Federal Practitioner

Few ever see this side of cancer care. Our cameras go behind the scenes as a surgical oncologist faces a crucial moment in the OR in this first episode of a new video series, The Oncologists.

Medscape Oncology © 2021 WebMD, LLC

Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.

Cite this: A Pivotal Moment in Cancer Surgery, Captured on Film - Medscape - Feb 18, 2021.

Few ever see this side of cancer care. Our cameras go behind the scenes as a surgical oncologist faces a crucial moment in the OR in this first episode of a new video series, The Oncologists.

Medscape Oncology © 2021 WebMD, LLC

Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.

Cite this: A Pivotal Moment in Cancer Surgery, Captured on Film - Medscape - Feb 18, 2021.

Few ever see this side of cancer care. Our cameras go behind the scenes as a surgical oncologist faces a crucial moment in the OR in this first episode of a new video series, The Oncologists.

Medscape Oncology © 2021 WebMD, LLC

Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.

Cite this: A Pivotal Moment in Cancer Surgery, Captured on Film - Medscape - Feb 18, 2021.

What started as an attempt to standardize care for acute myocardial infarction with cardiogenic shock at a handful of Detroit-area hospitals has led to markedly better survival rates than the traditional flip of a coin, in a nationwide analysis.

Final results from the National Cardiogenic Shock Initiative (NCSI) show 71% of patients survived to discharge and 68% were alive at 30 days.

Patients presenting in stage C or D shock, who comprised the bulk of patients in previous trials, had survival rates of 79% and 77%, respectively.

Among stage E patients, who are in extremis and have typical survival rates of less than 20%, survival was 54% at discharge and 49% at 30 days, co–principal investigator Babar Basir, DO, Henry Ford Hospital, Detroit, reported at the Society for Cardiovascular Angiography and Interventions (SCAI) annual scientific sessions, held virtually.

“This is the first push to really be able to consistently get survival rates over 50%, particularly in those patients who presented in stage C and D shock,” he said. “Really, it’s important to emphasize here the hard work it’s taken to get to this point and all the research that’s been done.”

The NCSI protocol emphasizes rapid identification and support of cardiogenic shock (door to support time <90 minutes), early placement of the Impella (Abiomed) ventricular assist device prior to percutaneous coronary intervention (PCI), and right heart monitoring to reduce the use of inotropes and vasopressors.

Co–principal investigator William O’Neill, MD, also from Henry Ford, previously reported results from the pilot study showing 84% of 30 patients survived to discharge.

The present analysis was based on outcomes of 406 consecutive acute MI patients (mean age, 63.7 years; 24% female) who presented with cardiogenic shock at 32 academic and 48 community hospitals in 29 states and the District of Columbia.

Dr. Basir emphasized that this is the largest prospective North American acute MI cardiogenic shock study in 20 years and recruited “one of the sickest cohorts ever studied.” The average blood pressure among the patients was 77/50 mm Hg; 77% had a lactate of at least 2 mmol/L (mean, 4.8 mmol/L), and 25% were in stage E shock.

One-quarter of patients were transferred from other institutions, 82% presented with ST-segment elevation MI, two-thirds had multivessel disease, and 13% had a left main culprit lesion.

Right heart catheterization was used in 90% of patients, an Impella CP device in 92%, an Impella 2.5 device in 5%, femoral access PCI in 78%, and aspiration thrombectomy in a full 27%.

Despite this sick cohort, survival at 30 days was better than in any previous study of cardiogenic shock, Dr. Basir said. In comparison, 30-day survival rates were 53%, 60%, and 49% in the SHOCK, IABP SHOCK, and CULPRIT SHOCK trials, respectively.

That said, survival over the course of the first year fell to 53% in the entire cohort, 62% in patients with stage C or D shock, and 31% in those in stage E shock.

“One-year mortality continues to be a problem for these patients and emphasizes the need for goal-directed medical therapy, early advanced heart failure follow-up, and novel therapies such as what we are planning with the evaluation of [supersaturated oxygen] SSO₂ to reduce infarct sizes in the ISO-SHOCK trial,” set to begin later this year, Dr. Basir said.

Given the promising results in the NCSI, the randomized controlled RECOVER IV trial is planned to begin in 2022, he noted. It will assess whether Impella pre-PCI is superior to PCI without Impella in patients with inclusion criteria similar to that of the NCSI. The DanGer Shock randomized trial is ongoing in Denmark and Germany and assessing all-cause mortality at 6 months with the Impella CP device compared with standard of care.

“We hypothesize that greater utilization of this protocol, and refinement of the escalation strategies will consistently lead to a survival rate greater than 80%,” Dr. Basir concluded.

Past SCAI president Kirk Garratt, MD, Christiana Care, Newark, Del., who moderated a press conference where the data were highlighted, noted that late complications led to a roughly 20% absolute mortality increase from discharge to 1 year, and questioned what percentage could be attributed to the mechanical support offered.

Dr. Basir said that information was not specifically tracked but that many patients presented with multiorgan failure and, irrespective of that, the majority died from ongoing heart failure.

During the formal presentation, panelist Ron Waksman, MD, MedStar Heart Institute, Washington, questioned whether results were different between academic and community centers, but also pointed to the lack of a comparator in the single-arm study.

“It’s very hard to do any comparison historically; we do need to have a control group,” he said. “If you would have opened it to any treatment at the time of the initiative, which is great, but not just limit it to use of the Impella devices, we would have better understanding if there is really a differentiation between one device versus the other devices.”

Dr. Basir replied, “I think that is a very reasonable comment and, in regard to your question, it is always difficult to differentiate between academic and community centers, but these were large community programs that have all of the technologies available in an academic center.”

NCIS is funded in part by unrestricted grants from Abiomed and Chiesi. Dr. Basir reported consulting for Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Procyrion, and Zoll.

A version of this article first appeared on Medscape.com.

What started as an attempt to standardize care for acute myocardial infarction with cardiogenic shock at a handful of Detroit-area hospitals has led to markedly better survival rates than the traditional flip of a coin, in a nationwide analysis.

Final results from the National Cardiogenic Shock Initiative (NCSI) show 71% of patients survived to discharge and 68% were alive at 30 days.

Patients presenting in stage C or D shock, who comprised the bulk of patients in previous trials, had survival rates of 79% and 77%, respectively.

Among stage E patients, who are in extremis and have typical survival rates of less than 20%, survival was 54% at discharge and 49% at 30 days, co–principal investigator Babar Basir, DO, Henry Ford Hospital, Detroit, reported at the Society for Cardiovascular Angiography and Interventions (SCAI) annual scientific sessions, held virtually.

“This is the first push to really be able to consistently get survival rates over 50%, particularly in those patients who presented in stage C and D shock,” he said. “Really, it’s important to emphasize here the hard work it’s taken to get to this point and all the research that’s been done.”

The NCSI protocol emphasizes rapid identification and support of cardiogenic shock (door to support time <90 minutes), early placement of the Impella (Abiomed) ventricular assist device prior to percutaneous coronary intervention (PCI), and right heart monitoring to reduce the use of inotropes and vasopressors.

Co–principal investigator William O’Neill, MD, also from Henry Ford, previously reported results from the pilot study showing 84% of 30 patients survived to discharge.

The present analysis was based on outcomes of 406 consecutive acute MI patients (mean age, 63.7 years; 24% female) who presented with cardiogenic shock at 32 academic and 48 community hospitals in 29 states and the District of Columbia.

Dr. Basir emphasized that this is the largest prospective North American acute MI cardiogenic shock study in 20 years and recruited “one of the sickest cohorts ever studied.” The average blood pressure among the patients was 77/50 mm Hg; 77% had a lactate of at least 2 mmol/L (mean, 4.8 mmol/L), and 25% were in stage E shock.

One-quarter of patients were transferred from other institutions, 82% presented with ST-segment elevation MI, two-thirds had multivessel disease, and 13% had a left main culprit lesion.

Right heart catheterization was used in 90% of patients, an Impella CP device in 92%, an Impella 2.5 device in 5%, femoral access PCI in 78%, and aspiration thrombectomy in a full 27%.

Despite this sick cohort, survival at 30 days was better than in any previous study of cardiogenic shock, Dr. Basir said. In comparison, 30-day survival rates were 53%, 60%, and 49% in the SHOCK, IABP SHOCK, and CULPRIT SHOCK trials, respectively.

That said, survival over the course of the first year fell to 53% in the entire cohort, 62% in patients with stage C or D shock, and 31% in those in stage E shock.

“One-year mortality continues to be a problem for these patients and emphasizes the need for goal-directed medical therapy, early advanced heart failure follow-up, and novel therapies such as what we are planning with the evaluation of [supersaturated oxygen] SSO₂ to reduce infarct sizes in the ISO-SHOCK trial,” set to begin later this year, Dr. Basir said.

Given the promising results in the NCSI, the randomized controlled RECOVER IV trial is planned to begin in 2022, he noted. It will assess whether Impella pre-PCI is superior to PCI without Impella in patients with inclusion criteria similar to that of the NCSI. The DanGer Shock randomized trial is ongoing in Denmark and Germany and assessing all-cause mortality at 6 months with the Impella CP device compared with standard of care.

“We hypothesize that greater utilization of this protocol, and refinement of the escalation strategies will consistently lead to a survival rate greater than 80%,” Dr. Basir concluded.

Past SCAI president Kirk Garratt, MD, Christiana Care, Newark, Del., who moderated a press conference where the data were highlighted, noted that late complications led to a roughly 20% absolute mortality increase from discharge to 1 year, and questioned what percentage could be attributed to the mechanical support offered.

Dr. Basir said that information was not specifically tracked but that many patients presented with multiorgan failure and, irrespective of that, the majority died from ongoing heart failure.

During the formal presentation, panelist Ron Waksman, MD, MedStar Heart Institute, Washington, questioned whether results were different between academic and community centers, but also pointed to the lack of a comparator in the single-arm study.

“It’s very hard to do any comparison historically; we do need to have a control group,” he said. “If you would have opened it to any treatment at the time of the initiative, which is great, but not just limit it to use of the Impella devices, we would have better understanding if there is really a differentiation between one device versus the other devices.”

Dr. Basir replied, “I think that is a very reasonable comment and, in regard to your question, it is always difficult to differentiate between academic and community centers, but these were large community programs that have all of the technologies available in an academic center.”

NCIS is funded in part by unrestricted grants from Abiomed and Chiesi. Dr. Basir reported consulting for Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Procyrion, and Zoll.

A version of this article first appeared on Medscape.com.

What started as an attempt to standardize care for acute myocardial infarction with cardiogenic shock at a handful of Detroit-area hospitals has led to markedly better survival rates than the traditional flip of a coin, in a nationwide analysis.

Final results from the National Cardiogenic Shock Initiative (NCSI) show 71% of patients survived to discharge and 68% were alive at 30 days.

Patients presenting in stage C or D shock, who comprised the bulk of patients in previous trials, had survival rates of 79% and 77%, respectively.

Among stage E patients, who are in extremis and have typical survival rates of less than 20%, survival was 54% at discharge and 49% at 30 days, co–principal investigator Babar Basir, DO, Henry Ford Hospital, Detroit, reported at the Society for Cardiovascular Angiography and Interventions (SCAI) annual scientific sessions, held virtually.

“This is the first push to really be able to consistently get survival rates over 50%, particularly in those patients who presented in stage C and D shock,” he said. “Really, it’s important to emphasize here the hard work it’s taken to get to this point and all the research that’s been done.”

The NCSI protocol emphasizes rapid identification and support of cardiogenic shock (door to support time <90 minutes), early placement of the Impella (Abiomed) ventricular assist device prior to percutaneous coronary intervention (PCI), and right heart monitoring to reduce the use of inotropes and vasopressors.

Co–principal investigator William O’Neill, MD, also from Henry Ford, previously reported results from the pilot study showing 84% of 30 patients survived to discharge.

The present analysis was based on outcomes of 406 consecutive acute MI patients (mean age, 63.7 years; 24% female) who presented with cardiogenic shock at 32 academic and 48 community hospitals in 29 states and the District of Columbia.

Dr. Basir emphasized that this is the largest prospective North American acute MI cardiogenic shock study in 20 years and recruited “one of the sickest cohorts ever studied.” The average blood pressure among the patients was 77/50 mm Hg; 77% had a lactate of at least 2 mmol/L (mean, 4.8 mmol/L), and 25% were in stage E shock.

One-quarter of patients were transferred from other institutions, 82% presented with ST-segment elevation MI, two-thirds had multivessel disease, and 13% had a left main culprit lesion.

Right heart catheterization was used in 90% of patients, an Impella CP device in 92%, an Impella 2.5 device in 5%, femoral access PCI in 78%, and aspiration thrombectomy in a full 27%.

Despite this sick cohort, survival at 30 days was better than in any previous study of cardiogenic shock, Dr. Basir said. In comparison, 30-day survival rates were 53%, 60%, and 49% in the SHOCK, IABP SHOCK, and CULPRIT SHOCK trials, respectively.

That said, survival over the course of the first year fell to 53% in the entire cohort, 62% in patients with stage C or D shock, and 31% in those in stage E shock.

“One-year mortality continues to be a problem for these patients and emphasizes the need for goal-directed medical therapy, early advanced heart failure follow-up, and novel therapies such as what we are planning with the evaluation of [supersaturated oxygen] SSO₂ to reduce infarct sizes in the ISO-SHOCK trial,” set to begin later this year, Dr. Basir said.

Given the promising results in the NCSI, the randomized controlled RECOVER IV trial is planned to begin in 2022, he noted. It will assess whether Impella pre-PCI is superior to PCI without Impella in patients with inclusion criteria similar to that of the NCSI. The DanGer Shock randomized trial is ongoing in Denmark and Germany and assessing all-cause mortality at 6 months with the Impella CP device compared with standard of care.

“We hypothesize that greater utilization of this protocol, and refinement of the escalation strategies will consistently lead to a survival rate greater than 80%,” Dr. Basir concluded.

Past SCAI president Kirk Garratt, MD, Christiana Care, Newark, Del., who moderated a press conference where the data were highlighted, noted that late complications led to a roughly 20% absolute mortality increase from discharge to 1 year, and questioned what percentage could be attributed to the mechanical support offered.

Dr. Basir said that information was not specifically tracked but that many patients presented with multiorgan failure and, irrespective of that, the majority died from ongoing heart failure.

During the formal presentation, panelist Ron Waksman, MD, MedStar Heart Institute, Washington, questioned whether results were different between academic and community centers, but also pointed to the lack of a comparator in the single-arm study.

“It’s very hard to do any comparison historically; we do need to have a control group,” he said. “If you would have opened it to any treatment at the time of the initiative, which is great, but not just limit it to use of the Impella devices, we would have better understanding if there is really a differentiation between one device versus the other devices.”

Dr. Basir replied, “I think that is a very reasonable comment and, in regard to your question, it is always difficult to differentiate between academic and community centers, but these were large community programs that have all of the technologies available in an academic center.”

NCIS is funded in part by unrestricted grants from Abiomed and Chiesi. Dr. Basir reported consulting for Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Procyrion, and Zoll.

A version of this article first appeared on Medscape.com.

Although vaccination rates against the human papillomavirus remain low for young adults across the United States, the number of self-reported HPV vaccinations among women and men aged between 18 and 21 years has markedly increased since 2010, according to new research findings.

The findings were published online April 27, 2021, as a research letter in JAMA.

In 2006, the Food and Drug Administration approved the HPV vaccine for the prevention of cervical cancer and genital warts in female patients. Three years later, the FDA approved the vaccine for the prevention of anogenital cancer and warts in male patients.

The Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention recommend two doses of the HPV vaccine for children aged 11-12 years. Adolescents and young adults may need three doses over the course of 6 months if they start their vaccine series on or following their 15th birthday.

For persons who have not previously received the HPV vaccine or who did not receive adequate doses, the HPV vaccine is recommended through age 26. Data on the rates of vaccination among young adults between 18 and 21 years of age in the United States are sparse, and it is not known how well vaccination programs are progressing in the country.

In the recently published JAMA research letter, investigators from the University of Michigan, Ann Arbor, examined data for the period 2010-2018 from the cross-sectional National Health Interview Survey. Respondents included in the analysis were aged 18-21 years. They were asked whether they had received the HPV vaccine before age 18 and at what age they had been vaccinated against the virus.

The researchers also assessed whether the respondents had received any HPV vaccine dose between the ages of 18 and 21 years. The findings were limited to self-reported vaccination status.

In total, 6,606 women and 6,038 men were included in the analysis. Approximately 42% of women and 16% of men said they had received at least one HPV vaccine dose at any age. The proportion of female patients who reported receiving an HPV vaccine dose significantly increased from 32% in 2010 to 55% in 2018 (P =.001). Similarly, among men, the percentage significantly increased from 2% in 2010 to 34% in 2018 (P <.001).

Approximately 4% of the female respondents and 3% of the male respondents reported that they had received an HPV vaccine between the ages of 18 and 21 years; 46% of women and 29% of men who received the vaccine between these ages completed the recommended vaccination series.

Findings from the study highlight the continual need for improving vaccination rates among vulnerable populations. Lead study author Michelle Chen, MD, MHS, a professor in the department of otolaryngology–head and neck surgery at the University of Michigan, explained in an interview that there are multiple barriers to HPV vaccination among young adults. “These barriers to vaccination among young adults primarily include cost, lack of knowledge and awareness, missed opportunities for vaccination, rapidly changing guidelines, and initial gender-based guidelines,” said Dr. Chen.

Clinicians play a large role in improving vaccination rates among young adults, who may lack awareness of the overall importance of inoculation against the potentially debilitating and deadly virus. Dr. Chen noted that clinicians can lead the way by increasing gender-inclusive awareness of HPV-associated diseases and HPV vaccination, by performing routine vaccine eligibility assessments for young adults regardless of sex, by developing robust reminder and recall strategies to improve series completion rates, and by offering patients resources regarding assistance programs to address cost barriers for uninsured patients.

“Young adult men are particularly vulnerable [to HPV], because they start to age out of pediatric health practices,” added Dr. Chen. “Thus, a multilevel gender-inclusive approach is needed to target clinicians, patients, parents, and community-based organizations.”

Gypsyamber D’Souza, PhD, professor of epidemiology at Johns Hopkins University, Baltimore, said in an interview that the initial uptake of HPV vaccination was slow in the United States but that progress has been made in recent years among persons in the targeted age range of 11-12 years. “However, catch-up vaccination has lagged behind, and sadly, we’re still seeing low uptake in those older ages that are still eligible and where we know there still is tremendous benefit,” she said.

Dr. D’Souza is a lead investigator in the MOUTH trial, which is currently enrolling patients. That trial will examine potential biomarkers for oropharyngeal cancer risk among people with known risk factors for HPV who came of age prior to the rollout of the vaccine.

She explained that many parents want their children to be vaccinated for HPV after they hear about the vaccine, but because the health care system in the United States is an “opt-in” system, rather than an “opt-out” one, parents need to actively seek out vaccination. Children then move toward adulthood without having received the recommended vaccine course. “There are individuals who did not get vaccinated at the ages of 11 and 12 and then forget to ask about it later, or the provider asks about it and the patients don’t have enough information,” Dr. D’Souza said.

She noted that one reason why HPV vaccination rates remain low among young adults is that the vaccine is not often kept in stock other than in pediatric clinics. “Because vaccines expire and clinics don’t have a lot of people in that age group getting vaccinated, they may not have it regularly in stock, making this one reason it might be hard for someone to get vaccinated.”

The HPV vaccine is not effective for clearing HPV once a patient acquires the infection, she added. “So young adulthood is a critical time where we have individuals who still can benefit from being vaccinated, but if we wait too long, they’ll age out of those ages where we see the highest efficacy.”

Ultimately, said Dr. D’Souza, clinicians need to catch people at multiple time points and work to remove barriers to vaccination, including letting patients know that HPV vaccination is covered by insurance. “There’s a lot of opportunity to prevent future cancers in young adults by having care providers for that age group talk about the vaccine and remember to offer it.”

A version of this article first appeared on Medscape.com.

Although vaccination rates against the human papillomavirus remain low for young adults across the United States, the number of self-reported HPV vaccinations among women and men aged between 18 and 21 years has markedly increased since 2010, according to new research findings.

The findings were published online April 27, 2021, as a research letter in JAMA.

In 2006, the Food and Drug Administration approved the HPV vaccine for the prevention of cervical cancer and genital warts in female patients. Three years later, the FDA approved the vaccine for the prevention of anogenital cancer and warts in male patients.

The Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention recommend two doses of the HPV vaccine for children aged 11-12 years. Adolescents and young adults may need three doses over the course of 6 months if they start their vaccine series on or following their 15th birthday.

For persons who have not previously received the HPV vaccine or who did not receive adequate doses, the HPV vaccine is recommended through age 26. Data on the rates of vaccination among young adults between 18 and 21 years of age in the United States are sparse, and it is not known how well vaccination programs are progressing in the country.

In the recently published JAMA research letter, investigators from the University of Michigan, Ann Arbor, examined data for the period 2010-2018 from the cross-sectional National Health Interview Survey. Respondents included in the analysis were aged 18-21 years. They were asked whether they had received the HPV vaccine before age 18 and at what age they had been vaccinated against the virus.

The researchers also assessed whether the respondents had received any HPV vaccine dose between the ages of 18 and 21 years. The findings were limited to self-reported vaccination status.

In total, 6,606 women and 6,038 men were included in the analysis. Approximately 42% of women and 16% of men said they had received at least one HPV vaccine dose at any age. The proportion of female patients who reported receiving an HPV vaccine dose significantly increased from 32% in 2010 to 55% in 2018 (P =.001). Similarly, among men, the percentage significantly increased from 2% in 2010 to 34% in 2018 (P <.001).

Approximately 4% of the female respondents and 3% of the male respondents reported that they had received an HPV vaccine between the ages of 18 and 21 years; 46% of women and 29% of men who received the vaccine between these ages completed the recommended vaccination series.

Findings from the study highlight the continual need for improving vaccination rates among vulnerable populations. Lead study author Michelle Chen, MD, MHS, a professor in the department of otolaryngology–head and neck surgery at the University of Michigan, explained in an interview that there are multiple barriers to HPV vaccination among young adults. “These barriers to vaccination among young adults primarily include cost, lack of knowledge and awareness, missed opportunities for vaccination, rapidly changing guidelines, and initial gender-based guidelines,” said Dr. Chen.

Clinicians play a large role in improving vaccination rates among young adults, who may lack awareness of the overall importance of inoculation against the potentially debilitating and deadly virus. Dr. Chen noted that clinicians can lead the way by increasing gender-inclusive awareness of HPV-associated diseases and HPV vaccination, by performing routine vaccine eligibility assessments for young adults regardless of sex, by developing robust reminder and recall strategies to improve series completion rates, and by offering patients resources regarding assistance programs to address cost barriers for uninsured patients.

“Young adult men are particularly vulnerable [to HPV], because they start to age out of pediatric health practices,” added Dr. Chen. “Thus, a multilevel gender-inclusive approach is needed to target clinicians, patients, parents, and community-based organizations.”

Gypsyamber D’Souza, PhD, professor of epidemiology at Johns Hopkins University, Baltimore, said in an interview that the initial uptake of HPV vaccination was slow in the United States but that progress has been made in recent years among persons in the targeted age range of 11-12 years. “However, catch-up vaccination has lagged behind, and sadly, we’re still seeing low uptake in those older ages that are still eligible and where we know there still is tremendous benefit,” she said.

Dr. D’Souza is a lead investigator in the MOUTH trial, which is currently enrolling patients. That trial will examine potential biomarkers for oropharyngeal cancer risk among people with known risk factors for HPV who came of age prior to the rollout of the vaccine.

She explained that many parents want their children to be vaccinated for HPV after they hear about the vaccine, but because the health care system in the United States is an “opt-in” system, rather than an “opt-out” one, parents need to actively seek out vaccination. Children then move toward adulthood without having received the recommended vaccine course. “There are individuals who did not get vaccinated at the ages of 11 and 12 and then forget to ask about it later, or the provider asks about it and the patients don’t have enough information,” Dr. D’Souza said.

She noted that one reason why HPV vaccination rates remain low among young adults is that the vaccine is not often kept in stock other than in pediatric clinics. “Because vaccines expire and clinics don’t have a lot of people in that age group getting vaccinated, they may not have it regularly in stock, making this one reason it might be hard for someone to get vaccinated.”

The HPV vaccine is not effective for clearing HPV once a patient acquires the infection, she added. “So young adulthood is a critical time where we have individuals who still can benefit from being vaccinated, but if we wait too long, they’ll age out of those ages where we see the highest efficacy.”

Ultimately, said Dr. D’Souza, clinicians need to catch people at multiple time points and work to remove barriers to vaccination, including letting patients know that HPV vaccination is covered by insurance. “There’s a lot of opportunity to prevent future cancers in young adults by having care providers for that age group talk about the vaccine and remember to offer it.”

A version of this article first appeared on Medscape.com.

Although vaccination rates against the human papillomavirus remain low for young adults across the United States, the number of self-reported HPV vaccinations among women and men aged between 18 and 21 years has markedly increased since 2010, according to new research findings.

The findings were published online April 27, 2021, as a research letter in JAMA.

In 2006, the Food and Drug Administration approved the HPV vaccine for the prevention of cervical cancer and genital warts in female patients. Three years later, the FDA approved the vaccine for the prevention of anogenital cancer and warts in male patients.

The Advisory Committee on Immunization Practices and the Centers for Disease Control and Prevention recommend two doses of the HPV vaccine for children aged 11-12 years. Adolescents and young adults may need three doses over the course of 6 months if they start their vaccine series on or following their 15th birthday.

For persons who have not previously received the HPV vaccine or who did not receive adequate doses, the HPV vaccine is recommended through age 26. Data on the rates of vaccination among young adults between 18 and 21 years of age in the United States are sparse, and it is not known how well vaccination programs are progressing in the country.

In the recently published JAMA research letter, investigators from the University of Michigan, Ann Arbor, examined data for the period 2010-2018 from the cross-sectional National Health Interview Survey. Respondents included in the analysis were aged 18-21 years. They were asked whether they had received the HPV vaccine before age 18 and at what age they had been vaccinated against the virus.

The researchers also assessed whether the respondents had received any HPV vaccine dose between the ages of 18 and 21 years. The findings were limited to self-reported vaccination status.

In total, 6,606 women and 6,038 men were included in the analysis. Approximately 42% of women and 16% of men said they had received at least one HPV vaccine dose at any age. The proportion of female patients who reported receiving an HPV vaccine dose significantly increased from 32% in 2010 to 55% in 2018 (P =.001). Similarly, among men, the percentage significantly increased from 2% in 2010 to 34% in 2018 (P <.001).

Approximately 4% of the female respondents and 3% of the male respondents reported that they had received an HPV vaccine between the ages of 18 and 21 years; 46% of women and 29% of men who received the vaccine between these ages completed the recommended vaccination series.

Findings from the study highlight the continual need for improving vaccination rates among vulnerable populations. Lead study author Michelle Chen, MD, MHS, a professor in the department of otolaryngology–head and neck surgery at the University of Michigan, explained in an interview that there are multiple barriers to HPV vaccination among young adults. “These barriers to vaccination among young adults primarily include cost, lack of knowledge and awareness, missed opportunities for vaccination, rapidly changing guidelines, and initial gender-based guidelines,” said Dr. Chen.

Clinicians play a large role in improving vaccination rates among young adults, who may lack awareness of the overall importance of inoculation against the potentially debilitating and deadly virus. Dr. Chen noted that clinicians can lead the way by increasing gender-inclusive awareness of HPV-associated diseases and HPV vaccination, by performing routine vaccine eligibility assessments for young adults regardless of sex, by developing robust reminder and recall strategies to improve series completion rates, and by offering patients resources regarding assistance programs to address cost barriers for uninsured patients.

“Young adult men are particularly vulnerable [to HPV], because they start to age out of pediatric health practices,” added Dr. Chen. “Thus, a multilevel gender-inclusive approach is needed to target clinicians, patients, parents, and community-based organizations.”

Gypsyamber D’Souza, PhD, professor of epidemiology at Johns Hopkins University, Baltimore, said in an interview that the initial uptake of HPV vaccination was slow in the United States but that progress has been made in recent years among persons in the targeted age range of 11-12 years. “However, catch-up vaccination has lagged behind, and sadly, we’re still seeing low uptake in those older ages that are still eligible and where we know there still is tremendous benefit,” she said.

Dr. D’Souza is a lead investigator in the MOUTH trial, which is currently enrolling patients. That trial will examine potential biomarkers for oropharyngeal cancer risk among people with known risk factors for HPV who came of age prior to the rollout of the vaccine.

She explained that many parents want their children to be vaccinated for HPV after they hear about the vaccine, but because the health care system in the United States is an “opt-in” system, rather than an “opt-out” one, parents need to actively seek out vaccination. Children then move toward adulthood without having received the recommended vaccine course. “There are individuals who did not get vaccinated at the ages of 11 and 12 and then forget to ask about it later, or the provider asks about it and the patients don’t have enough information,” Dr. D’Souza said.

She noted that one reason why HPV vaccination rates remain low among young adults is that the vaccine is not often kept in stock other than in pediatric clinics. “Because vaccines expire and clinics don’t have a lot of people in that age group getting vaccinated, they may not have it regularly in stock, making this one reason it might be hard for someone to get vaccinated.”

The HPV vaccine is not effective for clearing HPV once a patient acquires the infection, she added. “So young adulthood is a critical time where we have individuals who still can benefit from being vaccinated, but if we wait too long, they’ll age out of those ages where we see the highest efficacy.”

Ultimately, said Dr. D’Souza, clinicians need to catch people at multiple time points and work to remove barriers to vaccination, including letting patients know that HPV vaccination is covered by insurance. “There’s a lot of opportunity to prevent future cancers in young adults by having care providers for that age group talk about the vaccine and remember to offer it.”

A version of this article first appeared on Medscape.com.

Some, perhaps many, previously unrecognized cases of atrial fibrillation (AF) will come to light in a screening program aimed at older asymptomatic adults. The key question is whether the challenges of such systematic but age-restricted AF screening in the community, with oral anticoagulation (OAC) offered to those found to have the arrhythmia, is worthwhile in preventing events such as death or stroke.
 

Now there is evidence supporting such a clinical benefit from a large, prospective, randomized trial. A screening program restricted to people 75 or 76 years of age in two Swedish communities, which called on them to use a handheld single-lead ECG system at home intermittently for 2 weeks, was followed by a slight drop in clinical events over about 7 years.

The 4% decline in risk (P = .045) in the STROKESTOP trial’s “intention-to-treat” (ITT) analysis yielded a number needed to treat of 91; that is, that many people had to be targeted by the screening program to prevent one primary-endpoint clinical event.

Those included ischemic stroke, systemic thromboembolism, hospitalization for severe bleeding, and death from any cause, investigators reported April 23 during the virtual European Heart Rhythm Association (EHRA) 2021 Congress.

If that benefit and its significance seem marginal, some secondary findings might be reassuring. Half the population of the target age in the two communities – 13,979 randomly selected people – were invited to join the trial and follow the screening protocol, comprising the ITT cohort. The other half, numbering 13,996, was not invited and served as control subjects.

However, only 51% of the ITT cohort accepted the invitation and participated in the trial; they represented the “as-treated” cohort, observed Emma Svennberg, MD, PhD, Karolinska Institute, Danderyd Hospital, Stockholm, who presented the analysis at the EHRA sessions.

The screening protocol identified untreated AF, whether previously known or unknown, in about 5% of the 7,165 as-treated screening participants; OAC was initiated in about three-fourths of those cases.

The as-treated group, on their own, benefited with a 24% drop in the prospectively defined secondary endpoint of ischemic stroke, compared with the entire control group.

The clinical benefit in the ITT population was “small but significant,” but over the same period in the as-treated cohort, there was a highly significant drop in risk for ischemic stroke, Dr. Svennberg said in an interview.

The trial’s lead message, she said, is that “screening for atrial fibrillation in an elderly population reduces the risk of death and ischemic stroke without increasing the risk of bleeding.”
 

Caveats: As-treated vs. ITT

But there are caveats that complicate interpretation of the trial and, Dr. Svennberg proposed, point to the importance of that interpretation of both the ITT and as-treated analyses.

“We detected significantly more atrial fibrillation in the group that was randomized to screening. A major strength of our study was that we referred all of those individuals for a structured follow-up within the study,” she said. “Although the focus of the follow-up was oral anticoagulant therapy, other risk factors were also assessed and managed, such as hypertension and diabetes.”

It’s possible that increased detection of AF followed by such structured management contributed to the observed benefit, Dr. Svennberg proposed.

However, the exclusion of those in the prespecified ITT population who declined to be screened or otherwise didn’t participate left an as-treated cohort that was healthier than the ITT population or the control group.

Indeed, the nonparticipating invitees were sicker, with significantly more diabetes, vascular disease, hypertension, and heart failure, and higher CHA2DS2VASc stroke risk scores than those who agreed to participate.

“We took a more difficult route in setting up this study, in that we identified all individuals aged 75 to 76 residing in our two regions and excluded no one,” Dr. Svennberg said in an interview. “That means even individuals with end-stage disease, severe dementia, bedridden in nursing homes, et cetera, were also randomized but perhaps not likely or eligible to participate.”

Therefore, some invitees were unable to join the study even as others might have declined “out of low interest” or other personal reasons, she said. “We believe that this mimics how a population-based screening program would be performed if done in our country.”

In the ITT analysis, screening successfully identified previously unknown or untreated cases of AF, which led to expanded OAC use and intensified risk-factor management, “which was key to a successful outcome.”

In the as-treated analysis, Dr. Svennberg said, “I think a combination of the intervention and the population being overall more healthy was driving the secondary endpoint.”
 

Systematic vs. opportunistic screening

Although “opportunistic screening in individuals aged 65 and older” is recommended by current European Society of Cardiology guidelines, systematic screening, such as that used in STROKESTOP, has a much weaker evidence base, observed Renate B. Schnabel, MD, PhD, University Heart & Vascular Center, Hamburg, Germany, as the invited discussant after the STROKESTOP presentation.

STROKESTOP “is one of the first studies, if not the first study,” to show a clinical benefit from screening for AF, Dr. Schnabel said.

Fewer-than-projected primary outcome events were seen during the trial, and event curves for screened and control participants didn’t start to separate until about 4 years into the study, she said. It therefore might take a long time for the screened elderly to realize the clinical benefits of screening.

Studies such as the recent SCREEN-AF and mSTOPS have amply shown that AF screening in the asymptomatic elderly can reveal previously unrecognized AF far more often than would be detected in routine practice, allowing them the opportunity to go on OAC. But the trials weren’t able to show whether the benefits of such management outweigh the risks or costs.

Indeed, on April 20, the U.S. Preventive Services Task Force (USPSTF) released a draft recommendation statement concluding that “the current evidence is insufficient to assess the balance of benefits and harms” associated with AF screening in asymptomatic people at least 50 years of age.

In STROKESTOP, however, benefit for the primary outcome reached significance in the prespecified ITT analysis and “appeared to be driven by the reduction in ischemic stroke incidence,” Dr. Schnabel said.

“The future guidelines have gained strong evidence to judge on systematic atrial fibrillation screening” as it was performed in the trial, she said. “How to implement atrial fibrillation screening, including systematic screening in health care systems across Europe and beyond, remains an open question.”
 

A randomized population

STROKESTOP considered all 75- and 76-year-olds living in Sweden’s Stockholm County (n = 23,888) and the Halland region (n = 4,880) and randomly assigned them to the ITT group or a control group, with stratification by sex, birth year, and geographic region. In both groups, 54.6% were female and the mean CHA2DS2VASc score was 3.5.

People assigned to the ITT cohort were invited to be screened and followed. Those who agreed to participate underwent a baseline ECG assessment to detect or rule out permanent AF. Guideline-based OAC and follow-up was offered to those found with the arrhythmia. Those in sinus rhythm with no history of AF used a handheld single-lead ECG recorder (Zenicor) for 30 seconds twice daily for 14 days.

Structured management, including OAC, was offered to anyone demonstrating sufficient AF, that is, at least one bout without p waves in one 30-second recording or at least two such episodes lasting 10-29 seconds during the 2-week screening period.

In the ITT analysis, the hazard ratio (HR) for the composite clinical primary endpoint was 0.96 (95% confidence interval, 0.920-0.999; P = .045), but in the as-treated analysis, the HR for ischemic stroke was 0.76 (95% CI, 0.68-0.87; P < .001).

“I believe that this will likely be generalizable to most countries’ elderly residents,” Dr. Svennberg said. “I think if we can find a significant difference in our elderly population in Sweden, most countries will be able to do so, or find even more significant results.”

That’s because “baseline detection of AF in Sweden is high,” she said, “so new detection is likely more difficult.” Also, in Sweden, “care can be sought without monetary concern, and prescriptions are provided at low costs to the patients.” Therefore, patients newly identified with AF, whether in studies or not, “would likely be started on therapy.”

It will be important to know whether the screening strategy is cost-effective, Dr. Schnabel said, because “the overall effect, with a hazard ratio of 0.96, is not too big, and costs incurred by systematic screening are comparatively high.”

STROKESTOP “now provides sound information for cost-effectiveness analyses, which to date have largely relied on assumptions.”

STROKESTOP was partially supported by Carl Bennet AB, Boehringer-Ingelheim, Bayer, Bristol-Meyers Squibb, and Pfizer. Dr. Svennberg disclosed receiving fees for lectures or consulting from Bayer, Bristol-Meyers Squibb, Pfizer, Boehringer-Ingelheim, Merck Sharp & Dohme, and Sanofi; and institutional grants from Roche Diagnostics and Carl Bennett Ltd.

A version of this article first appeared on Medscape.com.

Some, perhaps many, previously unrecognized cases of atrial fibrillation (AF) will come to light in a screening program aimed at older asymptomatic adults. The key question is whether the challenges of such systematic but age-restricted AF screening in the community, with oral anticoagulation (OAC) offered to those found to have the arrhythmia, is worthwhile in preventing events such as death or stroke.
 

Now there is evidence supporting such a clinical benefit from a large, prospective, randomized trial. A screening program restricted to people 75 or 76 years of age in two Swedish communities, which called on them to use a handheld single-lead ECG system at home intermittently for 2 weeks, was followed by a slight drop in clinical events over about 7 years.

The 4% decline in risk (P = .045) in the STROKESTOP trial’s “intention-to-treat” (ITT) analysis yielded a number needed to treat of 91; that is, that many people had to be targeted by the screening program to prevent one primary-endpoint clinical event.

Those included ischemic stroke, systemic thromboembolism, hospitalization for severe bleeding, and death from any cause, investigators reported April 23 during the virtual European Heart Rhythm Association (EHRA) 2021 Congress.

If that benefit and its significance seem marginal, some secondary findings might be reassuring. Half the population of the target age in the two communities – 13,979 randomly selected people – were invited to join the trial and follow the screening protocol, comprising the ITT cohort. The other half, numbering 13,996, was not invited and served as control subjects.

However, only 51% of the ITT cohort accepted the invitation and participated in the trial; they represented the “as-treated” cohort, observed Emma Svennberg, MD, PhD, Karolinska Institute, Danderyd Hospital, Stockholm, who presented the analysis at the EHRA sessions.

The screening protocol identified untreated AF, whether previously known or unknown, in about 5% of the 7,165 as-treated screening participants; OAC was initiated in about three-fourths of those cases.

The as-treated group, on their own, benefited with a 24% drop in the prospectively defined secondary endpoint of ischemic stroke, compared with the entire control group.

The clinical benefit in the ITT population was “small but significant,” but over the same period in the as-treated cohort, there was a highly significant drop in risk for ischemic stroke, Dr. Svennberg said in an interview.

The trial’s lead message, she said, is that “screening for atrial fibrillation in an elderly population reduces the risk of death and ischemic stroke without increasing the risk of bleeding.”
 

Caveats: As-treated vs. ITT

But there are caveats that complicate interpretation of the trial and, Dr. Svennberg proposed, point to the importance of that interpretation of both the ITT and as-treated analyses.

“We detected significantly more atrial fibrillation in the group that was randomized to screening. A major strength of our study was that we referred all of those individuals for a structured follow-up within the study,” she said. “Although the focus of the follow-up was oral anticoagulant therapy, other risk factors were also assessed and managed, such as hypertension and diabetes.”

It’s possible that increased detection of AF followed by such structured management contributed to the observed benefit, Dr. Svennberg proposed.

However, the exclusion of those in the prespecified ITT population who declined to be screened or otherwise didn’t participate left an as-treated cohort that was healthier than the ITT population or the control group.

Indeed, the nonparticipating invitees were sicker, with significantly more diabetes, vascular disease, hypertension, and heart failure, and higher CHA2DS2VASc stroke risk scores than those who agreed to participate.

“We took a more difficult route in setting up this study, in that we identified all individuals aged 75 to 76 residing in our two regions and excluded no one,” Dr. Svennberg said in an interview. “That means even individuals with end-stage disease, severe dementia, bedridden in nursing homes, et cetera, were also randomized but perhaps not likely or eligible to participate.”

Therefore, some invitees were unable to join the study even as others might have declined “out of low interest” or other personal reasons, she said. “We believe that this mimics how a population-based screening program would be performed if done in our country.”

In the ITT analysis, screening successfully identified previously unknown or untreated cases of AF, which led to expanded OAC use and intensified risk-factor management, “which was key to a successful outcome.”

In the as-treated analysis, Dr. Svennberg said, “I think a combination of the intervention and the population being overall more healthy was driving the secondary endpoint.”
 

Systematic vs. opportunistic screening

Although “opportunistic screening in individuals aged 65 and older” is recommended by current European Society of Cardiology guidelines, systematic screening, such as that used in STROKESTOP, has a much weaker evidence base, observed Renate B. Schnabel, MD, PhD, University Heart & Vascular Center, Hamburg, Germany, as the invited discussant after the STROKESTOP presentation.

STROKESTOP “is one of the first studies, if not the first study,” to show a clinical benefit from screening for AF, Dr. Schnabel said.

Fewer-than-projected primary outcome events were seen during the trial, and event curves for screened and control participants didn’t start to separate until about 4 years into the study, she said. It therefore might take a long time for the screened elderly to realize the clinical benefits of screening.

Studies such as the recent SCREEN-AF and mSTOPS have amply shown that AF screening in the asymptomatic elderly can reveal previously unrecognized AF far more often than would be detected in routine practice, allowing them the opportunity to go on OAC. But the trials weren’t able to show whether the benefits of such management outweigh the risks or costs.

Indeed, on April 20, the U.S. Preventive Services Task Force (USPSTF) released a draft recommendation statement concluding that “the current evidence is insufficient to assess the balance of benefits and harms” associated with AF screening in asymptomatic people at least 50 years of age.

In STROKESTOP, however, benefit for the primary outcome reached significance in the prespecified ITT analysis and “appeared to be driven by the reduction in ischemic stroke incidence,” Dr. Schnabel said.

“The future guidelines have gained strong evidence to judge on systematic atrial fibrillation screening” as it was performed in the trial, she said. “How to implement atrial fibrillation screening, including systematic screening in health care systems across Europe and beyond, remains an open question.”
 

A randomized population

STROKESTOP considered all 75- and 76-year-olds living in Sweden’s Stockholm County (n = 23,888) and the Halland region (n = 4,880) and randomly assigned them to the ITT group or a control group, with stratification by sex, birth year, and geographic region. In both groups, 54.6% were female and the mean CHA2DS2VASc score was 3.5.

People assigned to the ITT cohort were invited to be screened and followed. Those who agreed to participate underwent a baseline ECG assessment to detect or rule out permanent AF. Guideline-based OAC and follow-up was offered to those found with the arrhythmia. Those in sinus rhythm with no history of AF used a handheld single-lead ECG recorder (Zenicor) for 30 seconds twice daily for 14 days.

Structured management, including OAC, was offered to anyone demonstrating sufficient AF, that is, at least one bout without p waves in one 30-second recording or at least two such episodes lasting 10-29 seconds during the 2-week screening period.

In the ITT analysis, the hazard ratio (HR) for the composite clinical primary endpoint was 0.96 (95% confidence interval, 0.920-0.999; P = .045), but in the as-treated analysis, the HR for ischemic stroke was 0.76 (95% CI, 0.68-0.87; P < .001).

“I believe that this will likely be generalizable to most countries’ elderly residents,” Dr. Svennberg said. “I think if we can find a significant difference in our elderly population in Sweden, most countries will be able to do so, or find even more significant results.”

That’s because “baseline detection of AF in Sweden is high,” she said, “so new detection is likely more difficult.” Also, in Sweden, “care can be sought without monetary concern, and prescriptions are provided at low costs to the patients.” Therefore, patients newly identified with AF, whether in studies or not, “would likely be started on therapy.”

It will be important to know whether the screening strategy is cost-effective, Dr. Schnabel said, because “the overall effect, with a hazard ratio of 0.96, is not too big, and costs incurred by systematic screening are comparatively high.”

STROKESTOP “now provides sound information for cost-effectiveness analyses, which to date have largely relied on assumptions.”

STROKESTOP was partially supported by Carl Bennet AB, Boehringer-Ingelheim, Bayer, Bristol-Meyers Squibb, and Pfizer. Dr. Svennberg disclosed receiving fees for lectures or consulting from Bayer, Bristol-Meyers Squibb, Pfizer, Boehringer-Ingelheim, Merck Sharp & Dohme, and Sanofi; and institutional grants from Roche Diagnostics and Carl Bennett Ltd.

A version of this article first appeared on Medscape.com.

Some, perhaps many, previously unrecognized cases of atrial fibrillation (AF) will come to light in a screening program aimed at older asymptomatic adults. The key question is whether the challenges of such systematic but age-restricted AF screening in the community, with oral anticoagulation (OAC) offered to those found to have the arrhythmia, is worthwhile in preventing events such as death or stroke.
 

Now there is evidence supporting such a clinical benefit from a large, prospective, randomized trial. A screening program restricted to people 75 or 76 years of age in two Swedish communities, which called on them to use a handheld single-lead ECG system at home intermittently for 2 weeks, was followed by a slight drop in clinical events over about 7 years.

The 4% decline in risk (P = .045) in the STROKESTOP trial’s “intention-to-treat” (ITT) analysis yielded a number needed to treat of 91; that is, that many people had to be targeted by the screening program to prevent one primary-endpoint clinical event.

Those included ischemic stroke, systemic thromboembolism, hospitalization for severe bleeding, and death from any cause, investigators reported April 23 during the virtual European Heart Rhythm Association (EHRA) 2021 Congress.

If that benefit and its significance seem marginal, some secondary findings might be reassuring. Half the population of the target age in the two communities – 13,979 randomly selected people – were invited to join the trial and follow the screening protocol, comprising the ITT cohort. The other half, numbering 13,996, was not invited and served as control subjects.

However, only 51% of the ITT cohort accepted the invitation and participated in the trial; they represented the “as-treated” cohort, observed Emma Svennberg, MD, PhD, Karolinska Institute, Danderyd Hospital, Stockholm, who presented the analysis at the EHRA sessions.

The screening protocol identified untreated AF, whether previously known or unknown, in about 5% of the 7,165 as-treated screening participants; OAC was initiated in about three-fourths of those cases.

The as-treated group, on their own, benefited with a 24% drop in the prospectively defined secondary endpoint of ischemic stroke, compared with the entire control group.

The clinical benefit in the ITT population was “small but significant,” but over the same period in the as-treated cohort, there was a highly significant drop in risk for ischemic stroke, Dr. Svennberg said in an interview.

The trial’s lead message, she said, is that “screening for atrial fibrillation in an elderly population reduces the risk of death and ischemic stroke without increasing the risk of bleeding.”
 

Caveats: As-treated vs. ITT

But there are caveats that complicate interpretation of the trial and, Dr. Svennberg proposed, point to the importance of that interpretation of both the ITT and as-treated analyses.

“We detected significantly more atrial fibrillation in the group that was randomized to screening. A major strength of our study was that we referred all of those individuals for a structured follow-up within the study,” she said. “Although the focus of the follow-up was oral anticoagulant therapy, other risk factors were also assessed and managed, such as hypertension and diabetes.”

It’s possible that increased detection of AF followed by such structured management contributed to the observed benefit, Dr. Svennberg proposed.

However, the exclusion of those in the prespecified ITT population who declined to be screened or otherwise didn’t participate left an as-treated cohort that was healthier than the ITT population or the control group.

Indeed, the nonparticipating invitees were sicker, with significantly more diabetes, vascular disease, hypertension, and heart failure, and higher CHA2DS2VASc stroke risk scores than those who agreed to participate.

“We took a more difficult route in setting up this study, in that we identified all individuals aged 75 to 76 residing in our two regions and excluded no one,” Dr. Svennberg said in an interview. “That means even individuals with end-stage disease, severe dementia, bedridden in nursing homes, et cetera, were also randomized but perhaps not likely or eligible to participate.”

Therefore, some invitees were unable to join the study even as others might have declined “out of low interest” or other personal reasons, she said. “We believe that this mimics how a population-based screening program would be performed if done in our country.”

In the ITT analysis, screening successfully identified previously unknown or untreated cases of AF, which led to expanded OAC use and intensified risk-factor management, “which was key to a successful outcome.”

In the as-treated analysis, Dr. Svennberg said, “I think a combination of the intervention and the population being overall more healthy was driving the secondary endpoint.”
 

Systematic vs. opportunistic screening

Although “opportunistic screening in individuals aged 65 and older” is recommended by current European Society of Cardiology guidelines, systematic screening, such as that used in STROKESTOP, has a much weaker evidence base, observed Renate B. Schnabel, MD, PhD, University Heart & Vascular Center, Hamburg, Germany, as the invited discussant after the STROKESTOP presentation.

STROKESTOP “is one of the first studies, if not the first study,” to show a clinical benefit from screening for AF, Dr. Schnabel said.

Fewer-than-projected primary outcome events were seen during the trial, and event curves for screened and control participants didn’t start to separate until about 4 years into the study, she said. It therefore might take a long time for the screened elderly to realize the clinical benefits of screening.

Studies such as the recent SCREEN-AF and mSTOPS have amply shown that AF screening in the asymptomatic elderly can reveal previously unrecognized AF far more often than would be detected in routine practice, allowing them the opportunity to go on OAC. But the trials weren’t able to show whether the benefits of such management outweigh the risks or costs.

Indeed, on April 20, the U.S. Preventive Services Task Force (USPSTF) released a draft recommendation statement concluding that “the current evidence is insufficient to assess the balance of benefits and harms” associated with AF screening in asymptomatic people at least 50 years of age.

In STROKESTOP, however, benefit for the primary outcome reached significance in the prespecified ITT analysis and “appeared to be driven by the reduction in ischemic stroke incidence,” Dr. Schnabel said.

“The future guidelines have gained strong evidence to judge on systematic atrial fibrillation screening” as it was performed in the trial, she said. “How to implement atrial fibrillation screening, including systematic screening in health care systems across Europe and beyond, remains an open question.”
 

A randomized population

STROKESTOP considered all 75- and 76-year-olds living in Sweden’s Stockholm County (n = 23,888) and the Halland region (n = 4,880) and randomly assigned them to the ITT group or a control group, with stratification by sex, birth year, and geographic region. In both groups, 54.6% were female and the mean CHA2DS2VASc score was 3.5.

People assigned to the ITT cohort were invited to be screened and followed. Those who agreed to participate underwent a baseline ECG assessment to detect or rule out permanent AF. Guideline-based OAC and follow-up was offered to those found with the arrhythmia. Those in sinus rhythm with no history of AF used a handheld single-lead ECG recorder (Zenicor) for 30 seconds twice daily for 14 days.

Structured management, including OAC, was offered to anyone demonstrating sufficient AF, that is, at least one bout without p waves in one 30-second recording or at least two such episodes lasting 10-29 seconds during the 2-week screening period.

In the ITT analysis, the hazard ratio (HR) for the composite clinical primary endpoint was 0.96 (95% confidence interval, 0.920-0.999; P = .045), but in the as-treated analysis, the HR for ischemic stroke was 0.76 (95% CI, 0.68-0.87; P < .001).

“I believe that this will likely be generalizable to most countries’ elderly residents,” Dr. Svennberg said. “I think if we can find a significant difference in our elderly population in Sweden, most countries will be able to do so, or find even more significant results.”

That’s because “baseline detection of AF in Sweden is high,” she said, “so new detection is likely more difficult.” Also, in Sweden, “care can be sought without monetary concern, and prescriptions are provided at low costs to the patients.” Therefore, patients newly identified with AF, whether in studies or not, “would likely be started on therapy.”

It will be important to know whether the screening strategy is cost-effective, Dr. Schnabel said, because “the overall effect, with a hazard ratio of 0.96, is not too big, and costs incurred by systematic screening are comparatively high.”

STROKESTOP “now provides sound information for cost-effectiveness analyses, which to date have largely relied on assumptions.”

STROKESTOP was partially supported by Carl Bennet AB, Boehringer-Ingelheim, Bayer, Bristol-Meyers Squibb, and Pfizer. Dr. Svennberg disclosed receiving fees for lectures or consulting from Bayer, Bristol-Meyers Squibb, Pfizer, Boehringer-Ingelheim, Merck Sharp & Dohme, and Sanofi; and institutional grants from Roche Diagnostics and Carl Bennett Ltd.

A version of this article first appeared on Medscape.com.

Second-line treatment with sintilimab improved survival, when compared with docetaxel, in patients with advanced/metastatic squamous non–small cell lung cancer (sqNSCLC) in a phase 3 trial.

Sintilimab improved both overall survival (OS) and progression-free survival (PFS), according to Yuankai Shi, MD, of the Chinese Academy of Medical Sciences & Peking Union Medical College in Beijing.

Dr. Shi presented these findings, from the ORIENT-3 study, at the American Association for Cancer Research Annual Meeting 2021: Week 1 (Abstract CT041).

ORIENT-3 enrolled and randomized 290 patients with stage IIIB/IIIC or IV sqNSCLC and disease progression during or after first-line platimum-based chemotherapy. They were randomized 1:1 to receive sintilimab at 200 mg or docetaxel at 75 mg/m²intravenously every 3 weeks until disease progression or intolerable toxicity.

The median age was 60 years in the sintilimab arm and 61 years in the docetaxel arm. A majority of patients were men (94% in the sintilimab arm and 90% in the docetaxel arm), most were current or former smokers (90% and 80%, respectively), and more than three-quarters had an ECOG performance status of 1 (76% and 77%, respectively). More than half of patients had a PD-L1 tumor proportion score (TPS) of 1% or greater (57% and 47%, respectively), and 81% of patients in both arms had stage IV disease.

Results: Survival and safety

Patients in the sintilimab arm received a median of 8.0 cycles of therapy (range, 1-45), and those in the docetaxel arm received a median of 2.0 cycles of therapy (range, 1-15).

At a median follow-up of 23.56 months, the median OS was significantly longer in the sintilimab arm than in the docetaxel arm – 11.79 months and 8.25 months, respectively (hazard ratio, 0.74; P = .02489). OS benefits were generally consistent across subgroups.

The secondary endpoints of PFS and objective response rate also favored sintilimab, Dr. Shi reported.

The median PFS was 4.30 months in the sintilimab arm and 2.79 months in the docetaxel arm (HR, 0.52; P < .00001). Confirmed objective response rates were 25.5% and 2.2%, respectively; the median duration of response was 12.45 months and 4.14 months, respectively; and disease control rates were 65.5% and 37.8%, respectively.

“Sintilimab had a favorable safety profile over docetaxel, with a lower frequency of grade 3 or higher treatment-related adverse events, with no new safety signals observed,” Dr. Shi said.

Treatment-related adverse events (TRAEs) occurred in 84.7% of patients receiving sintilimab and 83.1% of those receiving docetaxel. Hypothyroidism was the most common TRAE in the sintilimab arm (18.1%), and alopecia was the most common TRAE in the docetaxel arm (34.6%).

Grade 3 or higher TRAEs were less frequent in the sintilimab arm than in the docetaxel arm (18.1% vs. 36.2%). Rates of discontinuation because of TRAEs were 12.5% and 5.4% in the sintilimab and docetaxel arms, respectively. TRAEs leading to death occurred in five patients in the sintilimab arm and one in the docetaxel arm.

Use in the real world

Noting sintilimab’s significant OS and PFS benefits as well as superior response rate and duration of response, Dr. Shi concluded, “Sintilimab might provide an alternative second-line treatment option for advanced and metastatic sqNSCLC.”

AACR moderator Marina Garassino, MD, of the University of Chicago, commented on the potential utility of sintilimab and tislelizumab, another checkpoint inhibitor that was evaluated in NSCLC in the RATIONALE 303 trial (AACR 2021, Abstract CT039). Dr. Garassino observed that both drugs have demonstrated superiority to docetaxel as second-line therapy in NSCLC.

Although there have been no head-to-head trials, sintilimab and tislelizumab appear to be very similar to the already approved immune checkpoint inhibitors, which are currently being used as first-line treatment.

“That similarity would make them inappropriate for second-line treatment, except in countries where immune checkpoint inhibitors are not yet approved for first-line therapy,” Dr. Garassino noted.

When asked to comment on the higher treatment-related death rate observed with sintilimab, Dr. Garassino said, “We need to remember that these drugs were developed in China with a population that may have a side effect profile differing from that of a Western population. Also, we are very familiar with this class of drugs and know how to treat their side effects. Similar drugs but different populations and different trials, so it’s very hard to judge.”

Dr. Garassino speculated that with the “super expensive” price tags on the new checkpoint inhibitors, having additional agents that could provide choice and drive prices down would be welcome.

ORIENT-3 was funded by Innovent Biologics and Eli Lilly. Dr. Shi disclosed consultancy for Innovent Biologics. Dr. Garassino disclosed relationships with Eli Lilly, AstraZeneca, Novartis, and several other companies, not including Innovent Biologics.

Second-line treatment with sintilimab improved survival, when compared with docetaxel, in patients with advanced/metastatic squamous non–small cell lung cancer (sqNSCLC) in a phase 3 trial.

Sintilimab improved both overall survival (OS) and progression-free survival (PFS), according to Yuankai Shi, MD, of the Chinese Academy of Medical Sciences & Peking Union Medical College in Beijing.

Dr. Shi presented these findings, from the ORIENT-3 study, at the American Association for Cancer Research Annual Meeting 2021: Week 1 (Abstract CT041).

ORIENT-3 enrolled and randomized 290 patients with stage IIIB/IIIC or IV sqNSCLC and disease progression during or after first-line platimum-based chemotherapy. They were randomized 1:1 to receive sintilimab at 200 mg or docetaxel at 75 mg/m²intravenously every 3 weeks until disease progression or intolerable toxicity.

The median age was 60 years in the sintilimab arm and 61 years in the docetaxel arm. A majority of patients were men (94% in the sintilimab arm and 90% in the docetaxel arm), most were current or former smokers (90% and 80%, respectively), and more than three-quarters had an ECOG performance status of 1 (76% and 77%, respectively). More than half of patients had a PD-L1 tumor proportion score (TPS) of 1% or greater (57% and 47%, respectively), and 81% of patients in both arms had stage IV disease.

Results: Survival and safety

Patients in the sintilimab arm received a median of 8.0 cycles of therapy (range, 1-45), and those in the docetaxel arm received a median of 2.0 cycles of therapy (range, 1-15).

At a median follow-up of 23.56 months, the median OS was significantly longer in the sintilimab arm than in the docetaxel arm – 11.79 months and 8.25 months, respectively (hazard ratio, 0.74; P = .02489). OS benefits were generally consistent across subgroups.

The secondary endpoints of PFS and objective response rate also favored sintilimab, Dr. Shi reported.

The median PFS was 4.30 months in the sintilimab arm and 2.79 months in the docetaxel arm (HR, 0.52; P < .00001). Confirmed objective response rates were 25.5% and 2.2%, respectively; the median duration of response was 12.45 months and 4.14 months, respectively; and disease control rates were 65.5% and 37.8%, respectively.

“Sintilimab had a favorable safety profile over docetaxel, with a lower frequency of grade 3 or higher treatment-related adverse events, with no new safety signals observed,” Dr. Shi said.

Treatment-related adverse events (TRAEs) occurred in 84.7% of patients receiving sintilimab and 83.1% of those receiving docetaxel. Hypothyroidism was the most common TRAE in the sintilimab arm (18.1%), and alopecia was the most common TRAE in the docetaxel arm (34.6%).

Grade 3 or higher TRAEs were less frequent in the sintilimab arm than in the docetaxel arm (18.1% vs. 36.2%). Rates of discontinuation because of TRAEs were 12.5% and 5.4% in the sintilimab and docetaxel arms, respectively. TRAEs leading to death occurred in five patients in the sintilimab arm and one in the docetaxel arm.

Use in the real world

Noting sintilimab’s significant OS and PFS benefits as well as superior response rate and duration of response, Dr. Shi concluded, “Sintilimab might provide an alternative second-line treatment option for advanced and metastatic sqNSCLC.”

AACR moderator Marina Garassino, MD, of the University of Chicago, commented on the potential utility of sintilimab and tislelizumab, another checkpoint inhibitor that was evaluated in NSCLC in the RATIONALE 303 trial (AACR 2021, Abstract CT039). Dr. Garassino observed that both drugs have demonstrated superiority to docetaxel as second-line therapy in NSCLC.

Although there have been no head-to-head trials, sintilimab and tislelizumab appear to be very similar to the already approved immune checkpoint inhibitors, which are currently being used as first-line treatment.

“That similarity would make them inappropriate for second-line treatment, except in countries where immune checkpoint inhibitors are not yet approved for first-line therapy,” Dr. Garassino noted.

When asked to comment on the higher treatment-related death rate observed with sintilimab, Dr. Garassino said, “We need to remember that these drugs were developed in China with a population that may have a side effect profile differing from that of a Western population. Also, we are very familiar with this class of drugs and know how to treat their side effects. Similar drugs but different populations and different trials, so it’s very hard to judge.”

Dr. Garassino speculated that with the “super expensive” price tags on the new checkpoint inhibitors, having additional agents that could provide choice and drive prices down would be welcome.

ORIENT-3 was funded by Innovent Biologics and Eli Lilly. Dr. Shi disclosed consultancy for Innovent Biologics. Dr. Garassino disclosed relationships with Eli Lilly, AstraZeneca, Novartis, and several other companies, not including Innovent Biologics.

Second-line treatment with sintilimab improved survival, when compared with docetaxel, in patients with advanced/metastatic squamous non–small cell lung cancer (sqNSCLC) in a phase 3 trial.

Sintilimab improved both overall survival (OS) and progression-free survival (PFS), according to Yuankai Shi, MD, of the Chinese Academy of Medical Sciences & Peking Union Medical College in Beijing.

Dr. Shi presented these findings, from the ORIENT-3 study, at the American Association for Cancer Research Annual Meeting 2021: Week 1 (Abstract CT041).

ORIENT-3 enrolled and randomized 290 patients with stage IIIB/IIIC or IV sqNSCLC and disease progression during or after first-line platimum-based chemotherapy. They were randomized 1:1 to receive sintilimab at 200 mg or docetaxel at 75 mg/m²intravenously every 3 weeks until disease progression or intolerable toxicity.

The median age was 60 years in the sintilimab arm and 61 years in the docetaxel arm. A majority of patients were men (94% in the sintilimab arm and 90% in the docetaxel arm), most were current or former smokers (90% and 80%, respectively), and more than three-quarters had an ECOG performance status of 1 (76% and 77%, respectively). More than half of patients had a PD-L1 tumor proportion score (TPS) of 1% or greater (57% and 47%, respectively), and 81% of patients in both arms had stage IV disease.

Results: Survival and safety

Patients in the sintilimab arm received a median of 8.0 cycles of therapy (range, 1-45), and those in the docetaxel arm received a median of 2.0 cycles of therapy (range, 1-15).

At a median follow-up of 23.56 months, the median OS was significantly longer in the sintilimab arm than in the docetaxel arm – 11.79 months and 8.25 months, respectively (hazard ratio, 0.74; P = .02489). OS benefits were generally consistent across subgroups.

The secondary endpoints of PFS and objective response rate also favored sintilimab, Dr. Shi reported.

The median PFS was 4.30 months in the sintilimab arm and 2.79 months in the docetaxel arm (HR, 0.52; P < .00001). Confirmed objective response rates were 25.5% and 2.2%, respectively; the median duration of response was 12.45 months and 4.14 months, respectively; and disease control rates were 65.5% and 37.8%, respectively.

“Sintilimab had a favorable safety profile over docetaxel, with a lower frequency of grade 3 or higher treatment-related adverse events, with no new safety signals observed,” Dr. Shi said.

Treatment-related adverse events (TRAEs) occurred in 84.7% of patients receiving sintilimab and 83.1% of those receiving docetaxel. Hypothyroidism was the most common TRAE in the sintilimab arm (18.1%), and alopecia was the most common TRAE in the docetaxel arm (34.6%).

Grade 3 or higher TRAEs were less frequent in the sintilimab arm than in the docetaxel arm (18.1% vs. 36.2%). Rates of discontinuation because of TRAEs were 12.5% and 5.4% in the sintilimab and docetaxel arms, respectively. TRAEs leading to death occurred in five patients in the sintilimab arm and one in the docetaxel arm.

Use in the real world

Noting sintilimab’s significant OS and PFS benefits as well as superior response rate and duration of response, Dr. Shi concluded, “Sintilimab might provide an alternative second-line treatment option for advanced and metastatic sqNSCLC.”

AACR moderator Marina Garassino, MD, of the University of Chicago, commented on the potential utility of sintilimab and tislelizumab, another checkpoint inhibitor that was evaluated in NSCLC in the RATIONALE 303 trial (AACR 2021, Abstract CT039). Dr. Garassino observed that both drugs have demonstrated superiority to docetaxel as second-line therapy in NSCLC.

Although there have been no head-to-head trials, sintilimab and tislelizumab appear to be very similar to the already approved immune checkpoint inhibitors, which are currently being used as first-line treatment.

“That similarity would make them inappropriate for second-line treatment, except in countries where immune checkpoint inhibitors are not yet approved for first-line therapy,” Dr. Garassino noted.

When asked to comment on the higher treatment-related death rate observed with sintilimab, Dr. Garassino said, “We need to remember that these drugs were developed in China with a population that may have a side effect profile differing from that of a Western population. Also, we are very familiar with this class of drugs and know how to treat their side effects. Similar drugs but different populations and different trials, so it’s very hard to judge.”

Dr. Garassino speculated that with the “super expensive” price tags on the new checkpoint inhibitors, having additional agents that could provide choice and drive prices down would be welcome.

ORIENT-3 was funded by Innovent Biologics and Eli Lilly. Dr. Shi disclosed consultancy for Innovent Biologics. Dr. Garassino disclosed relationships with Eli Lilly, AstraZeneca, Novartis, and several other companies, not including Innovent Biologics.

The Food and Drug Administration said that within a year it will ban menthol in cigarettes and ban all flavors including menthol in cigars.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, the FDA said in announcing its actions on Thursday.

Nineteen organizations – including the American Academy of Pediatrics, American Cancer Society, American College of Chest Physicians, American Medical Association, American Heart Association, and the National Medical Association – have pushed the FDA to ban menthol for years. The agency banned all flavors in cigarettes in 2009 but did not take any action against menthol. In 2013, the groups filed a petition demanding that the FDA ban menthol, too. The agency responded months later with a notice that it would start the process.

But it never took any action. Action on Smoking and Health and the African American Tobacco Control Leadership Council, later joined by the AMA and the NMA, sued in 2020 to compel the agency to do something. Now it has finally agreed to act.

The African American Tobacco Control Leadership Council welcomed the move but said the fight is not over and encouraged tobacco control activists to fight to ban menthol tobacco products at the local, state and federal level. “We know that this rule-making process could take years and we know that the tobacco industry will continue to do everything in their power to derail any attempt to remove their deadly products from the market,” Phillip Gardiner, MD, council cochair, said in a statement.

The AMA is urging the FDA to quickly implement the ban and remove the products “without further delay,” AMA President Susan R. Bailey, MD, said in a statement.

“FDA’s long-awaited decision to take action to eliminate menthol flavoring in cigarettes and all flavors in cigars ends a decades-long deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in her own statement.

Ms. Lacasse said banning menthol will help eliminate health disparities. She said 86% of Black people who smoke use menthol cigarettes, compared with 46% of Hispanic people who smoke, 39% of Asian people who smoke, and 29% of White people who smoke. “FDA’s actions today send a clear message that Big Tobacco’s strategy to profit off addicting Black communities will no longer be tolerated,” she said.

Not all groups are on board, however. The American Civil Liberties Union and several other organizations wrote to the country’s top health officials urging them to reconsider.

“Such a ban will trigger criminal penalties which will disproportionately impact people of color, as well as prioritize criminalization over public health and harm reduction,” the letter says. “A ban will also lead to unconstitutional policing and other negative interactions with local law enforcement.”

The letter calls the proposed ban “well intentioned,” but said any effort to reduce death and disease from tobacco “must avoid solutions that will create yet another reason for armed police to engage citizens on the street based on pretext or conduct that does not pose a threat to public safety.”

Instead of a ban, the organizations said, policy makers should consider increased education for adults and minors, stop-smoking programs, and increased funding for health centers in communities of color.

The Biden administration, however, pressed the point that banning menthol will bring many positives. Acting FDA Commissioner Janet Woodcock, MD said in a statement that banning menthol “will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ-plus individuals, all of whom are far more likely to use these tobacco products.”

The FDA cited data showing that, in the first year or so after a ban goes into effect, an additional 923,000 smokers would quit, including 230,000 African Americans. Another study suggests that 633,000 deaths would be averted, including 237,000 Black Americans.

Dr. Woodcock added that, “armed with strong scientific evidence, and with full support from the [Biden] administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.”

The FDA estimates that 18.6 million Americans who are current smokers use menthol cigarettes, with a disproportionately high number being Black people. Menthol cigarette use among Black and Hispanic youth increased from 2011 to 2018, but declined for non-Hispanic White youth.

Flavored mass-produced cigars and cigarillos are disproportionately popular among youth, especially non-Hispanic Black high school students, who in 2020 reported past 30-day cigar smoking at levels twice as high as their White counterparts, said the FDA. Three-quarters of 12- to 17-year-olds reported they smoke cigars because they like the flavors. In 2020, more young people tried a cigar every day than tried a cigarette, reports the agency.

“This long-overdue decision will protect future generations of young people from nicotine addiction, especially Black children and communities, which have disproportionately suffered from menthol tobacco use due to targeted efforts from the tobacco industry,” Lee Savio Beers, MD, president of the American Academy of Pediatrics, said in a statement.

The FDA’s announcement “is only a first step that must be followed with urgent, comprehensive action to remove these flavored products from the market,” he said.

A version of this article first appeared on WebMD.com.

The Food and Drug Administration said that within a year it will ban menthol in cigarettes and ban all flavors including menthol in cigars.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, the FDA said in announcing its actions on Thursday.

Nineteen organizations – including the American Academy of Pediatrics, American Cancer Society, American College of Chest Physicians, American Medical Association, American Heart Association, and the National Medical Association – have pushed the FDA to ban menthol for years. The agency banned all flavors in cigarettes in 2009 but did not take any action against menthol. In 2013, the groups filed a petition demanding that the FDA ban menthol, too. The agency responded months later with a notice that it would start the process.

But it never took any action. Action on Smoking and Health and the African American Tobacco Control Leadership Council, later joined by the AMA and the NMA, sued in 2020 to compel the agency to do something. Now it has finally agreed to act.

The African American Tobacco Control Leadership Council welcomed the move but said the fight is not over and encouraged tobacco control activists to fight to ban menthol tobacco products at the local, state and federal level. “We know that this rule-making process could take years and we know that the tobacco industry will continue to do everything in their power to derail any attempt to remove their deadly products from the market,” Phillip Gardiner, MD, council cochair, said in a statement.

The AMA is urging the FDA to quickly implement the ban and remove the products “without further delay,” AMA President Susan R. Bailey, MD, said in a statement.

“FDA’s long-awaited decision to take action to eliminate menthol flavoring in cigarettes and all flavors in cigars ends a decades-long deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in her own statement.

Ms. Lacasse said banning menthol will help eliminate health disparities. She said 86% of Black people who smoke use menthol cigarettes, compared with 46% of Hispanic people who smoke, 39% of Asian people who smoke, and 29% of White people who smoke. “FDA’s actions today send a clear message that Big Tobacco’s strategy to profit off addicting Black communities will no longer be tolerated,” she said.

Not all groups are on board, however. The American Civil Liberties Union and several other organizations wrote to the country’s top health officials urging them to reconsider.

“Such a ban will trigger criminal penalties which will disproportionately impact people of color, as well as prioritize criminalization over public health and harm reduction,” the letter says. “A ban will also lead to unconstitutional policing and other negative interactions with local law enforcement.”

The letter calls the proposed ban “well intentioned,” but said any effort to reduce death and disease from tobacco “must avoid solutions that will create yet another reason for armed police to engage citizens on the street based on pretext or conduct that does not pose a threat to public safety.”

Instead of a ban, the organizations said, policy makers should consider increased education for adults and minors, stop-smoking programs, and increased funding for health centers in communities of color.

The Biden administration, however, pressed the point that banning menthol will bring many positives. Acting FDA Commissioner Janet Woodcock, MD said in a statement that banning menthol “will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ-plus individuals, all of whom are far more likely to use these tobacco products.”

The FDA cited data showing that, in the first year or so after a ban goes into effect, an additional 923,000 smokers would quit, including 230,000 African Americans. Another study suggests that 633,000 deaths would be averted, including 237,000 Black Americans.

Dr. Woodcock added that, “armed with strong scientific evidence, and with full support from the [Biden] administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.”

The FDA estimates that 18.6 million Americans who are current smokers use menthol cigarettes, with a disproportionately high number being Black people. Menthol cigarette use among Black and Hispanic youth increased from 2011 to 2018, but declined for non-Hispanic White youth.

Flavored mass-produced cigars and cigarillos are disproportionately popular among youth, especially non-Hispanic Black high school students, who in 2020 reported past 30-day cigar smoking at levels twice as high as their White counterparts, said the FDA. Three-quarters of 12- to 17-year-olds reported they smoke cigars because they like the flavors. In 2020, more young people tried a cigar every day than tried a cigarette, reports the agency.

“This long-overdue decision will protect future generations of young people from nicotine addiction, especially Black children and communities, which have disproportionately suffered from menthol tobacco use due to targeted efforts from the tobacco industry,” Lee Savio Beers, MD, president of the American Academy of Pediatrics, said in a statement.

The FDA’s announcement “is only a first step that must be followed with urgent, comprehensive action to remove these flavored products from the market,” he said.

A version of this article first appeared on WebMD.com.

The Food and Drug Administration said that within a year it will ban menthol in cigarettes and ban all flavors including menthol in cigars.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, the FDA said in announcing its actions on Thursday.

Nineteen organizations – including the American Academy of Pediatrics, American Cancer Society, American College of Chest Physicians, American Medical Association, American Heart Association, and the National Medical Association – have pushed the FDA to ban menthol for years. The agency banned all flavors in cigarettes in 2009 but did not take any action against menthol. In 2013, the groups filed a petition demanding that the FDA ban menthol, too. The agency responded months later with a notice that it would start the process.

But it never took any action. Action on Smoking and Health and the African American Tobacco Control Leadership Council, later joined by the AMA and the NMA, sued in 2020 to compel the agency to do something. Now it has finally agreed to act.

The African American Tobacco Control Leadership Council welcomed the move but said the fight is not over and encouraged tobacco control activists to fight to ban menthol tobacco products at the local, state and federal level. “We know that this rule-making process could take years and we know that the tobacco industry will continue to do everything in their power to derail any attempt to remove their deadly products from the market,” Phillip Gardiner, MD, council cochair, said in a statement.

The AMA is urging the FDA to quickly implement the ban and remove the products “without further delay,” AMA President Susan R. Bailey, MD, said in a statement.

“FDA’s long-awaited decision to take action to eliminate menthol flavoring in cigarettes and all flavors in cigars ends a decades-long deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in her own statement.

Ms. Lacasse said banning menthol will help eliminate health disparities. She said 86% of Black people who smoke use menthol cigarettes, compared with 46% of Hispanic people who smoke, 39% of Asian people who smoke, and 29% of White people who smoke. “FDA’s actions today send a clear message that Big Tobacco’s strategy to profit off addicting Black communities will no longer be tolerated,” she said.

Not all groups are on board, however. The American Civil Liberties Union and several other organizations wrote to the country’s top health officials urging them to reconsider.

“Such a ban will trigger criminal penalties which will disproportionately impact people of color, as well as prioritize criminalization over public health and harm reduction,” the letter says. “A ban will also lead to unconstitutional policing and other negative interactions with local law enforcement.”

The letter calls the proposed ban “well intentioned,” but said any effort to reduce death and disease from tobacco “must avoid solutions that will create yet another reason for armed police to engage citizens on the street based on pretext or conduct that does not pose a threat to public safety.”

Instead of a ban, the organizations said, policy makers should consider increased education for adults and minors, stop-smoking programs, and increased funding for health centers in communities of color.

The Biden administration, however, pressed the point that banning menthol will bring many positives. Acting FDA Commissioner Janet Woodcock, MD said in a statement that banning menthol “will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ-plus individuals, all of whom are far more likely to use these tobacco products.”

The FDA cited data showing that, in the first year or so after a ban goes into effect, an additional 923,000 smokers would quit, including 230,000 African Americans. Another study suggests that 633,000 deaths would be averted, including 237,000 Black Americans.

Dr. Woodcock added that, “armed with strong scientific evidence, and with full support from the [Biden] administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.”

The FDA estimates that 18.6 million Americans who are current smokers use menthol cigarettes, with a disproportionately high number being Black people. Menthol cigarette use among Black and Hispanic youth increased from 2011 to 2018, but declined for non-Hispanic White youth.

Flavored mass-produced cigars and cigarillos are disproportionately popular among youth, especially non-Hispanic Black high school students, who in 2020 reported past 30-day cigar smoking at levels twice as high as their White counterparts, said the FDA. Three-quarters of 12- to 17-year-olds reported they smoke cigars because they like the flavors. In 2020, more young people tried a cigar every day than tried a cigarette, reports the agency.

“This long-overdue decision will protect future generations of young people from nicotine addiction, especially Black children and communities, which have disproportionately suffered from menthol tobacco use due to targeted efforts from the tobacco industry,” Lee Savio Beers, MD, president of the American Academy of Pediatrics, said in a statement.

The FDA’s announcement “is only a first step that must be followed with urgent, comprehensive action to remove these flavored products from the market,” he said.

A version of this article first appeared on WebMD.com.

COVID-19 survivors are at risk from a possible second pandemic, this time of opioid addiction, given the high rate of painkillers being prescribed to these patients, health experts say.

sdominick/Getty Images

A new study in Nature found alarmingly high rates of opioid use among COVID survivors with lingering symptoms at Veterans Affairs facilities. About 10% of COVID survivors develop “long COVID,” struggling with often disabling health problems even 6 months or longer after a diagnosis.

For every 1,000 long-COVID patients, known as “long-haulers,” who were treated at a VA facility, doctors wrote nine more prescriptions for opioids than they otherwise would have, along with 22 additional prescriptions for benzodiazepines, which include Xanax and other addictive pills used to treat anxiety.

Although previous studies have found many COVID survivors experience persistent health problems, the new article is the first to show they’re using more addictive medications, said Ziyad Al-Aly, MD, the paper’s lead author.

He’s concerned that even an apparently small increase in the inappropriate use of addictive pain pills will lead to a resurgence of the prescription opioid crisis, given the large number of COVID survivors. More than 3 million of the 31 million Americans infected with COVID develop long-term symptoms, which can include fatigue, shortness of breath, depression, anxiety, and memory problems known as “brain fog.”

The new study also found many patients have significant muscle and bone pain.

The frequent use of opioids was surprising, given concerns about their potential for addiction, said Dr. Al-Aly, chief of research and education service at the VA St. Louis Health Care System.

“Physicians now are supposed to shy away from prescribing opioids,” said Dr. Al-Aly, who studied more than 73,000 patients in the VA system. When Dr. Al-Aly saw the number of opioids prescriptions, he said, he thought to himself: “Is this really happening all over again?”

Doctors need to act now, before “it’s too late to do something,” Dr. Al-Aly said. “We must act now and ensure that people are getting the care they need. We do not want this to balloon into a suicide crisis or another opioid epidemic.”

As more doctors became aware of their addictive potential, new opioid prescriptions fell, by more than half since 2012. But U.S. doctors still prescribe far more of the drugs – which include OxyContin, Vicodin, and codeine – than physicians in other countries, said Andrew Kolodny, MD, medical director of opioid policy research at Brandeis University, Waltham, Mass.

Some patients who became addicted to prescription painkillers switched to heroin, either because it was cheaper or because they could no longer obtain opioids from their doctors. Overdose deaths surged in recent years as drug dealers began spiking heroin with a powerful synthetic opioid called fentanyl.

More than 88,000 Americans died from overdoses during the 12 months ending in August 2020, according to the Centers for Disease Control and Prevention. Health experts now advise doctors to avoid prescribing opioids for long periods.

The new study “suggests to me that many clinicians still don’t get it,” Dr. Kolodny said. “Many clinicians are under the false impression that opioids are appropriate for chronic pain patients.”

Hospitalized COVID patients often receive a lot of medication to control pain and anxiety, especially in ICUs, said Greg Martin, MD, president of the Society of Critical Care Medicine. Patients placed on ventilators, for example, are often sedated to make them more comfortable.

Martin said he’s concerned by the study’s findings, which suggest patients are unnecessarily continuing medications after leaving the hospital.

“I worry that COVID-19 patients, especially those who are severely and critically ill, receive a lot of medications during the hospitalization, and because they have persistent symptoms, the medications are continued after hospital discharge,” Dr. Martin said.

While some COVID patients are experiencing muscle and bone pain for the first time, others say the illness has intensified their preexisting pain.

Rachael Sunshine Burnett has suffered from chronic pain in her back and feet for 20 years, ever since an accident at a warehouse where she once worked. But Ms. Burnett, who first was diagnosed with COVID in April 2020, said the pain soon became 10 times worse and spread to the area between her shoulders and spine. Although she was already taking long-acting OxyContin twice a day, her doctor prescribed an additional opioid called oxycodone, which relieves pain immediately. She was reinfected with COVID in December.

“It’s been a horrible, horrible year,” said Ms. Burnett, 43, of Coxsackie, N.Y.

Doctors should recognize that pain can be a part of long COVID, Dr. Martin said. “We need to find the proper nonnarcotic treatment for it, just like we do with other forms of chronic pain,” he said.

The CDC recommends a number of alternatives to opioids – from physical therapy to biofeedback, over-the-counter anti-inflammatories, antidepressants, and antiseizure drugs that also relieve nerve pain.

The country also needs an overall strategy to cope with the wave of post-COVID complications, Dr. Al-Aly said.

“It’s better to be prepared than to be caught off guard years from now, when doctors realize: ‘Oh, we have a resurgence in opioids,’ ” Dr. Al-Aly said.

Dr. Al-Aly noted that his study may not capture the full complexity of post-COVID patient needs. Although women make up the majority of long-COVID patients in most studies, most patients in the VA system are men.

The study of VA patients makes it “abundantly clear that we are not prepared to meet the needs of 3 million Americans with long COVID,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute in San Diego. “We desperately need an intervention that will effectively treat these individuals.”

Dr. Al-Aly said COVID survivors may need care for years.

“That’s going to be a huge, significant burden on the health care system,” Dr. Al-Aly said. “Long COVID will reverberate in the health system for years or even decades to come.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

COVID-19 survivors are at risk from a possible second pandemic, this time of opioid addiction, given the high rate of painkillers being prescribed to these patients, health experts say.

sdominick/Getty Images

A new study in Nature found alarmingly high rates of opioid use among COVID survivors with lingering symptoms at Veterans Affairs facilities. About 10% of COVID survivors develop “long COVID,” struggling with often disabling health problems even 6 months or longer after a diagnosis.

For every 1,000 long-COVID patients, known as “long-haulers,” who were treated at a VA facility, doctors wrote nine more prescriptions for opioids than they otherwise would have, along with 22 additional prescriptions for benzodiazepines, which include Xanax and other addictive pills used to treat anxiety.

Although previous studies have found many COVID survivors experience persistent health problems, the new article is the first to show they’re using more addictive medications, said Ziyad Al-Aly, MD, the paper’s lead author.

He’s concerned that even an apparently small increase in the inappropriate use of addictive pain pills will lead to a resurgence of the prescription opioid crisis, given the large number of COVID survivors. More than 3 million of the 31 million Americans infected with COVID develop long-term symptoms, which can include fatigue, shortness of breath, depression, anxiety, and memory problems known as “brain fog.”

The new study also found many patients have significant muscle and bone pain.

The frequent use of opioids was surprising, given concerns about their potential for addiction, said Dr. Al-Aly, chief of research and education service at the VA St. Louis Health Care System.

“Physicians now are supposed to shy away from prescribing opioids,” said Dr. Al-Aly, who studied more than 73,000 patients in the VA system. When Dr. Al-Aly saw the number of opioids prescriptions, he said, he thought to himself: “Is this really happening all over again?”

Doctors need to act now, before “it’s too late to do something,” Dr. Al-Aly said. “We must act now and ensure that people are getting the care they need. We do not want this to balloon into a suicide crisis or another opioid epidemic.”

As more doctors became aware of their addictive potential, new opioid prescriptions fell, by more than half since 2012. But U.S. doctors still prescribe far more of the drugs – which include OxyContin, Vicodin, and codeine – than physicians in other countries, said Andrew Kolodny, MD, medical director of opioid policy research at Brandeis University, Waltham, Mass.

Some patients who became addicted to prescription painkillers switched to heroin, either because it was cheaper or because they could no longer obtain opioids from their doctors. Overdose deaths surged in recent years as drug dealers began spiking heroin with a powerful synthetic opioid called fentanyl.

More than 88,000 Americans died from overdoses during the 12 months ending in August 2020, according to the Centers for Disease Control and Prevention. Health experts now advise doctors to avoid prescribing opioids for long periods.

The new study “suggests to me that many clinicians still don’t get it,” Dr. Kolodny said. “Many clinicians are under the false impression that opioids are appropriate for chronic pain patients.”

Hospitalized COVID patients often receive a lot of medication to control pain and anxiety, especially in ICUs, said Greg Martin, MD, president of the Society of Critical Care Medicine. Patients placed on ventilators, for example, are often sedated to make them more comfortable.

Martin said he’s concerned by the study’s findings, which suggest patients are unnecessarily continuing medications after leaving the hospital.

“I worry that COVID-19 patients, especially those who are severely and critically ill, receive a lot of medications during the hospitalization, and because they have persistent symptoms, the medications are continued after hospital discharge,” Dr. Martin said.

While some COVID patients are experiencing muscle and bone pain for the first time, others say the illness has intensified their preexisting pain.

Rachael Sunshine Burnett has suffered from chronic pain in her back and feet for 20 years, ever since an accident at a warehouse where she once worked. But Ms. Burnett, who first was diagnosed with COVID in April 2020, said the pain soon became 10 times worse and spread to the area between her shoulders and spine. Although she was already taking long-acting OxyContin twice a day, her doctor prescribed an additional opioid called oxycodone, which relieves pain immediately. She was reinfected with COVID in December.

“It’s been a horrible, horrible year,” said Ms. Burnett, 43, of Coxsackie, N.Y.

Doctors should recognize that pain can be a part of long COVID, Dr. Martin said. “We need to find the proper nonnarcotic treatment for it, just like we do with other forms of chronic pain,” he said.

The CDC recommends a number of alternatives to opioids – from physical therapy to biofeedback, over-the-counter anti-inflammatories, antidepressants, and antiseizure drugs that also relieve nerve pain.

The country also needs an overall strategy to cope with the wave of post-COVID complications, Dr. Al-Aly said.

“It’s better to be prepared than to be caught off guard years from now, when doctors realize: ‘Oh, we have a resurgence in opioids,’ ” Dr. Al-Aly said.

Dr. Al-Aly noted that his study may not capture the full complexity of post-COVID patient needs. Although women make up the majority of long-COVID patients in most studies, most patients in the VA system are men.

The study of VA patients makes it “abundantly clear that we are not prepared to meet the needs of 3 million Americans with long COVID,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute in San Diego. “We desperately need an intervention that will effectively treat these individuals.”

Dr. Al-Aly said COVID survivors may need care for years.

“That’s going to be a huge, significant burden on the health care system,” Dr. Al-Aly said. “Long COVID will reverberate in the health system for years or even decades to come.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

COVID-19 survivors are at risk from a possible second pandemic, this time of opioid addiction, given the high rate of painkillers being prescribed to these patients, health experts say.

sdominick/Getty Images

A new study in Nature found alarmingly high rates of opioid use among COVID survivors with lingering symptoms at Veterans Affairs facilities. About 10% of COVID survivors develop “long COVID,” struggling with often disabling health problems even 6 months or longer after a diagnosis.

For every 1,000 long-COVID patients, known as “long-haulers,” who were treated at a VA facility, doctors wrote nine more prescriptions for opioids than they otherwise would have, along with 22 additional prescriptions for benzodiazepines, which include Xanax and other addictive pills used to treat anxiety.

Although previous studies have found many COVID survivors experience persistent health problems, the new article is the first to show they’re using more addictive medications, said Ziyad Al-Aly, MD, the paper’s lead author.

He’s concerned that even an apparently small increase in the inappropriate use of addictive pain pills will lead to a resurgence of the prescription opioid crisis, given the large number of COVID survivors. More than 3 million of the 31 million Americans infected with COVID develop long-term symptoms, which can include fatigue, shortness of breath, depression, anxiety, and memory problems known as “brain fog.”

The new study also found many patients have significant muscle and bone pain.

The frequent use of opioids was surprising, given concerns about their potential for addiction, said Dr. Al-Aly, chief of research and education service at the VA St. Louis Health Care System.

“Physicians now are supposed to shy away from prescribing opioids,” said Dr. Al-Aly, who studied more than 73,000 patients in the VA system. When Dr. Al-Aly saw the number of opioids prescriptions, he said, he thought to himself: “Is this really happening all over again?”

Doctors need to act now, before “it’s too late to do something,” Dr. Al-Aly said. “We must act now and ensure that people are getting the care they need. We do not want this to balloon into a suicide crisis or another opioid epidemic.”

As more doctors became aware of their addictive potential, new opioid prescriptions fell, by more than half since 2012. But U.S. doctors still prescribe far more of the drugs – which include OxyContin, Vicodin, and codeine – than physicians in other countries, said Andrew Kolodny, MD, medical director of opioid policy research at Brandeis University, Waltham, Mass.

Some patients who became addicted to prescription painkillers switched to heroin, either because it was cheaper or because they could no longer obtain opioids from their doctors. Overdose deaths surged in recent years as drug dealers began spiking heroin with a powerful synthetic opioid called fentanyl.

More than 88,000 Americans died from overdoses during the 12 months ending in August 2020, according to the Centers for Disease Control and Prevention. Health experts now advise doctors to avoid prescribing opioids for long periods.

The new study “suggests to me that many clinicians still don’t get it,” Dr. Kolodny said. “Many clinicians are under the false impression that opioids are appropriate for chronic pain patients.”

Hospitalized COVID patients often receive a lot of medication to control pain and anxiety, especially in ICUs, said Greg Martin, MD, president of the Society of Critical Care Medicine. Patients placed on ventilators, for example, are often sedated to make them more comfortable.

Martin said he’s concerned by the study’s findings, which suggest patients are unnecessarily continuing medications after leaving the hospital.

“I worry that COVID-19 patients, especially those who are severely and critically ill, receive a lot of medications during the hospitalization, and because they have persistent symptoms, the medications are continued after hospital discharge,” Dr. Martin said.

While some COVID patients are experiencing muscle and bone pain for the first time, others say the illness has intensified their preexisting pain.

Rachael Sunshine Burnett has suffered from chronic pain in her back and feet for 20 years, ever since an accident at a warehouse where she once worked. But Ms. Burnett, who first was diagnosed with COVID in April 2020, said the pain soon became 10 times worse and spread to the area between her shoulders and spine. Although she was already taking long-acting OxyContin twice a day, her doctor prescribed an additional opioid called oxycodone, which relieves pain immediately. She was reinfected with COVID in December.

“It’s been a horrible, horrible year,” said Ms. Burnett, 43, of Coxsackie, N.Y.

Doctors should recognize that pain can be a part of long COVID, Dr. Martin said. “We need to find the proper nonnarcotic treatment for it, just like we do with other forms of chronic pain,” he said.

The CDC recommends a number of alternatives to opioids – from physical therapy to biofeedback, over-the-counter anti-inflammatories, antidepressants, and antiseizure drugs that also relieve nerve pain.

The country also needs an overall strategy to cope with the wave of post-COVID complications, Dr. Al-Aly said.

“It’s better to be prepared than to be caught off guard years from now, when doctors realize: ‘Oh, we have a resurgence in opioids,’ ” Dr. Al-Aly said.

Dr. Al-Aly noted that his study may not capture the full complexity of post-COVID patient needs. Although women make up the majority of long-COVID patients in most studies, most patients in the VA system are men.

The study of VA patients makes it “abundantly clear that we are not prepared to meet the needs of 3 million Americans with long COVID,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute in San Diego. “We desperately need an intervention that will effectively treat these individuals.”

Dr. Al-Aly said COVID survivors may need care for years.

“That’s going to be a huge, significant burden on the health care system,” Dr. Al-Aly said. “Long COVID will reverberate in the health system for years or even decades to come.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.

In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.

“They should be coming out very shortly,” Dr. Brooks said.

The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.

For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.

National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.

“I can’t overstate how serious this issue is for the health of our nation,” he said.

Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.

“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.

Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.

“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”

Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.

“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
 

Patients testify

Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.

Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”

Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.

“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”

She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.

“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”

Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.

“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.

In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.

“They should be coming out very shortly,” Dr. Brooks said.

The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.

For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.

National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.

“I can’t overstate how serious this issue is for the health of our nation,” he said.

Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.

“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.

Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.

“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”

Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.

“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
 

Patients testify

Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.

Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”

Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.

“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”

She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.

“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”

Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.

“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.

In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.

“They should be coming out very shortly,” Dr. Brooks said.

The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.

For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.

National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.

“I can’t overstate how serious this issue is for the health of our nation,” he said.

Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.

“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.

Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.

“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”

Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.

“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
 

Patients testify

Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.

Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”

Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.

“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”

She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.

“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”

Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.

“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”

A version of this article first appeared on Medscape.com.

Two more cancer indications that had been granted accelerated approval by the Food and Drug Administration are going to stay in place, at least for now. This was the verdict after the second day of a historic 3-day meeting (April 27-29) and follows a similar verdict from day 1.

Federal advisers so far have supported the idea of maintaining conditional approvals of some cancer indications for a number of immune checkpoint inhibitors, despite poor results in studies that were meant to confirm the benefit of these medicines for certain patients.

On the second day (April 28) of the FDA meeting, the Oncologic Drugs Advisory Committee (ODAC) supported the views of pharmaceutical companies in two more cases of what top agency staff call “dangling accelerated approvals.”

ODAC voted 10-1 in favor of maintaining the indication for atezolizumab (Tecentriq) for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.

ODAC also voted 5-3 that day in favor of maintaining accelerated approval for pembrolizumab (Keytruda) for first-line cisplatin- and carboplatin-ineligible patients with advanced/metastatic urothelial carcinoma.

The FDA often follows the advice of its panels, but it is not bound to do so. If the FDA were to decide to strip the indications in question from these PD-1 medicines, such decisions would not remove these drugs from the market. The three drugs have already been approved for a number of other cancer indications.

Off-label prescribing is not uncommon in oncology, but a loss of an approved indication would affect reimbursement for these medicines, Scot Ebbinghaus, MD, vice president of oncology clinical research at Merck (the manufacturer of pembrolizumab), told ODAC members during a discussion of the possible consequences of removing the indications in question.

“Access to those treatments may end up being substantially limited, and really the best way to ensure that there’s access is to maintain FDA approval,” Dr. Ebbinghaus said.

Another participant at the meeting asked the panel and the FDA to consider the burden on patients in paying for medicines that have not yet proved to be beneficial.

Diana Zuckerman, PhD, of the nonprofit National Center for Health Research, noted that the ODAC panel included physicians who see cancer patients.

“You’re used to trying different types of treatments in hopes that something will work,” she said. “Shouldn’t cancer patients be eligible for free treatment in clinical trials instead of paying for treatment that isn’t proven to work?”

Rapid development of PD-1 drugs

Top officials at the FDA framed the challenges with accelerated approvals for immunotherapy drugs in an April 21 article in The New England Journal of Medicine. Over the course of about 6 years, the FDA approved six of these PD-1 or PD-L1 drugs for more than 75 indications in oncology, wrote Richard Pazdur, MD, and Julia A. Beaver, MD, of the FDA.

“Development of drugs in this class occurred more rapidly than that in any other therapeutic area in history,” they wrote.

In 10 cases, the required follow-up trials did not confirm the expected benefit, and yet marketing authorization for these drugs continued, leading Dr. Pazdur and Dr. Beaver to dub these “dangling” accelerated approvals. Four of these indications were voluntarily withdrawn. For the other six indications, the FDA sought feedback from ODAC during the 3-day meeting. Over the first 2 days of the meeting, ODAC recommended that three of these cancer indications remain. Three more will be considered on the last day of the meeting.

A version of this article first appeared on Medscape.com.

Two more cancer indications that had been granted accelerated approval by the Food and Drug Administration are going to stay in place, at least for now. This was the verdict after the second day of a historic 3-day meeting (April 27-29) and follows a similar verdict from day 1.

Federal advisers so far have supported the idea of maintaining conditional approvals of some cancer indications for a number of immune checkpoint inhibitors, despite poor results in studies that were meant to confirm the benefit of these medicines for certain patients.

On the second day (April 28) of the FDA meeting, the Oncologic Drugs Advisory Committee (ODAC) supported the views of pharmaceutical companies in two more cases of what top agency staff call “dangling accelerated approvals.”

ODAC voted 10-1 in favor of maintaining the indication for atezolizumab (Tecentriq) for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.

ODAC also voted 5-3 that day in favor of maintaining accelerated approval for pembrolizumab (Keytruda) for first-line cisplatin- and carboplatin-ineligible patients with advanced/metastatic urothelial carcinoma.

The FDA often follows the advice of its panels, but it is not bound to do so. If the FDA were to decide to strip the indications in question from these PD-1 medicines, such decisions would not remove these drugs from the market. The three drugs have already been approved for a number of other cancer indications.

Off-label prescribing is not uncommon in oncology, but a loss of an approved indication would affect reimbursement for these medicines, Scot Ebbinghaus, MD, vice president of oncology clinical research at Merck (the manufacturer of pembrolizumab), told ODAC members during a discussion of the possible consequences of removing the indications in question.

“Access to those treatments may end up being substantially limited, and really the best way to ensure that there’s access is to maintain FDA approval,” Dr. Ebbinghaus said.

Another participant at the meeting asked the panel and the FDA to consider the burden on patients in paying for medicines that have not yet proved to be beneficial.

Diana Zuckerman, PhD, of the nonprofit National Center for Health Research, noted that the ODAC panel included physicians who see cancer patients.

“You’re used to trying different types of treatments in hopes that something will work,” she said. “Shouldn’t cancer patients be eligible for free treatment in clinical trials instead of paying for treatment that isn’t proven to work?”

Rapid development of PD-1 drugs

Top officials at the FDA framed the challenges with accelerated approvals for immunotherapy drugs in an April 21 article in The New England Journal of Medicine. Over the course of about 6 years, the FDA approved six of these PD-1 or PD-L1 drugs for more than 75 indications in oncology, wrote Richard Pazdur, MD, and Julia A. Beaver, MD, of the FDA.

“Development of drugs in this class occurred more rapidly than that in any other therapeutic area in history,” they wrote.

In 10 cases, the required follow-up trials did not confirm the expected benefit, and yet marketing authorization for these drugs continued, leading Dr. Pazdur and Dr. Beaver to dub these “dangling” accelerated approvals. Four of these indications were voluntarily withdrawn. For the other six indications, the FDA sought feedback from ODAC during the 3-day meeting. Over the first 2 days of the meeting, ODAC recommended that three of these cancer indications remain. Three more will be considered on the last day of the meeting.

A version of this article first appeared on Medscape.com.