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Aaron Seth Kesselheim, M.D.

TitleAssociate Professor of Medicine
InstitutionBrigham and Women's Hospital
DepartmentMedicine
AddressBrigham and Women's Hospital
Pharmacoepidemiology, Suite 3030
1620 Tremont St
Boston MA 02120
Phone617/732-5775
Fax617/732-7072
vCardDownload vCard (login for email)

 Overview 
 overview
Aaron S. Kesselheim, M.D., J.D., M.P.H., is an Associate 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. He graduated from Harvard College and received his postgraduate training at the University of Pennsylvania School of Medicine and Law School, and most recently at the Harvard School of Public Health. He is Board Certified in Internal Medicine, and serves as a primary care physician at the Phyllis Jen Center for Primary Care 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. He is a member of the New York State Bar and is a Patent Attorney.

Within the Division, Dr. Kesselheim leads the Program On Regulation, Therapeutics, And Law (PORTAL), an interdisciplinary research core focusing on intersections among prescription drugs and medical devices, patient health outcomes, and regulatory practices and the law. In 2013, Dr. Kesselheim was named a Greenwall Faculty Scholar in Bioethics by the Greenwall Foundation, which supports innovative empirical research in bioethics. Dr. Kesselheim’s work is also currently funded by the Agency for Healthcare Research and Quality and by a Robert Wood Johnson Investigator Award in Health Policy Research. In the past, he has received research support from the Edmond J. Safra Center for Ethics at Harvard University, Pew Charitable Trusts, and the Harvard Clinical and Translational Science Center.

Dr. Kesselheim has received wide recognition for his work. In 2012, he was named to the Perspectives Advisory Board of the New England Journal of Medicine. He has testified before Congress on pharmaceutical policy, medical device regulation, and modernizing clinical trials, and served as a consultant for the NIH, FDA, Institute of Medicine, USPTO, and numerous state government offices. He has been a visiting scholar at the Yale School of Medicine and School of Management. In 2010, he received the prestigious Alice S. Hersh New Investigator Award from AcademyHealth, the leading 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.

Dr. Kesselheim also serves as a faculty supervisor for the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and is a Research Associate in the Department of Health Policy and Management at the Harvard School of Public Health.

In the 2014-2015 academic year, he will be a Visiting Associate Professor of Law at Yale Law School, where he will teach Food and Drug Administration Law.


 Mentoring 
 completed student projects
FDA Premarket Approval Supplements and Medical Device Safety and Effectiveness
Summer, 03/01/13 - 12/21/13
Clinical and Regulatory Features of Drugs Not Initially Approved by the US Food and Drug Administration
Full Time/Year Long, 05/01/13 - 04/30/14
Technological innovations in medication packaging to improve patient adherence: a systematic review
Summer, 06/11/12 - 08/10/12
Clinical Equivalence of Generic and Brand-Name Drugs in Cardiovascular Disease: A Systematic Review and Meta-Analysis
Summer, 12/10/07 - 10/19/08
Promoting Medical Innovation: The Case of Coronary Artery Stents
Summer, 06/13/11 - 08/31/11

 ORNG Applications 
 Websites

 Bibliographic 
 selected publications
Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Faculty can login to make corrections and additions.
List All   |   Timeline
  1. Kesselheim AS, Choudhry NK, Avorn J. Burden of changes in generic pill appearance. Ann Intern Med. 2014 Dec 2; 161(11):840.
    View in: PubMed
  2. Xu S, Kesselheim AS. Medical innovation then and now: perspectives of innovators responsible for transformative drugs. J Law Med Ethics. 2014 Dec; 42(4):564-75.
    View in: PubMed
  3. Gagne JJ, Thompson L, O'Keefe K, Kesselheim AS. Innovative research methods for studying treatments for rare diseases: methodological review. BMJ. 2014; 349:g6802.
    View in: PubMed
  4. Alpern JD, Stauffer WM, Kesselheim AS. High-cost generic drugs--implications for patients and policymakers. N Engl J Med. 2014 Nov 13; 371(20):1859-62.
    View in: PubMed
  5. Wang B, Joffe S, Kesselheim AS. Chemotherapy parity laws: a remedy for high drug costs? JAMA Intern Med. 2014 Nov 1; 174(11):1721-2.
    View in: PubMed
  6. Sarpatwari A, Kesselheim AS, Malin BA, Gagne JJ, Schneeweiss S. Ensuring patient privacy in data sharing for postapproval research. N Engl J Med. 2014 Oct 23; 371(17):1644-9.
    View in: PubMed
  7. Yeh JS, Austad KE, Franklin JM, Chimonas S, Campbell EG, Avorn J, Kesselheim AS. Association of medical students' reports of interactions with the pharmaceutical and medical device industries and medical school policies and characteristics: a cross-sectional study. PLoS Med. 2014 Oct; 11(10):e1001743.
    View in: PubMed
  8. Kirschner NM, Sulmasy LS, Kesselheim AS. Health policy basics: the physician payment sunshine act and the open payments program. Ann Intern Med. 2014 Oct 7; 161(7):519-21.
    View in: PubMed
  9. Kesselheim AS, Tan YT, Darrow JJ, Avorn J. Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs. Health Aff (Millwood). 2014 Oct 1; 33(10):1770-8.
    View in: PubMed
  10. Checchi KD, Huybrechts KF, Avorn J, Kesselheim AS. Electronic medication packaging devices and medication adherence: a systematic review. JAMA. 2014 Sep 24; 312(12):1237-47.
    View in: PubMed
  11. Gagne JJ, Choudhry NK, Kesselheim AS, Polinski JM, Hutchins D, Matlin OS, Brennan TA, Avorn J, Shrank WH. Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study. Ann Intern Med. 2014 Sep 16; 161(6):400-7.
    View in: PubMed
  12. Kesselheim AS, Rajan PV. Regulating incremental innovation in medical devices. BMJ. 2014; 349:g5303.
    View in: PubMed
  13. Duke JD, Kesselheim AS. The Food and Drug Administration's Role in Promoting Consistent Labels for Generic Drugs. JAMA Intern Med. 2014 Aug 1; 174(8):1213-4.
    View in: PubMed
  14. Kesselheim AS, Gagne JJ. Introduction to a supplement on innovative approaches to studying health outcomes in rare diseases. J Gen Intern Med. 2014 Aug; 29 Suppl 3:709-11.
    View in: PubMed
  15. Austad KE, Avorn J, Franklin JM, Campbell EG, Kesselheim AS. Association of marketing interactions with medical trainees' knowledge about evidence-based prescribing: results from a national survey. JAMA Intern Med. 2014 Aug 1; 174(8):1283-90.
    View in: PubMed
  16. Cortez NG, Cohen IG, Kesselheim AS. FDA regulation of mobile health technologies. N Engl J Med. 2014 Jul 24; 371(4):372-9.
    View in: PubMed
  17. Kesselheim AS, Bykov K, Avorn J, Tong A, Doherty M, Choudhry NK. Burden of changes in pill appearance for patients receiving generic cardiovascular medications after myocardial infarction: cohort and nested case-control studies. Ann Intern Med. 2014 Jul 15; 161(2):96-103.
    View in: PubMed
  18. Darrow JJ, Avorn J, Kesselheim AS. New FDA breakthrough-drug category--implications for patients. N Engl J Med. 2014 Jul 3; 371(1):89-90.
    View in: PubMed
  19. Kesselheim AS, Darrow JJ. Drug development and FDA approval, 1938-2013. N Engl J Med. 2014 Jun 26; 370(26):e39.
    View in: PubMed
  20. Rome BN, Kramer DB, Kesselheim AS. Approval of High-Risk Medical Devices in the US: Implications for Clinical Cardiology. Curr Cardiol Rep. 2014 Jun; 16(6):489.
    View in: PubMed
  21. Larkin I, Ang D, Avorn J, Kesselheim AS. Restrictions on pharmaceutical detailing reduced off-label prescribing of antidepressants and antipsychotics in children. Health Aff (Millwood). 2014 Jun 1; 33(6):1014-23.
    View in: PubMed
  22. Hwang TJ, Carpenter D, Kesselheim AS. Target small firms for antibiotic innovation. Science. 2014 May 30; 344(6187):967-9.
    View in: PubMed
  23. Hwang TJ, Avorn J, Kesselheim AS. Life Cycle of Medical Product Rules Issued by the US Food and Drug Administration. J Health Polit Policy Law. 2014 Aug; 39(4):751-80.
    View in: PubMed
  24. Polinski JM, Kesselheim AS, Frolkis JP, Wescott P, Allen-Coleman C, Fischer MA. A matter of trust: patient barriers to primary medication adherence. Health Educ Res. 2014 Oct; 29(5):755-63.
    View in: PubMed
  25. Sarpatwari A, Avorn J, Kesselheim AS. Using a drug-safety tool to prevent competition. N Engl J Med. 2014 Apr 17; 370(16):1476-8.
    View in: PubMed
  26. Hwang TJ, Kesselheim AS, Bourgeois FT. Postmarketing trials and pediatric device approvals. Pediatrics. 2014 May; 133(5):e1197-202.
    View in: PubMed
  27. Darrow JJ, Avorn J, Kesselheim AS. New FDA breakthrough-drug category--implications for patients. N Engl J Med. 2014 Mar 27; 370(13):1252-8.
    View in: PubMed
  28. Treasure CL, Avorn J, Kesselheim AS. What is the public's right to access medical discoveries based on federally funded research? JAMA. 2014 Mar 5; 311(9):907-8.
    View in: PubMed
  29. Luo J, Kesselheim AS. Underrepresentation of older adults in cancer trials. JAMA. 2014 Mar 5; 311(9):965-6.
    View in: PubMed
  30. Gellad WF, Choi P, Mizah M, Good CB, Kesselheim AS. Assessing the chiral switch: approval and use of single-enantiomer drugs, 2001 to 2011. Am J Manag Care. 2014; 20(3):e90-7.
    View in: PubMed
  31. Kesselheim AS, Xu S, Avorn J. Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation. PLoS One. 2014; 9(2):e88664.
    View in: PubMed
  32. Hwang TJ, Avorn J, Carpenter D, Kesselheim AS. Quantifying The Food And Drug Administration's Rulemaking Delays Highlights The Need For Transparency. Health Aff (Millwood). 2014 Feb; 33(2):309-15.
    View in: PubMed
  33. Kesselheim AS, Shiu N. The evolving role of biomarker patents in personalized medicine. Clin Pharmacol Ther. 2014 Feb; 95(2):127-9.
    View in: PubMed
  34. Hwang TJ, Carpenter D, Kesselheim AS. Assessment of US pathway for approving medical devices for rare conditions. BMJ. 2014; 348:g217.
    View in: PubMed
  35. Rome BN, Kramer DB, Kesselheim AS. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012. JAMA. 2014 Jan 22-29; 311(4):385-91.
    View in: PubMed
  36. Kesselheim AS, Avorn J. New and unproved medical devices. BMJ. 2013; 347:f7413.
    View in: PubMed
  37. Shah AK, Warsh J, Kesselheim AS. The ethics of intellectual property rights in an era of globalization. J Law Med Ethics. 2013 Dec; 41(4):841-51.
    View in: PubMed
  38. Yeh JS, Kesselheim AS. Same song, different audience: pharmaceutical promotion targeting non-physician health care providers. PLoS Med. 2013 Nov; 10(11):e1001560.
    View in: PubMed
  39. Kesselheim AS, Gagne JJ. Strategies for postmarketing surveillance of drugs for rare diseases. Clin Pharmacol Ther. 2014 Mar; 95(3):265-8.
    View in: PubMed
  40. Wang B, Kesselheim AS. The Role of Direct-to-Consumer Pharmaceutical Advertising in Patient Consumerism. Virtual Mentor. 2013; 15(11):960-5.
    View in: PubMed
  41. Austad KE, Avorn J, Franklin JM, Kesselheim AS. Physician trainees' interactions with the pharmaceutical industry. J Gen Intern Med. 2013 Oct; 28(10):1267.
    View in: PubMed
  42. Kramer DB, Tan YT, Sato C, Kesselheim AS. Postmarket surveillance of medical devices: a comparison of strategies in the US, EU, Japan, and China. PLoS Med. 2013; 10(9):e1001519.
    View in: PubMed
  43. Kesselheim AS, Green MD, Avorn J. Who is now responsible for discovering and warning about adverse effects of generic drugs? JAMA. 2013 Sep 11; 310(10):1023-4.
    View in: PubMed
  44. Kramer DB, Kesselheim AS. The medical device excise tax--before it begins? N Engl J Med. 2013 Sep 5; 369(10):984-5.
    View in: PubMed
  45. Gagne JJ, Polinski JM, Kesselheim AS, Choudhry NK, Hutchins D, Matlin OS, Tong A, Shrank WH. Patterns and predictors of generic narrow therapeutic index drug use among older adults. J Am Geriatr Soc. 2013 Sep; 61(9):1586-91.
    View in: PubMed
  46. Ross JS, Kesselheim AS. Prescription-drug coupons--no such thing as a free lunch. N Engl J Med. 2013 Sep 26; 369(13):1188-9.
    View in: PubMed
  47. Wang B, Avorn J, Kesselheim AS. Clinical and regulatory features of drugs not initially approved by the FDA. Clin Pharmacol Ther. 2013 Dec; 94(6):670-7.
    View in: PubMed
  48. Austad KE, Avorn J, Franklin JM, Kowal MK, Campbell EG, Kesselheim AS. Erratum to: Changing Interactions Between Physician Trainees and the Pharmaceutical Industry: A National Survey. J Gen Intern Med. 2013 Aug; 28(8):1115-6.
    View in: PubMed
  49. Austad KE, Avorn J, Franklin JM, Kowal MK, Campbell EG, Kesselheim AS. Changing interactions between physician trainees and the pharmaceutical industry: a national survey. J Gen Intern Med. 2013 Aug; 28(8):1064-71.
    View in: PubMed
  50. Rajkumar R, Kesselheim AS. Balancing access and innovation: India's Supreme Court rules on imatinib. JAMA. 2013 Jul 17; 310(3):263-4.
    View in: PubMed
  51. Kesselheim AS, Cook-Deegan RM, Winickoff DE, Mello MM. Gene patenting--the Supreme Court finally speaks. N Engl J Med. 2013 Aug 29; 369(9):869-75.
    View in: PubMed
  52. Kesselheim AS. Rising health care costs and life-cycle management in the pharmaceutical market. PLoS Med. 2013; 10(6):e1001461.
    View in: PubMed
  53. Kesselheim AS, Wang B, Avorn J. Defining "innovativeness" in drug development: a systematic review. Clin Pharmacol Ther. 2013 Sep; 94(3):336-48.
    View in: PubMed
  54. Kesselheim AS, Avorn J. The most transformative drugs of the past 25 years: a survey of physicians. Nat Rev Drug Discov. 2013 Jun; 12(6):425-31.
    View in: PubMed
  55. Kesselheim AS, Robertson CT, Siri K, Batra P, Franklin JM. Distributions of industry payments to Massachusetts physicians. N Engl J Med. 2013 May 30; 368(22):2049-52.
    View in: PubMed
  56. Kesselheim AS, Franklin JM, Avorn J, Duke JD. Speaking the same language? International variations in the safety information accompanying top-selling prescription drugs. BMJ Qual Saf. 2013 Sep; 22(9):727-34.
    View in: PubMed
  57. Kramer DB, Kesselheim AS. The medical device excise tax--over before it begins? N Engl J Med. 2013 May 9; 368(19):1767-9.
    View in: PubMed
  58. Kesselheim AS. Drug company gifts to medical students: the hidden curriculum. BMJ. 2013; 346:f1113.
    View in: PubMed
  59. Kesselheim AS, Misono AS, Shrank WH, Greene JA, Doherty M, Avorn J, Choudhry NK. Variations in pill appearance of antiepileptic drugs and the risk of nonadherence. JAMA Intern Med. 2013 Feb 11; 173(3):202-8.
    View in: PubMed
  60. Kesselheim AS, Mello MM, Avorn J. FDA regulation of off-label drug promotion under attack. JAMA. 2013 Feb 6; 309(5):445-6.
    View in: PubMed
  61. Outterson K, Powers JH, Seoane-Vazquez E, Rodriguez-Monguio R, Kesselheim AS. Approval and withdrawal of new antibiotics and other antiinfectives in the U.S., 1980-2009. J Law Med Ethics. 2013; 41(3):688-96.
    View in: PubMed
  62. Kesselheim AS, Avorn J, Greene JA. Risk, responsibility, and generic drugs. N Engl J Med. 2012 Nov; 367(18):1679-81.
    View in: PubMed
  63. Xu S, Avorn J, Kesselheim AS. Origins of medical innovation: the case of coronary artery stents. Circ Cardiovasc Qual Outcomes. 2012 Nov; 5(6):743-9.
    View in: PubMed
  64. Kesselheim AS, Avorn J. Drug labels: a flawed source of data for studying orphan drug approvals. Clin Pharmacol Ther. 2012 Dec; 92(6):694; author reply 695.
    View in: PubMed
  65. Kramer DB, Kesselheim AS. User fees and beyond--the FDA Safety and Innovation Act of 2012. N Engl J Med. 2012 Oct 4; 367(14):1277-9.
    View in: PubMed
  66. Amin T, Kesselheim AS. Secondary patenting of branded pharmaceuticals: a case study of how patents on two HIV drugs could be extended for decades. Health Aff (Millwood). 2012 Oct; 31(10):2286-94.
    View in: PubMed
  67. Kesselheim AS, Avorn J. The Food and Drug Administration has the legal basis to restrict promotion of flawed comparative effectiveness research. Health Aff (Millwood). 2012 Oct; 31(10):2200-5.
    View in: PubMed
  68. Kesselheim AS, Robertson CT, Myers JA, Rose SL, Gillet V, Ross KM, Glynn RJ, Joffe S, Avorn J. A randomized study of how physicians interpret research funding disclosures. N Engl J Med. 2012 Sep 20; 367(12):1119-27.
    View in: PubMed
  69. Greene JA, Choudhry NK, Kesselheim AS, Brennan TA, Shrank W. Changes in direct-to-consumer pharmaceutical advertising following shifts from prescription-only to over-the-counter status. JAMA. 2012 Sep 12; 308(10):973-5.
    View in: PubMed
  70. Kesselheim AS, Wang B, Studdert DM, Avorn J. Conflict of interest reporting by authors involved in promotion of off-label drug use: an analysis of journal disclosures. PLoS Med. 2012; 9(8):e1001280.
    View in: PubMed
  71. Kesselheim AS. Ethical considerations in orphan drug approval and use. Clin Pharmacol Ther. 2012 Aug; 92(2):153-5.
    View in: PubMed
  72. Kramer DB, Xu S, Kesselheim AS. How does medical device regulation perform in the United States and the European union? A systematic review. PLoS Med. 2012; 9(7):e1001276.
    View in: PubMed
  73. Truog RD, Kesselheim AS, Joffe S. Research ethics. Paying patients for their tissue: the legacy of Henrietta Lacks. Science. 2012 Jul 6; 337(6090):37-8.
    View in: PubMed
  74. Kesselheim AS, Karlawish J. Biomarkers unbound--the Supreme Court's ruling on diagnostic-test patents. N Engl J Med. 2012 Jun 21; 366(25):2338-40.
    View in: PubMed
  75. Kesselheim AS, Myers JA, Solomon DH, Winkelmayer WC, Levin R, Avorn J. The prevalence and cost of unapproved uses of top-selling orphan drugs. PLoS One. 2012; 7(2):e31894.
    View in: PubMed
  76. Kramer DB, Xu S, Kesselheim AS. Regulation of medical devices in the United States and European Union. N Engl J Med. 2012 Mar 1; 366(9):848-55.
    View in: PubMed
  77. Kesselheim AS, Orentlicher D. Introduction: insights from a National Conference: "conflicts of interest in the practice of medicine". J Law Med Ethics. 2012; 40(3):436-40.
    View in: PubMed
  78. Robertson C, Rose S, Kesselheim AS. Effect of financial relationships on the behaviors of health care professionals: a review of the evidence. J Law Med Ethics. 2012; 40(3):452-66.
    View in: PubMed
  79. Cole LW, Kesselheim JC, Kesselheim AS. Ethical issues in new drug prescribing. J Bioeth Inq. 2012 Mar; 9(1):77-83.
    View in: PubMed
  80. Kesselheim AS, Darby D, Studdert DM, Glynn R, Levin R, Avorn J. False Claims Act prosecution did not deter off-label drug use in the case of neurontin. Health Aff (Millwood). 2011 Dec; 30(12):2318-27.
    View in: PubMed
  81. Kesselheim AS, Cresswell K, Phansalkar S, Bates DW, Sheikh A. Clinical decision support systems could be modified to reduce 'alert fatigue' while still minimizing the risk of litigation. Health Aff (Millwood). 2011 Dec; 30(12):2310-7.
    View in: PubMed
  82. Avorn J, Kesselheim AS. The NIH translational research center might trade public risk for private reward. Nat Med. 2011 Oct; 17(10):1176.
    View in: PubMed
  83. Kesselheim AS, Murtagh L, Mello MM. "Pay for delay" settlements of disputes over pharmaceutical patents. N Engl J Med. 2011 Oct 13; 365(15):1439-45.
    View in: PubMed
  84. Austad KE, Kesselheim AS. Conflict of interest disclosure in early education of medical students. JAMA. 2011 Sep 7; 306(9):991-2.
    View in: PubMed
  85. Kesselheim AS. An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequences. Milbank Q. 2011 Sep; 89(3):450-502.
    View in: PubMed
  86. Kesselheim AS, Rajkumar R. Who owns federally funded research? The Supreme court and the Bayh-Dole act. N Engl J Med. 2011 Sep 29; 365(13):1167-9.
    View in: PubMed
  87. Kesselheim AS. The backlash against bioequivalence and the interchangeability of brand-name and generic drugs. CMAJ. 2011 Sep 6; 183(12):1350-1.
    View in: PubMed
  88. Greene JA, Kesselheim AS. Why do the same drugs look different? Pills, trade dress, and public health. N Engl J Med. 2011 Jul 7; 365(1):83-9.
    View in: PubMed
  89. Kesselheim AS, Lee JL, Avorn J, Servi A, Shrank WH, Choudhry NK. Conflict of interest in oncology publications: a survey of disclosure policies and statements. Cancer. 2012 Jan 1; 118(1):188-95.
    View in: PubMed
  90. Carpenter D, Kesselheim AS, Joffe S. Reputation and precedent in the bevacizumab decision. N Engl J Med. 2011 Jul 14; 365(2):e3.
    View in: PubMed
  91. Kesselheim AS, Myers JA, Avorn J. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer. JAMA. 2011 Jun 8; 305(22):2320-6.
    View in: PubMed
  92. Austad KE, Avorn J, Kesselheim AS. Medical students' exposure to and attitudes about the pharmaceutical industry: a systematic review. PLoS Med. 2011 May; 8(5):e1001037.
    View in: PubMed
  93. Kesselheim A. Safety, supply, and suits--litigation and the vaccine industry. N Engl J Med. 2011 Apr 21; 364(16):1485-7.
    View in: PubMed
  94. Avorn J, Kesselheim A. A hemorrhage of off-label use. Ann Intern Med. 2011 Apr 19; 154(8):566-7.
    View in: PubMed
  95. Kesselheim AS, Mello MM, Studdert DM. Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints. PLoS Med. 2011 Apr; 8(4):e1000431.
    View in: PubMed
  96. Shrank WH, Liberman JN, Fischer MA, Avorn J, Kilabuk E, Chang A, Kesselheim AS, Brennan TA, Choudhry NK. The consequences of requesting "dispense as written". Am J Med. 2011 Apr; 124(4):309-17.
    View in: PubMed
  97. Kesselheim AS. Covert pharmaceutical promotion in free medical journals. CMAJ. 2011 Mar 22; 183(5):534-5.
    View in: PubMed
  98. Kramer DB, Kesselheim AS, Salberg L, Brock DW, Maisel WH. Ethical and legal views regarding deactivation of cardiac implantable electrical devices in patients with hypertrophic cardiomyopathy. Am J Cardiol. 2011 Apr 1; 107(7):1071-1075.e5.
    View in: PubMed
  99. Kesselheim AS, Austad KE. Residents: workers or students in the eyes of the law? N Engl J Med. 2011 Feb 24; 364(8):697-9.
    View in: PubMed
  100. Kesselheim AS. Off-label drug use and promotion: balancing public health goals and commercial speech. Am J Law Med. 2011; 37(2-3):225-57.
    View in: PubMed
  101. Polinski JM, Kesselheim AS. Where cost, medical necessity, and morality meet: should US government insurance programs pay for erectile dysfunction drugs? Clin Pharmacol Ther. 2011 Jan; 89(1):17-9.
    View in: PubMed
  102. Kesselheim AS, Outterson K. Improving antibiotic markets for long-term sustainability. Yale J Health Policy Law Ethics. 2011; 11(1):101-67.
    View in: PubMed
  103. Greene JA, Kesselheim AS. Pharmaceutical marketing and the new social media. N Engl J Med. 2010 Nov 25; 363(22):2087-9.
    View in: PubMed
  104. Cutler C, Kesselheim A, Gabardi S, Andersson BS, Carpenter P, Khoury HJ, Litzow M, Rowley SD, Lanum S, Leather H, Tina Shih YC, Gale RP, Wingard JR, Appelbaum FR, Anasetti C. Generic immunosuppressants in hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2011 Mar; 17(3):285-90.
    View in: PubMed
  105. Kesselheim AS. Using market-exclusivity incentives to promote pharmaceutical innovation. N Engl J Med. 2010 Nov 4; 363(19):1855-62.
    View in: PubMed
  106. Chokshi DA, Avorn J, Kesselheim AS. Designing comparative effectiveness research on prescription drugs: lessons from the clinical trial literature. Health Aff (Millwood). 2010 Oct; 29(10):1842-8.
    View in: PubMed
  107. Outterson K, Powers JH, Gould IM, Kesselheim AS. Questions about the 10 x '20 Initiative. Clin Infect Dis. 2010 Sep 15; 51(6):751-2; author reply 754-5.
    View in: PubMed
  108. Kesselheim AS, Outterson K. Fighting antibiotic resistance: marrying new financial incentives to meeting public health goals. Health Aff (Millwood). 2010 Sep; 29(9):1689-96.
    View in: PubMed
  109. Kramer DB, Kesselheim AS, Brock DW, Maisel WH. Ethical and legal views of physicians regarding deactivation of cardiac implantable electrical devices: a quantitative assessment. Heart Rhythm. 2010 Nov; 7(11):1537-42.
    View in: PubMed
  110. Kesselheim AS, Maisel WH. Managing financial and nonfinancial conflicts of interest in healthcare delivery. Am J Ther. 2010 Jul-Aug; 17(4):440-3.
    View in: PubMed
  111. Shrank WH, Choudhry NK, Agnew-Blais J, Federman AD, Liberman JN, Liu J, Kesselheim AS, Brookhart MA, Fischer MA. State generic substitution laws can lower drug outlays under Medicaid. Health Aff (Millwood). 2010 Jul; 29(7):1383-90.
    View in: PubMed
  112. Kesselheim AS. Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety. Clin Pharmacol Ther. 2010 Jun; 87(6):645-7.
    View in: PubMed
  113. Kesselheim AS, Studdert DM, Mello MM. Whistle-blowers' experiences in fraud litigation against pharmaceutical companies. N Engl J Med. 2010 May 13; 362(19):1832-9.
    View in: PubMed
  114. Kesselheim AS, November MT, Lifford KL, McElrath TF, Puopolo AL, Orav EJ, Studdert DM. Using malpractice claims to identify risk factors for neurological impairment among infants following non-reassuring fetal heart rate patterns during labour. J Eval Clin Pract. 2010 Jun; 16(3):476-83.
    View in: PubMed
  115. Kesselheim AS, Solomon DH. Incentives for drug development--the curious case of colchicine. N Engl J Med. 2010 Jun 3; 362(22):2045-7.
    View in: PubMed
  116. Kesselheim AS, Mello MM. Gene patenting--is the pendulum swinging back? N Engl J Med. 2010 May 20; 362(20):1855-8.
    View in: PubMed
  117. Kesselheim AS, Stedman MR, Bubrick EJ, Gagne JJ, Misono AS, Lee JL, Brookhart MA, Avorn J, Shrank WH. Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: a systematic review and meta-analysis. Drugs. 2010 Mar 26; 70(5):605-21.
    View in: PubMed
  118. Stedman MR, Curtin F, Elbourne DR, Kesselheim AS, Brookhart MA. Meta-analyses involving cross-over trials: methodological issues. Int J Epidemiol. 2011 Dec; 40(6):1732-4.
    View in: PubMed
  119. Kesselheim AS. The Supreme Court, process patents, and medical innovation. N Engl J Med. 2009 Dec 10; 361(24):2303-6.
    View in: PubMed
  120. Engelberg AB, Kesselheim AS, Avorn J. Balancing innovation, access, and profits--market exclusivity for biologics. N Engl J Med. 2009 Nov 12; 361(20):1917-9.
    View in: PubMed
  121. Amin T, Rajkumar R, Radhakrishnan P, Kesselheim AS. Expert review of drug patent applications: improving health in the developing world. Health Aff (Millwood). 2009 Sep-Oct; 28(5):w948-56.
    View in: PubMed
  122. Outterson K, Kesselheim AS. How Medicare could get better prices on prescription drugs. Health Aff (Millwood). 2009 Sep-Oct; 28(5):w832-41.
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  123. Kesselheim AS. Priority review vouchers: an inefficient and dangerous way to promote neglected-disease drug development. Clin Pharmacol Ther. 2009 Jun; 85(6):573-5.
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  124. Kesselheim AS, Studdert DM. The Supreme Court, preemption, and malpractice liability. N Engl J Med. 2009 Feb 5; 360(6):559-61.
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  125. Kesselheim AS, Avorn J. Using patent data to assess the value of pharmaceutical innovation. J Law Med Ethics. 2009; 37(2):176-83.
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  126. Kesselheim AS, Studdert DM. Professional oversight of physician expert witnesses: an analysis of complaints to the Professional Conduct Committee of the American Association of Neurological Surgeons, 1992-2006. Ann Surg. 2009 Jan; 249(1):168-72.
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  127. Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart MA, Choudhry NK, Shrank WH. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008 Dec 3; 300(21):2514-26.
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  128. Kesselheim AS. Drug development for neglected diseases - the trouble with FDA review vouchers. N Engl J Med. 2008 Nov 6; 359(19):1981-3.
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  129. Kesselheim AS, Studdert DM. Whistleblower-initiated enforcement actions against health care fraud and abuse in the United States, 1996 to 2005. Ann Intern Med. 2008 Sep 2; 149(5):342-9.
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  130. Kesselheim AS, Avorn J. Pharmaceutical promotion to physicians and First Amendment rights. N Engl J Med. 2008 Apr 17; 358(16):1727-32.
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  131. Kesselheim AS, Choudhry NK. The international pharmaceutical market as a source of low-cost prescription drugs for U.S. patients. Ann Intern Med. 2008 Apr 15; 148(8):614-9.
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  132. Chokshi DA, Kesselheim AS. Rethinking global access to vaccines. BMJ. 2008 Apr 5; 336(7647):750-3.
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  133. Dudzinski DM, Kesselheim AS. Scientific and legal viability of follow-on protein drugs. N Engl J Med. 2008 Feb 21; 358(8):843-9.
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  134. Kesselheim AS. Think globally, prescribe locally: how rational pharmaceutical policy in the U.S. can improve global access to essential medicines. Am J Law Med. 2008; 34(2-3):125-39.
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  135. Outterson K, Kesselheim AS. Market-based licensing for HPV vaccines in developing countries. Health Aff (Millwood). 2008 Jan-Feb; 27(1):130-9.
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  136. Kesselheim AS, Studdert DM. Role of professional organizations in regulating physician expert witness testimony. JAMA. 2007 Dec 26; 298(24):2907-9.
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  137. Shrank WH, Agnew-Blais J, Choudhry NK, Wolf MS, Kesselheim AS, Avorn J, Shekelle P. The variability and quality of medication container labels. Arch Intern Med. 2007 Sep 10; 167(16):1760-5.
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  138. Kesselheim AS. Intellectual property policy in the pharmaceutical sciences: the effect of inappropriate patents and market exclusivity extensions on the health care system. AAPS J. 2007; 9(3):E306-11.
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  139. Kesselheim AS and Mello MM. Confidentiality laws and secrecy in medical research: improving access to drug safety data. Health Affairs. 2007; 26(2):483-491.
  140. Kesselheim AS and Avorn J. The role of litigation in drug safety. Journal of the American Medical Association. 2007; 297(3):308-311.
  141. Kesselheim AS and Studdert DM. Author Reply: Characteristics of physicians who frequently act as expert witnesses in neurological birth injury litigation. Obstetrics & Gynecology. 2006; 108(6):1552-1553.
  142. Kesselheim AS, Mello MM. Medical process patents – monopolizing the delivery of health care. New England Journal of Medicine. 2006; 355(19):2036-2041.
  143. Kesselheim AS, Fischer MA, Avorn J. Extensions of intellectual property rights and delayed adoption of generic drugs: effects on Medicaid spending. Health Affairs. 2006; 25(6):1637-1647.
  144. Reese PP, Caplan AL, Kesselheim AS, Bloom RD. Creating a medical, ethical, and legal framework for complex living kidney donors. Clin J Am Soc Nephrol. 2006 Nov; 1(6):1148-53.
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  145. Kesselheim AS and Studdert DM. Characteristics of physicians who frequently act as expert witnesses in neurological birth injury litigation. Obstetrics & Gynecology. 2006; 108(2):273-279.
  146. Kesselheim AS, Fischer MA, Avorn J. The rise and fall of Natrecor for congestive heart failure: implications for drug policy. Health Affairs. 2006; 25(4):1095-1102.
  147. Kesselheim AS, Ferris TG, Studdert DM. Will physician-level measures of clinical performance be used in medical malpractice litigation? JAMA. 2006 Apr 19; 295(15):1831-4.
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  148. Kesselheim AS and Avorn J. Biomedical patents and the public’s health: is there a role for eminent domain?. Journal of the American Medical Association. 2006; 295(4):434-437.
  149. Rudnick MR, Kesselheim A, Goldfarb S. Contrast-induced nephropathy: how it develops, how to prevent it. Cleve Clin J Med. 2006 Jan; 73(1):75-80, 83-7.
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  150. Friedberg MA and Kesselheim AS. Establishing a medico-legal and health policy education curriculum for medical residents. Journal of General Internal Medicine. 2006; 21 suppl. 4:172.
  151. Kesselheim AS and Avorn J. Biotechnology products and university-based science. Journal of the American Medical Association. 2005; 293(23):2863.
  152. Kesselheim AS and Brennan TA. Overbilling vs. downcoding — the battle between physicians and insurers. New England Journal of Medicine. 2005; 352(9):855-857.
  153. Kesselheim AS and Avorn J. University-based science and biotechnology research: defining the boundaries of intellectual property. Journal of the American Medical Association. 2005; 293(7):850-854.
  154. Kesselheim AS, Brennan TA. The swinging pendulum: the Supreme Court reverses course on ERISA and managed care. Yale J Health Policy Law Ethics. 2005; 5(1):451-63.
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  155. Kesselheim AS. Patents and intellectual property in medicine. Legal Medicine. 2004; 207-213.
  156. Kesselheim AS. Perspectives: ode to a short white coat. Pharos. 2003; 66:35.
  157. Kesselheim AS. Privacy versus the public’s right to know: presidential health and the white house physician. Journal of Legal Medicine. 2002; 23(4):523-545.
  158. Kissick WL and Kesselheim AS. Presidential disability: the panel of physicians. Transactions & Studies of the College of Physicians of Philadelphia. 2001; 23:113-119.
  159. Kesselheim AS. Deception and presidential disability: an historical analysis. Trans Stud Coll Physicians Phila. 2001 Dec; 23:87-98.
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  160. Kesselheim AS. Ensuring quality end-of-life cancer care: an analysis of the current state of patient and family information about end-of-life care issues, its deficiencies, and recommendations for the future. Gelband H & Foley KM, eds. Excellent end-of-life care for cancer patients: a policy agenda for action and research. 2001; 132-152.
  161. Kesselheim AS. What’s the appeal? Trying to control managed care medical necessity decisionmaking through a system of external appeals. University of Pennsylvania Law Review. 2001; 149(3):873-920.
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