Should We Study Human Embryos Beyond 14 Days?

NOVA Next, April 26, 2017
Jenny Morber, quoting I. Glenn Cohen (Faculty Director)

From the article: [...] Some critics view calls to re-evaluate the 14-day rule as a pernicious moving of the goalposts. How meaningful can they be, the line of reasoning goes, if scientists want to change rules as soon as they bump up against them?

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The new Oprah movie about Henrietta Lacks reopens a big scientific debate

Vox, April 24, 2017
Julia Belluz, quoting Holly Fernandez Lynch (Executive Director)

From the article: [...] Holly Fernandez Lynch, executive director of the Petrie-Flom Center for Health Law Policy,…

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Prize fund for new antibiotics could mean true innovation

STAT News, April 25, 2017
Rachel E. Sachs (Academic Fellow Alumna)

A few weeks ago, a group of Democrats in both houses of Congress introduced the Improving Access to Affordable Prescription Drugs Act, a 129-page bill designed to lower drug prices while increasing innovation and cracking down on pharmaceutical company abuses (my thoughts on the bill are here). …

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As a competitor encroached, Mylan took one state to court to push EpiPen sales, documents

STAT News, April 24, 2017
Ike Swetlitz, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Three lawyers who reviewed the case at the request of STAT said they could not think of another instance when a pharmaceutical company sued to protect the status of its medication on a state…

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Science Needs Your Cells: New York Times Op-Ed by Executive Director Holly Fernandez Lynch

New York Times, April 21, 2017
Holly Fernandez Lynch (Executive Director) and Steven Joffe

Biospecimens are essential to medical progress, but just medical waste to patients. Let's promote the science. From the op-ed: Many aspects of Ms. Lacks’s story reflect genuine injustice: the racism that characterized the…

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PFC Spotlight: Student Fellow Alumnus Matthew Baum

Petrie-Flom Center, April 13, 2017

Matthew Baum was a Student Fellow for the 2013-2014 academic year, as a second year MD-PhD student in the Health Science and…

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Death By 1,000 Cuts: How Republicans Can Still Alter Your Coverage

Kaiser Health News, April 10, 2017
Jay Hancock, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: “It’s the single-biggest problem facing the exchanges,” said Rachel Sachs, a health law professor at Washington University in St. Louis. “That would make insurers not only exit tomorrow but also not want to offer plans in…

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Congress and FDA nominee heap love on ‘adaptive trials’

Science, April 7, 2017
Kelly Servick, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: “‘Adaptive clinical trials’ is one of those buzzwords that get brought up all the time,” says Rachel Sachs, an innovation and health law professor at Washington University in St. Louis in Missouri, and “there is definitely…

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Scott Gottlieb: Conflicts surround Trump’s FDA pick

CNN, April 4, 2017
Sandee LaMotte, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Even some industry watchdogs are cautiously optimistic. In a New England Journal of Medicine perspective, Rachel Sachs, a Washington University associate professor of law who studies the FDA, points to Gottlieb's former ties to industry…

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ICER Weekly View 03-31-17

ICER, March 31, 2017
Mitchell Stein, featuring blog post and NEJM article co-authored by Rachel E. Sachs (Academic Fellow Alumna)

From the review: Democrats’ New Drug Bill Improving Access to Affordable Prescription Drugs Act was introduced this week.  You can read the summary of the bill here.  Rachel Sachs takes a deep dive into the significance…

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Anthem inches closer to full Obamacare exit

POLITICO, March 31, 2017
Dan Diamond, featuring blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the newsletter: WHAT WE'RE READING Writing at Harvard’s “Bill of Health,” Rachel Sachs offers reasons to be bullish on Democrats’ drug price legislation but also picks apart its flaws. Read…

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Senate will vote to overturn Planned Parenthood protections

POLITICO, March 30, 2017
Dan Diamond, featuring NEJM article co-authored by Rachel E. Sachs (Academic Fellow Alumna)

From the newsletter: What the experts are saying. NEJM posted a pair of perspectives that offering dueling approaches to Gottlieb and the challenges he may face, if confirmed. — "An FDA Commissioner for the 21st Century."…

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Price doesn’t satisfy Congress on appropriations

POLITICO, March 30, 2017
Darius Tahir, featuring NEJM article co-authored by Rachel E. Sachs (Academic Fellow Alumna)

From the newsletter: The latest issue of the New England Journal of Medicine is full of eHealth-relevant papers. Two articles consider Scott Gottlieb’s nomination for FDA commissioner. One, by Harvard researcher Daniel Carpenter, argues that Gottlieb…

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Release of New FDA Guidance Declines Sharply Following Trump’s Inauguration

Regulatory Affairs , April 11, 2017
Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow Alumna)

[...] Rachel Sachs, an associate professor of law at Washington University in St. Louis, told Focus: “I think they're waiting for Gottlieb to set his priorities, and they'll move forward then. The other thing I'll say is that they've…

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Panthers doctor: ‘Turf war’ keeping neurologists off NHL study group

TSN Canada, April 7, 2017
Rick Westhead, quoting I. Glenn Cohen (Faculty Director)

From the article: One Harvard University law professor says that the NHL should overhaul its medical structure to free team doctors and trainers from any real or perceived conflicts of interest. Glenn Cohen, a Montreal native who…

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(Health) Law and Order

Beyond the Microscope Podcast, March 28, 2017
Mumu Xu, interviewing Rachel E. Sachs (Academic Fellow Alumna)

We’ve got a special episode today for all you STEM/legal nerds. Our guest is Rachel Sachs, an Associate Professor at the Washington University in St. Louis School of Law. Rachel works at the intersection of patent law and health law. Listen as we discuss EpiPens, genetic testing, and…

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An FDA Commissioner for the 21st Century

NEJM, March 29, 2017
Amitabh Chandra and Rachel E. Sachs (Academic Fellow Alumna)

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 whose names were floated publicly for the position, Gottlieb is a traditional choice, a physician who served in a deputy commissioner…

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Sanofi, Regeneron ask court to shield Dupixent from Amgen patent attack

FiercePharma, March 21, 2017
Tracy Staton, citing blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...]Amgen has caught fire for its aggressive stance on its PCSK9 patents, which also protect its own drug in the class, Repatha. Market watchers note that a similar patent fight—Merck & Co.'s hepatitis C lawsuit against Gilead Sciences—ended…

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In Pausing Human Research On Zika, Medical Ethicists Acknowledge A Dark Past

WBUR, March 21, 2017
Paul C. McLean, quoting Holly Fernandez Lynch (Executive Director)

From the article: That’s why ethics review of human subject research matters. This NIH panel is an especially good model in both its composition — expertise in law, medicine, medical science, social sciences, vaccine research and advocacy and bioethics…

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Addressing the ethical issues raised by synthetic human entities with embryo-like features

eLife, March 21, 2017
John Aach, Jeantine Lunshof, Eswar Iyer, and George M. Church

On November 7, 2016, the Petrie-Flom Center hosted the conference "The Ethics of Early Embryo Research & the Future of the 14-Day Rule," which convened experts in bioethics,…

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