By Ana Santos Rutschman
What can the New York City Marathon experience teach those reflecting on ways to increase equity in the transnational allocation of scarce vaccine doses?
Quite a lot, it turns out. I explore this analogy in a recently published article in the Journal of Law, Medicine and Ethics (JLME), Increasing Equity in the Transnational Allocation of Vaccines Against Emerging Pathogens: A Multi-Modal Approach.
By James Lytle
Recent guidance from the U.S. Food & Drug Administration (FDA) encouraged several states to adopt policies that prioritized race or ethnicity in the allocation of monoclonal antibody treatments and oral antivirals for the treatment of SARS-CoV-2.
The guidance proved to be highly controversial, prompting two states, Utah and Minnesota, to withdraw their guidance, and leading a third state, New York, to become the subject of two federal lawsuits that challenge the guidance’s legality: one (Jacobson v. Bassett) brought by a white, non-Hispanic Cornell Law Professor, William Jacobson, in the Northern District of New York (“Jacobson”) and a second (Roberts v. Bassett) initiated by Jonathan Roberts and Charles Vavruska, two white, non-Hispanic residents of New York City in the Eastern District (“Roberts”).
Public health and policy experts have published commentaries on the challenging issues underlying New York’s COVID treatment guidelines and others have offered more detailed guidance, including on this blog, on what criteria should be used in allocating scarce COVID treatments. What follows is focused on the litigation pending in New York and its potential impact on the broader issues at the intersection of the pandemic response and racial equity.
By Sapna Kumar and Ana Santos Rutschman
Research funding contracts can help to safeguard against profound inequities in global allocation and distribution of lifesaving diagnostics, drugs, and vaccines.
During large transnational public health crises, global demand soars for diagnostics, drugs, and vaccines. Although some of these products can be developed within compressed timelines, global production capacity remains limited. Against a backdrop of product scarcity, wealthier countries can out-bid their lower-income counterparts and capture most of the supply during the early stages of pandemics and epidemics. This leaves the vulnerable low-income populations waiting months, or even years, for their turn.
This predictable, inequitable pattern can be held off before the next pandemic. At the research and development (R&D) stage, government funders can bind producers to equity goals through targeted contractual provisions, as we explain in a recently-published Nature Biotechnology article. We summarize our proposals in the following sections. Read More
By Govind Persad, Monica Peek, and Seema Shah
Vaccines are no longer our only medical intervention for preventing severe COVID-19. Over the past few months, we have seen the arrival and wider availability of treatments such as monoclonal antibodies (mAbs), and more recently, of novel oral antiviral drugs like Paxlovid and molnupiravir.
The recent Delta and Omicron surges have made these therapies scarce. The Delta variant led the federal government to resume control over mAb supply and promulgate allocation guidelines. The Omicron variant exacerbated scarcity because only one of the currently available mAbs, sotrovimab, appears to be effective against it. While Paxlovid and molnupiravir are effective against Omicron, both will likely be in short supply for many months. Paxlovid is currently constrained by a lengthy manufacturing process. Molnupiravir — which is substantially less effective — is contraindicated for use in patients under 18 and not recommended for use during pregnancy.
To allocate COVID-19 vaccines, the CDC’s Advisory Committee on Immunization Practices, the National Academies of Sciences, Engineering and Medicine (NASEM), and the World Health Organization (WHO) identified ethical goals for prioritization, such as maximizing benefit and minimizing harm, mitigating health inequities, and reciprocity. These committees, particularly the NASEM and WHO committees, included ethics experts as well as experts in social science, biology, and medicine. Current federal guidelines for therapy allocation, in contrast, do not identify ethical objectives or involve ethics expertise.
In an open-access Viewpoint in Clinical Infectious Diseases, we identify ethical goals for the allocation of scarce therapies. We argue that the same ethical goals identified for vaccine allocation–in particular maximizing benefit, minimizing harm, and mitigating health inequities — are also relevant for therapy allocation. Because many people have now taken steps to mitigate pandemic scarcity, for instance by protecting themselves through vaccination, we argue that reciprocity is also relevant.
By Rachele Hendricks-Sturrup
On April 21, 2021, the European Commission released a “first-ever” legal framework on artificial intelligence (AI) in an attempt to address societal risks associated with AI implementation.
The EU has now effectively set a global stage for AI regulation, being the first nation of member states to create a legal framework with specific intent to address or mitigate potentially harmful effects of broad AI implementation.
Within the proposed framework, the Commission touched on a variety of considerations and “high-risk” AI system scenarios. The Commission defined high-risk AI systems as those that pose significant (material or immaterial) risks to the health and safety or fundamental rights of persons.
This post outlines four key considerations in the proposal with regard to health: 1) prioritizing emergency health care; 2) law enforcement profiling as a social determinant of health; 3) immigrant health risk screening; and 4) AI regulatory sandboxes and a health data space to support AI product commercialization and public health innovation.
By Jenna Becker
Hospitals use artificial intelligence and machine learning (AI/ML) not only in clinical decision-making, but also to allocate scarce resources.
These resource allocation algorithms have received less regulatory attention than clinical decision-making algorithms, but nevertheless pose similar concerns, particularly with respect to their potential for bias.
Without regulatory oversight, the risks associated with resource allocation algorithms are significant. Health systems must take particular care when implementing these solutions.
Cross-posted from Harvard Law Today, where it originally appeared on February 2, 2021.
By Jeff Neal
Should smoking be among the pre-existing health risks that qualify people for priority access to the COVID-19 vaccine? In a Zoom interview with Harvard Law Today, public health expert Carmel Shachar J.D./M.P.H. ’10 says the answer is yes.
CDC guidelines, which most states are following as they launch mass vaccination programs, say people with certain underlying medical conditions that put them at greater risk for hospitalization or death if they contract COVID-19 (also known as co-morbidities) should receive access to the vaccine before the general population. In Massachusetts, these individuals will be eligible to receive the vaccine in Group 4 of Phase 2 of the state’s vaccination rollout plan. But many have been surprised to see smoking listed among the qualifying conditions, alongside cancer and heart disease.
Shachar, the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, says that smoking is often the result of structural and biological factors that make it more prevalent in historically marginalized communities, and that denying priority access for smokers would reinforce existing inequities. More practically, she says, “every time a person gets vaccinated, it’s good for the community.”
Cross-posted from Harvard Law Today, where it originally appeared on December 3, 2020.
By Jeff Neal
The race to approve and distribute a vaccine for COVID-19 got a huge shot in the arm this week.
On Tuesday, the United Kingdom approved a vaccine developed by pharmaceutical giant Pfizer. On the same day in the United States, a panel of experts advising the Centers for Disease Control and Prevention recommended a first-stage plan for distributing the vaccine to some of the most at-risk Americans. Separately, another advisory committee is set to meet twice in the coming weeks to evaluate for the U.S. Food and Drug Administration the safety and efficacy of both the Pfizer vaccine and a similar one produced by Moderna.
To better understand the impact of these developments, Harvard Law Today recently spoke with public health expert Carmel Shachar J.D./M.P.H. ’10, the executive director of the Petrie-Flom Center for Health Policy, Biotechnology, and Bioethics at Harvard Law School, about the vaccine, who is likely to get it first, and whether employers and states can require people to get vaccinated.
By Ross D. Silverman, Katharine J. Head, and Emily Beckman
As professors studying public health policy, narrative medicine, and how providers and the public communicate about vaccines, we recognize the power and peril of using the rhetorical tool of metaphors in vaccination and, more broadly, the COVID-19 response efforts.
Metaphors can be an effective shorthand to help people understand complex ideas, but we also must remain cognizant of the many ways metaphors may distort, divide, or misrepresent important details.
By Beatrice Brown
Several states, including Texas, Ohio, and Alabama, have dangerously and incorrectly deemed abortions a non-essential or elective procedure during the COVID-19 pandemic. The stated reason for these orders is to conserve personal protective equipment (PPE), a scarce, important resource for protecting health care workers treating COVID-19 patients.
However, these policies restricting abortion are unlikely to conserve PPE, and more importantly, they mischaracterize the nature and importance of abortions.