an ambulance parked at the entrance of an emergency department

Racial Disparities Persist in Human Subjects Research

By Beatrice Brown

Human subjects research has long been plagued by racial inequality. While flagrant abuses have been curtailed, disparities have, unfortunately, persisted.

One area ripe for scrutiny is clinical trial enrollment. A 2018 study by William Feldman, Spencer Hey, and Aaron Kesselheim in Health Affairs documents racial disparities in trials that are exempt from typical requirements for informed consent from study participants.

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Researcher works at a lab bench

New Study Provides Insights into Potential Regulatory Treatment of COVID-19 Drugs

By Beatrice Brown

As the global pandemic continues, trials have been established to test whether existing drugs such as hydroxychloroquine could be repurposed to treat patients with COVID-19. There are also hopes that a novel drug will surface. But questions remain about when treatments and vaccines will become available.

There is currently great optimism that a treatment or vaccine will be developed quickly, but there is no assurance that such a vaccine or treatment will be highly effective or that normalcy will return in any particular timeframe. A recent study published in the Lancet ID by Jonathan J. Darrow, Mehdi Najafzadeh, Kristina Stefanini, and Aaron S. Kesselheim provides data that might help to temper enthusiasm with evidence.

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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.

Safer at Home? Yes, but Not According to the Wisconsin Supreme Court

By Beatrice Brown, Jane Cooper, and Danielle Pacia

Due to the Bill of Health production schedule, this piece is being published two weeks after it was written, on May 20th, 2020. The authors would like to affirm the importance of protests against anti-Black racism in America.

Stay-at-home orders—the primary means of managing the COVID-19 pandemic in the U.S.—face increasing opposition as protestors against these public health measures clamor for a “return to normal.” In Wisconsin, pushback against stay-at-home orders culminated in the state Supreme Court’s decision on May 13 to reverse the state’s “Safer at Home” policy.

Republican leaders of the state legislature filed suit against state Department of Health Services Secretary-designee Andrea Palm and other health officials, resulting in the case Wisconsin Legislature v. Palm. In a 4-3 ruling, the Wisconsin Supreme Court held that the “Safer at Home” order was “unlawful” and “unenforceable.”  Read More

WASHINGTON MAY 21: Pro-choice activists rally to stop states’ abortion bans in front of the Supreme Court in Washington, DC on May 21, 2019.

The Harms of Abortion Restrictions During the COVID-19 Pandemic

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.

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mask, gloves, goggles.

Are Clinicians Without PPE Morally Obligated to Care for COVID-19 Patients?

By Beatrice Brown

There is currently a dire shortage of personal protective equipment (PPE) at hospitals across the United States, especially in areas that have been hit the hardest by COVID-19.

PPE is essential to protecting those on the front lines of the pandemic – the President of the American Medical Association (AMA) has said that without adequate PPE, we may face a shortage of clinicians to treat COVID-19 patients, in addition to other shortages of critical resources.

Without adequate PPE, are clinicians morally obligated to provide care to patients who are either presumed positive for COVID-19 or who definitely have the virus?

Here, I argue that to treat patients without adequate PPE is supererogatory but not obligatory. In other words, this is a noble and praiseworthy act, but clinicians should not be obligated to perform these heroic acts, nor should we blame them, morally, for their decision to refuse to provide care.

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hospital equipment, including heart rate monitor and oxygen monitor functioning at bedside.

The Ethical Allocation of Scarce Resources in the US During the COVID-19 Pandemic: The Role of Bioethics

By Beatrice Brown

Critical resources for handling the COVID-19 pandemic, including ventilators and ICU beds, are quickly becoming scarce in the US as the number and density of infections continue to rise. Leading bioethicists have crafted guidelines for the ethical rationing of these scarce resources during the pandemic. On March 16, The Hastings Center published “Ethical Framework for Health Care Institutions and Guidelines for Institutional Ethics Services Responding to the Novel Coronavirus Pandemic,” detailing three ethical duties for health care leaders: 1) duty to plan; 2) duty to safeguard; and 3) duty to guide. The report also contains a compilation of materials on resource and ventilator allocation.

More recently, on March 23, two insightful pieces were published in the New England Journal of Medicine: “The Toughest Triage — Allocating Ventilators in a Pandemic” by Truog, Mitchell, and Daley, and “Fair Allocation of Scarce Medical Resources in the Time of Covid-19” by Emanuel et al. These two pieces complement each other well and lay a crucial foundation for the inevitable resource allocation that clinicians and hospitals will be forced to practice in the coming weeks. As such, here, I summarize the central takeaways from these two articles while understanding their recommendations in tandem, as well as reflect on the importance of bioethics during these times of medical crisis and how the work of this field must adapt to changing circumstances. Read More

Vials of medications with syringe and needle.

Is “Implied Consent” Ethically Permissible in WHO’s Malaria Vaccine Pilot Introduction?

By Beatrice Brown

A recent BMJ article has exposed ethical concerns with the informed consent process in the World Health Organization’s (WHO) large, randomized cluster trial of the world’s first licensed malaria vaccine, RTS,S, known as Mosquirix. The study is being conducted in Malawi, Ghana, and Kenya, and 720,000 children will receive the vaccine. The vaccine is currently limited to pilot implementation because of residual safety concerns from previous clinical trials, including: a tenfold rate of meningitis in those who received the vaccine versus those who did not, “increased cerebral malaria cases, and a doubling in the risk of death in girls.” Rather than engaging in the traditional informed consent process, the WHO is utilizing an implied consent process, leading several bioethicists, including Charles Weijer, Christine Stabell Benn, and Jonathan Kimmelman, to voice concern.

The WHO has defended their use of implied consent to BMJ on the grounds that “the study is a ‘pilot introduction’ and not a ‘research activity.'” A WHO spokesperson explained that in an implied consent process, “parents are informed of imminent vaccination through social mobilisation and communication, sometimes including letters directly addressed to parents. Subsequently, the physical presence of the child or adolescent, with or without an accompanying parent at the vaccination session, is considered to imply consent.” However, as Weijer rightly points out, this is not truly consent, as “We have no assurance that parents, in fact, received information about the study let alone that they understood it.” After the publication of the original article criticizing the WHO for going against international ethical standards for research involving human participants, the WHO released a response in BMJ and on their own website, contending that this implied consent process is “used for all vaccines provided through the Expanded Programme on Immunization” and that the study is in accordance with international ethical standards. Here, I further explore whether this implied consent process is ethically permissible in this specific trial by exploring the guidelines set out by two organizations.

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Empty hospital food tray with plate and glass

The Ethics of Dementia Advance Directives for Receiving Oral Food and Water

By Beatrice Brown

Last month, Kaiser Health News (KHN) told the story of Susan Saran, a woman diagnosed with frontotemporal dementia. According to KHN, Saran consulted a lawyer and signed an advance directive for dementia after experiencing two brain hemorrhages in 2018. The document directs caregivers to withhold hand feeding and fluids at the end of life for those with advanced dementia. However, her continuing care retirement community told her that they could not honor her wishes because “the center is required by state and federal law to offer regular daily meals, with feeding assistance if necessary.” As noted by Dr. Stanley Terman, “Even when people document their choices – while they still have the ability to do so – there’s no guarantee those instructions will be honored.”

According to KHN, these dementia advance directives are “a controversial form” of voluntarily stopping eating and drinking (VSED), wherein a terminally ill patient who still retains mental capacity refuses food and water to hasten their death. VSED is considered by many to be a morally acceptable extension of a patient’s right to refuse treatment, a right codified in the landmark cases of Karen Ann Quinlan and Nancy Cruzan. The ethical question here, then, is whether the refusal of hand feeding and fluids requested in dementia advance directives is another form of VSED and is thus morally permissible, or if this refusal is ethically distinct from VSED and is perhaps morally prohibited. Read More

Surrealist black and white photograph of a person wearing a bowler hat and button down shirt. Ther person's face is obscured totally by a tiny cloud

DNA Phenotyping Experiment on Uighurs Raises Ethical Questions About Informed Consent

By Beatrice Brown

On December 3, The New York Times broke shocking news: China has been using the DNA of Uighurs, a Muslim minority group who have been facing increased persecution, to create an image of a person’s face using a process called DNA phenotyping. The Uighur men were living in Tumxuk (a city in the Xinjiang region), which The New York Times notes being described by Chinese state news media as “one of the gateways and major battlefields for Xinjiang’s security work.” The New York Times introduced many troubling ethical issues, including the potential for increased social surveillance and thus increased “state discrimination” of this vulnerable ethnic minority, but here, I wish to focus on the issue of informed consent.

Informed consent is essential to conducting ethical research. Premised on respecting the autonomy of participants, informed consent requires that participants understand the research that they are consenting to be involved in, including potential risks and benefits of the research. However, what exactly constitutes true, valid informed consent to research is a contentious issue. There are two concerns about the validity of the informed consent process in this DNA phenotyping experiment. Read More

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