Browsing by Author "Kesselheim, Aaron"
Now showing items 1-20 of 24
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Association of Medical Students' Reports of Interactions with the Pharmaceutical and Medical Device Industries and Medical School Policies and Characteristics: A Cross-Sectional Study
Yeh, James S.; Austad, Kirsten E.; Franklin, Jessica M.; Chimonas, Susan; Campbell, Eric G.; Avorn, Jerry; Kesselheim, Aaron S. (Public Library of Science, 2014)Background: Professional societies use metrics to evaluate medical schools' policies regarding interactions of students and faculty with the pharmaceutical and medical device industries. We compared these metrics and ... -
Availability and utilization of cardiovascular fixed-dose combination drugs in the United States
Wang, Bo; Choudhry, Niteesh Kumar; Gagne, Joshua J; Landon, Joan; Kesselheim, Aaron Seth (Elsevier BV, 2015)BACKGROUND: Solid clinical evidence supports the effectiveness and safety of multiple drugs in treating diabetes, dyslipidemia, and hypertension, and numerous fixed-dose combination products (FDCs) containing such drugs ... -
Biomarker-Defined Subsets of Common Diseases: Policy and Economic Implications of Orphan Drug Act Coverage
Kesselheim, Aaron S.; Treasure, Carolyn L.; Joffe, Steven (Public Library of Science, 2017)Aaron Kesselheim and colleagues examine orphan-designated drugs approved between 2009 and 2015 in the United States. -
Burden of Changes in Pill Appearance for Patients Receiving Generic Cardiovascular Medications After Myocardial Infarction
Kesselheim, Aaron Seth; Bykov, Katsiaryna; Avorn, Jerry Lewis; Tong, Angela; Doherty, Michael Joseph; Choudhry, Niteesh Kumar (American College of Physicians, 2014)Background: Generic prescription drugs made by different manufacturers may vary in color or shape, and switching among these drug products may interrupt medication use. Objective: To determine whether nonpersistent use of ... -
The Case for Reforming Drug Naming: Should Brand Name Trademark Protections Expire upon Generic Entry?
Sarpatwari, Ameet; Kesselheim, Aaron S. (Public Library of Science, 2016)Ameet Sarpatwari and Aaron Kesselheim explore whether stripping branded drugs of trademark protection would improve the efficiency and fairness of health care. -
Clinicians’ Contributions to the Development of Coronary Artery Stents: A Qualitative Study of Transformative Device Innovation
Kesselheim, Aaron S.; Xu, Shuai; Avorn, Jerry (Public Library of Science, 2014)Background: Medical device innovation remains poorly understood, and policymakers disagree over how to incentivize early development. We sought to elucidate the components of transformative health care innovation by ... -
Comparative Effectiveness of Generic and Brand-Name Statins on Patient Outcomes
Gagne, Joshua J; Choudhry, Niteesh Kumar; Kesselheim, Aaron Seth; Polinski, Jennifer Milan; Hutchins, David; Matlin, Olga S.; Brennan, Troyen Anthony; Avorn, Jerry Lewis; Shrank, William (American College of Physicians, 2014)Background: Statins are effective in preventing cardiovascular events, but patients do not fully adhere to them. Objective: To determine whether patients are more adherent to generic statins versus brand-name statins ... -
Comparative effectiveness of generic versus brand-name antiepileptic medications
Gagne, Joshua J; Kesselheim, Aaron Seth; Choudhry, Niteesh Kumar; Polinski, Jennifer Milan; Hutchins, David; Matlin, Olga S.; Brennan, Troyen Anthony; Avorn, Jerry Lewis; Shrank, William (Elsevier BV, 2015)OBJECTIVE: The objective of this study was to compare treatment persistence and rates of seizure-related events in patients who initiate antiepileptic drug (AED) therapy with a generic versus a brand-name product. METHODS: ... -
Comparison of Rates of Safety Issues and Reporting of Trial Outcomes for Medical Devices Approved in the European Union and United States: Cohort Study
Hwang, Thomas; Sokolov, Elisaveta; Franklin, Jessica M; Kesselheim, Aaron (BMJ, 2016-06-28)OBJECTIVE To evaluate safety alerts and recalls, publication of key trial outcomes, and subsequent US approval of high profile medical devices introduced in the European Union. DESIGN Cohort study. SETTING Novel cardiovascular, ... -
Conflict of Interest Reporting by Authors Involved in Promotion of Off-Label Drug Use: An Analysis of Journal Disclosures
Kesselheim, Aaron Seth; Wang, Bo; Studdert, David Michael; Avorn, Jerry Lewis (Public Library of Science, 2012)Background: Litigation documents reveal that pharmaceutical companies have paid physicians to promote off-label uses of their products through a number of different avenues. It is unknown whether physicians and scientists ... -
A cross-national comparison of 17 countries' insulin glargine drug labels
Polinski, Jennifer Milan; Kesselheim, Aaron Seth; Seeger, John; Connolly, John G.; Choudhry, Niteesh K.; Shrank, William H. (Wiley-Blackwell, 2014)Purpose: Type 2 diabetes mellitus has reached epidemic proportions worldwide. Many patients with type 2 diabetes mellitus will require insulin, and the evidence-based use of insulin is described in the prescription drug ... -
Did FDA Decisionmaking Affect Anti-Psychotic Drug Prescribing in Children?: A Time-Trend Analysis
Wang, Bo; Franklin, Jessica Myers; Eddings, Wesley; Landon, Joan; Kesselheim, Aaron Seth (Public Library of Science (PLoS), 2016)Background: Following Food and Drug Administration (FDA) approval, many drugs are prescribed for non-FDA-approved (“off-label”) uses. If substantial evidence supports the efficacy and safety of off-label indications, ... -
How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review
Kramer, Daniel Bruce; Xu, Shuai; Kesselheim, Aaron Seth (Public Library of Science, 2012)Background: Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify ... -
Innovative research methods for studying treatments for rare diseases: methodological review
Gagne, Joshua J; Thompson, Lauren; O’Keefe, Kelly; Kesselheim, Aaron S (BMJ Publishing Group Ltd., 2014)Objective: To examine methods for generating evidence on health outcomes in patients with rare diseases. Design: Methodological review of existing literature. Setting: PubMed, Embase, and Academic Search Premier searched ... -
Paying Physicians to Prescribe Generic Drugs and Follow-On Biologics in the United States
Sarpatwari, Ameet; Choudhry, Niteesh K.; Avorn, Jerry; Kesselheim, Aaron S. (Public Library of Science, 2015)Aaron Kesselheim and colleagues examine potential strategies to promote greater prescribing of generic drugs and follow-on biologics -
Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval
Kesselheim, Aaron Seth; Eddings, Wesley; Raj, Tara; Campbell, Eric G.; Franklin, Jessica Myers; Ross, Kathryn M.; Fulchino, Lisa A.; Avorn, Jerry Lewis; Gagne, Joshua J (Public Library of Science (PLoS), 2016)Background: Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely ... -
Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China
Kramer, Daniel B.; Tan, Yongtian T.; Sato, Chiaki; Kesselheim, Aaron S. (Public Library of Science, 2013)Daniel Kramer and colleagues compare strategies for postmarket surveillance of medical devices and discuss ways to improve these systems. Please see later in the article for the Editors' Summary -
Postmarketing Trials and Pediatric Device Approvals
Hwang, Thomas J; Kesselheim, Aaron Seth; Bourgeois, Florence Tanya (American Academy of Pediatrics (AAP), 2014)BACKGROUND: Medical devices can be useful in a variety of diseases, but few devices have been specifically approved for use in children. The 2007 Pediatric Medical Device Safety and Improvement Act was passed to stimulate ... -
The Prevalence and Cost of Unapproved Uses of Top-Selling Orphan Drugs
Kesselheim, Aaron Seth; Myers, Jessica Amelia; Solomon, Daniel Hal; Winkelmayer, Wolfgang C.; Levin, Raisa; Avorn, Jerry (Public Library of Science, 2012)Introduction: The Orphan Drug Act encourages drug development for rare conditions. However, some orphan drugs become top sellers for unclear reasons. We sought to evaluate the extent and cost of approved and unapproved ... -
Regulatory Solutions to the Problem of High Generic Drug Costs
Luo, Jing; Sarpatwari, Ameet; Kesselheim, Aaron S. (Oxford University Press, 2015)Recent reports have highlighted dramatic price increases for several older generic drugs, including a number of essential products used to treat deadly infectious diseases. Although most of these medicines have been widely ...