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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Most-Cited Health Law Scholars in Web of Science, 2013-2017

By I. Glenn Cohen, Mark A. Hall, David M. Studdert

This is a companion post to Most-Cited Health Law Scholars in WestLaw, 2013-2017. As noted there, health law is a broad and fundamentally interdisciplinary field that spans bioethics, biotechnology, medical malpractice, health care finance and regulation, health policy, and public health.  The Westlaw citation search partially accounted for this breadth by including leading health law scholars in schools of public health and medicine.  However, two major limitations remain—both especially important in our field—which prompted this additional citation analysis.

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Challenges for Journals—Encouraging Sound Science

This post is part of a series on emerging research challenges and solutions. The introduction to the series is available here, and all posts in the series are available here.

By Barbara A. Spellman, Professor of Law and Professor of Psychology, University of Virginia School of Law

Journals and scientists should be BFFs. But currently they are frenemies. Or, in adult-speak:

Journals play an important role in ensuring that the scientific enterprise is sound. Their most obvious function is to publish science—good science, science that has been peer-reviewed by experts and is of interest to a journal’s readership. But in fulfilling that mission, journals may provide incentives to scientists that undermine the quality of published science and distort the scientific record.

Journal policies certainly contributed to the replication crisis. As businesses, publishers (appropriately) want to make money; to do so they need people to buy, read, and cite their journals. To make that happen, editors seek articles that are novel, that confirm some new hypothesis, and that have clear results. Scientists know that editors want articles with these qualities. Accordingly, scientists may (knowingly or not) bias the scientific process to produce that type of result.

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TODAY, 11/6 at 5 PM: Health Law Workshop with David Studdert

November 6, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “Once Ticketed, Twice Shy? Specific Deterrence from Road Traffic Laws”

David M. Studdert is Professor of Medicine and Professor of Law at Stanford University. He is a leading expert in the fields of health law and empirical legal research. His scholarship explores how the legal system influences the health and well-being of populations. A prolific scholar, he has authored more than 150 articles and book chapters, and his work appears frequently in leading international medical, law, and health policy publications.

Before joining the Stanford faculty, Studdert was on the faculty at the University of Melbourne (2007-13) and the Harvard School of Public Health (2000-06). He has also worked as a policy analyst at the RAND Corporation, a policy advisor to the Minister for Health in Australia, and a practicing attorney.

Studdert has received the Alice S. Hersh New Investigator Award from AcademyHealth, the leading organization for health services and health policy research in the United States. He was awarded a Federation Fellowship (2006) and a Laureate Fellowship (2011) by the Australian Research Council. He holds a law degree from University of Melbourne and a doctoral degree in health policy and public health from the Harvard School of Public Health.