Genetics and COVID-19: How to Protect the Susceptible.

Along with the potential for breakthroughs in care and prevention, the search for genetic mechanisms underlying the spread and severity of coronavirus disease 2019 (COVID-19) introduces the risk of discrimination against those found to have markers for susceptibility. We propose new legal protections to mitigate gaps in protections under existing laws.

Demographic diversity of genetic databases used in Alzheimer's disease research.

For several years, experts have warned about the lack of diversity in genetic research databases, and researchers have devoted time and resources to recruiting subjects from underrepresented subgroups. In this study, we review published reports in academic journals of genetic studies of Alzheimer's disease to note whether demographic diversity was indicated in the reports and, if so, the extent of representation of non-European subjects over the period from 1997 to 2022. We use multivariate regression analysis to analyze changes over time and to explain variation across studies. Our analysis indicates that reported diversity has not changed over time. Rather, it appears to have remained relatively constant, since Genome-Wide Association Studies (GWASs) were first used in the 1990s. We find most variation to be across journals rather than within journals, suggesting that characteristics of journals are an important influence on the dissemination of research with diverse samples. Lack of racial diversity in genetic databases used to develop clinical applications could lead to disparities in the effectiveness of those applications for underrepresented groups.

The Impact of Law on Syndromic Disease Surveillance Implementation.

CONTEXT: Legal environments influence how health information technologies are implemented in public health practice settings. Syndromic disease surveillance (SyS) is a relatively new approach to surveillance that depends heavily on health information technologies to achieve rapid awareness of disease trends. Evidence suggests that legal concerns have impeded the optimization of SyS. OBJECTIVES: To (1) understand the legal environments in which SyS is implemented, (2) determine the perceived legal basis for SyS, and (3) identify perceived legal barriers and facilitators to SyS implementation. DESIGN: Multisite case study in which 35 key informant interviews and 5 focus groups were conducted with 75 SyS stakeholders. Interviews and focus groups were audio recorded, transcribed, and analyzed by 3 coders using thematic content analysis. Legal documents were reviewed. SETTING: Seven jurisdictions (5 states, 1 county, and 1 city) that were purposively selected on the basis of SyS capacity and legal environment. PARTICIPANTS: Health department directors, SyS system administrators, legal counsel, and hospital personnel. RESULTS: Federal (eg, HIPAA) and state (eg, notifiable disease reporting) laws that authorize traditional public health surveillance were perceived as providing a legal basis for SyS. Financial incentives for hospitals to satisfy Meaningful Use regulations have eased concerns about the legality of SyS and increased the number of hospitals reporting SyS data. Legal issues were perceived as barriers to BioSense 2.0 (the federal SyS program) participation but were surmountable. CONCLUSION: Major legal reforms are not needed to promote more widespread use of SyS. The current legal environment is perceived by health department and hospital officials as providing a firm basis for SyS practice. This is a shift from how law was perceived when SyS adoption began and has policy implications because it indicates that major legal reforms are not needed to promote more widespread use of the technology. Beyond SyS, our study suggests that federal monetary incentives can ameliorate legal concerns regarding novel health information technologies.

Neighborhood Socioeconomic Status and Primary Health Care: Usual Points of Access and Temporal Trends in a Major US Urban Area.

Neighborhood socioeconomic status (SES), an overall marker of neighborhood conditions, may determine residents' access to health care, independently of their own individual characteristics. It remains unclear, however, how the distinct settings where individuals seek care vary by neighborhood SES, particularly in US urban areas. With existing literature being relatively old, revealing how these associations might have changed in recent years is also timely in this US health care reform era. Using data on the Philadelphia region from 2002 to 2012, we performed multilevel analysis to examine the associations of neighborhood SES (measured as census tract median household income) with access to usual sources of primary care (physician offices, community health centers, and hospital outpatient clinics). We found no evidence that residence in a low-income (versus high-income) neighborhood was associated with poorer overall access. However, low-income neighborhood residence was associated with less reliance on physician offices [-4.40 percentage points; 95 % confidence intervals (CI) -5.80, -3.00] and greater reliance on the safety net provided by health centers [2.08; 95 % CI 1.42, 2.75] and outpatient clinics [1.61; 95 % CI 0.97, 2.26]. These patterns largely persisted over the 10 years investigated. These findings suggest that safety-net providers have continued to play an important role in ensuring access to primary care in urban, low-income communities, further underscoring the importance of supporting a strong safety net to ensure equitable access to care regardless of place of residence.

An education in contrast: state-by-state assessment of school immunization records requirements.

OBJECTIVES: We reviewed the complexities of school-related immunization policies, their relation to immunization information systems (IIS) and immunization registries, and the historical context to better understand this convoluted policy system. METHODS: We used legal databases (Lexis-Nexis and Westlaw) to identify school immunization records policies for 50 states, 5 cities, and the District of Columbia (Centers for Disease Control and Prevention "grantees"). The original search took place from May to September 2010 (cross-referenced in July 2013 with the list on http://www.immunize.org/laws ). We describe the requirements, agreement with IIS policies, and penalties for policy violations. RESULTS: We found a complex web of public health, medical, and education-directed policies, which complicates immunization data sharing. Most (79%) require records of immunizations for children to attend school or for a child-care institution licensure, but only a few (11%) require coordination between IIS and schools or child-care facilities. CONCLUSIONS: To realize the full benefit of IIS investment, including improved immunization and school health program efficiencies, IIS and school immunization records policies must be better coordinated. States with well-integrated policies may serve as models for effective harmonization.

Assessment of Resident Physician Comfort in Screening for Social Determinants of Health in a Specialty Clinic Population.

Through qualitative surveys, a team of law students, law professors, physicians, and residents explored the perceptions of neurology residents towards referral to appropriate legal resources in an academic training program. Respondents reported feeling uncomfortable screening their patients for health-harming legal needs, which many attributed to a lack of training in this area. These findings indicate that neurology residents would benefit from training on screening for social factors that may be impacting their patients' health.

How to Motivate Equity in Health Decision Modeling.

American health care is rife with inequity in access to services. Even among people with insurance, inequity can result from insurers' decisions about which services to cover. These decisions are often based on economic models that are seemingly objective but neglect factors affecting people who are economically disadvantaged. Laws and government programs designed to mitigate inequities in access have limited value in addressing bias in models that inform coverage decisions. As a reform, government agencies that fund research could require that studies on which decision models are based better account for factors affecting people who are economically disadvantaged, an approach this article explores.

Measuring the COVID-19 Financial Threat to Hospital Markets.

Many hospitals have been straining under the financial stress of treating COVID-19 patients. Those experiencing the greatest strain are in markets burdened with high levels of debt and uncompensated care. We propose a new measure of financial risk in a hospital market, combining both pre-existing financial vulnerability and COVID-19 severity. It reveals the highest concentrations of risk in counties with high poverty, low population density, and high shares of foreign-born and non-White populations. The CARES Act Provider Relief Fund helped many of the hospitals in these regions, but it left many markets with the same overall vulnerability to financial strain from the next health crisis.

Can governments push providers to collaborate? A comparison of hospital network reforms in France and the United States.

France recently implemented a program to encourage greater collaboration among public hospitals, which represent about 65 percent of total capacity, by placing them into regional groupings known as Groupements Hospitalier Territoire (GHTs) and mandating that facilities within them share several core functions. The strategy echoes that of Accountable Care Organizations (ACOs) in the United States, which offer financial incentives to providers to form networks that foster collaboration. While the programs share an underlying strategy for improving care and reducing costs, the difference in approaches, mandatory versus voluntary, could significantly affect outcomes. We analyzed aspects of the programs that could lead to differences in their results. ACOs appear to have several advantages, as financial inducements have proven effective in shaping provider behavior in other contexts. GHTs may benefit from a more direct approach, but mandatory participation risks pushback. Regardless of whether the programs succeed in fostering effective care integration, they may accelerate provider consolidation, which could impair access in already underserved areas by concentrating resources in larger facilities and promoting the closure of smaller ones.

Pediatricians' vaccine attitudes and practices before and after a major measles outbreak.

The objective of this study was to describe how a sample of pediatricians were impacted by and responded to the Disneyland measles outbreak in the United States. We conducted three repeated cross-sectional, online surveys in 2014 (before the outbreak), 2015, and 2016 (after the outbreak) among members of three state chapters of the American Academy of Pediatrics. We assessed pediatricians' level of willingness and length of time comfortable delaying the measles-mumps-rubella (MMR) vaccine before and after the outbreak. Frequency of alternative immunization schedule requests and creation of office immunization policies due to the outbreak were measured. The sample included 304 pediatricians in 2014, 270 in 2015, and 221 in 2016. We found no significant changes in willingness or comfort delaying the MMR vaccine before and after the outbreak. In 2015, 38% of pediatricians reported fewer requests for alternative immunization schedules and 20% created stricter office immunization policies. A subsample of pediatricians reported administering the MMR vaccine earlier in the recommended time frame and taking extra precautions in waiting rooms due to the outbreak. Our results suggest that this measles outbreak did not lead to significant changes in attitudes or practices among this sample, but did modestly affect office immunization policies and practices.

A proposed ethical framework for vaccine mandates: competing values and the case of HPV.

Debates over vaccine mandates raise intense emotions, as reflected in the current controversy over whether to mandate the vaccine against human papilloma virus (HPV), the virus that can cause cervical cancer. Public health ethics so far has failed to facilitate meaningful dialogue between the opposing sides. When stripped of its emotional charge, the debate can be framed as a contest between competing ethical values. This framework can be conceptualized graphically as a conflict between autonomy on the one hand, which militates against government intrusion, and beneficence, utilitarianism, justice, and nonmaleficence on the other, which may lend support to intervention. When applied to the HPV vaccine, this framework would support a mandate based on utilitarianism, if certain conditions are met and if herd immunity is a realistic objective.

Factors Associated With Pediatrician Responses to Alternative Immunization Schedule Requests.

We conducted a cross-sectional online survey among 4 chapters of the American Academy of Pediatrics from July through October 2014 to describe characteristics of pediatricians and practices associated with practice-level responses to alternative immunization schedule requests. Among 374 pediatricians, 58% reported frequent alternative immunization schedule requests and 24% reported feeling comfortable using them. Pediatricians who work in practices that accommodate alternative immunization schedule requests have increased odds of having a high frequency of alternative immunization schedule requests, and beliefs that relationships with families would be negatively affected if they refused requests. Practices that discontinue care to families who request alternative immunization schedules have increased odds of being a private group practice and having a formal office vaccine policy. Pediatricians are frequently asked to use alternative immunization schedules and many are not comfortable using them. Practice-level responses to alternative immunization schedules are associated with characteristics of pediatricians and practices.

Regulation of homeopathic drug products.

PURPOSE: The regulation of homeopathic drug products is discussed. SUMMARY: Homeopathy is a system of medicine based on the observation that high doses of pharmacologically active substances cause symptoms when administered to healthy individuals. These same substances, when prepared in very dilute form, may relieve similar symptoms in conditions resulting from different etiologies. Unlike dietary supplements, homeopathic drugs are subject to the Food, Drug, and Cosmetic Act and regulations issued by FDA. Instead of the new-drug-approval process, premarket approval for homeopathic drugs is by way of monograph approval by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). Monographs are published in the Homeopathic Pharmacopoeia of the United States (HPUS). The criteria for inclusion in the HPUS require that a homeopathic drug product be determined by HPCUS to be safe and effective and to be prepared according to the specifications of the HPUS general pharmacy section. The long history and established nature of homeopathic drug regulation may provide a model for the regulation of dietary supplements. CONCLUSION: Homeopathic drugs in the United States are subject to well-defined regulatory processes that more closely resemble those that apply to allopathic medications than to dietary supplements.

Toward a policy agenda on medical research funding: results of a symposium.

University of the Sciences in Philadelphia convened a symposium to discuss the roles of government, industry, and foundations in funding biomedical research. Government, no longer the largest funder of biomedical research, focuses on basic science. The pharmaceutical industry, now the largest sponsor, focuses on developing and testing new products. Foundations play a unique role in their ability to fund research overlooked by the other sectors. However, gaps remain in this infrastructure. Barriers, including lack of qualified investigators and administrative burdens, constrain discovery. Funders should collaborate to address these constraints and stimulate new sources of funding.