Female hand writing signature on the paper document.

How to Construct Better Organ Donation Policy and Achieve Health Equity

By James R. Jolin

The United States is facing an organ donation crisis, with massive gaps between supply and demand.

Per estimates from the Department of Health and Human Services (HHS), over 106,000 Americans are currently awaiting this life-saving medical treatment. Further, the burden of this shortage falls unequally:  in 2020, while approximately 48% of white patients in need of transplants received an organ, only 27% of Black patients secured one.

The stakes are too high to allow the organ donation crisis to proceed in the U.S. without bold intervention. But with many policy options on the table, unresolved ethical concerns, and a patchwork of organ donation laws across the country, the proper path forward is not immediately clear.

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Doctor or surgeon with organ transport after organ donation for surgery in front of the clinic in protective clothing.

Pig Hearts for Humans and the FDA

By Jacob Balamut

David Bennett, a man who recently underwent the world’s first successful xenotransplantation organ surgery, died last month after a sudden and as yet unexplained period of rapid deterioration.

Bennett, who was 57 years old, had been suffering from end-stage heart disease. With limited options for treatment, he underwent an experimental emergency procedure to replace his damaged heart with a genetically modified pig’s heart. The pig was genetically modified to limit the likelihood that Bennett’s immune system would reject the heart.

Many researchers and clinicians alike see the potential for genetically modified animal organs to serve as a solution to our organ transplant and supply issues. The Health Resources and Services Administration estimates that 17 people die per day on the candidate waiting list. These deaths are the result of a lack of supply of organs, which has been a longstanding issue within the United States.

However, currently, the U.S. Food and Drug Administration (FDA) has not approved any genetically modified or pure animal organs for xenotransplantation in humans. For the surgery to go forward in Bennett’s case, the team had to submit a request to the FDA seeking to use the pig heart in the emergency procedure (so-called “compassionate use”). The lack of approved xenotransplantation products stems from a lack of safety data and concerns regarding the potential for cross-species infections to occur.

In 2016, the FDA updated previously existing guidance for xenotransplantation. The purpose of the guidance was to inform the industry of how the FDA would be handling xenotransplantation applications and to provide recommendations.  In order for xenotransplantation products to be approved, the following process must occur.

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Waiting area in a doctor's office

Churntables: A Look at the Record on Medicaid Redetermination Plans

By Cathy Zhang

The COVID-19 Public Health Emergency (PHE) expires at the end of this week, with Department of Health and Human Services (HHS) Secretary Xavier Becerra expected to renew the PHE once more to extend through mid-July.

When the PHE ultimately expires, this will also trigger the end of the Medicaid continuous enrollment requirement, under which states must provide continuous Medicaid coverage for enrollees through the end of the last month of the PHE in order to receive enhanced federal funding. This policy improves coverage and helps reduce churn, which is associated with poor health outcomes.

After the PHE, states can facilitate smooth transitions for those no longer eligible for Medicaid by taking advantage of the full 12- to 14- month period that the Centers for Medicare & Medicaid Services (CMS) has established for redetermining eligibility.

In August 2021, CMS released guidance giving states up to 12 months following the end of the PHE to redetermine whether Medicaid enrollees were still eligible and renew coverage. Last month, CMS released new guidance specifying that states must initiate redeterminations and renewals within 12 months of the PHE ending, but have up to 14 months to complete them. The agency is encouraging states to spread its renewals over the course of the full 12-month unwinding period, processing no more than 1/9th of their caseloads in a month, in order to reduce the risk of inappropriate terminations.

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Emergency room.

Hospitals in Poor Rural Counties Face the Greatest Financial Threat from COVID

By Robert I. Field and Anthony W. Orlando

The latest wave of COVID cases and hospitalizations has raised concerns about the financial resilience of many hospitals in the United States. Throughout the pandemic, we have witnessed shortages of medical supplies, exhaustion of frontline workers, and the overflow of patients beyond the physical capacity of hospital beds and buildings. Now, after nearly two years of repeated COVID surges, there is a real danger that some institutions might run so low on funding that they will need to downsize or close altogether.

Large hospitals in metropolitan areas have, for the most part, weathered the storm. Ample financial resources enabled them to survive with fewer lucrative elective procedures and sudden overwhelming demand for less profitable intensive care for COVID patients. But in many parts of the country, especially rural regions, smaller hospitals lack such financial cushions. For them, COVID could be an existential threat.

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Globe and vaccine.

COVID ‘Compromise’ on International IP Underscores Need for New Approach

By Cynthia M. Ho

The leaked compromise regarding a “waiver” of international intellectual property (IP) obligations under the TRIPS Agreement for World Trade Organization (WTO) members has met harsh criticism as a shadow of the original proposal to waive international obligations regarding patent, trade secret, and copyright obligations relating to any COVID vaccine, treatment, diagnostic, or personal protective equipment (PPE).

The compromise excludes diagnostics, treatments, and PPE. It only narrowly modifies compulsory licenses of patents covering COVID vaccines. Moreover, it imposes additional restrictions on use of compulsory licenses. But still, multinational pharmaceutical manufacturers have protested even these modest changes from the status quo, arguing that there is no IP problem that needs to be fixed.

Clearly there is a problem. It has taken 18 months since the original Indian and South African proposal to get to this limited compromise, while gross vaccine inequity between wealthy and poor countries continues. In addition, the leaked compromise between four WTO members is still being debated — and even if agreement can be reached, it needs agreement of over 100 other WTO members. We need a new approach.

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Melbourne, Australia - 1st November 2021: A person wearing full PPE holds a vial of sotrovimab medicine covid-19 virus treatment. It is under an emergency use authorization to treat covid in Australia.

Litigation Challenges Prioritization of Race or Ethnicity in Allocating COVID-19 Therapies

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.

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close up of hands signing contract.

Using Contracts to Lessen Inequities in Access to Medicines in Pandemics and Epidemics

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

Washington DC 09 20 2021. More than 600,000 white flags honor lives lost to COVID, on the National Mall. The art installation " In America: Remember" was created by Suzanne Brennan Firstenberg.

Depoliticizing Social Murder in the COVID-19 Pandemic

­­By Nate Holdren

Lire en français.

The present pandemic nightmare is the most recent and an especially acute manifestation of capitalist society’s tendency to kill many, regularly, a tendency that Friedrich Engels called “social murder.” Capitalism kills because destructive behaviors are, to an important extent, compulsory in this kind of society. Enough businesses must make enough money or serious social consequences follow — for them, their employees, and for government. In order for that to happen, the rest of us must continue the economic activities that are obligatory to maintain such a society.

That these activities are obligatory means capitalist societies are market dependent: market participation is not optional, but mandatory. As Beatrice Adler-Bolton has put it, in capitalism “you are entitled to the survival you can buy,” and so people generally do what they have to in order to get money. The predictable results are that some people don’t get enough money to survive; some people endure danger due to harmful working, living, and environmental conditions; some people endure lack of enough goods and services of a high enough quality to promote full human flourishing; and some people inflict the above conditions on others. The simple, brutal reality is that capitalism kills many, regularly. (The steadily building apocalypse of the climate crisis is another manifestation of the tendency to social murder, as is the very old and still ongoing killing of workers in the ordinary operations of so many workplaces.)

The tendency to social murder creates potential problems that governments must manage, since states too are subject to pressures and tendencies arising from capitalism. They find themselves facing the results of social murder, results they are expected to respond to, with their options relatively constrained by the limits placed on them by capitalism. Within that context governments often resort to a specific tactic of governance: depoliticization.

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Ponta Grossa/PR/Brazil - July 15th 2020: Home office, working from home layout during covid-19 pandemic

Employers Should Bear Responsibility for Making Remote Work Environments Accessible

By Christopher A. Riddle

Remote work meaningfully facilitates inclusion of people with disabilities in the labor market.

But, to truly fulfill its promise, employers must also take steps to ensure that remote work accommodations are not made at the expense of the employee, simply because their labor is conducted in their own home.

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Person in nursing home.

Struggles Over Care Will Shape the Future of Work

By Andrew Milne

The future of work will largely be the future of care work. Health care is rapidly becoming the largest employer in the U.S., expanding to serve the fastest growing demographic, aging seniors. As a lawyer for seniors in need of free legal services, I see my clients struggle to access care made scarce by the for-profit care industry’s understaffing and underpaying of workers attempting to meet the growing need. The future of work and of aging will be shaped by struggles over care from both giving and receiving ends, perhaps against those profiting in between.

Recall that the first COVID-19 outbreak in the U.S. spread between nursing homes. These facilities, like most nursing homes, are for-profit businesses that pad their margins by cutting labor costs. The resulting understaffing has deadly effects in normal times. The pandemic intensified those effects, as underpaid care workers, forced to work at multiple facilities to survive, unintentionally spread the virus between facilities.

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