Research Topics
| A S KesselheimSummaryAffiliation: Massachusetts General Hospital Country: USA Publications
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Detail Information
Publications
Extensions of intellectual property rights and delayed adoption of generic drugs: effects on medicaid spendingAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Harvard Medical School, in Boston, Massachusetts, USA
Health Aff (Millwood) 25:1637-47. 2006..The delay in availability, elevated prices, and slow uptake of generic alternatives for these three drugs alone cost Medicaid 1.5 billion dollars in 2000-2004...- University-based science and biotechnology products: defining the boundaries of intellectual propertyAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Mass 02120, USA
JAMA 293:850-4. 2005.... - Pharmaceutical promotion to physicians and First Amendment rightsAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, USA
N Engl J Med 358:1727-32. 2008 
Variations in pill appearance of antiepileptic drugs and the risk of nonadherenceAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, MA 02120, USA
JAMA Intern Med 173:202-8. 2013..We sought to determine whether switching among different-appearing antiepileptic drugs (AEDs) is associated with increased rates of medication nonpersistence, which can have serious medical, financial, and social consequences...- The Food and Drug Administration has the legal basis to restrict promotion of flawed comparative effectiveness researchAaron S Kesselheim
Harvard Medical School, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital, Boston, Massachusetts, USA
Health Aff (Millwood) 31:2200-5. 2012..At that point, the FDA will need to issue formal guidance to minimize confusion on what kinds of observational research can meet its evidentiary standards... 
Conflict of interest reporting by authors involved in promotion of off-label drug use: an analysis of journal disclosuresAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, Massachusetts, United States of America
PLoS Med 9:e1001280. 2012..It is unknown whether physicians and scientists who have such conflicts of interest adequately disclose such relationships in the scientific publications they author...- Ethical considerations in orphan drug approval and useA S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, Massachusetts, USA
Clin Pharmacol Ther 92:153-5. 2012..Therefore, the ethical principles of justice and beneficence may require attention to informed consent among patients receiving the drugs and greater investment in postmarket surveillance and confirmational testing... - A randomized study of how physicians interpret research funding disclosuresAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, Massachusetts 02120, USA
N Engl J Med 367:1119-27. 2012..The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians' reactions to trials with a high, medium, or low level of methodologic rigor... - The prevalence and cost of unapproved uses of top-selling orphan drugsAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, Massachusetts, United States of America
PLoS ONE 7:e31894. 2012..However, some orphan drugs become top sellers for unclear reasons. We sought to evaluate the extent and cost of approved and unapproved uses of orphan drugs with the highest unit sales... - Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysisAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Harvard Medical School, Boston, MA 02120, USA
JAMA 300:2514-26. 2008..Use of generic drugs, which are bioequivalent to brand-name drugs, can help contain prescription drug spending. However, there is concern among patients and physicians that brand-name drugs may be clinically superior to generic drugs... - Professional oversight of physician expert witnesses: an analysis of complaints to the Professional Conduct Committee of the American Association of Neurological Surgeons, 1992-2006Aaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Harvard Medical School, Boston, MA 02120, USA
Ann Surg 249:168-72. 2009..The program adjudicates complaints against AANS members for their work as expert witnesses in medical malpractice litigation... - Managing financial and nonfinancial conflicts of interest in healthcare deliveryAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Boston, MA 02115, USA
Am J Ther 17:440-3. 2010..The case history, device, physician, and patient described below do not represent actual people or events, but are intended to be emblematic of the challenges faced in the current medical marketplace... - Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: a systematic review and meta-analysisAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, Massachusetts 02120, USA
Drugs 70:605-21. 2010..In the absence of better data, physicians may want to consider more intensive monitoring of high-risk patients taking AEDs when any switch occurs... - Using malpractice claims to identify risk factors for neurological impairment among infants following non-reassuring fetal heart rate patterns during labourAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Harvard Medical School, Boston, MA02120, USA
J Eval Clin Pract 16:476-83. 2010..We sought to use a novel case-selection methodology to identify antenatal or intrapartum risk factors associated with neonatal neurological impairment following non-reassuring fetal heart rate patterns during labour... - Permitting product liability litigation for FDA-approved drugs and devices promotes patient safetyA S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital and Harvard Medical School, Boston, Massachusetts, USA
Clin Pharmacol Ther 87:645-7. 2010..The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products... - Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancerAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, 1620 Tremont St, Ste 3030, Boston, MA 02120, USA
JAMA 305:2320-6. 2011..Orphan products constitute most new drug approvals in oncology, but safety and efficacy questions have emerged about some of these agents... - Conflict of interest in oncology publications: a survey of disclosure policies and statementsAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, MA 02120, USA
Cancer 118:188-95. 2012..The authors sought to define current disclosure policies and how they relate to disclosure statements provided by authors in major oncology journals... - An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequencesAaron S Kesselheim
Brigham and Women s Hospital, Harvard Medical School, Boston, MA 02120, USA
Milbank Q 89:450-502. 2011..With the development of transformative drugs at a low point, numerous commentators have recommended new legislation that uses supplementary market exclusivity as an incentive to promote innovation in the pharmaceutical market... - Clinical decision support systems could be modified to reduce 'alert fatigue' while still minimizing the risk of litigationAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital, Boston, Massachusetts, USA
Health Aff (Millwood) 30:2310-7. 2011..Even so, to limit liability in this area, we recommend stronger government regulation of clinical decision support systems and development of international practice guidelines highlighting the most important warnings... - False Claims Act prosecution did not deter off-label drug use in the case of neurontinAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital, Boston, Massachusetts, USA
Health Aff (Millwood) 30:2318-27. 2011.... - Whistleblower-initiated enforcement actions against health care fraud and abuse in the United States, 1996 to 2005Aaron S Kesselheim
Brigham and Women s Hospital, Boston, Massachusetts, USA
Ann Intern Med 149:342-9. 2008..6 billion (39%) of total recoveries. This study illuminates the scope and characteristics of qui tam fraud litigation and the whistleblowers who animate this important tool for addressing waste in the health care sector... - Confidentiality laws and secrecy in medical research: improving public access to data on drug safetyAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Boston, Massachusetts, USA
Health Aff (Millwood) 26:483-91. 2007..We suggest regulatory and legislative policy changes regarding how the FDA handles confidential information that can improve understanding of the risks of prescription drugs... - Intellectual property policy in the pharmaceutical sciences: the effect of inappropriate patents and market exclusivity extensions on the health care systemAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Harvard Medical School, Boston, MA, USA
AAPS J 9:E306-11. 2007..In response, several different government and market-based efforts have emerged to promote more equitable patent policy in health care that encourages dissemination of ideas while still supporting the development of innovative products... - Role of professional organizations in regulating physician expert witness testimonyAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02120, USA
JAMA 298:2907-9. 2007 - Characteristics of physicians who frequently act as expert witnesses in neurologic birth injury litigationAaron S Kesselheim
Brigham and Women s Hospital and the Harvard School of Public Health, Boston, Massachusetts 02120, USA
Obstet Gynecol 108:273-9. 2006..We sought to describe characteristics of physicians who frequently act as expert witnesses in neurologic birth injury litigation... - The rise and fall of Natrecor for congestive heart failure: implications for drug policyAaron S Kesselheim
Harvard Medical School and Brigham and Women s Hospital, Boston, Massachusetts, USA
Health Aff (Millwood) 25:1095-102. 2006..Based on the nesiritide experience, we suggest several ways to improve policies for drug approval, postmarketing surveillance, and drug utilization... - Biomedical patents and the public's health: is there a role for eminent domain?Aaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital, Harvard Medical School, Boston, Mass, USA
JAMA 295:434-7. 2006 - The international pharmaceutical market as a source of low-cost prescription drugs for U.S. patientsAaron S Kesselheim
Brigham and Women s Hospital, Harvard Medical School, Boston, Massachusetts, USA
Ann Intern Med 148:614-9. 2008.... - The role of litigation in defining drug risksAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, Mass, USA
JAMA 297:308-11. 2007 - The variability and quality of medication container labelsWilliam H Shrank
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Harvard Medical School, 1620 Tremont St, Ste 3030, Boston, MA 02120, USA
Arch Intern Med 167:1760-5. 2007..Medication errors occur frequently, and poor medication labeling is cited as a potential cause. We assessed the format, content, and variability of prescription drug container labels dispensed in the community... - State generic substitution laws can lower drug outlays under MedicaidWilliam H Shrank
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital and Harvard Medical School, Boston, Massachusetts, USA
Health Aff (Millwood) 29:1383-90. 2010..Although these consent requirements are probably intended to increase patient autonomy, policy makers should consider the sizable opportunity costs... - Scientific and legal viability of follow-on protein drugsDavid M Dudzinski
Department of Medicine, Massachusetts General Hospital, Boston, USA
N Engl J Med 358:843-9. 2008 - Where cost, medical necessity, and morality meet: should US government insurance programs pay for erectile dysfunction drugs?J M Polinski
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, Massachusetts, USA
Clin Pharmacol Ther 89:17-9. 2011..We conclude that the clinical usefulness and costs of such drugs should be the primary drivers of coverage decisions, not moral attitudes toward sexual performance... - Using patent data to assess the value of pharmaceutical innovationAaron S Kesselheim
Department of Health Policy and Management, Harvard School of Public Health, Harvard Medical School, USA
J Law Med Ethics 37:176-83. 2009.... - Medical-process patents--monopolizing the delivery of health careAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, USA
N Engl J Med 355:2036-41. 2006 - Overbilling vs. downcoding--the battle between physicians and insurersAaron S Kesselheim
Brigham and Women's Hospital and Harvard Medical School, Boston, USA
N Engl J Med 352:855-7. 2005 - The swinging pendulum: the Supreme Court reverses course on ERISA and managed careAaron S Kesselheim
Division of Internal Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, USA
Yale J Health Policy Law Ethics 5:451-63. 2005 - Will physician-level measures of clinical performance be used in medical malpractice litigation?Aaron S Kesselheim
Department of Health Policy and Management, Harvard School of Public Health, Brigham and Women s Hospital, Boston, Mass 02115, USA
JAMA 295:1831-4. 2006 - Market-based licensing for HPV vaccines in developing countriesKevin Outterson
Boston University School of Law, USA
Health Aff (Millwood) 27:130-9. 2008.... - Rethinking global access to vaccinesDave A Chokshi
University of Pennsylvania School of Medicine, 3434 Sansom St, Philadelphia, PA 19104, USA
BMJ 336:750-3. 2008