Picture of doctor neck down using an ipad with digital health graphics superimposed

Symposium Introduction: Ethical, Legal, and Social Implications of Deep Phenotyping

This post is the introduction to our Ethical, Legal, and Social Implications of Deep Phenotyping symposium. All contributions to the symposium will be available here.

By Francis X. Shen

This digital symposium explores the ethical, legal, and social implications of advances in deep phenotyping in psychiatry research.

Deep phenotyping in psychiatric research and practice is a term used to describe the collection and analysis of multiple streams of behavioral and biological data, some of this data collected around the clock, to identify and intervene in critical health events.

By combining 24/7 data — on location, movement, email and text communications, and social media — with brain scans, genetics/genomics, neuropsychological batteries, and clinical interviews, researchers will have an unprecedented amount of objective, individual-level data. Analyzing this data with ever-evolving artificial intelligence (AI) offers the possibility of intervening early with precision and could even prevent the most critical sentinel events.

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Close up of a mosquito sucking blood on human skin. This mosquito is a carrier of Malaria, Encephalitis, Dengue and Zika virus.

Responsibly Developing Gene Drives: The GeneConvene Global Collaborative

By James Toomey

Researchers believe that gene drives could eliminate vector-borne diseases such as malaria, by modifying mosquito species or eradicating those that carry disease, kill off invasive species, and combat the growing problem of pesticide resistance.

A gene drive is a technique for genetically modifying entire species of wild organisms. Genetically modified individuals of the species are released into the wild, so as to raise the probability that a particular gene will be passed onto the species’ progeny via reproduction.

Over the course of many generations, the gene — even if detrimental — can spread to an entire population.

But as of now, this is all hypothetical. No gene drive has been tested in the wild, and many people are skeptical that they should ever be used.

The GeneConvene Global Collaborative, a project of the Foundation for the National Institutes of Health, was started this past July to promote the responsible development and regulation of gene drive technologies. It brings together researchers, regulators and stakeholders around the world to develop best practices for gene drive research and implementation.

Because of my prior writing on this topic, I participated in GeneConvene’s fall webinar series and spoke with scientists there about the project. Read More

Stacks of books against a burgundy wall

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

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, 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.

Below are the citations for papers identified from the month of November. The selections feature topics ranging from an analysis of Medicare Part D spending on inhalers from 2012 to 2018, to an overview of vaccine development and regulations to better understand how COVID-19 vaccines will be evaluated, to an analysis of the ethical implications of emergency authorization of COVID-19 drugs for patient care. A full posting of abstracts/summaries of these articles may be found on our website.

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a pill in place of a model globe

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

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, 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.

Below are the citations for papers identified from the month of August. The selections feature topics ranging from a commentary on the need for rigorous scientific evaluation of COVID-19 vaccine candidates in the face of political and economic pressures, to an evaluation of patients’ and pharmacists’ experiences with pill appearance changes, to an examination of the extent and cost of potentially inappropriate prescription drug prescriptions for older adults. A full posting of abstracts/summaries of these articles may be found on our website.

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Empty classroom.

Who’s to Blame for COVID-19 Outbreaks at Colleges and Universities?

By Sravya Chary

For many U.S. colleges and universities that opted for in-person instruction this fall, the return to campus during the COVID-19 pandemic has proven disastrous, and prompted the question: who’s to blame for these new outbreaks?

Although administrators are quick to blame student behavior, in this post, I will argue that the administrations are ultimately at fault – their negligence has put students’ health at risk and exacerbated the public health catastrophe.

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Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

To Cut Prescription Drug Spending, Stop Delays for Generic Competition

By Beatrice Brown and Benjamin Rome

Prescription drug spending in the U.S. remains high and continues to rise, accounting for about 20% of national health expenditures. While generic competition is crucial for reducing drug prices, brand-name drug manufacturers can utilize several strategies to delay such competition by increasing the length of market exclusivity for their drugs.

Although brand-name drugs only account for 18% of all prescriptions filled, they comprise 78% of total drug spending. By contrast, equally-effective, interchangeable generic drugs can offer discounts of up to 80% off their brand-name drug counterparts.

Generic competitors can only be introduced after brand-name drugs have completed their period of market exclusivity, which typically lasts 12-16 years and is largely determined by the patents covering the drug. Brand-name pharmaceutical manufacturers have strong financial incentives to prolong this market exclusivity period and delay entry of generic products.

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Polar chart depicting state conscience protection laws for abortion (46 states), sterilization (17 states), contraception (16 states), or emergency contraception (5 states).

New Dataset: Conscience Protections for Providers and Patients

Scholarship and public debate about law’s role in protecting health care providers’ conscience rights often focus on who should be protected, what actions should be protected, and when and whether there should be any limitations on conscience rights.

But the how of these legal protections is rarely addressed – that is, when health care providers decline to participate in medical services that violate their deeply-held beliefs, exactly what consequences do state laws protect them from? The new dataset I’ve just released on LawAtlas answers this question in the context of reproductive health conscience laws, and reveals some surprising trends.

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Health Law Scholar Citation Rankings: A Better Picture This Year

By Scott Burris

Glenn and Mark have done their bit for benchmarking our field with another round of health law professor rankings. It is a largely thankless task, so thank you professors.  Last year, I responded to their list with the observation that any count based on law review publication alone was problematic in assessing the contributions of those in our field whose scholarship is primarily empirical or aimed at the health world.  I offered a suggestive “top scholars list” based on Google Scholar profiles.  Using Google Scholar, which captures articles in all fields, plus books and gray literature, brought a number of different names into the top 20.  Since Google Scholar depends on individuals to create and clean their profiles, my list missed a lot of top scholars without profiles (I am talking about you, Michelle Mello and George Annas,  etc. etc.), but it was enough to suggest that some very productive and much-cited scholars were missed in the Hall-Cohen list.

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Most-Cited Health Law Scholars in WestLaw, 2013-2017

By Mark A. Hall and I. Glenn Cohen

This post updates the ranking of health law scholars we posted last year (using 2010-2014 data), based on the latest law faculty citation analysis done by Greg Sisk (which covers 2013-2017). As before, we are following the steps Brian Leiter uses to compile “most-cited” rankings of tenured law faculty in a number of other subject areas.

Health law (as many people conceive it) is a broad field that includes bioethics, biotechnology, medical malpractice, health care finance and regulation, health policy, and public health.  Therefore, to supplement the Sisk data, we include health law scholars beyond those based at law schools.

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