Understanding individualised genetic interventions as research-treatment hybrids.

Until recently, medicine has had little to offer most of the millions of patients suffering from rare and ultrarare genetic conditions. But the development in 2019 of Milasen, the first genetic intervention developed for and administered to a single patient suffering from an ultrarare genetic disorder, has offered hope to patients and families. In addition, Milasen raised a series of conceptual and ethical questions about how individualised genetic interventions should be developed, assessed for safety and efficacy and financially supported. The answers to these questions depend in large part on whether individualised therapies are understood as human subjects research or clinical innovation, different domains of biomedicine that are regulated by different modes of oversight, funding and professional norms. In this article, with development and administration of the drug Milasen as our case study, we argue that at least some individualised genetic therapies are not, as some have argued, either research or treatment. Instead, they are research-treatment hybrids, a category that has both epistemological and pragmatic repercussions for funding, ethics oversight and regulation.

Enacting Relational Public Health: Federally Qualified Health Centers During the COVID-19 Pandemic.

Federally Qualified Health Centers (FQHCs) proved to be critical points of access for people of color and other underserved populations during the COVID-19 pandemic, administering 61% of their COVID-19 vaccinations to people of color, compared to the 40% rate for the overall United States' vaccination effort. To better understand the approaches and outcomes of FQHCs in pandemic response, we conducted semi-structured interviews with FQHC health care providers and outreach workers and analyzed them using an inductive qualitative methodology.

"We're Here to Take Care of Our Community": Lessons Learned From the U.S. Federal Health Center Covid-19 Vaccine Program.

Equitable access to vaccination is crucial to mitigating the disproportionate impact of Covid-19 on low-income communities and people of color in the United States. As primary care clinics for medically underserved patients, Federally Qualified Health Centers (FQHCs) emerged as a success story in the national effort to vaccinate the U.S. public against Covid-19. In February 2021, the Federal Health Center Covid-19 Vaccine Program began allocating vaccine supply directly to FQHCs in an effort to improve vaccine equity. This qualitative study documents how FQHCs in two states successfully mitigated barriers to vaccine access, responded to patient concerns about vaccination, and worked to maintain and grow community trust in a climate of uncertainty and fear during early vaccine roll-out to the general population. Using a socio-ecological model, we show how FQHCs intervened at multiple levels to advance vaccine equity, revealing valuable lessons for health promotion practice in primary care settings or underserved communities. Our findings provide descriptive context for existing quantitative evidence showing FQHCs' greater success in vaccinating people of color, and foreground valuable and innovative strategies for trustworthy health communication practices and equitable resource allocation to medically underserved patients and populations.

Abortion Miscoding-Legal Risks for Clinicians and Hospital Systems.

This Viewpoint discusses the legal risks physicians and health care facilities may incur by miscoding a surgical or chemical abortion as a miscarriage to conceal an abortion procedure.

All of Us and the Promise of Precision Medicine: Achieving Equitable Access for Federally Qualified Health Center Patients.

The United States National Institutes of Health's (NIH) All of Us (AoU) initiative recruits participants from diverse backgrounds to improve the makeup of biobanks, considering nearly all biospecimens used in research come from people of European ancestry. Participants who join AoU consent to provide samples of blood, urine, and/or saliva and to submit their electronic health record to the program. In addition to diversifying precision medicine research studies, AoU will return genetic results back to many participants, which may require further follow-up care (i.e., more frequent cancer screening or mastectomy after a BRCA result). To help achieve its goals, AoU has partnered with Federally Qualified Health Centers (FQHCs), which is a type of community health center whose patient base is comprised largely of people who are uninsured, underinsured, or on Medicaid. Our NIH-funded study convened FQHC providers involved in AoU to better understand precision medicine in community health settings. Drawing from our findings, we present barriers community health patients and their providers face when accessing diagnostics and specialty care after genetic results necessitate medical follow-up care. We also propose several policy and financial recommendations to help overcome the challenges discussed, stemming from a commitment to equitable access to precision medicine advances.

Crisis Pregnancy Centers: An Inherently Unjust Limitation to Reproductive Rights.

Abortion, though afforded certain legal protections, can be challenging to access in many areas of the United States, a problem exacerbated by the presence of Crisis Pregnancy Centers (CPCs). CPCs present themselves as clinics that provide a full spectrum of free pregnancy consultation services, but in fact are pro-life, anti-abortion organizations.1 From the outside, CPCs appear to be neutral health and welfare establishments, leading women *to believe they will receive unbiased guidance based on their best interests. In reality, CPCs recruit unsuspecting women into their facilities to deter them from accessing abortions, promoting only two options: parenthood or adoption.2 Women are lured into CPCs with the promise of free services which range from medical care to clothing and other items. At its most basic level, these deceptive practices violate the autonomy of women seeking reproductive care, perpetuating unjust limitation of access to quality medical care.