Appendix C

Contributors

MICHAEL L. BURSTALL is a partner in REMIT Consultants Limited, London, an economic consulting group. He has been active in research in the pharmaceutical industry for many years, and has published a number of reports on its various aspects, including studies of the role of multinational companies, the European pharmaceutical industry, and American drug companies in Britain and Europe. He was the principal author of the part of the Cecchini report that dealt with the impact of the 1992 harmonization of the European common market on the sector. A chemist by training, Dr. Burstall has worked for Procter & Gamble in Newcastle, England, and Cincinnati, Ohio, and has taught at the University of Surrey, where he built up an interdisciplinary research team studying problems in the areas of technology, economics, and politics. He was educated at Oxford University, and his Ph.D. concerned the synthesis of tetracycline antibiotics.

SOPHIA W. CHANG is a National Center for Health Services Research fellow in health services research at the Institute for Health Policy Studies of the University of California, San Francisco (UCSF), and the School of Public Health at the University of California, Berkeley (UCB). Dr. Chang is also a clinical instructor of medicine at UCSF. Her primary research interest is in issues of health care access for the uninsured. She recently completed a study of the working uninsured using public hospital services in San Francisco. Her clinically oriented work deals with quality of life outcome measures, most recently in conjunction with trials testing the potential side effects of diuretic treatment for hypertension. She received her undergraduate degree in political science at Amherst College and her medical degree at the



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The Changing Economics of Medical Technology Appendix C Contributors MICHAEL L. BURSTALL is a partner in REMIT Consultants Limited, London, an economic consulting group. He has been active in research in the pharmaceutical industry for many years, and has published a number of reports on its various aspects, including studies of the role of multinational companies, the European pharmaceutical industry, and American drug companies in Britain and Europe. He was the principal author of the part of the Cecchini report that dealt with the impact of the 1992 harmonization of the European common market on the sector. A chemist by training, Dr. Burstall has worked for Procter & Gamble in Newcastle, England, and Cincinnati, Ohio, and has taught at the University of Surrey, where he built up an interdisciplinary research team studying problems in the areas of technology, economics, and politics. He was educated at Oxford University, and his Ph.D. concerned the synthesis of tetracycline antibiotics. SOPHIA W. CHANG is a National Center for Health Services Research fellow in health services research at the Institute for Health Policy Studies of the University of California, San Francisco (UCSF), and the School of Public Health at the University of California, Berkeley (UCB). Dr. Chang is also a clinical instructor of medicine at UCSF. Her primary research interest is in issues of health care access for the uninsured. She recently completed a study of the working uninsured using public hospital services in San Francisco. Her clinically oriented work deals with quality of life outcome measures, most recently in conjunction with trials testing the potential side effects of diuretic treatment for hypertension. She received her undergraduate degree in political science at Amherst College and her medical degree at the

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The Changing Economics of Medical Technology College of Physicians and Surgeons at Columbia University. Prior to beginning her fellowship, Dr. Chang completed residency training in primary care general internal medicine at UCSF. She has completed an M.P.H. degree at UCB. SUSAN BARTLETT FOOTE is an associate professor of business and public policy at the Walter A. Haas School of Business, University of California, Berkeley and a member of the faculty at the School of Public Health at Berkeley. Professor Foote has written widely in the field of safety regulation and business-government relations, with a special emphasis on medical devices. Her work has appeared in the Journal of Health Policy, Politics and Law, Milbank Quarterly, and numerous law and business journals. Her book on the influence of public policy on medical device innovation is forthcoming from California University Press. Professor Foote is a member of the Institute of Medicine (IOM) Committee on Technological Innovation in Medicine and the Forum on Drug Development. She served as a consumer representative for the Office of Device Evaluation at the Food and Drug Administration and contributed to reports of the Office of Technology Assessment of the U.S. Congress. She holds a J.D. degree from Boalt Hall, UCB. In 1990-1991, she is a Robert Wood Johnson Health Policy Fellow working on issues of medical technology in the U.S. Senate. ANNETINE C. GELIJNS joined the Institute of Medicine (IOM) as an international fellow, and now is the study director for the IOM Committee on Technological Innovation in Medicine. Before joining the IOM, she was senior researcher for the Project on Future Health Care Technology, cosponsored by the European office of the World Health Organization (WHO) and the Dutch Government. From 1983 to 1985 Ms. Gelijns worked for the Steering Committee on Future Health Scenarios, where she helped develop models for long-term health planning in the areas of cancer, cardiovascular disease, and aging. At the time, she had a joint appointment with the Staff Bureau for Health Policy Development, the Department of Health, the Netherlands. Ms. Gelijns has been a consultant to various national and international organizations, including the WHO and the Organization for Economic Cooperation and Development. Her research interests are in the dynamics of the development process of drugs, devices and clinical procedures. In 1983 she received her LL.M. degree from the University of Leyden, and she will receive her Ph.D. degree from the medical faculty, the University of Amsterdam in August 1991. She is a member of the board of the International Society on Technology Assessment in Health Care. HENRY GRABOWSKI has been at Duke University since 1972, where he is currently professor of economics. He is also director of the Program in Pharmaceuticals and Health Economics, which is part of the Center for

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The Changing Economics of Medical Technology Business, Regulation, and Economic Policy. Dr. Grabowski's principal research interests involve the economics of the innovation process, business regulation, and industrial organization. He has published numerous studies on the pharmaceutical industry. Under a series of grants from the National Science Foundation, he has investigated the international diffusion of new drugs and the effects of various government policy decisions on drug innovation. He is the author of two books published by the American Enterprise Institute, The Regulation of Pharmaceuticals: Balancing the Benefits and Risks (1983) and Drug Regulation and Innovation (1976). He has also authored cost-benefit studies of government regulatory actions in various other industrial sectors. Dr. Grabowski has been an advisor and consultant to several organizations, including the National Academy of Engineering, the Federal Trade Commission, the General Accounting Office, and the Office of Technology Assessment. He has also served on the faculty of Yale University and held visiting appointments at the Health Care Financing Administration in Washington, D.C., and the International Institute of Management in Berlin, Germany. He received his undergraduate degree in engineering physics at Lehigh University and his doctorate in economics from Princeton University. ETHAN A. HALM received his undergraduate education at Wesleyan University and will graduate from the Yale University School of Medicine in May 1991. During 1989-1990, he worked as a research associate for the Institute of Medicine (IOM) Committee on Technological Innovation in Medicine and the Council on Health Care Technology. In addition to his involvement with this book and its antecedent conference on Public Policy and the Economics of Innovation, he worked on the IOM report National Priorities for the Assessment of Clinical Conditions and Medical Technologies. He also helped run an IOM conference on Improving Methods of Consensus Development for Medical Practice and Technology Assessment. His research interest includes the impact of payment policies on innovation, medical decision making, and molecular neuroscience. At Yale, he has been actively involved in medical education reform and the teaching of medical ethics. He will begin residency training in internal medicine in July 1991. PETER BARTON HUTT is a partner in the Washington, D.C., law firm of Covington & Burling, specializing in food and drug law and in the government regulation of health and safety. He began his practice of law with Covington & Burling in October 1960, and became a partner in 1968. From 1971 to 1975 he was chief counsel for the Food and Drug Administration (FDA). In September 1975 he returned to private law practice with Covington & Burling. During his service as chief counsel for FDA, Mr. Hutt was instrumental in establishing the over-the-counter drug review and the biological drugs review and in shaping the drug efficacy study implementation

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The Changing Economics of Medical Technology (DESI) program for pre-1962 new drugs. He also participated in drafting the Drug Listing Act of 1972, the Consumer Product Safety Act of 1972, and the Medical Device Amendments of 1976. Mr. Hutt is a member of the Institute of Medicine (IOM) and, at the time of writing the paper contained in this volume, of the presidentially appointed National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS (a.k.a. the Lasagna Committee). Mr. Hutt has coauthored (with Professor Richard A. Merrill) a legal casebook, Food and Drug Law: Cases and Materials (Foundation Press, 1980) and serves on the editorial boards of several journals. He holds a B.A. from Yale University, an LL.B. from Harvard University, and an LL.M. from New York University, and he is a member of the New York, District of Columbia, and Supreme Court Bars. JOHN HUTTON is senior research fellow at the Center for Health Economics at the University of York, United Kingdom. He is responsible for managing the Center's program of research and teaching in the field of medical technology. This ranges from studies of specific technologies, such as magnetic resonance imaging and computerized tomography, to the study of organizational structures and the organization of courses on the principles of economic evaluation. Current projects include evaluation of the use of information technology in health care, the economics of cancer treatment, and the effects of National Health Service reforms on the use of medical technologies in the United Kingdom. Mr. Hutton is responsible for organizing the U.K.-based Health Economists' Study Group, and he is an active member of the International Society for Technology Assessment in Health Care. Recent consultant work has included studies for the World Bank, World Health Organization, U.K. government, and medical equipment companies. Prior to joining the Center, he was a research fellow in the Institute of Social and Economic Research at the University of York, where his work focused on the U.K. medical equipment market. He has also worked for the Transport Planning Department of Strathclyde Regional Council in Glasgow and taught economics at the University of Aberdeen. He received a B.Sc. Econ. degree from the London School of Economics and a master degree in the economics of public finance at the University of York. ALAN KAHN is president of Human Dimensions, Inc., and a research professor of electrical and computer engineering at the University of Cincinnati. Dr. Kahn is a physician and private consultant with extensive experience in biomedical engineering applications and in the development of new products for clinical use. His research interests include the application of new research in brain physiology, artificial intelligence, human behavior, and communications. From 1982 to 1985 he served in a panel assessing federal policies and the medical device industry for the Office of Technological Assessment of the U.S. Congress. He also helped organize the Alliance of Engineering in

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The Changing Economics of Medical Technology Biology and Medicine and served as its third president in 1973. From 1970 to 1977 Dr. Kahn was senior vice president for research and development at Medtronic, Inc., in Minneapolis, Minnesota. Dr. Kahn is a fellow of the Institute of Electrical and Electronics Engineers, the American College of Cardiology, and the American College of Chest Physicians. HAROLD S. LUFT is professor of health economics and associate director of the Institute for Health Policy Studies at the University of California, San Francisco. His research has covered a wide range of health policy areas, including applications of benefit cost analysis, studies of medical care utilization, the relationship between volume of selected medical and surgical patients in hospitals and hospital mortality, regionalization of hospital services, duplication of health insurance coverage, adverse selection in multiple-option health insurance settings, competition in the medical care market, and health maintenance organizations. In addition to numerous articles in scientific journals, he has authored Poverty and Health: Economic Causes and Consequences of Health Problems (Ballinger, 1978) and Health Maintenance Organizations: Dimensions of Performance (Wiley-Interscience, 1981/Transaction Books, 1988). Prior to coming to the University of California, San Francisco, in 1978, Dr. Luft was an assistant professor in the Health Services Research Program at Stanford University. Professor Luft is a member of the Institute of Medicine (IOM) and serves on the IOM governing council. He has also participated in study sections and review panels of the Agency for Health Care Policy and Research, Health Care Financing Administration, and numerous private foundations. He is on the editorial board of the Journal of Health Politics, Policy and Law, Medical Care Review, Inquiry, and Health Services Research. He received his undergraduate and graduate training at Harvard University, majoring in economics with a specialization in health economics. LEE MORTENSON has served as the executive director of the Association of Community Cancer Centers since 1978, overseeing the daily management of the association and acting as liaison with a number of national cancer organizations, including the National Cancer Institute and American Cancer Society. Dr. Mortenson is also the chief executive officer of ELM Services, Inc., which provides consulting and data management services to the health care community and markets tumor registry software. He has served as project manager and special consultant to a number of organizations, institutions, and government agencies on health care issues relating to organizational design and development. He has also been involved in the development and evaluation of institutional plans; certificates of need; patient load projections of university-based, interdisciplinary cancer centers and multicenter consortia of community hospitals; and single institution programs. Dr. Mortenson has authored over 100 books, monographs, articles, abstracts, and limited

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The Changing Economics of Medical Technology circulation reports, and he has spoken widely on health policy issues. He completed his doctorate in public administration through the University of Southern California, Washington Public Affairs Center. ROBERT NEIMETH is a vice president of Pfizer, Inc., and president of Pfizer International, Inc., with responsibility for the pharmaceutical business in Europe, Africa, the Middle East, Eastern Europe, the USSR, China, Japan, and Korea. He joined Pfizer in 1962, and prior to his current position served as president of Pfizer Europe, vice president and director of operations, Pfizer Laboratories in the United States, and president of Pfizer Asia. Twenty of his twenty-seven years with the company have been spent abroad, with assignments in West Africa, Europe, and the Far East. He is a graduate of Cornell University, with a degree in anthropology and sociology granted in 1957. PETER J. NEUMANN is Special Assistant to Administrator Gail R. Wilensky at the Health Care Financing Administration. He is currently on leave of absence from the doctoral program at the Harvard University School of Public Health where he is studying health economics and health decision sciences in the Department of Health Policy and Management. He has coauthored a number of papers and reports regarding payment policies for new technologies. Previously, he worked as a health policy analyst at the Project HOPE Center for Health Affairs. At the time the paper contained in this volume was written, he was a student at Harvard. MILTON C. WEINSTEIN is the Henry J. Kaiser Professor of Health Policy and Management at the Harvard School of Public Health, where his major activities include research and teaching on the cost-effectiveness of health care and medical technologies. He joined the faculty of the Harvard School of Public Health as a full professor in 1980 and became the Henry J. Kaiser Professor of Health Policy and Management in 1986. Dr. Weinstein's research concerns the use of quantitative models to guide health care resource allocation. He has contributed to the development of the methods of decision analysis and cost-effectiveness analysis in health care and has applied them to assess technologies for coronary heart disease, postmenopausal hormone replacement, childhood immunization, and numerous other problems. He is the principal author of two books, Clinical Decision Analysis (with Harvey V. Fineberg) and Hypertension: A Policy Perspective (with William B. Stason), and of more than 60 publications in peer-reviewed journals, ranging from the New England Journal of Medicine and Science to Operations Research and the Quarterly Journal of Economics. Dr. Weinstein, a member of the Institute of Medicine, is a past president of the Society for Medical Decision Making, and a current member of the editorial board of its journal, Medical Decision Making. During 1986 and 1987, while on sabbatical leave from

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The Changing Economics of Medical Technology Harvard, he served as special assistant to the chief administrative officer of the New England Medical Center Hospital. Dr. Weinstein earned his A.B. and A.M. in applied mathematics at Harvard University in 1970, an M.P.P. from the John F. Kennedy School of Government in 1972, and a Ph.D. in public policy at Harvard in 1973.