Differences in the carcinogenic evaluation of glyphosate between the International Agency for Research on Cancer (IARC) and the European Food Safety Authority (EFSA)

The International Agency for Research on Cancer (IARC) Monographs Programme identifies chemicals, drugs, mixtures, occupational exposures, lifestyles and personal habits, and physical and biological agents that cause cancer in humans and has evaluated about 1000 agents since 1971. Monographs are written by ad hoc Working Groups (WGs) of international scientific experts over a period of about 12 months ending in an eight-day meeting. The WG evaluates all of the publicly available scientific information on each substance and, through a transparent and rigorous process,1 decides on the degree to which the scientific evidence supports that substance's potential to cause or not cause cancer in humans. For Monograph 112,2 17 expert scientists evaluated the carcinogenic hazard for four insecticides and the herbicide glyphosate.3 The WG concluded that the data for glyphosate meet the criteria for classification as a probable human carcinogen. The European Food Safety Authority (EFSA) is the primary agency of the European Union for risk assessments regarding food safety. In October 2015, EFSA reported4 on their evaluation of the Renewal Assessment Report5 (RAR) for glyphosate that was prepared by the Rapporteur Member State, the German Federal Institute for Risk Assessment (BfR). EFSA concluded that ?glyphosate is unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential?. Addendum 1 (the BfR Addendum) of the RAR5 discusses the scientific rationale for differing from the IARC WG conclusion. Serious flaws in the scientific evaluation in the RAR incorrectly characterise the potential for a carcinogenic hazard from exposure to glyphosate. Since the RAR is the basis for the European Food Safety Agency (EFSA) conclusion,4 it is critical that these shortcomings are corrected

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Background: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. Funding: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D’Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.

BACKGROUND: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. METHODS: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. FINDINGS: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. INTERPRETATION: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials

Phase transformations of the NaA10₂0-A1₂0₃ system

honors thesisCollege of ScienceChemistryThe subject of this this comes as a direct consequence of study on the Sodium-Sulfur Battery. The Sodium-Sulfur Battery is a lightweight, very efficient energy s6urce, which has been proposed for use in the electric car. It consists of a ceramic tube (S"-Alumina) which acts as an electrolyte and conducts Sodium ions from the liquid Sodium contained in it, to the Sulfur-impregnated Graphite on the outside

Minimal-invasive approach to pancreatoduodenectomy is associated with lower early postoperative morbidity

We aim to investigate the impact of the operation time for pancreatoduodenectomy (PD) in different surgical approaches. The NSQIP database was used to examine the clinical data of patients underwent PD during 2014–2016. We sampled a total of 6151 patients who underwent elective PD. Of these, 452(7.3%) had minimally invasive approaches to PD. Minimally invasive approaches (MIS) to PD was associated with a significant decrease in morbidity of patients (AOR: 0.67, P < 0.01). Following risk adjustment for morbidity predictors, operation length was statistically associated with post-operative morbidity (AOR: 1.002, P < 0.01). Although MIS procedures were significantly longer operations compared to open procedures (443 min vs. 371 min, CI: 53–82 min, P < 0.01), MIS approaches were associated with significantly decreased morbidity in low stage tumors (stage zero-II) (51.3% vs. 56.2%, AOR: 0.72, P = 0.03) and advanced stage disease (stage III-IV) (50% vs. 60.3%, AOR: 0.38, P = 0.04). Minimally invasive approaches to PD were associated with decreased post-operative morbidity, even though they were associated with longer operative times. Operation length also significantly correlated with postoperative morbidity. •The minimally invasive approach to pancreatoduodenectomy can decrease morbidity even though it was associated with longer operative times.•Operation length significantly correlated with postoperative morbidity.•Our data reveals that prolongation of operative times should not prohibit minimally invasive approach in pancreas surgery

Roux-en-Y gastric bypass is a safe and effective option that improves major Co-Morbidities associated with obesity in an older, veteran population.

BACKGROUND: Though over one-third of veterans suffer from obesity and its associated comorbidities, bariatric surgery (deleted: is seldom offered) is less commonly offered than in other populations. METHODS: We reviewed surgical outcomes using CPRS/Vista data of (deleted 308) 315 Roux-en-Y gastric bypass (RYGB) cases performed at a major VA Medical Center (1995-2017). RESULTS: Patients were 69% male, with an average age 52 (65% over 50), and were followed for an average of 8 years; 158 (51%) underwent laparoscopic surgery, and the remaining open. Outcomes were: 30-day mortality- Open: 1.3%, Lap: 0%; anatomic leak-open: 0.3%, Lap: 0%. A total of 32 (10%) Clavien-Dindo ≥3 complications occurred. At 5 and 15 years, average BMI decreased from 47 preoperatively to 33.3 and 31 respectively, while excess body weight loss was 68%, and 80%, respectively. Co-morbidity resolution rates were between 70 and 80% diabetes, sleep apnea, hyperlipidemia, GERD, (delete - hypertension), and NASH. CONCLUSIONS: RYGB offers sustained, long-term weight loss with significant resolution of major comorbidities in older veterans, with acceptably low morbidity and mortality

Patient Co-Morbidity and Functional Status Influence the Occurrence of Hospital Acquired Conditions More Strongly than Hospital Factors.

BackgroundNever events (NE) and hospital-acquired conditions (HAC) are used by Medicare/Medicaid Services to define hospital performance measures that dictate payments/penalties. Pre-op patient comorbidity may significantly influence HAC development.MethodsWe studied 8,118,615 patients from the NIS database (2002-2012) who underwent upper/lower gastrointestinal and/or hepatopancreatobiliary procedures. Multivariate analysis, using logistic regression, was used to identify HAC and NE risk factors.ResultsA total of 63,762 (0.8%) HAC events and 1645 (0.02%) NE were reported. A total of 99.9% of NE were retained foreign body. Most frequent HAC were: pressure ulcer stage III/IV (36.7%), poor glycemic control (26.9%), vascular catheter-associated infection (20.3%), and catheter-associated urinary tract infection (13.7%). Factors correlating with HAC included: open surgical approach (AOR: 1.25, P &lt; 0.01), high-risk patients with significant comorbidity [severe loss function pre-op (AOR: 6.65, P &lt; 0.01), diabetes with complications (AOR: 2.40, P &lt; 0.01), paraplegia (AOR: 3.14, P &lt; 0.01), metastatic cancer (AOR: 1.30, P &lt; 0.01), age &gt; 70 (AOR: 1.09, P &lt; 0.01)], hospital factors [small vs. large (AOR: 1.07, P &lt; 0.01), non-teaching vs teaching (AOR: 1.10, P &lt; 0.01), private profit vs. non-profit/governmental (AOR: 1.20, P &lt; 0.01)], severe preoperative mortality risk (AOR: 3.48, P&nbsp;&lt; 0.01), and non-elective admission (AOR: 1.38, P &lt; 0.01). HAC were associated with increased: hospitalization length (21 vs 7&nbsp;days, P &lt; 0.01), hospital charges ($164,803 vs$54,858, P &lt; 0.01), and mortality (8 vs 3%, AOR: 1.14, P &lt; 0.01).ConclusionHAC incidence was highest among patients with severe comorbid conditions. While small, non-teaching, and for-profit hospitals had increased HAC, the strongest HAC risks were non-modifiable patient factors (preoperative loss function, diabetes, paraplegia, advanced age, etc.). This data questions the validity of using HAC as hospital performance measures, since hospitals caring for these complex patients would be unduly penalized. CMS should consider patient comorbidity as a crucial factor influencing HAC development