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Tracheobronchial tree size changes may predict IPF outcomes
Changes in tracheobronchial tree size may serve as a practical and noninvasive method for predicting disease severity in patients diagnosed with idiopathic pulmonary fibrosis, according to data from 150 adults.
To determine the potential predictive value of tracheobronchial tree changes on mortality, Ankush Ratwani, MD, of Georgetown University, Washington, and colleagues reviewed data from adults with IPF seen at a single center between March 2012 and December 2016. The findings were presented at the CHEST annual meeting.
The researchers measured the tracheal diameters of the patients and used the GAP index, an established system for predicting mortality in IPF patients, to determine a relationship. Overall, they found a significant correlation between GAP index scores and increasing tracheobronchial tree size across eight measurements of different levels along the tracheobronchial tree “with an increase in GAP index stage for every level of increase in tracheal measurements (P less than .005),” they noted.
Measurements included the anterior-posterior diameter at the subglottic level, aortic arch, carina, right main stem bronchus, and left main stem bronchus, as well as transverse diameter assessment at the subglottis, aortic arch, and carina. The average anterior-posterior tracheal diameters were 21.77 mm for the subglottis, 21.84 mm for the aortic arch, 20.47 mm for the carina, 15.19 for the right main stem bronchus, and 14.21 mm for the left main stem bronchus.
No correlation appeared between tracheal size and lung volume, which suggests that enlargement of the trachea is likely caused by other factors beyond fibrosis, and next steps for research should determine whether tracheal size is an independent predictor of mortality in IPF patients, the investigators noted.
“With the field of treatment and management changing for IPF over the last few years, it has becoming increasingly important to prognose these patients in order to find where they fit in the spectrum for treatment or lung transplant,” Dr. Ratwani said in an interview. “Additionally, there needs to be a noninvasive measure to show disease progression, such as with using CT scans, and correlate with other prognostic indicators to hopefully create a regression formula that encompasses multiple parameters,” he explained.
“The results were surprising in that there was a correlation of a radiographic measure that has not been looked at previously with a validated measure of prognostication in IPF (GAP Index),” Dr. Ratwani said.
Although the findings do not imply more than a correlation, the results serve as “a good start to validate the theory that as the distal airways enlarge (traction bronchiectasis) in later stages of IPF, so may the proximal airways, which may be used to easily measure disease progression and guide the conversation for transplant or treatment,” Dr. Ratwani noted. His next steps for research include studying transplant-free survival in correlation with tracheal size, as well as serial changes between CT scans with correlations of lung volumes and survival.
Changes in tracheobronchial tree size may serve as a practical and noninvasive method for predicting disease severity in patients diagnosed with idiopathic pulmonary fibrosis, according to data from 150 adults.
To determine the potential predictive value of tracheobronchial tree changes on mortality, Ankush Ratwani, MD, of Georgetown University, Washington, and colleagues reviewed data from adults with IPF seen at a single center between March 2012 and December 2016. The findings were presented at the CHEST annual meeting.
The researchers measured the tracheal diameters of the patients and used the GAP index, an established system for predicting mortality in IPF patients, to determine a relationship. Overall, they found a significant correlation between GAP index scores and increasing tracheobronchial tree size across eight measurements of different levels along the tracheobronchial tree “with an increase in GAP index stage for every level of increase in tracheal measurements (P less than .005),” they noted.
Measurements included the anterior-posterior diameter at the subglottic level, aortic arch, carina, right main stem bronchus, and left main stem bronchus, as well as transverse diameter assessment at the subglottis, aortic arch, and carina. The average anterior-posterior tracheal diameters were 21.77 mm for the subglottis, 21.84 mm for the aortic arch, 20.47 mm for the carina, 15.19 for the right main stem bronchus, and 14.21 mm for the left main stem bronchus.
No correlation appeared between tracheal size and lung volume, which suggests that enlargement of the trachea is likely caused by other factors beyond fibrosis, and next steps for research should determine whether tracheal size is an independent predictor of mortality in IPF patients, the investigators noted.
“With the field of treatment and management changing for IPF over the last few years, it has becoming increasingly important to prognose these patients in order to find where they fit in the spectrum for treatment or lung transplant,” Dr. Ratwani said in an interview. “Additionally, there needs to be a noninvasive measure to show disease progression, such as with using CT scans, and correlate with other prognostic indicators to hopefully create a regression formula that encompasses multiple parameters,” he explained.
“The results were surprising in that there was a correlation of a radiographic measure that has not been looked at previously with a validated measure of prognostication in IPF (GAP Index),” Dr. Ratwani said.
Although the findings do not imply more than a correlation, the results serve as “a good start to validate the theory that as the distal airways enlarge (traction bronchiectasis) in later stages of IPF, so may the proximal airways, which may be used to easily measure disease progression and guide the conversation for transplant or treatment,” Dr. Ratwani noted. His next steps for research include studying transplant-free survival in correlation with tracheal size, as well as serial changes between CT scans with correlations of lung volumes and survival.
Changes in tracheobronchial tree size may serve as a practical and noninvasive method for predicting disease severity in patients diagnosed with idiopathic pulmonary fibrosis, according to data from 150 adults.
To determine the potential predictive value of tracheobronchial tree changes on mortality, Ankush Ratwani, MD, of Georgetown University, Washington, and colleagues reviewed data from adults with IPF seen at a single center between March 2012 and December 2016. The findings were presented at the CHEST annual meeting.
The researchers measured the tracheal diameters of the patients and used the GAP index, an established system for predicting mortality in IPF patients, to determine a relationship. Overall, they found a significant correlation between GAP index scores and increasing tracheobronchial tree size across eight measurements of different levels along the tracheobronchial tree “with an increase in GAP index stage for every level of increase in tracheal measurements (P less than .005),” they noted.
Measurements included the anterior-posterior diameter at the subglottic level, aortic arch, carina, right main stem bronchus, and left main stem bronchus, as well as transverse diameter assessment at the subglottis, aortic arch, and carina. The average anterior-posterior tracheal diameters were 21.77 mm for the subglottis, 21.84 mm for the aortic arch, 20.47 mm for the carina, 15.19 for the right main stem bronchus, and 14.21 mm for the left main stem bronchus.
No correlation appeared between tracheal size and lung volume, which suggests that enlargement of the trachea is likely caused by other factors beyond fibrosis, and next steps for research should determine whether tracheal size is an independent predictor of mortality in IPF patients, the investigators noted.
“With the field of treatment and management changing for IPF over the last few years, it has becoming increasingly important to prognose these patients in order to find where they fit in the spectrum for treatment or lung transplant,” Dr. Ratwani said in an interview. “Additionally, there needs to be a noninvasive measure to show disease progression, such as with using CT scans, and correlate with other prognostic indicators to hopefully create a regression formula that encompasses multiple parameters,” he explained.
“The results were surprising in that there was a correlation of a radiographic measure that has not been looked at previously with a validated measure of prognostication in IPF (GAP Index),” Dr. Ratwani said.
Although the findings do not imply more than a correlation, the results serve as “a good start to validate the theory that as the distal airways enlarge (traction bronchiectasis) in later stages of IPF, so may the proximal airways, which may be used to easily measure disease progression and guide the conversation for transplant or treatment,” Dr. Ratwani noted. His next steps for research include studying transplant-free survival in correlation with tracheal size, as well as serial changes between CT scans with correlations of lung volumes and survival.
FROM CHEST 2017
More savings available from generic oral contraceptives
, according to an analysis of almost 20,000 OC-prescribing events.
Brand OCs with available generics represented 44% of expenditures for all OCs in both 2010 and 2014, while generics had 56% and 55% of spending in 2010 and 2014 and brand names without generics took 0% and 1%, respectively, Mark Chee and his associates wrote in a report published in JAMA Internal Medicine.
For the whole 4-year period, brand OCs accounted for 24% of all prescriptions and 42% of all expenditures for the 19,944 OC prescribing events included in the analysis of data from the Medical Expenditure Panel Survey.
The study was funded by a National Institutes of Health grant to Mr. Chee. All of his five associates have received a grant from the Food and Drug Administration to improve prescription of generic drugs.
SOURCE: Chee M. et al. JAMA Intern Med. 2018 Jan 16. doi: 10.1001/jamainternmed.2017.7849.
, according to an analysis of almost 20,000 OC-prescribing events.
Brand OCs with available generics represented 44% of expenditures for all OCs in both 2010 and 2014, while generics had 56% and 55% of spending in 2010 and 2014 and brand names without generics took 0% and 1%, respectively, Mark Chee and his associates wrote in a report published in JAMA Internal Medicine.
For the whole 4-year period, brand OCs accounted for 24% of all prescriptions and 42% of all expenditures for the 19,944 OC prescribing events included in the analysis of data from the Medical Expenditure Panel Survey.
The study was funded by a National Institutes of Health grant to Mr. Chee. All of his five associates have received a grant from the Food and Drug Administration to improve prescription of generic drugs.
SOURCE: Chee M. et al. JAMA Intern Med. 2018 Jan 16. doi: 10.1001/jamainternmed.2017.7849.
, according to an analysis of almost 20,000 OC-prescribing events.
Brand OCs with available generics represented 44% of expenditures for all OCs in both 2010 and 2014, while generics had 56% and 55% of spending in 2010 and 2014 and brand names without generics took 0% and 1%, respectively, Mark Chee and his associates wrote in a report published in JAMA Internal Medicine.
For the whole 4-year period, brand OCs accounted for 24% of all prescriptions and 42% of all expenditures for the 19,944 OC prescribing events included in the analysis of data from the Medical Expenditure Panel Survey.
The study was funded by a National Institutes of Health grant to Mr. Chee. All of his five associates have received a grant from the Food and Drug Administration to improve prescription of generic drugs.
SOURCE: Chee M. et al. JAMA Intern Med. 2018 Jan 16. doi: 10.1001/jamainternmed.2017.7849.
FROM JAMA INTERNAL MEDICINE
Breastfeeding lowers later diabetes risk in women
Breastfeeding may reduce a woman’s risk of developing diabetes, with a prospective cohort study showing a strong, inverse association between lactation duration and risk of diabetes.
In a report published in the Jan. 16 online edition of JAMA Internal Medicine, researchers analyzed data from the Coronary Artery Risk Development Study in Young Adults (CARDIA), which followed 1,238 women aged 18-30 for 30 years, with multiple assessments of glucose tolerance over the course of the study.
Women who breastfed for 6-12 months had a 48% reduction in the risk of diabetes (95% CI, 0.31-0.87), and those who breastfed for up to 6 months had a 25% lower risk (95% CI, 0.51-1.09), with the trend being significant.
In women with a history of gestational diabetes, those who did not breastfeed at all had a 2.08% higher excess risk of incident diabetes per year, compared with women who breastfed for at least 12 months. The increase in excess risk for the same comparison in women without a history of gestational diabetes was 0.48% per year.
Erica P. Gunderson, PhD, of Kaiser Permanente Northern California, Oakland, and her coauthors noted that previous meta-analyses of the effect of lactation on diabetes incidence or prevalence pointed to protective summary estimates of 9%-11% per year of lactation.
“Lactating women have lower circulating glucose in both fasting and post absorptive states, as well as lower insulin secretion, despite increased glucose production rates,” the authors wrote. “About 50 g of glucose per 24 hours is diverted into the mammary gland for milk synthesis via non–insulin mediated pathways.”
Studies in mice have also suggested that lactating animals have greater pancreatic beta-cell proliferation.
While the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists recommend breastfeeding for 1 year, only 55% of women in the United States are still breastfeeding at 6 months and 33% are still breastfeeding at 1 year after birth. Black women are also less likely to breastfeed, regardless of socioeconomic status or body size.
“Lactation is a natural biological process with the enormous potential to provide long-term benefits to maternal health, but has been underappreciated as a potential key strategy for early primary prevention of metabolic diseases in women across the childbearing years and beyond.”
The study and analyses were supported by the National Institute of Diabetes and Digestive and Kidney Diseases, and two authors declared funding from pharmaceutical companies.
SOURCE: JAMA Intern Med. 2016 Jan 16. doi: 10.1001/jamainternmed.2017.7978.
Breastfeeding may reduce a woman’s risk of developing diabetes, with a prospective cohort study showing a strong, inverse association between lactation duration and risk of diabetes.
In a report published in the Jan. 16 online edition of JAMA Internal Medicine, researchers analyzed data from the Coronary Artery Risk Development Study in Young Adults (CARDIA), which followed 1,238 women aged 18-30 for 30 years, with multiple assessments of glucose tolerance over the course of the study.
Women who breastfed for 6-12 months had a 48% reduction in the risk of diabetes (95% CI, 0.31-0.87), and those who breastfed for up to 6 months had a 25% lower risk (95% CI, 0.51-1.09), with the trend being significant.
In women with a history of gestational diabetes, those who did not breastfeed at all had a 2.08% higher excess risk of incident diabetes per year, compared with women who breastfed for at least 12 months. The increase in excess risk for the same comparison in women without a history of gestational diabetes was 0.48% per year.
Erica P. Gunderson, PhD, of Kaiser Permanente Northern California, Oakland, and her coauthors noted that previous meta-analyses of the effect of lactation on diabetes incidence or prevalence pointed to protective summary estimates of 9%-11% per year of lactation.
“Lactating women have lower circulating glucose in both fasting and post absorptive states, as well as lower insulin secretion, despite increased glucose production rates,” the authors wrote. “About 50 g of glucose per 24 hours is diverted into the mammary gland for milk synthesis via non–insulin mediated pathways.”
Studies in mice have also suggested that lactating animals have greater pancreatic beta-cell proliferation.
While the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists recommend breastfeeding for 1 year, only 55% of women in the United States are still breastfeeding at 6 months and 33% are still breastfeeding at 1 year after birth. Black women are also less likely to breastfeed, regardless of socioeconomic status or body size.
“Lactation is a natural biological process with the enormous potential to provide long-term benefits to maternal health, but has been underappreciated as a potential key strategy for early primary prevention of metabolic diseases in women across the childbearing years and beyond.”
The study and analyses were supported by the National Institute of Diabetes and Digestive and Kidney Diseases, and two authors declared funding from pharmaceutical companies.
SOURCE: JAMA Intern Med. 2016 Jan 16. doi: 10.1001/jamainternmed.2017.7978.
Breastfeeding may reduce a woman’s risk of developing diabetes, with a prospective cohort study showing a strong, inverse association between lactation duration and risk of diabetes.
In a report published in the Jan. 16 online edition of JAMA Internal Medicine, researchers analyzed data from the Coronary Artery Risk Development Study in Young Adults (CARDIA), which followed 1,238 women aged 18-30 for 30 years, with multiple assessments of glucose tolerance over the course of the study.
Women who breastfed for 6-12 months had a 48% reduction in the risk of diabetes (95% CI, 0.31-0.87), and those who breastfed for up to 6 months had a 25% lower risk (95% CI, 0.51-1.09), with the trend being significant.
In women with a history of gestational diabetes, those who did not breastfeed at all had a 2.08% higher excess risk of incident diabetes per year, compared with women who breastfed for at least 12 months. The increase in excess risk for the same comparison in women without a history of gestational diabetes was 0.48% per year.
Erica P. Gunderson, PhD, of Kaiser Permanente Northern California, Oakland, and her coauthors noted that previous meta-analyses of the effect of lactation on diabetes incidence or prevalence pointed to protective summary estimates of 9%-11% per year of lactation.
“Lactating women have lower circulating glucose in both fasting and post absorptive states, as well as lower insulin secretion, despite increased glucose production rates,” the authors wrote. “About 50 g of glucose per 24 hours is diverted into the mammary gland for milk synthesis via non–insulin mediated pathways.”
Studies in mice have also suggested that lactating animals have greater pancreatic beta-cell proliferation.
While the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists recommend breastfeeding for 1 year, only 55% of women in the United States are still breastfeeding at 6 months and 33% are still breastfeeding at 1 year after birth. Black women are also less likely to breastfeed, regardless of socioeconomic status or body size.
“Lactation is a natural biological process with the enormous potential to provide long-term benefits to maternal health, but has been underappreciated as a potential key strategy for early primary prevention of metabolic diseases in women across the childbearing years and beyond.”
The study and analyses were supported by the National Institute of Diabetes and Digestive and Kidney Diseases, and two authors declared funding from pharmaceutical companies.
SOURCE: JAMA Intern Med. 2016 Jan 16. doi: 10.1001/jamainternmed.2017.7978.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Duration of breastfeeding is inversely associated with risk of developing diabetes.
Major finding: Women who breastfeed for 12 months or more have a 47% lower risk of developing diabetes compared with women who do not breastfeed at all.
Data source: Analysis of data from the CARDIA population-based prospective cohort study in 1,238 women.
Disclosures: The study and analyses were supported by the National Institute of Diabetes and Digestive and Kidney Diseases, and two authors declared funding from pharmaceutical companies.
Source: JAMA Intern Med. 2016 Jan 16. doi: 10.1001/jamainternmed.2017.7978.
EC approves product to treat hemophilia A
The European Commission (EC) has granted marketing authorization for rurioctocog alfa pegol (Adynovi).
Rurioctocog alfa pegol (formerly BAX 855) is a pegylated, full-length, recombinant factor VIII product built on a previously licensed recombinant factor VIII product (Advate).
Rurioctocog alfa pegol is now EC-approved for on-demand and prophylactic use in patients age 12 and older with hemophilia A.
With the EC’s approval, Shire is authorized to market rurioctocog alfa pegol in all member states of the European Union as well as in Iceland, Liechtenstein, and Norway.
The marketing authorization for rurioctocog alfa pegol is based on outcomes from three phase 3 trials—a study of adolescents and adults, a trial of patients undergoing surgical procedures, and a study of pediatric patients.
Trial of adolescents/adults
This study included 137 patients, ages 12 to 58, with previously treated hemophilia A. They were assigned to either twice-weekly prophylaxis (40-50 IU/kg, n=120) or on-demand treatment (10-60 IU/kg, n=17) with rurioctocog alfa pegol. One hundred and twenty-six patients completed the study.
Patients who received prophylaxis had a 90% reduction in annualized bleeding rate (ABR) compared to those who received on-demand treatment. The median ABR was 1.9 in the prophylactic arm and 41.5 in the on-demand arm.
There were 7 adverse events (occurring in 6 patients) that were considered possibly related to rurioctocog alfa pegol. These included diarrhea, nausea, headache, and flushing.
These results were published in Blood in July 2015.
Perioperative study
This study included 15 patients with severe hemophilia A who were undergoing surgical procedures (11 of them major and 4 minor).
The patients received rurioctocog alfa pegol at varying doses and schedules, depending on each patient’s pharmacokinetic profile for major procedures or rurioctocog alfa pegol incremental recovery for minor procedures.
Intra-operative and peri-operative hemostatic efficacy of rurioctocog alfa pegol was deemed “excellent” for all 15 patients. The “excellent” rating meant that blood loss was less than or equal to that expected for the type of procedure performed in a non-hemophilic population.
Post-operatively (day 1 after the procedure), hemostatic efficacy was rated “good” for 1 procedure and “excellent” for the rest. The “good” rating meant that post-operative blood loss was up to 50% more than expected for the type of procedure performed in a non-hemophilic population.
There were no treatment-related adverse events or signs of immunogenicity in this trial.
Results were published in Haemophilia in June 2016.
Pediatric trial
This study included 66 patients, ages 1 to 11, who had previously treated hemophilia A. They received twice-weekly prophylaxis with rurioctocog alfa pegol (50 ± 10 IU/kg) for at least 6 months or 50 exposure days, whichever occurred last.
The median ABR was 2.0, and 38% of patients did not have any bleeding episodes.
None of the patients developed inhibitory antibodies, and there were no treatment-related adverse events.
Results from this trial were presented at the World Federation of Hemophilia 2016 World Congress in July 2016 and published in Haemophilia in November 2016. 
The European Commission (EC) has granted marketing authorization for rurioctocog alfa pegol (Adynovi).
Rurioctocog alfa pegol (formerly BAX 855) is a pegylated, full-length, recombinant factor VIII product built on a previously licensed recombinant factor VIII product (Advate).
Rurioctocog alfa pegol is now EC-approved for on-demand and prophylactic use in patients age 12 and older with hemophilia A.
With the EC’s approval, Shire is authorized to market rurioctocog alfa pegol in all member states of the European Union as well as in Iceland, Liechtenstein, and Norway.
The marketing authorization for rurioctocog alfa pegol is based on outcomes from three phase 3 trials—a study of adolescents and adults, a trial of patients undergoing surgical procedures, and a study of pediatric patients.
Trial of adolescents/adults
This study included 137 patients, ages 12 to 58, with previously treated hemophilia A. They were assigned to either twice-weekly prophylaxis (40-50 IU/kg, n=120) or on-demand treatment (10-60 IU/kg, n=17) with rurioctocog alfa pegol. One hundred and twenty-six patients completed the study.
Patients who received prophylaxis had a 90% reduction in annualized bleeding rate (ABR) compared to those who received on-demand treatment. The median ABR was 1.9 in the prophylactic arm and 41.5 in the on-demand arm.
There were 7 adverse events (occurring in 6 patients) that were considered possibly related to rurioctocog alfa pegol. These included diarrhea, nausea, headache, and flushing.
These results were published in Blood in July 2015.
Perioperative study
This study included 15 patients with severe hemophilia A who were undergoing surgical procedures (11 of them major and 4 minor).
The patients received rurioctocog alfa pegol at varying doses and schedules, depending on each patient’s pharmacokinetic profile for major procedures or rurioctocog alfa pegol incremental recovery for minor procedures.
Intra-operative and peri-operative hemostatic efficacy of rurioctocog alfa pegol was deemed “excellent” for all 15 patients. The “excellent” rating meant that blood loss was less than or equal to that expected for the type of procedure performed in a non-hemophilic population.
Post-operatively (day 1 after the procedure), hemostatic efficacy was rated “good” for 1 procedure and “excellent” for the rest. The “good” rating meant that post-operative blood loss was up to 50% more than expected for the type of procedure performed in a non-hemophilic population.
There were no treatment-related adverse events or signs of immunogenicity in this trial.
Results were published in Haemophilia in June 2016.
Pediatric trial
This study included 66 patients, ages 1 to 11, who had previously treated hemophilia A. They received twice-weekly prophylaxis with rurioctocog alfa pegol (50 ± 10 IU/kg) for at least 6 months or 50 exposure days, whichever occurred last.
The median ABR was 2.0, and 38% of patients did not have any bleeding episodes.
None of the patients developed inhibitory antibodies, and there were no treatment-related adverse events.
Results from this trial were presented at the World Federation of Hemophilia 2016 World Congress in July 2016 and published in Haemophilia in November 2016.
The European Commission (EC) has granted marketing authorization for rurioctocog alfa pegol (Adynovi).
Rurioctocog alfa pegol (formerly BAX 855) is a pegylated, full-length, recombinant factor VIII product built on a previously licensed recombinant factor VIII product (Advate).
Rurioctocog alfa pegol is now EC-approved for on-demand and prophylactic use in patients age 12 and older with hemophilia A.
With the EC’s approval, Shire is authorized to market rurioctocog alfa pegol in all member states of the European Union as well as in Iceland, Liechtenstein, and Norway.
The marketing authorization for rurioctocog alfa pegol is based on outcomes from three phase 3 trials—a study of adolescents and adults, a trial of patients undergoing surgical procedures, and a study of pediatric patients.
Trial of adolescents/adults
This study included 137 patients, ages 12 to 58, with previously treated hemophilia A. They were assigned to either twice-weekly prophylaxis (40-50 IU/kg, n=120) or on-demand treatment (10-60 IU/kg, n=17) with rurioctocog alfa pegol. One hundred and twenty-six patients completed the study.
Patients who received prophylaxis had a 90% reduction in annualized bleeding rate (ABR) compared to those who received on-demand treatment. The median ABR was 1.9 in the prophylactic arm and 41.5 in the on-demand arm.
There were 7 adverse events (occurring in 6 patients) that were considered possibly related to rurioctocog alfa pegol. These included diarrhea, nausea, headache, and flushing.
These results were published in Blood in July 2015.
Perioperative study
This study included 15 patients with severe hemophilia A who were undergoing surgical procedures (11 of them major and 4 minor).
The patients received rurioctocog alfa pegol at varying doses and schedules, depending on each patient’s pharmacokinetic profile for major procedures or rurioctocog alfa pegol incremental recovery for minor procedures.
Intra-operative and peri-operative hemostatic efficacy of rurioctocog alfa pegol was deemed “excellent” for all 15 patients. The “excellent” rating meant that blood loss was less than or equal to that expected for the type of procedure performed in a non-hemophilic population.
Post-operatively (day 1 after the procedure), hemostatic efficacy was rated “good” for 1 procedure and “excellent” for the rest. The “good” rating meant that post-operative blood loss was up to 50% more than expected for the type of procedure performed in a non-hemophilic population.
There were no treatment-related adverse events or signs of immunogenicity in this trial.
Results were published in Haemophilia in June 2016.
Pediatric trial
This study included 66 patients, ages 1 to 11, who had previously treated hemophilia A. They received twice-weekly prophylaxis with rurioctocog alfa pegol (50 ± 10 IU/kg) for at least 6 months or 50 exposure days, whichever occurred last.
The median ABR was 2.0, and 38% of patients did not have any bleeding episodes.
None of the patients developed inhibitory antibodies, and there were no treatment-related adverse events.
Results from this trial were presented at the World Federation of Hemophilia 2016 World Congress in July 2016 and published in Haemophilia in November 2016.
FDA aims to improve access to clinical trial info
The US Food and Drug Administration (FDA) says it is taking new steps to improve public access to clinical trial information.
The agency is launching a pilot program to evaluate whether releasing portions of clinical study reports (CSRs) will improve public access to drug approval information.
The FDA is also planning to add NCT numbers to FDA materials to make it easier to match listings on ClinicalTrials.gov to FDA communications.
FDA Commissioner Scott Gottlieb, MD, noted that, when a drug is approved, the FDA releases certain information the agency used when reviewing the new drug application (NDA).
This includes summaries written by medical reviewers that capture their assessment of the data, the proposed labeling or other requirements, and other data supporting safe and effective use. This information is included in the drug approvals database, Drugs@FDA.
Dr Gottlieb said these summaries are packaged in a format that can sometimes make it difficult for external audiences to extract all of the detailed clinical evidence that supported the FDA’s approval decisions.
Therefore, the agency is launching a pilot program to evaluate whether disclosing certain information included in CSRs will provide stakeholders with more details on the clinical evidence supporting a drug application and more transparency into the FDA’s decision-making process.
The FDA plans to select up to 9 recently approved NDAs whose sponsors will provide portions of CSRs from trials that were submitted to the FDA.
The CSRs will be posted on a new web page on the FDA’s website that describes the pilot program, in addition to appearing on Drugs@FDA along with the drug’s approval information.
The pilot will begin this month. The FDA will soon begin contacting sponsors to see if they are interested in participating in the pilot.
The agency will provide participating sponsors with additional information to ensure their understanding of the process. The FDA also promises to protect patient privacy, trade secret, and confidential commercial information in the CSRs it releases.
Once the pilot program is complete, the FDA will seek public feedback through a Federal Register notice and docket for public comments.
To augment the CSR pilot, the FDA is adding NCT numbers to materials for future drug approvals.
The agency believes this will make it easier to associate listings on ClinicalTrials.gov with FDA communications about specific drugs, including product labeling and advisory committee meeting materials.
The US Food and Drug Administration (FDA) says it is taking new steps to improve public access to clinical trial information.
The agency is launching a pilot program to evaluate whether releasing portions of clinical study reports (CSRs) will improve public access to drug approval information.
The FDA is also planning to add NCT numbers to FDA materials to make it easier to match listings on ClinicalTrials.gov to FDA communications.
FDA Commissioner Scott Gottlieb, MD, noted that, when a drug is approved, the FDA releases certain information the agency used when reviewing the new drug application (NDA).
This includes summaries written by medical reviewers that capture their assessment of the data, the proposed labeling or other requirements, and other data supporting safe and effective use. This information is included in the drug approvals database, Drugs@FDA.
Dr Gottlieb said these summaries are packaged in a format that can sometimes make it difficult for external audiences to extract all of the detailed clinical evidence that supported the FDA’s approval decisions.
Therefore, the agency is launching a pilot program to evaluate whether disclosing certain information included in CSRs will provide stakeholders with more details on the clinical evidence supporting a drug application and more transparency into the FDA’s decision-making process.
The FDA plans to select up to 9 recently approved NDAs whose sponsors will provide portions of CSRs from trials that were submitted to the FDA.
The CSRs will be posted on a new web page on the FDA’s website that describes the pilot program, in addition to appearing on Drugs@FDA along with the drug’s approval information.
The pilot will begin this month. The FDA will soon begin contacting sponsors to see if they are interested in participating in the pilot.
The agency will provide participating sponsors with additional information to ensure their understanding of the process. The FDA also promises to protect patient privacy, trade secret, and confidential commercial information in the CSRs it releases.
Once the pilot program is complete, the FDA will seek public feedback through a Federal Register notice and docket for public comments.
To augment the CSR pilot, the FDA is adding NCT numbers to materials for future drug approvals.
The agency believes this will make it easier to associate listings on ClinicalTrials.gov with FDA communications about specific drugs, including product labeling and advisory committee meeting materials.
The US Food and Drug Administration (FDA) says it is taking new steps to improve public access to clinical trial information.
The agency is launching a pilot program to evaluate whether releasing portions of clinical study reports (CSRs) will improve public access to drug approval information.
The FDA is also planning to add NCT numbers to FDA materials to make it easier to match listings on ClinicalTrials.gov to FDA communications.
FDA Commissioner Scott Gottlieb, MD, noted that, when a drug is approved, the FDA releases certain information the agency used when reviewing the new drug application (NDA).
This includes summaries written by medical reviewers that capture their assessment of the data, the proposed labeling or other requirements, and other data supporting safe and effective use. This information is included in the drug approvals database, Drugs@FDA.
Dr Gottlieb said these summaries are packaged in a format that can sometimes make it difficult for external audiences to extract all of the detailed clinical evidence that supported the FDA’s approval decisions.
Therefore, the agency is launching a pilot program to evaluate whether disclosing certain information included in CSRs will provide stakeholders with more details on the clinical evidence supporting a drug application and more transparency into the FDA’s decision-making process.
The FDA plans to select up to 9 recently approved NDAs whose sponsors will provide portions of CSRs from trials that were submitted to the FDA.
The CSRs will be posted on a new web page on the FDA’s website that describes the pilot program, in addition to appearing on Drugs@FDA along with the drug’s approval information.
The pilot will begin this month. The FDA will soon begin contacting sponsors to see if they are interested in participating in the pilot.
The agency will provide participating sponsors with additional information to ensure their understanding of the process. The FDA also promises to protect patient privacy, trade secret, and confidential commercial information in the CSRs it releases.
Once the pilot program is complete, the FDA will seek public feedback through a Federal Register notice and docket for public comments.
To augment the CSR pilot, the FDA is adding NCT numbers to materials for future drug approvals.
The agency believes this will make it easier to associate listings on ClinicalTrials.gov with FDA communications about specific drugs, including product labeling and advisory committee meeting materials.
Drug’s label updated to include risk of allergic reactions
The US Food and Drug Administration (FDA) and Tesaro, Inc., have updated the prescribing information for Varubi® (rolapitant) injectable emulsion to include a new warning about the risk of allergic reactions.
Varubi injectable emulsion is a substance P/neurokinin receptor antagonist approved to prevent delayed nausea and vomiting associated with chemotherapy in adults.
Since Varubi injectable emulsion gained FDA approval, there have been reports of anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions to the drug, some of which required hospitalization.
Now, the labeling for Varubi injectable emulsion has been changed to include information about these events. The changes include modifications to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS, and ADVERSE REACTIONS sections of the label.
Since Varubi injectable emulsion was introduced to the US market in late November 2017, at least 7000 doses of the drug have been administered to patients receiving emetogenic chemotherapy in the US, according to Tesaro.
Anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions have occurred during or soon after the infusion of Varubi. Most reactions have occurred within the first few minutes of administration.
The FDA has advised that patients who are hypersensitive to any component of Varubi injectable emulsion (including soybean oil) do not receive the drug. And patients with known allergies to legumes or other related allergens should be monitored closely.
The FDA said healthcare professionals should be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving Varubi injectable emulsion, both during administration and afterward.
Symptoms of anaphylaxis can include wheezing, difficulty breathing, swelling of the face or throat, hives, flushing, itching, abdominal cramping, abdominal pain, vomiting, back pain, chest pain, hypotension, and shock.
If anaphylaxis or any other serious hypersensitivity/infusion reaction occurs, Varubi injectable emulsion should be stopped immediately and permanently. The patient should receive appropriate medical management, including epinephrine and/or antihistamines.
To ensure patients and healthcare professionals are aware of the label update to Varubi injectable emulsion, Tesaro has issued a Dear Healthcare Professional letter. In addition, the updated prescribing information has been posted on the Varubi website.
For any questions about the use of Varubi injectable emulsion or to report adverse events related to the drug, contact Tesaro’s medical information department at 1-844-4-TESARO (1-844-483-7276).
Adverse events related to Varubi should also be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
The US Food and Drug Administration (FDA) and Tesaro, Inc., have updated the prescribing information for Varubi® (rolapitant) injectable emulsion to include a new warning about the risk of allergic reactions.
Varubi injectable emulsion is a substance P/neurokinin receptor antagonist approved to prevent delayed nausea and vomiting associated with chemotherapy in adults.
Since Varubi injectable emulsion gained FDA approval, there have been reports of anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions to the drug, some of which required hospitalization.
Now, the labeling for Varubi injectable emulsion has been changed to include information about these events. The changes include modifications to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS, and ADVERSE REACTIONS sections of the label.
Since Varubi injectable emulsion was introduced to the US market in late November 2017, at least 7000 doses of the drug have been administered to patients receiving emetogenic chemotherapy in the US, according to Tesaro.
Anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions have occurred during or soon after the infusion of Varubi. Most reactions have occurred within the first few minutes of administration.
The FDA has advised that patients who are hypersensitive to any component of Varubi injectable emulsion (including soybean oil) do not receive the drug. And patients with known allergies to legumes or other related allergens should be monitored closely.
The FDA said healthcare professionals should be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving Varubi injectable emulsion, both during administration and afterward.
Symptoms of anaphylaxis can include wheezing, difficulty breathing, swelling of the face or throat, hives, flushing, itching, abdominal cramping, abdominal pain, vomiting, back pain, chest pain, hypotension, and shock.
If anaphylaxis or any other serious hypersensitivity/infusion reaction occurs, Varubi injectable emulsion should be stopped immediately and permanently. The patient should receive appropriate medical management, including epinephrine and/or antihistamines.
To ensure patients and healthcare professionals are aware of the label update to Varubi injectable emulsion, Tesaro has issued a Dear Healthcare Professional letter. In addition, the updated prescribing information has been posted on the Varubi website.
For any questions about the use of Varubi injectable emulsion or to report adverse events related to the drug, contact Tesaro’s medical information department at 1-844-4-TESARO (1-844-483-7276).
Adverse events related to Varubi should also be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
The US Food and Drug Administration (FDA) and Tesaro, Inc., have updated the prescribing information for Varubi® (rolapitant) injectable emulsion to include a new warning about the risk of allergic reactions.
Varubi injectable emulsion is a substance P/neurokinin receptor antagonist approved to prevent delayed nausea and vomiting associated with chemotherapy in adults.
Since Varubi injectable emulsion gained FDA approval, there have been reports of anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions to the drug, some of which required hospitalization.
Now, the labeling for Varubi injectable emulsion has been changed to include information about these events. The changes include modifications to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS, and ADVERSE REACTIONS sections of the label.
Since Varubi injectable emulsion was introduced to the US market in late November 2017, at least 7000 doses of the drug have been administered to patients receiving emetogenic chemotherapy in the US, according to Tesaro.
Anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions have occurred during or soon after the infusion of Varubi. Most reactions have occurred within the first few minutes of administration.
The FDA has advised that patients who are hypersensitive to any component of Varubi injectable emulsion (including soybean oil) do not receive the drug. And patients with known allergies to legumes or other related allergens should be monitored closely.
The FDA said healthcare professionals should be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving Varubi injectable emulsion, both during administration and afterward.
Symptoms of anaphylaxis can include wheezing, difficulty breathing, swelling of the face or throat, hives, flushing, itching, abdominal cramping, abdominal pain, vomiting, back pain, chest pain, hypotension, and shock.
If anaphylaxis or any other serious hypersensitivity/infusion reaction occurs, Varubi injectable emulsion should be stopped immediately and permanently. The patient should receive appropriate medical management, including epinephrine and/or antihistamines.
To ensure patients and healthcare professionals are aware of the label update to Varubi injectable emulsion, Tesaro has issued a Dear Healthcare Professional letter. In addition, the updated prescribing information has been posted on the Varubi website.
For any questions about the use of Varubi injectable emulsion or to report adverse events related to the drug, contact Tesaro’s medical information department at 1-844-4-TESARO (1-844-483-7276).
Adverse events related to Varubi should also be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Nominations now open for the 2018 Surgical Volunteerism and Humanitarian Awards
The American College of Surgeons (ACS), in association with Pfizer, Inc., has begun accepting nominations for the 2018 Surgical Volunteerism and Humanitarian Awards. These annual awards recognize surgeons who have made significant contributions to communities in need of surgical aid, be that through organized volunteer activities or through the dedication of a significant portion of their surgical career to the underserved or a retirement characterized by surgical outreach.
Submit nominations today at www.facs.org/ogb/award-winners/nominations. All nominations must be received by February 28, 2018. For more information, contact [email protected] or visit the awards web page.
The American College of Surgeons (ACS), in association with Pfizer, Inc., has begun accepting nominations for the 2018 Surgical Volunteerism and Humanitarian Awards. These annual awards recognize surgeons who have made significant contributions to communities in need of surgical aid, be that through organized volunteer activities or through the dedication of a significant portion of their surgical career to the underserved or a retirement characterized by surgical outreach.
Submit nominations today at www.facs.org/ogb/award-winners/nominations. All nominations must be received by February 28, 2018. For more information, contact [email protected] or visit the awards web page.
The American College of Surgeons (ACS), in association with Pfizer, Inc., has begun accepting nominations for the 2018 Surgical Volunteerism and Humanitarian Awards. These annual awards recognize surgeons who have made significant contributions to communities in need of surgical aid, be that through organized volunteer activities or through the dedication of a significant portion of their surgical career to the underserved or a retirement characterized by surgical outreach.
Submit nominations today at www.facs.org/ogb/award-winners/nominations. All nominations must be received by February 28, 2018. For more information, contact [email protected] or visit the awards web page.
Apply now for the ACS Clinical Scholars in Residence positions
The American College of Surgeons (ACS) is now accepting applications for the 2019–2021 Clinical Scholar in Residence positions. Applications are due April 1.
The ACS Clinical Scholars in Residence Program is a two-year on-site fellowship in surgical outcomes research, health services research, and health care policy. It was initiated in 2005 to advance the College’s quality improvement initiatives and to offer opportunities for residents to work on ACS Quality Programs. More specifically, ACS Clinical Scholars in Residence perform research relevant to ongoing projects in the ACS Division of Research and Optimal Patient Care.
About the program
The primary objective of the fellowship is to address issues in health care quality, health policy, and patient safety, with the goal of helping the ACS Clinical Scholar in Residence prepare for a research career in academic surgery. The ACS Clinical Scholars in Residence have worked on projects and research using data from the ACS National Surgical Quality Improvement Program, the National Cancer Database, the National Trauma Data Bank®, the Surgeon Specific Registry, and the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program and have been involved in guideline development and accreditation programs. Scholars are assigned to the appropriate group within the ACS based on their interests and the College’s needs.
In addition, participants earn a master’s degree in health services and outcomes research or health care quality and patient safety during their two years at the ACS headquarters in Chicago, IL. The goal of this aspect of the program is to educate clinicians to become effective researchers in health care services and outcomes. The health services and outcomes research curriculum focuses on these issues within institutional and health care delivery systems, as well as in the external environment that shapes health policy centered on quality and safety issues.
The program takes approximately two years to complete. All coursework is done at Northwestern University’s downtown Chicago campus, one block from the ACS headquarters. The ACS also offers a variety of educational programs from which the Clinical Scholars may benefit, including the Outcomes Research Course and the Clinical Trials Course.
The ACS assigns internal mentors to meet regularly with each ACS Clinical Scholar in Residence. Scholars also have opportunities to interact with various surgeons who are affiliated with the ACS and the Division of Research and Optimal Patient Care. Mentorship is one of the most important aspects of this fellowship. Guidance and interaction with multiple individuals from diverse backgrounds will provide the best opportunity for success. In addition, a core of ACS staff statisticians and project analysts serve as invaluable resources to the ACS Clinical Scholars in Residence.
Past successes
Since its inception, surgical residents from throughout the U.S., including California, Colorado, Connecticut, Illinois, Kansas, Louisiana, Michigan, and Ohio, have participated in the ACS Clinical Scholars in Residence program. These individuals report excellent, productive experiences that have been useful in launching their careers in the field of academic surgery. In all, 16 scholars have completed the program and five scholars are currently participating. The ACS Clinical Scholars in Residence have demonstrated great dedication to outcomes research and the improvement of the quality of surgical care.
The ACS Clinical Scholars in Residence have presented their findings at national meetings and in high-impact, peer-reviewed publications, in addition to having contributed a great deal to the ACS Quality Programs. Furthermore, scholars have gone on to gain prestigious fellowships in several fields, including surgical oncology and pediatric surgery.
Apply now
The 2019–2021 scholars will begin their work July 1, 2019. Applications for these positions are due by April 1, 2018. Applicants are required to have funding from their institution or other grant mechanism.
For more information about the program and the application requirements, go to facs.org/clinicalscholars, or send an e-mail to [email protected].
The American College of Surgeons (ACS) is now accepting applications for the 2019–2021 Clinical Scholar in Residence positions. Applications are due April 1.
The ACS Clinical Scholars in Residence Program is a two-year on-site fellowship in surgical outcomes research, health services research, and health care policy. It was initiated in 2005 to advance the College’s quality improvement initiatives and to offer opportunities for residents to work on ACS Quality Programs. More specifically, ACS Clinical Scholars in Residence perform research relevant to ongoing projects in the ACS Division of Research and Optimal Patient Care.
About the program
The primary objective of the fellowship is to address issues in health care quality, health policy, and patient safety, with the goal of helping the ACS Clinical Scholar in Residence prepare for a research career in academic surgery. The ACS Clinical Scholars in Residence have worked on projects and research using data from the ACS National Surgical Quality Improvement Program, the National Cancer Database, the National Trauma Data Bank®, the Surgeon Specific Registry, and the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program and have been involved in guideline development and accreditation programs. Scholars are assigned to the appropriate group within the ACS based on their interests and the College’s needs.
In addition, participants earn a master’s degree in health services and outcomes research or health care quality and patient safety during their two years at the ACS headquarters in Chicago, IL. The goal of this aspect of the program is to educate clinicians to become effective researchers in health care services and outcomes. The health services and outcomes research curriculum focuses on these issues within institutional and health care delivery systems, as well as in the external environment that shapes health policy centered on quality and safety issues.
The program takes approximately two years to complete. All coursework is done at Northwestern University’s downtown Chicago campus, one block from the ACS headquarters. The ACS also offers a variety of educational programs from which the Clinical Scholars may benefit, including the Outcomes Research Course and the Clinical Trials Course.
The ACS assigns internal mentors to meet regularly with each ACS Clinical Scholar in Residence. Scholars also have opportunities to interact with various surgeons who are affiliated with the ACS and the Division of Research and Optimal Patient Care. Mentorship is one of the most important aspects of this fellowship. Guidance and interaction with multiple individuals from diverse backgrounds will provide the best opportunity for success. In addition, a core of ACS staff statisticians and project analysts serve as invaluable resources to the ACS Clinical Scholars in Residence.
Past successes
Since its inception, surgical residents from throughout the U.S., including California, Colorado, Connecticut, Illinois, Kansas, Louisiana, Michigan, and Ohio, have participated in the ACS Clinical Scholars in Residence program. These individuals report excellent, productive experiences that have been useful in launching their careers in the field of academic surgery. In all, 16 scholars have completed the program and five scholars are currently participating. The ACS Clinical Scholars in Residence have demonstrated great dedication to outcomes research and the improvement of the quality of surgical care.
The ACS Clinical Scholars in Residence have presented their findings at national meetings and in high-impact, peer-reviewed publications, in addition to having contributed a great deal to the ACS Quality Programs. Furthermore, scholars have gone on to gain prestigious fellowships in several fields, including surgical oncology and pediatric surgery.
Apply now
The 2019–2021 scholars will begin their work July 1, 2019. Applications for these positions are due by April 1, 2018. Applicants are required to have funding from their institution or other grant mechanism.
For more information about the program and the application requirements, go to facs.org/clinicalscholars, or send an e-mail to [email protected].
The American College of Surgeons (ACS) is now accepting applications for the 2019–2021 Clinical Scholar in Residence positions. Applications are due April 1.
The ACS Clinical Scholars in Residence Program is a two-year on-site fellowship in surgical outcomes research, health services research, and health care policy. It was initiated in 2005 to advance the College’s quality improvement initiatives and to offer opportunities for residents to work on ACS Quality Programs. More specifically, ACS Clinical Scholars in Residence perform research relevant to ongoing projects in the ACS Division of Research and Optimal Patient Care.
About the program
The primary objective of the fellowship is to address issues in health care quality, health policy, and patient safety, with the goal of helping the ACS Clinical Scholar in Residence prepare for a research career in academic surgery. The ACS Clinical Scholars in Residence have worked on projects and research using data from the ACS National Surgical Quality Improvement Program, the National Cancer Database, the National Trauma Data Bank®, the Surgeon Specific Registry, and the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program and have been involved in guideline development and accreditation programs. Scholars are assigned to the appropriate group within the ACS based on their interests and the College’s needs.
In addition, participants earn a master’s degree in health services and outcomes research or health care quality and patient safety during their two years at the ACS headquarters in Chicago, IL. The goal of this aspect of the program is to educate clinicians to become effective researchers in health care services and outcomes. The health services and outcomes research curriculum focuses on these issues within institutional and health care delivery systems, as well as in the external environment that shapes health policy centered on quality and safety issues.
The program takes approximately two years to complete. All coursework is done at Northwestern University’s downtown Chicago campus, one block from the ACS headquarters. The ACS also offers a variety of educational programs from which the Clinical Scholars may benefit, including the Outcomes Research Course and the Clinical Trials Course.
The ACS assigns internal mentors to meet regularly with each ACS Clinical Scholar in Residence. Scholars also have opportunities to interact with various surgeons who are affiliated with the ACS and the Division of Research and Optimal Patient Care. Mentorship is one of the most important aspects of this fellowship. Guidance and interaction with multiple individuals from diverse backgrounds will provide the best opportunity for success. In addition, a core of ACS staff statisticians and project analysts serve as invaluable resources to the ACS Clinical Scholars in Residence.
Past successes
Since its inception, surgical residents from throughout the U.S., including California, Colorado, Connecticut, Illinois, Kansas, Louisiana, Michigan, and Ohio, have participated in the ACS Clinical Scholars in Residence program. These individuals report excellent, productive experiences that have been useful in launching their careers in the field of academic surgery. In all, 16 scholars have completed the program and five scholars are currently participating. The ACS Clinical Scholars in Residence have demonstrated great dedication to outcomes research and the improvement of the quality of surgical care.
The ACS Clinical Scholars in Residence have presented their findings at national meetings and in high-impact, peer-reviewed publications, in addition to having contributed a great deal to the ACS Quality Programs. Furthermore, scholars have gone on to gain prestigious fellowships in several fields, including surgical oncology and pediatric surgery.
Apply now
The 2019–2021 scholars will begin their work July 1, 2019. Applications for these positions are due by April 1, 2018. Applicants are required to have funding from their institution or other grant mechanism.
For more information about the program and the application requirements, go to facs.org/clinicalscholars, or send an e-mail to [email protected].
ACSPA-SurgeonsPAC year-end update
The American College of Surgeons Professional Association (ACSPA) and members of its political action committee (ACSPA-SurgeonsPAC) provide nonpartisan financial support to federal lawmakers and individuals seeking office who share surgery’s perspective on health care policy issues and are well-positioned to advocate for surgery’s legislative goals. As of press time, the ACSPA-SurgeonsPAC raised more than $500,000 from more than 1,200 ACSPA members and staff, and disbursed more than $380,000 to more than 100 congressional candidates, leadership PACs, and political campaign committees.
Following are SurgeonsPAC fundraising and disbursement highlights:
• Willens Society ($25,000 or more over 10 years): 12
• Elite Donors ($2,500–$5,000): 23
• High Donors ($500–$2,499): 372
• General Donors ($100–$499): 669
• Top ACS leadership groups with 100 percent participation: Regents and Officers, Health Policy Advisory Council, Health Policy and Advocacy Group, and SurgeonsPAC Board of Directors
• Top five specialties: General, pediatric, vascular, colorectal, and plastic and reconstructive surgery
• Top states: Texas, California, New York, Ohio, and Pennsylvania
• Contributions disbursed in line with Congressional party ratios—58 percent to Republicans and 42 percent to Democrats
• Attended/hosted more than 200 health care industry events
• Organized eight physician community events for key surgical champions in Congress
• Facilitated more than 30 in-district check deliveries
• Supported 12 physician candidates
In addition, SurgeonsPAC co-hosted the eighth annual Specialty Physician and Dentist Candidate Workshop and 10th annual Medical and Dental PAC Forum.
To learn more about SurgeonsPAC fundraising and disbursement activities, contact SurgeonsPAC staff at [email protected] or 202-672-1520.
Note
Contributions to ACSPA-SurgeonsPAC are not deductible as charitable contributions for federal income tax purposes. Contributions are voluntary, and all members of the ACSPA have the right to refuse to contribute without reprisal. Federal Law prohibits ACSPA-SurgeonsPAC from accepting contributions from foreign nationals. By law, if your contributions are made using a personal check or credit card, ACSPA-SurgeonsPAC may only use your contribution to support candidates in federal elections. All corporate contributions to ACSPA-SurgeonsPAC will be used for educational and administrative fees of ACSPA, and other activities permissible under federal law. Federal law requires ACSPA-SurgeonsPAC to use its best efforts to collect and report the name, mailing address, occupation, and the name of the employer of individuals who contribute more than $200 in a calendar year. ACSPA-SurgeonsPAC is a program of the ACSPA which is exempt from federal income tax under section 501(c)(6) of the Internal Revenue Service.
The American College of Surgeons Professional Association (ACSPA) and members of its political action committee (ACSPA-SurgeonsPAC) provide nonpartisan financial support to federal lawmakers and individuals seeking office who share surgery’s perspective on health care policy issues and are well-positioned to advocate for surgery’s legislative goals. As of press time, the ACSPA-SurgeonsPAC raised more than $500,000 from more than 1,200 ACSPA members and staff, and disbursed more than $380,000 to more than 100 congressional candidates, leadership PACs, and political campaign committees.
Following are SurgeonsPAC fundraising and disbursement highlights:
• Willens Society ($25,000 or more over 10 years): 12
• Elite Donors ($2,500–$5,000): 23
• High Donors ($500–$2,499): 372
• General Donors ($100–$499): 669
• Top ACS leadership groups with 100 percent participation: Regents and Officers, Health Policy Advisory Council, Health Policy and Advocacy Group, and SurgeonsPAC Board of Directors
• Top five specialties: General, pediatric, vascular, colorectal, and plastic and reconstructive surgery
• Top states: Texas, California, New York, Ohio, and Pennsylvania
• Contributions disbursed in line with Congressional party ratios—58 percent to Republicans and 42 percent to Democrats
• Attended/hosted more than 200 health care industry events
• Organized eight physician community events for key surgical champions in Congress
• Facilitated more than 30 in-district check deliveries
• Supported 12 physician candidates
In addition, SurgeonsPAC co-hosted the eighth annual Specialty Physician and Dentist Candidate Workshop and 10th annual Medical and Dental PAC Forum.
To learn more about SurgeonsPAC fundraising and disbursement activities, contact SurgeonsPAC staff at [email protected] or 202-672-1520.
Note
Contributions to ACSPA-SurgeonsPAC are not deductible as charitable contributions for federal income tax purposes. Contributions are voluntary, and all members of the ACSPA have the right to refuse to contribute without reprisal. Federal Law prohibits ACSPA-SurgeonsPAC from accepting contributions from foreign nationals. By law, if your contributions are made using a personal check or credit card, ACSPA-SurgeonsPAC may only use your contribution to support candidates in federal elections. All corporate contributions to ACSPA-SurgeonsPAC will be used for educational and administrative fees of ACSPA, and other activities permissible under federal law. Federal law requires ACSPA-SurgeonsPAC to use its best efforts to collect and report the name, mailing address, occupation, and the name of the employer of individuals who contribute more than $200 in a calendar year. ACSPA-SurgeonsPAC is a program of the ACSPA which is exempt from federal income tax under section 501(c)(6) of the Internal Revenue Service.
The American College of Surgeons Professional Association (ACSPA) and members of its political action committee (ACSPA-SurgeonsPAC) provide nonpartisan financial support to federal lawmakers and individuals seeking office who share surgery’s perspective on health care policy issues and are well-positioned to advocate for surgery’s legislative goals. As of press time, the ACSPA-SurgeonsPAC raised more than $500,000 from more than 1,200 ACSPA members and staff, and disbursed more than $380,000 to more than 100 congressional candidates, leadership PACs, and political campaign committees.
Following are SurgeonsPAC fundraising and disbursement highlights:
• Willens Society ($25,000 or more over 10 years): 12
• Elite Donors ($2,500–$5,000): 23
• High Donors ($500–$2,499): 372
• General Donors ($100–$499): 669
• Top ACS leadership groups with 100 percent participation: Regents and Officers, Health Policy Advisory Council, Health Policy and Advocacy Group, and SurgeonsPAC Board of Directors
• Top five specialties: General, pediatric, vascular, colorectal, and plastic and reconstructive surgery
• Top states: Texas, California, New York, Ohio, and Pennsylvania
• Contributions disbursed in line with Congressional party ratios—58 percent to Republicans and 42 percent to Democrats
• Attended/hosted more than 200 health care industry events
• Organized eight physician community events for key surgical champions in Congress
• Facilitated more than 30 in-district check deliveries
• Supported 12 physician candidates
In addition, SurgeonsPAC co-hosted the eighth annual Specialty Physician and Dentist Candidate Workshop and 10th annual Medical and Dental PAC Forum.
To learn more about SurgeonsPAC fundraising and disbursement activities, contact SurgeonsPAC staff at [email protected] or 202-672-1520.
Note
Contributions to ACSPA-SurgeonsPAC are not deductible as charitable contributions for federal income tax purposes. Contributions are voluntary, and all members of the ACSPA have the right to refuse to contribute without reprisal. Federal Law prohibits ACSPA-SurgeonsPAC from accepting contributions from foreign nationals. By law, if your contributions are made using a personal check or credit card, ACSPA-SurgeonsPAC may only use your contribution to support candidates in federal elections. All corporate contributions to ACSPA-SurgeonsPAC will be used for educational and administrative fees of ACSPA, and other activities permissible under federal law. Federal law requires ACSPA-SurgeonsPAC to use its best efforts to collect and report the name, mailing address, occupation, and the name of the employer of individuals who contribute more than $200 in a calendar year. ACSPA-SurgeonsPAC is a program of the ACSPA which is exempt from federal income tax under section 501(c)(6) of the Internal Revenue Service.
Nominations for Board of Regents, Officers-Elect due February 23
The American College of Surgeons (ACS) 2018 Nominating Committee of the Fellows (NCF) and the Nominating Committee of the Board of Governors (NCBG) will be selecting nominees for leadership positions in the College.
The 2018 NCF will select nominees for the three Officer-Elect positions of the ACS:
• President-Elect
• First Vice-President-Elect
• Second Vice-President-Elect
The 2018 NCBG will select nominees for pending vacancies on the Board of Regents to be filled at Clinical Congress 2018. Nominations are open to surgeons of all specialties, but particular consideration will be given this nomination cycle to those in the following specialties:
• Burn and critical care surgery
• Gastrointestinal surgery
• General surgery
• Surgical oncology
• Transplantation
• Trauma
• Vascular surgery
For information only, the members of the Board of Regents who will be considered for reelection in 2018 are (all MD, FACS) John L. D. Atkinson, James C. Denneny III, Timothy J. Eberlein, Henri R. Ford, Enrique Hernandez, L. Scott Levin, Linda Phillips, Anton A. Sidawy, Beth H. Sutton, and Steven D. Wexner.
Visit the Bulletin website at http://bit.ly/2l69j2Y for a list of criteria for each nominating committee, as well as further details on how to submit a nomination and the nomination process. The deadline for submitting nominations is February 23, 2018.
Nominations may be submitted to [email protected]. If you have any questions, contact Emily Kalata, Staff Liaison for the NCF and NCBG, at 312-202-5360 or [email protected].
The American College of Surgeons (ACS) 2018 Nominating Committee of the Fellows (NCF) and the Nominating Committee of the Board of Governors (NCBG) will be selecting nominees for leadership positions in the College.
The 2018 NCF will select nominees for the three Officer-Elect positions of the ACS:
• President-Elect
• First Vice-President-Elect
• Second Vice-President-Elect
The 2018 NCBG will select nominees for pending vacancies on the Board of Regents to be filled at Clinical Congress 2018. Nominations are open to surgeons of all specialties, but particular consideration will be given this nomination cycle to those in the following specialties:
• Burn and critical care surgery
• Gastrointestinal surgery
• General surgery
• Surgical oncology
• Transplantation
• Trauma
• Vascular surgery
For information only, the members of the Board of Regents who will be considered for reelection in 2018 are (all MD, FACS) John L. D. Atkinson, James C. Denneny III, Timothy J. Eberlein, Henri R. Ford, Enrique Hernandez, L. Scott Levin, Linda Phillips, Anton A. Sidawy, Beth H. Sutton, and Steven D. Wexner.
Visit the Bulletin website at http://bit.ly/2l69j2Y for a list of criteria for each nominating committee, as well as further details on how to submit a nomination and the nomination process. The deadline for submitting nominations is February 23, 2018.
Nominations may be submitted to [email protected]. If you have any questions, contact Emily Kalata, Staff Liaison for the NCF and NCBG, at 312-202-5360 or [email protected].
The American College of Surgeons (ACS) 2018 Nominating Committee of the Fellows (NCF) and the Nominating Committee of the Board of Governors (NCBG) will be selecting nominees for leadership positions in the College.
The 2018 NCF will select nominees for the three Officer-Elect positions of the ACS:
• President-Elect
• First Vice-President-Elect
• Second Vice-President-Elect
The 2018 NCBG will select nominees for pending vacancies on the Board of Regents to be filled at Clinical Congress 2018. Nominations are open to surgeons of all specialties, but particular consideration will be given this nomination cycle to those in the following specialties:
• Burn and critical care surgery
• Gastrointestinal surgery
• General surgery
• Surgical oncology
• Transplantation
• Trauma
• Vascular surgery
For information only, the members of the Board of Regents who will be considered for reelection in 2018 are (all MD, FACS) John L. D. Atkinson, James C. Denneny III, Timothy J. Eberlein, Henri R. Ford, Enrique Hernandez, L. Scott Levin, Linda Phillips, Anton A. Sidawy, Beth H. Sutton, and Steven D. Wexner.
Visit the Bulletin website at http://bit.ly/2l69j2Y for a list of criteria for each nominating committee, as well as further details on how to submit a nomination and the nomination process. The deadline for submitting nominations is February 23, 2018.
Nominations may be submitted to [email protected]. If you have any questions, contact Emily Kalata, Staff Liaison for the NCF and NCBG, at 312-202-5360 or [email protected].