Child with bandaid on arm.

Should Vaccinating Children Off-Label Against COVID-19 Be Universally Prohibited?

By Govind PersadPatricia J. Zettler, and Holly Fernandez Lynch

As children are experiencing the highest rates of COVID-19 in many states, can efforts to universally preclude vaccination of those under 12 until the U.S. Food and Drug Administration (FDA) specifically authorizes use in that age group be justified?

In a case commentary published today in Pediatrics, we argue that the answer is no.

This view diverges from the positions of the American Association of Pediatrics, FDA, and the U.S. Centers for Disease Control and Prevention (CDC). In fact, the CDC, which controls the nation’s supply of COVID-19 vaccines, has taken steps to currently ban the practice of vaccinating youth under the age of 12.

We acknowledge that recommendations to widely vaccinate 5-11 year olds should await FDA and CDC guidance (which is expected soon, given upcoming advisory committee meetings). But, especially at the lower dose offered in pediatric clinical trials, we think that off-label pediatric administration of approved COVID-19 vaccines, like Pfizer’s Comirnaty mRNA vaccine, should be treated like other off-label uses and left to the individual risk-benefit judgments of doctors and patients (or here, parents).

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Empty Classroom In Elementary School With Whiteboard And Desks.

Addressing School Discipline Disparities Through the Health Justice Framework

By Alexis Etow and Thalia González*

As an interdisciplinary legal scholar and public health attorney studying how education policies fit into the broader antiracist health equity agenda, health justice serves as both a conceptual framework for reform for legal academics and an accessible roadmap for change for policymakers and public health law professionals. Health justice functions to extend what has been previously accepted as within the health domain beyond traditional health care settings, systems, or laws. This broad applicability leaves ripe the opportunity to employ it to a broad range of health-impacting laws, policies, and systems that may not be designed or previously conceptualized as public health.

Consider, for example, school discipline and policing. Researchers and advocates have long-documented the disparate punishment and policing of Black, Indigenous, people of color (BIPOC) students compared to their white peers. For students with disabilities, especially those with intersectional identities, the risk factors and impacts of such policies are amplified. In the case of Black girls with disabilities, data shows that they experience the highest disparity for rates of referrals to law enforcement: six times more than white, non-disabled female students.

During COVID-19 and school closures, the disproportionality of these practices not only persist, but schools now employ new models of exclusion and police practices. This includes students remaining in Zoom waiting rooms during instructional time, resulting in unexcused absences, learning loss, and eventually truancy prosecution.

Despite evidence of the significant co-influential nature of health and education and specific health-harming effects of school discipline and policing — e.g., negative effect on students’ mental health, diminished health protective factors, disrupted educational attainment, threat to safety and wellbeing, and increased risk for justice system involvement — public health has been largely underemphasized in reform efforts and overlooked by the health law community. This is where a health justice approach is critical: it knits together and affirms that health and public health law professionals have key roles to play in education policy, law, and practice. It also places the health-harming effects of school discipline and policing squarely in the domain of public health law and prioritizes legal and policy responses with health equity at the forefront.

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Brown Gavel With Medical Stethoscope Near Book At Wooden Desk In Courtroom.

Health Justice, Structural Change, and Medical-Legal Partnerships

By Liz Tobin-Tyler and Joel Teitelbaum

To us, health justice means change.

Changes to norms and attitudes, to systems and environments, to law and policy, to resource and opportunity distribution. Not cosmetic or peripheral change, but wide-scale, systemic change. For health justice to be realized — for all people to reach their full health potential — laws and policies must be geared toward restructuring the systems, practices, and norms that have heretofore advantaged some groups over others, and thus given them greater opportunity for good health, economic and social prosperity, and greater longevity.

We recognize that this kind of change is profoundly challenging, both biologically and structurally. Biologically, because humans are programmed to do what’s comfortable, and what’s comfortable is what’s already known. Structurally, because of the nation’s unique political, social, and cultural attributes. Some of these attributes include a strong sense of individualism, and thus an entrenched unwillingness to prioritize community benefit over individual choice; limited governmental power; capitalism; unprecedented wealth with massive inequality; resistance to growing racial and ethnic diversity; over-spending on the downstream consequences of the failure to invest in upstream wellness; and a willingness to enact and maintain policies and practices that privilege some lives over others.

For these reasons, we are not naïve about the prospects for major change in a relatively short period of time, but neither are we cowed by the challenge. We embrace the opportunity to get uncomfortable, to challenge the racist, gender-based, and ableist norms and attitudes in all forms that harm health and well-being, to raise awareness of the inert systems that perpetuate health injustice, and to promote innovative and progressive law and policy change.

One of the ways that we apply our approach to health justice is our work to develop and advance medical-legal partnerships (MLPs), as both an expert consultant (Liz) to and Co-Director (Joel) of the National Center for Medical-Legal Partnership.

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Blue stethoscope with gavel on white background

Equipping the Next Generation of Health Justice Leaders

By Yael Cannon

Health justice begins with exploring and understanding health disparities and the role of law in facilitating the social, political, and economic determinants at their roots. It requires naming structural racism — and the many forms of subordination that flow from it — as a public health crisis and recognizing that health justice is racial justice. Most importantly, health justice requires us to partner with affected communities to leverage law and policy to address and eliminate the root causes of disparities.

Those of us at schools of law and medicine, and other academic institutions who are training the next generation of lawyers, policy advocates and policymakers, doctors, nurses, and other health professionals have a special responsibility to equip our students with the knowledge, skills, and values they need to ensure that everyone has an equal chance at health and well-being.

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WASHINGTON, DC - OCT. 8, 2019: Rally for LGBTQ rights outside Supreme Court as Justices hear oral arguments in three cases dealing with discrimination in the workplace because of sexual orientation.

The Many Harms of State Bills Blocking Youth Access to Gender-Affirming Care

By Chloe Reichel

State legislation blocking trans youth from accessing gender-affirming care puts kids at risk, thwarts physician autonomy, and potentially violates a number of federal laws, write Jack L. Turban, Katherine L. Kraschel, and I. Glenn Cohen in a viewpoint published today in JAMA.

So far this year, 15 states have proposed bills that would limit access to gender-affirming care. One of these bills, Arkansas’ HB1570/SB347, already has become law.

This legislative trend should be troubling to all, explained Cohen, Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. In an email interview, he highlighted “how exceptionally restrictive these proposed laws are,” adding that they are “out of step with usual medical, ethical, and legal rules regarding discretion of the medical profession and space for parental decision-making.”

Turban, child and adolescent psychiatry fellow at Stanford University School of Medicine also offered further insight as to the medical and legal concerns these bills raise over email.

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basketball on court

Sports Medicine in the Era of COVID-19

By Brian Feeley and William Levine

The world of sports and sports medicine offers a valuable window into understanding key developments in the COVID-19 pandemic and the broader health and equity issues at play.

Sports medicine, the practice of keeping athletes of all abilities in their peak through a combination of surgery, rehabilitation, and medications, has grown exponentially in the past few decades, with a concomitant rise in the popularity of professional and recreational sports.

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Empty classroom.

Can Schools Require the COVID-19 Vaccine? Education, Equity, and the Courts

By Emily Caputo and Blake N. Shultz

As school systems consider policy options for the spring semester, both vaccination requirements and proposals to address inequities in access to education may be top of mind. However, policymakers should be aware of the possible legal challenges they may face.

The COVID-19 pandemic has created an educational crisis in the United States by disrupting the learning of millions of students across the country. School closures, remote learning, and generalized societal stress have all raised serious concerns about persistent harm to adolescent learning and development — particularly among low-income and minority students.

While the pandemic has exposed widespread inequities in educational opportunity, it has also revealed the relative inability of the courts to promote access to education. A recent California lawsuit illustrates the manner in which students must rely on state-level, rather than federal, protections to ensure equal access to education. And COVID-19 vaccination requirements, which could facilitate a return to in-person education, are likely to result in lawsuits, and may be struck down by a skeptical and conservative Supreme Court.

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Several vaping devices on a table

E-Cigarette Laws that Work for Everyone

By Daniel Aaron

The Trump Administration has retreated from proposed tobacco regulations that experts generally agree would benefit public health. The regulations would have included a ban on flavored e-cigarettes, a favorite of children who use e-cigarettes. Currently millions of youth are estimated to be addicted to e-cigarettes.

The rules also could have reduced nicotine in cigarettes to non-addictive levels. Nicotine is the addicting substance largely responsible for continued smoking. If nicotine were “decoupled” from smoking, smokers might turn to other sources of nicotine, rather than continuing to smoke. Smoking is the leading cause of preventable death in the U.S., killing about 500,000 Americans each year, or just about the number of Americans who died in World War I and World War II combined.

Part of the difficulty in regulating e-cigarettes is that, unlike cigarettes, they offer benefits and harms that differ across generations. This concern is called intergenerational equity. How can a solution be crafted that serves all Americans?

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An adult hold the hand of a child with an IV

Teva to Resume Production of Critical Pediatric Oncology Drug: Too Little, Too Late

By Beatrice Brown

In my last blog post, I reflected on the ethical issues relevant to a critical shortage of a widely used pediatric oncology drug, vincristine. The shortage occurred after one of two pharmaceutical companies producing the drug, Teva, withdrew from the market, and the other, Pfizer, was unable to keep up with the demand due to manufacturing delays. On November 13, Teva announced that they would resume production of vincristine. The announcement stressed that they have decided to re-introduce the product because of the anticipated lack of “reliable single supply in the near term.” They also seemed to shift the moral blame from their decision, stating that “When Teva removed vincristine from the market earlier in the year there was no indication at all of a possible shortage” and that they assumed that Pfizer, which supplied 97% of the market, could easily absorb the demand. Furthermore, Teva emphasized that before discontinuing a product, they “always evaluate the need” for it, noting the caveat that they usually do not know supply challenges that other manufactures may be facing. However, as noted by Forbes, there will be no “short-term impact on the ongoing shortage” as a result of Teva’s decision, as their new supply of vincristine will not be available until early in 2020.

I raised the question in my last blog post on the shortage of vincristine of whether pharmaceutical companies have a moral obligation to continue producing a critical drug, even if the decision is announced in advance. I argued that it would have been more ethically permissible for Teva to have reduced production over time, eventually halting production, in order to alleviate the issue of manufacturing delays that Pfizer subsequently faced. I would like to further explore this question in light of Teva’s recent decision to resume production. Read More