AVAILABLE FOR PRE-ORDER! Transparency in Health and Health Care in the United States

Cambridge University Press, Forthcoming June 2019
Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, and Barbara J. Evans (eds.)

This edited volume stems from the Petrie-Flom Center’s 2017 annual conference, which brought together leading experts to reach better understandings of this health policy buzzword,…

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The Ethics of Heritable Genome Editing: New Considerations in a Controversial Area

JAMA, December 3, 2018
Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

From the article:  Editing the genome of human gametes or embryos is a disruptive unactualized technology and continues to be the subject of a wide range of concerns. The chief concern is the safety and efficacy of such an intervention and…

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On Repugnance, Distribution, and the Global Kidney Exchange: Comment

Journal of Institutional and Theoretical Economics (JITE), November 27, 2018
I. Glenn Cohen (Faculty Director)

From the article:  Krawiec opens the article by quoting Alvin Roth’s framing of repugnance as a “distaste for certain kinds of transactions [that] can be a real constraint on markets and how they are designed” (Roth, 2007, p.…

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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…

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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…

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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…

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Trump prescription medication plan drawing skepticism

Boston Herald, November 3, 2018
Alexi Cohan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Part of the proposal includes adopting an international pricing index for reimbursement that is based off the cost of certain drugs in other countries. This would lower the cost here in the United States, which can drop out-of-pocket expenses…

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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.

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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…

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Trump leans into midterms with a pitch to un-rig Medicare drug prices

CNN Politics, October 25, 2018
Tami Luhby and Lauren Fox, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  While Trump officials could use an Obamacare-created innovation center to pilot new payment proposals, it would have to take a hard stance on prices. "We don't negotiate because we don't use the threat of walking…

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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…

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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,…

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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…

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Pharma’s new plan to put more info — but not drug list prices — in TV ads

Vox, October 15, 2018
Dylan Scott, quoting Rachel Sachs

From the article: Policy experts were already unimpressed with the Trump administration’s idea of requiring list prices to be included in ads, mostly because there is no real mechanism to lower prices here. It…

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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…

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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,…

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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…

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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…

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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…

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Big questions raised by big data: Berkman Klein and Petrie-Flom centers co-sponsor book launch event on big data, health law and bioethics

Harvard Law Today, September 20, 2018
Lewis Rice, featuring Carmel Shachar (Executive Director) and I. Glenn Cohen (Faculty Director)

From the article:  During the introduction to the book launch event for “Big Data, Health Law, and Bioethics,” one of the editors, Harvard Law School Professor I. Glenn Cohen ’03, faculty director of the Petrie-Flom Center…

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