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A call for the United States to continue investing in science.

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… Indeed, historically there has been widespread bipartisan support for biomedical funding by the federal government. Below we discuss the U.S. scientific research enterprise and provide evidence and arguments we hope the ASM community can use to advocate for science. …

A call for the United States to continue investing in science.

Аннотация не предоставлена источником. Откройте карточку для перехода к публикации.

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… Indeed, historically there has been widespread bipartisan support for biomedical funding by the federal government. Below we discuss the U.S. scientific research enterprise and provide evidence and arguments we hope the ASM community can use to advocate for science. …

Global ethylene oxide uses in foods and considerations for food safety.

Ethylene oxide (EtO) is a sterilant widely used for medical devices, but its use is controversial due to its carcinogenicity. In some countries, EtO is also used to fumigate food to eliminate foodborne pathogens, though this practice is banned in others. National regulations on EtO use in food vary widely; exporting countries prioritize trade facilitation and prevention of foodborne illness, while importing countries emphasize maintaining food safety and promoting domestic public health. These divergent public health priorities present challenges to establishing universal maximum residue limit

Timeliness of Health Technology Assessments and Price Negotiations for Oncology Drugs in Canada.

PurposeTo evaluate whether time targets for Canadian Agency for Drugs and Technologies in Health (CADTH) reimbursement reviews and pan-Canadian Pharmaceutical Alliance (pCPA) price negotiations are being achieved for oncology drugs.Materials and methodsRecommendations, dates of submission and publication, and indications for oncology medicines issued between January 2014 and December 2023 were recorded from CADTH's reimbursement reports webpage. The date any negotiation began and the date it was completed (successfully or not), or when a decision was made not to pursue negotiation was extracte

Judicialization of health: profile of demands for oncological medicines in a state in the central region of Brazil.

BACKGROUND: The significant increase in access to oncological medicines through court cases suggests that constitutional guarantees of integral and universal care in the Brazilian public health system are uncertain. METHODS: A retrospective observational study was conducted to analyze data from lawsuits requesting oncological medicines from 2014 to 2020 in the State of Goiás, Brazil, in state and federal courts. Sociodemographic, medical, and legal variables were statistically examined using descriptive, association, and correlation methods. RESULTS: Women brought more than half (54%) of the

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… Furthermore, to integrate resources to prevent and fight cancer, the federal government created the national cancer care support program (PRONON) in 2012 [ 15 ]. … Regarding the judicial entity, the state of Goiás (88%) was preferred over the federal government (12%) in the present study. …

Second-Class Care: How Immigration Law Transforms Clinical Practice in the Safety Net.

This article examines how U.S. immigration law extends into the health care safety net, enacting medical legal violence that diminishes noncitizens' health chances and transforms clinical practices. Drawing on interviews with health care workers in three U.S. states from 2015 to 2020, I ask how federal citizenship-based exclusions within an already stratified health care system shape the clinical trajectories of noncitizens in safety-net institutions. Focusing specifically on cancer care, I find that increasingly anti-immigrant federal policies often reshape clinical practices toward noncitize

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… Although some jurisdictions partially mitigate these federal exclusions through sanctuary policies and universal health coverage schemes (e.g., Houston et al. 2022 ; Marrow and Joseph 2015 ), the federal government retains substantial power to determine who gets high-level safety-net care. …

The organization, weaknesses, and challenges of the control of thalidomide in Brazil: A review.

The drug thalidomide has resurged in the world market under restrictive conditions for marketing and use. In Brazil, there are still cases of pregnant women using thalidomide even after the implementation of laws that regulate the control of use (Law No. 10.651/2003 and Collegiate Board Resolution No. 11/2011). The objective of this study was to discuss the control of thalidomide use in Brazil, based on a scoping review of the scientific literature, documents, and data from the Ministry of Health. A total of 51 studies and documents related to the following subthemes were selected: (1) organiz

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… . | [ 3 , 31 ] In compliance with Brazilian laws (Law No. 7.070 of 12/20/1982 and Law No. 12.190 of 01/13/2010), the federal government should grant a lifetime special pension and indemnity to people with physical disabilities that occurred as a consequence of thalidomide use [ 56 , 57 ]. … These individuals were compensated by the federal government and were spread over all regions of the country: 27 in the North, 143 in the Northeast, 150 in the Central-West, 533 in the Southeast, and 220 in the South [ 4 ]. …

Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets.

Cell and gene therapies (CGTs) have progressed from proof of concept to an established commercial pipeline, yet global translation remains constrained by fragmented regulatory frameworks; heterogeneous Chemistry, Manufacturing, and Controls (CMC) requirements; and divergent approval pathways. This narrative review compares CGT quality, CMC, and approval-pathway regulation across the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), together with five emerging-market agencies: Brazil, Russia, India, China, and

Financial challenges of being on long-term, high-cost medications.

The isocitrate dehydrogenase (IDH) inhibitor, vorasidenib, may offer a promising new treatment option for patients with IDH-mutant gliomas. However, the indefinite nature of this targeted therapy raises significant financial concerns. High costs of targeted cancer therapies, often exceeding $150 000 annually, contribute to financial toxicity, characterized by medical debt, income loss, and psychological stress, and place stress on health systems. This review analyzes the drug approval and pricing mechanisms in various countries and their impact on healthcare costs and patient access, focusing

What is the cost-effectiveness of menu calorie labelling on reducing obesity-associated cancer burdens? An economic evaluation of a federal policy intervention among 235 million adults in the USA.

ObjectiveTo assess the impact of menu calorie labelling on reducing obesity-associated cancer burdens in the USA.DesignCost-effectiveness analysis using a Markov cohort state-transition model.SettingPolicy intervention.ParticipantsA modelled population of 235 million adults aged ≥20 years in 2015-2016.InterventionsThe impact of menu calorie labelling on reducing 13 obesity-associated cancers among US adults over a lifetime was evaluated for: (1) effects on consumer behaviours; and (2) additional effects on industry reformulation. The model integrated nationally representative demographics, cal

От прогнозирования к вмешательству: Искусственный интеллект для адаптивного реагирования и моделирования токсичности в клеточной терапии для гематологовых злодеяний.

Гематологическая магнелезность, включая острую лейкемию миэлоида, миэлодипластические синдромы, лимфому и множественную миелому, характеризуется глубокой биологической гетерогенностью и высокодинамичными траекториями лечения, которые традиционные статические прогнозирующие системы неполно улавливают. Клеточная терапия, такая, как химерик антигенная рецепторная терапия Т-клеток и трансплантация стволовых клеток с гематополией, предлагает потенциально лечебные варианты для рецидива или рефракторного заболевания, однако результаты остаются весьма различными, а управленческие решения, касающиеся и

Ten years of AMNOG from an oncological perspective: new horizons and continuing expansion.

Purpose2021 marks the tenth anniversary of the AMNOG process and brought with it a new German administration-two good reasons to take stock of where we stand today, what has been achieved so far, and how the path of early benefit assessments in Germany should continue.ResultsFrom the perspective of manufacturers of cancer drugs, the AMNOG process, as a constantly evolving system, has for the most part proved itself-which does not mean that there is no longer room for improvement. Significant improvements have been achieved in the area of early consultation of medical societies regarding the se

Overcoming obstacles to repurposing for neurodegenerative disease.

Repurposing Food and Drug Administration (FDA)-approved drugs for a new indication may offer an accelerated pathway for new treatments to patients but is also fraught with significant commercial, regulatory, and reimbursement challenges. The Alzheimer's Drug Discovery Foundation (ADDF) and the Michael J. Fox Foundation for Parkinson's Research (MJFF) convened an advisory panel in October 2013 to understand stakeholder perspectives related to repurposing FDA-approved drugs for neurodegenerative diseases. Here, we present opportunities on how philanthropy, industry, and government can begin to a

Global, regional, and national disability-adjusted life-years (DALYs) for 315 diseases and injuries and healthy life expectancy (HALE), 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015.

BACKGROUND: Healthy life expectancy (HALE) and disability-adjusted life-years (DALYs) provide summary measures of health across geographies and time that can inform assessments of epidemiological patterns and health system performance, help to prioritise investments in research and development, and monitor progress toward the Sustainable Development Goals (SDGs). We aimed to provide updated HALE and DALYs for geographies worldwide and evaluate how disease burden changes with development. METHODS: We used results from the Global Burden of Diseases, Injuries, and Risk Factors Study 2015 (GBD 20

Federated Computing in Orthopaedic Surgery: A Paradigm Shift in Collaborative Multicenter Research.

➢ Multicenter studies remain rare in orthopaedics (9.9% of recent publications) due to regulatory complexity, restrictive data-sharing policies, and administrative delays, despite their proven value in generating robust, generalizable evidence. ➢ Federated computing (FC) brings analytic code to each institution's data and returns only encrypted, aggregated results. This preserves patient privacy, maintains institutional control, and streamlines compliance by reducing or eliminating the need for complex data-use agreements. ➢ Extensive applications in other medical fields show that FC can match

Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I-conceptual challenges.

The sharing of clinical trial data and biomarker data sets among the scientific community, whether the data originates from pharmaceutical companies or academic institutions, is of critical importance to enable the development of new and improved cancer immunotherapy modalities. Through data sharing, a better understanding of current therapies in terms of their efficacy, safety and biomarker data profiles can be achieved. However, the sharing of these data sets involves a number of stakeholder groups including patients, researchers, private industry, scientific journals and professional societ

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… An example that could serve as a model registry program for society-led efforts is the FNIH PACT, which is engaged in efforts on behalf of several academic institutions, biotech and pharmaceutical companies, and the federal government and is involved in standardizing immunotherapy assays with the Cancer …

Burden and temporal trends of non-communicable diseases from 1990 to 2021 and prediction to 2035 in the group of twenty countries: a systematic analysis of the Global Burden of Disease Study 2021.

BackgroundNon-communicable diseases (NCDs) represent a major global public health threat, closely linked to disruptions in host-microbe symbiosis and metabolic homeostasis. The Group of Twenty (G20) comprises the world's major economic powers with diverse developmental stages, yet the NCD burden and its potential implications for host and ecosystem resilience remain poorly characterized across these nations. This study aimed to systematically estimate the burden, temporal trends, and future projections of NCDs from 1990 to 2021 and up to 2035 in G20 countries.MethodsUsing data from the Global

Препятствия и факторы, способствующие реформированию системы здравоохранения.

ВВЕДЕНИЕ: Системы здравоохранения во всем мире сталкиваются с растущим давлением, обусловленным растущим бременем неинфекционных заболеваний и старением населения, а также хронической нехваткой рабочей силы, инфраструктурными ограничениями и структурными дисгармониями между моделями ухода, предназначенными для лечения острых заболеваний, и долгосрочными потребностями сложных пациентов. Многие страны предпринимают комплексные усилия по преобразованию, включая перенос ухода ближе к дому, улучшение раннего выявления заболеваний и решение проблем, связанных с рабочей силой. Цель этого исследования

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… . | Yes | Yes | | ( 41 ) Canada's primary care crisis: Federal government response | Canada | Not specified | D | No condition focus | Explores options for the federal government to take a more hands-on role responding to the present crisis that are constitutionally compliant. | | Yes | Yes | ( 80 …

Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015.

BACKGROUND: Non-fatal outcomes of disease and injury increasingly detract from the ability of the world's population to live in full health, a trend largely attributable to an epidemiological transition in many countries from causes affecting children, to non-communicable diseases (NCDs) more common in adults. For the Global Burden of Diseases, Injuries, and Risk Factors Study 2015 (GBD 2015), we estimated the incidence, prevalence, and years lived with disability for diseases and injuries at the global, regional, and national scale over the period of 1990 to 2015. METHODS: We estimated incid

Digital therapeutics from bench to bedside.

As a new therapeutic technique based on digital technology, the commercialization and clinical application of digital therapeutics (DTx) are increasing, and the demand for expansion to new clinical fields is remarkably high. However, the use of DTx as a general medical component is still ambiguous, and this ambiguity may be owing to a lack of consensus on a definition, in addition to insufficiencies in research and development, clinical trials, standardization of regulatory frameworks, and technological maturity. In this study, we conduct an in-depth investigation and analysis of definitions,