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Background: High educational attainment may protect individuals, particularly middle-aged and older adults, against a wide range of health risks, including memory decline with age; however, this protection is less clear in patients with Alzheimer's disease (AD). In addition, this effect may differ across racial groups. According to the Marginalized-Related Diminished Return (MDR) theory, for example, the protective effect of high educational attainment on mental and physical health shows a weaker protective effect for racial minority groups, particularly Black people compared to White individuals., Objectives: This longitudinal study used data of middle-aged and older adults with AD with two aims: first, to test the association between educational attainment and memory, and second, to explore racial differences in this association in the USA., Methods: Data came from the Alzheimer's Disease Neuroimaging Initiative (ADNI) study. The total sample was 1673 American middle-aged and older adults. The independent variable was educational attainment measured as years of education. The main outcome was memory operationalized as Rey Auditory Verbal Learning Test (RAVLT) Verbal Forgetting percentage (VF%). Age, gender, and follow-up duration were covariates. Race was the effect modifier. Linear regression model was utilized to analyze the data., Results: Of all participants, 68 (4.1%) were Black, and the remaining were White, with a mean age of 75 years old. In the pooled sample, educational attainment did not show a significant association with memory, independent of confounders. Educational attainment showed a significant interaction with race on memory, with higher educational attainment having a different effect on memory in White patients compared to Black patients., Conclusion: The effect of higher educational attainment on memory differs for Black patients with AD compared to White patients. To prevent cognitive disparities by race, we need to go beyond racial inequality in access to resources (e.g., education) and minimize diminished returns of educational attainment for racial minorities. To tackle health inequalities, social policies should not be limited to equalizing socioeconomic status but also help minority groups leverage their available resources, such as educational attainment, and secure tangible outcomes., (© 2022. W. Montague Cobb-NMA Health Institute.)

Objective: To estimate the prevalence of dementia among American Indian and Alaska Native (AIAN) Medicare beneficiaries and compare the prevalence of dementia in AIANs and other racial and ethnic minority groups-non-Hispanic Blacks (NHBs) and Hispanics-with non-Hispanic Whites (NHWs) Medicare beneficiaries., Methods: We used survey data from Round 5 of the National Health and Aging Trends Study (NHATS, 2015) (N = 7,449), a nationally representative study of Medicare beneficiaries ages 65 years and older. We used logistic regression to estimate the age- and sex-adjusted prevalence of dementia with 95% confidence intervals by race/ethnicity as well as prevalence differences between groups., Results: The majority of participants were between 65 and 74 years old. Approximately half of them were female. NHWs had a prevalence of 5% for dementia, and AIAIs had a prevalence of 9%, four percentage points higher than NHWs (95%CI 1%, 11%). We estimated a similar difference in the prevalence of dementia in AIAN Medicare beneficiaries compared to NHBs., Conclusion: While previous research has reported that AIANs share a similar or lower prevalence of dementia than NHWs, our findings suggest a potentially higher prevalence of dementia among AIAN Medicare beneficiaries. A relatively small number of AIAN resulted in wide confidence intervals for many of our associations. Future research should focus on recruiting a larger sample and on dementia prevalence and unique risk factors within and among AIAN tribes., (© 2022. W. Montague Cobb-NMA Health Institute.)

During the last few years, the pharmaceutical industry has adopted digital technologies/digital health technology (DHT) to improve the drug development process and the commercialization of new products. Technological advances are strongly supported by both the US-FDA and the EMA, but the regulatory landscape in the US seems to be more suitable to promote innovation in the digital health sector (e.g. Cures Act). In contrast, the new Medical Device Regulation sets high hurdles for Medical Device software to pass regulatory scrutiny.On both sides of the Atlantic, a digital tool must be fit-for-purpose for the intended use in the clinical drug trial. Irrespective of its status as a Medical Device, at least the basic safety and performance requirements according to local regulations should be met, quality system and surveillance requirements should be fulfilled, and the sponsor must ensure conformity with GxP and the local data privacy and cybersecurity legislations.There is an overlap in technical and clinical validation for drug development tool qualification in both regions to ensure that the digital tools deliver reliable data with tangible clinical benefits. Based on an analysis of the regulatory framework of the FDA and the EMA, this study proposes regulatory strategies for a global pharma company: It would be prudent for drug development companies to a) use approved solutions or b) consider qualification of drug development tools early and in parallel to clinical development. Early engagement with the FDA and the EMA/CA is recommended to define evidentiary standards and corresponding regulatory pathways for different contexts-of-use and to clarify regulator's expectations as to what extent data collected by digital tools are acceptable to support marketing authorization applications (MAA).Hence a harmonization of the partly disparate regulatory requirements in the US and the EU accompanied by further development of the regulatory landscape in the EU, could further foster the use of digital tools in drug clinical development. The outlook for the use of digital tools in clinical trials is hopeful., (© 2023. The Author(s), under exclusive licence to The Drug Information Association, Inc.)

Background: The COVID-19 pandemic disproportionately affected minorities in population rates of infection, hospitalization, and mortality. However, little is known about the broader racial disparities in fears and perceptions about the pandemic and getting treated., Objective: To examine disparities in perceived risks of COVID-19 and getting medical care., Methods: Using the nationally representative Stanford University School of Medicine Coronavirus Attitudes and Behaviors Survey fielded in May of 2020, we examine racial and ethnic disparities in eight measures on the perceived risks of COVID-19. We use regression analysis to risk adjust perceptions controlling for 10 socioeconomic, demographic, and health variables., Results: Black respondents were 15 percentage points more likely than White respondents to believe the pandemic would not end by Summer 2020 (92% vs 77%, p < .01), and were 19 percentage points more likely than any other race to feel a need to protect their family from COVID-19 (81% vs 62%, p < .01). Latinx respondents were 10 percentage points more fearful than White respondents of catching COVID-19 in public places (55% vs 45%, p < 0.01). Black respondents were 20 percentage points more likely than White respondents to think they would need medical care if infected (71% vs 51%, p < .01), and 18 percentage points more likely to think they would need to be hospitalized (59% vs 41%, p < .01). The proportion of Black respondents believing that the hospital would not have enough capacity to treat them if infected with COVID-19 was 12 percentage points higher than White respondents (41% vs 29%, p < 0.05)., Conclusion: Disparities in the COVID-19-related perceived risks and mistrust in healthcare across racial and ethnic groups existed at the beginning of the COVID-19 pandemic. As we enter into a post-COVID New Normal, new policies must ensure that the causes of this widespread fear and distrust in the healthcare system are understood and reversed., (© 2021. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.)

The SARS-CoV-2 infection, which causes the coronavirus disease (COVID-19), has affected lives, with very adverse outcomes in specific populations in the United States of America (USA), a high-income country, and two middle-income countries, Brazil and South Africa. This paper aims to discuss the relationship of race/ethnicity with COVID-19-associated factors in the three countries. The information is based on data collected from infectious disease/epidemiological centers in the USA, Brazil, and South Africa. Adverse COVID-19 outcomes have been associated with the burden of exposure and disease, linked to socioeconomic determinants, among specific ethnicities in all three countries. The prevalence of comorbidities before and the likelihood of work-related exposure in the context of COVID-19 infection puts ethnic minorities in the USA and some ethnic majorities and minorities in Brazil and South Africa at greater risk. We envisage that this work will contribute to ongoing discussions related to addressing socioeconomic determinants of health, and the need for stakeholders in various sectors to work on addressing observed health disparities for overall improvement in health and healthcare given the current pandemic., (© 2021. W. Montague Cobb-NMA Health Institute.)

Background: Racially and ethnically marginalized US women experience unintended pregnancy at twice the rate of White women. Understanding contraceptive attitudes can help identify women at increased risk of contraceptive non-use and unintended pregnancy. We assessed the contraceptive attitudes of US-born and foreign-born Black women and examined differences by nativity., Methods: We used an electronic survey, implemented by Lucid LLC, a consumer research firm, to collect cross-sectional data from 657 reproductive-aged women. Analysis was limited to 414 Black women aged 18-44 years. The exposure variable was nativity (US-born or foreign-born), and the outcome variable was cumulative score on the 32-item Contraceptive Attitude Scale (CAS). Analysis included multivariable linear regression, adjusted for confounders. We also estimated separate models, stratified by nativity to identify predictors of contraceptive attitude among US-born Black women and foreign-born Black women, respectively., Results: Three in four participants were US-born (76.6%). The average cumulative CAS score was 118.4 ±20.4 out of 160 indicating favorable contraceptive attitudes. In pooled analysis, foreign-born Black women had significantly lower contraceptive attitude scores compared to US-born women (adjusted regression coefficient (β)= -6.48, p=0.036). In nativity-stratified analysis, income, education, and perceived control over pregnancy timing were significant predictors of contraceptive attitudes for both US-born and foreign-born women. Other significant predictors of contraceptive attitude among US-born women were older maternal age, multi-parity, and perceived pregnancy risk; whereas, for foreign-born women, other significant predictors included marital status (married/cohabiting), language spoken predominantly at home (French), and perceived ability to have a baby and still achieve life goals (agree, neither agree nor disagree)., Conclusion: In addressing the contraceptive needs of Black women, it is important to recognize the differences in attitudes towards contraception by nativity and provide culturally sensitive information and education., (© 2023. W. Montague Cobb-NMA Health Institute.)

Strikingly ignoring the critical impact of systemic racism in vulnerabilities to the deadly coronavirus, phase one of the vaccine rollout is not reaching the Black population that has suffered the most from COVID. An urgent need exists for a race-conscious approach that ensures equitable opportunities to both access and receive the vaccines., (© 2021. W. Montague Cobb-NMA Health Institute.)

A well-preserved oral function is key to accomplishing essential daily tasks. However, in geriatric medicine and gerodontology, as age-related physiological decline disrupts several biological systems pathways, achieving this objective may pose a challenge. We aimed to make a systematic review of the existing literature on the relationships between poor oral health indicators contributing to the oral frailty phenotype, defined as an age-related gradual loss of oral function together with a decline in cognitive and physical functions, and a cluster of major adverse health-related outcomes in older age, including mortality, physical frailty, functional disability, quality of life, hospitalization, and falls. Six different electronic databases were consulted by two independent researchers, who found 68 eligible studies published from database inception to September 10, 2022. The risk of bias was evaluated using the National Institutes of Health Quality Assessment Toolkits for Observational Cohort and Cross-Sectional Studies. The study is registered on PROSPERO (CRD42021241075). Eleven different indicators of oral health were found to be related to adverse outcomes, which we grouped into four different categories: oral health status deterioration; decline in oral motor skills; chewing, swallowing, and saliva disorders; and oral pain. Oral health status deterioration, mostly number of teeth, was most frequently associated with all six adverse health-related outcomes, followed by chewing, swallowing, and saliva disorders associated with mortality, physical frailty, functional disability, hospitalization, and falls, then decline in oral motor skills associated with mortality, physical frailty, functional disability, hospitalization, and quality of life, and finally oral pain was associated only with physical frailty. The present findings could help to assess the contribution of each oral health indicator to the development of major adverse health-related outcomes in older age. These have important implications for prevention, given the potential reversibility of all these factors., (© 2022. The Author(s), under exclusive licence to American Aging Association.)

Publication in leading medical journals is critical to knowledge dissemination and academic advancement alike. Leveraging a novel dataset comprised of nearly all articles published in JAMA and NEJM from 1990 to 2020, along with established reference works for name identification, we explore changing authorship demographics in two of the world's leading medical journals. Our main outcomes are the annual proportion of male and female authors and the proportion of racial/ethnic identities in junior and senior authorship positions for articles published in JAMA and NEJM since 1990. We found that women remain under-represented in research authorship in both JAMA (at its peak, 38.1% of articles had a female first author in 2011) and NEJM (peaking at 28.2% in 2002). The rate of increase is so slow that it will take more than a century for both journals to reach gender parity. Black and Hispanic researchers have likewise remained under-represented as first and last authors in both journals, even using the best-case scenario. Their appearance as authors has remained stagnant for three decades, despite attention to structural inequalities in medical academia. Thus, analysis of authorship demographics in JAMA and NEJM over the past three decades reveals the existence of inequalities in high-impact medical journal authorship. Gender and racial/ethnic disparities in authorship may both reflect and further contribute to disparities in academic advancement., (© 2022. W. Montague Cobb-NMA Health Institute.)

Importance: Law enforcement activity, in the form of outside agencies or hospital security forces, is increasingly common in American healthcare. Little is known about the potential effects of this prevalent, modifiable exposure on hospital staff and patient health. This narrative review characterizes existing evidence on the direct and indirect health effects of law enforcement activity in hospitals., Observations: Law enforcement activity in hospitals can affect health outcomes through four mechanisms: (1) physical health effects related to workplace violence, restraint use, excessive force, and weapon use; (2) mental health effects involving perceptions of safety and psychological distress; (3) social effects related to the patient-provider relationship, mistrust, and bias and discrimination; and (4) legal and ethical considerations affecting overall well-being., Conclusions and Relevance: Unchecked law enforcement activity in hospitals may risk patient physical and mental health, reduce patient trust, result in bias and discrimination, and contribute to legal and ethical rights violations. Importantly, law enforcement activity in hospitals may also contribute to staff perceptions of safety. To fill knowledge gaps on the measurable impact of law enforcement activity in the hospital on staff and patients, hospitals should collect and publicly share robust data on law enforcement activity in their facilities, create and adopt patient-centered policies to ensure safety and protect patient health and privacy, and implement evidence-based interventions that safely reduce law enforcement involvement with patients., (© 2022. W. Montague Cobb-NMA Health Institute.)

Federally Qualified Community Health Centers (FQHCs), serving Health Professional Shortage Areas (HPSAs), are fixtures of the healthcare safety net and are central to healthcare delivery for African Americans and other marginalized Americans. Anti-African American bias, tied to anti- "welfare" sentiment and to a belief in African Americans' supposed safety net dependency, can suppress states' willingness to identify HPSAs and to apply for and operate FQHCs. Drawing on data from n = 1,084,553 non-Hispanic White Project Implicit respondents from 2013-2018, we investigated associations between state-level implicit and explicit racial bias and availability of FQHCs and with HPSA designations. After controlling for states' sociopolitical conservatism, wealth, health status, and acceptance of the Affordable Care Act's Medicaid expansion, greater racial bias was correlated with fewer FQHC delivery sites and fewer HPSA designations. White's bias against African Americans is associated with fewer FQHC opportunities for care and fewer identifications of treatment need for African Americans and other low-income people lacking healthcare options, reflecting bias-influenced neglect., (© 2022. The Author(s).)

Background: Prescription opioid misuse (POM) is an important public health concern. Not many studies have evaluated factors influencing racial and ethnic differences in POM exclusively in young adolescents. We evaluated factors influencing the racial and ethnic differences in POM in a nationally representative sample of 8th- and 10th-grade (12-15 years old) US adolescents., Methods: Data were from 107,786 adolescents who participated in the 2009-2019 Monitoring the Future survey. Logistic regression and mediation analysis were used to identify risk factors for POM and evaluate mediators of the association of race and ethnicity on the frequency of POM in the past year., Results: From 2009 to 2019, the prevalence of POM in the past year decreased from 3.2% to 1.8% (p = 0.032), with significant differences in POM trends by race and ethnicity. Overall, the prevalence was higher among non-Hispanic White adolescents (3.2%) than Hispanic (2.5%) and non-Hispanic Black adolescents (1.6%), p < 0.001. After adjustment for demographic, substance use, lifestyle, and family-related factors, the odds of POM were lower among Black (odds ratio (OR) = 0.81, 95% confidence interval (CI): 0.66-0.98) and Hispanic adolescents (OR = 0.64, CI: 0.55-0.74) compared to White adolescents. Illicit drug use and misuse of other prescription drugs together explained 77.2% and 47.3% of the racial and ethnic disparities in POM among Black and Hispanic adolescents, respectively., Conclusion: In this study, significant racial and ethnic differences in the trends of POM were observed. Illicit drug use and misuse of other prescription drugs substantially explained the racial and ethnic disparities in POM among young adolescents., (© 2021. W. Montague Cobb-NMA Health Institute.)

Background: Digital therapeutics (DTx), the provision of treatment through mobile devices such as smartphones, have attracted great interest as a new medical modality. However, the number of authorized therapeutic applications in the US and Japan is low. Understanding the obstacles in obtaining regulatory authorizations will be the key in promoting timely development of therapeutic applications. Thus, we conducted a comprehensive analysis of the clinical study designs of therapeutic applications authorized in the US and Japan., Methods: Data on authorized therapeutic applications and the regulations involved were collated from the databases of the Food and Drug Administration (USA), Ministry of Health, Labour and Welfare (Japan), and Pharmaceuticals and Medical Devices Agency (Japan)., Results: Most therapeutic applications authorized targeted neuropsychiatric disorders and used cognitive behavioral therapy (CBT)-based treatments. All the involved clinical trials were randomized-controlled studies. Various types of controls-such as standard care, sham application, digital control, and therapies delivered by healthcare providers-were used. Both subjective and objective indices were acceptable as the primary endpoints. Long-term efficacy was evaluated, and all adverse events were assessed comprehensively. The setting up of controls and the need to study long-term efficacy depend heavily on the applications functionality and the target disease characteristics., Conclusions: This study reveals the points to be considered in planning clinical studies and regulatory strategies for authorizing therapeutic applications. Therapeutic applications can provide new therapy and have potential to solve unmet clinical needs. Our findings shed a light on efficient development and rapid commercialization of therapeutic applications., (© 2022. The Author(s).)

Background: The threat of a deadly pandemic, racial tension, recessionary economic circumstances, and educational disruption likely contributed to the heightened anxiety felt by many Americans in 2020. This study examines the differential anxiety experienced by Black, White, and Hispanic households with and without children during 2020., Method: Data from the Census Bureau's Household Pulse Survey detailing the frequency of anxiety among a nationally representative sample of adults from April 23 to December 21, 2020, was coupled with Centers for Disease Control and Prevention records of COVID-19 diagnoses and state-level police killings. Multinomial logistic regression assessed the relative contribution of COVID-19 deaths, police violence, unemployment, fear of unemployment, change in educational delivery, and geographic location to anxiety among racial/ethnic cohorts with and without children., Results: Anxiety frequency increased over the sample for all groups. However, White anxiety was highly responsive to state-level COVID-19 fatalities, while Black anxiety was highly correlated with police violence. Households with children showed higher levels of anxiety during nontraditional educational delivery, whereas both households with and without children experienced high levels of fear regarding employment uncertainty and poverty., Conclusions: Experiences in 2020 impacted all groups differently, but each showed a high frequency of anxiety., (© 2021. W. Montague Cobb-NMA Health Institute.)

Haitians are the fourth largest Afro-Caribbean immigrant group in the USA, and there is a dearth of research focusing on the factors impacting their lives. As a marginalized group with extensive pre-existing conditions, Haitian immigrants are disproportionately affected by the pandemic in areas such as education, health, and economics. This paper provides a summary of existing disparities among Haitians in the USA and how COVID-19 has significantly impacted this group. It concludes with an analysis of how the Strategic Framework for Improving Racial and Ethnic Minority Health and Eliminating Racial and Ethnic Health Disparities can be used to guide, organize, and coordinate systematic planning for sustainable changes to address these disparities. Addressing immigrant and minority health in the USA requires a deeper dive into the various immigrant groups. This paper concludes with recommendations for research and policy changes necessary to eliminate disparities in the USA., (© 2021. W. Montague Cobb-NMA Health Institute.)

Background: The cost of healthcare has become expensive globally, of which the greater part of the money is spent on buying innovator medicines. In order to make medicine affordable, the development of generic medicines has become paramount. The science of bioequivalence studies of generic products to demonstrate therapeutic equivalence with innovator products has been developed over the last 50 years. These studies cost far less as compared to innovator products thereby reducing the cost of medicines. Accelerating access to medicines has become an increasing challenge due to insufficient resources from regulatory authorities, while pharmaceutical industry continues to expand. An investigation on the deficiencies identified during scientific assessments by SAHPRA in submitted bioequivalence studies is therefore paramount. Identification and publication of these deficiencies will assist in accelerating the access of medicines to patients., Objective: The aim of the study is to investigate the types and frequency of the common deficiencies observed in the bioequivalence section of generic submissions to SAHPRA. The study was conducted retrospectively over a 7-year period (2011-2017) for generic products that were finalised by the Pharmaceutical and Analytical pre-registration Unit. A more recent analysis on common deficiencies witnessed for applications assessed between 2020 and 2021 was also done to illustrate the consistency in the evaluation practises adopted by SAHPRA., Methods: There were 3148 applications finalised between 2011 and 2017, and to attain a representative sample for the study, statistical sampling was conducted. The multi-stage sampling called stratified systematic sampling was selected as the method of choice. The sample size was obtained using the statistical tables found in the literature and confirmed by a sample size calculation resulting in the selection of 325 applications (Fig. 2a). Additionally, 300 master applications were assessed between 2020 and 2021 for up-to-date data (Fig. 2b). All the deficiencies were collected and categorised according to the ICH E3 guideline and components relevant to biostudies., Results: A total of 2458 deficiencies were collected from the selected sample size for applications finalised between 2011 and 2017 where a biostudy was submitted. The majority of the identified deficiencies were from the following categories; in vitro dissolution testing and specifications (18%), study design (17%), details on the test and reference products (16%), issues on sample analysis (16%), and statistical analysis (10%) (Fig. 3). From the applications assessed in 2020-2021, 492 deficiencies were identified with a similar trend compared to those finalised between 2011 and 2017. Comparison of the deficiencies with those reported by the USFDA and WHO PQTm is discussed with similarities outlined., Conclusions: The five most common deficiencies observed were extensively discussed. The outcomes of this study will guide pharmaceutical companies, sponsors, and Clinical Research Organisations (CROs) in submitting quality biostudies which will reduce turnaround times for registration and accelerate access to medicines for patients. In addition, the deficiencies identified will assist assessors from the different regulatory authorities to improve on their bioequivalence assessment., (© 2022. The Author(s), under exclusive licence to The Drug Information Association, Inc.)

This study investigated the relationship between race and psychological distress among Latinxs in the United States. Using data from the National Health Interview Survey (NHIS) 2010-2018, we estimated the relative risk ratios (RRR) of experiencing psychological distress among White, Black and Other Latinxs from Mexico, Cuba, Dominican Republic, and Puerto Rico. Results revealed that Black Latinxs experienced higher levels of psychological distress than their White counterparts. Additional analysis among and within groups showed that Puerto Ricans and Dominicans reported higher psychological distress than Mexicans, and that race was associated with the distress of Cubans and Mexicans, but not with the distress of Puerto Ricans and Dominicans. Future work on the effect of racial self-identification on Latinxs' mental health-related outcomes, such as psychological distress, should include multidimensional measures of racial identity, such as self-reported and ascribed race, racial ideology, as well as measures of skin color and discrimination. Integrating racialization experiences during clinical assessments would help practitioners to gain a more comprehensive picture of how these identities and experiences may shape the stress, distress, and mental health outcomes (e.g., depression, anxiety) of different racial and ethnic Latinx groups in the U.S., (© 2021. W. Montague Cobb-NMA Health Institute.)

Background: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is undertaking a major revision of ICH E6 Good Clinical Practice (GCP) decided to involve external stakeholders in ICH-GCP renovation. Activities such as surveys and public conferences have taken place in the United States, European Union, and Japan. For stakeholder engagement in Japan, a designated research group conducted a survey of academic stakeholders., Methods: A total of 105 academic stakeholders from 18 institutions responded to the survey. The research group developed recommendations reflecting the survey results and the opinions from patients and the public., Results: The survey showed the top four principles needing renovation were (i) informed consent (Chapter 2.9, 12.4% of respondents believed it needed renovation), (ii) systems for quality assurance (Chapter 2.13, 9.5%), (iii) information on an investigational product (Chapter 2.4, 5.7%), and (iv) procedures on clinical trial information (Chapter 2.10, 5.7%). The top three sections identified as needing renovation were: (i) informed consent (Chapter 4.8, 27.6%), (ii) monitoring (Chapter 5.18, 22.9%), and (iii) composition, functions, and operations of the ethics committee (Chapter 3.2, 14.3%). Recommendations included clarification of ICH-GCP's scope, proportionality in various aspects of clinical trials, diversity and liquidity of ethics committee members, modernization of informed consent procedures, variations in monitoring, and regulatory grade when using real-world data., Conclusion: The recommendations from Japanese investigators and patients have been submitted to the ICH E6 Expert Working Group, which will strengthen the robustness of the GCP renovation., (© 2021. The Author(s).)

The US Food and Drug Administration (FDA) regulates medical devices (MD), which are predicated on a concoction of economic and policy forces (e.g., supply/demand, crises, patents), under primarily two administrative circuits: premarketing notifications (PMN) and Approvals (PMAs). This work considers the dynamics of FDA PMNs and PMAs applications as an proxy metric for the evolution of the MD industry, and specifically seeks to test the existence [and, if so, identify the length scale(s)] of economic/business cycles. Beyond summary statistics, the monthly (May, 1976 to December, 2020) number of observed FDA MD Applications are investigated via an assortment of time series techniques (including: discrete wavelet transform, running moving average filter, complete ensemble empirical mode with adaptive noise decomposition, and Seasonal Trend Loess decomposition) to exhaustively seek and find such periodicities. This work finds that from 1976 to 2020, the dynamics of MD applications are (1) non-normal, non-stationary (fractional order of integration < 1), non-linear, and strongly persistent (Hurst > 0.5); (2) regular (non-variance), with latent periodicities following seasonal, 1-year (short-term), 5-6 year (Juglar; mid-term), and a single 24-year (Kuznets; medium-term) period (when considering the total number of MD applications); (3) evolving independently of any specific exogenous factor (such as the COVID-19 crisis); (4) comprised of two inversely opposing processes (PMNs and PMAs) suggesting an intrinsic structural industrial transformation occurring within the MD industry; and, (6) predicted to continue its decline (as a totality) into the mid-2020s until recovery. Ramifications of these findings are discussed., (© 2021. The Drug Information Association, Inc.)

Objective: Racial/ethnic disparities in obesity may be due, in part, to minority groups consuming more energy-rich diets in response to greater stress exposure. The present study systematically reviewed the literature describing the effects of stress on food consumption among various racial/ethnic groups in the US., Methods: PubMed and PsycINFO databases were searched for studies reporting associations between stress and food consumption by different racial/ethnic groups, conducted between January 1, 1999 to November 25, 2019. The search included terms related to food consumption, stress, and race/ethnicity. After screening 3660 records, 30 studies were included for review., Results: The selected studies assessed diverse stressors and eating constructs; African-American and Hispanic/Latinx were the most commonly studied minority groups. Studies generally supported that diverse forms of stress exposure are associated with reduced healthy eating patterns and increased obesogenic eating patterns across racial/ethnic groups. However, studies that directly compared stress-eating associations among multiple racial/ethnic groups showed mixed results., Conclusion: Members of diverse racial/ethnic groups are susceptible to stress-induced unhealthy eating patterns, though evidence is insufficient to conclude whether the degree of susceptibility differs among groups. Additional studies utilizing observational measures of food intake and culturally sensitive measures of stress are needed to identify the most influential stressors on dietary behaviors, to assess whether some stressors are more salient for given racial/ethnic groups, and to examine the extent to which stress-induced eating contributes to racial/ethnic disparities in obesity and obesity-related diseases., (© 2020. W. Montague Cobb-NMA Health Institute.)

It is challenging to elucidate the effects of changes in external influences (such as economic or policy) on the rate of US drug approvals. Here, a novel approach-termed the Chronological Hurst Exponent (CHE)-is proposed, which hypothesizes that changes in the long-range memory latent within the dynamics of time series data may be temporally associated with changes in such influences. Using the monthly number FDA's Center for Drug Evaluation and Research (CDER) approvals from 1939 to 2019 as the data source, it is demonstrated that the CHE has a distinct S-shaped structure demarcated by an 8-year (1939-1947) Stagnation Period, a 27-year (1947-1974) Emergent Period, and a 45-year (1974-2019) Saturation Period. Further, dominant periodicities (resolved via wavelet analyses) are identified during the most recent 45-year CHE Saturation Period at 17, 8 and 4 years; thus, US drug approvals have been following a Juglar/Kuznet mid-term cycle with Kitchin-like bursts. As discussed, this work suggests that (1) changes in extrinsic factors (e.g., of economic and/or policy origin) during the Emergent Period may have led to persistent growth in US drug approvals enjoyed since 1974, (2) the CHE may be a valued method to explore influences on time series data, and (3) innovation-related economic cycles exist (as viewed via the proxy metric of US drug approvals).

The objective of this study is to describe racial differences in type 2 diabetes mellitus "diabetes" control among the adults in the USA, and to examine attributes that may exacerbate racial differences. Secondary analyses of data from the National Ambulatory Medical Care Survey (NAMCS) collected in years 2012-2014 in the USA. Study sample was limited to White or African American patients aged 25 or older and living with diabetes (n = 4106). Outcome measure, poor diabetes control, was based on lab values for HbA1c (> 7%). Covariates include demographics, insurance, comorbid conditions, and continuity of care and location (urban vs. rural). Overall, African Americans have 33% higher odds of poor diabetes control compared with Whites. Adjusted probability of poor diabetes control was 48% overall, 65% for African American women and 69% for African Americans living in rural areas. African Americans continue to have poorer diabetes control compared to Whites. This difference is exacerbated for African American women, and for all African Americans living in rural areas. Policy should include concentrated screening and treatment resources for African Americans in rural settings.

As with other national disasters, epidemics, and pandemics, the novel coronavirus SARS-CoV-2 (COVID-19) pandemic has highlighted health disparities in Black communities in the USA. Healthcare providers, community activists, politicians, members of faith-based organizations, professional athletes, and Black families are asking crucial questions about why Black and Brown people are disproportionately infected by, and dying from, the COVID-19. Evidence in healthcare and social sciences literature demonstrates that historically, systemic racism and injustices play a large role in the health and well-being of Blacks living in the USA. For decades, the National Black Nurses Association has been on the forefront, engaging our people using a collaborative community-based practice model. The healthcare goal in the USA should center on health protection, promotion, and prevention, moving toward a wellness model and away from treatment of illnesses that contribute to healthcare waste. Finally, awareness of social determinants of health has taken center stage, demonstrating how laws, policies, and practice affect health outcomes and the well-being of Black and Brown communities. In order to address social determinants of health and healthcare inequity, the National Black Nurses Association has called for an increase in the number of Black registered nurses and licensed vocational and practical nurses. The healthcare goal in the USA should center on health protection, promotion, and preventions moving toward a wellness model and away from treatment of illnesses that contributes to healthcare waste.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-19; HCoV-19; COVID-19) has affected all daily activities. Has it also affected the number of United States (FDA) drug approvals over time? The short answer from empirical time series forecasting is not yet. Care should be taken as the crisis continues through maintaining the scientific, economic, political, and social supportive structures to sustain momentum. This conclusion is based on analyzing the results of (non-overlapping) forecasting routines (viz., complex exponential smoothing, auto-regressive fractionally integrated moving average, extreme learning machine, and multi-layer perceptron) performed on longitudinal (1939-present) FDA (CDER) drug approvals taking into regard pre- and extant-COVID-19 eras. This is an initial study and there are caveats with the approach, and as such, all data and programs are provided to support replication of the results and furthering of the investigation.

Background: Placebo-controlled trials are the most rigorous method of evaluating the safety and efficacy of investigational treatments, yet the use of a placebo control in pediatric drug development is challenging and potentially controversial. Regulations provide additional protections for children participating in human subject research and limit the amount of risk to which children may be exposed without benefit (21 CFR 50, subpart D, Additional Safeguards for Children in Clinical Investigations). The objective of this paper is to describe the US Food and Drug Administration (FDA) experience with placebo-controlled trials conducted as part of pediatric drug development programs including compliance with 21 CFR 50, subpart D., Methods: Pediatric drug development programs conducted under the Best Pharmaceuticals for Children Act (BPCA) or the Pediatric Research Equity Act (PREA) between 2012 and 2018 were reviewed. Trials that utilized a placebo control were identified and trial characteristics and risk mitigation strategies were extracted from publicly available sources., Results: During this time frame, a total of 266 products were studied under pediatric product development initiatives. Of those, 67 products (25%) were studied in 96 individual placebo-controlled trials in pediatric patients. The majority of these studies included approaches to minimize risk to children in the placebo arm, including 49 trials that utilized placebo as an add-on to known effective therapy for the disease and 48 trials that included rescue therapy in the study protocol., Conclusions: When designed and conducted appropriately, placebo-controlled trials meet requirements under current US federal regulations for the protection of children in research.

The Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA) regulates gene therapies, among other products. The approval of four gene therapy products since 2017 represents a significant milestone for a new class of treatments with the potential to treat or cure diseases, particularly rare diseases, that were previously considered incurable. Several factors have contributed to the recent rapid development of gene therapies including advances in genetics to facilitate target-detection, advances in vectors, and regulatory incentives such as breakthrough therapy designation, priority review and market exclusivity. The patient population affected by a rare disease is typically small, heterogeneous and geographically dispersed. As a result, clinical trials on a rare disease have unique features in terms of study design, subject enrollment, data analyses and interpretation of study results. Given that the patient population affected is small for rare diseases, providing substantial evidence of effectiveness and evidence of safety in trials for rare disease presents challenges. In this paper, we share our experiences in the statistical review of three gene therapy products that have been approved by FDA CBER. Our motivation in writing this paper is to encourage the use of appropriate analysis strategies for other similar small trials, with a focus on data visualization strategies.

Background: Patient registries are organized systems that use observational methods to collect uniform data on specified outcomes in a population defined by a particular disease, condition, or exposure. Data collected in registries often coincide with data that could support clinical trials. Integrating clinical trials within registries to create registry-embedded clinical trials offers opportunities to reduce duplicative data collection, identify and recruit patients more efficiently, decrease time to database lock, accelerate time to regulatory decision-making, and reduce clinical trial costs. This article describes a project of the Clinical Trials Transformation Initiative (CTTI) intended to help clinical trials researchers determine when a registry could potentially serve as the platform for the conduct of a clinical trial., Methods: Through a review of registry-embedded clinical trials and commentaries, semi-structured interviews with experts, and a multi-stakeholder expert meeting, the project team addressed how to identify and describe essential registry characteristics, practices, and processes required to for conducting embedded clinical trials intended for regulatory submissions in the United States., Results: Recommendations, suggested practices, and decision trees that facilitate the assessment of whether a registry is suitable for embedding clinical trials were developed, as well as considerations for the design of new registries. Essential registry characteristics include relevancy, robustness, reliability, and assurance of patient protections., Conclusions: The project identifies a clear role for registries in creating a sustainable and reusable infrastructure to conduct clinical trials. Adoption of these recommendations will facilitate the ability to perform high-quality and efficient prospective registry-based clinical trials.

Objective: To explore the social determinants of mental health (SDoMH) by race/ethnicity in a sample with equal access to healthcare. Using an adaptation of the World Health Organization's SDoMH Framework, this secondary analysis examines the socio-economic factors that make up the SDoMH by race/ethnicity., Method: This paper employed configurational comparative methods (CCMs) to analyze various racial/ethnic subsets from quantitative survey data from (N = 327) active-duty Army wives. Data was collected in 2012 by Walter Reed Army Institute of Research., Results: Initial exploratory analysis revealed the highest-scoring factors for each racial/ethnic subgroup: non-Hispanic Black: employment and a history of adverse childhood events (ACEs); Hispanic: living off post and a recent childbirth; junior enlisted non-Hispanic White: high work-family conflict and ACEs; non-Hispanic other race: high work-family conflict and not having a military history. Final analysis showed four models consistently explained clinically significant depression symptoms and four models consistently explained the absence of clinical depression symptoms, providing a solution for each racial/ethnic minority group (non-Hispanic Black, Hispanic, junior enlisted non-Hispanic White, and non-Hispanic other)., Discussion: These findings highlight that Army wives are not a monolithic group, despite their collective exposure to military-specific stressors. These findings also highlight the potential for applying configurational approaches to gain new insights into mental health outcomes for social science and clinical researchers., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

The United States (US) Food and Drug Administration (FDA) Investigational New Drug (IND) Final Rule (US FDA, Final rule: Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans, 2010) applies to all human drugs and biological products being studied under an IND. The Final Rule specifies that a sponsor must file an IND safety report for any Suspected Unexpected Serious Adverse Reaction (SUSAR) of a medicinal product being investigated. To make a proper SUSAR classification, sponsors need to go beyond conventional Data Monitoring Committees (DMCs) with an interdisciplinary effort, using all relevant data (including data outside clinical trials), to make judgments on the possibility of serious adverse events being caused by the study drug-rather than the underlying condition of the patient or a concomitant therapy. Ball et al. (Ball et al. in Ther Innov Regul Sci 55:705-716, 2021) have reported on how the Final Rule has been implemented by large pharmaceutical companies. This paper explores the experiences of small sponsor companies regarding the Final Rule, to understand the current challenges that they have been facing to meet aggregate IND safety reporting requirements., (© 2024. The Author(s), under exclusive licence to The Drug Information Association, Inc.)

Background: Exposure to air pollutants and other environmental factors increases the risk of adverse pregnancy outcomes. There is growing evidence that adverse outcomes related to air pollution disproportionately affect racial and ethnic minorities. The objective of this paper is to explore the importance of race as a risk factor for air pollution-related poor pregnancy outcomes., Methods: Studies investigating the effects of exposure to air pollution on pregnancy outcomes by race were reviewed. A manual search was conducted to identify missing studies. Studies that did not compare pregnancy outcomes among two or more racial groups were excluded. Pregnancy outcomes included preterm births, small for gestational age, low birth weight, and stillbirths., Results: A total of 124 articles explored race and air pollution as risk factors for poor pregnancy outcome. Thirteen percent of these (n=16) specifically compared pregnancy outcomes among two or more racial groups. Findings across all reviewed articles showed more adverse pregnancy outcomes (preterm birth, small for gestational age, low birth weight, and stillbirths) related to exposure to air pollution among Blacks and Hispanics than among non-Hispanic Whites., Conclusion: Evidence support our general understanding of the impact of air pollution on birth outcomes and, specifically, of disparities in exposure to air pollution and birth outcomes for infants born to Black and Hispanic mothers. The factors driving these disparities are multifactorial, mostly social, and economic factors. Reducing or eliminating these disparities require interventions at individual, community, state, and national level., (© 2023. The Author(s).)

Background: Throughout the coronavirus (COVID-19) pandemic, research revealed people of color were more likely to be infected, have severe illness, and die due to the virus. However, some areas in the USA are now reporting a new shift; lower Black and Hispanic COVID-19 mortality rates compared to their White counterparts. Research indicates that this shift is the result of COVID-19's impact on disparities by race. In this paper, we analyze death data to determine if the new shift has occurred locally. Specifically, we examined COVID-19 prevalence and related death data in Connecticut by comparing race/ethnicity through two periods of time: one before and one after the first case of the Omicron variant of COVID-19., Methods: This cross-sectional epidemiological analysis to examine cases and deaths by racial/ethnic status utilizes Connecticut data from March 2020 to February 2022. The following assumption is applied: expected pre-Omicron cases and deaths from March 5, 2020 to November 27, 2021 are equal to the number of cases and deaths during Omicron cases and deaths from November 28, 2021 to February 17, 2022. Race/ethnicity are operationalized as non-Hispanic White, non-Hispanic Black, and Hispanic., Results: Pre-Omicron (March 5, 2020 to November 27, 2021) compared to the monthly aged adjusted COVID-19 case rate for Whites (394/10,000 populations), Blacks had a higher rate (501/10,000 populations), and Hispanics had the highest (585/10,000 populations). During the Omicron period (November 28 to February 17, 2022), significant changes in COVID-19 case rates were observed in all three ethnic groups, but the biggest changes were observed in Hispanics, followed by Blacks, and then Whites. The rate ratios further showed a remarkable reduction of 47% in case rates (from 1.0 pre-Omicron and from 1.47 during Omicron, p < 0.0001) for Hispanics, when compared to that of Whites. While Blacks showed a significant, smaller reduction of 5% in case rates (from 1.27 pre-Omicron and from 1.22 during the Omicron, p < 0.001) when compared to Whites. Regarding COVID-19-related mortality, the racial differences were similar., Conclusions and Relevance: By examining Connecticut's COVID-19 death and case data, this study identified the new shift that occurred locally. The current shift may be anchored in the evolution of the COVID-19 virus, public health guidelines/policies, and the degree to which populations have complied with public health recommendations., (© 2023. W. Montague Cobb-NMA Health Institute.)

Introduction: Structural racism is strongly related to racial health disparities. However, surprisingly few studies have developed empirical tools to measure structural racism. In addition, the few measures that have been employed have only considered structural racism at the neighborhood level. To expand upon previous studies, this paper uses a novel measure to measure structural racism at the county level for the non-Hispanic Black population., Methods: We used confirmatory factor analysis to create a model to measure the latent construct of structural racism for 1181 US counties. The model included five indicators across five dimensions: racial segregation, incarceration, educational attainment, employment, and economic status/wealth. Structural equation modeling and factor analysis were used to generate factor scores that weighted the indicators in order to produce the best model fit. The resulting factor scores represented the level of structural racism in each county. We demonstrated the utility of this measure by demonstrating its strong correlation with Black-White disparities in firearm homicide rates., Results: Our calculations revealed striking geographic differences across counties in the magnitude of structural racism, with the highest values generally being observed in the Midwest and Northeast. Structural racism was significantly associated with higher Black firearm homicide rates, lower White homicide rates, and a higher Black-White racial disparity in firearm homicide., Conclusions: These new measures can be utilized by researchers to relate structural racism to racial health disparities at the county level., (© 2022. The Author(s).)

Objective: To report the domains of Black mothers' experiences with preterm infants in the neonatal intensive care unit (NICU) and to determine the frameworks used., Methods: A systematic review of the literature using the PRISMA guideline was performed. An electronic database search of published literature between 2000 and 2022 was conducted based on predetermined search terms and parameters., Results: Twenty-seven articles met the inclusion and exclusion criteria. Eleven articles focused on feeding practices, ten reported on nursing/maternal care experiences, five reported mental health/social support, and only one focused on mother-infant relationships. Only five papers reported using any frameworks, comprising grounded theory framework (n = 2), theory of planned behavior (n = 1), research justice framework (n = 1), and the patient and public engagement protocol (n = 1)., Discussion: A holistic approach to understanding the multifactorial experiences of Black mothers with preterm infants needs to be socio-culturally competent to ensure their diverse intersections and identities are accurately represented and understood. Rigorous research at the intersection of Black maternal health and the NICU hold promises for advancing maternal health equity in the United States., (© 2022. W. Montague Cobb-NMA Health Institute.)

Despite growing interest in the health-related consequences of racially discriminatory institutional policies and practices, public health scholars have yet to reach a consensus on how to measure and analyze exposure to institutional racism. The purpose of this paper is to provide an overview of the conceptualization, measurement, and analysis of institutional racism in the context of quantitative research on minority health and health disparities in the United States. We begin by providing definitions of key concepts (e.g., racialization, racism, racial inequity) and describing linkages between these ideas. Next, we discuss the hypothesized mechanisms that link exposure to institutional racism with health. We then provide a framework to advance empirical research on institutional racism and health, informed by a literature review that summarizes measures and analytic approaches used in previous studies. The framework addresses six considerations: (1) policy identification, (2) population of interest, (3) exposure measurement, (4) outcome measurement, (5) study design, and (6) analytic approach. Research utilizing the proposed framework will help inform structural interventions to promote minority health and reduce racial and ethnic health disparities., (© 2022. W. Montague Cobb-NMA Health Institute.)

The Affordable Care Act (ACA) has substantially expanded access to health insurance coverage, resulting in a reduction in financial hardship, defined as ability to pay medical bills, among cardiovascular disease (CVD) patients in the post-ACA era. However, it is not known whether implementation of the ACA improved the racial and ethnic inequity in financial hardship among CVD patients. As such, using data from the 2011 to 2018 waves of the National Health Interview Survey (NHIS), this paper aims to assess the odds of facing financial hardship among non-Hispanic-White, -Black, -Asian, and Hispanic CVD patients, before and after the implementation of the ACA. Our sample consists of 12,688 CVD patients in pre-ACA (2011-2013), 9128 CVD patients in early (2014-2015), and 11,863 CVD patients in later phase of the ACA (2016-2018). We performed multivariable logistic regressions to examine how the odds, in favor of facing financial hardship, varied between non-Hispanic White and other race/ethnic categories across the pre- and post-ACA periods. Though the overall prevalence of financial hardship was reduced from 22 to 18%, a considerable disparity between Black and Hispanic, and White CVD patients persisted from pre-ACA to post-ACA periods. The odds of experiencing financial hardship for Black and Hispanic CVD patients were, respectively, 2.25 to 2.16 and 1.52 to 1.78 times that of their White counterparts across the periods. Though the ACA is a positive step towards improving healthcare access and affordability, further initiatives are needed to reduce inequities across racial and ethnic minorities., (© 2022. W. Montague Cobb-NMA Health Institute.)

Little is known about racial differences in the incidence of light chain (AL) amyloidosis despite the well-documented racial disparities in the epidemiology of other plasma cell disorders. The goal of this study was to examine the extent to which published clinical research in AL amyloidosis report information on patients' race. Clinical research publications in AL amyloidosis between January 1, 2010, and December 31, 2020, from the USA were identified. In addition to the reporting of race, study design, funding, cohort size, year of publication, impact factor of publication journal, and first author degree were abstracted. Among papers reporting race, we also assessed whether ethnicity was reported separately. A PubMed search yielded 2,770 papers of which 220 met the pre-specified criteria for analysis. Of those, 37 (16.5%) reported race. Single institution publications, those with physicians as first authors, and those published in journals with impact factor 6 or higher were less likely to report race. On multivariate analysis, only single institution studies were negatively associated with race reporting. Of the 37 papers reporting race, none defined it in methods, 16% stated how race was identified, and 19% discussed its significance. Ethnicity was reported in 6 studies. Our results indicate that race/ethnicity is underreported in USA. AL amyloidosis clinical literature leads to a challenge for identifying potential racial/ethnic disparities. Standards for collecting and reporting racial/ethnic demographics are needed. Clear and consistent reporting of race and ethnicity of clinical populations is a necessary first step in identifying disparities and promoting equitable care., (© 2022. W. Montague Cobb-NMA Health Institute.)

Objectives: There remains ongoing debate regarding the relative efficacy of public (NIH) and private sector funding in bringing biopharmaceutical innovations to market. This paper investigates the significance of each party's level of funding for obtaining Food and Drug Administration (FDA) authorization., Methods: A cohort of research projects linked to 23,230 National Institute of Health grants awarded in the year 2000 was audited to account for patents, where the project led to a product in clinical development and potentially FDA approval. A total of 8126 associated patents led to the identification of 41 therapies that registered clinical trials; 18 of these therapies received FDA approved., Results: NIH funding for the 18 FDA-approved therapies totaled $0.670 billion, whereas private sector funding (excluding post-approval funding) totaled $44.3 billion. A logistic regression relating the levels of public and private funding to the probability of FDA approval indicates a positive and significant relationship between private sector funding and the likelihood of FDA approval (p ≤ 0.0004). The relationship between public funding and the likelihood of FDA approval is found to be negative and not statistically significant., Conclusion: Our study results underscore that the development of basic discoveries requires substantial additional investments, partnerships, and the shouldering of financial risk by the private sector if therapies are to materialize as FDA-approved medicine. Our finding of a potentially negative relationship between public funding and the likelihood that a therapy receives FDA approval requires additional study., (© 2022. The Author(s).)

Introduction: Although disparities in COVID-19 mortality have been documented at the national and state levels, no previous study has quantified such disparities at the county level by explicitly measuring race-specific COVID-19 death rates. In this paper, we quantify the racial/ethnic disparities in COVID-19 mortality between the non-Hispanic Black and non-Hispanic White populations at the county level by estimating age-adjusted, race-specific death rates., Methods: Using COVID-19 case data from the Centers for Disease Control and Prevention, we calculated crude and indirect age-adjusted COVID-19 mortality rates for the non-Hispanic White and non-Hispanic Black populations in each of 353 counties for the period February 2, 2020, through January 30, 2021. Using linear regression analysis, we examined the relationship between several county-level measures of structural racism and the observed differences in racial disparities in COVID-19 mortality across counties., Results: Ninety-three percent of the counties in our study experienced higher death rates among the Black compared to the White population, with an average ratio of Black to White death rates of 1.9 and a 17.5-fold difference between the disparity in the lowest and highest counties. Three traditional measures of structural racism were significantly related to the magnitude of the Black-White racial disparity in COVID-19 mortality rates across counties., Conclusions: There are large disparities in COVID-19 mortality rates between the Black and White populations at the county level, there are profound differences in the level of these disparities, and those differences are directly related to the level of structural racism in a given county., (© 2021. W. Montague Cobb-NMA Health Institute.)

Much of what has been written about the history of medical genetics in North America has focused on physician involvement in eugenics and the transition from heredity counseling to genetic counseling in the United States. What are typically missing in these accounts are details concerning the formation of a new medical specialty, i.e., medical genetics, and Canada's involvement in specialty formation. Accordingly, this paper begins to fill in gaps by investigating, on the one hand, the history of American and Canadian geneticists working together to support the creation of examining and teaching positions in human genetics in North American medical schools and, on the other, working independently of one another to monitor the rate and direction of workloads and patient access to local genetic counseling and laboratory services and, subsequently, achieve recognition for medical genetics as a medical specialty at the national level., (© 2022. Springer Nature Switzerland AG.)

Racial and geographical disparities exist in HIV infections in the USA. The highest burden of HIV diagnoses remains among Black/African American persons and is concentrated in the Southern region. This paper describes within-race changes in HIV diagnoses among heterosexually active Black/African American persons in seven states with the highest rates/100,000 population of HIV diagnoses in the South, during 2014-2018. The total number of diagnoses among Black males and females with infection attributed to heterosexual contact decreased in 2018 compared to 2014. Diagnoses decreased among Black males and females in Louisiana and among Black females in Texas. While the declines indicate progress, Black males and females in the South remain disproportionately affected by HIV. Results support a need for the development, implementation, and evaluation of evidence-based HIV prevention interventions and strategies for heterosexually active persons in jurisdictions that have not seen decreases in HIV diagnoses., (© 2021. W. Montague Cobb-NMA Health Institute.)

This paper traces the diverse contexts of radiation protection from liberation in post-1945 South Korea to its professionalization by the early 1970s, using the emerging field of health physics (보건 물리학) as the focus. The Korean nuclear center, AERI (Atomic Energy Research Institute/한국 원자력 연구소, 1959), started two affiliates, RRIA (Radiation Research Institute for Agriculture/방사선 농업연구소, 1966) and RRIM (Radiation Research Institute for Medicine/방사선 의학연구소, 1963) in the early 1960s. In particular, RRIM emphasized the use of radiation within cancer research, especially the use of cobalt in treating patients. In this context, health physics initially took the form of "radiation medicine."With the two institutes returning to AERI's fold in 1973, health physics took another turn: the second major subfield, following "radiation medicine," invoked a broader conception of "radiation protection," which now referred to a cluster of related interests, including the environment and the effects of industrialization.Rather than a simple transfer of American and international models after 1953, Korean health physics reflects its origins in a post-colonial research setting, one more diverse than its "official" institutional context at AERI., (© 2022. The Author(s).)

Introduction: While the increased burden of COVID-19 among the Black population has been recognized, most attempts to quantify the extent of this racial disparity have not taken the age distribution of the population into account. In this paper, we determine the Black-White disparity in COVID-19 mortality rates across 35 states using direct age standardization. We then explore the relationship between structural racism and differences in the magnitude of this disparity across states., Methods: Using data from the Centers for Disease Control and Prevention, we calculated both crude and age-adjusted COVID-19 mortality rates for the non-Hispanic White and non-Hispanic Black populations in each state. We explored the relationship between a state-level structural racism index and the observed differences in the racial disparities in COVID-19 mortality across states. We explored the potential mediating effects of disparities in exposure based on occupation, underlying medical conditions, and health care access., Results: Relying upon crude death rate ratios resulted in a substantial underestimation of the true magnitude of the Black-White disparity in COVID-19 mortality rates. The structural racism index was a robust predictor of the observed racial disparities. Each standard deviation increase in the racism index was associated with an increase of 0.26 in the ratio of COVID-19 mortality rates among the Black compared to the White population., Conclusions: Structural racism should be considered a root cause of the Black-White disparity in COVID-19 mortality. Dismantling the long-standing systems of racial oppression is critical to adequately address both the downstream and upstream causes of racial inequities in the disease burden of COVID-19., (© 2021. The Author(s).)

Substantial health disparities exist across race/ethnicity in the USA, with Black Americans often most affected. The current COVID-19 pandemic is no different. While there have been ample studies describing racial disparities in COVID-19 outcomes, relatively few have established an empirical link between these disparities and structural racism. Such empirical analyses are critically important to help defuse "victim-blaming" narratives about why minority communities have been badly hit by COVID-19. In this paper, we explore the empirical link between structural racism and disparities in county-level COVID-19 outcomes by county racial composition. Using negative binomial regression models, we examine how five measures of county-level residential segregation and racial disparities in socioeconomic outcomes as well as incarceration rates are associated with county-level COVID-19 outcomes. We find significant associations between higher levels of measured structural racism and higher rates of COVID-19 cases and deaths, even after adjusting for county-level population sociodemographic characteristics, measures of population health, access to healthcare, population density, and duration of the COVID-19 outbreak. One percentage point more Black residents predicted a 1.1% increase in county case rate. This association decreased to 0.4% when structural racism indicators were included in our model. Similarly, one percentage point more Black residents predicted a 1.8% increase in county death rates, which became non-significant after adjustment for structural racism. Our findings lend empirical support to the hypothesis that structural racism is an important driver of racial disparities in COVID-19 outcomes, and reinforce existing calls for action to address structural racism as a fundamental cause of health disparities., (© 2021. W. Montague Cobb-NMA Health Institute.)

Although public health has made substantial advances in closing the health disparity gap, Black Americans still experience inequalities and inequities. Several theoretical frameworks have been used to develop public health interventions for Black American health; yet the existing paradigms do not fully account for the ontology, epistemology, or axiology of Black American populations. The Black Lives Matter (BLM) movement provides a basis for understanding the constructs that may contribute to Black American health. By drawing from the 13 BLM principles, this paper presents an alternative approach for developing, implementing, and evaluating public health interventions for Black populations in the USA. Furthermore, the approach may inform future public health research and policies to reduce health disparities within and across Black populations in the USA., (© 2020. The Author(s).)

The era dominated by the liberal world order, dating back to the end of World War II in 1945 and gaining unchallenged dominance with the fall of the Berlin Wall in 1989, is now coming to an end. Yet the universal principles that the era personified in its rhetoric, and in the best of its actions, lives on. The global community has a moral obligation to continue on its journey to build a more equitable, secure and prosperous world for all of its citizens and must devise investment strategies that enable progress to both endure and accelerate. "The Declaration on Science and the Use of Scientific Knowledge," issued at the conclusion of the inaugural World Conference on Science in 1999, contained a broad range of insights and recommendations that remain as significant today as they did 20 years ago. We would be wise to heed the challenges that the declaration conveyed by recognizing that the journey for equity in science, technology and innovation (STI) is by no means over and, in fact, remains as relevant now as it did then-both as an economic and social necessity and as a moral obligation. This paper seeks to explore how patterns of investment in STI have changed over the past 2 decades-and how they have not., (© 2020. Akadémiai Kiadó Zrt.)

With Black and Hispanic communities across the USA experiencing more detrimental negative effects from the COVID-19 pandemic as compared with other demographic groups, the virus has exposed the racial and ethnic disparities in treatment and care that public health experts have been grappling with for years. This paper explains how the systematic collection of racial and ethnic data gleaned from COVID-19 testing in underserved communities can be used to better understand this pandemic and inform measures within our control to prevent the spread of disease in the future.

As cases of COVID-19 continue to rise, some countries, including the US, Chile, and Germany, have considered issuing "immunity passports." This possibility has raised concerns and debate regarding their potential social, political and economic ramifications, especially for marginalized communities. This paper contributes to that debate by exposing that ways in which immunoprivilege already exists and operates within our present system of structural inequalities.

Objectives: There is a notable lack of research on the risk factors for multimorbidity, which has become more common over recent decades. Black Americans experience discrimination more often than their White counterparts, and also have significantly higher prevalence of multimorbidity. This paper examines the associations between discrimination and multimorbidity among Black Americans., Methods: We analyzed data from the National Survey of American Life to calculate the prevalence of two types of discrimination (everyday discrimination, major discriminatory events) and multimorbidity (physical, psychiatric, mixed, any). Using multivariable logistic regression, we examined the associations between discrimination and multimorbidity, adjusting for age, sex, years of education, income-to-poverty ratio, and ethnicity. The everyday discrimination scale was discretized into five categories (none, low, medium, high, very high), but was also treated as a continuous variable. The major discriminatory events were analyzed in separate adjusted models, and as a count of events., Results: When compared with those who did not experience any discrimination, people who experienced everyday discrimination were significantly more likely to report all types of multimorbidity in a dose-response fashion at a conventional level of statistical significance. Most major discriminatory events were associated with greater odds of reporting all types of multimorbidity, as were the counts of major discriminatory events, in a dose-response fashion., Conclusions: We found strong evidence to suggest that discrimination was associated with greater odds of reporting multimorbidity. Future studies can expand on these findings using longitudinal data to capture the relations between discrimination and health over time, or by testing preventive interventions that allay the damaging health effects of discrimination.

Participation of racial/ethnic minority and immigrant populations in research studies is essential to understand and address health disparities. Nonetheless, these populations are often underrepresented in research because of limited participation that may be due to barriers to participation such as fear and mistrust of research, lack of or limited access to healthcare and social services, time and employment constraints, participation-associated costs (e.g., travel costs), language barriers, undocumented status, and cultural differences. Brazilians comprise a rapidly growing immigrant population group in the United States (US), and there is a need to identify and understand factors affecting the health status of Brazilian immigrants that are amenable to intervention. Therefore, this paper presents effective strategies and lessons learned from outreach and recruiting Brazilian immigrants living in the US to enroll in maternal and child health research studies. Using a data recruitment log, we collected quantitative and qualitative data on recruitment strategies that were employed to recruit pregnant women and parents into six health research studies. Direct recruitment strategies included personal contacts of research staff and recruiting partners, and on-site, in-person outreach and recruitment at faith- and community-based events (e.g., meeting participants after church services, at faith-based community events), and private and social events (e.g., household parties) conducted by bilingual, bicultural research assistants who were members of the priority population. We also used snowball sampling as a recruitment strategy by asking enrolled participants to share information about our studies and encourage their family and friends to participate. Indirect recruitment methods included posting flyers at local businesses, social service agencies, faith-based and healthcare organizations, and posting announcements on social media (Facebook). Direct recruitment methods in combination with snowball sampling were the most successful strategies for recruiting Brazilian immigrant parents, while social media was an effective indirect method for recruiting first-time pregnant women. In addition, analyses of qualitative data found that research staff's understanding of the sociocultural context of the target population combined with the use of linguistically and culturally sensitive recruitment strategies tailored to meet the needs of Brazilian immigrants was important for overcoming barriers to participation and facilitating successful recruitment and enrollment of participants. Study findings provide information on a suite of effective strategies and lessons learned for reaching, recruiting, and enrolling Brazilian immigrants in maternal and child health research. Future studies should continue to purposefully collect information on recruitment strategies and disseminate the findings, which will be instrumental in researchers' efforts to increase participation of ethnic minority and immigrant populations such as Brazilians in health research.

Background: Structured, descriptive approaches are utilized by drug regulatory agencies to support and communicate approval decisions about human drugs and biologics. The US Food and Drug Administration (FDA) uses the Benefit-Risk Framework (BRF), which has been integrated into its drug review process. This paper reviews how FDA review teams have used the BRF to communicate approval decisions., Methods: This paper (1) uses content analysis to systematically review the decision factors communicated by FDA review teams in all BRFs associated with novel drugs approved by FDA in 2017-2018 and (2) presents a case study about how the BRF was used for three drugs approved for HIV-1 in 2018-2019., Results: The content analysis found most BRFs for novel drug approvals communicate what we call an "urgent" context and complicating decision factors around benefit and/or risk; the HIV-1 case study highlights the flexibility of the structured BRF tool., Conclusions: FDA's BRF provides a flexible mechanism for communicating important decision factors, allowing it to support the diversity of drug approval decisions made by FDA.