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Article: Don't sell out safety: a call to preserve risk evaluation and mitigation strategies to reduce harm to patients and the public in the U.S.

Worthy, Stacey L

Journal of pharmaceutical policy and practice

2016 Volume 9, Page(s) 2

Abstract: Background: As medicines are becoming more targeted and complex in the U.S., ensuring patients' ... programs.: Methods: The author reviewed U.S. legislation, statutes, case law, government agency policies ...

Abstract	Background: As medicines are becoming more targeted and complex in the U.S., ensuring patients' safe use of medications with known dangerous risks is critical for public health and safety. Therefore, the Risk Evaluation and Mitigation Strategies (REMS) program is more important than ever. The REMS programs mandates that manufacturers utilize tools to manage known or potential serious risks (e.g., death, severe birth defects, prolonged hospitalization) associated with certain drugs while still making these medications available to patients with unmet medical needs. Yet, recently federal policy makers have proposed legislation to force manufacturers to sell medications with known serious risks in a manner that weakens the medications' REMS programs. Methods: The author reviewed U.S. legislation, statutes, case law, government agency policies and guidelines, scholarly articles, and news stories published between January 1, 2004 and December 1, 2015 and provided legal and policy analysis. Results: REMS are necessary to make medications with known severe risks available to certain patient populations for whom treatment may not be available otherwise. Conclusion: In order to ensure that proper safety measures are preserved and medications with known risks are not diverted to parties who will not follow safety requirements, legislation should not be passed to require a forced sale of drugs subject to REMS with restricted distribution for bioequivalence testing purposes. Generic manufacturers must be held to the same REMS safety standards as brand manufacturers. Systems currently in place adequately balance risk and safety.
Language	English
Publishing date	2016-01-21
Publishing country	England
Document type	Journal Article
ZDB-ID	2734772-2
ISSN	2052-3211
ISSN	2052-3211
DOI	10.1186/s40545-016-0051-0
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Article ; Online: Mitochondrial Genomes from New Zealand’s Extinct Adzebills (Aves

Alexander P. Boast / Brendan Chapman / Michael B. Herrera / Trevor H. Worthy / R. Paul Scofield / Alan J. D. Tennyson / Peter Houde / Michael Bunce / Alan Cooper / Kieren J. Mitchell

Diversity, Vol 11, Iss 2, p

Aptornithidae: Aptornis ) Support a Sister-Taxon Relationship with the Afro-Madagascan Sarothruridae

2019 Volume 24

Abstract: ... suggests that the adzebill’s near relatives were formerly more widespread. In addition, our estimate ...

Abstract	The recently extinct New Zealand adzebills (Aptornithidae, Aptornis spp.) were an enigmatic group of large flightless birds that have long eluded precise taxonomic assignment as they do not closely resemble any extant birds. Adzebills were nearly wingless, weighed approximately 16⁻19 kg, and possessed massive adze-like reinforced bills whose function remains unknown. Using hybridisation enrichment and high-throughput sequencing of DNA extracted from subfossil bone and eggshell, near-complete mitochondrial genomes were successfully assembled from the two Quaternary adzebill species: the North Island Adzebill ( Aptornis otidiformis ) and South Island Adzebill ( A. defossor ). Molecular phylogenetic analyses confirm that adzebills are members of the Ralloidea (rails and allies) and are sister-taxon to the Sarothruridae, which our results suggest comprises the Madagascan wood rails ( Mentocrex , two likely sp.) in addition to the tiny (<50 gram) rail-like Afro-Madagascan flufftails ( Sarothrura , 9 spp.). Node age estimates indicate that the split between adzebills and Sarothruridae occurred ~39.6 Ma, suggesting that the ancestors of the adzebills arrived in New Zealand by long-distance dispersal rather than continental vicariance. This newly identified biogeographic link between physically distant New Zealand and Afro-Madagascar, echoed by the relationship between the New Zealand kiwi (Apterygiformes) and Madagascan elephant-birds (Aepyornithiformes), suggests that the adzebill’s near relatives were formerly more widespread. In addition, our estimate for the divergence time between the two Quaternary adzebill species (0.2⁻2.3 Ma) coincides with the emergence of a land-bridge between the North and South islands of New Zealand (ca. 1.5⁻2 Ma). This relatively recent divergence suggests that North Island adzebills are the result of a relatively recent dispersal from the South Island, from which the earliest (Miocene) adzebill fossil has been described.
Keywords	Adzebill ; Aptornis ; New Zealand ; ancient DNA ; phylogenetics ; Biology (General) ; QH301-705.5
Subject code	590
Language	English
Publishing date	2019-02-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Mitochondrial Genomes from New Zealand’s Extinct Adzebills (Aves: Aptornithidae: <i>Aptornis</i>) Support a Sister-Taxon Relationship with the Afro-Madagascan Sarothruridae

Boast, Alexander P / Bunce, Michael / Chapman, Brendan / Cooper, Alan / Herrera, Michael B / Houde, Peter / Mitchell, Kieren J / Scofield, R. Paul / Tennyson, Alan J. D / Worthy, Trevor H

Diversity. 2019 Feb. 15, v. 11, no. 2

2019

Abstract: ... suggests that the adzebill’s near relatives were formerly more widespread. In addition, our estimate ...

Abstract	The recently extinct New Zealand adzebills (Aptornithidae, Aptornis spp.) were an enigmatic group of large flightless birds that have long eluded precise taxonomic assignment as they do not closely resemble any extant birds. Adzebills were nearly wingless, weighed approximately 16–19 kg, and possessed massive adze-like reinforced bills whose function remains unknown. Using hybridisation enrichment and high-throughput sequencing of DNA extracted from subfossil bone and eggshell, near-complete mitochondrial genomes were successfully assembled from the two Quaternary adzebill species: the North Island Adzebill (Aptornis otidiformis) and South Island Adzebill (A. defossor). Molecular phylogenetic analyses confirm that adzebills are members of the Ralloidea (rails and allies) and are sister-taxon to the Sarothruridae, which our results suggest comprises the Madagascan wood rails (Mentocrex, two likely sp.) in addition to the tiny (<50 gram) rail-like Afro-Madagascan flufftails (Sarothrura, 9 spp.). Node age estimates indicate that the split between adzebills and Sarothruridae occurred ~39.6 Ma, suggesting that the ancestors of the adzebills arrived in New Zealand by long-distance dispersal rather than continental vicariance. This newly identified biogeographic link between physically distant New Zealand and Afro-Madagascar, echoed by the relationship between the New Zealand kiwi (Apterygiformes) and Madagascan elephant-birds (Aepyornithiformes), suggests that the adzebill’s near relatives were formerly more widespread. In addition, our estimate for the divergence time between the two Quaternary adzebill species (0.2–2.3 Ma) coincides with the emergence of a land-bridge between the North and South islands of New Zealand (ca. 1.5–2 Ma). This relatively recent divergence suggests that North Island adzebills are the result of a relatively recent dispersal from the South Island, from which the earliest (Miocene) adzebill fossil has been described.
Keywords	age determination ; ancestry ; Aves ; birds ; DNA ; egg shell ; fossils ; geographical distribution ; high-throughput nucleotide sequencing ; hybridization ; islands ; Miocene epoch ; mitochondrial genome ; phylogeny ; wood ; New Zealand
Language	English
Dates of publication	2019-0215
Publishing place	Multidisciplinary Digital Publishing Institute
Document type	Article
ZDB-ID	2518137-3
ISSN	1424-2818
ISSN	1424-2818
DOI	10.3390/d11020024
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Article: (with research data) Ancient mitochondrial genomes clarify the evolutionary history of New Zealand’s enigmatic acanthisittid wrens

Mitchell, Kieren J / Alan Cooper / Bastien Llamas / Jamie R. Wood / Olga Kardailsky / Patricia A. McLenachan / R. Paul Scofield / Trevor H. Worthy

Molecular phylogenetics and evolution. 2016 Sept., v. 102

2016

Abstract: ... Early Oligocene origin of the basal Lyall’s wren (Traversia) lineage, which would imply ...

Abstract	The New Zealand acanthisittid wrens are the sister-taxon to all other “perching birds” (Passeriformes) and – including recently extinct species – represent the most diverse endemic passerine family in New Zealand. Consequently, they are important for understanding both the early evolution of Passeriformes and the New Zealand biota. However, five of the seven species have become extinct since the arrival of humans in New Zealand, complicating evolutionary analyses. The results of morphological analyses have been largely equivocal, and no comprehensive genetic analysis of Acanthisittidae has been undertaken. We present novel mitochondrial genome sequences from four acanthisittid species (three extinct, one extant), allowing us to resolve the phylogeny and revise the taxonomy of acanthisittids. Reanalysis of morphological data in light of our genetic results confirms a close relationship between the extant rifleman (Acanthisitta chloris) and an extinct Miocene wren (Kuiornis indicator), making Kuiornis a useful calibration point for molecular dating of passerines. Our molecular dating analyses reveal that the stout-legged wrens (Pachyplichas) diverged relatively recently from a more gracile (Xenicus-like) ancestor. Further, our results suggest a possible Early Oligocene origin of the basal Lyall’s wren (Traversia) lineage, which would imply that Acanthisittidae survived the Oligocene marine inundation of New Zealand and therefore that the inundation was not complete.
Keywords	birds ; extinct species ; genetic techniques and protocols ; humans ; mitochondrial genome ; new family ; nucleotide sequences ; phylogeny ; Troglodytidae ; New Zealand
Language	English
Dates of publication	2016-09
Size	p. 295-304.
Publishing place	Elsevier Inc.
Document type	Article
ZDB-ID	33610-5
ISSN	1095-9513 ; 1055-7903
ISSN (online)	1095-9513
ISSN	1055-7903
DOI	10.1016/j.ympev.2016.05.038
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Article ; Online: A new look at an old Australian raptor places Taphaetus lacertosus de Vis 1905 in the Old World vultures (Accipitridae: Aegypiinae).

Mather, Ellen K / Lee, Michael S Y / Worthy, Trevor H

Zootaxa

2022 Volume 5168, Issue 1, Page(s) 1–23

Abstract: The Australian Pleistocene fossil record of the Accipitridae (hawks, eagles and Old World vultures) is sparse and poorly known. Only two extinct confirmed accipitrid species have been described for this time period; both have received little ... ...

Abstract	The Australian Pleistocene fossil record of the Accipitridae (hawks, eagles and Old World vultures) is sparse and poorly known. Only two extinct confirmed accipitrid species have been described for this time period; both have received little investigation since their description. One is Taphaetus lacertosus de Vis, 1905, described from a distal humerus and a quadrate from north-eastern South Australia. While this species was verified as an accipitrid in subsequent studies, its more precise taxonomic affinities have remained conjectural. In this study, a new analysis incorporating newly referred material and phylogenetic analyses using a wide range of accipitriforms reveals that the lectotype humerus of T. lacertosus is an Old World vulture in the subfamily Aegypiinae. The associated quadrate, one of two original syntypes from which de Vis named this species, is of an indeterminate species of ardeid. We erect the novel genus Cryptogyps, to accommodate the species lacertosus, as it cannot be placed in Taphaetus de Vis, 1891, because the type species of this genus, Uroaetus brachialis de Vis, 1889, was transferred back to the genus Uroaetus, a synonym of Aquila Brisson, by de Vis in 1905. Further, U. brachialis is now considered a synonym of Aquila audax (Latham, 1801). Moreover, Taphaetus de Vis, 1891 is a senior homonym of Taphaetus de Vis, 1905, type species Taphaetus lacertosus de Vis, 1905, making the 1905 version of the genus unavailable. Newly referred fossils from Wellington Caves (NSW) and the Nullarbor Plains (WA) reveal this taxon had a wide geographical range across Pleistocene Australia. The referred tarsometatarsus lacks hyper-developed trochleae, indicating that Cryptogyps lacertosus (de Vis, 1905) comb. nov., was probably a scavenger like other aegypiines. Identification of Cryptogyps lacertosus as an aegypiine significantly expands the palaeogeographical range of the Old World vultures, hitherto unknown in Australia. The avian guild of large, obligate scavenging birds of prey, is currently absent in the modern Australian biota, but its former presence is not surprising given the megafauna-rich communities of the Pleistocene.
MeSH term(s)	Animals ; Australia ; Eagles ; Fossils ; Phylogeny ; Raptors
Language	English
Publishing date	2022-07-20
Publishing country	New Zealand
Document type	Journal Article
ISSN	1175-5334
ISSN (online)	1175-5334
DOI	10.11646/zootaxa.5168.1.1
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Article: The S segment of Punta Toro virus (Bunyaviridae, Phlebovirus) is a major determinant of lethality in the Syrian hamster and codes for a type I interferon antagonist.

Perrone, Lucy A / Narayanan, Krishna / Worthy, Melissa / Peters, C J

Journal of virology

2007 Volume 81, Issue 2, Page(s) 884–892

Abstract: ... The S segment was revealed to be a critical genome segment, determining lethality with log(10) 50 ... lethal doses for each PTV genotype as follows (L/M/S convention): A/A/A, <0.7; B/A/A, <0.7; A/B/A, 1.5; B/B ... of the IFN-beta promoter. Expression of the PTV Adames NSs protein, encoded by the S RNA segment, inhibited ...

Abstract	Two strains of Punta Toro virus (PTV), isolated from febrile humans in Panama, cause a differential pathogenesis in Syrian hamsters, which could be a useful model for understanding the virulence characteristics and differential outcomes in other phleboviral infections such as Rift Valley fever virus. Genetic reassortants produced between the lethal Adames (A/A/A) and nonlethal Balliet (B/B/B) strains were used in this study to investigate viral genetic determinants for pathogenesis and lethality in the hamster model. The S segment was revealed to be a critical genome segment, determining lethality with log(10) 50% lethal doses for each PTV genotype as follows (L/M/S convention): A/A/A, <0.7; B/A/A, <0.7; A/B/A, 1.5; B/B/A, 2.2; B/A/B, 4.7; A/B/B, >4.7; A/A/B, >4.7; B/B/B, >4.7. In addition, the Adames strain inhibits the induction of alpha/beta interferon (IFN-alpha/beta) in vivo and in vitro and inhibits the activation of the IFN-beta promoter. Expression of the PTV Adames NSs protein, encoded by the S RNA segment, inhibited the virus-mediated induction of an IFN-beta promoter-driven reporter gene, suggesting that PTV NSs functions as a type I IFN antagonist. Taken together, these data indicate a mechanism of pathogenesis in which the suppression of the type I IFN response early during PTV infection leads to early and uncontrolled viral replication and, ultimately, hamster death. This study contributes to our understanding of Phlebovirus pathogenesis and identifies potential targets for immune modulation to increase host survival.
MeSH term(s)	Animals ; Cricetinae ; Disease Models, Animal ; Humans ; Interferon Type I/antagonists & inhibitors ; Mesocricetus ; Phlebotomus Fever/mortality ; Phlebotomus Fever/pathology ; Phlebotomus Fever/virology ; Phlebovirus/genetics ; Phlebovirus/metabolism ; Phlebovirus/pathogenicity ; Reassortant Viruses/genetics ; Reassortant Viruses/metabolism ; Reassortant Viruses/pathogenicity ; Viral Nonstructural Proteins/genetics ; Viral Nonstructural Proteins/metabolism ; Virulence
Chemical Substances	Interferon Type I ; Viral Nonstructural Proteins
Language	English
Publishing date	2007-01
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	80174-4
ISSN	1098-5514 ; 0022-538X
ISSN (online)	1098-5514
ISSN	0022-538X
DOI	10.1128/JVI.01074-06
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Article ; Online: Relationships Among Nursing Deans' Leadership Styles and Faculty Job Satisfaction Levels.

Worthy, Karen / Dawson, Robin M / Tavakoli, Abbas S

The Journal of nursing education

2020 Volume 59, Issue 2, Page(s) 68–75

Abstract: ... of nursing deans to determine whether they correlate with nursing faculty job satisfaction at public U.S ...

Abstract	Background: Although there is an abundance of empirical evidence on principals' leadership practices and teacher satisfaction in K-12 settings, a paucity of publications explore nursing faculty job satisfaction as influenced by leadership styles of academic deans. This research examined leadership styles of nursing deans to determine whether they correlate with nursing faculty job satisfaction at public U.S. universities with high research activity. Method: A descriptive, correlational study was conducted with electronic self-administered questionnaires. The sample was recruited from 24 universities; 303 questionnaires were returned. Results: Faculty perceived that nursing deans displayed transformational leadership style more frequently. Nursing faculty were moderately satisfied in their jobs, and they were more satisfied with nursing deans who practiced attributed idealized influence. Conclusion: Three types of leadership behaviors explained significant variance in faculty job satisfaction, indicating the need for training and development focused on effective leadership behaviors. [J Nurs Educ. 2020;59(2):68-75.].
MeSH term(s)	Administrative Personnel/psychology ; Adult ; Education, Nursing, Baccalaureate/organization & administration ; Faculty, Nursing/psychology ; Female ; Humans ; Job Satisfaction ; Leadership ; Male ; Schools, Nursing/organization & administration ; Surveys and Questionnaires ; United States
Language	English
Publishing date	2020-03-13
Publishing country	United States
Document type	Journal Article
ZDB-ID	410686-6
ISSN	1938-2421 ; 0148-4834
ISSN (online)	1938-2421
ISSN	0148-4834
DOI	10.3928/01484834-20200122-03
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Article ; Online: Corrigendum to "Could soil microplastic pollution exacerbate climate change? A meta-analysis of greenhouse gas emissions and global warming potential" [Environ. Res. 252 (2024) 118945/ ER-23-14694R1].

Iqbal, Shahid / Xu, Jianchu / Arif, Muhammad Saleem / Shakoor, Awais / Worthy, Fiona R / Gui, Heng / Khan, Sehroon / Bu, Dengpan / Nadir, Sadia / Ranjitkar, Sailesh

Environmental research

2024 Volume 252, Issue Pt 3, Page(s) 119031

Language	English
Publishing date	2024-04-30
Publishing country	Netherlands
Document type	Published Erratum
ZDB-ID	205699-9
ISSN	1096-0953 ; 0013-9351
ISSN (online)	1096-0953
ISSN	0013-9351
DOI	10.1016/j.envres.2024.119031
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Article ; Online: Could soil microplastic pollution exacerbate climate change? A meta-analysis of greenhouse gas emissions and global warming potential.

Iqbal, Shahid / Xu, Jianchu / Saleem Arif, Muhammad / Shakoor, Awais / Worthy, Fiona R / Gui, Heng / Khan, Sehroon / Bu, Dengpan / Nader, Sadia / Ranjitkar, Sailesh

Environmental research

2024 Volume 252, Issue Pt 2, Page(s) 118945

Abstract: Microplastics pollution and climate change are primarily investigated in isolation, despite their joint threat to the environment. Greenhouse gases (GHGs) are emitted during: the production of plastic and rubber, the use and degradation of plastic, and ... ...

Abstract	Microplastics pollution and climate change are primarily investigated in isolation, despite their joint threat to the environment. Greenhouse gases (GHGs) are emitted during: the production of plastic and rubber, the use and degradation of plastic, and after contamination of environment. This is the first meta-analysis to assess underlying causal relationships and the influence of likely mediators. We included 60 peer-reviewed empirical studies; estimating GHGs emissions effect size and global warming potential (GWP), according to key microplastics properties and soil conditions. We investigated interrelationships with microbe functional gene expression. Overall, microplastics contamination was associated with increased GHGs emissions, with the strongest effect (60%) on CH
Language	English
Publishing date	2024-04-16
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	205699-9
ISSN	1096-0953 ; 0013-9351
ISSN (online)	1096-0953
ISSN	0013-9351
DOI	10.1016/j.envres.2024.118945
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Article ; Online: Do Added Microplastics, Native Soil Properties, and Prevailing Climatic Conditions Have Consequences for Carbon and Nitrogen Contents in Soil? A Global Data Synthesis of Pot and Greenhouse Studies.

Iqbal, Shahid / Xu, Jianchu / Arif, Muhammad Saleem / Worthy, Fiona R / Jones, Davey L / Khan, Sehroon / Alharbi, Sulaiman Ali / Filimonenko, Ekaterina / Nadir, Sadia / Bu, Dengpan / Shakoor, Awais / Gui, Heng / Schaefer, Douglas Allen / Kuzyakov, Yakov

Environmental science & technology

2024

Abstract: Microplastics threaten soil ecosystems, strongly influencing carbon (C) and nitrogen (N) contents. Interactions between microplastic properties and climatic and edaphic factors are poorly understood. We conducted a meta-analysis to assess the interactive ...

Abstract	Microplastics threaten soil ecosystems, strongly influencing carbon (C) and nitrogen (N) contents. Interactions between microplastic properties and climatic and edaphic factors are poorly understood. We conducted a meta-analysis to assess the interactive effects of microplastic properties (type, shape, size, and content), native soil properties (texture, pH, and dissolved organic carbon (DOC)) and climatic factors (precipitation and temperature) on C and N contents in soil. We found that low-density polyethylene reduced total nitrogen (TN) content, whereas biodegradable polylactic acid led to a decrease in soil organic carbon (SOC). Microplastic fragments especially depleted TN, reducing aggregate stability, increasing N-mineralization and leaching, and consequently increasing the soil C/N ratio. Microplastic size affected outcomes; those <200 μm reduced both TN and SOC contents. Mineralization-induced nutrient losses were greatest at microplastic contents between 1 and 2.5% of soil weight. Sandy soils suffered the highest microplastic contamination-induced nutrient depletion. Alkaline soils showed the greatest SOC depletion, suggesting high SOC degradability. In low-DOC soils, microplastic contamination caused 2-fold greater TN depletion than in soils with high DOC. Sites with high precipitation and temperature had greatest decrease in TN and SOC contents. In conclusion, there are complex interactions determining microplastic impacts on soil health. Microplastic contamination always risks soil C and N depletion, but the severity depends on microplastic characteristics, native soil properties, and climatic conditions, with potential exacerbation by greenhouse emission-induced climate change.
Language	English
Publishing date	2024-05-03
Publishing country	United States
Document type	Journal Article
ISSN	1520-5851
ISSN (online)	1520-5851
DOI	10.1021/acs.est.3c10247
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