scholarly journals Estimated Cancer Risks Associated with Nitrosamine Contamination in Commonly Used Medications

2021 ◽  
Vol 18 (18) ◽  
pp. 9465
Author(s):  
Kate Li ◽  
Karin Ricker ◽  
Feng C. Tsai ◽  
ChingYi J. Hsieh ◽  
Gwendolyn Osborne ◽  
...  
Keyword(s):  
Environmental Protection Agency ◽  
Animal Species ◽  
Protection Agency ◽  
Cancer Risks ◽  
The Us ◽  
Treatment Of Hypertension ◽  
Us Fda

Many nitrosamines are potent carcinogens, with more than 30 listed under California’s Proposition 65. Recently, nitrosamine contamination of commonly used drugs for treatment of hypertension, heartburn, and type 2 diabetes has prompted numerous Food and Drug Administration (FDA) recalls in the US. These contaminants include the carcinogens NDMA (N-nitrosodimethylamine) and NDEA (N-nitrosodiethylamine) and the animal tumorigen NMBA (N-nitroso-N-methyl-4-aminobutyric acid). NMBA and NDEA are metabolically and/or structurally related to NDMA, an N-nitrosomethyl-n-alkylamine (NMA), and 12 other carcinogenic NMAs. These nitrosamines exhibit common genotoxic and tumorigenic activities, with shared target tumor sites amongst chemicals and within a given laboratory animal species. We use the drug valsartan as a case study to estimate the additional cancer risks associated with NDMA and NDEA contamination, based on nitrosamine levels reported by the US FDA, cancer potencies developed by California’s Proposition 65 program and the US Environmental Protection Agency (EPA), and specific exposure scenarios. These estimates suggest that nitrosamine contamination in drugs that are used long-term can increase cancer risks and pose a serious concern to public health.

Tech advances will bolster long-term copper demand

2019 ◽  
Keyword(s):  
Environmental Protection ◽  
Environmental Protection Agency ◽  
Copper Price ◽  
Metal Exchange ◽  
London Metal Exchange ◽  
Protection Agency ◽  
Content Type ◽  
Copper Producer ◽  
The Us

Subject The copper market. Significance The copper price has picked up by nearly 9% this year after weakening unexpectedly through 2018, losing 17.5%. Unusually, the slide was accompanied by metal inventories dropping steadily on the London Metal Exchange, Comex and Shanghai Metals Exchange. Stocks peaked at 900 kilotonnes (kt) in March 2018 before plummeting by 65% to start the year at the lowest since 2014. This rare combination of falling inventories and weakening prices has yet to find a viable explanation. Impacts Zambian import duties on concentrate has prompted 366 kt of capacity to be shutdown, reducing supply on the market. Boosting the outlook for US output, the US Environmental Protection Agency has approved Hudbay’s 112-kt-per-year Rosemont mine in Arizona. Chilean miner Codelco is spending 4.9 billion dollars to mine underground at Chuquicamata, aiming to extend operations by 40 years. Indonesia, the ninth largest copper producer, is to redirect output towards local smelters; it has cut annual export quotas by 25-75%.

scholarly journals Regulations Matter: Epistemic Monopoly, Domination, Patents, and the Public Interest

2021 ◽  
Author(s):  
Zahra Meghani
Keyword(s):  
Public Interest ◽  
Environmental Protection Agency ◽  
New Technologies ◽  
Regulatory Agencies ◽  
Protection Agency ◽  
The Public ◽  
The Us ◽  
Unbiased Manner ◽  
Technological Products

AbstractThis paper argues that regulatory agencies have a responsibility to further the public interest when they determine the conditions under which new technological products may be commercialized. As a case study, this paper analyzes the US 9th Circuit Court’s ruling on the efforts of the US Environmental Protection Agency (EPA) to regulate an herbicide meant for use with seed that are genetically modified to be tolerant of the chemical. Using that case, it is argued that when regulatory agencies evaluate new technological products, they have an obligation to draw on data, analyses, and evaluations from a variety of credible epistemic sources, and not rely solely or even primarily on the technology developer. Otherwise, they create conditions for their own domination and that of the polity by the technology developer. Moreover, in the interest of advancing the public interest, regulatory agencies must evaluate new technologies in a substantively and procedurally unbiased manner.

The Hornsby Bend Hyacinth Facility in Austin, Texas

1987 ◽  
Vol 19 (10) ◽  
pp. 41-49 ◽  
Author(s):  
Ray Dinges ◽  
Jim Doersam
Keyword(s):  
Environmental Protection ◽  
Environmental Protection Agency ◽  
Plant Material ◽  
Animal Species ◽  
Performance Data ◽  
Operational Performance ◽  
Fish Production ◽  
Protection Agency ◽  
Functional Characteristics ◽  
The City

The Hornsby Bend Hyacinth Facility, the first such system built under the U. S. Environmental Protection Agency “Construction Grants Program”, represents the culmination of over a decade of experience at the City of Austin with hyacinth treatment. The facility consists of three culture basins 265 m in length with an area of 1.6 ha. To permit year-round hyacinth culture, basins are covered with a 2.06 ha unitary greenhouse structure. Fenced exclusion areas at intervals along sides of basins serve as natural aerators and enhance fish production. The system, operated in an aerobic mode, was designed to daily treat about three million liters of sludge lagoon supernatant. Exclusion of large vertebrate predators and stocking of basins with selected animal species will provide a unique ecosystem. Basins were planted with hyacinth in late October, 1985 and discharge commenced on February 3, 1986. Functional characteristics and ecological considerations of the facility are discussed and operational performance data are presented. Maintenance harvesting of hyacinth and disposition of plant material are described. Application of greenhoused hyacinth treatment systems are addressed.

Abstract 17027: Generalizability of the US FDA Label for Dapagliflozin to Patients With Heart Failure With Reduced Ejection Fraction in the GWTG-HF Registry

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Muthiah Vaduganathan ◽  
Stephen Greene ◽  
Shuaiqi Zhang ◽  
maria v grau-sepulveda ◽  
Adam D Devore ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Ejection Fraction ◽  
Care Facility ◽  
Eligibility Criteria ◽  
Discharge Data ◽  
Reduced Ejection Fraction ◽  
Type 2 Dm ◽  
The Us ◽  
Us Fda

Background: In May 2020, dapagliflozin was approved by the US FDA as the first SGLT-2 inhibitor for HF with reduced ejection fraction (HFrEF) based on the pivotal DAPA-HF trial. Limited data are available characterizing its generalizability to US clinical practice. Methods: We studied patients with HFrEF (≤40%) hospitalized at 406 sites in the Get With The Guidelines (GWTG)-HF registry admitted between Jan 2014 - Sept 2019. We excluded patients who left against medical advice, transferred to an acute care facility or to hospice, or had missing critical data. We applied the FDA label (excluding eGFR<30 mL/min/1.73 m 2 , dialysis, or type 1 DM) and eligibility criteria of DAPA-HF to the GWTG-HF registry sample. Results: Among 154,714 patients hospitalized with HFrEF, 125,497 (81.1%) would be candidates for dapagliflozin under the FDA label. Across 355 sites with ≥10 hospitalizations, median proportion of FDA label candidates was 81.1% (77.8%-84.6%). This proportion was similar across all study years (80.4-81.7%) and higher among those without type 2 DM than with type 2 DM (85.5% vs. 75.6%). Among GWTG-HF participants, the most frequent reason for not meeting the FDA label was eGFR<30 mL/min/1.73 m 2 (n=28,605). Among patients with available paired admission and discharge data, 14.2% had eGFR<30 mL/min/1.73 m 2 at both time points, while 3.8% developed eGFR<30 mL/min/1.73 m 2 by discharge. While there were more women, more Black patients, and less Asian patients in GWTG-HF, clinical characteristics were qualitatively similar between DAPA-HF trial and GWTG-HF registry participants. Compared with the DAPA-HF trial cohort, there was lower use of evidence-based HF therapies among GWTG-HF patients ( Table ). Conclusions: These data from a large, contemporary US hospitalized HF registry suggest that 4 out of 5 patients with HFrEF (with or without type 2 DM) would be candidates for initiation of dapagliflozin, and support its broad generalizability to US clinical practice.

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