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Women's Health Research, barely 40-year-old in the United States has recently received an all-important boost from First Lady Jill Biden. The $100 million in question are bound to make a meaningful difference in this all-important arena. It was the view of the White House that "our nation must fundamentally change how we approach and fund women's health research." The White House expressed its hope that "congressional leaders, the private sector, research institutions, and philanthropy" will answer the call to "improve the health and lives of women throughout the nation." [ABSTRACT FROM AUTHOR]

The article presents a case study of a patient with abdominal ileus masquerading as acute coronary syndrome, underscoring the importance of considering extra-cardiac pathophysiology in evaluating cardiac complaints, particularly in the context of abdominal distention, which can exert pressure on neighboring organs within the thoracic cavity, potentially leading to myocardial ischemia and electrocardiographic changes consistent with myocardial infarction.

The article focuses on the importance and uncertainties surrounding the World Health Organization (WHO) Pandemic Treaty aimed at strengthening global health systems against future pandemics. Topics include the treaty's emphasis on equity and international collaboration; the concerns about national sovereignty raised by some countries; and the mixed political reception in the U.S. regarding its potential ratification.

Serialization technology was introduced to protect the pharmaceutical supply chain from falsified and substandard medicines infiltration. The implementation of serialization systems required a substantial investment by pharmaceutical manufacturers. This study investigated the impact of Serialisation on operational efficiency and productivity in the pharmaceutical industry. A literature review demonstrated limited publications on Serialisation concerning its costs and effects on packing line operational efficiency and productivity. Therefore, a literature review was carried out to assess the relationship between Serialisation, operational efficiency, and productivity. The study revealed that Serialisation had the potential to impact pack line Operational Equipment Effectiveness negatively and line availability, as well as the unit cost of packaged pharmaceuticals and that actual capital costs of Serialisation were greater than the costs originally outlined by policymakers. In addition, the study identified a trend where pharmaceutical sites move away from smaller batch production and toward larger batches to gain greater efficiencies. This is the first study of Serialisation literature from a manufacturing viewpoint. [ABSTRACT FROM AUTHOR]

The 1984 National Organ Transplant Act (NOTA) saw to the establishment of a national Organ Procurement and Transplantation Network (OPTN). As envisaged by the law’s congressional sponsors, the Secretary of the US Department of Health and Human Services (HHS) was to institute a “central registry linking donors and potential recipients.” In addition, the Secretary was to see to the institution of a “scientific registry of organ recipients” as well as “designate and maintain an identifiable unit in the Public Health Service to coordinate Federal organ transplant programs and policies.” Forty years later, over 103,000 patients remain on the organ transplant waiting list for an average of 3–5 years during which time 17 die every day. It is against this backdrop that the Senate Committee on Finance (SCF) launched a sustained inquiry in 2020 with an eye towards assessing the status quo and potential remedies thereof. A Health Resources & Services Administration (HRSA) Modernization Initiative followed suit in March 2023. In this Perspective, we review the state of OPTN, discuss its recent oversight by the SCF, and describe its future reform as conceived and enunciated by HRSA. [ABSTRACT FROM AUTHOR]

The article discusses the history and reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) in the United States. PAHPA was first passed in 2006 as a response to various emergencies, including the 9/11 terrorist attack and the 2005 Hurricane season. It aims to prepare the country for chemical, biological, radiological, nuclear, and pandemic threats. The article highlights the calls for stakeholder input in the reauthorization process and discusses recommendations made by various organizations, such as the National Association of Governors and the Johns Hopkins Center for Health Security. The reauthorization of PAHPA is currently in the hands of the 118th US Congress, and given the ongoing COVID-19 pandemic, it is unlikely to fail. [Extracted from the article]

This Viewpoint discusses the maternal mortality crisis in the US, the need for an extension of Medicaid postpartum coverage, and the residual challenges across the US related to maternal health. [ABSTRACT FROM AUTHOR]

The authors comment on the Guidance for Industry released by the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) to clarify its Final Rule on the 'Importation of Prescription Drugs' and the importation of certain prescription drugs from Canada. Topics discussed include states with drug importation laws, challenges to importation of drugs, and criticism on an importation program from Canada.

This Viewpoint examines the coverage gap in health insurance in the US and its potential redress by enhancing federal outreach to the uninsured, rendering permanent the health insurance benefits of the American Rescue Plan Act, and establishing a federal health insurance program for low-income adults in states that did not expand their Medicaid programs. [ABSTRACT FROM AUTHOR]

This article presents the author's opinions on the U.S. Government Printing Office report titled "Regional Depository Libraries in the 21st Century: A Time for Change?" According to the author, the report does not adequately address the role of depository libraries in assuring permanent public access to government publications. The author also discusses the need to change Title 44 of the U.S. Code.

Congressional and presidential records reveal a consistent pattern of political intercession with the regulatory authority of the Food and Drug Administration (FDA) over the approval and labeling of mifepristone (RU-486). This pattern is unlikely to abate any time soon. It is against this backdrop that we examine herein the ongoing legislative and legal disputes over mifepristone at a point in time which is just beyond the 20th anniversary of its approval by the FDA "for the medical termination of intrauterine pregnancy." [ABSTRACT FROM AUTHOR]

Lectin mimetics have been identified that may have potential application towards targeted drug delivery. Synthetic multivalent polygalloyl constructs effectively competed with Ulex europaeus agglutinin I (UEA1) for binding to intestinal Caco-2 cell membranes. [Copyright &y& Elsevier]

The incorporation of pegylated lipid into Lipid-Protamine-DNA (LPD-PEG) lipopolyplexes causes a decrease of their in vitro transfection activity. This can be partially attributed to a reduction in particle binding to cells. To restore particle binding and specifically target LPD formulations to tumor cells, the lipid-peptide conjugate DSPE-PEG5K-succinyl-ACDCRGDCFCG-COOH (DSPE-PEG5K-RGD-4C) was generated and incorporated into LPD formulations (LPD-PEG-RGD). LPD-PEG-RGD was characterized with respect to its biophysical and biological properties. The Incorporation of DSPE-PEG5K-RGD-4C ligands into LPD formulations results in a 5 and a 15 fold increase in the LPD-PEG-RGD binding and uptake, respectively, over an LPD-PEG formulation. Enhancement of binding and uptake resulted in a 100 fold enhancement of transfection activity. Moreover, this transfection enhancement was specific to cells expressing appropriate integrin receptors (MDA-MB-231). Huh7 cells, known for their low level of αvβ3 and αvβ5 integrin expression, failed to show RGD mediated transfection enhancement. This transfection enhancement can be abolished in a competitive manner using free RGD peptide, but not an RGE control peptide. Results demonstrated RGD mediated enhanced LPD-PEG cell binding and transfection in cells expressing the integrin receptor. These formulations provide the basis for effective, targeted, systemic gene delivery. [ABSTRACT FROM AUTHOR]

Mammalian Peyer’s Patches possess specialized epithelium, the follicle associated epithelium (FAE), and specialized cells called M cells which mediate transcytosis of antigens to underlying lymphoid tissue. To identify FAE specific genes, we used TOGA gene expression profiling of microdissected mouse Peyer’s Patch tissue. We found expression of laminin β3 across the FAE, and scattered expression of peptidoglycan recognition protein (PGRP)-S. Using the M cell specific lectin Ulex europaeus agglutinin 1 (UEA-1), PGRP-S expression was nearly exclusively co-localized with UEA-1+ M cells. By contrast, the related gene PGRP-L was expressed among a subset of UEA-1 negative FAE cells. Expression of these proteins in transfected cells demonstrated distinct subcellular localization. PGRP-S showed a vesicular pattern and extracellular secretion, while PGRP-L showed localization to both the cytoplasm and the cell surface. The potential function of these PGRP proteins as pattern recognition receptors and their distinctive cellular distribution suggests a complex coordination among specialized cells of the FAE in triggering mucosal immunity and innate immune responses. [Copyright &y& Elsevier]

Drug delivery technologies are commonly directed towards formulations to control the delivery of therapeutic compounds. However, many processes in the human body have evolved to regulate the transport of various molecules, cells, or particles across epithelial barriers. To take advantage of this biology, we used TOGA® gene expression profiling to identify receptor or transporter molecules to target delivery vehicles for transport across an epithelial barrier. In the case of intestinal epithelium, we sought molecules associated with the transport of particles by Peyer’s patch M cells. We have identified genes specific to Peyer’s patch epithelium, some of which appear to be M cell specific. Discoveries made by this process will provide targets for development of new vaccines, but also provide new insights into the biology of transepithelial transport. The power of this gene profiling approach also suggests application to other systems, such as the response to metabolic changes or drug treatments. [Copyright &y& Elsevier]