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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Modern Death

MoMA R&D Salon, Salon 19, January 23, 2017
Frances Kamm (Senior Fellow Alumna)

The term modern has been central to MoMA’s identity since its founding, yet to be modern holds many connotations. To name just a few interpretations—not all canonical—modern can be understood as a static historical and aesthetic marker of the 20th century; a frenetic socio-cultural…

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Maryland Goes a Step Further to Rein in Drug Price Spikes

Regulatory Affairs Professionals Society (RAPS), February 27, 2017
Zachary Brennan, citing Rachel E. Sachs (Academic Fellow Alumna)

[...] The bill has drawn criticism from industry groups and others who say such independent audits would be overly burdensome for industry and that the $2500 threshold might include too many drugs as other states have included a $10,000 threshold, though other…

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Ethical Considerations for Zika Virus Human Challenge Trials: Report & Recommendations

National Institute of Allergy and Infectious Diseases (NIAID) at NIH and the Walter Reed Army Institute of Research (WRAIR), February 2017
Seema K. Shah, Jonathan Kimmelman, Anne Drapkin Lyerly, Holly Fernandez Lynch (Executive Director), et al.

From the report: Zika virus is an emerging infectious disease that was first identified in 1947, and that has more recently become a major public health threat around the world. Zika virus has recently been shown to cause devastating neurological damage in infants…

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Lawmakers urge US Army not to issue exclusive license to Sanofi for a Zika vaccine

Stat, February 22, 2017
Ed Silverman, quoting Rachel E. Sachs (Academic Fellow Alumna)

This article is behind a paywall.

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Express Scripts CEO addresses drug pricing ‘misinformation’

St. Louis Post-Dispatch, February 17, 2017
Samantha Liss, quoting Rachel E. Sachs (Academic Fellow Alumna)

[...] Typically, after dispensing drugs to patients, a drug manufacturer will write Express Scripts a rebate check. That timing can expose some patients, especially those with high deductibles, to the full cost of a drug, said Rachel Sachs, an associate professor of law at Washington University.…

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Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations

The American Journal of Bioethics, Volume 17, 2017 - Issue 3
Luke Gelinas, Robin Pierce, Sabune Winkler, I. Glenn Cohen, Holly Fernandez Lynch, and Barbara Bierer

Part of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical…

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Why Did That Drug Price Increase 6,000%? It’s The Law

Forbes, February 10, 2017
Matthew Herper, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Marathon is a member of the Pharmaceutical Research and Manufacturers of America (PhRMA), the drug industry trade group. Drug companies cannot use their usual argument of saying this is an “outlier.” This is one of their own – although…

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Trump’s ‘Two Out, One In’ Regulatory Policy May Apply to Some FDA Guidance

Regulatory Affairs Professionals Society (RAPS), February 6, 2017
Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: As far as what existing regulations if repealed would be considered part of the “two out” part of the EO, OMB notes, “Any existing regulatory action that imposes costs and the repeal or revision of which will produce verifiable…

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E&C delays vote on drug pricing bill

Politico, February 6, 2017
Sarah Karlin-Smith, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: On cost: studies have found that it usually takes a handful of generic drugscompeting for market share for prices to drop. “You usually need to get to something like three or four generics to really make a difference,” said Rachel Sachs…

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What You Don’t Know About the Cost of Grandma’s Prescription

Pacific Standard, February 3, 2017
Carson Leigh Brown, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: To grapple with how and why the process works this way, we talked with Rachel Sachs, an associate professor of law at Washington University in St. Louis. Sachs studies how health and intellectual property laws affect food and drug regulation…

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NFL Team Doctors: In Whose Interest?

Radio Health Journal, February 5, 2017
Nancy Benson, interviewing I. Glenn Cohen (Faculty Director)

From the interview: Injured NFL players are treated by doctors employed by teams, but a Harvard study claims there is an inherent conflict of interest in that arrangement, which might mean putting players on the field before they’re recovered. One of the study’s…

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A New Day For Oversight Of Human Subjects Research

HealthAffairs, February 6, 2017
Holly Fernandez Lynch (Executive Director)

Editor’s note: This post is part of a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23rd,…

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What Experts in Law and Medicine Have to Say About the Cost of Drugs

The Health Care Blog, February 2, 2017
Andy Oram, on PFC's 5th Annual Health Law Year in P/Review Conference

From the article; Pharmaceutical drug costs impinge heavily on consumers’ consciousness, often on a monthly basis, and have become such a stress on the public that they came up repeatedly among both major parties…

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The Trump-era Supreme Court could erode abortion access with a ‘death by 1,000 cuts’

Business Insider, February 1, 2017
Rebecca Harrington, quoting I. Glenn Cohen (Faculty Director)

From the article: Glenn Cohen, a health-law expert and professor at Harvard Law School, said two kinds of laws provide the most likely paths for SCOTUS to overturn or undermine Roe. The first are known as fetal-pain laws. They…

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Trump’s travel ban rattles medical residency programs

Politico Pulse, January 31, 2017
Dan Diamond, featuring blog post by Rachel Sachs (Academic Fellow alumna)

From the article: Trump's order on regulations is a 'terrible idea' for rulemaking. That's according to law professor Rachel Sachs, who uses the 21st Century Cures Act — which passed Congress with bipartisan support — as an example…

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Morning View 01-31-17

Institute for Clinical and Economic Review (ICER), January 31, 2017
Mitchell Stein, featuring blog post by Rachel Sachs (Academic Fellow alumna)

From the article: The President issued an Executive Order basically saying that for every new regulation, two old regulations must be eliminated.  This order will have a significant impact on the FDA.  Two articles below, first a general account, then a…

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Vitals

Axios, January 31, 2017
David Nather, featuring blog post by Rachel Sachs (Academic Fellow alumna)

From the article: The executive order could have an especially big impact on implementing the 21st Century Cures law, which just passed in the last Congress. Rachel Sachs, a health care legal expert at Washington University in St. Louis, explains why in this…

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The $4,500 injection to stop heroin overdoses

Washington Post, January 27, 2017
Shefali Luthra, quoting W. Nicholson Price II (Academic Fellow Alumnus)

From the article: Thanks to an infusion of public funding to combat opioid overdoses, other institutional buyers may also be able to afford Evzios. Their budgets are larger right now, so they’re less price sensitive, said Nicholson Price, an assistant professor…

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