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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 Research 
Collapse research activities and funding
The research activities and funding listed below are automatically derived from NIH ExPORTER and other sources, which might result in incorrect or missing items. Faculty can login to make corrections and additions.
U01FD004856     (KESSELHEIM, AARON SETH)Sep 15, 2013 - Sep 14, 2014
FDA
Assessing Clinical Equivalence for Generic Drugs Approved By Innovative Methods
Role: Principal Investigator

K08HS018465     (KESSELHEIM, AARON SETH)Sep 30, 2009 - Jul 31, 2014
AHRQ
Off-label prescribing: Comparative evidence, regulation, and utilization
Role: Principal Investigator

Collapse Featured Content 
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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, Cohen IG, Adashi EY, Kesselheim AS. Influence, integrity, and the FDA: An ethical framework. Science. 2017 Sep 01; 357(6354):876-877. PMID: 28860375.
    View in: PubMed
  2. Naci H, Smalley KR, Kesselheim AS. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration. JAMA. 2017 Aug 15; 318(7):626-636. PMID: 28810023.
    View in: PubMed
  3. Hwang TJ, Kesselheim AS, Sarpatwari A. Value-Based Pricing and State Reform of Prescription Drug Costs. JAMA. 2017 08 15; 318(7):609-610. PMID: 28692713.
    View in: PubMed
  4. Bonnie RJ, Kesselheim AS, Clark DJ. Both Urgency and Balance Needed in Addressing Opioid Epidemic: A Report From the National Academies of Sciences, Engineering, and Medicine. JAMA. 2017 Aug 01; 318(5):423-424. PMID: 28715551.
    View in: PubMed
  5. Jain N, Hwang T, Franklin JM, Kesselheim AS. Association of the Priority Review Voucher With Neglected Tropical Disease Drug and Vaccine Development. JAMA. 2017 07 25; 318(4):388-389. PMID: 28742898.
    View in: PubMed
  6. Dave CV, Kesselheim AS, Fox ER, Qiu P, Hartzema A. High Generic Drug Prices and Market Competition: A Retrospective Cohort Study. Ann Intern Med. 2017 Aug 01; 167(3):145-151. PMID: 28672324.
    View in: PubMed
  7. Kramer DB, Kesselheim AS. Coverage of Magnetic Resonance Imaging for Patients With Cardiac Devices: Improving the Coverage With Evidence Development Program. JAMA Cardiol. 2017 Jul 01; 2(7):711-712. PMID: 28492917.
    View in: PubMed
  8. Hwang TJ, Kesselheim AS. Challenges in the Development of Novel Cardiovascular Therapies. Clin Pharmacol Ther. 2017 Aug; 102(2):194-196. PMID: 28643861.
    View in: PubMed
  9. Hey SP, Franklin JM, Avorn J, Kesselheim AS. Success, Failure, and Transparency in Biomarker-Based Drug Development: A Case Study of Cholesteryl Ester Transfer Protein Inhibitors. Circ Cardiovasc Qual Outcomes. 2017 Jun; 10(6). PMID: 28611186.
    View in: PubMed
  10. Kesselheim AS, McGraw SA, Dejene SZ, Rausch P, Dal Pan GJ, Lappin BM, Zhou EH, Avorn J, Campbell EG. Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study. Drug Saf. 2017 Jun; 40(6):531-542. PMID: 28247279.
    View in: PubMed
  11. Hwang TJ, Franklin JM, Kesselheim AS. Effect of US Food and Drug Administration's Cardiovascular Safety Guidance on Diabetes Drug Development. Clin Pharmacol Ther. 2017 Aug; 102(2):290-296. PMID: 28390139.
    View in: PubMed
  12. Gellad WF, Kesselheim AS. Accelerated Approval and Expensive Drugs - A Challenging Combination. N Engl J Med. 2017 May 25; 376(21):2001-2004. PMID: 28538133.
    View in: PubMed
  13. Fralick M, Kesselheim AS. FDA Approval of Desmopressin for Nocturia. JAMA. 2017 05 23; 317(20):2059-2060. PMID: 28384655.
    View in: PubMed
  14. Luo J, Kesselheim AS, Avorn J. Medicaid Expenditures and Estimated Rebates for Epinephrine Autoinjectors, 2012 to 2016. JAMA Intern Med. 2017 May 01; 177(5):734-736. PMID: 28346577.
    View in: PubMed
  15. Kesselheim AS, Donneyong M, Dal Pan GJ, Zhou EH, Avorn J, Schneeweiss S, Seeger JD. Changes in prescribing and healthcare resource utilization after FDA Drug Safety Communications involving zolpidem-containing medications. Pharmacoepidemiol Drug Saf. 2017 Jun; 26(6):712-721. PMID: 28449404.
    View in: PubMed
  16. Chen CT, Kesselheim AS. Journey of Generic Imatinib: A Case Study in Oncology Drug Pricing. J Oncol Pract. 2017 Jun; 13(6):352-355. PMID: 28445102.
    View in: PubMed
  17. Davies BJ, Hwang TJ, Kesselheim AS. Ensuring Access to Injectable Generic Drugs - The Case of Intravesical BCG for Bladder Cancer. N Engl J Med. 2017 Apr 13; 376(15):1401-1403. PMID: 28402764.
    View in: PubMed
  18. Fralick M, Kesselheim AS. Three design aspects for high quality post-marketing cohort studies. BMJ. 2017 Apr 12; 357:j1851. PMID: 28404570.
    View in: PubMed
  19. Kesselheim AS, Avorn J. FDA Approval of Eteplirsen for Muscular Dystrophy-Reply. JAMA. 2017 04 11; 317(14):1481-1482. PMID: 28399248.
    View in: PubMed
  20. Wang B, Studdert DM, Sarpatwari A, Franklin JM, Landon J, Kesselheim AS. The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine. PLoS One. 2017; 12(4):e0175313. PMID: 28388667.
    View in: PubMed
  21. Kesselheim AS, Gagne JJ, Franklin JM, Eddings W, Fulchino LA, Campbell EG. Do patients trust the FDA?: a survey assessing how patients view the generic drug approval process. Pharmacoepidemiol Drug Saf. 2017 Jun; 26(6):694-701. PMID: 28370652.
    View in: PubMed
  22. Woloshin S, Schwartz LM, Dejene S, Rausch P, Dal Pan GJ, Zhou EH, Kesselheim AS. Media Coverage of FDA Drug Safety Communications about Zolpidem: A Quantitative and Qualitative Analysis. J Health Commun. 2017 May; 22(5):365-372. PMID: 28339323.
    View in: PubMed
  23. Hey SP, Kesselheim AS. Reprioritizing Research Activity for the Post-Antibiotic Era: Ethical, Legal, and Social Considerations. Hastings Cent Rep. 2017 Mar; 47(2):16-20. PMID: 28301705.
    View in: PubMed
  24. Gagne JJ, Polinski JM, Jiang W, Dutcher SK, Xie J, Lii J, Fulchino LA, Kesselheim AS. Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence. Drugs. 2017 Mar; 77(4):427-433. PMID: 28181177.
    View in: PubMed
  25. Fralick M, Kesselheim AS. Periodic benefit-risk evaluation reports have substantial promise to guide patient care and should be made publicly available. Pharmacoepidemiol Drug Saf. 2017 May; 26(5):597-599. PMID: 28198116.
    View in: PubMed
  26. Kesselheim AS, Avorn J. New "21st Century Cures" Legislation: Speed and Ease vs Science. JAMA. 2017 02 14; 317(6):581-582. PMID: 28056124.
    View in: PubMed
  27. Luo J, Kesselheim AS, Greene J, Lipska KJ. Strategies to improve the affordability of insulin in the USA. Lancet Diabetes Endocrinol. 2017 Mar; 5(3):158-159. PMID: 28189654.
    View in: PubMed
  28. Fralick M, Kesselheim A, Avorn J. Applying Academic Detailing and Process Change to Promote Choosing Wisely. JAMA Intern Med. 2017 Feb 01; 177(2):282. PMID: 28166340.
    View in: PubMed
  29. Guo E, Jacobs DB, Kesselheim AS. Eliminating Coverage Discrimination Through the Essential Health Benefit's Anti-Discrimination Provisions. Am J Public Health. 2017 Feb; 107(2):253-254. PMID: 28075637.
    View in: PubMed
  30. Sarpatwari A, Gagne JJ, Levidow NL, Kesselheim AS. Active Surveillance of Follow-on Biologics: A Prescription for Uptake. Drug Saf. 2017 Feb; 40(2):105-108. PMID: 27838823.
    View in: PubMed
  31. Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST. Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005-2014. Otolaryngol Head Neck Surg. 2017 Apr; 156(4):683-692. PMID: 28116974.
    View in: PubMed
  32. Kesselheim AS, Rome BN, Sarpatwari A, Avorn J. Six-Month Market Exclusivity Extensions To Promote Research Offer Substantial Returns For Many Drug Makers. Health Aff (Millwood). 2017 Feb 01; 36(2):362-370. PMID: 28100464.
    View in: PubMed
  33. Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST. Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014. Otolaryngol Head Neck Surg. 2017 Feb; 156(2):285-288. PMID: 28093943.
    View in: PubMed
  34. Deak D, Powers JH, Outterson K, Kesselheim AS. The Fight Against Multidrug-Resistant Bacteria. Ann Intern Med. 2017 Jan 03; 166(1):79. PMID: 28030672.
    View in: PubMed
  35. Kesselheim AS, Treasure CL, Joffe S. Biomarker-Defined Subsets of Common Diseases: Policy and Economic Implications of Orphan Drug Act Coverage. PLoS Med. 2017 Jan; 14(1):e1002190. PMID: 28045970.
    View in: PubMed
  36. Gupta R, Kesselheim AS, Ross JS. Prioritization of Generic Drug Review-Reply. JAMA Intern Med. 2017 Jan 01; 177(1):141-142. PMID: 28030736.
    View in: PubMed
  37. Sarpatwari A, Avorn J, Kesselheim AS. Factors Influencing Prescription Drug Costs in the United States-Reply. JAMA. 2016 12 13; 316(22):2431-2432. PMID: 27959994.
    View in: PubMed
  38. Kesselheim AS, Avorn J. Approving a Problematic Muscular Dystrophy Drug: Implications for FDA Policy. JAMA. 2016 12 13; 316(22):2357-2358. PMID: 27775756.
    View in: PubMed
  39. Hwang TJ, Carpenter D, Lauffenburger JC, Wang B, Franklin JM, Kesselheim AS. Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results. JAMA Intern Med. 2016 Dec 01; 176(12):1826-1833. PMID: 27723879.
    View in: PubMed
  40. Luo J, Gagne JJ, Landon J, Avorn J, Kesselheim AS. Comparative effectiveness and safety of thalidomide and lenalidomide in patients with multiple myeloma in the United States of America: A population-based cohort study. Eur J Cancer. 2017 Jan; 70:22-33. PMID: 27866096.
    View in: PubMed
  41. Robertson C, Kesselheim AS. Regulating Off-Label Promotion - A Critical Test. N Engl J Med. 2016 Dec 15; 375(24):2313-2315. PMID: 27805841.
    View in: PubMed
  42. Hwang TJ, Kesselheim AS. Public referendum on drug prices in the US: will it bring relief? BMJ. 2016 Oct 31; 355:i5657. PMID: 27799143.
    View in: PubMed
  43. Kesselheim AS, Eddings W, Raj T, Campbell EG, Franklin JM, Ross KM, Fulchino LA, Avorn J, Gagne JJ. Physicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug Approval. PLoS One. 2016; 11(10):e0163339. PMID: 27768700.
    View in: PubMed
  44. Kimmelman J, Kesselheim AS. Translational research and the U.S. federal elections. Sci Transl Med. 2016 Oct 19; 8(361):361ed13. PMID: 27798261.
    View in: PubMed
  45. Kesselheim AS, Gagne JJ. Prescription Trends-Brand-Name Drugs vs Generic-Reply. JAMA Intern Med. 2016 Oct 01; 176(10):1574-1575. PMID: 27695842.
    View in: PubMed
  46. Yeh JS, Franklin JM, Kesselheim AS. Payments to Physicians, Prescribing Rates, and More Appropriate Conclusions-Reply. JAMA Intern Med. 2016 Oct 01; 176(10):1577. PMID: 27695845.
    View in: PubMed
  47. Kesselheim AS, Bykov K, Gagne JJ, Wang SV, Choudhry NK. Switching generic antiepileptic drug manufacturer not linked to seizures: A case-crossover study. Neurology. 2016 Oct 25; 87(17):1796-1801. PMID: 27683844.
    View in: PubMed
  48. Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS. Generic Drug Approvals Since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016 Sep 01; 176(9):1391-3. PMID: 27428055.
    View in: PubMed
  49. Luo J, Seeger JD, Donneyong M, Gagne JJ, Avorn J, Kesselheim AS. Effect of Generic Competition on Atorvastatin Prescribing and Patients' Out-of-Pocket Spending. JAMA Intern Med. 2016 Sep 01; 176(9):1317-23. PMID: 27367749.
    View in: PubMed
  50. Sinha MS, Kesselheim AS. Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals. Bioorg Med Chem. 2016 Dec 15; 24(24):6446-6451. PMID: 27591793.
    View in: PubMed
  51. Hey SP, Kesselheim AS. The FDA, Juno Therapeutics, and the ethical imperative of transparency. BMJ. 2016 Aug 15; 354:i4435. PMID: 27526698.
    View in: PubMed
  52. Kesselheim AS, Avorn J, Sarpatwari A. The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform. JAMA. 2016 Aug 23-30; 316(8):858-71. PMID: 27552619.
    View in: PubMed
  53. 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
  54. Hey SP, Kesselheim AS. BIOMEDICAL RESEARCH. Countering imprecision in precision medicine. Science. 2016 Jul 29; 353(6298):448-9. PMID: 27471295.
    View in: PubMed
  55. 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 Jul 01; 18(7):727-35. PMID: 27437823.
    View in: PubMed
  56. 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 Jun 28; 353:i3323. PMID: 27352914; PMCID: PMC4925918.
  57. Sarpatwari A, Kesselheim AS. Navigating the Dermatological Drug Cost Curve. JAMA. 2016 Jun 28; 315(24):2724-5. PMID: 27367767.
    View in: PubMed
  58. 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
  59. Engelberg AB, Kesselheim AS. Use the Bayh-Dole Act to lower drug prices for government healthcare programs. Nat Med. 2016 Jun 07; 22(6):576. PMID: 27270771.
    View in: PubMed
  60. 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 01; 176(6):763-8. PMID: 27159336.
    View in: PubMed
  61. 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 01; 176(6):845-7. PMID: 27158897.
    View in: PubMed
  62. Treasure CL, Kesselheim AS. How Patent Troll Legislation Can Increase Timely Access to Generic Drugs. JAMA Intern Med. 2016 Jun 01; 176(6):729-30. PMID: 27183456.
    View in: PubMed
  63. Deak D, Outterson K, Powers JH, Kesselheim AS. Progress in the Fight Against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration-Approved Antibiotics, 2010-2015. Ann Intern Med. 2016 Sep 06; 165(5):363-72. PMID: 27239977.
    View in: PubMed
  64. 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
  65. 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; PMCID: PMC4848142 [Available on 05/01/17].
  66. Kapczynski A, Kesselheim AS. 'Government Patent Use': A Legal Approach To Reducing Drug Spending. Health Aff (Millwood). 2016 May 01; 35(5):791-7. PMID: 27140984.
    View in: PubMed
  67. 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 01; 1(2):117-8. PMID: 27437879.
    View in: PubMed
  68. 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
  69. Sarpatwari A, Kesselheim AS. Efficacy of the Priority Review Voucher Program. JAMA. 2016 Apr 19; 315(15):1660-1. PMID: 27092839.
    View in: PubMed
  70. 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
  71. Capati VC, Kesselheim AS. Drug Product Life-Cycle Management as Anticompetitive Behavior: The Case of Memantine. J Manag Care Spec Pharm. 2016 Apr; 22(4):339-44. PMID: 27023687.
    View in: PubMed
  72. 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; PMCID: PMC4816295.
  73. Hey SP, Kesselheim AS. An Uninformative Truth: The Logic of Amarin's Off-Label Promotion. PLoS Med. 2016 Mar; 13(3):e1001978. PMID: 26978686; PMCID: PMC4792458.
  74. Wang B, Kesselheim AS. Promoting Therapeutic Innovation: What Do We Do About Drug-Device Combinations? JAMA. 2016 Mar 01; 315(9):857-8. PMID: 26934246.
    View in: PubMed
  75. Luo J, Avorn J, Kesselheim AS. Inaccurate Reporting of Insulin Reimbursement-Reply. JAMA Intern Med. 2016 Mar; 176(3):408-9. PMID: 26954041.
    View in: PubMed
  76. 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; PMCID: PMC4870419 [Available on 06/01/17].
  77. 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; PMCID: PMC4747525.
  78. 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
  79. 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; 35(2):219-26. PMID: 26858373.
    View in: PubMed
  80. 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
  81. Kesselheim AS, Hwang TJ. Breakthrough Medical Devices and the 21st Century Cures Act. Ann Intern Med. 2016 Apr 05; 164(7):500-2. PMID: 26785350.
    View in: PubMed
  82. 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; PMCID: PMC4675417 [Available on 12/01/16].
  83. Kesselheim AS, Sinha MS, Joffe S. Physicians and Insider Trading. JAMA Intern Med. 2015 Dec; 175(12):1955-9. PMID: 26457747.
    View in: PubMed
  84. 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; PMCID: PMC4678939 [Available on 12/01/16].
  85. Luo J, Kesselheim AS. Cost-effectiveness of Statin Therapy for ASCVD. JAMA. 2015 Nov 24; 314(20):2191. PMID: 26599189.
    View in: PubMed
  86. 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
  87. 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; PMCID: PMC4685151.
  88. 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
  89. 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
  90. 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
  91. 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
  92. 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
  93. 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
  94. Luo J, Avorn J, Kesselheim AS. Trends in Medicaid Reimbursements for Insulin From 1991 Through 2014. JAMA Intern Med. 2015 Oct; 175(10):1681-6. PMID: 26301721.
    View in: PubMed
  95. 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 Sep 23; 351:h4633. PMID: 26400751; PMCID: PMC4580726.
  96. 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 Sep 23; 351:h4679. PMID: 26400844; PMCID: PMC4580725.
  97. 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].
  98. 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.
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  99. Avorn J, Sarpatwari A, Kesselheim AS. Forbidden and Permitted Statements about Medications--Loosening the Rules. N Engl J Med. 2015 Sep 03; 373(10):967-73. PMID: 26332553.
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  100. 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.
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  101. Sharfstein JM, Kesselheim AS. The Safety of Prescription Drugs. JAMA. 2015 Jul 21; 314(3):233-4. PMID: 26197182.
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  102. 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.
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  103. 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.
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  104. 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.
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  105. 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.
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  106. 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.
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  107. 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.
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  108. Sarpatwari A, Darrow JJ, Kesselheim AS. Expanded access to investigational drugs. N Engl J Med. 2015 Apr 09; 372(15):1473-4. PMID: 25853762.
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  109. 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].
  110. 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.
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  111. 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.
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  112. 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.
  113. 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.
  114. 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.
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  115. Hwang TJ, Carpenter D, Kesselheim AS. Paying for innovation: reimbursement incentives for antibiotics. Sci Transl Med. 2015 Feb 25; 7(276):276fs9. PMID: 25717095.
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  116. 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.
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  117. 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.
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  118. 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 Feb; 8(1):75-84. PMID: 25362528.
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  119. 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.
  120. 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.
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  121. 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.
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  122. 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.
  123. 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.
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  124. 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.
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  125. 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.
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  126. Kesselheim AS, Choudhry NK, Avorn J. Burden of changes in generic pill appearance. Ann Intern Med. 2014 Dec 02; 161(11):840. PMID: 25437416.
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  127. 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.
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  128. Gagne JJ, Thompson L, O'Keefe K, Kesselheim AS. Innovative research methods for studying treatments for rare diseases: methodological review. BMJ. 2014 Nov 24; 349:g6802. PMID: 25422272; PMCID: PMC4242670.
  129. 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.
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  130. 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.
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  131. 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.
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  132. 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.
  133. Kirschner NM, Sulmasy LS, Kesselheim AS. Health policy basics: the Physician Payment Sunshine Act and the Open Payments program. Ann Intern Med. 2014 Oct 07; 161(7):519-21. PMID: 25069795.
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  134. 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.
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  135. 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.
  136. 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.
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  137. 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.
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  138. Kesselheim AS, Rajan PV. Regulating incremental innovation in medical devices. BMJ. 2014 Sep 09; 349:g5303. PMID: 25209435.
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  139. 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.
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  140. 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.
  141. 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.
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  142. 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.
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  143. 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.
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  144. Darrow JJ, Avorn J, Kesselheim AS. New FDA breakthrough-drug category--implications for patients. N Engl J Med. 2014 Jul 03; 371(1):89-90. PMID: 24988576.
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  145. Darrow JJ, Kesselheim AS. Drug development and FDA approval, 1938-2013. N Engl J Med. 2014 Jun 26; 370(26):e39. PMID: 24963591.
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  146. 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.
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  147. Hwang TJ, Carpenter D, Kesselheim AS. Target small firms for antibiotic innovation. Science. 2014 May 30; 344(6187):967-9. PMID: 24876477.
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  148. 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.
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  149. 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.
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  150. 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.
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  151. Hwang TJ, Kesselheim AS, Bourgeois FT. Postmarketing trials and pediatric device approvals. Pediatrics. 2014 May; 133(5):e1197-202. PMID: 24733871; PMCID: PMC4531281.
  152. 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.
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  153. Treasure CL, Avorn J, Kesselheim AS. What is the public's right to access medical discoveries based on federally funded research? JAMA. 2014 Mar 05; 311(9):907-8. PMID: 24595771.
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  154. Luo J, Kesselheim AS. Underrepresentation of older adults in cancer trials. JAMA. 2014 Mar 05; 311(9):965-6. PMID: 24595789.
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  155. 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 01; 20(3):e90-7. PMID: 24773330.
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  156. 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.
  157. 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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  158. 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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  159. Hwang TJ, Carpenter D, Kesselheim AS. Assessment of US pathway for approving medical devices for rare conditions. BMJ. 2014 Jan 17; 348:g217. PMID: 24443478.
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  160. 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.
  161. 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.
  162. Miller FG, Joffe S, Kesselheim AS. Evidence, errors, and ethics. Perspect Biol Med. 2014; 57(3):299-307. PMID: 25959345.
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  163. 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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  164. Kesselheim AS, Avorn J. New and unproved medical devices. BMJ. 2013 Dec 19; 347:f7413. PMID: 24355541.
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  165. 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.
  166. 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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  167. Wang B, Kesselheim AS. The role of direct-to-consumer pharmaceutical advertising in patient consumerism. Virtual Mentor. 2013 Nov 01; 15(11):960-5. PMID: 24257088.
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  168. 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.
  169. 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.
  170. 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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  171. Kramer DB, Kesselheim AS. The medical device excise tax--over before it begins? N Engl J Med. 2013 09 05; 369(10):984-5. PMID: 24004137.
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  172. 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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  173. 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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  174. 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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  175. 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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  176. 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.
  177. 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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  178. 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.
  179. Kesselheim AS. Rising health care costs and life-cycle management in the pharmaceutical market. PLoS Med. 2013; 10(6):e1001461. PMID: 23785261; PMCID: PMC3681333.
  180. 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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  181. Kesselheim AS, Avorn J. The most transformative drugs of the past 25 years: a survey of physicians. Nat Rev Drug Discov. 2013 06; 12(6):425-31. PMID: 23681007.
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  182. 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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  183. 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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  184. Kramer DB, Kesselheim AS. The medical device excise tax--over before it begins? N Engl J Med. 2013 May 09; 368(19):1767-9. PMID: 23614473; PMCID: PMC3733084.
  185. Kesselheim AS. Drug company gifts to medical students: the hidden curriculum. BMJ. 2013 Feb 20; 346:f1113. PMID: 23427129.
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  186. 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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  187. Kesselheim AS, Mello MM, Avorn J. FDA regulation of off-label drug promotion under attack. JAMA. 2013 Feb 06; 309(5):445-6. PMID: 23385267.
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  188. 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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  189. 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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  190. Kesselheim AS, Avorn J, Greene JA. Risk, responsibility, and generic drugs. N Engl J Med. 2012 11 01; 367(18):1679-81. PMID: 23113477; PMCID: PMC4036072.
  191. 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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  192. 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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  193. Kramer DB, Kesselheim AS. User fees and beyond--the FDA Safety and Innovation Act of 2012. N Engl J Med. 2012 Oct 04; 367(14):1277-9. PMID: 23034017; PMCID: PMC4258823.
  194. 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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  195. 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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  196. 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.
  197. 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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  198. 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.
  199. 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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  200. 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.
  201. Truog RD, Kesselheim AS, Joffe S. Research ethics. Paying patients for their tissue: the legacy of Henrietta Lacks. Science. 2012 Jul 06; 337(6090):37-8. PMID: 22767914; PMCID: PMC4256075.
  202. 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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  203. 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.
  204. Kramer DB, Xu S, Kesselheim AS. Regulation of medical devices in the United States and European Union. N Engl J Med. 2012 Mar 01; 366(9):848-55. PMID: 22332952.
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  205. 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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  206. 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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  207. 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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  208. 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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  209. 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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  210. Avorn J, Kesselheim AS. The NIH translational research center might trade public risk for private reward. Nat Med. 2011 Oct 11; 17(10):1176. PMID: 21988983.
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  211. 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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  212. Austad KE, Kesselheim AS. Conflict of interest disclosure in early education of medical students. JAMA. 2011 Sep 07; 306(9):991-2. PMID: 21900140.
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  213. 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.
  214. 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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  215. Kesselheim AS. The backlash against bioequivalence and the interchangeability of brand-name and generic drugs. CMAJ. 2011 Sep 06; 183(12):1350-1. PMID: 21746827; PMCID: PMC3168615.
  216. Greene JA, Kesselheim AS. Why do the same drugs look different? Pills, trade dress, and public health. N Engl J Med. 2011 Jul 07; 365(1):83-9. PMID: 21732842.
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  217. 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 01; 118(1):188-95. PMID: 21717432.
    View in: PubMed
  218. 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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  219. Kesselheim AS, Myers JA, Avorn J. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer. JAMA. 2011 Jun 08; 305(22):2320-6. PMID: 21642684.
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  220. 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.
  221. 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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  222. 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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  223. 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.
  224. 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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  225. Kesselheim AS. Covert pharmaceutical promotion in free medical journals. CMAJ. 2011 Mar 22; 183(5):534-5. PMID: 21398227; PMCID: PMC3060177.
  226. 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 01; 107(7):1071-1075.e5. PMID: 21296323; PMCID: PMC3601901.
  227. 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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  228. 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.
    View in: PubMed
  229. 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.
    View in: PubMed
  230. Kesselheim AS, Outterson K. Improving antibiotic markets for long-term sustainability. Yale J Health Policy Law Ethics. 2011; 11(1):101-67. PMID: 21381513.
    View in: PubMed
  231. 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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  232. 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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  233. Kesselheim AS. Using market-exclusivity incentives to promote pharmaceutical innovation. N Engl J Med. 2010 Nov 04; 363(19):1855-62. PMID: 21047231.
    View in: PubMed
  234. 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.
    View in: PubMed
  235. 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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  236. 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.
    View in: PubMed
  237. 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.
  238. 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.
    View in: PubMed
  239. 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.
  240. 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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  241. 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.
    View in: PubMed
  242. 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.
    View in: PubMed
  243. Kesselheim AS, Solomon DH. Incentives for drug development--the curious case of colchicine. N Engl J Med. 2010 Jun 03; 362(22):2045-7. PMID: 20393164.
    View in: PubMed
  244. Kesselheim AS, Mello MM. Gene patenting--is the pendulum swinging back? N Engl J Med. 2010 May 20; 362(20):1855-8. PMID: 20375396.
    View in: PubMed
  245. 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.
  246. 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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  247. 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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  248. 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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  249. 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.
    View in: PubMed
  250. 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.
    View in: PubMed
  251. 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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  252. Schrag D, Naughton M, Kesselheim A, Archer L, Niedzwiedcki D, Romanus D, Goldberg R, Venook A. Clinical trial participants' strategies for coping with prescription drug costs: A companion study to CALGB 80405. J Clin Oncol. 2009 May 20; 27(15_suppl):9503. PMID: 27964454.
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  253. Kesselheim AS, Studdert DM. The Supreme Court, preemption, and malpractice liability. N Engl J Med. 2009 Feb 05; 360(6):559-61. PMID: 19196672.
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  254. 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.
    View in: PubMed
  255. 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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  256. 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 03; 300(21):2514-26. PMID: 19050195; PMCID: PMC2713758.
  257. Kesselheim AS. Drug development for neglected diseases - the trouble with FDA review vouchers. N Engl J Med. 2008 Nov 06; 359(19):1981-3. PMID: 18987367.
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  258. 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 02; 149(5):342-9. PMID: 18765704.
    View in: PubMed
  259. 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.
    View in: PubMed
  260. 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.
    View in: PubMed
  261. Chokshi DA, Kesselheim AS. Rethinking global access to vaccines. BMJ. 2008 Apr 05; 336(7647):750-3. PMID: 18390526; PMCID: PMC2287260.
  262. 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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  263. 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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  264. 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.
    View in: PubMed
  265. Kesselheim AS, Studdert DM. Role of professional organizations in regulating physician expert witness testimony. JAMA. 2007 Dec 26; 298(24):2907-9. PMID: 18159060.
    View in: PubMed
  266. 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.
    View in: PubMed
  267. 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 Aug 03; 9(3):E306-11. PMID: 17915832; PMCID: PMC2751478.
  268. 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.
  269. Kesselheim AS and Avorn J. The role of litigation in drug safety. Journal of the American Medical Association. 2007; 297(3):308-311.
  270. 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.
  271. Kesselheim AS, Mello MM. Medical process patents – monopolizing the delivery of health care. New England Journal of Medicine. 2006; 355(19):2036-2041.
  272. 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.
  273. 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.
    View in: PubMed
  274. 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.
  275. 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.
  276. 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.
    View in: PubMed
  277. 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.
  278. 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.
    View in: PubMed
  279. 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.
  280. Kesselheim AS and Avorn J. Biotechnology products and university-based science. Journal of the American Medical Association. 2005; 293(23):2863.
  281. Kesselheim AS and Brennan TA. Overbilling vs. downcoding — the battle between physicians and insurers. New England Journal of Medicine. 2005; 352(9):855-857.
  282. 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.
  283. 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.
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  284. Kesselheim AS. Patents and intellectual property in medicine. Legal Medicine. 2004; 207-213.
  285. Kesselheim AS. Perspectives: ode to a short white coat. Pharos. 2003; 66:35.
  286. 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.
  287. Kissick WL and Kesselheim AS. Presidential disability: the panel of physicians. Transactions & Studies of the College of Physicians of Philadelphia. 2001; 23:113-119.
  288. Kesselheim AS. Deception and presidential disability: an historical analysis. Trans Stud Coll Physicians Phila. 2001 Dec; 23:87-98. PMID: 12087853.
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  289. 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.
  290. 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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