Brigham and Women’s Hospital, Division of Pharmacoepidemiology and Pharmacoeconomics

Aaron S. Kesselheim, M.D., J.D., M.P.H.
Fellowship Site Director
Assistant Professor of Medicine, Harvard Medical School

Dr. Kesselheim is Board Certified in Internal Medicine, serves as a primary care physician, and attends on the general medicine inpatient service at BWH. His research focuses on the effects of intellectual property laws and regulatory policies on pharmaceutical development, the drug approval process, and the costs, availability, and use of prescription drugs both domestically and in resource-poor settings. He has also investigated how other issues at the intersection of law and public health can affect the health care system, including health care fraud, expert testimony in malpractice cases, and insurance reimbursement practices. Dr. Kesselheim’s research has been supported by the Agency for Healthcare Research and Quality, the Edmond J. Safra Center for Ethics at Harvard University, and the Robert Wood Johnson Investigator Award in Health Policy Research. He has testified before Congress on pharmaceutical policy issues and served as a consultant for the NIH, FDA, Institute of Medicine, USPTO, and numerous state government offices. In 2010, he received the Alice S. Hersh New Investigator Award from AcademyHealth, the main professional organization for health services/policy research. The Hersh award is given annually to an outstanding health services researcher under age 40 in the US. He is a member of the New York State Bar and is a Patent Attorney.

Jerry Avorn, M.D.
Fellowship Site Director
Division Chief, Pharmacoepidemiology and Pharmacoeconomics
Professor of Medicine, Harvard Medical School

Dr. Jerry Avorn is internist, geriatrician, and drug epidemiologist, and he studies the intended and adverse effects of drugs, physician prescribing practices, and medication policy. His major areas of research include: the scientific, policy, and social factors that shape physicians’ drug choices; medication compliance by patients; the identification and prevention of adverse drug effects; programs to improve the appropriateness of prescribing and drug taking; and pharmaceutical cost-effectiveness analysis. Dr. Avorn pioneered the “academic detailing” approach in which evidence-based information about drugs is provided to doctors through educational outreach programs run by non-commercial sponsors; such programs are now in widespread use throughout the U.S., Canada, Australia, Europe, and the developing world. Dr. Avorn has served on several national and international panels as an expert on the determinants and consequences of medication use, and is a past President of the International Society of Pharmaco-Epidemiology. Dr. Avorn is the author of over 400 papers in the medical literature on medication use and its outcomes, and is one of the most highly-cited researchers working in the area of medicine and the social sciences. His book, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs, was published by Knopf in 2005.

Sebastian Schneeweiss, M.D., Sc.D.
Fellowship Site Director
Division Vice-Chief, Pharmacoepidemiology and Pharmacoeconomics
Associate Professor of Medicine and Epidemiology, Harvard Medical School

Dr. Schneeweiss’s research is funded by multiple NIH grants and focuses on the comparative effectiveness and safety of biopharmaceuticals and analytic methods to improve the validity of epidemiologic studies using complex healthcare databases. He is Principal Investigator of the BWH DEcIDE Research Center on Comparative Effectiveness Research and the DEcIDE Methods Center both funded by AHRQ and Director of the Harvard-Brigham Drug Safety Research Center funded by FDA/CDER. Dr. Schneeweiss is Past President of the International Society for Pharmacoepidemiology and is Fellow of the American College of Epidemiology, the American College of Clinical Pharmacology, and the International Society for Pharmacoepidemiology. He is voting consultant to the FDA Drug Safety and Risk Management Advisory Committee and member of the Methods Committee of the Patient Centered Outcomes Research Institute. He received his medical training at the University of Munich Medical School and his doctoral degree in Pharmacoepidemiology from Harvard.

• Impact of drugs and dialysis on health and survival in end-stage renal disease and chronic kidney disease and identification of novel physiological pathways through which these effects may be mediated
• Impact of pharmacotherapy on the incidence and progression of kidney injury

• Impact of medication costs and drug benefit design on the use of and adherence to medications for common chronic conditions, such as coronary artery disease, hyperlipidemia and diabetes.

• Factors that influence medication use and outcomes by clinicians and patients
• Appropriate use of medications, drug evaluation, and assessment of complications of drug therapy.

• Methods for generating post-marketing comparative safety and effectiveness evidence for new medical products.

• Design and analysis of studies of risk factors and treatments for chronic diseases
• Designing, monitoring, and analyzing data from large-scale randomized trials, prospective cohort studies, and case-control studies
• Accounting for missing data, analysis of clustered data, and approaches to identify and adjust for selection bias

• History of essential medications in global health, medication nonadherence, access to generic pharmaceuticals, and the historical development and impact of pharmaceutical marketing, advertising, and salesmanship.

• Assessment of adverse outcomes associated with psychotropic medication use in different populations and settings, including elderly nursing home patients and pregnant women
• Exploring how variation in medication prescribing at the level of the physician or institution can be used to improve confounding control in observational studies in the area of psychiatry

• Comparative safety and effectiveness of medications for the rheumatic diseases, health services/outcome research in rheumatology

• Developing and applying statistical methods for comparative effectiveness and adverse effects of drugs, the consequences of drug policy, and the prevention of human error in medication use
• Causal inference and Bayesian and hierarchical modeling

• Management and treatment of chronic disease, patient and physician education, and the impact of health interventions and health policy changes on elderly populations
• Pharmaceutical use and policy related to government health programs

• Methods development and applications of instrumental variables in pharmacoepidemiology
• Computer science, large database systems, and systems performance, including use of computer science techniques in epidemiology, with particular focus on database integration, preservation of privacy, and epidemiolgic analyses that span cohorts and databases.

• Regulatory drug safety issues, use of health insurance claims databases as platforms for pharmacoepidemiology
• Propensity scores and related methods that seek to mitigate confounding by collapsing covariates

• Indicators of quality prescribing, patterns of medication use for osteoporosis, quality improvement in osteoporosis care, and cardiovascular disease in patients with rheumatoid arthritis
• Medication use and comparative benefits and risks of NSAIDs and drugs for osteoporosis

Denotes faculty who have graduated from the Fellowship Program

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