Category Archives: Human Reproduction

Anastasia E. Lennon|Standard-Times

Shark research groups and government agencies in the United States and Canada announced Tuesday the establishment of anorganization that will unite over a dozen agencies to collaborativelystudy thewhite shark.

The New England White Shark Research Consortium joinsorganizations and universities in Massachusettssuch as the New England Aquarium and University of Massachusetts Dartmouthwith researchers in Maine, Rhode Island, New Hampshire, Arizona and Canada.

The group has two primary goals: advance researchers' current understanding of thewhite shark, and enhance public education and safety within the region.

Gregory Skomal, the senior fisheries scientist for the Massachusetts Division of Marine Fisheries (which is a consortium member),said the fatal shark attack of a 63-year-old womanoff the coast of Maine this summer prompted the creation of the consortium.

"It really pointed to a need for us to coordinate research here in New England," Skomal said, noting many people were surprised by the location of the attack even though researchers knewwhite sharks are historically found in Maine waters.

In an official statement, the consortium citedgrowing sightings of great white sharks in recent years as the "perfect time"to increase public and scientific understanding of the species, which is currently listed as vulnerableby the International Union for Conservation of Nature.

"Having a better understanding of this shark, the timing of its migration, where does it go, not only along Cape Cod, but along Rhode Island, New Hampshire,Maineand the coast of Canada," Skomal said. "Thats why we established this research consortium so we can all work under the same umbrella, share ideas, share data, share equipment and work collaboratively."

Skomal said the consortium came about somewhat informally through conversations among participating organizations and agencies, many of which have regularly collaborated.

"It was really along the lines of, 'Boy, we should formalize this arrangement under a singular umbrella,'" he said.

According to an official statement, the consortium will be "unparalleled" in its scope, usinghundreds of acoustic receivers to detect white shark movements from Rhode Island to Canada. Researchers will also use acoustic transmitters, satellite-linked tags and tissue analysis to study the shark's life stages.

Researchers will continue to studymigration patterns, habitat use, reproduction, predatory behavior and factors that drive interaction with humans. What's different now is that the consortium will facilitate greater collaboration and sharing of ideas, tools and data among new and old partners.

The University of Massachusetts Dartmouth School of Marine Science and Technology (SMAST) is also a participating member.

Megan Winton, a PhD student at the school and the chief research scientist for the Atlantic Shark Conservancy (another participating member), said she along with other partnering organizations will continue using high-tech equipment to characterize the predatory behavior and habits of the sharks off Cape Cod.

"The results of all of these studies are being used to identify areas and conditions during which white sharks are most likely to overlap with recreational water users in order to provide science-based information to improve public safety practices," Winton said in an email to the Standard-Times.

She has been working with her PhD advisor, Gavin Fay, and usingstatistical modellingto better understand wherewhite sharks go and when. Fay said he didn't have a formal role in the consortium, but that he will continue to collaboratewith Winton and other members.

Steven Cadrin, another SMAST professor, noted the consortium is also a great opportunity for the school's students to apply their educationto real-world problem-solving. The consortium's findings can shape decision-making and address community concerns, such as safety from sharks.

"Weve been applying some advanced technologies and modelling approaches to fisheries resources," Cadrin said. "White sharks giveus an opportunity to apply those advanced technologies and models... with white sharks, human safety is another application."

Other participating bodies include the Rhode Island Department of Environmental Management, the Maine Department of Marine Resources, the Massachusetts Division of Marine Fisheries, the Center for Coastal Studies, Arizona State University, the Atlantic Shark Institute and the NOAA Fisheries Apex Predators Program.

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International consortium created to study the white shark - SouthCoastToday.com

Regulation 174 Information for UK healthcare professionals

This medicinal product does not have a UK marketing authorisation but has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency for active immunization to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals aged 16 years of age and over.

As with any new medicine in the UK, this product will be closely monitored to allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection

This is a multidose vial and must be diluted before use. 1 vial (0.45 mL) contains 5 doses of 30 micrograms of BNT162b2 RNA (embedded in lipid nanoparticles).

COVID-19 mRNA Vaccine BNT162b2 is highly purified single-stranded, 5-capped messenger RNA (mRNA) produced by cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.

Excipients with known effect: For the full list of excipients, see section 6.1.

Concentrate for solution for injection.

The vaccine is a white to off-white frozen solution.

Active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.

The use of COVID-19 mRNA Vaccine BNT162b2 should be in accordance with official guidance.

COVID-19 mRNA Vaccine BNT162b2 is administered intramuscularly after dilution as a series of two doses (0.3 mL each) 21 days apart (see section 5.1).

There are no data available on the interchangeability of COVID-19 mRNA Vaccine BNT162b2 with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of COVID-19 mRNA Vaccine BNT162b2 should receive a second dose of COVID-19 mRNA Vaccine BNT162b2 to complete the vaccination series.

Individuals may not be protected until at least 7 days after their second dose of the vaccine.

For further information on efficacy, see section 5.1.

The safety and efficacy of COVID-19 mRNA Vaccine BNT162b2 in children under 16 years of age have not yet been established.

Administer the COVID-19 mRNA Vaccine BNT162b2 vaccine intramuscularly in the deltoid muscle after dilution.

Do not inject the vaccine intravascularly, subcutaneously or intradermally.

Preparation: The multidose vial is stored frozen and must be thawed prior to dilution

Frozen vials should be transferred to 2 C to 8 C to thaw. Alternatively, frozen vials may also be thawed and kept at temperatures up to 25 C for a maximum of two hours in preparation for dilution for use.

When removed from the freezer, the undiluted vaccine has a maximum shelf life of up to 5 days (120 hours) at 2 C to 8 C, and and additional 2 hours at temperatures up to 25 C in preparation for dilution.

When the thawed vial is at room temperature gently invert 10 times prior to dilution. Do not shake. Prior to dilution the vaccine should present as an off-white solution with no particulates visible. Discard the vaccine if particulates or discolouration are present.

The thawed vaccine must be diluted in its original vial with 1.8 mL sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.

Warning: Unpreserved sodium chloride 9 mg/mL (0.9%) solution for injection is the only diluent that should be used. This diluent is not provided in the vaccine carton.

Equalise vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe.

Gently invert the diluted solution 10 times. Do not shake.

The diluted vaccine should present as an offwhite solution with no particulates visible. Discard the diluted vaccine if particulates or discolouration are present.

The diluted vials should be marked with the dilution date and time and stored between 2 C to 25 C.

Use as soon as practically possible, and within 6 hours after dilution.

After dilution, the vial contains 5 doses of 0.3 mL. Withdraw the required 0.3 mL dose of diluted vaccine using a sterile needle and syringe and administer. Any unused vaccine should be discarded 6 hours after dilution.

After dilution, the vaccine should not be shipped (transported) by motor vehicle away from the site of dilution. Any shipping (transportation) by motor vehicle after dilution of the vial is at the risk of the Health Care Professional.

For instructions on disposal see section 6.6.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Any person with a history of immediate-onset anaphylaxis to a vaccine, medicine or food should not receive the COVID-19 mRNA Vaccine BNT162b2. A second dose of the COVID-19 mRNA Vaccine BNT162b2 should not be given to those who have experienced anaphylaxis to the first dose of COVID-19 mRNA Vaccine BNT162b2.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. The administration of COVID-19 mRNA Vaccine BNT162b2 should be postponed in individuals suffering from acute severe febrile illness.

Individuals receiving anticoagulant therapy or those with a bleeding disorder that would contraindicate intramuscular injection, should not be given the vaccine unless the potential benefit clearly outweighs the risk of administration.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. No data are available about concomitant use of immunosuppressants.

As with any vaccine, vaccination with COVID-19 mRNA Vaccine BNT162b2 may not protect all vaccine recipients.

No data are available on the use of COVID-19 mRNA Vaccine BNT162b2 in persons that have previously received a full or partial vaccine series with another COVID-19 vaccine.

This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially potassium-free.

This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodiumfree.

No interaction studies have been performed.

Concomitant administration of COVID-19 mRNA Vaccine BNT162b2 with other vaccines has not been studied (see section 5.1).

Do not mix COVID-19 mRNA Vaccine BNT162b2 with other vaccines/products in the same syringe.

There are no or limited amount of data from the use of COVID-19 mRNA Vaccine BNT162b2. Animal reproductive toxicity studies have not been completed. COVID-19 mRNA Vaccine BNT162b2 is not recommended during pregnancy.

For women of childbearing age, pregnancy should be excluded before vaccination. In addition, women of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose.

It is unknown whether COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk. A risk to the newborns/infants cannot be excluded. COVID-19 mRNA Vaccine BNT162b2 should not be used during breast-feeding.

It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility

COVID-19 mRNA Vaccine BNT162b2 has no or negligible influence on the ability to drive and use machines. However, some of the adverse reactions mentioned under section 4.8 may temporarily affect the ability to drive or use machines.

The safety of COVID-19 mRNA Vaccine BNT162b2 was evaluated in participants 16 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. Study BNT162-01 (Study 1) enrolled 60 participants, 18 through 55 years of age. Study C4591001 (Study 2) enrolled approximately 44,000 participants, 12 years of age or older. In Study 2, a total of 21,720 participants 16 years of age or older received at least one dose of COVID19 mRNA Vaccine BNT162b and 21,728 participants 16 years of age or older received placebo. Out of these, at the time of the analysis, 19,067 (9531 COVID-19 mRNA Vaccine BNT162b2 and 9536 placebo) were evaluated for safety 2 months after the second dose of COVID-19 mRNA Vaccine BNT162b2.

Demographic characteristics were generally similar with regard to age, gender, race and ethnicity among participants who received COVID-19 mRNA Vaccine and those who received placebo. Overall, among the participants who received COVID-19 mRNA Vaccine BNT162b2, 51.5% were male and 48.5% were female, 82.1% were White, 9.6% were Black or African American, 26.1% were Hispanic/Latino, 4.3% were Asian and 0.7% were Native American/Alaskan native.

The most frequent adverse reactions in participants 16 years of age and older were pain at the injection site (> 80%), fatigue (> 60%), headache (> 50%), myalgia (> 30%), chills (> 30%), arthralgia (> 20%) and pyrexia (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. If required, symptomatic treatment with analgesic and/or anti-pyretic medicinal products (e.g. paracetamol-containing products) may be used.

Adverse reactions reported in clinical studies are listed in this section per MedDRA system organ class, in decreasing order of frequency and seriousness. The frequency is defined as follows: very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data).

Blood and lymphatic system disorders

Nervous system disorders

Musculoskeletal and connective tissue disorders

General disorders and administration site conditions

Gastrointestinal disorders

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Coronavirus Yellow Card reporting site or search for MHRA Yellow Card in the Google Play or Apple App Store and include the vaccine brand and batch/Lot number if available.

Participants who received 58 micrograms of COVID-19 mRNA Vaccine in clinical trials did not report an increase in reactogenicity or adverse events.

In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.

Pharmacotherapeutic group: group, ATC code: not yet assigned

The nucleoside-modified messenger RNA in COVID-19 mRNA Vaccine BNT162b2 is formulated in lipid nanoparticles, which enable delivery of the RNA into host cells to allow expression of the SARSCoV-2 S antigen. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease.

The efficacy of COVID-19 mRNA Vaccine BNT162b2 was evaluated in participants 16 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa and South America. Study 1 enrolled 60 participants, 18 through 55 years of age. Study 2 is a multicentre, placebo-controlled efficacy study in participants 12 years of age and older. Randomisation was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the 56-year stratum. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19 disease. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV). There was no requirement for prophylactic use of paracetamol or analgesics. Influenza vaccines could be administered outside a window 14 days of the vaccine doses.

In Study 2, approximately 44,000 participants 12 years of age and older were randomised equally and received 2 doses of COVID-19 mRNA Vaccine or placebo with a planned interval of 21 days. The efficacy analyses included participants that received their second vaccination within 19 to 42 days after their first vaccination. Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19 disease.

The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older (18,242 in the COVID-19 mRNA Vaccine group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. Demographic characteristics were generally similar with regard to age, gender, race and ethnicity among participants who received COVID-19 mRNA BNT162b2 vaccine and those who received placebo. Overall, among the participants who received COVID-19 mRNA vaccine, 51.1% were male and 48.9% were female, 82.8% were White, 8.9% were Black or African American, 26.8% were Hispanic/Latino, 4.5% were Asian and 0.6% were Native American/Alaskan native. 57.2% were aged 16-55 years, 42.6% were aged > 55 years and 21.8% were 65 years.

At the time of the analysis of Study 2, information presented is based on participants 16 years and older. Participants had been followed for symptomatic COVID-19 disease for at least 2,214 person-years for the COVID-19 mRNA Vaccine and at least 2,222 person-years in the placebo group. There were 8 confirmed COVID-19 cases identified in the COVID-19 mRNA Vaccine group and 162 cases in the placebo group, respectively. In this analysis, compared to placebo, efficacy of COVID-19 mRNA Vaccine BNT162b2 from first COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior infection with SARS-CoV-2 was 95.0% (95% credible interval of 90.3% to 97.6%). In participants 65 years of age and older and 75 years of age and older without evidence of prior infections with SARS-CoV-2, efficacy of COVID-19 mRNA Vaccine BNT162b2 was 94.7% (two-sided 95% confidence interval of 66.7% to 99.9%) and 100% (two-sided 95% confidence interval of -13.1% to 100.0%) respectively.

In a separate analysis, compared to placebo, efficacy of COVID-19 mRNA Vaccine from first COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior infection with SARS-CoV-2 was 94.6% (95% credible interval of 89.9% to 97.3%).

There were no meaningful clinical differences in overall vaccine efficacy in participants who were at risk of severe COVID-19 disease including those with one or more comorbidities that increase the risk of severe COVID-19 disease (e.g. asthma, BMI 30 kg/m2, chronic pulmonary disease, diabetes mellitus, hypertension).

Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 disease.

Not applicable.

Non-clinical data reveal no special hazard for humans based on a conventional study of repeat dose toxicity. Animal studies into potential toxicity to reproduction and development have not been completed.

This vaccine contains polyethylene glycol/macrogol (PEG) as part of ALC-0159.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6 months at -80 C to -60 C.

Store in a freezer at -80 C to -60 C.

Store in the thermal container at -90 C to -60 C.

Store in the original package in order to protect from light.

Once removed from the freezer, the undiluted vaccine can be stored for up to 5 days at 2 C to 8 C, and up to 2 hours at temperatures up to 25 C, prior to use. During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Thawed vials can be handled in room light conditions.

After dilution, store the vaccine at 2 C to 25 C and use as soon as practically possible and within 6 hours. The vaccine does not contain a preservative. Discard any unused vaccine.

Once diluted, the vials should be marked with the dilution time and discarded within 6 hours of dilution.

Once thawed, the vaccine cannot be re-frozen.

Concentrate for solution for injection for 5 doses in a 2 mL clear vial (type I glass) with a stopper (bromobutyl) and a flip-off plastic cap with aluminium seal.

Pack size: 195 vials

When removed from the freezer, the vaccine has a maximum possible shelf life of up to 5 days when stored at 2-8 C (label to be added once box removed from freezer). A 195 vial pack may take 3 hours to thaw at 2-8oC.

The product can alternatively be defrosted and kept for up to 2 hours at up to 25 C before being diluted for use. This facilitates immediate thaw and use when removed directly from the freezer to 25 C. In this instance the product is to be diluted within 2 hours of removing from the freezer.

Once thawed, the vaccine cannot be refrozen.

After dilution the vaccine should be used as soon as is practically possible and within 6 hours of dilution; it can be stored at 2-25 C during this period. From a microbiological point of view, it would not normally be considered good practice to store diluted product for 6 hours at 25C before being administered. The product would ideally be used as soon as practically possible after dilution.

The vaccine does not contain a preservative. Discard any unused vaccine

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

For instructions on dose preparation of the medicinal product before administration, see section 4.2.

Not applicable.

Not applicable.

Not applicable.

Link:
Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 vaccine - GOV.UK

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

Tuesday, November 24, 2020

The California Court of Appeal, Third Appellate District (Sacramento), has upheld the listing of bisphenol A (BPA) as a reproductive toxicant under Proposition 65 (Prop 65). Prop 65 a right-to-know law that requires individuals to receive a clear and reasonable warning before being exposed to certain chemicals that California deems to be carcinogens or reproductive toxicants.

By way of background, the National Toxicology Program Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR) published a monograph in 2008, titled, Monograph on the Potential Human Reproductive and Developmental Effects of [BPA]. The monograph, which primarily addressed studies in laboratory animals, stated that it is possible that BPA can affect human development or reproduction. Based on NTP-CERHRs finding that BPA can affect human development or reproduction, the National Resources Defense Council (NRDC) petitioned Californias Office of Environmental Health Hazard Assessment (OEHHA) requesting that BPA be listed under Prop 65 as a chemical known to cause reproductive toxicity.

After reviewing the NTP-CERHR monograph, the Developmental and Reproductive Toxicant Identification Committee (DART-IC)an OEHHA committee of qualified scientific expertsvoted not to list BPA as a reproductive toxicant based on the states qualified experts listing mechanism in 2009. DART-IC members expressed skepticism as to whether the conclusions from the animal studies could be extrapolated to humans.

Although DART-IC decided to not list BPA as a reproductive toxicant, on January 24, 2013, OEHHA issued a notice of intent to add BPA to the list of chemicals known to the State of California to cause reproductive toxicity. In response, on March 1, 2013, the American Chemistry Council (ACC) filed a complaint in Sacramento County Superior Court seeking to enjoin OEHHA from adding BPA to the Prop 65 list. In its complaint, ACC stated that animal studies only provide limited evidence for developmental effects in human and that that OEHHA abused its discretion by refusing the 2009 DART-IC recommendation not to list BPA as a reproductive toxicant. On March 27, 2013, ACC also filed a motion for a preliminary injunction to enjoin OEHHA from listing or taking any further action in listing BPA with respect to Prop 65.

Despite ACCs legal challenge, OEHHA published notice, effective April 11, 2013, stating that it was adding BPA to the list of chemicals known to the State of California to cause reproductive toxicity. However, in response to ACCs March 1, 2013 complaint, the trial court granted ACCs motion for a preliminary injunction, directing OEHHA to immediately remove BPA from the Prop 65 list. Therefore, BPA was delisted on April 19, 2013.

Eventually, the trial court denied the relief requested by ACC on March 27, 2013 and ACC appealed that decision. On October 19, 2020, the California Court of Appeal upheld the trial courts decision to allow the listing of BPA as a reproductive toxicant under Prop 65. In the ruling (seeAmerican Chemistry Council v. Office of Environmental Health Hazard Assessment et al.), the Court of Appeal stated that adverse effects observed at high doses in animal studies are biologically plausible in humans. The Court of Appeal added, OEHHA did not abuse its discretion in listing BPA based on the monograph. Therefore, we conclude that the trial court did not abuse its discretion in denying ACC the relief requested in the amended complaint.

In a separate action, not related toAmerican Chemistry Council v. Office of Environmental Health Hazard Assessment et al., OEHHA listed BPA as a chemical known to cause female reproductive toxicity under the states Prop 65 qualified expert listing mechanism. In the AgencysMay 11, 2015 noticeannouncing that BPA was being listed as a reproductive toxicant under Prop 65, OEHHA stated that, in 2015, DART-IC determined that BPA was clearly shown through scientifically valid testing according to generally accepted principles to cause reproductive toxicity based on the female reproductive endpoint. OEHHA claimed that ascientific review of BPA and reproductive health, published in the August 2014 issue ofEnvironmental Health Perspectives, identified substantial new epidemiological and toxicological data on female reproductive toxicity that have become available subsequent to the DART-ICs consideration of BPA in 2009. In apress release, ACC disagreed with DART-ICs decision and stated, The decision is not supported by the extensive scientific record presented to the committee and is completely contrary to explicit input provided by the U.S. Food and Drug Administration (FDA).

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Calif. Prop 65: BPA Listed as Reproductive Toxicant - The National Law Review

Hadley Horch and Scott McEachern

The second session featured Horch alongside noted anthropologist and former Bowdoin professor Scott MacEachern, who is now vice chancellor for academic affairs at Duke Kunshan University in China. This discussion, titled Eugenics and the IQ Test, revisited the theme of the misuse of scientific knowledge. Particular attention was paid to the problems of trying to define and measure intelligence. Any documented difference in IQ scores between different racial and ethnic groups says more about inequality in societies than it does about intelligence, said Horch. Environmental and cultural factors are rarely well-controlled in these comparison studies, she added.

There are important lessons to be learned from studying the impact of eugenics in the last century, said Horch and Logan. Today we are exposed to brand new sources of information, vast troves of genomic information that weve never had before, said Logan, and in managing that there comes huge ethical responsibility. He is referring to the era ushered in by the Human Genome Projecta multiyear international scientific effort to map all human genes. The thirteen-year project, which concluded in 2003, has given scientists the most accurate reading yet of the entire human genetic sequence and greater increased our capacity to survey the genomes of humans and other organisms. The discovery, said Logan, marked a quantum leap in human knowledge. There are, however, problems with the huge data sets used in the project, said Horch, because about 70 percent of the genetic information sampled is from people of white European stock. This points to an inherent bias in the data, she explained, so there is much in the way of complexity and richness that is not represented.

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Seminars Explore the Immorality of the Eugenics Movement and Its Implications Today - Bowdoin News

The study focused on 142 North American bird species, including the ash-throated flycatcher shown above. Credits: David Keeling / California Polytechnic State University.

Human-produced noise and light pollution are troublesome to our avian neighbors, according to new research from a team at California Polytechnic State University, published Nov. 11 in Nature.

Using NASA satellite data, the researchers got a birds-eye view of how noise and light negatively affected bird reproduction in North America. The team also discovered that these factors might interact with or even mask birds responses to the effects of climate change.

Bird populations have declined by about 30 percent in the last few decades. Scientists and land managers seeking to understand what caused the decline and reverse the trend had largely overlooked the effects of noise and light pollution, until recent studies suggested that these stressors could harm certain types of birds.

Prior to the launch of the Visible Infrared Imaging Radiometer Suite (VIIRS) instrument aboard the joint NASA-National Oceanic and Atmospheric Association Suomi National Polar-orbiting Partnership satellite in 2011, high-resolution light pollution data didnt exist on such a large scale. This new study has produced a continent-wide picture utilizing VIIRS data.

Our study provides comprehensive evidence that noise and light can profoundly alter reproduction of birds, even when accounting for other aspects of human activities, said Clint Francis, a biologist at California Polytechnic State University, San Luis Obispo, California, one of the lead authors on the study.

The research team looked at a vast collection of data sets including those collected by citizen scientists through the NestWatch Program to assess how light and noise affected the reproductive success of 58,506 nests from 142 bird species across North America.

They considered several factors for each nest, including the time of year when breeding occurred and whether at least one chick fledged or flew from the nest.

Birds reproduction coincides with peak food availability to feed their young, as daylight cues signal to breed around the same time each year.

The researchers found that light pollution causes birds to begin nesting as much as a month earlier than normal in open environments, such as grasslands or wetlands, and 18 days earlier in forested environments.

The consequence could be a mismatch in timing for example, hungry chicks may hatch before their food is readily available. If that happens, these early season nests may be less successful at fledging at least one chick, but the situation is complicated by climate change.

As the planet warms, birds food is available earlier due to warmer weather. Birds that maintain their historical breeding times because their internal clocks are set to changes in daylength may have fewer chicks survive because the food source they rely on already came and went.

We discovered that the birds that advanced the timing of their reproduction in response to increased light pollution actually have better reproductive success, Francis said. A likely interpretation of this response is that light pollution actually allows these birds to catch up to the shift towards earlier availability of food due to climate change.

Many areas of the United States are significantly brighter at night due to human-produced light pollution. This map constructed with VIIRS data shows areas with increased light pollution (yellow and pink) compared to the typical brightness of the night sky (darker blues). Credits: Francis et al.These findings suggest two conclusions about birds responses to climate change. First, at least temporarily, birds in lit conditions may be tracking climate change better than those in dark areas.

Second, when scientists thought birds were adjusting their reproductive timing to climate change, birds may have actually been instead responding to light cues since many studies were done in areas exposed to some light pollution.

When considering noise pollution, results showed that birds that live in forested environments tend to be more sensitive to noise than birds in open environments.

Researchers delved into greater detail in 27 different bird species, looking for physical traits that could explain the variations in species responses to light and noise. A birds ability to see in low light and the pitch of its call were related to species responses to light and noise pollution.

The more light a birds eye is capable of taking in, the more that species moved its breeding time earlier in the year in response to light pollution, and the more that species benefited from light pollution with improved nest success.

Noise pollution delayed nesting for birds whose songs are at a lower frequency and thus more difficult to hear through low-frequency human noise. Mating decisions are made based on the males song, and in some cases, females need to hear the males song to become physically ready to breed.

These trait and environment-specific results have strong implications for managing wild lands. Developers and land managers could use this study to understand how their plans are likely to affect birds. For example, Francis says, Is it a forest bird? If so, it is likely that it is more sensitive to light and noise.

The study is the first step toward a larger goal of developing a sensitivity index for all North American birds. The index would allow managers and conservationists to cross-reference multiple physical traits for one species to assess how factors such as light and noise pollution would affect each species.

Rachel Henry works for NASA.

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Earth News: Noise and light pollution from humans alter bird reproduction - Lake County News