Curbing the major and growing threats from invasive alien species is urgent and achievable.

Although invasive alien species have long been recognized as a major threat to nature and people, until now there has been no comprehensive global review of the status, trends, drivers, impacts, management and governance challenges of biological invasions. The Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services (IPBES) Thematic Assessment Report on Invasive Alien Species and Their Control (hereafter 'IPBES invasive alien species assessment') drew on more than 13,000 scientific publications and reports in 15 languages as well as Indigenous and local knowledge on all taxa, ecosystems and regions across the globe. Therefore, it provides unequivocal evidence of the major and growing threat of invasive alien species alongside ambitious but realistic approaches to manage biological invasions. The extent of the threat and impacts has been recognized by the 143 member states of IPBES who approved the summary for policymakers of this assessment. Here, the authors of the IPBES assessment outline the main findings of the IPBES invasive alien species assessment and highlight the urgency to act now.

Taming the terminological tempest in invasion science.

Standardised terminology in science is important for clarity of interpretation and communication. In invasion science - a dynamic and rapidly evolving discipline - the proliferation of technical terminology has lacked a standardised framework for its development. The result is a convoluted and inconsistent usage of terminology, with various discrepancies in descriptions of damage and interventions. A standardised framework is therefore needed for a clear, universally applicable, and consistent terminology to promote more effective communication across researchers, stakeholders, and policymakers. Inconsistencies in terminology stem from the exponential increase in scientific publications on the patterns and processes of biological invasions authored by experts from various disciplines and countries since the 1990s, as well as publications by legislators and policymakers focusing on practical applications, regulations, and management of resources. Aligning and standardising terminology across stakeholders remains a challenge in invasion science. Here, we review and evaluate the multiple terms used in invasion science (e.g. 'non-native', 'alien', 'invasive' or 'invader', 'exotic', 'non-indigenous', 'naturalised', 'pest') to propose a more simplified and standardised terminology. The streamlined framework we propose and translate into 28 other languages is based on the terms (i) 'non-native', denoting species transported beyond their natural biogeographic range, (ii) 'established non-native', i.e. those non-native species that have established self-sustaining populations in their new location(s) in the wild, and (iii) 'invasive non-native' - populations of established non-native species that have recently spread or are spreading rapidly in their invaded range actively or passively with or without human mediation. We also highlight the importance of conceptualising 'spread' for classifying invasiveness and 'impact' for management. Finally, we propose a protocol for classifying populations based on (i) dispersal mechanism, (ii) species origin, (iii) population status, and (iv) impact. Collectively and without introducing new terminology, the framework that we present aims to facilitate effective communication and collaboration in invasion science and management of non-native species.

Low nephron endowment increases susceptibility to renal stress and chronic kidney disease.

Preterm birth results in low nephron endowment and increased risk of acute kidney injury (AKI) and chronic kidney disease (CKD). To understand the pathogenesis of AKI and CKD in preterm humans, we generated potentially novel mouse models with a 30%-70% reduction in nephron number by inhibiting or deleting Ret tyrosine kinase in the developing ureteric bud. These mice developed glomerular and tubular hypertrophy, followed by the transition to CKD, recapitulating the renal pathological changes seen in humans born preterm. We injected neonatal mice with gentamicin, a ubiquitous nephrotoxic exposure in preterm infants, and detected more severe proximal tubular injury in mice with low nephron number compared with controls with normal nephron number. Mice with low nephron number had reduced proliferative repair with more rapid development of CKD. Furthermore, mice had more profound inflammation with highly elevated levels of MCP-1 and CXCL10, produced in part by damaged proximal tubules. Our study directly links low nephron endowment with postnatal renal hypertrophy, which in this model is maladaptive and results in CKD. Underdeveloped kidneys are more susceptible to gentamicin-induced AKI, suggesting that AKI in the setting of low nephron number is more severe and further increases the risk of CKD in this vulnerable population.

The Upper Range Limit of Alien Plants Is Not in Equilibrium with Climate in the Andes of Central Chile.

Alien plant species are colonizing high-elevation areas along roadsides. In this study, we evaluated whether the distributions of alien plants in the central Chilean mountains have reached climatic equilibrium (i.e., upper distribution limits consistent with their climatic requirements). First, we evaluated whether the upper elevational limits of alien plants changed between 2008 and 2018 based on the Mountain Invasion Research Network (MIREN) database. Second, we compared the observed upper elevational limits with the upper limits predicted by each species' global climatic niche. On average across species, the upper elevation limit did not change between 2008 and 2018. However, most species maintained the same limit or shifted downward, while only 23% of the species shifted upwards. This lack of change does not mean that the species' distributions are in equilibrium with the climate, because the observed upper limit was lower than the limit predicted by the global niche model for 87% of species. Our results suggest that alien species in this study region may not only be climate-limited, but could also be limited by other local-scale factors, such as seed dispersal, intermittent disturbance rates, soil type and biotic interactions.

The Genus Kalanchoe (Crassulaceae) in Ecuador: From Gardens to the Wild.

The genus Kalanchoe, mostly indigenous from Madagascar and Tropical Africa, is widely traded for ornamental value. In this study, we provided an updated list of wild and cultivated Kalanchoe taxa in Ecuador; we analyzed the temporal-spatial pattern of their records, and we categorized the invasion status for each taxon and its environment preferences. The records of any taxa belonging to this genus were compiled from an extensive search using various information sources. Our results confirmed the presence of 16 taxa of Kalanchoe in the country. Seven species and a hybrid were detected in the wild. Kalanchoe densiflora, K. laxiflora, K. pinnata, K. tubiflora, and K. ×houghtonii were categorized as invasive. We detected invasive records of some of these plants in protected areas. Almost all taxa had at least one record as cultivated, suggesting that the invasion pathway is ornamental trade. Kalanchoe pinnata individuals in the wild were recorded in the four biogeographic regions of Ecuador, which could be associated with the wide range of precipitations and temperatures in which the species may dwell. Our study highlights the importance of reducing the ornamental value and limiting the use of Kalanchoe taxa with invasive potential in horticulture and promoting, instead, the use of indigenous species.

Meta-analysis of the impact of plant invasions on soil microbial communities.

BACKGROUND: One of the ecological impacts of exotic plant invasions may be alteration of the soil microbial community, which may cause changes to the diversity, richness and function of these communities. In order to explore to what extent invasive plants affect the soil microbial community, we performed a meta-analysis based on 46 scientific articles to document the effect of invasive plants on species richness and diversity of bacteria and fungi. We conducted our study across a range of invaded ecosystems including native communities, and evaluated biomass, richness and diversity. We use a random effects model to determine the increase or decrease in the values of the response variables in the presence of invasive plants. RESULTS: The results indicated that the response variable that changed with the invasion of plants was the diversity of bacteria. Bacterial diversity in the soil increases with the presence of invasive plants, specifically herbaceous plants producing allelopathic substances growing in forest ecosystems of temperate zones. CONCLUSIONS: We provide evidence that invasive plants affect the soil biota differentially; however, it is important to consider more variables such as the N and C cycles, since these processes are mediated by soil biota and litter, and chemical compounds released by plants influence them. Changes in bacterial diversity have consequences for the nutrient cycle, enzymatic activity, mineralization rates and soil carbon and nitrogen content.

Global distribution patterns and niche modelling of the invasive Kalanchoe × houghtonii (Crassulaceae).

Invasive alien species are currently considered one of the main threats to global biodiversity. One of the most rapidly expanding invasive plants in recent times is Kalanchoe × houghtonii (Crassulaceae), an artificial hybrid created in the 1930s in the United States by experimental crossings between K. daigremontiana and K. tubiflora, two species endemic to Madagascar. Thanks to its large colonizing capacity (mainly derived from the production of asexual plantlets), K. × houghtonii soon escaped from cultivation and quickly spread in many parts of the world. However, its actual range is not well known due to the lack of a formal description until recent times (2006) and its strong morphological resemblance with one of its parentals (K. daigremontiana). The present study was aimed, in the first instance, to delimit the present distribution area of K. × houghtonii at the global scale by gathering and validating all its occurrences and to track its colonization history. Currently, K. × houghtonii can be found on all continents except Antarctica, although it did not reach a global distribution until the 2000s. Its potential distribution, estimated with MaxEnt modelling software, is mainly centered in subtropical regions, from 20° to 40° of both northern and southern latitudes, mostly in areas with a high anthropogenic activity. Unexpectedly, concomitant to a poleward migration, future niche models suggest a considerable reduction of its range by up to one-third compared to the present, which might be related with the Crassulaceaean Acid Metabolism (CAM) of K. × houghtonii. Further research may shed light as to whether a decrease in potential habitats constitutes a general pattern for Crassulaceae and CAM plants.

Consensus on management of metastatic colorectal cancer in Central America and the Caribbean: San José, Costa Rica, August 2016.

Colorectal cancer (CRC) is the third most common cancer in men and the second most common in women worldwide. In Latin America and the Caribbean, it has a mortality of 56%. The median overall survival for patients with metastatic colorectal cancer (mCRC) is currently estimated as ~30 months, which has substantially improved through strategic changes in treatment and in the management of patients. As opposed to other metastatic cancers where first-line regimens are often determined, mCRC requires special attention because there is controversy in the possible combinations of the available drugs and the different periods of duration for each patient. Each combination must seek to be effective and to generate the minimum adverse effects as possible. Instead of giving the first-line regimen until the tumour progresses, treatment is often individualised. Furthermore, up to 60% of colorectal tumours are considered non-mutated or wild-type CRC. Not harbouring mutations in the RAS family of genes or mutations in the signalling pathways of the epidermal growth factor receptor causes a null response to anti-epidermal growth factor receptor antibody therapy, which implies even more complex considerations regarding its management. The primary objective of this consensus is to address the main scenarios of mCRC in order to warrant the most appropriate therapeutic intervention for these patients in the Central American and the Caribbean (CAC) region. This can lead to better clinical outcomes as well as quality of life for palliative patients. This document includes the formal expert consensus recommendations for scenarios of mutated and non-mutated mCRC, including synchronous or metachronous disease, management of mCRC with liver and lung metastasis, resectable, potentially resectable or non-resectable tumours and local in the CAC context.

Mating system, population growth, and management scenario for Kalanchoe pinnata in an invaded seasonally dry tropical forest.

Ecological invasions are a major issue worldwide, where successful invasion depends on traits that facilitate dispersion, establishment, and population growth. The nonnative succulent plant Kalanchoe pinnata, reported as invasive in some countries, is widespread in remnants of seasonally dry tropical forest on a volcanic outcrop with high conservation value in east-central Mexico where we assessed its mating system and demographic growth and identified management strategies. To understand its local mating system, we conducted hand-pollination treatments, germination, and survival experiments. Based on the experimental data, we constructed a life-stage population matrix, identified the key traits for population growth, weighted the contributions of vegetative and sexual reproduction, and evaluated management scenarios. Hand-pollination treatments had slight effects on fruit and seed setting, as well as on germination. With natural pollination treatment, the successful germination of seeds from only 2/39 fruit suggests occasional effective natural cross-pollination. The ratios of the metrics for self- and cross-pollinated flowers suggest that K. pinnata is partially self-compatible. Most of the pollinated flowers developed into fruit, but the seed germination and seedling survival rates were low. Thus, vegetative propagation and juvenile survival are the main drivers of population growth. Simulations of a virtual K. pinnata population suggest that an intense and sustained weeding campaign will reduce the population within at least 10 years. Synthesis and applications. The study population is partially self-compatible, but sexual reproduction by K. pinnata is limited at the study site, and population growth is supported by vegetative propagation and juvenile survival. Demographic modeling provides key insights and realistic forecasts on invasion process and therefore is useful to design management strategies.

General Principles for the Education and Training of GCP Inspectors: The Outcome of Discussions by International Regulatory Experts in the Discussion Group on the ICH E6 Guideline.

In response to the globalization of drug development, regulatory inspection of Good Clinical Practice (GCP) has recently been conducted not only by International Conference on Harmonisation (ICH) regions but also non-ICH regions. To promote the international implementation of GCP, consistent understanding and interpretation of its concept among regions are important. This article summarizes the background and past activities of the E6 Discussion Group, established under the Regulators Forum.

Global invasion of Lantana camara: has the climatic niche been conserved across continents?

Lantana camara, a native plant from tropical America, is considered one of the most harmful invasive species worldwide. Several studies have identified potentially invasible areas under scenarios of global change, on the assumption that niche is conserved during the invasion process. Recent studies, however, suggest that many invasive plants do not conserve their niches. Using Principal Components Analyses (PCA), we tested the hypothesis of niche conservatism for L. camara by comparing its native niche in South America with its expressed niche in Africa, Australia and India. Using MaxEnt, the estimated niche for the native region was projected onto each invaded region to generate potential distributions there. Our results demonstrate that while L. camara occupied subsets of its original native niche in Africa and Australia, in India its niche shifted significantly. There, 34% of the occurrences were detected in warmer habitats nonexistent in its native range. The estimated niche for India was also projected onto Africa and Australia to identify other vulnerable areas predicted from the observed niche shift detected in India. As a result, new potentially invasible areas were identified in central Africa and southern Australia. Our findings do not support the hypothesis of niche conservatism for the invasion of L. camara. The mechanisms that allow this species to expand its niche need to be investigated in order to improve our capacity to predict long-term geographic changes in the face of global climatic changes.

Long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray for breakthrough cancer pain in opioid-tolerant patients.

OBJECTIVE: to assess the long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray (FPNS) in patients with breakthrough cancer pain (BTCP). DESIGN: a multicenter, open-label study. PATIENTS: patients with chronic cancer pain treated with > or = 60 mg/d oral morphine or equivalent experiencing 1-4 episodes per day of BTCP. INTERVENTION: all patients entered into a 16-week treatment phase after undergoing a dose-titration phase with FPNS. MAIN OUTCOME MEASURES: safety and tolerability were assessed by adverse events (AEs) and by nasal tolerability assessments. Consistency of effect was monitored through additional rescue medication use and FPNS dose change. RESULTS: four hundred three patients were included in the safety analyses. Of these, 356 patients entered the treatment phase and 110 patients completed the study. FPNS was self-administered for 42,227 episodes. During the treatment phase, 99 patients (24.6 percent) reported treatment-related AEs; most were mild or moderate and typical of opioids. Serious AEs were reported by 61 patients (15.1 percent), but only five were considered related to study drug. Of the 80 deaths that occurred during this study, one was assessed as possibly related to study drug. Nasal assessments revealed no significant local effects. No additional rescue medication was required after 94 percent of FPNS-treated episodes. More than 90 percent of patients required no increase in their initial dose of FPNS. CONCLUSIONS: FPNS use for BTCP was associated with AEs, typical of opioids, with no evidence of nasal toxicity. A large proportion of BTCP episodes were treated with a single dose, and doses remained stable over the 4-month period.