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Airways Disorders Network
Pediatric Chest Medicine Section
Hope is on the horizon—new RSV protection for all infants
as available preventive therapies are limited and currently reserved for former preterm infants and those with certain underlying medical conditions (Brady MT, et al. Pediatrics. 2014;134[2]:415). Globally, RSV is a significant cause of lower respiratory tract infection impacting all age groups, yet, in infants and young children, the first infection may cause severe bronchiolitis that can be fatal (Li Y, et al. Lancet. 2022;399:2047).
There are currently three approaches for protection at various stages of clinical development. The first is direct administration of antibodies to the infant. Two potent, longer-lasting, single-dose monoclonal antibody products, including nirsevimab which is a monoclonal antibody to the RSV fusion protein that has an extended half-life, for the general infant population are in phase 3 trials (Hammitt LL, et al. N Engl J Med. 2022;386:837; Griffin PM, et al. N Engl J Med. 2020;383:415).
Passive antibody acquired from maternal vaccination in pregnancy is a second approach. Notably, a recent phase 3 trial that evaluated maternal vaccination did not show significance with respect to the primary end point of medically significant RSV-associated lower respiratory tract infection in infants up to 90 days of life (Madhi SA. N Engl J Med. 2020;383:426).
The third type of protection is active vaccination. Increased understanding of the biology of RSV and related technological advances have resulted in the entry of multiple vaccines into clinical development for pediatrics and adults, some of which may receive regulatory approval in the near future (Munoz FM, et al. Vaccine. 2021;39[22]:3053).
The burden of RSV is tremendous, yet the future of RSV protection looks promising.
Anne C. Coates, MD, FCCP, Member-at-Large
Mary Cataletto, MD, FCCP, Member-at-Large
Pediatric Chest Medicine Section
Hope is on the horizon—new RSV protection for all infants
as available preventive therapies are limited and currently reserved for former preterm infants and those with certain underlying medical conditions (Brady MT, et al. Pediatrics. 2014;134[2]:415). Globally, RSV is a significant cause of lower respiratory tract infection impacting all age groups, yet, in infants and young children, the first infection may cause severe bronchiolitis that can be fatal (Li Y, et al. Lancet. 2022;399:2047).
There are currently three approaches for protection at various stages of clinical development. The first is direct administration of antibodies to the infant. Two potent, longer-lasting, single-dose monoclonal antibody products, including nirsevimab which is a monoclonal antibody to the RSV fusion protein that has an extended half-life, for the general infant population are in phase 3 trials (Hammitt LL, et al. N Engl J Med. 2022;386:837; Griffin PM, et al. N Engl J Med. 2020;383:415).
Passive antibody acquired from maternal vaccination in pregnancy is a second approach. Notably, a recent phase 3 trial that evaluated maternal vaccination did not show significance with respect to the primary end point of medically significant RSV-associated lower respiratory tract infection in infants up to 90 days of life (Madhi SA. N Engl J Med. 2020;383:426).
The third type of protection is active vaccination. Increased understanding of the biology of RSV and related technological advances have resulted in the entry of multiple vaccines into clinical development for pediatrics and adults, some of which may receive regulatory approval in the near future (Munoz FM, et al. Vaccine. 2021;39[22]:3053).
The burden of RSV is tremendous, yet the future of RSV protection looks promising.
Anne C. Coates, MD, FCCP, Member-at-Large
Mary Cataletto, MD, FCCP, Member-at-Large
Pediatric Chest Medicine Section
Hope is on the horizon—new RSV protection for all infants
as available preventive therapies are limited and currently reserved for former preterm infants and those with certain underlying medical conditions (Brady MT, et al. Pediatrics. 2014;134[2]:415). Globally, RSV is a significant cause of lower respiratory tract infection impacting all age groups, yet, in infants and young children, the first infection may cause severe bronchiolitis that can be fatal (Li Y, et al. Lancet. 2022;399:2047).
There are currently three approaches for protection at various stages of clinical development. The first is direct administration of antibodies to the infant. Two potent, longer-lasting, single-dose monoclonal antibody products, including nirsevimab which is a monoclonal antibody to the RSV fusion protein that has an extended half-life, for the general infant population are in phase 3 trials (Hammitt LL, et al. N Engl J Med. 2022;386:837; Griffin PM, et al. N Engl J Med. 2020;383:415).
Passive antibody acquired from maternal vaccination in pregnancy is a second approach. Notably, a recent phase 3 trial that evaluated maternal vaccination did not show significance with respect to the primary end point of medically significant RSV-associated lower respiratory tract infection in infants up to 90 days of life (Madhi SA. N Engl J Med. 2020;383:426).
The third type of protection is active vaccination. Increased understanding of the biology of RSV and related technological advances have resulted in the entry of multiple vaccines into clinical development for pediatrics and adults, some of which may receive regulatory approval in the near future (Munoz FM, et al. Vaccine. 2021;39[22]:3053).
The burden of RSV is tremendous, yet the future of RSV protection looks promising.
Anne C. Coates, MD, FCCP, Member-at-Large
Mary Cataletto, MD, FCCP, Member-at-Large
Critical Care Network
Sepsis and Shock Section
SEP-1 measure saves lives, let’s not debate!
On December 21, 2021, the National Quality Form (NQF) re-endorsed Measure 0500 Severe Sepsis and Septic Shock: Management Bundle, which CMS adopts as the SEP-1 core measure. The decision was initially met by a request for appeal. On April 29, 2022, the appeals board met to adjudicate the appeal and voted unanimously to uphold the Standards Approval Committee (CSAC) decision to endorse the measure once again (https://tinyurl.com/yc4tjxbz).
The appeals board voted 5-0 on whether procedural errors reasonably affected the outcome of the original endorsement and whether there was new information or evidence unavailable at the time of the CSAC endorsement decision that would reasonably affect the outcome of the original endorsement decision.
even though the results of this bundled approach support an opportunity to save lives. SEP-1 compliance is associated with a lower 30-day mortality, and rendering this care saves lives.
In the Townsend, et al cohort study (Chest. 2022 Feb;161[2]:392) examining patient level Medicare data from October 2015 – March 2017, there was an absolute risk reduction of 5.67% in a standard propensity matched comparison of SEP-1 compliant vs noncompliant care. With a more stringent match, the absolute risk reduction was 4.06%. That’s an outcome that our patients likely appreciate the most…lives saved.
As former CHEST President, Dr. Steven Simpson highlighted in his April 2022 commentary (CHEST Physician. 2022 April;17[4]:15), “Success is not dependent only on what we do but on when we do it.” Let’s not debate any further.
Namita Jayaprakash, MBBCh
Member-at-Large
Sepsis and Shock Section
SEP-1 measure saves lives, let’s not debate!
On December 21, 2021, the National Quality Form (NQF) re-endorsed Measure 0500 Severe Sepsis and Septic Shock: Management Bundle, which CMS adopts as the SEP-1 core measure. The decision was initially met by a request for appeal. On April 29, 2022, the appeals board met to adjudicate the appeal and voted unanimously to uphold the Standards Approval Committee (CSAC) decision to endorse the measure once again (https://tinyurl.com/yc4tjxbz).
The appeals board voted 5-0 on whether procedural errors reasonably affected the outcome of the original endorsement and whether there was new information or evidence unavailable at the time of the CSAC endorsement decision that would reasonably affect the outcome of the original endorsement decision.
even though the results of this bundled approach support an opportunity to save lives. SEP-1 compliance is associated with a lower 30-day mortality, and rendering this care saves lives.
In the Townsend, et al cohort study (Chest. 2022 Feb;161[2]:392) examining patient level Medicare data from October 2015 – March 2017, there was an absolute risk reduction of 5.67% in a standard propensity matched comparison of SEP-1 compliant vs noncompliant care. With a more stringent match, the absolute risk reduction was 4.06%. That’s an outcome that our patients likely appreciate the most…lives saved.
As former CHEST President, Dr. Steven Simpson highlighted in his April 2022 commentary (CHEST Physician. 2022 April;17[4]:15), “Success is not dependent only on what we do but on when we do it.” Let’s not debate any further.
Namita Jayaprakash, MBBCh
Member-at-Large
Sepsis and Shock Section
SEP-1 measure saves lives, let’s not debate!
On December 21, 2021, the National Quality Form (NQF) re-endorsed Measure 0500 Severe Sepsis and Septic Shock: Management Bundle, which CMS adopts as the SEP-1 core measure. The decision was initially met by a request for appeal. On April 29, 2022, the appeals board met to adjudicate the appeal and voted unanimously to uphold the Standards Approval Committee (CSAC) decision to endorse the measure once again (https://tinyurl.com/yc4tjxbz).
The appeals board voted 5-0 on whether procedural errors reasonably affected the outcome of the original endorsement and whether there was new information or evidence unavailable at the time of the CSAC endorsement decision that would reasonably affect the outcome of the original endorsement decision.
even though the results of this bundled approach support an opportunity to save lives. SEP-1 compliance is associated with a lower 30-day mortality, and rendering this care saves lives.
In the Townsend, et al cohort study (Chest. 2022 Feb;161[2]:392) examining patient level Medicare data from October 2015 – March 2017, there was an absolute risk reduction of 5.67% in a standard propensity matched comparison of SEP-1 compliant vs noncompliant care. With a more stringent match, the absolute risk reduction was 4.06%. That’s an outcome that our patients likely appreciate the most…lives saved.
As former CHEST President, Dr. Steven Simpson highlighted in his April 2022 commentary (CHEST Physician. 2022 April;17[4]:15), “Success is not dependent only on what we do but on when we do it.” Let’s not debate any further.
Namita Jayaprakash, MBBCh
Member-at-Large
Sleep Medicine Network
Respiratory-Related Sleep Disorders Section
Reducing racial disparities in sleep apnea
For example, a growing body of research has shown that black race is associated with underdiagnosis of OSA, greater disease severity at time of diagnosis and reduced PAP adherence (Hsu N, et al. J Clin Sleep Med. 2020;16[8]:1249; Thornton JD, et al. Ann Am Thorac Soc. 2022;19[2]:272).
A recent article (Billings ME, et al. Chest. 2021;159[3]:1232) offered potential strategies to mitigate racial disparities in sleep apnea management. To expand access to care, they advocate embracing telemedicine for those who may have difficulty coming to clinic – due to transportation issues, arranging sufficient time off work, or residing in remote locations. On the other hand, an over-reliance on telemedicine has the potential to worsen disparities in populations whose access to technology is limited.
The authors also recommend inpatient screening of high-risk patient populations to detect disease earlier and to help facilitate referrals to a sleep center. They propose the idea of “peer buddies” of similar racial and socioeconomic backgrounds to provide support and counseling, while cautioning against overburden these populations. Finally, they propose broadening the sleep provider workforce by training primary care providers to manage OSA.
The higher proportion of nonwhite providers in these groups as compared with sleep specialists may improve care, since concordant race provision has been associated with better communication. Underlying these interventions is the need to diversify representation within the medical field at large.
Swetha Gogineni, MD, Vice-Chair
Lauren Tobias, MD, Member-at-Large
Respiratory-Related Sleep Disorders Section
Reducing racial disparities in sleep apnea
For example, a growing body of research has shown that black race is associated with underdiagnosis of OSA, greater disease severity at time of diagnosis and reduced PAP adherence (Hsu N, et al. J Clin Sleep Med. 2020;16[8]:1249; Thornton JD, et al. Ann Am Thorac Soc. 2022;19[2]:272).
A recent article (Billings ME, et al. Chest. 2021;159[3]:1232) offered potential strategies to mitigate racial disparities in sleep apnea management. To expand access to care, they advocate embracing telemedicine for those who may have difficulty coming to clinic – due to transportation issues, arranging sufficient time off work, or residing in remote locations. On the other hand, an over-reliance on telemedicine has the potential to worsen disparities in populations whose access to technology is limited.
The authors also recommend inpatient screening of high-risk patient populations to detect disease earlier and to help facilitate referrals to a sleep center. They propose the idea of “peer buddies” of similar racial and socioeconomic backgrounds to provide support and counseling, while cautioning against overburden these populations. Finally, they propose broadening the sleep provider workforce by training primary care providers to manage OSA.
The higher proportion of nonwhite providers in these groups as compared with sleep specialists may improve care, since concordant race provision has been associated with better communication. Underlying these interventions is the need to diversify representation within the medical field at large.
Swetha Gogineni, MD, Vice-Chair
Lauren Tobias, MD, Member-at-Large
Respiratory-Related Sleep Disorders Section
Reducing racial disparities in sleep apnea
For example, a growing body of research has shown that black race is associated with underdiagnosis of OSA, greater disease severity at time of diagnosis and reduced PAP adherence (Hsu N, et al. J Clin Sleep Med. 2020;16[8]:1249; Thornton JD, et al. Ann Am Thorac Soc. 2022;19[2]:272).
A recent article (Billings ME, et al. Chest. 2021;159[3]:1232) offered potential strategies to mitigate racial disparities in sleep apnea management. To expand access to care, they advocate embracing telemedicine for those who may have difficulty coming to clinic – due to transportation issues, arranging sufficient time off work, or residing in remote locations. On the other hand, an over-reliance on telemedicine has the potential to worsen disparities in populations whose access to technology is limited.
The authors also recommend inpatient screening of high-risk patient populations to detect disease earlier and to help facilitate referrals to a sleep center. They propose the idea of “peer buddies” of similar racial and socioeconomic backgrounds to provide support and counseling, while cautioning against overburden these populations. Finally, they propose broadening the sleep provider workforce by training primary care providers to manage OSA.
The higher proportion of nonwhite providers in these groups as compared with sleep specialists may improve care, since concordant race provision has been associated with better communication. Underlying these interventions is the need to diversify representation within the medical field at large.
Swetha Gogineni, MD, Vice-Chair
Lauren Tobias, MD, Member-at-Large
Pulmonary Vascular & Cardiovascular Network
Pulmonary Vascular Disease Section
Restoration of RV function in PAH: Is it the holy grail to improve mortality and long-term outcomes?
Despite several therapeutic advances, PAH continues to be associated with high mortality. Even mild increases in mean pulmonary arterial pressure (mPAP) have been shown to directly impact outcomes (Maron BA, et al. Circulation. 2016 Mar 29;133[13]:1240), leading to a change in the hemodynamic definition of PAH (mPAP > 20 mm Hg) at the 2018 World Symposium on Pulmonary Hypertension (WSPH) (Galiè N, et al. Eur Respir J. 2019;53[1]:1801889). The WSPH also recommended a more aggressive and proactive approach to move patients to “low-risk” status.
Elevated mPAP results in increased RV afterload with subsequent RV dysfunction and consequent abnormal remodeling, which is associated with poor outcomes. Reversal of RV remodeling has been demonstrated in patients after PEA for CTEPH and/or lung transplantation for PAH (D’Armini AM, et al. J Thorac Cardiovasc Surg. 2007;133:162).
Aggressive mPAP reduction facilitates RV recovery, which may alter the course of PAH in the form of improved survival. RV dysfunction is mainly attributed to afterload mismatch and uncoupling of the RV. Although oral therapies have shown significant improvements in symptoms, functional class, and delaying clinical worsening, normalization of RV size and function is often not achieved. More aggressive reduction of mPAP with a combination of parenteral and oral therapies has been shown to be more effective in restoring RV function (Vizza CD, et al. Am J Respir Crit Care Med. 2022;205) with the ultimate goal of improving quality and quantity of life in those affected by PAH.
Vijay Balasubramanian, MD, FCCP, Chair
Jean M. Elwing, MD, FCCP, Ex-Officio
Pulmonary Vascular Disease Section
Restoration of RV function in PAH: Is it the holy grail to improve mortality and long-term outcomes?
Despite several therapeutic advances, PAH continues to be associated with high mortality. Even mild increases in mean pulmonary arterial pressure (mPAP) have been shown to directly impact outcomes (Maron BA, et al. Circulation. 2016 Mar 29;133[13]:1240), leading to a change in the hemodynamic definition of PAH (mPAP > 20 mm Hg) at the 2018 World Symposium on Pulmonary Hypertension (WSPH) (Galiè N, et al. Eur Respir J. 2019;53[1]:1801889). The WSPH also recommended a more aggressive and proactive approach to move patients to “low-risk” status.
Elevated mPAP results in increased RV afterload with subsequent RV dysfunction and consequent abnormal remodeling, which is associated with poor outcomes. Reversal of RV remodeling has been demonstrated in patients after PEA for CTEPH and/or lung transplantation for PAH (D’Armini AM, et al. J Thorac Cardiovasc Surg. 2007;133:162).
Aggressive mPAP reduction facilitates RV recovery, which may alter the course of PAH in the form of improved survival. RV dysfunction is mainly attributed to afterload mismatch and uncoupling of the RV. Although oral therapies have shown significant improvements in symptoms, functional class, and delaying clinical worsening, normalization of RV size and function is often not achieved. More aggressive reduction of mPAP with a combination of parenteral and oral therapies has been shown to be more effective in restoring RV function (Vizza CD, et al. Am J Respir Crit Care Med. 2022;205) with the ultimate goal of improving quality and quantity of life in those affected by PAH.
Vijay Balasubramanian, MD, FCCP, Chair
Jean M. Elwing, MD, FCCP, Ex-Officio
Pulmonary Vascular Disease Section
Restoration of RV function in PAH: Is it the holy grail to improve mortality and long-term outcomes?
Despite several therapeutic advances, PAH continues to be associated with high mortality. Even mild increases in mean pulmonary arterial pressure (mPAP) have been shown to directly impact outcomes (Maron BA, et al. Circulation. 2016 Mar 29;133[13]:1240), leading to a change in the hemodynamic definition of PAH (mPAP > 20 mm Hg) at the 2018 World Symposium on Pulmonary Hypertension (WSPH) (Galiè N, et al. Eur Respir J. 2019;53[1]:1801889). The WSPH also recommended a more aggressive and proactive approach to move patients to “low-risk” status.
Elevated mPAP results in increased RV afterload with subsequent RV dysfunction and consequent abnormal remodeling, which is associated with poor outcomes. Reversal of RV remodeling has been demonstrated in patients after PEA for CTEPH and/or lung transplantation for PAH (D’Armini AM, et al. J Thorac Cardiovasc Surg. 2007;133:162).
Aggressive mPAP reduction facilitates RV recovery, which may alter the course of PAH in the form of improved survival. RV dysfunction is mainly attributed to afterload mismatch and uncoupling of the RV. Although oral therapies have shown significant improvements in symptoms, functional class, and delaying clinical worsening, normalization of RV size and function is often not achieved. More aggressive reduction of mPAP with a combination of parenteral and oral therapies has been shown to be more effective in restoring RV function (Vizza CD, et al. Am J Respir Crit Care Med. 2022;205) with the ultimate goal of improving quality and quantity of life in those affected by PAH.
Vijay Balasubramanian, MD, FCCP, Chair
Jean M. Elwing, MD, FCCP, Ex-Officio
Thoracic Oncology & Chest Procedures Network
Interventional Procedures Section
Lung cancer is the leading cause of cancer-related deaths worldwide and forms of a large burden of cancer-related mortality in the United States. With the rapid advent of new disease-directed therapy, including molecular and targeted therapies, the outlook for management of lung cancer has changed dramatically over the last decade. The choice of therapy, as well as prognosis, is dependent on the stage at diagnosis. It is thus imperative that we accurately differentiate between stages I, II, and III disease by assessment of hilar and mediastinal lymph nodes.
Traditionally, CT and PET/CT scans have been the mainstay to assess stage, with patients with abnormal lymph nodes or high risk of nodal metastasis (≥ T2 disease or “central” location) undergoing invasive mediastinal evaluation (Silvestri, et al. Chest. 2013 May;143(5 Suppl):e211S). The decision to perform invasive mediastinal staging for T1 tumors remains a matter of discussion. DuComb and colleagues, in their study demonstrated a high rate of N2 metastasis (8.1%) even amongst those with T1 tumors, which was independent of tumor location (DuComb, et al. Chest. 2020 Nov;158[5]:2192). This rate is consistent with previous reported rates ranging from 6.9% to 13% of N2 disease in patients with no radiographic evidence of lymph node metastasis (Gonzalez-Stawinski, et al. J Thorac Cardiovasc Surg. 2003 Dec;126[6]:1900; Bao, et al. J Thorac Dis. 2014;6[12]:1697; Shin, et al. Eur Respir J. 2019;53[3]:1801508). The above indicates a possible role of invasive mediastinal staging using EBUS-TBNA in patients with T1 disease to accurately stage the disease prior to curative intent treatment.
While the role of EBUS-TBNA in diagnosis and staging has been a role of ongoing research, data are limited on prognostic implications of EBUS-guided staging in patients with NSCLC. In a recently published paper in Chest, Hwangbo and colleagues assessed the prognostic impact of staging via EBUS in these patients (Hwangbo et al. Chest 2022 May;161[5]:1382). In the 1,089 patients who underwent EBUS-TBNA, they observed a significant difference in survival based on the staging established via EBUS-TBNA, highlighting the importance of EBUS-TBNA in staging for NSCLC. Also of note, patients with false-negative EBUS results had favorable survival that was similar to patients with pathologic N1 disease. While the exact reason for this is unclear and may be related to disease burden, the authors postulated that this may provide a rationale to performing surgery after negative EBUS-TBNA results.
Abhinav Agrawal, MD, FCCP, Member-at-Large
Ellen Volker, MD, MSPH, FCCP, Member-at-Large
Interventional Procedures Section
Lung cancer is the leading cause of cancer-related deaths worldwide and forms of a large burden of cancer-related mortality in the United States. With the rapid advent of new disease-directed therapy, including molecular and targeted therapies, the outlook for management of lung cancer has changed dramatically over the last decade. The choice of therapy, as well as prognosis, is dependent on the stage at diagnosis. It is thus imperative that we accurately differentiate between stages I, II, and III disease by assessment of hilar and mediastinal lymph nodes.
Traditionally, CT and PET/CT scans have been the mainstay to assess stage, with patients with abnormal lymph nodes or high risk of nodal metastasis (≥ T2 disease or “central” location) undergoing invasive mediastinal evaluation (Silvestri, et al. Chest. 2013 May;143(5 Suppl):e211S). The decision to perform invasive mediastinal staging for T1 tumors remains a matter of discussion. DuComb and colleagues, in their study demonstrated a high rate of N2 metastasis (8.1%) even amongst those with T1 tumors, which was independent of tumor location (DuComb, et al. Chest. 2020 Nov;158[5]:2192). This rate is consistent with previous reported rates ranging from 6.9% to 13% of N2 disease in patients with no radiographic evidence of lymph node metastasis (Gonzalez-Stawinski, et al. J Thorac Cardiovasc Surg. 2003 Dec;126[6]:1900; Bao, et al. J Thorac Dis. 2014;6[12]:1697; Shin, et al. Eur Respir J. 2019;53[3]:1801508). The above indicates a possible role of invasive mediastinal staging using EBUS-TBNA in patients with T1 disease to accurately stage the disease prior to curative intent treatment.
While the role of EBUS-TBNA in diagnosis and staging has been a role of ongoing research, data are limited on prognostic implications of EBUS-guided staging in patients with NSCLC. In a recently published paper in Chest, Hwangbo and colleagues assessed the prognostic impact of staging via EBUS in these patients (Hwangbo et al. Chest 2022 May;161[5]:1382). In the 1,089 patients who underwent EBUS-TBNA, they observed a significant difference in survival based on the staging established via EBUS-TBNA, highlighting the importance of EBUS-TBNA in staging for NSCLC. Also of note, patients with false-negative EBUS results had favorable survival that was similar to patients with pathologic N1 disease. While the exact reason for this is unclear and may be related to disease burden, the authors postulated that this may provide a rationale to performing surgery after negative EBUS-TBNA results.
Abhinav Agrawal, MD, FCCP, Member-at-Large
Ellen Volker, MD, MSPH, FCCP, Member-at-Large
Interventional Procedures Section
Lung cancer is the leading cause of cancer-related deaths worldwide and forms of a large burden of cancer-related mortality in the United States. With the rapid advent of new disease-directed therapy, including molecular and targeted therapies, the outlook for management of lung cancer has changed dramatically over the last decade. The choice of therapy, as well as prognosis, is dependent on the stage at diagnosis. It is thus imperative that we accurately differentiate between stages I, II, and III disease by assessment of hilar and mediastinal lymph nodes.
Traditionally, CT and PET/CT scans have been the mainstay to assess stage, with patients with abnormal lymph nodes or high risk of nodal metastasis (≥ T2 disease or “central” location) undergoing invasive mediastinal evaluation (Silvestri, et al. Chest. 2013 May;143(5 Suppl):e211S). The decision to perform invasive mediastinal staging for T1 tumors remains a matter of discussion. DuComb and colleagues, in their study demonstrated a high rate of N2 metastasis (8.1%) even amongst those with T1 tumors, which was independent of tumor location (DuComb, et al. Chest. 2020 Nov;158[5]:2192). This rate is consistent with previous reported rates ranging from 6.9% to 13% of N2 disease in patients with no radiographic evidence of lymph node metastasis (Gonzalez-Stawinski, et al. J Thorac Cardiovasc Surg. 2003 Dec;126[6]:1900; Bao, et al. J Thorac Dis. 2014;6[12]:1697; Shin, et al. Eur Respir J. 2019;53[3]:1801508). The above indicates a possible role of invasive mediastinal staging using EBUS-TBNA in patients with T1 disease to accurately stage the disease prior to curative intent treatment.
While the role of EBUS-TBNA in diagnosis and staging has been a role of ongoing research, data are limited on prognostic implications of EBUS-guided staging in patients with NSCLC. In a recently published paper in Chest, Hwangbo and colleagues assessed the prognostic impact of staging via EBUS in these patients (Hwangbo et al. Chest 2022 May;161[5]:1382). In the 1,089 patients who underwent EBUS-TBNA, they observed a significant difference in survival based on the staging established via EBUS-TBNA, highlighting the importance of EBUS-TBNA in staging for NSCLC. Also of note, patients with false-negative EBUS results had favorable survival that was similar to patients with pathologic N1 disease. While the exact reason for this is unclear and may be related to disease burden, the authors postulated that this may provide a rationale to performing surgery after negative EBUS-TBNA results.
Abhinav Agrawal, MD, FCCP, Member-at-Large
Ellen Volker, MD, MSPH, FCCP, Member-at-Large
Chest Infections & Disaster Response Network
Disaster Response and Global Health Section
Physician response to Ukraine and beyond
Displaced persons, international refugee crises, gun violence, and other disasters remain prevalent in current news. Recent events highlight the need for continued civilian physician leadership and response to disasters.
Before the Ukraine crisis, the United Nations Refugee Agency estimated displaced persons more than doubled to greater than 82 million persons over the last decade (unhcr.org). Since that analysis, there have been over 6.5 million externally displaced persons, 7.5 million internally displaced persons, and significant numbers of injured patients from the Ukraine crisis alone. The Ukraine Ministry of Health has shown preparedness in its ability to handle significant patient surges with minimal assistance.
However, organizations like the Ukraine Medical Association of North America, Razom for Ukraine, Doctors Without Borders (MSF), MedGlobal, Samaritan’s Purse, Global Response Management, and many more have deployed to assist in Ukraine. These NGOs continue to help with medical care, fulfill critical supply needs, and provide training in cutting-edge medicine (POCUS, trauma updates).
Challenges posed by unstable environments, from wars to active shooter situations, further underscore the need for continued education, advances in technology, and preparedness. Providers responding to these events often treat vulnerable populations suffering from physical and mental violence, requiring physicians to step out of their comfort zone.
Physicians should continue to be leaders in the care of vulnerable displaced persons.
Christopher Miller, DO, MPH
Fellow-in-Training Member
Thomas Marston, MD
Member-at-Large
Disaster Response and Global Health Section
Physician response to Ukraine and beyond
Displaced persons, international refugee crises, gun violence, and other disasters remain prevalent in current news. Recent events highlight the need for continued civilian physician leadership and response to disasters.
Before the Ukraine crisis, the United Nations Refugee Agency estimated displaced persons more than doubled to greater than 82 million persons over the last decade (unhcr.org). Since that analysis, there have been over 6.5 million externally displaced persons, 7.5 million internally displaced persons, and significant numbers of injured patients from the Ukraine crisis alone. The Ukraine Ministry of Health has shown preparedness in its ability to handle significant patient surges with minimal assistance.
However, organizations like the Ukraine Medical Association of North America, Razom for Ukraine, Doctors Without Borders (MSF), MedGlobal, Samaritan’s Purse, Global Response Management, and many more have deployed to assist in Ukraine. These NGOs continue to help with medical care, fulfill critical supply needs, and provide training in cutting-edge medicine (POCUS, trauma updates).
Challenges posed by unstable environments, from wars to active shooter situations, further underscore the need for continued education, advances in technology, and preparedness. Providers responding to these events often treat vulnerable populations suffering from physical and mental violence, requiring physicians to step out of their comfort zone.
Physicians should continue to be leaders in the care of vulnerable displaced persons.
Christopher Miller, DO, MPH
Fellow-in-Training Member
Thomas Marston, MD
Member-at-Large
Disaster Response and Global Health Section
Physician response to Ukraine and beyond
Displaced persons, international refugee crises, gun violence, and other disasters remain prevalent in current news. Recent events highlight the need for continued civilian physician leadership and response to disasters.
Before the Ukraine crisis, the United Nations Refugee Agency estimated displaced persons more than doubled to greater than 82 million persons over the last decade (unhcr.org). Since that analysis, there have been over 6.5 million externally displaced persons, 7.5 million internally displaced persons, and significant numbers of injured patients from the Ukraine crisis alone. The Ukraine Ministry of Health has shown preparedness in its ability to handle significant patient surges with minimal assistance.
However, organizations like the Ukraine Medical Association of North America, Razom for Ukraine, Doctors Without Borders (MSF), MedGlobal, Samaritan’s Purse, Global Response Management, and many more have deployed to assist in Ukraine. These NGOs continue to help with medical care, fulfill critical supply needs, and provide training in cutting-edge medicine (POCUS, trauma updates).
Challenges posed by unstable environments, from wars to active shooter situations, further underscore the need for continued education, advances in technology, and preparedness. Providers responding to these events often treat vulnerable populations suffering from physical and mental violence, requiring physicians to step out of their comfort zone.
Physicians should continue to be leaders in the care of vulnerable displaced persons.
Christopher Miller, DO, MPH
Fellow-in-Training Member
Thomas Marston, MD
Member-at-Large
Early childhood allergies linked with ADHD and ASD
“Our study provides strong evidence for the association between allergic disorders in early childhood and the development of ADHD,” Shay Nemet, MD, of the Kaplan Medical Center, Rehovot, Israel, and colleagues write in Pediatric Allergy and Immunology. “The risk of those children to develop ASD was less significant.”
The researchers analyzed data from 117,022 consecutive children diagnosed with at least one allergic disorder – asthma, conjunctivitis, rhinitis, and drug, food, or skin allergy – and 116,968 children without allergies in the Clalit Health Services pediatric database. The children had been treated from 2000 to 2018; the mean follow-up period was 11 years.
The children who were diagnosed with one or more allergies (mean age, 4.5 years) were significantly more likely to develop ADHD (odds ratio, 2.45; 95% confidence interval, 2.39-2.51), ASD (OR, 1.17; 95% CI, 1.08-1.27), or both ADHD and ASD (OR, 1.56; 95% CI, 1.35-1.79) than were the control children who did not have allergies.
Children diagnosed with rhinitis (OR, 3.96; 95% CI, 3.80-4.12) and conjunctivitis (OR, 3.63; 95% CI, 3.53-3.74) were the most likely to develop ADHD.
Allergy correlation with ADHD and ASD
Cy B. Nadler, PhD, a clinical psychologist and the director of Autism Services at Children’s Mercy Kansas City, Missouri, told this news organization that children and adults with neurodevelopmental differences are also more likely to have other health problems.
“Clinicians practicing in subspecialties such as allergy and immunology may have opportunities to help psychologists identify developmental and behavioral concerns early in childhood,” he added.
“Studies like this can’t be accomplished without large health care databases, but this approach has drawbacks, too,” Dr. Nadler said in an email. “Without more information about these patients’ co-occurring medical and behavioral conditions, we are almost certainly missing important contributors to the observed associations.”
Dr. Nadler, who was not involved in the study, noted that in the multivariable analysis that controlled for age at study entry, gender, and number of annual visits, the link between allergy and ASD diagnosis was not significant.
“It is important to remember not to interpret these study results as causal,” he added.
Desha M. Jordan, MD, FAAP, an assistant professor of pediatrics at UPMC Children’s Hospital of Pittsburgh, called the study “an interesting new area that has been speculated about for some time” and “one of the first I have seen with statistically significant correlations found between ADHD, ASD, and allergic conditions.”
More questions for future studies
Health care providers need to understand the potential sequelae of allergic conditions so that they can manage their patients appropriately, she advised.
Although symptoms and diagnoses were confirmed for all patients, the study’s retrospective design and the possibility of recall bias were limitations, said Dr. Jordan in an email. She also was not involved in the study.
“For example, the family of a child diagnosed with ADHD or ASD may have been more mindful of anything out of the norm in that child’s past, while the family of a child without these conditions may not have recalled allergic symptoms as important,” she explained.
Another question that arises is whether some patients were treated and managed well while others were not and whether this disparity in care affected the development or severity of ADHD or ASD, she added.
“Is a patient with a well-controlled allergic condition less likely to develop ADHD or ASD than a patient with an uncontrolled allergic condition? Does a well-controlled patient ever return to the same probability of getting ADHD or ASD as a nonallergic patient?”
“While this study expands our understanding of these conditions and their interrelationships, it also brings up many additional questions and opens a new segment of research,” Dr. Jordan said. “More studies in this area are necessary to confirm the findings of this paper.”
The study was partially funded by the Israel Ambulatory Pediatric Association. The authors, Dr. Nadler, and Dr. Jordan report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“Our study provides strong evidence for the association between allergic disorders in early childhood and the development of ADHD,” Shay Nemet, MD, of the Kaplan Medical Center, Rehovot, Israel, and colleagues write in Pediatric Allergy and Immunology. “The risk of those children to develop ASD was less significant.”
The researchers analyzed data from 117,022 consecutive children diagnosed with at least one allergic disorder – asthma, conjunctivitis, rhinitis, and drug, food, or skin allergy – and 116,968 children without allergies in the Clalit Health Services pediatric database. The children had been treated from 2000 to 2018; the mean follow-up period was 11 years.
The children who were diagnosed with one or more allergies (mean age, 4.5 years) were significantly more likely to develop ADHD (odds ratio, 2.45; 95% confidence interval, 2.39-2.51), ASD (OR, 1.17; 95% CI, 1.08-1.27), or both ADHD and ASD (OR, 1.56; 95% CI, 1.35-1.79) than were the control children who did not have allergies.
Children diagnosed with rhinitis (OR, 3.96; 95% CI, 3.80-4.12) and conjunctivitis (OR, 3.63; 95% CI, 3.53-3.74) were the most likely to develop ADHD.
Allergy correlation with ADHD and ASD
Cy B. Nadler, PhD, a clinical psychologist and the director of Autism Services at Children’s Mercy Kansas City, Missouri, told this news organization that children and adults with neurodevelopmental differences are also more likely to have other health problems.
“Clinicians practicing in subspecialties such as allergy and immunology may have opportunities to help psychologists identify developmental and behavioral concerns early in childhood,” he added.
“Studies like this can’t be accomplished without large health care databases, but this approach has drawbacks, too,” Dr. Nadler said in an email. “Without more information about these patients’ co-occurring medical and behavioral conditions, we are almost certainly missing important contributors to the observed associations.”
Dr. Nadler, who was not involved in the study, noted that in the multivariable analysis that controlled for age at study entry, gender, and number of annual visits, the link between allergy and ASD diagnosis was not significant.
“It is important to remember not to interpret these study results as causal,” he added.
Desha M. Jordan, MD, FAAP, an assistant professor of pediatrics at UPMC Children’s Hospital of Pittsburgh, called the study “an interesting new area that has been speculated about for some time” and “one of the first I have seen with statistically significant correlations found between ADHD, ASD, and allergic conditions.”
More questions for future studies
Health care providers need to understand the potential sequelae of allergic conditions so that they can manage their patients appropriately, she advised.
Although symptoms and diagnoses were confirmed for all patients, the study’s retrospective design and the possibility of recall bias were limitations, said Dr. Jordan in an email. She also was not involved in the study.
“For example, the family of a child diagnosed with ADHD or ASD may have been more mindful of anything out of the norm in that child’s past, while the family of a child without these conditions may not have recalled allergic symptoms as important,” she explained.
Another question that arises is whether some patients were treated and managed well while others were not and whether this disparity in care affected the development or severity of ADHD or ASD, she added.
“Is a patient with a well-controlled allergic condition less likely to develop ADHD or ASD than a patient with an uncontrolled allergic condition? Does a well-controlled patient ever return to the same probability of getting ADHD or ASD as a nonallergic patient?”
“While this study expands our understanding of these conditions and their interrelationships, it also brings up many additional questions and opens a new segment of research,” Dr. Jordan said. “More studies in this area are necessary to confirm the findings of this paper.”
The study was partially funded by the Israel Ambulatory Pediatric Association. The authors, Dr. Nadler, and Dr. Jordan report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“Our study provides strong evidence for the association between allergic disorders in early childhood and the development of ADHD,” Shay Nemet, MD, of the Kaplan Medical Center, Rehovot, Israel, and colleagues write in Pediatric Allergy and Immunology. “The risk of those children to develop ASD was less significant.”
The researchers analyzed data from 117,022 consecutive children diagnosed with at least one allergic disorder – asthma, conjunctivitis, rhinitis, and drug, food, or skin allergy – and 116,968 children without allergies in the Clalit Health Services pediatric database. The children had been treated from 2000 to 2018; the mean follow-up period was 11 years.
The children who were diagnosed with one or more allergies (mean age, 4.5 years) were significantly more likely to develop ADHD (odds ratio, 2.45; 95% confidence interval, 2.39-2.51), ASD (OR, 1.17; 95% CI, 1.08-1.27), or both ADHD and ASD (OR, 1.56; 95% CI, 1.35-1.79) than were the control children who did not have allergies.
Children diagnosed with rhinitis (OR, 3.96; 95% CI, 3.80-4.12) and conjunctivitis (OR, 3.63; 95% CI, 3.53-3.74) were the most likely to develop ADHD.
Allergy correlation with ADHD and ASD
Cy B. Nadler, PhD, a clinical psychologist and the director of Autism Services at Children’s Mercy Kansas City, Missouri, told this news organization that children and adults with neurodevelopmental differences are also more likely to have other health problems.
“Clinicians practicing in subspecialties such as allergy and immunology may have opportunities to help psychologists identify developmental and behavioral concerns early in childhood,” he added.
“Studies like this can’t be accomplished without large health care databases, but this approach has drawbacks, too,” Dr. Nadler said in an email. “Without more information about these patients’ co-occurring medical and behavioral conditions, we are almost certainly missing important contributors to the observed associations.”
Dr. Nadler, who was not involved in the study, noted that in the multivariable analysis that controlled for age at study entry, gender, and number of annual visits, the link between allergy and ASD diagnosis was not significant.
“It is important to remember not to interpret these study results as causal,” he added.
Desha M. Jordan, MD, FAAP, an assistant professor of pediatrics at UPMC Children’s Hospital of Pittsburgh, called the study “an interesting new area that has been speculated about for some time” and “one of the first I have seen with statistically significant correlations found between ADHD, ASD, and allergic conditions.”
More questions for future studies
Health care providers need to understand the potential sequelae of allergic conditions so that they can manage their patients appropriately, she advised.
Although symptoms and diagnoses were confirmed for all patients, the study’s retrospective design and the possibility of recall bias were limitations, said Dr. Jordan in an email. She also was not involved in the study.
“For example, the family of a child diagnosed with ADHD or ASD may have been more mindful of anything out of the norm in that child’s past, while the family of a child without these conditions may not have recalled allergic symptoms as important,” she explained.
Another question that arises is whether some patients were treated and managed well while others were not and whether this disparity in care affected the development or severity of ADHD or ASD, she added.
“Is a patient with a well-controlled allergic condition less likely to develop ADHD or ASD than a patient with an uncontrolled allergic condition? Does a well-controlled patient ever return to the same probability of getting ADHD or ASD as a nonallergic patient?”
“While this study expands our understanding of these conditions and their interrelationships, it also brings up many additional questions and opens a new segment of research,” Dr. Jordan said. “More studies in this area are necessary to confirm the findings of this paper.”
The study was partially funded by the Israel Ambulatory Pediatric Association. The authors, Dr. Nadler, and Dr. Jordan report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM PEDIATRIC ALLERGY AND IMMUNOLOGY
WHO tracking new Omicron subvariant in India
The subvariant, a sublineage of BA.2 being called BA.2.75, has been reported in eight countries and hasn’t yet been declared a variant of concern.
“There’s been an emergence of a ‘could be’ subvariant. It’s been not yet officially called, but some people are referring to it as BA.2.75,” Soumya Swaminathan, MD, the WHO’s chief scientist, said in a video posted on Twitter.
The subvariant appears to have mutations similar to other contagious strains, she said, though there are a limited number of sequences available to analyze. How transmissible and severe it is, and how well it can evade our immunity, aren’t yet known.
“We have to wait and see, and of course, we are tracking it,” Dr. Swaminathan said.
The WHO committee responsible for analyzing global coronavirus data will label the subvariant officially and release more information as the situation warrants it, she said.
Public health experts around the world are also talking about the subvariant, which has been nicknamed Centaurus. BA.2.75 was first found in India in May and is now competing with BA.5, which has become dominant in the United States.
BA.2.75 has eight mutations beyond those seen in BA.5, which “could make immune escape worse than what we’re seeing now,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute and editor-in-chief at Medscape, wrote in a Twitter post.
Individually, the extra mutations aren’t too concerning, “but all appearing together at once is another matter,” Tom Peacock, PhD, a virologist at Imperial College London, wrote in a Twitter post.
The “apparent rapid growth and wide geographical spread” are “worth keeping a close eye on,” he said.
BA.2.75 has been found in a handful of cases in the United States, Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom. In India, the sequence accounts for about 23% of recent samples.
“It is really too early to know if BA.2.75 will take over relative to BA.2 or even relative to BA.5,” Ulrich Elling, PhD, a researcher at Australia’s Institute of Molecular Biotechnology, wrote in a Twitter post.
“Just to emphasize it again: While the distribution across Indian regions as well as internationally and the very rapid appearance makes it likely we are dealing with a variant spreading fast and spread widely already, the absolute data points are few,” he said.
Globally, coronavirus cases have increased nearly 30% during the past 2 weeks, the WHO said July 6. Four out of six of the WHO subregions reported an increase in the last week, with BA.4 and BA.5 driving waves in the United States and Europe.
A version of this article first appeared on WebMD.com.
The subvariant, a sublineage of BA.2 being called BA.2.75, has been reported in eight countries and hasn’t yet been declared a variant of concern.
“There’s been an emergence of a ‘could be’ subvariant. It’s been not yet officially called, but some people are referring to it as BA.2.75,” Soumya Swaminathan, MD, the WHO’s chief scientist, said in a video posted on Twitter.
The subvariant appears to have mutations similar to other contagious strains, she said, though there are a limited number of sequences available to analyze. How transmissible and severe it is, and how well it can evade our immunity, aren’t yet known.
“We have to wait and see, and of course, we are tracking it,” Dr. Swaminathan said.
The WHO committee responsible for analyzing global coronavirus data will label the subvariant officially and release more information as the situation warrants it, she said.
Public health experts around the world are also talking about the subvariant, which has been nicknamed Centaurus. BA.2.75 was first found in India in May and is now competing with BA.5, which has become dominant in the United States.
BA.2.75 has eight mutations beyond those seen in BA.5, which “could make immune escape worse than what we’re seeing now,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute and editor-in-chief at Medscape, wrote in a Twitter post.
Individually, the extra mutations aren’t too concerning, “but all appearing together at once is another matter,” Tom Peacock, PhD, a virologist at Imperial College London, wrote in a Twitter post.
The “apparent rapid growth and wide geographical spread” are “worth keeping a close eye on,” he said.
BA.2.75 has been found in a handful of cases in the United States, Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom. In India, the sequence accounts for about 23% of recent samples.
“It is really too early to know if BA.2.75 will take over relative to BA.2 or even relative to BA.5,” Ulrich Elling, PhD, a researcher at Australia’s Institute of Molecular Biotechnology, wrote in a Twitter post.
“Just to emphasize it again: While the distribution across Indian regions as well as internationally and the very rapid appearance makes it likely we are dealing with a variant spreading fast and spread widely already, the absolute data points are few,” he said.
Globally, coronavirus cases have increased nearly 30% during the past 2 weeks, the WHO said July 6. Four out of six of the WHO subregions reported an increase in the last week, with BA.4 and BA.5 driving waves in the United States and Europe.
A version of this article first appeared on WebMD.com.
The subvariant, a sublineage of BA.2 being called BA.2.75, has been reported in eight countries and hasn’t yet been declared a variant of concern.
“There’s been an emergence of a ‘could be’ subvariant. It’s been not yet officially called, but some people are referring to it as BA.2.75,” Soumya Swaminathan, MD, the WHO’s chief scientist, said in a video posted on Twitter.
The subvariant appears to have mutations similar to other contagious strains, she said, though there are a limited number of sequences available to analyze. How transmissible and severe it is, and how well it can evade our immunity, aren’t yet known.
“We have to wait and see, and of course, we are tracking it,” Dr. Swaminathan said.
The WHO committee responsible for analyzing global coronavirus data will label the subvariant officially and release more information as the situation warrants it, she said.
Public health experts around the world are also talking about the subvariant, which has been nicknamed Centaurus. BA.2.75 was first found in India in May and is now competing with BA.5, which has become dominant in the United States.
BA.2.75 has eight mutations beyond those seen in BA.5, which “could make immune escape worse than what we’re seeing now,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute and editor-in-chief at Medscape, wrote in a Twitter post.
Individually, the extra mutations aren’t too concerning, “but all appearing together at once is another matter,” Tom Peacock, PhD, a virologist at Imperial College London, wrote in a Twitter post.
The “apparent rapid growth and wide geographical spread” are “worth keeping a close eye on,” he said.
BA.2.75 has been found in a handful of cases in the United States, Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom. In India, the sequence accounts for about 23% of recent samples.
“It is really too early to know if BA.2.75 will take over relative to BA.2 or even relative to BA.5,” Ulrich Elling, PhD, a researcher at Australia’s Institute of Molecular Biotechnology, wrote in a Twitter post.
“Just to emphasize it again: While the distribution across Indian regions as well as internationally and the very rapid appearance makes it likely we are dealing with a variant spreading fast and spread widely already, the absolute data points are few,” he said.
Globally, coronavirus cases have increased nearly 30% during the past 2 weeks, the WHO said July 6. Four out of six of the WHO subregions reported an increase in the last week, with BA.4 and BA.5 driving waves in the United States and Europe.
A version of this article first appeared on WebMD.com.
Experimental cancer drug promising for hospitalized COVID patients
study shows.
, a newThe medication, called sabizabulin and given as a pill, reduced by half the risk of death among participants. It could be more effective than other drugs for those severely sick with COVID-19, The New York Times reports.
The manufacturer, Veru, is seeking emergency use authorization from the Food and Drug Administration. Hospitalized COVID-19 patients currently have only a few pharmaceutical options.
Sabizabulin blocks cells from building molecular cables that carry material from one part of a cell to another. It was created to fight cancer, because tumor cells need those cables (called microtubules) to grow quickly.
Researchers tried it against COVID-19 2 years ago, because viral replication also requires microtubules to bring pieces of new viruses together.
To participate in the small trial, patients had to be receiving oxygen or on a ventilator and at a high risk of dying from COVID-19, “with risk factors such as hypertension, advanced age or obesity,” the Times reported.
A total of 134 patients received the medicine; 70 got a placebo. Among those receiving sabizabulin, 20.2% died within 2 months; 45.1% of those who took the placebo died.
One infectious disease expert told the Times that the high mortality rate of those on the placebo could mean the study was too small to offer conclusive results.
“The 45% mortality rate in the control group jumps out at me as rather high,” said David Boulware, MD, of the University of Minnesota.
A version of this article first appeared on WebMD.com.
study shows.
, a newThe medication, called sabizabulin and given as a pill, reduced by half the risk of death among participants. It could be more effective than other drugs for those severely sick with COVID-19, The New York Times reports.
The manufacturer, Veru, is seeking emergency use authorization from the Food and Drug Administration. Hospitalized COVID-19 patients currently have only a few pharmaceutical options.
Sabizabulin blocks cells from building molecular cables that carry material from one part of a cell to another. It was created to fight cancer, because tumor cells need those cables (called microtubules) to grow quickly.
Researchers tried it against COVID-19 2 years ago, because viral replication also requires microtubules to bring pieces of new viruses together.
To participate in the small trial, patients had to be receiving oxygen or on a ventilator and at a high risk of dying from COVID-19, “with risk factors such as hypertension, advanced age or obesity,” the Times reported.
A total of 134 patients received the medicine; 70 got a placebo. Among those receiving sabizabulin, 20.2% died within 2 months; 45.1% of those who took the placebo died.
One infectious disease expert told the Times that the high mortality rate of those on the placebo could mean the study was too small to offer conclusive results.
“The 45% mortality rate in the control group jumps out at me as rather high,” said David Boulware, MD, of the University of Minnesota.
A version of this article first appeared on WebMD.com.
study shows.
, a newThe medication, called sabizabulin and given as a pill, reduced by half the risk of death among participants. It could be more effective than other drugs for those severely sick with COVID-19, The New York Times reports.
The manufacturer, Veru, is seeking emergency use authorization from the Food and Drug Administration. Hospitalized COVID-19 patients currently have only a few pharmaceutical options.
Sabizabulin blocks cells from building molecular cables that carry material from one part of a cell to another. It was created to fight cancer, because tumor cells need those cables (called microtubules) to grow quickly.
Researchers tried it against COVID-19 2 years ago, because viral replication also requires microtubules to bring pieces of new viruses together.
To participate in the small trial, patients had to be receiving oxygen or on a ventilator and at a high risk of dying from COVID-19, “with risk factors such as hypertension, advanced age or obesity,” the Times reported.
A total of 134 patients received the medicine; 70 got a placebo. Among those receiving sabizabulin, 20.2% died within 2 months; 45.1% of those who took the placebo died.
One infectious disease expert told the Times that the high mortality rate of those on the placebo could mean the study was too small to offer conclusive results.
“The 45% mortality rate in the control group jumps out at me as rather high,” said David Boulware, MD, of the University of Minnesota.
A version of this article first appeared on WebMD.com.
CDC recommends high-dose flu vaccines for seniors
In an online statement Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluad Quadrivalent flu vaccines are among those specified in the release.
The organization says that these higher-dose vaccines may be more effective for the aging population, who often have difficulty mounting a strong enough immune response to protect themselves against the flu virus. People older than 65 years struggle the most during flu season and have the highest proportion of hospitalizations and deaths from flu, according to the release.
But the CDC believes that higher-dose vaccines have the potential to better protect against that danger. One study, from The New England Journal of Medicine, reported that high-dose/adjuvanted vaccines prevented flu in older patients 24% better than did lower-dose/nonadjuvanted vaccines.
These types of vaccines work by creating a larger immune response than a standard vaccine dose. In particular, adjuvanted vaccines contain an extra ingredient within them that helps the immune system produce a stronger reaction to the vaccine. These may be things like aluminum salts, which signal the body to respond faster. Higher-dose vaccines similarly promote a stronger immune response by having more particles of the target virus in their mixture. In theory, this means the body will create an enhanced response to the vaccine. For example, a higher-dose vaccine may quadruple the amount of antigens, compared with the standard dose.
The hope is that this recommendation may increase vaccine use across the board, says José Romero, MD, the director of the CDC’s National Center for Immunization and Respiratory Diseases. As quoted in the CDC announcement, Dr. Romero said that this may help reduce racial inequities in access to flu vaccines. A 2019 meta-analysis concluded that Black and Hispanic people are around 30%-40% less likely to get the flu vaccine. So increasing the access to this medication “could help reduce health disparities by making these vaccines more available to racial and ethnic minority groups,” said Dr. Romero.
The decision, spearheaded by CDC Director Rochelle Walensky, MD, follows recommendations from the Advisory Committee on Immunization Practices, which presented on this topic during a June 22 meeting. It is now part of official CDC policy and will continue to be developed as the 2022-2023 flu season approaches.
In addition, the organization says they’ll reveal more details for their plan later this summer, in their Morbidity and Mortality Weekly Report (MMWR). For now, seniors should know that they should try to get the recommended high-dose vaccines, but if they can’t, then a standard dose of whatever their provider has on hand will do.
At this point, there is still no specific vaccine recommendation for people aged under 65 years. The CDC historically avoids specifying one type of vaccine over another and says each should still be effective in younger patients.
A version of this article first appeared on Medscape.com.
In an online statement Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluad Quadrivalent flu vaccines are among those specified in the release.
The organization says that these higher-dose vaccines may be more effective for the aging population, who often have difficulty mounting a strong enough immune response to protect themselves against the flu virus. People older than 65 years struggle the most during flu season and have the highest proportion of hospitalizations and deaths from flu, according to the release.
But the CDC believes that higher-dose vaccines have the potential to better protect against that danger. One study, from The New England Journal of Medicine, reported that high-dose/adjuvanted vaccines prevented flu in older patients 24% better than did lower-dose/nonadjuvanted vaccines.
These types of vaccines work by creating a larger immune response than a standard vaccine dose. In particular, adjuvanted vaccines contain an extra ingredient within them that helps the immune system produce a stronger reaction to the vaccine. These may be things like aluminum salts, which signal the body to respond faster. Higher-dose vaccines similarly promote a stronger immune response by having more particles of the target virus in their mixture. In theory, this means the body will create an enhanced response to the vaccine. For example, a higher-dose vaccine may quadruple the amount of antigens, compared with the standard dose.
The hope is that this recommendation may increase vaccine use across the board, says José Romero, MD, the director of the CDC’s National Center for Immunization and Respiratory Diseases. As quoted in the CDC announcement, Dr. Romero said that this may help reduce racial inequities in access to flu vaccines. A 2019 meta-analysis concluded that Black and Hispanic people are around 30%-40% less likely to get the flu vaccine. So increasing the access to this medication “could help reduce health disparities by making these vaccines more available to racial and ethnic minority groups,” said Dr. Romero.
The decision, spearheaded by CDC Director Rochelle Walensky, MD, follows recommendations from the Advisory Committee on Immunization Practices, which presented on this topic during a June 22 meeting. It is now part of official CDC policy and will continue to be developed as the 2022-2023 flu season approaches.
In addition, the organization says they’ll reveal more details for their plan later this summer, in their Morbidity and Mortality Weekly Report (MMWR). For now, seniors should know that they should try to get the recommended high-dose vaccines, but if they can’t, then a standard dose of whatever their provider has on hand will do.
At this point, there is still no specific vaccine recommendation for people aged under 65 years. The CDC historically avoids specifying one type of vaccine over another and says each should still be effective in younger patients.
A version of this article first appeared on Medscape.com.
In an online statement Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluad Quadrivalent flu vaccines are among those specified in the release.
The organization says that these higher-dose vaccines may be more effective for the aging population, who often have difficulty mounting a strong enough immune response to protect themselves against the flu virus. People older than 65 years struggle the most during flu season and have the highest proportion of hospitalizations and deaths from flu, according to the release.
But the CDC believes that higher-dose vaccines have the potential to better protect against that danger. One study, from The New England Journal of Medicine, reported that high-dose/adjuvanted vaccines prevented flu in older patients 24% better than did lower-dose/nonadjuvanted vaccines.
These types of vaccines work by creating a larger immune response than a standard vaccine dose. In particular, adjuvanted vaccines contain an extra ingredient within them that helps the immune system produce a stronger reaction to the vaccine. These may be things like aluminum salts, which signal the body to respond faster. Higher-dose vaccines similarly promote a stronger immune response by having more particles of the target virus in their mixture. In theory, this means the body will create an enhanced response to the vaccine. For example, a higher-dose vaccine may quadruple the amount of antigens, compared with the standard dose.
The hope is that this recommendation may increase vaccine use across the board, says José Romero, MD, the director of the CDC’s National Center for Immunization and Respiratory Diseases. As quoted in the CDC announcement, Dr. Romero said that this may help reduce racial inequities in access to flu vaccines. A 2019 meta-analysis concluded that Black and Hispanic people are around 30%-40% less likely to get the flu vaccine. So increasing the access to this medication “could help reduce health disparities by making these vaccines more available to racial and ethnic minority groups,” said Dr. Romero.
The decision, spearheaded by CDC Director Rochelle Walensky, MD, follows recommendations from the Advisory Committee on Immunization Practices, which presented on this topic during a June 22 meeting. It is now part of official CDC policy and will continue to be developed as the 2022-2023 flu season approaches.
In addition, the organization says they’ll reveal more details for their plan later this summer, in their Morbidity and Mortality Weekly Report (MMWR). For now, seniors should know that they should try to get the recommended high-dose vaccines, but if they can’t, then a standard dose of whatever their provider has on hand will do.
At this point, there is still no specific vaccine recommendation for people aged under 65 years. The CDC historically avoids specifying one type of vaccine over another and says each should still be effective in younger patients.
A version of this article first appeared on Medscape.com.