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NEW ORLEANS – Cell-free (cf) DNA looked like an informative biomarker for both the severity of pulmonary artery hypertension and the survival prognosis for patients with this disease, based on results from two preliminary studies involving a total of 173 people.

Mitchel L. Zoler/MDedge News

“Plasma levels of cell-free DNA are elevated in patients with pulmonary artery hypertension, compared with healthy controls, and may predict disease severity and mortality,” Samuel B. Brusca, MD, said at the at the annual meeting of the American College of Cardiology.

A growing biomedical literature has documented a role for cfDNA in tracking the course of cancer, septic shock, and transplanted organs (Transplantation. 2019 Feb;103[2]:273-83) (Cell-Free DNA: Applications in Different Diseases, in “Cell-free DNA as Diagnostic Markers.” [New York: Humana Press, 2018, pp. 3-12]). Based on this background Dr. Brusca and his associates decided to examine whether plasma levels of cfDNA linked with pulmonary artery hypertension (PAH) severity and survival.

Their first study included seven patients with mild PAH (defined as patients with a tricuspid annular plane systolic excursion [TAPSE] of more than 18 mm and a maximum oxygen uptake [VO₂] of at least 75% of predicted), eight with severe PAH (a TAPSE of 18 mm or less and a VO₂ of less than 75%), and seven healthy adult controls. Measurement of plasma cfDNA showed an average level of 19.4 ng/mL among the healthy controls (prior reports had indicated that 10-20 ng/mL were normal levels), 22.0 ng/mL among patients with mild PAH, and 36.2 ng/mL in those with severe PAH. The level among the severe PAH patients was significantly higher than the level in controls by two different statistical tests, said Dr. Brusca, a critical care medicine physician at the National Institutes of Health Clinical Center in Bethesda, Md.

The second analysis by Dr. Brusca and his associates included 151 PAH patients followed by physicians at the Clinical Center for an average of 40 months. Their analysis tracked survival of these patients relative to their baseline levels of cfDNA and divided into tertiles. Patients in the lowest tertile had a starting cfDNA level of up to 39 ng/mL, those in the middle tertile had levels of 39.1-64.0 ng/mL, and those in the top tertile had levels of at least 64.1 ng/mL. A Kaplan-Meier analysis showed statistically significant differences in survival rates between each of the tertiles. Patients in the lowest tertile had a 5-year actuarial survival rate of about 65%, those in the middle tertile had a survival rate of about 48%, and those in the tertile with the highest level of cfDNA had a survival rate of about 28%.

Additional studies of cfDNA are needed in larger numbers of PAH patients, and cfDNA levels should be compared with levels of other, more established biomarkers, such as inflammatory cytokines, Dr. Brusca said in an interview.

Dr. Brusca had no disclosures. The study received no commercial funding.

mzoler@mdedge.com

SOURCE: Brusca SB et al. J Am Coll Cardiol. 2019 March 12;73(9 Suppl 1):1897.

NEW ORLEANS – Cell-free (cf) DNA looked like an informative biomarker for both the severity of pulmonary artery hypertension and the survival prognosis for patients with this disease, based on results from two preliminary studies involving a total of 173 people.

Mitchel L. Zoler/MDedge News

“Plasma levels of cell-free DNA are elevated in patients with pulmonary artery hypertension, compared with healthy controls, and may predict disease severity and mortality,” Samuel B. Brusca, MD, said at the at the annual meeting of the American College of Cardiology.

A growing biomedical literature has documented a role for cfDNA in tracking the course of cancer, septic shock, and transplanted organs (Transplantation. 2019 Feb;103[2]:273-83) (Cell-Free DNA: Applications in Different Diseases, in “Cell-free DNA as Diagnostic Markers.” [New York: Humana Press, 2018, pp. 3-12]). Based on this background Dr. Brusca and his associates decided to examine whether plasma levels of cfDNA linked with pulmonary artery hypertension (PAH) severity and survival.

Their first study included seven patients with mild PAH (defined as patients with a tricuspid annular plane systolic excursion [TAPSE] of more than 18 mm and a maximum oxygen uptake [VO₂] of at least 75% of predicted), eight with severe PAH (a TAPSE of 18 mm or less and a VO₂ of less than 75%), and seven healthy adult controls. Measurement of plasma cfDNA showed an average level of 19.4 ng/mL among the healthy controls (prior reports had indicated that 10-20 ng/mL were normal levels), 22.0 ng/mL among patients with mild PAH, and 36.2 ng/mL in those with severe PAH. The level among the severe PAH patients was significantly higher than the level in controls by two different statistical tests, said Dr. Brusca, a critical care medicine physician at the National Institutes of Health Clinical Center in Bethesda, Md.

The second analysis by Dr. Brusca and his associates included 151 PAH patients followed by physicians at the Clinical Center for an average of 40 months. Their analysis tracked survival of these patients relative to their baseline levels of cfDNA and divided into tertiles. Patients in the lowest tertile had a starting cfDNA level of up to 39 ng/mL, those in the middle tertile had levels of 39.1-64.0 ng/mL, and those in the top tertile had levels of at least 64.1 ng/mL. A Kaplan-Meier analysis showed statistically significant differences in survival rates between each of the tertiles. Patients in the lowest tertile had a 5-year actuarial survival rate of about 65%, those in the middle tertile had a survival rate of about 48%, and those in the tertile with the highest level of cfDNA had a survival rate of about 28%.

Additional studies of cfDNA are needed in larger numbers of PAH patients, and cfDNA levels should be compared with levels of other, more established biomarkers, such as inflammatory cytokines, Dr. Brusca said in an interview.

Dr. Brusca had no disclosures. The study received no commercial funding.

mzoler@mdedge.com

SOURCE: Brusca SB et al. J Am Coll Cardiol. 2019 March 12;73(9 Suppl 1):1897.

NEW ORLEANS – Cell-free (cf) DNA looked like an informative biomarker for both the severity of pulmonary artery hypertension and the survival prognosis for patients with this disease, based on results from two preliminary studies involving a total of 173 people.

Mitchel L. Zoler/MDedge News

“Plasma levels of cell-free DNA are elevated in patients with pulmonary artery hypertension, compared with healthy controls, and may predict disease severity and mortality,” Samuel B. Brusca, MD, said at the at the annual meeting of the American College of Cardiology.

A growing biomedical literature has documented a role for cfDNA in tracking the course of cancer, septic shock, and transplanted organs (Transplantation. 2019 Feb;103[2]:273-83) (Cell-Free DNA: Applications in Different Diseases, in “Cell-free DNA as Diagnostic Markers.” [New York: Humana Press, 2018, pp. 3-12]). Based on this background Dr. Brusca and his associates decided to examine whether plasma levels of cfDNA linked with pulmonary artery hypertension (PAH) severity and survival.

Their first study included seven patients with mild PAH (defined as patients with a tricuspid annular plane systolic excursion [TAPSE] of more than 18 mm and a maximum oxygen uptake [VO₂] of at least 75% of predicted), eight with severe PAH (a TAPSE of 18 mm or less and a VO₂ of less than 75%), and seven healthy adult controls. Measurement of plasma cfDNA showed an average level of 19.4 ng/mL among the healthy controls (prior reports had indicated that 10-20 ng/mL were normal levels), 22.0 ng/mL among patients with mild PAH, and 36.2 ng/mL in those with severe PAH. The level among the severe PAH patients was significantly higher than the level in controls by two different statistical tests, said Dr. Brusca, a critical care medicine physician at the National Institutes of Health Clinical Center in Bethesda, Md.

The second analysis by Dr. Brusca and his associates included 151 PAH patients followed by physicians at the Clinical Center for an average of 40 months. Their analysis tracked survival of these patients relative to their baseline levels of cfDNA and divided into tertiles. Patients in the lowest tertile had a starting cfDNA level of up to 39 ng/mL, those in the middle tertile had levels of 39.1-64.0 ng/mL, and those in the top tertile had levels of at least 64.1 ng/mL. A Kaplan-Meier analysis showed statistically significant differences in survival rates between each of the tertiles. Patients in the lowest tertile had a 5-year actuarial survival rate of about 65%, those in the middle tertile had a survival rate of about 48%, and those in the tertile with the highest level of cfDNA had a survival rate of about 28%.

Additional studies of cfDNA are needed in larger numbers of PAH patients, and cfDNA levels should be compared with levels of other, more established biomarkers, such as inflammatory cytokines, Dr. Brusca said in an interview.

Dr. Brusca had no disclosures. The study received no commercial funding.

mzoler@mdedge.com

SOURCE: Brusca SB et al. J Am Coll Cardiol. 2019 March 12;73(9 Suppl 1):1897.

Preventing low oxygen, low blood pressure, and hyperventilation in people with head injury has been shown to improve survival, according to observational studies. The guidelines for prehospital management of traumatic brain injury (TBI), developed in 2000, were updated in 2007 to reflect those findings. But are they being followed? And if followed, do they help?

The Excellence in Prehospital Injury Care (EPIC) study, the first time the guidelines were assessed in real-world conditions, trained EMS responders in Arizona and compared patient outcomes before and after the guideline implementation.

The study researchers found “a therapeutic sweet spot” in that the guidelines had an “enormous impact” on people with severe TBI. Implementing the guidelines did not affect overall survival of the entire group, which included > 21,000 patients with moderate, severe, and critical injuries. But further analysis showed that they helped double the survival rate of people with severe TBI and tripled the survival rate in severe TBI patients who had to have a breathing tube inserted by EMS personnel.

Daniel Spaite, MD, who led the study, said the patients with moderate injuries would most likely have survived anyway, and those in critical condition may have had injuries too serious to overcome.

The guidelines also were associated with an overall increase in survival to hospital admission.

According to Bentley Bobrow, MD, co-principal investigator, “It was exciting to see such dramatic outcomes resulting from a simple 2-hour training session with EMS personnel.”

The study “demonstrates the significance of conducting studies in real-world settings and brings a strong evidence base to the guidelines,” said Patrick Bellgowan, PhD, program director at the National Institute of Neurological Disorders and Stroke, which supported the study. “It suggests we can systematically increase the chances of saving lives of thousands of people who suffer severe traumatic brain injuries.”

Preventing low oxygen, low blood pressure, and hyperventilation in people with head injury has been shown to improve survival, according to observational studies. The guidelines for prehospital management of traumatic brain injury (TBI), developed in 2000, were updated in 2007 to reflect those findings. But are they being followed? And if followed, do they help?

The Excellence in Prehospital Injury Care (EPIC) study, the first time the guidelines were assessed in real-world conditions, trained EMS responders in Arizona and compared patient outcomes before and after the guideline implementation.

The study researchers found “a therapeutic sweet spot” in that the guidelines had an “enormous impact” on people with severe TBI. Implementing the guidelines did not affect overall survival of the entire group, which included > 21,000 patients with moderate, severe, and critical injuries. But further analysis showed that they helped double the survival rate of people with severe TBI and tripled the survival rate in severe TBI patients who had to have a breathing tube inserted by EMS personnel.

Daniel Spaite, MD, who led the study, said the patients with moderate injuries would most likely have survived anyway, and those in critical condition may have had injuries too serious to overcome.

The guidelines also were associated with an overall increase in survival to hospital admission.

According to Bentley Bobrow, MD, co-principal investigator, “It was exciting to see such dramatic outcomes resulting from a simple 2-hour training session with EMS personnel.”

The study “demonstrates the significance of conducting studies in real-world settings and brings a strong evidence base to the guidelines,” said Patrick Bellgowan, PhD, program director at the National Institute of Neurological Disorders and Stroke, which supported the study. “It suggests we can systematically increase the chances of saving lives of thousands of people who suffer severe traumatic brain injuries.”

Preventing low oxygen, low blood pressure, and hyperventilation in people with head injury has been shown to improve survival, according to observational studies. The guidelines for prehospital management of traumatic brain injury (TBI), developed in 2000, were updated in 2007 to reflect those findings. But are they being followed? And if followed, do they help?

The Excellence in Prehospital Injury Care (EPIC) study, the first time the guidelines were assessed in real-world conditions, trained EMS responders in Arizona and compared patient outcomes before and after the guideline implementation.

The study researchers found “a therapeutic sweet spot” in that the guidelines had an “enormous impact” on people with severe TBI. Implementing the guidelines did not affect overall survival of the entire group, which included > 21,000 patients with moderate, severe, and critical injuries. But further analysis showed that they helped double the survival rate of people with severe TBI and tripled the survival rate in severe TBI patients who had to have a breathing tube inserted by EMS personnel.

Daniel Spaite, MD, who led the study, said the patients with moderate injuries would most likely have survived anyway, and those in critical condition may have had injuries too serious to overcome.

The guidelines also were associated with an overall increase in survival to hospital admission.

According to Bentley Bobrow, MD, co-principal investigator, “It was exciting to see such dramatic outcomes resulting from a simple 2-hour training session with EMS personnel.”

The study “demonstrates the significance of conducting studies in real-world settings and brings a strong evidence base to the guidelines,” said Patrick Bellgowan, PhD, program director at the National Institute of Neurological Disorders and Stroke, which supported the study. “It suggests we can systematically increase the chances of saving lives of thousands of people who suffer severe traumatic brain injuries.”

A Food and Drug Administration Advisory Committee voted that the benefit-risk profile of an inhaled treatment for cystic fibrosis merits approval of the drug – dry powder mannitol (DPM).

Mannitol is a naturally occurring sugar alcohol that is used as a low-calorie sweetener; it is generally recognized as safe when taken enterically. Inhaled DPM, marketed as Aridol, is currently approved as a bronchoprovocation agent. For the current indication, DPM is given as 10x40-mg capsules twice daily.

In a 9-7 vote, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) decided that DPM’s modest potential to improve pulmonary function in adults with cystic fibrosis (CF) outweighed a potential signal for increased exacerbations seen in clinical trials.

Chiesi USA Inc. is seeking approval of DPM for the management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies. It plans to market DPM as Bronchitol.

Some committee members who voted against approval, including PADAC chair David H. Au, MD, worried that DPM’s ease of use might prompt patients and caregivers to substitute it for inhaled hypertonic saline, a medication that’s more burdensome to use but has a longer track record for efficacy and safety. While hypertonic saline requires cumbersome equipment and cleaning regimens and takes 20-30 minutes to administer, DPM is administered over about 5 minutes via a series of capsules inserted into a small inhaler device.

“I was very impressed by conversations that we heard from the community that this will be viewed as a substitute drug [for hypertonic saline],” said Dr. Au, professor of medicine at the University of Washington, Seattle. “Before we make that leap of faith ... we have to better understand how it has to be used.” He also acknowledged that making the call for DPM was “challenging.”

Other committee members were reassured by the fact that DPM is approved for adult use in 35 countries; it’s been in use since 2011 in Australia for adults and children.

Some members also noted an unmet need in CF therapies and placed confidence in those treating CF patients to find ways to use DPM safely and effectively. “I’m really counting on the cystic fibrosis clinicians who do this for a living to figure out where to use this in their armamentarium,” said John M. Kelso, MD, an allergist at Scripps Clinic, San Diego.

In 2012, the initial new drug application submitted by Pharmaxis, which then held marketing rights to DPM, resulted in a “no” vote for approval from PADAC, and eventual FDA denial of approval. The initial submission was supported by two phase 3 clinical trials, 301 and 302, that included pediatric patients. In the pediatric population, there was concern for increased hemoptysis with DPM, so the FDA advised the drug’s marketers to consider seeking approval for an adult population only in its reapplication. The current submission followed a new double-blind, randomized, placebo-controlled trial, study 303, that included adults with CF aged 18 or over.

All three studies had similar designs, tracking change from baseline in forced expiratory volume in one second (FEV₁) from baseline to the end of the 26-week study period. In addition to this primary endpoint, secondary endpoints included other pulmonary function measures, as well as the number of protocol-defined pulmonary exacerbations (PDPEs). Participants also reported quality of life and symptom measures on the Cystic Fibrosis Questionnaire–Revised (CFQ-R).

In study 301, the dropout rate approached one in three participants with higher discontinuation in the intervention than the control arm, causing significant statistical problems in dealing with missing data. Thus, said the FDA’s Robert Lim, MD, though this study had positive results for FEV₁, it was not “statistically robust.”

The second study, 302, did not meet its primary endpoint, and there was “no support from secondary endpoints” for efficacy, said Dr. Lim, a clinical team leader in the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products.

The current submission was also supported by a new post hoc subgroup analysis of adults in studies 301 and 302. A total of 414 patients receiving DPM and 347 receiving placebo (DPM at a nontherapeutic level) were included in the integrated analysis of patients from all three studies. Studies 301 and 302 both had open-label extension arms, allowing more patients to be included in safety data.

The problems caused by the missing data from study 301 were addressed in the design of study 303 by encouraging patients who discontinued the study drug to continue data collection efforts for the study. Dropout rates were lower overall in study 303 and balanced between arms.

Over the 26-week duration of study 303, investigators saw a statistically significant improvement in FEV₁ of about 50 mL, according to the FDA’s analysis. Post hoc analyses of studies 301 and 302 showed point estimate increases of approximately 80 mL, according to Dr. Lim.

In its presentations, Chiesi USA presented its integrated analysis of adult data from the three clinical trials. The analysis showed an increase in FEV₁ from baseline of 73 mL for the DPM group, compared with an increase of 7 mL for the control group, using an intention-to-treat population (P less than .001). The committee heard evidence that in adults with CF, pulmonary function typically decreases by 1%-3% annually.

The PDPE rate was slightly higher in the DPM group than in the control group in studies 302 and 303, but the differences were not statistically significant. These findings have a backdrop of an overall low rate of PDPEs ranging from 0.221 to 0.995 per year, according to Chiesi presenter Scott Donaldson, MD, a pulmonologist who directs the adult cystic fibrosis center at the University of North Carolina at Chapel Hill.

When looking at the subgroup of United States study participants, the DPM integrated cohort included more patients with a history of prior pulmonary exacerbations. In the DPM group, 45% of U.S. participants had at least one exacerbation in the prior year, and 20% had two or more exacerbations, compared with 38% and 14%, respectively, in the control group. Chiesi argued that this imbalance was likely responsible for the increased exacerbation rate.

The sponsor and the FDA used different imputation methods to account for missing data from the earlier studies, complicating interpretation of the potential signal for increased exacerbations.

Quality of life data were similar between groups across the studies.

In the end, the view of the “yes” voters was encapsulated by James M. Tracy, DO, an allergist in private practice in Omaha, Neb. “This is not a drug for everybody; but absolutely, it’s a drug for somebody. Ultimately we have to make that decision – I do think that we study populations, but we really take care of people.”

The FDA usually follows the recommendations of its advisory panels.

koakes@mdedge.com

A Food and Drug Administration Advisory Committee voted that the benefit-risk profile of an inhaled treatment for cystic fibrosis merits approval of the drug – dry powder mannitol (DPM).

Mannitol is a naturally occurring sugar alcohol that is used as a low-calorie sweetener; it is generally recognized as safe when taken enterically. Inhaled DPM, marketed as Aridol, is currently approved as a bronchoprovocation agent. For the current indication, DPM is given as 10x40-mg capsules twice daily.

In a 9-7 vote, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) decided that DPM’s modest potential to improve pulmonary function in adults with cystic fibrosis (CF) outweighed a potential signal for increased exacerbations seen in clinical trials.

Chiesi USA Inc. is seeking approval of DPM for the management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies. It plans to market DPM as Bronchitol.

Some committee members who voted against approval, including PADAC chair David H. Au, MD, worried that DPM’s ease of use might prompt patients and caregivers to substitute it for inhaled hypertonic saline, a medication that’s more burdensome to use but has a longer track record for efficacy and safety. While hypertonic saline requires cumbersome equipment and cleaning regimens and takes 20-30 minutes to administer, DPM is administered over about 5 minutes via a series of capsules inserted into a small inhaler device.

“I was very impressed by conversations that we heard from the community that this will be viewed as a substitute drug [for hypertonic saline],” said Dr. Au, professor of medicine at the University of Washington, Seattle. “Before we make that leap of faith ... we have to better understand how it has to be used.” He also acknowledged that making the call for DPM was “challenging.”

Other committee members were reassured by the fact that DPM is approved for adult use in 35 countries; it’s been in use since 2011 in Australia for adults and children.

Some members also noted an unmet need in CF therapies and placed confidence in those treating CF patients to find ways to use DPM safely and effectively. “I’m really counting on the cystic fibrosis clinicians who do this for a living to figure out where to use this in their armamentarium,” said John M. Kelso, MD, an allergist at Scripps Clinic, San Diego.

In 2012, the initial new drug application submitted by Pharmaxis, which then held marketing rights to DPM, resulted in a “no” vote for approval from PADAC, and eventual FDA denial of approval. The initial submission was supported by two phase 3 clinical trials, 301 and 302, that included pediatric patients. In the pediatric population, there was concern for increased hemoptysis with DPM, so the FDA advised the drug’s marketers to consider seeking approval for an adult population only in its reapplication. The current submission followed a new double-blind, randomized, placebo-controlled trial, study 303, that included adults with CF aged 18 or over.

All three studies had similar designs, tracking change from baseline in forced expiratory volume in one second (FEV₁) from baseline to the end of the 26-week study period. In addition to this primary endpoint, secondary endpoints included other pulmonary function measures, as well as the number of protocol-defined pulmonary exacerbations (PDPEs). Participants also reported quality of life and symptom measures on the Cystic Fibrosis Questionnaire–Revised (CFQ-R).

In study 301, the dropout rate approached one in three participants with higher discontinuation in the intervention than the control arm, causing significant statistical problems in dealing with missing data. Thus, said the FDA’s Robert Lim, MD, though this study had positive results for FEV₁, it was not “statistically robust.”

The second study, 302, did not meet its primary endpoint, and there was “no support from secondary endpoints” for efficacy, said Dr. Lim, a clinical team leader in the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products.

The current submission was also supported by a new post hoc subgroup analysis of adults in studies 301 and 302. A total of 414 patients receiving DPM and 347 receiving placebo (DPM at a nontherapeutic level) were included in the integrated analysis of patients from all three studies. Studies 301 and 302 both had open-label extension arms, allowing more patients to be included in safety data.

The problems caused by the missing data from study 301 were addressed in the design of study 303 by encouraging patients who discontinued the study drug to continue data collection efforts for the study. Dropout rates were lower overall in study 303 and balanced between arms.

Over the 26-week duration of study 303, investigators saw a statistically significant improvement in FEV₁ of about 50 mL, according to the FDA’s analysis. Post hoc analyses of studies 301 and 302 showed point estimate increases of approximately 80 mL, according to Dr. Lim.

In its presentations, Chiesi USA presented its integrated analysis of adult data from the three clinical trials. The analysis showed an increase in FEV₁ from baseline of 73 mL for the DPM group, compared with an increase of 7 mL for the control group, using an intention-to-treat population (P less than .001). The committee heard evidence that in adults with CF, pulmonary function typically decreases by 1%-3% annually.

The PDPE rate was slightly higher in the DPM group than in the control group in studies 302 and 303, but the differences were not statistically significant. These findings have a backdrop of an overall low rate of PDPEs ranging from 0.221 to 0.995 per year, according to Chiesi presenter Scott Donaldson, MD, a pulmonologist who directs the adult cystic fibrosis center at the University of North Carolina at Chapel Hill.

When looking at the subgroup of United States study participants, the DPM integrated cohort included more patients with a history of prior pulmonary exacerbations. In the DPM group, 45% of U.S. participants had at least one exacerbation in the prior year, and 20% had two or more exacerbations, compared with 38% and 14%, respectively, in the control group. Chiesi argued that this imbalance was likely responsible for the increased exacerbation rate.

The sponsor and the FDA used different imputation methods to account for missing data from the earlier studies, complicating interpretation of the potential signal for increased exacerbations.

Quality of life data were similar between groups across the studies.

In the end, the view of the “yes” voters was encapsulated by James M. Tracy, DO, an allergist in private practice in Omaha, Neb. “This is not a drug for everybody; but absolutely, it’s a drug for somebody. Ultimately we have to make that decision – I do think that we study populations, but we really take care of people.”

The FDA usually follows the recommendations of its advisory panels.

koakes@mdedge.com

A Food and Drug Administration Advisory Committee voted that the benefit-risk profile of an inhaled treatment for cystic fibrosis merits approval of the drug – dry powder mannitol (DPM).

Mannitol is a naturally occurring sugar alcohol that is used as a low-calorie sweetener; it is generally recognized as safe when taken enterically. Inhaled DPM, marketed as Aridol, is currently approved as a bronchoprovocation agent. For the current indication, DPM is given as 10x40-mg capsules twice daily.

In a 9-7 vote, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) decided that DPM’s modest potential to improve pulmonary function in adults with cystic fibrosis (CF) outweighed a potential signal for increased exacerbations seen in clinical trials.

Chiesi USA Inc. is seeking approval of DPM for the management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies. It plans to market DPM as Bronchitol.

Some committee members who voted against approval, including PADAC chair David H. Au, MD, worried that DPM’s ease of use might prompt patients and caregivers to substitute it for inhaled hypertonic saline, a medication that’s more burdensome to use but has a longer track record for efficacy and safety. While hypertonic saline requires cumbersome equipment and cleaning regimens and takes 20-30 minutes to administer, DPM is administered over about 5 minutes via a series of capsules inserted into a small inhaler device.

“I was very impressed by conversations that we heard from the community that this will be viewed as a substitute drug [for hypertonic saline],” said Dr. Au, professor of medicine at the University of Washington, Seattle. “Before we make that leap of faith ... we have to better understand how it has to be used.” He also acknowledged that making the call for DPM was “challenging.”

Other committee members were reassured by the fact that DPM is approved for adult use in 35 countries; it’s been in use since 2011 in Australia for adults and children.

Some members also noted an unmet need in CF therapies and placed confidence in those treating CF patients to find ways to use DPM safely and effectively. “I’m really counting on the cystic fibrosis clinicians who do this for a living to figure out where to use this in their armamentarium,” said John M. Kelso, MD, an allergist at Scripps Clinic, San Diego.

In 2012, the initial new drug application submitted by Pharmaxis, which then held marketing rights to DPM, resulted in a “no” vote for approval from PADAC, and eventual FDA denial of approval. The initial submission was supported by two phase 3 clinical trials, 301 and 302, that included pediatric patients. In the pediatric population, there was concern for increased hemoptysis with DPM, so the FDA advised the drug’s marketers to consider seeking approval for an adult population only in its reapplication. The current submission followed a new double-blind, randomized, placebo-controlled trial, study 303, that included adults with CF aged 18 or over.

All three studies had similar designs, tracking change from baseline in forced expiratory volume in one second (FEV₁) from baseline to the end of the 26-week study period. In addition to this primary endpoint, secondary endpoints included other pulmonary function measures, as well as the number of protocol-defined pulmonary exacerbations (PDPEs). Participants also reported quality of life and symptom measures on the Cystic Fibrosis Questionnaire–Revised (CFQ-R).

In study 301, the dropout rate approached one in three participants with higher discontinuation in the intervention than the control arm, causing significant statistical problems in dealing with missing data. Thus, said the FDA’s Robert Lim, MD, though this study had positive results for FEV₁, it was not “statistically robust.”

The second study, 302, did not meet its primary endpoint, and there was “no support from secondary endpoints” for efficacy, said Dr. Lim, a clinical team leader in the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products.

The current submission was also supported by a new post hoc subgroup analysis of adults in studies 301 and 302. A total of 414 patients receiving DPM and 347 receiving placebo (DPM at a nontherapeutic level) were included in the integrated analysis of patients from all three studies. Studies 301 and 302 both had open-label extension arms, allowing more patients to be included in safety data.

The problems caused by the missing data from study 301 were addressed in the design of study 303 by encouraging patients who discontinued the study drug to continue data collection efforts for the study. Dropout rates were lower overall in study 303 and balanced between arms.

Over the 26-week duration of study 303, investigators saw a statistically significant improvement in FEV₁ of about 50 mL, according to the FDA’s analysis. Post hoc analyses of studies 301 and 302 showed point estimate increases of approximately 80 mL, according to Dr. Lim.

In its presentations, Chiesi USA presented its integrated analysis of adult data from the three clinical trials. The analysis showed an increase in FEV₁ from baseline of 73 mL for the DPM group, compared with an increase of 7 mL for the control group, using an intention-to-treat population (P less than .001). The committee heard evidence that in adults with CF, pulmonary function typically decreases by 1%-3% annually.

The PDPE rate was slightly higher in the DPM group than in the control group in studies 302 and 303, but the differences were not statistically significant. These findings have a backdrop of an overall low rate of PDPEs ranging from 0.221 to 0.995 per year, according to Chiesi presenter Scott Donaldson, MD, a pulmonologist who directs the adult cystic fibrosis center at the University of North Carolina at Chapel Hill.

When looking at the subgroup of United States study participants, the DPM integrated cohort included more patients with a history of prior pulmonary exacerbations. In the DPM group, 45% of U.S. participants had at least one exacerbation in the prior year, and 20% had two or more exacerbations, compared with 38% and 14%, respectively, in the control group. Chiesi argued that this imbalance was likely responsible for the increased exacerbation rate.

The sponsor and the FDA used different imputation methods to account for missing data from the earlier studies, complicating interpretation of the potential signal for increased exacerbations.

Quality of life data were similar between groups across the studies.

In the end, the view of the “yes” voters was encapsulated by James M. Tracy, DO, an allergist in private practice in Omaha, Neb. “This is not a drug for everybody; but absolutely, it’s a drug for somebody. Ultimately we have to make that decision – I do think that we study populations, but we really take care of people.”

The FDA usually follows the recommendations of its advisory panels.

koakes@mdedge.com

BALTIMORE – In children with pharyngitis, it’s safe to skip group A Streptococcus testing if there are no exudates, children are 11 years or older, and there is either no cervical adenopathy or adenopathy without fever, according to a Boston Children’s Hospital investigation.

LightFieldStudios/iStock/Getty Images Plus

The prevalence of group A Streptococcus among children who meet those criteria is 13%, less than the estimated asymptomatic carriage rate of about 15%. Among 67,127 children tested for strep and treated for sore throats in a network of retail health clinics across the United States, 35% fit the profile.

Investigators led by Daniel Shapiro, MD, a pediatrics fellow at Boston Children’s, concluded that “laboratory testing for GAS [group A Streptococcus] might be safely avoided in a large proportion of patients with sore throats. In doing so, we may avoid some of the downstream effects of unnecessary antibiotic use.” Incorporating the rules into EHRs “might help physicians identify patients who are at low risk of GAS pharyngitis.”

The study team tackled a long-standing and vexing problem in general pediatrics: how to distinguish viral from GAS pharyngitis. They often present the same way, so it’s difficult to tell them apart, but important to do so to prevent misuse of antibiotics. Health care providers generally rely on rapid strep tests and other assays to make the call, but they have to be used cautiously, because asymptomatic carriers also will test positive and be at risk for unnecessary treatment, Dr. Shapiro said at the Pediatric Academic Societies annual meeting.

To try to prevent that, the Infectious Disease Society of America (IDSA) recommends against strep testing in children who present with overt viral signs, including cough, rhinorrhea, oral ulcers, and hoarseness (Clin Infect Dis. 2012 Nov 15;55[10]:1279-82).

In a previous study at Boston Children’s ED, however, Dr. Shapiro and his colleagues found that 29% of children with overt viral features were positive for GAS, suggesting that the IDSA guidelines probably go too far (Pediatrics. 2017 May;139[5]. pii: e20163403).

“One might conclude that while it’s a good rule of thumb to avoid testing patients with viral features, some of the patients with viral features really do have GAS pharyngitis, so the recommendation to forgo testing in all these kids needs a little bit of refinement,” he said.

That was the goal of the new study; the team sought to identify viral features that signaled a low risk of GAS pharyngitis and, therefore, no need for testing. Low risk was defined as less than 15%, in keeping with the asymptomatic carriage rate.

The 67,127 patients were aged 3-21 years. Their signs and symptoms were collected at the retail clinics in a standardized form. The subjects had rapid strep tests, with negative results confirmed by DNA probe or culture.

Fifty-four percent had viral features, defined in the study as cough, runny nose, or hoarseness (oral ulcers weren’t collected on the form). The overall prevalence of GAS was 35%, similar to previous studies; 39% of children with no viral features tested positive for GAS versus 26% of children with all three. Exudates and age below 11 years were strongly associated with GAS among patients with viral features.

It turned out that just 23% of children without exudates were GAS positive; the number fell to 15% when limited to children 11 years or older, and to 13% when either no cervical adenopathy or adenopathy without fever were added to the mix. So skip the strep test in pharyngitis when there are no exudates in children 11 years or older lacking cervical adenopathy or who have adenopathy without fever.

There was no industry funding, and Dr. Shapiro didn’t have any disclosures.

aotto@mdedge.com

BALTIMORE – In children with pharyngitis, it’s safe to skip group A Streptococcus testing if there are no exudates, children are 11 years or older, and there is either no cervical adenopathy or adenopathy without fever, according to a Boston Children’s Hospital investigation.

LightFieldStudios/iStock/Getty Images Plus

The prevalence of group A Streptococcus among children who meet those criteria is 13%, less than the estimated asymptomatic carriage rate of about 15%. Among 67,127 children tested for strep and treated for sore throats in a network of retail health clinics across the United States, 35% fit the profile.

Investigators led by Daniel Shapiro, MD, a pediatrics fellow at Boston Children’s, concluded that “laboratory testing for GAS [group A Streptococcus] might be safely avoided in a large proportion of patients with sore throats. In doing so, we may avoid some of the downstream effects of unnecessary antibiotic use.” Incorporating the rules into EHRs “might help physicians identify patients who are at low risk of GAS pharyngitis.”

The study team tackled a long-standing and vexing problem in general pediatrics: how to distinguish viral from GAS pharyngitis. They often present the same way, so it’s difficult to tell them apart, but important to do so to prevent misuse of antibiotics. Health care providers generally rely on rapid strep tests and other assays to make the call, but they have to be used cautiously, because asymptomatic carriers also will test positive and be at risk for unnecessary treatment, Dr. Shapiro said at the Pediatric Academic Societies annual meeting.

To try to prevent that, the Infectious Disease Society of America (IDSA) recommends against strep testing in children who present with overt viral signs, including cough, rhinorrhea, oral ulcers, and hoarseness (Clin Infect Dis. 2012 Nov 15;55[10]:1279-82).

In a previous study at Boston Children’s ED, however, Dr. Shapiro and his colleagues found that 29% of children with overt viral features were positive for GAS, suggesting that the IDSA guidelines probably go too far (Pediatrics. 2017 May;139[5]. pii: e20163403).

“One might conclude that while it’s a good rule of thumb to avoid testing patients with viral features, some of the patients with viral features really do have GAS pharyngitis, so the recommendation to forgo testing in all these kids needs a little bit of refinement,” he said.

That was the goal of the new study; the team sought to identify viral features that signaled a low risk of GAS pharyngitis and, therefore, no need for testing. Low risk was defined as less than 15%, in keeping with the asymptomatic carriage rate.

The 67,127 patients were aged 3-21 years. Their signs and symptoms were collected at the retail clinics in a standardized form. The subjects had rapid strep tests, with negative results confirmed by DNA probe or culture.

Fifty-four percent had viral features, defined in the study as cough, runny nose, or hoarseness (oral ulcers weren’t collected on the form). The overall prevalence of GAS was 35%, similar to previous studies; 39% of children with no viral features tested positive for GAS versus 26% of children with all three. Exudates and age below 11 years were strongly associated with GAS among patients with viral features.

It turned out that just 23% of children without exudates were GAS positive; the number fell to 15% when limited to children 11 years or older, and to 13% when either no cervical adenopathy or adenopathy without fever were added to the mix. So skip the strep test in pharyngitis when there are no exudates in children 11 years or older lacking cervical adenopathy or who have adenopathy without fever.

There was no industry funding, and Dr. Shapiro didn’t have any disclosures.

aotto@mdedge.com

BALTIMORE – In children with pharyngitis, it’s safe to skip group A Streptococcus testing if there are no exudates, children are 11 years or older, and there is either no cervical adenopathy or adenopathy without fever, according to a Boston Children’s Hospital investigation.

LightFieldStudios/iStock/Getty Images Plus

The prevalence of group A Streptococcus among children who meet those criteria is 13%, less than the estimated asymptomatic carriage rate of about 15%. Among 67,127 children tested for strep and treated for sore throats in a network of retail health clinics across the United States, 35% fit the profile.

Investigators led by Daniel Shapiro, MD, a pediatrics fellow at Boston Children’s, concluded that “laboratory testing for GAS [group A Streptococcus] might be safely avoided in a large proportion of patients with sore throats. In doing so, we may avoid some of the downstream effects of unnecessary antibiotic use.” Incorporating the rules into EHRs “might help physicians identify patients who are at low risk of GAS pharyngitis.”

The study team tackled a long-standing and vexing problem in general pediatrics: how to distinguish viral from GAS pharyngitis. They often present the same way, so it’s difficult to tell them apart, but important to do so to prevent misuse of antibiotics. Health care providers generally rely on rapid strep tests and other assays to make the call, but they have to be used cautiously, because asymptomatic carriers also will test positive and be at risk for unnecessary treatment, Dr. Shapiro said at the Pediatric Academic Societies annual meeting.

To try to prevent that, the Infectious Disease Society of America (IDSA) recommends against strep testing in children who present with overt viral signs, including cough, rhinorrhea, oral ulcers, and hoarseness (Clin Infect Dis. 2012 Nov 15;55[10]:1279-82).

In a previous study at Boston Children’s ED, however, Dr. Shapiro and his colleagues found that 29% of children with overt viral features were positive for GAS, suggesting that the IDSA guidelines probably go too far (Pediatrics. 2017 May;139[5]. pii: e20163403).

“One might conclude that while it’s a good rule of thumb to avoid testing patients with viral features, some of the patients with viral features really do have GAS pharyngitis, so the recommendation to forgo testing in all these kids needs a little bit of refinement,” he said.

That was the goal of the new study; the team sought to identify viral features that signaled a low risk of GAS pharyngitis and, therefore, no need for testing. Low risk was defined as less than 15%, in keeping with the asymptomatic carriage rate.

The 67,127 patients were aged 3-21 years. Their signs and symptoms were collected at the retail clinics in a standardized form. The subjects had rapid strep tests, with negative results confirmed by DNA probe or culture.

Fifty-four percent had viral features, defined in the study as cough, runny nose, or hoarseness (oral ulcers weren’t collected on the form). The overall prevalence of GAS was 35%, similar to previous studies; 39% of children with no viral features tested positive for GAS versus 26% of children with all three. Exudates and age below 11 years were strongly associated with GAS among patients with viral features.

It turned out that just 23% of children without exudates were GAS positive; the number fell to 15% when limited to children 11 years or older, and to 13% when either no cervical adenopathy or adenopathy without fever were added to the mix. So skip the strep test in pharyngitis when there are no exudates in children 11 years or older lacking cervical adenopathy or who have adenopathy without fever.

There was no industry funding, and Dr. Shapiro didn’t have any disclosures.

aotto@mdedge.com

The mean number of office visits for otitis media in children younger than 5 years dropped significantly after the introduction of the 13-valent pneumococcal conjugate vaccine, according to findings published in the International Journal of Pediatric Otorhinolaryngology.

KatarzynaBialasiewicz/Thinkstock

Previous studies have shown that more than half of children with otitis media (OM) have serotypes included in the PCV7 vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F), wrote Xiaofeng Zhou, MD, of Pfizer, New York, and colleagues.

To assess the impact of PCV13, with the additional serotypes 1, 3, 5, 6A, 7F, and 19A, the researchers analyzed data from the U.S. National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey for three time periods: pre-PCV7 (1997-1999), after the introduction of PCV7 (2001-2009), and after the introduction of PCV13 (2011-2013).

Between the pre-PCV7 and PCV13 time periods, the researchers found significant reductions in the mean rates of OM visits of 48% and 41% among children younger than 2 years and younger than 5 years, respectively; reductions were 24% and 22%, respectively, when comparing PCV13 and PCV7. Ambulatory care visits for skin rash and trauma were not significantly different among the study periods.

Comparing the PCV7 and PCV13 time periods, the mean number of OM visits per 100 children declined from 84 to 64 per 100 children younger than 2 years, 41 to 34 per 100 children between ages 2 and 5 years, and from 59 to 46 per 100 children younger than 5 years.

The study findings were limited by several factors including the use of an ecologic study design, which was chosen to help reduce selection bias, but that did not show evidence of the field effectiveness of the PCV13 vaccine. Another limitation was the potential misclassification of patients with OM given clinician variability in diagnostic criteria, the researchers noted.

“Our results in this study, while not providing direct evidence of causality, nonetheless suggest a significant and positive impact of the PCV13 vaccination program on otitis media for children less than 5 years of age in the U.S., with further reductions in OM visits observed in PCV13 period following a decade of PCV7 use,” Dr. Zhou and associates said.

The investigators are employed by Pfizer, which funded the study.

SOURCE: Zhou X et al. Int J Pediatr Otorhinolaryngol. 2019 Apr. 119:96-102.

The mean number of office visits for otitis media in children younger than 5 years dropped significantly after the introduction of the 13-valent pneumococcal conjugate vaccine, according to findings published in the International Journal of Pediatric Otorhinolaryngology.

KatarzynaBialasiewicz/Thinkstock

Previous studies have shown that more than half of children with otitis media (OM) have serotypes included in the PCV7 vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F), wrote Xiaofeng Zhou, MD, of Pfizer, New York, and colleagues.

To assess the impact of PCV13, with the additional serotypes 1, 3, 5, 6A, 7F, and 19A, the researchers analyzed data from the U.S. National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey for three time periods: pre-PCV7 (1997-1999), after the introduction of PCV7 (2001-2009), and after the introduction of PCV13 (2011-2013).

Between the pre-PCV7 and PCV13 time periods, the researchers found significant reductions in the mean rates of OM visits of 48% and 41% among children younger than 2 years and younger than 5 years, respectively; reductions were 24% and 22%, respectively, when comparing PCV13 and PCV7. Ambulatory care visits for skin rash and trauma were not significantly different among the study periods.

Comparing the PCV7 and PCV13 time periods, the mean number of OM visits per 100 children declined from 84 to 64 per 100 children younger than 2 years, 41 to 34 per 100 children between ages 2 and 5 years, and from 59 to 46 per 100 children younger than 5 years.

The study findings were limited by several factors including the use of an ecologic study design, which was chosen to help reduce selection bias, but that did not show evidence of the field effectiveness of the PCV13 vaccine. Another limitation was the potential misclassification of patients with OM given clinician variability in diagnostic criteria, the researchers noted.

“Our results in this study, while not providing direct evidence of causality, nonetheless suggest a significant and positive impact of the PCV13 vaccination program on otitis media for children less than 5 years of age in the U.S., with further reductions in OM visits observed in PCV13 period following a decade of PCV7 use,” Dr. Zhou and associates said.

The investigators are employed by Pfizer, which funded the study.

SOURCE: Zhou X et al. Int J Pediatr Otorhinolaryngol. 2019 Apr. 119:96-102.

The mean number of office visits for otitis media in children younger than 5 years dropped significantly after the introduction of the 13-valent pneumococcal conjugate vaccine, according to findings published in the International Journal of Pediatric Otorhinolaryngology.

KatarzynaBialasiewicz/Thinkstock

Previous studies have shown that more than half of children with otitis media (OM) have serotypes included in the PCV7 vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F), wrote Xiaofeng Zhou, MD, of Pfizer, New York, and colleagues.

To assess the impact of PCV13, with the additional serotypes 1, 3, 5, 6A, 7F, and 19A, the researchers analyzed data from the U.S. National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey for three time periods: pre-PCV7 (1997-1999), after the introduction of PCV7 (2001-2009), and after the introduction of PCV13 (2011-2013).

Between the pre-PCV7 and PCV13 time periods, the researchers found significant reductions in the mean rates of OM visits of 48% and 41% among children younger than 2 years and younger than 5 years, respectively; reductions were 24% and 22%, respectively, when comparing PCV13 and PCV7. Ambulatory care visits for skin rash and trauma were not significantly different among the study periods.

Comparing the PCV7 and PCV13 time periods, the mean number of OM visits per 100 children declined from 84 to 64 per 100 children younger than 2 years, 41 to 34 per 100 children between ages 2 and 5 years, and from 59 to 46 per 100 children younger than 5 years.

The study findings were limited by several factors including the use of an ecologic study design, which was chosen to help reduce selection bias, but that did not show evidence of the field effectiveness of the PCV13 vaccine. Another limitation was the potential misclassification of patients with OM given clinician variability in diagnostic criteria, the researchers noted.

“Our results in this study, while not providing direct evidence of causality, nonetheless suggest a significant and positive impact of the PCV13 vaccination program on otitis media for children less than 5 years of age in the U.S., with further reductions in OM visits observed in PCV13 period following a decade of PCV7 use,” Dr. Zhou and associates said.

The investigators are employed by Pfizer, which funded the study.

SOURCE: Zhou X et al. Int J Pediatr Otorhinolaryngol. 2019 Apr. 119:96-102.

“What is my veteran status?” “Should I receive any benefits from VA, like the GI Bill?”

Now women veterans have another convenient way to get answers to questions like those. Texting 855.829.6636 (855.VA.WOMEN) connects women veterans to the Women Veterans Call Center, where they will find information about VA benefits, health care, and resources. The new texting feature aligns the service with those of other VA call centers, the VA says.

Women are among the fastest-growing veteran demographics , the VA says, accounting for > 30% of the increase in veterans who served between 2014 and 2018. The number of women using VA health care services has tripled since 2000 from about 160,000 to > 500,000. But the VA has found that women veterans underuse VA care, largely due to a lack of knowledge about benefits, services, and their eligibility for them. As the number of women veterans continues to grow, the VA says, it is expanding its outreach to ensure they receive enrollment and benefits information through user-friendly and responsive means. The VA says it works to meet the unique requirements of women, “offering privacy, dignity, and sensitivity to gender-specific needs.” In addition to linking callers to information, the call center staff make direct referrals to Women Veteran Program Managers at every VAMC.

Since 2013, the call center has received nearly 83,000 inbound calls and has initiated almost 1.3 million outbound calls, resulting in communication with > 650,000 veterans.

Staffed by trained, compassionate female VA employees (many are also veterans), the call center is available Monday through Friday 8 am to 10 pm ET and Saturdays from 8 am to 6:30 pm ET. Veterans can call for themselves or on behalf of another woman veteran. Calls are free and confidential, texts and chats are anonymous. Veterans can call as often as they like, the VA says—“until you have the answer to your questions.”

For more information about the Women Veterans Call Center, visit https://www.womenshealth.va.gov/programoverview/wvcc.asp.

“What is my veteran status?” “Should I receive any benefits from VA, like the GI Bill?”

Now women veterans have another convenient way to get answers to questions like those. Texting 855.829.6636 (855.VA.WOMEN) connects women veterans to the Women Veterans Call Center, where they will find information about VA benefits, health care, and resources. The new texting feature aligns the service with those of other VA call centers, the VA says.

Women are among the fastest-growing veteran demographics , the VA says, accounting for > 30% of the increase in veterans who served between 2014 and 2018. The number of women using VA health care services has tripled since 2000 from about 160,000 to > 500,000. But the VA has found that women veterans underuse VA care, largely due to a lack of knowledge about benefits, services, and their eligibility for them. As the number of women veterans continues to grow, the VA says, it is expanding its outreach to ensure they receive enrollment and benefits information through user-friendly and responsive means. The VA says it works to meet the unique requirements of women, “offering privacy, dignity, and sensitivity to gender-specific needs.” In addition to linking callers to information, the call center staff make direct referrals to Women Veteran Program Managers at every VAMC.

Since 2013, the call center has received nearly 83,000 inbound calls and has initiated almost 1.3 million outbound calls, resulting in communication with > 650,000 veterans.

Staffed by trained, compassionate female VA employees (many are also veterans), the call center is available Monday through Friday 8 am to 10 pm ET and Saturdays from 8 am to 6:30 pm ET. Veterans can call for themselves or on behalf of another woman veteran. Calls are free and confidential, texts and chats are anonymous. Veterans can call as often as they like, the VA says—“until you have the answer to your questions.”

For more information about the Women Veterans Call Center, visit https://www.womenshealth.va.gov/programoverview/wvcc.asp.

“What is my veteran status?” “Should I receive any benefits from VA, like the GI Bill?”

Now women veterans have another convenient way to get answers to questions like those. Texting 855.829.6636 (855.VA.WOMEN) connects women veterans to the Women Veterans Call Center, where they will find information about VA benefits, health care, and resources. The new texting feature aligns the service with those of other VA call centers, the VA says.

Women are among the fastest-growing veteran demographics , the VA says, accounting for > 30% of the increase in veterans who served between 2014 and 2018. The number of women using VA health care services has tripled since 2000 from about 160,000 to > 500,000. But the VA has found that women veterans underuse VA care, largely due to a lack of knowledge about benefits, services, and their eligibility for them. As the number of women veterans continues to grow, the VA says, it is expanding its outreach to ensure they receive enrollment and benefits information through user-friendly and responsive means. The VA says it works to meet the unique requirements of women, “offering privacy, dignity, and sensitivity to gender-specific needs.” In addition to linking callers to information, the call center staff make direct referrals to Women Veteran Program Managers at every VAMC.

Since 2013, the call center has received nearly 83,000 inbound calls and has initiated almost 1.3 million outbound calls, resulting in communication with > 650,000 veterans.

Staffed by trained, compassionate female VA employees (many are also veterans), the call center is available Monday through Friday 8 am to 10 pm ET and Saturdays from 8 am to 6:30 pm ET. Veterans can call for themselves or on behalf of another woman veteran. Calls are free and confidential, texts and chats are anonymous. Veterans can call as often as they like, the VA says—“until you have the answer to your questions.”

For more information about the Women Veterans Call Center, visit https://www.womenshealth.va.gov/programoverview/wvcc.asp.

Cigarette smoking has been linked to the diagnosis of bacterial vaginosis (BV) and other genital infections including herpes simplex virus type 2, Chlamydia trachomatis, and oral and genital human papillomavirus (HPV).  Nicotine’s major metabolite, cotinine, has been found to concentrate in cervical mucus.

In 2014, researchers from Montana State University confirmed that the composition of the vaginal microbiota is “strongly associated with smoking.” They reported that women whose vaginal microbiota lacked significant numbers of Lactobacillus spp were 25-fold more likely to report current smoking than those with microbiota dominated by Lactobacillus crispatus (L crispatus). The researchers note that most Lactobacillus spp are thought to provide broad-spectrum protection to pathogenic infections by reducing vaginal pH.

But what is the mechanistic link between smoking and its effects on the vaginal microenvironment? The researchers conducted further study to assess the metabolome, a set of small molecule chemicals that includes host and microbial-produced and modified biomolecules as well as exogenous chemicals. The metabolome is an important characteristic of the vaginal microenvironment; the researchers say; differences in some metabolites are associated with functional variations of the vaginal microbiota. 

The analysis revealed samples clustered into 3 community state types (CSTs): CST-I (L crispatus dominated), CST-III (L iners dominated) and CST-IV (low Lactobacillus). Overall, smoking did not affect the vaginal metabolome after controlling for CSTs, but the researchers identified “an extensive and diverse range” of vaginal metabolites for which profiles were affected by both the microbiology and smoking status. They found 607 compounds in 36 women, including 12 metabolites that differed significantly between smokers and nonsmokers. Bacterial composition was the most pronounced driver of the vaginal metabolome, they say, associated with changes in 57% of all metabolites. As expected, nicotine, cotinine, and hydroxycotinine were markedly elevated in smokers’ vaginas.

Another “key finding,” the researchers say, was a significant increase in the abundance of various biogenic amines among smokers, far more pronounced in women with a low level of Lactobacillus. Biogenic amines are essential, they note, to mammalian and bacterial physiology. (Several are implicated in the “fishy” odor of BV.)

Their study serves as a pilot study, the researchers say, for future examinations of the connections between smoking and poor gynecologic and reproductive health outcomes.

Cigarette smoking has been linked to the diagnosis of bacterial vaginosis (BV) and other genital infections including herpes simplex virus type 2, Chlamydia trachomatis, and oral and genital human papillomavirus (HPV).  Nicotine’s major metabolite, cotinine, has been found to concentrate in cervical mucus.

In 2014, researchers from Montana State University confirmed that the composition of the vaginal microbiota is “strongly associated with smoking.” They reported that women whose vaginal microbiota lacked significant numbers of Lactobacillus spp were 25-fold more likely to report current smoking than those with microbiota dominated by Lactobacillus crispatus (L crispatus). The researchers note that most Lactobacillus spp are thought to provide broad-spectrum protection to pathogenic infections by reducing vaginal pH.

But what is the mechanistic link between smoking and its effects on the vaginal microenvironment? The researchers conducted further study to assess the metabolome, a set of small molecule chemicals that includes host and microbial-produced and modified biomolecules as well as exogenous chemicals. The metabolome is an important characteristic of the vaginal microenvironment; the researchers say; differences in some metabolites are associated with functional variations of the vaginal microbiota. 

The analysis revealed samples clustered into 3 community state types (CSTs): CST-I (L crispatus dominated), CST-III (L iners dominated) and CST-IV (low Lactobacillus). Overall, smoking did not affect the vaginal metabolome after controlling for CSTs, but the researchers identified “an extensive and diverse range” of vaginal metabolites for which profiles were affected by both the microbiology and smoking status. They found 607 compounds in 36 women, including 12 metabolites that differed significantly between smokers and nonsmokers. Bacterial composition was the most pronounced driver of the vaginal metabolome, they say, associated with changes in 57% of all metabolites. As expected, nicotine, cotinine, and hydroxycotinine were markedly elevated in smokers’ vaginas.

Another “key finding,” the researchers say, was a significant increase in the abundance of various biogenic amines among smokers, far more pronounced in women with a low level of Lactobacillus. Biogenic amines are essential, they note, to mammalian and bacterial physiology. (Several are implicated in the “fishy” odor of BV.)

Their study serves as a pilot study, the researchers say, for future examinations of the connections between smoking and poor gynecologic and reproductive health outcomes.

Cigarette smoking has been linked to the diagnosis of bacterial vaginosis (BV) and other genital infections including herpes simplex virus type 2, Chlamydia trachomatis, and oral and genital human papillomavirus (HPV).  Nicotine’s major metabolite, cotinine, has been found to concentrate in cervical mucus.

In 2014, researchers from Montana State University confirmed that the composition of the vaginal microbiota is “strongly associated with smoking.” They reported that women whose vaginal microbiota lacked significant numbers of Lactobacillus spp were 25-fold more likely to report current smoking than those with microbiota dominated by Lactobacillus crispatus (L crispatus). The researchers note that most Lactobacillus spp are thought to provide broad-spectrum protection to pathogenic infections by reducing vaginal pH.

But what is the mechanistic link between smoking and its effects on the vaginal microenvironment? The researchers conducted further study to assess the metabolome, a set of small molecule chemicals that includes host and microbial-produced and modified biomolecules as well as exogenous chemicals. The metabolome is an important characteristic of the vaginal microenvironment; the researchers say; differences in some metabolites are associated with functional variations of the vaginal microbiota. 

The analysis revealed samples clustered into 3 community state types (CSTs): CST-I (L crispatus dominated), CST-III (L iners dominated) and CST-IV (low Lactobacillus). Overall, smoking did not affect the vaginal metabolome after controlling for CSTs, but the researchers identified “an extensive and diverse range” of vaginal metabolites for which profiles were affected by both the microbiology and smoking status. They found 607 compounds in 36 women, including 12 metabolites that differed significantly between smokers and nonsmokers. Bacterial composition was the most pronounced driver of the vaginal metabolome, they say, associated with changes in 57% of all metabolites. As expected, nicotine, cotinine, and hydroxycotinine were markedly elevated in smokers’ vaginas.

Another “key finding,” the researchers say, was a significant increase in the abundance of various biogenic amines among smokers, far more pronounced in women with a low level of Lactobacillus. Biogenic amines are essential, they note, to mammalian and bacterial physiology. (Several are implicated in the “fishy” odor of BV.)

Their study serves as a pilot study, the researchers say, for future examinations of the connections between smoking and poor gynecologic and reproductive health outcomes.

MAUI, HAWAII – The incidence of methotrexate pneumonitis has been reported as ranging from 3.5% to 7.6% among patients taking the disease-modifying antirheumatic drug. It’s an estimate that Aryeh Fischer, MD, counters with a one-word response: “Nonsense!”

Bruce Jancin/MDedge News

“There’s just no way that methotrexate is causing that much lung disease,” he declared at the 2019 Rheumatology Winter Clinical Symposium.

Dr. Fischer, a rheumatologist with joint appointments to the divisions of rheumatology and pulmonary sciences and critical care medicine at the University of Colorado at Denver, Aurora, noted that his opinion is considered controversial in the pulmonology world.

“I’m not allowed to talk about methotrexate at lung conferences. They stop you at the gate. They’re convinced in lung circles that methotrexate is the worst drug known to mankind,” he said.

Methotrexate pneumonitis is greatly overdiagnosed, Dr. Fischer explained, because it can be extremely difficult to distinguish from an acute flare of interstitial lung disease.

“My take home on methotrexate lung toxicity is this: I would just say, yes, it can occur, but it’s super rare and most often we’re not really sure that it was methotrexate pneumonitis. The diagnosis is not definitive, it’s exclusionary. We know that patients with interstitial lung disease of all types get acute exacerbations, and in idiopathic pulmonary fibrosis it’s actually the leading cause of mortality,” the rheumatologist said.

He highlighted a meta-analysis of 22 randomized, double-blind clinical trials published in 1990-2013 of methotrexate versus placebo or active comparators in 8,584 RA patients. The Irish investigators of that meta-analysis found that methotrexate was associated with a small albeit statistically significant 10% increase in the risk of all adverse respiratory events and an 11% increase in the risk of respiratory infection. However, patients on methotrexate were not at increased risk of mortality because of lung disease. And not a single case of methotrexate pneumonitis was reported after 2002 (Arthritis Rheumatol. 2014 Apr;66[4]:803-12).

Methotrexate pneumonitis is not dose dependent, nor is it related to treatment duration.

“Just because your patient has been on methotrexate for years does not mean they won’t get methotrexate lung toxicity,” he cautioned. “But this is not a chronic fibrotic interstitial lung disease, this is an acute onset of peripheral infiltrates and ground glass opacifications on chest imaging.”

Bronchoalveolar lavage classically shows a hypersensitivity pneumonitis with lymphocytosis. Transbronchial or surgical lung biopsy may show an organizing pneumonia or airway-based nonnecrotizing granulomas, again indicative of a hypersensitivity reaction.

Because the diagnostic picture is so often cloudy, Dr. Fischer generally tries to avoid methotrexate in patients with moderate or severe interstitial lung disease. “I have the luxury of avoiding it because we have so many great arthritis drugs these days,” he noted.

“That being said, the notion that we’re going to stop methotrexate in an 80-year-old who’s been on it for years and has mild bibasilar fibrotic interstitial lung disease so that her lung doc can sleep better at night is not very helpful for our patients. If the patient is doing well on methotrexate and the interstitial lung disease is mild, I continue [the methotrexate],” Dr. Fischer said.

He reported receiving research grants from Boehringer Ingelheim and Corbus Pharmaceuticals and serving as a consultant to Boehringer Ingelheim and other pharmaceutical companies.

bjancin@mdedge.com

MAUI, HAWAII – The incidence of methotrexate pneumonitis has been reported as ranging from 3.5% to 7.6% among patients taking the disease-modifying antirheumatic drug. It’s an estimate that Aryeh Fischer, MD, counters with a one-word response: “Nonsense!”

Bruce Jancin/MDedge News

“There’s just no way that methotrexate is causing that much lung disease,” he declared at the 2019 Rheumatology Winter Clinical Symposium.

Dr. Fischer, a rheumatologist with joint appointments to the divisions of rheumatology and pulmonary sciences and critical care medicine at the University of Colorado at Denver, Aurora, noted that his opinion is considered controversial in the pulmonology world.

“I’m not allowed to talk about methotrexate at lung conferences. They stop you at the gate. They’re convinced in lung circles that methotrexate is the worst drug known to mankind,” he said.

Methotrexate pneumonitis is greatly overdiagnosed, Dr. Fischer explained, because it can be extremely difficult to distinguish from an acute flare of interstitial lung disease.

“My take home on methotrexate lung toxicity is this: I would just say, yes, it can occur, but it’s super rare and most often we’re not really sure that it was methotrexate pneumonitis. The diagnosis is not definitive, it’s exclusionary. We know that patients with interstitial lung disease of all types get acute exacerbations, and in idiopathic pulmonary fibrosis it’s actually the leading cause of mortality,” the rheumatologist said.

He highlighted a meta-analysis of 22 randomized, double-blind clinical trials published in 1990-2013 of methotrexate versus placebo or active comparators in 8,584 RA patients. The Irish investigators of that meta-analysis found that methotrexate was associated with a small albeit statistically significant 10% increase in the risk of all adverse respiratory events and an 11% increase in the risk of respiratory infection. However, patients on methotrexate were not at increased risk of mortality because of lung disease. And not a single case of methotrexate pneumonitis was reported after 2002 (Arthritis Rheumatol. 2014 Apr;66[4]:803-12).

Methotrexate pneumonitis is not dose dependent, nor is it related to treatment duration.

“Just because your patient has been on methotrexate for years does not mean they won’t get methotrexate lung toxicity,” he cautioned. “But this is not a chronic fibrotic interstitial lung disease, this is an acute onset of peripheral infiltrates and ground glass opacifications on chest imaging.”

Bronchoalveolar lavage classically shows a hypersensitivity pneumonitis with lymphocytosis. Transbronchial or surgical lung biopsy may show an organizing pneumonia or airway-based nonnecrotizing granulomas, again indicative of a hypersensitivity reaction.

Because the diagnostic picture is so often cloudy, Dr. Fischer generally tries to avoid methotrexate in patients with moderate or severe interstitial lung disease. “I have the luxury of avoiding it because we have so many great arthritis drugs these days,” he noted.

“That being said, the notion that we’re going to stop methotrexate in an 80-year-old who’s been on it for years and has mild bibasilar fibrotic interstitial lung disease so that her lung doc can sleep better at night is not very helpful for our patients. If the patient is doing well on methotrexate and the interstitial lung disease is mild, I continue [the methotrexate],” Dr. Fischer said.

He reported receiving research grants from Boehringer Ingelheim and Corbus Pharmaceuticals and serving as a consultant to Boehringer Ingelheim and other pharmaceutical companies.

bjancin@mdedge.com

MAUI, HAWAII – The incidence of methotrexate pneumonitis has been reported as ranging from 3.5% to 7.6% among patients taking the disease-modifying antirheumatic drug. It’s an estimate that Aryeh Fischer, MD, counters with a one-word response: “Nonsense!”

Bruce Jancin/MDedge News

“There’s just no way that methotrexate is causing that much lung disease,” he declared at the 2019 Rheumatology Winter Clinical Symposium.

Dr. Fischer, a rheumatologist with joint appointments to the divisions of rheumatology and pulmonary sciences and critical care medicine at the University of Colorado at Denver, Aurora, noted that his opinion is considered controversial in the pulmonology world.

“I’m not allowed to talk about methotrexate at lung conferences. They stop you at the gate. They’re convinced in lung circles that methotrexate is the worst drug known to mankind,” he said.

Methotrexate pneumonitis is greatly overdiagnosed, Dr. Fischer explained, because it can be extremely difficult to distinguish from an acute flare of interstitial lung disease.

“My take home on methotrexate lung toxicity is this: I would just say, yes, it can occur, but it’s super rare and most often we’re not really sure that it was methotrexate pneumonitis. The diagnosis is not definitive, it’s exclusionary. We know that patients with interstitial lung disease of all types get acute exacerbations, and in idiopathic pulmonary fibrosis it’s actually the leading cause of mortality,” the rheumatologist said.

He highlighted a meta-analysis of 22 randomized, double-blind clinical trials published in 1990-2013 of methotrexate versus placebo or active comparators in 8,584 RA patients. The Irish investigators of that meta-analysis found that methotrexate was associated with a small albeit statistically significant 10% increase in the risk of all adverse respiratory events and an 11% increase in the risk of respiratory infection. However, patients on methotrexate were not at increased risk of mortality because of lung disease. And not a single case of methotrexate pneumonitis was reported after 2002 (Arthritis Rheumatol. 2014 Apr;66[4]:803-12).

Methotrexate pneumonitis is not dose dependent, nor is it related to treatment duration.

“Just because your patient has been on methotrexate for years does not mean they won’t get methotrexate lung toxicity,” he cautioned. “But this is not a chronic fibrotic interstitial lung disease, this is an acute onset of peripheral infiltrates and ground glass opacifications on chest imaging.”

Bronchoalveolar lavage classically shows a hypersensitivity pneumonitis with lymphocytosis. Transbronchial or surgical lung biopsy may show an organizing pneumonia or airway-based nonnecrotizing granulomas, again indicative of a hypersensitivity reaction.

Because the diagnostic picture is so often cloudy, Dr. Fischer generally tries to avoid methotrexate in patients with moderate or severe interstitial lung disease. “I have the luxury of avoiding it because we have so many great arthritis drugs these days,” he noted.

“That being said, the notion that we’re going to stop methotrexate in an 80-year-old who’s been on it for years and has mild bibasilar fibrotic interstitial lung disease so that her lung doc can sleep better at night is not very helpful for our patients. If the patient is doing well on methotrexate and the interstitial lung disease is mild, I continue [the methotrexate],” Dr. Fischer said.

He reported receiving research grants from Boehringer Ingelheim and Corbus Pharmaceuticals and serving as a consultant to Boehringer Ingelheim and other pharmaceutical companies.

bjancin@mdedge.com

Public health organizations have learned that when it comes to sharing important information, it pays to capitalize on social media. Platforms like Facebook can not only reach multitudes, but also spread a message far more widely than conventional media can. But what is the best way to leverage social media for public health messages? Researchers from University of Sydney in Australia analyzed 20 Facebook pages on skin cancer, smoking, and other public health issues to find out the most effective strategies for getting users to engage.

The researchers coded 360 days of posts for each page, ending up with 5,356 posts. They categorized the communication techniques as informative, call-to-action, instructive, positive emotive appeal, fear appeal, testimonial, and humor. They also looked at marketing elements, such as whether the page used branding, celebrities or persons of authority, mascots, competitions or giveaways, sponsorships, or vouchers and other offers.

Almost all pages were administered by a nongovernment organization. Mental health and cancer prevention were the most common public health issues. Most posts were photos; the next most common were links (but only 1% of users actually clicked on the links). The most common communication techniques were positive emotional appeal and testimonial. Fear appeal was the least common.

Video posts engaged the most users, getting the most likes and shares, the researchers say. Videos received nearly 4 times as many shares as photo posts; links and text received 30% and 69% fewer shares, respectively. Video and text-only posts received more comments than photo posts. However, the researchers add, this could reflect the Facebook algorithm, which may favor videos over other post types. They also note that only 3% of all posts they coded were videos, “suggesting that public health organizations are trailing behind conventional marketers.”

Posts with positive emotional appeal drew 18% more likes than call-to-action posts, but 27% fewer shares. Informative posts received more than twice as many shares. Fear appeal and humorous posts received more comments than call-to-action posts (perhaps because they are more controversial, the researchers suggest), and instructive posts received fewer.

Conventional marketing, such as using sponsorships or “persons of authority,” generally did not have much engagement. Celebrities and sports figures, though, got 62% more likes, more than double the shares, and 64% more comments than posts without celebrities and sportspeople.

Still, regardless of the post type, communication technique, or marketing element, the researchers say, only 2% to 6% of potential customers engaged with it in some way.

Public health organizations have learned that when it comes to sharing important information, it pays to capitalize on social media. Platforms like Facebook can not only reach multitudes, but also spread a message far more widely than conventional media can. But what is the best way to leverage social media for public health messages? Researchers from University of Sydney in Australia analyzed 20 Facebook pages on skin cancer, smoking, and other public health issues to find out the most effective strategies for getting users to engage.

The researchers coded 360 days of posts for each page, ending up with 5,356 posts. They categorized the communication techniques as informative, call-to-action, instructive, positive emotive appeal, fear appeal, testimonial, and humor. They also looked at marketing elements, such as whether the page used branding, celebrities or persons of authority, mascots, competitions or giveaways, sponsorships, or vouchers and other offers.

Almost all pages were administered by a nongovernment organization. Mental health and cancer prevention were the most common public health issues. Most posts were photos; the next most common were links (but only 1% of users actually clicked on the links). The most common communication techniques were positive emotional appeal and testimonial. Fear appeal was the least common.

Video posts engaged the most users, getting the most likes and shares, the researchers say. Videos received nearly 4 times as many shares as photo posts; links and text received 30% and 69% fewer shares, respectively. Video and text-only posts received more comments than photo posts. However, the researchers add, this could reflect the Facebook algorithm, which may favor videos over other post types. They also note that only 3% of all posts they coded were videos, “suggesting that public health organizations are trailing behind conventional marketers.”

Posts with positive emotional appeal drew 18% more likes than call-to-action posts, but 27% fewer shares. Informative posts received more than twice as many shares. Fear appeal and humorous posts received more comments than call-to-action posts (perhaps because they are more controversial, the researchers suggest), and instructive posts received fewer.

Conventional marketing, such as using sponsorships or “persons of authority,” generally did not have much engagement. Celebrities and sports figures, though, got 62% more likes, more than double the shares, and 64% more comments than posts without celebrities and sportspeople.

Still, regardless of the post type, communication technique, or marketing element, the researchers say, only 2% to 6% of potential customers engaged with it in some way.

Public health organizations have learned that when it comes to sharing important information, it pays to capitalize on social media. Platforms like Facebook can not only reach multitudes, but also spread a message far more widely than conventional media can. But what is the best way to leverage social media for public health messages? Researchers from University of Sydney in Australia analyzed 20 Facebook pages on skin cancer, smoking, and other public health issues to find out the most effective strategies for getting users to engage.

The researchers coded 360 days of posts for each page, ending up with 5,356 posts. They categorized the communication techniques as informative, call-to-action, instructive, positive emotive appeal, fear appeal, testimonial, and humor. They also looked at marketing elements, such as whether the page used branding, celebrities or persons of authority, mascots, competitions or giveaways, sponsorships, or vouchers and other offers.

Almost all pages were administered by a nongovernment organization. Mental health and cancer prevention were the most common public health issues. Most posts were photos; the next most common were links (but only 1% of users actually clicked on the links). The most common communication techniques were positive emotional appeal and testimonial. Fear appeal was the least common.

Video posts engaged the most users, getting the most likes and shares, the researchers say. Videos received nearly 4 times as many shares as photo posts; links and text received 30% and 69% fewer shares, respectively. Video and text-only posts received more comments than photo posts. However, the researchers add, this could reflect the Facebook algorithm, which may favor videos over other post types. They also note that only 3% of all posts they coded were videos, “suggesting that public health organizations are trailing behind conventional marketers.”

Posts with positive emotional appeal drew 18% more likes than call-to-action posts, but 27% fewer shares. Informative posts received more than twice as many shares. Fear appeal and humorous posts received more comments than call-to-action posts (perhaps because they are more controversial, the researchers suggest), and instructive posts received fewer.

Conventional marketing, such as using sponsorships or “persons of authority,” generally did not have much engagement. Celebrities and sports figures, though, got 62% more likes, more than double the shares, and 64% more comments than posts without celebrities and sportspeople.

Still, regardless of the post type, communication technique, or marketing element, the researchers say, only 2% to 6% of potential customers engaged with it in some way.

There have been 704 measles cases in the United States in 2019 as of April 26, the Centers for Disease Control and Prevention reported.

The updated figure adds 9 cases to the previous tally of 695 cases as of April 24, when the CDC announced that the number of cases in 2019 had surpassed the total for any year since the disease was considered effectively eliminated from the country in 2000.

Cases have been reported in 22 states, with the largest outbreaks in Washington and New York. The outbreak in Washington, which included 72 cases, was declared over last week. Two outbreaks in New York, however, are the largest and longest-lasting measles outbreaks since the disease was considered eliminated, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. The longer they continue, the “greater the chance that measles will again gain a foothold in the United States,” she said at CDC telebriefing on measles.

The outbreaks are linked to travelers who are exposed to measles abroad and bring it to the United States. The disease then may spread, especially in communities with high rates of unvaccinated people. “A significant factor contributing to the outbreaks in New York is misinformation in the communities about the safety of the measles/mumps/rubella vaccine,” according to the CDC.
 

National Infant Immunization Week

Until last week, 2014 – with 667 measles cases – had been the year with the most cases since the disease was effectively eliminated. The last time the United States had more measles cases was in 1994, when there were 963 cases for the year.

Health and Human Services Secretary Alex Azar, also at the telebriefing, pointed out that 1994 also was the year that the United States first observed National Infant Immunization Week, which is April 27–May 4 this year. The CDC is marking the 25th anniversary of the annual observance, which highlights “the importance of protecting infants from vaccine-preventable diseases” and celebrates “the achievements of immunization programs in promoting healthy communities,” Secretary Azar said.
 

Message to health care providers

CDC director Robert Redfield Jr., MD, noted that measles has “no treatment, no cure, and no way to predict how bad a case will be.”

Some patients may have mild symptoms, whereas others may have serious complications such as pneumonia or encephalitis. In 2019, 3% of the patients with measles have developed pneumonia, he said. No patients have died.

Dr. Redfield, a virologist, noted that the CDC is recommending that children aged 6-12 months receive 1 dose of the measles vaccine if traveling abroad.

“As CDC director and as a physician, I have and continue to wholeheartedly advocate for infant immunization,” he said in a statement. “More importantly, as a father and grandfather I have ensured all of my children and grandchildren are vaccinated on the recommended schedule. Vaccines are safe. Vaccines do not cause autism. Vaccine-preventable diseases are dangerous.”

More than 94% of parents vaccinate their children, Dr. Redfield added. “CDC is working to reach the small percentage of vaccine-hesitant individuals so they too understand the importance of vaccines. It is imperative that we correct misinformation and reassure fearful parents so they protect their children from illnesses with long-lasting health impacts.”

About 1.3%, or 100,000 children, in the United States under 2 years old have not been vaccinated, he said.

“I call upon health care providers to encourage parents and expectant parents to vaccinate their children for their own protection and to avoid the spread of vaccine-preventable diseases within their families and communities,” he said. “We must join together as a nation to once again eliminate measles and prevent future disease outbreaks.”

The CDC has a complete list of clinical recommendations for health care providers on its website.
 

The president weighs in

President Donald Trump said that children should receive vaccinations – his first public comment about vaccines since his inauguration. Previously, he had questioned the safety of vaccines.

Asked by reporters about the measles outbreaks and his message for parents about having their kids vaccinated, he said: “They have to get the shot. The vaccinations are so important. This is really going around now. They have to get their shots.”

jremaly@mdedge.com

There have been 704 measles cases in the United States in 2019 as of April 26, the Centers for Disease Control and Prevention reported.

The updated figure adds 9 cases to the previous tally of 695 cases as of April 24, when the CDC announced that the number of cases in 2019 had surpassed the total for any year since the disease was considered effectively eliminated from the country in 2000.

Cases have been reported in 22 states, with the largest outbreaks in Washington and New York. The outbreak in Washington, which included 72 cases, was declared over last week. Two outbreaks in New York, however, are the largest and longest-lasting measles outbreaks since the disease was considered eliminated, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. The longer they continue, the “greater the chance that measles will again gain a foothold in the United States,” she said at CDC telebriefing on measles.

The outbreaks are linked to travelers who are exposed to measles abroad and bring it to the United States. The disease then may spread, especially in communities with high rates of unvaccinated people. “A significant factor contributing to the outbreaks in New York is misinformation in the communities about the safety of the measles/mumps/rubella vaccine,” according to the CDC.
 

National Infant Immunization Week

Until last week, 2014 – with 667 measles cases – had been the year with the most cases since the disease was effectively eliminated. The last time the United States had more measles cases was in 1994, when there were 963 cases for the year.

Health and Human Services Secretary Alex Azar, also at the telebriefing, pointed out that 1994 also was the year that the United States first observed National Infant Immunization Week, which is April 27–May 4 this year. The CDC is marking the 25th anniversary of the annual observance, which highlights “the importance of protecting infants from vaccine-preventable diseases” and celebrates “the achievements of immunization programs in promoting healthy communities,” Secretary Azar said.
 

Message to health care providers

CDC director Robert Redfield Jr., MD, noted that measles has “no treatment, no cure, and no way to predict how bad a case will be.”

Some patients may have mild symptoms, whereas others may have serious complications such as pneumonia or encephalitis. In 2019, 3% of the patients with measles have developed pneumonia, he said. No patients have died.

Dr. Redfield, a virologist, noted that the CDC is recommending that children aged 6-12 months receive 1 dose of the measles vaccine if traveling abroad.

“As CDC director and as a physician, I have and continue to wholeheartedly advocate for infant immunization,” he said in a statement. “More importantly, as a father and grandfather I have ensured all of my children and grandchildren are vaccinated on the recommended schedule. Vaccines are safe. Vaccines do not cause autism. Vaccine-preventable diseases are dangerous.”

More than 94% of parents vaccinate their children, Dr. Redfield added. “CDC is working to reach the small percentage of vaccine-hesitant individuals so they too understand the importance of vaccines. It is imperative that we correct misinformation and reassure fearful parents so they protect their children from illnesses with long-lasting health impacts.”

About 1.3%, or 100,000 children, in the United States under 2 years old have not been vaccinated, he said.

“I call upon health care providers to encourage parents and expectant parents to vaccinate their children for their own protection and to avoid the spread of vaccine-preventable diseases within their families and communities,” he said. “We must join together as a nation to once again eliminate measles and prevent future disease outbreaks.”

The CDC has a complete list of clinical recommendations for health care providers on its website.
 

The president weighs in

President Donald Trump said that children should receive vaccinations – his first public comment about vaccines since his inauguration. Previously, he had questioned the safety of vaccines.

Asked by reporters about the measles outbreaks and his message for parents about having their kids vaccinated, he said: “They have to get the shot. The vaccinations are so important. This is really going around now. They have to get their shots.”

jremaly@mdedge.com

There have been 704 measles cases in the United States in 2019 as of April 26, the Centers for Disease Control and Prevention reported.

The updated figure adds 9 cases to the previous tally of 695 cases as of April 24, when the CDC announced that the number of cases in 2019 had surpassed the total for any year since the disease was considered effectively eliminated from the country in 2000.

Cases have been reported in 22 states, with the largest outbreaks in Washington and New York. The outbreak in Washington, which included 72 cases, was declared over last week. Two outbreaks in New York, however, are the largest and longest-lasting measles outbreaks since the disease was considered eliminated, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. The longer they continue, the “greater the chance that measles will again gain a foothold in the United States,” she said at CDC telebriefing on measles.

The outbreaks are linked to travelers who are exposed to measles abroad and bring it to the United States. The disease then may spread, especially in communities with high rates of unvaccinated people. “A significant factor contributing to the outbreaks in New York is misinformation in the communities about the safety of the measles/mumps/rubella vaccine,” according to the CDC.
 

National Infant Immunization Week

Until last week, 2014 – with 667 measles cases – had been the year with the most cases since the disease was effectively eliminated. The last time the United States had more measles cases was in 1994, when there were 963 cases for the year.

Health and Human Services Secretary Alex Azar, also at the telebriefing, pointed out that 1994 also was the year that the United States first observed National Infant Immunization Week, which is April 27–May 4 this year. The CDC is marking the 25th anniversary of the annual observance, which highlights “the importance of protecting infants from vaccine-preventable diseases” and celebrates “the achievements of immunization programs in promoting healthy communities,” Secretary Azar said.
 

Message to health care providers

CDC director Robert Redfield Jr., MD, noted that measles has “no treatment, no cure, and no way to predict how bad a case will be.”

Some patients may have mild symptoms, whereas others may have serious complications such as pneumonia or encephalitis. In 2019, 3% of the patients with measles have developed pneumonia, he said. No patients have died.

Dr. Redfield, a virologist, noted that the CDC is recommending that children aged 6-12 months receive 1 dose of the measles vaccine if traveling abroad.

“As CDC director and as a physician, I have and continue to wholeheartedly advocate for infant immunization,” he said in a statement. “More importantly, as a father and grandfather I have ensured all of my children and grandchildren are vaccinated on the recommended schedule. Vaccines are safe. Vaccines do not cause autism. Vaccine-preventable diseases are dangerous.”

More than 94% of parents vaccinate their children, Dr. Redfield added. “CDC is working to reach the small percentage of vaccine-hesitant individuals so they too understand the importance of vaccines. It is imperative that we correct misinformation and reassure fearful parents so they protect their children from illnesses with long-lasting health impacts.”

About 1.3%, or 100,000 children, in the United States under 2 years old have not been vaccinated, he said.

“I call upon health care providers to encourage parents and expectant parents to vaccinate their children for their own protection and to avoid the spread of vaccine-preventable diseases within their families and communities,” he said. “We must join together as a nation to once again eliminate measles and prevent future disease outbreaks.”

The CDC has a complete list of clinical recommendations for health care providers on its website.
 

The president weighs in

President Donald Trump said that children should receive vaccinations – his first public comment about vaccines since his inauguration. Previously, he had questioned the safety of vaccines.

Asked by reporters about the measles outbreaks and his message for parents about having their kids vaccinated, he said: “They have to get the shot. The vaccinations are so important. This is really going around now. They have to get their shots.”

jremaly@mdedge.com