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Can a novel steroidal anti-inflammatory drug benefit patients with Duchenne muscular dystrophy?
Daily treatment with vamorolone at doses of 2.0 mg/kg per day and 6.0 mg/kg per day suggested possible efficacy in a 24-week study, researchers said. The exploratory study included 48 boys who had completed a phase 2a trial.
The treatment was safe and well tolerated, and patients who received 2.0 mg/kg per day had significantly improved muscle function, as assessed by time to stand, compared with natural history controls, according to the results, which were published in Neurology.
In addition, the novel drug may reduce “safety concerns typically seen with traditional glucocorticoids,” wrote Eric P. Hoffman, PhD, and coauthors. Dr. Hoffman is president and CEO of ReveraGen BioPharma in Rockville, Md., which is developing the drug, and associate dean for research in the school of pharmacy and pharmaceutical sciences at Binghamton (N.Y.) University.
In preclinical studies, vamorolone retained anti-inflammatory efficacy while reducing adverse effects, compared with prednisolone, in a manner that is “consistent with vamorolone blocking [nuclear factor-kappa beta]–associated proinflammatory signals as a ligand/receptor monomeric state instead of the traditional molecular models of ligand/receptor dimeric complexes,” the authors said.
Phase 1 and phase 2a studies suggest that the drug may have an improved safety profile. To assess possible efficacy and define optimal doses, the investigators conducted the 24-week extension study. Participants were boys aged 4 years to younger than 7 years who had never been treated with glucocorticoids. They received 0.25, 0.75, 2.0, or 6.0 mg/kg per day vamorolone in an oral suspension formulation. Twelve boys received each dose level.
“Vamorolone was well tolerated ... with no adverse events leading to reduction of drug dosing or withdrawal from the trial,” they said. “The [timed stand from supine] primary outcome measure in vamorolone-treated patients with DMD supports efficacy of the 2.0-mg/kg/d dose ... at 24 weeks,” they said. A secondary outcome measure, the 6-minute walk test, supports efficacy at this dose at 12 and 24 weeks of treatment.
Furthermore, the data indicate that the 2.0-mg/kg per day dose may be associated with less weight gain and improved bone turnover and insulin resistance biomarkers, relative to prednisone therapy. “There was evidence of adrenal suppression in a subset of boys with DMD treated with 2.0 mg/kg/d vamorolone, with 18% of patients showing reduced morning cortisol levels,” the authors said. “Future studies of vamorolone will include adrenocorticotropic hormone–challenge tests to further explore adrenal function.”
A double-blind, placebo-controlled trial of vamorolone is underway. Investigators are testing two doses of vamorolone (2.0 and 6.0 mg/kg per day) versus placebo and prednisone (0.75 mg/kg per day). Researchers plan to enroll 120 patients, with 30 patients in each arm.
ReveraGen BioPharma received funds for the present study from Actelion Pharmaceuticals, U.S. and European government agencies, and nonprofit foundations. Dr. Hoffman and some of his collaborators are cofounders of ReveraGen. Other coauthors received support from the company.
SOURCE: Hoffman EP et al. Neurology. 2019 Aug 26. doi: 10.1212/WNL.0000000000008168.
Daily treatment with vamorolone at doses of 2.0 mg/kg per day and 6.0 mg/kg per day suggested possible efficacy in a 24-week study, researchers said. The exploratory study included 48 boys who had completed a phase 2a trial.
The treatment was safe and well tolerated, and patients who received 2.0 mg/kg per day had significantly improved muscle function, as assessed by time to stand, compared with natural history controls, according to the results, which were published in Neurology.
In addition, the novel drug may reduce “safety concerns typically seen with traditional glucocorticoids,” wrote Eric P. Hoffman, PhD, and coauthors. Dr. Hoffman is president and CEO of ReveraGen BioPharma in Rockville, Md., which is developing the drug, and associate dean for research in the school of pharmacy and pharmaceutical sciences at Binghamton (N.Y.) University.
In preclinical studies, vamorolone retained anti-inflammatory efficacy while reducing adverse effects, compared with prednisolone, in a manner that is “consistent with vamorolone blocking [nuclear factor-kappa beta]–associated proinflammatory signals as a ligand/receptor monomeric state instead of the traditional molecular models of ligand/receptor dimeric complexes,” the authors said.
Phase 1 and phase 2a studies suggest that the drug may have an improved safety profile. To assess possible efficacy and define optimal doses, the investigators conducted the 24-week extension study. Participants were boys aged 4 years to younger than 7 years who had never been treated with glucocorticoids. They received 0.25, 0.75, 2.0, or 6.0 mg/kg per day vamorolone in an oral suspension formulation. Twelve boys received each dose level.
“Vamorolone was well tolerated ... with no adverse events leading to reduction of drug dosing or withdrawal from the trial,” they said. “The [timed stand from supine] primary outcome measure in vamorolone-treated patients with DMD supports efficacy of the 2.0-mg/kg/d dose ... at 24 weeks,” they said. A secondary outcome measure, the 6-minute walk test, supports efficacy at this dose at 12 and 24 weeks of treatment.
Furthermore, the data indicate that the 2.0-mg/kg per day dose may be associated with less weight gain and improved bone turnover and insulin resistance biomarkers, relative to prednisone therapy. “There was evidence of adrenal suppression in a subset of boys with DMD treated with 2.0 mg/kg/d vamorolone, with 18% of patients showing reduced morning cortisol levels,” the authors said. “Future studies of vamorolone will include adrenocorticotropic hormone–challenge tests to further explore adrenal function.”
A double-blind, placebo-controlled trial of vamorolone is underway. Investigators are testing two doses of vamorolone (2.0 and 6.0 mg/kg per day) versus placebo and prednisone (0.75 mg/kg per day). Researchers plan to enroll 120 patients, with 30 patients in each arm.
ReveraGen BioPharma received funds for the present study from Actelion Pharmaceuticals, U.S. and European government agencies, and nonprofit foundations. Dr. Hoffman and some of his collaborators are cofounders of ReveraGen. Other coauthors received support from the company.
SOURCE: Hoffman EP et al. Neurology. 2019 Aug 26. doi: 10.1212/WNL.0000000000008168.
Daily treatment with vamorolone at doses of 2.0 mg/kg per day and 6.0 mg/kg per day suggested possible efficacy in a 24-week study, researchers said. The exploratory study included 48 boys who had completed a phase 2a trial.
The treatment was safe and well tolerated, and patients who received 2.0 mg/kg per day had significantly improved muscle function, as assessed by time to stand, compared with natural history controls, according to the results, which were published in Neurology.
In addition, the novel drug may reduce “safety concerns typically seen with traditional glucocorticoids,” wrote Eric P. Hoffman, PhD, and coauthors. Dr. Hoffman is president and CEO of ReveraGen BioPharma in Rockville, Md., which is developing the drug, and associate dean for research in the school of pharmacy and pharmaceutical sciences at Binghamton (N.Y.) University.
In preclinical studies, vamorolone retained anti-inflammatory efficacy while reducing adverse effects, compared with prednisolone, in a manner that is “consistent with vamorolone blocking [nuclear factor-kappa beta]–associated proinflammatory signals as a ligand/receptor monomeric state instead of the traditional molecular models of ligand/receptor dimeric complexes,” the authors said.
Phase 1 and phase 2a studies suggest that the drug may have an improved safety profile. To assess possible efficacy and define optimal doses, the investigators conducted the 24-week extension study. Participants were boys aged 4 years to younger than 7 years who had never been treated with glucocorticoids. They received 0.25, 0.75, 2.0, or 6.0 mg/kg per day vamorolone in an oral suspension formulation. Twelve boys received each dose level.
“Vamorolone was well tolerated ... with no adverse events leading to reduction of drug dosing or withdrawal from the trial,” they said. “The [timed stand from supine] primary outcome measure in vamorolone-treated patients with DMD supports efficacy of the 2.0-mg/kg/d dose ... at 24 weeks,” they said. A secondary outcome measure, the 6-minute walk test, supports efficacy at this dose at 12 and 24 weeks of treatment.
Furthermore, the data indicate that the 2.0-mg/kg per day dose may be associated with less weight gain and improved bone turnover and insulin resistance biomarkers, relative to prednisone therapy. “There was evidence of adrenal suppression in a subset of boys with DMD treated with 2.0 mg/kg/d vamorolone, with 18% of patients showing reduced morning cortisol levels,” the authors said. “Future studies of vamorolone will include adrenocorticotropic hormone–challenge tests to further explore adrenal function.”
A double-blind, placebo-controlled trial of vamorolone is underway. Investigators are testing two doses of vamorolone (2.0 and 6.0 mg/kg per day) versus placebo and prednisone (0.75 mg/kg per day). Researchers plan to enroll 120 patients, with 30 patients in each arm.
ReveraGen BioPharma received funds for the present study from Actelion Pharmaceuticals, U.S. and European government agencies, and nonprofit foundations. Dr. Hoffman and some of his collaborators are cofounders of ReveraGen. Other coauthors received support from the company.
SOURCE: Hoffman EP et al. Neurology. 2019 Aug 26. doi: 10.1212/WNL.0000000000008168.
FROM NEUROLOGY
Be alert to deep SSI risk after knee surgery
Deep surgical-site infections (SSIs) and septic arthritis are not uncommon after the surgeries for periarticular knee fractures, a meta-analysis of existing research found.
A smaller analysis of 1,567 patients found that 2.4% had septic arthritis. “Surgeons managing periarticular knee fractures should be vigilant when wounds are not pristine,” the investigators recommended.
The report, which appeared in JAMA Network Open, was led by premed student Grayson R. Norris of High Point (N.C.) University.
The researchers noted that there are widely variable statistics regarding SSI after surgery for periarticular knee fractures. A better understanding of the risk would help orthopedic surgeons, given the mortality risk and extra costs associated with postoperative deep SSIs.
For the analysis, the researchers reviewed 117 studies with 11,432 patients who had fractures in the tibial plateau (61% of studies), distal femur (14%), proximal tibia (11%), patella (9%), and multiple sites (6%). More than two-thirds of the studies were retrospective.
Overall, 5.7% of patients suffered deep SSIs, with the highest percentage in the proximal tibia group (6.4%).
A total of 20 studies examined septic arthritis and found that 2.4% of patients in those studies suffered from the condition. Of 182 cases of deep SSIs with bacterial culture results, methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-susceptible S. aureus were the most common bacteria.
“Considering that MRSA was the most common pathogen in our study and that this pathogen is increasing in prevalence, health care practitioners should revisit the use of specific and appropriate prophylactic antibiotics,” the researchers wrote. “Risk factors, such as open fractures, diabetes, smoking, and, most importantly, compartment syndrome, should alert the treating surgeon to an increased risk. Further work is needed to mitigate the association of these conditions with SSI risk in periarticular knee fractures.”
The researchers added that many of the studies in their analysis were of poor quality. “Authors in orthopedic traumatology should strive to conduct higher-quality research, such as randomized clinical trials and case-control or cohort studies,” they noted.
One author reported receiving grants from Zimmer Biomet and DePuy Synthes outside the submitted work. No other disclosures were reported. No study funding was reported.
SOURCE: Norris GR et al. JAMA Netw Open. 2019;2(8):e199951.
Deep surgical-site infections (SSIs) and septic arthritis are not uncommon after the surgeries for periarticular knee fractures, a meta-analysis of existing research found.
A smaller analysis of 1,567 patients found that 2.4% had septic arthritis. “Surgeons managing periarticular knee fractures should be vigilant when wounds are not pristine,” the investigators recommended.
The report, which appeared in JAMA Network Open, was led by premed student Grayson R. Norris of High Point (N.C.) University.
The researchers noted that there are widely variable statistics regarding SSI after surgery for periarticular knee fractures. A better understanding of the risk would help orthopedic surgeons, given the mortality risk and extra costs associated with postoperative deep SSIs.
For the analysis, the researchers reviewed 117 studies with 11,432 patients who had fractures in the tibial plateau (61% of studies), distal femur (14%), proximal tibia (11%), patella (9%), and multiple sites (6%). More than two-thirds of the studies were retrospective.
Overall, 5.7% of patients suffered deep SSIs, with the highest percentage in the proximal tibia group (6.4%).
A total of 20 studies examined septic arthritis and found that 2.4% of patients in those studies suffered from the condition. Of 182 cases of deep SSIs with bacterial culture results, methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-susceptible S. aureus were the most common bacteria.
“Considering that MRSA was the most common pathogen in our study and that this pathogen is increasing in prevalence, health care practitioners should revisit the use of specific and appropriate prophylactic antibiotics,” the researchers wrote. “Risk factors, such as open fractures, diabetes, smoking, and, most importantly, compartment syndrome, should alert the treating surgeon to an increased risk. Further work is needed to mitigate the association of these conditions with SSI risk in periarticular knee fractures.”
The researchers added that many of the studies in their analysis were of poor quality. “Authors in orthopedic traumatology should strive to conduct higher-quality research, such as randomized clinical trials and case-control or cohort studies,” they noted.
One author reported receiving grants from Zimmer Biomet and DePuy Synthes outside the submitted work. No other disclosures were reported. No study funding was reported.
SOURCE: Norris GR et al. JAMA Netw Open. 2019;2(8):e199951.
Deep surgical-site infections (SSIs) and septic arthritis are not uncommon after the surgeries for periarticular knee fractures, a meta-analysis of existing research found.
A smaller analysis of 1,567 patients found that 2.4% had septic arthritis. “Surgeons managing periarticular knee fractures should be vigilant when wounds are not pristine,” the investigators recommended.
The report, which appeared in JAMA Network Open, was led by premed student Grayson R. Norris of High Point (N.C.) University.
The researchers noted that there are widely variable statistics regarding SSI after surgery for periarticular knee fractures. A better understanding of the risk would help orthopedic surgeons, given the mortality risk and extra costs associated with postoperative deep SSIs.
For the analysis, the researchers reviewed 117 studies with 11,432 patients who had fractures in the tibial plateau (61% of studies), distal femur (14%), proximal tibia (11%), patella (9%), and multiple sites (6%). More than two-thirds of the studies were retrospective.
Overall, 5.7% of patients suffered deep SSIs, with the highest percentage in the proximal tibia group (6.4%).
A total of 20 studies examined septic arthritis and found that 2.4% of patients in those studies suffered from the condition. Of 182 cases of deep SSIs with bacterial culture results, methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-susceptible S. aureus were the most common bacteria.
“Considering that MRSA was the most common pathogen in our study and that this pathogen is increasing in prevalence, health care practitioners should revisit the use of specific and appropriate prophylactic antibiotics,” the researchers wrote. “Risk factors, such as open fractures, diabetes, smoking, and, most importantly, compartment syndrome, should alert the treating surgeon to an increased risk. Further work is needed to mitigate the association of these conditions with SSI risk in periarticular knee fractures.”
The researchers added that many of the studies in their analysis were of poor quality. “Authors in orthopedic traumatology should strive to conduct higher-quality research, such as randomized clinical trials and case-control or cohort studies,” they noted.
One author reported receiving grants from Zimmer Biomet and DePuy Synthes outside the submitted work. No other disclosures were reported. No study funding was reported.
SOURCE: Norris GR et al. JAMA Netw Open. 2019;2(8):e199951.
FROM JAMA NETWORK OPEN
Latest suicide prevention research highlights roles for clinicians, teachers, and parents
Joan Asarnow, PhD, said in a webinar presented on World Suicide Prevention Day, Sept. 10, 2019, to raise awareness of the latest research in suicide prevention and risk factors.
“Primary care doctors are the most trusted doctors for our teenagers,” Dr. Asarnow said during a question-and-answer session. Primary care can be the first-line screening to identify risk factors for suicide, and a close link with primary care “can make a very big difference in helping kids get through tough times.”
Other studies have shown that when doctors and nurses are able to recognize suicidality and link to behavioral health when needed, suicide attempts and ideation are reduced. Strategies including dialectical behavioral therapy and cognitive-behavior therapy have demonstrated success in reducing self -harm, she noted.
Schools have a role in suicide prevention as well, said Dr. Asarnow of the University of California, Los Angeles, and editor of a special issue of the Journal of Child Psychology and Psychiatry on suicide and self-harm.
She cited data from the Saving and Empowering Young Lives in Europe (SEYLE) study, a longitudinal study of school-based suicide prevention interventions, in which suicide attempts were significantly lower among teens who were exposed to a school-based program (Youth Aware of Mental Health) than they were among controls.
Additional findings from the SEYLE study recently were published in the Journal of Child Psychology and Psychiatry (2019. doi: 10.1111/jcpp.13119).
The authors investigated the interaction of three interventions with a certain model of suicide risk. The three interventions were Youth Aware of Mental Health (YAM); Question, Persuade and Refer (QPR); and ProfScreen. The latter two are established interventions for use by teachers. In the study, 11,110 high school students from 10 countries in the European Union completed questionnaires to assess baseline feelings of being a burden to others and feelings of loneliness and isolation from family and peers. The questionnaires also assessed health risk behaviors, self-injury, suicide ideation, and suicide attempts (SA), which were factors in the model being investigated. The participants were randomized to one of the interventions or to a control group that received educational posters with information about mental health resources.
In a reassessment of 8,972 adolescents 12 months later, the interventions all significantly reduced the association between repeated suicide attempts and the baseline interaction of self-injury and suicide ideation, compared with the control group.
“Among each of the three intervention groups, [suicide ideation] at baseline did not increase the risk of self-injury to be associated with repeated [suicide attempt]” at follow-up, Shira Barzilay, PhD, of Tel Aviv University, and coauthors said.
In addition, the researchers’ model found that “belongingness to parents” predicted lower odds of SI after controlling for depression, anxiety, and internalizing symptoms, and this prediction was similar across the intervention and control groups, although good relations with peers and lack of feeling like a burden on others were not significantly associated with lower odds of SI.
The study findings were limited by several factors including the limits of the model to fully capture the measures of belongingness or burdensomeness, and the use of a 12-month follow-up, which was too long to examine certain patterns of SA, the researchers noted. However, the results suggest that interventions can help reduce risk behaviors or self-harm that could lead to suicide. Areas for further study include examining spikes in risk variables that might have preceded suicide attempts, elevated stress, or interpersonal conflicts.
“The implications for suicide prevention, in both community and clinical settings, are to monitor youth who may be engaged in risky behaviors regardless of [suicide ideation] presentation and provide them with mental health education,” Dr. Barzilay and coauthors concluded.
The ongoing mission, Dr. Asarnow said, is “to send messages of hope, and that there is help out there.”
This is particularly important in the United States and the United Kingdom because, while suicide rates in adolescents have declined in some countries, they have increased in others, notably the two countries aforementioned, Dennis Ougrin, MD, said at the webinar.
Males are more likely to commit suicide than females by a ratio of 3 or 4 to 1 in most Western countries, said Dr. Ougrin, a child and adolescent psychiatrist at South London and Maudsley National Health Service Foundation Trust, leading the Child and Adolescent Mental Health Services Enhanced Treatment Service.
Although hanging is the most common method for suicides in most countries, followed by poisoning, more than 50% of suicides in the United States are caused by firearms, he noted.
Risk factors for completed suicide include male sex, low social status, restricted educational achievement, parental mental disorder, individual mental disorder, family history of suicidal behavior, problems with interpersonal relationships, drug and alcohol misuse, and feelings of hopelessness, said Dr. Ougrin, citing data from a 2012 study published in the Lancet (2012 Jun 23. doi: 10.1016/S0140-6736[12]60322-5).
The webinar was sponsored by Wiley partnership with the World Federation of Science Journalists and the Association of Health Care Journalists. Dr. Asarnow and Dr. Ougrin had no financial conflicts to disclose. The SEYLE project is supported by the European Union through the Seventh Framework Program. Dr. Barzilay and coauthors of the SEYLE study had no financial conflicts to disclose.
Joan Asarnow, PhD, said in a webinar presented on World Suicide Prevention Day, Sept. 10, 2019, to raise awareness of the latest research in suicide prevention and risk factors.
“Primary care doctors are the most trusted doctors for our teenagers,” Dr. Asarnow said during a question-and-answer session. Primary care can be the first-line screening to identify risk factors for suicide, and a close link with primary care “can make a very big difference in helping kids get through tough times.”
Other studies have shown that when doctors and nurses are able to recognize suicidality and link to behavioral health when needed, suicide attempts and ideation are reduced. Strategies including dialectical behavioral therapy and cognitive-behavior therapy have demonstrated success in reducing self -harm, she noted.
Schools have a role in suicide prevention as well, said Dr. Asarnow of the University of California, Los Angeles, and editor of a special issue of the Journal of Child Psychology and Psychiatry on suicide and self-harm.
She cited data from the Saving and Empowering Young Lives in Europe (SEYLE) study, a longitudinal study of school-based suicide prevention interventions, in which suicide attempts were significantly lower among teens who were exposed to a school-based program (Youth Aware of Mental Health) than they were among controls.
Additional findings from the SEYLE study recently were published in the Journal of Child Psychology and Psychiatry (2019. doi: 10.1111/jcpp.13119).
The authors investigated the interaction of three interventions with a certain model of suicide risk. The three interventions were Youth Aware of Mental Health (YAM); Question, Persuade and Refer (QPR); and ProfScreen. The latter two are established interventions for use by teachers. In the study, 11,110 high school students from 10 countries in the European Union completed questionnaires to assess baseline feelings of being a burden to others and feelings of loneliness and isolation from family and peers. The questionnaires also assessed health risk behaviors, self-injury, suicide ideation, and suicide attempts (SA), which were factors in the model being investigated. The participants were randomized to one of the interventions or to a control group that received educational posters with information about mental health resources.
In a reassessment of 8,972 adolescents 12 months later, the interventions all significantly reduced the association between repeated suicide attempts and the baseline interaction of self-injury and suicide ideation, compared with the control group.
“Among each of the three intervention groups, [suicide ideation] at baseline did not increase the risk of self-injury to be associated with repeated [suicide attempt]” at follow-up, Shira Barzilay, PhD, of Tel Aviv University, and coauthors said.
In addition, the researchers’ model found that “belongingness to parents” predicted lower odds of SI after controlling for depression, anxiety, and internalizing symptoms, and this prediction was similar across the intervention and control groups, although good relations with peers and lack of feeling like a burden on others were not significantly associated with lower odds of SI.
The study findings were limited by several factors including the limits of the model to fully capture the measures of belongingness or burdensomeness, and the use of a 12-month follow-up, which was too long to examine certain patterns of SA, the researchers noted. However, the results suggest that interventions can help reduce risk behaviors or self-harm that could lead to suicide. Areas for further study include examining spikes in risk variables that might have preceded suicide attempts, elevated stress, or interpersonal conflicts.
“The implications for suicide prevention, in both community and clinical settings, are to monitor youth who may be engaged in risky behaviors regardless of [suicide ideation] presentation and provide them with mental health education,” Dr. Barzilay and coauthors concluded.
The ongoing mission, Dr. Asarnow said, is “to send messages of hope, and that there is help out there.”
This is particularly important in the United States and the United Kingdom because, while suicide rates in adolescents have declined in some countries, they have increased in others, notably the two countries aforementioned, Dennis Ougrin, MD, said at the webinar.
Males are more likely to commit suicide than females by a ratio of 3 or 4 to 1 in most Western countries, said Dr. Ougrin, a child and adolescent psychiatrist at South London and Maudsley National Health Service Foundation Trust, leading the Child and Adolescent Mental Health Services Enhanced Treatment Service.
Although hanging is the most common method for suicides in most countries, followed by poisoning, more than 50% of suicides in the United States are caused by firearms, he noted.
Risk factors for completed suicide include male sex, low social status, restricted educational achievement, parental mental disorder, individual mental disorder, family history of suicidal behavior, problems with interpersonal relationships, drug and alcohol misuse, and feelings of hopelessness, said Dr. Ougrin, citing data from a 2012 study published in the Lancet (2012 Jun 23. doi: 10.1016/S0140-6736[12]60322-5).
The webinar was sponsored by Wiley partnership with the World Federation of Science Journalists and the Association of Health Care Journalists. Dr. Asarnow and Dr. Ougrin had no financial conflicts to disclose. The SEYLE project is supported by the European Union through the Seventh Framework Program. Dr. Barzilay and coauthors of the SEYLE study had no financial conflicts to disclose.
Joan Asarnow, PhD, said in a webinar presented on World Suicide Prevention Day, Sept. 10, 2019, to raise awareness of the latest research in suicide prevention and risk factors.
“Primary care doctors are the most trusted doctors for our teenagers,” Dr. Asarnow said during a question-and-answer session. Primary care can be the first-line screening to identify risk factors for suicide, and a close link with primary care “can make a very big difference in helping kids get through tough times.”
Other studies have shown that when doctors and nurses are able to recognize suicidality and link to behavioral health when needed, suicide attempts and ideation are reduced. Strategies including dialectical behavioral therapy and cognitive-behavior therapy have demonstrated success in reducing self -harm, she noted.
Schools have a role in suicide prevention as well, said Dr. Asarnow of the University of California, Los Angeles, and editor of a special issue of the Journal of Child Psychology and Psychiatry on suicide and self-harm.
She cited data from the Saving and Empowering Young Lives in Europe (SEYLE) study, a longitudinal study of school-based suicide prevention interventions, in which suicide attempts were significantly lower among teens who were exposed to a school-based program (Youth Aware of Mental Health) than they were among controls.
Additional findings from the SEYLE study recently were published in the Journal of Child Psychology and Psychiatry (2019. doi: 10.1111/jcpp.13119).
The authors investigated the interaction of three interventions with a certain model of suicide risk. The three interventions were Youth Aware of Mental Health (YAM); Question, Persuade and Refer (QPR); and ProfScreen. The latter two are established interventions for use by teachers. In the study, 11,110 high school students from 10 countries in the European Union completed questionnaires to assess baseline feelings of being a burden to others and feelings of loneliness and isolation from family and peers. The questionnaires also assessed health risk behaviors, self-injury, suicide ideation, and suicide attempts (SA), which were factors in the model being investigated. The participants were randomized to one of the interventions or to a control group that received educational posters with information about mental health resources.
In a reassessment of 8,972 adolescents 12 months later, the interventions all significantly reduced the association between repeated suicide attempts and the baseline interaction of self-injury and suicide ideation, compared with the control group.
“Among each of the three intervention groups, [suicide ideation] at baseline did not increase the risk of self-injury to be associated with repeated [suicide attempt]” at follow-up, Shira Barzilay, PhD, of Tel Aviv University, and coauthors said.
In addition, the researchers’ model found that “belongingness to parents” predicted lower odds of SI after controlling for depression, anxiety, and internalizing symptoms, and this prediction was similar across the intervention and control groups, although good relations with peers and lack of feeling like a burden on others were not significantly associated with lower odds of SI.
The study findings were limited by several factors including the limits of the model to fully capture the measures of belongingness or burdensomeness, and the use of a 12-month follow-up, which was too long to examine certain patterns of SA, the researchers noted. However, the results suggest that interventions can help reduce risk behaviors or self-harm that could lead to suicide. Areas for further study include examining spikes in risk variables that might have preceded suicide attempts, elevated stress, or interpersonal conflicts.
“The implications for suicide prevention, in both community and clinical settings, are to monitor youth who may be engaged in risky behaviors regardless of [suicide ideation] presentation and provide them with mental health education,” Dr. Barzilay and coauthors concluded.
The ongoing mission, Dr. Asarnow said, is “to send messages of hope, and that there is help out there.”
This is particularly important in the United States and the United Kingdom because, while suicide rates in adolescents have declined in some countries, they have increased in others, notably the two countries aforementioned, Dennis Ougrin, MD, said at the webinar.
Males are more likely to commit suicide than females by a ratio of 3 or 4 to 1 in most Western countries, said Dr. Ougrin, a child and adolescent psychiatrist at South London and Maudsley National Health Service Foundation Trust, leading the Child and Adolescent Mental Health Services Enhanced Treatment Service.
Although hanging is the most common method for suicides in most countries, followed by poisoning, more than 50% of suicides in the United States are caused by firearms, he noted.
Risk factors for completed suicide include male sex, low social status, restricted educational achievement, parental mental disorder, individual mental disorder, family history of suicidal behavior, problems with interpersonal relationships, drug and alcohol misuse, and feelings of hopelessness, said Dr. Ougrin, citing data from a 2012 study published in the Lancet (2012 Jun 23. doi: 10.1016/S0140-6736[12]60322-5).
The webinar was sponsored by Wiley partnership with the World Federation of Science Journalists and the Association of Health Care Journalists. Dr. Asarnow and Dr. Ougrin had no financial conflicts to disclose. The SEYLE project is supported by the European Union through the Seventh Framework Program. Dr. Barzilay and coauthors of the SEYLE study had no financial conflicts to disclose.
FROM A SCIENCE TALKS WEBINAR
When Life’s an Itch
A 34-year-old woman self-refers to dermatology for evaluation of a very itchy rash that manifested 2 weeks ago on her right arm. She immediately went to an urgent care clinic, where she was diagnosed with shingles and prescribed valacyclovir. This diagnosis was upsetting to the patient, as she was advised to avoid contact with her newborn niece for at least 2 weeks.
Despite the prescribed medication, however, the rash began to pop up in other areas, including her left arm, chest, and face. Through all of this, the patient felt fine: no fever, myalgia, or malaise.
Her husband suggested she seek an appointment with dermatology, which was expedited by a phone call from her primary care provider.
EXAMINATION
The patient is afebrile and in no acute distress. She is, however, quite upset with the widespread collections of vesicles on mildly erythematous bases, many in a linear configuration. In several areas, there is ecchymosis secondary to scratching.
What’s the diagnosis?
DISCUSSION
Poison ivy, or Rhus dermatitis, is one of the most common dermatologic problems seen in medicine—and yet, its various presentations can, as this case illustrates, be quite confusing. Even when it is recognized, treatment is far from satisfactory (but more on that later). Furthermore, there is a lot of misinformation about everything from the appearance of the offending plant to the condition’s “contagious” nature.
From a broader perspective, poison ivy is becoming more prevalent and its effects more pronounced as cities expand into formerly open country. The Rhus plant family (Toxicodendron radicans and others) thrives on our increasing levels of CO2, effectively making the “poisonous” resin in the stems, leaves, and berries more potent.
With repeated exposure, the vast majority of the population will develop an allergy to this resin, known as urushiol, which can persist even on long-dead plants, vines, and leaves. (It does take repeated exposure to develop the requisite T-cell population, which is why many children are immune to it.) The urushiol does not serve as a protective substance for the plant; rather, it helps the plant retain water. In fact, many animals feed on the plant with impunity.
Virtually all members of the poison ivy family display “leaves of three” emerging from a single stem, with each triplet alternating first on one side of the branch and then on the other. Several varieties of the plant flourish over vast areas of the world, but in the United States, east of the Rockies, Toxicodendron radicans is the dominant member of the family. It can grow as a low vine, a shrub, or a climbing vine, each with a distinct appearance aside from the leaves, which are almond-shaped, smooth, and usually shiny with smooth surfaces. Most mature leaves will have a single notch, sometimes called a “thumb,” on otherwise smooth, nonserrated edges. In the summer, tiny white and yellow berries begin to grow.
The climbing vines of older plants can reach heights of 10 meters or more. These vines can reach a thickness of 3 inches and often appear “furry,” with tiny rootlets covering their surfaces. Plants this large can produce leaves 12 to 14 inches long.
Clinically, the appearance of linear pink to red pruritic vesicular streaks typify this contact dermatitis, which can immediately follow exposure or take days to appear. Said exposure can be direct or via pets, tools, or aerosols (eg, from neighbors mowing their lawns). Besides avoidance of the great outdoors, washing thoroughly immediately after exposure makes sense (but many are unaware that they’ve been exposed until it’s too late).
Poison ivy is not contagious, though the general public firmly believes otherwise. Left untreated, it clears within 2 weeks (except in unusual cases). For those who cannot bear to wait, treatment is problematic, to say the least. OTC products, such as calamine lotion, do nothing for the itching but may help with blistering. Topical or systemic steroids reduce itching somewhat. Antihistamines are useless, since this condition does not involve histamine release.
TAKE-HOME LEARNING POINTS
- Poison ivy (Rhus dermatitis) is quite common and becoming more so due to encroaching civilization and increasing CO2 levels.
- “Leaves of three, let it be” is still good advice, because the poison ivy plant Toxicodendron radicans manifests with three almond-shaped, shiny, green leaves grouped in threes.
- Urushiol is the name of the oily resin found in the plant’s stem, leaves, and berries, and is the trigger resulting in contact dermatitis.
- Poison ivy is not contagious and typically clears in 2 weeks.
A 34-year-old woman self-refers to dermatology for evaluation of a very itchy rash that manifested 2 weeks ago on her right arm. She immediately went to an urgent care clinic, where she was diagnosed with shingles and prescribed valacyclovir. This diagnosis was upsetting to the patient, as she was advised to avoid contact with her newborn niece for at least 2 weeks.
Despite the prescribed medication, however, the rash began to pop up in other areas, including her left arm, chest, and face. Through all of this, the patient felt fine: no fever, myalgia, or malaise.
Her husband suggested she seek an appointment with dermatology, which was expedited by a phone call from her primary care provider.
EXAMINATION
The patient is afebrile and in no acute distress. She is, however, quite upset with the widespread collections of vesicles on mildly erythematous bases, many in a linear configuration. In several areas, there is ecchymosis secondary to scratching.
What’s the diagnosis?
DISCUSSION
Poison ivy, or Rhus dermatitis, is one of the most common dermatologic problems seen in medicine—and yet, its various presentations can, as this case illustrates, be quite confusing. Even when it is recognized, treatment is far from satisfactory (but more on that later). Furthermore, there is a lot of misinformation about everything from the appearance of the offending plant to the condition’s “contagious” nature.
From a broader perspective, poison ivy is becoming more prevalent and its effects more pronounced as cities expand into formerly open country. The Rhus plant family (Toxicodendron radicans and others) thrives on our increasing levels of CO2, effectively making the “poisonous” resin in the stems, leaves, and berries more potent.
With repeated exposure, the vast majority of the population will develop an allergy to this resin, known as urushiol, which can persist even on long-dead plants, vines, and leaves. (It does take repeated exposure to develop the requisite T-cell population, which is why many children are immune to it.) The urushiol does not serve as a protective substance for the plant; rather, it helps the plant retain water. In fact, many animals feed on the plant with impunity.
Virtually all members of the poison ivy family display “leaves of three” emerging from a single stem, with each triplet alternating first on one side of the branch and then on the other. Several varieties of the plant flourish over vast areas of the world, but in the United States, east of the Rockies, Toxicodendron radicans is the dominant member of the family. It can grow as a low vine, a shrub, or a climbing vine, each with a distinct appearance aside from the leaves, which are almond-shaped, smooth, and usually shiny with smooth surfaces. Most mature leaves will have a single notch, sometimes called a “thumb,” on otherwise smooth, nonserrated edges. In the summer, tiny white and yellow berries begin to grow.
The climbing vines of older plants can reach heights of 10 meters or more. These vines can reach a thickness of 3 inches and often appear “furry,” with tiny rootlets covering their surfaces. Plants this large can produce leaves 12 to 14 inches long.
Clinically, the appearance of linear pink to red pruritic vesicular streaks typify this contact dermatitis, which can immediately follow exposure or take days to appear. Said exposure can be direct or via pets, tools, or aerosols (eg, from neighbors mowing their lawns). Besides avoidance of the great outdoors, washing thoroughly immediately after exposure makes sense (but many are unaware that they’ve been exposed until it’s too late).
Poison ivy is not contagious, though the general public firmly believes otherwise. Left untreated, it clears within 2 weeks (except in unusual cases). For those who cannot bear to wait, treatment is problematic, to say the least. OTC products, such as calamine lotion, do nothing for the itching but may help with blistering. Topical or systemic steroids reduce itching somewhat. Antihistamines are useless, since this condition does not involve histamine release.
TAKE-HOME LEARNING POINTS
- Poison ivy (Rhus dermatitis) is quite common and becoming more so due to encroaching civilization and increasing CO2 levels.
- “Leaves of three, let it be” is still good advice, because the poison ivy plant Toxicodendron radicans manifests with three almond-shaped, shiny, green leaves grouped in threes.
- Urushiol is the name of the oily resin found in the plant’s stem, leaves, and berries, and is the trigger resulting in contact dermatitis.
- Poison ivy is not contagious and typically clears in 2 weeks.
A 34-year-old woman self-refers to dermatology for evaluation of a very itchy rash that manifested 2 weeks ago on her right arm. She immediately went to an urgent care clinic, where she was diagnosed with shingles and prescribed valacyclovir. This diagnosis was upsetting to the patient, as she was advised to avoid contact with her newborn niece for at least 2 weeks.
Despite the prescribed medication, however, the rash began to pop up in other areas, including her left arm, chest, and face. Through all of this, the patient felt fine: no fever, myalgia, or malaise.
Her husband suggested she seek an appointment with dermatology, which was expedited by a phone call from her primary care provider.
EXAMINATION
The patient is afebrile and in no acute distress. She is, however, quite upset with the widespread collections of vesicles on mildly erythematous bases, many in a linear configuration. In several areas, there is ecchymosis secondary to scratching.
What’s the diagnosis?
DISCUSSION
Poison ivy, or Rhus dermatitis, is one of the most common dermatologic problems seen in medicine—and yet, its various presentations can, as this case illustrates, be quite confusing. Even when it is recognized, treatment is far from satisfactory (but more on that later). Furthermore, there is a lot of misinformation about everything from the appearance of the offending plant to the condition’s “contagious” nature.
From a broader perspective, poison ivy is becoming more prevalent and its effects more pronounced as cities expand into formerly open country. The Rhus plant family (Toxicodendron radicans and others) thrives on our increasing levels of CO2, effectively making the “poisonous” resin in the stems, leaves, and berries more potent.
With repeated exposure, the vast majority of the population will develop an allergy to this resin, known as urushiol, which can persist even on long-dead plants, vines, and leaves. (It does take repeated exposure to develop the requisite T-cell population, which is why many children are immune to it.) The urushiol does not serve as a protective substance for the plant; rather, it helps the plant retain water. In fact, many animals feed on the plant with impunity.
Virtually all members of the poison ivy family display “leaves of three” emerging from a single stem, with each triplet alternating first on one side of the branch and then on the other. Several varieties of the plant flourish over vast areas of the world, but in the United States, east of the Rockies, Toxicodendron radicans is the dominant member of the family. It can grow as a low vine, a shrub, or a climbing vine, each with a distinct appearance aside from the leaves, which are almond-shaped, smooth, and usually shiny with smooth surfaces. Most mature leaves will have a single notch, sometimes called a “thumb,” on otherwise smooth, nonserrated edges. In the summer, tiny white and yellow berries begin to grow.
The climbing vines of older plants can reach heights of 10 meters or more. These vines can reach a thickness of 3 inches and often appear “furry,” with tiny rootlets covering their surfaces. Plants this large can produce leaves 12 to 14 inches long.
Clinically, the appearance of linear pink to red pruritic vesicular streaks typify this contact dermatitis, which can immediately follow exposure or take days to appear. Said exposure can be direct or via pets, tools, or aerosols (eg, from neighbors mowing their lawns). Besides avoidance of the great outdoors, washing thoroughly immediately after exposure makes sense (but many are unaware that they’ve been exposed until it’s too late).
Poison ivy is not contagious, though the general public firmly believes otherwise. Left untreated, it clears within 2 weeks (except in unusual cases). For those who cannot bear to wait, treatment is problematic, to say the least. OTC products, such as calamine lotion, do nothing for the itching but may help with blistering. Topical or systemic steroids reduce itching somewhat. Antihistamines are useless, since this condition does not involve histamine release.
TAKE-HOME LEARNING POINTS
- Poison ivy (Rhus dermatitis) is quite common and becoming more so due to encroaching civilization and increasing CO2 levels.
- “Leaves of three, let it be” is still good advice, because the poison ivy plant Toxicodendron radicans manifests with three almond-shaped, shiny, green leaves grouped in threes.
- Urushiol is the name of the oily resin found in the plant’s stem, leaves, and berries, and is the trigger resulting in contact dermatitis.
- Poison ivy is not contagious and typically clears in 2 weeks.
Left ear pain
The FP suspected cutaneous vasculitis of the ear caused by levamisole-adulterated cocaine.
Levamisole is an antihelminthic drug approved for veterinary purposes. In the past, the drug had been used as an immune modulator in autoimmune disorders, but no longer is considered safe for human use, as it can cause agranulocytosis. Sellers around the world often lace cocaine with levamisole because it boosts the profits and potentiates the psychoactive effects of the cocaine. Cutaneous vasculitis secondary to levamisole-adulterated cocaine has been reported many times in the literature.
Levamisole-associated vasculitis presents with ear purpura, retiform (like a net) purpura of the trunk or extremities, and neutropenia. Patients will test positive for perinuclear antineutrophil cytoplasmic antibody (pANCA). This cutaneous vasculitis also may present on the nose or face. There are reports of cocaine/levamisole-associated autoimmune syndrome involving agranulocytosis and cutaneous vasculitis.
The patient tested positive for pANCA, as was expected. The FP told her to discontinue her cocaine use, as she ran the risk of worse manifestations. She refused any treatment for her drug use and stated she could stop it on her own. The FP referred the patient to Dermatology, but the vasculitis was barely visible by the time she was seen. Convincing the patient not to use cocaine again remained the only treatment.
Photo courtesy of Jon Karnes, MD, and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux EJ, Usatine R, Martin N, et al. Vasculitis. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1169-1173.
To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/
You can get the 3rd edition of the Color Atlas and Synopsis of Family Medicine as an app by clicking on this link: https://usatinemedia.com/app/color-atlas-of-family-medicine/
The FP suspected cutaneous vasculitis of the ear caused by levamisole-adulterated cocaine.
Levamisole is an antihelminthic drug approved for veterinary purposes. In the past, the drug had been used as an immune modulator in autoimmune disorders, but no longer is considered safe for human use, as it can cause agranulocytosis. Sellers around the world often lace cocaine with levamisole because it boosts the profits and potentiates the psychoactive effects of the cocaine. Cutaneous vasculitis secondary to levamisole-adulterated cocaine has been reported many times in the literature.
Levamisole-associated vasculitis presents with ear purpura, retiform (like a net) purpura of the trunk or extremities, and neutropenia. Patients will test positive for perinuclear antineutrophil cytoplasmic antibody (pANCA). This cutaneous vasculitis also may present on the nose or face. There are reports of cocaine/levamisole-associated autoimmune syndrome involving agranulocytosis and cutaneous vasculitis.
The patient tested positive for pANCA, as was expected. The FP told her to discontinue her cocaine use, as she ran the risk of worse manifestations. She refused any treatment for her drug use and stated she could stop it on her own. The FP referred the patient to Dermatology, but the vasculitis was barely visible by the time she was seen. Convincing the patient not to use cocaine again remained the only treatment.
Photo courtesy of Jon Karnes, MD, and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux EJ, Usatine R, Martin N, et al. Vasculitis. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1169-1173.
To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/
You can get the 3rd edition of the Color Atlas and Synopsis of Family Medicine as an app by clicking on this link: https://usatinemedia.com/app/color-atlas-of-family-medicine/
The FP suspected cutaneous vasculitis of the ear caused by levamisole-adulterated cocaine.
Levamisole is an antihelminthic drug approved for veterinary purposes. In the past, the drug had been used as an immune modulator in autoimmune disorders, but no longer is considered safe for human use, as it can cause agranulocytosis. Sellers around the world often lace cocaine with levamisole because it boosts the profits and potentiates the psychoactive effects of the cocaine. Cutaneous vasculitis secondary to levamisole-adulterated cocaine has been reported many times in the literature.
Levamisole-associated vasculitis presents with ear purpura, retiform (like a net) purpura of the trunk or extremities, and neutropenia. Patients will test positive for perinuclear antineutrophil cytoplasmic antibody (pANCA). This cutaneous vasculitis also may present on the nose or face. There are reports of cocaine/levamisole-associated autoimmune syndrome involving agranulocytosis and cutaneous vasculitis.
The patient tested positive for pANCA, as was expected. The FP told her to discontinue her cocaine use, as she ran the risk of worse manifestations. She refused any treatment for her drug use and stated she could stop it on her own. The FP referred the patient to Dermatology, but the vasculitis was barely visible by the time she was seen. Convincing the patient not to use cocaine again remained the only treatment.
Photo courtesy of Jon Karnes, MD, and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux EJ, Usatine R, Martin N, et al. Vasculitis. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1169-1173.
To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/
You can get the 3rd edition of the Color Atlas and Synopsis of Family Medicine as an app by clicking on this link: https://usatinemedia.com/app/color-atlas-of-family-medicine/
Trump administration finalizing ban on flavored e-cigarettes
The Food and Drug Administration is finalizing a compliance policy that will target flavored e-cigarettes and aim to clear the market of unauthorized, non–tobacco-flavored e-cigarette products, U.S. Department of Health & Human Services Secretary Alex M. Azar II announced Sept. 11.
“The Trump administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools, and communities,” Mr. Azar said in a statement. “We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”
The announcement comes as the Centers for Disease Control and Prevention and state health departments track hundreds of lung-related illnesses that are linked to the use of e-cigarettes. At least 450 cases have been reported in 33 states and one jurisdiction. Diagnoses include lipoid pneumonia, alveolar hemorrhage, and cryptogenic organizing pneumonia, according to a Sept. 6 press briefing by Ileana Arias, PhD, CDC acting deputy director for non-infectious diseases. Six deaths associated with the illnesses have been reported thus far.
Details of new regulatory action will be forthcoming and will outline enforcement policy for non–tobacco-flavored e-cigarette products that lack premarket authorization, HHS officials said. According to federal rules, all electronic nicotine delivery system (ENDS) products must file premarket tobacco product applications with the FDA within 2 years. Many ENDS products currently on the market are not being legally marketed and are subject to government action, according to the Trump administration.
“Once finalized, this compliance policy will serve as a powerful tool that the FDA can use to combat the troubling trend of youth e-cigarette use,” Ned Sharpless, MD, acting FDA commissioner, said in the statement. “We must act swiftly against flavored e-cigarette products that are especially attractive to children. Moreover, if we see a migration to tobacco-flavored products by kids, we will take additional steps to address youth use of these products.”
Federal officials noted that preliminary numbers from the National Youth Tobacco Survey show a continued rise in youth e-cigarette use, with more than a quarter of high school students current e-cigarette users in 2019. The overwhelming majority of youth e-cigarette users cited the use of fruit, menthol, or mint flavors, according to the preliminary data, which have not yet been published.
According to 2018 survey data, e-cigarette use increased from 12% to 21% among high school students and from 3% to 5% among middle school students from 2017 to 2018. There were 1.5 million more youth e-cigarette users in 2018 than in 2017, and youth who were using e-cigarettes were using them more often, according to the survey.
The Food and Drug Administration is finalizing a compliance policy that will target flavored e-cigarettes and aim to clear the market of unauthorized, non–tobacco-flavored e-cigarette products, U.S. Department of Health & Human Services Secretary Alex M. Azar II announced Sept. 11.
“The Trump administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools, and communities,” Mr. Azar said in a statement. “We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”
The announcement comes as the Centers for Disease Control and Prevention and state health departments track hundreds of lung-related illnesses that are linked to the use of e-cigarettes. At least 450 cases have been reported in 33 states and one jurisdiction. Diagnoses include lipoid pneumonia, alveolar hemorrhage, and cryptogenic organizing pneumonia, according to a Sept. 6 press briefing by Ileana Arias, PhD, CDC acting deputy director for non-infectious diseases. Six deaths associated with the illnesses have been reported thus far.
Details of new regulatory action will be forthcoming and will outline enforcement policy for non–tobacco-flavored e-cigarette products that lack premarket authorization, HHS officials said. According to federal rules, all electronic nicotine delivery system (ENDS) products must file premarket tobacco product applications with the FDA within 2 years. Many ENDS products currently on the market are not being legally marketed and are subject to government action, according to the Trump administration.
“Once finalized, this compliance policy will serve as a powerful tool that the FDA can use to combat the troubling trend of youth e-cigarette use,” Ned Sharpless, MD, acting FDA commissioner, said in the statement. “We must act swiftly against flavored e-cigarette products that are especially attractive to children. Moreover, if we see a migration to tobacco-flavored products by kids, we will take additional steps to address youth use of these products.”
Federal officials noted that preliminary numbers from the National Youth Tobacco Survey show a continued rise in youth e-cigarette use, with more than a quarter of high school students current e-cigarette users in 2019. The overwhelming majority of youth e-cigarette users cited the use of fruit, menthol, or mint flavors, according to the preliminary data, which have not yet been published.
According to 2018 survey data, e-cigarette use increased from 12% to 21% among high school students and from 3% to 5% among middle school students from 2017 to 2018. There were 1.5 million more youth e-cigarette users in 2018 than in 2017, and youth who were using e-cigarettes were using them more often, according to the survey.
The Food and Drug Administration is finalizing a compliance policy that will target flavored e-cigarettes and aim to clear the market of unauthorized, non–tobacco-flavored e-cigarette products, U.S. Department of Health & Human Services Secretary Alex M. Azar II announced Sept. 11.
“The Trump administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools, and communities,” Mr. Azar said in a statement. “We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”
The announcement comes as the Centers for Disease Control and Prevention and state health departments track hundreds of lung-related illnesses that are linked to the use of e-cigarettes. At least 450 cases have been reported in 33 states and one jurisdiction. Diagnoses include lipoid pneumonia, alveolar hemorrhage, and cryptogenic organizing pneumonia, according to a Sept. 6 press briefing by Ileana Arias, PhD, CDC acting deputy director for non-infectious diseases. Six deaths associated with the illnesses have been reported thus far.
Details of new regulatory action will be forthcoming and will outline enforcement policy for non–tobacco-flavored e-cigarette products that lack premarket authorization, HHS officials said. According to federal rules, all electronic nicotine delivery system (ENDS) products must file premarket tobacco product applications with the FDA within 2 years. Many ENDS products currently on the market are not being legally marketed and are subject to government action, according to the Trump administration.
“Once finalized, this compliance policy will serve as a powerful tool that the FDA can use to combat the troubling trend of youth e-cigarette use,” Ned Sharpless, MD, acting FDA commissioner, said in the statement. “We must act swiftly against flavored e-cigarette products that are especially attractive to children. Moreover, if we see a migration to tobacco-flavored products by kids, we will take additional steps to address youth use of these products.”
Federal officials noted that preliminary numbers from the National Youth Tobacco Survey show a continued rise in youth e-cigarette use, with more than a quarter of high school students current e-cigarette users in 2019. The overwhelming majority of youth e-cigarette users cited the use of fruit, menthol, or mint flavors, according to the preliminary data, which have not yet been published.
According to 2018 survey data, e-cigarette use increased from 12% to 21% among high school students and from 3% to 5% among middle school students from 2017 to 2018. There were 1.5 million more youth e-cigarette users in 2018 than in 2017, and youth who were using e-cigarettes were using them more often, according to the survey.
Insurers to pay record number of rebates to patients
Health insurance companies are getting ready to disburse a record $1.3 billion in medical loss ratio (MLR) rebates, according to an analysis by the Kaiser Family Foundation.
The $1.3 billion surpasses the previous rebate record of $1.1 billion, issued in 2012.
The increase is driven largely by individual market insurers who will pay $743 million in rebates this year, according to the report, which analyzed insurer data submitted to the Centers for Medicare & Medicaid Services. Rebates in the small-group and large-group insurance markets are similar to previous years, with expected paybacks of $250 million from small- and $284 million from large-group markets, according to the Kaiser report. Insurance companies have until September 30, 2019, to start issuing rebates.
The rebates stem from the MLR requirement imposed by the Affordable Care Act (ACA), which limits the amount of premium dollars that can be used for administration, marketing, and profit. Under the health law, companies are required to publicly report how much they spend on health care, quality improvement, and other activities using premium funds. Individual and small-group market insurers must spend at least 80% on health care claims and quality improvement,while large-group plans must spend at least 85%. Rebates are based on a 3-year average of financial data by each insurer.
Patients in the individual insurance market can expect their rebate in either a premium credit or a check. In the large and small group markets, rebates may be split between employee and employer depending on the plan contract.
The volume of rebates differed greatly across the states, with some states paying zero rebates and others paying millions. Virginia insurers for example, will pay the highest number of total rebates ($150 million), followed by Pennsylvania ($130 million) and Florida ($107 million), according to the report. Payments by insurers in the individual market alone ranged from zero dollars in 13 states to $111 million in Virginia. Individual market insurers in Arizona will pay $92 million in rebates to patients, while individual plans in Texas will pay $80 million. Florida insurers will pay the highest in rebates in both the small-group and large-group market at $44 million and $42 million respectively.
The largest rebates within the individual market will come from Centene, HCSC, Cigna, and Highmark. Authors of the report noted that these insurers tend to have higher enrollment and are active in multiple states.
Individual marketplace insurers will likely pay high rebates against next year, based on an individual market that remains strong and profitable, despite the recent elimination of the individual mandate penalty, according to the authors.
Health insurance companies are getting ready to disburse a record $1.3 billion in medical loss ratio (MLR) rebates, according to an analysis by the Kaiser Family Foundation.
The $1.3 billion surpasses the previous rebate record of $1.1 billion, issued in 2012.
The increase is driven largely by individual market insurers who will pay $743 million in rebates this year, according to the report, which analyzed insurer data submitted to the Centers for Medicare & Medicaid Services. Rebates in the small-group and large-group insurance markets are similar to previous years, with expected paybacks of $250 million from small- and $284 million from large-group markets, according to the Kaiser report. Insurance companies have until September 30, 2019, to start issuing rebates.
The rebates stem from the MLR requirement imposed by the Affordable Care Act (ACA), which limits the amount of premium dollars that can be used for administration, marketing, and profit. Under the health law, companies are required to publicly report how much they spend on health care, quality improvement, and other activities using premium funds. Individual and small-group market insurers must spend at least 80% on health care claims and quality improvement,while large-group plans must spend at least 85%. Rebates are based on a 3-year average of financial data by each insurer.
Patients in the individual insurance market can expect their rebate in either a premium credit or a check. In the large and small group markets, rebates may be split between employee and employer depending on the plan contract.
The volume of rebates differed greatly across the states, with some states paying zero rebates and others paying millions. Virginia insurers for example, will pay the highest number of total rebates ($150 million), followed by Pennsylvania ($130 million) and Florida ($107 million), according to the report. Payments by insurers in the individual market alone ranged from zero dollars in 13 states to $111 million in Virginia. Individual market insurers in Arizona will pay $92 million in rebates to patients, while individual plans in Texas will pay $80 million. Florida insurers will pay the highest in rebates in both the small-group and large-group market at $44 million and $42 million respectively.
The largest rebates within the individual market will come from Centene, HCSC, Cigna, and Highmark. Authors of the report noted that these insurers tend to have higher enrollment and are active in multiple states.
Individual marketplace insurers will likely pay high rebates against next year, based on an individual market that remains strong and profitable, despite the recent elimination of the individual mandate penalty, according to the authors.
Health insurance companies are getting ready to disburse a record $1.3 billion in medical loss ratio (MLR) rebates, according to an analysis by the Kaiser Family Foundation.
The $1.3 billion surpasses the previous rebate record of $1.1 billion, issued in 2012.
The increase is driven largely by individual market insurers who will pay $743 million in rebates this year, according to the report, which analyzed insurer data submitted to the Centers for Medicare & Medicaid Services. Rebates in the small-group and large-group insurance markets are similar to previous years, with expected paybacks of $250 million from small- and $284 million from large-group markets, according to the Kaiser report. Insurance companies have until September 30, 2019, to start issuing rebates.
The rebates stem from the MLR requirement imposed by the Affordable Care Act (ACA), which limits the amount of premium dollars that can be used for administration, marketing, and profit. Under the health law, companies are required to publicly report how much they spend on health care, quality improvement, and other activities using premium funds. Individual and small-group market insurers must spend at least 80% on health care claims and quality improvement,while large-group plans must spend at least 85%. Rebates are based on a 3-year average of financial data by each insurer.
Patients in the individual insurance market can expect their rebate in either a premium credit or a check. In the large and small group markets, rebates may be split between employee and employer depending on the plan contract.
The volume of rebates differed greatly across the states, with some states paying zero rebates and others paying millions. Virginia insurers for example, will pay the highest number of total rebates ($150 million), followed by Pennsylvania ($130 million) and Florida ($107 million), according to the report. Payments by insurers in the individual market alone ranged from zero dollars in 13 states to $111 million in Virginia. Individual market insurers in Arizona will pay $92 million in rebates to patients, while individual plans in Texas will pay $80 million. Florida insurers will pay the highest in rebates in both the small-group and large-group market at $44 million and $42 million respectively.
The largest rebates within the individual market will come from Centene, HCSC, Cigna, and Highmark. Authors of the report noted that these insurers tend to have higher enrollment and are active in multiple states.
Individual marketplace insurers will likely pay high rebates against next year, based on an individual market that remains strong and profitable, despite the recent elimination of the individual mandate penalty, according to the authors.
Stem cells gene edited to be HIV resistant treat ALL, but not HIV
Gene editing of donor stem cells prior to transplantation into a patient with both HIV infection and acute lymphoblastic leukemia (ALL) was safe and effectively treated the patient’s leukemia, but failed to resolve his HIV, investigators reported.
The 27-year-old man received an HLA-matched transplant of hematopoietic stem and progenitor cells (HSPCs) that had been genetically engineered to lack CCR5, a key gateway for HIV entry into cells.
Although the transplant resulted in complete remission of leukemia with full donor chimerism, only about 9% of the posttransplant lymphocytes showed disruption of CCR5, and during a brief trial of antiretroviral therapy interruption his HIV viral load rebounded, reported Hongkui Deng, PhD, and colleagues from Peking University in China.
Although the experiment did not meet its goal of a drug-free HIV remission, it serves as a proof of concept for the use of CRISPR-Cas9 (clustered regularly interspaced palindromic repeats/CRISPR-associated protein 9) gene editing to treat HIV infection, the authors contend.
“These results show the proof of principle that transplantation and long-term engraftment of CRISPR-edited allogeneic HSPCs can be achieved; however, the efficiency of the response was not adequate to achieve the target of cure of HIV-1 infection,” they wrote in a brief report published in the New England Journal of Medicine.
As previously reported, other research groups have investigated genetic editing to mimic a naturally occurring mutation that effectively disables the CCR5 HIV coreceptor, preventing the retrovirus from entering healthy cells. The mutation was first identified in a man named Timothy Brown who came to be known as “the Berlin patient” after he was apparently cured of HIV infection after a bone marrow transplant from a donor who had the mutation.
Dr. Deng and colleagues took advantage of HSPC transplantation, a standard therapy for ALL to see whether it could also have beneficial effects on concomitant HIV infection.
They treated donor HSPCs with CRISPR-Cas9 to ablate CCR5 and then delivered them to the patient along with additional CD34-depleted donor cells from mobilized peripheral blood.
The transplant was a success, with neutrophil engraftment on day 13 and platelet engraftment on day 27, and the leukemia was in morphologic complete remission at week 4 following transplantation. The patient remained in complete remission from leukemia throughout the 19-month follow-up period, with full donor chimerism .
However, when a planned interruption of antiretroviral therapy was carried out at 7 months post transplant, the serum viral load increased to 3 × 107 copies/ml at week 4 following interruption, and the patient was restarted on the drug. His viral levels gradually decreased to undetectable level during the subsequent months.
The investigators noted that 2 weeks after the drug interruption trial was started there was a small increase in the percentage of CCR5 insertion/deletions.
“The low efficiency of gene editing in the patient may be due to the competitive engraftment of the coinfused HSPCs in CD34-depleted cells and the persistence of donor T cells. To further clarify the anti-HIV effect of CCR5-ablated HSPCs, it will be essential to increase the gene-editing efficiency of our CRISPR-Cas9 system and improve the transplantation protocol,” they wrote.
The study was funded by the Beijing Municipal Science and Technology Commission and others (unspecified). All authors reported having nothing to disclose.
SOURCE: Xu L et al. N Engl J Med. 2019. doi: 10.1056/NEJMoa1817426.
Gene editing of donor stem cells prior to transplantation into a patient with both HIV infection and acute lymphoblastic leukemia (ALL) was safe and effectively treated the patient’s leukemia, but failed to resolve his HIV, investigators reported.
The 27-year-old man received an HLA-matched transplant of hematopoietic stem and progenitor cells (HSPCs) that had been genetically engineered to lack CCR5, a key gateway for HIV entry into cells.
Although the transplant resulted in complete remission of leukemia with full donor chimerism, only about 9% of the posttransplant lymphocytes showed disruption of CCR5, and during a brief trial of antiretroviral therapy interruption his HIV viral load rebounded, reported Hongkui Deng, PhD, and colleagues from Peking University in China.
Although the experiment did not meet its goal of a drug-free HIV remission, it serves as a proof of concept for the use of CRISPR-Cas9 (clustered regularly interspaced palindromic repeats/CRISPR-associated protein 9) gene editing to treat HIV infection, the authors contend.
“These results show the proof of principle that transplantation and long-term engraftment of CRISPR-edited allogeneic HSPCs can be achieved; however, the efficiency of the response was not adequate to achieve the target of cure of HIV-1 infection,” they wrote in a brief report published in the New England Journal of Medicine.
As previously reported, other research groups have investigated genetic editing to mimic a naturally occurring mutation that effectively disables the CCR5 HIV coreceptor, preventing the retrovirus from entering healthy cells. The mutation was first identified in a man named Timothy Brown who came to be known as “the Berlin patient” after he was apparently cured of HIV infection after a bone marrow transplant from a donor who had the mutation.
Dr. Deng and colleagues took advantage of HSPC transplantation, a standard therapy for ALL to see whether it could also have beneficial effects on concomitant HIV infection.
They treated donor HSPCs with CRISPR-Cas9 to ablate CCR5 and then delivered them to the patient along with additional CD34-depleted donor cells from mobilized peripheral blood.
The transplant was a success, with neutrophil engraftment on day 13 and platelet engraftment on day 27, and the leukemia was in morphologic complete remission at week 4 following transplantation. The patient remained in complete remission from leukemia throughout the 19-month follow-up period, with full donor chimerism .
However, when a planned interruption of antiretroviral therapy was carried out at 7 months post transplant, the serum viral load increased to 3 × 107 copies/ml at week 4 following interruption, and the patient was restarted on the drug. His viral levels gradually decreased to undetectable level during the subsequent months.
The investigators noted that 2 weeks after the drug interruption trial was started there was a small increase in the percentage of CCR5 insertion/deletions.
“The low efficiency of gene editing in the patient may be due to the competitive engraftment of the coinfused HSPCs in CD34-depleted cells and the persistence of donor T cells. To further clarify the anti-HIV effect of CCR5-ablated HSPCs, it will be essential to increase the gene-editing efficiency of our CRISPR-Cas9 system and improve the transplantation protocol,” they wrote.
The study was funded by the Beijing Municipal Science and Technology Commission and others (unspecified). All authors reported having nothing to disclose.
SOURCE: Xu L et al. N Engl J Med. 2019. doi: 10.1056/NEJMoa1817426.
Gene editing of donor stem cells prior to transplantation into a patient with both HIV infection and acute lymphoblastic leukemia (ALL) was safe and effectively treated the patient’s leukemia, but failed to resolve his HIV, investigators reported.
The 27-year-old man received an HLA-matched transplant of hematopoietic stem and progenitor cells (HSPCs) that had been genetically engineered to lack CCR5, a key gateway for HIV entry into cells.
Although the transplant resulted in complete remission of leukemia with full donor chimerism, only about 9% of the posttransplant lymphocytes showed disruption of CCR5, and during a brief trial of antiretroviral therapy interruption his HIV viral load rebounded, reported Hongkui Deng, PhD, and colleagues from Peking University in China.
Although the experiment did not meet its goal of a drug-free HIV remission, it serves as a proof of concept for the use of CRISPR-Cas9 (clustered regularly interspaced palindromic repeats/CRISPR-associated protein 9) gene editing to treat HIV infection, the authors contend.
“These results show the proof of principle that transplantation and long-term engraftment of CRISPR-edited allogeneic HSPCs can be achieved; however, the efficiency of the response was not adequate to achieve the target of cure of HIV-1 infection,” they wrote in a brief report published in the New England Journal of Medicine.
As previously reported, other research groups have investigated genetic editing to mimic a naturally occurring mutation that effectively disables the CCR5 HIV coreceptor, preventing the retrovirus from entering healthy cells. The mutation was first identified in a man named Timothy Brown who came to be known as “the Berlin patient” after he was apparently cured of HIV infection after a bone marrow transplant from a donor who had the mutation.
Dr. Deng and colleagues took advantage of HSPC transplantation, a standard therapy for ALL to see whether it could also have beneficial effects on concomitant HIV infection.
They treated donor HSPCs with CRISPR-Cas9 to ablate CCR5 and then delivered them to the patient along with additional CD34-depleted donor cells from mobilized peripheral blood.
The transplant was a success, with neutrophil engraftment on day 13 and platelet engraftment on day 27, and the leukemia was in morphologic complete remission at week 4 following transplantation. The patient remained in complete remission from leukemia throughout the 19-month follow-up period, with full donor chimerism .
However, when a planned interruption of antiretroviral therapy was carried out at 7 months post transplant, the serum viral load increased to 3 × 107 copies/ml at week 4 following interruption, and the patient was restarted on the drug. His viral levels gradually decreased to undetectable level during the subsequent months.
The investigators noted that 2 weeks after the drug interruption trial was started there was a small increase in the percentage of CCR5 insertion/deletions.
“The low efficiency of gene editing in the patient may be due to the competitive engraftment of the coinfused HSPCs in CD34-depleted cells and the persistence of donor T cells. To further clarify the anti-HIV effect of CCR5-ablated HSPCs, it will be essential to increase the gene-editing efficiency of our CRISPR-Cas9 system and improve the transplantation protocol,” they wrote.
The study was funded by the Beijing Municipal Science and Technology Commission and others (unspecified). All authors reported having nothing to disclose.
SOURCE: Xu L et al. N Engl J Med. 2019. doi: 10.1056/NEJMoa1817426.
FROM NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Donor cells depleted of the HIV coreceptor CCR5 effectively treated ALL, but not HIV.
Major finding: The patient had a sustained complete remission of ALL, but HIV persisted after transplantation.
Study details: Case report of a 27-year-old man with ALL and HIV.
Disclosures: The study was funded by the Beijing Municipal Science and Technology Commission and others (unspecified). All authors reported having nothing to disclose.
Source: Xu L et al. N Engl J Med. 2019. doi: 10.1056/NEJMoa1817426.
No decrease in preterm birth with n-3 fatty acid supplements
according to data published in the New England Journal of Medicine.
Maria Makrides, PhD, of the South Australian Health and Medical Research Institute, North Adelaide, and coauthors wrote there is evidence that n-3 long-chain polyunsaturated fatty acids play an essential role in labor initiation.
“Typical Western diets are relatively low in n-3 long-chain polyunsaturated fatty acids, which leads to a predominance of 2-series prostaglandin substrate in the fetoplacental unit and potentially confers a predisposition to preterm delivery,” they wrote, adding that epidemiologic studies have suggested associations between lower fish consumption in pregnancy and a higher rate of preterm delivery.
In a multicenter, double-blind trial, 5,517 women were randomized to either a daily fish oil supplement containing 900 mg of n-3 long-chain polyunsaturated fatty acids or vegetable oil capsules, from before 20 weeks’ gestation until 34 weeks’ gestation or delivery.
Among the 5,486 pregnancies included in the final analysis, there were no differences between the intervention and control groups in the primary outcome of early preterm delivery, which occurred in 2.2% of pregnancies in the n-3 fatty acid group and 2% of the control group (P = 0.5).
The study also saw no significant differences between the two groups in other outcomes such as the rates of preterm delivery, preterm spontaneous labor, postterm induction, or gestational age at delivery. Similarly, there were no apparent effects of supplementation on maternal and neonatal outcomes including low birth weight, admission to neonatal intensive care, gestational diabetes, postpartum hemorrhage, or preeclampsia.
The analysis did suggest a greater incidence of infants born very large for gestational age – with a birth weight above the 97th percentile – among women in the fatty acid supplement group, but this did not correspond to an increased rate of interventions such as cesarean section or postterm induction.
The authors commented that their finding of more very-large-for-gestational-age babies added to the debate about whether n-3 long-chain polyunsaturated fatty acid supplementation did have a direct impact on fetal growth, although they also noted that it could be a chance finding.
There were also no significant differences between the two groups in serious adverse events, including miscarriage.
The authors noted that the baseline level of n-3 long-chain polyunsaturated fatty acids in the women enrolled in trial may have been higher than in previous studies.
The study was supported by the Australian National Health and Medical Research Council and the Thyne Reid Foundation, with in-kind support from Croda UK and Efamol/Wassen UK. Two authors declared advisory board fees from private industry, and one also declared a patent relating to fatty acids in research. No other conflicts of interest were declared.
SOURCE: Makrides M et al. N Engl J Med. 2019;381:1035-45.
according to data published in the New England Journal of Medicine.
Maria Makrides, PhD, of the South Australian Health and Medical Research Institute, North Adelaide, and coauthors wrote there is evidence that n-3 long-chain polyunsaturated fatty acids play an essential role in labor initiation.
“Typical Western diets are relatively low in n-3 long-chain polyunsaturated fatty acids, which leads to a predominance of 2-series prostaglandin substrate in the fetoplacental unit and potentially confers a predisposition to preterm delivery,” they wrote, adding that epidemiologic studies have suggested associations between lower fish consumption in pregnancy and a higher rate of preterm delivery.
In a multicenter, double-blind trial, 5,517 women were randomized to either a daily fish oil supplement containing 900 mg of n-3 long-chain polyunsaturated fatty acids or vegetable oil capsules, from before 20 weeks’ gestation until 34 weeks’ gestation or delivery.
Among the 5,486 pregnancies included in the final analysis, there were no differences between the intervention and control groups in the primary outcome of early preterm delivery, which occurred in 2.2% of pregnancies in the n-3 fatty acid group and 2% of the control group (P = 0.5).
The study also saw no significant differences between the two groups in other outcomes such as the rates of preterm delivery, preterm spontaneous labor, postterm induction, or gestational age at delivery. Similarly, there were no apparent effects of supplementation on maternal and neonatal outcomes including low birth weight, admission to neonatal intensive care, gestational diabetes, postpartum hemorrhage, or preeclampsia.
The analysis did suggest a greater incidence of infants born very large for gestational age – with a birth weight above the 97th percentile – among women in the fatty acid supplement group, but this did not correspond to an increased rate of interventions such as cesarean section or postterm induction.
The authors commented that their finding of more very-large-for-gestational-age babies added to the debate about whether n-3 long-chain polyunsaturated fatty acid supplementation did have a direct impact on fetal growth, although they also noted that it could be a chance finding.
There were also no significant differences between the two groups in serious adverse events, including miscarriage.
The authors noted that the baseline level of n-3 long-chain polyunsaturated fatty acids in the women enrolled in trial may have been higher than in previous studies.
The study was supported by the Australian National Health and Medical Research Council and the Thyne Reid Foundation, with in-kind support from Croda UK and Efamol/Wassen UK. Two authors declared advisory board fees from private industry, and one also declared a patent relating to fatty acids in research. No other conflicts of interest were declared.
SOURCE: Makrides M et al. N Engl J Med. 2019;381:1035-45.
according to data published in the New England Journal of Medicine.
Maria Makrides, PhD, of the South Australian Health and Medical Research Institute, North Adelaide, and coauthors wrote there is evidence that n-3 long-chain polyunsaturated fatty acids play an essential role in labor initiation.
“Typical Western diets are relatively low in n-3 long-chain polyunsaturated fatty acids, which leads to a predominance of 2-series prostaglandin substrate in the fetoplacental unit and potentially confers a predisposition to preterm delivery,” they wrote, adding that epidemiologic studies have suggested associations between lower fish consumption in pregnancy and a higher rate of preterm delivery.
In a multicenter, double-blind trial, 5,517 women were randomized to either a daily fish oil supplement containing 900 mg of n-3 long-chain polyunsaturated fatty acids or vegetable oil capsules, from before 20 weeks’ gestation until 34 weeks’ gestation or delivery.
Among the 5,486 pregnancies included in the final analysis, there were no differences between the intervention and control groups in the primary outcome of early preterm delivery, which occurred in 2.2% of pregnancies in the n-3 fatty acid group and 2% of the control group (P = 0.5).
The study also saw no significant differences between the two groups in other outcomes such as the rates of preterm delivery, preterm spontaneous labor, postterm induction, or gestational age at delivery. Similarly, there were no apparent effects of supplementation on maternal and neonatal outcomes including low birth weight, admission to neonatal intensive care, gestational diabetes, postpartum hemorrhage, or preeclampsia.
The analysis did suggest a greater incidence of infants born very large for gestational age – with a birth weight above the 97th percentile – among women in the fatty acid supplement group, but this did not correspond to an increased rate of interventions such as cesarean section or postterm induction.
The authors commented that their finding of more very-large-for-gestational-age babies added to the debate about whether n-3 long-chain polyunsaturated fatty acid supplementation did have a direct impact on fetal growth, although they also noted that it could be a chance finding.
There were also no significant differences between the two groups in serious adverse events, including miscarriage.
The authors noted that the baseline level of n-3 long-chain polyunsaturated fatty acids in the women enrolled in trial may have been higher than in previous studies.
The study was supported by the Australian National Health and Medical Research Council and the Thyne Reid Foundation, with in-kind support from Croda UK and Efamol/Wassen UK. Two authors declared advisory board fees from private industry, and one also declared a patent relating to fatty acids in research. No other conflicts of interest were declared.
SOURCE: Makrides M et al. N Engl J Med. 2019;381:1035-45.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: No decrease in preterm birth was seen with n-3 fatty acid supplementation during pregnancy, compared with controls.
Major finding: Early preterm delivery occurred in 2.2% of pregnancies in the n-3 fatty acid group and 2% of the control group (P = 0.5).
Study details: A multicenter, double-blind trial in 5,517 women.
Disclosures: The study was supported by the Australian National Health and Medical Research Council and the Thyne Reid Foundation, with in-kind support from Croda UK and Efamol/Wassen UK. Two authors declared advisory board fees from private industry, and one also declared a patent relating to fatty acids in research. No other conflicts of interest were declared.
Source: Makrides M et al. N Engl J Med. 2019;381:1035-45.
iPhone trypophobia and chicken kissin’
Please, no photos
What does the new iPhone have in common with honeycombs and lotus flowers? They all strike terror and nausea in the hearts of trypophobics everywhere.
Trypophobia, in case you haven’t heard, is the fear of irregular patterns of holes or bumps clustered together. It sounds weird, until you look at photos like this and your skin starts to crawl. Now, we can add the iPhone 11 to the list of fear-inducing everyday objects. The new phone design includes three camera lenses, and it’s giving people … issues. Sure, amateur photographers are ecstatic, but social media users collectively shuddered over their keyboards when the tri-camera was revealed.
Trypophobia is not widely studied, but it’s been theorized that the revulsion is a biological instinct against things that look unsafe or diseased. Safe to say this might lead to Apple losing that core demographic – the trypophobe population. They’ll be switching to Androids en masse.
Don’t kiss your chickens after they hatch
All in all, it’s pretty easy to avoid getting salmonella. Refrigerate your food properly. Don’t eat undercooked ground meats. Oh, and don’t kiss the chickens you’ve been raising in your backyard.
Okay, that’s not the only takeaway from a Centers for Disease Control and Prevention update on the 2019 salmonella outbreak that has so far affected just over a thousand people in 49 states. Because the outbreak has been linked to the increased prevalence of backyard poultry, with 67% of patients interviewed reporting contact with chicks and/or ducklings, the CDC has issued a slew of recommendations on how to avoid salmonella.
Some of them are common sense: Don’t let small children handle livestock, and wash your hands after contact. Some are a bit bizarre: Don’t let poultry wander through your house, and don’t eat or drink where livestock roam and live (eww).
Then there’s the gem: Don’t kiss your chickens, or snuggle them and then touch your face and/or mouth.
We know baby chickens or ducks are adorable. And there’s absolutely nothing wrong with loving your livestock like a cat or dog. Just don’t, um, love your livestock.
Dept. of unintended consequences
This week’s case report is brought to you by the entomologists of Texas Medical Center in Houston.
The original problem: Large numbers of birds, such as grackles and pigeons, which may carry diseases and make a mess with their droppings, were gathering in large numbers in Texas Medical Center’s live oak trees. The campus is visited by 10 million people seeking health care each year.
The solution: Cover the trees with nets to prevent the birds from gathering.
The new problem: The lack of predatory birds has “created a haven for a flourishing population of Megalopyge opercularis, commonly referred to as asps,” according to investigators at Rice University. The asp in question happens to be one of North America’s most toxic caterpillars, and they are 7,300% more abundant in the netted trees, compared with nonnetted trees nearby.
The discussion: “I’ve been stung by a lot of things, and an asp sting definitely ranks high up there,” said Mattheau Comerford, one of the investigators. “It feels like a broken bone, and the pain lasts for hours. I was stung on the wrist, and the pain traveled up my arm, into my arm pit, and my jaw started to feel pain.”
The LOTME recommendation: In this case, the rats with wings … er, we mean pigeons, seem to be the lesser of two evils. Of course, compared with poisonous caterpillars, even kissing a chicken would be the lesser of two evils.
Please, no photos
What does the new iPhone have in common with honeycombs and lotus flowers? They all strike terror and nausea in the hearts of trypophobics everywhere.
Trypophobia, in case you haven’t heard, is the fear of irregular patterns of holes or bumps clustered together. It sounds weird, until you look at photos like this and your skin starts to crawl. Now, we can add the iPhone 11 to the list of fear-inducing everyday objects. The new phone design includes three camera lenses, and it’s giving people … issues. Sure, amateur photographers are ecstatic, but social media users collectively shuddered over their keyboards when the tri-camera was revealed.
Trypophobia is not widely studied, but it’s been theorized that the revulsion is a biological instinct against things that look unsafe or diseased. Safe to say this might lead to Apple losing that core demographic – the trypophobe population. They’ll be switching to Androids en masse.
Don’t kiss your chickens after they hatch
All in all, it’s pretty easy to avoid getting salmonella. Refrigerate your food properly. Don’t eat undercooked ground meats. Oh, and don’t kiss the chickens you’ve been raising in your backyard.
Okay, that’s not the only takeaway from a Centers for Disease Control and Prevention update on the 2019 salmonella outbreak that has so far affected just over a thousand people in 49 states. Because the outbreak has been linked to the increased prevalence of backyard poultry, with 67% of patients interviewed reporting contact with chicks and/or ducklings, the CDC has issued a slew of recommendations on how to avoid salmonella.
Some of them are common sense: Don’t let small children handle livestock, and wash your hands after contact. Some are a bit bizarre: Don’t let poultry wander through your house, and don’t eat or drink where livestock roam and live (eww).
Then there’s the gem: Don’t kiss your chickens, or snuggle them and then touch your face and/or mouth.
We know baby chickens or ducks are adorable. And there’s absolutely nothing wrong with loving your livestock like a cat or dog. Just don’t, um, love your livestock.
Dept. of unintended consequences
This week’s case report is brought to you by the entomologists of Texas Medical Center in Houston.
The original problem: Large numbers of birds, such as grackles and pigeons, which may carry diseases and make a mess with their droppings, were gathering in large numbers in Texas Medical Center’s live oak trees. The campus is visited by 10 million people seeking health care each year.
The solution: Cover the trees with nets to prevent the birds from gathering.
The new problem: The lack of predatory birds has “created a haven for a flourishing population of Megalopyge opercularis, commonly referred to as asps,” according to investigators at Rice University. The asp in question happens to be one of North America’s most toxic caterpillars, and they are 7,300% more abundant in the netted trees, compared with nonnetted trees nearby.
The discussion: “I’ve been stung by a lot of things, and an asp sting definitely ranks high up there,” said Mattheau Comerford, one of the investigators. “It feels like a broken bone, and the pain lasts for hours. I was stung on the wrist, and the pain traveled up my arm, into my arm pit, and my jaw started to feel pain.”
The LOTME recommendation: In this case, the rats with wings … er, we mean pigeons, seem to be the lesser of two evils. Of course, compared with poisonous caterpillars, even kissing a chicken would be the lesser of two evils.
Please, no photos
What does the new iPhone have in common with honeycombs and lotus flowers? They all strike terror and nausea in the hearts of trypophobics everywhere.
Trypophobia, in case you haven’t heard, is the fear of irregular patterns of holes or bumps clustered together. It sounds weird, until you look at photos like this and your skin starts to crawl. Now, we can add the iPhone 11 to the list of fear-inducing everyday objects. The new phone design includes three camera lenses, and it’s giving people … issues. Sure, amateur photographers are ecstatic, but social media users collectively shuddered over their keyboards when the tri-camera was revealed.
Trypophobia is not widely studied, but it’s been theorized that the revulsion is a biological instinct against things that look unsafe or diseased. Safe to say this might lead to Apple losing that core demographic – the trypophobe population. They’ll be switching to Androids en masse.
Don’t kiss your chickens after they hatch
All in all, it’s pretty easy to avoid getting salmonella. Refrigerate your food properly. Don’t eat undercooked ground meats. Oh, and don’t kiss the chickens you’ve been raising in your backyard.
Okay, that’s not the only takeaway from a Centers for Disease Control and Prevention update on the 2019 salmonella outbreak that has so far affected just over a thousand people in 49 states. Because the outbreak has been linked to the increased prevalence of backyard poultry, with 67% of patients interviewed reporting contact with chicks and/or ducklings, the CDC has issued a slew of recommendations on how to avoid salmonella.
Some of them are common sense: Don’t let small children handle livestock, and wash your hands after contact. Some are a bit bizarre: Don’t let poultry wander through your house, and don’t eat or drink where livestock roam and live (eww).
Then there’s the gem: Don’t kiss your chickens, or snuggle them and then touch your face and/or mouth.
We know baby chickens or ducks are adorable. And there’s absolutely nothing wrong with loving your livestock like a cat or dog. Just don’t, um, love your livestock.
Dept. of unintended consequences
This week’s case report is brought to you by the entomologists of Texas Medical Center in Houston.
The original problem: Large numbers of birds, such as grackles and pigeons, which may carry diseases and make a mess with their droppings, were gathering in large numbers in Texas Medical Center’s live oak trees. The campus is visited by 10 million people seeking health care each year.
The solution: Cover the trees with nets to prevent the birds from gathering.
The new problem: The lack of predatory birds has “created a haven for a flourishing population of Megalopyge opercularis, commonly referred to as asps,” according to investigators at Rice University. The asp in question happens to be one of North America’s most toxic caterpillars, and they are 7,300% more abundant in the netted trees, compared with nonnetted trees nearby.
The discussion: “I’ve been stung by a lot of things, and an asp sting definitely ranks high up there,” said Mattheau Comerford, one of the investigators. “It feels like a broken bone, and the pain lasts for hours. I was stung on the wrist, and the pain traveled up my arm, into my arm pit, and my jaw started to feel pain.”
The LOTME recommendation: In this case, the rats with wings … er, we mean pigeons, seem to be the lesser of two evils. Of course, compared with poisonous caterpillars, even kissing a chicken would be the lesser of two evils.