MDedge ObGyn

TOPLINE:

Mifepristone plus misoprostol reduces the need for subsequent uterine aspiration and emergency department visits in the management of early pregnancy loss. Despite its effectiveness, mifepristone remains underutilized, with 8.6% of patients receiving it in 2022.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using national insurance claims data of US patients with commercial insurance.
• More than 31,000 pregnant women (mean age, 32.7 years) with a diagnosis of early pregnancy loss between 2015 and 2022 were included.
• The diagnosis of patients included having a missed abortion (72.3%), spontaneous abortion (26.9%), or both (0.8%).
• Researchers compared the outcomes of individuals who received a combination of mifepristone and misoprostol vs those who received misoprostol alone. The outcome measures included the need for subsequent procedural management (uterine aspiration), return visits to the emergency department or an outpatient clinic, hospitalizations, and complications within 6 weeks of initial diagnosis.

TAKEAWAY:

• The use of mifepristone was more common in outpatient clinics than in emergency departments (3.4% vs 0.9%; P < .001).
• The use of mifepristone plus misoprostol vs misoprostol alone was linked to a lower incidence of subsequent procedural management (10.5% vs 14.0%; P = .002) and fewer emergency department visits (3.5% vs 7.9%; P < .001).
• The multivariable analysis showed that the use of mifepristone was linked to decreased odds of subsequent procedural management (adjusted odds ratio, 0.71; 95% CI, 0.57-0.87).
• Despite its effectiveness, mifepristone was used in only 8.6% of those receiving medication management for early pregnancy loss in 2022.

IN PRACTICE:

“Continued efforts are needed to reduce barriers to mifepristone use for medication management of EPL,” the authors wrote.

“Any practitioner who cares for patients experiencing early pregnancy loss should consider mifepristone pretreatment to misoprostol to be the standard of care for medication management. Provision of the evidence-based standard of care with the use of mifepristone for early pregnancy loss is an opportunity to advocate for an essential strategy in improving sexual and reproductive health in the US,” wrote Sarita Sonalkar, MD, MPH, and Rachel McKean, MD, MPH, of the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, in an invited commentary.
 

SOURCE:

The study was led by Lyndsey S. Benson, MD, MS, of the University of Washington School of Medicine, Seattle, and was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by the accuracy of the diagnosis of early pregnancy loss and procedure codes because claims data are intended for billing purposes and may be incomplete or inaccurate. The use of de-identified data meant that specific gestational durations, exact dosing, or routes of misoprostol administration could not be determined. The findings may not be generalizable to those with public insurance or no insurance.

DISCLOSURES:

The study was supported in part by a grant from a Women’s Reproductive Health Research grant from the National Institutes of Health Eunice Kennedy Shriver National Institute for Child Health and Human Development. One author reported serving as an adviser and investigator, while another reported receiving personal fees and serving as an expert witness, contributing editor, and course instructor outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Mifepristone plus misoprostol reduces the need for subsequent uterine aspiration and emergency department visits in the management of early pregnancy loss. Despite its effectiveness, mifepristone remains underutilized, with 8.6% of patients receiving it in 2022.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using national insurance claims data of US patients with commercial insurance.
• More than 31,000 pregnant women (mean age, 32.7 years) with a diagnosis of early pregnancy loss between 2015 and 2022 were included.
• The diagnosis of patients included having a missed abortion (72.3%), spontaneous abortion (26.9%), or both (0.8%).
• Researchers compared the outcomes of individuals who received a combination of mifepristone and misoprostol vs those who received misoprostol alone. The outcome measures included the need for subsequent procedural management (uterine aspiration), return visits to the emergency department or an outpatient clinic, hospitalizations, and complications within 6 weeks of initial diagnosis.

TAKEAWAY:

• The use of mifepristone was more common in outpatient clinics than in emergency departments (3.4% vs 0.9%; P < .001).
• The use of mifepristone plus misoprostol vs misoprostol alone was linked to a lower incidence of subsequent procedural management (10.5% vs 14.0%; P = .002) and fewer emergency department visits (3.5% vs 7.9%; P < .001).
• The multivariable analysis showed that the use of mifepristone was linked to decreased odds of subsequent procedural management (adjusted odds ratio, 0.71; 95% CI, 0.57-0.87).
• Despite its effectiveness, mifepristone was used in only 8.6% of those receiving medication management for early pregnancy loss in 2022.

IN PRACTICE:

“Continued efforts are needed to reduce barriers to mifepristone use for medication management of EPL,” the authors wrote.

“Any practitioner who cares for patients experiencing early pregnancy loss should consider mifepristone pretreatment to misoprostol to be the standard of care for medication management. Provision of the evidence-based standard of care with the use of mifepristone for early pregnancy loss is an opportunity to advocate for an essential strategy in improving sexual and reproductive health in the US,” wrote Sarita Sonalkar, MD, MPH, and Rachel McKean, MD, MPH, of the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, in an invited commentary.
 

SOURCE:

The study was led by Lyndsey S. Benson, MD, MS, of the University of Washington School of Medicine, Seattle, and was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by the accuracy of the diagnosis of early pregnancy loss and procedure codes because claims data are intended for billing purposes and may be incomplete or inaccurate. The use of de-identified data meant that specific gestational durations, exact dosing, or routes of misoprostol administration could not be determined. The findings may not be generalizable to those with public insurance or no insurance.

DISCLOSURES:

The study was supported in part by a grant from a Women’s Reproductive Health Research grant from the National Institutes of Health Eunice Kennedy Shriver National Institute for Child Health and Human Development. One author reported serving as an adviser and investigator, while another reported receiving personal fees and serving as an expert witness, contributing editor, and course instructor outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Mifepristone plus misoprostol reduces the need for subsequent uterine aspiration and emergency department visits in the management of early pregnancy loss. Despite its effectiveness, mifepristone remains underutilized, with 8.6% of patients receiving it in 2022.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using national insurance claims data of US patients with commercial insurance.
• More than 31,000 pregnant women (mean age, 32.7 years) with a diagnosis of early pregnancy loss between 2015 and 2022 were included.
• The diagnosis of patients included having a missed abortion (72.3%), spontaneous abortion (26.9%), or both (0.8%).
• Researchers compared the outcomes of individuals who received a combination of mifepristone and misoprostol vs those who received misoprostol alone. The outcome measures included the need for subsequent procedural management (uterine aspiration), return visits to the emergency department or an outpatient clinic, hospitalizations, and complications within 6 weeks of initial diagnosis.

TAKEAWAY:

• The use of mifepristone was more common in outpatient clinics than in emergency departments (3.4% vs 0.9%; P < .001).
• The use of mifepristone plus misoprostol vs misoprostol alone was linked to a lower incidence of subsequent procedural management (10.5% vs 14.0%; P = .002) and fewer emergency department visits (3.5% vs 7.9%; P < .001).
• The multivariable analysis showed that the use of mifepristone was linked to decreased odds of subsequent procedural management (adjusted odds ratio, 0.71; 95% CI, 0.57-0.87).
• Despite its effectiveness, mifepristone was used in only 8.6% of those receiving medication management for early pregnancy loss in 2022.

IN PRACTICE:

“Continued efforts are needed to reduce barriers to mifepristone use for medication management of EPL,” the authors wrote.

“Any practitioner who cares for patients experiencing early pregnancy loss should consider mifepristone pretreatment to misoprostol to be the standard of care for medication management. Provision of the evidence-based standard of care with the use of mifepristone for early pregnancy loss is an opportunity to advocate for an essential strategy in improving sexual and reproductive health in the US,” wrote Sarita Sonalkar, MD, MPH, and Rachel McKean, MD, MPH, of the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, in an invited commentary.
 

SOURCE:

The study was led by Lyndsey S. Benson, MD, MS, of the University of Washington School of Medicine, Seattle, and was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by the accuracy of the diagnosis of early pregnancy loss and procedure codes because claims data are intended for billing purposes and may be incomplete or inaccurate. The use of de-identified data meant that specific gestational durations, exact dosing, or routes of misoprostol administration could not be determined. The findings may not be generalizable to those with public insurance or no insurance.

DISCLOSURES:

The study was supported in part by a grant from a Women’s Reproductive Health Research grant from the National Institutes of Health Eunice Kennedy Shriver National Institute for Child Health and Human Development. One author reported serving as an adviser and investigator, while another reported receiving personal fees and serving as an expert witness, contributing editor, and course instructor outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

While Kellie Lease Stecher, MD, was working as an ob.gyn. in Minneapolis, Minnesota, a patient confided in her a sexual assault allegation about one of Stecher’s male colleagues. Stecher shared the allegation with her supervisor, who told Stecher not to file a report and chose not to address the issue with the patient. Stecher weighed how to do the right thing: Should she speak up? What were the ethical and legal implications of speaking up vs staying silent?

After seeking advice from her mentors, Stecher felt it was her moral and legal duty to report the allegation to the Minnesota Medical Board. Once she did, her supervisor chastised her repeatedly for reporting the allegation. Stecher soon found herself in a hostile work environment where she was regularly singled out and silenced by her supervisor and colleagues.

“I got to a point where I felt like I couldn’t say anything at any meetings without somehow being targeted after the meeting. There was an individual who was even allowed to fat-shame me with no consequences,” Stecher said. “[Being bullied at work is] a struggle because you have no voice, you have no opportunities, and there’s someone who is intentionally making your life uncomfortable.”

Stecher’s experience is not unusual. Mistreatment is a common issue among healthcare workers, ranging from rudeness to bullying and harassment and permeating every level and specialty of the medical profession. A 2019 research review estimated that 26.3% of healthcare workers had experienced bullying and found bullying in healthcare to be associated with mental health problems such as burnout and depression, physical health problems such as insomnia and headaches, and physicians taking more sick leave.

The Medscape Physician Workplace Culture Report 2024 found similarly bleak results:

• 38% said workplace culture is declining.
• 70% don’t see a big commitment from employers for positive culture.
• 48% said staff isn’t committed to positive culture.

Toxicity’s ripple effects contribute to several issues in healthcare, including staffing shortages, physician attrition, inadequate leadership, and even suicide rates.

The irony, of course, is that most physicians enter the field to care for people. As individuals go from medical school to residency and on with the rest of their careers, they often experience a rude awakening.
 

It’s Everywhere

Noticing the prevalence of workplace bullying in the medical field, endocrinologist Farah Khan, MD, at UW Medicine in Seattle, Washington, decided to conduct a survey on the issue.

Khan collected 122 responses from colleagues, friends, and acquaintances in the field. When asked if they had ever been bullied in medicine, 68% of respondents said yes. But here’s the fascinating part: She tried to pinpoint one particular area or source of toxicity in the progression of a physician’s career — and couldn’t because it existed at all levels.

More than one third of respondents said their worst bullying experiences occurred in residency, while 30% said mistreatment was worst in medical school, and 24% indicated their worst experience had occurred once they became an attending.

The litany of experiences included being belittled, excluded, yelled at, criticized, shamed, unfairly blamed, threatened, sexually harassed, subjected to bigotry and slurs, and humiliated.

“What surprised me the most was how widespread this problem is and the many different layers of healthcare it permeates through, from operating room staff to medical students to hospital HR to residents and attendings,” Khan said of her findings.
 

Who Cares for the Caregivers?

When hematologist Mikkael Sekeres, MD, was in medical school, he seriously considered a career as a surgeon. Following success in his surgical rotations, he scrubbed in with a cardiothoracic surgeon who was well known for both his status as a surgeon and his fiery temper. Sekeres witnessed the surgeon yelling at whoever was nearby: Medical students, fellows, residents, operating room nurses.

“At the end of that experience, any passing thoughts I had of going into cardiothoracic surgery were gone,” Sekeres said. “Some of the people I met in surgery were truly wonderful. Some were unhappy people.”

He has clear ideas why. Mental health struggles that are all too common among physicians can be caused or exacerbated by mistreatment and can also lead a physician to mistreat others.

“People bully when they themselves are hurting,” Sekeres said. “It begs the question, why are people hurting? What’s driving them to be bullies? I think part of the reason is that they’re working really hard and they’re tired, and nobody’s caring for them. It’s hard to care for others when you feel as if you’re hurting more than they are.”

Gail Gazelle, MD, experienced something like this. In her case, the pressure to please and to be a perfect professional and mother affected how she interacted with those around her. While working as a hospice medical director and an academician and clinician at Harvard Medical School, Boston, Massachusetts, she found herself feeling exhausted and burnt out but simultaneously guilty for not doing enough at work or at home.

Guess what happened? She became irritable, lashing out at her son and not putting her best foot forward with coworkers or patients.

After trying traditional therapy and self-help through books and podcasts, Gazelle found her solution in life coaching. “I realized just how harsh I was being on myself and found ways to reverse that pattern,” she said. “I learned ways of regulating myself emotionally that I definitely didn’t learn in my training.”

Today, Gazelle works as a life coach herself, guiding physicians through common challenges of the profession — particularly bullying, which she sees often. She remembers one client, an oncologist, who was being targeted by a nurse practitioner she was training. The nurse practitioner began talking back to the oncologist, as well as gossiping and bad-mouthing her to the nurses in the practice. The nurses then began excluding the oncologist from their cafeteria table at lunchtime, which felt blatant in such a small practice.

A core component of Gazelle’s coaching strategy was helping the client reclaim her self-esteem by focusing on her strengths. She instructed the client to write down what went well that day each night rather than lying in bed ruminating. Such self-care strategies can not only help bullied physicians but also prevent some of the challenges that might cause a physician to bully or lash out at another in the first place.

Such strategies, along with the recent influx of wellness programs available in healthcare facilities, can help physicians cope with the mental health impacts of bullying and the job in general. But even life coaches like Gazelle acknowledge that they are often band-aids on the system’s deeper wounds. Bullying in healthcare is not an individual issue; at its core, it’s an institutional one.
 

Negative Hierarchies in Healthcare

When Stecher’s contract expired, she was fired by the supervisor who had been bullying her. Stecher has since filed a lawsuit, claiming sexual discrimination, defamation, and wrongful termination.

The medical field has a long history of hierarchy, and while this rigidity has softened over time, negative hierarchical dynamics are often perpetuated by leaders. Phenomena like cronyism and cliques and behaviors like petty gossip, lunchroom exclusion (which in the worst cases can mimic high school dynamics), and targeting can be at play in the healthcare workplace.

The classic examples, Stecher said, can usually be spotted: “If you threaten the status quo or offer different ideas, you are seen as a threat. Cronyism ... strict hierarchies ... people who elevate individuals in their social arena into leadership positions. Physicians don’t get the leadership training that they really need; they are often just dumped into roles with no previous experience because they’re someone’s golfing buddy.”

The question is how to get workplace culture momentum moving in a positive direction. When Gazelle’s clients are hesitant to voice concerns, she emphasizes doing so can and should benefit leadership, as well as patients and the wider healthcare system.

“The win-win is that you have a healthy culture of respect and dignity and civility rather than the opposite,” she said. “The leader will actually have more staff retention, which everybody’s concerned about, given the shortage of healthcare workers.”

And that’s a key incentive that may not be discussed as much: Talent drain from toxicity. The Medscape Workplace Culture Report asked about culture as it applies to physicians looking to join up. Notably, 93% of doctors say culture is important when mulling a job offer, 70% said culture is equal to money, and 18% ranked it as more important than money, and 46% say a positive atmosphere is the top priority.

Ultimately, it comes down to who is willing to step in and stand up. Respondents to Khan’s survey counted anonymous reporting systems, more supportive administration teams, and zero-tolerance policies as potential remedies. Gazelle, Sekeres, and Stecher all emphasize the need for zero-tolerance policies for bullying and mistreatment.

“We can’t afford to have things going on like this that just destroy the fabric of the healthcare endeavor,” Gazelle said. “They come out sideways eventually. They come out in terms of poor patient care because there are greater errors. There’s a lack of respect for patients. There’s anger and irritability and so much spillover. We have to have zero-tolerance policies from the top down.”

A version of this article appeared on Medscape.com.

While Kellie Lease Stecher, MD, was working as an ob.gyn. in Minneapolis, Minnesota, a patient confided in her a sexual assault allegation about one of Stecher’s male colleagues. Stecher shared the allegation with her supervisor, who told Stecher not to file a report and chose not to address the issue with the patient. Stecher weighed how to do the right thing: Should she speak up? What were the ethical and legal implications of speaking up vs staying silent?

After seeking advice from her mentors, Stecher felt it was her moral and legal duty to report the allegation to the Minnesota Medical Board. Once she did, her supervisor chastised her repeatedly for reporting the allegation. Stecher soon found herself in a hostile work environment where she was regularly singled out and silenced by her supervisor and colleagues.

“I got to a point where I felt like I couldn’t say anything at any meetings without somehow being targeted after the meeting. There was an individual who was even allowed to fat-shame me with no consequences,” Stecher said. “[Being bullied at work is] a struggle because you have no voice, you have no opportunities, and there’s someone who is intentionally making your life uncomfortable.”

Stecher’s experience is not unusual. Mistreatment is a common issue among healthcare workers, ranging from rudeness to bullying and harassment and permeating every level and specialty of the medical profession. A 2019 research review estimated that 26.3% of healthcare workers had experienced bullying and found bullying in healthcare to be associated with mental health problems such as burnout and depression, physical health problems such as insomnia and headaches, and physicians taking more sick leave.

The Medscape Physician Workplace Culture Report 2024 found similarly bleak results:

• 38% said workplace culture is declining.
• 70% don’t see a big commitment from employers for positive culture.
• 48% said staff isn’t committed to positive culture.

Toxicity’s ripple effects contribute to several issues in healthcare, including staffing shortages, physician attrition, inadequate leadership, and even suicide rates.

The irony, of course, is that most physicians enter the field to care for people. As individuals go from medical school to residency and on with the rest of their careers, they often experience a rude awakening.
 

It’s Everywhere

Noticing the prevalence of workplace bullying in the medical field, endocrinologist Farah Khan, MD, at UW Medicine in Seattle, Washington, decided to conduct a survey on the issue.

Khan collected 122 responses from colleagues, friends, and acquaintances in the field. When asked if they had ever been bullied in medicine, 68% of respondents said yes. But here’s the fascinating part: She tried to pinpoint one particular area or source of toxicity in the progression of a physician’s career — and couldn’t because it existed at all levels.

More than one third of respondents said their worst bullying experiences occurred in residency, while 30% said mistreatment was worst in medical school, and 24% indicated their worst experience had occurred once they became an attending.

The litany of experiences included being belittled, excluded, yelled at, criticized, shamed, unfairly blamed, threatened, sexually harassed, subjected to bigotry and slurs, and humiliated.

“What surprised me the most was how widespread this problem is and the many different layers of healthcare it permeates through, from operating room staff to medical students to hospital HR to residents and attendings,” Khan said of her findings.
 

Who Cares for the Caregivers?

When hematologist Mikkael Sekeres, MD, was in medical school, he seriously considered a career as a surgeon. Following success in his surgical rotations, he scrubbed in with a cardiothoracic surgeon who was well known for both his status as a surgeon and his fiery temper. Sekeres witnessed the surgeon yelling at whoever was nearby: Medical students, fellows, residents, operating room nurses.

“At the end of that experience, any passing thoughts I had of going into cardiothoracic surgery were gone,” Sekeres said. “Some of the people I met in surgery were truly wonderful. Some were unhappy people.”

He has clear ideas why. Mental health struggles that are all too common among physicians can be caused or exacerbated by mistreatment and can also lead a physician to mistreat others.

“People bully when they themselves are hurting,” Sekeres said. “It begs the question, why are people hurting? What’s driving them to be bullies? I think part of the reason is that they’re working really hard and they’re tired, and nobody’s caring for them. It’s hard to care for others when you feel as if you’re hurting more than they are.”

Gail Gazelle, MD, experienced something like this. In her case, the pressure to please and to be a perfect professional and mother affected how she interacted with those around her. While working as a hospice medical director and an academician and clinician at Harvard Medical School, Boston, Massachusetts, she found herself feeling exhausted and burnt out but simultaneously guilty for not doing enough at work or at home.

Guess what happened? She became irritable, lashing out at her son and not putting her best foot forward with coworkers or patients.

After trying traditional therapy and self-help through books and podcasts, Gazelle found her solution in life coaching. “I realized just how harsh I was being on myself and found ways to reverse that pattern,” she said. “I learned ways of regulating myself emotionally that I definitely didn’t learn in my training.”

Today, Gazelle works as a life coach herself, guiding physicians through common challenges of the profession — particularly bullying, which she sees often. She remembers one client, an oncologist, who was being targeted by a nurse practitioner she was training. The nurse practitioner began talking back to the oncologist, as well as gossiping and bad-mouthing her to the nurses in the practice. The nurses then began excluding the oncologist from their cafeteria table at lunchtime, which felt blatant in such a small practice.

A core component of Gazelle’s coaching strategy was helping the client reclaim her self-esteem by focusing on her strengths. She instructed the client to write down what went well that day each night rather than lying in bed ruminating. Such self-care strategies can not only help bullied physicians but also prevent some of the challenges that might cause a physician to bully or lash out at another in the first place.

Such strategies, along with the recent influx of wellness programs available in healthcare facilities, can help physicians cope with the mental health impacts of bullying and the job in general. But even life coaches like Gazelle acknowledge that they are often band-aids on the system’s deeper wounds. Bullying in healthcare is not an individual issue; at its core, it’s an institutional one.
 

Negative Hierarchies in Healthcare

When Stecher’s contract expired, she was fired by the supervisor who had been bullying her. Stecher has since filed a lawsuit, claiming sexual discrimination, defamation, and wrongful termination.

The medical field has a long history of hierarchy, and while this rigidity has softened over time, negative hierarchical dynamics are often perpetuated by leaders. Phenomena like cronyism and cliques and behaviors like petty gossip, lunchroom exclusion (which in the worst cases can mimic high school dynamics), and targeting can be at play in the healthcare workplace.

The classic examples, Stecher said, can usually be spotted: “If you threaten the status quo or offer different ideas, you are seen as a threat. Cronyism ... strict hierarchies ... people who elevate individuals in their social arena into leadership positions. Physicians don’t get the leadership training that they really need; they are often just dumped into roles with no previous experience because they’re someone’s golfing buddy.”

The question is how to get workplace culture momentum moving in a positive direction. When Gazelle’s clients are hesitant to voice concerns, she emphasizes doing so can and should benefit leadership, as well as patients and the wider healthcare system.

“The win-win is that you have a healthy culture of respect and dignity and civility rather than the opposite,” she said. “The leader will actually have more staff retention, which everybody’s concerned about, given the shortage of healthcare workers.”

And that’s a key incentive that may not be discussed as much: Talent drain from toxicity. The Medscape Workplace Culture Report asked about culture as it applies to physicians looking to join up. Notably, 93% of doctors say culture is important when mulling a job offer, 70% said culture is equal to money, and 18% ranked it as more important than money, and 46% say a positive atmosphere is the top priority.

Ultimately, it comes down to who is willing to step in and stand up. Respondents to Khan’s survey counted anonymous reporting systems, more supportive administration teams, and zero-tolerance policies as potential remedies. Gazelle, Sekeres, and Stecher all emphasize the need for zero-tolerance policies for bullying and mistreatment.

“We can’t afford to have things going on like this that just destroy the fabric of the healthcare endeavor,” Gazelle said. “They come out sideways eventually. They come out in terms of poor patient care because there are greater errors. There’s a lack of respect for patients. There’s anger and irritability and so much spillover. We have to have zero-tolerance policies from the top down.”

A version of this article appeared on Medscape.com.

While Kellie Lease Stecher, MD, was working as an ob.gyn. in Minneapolis, Minnesota, a patient confided in her a sexual assault allegation about one of Stecher’s male colleagues. Stecher shared the allegation with her supervisor, who told Stecher not to file a report and chose not to address the issue with the patient. Stecher weighed how to do the right thing: Should she speak up? What were the ethical and legal implications of speaking up vs staying silent?

After seeking advice from her mentors, Stecher felt it was her moral and legal duty to report the allegation to the Minnesota Medical Board. Once she did, her supervisor chastised her repeatedly for reporting the allegation. Stecher soon found herself in a hostile work environment where she was regularly singled out and silenced by her supervisor and colleagues.

“I got to a point where I felt like I couldn’t say anything at any meetings without somehow being targeted after the meeting. There was an individual who was even allowed to fat-shame me with no consequences,” Stecher said. “[Being bullied at work is] a struggle because you have no voice, you have no opportunities, and there’s someone who is intentionally making your life uncomfortable.”

Stecher’s experience is not unusual. Mistreatment is a common issue among healthcare workers, ranging from rudeness to bullying and harassment and permeating every level and specialty of the medical profession. A 2019 research review estimated that 26.3% of healthcare workers had experienced bullying and found bullying in healthcare to be associated with mental health problems such as burnout and depression, physical health problems such as insomnia and headaches, and physicians taking more sick leave.

The Medscape Physician Workplace Culture Report 2024 found similarly bleak results:

• 38% said workplace culture is declining.
• 70% don’t see a big commitment from employers for positive culture.
• 48% said staff isn’t committed to positive culture.

Toxicity’s ripple effects contribute to several issues in healthcare, including staffing shortages, physician attrition, inadequate leadership, and even suicide rates.

The irony, of course, is that most physicians enter the field to care for people. As individuals go from medical school to residency and on with the rest of their careers, they often experience a rude awakening.
 

It’s Everywhere

Noticing the prevalence of workplace bullying in the medical field, endocrinologist Farah Khan, MD, at UW Medicine in Seattle, Washington, decided to conduct a survey on the issue.

Khan collected 122 responses from colleagues, friends, and acquaintances in the field. When asked if they had ever been bullied in medicine, 68% of respondents said yes. But here’s the fascinating part: She tried to pinpoint one particular area or source of toxicity in the progression of a physician’s career — and couldn’t because it existed at all levels.

More than one third of respondents said their worst bullying experiences occurred in residency, while 30% said mistreatment was worst in medical school, and 24% indicated their worst experience had occurred once they became an attending.

The litany of experiences included being belittled, excluded, yelled at, criticized, shamed, unfairly blamed, threatened, sexually harassed, subjected to bigotry and slurs, and humiliated.

“What surprised me the most was how widespread this problem is and the many different layers of healthcare it permeates through, from operating room staff to medical students to hospital HR to residents and attendings,” Khan said of her findings.
 

Who Cares for the Caregivers?

When hematologist Mikkael Sekeres, MD, was in medical school, he seriously considered a career as a surgeon. Following success in his surgical rotations, he scrubbed in with a cardiothoracic surgeon who was well known for both his status as a surgeon and his fiery temper. Sekeres witnessed the surgeon yelling at whoever was nearby: Medical students, fellows, residents, operating room nurses.

“At the end of that experience, any passing thoughts I had of going into cardiothoracic surgery were gone,” Sekeres said. “Some of the people I met in surgery were truly wonderful. Some were unhappy people.”

He has clear ideas why. Mental health struggles that are all too common among physicians can be caused or exacerbated by mistreatment and can also lead a physician to mistreat others.

“People bully when they themselves are hurting,” Sekeres said. “It begs the question, why are people hurting? What’s driving them to be bullies? I think part of the reason is that they’re working really hard and they’re tired, and nobody’s caring for them. It’s hard to care for others when you feel as if you’re hurting more than they are.”

Gail Gazelle, MD, experienced something like this. In her case, the pressure to please and to be a perfect professional and mother affected how she interacted with those around her. While working as a hospice medical director and an academician and clinician at Harvard Medical School, Boston, Massachusetts, she found herself feeling exhausted and burnt out but simultaneously guilty for not doing enough at work or at home.

Guess what happened? She became irritable, lashing out at her son and not putting her best foot forward with coworkers or patients.

After trying traditional therapy and self-help through books and podcasts, Gazelle found her solution in life coaching. “I realized just how harsh I was being on myself and found ways to reverse that pattern,” she said. “I learned ways of regulating myself emotionally that I definitely didn’t learn in my training.”

Today, Gazelle works as a life coach herself, guiding physicians through common challenges of the profession — particularly bullying, which she sees often. She remembers one client, an oncologist, who was being targeted by a nurse practitioner she was training. The nurse practitioner began talking back to the oncologist, as well as gossiping and bad-mouthing her to the nurses in the practice. The nurses then began excluding the oncologist from their cafeteria table at lunchtime, which felt blatant in such a small practice.

A core component of Gazelle’s coaching strategy was helping the client reclaim her self-esteem by focusing on her strengths. She instructed the client to write down what went well that day each night rather than lying in bed ruminating. Such self-care strategies can not only help bullied physicians but also prevent some of the challenges that might cause a physician to bully or lash out at another in the first place.

Such strategies, along with the recent influx of wellness programs available in healthcare facilities, can help physicians cope with the mental health impacts of bullying and the job in general. But even life coaches like Gazelle acknowledge that they are often band-aids on the system’s deeper wounds. Bullying in healthcare is not an individual issue; at its core, it’s an institutional one.
 

Negative Hierarchies in Healthcare

When Stecher’s contract expired, she was fired by the supervisor who had been bullying her. Stecher has since filed a lawsuit, claiming sexual discrimination, defamation, and wrongful termination.

The medical field has a long history of hierarchy, and while this rigidity has softened over time, negative hierarchical dynamics are often perpetuated by leaders. Phenomena like cronyism and cliques and behaviors like petty gossip, lunchroom exclusion (which in the worst cases can mimic high school dynamics), and targeting can be at play in the healthcare workplace.

The classic examples, Stecher said, can usually be spotted: “If you threaten the status quo or offer different ideas, you are seen as a threat. Cronyism ... strict hierarchies ... people who elevate individuals in their social arena into leadership positions. Physicians don’t get the leadership training that they really need; they are often just dumped into roles with no previous experience because they’re someone’s golfing buddy.”

The question is how to get workplace culture momentum moving in a positive direction. When Gazelle’s clients are hesitant to voice concerns, she emphasizes doing so can and should benefit leadership, as well as patients and the wider healthcare system.

“The win-win is that you have a healthy culture of respect and dignity and civility rather than the opposite,” she said. “The leader will actually have more staff retention, which everybody’s concerned about, given the shortage of healthcare workers.”

And that’s a key incentive that may not be discussed as much: Talent drain from toxicity. The Medscape Workplace Culture Report asked about culture as it applies to physicians looking to join up. Notably, 93% of doctors say culture is important when mulling a job offer, 70% said culture is equal to money, and 18% ranked it as more important than money, and 46% say a positive atmosphere is the top priority.

Ultimately, it comes down to who is willing to step in and stand up. Respondents to Khan’s survey counted anonymous reporting systems, more supportive administration teams, and zero-tolerance policies as potential remedies. Gazelle, Sekeres, and Stecher all emphasize the need for zero-tolerance policies for bullying and mistreatment.

“We can’t afford to have things going on like this that just destroy the fabric of the healthcare endeavor,” Gazelle said. “They come out sideways eventually. They come out in terms of poor patient care because there are greater errors. There’s a lack of respect for patients. There’s anger and irritability and so much spillover. We have to have zero-tolerance policies from the top down.”

A version of this article appeared on Medscape.com.

A group of nurse practitioners (NPs) employed by the state of New York has sued the state, alleging that their employer has them doing the work of physicians but underpays them.

The New York State Civil Service Commission understates the job function of NPs, overstates their dependence on physicians, and inadequately pays them for their work, according to the complaint filed in the US District Court for the Northern District of New York.

The nurses claim the mistreatment is a consequence of the fact that “at least 80% of the state’s employed NPs are women.”

Michael H. Sussman, a Goshen, New York–based attorney for the nurses, said in an interview that New York NPs are increasingly being used essentially as doctors at state-run facilities, including prisons, yet the state has failed to adequately pay them.

The lawsuit comes after a decade-long attempt by NPs to attain equitable pay and the ability to advance their civil service careers, he said.

“New York state has not addressed the heart of the issue, which is that the classification of this position is much lower than other positions in the state which are not so female-dominated and which engage in very similar activities,” Sussman said.

The lawsuit claims that “the work of NPs is complex, equaling that of a medical specialist, psychiatrist, or clinical physician.”

A spokesman for the New York State Civil Service Commission declined comment, saying the department does not comment on pending litigation.
 

Novel Gender Discrimination Argument

Gender discrimination is a relatively new argument avenue in the larger equal work, equal pay debate, said Joanne Spetz, PhD, director of the Institute for Health Policy Studies at the University of California, San Francisco.

“This is the first time I’ve heard of [such] a case being really gender discrimination focused,” she said in an interview. “On one level, I think it’s groundbreaking as a legal approach, but it’s also limited because it’s focused on public, state employees.”

Spetz noted that New York has significantly expanded NPs’ scope of practice, enacting in 2022 legislation that granted NPs full practice authority. The law means NPs can evaluate, order, diagnose, manage treatments, and prescribe medications for patients without physician supervision.

“They are in a role where they are stepping back and saying, ‘Wait, why are [we] not receiving equal pay for equal work?’ ” Spetz said. “It’s a totally fair area for debate, especially because they are now authorized to do essentially equal work with a high degree of autonomy.”
 

Debate Over Pay Grade

The nurses’ complaint centers on the New York State Civil Service Commission’s classification for NPs, which hasn’t changed since 2006. NPs are classified at grade 24, and they have no possibility of internal advancement associated with their title, according to the legal complaint filed on September 17.

To comply with a state legislative directive, the commission in 2018 conducted a study of the NP classification but recommended against reclassification or implementing a career ladder. The study noted the subordinate role of NPs to physicians and the substantial difference between physician classification (entry at grade 34) and that of NPs, psychologists (grade 25), and pharmacists (grade 25).

The study concluded that higher classified positions have higher levels of educational attainment and licensure requirements and no supervision or collaboration requirements, according to the complaint.

At the time, groups such as the Nurse Practitioner Association and the Public Employees Federation (PEF) criticized the findings, but the commission stuck to its classification.

Following the NP Modernization Act that allowed NPs to practice independently, PEF sought an increase for NPs to grade 28 with a progression to grade 34 depending on experience.

“But to this date, despite altering the starting salaries of NPs, defendants have failed and refused to alter the compensation offered to the substantial majority of NPs, and each plaintiff remains cabined in a grade 24 with a discriminatorily low salary when compared with males in other job classifications doing highly similar functions,” the lawsuit contended.

Six plaintiffs are named in the lawsuit, all of whom are women and work for state agencies. Plaintiff Rachel Burns, for instance, works as a psychiatric mental health NP in West Seneca and is responsible for performing psychiatric evaluations for patients, diagnosis, prescribing medication, ordering labs, and determining risks. The evaluations are identical for a psychiatrist and require her to complete the same forms, according to the suit.

Another plaintiff, Amber Hawthorne Lashway, works at a correctional facility in Altona, where for many years she was the sole medical provider, according to the lawsuit. Lashway’s duties, which include diagnoses and treatment of inmates’ medical conditions, mirror those performed by clinical physicians, the suit stated.

The plaintiffs are requesting the court accept jurisdiction of the matter and certify the class they seek to represent. They are also demanding prospective pay equity and compensatory damages for the distress caused by “the long-standing discriminatory” treatment by the state.

The Civil Service Commission and state of New York have not yet responded to the complaint. Their responses are due on November 12.
 

Attorney: Case Impact Limited

Benjamin McMichael, PhD, JD, said the New York case is not surprising as more states across the country are granting nurses more practice autonomy. The current landscape tends to favor the nurses, he said, with about half of states now allowing NPs full practice authority.

“I think the [New York] NPs are correct that they are underpaid,” said McMichael, an associate professor of law and director of the Interdisciplinary Legal Studies Initiative at The University of Alabama in Tuscaloosa. “With that said, the nature of the case does not clearly lend itself to national change.”

The fact that the NP plaintiffs are employed by the state means they are using a specific set of laws to advance their cause, he said. Other NPs in other employment situations may not have access to the same laws.
 

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

A group of nurse practitioners (NPs) employed by the state of New York has sued the state, alleging that their employer has them doing the work of physicians but underpays them.

The New York State Civil Service Commission understates the job function of NPs, overstates their dependence on physicians, and inadequately pays them for their work, according to the complaint filed in the US District Court for the Northern District of New York.

The nurses claim the mistreatment is a consequence of the fact that “at least 80% of the state’s employed NPs are women.”

Michael H. Sussman, a Goshen, New York–based attorney for the nurses, said in an interview that New York NPs are increasingly being used essentially as doctors at state-run facilities, including prisons, yet the state has failed to adequately pay them.

The lawsuit comes after a decade-long attempt by NPs to attain equitable pay and the ability to advance their civil service careers, he said.

“New York state has not addressed the heart of the issue, which is that the classification of this position is much lower than other positions in the state which are not so female-dominated and which engage in very similar activities,” Sussman said.

The lawsuit claims that “the work of NPs is complex, equaling that of a medical specialist, psychiatrist, or clinical physician.”

A spokesman for the New York State Civil Service Commission declined comment, saying the department does not comment on pending litigation.
 

Novel Gender Discrimination Argument

Gender discrimination is a relatively new argument avenue in the larger equal work, equal pay debate, said Joanne Spetz, PhD, director of the Institute for Health Policy Studies at the University of California, San Francisco.

“This is the first time I’ve heard of [such] a case being really gender discrimination focused,” she said in an interview. “On one level, I think it’s groundbreaking as a legal approach, but it’s also limited because it’s focused on public, state employees.”

Spetz noted that New York has significantly expanded NPs’ scope of practice, enacting in 2022 legislation that granted NPs full practice authority. The law means NPs can evaluate, order, diagnose, manage treatments, and prescribe medications for patients without physician supervision.

“They are in a role where they are stepping back and saying, ‘Wait, why are [we] not receiving equal pay for equal work?’ ” Spetz said. “It’s a totally fair area for debate, especially because they are now authorized to do essentially equal work with a high degree of autonomy.”
 

Debate Over Pay Grade

The nurses’ complaint centers on the New York State Civil Service Commission’s classification for NPs, which hasn’t changed since 2006. NPs are classified at grade 24, and they have no possibility of internal advancement associated with their title, according to the legal complaint filed on September 17.

To comply with a state legislative directive, the commission in 2018 conducted a study of the NP classification but recommended against reclassification or implementing a career ladder. The study noted the subordinate role of NPs to physicians and the substantial difference between physician classification (entry at grade 34) and that of NPs, psychologists (grade 25), and pharmacists (grade 25).

The study concluded that higher classified positions have higher levels of educational attainment and licensure requirements and no supervision or collaboration requirements, according to the complaint.

At the time, groups such as the Nurse Practitioner Association and the Public Employees Federation (PEF) criticized the findings, but the commission stuck to its classification.

Following the NP Modernization Act that allowed NPs to practice independently, PEF sought an increase for NPs to grade 28 with a progression to grade 34 depending on experience.

“But to this date, despite altering the starting salaries of NPs, defendants have failed and refused to alter the compensation offered to the substantial majority of NPs, and each plaintiff remains cabined in a grade 24 with a discriminatorily low salary when compared with males in other job classifications doing highly similar functions,” the lawsuit contended.

Six plaintiffs are named in the lawsuit, all of whom are women and work for state agencies. Plaintiff Rachel Burns, for instance, works as a psychiatric mental health NP in West Seneca and is responsible for performing psychiatric evaluations for patients, diagnosis, prescribing medication, ordering labs, and determining risks. The evaluations are identical for a psychiatrist and require her to complete the same forms, according to the suit.

Another plaintiff, Amber Hawthorne Lashway, works at a correctional facility in Altona, where for many years she was the sole medical provider, according to the lawsuit. Lashway’s duties, which include diagnoses and treatment of inmates’ medical conditions, mirror those performed by clinical physicians, the suit stated.

The plaintiffs are requesting the court accept jurisdiction of the matter and certify the class they seek to represent. They are also demanding prospective pay equity and compensatory damages for the distress caused by “the long-standing discriminatory” treatment by the state.

The Civil Service Commission and state of New York have not yet responded to the complaint. Their responses are due on November 12.
 

Attorney: Case Impact Limited

Benjamin McMichael, PhD, JD, said the New York case is not surprising as more states across the country are granting nurses more practice autonomy. The current landscape tends to favor the nurses, he said, with about half of states now allowing NPs full practice authority.

“I think the [New York] NPs are correct that they are underpaid,” said McMichael, an associate professor of law and director of the Interdisciplinary Legal Studies Initiative at The University of Alabama in Tuscaloosa. “With that said, the nature of the case does not clearly lend itself to national change.”

The fact that the NP plaintiffs are employed by the state means they are using a specific set of laws to advance their cause, he said. Other NPs in other employment situations may not have access to the same laws.
 

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

A group of nurse practitioners (NPs) employed by the state of New York has sued the state, alleging that their employer has them doing the work of physicians but underpays them.

The New York State Civil Service Commission understates the job function of NPs, overstates their dependence on physicians, and inadequately pays them for their work, according to the complaint filed in the US District Court for the Northern District of New York.

The nurses claim the mistreatment is a consequence of the fact that “at least 80% of the state’s employed NPs are women.”

Michael H. Sussman, a Goshen, New York–based attorney for the nurses, said in an interview that New York NPs are increasingly being used essentially as doctors at state-run facilities, including prisons, yet the state has failed to adequately pay them.

The lawsuit comes after a decade-long attempt by NPs to attain equitable pay and the ability to advance their civil service careers, he said.

“New York state has not addressed the heart of the issue, which is that the classification of this position is much lower than other positions in the state which are not so female-dominated and which engage in very similar activities,” Sussman said.

The lawsuit claims that “the work of NPs is complex, equaling that of a medical specialist, psychiatrist, or clinical physician.”

A spokesman for the New York State Civil Service Commission declined comment, saying the department does not comment on pending litigation.
 

Novel Gender Discrimination Argument

Gender discrimination is a relatively new argument avenue in the larger equal work, equal pay debate, said Joanne Spetz, PhD, director of the Institute for Health Policy Studies at the University of California, San Francisco.

“This is the first time I’ve heard of [such] a case being really gender discrimination focused,” she said in an interview. “On one level, I think it’s groundbreaking as a legal approach, but it’s also limited because it’s focused on public, state employees.”

Spetz noted that New York has significantly expanded NPs’ scope of practice, enacting in 2022 legislation that granted NPs full practice authority. The law means NPs can evaluate, order, diagnose, manage treatments, and prescribe medications for patients without physician supervision.

“They are in a role where they are stepping back and saying, ‘Wait, why are [we] not receiving equal pay for equal work?’ ” Spetz said. “It’s a totally fair area for debate, especially because they are now authorized to do essentially equal work with a high degree of autonomy.”
 

Debate Over Pay Grade

The nurses’ complaint centers on the New York State Civil Service Commission’s classification for NPs, which hasn’t changed since 2006. NPs are classified at grade 24, and they have no possibility of internal advancement associated with their title, according to the legal complaint filed on September 17.

To comply with a state legislative directive, the commission in 2018 conducted a study of the NP classification but recommended against reclassification or implementing a career ladder. The study noted the subordinate role of NPs to physicians and the substantial difference between physician classification (entry at grade 34) and that of NPs, psychologists (grade 25), and pharmacists (grade 25).

The study concluded that higher classified positions have higher levels of educational attainment and licensure requirements and no supervision or collaboration requirements, according to the complaint.

At the time, groups such as the Nurse Practitioner Association and the Public Employees Federation (PEF) criticized the findings, but the commission stuck to its classification.

Following the NP Modernization Act that allowed NPs to practice independently, PEF sought an increase for NPs to grade 28 with a progression to grade 34 depending on experience.

“But to this date, despite altering the starting salaries of NPs, defendants have failed and refused to alter the compensation offered to the substantial majority of NPs, and each plaintiff remains cabined in a grade 24 with a discriminatorily low salary when compared with males in other job classifications doing highly similar functions,” the lawsuit contended.

Six plaintiffs are named in the lawsuit, all of whom are women and work for state agencies. Plaintiff Rachel Burns, for instance, works as a psychiatric mental health NP in West Seneca and is responsible for performing psychiatric evaluations for patients, diagnosis, prescribing medication, ordering labs, and determining risks. The evaluations are identical for a psychiatrist and require her to complete the same forms, according to the suit.

Another plaintiff, Amber Hawthorne Lashway, works at a correctional facility in Altona, where for many years she was the sole medical provider, according to the lawsuit. Lashway’s duties, which include diagnoses and treatment of inmates’ medical conditions, mirror those performed by clinical physicians, the suit stated.

The plaintiffs are requesting the court accept jurisdiction of the matter and certify the class they seek to represent. They are also demanding prospective pay equity and compensatory damages for the distress caused by “the long-standing discriminatory” treatment by the state.

The Civil Service Commission and state of New York have not yet responded to the complaint. Their responses are due on November 12.
 

Attorney: Case Impact Limited

Benjamin McMichael, PhD, JD, said the New York case is not surprising as more states across the country are granting nurses more practice autonomy. The current landscape tends to favor the nurses, he said, with about half of states now allowing NPs full practice authority.

“I think the [New York] NPs are correct that they are underpaid,” said McMichael, an associate professor of law and director of the Interdisciplinary Legal Studies Initiative at The University of Alabama in Tuscaloosa. “With that said, the nature of the case does not clearly lend itself to national change.”

The fact that the NP plaintiffs are employed by the state means they are using a specific set of laws to advance their cause, he said. Other NPs in other employment situations may not have access to the same laws.
 

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

Over the past few years, many states have attempted to address the ongoing shortage of healthcare workers by introducing new bills to increase the scope of practice for nurse practitioners (NPs) and physician assistants (PAs). The goal of each bill was to improve access to care, particularly for patients who may live in areas where it’s difficult to find a doctor.

In response, the American Medical Association (AMA) launched a targeted campaign to fight “scope creep.” Their goal was to gain the momentum necessary to block proposed legislation to modify or expand the practice authority of nonphysicians, including PAs. A spokesperson for the organization told this news organization that the AMA “greatly values and respects the contributions of PAs as important members of the healthcare team” but emphasized that they do not have the same “skill set or breadth of experience of physicians.”

As such, the AMA argued that expanded practice authority would not only dismantle physician-led care teams but also ultimately lead to higher costs and lower-quality patient care.

The AMA has since launched a large-scale advocacy effort to fight practice expansion legislation — and has a specific page on its website to highlight those efforts. In addition, they have authored model legislation, talking points for AMA members, and a widely read article in AMA News to help them in what they call a “fight for physicians.”

These resources have also been disseminated to the greater healthcare stakeholder community.

Marilyn Suri, PA-C, chief operating officer and senior executive for Advanced Practice Professional Affairs at Vincenzo Novara MDPA and Associates, a critical care pulmonary medicine practice in Miami, Florida, said she found the AMA’s campaign to be “very misleading.”

“PAs are created in the image of physicians to help manage the physician shortage. We are trained very rigorously — to diagnose illness, develop treatment plans, and prescribe medications,” she said. “We’re not trying to expand our scope. We are trying to eliminate or lessen barriers that prevent patients from getting access to care.”

Suri is not alone. Last summer, the American Academy of Physician Associates (AAPA) requested a meeting with the AMA to find ways for the two organizations to collaborate to improve care delivery — as well as find common ground to address issues regarding patient access to care. When the AMA did not respond, the AAPA sent a second letter in September 2024, reiterating their request for a meeting.

That correspondence also included a letter, signed by more than 8000 PAs from across the country, calling for an end to what the AAPA refers to as “damaging rhetoric,” as well as data from a recent survey of PAs regarding the fallout of AMA’s scope creep messaging.

Those survey results highlighted that the vast majority of PAs surveyed feel that the AMA is doing more than just attacking proposed legislation: They believe the association is negatively influencing patients’ understanding of PA qualifications, ultimately affecting their ability to provide care.

“The campaign is unintentionally harming patients by suggesting we are doing more than what we are trained to do,” said Elisa Hock, PA-C, a behavioral health PA in Texas. “And when you work in a place with limited resources, medically speaking — including limited access to providers — this kind of campaign is really detrimental to helping patients.”

Lisa M. Gables, CEO of the AAPA, said the organization is “deeply disappointed” in the AMA’s lack of response to their letters thus far — but remains committed to working with the organization to bring forward new solutions to address healthcare’s most pressing challenges.

“AAPA remains committed to pushing for modernization of practice laws to ensure all providers can practice medicine to the fullest extent of their training, education, and experience,” she said. “That is what patients deserve and want.”

Hock agreed. She told this news organization that the public is not always aware of what PAs can offer in terms of patient care. That said, she believes newer generations of physicians understand the value of PAs and the many skills they bring to the table.

“I’ve been doing this for 17 years, and it’s been an uphill battle, at times, to educate the public about what PAs can and can’t do,” she explained. “To throw more mud in the mix that will confuse patients more about what we do doesn’t help. Healthcare works best with a team-based approach. And that team has been and always will be led by the physician. We are aware of our role and our limitations. But we also know what we can offer patients, especially in areas like El Paso, where there is a real shortage of providers.”

With a growing aging population — and the physician shortage expected to increase in the coming decade — Suri hopes that the AMA will accept AAPA’s invitation to meet — because no one wins with this kind of healthcare infighting. In fact, she said patients will suffer because of it. She hopes that future discussions and collaborations can show providers and patients what team-based healthcare can offer.

“I think it’s important for those in healthcare to be aware that none of us work alone. Even physicians collaborate with other subspecialties, as well as nurses and other healthcare professionals,” said Suri. “[Physicians and PAs] need to take a collaborative approach. We need each other. PAs are not physicians. But, just like physicians, we are considered safe and trusted care providers because of our education and training. And we can increase access to care for patients tomorrow if we start working together.”

A version of this article appeared on Medscape.com.

Over the past few years, many states have attempted to address the ongoing shortage of healthcare workers by introducing new bills to increase the scope of practice for nurse practitioners (NPs) and physician assistants (PAs). The goal of each bill was to improve access to care, particularly for patients who may live in areas where it’s difficult to find a doctor.

In response, the American Medical Association (AMA) launched a targeted campaign to fight “scope creep.” Their goal was to gain the momentum necessary to block proposed legislation to modify or expand the practice authority of nonphysicians, including PAs. A spokesperson for the organization told this news organization that the AMA “greatly values and respects the contributions of PAs as important members of the healthcare team” but emphasized that they do not have the same “skill set or breadth of experience of physicians.”

As such, the AMA argued that expanded practice authority would not only dismantle physician-led care teams but also ultimately lead to higher costs and lower-quality patient care.

The AMA has since launched a large-scale advocacy effort to fight practice expansion legislation — and has a specific page on its website to highlight those efforts. In addition, they have authored model legislation, talking points for AMA members, and a widely read article in AMA News to help them in what they call a “fight for physicians.”

These resources have also been disseminated to the greater healthcare stakeholder community.

Marilyn Suri, PA-C, chief operating officer and senior executive for Advanced Practice Professional Affairs at Vincenzo Novara MDPA and Associates, a critical care pulmonary medicine practice in Miami, Florida, said she found the AMA’s campaign to be “very misleading.”

“PAs are created in the image of physicians to help manage the physician shortage. We are trained very rigorously — to diagnose illness, develop treatment plans, and prescribe medications,” she said. “We’re not trying to expand our scope. We are trying to eliminate or lessen barriers that prevent patients from getting access to care.”

Suri is not alone. Last summer, the American Academy of Physician Associates (AAPA) requested a meeting with the AMA to find ways for the two organizations to collaborate to improve care delivery — as well as find common ground to address issues regarding patient access to care. When the AMA did not respond, the AAPA sent a second letter in September 2024, reiterating their request for a meeting.

That correspondence also included a letter, signed by more than 8000 PAs from across the country, calling for an end to what the AAPA refers to as “damaging rhetoric,” as well as data from a recent survey of PAs regarding the fallout of AMA’s scope creep messaging.

Those survey results highlighted that the vast majority of PAs surveyed feel that the AMA is doing more than just attacking proposed legislation: They believe the association is negatively influencing patients’ understanding of PA qualifications, ultimately affecting their ability to provide care.

“The campaign is unintentionally harming patients by suggesting we are doing more than what we are trained to do,” said Elisa Hock, PA-C, a behavioral health PA in Texas. “And when you work in a place with limited resources, medically speaking — including limited access to providers — this kind of campaign is really detrimental to helping patients.”

Lisa M. Gables, CEO of the AAPA, said the organization is “deeply disappointed” in the AMA’s lack of response to their letters thus far — but remains committed to working with the organization to bring forward new solutions to address healthcare’s most pressing challenges.

“AAPA remains committed to pushing for modernization of practice laws to ensure all providers can practice medicine to the fullest extent of their training, education, and experience,” she said. “That is what patients deserve and want.”

Hock agreed. She told this news organization that the public is not always aware of what PAs can offer in terms of patient care. That said, she believes newer generations of physicians understand the value of PAs and the many skills they bring to the table.

“I’ve been doing this for 17 years, and it’s been an uphill battle, at times, to educate the public about what PAs can and can’t do,” she explained. “To throw more mud in the mix that will confuse patients more about what we do doesn’t help. Healthcare works best with a team-based approach. And that team has been and always will be led by the physician. We are aware of our role and our limitations. But we also know what we can offer patients, especially in areas like El Paso, where there is a real shortage of providers.”

With a growing aging population — and the physician shortage expected to increase in the coming decade — Suri hopes that the AMA will accept AAPA’s invitation to meet — because no one wins with this kind of healthcare infighting. In fact, she said patients will suffer because of it. She hopes that future discussions and collaborations can show providers and patients what team-based healthcare can offer.

“I think it’s important for those in healthcare to be aware that none of us work alone. Even physicians collaborate with other subspecialties, as well as nurses and other healthcare professionals,” said Suri. “[Physicians and PAs] need to take a collaborative approach. We need each other. PAs are not physicians. But, just like physicians, we are considered safe and trusted care providers because of our education and training. And we can increase access to care for patients tomorrow if we start working together.”

A version of this article appeared on Medscape.com.

Over the past few years, many states have attempted to address the ongoing shortage of healthcare workers by introducing new bills to increase the scope of practice for nurse practitioners (NPs) and physician assistants (PAs). The goal of each bill was to improve access to care, particularly for patients who may live in areas where it’s difficult to find a doctor.

In response, the American Medical Association (AMA) launched a targeted campaign to fight “scope creep.” Their goal was to gain the momentum necessary to block proposed legislation to modify or expand the practice authority of nonphysicians, including PAs. A spokesperson for the organization told this news organization that the AMA “greatly values and respects the contributions of PAs as important members of the healthcare team” but emphasized that they do not have the same “skill set or breadth of experience of physicians.”

As such, the AMA argued that expanded practice authority would not only dismantle physician-led care teams but also ultimately lead to higher costs and lower-quality patient care.

The AMA has since launched a large-scale advocacy effort to fight practice expansion legislation — and has a specific page on its website to highlight those efforts. In addition, they have authored model legislation, talking points for AMA members, and a widely read article in AMA News to help them in what they call a “fight for physicians.”

These resources have also been disseminated to the greater healthcare stakeholder community.

Marilyn Suri, PA-C, chief operating officer and senior executive for Advanced Practice Professional Affairs at Vincenzo Novara MDPA and Associates, a critical care pulmonary medicine practice in Miami, Florida, said she found the AMA’s campaign to be “very misleading.”

“PAs are created in the image of physicians to help manage the physician shortage. We are trained very rigorously — to diagnose illness, develop treatment plans, and prescribe medications,” she said. “We’re not trying to expand our scope. We are trying to eliminate or lessen barriers that prevent patients from getting access to care.”

Suri is not alone. Last summer, the American Academy of Physician Associates (AAPA) requested a meeting with the AMA to find ways for the two organizations to collaborate to improve care delivery — as well as find common ground to address issues regarding patient access to care. When the AMA did not respond, the AAPA sent a second letter in September 2024, reiterating their request for a meeting.

That correspondence also included a letter, signed by more than 8000 PAs from across the country, calling for an end to what the AAPA refers to as “damaging rhetoric,” as well as data from a recent survey of PAs regarding the fallout of AMA’s scope creep messaging.

Those survey results highlighted that the vast majority of PAs surveyed feel that the AMA is doing more than just attacking proposed legislation: They believe the association is negatively influencing patients’ understanding of PA qualifications, ultimately affecting their ability to provide care.

“The campaign is unintentionally harming patients by suggesting we are doing more than what we are trained to do,” said Elisa Hock, PA-C, a behavioral health PA in Texas. “And when you work in a place with limited resources, medically speaking — including limited access to providers — this kind of campaign is really detrimental to helping patients.”

Lisa M. Gables, CEO of the AAPA, said the organization is “deeply disappointed” in the AMA’s lack of response to their letters thus far — but remains committed to working with the organization to bring forward new solutions to address healthcare’s most pressing challenges.

“AAPA remains committed to pushing for modernization of practice laws to ensure all providers can practice medicine to the fullest extent of their training, education, and experience,” she said. “That is what patients deserve and want.”

Hock agreed. She told this news organization that the public is not always aware of what PAs can offer in terms of patient care. That said, she believes newer generations of physicians understand the value of PAs and the many skills they bring to the table.

“I’ve been doing this for 17 years, and it’s been an uphill battle, at times, to educate the public about what PAs can and can’t do,” she explained. “To throw more mud in the mix that will confuse patients more about what we do doesn’t help. Healthcare works best with a team-based approach. And that team has been and always will be led by the physician. We are aware of our role and our limitations. But we also know what we can offer patients, especially in areas like El Paso, where there is a real shortage of providers.”

With a growing aging population — and the physician shortage expected to increase in the coming decade — Suri hopes that the AMA will accept AAPA’s invitation to meet — because no one wins with this kind of healthcare infighting. In fact, she said patients will suffer because of it. She hopes that future discussions and collaborations can show providers and patients what team-based healthcare can offer.

“I think it’s important for those in healthcare to be aware that none of us work alone. Even physicians collaborate with other subspecialties, as well as nurses and other healthcare professionals,” said Suri. “[Physicians and PAs] need to take a collaborative approach. We need each other. PAs are not physicians. But, just like physicians, we are considered safe and trusted care providers because of our education and training. And we can increase access to care for patients tomorrow if we start working together.”

A version of this article appeared on Medscape.com.

Editor’s Note: Sadly, this is the last column in the Master Class Obstetrics series. This award-winning column has been part of Ob.Gyn. News for 20 years. The deep discussion of cutting-edge topics in obstetrics by specialists and researchers will be missed as will the leadership and curation of topics by Dr. E. Albert Reece.
 

Introduction: The Need for Increased Vigilance About Maternal Immunization

Viruses are becoming increasingly prevalent in our world and the consequences of viral infections are implicated in a growing number of disease states. It is well established that certain cancers are caused by viruses and it is increasingly evident that viral infections can trigger the development of chronic illness. In pregnant women, viruses such as cytomegalovirus can cause infection in utero and lead to long-term impairments for the baby.

Likewise, it appears that the virulence of viruses is increasing, whether it be the respiratory syncytial virus (RSV) in children or the severe acute respiratory syndrome (SARS) coronaviruses in adults. Clearly, our environment is changing, with increases in population growth and urbanization, for instance, and an intensification of climate change and its effects. Viruses are part of this changing background.

Dr. Reece is the former Dean of Medicine & University Executive VP, and The Distinguished University and Endowed Professor & Director of the Center for Advanced Research Training and Innovation (CARTI) at the University of Maryland School of Medicine, as well as senior scientist at the Center for Birth Defects Research.

The alarming decline in maternal immunization rates that occurred in the wake of the COVID-19 pandemic means that, now more than ever, we must fully embrace our responsibility to recommend immunizations in pregnancy and to communicate what is known about their efficacy and safety. Data show that vaccination rates drop when we do not offer vaccines in our offices, so whenever possible, we should administer them as well.

The ob.gyn. is the patient’s most trusted person in pregnancy. When patients decline or express hesitancy about vaccines, it is incumbent upon us to ask why. Oftentimes, we can identify areas in which patients lack knowledge or have misperceptions and we can successfully educate the patient or change their perspective or misunderstanding concerning the importance of vaccination for themselves and their babies. (See Table 1.) We can also successfully address concerns about safety.

Dr. Riley

New York Presbyterian

Counseling About Influenza and COVID-19 Vaccination

The COVID-19 pandemic took a toll on vaccination interest/receptivity broadly in pregnant and nonpregnant people. Among pregnant individuals, influenza vaccination coverage declined from 71% in the 2019-2020 influenza season to 56% in the 2021-2022 season, according to data from the Centers for Disease Control and Prevention’s Vaccine Safety Datalink.⁴ Coverage for the 2022-2023 and 2023-2024 influenza seasons was even worse: well under 50%.⁵

Fewer pregnant women have received updated COVID-19 vaccines. Only 13% of pregnant persons overall received the updated 2023-2024 COVID-19 booster vaccine (through March 30, 2024), according to the CDC.⁶

Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), and flu vaccines have been given to millions of pregnant women, but the H1N1 pandemic of 2009 reinforced its value as a priority for prenatal care. Most of the women who became severely ill from the H1N1 virus were young and healthy, without co-existing conditions known to increase risk.⁷

It became clearer during the H1N1 pandemic that pregnancy itself — which is associated with physiologic changes such as decreased lung capacity, increased nasal congestion and changes in the immune system – is its own significant risk factor for severe illness from the influenza virus. This increased risk applies to COVID-19 as well.

As COVID-19 has become endemic, with hospitalizations and deaths not reaching the levels of previous surges — and with mask-wearing and other preventive measures having declined — patients understandably have become more complacent. Some patients are vaccine deniers, but in my practice, these patients are a much smaller group than those who believe COVID-19 “is no big deal,” especially if they have had infections recently.

This is why it’s important to actively listen to concerns and to ask patients who decline a vaccination why they are hesitant. Blanket messages about vaccine efficacy and safety are the first step, but individualized, more pointed conversations based on the patient’s personal experiences and beliefs have become increasingly important.

I routinely tell pregnant patients about the risks of COVID-19 and I explain that it has been difficult to predict who will develop severe illness. Sometimes more conversation is needed. For those who are still hesitant or who tell me they feel protected by a recent infection, for instance, I provide more detail on the unique risks of pregnancy — the fact that “pregnancy is different” — and that natural immunity wanes while the protection afforded by immunization is believed to last longer. Many women are also concerned about the safety of the COVID-19 vaccine, so having safety data at your fingertips is helpful. (See Table 2.)

Dr. Riley

Counseling About RSV Vaccination

Importantly, for the 2024-2025 RSV season, the maternal RSV vaccine (Abrysvo, Pfizer) is recommended only for pregnant women who did not receive the vaccine during the 2023-2024 season. When more research is done and more data are obtained showing how long the immune response persists post vaccination, it may be that the US Food and Drug Administration (FDA) will approve the maternal RSV vaccine for use in every pregnancy.

The later timing of the vaccination recommendation — 32-36 weeks’ gestation — reflects a conservative approach taken by the FDA in response to data from one of the pivotal trials showing a numerical trend toward more preterm deliveries among vaccinated compared with unvaccinated patients. This imbalance in the original trial, which administered the vaccine during 24-36 weeks of gestation, was seen only in low-income countries with no temporal association, however.

In our experience at two Weill Cornell Medical College–associated hospitals we did not see this trend. Our cohort study of almost 3000 pregnant patients who delivered at 32 weeks’ gestation or later found no increased risk of preterm birth among the 35% of patients who received the RSV vaccine during the 2023-2024 RSV season. We also did not see any difference in preeclampsia, in contrast with original trial data that showed a signal for increased risk.¹¹

When fewer than 2 weeks have elapsed between maternal vaccination and delivery, the monoclonal antibody nirsevimab is recommended for the newborn — ideally before the newborn leaves the hospital. Nirsevimab is also recommended for newborns of mothers who decline vaccination or were not candidates (e.g. vaccinated in a previous pregnancy), or when there is concern about the adequacy of the maternal immune response to the vaccine (e.g. in cases of immunosuppression).

While there was a limited supply of the monoclonal antibody last year, limitations are not expected this year, especially after October.

The ultimate goal is that patients choose the vaccine or the immunoglobulin, given the severity of RSV disease. Patient preferences should be considered. However, given that it takes 2 weeks after vaccination for protection to build up, I stress to patients that if they’ve vaccinated themselves, their newborn will leave the hospital with protection. If nirsevimab is relied upon, I explain, their newborn may not be protected for some period of time.
 

Take-home Messages

• When patients decline or are hesitant about vaccines, ask why. Listen actively, and work to correct misperceptions and knowledge gaps.
• Whenever possible, offer vaccines in your practice. Vaccination rates drop when this does not occur.
• COVID-vaccine safety is backed by many studies showing no increase in birth defects, preterm delivery, miscarriage, or stillbirth.
• Pregnant women are more likely to have severe illness from the influenza and SARS-CoV-2 viruses. Vaccines can prevent severe illness and can protect the newborn as well as the mother.
• Recommend/administer the maternal RSV vaccine at 32-36 weeks’ gestation in women who did not receive the vaccine in the 2023-2024 season. If mothers aren’t eligible their babies should be offered nirsevimab.

Dr. Riley is the Given Foundation Professor and Chair of Obstetrics and Gynecology at Weill Cornell Medicine and the obstetrician and gynecologist-in-chief at New York Presbyterian Hospital. She disclosed that she has provided one-time consultations to Pfizer (Abrysvo RSV vaccine) and GSK (cytomegalovirus vaccine), and is providing consultant education on CMV for Moderna. She is chair of ACOG’s task force on immunization and emerging infectious diseases, serves on the medical advisory board for MAVEN, and serves as an editor or editorial board member for several medical publications.



References

1. ACOG Committee Opinion No. 741: Maternal Immunization. Obstet Gynecol. 2018;131(6):e214-e217.

2. Centers for Disease Control and Prevention. COVID-19 Vaccination for People Who are Pregnant or Breastfeeding. https://www.cdc.gov/covid/vaccines/pregnant-or-breastfeeding.html.

3. ACOG Practice Advisory on Maternal Respiratory Syncytial Virus Vaccination, September 2023. (Updated August 2024).4. Irving S et al. Open Forum Infect Dis. 2023;10(Suppl 2):ofad500.1002.

5. Flu Vaccination Dashboard, CDC, National Center for Immunization and Respiratory Diseases.

6. Weekly COVID-19 Vaccination Dashboard, CDC. https://www.cdc.gov/covidvaxview/weekly-dashboard/index.html

7. Louie JK et al. N Engl J Med. 2010;362:27-35. 8. Ciapponi A et al. Vaccine. 2021;39(40):5891-908.

9. Prasad S et al. Nature Communications. 2022;13:2414. 10. Fleming-Dutra KE et al. Obstet Gynecol Clin North Am 2023;50(2):279-97. 11. Mouen S et al. JAMA Network Open 2024;7(7):e2419268.

Editor’s Note: Sadly, this is the last column in the Master Class Obstetrics series. This award-winning column has been part of Ob.Gyn. News for 20 years. The deep discussion of cutting-edge topics in obstetrics by specialists and researchers will be missed as will the leadership and curation of topics by Dr. E. Albert Reece.
 

Introduction: The Need for Increased Vigilance About Maternal Immunization

Viruses are becoming increasingly prevalent in our world and the consequences of viral infections are implicated in a growing number of disease states. It is well established that certain cancers are caused by viruses and it is increasingly evident that viral infections can trigger the development of chronic illness. In pregnant women, viruses such as cytomegalovirus can cause infection in utero and lead to long-term impairments for the baby.

Likewise, it appears that the virulence of viruses is increasing, whether it be the respiratory syncytial virus (RSV) in children or the severe acute respiratory syndrome (SARS) coronaviruses in adults. Clearly, our environment is changing, with increases in population growth and urbanization, for instance, and an intensification of climate change and its effects. Viruses are part of this changing background.

Dr. Reece is the former Dean of Medicine & University Executive VP, and The Distinguished University and Endowed Professor & Director of the Center for Advanced Research Training and Innovation (CARTI) at the University of Maryland School of Medicine, as well as senior scientist at the Center for Birth Defects Research.

The alarming decline in maternal immunization rates that occurred in the wake of the COVID-19 pandemic means that, now more than ever, we must fully embrace our responsibility to recommend immunizations in pregnancy and to communicate what is known about their efficacy and safety. Data show that vaccination rates drop when we do not offer vaccines in our offices, so whenever possible, we should administer them as well.

The ob.gyn. is the patient’s most trusted person in pregnancy. When patients decline or express hesitancy about vaccines, it is incumbent upon us to ask why. Oftentimes, we can identify areas in which patients lack knowledge or have misperceptions and we can successfully educate the patient or change their perspective or misunderstanding concerning the importance of vaccination for themselves and their babies. (See Table 1.) We can also successfully address concerns about safety.

Dr. Riley

New York Presbyterian

Counseling About Influenza and COVID-19 Vaccination

The COVID-19 pandemic took a toll on vaccination interest/receptivity broadly in pregnant and nonpregnant people. Among pregnant individuals, influenza vaccination coverage declined from 71% in the 2019-2020 influenza season to 56% in the 2021-2022 season, according to data from the Centers for Disease Control and Prevention’s Vaccine Safety Datalink.⁴ Coverage for the 2022-2023 and 2023-2024 influenza seasons was even worse: well under 50%.⁵

Fewer pregnant women have received updated COVID-19 vaccines. Only 13% of pregnant persons overall received the updated 2023-2024 COVID-19 booster vaccine (through March 30, 2024), according to the CDC.⁶

Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), and flu vaccines have been given to millions of pregnant women, but the H1N1 pandemic of 2009 reinforced its value as a priority for prenatal care. Most of the women who became severely ill from the H1N1 virus were young and healthy, without co-existing conditions known to increase risk.⁷

It became clearer during the H1N1 pandemic that pregnancy itself — which is associated with physiologic changes such as decreased lung capacity, increased nasal congestion and changes in the immune system – is its own significant risk factor for severe illness from the influenza virus. This increased risk applies to COVID-19 as well.

As COVID-19 has become endemic, with hospitalizations and deaths not reaching the levels of previous surges — and with mask-wearing and other preventive measures having declined — patients understandably have become more complacent. Some patients are vaccine deniers, but in my practice, these patients are a much smaller group than those who believe COVID-19 “is no big deal,” especially if they have had infections recently.

This is why it’s important to actively listen to concerns and to ask patients who decline a vaccination why they are hesitant. Blanket messages about vaccine efficacy and safety are the first step, but individualized, more pointed conversations based on the patient’s personal experiences and beliefs have become increasingly important.

I routinely tell pregnant patients about the risks of COVID-19 and I explain that it has been difficult to predict who will develop severe illness. Sometimes more conversation is needed. For those who are still hesitant or who tell me they feel protected by a recent infection, for instance, I provide more detail on the unique risks of pregnancy — the fact that “pregnancy is different” — and that natural immunity wanes while the protection afforded by immunization is believed to last longer. Many women are also concerned about the safety of the COVID-19 vaccine, so having safety data at your fingertips is helpful. (See Table 2.)

Dr. Riley

Counseling About RSV Vaccination

Importantly, for the 2024-2025 RSV season, the maternal RSV vaccine (Abrysvo, Pfizer) is recommended only for pregnant women who did not receive the vaccine during the 2023-2024 season. When more research is done and more data are obtained showing how long the immune response persists post vaccination, it may be that the US Food and Drug Administration (FDA) will approve the maternal RSV vaccine for use in every pregnancy.

The later timing of the vaccination recommendation — 32-36 weeks’ gestation — reflects a conservative approach taken by the FDA in response to data from one of the pivotal trials showing a numerical trend toward more preterm deliveries among vaccinated compared with unvaccinated patients. This imbalance in the original trial, which administered the vaccine during 24-36 weeks of gestation, was seen only in low-income countries with no temporal association, however.

In our experience at two Weill Cornell Medical College–associated hospitals we did not see this trend. Our cohort study of almost 3000 pregnant patients who delivered at 32 weeks’ gestation or later found no increased risk of preterm birth among the 35% of patients who received the RSV vaccine during the 2023-2024 RSV season. We also did not see any difference in preeclampsia, in contrast with original trial data that showed a signal for increased risk.¹¹

When fewer than 2 weeks have elapsed between maternal vaccination and delivery, the monoclonal antibody nirsevimab is recommended for the newborn — ideally before the newborn leaves the hospital. Nirsevimab is also recommended for newborns of mothers who decline vaccination or were not candidates (e.g. vaccinated in a previous pregnancy), or when there is concern about the adequacy of the maternal immune response to the vaccine (e.g. in cases of immunosuppression).

While there was a limited supply of the monoclonal antibody last year, limitations are not expected this year, especially after October.

The ultimate goal is that patients choose the vaccine or the immunoglobulin, given the severity of RSV disease. Patient preferences should be considered. However, given that it takes 2 weeks after vaccination for protection to build up, I stress to patients that if they’ve vaccinated themselves, their newborn will leave the hospital with protection. If nirsevimab is relied upon, I explain, their newborn may not be protected for some period of time.
 

Take-home Messages

• When patients decline or are hesitant about vaccines, ask why. Listen actively, and work to correct misperceptions and knowledge gaps.
• Whenever possible, offer vaccines in your practice. Vaccination rates drop when this does not occur.
• COVID-vaccine safety is backed by many studies showing no increase in birth defects, preterm delivery, miscarriage, or stillbirth.
• Pregnant women are more likely to have severe illness from the influenza and SARS-CoV-2 viruses. Vaccines can prevent severe illness and can protect the newborn as well as the mother.
• Recommend/administer the maternal RSV vaccine at 32-36 weeks’ gestation in women who did not receive the vaccine in the 2023-2024 season. If mothers aren’t eligible their babies should be offered nirsevimab.

Dr. Riley is the Given Foundation Professor and Chair of Obstetrics and Gynecology at Weill Cornell Medicine and the obstetrician and gynecologist-in-chief at New York Presbyterian Hospital. She disclosed that she has provided one-time consultations to Pfizer (Abrysvo RSV vaccine) and GSK (cytomegalovirus vaccine), and is providing consultant education on CMV for Moderna. She is chair of ACOG’s task force on immunization and emerging infectious diseases, serves on the medical advisory board for MAVEN, and serves as an editor or editorial board member for several medical publications.



References

1. ACOG Committee Opinion No. 741: Maternal Immunization. Obstet Gynecol. 2018;131(6):e214-e217.

2. Centers for Disease Control and Prevention. COVID-19 Vaccination for People Who are Pregnant or Breastfeeding. https://www.cdc.gov/covid/vaccines/pregnant-or-breastfeeding.html.

3. ACOG Practice Advisory on Maternal Respiratory Syncytial Virus Vaccination, September 2023. (Updated August 2024).4. Irving S et al. Open Forum Infect Dis. 2023;10(Suppl 2):ofad500.1002.

5. Flu Vaccination Dashboard, CDC, National Center for Immunization and Respiratory Diseases.

6. Weekly COVID-19 Vaccination Dashboard, CDC. https://www.cdc.gov/covidvaxview/weekly-dashboard/index.html

7. Louie JK et al. N Engl J Med. 2010;362:27-35. 8. Ciapponi A et al. Vaccine. 2021;39(40):5891-908.

9. Prasad S et al. Nature Communications. 2022;13:2414. 10. Fleming-Dutra KE et al. Obstet Gynecol Clin North Am 2023;50(2):279-97. 11. Mouen S et al. JAMA Network Open 2024;7(7):e2419268.

Editor’s Note: Sadly, this is the last column in the Master Class Obstetrics series. This award-winning column has been part of Ob.Gyn. News for 20 years. The deep discussion of cutting-edge topics in obstetrics by specialists and researchers will be missed as will the leadership and curation of topics by Dr. E. Albert Reece.
 

Introduction: The Need for Increased Vigilance About Maternal Immunization

Viruses are becoming increasingly prevalent in our world and the consequences of viral infections are implicated in a growing number of disease states. It is well established that certain cancers are caused by viruses and it is increasingly evident that viral infections can trigger the development of chronic illness. In pregnant women, viruses such as cytomegalovirus can cause infection in utero and lead to long-term impairments for the baby.

Likewise, it appears that the virulence of viruses is increasing, whether it be the respiratory syncytial virus (RSV) in children or the severe acute respiratory syndrome (SARS) coronaviruses in adults. Clearly, our environment is changing, with increases in population growth and urbanization, for instance, and an intensification of climate change and its effects. Viruses are part of this changing background.

Dr. Reece is the former Dean of Medicine & University Executive VP, and The Distinguished University and Endowed Professor & Director of the Center for Advanced Research Training and Innovation (CARTI) at the University of Maryland School of Medicine, as well as senior scientist at the Center for Birth Defects Research.

The alarming decline in maternal immunization rates that occurred in the wake of the COVID-19 pandemic means that, now more than ever, we must fully embrace our responsibility to recommend immunizations in pregnancy and to communicate what is known about their efficacy and safety. Data show that vaccination rates drop when we do not offer vaccines in our offices, so whenever possible, we should administer them as well.

The ob.gyn. is the patient’s most trusted person in pregnancy. When patients decline or express hesitancy about vaccines, it is incumbent upon us to ask why. Oftentimes, we can identify areas in which patients lack knowledge or have misperceptions and we can successfully educate the patient or change their perspective or misunderstanding concerning the importance of vaccination for themselves and their babies. (See Table 1.) We can also successfully address concerns about safety.

Dr. Riley

New York Presbyterian

Counseling About Influenza and COVID-19 Vaccination

The COVID-19 pandemic took a toll on vaccination interest/receptivity broadly in pregnant and nonpregnant people. Among pregnant individuals, influenza vaccination coverage declined from 71% in the 2019-2020 influenza season to 56% in the 2021-2022 season, according to data from the Centers for Disease Control and Prevention’s Vaccine Safety Datalink.⁴ Coverage for the 2022-2023 and 2023-2024 influenza seasons was even worse: well under 50%.⁵

Fewer pregnant women have received updated COVID-19 vaccines. Only 13% of pregnant persons overall received the updated 2023-2024 COVID-19 booster vaccine (through March 30, 2024), according to the CDC.⁶

Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), and flu vaccines have been given to millions of pregnant women, but the H1N1 pandemic of 2009 reinforced its value as a priority for prenatal care. Most of the women who became severely ill from the H1N1 virus were young and healthy, without co-existing conditions known to increase risk.⁷

It became clearer during the H1N1 pandemic that pregnancy itself — which is associated with physiologic changes such as decreased lung capacity, increased nasal congestion and changes in the immune system – is its own significant risk factor for severe illness from the influenza virus. This increased risk applies to COVID-19 as well.

As COVID-19 has become endemic, with hospitalizations and deaths not reaching the levels of previous surges — and with mask-wearing and other preventive measures having declined — patients understandably have become more complacent. Some patients are vaccine deniers, but in my practice, these patients are a much smaller group than those who believe COVID-19 “is no big deal,” especially if they have had infections recently.

This is why it’s important to actively listen to concerns and to ask patients who decline a vaccination why they are hesitant. Blanket messages about vaccine efficacy and safety are the first step, but individualized, more pointed conversations based on the patient’s personal experiences and beliefs have become increasingly important.

I routinely tell pregnant patients about the risks of COVID-19 and I explain that it has been difficult to predict who will develop severe illness. Sometimes more conversation is needed. For those who are still hesitant or who tell me they feel protected by a recent infection, for instance, I provide more detail on the unique risks of pregnancy — the fact that “pregnancy is different” — and that natural immunity wanes while the protection afforded by immunization is believed to last longer. Many women are also concerned about the safety of the COVID-19 vaccine, so having safety data at your fingertips is helpful. (See Table 2.)

Dr. Riley

Counseling About RSV Vaccination

Importantly, for the 2024-2025 RSV season, the maternal RSV vaccine (Abrysvo, Pfizer) is recommended only for pregnant women who did not receive the vaccine during the 2023-2024 season. When more research is done and more data are obtained showing how long the immune response persists post vaccination, it may be that the US Food and Drug Administration (FDA) will approve the maternal RSV vaccine for use in every pregnancy.

The later timing of the vaccination recommendation — 32-36 weeks’ gestation — reflects a conservative approach taken by the FDA in response to data from one of the pivotal trials showing a numerical trend toward more preterm deliveries among vaccinated compared with unvaccinated patients. This imbalance in the original trial, which administered the vaccine during 24-36 weeks of gestation, was seen only in low-income countries with no temporal association, however.

In our experience at two Weill Cornell Medical College–associated hospitals we did not see this trend. Our cohort study of almost 3000 pregnant patients who delivered at 32 weeks’ gestation or later found no increased risk of preterm birth among the 35% of patients who received the RSV vaccine during the 2023-2024 RSV season. We also did not see any difference in preeclampsia, in contrast with original trial data that showed a signal for increased risk.¹¹

When fewer than 2 weeks have elapsed between maternal vaccination and delivery, the monoclonal antibody nirsevimab is recommended for the newborn — ideally before the newborn leaves the hospital. Nirsevimab is also recommended for newborns of mothers who decline vaccination or were not candidates (e.g. vaccinated in a previous pregnancy), or when there is concern about the adequacy of the maternal immune response to the vaccine (e.g. in cases of immunosuppression).

While there was a limited supply of the monoclonal antibody last year, limitations are not expected this year, especially after October.

The ultimate goal is that patients choose the vaccine or the immunoglobulin, given the severity of RSV disease. Patient preferences should be considered. However, given that it takes 2 weeks after vaccination for protection to build up, I stress to patients that if they’ve vaccinated themselves, their newborn will leave the hospital with protection. If nirsevimab is relied upon, I explain, their newborn may not be protected for some period of time.
 

Take-home Messages

• When patients decline or are hesitant about vaccines, ask why. Listen actively, and work to correct misperceptions and knowledge gaps.
• Whenever possible, offer vaccines in your practice. Vaccination rates drop when this does not occur.
• COVID-vaccine safety is backed by many studies showing no increase in birth defects, preterm delivery, miscarriage, or stillbirth.
• Pregnant women are more likely to have severe illness from the influenza and SARS-CoV-2 viruses. Vaccines can prevent severe illness and can protect the newborn as well as the mother.
• Recommend/administer the maternal RSV vaccine at 32-36 weeks’ gestation in women who did not receive the vaccine in the 2023-2024 season. If mothers aren’t eligible their babies should be offered nirsevimab.

Dr. Riley is the Given Foundation Professor and Chair of Obstetrics and Gynecology at Weill Cornell Medicine and the obstetrician and gynecologist-in-chief at New York Presbyterian Hospital. She disclosed that she has provided one-time consultations to Pfizer (Abrysvo RSV vaccine) and GSK (cytomegalovirus vaccine), and is providing consultant education on CMV for Moderna. She is chair of ACOG’s task force on immunization and emerging infectious diseases, serves on the medical advisory board for MAVEN, and serves as an editor or editorial board member for several medical publications.



References

1. ACOG Committee Opinion No. 741: Maternal Immunization. Obstet Gynecol. 2018;131(6):e214-e217.

2. Centers for Disease Control and Prevention. COVID-19 Vaccination for People Who are Pregnant or Breastfeeding. https://www.cdc.gov/covid/vaccines/pregnant-or-breastfeeding.html.

3. ACOG Practice Advisory on Maternal Respiratory Syncytial Virus Vaccination, September 2023. (Updated August 2024).4. Irving S et al. Open Forum Infect Dis. 2023;10(Suppl 2):ofad500.1002.

5. Flu Vaccination Dashboard, CDC, National Center for Immunization and Respiratory Diseases.

6. Weekly COVID-19 Vaccination Dashboard, CDC. https://www.cdc.gov/covidvaxview/weekly-dashboard/index.html

7. Louie JK et al. N Engl J Med. 2010;362:27-35. 8. Ciapponi A et al. Vaccine. 2021;39(40):5891-908.

9. Prasad S et al. Nature Communications. 2022;13:2414. 10. Fleming-Dutra KE et al. Obstet Gynecol Clin North Am 2023;50(2):279-97. 11. Mouen S et al. JAMA Network Open 2024;7(7):e2419268.

Thanks to the continuously improving treatment options for cancer, the number of cancer survivors is increasing, and a large proportion of survivors is confronted with the long-term effects of cancer treatment. Especially for young patients, the question of the impact of therapy on fertility arises.

Dose adjustment or modification of the treatment regimen can achieve a lot. But experts at the congress of the European Society for Medical Oncology (ESMO) 2024 noted that knowledge about newer treatment options like immunotherapies is still insufficient.
 

Therapy Selection

The question of preserving fertility must be considered when deciding on the appropriate treatment, said Matteo Lambertini, MD, PhD, medical oncology consultant at the University of Genoa in Genoa, Italy. A patient’s age, the type of therapy, and the dose are crucial in determining whether or how much fertility is affected. “Preserving fertility is also an aim of cancer therapy,” he said.

Lambertini, who is also a member of the ESMO Guideline Group on fertility preservation in cancer patients, referred to the 2020 ESMO guidelines, which list the gonadotoxicity of a substance depending on the treatment regimen and the patient’s age.

Isabelle Demeestere, MD, PhD, director of the research lab for human reproduction at the Erasmus Hospital of the Free University of Brussels in Brussels, Belgium, pointed out the limitations of general guidelines. “Therapies change over time, and a classification must be updated regularly.”

Knowledge gaps related to well-known therapies and many novel options persist. “For many FDA-approved medications, there are either no fertility data or only preclinical data available,” she added.
 

Chemotherapies and Immunotherapies

Chemotherapies with alkylating or platinum-containing substances are known for their effects on oocytes, follicle maturation, and spermatogenesis, said Demeestere.

Chemotherapy is gonadotoxic and leads to a temporary decrease in sperm quality or temporary azoospermia in men.

These effects, however, can lead to permanent azoospermia and endocrine disorders, depending on the dose, duration, or combination with radiation, said Demeestere.

Cryopreservation of sperm should always be performed before starting treatment. For high-risk patients who are prepubertal, samples of testicular tissue are taken.

In women, chemotherapy affects primordial follicles and follicle maturation through DNA damage. This process results in severe or temporary amenorrhea, a temporary or permanent decrease in egg reserve, and ultimately premature egg insufficiency.

Novel immunotherapies also influence fertility, presumably through interactions of the immune system with the reproductive organs. But insufficient data are available, according to Lambertini, who emphasized that “these data are urgently needed, especially for young patients with cancer.”

In a mouse model, immune checkpoint inhibitors affected ovarian function, and the inflammatory reaction in humans can affect fertility. No long-term data are available for women yet, however, explained Demeestere. The effects of other therapeutics such as PARP, CDK4/6, or tyrosine kinase inhibitors, as well as monoclonal antibodies like trastuzumab, are only seen sporadically.

In the PENELOPE-B phase 3 study, the CDK4/6 inhibitor palbociclib did not affect ovarian function, even though the cyclin-dependent kinases play an important role in mitotic arrest, said Demeestere.
 

Adjusting the Regimen

In a PET-guided approach, Demeestere’s research team investigated the effects of dose reduction or adjustment of the treatment regimen of procarbazine and cyclophosphamide on the fertility of patients younger than 45 years with advanced Hodgkin lymphoma.

By regularly controlling tumor growth with PET, the treatment could be adjusted so that the effect on egg reserve or spermatogenesis was significantly reduced and loss of fertility could be prevented.

During the 5-year follow-up period, the ovarian function of participating women was assessed by the serum concentration of follicle-stimulating hormone (FSH), estradiol, and anti-Müllerian hormone (AMH) to evaluate egg reserve. In men, testicular function was assessed at the beginning of the study. At the end of treatment, sperm analysis and FSH and testosterone levels were checked.

Demeestere and colleagues demonstrated that dose reduction or altering the treatment regimen for patients who responded early to treatment (determined by PET-guided monitoring) reduced the risk for gonadotoxicity from 46% to 14.5%. That is, the risk was reduced by more than half.

FSH and AMH correlated with the patient’s age and the dose of the alkylating agent. In men, sperm parameters recovered after dose or agent adjustment compared with the unchanged treatment regimen.

Newer results from the PHERGain study in women with early human epidermal growth factor receptor 2–positive breast cancer also provided hope, according to Demeestere. Under PET-guided control, chemotherapy could be reduced.
 

More Data Needed

The new treatment options pose a challenge to preserving fertility during cancer treatment, said Demeestere.

For new targeted therapies, uniform recommendations cannot be issued because of the lack of data and varying treatment durations. Still, the new therapies are safer than chemotherapy.

The need to collect data on fertility and long-term effects in cancer survivors in clinical studies is also reflected in the literature, according to Demeestere. “There are more review articles on this topic than clinical studies.”
 

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Thanks to the continuously improving treatment options for cancer, the number of cancer survivors is increasing, and a large proportion of survivors is confronted with the long-term effects of cancer treatment. Especially for young patients, the question of the impact of therapy on fertility arises.

Dose adjustment or modification of the treatment regimen can achieve a lot. But experts at the congress of the European Society for Medical Oncology (ESMO) 2024 noted that knowledge about newer treatment options like immunotherapies is still insufficient.
 

Therapy Selection

The question of preserving fertility must be considered when deciding on the appropriate treatment, said Matteo Lambertini, MD, PhD, medical oncology consultant at the University of Genoa in Genoa, Italy. A patient’s age, the type of therapy, and the dose are crucial in determining whether or how much fertility is affected. “Preserving fertility is also an aim of cancer therapy,” he said.

Lambertini, who is also a member of the ESMO Guideline Group on fertility preservation in cancer patients, referred to the 2020 ESMO guidelines, which list the gonadotoxicity of a substance depending on the treatment regimen and the patient’s age.

Isabelle Demeestere, MD, PhD, director of the research lab for human reproduction at the Erasmus Hospital of the Free University of Brussels in Brussels, Belgium, pointed out the limitations of general guidelines. “Therapies change over time, and a classification must be updated regularly.”

Knowledge gaps related to well-known therapies and many novel options persist. “For many FDA-approved medications, there are either no fertility data or only preclinical data available,” she added.
 

Chemotherapies and Immunotherapies

Chemotherapies with alkylating or platinum-containing substances are known for their effects on oocytes, follicle maturation, and spermatogenesis, said Demeestere.

Chemotherapy is gonadotoxic and leads to a temporary decrease in sperm quality or temporary azoospermia in men.

These effects, however, can lead to permanent azoospermia and endocrine disorders, depending on the dose, duration, or combination with radiation, said Demeestere.

Cryopreservation of sperm should always be performed before starting treatment. For high-risk patients who are prepubertal, samples of testicular tissue are taken.

In women, chemotherapy affects primordial follicles and follicle maturation through DNA damage. This process results in severe or temporary amenorrhea, a temporary or permanent decrease in egg reserve, and ultimately premature egg insufficiency.

Novel immunotherapies also influence fertility, presumably through interactions of the immune system with the reproductive organs. But insufficient data are available, according to Lambertini, who emphasized that “these data are urgently needed, especially for young patients with cancer.”

In a mouse model, immune checkpoint inhibitors affected ovarian function, and the inflammatory reaction in humans can affect fertility. No long-term data are available for women yet, however, explained Demeestere. The effects of other therapeutics such as PARP, CDK4/6, or tyrosine kinase inhibitors, as well as monoclonal antibodies like trastuzumab, are only seen sporadically.

In the PENELOPE-B phase 3 study, the CDK4/6 inhibitor palbociclib did not affect ovarian function, even though the cyclin-dependent kinases play an important role in mitotic arrest, said Demeestere.
 

Adjusting the Regimen

In a PET-guided approach, Demeestere’s research team investigated the effects of dose reduction or adjustment of the treatment regimen of procarbazine and cyclophosphamide on the fertility of patients younger than 45 years with advanced Hodgkin lymphoma.

By regularly controlling tumor growth with PET, the treatment could be adjusted so that the effect on egg reserve or spermatogenesis was significantly reduced and loss of fertility could be prevented.

During the 5-year follow-up period, the ovarian function of participating women was assessed by the serum concentration of follicle-stimulating hormone (FSH), estradiol, and anti-Müllerian hormone (AMH) to evaluate egg reserve. In men, testicular function was assessed at the beginning of the study. At the end of treatment, sperm analysis and FSH and testosterone levels were checked.

Demeestere and colleagues demonstrated that dose reduction or altering the treatment regimen for patients who responded early to treatment (determined by PET-guided monitoring) reduced the risk for gonadotoxicity from 46% to 14.5%. That is, the risk was reduced by more than half.

FSH and AMH correlated with the patient’s age and the dose of the alkylating agent. In men, sperm parameters recovered after dose or agent adjustment compared with the unchanged treatment regimen.

Newer results from the PHERGain study in women with early human epidermal growth factor receptor 2–positive breast cancer also provided hope, according to Demeestere. Under PET-guided control, chemotherapy could be reduced.
 

More Data Needed

The new treatment options pose a challenge to preserving fertility during cancer treatment, said Demeestere.

For new targeted therapies, uniform recommendations cannot be issued because of the lack of data and varying treatment durations. Still, the new therapies are safer than chemotherapy.

The need to collect data on fertility and long-term effects in cancer survivors in clinical studies is also reflected in the literature, according to Demeestere. “There are more review articles on this topic than clinical studies.”
 

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Thanks to the continuously improving treatment options for cancer, the number of cancer survivors is increasing, and a large proportion of survivors is confronted with the long-term effects of cancer treatment. Especially for young patients, the question of the impact of therapy on fertility arises.

Dose adjustment or modification of the treatment regimen can achieve a lot. But experts at the congress of the European Society for Medical Oncology (ESMO) 2024 noted that knowledge about newer treatment options like immunotherapies is still insufficient.
 

Therapy Selection

The question of preserving fertility must be considered when deciding on the appropriate treatment, said Matteo Lambertini, MD, PhD, medical oncology consultant at the University of Genoa in Genoa, Italy. A patient’s age, the type of therapy, and the dose are crucial in determining whether or how much fertility is affected. “Preserving fertility is also an aim of cancer therapy,” he said.

Lambertini, who is also a member of the ESMO Guideline Group on fertility preservation in cancer patients, referred to the 2020 ESMO guidelines, which list the gonadotoxicity of a substance depending on the treatment regimen and the patient’s age.

Isabelle Demeestere, MD, PhD, director of the research lab for human reproduction at the Erasmus Hospital of the Free University of Brussels in Brussels, Belgium, pointed out the limitations of general guidelines. “Therapies change over time, and a classification must be updated regularly.”

Knowledge gaps related to well-known therapies and many novel options persist. “For many FDA-approved medications, there are either no fertility data or only preclinical data available,” she added.
 

Chemotherapies and Immunotherapies

Chemotherapies with alkylating or platinum-containing substances are known for their effects on oocytes, follicle maturation, and spermatogenesis, said Demeestere.

Chemotherapy is gonadotoxic and leads to a temporary decrease in sperm quality or temporary azoospermia in men.

These effects, however, can lead to permanent azoospermia and endocrine disorders, depending on the dose, duration, or combination with radiation, said Demeestere.

Cryopreservation of sperm should always be performed before starting treatment. For high-risk patients who are prepubertal, samples of testicular tissue are taken.

In women, chemotherapy affects primordial follicles and follicle maturation through DNA damage. This process results in severe or temporary amenorrhea, a temporary or permanent decrease in egg reserve, and ultimately premature egg insufficiency.

Novel immunotherapies also influence fertility, presumably through interactions of the immune system with the reproductive organs. But insufficient data are available, according to Lambertini, who emphasized that “these data are urgently needed, especially for young patients with cancer.”

In a mouse model, immune checkpoint inhibitors affected ovarian function, and the inflammatory reaction in humans can affect fertility. No long-term data are available for women yet, however, explained Demeestere. The effects of other therapeutics such as PARP, CDK4/6, or tyrosine kinase inhibitors, as well as monoclonal antibodies like trastuzumab, are only seen sporadically.

In the PENELOPE-B phase 3 study, the CDK4/6 inhibitor palbociclib did not affect ovarian function, even though the cyclin-dependent kinases play an important role in mitotic arrest, said Demeestere.
 

Adjusting the Regimen

In a PET-guided approach, Demeestere’s research team investigated the effects of dose reduction or adjustment of the treatment regimen of procarbazine and cyclophosphamide on the fertility of patients younger than 45 years with advanced Hodgkin lymphoma.

By regularly controlling tumor growth with PET, the treatment could be adjusted so that the effect on egg reserve or spermatogenesis was significantly reduced and loss of fertility could be prevented.

During the 5-year follow-up period, the ovarian function of participating women was assessed by the serum concentration of follicle-stimulating hormone (FSH), estradiol, and anti-Müllerian hormone (AMH) to evaluate egg reserve. In men, testicular function was assessed at the beginning of the study. At the end of treatment, sperm analysis and FSH and testosterone levels were checked.

Demeestere and colleagues demonstrated that dose reduction or altering the treatment regimen for patients who responded early to treatment (determined by PET-guided monitoring) reduced the risk for gonadotoxicity from 46% to 14.5%. That is, the risk was reduced by more than half.

FSH and AMH correlated with the patient’s age and the dose of the alkylating agent. In men, sperm parameters recovered after dose or agent adjustment compared with the unchanged treatment regimen.

Newer results from the PHERGain study in women with early human epidermal growth factor receptor 2–positive breast cancer also provided hope, according to Demeestere. Under PET-guided control, chemotherapy could be reduced.
 

More Data Needed

The new treatment options pose a challenge to preserving fertility during cancer treatment, said Demeestere.

For new targeted therapies, uniform recommendations cannot be issued because of the lack of data and varying treatment durations. Still, the new therapies are safer than chemotherapy.

The need to collect data on fertility and long-term effects in cancer survivors in clinical studies is also reflected in the literature, according to Demeestere. “There are more review articles on this topic than clinical studies.”
 

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.

The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.

The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
 

Flawed Reviews

A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.

As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”

Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.

“There is indeed a problem with research reliability, but it’s not as widespread or severe as some portray,” said Daniele Fanelli, a metascientist at the London School of Economics and Political Science in England. Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
 

Lack of Awareness

A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.

While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”

Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.

A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.

The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
 

Fanelli’s Perspective

Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.

“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.

The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.

The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
 

Flawed Reviews

A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.

As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”

Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.

“There is indeed a problem with research reliability, but it’s not as widespread or severe as some portray,” said Daniele Fanelli, a metascientist at the London School of Economics and Political Science in England. Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
 

Lack of Awareness

A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.

While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”

Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.

A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.

The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
 

Fanelli’s Perspective

Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.

“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.

The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.

The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
 

Flawed Reviews

A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.

As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”

Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.

“There is indeed a problem with research reliability, but it’s not as widespread or severe as some portray,” said Daniele Fanelli, a metascientist at the London School of Economics and Political Science in England. Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
 

Lack of Awareness

A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.

While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”

Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.

A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.

The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
 

Fanelli’s Perspective

Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.

“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Gestational supplementation of 1000 IU/d cholecalciferol (vitamin D3) from early pregnancy until delivery increases the bone mineral content, bone mineral density (BMD), and bone mineral apparent density in children at age 6-7 years.

METHODOLOGY:

• The double-blinded, placebo-controlled MAVIDOS trial of gestational vitamin D supplementation previously showed increased BMD at age 4 years (but no difference at birth), and it is unclear how the effect may persist or change over time.
• In the original trial, researchers randomized 1134 pregnant women with singleton pregnancy from three UK hospitals from 2008 to 2014, and the 723 children born to mothers recruited in Southampton were invited to continue in offspring follow-up.
• Mothers were randomly assigned to receive either 1000-IU/d vitamin D or placebo from 14-17 weeks’ gestation until delivery; women in the placebo arm could take up to 400-IU/d vitamin D.
• In this post hoc analysis, among 454 children who were followed up at age 6-7 years, 447 had a usable whole body and lumbar spine dual-energy x-ray absorptiometry scan (placebo group: n = 216; 48% boys; 98% White mothers and vitamin D group: n = 231; 56% boys; 96% White mothers).
• Offspring follow-up measures at birth and 4 and 6-7 years were bone area, bone mineral content, BMD, and bone mineral apparent density, derived from a dual-energy x-ray absorptiometry scan of whole body less head (WBLH), as well as fat and lean mass.

TAKEAWAY:

• The effect of gestational vitamin D supplementation on bone outcomes in children was similar at ages 4 and 6-7 years.
• At age 6-7 years, gestational vitamin D supplementation resulted in higher WBLH bone mineral content (0.15 SD; 95% CI, 0.04-0.26) and BMD (0.18 SD; 95% CI, 0.06-0.31) than placebo.
• The WBLH bone mineral apparent density (0.18 SD; 95% CI, 0.04-0.32) was also higher in the vitamin D group.
• The lean mass was greater in the vitamin D group (0.09 SD; 95% CI, 0.00-0.17) than in the placebo group.

IN PRACTICE:

“These findings suggest that pregnancy vitamin D supplementation may be an important population health strategy to improve bone health,” the authors wrote.

SOURCE:

This study was led by Rebecca J. Moon, PhD, MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton General Hospital, England. It was published online in The American Journal of Clinical Nutrition.

LIMITATIONS: 

Only individuals with baseline vitamin D levels of 25-100 nmol/L were eligible, excluding those with severe deficiency who might have benefited the most from supplementation. The participants were mostly White and well-educated, commonly overweight, which may have limited generalizability to other populations. Only 47% of the original cohort participated in the follow-up phase. Differences in maternal age, smoking status, and education between participants who remained in the study and those who did not may have introduced bias and affected generalizability.

DISCLOSURES:

The study was supported by Versus Arthritis UK, Medical Research Council, Bupa Foundation, and National Institute for Health and Care Research, Southampton Biomedical Research Centre, and other sources. Some authors disclosed receiving travel reimbursement, speaker or lecture fees, honoraria, research funding, or personal or consultancy fees from Alliance for Better Bone Health and various pharmaceutical, biotechnology, medical device, healthcare, and food and nutrition companies outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Gestational supplementation of 1000 IU/d cholecalciferol (vitamin D3) from early pregnancy until delivery increases the bone mineral content, bone mineral density (BMD), and bone mineral apparent density in children at age 6-7 years.

METHODOLOGY:

• The double-blinded, placebo-controlled MAVIDOS trial of gestational vitamin D supplementation previously showed increased BMD at age 4 years (but no difference at birth), and it is unclear how the effect may persist or change over time.
• In the original trial, researchers randomized 1134 pregnant women with singleton pregnancy from three UK hospitals from 2008 to 2014, and the 723 children born to mothers recruited in Southampton were invited to continue in offspring follow-up.
• Mothers were randomly assigned to receive either 1000-IU/d vitamin D or placebo from 14-17 weeks’ gestation until delivery; women in the placebo arm could take up to 400-IU/d vitamin D.
• In this post hoc analysis, among 454 children who were followed up at age 6-7 years, 447 had a usable whole body and lumbar spine dual-energy x-ray absorptiometry scan (placebo group: n = 216; 48% boys; 98% White mothers and vitamin D group: n = 231; 56% boys; 96% White mothers).
• Offspring follow-up measures at birth and 4 and 6-7 years were bone area, bone mineral content, BMD, and bone mineral apparent density, derived from a dual-energy x-ray absorptiometry scan of whole body less head (WBLH), as well as fat and lean mass.

TAKEAWAY:

• The effect of gestational vitamin D supplementation on bone outcomes in children was similar at ages 4 and 6-7 years.
• At age 6-7 years, gestational vitamin D supplementation resulted in higher WBLH bone mineral content (0.15 SD; 95% CI, 0.04-0.26) and BMD (0.18 SD; 95% CI, 0.06-0.31) than placebo.
• The WBLH bone mineral apparent density (0.18 SD; 95% CI, 0.04-0.32) was also higher in the vitamin D group.
• The lean mass was greater in the vitamin D group (0.09 SD; 95% CI, 0.00-0.17) than in the placebo group.

IN PRACTICE:

“These findings suggest that pregnancy vitamin D supplementation may be an important population health strategy to improve bone health,” the authors wrote.

SOURCE:

This study was led by Rebecca J. Moon, PhD, MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton General Hospital, England. It was published online in The American Journal of Clinical Nutrition.

LIMITATIONS: 

Only individuals with baseline vitamin D levels of 25-100 nmol/L were eligible, excluding those with severe deficiency who might have benefited the most from supplementation. The participants were mostly White and well-educated, commonly overweight, which may have limited generalizability to other populations. Only 47% of the original cohort participated in the follow-up phase. Differences in maternal age, smoking status, and education between participants who remained in the study and those who did not may have introduced bias and affected generalizability.

DISCLOSURES:

The study was supported by Versus Arthritis UK, Medical Research Council, Bupa Foundation, and National Institute for Health and Care Research, Southampton Biomedical Research Centre, and other sources. Some authors disclosed receiving travel reimbursement, speaker or lecture fees, honoraria, research funding, or personal or consultancy fees from Alliance for Better Bone Health and various pharmaceutical, biotechnology, medical device, healthcare, and food and nutrition companies outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Gestational supplementation of 1000 IU/d cholecalciferol (vitamin D3) from early pregnancy until delivery increases the bone mineral content, bone mineral density (BMD), and bone mineral apparent density in children at age 6-7 years.

METHODOLOGY:

• The double-blinded, placebo-controlled MAVIDOS trial of gestational vitamin D supplementation previously showed increased BMD at age 4 years (but no difference at birth), and it is unclear how the effect may persist or change over time.
• In the original trial, researchers randomized 1134 pregnant women with singleton pregnancy from three UK hospitals from 2008 to 2014, and the 723 children born to mothers recruited in Southampton were invited to continue in offspring follow-up.
• Mothers were randomly assigned to receive either 1000-IU/d vitamin D or placebo from 14-17 weeks’ gestation until delivery; women in the placebo arm could take up to 400-IU/d vitamin D.
• In this post hoc analysis, among 454 children who were followed up at age 6-7 years, 447 had a usable whole body and lumbar spine dual-energy x-ray absorptiometry scan (placebo group: n = 216; 48% boys; 98% White mothers and vitamin D group: n = 231; 56% boys; 96% White mothers).
• Offspring follow-up measures at birth and 4 and 6-7 years were bone area, bone mineral content, BMD, and bone mineral apparent density, derived from a dual-energy x-ray absorptiometry scan of whole body less head (WBLH), as well as fat and lean mass.

TAKEAWAY:

• The effect of gestational vitamin D supplementation on bone outcomes in children was similar at ages 4 and 6-7 years.
• At age 6-7 years, gestational vitamin D supplementation resulted in higher WBLH bone mineral content (0.15 SD; 95% CI, 0.04-0.26) and BMD (0.18 SD; 95% CI, 0.06-0.31) than placebo.
• The WBLH bone mineral apparent density (0.18 SD; 95% CI, 0.04-0.32) was also higher in the vitamin D group.
• The lean mass was greater in the vitamin D group (0.09 SD; 95% CI, 0.00-0.17) than in the placebo group.

IN PRACTICE:

“These findings suggest that pregnancy vitamin D supplementation may be an important population health strategy to improve bone health,” the authors wrote.

SOURCE:

This study was led by Rebecca J. Moon, PhD, MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton General Hospital, England. It was published online in The American Journal of Clinical Nutrition.

LIMITATIONS: 

Only individuals with baseline vitamin D levels of 25-100 nmol/L were eligible, excluding those with severe deficiency who might have benefited the most from supplementation. The participants were mostly White and well-educated, commonly overweight, which may have limited generalizability to other populations. Only 47% of the original cohort participated in the follow-up phase. Differences in maternal age, smoking status, and education between participants who remained in the study and those who did not may have introduced bias and affected generalizability.

DISCLOSURES:

The study was supported by Versus Arthritis UK, Medical Research Council, Bupa Foundation, and National Institute for Health and Care Research, Southampton Biomedical Research Centre, and other sources. Some authors disclosed receiving travel reimbursement, speaker or lecture fees, honoraria, research funding, or personal or consultancy fees from Alliance for Better Bone Health and various pharmaceutical, biotechnology, medical device, healthcare, and food and nutrition companies outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Breast cancer incidence has been on the rise, particularly among White women under age 50, but breast cancer deaths — for some, but not all, populations — have been steadily decreasing, according to a biennial update from the American Cancer Society (ACS).

The ACS update, which underscores the persistence of racial and ethnic disparities in breast cancer incidence and outcomes, noted an overall 1% annual increase in breast cancer incidence from 2012 to 2021. The additional cases were largely composed of localized-stage and hormone receptor (HR)–positive disease, which generally have better prognoses than more advanced and HR–negative disease.

Deaths from breast cancer, however, declined from 1989 to 2022, with an overall drop of 44%. That percentage drop “translates to almost 518,000 fewer women dying from breast cancer in the United States during this time,” Angela N. Giaquinto and ACS colleagues noted in the report, published in CA: A Cancer Journal for Clinicians.

“This progress is the result of advances in treatment and earlier detection through screening,” the authors wrote, while stressing that “these interventions have not been disseminated equally.”

The ACS also published an educational companion — Breast Cancer Facts & Figures 2024-2025 — that provides additional insights about trends in breast cancer and steps needed to bolster prevention, detection, and treatment advances.
 

Incidence and Mortality

Although the overall annual increase in breast cancer incidence from 2012 to 2021 was 1%, the increase was steeper among women under age 50, at 1.4% annually vs 0.7% among those aged 50 or older.

Asian American/Pacific Islander women had the greatest increases in breast cancer incidence among both age groups, with a 2.7% annual increase for those aged under 50 and a 2.5% increase for those aged 50 or older. This group, however, had the second lowest breast cancer rate in 2000 at 57.4 cases per 100,000 persons, but the highest rate in 2021 at 86.3 cases per 100,000, alongside White women (86.4 cases per 100,000). Black women were not far behind at 81.5 cases per 100,000.

Black women were least likely to be diagnosed with localized-stage breast cancer and most likely to be diagnosed with distant-stage or unstaged cancer, with American Indian/Alaska Native women not far behind.

Despite the rising incidence of breast cancer, death rates from the disease have gone down considerably overall from about 33 deaths per 100,000 women in 1989 to 19 deaths per 100,000 in 2022.

However, not all women have experienced these survival gains equally, Ms. Giaquinto and colleagues noted.

Since 1990, the mortality rate has remained unchanged among American Indian/Alaska Native women. Black women, however, have experienced a 38% higher mortality rate than White women, despite having a 5% lower incidence of breast cancer.

In fact, Black women have the lowest survival of any racial and ethnic group for every breast cancer subtype and stage of disease except localized disease.

Additional key findings from the report:

• In 2024, an estimated 310,720 new invasive breast cancers and 56,500 cases of ductal carcinoma in situ will be diagnosed among women in the United States, and an additional 2790 cases will be diagnosed in men.
• On the mortality front, in 2024, approximately 42,250 women are expected to die of breast cancer; 530 breast cancer deaths are anticipated in men.
• As for the lifetime risk for breast cancer, approximately one in eight women in the United States (13.1%) will be diagnosed with invasive breast cancer; 1 in 43 (2.3%) will die from the disease.
• The 5-year relative survival rate for breast cancer is 91%, but that drops to 86% at 10 years and 81% at 15 years.
• The 5-year relative survival rate is over 99% for breast cancer diagnosed at a localized stage but drops to 87% for regional-stage and 32% for distant-stage disease.
• American Indian/Alaska Native women have a 10% lower breast cancer incidence than White women but 6% higher mortality.

Similar to the ACS report, a recent study published in JAMA Network Open reported rising breast cancer incidence among US women aged 20-49 years of different races in different age groups over the past 2 decades.

The increased incidence of breast cancer in younger women “is an area of concern and an area where we really need to spend more effort trying to understand why,” said lead study author and breast surgeon Adetunji T. Toriola, MD, PhD, MPH, of Washington University in St Louis, Missouri.

Although reproductive and lifestyle factors, such as weight gain, diet, and physical activity, may contribute to the growing breast cancer incidence in younger women — and preliminary findings from Dr. Toriola’s own research suggest that reproductive factors may be a particularly strong driver — environmental factors, including exposure to forever chemicals, may also play a role.

Early-life factors, such as exposure to toxins, remain an underexplored area, Dr. Toriola noted, stressing the importance of teasing out the long-term effects of environmental exposures in puberty and during adolescence.

Overall, the trends observed both in this study and the ACS report highlight the need for enhanced prevention efforts that address racial disparities as well as the rising incidence in young women, said Dr. Toriola, also professor of surgery at the Washington University Institute of Public Health, St Louis.

For now, Dr. Toriola urges women to “engage with mammographic screening as soon as qualified” as per guidelines. Women at average risk should go for screening beginning at age 40, and those with a family history or other risk factors should talk to their physician about earlier screening, he said.

Ms. Giaquinto is employed by the ACS, which receives grants from private and corporate foundations, including foundations associated with companies in the health sector, for research outside of the submitted work. Dr. Toriola reported having no disclosures.

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

Breast cancer incidence has been on the rise, particularly among White women under age 50, but breast cancer deaths — for some, but not all, populations — have been steadily decreasing, according to a biennial update from the American Cancer Society (ACS).

The ACS update, which underscores the persistence of racial and ethnic disparities in breast cancer incidence and outcomes, noted an overall 1% annual increase in breast cancer incidence from 2012 to 2021. The additional cases were largely composed of localized-stage and hormone receptor (HR)–positive disease, which generally have better prognoses than more advanced and HR–negative disease.

Deaths from breast cancer, however, declined from 1989 to 2022, with an overall drop of 44%. That percentage drop “translates to almost 518,000 fewer women dying from breast cancer in the United States during this time,” Angela N. Giaquinto and ACS colleagues noted in the report, published in CA: A Cancer Journal for Clinicians.

“This progress is the result of advances in treatment and earlier detection through screening,” the authors wrote, while stressing that “these interventions have not been disseminated equally.”

The ACS also published an educational companion — Breast Cancer Facts & Figures 2024-2025 — that provides additional insights about trends in breast cancer and steps needed to bolster prevention, detection, and treatment advances.
 

Incidence and Mortality

Although the overall annual increase in breast cancer incidence from 2012 to 2021 was 1%, the increase was steeper among women under age 50, at 1.4% annually vs 0.7% among those aged 50 or older.

Asian American/Pacific Islander women had the greatest increases in breast cancer incidence among both age groups, with a 2.7% annual increase for those aged under 50 and a 2.5% increase for those aged 50 or older. This group, however, had the second lowest breast cancer rate in 2000 at 57.4 cases per 100,000 persons, but the highest rate in 2021 at 86.3 cases per 100,000, alongside White women (86.4 cases per 100,000). Black women were not far behind at 81.5 cases per 100,000.

Black women were least likely to be diagnosed with localized-stage breast cancer and most likely to be diagnosed with distant-stage or unstaged cancer, with American Indian/Alaska Native women not far behind.

Despite the rising incidence of breast cancer, death rates from the disease have gone down considerably overall from about 33 deaths per 100,000 women in 1989 to 19 deaths per 100,000 in 2022.

However, not all women have experienced these survival gains equally, Ms. Giaquinto and colleagues noted.

Since 1990, the mortality rate has remained unchanged among American Indian/Alaska Native women. Black women, however, have experienced a 38% higher mortality rate than White women, despite having a 5% lower incidence of breast cancer.

In fact, Black women have the lowest survival of any racial and ethnic group for every breast cancer subtype and stage of disease except localized disease.

Additional key findings from the report:

• In 2024, an estimated 310,720 new invasive breast cancers and 56,500 cases of ductal carcinoma in situ will be diagnosed among women in the United States, and an additional 2790 cases will be diagnosed in men.
• On the mortality front, in 2024, approximately 42,250 women are expected to die of breast cancer; 530 breast cancer deaths are anticipated in men.
• As for the lifetime risk for breast cancer, approximately one in eight women in the United States (13.1%) will be diagnosed with invasive breast cancer; 1 in 43 (2.3%) will die from the disease.
• The 5-year relative survival rate for breast cancer is 91%, but that drops to 86% at 10 years and 81% at 15 years.
• The 5-year relative survival rate is over 99% for breast cancer diagnosed at a localized stage but drops to 87% for regional-stage and 32% for distant-stage disease.
• American Indian/Alaska Native women have a 10% lower breast cancer incidence than White women but 6% higher mortality.

Similar to the ACS report, a recent study published in JAMA Network Open reported rising breast cancer incidence among US women aged 20-49 years of different races in different age groups over the past 2 decades.

The increased incidence of breast cancer in younger women “is an area of concern and an area where we really need to spend more effort trying to understand why,” said lead study author and breast surgeon Adetunji T. Toriola, MD, PhD, MPH, of Washington University in St Louis, Missouri.

Although reproductive and lifestyle factors, such as weight gain, diet, and physical activity, may contribute to the growing breast cancer incidence in younger women — and preliminary findings from Dr. Toriola’s own research suggest that reproductive factors may be a particularly strong driver — environmental factors, including exposure to forever chemicals, may also play a role.

Early-life factors, such as exposure to toxins, remain an underexplored area, Dr. Toriola noted, stressing the importance of teasing out the long-term effects of environmental exposures in puberty and during adolescence.

Overall, the trends observed both in this study and the ACS report highlight the need for enhanced prevention efforts that address racial disparities as well as the rising incidence in young women, said Dr. Toriola, also professor of surgery at the Washington University Institute of Public Health, St Louis.

For now, Dr. Toriola urges women to “engage with mammographic screening as soon as qualified” as per guidelines. Women at average risk should go for screening beginning at age 40, and those with a family history or other risk factors should talk to their physician about earlier screening, he said.

Ms. Giaquinto is employed by the ACS, which receives grants from private and corporate foundations, including foundations associated with companies in the health sector, for research outside of the submitted work. Dr. Toriola reported having no disclosures.

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

Breast cancer incidence has been on the rise, particularly among White women under age 50, but breast cancer deaths — for some, but not all, populations — have been steadily decreasing, according to a biennial update from the American Cancer Society (ACS).

The ACS update, which underscores the persistence of racial and ethnic disparities in breast cancer incidence and outcomes, noted an overall 1% annual increase in breast cancer incidence from 2012 to 2021. The additional cases were largely composed of localized-stage and hormone receptor (HR)–positive disease, which generally have better prognoses than more advanced and HR–negative disease.

Deaths from breast cancer, however, declined from 1989 to 2022, with an overall drop of 44%. That percentage drop “translates to almost 518,000 fewer women dying from breast cancer in the United States during this time,” Angela N. Giaquinto and ACS colleagues noted in the report, published in CA: A Cancer Journal for Clinicians.

“This progress is the result of advances in treatment and earlier detection through screening,” the authors wrote, while stressing that “these interventions have not been disseminated equally.”

The ACS also published an educational companion — Breast Cancer Facts & Figures 2024-2025 — that provides additional insights about trends in breast cancer and steps needed to bolster prevention, detection, and treatment advances.
 

Incidence and Mortality

Although the overall annual increase in breast cancer incidence from 2012 to 2021 was 1%, the increase was steeper among women under age 50, at 1.4% annually vs 0.7% among those aged 50 or older.

Asian American/Pacific Islander women had the greatest increases in breast cancer incidence among both age groups, with a 2.7% annual increase for those aged under 50 and a 2.5% increase for those aged 50 or older. This group, however, had the second lowest breast cancer rate in 2000 at 57.4 cases per 100,000 persons, but the highest rate in 2021 at 86.3 cases per 100,000, alongside White women (86.4 cases per 100,000). Black women were not far behind at 81.5 cases per 100,000.

Black women were least likely to be diagnosed with localized-stage breast cancer and most likely to be diagnosed with distant-stage or unstaged cancer, with American Indian/Alaska Native women not far behind.

Despite the rising incidence of breast cancer, death rates from the disease have gone down considerably overall from about 33 deaths per 100,000 women in 1989 to 19 deaths per 100,000 in 2022.

However, not all women have experienced these survival gains equally, Ms. Giaquinto and colleagues noted.

Since 1990, the mortality rate has remained unchanged among American Indian/Alaska Native women. Black women, however, have experienced a 38% higher mortality rate than White women, despite having a 5% lower incidence of breast cancer.

In fact, Black women have the lowest survival of any racial and ethnic group for every breast cancer subtype and stage of disease except localized disease.

Additional key findings from the report:

• In 2024, an estimated 310,720 new invasive breast cancers and 56,500 cases of ductal carcinoma in situ will be diagnosed among women in the United States, and an additional 2790 cases will be diagnosed in men.
• On the mortality front, in 2024, approximately 42,250 women are expected to die of breast cancer; 530 breast cancer deaths are anticipated in men.
• As for the lifetime risk for breast cancer, approximately one in eight women in the United States (13.1%) will be diagnosed with invasive breast cancer; 1 in 43 (2.3%) will die from the disease.
• The 5-year relative survival rate for breast cancer is 91%, but that drops to 86% at 10 years and 81% at 15 years.
• The 5-year relative survival rate is over 99% for breast cancer diagnosed at a localized stage but drops to 87% for regional-stage and 32% for distant-stage disease.
• American Indian/Alaska Native women have a 10% lower breast cancer incidence than White women but 6% higher mortality.

Similar to the ACS report, a recent study published in JAMA Network Open reported rising breast cancer incidence among US women aged 20-49 years of different races in different age groups over the past 2 decades.

The increased incidence of breast cancer in younger women “is an area of concern and an area where we really need to spend more effort trying to understand why,” said lead study author and breast surgeon Adetunji T. Toriola, MD, PhD, MPH, of Washington University in St Louis, Missouri.

Although reproductive and lifestyle factors, such as weight gain, diet, and physical activity, may contribute to the growing breast cancer incidence in younger women — and preliminary findings from Dr. Toriola’s own research suggest that reproductive factors may be a particularly strong driver — environmental factors, including exposure to forever chemicals, may also play a role.

Early-life factors, such as exposure to toxins, remain an underexplored area, Dr. Toriola noted, stressing the importance of teasing out the long-term effects of environmental exposures in puberty and during adolescence.

Overall, the trends observed both in this study and the ACS report highlight the need for enhanced prevention efforts that address racial disparities as well as the rising incidence in young women, said Dr. Toriola, also professor of surgery at the Washington University Institute of Public Health, St Louis.

For now, Dr. Toriola urges women to “engage with mammographic screening as soon as qualified” as per guidelines. Women at average risk should go for screening beginning at age 40, and those with a family history or other risk factors should talk to their physician about earlier screening, he said.

Ms. Giaquinto is employed by the ACS, which receives grants from private and corporate foundations, including foundations associated with companies in the health sector, for research outside of the submitted work. Dr. Toriola reported having no disclosures.

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

Summary:

In this segment, the speaker discusses how AI is revolutionizing the drug repurposing process. Previously, drug repurposing was limited by manual research on individual diseases and drugs. With AI, scientists can now analyze a vast array of drugs and diseases simultaneously, generating a ranking system based on the likelihood of success. The Center for Cytokine Storm Treatment and Laboratory, along with the platform Every Cure, uses AI to score 3000 drugs against 18,000 diseases. This platform dramatically reduces the time and resources required for drug repurposing, enabling predictions that can be tested in a fraction of the time.
 

Key Takeaways:

AI is accelerating the drug repurposing process, offering faster and more comprehensive analysis of possible drug-disease matches.

The AI-based platform assigns a likelihood score to each potential match, streamlining the process for testing and validation.

The ability to analyze global biomedical knowledge in 24 hours is unprecedented, reducing research costs and increasing the speed of drug discovery.
 

Our Editors Also Recommend: 

AI’s Drug Revolution, Part 1: Faster Trials and Approvals

From AI to Obesity Drugs to Soaring Costs: Medscape Hot Topics in the Medical Profession Report 2024

AI Voice Analysis for Diabetes Screening Shows Promise

To see the full event recording, click here.
 

A version of this article appeared on Medscape.com.

Summary:

In this segment, the speaker discusses how AI is revolutionizing the drug repurposing process. Previously, drug repurposing was limited by manual research on individual diseases and drugs. With AI, scientists can now analyze a vast array of drugs and diseases simultaneously, generating a ranking system based on the likelihood of success. The Center for Cytokine Storm Treatment and Laboratory, along with the platform Every Cure, uses AI to score 3000 drugs against 18,000 diseases. This platform dramatically reduces the time and resources required for drug repurposing, enabling predictions that can be tested in a fraction of the time.
 

Key Takeaways:

AI is accelerating the drug repurposing process, offering faster and more comprehensive analysis of possible drug-disease matches.

The AI-based platform assigns a likelihood score to each potential match, streamlining the process for testing and validation.

The ability to analyze global biomedical knowledge in 24 hours is unprecedented, reducing research costs and increasing the speed of drug discovery.
 

Our Editors Also Recommend: 

AI’s Drug Revolution, Part 1: Faster Trials and Approvals

From AI to Obesity Drugs to Soaring Costs: Medscape Hot Topics in the Medical Profession Report 2024

AI Voice Analysis for Diabetes Screening Shows Promise

To see the full event recording, click here.
 

A version of this article appeared on Medscape.com.

Summary:

In this segment, the speaker discusses how AI is revolutionizing the drug repurposing process. Previously, drug repurposing was limited by manual research on individual diseases and drugs. With AI, scientists can now analyze a vast array of drugs and diseases simultaneously, generating a ranking system based on the likelihood of success. The Center for Cytokine Storm Treatment and Laboratory, along with the platform Every Cure, uses AI to score 3000 drugs against 18,000 diseases. This platform dramatically reduces the time and resources required for drug repurposing, enabling predictions that can be tested in a fraction of the time.
 

Key Takeaways:

AI is accelerating the drug repurposing process, offering faster and more comprehensive analysis of possible drug-disease matches.

The AI-based platform assigns a likelihood score to each potential match, streamlining the process for testing and validation.

The ability to analyze global biomedical knowledge in 24 hours is unprecedented, reducing research costs and increasing the speed of drug discovery.
 

Our Editors Also Recommend: 

AI’s Drug Revolution, Part 1: Faster Trials and Approvals

From AI to Obesity Drugs to Soaring Costs: Medscape Hot Topics in the Medical Profession Report 2024

AI Voice Analysis for Diabetes Screening Shows Promise

To see the full event recording, click here.
 

A version of this article appeared on Medscape.com.