Syringe and vials of vaccine.

Racial Inclusivity in COVID-19 Vaccine Trials

By Colleen Campbell

Recent calls for racial inclusivity in vaccine trials, which often rely on genetic rationales while emphasizing medical distrust among African Americans, unfortunately lack an equally robust critique of medical racism and the ongoing reasons for this distrust.

Even though race lacks genetic meaning, the COVID-19 discourse is rife with biological notions of race. Because of [g]enetics related to racial differences” African Americans must be involved in clinical trials, said Dr. Larry Graham in an NBC News article. He continued: “We must be sure it works in Black folks.” For this reason, companies like biotech firm Moderna are enlisting Black religious leaders to heavily recruit African American participants. They are also exploiting networks previously used for HIV clinical trials.

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Protest against Brazil's President Jair Bolsonaro.

Between Gross Negligence and Genocide: Brazil’s Failed Response to COVID-19

By Octávio Luiz Motta Ferraz

When my first piece in this series was published on May 12th, Brazil counted 11,000 deaths caused by COVID-19. A new health secretary had just been appointed to replace Dr. Luiz Henrique Mandetta, who was sacked for disagreeing with President Jair Bolsonaro’s views that the pandemic (which he infamously called a “little flu”) was a conspiracy of the media and that public health measures should be immediately lifted to avoid damage to the economy.

Fast forward to September 10th and the situation, predictably, has gotten significantly worse. Brazil now counts 128,539 deaths, the second highest number in absolute terms (after the U.S., where the death toll is 190,872), and the sixth in per capita terms, with just over 60 deaths per 100,000 population. When Brazil reached the 100,000 deaths mark in early August, the president thought it more appropriate to use his Twitter account to celebrate his football team’s win at the local tournament than to make any statement on the health crisis.

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Madison, Wisconsin / USA - April 24th, 2020: Nurses at Reopen Wisconsin Protesting against the protesters protesting safer at home order rally holding signs telling people to go home.

Great Responsibility: Navigating Moral Hazards During COVID-19

By Jacqueline Salwa

Younger people may be driving the COVID-19 pandemic in part because they perceive the costs of complying with public health measures as higher and the expected benefits as lower compared with older individuals.

”Indemnifying Precaution: Economic Insights for Regulation of a Highly Infectious Disease,” a paper recently published in the Journal of Law and the Biosciences, explores how to align costs and benefits so that individuals of all ages adhere to precautions.

Younger people tend to experience less severe symptoms from COVID-19 infection, and may be disproportionately affected by other aspects of the pandemic.  These include depression from lack of social interaction, stifled career advancement, and difficulties with providing for dependents.  Compared to younger people, older people have a greater chance of being settled down, retired, and not responsible for dependents. As a result, those that  receive the least benefit from taking precautions, and incur the greatest personal costs for abiding by these precautions, have a lack of incentive to follow precautionary public health measures. This is known, in economic terms, as a moral hazard.

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Uganda Flag Against City Blurred Background At Sunrise Backlight 3D Rendering.

Ugandan Court Decision Enshrines Access to Basic Maternal Health Care as a Right

By Moses Mulumba

On August 19, 2020, the Constitutional Court of Uganda passed a landmark judgment in which it pronounced that the Government of Uganda’s omission to adequately provide basic maternal health care services and emergency obstetric care in public health facilities violates the right to health, the right to life, and the rights of women as guaranteed under the country’s Constitution.

Uganda’s maternal mortality rate is unacceptably high, at 343 per 100,000 live births. This means that Uganda loses 15 women each day from pregnancy and child birth related causes.

In its judgment, the Court directed the Government of Uganda to prioritize and provide sufficient funds in the national budget for maternal health care. The Court also ordered, through the Health Minister, that all the health care workers who provide maternal health care services in Uganda be fully trained and all health centers be properly equipped within the next two financial years (2020/2021 and 2021/2022).

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corridor with hospital beds

Hospitals Bear the Costs of Detention and Incarceration

By Blake N. Shultz and Pooja Agrawal

While individuals with recent criminal justice involvement represent only 4.2% of the population, they make up 8.5% of all emergency department (ED) expenditures, which translates to an additional $5.2 billion in annual spending across the health care sector.

The federal government has complete control over access to medical care for incarcerated individuals and immigrants in detention facilities, and is primarily responsible for the quality of the sanitation, nutrition, and shelter accommodations. Despite this level of control, conditions in many detention facilities and prisons are exceptionally poor.

Over eighty percent of recently released prisoners are uninsured, and upon re-entry into society they struggle to obtain quality medical care for both pre-existing conditions and those that may have been caused or exacerbated by detention.  As they often do not have a medical home, upon release many will present to emergency departments (EDs) for their health care needs, and, because of the low rates of insurance coverage, hospitals are left to pick up the bill for the gaps in care created by the government’s deficiencies.

The disaggregation of government detention facilities and financial responsibility for downstream health care costs of released individuals creates a “regulatory moral hazard,” in which the government has little incentive to invest in the health and health care of incarcerated and detained individuals. In the absence of federal reform incentivizing investment and reducing cost-shifting to the health care sector, hospital systems should build interdisciplinary care teams focused on formerly incarcerated and detained individuals while investing in comprehensive, community-based health care.

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Oxygen mask as part of artificial lungs ventilation machine in surgery room, closeup.

Arizona’s Crisis Standards of Care and Fair Allocation of Resources During COVID-19

By Govind Persad

As COVID-19 cases spiked in Arizona, the state activated its crisis standards of care, which provide triage guidelines if absolute scarcity arises.

Arizona has done the right thing by adopting crisis standards of care instead of leaving these decisions about ventilators to be made ad hoc by medical staff, which presents the risk both of arbitrary and biased decisions and of greater distress for clinical staff who are forced to make decisions without a guidance framework.

Arizona’s activation of its crisis standards of care stands in contrast to most other states’ response to the pandemic, including New York, which ultimately did not activate its crisis standards of care. Even though Arizona and other states have not yet reached the stage of absolute scarcity where triage policies are invoked—and hopefully will take steps to avoid reaching it—the move has prompted discussions about fair triage policies and criticisms from some community organizations.

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a stethoscope tied around a dollar bill, with a bottle of pills nearby

What Ever Happened to NIH’s “Fair Pricing” Clause?

By Jorge L. Contreras

In the midst of the COVID-19 pandemic, calls have been made for “fair” and “reasonable” pricing of the vaccines and therapeutics that will eventually be approved to address the virus. A range of proposals in this regard have been made by members of Congress, the Trump Administration, various states, academics and civil society.

Amid this current debate, it is worth remembering the brief period from 1989 to 1995 when the U.S. National Institutes of Health (NIH) did impose reasonable pricing constraints on drugs that were developed as part of cooperative R&D agreements (“CRADAs”) between federal agencies and private industry.

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Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

To Cut Prescription Drug Spending, Stop Delays for Generic Competition

By Beatrice Brown and Benjamin Rome

Prescription drug spending in the U.S. remains high and continues to rise, accounting for about 20% of national health expenditures. While generic competition is crucial for reducing drug prices, brand-name drug manufacturers can utilize several strategies to delay such competition by increasing the length of market exclusivity for their drugs.

Although brand-name drugs only account for 18% of all prescriptions filled, they comprise 78% of total drug spending. By contrast, equally-effective, interchangeable generic drugs can offer discounts of up to 80% off their brand-name drug counterparts.

Generic competitors can only be introduced after brand-name drugs have completed their period of market exclusivity, which typically lasts 12-16 years and is largely determined by the patents covering the drug. Brand-name pharmaceutical manufacturers have strong financial incentives to prolong this market exclusivity period and delay entry of generic products.

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Journal of Law and the Biosciences Continues to Have an Impact

The COVID-19 pandemic has underscored the importance of the biosciences in our world, as well as the legal, ethical, and regulatory choices that shape the development and implementation of innovations from the biosciences.

The Journal of Law and the Biosciences (JLB) offers high-quality, open-access scholarship at the intersection of the biosciences and law as the first fully open-access, peer-reviewed, legal journal to focus on these issues.

Recently, the Journal of Law and the Biosciences received an updated impact factor of 2.275, highlighting its relevance and influence in law, medicine, and ethics. JLB ranks 25th out of 154 law journals, second of sixteen legal medicine journals, and third out of sixteen medical ethics journals.

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