Clinical Endocrinology News

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.

TOPLINE:

Continuous glucose monitoring (CGM) combined with geriatric principles of simplified treatment regimens and personalized glycemic goals reduces hypoglycemia duration in older adults with type 1 diabetes (T1D) without worsening glycemic control.

METHODOLOGY:

• Researchers evaluated the effectiveness of CGM use enhanced by geriatric principles in adults aged ≥ 65 years with T1D and at least two episodes of hypoglycemia (blood glucose level, < 70 mg/dL for ≥ 20 minutes over 2 weeks), who were either CGM-naive or CGM users prior to the study.
• Participants were randomly assigned to an intervention group using CGM with geriatric principles (ie, adjusting goals based on overall health and simplifying regimens based on CGM patterns and clinical characteristics) or a control group receiving usual care by their endocrinologist.
• The primary outcome was the change in duration of hypoglycemia from baseline to 6 months.
• A cost-effectiveness analysis was also performed for the intervention using a healthcare sector perspective, considering the cost of CGM devices and the cost of medical staff time.

TAKEAWAY:

• Researchers included 131 participants (mean age, 71 years), of whom 68 were in the intervention group (35 CGM-naive) and 63 in the control group (23 CGM-naive).
• The intervention group showed a median reduction of 2.6% in the duration of hypoglycemia vs a 0.3% reduction in the control group (median difference, −2.3%; P < .001).
• This reduction was observed in both CGM users (median difference, −1.2%) and CGM-naive participants (median difference, −2.8%) in the intervention group.
• No significant difference in A1c levels was observed between the intervention and control groups, indicating that CGM enhanced with geriatric principles did not worsen glycemic control.
• The intervention was associated with an incremental cost-effectiveness ratio of $71,623 per quality-adjusted life-year and was cost-effective for CGM-naive participants but at a lower level owing to the high cost of the CGM device.

IN PRACTICE:

“Personalization of goals and simplification of complex regimens can be combined with CGM use to improve management of type 1 diabetes in older adults,” the study authors wrote.

SOURCE:

The study was led by Medha N. Munshi, MD, Joslin Diabetes Center, Boston. It was published online in Diabetes Care.

LIMITATIONS:

The study included a relatively small sample size and an ethnically homogeneous and highly educated cohort, which may have limited the generalizability of its findings. Additionally, the study did not measure adherence to individual simplification strategies, which may have hindered the quantification of behavioral changes.

DISCLOSURES:

This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Two authors declared serving as consultants for pharmaceutical companies.

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:

Continuous glucose monitoring (CGM) combined with geriatric principles of simplified treatment regimens and personalized glycemic goals reduces hypoglycemia duration in older adults with type 1 diabetes (T1D) without worsening glycemic control.

METHODOLOGY:

• Researchers evaluated the effectiveness of CGM use enhanced by geriatric principles in adults aged ≥ 65 years with T1D and at least two episodes of hypoglycemia (blood glucose level, < 70 mg/dL for ≥ 20 minutes over 2 weeks), who were either CGM-naive or CGM users prior to the study.
• Participants were randomly assigned to an intervention group using CGM with geriatric principles (ie, adjusting goals based on overall health and simplifying regimens based on CGM patterns and clinical characteristics) or a control group receiving usual care by their endocrinologist.
• The primary outcome was the change in duration of hypoglycemia from baseline to 6 months.
• A cost-effectiveness analysis was also performed for the intervention using a healthcare sector perspective, considering the cost of CGM devices and the cost of medical staff time.

TAKEAWAY:

• Researchers included 131 participants (mean age, 71 years), of whom 68 were in the intervention group (35 CGM-naive) and 63 in the control group (23 CGM-naive).
• The intervention group showed a median reduction of 2.6% in the duration of hypoglycemia vs a 0.3% reduction in the control group (median difference, −2.3%; P < .001).
• This reduction was observed in both CGM users (median difference, −1.2%) and CGM-naive participants (median difference, −2.8%) in the intervention group.
• No significant difference in A1c levels was observed between the intervention and control groups, indicating that CGM enhanced with geriatric principles did not worsen glycemic control.
• The intervention was associated with an incremental cost-effectiveness ratio of $71,623 per quality-adjusted life-year and was cost-effective for CGM-naive participants but at a lower level owing to the high cost of the CGM device.

IN PRACTICE:

“Personalization of goals and simplification of complex regimens can be combined with CGM use to improve management of type 1 diabetes in older adults,” the study authors wrote.

SOURCE:

The study was led by Medha N. Munshi, MD, Joslin Diabetes Center, Boston. It was published online in Diabetes Care.

LIMITATIONS:

The study included a relatively small sample size and an ethnically homogeneous and highly educated cohort, which may have limited the generalizability of its findings. Additionally, the study did not measure adherence to individual simplification strategies, which may have hindered the quantification of behavioral changes.

DISCLOSURES:

This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Two authors declared serving as consultants for pharmaceutical companies.

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:

Continuous glucose monitoring (CGM) combined with geriatric principles of simplified treatment regimens and personalized glycemic goals reduces hypoglycemia duration in older adults with type 1 diabetes (T1D) without worsening glycemic control.

METHODOLOGY:

• Researchers evaluated the effectiveness of CGM use enhanced by geriatric principles in adults aged ≥ 65 years with T1D and at least two episodes of hypoglycemia (blood glucose level, < 70 mg/dL for ≥ 20 minutes over 2 weeks), who were either CGM-naive or CGM users prior to the study.
• Participants were randomly assigned to an intervention group using CGM with geriatric principles (ie, adjusting goals based on overall health and simplifying regimens based on CGM patterns and clinical characteristics) or a control group receiving usual care by their endocrinologist.
• The primary outcome was the change in duration of hypoglycemia from baseline to 6 months.
• A cost-effectiveness analysis was also performed for the intervention using a healthcare sector perspective, considering the cost of CGM devices and the cost of medical staff time.

TAKEAWAY:

• Researchers included 131 participants (mean age, 71 years), of whom 68 were in the intervention group (35 CGM-naive) and 63 in the control group (23 CGM-naive).
• The intervention group showed a median reduction of 2.6% in the duration of hypoglycemia vs a 0.3% reduction in the control group (median difference, −2.3%; P < .001).
• This reduction was observed in both CGM users (median difference, −1.2%) and CGM-naive participants (median difference, −2.8%) in the intervention group.
• No significant difference in A1c levels was observed between the intervention and control groups, indicating that CGM enhanced with geriatric principles did not worsen glycemic control.
• The intervention was associated with an incremental cost-effectiveness ratio of $71,623 per quality-adjusted life-year and was cost-effective for CGM-naive participants but at a lower level owing to the high cost of the CGM device.

IN PRACTICE:

“Personalization of goals and simplification of complex regimens can be combined with CGM use to improve management of type 1 diabetes in older adults,” the study authors wrote.

SOURCE:

The study was led by Medha N. Munshi, MD, Joslin Diabetes Center, Boston. It was published online in Diabetes Care.

LIMITATIONS:

The study included a relatively small sample size and an ethnically homogeneous and highly educated cohort, which may have limited the generalizability of its findings. Additionally, the study did not measure adherence to individual simplification strategies, which may have hindered the quantification of behavioral changes.

DISCLOSURES:

This study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Two authors declared serving as consultants for pharmaceutical companies.

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.

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.

Semaglutide (Ozempic, Novo Nordisk) is associated with a significantly lower risk for overdose in individuals with opioid use disorder (OUD), new research shows.

The findings suggest that the drug may be a promising treatment option for OUD, adding to the growing evidence of the potential psychiatric benefits of glucagon-like peptide 1 (GLP-1) inhibitors.

“Our study provided real-world evidence suggesting that semaglutide could have benefits in preventing opioid overdose and treating opioid use disorder,” co–lead author Rong Xu, PhD, director of the Center for Artificial Intelligence in Drug Discovery at Case Western Reserve University School of Medicine, Cleveland, Ohio, said in an interview.

However, Xu cautioned that this evidence is preliminary and randomized clinical trials are required to confirm these findings.

The study published online in a research letter on September 25 in JAMA Network Open.
 

New Addiction Meds an Urgent Priority

Investigators analyzed electronic medical records from 33,006 patients with type 2 diabetes and OUD who were prescribed one of eight antidiabetic medications between 2017 and 2023. 

Drugs included in the study were semaglutide, insulin, metformin, albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide, dipeptidyl peptidase–4 inhibitors, sodium-glucose cotransporter-2 inhibitors, sulfonylureas, and thiazolidinediones. 

Participants in the semaglutide and each comparison group were matched for certain covariates at baseline, such as socioeconomic status and OUD medications. 

After 1 year, semaglutide was associated with a 42%-68% lower risk for opioid overdose than other antidiabetic medications, including other GLP-1s (range of hazard ratio [HR]: HR, 0.32; 95% CI, 0.12-0.89; to HR, 0.58; 95%CI, 0.38-0.87). 

Xu noted a number of study limitations including the effect of possible confounders and sole reliance on prescription data.

However, the findings are in line with those of prior studies showing that semaglutide may be associated with lower rates of alcohol and nicotine use, she said. 

Earlier this year, Xu, along with National Institute on Drug Abuse Director Nora Volkow, MD, and colleagues, published a retrospective cohort study of nearly 84,000 patients with obesity. That analysis showed that semaglutide was associated with a significantly lower risk of new alcohol use disorder diagnoses. 

In a previous editorial by Xu and Volkow that summarized the research to-date on GLP-1s for nicotine, alcohol, and substance use disorders, they note that “closing the addiction treatment gap and discovering new, more effective addiction medications are urgent priorities. In this regard, investigating the potential of GLP-1 analogue medications to treat substance use disorder deserves fast and rigorous testing.”
 

Caution Warranted

Commenting on the study, Riccardo De Giorgi, MD, PhD, department of psychiatry, University of Oxford in England, said at this point, “we have to be very careful about how we interpret these data.” 

In August, De Giorgi published a study showing that semaglutide was associated with reduced risk for several neurologic and psychiatric outcomes including dementia and nicotine misuse. 

While there is enough observational evidence linking GLP-1 medications with reduced SUD risk, he noted that “now is the time to move on and conduct some randomized clinical trials, specifically testing our hypothesis in people who have psychiatric disorders.”

De Giorgi also called for mechanistic studies of semaglutide and other so that researchers could learn more about how it works to reduce cravings. “Instead of going from bench to bed, we need to go back to the bench,” he said.

As previously reported, De Giorgi recently called on experts in the field to actively explore the potential of GLP-1 inhibitors for mental illness. 

The study was funded by National Institute on Alcohol Abuse and Alcoholism, National Institute on Aging, the National Center for Advancing Translational Sciences, and the Intramural Research Program of the National Institutes of Health. Xu reported no relevant financial relationships. De Giorgi reported receiving funding from the National Institute for Health Research Oxford Health Biomedical Research Centre.

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

Semaglutide (Ozempic, Novo Nordisk) is associated with a significantly lower risk for overdose in individuals with opioid use disorder (OUD), new research shows.

The findings suggest that the drug may be a promising treatment option for OUD, adding to the growing evidence of the potential psychiatric benefits of glucagon-like peptide 1 (GLP-1) inhibitors.

“Our study provided real-world evidence suggesting that semaglutide could have benefits in preventing opioid overdose and treating opioid use disorder,” co–lead author Rong Xu, PhD, director of the Center for Artificial Intelligence in Drug Discovery at Case Western Reserve University School of Medicine, Cleveland, Ohio, said in an interview.

However, Xu cautioned that this evidence is preliminary and randomized clinical trials are required to confirm these findings.

The study published online in a research letter on September 25 in JAMA Network Open.
 

New Addiction Meds an Urgent Priority

Investigators analyzed electronic medical records from 33,006 patients with type 2 diabetes and OUD who were prescribed one of eight antidiabetic medications between 2017 and 2023. 

Drugs included in the study were semaglutide, insulin, metformin, albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide, dipeptidyl peptidase–4 inhibitors, sodium-glucose cotransporter-2 inhibitors, sulfonylureas, and thiazolidinediones. 

Participants in the semaglutide and each comparison group were matched for certain covariates at baseline, such as socioeconomic status and OUD medications. 

After 1 year, semaglutide was associated with a 42%-68% lower risk for opioid overdose than other antidiabetic medications, including other GLP-1s (range of hazard ratio [HR]: HR, 0.32; 95% CI, 0.12-0.89; to HR, 0.58; 95%CI, 0.38-0.87). 

Xu noted a number of study limitations including the effect of possible confounders and sole reliance on prescription data.

However, the findings are in line with those of prior studies showing that semaglutide may be associated with lower rates of alcohol and nicotine use, she said. 

Earlier this year, Xu, along with National Institute on Drug Abuse Director Nora Volkow, MD, and colleagues, published a retrospective cohort study of nearly 84,000 patients with obesity. That analysis showed that semaglutide was associated with a significantly lower risk of new alcohol use disorder diagnoses. 

In a previous editorial by Xu and Volkow that summarized the research to-date on GLP-1s for nicotine, alcohol, and substance use disorders, they note that “closing the addiction treatment gap and discovering new, more effective addiction medications are urgent priorities. In this regard, investigating the potential of GLP-1 analogue medications to treat substance use disorder deserves fast and rigorous testing.”
 

Caution Warranted

Commenting on the study, Riccardo De Giorgi, MD, PhD, department of psychiatry, University of Oxford in England, said at this point, “we have to be very careful about how we interpret these data.” 

In August, De Giorgi published a study showing that semaglutide was associated with reduced risk for several neurologic and psychiatric outcomes including dementia and nicotine misuse. 

While there is enough observational evidence linking GLP-1 medications with reduced SUD risk, he noted that “now is the time to move on and conduct some randomized clinical trials, specifically testing our hypothesis in people who have psychiatric disorders.”

De Giorgi also called for mechanistic studies of semaglutide and other so that researchers could learn more about how it works to reduce cravings. “Instead of going from bench to bed, we need to go back to the bench,” he said.

As previously reported, De Giorgi recently called on experts in the field to actively explore the potential of GLP-1 inhibitors for mental illness. 

The study was funded by National Institute on Alcohol Abuse and Alcoholism, National Institute on Aging, the National Center for Advancing Translational Sciences, and the Intramural Research Program of the National Institutes of Health. Xu reported no relevant financial relationships. De Giorgi reported receiving funding from the National Institute for Health Research Oxford Health Biomedical Research Centre.

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

Semaglutide (Ozempic, Novo Nordisk) is associated with a significantly lower risk for overdose in individuals with opioid use disorder (OUD), new research shows.

The findings suggest that the drug may be a promising treatment option for OUD, adding to the growing evidence of the potential psychiatric benefits of glucagon-like peptide 1 (GLP-1) inhibitors.

“Our study provided real-world evidence suggesting that semaglutide could have benefits in preventing opioid overdose and treating opioid use disorder,” co–lead author Rong Xu, PhD, director of the Center for Artificial Intelligence in Drug Discovery at Case Western Reserve University School of Medicine, Cleveland, Ohio, said in an interview.

However, Xu cautioned that this evidence is preliminary and randomized clinical trials are required to confirm these findings.

The study published online in a research letter on September 25 in JAMA Network Open.
 

New Addiction Meds an Urgent Priority

Investigators analyzed electronic medical records from 33,006 patients with type 2 diabetes and OUD who were prescribed one of eight antidiabetic medications between 2017 and 2023. 

Drugs included in the study were semaglutide, insulin, metformin, albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide, dipeptidyl peptidase–4 inhibitors, sodium-glucose cotransporter-2 inhibitors, sulfonylureas, and thiazolidinediones. 

Participants in the semaglutide and each comparison group were matched for certain covariates at baseline, such as socioeconomic status and OUD medications. 

After 1 year, semaglutide was associated with a 42%-68% lower risk for opioid overdose than other antidiabetic medications, including other GLP-1s (range of hazard ratio [HR]: HR, 0.32; 95% CI, 0.12-0.89; to HR, 0.58; 95%CI, 0.38-0.87). 

Xu noted a number of study limitations including the effect of possible confounders and sole reliance on prescription data.

However, the findings are in line with those of prior studies showing that semaglutide may be associated with lower rates of alcohol and nicotine use, she said. 

Earlier this year, Xu, along with National Institute on Drug Abuse Director Nora Volkow, MD, and colleagues, published a retrospective cohort study of nearly 84,000 patients with obesity. That analysis showed that semaglutide was associated with a significantly lower risk of new alcohol use disorder diagnoses. 

In a previous editorial by Xu and Volkow that summarized the research to-date on GLP-1s for nicotine, alcohol, and substance use disorders, they note that “closing the addiction treatment gap and discovering new, more effective addiction medications are urgent priorities. In this regard, investigating the potential of GLP-1 analogue medications to treat substance use disorder deserves fast and rigorous testing.”
 

Caution Warranted

Commenting on the study, Riccardo De Giorgi, MD, PhD, department of psychiatry, University of Oxford in England, said at this point, “we have to be very careful about how we interpret these data.” 

In August, De Giorgi published a study showing that semaglutide was associated with reduced risk for several neurologic and psychiatric outcomes including dementia and nicotine misuse. 

While there is enough observational evidence linking GLP-1 medications with reduced SUD risk, he noted that “now is the time to move on and conduct some randomized clinical trials, specifically testing our hypothesis in people who have psychiatric disorders.”

De Giorgi also called for mechanistic studies of semaglutide and other so that researchers could learn more about how it works to reduce cravings. “Instead of going from bench to bed, we need to go back to the bench,” he said.

As previously reported, De Giorgi recently called on experts in the field to actively explore the potential of GLP-1 inhibitors for mental illness. 

The study was funded by National Institute on Alcohol Abuse and Alcoholism, National Institute on Aging, the National Center for Advancing Translational Sciences, and the Intramural Research Program of the National Institutes of Health. Xu reported no relevant financial relationships. De Giorgi reported receiving funding from the National Institute for Health Research Oxford Health Biomedical Research Centre.

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

BOSTON — The use of sodium-glucose cotransporter-2 (SGLT2) inhibitors is associated with reduced short- and long-term mortality among patients with pulmonary arterial hypertension (PAH), according to results from a new propensity score–matched analysis.

“There are a lot of new studies that show benefits [of SGLT2 inhibitors] in heart failure, in [chronic kidney disease], and of course, in diabetes. Group one pulmonary hypertension includes not only the inflammatory cascades but also fibrotic and neurovascularization, and all these different parts of the pathophysiology are linked to each other. There are studies that show that SGLT2 inhibitors can have an impact on inflammatory cascades, fibrosis, and vascular remodeling in general. Together, all this data triggered this idea for me, and that’s when I decided to conduct further studies,” said Irakli Lemonjava, MD, who presented the study at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

The researchers drew data on 125,634 adult patients from the TriNetX database who were diagnosed with PAH after January 1, 2013. They used propensity score matching to account for demographic characteristics and 10 organ system disorders to compare patients with exposure to SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin; n = 6238) with those without such exposure (n = 6243).

At 1 year, 8.1% of patients taking SGLT2 inhibitors had died, compared with 15.5% of patients not taking SGLT2 inhibitors (risk reduction [RR], 0.52; P < .0001). The values were 13% and 22.5% (RR, 0.579; P < .0001) at 3 years and 14.6% and 25% at 5 years (RR, 0.583; P < .0001).

The study generated discussion during the Q&A period following the talk. One audience member asked if the group was able to access patients both inside and outside the United States. “Because I wonder if access to GLP2 inhibitors is actually a surrogate marker for access to other medications,” the questioner said.

Although the finding is intriguing, it shouldn’t change clinical practice, according to Lemonjava. “I don’t think we can make any changes based on what I shared today. Our purpose was to trigger the question. I think the numbers are so impressive that it will trigger more studies. I think if in the future it’s demonstrated by clinical trials that [SGLT2 inhibitors are beneficial], it will not be a problem to prescribe for someone with pulmonary arterial hypertension because they do not have many side effects,” he said. Lemonjava is a resident physician at Jefferson Einstein Philadelphia Hospital, Philadelphia.

Session co-moderator said Syed Rehan Quadery, MD, praised the study but emphasized the remaining uncertainty. “It’s an excellent proof of concept study. More trials need to [be done] on it, and we don’t understand the mechanism of action in which it improves survival in patients with pulmonary artery hypertension. The majority of the patients with pulmonary hypertension are much older and they have comorbidities, including cardiovascular risk factors, and maybe that is one of the ways in which this drug helps. Plus, there are multiple mechanisms in which it may be working, including anti-inflammatory as well as antiproliferative mechanisms through inhibiting the Notch-3 signaling pathway,” said Quadery, who is a consultant respiratory physician at National Pulmonary Hypertension Unit, Dublin, Ireland.

Quadery and his co-moderator Zeenat Safdar, MD, both noted that SGLT2 inhibitors have already been demonstrated to improve outcomes in heart failure. “[SGLT2 inhibition] improves survival, it decreases hospitalization, it improves morbidity and mortality. There are a lot of things that can be shown in different [animal or in vitro] models. In humans, we actually don’t know exactly how it works, but we know that it does. If it works in left heart failure, it also [could] work in right heart failure,” said Safdar, who is the director of the Houston Methodist Lung Center, Houston Methodist Hospital, Houston.

The study was independently supported. Lemonjava, Quadery, and Safdar reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

BOSTON — The use of sodium-glucose cotransporter-2 (SGLT2) inhibitors is associated with reduced short- and long-term mortality among patients with pulmonary arterial hypertension (PAH), according to results from a new propensity score–matched analysis.

“There are a lot of new studies that show benefits [of SGLT2 inhibitors] in heart failure, in [chronic kidney disease], and of course, in diabetes. Group one pulmonary hypertension includes not only the inflammatory cascades but also fibrotic and neurovascularization, and all these different parts of the pathophysiology are linked to each other. There are studies that show that SGLT2 inhibitors can have an impact on inflammatory cascades, fibrosis, and vascular remodeling in general. Together, all this data triggered this idea for me, and that’s when I decided to conduct further studies,” said Irakli Lemonjava, MD, who presented the study at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

The researchers drew data on 125,634 adult patients from the TriNetX database who were diagnosed with PAH after January 1, 2013. They used propensity score matching to account for demographic characteristics and 10 organ system disorders to compare patients with exposure to SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin; n = 6238) with those without such exposure (n = 6243).

At 1 year, 8.1% of patients taking SGLT2 inhibitors had died, compared with 15.5% of patients not taking SGLT2 inhibitors (risk reduction [RR], 0.52; P < .0001). The values were 13% and 22.5% (RR, 0.579; P < .0001) at 3 years and 14.6% and 25% at 5 years (RR, 0.583; P < .0001).

The study generated discussion during the Q&A period following the talk. One audience member asked if the group was able to access patients both inside and outside the United States. “Because I wonder if access to GLP2 inhibitors is actually a surrogate marker for access to other medications,” the questioner said.

Although the finding is intriguing, it shouldn’t change clinical practice, according to Lemonjava. “I don’t think we can make any changes based on what I shared today. Our purpose was to trigger the question. I think the numbers are so impressive that it will trigger more studies. I think if in the future it’s demonstrated by clinical trials that [SGLT2 inhibitors are beneficial], it will not be a problem to prescribe for someone with pulmonary arterial hypertension because they do not have many side effects,” he said. Lemonjava is a resident physician at Jefferson Einstein Philadelphia Hospital, Philadelphia.

Session co-moderator said Syed Rehan Quadery, MD, praised the study but emphasized the remaining uncertainty. “It’s an excellent proof of concept study. More trials need to [be done] on it, and we don’t understand the mechanism of action in which it improves survival in patients with pulmonary artery hypertension. The majority of the patients with pulmonary hypertension are much older and they have comorbidities, including cardiovascular risk factors, and maybe that is one of the ways in which this drug helps. Plus, there are multiple mechanisms in which it may be working, including anti-inflammatory as well as antiproliferative mechanisms through inhibiting the Notch-3 signaling pathway,” said Quadery, who is a consultant respiratory physician at National Pulmonary Hypertension Unit, Dublin, Ireland.

Quadery and his co-moderator Zeenat Safdar, MD, both noted that SGLT2 inhibitors have already been demonstrated to improve outcomes in heart failure. “[SGLT2 inhibition] improves survival, it decreases hospitalization, it improves morbidity and mortality. There are a lot of things that can be shown in different [animal or in vitro] models. In humans, we actually don’t know exactly how it works, but we know that it does. If it works in left heart failure, it also [could] work in right heart failure,” said Safdar, who is the director of the Houston Methodist Lung Center, Houston Methodist Hospital, Houston.

The study was independently supported. Lemonjava, Quadery, and Safdar reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

BOSTON — The use of sodium-glucose cotransporter-2 (SGLT2) inhibitors is associated with reduced short- and long-term mortality among patients with pulmonary arterial hypertension (PAH), according to results from a new propensity score–matched analysis.

“There are a lot of new studies that show benefits [of SGLT2 inhibitors] in heart failure, in [chronic kidney disease], and of course, in diabetes. Group one pulmonary hypertension includes not only the inflammatory cascades but also fibrotic and neurovascularization, and all these different parts of the pathophysiology are linked to each other. There are studies that show that SGLT2 inhibitors can have an impact on inflammatory cascades, fibrosis, and vascular remodeling in general. Together, all this data triggered this idea for me, and that’s when I decided to conduct further studies,” said Irakli Lemonjava, MD, who presented the study at the American College of Chest Physicians (CHEST) 2024 Annual Meeting.

The researchers drew data on 125,634 adult patients from the TriNetX database who were diagnosed with PAH after January 1, 2013. They used propensity score matching to account for demographic characteristics and 10 organ system disorders to compare patients with exposure to SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin; n = 6238) with those without such exposure (n = 6243).

At 1 year, 8.1% of patients taking SGLT2 inhibitors had died, compared with 15.5% of patients not taking SGLT2 inhibitors (risk reduction [RR], 0.52; P < .0001). The values were 13% and 22.5% (RR, 0.579; P < .0001) at 3 years and 14.6% and 25% at 5 years (RR, 0.583; P < .0001).

The study generated discussion during the Q&A period following the talk. One audience member asked if the group was able to access patients both inside and outside the United States. “Because I wonder if access to GLP2 inhibitors is actually a surrogate marker for access to other medications,” the questioner said.

Although the finding is intriguing, it shouldn’t change clinical practice, according to Lemonjava. “I don’t think we can make any changes based on what I shared today. Our purpose was to trigger the question. I think the numbers are so impressive that it will trigger more studies. I think if in the future it’s demonstrated by clinical trials that [SGLT2 inhibitors are beneficial], it will not be a problem to prescribe for someone with pulmonary arterial hypertension because they do not have many side effects,” he said. Lemonjava is a resident physician at Jefferson Einstein Philadelphia Hospital, Philadelphia.

Session co-moderator said Syed Rehan Quadery, MD, praised the study but emphasized the remaining uncertainty. “It’s an excellent proof of concept study. More trials need to [be done] on it, and we don’t understand the mechanism of action in which it improves survival in patients with pulmonary artery hypertension. The majority of the patients with pulmonary hypertension are much older and they have comorbidities, including cardiovascular risk factors, and maybe that is one of the ways in which this drug helps. Plus, there are multiple mechanisms in which it may be working, including anti-inflammatory as well as antiproliferative mechanisms through inhibiting the Notch-3 signaling pathway,” said Quadery, who is a consultant respiratory physician at National Pulmonary Hypertension Unit, Dublin, Ireland.

Quadery and his co-moderator Zeenat Safdar, MD, both noted that SGLT2 inhibitors have already been demonstrated to improve outcomes in heart failure. “[SGLT2 inhibition] improves survival, it decreases hospitalization, it improves morbidity and mortality. There are a lot of things that can be shown in different [animal or in vitro] models. In humans, we actually don’t know exactly how it works, but we know that it does. If it works in left heart failure, it also [could] work in right heart failure,” said Safdar, who is the director of the Houston Methodist Lung Center, Houston Methodist Hospital, Houston.

The study was independently supported. Lemonjava, Quadery, and Safdar reported no relevant financial relationships.
 

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.

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:

Metformin use in adults with type 2 diabetes (T2D) is associated with a slightly lower incidence of long COVID and death within 180 days after SARS-CoV-2 infection.

METHODOLOGY:

• Previous studies have shown that metformin use before and during SARS-CoV-2 infection reduces severe COVID-19 and postacute sequelae of SARS-CoV-2 (PASC), also referred to as long COVID, in adults.
• A retrospective cohort analysis was conducted to evaluate the association between metformin use before and during SARS-CoV-2 infection and the subsequent incidence of PASC.
• Researchers used data from the National COVID Cohort Collaborative (N3C) and National Patient-Centered Clinical Research Network (PCORnet) electronic health record (EHR) databases to identify adults (age, ≥ 21 years) with T2D prescribed a diabetes medication within the past 12 months.
• Participants were categorized into those using metformin (metformin group) and those using other noninsulin diabetes medications such as sulfonylureas, dipeptidyl peptidase-4 inhibitors, or thiazolidinediones (the comparator group); those who used glucagon-like peptide 1 receptor agonists or sodium-glucose cotransporter-2 inhibitors were excluded.
• The primary outcome was the incidence of PASC or death within 180 days after SARS-CoV-2 infection, defined using International Classification of Diseases U09.9 diagnosis code and/or computable phenotype defined by a predicted probability of > 75% for PASC using a machine learning model trained on patients diagnosed using U09.9 (PASC computable phenotype).

TAKEAWAY:

• Researchers identified 51,385 and 37,947 participants from the N3C and PCORnet datasets, respectively.
• Metformin use was associated with a 21% lower risk for death or PASC using the U09.9 diagnosis code (P < .001) and a 15% lower risk using the PASC computable phenotype (P < .001) in the N3C dataset than non-metformin use.
• In the PCORnet dataset, the risk for death or PASC was 13% lower using the U09.9 diagnosis code (P = .08) with metformin use vs non-metformin use, whereas the risk did not differ significantly between the groups when using the PASC computable phenotype (P = .58).
• The incidence of PASC using the U09.9 diagnosis code for the metformin and comparator groups was similar between the two datasets (1.6% and 2.0% in N3C and 2.2 and 2.6% in PCORnet, respectively).
• However, when using the computable phenotype, the incidence rates of PASC for the metformin and comparator groups were 4.8% and 5.2% in N3C and 25.2% and 24.2% in PCORnet, respectively.

IN PRACTICE:

“The incidence of PASC was lower when defined by [International Classification of Diseases] code, compared with a computable phenotype in both databases,” the authors wrote. “This may reflect the challenges of clinical care for adults needing chronic medication management and the likelihood of those adults receiving a formal PASC diagnosis.” 

SOURCE:

The study was led by Steven G. Johnson, PhD, Institute for Health Informatics, University of Minnesota, Minneapolis. It was published online in Diabetes Care.

LIMITATIONS:

The use of EHR data had several limitations, including the inability to examine a dose-dependent relationship and the lack of information on whether medications were taken before, during, or after the acute infection. The outcome definition involved the need for a medical encounter and, thus, may not capture data on all patients experiencing symptoms of PASC. The analysis focused on the prevalent use of chronic medications, limiting the assessment of initiating metformin in those diagnosed with COVID-19.

DISCLOSURES:

The study was supported by the National Institutes of Health Agreement as part of the RECOVER research program. One author reported receiving salary support from the Center for Pharmacoepidemiology and owning stock options in various pharmaceutical and biopharmaceutical companies. Another author reported receiving grant support and consulting contracts, being involved in expert witness engagement, and owning stock options in various pharmaceutical, biopharmaceutical, diabetes management, and medical device companies.

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:

Metformin use in adults with type 2 diabetes (T2D) is associated with a slightly lower incidence of long COVID and death within 180 days after SARS-CoV-2 infection.

METHODOLOGY:

• Previous studies have shown that metformin use before and during SARS-CoV-2 infection reduces severe COVID-19 and postacute sequelae of SARS-CoV-2 (PASC), also referred to as long COVID, in adults.
• A retrospective cohort analysis was conducted to evaluate the association between metformin use before and during SARS-CoV-2 infection and the subsequent incidence of PASC.
• Researchers used data from the National COVID Cohort Collaborative (N3C) and National Patient-Centered Clinical Research Network (PCORnet) electronic health record (EHR) databases to identify adults (age, ≥ 21 years) with T2D prescribed a diabetes medication within the past 12 months.
• Participants were categorized into those using metformin (metformin group) and those using other noninsulin diabetes medications such as sulfonylureas, dipeptidyl peptidase-4 inhibitors, or thiazolidinediones (the comparator group); those who used glucagon-like peptide 1 receptor agonists or sodium-glucose cotransporter-2 inhibitors were excluded.
• The primary outcome was the incidence of PASC or death within 180 days after SARS-CoV-2 infection, defined using International Classification of Diseases U09.9 diagnosis code and/or computable phenotype defined by a predicted probability of > 75% for PASC using a machine learning model trained on patients diagnosed using U09.9 (PASC computable phenotype).

TAKEAWAY:

• Researchers identified 51,385 and 37,947 participants from the N3C and PCORnet datasets, respectively.
• Metformin use was associated with a 21% lower risk for death or PASC using the U09.9 diagnosis code (P < .001) and a 15% lower risk using the PASC computable phenotype (P < .001) in the N3C dataset than non-metformin use.
• In the PCORnet dataset, the risk for death or PASC was 13% lower using the U09.9 diagnosis code (P = .08) with metformin use vs non-metformin use, whereas the risk did not differ significantly between the groups when using the PASC computable phenotype (P = .58).
• The incidence of PASC using the U09.9 diagnosis code for the metformin and comparator groups was similar between the two datasets (1.6% and 2.0% in N3C and 2.2 and 2.6% in PCORnet, respectively).
• However, when using the computable phenotype, the incidence rates of PASC for the metformin and comparator groups were 4.8% and 5.2% in N3C and 25.2% and 24.2% in PCORnet, respectively.

IN PRACTICE:

“The incidence of PASC was lower when defined by [International Classification of Diseases] code, compared with a computable phenotype in both databases,” the authors wrote. “This may reflect the challenges of clinical care for adults needing chronic medication management and the likelihood of those adults receiving a formal PASC diagnosis.” 

SOURCE:

The study was led by Steven G. Johnson, PhD, Institute for Health Informatics, University of Minnesota, Minneapolis. It was published online in Diabetes Care.

LIMITATIONS:

The use of EHR data had several limitations, including the inability to examine a dose-dependent relationship and the lack of information on whether medications were taken before, during, or after the acute infection. The outcome definition involved the need for a medical encounter and, thus, may not capture data on all patients experiencing symptoms of PASC. The analysis focused on the prevalent use of chronic medications, limiting the assessment of initiating metformin in those diagnosed with COVID-19.

DISCLOSURES:

The study was supported by the National Institutes of Health Agreement as part of the RECOVER research program. One author reported receiving salary support from the Center for Pharmacoepidemiology and owning stock options in various pharmaceutical and biopharmaceutical companies. Another author reported receiving grant support and consulting contracts, being involved in expert witness engagement, and owning stock options in various pharmaceutical, biopharmaceutical, diabetes management, and medical device companies.

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:

Metformin use in adults with type 2 diabetes (T2D) is associated with a slightly lower incidence of long COVID and death within 180 days after SARS-CoV-2 infection.

METHODOLOGY:

• Previous studies have shown that metformin use before and during SARS-CoV-2 infection reduces severe COVID-19 and postacute sequelae of SARS-CoV-2 (PASC), also referred to as long COVID, in adults.
• A retrospective cohort analysis was conducted to evaluate the association between metformin use before and during SARS-CoV-2 infection and the subsequent incidence of PASC.
• Researchers used data from the National COVID Cohort Collaborative (N3C) and National Patient-Centered Clinical Research Network (PCORnet) electronic health record (EHR) databases to identify adults (age, ≥ 21 years) with T2D prescribed a diabetes medication within the past 12 months.
• Participants were categorized into those using metformin (metformin group) and those using other noninsulin diabetes medications such as sulfonylureas, dipeptidyl peptidase-4 inhibitors, or thiazolidinediones (the comparator group); those who used glucagon-like peptide 1 receptor agonists or sodium-glucose cotransporter-2 inhibitors were excluded.
• The primary outcome was the incidence of PASC or death within 180 days after SARS-CoV-2 infection, defined using International Classification of Diseases U09.9 diagnosis code and/or computable phenotype defined by a predicted probability of > 75% for PASC using a machine learning model trained on patients diagnosed using U09.9 (PASC computable phenotype).

TAKEAWAY:

• Researchers identified 51,385 and 37,947 participants from the N3C and PCORnet datasets, respectively.
• Metformin use was associated with a 21% lower risk for death or PASC using the U09.9 diagnosis code (P < .001) and a 15% lower risk using the PASC computable phenotype (P < .001) in the N3C dataset than non-metformin use.
• In the PCORnet dataset, the risk for death or PASC was 13% lower using the U09.9 diagnosis code (P = .08) with metformin use vs non-metformin use, whereas the risk did not differ significantly between the groups when using the PASC computable phenotype (P = .58).
• The incidence of PASC using the U09.9 diagnosis code for the metformin and comparator groups was similar between the two datasets (1.6% and 2.0% in N3C and 2.2 and 2.6% in PCORnet, respectively).
• However, when using the computable phenotype, the incidence rates of PASC for the metformin and comparator groups were 4.8% and 5.2% in N3C and 25.2% and 24.2% in PCORnet, respectively.

IN PRACTICE:

“The incidence of PASC was lower when defined by [International Classification of Diseases] code, compared with a computable phenotype in both databases,” the authors wrote. “This may reflect the challenges of clinical care for adults needing chronic medication management and the likelihood of those adults receiving a formal PASC diagnosis.” 

SOURCE:

The study was led by Steven G. Johnson, PhD, Institute for Health Informatics, University of Minnesota, Minneapolis. It was published online in Diabetes Care.

LIMITATIONS:

The use of EHR data had several limitations, including the inability to examine a dose-dependent relationship and the lack of information on whether medications were taken before, during, or after the acute infection. The outcome definition involved the need for a medical encounter and, thus, may not capture data on all patients experiencing symptoms of PASC. The analysis focused on the prevalent use of chronic medications, limiting the assessment of initiating metformin in those diagnosed with COVID-19.

DISCLOSURES:

The study was supported by the National Institutes of Health Agreement as part of the RECOVER research program. One author reported receiving salary support from the Center for Pharmacoepidemiology and owning stock options in various pharmaceutical and biopharmaceutical companies. Another author reported receiving grant support and consulting contracts, being involved in expert witness engagement, and owning stock options in various pharmaceutical, biopharmaceutical, diabetes management, and medical device companies.

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.

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.