Society or population, social diversity. Flat cartoon vector illustration.

Unequal Representation: Race, Sex, and Trust in Medicine — COVID-19 and Beyond

By Allison M. Whelan*

The COVID-19 pandemic has given renewed importance and urgency to the need for racial and gender diversity in clinical trials.

The underrepresentation of women in clinical research throughout history is a well-recognized problem, particularly for pregnant women. This stems, in part, from paternalism, a lack of respect for women’s autonomy, and concerns about women’s “vulnerability.” It harms women’s health as well as their dignity.

Over the years, FDA rules and guidance have helped narrow these gaps, and recent data suggest that women’s enrollment in clinical trials that were used to support new drug approvals was equal to or greater than men’s enrollment. Nevertheless, there is still progress to be made, especially for pregnant women. In the context of COVID-19 research, one review of 371 interventional trials found that 75.8% of drug trials declared pregnancy as an exclusion criteria, a concerning statistic given that recent data suggest that contracting COVID-19 during pregnancy may increase the risk of preterm birth.

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Illustration of a man and a woman standing in front of a DNA helix

Research Reveals Potential Concerns About Genetic Testing for Suicide Risk

By Brent Kious, Anna Docherty, Leslie Francis, Teneille Brown, Jeffrey Botkin, Douglas Gray, Brooks Keeshin, Louisa Stark, Brieanne Witte, and Hilary Coon

Companies that offer direct-to-consumer genetic testing (DTC-GT) will soon be able to provide scores that estimate suicide risk.

Our recent study, appearing in Genetics in Medicine, the official journal of the American College of Medical Genetics and Genomics (ACMG) raises ethical questions about how these risk scores will be understood.

The causes of suicide are complex. Many risk factors intersect: psychiatric symptoms like depression, different life stressors, family history, access to lethal firearms, and substance abuse, among many others.

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image of the US Supreme Court

What the Supreme Court’s ACA Ruling Might Mean for Nonprofit Hospitals

By Jacob Madden

California v. Texas, a pending Supreme Court case that concerns the constitutionality of the Affordable Care Act (ACA)’s individual mandate, could have profound implications for the standards to which nonprofit hospitals are held.

The ACA’s individual mandate requires people to have health insurance or otherwise pay a penalty. While the Court previously upheld the individual mandate as being constitutional under Congress’ taxation power in the 2012 case National Federation of Independent Business v. Sebelius, it may not do so again. For one, the 2017 Trump tax cuts effectively eliminated the individual mandate’s penalty, raising the question of whether the individual mandate is still a valid exercise of Congress’ taxation power. And conservative Judge Amy Coney Barrett’s confirmation, filling the late Justice Ruth Bader Ginsburg’s seat, has significantly changed the composition of the court.

If the Court strikes down the individual mandate, the rest of the ACA could be in jeopardy, depending on the specifics of the ruling. The Court has several options: sever the individual mandate from the ACA and keep the ACA alive, strike down the ACA in part, or strike down the ACA entirely.

The immediate concern, should the Court strike down the ACA entirely, is that tens of millions of Americans likely would lose their health insurance and other protections afforded by the law. Another, albeit lesser known concern, is that we would lose § 501(r).

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Adult and child holding kidney shaped paper on textured blue background.

Nudging Organ Donation in the United States

Cross-posted from Harvard Law Today, where it originally appeared on November 13, 2020. 

By Chloe Reichel

Nationally and globally, demand for organ transplants outstrips supply. In the United States last year, 19,267 donors made a record-setting 39,718 transplants possible, but nearly 109,000 Americans still remain on the organ transplant waiting list.

Cass Sunstein ’78, Robert Walmsley University Professor and former Administrator of the White House Office of Information and Regulatory Affairs in the Obama administration, believes “Nudge theory” might help bridge this gap between supply and demand.

Sunstein joined scholars and leaders in transplant services on Friday, Nov. 6 to discuss strategies to boost rates of organ donation at “Nudging Organ Donation: Tools to Encourage Organ Availability,” an event hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

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lady justice.

Feminist Judgments: Rewritten Health Law Opinions: Video with Seema Mohapatra

The Health Law Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts.

The workshop is led by Professor I. Glenn Cohen, and presenters come from a wide range of disciplines and departments.

In this video, Seema Mohapatra discusses the volume she is co-editing with Lindsay Wiley, “Feminist Judgments: Rewritten Health Law Opinions,” which she presented at the Health Law Policy workshop on November 16, 2020. Watch the full video below:

abortion protest outside supreme court.

Reproductive Rights vs. Reproductive Justice: Why the Difference Matters in Bioethics

By Danielle M. Pacia

When conceptualizing the pursuit of reproductive freedom, we must acknowledge the ways that our systems and structures fail Black, Indigenous and people of color (BIPOC) populations.

2020 has been a year filled with anxiety and anger over the COVID-19 pandemic’s disproportionate negative effects on BIPOC populations. Black Lives Matter protests after the unjust deaths of Breonna Taylor, Mia Green, George Floyd, Rayshard Brooks, Riah Milton, and many others whose lives ended far too soon have prompted an overdue awakening. This has caused some to reexamine racism on a personal and institutional level. Like many disciplines in our country, the field of bioethics has begun to recognize how the field reinforces racism within its scholarship.

Part of this effort includes a critical examination of the frameworks we employ when analyzing bioethical subjects and events, and how they may exclude the historical contributions and narratives of BIPOC populations. Merely acknowledging racism is not enough.

Here, I will explain the differences in the terms reproductive justice and reproductive rights and advocate use of the reproductive justice framework instead of the reproductive rights framework. Within bioethics and health law policy, there is often a lack of clarity between the terms, which, in turn, leaves their important conceptual and historical differences ignored.

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Close-up of a stethoscope on an American flag

Why Justice is Good for America’s Health

By Dayna Bowen Matthew

Justice is good for health [and] . . . health is the byproduct of justice.

— Norman Daniels, Bruce Kennedy & Ichiro Kawachi (Boston Review, 2000)

Among the most salient lessons to be learned from the coronavirus pandemic are that unjust laws produce unjust health outcomes, and that justice is just plain good for America’s health.

Health justice is the moral mandate to protect and advance an equal opportunity for all to enjoy greatest health and well-being possible. Health justice means that no one person or group of people are granted or excluded from the means of pursuing health on an inequitable basis. To achieve health justice, societal institutions such as governments and health care providers must act to advance equality, by increasing fairness and decreasing unfairness of their current and historic impacts on populations.

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(Institute for the feeble-minded, Lincoln, Ill. / Library of Congress)

Why Buck v. Bell Still Matters

By Jasmine E. Harris

In 1927, Buck v. Bell upheld Virginia’s Eugenical Sterilization Act, authorizing the state of Virginia to forcibly sterilize Carrie Buck, a young, poor white woman the state determined to be unfit to procreate.

In less than 1,000 words, Justice Oliver Wendell Holmes, writing for all but one of the Justices of the Court, breathed new life into an otherwise fading public eugenics movement.

More than 70,000 people (predominantly women of color) were forcibly sterilized in the twentieth century.

Buck is most often cited for its shock value and repeatedly, for what is, perhaps, its most famous six words: “Three generations of imbeciles are enough.” While this may be the most provocative language in the opinion, it is not the most noteworthy.

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Empty hospital bed.

Addressing Health Inequities in End-of-Life Care in the Era of COVID-19

By Megan J. Shen

Inequities in end-of-life care have been exacerbated by the COVID-19 pandemic, but have yet to receive the same level of attention as some other health disparities brought to the fore recently.

Quality end-of-life care is focused on reducing human suffering and aiding patients in receiving support during the dying process.

Traditionally, poor quality end-of-life care involves the overtreatment of patients, as in the case of continuing to treat incurable cancer aggressively. However, COVID-19 has introduced new challenges in achieving quality care at the end of life. Specifically, it is now more challenging to reduce human suffering at the end of life because of limitations in providing access to two critical resources: (1) medical care that can relieve physical suffering in the dying process and (2) support, such as loved ones, as well as needed psychological, spiritual, and physical support to cope with the existential threat of dying. COVID-19 has made access to both of these a greater challenge for underrepresented minorities.

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Minneapolis, MN / USA - May 26 2020: Black Lives Matter, "I Can't Breathe" Protest for George Floyd.

Expendable Lives and COVID-19

By Matiangai Sirleaf

Two French doctors recently appeared on television and discussed using African subjects in experimental trials for an antidote to the novel coronavirus (COVID-19).

“Shouldn’t we do this study in Africa, where there are no masks, no treatment, no resuscitation, a bit like some studies on AIDS, where among prostitutes, we try things, because they are exposed, and they don’t protect themselves. What do you think?” asked Jean-Paul Mira, head of the intensive care unit at the Cochin Hospital in Paris on April 1, 2020.

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