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profileAaron 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)

Collapse Biography 
Collapse awards and honors
2010Alice Hersh New Investigator Award
2014Chair's Research Award
2015 - 2016Young Mentor Award
2016Research Leadership Award

Collapse Overview 
Collapse 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 FDA, Laura and John Arnold Foundation, 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, AHRQ, 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, Johns Hopkins Medical School, and Memorial Sloan Kettering Cancer Center.

Dr. Kesselheim also serves as a core faculty member in the Harvard Medical School Center for Bioethics, a 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 Center for Bioethics, he co-teaches a course titled "Health Law, Policy, and Bioethics" for masters-level students each spring.

In 2014-2015 and again in 2016-2017, he has been a Visiting Associate Professor of Law at Yale Law School, where he teaches Food and Drug Administration Law.


Collapse Mentoring 
Collapse 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

Collapse ORNG Applications 
Collapse Websites

Collapse Bibliographic 
Collapse 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. Hey SP, Kesselheim AS. The FDA, Juno Therapeutics, and the ethical imperative of transparency. BMJ. 2016; 354:i4435. PMID: 27526698.
    View in: PubMed
  2. Yeh JS, Sarpatwari A, Kesselheim AS. Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels. Drug Saf. 2016 Aug; 39(8):709-14. PMID: 27000800.
    View in: PubMed
  3. Hey SP, Kesselheim AS. BIOMEDICAL RESEARCH. Countering imprecision in precision medicine. Science. 2016 Jul 29; 353(6298):448-9. PMID: 27471295.
    View in: PubMed
  4. Luo J, Kesselheim AS. Protecting Pharmaceutical Patents and Test Data: How the Trans-Pacific Partnership Agreement Could Affect Access to Medicines in the US and Abroad. AMA J Ethics. 2016; 18(7):727-35. PMID: 27437823.
    View in: PubMed
  5. Hwang TJ, Sokolov E, Franklin JM, Kesselheim AS. Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. BMJ. 2016; 353:i3323. PMID: 27352914.
    View in: PubMed
  6. Sarpatwari A, Kesselheim AS. Navigating the Dermatological Drug Cost Curve. JAMA. 2016 Jun 28; 315(24):2724-5. PMID: 27367767.
    View in: PubMed
  7. Sarpatwari A, Avorn J, Kesselheim AS. State Initiatives to Control Medication Costs--Can Transparency Legislation Help? N Engl J Med. 2016 Jun 16; 374(24):2301-4. PMID: 27305189.
    View in: PubMed
  8. Engelberg AB, Kesselheim AS. Use the Bayh-Dole Act to lower drug prices for government healthcare programs. Nat Med. 2016 Jun 7; 22(6):576. PMID: 27270771.
    View in: PubMed
  9. Yeh JS, Franklin JM, Avorn J, Landon J, Kesselheim AS. Association of Industry Payments to Physicians With the Prescribing of Brand-name Statins in Massachusetts. JAMA Intern Med. 2016 Jun 1; 176(6):763-8. PMID: 27159336.
    View in: PubMed
  10. Kesselheim AS, Gagne JJ, Eddings W, Franklin JM, Ross KM, Fulchino LA, Campbell EG. Prevalence and Predictors of Generic Drug Skepticism Among Physicians: Results of a National Survey. JAMA Intern Med. 2016 Jun 1; 176(6):845-7. PMID: 27158897.
    View in: PubMed
  11. Treasure CL, Kesselheim AS. How Patent Troll Legislation Can Increase Timely Access to Generic Drugs. JAMA Intern Med. 2016 Jun 1; 176(6):729-30. PMID: 27183456.
    View in: PubMed
  12. Caplan ES, Kesselheim AS. Anti-VEGF therapy in ophthalmology: a qualitative analysis of transformative drug development. Drug Discov Today. 2016 Jun; 21(6):1019-26. PMID: 27167328.
    View in: PubMed
  13. Kim SC, Choi NK, Lee J, Kwon KE, Eddings W, Sung YK, Ji Song H, Kesselheim AS, Solomon DH. Brief Report: Utilization of the First Biosimilar Infliximab Since Its Approval in South Korea. Arthritis Rheumatol. 2016 May; 68(5):1076-9. PMID: 26662931.
    View in: PubMed
  14. Kapczynski A, Kesselheim AS. 'Government Patent Use': A Legal Approach To Reducing Drug Spending. Health Aff (Millwood). 2016 May 1; 35(5):791-7. PMID: 27140984.
    View in: PubMed
  15. Rathi VK, Kesselheim AS, Ross JS. The US Food and Drug Administration 515 Program Initiative: Addressing the Evidence Gap for Widely Used, High-Risk Cardiovascular Devices? JAMA Cardiol. 2016 May 1; 1(2):117-8. PMID: 27437879.
    View in: PubMed
  16. Gagne JJ, Polinski JM, Jiang W, Dutcher SK, Xie J, Lii J, Fulchino LA, Kesselheim AS. Switch-backs associated with generic drugs approved using product-specific determinations of therapeutic equivalence. Pharmacoepidemiol Drug Saf. 2016 Aug; 25(8):944-52. PMID: 27102378.
    View in: PubMed
  17. Sarpatwari A, Kesselheim AS. Efficacy of the Priority Review Voucher Program. JAMA. 2016 Apr 19; 315(15):1660-1. PMID: 27092839.
    View in: PubMed
  18. Kesselheim AS, Woloshin S, Eddings W, Franklin JM, Ross KM, Schwartz LM. Physicians' Knowledge About FDA Approval Standards and Perceptions of the "Breakthrough Therapy" Designation. JAMA. 2016 Apr 12; 315(14):1516-8. PMID: 27115269.
    View in: PubMed
  19. Wang B, Franklin JM, Eddings W, Landon J, Kesselheim AS. Did FDA Decisionmaking Affect Anti-Psychotic Drug Prescribing in Children?: A Time-Trend Analysis. PLoS One. 2016; 11(3):e0152195. PMID: 27032095.
    View in: PubMed
  20. Hey SP, Kesselheim AS. An Uninformative Truth: The Logic of Amarin's Off-Label Promotion. PLoS Med. 2016 Mar; 13(3):e1001978. PMID: 26978686.
    View in: PubMed
  21. Wang B, Kesselheim AS. Promoting Therapeutic Innovation: What Do We Do About Drug-Device Combinations? JAMA. 2016 Mar 1; 315(9):857-8. PMID: 26934246.
    View in: PubMed
  22. Luo J, Avorn J, Kesselheim AS. Inaccurate Reporting of Insulin Reimbursement-Reply. JAMA Intern Med. 2016 Mar 1; 176(3):408-9. PMID: 26954041.
    View in: PubMed
  23. Kesselheim AS, Gagne JJ, Franklin JM, Eddings W, Fulchino LA, Avorn J, Campbell EG. Variations in Patients' Perceptions and Use of Generic Drugs: Results of a National Survey. J Gen Intern Med. 2016 Jun; 31(6):609-14. PMID: 26883524.
    View in: PubMed
  24. Sarpatwari A, Kesselheim AS. The Case for Reforming Drug Naming: Should Brand Name Trademark Protections Expire upon Generic Entry? PLoS Med. 2016 Feb; 13(2):e1001955. PMID: 26859662.
    View in: PubMed
  25. Luo J, Kesselheim AS. Insulin patents and market exclusivities: unresolved issues - Authors' reply. Lancet Diabetes Endocrinol. 2016 Feb; 4(2):98-9. PMID: 26825232.
    View in: PubMed
  26. Hwang TJ, Kesselheim AS. Vaccine Pipeline Has Grown During The Past Two Decades With More Early-Stage Trials From Small And Medium-Size Companies. Health Aff (Millwood). 2016 Feb 1; 35(2):219-26. PMID: 26858373.
    View in: PubMed
  27. Podolsky SH, Kesselheim AS. Regulating Homeopathic Products - A Century of Dilute Interest. N Engl J Med. 2016 Jan 21; 374(3):201-3. PMID: 26789866.
    View in: PubMed
  28. Kesselheim AS, Hwang TJ. Breakthrough Medical Devices and the 21st Century Cures Act. Ann Intern Med. 2016 Apr 5; 164(7):500-2. PMID: 26785350.
    View in: PubMed
  29. Yeh JS, Austad KE, Franklin JM, Chimonas S, Campbell EG, Avorn J, Kesselheim AS. Medical Schools' Industry Interaction Policies Not Associated With Trainees' Self-Reported Behavior as Residents: Results of a National Survey. J Grad Med Educ. 2015 Dec; 7(4):595-602. PMID: 26692972.
    View in: PubMed
  30. Kesselheim AS, Sinha MS, Joffe S. Physicians and Insider Trading. JAMA Intern Med. 2015 Dec 1; 175(12):1955-9. PMID: 26457747.
    View in: PubMed
  31. Treasure CL, Avorn J, Kesselheim AS. Do March-In Rights Ensure Access to Medical Products Arising From Federally Funded Research? A Qualitative Study. Milbank Q. 2015 Dec; 93(4):761-87. PMID: 26626985.
    View in: PubMed
  32. Luo J, Kesselheim AS. Cost-effectiveness of Statin Therapy for ASCVD. JAMA. 2015 Nov 24; 314(20):2191. PMID: 26599189.
    View in: PubMed
  33. Kesselheim AS, Hwang TJ, Franklin JM. Two decades of new drug development for central nervous system disorders. Nat Rev Drug Discov. 2015 Dec; 14(12):815-6. PMID: 26585536.
    View in: PubMed
  34. Luo J, Sarpatwari A, Kesselheim AS. Regulatory Solutions to the Problem of High Generic Drug Costs. Open Forum Infect Dis. 2015 Dec; 2(4):ofv179. PMID: 26693494.
    View in: PubMed
  35. Kesselheim AS, Maggs LR, Sarpatwari A. Experience With the Priority Review Voucher Program for Drug Development. JAMA. 2015 Oct 27; 314(16):1687-8. PMID: 26414802.
    View in: PubMed
  36. Kesselheim AS, Avorn J. The 21st Century Cures Act. N Engl J Med. 2015 Oct 22; 373(17):1679-80. PMID: 26488710.
    View in: PubMed
  37. Luo J, Kesselheim AS. The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines. JAMA. 2015 Oct 20; 314(15):1563-4. PMID: 26291894.
    View in: PubMed
  38. Sarpatwari A, Kesselheim AS. The 21st century cures act: Opportunities and challenges. Clin Pharmacol Ther. 2015 Dec; 98(6):575-7. PMID: 26264909.
    View in: PubMed
  39. Luo J, Kesselheim AS. Evolution of insulin patents and market exclusivities in the USA. Lancet Diabetes Endocrinol. 2015 Nov; 3(11):835-7. PMID: 26453281.
    View in: PubMed
  40. Kesselheim AS, Gagne JJ. Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness. Drug Saf. 2015 Oct; 38(10):849-53. PMID: 26105011.
    View in: PubMed
  41. Luo J, Avorn J, Kesselheim AS. Trends in Medicaid Reimbursements for Insulin From 1991 Through 2014. JAMA Intern Med. 2015 Oct 1; 175(10):1681-6. PMID: 26301721.
    View in: PubMed
  42. Kesselheim AS, Wang B, Franklin JM, Darrow JJ. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study. BMJ. 2015; 351:h4633. PMID: 26400751; PMCID: PMC4580726.
  43. Wang B, Kesselheim AS. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review. BMJ. 2015; 351:h4679. PMID: 26400844; PMCID: PMC4580725.
  44. Ross JS, Kesselheim AS. FDA Policy and Cardiovascular Medicine. Circulation. 2015 Sep 22; 132(12):1136-45. PMID: 26391294; PMCID: PMC4586041 [Available on 09/22/16].
  45. Gagne JJ, Kesselheim AS, Choudhry NK, Polinski JM, Hutchins D, Matlin OS, Brennan TA, Avorn J, Shrank WH. Comparative effectiveness of generic versus brand-name antiepileptic medications. Epilepsy Behav. 2015 Nov; 52(Pt A):14-8. PMID: 26386779.
    View in: PubMed
  46. Avorn J, Sarpatwari A, Kesselheim AS. Forbidden and Permitted Statements about Medications--Loosening the Rules. N Engl J Med. 2015 Sep 3; 373(10):967-73. PMID: 26332553.
    View in: PubMed
  47. Kesselheim AS, Campbell EG, Schneeweiss S, Rausch P, Lappin BM, Zhou EH, Seeger JD, Brownstein JS, Woloshin S, Schwartz LM, Toomey T, Dal Pan GJ, Avorn J. Erratum to: Methodological Approaches to Evaluate the Impact of FDA Drug Safety Communications. Drug Saf. 2015 Sep; 38(9):845. PMID: 26201399.
    View in: PubMed
  48. Sharfstein JM, Kesselheim AS. The Safety of Prescription Drugs. JAMA. 2015 Jul 21; 314(3):233-4. PMID: 26197182.
    View in: PubMed
  49. Avorn J, Kesselheim AS. The 21st Century Cures Act--Will It Take Us Back in Time? N Engl J Med. 2015 Jun 25; 372(26):2473-5. PMID: 26039522.
    View in: PubMed
  50. Kesselheim AS, Campbell EG, Schneeweiss S, Rausch P, Lappin BM, Zhou EH, Seeger JD, Brownstein JS, Woloshin S, Schwartz LM, Toomey T, Dal Pan GJ, Avorn J. Methodological approaches to evaluate the impact of FDA drug safety communications. Drug Saf. 2015 Jun; 38(6):565-75. PMID: 25968811.
    View in: PubMed
  51. Hwang TJ, Powers JH, Carpenter D, Kesselheim AS. Accelerating innovation in rapid diagnostics and targeted antibacterials. Nat Biotechnol. 2015 Jun; 33(6):589-90. PMID: 26057972.
    View in: PubMed
  52. Sarpatwari A, Avorn J, Kesselheim AS. Progress and Hurdles for Follow-on Biologics. N Engl J Med. 2015 Jun 18; 372(25):2380-2. PMID: 25946143.
    View in: PubMed
  53. Hwang TJ, Lehmann LS, Kesselheim AS. Precision medicine and the FDA's draft guidance on laboratory-developed tests. Nat Biotechnol. 2015 May; 33(5):449-51. PMID: 25965745.
    View in: PubMed
  54. Bateman BT, Kesselheim AS. Propofol as a transformative drug in anesthesia: insights from key early investigators. Drug Discov Today. 2015 Aug; 20(8):1012-7. PMID: 25936833.
    View in: PubMed
  55. Sarpatwari A, Darrow JJ, Kesselheim AS. Expanded access to investigational drugs. N Engl J Med. 2015 Apr 9; 372(15):1473-4. PMID: 25853762.
    View in: PubMed
  56. Kesselheim AS, Franklin JM, Kim SC, Seeger JD, Solomon DH. Reductions in Use of Colchicine after FDA Enforcement of Market Exclusivity in a Commercially Insured Population. J Gen Intern Med. 2015 Nov; 30(11):1633-8. PMID: 25855479; PMCID: PMC4617917 [Available on 11/01/16].
  57. Wang B, Liu J, Kesselheim AS. Variations in time of market exclusivity among top-selling prescription drugs in the United States. JAMA Intern Med. 2015 Apr; 175(4):635-7. PMID: 25664700.
    View in: PubMed
  58. Kesselheim AS, Polinski JM, Fulchino LA, Isaman DL, Gagne JJ. Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes. Drugs. 2015 Apr; 75(6):633-50. PMID: 25822610.
    View in: PubMed
  59. Sarpatwari A, Choudhry NK, Avorn J, Kesselheim AS. Paying physicians to prescribe generic drugs and follow-on biologics in the United States. PLoS Med. 2015 Mar; 12(3):e1001802. PMID: 25781468; PMCID: PMC4363899.
  60. Kramer DB, Kesselheim AS. The Watchman saga--closure at last? N Engl J Med. 2015 Mar 12; 372(11):994-5. PMID: 25760353; PMCID: PMC4394200.
  61. Kesselheim AS, Connolly J, Rogers J, Avorn J. Mandatory disclaimers on dietary supplements do not reliably communicate the intended issues. Health Aff (Millwood). 2015 Mar; 34(3):438-46. PMID: 25732494.
    View in: PubMed
  62. Hwang TJ, Carpenter D, Kesselheim AS. Paying for innovation: reimbursement incentives for antibiotics. Sci Transl Med. 2015 Feb 25; 7(276):276fs9. PMID: 25717095.
    View in: PubMed
  63. Kesselheim AS, Alpern JD, Stauffer WM. High-cost generic drugs--implications for patients and policymakers. N Engl J Med. 2015 Feb 12; 372(7):686. PMID: 25671269.
    View in: PubMed
  64. Kesselheim AS, Tan YT, Avorn J. The roles of academia, rare diseases, and repurposing in the development of the most transformative drugs. Health Aff (Millwood). 2015 Feb; 34(2):286-93. PMID: 25646109.
    View in: PubMed
  65. Kesselheim AS, Huybrechts KF, Choudhry NK, Fulchino LA, Isaman DL, Kowal MK, Brennan TA. Prescription drug insurance coverage and patient health outcomes: a systematic review. Am J Public Health. 2015 Feb; 105(2):e17-30. PMID: 25521879; PMCID: PMC4318289 [Available on 02/01/16].
  66. Darrow JJ, Sarpatwari A, Avorn J, Kesselheim AS. Practical, legal, and ethical issues in expanded access to investigational drugs. N Engl J Med. 2015 Jan 15; 372(3):279-86. PMID: 25587952.
    View in: PubMed
  67. Wang B, Choudhry NK, Gagne JJ, Landon J, Kesselheim AS. Availability and utilization of cardiovascular fixed-dose combination drugs in the United States. Am Heart J. 2015 Mar; 169(3):379-386.e1. PMID: 25728728.
    View in: PubMed
  68. Rajan PV, Kramer DB, Kesselheim AS. Medical device postapproval safety monitoring: where does the United States stand? Circ Cardiovasc Qual Outcomes. 2015 Jan; 8(1):124-31. PMID: 25563662; PMCID: PMC4385582.
  69. Kesselheim AS, McGraw S, Thompson L, O'Keefe K, Gagne JJ. Development and use of new therapeutics for rare diseases: views from patients, caregivers, and advocates. Patient. 2015; 8(1):75-84. PMID: 25362528.
    View in: PubMed
  70. Darrow JJ, Kesselheim AS. A New Wave of Vaccines for Non-Communicable Diseases: What Are the Regulatory Challenges? Food Drug Law J. 2015; 70(2):243-58, i. PMID: 26302599.
    View in: PubMed
  71. Kesselheim AS, Darrow JJ. Hatch-Waxman Turns 30: Do We Need a Re-Designed Approach for the Modern Era? Yale J Health Policy Law Ethics. 2015; 15(2):293-347. PMID: 26333236.
    View in: PubMed
  72. Sarpatwari A, Franklin JM, Avorn J, Seeger JD, Landon JE, Kesselheim AS. Are risk evaluation and mitigation strategies associated with less off-label use of medications? The case of immune thrombocytopenia. Clin Pharmacol Ther. 2015 Feb; 97(2):186-93. PMID: 25670524.
    View in: PubMed
  73. Kesselheim AS, Choudhry NK, Avorn J. Burden of changes in generic pill appearance. Ann Intern Med. 2014 Dec 2; 161(11):840. PMID: 25437416.
    View in: PubMed
  74. Kesselheim AS, Darrow JJ. FDA designations for therapeutics and their impact on drug development and regulatory review outcomes. Clin Pharmacol Ther. 2015 Jan; 97(1):29-36. PMID: 25670381.
    View in: PubMed
  75. Gagne JJ, Thompson L, O'Keefe K, Kesselheim AS. Innovative research methods for studying treatments for rare diseases: methodological review. BMJ. 2014; 349:g6802. PMID: 25422272; PMCID: PMC4242670.
  76. 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. PMID: 25390739.
    View in: PubMed
  77. Wang B, Joffe S, Kesselheim AS. Chemotherapy parity laws: a remedy for high drug costs? JAMA Intern Med. 2014 Nov; 174(11):1721-2. PMID: 25243936.
    View in: PubMed
  78. 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. PMID: 25337755.
    View in: PubMed
  79. 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. PMID: 25314155; PMCID: PMC4196737.
  80. 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; 33(10):1770-8. PMID: 25288421.
    View in: PubMed
  81. 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. PMID: 25247520; PMCID: PMC4209732.
  82. Polinski JM, Kesselheim AS, Seeger JD, Connolly JG, Choudhry NK, Shrank WH. A cross-national comparison of 17 countries' insulin glargine drug labels. Pharmacoepidemiol Drug Saf. 2015 Feb; 24(2):159-65. PMID: 25250724.
    View in: PubMed
  83. 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. PMID: 25222387.
    View in: PubMed
  84. Kesselheim AS, Rajan PV. Regulating incremental innovation in medical devices. BMJ. 2014; 349:g5303. PMID: 25209435.
    View in: PubMed
  85. Duke JD, Kesselheim AS. The Food and Drug Administration's role in promoting consistent labels for generic drugs. JAMA Intern Med. 2014 Aug; 174(8):1213-4. PMID: 24957047.
    View in: PubMed
  86. 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:S709-11. PMID: 25029981; PMCID: PMC4124123.
  87. 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; 174(8):1283-90. PMID: 24911123.
    View in: PubMed
  88. 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. PMID: 25069795.
    View in: PubMed
  89. Cortez NG, Cohen IG, Kesselheim AS. FDA regulation of mobile health technologies. N Engl J Med. 2014 Jul 24; 371(4):372-9. PMID: 25054722.
    View in: PubMed
  90. 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. PMID: 25023248.
    View in: PubMed
  91. 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. PMID: 24988576.
    View in: PubMed
  92. Darrow JJ, Kesselheim AS. Drug development and FDA approval, 1938-2013. N Engl J Med. 2014 Jun 26; 370(26):e39. PMID: 24963591.
    View in: PubMed
  93. 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; 33(6):1014-23. PMID: 24889951.
    View in: PubMed
  94. Hwang TJ, Carpenter D, Kesselheim AS. Target small firms for antibiotic innovation. Science. 2014 May 30; 344(6187):967-9. PMID: 24876477.
    View in: PubMed
  95. 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. PMID: 24842974.
    View in: PubMed
  96. 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. PMID: 24838119.
    View in: PubMed
  97. 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. PMID: 24738666.
    View in: PubMed
  98. Hwang TJ, Kesselheim AS, Bourgeois FT. Postmarketing trials and pediatric device approvals. Pediatrics. 2014 May; 133(5):e1197-202. PMID: 24733871; PMCID: PMC4531281.
  99. 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. PMID: 24670173.
    View in: PubMed
  100. 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. PMID: 24595771.
    View in: PubMed
  101. Luo J, Kesselheim AS. Underrepresentation of older adults in cancer trials. JAMA. 2014 Mar 5; 311(9):965-6. PMID: 24595789.
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  102. 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 Mar; 20(3):e90-7. PMID: 24773330.
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  103. 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. PMID: 24533133; PMCID: PMC3922977.
  104. 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. PMID: 24493775.
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  105. Kesselheim AS, Shiu N. The evolving role of biomarker patents in personalized medicine. Clin Pharmacol Ther. 2014 Feb; 95(2):127-9. PMID: 24448456.
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  106. Hwang TJ, Carpenter D, Kesselheim AS. Assessment of US pathway for approving medical devices for rare conditions. BMJ. 2014; 348:g217. PMID: 24443478.
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  107. 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. PMID: 24449317; PMCID: PMC4142419.
  108. Rome BN, Kramer DB, Kesselheim AS. Approval of high-risk medical devices in the US: implications for clinical cardiology. Curr Cardiol Rep. 2014; 16(6):489. PMID: 24760423; PMCID: PMC4080312.
  109. Miller FG, Joffe S, Kesselheim AS. Evidence, errors, and ethics. Perspect Biol Med. 2014; 57(3):299-307. PMID: 25959345.
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  110. Xu S, Kesselheim AS. Medical innovation then and now: perspectives of innovators responsible for transformative drugs. J Law Med Ethics. 2014; 42(4):564-75. PMID: 25565621.
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  111. Kesselheim AS, Avorn J. New and unproved medical devices. BMJ. 2013; 347:f7413. PMID: 24355541.
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  112. Yeh JS, Kesselheim AS. Same song, different audience: pharmaceutical promotion targeting non-physician health care providers. PLoS Med. 2013 Nov; 10(11):e1001560. PMID: 24302891; PMCID: PMC3841098.
  113. Kesselheim AS, Gagne JJ. Strategies for postmarketing surveillance of drugs for rare diseases. Clin Pharmacol Ther. 2014 Mar; 95(3):265-8. PMID: 24193169.
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  114. Wang B, Kesselheim AS. The role of direct-to-consumer pharmaceutical advertising in patient consumerism. Virtual Mentor. 2013 Nov; 15(11):960-5. PMID: 24257088.
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  115. Austad KE, Avorn J, Franklin JM, Kesselheim AS. Physician trainees' interactions with the pharmaceutical industry. J Gen Intern Med. 2013 Oct; 28(10):1267. PMID: 23797922; PMCID: PMC3785663.
  116. 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. PMID: 24223035; PMCID: PMC3815401.
  117. 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. PMID: 23922000.
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  118. Kramer DB, Kesselheim AS. The medical device excise tax--before it begins? N Engl J Med. 2013 Sep 5; 369(10):984-5. PMID: 24004137.
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  119. 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. PMID: 24001285.
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  120. 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. PMID: 23984672.
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  121. 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. PMID: 23963252.
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  122. 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. PMID: 23765290.
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  123. 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. PMID: 23444007; PMCID: PMC3710396.
  124. Rajkumar R, Kesselheim AS. Balancing access and innovation: India's Supreme Court rules on imatinib. JAMA. 2013 Jul 17; 310(3):263-4. PMID: 23824051.
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  125. 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. PMID: 23841703; PMCID: PMC3777541.
  126. Kesselheim AS. Rising health care costs and life-cycle management in the pharmaceutical market. PLoS Med. 2013; 10(6):e1001461. PMID: 23785261; PMCID: PMC3681333.
  127. Kesselheim AS, Wang B, Avorn J. Defining "innovativeness" in drug development: a systematic review. Clin Pharmacol Ther. 2013 Sep; 94(3):336-48. PMID: 23722626.
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  128. 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. PMID: 23681007.
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  129. 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. PMID: 23635021.
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  130. 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. PMID: 23620531.
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  131. Kramer DB, Kesselheim AS. The medical device excise tax--over before it begins? N Engl J Med. 2013 May 9; 368(19):1767-9. PMID: 23614473; PMCID: PMC3733084.
  132. Kesselheim AS. Drug company gifts to medical students: the hidden curriculum. BMJ. 2013; 346:f1113. PMID: 23427129.
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  133. 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. PMID: 23277164.
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  134. Kesselheim AS, Mello MM, Avorn J. FDA regulation of off-label drug promotion under attack. JAMA. 2013 Feb 6; 309(5):445-6. PMID: 23385267.
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  135. 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. PMID: 24088160.
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  136. Shah AK, Warsh J, Kesselheim AS. The ethics of intellectual property rights in an era of globalization. J Law Med Ethics. 2013; 41(4):841-51, Table of Contents. PMID: 24446942.
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  137. Kesselheim AS, Avorn J, Greene JA. Risk, responsibility, and generic drugs. N Engl J Med. 2012 Nov; 367(18):1679-81. PMID: 23113477; PMCID: PMC4036072.
  138. 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. PMID: 23093563.
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  139. 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. PMID: 23073207.
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  140. 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. PMID: 23034017; PMCID: PMC4258823.
  141. 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. PMID: 23048110.
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  142. 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. PMID: 23048097.
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  143. 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. PMID: 22992075; PMCID: PMC3538846.
  144. 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. PMID: 22968881.
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  145. 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. PMID: 22899894; PMCID: PMC3413710.
  146. Kesselheim AS. Ethical considerations in orphan drug approval and use. Clin Pharmacol Ther. 2012 Aug; 92(2):153-5. PMID: 22814660.
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  147. 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. PMID: 22912563; PMCID: PMC3418047.
  148. 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. PMID: 22767914; PMCID: PMC4256075.
  149. 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. PMID: 22621421.
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  150. 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. PMID: 22363762; PMCID: PMC3283698.
  151. 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. PMID: 22332952.
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  152. 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. PMID: 23061571.
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  153. 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. PMID: 23061573.
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  154. Cole LW, Kesselheim JC, Kesselheim AS. Ethical issues in new drug prescribing. J Bioeth Inq. 2012 Mar; 9(1):77-83. PMID: 23180203.
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  155. 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. PMID: 22147859.
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  156. 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. PMID: 22147858.
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  157. Avorn J, Kesselheim AS. The NIH translational research center might trade public risk for private reward. Nat Med. 2011 Oct; 17(10):1176. PMID: 21988983.
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  158. 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. PMID: 21916635.
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  159. Austad KE, Kesselheim AS. Conflict of interest disclosure in early education of medical students. JAMA. 2011 Sep 7; 306(9):991-2. PMID: 21900140.
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  160. 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. PMID: 21933276; PMCID: PMC3214718.
  161. 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. PMID: 21879888.
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  162. Kesselheim AS. The backlash against bioequivalence and the interchangeability of brand-name and generic drugs. CMAJ. 2011 Sep 6; 183(12):1350-1. PMID: 21746827; PMCID: PMC3168615.
  163. 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. PMID: 21732842.
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  164. 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. PMID: 21717432.
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  165. Carpenter D, Kesselheim AS, Joffe S. Reputation and precedent in the bevacizumab decision. N Engl J Med. 2011 Jul 14; 365(2):e3. PMID: 21707383.
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  166. 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. PMID: 21642684.
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  167. 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. PMID: 21629685; PMCID: PMC3101205.
  168. Kesselheim A. Safety, supply, and suits--litigation and the vaccine industry. N Engl J Med. 2011 Apr 21; 364(16):1485-7. PMID: 21506740.
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  169. Avorn J, Kesselheim A. A hemorrhage of off-label use. Ann Intern Med. 2011 Apr 19; 154(8):566-7. PMID: 21502655.
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  170. 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. PMID: 21483716; PMCID: PMC3071370.
  171. 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. PMID: 21435421.
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  172. Kesselheim AS. Covert pharmaceutical promotion in free medical journals. CMAJ. 2011 Mar 22; 183(5):534-5. PMID: 21398227; PMCID: PMC3060177.
  173. 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. PMID: 21296323; PMCID: PMC3601901.
  174. 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. PMID: 21226569.
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  175. 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. PMID: 21847880.
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  176. 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. PMID: 21170064.
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  177. Kesselheim AS, Outterson K. Improving antibiotic markets for long-term sustainability. Yale J Health Policy Law Ethics. 2011; 11(1):101-67. PMID: 21381513.
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  178. Greene JA, Kesselheim AS. Pharmaceutical marketing and the new social media. N Engl J Med. 2010 Nov 25; 363(22):2087-9. PMID: 21105789.
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  179. 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. PMID: 21087678.
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  180. Kesselheim AS. Using market-exclusivity incentives to promote pharmaceutical innovation. N Engl J Med. 2010 Nov 4; 363(19):1855-62. PMID: 21047231.
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  181. 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. PMID: 20921484.
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  182. 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. PMID: 20731566.
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  183. 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. PMID: 20820028.
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  184. 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. PMID: 20650332; PMCID: PMC3001282.
  185. Kesselheim AS, Maisel WH. Managing financial and nonfinancial conflicts of interest in healthcare delivery. Am J Ther. 2010 Jul-Aug; 17(4):440-3. PMID: 20215960.
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  186. 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. PMID: 20606192; PMCID: PMC3103121.
  187. Kesselheim AS. Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety. Clin Pharmacol Ther. 2010 Jun; 87(6):645-7. PMID: 20485322.
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  188. 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. PMID: 20463344.
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  189. 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. PMID: 20482746.
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  190. Kesselheim AS, Solomon DH. Incentives for drug development--the curious case of colchicine. N Engl J Med. 2010 Jun 3; 362(22):2045-7. PMID: 20393164.
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  191. Kesselheim AS, Mello MM. Gene patenting--is the pendulum swinging back? N Engl J Med. 2010 May 20; 362(20):1855-8. PMID: 20375396.
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  192. 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. PMID: 20329806; PMCID: PMC3056509.
  193. 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. PMID: 20026595.
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  194. Kesselheim AS. The Supreme Court, process patents, and medical innovation. N Engl J Med. 2009 Dec 10; 361(24):2303-6. PMID: 19923562.
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  195. 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. PMID: 19828525.
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  196. 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. PMID: 19706627.
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  197. Outterson K, Kesselheim AS. How Medicare could get better prices on prescription drugs. Health Aff (Millwood). 2009 Sep-Oct; 28(5):w832-41. PMID: 19643778.
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  198. 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. PMID: 19451908.
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  199. Kesselheim AS, Studdert DM. The Supreme Court, preemption, and malpractice liability. N Engl J Med. 2009 Feb 5; 360(6):559-61. PMID: 19196672.
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  200. Kesselheim AS, Avorn J. Using patent data to assess the value of pharmaceutical innovation. J Law Med Ethics. 2009; 37(2):176-83. PMID: 19493065.
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  201. 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. PMID: 19106694.
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  202. 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. PMID: 19050195; PMCID: PMC2713758.
  203. Kesselheim AS. Drug development for neglected diseases - the trouble with FDA review vouchers. N Engl J Med. 2008 Nov 6; 359(19):1981-3. PMID: 18987367.
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  204. 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. PMID: 18765704.
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  205. Kesselheim AS, Avorn J. Pharmaceutical promotion to physicians and First Amendment rights. N Engl J Med. 2008 Apr 17; 358(16):1727-32. PMID: 18420505.
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  206. 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. PMID: 18413623.
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  207. Chokshi DA, Kesselheim AS. Rethinking global access to vaccines. BMJ. 2008 Apr 5; 336(7647):750-3. PMID: 18390526; PMCID: PMC2287260.
  208. Dudzinski DM, Kesselheim AS. Scientific and legal viability of follow-on protein drugs. N Engl J Med. 2008 Feb 21; 358(8):843-9. PMID: 18287608.
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  209. 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. PMID: 18697689.
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  210. Outterson K, Kesselheim AS. Market-based licensing for HPV vaccines in developing countries. Health Aff (Millwood). 2008 Jan-Feb; 27(1):130-9. PMID: 18180488.
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  211. Kesselheim AS, Studdert DM. Role of professional organizations in regulating physician expert witness testimony. JAMA. 2007 Dec 26; 298(24):2907-9. PMID: 18159060.
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  212. 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. PMID: 17846395.
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  213. 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. PMID: 17915832; PMCID: PMC2751478.
  214. 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.
  215. Kesselheim AS and Avorn J. The role of litigation in drug safety. Journal of the American Medical Association. 2007; 297(3):308-311.
  216. 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.
  217. Kesselheim AS, Mello MM. Medical process patents – monopolizing the delivery of health care. New England Journal of Medicine. 2006; 355(19):2036-2041.
  218. 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.
  219. 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. PMID: 17699340.
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  220. 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.
  221. 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.
  222. 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. PMID: 16622145.
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  223. 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.
  224. 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. PMID: 16444919.
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  225. 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.
  226. Kesselheim AS and Avorn J. Biotechnology products and university-based science. Journal of the American Medical Association. 2005; 293(23):2863.
  227. Kesselheim AS and Brennan TA. Overbilling vs. downcoding — the battle between physicians and insurers. New England Journal of Medicine. 2005; 352(9):855-857.
  228. 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.
  229. 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. PMID: 15742588.
    View in: PubMed
  230. Kesselheim AS. Patents and intellectual property in medicine. Legal Medicine. 2004; 207-213.
  231. Kesselheim AS. Perspectives: ode to a short white coat. Pharos. 2003; 66:35.
  232. 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.
  233. Kissick WL and Kesselheim AS. Presidential disability: the panel of physicians. Transactions & Studies of the College of Physicians of Philadelphia. 2001; 23:113-119.
  234. Kesselheim AS. Deception and presidential disability: an historical analysis. Trans Stud Coll Physicians Phila. 2001 Dec; 23:87-98. PMID: 12087853.
    View in: PubMed
  235. 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.
  236. 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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