REPORT: Ethical Issues Related to the Creation of Synthetic Human Embryos

Harvard University Embryonic Stem Cell Research Oversight (“ESCRO”) Committee, April 2018

Report Summary Authored by Robert D. Truog, MD (Center for Bioethics, Harvard Medical School) and Melissa J. Lopes, JD…

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THE PRICE OF VACCINES MUST BE DISCLOSED, ORDERS A COURT

La Presse, April 19, 2018
Marie-Claude Malboeuf, Suit brought by Jean-Christophe Belisle Pipon (Visiting Researcher)

From the article: Pharmaceutical companies doing business with the government will no longer be able to hide how much money they are getting to provide vaccines. This is what the Commission for Access to Information (CAI) has just…

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Move over right-to-try: FDA looks at improving clinical trial enrollment

Politico, April 16, 2018
Sarah Karlin-Smith, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: The FDA’s bar for “breakthrough” designation may be too low, Harvard Medical School policy researchers argue in the New England Journal of Medicine. The designation was created by Congress in 2012 for new drugs that preliminary…

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Parenting of the future: Many embryos, each with DNA profile

The Washington Post , April 18, 2018
Malcolm Ritter, quoting I. Glenn Cohen (Faculty Director)

From the article: Once the genetic profile is done, could it come back to haunt a child if, say, a life insurer or nursing home demanded to see it to assess disease risk? How would the large number of rejected embryos be handled ethically and politically?

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New Article Examines the Possibility of Applying Workplace Safety Rules to the NFL

Part of the Law and Ethics Initiative of the Football Players Health Study at Harvard University, April 17, 2018
Article authored by Adam M. Finkel, Chris Deubert, Orly Lobel, I. Glenn Cohen (Faculty Director), and Holly Fernandez Lynch (Former Executive Director

Could occupational health and safety laws be applied to better protect NFL players? A new analysis, published on April 17 in the Arizona Law Review, explores this very possibility. …

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Is the ‘Breakthrough Therapy’ Process Putting Dangerous Drugs on Store Shelves?

Healthline, April 17, 2018
Shawn Radcliffe, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: A CNN report last week detailed the deaths of more than 700 patients prescribed an antipsychotic therapy drug for Parkinson’s disease. The Food and Drug Administration (FDA) continues to monitor the…

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Is FDA breakthrough therapy really valuable?

Genet, April 13, 2018
Liu Xuan Tong, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: In the recent New England Journal of Medicine, articles published by Harvard University's Jonathan Darrow, Jerry Avorn, and Aaron Kesselheim point out many of the issues arising from the "breakthrough therapies" of the US FDA and believe that…

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When ‘Breakthrough’ Drugs Aren’t Actually Breakthroughs: FDA’s Approval Pathway Can Be Misleading

Kaiser Health News, April 12, 2018
KHN Morning Briefing, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: In a review of three years of drugs approved by the Food and Drug Administration under a “breakthrough therapy” pathway, researchers argue that some of the compounds are not actually scientific breakthroughs, which they say could be potentially…

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Does the FDA’s ‘breakthrough’ drug program need to be reformed? Harvard skeptics say yes

Endpoint News, April 12, 2018
John Carroll, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: Of all the expedited review programs that the FDA has set up, none are as popular as the “breakthrough” therapy designation. And a group of high-profile skeptics says that has created some problems that need to be addressed.

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Why Scott Gottlieb is the one Trump official everybody seems to like

Vox, April 11, 2018
Julia Belluz, German Lopez, and Dylan Scott , quoting Rachel Sachs (Academic Fellow Alumna)

From the article: When Scott Gottlieb was appointed commissioner of the Food and Drug Administration last May, some were concerned he’d be a 

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House Democrat wants to know why a pharma insider is overseeing Trump’s drug pricing reform

Vox, April 9, 2018
Dylan Scott, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: House Democrats want to know why the Trump administration is letting a former pharmaceutical industry insider oversee its plans to fulfill President Donald Trump’s promises to bring down drug prices. Rep. Keith…

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Politico Pulse April 6, 2018

Politico, April 6, 2018
Dan Diamond, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: In Health Affairs, Nick Bagley and Rachel Sachs ask why Massachusetts' proposal to ostensibly lower drug prices is getting a cold shoulder from the Trump administration. Read the full article

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ICER Weekly View April 6, 2018

Institute For Clinical And Economic Review, April 6, 2018
Mitchell Stein, quoting Rachel Sachs(Academic Fellow Alumna)

From the article: To the shock of patient advocates, MA wanted to institute a drug formulary for Medicaid. Reports this week indicate that CMS is poised to deny the waiver request. Law Professors Nicholas Bagley and Rachel Sachs write in Health Affairs that the supposed…

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Massachusetts Wants To Drive Down Medicaid Drug Costs: Why Is The Administration So Nervous?

Health Affairs, April 5, 2018
Nicholas Bagley, and Rachel Sachs (Academic Fellow Alumna)

From the article: Although drug formularies are ubiquitous in Medicare and the private insurance market, they’re absent in Medicaid. By law, state Medicaid programs that offer…

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FDA-designated ‘breakthrough’ therapies may not actually be scientific breakthroughs

Stat, April 11, 2018
Ike Swetlitz, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: WASHINGTON — In a review of three years of drugs approved by the Food and Drug Administration under a “breakthrough therapy” pathway, researchers argue that some of the compounds are not actually scientific breakthroughs, which…

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US FDA’s Breakthrough Program Needs Higher Standard For Comparators, NEJM Says

Pink Sheet, April 11, 2018
Michael Cipriano, quoting Jonathan Darrow (Student Fellow Alumnus)

This article is behind a paywall. Readers will have to pay for full access to the article.  Executive Summary Harvard Medical School researchers call for inclusion of off-label drugs, accelerated approvals, and dietary supplements in the definition…

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Utah’s quixotic Medicaid expansion plan, explained

Vox, April 2, 2018
Dylan Scott, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Utah wants to expand Medicaid under the Affordable Care Act. Kind of. The state legislature has passed and Gov. Gary Herbert 

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Healthcare Accreditation Driving Patient Excellence in Europe

Medical Tourism Magazine, quoting I. Glenn Cohen (Faculty Director)

From the article: In the business of medical travel, quality drives the market and the quality of healthcare a hospital or healthcare organization provides is often validated by its accreditation status. Since the industry began expanding,…

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Surgery Lit by Cellphone: Togo Doctors Strike Over Deplorable Hospitals

The New York Times, April 7, 2018
Tim McDonnell, quoting I. Glenn Cohen (Faculty Director)

From the article: I. Glenn Cohen, a professor at Harvard Law School and an expert on health law and bioethics, said medical ethicists generally agree that the potential benefits of a doctors’ strike can justifiably outweigh the potential risk to patients, if…

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Can Lost Embryos Give Rise to a Wrongful-Death Suit?

The Atlantic , April 5, 2018
Sara Zhang, quoting I. Glenn Cohen (Faculty Director)

From the article: Over a single weekend in March, an unprecedented disaster hit fertility clinics—twice. First came the news that the University Hospitals Fertility Center in Ohio, lost more than 4,000 eggs and embryos in…

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