Aaron Seth Kesselheim

Aaron Seth Kesselheim, MD, JD, MPH

Professor of Medicine
Member, HMS Center for Bioethics

Aaron S. Kesselheim, MD, JD, MPH, is a Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital. Within the Division, Aaron created and leads the Program On Regulation, Therapeutics, And Law (PORTAL, www.PORTALresearch.org), an interdisciplinary research core focusing on intersections among prescription drugs and medical devices, patient health outcomes, and regulatory practices and the law. PORTAL is now among the largest, independent academic centers focusing on these issues in the country (Twitter: @PORTAL_research, @akesselheim). Dr. Kesselheim received his medical and legal training at the University of Pennsylvania and his M.P.H. at the Harvard School of Public Health. Author of over 450 publications in the peer-reviewed medical and health policy literatures, Aaron has testified before Congress on pharmaceutical policy, medical device regulation, generic drugs, and modernizing clinical trials, is a member of the FDA Peripheral and Central Nervous System Advisory Committee, and served on a National Academies of Science, Engineering and Medicine consensus committees on addressing the opioid epidemic and bioidentical hormone replacement. At the HMS Center for Bioethics, he co-teaches a course on health policy, law, and bioethics and organizes the monthly policy and ethics consortium.

Publications View
Correction to: Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence.
Authors: Authors: Gagne JJ, Polinski JM, Jiang W, Dutcher SK, Xie J, Lii J, Fulchino LA, Kesselheim AS.
Drugs
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Studying new antibiotics for multidrug resistant infections: are today's patients paying for unproved future benefits?
Authors: Authors: Powers JH, Evans SR, Kesselheim AS.
BMJ
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Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov.
Authors: Authors: Bothwell LE, Avorn J, Khan NF, Kesselheim AS.
BMJ Open
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The Regulatory Accountability Act of 2017 - Implications for FDA Regulation and Public Health.
Authors: Authors: Darrow JJ, Fuse Brown EC, Kesselheim AS.
N Engl J Med
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Research ethics for emerging trial designs: does equipoise need to adapt?
Authors: Authors: Hey SP, Weijer C, Taljaard M, Kesselheim AS.
BMJ
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Massachusetts' Proposed Medicaid Reforms - Cheaper Drugs and Better Coverage?
Authors: Authors: Sommers BD, Kesselheim AS.
N Engl J Med
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Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis.
Authors: Authors: Sinha MS, Freifeld CC, Brownstein JS, Donneyong MM, Rausch P, Lappin BM, Zhou EH, Dal Pan GJ, Pawar AM, Hwang TJ, Avorn J, Kesselheim AS.
JMIR Public Health Surveill
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Use of Health Care Databases to Support Supplemental Indications of Approved Medications.
Authors: Authors: Fralick M, Kesselheim AS, Avorn J, Schneeweiss S.
JAMA Intern Med
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Pharmaceutical Advertising in Medical Journals: Revisiting a Long-Standing Relationship.
Authors: Authors: Sinha MS, Kesselheim AS, Darrow JJ.
Chest
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Prices of Generic Drugs Associated with Numbers of Manufacturers.
Authors: Authors: Dave CV, Hartzema A, Kesselheim AS.
N Engl J Med
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Address: 
Brigham and Women's Hospital
Boston, MA 02120