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New TWIHL: Ethical Issues in Development of a COVID-19 Vaccine

This episode is the first of a series of shows dealing with health care and research ethics related to COVID-19.

Here, Tara Sklar from The University of Arizona James E. Rogers College of Law introduces Arthur Caplan, the Drs. William F. and Virginia Connolly Mitty Professor, Founding Head of the Division of Medical Ethics, and Co-Chair of the Working Group on Compassionate Use and Preapproval Access (CUPA) at NYU Grossman School of Medicine. Dr. Caplan discusses ethical issues in development of a COVID-19 vaccine.

The series is co-sponsored by the NYU Grossman School of Medicine Division of Medical Ethics and the University of Arizona Health Law and Policy Program.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

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 me on Twitter @nicolasterry or @WeekInHealthLaw.

Journal of Law and the Biosciences Continues to Have an Impact

The COVID-19 pandemic has underscored the importance of the biosciences in our world, as well as the legal, ethical, and regulatory choices that shape the development and implementation of innovations from the biosciences.

The Journal of Law and the Biosciences (JLB) offers high-quality, open-access scholarship at the intersection of the biosciences and law as the first fully open-access, peer-reviewed, legal journal to focus on these issues.

Recently, the Journal of Law and the Biosciences received an updated impact factor of 2.275, highlighting its relevance and influence in law, medicine, and ethics. JLB ranks 25th out of 154 law journals, second of sixteen legal medicine journals, and third out of sixteen medical ethics journals.

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hospital equipment

Taking Control During COVID-19 Through Advance Care Planning

By Stephanie Anderson and Carole Montgomery

A deep divide exists in the American health care system between patients’ values and the care they receive.

Let’s start with a story – Marcus was in his mid-40’s when he underwent high-risk heart surgery during which he suffered a brain injury. Afterward, the surgeons at first reassured his family that the surgery itself was successful (his heart was working fine) in spite of his brain injury.

Unfortunately, after many days in the ICU he remained unconscious and was not able to get off the ventilator. Specialists told the family that his brain injury was severe, and he would likely not be able to carry on a meaningful conversation or live independently ever again.

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TWIHL 212: Substance Use Privacy Before and After CARES

By Nicolas Terry

In this episode, I welcome back Kirk Nahra, a partner and Co-Chair of the Cybersecurity and Privacy Practice at Wilmer Hale in DC. He has been a leading authority on privacy and cybersecurity matters for more than two decades. Mr. Nahra counsels clients across industries, from Fortune 500 companies to startups, on implementing the requirements of privacy and data security laws across the country and internationally.

And, after all this time, finally I welcome Melissa Goldstein, Associate Professor in the Department of Health Policy and Management at the Milken Institute School of Public Health at the George Washington University, where she teaches courses in bioethics (including genomics, reproductive ethics, end-of-life, and research ethics issues), health information technology policy, and public health law and conducts research on health information privacy and the legal and policy aspects of health information technology. Our excuse for getting together is that we recently co-authored a piece on the Health Affairs blog titled COVID-19: Substance Use Disorder, Privacy, And The CARES Act.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

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 me on Twitter @nicolasterry or @WeekInHealthLaw.

a crowd of people shuffling through a sidewalk

The SSTAR Initiative: A Policy Proposal for a Full, Equitable Recovery from COVID-19

By Sara E. Abiola and Zohn Rosen

Full recovery from the COVID-19 pandemic in the U.S. will require new policy that promotes equity and streamlines access to social services while supporting small businesses

Unprecedented job loss due to COVID-19 has led to an economic crisis for families of all backgrounds and income levels.

Current health and social services programs are ill-equipped to handle this need. Moreover, long-standing racial health inequities and the stigma associated with using social services will persist in the absence of significant systems-level change.

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A male pharmacist is examining a drug from a pharmacy inventory.

How Policies Enacted During COVID-19 Might Reduce Future Drug Spending

By Beatrice Brown

The COVID-19 pandemic has prompted several states to take steps to temporarily authorize therapeutic substitution of drugs experiencing sudden shortages, whether due to spikes in demand or supply chain disruptions.

Although these instances of replacing patients’ typical prescription drugs with different drugs intended to have the same therapeutic effects have been prompted by necessity, therapeutic substitution more generally might reduce drug spending in the United States.

In a recent piece in the BMJ, Jonathan Darrow, Jessica Chong, and Aaron Kesselheim explore using state laws to expand the authority of pharmacists to substitute clinically similar alternatives in order to help cut spending. Actions taken by states to temporarily allow therapeutic substitution can help them gain experience with this strategy and potentially lead to broader and more permanent drug substitution policies that could help decrease drug spending.

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Task force on coronavirus and equity report card.

The Health Equity Failures of Massachusetts’ COVID-19 Reopening Plan

By Charlene Galarneau

Massachusetts began Phase III of its reopening plan this week. Reopening unquestionably involves disproportionate risks to the health of some residents relative to others, and the State’s push forward fails to adequately address these risks.

Phase III of Governor Baker’s Reopening Massachusetts Plan began on July 6, with the exception of Boston, which will begin Phase III on July 13. The first step of Phase III focuses on the reopening of recreational activities: gyms, movie theaters, museums, casinos, and professional sports teams, with specific rules for each type of operation.

In its May 2020 report, “Reopening Massachusetts,” the State’s Reopening Advisory Board asserts that “key public health metrics will determine if and when it is appropriate to proceed through reopening phases.” It references six indicators, including the COVID-19 positive test rate, deaths, hospitalizations, health care system readiness, testing capacity, and contact tracing capabilities.

But these state-wide metrics are inadequate, in both public health and ethics terms. Missing from these metrics in particular, and this Reopening Plan in general, is recognition of, not to mention accountability for, the predictably disproportionate negative impacts that reopening has on the lives of Black and Latinx residents, low-wage workers, and other groups already disparately harmed by COVID-19.

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Return to work graphic.

A Conversation on Safeguarding Employee Health During COVID-19

By Sarah Rispin Sedlak

On July 9th, as part of an ongoing “Coronavirus Conversations” series hosted by the Duke University Initiative for Science and Society, three experts will gather to discuss how the novel coronavirus spreads in the workplace, the steps employers can and should be taking to provide for employee safety in light of that, and how to do so while respecting employee concerns about personal safety, privacy and autonomy.

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Busy Nurse's Station In Modern Hospital

A Physician Reflects on COVID-19 and Advance Care Planning

By Shoshana Ungerleider

It was the end of a 24 hour shift in the ICU when the 85-year-old woman I had just admitted with end stage heart failure began having trouble breathing. While I knew she did not desire “aggressive measures” taken to prolong her life, I wondered what that meant in the context of this moment. Even though I was a young medical resident, I knew without swift intervention, she would not be able to survive the night. I ran into the waiting room to search for her son, her medical decision maker, but he had gone home for the night.

I returned to the bedside to see that my patient was tiring as her breathing was becoming shallow and fast. She was awake and I sat down to explain why she was feeling breathless. I explained that her condition had rapidly worsened and asked if she had ever considered a scenario where she may need a breathing tube. She had not. As her oxygen levels dropped, it quickly became clear that we had to act. What wasn’t clear to me was whether this frail woman would actually survive this hospital stay, and if she truly understood what intubation and mechanical ventilation were and whether this would cause her to suffer.

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empty hospital bed

The COVID-19 Pandemic Highlights the Necessity of Advance Care Planning

By Marian Grant

The COVID-19 pandemic has laid bare the importance of clearly expressing personal wishes for medical care in emergency situations.

Health systems and providers across the country are seeing how important it is that all of us discuss our medical goals in advance. Not having one’s medical goals known in advance puts a burden on frontline clinicians and loved ones, because it leaves important medical decisions up to them.

You can and should speak up about the kind of medical care you would want, and tell doctors what matters to you. You also should tell those who matter most to you what you’d want if you couldn’t make decisions for yourself.

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