Civil Servant Alarm

Civil servants have long resisted presidential immigration policies. However, bureaucratic by superiors, retaliation against resistance is the norm under the current dministration, despite the fact that this resistance has resulted from principled “dissonance” between civil servants’ understanding of their core responsibilities and the priorities emphasized by new political directives. Rather than condemnation, however, frequent incidents of resistance from divergent factions of the immigration bureaucracy, particularly if met with a harsh response from the President, should be characterized as a “fire alarm” imploring a congressional response

The President\u27s Fourth Branch?

Unitary executive theory has taken hold of the administrative state, motivated by the view that agencies constitute a rogue fourth branch of government. Emboldened by the U.S. Supreme Court, the President has begun to interfere with administrative accountability to important criteria including statutory procedural requirements that impact both public participation and administrative due process, the expectation that agencies engage neutral expertise to implement the law, and the obligations of judicial review. As a result, this Essay argues, rather than constituting a fourth branch that is unaccountable to the President, the administrative state has been encouraged by the President and courts to become unaccountable to Congress. It is possible, however, that congressional and judicial oversight and intervention could encourage administration that is more consistent both with legislative mandates and norms that legitimate the administrative state

Interagency Transfers of Adjudication Authority

Agencies sometimes give away their legislatively delegated decision­making power of their own accord . More specifically, agencies make agreements in order to transfer their entire jurisdiction to adjudicate administrative decisions to other agencies. This Article is the first to explore these mostly informal, endogenous interagency arrangements

Judicial Administration

“Presidential administration” has been discussed for the last twenty years. However, scholars have not considered whether courts are doing the same thing. Like presidents, courts may oversee the quality of administrative action under authority granted by the Constitution and legislation. And also, like presidents, courts make policy decisions in lieu of the agency that has been delegated policymaking power. This Article draws on case law and legal scholarship, as well as work from public administration and political science, to construct a paradigm of “judicial administration.” More specifically, it offers a history of and traces the tension between the “overseer” and “decider” approaches to judicial administration. In addition, it explains the implications of these approaches for the constitutionality and efficacy of judicial review today. First, this Article considers judicial administration as accomplished through the reinforcement of administrative procedure. These efforts were criticized as judicial policymaking by formalists. However, as this Article notes, these decisions focus on reconciling administrative action with constitutional, technical, and rule-of-law norms and are thus rooted in overseer impulses. In other words, the decider dimensions of even the most intrusive judicial review of agency process have been overstated. Second, and in contrast, this Article notes that the recent call to overturn Chevron constitutes uncritical advocacy for the decider approach to the judicial administration of statutory directives. In the past, courts have limited their role in the administration of legislation to that of overseer. However, today’s formalists seek to implement de novo review wholesale. This effort is, at its core, a push for courts to decide policy in lieu of the agencies to which Congress has delegated policymaking power or to which policymaking power belongs as a matter of executive authority. This may not trouble functionalists much. But it should trouble the very formalists who denounce Chevron. First, this evinces an inconsistency in their position, given that many have condemned what they identify as judicial policymaking in administrative process. More broadly, as in presidential administration, the decider approach to judicial administration runs the risk of treading on the legislature’s authority to make the law. To the extent this is the case, calls to dismantle the administrative state and instate the judiciary in its place are focused on reimbursing the wrong branch of government. For those interested in judicial intervention as a means of regulating the administrative state, including the exercise of presidential power, the overseer model of judicial administration is less likely to offend a formal conception of the separation of powers. Furthermore, longstanding paradigms of judiciary as overseer confront the pressing issues—namely, the denigration of administrative due process and corrosion of expertise in service of the President’s agenda—resulting from today’s unsupervised executive branch

Exploring the Impact of Influensive factors of Corporate Social Responsibility on Organic Farming with Reference to Mehsana and Khambhat District of Gujarat State

This study delved into the relationship between Corporate Social Responsibility (CSR) and organic farming, specifically focusing on Mehsana and Khambhat districts in Gujarat, India. The research explores the impact of influential factors associated with CSR initiatives on the perspectives and practices of farmers. The study adopts a descriptive cross-sectional research design, employing a non-probabilistic convenient sampling technique with a sample size of 100 farmers. Data analysis is conducted using non-parametric tests, namely the Mann Whitney U test and Kruskal Wallis Test. These statistical tools are selected to accommodate the non-normal distribution of data and provide robust insights into the perceived impact of CSR on organic farming practices. The choice of a non-probabilistic convenient sampling approach acknowledges practical constraints while aiming to capture a representative snapshot of the farming community in the selected districts. The findings revealed that farmers, across various socio-demographic profiles, exhibit diverse opinions regarding the crucial factors constituting CSR that significantly influence organic farming. Through the application of Mann Whitney U test and Kruskal Wallis Test, the study identified differences in perceptions among farmers based on factors such as gender, age, educational qualification, annual income, and occupation. The outcomes highlighted the importance of tailoring CSR initiatives to suit the diverse needs and perspectives of farmers in Mehsana and Khambhat districts

Two-year follow-up of KTE-X19 in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia in ZUMA-3 and its contextualization with SCHOLAR-3, an external historical control study

BACKGROUND: Brexucabtagene autoleucel (KTE-X19) is an autologous anti-CD19 CAR T-cell therapy approved in the USA to treat adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (R/R B-ALL) based on ZUMA-3 study results. We report updated ZUMA-3 outcomes with longer follow-up and an extended data set along with contextualization of outcomes to historical standard of care. METHODS: Adults with R/R B-ALL received a single infusion of KTE-X19 (1 × 10 RESULTS: After 26.8-months median follow-up, the overall complete remission (CR) rate (CR + CR with incomplete hematological recovery) among treated patients (N = 55) in phase 2 was 71% (56% CR rate); medians for duration of remission and overall survival (OS) were 14.6 and 25.4 months, respectively. Most patients responded to KTE-X19 regardless of age or baseline bone marrow blast percentage, but less so in patients with \u3e 75% blasts. No new safety signals were observed. Similar outcomes were observed in a pooled analysis of phase 1 and 2 patients (N = 78). In SCHOLAR-3, the median OS for treated patients from ZUMA-3 (N = 49) and matched historical controls (N = 40) was 25.4 and 5.5 months, respectively. CONCLUSIONS: These data, representing the longest follow-up of CAR T-cell therapy in a multicenter study of adult R/R B-ALL, suggest that KTE-X19 provides a clinically meaningful survival benefit with manageable toxicity in this population. TRIAL REGISTRATION: NCT02614066

Evaluation of second-generation liquid-based cytology system for the detection of cervical abnormality

Liquid-based cytology (LBC) has replaced conventional smears in the UK. The National Institute for Health and Clinical Excellence (NICE) recommended the use of LBC in 2003. ThinPrepTM (TP) and SurePathTM (SP) LBC systems were adopted for use in the National Health Service Cervical Screening Programme (NHSCSP) in the UK. NICE recommended further review of any other technologies or other liquid-based cytology systems in the future. For any second-generation LBC systems to be considered for cervical screening in the NHSCSP, there must be an evaluation of technical requirements and clinical data relating to their sensitivity, specificity and the percentage of inadequate samples.The objective of the work undertaken for this thesis was to provide evidence to enable an informed decision on the use of second-generation liquid-based cytology systems for cervical screening in the UK. The decision to accept the second-generation LBC system in the NHSCSP is based on its reliability, clinical effectiveness and cost implications. This work will determine the reliability, microscopic quality and reproducibility of slides of the second-generation LBC system, and the results of this work will form the platform for progression to the clinical evaluation of the system.Initially, four second-generation LBC systems were considered suitable for evaluation. They were Seroa CYTO-screen, Shandon Papspin, LGM Liqui-PREP and CellSolution 120. However, the specifications of only one system (CellSolution 120TM) met NHSCSP technical requirements to start the evaluation. One hundred random, electronically generated colposcopy patient samples were used to assess the technical reliability of the CellSolution 120TM system. The technical evaluation consisted of pre-phase I and phase I. The results of these phases will decide whether the CS 120TM liquid-based cytology system could be carried further for clinical evaluation (phase II) or not.This study was sponsored by the NHS Purchasing and Supply Agency (PASA), the Centre for Evidence based Purchasing (CEP) on behalf of the NHSCSP. The Manchester Cytology Centre (MCC) was selected as the site for evaluation of CellSolution 120™ and the project was managed by Guildford Medical Device Evaluation Centre (GMEC) on behalf of CEP.EThOS - Electronic Theses Online ServiceCentre for Evidence Based PurchasingGBUnited Kingdo

Association of ABC (HbA1c, Blood Pressure, LDL-Cholesterol) Goal Attainment with Depression and Health-Related Quality of Life among Adults with Type 2 Diabetes

Aims: To determine the relationship between ABC goal attainment, depression, and health-related quality of life (HRQoL) among a national sample of patients with type 2 diabetes (T2DM). Methods: A retrospective, cross-sectional analysis was performed examining 808 non-pregnant patients ≥ 20 years old with T2DM from the National Health and Nutrition Examination Survey (NHANES) 2007-2012. ABC goals were defined as HbA1c \u3c 7%, BP \u3c 130/80mmHg, and LDL-C \u3c 100mg/dL. Patient characteristics associated with ABC goal attainment were examined. Results: Overall, 23.7% of participants achieved simultaneous ABC goals. Severe depression was significantly associated with lower rates of ABC goal attainment compared to those with no depression (5.0% vs. 25.4%, p = 0.048). ABC goal attainment rates were lower among females, Hispanic and non-Hispanic Black minority groups, and patients with a duration of diabetes over five years, while increased visits with health care professionals was significantly associated with meeting all three ABC goals for patients with T2DM. Conclusions: The relationship between simultaneous ABC goal attainment, depression and HRQoL is complex. Patients with T2DM unable to meet ABC goals may benefit from increased contact with health care professionals

Real-World Usage and Clinical Outcomes of Alectinib Among Post-Crizotinib Progression Anaplastic Lymphoma Kinase Positive Non-Small-Cell Lung Cancer Patients in the USA

Background: Alectinib is an approved treatment for anaplastic lymphoma kinase (ALK)-positive patients with advanced non-small-cell lung cancer. Despite positive supporting clinical data, there is a lack of real-world information on the usage and patient outcomes of those treated with alectinib post-crizotinib progression. Methods: Participating oncologists (N=95) in the USA were recruited from an online physician panel to participate in a retrospective patient chart review. Physicians randomly selected eligible patients (ie, patients who progressed on crizotinib as their first ALK inhibitor and were treated with alectinib as their second ALK inhibitor), collected demographics and clinical history from their medical charts, and entered the data into an online data collection form. Results: A total of N=207 patient charts were included (age: 60.1±10.4 years; 53.6% male). The patients in our sample were older (median age of 60 vs 53 years), were more likely to be current smokers (12% vs 1%), had better performance status (45% vs 33% had an Eastern Cooperative Oncology Group [ECOG] of 0), and were less likely to have an adenocarcinoma histology (83% vs 96%) relative to published clinical trials. The objective response rate was higher than in clinical trials (67.1% vs 51.3%, respectively) as was the disease control rate (89.9% vs 78.8%, respectively), though it varied by race/ethnicity, ECOG, and prior treatment history. Discontinuation (0.0%) and dose reductions (3.4%) due to adverse events were uncommon in alectinib. Conclusion: Patients using alectinib post-crizotinib in clinical practice are older, more racially/ethnically and histologically diverse than patients in published trials. Real-world response rates were high and similar to those reported in clinical studies, though there is some variation by patient characteristics. Alectinib was well tolerated in clinical practice as reflected by the rates of discontinuation, dose reductions, and dose interruptions