Banking in Veteran’s Affairs Clinical Research; and the North American Committee of the Human Genome Diversity Project, whose ethics subcommittee he chairs. He served as a law clerk for Judge John Minor

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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues Wisdom on the United States Court of Appeals and for Justice Potter Stewart of the United States Supreme Court. Siobán D. Harlow, B.A. (Health Arts and Sciences), University of California, Berkeley; Ph.D. (Epidemiology), Johns Hopkins School of Hygiene and Public Health, is Associate Professor, Epidemiology, Department of Epidemiology, School of Public Health, University of Michigan and Associate Director of the International Institute, University of Michigan. She also is Director of the Advanced Studies Center and Faculty Associate, Center for Research on Ethnicity, Culture, and Health, School of Public Health, both at the University of Michigan. In addition she is a member of the Scientific and Technical Advisory Group of the Department of Reproductive Health and Research at the World Health Organization. She was the convener of the international, interdisciplinary workshop on “Risk Assessment in the Context of Trade Disputes” and is editor of the forthcoming collection of papers to appear in Risk Assessment: An International Journal. She has served on numerous grant review panels for the National Institute of Environmental and Health Sciences, the National Institute for Occupational Safety and Health, the National Institute of Child Health and Human Development, and the Workplace Safety and Insurance Board of Ontario. Her research focuses on reproductive, prenatal, and occupational epidemiology in developing countries. She has helped develop a generation of reproductive epidemiologists in Mexico who focus on the adverse effects of environmental and occupational exposures. In collaboration with El Colegio de Sonora, she co-founded the Programa de Formación de Investigadores en Salud Reproductiva to foster the development of human resources in reproductive health research in the U.S.-border region of Mexico with support from the Fogarty International Center. In collaboration with her Mexican colleagues, she has conducted some of the first epidemiologic studies of the health status of the maquiladora workers, evaluating the interlinkages between export-led development strategies and health. Her memberships include Phi Beta Kappa, Delta Omega, the North American Menopause Society, and the Society for Epidemiologic Research. Lester B. Lave (IOM), B.A. (Economics), Reed College; Ph.D. (Economics) Harvard University, is the Harry B. and James H. Higgins University Professor of Economics and Finance; Professor, Engineering and Public Policy, the H. John Heinz III School of Public Policy and Management; Director, Green Design Initiative; and Co-director, Carnegie Mellon University Electricity Industry Center, Carnegie Mellon University. His work has focused on environmental quality, risk perception and communication, and risk analysis and risk management—devising tools that quan-

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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues tify health, safety, and environmental risks and then investigating ways to manage these risks more efficiently and effectively. He has examined the effects of air pollution on human health and developed air pollution policy that is both efficient and effective and evaluated the information content of tests for determining whether chemicals are toxic and the value of tests in reproductive toxicology. He is the recipient of the Distinguished Achievement Award of the Society for Risk Analysis. Lave has served on committees of the American Medical Association and the American Academy for the Advancement of Science, participating as Acting Chairman of the Assembly of Social and Behavioral Sciences. He has participated on many grant review panels of the National Institutes of Health, the National Science Foundation, and EPA. He has served on numerous Academy committees, including the Committee on Risk-Based Analysis for Flood Damage Reduction, the Committee on Industrial Competitiveness and Environmental Protection, the Committee on the Medical Use Program of the Nuclear Regulatory Commission, the Board on Natural Disasters, the Board on Health Promotion and Disease Prevention, the U.S. National Committee for the Decade for Natural Disaster Reduction, the Committee on Dietary Guidelines Implementation, the Water Science and Technology Board, the Committee on Dam Safety, and the Energy Engineering Board. Bernard Lo (IOM), A.B. (Physics), Harvard College; M.A. (Comparative Literature), University of Sussex; A.M. (History of Science), Harvard University; M.D., Stanford University, is Professor of Medicine and Director, Program in Medical Ethics, University of California, San Francisco. He directs the Greenwall Faculty Scholars in Bioethics Program and is a member of the Recombinant DNA Advisory Committee at the National Institutes of Health (NIH) and the Data Safety Monitoring Board for NIH-sponsored clinical trials in diabetes. Lo formerly was a member of the National Bioethics Advisory Commission and the Data Safety Monitoring Board for the AIDS Clinical Trials Group at NIH. He also directed the national coordinating office for the Robert Wood Johnson Foundation Initiative to Strengthen the Patient-Provider Relationship in a Changing Health Care Environment, and he chaired the End-of-Life Committee convened by the American College of Physicians. He is a former member of the Board of Directors of the American Society of Law, Medicine, and Ethics and the American Society for Bioethics and Humanities. He has written more than 100 articles in peer-reviewed medical journals on issues such as decisions about life-sustaining interventions, decision making for incompetent patients, physician-assisted suicide, ethical issues regarding HIV infection, and the doctor-patient relationship in managed care. He is the author of Resolving Ethical Dilemmas: A Guide for Clinicians,

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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues a comprehensive analysis of ethical dilemmas in adult medicine. He also is a practicing general internist who teaches clinical medicine to residents and medical students. He is a member of the Institute of Medicine (IOM) and serves on the IOM Council and on the Report Review Committee of the National Research Council. He formerly was a member of the IOM Board on Health Sciences Policy, which he chaired from 1999 to 2002. He also chaired the Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection. Thomas A. Louis, B.A. (honors in Mathematics), Dartmouth College; Ph.D. (Mathematical Statistics), Columbia University, is Professor, Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health. He was Assistant Professor, Department of Mathematics, Boston University (1973-1978); Associate Professor, Department of Biostatistics, Harvard School of Public Health (1978-1987); Professor, Division of Biostatistics, University of Minnesota School of Public Health (1987-2000, Division Head 1987-1999); Senior Statistical Scientist, RAND (2000-2002), and Visiting Scholar, Committee on National Statistics (CNSTAT), National Academy of Sciences (1999). He is an elected member of the International Statistical Institute and a Fellow of the American Statistical Association and of the American Association for the Advancement of Science. He served as President of the Eastern North American Region of the International Biometrics Society and is Chair-elect of the American Statistical Association’s Section on Bayesian Statistical Science. From 2001 through 2003, he was coordinating editor of the Journal of the American Statistical Association. He serves on the Health Review Committee of the Health Effects Institute. Louis has published more than 150 articles, books, and monographs. His research interests include risk assessment; environmental, health, and public policy and the development of related statistical approaches. He concentrates on Bayesian modeling, including small area estimation, the analysis of observational studies, and research synthesis. Current applications include assessing the health effects of airborne particulate matter, assessing the cardio-pulmonary consequences of AIDS therapies, and reproductive health and the evaluation of teacher effectiveness. His Academy service includes membership on CNSTAT and on the Board of the Institute of Medicine’s (IOM’s) Medical Follow-up Agency. He served on the IOM Panel to Assess the Health Consequences of Service in the Persian Gulf War and on the CNSTAT Panel on Estimates of Poverty for Small Geographic Areas, and he chaired the CNSTAT Panel on Formula Allocation of Federal and State Program Funds. Joseph V. Rodricks, B.S. (Chemistry), Massachusetts Institute of Technology; M.S. (Organic Chemistry), University of Maryland; Ph.D. (Biochem-

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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues istry) University of Maryland, is Founding Principal, Environ International Corporation (1982). He is a Visiting Professor at the Johns Hopkins University School of Public Health. He is an internationally recognized expert in the field of toxicology and risk analysis and in their uses in regulation and in the evaluation of toxic tort and product liability cases. He has testified before Congress on risk assessment related to pesticides and food safety. Since 1980, he has consulted for hundreds of manufacturers, for government agencies and for the World Health Organization. He currently serves on Academy committees on Dietary Reference Intakes for Nutrients and Gulf War and Health. He has previously served on 16 Academy committees, including the Committee on Toxicological and Performance Aspects of Oxygenated Motor Vehicle Fuels, the Committee on Risk Assessment of Hazardous Air Pollutants, the Committee on Neurotoxicology and Models for Assessing Risk; the Committee on Human Health Risk Assessment of Using Antibiotics in Animal Feed, the Committee on Public Health Risk Assessment of Poultry Inspection, the Board on Toxicology and Environmental Health Hazards, the Subcommittee to Evaluate Effects of Short-Term Exposures to Drinking Water Contaminants (Chair), and the Committee on Institutional Means for Assessment of Risks to Public Health. He has written more than 100 publications on toxicology and risk analysis and has lectured nationally and internationally on these topics. Recent articles and book chapters include “Some Attributes of Risk Influencing Decision-Making by Public Health and Regulatory Officials” and “Toxicological Risk Assessment in the Courtroom: Are Available Methodologies Suitable for Evaluating Toxic Tort and Product Liability Claims?” Rodricks was formerly Deputy Associate Commissioner, Health Affairs, and Toxicologist, Food and Drug Administration. He is a Diplomat, American Board of Toxicology. His experience includes chemical products and contaminants in foods, food ingredients, air, water, hazardous wastes, the workplace, consumer products, and medical devices and pharmaceutical products. He is the author of Calculated Risks, a nontechnical introduction to toxicology and risk analysis, now in its sixth printing, for which he won an award from the American Medical Writers Association. Christopher H. Schroeder, B.A., Princeton University; M.Div., Yale University; J.D., University of California, Berkeley, is Charles S. Murphy Professor of Law and Public Policy Studies and Director of the Program in Public Law, Duke University Law School. He has served as Acting Assistant Attorney General in the Office of Legal Counsel at the Department of Justice. He also has served as Chief Counsel to the Senate Judiciary Committee. His areas of research and scholarship include environmental and administrative law, democratic theory, legislative institutions, and sepa-

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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues ration of powers. He has taught environmental law; government, business and public policy; environmental litigation; toxic substances regulation; and philosophy of environmental protection. He has written on the philosophical foundations of risk regulation and liability, the regulation of toxic substances, the performance of American environmental policy, and a variety of topics in public law and theory. He co-authored a leading environmental law casebook, Environmental Regulation: Law, Science, and Public Policy. He is the editor of forthcoming Resources for the Future book evaluating the performance of EPA. He has written extensively on environmental and administrative law, risk regulation and liability, and regulation of toxic substances. Robert Temple, B.A., Magna Cum Laude, Harvard College; M.D., New York University School of Medicine. At New York University, he was elected to Alpha Omega Alpha, and he completed an internship and residency in internal medicine at the Columbia Presbyterian Medical Center in 1969. Board certified in internal medicine and clinical pharmacology, Temple is Director of the Office of Medical Policy of the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research and Acting Director of the Office of Drug Evaluation 1 (ODE-1). ODE-1 is responsible for the regulation of cardio-renal, oncologic, and neuropharmacologic/psychopharmacologic drug products. The Office of Medical Policy is responsible for regulation of promotion through the Division of Drug Marketing, Advertising, and Communication and for assessing quality of clinical trials and helping to assure participant protection through the Division of Scientific Investigations. Temple has a longstanding interest in the design and conduct of clinical trials and has written extensively on this subject, especially on choice of control group in clinical trials, evaluation of active control trials, trials to evaluate dose-response, and trials using “enrichment” designs. He was Clinical Associate and then Chief Clinical Associate in the Clinical Endocrinology Branch of the National Institute of Arthritis, Metabolism, and Digestive Diseases, National Institutes of Health, from 1969 to 1972, investigating the effects of lithium on the thyroid and examining the effects of agents that disrupt microtubules on steroid secretion. He became a reviewing Medical Officer in the Division of Metabolic and Endocrine Drug Products in 1972 and became Assistant to the Director of the Bureau of Drugs in 1974. In 1976, he became the Director of the Division of Cardio-Renal Drug Products, serving in that role until 1982. From 1982 to 1988 he was Acting Director and then Director of the Office of Drug Research and Review. Among other awards, he has received FDA’s Award of Merit on six occasions, three Commissioner’s Special Citations, the Public Health Service Superior Service award, the Department of Health and Human Services

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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues Distinguished Service Award, the Secretary’s Special Citation, and the Drug Information Association Outstanding Service Award. He received the American Society for Clinical Pharmacology and Therapeutics’ Rawls-Palmer Progress in Medicine Lecture and Award in 2001. He also received the National Organization for Rare Disorders Public Health Leadership Award in 2001. In 2002, he received the Food and Drug Law Institute’s Distinguished Service and Leadership Award. He is on the editorial board of the journal Clinical Pharmacology and Therapeutics. He was on the Board of Directors of the Society for Clinical Trials from 1983 to 1987 and was President of the Society in 1987. He is an honorary Fellow of the American College of Clinical Pharmacology. LIAISON David Korn (IOM), B.A. Harvard College; M.D., Harvard Medical School, is Senior Vice President for Biomedical and Health Sciences Research, Association of American Medical Colleges. He is a former Carl and Elizabeth Naumann Professor, Dean of Stanford University’s School of Medicine, and Vice President of the University, as well as former Department of Pathology Professor and Chairman and Physician-in-Chief, Pathology, at Stanford University Hospital. He has served as the chair of the National Cancer Advisory Board (presidential appointment) and also the Food and Drug Administration’s Science Board’s Subcommittee to Review the Intramural Research Program. He was a member of the President’s Committee of Advisers on Science and Technology’s Panel on Health Care Reform and serves on the Department of Veterans Affairs National Research Advisory Council. He is a fellow and member of the American Association for the Advancement of Science Council, past President of the American Society of Investigative Pathology, former President of the Association of Pathology Chairmen, honorary Fellow of the American Society of Clinical Pathologists, and Fellow of the College of American Pathologists. He has held editorial positions on Human Pathology, American Journal of Pathology, and the Journal of Biological Chemistry. He is a member of the Institute of Medicine and the National Academies Science, Technology, and Law Panel. STAFF Anne-Marie Mazza, B.A., Economics; M.A., History and Public Policy; Ph.D., Public Policy, the George Washington University, joined the National Academies in 1995 and has served as Senior Program Officer with both the Committee on Science, Engineering, and Public Policy and the Government-University-Industry Research Roundtable. In 1999 she was

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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues named the first director of the Science, Technology, and Law Program. Between October 1999 and October 2000, she divided her time between the Science, Technology, and Law Program and the White House Office of Science and Technology Policy, where she served as a Senior Policy Analyst. Michelle C. Catlin, M.Sc., Pharmacology and Toxicology, Queen’s University, Canada; Ph.D., Environmental Health-Toxicology Program, University of Washington, also is Senior Program Officer for the Institute of Medicine (IOM) Board on Health Promotion and Disease Prevention. Before joining IOM, she served as a Program Officer with the Board on Environmental Studies and Toxicology of the National Research Council. She has worked on numerous National Academies reports, including Copper in Drinking Water, Toxicological Effects of Methylmercury, Arsenic in Drinking Water: 2001 Update, and Veterans and Agent Orange: Update 2000 and Update 2002. Kathi E. Hanna, M.S., Ph.D., is a science and health policy consultant, writer, and editor in the Washington, D.C., area specializing in biomedical research policy and bioethics. She has served in senior staff and consulting positions with the National Bioethics Advisory Commission, the Presidential Advisory Committee on Gulf War Veterans Illnesses, the congressional Office of Technology Assessment, the Howard Hughes Medical Institute, the National Institutes of Health, and the Institute of Medicine. Stacey Speer, B.S., Biomedical Engineering, University of Tennessee, joined the National Academies’ Science, Technology, and Law Program in September 2002 as the Christine Mirzayan Intern. Stacey is now the Senior Program Assistant of the Science, Technology, and Law Program. She is attending the George Washington University, pursuing a Master’s of Forensic Science. Sara Davidson Maddox, M.A., is a science and health policy writer and editor, with extensive experience in the areas of bioethics, biomedical research, and health services and quality. She was editor for the National Bioethics Advisory Commission and has participated in projects for the National Institutes of Health and the Institute of Medicine.