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

Annals of Internal Medicine, November 20, 2018
I. Glenn Cohen (Faculty Director), Dov Fox, and Eli Y. Adashi

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 “preembryos”) that were…

Read More

Expansion of the Medicare 340B Payment Program

JAMA, November 16, 2018
Peter B. Bach and Rachel E. Sachs (Academic Fellow Alumna)

From the article:  "The 340B program began as a means to lower the cost of outpatient medications for a small set of underresourced health care facilities that served primarily low-income patients, although sequential changes in the program over…

Read More

Machine learning in medicine: Addressing ethical challenges

PLOS Medicine, November 6, 2018
Effy Vayena, Alessandro Blasimme, and I. Glenn Cohen (Faculty Director)

From the article:  A recent United Kingdom survey reports that 63% of the adult population is uncomfortable with allowing personal data to be used to improve healthcare and is unfavorable to artificial intelligence (AI) systems replacing doctors…

Read More

The Health 202: There will be a big fight over Trump’s new proposal to lower drug prices

Washington Post, October 26, 2018
Paige Winfield Cunningham, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: But the plan does signify the administration is serious about taking action on drug prices. The Obama administration made a similar effort, which it ultimately abandoned under pressure from the drug industry.

Read More

Administration Outlines Plan To Lower Pharmaceutical Prices In Medicare Part B

Health Affairs, October 26, 2018
Rachel Sachs (Academic Fellow Alumna)

From the article: Yesterday, the Trump Administration outlined a plan that, if implemented, could significantly lower the prices of pharmaceuticals through Medicare Part B. The plan contains three key elements: substituting private-sector…

Read More

Conflicts of interest and the (in)dependence of experts advising government on immunization policies

Vaccine, October 22, 2018
Jean-Christophe Bélisle-Pipon (Visiting Scholar), Louise Ringuette, Anne-Isabelle Cloutier, Victoria Doudenkova, and Bryn Williams-Jones

From the article: There has been increasing attention to financial conflicts of interest (COI) in public health research and policy making, with concerns that some decisions are not in the public interest. One notable problematic area is expert advisory…

Read More

Response to Open Peer Commentaries on “The Ethics of Smart Pills and Self-Acting Devices: Autonomy, Truth-Telling, and Trust at the Dawn of Digital Medicine”

American Journal of Bioethics, Volume 18, October 2018
Craig M. Klugman, Laura B. Dunn, Jack Schwartz and I. Glenn Cohen (Faculty Director)

From the article:  We thank all of the insightful authors who wrote open peer commentaries to further the conversation about digital medicine that we raised in our article, “The Ethics of Smart Pills and Self-Acting Devices: Autonomy, Truth-Telling,…

Read More

Protecting Clinical Trial Participants and Study Integrity in the Age of Social Media

Cancer, October 17, 2018
Holly Fernandez Lynch, Emily A. Largent, Steven Joffe, and Angela M. DeMichele

From the article: Social media communication among clinical trial participants has the potential to pose risks to their safety and to trial integrity. The Social Media ADEPT framework may help mitigate that potential by encouraging investigators and…

Read More

Patient‐Engaged Research: Choosing the “Right” Patients to Avoid Pitfalls

Hastings Center Report, October 11, 2018
Emily A. Largent, Holly Fernandez Lynch, Matthew S. McCoy

From the article: To ensure that the information resulting from research is relevant to patients, the Patient‐Centered Outcomes Research Institute eschews the “traditional health research” paradigm, in which investigators drive all…

Read More

Early career researchers’ perspectives and roles in patient-oriented research

Research Involvement and Engagement, October 9. 2018
Geneviève Rouleau, Jean-Christophe Bélisle-Pipon (Visiting Researcher), et al.

Complete author list:  Geneviève Rouleau, Jean-Christophe Bélisle-Pipon, Stanislav Birko, Philippe Karazivan, Nicolas Fernandez, Karine Bilodeau, Yi-Sheng Chao, Alexandra de Pokomandy,…

Read More

When Markets Fail: Patents and Infectious Disease Products

Food and Drug Law Journal, September 2018, Volume 73, Number 3
Jonathan J. Darrow, Michael S. Sinha, and Aaron S. Kesselheim

From the abstract:  New antibiotics and vaccines aimed at treating or preventing infectious diseases can be highly valuable public health innovations, particularly when these products address unmet medical needs. Although patents are considered the primary…

Read More

Petrie-Flom Center and Edmond J. Safra Center for Ethics Fellow-in-Residence: The Ethics of Technological and Biomedical Innovation

Petrie-Flom Center, Applications Due: November 15, 2018

Each year the Edmond J. Safra Center for Ethics at Harvard University hosts several fellows-in-residence. For 2019-20, they are concentrating their fellowships on the Ethics of Technological…

Read More

Oversight of Patient-Centered Outcomes Research: Recommendations From a Delphi Panel

Annals of Internal Medicine, September 25, 2018
Luke Gelinas (Senior Fellow), Joel S. Weissman, Holly Fernandez Lynch, Avni Gupta, Ronen Rozenblum, Emily A. Largent,I. Glenn Cohen (Faculty Director)

From the abstract:  A key aim of patient-centered outcomes research (PCOR) is to generate data that are important to patients by deliberately and extensively involving them in all aspects of research, from design to dissemination. However, certain…

Read More

The Ethics of Smart Pills and Self-Acting Devices: Autonomy, Truth-Telling, and Trust at the Dawn of Digital Medicine

American Journal of Bioethics, September 20, 2018
Craig M. Klugman, Laura B. Dunn, Jack Schwartz, and I. Glenn Cohen (Faculty Director)

From the abstract:  Digital medicine is a medical treatment that combines technology with drug delivery. The promises of this combination are continuous and remote monitoring, better disease management, self-tracking, self-management of diseases, and improved…

Read More

Smart pills can transmit data to your doctors, but what about privacy?

New Scientist, September 19, 2018
I. Glenn Cohen (Faculty Director) and Alex Pearlman (Communications Manager)

From the article:  Abilify MyCite, a pill-app combination that can be used to track the ingestion of drugs for bipolar disorder and schizophrenia, was the first such product approved by the US Food and Drug Administration (FDA), in November 2017. Its roll-out…

Read More

Limiting State Flexibility in Drug Pricing

NEJM, September 13, 2018
Nicholas Bagley and Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that…

Read More

Are Fraud and Abuse Laws Stifling Value-Based Care?

NEJM Catalyst , September 12, 2018
Carmel Shachar (Executive Director)

From the article:  While health care delivery and financing should not be a free-for-all, designing the exemptions to explicitly conform to specific regulatory programs does not best serve the system. Even when a medical provider decides that a value-based care…

Read More

Listening to NFL Players On Mental Health: New report highlights key findings from interviews with players and family members

Journal of Clinical Sport Psychology, Volume 12 Issue 3, September 2018
Sarah A. McGraw, Christopher R. Deubert, Holly Fernandez Lynch, Alixandra Nozzolillo, Lauren Taylor, I. Glenn Cohen (Faculty Director)

When it comes to their careers, current and former NFL players express satisfaction – and frustrations – about their lives both on and off the field. “Life on an Emotional Roller Coaster: NFL Players and Their Family Members’ Perspectives on Player Mental Health” covers…

Read More

In whose best interests: The impact of globalised medicine on on withdrawal of treatment decisions in the UK

New Law Journal, September 7, 2018
David Locke & Carmel Shachar (Executive Director)

From the paper: As a feature of the progressive globalisation of medicine, the recent, heavily litigated, trio of cases involving the withdrawal of treatment from infants (Charlie Gard, Isiah Haastrup and Alfie Evans) has highlighted what is asserted…

Read More

The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents

Applied Health Economics and Health Policy, August 2018, Vol. 14, Issue 73
Jonathan J. Darrow (Student Fellow Alumnus), Reed F. Beall, Aaron S. Kesselheim

From the abstract:  Background Most new brand-name drugs are protected by patents from generic competition, but these patents are occasionally granted in error. Invalidating such patents has traditionally been…

Read More