Prize fund for new antibiotics could mean true innovation

STAT News, April 25, 2017
Rachel E. Sachs (Academic Fellow Alumna)

A few weeks ago, a group of Democrats in both houses of Congress introduced the Improving Access to Affordable Prescription Drugs Act, a 129-page bill designed to lower drug prices while increasing innovation and cracking down on pharmaceutical company abuses (my thoughts on the bill are here). …

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Nonexceptionalism, Research Risks, and Social Media: Response to Open Peer Commentaries on “Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations”

American Journal of Bioethics, 17(5):W1-W3, 2017 (Published online April 21, 2017)
Luke Gelinas (Research Ethics Fellow), Robin Pierce, Sabune Winkler, Glenn Cohen (Faculty Dir), Holly Fernandez Lynch (Executive Dir) & Barbara Bierer

We are grateful for the thoughtful commentaries on our target article “Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations” (Gelinas et al. 2017), commentaries that in many cases further clarify and expand upon our recommendations. For the most…

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Science Needs Your Cells: New York Times Op-Ed by Executive Director Holly Fernandez Lynch

New York Times, April 21, 2017
Holly Fernandez Lynch (Executive Director) and Steven Joffe

Biospecimens are essential to medical progress, but just medical waste to patients. Let's promote the science. From the op-ed: Many aspects of Ms. Lacks’s story reflect genuine injustice: the racism that characterized the…

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Institutions as an Ethical Locus of Research Prioritisation

Journal of Medical Ethics, April 11, 2017 (Online)
Luke Gelinas (Fellow in Clinical Research Ethics), Holly Fernandez Lynch (Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director)

Introduction Ensuring that clinical trials, once launched, successfully complete and generate useful knowledge is an important and indeed ethically imperative goal, given the risks and burdens borne by research participants.…

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Scott Gottlieb’s FDA Commissioner Confirmation Hearing: Remarkably Unremarkable

Health Affairs Blog, April 7, 2017
Rachel E. Sachs (Academic Fellow Alumna)

From the post: On Wednesday morning, the United States Senate Committee on Health, Energy, Labor, and Pensions conducted the confirmation hearing for Dr. Scott Gottlieb, President Trump’s nominee to be the next Commissioner of the Food & Drug Administration…

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Prohibiting sperm donor anonymity in the US and possible effects on recruitment and compensation

BioNews, April 3, 2017
Andrew Hellman and I. Glenn Cohen (Faculty Director)

From the article: Many children conceived using donor sperm or eggs want to know their biological parents. In the US, some clinics make the identity of the sperm donor available to a donor-conceived child at age 18. Most intending parents,…

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An FDA Commissioner for the 21st Century

NEJM, March 29, 2017
Amitabh Chandra and Rachel E. Sachs (Academic Fellow Alumna)

President Donald Trump has named Scott Gottlieb as his nominee to be the next commissioner of the Food and Drug Administration (FDA). As compared with some of the other people whose names were floated publicly for the position, Gottlieb is a traditional choice, a physician who served in a deputy commissioner…

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Regulating Black-Box Medicine

Michigan Law Review, March 21, 2017
W. Nicholson Price II (Academic Fellow Alumnus)

From the abstract: Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process…

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The Purpose of My Death: Death, Dying, and Meaning

Ethics, Vol. 127, no. 3, April 2017
Frances Kamm (Senior Fellow Alumna)

From the article: My purpose in this essay is to consider some views about death and dying presented in two recent books. One book is Death by philosopher Shelly Kagan and the second is Being Mortal by medical doctor Atul Gawande. I focus on their different views…

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Time is Money: An Empirical Assessment of Non-Economic Damages Arguments

Washington University Law Review, Forthcoming; U Denver Legal Studies Research Paper No. 16-21; Arizona Legal Studies Discussion Paper No. 16-12, March 2, 2017
John E. Campbell, Bernard Chao, and Christopher T. Robertson (Academic Fellow Alumnus)

From the abstract: Non-economic damages (pain and suffering) are the most significant and variable components of liability. Our survey of 51 U.S. jurisdictions shows wide heterogeneity in whether attorneys may quantify damages as time-units of suffering (“per…

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UPCOMING! Annual Health Law Conference: Between Complacency & Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases

Northeastern University School of Law, April 14, 2017
Holly Fernandez Lynch (Executive Director)

From the event:  Emerging infectious diseases (EIDs) such as Ebola and the Zika virus pose potentially grave threats to human health. They can also incite overreations that lead to the scapegoating of vulnerable populations and counter-productive public health…

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The NFL Combine: Pro football’s intrusive, and mandatory, job interview

Washington Post, February 26, 2017
Rick Maese, quoting Glenn Cohen (Faculty Director)

From the article: While there could be a gray area between tests that measure performance and those that examine health, Glenn Cohen, a Harvard law professor who co-authored the study, says the list of questionable exams the NFL requires of draft prospects is long:…

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Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations

The American Journal of Bioethics, Volume 17, 2017 - Issue 3
Luke Gelinas, Robin Pierce, Sabune Winkler, I. Glenn Cohen, Holly Fernandez Lynch, and Barbara Bierer

Part of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical…

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Mitochondrial Replacement Therapy: Unmade in the USA

The JAMA Forum, February 14, 2017
Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

From the article: Mitochondrial replacement therapy, an experimental approach that takes aim at maternally inherited mitochondrial diseases, is on the verge of being implemented in the United Kingdom, almost 2 years after it received approval from the UK Parliament.…

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Common Rule Revisions: Impact of Public Comment, and What’s Next?

The Hastings Center Blog, February 8, 2017
By Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director) and Barbara E. Bierer

From the blog post: On January 19, the day the final revisions to the Federal Policy for the Protection of Human Subjects were published in the Federal Register, our essay “Public Engagement, Notice-and-Comment Rulemaking, and the Common Rule”…

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Advanced and end of life care: cautionary suggestions

Journal of Medical Ethics, February 7, 2017 (online)
Frances Kamm (former Senior Fellow)

Abstract: This article considers some clinical and population level approaches to advanced care of chronic conditions and end of life care. One approach aims to follow patient values and preferences about acceptable end of life (EOL) as elicited by questionnaires. The grounds…

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A New Day For Oversight Of Human Subjects Research

HealthAffairs, February 6, 2017
Holly Fernandez Lynch (Executive Director)

Editor’s note: This post is part of a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23rd,…

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Evaluating NFL Player Health and Performance: Legal and Ethical Issues

University of Pennsylvania Law Review, Vol. 165, No. 2, 2017
Jessica L. Roberts, I. Glenn Cohen (Faculty Director), Christopher R. Deubert (Senior Law & Ethics Associate), and Holly Fernandez Lynch (Executive Di

Abstract:       This Article follows the path of a hypothetical college football player with aspirations to play in the National Football League, explaining from a legal and ethical perspective the health and performance evaluations he will likely…

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Traveling for Assisted Suicide

In Euthanasia and Assisted Suicide: Global Views on Choosing to End Life (Michael J. Cholbi, ed.), Praeger, 2017 (forthcoming)
I. Glenn Cohen (Faculty Director)

This book addresses key historical, scientific, legal, and philosophical issues surrounding euthanasia and assisted suicide in the United States as well as in other countries and cultures. Euthanasia was practiced by Greek physicians as early as 500 BC. In the 20th century, legal and ethical…

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Bioethics in the law

The Hastings Center Report, January/February 2017, Vol. 47, Issue 1
Zachary E. Shapiro (Student Fellow Alumnus)

Abstract The role of law in bioethics is clear. Laws are enforcement tools: they govern which conditions qualify an individual for disability benefits, or what oversight is necessary for clinical trial protocols, or how patent applications for medical devices should be regulated.…

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