Person typing on computer.

COVID-19 and the New Reproductive Justice Movement

By Mary Ziegler

The COVID-19 pandemic has transformed advocacy for reproductive rights and reproductive justice in what previously had been called an endless, unchanging, and intractable abortion conflict.

The pandemic — and the stay-at-home orders it required — finally shifted the movement’s focus to abortion access, rather than abortion rights, as exemplified by its emphasis on medication and telehealth abortion.

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Herndon, USA - April 27, 2020: Virginia Fairfax County building exterior sign entrance to Mom's Organic Market store with request to wear face mask due to covid-19 pandemic.

The Current COVID-19 Surge, Eugenics, and Health-Based Discrimination

By Jacqueline Fox

COVID has shown us that the burdens and inequities that characterize everyday life for many Americans are not merely vestiges of an older time, but an honest reflection of our unwillingness to treat everyone with dignity and respect.

We have undergone an ethical stress test in the last 18 months. While many people have exhibited heroic commitments to their fellow citizens, much of our governmental response is indefensible in a society that professes to care for all of its members. This implies we are not such a society.

Rather, we are a society riddled with healthism — discrimination based on health status — and eugenics — a pseudo-science that arbitrarily elevates some human traits over others, much as we do with breeding dogs and horses.

As a result, although we are armed with the power to prevent much harm, we lack the will or inclination to use that power for our most vulnerable. Instead, we place different values on people’s lives using arbitrary definitions of quality, and treat people differently based on their health status. Examples include placing a lower value on a life because a person is older, disabled, or overweight.

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Person receiving vaccine.

Why Do Differences in Clinical Trial Design Make It Hard to Compare COVID-19 Vaccines?

Cross-posted from Written Description, where it originally appeared on June 30, 2021. 

By Lisa Larrimore OuelletteNicholson PriceRachel Sachs, and Jacob S. Sherkow

The number of COVID-19 vaccines is growing, with 18 vaccines in use around the world and many others in development. The global vaccination campaign is slowly progressing, with over 3 billion doses administered, although the percentage of doses administered in low-income countries remains at only 0.3%. But because of differences in how they were tested in clinical trials, making apples-to-apples comparisons is difficult — even just for the 3 vaccines authorized by the FDA for use in the United States. In this post, we explore the open questions that remain because of these differences in clinical trial design, the FDA’s authority to help standardize clinical trials, and what lessons can be learned for vaccine clinical trials going forward.

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Impact of Journal of Law and the Biosciences Continues to Grow

The Journal of Law and Biosciences offers high-quality, open-access scholarship at the intersection of the biosciences and law. It is the first fully open-access, peer-reviewed legal journal to focus on these issues. The journal has international impact, with authors from across the globe vying for the opportunity to have their work published in the JLB.

Recently, the Journal of Law and the Biosciences received exciting news in the form of an updated impact factor score. The journal now has an impact factor of 3.583, a substantial increase from the year prior. It ranks #7 out of 151 law journals, an admirable position for the youngest journal included in the rankings. It is also second out of sixteen journals in the medical ethics category, as well as second out of seventeen journals in the legal medicine category.

In honor of this achievement, the Journal has compiled a list of the most impactful articles included in this calculation period.

The Journal continues to publish a wide variety of exciting new material. The most recent issue, which closed in June 2021, contains numerous articles from highly regarded scholars exploring hot-button issues in bioethics. The following excerpts offer a small preview of the wide breadth of analysis contained in the most recent edition.

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Close-up Of Stethoscope On Us Currency And American Flag.

America’s Underinsurance Crisis in the Age of COVID-19

By Dessie Otachliska

The COVID-19 pandemic has shone a light on the underinsurance crisis that has long kept millions of Americans on the precipice of financial disaster — just one unexpected illness or injury away from bankruptcy.

A 2019 Gallup poll showed that 25% of Americans reported delaying treatment for serious medical conditions due to cost concerns — the highest proportion since Gallup first began asking the question in 1991. Even during the pandemic, when medical treatment could mean the difference between life and death, studies show that nearly 1 in 7 Americans would avoid seeking medical care if they experienced key COVID-19 symptoms because of fears associated with the cost of treatment.

These statistics are unsurprising, and the concerns they underscore well-founded: the average treatment costs for COVID patients with symptoms serious enough to require inpatient hospital stays range from $42,486 for relatively mild cases to $74,310 for patients with major complications or comorbidities.

In the pandemic context, hesitance to seek medical treatment due to fear of the associated cost has proved tragically fatal. Darius Settles died after being dissuaded from seeking further COVID-19 treatment due to his uninsured status. The Nashville, TN hospital where Settles originally received care had failed to disclose the possibility that his medical costs would be covered by the federal government. And, despite the availability of reimbursement funds, the hospital nonetheless sent his widow a bill for a portion of his treatment costs.

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image of the US Supreme Court

The Patent Trial and Appeal Board Again Survives Supreme Court Review

By Gregory Curfman

For the generic drug and biosimilar industries, the Supreme Court’s recent decision in United States v. Arthrex, Inc. comes as a relief.

In his opinion, Chief Justice John Roberts allowed the Patent Trial and Appeal Board (PTAB) to survive and to continue to provide an alternative route for generic drugs and biosimilars to gain early market entry.

Patients, who may rely heavily on these less costly alternatives for their prescription drugs, will also benefit significantly from the Court’s decision in this case.

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New Market, Esplanade, Kolkata, 05-23-2021: Due to lockdown, closed market and roadside hawker stalls at S. S. Hogg Market, which usually is heavily crowded as a popular shopping arena.

A Critical Analysis of the Eurocentric Response to COVID-19: Global Classism

By Hayley Evans

The international response to COVID-19 has paid insufficient attention to the realities in the Global South, making the response Eurocentric in several ways.

The first post in this series scrutinized the technification of the international response to COVID-19. The second post looked at how the international pandemic response reflects primarily Western ideas of health, which in turn exacerbates negative health outcomes in the Global South.

This third and final installment analyzes the classist approach to the pandemic response. The international response has paid insufficient attention to the existence of the informal economy and of the needs of those who must work to eat — both of which are found more commonly in the Global South.

This series draws on primary research conducted remotely with diverse actors on the ground in Colombia, Nigeria, and the United Kingdom, as well as secondary research gathered through periodicals, webinars, an online course in contact tracing, and membership in the Ecological Rights Working Group of the Global Pandemic Network. I have written about previous findings from this work here.

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Emergency department entrance.

“Stick to the Science”? FDA, Ethics, and Pandemics

Cross-posted from COVID-19 and The Law, where it originally appeared on February 8, 2021. 

By

Throughout the current pandemic, Dr. Anthony Fauci and other public health experts have called on the government to “stick to the science.” This was at the same time that former President Donald Trump repeatedly undermined scientific expertise and prioritized political interests over responsible public health practices. Yet the particular ways in which the Trump administration mishandled the pandemic can divert attention from more fundamental challenges confronting government actors in any emergency — challenges that respect for science alone is insufficient to address. These challenges concern the norms guiding regulators’ exercise of their power under the law, as well as the proper role of values in public health and public policy more broadly.

FDA has struggled throughout COVID-19 to maintain high standards of integrity, including independence from undue political influence. We see this most clearly in the decisions FDA has faced in applying its power to issue emergency use authorizations (EUAs) for medical countermeasures against COVID-19. FDA’s experience using its emergency powers during COVID-19 speaks to the complex relationship between science and ethics in health policy — between empirical fact finding and normative questions involving ethics and public values.

This post reflects on the ethical implications of FDA’s use of its emergency powers, and suggests opportunities for greater accountability and more systematic decision-making by health regulators moving forward.

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Patient receives Covid-19 vaccine.

What’s the Difference Between Vaccine Approval (BLA) and Authorization (EUA)?

Cross-posted from Written Description, where it originally appeared on June 3, 2021. 

By Jacob S. SherkowLisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

Recently, Pfizer and BioNTech and Moderna announced that they are seeking full FDA approval for their mRNA COVID-19 vaccines — filing, in FDA parlance, a Biologics License Application (BLA). Johnson & Johnson plans to file its own BLA later this year. But currently, all three vaccines are being distributed under a different FDA mechanism, the Emergency Use Authorization (EUA). What’s the difference, under the hood, between these two mechanisms? Why would these companies want to go through the BLA process? And what tools can policymakers use to make the EUA to BLA shift better?

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