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    Green tea extracts containing epigallocatechin-3-gallate modulate facial development in Down syndrome
    (Springer Nature, 2021-02-25) Starbuck, John M.; Llambrich, Sergi; Gonzàlez, Rubèn; Albaigès, Julia; Sarlé, Anna; Wouters, Jens; González, Alejandro; Sevillano, Xavier; Sharpe, James; De La Torre, Rafael; Dierssen, Mara; Vande Velde, Greetje; Martínez‑Abadías, Neus; Robert H. McKinney School of Law
    Trisomy of human chromosome 21 (Down syndrome, DS) alters development of multiple organ systems, including the face and underlying skeleton. Besides causing stigmata, these facial dysmorphologies can impair vital functions such as hearing, breathing, mastication, and health. To investigate the therapeutic potential of green tea extracts containing epigallocatechin-3-gallate (GTE-EGCG) for alleviating facial dysmorphologies associated with DS, we performed an experimental study with continued pre- and postnatal treatment with two doses of GTE-EGCG supplementation in a mouse model of DS, and an observational study of children with DS whose parents administered EGCG as a green tea supplement. We evaluated the effect of high (100 mg/kg/day) or low doses (30 mg/kg/day) of GTE-EGCG, administered from embryonic day 9 to post-natal day 29, on the facial skeletal development in the Ts65Dn mouse model. In a cross-sectional observational study, we assessed the facial shape in DS and evaluated the effects of self-medication with green tea extracts in children from 0 to 18 years old. The main outcomes are 3D quantitative morphometric measures of the face, acquired either with micro-computed tomography (animal study) or photogrammetry (human study). The lowest experimentally tested GTE-EGCG dose improved the facial skeleton morphology in a mouse model of DS. In humans, GTE-EGCG supplementation was associated with reduced facial dysmorphology in children with DS when treatment was administered during the first 3 years of life. However, higher GTE-EGCG dosing disrupted normal development and increased facial dysmorphology in both trisomic and euploid mice. We conclude that GTE-EGCG modulates facial development with dose-dependent effects. Considering the potentially detrimental effects observed in mice, the therapeutic relevance of controlled GTE-EGCG administration towards reducing facial dysmorphology in young children with Down syndrome has yet to be confirmed by clinical studies.
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    An ethics framework for consolidating and prioritizing COVID-19 clinical trials
    (Sage, 2021) Meyer, Michelle N.; Gelinas, Luke; Bierer, Barbara E.; Chandros Hull, Sara; Joffe, Steven; Magnus, David; Mohapatra, Seema; Sharp, Richard R.; Spector-Bagdady, Kayte; Sugarman, Jeremy; Wilfond, Benjamin S.; Fernandez Lynch, Holly; Robert H. McKinney School of Law
    Given the dearth of established safe and effective interventions to respond to COVID-19, there is an urgent ethical imperative to conduct meaningful clinical research. The good news is that interventions to be tested are not in short supply. Unfortunately, the human and material resources needed to conduct these trials are finite. It is essential that trials be robust and meet enrollment targets and that lower-quality studies not be permitted to displace higher-quality studies, delaying answers to critical questions. Yet, with few exceptions, existing research review bodies and processes are not designed to ensure these conditions are satisfied. To meet this challenge, we offer guidance for research institutions about how to ethically consolidate and prioritize COVID-19 clinical trials, while recognizing that consolidation and prioritization should also take place upstream (among manufacturers and funders) and at a higher level (e.g., nationally). In our proposed three-stage process, trials must first meet threshold criteria. Those that do are evaluated in a second stage to determine whether the institution has sufficient capacity to support all proposed trials. If it does not, the third stage entails evaluating studies against two additional sets of comparative prioritization criteria: those specific to the study and those that aim to advance diversification of an institution’s research portfolio. To implement these criteria fairly, we propose that research institutions form COVID-19 research prioritization committees. We briefly discuss some important attributes of these committees, drawing on the authors’ experiences at our respective institutions. Although we focus on clinical trials of COVID-19 therapeutics, our guidance should prove useful for other kinds of COVID-19 research, as well as non-pandemic research, which can raise similar challenges due to the scarcity of research resources.
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    The Journey of a Teacher
    (2007) Gilgoff, Julie
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    Opportunity To Purchase Policies: Preserving the Affordability of Manufactured Home Communities
    (2023-09-02) Gilgoff, Julie
    “Manufactured homes,” otherwise known as “mobile homes,” are one of the last vestiges of truly affordable housing in the United States. With funding drying up for government-subsidized rental programs, manufactured homes are an attractive form of naturally occurring affordable housing that enable low-income communities to attain homeownership an build equity. Manufactured home owners are simultaneously owners and renters. Although they own their homes, they rent the land underneath, and remain vulnerable to eviction. Manufactured homes are no longer mobile, and once the structure is placed on a lot and hooked up to plumbing, it is nearly impossible to move. Many residents of manufactured housing communities live on fixed-incomes and cannot afford the rent spikes that are now commonplace when park ownership switches from individual landlord to corporate ownership. When rent increases, many tenants have no choice but to abandon their homes. Landlords do not experience a loss of rental income because they can find a replacement tenant willing to live in the abandoned home. Opportunity to Purchase (OTP) policies hold the potential to stop this cycle. OTP policies require park owners to provide residents notice when they intend to sell the park. Landlords must allow tenants to make a bid, and in some states, are required to accept the residents’ bid on the park if tenants are able to match the best and final offer. OTP policies must be swiftly adopted, but advocates and policymakers remain fearful of legal challenges under the Takings Clause. Two lower court rulings have held that OTP policies take private property without just compensation because of the policy’s infringement of the owner’s right to dispose or sell the property to a party of their choosing. The “essentialist” rationale of these and other courts, upholding a single property right as fundamental, and therefore impenetrable, is fundamentally flawed. At a time when an essentialist application of the Fifth Amendment threatens any policy that challenges the status quo, a more integrated view of property rights must be utilized by courts to safeguard OTP and other policies from takings challenges.
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    Land Redistribution in the Aftermath of the COVID-19 Pandemic
    (2022) Gilgoff, Julie
    As the United States begins to emerge from the COVID-19 pandemic, there is a glaring need to redefine property law. Many who are concerned about the looming eviction and homelessness crisis are calling for policies that preserve "naturally occurring affordable housing" before they are sold to private developers and converted to market rate rentals. This Article explores policies that preserve affordable housing and redistribute surplus vacant properties to those in need. Property theories that justify government-sponsored land redistribution assert that redistribution is necessary when the property system fails to provide a meaningful opportunity for the majority to own and enjoy adequate housing. In the midst of an unprecedented surge of homelessness that is sure to follow the lifting of eviction moratoria, this Article posits that self-help measures such as urban squatting should be tolerated in the absence of policies that achieve redistributive results. Historical examples of the legislature intervening to create redistributive policies, and to support squatter movements that defy property law, help support the conclusion that radical property reform is justified at this unique juncture, just as it was at various times since the founding of the United States.
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    Pandemic-Related Vacant Property Initiatives
    (2020) Gilgoff, Julie
    With the rapid spread of COVID-19 in homeless shelters across the country, policies that provide socially distanced housing for society's most vulnerable have been widely implemented. Hotels-that would have sat vacant while the economy was shut down-were temporarily repurposed to house the homeless. Once COVID-19 pandemic became an ongoing, rather than a short-term health crisis, governments began working to find longer-term housing solutions, like the ones featured in this article.
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    Disaggregation of Public Health Data by Race & Ethnicity: A Legal Handbook
    (Network for Public Health Law, 2022-12) Hoss, Aila; Murphy, Stephen; Sanchez, Emely; Waggoner, Carrie
    This handbook addresses the role of law in collecting and disseminating public health data disaggregated by race and ethnicity for public health practitioners and attorneys across state, Tribal, and local governments. It is intended to assist practitioners and attorneys with framing and navigating the various legal and non-legal issues around disaggregated public health data. Data disaggregation is the breakdown and categorization of large sets of data by certain data elements, such as race and ethnicity.