Preventing Mitochondrial Disease: A Path Forward

Obstetrics & Gynecology, March 2018 - Volume 131 - Issue 3
Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

Abstract: In a possible first, the heritable transmission of a fatal mitochondrial DNA disease (Leigh syndrome) may have been prevented by replacing the mutation-bearing mitochondria of oocytes with donated mutation-free counterparts. The procedure, carried out by a U.S.-led…

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A Framework for Ethical Payment to Research Participants

NEJM, February 22, 2018
Luke Gelinas (Senior Researcher), Emily A. Largent, I. Glenn Cohen (Faculty Director), Susan Kornetsky, Barbara E. Bierer, and Holly Fernandez Lynch

Members 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…

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Delinking Reimbursement

Minnesota Law Review, Forthcoming, February 14, 2018
Rachel Sachs (Academic Fellow Alumna)

From the article: Over the past few years, calls for the Food and Drug Administration (FDA) to approve pharmaceuticals more speedily have grown louder. At the same time, many have argued that America’s drug pricing problems can be solved if only Congress were…

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Reforming Biopharmaceutical Pricing at Home and Abroad

Executive Office of the President of the United States, February 2018
The Council of Economic Advisers, citing work by Rachel Sachs (Academic Fellow Alumna)

From the article: The affordability of healthcare and biopharmaceutical drugs is a top concern for Americans. It is often asserted that promoting innovation and affordable drugs are conflicting goals. New innovations, however, often provide improved health that was…

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Harvard Law to Explore Legal Complexities of Precision Medicine, AI

Healthcare Analytics News, February 1, 2018
Ryan Black, featuring the Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL)

From the article: Precision medicine and artificial intelligence (AI) are complicated by design: Both scientific fields rely on extreme specificity, complex equations, and forces that can’t be seen. As both fields begin to alter the healthcare landscape,…

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The Regulatory Accountability Act of 2017 — Implications for FDA Regulation and Public Health

NEJM, February 1, 2018
Jonathan J. Darrow (Student Fellow Alumnus), Erin C. Fuse Brown, and Aaron S. Kesselheim

From the article: In the past year, federal health policy has been characterized by pervasive uncertainty, but a consistent theme from the Trump administration and some prominent legislators has been opposition to regulation. Last spring, Congress took a substantial…

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You can love the brain and football, too

StarTribune, January 31, 2018
Francis X. Shen (Senior Fellow)

Check out the new op-ed from Francis X. Shen, Senior Fellow in Law and Neuroscience at the Project…

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Pharmaceutical Advertising in Medical Journals

CHEST, Volume 153, Issue 1
Michael S. Sinha, Aaron S. Kesselheim, and Jonathan J. Darrow (Student Fellow Alumnus)

From the article: Marketing efforts across many industries, including the health-care industry, have shifted toward digital advertising through web-based, social media, and mobile application platforms. Still, as recently as 2015, the health-care industry expended…

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Petrie-Flom Center launches Project on Precision Medicine, Artificial Intelligence, and the Law

Harvard Law Today, January 31, 2018
Q & A with I. Glenn Cohen (Faculty Director)

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen recently announced a new collaboration, the Project on Precision Medicine, Artificial…

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PFC Spotlight: Academic Fellow Alumnus Matthew J. B. Lawrence

Petrie-Flom Center , January 31, 2018

Matthew J. B. Lawrence was an Academic Fellow from 2010-2013, during which time his research focused on health care reform and health insurance coverage…

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The Petrie-Flom Center Launches the Innovative Funding Models in Translational Research Project

The Petrie-Flom Center, January 29, 2018

January 30, 2018 - The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is launching the

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The Federal Right to Try Act of 2017: A Wrong Turn for Access to Investigational Drugs and the Path Forward

JAMA Internal Medicine, January 22, 2018
Alison Bateman-House and Christopher T. Robertson (Academic Fellow Alumnus)

From the article: In 2017, President Trump said that “one thing that’s always disturbed”1 him is that the US Food and Drug Administration (FDA) denies access to experimental drugs even “for a patient who’s terminal…[who] is…

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The Petrie-Flom Center Launches New Project: Precision Medicine, Artificial Intelligence, and the Law (PMAIL)

Petrie-Flom Center, January 23, 2018

The Project on Precision Medicine, Artificial Intelligence, and the Law will seek to better understand the frontiers of big data in health care diagnostics, through interdisciplinary analysis of important health law and policy issues. January 23, 2018 –…

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Cops, Docs, and Code: A Dialogue between Big Data in Health Care and Predictive Policing

UC Davis Law Review, Vol. 51, No. 437, 2017
I. Glenn Cohen (Faculty Director) and Harry Graver

Abstract: “Big data” has become the ubiquitous watchword of this decade. Predictive analytics, which is something we want to do with big data -- to use of electronic algorithms to forecast future events in real time. Predictive analytics is interfacing…

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Patient-Centered Outcomes Research: Stakeholder Perspectives and Ethical and Regulatory Oversight Issues

The Hastings Center, January-February 2018
Emily A. Largent (Student Fellow Alumna), Joel S. Weissman, Avni Gupta, Melissa Abraham, Ronen Rozenblum, Holly Fernandez Lynch (Academic Fellow Alumn

Abstract:  The Patient-Centered Outcomes Research Institute (PCORI), the leading research institute in the United States for patient-centered outcomes research (PCOR), funded our multiyear mixed-methods project, the Patient Centered Outcomes Research Oversight Study, to begin systematically…

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It’s time to levy penalties for failing to report clinical trial results

STAT, January 17, 2018
Holly Fernandez Lynch (Academic Fellow Alumna and former Executive Director)

From the article: I started my first job as an attorney in the fall of 2007, days after President George W. Bush signed the Food and Drug Administration Amendments Act (FDAAA) into law. As part of my firm’s FDA group, my job was to figure out what…

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Tip of the Iceberg II: How the Intended-Uses Principle Produces Medical Knowledge and Protects Liberty

11 NYU Journal of Law & Liberty 770, January 12, 2018
Christopher T. Robertson (Academic Fellow Alumnus) and Victor Laurien

Abstract In recent years, the Food and Drug Administration’s pre-market approval process has come under increasing scrutiny as an infringement on liberty and a regulation of speech. In the first part of this symposium contribution, we offer a case study of Seroquel XR, showing how the…

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A New Approach to Treat Childhood Leukemia: Novartis’ CAR-T Therapy

The Journal of Law, Medicine & Ethics, January 10, 2018
Frazer A. Tessema and Jonathan J. Darrow (Student Fellow Alumnus)

From the article: On August 30, 2017, the US Food and Drug Administration (FDA) announced the approval of tisagenlecleucel (Kymriah; CTL019), Novartis' new treatment for B-cell acute lymphoblastic leukemia (ALL) in children or young adults who are either unresponsive…

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Federal Right-to-Try Legislation — Threatening the FDA’s Public Health Mission

NEJM, January 10, 2018
Steven Joffe and Holly Fernandez Lynch (Academic Fellow Alumna and former Executive Director)

From the article: The Food and Drug Administration (FDA) is the gatekeeper of the country’s drugs and medical devices. Originally created to prevent the misleading of patients, it was later tasked with ensuring the safety of medical products. In 1962, Congress…

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Drug Policy: The Year In Review, And The Year Ahead

Health Affairs Blog, January 4, 2018
Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Last year was an unquestionably busy time for health care news of all kinds. Media and policy coverage rightly focused on the many attempts to repeal the Affordable Care Act, but it was also…

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