Grants

Berkeley Technology Law Journal, May 10, 2018
W. Nicholson Price II (Academic Fellow Alumnus)

From the paper: Innovation is a primary source of economic growth, and is accordingly the target of substantial academic and government attention. Grants are a key tool in the government’s arsenal of tools to promote innovation, but legal academic studies of…

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Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines

Health Affairs , May 2018
Lisette Pregelj, Thomas J. Hwang, Damian C. Hine, Evan B. Siegel, Ross T. Barnard, Jonathan J. Darrow (Student Fellow Alumnus), Aaron S. Kesselheim

From the article: Precision medicines can benefit patients by increasing the probability of a successful treatment response in selected patient populations. The potential for more immediate signals of efficacy during clinical trials suggests such medicines will reach…

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Addressing Financial Barriers to Enrollment in Clinical Trials

JAMA Oncology, April 19, 2018
Emily A. Largent and Holly Fernandez Lynch (Former Executive Director)

From the article: Shortfalls in clinical trial recruitment and retention constitute a major obstacle to scientific advancement. One means of increasing patient participation rates is to reduce associated financial burdens. In several states, efforts are under way…

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Preventing Mitochondrial Diseases: Embryo-Sparing Donor-Independent Options

Trends in Molecular Medicine, Volume 24, Issue 5 (May 2018)
Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

Abstract Mutant mitochondrial DNA gives rise to a broad range of incurable inborn maladies. Prevention may now be possible by replacing the mutation-carrying mitochondria of zygotes or oocytes at risk with donated unaffected counterparts. However, mitochondrial…

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REPORT: Ethical Issues Related to the Creation of Synthetic Human Embryos

Harvard University Embryonic Stem Cell Research Oversight (“ESCRO”) Committee, April 2018

Report Summary Authored by Robert D. Truog, MD (Center for Bioethics, Harvard Medical School) and Melissa J. Lopes, JD…

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Efficacy, Safety, and Regulatory Approval of Food and Drug Administration–Designated Breakthrough an

Journal of Clinical Oncology , April 24, 2018
Thomas J. Hwang, Jessica M. Franklin, Julie C. Lauffenburger, Bishal Gyawali, Aaron S. Kesselheim, and Jonathan J. Darrow (Student Fellow Alumnus)

From the article: The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. We evaluated the times to approval, efficacy, and safety of breakthrough-designated versus non–breakthrough-designated cancer…

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Redesigning Provider Payments to Reduce Long-Term Costs by Promoting Healthy Development

National Academy of Medicine, April 20, 2018
Nathaniel Z. Counts (Student Fellow alumnus), Neal Halfon, Kelly J. Kelleher, J. David Hawkins, Laurel K. Leslie, Thomas F. Boat, Mary Ann McCabe

From the article: Cognitive, aff ective, and behavioral health (CAB) conditions are among the costliest and fastest growing in the United States. An array of interventions is demonstrated to be eff ective in preventing or mitigating these conditions and off ers the…

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The FDA Breakthrough-Drug Designation — Four Years of Experience

The New England Journal of Medicine, April 12, 2018
Jonathan J. Darrow (Student Fellow Alumnus), Jerry Avorn, and Aaron S. Kesselheim,

This article is behind a paywall. Harvard affiliates can access the full text via Hollis +. From the article: In 2012, Congress created the “breakthrough therapy” designation to expedite…

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New Article Examines the Possibility of Applying Workplace Safety Rules to the NFL

Part of the Law and Ethics Initiative of the Football Players Health Study at Harvard University, April 17, 2018
Article authored by Adam M. Finkel, Chris Deubert, Orly Lobel, I. Glenn Cohen (Faculty Director), and Holly Fernandez Lynch (Former Executive Director

Could occupational health and safety laws be applied to better protect NFL players? A new analysis, published on April 17 in the Arizona Law Review, explores this very possibility. …

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Bystander risk, social value, and ethics of human research

Science, April 13, 2018, Volume 360, Issue 6385
S. K. Shah, J. Kimmelman, A. D. Lyerly, H. F. Lynch (Former Executive Director), F. G. Miller, R. Palacios, C. A. Pardo, C. Zorrilla

From the article: Two critical, recurring questions can arise in many areas of research with human subjects but are poorly addressed in much existing research regulation and ethics oversight: How should research risks to “bystanders” be addressed? And…

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On Scarcity and the Value of Clinical Trials

The American Journal of Bioethics, 2018, Issue 4, Volume 18
Luke Gelinas (Senior Researcher), Holly Fernandez Lynch (Former Executive Director), Barbara E. Bierer, & I. Glenn Cohen (Faculty Director)

From the artice: Allocation of scarce goods and resources is a common concern in the health care context, from intensive care unit (ICU) beds, to extracorporeal membrane oxygenation (ECMO) machines, to vaccines, to organs for transplant. Problems raised by scarcity…

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Mutual Obligations in Research and Withholding Payment From Deceptive Participants

The American Journal of Bioethics, 2018, Issue 4, Volume 18
Holly Fernandez Lynch (Former Executive Director), Luke Gelinas (Senior Researcher), & Emily A. Largent

From the article: Paying research participants can be ethically charged, both when payment is offered and—as demonstrated in this case—when it is withheld. When individuals undergoing screening intentionally deceive investigators as to their eligibility,…

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Assisted Reproduction in Israel: Law, Religion, and Culture

Brill Research Perspectives, March 20, 2018
Avishalom Westreich

From the article: The theme of this composition is the right to procreate in the Israeli context. Our discussion of this right includes the implementation of the right to procreate, restrictions on the right (due to societal, legal, or religious concerns), and the…

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NOW AVAILABLE! Big Data, Health Law, and Bioethics

Cambridge University Press, March 2018
I. Glenn Cohen (Faculty Director), Holly Fernandez Lynch (former Executive Director), Urs Gasser, and Effy Vayena

Now available - order it online!  From the book: When data from…

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Prevalence of Publicly Available Expanded Access Policies

Clinical Pharmacology & Therapeutics, March 23, 2018
Emily Jung (Petrie-Flom Student Intern), Patricia J. Zettler, Aaron S. Kesselheim

From the Article: The Food and Drug Administration's expanded access program allows patients with serious or immediately life‐threatening conditions to seek access to experimental drugs and treatments from their manufacturers. The 21st Century Cures Act…

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Price Insensitivity. Guest, Rachel Sachs

The Week in Health Law, Episode 132, March 22, 2018
Nicolas Terry and Frank Pasquale, interviewing Rachel Sachs (Academic Fellow Alumna)

From the podcast: This week’s episode features a welcome return from Rachel Sachs, Associate Professor of Law at the Washington University in St. Louis School of Law. Rachel’s primary research interests lie at the intersection…

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Can Rationing through Inconvenience Be Ethical?

Hasting Center Report, Volume 48, Issue 1
Nir Eyal, Paul L. Romain, and Christopher T. Robertson (Academic Fellow alumnus)

From the Article: In this article, we provide a comprehensive analysis and a normative assessment of rationing through inconvenience as a form of rationing. By “rationing through inconvenience” in the health sphere, we refer to a nonfinancial burden (the…

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The Legal and Ethical Environment of Business, Second Edition

Wolters Kluwer, New York , 2018
Gerald R. Ferrera, Mystica M. Alexander, William P. Wiggins, Cheryl Kirschner, Jonathan Darrow (Student Fellow Alumnus)

Summary of the text: Focusing on ethics in every aspect of the business environment, The Legal and Ethical Environment of Business, Second Edition, prepares students to work within current industry norms, practices, and legislation. Ethics coverage is integrated…

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Promoting Competition To Address Pharmaceutical Prices

Health Affairs, March 15, 2018
Jonathan Darrow (Student Fellow Alumnus), Aaron S. Kesselheim

From the article Under ideal market conditions, competition among producers of a commercial good can drive down prices. The market for pharmaceuticals, however, is inefficient in many ways, leading to rapid price increases in recent years, even for some drugs without…

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Assisted Reproduction in Israel: Law, Religion, and Culture

Brill, March 20, 2018
Avishalom Westreich (Visiting Scholar)

From the article: The theme of this composition is the right to procreate in the Israeli context. Our discussion of this right includes the implementation of the right to procreate, restrictions on the right (due to societal, legal, or religious…

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