“Right to Try” Legislation and Its Implications for the FDA Drug Approval Process

This note analyzes the regulation of experimental drugs by the FDA within the context of “right-to-try” laws. Hogan explores the FDA’s drug approval process, highlighting the specific options for terminally ill patients to fast-track their access to potentially life-saving drugs. Hogan then turns to state “right-to-try” laws, addressing them in relation to federal preemption, pharmaceutical companies, and actual assistance to terminally ill patients. Hogan recommends a relaxation of the FDA’s drug approval process, specifically streamlining the “expanded access” program to give terminally ill patients access to experimental drugs

Building Knowledge Across the Curriculum: Utilizing the Learning Community Model to Maximize Relevant Information Literacy Instruction

This session will focus on the collaborative efforts of the librarians at this Community College and their proposed course in information literacy designed to teach research methods within specific majors. The course was created to act as a sort of “lab†for a foundational course in the disciplines that will focus on research methods utilized in those academic areas. For example, the course could be paired with a foundational sociology course and would focus on the research methods in that field. Or, it could be paired with a history course, where students would learn research methods in that field. The course would include bringing in the college writing center in order to teach students to write within their chosen field, as well as feature guest lecturers who have conducted research and can ask questions about interviewing, data collection, and other facets of research. The course is based on the High Impact Practice (HIP) of a learning community. The course will be offered as part of the required college first-year curriculum but will specifically be tailored to declared majors. The course, as a part of a learning community, would teach to the research assignments that are assigned in its partner course. In doing so, the students will be able to gain the research skills and support required to complete assigned research assignments

Lives in Limbo: How the Boston Asylum Office Fails Asylum Seekers

The process of seeking asylum in the United States is long and fraught with stress and hardship. But asylum seekers who apply through the Boston Asylum Office face a unique challenge: an asylum grant rate that is well below the national average. From 2015 to 2020, the Boston Asylum Office, on average, granted a mere 15 percent of asylum applications, with some months granting as low as 1.5 percent of asylum seekers. In contrast, the national average grant rate was nearly twice as high: 28 percent.This trend worsened following the election of former President Donald Trump. In Fiscal Year (FY) 2021, the Boston Asylum Office reported a grant rate of a mere 11 percent, while the national average was 27 percent. The Boston Asylum Office has failed to adequately explain why its grant rate has remained far below that of the national average. The result of this disproportionately low grant rate is that people fleeing persecution in their home countries are wrongly denied asylum and the protections afforded to them by international and U.S. law. Asylum seekers may ultimately have to wait years for their cases to be resolved. During this time, they are separated from their family members abroad who often remain in danger. All of this compounds stress and trauma on individuals who have already fled persecution.This report, which was compiled by analyzing documents produced by U.S. Citizenship and Immigration Services (USCIS) in response to a FOIA request, and interviews of asylees, asylum seekers, immigration attorneys, asylum officers (AOs), and supervisory asylum officers (SAOs), seeks to answer the fundamental question: Why does the Boston Asylum Office approve such a small percentage of asylum cases

Constipation in the Long-Term Care Resident

An evidence-based clinical practice guideline was developed to prevent and manage constipation in the long-term care (LTC) resident. Constipation is a prevalent condition in the LTC resident. Guidelines do not address this vulnerable population. Constipation may result in poor nutritional status, quality of life along with increased health care costs and hospitalizations. A literature review was completed and evidence was evaluated and included into the initial draft recommendations. The guideline was reviewed for content validity using a Delphi Committee of clinical experts in gastroenterology, geriatrics, and pharmacy. The updated guidelines were presented to an interdisciplinary team of long-term care residents. Participants were asked to review and complete a survey regarding clinical applicability of the guideline. Thirty-one interdisciplinary members participated in the education session and 30 surveys were received. Overall, the interdisciplinary team members agreed or strongly agreed the guideline was clinically applicable. Finally, the guideline was evaluated by a group of doctoral prepared practicing nurse practitioners using the AGREE II instrument. The scores were \u3e80% in every domain, with an overall score of 91%, indicating the guideline is high in quality. Development of this guideline signifies an initial step in the management and prevention of constipation in the LTC resident

Using meta-research methods to examine the inclusion of women, pregnant women, and women-specific health outcomes in studies that contributed to the dietary reference intakes for one-carbon metabolism micronutrients

Purpose: Maternal micronutrient deficiencies occurring during periconceptional, pregnancy, and postpartum periods are a leading cause of adverse pregnancy outcomes globally. The Dietary Reference Intakes (DRIs) are a set of reference values used to assess and guide nutrient intakes of healthy individuals. However, the current DRIs for pregnancy and lactation may be limited in their methods and included populations. The present study analyzed the current DRIs for their inclusion of pregnant women and geographic representativeness. Methods: Meta-research methods were applied to the DRI report for vitamins B6, B12, folate, and choline in four steps: search, screening, full-text data extraction, and data analysis. For each target micronutrient, sections that contributed data to setting the average requirement were focused on, “Selection of Indicators for Estimating the Requirement,” “Findings by Life Stage and Gender Group,” and “Tolerable Upper Intake Limit” for adults, pregnancy, and lactation sub-sections. Screening involved reviewing the reference list to determine whether a reference directly contributed to setting the DRI. Full-text data extraction of primary data was conducted in areas of: 1) administrative information; 2) study methods; 3) human population characteristics; and 4) non-human subjects. Descriptive analyses were performed to describe the inclusion of women, pregnant women, geographic patterns, and demographic diversity. Results: For Vitamin B12, 100% of indicator studies and 71% of life stages studies included women, with a total of 3,246 women participants. However, none of the indicator studies and 15% of life stages studies included pregnant women, with a total of 556 pregnant women participants. None of the indicator studies and 8% of life stages studies reported health measurements specific to women, pregnancy, or lactation. Geographically, 54% of studies were conducted in the United States, and 18% took place in low-and middle-income countries. Data analysis is ongoing for the remaining micronutrients. Conclusions: Preliminary findings indicate that the body of evidence informing the current DRIs are limited in their inclusion of women and pregnant women. Numerous adverse pregnancy and birth outcomes are preventable through optimal maternal nutrition. Therefore, it is critical to ensure that the DRIs are suitable for their intended population. Despite their original intent for use in North America, the DRIs are widely adopted globally. Thus, geographic representation of the studies underlying the DRIs have implications for generalizability

Links between Anr and Quorum Sensing in Pseudomonas aeruginosa Biofilms

In Pseudomonas aeruginosa, the transcription factor Anr controls the cellular response to low oxygen or anoxia. Anr activity is high in oxygen-limited environments, including biofilms and populations associated with chronic infections, and Anr is necessary for persistence in a model of pulmonary infection. In this study, we characterized the Anr regulon in biofilm-grown cells at 1% oxygen in the laboratory strain PAO1 and in a quorum sensing (QS)-deficient clinical isolate, J215. As expected, transcripts related to denitrification, arginine fermentation, high-affinity cytochrome oxidases, and CupA fimbriae were lower in the Δanr derivatives. In addition, we observed that transcripts associated with quorum sensing regulation, iron acquisition and storage, type VI secretion, and the catabolism of aromatic compounds were also differentially expressed in the Δanr strains. Prior reports have shown that quorum sensing-defective mutants have higher levels of denitrification, and we found that multiple Anr-regulated processes, including denitrification, were strongly inversely proportional to quorum sensing in both transcriptional and protein-based assays. We also found that in LasR-defective strains but not their LasR-intact counterparts, Anr regulated the production of the 4-hydroxy-2-alkylquinolines, which play roles in quorum sensing and interspecies interactions. These data show that Anr was required for the expression of important metabolic pathways in low-oxygen biofilms, and they reveal an expanded and compensatory role for Anr in the regulation of virulence-related genes in quorum sensing mutants, such as those commonly isolated from infections

Effects of Multiple Bouts of Long-duration Hindlimb Unloading and Recovery on Rat Plantaris Muscle

Exposure to microgravity results in a rapid reduction of muscle mass. However, few studies exist designed to examine the effects of multiple long-term exposures to microgravity with alternating recovery periods on skeletal muscle. To determine what happens to the recovery of skeletal muscle when faced with subsequent unloading and recovery periods. Male Sprague-Dawley (6 mo) were assigned to the following groups as shown in figure 1 below: 28d hindlimb unloading (1HU), 28d HU session followed by a 56d recovery bout of normal cage ambulation at 1g (1HU+REC), 2 cycles of 28d HU with a 56d recovery period between unloadings (2HU), 2 cycles of 28d HU as in the 2HU group, but followed by an additional 56d recovery at 1g (2HU+REC), and an age- and housing-matched control group (CON). On the final day of the experimental period, plantaris muscles were excised and weighed. The 1HU+REC (0.548 ± 0.012), 2HU+REC (0.562 ± 0.015), and CON (0.550 ± 0.013) showed no statistical difference (p\u3e0.05) between each other. The 1 HU (0.442 ± 0.020) and 2 HU (0.431 ± 0.011) groups were significantly less (p\u3c0.001) than recovery and aged control animals but were not significantly different from each other. The results show that the plantaris muscle presented reduction of muscle mass with initial and subsequent exposures to microgravity. However, with the recovery period, animals were able to regain lost muscle mass, similar to age-matched controls. These findings would be relevant for astronauts participating in multiple long-duration missions throughout their career

A Self-Lysis Pathway that Enhances the Virulence of a Pathogenic Bacterium

In mammalian cells, programmed cell death (PCD) plays important roles in development, in the removal of damaged cells, and in fighting bacterial infections. Although widespread among multicellular organisms, there are relatively few documented instances of PCD in bacteria. Here we describe a potential PCD pathway in Pseudomonas aeruginosa that enhances the ability of the bacterium to cause disease in a lung infection model. Activation of the system can occur in a subset of cells in response to DNA damage through cleavage of an essential transcription regulator we call AlpR. Cleavage of AlpR triggers a cell lysis program through de-repression of the alpA gene, which encodes a positive regulator that activates expression of the alpBCDE lysis cassette. Although this is lethal to the individual cell in which it occurs, we find it benefits the population as a whole during infection of a mammalian host. Thus, host and pathogen each may use PCD as a survival-promoting strategy. We suggest that activation of the Alp cell lysis pathway is a disease-enhancing response to bacterial DNA damage inflicted by the host immune system