Bioethicists Today: Results of the Views in Bioethics Survey.

Bioethicists influence practices and policies in medicine, science, and public health. However, little is known about bioethicists' views. We recently surveyed 824 U.S. bioethicists on a wide range of ethical issues, including topics related to abortion, medical aid in dying, and resource allocation, among others. We also asked bioethicists about their demographic, religious, academic, and professional backgrounds. We find that bioethicists' normative commitments predict their views on bioethical issues. We also find that, in important ways, bioethicists' views do not align with those of the U.S. public: for instance, bioethicists are more likely than members of the public to think abortion is ethically permissible but are less likely to believe compensating organ donors is. Our demographic results indicate the field of bioethics is far less diverse than the U.S. population-less diverse even than other academic disciplines-suggesting far more work needs to be done to build an inclusive field.

Association of Race and Ethnicity With High Longevity Deceased Donor Kidney Transplantation Under the US Kidney Allocation System.

RATIONALE & OBJECTIVE: The US Kidney Allocation System (KAS) prioritizes candidates with ≤20% Estimated Post-Transplant Survival (EPTS) for high longevity kidneys defined by a ≤20% Kidney Donor Profile Index (KDPI). Use of EPTS in the KAS deprioritizes candidates with older age, diabetes, and longer dialysis durations. We assessed whether this use also disadvantages racial-ethnic minority candidates, who are younger but more likely to have diabetes and longer durations of kidney failure requiring dialysis. STUDY DESIGN: Observational cohort study. SETTING: & Participants: Adult candidates for and recipients of kidney transplantation represented in the Scientific Registry of Transplant Recipients from January 2015 through December 2020. EXPOSURE: Race and ethnicity. OUTCOMES: Age-adjusted assignment to ≤20% EPTS, transplantation of a ≤20% KDPI kidney, and post-transplant survival in longevity matched recipients by racial-ethnicity. ANALYTIC APPROACH: Multivariable logistic regression, Fine-Gray competing risks survival analysis, and Kaplan-Meier and Cox Proportional Hazards methods. RESULTS: The cohort included 199,444 candidates (7% Asian, 29% Black, 19% Hispanic/Latino, 43% White) listed for deceased donor kidney transplantation. Non-White candidates had significantly higher rates of diabetes, longer dialysis duration, and were younger than White candidates. Adjusted for age, Asian, Black, and Hispanic/Latino candidates had significantly lower odds of having a ETPS score ≤20% (OR 0.86, [0.81, 0.91], 0.52 [0.50, 0.54], and 0.49, [0.47, 0.51]), and were less likely to receive a ≤20% KDPI kidney (subHR 0.70 [0.66, 0.75], 0.89 [0.87, 0.92], and 0.73 [0.71, 0.76]), compared to White candidates. Among recipients with ≤20% EPTS scores transplanted with a ≤20% KDPI deceased donor kidney, Asian and Hispanic recipients had lower post-transplant mortality (HR 0.45 [0.27, 0.77], and 0.63 [0.47, 0.86]) and Black recipients had higher but not statistically significant post-transplant mortality (HR 1.22 [0.99, 1.52]) compared to White recipients. LIMITATIONS: Provider reported race-ethnicity data and 5-year post transplant follow-up period. CONCLUSIONS: The US kidney allocation system is less likely to identify racial-ethnic minority candidates as having a ≤20% EPTS score which triggers allocation of high longevity deceased donor kidneys. These findings should inform the OPTN about how to remedy racial/ethnic disparities introduced through KAS's current approach of allocating allografts with longer predicted longevity to recipients with longer estimated post-transplant survival.

The importance of getting the ethics right in a pandemic treaty.

The COVID-19 pandemic revealed numerous weaknesses in pandemic preparedness and response, including underfunding, inadequate surveillance, and inequitable distribution of countermeasures. To overcome these weaknesses for future pandemics, WHO released a zero draft of a pandemic treaty in February, 2023, and subsequently a revised bureau's text in May, 2023. COVID-19 made clear that pandemic prevention, preparedness, and response reflect choices and value judgements. These decisions are therefore not a purely scientific or technical exercise, but are fundamentally grounded in ethics. The latest treaty draft reflects these ethical considerations by including a section entitled Guiding Principles and Approaches. Most of these principles are ethical-they establish core values that undergird the treaty. Unfortunately, the treaty draft's set of principles are numerous, overlapping, and show inadequate coherence and consistency. We propose two improvements to this section of the draft pandemic treaty. First, key guiding ethical principles should be clearer and more precise than they currently are. Second, the link between ethical principles and policy implementation should be clearly established and define boundaries on acceptable interpretation, ensuring that signatories abide by these principles.

Equitable global allocation of monkeypox vaccines.

With the world grappling with continued spread of monkeypox internationally, vaccines play a crucial role in mitigating the harms from infection and preventing spread. However, countries with the greatest need - particularly historically endemic countries with the highest monkeypox case-fatality rates - are not able to acquire scarce vaccines. This is unjust, and requires rectification through equitable allocation of vaccines globally. We propose applying the Fair Priority Model for such allocation, which emphasizes three key principles: 1) preventing harm; 2) prioritizing the disadvantaged; and 3) treating people with equal moral concern. Post-exposure prophylaxis (PEPV) has the most potential to mitigate harm, and so ensuring countries have sufficient supply for PEPV should be the first priority. And historically endemic countries, which face disadvantages that compound potential harms from monkeypox, should be the first recipients of such vaccines. Once sufficient supply is allocated for countries to apply PEPV, global allocation could move on to pre-exposure prophylaxis (PrEP), again prioritizing historically endemic countries first before distribution to the rest of the global community, based on projected number of cases and vulnerability to harm.

The shared ethical framework to allocate scarce medical resources: a lesson from COVID-19.

The COVID-19 pandemic has helped to clarify the fair and equitable allocation of scarce medical resources, both within and among countries. The ethical allocation of such resources entails a three-step process: (1) elucidating the fundamental ethical values for allocation, (2) using these values to delineate priority tiers for scarce resources, and (3) implementing the prioritisation to faithfully realise the fundamental values. Myriad reports and assessments have elucidated five core substantive values for ethical allocation: maximising benefits and minimising harms, mitigating unfair disadvantage, equal moral concern, reciprocity, and instrumental value. These values are universal. None of the values are sufficient alone, and their relative weight and application will vary by context. In addition, there are procedural principles such as transparency, engagement, and evidence-responsiveness. Prioritising instrumental value and minimising harms during the COVID-19 pandemic led to widespread agreement on priority tiers to include health-care workers, first responders, people living in congregate housing, and people with an increased risk of death, such as older adults and individuals with medical conditions. However, the pandemic also revealed problems with the implementation of these values and priority tiers, such as allocation on the basis of population rather than COVID-19 burden, and passive allocation that exacerbated disparities by requiring recipients to spend time booking and travelling to appointments. This ethical framework should be the starting point for the allocation of scarce medical resources in future pandemics and other public health conditions. For instance, allocation of the new malaria vaccine among sub-Saharan African countries should be based not on reciprocity to countries that participated in research, but on maximally reducing serious illness and deaths, especially among infants and children.

What Does Dobbs v. Jackson Mean for Oncology Patients and Providers? Current Considerations for Pregnancy and Fertility in the Oncology Setting.

The incidence of cancers such as colorectal cancer, head and neck cancer, and melanoma has increased in younger patients. The number of cancer survivors is also increasing in the US. Pairing these facts together, there are many people with cancer for whom pregnancy and fertility concerns are crucial aspects of their oncologic and survivorship care. For these patients, understanding and having access to fertility preservation options is an essential part of their care. At JADPRO Live 2022, a panel of experts from diverse professions provided perspectives on the consequences for the treatment landscape after the Dobbs v. Jackson decision.

Fair domestic allocation of monkeypox virus countermeasures.

Countermeasures for mpox (formerly known as monkeypox), primarily vaccines, have been in limited supply in many countries during outbreaks. Equitable allocation of scarce resources during public health emergencies is a complex challenge. Identifying the objectives and core values for the allocation of mpox countermeasures, using those values to provide guidance for priority groups and prioritisation tiers, and optimising allocation implementation are important. The fundamental values for the allocation of mpox countermeasures are: preventing death and illness; reducing the association between death or illness and unjust disparities; prioritising those who prevent harm or mitigate disparities; recognising contributions to combating an outbreak; and treating similar individuals similarly. Ethically and equitably marshalling available countermeasures requires articulating these fundamental objectives, identifying priority tiers, and recognising trade-offs between prioritising the people at the highest risk of infection and the people at the highest risk of harm if infected. These five values can provide guidance on preferable priority categories for a more ethically sound response and suggest methods for optimising allocation of countermeasures for mpox and other diseases for which countermeasures are in short supply. Properly marshalling available countermeasures will be crucial for future effective and equitable national responses to outbreaks.

Dose optimisation and scarce resource allocation: two sides of the same coin.

OBJECTIVE: A deep understanding of the relationship between a scarce drug's dose and clinical response is necessary to appropriately distribute a supply-constrained drug along these lines. SUMMARY OF KEY DATA: The vast majority of drug development and repurposing during the COVID-19 pandemic - an event that has made clear the ever-present scarcity in healthcare systems -has been ignorant of scarcity and dose optimisation's ability to help address it. CONCLUSIONS: Future pandemic clinical trials systems should obtain dose optimisation data, as these appear necessary to enable appropriate scarce resource allocation according to societal values.

Errors in Converting Principles to Protocols: Where the Bioethics of U.S. Covid-19 Vaccine Allocation Went Wrong.

For much of 2021, allocating the scarce supply of Covid-19 vaccines was the world's most pressing bioethical challenge, and similar challenges may recur for novel therapies and future vaccines. In the United States, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) identified three fundamental ethical principles to guide the process: maximize benefits, promote justice, and mitigate health inequities. We argue that critical components of the recommended protocol were internally inconsistent with these principles. Specifically, the ACIP violated its principles by recommending overly broad health care worker priority in phase 1a, using being at least seventy-five years of age as the only criterion to identify individuals at high risk of death from Covid-19 during phase 1b, failing to recommend place-based vaccine distribution, and implicitly endorsing first-come, first-served allocation. More rigorous empirical work and the development of a complete ethical framework that recognizes trade-offs between principles may have prevented these mistakes and saved lives.

Race-Specific, State-Specific COVID-19 Vaccination Rates Adjusted for Age.

The authors provide the first age-standardized race/ethnicity-specific, state-specific vaccination rates for the United States. Data encompass all states reporting race/ethnicity-specific vaccinations and reflect vaccinations through mid-October 2021, just before eligibility expanded below age 12. Using indirect age standardization, the authors compare racial/ethnic state vaccination rates with national rates. The results show that white and Black state median vaccination rates are, respectively, 89 percent and 76 percent of what would be predicted on the basis of age; Hispanic and Native rates are almost identical to what would be predicted; and Asian American/Pacific Islander rates are 110 percent of what would be predicted. The authors also find that racial/ethnic vaccination rates are associated with state politics, as proxied by 2020 Trump vote share: for each percentage point increase in Trump vote share, vaccination rates decline by 1.08 percent of what would be predicted on the basis of age. This decline is sharpest for Native American vaccinations, although these are reported for relatively few states.

Off-Label Prescription of COVID-19 Vaccines in Children: Clinical, Ethical, and Legal Issues.

The US Food and Drug Administration (FDA) approval of the biologics license application for the Pfizer-BioNTech coronavirus disease 2019 vaccine (Comirnaty) on August 23, 2021, opened the door to the off-label vaccination of children younger than the age range currently covered by either the biologics license application (16 years old and older) or the emergency use authorization (12 to 15 years old). Although prescribing medications at doses, for conditions, or in populations other than those approved by the FDA is generally legal and is common in pediatrics, the FDA, the Centers for Disease Control and Prevention, and the American Academy of Pediatrics have recommended against off-label prescription of the coronavirus disease 2019 vaccine. Several commentaries consider a case in which parents ask their child's pediatrician to prescribe the vaccine for their 11-year-old with special health care needs before approval or authorization in her age group. The first commentary considers the potential benefits and risks to the patient, as well as to the family, the provider, and society, emphasizing the unknown risks in younger patients and the need for adequate informed consent. The second commentary describes an algorithm and principles for evaluating off-label prescribing and argues that the current benefits of prescribing Comirnaty off label to children <12 do not outweigh the risks. The third commentary addresses ethical and legal issues, ultimately calling on federal agencies to remove legal barriers to making the vaccine available to children in age groups that currently lack authorization.

Fair Allocation of Scarce Therapies for Coronavirus Disease 2019 (COVID-19).

The US Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for monoclonal antibodies (mAbs) for nonhospitalized patients with mild or moderate coronavirus disease 2019 (COVID-19) disease and for individuals exposed to COVID-19 as postexposure prophylaxis. EUAs for oral antiviral drugs have also been issued. Due to increased demand because of the Delta variant, the federal government resumed control over the supply and asked states to ration doses. As future variants (eg, the Omicron variant) emerge, further rationing may be required. We identify relevant ethical principles (ie, benefiting people and preventing harm, equal concern, and mitigating health inequities) and priority groups for access to therapies based on an integrated approach to population health and medical factors (eg, urgently scarce healthcare workers, persons in disadvantaged communities hard hit by COVID-19). Using priority categories to allocate scarce therapies effectively operationalizes important ethical values. This strategy is preferable to the current approach of categorical exclusion or inclusion rules based on vaccination, immunocompromise status, or older age, or the ad hoc consideration of clinical risk factors.