Month: April 2017

Housing Equity Week in Review

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Lots of news from the past week in housing equity and law. Check out the latest in the field from the week of April 10-17, 2017:

  • In his first television interview as Secretary of Housing and Urban Development, Ben Carson talked about the rich’s obligation to help the poor and the importance of private sector involvement in planning of housing policy. Coverage from NY Times.
  • Ben Carson’s listening tour arrived in Miami, where he then got stuck in an elevator at a public housing complex. Some advocates hope that this will be a live example of the need for more funds to maintain these facilities, via CBSNews.com
  • Chronic nuisance ordinances continue to be a driver for eviction, but do they have a disparate impact against victims of domestic abuse? Via the NY Times.
  • Baltimore is taking a new approach to neighborhood revitalization. Can it be done without gentrification? Via the Nation.
  • The Atlantic’s CityLab published a New Urban Crisis Index map!

TODAY, 4/17 at 5 PM! Health Law Workshop with Judith Daar

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April 17, 2017, 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “A Clash at the Petri Dish: Transferring Embryos with Known Genetic Anomalies”

Judith Daar is Professor of Law at Whittier Law School with a joint appointment at the UCI School of Medicine. She focuses her teaching and scholarship at the intersection of law, medicine and ethics. Her interdisciplinary work in law and medicine focuses in the area of reproductive medicine, where she holds leadership positions including Chair of the American Society for Reproductive Medicine Ethics Committee. In 2005, Professor Daar became Chair of the Association of American Law School’s Section on Law, Medicine and Health Care, and in 2006 she was named to the Board of Directors of the American Society of Law, Medicine & Ethics. She was elected President of ASLME in 2009 and re-elected for a second term in 2010. In 2007, she was appointed to the Society for Assisted Reproductive Technologies, Committee on Informed Consent in ART, an interdisciplinary group of physicians and attorneys charged with drafting a model informed consent document for patients undergoing in vitro fertilization. From 2008 to 2012, Professor Daar served as Associate Dean for Academic Affairs. In 2012, she was elected to the American Law Institute.

Professor Daar is a member of the UCI Medical Center Medical Ethics Committee, where she serves on the Bioethics Consultation Team. She has also served as a member of the Harbor-UCLA Hospital Institutional Review Board, and the ABACoordinating Group on Bioethics. Professor Daar has lectured extensively in the field of reproductive medicine, including giving testimony to the California legislature and the National Academies of Science, Committee on Science, Technology, and Law on the issue of oversight and regulation of reproductive medicine. Her scholarship focuses in the area of assisted reproductive technologies where she has authored over one hundred articles, book chapters, editorials and white papers on topics including stem cell research, human cloning, frozen embryo disputes, the use of genetic technologies and the regulation of reproductive medicine. Her first book, Reproductive Technologies and the Law, was published in January 2006, with a second edition appearing in 2013. Her most recent book, The New Eugenics: Selective Breeding in an Era of Reproductive Technologies, will be published by Yale University Press.

TOMORROW (4/18)! Healing in the Wake of Community Violence: Lessons from Newtown and Beyond – Panel discussion and screening of the documentary Newtown (2016)

The Petrie-Flom Center Staff 1 Comment

NEW EVENT: Healing in the Wake of Community Violence: Lessons from Newtown and Beyond imageHealing in the Wake of Community Violence: Lessons from Newtown and Beyond: Panel discussion and screening of the documentary Newtown (2016)

April 18, 2017 4:00pm screening; 5:30pm panel discussion

Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
Register for this event

This event is free and open to the public, but seating is limited and registration is required. Register here.

Join us for a film screening and panel discussion on challenges that arise from tragic acts of community violence. The event will begin with a screening of Newtown, a documentary examining the impact of the mass shooting at the Sandy Hook Elementary School in December 2012. The screening will be followed by a panel of experts in health law policy, the neurobiology of trauma, and community approaches to violence in a discussion of public health, gun violence, and responses to community trauma. Discussion will highlight the issue of “healing the helpers”—the first responders, medical staff, clergy, mental health providers, and others who respond to the needs of victims, families, and communities in the wake of community violence.

Welcome

  • Martha Minow, Morgan and Helen Chu Dean and Professor of Law, Harvard Law School

Panelists

  • Michelle Bosquet Enlow, Assistant Professor of Psychology, Harvard Medical School and Associate in Psychology, Boston Children’s Hospital
  • Rufus J. Faulk, Program Director, Gang Mediation Initiative, Boston TenPoint Coalition
  • Wendy Parmet, Matthews Distinguished University Professor of Law, Director of the Center for Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support, Northeastern University School of Law; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs
  • Moderator: Ahmed Ragab, Richard T. Watson Associate Professor of Science and Religion and Director, Science, Religion, and Culture Program, Harvard Divinity School

This event is free and open to the public, but seating is limited and registration is required. Register here.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Cosponsored by William James College and the Science, Religion, and Culture Program at Harvard Divinity School.

Sanctuary Cities & NFIB v. Sebelius

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By Kevin Outterson 

Ironic that the leading argument against the President’s Executive Order 13768 on Sanctuary Cities is none other than the states’ rights / coercion arguments that convinced seven Justices to make the Medicaid expansion voluntary.  Backstory on this element of National Federation of Independent Business (NFIB) v. Sebelius from 2012 here, with the abstract below:

Of the four discrete questions before the Court in National Federation of Independent Business v. Sebelius, the Medicaid expansion held the greatest potential for destabilization from both a statutory and a constitutional perspective. As authors of an amicus brief supporting the Medicaid expansion, and scholars with expertise in health law who have been cited by the Court, we show in this article why NFIB is likely to fulfill that promise.

For the first time in its history, the Court held federal legislation based upon the spending power to be unconstitutionally coercive. Chief Justice Roberts’ plurality (joined for future voting purposes by the joint dissent) decided that the Medicaid expansion created by the ACA was a “new” program to which Congress could not attach the penalty of losing all Medicaid funding for refusing to participate. NFIB signals the Roberts Court’s interest in continuing the Federalism Revolution. The Court relied on, seemingly modified, and strengthened at least two existing elements of the test for conditional spending articulated in South Dakota v. Dole. Clear notice and germaneness now appear to be folded into the newly fashioned yet undefined coercion doctrine, which relied on quantitative as well as qualitative analysis to determine that the Medicaid expansion was unconstitutionally coercive. The Court is now actively enforcing the Tenth Amendment to protect states from federal spending legislation. Read More

Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of March. The selections feature topics ranging from a warning about shortcuts in drug development, to the association between direct-to-consumer advertising and testosterone testing and initiation in the United States, to the origins of and solutions to the high price of anticancer drugs. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bouvy JC, Blake K, Slattery J, De Bruin ML, Arlett P, Kurz X. Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013. Pharmacoepidemiol Drug Saf. 2017 Mar 26. [Epub ahead of print]
  2. Califf RM. Warning About Shortcuts in Drug Development. J Am Heart Assoc. 2017 Mar 21;6(3). pii: e005737.
  3. Hey SP, Kesselheim AS. Reprioritizing Research Activity for the Post-Antibiotic Era: Ethical, Legal, and Social Considerations. Hastings Cent Rep. 2017;47(2):16-20.
  4. Layton JB, Kim Y, Alexander GC, Emery SL. Association Between Direct-to-Consumer Advertising and Testosterone Testing and Initiation in the United States, 2009-2013. JAMA 2017;317(11):1159-1166.
  5. Luo J, Kesselheim AS, Avorn J. Medicaid Expenditures and Estimated Rebates for Epinephrine Autoinjectors, 2012 to 2016. JAMA Intern Med. 2017 Mar 27. [Epub ahead of print]
  6. Prasad V, Jesús K, Mailankody S. The high price of anticancer drugs: origins, implications, barriers, solutions. Nat Rev Clin Oncol. 2017 Mar 14. [Epub ahead of print]

Jelly Beans, Booze, and B-Vitamins

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By Seán Finan

The FDA’s policy guidelines on nutritional fortification include the so-called “jelly-bean rule:” the FDA considers it inappropriate to fortify candy or soda with nutrients because to do so would allow “misleading health claims” to be made about a putatively unhealthy product. Candy companies that tried to add vitamins their products to market them as “healthier” have already been targeted by the FDA. But take a quick glance at the shelves of any convenience store: the “healthy”, vitamin enriched snacks and drinks are so full of sugars, flavors and sweeteners that it would take a doctorate in metaphysics, rather than medicine, to distinguish them from the candy and soda. So, maybe the FDA’s stance on adding a spoonful of sugar to help the medicine go down has relaxed. With that in mind, here’s a little thought experiment. I’d like to bring a proposal back from the eighties: that inexpensive alcoholic beverages be fortified with allithiamine, a fat-soluble analogue of Vitamin B1.[1] Why? The fortification could dramatically reduce the incidence of Wernicke’s encephalopathy and Korsakoff’s Syndrome among the homeless and alcoholic population.

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Heather Howard on ‘The Week in Health Law’ Podcast

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By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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Health policy researcher Heather H. Howard returns to the pod and, not surprisingly, Medicaid was the focus of our talk. Howard is a lecturer at Princeton University’s Woodrow Wilson School, where she teaches courses on implementation of the Affordable Care Act (ACA), the social determinants of health, and state and local health policy. She works with states implementing health reforms and served as New Jersey’s Commissioner of Health and Senior Services from 2008-2010. She tweets at @HeatherHHoward.

We discussed various Medicaid issues; the extent non-expansion was driven by policy or politics, work requirements under Section 1115 waivers, state administrative costs associated with draconian Medicaid expansion criteria (particularly when compared to the macroeconomic effects of a robust healthcare system), cost-sharing and the “private option” in existing state plans, and the likelihood of Section 1332 waivers moving states to universal care or, at least, meaningful innovation.

Our lightning round addressed various issues, including an Altarum study on the macroeconomic effects of the ACA, and state AG’s actions regarding mHealth apps and privacy.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

DTC Genetic Risk Reports Back on Market

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By Kayte Spector-Bagdady, JD, MBE & Michele Gornick, PhD, MA

On Thursday, April 6th, the FDA announced that it will allow the direct-to-consumer (DTC) genetic testing company 23andMe to market “Genetic Health Risk” (GHR) tests for 10 diseases or conditions including early-onset Alzheimer’s and Parkinson’s Diseases. This is in addition to 23andMe’s current offering of ancestry, wellness (e.g., lactose intolerance), trait (e.g., hair color), and autosomal recessive carrier screening (e.g., sickle cell anemia) test reports.

The decade since 23andMe entered the market has been a regulatory labyrinth of twists and turns. But what direction are we headed now?

The way we were

23andMe was a pioneer of the field, entering the DTC genetics market in 2007 with a product offering 13 health-related reports for $999. By December 2013, it was offering more than 250 reports; including carrier status, drug response, and over 100 GHRs. In response to a set of FDA Untitled Letters that went out in 2010, 23andMe filed for de novo 510(K) premarket clearance for some tests… but also concurrently marketed them in a national television and web campaign. Read More

TODAY, 4/10 at 5 PM! Health Law Workshop with Leo Beletsky

Jennifer Minnich 1 Comment

April 10, 2017, 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the presentation: “America’s Favorite Antidote: Murder-By-Overdose in the Age of the Opioid Epidemic”

Leo Beletsky is Associate Professor of Law and Health Sciences with a joint appointment with the School of Law and Bouvé College of Health Sciences at Northeastern University. His expertise is on the use of law to advance public health. He utilizes empirical and theoretical approaches to analyze how legal mechanisms can help curb substance abuse, prevent the spread of HIV and other infectious diseases, and improve patient care. By highlighting discrepancies between black letter law and its real-world implementation, he also examines the relationship between police practices, public health outcomes, and human rights of vulnerable groups. Professor Beletsky communicates this work to legal, scientific and mainstream audiences, including as a contributor to The Huffington Post.

Throughout his career, Beletsky has applied his skills and expertise in service to governmental agencies and non-governmental organizations, including UNAIDS, US Department of Justice, the City of New York and the Open Society Foundations. This involvement has focused on legal reform and programmatic efforts to better align law and policing with community health. His commitment to translating lessons learned between domestic and international settings has informed a portfolio of projects across the Americas (US and Mexico), Central and East Asia (China, Kyrgyzstan, and Tajikistan) and Eastern Europe (Russia and Ukraine).

Prior to joining the Northeastern community, Professor Beletsky was on the faculty of the Division of Global Public Health at the University of California, San Diego School of Medicine, where he retains an adjunct appointment. He received his undergraduate training in geography from Vassar College and Oxford University, a master’s in public health from Brown University, his law degree from Temple University School of Law, and his post-doctoral training at the Yale University Center for Interdisciplinary Research on AIDS. He is a member of the New York State Bar.

Negligent Failure to Prevent Suicide in the Age of Facebook Live

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By Shailin Thomas

In 2016, Facebook unveiled a new tool that allows users to post live streams of video directly from their phones to the social media platform. This feature — known as “Facebook Live” — allows friends and followers to watch a user’s videos  as she films them. Originally conceptualized as a means of sharing experiences like concerts or vacations in real time, the platform was quickly adopted for uses Facebook likely didn’t see coming. In 2016, Lavish Reynolds used Facebook Live to document the killing of her boyfriend, Philando Castile, by the Minneapolis police, sparking a national debate surrounding police brutality and racial disparities in law enforcement. Recently, another use for Facebook Live has arisen — one that Facebook neither foresaw nor wants: people have been using Facebook Live as a means of broadcasting their suicides.

This tragic adaptation of the Facebook Live feature has put Facebook in a tough spot. It wants to prevent the suicides its platform is being used to document — and just a few weeks ago it rolled out real-time tools viewers of Live videos can use to identify and reach out to possible suicide victims while they’re filming — but it’s often too late by the time the video feed is live. Accordingly, Facebook is focusing its efforts at identifying those at risk of suicide before the situation becomes emergent. It currently has teams designing artificial intelligence algorithms for identifying users who may be at risk for suicide. These tools would scan Facebook users’ content, flagging individuals that have warning signs of self-harm or suicide in their posts.

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