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Tennessee fires top vaccine official as COVID cases increase
Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.
Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.
“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”
In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.
Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.
At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.
Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.
Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.
COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.
In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.
“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”
A version of this article first appeared on WebMD.com.
Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.
Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.
“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”
In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.
Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.
At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.
Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.
Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.
COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.
In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.
“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”
A version of this article first appeared on WebMD.com.
Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.
Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.
“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”
In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.
Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.
At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.
Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.
Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.
COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.
In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.
“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”
A version of this article first appeared on WebMD.com.
Obstetric units place twice as many wrong-patient orders as medical-surgical units
Clinicians in obstetric units place nearly twice as many wrong-patient orders as their medical-surgical counterparts, based on a retrospective look at more than 1.3 million orders.
These findings suggest that obstetric patients are at particular risk for this type of medical error, and that steps are needed to address obstetric clinical culture, work flow, and electronic medical record interfaces, reported lead author Adina R. Kern-Goldberger, MD, of the department of obstetrics and gynecology at the University of Pennsylvania, Philadelphia, and colleagues.
The root of the issue may come from the very nature of obstetrics, and the homogeneity of the patient population, they wrote in Obstetrics & Gynecology.
“Obstetrics is a unique clinical environment because all patients are admitted with a common diagnosis – pregnancy – and have much more overlap in demographic characteristics than a typical inpatient unit given that they are all females of reproductive age,” the investigators wrote. “The labor and delivery environment also is distinct in the hospital given its dynamic tempo and unpredictable work flow. There also is the added risk of neonates typically being registered in the hospital record under the mother’s name after birth. This generates abundant opportunity for errors in order placement, both between obstetric patients and between postpartum patients and their newborns.”
To determine the relative magnitude of this risk, Dr. Kern-Goldberger and colleagues analyzed EMRs from 45,436 obstetric patients and 12,915 medical-surgical patients at “a large, urban, integrated health system in New York City,” including 1,329,463 order sessions placed between 2016 and 2018.
The primary outcome was near-miss wrong-patient orders, which were identified by the Wrong-Patient Retract-and-Reorder measure.
“The measure uses an electronic query to detect retract-and-reorder events, defined as one or more orders placed for patient A, canceled by the same clinician within 10 minutes, and reordered by the same clinician for patient B within the next 10 minutes,” the investigators wrote.In obstetric units, 79.5 wrong-patient orders were placed per 100,000 order sessions, which was 98% higher than the rate of 42.3 wrong-patient orders per 100,000 order sessions in medical-surgical units (odds ratio, 1.98; 95% confidence interval, 1.64-2.39), a disparity that was observed across clinician types and times of day.Advanced practice clinicians in obstetrics placed 47.3 wrong-patient orders per 100,000 order sessions, which was significantly lower than that of their colleagues: attending physicians (127.0 per 100,000) and house staff (119.9 per 100,000).
Wrong-patient orders in obstetrics most often involved medication (73.2 per 100,000), particularly nifedipine, antibiotics, tocolytics, and nonoxytocin uterotonics. The “other” category, including but not limited to lab studies and nursing orders, was associated with 51.0 wrong-patient orders per 100,000 order sessions, while errors in diagnostic imaging orders followed distantly behind, at a rate of 5.7 per 1000,000.
“Although the obstetric clinical environment – particularly labor and delivery – is vibrant and frequently chaotic, it is critical to establish a calm, orderly, and safe culture around order entry,” the investigators wrote. “This, combined with efforts to improve house staff work flow and to optimize EMR interfaces, is likely to help mitigate the threat of wrong order errors to patient care and ultimately improve maternal health and safety.”
According to Catherine D. Cansino, MD, associate clinical professor of obstetrics and gynecology at UC Davis (Calif.) Health, the findings highlight the value of medical informatics while revealing a need to improve EMR interfaces.
“Medical informatics is a growing field and expertise among ob.gyns. is very important,” Dr. Cansino said in an interview. “This study by Kern-Goldberger and colleagues highlights the vulnerability of our EMR systems (and our patients, indirectly) when medical informatics systems are not optimized. The investigators present a study that advocates for greater emphasis on optimizing such systems in obstetrics units, especially in the context of high acuity settings such as obstetrics, compared to medical-surgical units. Appropriately, the study highlights the avoided harm when correcting medical errors for obstetric patients since such errors potentially affect both the delivering patient and the newborn.”
The study was funded by AHRQ. One coauthor disclosed funding from the Icahn School of Medicine at Mount Sinai, Georgetown University, the National Institutes of Health – Office of Scientific Review, and the Social Science Research Council. Another reported funding from Roche.
Clinicians in obstetric units place nearly twice as many wrong-patient orders as their medical-surgical counterparts, based on a retrospective look at more than 1.3 million orders.
These findings suggest that obstetric patients are at particular risk for this type of medical error, and that steps are needed to address obstetric clinical culture, work flow, and electronic medical record interfaces, reported lead author Adina R. Kern-Goldberger, MD, of the department of obstetrics and gynecology at the University of Pennsylvania, Philadelphia, and colleagues.
The root of the issue may come from the very nature of obstetrics, and the homogeneity of the patient population, they wrote in Obstetrics & Gynecology.
“Obstetrics is a unique clinical environment because all patients are admitted with a common diagnosis – pregnancy – and have much more overlap in demographic characteristics than a typical inpatient unit given that they are all females of reproductive age,” the investigators wrote. “The labor and delivery environment also is distinct in the hospital given its dynamic tempo and unpredictable work flow. There also is the added risk of neonates typically being registered in the hospital record under the mother’s name after birth. This generates abundant opportunity for errors in order placement, both between obstetric patients and between postpartum patients and their newborns.”
To determine the relative magnitude of this risk, Dr. Kern-Goldberger and colleagues analyzed EMRs from 45,436 obstetric patients and 12,915 medical-surgical patients at “a large, urban, integrated health system in New York City,” including 1,329,463 order sessions placed between 2016 and 2018.
The primary outcome was near-miss wrong-patient orders, which were identified by the Wrong-Patient Retract-and-Reorder measure.
“The measure uses an electronic query to detect retract-and-reorder events, defined as one or more orders placed for patient A, canceled by the same clinician within 10 minutes, and reordered by the same clinician for patient B within the next 10 minutes,” the investigators wrote.In obstetric units, 79.5 wrong-patient orders were placed per 100,000 order sessions, which was 98% higher than the rate of 42.3 wrong-patient orders per 100,000 order sessions in medical-surgical units (odds ratio, 1.98; 95% confidence interval, 1.64-2.39), a disparity that was observed across clinician types and times of day.Advanced practice clinicians in obstetrics placed 47.3 wrong-patient orders per 100,000 order sessions, which was significantly lower than that of their colleagues: attending physicians (127.0 per 100,000) and house staff (119.9 per 100,000).
Wrong-patient orders in obstetrics most often involved medication (73.2 per 100,000), particularly nifedipine, antibiotics, tocolytics, and nonoxytocin uterotonics. The “other” category, including but not limited to lab studies and nursing orders, was associated with 51.0 wrong-patient orders per 100,000 order sessions, while errors in diagnostic imaging orders followed distantly behind, at a rate of 5.7 per 1000,000.
“Although the obstetric clinical environment – particularly labor and delivery – is vibrant and frequently chaotic, it is critical to establish a calm, orderly, and safe culture around order entry,” the investigators wrote. “This, combined with efforts to improve house staff work flow and to optimize EMR interfaces, is likely to help mitigate the threat of wrong order errors to patient care and ultimately improve maternal health and safety.”
According to Catherine D. Cansino, MD, associate clinical professor of obstetrics and gynecology at UC Davis (Calif.) Health, the findings highlight the value of medical informatics while revealing a need to improve EMR interfaces.
“Medical informatics is a growing field and expertise among ob.gyns. is very important,” Dr. Cansino said in an interview. “This study by Kern-Goldberger and colleagues highlights the vulnerability of our EMR systems (and our patients, indirectly) when medical informatics systems are not optimized. The investigators present a study that advocates for greater emphasis on optimizing such systems in obstetrics units, especially in the context of high acuity settings such as obstetrics, compared to medical-surgical units. Appropriately, the study highlights the avoided harm when correcting medical errors for obstetric patients since such errors potentially affect both the delivering patient and the newborn.”
The study was funded by AHRQ. One coauthor disclosed funding from the Icahn School of Medicine at Mount Sinai, Georgetown University, the National Institutes of Health – Office of Scientific Review, and the Social Science Research Council. Another reported funding from Roche.
Clinicians in obstetric units place nearly twice as many wrong-patient orders as their medical-surgical counterparts, based on a retrospective look at more than 1.3 million orders.
These findings suggest that obstetric patients are at particular risk for this type of medical error, and that steps are needed to address obstetric clinical culture, work flow, and electronic medical record interfaces, reported lead author Adina R. Kern-Goldberger, MD, of the department of obstetrics and gynecology at the University of Pennsylvania, Philadelphia, and colleagues.
The root of the issue may come from the very nature of obstetrics, and the homogeneity of the patient population, they wrote in Obstetrics & Gynecology.
“Obstetrics is a unique clinical environment because all patients are admitted with a common diagnosis – pregnancy – and have much more overlap in demographic characteristics than a typical inpatient unit given that they are all females of reproductive age,” the investigators wrote. “The labor and delivery environment also is distinct in the hospital given its dynamic tempo and unpredictable work flow. There also is the added risk of neonates typically being registered in the hospital record under the mother’s name after birth. This generates abundant opportunity for errors in order placement, both between obstetric patients and between postpartum patients and their newborns.”
To determine the relative magnitude of this risk, Dr. Kern-Goldberger and colleagues analyzed EMRs from 45,436 obstetric patients and 12,915 medical-surgical patients at “a large, urban, integrated health system in New York City,” including 1,329,463 order sessions placed between 2016 and 2018.
The primary outcome was near-miss wrong-patient orders, which were identified by the Wrong-Patient Retract-and-Reorder measure.
“The measure uses an electronic query to detect retract-and-reorder events, defined as one or more orders placed for patient A, canceled by the same clinician within 10 minutes, and reordered by the same clinician for patient B within the next 10 minutes,” the investigators wrote.In obstetric units, 79.5 wrong-patient orders were placed per 100,000 order sessions, which was 98% higher than the rate of 42.3 wrong-patient orders per 100,000 order sessions in medical-surgical units (odds ratio, 1.98; 95% confidence interval, 1.64-2.39), a disparity that was observed across clinician types and times of day.Advanced practice clinicians in obstetrics placed 47.3 wrong-patient orders per 100,000 order sessions, which was significantly lower than that of their colleagues: attending physicians (127.0 per 100,000) and house staff (119.9 per 100,000).
Wrong-patient orders in obstetrics most often involved medication (73.2 per 100,000), particularly nifedipine, antibiotics, tocolytics, and nonoxytocin uterotonics. The “other” category, including but not limited to lab studies and nursing orders, was associated with 51.0 wrong-patient orders per 100,000 order sessions, while errors in diagnostic imaging orders followed distantly behind, at a rate of 5.7 per 1000,000.
“Although the obstetric clinical environment – particularly labor and delivery – is vibrant and frequently chaotic, it is critical to establish a calm, orderly, and safe culture around order entry,” the investigators wrote. “This, combined with efforts to improve house staff work flow and to optimize EMR interfaces, is likely to help mitigate the threat of wrong order errors to patient care and ultimately improve maternal health and safety.”
According to Catherine D. Cansino, MD, associate clinical professor of obstetrics and gynecology at UC Davis (Calif.) Health, the findings highlight the value of medical informatics while revealing a need to improve EMR interfaces.
“Medical informatics is a growing field and expertise among ob.gyns. is very important,” Dr. Cansino said in an interview. “This study by Kern-Goldberger and colleagues highlights the vulnerability of our EMR systems (and our patients, indirectly) when medical informatics systems are not optimized. The investigators present a study that advocates for greater emphasis on optimizing such systems in obstetrics units, especially in the context of high acuity settings such as obstetrics, compared to medical-surgical units. Appropriately, the study highlights the avoided harm when correcting medical errors for obstetric patients since such errors potentially affect both the delivering patient and the newborn.”
The study was funded by AHRQ. One coauthor disclosed funding from the Icahn School of Medicine at Mount Sinai, Georgetown University, the National Institutes of Health – Office of Scientific Review, and the Social Science Research Council. Another reported funding from Roche.
FROM OBSTETRICS & GYNECOLOGY
Targeted CLL treatments found effective in managing associated autoimmune cytopenias
Newer targeted drugs for chronic lymphocytic leukemia also appear to have a beneficial impact on underlying autoimmune cytopenias (AICs), results of a large retrospective study suggest.
Many autoimmune cytopenias improved or resolved during treatment with ibrutinib, idelalisib, or venetoclax, according to authors of the study, which appears in the journal Blood.
Treatment-emergent autoimmune cytopenias were seen in a “negligible portion” of patients overall, according to the report. The prevalence was about 1% each for patients treated with ibrutinib or idelalisib, though seen more frequently (at 7%) among patients who received venetoclax.
Nevertheless, treatment-emergent autoimmune cytopenias were “easily manageable” without interventions such as steroids and rituximab, and without need to interrupt the targeted treatment for chronic lymphocytic leukemia (CLL), according to the authors, led by Candida Vitale, MD, PhD, of the department of molecular biotechnology and health sciences at the University of Torino in Italy.
“Ibrutinib, idelalisib, and venetoclax have a beneficial impact on CLL-related preexisting AICs, achieving in most patients, in parallel with the consolidated antitumor efficacy, an effective control of the autoimmune phenomena,” Dr. Vitale and coauthors wrote in their report.
Study results
The retrospective study included 815 patients, of whom 572 were treated with ibrutinib, 143 with idelalisib plus rituximab, and 100 with venetoclax. Nine percent of ibrutinib-treated patients and 12% of venetoclax-treated patients also received an anti-CD20 monoclonal antibody, rituximab or obinutuzumab.
One hundred and four patients (13%) had preexisting autoimmune cytopenias, though the majority were resolved or controlled at the time targeted therapy was started.
Of patients with autoimmune cytopenias that were unresolved at the beginning of targeted therapy, 80% improved or resolved after starting targeted treatment, authors reported.
Most patients who developed autoimmune cytopenias on treatment had high-risk features such as unmutated IGHV, del(17)p, or TP53 mutation, according to the report.
Those treatment-emergent autoimmune cytopenias were seen in 1% of the ibrutinib group, 0.9% of the idelalisib group, and 7% of the venetoclax group. Out of 12 total treatment-emergent autoimmune cytopenias, all but 2 were resolved or controlled with dose reductions or temporary suspensions and use of steroids or rituximab, the report shows.
The higher incidence of autoimmune cytopenias in the venetoclax group held steady even when considering just the patients who had relapsed/refractory disease or had at least two prior lines of therapy, suggesting a “more meaningful” incidence, compared to what was observed for ibrutinib and idelalisib, the investigators said.
“However, the risk of autoimmune cytopenia episodes should not limit the use of venetoclax, considering the strong efficacy of this drug in treating patients with CLL, including those with high-risk features, and the possibility of effectively managing autoimmune complications, mostly without treatment interruption,” they concluded in their report.
Implications for patients with CLL
Findings of this study indicate that targeted therapies are effective for managing both CLL and autoimmune cytopenias, according to Carol Moreno, MD, PhD, of Hospital Sant Pau in Barcelona.
Moreover, the targeted therapies do not appear to change the overall prevalence of autoimmune cytopenias, compared to untreated patients, Dr. Moreno said in a commentary on the findings also published in Blood.
“These results are consistent with the concept that targeted therapies are not associated with a higher risk of autoimmune cytopenias, and that, if present, can be managed with immunosuppressive agents,” she wrote.
Autoimmune cytopenias and CLL
Autoimmune cytopenias are a relatively common complication of CLL, occurring in 5%-9% of CLL patients, Dr. Vitale and coauthors said in their report. The most common presentations include autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP).
Evidence from earlier studies suggests that treatment for CLL may trigger autoimmune cytopenias. Results of retrospective studies in the 1990s linked single-agent fludarabine to increased risk of AIHA, Dr. Moreno said in the commentary.
However, subsequent studies showed that fludarabine plus cyclophosphamide (FC) and fludarabine, cyclophosphamide, and rituximab (FCR) were associated with low proportions of AIHA.
“Taken together, these results convincingly suggest that rather than treatment, it is the lack of response to it that conveys a higher risk of AIC,” Dr. Moreno wrote.
Management considerations
There are currently no clinical practice guidelines that advise on how to manage patients who develop AICs during targeted treatment for CLL, Dr. Vitale and colleagues said in their report.
However, this new study data may help inform management of patients with CLL and an autoimmune cytopenia, Dr. Moreno said in the commentary.
If the patient doesn’t immediately require CLL treatment, patients can be managed according to existing guidelines for AIHA and ITP, she said. “Nonresponding patients should be given CLL therapy,” she added.
For CLL patients who do require therapy and have a preexisting or treatment-emergent AIC, a “CLL-oriented” treatment approach could be considered, according to Dr. Moreno.
“A reasonable approach consists of a short course (2 to 4 weeks) of corticosteroids followed by effective CLL therapy (i.e., FCR, bendamustine plus rituximab or ibrutinib), depending on the clinical situation,” she added.
Dr. Vitale reported receiving consultancy fees from Janssen outside the submitted work. Dr. Moreno declared no competing financial interests related to her commentary.
Newer targeted drugs for chronic lymphocytic leukemia also appear to have a beneficial impact on underlying autoimmune cytopenias (AICs), results of a large retrospective study suggest.
Many autoimmune cytopenias improved or resolved during treatment with ibrutinib, idelalisib, or venetoclax, according to authors of the study, which appears in the journal Blood.
Treatment-emergent autoimmune cytopenias were seen in a “negligible portion” of patients overall, according to the report. The prevalence was about 1% each for patients treated with ibrutinib or idelalisib, though seen more frequently (at 7%) among patients who received venetoclax.
Nevertheless, treatment-emergent autoimmune cytopenias were “easily manageable” without interventions such as steroids and rituximab, and without need to interrupt the targeted treatment for chronic lymphocytic leukemia (CLL), according to the authors, led by Candida Vitale, MD, PhD, of the department of molecular biotechnology and health sciences at the University of Torino in Italy.
“Ibrutinib, idelalisib, and venetoclax have a beneficial impact on CLL-related preexisting AICs, achieving in most patients, in parallel with the consolidated antitumor efficacy, an effective control of the autoimmune phenomena,” Dr. Vitale and coauthors wrote in their report.
Study results
The retrospective study included 815 patients, of whom 572 were treated with ibrutinib, 143 with idelalisib plus rituximab, and 100 with venetoclax. Nine percent of ibrutinib-treated patients and 12% of venetoclax-treated patients also received an anti-CD20 monoclonal antibody, rituximab or obinutuzumab.
One hundred and four patients (13%) had preexisting autoimmune cytopenias, though the majority were resolved or controlled at the time targeted therapy was started.
Of patients with autoimmune cytopenias that were unresolved at the beginning of targeted therapy, 80% improved or resolved after starting targeted treatment, authors reported.
Most patients who developed autoimmune cytopenias on treatment had high-risk features such as unmutated IGHV, del(17)p, or TP53 mutation, according to the report.
Those treatment-emergent autoimmune cytopenias were seen in 1% of the ibrutinib group, 0.9% of the idelalisib group, and 7% of the venetoclax group. Out of 12 total treatment-emergent autoimmune cytopenias, all but 2 were resolved or controlled with dose reductions or temporary suspensions and use of steroids or rituximab, the report shows.
The higher incidence of autoimmune cytopenias in the venetoclax group held steady even when considering just the patients who had relapsed/refractory disease or had at least two prior lines of therapy, suggesting a “more meaningful” incidence, compared to what was observed for ibrutinib and idelalisib, the investigators said.
“However, the risk of autoimmune cytopenia episodes should not limit the use of venetoclax, considering the strong efficacy of this drug in treating patients with CLL, including those with high-risk features, and the possibility of effectively managing autoimmune complications, mostly without treatment interruption,” they concluded in their report.
Implications for patients with CLL
Findings of this study indicate that targeted therapies are effective for managing both CLL and autoimmune cytopenias, according to Carol Moreno, MD, PhD, of Hospital Sant Pau in Barcelona.
Moreover, the targeted therapies do not appear to change the overall prevalence of autoimmune cytopenias, compared to untreated patients, Dr. Moreno said in a commentary on the findings also published in Blood.
“These results are consistent with the concept that targeted therapies are not associated with a higher risk of autoimmune cytopenias, and that, if present, can be managed with immunosuppressive agents,” she wrote.
Autoimmune cytopenias and CLL
Autoimmune cytopenias are a relatively common complication of CLL, occurring in 5%-9% of CLL patients, Dr. Vitale and coauthors said in their report. The most common presentations include autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP).
Evidence from earlier studies suggests that treatment for CLL may trigger autoimmune cytopenias. Results of retrospective studies in the 1990s linked single-agent fludarabine to increased risk of AIHA, Dr. Moreno said in the commentary.
However, subsequent studies showed that fludarabine plus cyclophosphamide (FC) and fludarabine, cyclophosphamide, and rituximab (FCR) were associated with low proportions of AIHA.
“Taken together, these results convincingly suggest that rather than treatment, it is the lack of response to it that conveys a higher risk of AIC,” Dr. Moreno wrote.
Management considerations
There are currently no clinical practice guidelines that advise on how to manage patients who develop AICs during targeted treatment for CLL, Dr. Vitale and colleagues said in their report.
However, this new study data may help inform management of patients with CLL and an autoimmune cytopenia, Dr. Moreno said in the commentary.
If the patient doesn’t immediately require CLL treatment, patients can be managed according to existing guidelines for AIHA and ITP, she said. “Nonresponding patients should be given CLL therapy,” she added.
For CLL patients who do require therapy and have a preexisting or treatment-emergent AIC, a “CLL-oriented” treatment approach could be considered, according to Dr. Moreno.
“A reasonable approach consists of a short course (2 to 4 weeks) of corticosteroids followed by effective CLL therapy (i.e., FCR, bendamustine plus rituximab or ibrutinib), depending on the clinical situation,” she added.
Dr. Vitale reported receiving consultancy fees from Janssen outside the submitted work. Dr. Moreno declared no competing financial interests related to her commentary.
Newer targeted drugs for chronic lymphocytic leukemia also appear to have a beneficial impact on underlying autoimmune cytopenias (AICs), results of a large retrospective study suggest.
Many autoimmune cytopenias improved or resolved during treatment with ibrutinib, idelalisib, or venetoclax, according to authors of the study, which appears in the journal Blood.
Treatment-emergent autoimmune cytopenias were seen in a “negligible portion” of patients overall, according to the report. The prevalence was about 1% each for patients treated with ibrutinib or idelalisib, though seen more frequently (at 7%) among patients who received venetoclax.
Nevertheless, treatment-emergent autoimmune cytopenias were “easily manageable” without interventions such as steroids and rituximab, and without need to interrupt the targeted treatment for chronic lymphocytic leukemia (CLL), according to the authors, led by Candida Vitale, MD, PhD, of the department of molecular biotechnology and health sciences at the University of Torino in Italy.
“Ibrutinib, idelalisib, and venetoclax have a beneficial impact on CLL-related preexisting AICs, achieving in most patients, in parallel with the consolidated antitumor efficacy, an effective control of the autoimmune phenomena,” Dr. Vitale and coauthors wrote in their report.
Study results
The retrospective study included 815 patients, of whom 572 were treated with ibrutinib, 143 with idelalisib plus rituximab, and 100 with venetoclax. Nine percent of ibrutinib-treated patients and 12% of venetoclax-treated patients also received an anti-CD20 monoclonal antibody, rituximab or obinutuzumab.
One hundred and four patients (13%) had preexisting autoimmune cytopenias, though the majority were resolved or controlled at the time targeted therapy was started.
Of patients with autoimmune cytopenias that were unresolved at the beginning of targeted therapy, 80% improved or resolved after starting targeted treatment, authors reported.
Most patients who developed autoimmune cytopenias on treatment had high-risk features such as unmutated IGHV, del(17)p, or TP53 mutation, according to the report.
Those treatment-emergent autoimmune cytopenias were seen in 1% of the ibrutinib group, 0.9% of the idelalisib group, and 7% of the venetoclax group. Out of 12 total treatment-emergent autoimmune cytopenias, all but 2 were resolved or controlled with dose reductions or temporary suspensions and use of steroids or rituximab, the report shows.
The higher incidence of autoimmune cytopenias in the venetoclax group held steady even when considering just the patients who had relapsed/refractory disease or had at least two prior lines of therapy, suggesting a “more meaningful” incidence, compared to what was observed for ibrutinib and idelalisib, the investigators said.
“However, the risk of autoimmune cytopenia episodes should not limit the use of venetoclax, considering the strong efficacy of this drug in treating patients with CLL, including those with high-risk features, and the possibility of effectively managing autoimmune complications, mostly without treatment interruption,” they concluded in their report.
Implications for patients with CLL
Findings of this study indicate that targeted therapies are effective for managing both CLL and autoimmune cytopenias, according to Carol Moreno, MD, PhD, of Hospital Sant Pau in Barcelona.
Moreover, the targeted therapies do not appear to change the overall prevalence of autoimmune cytopenias, compared to untreated patients, Dr. Moreno said in a commentary on the findings also published in Blood.
“These results are consistent with the concept that targeted therapies are not associated with a higher risk of autoimmune cytopenias, and that, if present, can be managed with immunosuppressive agents,” she wrote.
Autoimmune cytopenias and CLL
Autoimmune cytopenias are a relatively common complication of CLL, occurring in 5%-9% of CLL patients, Dr. Vitale and coauthors said in their report. The most common presentations include autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP).
Evidence from earlier studies suggests that treatment for CLL may trigger autoimmune cytopenias. Results of retrospective studies in the 1990s linked single-agent fludarabine to increased risk of AIHA, Dr. Moreno said in the commentary.
However, subsequent studies showed that fludarabine plus cyclophosphamide (FC) and fludarabine, cyclophosphamide, and rituximab (FCR) were associated with low proportions of AIHA.
“Taken together, these results convincingly suggest that rather than treatment, it is the lack of response to it that conveys a higher risk of AIC,” Dr. Moreno wrote.
Management considerations
There are currently no clinical practice guidelines that advise on how to manage patients who develop AICs during targeted treatment for CLL, Dr. Vitale and colleagues said in their report.
However, this new study data may help inform management of patients with CLL and an autoimmune cytopenia, Dr. Moreno said in the commentary.
If the patient doesn’t immediately require CLL treatment, patients can be managed according to existing guidelines for AIHA and ITP, she said. “Nonresponding patients should be given CLL therapy,” she added.
For CLL patients who do require therapy and have a preexisting or treatment-emergent AIC, a “CLL-oriented” treatment approach could be considered, according to Dr. Moreno.
“A reasonable approach consists of a short course (2 to 4 weeks) of corticosteroids followed by effective CLL therapy (i.e., FCR, bendamustine plus rituximab or ibrutinib), depending on the clinical situation,” she added.
Dr. Vitale reported receiving consultancy fees from Janssen outside the submitted work. Dr. Moreno declared no competing financial interests related to her commentary.
FROM BLOOD
Bullying in academic medicine rife, underreported
Bullying in academic medicine, especially among women, is rife, underreported, and remains largely unaddressed, new research suggests.
Investigators reviewed close to 70 studies, encompassing over 82,000 medical consultants or trainees in academic medical settings, and found that men were identified as the most common perpetrators – close to 70% of respondents – whereas women were the most common victims (56%).
Collectively, respondents in all of the studies identified the most common bullies to be consultants (54%), followed by residents (22%), and nurses (15%).
Disturbingly, less than one-third of victims overall reported that they were bullied, and close to 60% who formally reported the abuse said they did not have a positive outcome.
“We found that bullies are commonly men and senior consultants, while more than half of their victims are women,” senior author Harriette G.C. Van Spall, MD, MPH, associate professor of medicine and director of e-health and virtual care, Division of Cardiology, McMaster University, Hamilton, Ont., said in an interview.
“The greatest barriers to addressing academic bullying are the fear of reprisal, lack of impact of reporting, and non-enforcement of anti-bullying policies,” she added.
The study was published online July 12 in BMJ Open.
Personal experience
“Some behaviors were excruciating to deal with, protesting against them would bring more on, and every day was filled with dread. It took sheer will to show up at work to care for patients, to complete research I was leading, and to have hope, and my academic output, income, and personal well-being dropped during those years,” she added.
Dr. Van Spall thought the subject “merited research because our performance as clinicians, researchers, and educators relies on our work environment.”
To investigate, the researchers reviewed 68 studies (n = 82,349 respondents) conducted between 1999 and 2021 in academic medical settings, in which victims were either consultants or trainees. Many of the studies (31) were conducted in the U.S.
Other countries included the United Kingdom, Canada, Australia, Pakistan, Egypt, Iran, Turkey, New Zealand, Lithuania, Greece, India, Germany, Nigeria, Oman, and Finland.
Studies were required to describe the method and impact of bullying; characteristics of the perpetrators and victims; or interventions that were used to address the bullying.
“Bullying” was defined as “the abuse of authority by a perpetrator who targets the victim in an academic setting through punishing behaviors that include overwork, destabilization, and isolation in order to impede the education or career of the target.”
Systemic sexism
Bullying behaviors, reported in 28 studies (n = 35,779 respondents), were grouped into destabilization, threats to professional status, overwork, and isolation, with overwork found to be the most common form of bullying.
The most common impact of being bullied was psychological distress, reported by 39.1% of respondents in 14 studies, followed by considerations of quitting (35.9%; 7 studies), and worsening of clinical performance (34.6%, 8 studies).
“Among demographic groups, men were identified as the most common perpetrators (67.2% of 4,722 respondents in 5 studies) and women the most common victims (56.2% of 15,246 respondents in 27 studies),” the authors report.
“Academic medicine in many institutions is encumbered by systemic sexism that is evident in processes around remuneration, recognition, opportunities for advancement, and leadership positions,” said Dr. Van Spall.
“There are fewer women at decision-making tables in academic medicine, the climb is uphill at the best of times, and women are likely easier targets for bullies, as their voices are easier to drown out,” she added.
She noted that many men do “exhibit wonderful attributes of professionalism and decency,” but “some in positions of power are given impunity by virtue of other accomplishments.”
Multiple deterrents
Thirty-one studies (n = 15,868) described characteristics of the bullies and showed the most common to be consultants (53.6% [30 studies]), residents (22% [22 studies]), and nurses (14.9% [21 studies]).
Only a minority of victims (28.9% of 9,410 victims [10 studies]) formally reported the bullying. The researchers identified multiple deterrents to reporting.
When a formal complaint was submitted (n = 1,139 respondents), it most frequently had no perceived effect (35.6%); more than one-fifth (21.9%) experienced worsening of the bullying, and only 13.7% reported improvement.
The common institutional facilitators of bullying, described in 25 studies, included lack of enforcement of anti-bullying policies (13 studies), the hierarchical structure of medicine (7 studies), and normalization of bullying (10 studies).
Forty-nine studies looked at strategies to address academic bullying, including anti-bullying policies, mandatory workshops on mistreatment, establishing an anti-bullying oversight committee, and institutional support for victims. However, the studies testing the effectiveness of these interventions “had a high risk of bias.”
Support available
Commenting on the research for this news organization, Roberta Gebhard, DO, past president of the American Medical Women’s Association (AMWA) and a member of the advisory board for Physician Just Equity, called it a “good study, large, international, and well-written.”
Dr. Gebhard, a member of the Governing Council for the American Medical Association Women Physician Section, was not associated with this study but said she is currently researching women who left medical school and residency.
“A common reason for leaving is being bullied. Bullying is often not reported and if reported, often not addressed. Or, if addressed, the person who reports it is often retaliated against, which is a common experience, especially in women.”
She advised female physicians who are bullied to get support from other female physicians – for example, by joining the AMWA, which has an online women’s leadership group.
“Having other women physicians throughout the country you can call for advice and support can be helpful,” said Dr. Gebhard, a family practice physician based in Grand Island, New York.
Dr. Van Spall receives support from the Canadian Institutes of Health Research, the Heart and Stroke Foundation, the Women As One Escalator Award, and McMaster Department of Medicine. The study authors and Dr. Gebhard have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Bullying in academic medicine, especially among women, is rife, underreported, and remains largely unaddressed, new research suggests.
Investigators reviewed close to 70 studies, encompassing over 82,000 medical consultants or trainees in academic medical settings, and found that men were identified as the most common perpetrators – close to 70% of respondents – whereas women were the most common victims (56%).
Collectively, respondents in all of the studies identified the most common bullies to be consultants (54%), followed by residents (22%), and nurses (15%).
Disturbingly, less than one-third of victims overall reported that they were bullied, and close to 60% who formally reported the abuse said they did not have a positive outcome.
“We found that bullies are commonly men and senior consultants, while more than half of their victims are women,” senior author Harriette G.C. Van Spall, MD, MPH, associate professor of medicine and director of e-health and virtual care, Division of Cardiology, McMaster University, Hamilton, Ont., said in an interview.
“The greatest barriers to addressing academic bullying are the fear of reprisal, lack of impact of reporting, and non-enforcement of anti-bullying policies,” she added.
The study was published online July 12 in BMJ Open.
Personal experience
“Some behaviors were excruciating to deal with, protesting against them would bring more on, and every day was filled with dread. It took sheer will to show up at work to care for patients, to complete research I was leading, and to have hope, and my academic output, income, and personal well-being dropped during those years,” she added.
Dr. Van Spall thought the subject “merited research because our performance as clinicians, researchers, and educators relies on our work environment.”
To investigate, the researchers reviewed 68 studies (n = 82,349 respondents) conducted between 1999 and 2021 in academic medical settings, in which victims were either consultants or trainees. Many of the studies (31) were conducted in the U.S.
Other countries included the United Kingdom, Canada, Australia, Pakistan, Egypt, Iran, Turkey, New Zealand, Lithuania, Greece, India, Germany, Nigeria, Oman, and Finland.
Studies were required to describe the method and impact of bullying; characteristics of the perpetrators and victims; or interventions that were used to address the bullying.
“Bullying” was defined as “the abuse of authority by a perpetrator who targets the victim in an academic setting through punishing behaviors that include overwork, destabilization, and isolation in order to impede the education or career of the target.”
Systemic sexism
Bullying behaviors, reported in 28 studies (n = 35,779 respondents), were grouped into destabilization, threats to professional status, overwork, and isolation, with overwork found to be the most common form of bullying.
The most common impact of being bullied was psychological distress, reported by 39.1% of respondents in 14 studies, followed by considerations of quitting (35.9%; 7 studies), and worsening of clinical performance (34.6%, 8 studies).
“Among demographic groups, men were identified as the most common perpetrators (67.2% of 4,722 respondents in 5 studies) and women the most common victims (56.2% of 15,246 respondents in 27 studies),” the authors report.
“Academic medicine in many institutions is encumbered by systemic sexism that is evident in processes around remuneration, recognition, opportunities for advancement, and leadership positions,” said Dr. Van Spall.
“There are fewer women at decision-making tables in academic medicine, the climb is uphill at the best of times, and women are likely easier targets for bullies, as their voices are easier to drown out,” she added.
She noted that many men do “exhibit wonderful attributes of professionalism and decency,” but “some in positions of power are given impunity by virtue of other accomplishments.”
Multiple deterrents
Thirty-one studies (n = 15,868) described characteristics of the bullies and showed the most common to be consultants (53.6% [30 studies]), residents (22% [22 studies]), and nurses (14.9% [21 studies]).
Only a minority of victims (28.9% of 9,410 victims [10 studies]) formally reported the bullying. The researchers identified multiple deterrents to reporting.
When a formal complaint was submitted (n = 1,139 respondents), it most frequently had no perceived effect (35.6%); more than one-fifth (21.9%) experienced worsening of the bullying, and only 13.7% reported improvement.
The common institutional facilitators of bullying, described in 25 studies, included lack of enforcement of anti-bullying policies (13 studies), the hierarchical structure of medicine (7 studies), and normalization of bullying (10 studies).
Forty-nine studies looked at strategies to address academic bullying, including anti-bullying policies, mandatory workshops on mistreatment, establishing an anti-bullying oversight committee, and institutional support for victims. However, the studies testing the effectiveness of these interventions “had a high risk of bias.”
Support available
Commenting on the research for this news organization, Roberta Gebhard, DO, past president of the American Medical Women’s Association (AMWA) and a member of the advisory board for Physician Just Equity, called it a “good study, large, international, and well-written.”
Dr. Gebhard, a member of the Governing Council for the American Medical Association Women Physician Section, was not associated with this study but said she is currently researching women who left medical school and residency.
“A common reason for leaving is being bullied. Bullying is often not reported and if reported, often not addressed. Or, if addressed, the person who reports it is often retaliated against, which is a common experience, especially in women.”
She advised female physicians who are bullied to get support from other female physicians – for example, by joining the AMWA, which has an online women’s leadership group.
“Having other women physicians throughout the country you can call for advice and support can be helpful,” said Dr. Gebhard, a family practice physician based in Grand Island, New York.
Dr. Van Spall receives support from the Canadian Institutes of Health Research, the Heart and Stroke Foundation, the Women As One Escalator Award, and McMaster Department of Medicine. The study authors and Dr. Gebhard have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Bullying in academic medicine, especially among women, is rife, underreported, and remains largely unaddressed, new research suggests.
Investigators reviewed close to 70 studies, encompassing over 82,000 medical consultants or trainees in academic medical settings, and found that men were identified as the most common perpetrators – close to 70% of respondents – whereas women were the most common victims (56%).
Collectively, respondents in all of the studies identified the most common bullies to be consultants (54%), followed by residents (22%), and nurses (15%).
Disturbingly, less than one-third of victims overall reported that they were bullied, and close to 60% who formally reported the abuse said they did not have a positive outcome.
“We found that bullies are commonly men and senior consultants, while more than half of their victims are women,” senior author Harriette G.C. Van Spall, MD, MPH, associate professor of medicine and director of e-health and virtual care, Division of Cardiology, McMaster University, Hamilton, Ont., said in an interview.
“The greatest barriers to addressing academic bullying are the fear of reprisal, lack of impact of reporting, and non-enforcement of anti-bullying policies,” she added.
The study was published online July 12 in BMJ Open.
Personal experience
“Some behaviors were excruciating to deal with, protesting against them would bring more on, and every day was filled with dread. It took sheer will to show up at work to care for patients, to complete research I was leading, and to have hope, and my academic output, income, and personal well-being dropped during those years,” she added.
Dr. Van Spall thought the subject “merited research because our performance as clinicians, researchers, and educators relies on our work environment.”
To investigate, the researchers reviewed 68 studies (n = 82,349 respondents) conducted between 1999 and 2021 in academic medical settings, in which victims were either consultants or trainees. Many of the studies (31) were conducted in the U.S.
Other countries included the United Kingdom, Canada, Australia, Pakistan, Egypt, Iran, Turkey, New Zealand, Lithuania, Greece, India, Germany, Nigeria, Oman, and Finland.
Studies were required to describe the method and impact of bullying; characteristics of the perpetrators and victims; or interventions that were used to address the bullying.
“Bullying” was defined as “the abuse of authority by a perpetrator who targets the victim in an academic setting through punishing behaviors that include overwork, destabilization, and isolation in order to impede the education or career of the target.”
Systemic sexism
Bullying behaviors, reported in 28 studies (n = 35,779 respondents), were grouped into destabilization, threats to professional status, overwork, and isolation, with overwork found to be the most common form of bullying.
The most common impact of being bullied was psychological distress, reported by 39.1% of respondents in 14 studies, followed by considerations of quitting (35.9%; 7 studies), and worsening of clinical performance (34.6%, 8 studies).
“Among demographic groups, men were identified as the most common perpetrators (67.2% of 4,722 respondents in 5 studies) and women the most common victims (56.2% of 15,246 respondents in 27 studies),” the authors report.
“Academic medicine in many institutions is encumbered by systemic sexism that is evident in processes around remuneration, recognition, opportunities for advancement, and leadership positions,” said Dr. Van Spall.
“There are fewer women at decision-making tables in academic medicine, the climb is uphill at the best of times, and women are likely easier targets for bullies, as their voices are easier to drown out,” she added.
She noted that many men do “exhibit wonderful attributes of professionalism and decency,” but “some in positions of power are given impunity by virtue of other accomplishments.”
Multiple deterrents
Thirty-one studies (n = 15,868) described characteristics of the bullies and showed the most common to be consultants (53.6% [30 studies]), residents (22% [22 studies]), and nurses (14.9% [21 studies]).
Only a minority of victims (28.9% of 9,410 victims [10 studies]) formally reported the bullying. The researchers identified multiple deterrents to reporting.
When a formal complaint was submitted (n = 1,139 respondents), it most frequently had no perceived effect (35.6%); more than one-fifth (21.9%) experienced worsening of the bullying, and only 13.7% reported improvement.
The common institutional facilitators of bullying, described in 25 studies, included lack of enforcement of anti-bullying policies (13 studies), the hierarchical structure of medicine (7 studies), and normalization of bullying (10 studies).
Forty-nine studies looked at strategies to address academic bullying, including anti-bullying policies, mandatory workshops on mistreatment, establishing an anti-bullying oversight committee, and institutional support for victims. However, the studies testing the effectiveness of these interventions “had a high risk of bias.”
Support available
Commenting on the research for this news organization, Roberta Gebhard, DO, past president of the American Medical Women’s Association (AMWA) and a member of the advisory board for Physician Just Equity, called it a “good study, large, international, and well-written.”
Dr. Gebhard, a member of the Governing Council for the American Medical Association Women Physician Section, was not associated with this study but said she is currently researching women who left medical school and residency.
“A common reason for leaving is being bullied. Bullying is often not reported and if reported, often not addressed. Or, if addressed, the person who reports it is often retaliated against, which is a common experience, especially in women.”
She advised female physicians who are bullied to get support from other female physicians – for example, by joining the AMWA, which has an online women’s leadership group.
“Having other women physicians throughout the country you can call for advice and support can be helpful,” said Dr. Gebhard, a family practice physician based in Grand Island, New York.
Dr. Van Spall receives support from the Canadian Institutes of Health Research, the Heart and Stroke Foundation, the Women As One Escalator Award, and McMaster Department of Medicine. The study authors and Dr. Gebhard have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Dupilumab safe, effective in kids 6-11 with moderate-to-severe asthma
Dupilumab (Dupixent, Sanofi and Regeneron) significantly reduced exacerbations compared with placebo in children ages 6-11 years who had moderate-to-severe asthma in a phase 3 trial.
A fully human monoclonal antibody, dupilumab also improved lung function versus placebo by week 12, an improvement that lasted the length of the 52-week trial.
Dupilumab previously had been shown to be safe and effective in adolescents and adults with moderate-to-severe asthma, patients 6 years and older with moderate-to-severe atopic dermatitis, and adults with chronic rhinosinusitis with nasal polyposis, but its safety and effectiveness for moderate-to-severe asthma in the 6-11 years age group was not known.
Results from the randomized, double-blind VOYAGE study conducted across several countries were presented Saturday, July 10, at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021.
Leonard B. Bacharier, MD, professor of pediatrics, allergy/immunology/pulmonary medicine at Vanderbilt University Medical Center in Nashville, Tennessee, presented the results from the trial, which was funded by Sanofi/Regeneron.
Researchers enrolled 408 children ages 6-11 years with uncontrolled moderate-to-severe asthma. Children on high-dose inhaled corticosteroids (ICS) alone or medium-to-high–dose ICS with a second controller were randomly assigned either to add-on subcutaneous dupilumab 100 mg or 200 mg, based on body weight at study start, or to placebo every 2 weeks for 52 weeks.
Analyses were done in two populations: 350 patients with markers of type 2 inflammation (baseline blood eosinophils ≥150 cells/μl or fractional exhaled nitric oxide [FeNO] ≥20 ppb) and 259 patients with baseline blood eosinophils ≥300 cells/µl.
“The primary endpoint was the annualized rate of severe asthma exacerbations,” Dr. Bacharier said. “The key secondary endpoint was change in percent predicted prebronchodilator FEV1 [forced expiratory volume at 1 second] from baseline to week 12.”
At week 12, the annualized severe asthma exacerbation rate was reduced by 59% (P < .0001) in children with blood eosinophils ≥300 cells/µL and results were similar in those with the type 2 inflammatory phenotype compared with placebo.
Results also indicate a favorable safety profile for dupilumab.
James M. Tracy, DO, an expert with the American College of Allergy, Asthma, and Immunology, told this news organization that adding the dupilumab option for children in the 6-11 age group is “huge.”
Dr. Tracy, who was not involved with the study, said although omalizumab (Xolair, Genentech) is also available for these children, dupilumab stands out because of the range of comorbidities it can treat.
“[Children] don’t have the same rhinosinusitis and polyposis that adults would have, but a lot of them have eczema, and this drug with multiple prongs is incredibly useful and addresses a broad array of allergic conditions,” Dr. Tracy said.
More than 90% of children in the study had at least one concurrent type 2 inflammatory condition, including atopic dermatitis and eosinophilic esophagitis. Dupilumab blocks the shared receptor for interleukin (IL)-4/IL-13, which are key drivers of type 2 inflammation in multiple diseases.
Dr. Tracy said that while dupilumab is not the only drug available to treat children 6-11 years with moderate-to-severe asthma, it is “a significant and unique addition to the armamentarium of the individual practitioner taking care of these very severe asthmatics in the 6-11 age group.”
Dupilumab also led to rapid and sustained improvement in lung function. At 12 weeks, children assigned dupilumab improved their lung function as measured by FEV1 by 5.21% (P = .0009), and that continued through the 52-week study period.
“What we know is the [improved lung function] effect is sustained. What we don’t know is how long you have to keep on the drug for a more permanent effect, which is an issue for all these biologics,” Tracy said.
Dr. Bacharier reported speaker fees and research support from Sanofi/Regeneron. Dr. Tracy has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Dupilumab (Dupixent, Sanofi and Regeneron) significantly reduced exacerbations compared with placebo in children ages 6-11 years who had moderate-to-severe asthma in a phase 3 trial.
A fully human monoclonal antibody, dupilumab also improved lung function versus placebo by week 12, an improvement that lasted the length of the 52-week trial.
Dupilumab previously had been shown to be safe and effective in adolescents and adults with moderate-to-severe asthma, patients 6 years and older with moderate-to-severe atopic dermatitis, and adults with chronic rhinosinusitis with nasal polyposis, but its safety and effectiveness for moderate-to-severe asthma in the 6-11 years age group was not known.
Results from the randomized, double-blind VOYAGE study conducted across several countries were presented Saturday, July 10, at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021.
Leonard B. Bacharier, MD, professor of pediatrics, allergy/immunology/pulmonary medicine at Vanderbilt University Medical Center in Nashville, Tennessee, presented the results from the trial, which was funded by Sanofi/Regeneron.
Researchers enrolled 408 children ages 6-11 years with uncontrolled moderate-to-severe asthma. Children on high-dose inhaled corticosteroids (ICS) alone or medium-to-high–dose ICS with a second controller were randomly assigned either to add-on subcutaneous dupilumab 100 mg or 200 mg, based on body weight at study start, or to placebo every 2 weeks for 52 weeks.
Analyses were done in two populations: 350 patients with markers of type 2 inflammation (baseline blood eosinophils ≥150 cells/μl or fractional exhaled nitric oxide [FeNO] ≥20 ppb) and 259 patients with baseline blood eosinophils ≥300 cells/µl.
“The primary endpoint was the annualized rate of severe asthma exacerbations,” Dr. Bacharier said. “The key secondary endpoint was change in percent predicted prebronchodilator FEV1 [forced expiratory volume at 1 second] from baseline to week 12.”
At week 12, the annualized severe asthma exacerbation rate was reduced by 59% (P < .0001) in children with blood eosinophils ≥300 cells/µL and results were similar in those with the type 2 inflammatory phenotype compared with placebo.
Results also indicate a favorable safety profile for dupilumab.
James M. Tracy, DO, an expert with the American College of Allergy, Asthma, and Immunology, told this news organization that adding the dupilumab option for children in the 6-11 age group is “huge.”
Dr. Tracy, who was not involved with the study, said although omalizumab (Xolair, Genentech) is also available for these children, dupilumab stands out because of the range of comorbidities it can treat.
“[Children] don’t have the same rhinosinusitis and polyposis that adults would have, but a lot of them have eczema, and this drug with multiple prongs is incredibly useful and addresses a broad array of allergic conditions,” Dr. Tracy said.
More than 90% of children in the study had at least one concurrent type 2 inflammatory condition, including atopic dermatitis and eosinophilic esophagitis. Dupilumab blocks the shared receptor for interleukin (IL)-4/IL-13, which are key drivers of type 2 inflammation in multiple diseases.
Dr. Tracy said that while dupilumab is not the only drug available to treat children 6-11 years with moderate-to-severe asthma, it is “a significant and unique addition to the armamentarium of the individual practitioner taking care of these very severe asthmatics in the 6-11 age group.”
Dupilumab also led to rapid and sustained improvement in lung function. At 12 weeks, children assigned dupilumab improved their lung function as measured by FEV1 by 5.21% (P = .0009), and that continued through the 52-week study period.
“What we know is the [improved lung function] effect is sustained. What we don’t know is how long you have to keep on the drug for a more permanent effect, which is an issue for all these biologics,” Tracy said.
Dr. Bacharier reported speaker fees and research support from Sanofi/Regeneron. Dr. Tracy has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Dupilumab (Dupixent, Sanofi and Regeneron) significantly reduced exacerbations compared with placebo in children ages 6-11 years who had moderate-to-severe asthma in a phase 3 trial.
A fully human monoclonal antibody, dupilumab also improved lung function versus placebo by week 12, an improvement that lasted the length of the 52-week trial.
Dupilumab previously had been shown to be safe and effective in adolescents and adults with moderate-to-severe asthma, patients 6 years and older with moderate-to-severe atopic dermatitis, and adults with chronic rhinosinusitis with nasal polyposis, but its safety and effectiveness for moderate-to-severe asthma in the 6-11 years age group was not known.
Results from the randomized, double-blind VOYAGE study conducted across several countries were presented Saturday, July 10, at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021.
Leonard B. Bacharier, MD, professor of pediatrics, allergy/immunology/pulmonary medicine at Vanderbilt University Medical Center in Nashville, Tennessee, presented the results from the trial, which was funded by Sanofi/Regeneron.
Researchers enrolled 408 children ages 6-11 years with uncontrolled moderate-to-severe asthma. Children on high-dose inhaled corticosteroids (ICS) alone or medium-to-high–dose ICS with a second controller were randomly assigned either to add-on subcutaneous dupilumab 100 mg or 200 mg, based on body weight at study start, or to placebo every 2 weeks for 52 weeks.
Analyses were done in two populations: 350 patients with markers of type 2 inflammation (baseline blood eosinophils ≥150 cells/μl or fractional exhaled nitric oxide [FeNO] ≥20 ppb) and 259 patients with baseline blood eosinophils ≥300 cells/µl.
“The primary endpoint was the annualized rate of severe asthma exacerbations,” Dr. Bacharier said. “The key secondary endpoint was change in percent predicted prebronchodilator FEV1 [forced expiratory volume at 1 second] from baseline to week 12.”
At week 12, the annualized severe asthma exacerbation rate was reduced by 59% (P < .0001) in children with blood eosinophils ≥300 cells/µL and results were similar in those with the type 2 inflammatory phenotype compared with placebo.
Results also indicate a favorable safety profile for dupilumab.
James M. Tracy, DO, an expert with the American College of Allergy, Asthma, and Immunology, told this news organization that adding the dupilumab option for children in the 6-11 age group is “huge.”
Dr. Tracy, who was not involved with the study, said although omalizumab (Xolair, Genentech) is also available for these children, dupilumab stands out because of the range of comorbidities it can treat.
“[Children] don’t have the same rhinosinusitis and polyposis that adults would have, but a lot of them have eczema, and this drug with multiple prongs is incredibly useful and addresses a broad array of allergic conditions,” Dr. Tracy said.
More than 90% of children in the study had at least one concurrent type 2 inflammatory condition, including atopic dermatitis and eosinophilic esophagitis. Dupilumab blocks the shared receptor for interleukin (IL)-4/IL-13, which are key drivers of type 2 inflammation in multiple diseases.
Dr. Tracy said that while dupilumab is not the only drug available to treat children 6-11 years with moderate-to-severe asthma, it is “a significant and unique addition to the armamentarium of the individual practitioner taking care of these very severe asthmatics in the 6-11 age group.”
Dupilumab also led to rapid and sustained improvement in lung function. At 12 weeks, children assigned dupilumab improved their lung function as measured by FEV1 by 5.21% (P = .0009), and that continued through the 52-week study period.
“What we know is the [improved lung function] effect is sustained. What we don’t know is how long you have to keep on the drug for a more permanent effect, which is an issue for all these biologics,” Tracy said.
Dr. Bacharier reported speaker fees and research support from Sanofi/Regeneron. Dr. Tracy has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Vaccine mandates, passports, and Kant
Houston Methodist Hospital in June 2021 enforced an April mandate that all its employees, about 26,000 of them, must be vaccinated against COVID-19. In the following weeks, many other large health care systems adopted a similar employer mandate.
Compliance with Houston Methodist’s mandate has been very high at nearly 99%. There were some deferrals, mostly because of pregnancy. There were some “medical and personal” exemptions for less than 1% of employees. The reasons for those personal exemptions have not been made public. A lawsuit by 117 employees objecting to the vaccine mandate was dismissed by a federal district judge on June 12.
Objections to the vaccine mandate have rarely involved religious-based conscientious objections, which need to be accommodated differently, legally and ethically. The objections have been disagreements on the science. As a politician said decades ago: “People are entitled to their own opinions, but not their own facts.” A medical institution is an excellent organization for determining the risks and benefits of vaccination. The judge dismissing the case was very critical of the characterizations used by the plaintiffs.
The vaccine mandate has strong ethical support from both the universalizability principle of Kant and a consequentialist analysis. The U.S. Equal Employment Opportunity Commission on May 28, 2021, released technical assistance that has generally been interpreted to support an employer’s right to set vaccine requirements. HIPAA does not forbid an employer from asking about vaccination, but the EEOC guidance reminds employers that if they do ask, employers have legal obligations to protect the health information and keep it separate from other personnel files.
In the past few years, many hospitals and clinics have adopted mandates for influenza vaccines. In many children’s hospitals staff have been required to have chicken pox vaccines (or, as in my case, titers showing immunity from the real thing – I’m old) since the early 2000s. Measles titers (again, mine were acquired naturally – I still remember the illness and recommend against that) and TB status are occasionally required for locum tenens positions. I keep copies of these labs alongside copies of my diplomas. To me, the COVID-19 mandate is not capricious.
Some people have pointed out that the COVID-19 vaccines are not fully Food and Drug Administration approved. They are used under an emergency use authorization. Any traction that distinction might have had ethically and scientifically in November 2020 has disappeared with the experience of 9 months and 300 million doses in the United States. Dr. Fauci on July 11, 2021, said: “These vaccines are as good as officially approved with all the I’s dotted and the T’s crossed.”
On July 12, 2021, French President Macron, facing a resurgence of the pandemic because of the delta variant, announced a national vaccine mandate for all health care workers. He also announced plans to require proof of vaccination (or prior disease) in order to enter amusement parks, restaurants, and other public facilities. The ethics of his plans have been debated by ethicists and politicians for months under the rubric of a “vaccine passport.” England has required proof of vaccination or a recent negative COVID-19 test before entering soccer stadiums. In the United States, some localities, particularly those where the local politicians are against the vaccine, have passed laws proscribing the creation of these passport-like restrictions. Elsewhere, many businesses have already started to exclude customers who are not vaccinated. Airlines, hotels, and cruise ships are at the forefront of this. Society has started to create consequences for not getting the vaccine. President Macron indicated that the goal was now to put restrictions on the unvaccinated rather than on everyone.
Pediatricians are experts on the importance of consequences for misbehavior and refusals. It is a frequent topic of conversation with parents of toddlers and teenagers. Consequences are ethical, just, and effective ways of promoting safe and fair behavior. At this point, the public has been educated about the disease and the vaccines. In the United States, there has been ample access to the vaccine. It is time to enforce consequences.
Daily vaccination rates in the United States have slowed to 25% of the peak rates. The reasons for hesitancy have been analyzed in many publications. Further public education hasn’t been productive, so empathic listening has been urged to overcome hesitancy. (A similar program has long been advocated to deal with hesitancy for teenage HPV vaccines.) President Biden on July 6, 2021, proposed a program of going door to door to overcome resistance.
The world is in a race between vaccines and the delta variant. The Delta variant is moving the finish line, with some French epidemiologists advising President Macron that this more contagious variant may require a 90% vaccination level to achieve herd immunity. Israel has started giving a third booster shot in select situations and Pfizer is considering the idea. I agree with providing education, using empathic listening, and improving access. Those are all reasonable, even necessary, strategies. But at this point, I anchor my suggestions with the same advice pediatricians have long given to parents. Set rules and create consequences for misbehavior.
Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no financial disclosures. Email him at [email protected].
Houston Methodist Hospital in June 2021 enforced an April mandate that all its employees, about 26,000 of them, must be vaccinated against COVID-19. In the following weeks, many other large health care systems adopted a similar employer mandate.
Compliance with Houston Methodist’s mandate has been very high at nearly 99%. There were some deferrals, mostly because of pregnancy. There were some “medical and personal” exemptions for less than 1% of employees. The reasons for those personal exemptions have not been made public. A lawsuit by 117 employees objecting to the vaccine mandate was dismissed by a federal district judge on June 12.
Objections to the vaccine mandate have rarely involved religious-based conscientious objections, which need to be accommodated differently, legally and ethically. The objections have been disagreements on the science. As a politician said decades ago: “People are entitled to their own opinions, but not their own facts.” A medical institution is an excellent organization for determining the risks and benefits of vaccination. The judge dismissing the case was very critical of the characterizations used by the plaintiffs.
The vaccine mandate has strong ethical support from both the universalizability principle of Kant and a consequentialist analysis. The U.S. Equal Employment Opportunity Commission on May 28, 2021, released technical assistance that has generally been interpreted to support an employer’s right to set vaccine requirements. HIPAA does not forbid an employer from asking about vaccination, but the EEOC guidance reminds employers that if they do ask, employers have legal obligations to protect the health information and keep it separate from other personnel files.
In the past few years, many hospitals and clinics have adopted mandates for influenza vaccines. In many children’s hospitals staff have been required to have chicken pox vaccines (or, as in my case, titers showing immunity from the real thing – I’m old) since the early 2000s. Measles titers (again, mine were acquired naturally – I still remember the illness and recommend against that) and TB status are occasionally required for locum tenens positions. I keep copies of these labs alongside copies of my diplomas. To me, the COVID-19 mandate is not capricious.
Some people have pointed out that the COVID-19 vaccines are not fully Food and Drug Administration approved. They are used under an emergency use authorization. Any traction that distinction might have had ethically and scientifically in November 2020 has disappeared with the experience of 9 months and 300 million doses in the United States. Dr. Fauci on July 11, 2021, said: “These vaccines are as good as officially approved with all the I’s dotted and the T’s crossed.”
On July 12, 2021, French President Macron, facing a resurgence of the pandemic because of the delta variant, announced a national vaccine mandate for all health care workers. He also announced plans to require proof of vaccination (or prior disease) in order to enter amusement parks, restaurants, and other public facilities. The ethics of his plans have been debated by ethicists and politicians for months under the rubric of a “vaccine passport.” England has required proof of vaccination or a recent negative COVID-19 test before entering soccer stadiums. In the United States, some localities, particularly those where the local politicians are against the vaccine, have passed laws proscribing the creation of these passport-like restrictions. Elsewhere, many businesses have already started to exclude customers who are not vaccinated. Airlines, hotels, and cruise ships are at the forefront of this. Society has started to create consequences for not getting the vaccine. President Macron indicated that the goal was now to put restrictions on the unvaccinated rather than on everyone.
Pediatricians are experts on the importance of consequences for misbehavior and refusals. It is a frequent topic of conversation with parents of toddlers and teenagers. Consequences are ethical, just, and effective ways of promoting safe and fair behavior. At this point, the public has been educated about the disease and the vaccines. In the United States, there has been ample access to the vaccine. It is time to enforce consequences.
Daily vaccination rates in the United States have slowed to 25% of the peak rates. The reasons for hesitancy have been analyzed in many publications. Further public education hasn’t been productive, so empathic listening has been urged to overcome hesitancy. (A similar program has long been advocated to deal with hesitancy for teenage HPV vaccines.) President Biden on July 6, 2021, proposed a program of going door to door to overcome resistance.
The world is in a race between vaccines and the delta variant. The Delta variant is moving the finish line, with some French epidemiologists advising President Macron that this more contagious variant may require a 90% vaccination level to achieve herd immunity. Israel has started giving a third booster shot in select situations and Pfizer is considering the idea. I agree with providing education, using empathic listening, and improving access. Those are all reasonable, even necessary, strategies. But at this point, I anchor my suggestions with the same advice pediatricians have long given to parents. Set rules and create consequences for misbehavior.
Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no financial disclosures. Email him at [email protected].
Houston Methodist Hospital in June 2021 enforced an April mandate that all its employees, about 26,000 of them, must be vaccinated against COVID-19. In the following weeks, many other large health care systems adopted a similar employer mandate.
Compliance with Houston Methodist’s mandate has been very high at nearly 99%. There were some deferrals, mostly because of pregnancy. There were some “medical and personal” exemptions for less than 1% of employees. The reasons for those personal exemptions have not been made public. A lawsuit by 117 employees objecting to the vaccine mandate was dismissed by a federal district judge on June 12.
Objections to the vaccine mandate have rarely involved religious-based conscientious objections, which need to be accommodated differently, legally and ethically. The objections have been disagreements on the science. As a politician said decades ago: “People are entitled to their own opinions, but not their own facts.” A medical institution is an excellent organization for determining the risks and benefits of vaccination. The judge dismissing the case was very critical of the characterizations used by the plaintiffs.
The vaccine mandate has strong ethical support from both the universalizability principle of Kant and a consequentialist analysis. The U.S. Equal Employment Opportunity Commission on May 28, 2021, released technical assistance that has generally been interpreted to support an employer’s right to set vaccine requirements. HIPAA does not forbid an employer from asking about vaccination, but the EEOC guidance reminds employers that if they do ask, employers have legal obligations to protect the health information and keep it separate from other personnel files.
In the past few years, many hospitals and clinics have adopted mandates for influenza vaccines. In many children’s hospitals staff have been required to have chicken pox vaccines (or, as in my case, titers showing immunity from the real thing – I’m old) since the early 2000s. Measles titers (again, mine were acquired naturally – I still remember the illness and recommend against that) and TB status are occasionally required for locum tenens positions. I keep copies of these labs alongside copies of my diplomas. To me, the COVID-19 mandate is not capricious.
Some people have pointed out that the COVID-19 vaccines are not fully Food and Drug Administration approved. They are used under an emergency use authorization. Any traction that distinction might have had ethically and scientifically in November 2020 has disappeared with the experience of 9 months and 300 million doses in the United States. Dr. Fauci on July 11, 2021, said: “These vaccines are as good as officially approved with all the I’s dotted and the T’s crossed.”
On July 12, 2021, French President Macron, facing a resurgence of the pandemic because of the delta variant, announced a national vaccine mandate for all health care workers. He also announced plans to require proof of vaccination (or prior disease) in order to enter amusement parks, restaurants, and other public facilities. The ethics of his plans have been debated by ethicists and politicians for months under the rubric of a “vaccine passport.” England has required proof of vaccination or a recent negative COVID-19 test before entering soccer stadiums. In the United States, some localities, particularly those where the local politicians are against the vaccine, have passed laws proscribing the creation of these passport-like restrictions. Elsewhere, many businesses have already started to exclude customers who are not vaccinated. Airlines, hotels, and cruise ships are at the forefront of this. Society has started to create consequences for not getting the vaccine. President Macron indicated that the goal was now to put restrictions on the unvaccinated rather than on everyone.
Pediatricians are experts on the importance of consequences for misbehavior and refusals. It is a frequent topic of conversation with parents of toddlers and teenagers. Consequences are ethical, just, and effective ways of promoting safe and fair behavior. At this point, the public has been educated about the disease and the vaccines. In the United States, there has been ample access to the vaccine. It is time to enforce consequences.
Daily vaccination rates in the United States have slowed to 25% of the peak rates. The reasons for hesitancy have been analyzed in many publications. Further public education hasn’t been productive, so empathic listening has been urged to overcome hesitancy. (A similar program has long been advocated to deal with hesitancy for teenage HPV vaccines.) President Biden on July 6, 2021, proposed a program of going door to door to overcome resistance.
The world is in a race between vaccines and the delta variant. The Delta variant is moving the finish line, with some French epidemiologists advising President Macron that this more contagious variant may require a 90% vaccination level to achieve herd immunity. Israel has started giving a third booster shot in select situations and Pfizer is considering the idea. I agree with providing education, using empathic listening, and improving access. Those are all reasonable, even necessary, strategies. But at this point, I anchor my suggestions with the same advice pediatricians have long given to parents. Set rules and create consequences for misbehavior.
Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no financial disclosures. Email him at [email protected].
Dogs know their humans, but humans don’t know expiration dates
An extreme price to pay for immortality
We know that men don’t live as long as women, but the reasons aren’t entirely clear. However, some New Zealand scientists have a thought on the subject, thanks to a sheep called Shrek.
The researchers were inspired by a famous old sheep who escaped captivity, but was captured 6 years later at the age of 10. The sheep then lived 6 more years, far beyond the lifespan of a normal sheep, capturing the hearts and minds of Kiwis everywhere. Look, it’s New Zealand, sheep are life, so it’s only natural the country got attached. Scientists from the University of Otago suspected that Shrek lived such a long life because he was castrated.
So they undertook a study of sheep, and lo and behold, sheep that were castrated lived significantly longer than their uncastrated kin, thanks to a slowing of their epigenetic clocks – the DNA aged noticeably slower in the castrated sheep.
Although the research can most immediately be applied to the improvement of the New Zealand sheep industry, the implication for humanity is also apparent. Want to live longer? Get rid of the testosterone. An extreme solution to be sure. As previously reported in this column, researchers wanted to torture our mouths to get us to lose weight, and now they want to castrate people for longer life. What exactly is going on down there in New Zealand?
Man’s best mind reader
There are a lot of reasons why dogs are sometimes called “man’s best friend,” but the root of it may actually have something to do with how easily we communicate with each other. Researchers dug deeper and fetched something that Fido is born with, but his wild wolf cousin isn’t.
That something is known as the “theory of mind” ability. Have you noticed that when you point and tell dogs to grab a leash or toy, they react as if they understood the language you spoke? Researchers from Duke University wondered if this ability is a canine thing or just a domesticated dog thing.
They compared 44 canine puppies and 37 wolf pups between 5 and 18 weeks old. The wolf pups were taken into human homes and raised with a great amount of human interaction, while the dog pups were left with their mothers and raised with less human interaction.
All the puppies were then put through multiple tests. In one test, they were given clues to find a treat under a bowl. In another test, a block of wood was placed next to the treat as a physical marker. During yet another test, researchers pointed to the food directly.
The researchers discovered that the dog puppies knew where the treat was every time, while their wild relatives didn’t.
“This study really solidifies the evidence that the social genius of dogs is a product of domestication,” senior author Brian Hare said in a separate statement.
The domestication hypothesis theorizes that dogs picked up the human social cues through thousands of years of interaction. The more friendly and cooperative a wolf was with humans, the more likely it was to survive and pass on those same traits and practices. Even within the study, the dog puppies were 30 times more likely to approach a stranger than were the wolf pups.
You may think your dog understands everything you say, but it’s actually body language that Fido is most fluent in.
I’m not a dentist, but I play one on TikTok
In last week’s column, it was garlic cloves up the nose to treat a cold. This week, TikTok brings us a new way to whiten teeth.
Familiar with the Mr. Clean Magic Eraser? If not, we’ll save you the trouble of Googling it: Check it out here and here.
Have you heard anything about using it to clean your teeth? No, neither did we, and we did a lot of Googling. Proctor & Gamble, which makes the Magic Eraser, goes so far as to say on the package: “Do not use on skin or other parts of the body. Using on skin will likely cause abrasions.” (The warning is actually in all caps, but we are stylistically forbidden by our editorial overlords to do that.)
But it’s magic, right? How can you not use it on your teeth? Enter TikTok. Heather Dunn posted a video in which she rubbed a bit of a Magic Eraser on her teeth – being careful to avoid her gums, because you can never be too careful – “as the product squeaked back and forth,” the Miami Herald reported. The video has almost 256,000 likes so far.
“Yeah, your teeth are white because you scrubbed all the enamel off them. So don’t do this,” Dr. Benjamin Winters, aka the Bentist, said in a YouTube video that has 105,000 likes.
In this race for common sense, common sense is losing. Please help the Bentist restore sanity to the dental world by liking his video. It would make Mr. Clean happy.
Don’t let an expiration date boss you around
Surely you’ve been there: It’s Taco Tuesday and you’re rummaging through the refrigerator to find that shredded cheese you’re sure you have. Jackpot! You find it, but realize it’s probably been in the refrigerator for a while. You open the bag, it smells and looks fine, but the expiration date was 2 days ago. Now you have a decision to make. Maybe you’ll be fine, or maybe you’ll risk food poisoning right before your brother’s wedding.
But here’s the truth: Americans throw away perfectly good food every day. The average American family throws out $1,365 to $2,275 worth of food a year, according to a 2013 study.
Truthfully, expiration dates are not for buyers, rather they’re for stores to have an idea of their stock’s freshness. Emily Broad Leib, director of the Harvard Law School Food and Policy Clinic and lead author of the 2013 study, told Vox that manufacturers use the dates as a way of “protecting the brand” to keep consumers from eating food that’s just a little past its peak.
With approximately 40 million people in the United States concerned about where their next meal is coming from, the Vox article noted, we need to reevaluate our system. Our national misunderstanding of expiration labels is hurting both suppliers and consumers because perfectly good food is wasted.
Sure, there is always that chance that something might be a little funky after a certain amount of time, but all in all, food probably stays fresh a lot longer than we think. Don’t always judge the shredded cheese by its expiration date.
An extreme price to pay for immortality
We know that men don’t live as long as women, but the reasons aren’t entirely clear. However, some New Zealand scientists have a thought on the subject, thanks to a sheep called Shrek.
The researchers were inspired by a famous old sheep who escaped captivity, but was captured 6 years later at the age of 10. The sheep then lived 6 more years, far beyond the lifespan of a normal sheep, capturing the hearts and minds of Kiwis everywhere. Look, it’s New Zealand, sheep are life, so it’s only natural the country got attached. Scientists from the University of Otago suspected that Shrek lived such a long life because he was castrated.
So they undertook a study of sheep, and lo and behold, sheep that were castrated lived significantly longer than their uncastrated kin, thanks to a slowing of their epigenetic clocks – the DNA aged noticeably slower in the castrated sheep.
Although the research can most immediately be applied to the improvement of the New Zealand sheep industry, the implication for humanity is also apparent. Want to live longer? Get rid of the testosterone. An extreme solution to be sure. As previously reported in this column, researchers wanted to torture our mouths to get us to lose weight, and now they want to castrate people for longer life. What exactly is going on down there in New Zealand?
Man’s best mind reader
There are a lot of reasons why dogs are sometimes called “man’s best friend,” but the root of it may actually have something to do with how easily we communicate with each other. Researchers dug deeper and fetched something that Fido is born with, but his wild wolf cousin isn’t.
That something is known as the “theory of mind” ability. Have you noticed that when you point and tell dogs to grab a leash or toy, they react as if they understood the language you spoke? Researchers from Duke University wondered if this ability is a canine thing or just a domesticated dog thing.
They compared 44 canine puppies and 37 wolf pups between 5 and 18 weeks old. The wolf pups were taken into human homes and raised with a great amount of human interaction, while the dog pups were left with their mothers and raised with less human interaction.
All the puppies were then put through multiple tests. In one test, they were given clues to find a treat under a bowl. In another test, a block of wood was placed next to the treat as a physical marker. During yet another test, researchers pointed to the food directly.
The researchers discovered that the dog puppies knew where the treat was every time, while their wild relatives didn’t.
“This study really solidifies the evidence that the social genius of dogs is a product of domestication,” senior author Brian Hare said in a separate statement.
The domestication hypothesis theorizes that dogs picked up the human social cues through thousands of years of interaction. The more friendly and cooperative a wolf was with humans, the more likely it was to survive and pass on those same traits and practices. Even within the study, the dog puppies were 30 times more likely to approach a stranger than were the wolf pups.
You may think your dog understands everything you say, but it’s actually body language that Fido is most fluent in.
I’m not a dentist, but I play one on TikTok
In last week’s column, it was garlic cloves up the nose to treat a cold. This week, TikTok brings us a new way to whiten teeth.
Familiar with the Mr. Clean Magic Eraser? If not, we’ll save you the trouble of Googling it: Check it out here and here.
Have you heard anything about using it to clean your teeth? No, neither did we, and we did a lot of Googling. Proctor & Gamble, which makes the Magic Eraser, goes so far as to say on the package: “Do not use on skin or other parts of the body. Using on skin will likely cause abrasions.” (The warning is actually in all caps, but we are stylistically forbidden by our editorial overlords to do that.)
But it’s magic, right? How can you not use it on your teeth? Enter TikTok. Heather Dunn posted a video in which she rubbed a bit of a Magic Eraser on her teeth – being careful to avoid her gums, because you can never be too careful – “as the product squeaked back and forth,” the Miami Herald reported. The video has almost 256,000 likes so far.
“Yeah, your teeth are white because you scrubbed all the enamel off them. So don’t do this,” Dr. Benjamin Winters, aka the Bentist, said in a YouTube video that has 105,000 likes.
In this race for common sense, common sense is losing. Please help the Bentist restore sanity to the dental world by liking his video. It would make Mr. Clean happy.
Don’t let an expiration date boss you around
Surely you’ve been there: It’s Taco Tuesday and you’re rummaging through the refrigerator to find that shredded cheese you’re sure you have. Jackpot! You find it, but realize it’s probably been in the refrigerator for a while. You open the bag, it smells and looks fine, but the expiration date was 2 days ago. Now you have a decision to make. Maybe you’ll be fine, or maybe you’ll risk food poisoning right before your brother’s wedding.
But here’s the truth: Americans throw away perfectly good food every day. The average American family throws out $1,365 to $2,275 worth of food a year, according to a 2013 study.
Truthfully, expiration dates are not for buyers, rather they’re for stores to have an idea of their stock’s freshness. Emily Broad Leib, director of the Harvard Law School Food and Policy Clinic and lead author of the 2013 study, told Vox that manufacturers use the dates as a way of “protecting the brand” to keep consumers from eating food that’s just a little past its peak.
With approximately 40 million people in the United States concerned about where their next meal is coming from, the Vox article noted, we need to reevaluate our system. Our national misunderstanding of expiration labels is hurting both suppliers and consumers because perfectly good food is wasted.
Sure, there is always that chance that something might be a little funky after a certain amount of time, but all in all, food probably stays fresh a lot longer than we think. Don’t always judge the shredded cheese by its expiration date.
An extreme price to pay for immortality
We know that men don’t live as long as women, but the reasons aren’t entirely clear. However, some New Zealand scientists have a thought on the subject, thanks to a sheep called Shrek.
The researchers were inspired by a famous old sheep who escaped captivity, but was captured 6 years later at the age of 10. The sheep then lived 6 more years, far beyond the lifespan of a normal sheep, capturing the hearts and minds of Kiwis everywhere. Look, it’s New Zealand, sheep are life, so it’s only natural the country got attached. Scientists from the University of Otago suspected that Shrek lived such a long life because he was castrated.
So they undertook a study of sheep, and lo and behold, sheep that were castrated lived significantly longer than their uncastrated kin, thanks to a slowing of their epigenetic clocks – the DNA aged noticeably slower in the castrated sheep.
Although the research can most immediately be applied to the improvement of the New Zealand sheep industry, the implication for humanity is also apparent. Want to live longer? Get rid of the testosterone. An extreme solution to be sure. As previously reported in this column, researchers wanted to torture our mouths to get us to lose weight, and now they want to castrate people for longer life. What exactly is going on down there in New Zealand?
Man’s best mind reader
There are a lot of reasons why dogs are sometimes called “man’s best friend,” but the root of it may actually have something to do with how easily we communicate with each other. Researchers dug deeper and fetched something that Fido is born with, but his wild wolf cousin isn’t.
That something is known as the “theory of mind” ability. Have you noticed that when you point and tell dogs to grab a leash or toy, they react as if they understood the language you spoke? Researchers from Duke University wondered if this ability is a canine thing or just a domesticated dog thing.
They compared 44 canine puppies and 37 wolf pups between 5 and 18 weeks old. The wolf pups were taken into human homes and raised with a great amount of human interaction, while the dog pups were left with their mothers and raised with less human interaction.
All the puppies were then put through multiple tests. In one test, they were given clues to find a treat under a bowl. In another test, a block of wood was placed next to the treat as a physical marker. During yet another test, researchers pointed to the food directly.
The researchers discovered that the dog puppies knew where the treat was every time, while their wild relatives didn’t.
“This study really solidifies the evidence that the social genius of dogs is a product of domestication,” senior author Brian Hare said in a separate statement.
The domestication hypothesis theorizes that dogs picked up the human social cues through thousands of years of interaction. The more friendly and cooperative a wolf was with humans, the more likely it was to survive and pass on those same traits and practices. Even within the study, the dog puppies were 30 times more likely to approach a stranger than were the wolf pups.
You may think your dog understands everything you say, but it’s actually body language that Fido is most fluent in.
I’m not a dentist, but I play one on TikTok
In last week’s column, it was garlic cloves up the nose to treat a cold. This week, TikTok brings us a new way to whiten teeth.
Familiar with the Mr. Clean Magic Eraser? If not, we’ll save you the trouble of Googling it: Check it out here and here.
Have you heard anything about using it to clean your teeth? No, neither did we, and we did a lot of Googling. Proctor & Gamble, which makes the Magic Eraser, goes so far as to say on the package: “Do not use on skin or other parts of the body. Using on skin will likely cause abrasions.” (The warning is actually in all caps, but we are stylistically forbidden by our editorial overlords to do that.)
But it’s magic, right? How can you not use it on your teeth? Enter TikTok. Heather Dunn posted a video in which she rubbed a bit of a Magic Eraser on her teeth – being careful to avoid her gums, because you can never be too careful – “as the product squeaked back and forth,” the Miami Herald reported. The video has almost 256,000 likes so far.
“Yeah, your teeth are white because you scrubbed all the enamel off them. So don’t do this,” Dr. Benjamin Winters, aka the Bentist, said in a YouTube video that has 105,000 likes.
In this race for common sense, common sense is losing. Please help the Bentist restore sanity to the dental world by liking his video. It would make Mr. Clean happy.
Don’t let an expiration date boss you around
Surely you’ve been there: It’s Taco Tuesday and you’re rummaging through the refrigerator to find that shredded cheese you’re sure you have. Jackpot! You find it, but realize it’s probably been in the refrigerator for a while. You open the bag, it smells and looks fine, but the expiration date was 2 days ago. Now you have a decision to make. Maybe you’ll be fine, or maybe you’ll risk food poisoning right before your brother’s wedding.
But here’s the truth: Americans throw away perfectly good food every day. The average American family throws out $1,365 to $2,275 worth of food a year, according to a 2013 study.
Truthfully, expiration dates are not for buyers, rather they’re for stores to have an idea of their stock’s freshness. Emily Broad Leib, director of the Harvard Law School Food and Policy Clinic and lead author of the 2013 study, told Vox that manufacturers use the dates as a way of “protecting the brand” to keep consumers from eating food that’s just a little past its peak.
With approximately 40 million people in the United States concerned about where their next meal is coming from, the Vox article noted, we need to reevaluate our system. Our national misunderstanding of expiration labels is hurting both suppliers and consumers because perfectly good food is wasted.
Sure, there is always that chance that something might be a little funky after a certain amount of time, but all in all, food probably stays fresh a lot longer than we think. Don’t always judge the shredded cheese by its expiration date.
Pediatric alopecia areata in the U.S. has increased twofold since 2009, study finds
according to results from the largest study to date on the topic.
“Alopecia areata is a relatively common cause of nonscarring hair loss in children,” Paige McKenzie said during the annual meeting of the Society for Pediatric Dermatology. “The only two epidemiologic studies that have been performed in children have been based on registry or survey data which is inherently at risk for bias,” she added, referring to studies published in 2017 and 2018. “Additionally, epidemiologic descriptions of alopecia areata in adults are limited and overall estimates have varied from 0.2% to 2%. Current understanding is also largely based on population studies in Olmsted County, Minnesota, an area with mostly White racial demographics, so it’s not representative of the U.S. population as a whole.”
To identify the incidence and prevalence of pediatric AA over time, and across age, race/ethnicity, and sex, Ms. McKenzie and colleagues conducted a retrospective cohort study from 2009 to 2020 using PEDSnet, a network of seven U.S. pediatric health institutions with a database of more than 6.5 million children. “PEDSnet is unique because it uses a common data model to standardize EHR data across different health systems and uses SNOMED [Systematized Nomenclature of Medicine]–Clinical Terms to identify specific patient populations,” said Ms. McKenzie, who was a clinical research fellow in the section of dermatology at the Children’s Hospital of Philadelphia during the 2020-2021 academic year.
She and her coauthors limited their analysis to children younger than age 18 who were assigned a SNOMED code for AA during at least one dermatology physician visit or at least two nondermatology physician visits. They also identified an incidence cohort that was a subset of the study cohort who had at least 12 months of follow-up. “To determine the accuracy of AA patient identification, we also reviewed 100 cases at random from one institution with a threshold of greater than 95% accuracy,” said Ms. McKenzie, who is now a fourth-year medical student at the University of Texas Southwestern Medical Center, Dallas.
Of 5,409,919 children included in the study, 5,801 had AA, for an overall prevalence of 0.11%. The prevalence doubled from 0.04% in 2009 to 0.08% in 2019. “It fell in 2020, which we believe is a result of the COVID-19 pandemic’s effects on health care utilization,” she said. AA prevalence peaked at 9 years of age and was higher among females, compared with males (0.12% vs. 0.09%, respectively). The prevalence was highest among Hispanic children (0.23%), followed by Asian children (0.17%), Black children (0.12%), and White children (0.08%).
The incidence cohort consisted of 2,896,241 children. Of these, 2,398 had AA between 2009-2020, for an overall incidence of 13.6 cases per 100,000 patient-years. The incidence rate of AA by age was normally distributed and peaked at 6 years of age. Rates were 22.8% higher in female patients than in male patients. In addition, incidence rates were highest among Hispanics (31.5/100,000 person-years), followed by Asians (23.1/100,000 person-years), Blacks (17.0/100,000 person-years), and Whites (8.8/100,000).
Logistic regression analysis showed general agreement with the unadjusted incidence data. Males were less likely to be diagnosed with AA, compared with females (adjusted odds ratio, 0.80; P < .001). Analysis across race/ethnicity revealed significantly increased rates among children from minority backgrounds when compared with white children. Hispanic children had the greatest risk of developing AA (aOR, 3.07), followed by Asian children (aOR, 2.02), and Black children (aOR, 1.73) (P < .001 for all associations). Patients with atopic dermatitis, thyroid disease, psoriasis, vitiligo, and trisomy 21 prior to AA diagnosis all had a significantly higher risk of developing AA, compared with those without those diagnoses.
“This is the largest description of pediatric AA to date,” Ms. McKenzie said. “The prevalence has increased steadily, with a twofold increase over the last 10 years, which mirrors other autoimmune disorders. Children who identify as Hispanic, Asian, and Black have significantly higher incidence rates of alopecia areata compared to those who identify as White.”
Moving forward, she added, “efforts should focus on increasing education and awareness of AA in diverse communities and in community pediatricians so that patients can be diagnosed correctly early on. We can also use this data to ensure that representative populations are included in clinical trials for patients with AA.”
Asked to comment on the results Maria Hordinsky, MD, professor and chair of the department of dermatology at the University of Minnesota, Minneapolis, said that the study “is a great contribution to our understanding of the epidemiology of pediatric alopecia areata and also highlights how common alopecia areata is in children.” In an interview, she said that it would be interesting to see if this is a worldwide phenomenon or unique to the United States.
Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study, characterized the work as being “very informative. Looking at a large cohort of pediatric patients with alopecia areata diagnosed by a dermatologist or two or more nondermatologists, the authors found a higher incidence and prevalence in nonwhite children here in the United States. I am worried in fact, the true incidence could be even higher than noted in the searched database because nonwhite children can often come from underserved and undercared for areas.”
The other authors were Christopher B. Forrest, MD, PhD, Mitchell Maltenfort, PhD, and Leslie Castelo-Soccio, MD, PhD, of Children’s Hospital of Philadelphia. Dr. Castelo-Soccio is a consultant for Pfizer; the other authors reported having no financial disclosures. Dr. Hordinsky disclosed receiving grant support for clinical research work on hair diseases from Pfizer, Eli Lilly, Concert Pharmaceuticals, and Target Derm and grant support from the National Alopecia Areata Foundation; and is on an advisory panel for Cassiopea. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
*This story was updated on 7/19/21.
according to results from the largest study to date on the topic.
“Alopecia areata is a relatively common cause of nonscarring hair loss in children,” Paige McKenzie said during the annual meeting of the Society for Pediatric Dermatology. “The only two epidemiologic studies that have been performed in children have been based on registry or survey data which is inherently at risk for bias,” she added, referring to studies published in 2017 and 2018. “Additionally, epidemiologic descriptions of alopecia areata in adults are limited and overall estimates have varied from 0.2% to 2%. Current understanding is also largely based on population studies in Olmsted County, Minnesota, an area with mostly White racial demographics, so it’s not representative of the U.S. population as a whole.”
To identify the incidence and prevalence of pediatric AA over time, and across age, race/ethnicity, and sex, Ms. McKenzie and colleagues conducted a retrospective cohort study from 2009 to 2020 using PEDSnet, a network of seven U.S. pediatric health institutions with a database of more than 6.5 million children. “PEDSnet is unique because it uses a common data model to standardize EHR data across different health systems and uses SNOMED [Systematized Nomenclature of Medicine]–Clinical Terms to identify specific patient populations,” said Ms. McKenzie, who was a clinical research fellow in the section of dermatology at the Children’s Hospital of Philadelphia during the 2020-2021 academic year.
She and her coauthors limited their analysis to children younger than age 18 who were assigned a SNOMED code for AA during at least one dermatology physician visit or at least two nondermatology physician visits. They also identified an incidence cohort that was a subset of the study cohort who had at least 12 months of follow-up. “To determine the accuracy of AA patient identification, we also reviewed 100 cases at random from one institution with a threshold of greater than 95% accuracy,” said Ms. McKenzie, who is now a fourth-year medical student at the University of Texas Southwestern Medical Center, Dallas.
Of 5,409,919 children included in the study, 5,801 had AA, for an overall prevalence of 0.11%. The prevalence doubled from 0.04% in 2009 to 0.08% in 2019. “It fell in 2020, which we believe is a result of the COVID-19 pandemic’s effects on health care utilization,” she said. AA prevalence peaked at 9 years of age and was higher among females, compared with males (0.12% vs. 0.09%, respectively). The prevalence was highest among Hispanic children (0.23%), followed by Asian children (0.17%), Black children (0.12%), and White children (0.08%).
The incidence cohort consisted of 2,896,241 children. Of these, 2,398 had AA between 2009-2020, for an overall incidence of 13.6 cases per 100,000 patient-years. The incidence rate of AA by age was normally distributed and peaked at 6 years of age. Rates were 22.8% higher in female patients than in male patients. In addition, incidence rates were highest among Hispanics (31.5/100,000 person-years), followed by Asians (23.1/100,000 person-years), Blacks (17.0/100,000 person-years), and Whites (8.8/100,000).
Logistic regression analysis showed general agreement with the unadjusted incidence data. Males were less likely to be diagnosed with AA, compared with females (adjusted odds ratio, 0.80; P < .001). Analysis across race/ethnicity revealed significantly increased rates among children from minority backgrounds when compared with white children. Hispanic children had the greatest risk of developing AA (aOR, 3.07), followed by Asian children (aOR, 2.02), and Black children (aOR, 1.73) (P < .001 for all associations). Patients with atopic dermatitis, thyroid disease, psoriasis, vitiligo, and trisomy 21 prior to AA diagnosis all had a significantly higher risk of developing AA, compared with those without those diagnoses.
“This is the largest description of pediatric AA to date,” Ms. McKenzie said. “The prevalence has increased steadily, with a twofold increase over the last 10 years, which mirrors other autoimmune disorders. Children who identify as Hispanic, Asian, and Black have significantly higher incidence rates of alopecia areata compared to those who identify as White.”
Moving forward, she added, “efforts should focus on increasing education and awareness of AA in diverse communities and in community pediatricians so that patients can be diagnosed correctly early on. We can also use this data to ensure that representative populations are included in clinical trials for patients with AA.”
Asked to comment on the results Maria Hordinsky, MD, professor and chair of the department of dermatology at the University of Minnesota, Minneapolis, said that the study “is a great contribution to our understanding of the epidemiology of pediatric alopecia areata and also highlights how common alopecia areata is in children.” In an interview, she said that it would be interesting to see if this is a worldwide phenomenon or unique to the United States.
Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study, characterized the work as being “very informative. Looking at a large cohort of pediatric patients with alopecia areata diagnosed by a dermatologist or two or more nondermatologists, the authors found a higher incidence and prevalence in nonwhite children here in the United States. I am worried in fact, the true incidence could be even higher than noted in the searched database because nonwhite children can often come from underserved and undercared for areas.”
The other authors were Christopher B. Forrest, MD, PhD, Mitchell Maltenfort, PhD, and Leslie Castelo-Soccio, MD, PhD, of Children’s Hospital of Philadelphia. Dr. Castelo-Soccio is a consultant for Pfizer; the other authors reported having no financial disclosures. Dr. Hordinsky disclosed receiving grant support for clinical research work on hair diseases from Pfizer, Eli Lilly, Concert Pharmaceuticals, and Target Derm and grant support from the National Alopecia Areata Foundation; and is on an advisory panel for Cassiopea. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
*This story was updated on 7/19/21.
according to results from the largest study to date on the topic.
“Alopecia areata is a relatively common cause of nonscarring hair loss in children,” Paige McKenzie said during the annual meeting of the Society for Pediatric Dermatology. “The only two epidemiologic studies that have been performed in children have been based on registry or survey data which is inherently at risk for bias,” she added, referring to studies published in 2017 and 2018. “Additionally, epidemiologic descriptions of alopecia areata in adults are limited and overall estimates have varied from 0.2% to 2%. Current understanding is also largely based on population studies in Olmsted County, Minnesota, an area with mostly White racial demographics, so it’s not representative of the U.S. population as a whole.”
To identify the incidence and prevalence of pediatric AA over time, and across age, race/ethnicity, and sex, Ms. McKenzie and colleagues conducted a retrospective cohort study from 2009 to 2020 using PEDSnet, a network of seven U.S. pediatric health institutions with a database of more than 6.5 million children. “PEDSnet is unique because it uses a common data model to standardize EHR data across different health systems and uses SNOMED [Systematized Nomenclature of Medicine]–Clinical Terms to identify specific patient populations,” said Ms. McKenzie, who was a clinical research fellow in the section of dermatology at the Children’s Hospital of Philadelphia during the 2020-2021 academic year.
She and her coauthors limited their analysis to children younger than age 18 who were assigned a SNOMED code for AA during at least one dermatology physician visit or at least two nondermatology physician visits. They also identified an incidence cohort that was a subset of the study cohort who had at least 12 months of follow-up. “To determine the accuracy of AA patient identification, we also reviewed 100 cases at random from one institution with a threshold of greater than 95% accuracy,” said Ms. McKenzie, who is now a fourth-year medical student at the University of Texas Southwestern Medical Center, Dallas.
Of 5,409,919 children included in the study, 5,801 had AA, for an overall prevalence of 0.11%. The prevalence doubled from 0.04% in 2009 to 0.08% in 2019. “It fell in 2020, which we believe is a result of the COVID-19 pandemic’s effects on health care utilization,” she said. AA prevalence peaked at 9 years of age and was higher among females, compared with males (0.12% vs. 0.09%, respectively). The prevalence was highest among Hispanic children (0.23%), followed by Asian children (0.17%), Black children (0.12%), and White children (0.08%).
The incidence cohort consisted of 2,896,241 children. Of these, 2,398 had AA between 2009-2020, for an overall incidence of 13.6 cases per 100,000 patient-years. The incidence rate of AA by age was normally distributed and peaked at 6 years of age. Rates were 22.8% higher in female patients than in male patients. In addition, incidence rates were highest among Hispanics (31.5/100,000 person-years), followed by Asians (23.1/100,000 person-years), Blacks (17.0/100,000 person-years), and Whites (8.8/100,000).
Logistic regression analysis showed general agreement with the unadjusted incidence data. Males were less likely to be diagnosed with AA, compared with females (adjusted odds ratio, 0.80; P < .001). Analysis across race/ethnicity revealed significantly increased rates among children from minority backgrounds when compared with white children. Hispanic children had the greatest risk of developing AA (aOR, 3.07), followed by Asian children (aOR, 2.02), and Black children (aOR, 1.73) (P < .001 for all associations). Patients with atopic dermatitis, thyroid disease, psoriasis, vitiligo, and trisomy 21 prior to AA diagnosis all had a significantly higher risk of developing AA, compared with those without those diagnoses.
“This is the largest description of pediatric AA to date,” Ms. McKenzie said. “The prevalence has increased steadily, with a twofold increase over the last 10 years, which mirrors other autoimmune disorders. Children who identify as Hispanic, Asian, and Black have significantly higher incidence rates of alopecia areata compared to those who identify as White.”
Moving forward, she added, “efforts should focus on increasing education and awareness of AA in diverse communities and in community pediatricians so that patients can be diagnosed correctly early on. We can also use this data to ensure that representative populations are included in clinical trials for patients with AA.”
Asked to comment on the results Maria Hordinsky, MD, professor and chair of the department of dermatology at the University of Minnesota, Minneapolis, said that the study “is a great contribution to our understanding of the epidemiology of pediatric alopecia areata and also highlights how common alopecia areata is in children.” In an interview, she said that it would be interesting to see if this is a worldwide phenomenon or unique to the United States.
Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study, characterized the work as being “very informative. Looking at a large cohort of pediatric patients with alopecia areata diagnosed by a dermatologist or two or more nondermatologists, the authors found a higher incidence and prevalence in nonwhite children here in the United States. I am worried in fact, the true incidence could be even higher than noted in the searched database because nonwhite children can often come from underserved and undercared for areas.”
The other authors were Christopher B. Forrest, MD, PhD, Mitchell Maltenfort, PhD, and Leslie Castelo-Soccio, MD, PhD, of Children’s Hospital of Philadelphia. Dr. Castelo-Soccio is a consultant for Pfizer; the other authors reported having no financial disclosures. Dr. Hordinsky disclosed receiving grant support for clinical research work on hair diseases from Pfizer, Eli Lilly, Concert Pharmaceuticals, and Target Derm and grant support from the National Alopecia Areata Foundation; and is on an advisory panel for Cassiopea. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
*This story was updated on 7/19/21.
FROM SPD 2021
Denial or a call to action?
Now that everyone in my family has been vaccinated, we’re starting to do more.
Last week we met my mom and some of her (vaccinated) friends for dinner at a local restaurant. Except for picking up takeout, I hadn’t been to one since early March 2020.
During the usual chatting about jobs, music, my kids, and trips we were thinking about, one of her friends suddenly said: “That’s funny.”
I asked him what was funny, and he said: “My left vision suddenly went dark.”
It only takes a fraction of a second to shift into doctor mode. I asked a few pointed questions and did a quick neuroscan for asymmetries, slurred speech, the things that, after 23 years, have become second nature.
It resolved after about 30 seconds. He clearly didn’t think it was anything to be alarmed about. He’s intelligent and well educated, but not a doctor. I wasn’t going to let it go, and quietly spoke to him a short while later. He may not be my patient, but pushing him in the needed direction is the right thing to do.
I’ve gotten him to the right doctors now, and the ball is rolling, but I keep thinking about it. If I hadn’t been there it’s likely nothing would have been done. In fact, he seemed to think it was more amusing than potentially serious.
Medical blogs and doctors’ lounge stories are full of similar anecdotes, where we wonder why people don’t take such things seriously. We tend to view such people as stupid and/or ignorant.
Yet, this gentleman is neither. I’ve known him since childhood. He’s smart, well educated, and well read. He’s not a medical person, though.
In reality, I don’t think doctors or nurses are any better. I suspect that’s more human nature, which is hard to override regardless of training.
But maybe it’s time to start giving these people, like my family friend, a pass, with the realization that denial and different training are part of being human, and not something to be poked fun at.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Now that everyone in my family has been vaccinated, we’re starting to do more.
Last week we met my mom and some of her (vaccinated) friends for dinner at a local restaurant. Except for picking up takeout, I hadn’t been to one since early March 2020.
During the usual chatting about jobs, music, my kids, and trips we were thinking about, one of her friends suddenly said: “That’s funny.”
I asked him what was funny, and he said: “My left vision suddenly went dark.”
It only takes a fraction of a second to shift into doctor mode. I asked a few pointed questions and did a quick neuroscan for asymmetries, slurred speech, the things that, after 23 years, have become second nature.
It resolved after about 30 seconds. He clearly didn’t think it was anything to be alarmed about. He’s intelligent and well educated, but not a doctor. I wasn’t going to let it go, and quietly spoke to him a short while later. He may not be my patient, but pushing him in the needed direction is the right thing to do.
I’ve gotten him to the right doctors now, and the ball is rolling, but I keep thinking about it. If I hadn’t been there it’s likely nothing would have been done. In fact, he seemed to think it was more amusing than potentially serious.
Medical blogs and doctors’ lounge stories are full of similar anecdotes, where we wonder why people don’t take such things seriously. We tend to view such people as stupid and/or ignorant.
Yet, this gentleman is neither. I’ve known him since childhood. He’s smart, well educated, and well read. He’s not a medical person, though.
In reality, I don’t think doctors or nurses are any better. I suspect that’s more human nature, which is hard to override regardless of training.
But maybe it’s time to start giving these people, like my family friend, a pass, with the realization that denial and different training are part of being human, and not something to be poked fun at.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Now that everyone in my family has been vaccinated, we’re starting to do more.
Last week we met my mom and some of her (vaccinated) friends for dinner at a local restaurant. Except for picking up takeout, I hadn’t been to one since early March 2020.
During the usual chatting about jobs, music, my kids, and trips we were thinking about, one of her friends suddenly said: “That’s funny.”
I asked him what was funny, and he said: “My left vision suddenly went dark.”
It only takes a fraction of a second to shift into doctor mode. I asked a few pointed questions and did a quick neuroscan for asymmetries, slurred speech, the things that, after 23 years, have become second nature.
It resolved after about 30 seconds. He clearly didn’t think it was anything to be alarmed about. He’s intelligent and well educated, but not a doctor. I wasn’t going to let it go, and quietly spoke to him a short while later. He may not be my patient, but pushing him in the needed direction is the right thing to do.
I’ve gotten him to the right doctors now, and the ball is rolling, but I keep thinking about it. If I hadn’t been there it’s likely nothing would have been done. In fact, he seemed to think it was more amusing than potentially serious.
Medical blogs and doctors’ lounge stories are full of similar anecdotes, where we wonder why people don’t take such things seriously. We tend to view such people as stupid and/or ignorant.
Yet, this gentleman is neither. I’ve known him since childhood. He’s smart, well educated, and well read. He’s not a medical person, though.
In reality, I don’t think doctors or nurses are any better. I suspect that’s more human nature, which is hard to override regardless of training.
But maybe it’s time to start giving these people, like my family friend, a pass, with the realization that denial and different training are part of being human, and not something to be poked fun at.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Targetoid eruption
The clinical features of targetoid lesions occurring soon after herpes simplex virus (HSV) infection points to a diagnosis of erythema multiforme (EM), which was confirmed by punch biopsy. The differential diagnosis for targetoid small lesions includes granuloma annulare, pityriasis rosea, and linear IgA bullous dermatosis. Larger targetoid lesions would be more concerning for erythema migrans (Lyme disease), tumid lupus, and severe tinea corporis.
Erythema multiforme represents an immune reaction triggered most often by HSV. About 10% of cases are triggered by exposure to various other viruses, drugs, and bacteria—notably, Mycoplasma pneumonia.1 Symptoms vary from mildly uncomfortable crops of annular and targetoid plaques to widespread annular plaques and bullae.
In the past, EM was considered a clinical variant along a continuum with Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). Although mucosal involvement may occur with EM, it never progresses to SJS or TEN. The latter 2 diagnoses are associated with significant skin pain, dusky confluent patches, and a positive Nikolsky sign—wherein skin pressure causes superficial separation of the epidermis. Additionally, SJS and TEN tend to involve the trunk, whereas EM typically involves acral surfaces.
EM is self-limited but may recur in patients with additional HSV flares. Patients with frequent recurrences benefit from long-term suppression of HSV with valacyclovir 500 mg bid. Nonsteroidal anti-inflammatory drugs and cool compresses control mild pain. Itching may be relieved with topical, medium-potency steroids or oral antihistamines. Oral ulcers or lesions may be treated with lidocaine oral suspension. Systemic steroids are contraindicated for mild disease, but they have a somewhat controversial role in alleviating severe symptoms.
This patient had mild symptoms and tolerated topical triamcinolone 0.1% cream bid without recurrence at 6 months.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
1. Trayes KP, Love G, Studdiford JS. Erythema multiforme: recognition and management. Am Fam Physician. 2019;100:82-88.
The clinical features of targetoid lesions occurring soon after herpes simplex virus (HSV) infection points to a diagnosis of erythema multiforme (EM), which was confirmed by punch biopsy. The differential diagnosis for targetoid small lesions includes granuloma annulare, pityriasis rosea, and linear IgA bullous dermatosis. Larger targetoid lesions would be more concerning for erythema migrans (Lyme disease), tumid lupus, and severe tinea corporis.
Erythema multiforme represents an immune reaction triggered most often by HSV. About 10% of cases are triggered by exposure to various other viruses, drugs, and bacteria—notably, Mycoplasma pneumonia.1 Symptoms vary from mildly uncomfortable crops of annular and targetoid plaques to widespread annular plaques and bullae.
In the past, EM was considered a clinical variant along a continuum with Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). Although mucosal involvement may occur with EM, it never progresses to SJS or TEN. The latter 2 diagnoses are associated with significant skin pain, dusky confluent patches, and a positive Nikolsky sign—wherein skin pressure causes superficial separation of the epidermis. Additionally, SJS and TEN tend to involve the trunk, whereas EM typically involves acral surfaces.
EM is self-limited but may recur in patients with additional HSV flares. Patients with frequent recurrences benefit from long-term suppression of HSV with valacyclovir 500 mg bid. Nonsteroidal anti-inflammatory drugs and cool compresses control mild pain. Itching may be relieved with topical, medium-potency steroids or oral antihistamines. Oral ulcers or lesions may be treated with lidocaine oral suspension. Systemic steroids are contraindicated for mild disease, but they have a somewhat controversial role in alleviating severe symptoms.
This patient had mild symptoms and tolerated topical triamcinolone 0.1% cream bid without recurrence at 6 months.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
The clinical features of targetoid lesions occurring soon after herpes simplex virus (HSV) infection points to a diagnosis of erythema multiforme (EM), which was confirmed by punch biopsy. The differential diagnosis for targetoid small lesions includes granuloma annulare, pityriasis rosea, and linear IgA bullous dermatosis. Larger targetoid lesions would be more concerning for erythema migrans (Lyme disease), tumid lupus, and severe tinea corporis.
Erythema multiforme represents an immune reaction triggered most often by HSV. About 10% of cases are triggered by exposure to various other viruses, drugs, and bacteria—notably, Mycoplasma pneumonia.1 Symptoms vary from mildly uncomfortable crops of annular and targetoid plaques to widespread annular plaques and bullae.
In the past, EM was considered a clinical variant along a continuum with Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). Although mucosal involvement may occur with EM, it never progresses to SJS or TEN. The latter 2 diagnoses are associated with significant skin pain, dusky confluent patches, and a positive Nikolsky sign—wherein skin pressure causes superficial separation of the epidermis. Additionally, SJS and TEN tend to involve the trunk, whereas EM typically involves acral surfaces.
EM is self-limited but may recur in patients with additional HSV flares. Patients with frequent recurrences benefit from long-term suppression of HSV with valacyclovir 500 mg bid. Nonsteroidal anti-inflammatory drugs and cool compresses control mild pain. Itching may be relieved with topical, medium-potency steroids or oral antihistamines. Oral ulcers or lesions may be treated with lidocaine oral suspension. Systemic steroids are contraindicated for mild disease, but they have a somewhat controversial role in alleviating severe symptoms.
This patient had mild symptoms and tolerated topical triamcinolone 0.1% cream bid without recurrence at 6 months.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
1. Trayes KP, Love G, Studdiford JS. Erythema multiforme: recognition and management. Am Fam Physician. 2019;100:82-88.
1. Trayes KP, Love G, Studdiford JS. Erythema multiforme: recognition and management. Am Fam Physician. 2019;100:82-88.