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Aaron S. Kesselheim [6]Aaron Kesselheim [4]
  1. Shuai Xu & Aaron S. Kesselheim (2014). Medical Innovation Then and Now: Perspectives of Innovators Responsible for Transformative Drugs. Journal of Law, Medicine and Ethics 42 (4):564-575.
    Effective medical innovation is a common goal of policymakers, physicians, researchers, and patients both in the private and public sectors. With the recent slowdown in approval of new transformative prescription drugs, many have looked back to the “golden years” of the 1980s and 1990s when numerous breakthrough products emerged. We conducted a qualitative study of innovators directly involved in creation of groundbreaking drugs during that era to determine what made their work successful and how the process of conducting medical innovation (...)
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  2. Kevin Outterson, John H. Powers, Enrique Seoane‐Vazquez, Rosa Rodriguez‐Monguio & Aaron S. Kesselheim (2013). Approval and Withdrawal of New Antibiotics and Other Antiinfectives in the U.S., 1980–2009. Journal of Law, Medicine and Ethics 41 (3):688-696.
    Numerous reports have noted decreasing numbers of antibiotic approvals. To determine the context for this decline, we examined all new molecule entities (NMEs) and new biologic licenses (NBLs) approved by the FDA from 1980–2009, and compared approval rates of the 61 approved antibiotics to trends in other drug classes. We also tracked withdrawals of approved drugs and found more withdrawals for antibiotics than other drug classes. After adjusting for drugs subsequently withdrawn, the record for antibiotic innovation is less dire than (...)
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  3. Aakash Kaushik Shah, Jonathan Warsh & Aaron S. Kesselheim (2013). The Ethics of Intellectual Property Rights in an Era of Globalization. Journal of Law, Medicine and Ethics 41 (4):841-851.
    Since the 1980s, developed countries, led by the United States and the countries of the European Union, have sought to incorporate intellectual property rights provisions into global trade agreements. These countries successfully negotiated the World Trade Organization's 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which required developing countries to adopt intellectual property provisions comparable to developed countries. In this manuscript, we review the policy controversy surrounding TRIPS and examine the two main ethical arguments articulated in its support (...)
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  4. Lindsay Cole, Jennifer Kesselheim & Aaron Kesselheim (2012). Ethical Issues in New Drug Prescribing. Journal of Bioethical Inquiry 9 (1):77-83.
    We use the format of a hypothetical case study to review issues related to pharmaceutical product approval and physician prescribing practices. In this case, a new FDA-approved drug is recommended for a patient who subsequently experiences an adverse event that may or may not be related to the prescription. This case raises a number of ethical and legal considerations physicians routinely face when deciding whether to recommend such drugs for their patients. Despite the need for ongoing observation by the regulatory (...)
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  5. Adam Licurse & Aaron Kesselheim (2011). Conflicts of Interest and the Future of Medicine: The United States, France, and Japan. [REVIEW] Journal of Bioethical Inquiry 8 (4):383-386.
    Conflicts of Interest and the Future of Medicine: The United States, France, and Japan Content Type Journal Article Category Book Review Pages 383-386 DOI 10.1007/s11673-011-9326-y Authors Adam Licurse, Division of Internal Medicine, Department of Medicine, Brigham and Women’s Hospital, Boston, MA, USA Aaron S. Kesselheim, Harvard Medical School, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, 1620 Tremont St. Suite 3030, Boston, MA, USA Journal Journal of Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529 Journal Volume (...)
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  6. Aaron S. Kesselheim, Martin T. November, Karen L. Lifford, Thomas F. McElrath, Ann L. Puopolo, E. John Orav & David M. Studdert (2010). Using Malpractice Claims to Identify Risk Factors for Neurological Impairment Among Infants Following Non‐Reassuring Fetal Heart Rate Patterns During Labour. Journal of Evaluation in Clinical Practice 16 (3):476-483.
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  7. Thaddeus Mason Pope, Joshua J. Gagne & Aaron S. Kesselheim (2010). Reviews in Medical Ethics. Journal of Law, Medicine and Ethics 38 (2):427-435.
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  8. Aaron S. Kesselheim & Jerry Avorn (2009). Using Patent Data to Assess the Value of Pharmaceutical Innovation. Journal of Law, Medicine and Ethics 37 (2):176-183.
    Though many more patents emerge from industry sources, drug-related patents generated in the non-profit setting appear to have greater importance than patents arising from the commercial sector, which helps demonstrate the value non-profit research institutions can have in driving drug development.
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