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Third-party vendor physicians more likely to prescribe antibiotics during acute care telehealth visits
Third-party vendor physicians appear to be more much more likely than their system-employed counterparts to prescribe antibiotics during acute care telehealth visits for acute respiratory infection (ARI), according to a study in the Journal of Telemedicine and Telecare.
As health systems expand their direct-to-consumer (DTC) virtual care, the quality of that care seems to vary, write the authors. Patients with ARI symptoms make up about one-third of virtual visits. Prescribing practice is a commonly cited measure of care quality for ARI, which is usually viral and rarely benefits from antibiotics.
“When providing care through telehealth, hospital-affiliated emergency physicians practiced better antibiotic stewardship than vendor-supplied, non–hospital-affiliated physicians,” lead study author Kathleen Li, MD, MS, a clinical lecturer in the department of emergency medicine at the University of Michigan, Ann Arbor, told this news organization.
“We had a sense that a difference existed, but the magnitude of the difference was larger than expected,” she said.
Dr. Li and her colleagues retrospectively analyzed on-demand telehealth visits available to health system employees and dependents of a large urban academic health system from March 2018, when the service began, through July 2019.
All 16 affiliated physicians providing ARI care were board-certified in emergency medicine, compared with 2 (8%) of the 25 unaffiliated (vendor-employed) physicians. Most unaffiliated physicians were known to be board-certified in family medicine, internal medicine, or pediatrics.
Unaffiliated physicians were not given access to the health system’s electronic medical record. Instead, all their patient histories, exams, assessments, plans, impressions, and discharge instructions were scanned into the electronic medical record system by other staff the next day.
Unaffiliated doctors were more than twice as likely to prescribe antibiotics
The researchers extracted data on all 257 virtual ARI visits from the electronic health record system, including prescriptions and medication therapeutic class. They performed multivariable logistic regression, adjusting for patient age and time of visit (weekday vs. weekend; day vs. overnight).
Antibiotic prescription rates were similar between weekday and weekend visits, and between day and night visits. Regardless of provider status, older patients were more likely to be prescribed antibiotics (P = .01).
Overall, affiliated physicians prescribed antibiotics during 18% of visits, whereas vendor physicians prescribed antibiotics during 37% of visits. After adjustments, the odds were 2.3 times higher that a patient in a telehealth visit with a vendor provider would be prescribed antibiotics (95% confidence interval, 1.1-4.5).
The predicted antibiotic prescribing rate for ARI was 19% (95% confidence interval, 13%-25%) for affiliated providers vs. 35% (95% CI, 22%-47%) for unaffiliated providers, an average marginal effect of 15% (95% CI, 2%-29%). The difference was even greater (average marginal effect 20%, 95% CI, 4%-35%) when children and patients over 65 were excluded.
Consistent, high-quality care and antibiotic stewardship are needed in all settings
Three experts who were not involved in the study commented on the study.
Joshua W. Elder, MD, MPH, MHS, medical director of Telehealth Express Care (direct-to-consumer telemedicine) at UC Davis Health in Sacramento, Calif., said, “An important unanswered question is how factors such as communication (policy and procedures, practice guidelines), connection (electronic health records), and reimbursement and incentives that health system and vendor-based providers received impacted this outcome.
“As the volume of virtual practices grows, most health systems will need to create a hybrid between health-system-employed and vendor-and/or-payer-supplied physicians,” he added. “Finding ways to create similar quality and outcomes will be essential in the evolving digital health infrastructure being developed.”
Charles Teixeira, DO, an infectious disease specialist at the Medical University of South Carolina in Charleston, said that this study highlighted the need to consistently provide high-quality, evidence-based care regardless of the encounter setting.
“It was important to compare the prescribing practices for commonly used medications, especially those as important as antibiotics,” he added. “Overprescribing antibiotics can have a progressive, long-term effect on a community and increase the risk for patients to develop multidrug-resistant bacteria.”
Jeffrey A. Linder, MD, MPH, the chief of general internal medicine and geriatrics in the department of medicine at Northwestern University in Chicago, commended the authors for investigating the quality of telehealth.
“The major limitation,” he found, “is that the investigators lumped all ARI visits – including those that are potentially antibiotic appropriate (e.g., otitis media, pharyngitis, sinusitis), those that are non–antibiotic appropriate (e.g., bronchitis, influenza, laryngitis, URI, viral syndrome), and those that are nonspecific symptoms (e.g., cough, congestion, fever, sore throat) – into the same category.”
No clinical information was collected or presented that would enable the reader to tell if these two groups of physicians were evaluating different patient populations or even if they just diagnosed patients differently,” he added.
“Our study did not delve into why we saw the difference,” Dr. Li explained. “Exploring potential reasons further will have important implications for how to optimally deliver care via telehealth.”
All authors and independent experts have disclosed no relevant financial relationships. The study received no financial support.
A version of this article first appeared on Medscape.com.
Third-party vendor physicians appear to be more much more likely than their system-employed counterparts to prescribe antibiotics during acute care telehealth visits for acute respiratory infection (ARI), according to a study in the Journal of Telemedicine and Telecare.
As health systems expand their direct-to-consumer (DTC) virtual care, the quality of that care seems to vary, write the authors. Patients with ARI symptoms make up about one-third of virtual visits. Prescribing practice is a commonly cited measure of care quality for ARI, which is usually viral and rarely benefits from antibiotics.
“When providing care through telehealth, hospital-affiliated emergency physicians practiced better antibiotic stewardship than vendor-supplied, non–hospital-affiliated physicians,” lead study author Kathleen Li, MD, MS, a clinical lecturer in the department of emergency medicine at the University of Michigan, Ann Arbor, told this news organization.
“We had a sense that a difference existed, but the magnitude of the difference was larger than expected,” she said.
Dr. Li and her colleagues retrospectively analyzed on-demand telehealth visits available to health system employees and dependents of a large urban academic health system from March 2018, when the service began, through July 2019.
All 16 affiliated physicians providing ARI care were board-certified in emergency medicine, compared with 2 (8%) of the 25 unaffiliated (vendor-employed) physicians. Most unaffiliated physicians were known to be board-certified in family medicine, internal medicine, or pediatrics.
Unaffiliated physicians were not given access to the health system’s electronic medical record. Instead, all their patient histories, exams, assessments, plans, impressions, and discharge instructions were scanned into the electronic medical record system by other staff the next day.
Unaffiliated doctors were more than twice as likely to prescribe antibiotics
The researchers extracted data on all 257 virtual ARI visits from the electronic health record system, including prescriptions and medication therapeutic class. They performed multivariable logistic regression, adjusting for patient age and time of visit (weekday vs. weekend; day vs. overnight).
Antibiotic prescription rates were similar between weekday and weekend visits, and between day and night visits. Regardless of provider status, older patients were more likely to be prescribed antibiotics (P = .01).
Overall, affiliated physicians prescribed antibiotics during 18% of visits, whereas vendor physicians prescribed antibiotics during 37% of visits. After adjustments, the odds were 2.3 times higher that a patient in a telehealth visit with a vendor provider would be prescribed antibiotics (95% confidence interval, 1.1-4.5).
The predicted antibiotic prescribing rate for ARI was 19% (95% confidence interval, 13%-25%) for affiliated providers vs. 35% (95% CI, 22%-47%) for unaffiliated providers, an average marginal effect of 15% (95% CI, 2%-29%). The difference was even greater (average marginal effect 20%, 95% CI, 4%-35%) when children and patients over 65 were excluded.
Consistent, high-quality care and antibiotic stewardship are needed in all settings
Three experts who were not involved in the study commented on the study.
Joshua W. Elder, MD, MPH, MHS, medical director of Telehealth Express Care (direct-to-consumer telemedicine) at UC Davis Health in Sacramento, Calif., said, “An important unanswered question is how factors such as communication (policy and procedures, practice guidelines), connection (electronic health records), and reimbursement and incentives that health system and vendor-based providers received impacted this outcome.
“As the volume of virtual practices grows, most health systems will need to create a hybrid between health-system-employed and vendor-and/or-payer-supplied physicians,” he added. “Finding ways to create similar quality and outcomes will be essential in the evolving digital health infrastructure being developed.”
Charles Teixeira, DO, an infectious disease specialist at the Medical University of South Carolina in Charleston, said that this study highlighted the need to consistently provide high-quality, evidence-based care regardless of the encounter setting.
“It was important to compare the prescribing practices for commonly used medications, especially those as important as antibiotics,” he added. “Overprescribing antibiotics can have a progressive, long-term effect on a community and increase the risk for patients to develop multidrug-resistant bacteria.”
Jeffrey A. Linder, MD, MPH, the chief of general internal medicine and geriatrics in the department of medicine at Northwestern University in Chicago, commended the authors for investigating the quality of telehealth.
“The major limitation,” he found, “is that the investigators lumped all ARI visits – including those that are potentially antibiotic appropriate (e.g., otitis media, pharyngitis, sinusitis), those that are non–antibiotic appropriate (e.g., bronchitis, influenza, laryngitis, URI, viral syndrome), and those that are nonspecific symptoms (e.g., cough, congestion, fever, sore throat) – into the same category.”
No clinical information was collected or presented that would enable the reader to tell if these two groups of physicians were evaluating different patient populations or even if they just diagnosed patients differently,” he added.
“Our study did not delve into why we saw the difference,” Dr. Li explained. “Exploring potential reasons further will have important implications for how to optimally deliver care via telehealth.”
All authors and independent experts have disclosed no relevant financial relationships. The study received no financial support.
A version of this article first appeared on Medscape.com.
Third-party vendor physicians appear to be more much more likely than their system-employed counterparts to prescribe antibiotics during acute care telehealth visits for acute respiratory infection (ARI), according to a study in the Journal of Telemedicine and Telecare.
As health systems expand their direct-to-consumer (DTC) virtual care, the quality of that care seems to vary, write the authors. Patients with ARI symptoms make up about one-third of virtual visits. Prescribing practice is a commonly cited measure of care quality for ARI, which is usually viral and rarely benefits from antibiotics.
“When providing care through telehealth, hospital-affiliated emergency physicians practiced better antibiotic stewardship than vendor-supplied, non–hospital-affiliated physicians,” lead study author Kathleen Li, MD, MS, a clinical lecturer in the department of emergency medicine at the University of Michigan, Ann Arbor, told this news organization.
“We had a sense that a difference existed, but the magnitude of the difference was larger than expected,” she said.
Dr. Li and her colleagues retrospectively analyzed on-demand telehealth visits available to health system employees and dependents of a large urban academic health system from March 2018, when the service began, through July 2019.
All 16 affiliated physicians providing ARI care were board-certified in emergency medicine, compared with 2 (8%) of the 25 unaffiliated (vendor-employed) physicians. Most unaffiliated physicians were known to be board-certified in family medicine, internal medicine, or pediatrics.
Unaffiliated physicians were not given access to the health system’s electronic medical record. Instead, all their patient histories, exams, assessments, plans, impressions, and discharge instructions were scanned into the electronic medical record system by other staff the next day.
Unaffiliated doctors were more than twice as likely to prescribe antibiotics
The researchers extracted data on all 257 virtual ARI visits from the electronic health record system, including prescriptions and medication therapeutic class. They performed multivariable logistic regression, adjusting for patient age and time of visit (weekday vs. weekend; day vs. overnight).
Antibiotic prescription rates were similar between weekday and weekend visits, and between day and night visits. Regardless of provider status, older patients were more likely to be prescribed antibiotics (P = .01).
Overall, affiliated physicians prescribed antibiotics during 18% of visits, whereas vendor physicians prescribed antibiotics during 37% of visits. After adjustments, the odds were 2.3 times higher that a patient in a telehealth visit with a vendor provider would be prescribed antibiotics (95% confidence interval, 1.1-4.5).
The predicted antibiotic prescribing rate for ARI was 19% (95% confidence interval, 13%-25%) for affiliated providers vs. 35% (95% CI, 22%-47%) for unaffiliated providers, an average marginal effect of 15% (95% CI, 2%-29%). The difference was even greater (average marginal effect 20%, 95% CI, 4%-35%) when children and patients over 65 were excluded.
Consistent, high-quality care and antibiotic stewardship are needed in all settings
Three experts who were not involved in the study commented on the study.
Joshua W. Elder, MD, MPH, MHS, medical director of Telehealth Express Care (direct-to-consumer telemedicine) at UC Davis Health in Sacramento, Calif., said, “An important unanswered question is how factors such as communication (policy and procedures, practice guidelines), connection (electronic health records), and reimbursement and incentives that health system and vendor-based providers received impacted this outcome.
“As the volume of virtual practices grows, most health systems will need to create a hybrid between health-system-employed and vendor-and/or-payer-supplied physicians,” he added. “Finding ways to create similar quality and outcomes will be essential in the evolving digital health infrastructure being developed.”
Charles Teixeira, DO, an infectious disease specialist at the Medical University of South Carolina in Charleston, said that this study highlighted the need to consistently provide high-quality, evidence-based care regardless of the encounter setting.
“It was important to compare the prescribing practices for commonly used medications, especially those as important as antibiotics,” he added. “Overprescribing antibiotics can have a progressive, long-term effect on a community and increase the risk for patients to develop multidrug-resistant bacteria.”
Jeffrey A. Linder, MD, MPH, the chief of general internal medicine and geriatrics in the department of medicine at Northwestern University in Chicago, commended the authors for investigating the quality of telehealth.
“The major limitation,” he found, “is that the investigators lumped all ARI visits – including those that are potentially antibiotic appropriate (e.g., otitis media, pharyngitis, sinusitis), those that are non–antibiotic appropriate (e.g., bronchitis, influenza, laryngitis, URI, viral syndrome), and those that are nonspecific symptoms (e.g., cough, congestion, fever, sore throat) – into the same category.”
No clinical information was collected or presented that would enable the reader to tell if these two groups of physicians were evaluating different patient populations or even if they just diagnosed patients differently,” he added.
“Our study did not delve into why we saw the difference,” Dr. Li explained. “Exploring potential reasons further will have important implications for how to optimally deliver care via telehealth.”
All authors and independent experts have disclosed no relevant financial relationships. The study received no financial support.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF TELEMEDICINE AND TELECARE
FDA approves new immunotherapy combo for metastatic melanoma
in adults and children 12 years or older, according to the drug’s manufacturer, Bristol-Myers Squibb.
Approval was based on the company’s RELATIVITY-047 trial, which found a median progression-free survival (PFS) of 10.1 months among 355 patients randomly assigned to the combination therapy compared with 4.6 months among 359 patients who received nivolumab alone (hazard ratio, 0.75; P = .0055).
In the combination therapy group, 18.9% of patients reported a grade 3/4 drug-related adverse event, compared with 9.7% in the nivolumab group; 14.6% of patients in the combination group had drug-related adverse events leading to discontinuation versus 6.7% of those receiving monotherapy, the company noted in a press release.
Relatlimab is the company’s third immune checkpoint inhibitor to reach the U.S. market, joining the PD-1 inhibitor nivolumab and the CTLA-4 blocker ipilimumab. Relatlimab targets LAG-3, a cell-surface receptor found on activated CD4+ T cells.
Nivolumab plus ipilimumab is currently the standard of care for previously untreated metastatic or inoperable melanoma. Both combinations produce similar PFS, but the incidence of grade 3/4 adverse events is higher with ipilimumab, according to a Jan. 6, 2022, editorial in the New England Journal of Medicine.
Musculoskeletal pain, fatigue, rash, pruritus, and diarrhea were the most common adverse reactions with combination nivolumab/relatlimab, occurring in 20% or more of RELATIVITY-047 trial participants.
Adrenal insufficiency, anemia, colitis, pneumonia, and myocardial infarction were the most frequent serious adverse reactions, but each occurred in less than 2% of patients. There were three fatal adverse events in the trial caused by hemophagocytic lymphohistiocytosis, acute lung edema, and pneumonitis.
The approved dosage is 480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks.
A version of this article first appeared on Medscape.com.
in adults and children 12 years or older, according to the drug’s manufacturer, Bristol-Myers Squibb.
Approval was based on the company’s RELATIVITY-047 trial, which found a median progression-free survival (PFS) of 10.1 months among 355 patients randomly assigned to the combination therapy compared with 4.6 months among 359 patients who received nivolumab alone (hazard ratio, 0.75; P = .0055).
In the combination therapy group, 18.9% of patients reported a grade 3/4 drug-related adverse event, compared with 9.7% in the nivolumab group; 14.6% of patients in the combination group had drug-related adverse events leading to discontinuation versus 6.7% of those receiving monotherapy, the company noted in a press release.
Relatlimab is the company’s third immune checkpoint inhibitor to reach the U.S. market, joining the PD-1 inhibitor nivolumab and the CTLA-4 blocker ipilimumab. Relatlimab targets LAG-3, a cell-surface receptor found on activated CD4+ T cells.
Nivolumab plus ipilimumab is currently the standard of care for previously untreated metastatic or inoperable melanoma. Both combinations produce similar PFS, but the incidence of grade 3/4 adverse events is higher with ipilimumab, according to a Jan. 6, 2022, editorial in the New England Journal of Medicine.
Musculoskeletal pain, fatigue, rash, pruritus, and diarrhea were the most common adverse reactions with combination nivolumab/relatlimab, occurring in 20% or more of RELATIVITY-047 trial participants.
Adrenal insufficiency, anemia, colitis, pneumonia, and myocardial infarction were the most frequent serious adverse reactions, but each occurred in less than 2% of patients. There were three fatal adverse events in the trial caused by hemophagocytic lymphohistiocytosis, acute lung edema, and pneumonitis.
The approved dosage is 480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks.
A version of this article first appeared on Medscape.com.
in adults and children 12 years or older, according to the drug’s manufacturer, Bristol-Myers Squibb.
Approval was based on the company’s RELATIVITY-047 trial, which found a median progression-free survival (PFS) of 10.1 months among 355 patients randomly assigned to the combination therapy compared with 4.6 months among 359 patients who received nivolumab alone (hazard ratio, 0.75; P = .0055).
In the combination therapy group, 18.9% of patients reported a grade 3/4 drug-related adverse event, compared with 9.7% in the nivolumab group; 14.6% of patients in the combination group had drug-related adverse events leading to discontinuation versus 6.7% of those receiving monotherapy, the company noted in a press release.
Relatlimab is the company’s third immune checkpoint inhibitor to reach the U.S. market, joining the PD-1 inhibitor nivolumab and the CTLA-4 blocker ipilimumab. Relatlimab targets LAG-3, a cell-surface receptor found on activated CD4+ T cells.
Nivolumab plus ipilimumab is currently the standard of care for previously untreated metastatic or inoperable melanoma. Both combinations produce similar PFS, but the incidence of grade 3/4 adverse events is higher with ipilimumab, according to a Jan. 6, 2022, editorial in the New England Journal of Medicine.
Musculoskeletal pain, fatigue, rash, pruritus, and diarrhea were the most common adverse reactions with combination nivolumab/relatlimab, occurring in 20% or more of RELATIVITY-047 trial participants.
Adrenal insufficiency, anemia, colitis, pneumonia, and myocardial infarction were the most frequent serious adverse reactions, but each occurred in less than 2% of patients. There were three fatal adverse events in the trial caused by hemophagocytic lymphohistiocytosis, acute lung edema, and pneumonitis.
The approved dosage is 480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks.
A version of this article first appeared on Medscape.com.
WHO issues new TB guidelines for children and adolescents
The World Health Organization now recommends shortened treatment for children with mild tuberculosis, as well as two oral TB treatments (bedaquiline and delamanid) for use in children of all ages. The updated guidelines for TB management in children and adolescents were announced March 21 ahead of World Tuberculosis Day on March 24.
The agency also called for increased investment in global TB programs, noting that in 2020, TB deaths increased for the first time in over a decade. “We cannot falter in our commitment to reach and save every man, woman, child, family, and community impacted by this deadly disease,” said Tereza Kasaeva, MD, PhD, director of the WHO Global Tuberculosis Programme during a press conference.
TB is the 13th-leading cause of death and the second top infectious killer after COVID-19, with more than 4,100 people dying from TB every day. WHO estimates that 1.1 million children fall ill with TB each year.
Calls for investment
The increase in TB deaths from 1.4 million in 2019 to 1.5 million in 2020 was coupled with a decrease in funding. From 2019-2020, global spending for TB diagnostic, treatment, and prevention services fell from $5.8 billion to $5.3 billion. This is less than half of the $13 billion target funding amount for 2022, Dr. Kasaeva said.
Efforts to expand access to TB care have fallen short mainly because of this lack of funding, especially for children. In 2020, about 63% of children under 15 years of age with TB either did not receive or were not reported to have access to TB diagnosis and treatment services, which rose to 72% in children under age 5. Almost two-thirds of children under age 5 also did not receive TB preventive treatment in 2022, according to WHO statistics.
The socioeconomic ramifications of the COVID-19 pandemic as well as ongoing conflict in Eastern Europe, Africa, and the Middle East have “further exacerbated the situation,” Dr. Kasaeva said. “This conveys the urgent need to dramatically increase investments to ramp up the fight against TB and achieve commitments to end TB made by global leaders.”
Dr. Kasaeva laid out WHO’s main points for global investment in TB care:
- Increase domestic and international funding to close gaps in TB research and program implementation. For countries with smaller economies, increased international investment will be necessary in the short or medium term to help regain progress.
- Double funding for TB research, including vaccines.
- Invest in sustaining TB programs and services during the COVID-19 pandemic and ongoing crises so care is not disrupted.
New guidelines
Dr. Kasaeva also noted that adoption of WHO’s new guidelines for children and adolescents should be fast-tracked to improve access to and quality of care. The updates include:
- Rapid molecular tests called Xpert Ultra should be used as the initial test for TB in children and adolescents.
- Diagnostic testing can now include noninvasive specimens, like stool samples.
- Children with mild TB can be treated with a , rather than 6 months. This shortened regimen will allow children to return to school faster and save money for families and the health care system, said Kerri Viney, MD, PhD, a team lead for the WHO Tuberculosis Programme, with a focus on vulnerable populations, including children. She presented the new guidelines during the WHO press conference.
- The recommended treatment regimen for TB meningitis has also been shortened from 12 to 6 months.
Two oral medications for drug-resistant TB (bedaquiline and delamanid) are now recommended for use in children of all ages. “There is no longer a need for painful injections that can have serious side effects, including deafness,” Dr. Viney said.
Health systems should develop new models of decentralized and integrated TB care to bring TB care closer to where children live.
The guidelines are available on the WHO website.
“The WHO guidelines issued today are a game changer for children and adolescents with TB,” Dr. Kasaeva said. The next step is assisting countries in implementing these updates so that children and adolescents globally have access to high quality TB care,” Dr. Viney added. “We have the policy recommendations. We have the implementation guidance, we have child-friendly formulations of TB medicines,” she said. “Let us not wait any longer. Let us invest to end TB in children and adolescents.”
A version of this article first appeared on Medscape.com.
The World Health Organization now recommends shortened treatment for children with mild tuberculosis, as well as two oral TB treatments (bedaquiline and delamanid) for use in children of all ages. The updated guidelines for TB management in children and adolescents were announced March 21 ahead of World Tuberculosis Day on March 24.
The agency also called for increased investment in global TB programs, noting that in 2020, TB deaths increased for the first time in over a decade. “We cannot falter in our commitment to reach and save every man, woman, child, family, and community impacted by this deadly disease,” said Tereza Kasaeva, MD, PhD, director of the WHO Global Tuberculosis Programme during a press conference.
TB is the 13th-leading cause of death and the second top infectious killer after COVID-19, with more than 4,100 people dying from TB every day. WHO estimates that 1.1 million children fall ill with TB each year.
Calls for investment
The increase in TB deaths from 1.4 million in 2019 to 1.5 million in 2020 was coupled with a decrease in funding. From 2019-2020, global spending for TB diagnostic, treatment, and prevention services fell from $5.8 billion to $5.3 billion. This is less than half of the $13 billion target funding amount for 2022, Dr. Kasaeva said.
Efforts to expand access to TB care have fallen short mainly because of this lack of funding, especially for children. In 2020, about 63% of children under 15 years of age with TB either did not receive or were not reported to have access to TB diagnosis and treatment services, which rose to 72% in children under age 5. Almost two-thirds of children under age 5 also did not receive TB preventive treatment in 2022, according to WHO statistics.
The socioeconomic ramifications of the COVID-19 pandemic as well as ongoing conflict in Eastern Europe, Africa, and the Middle East have “further exacerbated the situation,” Dr. Kasaeva said. “This conveys the urgent need to dramatically increase investments to ramp up the fight against TB and achieve commitments to end TB made by global leaders.”
Dr. Kasaeva laid out WHO’s main points for global investment in TB care:
- Increase domestic and international funding to close gaps in TB research and program implementation. For countries with smaller economies, increased international investment will be necessary in the short or medium term to help regain progress.
- Double funding for TB research, including vaccines.
- Invest in sustaining TB programs and services during the COVID-19 pandemic and ongoing crises so care is not disrupted.
New guidelines
Dr. Kasaeva also noted that adoption of WHO’s new guidelines for children and adolescents should be fast-tracked to improve access to and quality of care. The updates include:
- Rapid molecular tests called Xpert Ultra should be used as the initial test for TB in children and adolescents.
- Diagnostic testing can now include noninvasive specimens, like stool samples.
- Children with mild TB can be treated with a , rather than 6 months. This shortened regimen will allow children to return to school faster and save money for families and the health care system, said Kerri Viney, MD, PhD, a team lead for the WHO Tuberculosis Programme, with a focus on vulnerable populations, including children. She presented the new guidelines during the WHO press conference.
- The recommended treatment regimen for TB meningitis has also been shortened from 12 to 6 months.
Two oral medications for drug-resistant TB (bedaquiline and delamanid) are now recommended for use in children of all ages. “There is no longer a need for painful injections that can have serious side effects, including deafness,” Dr. Viney said.
Health systems should develop new models of decentralized and integrated TB care to bring TB care closer to where children live.
The guidelines are available on the WHO website.
“The WHO guidelines issued today are a game changer for children and adolescents with TB,” Dr. Kasaeva said. The next step is assisting countries in implementing these updates so that children and adolescents globally have access to high quality TB care,” Dr. Viney added. “We have the policy recommendations. We have the implementation guidance, we have child-friendly formulations of TB medicines,” she said. “Let us not wait any longer. Let us invest to end TB in children and adolescents.”
A version of this article first appeared on Medscape.com.
The World Health Organization now recommends shortened treatment for children with mild tuberculosis, as well as two oral TB treatments (bedaquiline and delamanid) for use in children of all ages. The updated guidelines for TB management in children and adolescents were announced March 21 ahead of World Tuberculosis Day on March 24.
The agency also called for increased investment in global TB programs, noting that in 2020, TB deaths increased for the first time in over a decade. “We cannot falter in our commitment to reach and save every man, woman, child, family, and community impacted by this deadly disease,” said Tereza Kasaeva, MD, PhD, director of the WHO Global Tuberculosis Programme during a press conference.
TB is the 13th-leading cause of death and the second top infectious killer after COVID-19, with more than 4,100 people dying from TB every day. WHO estimates that 1.1 million children fall ill with TB each year.
Calls for investment
The increase in TB deaths from 1.4 million in 2019 to 1.5 million in 2020 was coupled with a decrease in funding. From 2019-2020, global spending for TB diagnostic, treatment, and prevention services fell from $5.8 billion to $5.3 billion. This is less than half of the $13 billion target funding amount for 2022, Dr. Kasaeva said.
Efforts to expand access to TB care have fallen short mainly because of this lack of funding, especially for children. In 2020, about 63% of children under 15 years of age with TB either did not receive or were not reported to have access to TB diagnosis and treatment services, which rose to 72% in children under age 5. Almost two-thirds of children under age 5 also did not receive TB preventive treatment in 2022, according to WHO statistics.
The socioeconomic ramifications of the COVID-19 pandemic as well as ongoing conflict in Eastern Europe, Africa, and the Middle East have “further exacerbated the situation,” Dr. Kasaeva said. “This conveys the urgent need to dramatically increase investments to ramp up the fight against TB and achieve commitments to end TB made by global leaders.”
Dr. Kasaeva laid out WHO’s main points for global investment in TB care:
- Increase domestic and international funding to close gaps in TB research and program implementation. For countries with smaller economies, increased international investment will be necessary in the short or medium term to help regain progress.
- Double funding for TB research, including vaccines.
- Invest in sustaining TB programs and services during the COVID-19 pandemic and ongoing crises so care is not disrupted.
New guidelines
Dr. Kasaeva also noted that adoption of WHO’s new guidelines for children and adolescents should be fast-tracked to improve access to and quality of care. The updates include:
- Rapid molecular tests called Xpert Ultra should be used as the initial test for TB in children and adolescents.
- Diagnostic testing can now include noninvasive specimens, like stool samples.
- Children with mild TB can be treated with a , rather than 6 months. This shortened regimen will allow children to return to school faster and save money for families and the health care system, said Kerri Viney, MD, PhD, a team lead for the WHO Tuberculosis Programme, with a focus on vulnerable populations, including children. She presented the new guidelines during the WHO press conference.
- The recommended treatment regimen for TB meningitis has also been shortened from 12 to 6 months.
Two oral medications for drug-resistant TB (bedaquiline and delamanid) are now recommended for use in children of all ages. “There is no longer a need for painful injections that can have serious side effects, including deafness,” Dr. Viney said.
Health systems should develop new models of decentralized and integrated TB care to bring TB care closer to where children live.
The guidelines are available on the WHO website.
“The WHO guidelines issued today are a game changer for children and adolescents with TB,” Dr. Kasaeva said. The next step is assisting countries in implementing these updates so that children and adolescents globally have access to high quality TB care,” Dr. Viney added. “We have the policy recommendations. We have the implementation guidance, we have child-friendly formulations of TB medicines,” she said. “Let us not wait any longer. Let us invest to end TB in children and adolescents.”
A version of this article first appeared on Medscape.com.
COVID-19 doesn’t spike A1c levels
Key takeaways
Results from a retrospective, observational, case-control study of more than 20,000 people from a single U.S. medical center showed a statistically significant but clinically insignificant increase in A1c in people following COVID-19 infection, in both those with and without diabetes.
After people received a diagnosis of COVID-19 infection, they were 40% more likely to also receive a diagnosis of type 2 diabetes, compared with people who tested negative for COVID-19, a difference that was significant and could be explained by the increased medical care received by people who test positive for COVID-19.
The risk of incident diabetic ketoacidosis (DKA) among people who tested positive for COVID-19 was significantly higher among those with pre-existing type 2 diabetes, those using insulin, and among Black individuals.
Why this matters
The authors said that their study is the first report of evidence that infection with COVID-19 affects A1c levels in a large, real-world clinical cohort.
Until now, the impact of COVID-19 infection on A1c remained unclear. Results from previous studies indicated that COVID-19 infection may increase A1c levels, but the studied cohorts were small and lacked uninfected controls.
The current study included 8,755 people infected with COVID-19, had data from both before and after the infection on diabetes status and A1c levels, and also included many matched, uninfected people who served as controls.
Study design
Data came from a Cleveland Clinic registry that included 81,093 people who tested positive for COVID-19 between March 2020 and May 2021 and 153,034 matched individuals who tested negative for COVID-19 during the same period.
The researchers retrospectively selected patients with an A1c recorded within 12 months before their COVID-19 test, as well as a second A1c value recorded within 12 months after COVID-19 testing. This produced a study cohort of 8,755 COVID-positive people and 11,998 matched people who tested negative for COVID-19.
To evaluate the risk of DKA onset after COVID-19 infection, the authors identified two sub-cohorts that excluded those with a history of DKA. The sub-cohorts were 701 people with type 1 diabetes and 21,830 with type 2 diabetes.
Key results
The investigators found a statistically significant but clinically insignificant A1c increase following a positive COVID-19 test, an average A1c increase of 0.06 percentage points. Those who tested negative for COVID-19 had a clinically insignificant change in their average A1c level that was of borderline statistical significance, an average increase of 0.02 percentage points (P = .05).
The statistically significant but clinically insignificant increase in A1c following infection with COVID-19 was similar in people with and without type 2 diabetes prior to infection.
In patients with type 2 diabetes who became infected with COVID-19, the researchers saw significant positive associations between higher A1c levels before infection and time to hospitalization (hazard ratio, 1.07), need for assisted breathing (HR, 1.06), and ICU admission (HR, 1.07).
Following a COVID-19 infection, people were 40% more likely to receive a diagnosis of incident type 2 diabetes, compared with matched uninfected people. The authors said a possible explanation is that after diagnosis of COVID-19, infected people in general received more intensified care that led to better identification of those with underlying type 2 diabetes.
The 701 people included with pre-existing type 1 diabetes showed no significant difference in their rate of developing DKA between those infected and not infected with COVID-19.
Among the 21,830 people with pre-existing type 2 diabetes, the DKA risk was a significant 35% greater for those who were infected with COVID-19, compared with those who were uninfected. The magnitude of this increased relative risk was even higher among the patients with type 2 diabetes who used insulin as part of their treatment.
The difference in DKA risk didn’t differ between Black and White patients who were not infected with COVID-19, but among those infected by COVID-19, Black patients were more than twice as likely to be diagnosed with DKA, compared with White patients, a significant difference.
Black patients with type 2 diabetes who became infected with COVID-19 had a significant (63%) increased rate of DKA compared with Black patients with type 2 diabetes who remained uninfected.
Limitations
The study included patients with A1c measurements made up to 12 months prior to their COVID-19 test, and hence comorbid conditions, medication changes during this period, or other factors may have affected subsequent A1c levels. To address this, the authors also assessed outcomes at 3- and 6-month intervals, which produced results consistent with the 12-month findings.
The researchers did not have A1c values for many of the more than 234,000 people in the entire registry who underwent COVID-19 testing from March 2020-May 2021 at the Cleveland Clinic, omissions that may have biased the study cohort.
This was a single-center study. Some patients may have received care outside of the center, hence records of those episodes could not be included.
Disclosures
The study received no commercial funding. Four authors received consulting and speaker honoraria and research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Corcept Therapeutics, Diasome, Eli Lilly, Merck, Novo Nordisk, and Sanofi. Three authors have intellectual property related to treatment decisionmaking in the context of type 2 diabetes.
This is a summary of a preprint research study “Impacts of COVID-19 on glycemia and risk of diabetic ketoacidosis,” written by researchers at the Cleveland Clinic on medRxiv. The study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org.
A version of this article first appeared on Medscape.com.
Key takeaways
Results from a retrospective, observational, case-control study of more than 20,000 people from a single U.S. medical center showed a statistically significant but clinically insignificant increase in A1c in people following COVID-19 infection, in both those with and without diabetes.
After people received a diagnosis of COVID-19 infection, they were 40% more likely to also receive a diagnosis of type 2 diabetes, compared with people who tested negative for COVID-19, a difference that was significant and could be explained by the increased medical care received by people who test positive for COVID-19.
The risk of incident diabetic ketoacidosis (DKA) among people who tested positive for COVID-19 was significantly higher among those with pre-existing type 2 diabetes, those using insulin, and among Black individuals.
Why this matters
The authors said that their study is the first report of evidence that infection with COVID-19 affects A1c levels in a large, real-world clinical cohort.
Until now, the impact of COVID-19 infection on A1c remained unclear. Results from previous studies indicated that COVID-19 infection may increase A1c levels, but the studied cohorts were small and lacked uninfected controls.
The current study included 8,755 people infected with COVID-19, had data from both before and after the infection on diabetes status and A1c levels, and also included many matched, uninfected people who served as controls.
Study design
Data came from a Cleveland Clinic registry that included 81,093 people who tested positive for COVID-19 between March 2020 and May 2021 and 153,034 matched individuals who tested negative for COVID-19 during the same period.
The researchers retrospectively selected patients with an A1c recorded within 12 months before their COVID-19 test, as well as a second A1c value recorded within 12 months after COVID-19 testing. This produced a study cohort of 8,755 COVID-positive people and 11,998 matched people who tested negative for COVID-19.
To evaluate the risk of DKA onset after COVID-19 infection, the authors identified two sub-cohorts that excluded those with a history of DKA. The sub-cohorts were 701 people with type 1 diabetes and 21,830 with type 2 diabetes.
Key results
The investigators found a statistically significant but clinically insignificant A1c increase following a positive COVID-19 test, an average A1c increase of 0.06 percentage points. Those who tested negative for COVID-19 had a clinically insignificant change in their average A1c level that was of borderline statistical significance, an average increase of 0.02 percentage points (P = .05).
The statistically significant but clinically insignificant increase in A1c following infection with COVID-19 was similar in people with and without type 2 diabetes prior to infection.
In patients with type 2 diabetes who became infected with COVID-19, the researchers saw significant positive associations between higher A1c levels before infection and time to hospitalization (hazard ratio, 1.07), need for assisted breathing (HR, 1.06), and ICU admission (HR, 1.07).
Following a COVID-19 infection, people were 40% more likely to receive a diagnosis of incident type 2 diabetes, compared with matched uninfected people. The authors said a possible explanation is that after diagnosis of COVID-19, infected people in general received more intensified care that led to better identification of those with underlying type 2 diabetes.
The 701 people included with pre-existing type 1 diabetes showed no significant difference in their rate of developing DKA between those infected and not infected with COVID-19.
Among the 21,830 people with pre-existing type 2 diabetes, the DKA risk was a significant 35% greater for those who were infected with COVID-19, compared with those who were uninfected. The magnitude of this increased relative risk was even higher among the patients with type 2 diabetes who used insulin as part of their treatment.
The difference in DKA risk didn’t differ between Black and White patients who were not infected with COVID-19, but among those infected by COVID-19, Black patients were more than twice as likely to be diagnosed with DKA, compared with White patients, a significant difference.
Black patients with type 2 diabetes who became infected with COVID-19 had a significant (63%) increased rate of DKA compared with Black patients with type 2 diabetes who remained uninfected.
Limitations
The study included patients with A1c measurements made up to 12 months prior to their COVID-19 test, and hence comorbid conditions, medication changes during this period, or other factors may have affected subsequent A1c levels. To address this, the authors also assessed outcomes at 3- and 6-month intervals, which produced results consistent with the 12-month findings.
The researchers did not have A1c values for many of the more than 234,000 people in the entire registry who underwent COVID-19 testing from March 2020-May 2021 at the Cleveland Clinic, omissions that may have biased the study cohort.
This was a single-center study. Some patients may have received care outside of the center, hence records of those episodes could not be included.
Disclosures
The study received no commercial funding. Four authors received consulting and speaker honoraria and research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Corcept Therapeutics, Diasome, Eli Lilly, Merck, Novo Nordisk, and Sanofi. Three authors have intellectual property related to treatment decisionmaking in the context of type 2 diabetes.
This is a summary of a preprint research study “Impacts of COVID-19 on glycemia and risk of diabetic ketoacidosis,” written by researchers at the Cleveland Clinic on medRxiv. The study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org.
A version of this article first appeared on Medscape.com.
Key takeaways
Results from a retrospective, observational, case-control study of more than 20,000 people from a single U.S. medical center showed a statistically significant but clinically insignificant increase in A1c in people following COVID-19 infection, in both those with and without diabetes.
After people received a diagnosis of COVID-19 infection, they were 40% more likely to also receive a diagnosis of type 2 diabetes, compared with people who tested negative for COVID-19, a difference that was significant and could be explained by the increased medical care received by people who test positive for COVID-19.
The risk of incident diabetic ketoacidosis (DKA) among people who tested positive for COVID-19 was significantly higher among those with pre-existing type 2 diabetes, those using insulin, and among Black individuals.
Why this matters
The authors said that their study is the first report of evidence that infection with COVID-19 affects A1c levels in a large, real-world clinical cohort.
Until now, the impact of COVID-19 infection on A1c remained unclear. Results from previous studies indicated that COVID-19 infection may increase A1c levels, but the studied cohorts were small and lacked uninfected controls.
The current study included 8,755 people infected with COVID-19, had data from both before and after the infection on diabetes status and A1c levels, and also included many matched, uninfected people who served as controls.
Study design
Data came from a Cleveland Clinic registry that included 81,093 people who tested positive for COVID-19 between March 2020 and May 2021 and 153,034 matched individuals who tested negative for COVID-19 during the same period.
The researchers retrospectively selected patients with an A1c recorded within 12 months before their COVID-19 test, as well as a second A1c value recorded within 12 months after COVID-19 testing. This produced a study cohort of 8,755 COVID-positive people and 11,998 matched people who tested negative for COVID-19.
To evaluate the risk of DKA onset after COVID-19 infection, the authors identified two sub-cohorts that excluded those with a history of DKA. The sub-cohorts were 701 people with type 1 diabetes and 21,830 with type 2 diabetes.
Key results
The investigators found a statistically significant but clinically insignificant A1c increase following a positive COVID-19 test, an average A1c increase of 0.06 percentage points. Those who tested negative for COVID-19 had a clinically insignificant change in their average A1c level that was of borderline statistical significance, an average increase of 0.02 percentage points (P = .05).
The statistically significant but clinically insignificant increase in A1c following infection with COVID-19 was similar in people with and without type 2 diabetes prior to infection.
In patients with type 2 diabetes who became infected with COVID-19, the researchers saw significant positive associations between higher A1c levels before infection and time to hospitalization (hazard ratio, 1.07), need for assisted breathing (HR, 1.06), and ICU admission (HR, 1.07).
Following a COVID-19 infection, people were 40% more likely to receive a diagnosis of incident type 2 diabetes, compared with matched uninfected people. The authors said a possible explanation is that after diagnosis of COVID-19, infected people in general received more intensified care that led to better identification of those with underlying type 2 diabetes.
The 701 people included with pre-existing type 1 diabetes showed no significant difference in their rate of developing DKA between those infected and not infected with COVID-19.
Among the 21,830 people with pre-existing type 2 diabetes, the DKA risk was a significant 35% greater for those who were infected with COVID-19, compared with those who were uninfected. The magnitude of this increased relative risk was even higher among the patients with type 2 diabetes who used insulin as part of their treatment.
The difference in DKA risk didn’t differ between Black and White patients who were not infected with COVID-19, but among those infected by COVID-19, Black patients were more than twice as likely to be diagnosed with DKA, compared with White patients, a significant difference.
Black patients with type 2 diabetes who became infected with COVID-19 had a significant (63%) increased rate of DKA compared with Black patients with type 2 diabetes who remained uninfected.
Limitations
The study included patients with A1c measurements made up to 12 months prior to their COVID-19 test, and hence comorbid conditions, medication changes during this period, or other factors may have affected subsequent A1c levels. To address this, the authors also assessed outcomes at 3- and 6-month intervals, which produced results consistent with the 12-month findings.
The researchers did not have A1c values for many of the more than 234,000 people in the entire registry who underwent COVID-19 testing from March 2020-May 2021 at the Cleveland Clinic, omissions that may have biased the study cohort.
This was a single-center study. Some patients may have received care outside of the center, hence records of those episodes could not be included.
Disclosures
The study received no commercial funding. Four authors received consulting and speaker honoraria and research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Corcept Therapeutics, Diasome, Eli Lilly, Merck, Novo Nordisk, and Sanofi. Three authors have intellectual property related to treatment decisionmaking in the context of type 2 diabetes.
This is a summary of a preprint research study “Impacts of COVID-19 on glycemia and risk of diabetic ketoacidosis,” written by researchers at the Cleveland Clinic on medRxiv. The study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org.
A version of this article first appeared on Medscape.com.
Hands trained for surgery now on machine gun: Kyiv oncologist
The pediatric oncology unit in Kyiv’s National Cancer Institute is empty, with all the children evacuated to safer hospitals in Western Ukraine or further, making it a good place to talk on Zoom.
Against a backdrop of colorful animals painted on the wall, Oleksandr Stakhovskyi, MD, PhD, speaks optimistically about the future of his city, his country, and even his patients, despite acknowledging that his surgical hands are now trained to use a machine gun.
“It’s not as bad as last week,” he laughs, explaining that residents of Kyiv are more relaxed now, despite the air raid sirens, because the city’s anti-missile system has thus far kept them safe.
Even still, missiles have continued hitting civilian residences and Dr. Stakhovskyi, a urologic-oncology surgeon, has evacuated his wife and children out of the country, as have 70% of his colleagues. But for those who stayed in Kyiv, there is a strong resolve.
“People working in IT, in law, in other professions — they just took the guns and stayed in Kyiv,” he said in an interview. “They are just civilians, armed, trying to protect and fortify Kyiv — to make it unbreakable.”
Dr. Stakhovskyi doesn’t have a background in the military, but he now knows how to use a machine gun. “I am a super-specialized oncologist, [but] I realize if I leave right now it will give the Russians momentum to come in. The longer it takes, the weaker the opponent army will become, and we are more and more optimistic,” he said.
In Kyiv, Dr. Stakhovskyi is working half the time at the cancer hospital and the other half at the nearby military hospital, but he said so far war casualties are minimal within the city, and even the flow of patients with cancer has reduced.
“I had my surgeries planned up until the end of March, but when the war started, they were all postponed,” he said. Emergency cancer surgeries have continued, and now there is talk of resuming some others. “We will stratify patients into categories based on need,” he said. “For those patients whose surgery can basically stop the disease and they don’t need neoadjuvant chemo, we’ll probably be doing those.”
Medical oncology clinics have also resumed, said Dr. Stakhovskyi, but the volume of patients is low, because many have left the city. An estimated 3.3 million people have left Ukraine since the Russian invasion on February 24.
Across the country, in Lviv near the Polish border, another surgical oncologist tells a different story. Andriy Hrynkiv, MD, from Lviv Regional Cancer Center, says his hospital has seen a dramatic increase in patients, displaced internally from areas where the medical infrastructure has collapsed.
“Russian forces have destroyed more than 117 hospitals, 43 ambulances have been shot at, 6 doctors have been killed, and 13 wounded,” Dr. Hrynkiv said. In the city of Mariupol, “doctors and patients have been taken hostage,” he said, used by Russian forces as a human shield. In Kharkiv, with approximately 1.5 million residents, the only oncologic hospital has been destroyed.
There is a shortage and instability of medical supplies including all iodine-containing medications that citizens are stocking up on in the face of a potential nuclear attack, he said.
Dr. Hrynkiv was speaking on a webcast organized by the American Society of Clinical Oncology (ASCO) and European Cancer Organisation (ECO).
The two organizations are collaborating with each other and the World Health Organization to create a special network that is aiming to connect professionals, academic and clinical centers, and patient groups.
Additionally, the Ukranian Society of Clinical Oncology (USCO), cofounded by Dr. Stakhovskyi, is trying to keep patients connected with nongovernment organizations.
“These patient organizations moved west when the war started, but they still use us to help them make contact with foreign doctors,” he said. “We have tried to centralize this process but it’s very difficult because patients and organizations are also calling doctors and centers directly looking for treatment options.”
He says USCO is also coordinating the distribution of a donation of immunotherapy pembrolizumab (Keytruda) from pharmaceutical company Merck Sharp & Dohme. “It’s a huge influx of this drug,” he says. “They’ve promised something like 2,000 doses to cover 230 patients for 3 months at least. Usually this is not an easy drug to access for people in Ukraine because it’s really expensive.”
Dr. Stakhovskyi said the optimism he feels is fueled by the support that Ukrainians feel from the rest of the world.
“We see the reaction of our international colleagues. It is so impressive and touching — lots of my ex-professors are texting me and sending me messages from all over the place, from Germany, from Canada, from France, from the United States,” he said. “And if we can be optimistic for ourselves, definitely that translates to our patients.”
A version of this article first appeared on Medscape.com.
The pediatric oncology unit in Kyiv’s National Cancer Institute is empty, with all the children evacuated to safer hospitals in Western Ukraine or further, making it a good place to talk on Zoom.
Against a backdrop of colorful animals painted on the wall, Oleksandr Stakhovskyi, MD, PhD, speaks optimistically about the future of his city, his country, and even his patients, despite acknowledging that his surgical hands are now trained to use a machine gun.
“It’s not as bad as last week,” he laughs, explaining that residents of Kyiv are more relaxed now, despite the air raid sirens, because the city’s anti-missile system has thus far kept them safe.
Even still, missiles have continued hitting civilian residences and Dr. Stakhovskyi, a urologic-oncology surgeon, has evacuated his wife and children out of the country, as have 70% of his colleagues. But for those who stayed in Kyiv, there is a strong resolve.
“People working in IT, in law, in other professions — they just took the guns and stayed in Kyiv,” he said in an interview. “They are just civilians, armed, trying to protect and fortify Kyiv — to make it unbreakable.”
Dr. Stakhovskyi doesn’t have a background in the military, but he now knows how to use a machine gun. “I am a super-specialized oncologist, [but] I realize if I leave right now it will give the Russians momentum to come in. The longer it takes, the weaker the opponent army will become, and we are more and more optimistic,” he said.
In Kyiv, Dr. Stakhovskyi is working half the time at the cancer hospital and the other half at the nearby military hospital, but he said so far war casualties are minimal within the city, and even the flow of patients with cancer has reduced.
“I had my surgeries planned up until the end of March, but when the war started, they were all postponed,” he said. Emergency cancer surgeries have continued, and now there is talk of resuming some others. “We will stratify patients into categories based on need,” he said. “For those patients whose surgery can basically stop the disease and they don’t need neoadjuvant chemo, we’ll probably be doing those.”
Medical oncology clinics have also resumed, said Dr. Stakhovskyi, but the volume of patients is low, because many have left the city. An estimated 3.3 million people have left Ukraine since the Russian invasion on February 24.
Across the country, in Lviv near the Polish border, another surgical oncologist tells a different story. Andriy Hrynkiv, MD, from Lviv Regional Cancer Center, says his hospital has seen a dramatic increase in patients, displaced internally from areas where the medical infrastructure has collapsed.
“Russian forces have destroyed more than 117 hospitals, 43 ambulances have been shot at, 6 doctors have been killed, and 13 wounded,” Dr. Hrynkiv said. In the city of Mariupol, “doctors and patients have been taken hostage,” he said, used by Russian forces as a human shield. In Kharkiv, with approximately 1.5 million residents, the only oncologic hospital has been destroyed.
There is a shortage and instability of medical supplies including all iodine-containing medications that citizens are stocking up on in the face of a potential nuclear attack, he said.
Dr. Hrynkiv was speaking on a webcast organized by the American Society of Clinical Oncology (ASCO) and European Cancer Organisation (ECO).
The two organizations are collaborating with each other and the World Health Organization to create a special network that is aiming to connect professionals, academic and clinical centers, and patient groups.
Additionally, the Ukranian Society of Clinical Oncology (USCO), cofounded by Dr. Stakhovskyi, is trying to keep patients connected with nongovernment organizations.
“These patient organizations moved west when the war started, but they still use us to help them make contact with foreign doctors,” he said. “We have tried to centralize this process but it’s very difficult because patients and organizations are also calling doctors and centers directly looking for treatment options.”
He says USCO is also coordinating the distribution of a donation of immunotherapy pembrolizumab (Keytruda) from pharmaceutical company Merck Sharp & Dohme. “It’s a huge influx of this drug,” he says. “They’ve promised something like 2,000 doses to cover 230 patients for 3 months at least. Usually this is not an easy drug to access for people in Ukraine because it’s really expensive.”
Dr. Stakhovskyi said the optimism he feels is fueled by the support that Ukrainians feel from the rest of the world.
“We see the reaction of our international colleagues. It is so impressive and touching — lots of my ex-professors are texting me and sending me messages from all over the place, from Germany, from Canada, from France, from the United States,” he said. “And if we can be optimistic for ourselves, definitely that translates to our patients.”
A version of this article first appeared on Medscape.com.
The pediatric oncology unit in Kyiv’s National Cancer Institute is empty, with all the children evacuated to safer hospitals in Western Ukraine or further, making it a good place to talk on Zoom.
Against a backdrop of colorful animals painted on the wall, Oleksandr Stakhovskyi, MD, PhD, speaks optimistically about the future of his city, his country, and even his patients, despite acknowledging that his surgical hands are now trained to use a machine gun.
“It’s not as bad as last week,” he laughs, explaining that residents of Kyiv are more relaxed now, despite the air raid sirens, because the city’s anti-missile system has thus far kept them safe.
Even still, missiles have continued hitting civilian residences and Dr. Stakhovskyi, a urologic-oncology surgeon, has evacuated his wife and children out of the country, as have 70% of his colleagues. But for those who stayed in Kyiv, there is a strong resolve.
“People working in IT, in law, in other professions — they just took the guns and stayed in Kyiv,” he said in an interview. “They are just civilians, armed, trying to protect and fortify Kyiv — to make it unbreakable.”
Dr. Stakhovskyi doesn’t have a background in the military, but he now knows how to use a machine gun. “I am a super-specialized oncologist, [but] I realize if I leave right now it will give the Russians momentum to come in. The longer it takes, the weaker the opponent army will become, and we are more and more optimistic,” he said.
In Kyiv, Dr. Stakhovskyi is working half the time at the cancer hospital and the other half at the nearby military hospital, but he said so far war casualties are minimal within the city, and even the flow of patients with cancer has reduced.
“I had my surgeries planned up until the end of March, but when the war started, they were all postponed,” he said. Emergency cancer surgeries have continued, and now there is talk of resuming some others. “We will stratify patients into categories based on need,” he said. “For those patients whose surgery can basically stop the disease and they don’t need neoadjuvant chemo, we’ll probably be doing those.”
Medical oncology clinics have also resumed, said Dr. Stakhovskyi, but the volume of patients is low, because many have left the city. An estimated 3.3 million people have left Ukraine since the Russian invasion on February 24.
Across the country, in Lviv near the Polish border, another surgical oncologist tells a different story. Andriy Hrynkiv, MD, from Lviv Regional Cancer Center, says his hospital has seen a dramatic increase in patients, displaced internally from areas where the medical infrastructure has collapsed.
“Russian forces have destroyed more than 117 hospitals, 43 ambulances have been shot at, 6 doctors have been killed, and 13 wounded,” Dr. Hrynkiv said. In the city of Mariupol, “doctors and patients have been taken hostage,” he said, used by Russian forces as a human shield. In Kharkiv, with approximately 1.5 million residents, the only oncologic hospital has been destroyed.
There is a shortage and instability of medical supplies including all iodine-containing medications that citizens are stocking up on in the face of a potential nuclear attack, he said.
Dr. Hrynkiv was speaking on a webcast organized by the American Society of Clinical Oncology (ASCO) and European Cancer Organisation (ECO).
The two organizations are collaborating with each other and the World Health Organization to create a special network that is aiming to connect professionals, academic and clinical centers, and patient groups.
Additionally, the Ukranian Society of Clinical Oncology (USCO), cofounded by Dr. Stakhovskyi, is trying to keep patients connected with nongovernment organizations.
“These patient organizations moved west when the war started, but they still use us to help them make contact with foreign doctors,” he said. “We have tried to centralize this process but it’s very difficult because patients and organizations are also calling doctors and centers directly looking for treatment options.”
He says USCO is also coordinating the distribution of a donation of immunotherapy pembrolizumab (Keytruda) from pharmaceutical company Merck Sharp & Dohme. “It’s a huge influx of this drug,” he says. “They’ve promised something like 2,000 doses to cover 230 patients for 3 months at least. Usually this is not an easy drug to access for people in Ukraine because it’s really expensive.”
Dr. Stakhovskyi said the optimism he feels is fueled by the support that Ukrainians feel from the rest of the world.
“We see the reaction of our international colleagues. It is so impressive and touching — lots of my ex-professors are texting me and sending me messages from all over the place, from Germany, from Canada, from France, from the United States,” he said. “And if we can be optimistic for ourselves, definitely that translates to our patients.”
A version of this article first appeared on Medscape.com.
Yes, Russian docs should be shut out of medical associations, says ethicist
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the division of medical ethics at the NYU Grossman School of Medicine.
There are many difficult moral issues that are being fueled by the terrible war that Russia is waging against Ukraine. I think there is no way to justify anything that the Russians are doing. Ukraine did not do anything to violate Russian integrity, Russian territorial integrity, or anything by way of being aggressive toward Russia.
Russia decided at some point it wanted the Ukraine back. Putin has a dream, as the long-standing leader of Russia, to restore the Soviet empire, and Ukraine is top of the list of the places that he wants back for a variety of reasons.
We’re not here to debate the merits and demerits of this terrible act of war.
The European Society of Cardiology made a decision very recently to drop, as members, both Russia and Belarus, Russia’s ally in this aggressive war against Ukraine. They basically found it intolerable to have business as usual with these subsidiary cardiology societies as part of the ongoing activities of the European group.
The sole goal of this overarching European group is to reduce the health burden of cardiovascular disease. It doesn’t have political goals. It doesn’t have much to say about anything other than, “Let’s get evidence-based medicine used to try and prevent heart disease or treat heart disease.” So there’s noble intent.
Many of its members asked, “What are we doing in politics? Why are we punishing Russian and Belarussian cardiologists, acting as if somehow they are responsible for what the Russian army is doing or for what Putin has decided to do? Why are we acting against them? They are just trying to fight heart disease. That’s a legitimate goal for any doctor, public health official, or scientist.” They didn’t see, as members, why this exclusion had taken place.
I believe the exclusion is appropriate and some of the membership, obviously, in the European Society of Cardiology, agrees. It’s not because they’re holding doctors or scientists directly accountable for Putin’s war crimes, ethnic cleansing assault, or bombing and shelling of hospitals, maternity hospitals, and civilians.
They understand that these scientists and doctors have little to do with such things, but we are in a new form of warfare, and that warfare is basically economic and sociologic: turning Russia, as an inexcusably aggressive state, into a pariah.
The reason to break the ties is that that is the way to bring pressure upon Putin and his kleptocratic, oligarchic advisers to stop the attack, to try and bring down their economy, to say, “Business is not going to go on as usual. You will be excluded from normal scientific and medical commerce. We’re not going to be holding conferences or exchanging ideas,” and in my view, extending it to say, “We’re not taking your papers, we’re not publishing anything you do. We’re not even having you speak at our meetings until this war, this aggressive invasion, and these war crimes come to a halt.”
There is actually a basis for this action. It isn’t in the organization’s own bylaws, which as I said, are very simple — reduce cardiovascular disease burden — but they are a member of a broader group, the Biomedical Alliance in Europe, which does have a very explicit code of ethics.
I’m going to read you a little bit from that code. It says healthcare organizations should uphold and promote equality, diversity and inclusion, accountability, transparency, and equality. They also say that all members, including the European Society of Cardiology, should be committed both to the Declaration of Helsinki, a fundamental medical ethics document, and the Declaration of Geneva. These rules refer to the highest respect of human beings, responsible resource allocation, and preservation of the environment, among other things.
What the organization is doing is consistent with the code of ethics that the broader organization of all the medical societies of Europe say that these individual groups should be doing. You can’t collaborate with war criminals. You can’t act as if business as usual is going on. That’s not inclusive. That’s not respect for diversity.
I think the Ukrainian medical societies of cardiology and other specialties would find it grimly ironic to say that keeping Russian and Belarus members makes sense, given what’s going on in their country and what is happening to them. They’re under attack. They’re being killed. Their healthcare institutions are being indiscriminately shelled and bombed.
It’s very hard — and I understand that — to say we’re going to punish scientists. We’re going to, perhaps, even cause public health problems in Russia because we’re not going to collaborate right now with doctors and scientists in cardiology or any other medical specialty. I think it’s what has to be done.
We’re in a new era of trying to combat what is basically organized, international ethnic terrorism, complete with war crimes. We fight financially. We fight by isolating. We fight by excluding. It’s painful. It’s difficult. It’s somewhat unfair to individuals.
Only through that kind of pain are we going to get the kind of pressure that will achieve justice. I think that is a goal that we have to commend the European Society of Cardiology for honoring.
Dr. Caplan is director of the division of medical ethics at New York University. He is the author or editor of 35 books and 750 peer-reviewed articles as well as a frequent commentator in the media on bioethical issues. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (an unpaid position), and is a contributing author and adviser for Medscape. A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the division of medical ethics at the NYU Grossman School of Medicine.
There are many difficult moral issues that are being fueled by the terrible war that Russia is waging against Ukraine. I think there is no way to justify anything that the Russians are doing. Ukraine did not do anything to violate Russian integrity, Russian territorial integrity, or anything by way of being aggressive toward Russia.
Russia decided at some point it wanted the Ukraine back. Putin has a dream, as the long-standing leader of Russia, to restore the Soviet empire, and Ukraine is top of the list of the places that he wants back for a variety of reasons.
We’re not here to debate the merits and demerits of this terrible act of war.
The European Society of Cardiology made a decision very recently to drop, as members, both Russia and Belarus, Russia’s ally in this aggressive war against Ukraine. They basically found it intolerable to have business as usual with these subsidiary cardiology societies as part of the ongoing activities of the European group.
The sole goal of this overarching European group is to reduce the health burden of cardiovascular disease. It doesn’t have political goals. It doesn’t have much to say about anything other than, “Let’s get evidence-based medicine used to try and prevent heart disease or treat heart disease.” So there’s noble intent.
Many of its members asked, “What are we doing in politics? Why are we punishing Russian and Belarussian cardiologists, acting as if somehow they are responsible for what the Russian army is doing or for what Putin has decided to do? Why are we acting against them? They are just trying to fight heart disease. That’s a legitimate goal for any doctor, public health official, or scientist.” They didn’t see, as members, why this exclusion had taken place.
I believe the exclusion is appropriate and some of the membership, obviously, in the European Society of Cardiology, agrees. It’s not because they’re holding doctors or scientists directly accountable for Putin’s war crimes, ethnic cleansing assault, or bombing and shelling of hospitals, maternity hospitals, and civilians.
They understand that these scientists and doctors have little to do with such things, but we are in a new form of warfare, and that warfare is basically economic and sociologic: turning Russia, as an inexcusably aggressive state, into a pariah.
The reason to break the ties is that that is the way to bring pressure upon Putin and his kleptocratic, oligarchic advisers to stop the attack, to try and bring down their economy, to say, “Business is not going to go on as usual. You will be excluded from normal scientific and medical commerce. We’re not going to be holding conferences or exchanging ideas,” and in my view, extending it to say, “We’re not taking your papers, we’re not publishing anything you do. We’re not even having you speak at our meetings until this war, this aggressive invasion, and these war crimes come to a halt.”
There is actually a basis for this action. It isn’t in the organization’s own bylaws, which as I said, are very simple — reduce cardiovascular disease burden — but they are a member of a broader group, the Biomedical Alliance in Europe, which does have a very explicit code of ethics.
I’m going to read you a little bit from that code. It says healthcare organizations should uphold and promote equality, diversity and inclusion, accountability, transparency, and equality. They also say that all members, including the European Society of Cardiology, should be committed both to the Declaration of Helsinki, a fundamental medical ethics document, and the Declaration of Geneva. These rules refer to the highest respect of human beings, responsible resource allocation, and preservation of the environment, among other things.
What the organization is doing is consistent with the code of ethics that the broader organization of all the medical societies of Europe say that these individual groups should be doing. You can’t collaborate with war criminals. You can’t act as if business as usual is going on. That’s not inclusive. That’s not respect for diversity.
I think the Ukrainian medical societies of cardiology and other specialties would find it grimly ironic to say that keeping Russian and Belarus members makes sense, given what’s going on in their country and what is happening to them. They’re under attack. They’re being killed. Their healthcare institutions are being indiscriminately shelled and bombed.
It’s very hard — and I understand that — to say we’re going to punish scientists. We’re going to, perhaps, even cause public health problems in Russia because we’re not going to collaborate right now with doctors and scientists in cardiology or any other medical specialty. I think it’s what has to be done.
We’re in a new era of trying to combat what is basically organized, international ethnic terrorism, complete with war crimes. We fight financially. We fight by isolating. We fight by excluding. It’s painful. It’s difficult. It’s somewhat unfair to individuals.
Only through that kind of pain are we going to get the kind of pressure that will achieve justice. I think that is a goal that we have to commend the European Society of Cardiology for honoring.
Dr. Caplan is director of the division of medical ethics at New York University. He is the author or editor of 35 books and 750 peer-reviewed articles as well as a frequent commentator in the media on bioethical issues. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (an unpaid position), and is a contributing author and adviser for Medscape. A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. I’m Art Caplan. I’m at the division of medical ethics at the NYU Grossman School of Medicine.
There are many difficult moral issues that are being fueled by the terrible war that Russia is waging against Ukraine. I think there is no way to justify anything that the Russians are doing. Ukraine did not do anything to violate Russian integrity, Russian territorial integrity, or anything by way of being aggressive toward Russia.
Russia decided at some point it wanted the Ukraine back. Putin has a dream, as the long-standing leader of Russia, to restore the Soviet empire, and Ukraine is top of the list of the places that he wants back for a variety of reasons.
We’re not here to debate the merits and demerits of this terrible act of war.
The European Society of Cardiology made a decision very recently to drop, as members, both Russia and Belarus, Russia’s ally in this aggressive war against Ukraine. They basically found it intolerable to have business as usual with these subsidiary cardiology societies as part of the ongoing activities of the European group.
The sole goal of this overarching European group is to reduce the health burden of cardiovascular disease. It doesn’t have political goals. It doesn’t have much to say about anything other than, “Let’s get evidence-based medicine used to try and prevent heart disease or treat heart disease.” So there’s noble intent.
Many of its members asked, “What are we doing in politics? Why are we punishing Russian and Belarussian cardiologists, acting as if somehow they are responsible for what the Russian army is doing or for what Putin has decided to do? Why are we acting against them? They are just trying to fight heart disease. That’s a legitimate goal for any doctor, public health official, or scientist.” They didn’t see, as members, why this exclusion had taken place.
I believe the exclusion is appropriate and some of the membership, obviously, in the European Society of Cardiology, agrees. It’s not because they’re holding doctors or scientists directly accountable for Putin’s war crimes, ethnic cleansing assault, or bombing and shelling of hospitals, maternity hospitals, and civilians.
They understand that these scientists and doctors have little to do with such things, but we are in a new form of warfare, and that warfare is basically economic and sociologic: turning Russia, as an inexcusably aggressive state, into a pariah.
The reason to break the ties is that that is the way to bring pressure upon Putin and his kleptocratic, oligarchic advisers to stop the attack, to try and bring down their economy, to say, “Business is not going to go on as usual. You will be excluded from normal scientific and medical commerce. We’re not going to be holding conferences or exchanging ideas,” and in my view, extending it to say, “We’re not taking your papers, we’re not publishing anything you do. We’re not even having you speak at our meetings until this war, this aggressive invasion, and these war crimes come to a halt.”
There is actually a basis for this action. It isn’t in the organization’s own bylaws, which as I said, are very simple — reduce cardiovascular disease burden — but they are a member of a broader group, the Biomedical Alliance in Europe, which does have a very explicit code of ethics.
I’m going to read you a little bit from that code. It says healthcare organizations should uphold and promote equality, diversity and inclusion, accountability, transparency, and equality. They also say that all members, including the European Society of Cardiology, should be committed both to the Declaration of Helsinki, a fundamental medical ethics document, and the Declaration of Geneva. These rules refer to the highest respect of human beings, responsible resource allocation, and preservation of the environment, among other things.
What the organization is doing is consistent with the code of ethics that the broader organization of all the medical societies of Europe say that these individual groups should be doing. You can’t collaborate with war criminals. You can’t act as if business as usual is going on. That’s not inclusive. That’s not respect for diversity.
I think the Ukrainian medical societies of cardiology and other specialties would find it grimly ironic to say that keeping Russian and Belarus members makes sense, given what’s going on in their country and what is happening to them. They’re under attack. They’re being killed. Their healthcare institutions are being indiscriminately shelled and bombed.
It’s very hard — and I understand that — to say we’re going to punish scientists. We’re going to, perhaps, even cause public health problems in Russia because we’re not going to collaborate right now with doctors and scientists in cardiology or any other medical specialty. I think it’s what has to be done.
We’re in a new era of trying to combat what is basically organized, international ethnic terrorism, complete with war crimes. We fight financially. We fight by isolating. We fight by excluding. It’s painful. It’s difficult. It’s somewhat unfair to individuals.
Only through that kind of pain are we going to get the kind of pressure that will achieve justice. I think that is a goal that we have to commend the European Society of Cardiology for honoring.
Dr. Caplan is director of the division of medical ethics at New York University. He is the author or editor of 35 books and 750 peer-reviewed articles as well as a frequent commentator in the media on bioethical issues. He has served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (an unpaid position), and is a contributing author and adviser for Medscape. A version of this article first appeared on Medscape.com.
Lancet Commission reexamines the current approach to death
“The story of dying in the 21st century is a story of paradox.” This is the opening line of a report recently published in the Lancet, in which the Lancet Commission experts tackle what is, for many, a very sensitive topic: the end of life. The recommendations they present aim at “bringing death back into life.”
What makes the story a paradox is that, in end-of-life situations, many people are overtreated, and on the other hand, many people are undertreated.
In short, when all is said and done, “people die bad deaths.” A natural event, a natural part of life, has turned into something that people fear or, in some cases, refuse to even acknowledge or talk about.
This was the motivating factor for the Lancet Commission, a group of experts from various disciplines, to come together to try to better understand this complex concept. , as well as a balance between life and death.
This sensitive topic was explored by Marina Sozzi, PhD. She is the director of the Association for the Support and Assistance of People With Chronic and Oncological Diseases, a nonprofit organization that for more than 30 years has been dedicated to “providing palliative care and supporting individuals with oncological or other chronic and degenerative diseases.”
Call for rebalancing
To give people an idea of a better system in which life and death are in balance, the Lancet Commission experts described a realistic utopia, which they summarized in the following five principles:
- The social determinants of death, dying, and grieving are confronted.
- Dying is understood to be a relational and spiritual process rather than simply a physiological event.
- Networks of care provide support for people who are dying, those caring for them, and those grieving.
- Conversations and stories about everyday death, dying, and grief become common.
- Death is recognized as having value.
Achieving this utopia will not be easy, especially considering the current systems that are in place. “There have been tremendous medical advances over the last hundred years, particularly in increasing life expectancy and curing diseases that were once considered death sentences,” Dr. Sozzi explained. “Indeed, over the course of that time period, medical science acquired an enormous degree of social power, and matters of death – which in previous centuries had been within the purview of religions and houses of worship – were handed over to be handled by doctors and nurses.”
The COVID-19 pandemic has made the medical field’s role in matters of death more prominent: every day, people saw footage of dying people in hospital beds being cared for by health care professionals in masks and gowns. These patients were otherwise alone, their only contact with loved ones being over the phone or online. They died the ultimate medicalized deaths, stripped of almost all opportunities to get emotional support from family and friends.
New perspective needed
The Lancet Commission experts were certain about one point: The need to move away from the reductionist approach to death in order to integrate a more holistic approach, one that takes into account all of the dimensions of death without limiting itself only to the medical aspects.
“Medicine has its own take on the death phenomenon and on disease, which is a reductionist take,” said Dr. Sozzi, noting that, thanks to processes that make it possible to reduce phenomena to the measurable, medicine has managed to make tremendous progress. The same approach has been applied to the view of death, which has by and large become a biologic event.
“The problem is that, in reality, death is a much more complex phenomenon: cultural, social, involving families and society,” she explained. “Not all of these aspects are taken into consideration by medicine, and therefore, our culture has diminished its view of the death phenomenon.” Dr. Sozzi pointed out that, if looked upon more closely, the very question: “What did the person die of?” presupposes, in a certain sense, that it might have been possible to prevent that death – if only medicine had the right technology. So, death comes to be seen as something that could have been avoided.
Power of palliative care
Changing the approach to death requires a profound culture shift and, therefore, a lot of time. The good news is that, although there is still a long way to go, a few steps have been taken in this direction. “Talking about death, and even organizing courses aimed at health care professionals, is definitely easier these days than it was even just 10 years ago,” said Dr. Sozzi, citing, as an example, a project she developed for training nursing home operators in palliative care.
It is in palliative care where the greatest progress has been made in end-of-life matters. “The culture of palliative care allows us to think about death in very different terms and to recognize that moment when we should stop looking at curative care and direct our efforts at ‘comfort care.’ And this care of the dying has to be holistic,” Dr. Sozzi explained. She adds that we are increasingly talking about simultaneous palliative care – care that is not limited to the final days of a person’s life but that rather starts early on, when active treatments are still in place.
Dr. Sozzi mentioned Italy’s Law 38, which took effect in 2010. It regulates access to palliative care and pain management, expanding the right to receive these treatments to patients “in any health care setting, at any stage of life, and for any chronic or progressive condition which has no treatment or has a treatment that is not sufficient to stabilize it.”
A culture shift is also needed in this area; there has already been a movement away from general practitioners to health care professionals who can and must direct a patient to palliative care.
“We need to provide these doctors with more training and make them more aware of what a difference this kind of care can make throughout a patient’s life, not only during the final stages,” said Dr. Sozzi. Concerning training, she mentioned that Italy had recently introduced a specialization in palliative care for medical school graduates. This is another small step and one that adds a sense of dignity to this new approach to life and to death.
The experts’ recommendations
In attempting to find a balance between life and death, we must not look at the period prior to the 1900s as some kind of golden age. Dr. Sozzi explained that back then there was almost none of the medical technology now available to treat people at the end of life. “Palliative care has also set forth original technical aspects for eliminating pain. Without having eliminated a patient’s pain, I can hardly begin a discussion with them about spiritual aspects,” she said, emphasizing the importance of always contextualizing approaches to death.
The Lancet Commission experts assessed the approach to death in many different contexts. They recommended that, to best handle end-of-life matters in all their complexity, one should keep in mind the importance of relationships and networks across society.
They recommended that health care and social care professionals improve their skills and their capacity for taking care of dying patients and their families. When the patient has a life-limiting illness, a caring and compassionate approach should be taken when providing clear information about all interventions involved in palliative care, as well as when having conversations about death.
Governments and policy makers are advised to implement actions to allow all citizens to have the same access to necessary palliative care. In addition, all strategies and reports on social care and well-being more broadly should always include consideration of death, dying, and grieving. It’s an uphill climb, but one that must be made if we’re to build a new culture aimed at bringing death back into life. “As we continue stepping toward this new culture, let us each put a stone in place,” Dr. Sozzi concluded.
A version of this article first appeared on Medscape.com.
“The story of dying in the 21st century is a story of paradox.” This is the opening line of a report recently published in the Lancet, in which the Lancet Commission experts tackle what is, for many, a very sensitive topic: the end of life. The recommendations they present aim at “bringing death back into life.”
What makes the story a paradox is that, in end-of-life situations, many people are overtreated, and on the other hand, many people are undertreated.
In short, when all is said and done, “people die bad deaths.” A natural event, a natural part of life, has turned into something that people fear or, in some cases, refuse to even acknowledge or talk about.
This was the motivating factor for the Lancet Commission, a group of experts from various disciplines, to come together to try to better understand this complex concept. , as well as a balance between life and death.
This sensitive topic was explored by Marina Sozzi, PhD. She is the director of the Association for the Support and Assistance of People With Chronic and Oncological Diseases, a nonprofit organization that for more than 30 years has been dedicated to “providing palliative care and supporting individuals with oncological or other chronic and degenerative diseases.”
Call for rebalancing
To give people an idea of a better system in which life and death are in balance, the Lancet Commission experts described a realistic utopia, which they summarized in the following five principles:
- The social determinants of death, dying, and grieving are confronted.
- Dying is understood to be a relational and spiritual process rather than simply a physiological event.
- Networks of care provide support for people who are dying, those caring for them, and those grieving.
- Conversations and stories about everyday death, dying, and grief become common.
- Death is recognized as having value.
Achieving this utopia will not be easy, especially considering the current systems that are in place. “There have been tremendous medical advances over the last hundred years, particularly in increasing life expectancy and curing diseases that were once considered death sentences,” Dr. Sozzi explained. “Indeed, over the course of that time period, medical science acquired an enormous degree of social power, and matters of death – which in previous centuries had been within the purview of religions and houses of worship – were handed over to be handled by doctors and nurses.”
The COVID-19 pandemic has made the medical field’s role in matters of death more prominent: every day, people saw footage of dying people in hospital beds being cared for by health care professionals in masks and gowns. These patients were otherwise alone, their only contact with loved ones being over the phone or online. They died the ultimate medicalized deaths, stripped of almost all opportunities to get emotional support from family and friends.
New perspective needed
The Lancet Commission experts were certain about one point: The need to move away from the reductionist approach to death in order to integrate a more holistic approach, one that takes into account all of the dimensions of death without limiting itself only to the medical aspects.
“Medicine has its own take on the death phenomenon and on disease, which is a reductionist take,” said Dr. Sozzi, noting that, thanks to processes that make it possible to reduce phenomena to the measurable, medicine has managed to make tremendous progress. The same approach has been applied to the view of death, which has by and large become a biologic event.
“The problem is that, in reality, death is a much more complex phenomenon: cultural, social, involving families and society,” she explained. “Not all of these aspects are taken into consideration by medicine, and therefore, our culture has diminished its view of the death phenomenon.” Dr. Sozzi pointed out that, if looked upon more closely, the very question: “What did the person die of?” presupposes, in a certain sense, that it might have been possible to prevent that death – if only medicine had the right technology. So, death comes to be seen as something that could have been avoided.
Power of palliative care
Changing the approach to death requires a profound culture shift and, therefore, a lot of time. The good news is that, although there is still a long way to go, a few steps have been taken in this direction. “Talking about death, and even organizing courses aimed at health care professionals, is definitely easier these days than it was even just 10 years ago,” said Dr. Sozzi, citing, as an example, a project she developed for training nursing home operators in palliative care.
It is in palliative care where the greatest progress has been made in end-of-life matters. “The culture of palliative care allows us to think about death in very different terms and to recognize that moment when we should stop looking at curative care and direct our efforts at ‘comfort care.’ And this care of the dying has to be holistic,” Dr. Sozzi explained. She adds that we are increasingly talking about simultaneous palliative care – care that is not limited to the final days of a person’s life but that rather starts early on, when active treatments are still in place.
Dr. Sozzi mentioned Italy’s Law 38, which took effect in 2010. It regulates access to palliative care and pain management, expanding the right to receive these treatments to patients “in any health care setting, at any stage of life, and for any chronic or progressive condition which has no treatment or has a treatment that is not sufficient to stabilize it.”
A culture shift is also needed in this area; there has already been a movement away from general practitioners to health care professionals who can and must direct a patient to palliative care.
“We need to provide these doctors with more training and make them more aware of what a difference this kind of care can make throughout a patient’s life, not only during the final stages,” said Dr. Sozzi. Concerning training, she mentioned that Italy had recently introduced a specialization in palliative care for medical school graduates. This is another small step and one that adds a sense of dignity to this new approach to life and to death.
The experts’ recommendations
In attempting to find a balance between life and death, we must not look at the period prior to the 1900s as some kind of golden age. Dr. Sozzi explained that back then there was almost none of the medical technology now available to treat people at the end of life. “Palliative care has also set forth original technical aspects for eliminating pain. Without having eliminated a patient’s pain, I can hardly begin a discussion with them about spiritual aspects,” she said, emphasizing the importance of always contextualizing approaches to death.
The Lancet Commission experts assessed the approach to death in many different contexts. They recommended that, to best handle end-of-life matters in all their complexity, one should keep in mind the importance of relationships and networks across society.
They recommended that health care and social care professionals improve their skills and their capacity for taking care of dying patients and their families. When the patient has a life-limiting illness, a caring and compassionate approach should be taken when providing clear information about all interventions involved in palliative care, as well as when having conversations about death.
Governments and policy makers are advised to implement actions to allow all citizens to have the same access to necessary palliative care. In addition, all strategies and reports on social care and well-being more broadly should always include consideration of death, dying, and grieving. It’s an uphill climb, but one that must be made if we’re to build a new culture aimed at bringing death back into life. “As we continue stepping toward this new culture, let us each put a stone in place,” Dr. Sozzi concluded.
A version of this article first appeared on Medscape.com.
“The story of dying in the 21st century is a story of paradox.” This is the opening line of a report recently published in the Lancet, in which the Lancet Commission experts tackle what is, for many, a very sensitive topic: the end of life. The recommendations they present aim at “bringing death back into life.”
What makes the story a paradox is that, in end-of-life situations, many people are overtreated, and on the other hand, many people are undertreated.
In short, when all is said and done, “people die bad deaths.” A natural event, a natural part of life, has turned into something that people fear or, in some cases, refuse to even acknowledge or talk about.
This was the motivating factor for the Lancet Commission, a group of experts from various disciplines, to come together to try to better understand this complex concept. , as well as a balance between life and death.
This sensitive topic was explored by Marina Sozzi, PhD. She is the director of the Association for the Support and Assistance of People With Chronic and Oncological Diseases, a nonprofit organization that for more than 30 years has been dedicated to “providing palliative care and supporting individuals with oncological or other chronic and degenerative diseases.”
Call for rebalancing
To give people an idea of a better system in which life and death are in balance, the Lancet Commission experts described a realistic utopia, which they summarized in the following five principles:
- The social determinants of death, dying, and grieving are confronted.
- Dying is understood to be a relational and spiritual process rather than simply a physiological event.
- Networks of care provide support for people who are dying, those caring for them, and those grieving.
- Conversations and stories about everyday death, dying, and grief become common.
- Death is recognized as having value.
Achieving this utopia will not be easy, especially considering the current systems that are in place. “There have been tremendous medical advances over the last hundred years, particularly in increasing life expectancy and curing diseases that were once considered death sentences,” Dr. Sozzi explained. “Indeed, over the course of that time period, medical science acquired an enormous degree of social power, and matters of death – which in previous centuries had been within the purview of religions and houses of worship – were handed over to be handled by doctors and nurses.”
The COVID-19 pandemic has made the medical field’s role in matters of death more prominent: every day, people saw footage of dying people in hospital beds being cared for by health care professionals in masks and gowns. These patients were otherwise alone, their only contact with loved ones being over the phone or online. They died the ultimate medicalized deaths, stripped of almost all opportunities to get emotional support from family and friends.
New perspective needed
The Lancet Commission experts were certain about one point: The need to move away from the reductionist approach to death in order to integrate a more holistic approach, one that takes into account all of the dimensions of death without limiting itself only to the medical aspects.
“Medicine has its own take on the death phenomenon and on disease, which is a reductionist take,” said Dr. Sozzi, noting that, thanks to processes that make it possible to reduce phenomena to the measurable, medicine has managed to make tremendous progress. The same approach has been applied to the view of death, which has by and large become a biologic event.
“The problem is that, in reality, death is a much more complex phenomenon: cultural, social, involving families and society,” she explained. “Not all of these aspects are taken into consideration by medicine, and therefore, our culture has diminished its view of the death phenomenon.” Dr. Sozzi pointed out that, if looked upon more closely, the very question: “What did the person die of?” presupposes, in a certain sense, that it might have been possible to prevent that death – if only medicine had the right technology. So, death comes to be seen as something that could have been avoided.
Power of palliative care
Changing the approach to death requires a profound culture shift and, therefore, a lot of time. The good news is that, although there is still a long way to go, a few steps have been taken in this direction. “Talking about death, and even organizing courses aimed at health care professionals, is definitely easier these days than it was even just 10 years ago,” said Dr. Sozzi, citing, as an example, a project she developed for training nursing home operators in palliative care.
It is in palliative care where the greatest progress has been made in end-of-life matters. “The culture of palliative care allows us to think about death in very different terms and to recognize that moment when we should stop looking at curative care and direct our efforts at ‘comfort care.’ And this care of the dying has to be holistic,” Dr. Sozzi explained. She adds that we are increasingly talking about simultaneous palliative care – care that is not limited to the final days of a person’s life but that rather starts early on, when active treatments are still in place.
Dr. Sozzi mentioned Italy’s Law 38, which took effect in 2010. It regulates access to palliative care and pain management, expanding the right to receive these treatments to patients “in any health care setting, at any stage of life, and for any chronic or progressive condition which has no treatment or has a treatment that is not sufficient to stabilize it.”
A culture shift is also needed in this area; there has already been a movement away from general practitioners to health care professionals who can and must direct a patient to palliative care.
“We need to provide these doctors with more training and make them more aware of what a difference this kind of care can make throughout a patient’s life, not only during the final stages,” said Dr. Sozzi. Concerning training, she mentioned that Italy had recently introduced a specialization in palliative care for medical school graduates. This is another small step and one that adds a sense of dignity to this new approach to life and to death.
The experts’ recommendations
In attempting to find a balance between life and death, we must not look at the period prior to the 1900s as some kind of golden age. Dr. Sozzi explained that back then there was almost none of the medical technology now available to treat people at the end of life. “Palliative care has also set forth original technical aspects for eliminating pain. Without having eliminated a patient’s pain, I can hardly begin a discussion with them about spiritual aspects,” she said, emphasizing the importance of always contextualizing approaches to death.
The Lancet Commission experts assessed the approach to death in many different contexts. They recommended that, to best handle end-of-life matters in all their complexity, one should keep in mind the importance of relationships and networks across society.
They recommended that health care and social care professionals improve their skills and their capacity for taking care of dying patients and their families. When the patient has a life-limiting illness, a caring and compassionate approach should be taken when providing clear information about all interventions involved in palliative care, as well as when having conversations about death.
Governments and policy makers are advised to implement actions to allow all citizens to have the same access to necessary palliative care. In addition, all strategies and reports on social care and well-being more broadly should always include consideration of death, dying, and grieving. It’s an uphill climb, but one that must be made if we’re to build a new culture aimed at bringing death back into life. “As we continue stepping toward this new culture, let us each put a stone in place,” Dr. Sozzi concluded.
A version of this article first appeared on Medscape.com.
FROM THE LANCET
‘It’s about transparency’: Indiana law prohibits misleading medical titles
While several health care professionals can perform some of the same functions as physicians, at the end of the day, they are not MDs or DOs, nor do they have the education and training to earn the right to present themselves to patients as such. That’s the reasoning behind Senate Bill 239, recently signed into law by Indiana Gov. Eric J. Holcomb.
“It’s about transparency. Health care professionals at every level should be proud of their profession and want to help patients make an informed choice when seeking out options for treatment,” Carrie Davis, MD, a Bloomington, Ind.–based dermatologist and member of the Indiana State Medical Association’s commission on legislation, told this news organization. “When this law goes into effect, a patient will be able to seek that treatment with confidence knowing they can trust the education, training, and license of the health care expert they’ve chosen to see.”
such as anesthesiologist, cardiologist, dermatologist, and others by professionals who have not graduated from medical school and completed the necessary training to adopt the physician title. It also prohibits health care professionals from using deceptive or misleading advertising that misrepresents or falsely describes their profession, education, or skills.
“Using the medical term ‘anesthesiologist’ for nurse anesthetists, confuses patients who deserve to be fully informed of their health care provider’s qualifications,” Randall M. Clark, MD, president of the American Society of Anesthesiologists (ASA), said in a statement. “This new law affirms the most fundamental right of patients to know the qualifications of their health care professional.”
What’s in a title?
The problem stretches far beyond professional turf battles, as patients are often confused about the differences between various types of health care providers, according to the American Medical Association’s Truth in Advertising Campaign. Often, patients mistakenly believe they are meeting with medical doctors or doctors of osteopathic medicine when they are not.
Seung Sim, MD, an Indiana anesthesiologist and the immediate past president of the Indiana Society of Anesthesiologists, said in an interview that every member of the medical team plays an important role in high-quality patient care, but among that team, education and training differs.
“The threat to patient safety comes by nonphysicians marketing themselves in a way that is confusing to patients, and misleading, making the patient believe they’re seeing a physician when they’re not,” said Dr. Sim. “That patient deserves to know who is providing their health care and what level of education and training they have, so the patient can make the best decision for their treatment.”
Medical groups speak out
Several professional medical groups have voiced their opposition to medical title misappropriation.
Perhaps most notably, the ASA has been spearheading efforts that prohibit medical professionals to identify as physicians for several years. In 2019, the ASA authored Resolution 228, which calls on the AMA to oppose and work with state medical societies to prevent the misappropriation of medical specialties’ titles.
The resolution, which was adopted by the AMA in June 2019, also reaffirms support of the Scope of Practice Partnership’s Truth in Advertising Campaign to ensure patients receive accurate information about who is providing their care.
In addition, in 2021, the ASA condemned the decision by the American Association of Nurse Anesthetists to change its name to the American Association of Nurse Anesthesiology (AANA) – pointing out that the term “nurse anesthesiologist” could confuse patients and create discord in the care setting, ultimately risking patient safety.
While the ASA and other professional groups support team-based models of care, they are quick to point out that health care professionals need to know their place in the lineup.
A statement from the American Osteopathic Association (AOA), for instance, points out that only DOs and MDs can be licensed to practice medicine – and, therefore, “physician-led” should not mean “physician-optional.” In fact, only professionals who have earned the right to practice medicine through completion of medical school and accredited residency/fellowship training and who have achieved board certification in their chosen specialty/subspecialty should take the helm of these multidisciplinary teams, according to the AOA.
The AANA cast the controversy in a completely different light, characterizing its name change as part of a rebranding effort to advance the science of nurse anesthesiology and advocate for certified registered nurse anesthetists. In 2021, the AANA asserted: “The notion of being pushed by the American Society of Anesthesiologists that rebranding and changing the name of the AANA will somehow mislead or harm patients or create discord among providers is absurd at best and false and inflammatory fearmongering at worst.”
A version of this article first appeared on Medscape.com.
While several health care professionals can perform some of the same functions as physicians, at the end of the day, they are not MDs or DOs, nor do they have the education and training to earn the right to present themselves to patients as such. That’s the reasoning behind Senate Bill 239, recently signed into law by Indiana Gov. Eric J. Holcomb.
“It’s about transparency. Health care professionals at every level should be proud of their profession and want to help patients make an informed choice when seeking out options for treatment,” Carrie Davis, MD, a Bloomington, Ind.–based dermatologist and member of the Indiana State Medical Association’s commission on legislation, told this news organization. “When this law goes into effect, a patient will be able to seek that treatment with confidence knowing they can trust the education, training, and license of the health care expert they’ve chosen to see.”
such as anesthesiologist, cardiologist, dermatologist, and others by professionals who have not graduated from medical school and completed the necessary training to adopt the physician title. It also prohibits health care professionals from using deceptive or misleading advertising that misrepresents or falsely describes their profession, education, or skills.
“Using the medical term ‘anesthesiologist’ for nurse anesthetists, confuses patients who deserve to be fully informed of their health care provider’s qualifications,” Randall M. Clark, MD, president of the American Society of Anesthesiologists (ASA), said in a statement. “This new law affirms the most fundamental right of patients to know the qualifications of their health care professional.”
What’s in a title?
The problem stretches far beyond professional turf battles, as patients are often confused about the differences between various types of health care providers, according to the American Medical Association’s Truth in Advertising Campaign. Often, patients mistakenly believe they are meeting with medical doctors or doctors of osteopathic medicine when they are not.
Seung Sim, MD, an Indiana anesthesiologist and the immediate past president of the Indiana Society of Anesthesiologists, said in an interview that every member of the medical team plays an important role in high-quality patient care, but among that team, education and training differs.
“The threat to patient safety comes by nonphysicians marketing themselves in a way that is confusing to patients, and misleading, making the patient believe they’re seeing a physician when they’re not,” said Dr. Sim. “That patient deserves to know who is providing their health care and what level of education and training they have, so the patient can make the best decision for their treatment.”
Medical groups speak out
Several professional medical groups have voiced their opposition to medical title misappropriation.
Perhaps most notably, the ASA has been spearheading efforts that prohibit medical professionals to identify as physicians for several years. In 2019, the ASA authored Resolution 228, which calls on the AMA to oppose and work with state medical societies to prevent the misappropriation of medical specialties’ titles.
The resolution, which was adopted by the AMA in June 2019, also reaffirms support of the Scope of Practice Partnership’s Truth in Advertising Campaign to ensure patients receive accurate information about who is providing their care.
In addition, in 2021, the ASA condemned the decision by the American Association of Nurse Anesthetists to change its name to the American Association of Nurse Anesthesiology (AANA) – pointing out that the term “nurse anesthesiologist” could confuse patients and create discord in the care setting, ultimately risking patient safety.
While the ASA and other professional groups support team-based models of care, they are quick to point out that health care professionals need to know their place in the lineup.
A statement from the American Osteopathic Association (AOA), for instance, points out that only DOs and MDs can be licensed to practice medicine – and, therefore, “physician-led” should not mean “physician-optional.” In fact, only professionals who have earned the right to practice medicine through completion of medical school and accredited residency/fellowship training and who have achieved board certification in their chosen specialty/subspecialty should take the helm of these multidisciplinary teams, according to the AOA.
The AANA cast the controversy in a completely different light, characterizing its name change as part of a rebranding effort to advance the science of nurse anesthesiology and advocate for certified registered nurse anesthetists. In 2021, the AANA asserted: “The notion of being pushed by the American Society of Anesthesiologists that rebranding and changing the name of the AANA will somehow mislead or harm patients or create discord among providers is absurd at best and false and inflammatory fearmongering at worst.”
A version of this article first appeared on Medscape.com.
While several health care professionals can perform some of the same functions as physicians, at the end of the day, they are not MDs or DOs, nor do they have the education and training to earn the right to present themselves to patients as such. That’s the reasoning behind Senate Bill 239, recently signed into law by Indiana Gov. Eric J. Holcomb.
“It’s about transparency. Health care professionals at every level should be proud of their profession and want to help patients make an informed choice when seeking out options for treatment,” Carrie Davis, MD, a Bloomington, Ind.–based dermatologist and member of the Indiana State Medical Association’s commission on legislation, told this news organization. “When this law goes into effect, a patient will be able to seek that treatment with confidence knowing they can trust the education, training, and license of the health care expert they’ve chosen to see.”
such as anesthesiologist, cardiologist, dermatologist, and others by professionals who have not graduated from medical school and completed the necessary training to adopt the physician title. It also prohibits health care professionals from using deceptive or misleading advertising that misrepresents or falsely describes their profession, education, or skills.
“Using the medical term ‘anesthesiologist’ for nurse anesthetists, confuses patients who deserve to be fully informed of their health care provider’s qualifications,” Randall M. Clark, MD, president of the American Society of Anesthesiologists (ASA), said in a statement. “This new law affirms the most fundamental right of patients to know the qualifications of their health care professional.”
What’s in a title?
The problem stretches far beyond professional turf battles, as patients are often confused about the differences between various types of health care providers, according to the American Medical Association’s Truth in Advertising Campaign. Often, patients mistakenly believe they are meeting with medical doctors or doctors of osteopathic medicine when they are not.
Seung Sim, MD, an Indiana anesthesiologist and the immediate past president of the Indiana Society of Anesthesiologists, said in an interview that every member of the medical team plays an important role in high-quality patient care, but among that team, education and training differs.
“The threat to patient safety comes by nonphysicians marketing themselves in a way that is confusing to patients, and misleading, making the patient believe they’re seeing a physician when they’re not,” said Dr. Sim. “That patient deserves to know who is providing their health care and what level of education and training they have, so the patient can make the best decision for their treatment.”
Medical groups speak out
Several professional medical groups have voiced their opposition to medical title misappropriation.
Perhaps most notably, the ASA has been spearheading efforts that prohibit medical professionals to identify as physicians for several years. In 2019, the ASA authored Resolution 228, which calls on the AMA to oppose and work with state medical societies to prevent the misappropriation of medical specialties’ titles.
The resolution, which was adopted by the AMA in June 2019, also reaffirms support of the Scope of Practice Partnership’s Truth in Advertising Campaign to ensure patients receive accurate information about who is providing their care.
In addition, in 2021, the ASA condemned the decision by the American Association of Nurse Anesthetists to change its name to the American Association of Nurse Anesthesiology (AANA) – pointing out that the term “nurse anesthesiologist” could confuse patients and create discord in the care setting, ultimately risking patient safety.
While the ASA and other professional groups support team-based models of care, they are quick to point out that health care professionals need to know their place in the lineup.
A statement from the American Osteopathic Association (AOA), for instance, points out that only DOs and MDs can be licensed to practice medicine – and, therefore, “physician-led” should not mean “physician-optional.” In fact, only professionals who have earned the right to practice medicine through completion of medical school and accredited residency/fellowship training and who have achieved board certification in their chosen specialty/subspecialty should take the helm of these multidisciplinary teams, according to the AOA.
The AANA cast the controversy in a completely different light, characterizing its name change as part of a rebranding effort to advance the science of nurse anesthesiology and advocate for certified registered nurse anesthetists. In 2021, the AANA asserted: “The notion of being pushed by the American Society of Anesthesiologists that rebranding and changing the name of the AANA will somehow mislead or harm patients or create discord among providers is absurd at best and false and inflammatory fearmongering at worst.”
A version of this article first appeared on Medscape.com.
U.S. health officials tracking COVID-19 increase in U.K.
Daily cases counts have increased 38% in the past week, according to the latest data from the U.K. Health Security Agency. Hospitalizations are up about 25% as well.
“Over the last year or so, what happens in the U.K. usually happens here a few weeks later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told NPR.
“And right now, the U.K. is seeing somewhat of a rebound in cases,” he said.
Health officials in the United Kingdom have noted the latest increase is likely due to the contagious BA.2 Omicron subvariant, the recent loosening of coronavirus restrictions, and waning immunity from vaccinations and infections.
“All three of those factors we have here in the United States,” Dr. Fauci said. “So I would not be surprised if, in the next few weeks, we see either a plateauing … of cases or even [the curve] rebounds and slightly goes up.”
Right now, COVID-19 cases in the United Stastes have dropped to their lowest levels since July 2021, according to the latest Centers for Disease Control and Prevention data, with fewer than 30,000 daily cases. At the same time, the rate of decline in cases has slowed significantly and is beginning to plateau.
Public health experts are also pointing to wastewater surveillance data that shows an uptick in viral activity across the country. The CDC’s wastewater dashboard indicates that about 35% of sites that monitor wastewater are seeing an increase, with consistent growth in Florida, Rhode Island, and West Virginia.
“The power of wastewater surveillance is that it’s an early warning system,” Amy Kirby, the program lead for the CDC’s National Wastewater Surveillance System, told NPR.
“We are seeing evidence of increases in some communities across the country,” she said. “What looked like noise at the beginning of the week is starting to look like a true signal here at the end of the week.”
The wastewater system doesn’t distinguish between Omicron and subvariants such as BA.2. However, other CDC data has found an increase in BA.2 cases in the United States, making up about a quarter of new COVID-19 cases.
The BA.2 variant has roughly doubled each week for the last month, which means it could become the dominant coronavirus strain in the United States in coming weeks, according to USA Today. Cases appear to be spreading more quickly in the Northeast and West, making up about 39% of cases in New York and New Jersey last week.
BA.2 also accounts for nearly 39% of cases across the Northeast, including Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont, USA Today reported. In the West, which includes Arizona, California and Nevada, the subvariant makes up about 28% of new cases. In the upper West, which includes Alaska, Oregon and Washington, about 26% of cases are BA.2.
The good news is that BA.2 “doesn’t seem to evade our vaccines or immunity any more than the prior Omicron [variant]. And it doesn’t seem to lead to any more increased severity of disease,” Rochelle Walensky, MD, the CDC director, told NPR’s Morning Edition on March 18.
The effects of BA.2 will likely depend on the immunity profile in the United States, including how long it’s been since someone was vaccinated, boosted, or recovered from an infection, she said.
Health officials are watching other countries with BA.2 increases, such as Germany, Italy, and the Netherlands. Many European countries have been reporting an uptick but not implementing major restrictions or shutdowns, USA Today reported.
The BA.2 variant likely won’t lead to a major surge in severe disease or strict COVID-19 measures, Dr. Fauci told NPR, but some coronavirus protocols may need to be implemented again if cases grow dramatically.
“We must be ready to pivot and, if necessary, to go back to stricter mitigation with regard to masks,” he said.
A version of this article first appeared on WebMD.com.
Daily cases counts have increased 38% in the past week, according to the latest data from the U.K. Health Security Agency. Hospitalizations are up about 25% as well.
“Over the last year or so, what happens in the U.K. usually happens here a few weeks later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told NPR.
“And right now, the U.K. is seeing somewhat of a rebound in cases,” he said.
Health officials in the United Kingdom have noted the latest increase is likely due to the contagious BA.2 Omicron subvariant, the recent loosening of coronavirus restrictions, and waning immunity from vaccinations and infections.
“All three of those factors we have here in the United States,” Dr. Fauci said. “So I would not be surprised if, in the next few weeks, we see either a plateauing … of cases or even [the curve] rebounds and slightly goes up.”
Right now, COVID-19 cases in the United Stastes have dropped to their lowest levels since July 2021, according to the latest Centers for Disease Control and Prevention data, with fewer than 30,000 daily cases. At the same time, the rate of decline in cases has slowed significantly and is beginning to plateau.
Public health experts are also pointing to wastewater surveillance data that shows an uptick in viral activity across the country. The CDC’s wastewater dashboard indicates that about 35% of sites that monitor wastewater are seeing an increase, with consistent growth in Florida, Rhode Island, and West Virginia.
“The power of wastewater surveillance is that it’s an early warning system,” Amy Kirby, the program lead for the CDC’s National Wastewater Surveillance System, told NPR.
“We are seeing evidence of increases in some communities across the country,” she said. “What looked like noise at the beginning of the week is starting to look like a true signal here at the end of the week.”
The wastewater system doesn’t distinguish between Omicron and subvariants such as BA.2. However, other CDC data has found an increase in BA.2 cases in the United States, making up about a quarter of new COVID-19 cases.
The BA.2 variant has roughly doubled each week for the last month, which means it could become the dominant coronavirus strain in the United States in coming weeks, according to USA Today. Cases appear to be spreading more quickly in the Northeast and West, making up about 39% of cases in New York and New Jersey last week.
BA.2 also accounts for nearly 39% of cases across the Northeast, including Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont, USA Today reported. In the West, which includes Arizona, California and Nevada, the subvariant makes up about 28% of new cases. In the upper West, which includes Alaska, Oregon and Washington, about 26% of cases are BA.2.
The good news is that BA.2 “doesn’t seem to evade our vaccines or immunity any more than the prior Omicron [variant]. And it doesn’t seem to lead to any more increased severity of disease,” Rochelle Walensky, MD, the CDC director, told NPR’s Morning Edition on March 18.
The effects of BA.2 will likely depend on the immunity profile in the United States, including how long it’s been since someone was vaccinated, boosted, or recovered from an infection, she said.
Health officials are watching other countries with BA.2 increases, such as Germany, Italy, and the Netherlands. Many European countries have been reporting an uptick but not implementing major restrictions or shutdowns, USA Today reported.
The BA.2 variant likely won’t lead to a major surge in severe disease or strict COVID-19 measures, Dr. Fauci told NPR, but some coronavirus protocols may need to be implemented again if cases grow dramatically.
“We must be ready to pivot and, if necessary, to go back to stricter mitigation with regard to masks,” he said.
A version of this article first appeared on WebMD.com.
Daily cases counts have increased 38% in the past week, according to the latest data from the U.K. Health Security Agency. Hospitalizations are up about 25% as well.
“Over the last year or so, what happens in the U.K. usually happens here a few weeks later,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told NPR.
“And right now, the U.K. is seeing somewhat of a rebound in cases,” he said.
Health officials in the United Kingdom have noted the latest increase is likely due to the contagious BA.2 Omicron subvariant, the recent loosening of coronavirus restrictions, and waning immunity from vaccinations and infections.
“All three of those factors we have here in the United States,” Dr. Fauci said. “So I would not be surprised if, in the next few weeks, we see either a plateauing … of cases or even [the curve] rebounds and slightly goes up.”
Right now, COVID-19 cases in the United Stastes have dropped to their lowest levels since July 2021, according to the latest Centers for Disease Control and Prevention data, with fewer than 30,000 daily cases. At the same time, the rate of decline in cases has slowed significantly and is beginning to plateau.
Public health experts are also pointing to wastewater surveillance data that shows an uptick in viral activity across the country. The CDC’s wastewater dashboard indicates that about 35% of sites that monitor wastewater are seeing an increase, with consistent growth in Florida, Rhode Island, and West Virginia.
“The power of wastewater surveillance is that it’s an early warning system,” Amy Kirby, the program lead for the CDC’s National Wastewater Surveillance System, told NPR.
“We are seeing evidence of increases in some communities across the country,” she said. “What looked like noise at the beginning of the week is starting to look like a true signal here at the end of the week.”
The wastewater system doesn’t distinguish between Omicron and subvariants such as BA.2. However, other CDC data has found an increase in BA.2 cases in the United States, making up about a quarter of new COVID-19 cases.
The BA.2 variant has roughly doubled each week for the last month, which means it could become the dominant coronavirus strain in the United States in coming weeks, according to USA Today. Cases appear to be spreading more quickly in the Northeast and West, making up about 39% of cases in New York and New Jersey last week.
BA.2 also accounts for nearly 39% of cases across the Northeast, including Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont, USA Today reported. In the West, which includes Arizona, California and Nevada, the subvariant makes up about 28% of new cases. In the upper West, which includes Alaska, Oregon and Washington, about 26% of cases are BA.2.
The good news is that BA.2 “doesn’t seem to evade our vaccines or immunity any more than the prior Omicron [variant]. And it doesn’t seem to lead to any more increased severity of disease,” Rochelle Walensky, MD, the CDC director, told NPR’s Morning Edition on March 18.
The effects of BA.2 will likely depend on the immunity profile in the United States, including how long it’s been since someone was vaccinated, boosted, or recovered from an infection, she said.
Health officials are watching other countries with BA.2 increases, such as Germany, Italy, and the Netherlands. Many European countries have been reporting an uptick but not implementing major restrictions or shutdowns, USA Today reported.
The BA.2 variant likely won’t lead to a major surge in severe disease or strict COVID-19 measures, Dr. Fauci told NPR, but some coronavirus protocols may need to be implemented again if cases grow dramatically.
“We must be ready to pivot and, if necessary, to go back to stricter mitigation with regard to masks,” he said.
A version of this article first appeared on WebMD.com.
First-line CAR T-cell therapy could help cure some lymphomas
Results of the phase 2 ZUMA-12 trial suggest that axicabtagene ciloleucel (axi-cel), a chimeric antigen receptor (CAR) T-cell therapy approved to treat certain types of lymphoma, also shows promise as a treatment for another group of lymphoma patients – those with high-risk large B-cell lymphoma (LBCL) who failed two rounds of standard chemoimmunotherapy. In fact, a study author said, first-line treatment with this therapy could help usher some patients toward a cure.
The results appeared March 21, 2022, in Nature Medicine.
“The high efficacy with manageable safety profile suggest that further evaluation of axi-cel in first-line setting in patients with high-risk LBCL is warranted in a randomized, phase 3 trial comparing it to standard chemoimmunotherapy,” study lead author Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center, Houston, said in an interview.
According to Dr. Neelapu, “patients with high-risk LBCL include those with high-intermediate or high International Prognostic Index score and those with certain molecular subtypes such as double- or triple-hit lymphoma. These patients have lower response rates and lower progression-free and overall survival with standard chemoimmunotherapy.”
Treatment of these patients can be especially challenging because they are underrepresented in clinical research, hematologist Michael Dickinson, MBBS, of the Peter MacCallum Cancer Center in Melbourne, said in an interview. “They often have disease that requires urgent treatment, so there is no time to recruit them into trials. A feature of ZUMA-12 is that it allowed patients to be recruited after short exposure to chemotherapy, which means that higher-risk patients could successfully be recruited into the trial.”
Axi-cel is already Food and Drug Administration approved for treatment of relapsed or refractory LBCL after 2 or more lines of systemic therapy plus relapsed or refractory follicular lymphoma, also after two or more lines of systemic therapy, Dr. Neelapu said.
For this study, researchers administered the treatment to 40 subjects with high-risk disease from 2019-2020 (median age, 61 years; 68% male; 95% at disease stage III or IV).
The researchers reported that 78% of 37 patients in the primary efficacy analysis reached complete response rate (95% confidence interval, 62-90); the median time to first complete response rate was 30 days (range, 27-207). About 89% of these subjects reached the secondary endpoint of objective response rate (95% CI, 75-97); the median time to first objective response was 29 days (range, 27-207).
At a median follow-up of 15.9 months, 73% were still in objective response.
“This is quite remarkable,” Dr. Neelapu said. “The durability of more than 70% is far higher than what would be expected with standard chemoimmunotherapy in these patients – under 40% durability with standard chemoimmunotherapy. Also, axi-cel induces durable responses in about 40% of patients in second- and third-line setting. However, when used as part of first-line therapy in this study, durable responses were observed in more than 70% of patients, suggesting that the efficacy of axi-cel may be much higher when used in first-line setting.”
Dr. Neelapu added: “Although the follow-up is short, it is highly likely that the majority of the patients with ongoing response beyond 1 year will likely be cured of their lymphoma.”
As for side effects, no treatment-related grade 5 events occurred, but 18 patients (45%) experienced serious adverse events. Grade 3 or higher cytokine release syndrome occurred in three patients (8%) and nine experienced neurologic events (23%).
“The majority of the higher-grade adverse events observed were due to cytopenias, which were expected due to the conditioning therapy,” Dr. Neelapu said. “Such cytopenias would also have been expected if these patients had received standard chemoimmunotherapy.”
Six patients (15%) died, 4 of progressive disease after going forward to other therapies.
As for cost, Dr. Neelapu said it should be similar to that of axi-cel as an FDA-approved third-line therapy. Axi-cel is highly expensive. Research has suggested that CAR T-cell therapy can boost costs beyond standard chemotherapy by $350,000-$490,000 with gains of 2-8 years of life (J Med Econ. Jan-Dec 2021;24[1]:458-68).
The study was funded by Kite. The authors reported various disclosures.
Results of the phase 2 ZUMA-12 trial suggest that axicabtagene ciloleucel (axi-cel), a chimeric antigen receptor (CAR) T-cell therapy approved to treat certain types of lymphoma, also shows promise as a treatment for another group of lymphoma patients – those with high-risk large B-cell lymphoma (LBCL) who failed two rounds of standard chemoimmunotherapy. In fact, a study author said, first-line treatment with this therapy could help usher some patients toward a cure.
The results appeared March 21, 2022, in Nature Medicine.
“The high efficacy with manageable safety profile suggest that further evaluation of axi-cel in first-line setting in patients with high-risk LBCL is warranted in a randomized, phase 3 trial comparing it to standard chemoimmunotherapy,” study lead author Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center, Houston, said in an interview.
According to Dr. Neelapu, “patients with high-risk LBCL include those with high-intermediate or high International Prognostic Index score and those with certain molecular subtypes such as double- or triple-hit lymphoma. These patients have lower response rates and lower progression-free and overall survival with standard chemoimmunotherapy.”
Treatment of these patients can be especially challenging because they are underrepresented in clinical research, hematologist Michael Dickinson, MBBS, of the Peter MacCallum Cancer Center in Melbourne, said in an interview. “They often have disease that requires urgent treatment, so there is no time to recruit them into trials. A feature of ZUMA-12 is that it allowed patients to be recruited after short exposure to chemotherapy, which means that higher-risk patients could successfully be recruited into the trial.”
Axi-cel is already Food and Drug Administration approved for treatment of relapsed or refractory LBCL after 2 or more lines of systemic therapy plus relapsed or refractory follicular lymphoma, also after two or more lines of systemic therapy, Dr. Neelapu said.
For this study, researchers administered the treatment to 40 subjects with high-risk disease from 2019-2020 (median age, 61 years; 68% male; 95% at disease stage III or IV).
The researchers reported that 78% of 37 patients in the primary efficacy analysis reached complete response rate (95% confidence interval, 62-90); the median time to first complete response rate was 30 days (range, 27-207). About 89% of these subjects reached the secondary endpoint of objective response rate (95% CI, 75-97); the median time to first objective response was 29 days (range, 27-207).
At a median follow-up of 15.9 months, 73% were still in objective response.
“This is quite remarkable,” Dr. Neelapu said. “The durability of more than 70% is far higher than what would be expected with standard chemoimmunotherapy in these patients – under 40% durability with standard chemoimmunotherapy. Also, axi-cel induces durable responses in about 40% of patients in second- and third-line setting. However, when used as part of first-line therapy in this study, durable responses were observed in more than 70% of patients, suggesting that the efficacy of axi-cel may be much higher when used in first-line setting.”
Dr. Neelapu added: “Although the follow-up is short, it is highly likely that the majority of the patients with ongoing response beyond 1 year will likely be cured of their lymphoma.”
As for side effects, no treatment-related grade 5 events occurred, but 18 patients (45%) experienced serious adverse events. Grade 3 or higher cytokine release syndrome occurred in three patients (8%) and nine experienced neurologic events (23%).
“The majority of the higher-grade adverse events observed were due to cytopenias, which were expected due to the conditioning therapy,” Dr. Neelapu said. “Such cytopenias would also have been expected if these patients had received standard chemoimmunotherapy.”
Six patients (15%) died, 4 of progressive disease after going forward to other therapies.
As for cost, Dr. Neelapu said it should be similar to that of axi-cel as an FDA-approved third-line therapy. Axi-cel is highly expensive. Research has suggested that CAR T-cell therapy can boost costs beyond standard chemotherapy by $350,000-$490,000 with gains of 2-8 years of life (J Med Econ. Jan-Dec 2021;24[1]:458-68).
The study was funded by Kite. The authors reported various disclosures.
Results of the phase 2 ZUMA-12 trial suggest that axicabtagene ciloleucel (axi-cel), a chimeric antigen receptor (CAR) T-cell therapy approved to treat certain types of lymphoma, also shows promise as a treatment for another group of lymphoma patients – those with high-risk large B-cell lymphoma (LBCL) who failed two rounds of standard chemoimmunotherapy. In fact, a study author said, first-line treatment with this therapy could help usher some patients toward a cure.
The results appeared March 21, 2022, in Nature Medicine.
“The high efficacy with manageable safety profile suggest that further evaluation of axi-cel in first-line setting in patients with high-risk LBCL is warranted in a randomized, phase 3 trial comparing it to standard chemoimmunotherapy,” study lead author Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center, Houston, said in an interview.
According to Dr. Neelapu, “patients with high-risk LBCL include those with high-intermediate or high International Prognostic Index score and those with certain molecular subtypes such as double- or triple-hit lymphoma. These patients have lower response rates and lower progression-free and overall survival with standard chemoimmunotherapy.”
Treatment of these patients can be especially challenging because they are underrepresented in clinical research, hematologist Michael Dickinson, MBBS, of the Peter MacCallum Cancer Center in Melbourne, said in an interview. “They often have disease that requires urgent treatment, so there is no time to recruit them into trials. A feature of ZUMA-12 is that it allowed patients to be recruited after short exposure to chemotherapy, which means that higher-risk patients could successfully be recruited into the trial.”
Axi-cel is already Food and Drug Administration approved for treatment of relapsed or refractory LBCL after 2 or more lines of systemic therapy plus relapsed or refractory follicular lymphoma, also after two or more lines of systemic therapy, Dr. Neelapu said.
For this study, researchers administered the treatment to 40 subjects with high-risk disease from 2019-2020 (median age, 61 years; 68% male; 95% at disease stage III or IV).
The researchers reported that 78% of 37 patients in the primary efficacy analysis reached complete response rate (95% confidence interval, 62-90); the median time to first complete response rate was 30 days (range, 27-207). About 89% of these subjects reached the secondary endpoint of objective response rate (95% CI, 75-97); the median time to first objective response was 29 days (range, 27-207).
At a median follow-up of 15.9 months, 73% were still in objective response.
“This is quite remarkable,” Dr. Neelapu said. “The durability of more than 70% is far higher than what would be expected with standard chemoimmunotherapy in these patients – under 40% durability with standard chemoimmunotherapy. Also, axi-cel induces durable responses in about 40% of patients in second- and third-line setting. However, when used as part of first-line therapy in this study, durable responses were observed in more than 70% of patients, suggesting that the efficacy of axi-cel may be much higher when used in first-line setting.”
Dr. Neelapu added: “Although the follow-up is short, it is highly likely that the majority of the patients with ongoing response beyond 1 year will likely be cured of their lymphoma.”
As for side effects, no treatment-related grade 5 events occurred, but 18 patients (45%) experienced serious adverse events. Grade 3 or higher cytokine release syndrome occurred in three patients (8%) and nine experienced neurologic events (23%).
“The majority of the higher-grade adverse events observed were due to cytopenias, which were expected due to the conditioning therapy,” Dr. Neelapu said. “Such cytopenias would also have been expected if these patients had received standard chemoimmunotherapy.”
Six patients (15%) died, 4 of progressive disease after going forward to other therapies.
As for cost, Dr. Neelapu said it should be similar to that of axi-cel as an FDA-approved third-line therapy. Axi-cel is highly expensive. Research has suggested that CAR T-cell therapy can boost costs beyond standard chemotherapy by $350,000-$490,000 with gains of 2-8 years of life (J Med Econ. Jan-Dec 2021;24[1]:458-68).
The study was funded by Kite. The authors reported various disclosures.
FROM NATURE MEDICINE