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
Secondary patenting of branded pharmaceuticals: a case study of how patents on two HIV drugs could be extended for decades.
Authors: Authors: Amin T, Kesselheim AS.
Health Aff (Millwood)
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The Food and Drug Administration has the legal basis to restrict promotion of flawed comparative effectiveness research.
Authors: Authors: Kesselheim AS, Avorn J.
Health Aff (Millwood)
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A randomized study of how physicians interpret research funding disclosures.
Authors: Authors: Kesselheim AS, Robertson CT, Myers JA, Rose SL, Gillet V, Ross KM, Glynn RJ, Joffe S, Avorn J.
N Engl J Med
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Changes in direct-to-consumer pharmaceutical advertising following shifts from prescription-only to over-the-counter status.
Authors: Authors: Greene JA, Choudhry NK, Kesselheim AS, Brennan TA, Shrank W.
JAMA
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Ethical considerations in orphan drug approval and use.
Authors: Authors: Kesselheim AS.
Clin Pharmacol Ther
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Research ethics. Paying patients for their tissue: the legacy of Henrietta Lacks.
Authors: Authors: Truog RD, Kesselheim AS, Joffe S.
Science
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Biomarkers unbound--the Supreme Court's ruling on diagnostic-test patents.
Authors: Authors: Kesselheim AS, Karlawish J.
N Engl J Med
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Ethical issues in new drug prescribing.
Authors: Authors: Cole LW, Kesselheim JC, Kesselheim AS.
J Bioeth Inq
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Regulation of medical devices in the United States and European Union.
Authors: Authors: Kramer DB, Xu S, Kesselheim AS.
N Engl J Med
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How does medical device regulation perform in the United States and the European union? A systematic review.
Authors: Authors: Kramer DB, Xu S, Kesselheim AS.
PLoS Med
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Address: 
Brigham and Women's Hospital
Boston, MA 02120