Health of fathers-to-be linked to pregnancy loss, study finds – News24

Research published inHuman Reproductionanalysed almost 1 million US pregnancies from 2009 to 2016. The findings of the study revealed that the more medical conditions men had, the higher the risk of the mother losing the baby.

"It's been known for some time that the health of mothers has an impact on the developing foetus and events at the time of birth. This is the first study to suggest that pregnancies sired by men with increasing numbers of medical conditions are at higher risk of ending in miscarriage, ectopic pregnancy or stillbirth, Professor Michael Eisenberg, who led the research, said in apress release.

In the group of men we studied, the risk of losing the pregnancy was 17% in couples where the father had no components of the metabolic syndrome but increased to 21% in couples where the father has one metabolic syndrome component, 23% where he has two, and 27% where he has three or more, said Eisenberg.

According to the research, the mechanism of how the father's health might affect the risk of pregnancy loss is not known but there is a link in the length of the pregnancy term and the fathers lifestyle choices.

"We hypothesise that the father's health and lifestyle could adversely affect the genetic make-up and expression in the sperm, and that this may alter how well the placenta functions," Eisenberg explained.

"If the placenta isn't working properly, then this could lead to the pregnancy losses that we observed. For instance, we know already that paternal smoking and diet can affect sperm quality."

The researchers are now aiming to look at integrating paternal health in future studies and hope to find the mechanism that causes fathers poor health to be associated with loss of pregnancy.

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Health of fathers-to-be linked to pregnancy loss, study finds - News24

Hormone metabolites found in poop give researchers new insight into whale stress – The News Guard

Poop samples are an effective, non-invasive tool for monitoring gray whale reproduction, stress and other physiological responses, a new study from Oregon State University shows.

Researchers from OSUs Geospatial Ecology of Marine Megafauna Laboratory collected 158 fecal, commonly known as poop, samples from Eastern North Pacific gray whales off the coast of Oregon between 2016 and 2018 and used the samples to assess endocrine levels and establish hormone baselines for stress and reproduction in the animals.

The study is believed to be the first to use fecal samples as an endocrine assessment tool in Eastern North Pacific gray whales. Fecal samples can provide a wide range of important information about whale health in a noninvasive way, said Leigh Torres, an associate professor in OSUs Marine Mammal Institute and director of the GEMM Lab.

Understanding whale physiology is really important to evaluate how human, activities impact whales, Torres said. But it is really, really hard to study whale physiology. You cant observe most physiological responses. And you cant just ask a whale: Are you stressed out? So we have to get creative.

The findings were published this month in the journal Conservation Physiology. The papers lead author is Leila Soledade Lemos, who recently completed her doctorate in Oregon States Department of Fisheries and Wildlife and worked with Torres in the GEMM Lab. Lemos is now a postdoctoral associate at Florida International University.

Most gray whales migrate from breeding grounds in Mexico to feeding grounds in the Bering and Chukchi seas between Alaska and Russia, where they spend the summer. Torres and her team study a distinct population of gray whales known as the Pacific Coast Feeding Group, which spend the summer months feeding in coastal waters of Oregon, as well as northern California, Washington and southern Canada.

Torres and her research team have been observing and conducting annual health check-ups on this population since 2016. When they spot a defecating whale from a boat or via a drone, they follow in the animals wake and use nets to capture samples. The drones are also used to capture images of the whales, allowing researchers to monitor the animals body condition and behavior.

Researchers used the collected fecal samples to analyze four hormone metabolites: two reproductive hormones; a stress hormone; and thyroid, which can indicate nutrition-related stress.

With this data, the researchers were able to see how hormones fluctuated with a whales age and sex and establish baseline hormone levels for different cycles of a whales life, including during pregnancy.

This was a first step to understanding how hormones vary through a whales life cycle and in times of stress, Lemos said. It helps us establish baselines and ranges of hormone levels.

The researchers also were able to document a stressful event in a specific whale. They collected a fecal sample from a whale within 24 hours of a documented injury from a propeller or vessel strike. The fecal sample collected after the injury showed a spike in stress hormone levels, almost three times higher than this whales stress levels on previous days without the injury.

The researchers also captured a fecal sample from a mature male who was engaged in competitive reproductive behavior with another male whale. That whales testosterone level was very high and may reflect the typical hormone levels of adult breeding males. The researchers ability to connect fecal samples to specific individual whales adds important context to the data to help understand what drives hormone variation, Torres said.

Researchers have continued to collect fecal samples over the last two summers and will continue to analyze hormones as part of their broader work on whale health.

The researchers ultimate goal is to understand how variations in human-generated ocean noise impacts whale health, Torres said. Analysis of fecal samples is emerging as an important new tool for understanding how different stressors impact whale physiology. They also hope to use the endocrine information to better understand the role of nutrition and changes in diet on overall whale health.

Our ability to link hormone variation to an individuals condition is really a significant advance for the study of whale physiology, Torres said. All of our future work on impacts of disturbance events will build on this foundation. Its super exciting to be able to use these tools to think about whale life in a holistic way.

The research was supported in part by NOAAs National Marine Fisheries Service Office of Science and Technology Ocean Acoustics Program; Oregon Sea Grant; and the OSU Marine Mammal Institute. Lemos received funding from Brazils Science Without Borders Program and its National Council for Scientific and Technological Development (CNPq).

Additional co-authors include Todd Chandler of Oregon State; Kathleen Hunt of the Smithsonian-Mason School of Conservation; and Amy Olsen, Angela Smith and Shawn Larson of the Seattle Aquarium.

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Lilly Presents Positive Primary Outcome Data from monarchE that Builds on Previous Definitive Analysis for Verzenio – PRNewswire

INDIANAPOLIS, Dec. 9, 2020 /PRNewswire/ --Eli Lilly and Company (NYSE: LLY) today announced additional data from a pre-planned primary outcome analysis from the Phase 3 monarchE trial that showed Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) decreased the risk of breast cancer recurrence by 28.7 percent compared to standard adjuvant ET alone for people with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (HR: 0.713; 95% CI: 0.583, 0.871; p = 0.0009). This statistically significant improvement corresponds to a three percent difference in the two-year rate of invasive disease-free survival (IDFS) between arms (92.3 percent in the Verzenio arm and 89.3 percent in the control arm). The data presented today during the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) included an additional 3.6 months of follow-up since the pre-planned interim analysis results announced in September 2020, and more than 1,400 patients have completed two years of treatment since the start of the study.

The timing of the primary outcome analysis was driven by the number of IDFS events observed in the intent-to-treat population across both arms as prespecified in the study's statistical analysis plan.The statistically significant benefit observed was consistent across all pre-specified subgroups. The median follow up was approximately 19.1 months.

The addition of Verzenio to ET also resulted in an improvement in distant relapse-free survival (DRFS), or time to developing breast cancer that has spread to other parts of the body. The combination reduced the risk of developing metastatic disease by 31.3 percent compared to 28.3 percent at interim analysis (HR: 0.687; 95% CI: 0.551, 0.858). Safety data from monarchE were consistent with the known safety profile of Verzenio and no new safety signals were observed. Compared to the interim analysis results, there were minimal increases in adverse events.

"As the monarchE data have matured, we have seen an improvement in the reduction of risk of recurrence for people with HR+, HER2- high risk early breast cancer," said Priya Rastogi, M.D., associate professor at the University of Pittsburgh School of Medicine, medical oncologist at UPMC Hillman Cancer Center and medical director of the National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation. "With more than 1,400 patients completing two years of treatment, we are pleased to see the curves continue to separate, as reflected by the numerically greater hazard ratio estimates for both invasive disease-free survival and distant relapse-free survival in the primary outcome analysis."

monarchE randomized 5,637 patients with HR+, HER2- high risk early breast cancer from more than 600 sites in 38 countries. High risk was defined by cancer that spread to the lymph nodes, a large tumor size, or high cellular proliferation (as determined by tumor grade or Ki-67 index). Patients were treated for two years (treatment period) or until meeting criteria for discontinuation. After the treatment period, all patients will continue ET for five to 10 years, as clinically indicated.

"The monarchE primary outcome data builds on the significance of the results of the interim analysis with a 28.7 percent reduction in the risk of recurrence for patients with HR+, HER2-, high risk early breast cancer," said Maura Dickler, M.D., vice president, late phase development, Lilly Oncology. "We are extremely pleased that these results continue to be strong and reinforce Verzenio as the only CDK4 & 6 inhibitor with positive results in the early breast cancer setting. We thank all those who participated in the trial and we are committed to making Verzenio available for these patients as quickly as possible."

A key secondary analysis evaluated the IDFS treatment benefit of patients enrolled in monarchE based on Ki-67 index. In patients whose tumors had high Ki-67 (20%), Verzenio with ET also significantly decreased the risk of breast cancer recurrence by 30.9 percent, compared to those who received ET alone (HR: 0.691; 95% CI: 0.519, 0.920). Ki-67 is a biomarker of high cell proliferation and increased risk of recurrence. This is the first time a prespecified threshold of 20% for Ki-67 has been used to prospectively evaluate the utility of central Ki-67 using a standardized assay in a phase III registration trial.These results suggest that Ki-67 20% could be used together with clinicopathological features of nodal involvement, tumor size, and grade, to identify patients with HR+, HER2-, early breast cancer at high risk of recurrence.

All patients on monarchE will continue to be followed to assess overall survival and other endpoints. Lilly will submit the monarchE data to regulatory authorities before the end of 2020.

About the monarchE Study monarchE is a Phase 3, multicenter, randomized, open-label trial that enrolled 5,637 patients with HR+, HER2- node-positive, high risk early breast cancer. Patients were randomized 1:1 to Verzenio (150 mg twice daily) plus standard adjuvant endocrine therapy or standard adjuvant endocrine therapy alone. Patients were treated for two years (treatment period) or until meeting criteria for discontinuation. After the treatment period, all patients will continue on endocrine therapy for five to 10 years, as clinically indicated. The primary objective is invasive disease-free survival (IDFS) defined according to the Standard Definitions for Efficacy Endpoints (STEEP) criteria. In adjuvant breast cancer trials, this includes the length of time before any cancer comes back, a new cancer develops or death. Secondary objectives include distant relapse-free survival, overall survival, safety, pharmacokinetics and health outcomes.

High risk was specifically defined as women (any menopausal status) and men with resected HR+, HER2- invasive early breast cancer with either 4 pathologically positive axillary lymph nodes (ALNs) or 1 to 3 positive ALNs and at least one of the following high-risk features: primary invasive tumor size 5 cm, histological grade 3 tumor, or central Ki-67 index 20%. If applicable, patients must have also completed adjuvant chemotherapy and radiotherapy prior to enrolling and have recovered from all acute side effects.

About Early Breast Cancer Breast cancer is the most common cancer among women worldwide.1 An estimated 90% of all breast cancer is diagnosed at an early stage.2 Approximately 70% of all breast cancers are HR+, HER2-, the most common subtype.3 Even within this subtype, HR+, HER2- breast cancer is a complex disease, and many factors such as if the cancer has spread to the lymph nodes and the biology of the tumor can impact the risk of recurrence. Approximately 30% of people diagnosed with HR+ early breast cancer are at risk of their cancer returning, potentially to incurable metastatic disease.4

About Verzenio (abemaciclib) Verzenio (abemaciclib) is an inhibitor of cyclin-dependent kinases (CDK)4 & 6, which are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4 & 6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation.

In vitro, continuous exposure to Verzenio inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, resulting in senescence and apoptosis (cell death). Preclinically, Verzenio dosed daily without interruption resulted in reduction of tumor size. Inhibiting CDK4 & 6 in healthy cells can result in side effects, some of which may be serious. Clinical evidence also suggests that Verzenio crosses the blood-brain barrier. In patients with advanced cancer, including breast cancer, concentrations of Verzenio and its active metabolites (M2 and M20) in cerebrospinal fluid are comparable to unbound plasma concentrations.

Verzenio is Lilly's first solid oral dosage form to be made using a faster, more efficient process known as continuous manufacturing. Continuous manufacturing is a new and advanced type of manufacturing within the pharmaceutical industry, and Lilly is one of the first companies to use this technology.

INDICATION Verzenio is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer:

IMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib)

Diarrhea occurred in 81% of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3, 86% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and 90% of patients receiving Verzenio alone in MONARCH 1. Grade 3 diarrhea occurred in 9% of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3, 13% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and in 20% of patients receiving Verzenio alone in MONARCH 1. Episodes of diarrhea have been associated with dehydration and infection.

Diarrhea incidence was greatest during the first month of Verzenio dosing. In MONARCH 3, the median time to onset of the first diarrhea event was 8 days, and the median duration of diarrhea for Grades 2 and 3 were 11 and 8 days, respectively. In MONARCH 2, the median time to onset of the first diarrhea event was 6 days, and the median duration of diarrhea for Grades 2 and 3 were 9 days and 6 days, respectively. In MONARCH 3, 19% of patients with diarrhea required a dose omission and 13% required a dose reduction. In MONARCH 2, 22% of patients with diarrhea required a dose omission and 22% required a dose reduction. The time to onset and resolution for diarrhea were similar across MONARCH 3, MONARCH 2, and MONARCH 1.

Instruct patients that at the first sign of loose stools, they should start antidiarrheal therapy such as loperamide, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue Verzenio until toxicity resolves to Grade 1, and then resume Verzenio at the next lower dose.

Neutropenia occurred in 41% of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3, 46% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and 37% of patients receiving Verzenio alone in MONARCH 1. A Grade 3 decrease in neutrophil count (based on laboratory findings) occurred in 22% of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3, 32% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and in 27% of patients receiving Verzenio alone in MONARCH 1. In MONARCH 3, the median time to first episode of Grade 3 neutropenia was 33 days, and in MONARCH 2 and MONARCH 1, was 29 days. In MONARCH 3, median duration of Grade 3 neutropenia was 11 days, and for MONARCH 2 and MONARCH 1 was 15 days.

Monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

Febrile neutropenia has been reported in <1% of patients exposed to Verzenio in the MONARCH studies. Two deaths due to neutropenic sepsis were observed in MONARCH 2. Inform patients to promptly report any episodes of fever to their healthcare provider.

Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. Across clinical trials (MONARCH 1, MONARCH 2, MONARCH 3), 3.3% of Verzenio-treated patients had ILD/pneumonitis of any grade, 0.6% had Grade 3 or 4, and 0.4% had fatal outcomes. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported.

Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded by means of appropriate investigations.

Dose interruption or dose reduction is recommended in patients who develop persistent or recurrent Grade 2 ILD/pneumonitis. Permanently discontinue Verzenio in all patients with grade 3 or 4 ILD/pneumonitis.

Grade 3 increases in alanine aminotransferase (ALT) (6% versus 2%) and aspartate aminotransferase (AST) (3% versus 1%) were reported in the Verzenio and placebo arms, respectively, in MONARCH 3. Grade 3 increases in ALT (4% versus 2%) and AST (2% versus 3%) were reported in the Verzenio and placebo arms respectively, in MONARCH 2.

In MONARCH 3, for patients receiving Verzenio plus an aromatase inhibitor with Grade 3 increases in ALT or AST, median time to onset was 61 and 71 days, respectively, and median time to resolution to Grade <3 was 14 and 15 days, respectively. In MONARCH 2, for patients receiving Verzenio plus fulvestrant with Grade 3 increases in ALT or AST, median time to onset was 57 and 185 days, respectively, and median time to resolution to Grade <3 was 14 and 13 days, respectively.

For assessment of potential hepatotoxicity, monitor liver function tests (LFTs) prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, dose discontinuation, or delay in starting treatment cycles is recommended for patients who develop persistent or recurrent Grade 2, or Grade 3 or 4, hepatic transaminase elevation.

Venous thromboembolic events were reported in 5% of patients treated with Verzenio plus an aromatase inhibitor as compared to 0.6% of patients treated with an aromatase inhibitor plus placebo in MONARCH 3. Venous thromboembolic events were reported in 5% of patients treated with Verzenio plus fulvestrant in MONARCH 2 as compared to 0.9% of patients treated with fulvestrant plus placebo. Venous thromboembolic events included deep vein thrombosis, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian and axillary vein thrombosis, and inferior vena cava thrombosis. Across the clinical development program, deaths due to venous thromboembolism have been reported. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate.

Verzenio can cause fetal harm when administered to a pregnant woman based on findings from animal studies and the mechanism of action. In animal reproduction studies, administration of abemaciclib to pregnant rats during the period of organogenesis caused teratogenicity and decreased fetal weight at maternal exposures that were similar to the human clinical exposure based on area under the curve (AUC) at the maximum recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Verzenio and for at least 3 weeks after the last dose. There are no data on the presence of Verzenio in human milk or its effects on the breastfed child or on milk production. Advise lactating women not to breastfeed during Verzenio treatment and for at least 3 weeks after the last dose because of the potential for serious adverse reactions in breastfed infants. Based on findings in animals, Verzenio may impair fertility in males of reproductive potential.

The most common adverse reactions (all grades, 10%) observed in MONARCH 3 for Verzenio plus anastrozole or letrozole and 2% higher than placebo plus anastrozole or letrozole vs placebo plus anastrozole or letrozole were diarrhea (81% vs 30%), neutropenia (41% vs 2%), fatigue (40% vs 32%), infections (39% vs 29%), nausea (39% vs 20%), abdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs 5%), alopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia (21% vs 2%), creatinine increased (19% vs 4%), constipation (16% vs 12%), ALT increased (16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), pruritus (13% vs 9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight decreased (10% vs 3%), influenza-like illness (10% vs 8%), and thrombocytopenia (10% vs 2%).

The most common adverse reactions (all grades, 10%) observed in MONARCH 2 for Verzenio plus fulvestrant and 2% higher than placebo plus fulvestrant vs placebo plus fulvestrant were diarrhea (86% vs 25%), neutropenia (46% vs 4%), fatigue (46% vs 32%), nausea (45% vs 23%), infections (43% vs 25%), abdominal pain (35% vs 16%), anemia (29% vs 4%), leukopenia (28% vs 2%), decreased appetite (27% vs 12%), vomiting (26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 3%), thrombocytopenia (16% vs 3%), alopecia (16% vs 2%), stomatitis (15% vs 10%), ALT increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%), dizziness (12% vs 6%), AST increased (12% vs 7%), peripheral edema (12% vs 7%), creatinine increased (12% vs <1%), rash (11% vs 4%), pyrexia (11% vs 6%), and weight decreased (10% vs 2%).

The most common adverse reactions (all grades, 10%) observed in MONARCH 1 with Verzenio were diarrhea (90%), fatigue (65%), nausea (64%), decreased appetite (45%), abdominal pain (39%), neutropenia (37%), vomiting (35%), infections (31%), anemia (25%), thrombocytopenia (20%), headache (20%), cough (19%), leukopenia (17%), constipation (17%), arthralgia (15%), dry mouth (14%), weight decreased (14%), stomatitis (14%), creatinine increased (13%), alopecia (12%), dysgeusia (12%), pyrexia (11%), dizziness (11%), and dehydration (10%).

The most frequently reported 5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 3 were neutropenia (22% vs 2%), diarrhea (9% vs 1%), leukopenia (8% vs <1%), ALT increased (7% vs 2%), and anemia (6% vs 1%).

The most frequently reported 5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 2 were neutropenia (27% vs 2%), diarrhea (13% vs <1%), leukopenia (9% vs 0%), anemia (7% vs 1%), and infections (6% vs 3%).

The most frequently reported 5% Grade 3 or 4 adverse reactions from MONARCH 1 with Verzenio were neutropenia (24%), diarrhea (20%), fatigue (13%), infections (7%), leukopenia (6%), anemia (5%), and nausea (5%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 3 in 10% for Verzenio plus anastrozole or letrozole and 2% higher than placebo plus anastrozole or letrozole vs placebo plus anastrozole or letrozole were increased serum creatinine (98% vs 84%; 2% vs 0%), decreased white blood cells (82% vs 27%; 13% vs <1%), anemia (82% vs 28%; 2% vs 0%), decreased neutrophil count (80% vs 21%; 22% vs 3%), decreased lymphocyte count (53% vs 26%; 8% vs 2%), decreased platelet count (36% vs 12%; 2% vs <1%), increased ALT (48% vs 25%; 7% vs 2%), and increased AST (37% vs 23%; 4% vs <1%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 2 in 10% for Verzenio plus fulvestrant and 2% higher than placebo plus fulvestrant vs placebo plus fulvestrant were increased serum creatinine (98% vs 74%; 1% vs 0%), decreased white blood cells (90% vs 33%; 23% vs 1%), decreased neutrophil count (87% vs 30%; 33% vs 4%), anemia (84% vs 33%; 3% vs <1%), decreased lymphocyte count (63% vs 32%; 12% vs 2%), decreased platelet count (53% vs 15%; 2% vs 0%), increased ALT (41% vs 32%; 5% vs 1%), and increased AST (37% vs 25%; 4% vs 4%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 1 were increased serum creatinine (98%; <1%), decreased white blood cells (91%; 28%), decreased neutrophil count (88%; 27%), anemia (68%; 0%), decreased lymphocyte count (42%; 14%), decreased platelet count (41%; 2%), increased ALT (31%; 3%), and increased AST (30%; 4%).

Strong and moderate CYP3A inhibitors increased the exposure of abemaciclib plus its active metabolites to a clinically meaningful extent and may lead to increased toxicity. Avoid concomitant use of the strong CYP3A inhibitor ketoconazole. Ketoconazole is predicted to increase the AUC of abemaciclib by up to 16-fold. In patients with recommended starting doses of 200 mg twice daily or 150 mg twice daily, reduce the Verzenio dose to 100 mg twice daily with concomitant use of strong CYP3A inhibitors other than ketoconazole. In patients who have had a dose reduction to 100 mg twice daily due to adverse reactions, further reduce the Verzenio dose to 50 mg twice daily with concomitant use of strong CYP3A inhibitors. If a patient taking Verzenio discontinues a strong CYP3A inhibitor, increase the Verzenio dose (after 3 to 5 half-lives of the inhibitor) to the dose that was used before starting the inhibitor. With concomitant use of moderate CYP3A inhibitors, monitor for adverse reactions and consider reducing the Verzenio dose in 50 mg decrements. Patients should avoid grapefruit products.

Avoid concomitant use of strong or moderate CYP3A inducers and consider alternative agents. Coadministration of strong or moderate CYP3A inducers decreased the plasma concentrations of abemaciclib plus its active metabolites and may lead to reduced activity.

With severe hepatic impairment (Child-Pugh Class C), reduce the Verzenio dosing frequency to once daily. The pharmacokinetics of Verzenio in patients with severe renal impairment (CLcr <30 mL/min), end stage renal disease, or in patients on dialysis is unknown. No dosage adjustments are necessary in patients with mild or moderate hepatic (Child-Pugh A or B) and/or renal impairment (CLcr 30-89 mL/min).

AL HCP ISI 17SEP2019

Please see full Prescribing Information for Verzenio.

About Lilly OncologyFor more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. To learn more about Lilly's commitment to people with cancer, please visit http://www.LillyOncology.com.

About Eli Lilly and CompanyLilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom.P-LLY

Lilly USA, LLC 2020. ALL RIGHTS RESERVED.

Verzenio is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

Lilly Forward-Looking StatementThis press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Verzenio (abemaciclib) as a treatment for patients with breast cancer and the expected timing of regulatory submissions relating to Verzenio, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of research, development, regulatory approval, and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that submission timelines will occur as planned, that Verzenio will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

1World Health Organization. Breast cancer: prevention and control. https://www.who.int/cancer/detection/breastcancer/en/index1.html. Accessed: November 19, 2020.2Howlader N, et al. SEER Cancer Statistics Review, 1975-2013. http://seer.cancer.gov/csr/1975_2013/. Accessed: November 19, 2020.3Howlader N, Altekruse S, Li C. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014;106(5).4Reinert T and Barrios CH. Optimal Management of Hormone Receptor Positive Metastatic Breast Cancer in 2016. Ther Adv Med Oncol. 2015;7(6):304-20.

SOURCE Eli Lilly and Company

http://www.lilly.com

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Lilly Presents Positive Primary Outcome Data from monarchE that Builds on Previous Definitive Analysis for Verzenio - PRNewswire

B.C. woman loses appeal to have second child by using late husbands sperm – Keremeos Review

A womans second attempt to be granted the legal right to use her late husbands sperm to have another child has been struck down in B.C.s Court of Appeal.

The woman, referred to as Ms. T., lost her husband after he died suddenly and unexpectedly, according to court documents made public on Wednesday (Nov. 25). The pair had been married for three years and had one child together.

While they had talked about growing their family, they never discussed what would happen if one or the other died specifically to do with posthumous use of their reproductive material.

On Wednesday, the appeals court was dealt the task of considering how Ms. Ts yearning to give her child a full biological sibling worked within the legal framework of the Assisted Human Reproduction Act. That legislation prohibits the removal of human reproductive material from a donor without the donors prior, informed or written consent.

In the initial hearing, in which a judge struck down Ms. Ts request, she argued that many people do not know about this legislation and that while the federal government contemplated rolling out education on this act, they have yet to provide any.

While the appeals judges agreed, they determined the aspects of required consent were clearly stipulated within the law.

Ms. T also argued that reproductive material in some instances has been recognized as property, citing a decision from 2016 involving the Genesis Fertility Clinic. The judges determined that in that instance, the donor who was suffering from a life-threatening medical condition had consented for the removal of his reproductive material while he was alive.

Although in that instance the written consent was not complete, there was enough evidence to show overall consent.

In their reasoning, the three appeals judges determined that Mr. T likely would have consented to the posthumous use of his reproductive material if he had considered the issue. However, granting the widow permission to use her husbands sperm would be contrary to the explicit language found within the act set to protect the donors interest, they ruled.

The appeal was dismissed.

I do so with regret, aware of the painful and tragic circumstances confronting Ms. Ts family, Justice Harris wrote in the rulings conclusion.

Given the circumstances, I would stay the order of this court for 60 days to permit the parties to consider their position on an appeal to the Supreme Court of Canada.

Court

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B.C. woman loses appeal to have second child by using late husbands sperm - Keremeos Review

Evolution doesn’t work the way you think it does – Massive Science

Last month in book club we were talking about an adorable newborn baby we had just met over Zoom. Someone commented that the baby looks like their father. Another person piped up with an evolutionary explanation they had heard before newborn babies look more like their fathers so that the father will know theyre his and will help raise and protect them.

Some of us started wondering how something like that would even work. We agreed that this kind of paternal effect was possible and moved on. Later I looked it up only to learn that this popular hypothesis had been debunked nearly ten years ago.

Many of us have had conversations like this. In chatting about this or that, about babies, dating, or the mysterious lives of cats, someone brightly chimes "That's because of evolution!" It's easy to accept and internalize those ideas, re-hashing them at parties in an endless cycle.

This reflects a misunderstanding of both the process of science and the process of evolution. Any discussion of a scientific hypothesis to explain a pattern should ask first, "is the pattern real?" and second, "could anything else lead to the same pattern?" There is a fine line between its possible and its probable and the consequences of mistaking a possibility for the truth can be far-reaching.

Evolution is often treated as synonymous with natural selection, and natural selection is often boiled down to a single phrase: survival of the fittest. This oversimplification is easy to apply to everyday life but should we? If we dont carefully manage our assumptions and biases, we are in danger of the same sort of thinking that leads to Social Darwinism, in which Darwin's theory of natural selection is applied to justify social inequities between different groups of people. To prevent that, lets tease apart the concepts of evolution, natural selection, and fitness.

Evolution, in the broadest sense, means change over time. Societies evolve. Languages evolve. Technologies evolve. And species evolve, because DNA evolves.

Physical traits result from the production of various proteins in your cells. A gene is a piece of DNA that codes for a protein. Changes to DNA (mutations) create new versions of the same gene these versions are called alleles. Different alleles can make different proteins, or cause differences in how a certain protein manifests in the body we call this physical manifestation of gene products a phenotype.

Your phenotype for eye color is determined in part by how much of the protein melanin is produced and stored in the eye. Different combinations of alleles will lead to different amounts of melanin and different color phenotypes. Scientists used to think that eye color followed a simple inheritance pattern, because the allele for brown eyes is dominant over the allele for blue eyes. We know now that it is more complicated. The oversimplified version of the story led to the widespread, mistaken belief that two people with brown eyes could never have a child with blue eyes. Even in such a trivial trait as eye color, this misunderstanding of how inheritance works can have serious repercussions.

A child with heterochromia

Karl Fredrickson via Unsplash

Evolution determines the fate of any new mutation that occurs in a population. Evidence suggests that the original Homo sapiens all had brown eyes, and mutations created other alleles only more recently. On the molecular level, evolution is the change in allele frequencies in a population. Over time some populations evolved a high frequency of the allele for light eyes and consequently the light-eyed phenotype, but we cant know for sure what caused that evolution. Just because a phenotype is common in a given population or species does not mean it is adaptive or beneficial in that population's environment. It could be that the population just happened to be founded by individuals with that phenotype. This is a type of random evolution called the founder effect.

Some evolution is random, but not all. Humans, especially scientists, look for patterns and seek non-random explanations for natural phenomena. Our curiosity led to the discovery of natural selection. But to understand natural selection, you must first understand fitness.

In evolutionary biology, the word "fitness" is the capacity of an organism to survive and reproduce in a given environment. Individual fitness might be measured as the number of offspring an individual has over the course of their lifetime. The popular phrase survival of the fittest (notably not coined by Charles Darwin) doesn't mean much because it fails to account for reproduction. Survival alone will not lead to evolution if you dont contribute genes to the next generation. In social species like humans, this contribution can be indirect for example, helping to raise your sibling's kids increases your own fitness. Longer survival may or may not increase fitness, because it depends on the timing and frequency of reproduction. Fitness can also be measured as the overall reproductive rate of a given population. And most importantly: fitness is relative to the environment an individual that has high fitness in one environment might have low fitness in a different environment.

In an environment with infinite resources and minimal threats, most individuals would probably have the same fitness. Everyone would happily pass on their alleles, and the only cause of evolution would be random events. But we do not live in a world with infinite resources. Individuals need to compete for limited resources in their environment, and whoever is best able to acquire those resources is more likely to survive and reproduce. If there is a specific phenotype that helps individuals acquire and use resources more efficiently, individuals with that phenotype are likely to reproduce more than individuals with other phenotypes, and if it is heritable, that helpful phenotype will be more common in future generations. This change in frequency of a phenotype (and change in allele frequencies for the underlying genes) due to a fitness advantage is evolution by natural selection, otherwise known as adaptation.

One example of an adaptation in humans is the increased oxygen-carrying capacity of red blood cells in populations that live at high elevations. This phenotype is heritable and evolved (increased in frequency) in direct response to natural selection, because individuals with higher oxygen saturation have higher fitness at high altitude. Whether or not a phenotype is an adaptation depends on a) whether it confers a fitness advantage in its environment, and b) whether its function evolved because of that fitness advantage.

There are cases where the function of a phenotype confers a fitness advantage, but the trait did not evolve as a result of natural selection for that function. Some traits affect fitness through multiple functions, but they are only considered to be an adaptation for the function that they originally evolved with. One example is the structure of feathers in birds. Evidence in the fossil record indicates that the earliest feathers to evolve were not used for flying, and it is now thought that feathers may be an adaptation to survive colder temperatures, because they provide insulation. So although feathers are used for flight, and flight provides a fitness advantage in many environments, feathers are not an adaptation for flight. Traits like this whose current function differs from an ancestral function are known as exaptations.

Adaptation is a natural consequence of variation and differences in fitness, but it doesn't yield perfection. Phenotypic evolution is constrained by physical and genetic limitations. Some mutations increase fitness in one way but decrease fitness in a different way; this is an evolutionary trade-off. For example, when predators are around, Trinidadian guppies are under selection to put more energy towards reproduction, but also under selection for fast-start swimming to evade predators. Increased reproductive capacity in females makes that fast-start more difficult, so there is a direct trade-off between those traits.

Sexual selection, which is caused by preferences in mate choice, can also lead to trade-offs. For example, in widowbirds, females have a preference for males with long tails, but for the males, making a longer tail comes at a cost more energy. So why do the females care about a long tail? Why not choose a partner who is really good at acquiring resources? To the female, thats exactly what she is doing. The long tail is a signal that the male has been successful enough to have energy to spare on tail length, and will probably have successful offspring as well. In the case of Jacksons widowbird, male tail length was shown to be positively correlated to body condition, so this is considered an honest signal of fitness.

Another important note on adaptation. Phenotypes are not created as a result of a specific need, but they can evolve as a result of that need. Random mutations create new phenotypes. A phenotype will persist in the population if it has no effect on fitness and remains in existence by random chance. A phenotype will increase in frequency in a population if it increases the number of offspring that individuals contribute to the next generation.

This distinction between evolution and creation is especially important in the context of the origin of life. Evolution does not attempt to explain the origin of life. It explains how life has changed after it originated. It also explains the origin of new species, most famously described by Darwin in On the Origin of Species. It is generally accepted among evolutionary biologists that all species on Earth have a common ancestor, the original organism, the Last Universal Common Ancestor (LUCA). The main piece of evidence for this theory is the shared genetic code the translation of DNA into proteins. There are some very solid hypotheses out there for what that original organism was, and how life on Earth originated, but the theory of evolution is not in the business of answering those questions.

Natural selection is beautiful. It is easy to observe and model. It is one of the most widely-loved and studied processes among evolutionary biologists. Its no wonder that it has captured the imagination of the public we value meaning over randomness, order over chaos. A basic understanding of natural selection gives us optimism that the world is improving, leading to a better future. But natural selection is so appealing that we forget two important facts: that natural selection is just one of many mechanisms leading to physical and behavioral traits, and natural selection only occurs when there is variation in fitness, and humans are intelligent enough to be aware of and influence that variation.

A male widowbird

Via Wikimedia

There are a lot of possible explanations for why my new baby friend may resemble her father more than her mother although as she grows and changes, the consensus is that she looks like both of her parents. If there were data to support the idea that most babies resemble their father (which there are not) then the realm of possibilities gets a little more interesting, and we begin to speculate. The idea that this resemblance is an adaptation to induce men to care for their own children (and the implication that otherwise they would abandon them) fits very nicely into the gender roles that many human societies perpetuate. Armchair evolutionary psychologists love to reinforce gender stereotypes, touting that men are built for fighting and hunting and not caregiving, or women are less promiscuous and more inclined to prefer monogamy than men.

Confirmation bias kicks in: people who want these statements to be true will believe them to be true without looking for good evidence. And of course, this danger goes beyond gender stereotypes to racial and ethnic stereotypes. Our concept of race has roots in biased, poorly done studies that were held up to justify slavery in the 19th century. Notions about biological races persisted into the 20th century, when racist interpretations of the theory of natural selection led to eugenics movements around the world, including the Holocaust. The misuse of evolutionary concepts in social situations has allowed white supremacy to maintain its hold on American society, despite the fact that there is no valid scientific evidence for human races. Unfortunately, understanding that there is no biological basis for race does not eliminate racism or its real impact on human health and wellness. Systemic racism and racial trauma have devastating consequences, particularly for Black Americans.

I believe that fitness the ability to survive and reproduce is a basic human right. The existence of natural selection in nature does not justify its application to social policy. The synergy of intelligence, compassion, and social structure in humans has created a unique opportunity to prioritize equity and even the fitness playing field within our species. Some of our greatest achievements as a species have increased access to resources and raised each others capacity to survive and reproduce. These innovations are cultural adaptations rather than genetic adaptations they are passed down through culture rather than DNA. But unfortunately, in the US these innovations are more accessible to people with money, and money has become a proxy for fitness. Survival of the richest.

Humans are unique from other species in our ability to shape our environment to increase our fitness rather than waiting for our bodies to adapt. We are empathetic, we are compassionate, but we are also selfish and cruel. What do you value more: your own fitness, or your humanity?

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Evolution doesn't work the way you think it does - Massive Science

This Plant May Have Evolved to Escape Humans – Modern Farmer

One of our favorite categories of research is ways in which plants are smarteror more adaptablethan you might expect.

New research from the University of Exeter examines the case of Fritillaria delavayi, an alpine member of the lily family. This plant is used in some branches of Chinese medicine. But its increasingly hard to find, and the research indicates that might be an adaptation to its popularity.

Many related Fritillaria plants are used in Chinese medicine; the bulb, after being cooked, dried, and usually powdered, is used to treat lung conditions. The plant is not particularly common in the wild, but grows well in dry, cold, alpine conditions. Its often gathered in the Hengduan Mountains, which connect to the Himalayan Plateau, and can theoretically be found thanks to its attractive, yellow-gold flowers.

But this research, done in a collaboration between the University of Exeter and the Kunming Institute of Botany, indicates that it might be harder to find now than in the recent past. The researchers compared the rate of harvesting in different areas with how camouflaged the flowers of this Fritillaria species are.

They found that in places where people routinely forage for and harvest the plants, those plants were significantly more camouflaged with their environment, and thus harder to find, than in areas where human foraging is not as popular. This is a correlation, but the implication is that these plants have actually evolved to be better hidden from humans.

Camouflage among plants is a tricky thing; many plants show bright colors to encourage reproduction. Fruits are brightly colored to attract animals to eat them and spread their seeds; flowers are brightly colored to advertise to pollinators. But there are also examples of crypsiscamouflagein some plants, which look like stones, as if theyre actually dead, or as if theyre toxic, to avoid being eaten.

Fritillaria does have natural predators; grazing animals will sometimes eat the bulbs, and there are typical problems with beetles and some other insects. But human harvesting is a much greater threat, as it can be systematic and precise. The concept of a plant evolving to avoid human detection is one, say the researchers, that hasnt really been examined. It also hasnt been proven in this case, though the correlation makes it seem likely. In any case, its fascinating: this bulb simply wants to get away from us.

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This Plant May Have Evolved to Escape Humans - Modern Farmer

Endangered Vancouver Island marmots are making a comeback – National Observer

Vancouver Island marmots may just be the antidote required for the dystopian times we are living in.

If you must be trapped inside during this current winter of discontent, alone at a desk, scrolling through hours of video best it be watching one of the most endearing animals on the planet.

Researchers looking to conserve Canadas most endangered mammal take advantage of the creatures seven-month hibernation season to mine footage and field data for more insights that will help the animals survive, said Adam Taylor, executive director of the Vancouver Island Marmot Recovery Foundation.

The process does not get old over time, Taylor said.

After years of study, he still gets a kick out of watching the highly social, fuzzy, chocolate brown critters laze on rocks, munch the alpine vegetation or alternately tussle or boop noses with one another.

They are entertaining to watch. And there's no doubt about it, they are unbearably cute, said Taylor.

The biologist describes the marmots as a good gateway animal to hook people into caring generally about the conservation of species at risk.

They are really good ambassadors, Taylor said of this cat-sized member of the squirrel family.

I hope somebody discovers the Vancouver Island marmot and then finds this world of other endangered species that also need our help.

But for all their cuteness, the Vancouver Island marmot is a role model in resiliency, Taylor added.

Despite enduring a harsh climate, challenging conditions and changing habitat due the impacts of human activity, the marmots represent a potential good news story that illustrates the possibility of bringing a species back from the brink of extinction.

The critically endangered species has gone from a low count of just 30 wild marmots living in handful of locations in 2003 to approximately 200 living in colonies across 20 Vancouver Island mountains by 2019.

Through a captive breeding and release program in conjunction with the Toronto and Calgary zoos, habitat restoration and monitoring activities, the foundation and its partners have seen the Vancouver Island marmot repopulate areas where it was completely extirpated, Taylor said.

The last two years have resulted in a combined population of more than 100 pups born in the wild, he said.

So to that extent, yes, weve had success, Taylor said.

I think there's reason for real optimism, that we have some science and some modelling that is demonstrating that we have an approach that can bring this species back.

But he was very cautious about labelling the recovery effort as a definitive triumph of any sort.

But are we done? No, no, we're not done, Taylor said.

And if we walked away today, the species would absolutely fly back into extinction very quickly.

The Vancouver Island marmot population is still growing slowly and is extremely vulnerable to damaging bouts of predation from wolves and cougars that can more easily access colonies along the logging roads puncturing high alpine forests.

And the ever-present danger of starvation during or following hibernation is being exacerbated by climate change as the snowpack drops and spring melts quicken, limiting the supply of vegetation the marmots rely on, he said.

As well, a colonys ability to rebound after any significant population loss can be hindered if the animals travel routes to each others' communities are severed or disrupted by industrial activity or projects, Taylor said.

The foundation must still assist the marmots to boost their recovery, he noted.

Just before and following hibernation, the foundation provides the marmots which can lose one-third of their weight during their winter snooze with supplemental vegetation biscuits to fatten them up and improve reproduction rates.

Plus, the captive-bred marmots are subject to a halfway house approach when being released into the wild.

The marmots appear to have a better survival rate when they are released on Mount Washington and its attendant ski runs for their first year in nature before being recaptured and released into more challenging environments in areas such as Strathcona Park, Taylor said.

The practice seems to condition them to a natural environment and has boosted their survival rates five-fold, he said.

It does seem counterintuitive that such a highly modified habitat would benefit the marmot, especially given the negative impacts human activity has posed in the past, Taylor agreed.

But the ski hills operators avoid activities that might endanger the marmots, prevent tree growth on the runs, which mimic the avalanche slopes favoured by the critter, and the constant presence of humans deters predators, he said.

Hindsight is 20/20. But if you look at a ski hill, it looks exactly like marmot habitat, Taylor said.

And at the absolute lowest point, when we had fewer than 30 Vancouver Island marmots left in the wild, 10 of them were living at that ski resort.

The recovery effort eats up a good chunk of money and time, Taylor said.

But Canadians should feel a responsibility to protect it, he said.

We have a moral obligation, Taylor said, adding the Vancouver Island marmot is one of only five endemic species to Canada and the only one at risk.

But asking how the world would be different if we lost the Vancouver Island marmot is in some ways the wrong question, he said, noting it nearly happened once before without many people being aware of the fact.

However, saving the Vancouver Island marmot is also critical for reasons outside their own survival, Taylor stressed.

The world is facing massive declines in biodiversity and a growing list of species bordering extinction, he said.

The marmot can offer a portion of hope in this doomsday scenario, Taylor said.

We need success stories in the conservation world. This is not an easy time to work with wildlife, he said.

We need to be able to demonstrate that it's possible to bring these species back because that's the task that we're going to be engaged in more and more often. And if we don't have success stories, then it's going to be really hard for us to justify why we want to save any one of these species.

Rochelle Baker / Local Journalism Initiative / Canada's National Observer

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Endangered Vancouver Island marmots are making a comeback - National Observer

What Do Inequalities, Covid-19, and International Human Rights Have to Do With Each Other? – Inequality.org

In order to weigh the costs and benefits of protecting and promoting human rights, we must be concrete and articulate. This is evident when we study the impact of health policies on human rights beyond life and physical health. In the face of the medical paradigm which favors the biological aspects and survival of people as a legitimate discourse that influences regulations, practice models, and social representations, another more holistic one emerges. To what extent is it legitimate to forsake freedoms on the altar of a strictly sanitarist vision? International human rights law provides precise guidelines for answering this fundamental question, and this is one of the central points addressed in the new bookCovid-19 and human rights: The pandemic of inequality.

The large economic slowdown, which has exacerbated the economic challenges that several countries in Latin America were already facing in February 2020, has led to an increase in poverty and a decline in economic and social rights. In this context, only elites are capable of resilience in the face of sudden macroeconomic changes. Again we see that, beyond the urgent actions that should be taken to serve the population most affected by the crisis, a transformative agenda needs to be on the discussion table.

Human rights have a scientific, legal, and political purpose. They can shed light on the intricate economic, financial, social, and legal processes that perpetuate inequalities. It is true that the effectiveness of human rights is limited. The levels of poverty and inequalities that exist in the world, and the presidents who suggest taking toxic substances to combat Covid-19 or who recommend not using face masks, without entailing any legal consequences, give us an indication of the impact of human rights in the real world. But this should not lead us to abandon the cause of human rights, but precisely to strengthen its system of protection which, to a large extent, requires reforming the foundations of the prevailing economic system. To this end, it is essential to investigate, report, and denounce the relationships between the pandemic, inequalities, and human rights.

This article first appeared on OpenGlobalRights in English and Spanish on November 6, 2020.

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What Do Inequalities, Covid-19, and International Human Rights Have to Do With Each Other? - Inequality.org

US election 2020: The importance of sexual and …

Nadine Dirks is an intersectional feminist, writer, and advocate for sexual reproductive health and rights (SRHR). In this opinion piece, she shares her views on unsafe abortions as a public health issue.

Researchers have referred to unsafe abortions as a preventable pandemic one that affects the health and lives of women, transgender people, and non-binary individuals alike.

It is a global health and human rights issue that is not treated with the seriousness that it deserves. Through a reproductive justice lens, there are many intersecting issues that have caused this pandemic.

One of the reasons that people seek unsafe abortions to begin with is the stigma associated with family planning. We see this stigma and discrimination playing out in federal government cuts and pledges to defund organizations such as Planned Parenthood, which works to ensure womens health and right to autonomy.

When world leaders stigmatize organizations that allow for equal access to family planning, citizens cannot expect to see positive changes in societal attitudes and behavior.

Even where contraceptive services do exist, women may not be able to access them safely and avoid pregnancy. For example, they may be faced with pro-life protesters lobbying outside organizations, hurling insults and referring to people as baby killers for providing or accessing the healthcare that they know is right for them be it condoms, contraception, or a safe abortion.

If you would like to check your registration status or register to vote, we have added some useful links at the bottom of this article.

Alongside abortions, organizations such as Planned Parenthood also provide many other services. These include:

By defunding organizations such as Planned Parenthood, we have to face the fact that we are putting members of our community at risk of health complications, and that extends beyond allowing women to choose and access the services they need.

Abortions remain one of the most stigmatized medical procedures worldwide yet according to the Guttmacher Institute, nearly 1 in 4 women in the United States will have an abortion by age 45.

Statistics also indicate higher rates of abortion among Black women and Hispanic women. Why is that? It is likely due to a lack of adequate contraceptive care given to women of color and a lack of disposable income to fork out on contraceptive methods, compared with white women.

Also, due to discrimination and racism in the medical field, healthcare professionals often overlook and ignore the medical needs of women of color sometimes going as far as assuming that Black people have higher pain thresholds than white people.

Abortion and access to other contraception methods is a political, human rights, and reproductive justice issue, underpinned by a lack of comprehensive sexual education in schools.

A report from the Centers for Disease Control and Prevention (CDC), for instance, found that in most states, fewer than half of high schools and just 1 in 5 middle schools teach all the essential sex education topics recommended by the CDC.

So, with only 4% of the recommended topics being taught in Arizona, for example, it is not surprising that people are wildly uninformed and lack the necessary tools and education to even ask for what they need in terms of contraception.

And even if a person knows that they want contraception, how are they expected to assert themselves and speak from a place of autonomy when their sexual and reproductive health education has either been stigmatized or avoided altogether? People can hardly be expected to access different methods of contraception safely if they are not first made aware of which options are available to them.

This lack of education and conservative outlook on sexual education furthers the culture of stigma. In such a culture, reports have shown that people feel that they cannot have conversations or ask questions because they fear being ostracized by their communities, either on religious or conservative grounds or due to prejudice, patriarchal views, or a lack of education on matters of sexual health.

As some researchers point out, Abortion stigma is usually considered a concealable stigma: It is unknown to others unless disclosed, and it is characterized by secrecy.

Furthermore, studies show that community members disapprove of abortion and that a womans age or marital status could exacerbate judgment, with younger or unmarried women bearing the brunt of these attitudes.

Sadly, a lack of information does not reduce the incidence of unprotected sex or rates of abortion. It does, however, mean that the abortions that people are accessing are more likely to be unsafe or unregulated.

An ample body of existing data suggests that, on a global level, restrictive abortion laws and a lack of education about contraceptive methods are associated with a higher rate of unsafe abortions.

For instance, physicians from Brigham and Womens Hospital in Boston, MA, warn that in the absence of education about contraception and the availability of legal and safe abortion, desperate women, facing the financial burdens and social stigma of unintended pregnancy and believing they have no other option, will continue to risk their lives by undergoing unsafe abortions.

Furthermore, a lack of education could mean that people miss key details in spotting an unsafe abortion versus a safe one. Some may even intentionally lean toward unsafe options because it may seem more concealed than going to a clinic during the day in the middle of the city center.

Unsafe abortions come with many potential health hazards, including infections, infertility, hemorrhages, and even death. They are also often performed in facilities that are not adequately equipped, or the procedure may be carried out by someone who lacks the necessary skillset. The tools or methods they use may also be outdated, unhygienic, or traumatic. Another concern is that these unsafe procedures may also be unnecessarily invasive due to the provider not being trained to safely administer healthcare.

Specifically, the World Health Organization (WHO) list uterine perforation (caused when the uterus is pierced by a sharp object) and damage to the genital tract and internal organs as some of the well-documented complications of unsafe abortions.

Issues of reproductive justice have deep, complex roots. On the surface, it may seem as though we have rights and are free to make our own choices, but many of us are still unable to access services due to our gender, race, sexual identity, or class. What good is a Constitution if some people can access services while others cannot?

Seemingly, in recent years, womens SRHR have become even more controversial in the U.S.

In an attempt to control a persons right to choose an abortion, limitations have been implemented that restrict the allocation of other federal and state funds, such as funds for STI testing and treatment and sex education in 12 states, according to the Guttmacher Institute. This causes further issues in addition to unintended pregnancies, limiting peoples access to STI testing and treatments.

With the looming possibility of Roe v. Wade being overturned, cis women, transwomen, and nonbinary folk alike are left fighting once again for the autonomy of their own bodies.

Attempting to control what people do with their bodies entirely erases the SRHR and reproductive justice work being done worldwide. It undermines not only human rights but also the 21 million American women who are likely in need of publicly supported contraceptive services and supplies, according to the Guttmacher Institute.

These intersecting issues of education, stigma, discrimination, healthcare, and reproductive justice are all at play in the upcoming U.S. election. With SRHR being under threat, it is now more important than ever for people in the U.S. to play their part in supporting human rights by casting their vote.

To check your voter registration status, click here to visit the website of VoteAmerica, a nonprofit, nonpartisan organization dedicated to increasing voter turnout. They can also help you register to vote, vote by mail, request an absentee ballot, or find your polling place.

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US election 2020: The importance of sexual and ...

The Nation: The Many Abuses at the Irwin County Detention Center in Georgia – Government Accountability Project

This place is hell. My experience was darkness, dirtiness, muddiness. The floorsdirty. The wallsdirty. Everything was dirty.

In 2019, Jaromy Floriano Navarro was sent to the Irwin County Detention Center in Georgia, where she was held for nearly a year before being deported to Mexico in September. While at Irwin, she had a distressing experience with a medical provider who treated detainees at the facility. I met [gynecologist] Dr. [Mahendra] Amin in March. He said I had a cyst. He told me about the process to get my cyst removed. I was going to have three little dots on my belly, and it would take 20 minutes. One hole by my belly, one by my womb, one by my vagina, she said. The nurse who was taking me to the hospital told me that I was going to have my womb removed. I was like, What? No, thats not right. I am going to have my cyst removed.

Upon arriving at the hospital for the procedure, Floriano Navarro learned that she was positive for Covid-19 antibodies and her procedure would be delayed. When she returned to Irwin, she said, she was put in isolation. A few days later, she was told that she could now have her surgery. She said, I refused, and this made them mad. They were so mad. [They said,] You stay here. You get the surgery. Weve already paid for it.

Floriano Navarro began talking to other women housed at Irwin and learned that others had had similar experiences. Then on September 14 of this year, whistleblower Dawn Wooten went public with the claim that Amin had been performing an unusually large number of hysterectomies on women held at the center. You could quote me as the one that got away, Floriano Navarro said. Wooten, who was a licensed practical nurse at the facility, reported that several detained women told her they were given hysterectomies and did not understand why. In a complaint, she alleged that once the information about this practice spread, many detainees became wary of seeing doctors at the facility at all and other staffers began to wonder how widespread the practice was. Weve questioned among ourselves like goodness hes taking everybodys stuff out. Thats his specialty, hes the uterus collector, Wooten said in her complaint. I know thats uglyis he collecting these things or something. Everybody he sees, hes taking all their uteruses out or hes taken their tubes out.

The complaint, filed with the Office of the Inspector General of the Department of Homeland Security (DHS) by human rights groups, including Project South, quoted an Irwin detainee who had spoken with other detained immigrants who had received hysterectomies, saying that they reacted confused when explaining why they had one done. The woman told Project South that it was as though they were trying to tell themselves its going to be OK. She added, When I met all these women who had had surgeries, I thought this was like an experimental concentration camp. It was like theyre experimenting with our bodies.

Since the complaint went public, multiple women have come forward with accounts of similar experiences at Irwin. One former detainee, Pauline Binam,said she had her fallopian tubes removed without her consent. Mileidy Cardentey Fernandez toldTheGuardianthat she was told she would undergo an operation to treat ovarian cysts but she remained unsure of what procedure she actually underwent. Most recently, theLos Angeles Timesreportedon the accounts of 19 mostly Black and Latinx women who underwent or were pressured to undergo overly aggressive or medically unnecessary surgeries without their consent while detained at Irwin, according to a report by nine board-certified ob-gyns and two nursing experts who reviewed thousands of pages of those womens medical records. Wendy Dowe, speaking to theLos Angeles Times, said she told Amin, Ive got the right to know whats going on with me. After surgery, she was surprised to see bandages on her stomach. She wrote to his medical office, asking, What type of surgery did I have?

Amin has seen at least 60 women detained at Irwin,according to a lawyer investigating the alleged wrongdoing, and is now under investigation by the DHSs inspector general. But the problems at Irwin are hardly limited to the alleged sterilizations. The women interviewed by Project South reported horrifying conditions at the detention center as well as widespread medical neglect. In the interviews, we found evidence of sexual abuse, inadequate medical care, lack of prenatal care for pregnant women, a lack of clean drinking water, and rampant use of solitary confinement at the facility, said Azadeh Shahshahani, Project Souths legal and advocacy director. Detained immigrants who have spoken out about the conditions have faced retaliation. A Southern Poverty Law Center report noted that an Irwin detainee was placed in solitary confinement for three days for helping another complete a grievance form.

Wooten and several of the immigrants also claimed that the facility failed to follow best practices to prevent the spread of the coronavirus. In the complaint, Wooten stated that Dr. Howard McMahan, the medical director at Irwin, pleaded with warden David Paulk in March to halt all transfers of individuals in and out the facility after it recorded its first Covid-19 case. Yet McMahans pleas went unheeded: People with Covid have been entering the facility, which has also transferred immigrants out who were Covid-positive or had been tested but had not yet received their results. Wooten and various people detained at Irwin have reported that entire dorm units are placed under quarantine for 14 days after one individual is suspected of having or is confirmed to have Covid. The staffers mix new transfers with people who are under quarantine, resulting in greater vulnerability and risk. Representative Raul Ruiz, a California Democrat and an emergency physician,toured the center with other legislatorsafter the allegations became public and said he saw, among other horrors, black mold in the shower stalls, which can cause or exacerbate serious pulmonary diseases.

The Irwin County Detention Center is run by LaSalle Corrections, a private corporation contracted by Immigration and Customs Enforcement. LaSalle operates seven immigration detention facilities in four states; Irwin, whichhouses about 800 people, has long been known for its unsafe conditions. In 2017,ICEs own review of the centerfound that certain areas were unsanitary and that floors and patient examination tables were dirty. LaSalle receives $60 a day from the federal government for each immigrant it houses, a sum intended to cover food, shelter, and medical care, according toa report by the Southern Poverty Law Center.

In response to the recent revelations, Project South and other local groupsincluding Georgia Detention Watch, the Georgia Latino Alliance for Human Rights, and the South Georgia Immigrant Support Networkare gathering signatures fora petition to close the facilityand to seek redress for those harmed inside it. Meanwhile, the US House of Representatives haspassed a resolution condemning the medical abuseand calling on the DHS to pause the deportation of people who experienced any medical procedures at Irwin and to hold the individuals involved in the procedures accountable.

The United States has a long history of reproductive violence against people who have been incarcerated or institutionalized or are otherwise seen as unfit to have children. In 1899, Harry C. Sharp, a physician at the Indiana Reformatory in Jeffersonvillepioneered a program to sterilize incarcerated men. At that point in Indianas history, a number of social upheavalsincluding industrialization, urbanization, and a fear that people of color and poor white Kentuckians were encroaching on homogeneous communitiesworried the states middle and upper classes. His solution was to sterilize those considered dangerous, particularly those with a mental or physical illness. In 1907, Indiana passed the countrys first sterilization law, intended to prevent [the] procreation of confirmed criminals, idiots, imbeciles, and rapists. Though the law was struck down as unconstitutional in 1921, the state government estimated that approximately 2,500 people were sterilized through 1974, before the practice ended.

These sterilizations of incarcerated people were only the beginning of many similar efforts to sterilize members of other groups, including people of color and people with disabilities, as a public health intervention. From 1919 to 1952, Californiasterilized approximately 20,000 institutionalized peoplebecause they were deemed unfit or defective. From 1929 to 1974, at least 7,500 people were sterilized in North Carolina,most of them without their consent, because the state Eugenics Board claimed they were unfit to reproduce. Many of them were poor Black or Indigenous women, though records show that children as young as 10 were sterilized. Nor are these abuses confined to decades past. In 2013,Revealreported that from 2006 to 2010, at least 148 inmates in two California prisons were sterilized without proper state approvals or oversight, and there may be 100 more such incidents dating back to the late 1990s.

Knowing this long history of state-sanctioned eugenics policies is the first step in understanding the significance of the allegations by Wooten and the women detained at Irwin. As Dorothy Roberts, a professor of law and sociology at the University of Pennsylvania, explains in her seminal textKilling the Black Body: Race, Reproduction, and the Meaning of Liberty,the idea of population control as a social good is part of the fabric of US public health policy. Roberts argues that the American project of eugenics is rooted in the enslavement of African people and the complete denial of reproductive control. For Amari Sutton, an organizer with Project South, the abuses alleged at Irwin must be understood as the result of fascist state control and abuse of Black and brown bodies [and] the historical capitalist interest in incarceration and detainment that mirrors chattel slavery.

Representatives Rashida Tlaib, Alexandria Ocasio-Cortez, Ayanna Pressley, and Ilhan Omarare calling on international agencies to conduct investigations. Holding the Department of Homeland Security accountable for its long history of abuses is a human rights, reproductive justice, and public health imperativeone that has been put on the backburner at the expense and detriment of our immigrant neighbors, Tlaib said in a statement.

Like prisons, immigration detention centers are often isolated spaces, hard to reach and to monitor by design. These activists and detainees are taking great risks to expose what they know. Speaking toThe Nationfrom Mexico in October, Floriano Navarro was distraught. I wish I was back home in South Carolina with my daughters, she said. Its like I cant breathe. The mental abuse and the depression I go through is so hard. When Im alone and I drift into my thoughts, I think about how it felt to be there. I want you to write about the depression. Its so hard.

She added, When you are inside there, its like you have no control of your life, its like they can do whatever they want to you.

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The Nation: The Many Abuses at the Irwin County Detention Center in Georgia - Government Accountability Project

A new window on the meetings of the ancient skull, human migration, Denisovan – Sprout Wired

Make it bigger / These excavations identified the Denisovan DNA inside the wire.

Dongju Zhang, Dongju Zhang, Lanzhou University

The Denisovans hold a very strange place in the history of humanity. Like the Neanderthals, it is an early branch of the genealogy that produced modern humans and later merged with modern humans. But weve known Neanderthals for about 150 years, before weve traced their DNA sequence and identified the group of their physical characteristics from which they were defined. On the contrary, we had no idea that Denisovans existed until their DNA suddenly changed into a small piece of a finger. And, to this day, we havent identified enough leftovers to say anything about what they really look like.

However, over time, we have grown older DNA samples that provide a clearer picture of our interactions with this mystical lineage. Now, two new reports detail ancient DNA that provide some more details. One paper describes a modern human genome in Asia that is close to the time when interbreeding is essential. This provides further evidence that there were at least two instances of reproduction and helps to explain how the human population moves around Asia. The second confirms that the Denisovans lived along the Tibetan plateau and may have moved to higher altitudes.

In 2006, excavations in Mongolias Salkhit Valley led to the top of a skull that was apparently old. However, since there were no definite features, people debated whether it could be a dormitory or not. Standing man. However, early DNA sequencing indicated that it belonged to a modern human, with carbon dating to be about 34,000 years old.

This is indeed a critical period in the history of humanity. At this time, the East Asian and East Eurasian (or Siberian) populations were different, later it belonged to some West Eurasians. Their histories are very complex. A 40,000-year-old skeleton near Beijing is clearly the closest to modern East Asians but the closest is to a skeleton in Belgium (! ?? !!). A 45,000-year-old Siberian skeleton does not seem to have any modern relatives, while a 24,000-year-old man from the same region identified the population that was found to be born in East Asians. Native American ancestry. But two other Siberian skeletons at about the same time do not represent that love and only appear to be Eurasian in general.

If you are not confused after that, go back and read it again.

Given this disturbance, no other DNA of that period and area could be useful. Therefore, researchers have done what has become a standard method for preserving this old DNA. They first looked for sequences that matched human DNA to cut out human scenes. To eliminate contamination from modern humans, they again looked for signs of the most common damage in the form of the DNA age. Anything that was obviously human and damaged was used to add a genome.

The end result is that you get the top of the skull according to the age you expect. Most of the differences in DNA are similar to modern humans, but there were many areas that were similar to Neanderthals and Denisovans. The modern human fraction is the closest match between the Eastern Eurasian and Native American populations, confirming past results.

But its still almost as confusing as ever. The [newly described] The literate person shares many lambs with Tianyuan [Beijing] Individuals with 31,000,000-year-old Yana people in northeastern Siberia, the researchers write, yet Tianyuan and Yana people share fewer alleles with each other than the written person. Overall, the researchers conclude that after some time the West and East Eurasian populations diverged, with some inter-productivity between East Eurasians and East Asians.

But of course, the newly described Siberian DNA has a unique resemblance to the Belgian skeleton, suggesting that at least some Western Eurasian DNA was still being passed down through the lineage.

As far as Neanderthals are concerned, the new Siberian skeleton is quite unique to the modern Asian population, with about 1.7 percent of its DNA coming from Neanderthals. Denisovans content is difficult to judge, but researchers found 18 large pieces of DNA that were inherited from Denisovan. The size of these researchers concluded that interbreeding took place about 10,000 years ago. This is consistent with the complete absence of Denisovan DNA in the 45,000 year old Siberian skeleton. And the existing Denisovan DNA is more compatible with the amount seen later in East Asian cages.

Interestingly, the segments present in the newly written genome do not overlap with those found in the genomes of modern humans in Southeast Asia and the Pacific. The obvious implication is that modern man coincides with the Denisovans on at least two different occasions. This is something that was shown by other results, but modern East Asians have DNA from both of these events. The written genome provides a distinct distinction between them.

Meanwhile, a separate paper looks at where the Denisovans lived especially in the Baishia Karst Cave on the edge of the Tibetan Plateau. At 3,000 meters (about 11,000 feet) above sea level, it was a very high altitude environment that would have been difficult to build during the last ice age. Yet there was found a part of a jaw bone. Although it did not take any DNA, the protein fragments indicated to the jaw that it belonged to a Denisovan.

Most older DNA samples are severely damaged by bacteria, with severely damaged and broken DNA. As a result, researchers have developed different processes to help differentiate human-like DNA and then identify older DNA based on the pattern of its accumulated damage. Gradually, it was realized that the same techniques could work where the contamination was higher and the human order even lower: soil samples. So, while we couldnt extract the DNA from the jawbone, one team decided that there was something left in the environment from which it came.

So, the team tied rocks at the bottom of the cave, dating the different layers, to create an approximate historical sequence. Most layers contain mammalian DNA that is quite old in terms of damage. Therefore, researchers extracted human mitochondrial DNA and began to sequence it. This was obviously Denisovan, with a slight possibility of a small fraction of modern human DNA.

In all, the signs of Denisovans occupation date from about 100,000 years ago to about 30,000 years ago. This is a detailed history of the profession, although we do not know if it was continuous, seasonal or seasonal. Although 70,000 years is definitely a long time, researchers have called for higher altitudes. And it turned out to be in line with another genetic research: that some Tibetan genetic adaptations were at higher altitudes. Inherited from the Denisovans.

Science, 2020. DOI: 10.1126 / Science.ABC1166, 10.1126 / Science.BB6320 (About DOIs).

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A new window on the meetings of the ancient skull, human migration, Denisovan - Sprout Wired

Structural basis of trehalose recycling by the ABC transporter LpqY-SugABC – Science Advances

In bacteria, adenosine 5-triphosphate (ATP)binding cassette (ABC) importers are essential for the uptake of nutrients including the nonreducing disaccharide trehalose, a metabolite that is crucial for the survival and virulence of several human pathogens including Mycobacterium tuberculosis. SugABC is an ABC transporter that translocates trehalose from the periplasmic lipoprotein LpqY into the cytoplasm of mycobacteria. Here, we report four high-resolution cryoelectron microscopy structures of the mycobacterial LpqY-SugABC complex to reveal how it binds and passes trehalose through the membrane to the cytoplasm. A unique feature observed in this system is the initial mode of capture of the trehalose at the LpqY interface. Uptake is achieved by a pivotal rotation of LpqY relative to SugABC, moving from an open and accessible conformation to a clamped conformation upon trehalose binding. These findings enrich our understanding as to how ABC transporters facilitate substrate transport across the membrane in Gram-positive bacteria.

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Structural basis of trehalose recycling by the ABC transporter LpqY-SugABC - Science Advances

Oh Faith: Fertility, civil unions and religion | Perspective – Rutland Herald

Sorry, but I have to bring up Pope Francis again. He was very much in the news last week when he was shown in a new documentary, Francesco, saying: Homosexual people have a right to be in a family. They are children of God and have a right to a family. Nobody should be thrown out or made miserable over it. What we have to create is a civil union law. That way they are legally covered.

In a way, this is old news, since anyone who knows the record of Francis as a bishop in Argentina knows he has said similar things in the past. But now that he is pope, it is big news. Some people are elated; some people are infuriated either because he has gone too far or not far enough. The not far enough is that he didnt call for gay marriage but rather, civil unions.

Why would he do that? Is it because he is just an old dried-up stick-in-the-mud, mouthing opinions that are 100 years out of date? Im sure many people feel that way. He certainly did not say it because he hates homosexuals. That is clear from any number of things he has said over many years.

There is a complicated, but important, reason behind his position; it is related to what is called Catholic Social Teaching and the Catholic definition of the word marriage. At its most basic level, the church holds that a marriage (Holy Matrimony) must not only be between a man and a woman, but -and here is the crux of the matter they must also be ready and willing to have offspring and to raise them within the church. If you are not willing to state your intentions to do both those things, you cant be married in a Catholic Church because the church holds that marriage is inherently, sine qua non, related to the creating and rearing of the next generation.

At this point, Im going to leave off being any sort of apologist for the Catholic Church. Im not good at it, and the point here is larger than a church issue.

Our more formal word, and the longstanding legal term, for marriage even to this day is matrimony, which comes from the Latin mater (mother) and monium (state or condition). Our language, as is usually the case, carries within it the ultimate origins of things. Matrimony is a state that, at its root, is related to an offspring or multiple offspring and their mother. Matrimony exists to further the protection of mothers and their children, because they are absolutely essential to the continuation of society. Hence, when matrimony fails, our legal system establishes alimony and child support.

The condition of matrimony, across time and space around the entire world, has been closely related to the propagation of the human race. There is more than a little logic to the idea that the state of matrimony, to be linguistically and biologically accurate, can only apply to a female and a male union because that union, and only that union, naturally creates children. It is called sexual reproduction, which is the only way all higher life forms reproduce themselves.

Reproducing themselves, lets talk about that.

We in Vermont are very bad at it. We have almost the lowest fertility rate in the United States and the states population is steadily declining. All of the United States is now at a total fertility rate below replacement level, which is 2.1 births per woman. The U.S. fertility rate is 1.8 (the European Union is 1.5). The only reason the U.S. population is staying stable is immigration.

When I was still teaching at college, I found almost all my students thought living in a country with a declining population would be just fine, because there are already too many people on the Earth. I also found they had not thought through what it really means to live in a place that has fewer and fewer people each year. It is not pretty and not fun and does not have a lot of job opportunities.

I have been to rural France, and I have seen whole villages that are now ghost towns. I have traveled around Italy and visited towns where you almost never see a child because almost none live there. It is more than a little depressing. More serious than depressing, however, is the issue of essential social services. How can a country cover the costs of its aging population when there are fewer and fewer people entering the workforce and paying into the health care and pension systems, not to mention roads and sewers.

Its not easy to marry and have children. It is hard work. It is the hardest thing, and the most important thing, we are required to do. The only relationship that can naturally give birth to, and raise, the next generation is matrimony. Not only does it merit a special designation in our everyday speech and in our legal system, but it merits more in fact, far more incentives, protections and assistance than it currently receives in the U.S.

The Western First World has a population problem, but its not the infamous Population Bomb of Paul Ehrlich; its the opposite. Not too many people being born, but too few. Throughout the entire U.S., only one ethnic group is reproducing itself (2.1 births): Hawaiian/Pacific Islander. Thats it.

I agree 100% that gay and lesbian people have a right to be in a family as the pope has said, and Im glad he said it. It is an issue that our society is well on its way to addressing, and I am glad to see it happening. But, just as importantly (or even more so), I also agree 100% that men and women have a right, and actually an obligation, to form lasting unions to give birth and nurture children at a rate that creates sustainable communities and fosters the best welfare of children.

It is this last type of union, cisgender matrimony if you will, that is in even more need of focus. Today, in the United States and the European Union, almost 50% of births are to women who are not married. A Pew Research Center study of 130 countries in 2019 found the U.S. has the highest rate of children living in single parent households in the world. And this is in addition to the reality were not having enough births to replace ourselves. If thats not literally a dying culture, I dont know what is.

In our justified and admirable quest to address the concerns of the LGBTQ community, we must not forget to address the concerns we should have about one of the most basic rights and obligations we have as members of the human community: our biological imperative to produce and protect the next generation.

Frankly, were not doing so well at that right now.

John Nassivera is a former professor who retains affiliation with Columbia Universitys Society of Fellows in the Humanities. He lives in Vermont and part time in Mexico.

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Oh Faith: Fertility, civil unions and religion | Perspective - Rutland Herald

Angela Davis on the Struggle for Socialist Internationalism and a Real Democracy – Jacobin magazine

I question whether the outcome of the last election might have been different if more attention had been paid to those who are experiencing the impact of global capitalism the poor white families who now recognize that their children are not going to be better-off than they were. The outcome might have been different if we had developed strategies permitting us to recognize that so many of the existing problems in this country are directly related to the rise and spread of global capitalism.

As a matter of fact, we used to have more economic democracy than we do today. Once, people could expect to be treated at any hospital if they were ill. Hospitals and the whole health care system had not been privatized, as they are now, which is one of the reasons why the COVID-19 pandemic has created such a state of emergency particularly with respect to hospital beds, because empty hospital beds are not profitable.

If one looks at the impact of global capitalism, it is very much an explanation for the rise of the prison industrial complex, as well as the disestablishment of so many institutions that used to serve as an economic safety net for people. The failure to develop more institutions devoted to the public good has created a terrain in which poverty has expanded, not only among communities of color, but also among white people.

The current occupant of the White House called upon those who were suffering, providing false solutions, such as a return to an era in which the industrialized economy in this country responded to peoples needs. And thats not going to happen. The jobs that have gone all over the world, particularly to the Global South, are not going to return to the United States. It is important to consider the ways in which economic transformations have a direct impact on democracy.

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Angela Davis on the Struggle for Socialist Internationalism and a Real Democracy - Jacobin magazine

New attacks suggest that the opposition is preparing plans Illadel Graff Supply – Illadel Graff Supply

Political tensions are mounting in Venezuela, just over a month before the general election. A number of events over the past week have shown that the far-right opposition is planning new destabilizing measures.

MEP Juan Guaid and his party refused to take part in the electoral process and asked for a public consultation on December 12, six days after the election, to question whether Venezuelans would accept Nicols Maduros presidency.

The process is openly supported by the United States in the role of CEO James Story, who also argues that Guaid should mobilize the Venezuelans again.

The Venezuelan constitution has a mechanism for a revocation referendum that can be triggered by the population midway through the presidential term. In 2004 the opposition called a referendum against former President Hugo Chvez and lost. Now Guaid is demanding a lawsuit without legal provisions.

In addition to its lack of legitimacy, it is worth asking why this consultation should be called when Venezuela is in an electoral process. Not only is it supposed to create parallel institutionality, but it is also a letter of confirmation to set an agenda for street mobilization start An agenda that is supposedly popular, but is nothing more than urban terrorism, comments Ernesto Cazal, analyst at the Venezuelan portal Misin Verdad.

Other facts suggest that the Guaidosist sector may be embarking on a new coup path.

Fugue Leopoldo Lpez

On Saturday (24), the founder of the Peoples Party Voluntad Popular and Juan Guaids right-hand man, Leopoldo Lpez, fled Venezuela to Spain. The details of his trip were not disclosed, but the opponent himself says he traveled to the Caribbean island of Aruba, where he took a flight to Madrid.

Lpez had been at the Spanish embassy in Caracas since last year. On April 30, 2019 he escaped house arrest in order to attempt a coup with Guaid. With the failure of Operation Libertad, Lpez fled to the Spanish diplomatic headquarters.

Juan Guaid and Leopoldo Lpez during the attempted military coup on April 30, 2019 / week

The leader of the Voluntad Popular Party was sentenced to 13 years and 9 months in prison for guarimbas violent counteracts of 2014, when 43 people died and about 3,000 were injured.

In Madrid, together with his family and his father, Leopoldo Lpez Gil, MEP of the Peoples Party (PP), he represents a government center for Juan Guaid.

At a press conference he confirmed that he intended to return to the country and that his aim was to hold free, fair and verifiable elections. In addition to international support for the overthrow of the Maduro government.

Since 2016, Lpez and Guaids party has not participated in electoral processes to classify it as fraudulent. In 2020 there was a reform of the National Electoral Council (CNE), which was agreed with the opposing parties. However, Voluntad Popular continues to refuse to apply.

Money embezzlement program

Last Thursday (29) Roland Carreo, the vice presidents director, was arrested after a program of corruption with funds from Citgo Petroleum the headquarters of the Venezuelan state oil company PDVSA in the United States was exposed. According to the Venezuelan prosecutors office, funds for the Simon Bolivar Foundation, which supports health care for Venezuelan children, have been distributed to the four main opposition parties: Voluntad Popular, Accin Democrtica, Primero Justicia and Un Nuevo Tiempo.

As of 2019, Citgo has been led by executives appointed by Guaid as the US failed to recognize the legitimacy of Maduro and his office through the company.

Carreo was arrested with an AM15 rifle, $ 12,000 in cash and documents with secret routes to Colombia. In a recorded statement, the Vice President confirmed that Carlos Vecchio, Guaid-appointed Ambassador to the United States, was the person who approved the financial transactions.

Carreo said his party siphoned $ 34,000 in funds from his party, and he recently turned over $ 6,500 to Leopoldo Lpez. Conversations with Juan Guaid and other opposing political figures were found on his cell phone, which still prove that Carreo wanted to use this stolen money to buy luxury cars and finance a male prostitution ring.

Conversations recorded on Roland Carreos cell phone demonstrate personal use of embezzled money by the Venezuelan company Citgo. / Reproduction

Amuay refinery explosion

The day before Carreo was arrested last Wednesday (28), the Venezuelan authorities condemned the explosion of one of the towers of the Amuay refinery in Falcn state in the north of the country.

According to preliminary investigations, the oil complex one of the largest and most important in Latin America was attacked by a missile that may have been launched from a drone or ship.

One of the towers of the Amuay Refinery under repair was completely destroyed by the explosion. / Reproduction

The Vice President for Economy, Tareck El Aisami, assured that the entire region of the Paraguan peninsula could have been destroyed by the explosion if the affected tower had worked.

In September an American citizen was arrested for illegally entering the country. He was carrying CM4 explosives and confidential information through PDVSA. Matthew John Heat, who works for the US Central Intelligence Agency (CIA), was accused of planning the explosions in Amuay.

Responsibility to Protect

The recent events in Venezuela can be linked by a common element, namely the promotion of R2P Responsibility to Protect. A mechanism that the United States and its allies have called for at different times in recent history and that uses a context of chaos and destabilization to justify intervention, defends Ernesto Cazal.

During the last General Assembly of the United Nations, the self-proclaimed President Juan Guaid called in a video conference with representatives of some countries to activate the Responsibility to Protect mechanism in Venezuela and stated that the state led by President Nicols Maduro does not offer protection to Venezuelans.

In 2005 the UN member countries took on the obligation R2P Responsibility to Protect with the three pillars: 1) Responsibility of every state for the protection of its population; 2) the responsibility of the international community to help states protect their nation; 3) Responsibility of the international community to protect a population from the actions of a state

Juan Guaid and James Story, responsible for US business with Venezuela / reproduction

The mechanism comes shortly after the NATO troops march into the former Yugoslavia and provides military support for separatists from the province of Kosovo. In March 1999, the cities of Belgrade, Pristina, Novi Sad and Podgorica were bombed on the grounds that the Yugoslav state, led by Slobodan Miloevi, carried out an ethnic massacre by the Socialist Party against services that formed the majority in Kosovo. .

The action was not approved by the United Nations Security Council (UN), which set a precedent for a number of other wars started by Western nations in the years that followed.

The remainder of the military operation caused 1200 deaths from 9,160 tons of bombs, about 45 tons of uranium, with ongoing toxic consequences for the local population.

Leading NATO countries, including the United States, began to use the Responsibility to Protect narrative from this attack.

The Kosovo war, which ended in 2008 with the unilateral declaration of independence as a nation-state, served as an example for other actions.

:: See a timeline of scam attempts in Venezuela ::

Jean Bricmont devoted himself in his book Humanitarian Imperialism to the analysis of the instrumentalization of human rights to promote wars as a solution.

The Venezuelan analyst believes the demand for a public consultation on December 12th could be a new moment of tension. However, he underestimates the ability to convene mass activities and argues that something that happens is funded by the opposition.

This would be a further expression of Guaids political failure, but there could also be a citizens appeal to the population to support the consultation and produce the famous guarimbas there, analyzes Cazal.

Edition: Daniel Lamir

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New attacks suggest that the opposition is preparing plans Illadel Graff Supply - Illadel Graff Supply

Griz 399 And Cubs Pay A Harrowing Visit To The Jackson Hole Suburbs – Mountain Journal

The unexpected wandering this week of the worlds most famous grizzly bear and her four cubs deep into the suburbs of Jackson Hole, Wyoming, is riveting the attention ofconcerned fans throughout the Greater Yellowstone region and around the world via social media.

The 24-year-old mother bruin, long known as 399an identity given her decades ago by bear researchershas been perilously navigating a human-dense gauntlet in Jackson Hole known as the West Bank.The area generally encompasses the flats of the valley stretching from Teton Village southward to the tiny enclave of Wilson and lying between the Tetons to the west and east toward the Snake River.

But late Wednesday, new unconfirmed reports suggested that maybe 399 shifted her position yet again drifting back toward the north. However, it was revealed Thursday that the clan was south of the town of Jackson, on a ranch in an area known as South Park bounded on the east by busy US Highway 191 and on the west by the Snake River.

Now, a recap of what has ensued during this last full week of October.

Far from the terrain she normal frequents in and around Grand Teton National Park, 399 and her quartet of cubs born this year were spotted Tuesday along the heavily-trafficked Moose-Wilson Road dozens of miles from her usual autumn haunts.

After nightfall arrived, the five-some disappeared into darkness. But on Wednesday morning they were on the move again, this time headed further west through the outskirts of Wilson.

The exact locations of her whereabouts will not be divulged here, in part to not induce crowds to go looking for her but also because doing so is moot since the family continued to roam the equivalent of several miles each day.

Still, wildlife advocates say it is important that Jackson Hole residents and visitors passing through the southwest corner of the valley be aware of 399s presence. Motorists are being asked to slow down and drive with heightened awareness while those with homes are advised to leash any loose dogs, secure trash and any potential unnatural food attractants, to make noise when outdoors in yards with lots of foliage and carry bear spray.

Any story here would be incomplete without mentioning again how far she has come, in debunking the reputation of grizzlies crafted in an earlier less-ecologically literate age and adding new chapters to her expectation-defying life.

Born in 1996, 399 has given birth to three different sets of triplets in addition to the four that emerged with her in May of this year. In all, two dozen bears are descended from her as cubs and adult offspring that have produced their own cubs.

While that is an amazing record of grizzly reproduction, a significant number of those in her bloodline have died from various kinds of lethal encounters with people. Some have been struck by cars, another was shot by a hunter who was convicted of shooting the bear without just cause, another was killed for eating livestock and another trapped and removed because it ventured into the same suburbs where 399 went this week. That bruin was deemed a potential safety hazard to humans.

Every year, 399 has demonstrated a fairly calm temperament and become adept at moving around large groups of onlookers sometimes numbering in the hundreds along the roadsides.Her uncommon tolerance for human presence, and thus her visual accessibility, has only heightened her fame, but it also has attracted people who carelessly venture too close, putting themselvesand herin danger.

More than a decade ago, 399 mauled a hiker near Jackson Lake Lodge who accidentally stumbled upon her first set of triplet cubs as they feasted on an elk carcass.

At the time, Grand Teton Superintendent Mary Gibson Scott chose not to take action and remove 399, saying that the bear was only behaving naturally under the circumstances. Scotts decision proved to be a fateful and, in many ways, monumental one, for in the years since 399 has risen as perhapstheliving poster child for grizzlies and their recovery.

Ironic, maybe, is that while Mangelsen was out looking for grizzly 399 east of Jackson Lake last week, she showed up barely a stone's throw from his house in the Meadow subdivision. They dined ravenously on hawthorn berries with the cubs using a buck and rail fence as a perch for reaching the food as 399 pulled the branches down with her paws. Photo courtesy Thomas D. Mangelsen (mangelsen.com)

Normally, 399 and differing broods of offspring shes had over the years would now be foraging mostly on a broad sweep of public land that includes the intersection of Grand Teton Park, the Bridger-Teton National Forest in the vicinity of Pilgrim Creek and the National Elk Refuge.

Favorite destinations in the past have included rich patches of hawthorn berries along US Highway 26 and a portion of Moose-Wilson Road in Grand Teton Park where it narrows and often closes down at times to accommodate bruin feeding. With elk hunting happening in both the park and national forest, too, she also is known to feast on gut piles left behind by hunters who field dressed their wapiti and on wounded animals that died and were not recovered from the field.

However, the latter habit brings its own risks. Bear researchers in Greater Yellowstone say that some grizzlies will move toward the sound of rifle shots, having learned to associate the echoing rapports with a fresh meat meal.In addition, in contrast to how hikers are told to pass through grizzly countrymaking noise and hiking in groups of fourhunters often stalk elk and deer by bushwhacking quietly and with stealth.

Gut piles and leftover carcasses, because they give bears protein at a time when other natural foods are on the wane as the snow flies, are thought by some researchers to be important not only for 399 and cubs, as well as 399s daughter, bear 610 and cubs, but all bruins now in the physiological state known as hyperphagia. During hyperphagia, bears are on a quest to eat as much food as possible and put on fat and body mass prior to denning in a few weeks.

Whether a female bear is well nourished or not can mean the difference between a bear becoming pregnant, successfully giving birth to cubs and even surviving long winters.

While the reason for 399 heading south into unfamiliar territory with her cubs is not knownno human obviously has interviewed herboth ardent bear watchers and wildlife officials believe it probably has to do with her search for food.

Photographer Thomas Mangelsen and others believe that 399 is in pretty good shape physically for this time of year but may be more harried having to look out for an extraordinarily large litter of cubs. (Some think she looks "skinny.") In addition, observers have noticed that one cub appears to be exhibiting a slight limp in its gait That 399 has kept her cubs well fed and ordinarily healthy is considered an impressive feat.

On Tuesday evening, just as the sun was descending the ursid clan crossed Moose-Wilson and that, again, was when the near collision occurred. Days earlier, their tracks were spotted on the other side of the Snake River in a residential subdivision and not far from where Wyoming Game and Fish has placed a trap to catch a black bear that was considered a nuisance.

Local bear watcher Ann Smith, who often serves as a nexus of information on 399 and clan, noted how the matriarch had been spotted near the Jackson Hole Golf and Tennis Club along Spring Gulch Road last weekend and then showed up on the edge of the Teton Pines gated residential community on the other side of the Snake River.

So concerned harm might befall the bears, Smith wrote in an email to several dozen Jackson Hole denizens. "I cruised the Teton Village Road [Moose-Wilson] with my flashers on going 25 miles an hour in hope that people would slow down in case she crossed the road again." On Wednesday the bear was spotted variously along Fish Creek Road, then up Teton Pass and down Fall Creek Road.

For wildlife officials with Game & Fish who try to reduce human-bear conflicts, they say the fate of 399 and family could likely come down to the behavior of unsuspecting and well-meaning humans. Jackson-based game warden Jon Stephens says vigilance in being concerned for her welfare is good but it needs to be tempered.

My take is that people need to give her space and not get so infatuated with seeing her and thinking they are looking after her, that they chase her down, he told Mountain Journal Wednesday morning after 399 and crew were spotted near Wilson. Its the mob mentality that has taken hold at many of the sites wheres shes been observed and people seem to feed on it. One person might be 100 yards from her, and then the next person is 80, and people get closer and closer until they are where they shouldnt be.And that, obviously, is not exhibiting sound judgment.

Stevens reminds the public that 399 is a wild grizzly bear with cubs. During her life, she has learned to be tolerant of people but she is still protective of her offspring and needs space.The best chances for a positive outcomethat the mother bruin heads back to Grand Teton and the Bridger-Teton Forest is that people allow her to follow her natural instinct and give her a wide berth to navigate. He also said that motorists, especially in evening and early morning need to drive with caution.

Never has a family of bears inspired more people and attracted a more devoted coterie of wildlife watchers in Jackson Hole than the clan of grizzly 399. Here, this past summer, the quartet of cubs crosses the busy highway in Grand Teton National Park. Photo courtesy Sue Cedarholm

Given how fast information can travel in this digital ageinstantaneouslycitizens adhering to, and promoting responsible behavior is the best course of action for helping to insure her walkabout is a safer one, Stephens says.

Regarding the availability of gut piles and carcasses left on the landscape as a result of hunting, he noted that hunter success in the north valley so far has been par to perhaps subpar meaning the usual bounty of edibles available to bears, up to this point, has been lower.

In one way, weve been spoiled here in Jackson. Weve had unseasonably warm and dry weather. But the recent snow and cold conditions are helping to bring elk out of the mountains, he said.

For wildlife photographer Mangelsen, his own instincts suggest that 399, in the absence of the meat, has been following her nose. I think shes hungry, he said after observing 399 Wednesday afternoon feasting on hawthorn berries near Wilson before the bears disappeared into what he called a safer part of the landscape yet still in the exurbs that stretch between the Tetons and the town of Jackson.

Mangelsen noted that hes seen 399 travel more than 35 miles in a single day and that she, like other bruins, have a remarkable homing instinct based upon their superior sense of smell. In years past when shes had young cubs, 399 has headed to the den in late November or early December. The latest shes stayed out before hibernation has been just past New Years Day.

On Wednesday night, good news may have arrived, its veracity unconfirmed, when bear watchers say they might have spotted 399 and cubs more than a dozen miles from where Mangelsen had last seen her. Her new location: allegedly north of Teton Village and on the verge of re-entering Grand Teton Parka certainly less menacing place for a grizzly with cubs than threading a needle through the heart of suburbia.

IMPORTANT UPDATE to story ending above: It was confirmed Thursday that 399 and cubs werenot back up north near Grand Teton National Park. The bear clan was spotted south of the town of Jackson in the big area known as South Park. This is also a perilous place for the bears to be. Please heed the advice of Wyoming Game and Fish Game Warden Jon Stephens and give the bears their space.

See the rest here:
Griz 399 And Cubs Pay A Harrowing Visit To The Jackson Hole Suburbs - Mountain Journal

The Journey to Save a Turtle – Earth Island Journal – Earth Island Journal

Once the collected eggs have hatched, the turtles are kept and reared for about a year by Chicago-area partners of the program, which include Cosley Zoo, Brookfield Zoo, and the Shedd Aquarium. Then, they are released back into the wild. By the end of the year, Thompson predicts that the program will have hatched nearly 3,900 Blandings turtles.

Still, threats to Blandings turtles continue outside the laboratory. Female turtles migrate long distances to nest, and too many are hit by cars as they cross roads and highways. Others, especially eggs and hatchlings, are eaten by racoons, skunks, and opossums predators that have adapted easily to human landscapes, expanding their numbers as we do.

About an hours drive north of DuPage, Lake County Forest Preserves ChiwaukeeIllinois Beach Lake Plain is the largest Blandings turtle natural habitat in Illinois. Here, biologist Gary Glowacki and his team are addressing predator-related threats by setting up protective mesh cages around turtle nests and removing raccoons by trapping and euthanizing them. To allow the raccoon population to go unchecked, they would completely decimate some of the other native wildlife, Glowacki says. Our job as land managers is to try to protect that biodiversity the best we can.

In DuPage County, Thompsons captive bred turtles still face these threats as Thompson is all too aware. He once named a grouping after his mom and three sisters: Norma, Janet, Annette, and Karen. One year, [the turtles] were all together, Thompson says. He considered taking a family portrait of the four, but instead called it a day. The next year, I found the turtle named after my mom dead. And Ive lost two of my three sisters since. It really does show how hard it is out there.

But Thompson says the outlook for Blandings turtles is encouraging. In 2014, for instance, DuPage County first captured, in the wild, a turtle raised from a hatchling in the head start program, which Thompson saw as a sign of hope. We hadnt seen that turtle in eight years or so, he says. And not only that, shes an adult female and she was full of eggs.

Now, Thompson often finds recently released juvenile turtles, and even turtles pushing eight to ten years old a maturity threshold that increases the likelihood of survival and reproduction. Twenty-five years into Thompsons Blandings turtle program, he now estimates there are 250 to 400 Blandings of various age ranges in the DuPage County population, compared to the 50 or fewer adult turtles when his work first started. And data now suggests that all age populations of Blandings turtles in Lake Plain are growing.

Even with the numbers climbing, the species is still endangered in Illinois. And the upward trend isnt a sure thing. The reality is, if the head start program was abandoned now, the Blandings turtle population would dwindle to where it was before. At best, the program has helped offset the known loss of wild adult turtles by building up populations of juveniles and sub-adults.

At some point, Thompson will hand off his work to a younger generation of conservationists. Does it worry me? Yeah, he says. What if it isnt embraced and they go a different direction and things dont work well and it declines?

Even so, when Thompson traverses the familiar landscapes of his youth, he is cautiously optimistic about the future. As another season approaches, he is reminded of the quiet, magical moments of the job. In the stillness when hes wading through the marsh, sometimes hell feel a turtle brush against his leg or foot. The wildlife, again, just coming to him.

Read more here:
The Journey to Save a Turtle - Earth Island Journal - Earth Island Journal

Control of COVID-19 in a migrant-populated area in Thailand | RMHP – Dove Medical Press

Introduction

In late 2019, the world recognized Coronavirus Disease 2019 (COVID-19), a disease that is causing a rare global pandemic.13 As of 14 February 2021, more than 108 million COVID-19 cases were reported in 219 countries and the toll of infections increased at a speedy pace.4 The first wave of COVID-19 in Thailand was caused by clusters of local infections related to imported cases from other countries, local transmission in boxing stadiums, entertainment venues and other crowded public places.5 In response to this, the Thai Government introduced several measures to curb the outbreak; for instance, international travel restriction, fourteen-day quarantine for all international returnees, interprovincial travel prohibition, and social distancing.6

The Division of Epidemiology (DOE) under the Department of Disease Control (DDC) of the Ministry of Public Health (MOPH) has played a pivotal role in containing the outbreak. One of the key measures is active case finding (ACF) in communities.

However, Thailand is now facing a new challenge as the second wave of the epidemic emerged in late December 2020, and this time, the impact was more severe than the earlier wave.7 Before December 2020, the number of total cases nationwide was about 5000. The national figure skyrocketed after January 2021. As of 14 February 2021, the volume of cumulative nationwide cases amounted to 24,571, almost triple the total cases reported in 2020.8

The new wave of the epidemic was believed to originate from migrant workers in a large shrimp market in the inner city of Samut Sakhon, a vicinity province of Bangkok. The province is a home to more than 11,000 factories with approximately 400,000 migrant workers (comprising those holding legitimate work permit and those without). The majority of the workers are from Myanmar. The living conditions of these workers are quite crowded, making social distancing or using masks all the time difficult.9 A rapid survey in early January 2021 by the DOE found about one fifth of the factories had some degree of infected workers, varying from less than 5% to more than 20%. The daily incident cases in Samut Sakhon numbered about 100150 throughout January 2021.8 On certain days when the ACF was conducted, the incidence cases exceeded 800. Migrant workers accounted for approximately 80% of the total cases and most were identified by mass COVID-19 testing in migrant communities (as part of the ACF). City lockdowns and strict social distancing campaigns were also implemented.10 Although numerous measures were enforced, the case toll still seemed to grow; and, at the time of writing, there was no sign that the case had reached its acme.

Based on the interim data of many clinical trials, the COVID-19 vaccine was estimated to be effective in preventing severe-to-moderate COVID-19 clinical symptoms. The efficacy varied across vaccine companies and across trial settings (6295%), though recent evidence showed a promising sign that the vaccine might be able to prevent disease transmission.11,12 This created a contentious policy discourse and widespread public debate in Thai society about whether the COVID-19 vaccine could be a useful weapon to fight against COVID-19, especially in Samut Sakhon where the epidemic was still active and social distancing was difficult to implement due to the crowded living conditions of migrant workers.

At the time of writing (January 2021), there had been no epidemiological study in Thailand on the effectiveness of COVID-19 vaccines and ACF as the first batch of COVID-19 vaccines was scheduled to arrive in Thailand in the first quarter of 2021. The DDC therefore commissioned a group of researchers in the DOE to estimate if and to what extent the vaccination policies, as well as ACF, could mitigate the outbreak in Samut Sakhon in a timely manner. These policy options included (i) extensive ACF with isolation of positive cases; (ii) vaccination measures to Samut Sakhon residents; and (iii) a combination of ACF and vaccination measures. All of these inform the objective of this study.

We applied a secondary analysis on quantitative data. Most model parameters were obtained from the internal database of the DOE and Samut Sakhon Provincial Public Health Office (PPHO). A further review was performed on the MEDLINE database. The review focused on articles published during 20192020. As the aim of the review was more to identify key parameters to serve as inputs for the model, rather than answering any specific research questions, no specific inclusion and exclusion criteria were set on the literature search. Some common search terms (such as COVID-19, SARS-CoV-2, generation time and serial interval) were utilized. If the interested parameters could not be identified from the recruited literature, we relied on the opinions of epidemiological experts of the MOPH. More details on the parameters are presented later in sub-section, Model validation and parameter list.

We used a compartmental susceptible-exposed-infected-recovered (SEIR) model as the base framework to assess the likely impact in a hypothesised population (N = 10,000) if ACF and vaccination measures are put into effect in Samut Sakhon. The SEIR model categorised the population into four compartments: the susceptible, the exposed (but not infectious), the infected and the recovered. Susceptible people would become infected once having contact with infected cases.13 The rate of transferring from a susceptible compartment to an exposed compartment was determined by the reproduction number (R0).14 The incubation period determined the speed of switching from an exposed compartment to an infected compartment. The length of hospital stay governed how fast a patient transferred to a recovered compartment. We divided the population into five categories (asymptomatic, mild, moderate, severe [needing intensive care], and dead). We also incorporated the concept of system dynamics in the base SEIR model to reflect the actual field operation. The infected compartment was split into two compartments, namely, infected before isolation and infected after isolation. We proposed that the benefit of ACF was mainly the reduction of time lag between being infected and reaching isolation by approximately 50%. Since, at the time of writing, the consensus on the efficacy of vaccine from various companies was yet to be finalised, we referred to the recommendation of the World Health Organization (WHO) that a widely deployed COVID-19 vaccine would be effective if the primary efficacy endpoint is at least 50%.15 In this regard, we used a figure of 50% as the vaccine efficacy parameter for transmission reduction. The simplified model framework is elicited in Figure 1.

Figure 1 Simplified model framework.

The model relied on a few key assumptions. Firstly, we assumed that the ACF did not operate all the time but functioned in a biweekly fashion. Secondly, there was in- and out-migration to and from the province. Thirdly, it is presumed that mass vaccination for a target population could be performed within a day. Fourthly, a contact between a case and each susceptible person took place at random. Lastly, all infected persons were treated at health facilities. The outcomes of interest were: (i) daily incident cases; (ii) cumulative cases; (iii) cumulative deaths; and (iv) prevalent intensive-care-unit (ICU) bed demand. As, in actual operation, vaccine coverage and degree of ACF intensity might vary. Hence, we analysed nine policy scenarios to aid policy decision, Table 1.

Table 1 Policy Scenarios of Interest

We calibrated R0 by recent evidence on new daily cases in Samut Sakhon between 1 Jan 2021 and 21 Jan 2021. During the peak of outbreak, the effective reproduction number of Samut Sakhon exceeded 3 with a range from 0.2 to 5.6.8 Two meetings among 1015 epidemiologists and public health experts in the DDC were held as part of model validation. We found that replacing R0 with 3 soundly reflected the actual situation in the province. Stella 2.0 (number: 251-401-786-859) was used to run the model. Tables 23 display key parameters and the essential formula of the model.

Table 2 List of Key Parameters

Table 3 Essential Formula of the Model

Sensitivity analysis was performed as complementary to the main analysis. While the main analysis relied on R0 of 3, this analysed the change in cumulative case volume if R0 changed to 1.5 and 2. We compared the percentage reduction of cumulative cases in each scenario against no-VAC & no-ACF scenario.

From a macro perspective, ACF-containing policies (eg, no-VAC & ACF90 and no-VAC & ACF50) demonstrated more daily incident cases at the very beginning of the outbreak (~200250 cases per day) compared with a no-VAC & no-ACF measure. However, after a week, the no-VAC & no-ACF policy showed an upward trend and reached a peak of about 260 cases per day, by day 25. The ACF-containing policies displayed a sharp spike of the incident cases by day 30, followed by a rapid decline in cases. Given the same ACF coverage, the greater the vaccination coverage was, the smaller the spike presented. VAC90 & ACF90 policy saw the lowest number of incident cases relative to other policies, Figure 2.

Figure 2 Daily incident cases by policy scenarios.

Abbreviations: no-VAC, no vaccination; no-ACF, no active case finding; ACF50, active case finding with 50% coverage; ACF90, active case finding with 50% coverage; VAC50, vaccination with 50% coverage; VAC90, vaccination with 90% coverage.

By day 90, the no-VAC & ACF90 policy contributed to about 10,500 cases, the largest among all scenarios. VAC50 & no-ACF and no-VAC & ACF50 policies came second (~9900 cases), followed by VAC-90 & no-ACF, no-VAC & ACF-90 and VAC50 & ACF50 policies (~90009300 cases).

If the vaccination covered 90% of the population in combination with 50% ACF coverage (VAC90 & ACF50) or vice versa (VAC50 & ACF90), the cumulative case toll dropped to approximately 80008200. The VAC90 & ACF90 policy resulted in the least volume of cases (~7000 cases), Figure 3.

Figure 3 Cumulative cases by policy scenarios.

Abbreviations: no-VAC, no vaccination; no-ACF, no active case finding; ACF50, active case finding with 50% coverage; ACF90, active case finding with 50% coverage; VAC50, vaccination with 50% coverage; VAC90, vaccination with 90% coverage.

All policies displayed almost the same number of cases during the first two weeks, then demonstrated the largest difference by day 40, and converged to same level again after day 80. The widest gap of cases needing ICU beds was observed when we compared no-VAC & no-ACF (~35 cases) with VAC90 & ACF90 (~20 cases). The case volume of other scenarios presented somewhere between no-VAC & no-ACF and VAC90 & ACF90 policies, Figure 4.

Figure 4 Prevalent cases needing intensive care beds.

Abbreviations: no-VAC, no vaccination; no-ACF, no active case finding; ACF50, active case finding with 50% coverage; ACF90, active case finding with 50% coverage; VAC50, vaccination with 50% coverage; VAC90, vaccination with 90% coverage.

The death toll varied across policy scenarios by a fine margin. VAC50 & no-ACF, no-VAC & no-ACF, and no-VAC & ACF50 policies yielded approximately four cases by the end of the analysis time. VAC90 & ACF90 policy exhibited fewer than three deaths in total, the smallest figure when compared with other scenarios, Figure 5.

Figure 5 Cumulative deaths by policy scenarios.

Abbreviations: no-VAC, no vaccination; no-ACF, no active case finding; ACF50, active case finding with 50% coverage; ACF90, active case finding with 50% coverage; VAC50, vaccination with 50% coverage; VAC90, vaccination with 90% coverage.

Sensitivity analysis revealed that vaccination and ACF measures produced the greatest benefit in the lens of percentage reduction in total case volume when R0 was 2. Given R0 equalling 1.5 or 3, the benefit still presented but with a lesser extent. For instance, with no-VAC & no-ACF as a reference, VAC50 & ACF50 contributed to a 38%-decline in the accumulative case number when R0 amounted to 2, but the corresponding figure appeared to be 30% and 14% when R0 was 1.5 and 3 respectively, Table 4.

Table 4 Reduction of Cumulative Cases by Day 90 Between Each Policy and No-VAC & No-ACF Policy

Overall, this study confirmed that a combination of vaccination and ACF measures contributed to favourable results in minimising the case volume and death toll. The greater the vaccination and ACF covered, the greater the volume of cases averted. In addition, the benefit of all combined strategies in terms of total case reduction would be maximised if the epidemic activity, as reflected by R0, was not too intense.

This finding corroborated the ideas of many previous studies that ACF is a key measure to contain and suppress the epidemic.16 For example, China reported the benefit of ACF to identify patients in epidemic communities.16 The ACF in China was conducted not only by the state but also by the network of communities. Examples of countries that were also successful in containing the outbreak through the use of ACF were Mongolia, Singapore, South Korea, and Vietnam.1719 Singapore used a proactive strategy to detect the suspected patients through a public prevention clinic network and promulgated the home quarantine orders for patients with mild illnesses.20,21 South Korea greatly expanded the screening sites for SARS-CoV-2 nucleic acid tests to encompass asymptomatic cases as many as possible. This included the use of public health-care clinics, drive-through centres, and walk-in screening sites.22,23

Traor and Konan suggested that the contact tracing strategy, as well as ACF, can reduce R0 to values below unity as intended for disease control, but effective control of the epidemic can be achieved when the effectiveness of contact tracing is high, and R0 is not too large. In the population where R0 is large, the epidemic may not be controlled using an ACF strategy alone.24 Our findings also upheld the idea that such a vaccination policy hugely complements the ACF measure. The situation in Samut Sakhon is very complex because the city is extremely urbanised and migrant residents are mostly living in densely populated conditions. These conditions create remarkable difficulties for ACF and other non-pharmaceutical interventions (NPI), such as physical distancing measures and individual risk modifications. At present, ACF is the major intervention in Samut Sakhon with an aim to test all 400,000 workers and isolate those who are positive for 10 days in field hospitals or factory dormitories. So far, the Government has built approximately 3000 field hospital beds. Healthcare providers use individual nasopharyngeal swabs for real-time polymerase chain reaction (Rt-PCR) testing. By average it takes at least 48 hours to obtain the swab result. This means ACF alone may not be able to detect and isolate cases as early as expected. Therefore, the Thai Government should consider an urgent launch of a vaccination policy in Samut Sakhon or in any similar settings once the COVID-19 vaccines are available.

The bottom line is, at the time of writing, the evidence of vaccine effectiveness against COVID-19 transmission is not yet fully understood.25 Many different endpoints are used in vaccine research to define efficacy depending on the pathogen, consequences of infection, and transmission dynamics. Outcomes of most randomised controlled trials (RCT) are presented as a proportional decline in disease between vaccinated participants and control participants.26 Other outcomes might include assessing sterilising immunity, severity of resultant clinical disease, and duration of infectivity. Besides, RCTs almost always represent best-case scenarios of vaccine efficacy under idealised conditions; but, in the real world, vaccine efficacy does not always predict vaccine effectiveness and such effectiveness is likely to vary across age groups and people from different walks of life as certain subpopulations in society may always face greater risks of infection or may be more vulnerable than others.27 However, the findings above are of certain value for policy consideration as the vaccine efficacy parameter applied in the model was very modest (only 50%) while recent evidence demonstrated much more favourable outcomes than the 50% figure.12 For instance, the latest interim analysis from a Phase 3 clinical trial in Russia by Logynov et al demonstrated that an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine (Sputnik V) showed 916% efficacy against COVID-19 and was well tolerated in a large cohort.11,28,29

Caution should be exercised when interpreting our findings as different models almost always rely on different assumptions, structures and parameters (even if they explored a situation in the same setting). For instance, the SEIR model conducted by the International Health Policy Programme in late December 2020 predicted that the daily incident cases of Samut Sakhon would number up to 2700 by early February 2021 given the overall effectiveness of measures (including ACF, vaccines and other social measures combined).30 This figure was approximately eight-fold larger than our estimates. However, this is not surprising as the model postulated that the value of R0 equalled 4 to reflect the force of infection at the beginning of the outbreak in Samut Sakhon while our study used a much smaller R0, as when we initiated the study the magnitude of outbreak had already subsided to certain degree (since some measures were already introduced).30 Hence, the most important value of the modelling study was to provide a clearer insight for policy decision-making for resource planning rather than identifying a perfect accuracy for forecasted numbers.31

Some limitations remain in this study. Firstly, most of the parameters applied in the model derived from the epidemic situation in Samut Sakhon. Therefore, a generalisation of the findings to other areas should be made with caution; though one may use the approach in this study as an analysis example in any similar settings. Secondly, during the period of epidemic, it is almost always difficult to conduct primary research to obtain empirical evidence as the utmost priority of the field operations was to curb the epidemic. Accordingly, many parameters in the model were obtained through authors assumptions. Though we tried to validate the findings against the opinions of experts and local providers, this does not substitute the use of empirical data. Thirdly, the model applied a deterministic approach as it is more convenient to communicate with policy makers, compared with a stochastic approach and because most parameters in the model lacked information of the distribution characteristics, which is a prerequisite for stochastic analysis. Last but not least, though we demonstrated the benefit of vaccination strategies in this setting, in real practice, actual implementation should consider many more policy angles; for instance, social acceptability (if migrants are to be the vaccination target before Thai citizens), cost-effectiveness of the policies, and operational feasibility. Further studies that address these topics are of great value. In addition, a close monitoring of the information in the field is useful, not only for the benefit of disease control but also for obtaining empirical evidence which will help refine and validate the model.

This study reaffirmed the idea that a combination of vaccination and ACF measures contributed to favourable results in reducing the number of COVID-19 cases and deaths, relative to the implementation of a single measure. The greater the vaccination and ACF coverage, the greater the volume of cases saved. We also discovered that over a three-month period of operating vaccination and ACF measures with 90% coverage, the case toll would drop by 33% compared with the scenario where no measures were implemented. Additionally, the value of all combined strategies in terms of total case reduction would be maximised if the epidemic activity as reflected by R0 was not too pronounced. To operationalise the vaccination policy in combination with ACF measures, policy makers should consider the readiness of health resources and the issue of social acceptability since COVID-vaccines are urgently needed by not only migrants but also all populations in the target area. Therefore, further studies that aim to explore the policy feasibility as well as the prioritisation of COVID-19 vaccines and other health resources are recommended. Additional research that uses empirical evidence should be conducted to complement our study that employed the analysis on secondary data, and this would help provide useful information to monitor the effectiveness of public health measures in the field.

ACF, active case finding; COVID-19, Coronavirus Disease 2019; DDC, Department of Disease Control; DOE, Division of Epidemiology; MOPH, Ministry of Public Health; NPI, Non-pharmaceutical interventions; PPHO, Provincial Public Health Office; RCT, Randomised controlled trials; Rt-PCR, Real-time polymerase-chain reaction; SEIR, susceptible-exposed-infected-recovered; VAC, vaccination; WHO, World Health Organization.

The datasets generated and/or analysed during the current study are not publicly available due to the DDCs regulation but are available from the corresponding author on reasonable request.

The study did not involve human participation, excepting the process of seeking opinions experts on model validity. Almost all the analysis was performed via secondary data. This study obtained ethics approval from the Institute for the Development of Human Research Protections (IHRP), letter head IHRP 985/2563.

The investigators are immensely grateful for the support from the DDCs and the IHPPs staff. Comments and advice from all faculties of the Field Epidemiology Training Program (FETP) of the DOE are hugely appreciated.

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agreed to be accountable for all aspects of the work.

This study received funding support from Health Systems Research Institute [Contract No. 63-162].

The authors declare that they have no conflicts of interest for this work.

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Control of COVID-19 in a migrant-populated area in Thailand | RMHP - Dove Medical Press

‘A serious threat’: Plastics we use every day are leaching hazardous chemicals, report says – USA TODAY

Lego will be replacing its plastic packaging with paper bags to make the company more sustainable. Lego plans to invest $400M into its sustainability efforts. Video Elephant

More bad news about plastic.

According to a scientific report issued Tuesday, the plastics we commonly usecontain and leach hazardous chemicals, including some that threaten human health, especially the body's endocrine system.

"Many of the plastics we use every day at home and work are exposing us to a harmful cocktail of endocrine-disrupting chemicals," the reports lead author, Jodi Flaws of the University of Illinois at Urbana-Champaign, said in a statement.

The endocrine system is a series of glands that produce and secrete hormones the body uses for a wide range of functions, according to the Endocrine Society, which co-produced the report. The hormones control many bodily functions, including respiration, reproduction, sensory perception, growth, movement and sexual development.

According to the report, which was based on hundreds of studies, endocrine-disrupting chemicals (EDCs) mimic, block or interfere with those hormones. More than 1,000manufactured chemicalsin use are EDCs.

These chemicalscan cause cancer, diabetes, reproductive disorders and neurological impairments of developing fetuses and children. The report says there are direct cause-and-effect links between the toxic chemical additives in plastics and specific health impacts to the endocrine system.

The additives are meant to make plastics more pliable or durable, more fire-resistant or antimicrobial, more UV-resistant or simply more colorful. Many of these additives disturb hormonal systems in humans and animals by leaching into liquids, food and the environment, the report says.

Forget acid rain: Plastic rain is falling across the USA

Endocrine-disrupting chemical exposure is not only a global problem today, but it poses a serious threat to future generations,report co-author Pauliina Damdimopoulouof the Karolinska Institute in Stockholm, Sweden, said in a statement. When a pregnant woman is exposed, EDCs can affect the health of her child and eventual grandchildren. Animal studies show EDCs can cause DNA modifications that have repercussions across multiple generations.

Plastic containing EDCs is used extensively in almost every aspect of our lives, includingin packaging, construction, flooring, food production and packaging, cookware, health care, childrens toys, leisure goods, furniture, home electronics, textiles, automobilesand cosmetics.

The report says the need for public policy to protect people'shealth from EDCs in plastics is all the more urgent given the industrys dramatic growth projections.

Hundreds of millions of metric tons of plastic areproduced each year.

This report clarifies that the current acceleration of plastic production, projected to increase by 30%-36% in the next six years, will greatly exacerbate EDC exposures and rising global rates of endocrine diseases," said Pamela Miller, International Pollutants Elimination Networkco-chair.

"Global policies to reduce and eliminate EDCs from plastic and reduce exposures from plastic recycling, plastic waste and incineration are imperative," Miller said.

The report was produced by theInternational Pollutants Elimination Networkwith the Endocrine Society.

Here is some information from the Endocrine Society about how to choose the least harmful plastics based on their recycling symbol and other useful tips about endocrine-disrupting chemicals.

'Choked, Strangled, Drowned': Report lays out severity of plastic harming endangered marine life

Good news? Earth's carbon dioxide emissions had record drop this year during the pandemic

Read or Share this story: https://www.usatoday.com/story/news/nation/2020/12/16/plastics-threaten-human-health-leach-chemicals-report/3905027001/

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'A serious threat': Plastics we use every day are leaching hazardous chemicals, report says - USA TODAY

Gene Therapy Shows No Long-Term Harm in Animals: Study – HealthDay News

FRIDAY, Dec. 11, 2020 (HealthDay News) -- Results from a long-term study of a gene therapy technique to prevent inherited mitochondrial disease show promise, researchers say.

Studies of the technique at Oregon Health & Science University in Portland show no adverse health effects in rhesus macaque monkeys and their offspring. The researchers said the technique could break the cycle of disease passed from mother to baby through mutations in mitochondrial DNA (mtDNA).

Though results of animal studies sometimes differ in humans, the findings bolster the scientific basis for mitochondrial replacement therapy (MRT) in human clinical trials, the study authors said.

But they added a key caveat: The study found varying levels of mtDNA from the mother that replicated and built up within some internal organs. It was not enough to cause health effects, they noted in a university news release.

"Our data show that MRT is compatible with normal development, fertility and aging in nonhuman primates without any detected adverse effects," the authors reported. "However, carry-over maternal or paternal mtDNA contributions increased substantially in selected internal tissues/organs of some MRT animals, implying the possibility of mtDNA mutation recurrence."

The findings were published online Dec. 8 in the journal Human Reproduction.

Mitochondria exist in nearly every cell of the body, according to the United Mitochondrial Disease Foundation. When they are unable to convert food and oxygen into energy throughout the body, organ systems begin to fail and even stop functioning.

The therapy under investigation replaces disease-causing mutations in a mother's egg with donor mitochondria.

The researchers said the first five monkeys born in 2009 at OHSU's Oregon National Primate Research Center with the aid of the technique all developed normally to adulthood. Their offspring did, too.

"It's reassuring that the monkeys appear to be healthy and fertile through generations," said co-author Dr. Paula Amato, professor of obstetrics and gynecology at OHSU School of Medicine. "It adds to a growing body of evidence that would support moving forward with clinical trials to prevent the transmission of mitochondrial disease."

The study offered insight about the amount of maternal mtDNA detected within organs -- a potential problem in cases where the technique is intended to prevent transmission of disease-causing mtDNA from mother to child. That's because as cells divide, this small remnant can preferentially replicate as the embryo develops, potentially causing the disease the therapy aims to prevent.

The investigators found varying amounts of mtDNA in cell samples, from 3% in blood, urine and skin cells to 16.6% in the small intestine. This is below the 60% level that would be considered disease-causing, they explained.

It is also irrelevant in cases where the technique is used to treat infertility instead of preventing disease transmission, the team noted.

The researchers also found paternal mtDNA in cells of two monkeys, which they called unusual but not unprecedented.

Shoukhrat Mitalipov, director of the OHSU Center for Embryonic Cell and Gene Therapy, said he is interested in learning more about why the minute level of mtDNA in sperm cells replicated exponentially as the embryos grew.

"The question was always there about the long-term safety of this technique," Mitalipov said. "We wanted to find out whether this procedure will somehow show negative effects later in life. We saw no adverse health effects across two generations."

Though clinical trials are ongoing in the United Kingdom and Greece, the U.S. Congress has barred the U.S. Food and Drug Administration from providing oversight for such trials in the United States.

More information

The National Human Genome Research Institute offers more on mitochondrial DNA.

SOURCE: Oregon Health & Science University, news release, Dec. 8, 2020

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Gene Therapy Shows No Long-Term Harm in Animals: Study - HealthDay News