A S Kesselheim

Summary

Affiliation: Massachusetts General Hospital
Country: USA

Publications

  1. ncbi request reprint University-based science and biotechnology products: defining the boundaries of intellectual property
    Aaron 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
  2. ncbi request reprint Extensions of intellectual property rights and delayed adoption of generic drugs: effects on medicaid spending
    Aaron 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
  3. doi request reprint Pharmaceutical promotion to physicians and First Amendment rights
    Aaron 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
  4. doi request reprint Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation
    Aaron S Kesselheim
    Program on Regulation, Therapeutics, And Law PORTAL, 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 9:e88664. 2014
  5. pmc Rising health care costs and life-cycle management in the pharmaceutical market
    Aaron 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 10:e1001461. 2013
  6. pmc Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints
    Aaron S Kesselheim
    Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital, Boston, Massachusetts, United States of America
    PLoS Med 8:e1000431. 2011
  7. pmc Medical students' exposure to and attitudes about the pharmaceutical industry: a systematic review
    Kirsten E Austad
    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 8:e1001037. 2011
  8. doi request reprint Defining "innovativeness" in drug development: a systematic review
    A 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 94:336-48. 2013
  9. ncbi request reprint Speaking the same language? International variations in the safety information accompanying top-selling prescription drugs
    Aaron S Kesselheim
    Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, MA 02120, USA
    BMJ Qual Saf 22:727-34. 2013
  10. doi request reprint The most transformative drugs of the past 25 years: a survey of physicians
    Aaron S Kesselheim
    Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital, 1620 Tremont St, Suite 3030, Boston, Massachusetts 02120, USA
    Nat Rev Drug Discov 12:425-31. 2013

Detail Information

Publications51

  1. ncbi request reprint University-based science and biotechnology products: defining the boundaries of intellectual property
    Aaron 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
    ....
  2. ncbi request reprint Extensions of intellectual property rights and delayed adoption of generic drugs: effects on medicaid spending
    Aaron 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...
  3. doi request reprint Pharmaceutical promotion to physicians and First Amendment rights
    Aaron 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
  4. doi request reprint Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation
    Aaron S Kesselheim
    Program on Regulation, Therapeutics, And Law PORTAL, 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 9:e88664. 2014
    ..We sought to elucidate the components of transformative health care innovation by conducting an in-depth case study of development of a key medical device: coronary artery stents...
  5. pmc Rising health care costs and life-cycle management in the pharmaceutical market
    Aaron 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 10:e1001461. 2013
    ..Aaron Kesselheim discusses Natalie Vernaz and colleagues' paper on the effects on health care costs of "evergreening" strategies pursued by drug manufacturers. Please see later in the article for the Editors' Summary...
  6. pmc Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints
    Aaron S Kesselheim
    Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital, Boston, Massachusetts, United States of America
    PLoS Med 8:e1000431. 2011
    ..However, the scope of off-label marketing remains poorly characterized. We developed a typology for the strategies and practices that constitute off-label marketing...
  7. pmc Medical students' exposure to and attitudes about the pharmaceutical industry: a systematic review
    Kirsten E Austad
    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 8:e1001037. 2011
    ..Physicians' attitudes towards the industry can form early in their careers, but little is known about this key stage of development...
  8. doi request reprint Defining "innovativeness" in drug development: a systematic review
    A 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 94:336-48. 2013
    ..By contrast, of 21 studies that used other measures of innovation, 0 concluded that the trend was favorable, 8 (47%) concluded that the trend was not favorable, and 13 reached no conclusion (P = 0.03). ..
  9. ncbi request reprint Speaking the same language? International variations in the safety information accompanying top-selling prescription drugs
    Aaron S Kesselheim
    Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, MA 02120, USA
    BMJ Qual Saf 22:727-34. 2013
    ..The official prescribing information document distributed with a prescription drug is a key source of safety information, but it may include excessive or insufficient details...
  10. doi request reprint The most transformative drugs of the past 25 years: a survey of physicians
    Aaron S Kesselheim
    Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital, 1620 Tremont St, Suite 3030, Boston, Massachusetts 02120, USA
    Nat Rev Drug Discov 12:425-31. 2013
    ..Participants were also asked how various factors affected their opinion; they most often invoked the effectiveness and superiority of the drugs over existing alternatives when identifying transformative drug innovation...
  11. doi request reprint Variations in pill appearance of antiepileptic drugs and the risk of nonadherence
    Aaron 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...
  12. doi request reprint The Food and Drug Administration has the legal basis to restrict promotion of flawed comparative effectiveness research
    Aaron 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...
  13. pmc Conflict of interest reporting by authors involved in promotion of off-label drug use: an analysis of journal disclosures
    Aaron 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...
  14. doi request reprint Ethical considerations in orphan drug approval and use
    A 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...
  15. pmc A randomized study of how physicians interpret research funding disclosures
    Aaron 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...
  16. pmc The prevalence and cost of unapproved uses of top-selling orphan drugs
    Aaron 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...
  17. doi request reprint Using malpractice claims to identify risk factors for neurological impairment among infants following non-reassuring fetal heart rate patterns during labour
    Aaron 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...
  18. doi request reprint Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety
    A 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...
  19. ncbi request reprint Characteristics of physicians who frequently act as expert witnesses in neurologic birth injury litigation
    Aaron 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...
  20. doi request reprint Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer
    Aaron 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...
  21. doi request reprint Conflict of interest in oncology publications: a survey of disclosure policies and statements
    Aaron 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...
  22. pmc An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequences
    Aaron 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...
  23. doi request reprint Clinical decision support systems could be modified to reduce 'alert fatigue' while still minimizing the risk of litigation
    Aaron 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...
  24. doi request reprint False Claims Act prosecution did not deter off-label drug use in the case of neurontin
    Aaron 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
    ....
  25. pmc Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: a systematic review and meta-analysis
    Aaron 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...
  26. doi request reprint Managing financial and nonfinancial conflicts of interest in healthcare delivery
    Aaron 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...
  27. pmc Intellectual property policy in the pharmaceutical sciences: the effect of inappropriate patents and market exclusivity extensions on the health care system
    Aaron 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...
  28. ncbi request reprint Role of professional organizations in regulating physician expert witness testimony
    Aaron S Kesselheim
    Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Harvard Medical School, Boston, Massachusetts 02120, USA
    JAMA 298:2907-9. 2007
  29. ncbi request reprint The role of litigation in defining drug risks
    Aaron S Kesselheim
    Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Harvard Medical School, Boston, Mass, USA
    JAMA 297:308-11. 2007
  30. ncbi request reprint The rise and fall of Natrecor for congestive heart failure: implications for drug policy
    Aaron 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...
  31. ncbi request reprint The international pharmaceutical market as a source of low-cost prescription drugs for U.S. patients
    Aaron S Kesselheim
    Brigham and Women s Hospital, Harvard Medical School, Boston, Massachusetts, USA
    Ann Intern Med 148:614-9. 2008
    ....
  32. ncbi request reprint 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
  33. ncbi request reprint Whistleblower-initiated enforcement actions against health care fraud and abuse in the United States, 1996 to 2005
    Aaron 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...
  34. pmc Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis
    Aaron 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...
  35. doi request reprint Professional oversight of physician expert witnesses: an analysis of complaints to the Professional Conduct Committee of the American Association of Neurological Surgeons, 1992-2006
    Aaron 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...
  36. ncbi request reprint Confidentiality laws and secrecy in medical research: improving public access to data on drug safety
    Aaron 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...
  37. doi request reprint Clinical and regulatory features of drugs not initially approved by the FDA
    B Wang
    Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, Massachusetts, USA
    Clin Pharmacol Ther 94:670-7. 2013
    ..By 2013, 63% had been approved. Products with initial safety concerns (62%) were much more likely to be approved eventually than drugs with efficacy concerns (8%). ..
  38. doi request reprint Strategies for postmarketing surveillance of drugs for rare diseases
    A 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 95:265-8. 2014
    ..Bayesian trials and distributed networks of large electronic databases are the most promising strategies for active and prospective monitoring of clinical interventions for rare diseases. ..
  39. ncbi request reprint The variability and quality of medication container labels
    William 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...
  40. pmc State generic substitution laws can lower drug outlays under Medicaid
    William 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...
  41. doi request reprint Scientific and legal viability of follow-on protein drugs
    David M Dudzinski
    Department of Medicine, Massachusetts General Hospital, Boston, USA
    N Engl J Med 358:843-9. 2008
  42. doi request reprint The evolving role of biomarker patents in personalized medicine
    A S Kesselheim
    Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, Massachusetts, USA
    Clin Pharmacol Ther 95:127-9. 2014
    ....
  43. doi request reprint 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...
  44. ncbi request reprint Medical-process patents--monopolizing the delivery of health care
    Aaron S Kesselheim
    Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Boston, USA
    N Engl J Med 355:2036-41. 2006
  45. ncbi request reprint Overbilling vs. downcoding--the battle between physicians and insurers
    Aaron S Kesselheim
    Brigham and Women s Hospital and Harvard Medical School, Boston, USA
    N Engl J Med 352:855-7. 2005
  46. ncbi request reprint The swinging pendulum: the Supreme Court reverses course on ERISA and managed care
    Aaron 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
  47. doi request reprint Using patent data to assess the value of pharmaceutical innovation
    Aaron 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
    ....
  48. ncbi request reprint 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
  49. pmc Rethinking global access to vaccines
    Dave A Chokshi
    University of Pennsylvania School of Medicine, 3434 Sansom St, Philadelphia, PA 19104, USA
    BMJ 336:750-3. 2008
  50. doi request reprint Market-based licensing for HPV vaccines in developing countries
    Kevin Outterson
    Boston University School of Law, USA
    Health Aff (Millwood) 27:130-9. 2008
    ....