APPENDIX B
Committee Biographies

HENRY J. AARON, Ph.D. (Chair), is a Senior Fellow in economic studies at the Brookings Institution. He is currently chair of the board of the National Academy of Social Insurance, president of the Association of Public Policy and Management, and a member and councilor of the American Academy of Arts and Sciences. He was an Assistant Secretary for Planning and Evaluation in the Department of Health, Education, and Welfare during the Carter administration, and is a former chairman of the Advisory Council on Social Security. He has written extensively on financial aspects of the U.S. health care system, including Medicare.

ROBERT M. CALIFF, M.D., is Professor of Medicine in the Division of Cardiology at Duke University Medical Center. He also holds the following titles: Associate Vice Chancellor for Clinical Research and Director of the Duke Clinical Research Institute, as well as editor-in-chief of the American Heart Journal. He has been a principal investigator for some of the largest recent U.S.-based cardiology trials, including CAVEAT (Coronary Angioplasty Versus Excisional Atherectomy Trial), GUSTO (Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries), EPIC (Evaluation of c7E3 Fab for the Prevention of Ischemic Complications), and TAMI (Thrombolysis and Angioplasty in Myocardial Infarction). He has written extensively about clinical and economic outcomes in ischemic heart disease. Dr. Califf was also on the 1969 AAAA South Carolina Championship Basketball team.

KAY DICKERSIN, Ph.D., Associate Professor, Department of Community Health, Brown University School of Medicine, is co-director of the New England Cochrane Center. Her primary academic interests are evidence-based medicine, clinical trial design, and meta-analysis. Dr. Dickersin directs the coordi



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Extending Medicare Reimbursement in Clinical Trials APPENDIX B Committee Biographies HENRY J. AARON, Ph.D. (Chair), is a Senior Fellow in economic studies at the Brookings Institution. He is currently chair of the board of the National Academy of Social Insurance, president of the Association of Public Policy and Management, and a member and councilor of the American Academy of Arts and Sciences. He was an Assistant Secretary for Planning and Evaluation in the Department of Health, Education, and Welfare during the Carter administration, and is a former chairman of the Advisory Council on Social Security. He has written extensively on financial aspects of the U.S. health care system, including Medicare. ROBERT M. CALIFF, M.D., is Professor of Medicine in the Division of Cardiology at Duke University Medical Center. He also holds the following titles: Associate Vice Chancellor for Clinical Research and Director of the Duke Clinical Research Institute, as well as editor-in-chief of the American Heart Journal. He has been a principal investigator for some of the largest recent U.S.-based cardiology trials, including CAVEAT (Coronary Angioplasty Versus Excisional Atherectomy Trial), GUSTO (Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries), EPIC (Evaluation of c7E3 Fab for the Prevention of Ischemic Complications), and TAMI (Thrombolysis and Angioplasty in Myocardial Infarction). He has written extensively about clinical and economic outcomes in ischemic heart disease. Dr. Califf was also on the 1969 AAAA South Carolina Championship Basketball team. KAY DICKERSIN, Ph.D., Associate Professor, Department of Community Health, Brown University School of Medicine, is co-director of the New England Cochrane Center. Her primary academic interests are evidence-based medicine, clinical trial design, and meta-analysis. Dr. Dickersin directs the coordi

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Extending Medicare Reimbursement in Clinical Trials nating center for two federally funded, multicenter randomized trials: The Ischemic Optic Decompression Trial and the Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding. BERTIE A. FORD, M.S., R.N., O.C.N., is a clinical nurse specialist with Amgen. Until taking up this position, she had been Manager of Clinical Research and the Cancer Registry at Grant/Riverside Hospitals, Columbus, Ohio, since February 1998. Earlier, Ms. Ford was Clinical Trials Program Coordinator in the Ohio State University Department of Internal Medicine for most of the period from 1988. During that period she spent a brief time at Pharmacia in clinical research, and earlier, she held various positions with oncology research groups. She has recently been appointed to the steering council of the Oncology Nursing Society and wrote several chapters for the society's clinical trial manual for nurses. She is currently president of the Columbus Chapter of the National Black Nurses Association. Ms. Ford served on the National Cancer Policy Board from 1997 through April 1999. PETER D. FOX, Ph.D., has been an independent consultant specializing in managed care since 1991. For the 10 previous years he was a vice president at Lewin and Associates (now The Lewin Group), a consulting company. His clients include managed care organizations, health care provider groups, employers, Taft-Hartley trust funds, government agencies, and foundations. He previously held positions in the federal government, including serving as Director of the Office of Policy Analysis in the Health Care Financing Administration. He has written three books and many articles and book chapters on issues related to health care financing and delivery with an emphasis on managed care. LANCE LIEBMAN, L.L.B., William S. Beinecke Professor of Law, Columbia University Law School, is Director of Columbia's Parker School of Foreign and Comparative Law and Director of the American Law Institute. He has had a distinguished career in public service and academic law over the past 30 years. From 1991 to 1996, he was Dean of the Columbia University Law School. JOHN M. LUDDEN, M.D., is Associate Clinical Professor, Department of Ambulatory Care and Prevention, Harvard Medical School. Previously, Dr. Ludden was Senior Vice President, Medical Affairs of Harvard Pilgrim Health Care, where he headed the Department of Medical Affairs and Health Policy from 1994 to 1998. Dr. Ludden served as Corporate Medical Director from 1983 to 1994. He joined Harvard Community Health Plan in 1972, where he was a staff psychiatrist and Director of the Kenmore Health Center. Before joining Harvard Community Health Plan, Dr. Ludden served as Director and CoDirector of the Alcohol Clinic at the Peter Bent Brigham Hospital in Boston. He was also Chief of the Psychiatric Division of the Directorate of Mental Hygiene at the U.S. Disciplinary Barracks in Ft. Leavenworth, Kansas, and psychiatrist in the U.S. Army. Dr. Ludden serves on the boards of the National Committee for

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Extending Medicare Reimbursement in Clinical Trials Quality Assurance and the American College of Physician Executives. Dr. Ludden is certified in Psychiatry by the American Board of Psychiatry and Neurology and in Medical Management by the American Board of Medical Management. Dr. Ludden completed his psychiatric residency at the Massachusetts Mental Health Center. He received a B.A. from Harvard College and an M.D. from Harvard Medical School. He completed the program for Management Development at the Harvard Graduate School of Business. ROBERT S. McDONOUGH, M.D., J.D., M.P.P, is Medical Director and Senior Consultant in the Clinical Policy Unit of Aetna U.S. Health care. He is responsible for developing clinical policies and clinical guidelines that apply to all of Aetna U.S. Health care's products (indemnity, PPO, POS, and HMO plans), and for the preventive services guidelines and policies, continuing medical education programs for physicians, and pharmacy formulary evaluations. WILLIAM T. McGIVNEY, Ph.D., has been Chief Executive Officer of the National Comprehensive Cancer Network—an association of the major cancer research centers in the United States—since 1997. In earlier positions, he was vice president for clinical and coverage policy for Aetna Health Plans (and also held other positions with Aetna) and director of the Division of Health Care Technology for the American Medical Association. ROSEMARY ROSSO, J.D., is a breast cancer survivor and a member of the Metropolitan Washington Breast Cancer Coalition and the National Breast Cancer Coalition. Through these organizations, she has worked to encourage greater access to and participation in clinical trials for breast cancer research. Ms. Rosso also holds other local and national cancer patient and advocacy positions, including member of the U.S. Department of Defense Breast Cancer Research Program's Integration Panel. Ms. Rosso is a senior attorney with the Federal Trade Commission. ELIZABETH STONER, M.D., is Vice President for Clinical Research, Endocrine/Metabolism and Contract and Cost Management at Merck. She is responsible for the financing and budgets of clinical trials, including those performed by contract research organizations. BOB THOMPSON, M.S., M.A., Senior Manager, Reimbursement and Economics Department, Medtronic, works in the areas of strategic reimbursement planning, health outcomes, and cost-effectiveness research. He also worked in Medtronic's Neurological Division for 5 years, in the same three areas, as well as in clinical practice guidelines and health outcomes software development. As part of his responsibilities, Mr. Thompson has worked with Medicare and other payers for the past 7 years.

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Extending Medicare Reimbursement in Clinical Trials PETER J. WHITEHOUSE, M.D., Ph.D., is Professor in the Department of Neurology, Psychiatry, Neuroscience, and Biomedical Ethics at Case Western Reserve University School of Medicine. His research focuses on the basic and clinical neuroscience of aging-related diseases, particularly Alzheimer's disease. He has extensive experience in drug trials for Alzheimer's disease, with a special interest in quality of life measurement, bioethics, and geriatric care systems. He has served as a consultant and advisor to numerous national and international professional, government, and private organizations.