Experiencing cyberbullying as a victim was a significant risk factor for suicidality in early adolescents aged 10-13 years, based on data from more than 10,000 individuals.

Adolescent suicidality, defined as suicidal ideation or suicide attempts, remains a major public health issue, Shay Arnon, MA, of Reichman University, Herzliya, Israel, and colleagues wrote.

Although cyberbullying experiences and perpetration have been associated with mental health issues, their roles as specific suicidality risk factors have not been explored, they said.

In a study published in JAMA Network Open, the researchers analyzed data on cyberbullying experiences collected between July 2018 and January 2021 as part of the Adolescent Brain Cognitive Development (ABCD) study, with a diverse population of young adolescents aged 10-13 years.

The study population included 10,414 participants; the mean age was 12 years, 47.6% were female.

Overall, 7.6% of the participants had reported suicidality during the study period. A total of 930 (8.9%) reported experiencing cyberbullying as victims, and 96 (0.9%) reported perpetrating cyberbullying; 66 (69%) of the perpetrators also experienced cyberbullying.

Experiencing cyberbullying was associated with a fourfold increased risk of suicidality (odds ratio, 4.2), that remained significant after controlling for factors including demographics and multiple environmental risk and protective factors, including negative life events, family conflict, parental monitoring, school environment, and racial/ethnic discrimination (OR, 2.5), and after controlling for internalizing and externalizing psychopathology (OR, 1.8).

Adolescents who were both target and perpetrator of offline peer aggression had an increased risk of suicidality (OR, 1.5 for both), and cyberbullying experiences also remained associated with suicidality when included with offline bullying as target and perpetrator (OR, 1.7).

The results contradict previous studies showing an increased risk of suicidality in cyberbullying perpetrators as well as victims, the researchers noted. Some possible reasons for this difference are the anonymity of many cyberbullying perpetrators, and the tendency of many adolescents on social media to make quick-turn comments without thinking of their actions as offensive to others.

The study findings were limited by several factors including the cross-sectional design, which prevented conclusions about causality, a low-resolution screening for cyberbullying experiences, and the effect of unmeasured confounding variables, the researchers noted. Other limitations include the collection of data before the COVID-19 pandemic, so the effects of the pandemic on peer online communication and cyberbullying could not be determined.

However, the results suggest that experiencing cyberbullying is significantly associated with suicidality in young adolescents independent of other peer aggression experiences. “Assessment of cyberbullying experiences among children and adolescents should be a component of the comprehensive suicide risk assessment,” they concluded.
 

Pandemic pushed existing cyberbullying problems

“Electronic media use has increased significantly in the early adolescent demographic, particularly during the COVID-19 pandemic,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview.

“In many cases, the majority of an adolescent’s peer-peer interactions are now occurring on electronic devices. This has dramatically increased the incidence and prevalence of cyberbullying, making this study very timely and relevant,” said Dr. Loper, who was not involved in the study.

“From an experiential, ethnographic standpoint working on a psychiatric acute crisis stabilization unit, we have consistently recognized cyberbullying as a common and frequent etiology of suicidal ideation or attempt in the adolescents admitted to our unit,” said Dr. Loper. 

“Unfortunately, much of the peer-peer interactions vital to supporting healthy adolescent development are now occurring on electronic devices instead of real-time and in person,” said Dr. Loper. “This comes with great risk to our adolescents and makes them susceptible to multiple potential dangers, not the least of which is cyberbullying.

“The biggest challenge in mitigating the impact of cyberbullying is that most adolescences want to have access to electronic media,” he said. “Limiting adolescents’ access to electronic media, and monitoring adolescents’ electronic media use are vital steps to preventing cyberbullying. Apps such as ‘Bark’ can used by parents to monitor their adolescents’ electronic media activity to ensure their safety and well-being.”

Additional research is needed to focus on other areas in which electronic media use may be affecting adolescents’ social, emotional, and psychological well-being and development, “which will become more and more important as electronic media use in this demographic continues to increase,” Dr. Loper said.

The study was supported by the National Institute of Mental Health and the Lifespan Brain Institute of Children’s Hospital of Philadelphia and Penn Medicine, University of Pennsylvania. The researchers had no financial conflicts to disclose. Dr. Loper had no financial conflicts to disclose.

Experiencing cyberbullying as a victim was a significant risk factor for suicidality in early adolescents aged 10-13 years, based on data from more than 10,000 individuals.

Adolescent suicidality, defined as suicidal ideation or suicide attempts, remains a major public health issue, Shay Arnon, MA, of Reichman University, Herzliya, Israel, and colleagues wrote.

Although cyberbullying experiences and perpetration have been associated with mental health issues, their roles as specific suicidality risk factors have not been explored, they said.

In a study published in JAMA Network Open, the researchers analyzed data on cyberbullying experiences collected between July 2018 and January 2021 as part of the Adolescent Brain Cognitive Development (ABCD) study, with a diverse population of young adolescents aged 10-13 years.

The study population included 10,414 participants; the mean age was 12 years, 47.6% were female.

Overall, 7.6% of the participants had reported suicidality during the study period. A total of 930 (8.9%) reported experiencing cyberbullying as victims, and 96 (0.9%) reported perpetrating cyberbullying; 66 (69%) of the perpetrators also experienced cyberbullying.

Experiencing cyberbullying was associated with a fourfold increased risk of suicidality (odds ratio, 4.2), that remained significant after controlling for factors including demographics and multiple environmental risk and protective factors, including negative life events, family conflict, parental monitoring, school environment, and racial/ethnic discrimination (OR, 2.5), and after controlling for internalizing and externalizing psychopathology (OR, 1.8).

Adolescents who were both target and perpetrator of offline peer aggression had an increased risk of suicidality (OR, 1.5 for both), and cyberbullying experiences also remained associated with suicidality when included with offline bullying as target and perpetrator (OR, 1.7).

The results contradict previous studies showing an increased risk of suicidality in cyberbullying perpetrators as well as victims, the researchers noted. Some possible reasons for this difference are the anonymity of many cyberbullying perpetrators, and the tendency of many adolescents on social media to make quick-turn comments without thinking of their actions as offensive to others.

The study findings were limited by several factors including the cross-sectional design, which prevented conclusions about causality, a low-resolution screening for cyberbullying experiences, and the effect of unmeasured confounding variables, the researchers noted. Other limitations include the collection of data before the COVID-19 pandemic, so the effects of the pandemic on peer online communication and cyberbullying could not be determined.

However, the results suggest that experiencing cyberbullying is significantly associated with suicidality in young adolescents independent of other peer aggression experiences. “Assessment of cyberbullying experiences among children and adolescents should be a component of the comprehensive suicide risk assessment,” they concluded.
 

Pandemic pushed existing cyberbullying problems

“Electronic media use has increased significantly in the early adolescent demographic, particularly during the COVID-19 pandemic,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview.

“In many cases, the majority of an adolescent’s peer-peer interactions are now occurring on electronic devices. This has dramatically increased the incidence and prevalence of cyberbullying, making this study very timely and relevant,” said Dr. Loper, who was not involved in the study.

“From an experiential, ethnographic standpoint working on a psychiatric acute crisis stabilization unit, we have consistently recognized cyberbullying as a common and frequent etiology of suicidal ideation or attempt in the adolescents admitted to our unit,” said Dr. Loper. 

“Unfortunately, much of the peer-peer interactions vital to supporting healthy adolescent development are now occurring on electronic devices instead of real-time and in person,” said Dr. Loper. “This comes with great risk to our adolescents and makes them susceptible to multiple potential dangers, not the least of which is cyberbullying.

“The biggest challenge in mitigating the impact of cyberbullying is that most adolescences want to have access to electronic media,” he said. “Limiting adolescents’ access to electronic media, and monitoring adolescents’ electronic media use are vital steps to preventing cyberbullying. Apps such as ‘Bark’ can used by parents to monitor their adolescents’ electronic media activity to ensure their safety and well-being.”

Additional research is needed to focus on other areas in which electronic media use may be affecting adolescents’ social, emotional, and psychological well-being and development, “which will become more and more important as electronic media use in this demographic continues to increase,” Dr. Loper said.

The study was supported by the National Institute of Mental Health and the Lifespan Brain Institute of Children’s Hospital of Philadelphia and Penn Medicine, University of Pennsylvania. The researchers had no financial conflicts to disclose. Dr. Loper had no financial conflicts to disclose.

Experiencing cyberbullying as a victim was a significant risk factor for suicidality in early adolescents aged 10-13 years, based on data from more than 10,000 individuals.

Adolescent suicidality, defined as suicidal ideation or suicide attempts, remains a major public health issue, Shay Arnon, MA, of Reichman University, Herzliya, Israel, and colleagues wrote.

Although cyberbullying experiences and perpetration have been associated with mental health issues, their roles as specific suicidality risk factors have not been explored, they said.

In a study published in JAMA Network Open, the researchers analyzed data on cyberbullying experiences collected between July 2018 and January 2021 as part of the Adolescent Brain Cognitive Development (ABCD) study, with a diverse population of young adolescents aged 10-13 years.

The study population included 10,414 participants; the mean age was 12 years, 47.6% were female.

Overall, 7.6% of the participants had reported suicidality during the study period. A total of 930 (8.9%) reported experiencing cyberbullying as victims, and 96 (0.9%) reported perpetrating cyberbullying; 66 (69%) of the perpetrators also experienced cyberbullying.

Experiencing cyberbullying was associated with a fourfold increased risk of suicidality (odds ratio, 4.2), that remained significant after controlling for factors including demographics and multiple environmental risk and protective factors, including negative life events, family conflict, parental monitoring, school environment, and racial/ethnic discrimination (OR, 2.5), and after controlling for internalizing and externalizing psychopathology (OR, 1.8).

Adolescents who were both target and perpetrator of offline peer aggression had an increased risk of suicidality (OR, 1.5 for both), and cyberbullying experiences also remained associated with suicidality when included with offline bullying as target and perpetrator (OR, 1.7).

The results contradict previous studies showing an increased risk of suicidality in cyberbullying perpetrators as well as victims, the researchers noted. Some possible reasons for this difference are the anonymity of many cyberbullying perpetrators, and the tendency of many adolescents on social media to make quick-turn comments without thinking of their actions as offensive to others.

The study findings were limited by several factors including the cross-sectional design, which prevented conclusions about causality, a low-resolution screening for cyberbullying experiences, and the effect of unmeasured confounding variables, the researchers noted. Other limitations include the collection of data before the COVID-19 pandemic, so the effects of the pandemic on peer online communication and cyberbullying could not be determined.

However, the results suggest that experiencing cyberbullying is significantly associated with suicidality in young adolescents independent of other peer aggression experiences. “Assessment of cyberbullying experiences among children and adolescents should be a component of the comprehensive suicide risk assessment,” they concluded.
 

Pandemic pushed existing cyberbullying problems

“Electronic media use has increased significantly in the early adolescent demographic, particularly during the COVID-19 pandemic,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview.

“In many cases, the majority of an adolescent’s peer-peer interactions are now occurring on electronic devices. This has dramatically increased the incidence and prevalence of cyberbullying, making this study very timely and relevant,” said Dr. Loper, who was not involved in the study.

“From an experiential, ethnographic standpoint working on a psychiatric acute crisis stabilization unit, we have consistently recognized cyberbullying as a common and frequent etiology of suicidal ideation or attempt in the adolescents admitted to our unit,” said Dr. Loper. 

“Unfortunately, much of the peer-peer interactions vital to supporting healthy adolescent development are now occurring on electronic devices instead of real-time and in person,” said Dr. Loper. “This comes with great risk to our adolescents and makes them susceptible to multiple potential dangers, not the least of which is cyberbullying.

“The biggest challenge in mitigating the impact of cyberbullying is that most adolescences want to have access to electronic media,” he said. “Limiting adolescents’ access to electronic media, and monitoring adolescents’ electronic media use are vital steps to preventing cyberbullying. Apps such as ‘Bark’ can used by parents to monitor their adolescents’ electronic media activity to ensure their safety and well-being.”

Additional research is needed to focus on other areas in which electronic media use may be affecting adolescents’ social, emotional, and psychological well-being and development, “which will become more and more important as electronic media use in this demographic continues to increase,” Dr. Loper said.

The study was supported by the National Institute of Mental Health and the Lifespan Brain Institute of Children’s Hospital of Philadelphia and Penn Medicine, University of Pennsylvania. The researchers had no financial conflicts to disclose. Dr. Loper had no financial conflicts to disclose.

A new study finds that mortality is significantly higher among patients with advanced solid tumors who are admitted to the hospital for chemotherapy treatment.

The findings – released in a poster session at the annual meeting of the American Society of Clinical Oncology – found that patients with solid tumors were more likely to be treated for nonurgent indications, not be referred to palliative care, and die within 60 days, compared with patients with hematologic malignancies.

Decisions about inpatient chemotherapy should not be uniform and instead should be based on a case-by-case basis, said Natalie Berger, MD, a hematologist-oncologist at Mount Sinai Hospital,, New York, and the study’s lead author.

Inpatient chemotherapy can be appropriate in certain situations, such as when chemotherapy must be given in the hospital and when it must be administered quickly after a patient presents with cancer symptoms and needs relief, she said.

However, “sometimes patients are admitted due to infection, side effects of chemotherapy or cancer, or for reasons unrelated to their cancer, and chemotherapy may be administered when it is not appropriate. It is also overutilized at the end of life which can lead to more aggressive end-of-life care rather than focusing on quality of life and supportive care,” Dr. Berger said.

The study is based on a retrospective chart review of 880 patients admitted to Mount Sinai Hospital between January 2016 and December 2017 to receive chemotherapy.

They found that the type of tumor was used to determine the urgency of an in-hospital stay for chemotherapy (odds ratio, 0.42; 95% CI, 0.25-0.72; P = .001). Patients with solid tumors or older patients or patients with a functional impairment score (Karnofsky Performance Scale) of 50% were less likely to respond to chemotherapy. There was also a decrease in quality of life among these patients, but only 46% of patients with solid tumors and 15% of patients with hematologic malignancies met with a palliative care professional.

One-third (34%) of patients with solid tumors didn’t have urgent indications, 43% of patients had no response to inpatient chemotherapy, and 20% died within 60 days, compared with patients with hematologic malignancies (19%, 19%, and 9%, respectively).

“There are many reasons why this [high mortality rate in patients with solid tumors] may be happening. Solid tumor patients are more often admitted at a later stage of their cancer when they are sicker, and they were also less likely to have a response to inpatient chemotherapy. Older patients and patients with a poor performance status were also less likely to respond to chemotherapy. This indicates that these patients were sicker, and chemotherapy use may not have been appropriate and palliative care may be underutilized,” she said.

Dr. Berger and colleagues have created a standardized protocol to assess “the appropriateness” of inpatient chemotherapy, improve quality of life, and reduce chemotherapy and health care utilization at the end of life. The protocol has been implemented as a pilot program at Mount Sinai Hospital, Dr. Berger said.

“Any inpatient chemotherapy case that meets standard accepted criteria for required inpatient administration are auto-approved through the electronic survey. For cases outside of standard criteria, further information must be inputted to determine appropriateness of inpatient treatment and are then scored electronically and reviewed by committee physicians and pharmacists,” she said.

Gabriel A. Brooks, MD, MPH, an oncologist with Dartmouth Hitchcock Medical Center, Lebanon, N.H., who was not affiliated with the study, said that inpatient chemotherapy treatment is under scrutiny elsewhere as well.

“There has been recognition that patients who are otherwise sick enough to require hospital admission are often too sick to benefit from chemotherapy,” although there are exceptions. “There is certainly a movement to limit inpatient chemotherapy to situations where it is most likely to be beneficial. Some of this is driven by cost pressures. For instance, Medicare pays for inpatient hospitalizations using the DRG [diagnosis-related group] system. Hospitals cannot charge a la carte for treatments given in the hospital. Instead, they are reimbursed at a fixed rate based on the hospital diagnoses. This will often lead to poor reimbursement of high-cost cancer treatments.”

Dr. Brooks said the study offers insight into who’s getting inpatient chemotherapy. However, “what I can’t tell from this poster is how often the solid tumor patients are getting first-line chemotherapy [as] these patients may be presenting late or may have a potentially treatable cancer with a narrow closing window for treatment versus later-line chemotherapy.”

He also noted that patient and family wishes are missing from the research. “This is critical. Patients and families should be informed that inpatient chemotherapy may not provide the benefit they are hoping for, especially for patients with solid tumors starting later lines of therapy. Patients should be informed that there are alternatives to inpatient chemotherapy, such as hospice referral or waiting for possible outpatient treatment – if their condition improves. But when a patient wants to try inpatient chemotherapy and their doctor wants to offer it, then it is likely a reasonable thing to try.”

Going forward, he said, “qualitative study is needed to better understand when and why inpatient chemotherapy is used. There are likely some clear good uses and some clear bad uses of inpatient chemotherapy. Can outpatient regimens be substituted for the regimens where patients are directly admitted? Or, can outpatient protocols be devised for these regimens? Are there specific situations where inpatient chemotherapy is the right thing (leukemia, esophageal cancer with worsening dysphagia, etc.)?”

No study funding was received.

A new study finds that mortality is significantly higher among patients with advanced solid tumors who are admitted to the hospital for chemotherapy treatment.

The findings – released in a poster session at the annual meeting of the American Society of Clinical Oncology – found that patients with solid tumors were more likely to be treated for nonurgent indications, not be referred to palliative care, and die within 60 days, compared with patients with hematologic malignancies.

Decisions about inpatient chemotherapy should not be uniform and instead should be based on a case-by-case basis, said Natalie Berger, MD, a hematologist-oncologist at Mount Sinai Hospital,, New York, and the study’s lead author.

Inpatient chemotherapy can be appropriate in certain situations, such as when chemotherapy must be given in the hospital and when it must be administered quickly after a patient presents with cancer symptoms and needs relief, she said.

However, “sometimes patients are admitted due to infection, side effects of chemotherapy or cancer, or for reasons unrelated to their cancer, and chemotherapy may be administered when it is not appropriate. It is also overutilized at the end of life which can lead to more aggressive end-of-life care rather than focusing on quality of life and supportive care,” Dr. Berger said.

The study is based on a retrospective chart review of 880 patients admitted to Mount Sinai Hospital between January 2016 and December 2017 to receive chemotherapy.

They found that the type of tumor was used to determine the urgency of an in-hospital stay for chemotherapy (odds ratio, 0.42; 95% CI, 0.25-0.72; P = .001). Patients with solid tumors or older patients or patients with a functional impairment score (Karnofsky Performance Scale) of 50% were less likely to respond to chemotherapy. There was also a decrease in quality of life among these patients, but only 46% of patients with solid tumors and 15% of patients with hematologic malignancies met with a palliative care professional.

One-third (34%) of patients with solid tumors didn’t have urgent indications, 43% of patients had no response to inpatient chemotherapy, and 20% died within 60 days, compared with patients with hematologic malignancies (19%, 19%, and 9%, respectively).

“There are many reasons why this [high mortality rate in patients with solid tumors] may be happening. Solid tumor patients are more often admitted at a later stage of their cancer when they are sicker, and they were also less likely to have a response to inpatient chemotherapy. Older patients and patients with a poor performance status were also less likely to respond to chemotherapy. This indicates that these patients were sicker, and chemotherapy use may not have been appropriate and palliative care may be underutilized,” she said.

Dr. Berger and colleagues have created a standardized protocol to assess “the appropriateness” of inpatient chemotherapy, improve quality of life, and reduce chemotherapy and health care utilization at the end of life. The protocol has been implemented as a pilot program at Mount Sinai Hospital, Dr. Berger said.

“Any inpatient chemotherapy case that meets standard accepted criteria for required inpatient administration are auto-approved through the electronic survey. For cases outside of standard criteria, further information must be inputted to determine appropriateness of inpatient treatment and are then scored electronically and reviewed by committee physicians and pharmacists,” she said.

Gabriel A. Brooks, MD, MPH, an oncologist with Dartmouth Hitchcock Medical Center, Lebanon, N.H., who was not affiliated with the study, said that inpatient chemotherapy treatment is under scrutiny elsewhere as well.

“There has been recognition that patients who are otherwise sick enough to require hospital admission are often too sick to benefit from chemotherapy,” although there are exceptions. “There is certainly a movement to limit inpatient chemotherapy to situations where it is most likely to be beneficial. Some of this is driven by cost pressures. For instance, Medicare pays for inpatient hospitalizations using the DRG [diagnosis-related group] system. Hospitals cannot charge a la carte for treatments given in the hospital. Instead, they are reimbursed at a fixed rate based on the hospital diagnoses. This will often lead to poor reimbursement of high-cost cancer treatments.”

Dr. Brooks said the study offers insight into who’s getting inpatient chemotherapy. However, “what I can’t tell from this poster is how often the solid tumor patients are getting first-line chemotherapy [as] these patients may be presenting late or may have a potentially treatable cancer with a narrow closing window for treatment versus later-line chemotherapy.”

He also noted that patient and family wishes are missing from the research. “This is critical. Patients and families should be informed that inpatient chemotherapy may not provide the benefit they are hoping for, especially for patients with solid tumors starting later lines of therapy. Patients should be informed that there are alternatives to inpatient chemotherapy, such as hospice referral or waiting for possible outpatient treatment – if their condition improves. But when a patient wants to try inpatient chemotherapy and their doctor wants to offer it, then it is likely a reasonable thing to try.”

Going forward, he said, “qualitative study is needed to better understand when and why inpatient chemotherapy is used. There are likely some clear good uses and some clear bad uses of inpatient chemotherapy. Can outpatient regimens be substituted for the regimens where patients are directly admitted? Or, can outpatient protocols be devised for these regimens? Are there specific situations where inpatient chemotherapy is the right thing (leukemia, esophageal cancer with worsening dysphagia, etc.)?”

No study funding was received.

A new study finds that mortality is significantly higher among patients with advanced solid tumors who are admitted to the hospital for chemotherapy treatment.

The findings – released in a poster session at the annual meeting of the American Society of Clinical Oncology – found that patients with solid tumors were more likely to be treated for nonurgent indications, not be referred to palliative care, and die within 60 days, compared with patients with hematologic malignancies.

Decisions about inpatient chemotherapy should not be uniform and instead should be based on a case-by-case basis, said Natalie Berger, MD, a hematologist-oncologist at Mount Sinai Hospital,, New York, and the study’s lead author.

Inpatient chemotherapy can be appropriate in certain situations, such as when chemotherapy must be given in the hospital and when it must be administered quickly after a patient presents with cancer symptoms and needs relief, she said.

However, “sometimes patients are admitted due to infection, side effects of chemotherapy or cancer, or for reasons unrelated to their cancer, and chemotherapy may be administered when it is not appropriate. It is also overutilized at the end of life which can lead to more aggressive end-of-life care rather than focusing on quality of life and supportive care,” Dr. Berger said.

The study is based on a retrospective chart review of 880 patients admitted to Mount Sinai Hospital between January 2016 and December 2017 to receive chemotherapy.

They found that the type of tumor was used to determine the urgency of an in-hospital stay for chemotherapy (odds ratio, 0.42; 95% CI, 0.25-0.72; P = .001). Patients with solid tumors or older patients or patients with a functional impairment score (Karnofsky Performance Scale) of 50% were less likely to respond to chemotherapy. There was also a decrease in quality of life among these patients, but only 46% of patients with solid tumors and 15% of patients with hematologic malignancies met with a palliative care professional.

One-third (34%) of patients with solid tumors didn’t have urgent indications, 43% of patients had no response to inpatient chemotherapy, and 20% died within 60 days, compared with patients with hematologic malignancies (19%, 19%, and 9%, respectively).

“There are many reasons why this [high mortality rate in patients with solid tumors] may be happening. Solid tumor patients are more often admitted at a later stage of their cancer when they are sicker, and they were also less likely to have a response to inpatient chemotherapy. Older patients and patients with a poor performance status were also less likely to respond to chemotherapy. This indicates that these patients were sicker, and chemotherapy use may not have been appropriate and palliative care may be underutilized,” she said.

Dr. Berger and colleagues have created a standardized protocol to assess “the appropriateness” of inpatient chemotherapy, improve quality of life, and reduce chemotherapy and health care utilization at the end of life. The protocol has been implemented as a pilot program at Mount Sinai Hospital, Dr. Berger said.

“Any inpatient chemotherapy case that meets standard accepted criteria for required inpatient administration are auto-approved through the electronic survey. For cases outside of standard criteria, further information must be inputted to determine appropriateness of inpatient treatment and are then scored electronically and reviewed by committee physicians and pharmacists,” she said.

Gabriel A. Brooks, MD, MPH, an oncologist with Dartmouth Hitchcock Medical Center, Lebanon, N.H., who was not affiliated with the study, said that inpatient chemotherapy treatment is under scrutiny elsewhere as well.

“There has been recognition that patients who are otherwise sick enough to require hospital admission are often too sick to benefit from chemotherapy,” although there are exceptions. “There is certainly a movement to limit inpatient chemotherapy to situations where it is most likely to be beneficial. Some of this is driven by cost pressures. For instance, Medicare pays for inpatient hospitalizations using the DRG [diagnosis-related group] system. Hospitals cannot charge a la carte for treatments given in the hospital. Instead, they are reimbursed at a fixed rate based on the hospital diagnoses. This will often lead to poor reimbursement of high-cost cancer treatments.”

Dr. Brooks said the study offers insight into who’s getting inpatient chemotherapy. However, “what I can’t tell from this poster is how often the solid tumor patients are getting first-line chemotherapy [as] these patients may be presenting late or may have a potentially treatable cancer with a narrow closing window for treatment versus later-line chemotherapy.”

He also noted that patient and family wishes are missing from the research. “This is critical. Patients and families should be informed that inpatient chemotherapy may not provide the benefit they are hoping for, especially for patients with solid tumors starting later lines of therapy. Patients should be informed that there are alternatives to inpatient chemotherapy, such as hospice referral or waiting for possible outpatient treatment – if their condition improves. But when a patient wants to try inpatient chemotherapy and their doctor wants to offer it, then it is likely a reasonable thing to try.”

Going forward, he said, “qualitative study is needed to better understand when and why inpatient chemotherapy is used. There are likely some clear good uses and some clear bad uses of inpatient chemotherapy. Can outpatient regimens be substituted for the regimens where patients are directly admitted? Or, can outpatient protocols be devised for these regimens? Are there specific situations where inpatient chemotherapy is the right thing (leukemia, esophageal cancer with worsening dysphagia, etc.)?”

No study funding was received.

Boys with obesity have lower testicular volume, compared with their normal-weight counterparts, suggesting the potential for fertility problems in adulthood, new data suggest.

Testicular volume is a fertility marker directly related to sperm count that has halved in the past 40 years worldwide for unknown reasons. At the same time, childhood obesity has risen dramatically and infertility appears to have risen as well, Rossella Cannarella, MD, of the department of endocrinology and andrology, University of Catania (Italy), said at the annual meeting of the Endocrine Society.

According to recent Italian studies, between 14% and 23% of young men aged 18-19 had testicular hypotrophy. “Worryingly, we don’t know the reason for this hypotrophy. And therefore, they are at risk for future infertility,” Dr. Cannarella said during a press briefing.

Her study, which included a total of 264 male children and adolescents, also linked lower testicular volume to hyperinsulinemia and insulin resistance. “The testis is not quiescent in childhood and is sensitive to the hormone insulin. Obesity and metabolic impairment actually can have an effect and negative impact on Sertoli cell proliferation,” Dr. Cannarella said.
 

Screen testicular volume at all visits

If other studies confirm these results, she said that pediatricians should begin routinely assessing testicular volume at all visits as is now done with height and weight to identify early deflection of the testicular growth curve.

In addition, “include male infertility as a possible consequence of obesity in counseling of male obese children,” she advised.

Asked to comment, Amin Sedaghat Herati, MD, director of male infertility and men’s health at Johns Hopkins Hospital, and assistant professor of urology at Johns Hopkins Medicine, both in Baltimore, said in an interview: “I think what’s really interesting about this study is the association that they’ve made between testicular volume and obesity.”

But, he noted, “it does not implicate necessarily the development of infertility. It’s an extrapolation. So it’s a step towards the link between obesity and infertility, and it’s an important study to establish the association, but changes in testicular volume and even changes in semen panel don’t necessarily indicate fertility or infertility.”

The findings are “consistent with what we know as far as what obesity can potentially do to the activity of the cells in the testes. The authors are postulating that it’s more the support cells, called Sertoli cells, but I would say it’s probably all of the cells that are being affected by obesity and specifically elevated leptin levels,” Dr. Herati said.

He agrees with the recommendation that pediatricians screen all boys for testicular volume. “I agree it’s a good idea so they don’t miss any cases in which the testes don’t develop the way they should or any other conditions,” Dr. Herati said. “I think in general it’s a good practice, especially in the peripubertal stage, to make sure that kids are on the same growth curve and that they’re meeting their Tanner staging. [Pediatricians] should be looking at the size of the testes and tracking, maybe not at every visit, but at least on an annual basis.”

And, he noted, “I think any study that establishes a link that we can point to when we’re educating patients and parents is important.”
 

Links found between overweight/obesity, testicular hypotrophy

The study population included 61 male children and adolescents with normal weight, 53 with overweight, and 150 with obesity. Insulin resistance (Homeostatic Model Assessment for Insulin Resistance index ≥ 2.5) was present in 97 participants, 22 had prediabetes, and 3 had type 2 diabetes. Clinical data were collected retrospectively.

Among the boys aged 9-14 years, those with overweight and obesity had significantly lower testicular volume, compared with those of normal weight.

Those who were in Tanner Stage 1 were more likely to have overweight and obesity than those with normal weight, suggesting that “overweight and obese adolescents start puberty later than those of normal weight,” Dr. Cannarella said.

In the 14- to 16-year-old age group, those with insulin resistance had lower testicular volume, compared with those without insulin resistance (HOMA index < 2.5). The number of insulin-resistant adolescents was greater than that of controls in the Tanner stage 2 group.

In both the prepubertal (< 9 years) and pubertal (14-16 years) groups, hyperinsulinemia was associated with lower levels of testicular volume.

Hyperinsulinemia did not influence the timing of puberty onset.
 

No way to quantify the effect of obesity on fertility just yet

During a press briefing, Dr. Cannarella commented that obesity is likely just one of several factors influencing what appears to be an increase in male infertility over time. “It isn’t of course the only reason, but many factors in our environment have drastically changed, compared to 40 years ago, including the prevalence of heavy metals and endocrine disruptors, and of course, the change in habits and higher prevalence of metabolic disease. All of this has an impact on the proliferation of Sertoli cells in childhood and this may explain the trend toward the decline of sperm concentration and count.”

Longitudinal data are needed to establish cause and effect, she noted. “We need longitudinal studies that link the degrees of testicular volume with the degree of the sperm concentration and count starting from childhood and ending with the adult age. This is the missing link so far.”

Dr. Cannarella has reported no relevant financial relationships. Dr. Herati has reported being an advisor for Dadi, LiNA Medical, and Teleflex.

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

Boys with obesity have lower testicular volume, compared with their normal-weight counterparts, suggesting the potential for fertility problems in adulthood, new data suggest.

Testicular volume is a fertility marker directly related to sperm count that has halved in the past 40 years worldwide for unknown reasons. At the same time, childhood obesity has risen dramatically and infertility appears to have risen as well, Rossella Cannarella, MD, of the department of endocrinology and andrology, University of Catania (Italy), said at the annual meeting of the Endocrine Society.

According to recent Italian studies, between 14% and 23% of young men aged 18-19 had testicular hypotrophy. “Worryingly, we don’t know the reason for this hypotrophy. And therefore, they are at risk for future infertility,” Dr. Cannarella said during a press briefing.

Her study, which included a total of 264 male children and adolescents, also linked lower testicular volume to hyperinsulinemia and insulin resistance. “The testis is not quiescent in childhood and is sensitive to the hormone insulin. Obesity and metabolic impairment actually can have an effect and negative impact on Sertoli cell proliferation,” Dr. Cannarella said.
 

Screen testicular volume at all visits

If other studies confirm these results, she said that pediatricians should begin routinely assessing testicular volume at all visits as is now done with height and weight to identify early deflection of the testicular growth curve.

In addition, “include male infertility as a possible consequence of obesity in counseling of male obese children,” she advised.

Asked to comment, Amin Sedaghat Herati, MD, director of male infertility and men’s health at Johns Hopkins Hospital, and assistant professor of urology at Johns Hopkins Medicine, both in Baltimore, said in an interview: “I think what’s really interesting about this study is the association that they’ve made between testicular volume and obesity.”

But, he noted, “it does not implicate necessarily the development of infertility. It’s an extrapolation. So it’s a step towards the link between obesity and infertility, and it’s an important study to establish the association, but changes in testicular volume and even changes in semen panel don’t necessarily indicate fertility or infertility.”

The findings are “consistent with what we know as far as what obesity can potentially do to the activity of the cells in the testes. The authors are postulating that it’s more the support cells, called Sertoli cells, but I would say it’s probably all of the cells that are being affected by obesity and specifically elevated leptin levels,” Dr. Herati said.

He agrees with the recommendation that pediatricians screen all boys for testicular volume. “I agree it’s a good idea so they don’t miss any cases in which the testes don’t develop the way they should or any other conditions,” Dr. Herati said. “I think in general it’s a good practice, especially in the peripubertal stage, to make sure that kids are on the same growth curve and that they’re meeting their Tanner staging. [Pediatricians] should be looking at the size of the testes and tracking, maybe not at every visit, but at least on an annual basis.”

And, he noted, “I think any study that establishes a link that we can point to when we’re educating patients and parents is important.”
 

Links found between overweight/obesity, testicular hypotrophy

The study population included 61 male children and adolescents with normal weight, 53 with overweight, and 150 with obesity. Insulin resistance (Homeostatic Model Assessment for Insulin Resistance index ≥ 2.5) was present in 97 participants, 22 had prediabetes, and 3 had type 2 diabetes. Clinical data were collected retrospectively.

Among the boys aged 9-14 years, those with overweight and obesity had significantly lower testicular volume, compared with those of normal weight.

Those who were in Tanner Stage 1 were more likely to have overweight and obesity than those with normal weight, suggesting that “overweight and obese adolescents start puberty later than those of normal weight,” Dr. Cannarella said.

In the 14- to 16-year-old age group, those with insulin resistance had lower testicular volume, compared with those without insulin resistance (HOMA index < 2.5). The number of insulin-resistant adolescents was greater than that of controls in the Tanner stage 2 group.

In both the prepubertal (< 9 years) and pubertal (14-16 years) groups, hyperinsulinemia was associated with lower levels of testicular volume.

Hyperinsulinemia did not influence the timing of puberty onset.
 

No way to quantify the effect of obesity on fertility just yet

During a press briefing, Dr. Cannarella commented that obesity is likely just one of several factors influencing what appears to be an increase in male infertility over time. “It isn’t of course the only reason, but many factors in our environment have drastically changed, compared to 40 years ago, including the prevalence of heavy metals and endocrine disruptors, and of course, the change in habits and higher prevalence of metabolic disease. All of this has an impact on the proliferation of Sertoli cells in childhood and this may explain the trend toward the decline of sperm concentration and count.”

Longitudinal data are needed to establish cause and effect, she noted. “We need longitudinal studies that link the degrees of testicular volume with the degree of the sperm concentration and count starting from childhood and ending with the adult age. This is the missing link so far.”

Dr. Cannarella has reported no relevant financial relationships. Dr. Herati has reported being an advisor for Dadi, LiNA Medical, and Teleflex.

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

Boys with obesity have lower testicular volume, compared with their normal-weight counterparts, suggesting the potential for fertility problems in adulthood, new data suggest.

Testicular volume is a fertility marker directly related to sperm count that has halved in the past 40 years worldwide for unknown reasons. At the same time, childhood obesity has risen dramatically and infertility appears to have risen as well, Rossella Cannarella, MD, of the department of endocrinology and andrology, University of Catania (Italy), said at the annual meeting of the Endocrine Society.

According to recent Italian studies, between 14% and 23% of young men aged 18-19 had testicular hypotrophy. “Worryingly, we don’t know the reason for this hypotrophy. And therefore, they are at risk for future infertility,” Dr. Cannarella said during a press briefing.

Her study, which included a total of 264 male children and adolescents, also linked lower testicular volume to hyperinsulinemia and insulin resistance. “The testis is not quiescent in childhood and is sensitive to the hormone insulin. Obesity and metabolic impairment actually can have an effect and negative impact on Sertoli cell proliferation,” Dr. Cannarella said.
 

Screen testicular volume at all visits

If other studies confirm these results, she said that pediatricians should begin routinely assessing testicular volume at all visits as is now done with height and weight to identify early deflection of the testicular growth curve.

In addition, “include male infertility as a possible consequence of obesity in counseling of male obese children,” she advised.

Asked to comment, Amin Sedaghat Herati, MD, director of male infertility and men’s health at Johns Hopkins Hospital, and assistant professor of urology at Johns Hopkins Medicine, both in Baltimore, said in an interview: “I think what’s really interesting about this study is the association that they’ve made between testicular volume and obesity.”

But, he noted, “it does not implicate necessarily the development of infertility. It’s an extrapolation. So it’s a step towards the link between obesity and infertility, and it’s an important study to establish the association, but changes in testicular volume and even changes in semen panel don’t necessarily indicate fertility or infertility.”

The findings are “consistent with what we know as far as what obesity can potentially do to the activity of the cells in the testes. The authors are postulating that it’s more the support cells, called Sertoli cells, but I would say it’s probably all of the cells that are being affected by obesity and specifically elevated leptin levels,” Dr. Herati said.

He agrees with the recommendation that pediatricians screen all boys for testicular volume. “I agree it’s a good idea so they don’t miss any cases in which the testes don’t develop the way they should or any other conditions,” Dr. Herati said. “I think in general it’s a good practice, especially in the peripubertal stage, to make sure that kids are on the same growth curve and that they’re meeting their Tanner staging. [Pediatricians] should be looking at the size of the testes and tracking, maybe not at every visit, but at least on an annual basis.”

And, he noted, “I think any study that establishes a link that we can point to when we’re educating patients and parents is important.”
 

Links found between overweight/obesity, testicular hypotrophy

The study population included 61 male children and adolescents with normal weight, 53 with overweight, and 150 with obesity. Insulin resistance (Homeostatic Model Assessment for Insulin Resistance index ≥ 2.5) was present in 97 participants, 22 had prediabetes, and 3 had type 2 diabetes. Clinical data were collected retrospectively.

Among the boys aged 9-14 years, those with overweight and obesity had significantly lower testicular volume, compared with those of normal weight.

Those who were in Tanner Stage 1 were more likely to have overweight and obesity than those with normal weight, suggesting that “overweight and obese adolescents start puberty later than those of normal weight,” Dr. Cannarella said.

In the 14- to 16-year-old age group, those with insulin resistance had lower testicular volume, compared with those without insulin resistance (HOMA index < 2.5). The number of insulin-resistant adolescents was greater than that of controls in the Tanner stage 2 group.

In both the prepubertal (< 9 years) and pubertal (14-16 years) groups, hyperinsulinemia was associated with lower levels of testicular volume.

Hyperinsulinemia did not influence the timing of puberty onset.
 

No way to quantify the effect of obesity on fertility just yet

During a press briefing, Dr. Cannarella commented that obesity is likely just one of several factors influencing what appears to be an increase in male infertility over time. “It isn’t of course the only reason, but many factors in our environment have drastically changed, compared to 40 years ago, including the prevalence of heavy metals and endocrine disruptors, and of course, the change in habits and higher prevalence of metabolic disease. All of this has an impact on the proliferation of Sertoli cells in childhood and this may explain the trend toward the decline of sperm concentration and count.”

Longitudinal data are needed to establish cause and effect, she noted. “We need longitudinal studies that link the degrees of testicular volume with the degree of the sperm concentration and count starting from childhood and ending with the adult age. This is the missing link so far.”

Dr. Cannarella has reported no relevant financial relationships. Dr. Herati has reported being an advisor for Dadi, LiNA Medical, and Teleflex.

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

Dr George Grunberger, of Wayne State University School of Medicine in Detroit, Michigan, discusses key takeaways on the use of insulin in adults with type 2 diabetes from the 2022 American Diabetes Association Scientific Sessions, held June 3-7 in New Orleans, Louisiana. 

Dr Grunberger highlights presentations that address three challenges among insulin users: cost, hypoglycemia, and the high treatment burden of daily injections. 

On cost, Dr Grunberger reports on a study of Basaglar, a follow-on biologic approved to reference Lantus insulin. After 1 year, Basaglar demonstrated comparable A1c lowering and adverse events, higher adherence, and lower cost. 

Next, on hypoglycemia, Dr Grunberger cites the GRADE trial, which examined adding insulin glargine or the sulfonylurea glimepiride to patients taking metformin. The incidence of severe hypoglycemia proved to be lower in the insulin glargine group. 

Finally, Dr Grunberger reported on studies that explored progress in the development of weekly insulin, with an eye toward decreasing treatment burden. 

--

George Grunberger, MD, Chairman, Grunberger Diabetes Institute, Bloomfield Hills; Clinical Professor, Department of Internal Medicine and Molecular Medicine & Genetics, Wayne State University School of Medicine, Detroit, Michigan; Professor, Department of Internal Medicine, Oakland University William Beaumont School of Medicine, Rochester, Michigan 

George Grunberger, MD, has disclosed the following relevant financial relationships:  

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Nevro; Lifescan  

Serve(d) as a speaker or a member of a speakers bureau for: Eli Lilly; Novo Nordisk 

Dr George Grunberger, of Wayne State University School of Medicine in Detroit, Michigan, discusses key takeaways on the use of insulin in adults with type 2 diabetes from the 2022 American Diabetes Association Scientific Sessions, held June 3-7 in New Orleans, Louisiana. 

Dr Grunberger highlights presentations that address three challenges among insulin users: cost, hypoglycemia, and the high treatment burden of daily injections. 

On cost, Dr Grunberger reports on a study of Basaglar, a follow-on biologic approved to reference Lantus insulin. After 1 year, Basaglar demonstrated comparable A1c lowering and adverse events, higher adherence, and lower cost. 

Next, on hypoglycemia, Dr Grunberger cites the GRADE trial, which examined adding insulin glargine or the sulfonylurea glimepiride to patients taking metformin. The incidence of severe hypoglycemia proved to be lower in the insulin glargine group. 

Finally, Dr Grunberger reported on studies that explored progress in the development of weekly insulin, with an eye toward decreasing treatment burden. 

--

George Grunberger, MD, Chairman, Grunberger Diabetes Institute, Bloomfield Hills; Clinical Professor, Department of Internal Medicine and Molecular Medicine & Genetics, Wayne State University School of Medicine, Detroit, Michigan; Professor, Department of Internal Medicine, Oakland University William Beaumont School of Medicine, Rochester, Michigan 

George Grunberger, MD, has disclosed the following relevant financial relationships:  

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Nevro; Lifescan  

Serve(d) as a speaker or a member of a speakers bureau for: Eli Lilly; Novo Nordisk 

Dr George Grunberger, of Wayne State University School of Medicine in Detroit, Michigan, discusses key takeaways on the use of insulin in adults with type 2 diabetes from the 2022 American Diabetes Association Scientific Sessions, held June 3-7 in New Orleans, Louisiana. 

Dr Grunberger highlights presentations that address three challenges among insulin users: cost, hypoglycemia, and the high treatment burden of daily injections. 

On cost, Dr Grunberger reports on a study of Basaglar, a follow-on biologic approved to reference Lantus insulin. After 1 year, Basaglar demonstrated comparable A1c lowering and adverse events, higher adherence, and lower cost. 

Next, on hypoglycemia, Dr Grunberger cites the GRADE trial, which examined adding insulin glargine or the sulfonylurea glimepiride to patients taking metformin. The incidence of severe hypoglycemia proved to be lower in the insulin glargine group. 

Finally, Dr Grunberger reported on studies that explored progress in the development of weekly insulin, with an eye toward decreasing treatment burden. 

--

George Grunberger, MD, Chairman, Grunberger Diabetes Institute, Bloomfield Hills; Clinical Professor, Department of Internal Medicine and Molecular Medicine & Genetics, Wayne State University School of Medicine, Detroit, Michigan; Professor, Department of Internal Medicine, Oakland University William Beaumont School of Medicine, Rochester, Michigan 

George Grunberger, MD, has disclosed the following relevant financial relationships:  

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Nevro; Lifescan  

Serve(d) as a speaker or a member of a speakers bureau for: Eli Lilly; Novo Nordisk 

New guidelines and key studies in glycemic control from the 2022 annual meeting of the American Diabetes Association (ADA) are highlighted by Dr Ildiko Lingvay, from the University of Texas Southwestern Medical Center.  

Dr Lingvay opens by reporting on forthcoming guidelines by the ADA in joint partnership with the European Association for the Study of Diabetes (EASD) on the treatment of hyperglycemia in type 2 diabetes. This consensus paper, she says, will endorse a holistic, person-centered approach to managing type 2 diabetes. The finalized paper will be presented at the EASD annual meeting in Stockholm in September 2022. Next, Dr Lingvay discusses the yearly update to the ADA Standards of Medical Care in Diabetes, which include the benefits of finerenone, the benefits of SGLT2 inhibitors on heart failure and renal outcomes, and the endorsement of the updated eGFR calculator, which omits patient race from calculations.   

She then looks at the SURMOUNT-1 study, a phase 3 trial investigating tirzepatide, a dual GLP/GLP-1 receptor agonist, for the treatment of obesity. In addition to a demonstration of substantial weight loss, the study indicated that tirzepatide provided impressive glucose-lowering benefit. 

Dr Lingvay also examines post hoc data from the STEP 1 and 4 trials showing that semaglutide, compared with placebo, reduced the risk for type 2 diabetes in patients with obesity by approximately 60%, regardless of their baseline glycemic status.  

Finally, Dr Lingvay discusses a novel triple GIP, GLP-1, and glucagon receptor agonist called LY3437943, currently in phase 1 trials, which demonstrated promising glycemic and body weight lowering efficacy after a short 12-week trial.  

--

Ildiko Lingvay, MD, MPH, Professor, Department of Internal Medicine, Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas 

Ildiko Lingvay, MD, MPH, has disclosed the following relevant financial relationships: 

Received income in an amount equal to or greater than $250 from: NovoNordisk; Sanofi; Eli Lilly; AstraZeneca; Target Pharma; Boehringer Ingelheim; Intercept; Merck; Janssen; Intarcia; Merck  

Received research grant from: NovoNordisk; Mylan; Sanofi; Merck; Pfizer; Boehringer Ingelheim 

New guidelines and key studies in glycemic control from the 2022 annual meeting of the American Diabetes Association (ADA) are highlighted by Dr Ildiko Lingvay, from the University of Texas Southwestern Medical Center.  

Dr Lingvay opens by reporting on forthcoming guidelines by the ADA in joint partnership with the European Association for the Study of Diabetes (EASD) on the treatment of hyperglycemia in type 2 diabetes. This consensus paper, she says, will endorse a holistic, person-centered approach to managing type 2 diabetes. The finalized paper will be presented at the EASD annual meeting in Stockholm in September 2022. Next, Dr Lingvay discusses the yearly update to the ADA Standards of Medical Care in Diabetes, which include the benefits of finerenone, the benefits of SGLT2 inhibitors on heart failure and renal outcomes, and the endorsement of the updated eGFR calculator, which omits patient race from calculations.   

She then looks at the SURMOUNT-1 study, a phase 3 trial investigating tirzepatide, a dual GLP/GLP-1 receptor agonist, for the treatment of obesity. In addition to a demonstration of substantial weight loss, the study indicated that tirzepatide provided impressive glucose-lowering benefit. 

Dr Lingvay also examines post hoc data from the STEP 1 and 4 trials showing that semaglutide, compared with placebo, reduced the risk for type 2 diabetes in patients with obesity by approximately 60%, regardless of their baseline glycemic status.  

Finally, Dr Lingvay discusses a novel triple GIP, GLP-1, and glucagon receptor agonist called LY3437943, currently in phase 1 trials, which demonstrated promising glycemic and body weight lowering efficacy after a short 12-week trial.  

--

Ildiko Lingvay, MD, MPH, Professor, Department of Internal Medicine, Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas 

Ildiko Lingvay, MD, MPH, has disclosed the following relevant financial relationships: 

Received income in an amount equal to or greater than $250 from: NovoNordisk; Sanofi; Eli Lilly; AstraZeneca; Target Pharma; Boehringer Ingelheim; Intercept; Merck; Janssen; Intarcia; Merck  

Received research grant from: NovoNordisk; Mylan; Sanofi; Merck; Pfizer; Boehringer Ingelheim 

New guidelines and key studies in glycemic control from the 2022 annual meeting of the American Diabetes Association (ADA) are highlighted by Dr Ildiko Lingvay, from the University of Texas Southwestern Medical Center.  

Dr Lingvay opens by reporting on forthcoming guidelines by the ADA in joint partnership with the European Association for the Study of Diabetes (EASD) on the treatment of hyperglycemia in type 2 diabetes. This consensus paper, she says, will endorse a holistic, person-centered approach to managing type 2 diabetes. The finalized paper will be presented at the EASD annual meeting in Stockholm in September 2022. Next, Dr Lingvay discusses the yearly update to the ADA Standards of Medical Care in Diabetes, which include the benefits of finerenone, the benefits of SGLT2 inhibitors on heart failure and renal outcomes, and the endorsement of the updated eGFR calculator, which omits patient race from calculations.   

She then looks at the SURMOUNT-1 study, a phase 3 trial investigating tirzepatide, a dual GLP/GLP-1 receptor agonist, for the treatment of obesity. In addition to a demonstration of substantial weight loss, the study indicated that tirzepatide provided impressive glucose-lowering benefit. 

Dr Lingvay also examines post hoc data from the STEP 1 and 4 trials showing that semaglutide, compared with placebo, reduced the risk for type 2 diabetes in patients with obesity by approximately 60%, regardless of their baseline glycemic status.  

Finally, Dr Lingvay discusses a novel triple GIP, GLP-1, and glucagon receptor agonist called LY3437943, currently in phase 1 trials, which demonstrated promising glycemic and body weight lowering efficacy after a short 12-week trial.  

--

Ildiko Lingvay, MD, MPH, Professor, Department of Internal Medicine, Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas 

Ildiko Lingvay, MD, MPH, has disclosed the following relevant financial relationships: 

Received income in an amount equal to or greater than $250 from: NovoNordisk; Sanofi; Eli Lilly; AstraZeneca; Target Pharma; Boehringer Ingelheim; Intercept; Merck; Janssen; Intarcia; Merck  

Received research grant from: NovoNordisk; Mylan; Sanofi; Merck; Pfizer; Boehringer Ingelheim 

LONDON – Around the world, nonalcoholic fatty liver disease (NAFLD) has driven an increase in deaths from liver cancer over the past decade, overtaking alcoholic liver disease, hepatitis B, and hepatitis C, according to an analysis of the Global Burden of Disease Study 2019.

A global rise in liver cancer deaths and chronic liver disease reflects changes in underlying health patterns, said Zobair Younossi, MD, MPH, professor and chair, department of medicine, Inova Fairfax Medical Campus, Falls Church, Va., who presented the analysis at the meeting sponsored by the European Association for the Study of the Liver.

“NAFLD and NASH [nonalcoholic steatohepatitis] are rapidly becoming the main causes of cirrhosis and liver cancer in the world,” Dr. Younossi told this news organization. “We have known about the increasing prevalence for some time, but now the outcomes in terms of mortality are catching up,” he said.

“The bottom line of this study is that the burden of this disease [NAFLD] is going up, and it will be the most important disease of the next decade or so,” he said, adding that “the largest annual percentage increase in rates of mortality from liver cancer or chronic liver disease cirrhosis is related to NAFLD.”

Specifically, during the decade of 2009–2019, the annual percent change of +1.33% in the global liver cancer death rate was driven by the fact that the APC for NAFLD was +2.47%. By comparison, the APC for alcoholic liver disease was +1.91%; for hepatitis B, the APC was +0.21%; and for hepatitis C, the APC was +1.12%.

Aleksander Krag, MD, PhD, professor and senior consultant of hepatology and director of Odense (Denmark) Liver Research Centre at SDU and Odense University Hospital, who chaired the session in which this presentation was a part, acknowledged the importance of recognizing the contribution of NAFLD to liver cancer mortality.

“Liver diseases are on the rise. They are the fastest rising cause of death in the United Kingdom, faster than heart disease and other cancers. NAFLD in particular is the fastest growing cause of liver cancer, and the leading cause in France and the United States,” he remarked.

Dr. Krag also highlighted the costs of disease management.

“Managing fatty liver disease in Europe is estimated at €35 billion in direct health care, so we need to do something now,” he stressed.

“The global burden of NAFLD is so high that we need both prevention and treatment tools,” Dr. Krag said. “Change to lifestyle is a ‘no-brainer’ and costs governments very little. For the sake of our young people, we need to take this very seriously. At a political level, we can easily implement this, for example, by banning junk food advertisements, but also educating young people and their families. Good drugs will also help.”
 

NAFLD: The liver manifestation of type 2 diabetes

About 25%-30% of the global population have NAFLD, and 3%-5% have NASH. Dr. Younossi highlighted that the U.S. transplant database shows that NAFLD was the second indication for all liver transplants in the country. NAFLD also was a leading cause of liver transplants for patients with hepatocellular carcinoma.

There are around 2 billion cases of chronic liver disease globally, he said. He noted that, over time, there has been an increase in all kinds of liver diseases, as reflected in the annual percent change.

“The global epidemic of obesity and type 2 diabetes is driving the rise in NAFLD, but even among lean people, the prevalence of NAFLD is around 9%,” Dr. Younossi said. “Alongside the eye and kidney complications of diabetes, this is the liver manifestation of type 2 diabetes.”

To assess global liver disease and death, Dr. Younossi and his colleagues turned to the Global Burden of Disease Study, which gathered data from around 7,000 investigators located across 22 different regions of the world, comprising 156 countries.

They calculated the incidence, prevalence, mortality, and disability-adjusted life-years (DALYs) in relation to liver cancer and chronic liver disease, including the APC. They linked the data to changes in four liver diseases: NAFLD, alcoholic liver disease, hepatitis B infection, and hepatitis C infection.

The cases of NAFLD reported in the study had been diagnosed by ultrasound or other imaging. Importantly, the prevalence of NAFLD was adjusted for alcohol use in the various national populations, explained Dr. Younossi.

In 2019, they reported that the overall global prevalence of liver disease reached 1.69 billion (liver cancer, 0.04%; chronic liver disease, 99.96%), with an incidence of 2.59 million (liver cancer, 20.7%; chronic liver disease, 79.3%), mortality of 1.95 million (liver cancer, 24.8%; chronic liver disease, 75.3%), and DALYs of 58.7 million (liver cancer, 21.3%; chronic liver disease, 78.7%).

Between 2009 and 2019, deaths from liver cancer rose by 27.2%, and deaths from chronic liver disease rose by 10.6%. DALYs from liver cancer rose by 21.9%, and DALYs from chronic liver disease were up by 5.1%.

In contrast to the increase in liver cancer deaths, deaths from chronic liver disease decreased (APC, –0.18%). The decrease was driven by a decrease in hepatitis B (APC, –1.83%). APCs for hepatitis C (+0.37%), alcoholic liver disease (+0.45%), and NAFLD (+1.33%) increased.

“The burden of hepatitis B–related mortality has decreased because we have been so good at vaccinating people,” Dr. Younossi remarked.
 

NAFLD ‘exploding’ in Middle East, North Africa, and East Asia

The increase in NAFLD has been seen in all regions of the world, but a breakdown by region shows that NAFLD is primarily “exploding” with highest prevalence and mortality in the Middle East (mostly Egypt, Iran, and Turkey), North Africa, and East Asia, said Dr. Younossi. In addition, there are large increases in the West and South America.

“We knew that the prevalence was high in the Middle East, but we now know that mortality is also high, so we are connecting these data,” said Dr. Younossi.
 

Awareness lacking

Dr. Younossi pressed the fact that awareness among the general population, primary care providers, and policy makers is very low. “From my perspective, raising awareness of NAFLD is the No. 1 priority, and that is the value of this study.”

He added that more people will become aware as testing becomes more manageable.

“There are some noninvasive tests being developed, so in the future, we won’t have to do liver biopsies to diagnose these patients,” he said. “Currently, there are some excellent treatments being developed.”

“The [World Health Organization] does not mention NAFLD as an important noncommunicable disease, and this too has to change,” Dr. Younossi added.

Dr. Younossi has received research funds and/or has consulted for Abbott, Allergan, Bristol-Myers Squibb, Echosens, Genfit, Gilead Sciences, Intercept, Madrigal, Merck, and Novo Nordisk. Dr. Karg disclosed no relevant financial relationships.

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

LONDON – Around the world, nonalcoholic fatty liver disease (NAFLD) has driven an increase in deaths from liver cancer over the past decade, overtaking alcoholic liver disease, hepatitis B, and hepatitis C, according to an analysis of the Global Burden of Disease Study 2019.

A global rise in liver cancer deaths and chronic liver disease reflects changes in underlying health patterns, said Zobair Younossi, MD, MPH, professor and chair, department of medicine, Inova Fairfax Medical Campus, Falls Church, Va., who presented the analysis at the meeting sponsored by the European Association for the Study of the Liver.

“NAFLD and NASH [nonalcoholic steatohepatitis] are rapidly becoming the main causes of cirrhosis and liver cancer in the world,” Dr. Younossi told this news organization. “We have known about the increasing prevalence for some time, but now the outcomes in terms of mortality are catching up,” he said.

“The bottom line of this study is that the burden of this disease [NAFLD] is going up, and it will be the most important disease of the next decade or so,” he said, adding that “the largest annual percentage increase in rates of mortality from liver cancer or chronic liver disease cirrhosis is related to NAFLD.”

Specifically, during the decade of 2009–2019, the annual percent change of +1.33% in the global liver cancer death rate was driven by the fact that the APC for NAFLD was +2.47%. By comparison, the APC for alcoholic liver disease was +1.91%; for hepatitis B, the APC was +0.21%; and for hepatitis C, the APC was +1.12%.

Aleksander Krag, MD, PhD, professor and senior consultant of hepatology and director of Odense (Denmark) Liver Research Centre at SDU and Odense University Hospital, who chaired the session in which this presentation was a part, acknowledged the importance of recognizing the contribution of NAFLD to liver cancer mortality.

“Liver diseases are on the rise. They are the fastest rising cause of death in the United Kingdom, faster than heart disease and other cancers. NAFLD in particular is the fastest growing cause of liver cancer, and the leading cause in France and the United States,” he remarked.

Dr. Krag also highlighted the costs of disease management.

“Managing fatty liver disease in Europe is estimated at €35 billion in direct health care, so we need to do something now,” he stressed.

“The global burden of NAFLD is so high that we need both prevention and treatment tools,” Dr. Krag said. “Change to lifestyle is a ‘no-brainer’ and costs governments very little. For the sake of our young people, we need to take this very seriously. At a political level, we can easily implement this, for example, by banning junk food advertisements, but also educating young people and their families. Good drugs will also help.”
 

NAFLD: The liver manifestation of type 2 diabetes

About 25%-30% of the global population have NAFLD, and 3%-5% have NASH. Dr. Younossi highlighted that the U.S. transplant database shows that NAFLD was the second indication for all liver transplants in the country. NAFLD also was a leading cause of liver transplants for patients with hepatocellular carcinoma.

There are around 2 billion cases of chronic liver disease globally, he said. He noted that, over time, there has been an increase in all kinds of liver diseases, as reflected in the annual percent change.

“The global epidemic of obesity and type 2 diabetes is driving the rise in NAFLD, but even among lean people, the prevalence of NAFLD is around 9%,” Dr. Younossi said. “Alongside the eye and kidney complications of diabetes, this is the liver manifestation of type 2 diabetes.”

To assess global liver disease and death, Dr. Younossi and his colleagues turned to the Global Burden of Disease Study, which gathered data from around 7,000 investigators located across 22 different regions of the world, comprising 156 countries.

They calculated the incidence, prevalence, mortality, and disability-adjusted life-years (DALYs) in relation to liver cancer and chronic liver disease, including the APC. They linked the data to changes in four liver diseases: NAFLD, alcoholic liver disease, hepatitis B infection, and hepatitis C infection.

The cases of NAFLD reported in the study had been diagnosed by ultrasound or other imaging. Importantly, the prevalence of NAFLD was adjusted for alcohol use in the various national populations, explained Dr. Younossi.

In 2019, they reported that the overall global prevalence of liver disease reached 1.69 billion (liver cancer, 0.04%; chronic liver disease, 99.96%), with an incidence of 2.59 million (liver cancer, 20.7%; chronic liver disease, 79.3%), mortality of 1.95 million (liver cancer, 24.8%; chronic liver disease, 75.3%), and DALYs of 58.7 million (liver cancer, 21.3%; chronic liver disease, 78.7%).

Between 2009 and 2019, deaths from liver cancer rose by 27.2%, and deaths from chronic liver disease rose by 10.6%. DALYs from liver cancer rose by 21.9%, and DALYs from chronic liver disease were up by 5.1%.

In contrast to the increase in liver cancer deaths, deaths from chronic liver disease decreased (APC, –0.18%). The decrease was driven by a decrease in hepatitis B (APC, –1.83%). APCs for hepatitis C (+0.37%), alcoholic liver disease (+0.45%), and NAFLD (+1.33%) increased.

“The burden of hepatitis B–related mortality has decreased because we have been so good at vaccinating people,” Dr. Younossi remarked.
 

NAFLD ‘exploding’ in Middle East, North Africa, and East Asia

The increase in NAFLD has been seen in all regions of the world, but a breakdown by region shows that NAFLD is primarily “exploding” with highest prevalence and mortality in the Middle East (mostly Egypt, Iran, and Turkey), North Africa, and East Asia, said Dr. Younossi. In addition, there are large increases in the West and South America.

“We knew that the prevalence was high in the Middle East, but we now know that mortality is also high, so we are connecting these data,” said Dr. Younossi.
 

Awareness lacking

Dr. Younossi pressed the fact that awareness among the general population, primary care providers, and policy makers is very low. “From my perspective, raising awareness of NAFLD is the No. 1 priority, and that is the value of this study.”

He added that more people will become aware as testing becomes more manageable.

“There are some noninvasive tests being developed, so in the future, we won’t have to do liver biopsies to diagnose these patients,” he said. “Currently, there are some excellent treatments being developed.”

“The [World Health Organization] does not mention NAFLD as an important noncommunicable disease, and this too has to change,” Dr. Younossi added.

Dr. Younossi has received research funds and/or has consulted for Abbott, Allergan, Bristol-Myers Squibb, Echosens, Genfit, Gilead Sciences, Intercept, Madrigal, Merck, and Novo Nordisk. Dr. Karg disclosed no relevant financial relationships.

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

LONDON – Around the world, nonalcoholic fatty liver disease (NAFLD) has driven an increase in deaths from liver cancer over the past decade, overtaking alcoholic liver disease, hepatitis B, and hepatitis C, according to an analysis of the Global Burden of Disease Study 2019.

A global rise in liver cancer deaths and chronic liver disease reflects changes in underlying health patterns, said Zobair Younossi, MD, MPH, professor and chair, department of medicine, Inova Fairfax Medical Campus, Falls Church, Va., who presented the analysis at the meeting sponsored by the European Association for the Study of the Liver.

“NAFLD and NASH [nonalcoholic steatohepatitis] are rapidly becoming the main causes of cirrhosis and liver cancer in the world,” Dr. Younossi told this news organization. “We have known about the increasing prevalence for some time, but now the outcomes in terms of mortality are catching up,” he said.

“The bottom line of this study is that the burden of this disease [NAFLD] is going up, and it will be the most important disease of the next decade or so,” he said, adding that “the largest annual percentage increase in rates of mortality from liver cancer or chronic liver disease cirrhosis is related to NAFLD.”

Specifically, during the decade of 2009–2019, the annual percent change of +1.33% in the global liver cancer death rate was driven by the fact that the APC for NAFLD was +2.47%. By comparison, the APC for alcoholic liver disease was +1.91%; for hepatitis B, the APC was +0.21%; and for hepatitis C, the APC was +1.12%.

Aleksander Krag, MD, PhD, professor and senior consultant of hepatology and director of Odense (Denmark) Liver Research Centre at SDU and Odense University Hospital, who chaired the session in which this presentation was a part, acknowledged the importance of recognizing the contribution of NAFLD to liver cancer mortality.

“Liver diseases are on the rise. They are the fastest rising cause of death in the United Kingdom, faster than heart disease and other cancers. NAFLD in particular is the fastest growing cause of liver cancer, and the leading cause in France and the United States,” he remarked.

Dr. Krag also highlighted the costs of disease management.

“Managing fatty liver disease in Europe is estimated at €35 billion in direct health care, so we need to do something now,” he stressed.

“The global burden of NAFLD is so high that we need both prevention and treatment tools,” Dr. Krag said. “Change to lifestyle is a ‘no-brainer’ and costs governments very little. For the sake of our young people, we need to take this very seriously. At a political level, we can easily implement this, for example, by banning junk food advertisements, but also educating young people and their families. Good drugs will also help.”
 

NAFLD: The liver manifestation of type 2 diabetes

About 25%-30% of the global population have NAFLD, and 3%-5% have NASH. Dr. Younossi highlighted that the U.S. transplant database shows that NAFLD was the second indication for all liver transplants in the country. NAFLD also was a leading cause of liver transplants for patients with hepatocellular carcinoma.

There are around 2 billion cases of chronic liver disease globally, he said. He noted that, over time, there has been an increase in all kinds of liver diseases, as reflected in the annual percent change.

“The global epidemic of obesity and type 2 diabetes is driving the rise in NAFLD, but even among lean people, the prevalence of NAFLD is around 9%,” Dr. Younossi said. “Alongside the eye and kidney complications of diabetes, this is the liver manifestation of type 2 diabetes.”

To assess global liver disease and death, Dr. Younossi and his colleagues turned to the Global Burden of Disease Study, which gathered data from around 7,000 investigators located across 22 different regions of the world, comprising 156 countries.

They calculated the incidence, prevalence, mortality, and disability-adjusted life-years (DALYs) in relation to liver cancer and chronic liver disease, including the APC. They linked the data to changes in four liver diseases: NAFLD, alcoholic liver disease, hepatitis B infection, and hepatitis C infection.

The cases of NAFLD reported in the study had been diagnosed by ultrasound or other imaging. Importantly, the prevalence of NAFLD was adjusted for alcohol use in the various national populations, explained Dr. Younossi.

In 2019, they reported that the overall global prevalence of liver disease reached 1.69 billion (liver cancer, 0.04%; chronic liver disease, 99.96%), with an incidence of 2.59 million (liver cancer, 20.7%; chronic liver disease, 79.3%), mortality of 1.95 million (liver cancer, 24.8%; chronic liver disease, 75.3%), and DALYs of 58.7 million (liver cancer, 21.3%; chronic liver disease, 78.7%).

Between 2009 and 2019, deaths from liver cancer rose by 27.2%, and deaths from chronic liver disease rose by 10.6%. DALYs from liver cancer rose by 21.9%, and DALYs from chronic liver disease were up by 5.1%.

In contrast to the increase in liver cancer deaths, deaths from chronic liver disease decreased (APC, –0.18%). The decrease was driven by a decrease in hepatitis B (APC, –1.83%). APCs for hepatitis C (+0.37%), alcoholic liver disease (+0.45%), and NAFLD (+1.33%) increased.

“The burden of hepatitis B–related mortality has decreased because we have been so good at vaccinating people,” Dr. Younossi remarked.
 

NAFLD ‘exploding’ in Middle East, North Africa, and East Asia

The increase in NAFLD has been seen in all regions of the world, but a breakdown by region shows that NAFLD is primarily “exploding” with highest prevalence and mortality in the Middle East (mostly Egypt, Iran, and Turkey), North Africa, and East Asia, said Dr. Younossi. In addition, there are large increases in the West and South America.

“We knew that the prevalence was high in the Middle East, but we now know that mortality is also high, so we are connecting these data,” said Dr. Younossi.
 

Awareness lacking

Dr. Younossi pressed the fact that awareness among the general population, primary care providers, and policy makers is very low. “From my perspective, raising awareness of NAFLD is the No. 1 priority, and that is the value of this study.”

He added that more people will become aware as testing becomes more manageable.

“There are some noninvasive tests being developed, so in the future, we won’t have to do liver biopsies to diagnose these patients,” he said. “Currently, there are some excellent treatments being developed.”

“The [World Health Organization] does not mention NAFLD as an important noncommunicable disease, and this too has to change,” Dr. Younossi added.

Dr. Younossi has received research funds and/or has consulted for Abbott, Allergan, Bristol-Myers Squibb, Echosens, Genfit, Gilead Sciences, Intercept, Madrigal, Merck, and Novo Nordisk. Dr. Karg disclosed no relevant financial relationships.

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

“[Operative vaginal delivery] was used in only 3% of all US births in 2013, a shift from approximately 30% in 1987,” reported Hayley M. Miller, MD, and Danielle M. Panelli, MD, in the June issue of OBG Management. In their article, “How are maternal and neonatal outcomes impacted by the contemporary practice of operative vaginal delivery [OVD],” the authors mentioned that level of experience by the operator can bias reported complication rates of OVD. Although they examined evidence that found the absolute risk of neonatal trauma to be low following OVD, perineal lacerations “appeared to remain a major driver of maternal morbidity….” Given the current infrequency of OVD, they urged that training be prioritized so OVD can be offered as a safe alternative to cesarean delivery. OBG Management followed up with a poll for readers to ask, “Are you comfortable performing OVD as an alternative to cesarean?”

“[Operative vaginal delivery] was used in only 3% of all US births in 2013, a shift from approximately 30% in 1987,” reported Hayley M. Miller, MD, and Danielle M. Panelli, MD, in the June issue of OBG Management. In their article, “How are maternal and neonatal outcomes impacted by the contemporary practice of operative vaginal delivery [OVD],” the authors mentioned that level of experience by the operator can bias reported complication rates of OVD. Although they examined evidence that found the absolute risk of neonatal trauma to be low following OVD, perineal lacerations “appeared to remain a major driver of maternal morbidity….” Given the current infrequency of OVD, they urged that training be prioritized so OVD can be offered as a safe alternative to cesarean delivery. OBG Management followed up with a poll for readers to ask, “Are you comfortable performing OVD as an alternative to cesarean?”

“[Operative vaginal delivery] was used in only 3% of all US births in 2013, a shift from approximately 30% in 1987,” reported Hayley M. Miller, MD, and Danielle M. Panelli, MD, in the June issue of OBG Management. In their article, “How are maternal and neonatal outcomes impacted by the contemporary practice of operative vaginal delivery [OVD],” the authors mentioned that level of experience by the operator can bias reported complication rates of OVD. Although they examined evidence that found the absolute risk of neonatal trauma to be low following OVD, perineal lacerations “appeared to remain a major driver of maternal morbidity….” Given the current infrequency of OVD, they urged that training be prioritized so OVD can be offered as a safe alternative to cesarean delivery. OBG Management followed up with a poll for readers to ask, “Are you comfortable performing OVD as an alternative to cesarean?”

Dr Anastassios Pittas, Chief of Endocrinology at Tufts Medical Center in Boston, discusses key data from the American Diabetes Association Scientific Sessions 2022 on the management of common comorbidities in diabetes. 

Dr Pittas looks first at a prespecified analysis of the SURPASS-4 trial, which highlighted the role of tirzepatide on kidney outcomes in patients with type 2 diabetes. 

He then discusses results of the SPLENDID trial in which patients with diabetes who received bariatric surgery for weight loss showed reduced rates of cancer.  

Finally, Dr Pittas reports on a study examining the effect of food insecurity and diet quality on maintaining good cholesterol levels in diabetes.

--

Anastassios G. Pittas, MD, Chief, Division of Endocrinology, Diabetes, and Metabolism; Co-director, Diabetes and Lipid Center; Professor of Medicine, Tufts University School of Medicine, Boston, Massachusetts 

Anastassios G. Pittas, MD, has disclosed no relevant financial relationships. 

Dr Anastassios Pittas, Chief of Endocrinology at Tufts Medical Center in Boston, discusses key data from the American Diabetes Association Scientific Sessions 2022 on the management of common comorbidities in diabetes. 

Dr Pittas looks first at a prespecified analysis of the SURPASS-4 trial, which highlighted the role of tirzepatide on kidney outcomes in patients with type 2 diabetes. 

He then discusses results of the SPLENDID trial in which patients with diabetes who received bariatric surgery for weight loss showed reduced rates of cancer.  

Finally, Dr Pittas reports on a study examining the effect of food insecurity and diet quality on maintaining good cholesterol levels in diabetes.

--

Anastassios G. Pittas, MD, Chief, Division of Endocrinology, Diabetes, and Metabolism; Co-director, Diabetes and Lipid Center; Professor of Medicine, Tufts University School of Medicine, Boston, Massachusetts 

Anastassios G. Pittas, MD, has disclosed no relevant financial relationships. 

Dr Anastassios Pittas, Chief of Endocrinology at Tufts Medical Center in Boston, discusses key data from the American Diabetes Association Scientific Sessions 2022 on the management of common comorbidities in diabetes. 

Dr Pittas looks first at a prespecified analysis of the SURPASS-4 trial, which highlighted the role of tirzepatide on kidney outcomes in patients with type 2 diabetes. 

He then discusses results of the SPLENDID trial in which patients with diabetes who received bariatric surgery for weight loss showed reduced rates of cancer.  

Finally, Dr Pittas reports on a study examining the effect of food insecurity and diet quality on maintaining good cholesterol levels in diabetes.

--

Anastassios G. Pittas, MD, Chief, Division of Endocrinology, Diabetes, and Metabolism; Co-director, Diabetes and Lipid Center; Professor of Medicine, Tufts University School of Medicine, Boston, Massachusetts 

Anastassios G. Pittas, MD, has disclosed no relevant financial relationships. 

U.S. maternal deaths – those during pregnancy or within 42 days of pregnancy – increased substantially by 33.3% after March 2020 corresponding to the COVID-19 pandemic onset, according to new research published in JAMA Network Open.

Data from the National Center for Health Statistics (NCHS) revealed this rise in maternal deaths was higher than the 22% overall excess death estimate associated with the pandemic in 2020.

Increases were highest for Hispanic and non-Hispanic Black women, exacerbating already high rates of disparity in comparison with White women, wrote Marie E. Thoma, PhD, an associate professor at the University of Maryland, College Park, and Eugene R. Declercq, PhD, a professor at Boston University.

The authors noted that this spike in maternal deaths might be caused either by conditions directly related to COVID-19, such as respiratory or viral infections, or by conditions worsened by pandemic-associated health care disruptions including those for diabetes or cardiovascular disease.

The precise causes, however, could not be discerned from the data, the authors noted.

The NCHS reported an 18.4% increase in U.S. maternal mortality from 2019 to 2020. The relative increase was 44.4% among Hispanic, 25.7% among non-Hispanic Black, and 6.1% among non-Hispanic White women.

“The rise in maternal mortality among Hispanic women was unprecedented,” Dr. Thoma said in an interview. Given a 16.8% increase in overall U.S. mortality in 2020, largely attributed to the COVID-19 pandemic, the authors examined the pandemic’s role in [the higher] maternal death rates for 2020.

“Prior to this report, the NCHS released an e-report that there had been a rise in maternal mortality in 2020, but questions remained about the role of the pandemic in this rise that their report hadn’t addressed,” Dr. Thoma said in an interview “So we decided to look at the data further to assess whether the rise coincided with the pandemic and how this differed by race/ethnicity, whether there were changes in the causes of maternal death, and how often COVID-19 was listed as a contributory factor in those deaths.”

A total of 1,588 maternal deaths (18.8 per 100,000 live births) occurred before the pandemic versus 684 deaths (25.1 per 100,000 live births) during the 2020 phase of the pandemic, for a relative increase of 33.3%.

Direct obstetrical causes of death included diabetes, hypertensive and liver disorders, pregnancy-related infections, and obstetrical hemorrhage and embolism. Indirect causes comprised, among others, nonobstetrical infections and diseases of the circulatory and respiratory systems as well as mental and nervous disorders.

Relative increases in direct causes (27.7%) were mostly associated with diabetes (95.9%), hypertensive disorders (39.0%), and other specified pregnancy-related conditions (48.0%).

COVID-19 was commonly listed as a lethal condition along with other viral diseases (16 of 16 deaths and diseases of the respiratory system (11 of 19 deaths).

Late maternal mortality – defined as more than 42 days but less than 1 year after pregnancy – increased by 41%. “This was surprising as we might anticipate risk being higher during pregnancy given that pregnant women may be more susceptible, but we see that this rise was also found among people in the later postpartum period,” Dr. Thoma said.

Absolute and relative changes were highest for Hispanic women (8.9 per 100,000 live births and 74.2%, respectively) and non-Hispanic Black women (16.8 per 100,000 live births and 40.2%). In contrast, non-Hispanic White women saw increases of just 2.9 per 100,000 live births and 17.2%.

“Overall, we found the rise in maternal mortality in 2020 was concentrated after the start of pandemic, particularly for non-Hispanic Black and Hispanic women, and we saw a dramatic rise in respiratory-related conditions,” Dr. Thoma said.

In a comment, Steven Woolf, MD, MPH, director emeritus of the Center on Society and Health at Virginia Commonwealth University, Richmond, said the findings are very consistent with his and others research showing dramatic increases in overall death rates from many causes during the pandemic, with these ranging from COVID-19 leading conditions such as diabetes, cardiovascular and Alzheimer’s disease to less-studied causes such as drug overdoses and alcoholism caused by the stresses of the pandemic. Again, deaths were likely caused by both COVID-19 infections and disruptions in diagnosis and care.

“So a rise in maternal mortality would unfortunately also be expected, and these researchers have shown that,” he said in an interview. In addition, they have confirmed “the pattern of stark health disparities in the Hispanic and Black populations relative to the White. Our group has shown marked decreases in the life expectancies of the Black and Hispanic populations relative to the White population.”

While he might take issue with the study’s research methodology, Dr. Woolf said, “The work is useful partly because we need to work out the best research methods to do this kind of analysis because we really need to understand the effects on maternal mortality.”

He said sorting out the best way to do this type of research will be important for looking at excess deaths and maternal mortality following other events, for example, in the wake of the Supreme Court’s recent decision to reverse Roe v. Wade.

The authors acknowledged certain study limitations, including the large percentage of COVID-19 cases with a nonspecific underlying cause. According to Dr. Thoma and Dr. Declercq, that reflects a maternal death coding problem that needs to be addressed, as well as a partitioning of data. The latter resulted in small numbers for some categories, with rates suppressed for fewer than 16 deaths because of reduced reliability.

“We found that more specific information is often available on death certificates but is lost in the process of coding,” said Dr. Thoma. “We were able to reclassify many of these causes to a more specific cause that we attributed to be the primary cause of death.”

The authors said future studies of maternal death should examine the contribution of the pandemic to racial and ethnic disparities and should identify specific causes of maternal deaths overall and associated with COVID-19.

In earlier research, the authors previously warned of possible misclassifications of maternal deaths.

They found evidence of both underreporting and overreporting of deaths, with possible overreporting predominant, whereas accurate data are essential for measuring the effectiveness of maternal mortality reduction programs.

Dr. Thoma’s group will continue to monitor mortality trends with the release of 2021 data. “We hope we will see improvements in 2021 given greater access to vaccines, treatments, and fewer health care disruptions,” Dr. Thoma said. “It will be important to continue to stress the importance of COVID-19 vaccines for pregnant and postpartum people.”

This study had no external funding. The authors disclosed no competing interests. Dr. Woolf declared no conflicts of interest.

U.S. maternal deaths – those during pregnancy or within 42 days of pregnancy – increased substantially by 33.3% after March 2020 corresponding to the COVID-19 pandemic onset, according to new research published in JAMA Network Open.

Data from the National Center for Health Statistics (NCHS) revealed this rise in maternal deaths was higher than the 22% overall excess death estimate associated with the pandemic in 2020.

Increases were highest for Hispanic and non-Hispanic Black women, exacerbating already high rates of disparity in comparison with White women, wrote Marie E. Thoma, PhD, an associate professor at the University of Maryland, College Park, and Eugene R. Declercq, PhD, a professor at Boston University.

The authors noted that this spike in maternal deaths might be caused either by conditions directly related to COVID-19, such as respiratory or viral infections, or by conditions worsened by pandemic-associated health care disruptions including those for diabetes or cardiovascular disease.

The precise causes, however, could not be discerned from the data, the authors noted.

The NCHS reported an 18.4% increase in U.S. maternal mortality from 2019 to 2020. The relative increase was 44.4% among Hispanic, 25.7% among non-Hispanic Black, and 6.1% among non-Hispanic White women.

“The rise in maternal mortality among Hispanic women was unprecedented,” Dr. Thoma said in an interview. Given a 16.8% increase in overall U.S. mortality in 2020, largely attributed to the COVID-19 pandemic, the authors examined the pandemic’s role in [the higher] maternal death rates for 2020.

“Prior to this report, the NCHS released an e-report that there had been a rise in maternal mortality in 2020, but questions remained about the role of the pandemic in this rise that their report hadn’t addressed,” Dr. Thoma said in an interview “So we decided to look at the data further to assess whether the rise coincided with the pandemic and how this differed by race/ethnicity, whether there were changes in the causes of maternal death, and how often COVID-19 was listed as a contributory factor in those deaths.”

A total of 1,588 maternal deaths (18.8 per 100,000 live births) occurred before the pandemic versus 684 deaths (25.1 per 100,000 live births) during the 2020 phase of the pandemic, for a relative increase of 33.3%.

Direct obstetrical causes of death included diabetes, hypertensive and liver disorders, pregnancy-related infections, and obstetrical hemorrhage and embolism. Indirect causes comprised, among others, nonobstetrical infections and diseases of the circulatory and respiratory systems as well as mental and nervous disorders.

Relative increases in direct causes (27.7%) were mostly associated with diabetes (95.9%), hypertensive disorders (39.0%), and other specified pregnancy-related conditions (48.0%).

COVID-19 was commonly listed as a lethal condition along with other viral diseases (16 of 16 deaths and diseases of the respiratory system (11 of 19 deaths).

Late maternal mortality – defined as more than 42 days but less than 1 year after pregnancy – increased by 41%. “This was surprising as we might anticipate risk being higher during pregnancy given that pregnant women may be more susceptible, but we see that this rise was also found among people in the later postpartum period,” Dr. Thoma said.

Absolute and relative changes were highest for Hispanic women (8.9 per 100,000 live births and 74.2%, respectively) and non-Hispanic Black women (16.8 per 100,000 live births and 40.2%). In contrast, non-Hispanic White women saw increases of just 2.9 per 100,000 live births and 17.2%.

“Overall, we found the rise in maternal mortality in 2020 was concentrated after the start of pandemic, particularly for non-Hispanic Black and Hispanic women, and we saw a dramatic rise in respiratory-related conditions,” Dr. Thoma said.

In a comment, Steven Woolf, MD, MPH, director emeritus of the Center on Society and Health at Virginia Commonwealth University, Richmond, said the findings are very consistent with his and others research showing dramatic increases in overall death rates from many causes during the pandemic, with these ranging from COVID-19 leading conditions such as diabetes, cardiovascular and Alzheimer’s disease to less-studied causes such as drug overdoses and alcoholism caused by the stresses of the pandemic. Again, deaths were likely caused by both COVID-19 infections and disruptions in diagnosis and care.

“So a rise in maternal mortality would unfortunately also be expected, and these researchers have shown that,” he said in an interview. In addition, they have confirmed “the pattern of stark health disparities in the Hispanic and Black populations relative to the White. Our group has shown marked decreases in the life expectancies of the Black and Hispanic populations relative to the White population.”

While he might take issue with the study’s research methodology, Dr. Woolf said, “The work is useful partly because we need to work out the best research methods to do this kind of analysis because we really need to understand the effects on maternal mortality.”

He said sorting out the best way to do this type of research will be important for looking at excess deaths and maternal mortality following other events, for example, in the wake of the Supreme Court’s recent decision to reverse Roe v. Wade.

The authors acknowledged certain study limitations, including the large percentage of COVID-19 cases with a nonspecific underlying cause. According to Dr. Thoma and Dr. Declercq, that reflects a maternal death coding problem that needs to be addressed, as well as a partitioning of data. The latter resulted in small numbers for some categories, with rates suppressed for fewer than 16 deaths because of reduced reliability.

“We found that more specific information is often available on death certificates but is lost in the process of coding,” said Dr. Thoma. “We were able to reclassify many of these causes to a more specific cause that we attributed to be the primary cause of death.”

The authors said future studies of maternal death should examine the contribution of the pandemic to racial and ethnic disparities and should identify specific causes of maternal deaths overall and associated with COVID-19.

In earlier research, the authors previously warned of possible misclassifications of maternal deaths.

They found evidence of both underreporting and overreporting of deaths, with possible overreporting predominant, whereas accurate data are essential for measuring the effectiveness of maternal mortality reduction programs.

Dr. Thoma’s group will continue to monitor mortality trends with the release of 2021 data. “We hope we will see improvements in 2021 given greater access to vaccines, treatments, and fewer health care disruptions,” Dr. Thoma said. “It will be important to continue to stress the importance of COVID-19 vaccines for pregnant and postpartum people.”

This study had no external funding. The authors disclosed no competing interests. Dr. Woolf declared no conflicts of interest.

U.S. maternal deaths – those during pregnancy or within 42 days of pregnancy – increased substantially by 33.3% after March 2020 corresponding to the COVID-19 pandemic onset, according to new research published in JAMA Network Open.

Data from the National Center for Health Statistics (NCHS) revealed this rise in maternal deaths was higher than the 22% overall excess death estimate associated with the pandemic in 2020.

Increases were highest for Hispanic and non-Hispanic Black women, exacerbating already high rates of disparity in comparison with White women, wrote Marie E. Thoma, PhD, an associate professor at the University of Maryland, College Park, and Eugene R. Declercq, PhD, a professor at Boston University.

The authors noted that this spike in maternal deaths might be caused either by conditions directly related to COVID-19, such as respiratory or viral infections, or by conditions worsened by pandemic-associated health care disruptions including those for diabetes or cardiovascular disease.

The precise causes, however, could not be discerned from the data, the authors noted.

The NCHS reported an 18.4% increase in U.S. maternal mortality from 2019 to 2020. The relative increase was 44.4% among Hispanic, 25.7% among non-Hispanic Black, and 6.1% among non-Hispanic White women.

“The rise in maternal mortality among Hispanic women was unprecedented,” Dr. Thoma said in an interview. Given a 16.8% increase in overall U.S. mortality in 2020, largely attributed to the COVID-19 pandemic, the authors examined the pandemic’s role in [the higher] maternal death rates for 2020.

“Prior to this report, the NCHS released an e-report that there had been a rise in maternal mortality in 2020, but questions remained about the role of the pandemic in this rise that their report hadn’t addressed,” Dr. Thoma said in an interview “So we decided to look at the data further to assess whether the rise coincided with the pandemic and how this differed by race/ethnicity, whether there were changes in the causes of maternal death, and how often COVID-19 was listed as a contributory factor in those deaths.”

A total of 1,588 maternal deaths (18.8 per 100,000 live births) occurred before the pandemic versus 684 deaths (25.1 per 100,000 live births) during the 2020 phase of the pandemic, for a relative increase of 33.3%.

Direct obstetrical causes of death included diabetes, hypertensive and liver disorders, pregnancy-related infections, and obstetrical hemorrhage and embolism. Indirect causes comprised, among others, nonobstetrical infections and diseases of the circulatory and respiratory systems as well as mental and nervous disorders.

Relative increases in direct causes (27.7%) were mostly associated with diabetes (95.9%), hypertensive disorders (39.0%), and other specified pregnancy-related conditions (48.0%).

COVID-19 was commonly listed as a lethal condition along with other viral diseases (16 of 16 deaths and diseases of the respiratory system (11 of 19 deaths).

Late maternal mortality – defined as more than 42 days but less than 1 year after pregnancy – increased by 41%. “This was surprising as we might anticipate risk being higher during pregnancy given that pregnant women may be more susceptible, but we see that this rise was also found among people in the later postpartum period,” Dr. Thoma said.

Absolute and relative changes were highest for Hispanic women (8.9 per 100,000 live births and 74.2%, respectively) and non-Hispanic Black women (16.8 per 100,000 live births and 40.2%). In contrast, non-Hispanic White women saw increases of just 2.9 per 100,000 live births and 17.2%.

“Overall, we found the rise in maternal mortality in 2020 was concentrated after the start of pandemic, particularly for non-Hispanic Black and Hispanic women, and we saw a dramatic rise in respiratory-related conditions,” Dr. Thoma said.

In a comment, Steven Woolf, MD, MPH, director emeritus of the Center on Society and Health at Virginia Commonwealth University, Richmond, said the findings are very consistent with his and others research showing dramatic increases in overall death rates from many causes during the pandemic, with these ranging from COVID-19 leading conditions such as diabetes, cardiovascular and Alzheimer’s disease to less-studied causes such as drug overdoses and alcoholism caused by the stresses of the pandemic. Again, deaths were likely caused by both COVID-19 infections and disruptions in diagnosis and care.

“So a rise in maternal mortality would unfortunately also be expected, and these researchers have shown that,” he said in an interview. In addition, they have confirmed “the pattern of stark health disparities in the Hispanic and Black populations relative to the White. Our group has shown marked decreases in the life expectancies of the Black and Hispanic populations relative to the White population.”

While he might take issue with the study’s research methodology, Dr. Woolf said, “The work is useful partly because we need to work out the best research methods to do this kind of analysis because we really need to understand the effects on maternal mortality.”

He said sorting out the best way to do this type of research will be important for looking at excess deaths and maternal mortality following other events, for example, in the wake of the Supreme Court’s recent decision to reverse Roe v. Wade.

The authors acknowledged certain study limitations, including the large percentage of COVID-19 cases with a nonspecific underlying cause. According to Dr. Thoma and Dr. Declercq, that reflects a maternal death coding problem that needs to be addressed, as well as a partitioning of data. The latter resulted in small numbers for some categories, with rates suppressed for fewer than 16 deaths because of reduced reliability.

“We found that more specific information is often available on death certificates but is lost in the process of coding,” said Dr. Thoma. “We were able to reclassify many of these causes to a more specific cause that we attributed to be the primary cause of death.”

The authors said future studies of maternal death should examine the contribution of the pandemic to racial and ethnic disparities and should identify specific causes of maternal deaths overall and associated with COVID-19.

In earlier research, the authors previously warned of possible misclassifications of maternal deaths.

They found evidence of both underreporting and overreporting of deaths, with possible overreporting predominant, whereas accurate data are essential for measuring the effectiveness of maternal mortality reduction programs.

Dr. Thoma’s group will continue to monitor mortality trends with the release of 2021 data. “We hope we will see improvements in 2021 given greater access to vaccines, treatments, and fewer health care disruptions,” Dr. Thoma said. “It will be important to continue to stress the importance of COVID-19 vaccines for pregnant and postpartum people.”

This study had no external funding. The authors disclosed no competing interests. Dr. Woolf declared no conflicts of interest.

WASHINGTON (Reuters) – A pill used to terminate early pregnancies is unlikely to become available without a prescription for years, if ever, experts told Reuters, as the conservative-leaning U.S. Supreme Court dramatically curbed abortion rights.

The Supreme Court on June 24 overturned the landmark 1973 Roe v. Wade ruling that recognized the constitutional right to an abortion and legalized it nationwide. The new ruling stung abortion rights advocates and was a momentous victory to Republicans and religious conservatives.

Many U.S. states are expected to severely limit or outright ban abortions following the Supreme Court ruling. President Joe Biden’s administration is considering options to increase access to so-called medication abortions, which can be administered at home.

“Today I am directing the Department of Health & Human Services to take steps to ensure these critical medications are available to the fullest extent possible,” Mr. Biden said in remarks from the White House.

The pill, mifepristone, is used in combination with a second drug called misoprostol to induce an abortion up to 10 weeks into a pregnancy and is heavily restricted – only available through a certified doctor’s prescription. Abortion rights activists have stepped up calls to make it available for anyone to buy at pharmacies without a prescription.

“We will double down and use every lever we have to protect access to abortion care,” Secretary of Health and Human Services Xavier Becerra said in a statement, adding the department was committed to ensuring access to “medication abortion that has been approved by the FDA for over 20 years.”

Neither Mr. Biden nor Mr. Becerra addressed making the pills available over-the-counter, a process that could take years according to medical and regulatory experts interviewed by Reuters. They said drugmakers would need to conduct new studies showing directions on the product’s packaging would enable a consumer to safely use it without professional medical guidance.

The two companies that make the pill for the U.S. market have shown no interest in conducting the research. Should they do so, any Food and Drug Administration approval would become a target for lawsuits from abortion opponents that could delay implementation for years, experts said.

“The hard part that I see is getting the evidence or the agreement that no prescriber is needed at all,” said Susan Wood, a former Assistant Commissioner for Women’s Health at the FDA.

“I personally don’t see it happening in the next couple of years,” said Ms. Wood, now director of George Washington University’s Jacobs Institute of Women’s Health.
 

The next battle

Access to abortion pills is expected to become the next big battle, as their use is harder to track. The FDA has already relaxed some restrictions, making it easier for certified doctors to prescribe them.

The agency now allows doctors to prescribe mifepristone after a telehealth visit rather than in-person. Patients can receive it by mail, making it easier for women in U.S. states that already restrict its use.

The White House has already considered making abortion pills available online and from pharmacies abroad, with a prescription. However, the import possibility has been curtailed by Congress in broader legislation about drug regulation.

An over-the-counter designation would make it much easier for pregnant women to access the pills in states that seek to restrict their use. For example, they could more easily be mailed to a patient from a friend or supporter in a state where they are not banned.

An FDA spokesperson declined to comment on whether over-the-counter use of abortion pills has been considered. A spokesperson for Danco Laboratories, a manufacturer of mifepristone, said that it does not plan to seek over-the-counter approval. GenBioPro, the second maker of mifepristone for the U.S. market, did not respond to requests for comment.
 

Are they safe?

Medication abortion involves two drugs, taken over a day or two. The first, mifepristone, blocks the pregnancy-sustaining hormone progesterone. The second, misoprostol, induces uterine contractions.

When taken together, the pills halt the pregnancy and prompt cramping and bleeding to empty the uterus, in a process similar to miscarriage.

Abortion rights activists say the pills have a long track record of being safe and effective, with no risk of overdose or addiction. In several countries, including India and Mexico, women can buy mifepristone and misoprostol without a prescription to induce abortion.

“Medication abortion really does meet all the FDA criteria for an over-the-counter switch,” said Antonia Biggs, associate professor at the University of California, San Francisco’s obstetrics, gynecology and reproductive sciences department.

A recent study by Ms. Biggs and colleagues found that the majority of participants would understand a medication abortion over-the-counter label. Ms. Biggs said she was not in talks with drugmakers over her research.

The Charlotte Lozier Institute and Susan B. Anthony List, which advocate against abortion, have said that the FDA decision to relax restrictions on mifepristone ignored data on complications and put women at risk.

Others point to the decade-long legal fight for over-the-counter Plan B, a form of emergency contraception taken within days of sexual intercourse to prevent a pregnancy. Approval for women 18 and over was granted in 2006 and for use by women of all ages in 2013.

“There was very strong support that you did not need a prescriber,” said Ms. Wood, who resigned from the FDA in 2005 over the delay. “Everybody under the sun agreed except for a small group of people who somehow had an enormous political influence.”

Reuters Health Information © 2022 

WASHINGTON (Reuters) – A pill used to terminate early pregnancies is unlikely to become available without a prescription for years, if ever, experts told Reuters, as the conservative-leaning U.S. Supreme Court dramatically curbed abortion rights.

The Supreme Court on June 24 overturned the landmark 1973 Roe v. Wade ruling that recognized the constitutional right to an abortion and legalized it nationwide. The new ruling stung abortion rights advocates and was a momentous victory to Republicans and religious conservatives.

Many U.S. states are expected to severely limit or outright ban abortions following the Supreme Court ruling. President Joe Biden’s administration is considering options to increase access to so-called medication abortions, which can be administered at home.

“Today I am directing the Department of Health & Human Services to take steps to ensure these critical medications are available to the fullest extent possible,” Mr. Biden said in remarks from the White House.

The pill, mifepristone, is used in combination with a second drug called misoprostol to induce an abortion up to 10 weeks into a pregnancy and is heavily restricted – only available through a certified doctor’s prescription. Abortion rights activists have stepped up calls to make it available for anyone to buy at pharmacies without a prescription.

“We will double down and use every lever we have to protect access to abortion care,” Secretary of Health and Human Services Xavier Becerra said in a statement, adding the department was committed to ensuring access to “medication abortion that has been approved by the FDA for over 20 years.”

Neither Mr. Biden nor Mr. Becerra addressed making the pills available over-the-counter, a process that could take years according to medical and regulatory experts interviewed by Reuters. They said drugmakers would need to conduct new studies showing directions on the product’s packaging would enable a consumer to safely use it without professional medical guidance.

The two companies that make the pill for the U.S. market have shown no interest in conducting the research. Should they do so, any Food and Drug Administration approval would become a target for lawsuits from abortion opponents that could delay implementation for years, experts said.

“The hard part that I see is getting the evidence or the agreement that no prescriber is needed at all,” said Susan Wood, a former Assistant Commissioner for Women’s Health at the FDA.

“I personally don’t see it happening in the next couple of years,” said Ms. Wood, now director of George Washington University’s Jacobs Institute of Women’s Health.
 

The next battle

Access to abortion pills is expected to become the next big battle, as their use is harder to track. The FDA has already relaxed some restrictions, making it easier for certified doctors to prescribe them.

The agency now allows doctors to prescribe mifepristone after a telehealth visit rather than in-person. Patients can receive it by mail, making it easier for women in U.S. states that already restrict its use.

The White House has already considered making abortion pills available online and from pharmacies abroad, with a prescription. However, the import possibility has been curtailed by Congress in broader legislation about drug regulation.

An over-the-counter designation would make it much easier for pregnant women to access the pills in states that seek to restrict their use. For example, they could more easily be mailed to a patient from a friend or supporter in a state where they are not banned.

An FDA spokesperson declined to comment on whether over-the-counter use of abortion pills has been considered. A spokesperson for Danco Laboratories, a manufacturer of mifepristone, said that it does not plan to seek over-the-counter approval. GenBioPro, the second maker of mifepristone for the U.S. market, did not respond to requests for comment.
 

Are they safe?

Medication abortion involves two drugs, taken over a day or two. The first, mifepristone, blocks the pregnancy-sustaining hormone progesterone. The second, misoprostol, induces uterine contractions.

When taken together, the pills halt the pregnancy and prompt cramping and bleeding to empty the uterus, in a process similar to miscarriage.

Abortion rights activists say the pills have a long track record of being safe and effective, with no risk of overdose or addiction. In several countries, including India and Mexico, women can buy mifepristone and misoprostol without a prescription to induce abortion.

“Medication abortion really does meet all the FDA criteria for an over-the-counter switch,” said Antonia Biggs, associate professor at the University of California, San Francisco’s obstetrics, gynecology and reproductive sciences department.

A recent study by Ms. Biggs and colleagues found that the majority of participants would understand a medication abortion over-the-counter label. Ms. Biggs said she was not in talks with drugmakers over her research.

The Charlotte Lozier Institute and Susan B. Anthony List, which advocate against abortion, have said that the FDA decision to relax restrictions on mifepristone ignored data on complications and put women at risk.

Others point to the decade-long legal fight for over-the-counter Plan B, a form of emergency contraception taken within days of sexual intercourse to prevent a pregnancy. Approval for women 18 and over was granted in 2006 and for use by women of all ages in 2013.

“There was very strong support that you did not need a prescriber,” said Ms. Wood, who resigned from the FDA in 2005 over the delay. “Everybody under the sun agreed except for a small group of people who somehow had an enormous political influence.”

Reuters Health Information © 2022 

WASHINGTON (Reuters) – A pill used to terminate early pregnancies is unlikely to become available without a prescription for years, if ever, experts told Reuters, as the conservative-leaning U.S. Supreme Court dramatically curbed abortion rights.

The Supreme Court on June 24 overturned the landmark 1973 Roe v. Wade ruling that recognized the constitutional right to an abortion and legalized it nationwide. The new ruling stung abortion rights advocates and was a momentous victory to Republicans and religious conservatives.

Many U.S. states are expected to severely limit or outright ban abortions following the Supreme Court ruling. President Joe Biden’s administration is considering options to increase access to so-called medication abortions, which can be administered at home.

“Today I am directing the Department of Health & Human Services to take steps to ensure these critical medications are available to the fullest extent possible,” Mr. Biden said in remarks from the White House.

The pill, mifepristone, is used in combination with a second drug called misoprostol to induce an abortion up to 10 weeks into a pregnancy and is heavily restricted – only available through a certified doctor’s prescription. Abortion rights activists have stepped up calls to make it available for anyone to buy at pharmacies without a prescription.

“We will double down and use every lever we have to protect access to abortion care,” Secretary of Health and Human Services Xavier Becerra said in a statement, adding the department was committed to ensuring access to “medication abortion that has been approved by the FDA for over 20 years.”

Neither Mr. Biden nor Mr. Becerra addressed making the pills available over-the-counter, a process that could take years according to medical and regulatory experts interviewed by Reuters. They said drugmakers would need to conduct new studies showing directions on the product’s packaging would enable a consumer to safely use it without professional medical guidance.

The two companies that make the pill for the U.S. market have shown no interest in conducting the research. Should they do so, any Food and Drug Administration approval would become a target for lawsuits from abortion opponents that could delay implementation for years, experts said.

“The hard part that I see is getting the evidence or the agreement that no prescriber is needed at all,” said Susan Wood, a former Assistant Commissioner for Women’s Health at the FDA.

“I personally don’t see it happening in the next couple of years,” said Ms. Wood, now director of George Washington University’s Jacobs Institute of Women’s Health.
 

The next battle

Access to abortion pills is expected to become the next big battle, as their use is harder to track. The FDA has already relaxed some restrictions, making it easier for certified doctors to prescribe them.

The agency now allows doctors to prescribe mifepristone after a telehealth visit rather than in-person. Patients can receive it by mail, making it easier for women in U.S. states that already restrict its use.

The White House has already considered making abortion pills available online and from pharmacies abroad, with a prescription. However, the import possibility has been curtailed by Congress in broader legislation about drug regulation.

An over-the-counter designation would make it much easier for pregnant women to access the pills in states that seek to restrict their use. For example, they could more easily be mailed to a patient from a friend or supporter in a state where they are not banned.

An FDA spokesperson declined to comment on whether over-the-counter use of abortion pills has been considered. A spokesperson for Danco Laboratories, a manufacturer of mifepristone, said that it does not plan to seek over-the-counter approval. GenBioPro, the second maker of mifepristone for the U.S. market, did not respond to requests for comment.
 

Are they safe?

Medication abortion involves two drugs, taken over a day or two. The first, mifepristone, blocks the pregnancy-sustaining hormone progesterone. The second, misoprostol, induces uterine contractions.

When taken together, the pills halt the pregnancy and prompt cramping and bleeding to empty the uterus, in a process similar to miscarriage.

Abortion rights activists say the pills have a long track record of being safe and effective, with no risk of overdose or addiction. In several countries, including India and Mexico, women can buy mifepristone and misoprostol without a prescription to induce abortion.

“Medication abortion really does meet all the FDA criteria for an over-the-counter switch,” said Antonia Biggs, associate professor at the University of California, San Francisco’s obstetrics, gynecology and reproductive sciences department.

A recent study by Ms. Biggs and colleagues found that the majority of participants would understand a medication abortion over-the-counter label. Ms. Biggs said she was not in talks with drugmakers over her research.

The Charlotte Lozier Institute and Susan B. Anthony List, which advocate against abortion, have said that the FDA decision to relax restrictions on mifepristone ignored data on complications and put women at risk.

Others point to the decade-long legal fight for over-the-counter Plan B, a form of emergency contraception taken within days of sexual intercourse to prevent a pregnancy. Approval for women 18 and over was granted in 2006 and for use by women of all ages in 2013.

“There was very strong support that you did not need a prescriber,” said Ms. Wood, who resigned from the FDA in 2005 over the delay. “Everybody under the sun agreed except for a small group of people who somehow had an enormous political influence.”

Reuters Health Information © 2022