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Appendix F Committee Biosketches Ellen Wright Clayton, J.D., M.D. (Chair), is Craig-Weaver Chair in Pediat- rics as well as Professor of Law and the Director of the Center for Biomedi- cal Ethics and Society at Vanderbilt University. Her research and teaching interests include pediatrics, medical and research ethics, legal and ethical issues in children’s and women’s health, and genetics and health policy. She has served as a member on numerous committees for the National Institutes of Health as well as the Ethical, Legal, and Social Issues Working Group of the Newborn Screening Taskforce, Maternal and Child Health Bureau, Health Resources Services Administration. Dr. Clayton has served as a con- sultant to the Food and Drug Administration on the topic of clinical phar- macology during pregnancy. She is a member of the Institute of Medicine (IOM) and has served on several National Academies committees as well as the IOM’s Health Sciences Policy Board and is currently a member of its National Advisory Council. She has numerous publications in books, medi- cal journals, interdisciplinary journals, and law journals on the intersection of law, medicine, and public health. Dr. Clayton received her M.D. from Harvard University in 1985 and her J.D. from Yale University in 1979. Inmaculada B. Aban, Ph.D., M.S., is currently an Associate Professor in the Research Methods and Clinical Trials Section in the Department of Biostatistics at University of Alabama at Birmingham. She has considerable experience in clinical studies and statistical methodology research. She was Director of the Biostatistics Core of the National Institutes of Health (NIH)/ National Heart, Lung, and Blood Institute (NHLBI)-sponsored SCCOR Program on Heart Failure that ended in 2010. She is currently the Deputy 827
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828 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY Director of an international multicenter Data Coordinating Center funded by the National Institute of Neurological Disorders and Stroke (NINDS) on myasthenia gravis, a rare disease. She serves as the primary Biostatistician for Collaborative Antiviral Study Group pediatric trials on rare diseases. She also provides statistical support regarding study design, protocol de- velopment, study monitoring, quality assurance, report generation, and statistical analyses. She has years of experience in writing and presenting Data and Safety Monitoring Board (DSMB) reports. She served as a DSMB member in an NIH/NINDS study and had served as a temporary member of NHLBI study sections. Her current research interests are statistical methods in clinical trials, survival and reliability analysis, analysis of pool screening and count data, goodness-of-fit and model diagnostics, inference for heavy tail distribution, and propensity scores applied to epidemiologic data. Douglas J. Barrett, M.D., is a Professor in the Department of Pediatrics, the Department of Molecular Genetics & Microbiology, and the Depart- ment of Pathology, Immunology, & Laboratory Medicine at the University of Florida College of Medicine. Dr. Barrett is a practicing pediatrician, a researcher, and the author or coauthor of three books, several book chapters, and more than 110 journal articles. Dr. Barrett’s clinical and research expertise is in childhood immune responses, immunodeficiency diseases, and transplantation. His research has been supported by grants from the National Institutes of Health, the American Heart Association, and the American Cancer Society. Dr. Barrett is active in the American Acad- emy of Pediatrics, American Board of Pediatrics, Association for Academic Health Centers, and the Society for Pediatric Research. He serves on the editorial board for Contemporary Pediatrics and is a reviewer for multiple journals. Dr. Barrett received his M.D. in 1974 as a charter class member of the University of South Florida College of Medicine. He completed his pediatric internship training at Tampa General Hospital and All Children’s Hospital. After completing a pediatric residency at SUNY/Upstate Medical Center in New York, he pursued fellowship training in pediatric immunol- ogy in the Department of Pediatrics at the University of California, San Francisco. Dr. Barrett joined the University of Florida in 1980. He served as the Chief of the Division of Pediatric Immunology from 1986 to 1990, as the Chairman of the Department of Pediatrics from 1990 to 2001, and as Senior Vice President for Health Affairs at the University of Florida from 2001 to 2009. In the latter position he was responsible for maximizing the performance of the educational, research, and clinical programs in the six colleges of the University of Florida’s Health Sciences Center. Martina Bebin, M.D., M.P.A., is associate professor of neurology and pe- diatrics at the University of Alabama at Birmingham. She is a practicing
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829 APPENDIX F child neurologist, and her research interests include pediatric clinical drug development for epilepsy and outcomes research of epilepsy patients, with a focus on treatment of epilepsy in children. She has clinical responsibility for the care of children enrolled in a clinical trial supported by Novartis for treatment of tuberous sclerosis patients with subependymal giant cell tumors of the brain. She is currently working on the Tuberous Sclerosis Alliance Natural History Database Project, funded by the Tuberous Scle- rosis Alliance and the Centers for Disease Control and Prevention. She is a former Robert Wood Johnson Foundation Health Policy fellow. Dr. Bebin received her M.D. from the University of Mississippi School of Medicine in 1986. She completed her pediatric and neurology training at the Mayo Clinic in Rochester, Minnesota, and a fellowship in epilepsy at the Univer- sity of Virginia. In 2005 she earned her M.P.A. from Harvard University- Kennedy School of Government. Kirsten Bibbins-Domingo, Ph.D., M.D., M.A.S., is associate professor of medicine and epidemiology and biostatistics at the University of California, San Francisco, and an attending physician at San Francisco General Hos- pital. Dr. Bibbins-Domingo is an active researcher in preventive cardiology, the epidemiology of cardiovascular disease in young adults, and race and gender health and health care disparities. Her research has examined the development of cardiovascular risk factors in young adults, the effectiveness of screening and diagnostic tests for cardiovascular disease, and computer- simulated projections of future cardiovascular disease trends and the impact of public health and clinical interventions on cardiovascular disease preven- tion. Dr. Bibbins-Domingo served on the IOM Committee on Evaluation of the Presumptive Disability Decision-Making Process for Veterans from 2006 to 2007. She received her undergraduate degree in molecular biology and public policy from Princeton University and her medical degree, Ph.D. in biochemistry, and Masters of Clinical Research from the University of California, San Francisco. Martha Constantine-Paton, Ph.D., is investigator at the McGovern Institute for Brain Research and Professor in the departments of Brain and Cognitive Sciences and Biology at the Massachusetts Institute of Technology (MIT). Previously, she was professor of biology at Yale University from 1985 until 1999, and a faculty member at Princeton University from 1976 through 1984, before joining MIT in 1999. Dr. Constantine-Paton studies activity- dependent brain development, glutamate receptor regulation, and physiol- ogy of the developing visual system in animal models. She is interested in the biochemical, structural, or genetic programs that cause the developing brain to lose its plasticity or to compensate for genetic mutations or trauma as the brain matures, possibly leading to loss of learning and memory or to
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830 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY neurological or neuropsychiatric disease. Dr. Constantine-Paton earned her Ph.D. in 1976 from Cornell University. She has received a number of honors and awards, among them the Young Investigator Award from the Society of Neuroscience and a Merit Award from the National Eye Institute. She has served on numerous committees and councils. She has previously worked for the Institute of Medicine on panels that suggested new nutritional guidelines and explored the ethics and value of fetal tissue use. She has been a member of several grant review panels at the National Institutes of Health, including the National Advisory Eye Council and the Child Council Workgroup for the National Institute of Mental Health. Deborah J. del Junco, Ph.D., is the director of outcomes research at the Center for Translational Injury Research and senior epidemiologist at the Center for Clinical and Translational Sciences at the University of Texas Health Science Center-Houston (UTHealth-H). She is associate profes- sor in the Departments of Surgery and Pediatrics (UTHealth-H School of Medicine) and the Division of Epidemiology, Human Genetics and Envi- ronmental Sciences (UTHealth-H School of Public Health). Her research and teaching have focused on epidemiology methods, gene-environment, and other complex interactions among etiologic factors in chronic disease, records linkage, meta-analysis, reproductive health, autoimmune disease, and Rett syndrome. She is a Fellow of the American College of Epidemiol- ogy and has served as an executive editor of Epidemiologic Perspectives and Innovations. She has many publications in peer-reviewed journals and has served on a large number of review panels and advisory committees for the National Institutes of Health, Centers for Disease Control and Prevention, and Department of Defense. Dr. del Junco completed a fellowship in the Department of Epidemiology and Biostatistics at the Mayo Clinic in Roch- ester, Minnesota, in 1984 and received her Ph.D. in epidemiology from the University of Texas Houston Health Science Center in 1988. Betty A. Diamond, M.D., is head of the Center for Autoimmune and Mus- culoskeletal Disease at the Feinstein Institute for Medical Research. Her research has focused on the immune system and autoimmune diseases, with an interest in systemic lupus erythematosus. Dr. Diamond is a practicing rheumatologist and has received many honors, including the Outstanding Investigator Award from the American College of Rheumatology, the Lee Howley Award from the Arthritis Foundation, the Recognition Award from the National Association of M.D.-Ph.D. Programs, and election to the Institute of Medicine. She has served on the Scientific Council of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Board of Directors of the American College of Rheumatology, and is a past-president of the American Association of Immunologists. She has a
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831 APPENDIX F grant from Autism Speaks to study the effects of maternal autoantibodies on fetal development. Dr. Diamond earned her medical degree from Har- vard Medical School in 1973, and then completed a residency in internal medicine at Columbia Presbyterian Medical Center and a postdoctoral fel- lowship in immunology at the Albert Einstein College of Medicine. S. Claiborne Johnston, M.D., Ph.D., is Associate Vice Chancellor of Re- search, Director of the Clinical and Translational Science Institute, Profes- sor of Neurology and Epidemiology, and Director of the Stroke Service at the University of California, San Francisco. He is a practicing neurologist, and his research has focused on stroke treatment and prevention. In the past, he has had funding from both Sanofi and Novartis to study drugs used in the treatment of stroke. His current funding from NINDS oversees the POINT multicenter randomized trial of Clopidogrel versus placebo in patients taking aspirin after TIA or minor ischemic stroke. He is also PI of a large trial of platinum versus coated coils in treating intracranial aneurysms sponsored by Stryker. Dr. Johnston has authored over 250 pub- lications in scientific journals and has won several national awards for his research and teaching. He was a member of the California Health Disease and Stroke Prevention Advisory Council, which advises the Department of Health Services, and was co-director of Prevention Education Programs for the National Stroke Association. Dr. Johnston received his M.D. from Harvard Medical School and Ph.D. in epidemiology from the University of California, Berkeley School of Public Health. Anthony L. Komaroff, M.D., is the Steven P. Simcox, Patrick A. Clifford, and James H. Higby Professor of Medicine at Harvard Medical School, senior physician at Brigham and Women’s Hospital, and editor-in-chief of Harvard Health Publications. He was director of the Division of General Medicine and Primary Care at Brigham and Women’s Hospital for 15 years and is the founding editor of Journal Watch, a summary medical informa- tion newsletter for physicians published by the Massachusetts Medical Society. Dr. Komaroff practices internal medicine (primary care and con- sultative medicine). For 25 years, he has conducted research on chronic fa- tigue syndrome, including studies of the prevalence of the illness, symptom presentation, and functional capacity, as well as virologic, immunologic, and neurologic studies. He is the author of over 200 journal articles, several book chapters, and one book, and is a fellow of the American College of Physicians and of the American Association for the Advancement of Sci- ence. Dr. Komaroff received his M.D. from the University of Washington. B. Paige Lawrence, Ph.D., is associate professor of environmental medicine and microbiology and immunology at the University of Rochester School
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832 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY of Medicine and Dentistry. Dr. Lawrence’s research is focused on defining the cellular and molecular mechanisms by which environmental factors adversely affect the development and function of the immune system. This work includes the impact of acute exposure to environmental contaminants and pharmacological agents, as well as the consequences of prenatal (ma- ternal) exposures on immune function in the next generation. Her work has shown that an environment-sensing transcription factor may have a com- plex mediating effect in the body, and results have demonstrated impacts on immune system function, including inflammatory responses and fighting viral infections. Dr. Lawrence has numerous peer-reviewed publications and professional awards, and serves on the editorial board for several toxicol- ogy journals. She has also served as a member of a science advisory panel for the U.S. Environmental Protection Agency and provides service to vari- ous review committees for the National Institutes of Health. She received her Ph.D. in cell biology from Cornell University in 1993, and postdoctoral training in immunology and toxicology at Oregon State University. M. Louise Markert, M.D., Ph.D., is associate professor of pediatrics and immunology in the Division of Pediatric Allergy and Immunology at Duke University School of Medicine. Dr. Markert has pioneered the development of thymus transplantation for T cell reconstitution in infants born with complete DiGeorge anomaly. DiGeorge anomaly is a congenital disorder characterized by defects of the heart, parathyroid, and thymus. Complete DiGeorge anomaly is fatal because of the absence of functional thymus leading to profound primary immunodeficiency. In research protocols to date, 61 infants with complete DiGeorge anomaly have been transplanted with postnatal cultured human thymic epithelial tissue. Over 70 percent of these infants survive and have developed functional T cells. Dr. Markert graduated from Smith College with a B.A. in biochemistry and then com- pleted the M.D./Ph.D. program at Duke University. She received her Ph.D. in immunology, completed a 2-year pediatric residency at Duke, and then a 3-year fellowship in pediatric allergy and immunology. Dr. Markert joined the Duke faculty in 1987. She was program director of the Duke NIH- funded General Clinical Research Center from 1993 to 2004. From 1996 to 2004, she served on the American Board of Allergy and Immunology and was chair of the Board in 2002. Dr. Markert has published over 40 research articles plus invited chapters and reviews. Marc C. Patterson, M.D., is chair of the Division of Child and Adolescent Neurology and professor of neurology, pediatrics, and medical genetics at Mayo Clinic. Dr. Patterson is a child neurologist with special expertise in neurometabolic and neurogenetic disorders. His research has focused on neurometabolic disorders, with a particular focus on Niemann-Pick disease,
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833 APPENDIX F Type C, Gaucher disease, and congenital disorders of glycosylation. Dr. Patterson was born and educated in Australia, where he graduated from the University of Queensland, before training in medicine, pediatrics, and neurology at the Royal Brisbane, Royal Children’s, and Royal Women’s Hospitals in Brisbane. He completed further training in pediatrics and child neurology at Mayo Graduate School of Medicine, and a fellowship in neurometabolic diseases with Roscoe Brady at the National Institutes of Health. On completion of training, Dr. Patterson joined the staff of Mayo Clinic and faculty of Mayo Medical School, where he was associ- ate professor in the Departments of Neurology, Pediatric and Adolescent Medicine, and Medical Genetics. In 2001, he moved to New York and was professor of clinical neurology and pediatrics at Columbia University and director of pediatric neurology at the Neurologic Institute of New York and Children’s Hospital of New York–Presbyterian. In 2007, he returned to the Mayo Clinic. Hugh A. Sampson, M.D., is professor of pediatrics and immunology at the Mount Sinai School of Medicine. He is also director of the Jaffe Food Allergy Institute, dean for Translational Biomedical Sciences at the Mount Sinai Medical Center, and a practicing pediatric allergist. Dr. Sampson’s research has focused on food allergic disorders, including work on the immuno-pathogenic role of food hypersensitivity in atopic dermatitis, the pathogenesis of food-induced anaphylaxis, characterization of food- induced gastrointestinal hypersensitivities, and immunotherapeutic strate- gies for treating food allergies. He holds a patent for a potential treatment vaccine for peanut allergy. Dr. Sampson is the past president of the Ameri- can Academy of Allergy, Asthma, and Immunology and a member of the In- stitute of Medicine. He is a co-editor of Pediatric Allergy and Immunology and has served on the editorial board of the Journal of Allergy and Clinical Immunology, and Clinical and Experimental Allergy. Dr. Sampson received his medical degree from the State University of New York, then finished a residency in pediatrics at the Children’s Memorial Hospital, and completed a fellowship in allergy and immunology at Duke University. Pauline A. Thomas, M.D., is associate professor in the Department of Preventive Medicine and Community Health in the New Jersey Medical School, and associate professor in the School of Public Health at the Uni- versity of Medicine and Dentistry of New Jersey. She is Co-Director of the NJMS Preventive Medicine Residency, and is also a practicing pediatrician. Her research interests include pediatric HIV, public health practice and surveillance methodology, and health care delivery. She served as assistant commissioner for surveillance in the Division of Epidemiology at the New York City Department of Health and Mental Hygiene and director of the
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834 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY Health Department’s Office of AIDS Surveillance. Dr. Thomas received her medical degree from Yale University School of Medicine in 1977 and completed her residency in pediatrics at Strong Memorial Hospital of the University of Rochester, New York. Following residency she worked 2 years with the Centers for Disease Control and Prevention as an epidemic intel- ligence service officer. Leslie P. Weiner, M.D., is professor of neurology and molecular microbiol- ogy and immunology and holds the Richard Angus Grant, Sr., Chair in Neurology at the Keck School of Medicine of the University of Southern California (USC). Dr. Weiner earned his medical degree from the University of Cincinnati and completed his neurology residency at the Johns Hopkins Hospital. At Johns Hopkins, he also pursued a fellowship in neurology and epidemiology, focusing on viruses of the nervous system. He then completed a fellowship at the National Institutes of Health Laboratory of Slow Virus Infections. Dr. Weiner served as chair of the USC Department of Neurology for 25 years and he remains a practicing neurologist. Dr. Weiner’s research interests include a human T cell vaccine for the treatment of secondary pro- gressive multiple sclerosis (MS), gene therapy for MS, molecular mimicry, and, more recently, neural stem cells. He has written more than 200 papers and has received numerous honors. He served as an expert witness for a federal judge in cases regarding adverse effects of the swine flu vaccine in the 1970s.