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Novel antidepressant shines in phase 2 trial, but FDA has issues with its NDA
Although a novel investigational drug that combines dextromethorphan and bupropion (AXS-05, Axsome Therapeutics) met its primary and key secondary endpoints in a phase 2 trial of patients with treatment-resistant depression (TRD), the U.S. Food and Drug Administration has voiced some concerns.
In the MERIT study, AXS-05 significantly delayed time to depression relapse compared with placebo (primary endpoint) – with no relapses observed for at least 6 months. It also significantly prevented depression relapse (secondary endpoint), the company said in a news release announcing the topline results.
The drug has been granted breakthrough therapy designations by the FDA for the treatment of major depressive disorder (MDD) and agitation associated with Alzheimer’s disease.
In addition,
However, Axsome stated that the FDA has identified “deficiencies that preclude labeling discussions at this time.”
The company is “attempting to learn the nature of these deficiencies with the goal of addressing them,” Herriot Tabuteau, MD, chief executive officer of Axsome, said in a statement.
However, Dr. Tabuteau acknowledged that this development “may lead to a delay in the potential approval of AXS-05.”
‘Well tolerated’
A total of 44 adults with TRD were enrolled into the MERIT study from the long-term, open-label phase 3 trial of AXS-05.
All patients were in stable remission after treatment with AXS-05 and were randomly assigned to continued treatment with AXS-05 (45 mg dextromethorphan/105 mg bupropion twice daily) or to switch to placebo.
Compared with placebo, AXS-05 significantly delayed time to depression relapse (P = .002) and prevented depression relapse (P = .004).
The novel drug was also well tolerated, with no treatment-emergent adverse events reported in more than one participant in the AXS-05 group, the company said.
One patient treated with AXS-05 did experience gout and bacteremia, but these incidents were deemed unrelated to the medication.
A version of this article first appeared on Medscape.com.
Although a novel investigational drug that combines dextromethorphan and bupropion (AXS-05, Axsome Therapeutics) met its primary and key secondary endpoints in a phase 2 trial of patients with treatment-resistant depression (TRD), the U.S. Food and Drug Administration has voiced some concerns.
In the MERIT study, AXS-05 significantly delayed time to depression relapse compared with placebo (primary endpoint) – with no relapses observed for at least 6 months. It also significantly prevented depression relapse (secondary endpoint), the company said in a news release announcing the topline results.
The drug has been granted breakthrough therapy designations by the FDA for the treatment of major depressive disorder (MDD) and agitation associated with Alzheimer’s disease.
In addition,
However, Axsome stated that the FDA has identified “deficiencies that preclude labeling discussions at this time.”
The company is “attempting to learn the nature of these deficiencies with the goal of addressing them,” Herriot Tabuteau, MD, chief executive officer of Axsome, said in a statement.
However, Dr. Tabuteau acknowledged that this development “may lead to a delay in the potential approval of AXS-05.”
‘Well tolerated’
A total of 44 adults with TRD were enrolled into the MERIT study from the long-term, open-label phase 3 trial of AXS-05.
All patients were in stable remission after treatment with AXS-05 and were randomly assigned to continued treatment with AXS-05 (45 mg dextromethorphan/105 mg bupropion twice daily) or to switch to placebo.
Compared with placebo, AXS-05 significantly delayed time to depression relapse (P = .002) and prevented depression relapse (P = .004).
The novel drug was also well tolerated, with no treatment-emergent adverse events reported in more than one participant in the AXS-05 group, the company said.
One patient treated with AXS-05 did experience gout and bacteremia, but these incidents were deemed unrelated to the medication.
A version of this article first appeared on Medscape.com.
Although a novel investigational drug that combines dextromethorphan and bupropion (AXS-05, Axsome Therapeutics) met its primary and key secondary endpoints in a phase 2 trial of patients with treatment-resistant depression (TRD), the U.S. Food and Drug Administration has voiced some concerns.
In the MERIT study, AXS-05 significantly delayed time to depression relapse compared with placebo (primary endpoint) – with no relapses observed for at least 6 months. It also significantly prevented depression relapse (secondary endpoint), the company said in a news release announcing the topline results.
The drug has been granted breakthrough therapy designations by the FDA for the treatment of major depressive disorder (MDD) and agitation associated with Alzheimer’s disease.
In addition,
However, Axsome stated that the FDA has identified “deficiencies that preclude labeling discussions at this time.”
The company is “attempting to learn the nature of these deficiencies with the goal of addressing them,” Herriot Tabuteau, MD, chief executive officer of Axsome, said in a statement.
However, Dr. Tabuteau acknowledged that this development “may lead to a delay in the potential approval of AXS-05.”
‘Well tolerated’
A total of 44 adults with TRD were enrolled into the MERIT study from the long-term, open-label phase 3 trial of AXS-05.
All patients were in stable remission after treatment with AXS-05 and were randomly assigned to continued treatment with AXS-05 (45 mg dextromethorphan/105 mg bupropion twice daily) or to switch to placebo.
Compared with placebo, AXS-05 significantly delayed time to depression relapse (P = .002) and prevented depression relapse (P = .004).
The novel drug was also well tolerated, with no treatment-emergent adverse events reported in more than one participant in the AXS-05 group, the company said.
One patient treated with AXS-05 did experience gout and bacteremia, but these incidents were deemed unrelated to the medication.
A version of this article first appeared on Medscape.com.
Move from awareness to action to combat racism in medicine
Structural racism and implicit bias are connected, and both must be addressed to move from awareness of racism to action, said Nathan Chomilo, MD, of HealthPartners/Park Nicollet, Brooklyn Center, Minn., in a presentation at the virtual Pediatric Hospital Medicine annual conference.
“We need pediatricians with the courage to address racism head on,” he said.
One step in moving from awareness to action against structural and institutional racism in medicine is examining policies, Dr. Chomilo said. He cited the creation of Medicare and Medicaid in 1965 as examples of how policy changes can make a difference, illustrated by data from 1955-1975 that showed a significant decrease in infant deaths among Black infants in Mississippi after 1965.
Medicaid expansion has helped to narrow, but not eliminate, racial disparities in health care, Dr. Chomilo said. The impact of Medicare and Medicaid is evident in the current COVID-19 pandemic, as county level data show that areas where more than 25% of the population are uninsured have higher rates of COVID-19 infections, said Dr. Chomilo. Policies that impact access to care also impact their incidence of chronic diseases and risk for severe disease, he noted.
“If you don’t have ready access to a health care provider, you don’t have access to the vaccine, and you don’t have information that would inform your getting the vaccine,” he added.
Prioritizing the power of voting
“Voting is one of many ways we can impact structural racism in health care policy,” Dr. Chomilo emphasized.
However, voting inequity remains a challenge, Dr. Chomilo noted. Community level disparities lead to inequity in voting access and subsequent disparities in voter participation, he said. “Leaders are less responsive to nonvoting constituents,” which can result in policies that impact health inequitably, and loop back to community level health disparities, he explained.
Historically, physicians have had an 8%-9% lower voter turnout than the general public, although this may have changed in recent elections, Dr. Chomilo said. He encouraged all clinicians to set an example and vote, and to empower their patients to vote. Evidence shows that enfranchisement of Black voters is associated with reductions in education gaps for Blacks and Whites, and that enfranchisement of women is associated with increased spending on children and lower child mortality, he said. Dr. Chomilo encouraged pediatricians and all clinicians to take advantage of the resources on voting available from the American Academy of Pediatrics (aap.org/votekids).
“When we see more people in a community vote, leaders are more responsive to their needs,” he said.
Informing racial identity
“Racial identity is informed by racial socialization,” Dr. Chomilo said. “All of us are socialized along the lines of race; it happens in conversations with parents, family, peers, community.” Another point in moving from awareness to action in eliminating structural racism is recognizing that children are not too young to talk about race, Dr. Chomilo emphasized.
Children start to navigate racial identity and to take note of other differences at an early age. For example, a 3-year-old might ask, “why does that person talk funny, why is that person being pushed in a chair?” Dr. Chomilo said, and it is important for parents and as pediatricians to be prepared for these questions, which are part of normal development. As children get older, they start to reflect on what differences mean for them, which is not rooted in anything negative, he noted.
Children first develop racial identity at home, but children solidify their identities in child care and school settings, Dr. Chomilo said. The American Academy of Pediatrics has acknowledged the potential for racial bias in education and child care, and said in a statement that, “it is critical for pediatricians to recognize the institutional personally mediated, and internalized levels of racism that occur in the educational setting, because education is a critical social determinant of health for children.” In fact, data from children in preschool show that they use racial categories to identify themselves and others, to include or exclude children from activities, and to negotiate power in their social and play networks.
Early intervention matters in educating children about racism, Dr. Chomilo said. “If we were not taught to talk about race, it is on us to learn about it ourselves as well,” he said.
Ultimately, the goal is to create active antiracism among adults and children, said Dr. Chomilo. He encouraged pediatricians and parents not to shut down or discourage children when they raise questions of race, but to take the opportunity to teach. “There may be hurt feelings around what a child said, even if they didn’t mean to offend someone,” he noted. Take the topic seriously, and make racism conversations ongoing; teach children to safely oppose negative messages and behaviors in others, and replace them with something positive, he emphasized.
Addressing bias in clinical settings
Dr. Chomilo also encouraged hospitalists to consider internalized racism in clinical settings and take action to build confidence and cultural pride in all patients by ensuring that a pediatric hospital unit is welcoming and representative of the diversity in a given community, with appropriate options for books, movies, and toys. He also encouraged pediatric hospitalists to assess children for experiences of racism as part of a social assessment. Be aware of signs of posttraumatic stress, anxiety, depression, or grief that might have a racial component, he said.
Dr. Chomilo had no financial conflicts to disclose.
Structural racism and implicit bias are connected, and both must be addressed to move from awareness of racism to action, said Nathan Chomilo, MD, of HealthPartners/Park Nicollet, Brooklyn Center, Minn., in a presentation at the virtual Pediatric Hospital Medicine annual conference.
“We need pediatricians with the courage to address racism head on,” he said.
One step in moving from awareness to action against structural and institutional racism in medicine is examining policies, Dr. Chomilo said. He cited the creation of Medicare and Medicaid in 1965 as examples of how policy changes can make a difference, illustrated by data from 1955-1975 that showed a significant decrease in infant deaths among Black infants in Mississippi after 1965.
Medicaid expansion has helped to narrow, but not eliminate, racial disparities in health care, Dr. Chomilo said. The impact of Medicare and Medicaid is evident in the current COVID-19 pandemic, as county level data show that areas where more than 25% of the population are uninsured have higher rates of COVID-19 infections, said Dr. Chomilo. Policies that impact access to care also impact their incidence of chronic diseases and risk for severe disease, he noted.
“If you don’t have ready access to a health care provider, you don’t have access to the vaccine, and you don’t have information that would inform your getting the vaccine,” he added.
Prioritizing the power of voting
“Voting is one of many ways we can impact structural racism in health care policy,” Dr. Chomilo emphasized.
However, voting inequity remains a challenge, Dr. Chomilo noted. Community level disparities lead to inequity in voting access and subsequent disparities in voter participation, he said. “Leaders are less responsive to nonvoting constituents,” which can result in policies that impact health inequitably, and loop back to community level health disparities, he explained.
Historically, physicians have had an 8%-9% lower voter turnout than the general public, although this may have changed in recent elections, Dr. Chomilo said. He encouraged all clinicians to set an example and vote, and to empower their patients to vote. Evidence shows that enfranchisement of Black voters is associated with reductions in education gaps for Blacks and Whites, and that enfranchisement of women is associated with increased spending on children and lower child mortality, he said. Dr. Chomilo encouraged pediatricians and all clinicians to take advantage of the resources on voting available from the American Academy of Pediatrics (aap.org/votekids).
“When we see more people in a community vote, leaders are more responsive to their needs,” he said.
Informing racial identity
“Racial identity is informed by racial socialization,” Dr. Chomilo said. “All of us are socialized along the lines of race; it happens in conversations with parents, family, peers, community.” Another point in moving from awareness to action in eliminating structural racism is recognizing that children are not too young to talk about race, Dr. Chomilo emphasized.
Children start to navigate racial identity and to take note of other differences at an early age. For example, a 3-year-old might ask, “why does that person talk funny, why is that person being pushed in a chair?” Dr. Chomilo said, and it is important for parents and as pediatricians to be prepared for these questions, which are part of normal development. As children get older, they start to reflect on what differences mean for them, which is not rooted in anything negative, he noted.
Children first develop racial identity at home, but children solidify their identities in child care and school settings, Dr. Chomilo said. The American Academy of Pediatrics has acknowledged the potential for racial bias in education and child care, and said in a statement that, “it is critical for pediatricians to recognize the institutional personally mediated, and internalized levels of racism that occur in the educational setting, because education is a critical social determinant of health for children.” In fact, data from children in preschool show that they use racial categories to identify themselves and others, to include or exclude children from activities, and to negotiate power in their social and play networks.
Early intervention matters in educating children about racism, Dr. Chomilo said. “If we were not taught to talk about race, it is on us to learn about it ourselves as well,” he said.
Ultimately, the goal is to create active antiracism among adults and children, said Dr. Chomilo. He encouraged pediatricians and parents not to shut down or discourage children when they raise questions of race, but to take the opportunity to teach. “There may be hurt feelings around what a child said, even if they didn’t mean to offend someone,” he noted. Take the topic seriously, and make racism conversations ongoing; teach children to safely oppose negative messages and behaviors in others, and replace them with something positive, he emphasized.
Addressing bias in clinical settings
Dr. Chomilo also encouraged hospitalists to consider internalized racism in clinical settings and take action to build confidence and cultural pride in all patients by ensuring that a pediatric hospital unit is welcoming and representative of the diversity in a given community, with appropriate options for books, movies, and toys. He also encouraged pediatric hospitalists to assess children for experiences of racism as part of a social assessment. Be aware of signs of posttraumatic stress, anxiety, depression, or grief that might have a racial component, he said.
Dr. Chomilo had no financial conflicts to disclose.
Structural racism and implicit bias are connected, and both must be addressed to move from awareness of racism to action, said Nathan Chomilo, MD, of HealthPartners/Park Nicollet, Brooklyn Center, Minn., in a presentation at the virtual Pediatric Hospital Medicine annual conference.
“We need pediatricians with the courage to address racism head on,” he said.
One step in moving from awareness to action against structural and institutional racism in medicine is examining policies, Dr. Chomilo said. He cited the creation of Medicare and Medicaid in 1965 as examples of how policy changes can make a difference, illustrated by data from 1955-1975 that showed a significant decrease in infant deaths among Black infants in Mississippi after 1965.
Medicaid expansion has helped to narrow, but not eliminate, racial disparities in health care, Dr. Chomilo said. The impact of Medicare and Medicaid is evident in the current COVID-19 pandemic, as county level data show that areas where more than 25% of the population are uninsured have higher rates of COVID-19 infections, said Dr. Chomilo. Policies that impact access to care also impact their incidence of chronic diseases and risk for severe disease, he noted.
“If you don’t have ready access to a health care provider, you don’t have access to the vaccine, and you don’t have information that would inform your getting the vaccine,” he added.
Prioritizing the power of voting
“Voting is one of many ways we can impact structural racism in health care policy,” Dr. Chomilo emphasized.
However, voting inequity remains a challenge, Dr. Chomilo noted. Community level disparities lead to inequity in voting access and subsequent disparities in voter participation, he said. “Leaders are less responsive to nonvoting constituents,” which can result in policies that impact health inequitably, and loop back to community level health disparities, he explained.
Historically, physicians have had an 8%-9% lower voter turnout than the general public, although this may have changed in recent elections, Dr. Chomilo said. He encouraged all clinicians to set an example and vote, and to empower their patients to vote. Evidence shows that enfranchisement of Black voters is associated with reductions in education gaps for Blacks and Whites, and that enfranchisement of women is associated with increased spending on children and lower child mortality, he said. Dr. Chomilo encouraged pediatricians and all clinicians to take advantage of the resources on voting available from the American Academy of Pediatrics (aap.org/votekids).
“When we see more people in a community vote, leaders are more responsive to their needs,” he said.
Informing racial identity
“Racial identity is informed by racial socialization,” Dr. Chomilo said. “All of us are socialized along the lines of race; it happens in conversations with parents, family, peers, community.” Another point in moving from awareness to action in eliminating structural racism is recognizing that children are not too young to talk about race, Dr. Chomilo emphasized.
Children start to navigate racial identity and to take note of other differences at an early age. For example, a 3-year-old might ask, “why does that person talk funny, why is that person being pushed in a chair?” Dr. Chomilo said, and it is important for parents and as pediatricians to be prepared for these questions, which are part of normal development. As children get older, they start to reflect on what differences mean for them, which is not rooted in anything negative, he noted.
Children first develop racial identity at home, but children solidify their identities in child care and school settings, Dr. Chomilo said. The American Academy of Pediatrics has acknowledged the potential for racial bias in education and child care, and said in a statement that, “it is critical for pediatricians to recognize the institutional personally mediated, and internalized levels of racism that occur in the educational setting, because education is a critical social determinant of health for children.” In fact, data from children in preschool show that they use racial categories to identify themselves and others, to include or exclude children from activities, and to negotiate power in their social and play networks.
Early intervention matters in educating children about racism, Dr. Chomilo said. “If we were not taught to talk about race, it is on us to learn about it ourselves as well,” he said.
Ultimately, the goal is to create active antiracism among adults and children, said Dr. Chomilo. He encouraged pediatricians and parents not to shut down or discourage children when they raise questions of race, but to take the opportunity to teach. “There may be hurt feelings around what a child said, even if they didn’t mean to offend someone,” he noted. Take the topic seriously, and make racism conversations ongoing; teach children to safely oppose negative messages and behaviors in others, and replace them with something positive, he emphasized.
Addressing bias in clinical settings
Dr. Chomilo also encouraged hospitalists to consider internalized racism in clinical settings and take action to build confidence and cultural pride in all patients by ensuring that a pediatric hospital unit is welcoming and representative of the diversity in a given community, with appropriate options for books, movies, and toys. He also encouraged pediatric hospitalists to assess children for experiences of racism as part of a social assessment. Be aware of signs of posttraumatic stress, anxiety, depression, or grief that might have a racial component, he said.
Dr. Chomilo had no financial conflicts to disclose.
FROM PHM 2021
SHM’s Center for Quality Improvement to partner on NIH grant
The Society of Hospital Medicine has announced that its award-winning Center for Quality Improvement will partner on the National Institutes of Health National, Heart, Lung, and Blood Institute study, “The SIP Study: Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children” (NIH R61HL157804). The core objectives of the planned 5-year study are to identify and test practical, sustainable strategies for implementing a multicondition clinical pathway intervention for children hospitalized with asthma, pneumonia, or bronchiolitis in community hospitals.
Under the leadership of principal investigator Sunitha Kaiser, MD, MSc, a pediatric hospitalist at the University of California, San Francisco, the study will employ rigorous implementation science methods and SHM’s mentored implementation model.
“The lessons learned from this study could inform improved care delivery strategies for the millions of children hospitalized with respiratory illnesses across the U.S. each year,” said Jenna Goldstein, chief of strategic partnerships at SHM and director of SHM’s Center for Quality Improvement.
The team will recruit a diverse group of community hospitals in partnership with SHM, the Value in Inpatient Pediatrics Network (within the American Academy of Pediatrics), the Pediatric Research in Inpatient Settings Network, America’s Hospital Essentials, and the National Improvement Partnership Network. In collaboration with these national organizations and the participating hospitals, the team seeks to realize the following aims:
- Aim 1. (Preimplementation) Identify barriers and facilitators of implementing a multicondition pathway intervention and refine the intervention for community hospitals.
- Aim 2a. Determine the effects of the intervention, compared with control via chart reviews of children hospitalized with asthma, pneumonia, or bronchiolitis.
- Aim 2b. Determine if the core implementation strategies (audit and feedback, electronic order sets, Plan-Do-Study-Act cycles) are associated with clinicians’ guideline adoption.
“SHM’s Center for Quality Improvement is a recognized partner in facilitating process and culture change in the hospital to improve outcomes for patients,” said Eric E. Howell, MD, MHM, chief executive officer of SHM. “SHM is committed to supporting quality-improvement research, and we look forward to contributing to improved care for hospitalized pediatric patients through this study and beyond.”
To learn more about SHM’s Center for Quality Improvement, visit hospitalmedicine.org/qi.
The Society of Hospital Medicine has announced that its award-winning Center for Quality Improvement will partner on the National Institutes of Health National, Heart, Lung, and Blood Institute study, “The SIP Study: Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children” (NIH R61HL157804). The core objectives of the planned 5-year study are to identify and test practical, sustainable strategies for implementing a multicondition clinical pathway intervention for children hospitalized with asthma, pneumonia, or bronchiolitis in community hospitals.
Under the leadership of principal investigator Sunitha Kaiser, MD, MSc, a pediatric hospitalist at the University of California, San Francisco, the study will employ rigorous implementation science methods and SHM’s mentored implementation model.
“The lessons learned from this study could inform improved care delivery strategies for the millions of children hospitalized with respiratory illnesses across the U.S. each year,” said Jenna Goldstein, chief of strategic partnerships at SHM and director of SHM’s Center for Quality Improvement.
The team will recruit a diverse group of community hospitals in partnership with SHM, the Value in Inpatient Pediatrics Network (within the American Academy of Pediatrics), the Pediatric Research in Inpatient Settings Network, America’s Hospital Essentials, and the National Improvement Partnership Network. In collaboration with these national organizations and the participating hospitals, the team seeks to realize the following aims:
- Aim 1. (Preimplementation) Identify barriers and facilitators of implementing a multicondition pathway intervention and refine the intervention for community hospitals.
- Aim 2a. Determine the effects of the intervention, compared with control via chart reviews of children hospitalized with asthma, pneumonia, or bronchiolitis.
- Aim 2b. Determine if the core implementation strategies (audit and feedback, electronic order sets, Plan-Do-Study-Act cycles) are associated with clinicians’ guideline adoption.
“SHM’s Center for Quality Improvement is a recognized partner in facilitating process and culture change in the hospital to improve outcomes for patients,” said Eric E. Howell, MD, MHM, chief executive officer of SHM. “SHM is committed to supporting quality-improvement research, and we look forward to contributing to improved care for hospitalized pediatric patients through this study and beyond.”
To learn more about SHM’s Center for Quality Improvement, visit hospitalmedicine.org/qi.
The Society of Hospital Medicine has announced that its award-winning Center for Quality Improvement will partner on the National Institutes of Health National, Heart, Lung, and Blood Institute study, “The SIP Study: Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children” (NIH R61HL157804). The core objectives of the planned 5-year study are to identify and test practical, sustainable strategies for implementing a multicondition clinical pathway intervention for children hospitalized with asthma, pneumonia, or bronchiolitis in community hospitals.
Under the leadership of principal investigator Sunitha Kaiser, MD, MSc, a pediatric hospitalist at the University of California, San Francisco, the study will employ rigorous implementation science methods and SHM’s mentored implementation model.
“The lessons learned from this study could inform improved care delivery strategies for the millions of children hospitalized with respiratory illnesses across the U.S. each year,” said Jenna Goldstein, chief of strategic partnerships at SHM and director of SHM’s Center for Quality Improvement.
The team will recruit a diverse group of community hospitals in partnership with SHM, the Value in Inpatient Pediatrics Network (within the American Academy of Pediatrics), the Pediatric Research in Inpatient Settings Network, America’s Hospital Essentials, and the National Improvement Partnership Network. In collaboration with these national organizations and the participating hospitals, the team seeks to realize the following aims:
- Aim 1. (Preimplementation) Identify barriers and facilitators of implementing a multicondition pathway intervention and refine the intervention for community hospitals.
- Aim 2a. Determine the effects of the intervention, compared with control via chart reviews of children hospitalized with asthma, pneumonia, or bronchiolitis.
- Aim 2b. Determine if the core implementation strategies (audit and feedback, electronic order sets, Plan-Do-Study-Act cycles) are associated with clinicians’ guideline adoption.
“SHM’s Center for Quality Improvement is a recognized partner in facilitating process and culture change in the hospital to improve outcomes for patients,” said Eric E. Howell, MD, MHM, chief executive officer of SHM. “SHM is committed to supporting quality-improvement research, and we look forward to contributing to improved care for hospitalized pediatric patients through this study and beyond.”
To learn more about SHM’s Center for Quality Improvement, visit hospitalmedicine.org/qi.
German nurse suspected of giving saline instead of COVID-19 vaccine
Those who may be affected are being informed about their possible vulnerability to the coronavirus and will be offered COVID-19 shots, according to CBS News.
“I’m totally shocked by the incident,” Sven Ambrosy, a district administrator of Friesland, wrote in a Facebook post on Aug. 10.
“The district of Friesland will do everything possible to ensure that the affected people receive their vaccination protection as soon as possible,” he said.
In late April, a former Red Cross employee who worked at the Roffhausen Vaccination Center in Friesland, a district in Germany’s northern state of Lower Saxony, told a colleague that she filled six syringes with saline instead of the Pfizer vaccine, according to police reports. The nurse said she dropped a vial containing the vaccine while preparing syringes and tried to cover it up.
The nurse was immediately fired, and local authorities conducted antibody tests on more than 100 people who visited the vaccination center on April 21. Since it was impossible to trace who received the saline shots, everyone who visited the center that day was invited to receive a follow-up shot.
But during a police investigation, authorities found evidence that more people were affected. The case now involves 8,557 vaccinations given between March 5 and April 20 at specific times.
Now, authorities are contacting those who were affected by phone or email to schedule new vaccination appointments. They’ve established a dedicated information phone line as well, according to NPR.
Saline solution is harmless, but most people who received shots in Germany during that time were older adults, who are more likely to have severe COVID-19 if infected, according to Reuters.
The nurse has remained silent about the allegations of her giving saline rather than a vaccine to thousands of people, CBS News reported. And it’s unclear whether there have been any arrests or charges related to the case, according to Reuters.
The nurse hasn’t been named publicly, and the motive hasn’t been shared, NPR reported, though the nurse had purportedly expressed skepticism about COVID-19 vaccines in social media posts.
A version of this article first appeared on WebMD.com.
Those who may be affected are being informed about their possible vulnerability to the coronavirus and will be offered COVID-19 shots, according to CBS News.
“I’m totally shocked by the incident,” Sven Ambrosy, a district administrator of Friesland, wrote in a Facebook post on Aug. 10.
“The district of Friesland will do everything possible to ensure that the affected people receive their vaccination protection as soon as possible,” he said.
In late April, a former Red Cross employee who worked at the Roffhausen Vaccination Center in Friesland, a district in Germany’s northern state of Lower Saxony, told a colleague that she filled six syringes with saline instead of the Pfizer vaccine, according to police reports. The nurse said she dropped a vial containing the vaccine while preparing syringes and tried to cover it up.
The nurse was immediately fired, and local authorities conducted antibody tests on more than 100 people who visited the vaccination center on April 21. Since it was impossible to trace who received the saline shots, everyone who visited the center that day was invited to receive a follow-up shot.
But during a police investigation, authorities found evidence that more people were affected. The case now involves 8,557 vaccinations given between March 5 and April 20 at specific times.
Now, authorities are contacting those who were affected by phone or email to schedule new vaccination appointments. They’ve established a dedicated information phone line as well, according to NPR.
Saline solution is harmless, but most people who received shots in Germany during that time were older adults, who are more likely to have severe COVID-19 if infected, according to Reuters.
The nurse has remained silent about the allegations of her giving saline rather than a vaccine to thousands of people, CBS News reported. And it’s unclear whether there have been any arrests or charges related to the case, according to Reuters.
The nurse hasn’t been named publicly, and the motive hasn’t been shared, NPR reported, though the nurse had purportedly expressed skepticism about COVID-19 vaccines in social media posts.
A version of this article first appeared on WebMD.com.
Those who may be affected are being informed about their possible vulnerability to the coronavirus and will be offered COVID-19 shots, according to CBS News.
“I’m totally shocked by the incident,” Sven Ambrosy, a district administrator of Friesland, wrote in a Facebook post on Aug. 10.
“The district of Friesland will do everything possible to ensure that the affected people receive their vaccination protection as soon as possible,” he said.
In late April, a former Red Cross employee who worked at the Roffhausen Vaccination Center in Friesland, a district in Germany’s northern state of Lower Saxony, told a colleague that she filled six syringes with saline instead of the Pfizer vaccine, according to police reports. The nurse said she dropped a vial containing the vaccine while preparing syringes and tried to cover it up.
The nurse was immediately fired, and local authorities conducted antibody tests on more than 100 people who visited the vaccination center on April 21. Since it was impossible to trace who received the saline shots, everyone who visited the center that day was invited to receive a follow-up shot.
But during a police investigation, authorities found evidence that more people were affected. The case now involves 8,557 vaccinations given between March 5 and April 20 at specific times.
Now, authorities are contacting those who were affected by phone or email to schedule new vaccination appointments. They’ve established a dedicated information phone line as well, according to NPR.
Saline solution is harmless, but most people who received shots in Germany during that time were older adults, who are more likely to have severe COVID-19 if infected, according to Reuters.
The nurse has remained silent about the allegations of her giving saline rather than a vaccine to thousands of people, CBS News reported. And it’s unclear whether there have been any arrests or charges related to the case, according to Reuters.
The nurse hasn’t been named publicly, and the motive hasn’t been shared, NPR reported, though the nurse had purportedly expressed skepticism about COVID-19 vaccines in social media posts.
A version of this article first appeared on WebMD.com.
Hep B vaccine response varied among youth with inflammatory, autoimmune disorders
“Hepatitis B is a common viral infection with 2 billion people worldwide having evidence of prior or current infection, and it can present as an acute or chronic infection,” or with chronic sequelae, including cirrhosis and hepatocellular carcinoma, Alexandra Ritter said during the annual meeting of the Society for Pediatric Dermatology. A three-dose vaccination series is recommended beginning at birth, and in 2016, the Centers for Disease Control and Prevention reported that 90.5% of U.S. children aged 19-35 months had completed the series.
While the vaccine series provides protection in healthy individuals more than 95% of the time, a decreased response has been noted in specific pediatric populations, including those with inflammatory and autoimmune diseases. “This is important to note and investigate further because a decreased vaccine response increases the risk for this high-risk population, and the use of boosters is currently debated,” said Ms. Ritter, who is a fourth-year student at the Medical University of South Carolina, Charleston.
To determine the percent of pediatric patients with inflammatory or autoimmune disease who lack evidence of immunity following the hepatitis B vaccine series, Ms. Ritter and colleagues Abigail Truitt and pediatric dermatologist Lara Wine Lee, MD, PhD, of MUSC, retrospectively reviewed the charts of 160 patients between the ages of 6 months and 21 years, who were diagnosed with an autoimmune or autoinflammatory disease, or inflammatory bowel disease (IBD), and had documented evidence of vaccination and serologic testing prior to the start of immunosuppressive therapy.
Of the 160 patients, 100 (63%) had IBD, 34 (21%) had an autoimmune disease, 26 (16%) had an autoinflammatory disease, 89 (56%) were female, and their mean age was 15 years.
The researchers observed variation in the testing ordered between the three patient groups. Specifically, 88.2% of autoimmune patients had hepatitis B surface antigen (HBsAg) testing, compared with 96.15% of patients with an autoinflammatory disease and 67% of patients with IBD, while 76.47% of patients with an autoimmune disease had hepatitis B core antibody (anti-HBc) testing, compared with 88.46% of patients with an autoinflammatory disease and 31% of patients with IBD.
In addition, 82.35% of patients with an autoimmune disease had HBsAg testing, compared with 100% of patients with an autoinflammatory disease and 94% of patients with IBD.
Of the 148 patients who had HBsAg testing ordered and completed prior to starting an immunosuppressive drug, there was no statistically significant difference in the percent of patients showing evidence of an immune response to the hepatitis B vaccine (32.14% among patients with an autoimmune disease, 34.62% among patients with an autoinflammatory disease, and 31.91% among patients with IBD). Combined, 67.57% of tested negative for the hepatitis B surface antibody.
“Our study showed that the majority of these patients did not show serologic evidence of immunity despite being fully vaccinated,” Ms. Ritter said. “There was also variation in the testing ordered and a more standardized approach is needed in this high-risk population.” She acknowledged certain limitations of the study, including its retrospective design and lack of a control group.
“This brings us to our next question of whether this indicates a failure of the vaccine, or the way immunity is tested,” she continued. “The CDC and the European Consensus Group on Hepatitis B Immunity recommend a cutoff of greater than 10 mIU/mL. Those that achieve immunity are protected for up to 20 years due to immune memory, even if their antibody levels later drop. There have been rare cases of immunocompetent individuals having evidence of transient asymptomatic infections when antibody levels drop. The chronic disease has only been documented in infants born to positive mothers. In hemodialysis patients, however, clinically significant infections have been documented when antibody levels drop.”
The CDC only recommends postvaccination testing to infants born to positive mothers, health care workers at high risk, hemodialysis patients, people with HIV and other immunocompromised people, and needle-sharing partners of chronically infected people. This is completed 1-2 months following the third vaccine dose, and those with antibody levels less than 10 mIU/mL should be revaccinated. “As some groups do not respond to the vaccine series, alternative dosing and the intradermal vaccine have been studied and shown to be effective in certain groups,” she said.
When it comes to monitoring immunocompromised individuals and giving booster shots, however, there are conflicting recommendations. The CDC recommends yearly testing and booster shots when levels drop below 10 mIU/mL only in hemodialysis patients, while the European Consensus Group recommends testing every 6-12 months for immunocompromised individuals and boosters when their levels drop below 10 mIU/mL.
“The CDC has not yet determined if other immunocompromised individuals should receive a booster, with more research required, but studies have shown it to be effective,” Ms. Ritter said. In a similar study looking at evidence of immunity in children with connective tissue disease who were on immunosuppressive treatment, 50% had no evidence of protective antibodies, compared with 96% in the control group. “In that study, a booster shot was given, and protective antibody concentrations were found at follow-up,” she said.
The researchers reported having no financial disclosures.
[email protected]
“Hepatitis B is a common viral infection with 2 billion people worldwide having evidence of prior or current infection, and it can present as an acute or chronic infection,” or with chronic sequelae, including cirrhosis and hepatocellular carcinoma, Alexandra Ritter said during the annual meeting of the Society for Pediatric Dermatology. A three-dose vaccination series is recommended beginning at birth, and in 2016, the Centers for Disease Control and Prevention reported that 90.5% of U.S. children aged 19-35 months had completed the series.
While the vaccine series provides protection in healthy individuals more than 95% of the time, a decreased response has been noted in specific pediatric populations, including those with inflammatory and autoimmune diseases. “This is important to note and investigate further because a decreased vaccine response increases the risk for this high-risk population, and the use of boosters is currently debated,” said Ms. Ritter, who is a fourth-year student at the Medical University of South Carolina, Charleston.
To determine the percent of pediatric patients with inflammatory or autoimmune disease who lack evidence of immunity following the hepatitis B vaccine series, Ms. Ritter and colleagues Abigail Truitt and pediatric dermatologist Lara Wine Lee, MD, PhD, of MUSC, retrospectively reviewed the charts of 160 patients between the ages of 6 months and 21 years, who were diagnosed with an autoimmune or autoinflammatory disease, or inflammatory bowel disease (IBD), and had documented evidence of vaccination and serologic testing prior to the start of immunosuppressive therapy.
Of the 160 patients, 100 (63%) had IBD, 34 (21%) had an autoimmune disease, 26 (16%) had an autoinflammatory disease, 89 (56%) were female, and their mean age was 15 years.
The researchers observed variation in the testing ordered between the three patient groups. Specifically, 88.2% of autoimmune patients had hepatitis B surface antigen (HBsAg) testing, compared with 96.15% of patients with an autoinflammatory disease and 67% of patients with IBD, while 76.47% of patients with an autoimmune disease had hepatitis B core antibody (anti-HBc) testing, compared with 88.46% of patients with an autoinflammatory disease and 31% of patients with IBD.
In addition, 82.35% of patients with an autoimmune disease had HBsAg testing, compared with 100% of patients with an autoinflammatory disease and 94% of patients with IBD.
Of the 148 patients who had HBsAg testing ordered and completed prior to starting an immunosuppressive drug, there was no statistically significant difference in the percent of patients showing evidence of an immune response to the hepatitis B vaccine (32.14% among patients with an autoimmune disease, 34.62% among patients with an autoinflammatory disease, and 31.91% among patients with IBD). Combined, 67.57% of tested negative for the hepatitis B surface antibody.
“Our study showed that the majority of these patients did not show serologic evidence of immunity despite being fully vaccinated,” Ms. Ritter said. “There was also variation in the testing ordered and a more standardized approach is needed in this high-risk population.” She acknowledged certain limitations of the study, including its retrospective design and lack of a control group.
“This brings us to our next question of whether this indicates a failure of the vaccine, or the way immunity is tested,” she continued. “The CDC and the European Consensus Group on Hepatitis B Immunity recommend a cutoff of greater than 10 mIU/mL. Those that achieve immunity are protected for up to 20 years due to immune memory, even if their antibody levels later drop. There have been rare cases of immunocompetent individuals having evidence of transient asymptomatic infections when antibody levels drop. The chronic disease has only been documented in infants born to positive mothers. In hemodialysis patients, however, clinically significant infections have been documented when antibody levels drop.”
The CDC only recommends postvaccination testing to infants born to positive mothers, health care workers at high risk, hemodialysis patients, people with HIV and other immunocompromised people, and needle-sharing partners of chronically infected people. This is completed 1-2 months following the third vaccine dose, and those with antibody levels less than 10 mIU/mL should be revaccinated. “As some groups do not respond to the vaccine series, alternative dosing and the intradermal vaccine have been studied and shown to be effective in certain groups,” she said.
When it comes to monitoring immunocompromised individuals and giving booster shots, however, there are conflicting recommendations. The CDC recommends yearly testing and booster shots when levels drop below 10 mIU/mL only in hemodialysis patients, while the European Consensus Group recommends testing every 6-12 months for immunocompromised individuals and boosters when their levels drop below 10 mIU/mL.
“The CDC has not yet determined if other immunocompromised individuals should receive a booster, with more research required, but studies have shown it to be effective,” Ms. Ritter said. In a similar study looking at evidence of immunity in children with connective tissue disease who were on immunosuppressive treatment, 50% had no evidence of protective antibodies, compared with 96% in the control group. “In that study, a booster shot was given, and protective antibody concentrations were found at follow-up,” she said.
The researchers reported having no financial disclosures.
[email protected]
“Hepatitis B is a common viral infection with 2 billion people worldwide having evidence of prior or current infection, and it can present as an acute or chronic infection,” or with chronic sequelae, including cirrhosis and hepatocellular carcinoma, Alexandra Ritter said during the annual meeting of the Society for Pediatric Dermatology. A three-dose vaccination series is recommended beginning at birth, and in 2016, the Centers for Disease Control and Prevention reported that 90.5% of U.S. children aged 19-35 months had completed the series.
While the vaccine series provides protection in healthy individuals more than 95% of the time, a decreased response has been noted in specific pediatric populations, including those with inflammatory and autoimmune diseases. “This is important to note and investigate further because a decreased vaccine response increases the risk for this high-risk population, and the use of boosters is currently debated,” said Ms. Ritter, who is a fourth-year student at the Medical University of South Carolina, Charleston.
To determine the percent of pediatric patients with inflammatory or autoimmune disease who lack evidence of immunity following the hepatitis B vaccine series, Ms. Ritter and colleagues Abigail Truitt and pediatric dermatologist Lara Wine Lee, MD, PhD, of MUSC, retrospectively reviewed the charts of 160 patients between the ages of 6 months and 21 years, who were diagnosed with an autoimmune or autoinflammatory disease, or inflammatory bowel disease (IBD), and had documented evidence of vaccination and serologic testing prior to the start of immunosuppressive therapy.
Of the 160 patients, 100 (63%) had IBD, 34 (21%) had an autoimmune disease, 26 (16%) had an autoinflammatory disease, 89 (56%) were female, and their mean age was 15 years.
The researchers observed variation in the testing ordered between the three patient groups. Specifically, 88.2% of autoimmune patients had hepatitis B surface antigen (HBsAg) testing, compared with 96.15% of patients with an autoinflammatory disease and 67% of patients with IBD, while 76.47% of patients with an autoimmune disease had hepatitis B core antibody (anti-HBc) testing, compared with 88.46% of patients with an autoinflammatory disease and 31% of patients with IBD.
In addition, 82.35% of patients with an autoimmune disease had HBsAg testing, compared with 100% of patients with an autoinflammatory disease and 94% of patients with IBD.
Of the 148 patients who had HBsAg testing ordered and completed prior to starting an immunosuppressive drug, there was no statistically significant difference in the percent of patients showing evidence of an immune response to the hepatitis B vaccine (32.14% among patients with an autoimmune disease, 34.62% among patients with an autoinflammatory disease, and 31.91% among patients with IBD). Combined, 67.57% of tested negative for the hepatitis B surface antibody.
“Our study showed that the majority of these patients did not show serologic evidence of immunity despite being fully vaccinated,” Ms. Ritter said. “There was also variation in the testing ordered and a more standardized approach is needed in this high-risk population.” She acknowledged certain limitations of the study, including its retrospective design and lack of a control group.
“This brings us to our next question of whether this indicates a failure of the vaccine, or the way immunity is tested,” she continued. “The CDC and the European Consensus Group on Hepatitis B Immunity recommend a cutoff of greater than 10 mIU/mL. Those that achieve immunity are protected for up to 20 years due to immune memory, even if their antibody levels later drop. There have been rare cases of immunocompetent individuals having evidence of transient asymptomatic infections when antibody levels drop. The chronic disease has only been documented in infants born to positive mothers. In hemodialysis patients, however, clinically significant infections have been documented when antibody levels drop.”
The CDC only recommends postvaccination testing to infants born to positive mothers, health care workers at high risk, hemodialysis patients, people with HIV and other immunocompromised people, and needle-sharing partners of chronically infected people. This is completed 1-2 months following the third vaccine dose, and those with antibody levels less than 10 mIU/mL should be revaccinated. “As some groups do not respond to the vaccine series, alternative dosing and the intradermal vaccine have been studied and shown to be effective in certain groups,” she said.
When it comes to monitoring immunocompromised individuals and giving booster shots, however, there are conflicting recommendations. The CDC recommends yearly testing and booster shots when levels drop below 10 mIU/mL only in hemodialysis patients, while the European Consensus Group recommends testing every 6-12 months for immunocompromised individuals and boosters when their levels drop below 10 mIU/mL.
“The CDC has not yet determined if other immunocompromised individuals should receive a booster, with more research required, but studies have shown it to be effective,” Ms. Ritter said. In a similar study looking at evidence of immunity in children with connective tissue disease who were on immunosuppressive treatment, 50% had no evidence of protective antibodies, compared with 96% in the control group. “In that study, a booster shot was given, and protective antibody concentrations were found at follow-up,” she said.
The researchers reported having no financial disclosures.
[email protected]
FROM SPD 2021
Febrile infant guideline allows wiggle room on hospital admission, testing
The long-anticipated American Academy of Pediatrics guidelines for the treatment of well-appearing febrile infants have arrived, and key points include updated guidance for cerebrospinal fluid testing and urine cultures, according to Robert Pantell, MD, and Kenneth Roberts, MD, who presented the guidelines at the virtual Pediatric Hospital Medicine annual conference.
The AAP guideline was published in the August 2021 issue of Pediatrics. The guideline includes 21 key action statements and 40 total recommendations, and describes separate management algorithms for three age groups: infants aged 8-21 days, 22-28 days, and 29-60 days.
Dr. Roberts, of the University of North Carolina at Chapel Hill, and Dr. Pantell, of the University of California, San Francisco, emphasized that all pediatricians should read the full guideline, but they offered an overview of some of the notable points.
Some changes that drove the development of evidence-based guideline included changes in technology, such as the increased use of procalcitonin, the development of large research networks for studies of sufficient size, and a need to reduce the costs of unnecessary care and unnecessary trauma for infants, Dr. Roberts said. Use of data from large networks such as the Pediatric Emergency Care Applied Research Network provided enough evidence to support dividing the aged 8- to 60-day population into three groups.
The guideline applies to well-appearing term infants aged 8-60 days and at least 37 weeks’ gestation, with fever of 38° C (100.4° F) or higher in the past 24 hours in the home or clinical setting. The decision to exclude infants in the first week of life from the guideline was because at this age, infants “are sufficiently different in rates and types of illness, including early-onset bacterial infection,” according to the authors.
Dr. Roberts emphasized that the guidelines apply to “well-appearing infants,” which is not always obvious. “If a clinician is not confident an infant is well appearing, the clinical practice guideline should not be applied,” he said.
The guideline also includes a visual algorithm for each age group.
Dr. Pantell summarized the key action statements for the three age groups, and encouraged pediatricians to review the visual algorithms and footnotes available in the full text of the guideline.
The guideline includes seven key action statements for each of the three age groups. Four of these address evaluations, using urine, blood culture, inflammatory markers (IM), and cerebrospinal fluid (CSF). One action statement focuses on initial treatment, and two on management: hospital admission versus monitoring at home, and treatment cessation.
Infants aged 8-21 days
The key action statements for well-appearing infants aged 8-21 days are similar to what clinicians likely would do for ill-appearing infants, the authors noted, based in part on the challenge of assessing an infant this age as “well appearing,” because they don’t yet have the ability to interact with the clinician.
For the 8- to 21-day group, the first two key actions are to obtain a urine specimen and blood culture, Dr. Pantell said. Also, clinicians “should” obtain a CSF for analysis and culture. “We recognize that the ability to get CSF quickly is a challenge,” he added. However, for the 8- to 21-day age group, a new feature is that these infants may be discharged if the CSF is negative. Evaluation in this youngest group states that clinicians “may assess inflammatory markers” including height of fever, absolute neutrophil count, C-reactive protein, and procalcitonin.
Treatment of infants in the 8- to 21-day group “should” include parenteral antimicrobial therapy, according to the guideline, and these infants “should” be actively monitored in the hospital by nurses and staff experienced in neonatal care, Dr. Pantell said. The guideline also includes a key action statement to stop antimicrobials at 24-36 hours if cultures are negative, but to treat identified organisms.
Infants aged 22-28 days
In both the 22- to 28-day-old and 29- to 60-day-old groups, the guideline offers opportunities for less testing and treatment, such as avoiding a lumbar puncture, and fewer hospitalizations. The development of a separate guideline for the 22- to 28-day group is something new, said Dr. Pantell. The guideline states that clinicians should obtain urine specimens and blood culture, and should assess IM in this group. Further key action statements note that clinicians “should obtain a CSF if any IM is positive,” but “may” obtain CSF if the infant is hospitalized, if blood and urine cultures have been obtained, and if none of the IMs are abnormal.
As with younger patients, those with a negative CSF can go home, he said. As for treatment, clinicians “should” administer parenteral antimicrobial therapy to infants managed at home even if they have a negative CSF and urinalysis (UA), and no abnormal inflammatory markers Other points for management of infants in this age group at home include verbal teaching and written instructions for caregivers, plans for a re-evaluation at home in 24 hours, and a plan for communication and access to emergency care in case of a change in clinical status, Dr. Pantell explained. The guideline states that infants “should” be hospitalized if CSF is either not obtained or not interpretable, which leaves room for clinical judgment and individual circumstances. Antimicrobials “should” be discontinued in this group once all cultures are negative after 24-36 hours and no other infection requires treatment.
Infants aged 29-60 days
For the 29- to 60-day group, there are some differences, the main one is the recommendation of blood cultures in this group, said Dr. Pantell. “We are seeing a lot of UTIs [urinary tract infections], and we would like those treated.” However, clinicians need not obtain a CSF if other IMs are normal, but may do so if any IM is abnormal. Antimicrobial therapy may include ceftriaxone or cephalexin for UTIs, or vancomycin for bacteremia.
Although antimicrobial therapy is an option for UTIs and bacterial meningitis, clinicians “need not” use antimicrobials if CSF is normal, if UA is negative, and if no IMs are abnormal, Dr. Pantell added. Overall, further management of infants in this oldest age group should focus on discharge to home in the absence of abnormal findings, but hospitalization in the presence of abnormal CSF, IMs, or other concerns.
During a question-and-answer session, Dr. Roberts said that, while rectal temperature is preferable, any method is acceptable as a starting point for applying the guideline. Importantly, the guideline still leaves room for clinical judgment. “We hope this will change some thinking as far as whether one model fits all,” he noted. The authors tried to temper the word “should” with the word “may” when possible, so clinicians can say: “I’m going to individualize my decision to the infant in front of me.”
Ultimately, the guideline is meant as a guide, and not an absolute standard of care, the authors said. The language of the key action statements includes the words “should, may, need not” in place of “must, must not.” The guideline recommends factoring family values and preferences into any treatment decisions. “Variations, taking into account individual circumstances, may be appropriate.”
The guideline received no outside funding. The authors had no financial conflicts to disclose.
The long-anticipated American Academy of Pediatrics guidelines for the treatment of well-appearing febrile infants have arrived, and key points include updated guidance for cerebrospinal fluid testing and urine cultures, according to Robert Pantell, MD, and Kenneth Roberts, MD, who presented the guidelines at the virtual Pediatric Hospital Medicine annual conference.
The AAP guideline was published in the August 2021 issue of Pediatrics. The guideline includes 21 key action statements and 40 total recommendations, and describes separate management algorithms for three age groups: infants aged 8-21 days, 22-28 days, and 29-60 days.
Dr. Roberts, of the University of North Carolina at Chapel Hill, and Dr. Pantell, of the University of California, San Francisco, emphasized that all pediatricians should read the full guideline, but they offered an overview of some of the notable points.
Some changes that drove the development of evidence-based guideline included changes in technology, such as the increased use of procalcitonin, the development of large research networks for studies of sufficient size, and a need to reduce the costs of unnecessary care and unnecessary trauma for infants, Dr. Roberts said. Use of data from large networks such as the Pediatric Emergency Care Applied Research Network provided enough evidence to support dividing the aged 8- to 60-day population into three groups.
The guideline applies to well-appearing term infants aged 8-60 days and at least 37 weeks’ gestation, with fever of 38° C (100.4° F) or higher in the past 24 hours in the home or clinical setting. The decision to exclude infants in the first week of life from the guideline was because at this age, infants “are sufficiently different in rates and types of illness, including early-onset bacterial infection,” according to the authors.
Dr. Roberts emphasized that the guidelines apply to “well-appearing infants,” which is not always obvious. “If a clinician is not confident an infant is well appearing, the clinical practice guideline should not be applied,” he said.
The guideline also includes a visual algorithm for each age group.
Dr. Pantell summarized the key action statements for the three age groups, and encouraged pediatricians to review the visual algorithms and footnotes available in the full text of the guideline.
The guideline includes seven key action statements for each of the three age groups. Four of these address evaluations, using urine, blood culture, inflammatory markers (IM), and cerebrospinal fluid (CSF). One action statement focuses on initial treatment, and two on management: hospital admission versus monitoring at home, and treatment cessation.
Infants aged 8-21 days
The key action statements for well-appearing infants aged 8-21 days are similar to what clinicians likely would do for ill-appearing infants, the authors noted, based in part on the challenge of assessing an infant this age as “well appearing,” because they don’t yet have the ability to interact with the clinician.
For the 8- to 21-day group, the first two key actions are to obtain a urine specimen and blood culture, Dr. Pantell said. Also, clinicians “should” obtain a CSF for analysis and culture. “We recognize that the ability to get CSF quickly is a challenge,” he added. However, for the 8- to 21-day age group, a new feature is that these infants may be discharged if the CSF is negative. Evaluation in this youngest group states that clinicians “may assess inflammatory markers” including height of fever, absolute neutrophil count, C-reactive protein, and procalcitonin.
Treatment of infants in the 8- to 21-day group “should” include parenteral antimicrobial therapy, according to the guideline, and these infants “should” be actively monitored in the hospital by nurses and staff experienced in neonatal care, Dr. Pantell said. The guideline also includes a key action statement to stop antimicrobials at 24-36 hours if cultures are negative, but to treat identified organisms.
Infants aged 22-28 days
In both the 22- to 28-day-old and 29- to 60-day-old groups, the guideline offers opportunities for less testing and treatment, such as avoiding a lumbar puncture, and fewer hospitalizations. The development of a separate guideline for the 22- to 28-day group is something new, said Dr. Pantell. The guideline states that clinicians should obtain urine specimens and blood culture, and should assess IM in this group. Further key action statements note that clinicians “should obtain a CSF if any IM is positive,” but “may” obtain CSF if the infant is hospitalized, if blood and urine cultures have been obtained, and if none of the IMs are abnormal.
As with younger patients, those with a negative CSF can go home, he said. As for treatment, clinicians “should” administer parenteral antimicrobial therapy to infants managed at home even if they have a negative CSF and urinalysis (UA), and no abnormal inflammatory markers Other points for management of infants in this age group at home include verbal teaching and written instructions for caregivers, plans for a re-evaluation at home in 24 hours, and a plan for communication and access to emergency care in case of a change in clinical status, Dr. Pantell explained. The guideline states that infants “should” be hospitalized if CSF is either not obtained or not interpretable, which leaves room for clinical judgment and individual circumstances. Antimicrobials “should” be discontinued in this group once all cultures are negative after 24-36 hours and no other infection requires treatment.
Infants aged 29-60 days
For the 29- to 60-day group, there are some differences, the main one is the recommendation of blood cultures in this group, said Dr. Pantell. “We are seeing a lot of UTIs [urinary tract infections], and we would like those treated.” However, clinicians need not obtain a CSF if other IMs are normal, but may do so if any IM is abnormal. Antimicrobial therapy may include ceftriaxone or cephalexin for UTIs, or vancomycin for bacteremia.
Although antimicrobial therapy is an option for UTIs and bacterial meningitis, clinicians “need not” use antimicrobials if CSF is normal, if UA is negative, and if no IMs are abnormal, Dr. Pantell added. Overall, further management of infants in this oldest age group should focus on discharge to home in the absence of abnormal findings, but hospitalization in the presence of abnormal CSF, IMs, or other concerns.
During a question-and-answer session, Dr. Roberts said that, while rectal temperature is preferable, any method is acceptable as a starting point for applying the guideline. Importantly, the guideline still leaves room for clinical judgment. “We hope this will change some thinking as far as whether one model fits all,” he noted. The authors tried to temper the word “should” with the word “may” when possible, so clinicians can say: “I’m going to individualize my decision to the infant in front of me.”
Ultimately, the guideline is meant as a guide, and not an absolute standard of care, the authors said. The language of the key action statements includes the words “should, may, need not” in place of “must, must not.” The guideline recommends factoring family values and preferences into any treatment decisions. “Variations, taking into account individual circumstances, may be appropriate.”
The guideline received no outside funding. The authors had no financial conflicts to disclose.
The long-anticipated American Academy of Pediatrics guidelines for the treatment of well-appearing febrile infants have arrived, and key points include updated guidance for cerebrospinal fluid testing and urine cultures, according to Robert Pantell, MD, and Kenneth Roberts, MD, who presented the guidelines at the virtual Pediatric Hospital Medicine annual conference.
The AAP guideline was published in the August 2021 issue of Pediatrics. The guideline includes 21 key action statements and 40 total recommendations, and describes separate management algorithms for three age groups: infants aged 8-21 days, 22-28 days, and 29-60 days.
Dr. Roberts, of the University of North Carolina at Chapel Hill, and Dr. Pantell, of the University of California, San Francisco, emphasized that all pediatricians should read the full guideline, but they offered an overview of some of the notable points.
Some changes that drove the development of evidence-based guideline included changes in technology, such as the increased use of procalcitonin, the development of large research networks for studies of sufficient size, and a need to reduce the costs of unnecessary care and unnecessary trauma for infants, Dr. Roberts said. Use of data from large networks such as the Pediatric Emergency Care Applied Research Network provided enough evidence to support dividing the aged 8- to 60-day population into three groups.
The guideline applies to well-appearing term infants aged 8-60 days and at least 37 weeks’ gestation, with fever of 38° C (100.4° F) or higher in the past 24 hours in the home or clinical setting. The decision to exclude infants in the first week of life from the guideline was because at this age, infants “are sufficiently different in rates and types of illness, including early-onset bacterial infection,” according to the authors.
Dr. Roberts emphasized that the guidelines apply to “well-appearing infants,” which is not always obvious. “If a clinician is not confident an infant is well appearing, the clinical practice guideline should not be applied,” he said.
The guideline also includes a visual algorithm for each age group.
Dr. Pantell summarized the key action statements for the three age groups, and encouraged pediatricians to review the visual algorithms and footnotes available in the full text of the guideline.
The guideline includes seven key action statements for each of the three age groups. Four of these address evaluations, using urine, blood culture, inflammatory markers (IM), and cerebrospinal fluid (CSF). One action statement focuses on initial treatment, and two on management: hospital admission versus monitoring at home, and treatment cessation.
Infants aged 8-21 days
The key action statements for well-appearing infants aged 8-21 days are similar to what clinicians likely would do for ill-appearing infants, the authors noted, based in part on the challenge of assessing an infant this age as “well appearing,” because they don’t yet have the ability to interact with the clinician.
For the 8- to 21-day group, the first two key actions are to obtain a urine specimen and blood culture, Dr. Pantell said. Also, clinicians “should” obtain a CSF for analysis and culture. “We recognize that the ability to get CSF quickly is a challenge,” he added. However, for the 8- to 21-day age group, a new feature is that these infants may be discharged if the CSF is negative. Evaluation in this youngest group states that clinicians “may assess inflammatory markers” including height of fever, absolute neutrophil count, C-reactive protein, and procalcitonin.
Treatment of infants in the 8- to 21-day group “should” include parenteral antimicrobial therapy, according to the guideline, and these infants “should” be actively monitored in the hospital by nurses and staff experienced in neonatal care, Dr. Pantell said. The guideline also includes a key action statement to stop antimicrobials at 24-36 hours if cultures are negative, but to treat identified organisms.
Infants aged 22-28 days
In both the 22- to 28-day-old and 29- to 60-day-old groups, the guideline offers opportunities for less testing and treatment, such as avoiding a lumbar puncture, and fewer hospitalizations. The development of a separate guideline for the 22- to 28-day group is something new, said Dr. Pantell. The guideline states that clinicians should obtain urine specimens and blood culture, and should assess IM in this group. Further key action statements note that clinicians “should obtain a CSF if any IM is positive,” but “may” obtain CSF if the infant is hospitalized, if blood and urine cultures have been obtained, and if none of the IMs are abnormal.
As with younger patients, those with a negative CSF can go home, he said. As for treatment, clinicians “should” administer parenteral antimicrobial therapy to infants managed at home even if they have a negative CSF and urinalysis (UA), and no abnormal inflammatory markers Other points for management of infants in this age group at home include verbal teaching and written instructions for caregivers, plans for a re-evaluation at home in 24 hours, and a plan for communication and access to emergency care in case of a change in clinical status, Dr. Pantell explained. The guideline states that infants “should” be hospitalized if CSF is either not obtained or not interpretable, which leaves room for clinical judgment and individual circumstances. Antimicrobials “should” be discontinued in this group once all cultures are negative after 24-36 hours and no other infection requires treatment.
Infants aged 29-60 days
For the 29- to 60-day group, there are some differences, the main one is the recommendation of blood cultures in this group, said Dr. Pantell. “We are seeing a lot of UTIs [urinary tract infections], and we would like those treated.” However, clinicians need not obtain a CSF if other IMs are normal, but may do so if any IM is abnormal. Antimicrobial therapy may include ceftriaxone or cephalexin for UTIs, or vancomycin for bacteremia.
Although antimicrobial therapy is an option for UTIs and bacterial meningitis, clinicians “need not” use antimicrobials if CSF is normal, if UA is negative, and if no IMs are abnormal, Dr. Pantell added. Overall, further management of infants in this oldest age group should focus on discharge to home in the absence of abnormal findings, but hospitalization in the presence of abnormal CSF, IMs, or other concerns.
During a question-and-answer session, Dr. Roberts said that, while rectal temperature is preferable, any method is acceptable as a starting point for applying the guideline. Importantly, the guideline still leaves room for clinical judgment. “We hope this will change some thinking as far as whether one model fits all,” he noted. The authors tried to temper the word “should” with the word “may” when possible, so clinicians can say: “I’m going to individualize my decision to the infant in front of me.”
Ultimately, the guideline is meant as a guide, and not an absolute standard of care, the authors said. The language of the key action statements includes the words “should, may, need not” in place of “must, must not.” The guideline recommends factoring family values and preferences into any treatment decisions. “Variations, taking into account individual circumstances, may be appropriate.”
The guideline received no outside funding. The authors had no financial conflicts to disclose.
FROM PHM 2021
CAR T-cell therapy drives refractory SLE into remission
Chimeric antigen receptor T-cell (CAR T) therapy, a life-extending treatment for patients with advanced B-cell malignancies and multiple myeloma, has now been shown to be effective for treating refractory systemic lupus erythematosus (SLE) in at least one patient.
A 20-year-old woman with severe, refractory SLE, active lupus nephritis, pericarditis, and other serious symptoms had both serologic and clinical remission follow the infusion of a CAR T cell product directed against the B-cell surface antigen CD19, reported Georg Schett, MD, and colleagues from the German Center for Immunotherapy at Friedrich Alexander University Erlangen-Nuremberg in Erlangen, Germany.
“Given the role of B cells in a variety of severe autoimmune diseases, CAR T-cell therapy that targets B-cell antigens may have wider application,” they wrote in a letter to the editor of The New England Journal of Medicine.
Dr. Schett said in an email response to an interview request that the patient has remained healthy and asymptomatic without further treatment after 6 months of follow-up.
“The key question will be whether B cells return and whether these B cells will carry on to make antibodies against double-stranded DNA,” he said. “We think that the loss of B cells could be sustained given that CAR T cells are still present in the patient. The main question will be how long CAR T cells will be there and how long they deplete the B cells.”
Not just for cancer anymore
CAR T therapy involves harvesting autologous T cells and transducing them with a lentiviral vector to recognize CD19 or other B-cell surface antigens. The transduced cells are then expanded and reinfused into the patient following a lymphodepletion regimen.
There are currently five CAR T constructs approved by the Food and Drug Administration for the treatment of diffuse large B-cell lymphoma and other B-lineage lymphomas, acute lymphoblastic leukemia, multiple myeloma, and other hematologic malignancies.
For this patient, however, Dr. Schett and colleagues created their own CAR T construct rather than adapting an off-the-shelf product.
The use of this groundbreaking therapy to treat an autoimmune condition is novel, the investigators noted: “This technological breakthrough, together with recent convincing data on the role of B cells in disease pathogenesis derived from preclinical lupus models, provides a rationale for the use of CAR T-cell therapies in patients with SLE,” they wrote.
One such preclinical study was reported in Science Translational Medicine in 2019 by Marko Z. Radic, PhD, of the University of Tennessee Health Science Center in Memphis, and colleagues.
Those investigators generated CD19-targeted CAR T constructs and demonstrated that in mouse models of lupus, CD8-positive T cells from two different lupus strains could be successfully transfected, and that transfer of the CD19-targeting CAR T cells ablated both autoantibodies and CD19-positive cells.
“In both models, survival was remarkably extended, and target organs were spared. These exciting results could pave the way for using CD19-targeted T cells to treat patients with lupus,” they wrote.
Now, that prediction has come to fruition.
“It’s brilliant that the first case report has now been accomplished. I am fully convinced that this method will rid therapy refractory patients of their symptoms,” Dr. Radic said in an interview.
Anti-CD20 failures
B-cell depletion with the anti-CD20 monoclonal antibody rituximab has been shown to be an effective therapeutic strategy for patients with rheumatoid arthritis and multiple sclerosis, but was ineffective in two separate clinical trials for SLE.
“Incomplete B-cell depletion of tissue-resident B cells, or the transient nature of the treatment, may have contributed to the failure of the initial rituximab trials to attain satisfactory outcomes,” Dr. Radic and coauthors wrote.
In patients with severe lupus, autoreactive B cells may lurk in lymphatic organs and/or inflamed tissues. Alternatively, CD20-negative plasma cells, which are unaffected by rituximab, could also be a source of SLE autoantibodies, Dr. Schett and coinvestigators said.
Case details
As noted before, the 20-year-old patient described by Dr. Schett and colleagues presented with World Health Organization class IIIA active lupus nephritis, indicating focal proliferative disease. In addition, she also had nephritic syndrome, pericarditis, pleurisy, rash, and arthritis, and had a history of Libman-Sacks endocarditis.
Her disease was refractory to treatment with all the usual suspects, including hydroxychloroquine, high-dose glucocorticoids, cyclophosphamide, mycophenolate mofetil, tacrolimus, rituximab, and belimumab, another B-cell targeted agent.
The T cell collection, transduction, expansion, and infusion were all successfully performed. By day 9 following infusion, CAR T cells comprised nearly one-third of her total circulating T cells, and then began to decrease, but remained detectable in circulation for the ensuing 7 weeks.
Levels of anti–double-stranded DNA decreased from above 5,000 U/mL to 4 U/mL within 5 weeks, and her complement levels (C3 and C4) normalized.
“These signs of serologic remission were paralleled by clinical remission with proteinuria decreasing from above 2,000 mg of protein per gram of creatinine to less than 250 mg of protein per gram of creatinine,” the investigators wrote.
The patient’s SLE Disease Activity Index score with SELENA (Safety of Estrogens in Lupus National Assessment) modification dropped from 16 at baseline to 0 at follow-up.
The patient did not experience any of the adverse events that are commonly seen in patients treated with CAR T therapy, such as the cytokine release syndrome, neurotoxic adverse events, or prolonged cytopenias.
Unanswered questions
Dr. Radic said that it was unclear from the brief case report whether Dr. Schett and colleagues considered including a “kill switch” in their CAR T construct, which could be activated in the case of serious toxicities.
In addition, their use of both CD4-positive T cells in addition to CD8-positive cells in their construct raises some concern, because in patients with SLE there is evidence that CD4-positive helper T cells can be autoreactive, he noted.
The work by Dr. Schett and colleagues was supported by grants from the German government, European Union, and the Innovative Medicines Initiative. Dr. Schett reported having no conflicts of interest to disclose. Dr. Radic is listed as inventor on a patent for anti-CD19 CAR T cells in lupus.
Chimeric antigen receptor T-cell (CAR T) therapy, a life-extending treatment for patients with advanced B-cell malignancies and multiple myeloma, has now been shown to be effective for treating refractory systemic lupus erythematosus (SLE) in at least one patient.
A 20-year-old woman with severe, refractory SLE, active lupus nephritis, pericarditis, and other serious symptoms had both serologic and clinical remission follow the infusion of a CAR T cell product directed against the B-cell surface antigen CD19, reported Georg Schett, MD, and colleagues from the German Center for Immunotherapy at Friedrich Alexander University Erlangen-Nuremberg in Erlangen, Germany.
“Given the role of B cells in a variety of severe autoimmune diseases, CAR T-cell therapy that targets B-cell antigens may have wider application,” they wrote in a letter to the editor of The New England Journal of Medicine.
Dr. Schett said in an email response to an interview request that the patient has remained healthy and asymptomatic without further treatment after 6 months of follow-up.
“The key question will be whether B cells return and whether these B cells will carry on to make antibodies against double-stranded DNA,” he said. “We think that the loss of B cells could be sustained given that CAR T cells are still present in the patient. The main question will be how long CAR T cells will be there and how long they deplete the B cells.”
Not just for cancer anymore
CAR T therapy involves harvesting autologous T cells and transducing them with a lentiviral vector to recognize CD19 or other B-cell surface antigens. The transduced cells are then expanded and reinfused into the patient following a lymphodepletion regimen.
There are currently five CAR T constructs approved by the Food and Drug Administration for the treatment of diffuse large B-cell lymphoma and other B-lineage lymphomas, acute lymphoblastic leukemia, multiple myeloma, and other hematologic malignancies.
For this patient, however, Dr. Schett and colleagues created their own CAR T construct rather than adapting an off-the-shelf product.
The use of this groundbreaking therapy to treat an autoimmune condition is novel, the investigators noted: “This technological breakthrough, together with recent convincing data on the role of B cells in disease pathogenesis derived from preclinical lupus models, provides a rationale for the use of CAR T-cell therapies in patients with SLE,” they wrote.
One such preclinical study was reported in Science Translational Medicine in 2019 by Marko Z. Radic, PhD, of the University of Tennessee Health Science Center in Memphis, and colleagues.
Those investigators generated CD19-targeted CAR T constructs and demonstrated that in mouse models of lupus, CD8-positive T cells from two different lupus strains could be successfully transfected, and that transfer of the CD19-targeting CAR T cells ablated both autoantibodies and CD19-positive cells.
“In both models, survival was remarkably extended, and target organs were spared. These exciting results could pave the way for using CD19-targeted T cells to treat patients with lupus,” they wrote.
Now, that prediction has come to fruition.
“It’s brilliant that the first case report has now been accomplished. I am fully convinced that this method will rid therapy refractory patients of their symptoms,” Dr. Radic said in an interview.
Anti-CD20 failures
B-cell depletion with the anti-CD20 monoclonal antibody rituximab has been shown to be an effective therapeutic strategy for patients with rheumatoid arthritis and multiple sclerosis, but was ineffective in two separate clinical trials for SLE.
“Incomplete B-cell depletion of tissue-resident B cells, or the transient nature of the treatment, may have contributed to the failure of the initial rituximab trials to attain satisfactory outcomes,” Dr. Radic and coauthors wrote.
In patients with severe lupus, autoreactive B cells may lurk in lymphatic organs and/or inflamed tissues. Alternatively, CD20-negative plasma cells, which are unaffected by rituximab, could also be a source of SLE autoantibodies, Dr. Schett and coinvestigators said.
Case details
As noted before, the 20-year-old patient described by Dr. Schett and colleagues presented with World Health Organization class IIIA active lupus nephritis, indicating focal proliferative disease. In addition, she also had nephritic syndrome, pericarditis, pleurisy, rash, and arthritis, and had a history of Libman-Sacks endocarditis.
Her disease was refractory to treatment with all the usual suspects, including hydroxychloroquine, high-dose glucocorticoids, cyclophosphamide, mycophenolate mofetil, tacrolimus, rituximab, and belimumab, another B-cell targeted agent.
The T cell collection, transduction, expansion, and infusion were all successfully performed. By day 9 following infusion, CAR T cells comprised nearly one-third of her total circulating T cells, and then began to decrease, but remained detectable in circulation for the ensuing 7 weeks.
Levels of anti–double-stranded DNA decreased from above 5,000 U/mL to 4 U/mL within 5 weeks, and her complement levels (C3 and C4) normalized.
“These signs of serologic remission were paralleled by clinical remission with proteinuria decreasing from above 2,000 mg of protein per gram of creatinine to less than 250 mg of protein per gram of creatinine,” the investigators wrote.
The patient’s SLE Disease Activity Index score with SELENA (Safety of Estrogens in Lupus National Assessment) modification dropped from 16 at baseline to 0 at follow-up.
The patient did not experience any of the adverse events that are commonly seen in patients treated with CAR T therapy, such as the cytokine release syndrome, neurotoxic adverse events, or prolonged cytopenias.
Unanswered questions
Dr. Radic said that it was unclear from the brief case report whether Dr. Schett and colleagues considered including a “kill switch” in their CAR T construct, which could be activated in the case of serious toxicities.
In addition, their use of both CD4-positive T cells in addition to CD8-positive cells in their construct raises some concern, because in patients with SLE there is evidence that CD4-positive helper T cells can be autoreactive, he noted.
The work by Dr. Schett and colleagues was supported by grants from the German government, European Union, and the Innovative Medicines Initiative. Dr. Schett reported having no conflicts of interest to disclose. Dr. Radic is listed as inventor on a patent for anti-CD19 CAR T cells in lupus.
Chimeric antigen receptor T-cell (CAR T) therapy, a life-extending treatment for patients with advanced B-cell malignancies and multiple myeloma, has now been shown to be effective for treating refractory systemic lupus erythematosus (SLE) in at least one patient.
A 20-year-old woman with severe, refractory SLE, active lupus nephritis, pericarditis, and other serious symptoms had both serologic and clinical remission follow the infusion of a CAR T cell product directed against the B-cell surface antigen CD19, reported Georg Schett, MD, and colleagues from the German Center for Immunotherapy at Friedrich Alexander University Erlangen-Nuremberg in Erlangen, Germany.
“Given the role of B cells in a variety of severe autoimmune diseases, CAR T-cell therapy that targets B-cell antigens may have wider application,” they wrote in a letter to the editor of The New England Journal of Medicine.
Dr. Schett said in an email response to an interview request that the patient has remained healthy and asymptomatic without further treatment after 6 months of follow-up.
“The key question will be whether B cells return and whether these B cells will carry on to make antibodies against double-stranded DNA,” he said. “We think that the loss of B cells could be sustained given that CAR T cells are still present in the patient. The main question will be how long CAR T cells will be there and how long they deplete the B cells.”
Not just for cancer anymore
CAR T therapy involves harvesting autologous T cells and transducing them with a lentiviral vector to recognize CD19 or other B-cell surface antigens. The transduced cells are then expanded and reinfused into the patient following a lymphodepletion regimen.
There are currently five CAR T constructs approved by the Food and Drug Administration for the treatment of diffuse large B-cell lymphoma and other B-lineage lymphomas, acute lymphoblastic leukemia, multiple myeloma, and other hematologic malignancies.
For this patient, however, Dr. Schett and colleagues created their own CAR T construct rather than adapting an off-the-shelf product.
The use of this groundbreaking therapy to treat an autoimmune condition is novel, the investigators noted: “This technological breakthrough, together with recent convincing data on the role of B cells in disease pathogenesis derived from preclinical lupus models, provides a rationale for the use of CAR T-cell therapies in patients with SLE,” they wrote.
One such preclinical study was reported in Science Translational Medicine in 2019 by Marko Z. Radic, PhD, of the University of Tennessee Health Science Center in Memphis, and colleagues.
Those investigators generated CD19-targeted CAR T constructs and demonstrated that in mouse models of lupus, CD8-positive T cells from two different lupus strains could be successfully transfected, and that transfer of the CD19-targeting CAR T cells ablated both autoantibodies and CD19-positive cells.
“In both models, survival was remarkably extended, and target organs were spared. These exciting results could pave the way for using CD19-targeted T cells to treat patients with lupus,” they wrote.
Now, that prediction has come to fruition.
“It’s brilliant that the first case report has now been accomplished. I am fully convinced that this method will rid therapy refractory patients of their symptoms,” Dr. Radic said in an interview.
Anti-CD20 failures
B-cell depletion with the anti-CD20 monoclonal antibody rituximab has been shown to be an effective therapeutic strategy for patients with rheumatoid arthritis and multiple sclerosis, but was ineffective in two separate clinical trials for SLE.
“Incomplete B-cell depletion of tissue-resident B cells, or the transient nature of the treatment, may have contributed to the failure of the initial rituximab trials to attain satisfactory outcomes,” Dr. Radic and coauthors wrote.
In patients with severe lupus, autoreactive B cells may lurk in lymphatic organs and/or inflamed tissues. Alternatively, CD20-negative plasma cells, which are unaffected by rituximab, could also be a source of SLE autoantibodies, Dr. Schett and coinvestigators said.
Case details
As noted before, the 20-year-old patient described by Dr. Schett and colleagues presented with World Health Organization class IIIA active lupus nephritis, indicating focal proliferative disease. In addition, she also had nephritic syndrome, pericarditis, pleurisy, rash, and arthritis, and had a history of Libman-Sacks endocarditis.
Her disease was refractory to treatment with all the usual suspects, including hydroxychloroquine, high-dose glucocorticoids, cyclophosphamide, mycophenolate mofetil, tacrolimus, rituximab, and belimumab, another B-cell targeted agent.
The T cell collection, transduction, expansion, and infusion were all successfully performed. By day 9 following infusion, CAR T cells comprised nearly one-third of her total circulating T cells, and then began to decrease, but remained detectable in circulation for the ensuing 7 weeks.
Levels of anti–double-stranded DNA decreased from above 5,000 U/mL to 4 U/mL within 5 weeks, and her complement levels (C3 and C4) normalized.
“These signs of serologic remission were paralleled by clinical remission with proteinuria decreasing from above 2,000 mg of protein per gram of creatinine to less than 250 mg of protein per gram of creatinine,” the investigators wrote.
The patient’s SLE Disease Activity Index score with SELENA (Safety of Estrogens in Lupus National Assessment) modification dropped from 16 at baseline to 0 at follow-up.
The patient did not experience any of the adverse events that are commonly seen in patients treated with CAR T therapy, such as the cytokine release syndrome, neurotoxic adverse events, or prolonged cytopenias.
Unanswered questions
Dr. Radic said that it was unclear from the brief case report whether Dr. Schett and colleagues considered including a “kill switch” in their CAR T construct, which could be activated in the case of serious toxicities.
In addition, their use of both CD4-positive T cells in addition to CD8-positive cells in their construct raises some concern, because in patients with SLE there is evidence that CD4-positive helper T cells can be autoreactive, he noted.
The work by Dr. Schett and colleagues was supported by grants from the German government, European Union, and the Innovative Medicines Initiative. Dr. Schett reported having no conflicts of interest to disclose. Dr. Radic is listed as inventor on a patent for anti-CD19 CAR T cells in lupus.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Age, distance from dermatology clinic <p>predict number of melanomas diagnosed
Among patients from a single dermatology practice who were diagnosed with two or more melanomas over an 8-year period, 45% lived more than 20 miles away from the practice, and almost 60% were 70 years of age and older, results from single-center study showed.
“Dermatologists have known that many people are underdiagnosed for melanoma, but now our research supports that the problem is especially concentrated among older patients living in remote areas,” corresponding author Rose Parisi, MBA, said in an interview. “With this information, dermatologists should consider identifying and reaching out to their patients in this at-risk subpopulation, increasing the frequency of full-body skin exams, and collaborating with primary care physicians to educate them about melanoma’s dangers.”
In a study published online Aug. 3 in the Journal of the American Academy of Dermatology, Ms. Parisi of Albany Medical College, New York, and colleagues drew from the electronic medical records of a single-specialty private dermatology practice that serves urban, suburban, and rural patient populations to identify 346 melanoma pathology reports from patients cared for between 2012 and 2020. They limited their investigation to those diagnosed with biopsy-confirmed melanoma and analyzed the number of melanomas, Breslow depth, follow-up full-body skin exams, family history of melanoma, gender, insurance, and age (categorized as younger than 70 years and 70 years or older). To determine patient travel distance, they calculated the miles between the ZIP codes of the patient’s residence and the dermatology practice.
Regression analysis revealed that the . Specifically, among patients diagnosed with two or more melanomas, 45.0% lived more than 20 miles away and 21.3% lived less than 15 miles away; 59.6% were age 70 and older, while 40.4% were younger than age 70 (P less than .01).
No statistically significant association was observed between travel distance and Breslow depth or follow-up full-body skin exams within 1 year following diagnosis.
In other findings, among patients who lived more than 20 miles from the practice, those aged 70 and older were diagnosed with 0.56 more melanomas than patients between the ages of 58 and 70 (P = .00003), and 0.31 more melanomas than patients who lived 15-20 miles away (P = .014). No statistically significant differences in the number of melanomas diagnosed were observed between patients in either age group who lived fewer than 15 miles from the office.
“We were surprised that the combination of age and patient distance to diagnosing dermatology provider was such a powerful predictor of the number of diagnosed melanomas,” Ms. Parisi said. “It’s probably due to less mobility among older patients living in more remote areas, and it puts them at higher risk of multiple melanomas. This was something we haven’t seen in the dermatology literature.”
She and her coauthors acknowledged that the limited sampling of patients from a single practice “may not generalize across all urban and rural settings, and results must be considered preliminary,” they wrote. However, “our findings reveal an important vulnerability among older patients in nonurban areas, and efforts to improve access to melanoma diagnosis should be concentrated on this geodemographic segment.”
Nikolai Klebanov, MD, of the department of dermatology at Massachusetts General Hospital, Boston, who was asked to comment on the study, described what was addressed in the study as a “timely and an important topic.”
In an interview, he said, “there is less access to dermatologists and other medical specialists outside of large metropolitan and suburban areas,” and there are other health disparities affecting people living in rural or more underserved areas, which, he added, “also became exacerbated by the COVID-19 pandemic.”
For future studies on this topic, Dr. Klebanov said that he would be interested to see diagnoses measured per person-year rather than the total number of melanomas diagnosed. “More elderly patients may also be those who have ‘stuck with the practice’ for longer, and had a longer follow-up that gives more time to catch more melanomas,” he said.
“Adjusting for median income using ZIP codes could also help adjust for socioeconomic status, which would help with external validity of the study. Income relationships to geography are not the same in all cities; some have wealthy suburbs within 20 miles, while some have more underserved and rural areas at that distance.”
Neither the researchers nor Dr. Klebanov reported having financial disclosures.
Among patients from a single dermatology practice who were diagnosed with two or more melanomas over an 8-year period, 45% lived more than 20 miles away from the practice, and almost 60% were 70 years of age and older, results from single-center study showed.
“Dermatologists have known that many people are underdiagnosed for melanoma, but now our research supports that the problem is especially concentrated among older patients living in remote areas,” corresponding author Rose Parisi, MBA, said in an interview. “With this information, dermatologists should consider identifying and reaching out to their patients in this at-risk subpopulation, increasing the frequency of full-body skin exams, and collaborating with primary care physicians to educate them about melanoma’s dangers.”
In a study published online Aug. 3 in the Journal of the American Academy of Dermatology, Ms. Parisi of Albany Medical College, New York, and colleagues drew from the electronic medical records of a single-specialty private dermatology practice that serves urban, suburban, and rural patient populations to identify 346 melanoma pathology reports from patients cared for between 2012 and 2020. They limited their investigation to those diagnosed with biopsy-confirmed melanoma and analyzed the number of melanomas, Breslow depth, follow-up full-body skin exams, family history of melanoma, gender, insurance, and age (categorized as younger than 70 years and 70 years or older). To determine patient travel distance, they calculated the miles between the ZIP codes of the patient’s residence and the dermatology practice.
Regression analysis revealed that the . Specifically, among patients diagnosed with two or more melanomas, 45.0% lived more than 20 miles away and 21.3% lived less than 15 miles away; 59.6% were age 70 and older, while 40.4% were younger than age 70 (P less than .01).
No statistically significant association was observed between travel distance and Breslow depth or follow-up full-body skin exams within 1 year following diagnosis.
In other findings, among patients who lived more than 20 miles from the practice, those aged 70 and older were diagnosed with 0.56 more melanomas than patients between the ages of 58 and 70 (P = .00003), and 0.31 more melanomas than patients who lived 15-20 miles away (P = .014). No statistically significant differences in the number of melanomas diagnosed were observed between patients in either age group who lived fewer than 15 miles from the office.
“We were surprised that the combination of age and patient distance to diagnosing dermatology provider was such a powerful predictor of the number of diagnosed melanomas,” Ms. Parisi said. “It’s probably due to less mobility among older patients living in more remote areas, and it puts them at higher risk of multiple melanomas. This was something we haven’t seen in the dermatology literature.”
She and her coauthors acknowledged that the limited sampling of patients from a single practice “may not generalize across all urban and rural settings, and results must be considered preliminary,” they wrote. However, “our findings reveal an important vulnerability among older patients in nonurban areas, and efforts to improve access to melanoma diagnosis should be concentrated on this geodemographic segment.”
Nikolai Klebanov, MD, of the department of dermatology at Massachusetts General Hospital, Boston, who was asked to comment on the study, described what was addressed in the study as a “timely and an important topic.”
In an interview, he said, “there is less access to dermatologists and other medical specialists outside of large metropolitan and suburban areas,” and there are other health disparities affecting people living in rural or more underserved areas, which, he added, “also became exacerbated by the COVID-19 pandemic.”
For future studies on this topic, Dr. Klebanov said that he would be interested to see diagnoses measured per person-year rather than the total number of melanomas diagnosed. “More elderly patients may also be those who have ‘stuck with the practice’ for longer, and had a longer follow-up that gives more time to catch more melanomas,” he said.
“Adjusting for median income using ZIP codes could also help adjust for socioeconomic status, which would help with external validity of the study. Income relationships to geography are not the same in all cities; some have wealthy suburbs within 20 miles, while some have more underserved and rural areas at that distance.”
Neither the researchers nor Dr. Klebanov reported having financial disclosures.
Among patients from a single dermatology practice who were diagnosed with two or more melanomas over an 8-year period, 45% lived more than 20 miles away from the practice, and almost 60% were 70 years of age and older, results from single-center study showed.
“Dermatologists have known that many people are underdiagnosed for melanoma, but now our research supports that the problem is especially concentrated among older patients living in remote areas,” corresponding author Rose Parisi, MBA, said in an interview. “With this information, dermatologists should consider identifying and reaching out to their patients in this at-risk subpopulation, increasing the frequency of full-body skin exams, and collaborating with primary care physicians to educate them about melanoma’s dangers.”
In a study published online Aug. 3 in the Journal of the American Academy of Dermatology, Ms. Parisi of Albany Medical College, New York, and colleagues drew from the electronic medical records of a single-specialty private dermatology practice that serves urban, suburban, and rural patient populations to identify 346 melanoma pathology reports from patients cared for between 2012 and 2020. They limited their investigation to those diagnosed with biopsy-confirmed melanoma and analyzed the number of melanomas, Breslow depth, follow-up full-body skin exams, family history of melanoma, gender, insurance, and age (categorized as younger than 70 years and 70 years or older). To determine patient travel distance, they calculated the miles between the ZIP codes of the patient’s residence and the dermatology practice.
Regression analysis revealed that the . Specifically, among patients diagnosed with two or more melanomas, 45.0% lived more than 20 miles away and 21.3% lived less than 15 miles away; 59.6% were age 70 and older, while 40.4% were younger than age 70 (P less than .01).
No statistically significant association was observed between travel distance and Breslow depth or follow-up full-body skin exams within 1 year following diagnosis.
In other findings, among patients who lived more than 20 miles from the practice, those aged 70 and older were diagnosed with 0.56 more melanomas than patients between the ages of 58 and 70 (P = .00003), and 0.31 more melanomas than patients who lived 15-20 miles away (P = .014). No statistically significant differences in the number of melanomas diagnosed were observed between patients in either age group who lived fewer than 15 miles from the office.
“We were surprised that the combination of age and patient distance to diagnosing dermatology provider was such a powerful predictor of the number of diagnosed melanomas,” Ms. Parisi said. “It’s probably due to less mobility among older patients living in more remote areas, and it puts them at higher risk of multiple melanomas. This was something we haven’t seen in the dermatology literature.”
She and her coauthors acknowledged that the limited sampling of patients from a single practice “may not generalize across all urban and rural settings, and results must be considered preliminary,” they wrote. However, “our findings reveal an important vulnerability among older patients in nonurban areas, and efforts to improve access to melanoma diagnosis should be concentrated on this geodemographic segment.”
Nikolai Klebanov, MD, of the department of dermatology at Massachusetts General Hospital, Boston, who was asked to comment on the study, described what was addressed in the study as a “timely and an important topic.”
In an interview, he said, “there is less access to dermatologists and other medical specialists outside of large metropolitan and suburban areas,” and there are other health disparities affecting people living in rural or more underserved areas, which, he added, “also became exacerbated by the COVID-19 pandemic.”
For future studies on this topic, Dr. Klebanov said that he would be interested to see diagnoses measured per person-year rather than the total number of melanomas diagnosed. “More elderly patients may also be those who have ‘stuck with the practice’ for longer, and had a longer follow-up that gives more time to catch more melanomas,” he said.
“Adjusting for median income using ZIP codes could also help adjust for socioeconomic status, which would help with external validity of the study. Income relationships to geography are not the same in all cities; some have wealthy suburbs within 20 miles, while some have more underserved and rural areas at that distance.”
Neither the researchers nor Dr. Klebanov reported having financial disclosures.
FROM JAMA DERMATOLOGY
Hospitals struggle to find nurses, beds, even oxygen as Delta surges
The state of Mississippi is out of intensive care unit beds. The University of Mississippi Medical Center in Jackson – the state’s largest health system – is converting part of a parking garage into a field hospital to make more room.
“Hospitals are full from Memphis to Gulfport, Natchez to Meridian. Everything’s full,” said Alan Jones, MD, the hospital’s COVID-19 response leader, in a press briefing Aug. 11.
The state has requested the help of a federal disaster medical assistance team of physicians, nurses, respiratory therapists, pharmacists, and paramedics to staff the extra beds. The goal is to open the field hospital on Aug. 13.
Arkansas hospitals have as little as eight ICU beds left to serve a population of 3 million people. Alabama isn’t far behind.
As of Aug. 10, several large metro Atlanta hospitals were diverting patients because they were full.
Hospitals in Alabama, Florida, Tennessee, and Texas are canceling elective surgeries, as they are flooded with COVID patients.
Florida has ordered more ventilators from the federal government. Some hospitals in that state have so many patients on high-flow medical oxygen that it is taxing the building supply lines.
“Most hospitals were not designed for this type of volume distribution in their facilities,” said Mary Mayhew, president of the Florida Hospital Association.
That’s when they can get it. Oxygen deliveries have been disrupted because of a shortage of drivers who are trained to transport it.
“Any disruption in the timing of a delivery can be hugely problematic because of the volume of oxygen they’re going through,” Ms. Mayhew said.
Hospitals ‘under great stress’
Over the month of June, the number of COVID patients in Florida hospitals soared from 2,000 to 10,000. Ms. Mayhew says it took twice as long during the last surge for the state to reach those numbers. And they’re still climbing. The state had 15,000 hospitalized COVID patients as of Aug. 11.
COVID hospitalizations tripled in 3 weeks in South Carolina, said state epidemiologist Linda Bell, MD, in a news conference Aug. 11.
“These hospitals are under great stress,” says Eric Toner, MD, a senior scientist at the Johns Hopkins Center for Health Security in Baltimore
The Delta variant has swept through the unvaccinated South with such veracity that hospitals in the region are unable to keep up. Patients with non-COVID health conditions are in jeopardy too.
Lee Owens, age 56, said he was supposed to have triple bypass surgery on Aug. 12 at St. Thomas West Hospital in Nashville, Tenn. Three of the arteries around his heart are 100%, 90%, and 70% blocked. Mr. Owens said the hospital called him Aug. 10 to postpone his surgery because they’ve cut back elective procedures to just one each day because the ICU beds there are full.
“I’m okay with having to wait a few days (my family isn’t!), especially if there are people worse than me, but so much anger at the reason,” he said. “These idiots that refused health care are now taking up my slot for heart surgery. It’s really aggravating.”
Anjali Bright, a spokesperson for St. Thomas West, provided a statement to this news organization saying they are not suspending elective procedures, but they are reviewing those “requiring an inpatient stay on a case-by-case basis.”
She emphasized, though, that “we will never delay care if the patient’s status changes to ‘urgent.’ ”
“Because of how infectious this variant is, this has the potential to be so much worse than what we saw in January,” said Donald Williamson, MD, president of the Alabama Hospital Association.
Dr. Williamson said they have modeled three possible scenarios for spread in the state, which ranks dead last in the United States for vaccination, with just 35% of its population fully protected. If the Delta variant spreads as it did in the United Kingdom, Alabama could see it hospitalize up to 3,000 people.
“That’s the best scenario,” he said.
If it sweeps through the state as it did in India, Alabama is looking at up to 4,500 patients hospitalized, a number that would require more beds and more staff to care for patients.
Then, there is what Dr. Williamson calls his “nightmare scenario.” If the entire state begins to see transmission rates as high as they’re currently seeing in coastal Mobile and Baldwin counties, that could mean up to 8,000 people in the hospital.
“If we see R-naughts of 5-8 statewide, we’re in real trouble,” he said. The R-naught is the basic rate of reproduction, and it means that each infected person would go on to infect 5-8 others. Dr. Williamson said the federal government would have to send them more staff to handle that kind of a surge.
‘Sense of betrayal’
Unlike the surges of last winter and spring, which sent hospitals scrambling for beds and supplies, the biggest pain point for hospitals now is staffing.
In Mississippi, where 200 patients are parked in emergency departments waiting for available and staffed ICU beds, the state is facing Delta with 2,000 fewer registered nurses than it had during its winter surge.
Some have left because of stress and burnout. Others have taken higher-paying jobs with travel nursing companies. To stop the exodus, hospitals are offering better pay, easier schedules, and sign-on and stay-on bonuses.
Doctors say the incentives are nice, but they don’t help with the anguish and anger many feel after months of battling COVID.
“There’s a big sense of betrayal,” said Sarah Nafziger, MD, vice president of clinical support services at the University of Alabama at Birmingham Hospital. “Our staff and health care workers, in general, feel like we’ve been betrayed by the community.”
“We have a vaccine, which is the key to ending this pandemic and people just refuse to take it, and so I think we’re very frustrated. We feel that our communities have let us down by not taking advantage of the vaccine,” Dr. Nafziger said. “It’s just baffling to me and it’s broken my heart every single day.”
Dr. Nafziger said she met with several surgeons at UAB on Aug. 11 and began making decisions about which surgeries would need to be canceled the following week. “We’re talking about cancer surgery. We’re talking about heart surgery. We’re talking about things that are critical to people.”
Compounding the staffing problems, about half of hospital workers in Alabama are still unvaccinated. Dr. Williamson says they’re now starting to see these unvaccinated health care workers come down with COVID too. He says that will exacerbate their surge even further as health care workers become too sick to help care for patients and some will end up needing hospital beds themselves.
At the University of Mississippi Medical Center, 70 hospital employees and another 20 clinic employees are now being quarantined or have COVID, Dr. Jones said.
“The situation is bleak for Mississippi hospitals,” said Timothy Moore, president and CEO of the Mississippi Hospital Association. He said he doesn’t expect it to get better anytime soon.
Mississippi has more patients hospitalized now than at any other point in the pandemic, said Thomas Dobbs, MD, MPH, the state epidemiologist.
“If we look at the rapidity of this rise, it’s really kind of terrifying and awe-inspiring,” Dr. Dobbs said in a news conference Aug. 11.
Schools are just starting back, and, in many parts of the South, districts are operating under a patchwork of policies – some require masks, while others have made them voluntary. Physicians say they are bracing for what these half measures could mean for pediatric cases and community transmission.
The only sure way for people to help themselves and their hospitals and schools, experts said, is vaccination.
“State data show that in this latest COVID surge, 97% of new COVID-19 infections, 89% of hospitalizations, and 82% of deaths occur in unvaccinated residents,” Mr. Moore said.
“To relieve pressure on hospitals, we need Mississippians – even those who have previously had COVID – to get vaccinated and wear a mask in public. The Delta variant is highly contagious and we need to do all we can to stop the spread,” he said.
A version of this article first appeared on Medscape.com.
The state of Mississippi is out of intensive care unit beds. The University of Mississippi Medical Center in Jackson – the state’s largest health system – is converting part of a parking garage into a field hospital to make more room.
“Hospitals are full from Memphis to Gulfport, Natchez to Meridian. Everything’s full,” said Alan Jones, MD, the hospital’s COVID-19 response leader, in a press briefing Aug. 11.
The state has requested the help of a federal disaster medical assistance team of physicians, nurses, respiratory therapists, pharmacists, and paramedics to staff the extra beds. The goal is to open the field hospital on Aug. 13.
Arkansas hospitals have as little as eight ICU beds left to serve a population of 3 million people. Alabama isn’t far behind.
As of Aug. 10, several large metro Atlanta hospitals were diverting patients because they were full.
Hospitals in Alabama, Florida, Tennessee, and Texas are canceling elective surgeries, as they are flooded with COVID patients.
Florida has ordered more ventilators from the federal government. Some hospitals in that state have so many patients on high-flow medical oxygen that it is taxing the building supply lines.
“Most hospitals were not designed for this type of volume distribution in their facilities,” said Mary Mayhew, president of the Florida Hospital Association.
That’s when they can get it. Oxygen deliveries have been disrupted because of a shortage of drivers who are trained to transport it.
“Any disruption in the timing of a delivery can be hugely problematic because of the volume of oxygen they’re going through,” Ms. Mayhew said.
Hospitals ‘under great stress’
Over the month of June, the number of COVID patients in Florida hospitals soared from 2,000 to 10,000. Ms. Mayhew says it took twice as long during the last surge for the state to reach those numbers. And they’re still climbing. The state had 15,000 hospitalized COVID patients as of Aug. 11.
COVID hospitalizations tripled in 3 weeks in South Carolina, said state epidemiologist Linda Bell, MD, in a news conference Aug. 11.
“These hospitals are under great stress,” says Eric Toner, MD, a senior scientist at the Johns Hopkins Center for Health Security in Baltimore
The Delta variant has swept through the unvaccinated South with such veracity that hospitals in the region are unable to keep up. Patients with non-COVID health conditions are in jeopardy too.
Lee Owens, age 56, said he was supposed to have triple bypass surgery on Aug. 12 at St. Thomas West Hospital in Nashville, Tenn. Three of the arteries around his heart are 100%, 90%, and 70% blocked. Mr. Owens said the hospital called him Aug. 10 to postpone his surgery because they’ve cut back elective procedures to just one each day because the ICU beds there are full.
“I’m okay with having to wait a few days (my family isn’t!), especially if there are people worse than me, but so much anger at the reason,” he said. “These idiots that refused health care are now taking up my slot for heart surgery. It’s really aggravating.”
Anjali Bright, a spokesperson for St. Thomas West, provided a statement to this news organization saying they are not suspending elective procedures, but they are reviewing those “requiring an inpatient stay on a case-by-case basis.”
She emphasized, though, that “we will never delay care if the patient’s status changes to ‘urgent.’ ”
“Because of how infectious this variant is, this has the potential to be so much worse than what we saw in January,” said Donald Williamson, MD, president of the Alabama Hospital Association.
Dr. Williamson said they have modeled three possible scenarios for spread in the state, which ranks dead last in the United States for vaccination, with just 35% of its population fully protected. If the Delta variant spreads as it did in the United Kingdom, Alabama could see it hospitalize up to 3,000 people.
“That’s the best scenario,” he said.
If it sweeps through the state as it did in India, Alabama is looking at up to 4,500 patients hospitalized, a number that would require more beds and more staff to care for patients.
Then, there is what Dr. Williamson calls his “nightmare scenario.” If the entire state begins to see transmission rates as high as they’re currently seeing in coastal Mobile and Baldwin counties, that could mean up to 8,000 people in the hospital.
“If we see R-naughts of 5-8 statewide, we’re in real trouble,” he said. The R-naught is the basic rate of reproduction, and it means that each infected person would go on to infect 5-8 others. Dr. Williamson said the federal government would have to send them more staff to handle that kind of a surge.
‘Sense of betrayal’
Unlike the surges of last winter and spring, which sent hospitals scrambling for beds and supplies, the biggest pain point for hospitals now is staffing.
In Mississippi, where 200 patients are parked in emergency departments waiting for available and staffed ICU beds, the state is facing Delta with 2,000 fewer registered nurses than it had during its winter surge.
Some have left because of stress and burnout. Others have taken higher-paying jobs with travel nursing companies. To stop the exodus, hospitals are offering better pay, easier schedules, and sign-on and stay-on bonuses.
Doctors say the incentives are nice, but they don’t help with the anguish and anger many feel after months of battling COVID.
“There’s a big sense of betrayal,” said Sarah Nafziger, MD, vice president of clinical support services at the University of Alabama at Birmingham Hospital. “Our staff and health care workers, in general, feel like we’ve been betrayed by the community.”
“We have a vaccine, which is the key to ending this pandemic and people just refuse to take it, and so I think we’re very frustrated. We feel that our communities have let us down by not taking advantage of the vaccine,” Dr. Nafziger said. “It’s just baffling to me and it’s broken my heart every single day.”
Dr. Nafziger said she met with several surgeons at UAB on Aug. 11 and began making decisions about which surgeries would need to be canceled the following week. “We’re talking about cancer surgery. We’re talking about heart surgery. We’re talking about things that are critical to people.”
Compounding the staffing problems, about half of hospital workers in Alabama are still unvaccinated. Dr. Williamson says they’re now starting to see these unvaccinated health care workers come down with COVID too. He says that will exacerbate their surge even further as health care workers become too sick to help care for patients and some will end up needing hospital beds themselves.
At the University of Mississippi Medical Center, 70 hospital employees and another 20 clinic employees are now being quarantined or have COVID, Dr. Jones said.
“The situation is bleak for Mississippi hospitals,” said Timothy Moore, president and CEO of the Mississippi Hospital Association. He said he doesn’t expect it to get better anytime soon.
Mississippi has more patients hospitalized now than at any other point in the pandemic, said Thomas Dobbs, MD, MPH, the state epidemiologist.
“If we look at the rapidity of this rise, it’s really kind of terrifying and awe-inspiring,” Dr. Dobbs said in a news conference Aug. 11.
Schools are just starting back, and, in many parts of the South, districts are operating under a patchwork of policies – some require masks, while others have made them voluntary. Physicians say they are bracing for what these half measures could mean for pediatric cases and community transmission.
The only sure way for people to help themselves and their hospitals and schools, experts said, is vaccination.
“State data show that in this latest COVID surge, 97% of new COVID-19 infections, 89% of hospitalizations, and 82% of deaths occur in unvaccinated residents,” Mr. Moore said.
“To relieve pressure on hospitals, we need Mississippians – even those who have previously had COVID – to get vaccinated and wear a mask in public. The Delta variant is highly contagious and we need to do all we can to stop the spread,” he said.
A version of this article first appeared on Medscape.com.
The state of Mississippi is out of intensive care unit beds. The University of Mississippi Medical Center in Jackson – the state’s largest health system – is converting part of a parking garage into a field hospital to make more room.
“Hospitals are full from Memphis to Gulfport, Natchez to Meridian. Everything’s full,” said Alan Jones, MD, the hospital’s COVID-19 response leader, in a press briefing Aug. 11.
The state has requested the help of a federal disaster medical assistance team of physicians, nurses, respiratory therapists, pharmacists, and paramedics to staff the extra beds. The goal is to open the field hospital on Aug. 13.
Arkansas hospitals have as little as eight ICU beds left to serve a population of 3 million people. Alabama isn’t far behind.
As of Aug. 10, several large metro Atlanta hospitals were diverting patients because they were full.
Hospitals in Alabama, Florida, Tennessee, and Texas are canceling elective surgeries, as they are flooded with COVID patients.
Florida has ordered more ventilators from the federal government. Some hospitals in that state have so many patients on high-flow medical oxygen that it is taxing the building supply lines.
“Most hospitals were not designed for this type of volume distribution in their facilities,” said Mary Mayhew, president of the Florida Hospital Association.
That’s when they can get it. Oxygen deliveries have been disrupted because of a shortage of drivers who are trained to transport it.
“Any disruption in the timing of a delivery can be hugely problematic because of the volume of oxygen they’re going through,” Ms. Mayhew said.
Hospitals ‘under great stress’
Over the month of June, the number of COVID patients in Florida hospitals soared from 2,000 to 10,000. Ms. Mayhew says it took twice as long during the last surge for the state to reach those numbers. And they’re still climbing. The state had 15,000 hospitalized COVID patients as of Aug. 11.
COVID hospitalizations tripled in 3 weeks in South Carolina, said state epidemiologist Linda Bell, MD, in a news conference Aug. 11.
“These hospitals are under great stress,” says Eric Toner, MD, a senior scientist at the Johns Hopkins Center for Health Security in Baltimore
The Delta variant has swept through the unvaccinated South with such veracity that hospitals in the region are unable to keep up. Patients with non-COVID health conditions are in jeopardy too.
Lee Owens, age 56, said he was supposed to have triple bypass surgery on Aug. 12 at St. Thomas West Hospital in Nashville, Tenn. Three of the arteries around his heart are 100%, 90%, and 70% blocked. Mr. Owens said the hospital called him Aug. 10 to postpone his surgery because they’ve cut back elective procedures to just one each day because the ICU beds there are full.
“I’m okay with having to wait a few days (my family isn’t!), especially if there are people worse than me, but so much anger at the reason,” he said. “These idiots that refused health care are now taking up my slot for heart surgery. It’s really aggravating.”
Anjali Bright, a spokesperson for St. Thomas West, provided a statement to this news organization saying they are not suspending elective procedures, but they are reviewing those “requiring an inpatient stay on a case-by-case basis.”
She emphasized, though, that “we will never delay care if the patient’s status changes to ‘urgent.’ ”
“Because of how infectious this variant is, this has the potential to be so much worse than what we saw in January,” said Donald Williamson, MD, president of the Alabama Hospital Association.
Dr. Williamson said they have modeled three possible scenarios for spread in the state, which ranks dead last in the United States for vaccination, with just 35% of its population fully protected. If the Delta variant spreads as it did in the United Kingdom, Alabama could see it hospitalize up to 3,000 people.
“That’s the best scenario,” he said.
If it sweeps through the state as it did in India, Alabama is looking at up to 4,500 patients hospitalized, a number that would require more beds and more staff to care for patients.
Then, there is what Dr. Williamson calls his “nightmare scenario.” If the entire state begins to see transmission rates as high as they’re currently seeing in coastal Mobile and Baldwin counties, that could mean up to 8,000 people in the hospital.
“If we see R-naughts of 5-8 statewide, we’re in real trouble,” he said. The R-naught is the basic rate of reproduction, and it means that each infected person would go on to infect 5-8 others. Dr. Williamson said the federal government would have to send them more staff to handle that kind of a surge.
‘Sense of betrayal’
Unlike the surges of last winter and spring, which sent hospitals scrambling for beds and supplies, the biggest pain point for hospitals now is staffing.
In Mississippi, where 200 patients are parked in emergency departments waiting for available and staffed ICU beds, the state is facing Delta with 2,000 fewer registered nurses than it had during its winter surge.
Some have left because of stress and burnout. Others have taken higher-paying jobs with travel nursing companies. To stop the exodus, hospitals are offering better pay, easier schedules, and sign-on and stay-on bonuses.
Doctors say the incentives are nice, but they don’t help with the anguish and anger many feel after months of battling COVID.
“There’s a big sense of betrayal,” said Sarah Nafziger, MD, vice president of clinical support services at the University of Alabama at Birmingham Hospital. “Our staff and health care workers, in general, feel like we’ve been betrayed by the community.”
“We have a vaccine, which is the key to ending this pandemic and people just refuse to take it, and so I think we’re very frustrated. We feel that our communities have let us down by not taking advantage of the vaccine,” Dr. Nafziger said. “It’s just baffling to me and it’s broken my heart every single day.”
Dr. Nafziger said she met with several surgeons at UAB on Aug. 11 and began making decisions about which surgeries would need to be canceled the following week. “We’re talking about cancer surgery. We’re talking about heart surgery. We’re talking about things that are critical to people.”
Compounding the staffing problems, about half of hospital workers in Alabama are still unvaccinated. Dr. Williamson says they’re now starting to see these unvaccinated health care workers come down with COVID too. He says that will exacerbate their surge even further as health care workers become too sick to help care for patients and some will end up needing hospital beds themselves.
At the University of Mississippi Medical Center, 70 hospital employees and another 20 clinic employees are now being quarantined or have COVID, Dr. Jones said.
“The situation is bleak for Mississippi hospitals,” said Timothy Moore, president and CEO of the Mississippi Hospital Association. He said he doesn’t expect it to get better anytime soon.
Mississippi has more patients hospitalized now than at any other point in the pandemic, said Thomas Dobbs, MD, MPH, the state epidemiologist.
“If we look at the rapidity of this rise, it’s really kind of terrifying and awe-inspiring,” Dr. Dobbs said in a news conference Aug. 11.
Schools are just starting back, and, in many parts of the South, districts are operating under a patchwork of policies – some require masks, while others have made them voluntary. Physicians say they are bracing for what these half measures could mean for pediatric cases and community transmission.
The only sure way for people to help themselves and their hospitals and schools, experts said, is vaccination.
“State data show that in this latest COVID surge, 97% of new COVID-19 infections, 89% of hospitalizations, and 82% of deaths occur in unvaccinated residents,” Mr. Moore said.
“To relieve pressure on hospitals, we need Mississippians – even those who have previously had COVID – to get vaccinated and wear a mask in public. The Delta variant is highly contagious and we need to do all we can to stop the spread,” he said.
A version of this article first appeared on Medscape.com.
Soccer star med student fled the Taliban, about to be doctor: A Q&A with Nadia Nadim
At the end of 2021, Nadia Nadim will join the tens of thousands of medical students who will exchange their short white coats for the long ones of practicing physicians. Unlike other future doctors, this soon-to-be reconstructive surgeon has also been wearing a uniform that’s more than white. She has donned brightly colored red, purple, or blue jerseys as a striker for teams in the U.S. National Women’s Soccer League and the Danish National football team.
The 33-year-old found her way into medicine after a harrowing childhood. Following the murder of her father by the Taliban, Nadia, her mother, and her four sisters fled Afghanistan in fear for their lives. They sought refuge in Denmark, where Nadia first discovered football [soccer] and a growing call to become a humanitarian activist.
This interview has been edited for length and clarity.
Question: Would you mind telling us a bit about your background and your journey into medicine?
Nadia: I was born in Afghanistan and was raised there until I was 10 years old. Then we had to flee the country because of war. We came to Denmark at the start of sixth grade. At that point, I didn’t really understand the language. I didn’t understand a lot of things. The only thing I kind of knew was math because my mom was teaching us at home.
My mom had always emphasized the importance of education. She said that it can get you out of any situation in your life. If you’re having problems or are in poverty or whatever, education is the key. She was the first kid in her family to get education. No one before her ever went to school, especially not girls.
My mom wanted to become a doctor, but then she got married and her plans changed. She always had this dream and then wanted one of her kids to become a doctor. When I heard that I was like: “Hell no, I’m not gonna. I’m not gonna fulfill your dreams.” My older sister wanted to become a doctor, and I was like: “I’m not gonna become a doctor. I’m gonna do something else. I’m gonna try to become rich.”
I remember in ninth grade, we had this one week where you get to choose what you want to do. I chose to go to the clinic close to our house, not because I had the biggest interest but because it was close and I could sleep in longer.
The week that I was there, I was really surprised. I thought: “Wow, this is really cool to be in the hospital.” I saw some cosmetic operations and eye surgeries. I could see myself in that environment. I love the fact the doctors are able to help people, especially the ones who are really in need. I thought “Maybe I should give this a go.”
So I signed up (for medical school). I got in. I didn’t tell my mom. I told her that I applied to business school and was accepted. She’s was half-heartedly saying: “Oh, I’m so proud of you!” She didn’t really mean it.
I remember being in the first semester and thinking: “I’ve chosen so right.” I loved everything about med school, from the blood to the conversations that you have with your patients. I love it.
Obviously, football is a big part of your life as well. How have you balanced medical training with your work as an athlete on a global stage?
It hasn’t been easy. I did my bachelor’s degree as normal as everyone else because it was possible for me to be in school from 7 a.m. to 3 p.m. My football training was at 6 p.m. It was possible but also really tough.
We have these huge exams in Denmark where you are literally tested on six, seven, or eight big subjects. The failure rate is really high. I was selected for the Danish national team. The time for my exam was literally the same time that I was about to go to camp. I remember there was this lady ... I explained my problem, and she said: “Well, I’m sorry, this is it. You have to make a choice. No one can play football and be a doctor, so I guess you have to make a choice.” I wanted to prove her wrong.
What advice would you have for students who may be in such similar situations, in which they have a counselor or an advisor who isn’t very supportive?
I think there’s always two ways: Either you’re gonna listen and be like “okay, this is it. I give up.” Or, if you’re really passionate about it, you’re gonna go the hard way, which is that you do your thing and then slowly everything is gonna go your way.
I think it’s just about being strong enough to “do you.” I think that’s important. Don’t just give up easily just because you’ve been told: ‘We’ve never done this before. It’s impossible.’ I don’t believe that [impossible] is something that exists. I think if you want to do something, there’s always a way. You just have to find it.
I have never taken no for an answer, I guess. But it’s not gonna be easy.
Given all that is on your plate, how do you avoid burnout?
I love doing active stuff. I have a lot of hobbies. I also enjoy just chilling. If my football allows it, and I’m fresh, I love to do stuff outside like tennis, basketball, and swimming.
I love to watch Bollywood movies, just because I speak Hindi. They have something a bit magical around them, like fairy tale movies. I love to watch Korean dramas. I think I’m always interested in other cultures.
You also have a lot of other projects in the works. Could you tell us briefly about some that you’re currently working on?
One of the things that is really close to my heart and I’m passionate about is volunteer work. You know, the humanitarian organizations that do so much in the world. I’ve been on the receiving hand on the other side. I know that a little tiny help can have a huge impact on your character and your future. That’s probably also one of the reasons I want to be a doctor.
One of the organizations that I work with is the Danish Refugee Council. I have visited refugee camps around the world. I’ve been in Jordan and Kenya, and also Denmark. I’m also ambassador for [United Nations Educational, Scientific, and Cultural Organization] UNESCO’s education for girls. Because, again, I think education is the key to a lot of the problems we do face right now.
For instance, let’s say racism, which is a huge thing. You could probably decrease that by educating people. Ignorance, I think, is a huge factor, the fear that you see among a lot of people because of Islam. It’s just people being ignorant. They don’t know. They just assume or they see a certain group and think that they are the representation for the entire population. All of this ends with education.
If you could educate people, I think a lot of problems would disappear or at least get better. So yeah, I am really busy. But whenever I have a bit of time, I try to use it on making a change.
I started by saying that my mom said education is very important. I think that’s something that my entire family has taken to. My oldest [sister] is a doctor, and then I have two nurses in the family, my youngest sisters. I think a goal is to have a clinic all together.
At the end of 2021, Nadia Nadim will join the tens of thousands of medical students who will exchange their short white coats for the long ones of practicing physicians. Unlike other future doctors, this soon-to-be reconstructive surgeon has also been wearing a uniform that’s more than white. She has donned brightly colored red, purple, or blue jerseys as a striker for teams in the U.S. National Women’s Soccer League and the Danish National football team.
The 33-year-old found her way into medicine after a harrowing childhood. Following the murder of her father by the Taliban, Nadia, her mother, and her four sisters fled Afghanistan in fear for their lives. They sought refuge in Denmark, where Nadia first discovered football [soccer] and a growing call to become a humanitarian activist.
This interview has been edited for length and clarity.
Question: Would you mind telling us a bit about your background and your journey into medicine?
Nadia: I was born in Afghanistan and was raised there until I was 10 years old. Then we had to flee the country because of war. We came to Denmark at the start of sixth grade. At that point, I didn’t really understand the language. I didn’t understand a lot of things. The only thing I kind of knew was math because my mom was teaching us at home.
My mom had always emphasized the importance of education. She said that it can get you out of any situation in your life. If you’re having problems or are in poverty or whatever, education is the key. She was the first kid in her family to get education. No one before her ever went to school, especially not girls.
My mom wanted to become a doctor, but then she got married and her plans changed. She always had this dream and then wanted one of her kids to become a doctor. When I heard that I was like: “Hell no, I’m not gonna. I’m not gonna fulfill your dreams.” My older sister wanted to become a doctor, and I was like: “I’m not gonna become a doctor. I’m gonna do something else. I’m gonna try to become rich.”
I remember in ninth grade, we had this one week where you get to choose what you want to do. I chose to go to the clinic close to our house, not because I had the biggest interest but because it was close and I could sleep in longer.
The week that I was there, I was really surprised. I thought: “Wow, this is really cool to be in the hospital.” I saw some cosmetic operations and eye surgeries. I could see myself in that environment. I love the fact the doctors are able to help people, especially the ones who are really in need. I thought “Maybe I should give this a go.”
So I signed up (for medical school). I got in. I didn’t tell my mom. I told her that I applied to business school and was accepted. She’s was half-heartedly saying: “Oh, I’m so proud of you!” She didn’t really mean it.
I remember being in the first semester and thinking: “I’ve chosen so right.” I loved everything about med school, from the blood to the conversations that you have with your patients. I love it.
Obviously, football is a big part of your life as well. How have you balanced medical training with your work as an athlete on a global stage?
It hasn’t been easy. I did my bachelor’s degree as normal as everyone else because it was possible for me to be in school from 7 a.m. to 3 p.m. My football training was at 6 p.m. It was possible but also really tough.
We have these huge exams in Denmark where you are literally tested on six, seven, or eight big subjects. The failure rate is really high. I was selected for the Danish national team. The time for my exam was literally the same time that I was about to go to camp. I remember there was this lady ... I explained my problem, and she said: “Well, I’m sorry, this is it. You have to make a choice. No one can play football and be a doctor, so I guess you have to make a choice.” I wanted to prove her wrong.
What advice would you have for students who may be in such similar situations, in which they have a counselor or an advisor who isn’t very supportive?
I think there’s always two ways: Either you’re gonna listen and be like “okay, this is it. I give up.” Or, if you’re really passionate about it, you’re gonna go the hard way, which is that you do your thing and then slowly everything is gonna go your way.
I think it’s just about being strong enough to “do you.” I think that’s important. Don’t just give up easily just because you’ve been told: ‘We’ve never done this before. It’s impossible.’ I don’t believe that [impossible] is something that exists. I think if you want to do something, there’s always a way. You just have to find it.
I have never taken no for an answer, I guess. But it’s not gonna be easy.
Given all that is on your plate, how do you avoid burnout?
I love doing active stuff. I have a lot of hobbies. I also enjoy just chilling. If my football allows it, and I’m fresh, I love to do stuff outside like tennis, basketball, and swimming.
I love to watch Bollywood movies, just because I speak Hindi. They have something a bit magical around them, like fairy tale movies. I love to watch Korean dramas. I think I’m always interested in other cultures.
You also have a lot of other projects in the works. Could you tell us briefly about some that you’re currently working on?
One of the things that is really close to my heart and I’m passionate about is volunteer work. You know, the humanitarian organizations that do so much in the world. I’ve been on the receiving hand on the other side. I know that a little tiny help can have a huge impact on your character and your future. That’s probably also one of the reasons I want to be a doctor.
One of the organizations that I work with is the Danish Refugee Council. I have visited refugee camps around the world. I’ve been in Jordan and Kenya, and also Denmark. I’m also ambassador for [United Nations Educational, Scientific, and Cultural Organization] UNESCO’s education for girls. Because, again, I think education is the key to a lot of the problems we do face right now.
For instance, let’s say racism, which is a huge thing. You could probably decrease that by educating people. Ignorance, I think, is a huge factor, the fear that you see among a lot of people because of Islam. It’s just people being ignorant. They don’t know. They just assume or they see a certain group and think that they are the representation for the entire population. All of this ends with education.
If you could educate people, I think a lot of problems would disappear or at least get better. So yeah, I am really busy. But whenever I have a bit of time, I try to use it on making a change.
I started by saying that my mom said education is very important. I think that’s something that my entire family has taken to. My oldest [sister] is a doctor, and then I have two nurses in the family, my youngest sisters. I think a goal is to have a clinic all together.
At the end of 2021, Nadia Nadim will join the tens of thousands of medical students who will exchange their short white coats for the long ones of practicing physicians. Unlike other future doctors, this soon-to-be reconstructive surgeon has also been wearing a uniform that’s more than white. She has donned brightly colored red, purple, or blue jerseys as a striker for teams in the U.S. National Women’s Soccer League and the Danish National football team.
The 33-year-old found her way into medicine after a harrowing childhood. Following the murder of her father by the Taliban, Nadia, her mother, and her four sisters fled Afghanistan in fear for their lives. They sought refuge in Denmark, where Nadia first discovered football [soccer] and a growing call to become a humanitarian activist.
This interview has been edited for length and clarity.
Question: Would you mind telling us a bit about your background and your journey into medicine?
Nadia: I was born in Afghanistan and was raised there until I was 10 years old. Then we had to flee the country because of war. We came to Denmark at the start of sixth grade. At that point, I didn’t really understand the language. I didn’t understand a lot of things. The only thing I kind of knew was math because my mom was teaching us at home.
My mom had always emphasized the importance of education. She said that it can get you out of any situation in your life. If you’re having problems or are in poverty or whatever, education is the key. She was the first kid in her family to get education. No one before her ever went to school, especially not girls.
My mom wanted to become a doctor, but then she got married and her plans changed. She always had this dream and then wanted one of her kids to become a doctor. When I heard that I was like: “Hell no, I’m not gonna. I’m not gonna fulfill your dreams.” My older sister wanted to become a doctor, and I was like: “I’m not gonna become a doctor. I’m gonna do something else. I’m gonna try to become rich.”
I remember in ninth grade, we had this one week where you get to choose what you want to do. I chose to go to the clinic close to our house, not because I had the biggest interest but because it was close and I could sleep in longer.
The week that I was there, I was really surprised. I thought: “Wow, this is really cool to be in the hospital.” I saw some cosmetic operations and eye surgeries. I could see myself in that environment. I love the fact the doctors are able to help people, especially the ones who are really in need. I thought “Maybe I should give this a go.”
So I signed up (for medical school). I got in. I didn’t tell my mom. I told her that I applied to business school and was accepted. She’s was half-heartedly saying: “Oh, I’m so proud of you!” She didn’t really mean it.
I remember being in the first semester and thinking: “I’ve chosen so right.” I loved everything about med school, from the blood to the conversations that you have with your patients. I love it.
Obviously, football is a big part of your life as well. How have you balanced medical training with your work as an athlete on a global stage?
It hasn’t been easy. I did my bachelor’s degree as normal as everyone else because it was possible for me to be in school from 7 a.m. to 3 p.m. My football training was at 6 p.m. It was possible but also really tough.
We have these huge exams in Denmark where you are literally tested on six, seven, or eight big subjects. The failure rate is really high. I was selected for the Danish national team. The time for my exam was literally the same time that I was about to go to camp. I remember there was this lady ... I explained my problem, and she said: “Well, I’m sorry, this is it. You have to make a choice. No one can play football and be a doctor, so I guess you have to make a choice.” I wanted to prove her wrong.
What advice would you have for students who may be in such similar situations, in which they have a counselor or an advisor who isn’t very supportive?
I think there’s always two ways: Either you’re gonna listen and be like “okay, this is it. I give up.” Or, if you’re really passionate about it, you’re gonna go the hard way, which is that you do your thing and then slowly everything is gonna go your way.
I think it’s just about being strong enough to “do you.” I think that’s important. Don’t just give up easily just because you’ve been told: ‘We’ve never done this before. It’s impossible.’ I don’t believe that [impossible] is something that exists. I think if you want to do something, there’s always a way. You just have to find it.
I have never taken no for an answer, I guess. But it’s not gonna be easy.
Given all that is on your plate, how do you avoid burnout?
I love doing active stuff. I have a lot of hobbies. I also enjoy just chilling. If my football allows it, and I’m fresh, I love to do stuff outside like tennis, basketball, and swimming.
I love to watch Bollywood movies, just because I speak Hindi. They have something a bit magical around them, like fairy tale movies. I love to watch Korean dramas. I think I’m always interested in other cultures.
You also have a lot of other projects in the works. Could you tell us briefly about some that you’re currently working on?
One of the things that is really close to my heart and I’m passionate about is volunteer work. You know, the humanitarian organizations that do so much in the world. I’ve been on the receiving hand on the other side. I know that a little tiny help can have a huge impact on your character and your future. That’s probably also one of the reasons I want to be a doctor.
One of the organizations that I work with is the Danish Refugee Council. I have visited refugee camps around the world. I’ve been in Jordan and Kenya, and also Denmark. I’m also ambassador for [United Nations Educational, Scientific, and Cultural Organization] UNESCO’s education for girls. Because, again, I think education is the key to a lot of the problems we do face right now.
For instance, let’s say racism, which is a huge thing. You could probably decrease that by educating people. Ignorance, I think, is a huge factor, the fear that you see among a lot of people because of Islam. It’s just people being ignorant. They don’t know. They just assume or they see a certain group and think that they are the representation for the entire population. All of this ends with education.
If you could educate people, I think a lot of problems would disappear or at least get better. So yeah, I am really busy. But whenever I have a bit of time, I try to use it on making a change.
I started by saying that my mom said education is very important. I think that’s something that my entire family has taken to. My oldest [sister] is a doctor, and then I have two nurses in the family, my youngest sisters. I think a goal is to have a clinic all together.