Una Acción Civil (1998): la ley detrás del daño corporal, los defectos congénitos y la leucemia / A Civil Action (1998): the law behind bodily harm, birth defects and leukemia

Acción Civil es una película fundamental para comprender cómo la contaminación del ambiente influye en la salud humana, pero también el contexto biopsicosocial, ético, legítimo y legal en torno a la problemática de ejercer el derecho a un ambiente saludable. Muestra cómo la contaminación afecta a las comunidades, la responsabilidad que muchas empresas intentan eludir frente a sus acciones en perjuicio de la vida humana y ambiente y cómo la comunidad y los medios de comunicación pueden trabajar juntos para abordar estas cuestiones y tomar medidas para prevenir y tratar estos problemas. En la docencia universitaria de Ciencias de la Salud, el filme se constituye en un recurso pedagógico para ilustrar y concientizar sobre la problemática de la contaminación del agua potable y ambiente en general en la salud humana y especialmente durante la gestación. El visionado del filme por otro lado estimula el pensamiento crítico, divergente, analítico, reflexivo, emocional y el aprendizaje significativo, al tiempo que permite integrar conocimientos de las asignaturas que cursan y cultura general en una experiencia inmersiva. Asimismo, permite integrar aspectos legales que pocas veces son abordados en la carrera como una transversal educativa que contribuye al acervo de cultura general del estudiante.(AU)

A Civil Action is a fundamental film to understand how environmental contamination influences human health, but also the biopsychosocial, ethical, legitimate and legal context around the problem of exercising the right to a healthy environment. It shows how pollution affects communities, the responsibility that many companies try to evade due to their actions in detriment of human life and the environment, and how the community and the media can work together to address these issues and take measures to prevent and treat these problems. In the university teaching of Health Sciences, the film becomes a pedagogical resource to illustrate and raise awareness about the problem of drinking water contamination and the environment in general in human health and especially during pregnancy. Viewing the film on the other hand stimulates critical, divergent, analytical, reflective, emotional thinking and significant learning, while allowing the integration of knowledge of the subjects they are studying and general culture in an immersive experience. Likewise, it allows the integration of legal aspects that are rarely addressed in the career as an educational transversal that contributes to the heritage of the student's general culture.(AU)

High-Throughput Screening to Advance In Vitro Toxicology: Accomplishments, Challenges, and Future Directions.

Traditionally, chemical toxicity is determined by in vivo animal studies, which are low throughput, expensive, and sometimes fail to predict compound toxicity in humans. Due to the increasing number of chemicals in use and the high rate of drug candidate failure due to toxicity, it is imperative to develop in vitro, high-throughput screening methods to determine toxicity. The Tox21 program, a unique research consortium of federal public health agencies, was established to address and identify toxicity concerns in a high-throughput, concentration-responsive manner using a battery of in vitro assays. In this article, we review the advancements in high-throughput robotic screening methodology and informatics processes to enable the generation of toxicological data, and their impact on the field; further, we discuss the future of assessing environmental toxicity utilizing efficient and scalable methods that better represent the corresponding biological and toxicodynamic processes in humans.

Molecular Toxicology and Cancer Prevention.

Molecular toxicology is a field that investigates the interactions between chemical or biological molecules and organisms at the molecular level [...].

The calculation of historical control limits in toxicology: Do's, don'ts and open issues from a statistical perspective.

For reporting toxicology studies, the presentation of historical control data and the validation of the concurrent control group with respect to historical control limits have become requirements. However, many regulatory guidelines fail to define how such limits should be calculated and what kind of target value(s) they should cover. Hence, this manuscript is aimed to give a brief review on the methods for the calculation of historical control limits that are in use as well as on their theoretical background. Furthermore, this manuscript is aimed to identify open issues for the use of historical control limits that need to be discussed by the community. It seems that, even after 40 years of discussion, more issues remain open than solved, both, with regard to the available methodology as well as its implementation in user-friendly software. Since several of these topics equally apply to several research fields, this manuscript is addressed to all relevant stakeholders who deal with historical control data obtained from toxicological studies, regardless of their background or field of research.

Alternatives to Monkey Reproductive Toxicology Testing for Biotherapeutics.

Embryofetal toxicity studies are conducted to support inclusion of women of childbearing potential in clinical trials and to support labeling for the marketed pharmaceutical product. For biopharmaceuticals, which frequently lack activity in the rodent or rabbit, the nonhuman primate is the standard model to evaluate embryofetal toxicity. These studies have become increasingly challenging to conduct due to the small number of facilities capable of performing them and a shortage of sexually mature monkeys. The low number of animals per group and the high rate of spontaneous abortion in cynomolgus monkeys further complicate interpretation of the data. Recent FDA guidance has proposed a weight of evidence (WoE) approach to support product labeling for reproductive toxicity of products intended to be used for the treatment of cancer (Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations), an approach that has also supported the approval of biotherapeutics for non-cancer indications. Considerations to determine the appropriateness and content of a WoE approach to support product labeling for embryofetal risk include known class effects in humans; findings from genetically modified animals with or without drug administration; information from surrogate compounds; literature-based assessments about the developmental role of the pharmaceutical target; and the anticipated exposure during embryofetal development. This paper summarizes the content of a session presented at the 42nd annual meeting at the American College of Toxicology, which explored the conditions under which alternative approaches may be appropriate to support product labeling for reproductive risk, and how sponsors can best justify the use of this approach.

Environmental exposure to pesticides and Amyotrophic Lateral Sclerosis in the South of Spain / Exposición ambiental a pesticidas y esclerosis lateral amiotrófica en el sur de España

Objective: To determine if there is a relationship between environmental exposure to pesticides and the prevalence of Amyotrophic Lateral Sclerosis (ALS) in Andalusia. Method: We carried out a case–control study using the logistic regression method to verify the relationship between the prevalence of ALS in the area exposed to pesticides versus the unexposed area, through the Odds Ratio statistical test. Results: The study population consisted of 519 individuals diagnosed with ALS between January 2016 and December 2018 according to the CMBD (Minimum Basic Data Set) as cases. In the control group, we have 8,384,083 individuals obtained from data from the National Institute of Statistics (INE). The Odds Ratio (OR) was used as a measure of association between cases and controls, obtaining an OR between 0.76 and 1.08 for the confidence interval of the CI (95%). Conclusions: Despite the existence of various studies that suggest a possible association between environmental exposure to pesticides and the risk of Amyotrophic Lateral Sclerosis, our analysis of the Andalusian population did not find significant evidence of this association.(AU)

Objetivo: Analizar si existe una relación entre la exposición ambiental a pesticidas y la prevalencia de esclerosis lateral amiotrófica (ELA) en Andalucía. Métodos: Realizamos un estudio de casos y controles con regresión logística para esclarecer la relación entre la prevalencia de ELA en el área expuesta a pesticidas vs. el área sin exposición, mediante el cálculo de razón de probabilidades (odds ratio [OR]). Resultados: Incluimos un grupo de casos, con 519 individuos diagnosticados de ELA entre enero de 2016 y diciembre de 2018, obtenidos del conjunto mínimo básico de datos, y un grupo control con 8.384.083 individuos obtenidos de la base de datos del Instituto Nacional de Estadística. Se utilizó la OR para medir la asociación entre casos y controles, con un intervalo de confianza del 95% de 0,76-1,08. Conclusiones: A pesar de que varios estudios sugieren una posible asociación entre la exposición ambiental a pesticidas y un aumento en el riesgo de ELA, nuestro estudio sobre la población andaluza no halló datos significativos en favor de dicha hipótesis.(AU)

The Toxicology Investigators Consortium 2022 Annual Report.

Since 2010, medical toxicology physicians from the American College of Medical Toxicology (ACMT) Toxicology Investigators Consortium (ToxIC) have provided reports on their in-hospital and clinic patient consultations to a national case registry, known as the ToxIC Core Registry. De-identified patient data entered into the registry includes patient demographics, reason for medical toxicology evaluation, exposure agents, clinical signs and symptoms, treatments and antidotes administered, and mortality. This thirteenth annual report provides data from 7206 patients entered into the Core Registry in 2022 by 35 participating sites comprising 52 distinct healthcare facilities, bringing the total case count to 94,939. Opioid analgesics were the most commonly reported exposure agent class (15.9%), followed by ethanol (14.9%), non-opioid analgesic (12.8%), and antidepressants (8.0%). Opioids were the leading agent of exposure for the first time in 2022 since the Core Registry started. There were 118 fatalities (case fatality rate of 1.6%). Additional descriptive analyses in this annual report were conducted to describe the location of the patient during hospitalization, telemedicine consultations, and addiction medicine treatments.

Current state-of-the-art approaches for mass spectrometry in clinical toxicology: an overview.

INTRODUCTION: Hyphenated mass spectrometry (MS) has evolved into a very powerful analytical technique of high sensitivity and specificity. It is used to analyze a very wide spectrum of analytes in classical and alternative matrices. The presented paper will provide an overview of the current state-of-the-art of hyphenated MS applications in clinical toxicology primarily based on review articles indexed in PubMed (1990 to April 2023). AREAS COVERED: A general overview of matrices, sample preparation, analytical systems, detection modes, and validation and quality control is given. Moreover, selected applications are discussed. EXPERT OPINION: A more widespread use of hyphenated MS techniques, especially in systematic toxicological analysis and drugs of abuse testing, would help overcome limitations of immunoassay-based screening strategies. This is currently hampered by high instrument cost, qualification requirements for personnel, and less favorable turnaround times, which could be overcome by more user-friendly, ideally fully automated MS instruments. This would help making hyphenated MS-based analysis available in more laboratories and expanding analysis to a large number of organic drugs, poisons, and/or metabolites. Even the most recent novel psychoactive substances (NPS) could be presumptively identified by high-resolution MS methods, their likely presence be communicated to treating physicians, and be confirmed later on.

[Deductive Toxicology and Bioorganometallics].

Toxicology based on a deductive approach is called "deductive toxicology," which attempts to explain clinical and pathological findings by collecting all scientific information about the chemical substance under study and relating them to the essence of toxicity. We have introduced the method of signal toxicology into the deductive toxicology of metal and have shown that signal toxicity exists in heavy metals. Based on the results, we have proposed a new research strategy called "bioorganometallics," in which organic-inorganic hybrid molecules are used as molecular probes to analyze biological systems. This review outlines our research that has evolved from "deductive toxicology" to "bioorganometallics."

State of the Art of Genomic Technology in Toxicology: A Review.

The rapid growth of genomics techniques has revolutionized and impacted, greatly and positively, the knowledge of toxicology, ushering it into a "new era": the era of genomic technology (GT). This great advance permits us to analyze the whole genome, to know the gene response to toxicants and environmental stressors, and to determine the specific profiles of gene expression, among many other approaches. The aim of this work was to compile and narrate the recent research on GT during the last 2 years (2020-2022). A literature search was managed using the PubMed and Medscape interfaces on the Medline database. Relevant articles published in peer-reviewed journals were retrieved and their main results and conclusions are mentioned briefly. It is quite important to form a multidisciplinary taskforce on GT with the aim of designing and implementing a comprehensive, collaborative, and a strategic work plan, prioritizing and assessing the most relevant diseases, so as to decrease human morbimortality due to exposure to environmental chemicals and stressors.