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Podcasts now available! 2020 Petrie-Flom Center Annual Conference: Innovation and Protection: The Future of Medical Device Regulation

May 8, 2020

Notice of Revision In light of developments with COVID-19, we converted our annual conference into a series of podcasts interviewing our contributors.Check out the episodes on This Week in…

Ethical Dilemmas in Mask and Equipment Shortages image

Ethical Dilemmas in Mask and Equipment Shortages: Health Care During the COVID-19 Pandemic

April 22, 2020
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Online Viewing Fully captioned video of the panel discussion and panelists' slide presentations below! Join the conversation on Twitter: @PetrieFlom #PPEethics! Event Description Personal protective equipment or PPE has been…

As Second U.S. Death Reported Out Of Washington Nursing Facility, Fears Mount For Vulnerable Elderly Population

Kaiser Health News

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Authorities in the Seattle area reported four new cases Sunday night. Researchers say that it's likely the…

How Chaos at Chain Pharmacies Is Putting Patients at Risk: Pharmacists across the U.S. warn that the push to do more with less has made medication errors more likely. “I am a danger to the public,” one wrote to a regulator.

Ellen Gabler
New York Times

In letters to state regulatory boards and in interviews with The New York Times, many pharmacists at companies like CVS, Rite Aid and Walgreens described understaffed and chaotic workplaces where…

Several ‘Best’ U.S. Hospitals Penalized Over Too-High Rates Of Infection, Injury

Jordan Rau
NPR

Hundreds of hospitals across the U.S., including a number with sterling reputations for cutting-edge care, will be paid less by Medicare after the federal government pronounced that they had…

Hospitals Merged. Quality Didn’t Improve.: The quality of care at hospitals acquired during a recent wave of deal making got worse or stayed the same, new research found

Melanie Evans
Wall Street Journal

This article is behind a paywall. Harvard affiliates can access the full text via Hollis. The quality of care at hospitals acquired during a recent wave of deal making got…

Medical Device Failures Brought To Light Now Bolster Lawsuits And Research

Christina Jewett
Kaiser Health News

[...] For almost 20 years, malfunctions and injuries linked to 108 medical devices, including dental implants and pacemaker leads, were funneled into an FDA database that few patients, doctors or even FDA officials…

Big study casts doubt on need for many heart procedures

Associated Press
STAT

PHILADELPHIA — People with severe but stable heart disease from clogged arteries may have less chest pain if they get a procedure to improve blood flow rather than just giving…

Health Law Workshop: Lewis Grossman: Choose Your Medicine: Freedom of Therapeutic Choice in America

November 11, 2019

Presentation Topic: "Choose Your Medicine: Freedom of Therapeutic Choice in America" This presentation is not available for download. About the Presenter Lewis Grossman is Professor of Law at American University'…

Diagnostic Gaps: Skin Comes In Many Shades And So Do Rashes

Deena Prichep
NPR

[...] Dr. Lynn McKinley-Grant, a dermatology professor at Howard University and president of the Skin of Color Society, says that's not just a problem with websites aimed at patients. "Often…

J&J Hit With $8 Billion Jury Award Over Antipsychotic Drug: J&J is expected to appeal punitive damages award to a man who alleged Risperdal caused enlarged breasts

Peter Loftus
Wall Street Journal

This article is behind a paywall. Harvard affiliates can access the full text via Hollis. A Philadelphia jury on Tuesday ordered Johnson & Johnson to pay $8 billion in damages to…

Young people are poisoning themselves at alarming rates with over-the-counter drugs: There’s been a dramatic uptick in self-poisonings, particularly among girls and young women. There are ways to help.

Brian Resnick
Vox

[...] researchers say there aren’t great guidelines around how families should deal with keeping kids away from over-the-counter drugs or prescriptions that belong to other family members. “We…

Book Launch: Transparency in Health and Health Care in the United States

September 16, 2019
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Description In June 2019, Cambridge University Press published Transparency in Health and Health Care in the United States. This volume, edited by Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, and…

Scientific Merit Predicates Ethical Review of Clinical Research

Barbara E. Bierer and Luke Gelinas
Ethics and Human Research

From the article: In the United States, federal regulations codified by the Department of Health and Human Services in the “Common Rule”1 address the conduct and oversight of…

2019 Petrie-Flom Center Annual Conference: Consuming Genetics: Ethical and Legal Considerations of New Technologies

May 17, 2019
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Couldn't join us for the conference? Join the conversation on Twitter with #DTCgenome! And check out many of our speakers' slide presentations and our "Consuming Genetics" blog symposium! The…

The Ethics of Cancer Screening: When Should We Screen and When Should We Not?: A Health Policy and Bioethics Consortium

May 10, 2019

Description There is substantial debate over whether and how we should screen the general population to detect cancers such as breast, prostate, and colon cancer. The principle of early detection…

Accelerating Alternatives to Animal Experimentation

March 1, 2019

This panel gave an overview of the current state of developing alternatives to animal use in science and research, before then discussing whether an “accelerator” type business model…

Losing Embryos, Finding Justice: Life, Liberty, and the Pursuit of Personhood

I. Glenn Cohen (Faculty Director), Dov Fox, and Eli Y. Adashi
Annals of Internal Medicine

From the article: On 3 March 2018, a liquid nitrogen storage tank broke down at University Hospitals Fertility Center in Cleveland, Ohio. More than 950 patients lost over 4000 eggs and embryos (also called …

Provider Consolidation: Implications for Costs and Quality in Health Care Delivery: A Health Policy and Bioethics Consortium

November 9, 2018

In the last decade, the traditional conception of individual physicians or medical groups has been increasingly replaced by consolidation under academic medical centers and other national or regional administrative organizations.…

Health Law Workshop: John Tingle

November 5, 2018

Presentation Presentation now available: "Patient Safety Policy Development in the NHS in England" This presentation is based on a chapter in Global Patient Safety: Law, Policy and Practice, edited by…

Bad Blood: Secrets and Lies in a Silicon Valley Startup: A Special Evening with Author John Carreyrou

October 2, 2018

This event featured moderated discussion with John Carreyrou, investigative reporter for the Wall Street Journal and author of the New York Times bestseller Bad Blood: Secrets and Lies in a…

Health Law Workshop: Timothy Caulfield

September 10, 2018

Presentation Download the Presentation: "Health Misinformation and the Power of Narrative Messaging in the Public Sphere" Background Reading: Timothy Caulfield, "Elle Macpherson, 'anti-vaxx' nonsense, and the opportunity to engage," BMJ (2018). …

We Have to Be Smart About Artificial Intelligence in Medicine: When the technology is complicated, opaque, changing, and absolutely vital to the health of a patient, how do we make sure it works as promised?

W. Nicholson Price II (Academic Fellow Alumnus)
Slate

From the article: For millions of people suffering from diabetes, new technology enabled by artificial intelligence promises to make management much easier. Medtronic’s Guardian Connect system promises to…

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

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

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: On May 30, 2018, President Trump…

Criticism of ‘right to try’ law for experimental drugs after it passes in US

Anthony King, quoting Jonathan J. Darrow (Student Fellow Alumnus)
Chemistry World

From the article: The US government has controversially announced that it will allow unapproved, experimental drugs to be given to terminally ill patients. The ‘right to try’ law…

Circumvention Medical Tourism and Cutting Edge Medicine: The Case of Mitochondrial Replacement Therapy

I. Glenn Cohen (Faculty Director)
Indiana Journal of Global Legal Studies

From the article: “Medical Tourism” is the travel of patients from a home country to a destination country for the primary purpose of receiving health care. “Circumvention…

House passes right-to-try on second try

Sarah Karlin-Smith, quoting Christopher T. Robertson (Academic Fellow alumnus)
Politico

From the Article: The House of Representatives passed on party lines Wednesday evening a bill designed to let very sick patients request access to experimental medicines without government oversight. The…

Risk and Resilience in Health Data Infrastructure

W. Nicholson Price II (Academic Fellow Alumnus)
Colorado Technology Law Journal

From the journal article: Today’s health system runs on data. However, for a system that generates and requires so much data, the health care system is surprisingly bad…

The Conduct of Clinical Trials of Treatments during Public Health Emergencies: A Health Policy and Bioethics Consortium

February 9, 2018
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Couldn't join us for the event? Check out the panelists' slide presentations below! Description In the past several years, the United States has struggled to respond to viral outbreaks,…

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

Steven Joffe and Holly Fernandez Lynch (Academic Fellow Alumna and former Executive Director)
NEJM

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…

Health Law Workshop: Thaddeus Mason Pope

November 20, 2017

Presentation Download the Presentation: "From Informed Consent to Shared Decision Making: How Patient Decision Aids Can Improve Patient Safety and Reduce Medical Liability Risk" Background Reading: "Certified Patient Decision Aids:…

Book Launch: Specimen Science: Ethics and Policy Implications

November 9, 2017

In September 2017, MIT Press will publish Specimen Science: Ethics and Policy Implications, co-edited by Holly Fernandez Lynch (outgoing Petrie-Flom Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director), and Suzanne…

Your Money or Your Patient’s Life? Ransomware and Electronic Health Records

By I. Glenn Cohen (Faculty Director), Sharona Hoffman, and Eli Y. Adashi
Annals of Internal Medicine

The mugger's demand “Your money or your life” is a familiar one. However, in an era of vast hospital computer networks and electronic health records, a novel…

Medical Tourism, Medical Migration, and Global Justice: Implications for Biosecurity in a Globalized

I. Glenn Cohen (Faculty Director)
Medical Law Review

From the paper: We live in the age of globalization. In medicine, that globalization has brought many benefits such as the diffusion of technology and the spread of health care…

Medical Errors and the Culture of Medicine: A Health Policy and Bioethics Consortium

April 14, 2017

Panelists Martin Makary, MD, MPH, Professor of Surgery, Johns Hopkins University School of Medicine; Professor of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health Timothy Hofer, MD,…

An FDA Commissioner for the 21st Century

Amitabh Chandra and Rachel E. Sachs (Academic Fellow Alumna)
NEJM

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…

Travel Abroad for Low-Cost Care: You could save money on cosmetic surgery, dental procedures and other treatments by traveling to another country.

Miriam Cross, quoting I. Glenn Cohen (Faculty Director)
Kiplinger's Personal Finance

From the article: Why the extra effort to court foreign patients? A couple of reasons, according to Patients With Passports (Oxford University Press), by I. Glenn Cohen: to make money …

Senate committee calls for ban on surgeons conducting simultaneous operations

Jonathan Salzman and Jenn Abelson
Boston Globe

From the article: A powerful Senate committee wants all hospitals to explicitly ban surgeons from overseeing two simultaneous operations, weighing in on a controversy that has roiled Massachusetts General Hospital…

The Animal Welfare Act at 50

December 2-3, 2016

Overview The Animal Law & Policy Program at Harvard Law School hosted The Animal Welfare Act at Fifty, a conference that brought experts together to assess the first fifty years…

Concurrent Surgeries: Medical, Legal, and Ethical Issues

October 27, 2016
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Couldn't attend the event? Check out selected speakers' slide presentations! Concurrent, or overlapping, surgeries involve the simultaneous scheduling of substantial portions of two or more surgeries under the supervision…

Is Medical Tourism Ethical?: Profile of I. Glenn Cohen's work as a Greenwall Foundation Faculty Scholar

The Greenwall Foundation

Petrie-Flom Faculty Director I. Glenn Cohen served as a Greenwall Foundation Faculty Scholar, Class of 2015. The Greenwall Foundation recently published a profile of Cohen's project, "Is Medical Tourism Ethical?": …

EpiPen’s Dominance Driven By Competitors’ Stumbles And Tragic Deaths

Pauline Bartolone, quoting W. Nicholson Price II (Academic Fellow alumnus)
NPR

NPR recently called on Petrie-Flom Academic Fellow alumnus Nicholson Price to help explain how Mylan's Epi-Pen has come to dominate the market for epinephrine autoinjectors. From the article: The…

FDA Regulations Limit Blood Donations From Gay Men

Holly Quan, featuring I. Glenn Cohen (Faculty Director)
CBS San Francisco

Excerpt from the article: On World Blood Donation Day and in the wake of the Orlando mass shooting, a leading bioethicist Tuesday called for a change in the FDA&rsquo…

After The Orlando Massacre, Many In The LGBTQ Community Are Turned Away From Giving Blood

Nikki Blank, interviewing I. Glenn Cohen (Faculty Director)
Greater Boston (WGBH)

Excerpt from interview: Early in the 1980's, there was a lifetime ban or deferral for any man who had ever had sex with another man. Even once. But in May,…

Review: I Glenn Cohen, Patients with Passports: Medical Tourism, Law, and Ethics, Oxford University

Reviewed by Douglas MacKay
Kennedy Institute of Ethics Journal

From the review: Glenn Cohen’s Patients with Passports: Medical Tourism, Law, and Ethics offers a thorough examination of the growing practice of medical tourism, the legal regulations governing…

Health Law Workshop: Robert Cook-Deegan

April 18, 2016

About the Presenter Robert Cook-Deegan is a research professor in the Sanford School of Public Policy at Duke University, with secondary appointments in Internal Medicine (School of Medicine), and Biology …

Fourth Annual Health Law Year in P/Review

January 29, 2016
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Couldn't attend in person? Learn more about the event: Learn more about the presentations - check out select speakers' slides below! Check out the collaborative blog series on the…

A Conversation with Margaret A. Hamburg, FDA Commissioner 2009-2015

January 20, 2016
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Description The Petrie-Flom Center hosted a conversation with former FDA Commissioner (and former New York City Health Commissioner), Dr. Margaret A. Hamburg, led by Peter Barton Hutt, former Chief Counsel…

Robust Exclusion and Market Division Through Loyalty Discounts

By Einer Elhauge (Founding Faculty Director) and Abe Wickelgren
Harvard Public Law Working Paper No. 14-12

Founding Faculty Director Einer Elhauge has coauthored an article Abe Wickelgren on loyalty discounts, which are often used in pharmaceutical and medical device markets. The article was awarded Best Academic…

Petrie-Flom Event Review:: Experts Talk Vaccine Opt-Out Parameters

Gabrielle M. Williams
Harvard Crimson

There is a delicate balance between preserving individual rights and protecting public health when it comes to vaccines, experts argued at a panel discussion at Harvard Law School on Wednesday. [...] …

Measles, Vaccines, and Protecting Public Health

February 25, 2015
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Couldn't join us? Watch the full event online! For more on this event, check out the write-ups in the Harvard Gazette (February 27, 2015) and the Harvard Crimson (February 26, 2015)! The measles…

Patients with Passports: Medical Tourism, Law, and Ethics

Robert Klitzman, leading discussion with I. Glenn Cohen (Faculty Director)
Carnegie Council for Ethics in International Affairs

Live Webstream Watch the event live online! Description Medical tourism is a growing, multi-billion dollar industry involving millions of patients who travel abroad each year to get health care. Some…

Courts wrestle with wave of new state abortion laws

Paige Winfield Cunningham, quoting I. Glenn Cohen (Faculty Director)
Politico

[...] As courts weigh the legal challenges to these laws, they’re being asked to spell out exactly how far states can go in regulating abortion and what requirements go…

F.D.A. Easing Ban on Gays, to Let Some Give Blood

Sabrina Tavernise, quoting I. Glenn Cohen (Faculty Director)
New York Times

[...] “This is a major victory for gay civil rights,” said I. Glenn Cohen, a law professor at Harvard who specializes in bioethics and health. “We’re…

Traveling patients, traveling disease: Ebola is just the tip of the iceberg

I. Glenn Cohen (Faculty Director)
OUPblog

Many in the media and academia (myself included) have been discussing the Ebola crisis, and more specifically, the issues that arise as Ebola has traveled with infected patients and health…

Traveling Overseas for Medical Care

All Sides with Ann Fisher, interviewing I. Glenn Cohen (Faculty Director)
WOSU (NPR)

From the WOSU: All-inclusive vacations might feature a stay in a luxury hotel, gourmet meals, and in some cases, a hip replacement. Companies that specialize in medical tourism help patients…

Book Launch: Patients with Passports: Medical Tourism, Law, and Ethics

November 19, 2014
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I. Glenn Cohen's new book Patients with Passports: Medical Tourism, Law, and Ethics (Oxford University Press, 2014) is the first comprehensive legal and ethical analysis of medical tourism. Examining both…

Emerging Issues and New Frontiers for FDA Regulation

October 20, 2014

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute were pleased to announce this collaborative academic symposium. Agenda: …

FDA Regulation of Mobile Health Technologies

Nathan G. Cortez, J.D., I. Glenn Cohen, J.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H.
NEJM

Petrie-Flom Faculty Director I. Glenn Cohen has published a new co-authored article in the New England Journal of Medicine on FDA regulation of new mobile health technologies. From the article: …

Reconsideration of the Lifetime Ban on Blood Donation by Men Who Have Sex With Men

I. Glenn Cohen, JD (Faculty Director); Jeremy Feigenbaum, JD; Eli Y. Adashi, MD, MS
JAMA

Faculty Director I. Glenn Cohen has co-authored a new Viewpoint piece in the July 23/30, 2014 issue of JAMA, arguing for the end of the FDA's lifetime ban on blood donation…

Clinical Trials and the Right to Remain Silent

Michelle Mello, JD, PhD, MPhil and I. Glenn Cohen, JD (Faculty Director)
JAMA

I. Glenn Cohen has coauthored a new Invited Commentary piece in JAMA on access to clinical trial data. From the article: In this issue of JAMA Internal Medicine, Kernan et…

Direct-to-Patient Laboratory Test Reporting: Balancing Access With Effective Clinical Communication

Michael J. Young, MPhil (Petrie-Flom Student Fellow); Ethan Scheinberg, BTL; Harold Bursztajn, MD
JAMA

In February 2014, the Department of Health and Human Services (HHS) issued a landmark ruling allowing patients direct access to completed medical laboratory reports. The ruling took effect April 7, 2014, and gives…

Globalization and Healthcare Ethics

I. Glenn Cohen (Faculty Director)
@BioethxChat

Join Petrie-Flom Faculty Co-Director I. Glenn Cohen on May 19 as he leads a discussion on "Globalization and Healthcare Ethics" hosted by BioethxChat on Twitter.

FDA Advises Against Morcellator Use in Hysterectomies: Citing Cancer Risks, Overseer Discourages Use of Morcellators to Remove Uterine Growths

Jon Kamp and Jennifer Levitz, quoting I. Glenn Cohen (Faculty Director)
Wall Street Journal

[...] "The fact that the FDA released this warning makes it more likely that a doctor who went against it will be held to have practiced in a way below the…

VIDEO NOW AVAILABLE: Stem Cell Therapies:: Opportunities for Assuring the Quality and Safety of Unregulated Clinical Offerings

Co-organized by I. Glenn Cohen
Institute of Medicine

Stem cells hold tremendous potential to advance health and medicine. Through replacement of damaged cells and organs or supporting intrinsic repair, stem cell offer promising treatments for debilitating diseases and…

Have Injury, Will Travel:: With medical costs exploding, young adventurers are opting to go under the knife overseas. Is the risk worth it?

Emily Matchar, quoting I. Glenn Cohen
Outside Magazine

[...] Most people who travel abroad for medical care are uninsured or underinsured, with high-copay or high-deductible insurance, says Glenn Cohen, a professor atHarvard Law School who studies medical tourism. [...]

The Globalization of Health Care: Book Talk and Discussion by Editor I. Glenn Cohen

September 24, 2013
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I. Glenn Cohen, Faculty Co-Director of the Petrie-Flom Center and Professor at Harvard Law School, discussed his new edited volume The Globalization of Health Care: Legal and Ethical Issues, published…

Stem Cell Therapy and Medical Tourism: Of Promise and Peril?

November 28, 2012

Experimental breakthroughs within the field of regenerative medicine are reported in the media on a daily basis worldwide. Despite this progress, the overwhelming majority of clinical problems for which stem…

Patients with Passports: Medical Tourism, Law and Ethics

October 10, 2012

Presenting as part of the 2012-2013 Radcliffe Fellows Series, Petrie-Flom Faculty co-Director I. Glenn Cohen discussed the growing phenomenon of medical tourism, the practice of citizens of one country traveling…