Viewpoint: Promoting Patient Interests in Implementing the Federal Right to Try Act

JAMA, August 13, 2018
Holly Fernandez Lynch (former Executive Director and Academic Fellow Alumna), Patricia J. Zettler, Ameet Sarpatwari

Former Executive Director and Academic Fellow Alumna Holly Fernandez Lynch has co-authored an opinion piece on the federal Right to Try Act of 2017. From the article:

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Administering Health Innovation

Cardozo Law Review, Volume 39, Issue 6 (July 2018)
Rachel E. Sachs (Academic Fellow Alumna)

From the article: Scholars and policymakers have recently begun to focus on the role federal agencies charged with health-related missions can play in the development of innovative health technologies and promotion of access to those technologies. Appreciating the…

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Delinking Reimbursement

Minnesota Law Review, Vol. 102, Issue 6 (July 2018)
Rachel Sachs (Academic Fellow Alumna)

Introduction: Recently, scholars and policymakers on both sides of the aisle have become interested in the legal and regulatory structures surrounding pharmaceutical approval and reimbursement in this country. Scholars focusing on the Food and Drug Administration…

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Drug Approval in a Learning Health System

Minnesota Law Review, 2018
W. Nicholson Price

From the abstract: The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA — and the health system generally — should gather information after drugs are approved to learn…

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Drug Approval in a Learning Health System

Minnesota Law Review, Forthcoming, July 30, 2018
W. Nicholson Price (Academic Fellow Alumnus)

From the article: The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn…

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Defensive Medicine: Evidence from Military Immunity

National Bureau of Economic Research Working Paper Series , July 2018
Michael D. Frakes (Former Academic Fellow) and Jonathan Gruber

From the abstract:  We estimate the extent of defensive medicine by physicians, embracing the no-liability counterfactual made possible by the structure of liability rules in the Military Heath System. Active-duty patients seeking treatment from military facilities…

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Patent term restoration for top-selling drugs in the USA

Drug Discovery Today, July 25, 2018
Reed F. Beall, Jonathan Darrow (Former Student Fellow), and Aaron S. Kesselheim

From the article:  Patents temporarily protect brand-name drugs from generic competition, but some of the 20-year patent term is used up before marketing approval. To compensate for patent life lost to clinical testing and regulatory review, current law provides…

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Medical Liability and Treatment Relationships

Wolters Kluwer, Fourth edition, 2018
Mark A. Hall, David Orentlicher, Mary Anne Bobinski, Nicholas Bagley, I. Glenn Cohen (Faculty Director)

From the description:  Medical Liability and Treatment Relationships is based on Part I, “The Provider and the Patient,” of parent book Health Care Law and Ethics, and adds additional coverage of professional licensure and regulating access to drugs, and new…

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Bioethics and Public Health Law

Wolters Kluwer, Fourth edition, 2018
Mary Anne Bobinski, David Orentlicher, I. Glenn Cohen (Faculty Director), Mark A. Hall

From the description:  Financial and ethical issues are integrated into this concise and engaging treatment of Bioethics and Public Health Law. The complex relationship between patients, providers, the state, and public health institutions are explored through high-interest cases,…

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Health Care Law and Ethics

Wolters Kluwer, Ninth edition, 2018
Mark A. Hall, David Orentlicher, Mary Anne Bobinski, Nicholas Bagley, I. Glenn Cohen (Faculty Director)

From the description:  Health Care Law and Ethics, Ninth Edition offers a relationship-oriented approach to health law—covering the essentials, as well as topical and controversial subjects. The book provides thoughtful and teachable coverage of every aspect of health care law.…

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When clinical trials compete: prioritising study recruitment

BMJ, January 20, 2017
Luke Gelinas, Holly Fernandez Lynch, Barbara E Bierer, I. Glenn Cohen (Faculty Director)

From the abstract:  It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There…

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Personhood Seeking New Life with Republican Control

Indiana Law Journal, April 2017
Jonathan F. Will, I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

From the abstract:  Just three days prior to the inauguration of Donald J. Trump as president of the United States, Rep. Jody B. Hice (R-GA) introduced the Sanctity of Human Life Act (H.R. 586), which, if enacted, would provide that the rights associated with…

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Moratoria and Innovation in the Reproductive Sciences: Of Pretext, Permanence, Transparency, and Timelimits

Journal of Health & Biomedical Law, 2018
Russell Spivak, I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

From the abstract:  As progress in the biosciences soldiers forth, new breakthroughs can often be swept up in a common narrative, that is, the narrative of science as a disruptive threat. Responding to perceived threats, policymakers the world over have frequently…

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“What Is PER?” Patient Engagement in Research as a Hit

Canadian Journal of Bioethics / Revue canadienne de bioéthique, July 6, 2018, Vol 1, Issue 2
By Jean-Christophe Bélisle-Pipon (Visiting Researcher), Claudio Del Grande, and Geneviève Rouleau

From the paper: Engaging patients in research conduct and agenda setting is increasingly considered as an ethical imperative, and a way to transcend views of patients as passive subjects by fostering their empowerment. However, patient engagement in research (PER)…

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Informed Consent and the Role of the Treating Physician

New England Journal of Medicine, June 21, 2018
By Holly Fernandez Lynch (Former Executive Director), Steven Joffe, and Eric A. Feldman

From the paper: In the century since Justice Benjamin N. Cardozo famously declared that “[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body,”1 informed consent has become a central feature…

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Regulation of Stem Cell Therapy Travel

Current Stem Cell Reports, July 2018
I. Glenn Cohen and Shelly Simana

From the abstract: Purpose of Review Stem cell therapies (hereinafter: SCT) hold tremendous promise for the treatment of a variety of diseases. Yet, alongside the medical potential, they pose significant risks. This…

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Don’t Expect Brett Kavanaugh To Protect The Affordable Care Act

WBUR Cognoscenti, July 12, 2018
Carmel Shachar

From the article:  Thanks to Brett Kavanaugh’s 12 years as a judge on the D.C. Court of Appeals, we have a well-developed record of the Supreme Court nominee’s positions on key issues, including his views on American health care policy. …

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IRB Oversight of Patient-Centered Outcomes Research: A National Survey of IRB Chairpersons

Journal of Empirical Research on Human Research Ethics, June 14, 2018
Joel S. Weissman, Eric G. Campbell, I. Glenn Cohen, Holly Fernandez Lynch, Emily A. Largent, Avni Gupta, Ronen Rozenblum, Melissa Abraham, Karen Spike

From the abstract:  Patient-centered outcomes research (PCOR) is becoming increasingly common. However, there is little evidence regarding what novel ethical challenges, if any, are posed by PCOR with relevance to institutional review board (IRB) oversight and…

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A Method for Approximating Future Entry of Generic Drugs

Value in Health Journal, June 11, 2018
Jonathan J. Darrow, SJD, JD, MBA, (Student fellow alumnus) Aaron S. Kesselheim, MD, JD, MPH, Reed F. Beall, PhD

From the abstract:  Objectives To develop and test a method for approximating generic entry of top-selling drugs. Methods The…

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Building Capacity for a Global Genome Editing Observatory: Institutional Design

Trends in Biotechnology, June, 2018
Krishanu Saha, J. Benjamin Hurlbut,Sheila Jasanoff,Aziza Ahmed, Anthony Appiah, Elizabeth Bartholet [...] I. Glenn Cohen (Faculty Director)[...]

Complete author list: Krishanu Saha, J. Benjamin Hurlbut, Sheila Jasanoff, Aziza Ahmed, Anthony Appiah, Elizabeth Bartholet,  Françoise Baylis, Gaymon Bennett, George Church, I. Glenn Cohen, George Daley, Kevin Finneran, William Hurlbut, Rudolf Jaenisch, Laurence Lwoff,…

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