B
Discussion Leader and Speaker Biographies

Marc L. Berger, M.D., obtained his M.D. from Johns Hopkins University School of Medicine. He completed an internal medicine residency at NYU–Bellevue Hospital in New York and a Liver Research Fellowship at the University of Texas Health Science Center at Dallas–Southwestern Medical School. Prior to joining Merck, he was on the faculty of the University of Cincinnati School of Medicine. While at Merck, Dr. Berger has held various positions of responsibility for Phase II to Phase IV clinical trials, outcomes research studies and disease management programs. He is currently Vice President of Outcomes Research and Management (ORM) in the US Human Health Division. Dr. Berger has co-authored numerous articles in outcomes research, health economics, and health policy. Currently, he is a member of the AHRQ Centers for Education and Research on Therapeutics (CERTs) Steering Committee, the CMS Medicare Coverage Advisory Committee (MCAC), and the writing committee for the AHRQ development of a handbook for Registries for Evaluating Patient Outcomes. He also serves on advisory boards for the Health Industry Forum and the Program on the Economic Evaluation of Medical Technology (PEEMT) at the Harvard Center for Risk Analysis, as well as the editorial advisory board of the journal Value in Health. Dr. Berger is a trustee of the Occupational and Environmental Health Foundation and the Merck Childhood Asthma Network, Inc. He holds appointments as Adjunct Senior Fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania, Adjunct Professor in the Department of Health Policy and Administration at the University of North Carolina



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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary B Discussion Leader and Speaker Biographies Marc L. Berger, M.D., obtained his M.D. from Johns Hopkins University School of Medicine. He completed an internal medicine residency at NYU–Bellevue Hospital in New York and a Liver Research Fellowship at the University of Texas Health Science Center at Dallas–Southwestern Medical School. Prior to joining Merck, he was on the faculty of the University of Cincinnati School of Medicine. While at Merck, Dr. Berger has held various positions of responsibility for Phase II to Phase IV clinical trials, outcomes research studies and disease management programs. He is currently Vice President of Outcomes Research and Management (ORM) in the US Human Health Division. Dr. Berger has co-authored numerous articles in outcomes research, health economics, and health policy. Currently, he is a member of the AHRQ Centers for Education and Research on Therapeutics (CERTs) Steering Committee, the CMS Medicare Coverage Advisory Committee (MCAC), and the writing committee for the AHRQ development of a handbook for Registries for Evaluating Patient Outcomes. He also serves on advisory boards for the Health Industry Forum and the Program on the Economic Evaluation of Medical Technology (PEEMT) at the Harvard Center for Risk Analysis, as well as the editorial advisory board of the journal Value in Health. Dr. Berger is a trustee of the Occupational and Environmental Health Foundation and the Merck Childhood Asthma Network, Inc. He holds appointments as Adjunct Senior Fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania, Adjunct Professor in the Department of Health Policy and Administration at the University of North Carolina

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary at Chapel Hill School of Public Health, and Senior Scholar, Department of Health Policy, Jefferson Medical College. Joshua T. Cohen, Ph.D., is a Lecturer at the Tufts New England Medical Center Institute for Clinical Research and Health Policy Studies, in the Center for the Evaluation of Value and Risk. Dr. Cohen’s research focuses on the application of decision analytic techniques to public health risk management problems with a special emphasis on the proper characterization and analysis of uncertainty. His work covers a range of issues, including cell phone use while driving, alternative fuels for transit buses and school buses, tradeoffs between the nutritional benefits of fish and resulting exposure to mercury, and the risks associated with bovine spongiform encephalopathy in the United States. Dr. Cohen currently serves on a National Academy of Sciences committee charged with reviewing the U.S. Environmental Protection Agency (EPA)’s risk assessment of dioxin, and on the EPA’s Clean Air Science Advisory Committee that is now reviewing the Agency’s latest air quality criteria document for lead. He received both his Ph.D. in Decision Sciences and his B.A. in Applied Mathematics from Harvard University. A. Mark Fendrick, M.D., is a Professor of Internal Medicine in the School of Medicine and a Professor of Health Management and Policy in the School of Public Health at the University of Michigan. Dr. Fendrick received a bachelor’s degree in economics and chemistry from University of Pennsylvania and his medical degree from Harvard. Dr. Fendrick completed his residency in internal medicine at the University of Pennsylvania where he was a fellow in the Robert Wood Johnson Foundation Clinical Scholars Program. He currently directs the Health Services Research Core Laboratory and is co-director of the recently established Center for Value-Based Insurance Design at the University of Michigan. Dr. Fendrick’s research focuses on the clinical and economic assessment of medical interventions with special attention to how technological innovation influences clinical practice and impacts health care systems. He has authored over 200 articles and book chapters and lectures frequently on the health and cost implications of medical interventions to diverse audiences around the world. Dr. Fendrick remains clinically active in the practice of general internal medicine. He is the co-editor in chief of the American Journal of Managed Care and is an editorial board member for 3 additional peer-reviewed publications. His perspective and understanding of clinical and economic issues have fostered collaborations with numerous government agencies, health plans, professional societies, and health care companies. He serves on the Medicare Coverage Advisory Committee.

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary Timothy R. Franson, M.D., is currently Vice President of Global Regulatory Affairs for Lilly Research Laboratories and is also an Assistant Professor of Medicine at Indiana University School of Medicine. He received his undergraduate degree in Pharmacy (B.S. Pharm, honors) at Drake University, his M.D. degree (James Scholar, with honors) at the University of Illinois, and completed internal medicine training at the University of Iowa, followed by a fellowship in Infectious Diseases and Epidemiology at the Medical College of Wisconsin. Dr. Franson is Board Certified in Internal Medicine and Infectious Diseases. He was Assistant Professor of Medicine and Hospital Epidemiologist at the Medical College of Wisconsin where he was a National Institutes of Health (NIH) funded investigator and a member of the State of Wisconsin’s Governors Task Force on AIDS. He joined Eli Lilly and Company in 1986, where he has previously served as Director of Anti-Infectives; Group Medical Director, Europe (based in the United Kingdom); Executive Director of Health Economics Research and Decision Sciences, Executive Director of Regulatory Affairs responsible for North American Regulatory, Chemistry Manufacturing Control, Planning & Global Operations (safety, labeling, medical information, registration and submissions) and from 1997–2003, Vice President of Clinical Research and Regulatory Affairs-US. In 2002, Dr. Franson received the Lilly Chairman’s Ovation Award. Steven Galson, M.D., M.P.H., was named Director of the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA) in July 2005. He provides leadership for the Center’s broad national and international programs in pharmaceutical regulation. Dr. Galson began his Public Health Service (PHS) career as an epidemiological investigator at the Centers for Disease Control after completing a residency in internal medicine at the Hospitals of the Medical College of Pennsylvania. He has held senior-level positions at the Environmental Protection Agency, the Department of Energy where he was the Chief Medical Officer, and the Department of Health and Human Services. Prior to his arrival at FDA, Dr. Galson was the Director of the Office of Science Coordination and Policy, Office of Prevention, Pesticides and Toxic Substances, at the EPA. Dr. Galson joined FDA in April 2001 as the CDER Deputy Director. Dr. Galson is the recipient of numerous PHS awards, including the Outstanding Service Medal for his leadership and management of CDER while serving as Acting Center Director from November 2001 to February 2002. He is also the recipient of three Secretary of Energy Gold Awards. Dr. Galson is a board member of the National Board of Medical Examiners and a regular peer reviewer for medical journals. Dr. Galson holds a B.S. from Stony Brook University, an M.D. from Mt. Sinai School of Medicine and a M.P.H. from the Harvard School

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary of Public Health. He is Board Certified in Preventive Medicine & Public Health and Occupational Medicine. Alan M. Garber, M.D., Ph.D., is the Henry J. Kaiser Jr. Professor and a Professor of Medicine at Stanford University, where he is also Professor of Economics, Professor of Health Research and Policy, and Professor of Economics in the Graduate School of Business (courtesy). He has been director of both the university’s Center for Health Policy and the Center for Primary Care and Outcomes Research at the School of Medicine since their founding. He is also a Staff Physician at the Veterans Affairs Palo Alto Health Care System, Associate Director of the VA Center for Health Care Evaluation, and Research Associate and Director of the Health Care Program of the National Bureau of Economic Research (NBER). After graduating from Harvard College summa cum laude, Dr. Garber received his Ph.D. in economics from Harvard and an M.D. with research honors from Stanford, and completed his residency in Medicine at Brigham and Women’s Hospital. He is the recipient of numerous honors and awards, including the Young Investigator Award of the Association for Health Services Research (now AcademyHealth) and the Henry J. Kaiser Family Foundation Faculty Scholarship in General Internal Medicine. He is a member of the national Blue Cross and Blue Shield Association Medical Advisory Panel and serves as their Scientific Adviser, and a member of the American Society for Clinical Investigation, the Association of American Physicians, the Institute of Medicine of the National Academy of Sciences, and the National Advisory Council on Aging (National Institutes of Health). He is the Chair of the Medicare Coverage Advisory Committee (Centers for Medicare and Medicaid Services). Dr. Garber’s research is directed toward methods for improving health care delivery and financing, particularly for the elderly, in settings of limited resources. He has developed methods for determining the cost-effectiveness of health interventions, and he studies ways to structure financial and organizational incentives to ensure that cost-effective care is delivered. In addition, his research explores how clinical practice patterns and health care market characteristics influence technology adoption, health expenditures, and health outcomes in the United States and in other countries. Louis Garrison, Ph.D., joined the faculty in the Pharmaceutical Outcomes Research & Policy Program in the Department of Pharmacy at the University of Washington in 2004. For the previous 12 years, he worked as an economist in the pharmaceutical industry. Most recently, he was Vice President and Head of Health Economics & Strategic Pricing in Roche Pharmaceuticals, and was based in Basel, Switzerland, in 2002–2004. He oversaw the development of the economic and pricing strategies, and

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary research plans for all Roche compounds. Prior to this, he was Director of the Project HOPE Center for Health Affairs. In eight years there, Dr. Garrison worked on a wide variety of health policy issues, including studies of health care reform both in the United States and overseas. Before this, he worked at the Battelle Human Affairs Research Centers in Seattle, where he carried out studies of the adequacy of physician manpower supply and the cost-effectiveness of kidney and heart transplantation. He received a B.A. in economics from Indiana University, and a Ph.D. in economics from Stanford University. Dr. Garrison’s research interests include national and international health policy issues related to insurance, pricing, and reimbursement, as well as the economic evaluation of pharmaceuticals and diagnostics, particularly for organ transplantation, renal disease, influenza, and cancer. Lynn R. Goldman, M.D., M.P.H., a pediatrician and epidemiologist, is Professor of Environmental Health Sciences at Johns Hopkins University Bloomberg School of Public Health, as well as chair of the Program in Applied Public Health. At Hopkins, she is the co-principal investigator for PACER (the Center for the Study of Preparedness and Critical Event Response) and researches impacts of environmental exposures on children’s health. An expert in chemicals and pesticide policy, she previously served as assistant administrator at the U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances. Dr. Goldman is a fellow of the American Academy of Pediatrics. She currently is a member of the Institute of Medicine Health Sciences Policy Board and Vice Chair of the Institute of Medicine Roundtable on Environmental Health Sciences, Research and Medicine and has served on multiple expert committees for the National Academies of Sciences and the government. She received the Woodrow Wilson Award for Distinguished Government Service from the Johns Hopkins University Alumni Association and the UC Berkeley, School of Public Health Alumna of the Year Award. John D. Graham, Ph.D., was born (1956) and raised in Pittsburgh, PA, a son of an accomplished steel industry executive. He earned his B.A. (politics and economics) at Wake Forest University (1978) where he won national awards as an intercollegiate debater. He earned his M.A. degree in public policy at Duke University (1980) before serving as staff associate to Chairman Howard Raiffa’s Committee on Risk and Decision Making of the National Research Council/National Academy of Sciences. His Carnegie-Mellon University Ph.D. dissertation on automobile safety, written at the Brookings Institution, was cited in pro-airbag decisions by the U.S. Supreme Court (1983) and by Secretary of Transportation

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary Elizabeth Dole (1985). Dr. Graham joined the Harvard School of Public Health as a post-doctoral fellow in 1983 and as an assistant professor in 1985. He taught the methods of decision analysis and cost-benefit analysis to physicians and graduate students in public health. His prolific writings addressed both the analytic and institutional aspects of lifesaving policies. Dr. Graham earned tenure at Harvard in 1991 at the age of thirty-four. From 1990 to 2001 Dr. Graham founded and led the Harvard Center for Risk Analysis (HCRA). By raising over $10 million in project grants and philanthropic contributions, Dr. Graham helped support eight new faculty positions and dozens of post-doctoral and doctoral students. By 2001 HCRA had become internationally recognized for analytic contributions to environmental protection, injury prevention, and medical technology innovation. In 1995 Dr. Graham was elected President of the Society for Risk Analysis, an international membership organization of 2,400 scientists and engineers. Dr. Graham reached out to risk analysts in Europe, China, Japan and Australia as he helped organize the first World Congress on Risk Analysis (Brussels, 2000). Dr. Graham became widely known to the public and opinion leaders through his entertaining speeches about why Americans are both paranoid and neglectful of risks in their daily lives. He made several prime-time television appearances, including John Stoussel’s ABC special, “Are We Scaring Ourselves to Death?” and has spoken frequently to groups of reporters, business leaders, and government officials. He has delivered invited testimony to numerous House and Senate Committees, state and federal agencies, and the European Commission and Parliament. The late Senator Daniel Patrick Moynahan (D-NY) praised Dr. Graham as a pioneer in bringing the insights from risk analysis to federal clean-air legislation. In March 2001 President Bush nominated Dr. Graham to serve as Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget. He was confirmed by the Senate in July 2001. Located in the Executive Office of the President, this small office of 50 career policy analysts oversees the regulatory activities of the federal government. In this capacity, Dr. Graham has worked to slash the growth of regulatory costs by 70 percent while encouraging good regulations that save lives, prevent disease, and protect the environment in a cost-effective manner. Dr. Graham is currently Dean of the Frederick Pardee RAND Graduate School at the RAND Corporation in Santa Monica, California. In this role, Dr. Graham leads the nation’s largest doctoral training program in public policy analysis. He also holds a Chair in Policy Analysis which supports his research activities. Richard Hall, Ph.D., was with McCormick & Company for 38 years, retiring in 1988 as Vice-President—Science and Technology. He has served on numerous NRC and IOM Boards and Committees including the Food

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary and Nutrition Board. He is a Past President of the International Union of Food Science and Technology, a fellow of the AAAS, the Institute of Food Technologists, and a Distinguished Fellow of the Toxicology Forum. Peter Barton Hutt, LL.B., LL.M., is a senior counsel in the Washington, D.C., law firm of Covington & Burling specializing in food and drug law. He graduated from Yale College and Harvard Law School and obtained a Master of Laws degree in Food and Drug Law from NYU Law School. Mr. Hutt served as Chief Counsel for the Food and Drug Administration during 1971–1975. He is the co-author of the casebook used to teach food and drug law throughout the country, and has published more than 175 book chapters and articles on food and drug law and health policy. He teaches a full course on this subject during Winter Term at Harvard Law School and has taught the same course during Spring Term at Stanford Law School. Mr. Hutt has been a member of the Institute of Medicine since it was founded in 1971. He serves on academic, philanthropic, and venture capital advisory boards, and the boards of startup biotechnology companies. He currently serves on the Panel on the Administrative Restructuring of the National Institutes of Health, the Working Group to Review Regulatory Activities Within the Division of AIDS of the National Institute of Allergy and Infectious Diseases, and the Board of Directors of the AERAS Global TB Vaccine Foundation. In April 2005, Mr. Hutt was presented the FDA Distinguished Alumni Award by FDA Commissioner Crawford. In May 2005, he was given the Lifetime Achievement Award by the Foundation for Biomedical Research, for research advocacy. Sheila Jasanoff, J.D., Ph.D., is Pforzheimer Professor of Science and Technology Studies at Harvard University’s John F. Kennedy School of Government. She has held academic positions at Cornell, Yale, Oxford, Cambridge, Kyoto, and the Berlin Institute for Advanced Study. Her research centers on the role of science and technology in the law, politics, and public policy of modern democracies. Her books include Controlling Chemicals (1985), The Fifth Branch (1990), Science at the Bar (1995), and Designs on Nature (2005). Dr. Jasanoff has served on the Board of Directors of the American Association for the Advancement of Science and as President of the Society for Social Studies of Science. Sandra Kweder, M.D., is Deputy Director of the FDA’s Office of New Drugs (OND), with oversight of over 700 scientific staff who review all investigational drug products and new drug marketing applications, including those for therapeutic biologics. She also directly oversees special project teams in OND, including a team devoted to development of standards for study endpoints and labeling claims, particularly patient

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary reported outcomes; and a team dedicated to developing new regulations and scientific standards for studying and labeling drugs for safe use in pregnancy and lactation. She has recently taken on oversight of the FDA’s Pediatrics Drug Development Team. Dr. Kweder is board certified in Internal Medicine and continues to practice and teach on a weekly basis at the Uniformed Services University and National Naval Medical Center. She has a special interest and fellowship training in Obstetric Medicine, the care of pregnant women with complicated medical conditions. She has had previous positions in the FDA in the areas of infectious disease products and in postmarketing safety. Jeffrey M. Leiden, M.D., Ph.D., was president and chief operating officer, Pharmaceutical Products Group at Abbott until March, 2006. Prior to Abbott, Leiden served as the Elkan R. Blout professor of biological sciences, Harvard School of Public Health and professor of medicine, Harvard Medical School. Prior to that, he was the Frederick H. Rawson Professor of Medicine and Pathology and Chief of the Section of Cardiology at the University of Chicago. His extensive business and consulting experience includes both the pharmaceutical and medical device arenas. He was a founder of Cardiogene, Inc., a biotechnology company specializing in cardiovascular gene therapy. Dr. Leiden currently serves on the board of directors of TAP Pharmaceutical Products, Inc., the Ravinia Festival, the PENN Medicine Board at the University of Pennsylvania, and A*Star. He is a member of the American Society of Clinical Investigation and the American Association of Physicians, and a fellow of the American Academy of Arts and Sciences. He was elected to the Institute of Medicine of the National Academy of Sciences in 2001. Leiden earned a bachelor’s degree in biological sciences, a doctorate in virology, and a medical degree, all from the University of Chicago. Lawrence J. Lesko, Ph.D., F.C.P., has been the Director of the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA) since 1995. The main focus of the Office of Clinical Pharmacology is the translational analysis of dose-response and PK-PD data for the purposes of optimizing dosing and the benefit/risk ratio of FDA-approved drugs, the use of PK and biomarkers to assist in dosing adjustments for drug-drug interactions, special populations (e.g., renal patients), and other patient subsets defined by pharmacogenomics, individualization of drug therapy using plasma drug levels, and the application of quantitative methods such as disease state progression models and simulations to design clinical trials. Outside the FDA, Dr. Lesko has served as President of the American College of Clinical Pharmacology from 2004–2006. Prior to joining the FDA, Dr. Lesko

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary was a faculty member in academia for over 15 years, most recently at the University of Maryland. He has directed the clinical pharmacology laboratory at the University of Massachusetts Medical Center, and was Vice-President of PharmaKinetics Laboratories, a Baltimore-based contract research organization. He has been appointed as an adjunct professor at the University of Florida and at the University of Southern California in the Colleges of Pharmacy where he lectures and interacts with graduate students. Dr. Lesko is an American Association of Pharmaceutical Scientist (AAPS) Fellow and is Board Certified in Clinical Pharmacology by the American Board of Clinical Pharmacology. He has received the 2007 Rawls–Palmer Progress in Medicine Award from the American Society of Clinical Pharmacology and Therapeutics, the 2007 University of North Carolina Institute for Pharmacogenomics and Individualized Therapy for public service and clinical science, and will receive the Nathaniel T. Kwit Memorial Distinguished Service Award from the American College of Clinical Pharmacology in September 2007 for his contributions to the field of clinical pharmacology. He is a member of the editorial board of several prestigious journals including the Journal of Clinical Pharmacology. He has over 145 publications in peer-reviewed journals and is a frequent invited speaker nationally and internationally. Isaac Lipkus, Ph.D., a health psychologist, is an Associate Professor and Chief of the Behavioral Branch within Duke University Medical Center’s Program of Cancer Prevention, Detection and Control. He is nationally and internationally known as an expert in the area of risk communication, and has published over 75 articles in the leading health communication journals. He is Director of the acclaimed Duke University Medical Center’s Risk Communication Lab (RCL). The RCL is devoted to developing novel persuasive and educational health communications generally and risk communication approaches specifically to affect preventative behaviors (e.g., diet, exercise, smoking cessation), cancer screening (e.g., breast and colorectal cancer), and medical decision making (e.g., breast cancer treatment, chemoprevention for breast cancer). These laboratory and randomized field trial studies, which now total over 30 studies involving over 2,600 participants of varied backgrounds, have tested optimal approaches for communicating cancer risks utilizing several media variables including different numerical, verbal and visual formats. His research also includes testing new frontiers of genetic risk communication (e.g., how genetic susceptibility affects smoking cessation)—he currently serves as a consultant to the National Human Genome Research Institute in their efforts to develop effective genetic risk communications. Overall, his research programs have resulted in several funded initiatives—approximately four million dollars in direct grant support and

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary about two million dollars in indirect grant support—primarily from the Department of Defense and the National Cancer Institute. Dr. Lipkus serves on various editorial boards and regularly consults with the leading health organizations in the country. In addition to being a frequently-invited speaker at several universities and research institutes, Dr. Lipkus has taught graduate seminars in risk communication and persuasion, among other topic areas. J. Marc Overhage, M.D., Ph.D., is associate professor of medicine at the Indiana University School of Medicine, senior investigator at the Regenstrief Institute, and President and CEO of the Indiana Health Information Exchange. Dr. Overhage received his BA with high honors in physics from Wabash College, his Ph.D. in biophysics, and M.D. from Indiana University School of Medicine. Dr. Overhage was a resident in internal medicine, a medical informatics and health services research fellow and then chief medical resident at the Indiana University School of Medicine. Dr. Overhage has over 25 years of computing experience, including developing one of the earliest commercial object-oriented database systems. Over the last 10 years, he has been developing a regional health information exchange to integrate flows of clinical information between public health providers and other clinicians: making immunization registry data from public health department available to providers, creating regional electronic laboratory reporting, implementing and studying reminders to emergency medicine physicians to screen for selected conditions during outbreaks, and, most recently, working with Dr. Shaun Grannis to create the Public Health Electronic Syndromic Surveillance system for the state of Indiana. He has contributed to the development and implementation of the clinical data standards that underlay the Public Health Information Network and tested these standards in hospitals across the country. Dr. Overhage is a fellow of the American College of Medical Informatics and the American College of Physicians. He received the Davies Recognition Award for Excellence in Computer-Based Patient Recognition for the Regenstrief Medical Record System. Dennis J. Paustenbach, Ph.D., is currently the President of ChemRisk, a human and ecological risk assessment consulting firm with four offices nationwide. He was previously the President of McLaren-Hart, a 600 person consulting environmental engineering firm and was a Vice President at Exponent (formerly Failure Analysis Associates). He was the founder of ChemRisk, the largest risk-assessment consulting firm in the United States during the 1990s and has resurrected the firm as of June 2003. He earned a BS in Chemical Engineering, an M.S. in industrial hygiene/toxicology, and a Ph.D. in Environmental Toxicology. He is board-certified in toxicology,

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary industrial hygiene, and safety and has more than 20 years of experience in risk assessment, environmental engineering, ecotoxicology, and occupational health. Dr. Paustenbach has specialized in exposure assessment and dose reconstruction for much of the past 15 years and has published about 40 articles and 7 book chapters on the topic. He has presented guest lectures and short courses on exposure assessment throughout the United States and at least five other countries. He has been an adjunct professor at several universities and was a visiting scholar at the Center for Risk Analysis at Harvard. Dr. Paustenbach has directed consulting activities for nearly 700 risk assessments and has published more than 250 peer-reviewed manuscripts in this and related fields. He is the editor of the most popular textbook on risk assessment, Human and Ecological Risk Assessment: Theory and Practice. Dr. Paustenbach was identified as the best Risk Practitioner within the SRA in 1998 and was awarded the Arnold J. Lehman award by the Society of Toxicology in 2002 in recognition of his contributions to the field of risk assessment. He is the founding editor of the Journal of Children’s Health. Jonathan M. Samet, M.D., M.S., pulmonary physician and epidemiologist, is currently Professor and Chairman of the Department of Epidemiology of the Johns Hopkins Bloomberg School of Public Health. His career has centered on epidemiologic research on threats to public health and using research findings to support policies that protect population health. His research has addressed indoor and outdoor air pollution, smoking, radiation risks, cancer etiology and outcomes, and sleep. Dr. Samet received a Bachelor’s degree from Harvard College, an M.D. degree from the University of Rochester School of Medicine and Dentistry, and a M. S. degree in epidemiology from the Harvard School of Public Health. From 1978 through 1994, he was in the Department of Medicine at the University of New Mexico. Dr. Samet has participated in diverse activities related to translation of scientific evidence into public policy. He has served as author and editor for Surgeon General’s Reports on smoking and testified against the tobacco industry in litigation brought by Minnesota and the Department of Justice. He has served on the EPA Science Advisory Board and was Chairman of the Biological Effects of Ionizing Radiation (BEIR) Committee VI and the Committee on Research Priorities for Airborne Particulate Matter of the National Research Council (NRC). He presently chairs NRC’s Board on Environmental Studies and Toxicology (BEST). He has served on numerous advisory and review groups for the NIH. He has long been active in ATS, chairing the EOH Assembly, and participating in preparing many ATS statements and in the international respiratory epidemiology courses. He was Associate Editor for the American Review of Respiratory Disease. He has served on ALA committees of the concerned

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary with air pollution issues. He has also been president of the Society for Epidemiologic Research and the American College of Epidemiology. He was elected to the Institute of Medicine in 1997, and is an Honorary Fellow of the American College of Chest Physicians. Other honors include the Surgeon General’s Medallion, the Prince Mahidol Award, the Harvard School of Public Health Alumni Award of Merit and the George W. Comstock Award from the Maryland Thoracic Society. Kevin A. Schulman, M.D., M.B.A., is professor of medicine and vice chair for business affairs in the Department of Medicine in the Duke University School of Medicine. He also serves as director of the Center for Clinical and Genetic Economics at the Duke Clinical Research Institute and as professor of business administration, director of the Health Sector Management Program, and director of the Center for the Study of Health Management in The Fuqua School of Business at Duke University. Dr. Schulman’s research centers on three broad themes: economic evaluation in clinical trials; health services research, including access to care and the impact of managed care on clinical practice; and clinical decision making, especially the assessment of decision making for patients with life-threatening diseases. Dr. Schulman has written extensively on his research topics, including peer-reviewed publications in the New England Journal of Medicine, the Journal of the American Medical Association, and Annals of Internal Medicine. He is currently a member of the editorial/advisory boards of seven journals, including the American Journal of Medicine, the American Heart Journal, Health Services Research, and Value in Health. Dr. Schulman also holds appointments in the Duke Center for Clinical Health Policy and the Durham VA Health Services Research Unit. Lisa M. Schwartz, M.D., M.S., is a general internist at the White River Junction Veterans Administration in Vermont and co-director of the VA Outcomes Group, and an associate professor of medicine and community and family medicine at Dartmouth Medical School. Dr. Schwartz’s work (in collaboration with Steven Woloshin) focuses on improving the communication of medical information to patients, physicians, journalists, and policymakers, has appeared in leading medical journals. Their work has focused on creating and testing practical ways to overcome two important barriers to good communication: (1) many people (patients, providers, journalists) are limited in their ability to interpret medical data; and (2) exaggerated and incomplete health messages are common. To this end, they are developing and testing material to help people understand medical statistics and the benefits and harms of prescription drugs, teach several medicine in the media workshops for journalists and write an occasional series for the Washington Post entitled “Healthy Skepticism.”

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary Paul J. Seligman, M.D., M.P.H., current serves as the Associate Director for Safety Policy and Communication in the FDA’s Center for Drug Evaluation and Research. He previously directed the Office of Pharmacoepidemiology and Statistical Science responsible for FDA’s post-marketing drug surveillance, epidemiology and biostatistics programs. Prior to joining the FDA in July 2001, Dr. Seligman served as the Deputy Assistant Secretary for Health Studies at the Department of Energy where he was responsible for occupational medicine, health surveillance and epidemiology related to nuclear weapons production nationally and internationally. In 1994, Dr. Seligman was an American Political Science Association Congressional Fellow working in the office of Senator Paul Wellstone on the health care reform legislation. From 1983–1993, he worked at the Centers for Disease Control (CDC)/National Institute for Occupational Safety and Health (NIOSH) serving as an Epidemic Intelligence Officer, a Preventive Medicine Resident on assignment of the Ohio Department of Health, and as Chief of the Medical Section of NIOSH’s Surveillance Branch. Prior to joining CDC, he completed a primary care internal medicine residency at The Cambridge Hospital in Cambridge, Massachusetts. From 1974–1976, he served as a Peace Corps volunteer in Kenya. Dr. Seligman is a commissioned officer in the U.S. Public Health Service. He holds an M.D. degree from the University of California, Davis, an M.P.H. in industrial health from the University of Michigan, and a B.S. in chemistry from Yale University. He is board certified in internal medicine, occupational medicine, and public health and general preventive medicine. He is the author and co-author of numerous articles and book chapters focusing on work-related injuries and illnesses, including occupational lead exposures and lead poisoning, skin disorders, carpal tunnel syndrome, and public health surveillance. David E. Slavin, M.D., MFOM, is the Executive Director of the Business Innovation Unit (BIU), World Wide Development, Pfizer Global Research and Development. Since joining Pfizer, Dr. Slavin has been Global Head of Risk Technology within Clinical Technology, directing applied risk research to address the current societal trend towards risk aversion and precaution, by studying risk perception, trust and tolerability of risk. Most recently, he has been examining new opportunities for business improvements, value creation and value protection in the context of future healthcare paradigms. Dr. Slavin trained both as a family practitioner and occupational physician. Whilst in the Royal Navy Submarine Service he was deputy nuclear safety regulator for the UK Ministry of Defense and on exchange, the Principal Investigator for a U.S. Navy program involved in submarine atmosphere safety. These different industries required techniques, principles and strategies to answer the “how safe is safe enough?”

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary question and to place the answers in a risk informed context. Dr. Slavin is based in Sandwich, UK, for this global position. Paul Slovic, Ph.D., is president of Decision Research and a professor of psychology at the University of Oregon. He studies human judgment, decision making, and risk analysis, and has published extensively on these topics. Dr. Slovic received a B.A. degree from Stanford University, M.A. and Ph.D. degrees from the University of Michigan, and honorary doctorates from the Stockholm School of Economics and the University of East Anglia. Dr Slovic has served on numerous advisory committees of the National Research Council/National Academy of Sciences, including the committees that wrote Risk Assessment in the Federal Government: Managing the Process (1983) and Understanding Risk: Decision Making in a Democratic Society (1996). Harold C. Sox, M.D., graduated from Stanford University (B.S. physics) and Harvard Medical School. After serving as a medical intern and resident at Massachusetts General Hospital, he spent two years doing research in immunology at the National Institutes of Health and three years at Dartmouth Medical School, where he served as chief medical resident and began his studies of medical decision making. He then spent fifteen years on the faculty of Stanford University School of Medicine, where he was the chief of the division of general internal medicine and director of ambulatory care at the Palo Alto VA Medical Center. In 1988 he returned to Dartmouth where he served for thirteen years as Joseph M. Huber Professor of Medicine and chair of the department of medicine. He became the Editor of the Annals of Internal Medicine in 2001. Dr. Sox was the President of the American College of Physicians during 1998–1999. He chaired the U.S. Preventive Services Task Force from 1990 to 1995, the Institute of Medicine Committee to Study HIV Transmission through Blood Products, and the Institute of Medicine Committee on Health Effects Associated with Exposures Experienced in the Gulf War. He chaired the Medicare Coverage Advisory Committee of the Center for Medicare Services from 1999 to 2003 and served on the Report Review Committee of the National Research Council from 2000 to 2005. He was elected to the Institute of Medicine of the National Academies in 1993 and to fellowship in the American Association for the Advancement of Science in 2002. His books include Medical Decision Making, Common Diagnostic Tests: Selection and Interpretation, and Graduate Education in Internal Medicine: a Resource Guide. Carl C. Spetzler, Ph.D., is chairman of Strategic Decisions Group (SDG). Specializing in strategy development, business innovation, and strategic

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary change management, Dr. Spetzler has developed creative business strategies for major financial institutions, capital-intensive companies, high-technology manufacturers, and systems businesses. Over the past 20 years, he has been a leader in designing an innovative strategy development process that helps corporate leaders cope with the lack of explicit strategic alternatives, deal with the complexities of uncertainty and risk over long time horizons, and achieve lasting change. In addition to serving as the chairman of the board for SDG, Dr. Spetzler works with top management and boards of directors to improve the quality of decisions. His methods stress that boards be collaboratively engaged in a few truly strategic decisions rather than simply serve in an approval role on a myriad of items. Before the founding of SDG, Dr. Spetzler directed the Financial Industries and Strategic Methodologies Center at SRI International. He received an M.B.A. and a Ph.D. in economics and business administration and BS in chemical engineering from the Illinois Institute of Technology (IIT). He serves on the boards of IIT and the Decision Education Foundation, a nonprofit organization dedicated to improving the decision-making skills of youth. In 2004, Dr. Spetzler received The Ramsey Medal, the highest honor awarded by the Decision Analysis Society of INFORMS for lifetime contributions to the field. Brian L. Strom, M.D., M.P.H., is the George S. Pepper Professor of Public Health and Preventive Medicine at the University of Pennsylvania. He is Founding Director of the Center for Clinical Epidemiology and Biostatistics. The mission of the Center is to improve the health of the public by linking epidemiology, biostatistics, and clinical medicine, bringing epidemiologic research methods to clinical research, clinical insight to epidemiologic research, and an understanding of research methodology to clinical medicine. Since its inception in 1993, the Center has grown to more than 160 faculty members, with an annual budget exceeding $50 million. Dr. Strom earned his M.D. degree from Johns Hopkins University and his M.P.H. degree in epidemiology from the University of California at Berkeley. Dr. Strom also serves as Chair of the Department of Biostatistics and Epidemiology and has appointments in the departments of Medicine and Pharmacology. Recently, he was appointed Associate Vice Dean of the University of Pennsylvania School of Medicine and Associate Vice President for Strategic Integration for the University of Pennsylvania Health System. While Dr. Strom’s research interests span many areas of epidemiology, his major career interest is pharmacoepidemiology, and he has written the major textbook in this field, now going into its fourth edition. In addition, he has more than 400 publications. Editor for the Americas for Pharmacoepidemiology and Drug Safety, Dr. Strom served on the Drug Safety and Risk Management Advisory Committee for the United States

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary Food and Drug Administration. He was previously President of the International Society for Pharmacoepidemiology. He is the immediate past President of the Association for Clinical Research Training. He was a member of the Board of Regents of the American College of Physicians, the Board of Directors of the American Society for Clinical Epidemiology and Therapeutics, and the Board of Directors of the American College of Epidemiology. A member of the Institute of Medicine of the National Academy of Sciences, he chaired the institute’s Committee to Assess the Safety and Efficacy of the Anthrax Vaccine and was recently Chair of its Committee on Smallpox Vaccine Program Implementation. Among his many honors is the 2003 Rawls–Palmer Progress in Medicine Award from the American Society of Clinical Pharmacology and Therapeutics. Douglas C. Throckmorton, M.D., is the Deputy Director in the Center for Drug Evaluation and Research at the FDA. As a physician, he is Board-Certified in Internal Medicine and Nephrology, having received his training at Case Western Reserve University and Yale University. He practiced medicine at the Medical College of Georgia in Augusta, Georgia, until coming to the FDA in 1997. He began his career at the FDA in the Division of Cardio-Renal Drug Products, first as a Medical Reviewer, then as the Deputy Division Director and from 2002 until 2005 as the Division Director. Peter A. Tollman, Ph.D., is a senior vice president in BCG’s Boston office. For many years he led BCG’s healthcare R&D business and now directs the global healthcare innovation and marketing agenda more broadly. Peter has served many leading pharmaceutical firms and has managed numerous assignments across all functions of the value chain. He has directed BCG’s assessment of R&D productivity and is principal author of BCG’s publications on the economics of R&D. Peter joined The Boston Consulting Group in 1989. Outside BCG Dr. Tollman co-founded and was managing director of a health care investment company, MPM Capital. He is a Governor of the Jerusalem Academy of Music and Dance at the Hebrew University. Peter received his Ph.D. in engineering from the University of Cape Town and his M.B.A. with distinction from Columbia Business School. Peter A. Ubel, M.D., is professor of medicine and professor of psychology at the University of Michigan, a primary care physician at the Ann Arbor Veterans Affairs Medical Center, Associate Director of the Michigan Robert Wood Johnson Clinical Scholars Program, and Director of the Center for Behavioral and Decision Sciences in Medicine at the University of Michigan. His research explores controversial issues about the role of

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary values and preferences in health care decision making, from decisions at the bedside to policy decisions. He uses the tools of decision psychology and behavioral economics to explore topics like informed consent, shared decision making and health care rationing. He is currently Principal Investigator of 3 RO1s from the NIH. Dr. Ubel has won many research awards, including a Presidential Early Career Award for Scientists and Engineers from President Clinton in 2000. He has written over 100 scientific articles, and his research has been widely reported on in the popular media. He is author of Pricing Life: Why It Is Time for Health Care Rationing (MIT Press 2000), and You’re Stronger Than You Think: Tapping the Secrets of Emotionally Resilient People (McGraw-Hill 2006). Steven Woloshin, M.D., M.S., is a general internist at the White River Junction Veterans Administration in Vermont and a senior researcher in the VA Outcomes Group, and an associate professor of medicine and community and family medicine at Dartmouth Medical School. Dr. Woloshin’s work (in collaboration with Lisa Schwartz) focuses on improving the communication of medical information to patients, physicians, journalists, and policymakers, and has appeared in leading medical journals. Their work has focused on creating and testing practical ways to overcome two important barriers to good communication: (1) many people (patients, providers, journalists) are limited in their ability to interpret medical data; and (2) exaggerated and incomplete health messages are common. To this end, they are developing and testing material to help people understand medical statistics and the benefits and harms of prescription drugs, teach several medicine in the media workshops for journalists and write an occasional series for the Washington Post entitled “Healthy Skepticism.”

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