View recent articles by topic below -- Click PMID links for abstract
DRUG Costs and value
Feldman WB, Avorn J, Kesselheim AS.
Potential Medicare Savings on Inhaler Prescriptions Through the Use of Negotiated Prices and a Defined Formulary.
JAMA Intern Med. [Epub 2019 Dec 2].
PMID: 31790541
Fralick M, Kesselheim AS.
The U.S. Insulin Crisis - Rationing a Lifesaving Medication Discovered in the 1920s.
N Engl J Med. 2019 Nov 7.
PMID: 31693804
Luo J, Kulldorff M, Sarpatwari A, Pawar A, Kesselheim AS.
Variation in Prescription Drug Prices by Retail Pharmacy Type: A National Cross-sectional Study.
Ann Intern Med. [Epub 2019 Oct 1].
PMID: 31569218
Growdon ME, Sacks CA, Kesselheim AS, Avorn J.
Potential Medicare Savings From Generic Substitution and Therapeutic Interchange of ACE Inhibitors and Angiotensin-II-Receptor Blockers.
JAMA Intern Med. [Epub 2019 Aug 5].
PMID: 31380893
Dave CV, Brill G, Kesselheim AS.
Changes in Price for Generic Drugs in the USA, 2008-2016.
J Gen Intern Med. 2019 Sep.
PMID: 31065948
Tessema FA, Kesselheim AS, Sinha MS.
Generic But Expensive: Why Prices Can Remain High for Off-Patent Drugs.
Hastings Law J. [Epub 2019 Aug 21]
Sarpatwari A, DiBello J, Zakarian M, Najafzadeh M, Kesselheim AS.
Competition and price among brand-name drugs in the same class: A systematic review of the evidence.
PLoS Med. 2019 Jul 30.
PMID: 31361747
Li DG, Najafzadeh M, Kesselheim AS, Mostaghimi A.
Spending on World Health Organization essential medicines in Medicare Part D, 2011-15: retrospective cost analysis.
BMJ. 2019 Jul 17.
PMID: 31315833
Hwang TJ, Dusetzina SB, Feng J, Maini L, Kesselheim AS.
Price Increases of Protected-Class Drugs in Medicare Part D, Relative to Inflation, 2012-2017.
JAMA. 2019 Jul 16.
PMID: 31310287
Bourgeois FT, Graham DA, Kesselheim AS, Randolph AG.
Cost Implications of Escalating Intravenous Acetaminophen Use in Children.
JAMA Pediatr. 2019 May 1.
PMID: 30855654
Darrow JJ.
Luxturna: FDA documents reveal the value of a costly gene therapy.
Drug Discov Today. 2019 Apr. [Epub 2019 Jan 31]
PMID: 30711576
Fralick M, Sacks CA, Kesselheim AS.
Assessment of Use of Combined Dextromethorphan and Quinidine in Patients With Dementia or Parkinson Disease After US Food and Drug Administration Approval for Pseudobulbar Affect.
JAMA Intern Med. 2019 Feb 1. [Epub 2019 Jan 7].
PMID: 30615021
Herkert D, Vijayakumar P, Luo J, Schwartz JI, Rabin TL, DeFilippo E, Lipska KJ.
Cost-Related Insulin Underuse Among Patients With Diabetes.
JAMA Intern Med. 2019 Jan 1. [Epub 2018 Dec 3].
PMID: 30508012.
Hernandez I, Sampathkumar S, Good CB, Kesselheim AS, Shrank WH.
Changes in Drug Pricing After Drug Shortages in the United States.
Ann Intern Med. 2019 Jan 1. [Epub 2018 Sep 18].
PMID: 30242373.
Dave CV, Pawar A, Fox ER, Brill G, Kesselheim AS.
Predictors of Drug Shortages and Association with Generic Drug Prices: A Retrospective Cohort Study.
Value Health. 2018 Nov. [Epub 2018 May 18].
PMID: 30442275.
Sacks CA, Lee CC, Kesselheim AS, Avorn J.
Medicare Spending on Brand-name Combination Medications vs Their Generic Constituents.
JAMA. 2018 Aug 21.
PMID: 30140875.
Luo J, Kesselheim AS.
Delayed Generic Market Saturation After Patent Expiration-A Billion-Dollar Problem.
JAMA Intern Med. 2018 May 1.
PMID: 29801126.
Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS.
Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.
BMJ. 2018 Mar 19.
PMID: 29555641.
Powers JH, Evans SR, Kesselheim AS.
Studying new antibiotics for multidrug resistant infections: are today's patients paying for unproved future benefits?
BMJ. 2018 Feb 22.
PMID: 29472192.
Dave CV, Hartzema A, Kesselheim AS.
Prices of Generic Drugs Associated with Numbers of Manufacturers.
N Engl J Med. 2017 Dec 28.
PMID: 29281576.
Tessema FA, Darrow JJ.
A New Approach to Treat Childhood Leukemia: Novartis' CAR-T Therapy.
J Law Med Ethics. 2017 Dec.
PMID: 30027797.
Alpern JD, Zhang L, Stauffer WM, Kesselheim AS.
Trends in Pricing and Generic Competition Within the Oral Antibiotic Drug Market in the United States.
Clin Infect Dis. 2017 Nov 13.
PMID: 29020146.
Vokinger KN, Kesselheim AS, Avorn J, Sarpatwari A.
Strategies That Delay Market Entry of Generic Drugs.
JAMA Intern Med. 2017 Nov 1. [Epub 2017 Sep 18].
PMID: 28975217.
Kesselheim AS, Sinha MS, Avorn J.
Determinants of Market Exclusivity for Prescription Drugs in the United States.
JAMA Intern Med. 2017 Nov 1. [Epub 2017 Sep 11].
PMID: 28892528.
Hwang TJ, Kesselheim AS, Sarpatwari A.
Value-Based Pricing and State Reform of Prescription Drug Costs.
JAMA. 2017 Aug 15. [Epub 2017 Jul 10].
PMID: 28692713.
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 1. [Epub 2017 Jul 4].
PMID: 28672324.
Fralick M, Avorn J, Kesselheim AS.
The Price of Crossing the Border for Medications.
N Engl J Med. 2017 Jul 27.
PMID: 28745989.
Chen CT, Kesselheim AS.
Journey of Generic Imatinib: A Case Study in Oncology Drug Pricing.
J Oncol Pract. 2017 Jun.
PMID: 28445102.
Gellad WF, Kesselheim AS.
Accelerated Approval and Expensive Drugs--A Challenging Combination.
N Engl J Med. 2017 May 25.
PMID: 28538133.
Hwang TJ, Kesselheim AS.
Taxing Drug Price Spikes: Assessing the Potential Impact.
Health Affairs Blog. 2017 May.
Sacks CA, Avorn J, Kesselheim AS.
The Failure of Solanezumab - How the FDA Saved Taxpayers Billions.
N Engl J Med. 2017 May 4.
PMID: 28467878.
Luo J, Kesselheim AS, Avorn J.
Medicaid Expenditures and Estimated Rebates for Epinephrine Autoinjectors, 2012 to 2016.
JAMA Intern Med. 2017 May 1. [Epub 2017 Mar 27].
PMID: 28346577.
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.
PMID: 28402764.
Luo J, Kesselheim AS, Greene J, Lipska KJ.
Strategies to Improve the Afforability of Insulin in the USA.
Lancet Diabetes Endocrinol. 2017 Mar. [Epub 2017 Feb 8].
PMID: 28189654.
Gupta R, Kesselheim AS, Ross JS.
Prioritization of Generic Drug Review-Reply.
JAMA Intern Med. 2017 Jan 1.
PMID: 28030736.
Sarpatwari A, Avorn J, Kesselheim AS.
Factors Influencing Prescription Drug Costs in the United States-Reply.
JAMA. 2016 Dec 13.
PMID: 27959994.
Kesselheim AS, Gagne JJ.
Prescription Trends-Brand-Name Drugs vs Generic-Reply.
JAMA Intern Med. 2016 Oct 1.
PMID: 27695842.
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 1.
PMID: 27367749.
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.
PMID: 27552619.
Sarpatwari A, Kesselheim AS.
Navigating the Dermatological Drug Cost Curve.
JAMA. 2016 Jun 28.
PMID: 27367767.
Sarpatwari A, Avorn J, Kesselheim AS.
State Initiatives to Control Medication Costs--Can Transparency Legislation Help?
N Engl J Med. 2016 Jun 16.
PMID: 27305189.
Engelberg AB, Kesselheim AS.
Use the Bayh-Dole Act to lower drug prices for government healthcare programs.
Nature Medicine. 2016 Jun 7.
PMID: 27270771.
Luo J, Avorn J, Kesselheim AS.
Inaccurate Reporting of Insulin Reimbursement-Reply.
JAMA Intern Med. 2016 Mar.
PMID: 26954041.
Luo J, Kesselheim AS.
Cost-effectiveness of Statin Therapy for ASCVD.
JAMA. 2015 Nov 24.
PMID: 26599189.
Luo J, Sarpatwari A, Kesselheim AS.
Regulatory Solutions to the Problem of High Generic Drug Costs.
Open Forum Infect Dis. 2015 Nov 13.
PMID: 26693494.
Luo J, Avorn J, Kesselheim AS.
Trends in Medicaid Reimbursements for Insulin From 1991 Through 2014.
JAMA Intern Med. 2015 Oct.
PMID: 26301721.
Lewey J, Shrank WH, Avorn J, Liu J, Choudhry NK.
Medication adherence and healthcare disparities: impact of statin co-payment reduction.
Am Journal Manag Care. 2015 Oct.
PMID: 26633094.
Avorn J.
The $2.6 billion pill--methodologic and policy considerations.
New Engl J Med. 2015 May 14.
PMID: 25970049.
Ito K, Avorn J, Shrank WH, Toscano M, Spettel C, Brennan T, Choudhry NK.
Long-term cost-effectiveness of providing full coverage for preventive medications after myocardial infarction.
Circ Cardiovasc Qual Outcomes. 2015 May.
PMID: 25944633.
Sarpatwari A, Kesselheim AS.
Ensuring Timely Approval of Generic Drugs.
Health Affairs Blog. 2015 Mar 24.
Najafzadeh M, Andersson K, Shrank WH, Krumme AA, Matlin OS, Brennan T, Avorn J, Choudhry NK.
Cost-effectiveness of novel regimens for the treatment of hepatitis C virus.
Ann Intern Med. 2015 Mar 17.
PMID: 25775313.
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 17.
PMID: 25781468
Potential Medicare Savings on Inhaler Prescriptions Through the Use of Negotiated Prices and a Defined Formulary.
JAMA Intern Med. [Epub 2019 Dec 2].
PMID: 31790541
Fralick M, Kesselheim AS.
The U.S. Insulin Crisis - Rationing a Lifesaving Medication Discovered in the 1920s.
N Engl J Med. 2019 Nov 7.
PMID: 31693804
Luo J, Kulldorff M, Sarpatwari A, Pawar A, Kesselheim AS.
Variation in Prescription Drug Prices by Retail Pharmacy Type: A National Cross-sectional Study.
Ann Intern Med. [Epub 2019 Oct 1].
PMID: 31569218
Growdon ME, Sacks CA, Kesselheim AS, Avorn J.
Potential Medicare Savings From Generic Substitution and Therapeutic Interchange of ACE Inhibitors and Angiotensin-II-Receptor Blockers.
JAMA Intern Med. [Epub 2019 Aug 5].
PMID: 31380893
Dave CV, Brill G, Kesselheim AS.
Changes in Price for Generic Drugs in the USA, 2008-2016.
J Gen Intern Med. 2019 Sep.
PMID: 31065948
Tessema FA, Kesselheim AS, Sinha MS.
Generic But Expensive: Why Prices Can Remain High for Off-Patent Drugs.
Hastings Law J. [Epub 2019 Aug 21]
Sarpatwari A, DiBello J, Zakarian M, Najafzadeh M, Kesselheim AS.
Competition and price among brand-name drugs in the same class: A systematic review of the evidence.
PLoS Med. 2019 Jul 30.
PMID: 31361747
Li DG, Najafzadeh M, Kesselheim AS, Mostaghimi A.
Spending on World Health Organization essential medicines in Medicare Part D, 2011-15: retrospective cost analysis.
BMJ. 2019 Jul 17.
PMID: 31315833
Hwang TJ, Dusetzina SB, Feng J, Maini L, Kesselheim AS.
Price Increases of Protected-Class Drugs in Medicare Part D, Relative to Inflation, 2012-2017.
JAMA. 2019 Jul 16.
PMID: 31310287
Bourgeois FT, Graham DA, Kesselheim AS, Randolph AG.
Cost Implications of Escalating Intravenous Acetaminophen Use in Children.
JAMA Pediatr. 2019 May 1.
PMID: 30855654
Darrow JJ.
Luxturna: FDA documents reveal the value of a costly gene therapy.
Drug Discov Today. 2019 Apr. [Epub 2019 Jan 31]
PMID: 30711576
Fralick M, Sacks CA, Kesselheim AS.
Assessment of Use of Combined Dextromethorphan and Quinidine in Patients With Dementia or Parkinson Disease After US Food and Drug Administration Approval for Pseudobulbar Affect.
JAMA Intern Med. 2019 Feb 1. [Epub 2019 Jan 7].
PMID: 30615021
Herkert D, Vijayakumar P, Luo J, Schwartz JI, Rabin TL, DeFilippo E, Lipska KJ.
Cost-Related Insulin Underuse Among Patients With Diabetes.
JAMA Intern Med. 2019 Jan 1. [Epub 2018 Dec 3].
PMID: 30508012.
Hernandez I, Sampathkumar S, Good CB, Kesselheim AS, Shrank WH.
Changes in Drug Pricing After Drug Shortages in the United States.
Ann Intern Med. 2019 Jan 1. [Epub 2018 Sep 18].
PMID: 30242373.
Dave CV, Pawar A, Fox ER, Brill G, Kesselheim AS.
Predictors of Drug Shortages and Association with Generic Drug Prices: A Retrospective Cohort Study.
Value Health. 2018 Nov. [Epub 2018 May 18].
PMID: 30442275.
Sacks CA, Lee CC, Kesselheim AS, Avorn J.
Medicare Spending on Brand-name Combination Medications vs Their Generic Constituents.
JAMA. 2018 Aug 21.
PMID: 30140875.
Luo J, Kesselheim AS.
Delayed Generic Market Saturation After Patent Expiration-A Billion-Dollar Problem.
JAMA Intern Med. 2018 May 1.
PMID: 29801126.
Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS.
Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.
BMJ. 2018 Mar 19.
PMID: 29555641.
Powers JH, Evans SR, Kesselheim AS.
Studying new antibiotics for multidrug resistant infections: are today's patients paying for unproved future benefits?
BMJ. 2018 Feb 22.
PMID: 29472192.
Dave CV, Hartzema A, Kesselheim AS.
Prices of Generic Drugs Associated with Numbers of Manufacturers.
N Engl J Med. 2017 Dec 28.
PMID: 29281576.
Tessema FA, Darrow JJ.
A New Approach to Treat Childhood Leukemia: Novartis' CAR-T Therapy.
J Law Med Ethics. 2017 Dec.
PMID: 30027797.
Alpern JD, Zhang L, Stauffer WM, Kesselheim AS.
Trends in Pricing and Generic Competition Within the Oral Antibiotic Drug Market in the United States.
Clin Infect Dis. 2017 Nov 13.
PMID: 29020146.
Vokinger KN, Kesselheim AS, Avorn J, Sarpatwari A.
Strategies That Delay Market Entry of Generic Drugs.
JAMA Intern Med. 2017 Nov 1. [Epub 2017 Sep 18].
PMID: 28975217.
Kesselheim AS, Sinha MS, Avorn J.
Determinants of Market Exclusivity for Prescription Drugs in the United States.
JAMA Intern Med. 2017 Nov 1. [Epub 2017 Sep 11].
PMID: 28892528.
Hwang TJ, Kesselheim AS, Sarpatwari A.
Value-Based Pricing and State Reform of Prescription Drug Costs.
JAMA. 2017 Aug 15. [Epub 2017 Jul 10].
PMID: 28692713.
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 1. [Epub 2017 Jul 4].
PMID: 28672324.
Fralick M, Avorn J, Kesselheim AS.
The Price of Crossing the Border for Medications.
N Engl J Med. 2017 Jul 27.
PMID: 28745989.
Chen CT, Kesselheim AS.
Journey of Generic Imatinib: A Case Study in Oncology Drug Pricing.
J Oncol Pract. 2017 Jun.
PMID: 28445102.
Gellad WF, Kesselheim AS.
Accelerated Approval and Expensive Drugs--A Challenging Combination.
N Engl J Med. 2017 May 25.
PMID: 28538133.
Hwang TJ, Kesselheim AS.
Taxing Drug Price Spikes: Assessing the Potential Impact.
Health Affairs Blog. 2017 May.
Sacks CA, Avorn J, Kesselheim AS.
The Failure of Solanezumab - How the FDA Saved Taxpayers Billions.
N Engl J Med. 2017 May 4.
PMID: 28467878.
Luo J, Kesselheim AS, Avorn J.
Medicaid Expenditures and Estimated Rebates for Epinephrine Autoinjectors, 2012 to 2016.
JAMA Intern Med. 2017 May 1. [Epub 2017 Mar 27].
PMID: 28346577.
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.
PMID: 28402764.
Luo J, Kesselheim AS, Greene J, Lipska KJ.
Strategies to Improve the Afforability of Insulin in the USA.
Lancet Diabetes Endocrinol. 2017 Mar. [Epub 2017 Feb 8].
PMID: 28189654.
Gupta R, Kesselheim AS, Ross JS.
Prioritization of Generic Drug Review-Reply.
JAMA Intern Med. 2017 Jan 1.
PMID: 28030736.
Sarpatwari A, Avorn J, Kesselheim AS.
Factors Influencing Prescription Drug Costs in the United States-Reply.
JAMA. 2016 Dec 13.
PMID: 27959994.
Kesselheim AS, Gagne JJ.
Prescription Trends-Brand-Name Drugs vs Generic-Reply.
JAMA Intern Med. 2016 Oct 1.
PMID: 27695842.
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 1.
PMID: 27367749.
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.
PMID: 27552619.
Sarpatwari A, Kesselheim AS.
Navigating the Dermatological Drug Cost Curve.
JAMA. 2016 Jun 28.
PMID: 27367767.
Sarpatwari A, Avorn J, Kesselheim AS.
State Initiatives to Control Medication Costs--Can Transparency Legislation Help?
N Engl J Med. 2016 Jun 16.
PMID: 27305189.
Engelberg AB, Kesselheim AS.
Use the Bayh-Dole Act to lower drug prices for government healthcare programs.
Nature Medicine. 2016 Jun 7.
PMID: 27270771.
Luo J, Avorn J, Kesselheim AS.
Inaccurate Reporting of Insulin Reimbursement-Reply.
JAMA Intern Med. 2016 Mar.
PMID: 26954041.
Luo J, Kesselheim AS.
Cost-effectiveness of Statin Therapy for ASCVD.
JAMA. 2015 Nov 24.
PMID: 26599189.
Luo J, Sarpatwari A, Kesselheim AS.
Regulatory Solutions to the Problem of High Generic Drug Costs.
Open Forum Infect Dis. 2015 Nov 13.
PMID: 26693494.
Luo J, Avorn J, Kesselheim AS.
Trends in Medicaid Reimbursements for Insulin From 1991 Through 2014.
JAMA Intern Med. 2015 Oct.
PMID: 26301721.
Lewey J, Shrank WH, Avorn J, Liu J, Choudhry NK.
Medication adherence and healthcare disparities: impact of statin co-payment reduction.
Am Journal Manag Care. 2015 Oct.
PMID: 26633094.
Avorn J.
The $2.6 billion pill--methodologic and policy considerations.
New Engl J Med. 2015 May 14.
PMID: 25970049.
Ito K, Avorn J, Shrank WH, Toscano M, Spettel C, Brennan T, Choudhry NK.
Long-term cost-effectiveness of providing full coverage for preventive medications after myocardial infarction.
Circ Cardiovasc Qual Outcomes. 2015 May.
PMID: 25944633.
Sarpatwari A, Kesselheim AS.
Ensuring Timely Approval of Generic Drugs.
Health Affairs Blog. 2015 Mar 24.
Najafzadeh M, Andersson K, Shrank WH, Krumme AA, Matlin OS, Brennan T, Avorn J, Choudhry NK.
Cost-effectiveness of novel regimens for the treatment of hepatitis C virus.
Ann Intern Med. 2015 Mar 17.
PMID: 25775313.
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 17.
PMID: 25781468
Clinical Evidence and Patient Care
Schwartz LM, Woloshin S, Lu Z, Ross KM, Tessema FA, Peter D, Kesselheim AS.
Randomized Study of Providing Evidence Context to Mitigate Physician Misinterpretation Arising From Off-Label Drug Promotion.
Circ Cardiovasc Qual Outcomes. 2019 Nov. [Epub 2019 Nov 11].
PMID: 31707825
Fischer MA, Kesselheim AS, Lu Z, Ross KM, Tessema FA, Avorn J.
Physician Perceptions of Step Therapy Prescribing Requirements.
J Manag Care Spec Pharm. 2019 Nov.
PMID: 31663459
Fralick M, Schneeweiss S, Wallis CJD, Jung EH, Kesselheim AS.
Desmopressin and the risk of hyponatremia: A population-based cohort study.
PLoS Med. 2019 Oct 21.
PMID: 31634354
Hey SP, Gyawali B, D’Andrea E, Kanagaraj M, Franklin JM, Kesselheim AS.
A Systematic Review and Meta-analysis of Bevacizumab in First-line Metastatic Breast Cancer: Lessons for the Research and Regulatory Enterprises.
J Natl Cancer Inst. [Epub 2019 Oct 25].
PMID: 31651981
Fernandez Lynch H, Sarpatwari A, Vonderheide RH, Zettler PJ.
Right to Try Requests and Oncologists’ Gatekeeping Obligations.
J Clin Oncol. [Epub 2019 Oct 15].
PMID: 31613694
Gyawali B, Tessema FA, Jung EH, Kesselheim AS.
Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis.
JAMA Netw Open. 2019 Aug 2.
PMID: 31469391
Gopalakrishnan C, Gagne JJ, Sarpatwari A, Dejene SZ, Dutcher SK, Levin R, Franklin JM, Schneeweiss S, Desai RJ.
Evaluation of Socioeconomic Status Indicators for Confounding Adjustment in Observational Studies of Medication Use.
Clin Pharmacol Ther. 2019 Jun. [Epub 2019 Feb 25].
PMID: 30659590
Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM.
Physicians’ Perspectives on FDA Approval Standards and Off-label Drug Marketing.
JAMA Intern Med. 2019 May 1.
PMID: 30667474
D’Andrea E, Hey SP, Ramirez CL, Kesselheim AS.
Assessment of the Role of Niacin in Managing Cardiovascular Disease Outcomes: A Systematic Review and Meta-analysis.
JAMA Netw Open. 2019 Apr 5.
PMID: 30977858
Hwang TJ, Gyawali B.
Association between progression-free survival and patients' quality of life in cancer clinical trials.
Int J Cancer. 2019 Apr 1. [Epub 2018 Dec 6].
PMID: 30374970.
Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly JG, Fischer MA, Kesselheim AS, Gagne JJ.
Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims.
PLoS Med. 2019 Mar 13.
PMID: 30865626
Sarpatwari A, Gagne JJ, Lu Z, Campbell EG, Carman WJ, Enger CL, Dutcher SK, Jiang W, Kesselheim AS.
A Survey of Patients’ Perceptions of Pill Appearance and Responses to Changes in Appearance for Four Chronic Disease Medications.
J Gen Intern Med. 2019 Mar. [Epub 2019 Jan 10].
PMID: 30632102
Fralick M, Sacks CA, Kesselheim AS.
Assessment of Use of Combined Dextromethorphan and Quinidine in Patients With Dementia or Parkinson Disease After US Food and Drug Administration Approval for Pseudobulbar Affect.
JAMA Intern Med. 2019 Feb 1.
PMID: 30615021
Luo J, Khan NF, Manetti T, Rose J, Kaloghlian A, Gadhe B, Jain SH, Gagne JJ, Kesselheim AS. Implementation of a Health Plan Program for Switching From Analogue to Human Insulin and Glycemic Control Among Medicare Beneficiaries With Type 2 Diabetes.
JAMA. 2019 Jan 29.
PMID: 30694321
Gyawali B, Kesselheim AS, D'Andrea E.
Does Helicobacter pylori eradication therapy to prevent gastric cancer increase all-cause mortality?
Int J Cancer. 2019 Jan 15. [Epub 2018 Oct 26].
PMID: 30152520.
Mundkur ML, Franklin J, Huybrechts KF, Fischer MA, Kesselheim AS, Linder JA, Landon J, Patorno E.
Changes in Outpatient Use of Antibiotics by Adults in the United States, 2006-2015.
Drug Saf. 2018 Dec. [Epub 2018 Jul 9].
PMID: 29987757.
Fralick M, Avorn J, Franklin JM, Bartsch E, Abdurrob A, Kesselheim AS.
Application and Impact of Run-In Studies for the Evaluation of Statin Efficacy and Safety.
J Gen Intern Med. 2018 Jun.
PMID: 29520746.
Sarpatwari A, Lee MP, Gagne JJ, Lu Z, Dutcher SK, JIang W, Campbell EG, Kesselheim AS.
Generic Versions of Narrow Therapeutic Index Drugs: A National Survey of Pharmacists' Substitution Beliefs and Practices.
Clin Pharmacol Ther. 2018 Jun. [Epub 2017 Nov 22].
PMID: 29165800.
Fralick M, Avorn J, Franklin JM, Abdurrob A, Kesselheim AS.
Application and impact of run-in studies.
J Gen Intern Med. 2018 May. [Epub 2018 Feb 15].
PMID: 29450684.
Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly J, Fischer MA, Kesselheim AS, Gagne JJ.
Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study.
BMJ. 2018 Apr 3.
PMID: 29615391.
Avorn J.
The Psychology of Clinical Decision Making - Implications for Medication Use.
N Engl J Med. 2018 Feb 22.
PMID: 29466158.
Hey SP, Weijer C, Taljaard M, Kesselheim AS.
Research ethics for emerging trial designs: does equipoise need to adapt?
BMJ. 2018 Jan 25.
PMID: 29371211.
Avorn J.
Engaging With Patients on Health Policy Changes: An Urgent Issue.
JAMA. 2018 Jan 16.
PMID: 29222542.
Sinha MS, Freifeld CC, Brownstein JS, Donneyong MM, Rausch P, Lappin BM, Zhou EH, Dal Pan GJ, Pawar AM, Hwang TJ, Avorn J, Kesselheim AS.
Social Media Impact of Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis.
JMIR Public Health Surveill. 2018 Jan 5.
PMID: 29305342.
Fralick M, Kesselheim AS, Avorn J, Schneeweiss S.
Use of Health Care Databases to Support Supplemental Indications of Approved Medications.
JAMA Intern Med. 2018 Jan 1.
PMID: 29159410.
Hey SP.
Ethical Challenges in Biomarker-Driven Drug Development.
Clinical Pharmacol Ther. 2018 Jan. [Epub 2017 Sep 25].
PMID: 28944956.
Bothwell LE, Kesselheim AS.
The Real-World Ethics of Adaptive-Design Clinical Trials.
Hastings Cent Rep. 2017 Nov.
PMID: 29171051.
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.
PMID: 28810023.
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. [Epub 2017 May 27].
PMID: 28390139.
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. [Epub 2017 Feb 15].
PMID: 28198116.
Fralick M, Kesselheim AS.
Three design aspects for high quality post-marketing cohort studies.
BMJ. 2017 Apr 12.
PMID: 28404570.
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. [Epub 2017 Jan 24].
PMID: 28116974.
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.
PMID: 28181177.
Youngster I, Avorn J, Belleudi V, Cantarutti A, Díez-Domingo J, Kirchmayer U, Park BJ, Peiró S, Sanfélix-Gimeno G, Schröder H, Schüssel K, Shin JY, Shin SM, Simonsen GS, Blix HS, Tong A, Trifirò G, Ziv-Baran T, Kim SC.
Antibiotic Use in Children - A Cross-National Analysis of 6 Countries.
J Pediatr. 2017 Mar. [Epub 2016 Dec 19].
PMID: 28012694.
Avorn J.
Academic Detailing: "Marketing" the Best Evidence to Clinicians.
JAMA. 2017 Jan 24.
PMID: 28118458.
Deak D, Powers JH, Outterson K, Kesselheim AS.
The Fight Against Multidrug-Resistant Bacteria.
Ann Intern Med. 2017 Jan 3.
PMID: 28030672.
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. [Epub 2016 Nov 17].
PMID: 27866096.
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. [Epub 2016 Sep 28].
PMID: 27683844.
Yeh JS, Franklin JM, Kesselheim AS.
Payments to Physicians, Prescribing Rates, and More Appropriate Conclusions-Reply.
JAMA Intern Med. 2016 Oct 1.
PMID: 27695845.
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 6. [Epub 2016 May 24].
PMID: 27239977.
Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK.
Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naïve women.
Am J Obstet Gynecol. 2016 Sep. [Epub 2016 Mar 17].
PMID: 26996986.
Yeh JS, Sarpatwari A, Kesselheim AS.
Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels.
Drug Saf. 2016 Aug.
PMID: 27000800.
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. [Epub 2016 Apr 22].
PMID: 27102378.
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. [Epub 2016 Feb 16].
PMID: 26883524.
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.
PMID: 27159336.
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.
PMID: 27158897.
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.
PMID: 26662931.
Wu MH, Bartz D, Avorn J, Seeger JD.
Trends in direct-to-consumer advertising of prescription contraceptives.
Contraception. 2016 May. [Epub 2016 Jan 22].
PMID: 26808088.
Baker JA, Avorn J, Levin R, Bateman BT.
Opioid Prescribing After Surgical Extraction of Teeth in Medicaid Patients, 2000-2010.
JAMA. 2016 Apr 19.
PMID: 26978601.
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 Mar 31.
PMID: 27032095.
Beletsky L, Parmet W, Sarpatwari A.
Expanding Coercive Treatment is the Wrong Solution for the Opioid Crisis (Updated).
Health Affairs Blog. 2016 Feb 11.
Lieberman DA, Polinski JM, Choudhry NK, Avorn J, Fischer MA.
Medicaid prescription limits: policy trends and comparative impact on utilization.
BMC Health Serv Res. 2016 Jan 15.
PMID: 26772962.
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. [Epub 2015 Apr 9].
PMID: 25855479.
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.
PMID: 26400844.
Bateman BT, Kesselheim AS.
Propofol as a transformative drug in anesthesia: insights from key early investigators.
Drug Discov Today. 2015 Aug. [Epub 2015 Apr 30].
PMID: 25936833.
Kim SC, Kim MS, Sanfélix-Gimeno G, Song HJ, Liu J, Hurtado I, Peiró S, Lee J, Choi NK, Park BJ, Avorn J.
Use of osteoporosis medications after hospitalization for hip fracture: a cross-national study.
Am J Med. 2015 May. [Epub 2015 Feb 3].
PMID: 25660252.
Bateman BT, Hernandez-Diaz S, Fischer MA, Seely EW, Ecker JL, Franklin JM, Desai RJ, Allen-Coleman C, Mogun H, Avorn J, Huybrechts KF.
Statins and congenital malformations: cohort study.
BMJ. 2015 Mar 17.
PMID: 25784688.
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.
PMID: 25732494.
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. [Epub 2015 Jan 7].
PMID: 25728728.
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.
PMID: 25521879.
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. [Epub 2014 Sep 24].
PMID: 25250724.
Randomized Study of Providing Evidence Context to Mitigate Physician Misinterpretation Arising From Off-Label Drug Promotion.
Circ Cardiovasc Qual Outcomes. 2019 Nov. [Epub 2019 Nov 11].
PMID: 31707825
Fischer MA, Kesselheim AS, Lu Z, Ross KM, Tessema FA, Avorn J.
Physician Perceptions of Step Therapy Prescribing Requirements.
J Manag Care Spec Pharm. 2019 Nov.
PMID: 31663459
Fralick M, Schneeweiss S, Wallis CJD, Jung EH, Kesselheim AS.
Desmopressin and the risk of hyponatremia: A population-based cohort study.
PLoS Med. 2019 Oct 21.
PMID: 31634354
Hey SP, Gyawali B, D’Andrea E, Kanagaraj M, Franklin JM, Kesselheim AS.
A Systematic Review and Meta-analysis of Bevacizumab in First-line Metastatic Breast Cancer: Lessons for the Research and Regulatory Enterprises.
J Natl Cancer Inst. [Epub 2019 Oct 25].
PMID: 31651981
Fernandez Lynch H, Sarpatwari A, Vonderheide RH, Zettler PJ.
Right to Try Requests and Oncologists’ Gatekeeping Obligations.
J Clin Oncol. [Epub 2019 Oct 15].
PMID: 31613694
Gyawali B, Tessema FA, Jung EH, Kesselheim AS.
Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis.
JAMA Netw Open. 2019 Aug 2.
PMID: 31469391
Gopalakrishnan C, Gagne JJ, Sarpatwari A, Dejene SZ, Dutcher SK, Levin R, Franklin JM, Schneeweiss S, Desai RJ.
Evaluation of Socioeconomic Status Indicators for Confounding Adjustment in Observational Studies of Medication Use.
Clin Pharmacol Ther. 2019 Jun. [Epub 2019 Feb 25].
PMID: 30659590
Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM.
Physicians’ Perspectives on FDA Approval Standards and Off-label Drug Marketing.
JAMA Intern Med. 2019 May 1.
PMID: 30667474
D’Andrea E, Hey SP, Ramirez CL, Kesselheim AS.
Assessment of the Role of Niacin in Managing Cardiovascular Disease Outcomes: A Systematic Review and Meta-analysis.
JAMA Netw Open. 2019 Apr 5.
PMID: 30977858
Hwang TJ, Gyawali B.
Association between progression-free survival and patients' quality of life in cancer clinical trials.
Int J Cancer. 2019 Apr 1. [Epub 2018 Dec 6].
PMID: 30374970.
Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly JG, Fischer MA, Kesselheim AS, Gagne JJ.
Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims.
PLoS Med. 2019 Mar 13.
PMID: 30865626
Sarpatwari A, Gagne JJ, Lu Z, Campbell EG, Carman WJ, Enger CL, Dutcher SK, Jiang W, Kesselheim AS.
A Survey of Patients’ Perceptions of Pill Appearance and Responses to Changes in Appearance for Four Chronic Disease Medications.
J Gen Intern Med. 2019 Mar. [Epub 2019 Jan 10].
PMID: 30632102
Fralick M, Sacks CA, Kesselheim AS.
Assessment of Use of Combined Dextromethorphan and Quinidine in Patients With Dementia or Parkinson Disease After US Food and Drug Administration Approval for Pseudobulbar Affect.
JAMA Intern Med. 2019 Feb 1.
PMID: 30615021
Luo J, Khan NF, Manetti T, Rose J, Kaloghlian A, Gadhe B, Jain SH, Gagne JJ, Kesselheim AS. Implementation of a Health Plan Program for Switching From Analogue to Human Insulin and Glycemic Control Among Medicare Beneficiaries With Type 2 Diabetes.
JAMA. 2019 Jan 29.
PMID: 30694321
Gyawali B, Kesselheim AS, D'Andrea E.
Does Helicobacter pylori eradication therapy to prevent gastric cancer increase all-cause mortality?
Int J Cancer. 2019 Jan 15. [Epub 2018 Oct 26].
PMID: 30152520.
Mundkur ML, Franklin J, Huybrechts KF, Fischer MA, Kesselheim AS, Linder JA, Landon J, Patorno E.
Changes in Outpatient Use of Antibiotics by Adults in the United States, 2006-2015.
Drug Saf. 2018 Dec. [Epub 2018 Jul 9].
PMID: 29987757.
Fralick M, Avorn J, Franklin JM, Bartsch E, Abdurrob A, Kesselheim AS.
Application and Impact of Run-In Studies for the Evaluation of Statin Efficacy and Safety.
J Gen Intern Med. 2018 Jun.
PMID: 29520746.
Sarpatwari A, Lee MP, Gagne JJ, Lu Z, Dutcher SK, JIang W, Campbell EG, Kesselheim AS.
Generic Versions of Narrow Therapeutic Index Drugs: A National Survey of Pharmacists' Substitution Beliefs and Practices.
Clin Pharmacol Ther. 2018 Jun. [Epub 2017 Nov 22].
PMID: 29165800.
Fralick M, Avorn J, Franklin JM, Abdurrob A, Kesselheim AS.
Application and impact of run-in studies.
J Gen Intern Med. 2018 May. [Epub 2018 Feb 15].
PMID: 29450684.
Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly J, Fischer MA, Kesselheim AS, Gagne JJ.
Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study.
BMJ. 2018 Apr 3.
PMID: 29615391.
Avorn J.
The Psychology of Clinical Decision Making - Implications for Medication Use.
N Engl J Med. 2018 Feb 22.
PMID: 29466158.
Hey SP, Weijer C, Taljaard M, Kesselheim AS.
Research ethics for emerging trial designs: does equipoise need to adapt?
BMJ. 2018 Jan 25.
PMID: 29371211.
Avorn J.
Engaging With Patients on Health Policy Changes: An Urgent Issue.
JAMA. 2018 Jan 16.
PMID: 29222542.
Sinha MS, Freifeld CC, Brownstein JS, Donneyong MM, Rausch P, Lappin BM, Zhou EH, Dal Pan GJ, Pawar AM, Hwang TJ, Avorn J, Kesselheim AS.
Social Media Impact of Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis.
JMIR Public Health Surveill. 2018 Jan 5.
PMID: 29305342.
Fralick M, Kesselheim AS, Avorn J, Schneeweiss S.
Use of Health Care Databases to Support Supplemental Indications of Approved Medications.
JAMA Intern Med. 2018 Jan 1.
PMID: 29159410.
Hey SP.
Ethical Challenges in Biomarker-Driven Drug Development.
Clinical Pharmacol Ther. 2018 Jan. [Epub 2017 Sep 25].
PMID: 28944956.
Bothwell LE, Kesselheim AS.
The Real-World Ethics of Adaptive-Design Clinical Trials.
Hastings Cent Rep. 2017 Nov.
PMID: 29171051.
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.
PMID: 28810023.
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. [Epub 2017 May 27].
PMID: 28390139.
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. [Epub 2017 Feb 15].
PMID: 28198116.
Fralick M, Kesselheim AS.
Three design aspects for high quality post-marketing cohort studies.
BMJ. 2017 Apr 12.
PMID: 28404570.
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. [Epub 2017 Jan 24].
PMID: 28116974.
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.
PMID: 28181177.
Youngster I, Avorn J, Belleudi V, Cantarutti A, Díez-Domingo J, Kirchmayer U, Park BJ, Peiró S, Sanfélix-Gimeno G, Schröder H, Schüssel K, Shin JY, Shin SM, Simonsen GS, Blix HS, Tong A, Trifirò G, Ziv-Baran T, Kim SC.
Antibiotic Use in Children - A Cross-National Analysis of 6 Countries.
J Pediatr. 2017 Mar. [Epub 2016 Dec 19].
PMID: 28012694.
Avorn J.
Academic Detailing: "Marketing" the Best Evidence to Clinicians.
JAMA. 2017 Jan 24.
PMID: 28118458.
Deak D, Powers JH, Outterson K, Kesselheim AS.
The Fight Against Multidrug-Resistant Bacteria.
Ann Intern Med. 2017 Jan 3.
PMID: 28030672.
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. [Epub 2016 Nov 17].
PMID: 27866096.
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. [Epub 2016 Sep 28].
PMID: 27683844.
Yeh JS, Franklin JM, Kesselheim AS.
Payments to Physicians, Prescribing Rates, and More Appropriate Conclusions-Reply.
JAMA Intern Med. 2016 Oct 1.
PMID: 27695845.
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 6. [Epub 2016 May 24].
PMID: 27239977.
Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK.
Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naïve women.
Am J Obstet Gynecol. 2016 Sep. [Epub 2016 Mar 17].
PMID: 26996986.
Yeh JS, Sarpatwari A, Kesselheim AS.
Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels.
Drug Saf. 2016 Aug.
PMID: 27000800.
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. [Epub 2016 Apr 22].
PMID: 27102378.
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. [Epub 2016 Feb 16].
PMID: 26883524.
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.
PMID: 27159336.
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.
PMID: 27158897.
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.
PMID: 26662931.
Wu MH, Bartz D, Avorn J, Seeger JD.
Trends in direct-to-consumer advertising of prescription contraceptives.
Contraception. 2016 May. [Epub 2016 Jan 22].
PMID: 26808088.
Baker JA, Avorn J, Levin R, Bateman BT.
Opioid Prescribing After Surgical Extraction of Teeth in Medicaid Patients, 2000-2010.
JAMA. 2016 Apr 19.
PMID: 26978601.
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 Mar 31.
PMID: 27032095.
Beletsky L, Parmet W, Sarpatwari A.
Expanding Coercive Treatment is the Wrong Solution for the Opioid Crisis (Updated).
Health Affairs Blog. 2016 Feb 11.
Lieberman DA, Polinski JM, Choudhry NK, Avorn J, Fischer MA.
Medicaid prescription limits: policy trends and comparative impact on utilization.
BMC Health Serv Res. 2016 Jan 15.
PMID: 26772962.
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. [Epub 2015 Apr 9].
PMID: 25855479.
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.
PMID: 26400844.
Bateman BT, Kesselheim AS.
Propofol as a transformative drug in anesthesia: insights from key early investigators.
Drug Discov Today. 2015 Aug. [Epub 2015 Apr 30].
PMID: 25936833.
Kim SC, Kim MS, Sanfélix-Gimeno G, Song HJ, Liu J, Hurtado I, Peiró S, Lee J, Choi NK, Park BJ, Avorn J.
Use of osteoporosis medications after hospitalization for hip fracture: a cross-national study.
Am J Med. 2015 May. [Epub 2015 Feb 3].
PMID: 25660252.
Bateman BT, Hernandez-Diaz S, Fischer MA, Seely EW, Ecker JL, Franklin JM, Desai RJ, Allen-Coleman C, Mogun H, Avorn J, Huybrechts KF.
Statins and congenital malformations: cohort study.
BMJ. 2015 Mar 17.
PMID: 25784688.
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.
PMID: 25732494.
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. [Epub 2015 Jan 7].
PMID: 25728728.
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.
PMID: 25521879.
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. [Epub 2014 Sep 24].
PMID: 25250724.
PHARMACEUTICAL Innovation
Hwang TJ, Sinha MS, Dave CV, Kesselheim AS.
Prescription Opioid Epidemic and Trends in the Clinical Development of New Pain Medications. Mayo Clin Proc. 2019 Dec 9. [Epub 2019 Nov 2].
PMID: 31685265
Nayak RK, Avorn J, Kesselheim AS.
Public sector financial support for late stage discovery of new drugs in the United States: cohort study.
BMJ. 2019 Oct 23.
PMID: 31645328
Gyawali B, Bouche G, Pantziarka P, Kesselheim AS, Sarpatwari A.
Lung Cancer Survival Gains: Contributions of Academia and Industry.
J Law Med Ethics. 2019 Sep.
PMID: 31560624
Zhai MZ, Sarpatwari A, Kesselheim AS.
Why Are Biosimilars Not Living up to Their Promise in the US?
AMA J Ethics. 2019 Aug 1.
PMID: 31397662
Vokinger KN, Kesselheim AS.
Characteristics of trials and regulatory pathways leading to US approval of innovative vs. non-innovative oncology drugs.
Health Policy. 2019 Aug. [Epub 2019 Jun 12].
PMID: 31229275
Rex JH, Fernandez Lynch H, Cohen IG, Darrow JJ, Outterson K.
Designing development programs for non-traditional antibacterial agents.
Nat Commun. 2019 Jul 31.
PMID: 31366924
Gyawali B, Hey SP, Kesselheim AS.
Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.
JAMA Intern Med. 2019 Jul 1.
PMID: 31135808
Beall RF, Hwang TJ, Kesselheim AS.
Pre-market development times for biologic versus small-molecule drugs.
Nat Biotechnol. 2019 Jul.
PMID: 31213674
Gyawali B, Kesselheim AS.
The promise of ESCAT: a new system for evaluating cancer drug-target pairs.
Nat Rev Clin Oncol. 2019 Mar. [Epub 2018 Oct 13].
PMID: 30317250.
Hwang TJ, Bourgeois FT, Franklin JM, Kesselheim AS.
Impact Of The Priority Review Voucher Program On Drug Development For Rare Pediatric Diseases.
Health Aff (Millwood). 2019 Feb.
PMID: 30715972
Gyawali B, Kesselheim AS.
Reinforcing the social compromise of accelerated approval.
Nat Rev Clin Oncol. 2018 Oct.
PMID: 29970919.
Sarpatwari A, Lee MP, Gagne JJ, Lu Z, Dutcher SK, Jiang W, Campbell EG, Kesselheim AS.
Generic Versions of Narrow Therapeutic Index Drugs: A National Survey of Pharmacists' Substitution Beliefs and Practices.
Clin Pharmacol Ther. 2018 Jun. [Epub 2017 Nov 22].
PMID: 29165800.
Hwang TJ, Franklin JM, Chen CT, Lauffenburger JC, Gyawali B, Kesselheim AS, Darrow JJ.
Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines.
J Clin Oncol. 2018 Jun 20. [Epub 2018 Apr 24].
PMID: 29688832.
Sinha MS, Jain N, Hwang T, Kesselheim AS.
Expansion of the Priority Review Voucher Program Under the 21st Century Cures Act: Implications for Innovation and Public Health.
Am J Law Med. 2018 May.
PMID: 30106661.
Pregelj L, Hwang TJ, Hine DC, Siegel EB, Barnard RT, Darrow JJ, Kesselheim AS.
Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines.
Health Aff (Millwood). 2018 May.
PMID: 29733717.
Bothwell LE, Avorn J, Khan NF, Kesselheim AS.
Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov.
BMJ Open. 2018 Feb 10.
PMID: 29440155.
Hwang TJ, Darrow JJ, Kesselheim AS.
The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016.
JAMA. 2017 Dec 5.
PMID: 29209711.
Hwang TJ, Kesselheim AS.
Challenges in the Development of Novel Cardiovascular Therapies.
Clin Pharmacol Ther. 2017 Aug. [Epub 2017 Jun 23].
PMID: 28643861.
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.
PMID: 28611186.
Hey SP, Kesselheim AS.
Reprioritizing Research Activity for the Post-Antibiotic Era: Ethical, Legal, and Social Considerations.
Hastings Cent Report. 2017 Mar.
PMID: 28301705.
Kesselheim AS, Hey SP, Deak D, Lo B
Four Ways to Address the Ethical Tensions around Expedited Approval of New Prescription Drugs.
Health Affairs Blog. 2016 Jun 23
Caplan ES, Kesselheim AS.
Anti-VEGF therapy in ophthalmology: a qualitative analysis of transformative drug development.
Drug Discov Today. 2016 Jun. [Epub 2016 May 7].
PMID: 27167328.
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.
PMID: 26858373.
Kesselheim AS, Hwang TJ, Franklin JM.
Two decades of new drug development for central nervous system disorders.
Nat Rev Drug Discov. 2015 Dec. [Epub 2015 Nov 20].
PMID: 26585536.
Hwang TJ, Powers JH, Carpenter D, Kesselheim AS.
Accelerating innovation in rapid diagnostics and targeted antibacterials.
Nat Biotechnol. 2015 Jun.
PMID: 26057972.
Kesselheim AS, Sarpatwari A.
To Spur Medical Innovation, Make Corporate Cheaters Pay.
Health Affairs Blog. 2015 Apr 30.
Hwang TJ, Carpenter D, Kesselheim AS.
Paying for innovation: reimbursement incentives for antibiotics.
Sci Transl Med. 2015 Feb 25.
PMID: 25717095.
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.
PMID: 25646109.
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.
PMID: 25362528.
Prescription Opioid Epidemic and Trends in the Clinical Development of New Pain Medications. Mayo Clin Proc. 2019 Dec 9. [Epub 2019 Nov 2].
PMID: 31685265
Nayak RK, Avorn J, Kesselheim AS.
Public sector financial support for late stage discovery of new drugs in the United States: cohort study.
BMJ. 2019 Oct 23.
PMID: 31645328
Gyawali B, Bouche G, Pantziarka P, Kesselheim AS, Sarpatwari A.
Lung Cancer Survival Gains: Contributions of Academia and Industry.
J Law Med Ethics. 2019 Sep.
PMID: 31560624
Zhai MZ, Sarpatwari A, Kesselheim AS.
Why Are Biosimilars Not Living up to Their Promise in the US?
AMA J Ethics. 2019 Aug 1.
PMID: 31397662
Vokinger KN, Kesselheim AS.
Characteristics of trials and regulatory pathways leading to US approval of innovative vs. non-innovative oncology drugs.
Health Policy. 2019 Aug. [Epub 2019 Jun 12].
PMID: 31229275
Rex JH, Fernandez Lynch H, Cohen IG, Darrow JJ, Outterson K.
Designing development programs for non-traditional antibacterial agents.
Nat Commun. 2019 Jul 31.
PMID: 31366924
Gyawali B, Hey SP, Kesselheim AS.
Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.
JAMA Intern Med. 2019 Jul 1.
PMID: 31135808
Beall RF, Hwang TJ, Kesselheim AS.
Pre-market development times for biologic versus small-molecule drugs.
Nat Biotechnol. 2019 Jul.
PMID: 31213674
Gyawali B, Kesselheim AS.
The promise of ESCAT: a new system for evaluating cancer drug-target pairs.
Nat Rev Clin Oncol. 2019 Mar. [Epub 2018 Oct 13].
PMID: 30317250.
Hwang TJ, Bourgeois FT, Franklin JM, Kesselheim AS.
Impact Of The Priority Review Voucher Program On Drug Development For Rare Pediatric Diseases.
Health Aff (Millwood). 2019 Feb.
PMID: 30715972
Gyawali B, Kesselheim AS.
Reinforcing the social compromise of accelerated approval.
Nat Rev Clin Oncol. 2018 Oct.
PMID: 29970919.
Sarpatwari A, Lee MP, Gagne JJ, Lu Z, Dutcher SK, Jiang W, Campbell EG, Kesselheim AS.
Generic Versions of Narrow Therapeutic Index Drugs: A National Survey of Pharmacists' Substitution Beliefs and Practices.
Clin Pharmacol Ther. 2018 Jun. [Epub 2017 Nov 22].
PMID: 29165800.
Hwang TJ, Franklin JM, Chen CT, Lauffenburger JC, Gyawali B, Kesselheim AS, Darrow JJ.
Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines.
J Clin Oncol. 2018 Jun 20. [Epub 2018 Apr 24].
PMID: 29688832.
Sinha MS, Jain N, Hwang T, Kesselheim AS.
Expansion of the Priority Review Voucher Program Under the 21st Century Cures Act: Implications for Innovation and Public Health.
Am J Law Med. 2018 May.
PMID: 30106661.
Pregelj L, Hwang TJ, Hine DC, Siegel EB, Barnard RT, Darrow JJ, Kesselheim AS.
Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines.
Health Aff (Millwood). 2018 May.
PMID: 29733717.
Bothwell LE, Avorn J, Khan NF, Kesselheim AS.
Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov.
BMJ Open. 2018 Feb 10.
PMID: 29440155.
Hwang TJ, Darrow JJ, Kesselheim AS.
The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016.
JAMA. 2017 Dec 5.
PMID: 29209711.
Hwang TJ, Kesselheim AS.
Challenges in the Development of Novel Cardiovascular Therapies.
Clin Pharmacol Ther. 2017 Aug. [Epub 2017 Jun 23].
PMID: 28643861.
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.
PMID: 28611186.
Hey SP, Kesselheim AS.
Reprioritizing Research Activity for the Post-Antibiotic Era: Ethical, Legal, and Social Considerations.
Hastings Cent Report. 2017 Mar.
PMID: 28301705.
Kesselheim AS, Hey SP, Deak D, Lo B
Four Ways to Address the Ethical Tensions around Expedited Approval of New Prescription Drugs.
Health Affairs Blog. 2016 Jun 23
Caplan ES, Kesselheim AS.
Anti-VEGF therapy in ophthalmology: a qualitative analysis of transformative drug development.
Drug Discov Today. 2016 Jun. [Epub 2016 May 7].
PMID: 27167328.
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.
PMID: 26858373.
Kesselheim AS, Hwang TJ, Franklin JM.
Two decades of new drug development for central nervous system disorders.
Nat Rev Drug Discov. 2015 Dec. [Epub 2015 Nov 20].
PMID: 26585536.
Hwang TJ, Powers JH, Carpenter D, Kesselheim AS.
Accelerating innovation in rapid diagnostics and targeted antibacterials.
Nat Biotechnol. 2015 Jun.
PMID: 26057972.
Kesselheim AS, Sarpatwari A.
To Spur Medical Innovation, Make Corporate Cheaters Pay.
Health Affairs Blog. 2015 Apr 30.
Hwang TJ, Carpenter D, Kesselheim AS.
Paying for innovation: reimbursement incentives for antibiotics.
Sci Transl Med. 2015 Feb 25.
PMID: 25717095.
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.
PMID: 25646109.
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.
PMID: 25362528.
DRUG Policy and Legislation
Dave CV, Patorno E, Franklin JM, Huybrechts K, Sarpatwari A, Kesselheim AS, Bateman BT.
Impact of State Laws Restricting Opioid Duration on Characteristics of New Opioid Prescriptions.
J Gen Intern Med. 2019 Nov. [Epub 2019 Jul].
PMID: 31309407
Lee TT, Solomon DH, Kesselheim AS. Fool Me Twice?
The Reemergence of Rofecoxib and the Orphan Drug Act.
Ann Intern Med. [Epub 2019 Oct 1].
PMID: 31569216
Bourgeois FT, Kesselheim AS.
Promoting Pediatric Drug Research and Labeling - Outcomes of Legislation.
N Engl J Med. 2019 Aug 29.
PMID: 31461599
Sarpatwari A, Kesselheim AS.
Reforming the Orphan Drug Act for the 21st Century.
N Engl J Med. 2019 Jul 11.
PMID: 31291512
Stern AD, Pietrulla F, Herr A, Kesselheim AS, Sarpatwari A.
The Impact Of Price Regulation On The Availability Of New Drugs In Germany.
Health Aff (Millwood). 2019 Jul.
PMID: 31260362
Feldman WB, Hey SP, Franklin JM, Kesselheim AS.
Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys.
JAMA Netw Open. 2019 Jul 3.
PMID: 31339546
Bollyky T, Kesselheim AS.
Pharmaceutical Protections in U.S. Trade Deals - What Do Americans Get in Return?
N Engl J Med. 2019 May 23. [Epub 2019 May 1].
PMID: 31042823
Gyawali B, Kesselheim AS.
US Food and Drug Administration Approval of New Drugs Based on Noninferiority Trials in Oncology: A Dangerous Precedent?
JAMA Oncol. 2019 May 1.
PMID: 30920591
Sarpatwari A, Kesselheim AS.
Tepid Steps on Drug Pricing.
JAMA Intern Med. 2019 Mar 1.
PMID: 30667462
Hwang TJ, Jain N, Lauffenburger JC, Vokinger KN, Kesselheim AS.
Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs.
JAMA Intern Med. 2019 Mar 1.
PMID: 30640379
Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM.
Internal Medicine Physicians' Financial Relationships with Industry: An Updated National Estimate.
J Gen Intern Med. 2019 Feb. [Epub 2018 Oct 5]
PMID: 30291605.
Lynch HF, Zettler PJ, Sarpatwari A.
Promoting Patient Interests in Implementing the Federal Right to Try Act.
JAMA. 2018 Sep 4.
PMID: 30105394.
Sinha MS, Kesselheim AS.
The Tax Cuts and Jobs Act of 2017 and the Pharmaceutical Industry.
J Law Med Ethics. 2018 Sep.
PMID: 30336090.
Sarpatwari A, Avorn J, Kesselheim AS.
An Incomplete Prescription: President Trump's Plan to Address High Drug Prices.
JAMA. 2018 Jun 19.
PMID: 29800027.
Sinha MS, Curfman GD, Carrier MA.
Antitrust, Market Exclusivity, and Transparency in the Pharmaceutical Industry.
JAMA. 2018 Jun 12.
PMID: 29801104.
Hey SP, Kesselheim AS.
Defining "True and Non-Misleading" for Pharmaceutical Promotion.
J Law Med Ethics. 2018 Jun.
PMID: 30146990.
Sinha MS, Kesselheim AS.
The next forum for unraveling FDA off-label marketing rules: State and federal legislatures.
PLoS Med. 2018 May 8.
PMID: 29738523.
Sarpatwari A, Beall RF, Abdurrob A, He M, Kesselheim AS.
Evaluating The Impact Of The Orphan Drug Act's Seven-Year Market Exclusivity Period.
Health Aff (Millwood). 2018 May.
PMID: 29733729.
Lee TT, Kesselheim AS, Kapczynski A.
Legal Challenges to State Drug Pricing Laws.
JAMA. 2018 Mar 6.
PMID: 29435585.
Darrow JJ, Fuse Brown EC, Kesselheim AS.
The Regulatory Accountability Act of 2017 - Implications for FDA Regulation and Public Health.
N Engl J Med. 2018 Feb 1. [Epub 2017 Dec 20].
PMID: 29261363.
Sommers BD, Kesselheim AS.
Massachusetts' Proposed Medicaid Reforms - Cheaper Drugs and Better Coverage?
N Engl J Med. 2018 Jan 11. [Epub 2017 Dec 13].
PMID: 29236573.
Fuse Brown EC, Sarpatwari A.
Removing ERISA's Impediment to State Health Reform.
N Engl J Med. 2018 Jan 4.
PMID: 29298152.
Curfman GD, Beletsky L, Sarpatwari A.
Benefits, Limitations, and Value of Abuse-Deterrent Opioids.
JAMA Intern Med. 2018 Jan 1.
PMID: 29228102.
Sarpatwari A, Gluck AR, Curfman GD.
The Supreme Court Ruling in Sandoz v. Amgen: A Victory for Follow-on Biologics.
JAMA Intern Med. 2018 Jan 1.
PMID: 29131908.
Sinha MS, Kesselheim AS, Darrow JJ.
Pharmaceutical Advertising in Medical Journals: Revisiting a Long-Standing Relationship.
Chest. 2018 Jan.
PMID: 29307432.
Darrow JJ, Beall RF, Kesselheim AS.
Will inter partes review speed US generic drug entry?
Nat Biotechnol. 2017 Dec 8.
PMID: 29220017.
Seeley E, Kesselheim AS.
Outcomes-Based Pharmaceutical Contracts: An Answer to High U.S. Drug Spending.
Issue Brief (Commonw Fund). 2017 Sep.
PMID: 28953345.
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 1.
PMID: 28715551.
Sinha MS, Kesselheim AS.
The Effects of the Sunshine Act: What Can and Should We Expect?
Am J Bioeth. 2017 Jun.
PMID: 28537826.
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. [Epub 2017 Jan 24].
PMID: 28116974.
Hey SP, Kesselheim AS.
Reprioritizing Research Activity for the Post-Antibiotic Era: Ethical, Legal, and Social Considerations.
Hastings Cent Rep. 2017 Mar.
PMID: 28301705.
Kesselheim AS, Avorn J.
New "21st Century Cures" Legislation: Speed and Ease vs Science.
JAMA. 2017 Feb 14. [Epub 2017 Jan 5].
PMID: 28056124.
Sinha MS, Sarpatwari A.
The Current 21st Century Cures Legislation is Still a Bad Deal for Patients.
Health Affairs Blog. 2016 Nov 30.
Hwang TJ, Kesselheim AS.
Public referendum on drug prices in the US: will it bring relief?
BMJ. 2016 Oct 31.
PMID: 27799143.
Kimmelman J, Kesselheim AS.
Translational research and the U.S. federal elections.
Sci Transl Med. 2016 Oct 19.
PMID: 27798261.
Hey SP, Kesselheim AS.
BIOMEDICAL RESEARCH. Countering imprecision in precision medicine.
Science. 2016 Jul 29.
PMID: 27471295.
Kesselheim AS, Hwang TJ.
Breakthrough Medical Devices and the 21st Century Cures Act.
Ann Intern Med. 2016 Apr 5. [Epub 2016 Jan 19].
PMID: 26785350.
Avorn J.
The First Amendment and Pharmaceutical Promotion.
Health Affairs Blog 2016 Mar 11
Engelberg A, Avorn J, Kesselheim AS.
Addressing Generic Drug Affordability and Shortages by Globalizing the Market for Old Drugs.
Health Affairs Blog. 2016 Feb 23
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.
Journal Grad Med Educ. 2015 Dec.
PMID: 26692972.
Kesselheim AS, Sinha MS, Joffe S.
Physicians and Insider Trading.
JAMA Intern Med. 2015 Dec.
PMID: 26457747.
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.
PMID: 26626985.
Sarpatwari A, Kesselheim AS.
The 21st century cures act: Opportunities and challenges.
Clinical Pharmacol Ther. 2015 Dec. [Epub 2015 Oct 8].
PMID: 26264909.
Carrier M, Kesselheim AS.
The Daraprim Price Hike and a Role for Antitrust.
Health Affairs Blog. 2015 Oct 21.
Luo J, Kesselheim AS.
The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines.
JAMA. 2015 Oct 20.
PMID: 26291894.
Avorn J.
In Opposition to Liberty: We Need a "Sovereign" to Govern Drug Claims.
Ann Intern Med. 2015 Aug 4.
PMID: 26121615.
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 Summer.
PMID: 26333236.
Avorn J, Kesselheim AS.
The 21st Century Cures Act--Will It Take Us Back in Time?
New Engl J Med. 2015 Jun 25. [Epub 2015 Jun 3].
PMID: 26039522.
Darrow JJ, Sarpatwari A, Avorn J, Kesselheim AS.
Practical, legal, and ethical issues in expanded access to investigational drugs.
New Engl J Med. 2015 Jan 15.
PMID: 25587952.
Impact of State Laws Restricting Opioid Duration on Characteristics of New Opioid Prescriptions.
J Gen Intern Med. 2019 Nov. [Epub 2019 Jul].
PMID: 31309407
Lee TT, Solomon DH, Kesselheim AS. Fool Me Twice?
The Reemergence of Rofecoxib and the Orphan Drug Act.
Ann Intern Med. [Epub 2019 Oct 1].
PMID: 31569216
Bourgeois FT, Kesselheim AS.
Promoting Pediatric Drug Research and Labeling - Outcomes of Legislation.
N Engl J Med. 2019 Aug 29.
PMID: 31461599
Sarpatwari A, Kesselheim AS.
Reforming the Orphan Drug Act for the 21st Century.
N Engl J Med. 2019 Jul 11.
PMID: 31291512
Stern AD, Pietrulla F, Herr A, Kesselheim AS, Sarpatwari A.
The Impact Of Price Regulation On The Availability Of New Drugs In Germany.
Health Aff (Millwood). 2019 Jul.
PMID: 31260362
Feldman WB, Hey SP, Franklin JM, Kesselheim AS.
Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys.
JAMA Netw Open. 2019 Jul 3.
PMID: 31339546
Bollyky T, Kesselheim AS.
Pharmaceutical Protections in U.S. Trade Deals - What Do Americans Get in Return?
N Engl J Med. 2019 May 23. [Epub 2019 May 1].
PMID: 31042823
Gyawali B, Kesselheim AS.
US Food and Drug Administration Approval of New Drugs Based on Noninferiority Trials in Oncology: A Dangerous Precedent?
JAMA Oncol. 2019 May 1.
PMID: 30920591
Sarpatwari A, Kesselheim AS.
Tepid Steps on Drug Pricing.
JAMA Intern Med. 2019 Mar 1.
PMID: 30667462
Hwang TJ, Jain N, Lauffenburger JC, Vokinger KN, Kesselheim AS.
Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs.
JAMA Intern Med. 2019 Mar 1.
PMID: 30640379
Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM.
Internal Medicine Physicians' Financial Relationships with Industry: An Updated National Estimate.
J Gen Intern Med. 2019 Feb. [Epub 2018 Oct 5]
PMID: 30291605.
Lynch HF, Zettler PJ, Sarpatwari A.
Promoting Patient Interests in Implementing the Federal Right to Try Act.
JAMA. 2018 Sep 4.
PMID: 30105394.
Sinha MS, Kesselheim AS.
The Tax Cuts and Jobs Act of 2017 and the Pharmaceutical Industry.
J Law Med Ethics. 2018 Sep.
PMID: 30336090.
Sarpatwari A, Avorn J, Kesselheim AS.
An Incomplete Prescription: President Trump's Plan to Address High Drug Prices.
JAMA. 2018 Jun 19.
PMID: 29800027.
Sinha MS, Curfman GD, Carrier MA.
Antitrust, Market Exclusivity, and Transparency in the Pharmaceutical Industry.
JAMA. 2018 Jun 12.
PMID: 29801104.
Hey SP, Kesselheim AS.
Defining "True and Non-Misleading" for Pharmaceutical Promotion.
J Law Med Ethics. 2018 Jun.
PMID: 30146990.
Sinha MS, Kesselheim AS.
The next forum for unraveling FDA off-label marketing rules: State and federal legislatures.
PLoS Med. 2018 May 8.
PMID: 29738523.
Sarpatwari A, Beall RF, Abdurrob A, He M, Kesselheim AS.
Evaluating The Impact Of The Orphan Drug Act's Seven-Year Market Exclusivity Period.
Health Aff (Millwood). 2018 May.
PMID: 29733729.
Lee TT, Kesselheim AS, Kapczynski A.
Legal Challenges to State Drug Pricing Laws.
JAMA. 2018 Mar 6.
PMID: 29435585.
Darrow JJ, Fuse Brown EC, Kesselheim AS.
The Regulatory Accountability Act of 2017 - Implications for FDA Regulation and Public Health.
N Engl J Med. 2018 Feb 1. [Epub 2017 Dec 20].
PMID: 29261363.
Sommers BD, Kesselheim AS.
Massachusetts' Proposed Medicaid Reforms - Cheaper Drugs and Better Coverage?
N Engl J Med. 2018 Jan 11. [Epub 2017 Dec 13].
PMID: 29236573.
Fuse Brown EC, Sarpatwari A.
Removing ERISA's Impediment to State Health Reform.
N Engl J Med. 2018 Jan 4.
PMID: 29298152.
Curfman GD, Beletsky L, Sarpatwari A.
Benefits, Limitations, and Value of Abuse-Deterrent Opioids.
JAMA Intern Med. 2018 Jan 1.
PMID: 29228102.
Sarpatwari A, Gluck AR, Curfman GD.
The Supreme Court Ruling in Sandoz v. Amgen: A Victory for Follow-on Biologics.
JAMA Intern Med. 2018 Jan 1.
PMID: 29131908.
Sinha MS, Kesselheim AS, Darrow JJ.
Pharmaceutical Advertising in Medical Journals: Revisiting a Long-Standing Relationship.
Chest. 2018 Jan.
PMID: 29307432.
Darrow JJ, Beall RF, Kesselheim AS.
Will inter partes review speed US generic drug entry?
Nat Biotechnol. 2017 Dec 8.
PMID: 29220017.
Seeley E, Kesselheim AS.
Outcomes-Based Pharmaceutical Contracts: An Answer to High U.S. Drug Spending.
Issue Brief (Commonw Fund). 2017 Sep.
PMID: 28953345.
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 1.
PMID: 28715551.
Sinha MS, Kesselheim AS.
The Effects of the Sunshine Act: What Can and Should We Expect?
Am J Bioeth. 2017 Jun.
PMID: 28537826.
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. [Epub 2017 Jan 24].
PMID: 28116974.
Hey SP, Kesselheim AS.
Reprioritizing Research Activity for the Post-Antibiotic Era: Ethical, Legal, and Social Considerations.
Hastings Cent Rep. 2017 Mar.
PMID: 28301705.
Kesselheim AS, Avorn J.
New "21st Century Cures" Legislation: Speed and Ease vs Science.
JAMA. 2017 Feb 14. [Epub 2017 Jan 5].
PMID: 28056124.
Sinha MS, Sarpatwari A.
The Current 21st Century Cures Legislation is Still a Bad Deal for Patients.
Health Affairs Blog. 2016 Nov 30.
Hwang TJ, Kesselheim AS.
Public referendum on drug prices in the US: will it bring relief?
BMJ. 2016 Oct 31.
PMID: 27799143.
Kimmelman J, Kesselheim AS.
Translational research and the U.S. federal elections.
Sci Transl Med. 2016 Oct 19.
PMID: 27798261.
Hey SP, Kesselheim AS.
BIOMEDICAL RESEARCH. Countering imprecision in precision medicine.
Science. 2016 Jul 29.
PMID: 27471295.
Kesselheim AS, Hwang TJ.
Breakthrough Medical Devices and the 21st Century Cures Act.
Ann Intern Med. 2016 Apr 5. [Epub 2016 Jan 19].
PMID: 26785350.
Avorn J.
The First Amendment and Pharmaceutical Promotion.
Health Affairs Blog 2016 Mar 11
Engelberg A, Avorn J, Kesselheim AS.
Addressing Generic Drug Affordability and Shortages by Globalizing the Market for Old Drugs.
Health Affairs Blog. 2016 Feb 23
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.
Journal Grad Med Educ. 2015 Dec.
PMID: 26692972.
Kesselheim AS, Sinha MS, Joffe S.
Physicians and Insider Trading.
JAMA Intern Med. 2015 Dec.
PMID: 26457747.
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.
PMID: 26626985.
Sarpatwari A, Kesselheim AS.
The 21st century cures act: Opportunities and challenges.
Clinical Pharmacol Ther. 2015 Dec. [Epub 2015 Oct 8].
PMID: 26264909.
Carrier M, Kesselheim AS.
The Daraprim Price Hike and a Role for Antitrust.
Health Affairs Blog. 2015 Oct 21.
Luo J, Kesselheim AS.
The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines.
JAMA. 2015 Oct 20.
PMID: 26291894.
Avorn J.
In Opposition to Liberty: We Need a "Sovereign" to Govern Drug Claims.
Ann Intern Med. 2015 Aug 4.
PMID: 26121615.
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 Summer.
PMID: 26333236.
Avorn J, Kesselheim AS.
The 21st Century Cures Act--Will It Take Us Back in Time?
New Engl J Med. 2015 Jun 25. [Epub 2015 Jun 3].
PMID: 26039522.
Darrow JJ, Sarpatwari A, Avorn J, Kesselheim AS.
Practical, legal, and ethical issues in expanded access to investigational drugs.
New Engl J Med. 2015 Jan 15.
PMID: 25587952.
Intellectual Property
Darrow JJ, He M, Stefanini K.
The 505(b)(2) Drug Approval Pathway.
Food Drug Law J. 2019 Dec.
Hong P, Sarpatwari A, Kesselheim AS.
Orphan Drug Designation and Exclusivity for “Same Drugs”.
J Law Med Ethics. 2019 Jun.
PMID: 31298092
Jung EH, Sarpatwari A, Kesselheim AS, Sinha MS.
FDA and EMA Biosimilar Approvals.
J Gen Intern Med. [Epub 2019 May; Repub 2019 Dec 2].
PMID: 31637641
Beall RF, Hwang TJ, Kesselheim AS.
Major Events in the Life Course of New Drugs, 2000-2016.
N Engl J Med. 2019 Mar 14.
PMID: 30865793
Beall RF, Darrow JJ, Kesselheim AS.
Approximating Future Generic Entry for New Drugs.
J Law Med Ethics. 2019 Mar.
PMID: 30994060
Beall RF, Kesselheim AS, Sarpatwari A.
New Drug Formulations and Their Respective Generic Entry Dates.
J Manag Care Spec Pharm. 2019 Feb.
PMID: 30698097
Minssen T, Kesselheim AS, Darrow JJ.
An export-only exception to pharmaceutical patents in Europe: should the United States follow suit?
Nat Biotechnol. 2019 Jan 3.
PMID: 30605154
Gagne JJ, Sarpatwari A, Desai RJ.
Role of Authorized Generics in Postapproval Surveillance of Generic Drug Products.
Clin Pharmacol Ther. 2019 Feb. [Epub Dec 2018].
PMID: 30593655.
Darrow JJ, Beall RF, Kesselheim AS.
The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents.
Appl Health Econ Health Policy. 2019 Feb. [Epub 2018 Aug 24].
PMID: 30141133.
Sarpatwari A, Barenie R, Curfman G, Darrow JJ, Kesselheim AS.
The US Biosimilar Market: Stunted Growth and Possible Reforms.
Clin Pharmacol Ther. 2019 Jan. [Epub 2018 Dec 28].
PMID: 30415479.
Beall RF, Darrow JJ, Kesselheim AS.
Patent term restoration for top-selling drugs in the United States.
Drug Discov Today. 2019 Jan. [Epub 2018 Jul 25].
PMID: 30055271.
Beall RF, Darrow JJ, Kesselheim AS.
A Method for Approximating Future Entry of Generic Drugs.
Value Health. 2018 Dec. [Epub 2018 Jun 11].
PMID: 30502781.
Wang A, Kesselheim AS.
Government Patent Use to Address the Rising Cost of Naloxone: 28 U.S.C. § 1498 and Evzio.
J Law Med Ethics. 2018 Jun.
PMID: 30146993.
Beall RF, Kesselheim AS.
Tertiary patenting on drug-device combination products in the United States.
Nat Biotechnol. 2018 Feb 6;36(2):142-145.
PMID: 29406508.
Kapczynski A, Kesselheim AS
Why 'Government Patent Use' to Lower Drug Costs Won't Stifle Innovation.
Health Affairs Blog. 2016 Jul 28.
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 1.
PMID: 27437823.
Treasure CL, Kesselheim AS.
How Patent Troll Legislation Can Increase Timely Access to Generic Drugs.
JAMA Intern Med. 2016 Jun 1.
PMID: 27183456.
Kapczynski A, Kesselheim AS.
'Government Patent Use': A Legal Approach To Reducing Drug Spending.
Health Aff (Millwood). 2016 May 1.
PMID: 27140984.
Capati VC, Kesselheim AS.
Drug Product Life-Cycle Management as Anticompetitive Behavior: The Case of Memantine.
J Manag Care Spec Pharm. 2016 Apr.
PMID: 27023687.
Sarpatwari A, Kesselheim AS.
The Case for Reforming Drug Naming: Should Brand Name Trademark Protections Expire upon Generic Entry?
PLoS Med. 2016 Feb 9.
PMID: 26859662.
Luo J, Kesselheim AS.
Insulin patents and market exclusivities: unresolved issues--Authors' reply.
Lancet Diabetes Endocrinol. 2016 Feb.
PMID: 26825232.
The 505(b)(2) Drug Approval Pathway.
Food Drug Law J. 2019 Dec.
Hong P, Sarpatwari A, Kesselheim AS.
Orphan Drug Designation and Exclusivity for “Same Drugs”.
J Law Med Ethics. 2019 Jun.
PMID: 31298092
Jung EH, Sarpatwari A, Kesselheim AS, Sinha MS.
FDA and EMA Biosimilar Approvals.
J Gen Intern Med. [Epub 2019 May; Repub 2019 Dec 2].
PMID: 31637641
Beall RF, Hwang TJ, Kesselheim AS.
Major Events in the Life Course of New Drugs, 2000-2016.
N Engl J Med. 2019 Mar 14.
PMID: 30865793
Beall RF, Darrow JJ, Kesselheim AS.
Approximating Future Generic Entry for New Drugs.
J Law Med Ethics. 2019 Mar.
PMID: 30994060
Beall RF, Kesselheim AS, Sarpatwari A.
New Drug Formulations and Their Respective Generic Entry Dates.
J Manag Care Spec Pharm. 2019 Feb.
PMID: 30698097
Minssen T, Kesselheim AS, Darrow JJ.
An export-only exception to pharmaceutical patents in Europe: should the United States follow suit?
Nat Biotechnol. 2019 Jan 3.
PMID: 30605154
Gagne JJ, Sarpatwari A, Desai RJ.
Role of Authorized Generics in Postapproval Surveillance of Generic Drug Products.
Clin Pharmacol Ther. 2019 Feb. [Epub Dec 2018].
PMID: 30593655.
Darrow JJ, Beall RF, Kesselheim AS.
The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents.
Appl Health Econ Health Policy. 2019 Feb. [Epub 2018 Aug 24].
PMID: 30141133.
Sarpatwari A, Barenie R, Curfman G, Darrow JJ, Kesselheim AS.
The US Biosimilar Market: Stunted Growth and Possible Reforms.
Clin Pharmacol Ther. 2019 Jan. [Epub 2018 Dec 28].
PMID: 30415479.
Beall RF, Darrow JJ, Kesselheim AS.
Patent term restoration for top-selling drugs in the United States.
Drug Discov Today. 2019 Jan. [Epub 2018 Jul 25].
PMID: 30055271.
Beall RF, Darrow JJ, Kesselheim AS.
A Method for Approximating Future Entry of Generic Drugs.
Value Health. 2018 Dec. [Epub 2018 Jun 11].
PMID: 30502781.
Wang A, Kesselheim AS.
Government Patent Use to Address the Rising Cost of Naloxone: 28 U.S.C. § 1498 and Evzio.
J Law Med Ethics. 2018 Jun.
PMID: 30146993.
Beall RF, Kesselheim AS.
Tertiary patenting on drug-device combination products in the United States.
Nat Biotechnol. 2018 Feb 6;36(2):142-145.
PMID: 29406508.
Kapczynski A, Kesselheim AS
Why 'Government Patent Use' to Lower Drug Costs Won't Stifle Innovation.
Health Affairs Blog. 2016 Jul 28.
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 1.
PMID: 27437823.
Treasure CL, Kesselheim AS.
How Patent Troll Legislation Can Increase Timely Access to Generic Drugs.
JAMA Intern Med. 2016 Jun 1.
PMID: 27183456.
Kapczynski A, Kesselheim AS.
'Government Patent Use': A Legal Approach To Reducing Drug Spending.
Health Aff (Millwood). 2016 May 1.
PMID: 27140984.
Capati VC, Kesselheim AS.
Drug Product Life-Cycle Management as Anticompetitive Behavior: The Case of Memantine.
J Manag Care Spec Pharm. 2016 Apr.
PMID: 27023687.
Sarpatwari A, Kesselheim AS.
The Case for Reforming Drug Naming: Should Brand Name Trademark Protections Expire upon Generic Entry?
PLoS Med. 2016 Feb 9.
PMID: 26859662.
Luo J, Kesselheim AS.
Insulin patents and market exclusivities: unresolved issues--Authors' reply.
Lancet Diabetes Endocrinol. 2016 Feb.
PMID: 26825232.
Medical Devices
Hwang TJ, Kesselheim AS, Vokinger KN.
Lifecycle Regulation of Artificial Intelligence- and Machine Learning-Based Software Devices in Medicine.
JAMA. [Epub 2019 Nov 22].
PMID: 31755907
Kesselheim AS, Sinha MS, Campbell EG, Schneeweiss S, Rausch P, Lappin BM, Zhou EH, Avorn J, Dal Pan GJ.
Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem.
Drug Saf. 2019 Nov. [Epub 2019 Jul].
PMID: 31302895
Egilman AC, Kesselheim AS, Krumholz HM, Ross JS, Kim J, Kapczynski A.
Confidentiality Orders and Public Interest in Drug and Medical Device Litigation.
JAMA Intern Med. [Epub 2019 Oct 28].
PMID: 31657836
Kramer DB, Kesselheim AS.
Trust and transparency in medical device regulation.
BMJ. 2019 Jun 18.
PMID: 31213458
Rajan P V, Holtzman JN, Kesselheim AS, Yeh RW, Kramer DB.
Landscape of Cardiovascular Device Registries in the United States.
J Am Heart Assoc. 2019 Jun 4. [Epub 2019 Jun 1].
PMID: 31433706
Lee TT, Kesselheim AS.
U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks.
Ann Intern Med. 2018 May 15. [Epub 2018 Apr 10].
PMID: 29632953.
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 1.
PMID: 28492917.
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. [Epub 2017 Jan 1].
PMID: 28093943.
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.
PMID: 27352914.
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.
PMID: 27437879.
Wang B, Kesselheim AS.
Promoting Therapeutic Innovation: What Do We Do About Drug-Device Combinations?
JAMA. 2016 Mar 1.
PMID: 26934246.
Luo J, Kesselheim AS.
Evolution of insulin patents and market exclusivities in the USA.
Lancet Diabetes Endocrinol. 2015 Nov. [Epub 2015 Oct 6].
PMID: 26453281.
Rajan PV, Kramer DB, Kesselheim AS.
Medical device postapproval safety monitoring: where does the United States stand?
Circ Cardiovasc Qual Outcomes. 2015 Jan. [Epub 2015 Jan 6].
PMID: 25563662.
Lifecycle Regulation of Artificial Intelligence- and Machine Learning-Based Software Devices in Medicine.
JAMA. [Epub 2019 Nov 22].
PMID: 31755907
Kesselheim AS, Sinha MS, Campbell EG, Schneeweiss S, Rausch P, Lappin BM, Zhou EH, Avorn J, Dal Pan GJ.
Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem.
Drug Saf. 2019 Nov. [Epub 2019 Jul].
PMID: 31302895
Egilman AC, Kesselheim AS, Krumholz HM, Ross JS, Kim J, Kapczynski A.
Confidentiality Orders and Public Interest in Drug and Medical Device Litigation.
JAMA Intern Med. [Epub 2019 Oct 28].
PMID: 31657836
Kramer DB, Kesselheim AS.
Trust and transparency in medical device regulation.
BMJ. 2019 Jun 18.
PMID: 31213458
Rajan P V, Holtzman JN, Kesselheim AS, Yeh RW, Kramer DB.
Landscape of Cardiovascular Device Registries in the United States.
J Am Heart Assoc. 2019 Jun 4. [Epub 2019 Jun 1].
PMID: 31433706
Lee TT, Kesselheim AS.
U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks.
Ann Intern Med. 2018 May 15. [Epub 2018 Apr 10].
PMID: 29632953.
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 1.
PMID: 28492917.
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. [Epub 2017 Jan 1].
PMID: 28093943.
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.
PMID: 27352914.
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.
PMID: 27437879.
Wang B, Kesselheim AS.
Promoting Therapeutic Innovation: What Do We Do About Drug-Device Combinations?
JAMA. 2016 Mar 1.
PMID: 26934246.
Luo J, Kesselheim AS.
Evolution of insulin patents and market exclusivities in the USA.
Lancet Diabetes Endocrinol. 2015 Nov. [Epub 2015 Oct 6].
PMID: 26453281.
Rajan PV, Kramer DB, Kesselheim AS.
Medical device postapproval safety monitoring: where does the United States stand?
Circ Cardiovasc Qual Outcomes. 2015 Jan. [Epub 2015 Jan 6].
PMID: 25563662.
Regulatory Science
Hey SP, Kesselheim AS, Patel P, Mehrotra P, Powers JH 3rd.
US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-infective Drug Approvals.
JAMA Intern Med. [Epub 2019 Nov 11].
PMID: 31710344
Rome BN, Kesselheim AS.
Transferrable Market Exclusivity Extensions to Promote Antibiotic Development: An Economic Analysis.
Clin Infect Dis. [Epub 2019 Oct 20].
PMID: 31630159
Vokinger KN, Kesselheim AS.
Application of orphan drug designation to cancer treatments (2008-2017): a comprehensive and comparative analysis of the USA and EU.
BMJ Open. 2019 Oct 10.
PMID: 31601584
Hey SP, D’Andrea E, Jung EH, Tessema F, Luo J, Gyawali B, Kesselheim AS.
Challenges and Opportunities for Biomarker Validation.
J Law Med Ethics. 2019 Sep.
PMID: 31560620
Kesselheim AS, Sinha MS, Rausch P, Lu Z, Tessema FA, Lappin BM, Zhou EH, Dal Pan GH, Zwanziger L, Ramanadham A, Loughlin A, Enger C, Avorn J, Campbell EG.
Patients’ Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey.
J Law Med Ethics. 2019 Sep.
PMID: 31560634
Hey SP, Feldman WB, Jung EH, D’Andrea E, Kesselheim AS.
Surrogate Endpoints and Drug Regulation: What Is Needed to Clarify the Evidence.
J Law Med Ethics. 2019 Sep.
PMID: 31560631
Liu S, Kesselheim AS.
Experiences With and Challenges Afforded by Expedited Regulatory Pathways.
Clin Pharmacol Ther. 2019 Apr.
PMID: 30883712
Seeley E, Kesselheim AS.
Pharmacy Benefit Managers: Practices, Controversies, and What Lies Ahead.
Issue Brief (Commonw Fund). 2019 Mar 1.
PMID: 30990594
Sarpatwari A, Curfman G.
Mitigating Health Risks of Prescription Drugs: Lessons From FDA Oversight of Opioid Products.
JAMA. 2019 Feb 19.
PMID: 30778584
Hwang TJ, Orenstein L, Kesselheim AS, Bourgeois FT.
Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act.
JAMA Pediatr. 2019 Jan 1. [Epub 2018 Nov 19].
PMID: 30452498.
Rogers JR, Sarpatwari A, Desai RJ, Bohn JM, Khan NF, Kesselheim AS, Fischer MA, Gagne JJ, Connolly JG.
Effect of Lawyer-Submitted Reports on Signals of Disproportional Reporting in the Food and Drug Administration's Adverse Event Reporting System.
Drug Saf. 2019 Jan. [Epub 2018 Aug 1].
PMID: 30066315.
Feldman WB, Hey SP, Kesselheim AS.
A Systematic Review Of The Food And Drug Administration's 'Exception From Informed Consent' Pathway.
Health Aff (Millwood). 2018 Oct.
PMID: 30273035.
Sacks CA, Kesselheim AS, Fralick M.
The Shortage of Normal Saline in the Wake of Hurricane Maria.
JAMA Intern Med. 2018 Jul 1.
PMID: 29799949.
Darrow JJ, Avorn J, Kesselheim AS.
The FDA Breakthrough-Drug Designation - Four Years of Experience.
N Engl J Med. 2018 Apr 12.
PMID: 29641970.
Fralick M, Kesselheim AS, Avorn J, Schneeweiss S.
Use of Health Care Databases to Support Supplemental Indications of Approved Medications.
JAMA Intern Med. 2018 Jan 1.
PMID: 29159410.
Sinha MS, Kesselheim AS, Darrow JJ.
Pharmaceutical Advertising in Medical Journals: Revisiting a Long-Standing Relationship.
Chest. 2018 Jan.
PMID: 29307432.
Hey SP.
Ethical Challenges in Biomarker-Driven Drug Development.
Clin Pharmacol Ther. 2018 Jan. [Epub 2017 Sep 25].
PMID: 28944956.
Jung E, Zettler PJ, Kesselheim AS.
Prevalence of Publicly Available Expanded Access Policies.
Clin Pharmacol Ther. 2018 Nov. [Epub 2017 Dec 22].
PMID: 2927104
Darrow JJ, Fuse Brown EC, Kesselheim AS.
The Regulatory Accountability Act of 2017--Implications for FDA Regulation and Public Health.
N Engl J Med. 2018 Feb 1. [Epub 2017 Dec 20].
PMID: 29261363.
Sommers BD, Kesselheim AS.
Massachusetts' Proposed Medicaid Reforms--Cheaper Drugs and Better Coverage.
N Engl J Med. 2018 Jan 11. [Epub 2017 Dec 13].
PMID: 29236573.
Darrow JJ, Avorn J, Kesselheim AS.
Speed, Safety, and the Industry Funding--From PDUFA I to PDUFA VI.
N Engl J Med. 2017 Dec 7.
PMID: 29211663.
Sarpatwari A, Choudhry N.
Recalibrating Privacy Protections to Promote Patient Engagement.
N Engl J Med. 2017 Oct 19.
PMID: 29045208.
Mostaghim SR, Gagne JJ, Kesselheim AS.
Safety Related Label Changes for New Drugs After Approval in the US Through Expedited Regulatory Pathways: Retrospective Cohort Study.
BMJ. 2017 Sep 7.
PMID: 28882831.
Hey SP, Cohen IG, Adashi EY, Kesselheim AS.
Influence, Integrity, and the FDA: An Ethical Framework.
Science. 2017 Sep 1.
PMID: 28860375.
Jain N, Hwang T, Franklin JM, Kesselheim AS.
Association of the Priority Review Voucher With Neglected Tropical Disease Drug and Vaccine Development.
JAMA. 2017 Jul 25.
PMID: 28742898.
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. [Epub 2017 Apr 27].
PMID: 28449404.
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. [Epub 2017 Mar 31].
PMID: 28370652.
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 Safety. 2017 Jun. [Epub 2017 Feb 28].
PMID: 28247279
Fralick M, Kesselheim AS.
FDA Approval of Desmopressin for Nocturia.
JAMA. 2017 May 23. [Epub 2017 Apr 6].
PMID: 28384655.
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. [Epub 2017 Mar 24].
PMID: 28339323.
Kesselheim AS, Avorn J.
FDA Approval of Eteplirsen for Muscular Dystrophy-Reply.
JAMA. 2017 Apr 11.
PMID: 28399248.
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 Apr 8. [Epub 2017 May 27].
PMID: 28390139.
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 Apr 7.
PMID: 28388667.
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 1. [Epub 2017 Jan 18].
PMID: 28100464.
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 3.
PMID: 28045970.
Sinha MS, Kesselheim AS.
Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals.
Bioorg Med Chem. 2016 Dec 15.
PMID: 27591793.
Robertson C, Kesselheim AS.
Regulating Off-Label Promotion - A Critical Test.
New Engl J Med. 2016 Dec 15. [Epub 2016 Aug 22].
PMID: 27805841.
Kesselheim AS, Avorn J.
Approving a Problematic Muscular Dystrophy Drug: Implications for FDA Policy.
JAMA. 2016 Dec 13.
PMID: 27775756.
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 1.
PMID: 27723879.
Sarpatwari A, Gagne JJ, Levidow NL, Kesselheim AS.
Active Surveillance of Follow-on Biologics: A Prescription for Uptake.
Drug Saf. 2017 Feb. [Epub 2016 Nov 12].
PMID: 27838823.
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 Oct 21.
PMID: 27768700.
Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS.
Generic Drug Approvals Since the 1984 Hatch-Waxman Act.
JAMA Intern Med. 2016 Sep 1.
PMID: 27428055.
Hey SP, Kesselheim AS.
The FDA, Juno Therapeutics, and the ethical imperative of transparency.
BMJ. 2016 Aug 15.
PMID: 27526698.
Sarpatwari A, Gagne JJ.
Balancing benefits and harms: privacy protection policies.
Pharmacoepidemiol Drug Saf. 2016 Aug. [Epub 2016 Jun 9].
PMID: 27278106.
Sarpatwari A, Kesselheim AS.
Efficacy of the Priority Review Voucher Program.
JAMA. 2016 Apr 19.
PMID: 27092839.
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.
PMID: 27115269.
Hey SP, Kesselheim AS.
An Uninformative Truth: The Logic of Amarin's Off-Label Promotion.
PLoS Med. 2016 Mar 15.
PMID: 26978686.
Podolsky SH, Kesselheim AS.
Regulating Homeopathic Products - A Century of Dilute Interest.
New Engl J Med. 2016 Jan 21.
PMID: 26789866.
Kesselheim AS, Maggs LR, Sarpatwari A.
Experience With the Priority Review Voucher Program for Drug Development.
JAMA. 2015 Oct 27.
PMID: 26414802.
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.
PMID: 26105011.
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.
PMID: 26400751.
Ross JS, Kesselheim AS.
FDA Policy and Cardiovascular Medicine.
Circulation. 2015 Sep 22.
PMID: 26391294.
Avorn J, Sarpatwari A, Kesselheim AS.
Forbidden and Permitted Statements about Medications--Loosening the Rules.
New Engl J Med. 2015 Sep 3.
PMID: 26332553.
Sharfstein JM, Kesselheim AS.
The Safety of Prescription Drugs.
JAMA. 2015 Jul 21.
PMID: 26197182.
Sarpatwari A, Avorn J, Kesselheim AS.
Progress and Hurdles for Follow-on Biologics.
New England J Med. 2015 Jun 18. [Epub 2015 May 6].
PMID: 25946143.
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.
PMID: 25968811.
Hwang TJ, Lehmann LS, Kesselheim AS.
Precision medicine and the FDA's draft guidance on laboratory-developed tests.
Nat Biotechnol. 2015 May.
PMID: 25965745.
Sarpatwari A, Darrow JJ, Kesselheim AS.
Expanded access to investigational drugs.
New Engl J Med. 2015 Apr 9.
PMID: 25853762.
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.
PMID: 25822610.
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.
PMID: 25664700.
Kramer DB, Kesselheim AS.
The Watchman saga--closure at last?
New Engl J Med. 2015 Mar 12.
PMID: 25760353.
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.
Clinical Pharmacol Ther. 2015 Feb. [Epub 2014 Dec 20].
PMID: 25670524.
Kesselheim AS, Darrow JJ.
FDA designations for therapeutics and their impact on drug development and regulatory review outcomes.
Clinical Pharmacol Ther. 2015 Jan. [Epub 2014 Dec 1].
PMID: 25670381.
Darrow JJ, Kesselheim AS.
A New Wave of Vaccines for Non-Communicable Diseases: What Are the Regulatory Challenges?
Food Drug Law J. 2015
PMID: 26302599.
US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-infective Drug Approvals.
JAMA Intern Med. [Epub 2019 Nov 11].
PMID: 31710344
Rome BN, Kesselheim AS.
Transferrable Market Exclusivity Extensions to Promote Antibiotic Development: An Economic Analysis.
Clin Infect Dis. [Epub 2019 Oct 20].
PMID: 31630159
Vokinger KN, Kesselheim AS.
Application of orphan drug designation to cancer treatments (2008-2017): a comprehensive and comparative analysis of the USA and EU.
BMJ Open. 2019 Oct 10.
PMID: 31601584
Hey SP, D’Andrea E, Jung EH, Tessema F, Luo J, Gyawali B, Kesselheim AS.
Challenges and Opportunities for Biomarker Validation.
J Law Med Ethics. 2019 Sep.
PMID: 31560620
Kesselheim AS, Sinha MS, Rausch P, Lu Z, Tessema FA, Lappin BM, Zhou EH, Dal Pan GH, Zwanziger L, Ramanadham A, Loughlin A, Enger C, Avorn J, Campbell EG.
Patients’ Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey.
J Law Med Ethics. 2019 Sep.
PMID: 31560634
Hey SP, Feldman WB, Jung EH, D’Andrea E, Kesselheim AS.
Surrogate Endpoints and Drug Regulation: What Is Needed to Clarify the Evidence.
J Law Med Ethics. 2019 Sep.
PMID: 31560631
Liu S, Kesselheim AS.
Experiences With and Challenges Afforded by Expedited Regulatory Pathways.
Clin Pharmacol Ther. 2019 Apr.
PMID: 30883712
Seeley E, Kesselheim AS.
Pharmacy Benefit Managers: Practices, Controversies, and What Lies Ahead.
Issue Brief (Commonw Fund). 2019 Mar 1.
PMID: 30990594
Sarpatwari A, Curfman G.
Mitigating Health Risks of Prescription Drugs: Lessons From FDA Oversight of Opioid Products.
JAMA. 2019 Feb 19.
PMID: 30778584
Hwang TJ, Orenstein L, Kesselheim AS, Bourgeois FT.
Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act.
JAMA Pediatr. 2019 Jan 1. [Epub 2018 Nov 19].
PMID: 30452498.
Rogers JR, Sarpatwari A, Desai RJ, Bohn JM, Khan NF, Kesselheim AS, Fischer MA, Gagne JJ, Connolly JG.
Effect of Lawyer-Submitted Reports on Signals of Disproportional Reporting in the Food and Drug Administration's Adverse Event Reporting System.
Drug Saf. 2019 Jan. [Epub 2018 Aug 1].
PMID: 30066315.
Feldman WB, Hey SP, Kesselheim AS.
A Systematic Review Of The Food And Drug Administration's 'Exception From Informed Consent' Pathway.
Health Aff (Millwood). 2018 Oct.
PMID: 30273035.
Sacks CA, Kesselheim AS, Fralick M.
The Shortage of Normal Saline in the Wake of Hurricane Maria.
JAMA Intern Med. 2018 Jul 1.
PMID: 29799949.
Darrow JJ, Avorn J, Kesselheim AS.
The FDA Breakthrough-Drug Designation - Four Years of Experience.
N Engl J Med. 2018 Apr 12.
PMID: 29641970.
Fralick M, Kesselheim AS, Avorn J, Schneeweiss S.
Use of Health Care Databases to Support Supplemental Indications of Approved Medications.
JAMA Intern Med. 2018 Jan 1.
PMID: 29159410.
Sinha MS, Kesselheim AS, Darrow JJ.
Pharmaceutical Advertising in Medical Journals: Revisiting a Long-Standing Relationship.
Chest. 2018 Jan.
PMID: 29307432.
Hey SP.
Ethical Challenges in Biomarker-Driven Drug Development.
Clin Pharmacol Ther. 2018 Jan. [Epub 2017 Sep 25].
PMID: 28944956.
Jung E, Zettler PJ, Kesselheim AS.
Prevalence of Publicly Available Expanded Access Policies.
Clin Pharmacol Ther. 2018 Nov. [Epub 2017 Dec 22].
PMID: 2927104
Darrow JJ, Fuse Brown EC, Kesselheim AS.
The Regulatory Accountability Act of 2017--Implications for FDA Regulation and Public Health.
N Engl J Med. 2018 Feb 1. [Epub 2017 Dec 20].
PMID: 29261363.
Sommers BD, Kesselheim AS.
Massachusetts' Proposed Medicaid Reforms--Cheaper Drugs and Better Coverage.
N Engl J Med. 2018 Jan 11. [Epub 2017 Dec 13].
PMID: 29236573.
Darrow JJ, Avorn J, Kesselheim AS.
Speed, Safety, and the Industry Funding--From PDUFA I to PDUFA VI.
N Engl J Med. 2017 Dec 7.
PMID: 29211663.
Sarpatwari A, Choudhry N.
Recalibrating Privacy Protections to Promote Patient Engagement.
N Engl J Med. 2017 Oct 19.
PMID: 29045208.
Mostaghim SR, Gagne JJ, Kesselheim AS.
Safety Related Label Changes for New Drugs After Approval in the US Through Expedited Regulatory Pathways: Retrospective Cohort Study.
BMJ. 2017 Sep 7.
PMID: 28882831.
Hey SP, Cohen IG, Adashi EY, Kesselheim AS.
Influence, Integrity, and the FDA: An Ethical Framework.
Science. 2017 Sep 1.
PMID: 28860375.
Jain N, Hwang T, Franklin JM, Kesselheim AS.
Association of the Priority Review Voucher With Neglected Tropical Disease Drug and Vaccine Development.
JAMA. 2017 Jul 25.
PMID: 28742898.
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. [Epub 2017 Apr 27].
PMID: 28449404.
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. [Epub 2017 Mar 31].
PMID: 28370652.
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 Safety. 2017 Jun. [Epub 2017 Feb 28].
PMID: 28247279
Fralick M, Kesselheim AS.
FDA Approval of Desmopressin for Nocturia.
JAMA. 2017 May 23. [Epub 2017 Apr 6].
PMID: 28384655.
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. [Epub 2017 Mar 24].
PMID: 28339323.
Kesselheim AS, Avorn J.
FDA Approval of Eteplirsen for Muscular Dystrophy-Reply.
JAMA. 2017 Apr 11.
PMID: 28399248.
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 Apr 8. [Epub 2017 May 27].
PMID: 28390139.
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 Apr 7.
PMID: 28388667.
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 1. [Epub 2017 Jan 18].
PMID: 28100464.
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 3.
PMID: 28045970.
Sinha MS, Kesselheim AS.
Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals.
Bioorg Med Chem. 2016 Dec 15.
PMID: 27591793.
Robertson C, Kesselheim AS.
Regulating Off-Label Promotion - A Critical Test.
New Engl J Med. 2016 Dec 15. [Epub 2016 Aug 22].
PMID: 27805841.
Kesselheim AS, Avorn J.
Approving a Problematic Muscular Dystrophy Drug: Implications for FDA Policy.
JAMA. 2016 Dec 13.
PMID: 27775756.
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 1.
PMID: 27723879.
Sarpatwari A, Gagne JJ, Levidow NL, Kesselheim AS.
Active Surveillance of Follow-on Biologics: A Prescription for Uptake.
Drug Saf. 2017 Feb. [Epub 2016 Nov 12].
PMID: 27838823.
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 Oct 21.
PMID: 27768700.
Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS.
Generic Drug Approvals Since the 1984 Hatch-Waxman Act.
JAMA Intern Med. 2016 Sep 1.
PMID: 27428055.
Hey SP, Kesselheim AS.
The FDA, Juno Therapeutics, and the ethical imperative of transparency.
BMJ. 2016 Aug 15.
PMID: 27526698.
Sarpatwari A, Gagne JJ.
Balancing benefits and harms: privacy protection policies.
Pharmacoepidemiol Drug Saf. 2016 Aug. [Epub 2016 Jun 9].
PMID: 27278106.
Sarpatwari A, Kesselheim AS.
Efficacy of the Priority Review Voucher Program.
JAMA. 2016 Apr 19.
PMID: 27092839.
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.
PMID: 27115269.
Hey SP, Kesselheim AS.
An Uninformative Truth: The Logic of Amarin's Off-Label Promotion.
PLoS Med. 2016 Mar 15.
PMID: 26978686.
Podolsky SH, Kesselheim AS.
Regulating Homeopathic Products - A Century of Dilute Interest.
New Engl J Med. 2016 Jan 21.
PMID: 26789866.
Kesselheim AS, Maggs LR, Sarpatwari A.
Experience With the Priority Review Voucher Program for Drug Development.
JAMA. 2015 Oct 27.
PMID: 26414802.
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.
PMID: 26105011.
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.
PMID: 26400751.
Ross JS, Kesselheim AS.
FDA Policy and Cardiovascular Medicine.
Circulation. 2015 Sep 22.
PMID: 26391294.
Avorn J, Sarpatwari A, Kesselheim AS.
Forbidden and Permitted Statements about Medications--Loosening the Rules.
New Engl J Med. 2015 Sep 3.
PMID: 26332553.
Sharfstein JM, Kesselheim AS.
The Safety of Prescription Drugs.
JAMA. 2015 Jul 21.
PMID: 26197182.
Sarpatwari A, Avorn J, Kesselheim AS.
Progress and Hurdles for Follow-on Biologics.
New England J Med. 2015 Jun 18. [Epub 2015 May 6].
PMID: 25946143.
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.
PMID: 25968811.
Hwang TJ, Lehmann LS, Kesselheim AS.
Precision medicine and the FDA's draft guidance on laboratory-developed tests.
Nat Biotechnol. 2015 May.
PMID: 25965745.
Sarpatwari A, Darrow JJ, Kesselheim AS.
Expanded access to investigational drugs.
New Engl J Med. 2015 Apr 9.
PMID: 25853762.
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.
PMID: 25822610.
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.
PMID: 25664700.
Kramer DB, Kesselheim AS.
The Watchman saga--closure at last?
New Engl J Med. 2015 Mar 12.
PMID: 25760353.
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.
Clinical Pharmacol Ther. 2015 Feb. [Epub 2014 Dec 20].
PMID: 25670524.
Kesselheim AS, Darrow JJ.
FDA designations for therapeutics and their impact on drug development and regulatory review outcomes.
Clinical Pharmacol Ther. 2015 Jan. [Epub 2014 Dec 1].
PMID: 25670381.
Darrow JJ, Kesselheim AS.
A New Wave of Vaccines for Non-Communicable Diseases: What Are the Regulatory Challenges?
Food Drug Law J. 2015
PMID: 26302599.
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