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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The ethics of recruiting study participants on social media

Medical Xpress , March 16, 2017
Heather Zeiger, citing Luka Gelinas (Fellow in Clinical Research Ethics)

From the article:  In the recent issue of the American Journal of Bioethics, the target article addresses the ethics of finding participants for clinical trials on social media sites. The authors, from Harvard Law School and Harvard Medical School, analyzed the particular…

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Harvard Law School Ranked #5 for Health Care Law

U.S. News & World Report , March 2017

U.S. News & World Report has released their rankings of the top law schools in the country. Harvard Law School, ranked #3 overall, was also ranked #5 in the country for health care law!

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NFL doctors are on the wrong team

Washington Post, March 11, 2017
Editorial Board, citing Football Players Health Study

From the article: So why did only 47 of 100 players who were surveyed by the Associated Press say they thought the league’s clubs, coaches and team doctors have the athletes’ best interests at heart? Even more damning were the results of a two-year…

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NFL’s medical structure puts profits before players’ health. That must change.

Washington Post, March 9, 2017
Sally Jenkins, citing Football Players Health Study

From the article: Just last month, a Harvard study concluded that “the intersection of club doctors’ dual obligations creates significant…

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The Original Lie About Obamacare

New York Times, March 14, 2017
David Leonhardt, quoting Michael Anne Kyle (Student Fellow Alumna)

From the article: At that point, Obama faced a second choice – between forging ahead with a substantively bipartisan bill and forgetting about covering the uninsured. The kumbaya plan for which pundits now wax nostalgic was not an option.

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Podcast: NFL Player Health with Chris Deubert

Sports Law Biz Blog, March 6, 2017
Peter Ott, interviewing Christopher R. Deubert (Senior Law & Ethics Associate)

From the blog: In this episode, Peter speaks with Chris Deubert, a Senior Law and Ethics Associate for the Law and Ethics initiative of the Football Players Health Study at Harvard University. Chris has wide ranging sports law experience and combined…

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Teen Behind Landmark Juvenile Decision Back Before Judge to Be Resentenced

Juvenile Justice Information Exchange, March 13, 2017
Matt Smith, quoting Robert Kinscherff (Senior Fellow in Law and Neuroscience)

From the article: “The result of this developmental process means that adolescents will not think like or process like adults will until probably their mid-20s,” said Robert Kinscherff, a forensic scientist and attorney at the Project on Law…

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