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Breast cancer-specific mortality risk in men with hormone receptor–positive breast cancer persists for at least 20 years, but patterns of breast cancer–specific mortality (BCSM) are distinct from those in women, a new study finds.

Previous studies in women with hormone receptor–positive (HR+) breast cancer have shown a risk of distant recurrence and death for at least 20 years after diagnosis, but data for men are limited, wrote Julieta Leone, MD, of the Dana Farber Cancer Institute, Boston, and colleagues.
 

What is Known About Hormone Receptor–Positive Breast Cancer Mortality in Men vs. Women?

Invasive breast cancer in men is rare and consequently understudied, the researchers wrote. Previous studies of BCSM in men with more than 5 years’ follow-up consist mainly of case series at single institutions, the researchers wrote in JAMA Oncology (2024 Feb 29. doi: 10.1001/jamaoncol.2023.7194).

“We believed it would be important to study this issue to help inform the management of men with breast cancer,” corresponding author, José P. Leone, MD, said in an interview.

In 2021, Dr. J.P. Leone and colleagues published a study in Breast Cancer Research and Treatment that examined the 20-year risk of BCSM in women that included more than 36,000 individuals who had survived for 5 years, with a median of 14 years’ follow-up.

In that study of women, the BCSM risk at 20 years was significantly higher for those with HR-negative tumors, but the risk was still elevated for both types. Patients with stage IIIC HR-positive disease had four times the risk of BCSM over 20 years and those with stage IIIC HR-negative disease had seven times the risk of BCSM over 20 years compared with the risk of death not related to breast cancer, the researchers wrote.

Another study of nearly 2,400 men with breast cancer (mainly HR+) by Dr. J.P. Leone and colleagues showed that cancer stage, tumor subtype, and race were associated with overall survival and breast cancer-specific survival.
 

What Does the New Study Add?

The current study included 2,836 men diagnosed with stage I to stage III HR+ breast cancer between 1990 and 2008, using data from the Surveillance, Epidemiology, and End Results (SEER) database.

“We found that in men with breast cancer, the risk of breast cancer mortality persists for at least 20 years and that [the risk] depends on traditional clinicopathologic factors, such as age, tumor size, nodal status and tumor grade,” Dr. J.P. Leone said in an interview.

“The prolonged risk [of breast-cancer specific mortality] over 20 years that we observed in our study is similar to that previously reported in women; however, the kinetics of the risk over the 20-year period appears different in men,” he emphasized.

The men in the study, especially those with a higher stage of disease, appeared to have a bimodal distribution of the BRCA mortality risk, he said.

Two peaks were identified, he explained; an early peak in mortality risk at approximately 4 years from diagnosis and another at approximately 11 years after diagnosis.

Although women with breast cancer had a prolonged risk of breast cancer mortality, “the kinetics of the risk does not include 2 peaks, even in women with higher stage of disease.” In women with higher stage breast cancer, the peak mortality risk occurs approximately 5 years after diagnosis, he said.

The reasons for the later peak in men remain unclear, the researchers wrote in the study, but possible explanations include nonadherence to endocrine therapy, differences in tumor biologic factors, and differences in the tumor microenvironment between men and women, they noted, in the discussion section.
 

What Drives the Risk?

Key factors for breast cancer-specific mortality were age, tumor stage, and tumor grade.

The cumulative 20-year risk of BCSM in the current study was 12.4%, 26.2%, and 46.0% for stage I, II, and III, respectively. The adjusted BCSM risk was increased in patients younger than 50 years, those with grade II or III/IV tumors, and those with stage II or III disease.
 

What Are the Limitations?

The current study by Leone and colleagues was limited by the relatively small subgroup sample of men with stage III and N3 disease, lack of data on the use of systemic therapies, and lack of data on human epidermal growth factor receptor 2 gene (ERBB2), the researchers wrote. However, the long-term follow-up strengthened the results, and the study is the first known to assess 20-year BCSM risk in men with nonmetastatic HR+ breast cancer.

What Do Oncologists Need to Know About the Study?

The study findings indicate that the risk of breast cancer mortality persists for 20 years in men with hormone receptor–positive breast cancer, Dr. J.P. Leone said in an interview. As in women, the risk depends on traditional clinicopathologic factors, he noted.

“However, the kinetics of that risk appears to be different between men and women. In order to reduce the breast cancer mortality risk in men with hormone receptor–positive breast cancer, it will be important for men to consider the benefits of the treatment options that may be indicated for their specific situation,” he said.

“I think early detection is also very important,” he emphasized. To that end, increased awareness of the possibility for breast cancer in men, as well as prompt intervention when breast cancer is suspected, will help to improve early detection when the risk of breast cancer mortality is lower, he added.
 

What Are the Next Steps for Research?

“I think our study underscores the need for additional research to improve our adjuvant therapy options in both men and women with hormone receptor-positive breast cancer, to reduce the risk of long-term mortality,” he said.

The study received no outside funding. Lead author Julieta Leone had no financial conflicts to disclose. Dr. José P. Leone disclosed receiving institutional grants from Kazia Therapeutics and Seagen unrelated to the current study.

Breast cancer-specific mortality risk in men with hormone receptor–positive breast cancer persists for at least 20 years, but patterns of breast cancer–specific mortality (BCSM) are distinct from those in women, a new study finds.

Previous studies in women with hormone receptor–positive (HR+) breast cancer have shown a risk of distant recurrence and death for at least 20 years after diagnosis, but data for men are limited, wrote Julieta Leone, MD, of the Dana Farber Cancer Institute, Boston, and colleagues.
 

What is Known About Hormone Receptor–Positive Breast Cancer Mortality in Men vs. Women?

Invasive breast cancer in men is rare and consequently understudied, the researchers wrote. Previous studies of BCSM in men with more than 5 years’ follow-up consist mainly of case series at single institutions, the researchers wrote in JAMA Oncology (2024 Feb 29. doi: 10.1001/jamaoncol.2023.7194).

“We believed it would be important to study this issue to help inform the management of men with breast cancer,” corresponding author, José P. Leone, MD, said in an interview.

In 2021, Dr. J.P. Leone and colleagues published a study in Breast Cancer Research and Treatment that examined the 20-year risk of BCSM in women that included more than 36,000 individuals who had survived for 5 years, with a median of 14 years’ follow-up.

In that study of women, the BCSM risk at 20 years was significantly higher for those with HR-negative tumors, but the risk was still elevated for both types. Patients with stage IIIC HR-positive disease had four times the risk of BCSM over 20 years and those with stage IIIC HR-negative disease had seven times the risk of BCSM over 20 years compared with the risk of death not related to breast cancer, the researchers wrote.

Another study of nearly 2,400 men with breast cancer (mainly HR+) by Dr. J.P. Leone and colleagues showed that cancer stage, tumor subtype, and race were associated with overall survival and breast cancer-specific survival.
 

What Does the New Study Add?

The current study included 2,836 men diagnosed with stage I to stage III HR+ breast cancer between 1990 and 2008, using data from the Surveillance, Epidemiology, and End Results (SEER) database.

“We found that in men with breast cancer, the risk of breast cancer mortality persists for at least 20 years and that [the risk] depends on traditional clinicopathologic factors, such as age, tumor size, nodal status and tumor grade,” Dr. J.P. Leone said in an interview.

“The prolonged risk [of breast-cancer specific mortality] over 20 years that we observed in our study is similar to that previously reported in women; however, the kinetics of the risk over the 20-year period appears different in men,” he emphasized.

The men in the study, especially those with a higher stage of disease, appeared to have a bimodal distribution of the BRCA mortality risk, he said.

Two peaks were identified, he explained; an early peak in mortality risk at approximately 4 years from diagnosis and another at approximately 11 years after diagnosis.

Although women with breast cancer had a prolonged risk of breast cancer mortality, “the kinetics of the risk does not include 2 peaks, even in women with higher stage of disease.” In women with higher stage breast cancer, the peak mortality risk occurs approximately 5 years after diagnosis, he said.

The reasons for the later peak in men remain unclear, the researchers wrote in the study, but possible explanations include nonadherence to endocrine therapy, differences in tumor biologic factors, and differences in the tumor microenvironment between men and women, they noted, in the discussion section.
 

What Drives the Risk?

Key factors for breast cancer-specific mortality were age, tumor stage, and tumor grade.

The cumulative 20-year risk of BCSM in the current study was 12.4%, 26.2%, and 46.0% for stage I, II, and III, respectively. The adjusted BCSM risk was increased in patients younger than 50 years, those with grade II or III/IV tumors, and those with stage II or III disease.
 

What Are the Limitations?

The current study by Leone and colleagues was limited by the relatively small subgroup sample of men with stage III and N3 disease, lack of data on the use of systemic therapies, and lack of data on human epidermal growth factor receptor 2 gene (ERBB2), the researchers wrote. However, the long-term follow-up strengthened the results, and the study is the first known to assess 20-year BCSM risk in men with nonmetastatic HR+ breast cancer.

What Do Oncologists Need to Know About the Study?

The study findings indicate that the risk of breast cancer mortality persists for 20 years in men with hormone receptor–positive breast cancer, Dr. J.P. Leone said in an interview. As in women, the risk depends on traditional clinicopathologic factors, he noted.

“However, the kinetics of that risk appears to be different between men and women. In order to reduce the breast cancer mortality risk in men with hormone receptor–positive breast cancer, it will be important for men to consider the benefits of the treatment options that may be indicated for their specific situation,” he said.

“I think early detection is also very important,” he emphasized. To that end, increased awareness of the possibility for breast cancer in men, as well as prompt intervention when breast cancer is suspected, will help to improve early detection when the risk of breast cancer mortality is lower, he added.
 

What Are the Next Steps for Research?

“I think our study underscores the need for additional research to improve our adjuvant therapy options in both men and women with hormone receptor-positive breast cancer, to reduce the risk of long-term mortality,” he said.

The study received no outside funding. Lead author Julieta Leone had no financial conflicts to disclose. Dr. José P. Leone disclosed receiving institutional grants from Kazia Therapeutics and Seagen unrelated to the current study.

Breast cancer-specific mortality risk in men with hormone receptor–positive breast cancer persists for at least 20 years, but patterns of breast cancer–specific mortality (BCSM) are distinct from those in women, a new study finds.

Previous studies in women with hormone receptor–positive (HR+) breast cancer have shown a risk of distant recurrence and death for at least 20 years after diagnosis, but data for men are limited, wrote Julieta Leone, MD, of the Dana Farber Cancer Institute, Boston, and colleagues.
 

What is Known About Hormone Receptor–Positive Breast Cancer Mortality in Men vs. Women?

Invasive breast cancer in men is rare and consequently understudied, the researchers wrote. Previous studies of BCSM in men with more than 5 years’ follow-up consist mainly of case series at single institutions, the researchers wrote in JAMA Oncology (2024 Feb 29. doi: 10.1001/jamaoncol.2023.7194).

“We believed it would be important to study this issue to help inform the management of men with breast cancer,” corresponding author, José P. Leone, MD, said in an interview.

In 2021, Dr. J.P. Leone and colleagues published a study in Breast Cancer Research and Treatment that examined the 20-year risk of BCSM in women that included more than 36,000 individuals who had survived for 5 years, with a median of 14 years’ follow-up.

In that study of women, the BCSM risk at 20 years was significantly higher for those with HR-negative tumors, but the risk was still elevated for both types. Patients with stage IIIC HR-positive disease had four times the risk of BCSM over 20 years and those with stage IIIC HR-negative disease had seven times the risk of BCSM over 20 years compared with the risk of death not related to breast cancer, the researchers wrote.

Another study of nearly 2,400 men with breast cancer (mainly HR+) by Dr. J.P. Leone and colleagues showed that cancer stage, tumor subtype, and race were associated with overall survival and breast cancer-specific survival.
 

What Does the New Study Add?

The current study included 2,836 men diagnosed with stage I to stage III HR+ breast cancer between 1990 and 2008, using data from the Surveillance, Epidemiology, and End Results (SEER) database.

“We found that in men with breast cancer, the risk of breast cancer mortality persists for at least 20 years and that [the risk] depends on traditional clinicopathologic factors, such as age, tumor size, nodal status and tumor grade,” Dr. J.P. Leone said in an interview.

“The prolonged risk [of breast-cancer specific mortality] over 20 years that we observed in our study is similar to that previously reported in women; however, the kinetics of the risk over the 20-year period appears different in men,” he emphasized.

The men in the study, especially those with a higher stage of disease, appeared to have a bimodal distribution of the BRCA mortality risk, he said.

Two peaks were identified, he explained; an early peak in mortality risk at approximately 4 years from diagnosis and another at approximately 11 years after diagnosis.

Although women with breast cancer had a prolonged risk of breast cancer mortality, “the kinetics of the risk does not include 2 peaks, even in women with higher stage of disease.” In women with higher stage breast cancer, the peak mortality risk occurs approximately 5 years after diagnosis, he said.

The reasons for the later peak in men remain unclear, the researchers wrote in the study, but possible explanations include nonadherence to endocrine therapy, differences in tumor biologic factors, and differences in the tumor microenvironment between men and women, they noted, in the discussion section.
 

What Drives the Risk?

Key factors for breast cancer-specific mortality were age, tumor stage, and tumor grade.

The cumulative 20-year risk of BCSM in the current study was 12.4%, 26.2%, and 46.0% for stage I, II, and III, respectively. The adjusted BCSM risk was increased in patients younger than 50 years, those with grade II or III/IV tumors, and those with stage II or III disease.
 

What Are the Limitations?

The current study by Leone and colleagues was limited by the relatively small subgroup sample of men with stage III and N3 disease, lack of data on the use of systemic therapies, and lack of data on human epidermal growth factor receptor 2 gene (ERBB2), the researchers wrote. However, the long-term follow-up strengthened the results, and the study is the first known to assess 20-year BCSM risk in men with nonmetastatic HR+ breast cancer.

What Do Oncologists Need to Know About the Study?

The study findings indicate that the risk of breast cancer mortality persists for 20 years in men with hormone receptor–positive breast cancer, Dr. J.P. Leone said in an interview. As in women, the risk depends on traditional clinicopathologic factors, he noted.

“However, the kinetics of that risk appears to be different between men and women. In order to reduce the breast cancer mortality risk in men with hormone receptor–positive breast cancer, it will be important for men to consider the benefits of the treatment options that may be indicated for their specific situation,” he said.

“I think early detection is also very important,” he emphasized. To that end, increased awareness of the possibility for breast cancer in men, as well as prompt intervention when breast cancer is suspected, will help to improve early detection when the risk of breast cancer mortality is lower, he added.
 

What Are the Next Steps for Research?

“I think our study underscores the need for additional research to improve our adjuvant therapy options in both men and women with hormone receptor-positive breast cancer, to reduce the risk of long-term mortality,” he said.

The study received no outside funding. Lead author Julieta Leone had no financial conflicts to disclose. Dr. José P. Leone disclosed receiving institutional grants from Kazia Therapeutics and Seagen unrelated to the current study.

Hospital mergers and acquisitions continue to garner intense scrutiny from lawmakers, with pressure likely to hold steady following the recent announcement of new antitrust guidelines and state and federal investigations into potential healthcare monopolies.

In December, the US Department of Justice (DOJ) and the Federal Trade Commission (FTC) released updated guidelines outlining the factors they consider when determining if a merger illegally monopolizes a local healthcare market or jeopardizes access to critical healthcare services.

Last week, the DOJ also announced a UnitedHealth Group antitrust probe, just months after the healthcare conglomerate’s workforce numbers indicated it is now affiliated with or employs 10% of the US physician workforce.

While the impact of the latest guidelines is yet to be seen, concerns over healthcare market consolidation are not new. Over the past two decades, mergers have attracted attention for contributing to a decline in independent hospitals, said Rachel M. Werner, MD, PhD, executive director of the Leonard Davis Institute of Health Economics at the University of Pennsylvania, Philadelphia, Pennsylvania.

“At this point, most hospitals are operating in a pretty concentrated market,” she said.

Here are five things to know about the current state of hospital mergers.

1. Record-Breaking Merger Enforcements

The DOJ and FTC reported the highest level of enforcement activity in over 20 years in fiscal year 2022 — the latest available data. Together, the agencies filed 50 merger enforcement actions and brought a record-breaking number of merger enforcement challenges, resulting in 11 approved actions, the restructuring or abandonment of seven mergers, and six business deals entering litigation.

Included in those statistics was a proposed merger between the two largest health systems in Rhode Island, Lifespan and Care New England Health System, which was abandoned after the FTC and the state Attorney General took steps to block it. the HCA branch in Utah Healthcare abandoned plans for to acquire five Salt Lake City area hospitals from competitor Steward Health Care System, as did RWJBarnabas Health after exploring a merger with Saint Peter's Healthcare System in New Jersey.

2. New Antitrust Guidelines Consider Labor Market

The new guidelines notably focus on labor competition, said Jody Boudreault, JD, attorney and chair of the Antitrust Life Sciences and Healthcare Group at Baker Botts law firm in Washington, DC. Health professionals typically have more employment opportunities in an urban area, unless hindered by restrictive noncompete agreements, and fewer options in rural settings.

In the Lifespan merger that fell through, Ms. Boudreault said that the newly created hospital system would have employed two thirds of Rhode Island's full-time nurses, limiting opportunities for local employment elsewhere.

“Going forward, I would expect federal authorities to review not only the competitive impact of the hospitals merging but also the competitive impact of the physician, and especially nursing, workforce,” she said.

FTC Chair Lina M. Khan noted similar labor market concerns.

In a statement to Congress, she said that hospital consolidation reduces options for employees, who fear “being blacklisted from further hiring in a system that controls many of the hospitals in the area” and “makes workers afraid to file complaints, organize their workplace, or leave before the end of a contract.”

3. Mergers Can Drive Care Costs Higher

When hospital markets become less competitive, the cost of care often increases. In Indiana, inpatient prices rose 13% in hospitals that merged. Another study found that prices at monopoly hospitals are 12% higher than in markets with four or more rivals. Even cross-market mergers, when hospitals in different geographic locations combine, can drive prices higher.

Dr. Werner told this news organization that more significant price hikes of 20-30% aren’t unheard of, with reimbursements by some commercial insurance companies rising as much as 50%. “That’s the direct price that the insurers pay, but the burden of those higher prices ultimately falls on patients through higher premiums,” she said.

Still, the American Hospital Association (AHA) says that mergers and acquisitions can significantly lower annual operating expenses per admission and reduce inpatient readmission rates and mortality measures. In comments to the FTC, the AHA stated that mergers could provide a lifeline for rural and community hospitals struggling with shrinking payer reimbursement and rising labor and supply costs. The business arrangements also could ensure these communities maintain continuity of care.

Although a cross-market merger may initially benefit cash-strapped rural hospitals, Dr. Werner urged caution.

“In the long run, it’s not clear that it is good for patients because we start to see decreased access to some types of service, like labor and delivery, which are services needed in rural markets,” she said.

4. Mergers to Watch in 2024

Ms. Boudreault, who represented RWJBarnabas in the abandoned Saint Peter’s transaction, says the courts widely accepted the old merger guidelines, and it will take time to see how the new measures are interpreted. “The guidelines don’t yet have the force of law, but they can be persuasive to a court.”

Looking ahead, she is watching how Steward Health Care navigates its impending financial collapse. The nation’s largest private for-profit health system was previously owned by private equity firm Cerberus Capital Management and includes nine Massachusetts hospitals plus entities in at least seven other states.

Ms. Boudreault also plans to monitor Jefferson Health’s intent to merge with Lehigh Valley Health Network. “It’s a pretty big deal because they would become a 30-hospital system,” said Ms. Boudreault. The newly formed network would become the largest employer in Philadelphia.

5. Merger and Acquisition Reversals Unlikely

Dr. Werner said that mergers and acquisitions are complicated business moves that are nearly impossible to undo once approved, so it makes sense for agencies to continue to evaluate them closely.

“The costs of healthcare are borne by us as a society,” she said. “We’re going to have to live with the ill effects of a consolidated market once we let hospitals merge, so they deserve additional scrutiny.”

A version of this article appeared on Medscape.com.

Hospital mergers and acquisitions continue to garner intense scrutiny from lawmakers, with pressure likely to hold steady following the recent announcement of new antitrust guidelines and state and federal investigations into potential healthcare monopolies.

In December, the US Department of Justice (DOJ) and the Federal Trade Commission (FTC) released updated guidelines outlining the factors they consider when determining if a merger illegally monopolizes a local healthcare market or jeopardizes access to critical healthcare services.

Last week, the DOJ also announced a UnitedHealth Group antitrust probe, just months after the healthcare conglomerate’s workforce numbers indicated it is now affiliated with or employs 10% of the US physician workforce.

While the impact of the latest guidelines is yet to be seen, concerns over healthcare market consolidation are not new. Over the past two decades, mergers have attracted attention for contributing to a decline in independent hospitals, said Rachel M. Werner, MD, PhD, executive director of the Leonard Davis Institute of Health Economics at the University of Pennsylvania, Philadelphia, Pennsylvania.

“At this point, most hospitals are operating in a pretty concentrated market,” she said.

Here are five things to know about the current state of hospital mergers.

1. Record-Breaking Merger Enforcements

The DOJ and FTC reported the highest level of enforcement activity in over 20 years in fiscal year 2022 — the latest available data. Together, the agencies filed 50 merger enforcement actions and brought a record-breaking number of merger enforcement challenges, resulting in 11 approved actions, the restructuring or abandonment of seven mergers, and six business deals entering litigation.

Included in those statistics was a proposed merger between the two largest health systems in Rhode Island, Lifespan and Care New England Health System, which was abandoned after the FTC and the state Attorney General took steps to block it. the HCA branch in Utah Healthcare abandoned plans for to acquire five Salt Lake City area hospitals from competitor Steward Health Care System, as did RWJBarnabas Health after exploring a merger with Saint Peter's Healthcare System in New Jersey.

2. New Antitrust Guidelines Consider Labor Market

The new guidelines notably focus on labor competition, said Jody Boudreault, JD, attorney and chair of the Antitrust Life Sciences and Healthcare Group at Baker Botts law firm in Washington, DC. Health professionals typically have more employment opportunities in an urban area, unless hindered by restrictive noncompete agreements, and fewer options in rural settings.

In the Lifespan merger that fell through, Ms. Boudreault said that the newly created hospital system would have employed two thirds of Rhode Island's full-time nurses, limiting opportunities for local employment elsewhere.

“Going forward, I would expect federal authorities to review not only the competitive impact of the hospitals merging but also the competitive impact of the physician, and especially nursing, workforce,” she said.

FTC Chair Lina M. Khan noted similar labor market concerns.

In a statement to Congress, she said that hospital consolidation reduces options for employees, who fear “being blacklisted from further hiring in a system that controls many of the hospitals in the area” and “makes workers afraid to file complaints, organize their workplace, or leave before the end of a contract.”

3. Mergers Can Drive Care Costs Higher

When hospital markets become less competitive, the cost of care often increases. In Indiana, inpatient prices rose 13% in hospitals that merged. Another study found that prices at monopoly hospitals are 12% higher than in markets with four or more rivals. Even cross-market mergers, when hospitals in different geographic locations combine, can drive prices higher.

Dr. Werner told this news organization that more significant price hikes of 20-30% aren’t unheard of, with reimbursements by some commercial insurance companies rising as much as 50%. “That’s the direct price that the insurers pay, but the burden of those higher prices ultimately falls on patients through higher premiums,” she said.

Still, the American Hospital Association (AHA) says that mergers and acquisitions can significantly lower annual operating expenses per admission and reduce inpatient readmission rates and mortality measures. In comments to the FTC, the AHA stated that mergers could provide a lifeline for rural and community hospitals struggling with shrinking payer reimbursement and rising labor and supply costs. The business arrangements also could ensure these communities maintain continuity of care.

Although a cross-market merger may initially benefit cash-strapped rural hospitals, Dr. Werner urged caution.

“In the long run, it’s not clear that it is good for patients because we start to see decreased access to some types of service, like labor and delivery, which are services needed in rural markets,” she said.

4. Mergers to Watch in 2024

Ms. Boudreault, who represented RWJBarnabas in the abandoned Saint Peter’s transaction, says the courts widely accepted the old merger guidelines, and it will take time to see how the new measures are interpreted. “The guidelines don’t yet have the force of law, but they can be persuasive to a court.”

Looking ahead, she is watching how Steward Health Care navigates its impending financial collapse. The nation’s largest private for-profit health system was previously owned by private equity firm Cerberus Capital Management and includes nine Massachusetts hospitals plus entities in at least seven other states.

Ms. Boudreault also plans to monitor Jefferson Health’s intent to merge with Lehigh Valley Health Network. “It’s a pretty big deal because they would become a 30-hospital system,” said Ms. Boudreault. The newly formed network would become the largest employer in Philadelphia.

5. Merger and Acquisition Reversals Unlikely

Dr. Werner said that mergers and acquisitions are complicated business moves that are nearly impossible to undo once approved, so it makes sense for agencies to continue to evaluate them closely.

“The costs of healthcare are borne by us as a society,” she said. “We’re going to have to live with the ill effects of a consolidated market once we let hospitals merge, so they deserve additional scrutiny.”

A version of this article appeared on Medscape.com.

Hospital mergers and acquisitions continue to garner intense scrutiny from lawmakers, with pressure likely to hold steady following the recent announcement of new antitrust guidelines and state and federal investigations into potential healthcare monopolies.

In December, the US Department of Justice (DOJ) and the Federal Trade Commission (FTC) released updated guidelines outlining the factors they consider when determining if a merger illegally monopolizes a local healthcare market or jeopardizes access to critical healthcare services.

Last week, the DOJ also announced a UnitedHealth Group antitrust probe, just months after the healthcare conglomerate’s workforce numbers indicated it is now affiliated with or employs 10% of the US physician workforce.

While the impact of the latest guidelines is yet to be seen, concerns over healthcare market consolidation are not new. Over the past two decades, mergers have attracted attention for contributing to a decline in independent hospitals, said Rachel M. Werner, MD, PhD, executive director of the Leonard Davis Institute of Health Economics at the University of Pennsylvania, Philadelphia, Pennsylvania.

“At this point, most hospitals are operating in a pretty concentrated market,” she said.

Here are five things to know about the current state of hospital mergers.

1. Record-Breaking Merger Enforcements

The DOJ and FTC reported the highest level of enforcement activity in over 20 years in fiscal year 2022 — the latest available data. Together, the agencies filed 50 merger enforcement actions and brought a record-breaking number of merger enforcement challenges, resulting in 11 approved actions, the restructuring or abandonment of seven mergers, and six business deals entering litigation.

Included in those statistics was a proposed merger between the two largest health systems in Rhode Island, Lifespan and Care New England Health System, which was abandoned after the FTC and the state Attorney General took steps to block it. the HCA branch in Utah Healthcare abandoned plans for to acquire five Salt Lake City area hospitals from competitor Steward Health Care System, as did RWJBarnabas Health after exploring a merger with Saint Peter's Healthcare System in New Jersey.

2. New Antitrust Guidelines Consider Labor Market

The new guidelines notably focus on labor competition, said Jody Boudreault, JD, attorney and chair of the Antitrust Life Sciences and Healthcare Group at Baker Botts law firm in Washington, DC. Health professionals typically have more employment opportunities in an urban area, unless hindered by restrictive noncompete agreements, and fewer options in rural settings.

In the Lifespan merger that fell through, Ms. Boudreault said that the newly created hospital system would have employed two thirds of Rhode Island's full-time nurses, limiting opportunities for local employment elsewhere.

“Going forward, I would expect federal authorities to review not only the competitive impact of the hospitals merging but also the competitive impact of the physician, and especially nursing, workforce,” she said.

FTC Chair Lina M. Khan noted similar labor market concerns.

In a statement to Congress, she said that hospital consolidation reduces options for employees, who fear “being blacklisted from further hiring in a system that controls many of the hospitals in the area” and “makes workers afraid to file complaints, organize their workplace, or leave before the end of a contract.”

3. Mergers Can Drive Care Costs Higher

When hospital markets become less competitive, the cost of care often increases. In Indiana, inpatient prices rose 13% in hospitals that merged. Another study found that prices at monopoly hospitals are 12% higher than in markets with four or more rivals. Even cross-market mergers, when hospitals in different geographic locations combine, can drive prices higher.

Dr. Werner told this news organization that more significant price hikes of 20-30% aren’t unheard of, with reimbursements by some commercial insurance companies rising as much as 50%. “That’s the direct price that the insurers pay, but the burden of those higher prices ultimately falls on patients through higher premiums,” she said.

Still, the American Hospital Association (AHA) says that mergers and acquisitions can significantly lower annual operating expenses per admission and reduce inpatient readmission rates and mortality measures. In comments to the FTC, the AHA stated that mergers could provide a lifeline for rural and community hospitals struggling with shrinking payer reimbursement and rising labor and supply costs. The business arrangements also could ensure these communities maintain continuity of care.

Although a cross-market merger may initially benefit cash-strapped rural hospitals, Dr. Werner urged caution.

“In the long run, it’s not clear that it is good for patients because we start to see decreased access to some types of service, like labor and delivery, which are services needed in rural markets,” she said.

4. Mergers to Watch in 2024

Ms. Boudreault, who represented RWJBarnabas in the abandoned Saint Peter’s transaction, says the courts widely accepted the old merger guidelines, and it will take time to see how the new measures are interpreted. “The guidelines don’t yet have the force of law, but they can be persuasive to a court.”

Looking ahead, she is watching how Steward Health Care navigates its impending financial collapse. The nation’s largest private for-profit health system was previously owned by private equity firm Cerberus Capital Management and includes nine Massachusetts hospitals plus entities in at least seven other states.

Ms. Boudreault also plans to monitor Jefferson Health’s intent to merge with Lehigh Valley Health Network. “It’s a pretty big deal because they would become a 30-hospital system,” said Ms. Boudreault. The newly formed network would become the largest employer in Philadelphia.

5. Merger and Acquisition Reversals Unlikely

Dr. Werner said that mergers and acquisitions are complicated business moves that are nearly impossible to undo once approved, so it makes sense for agencies to continue to evaluate them closely.

“The costs of healthcare are borne by us as a society,” she said. “We’re going to have to live with the ill effects of a consolidated market once we let hospitals merge, so they deserve additional scrutiny.”

A version of this article appeared on Medscape.com.

TOPLINE:

Continued denosumab treatment is associated with a lower risk for diabetes in adults with osteoporosis older than 65 years, found a large-scale cohort study in Taiwan.

METHODOLOGY:

• Denosumab, used in osteoporosis treatment, has been suggested to improve glycemic parameters, but clinical evidence of its effects on diabetes risk is limited and inconsistent.
• Using data from Taiwan’s National Health Insurance Research Database (NHIRD), the study asked if continued denosumab treatment (60 mg) for osteoporosis reduced the risk for diabetes compared to those who discontinued denosumab.
• Researchers included all new users of denosumab between 2012 and 2019 who had no prior history of malignant neoplasms, Paget disease, or diabetes requiring antidiabetic medication.
• Patients in the treatment group (n = 34,255), who received a second dose of denosumab within 225 days, were 1:1 propensity matched with a control group (n = 34,255) of patients who had discontinued denosumab after the first dose.
• The 68,510 patients (mean age, 77.7 years; 84.3% women) were followed up for a mean of 1.9 years. The primary outcome was new-onset diabetes that required treatment with any antidiabetic drug.

TAKEAWAY:

• Continued denosumab treatment vs its discontinuation was associated with a lower risk for incident diabetes (hazard ratio [HR], 0.84; 95% CI, 0.78-0.90).
• In patients aged 65 years or older who were on continued treatment of denosumab, the risk for diabetes was lower (HR, 0.80; 95% CI, 0.75-0.85) but not among those younger than 65 years.
• A reduced risk for diabetes with continued denosumab treatment was observed in both men (HR, 0.85; 95% CI, 0.73-0.97) and women (HR, 0.81; 95% CI, 0.76-0.86).
• Lower diabetes risk with continued denosumab treatment was observed regardless of comorbidities, such as dyslipidemia, hypertension, ischemic heart disease, or kidney failure.

IN PRACTICE:

“Given the high osteoporosis prevalence, the extensive use of antiosteoporosis medications, and the negative effect of diabetes on both patient health and healthcare system burdens in the global aging population, our findings possess substantial clinical and public health significance,” the authors wrote.

SOURCE:

This study was led by Huei-Kai Huang, MD, Department of Family Medicine and Department of Medical Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan, and published online in JAMA Network Open.

LIMITATIONS:

The research used claims-based data, so some clinical details, such as lifestyle, substance use, prediabetes weight status, and laboratory results, were not included. Owing to the anonymity policy of the NHIRD, patients could not be directly evaluated to validate incident diabetes. The study included the Taiwanese population, so the findings may not be generalizable to other populations. In Taiwan, the threshold for reimbursement of initiating denosumab treatment for osteoporosis includes below-normal bone density scores and a hip or vertebral fracture.

DISCLOSURES:

This study was supported by grants from the National Science and Technology Council of Taiwan and the National Health Research Institutes of Taiwan and a grant from the Buddhist Tzu Chi Medical Foundation. The corresponding author and a coauthor disclosed receiving funds from Amgen, Novartis, Pfizer, Sanofi, Takeda, and AbbVie, all outside the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Continued denosumab treatment is associated with a lower risk for diabetes in adults with osteoporosis older than 65 years, found a large-scale cohort study in Taiwan.

METHODOLOGY:

• Denosumab, used in osteoporosis treatment, has been suggested to improve glycemic parameters, but clinical evidence of its effects on diabetes risk is limited and inconsistent.
• Using data from Taiwan’s National Health Insurance Research Database (NHIRD), the study asked if continued denosumab treatment (60 mg) for osteoporosis reduced the risk for diabetes compared to those who discontinued denosumab.
• Researchers included all new users of denosumab between 2012 and 2019 who had no prior history of malignant neoplasms, Paget disease, or diabetes requiring antidiabetic medication.
• Patients in the treatment group (n = 34,255), who received a second dose of denosumab within 225 days, were 1:1 propensity matched with a control group (n = 34,255) of patients who had discontinued denosumab after the first dose.
• The 68,510 patients (mean age, 77.7 years; 84.3% women) were followed up for a mean of 1.9 years. The primary outcome was new-onset diabetes that required treatment with any antidiabetic drug.

TAKEAWAY:

• Continued denosumab treatment vs its discontinuation was associated with a lower risk for incident diabetes (hazard ratio [HR], 0.84; 95% CI, 0.78-0.90).
• In patients aged 65 years or older who were on continued treatment of denosumab, the risk for diabetes was lower (HR, 0.80; 95% CI, 0.75-0.85) but not among those younger than 65 years.
• A reduced risk for diabetes with continued denosumab treatment was observed in both men (HR, 0.85; 95% CI, 0.73-0.97) and women (HR, 0.81; 95% CI, 0.76-0.86).
• Lower diabetes risk with continued denosumab treatment was observed regardless of comorbidities, such as dyslipidemia, hypertension, ischemic heart disease, or kidney failure.

IN PRACTICE:

“Given the high osteoporosis prevalence, the extensive use of antiosteoporosis medications, and the negative effect of diabetes on both patient health and healthcare system burdens in the global aging population, our findings possess substantial clinical and public health significance,” the authors wrote.

SOURCE:

This study was led by Huei-Kai Huang, MD, Department of Family Medicine and Department of Medical Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan, and published online in JAMA Network Open.

LIMITATIONS:

The research used claims-based data, so some clinical details, such as lifestyle, substance use, prediabetes weight status, and laboratory results, were not included. Owing to the anonymity policy of the NHIRD, patients could not be directly evaluated to validate incident diabetes. The study included the Taiwanese population, so the findings may not be generalizable to other populations. In Taiwan, the threshold for reimbursement of initiating denosumab treatment for osteoporosis includes below-normal bone density scores and a hip or vertebral fracture.

DISCLOSURES:

This study was supported by grants from the National Science and Technology Council of Taiwan and the National Health Research Institutes of Taiwan and a grant from the Buddhist Tzu Chi Medical Foundation. The corresponding author and a coauthor disclosed receiving funds from Amgen, Novartis, Pfizer, Sanofi, Takeda, and AbbVie, all outside the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Continued denosumab treatment is associated with a lower risk for diabetes in adults with osteoporosis older than 65 years, found a large-scale cohort study in Taiwan.

METHODOLOGY:

• Denosumab, used in osteoporosis treatment, has been suggested to improve glycemic parameters, but clinical evidence of its effects on diabetes risk is limited and inconsistent.
• Using data from Taiwan’s National Health Insurance Research Database (NHIRD), the study asked if continued denosumab treatment (60 mg) for osteoporosis reduced the risk for diabetes compared to those who discontinued denosumab.
• Researchers included all new users of denosumab between 2012 and 2019 who had no prior history of malignant neoplasms, Paget disease, or diabetes requiring antidiabetic medication.
• Patients in the treatment group (n = 34,255), who received a second dose of denosumab within 225 days, were 1:1 propensity matched with a control group (n = 34,255) of patients who had discontinued denosumab after the first dose.
• The 68,510 patients (mean age, 77.7 years; 84.3% women) were followed up for a mean of 1.9 years. The primary outcome was new-onset diabetes that required treatment with any antidiabetic drug.

TAKEAWAY:

• Continued denosumab treatment vs its discontinuation was associated with a lower risk for incident diabetes (hazard ratio [HR], 0.84; 95% CI, 0.78-0.90).
• In patients aged 65 years or older who were on continued treatment of denosumab, the risk for diabetes was lower (HR, 0.80; 95% CI, 0.75-0.85) but not among those younger than 65 years.
• A reduced risk for diabetes with continued denosumab treatment was observed in both men (HR, 0.85; 95% CI, 0.73-0.97) and women (HR, 0.81; 95% CI, 0.76-0.86).
• Lower diabetes risk with continued denosumab treatment was observed regardless of comorbidities, such as dyslipidemia, hypertension, ischemic heart disease, or kidney failure.

IN PRACTICE:

“Given the high osteoporosis prevalence, the extensive use of antiosteoporosis medications, and the negative effect of diabetes on both patient health and healthcare system burdens in the global aging population, our findings possess substantial clinical and public health significance,” the authors wrote.

SOURCE:

This study was led by Huei-Kai Huang, MD, Department of Family Medicine and Department of Medical Research, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan, and published online in JAMA Network Open.

LIMITATIONS:

The research used claims-based data, so some clinical details, such as lifestyle, substance use, prediabetes weight status, and laboratory results, were not included. Owing to the anonymity policy of the NHIRD, patients could not be directly evaluated to validate incident diabetes. The study included the Taiwanese population, so the findings may not be generalizable to other populations. In Taiwan, the threshold for reimbursement of initiating denosumab treatment for osteoporosis includes below-normal bone density scores and a hip or vertebral fracture.

DISCLOSURES:

This study was supported by grants from the National Science and Technology Council of Taiwan and the National Health Research Institutes of Taiwan and a grant from the Buddhist Tzu Chi Medical Foundation. The corresponding author and a coauthor disclosed receiving funds from Amgen, Novartis, Pfizer, Sanofi, Takeda, and AbbVie, all outside the submitted work.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) announced the removal of the endocrine-disrupting chemicals (EDCs) per- and polyfluoroalkyl substances (PFAS) from food packaging.

Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.

In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.

PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
 

Endocrine Society Report Sounds the Alarm About PFAS and Others

The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.

“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.

The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.

At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”

Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”

While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.

Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.

Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.

“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
 

New Data on Four Classes of EDCs

Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.

The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.

Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.

Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.

The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
 

‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’

Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.

The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”

The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) announced the removal of the endocrine-disrupting chemicals (EDCs) per- and polyfluoroalkyl substances (PFAS) from food packaging.

Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.

In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.

PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
 

Endocrine Society Report Sounds the Alarm About PFAS and Others

The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.

“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.

The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.

At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”

Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”

While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.

Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.

Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.

“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
 

New Data on Four Classes of EDCs

Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.

The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.

Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.

Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.

The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
 

‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’

Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.

The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”

The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) announced the removal of the endocrine-disrupting chemicals (EDCs) per- and polyfluoroalkyl substances (PFAS) from food packaging.

Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.

In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.

PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
 

Endocrine Society Report Sounds the Alarm About PFAS and Others

The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.

“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.

The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.

At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”

Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”

While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.

Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.

Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.

“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
 

New Data on Four Classes of EDCs

Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.

The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.

Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.

Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.

The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
 

‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’

Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.

The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”

The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.

A version of this article appeared on Medscape.com.

Letícia Soares was infected with COVID-19 in April 2020, in the final year of postdoctoral studies in disease ecology at a Canadian University. What started with piercing migraines and severe fatigue in 2020 soon spiraled into a myriad of long COVID symptoms: Gastrointestinal issues, sleep problems, joint and muscle pain, along with unexpected menstrual changes.

After an absence of menstrual bleeding and its usual signs, she later suffered from severe periods and symptoms that worsened her long COVID condition. “It just baffled me,” said Soares, now 39. “It was debilitating.”

Cases like Soares’s are leading scientists to spend more time trying to understand the biological sex disparity in chronic illnesses such as long COVID that until recently have all but been ignored. According to the Centers for Disease Control and Prevention, long COVID affects nearly twice as many women as men.

What’s more, up to two thirds of female patients with long COVID report an increase in symptoms related to menstruation, which suggests a possible link between sex hormone fluctuations and immune dysfunction in the illness.

“These illnesses are underfunded and understudied relative to their disease burdens,” said Beth Pollack, a research scientist at the Massachusetts Institute of Technology, Cambridge, Massachusetts, who studies complex chronic illnesses.

Addressing knowledge gaps, especially around sex differences, could significantly improve our understanding of complex chronic illnesses, said Pollack, who coauthored a 2023 literature review of female reproductive health impacts of long COVID.

Emerging ‘Menstrual Science’ Could Be Key

There is a critical need, she said, for studies on these illnesses to include considerations of sex differences, hormones, reproductive phases, and reproductive conditions. This research could potentially inform doctors and other clinicians or lead to treatments, both for reproductive symptoms and for the illnesses themselves.

Pollack noted that reproductive symptoms are prevalent across a group of infection-associated chronic illnesses she studies, all of which disproportionately affect women. These associated conditions, traditionally studied in isolation, share pathologies like reproductive health concerns, signaling a need for focused research on their shared mechanisms.

Recognizing this critical gap, “menstrual science” is emerging as a pivotal area of study, aiming to connect these dots through focused research on hormonal influences.

Researchers at the University of Melbourne, Melbourne, Australia, for example, are studying whether hormones play a role in causing or worsening the symptoms of long COVID. By comparing hormone levels in people with these conditions with those in healthy people and by tracking how symptoms change with hormone levels over time and across menstrual cycles, scientists hope to find patterns that could help diagnose these conditions more easily and lead to new treatments. They’re also examining how hormonal life phases such as puberty, pregnancy, or perimenopause and hormone treatments like birth control might affect these illnesses.

How Gender and Long COVID Intertwine

The pathologies of long COVID, affecting at least 65 million people worldwide, currently focus on four hypotheses: Persistent viral infection, reactivation of dormant viruses (such as common herpes viruses), inflammation-related damage to tissues and organs, and autoimmunity (the body attacking itself).

It’s this last reason that holds some of the most interesting clues on biological sex differences, said Akiko Iwasaki, PhD, a Yale University, New Haven, Connecticut, immunologist who has led numerous research breakthroughs on long COVID since the start of the pandemic. Women have two X chromosomes, for example, and although one is inactivated, the inactivation is incomplete.

Some cells still express genes from the “inactivated genes” on the X chromosome, Iwasaki said. Those include key immune genes, which trigger a more robust response to infections and vaccinations but also predispose them to autoimmune reactions. “It comes at the cost of triggering too much immune response,” Iwasaki said.

Sex hormones also factor in. Testosterone, which is higher in males, is immunosuppressive, so it can dampen immune responses, Iwasaki said. That may contribute to making males more likely to get severe acute infections of COVID-19 but have fewer long-term effects.

Estrogen, on the other hand, is known to enhance the immune response. It can increase the production of antibodies and the activation of T cells, which are critical for fighting off infections. This heightened immune response, however, might also contribute to the persistent inflammation observed in long COVID, where the immune system continues to react even after the acute infection has resolved.

Sex-Specific Symptoms and Marginalized Communities

Of the more than 200 symptoms long haulers experience, Iwasaki said, several are also sex-specific. A recent draft study by Iwasaki and another leading COVID researcher, David Putrino, PhD, at Mount Sinai Health System in New York City, shows hair loss as one of the most female-dominant symptoms and sexual dysfunction among males.

In examining sex differences, another question is why long COVID rates in the trans community are disproportionately high. One of the reasons Iwasaki’s lab is looking at testosterone closely is because anecdotal evidence from female-to-male trans individuals indicates that testosterone therapy improved their long COVID symptoms significantly. It also raises the possibility that hormone therapy could help.

However, patients and advocates say it’s also important to consider socioeconomic factors in the trans community. “We need to start at this population and social structure level to understand why trans people over and over are put in harm’s way,” said JD Davids, a trans patient-researcher with long COVID and the cofounder and codirector of Strategies for High Impact and its Long COVID Justice project.

For trans people, said Davids, risk factors for both severe COVID and long COVID include being part of low-income groups, belonging to marginalized racial and ethnic communities, and living in crowded environments such as shelters or prisons.

The disproportionate impact of long COVID on marginalized communities, especially when seen through the lens of historical medical neglect, also demands attention, said Iwasaki. “Women used to be labeled hysteric when they complained about these kinds of symptoms.”

Where It All Leads

The possibility of diagnosing long COVID with a simple blood test could radically change some doctors’ false perceptions that it is not a real condition, Iwasaki said, ensuring it is recognized and treated with the seriousness it deserves.

“I feel like we need to get there with long COVID. If we can order a blood test and say somebody has a long COVID because of these values, then suddenly the diseases become medically explainable,” Iwasaki added. This advancement is critical for propelling research forward, she said, refining treatment approaches — including those that target sex-specific hormone, immunity, and inflammation issues — and improving the well-being of those living with long COVID.

This hope resonates with scientists like Pollack, who recently led the first National Institutes of Health-sponsored research webinar on less studied pathologies in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and long COVID, and with the experiences of individuals like Soares, who navigates through the unpredictable nature of both of these conditions with resilience.

“This illness never ceases to surprise me in how it changes my body. I feel like it’s a constant adaptation,” said Soares. Now living in Salvador, Brazil, her daily life has dramatically shifted to the confines of her home.

“It’s how I have more predictability in my symptoms,” she said, pointing out the pressing need for the scientific advancements that Iwasaki envisions and a deepening of our understanding of the disease’s impacts on patients’ lives.

A version of this article appeared on Medscape.com.

Letícia Soares was infected with COVID-19 in April 2020, in the final year of postdoctoral studies in disease ecology at a Canadian University. What started with piercing migraines and severe fatigue in 2020 soon spiraled into a myriad of long COVID symptoms: Gastrointestinal issues, sleep problems, joint and muscle pain, along with unexpected menstrual changes.

After an absence of menstrual bleeding and its usual signs, she later suffered from severe periods and symptoms that worsened her long COVID condition. “It just baffled me,” said Soares, now 39. “It was debilitating.”

Cases like Soares’s are leading scientists to spend more time trying to understand the biological sex disparity in chronic illnesses such as long COVID that until recently have all but been ignored. According to the Centers for Disease Control and Prevention, long COVID affects nearly twice as many women as men.

What’s more, up to two thirds of female patients with long COVID report an increase in symptoms related to menstruation, which suggests a possible link between sex hormone fluctuations and immune dysfunction in the illness.

“These illnesses are underfunded and understudied relative to their disease burdens,” said Beth Pollack, a research scientist at the Massachusetts Institute of Technology, Cambridge, Massachusetts, who studies complex chronic illnesses.

Addressing knowledge gaps, especially around sex differences, could significantly improve our understanding of complex chronic illnesses, said Pollack, who coauthored a 2023 literature review of female reproductive health impacts of long COVID.

Emerging ‘Menstrual Science’ Could Be Key

There is a critical need, she said, for studies on these illnesses to include considerations of sex differences, hormones, reproductive phases, and reproductive conditions. This research could potentially inform doctors and other clinicians or lead to treatments, both for reproductive symptoms and for the illnesses themselves.

Pollack noted that reproductive symptoms are prevalent across a group of infection-associated chronic illnesses she studies, all of which disproportionately affect women. These associated conditions, traditionally studied in isolation, share pathologies like reproductive health concerns, signaling a need for focused research on their shared mechanisms.

Recognizing this critical gap, “menstrual science” is emerging as a pivotal area of study, aiming to connect these dots through focused research on hormonal influences.

Researchers at the University of Melbourne, Melbourne, Australia, for example, are studying whether hormones play a role in causing or worsening the symptoms of long COVID. By comparing hormone levels in people with these conditions with those in healthy people and by tracking how symptoms change with hormone levels over time and across menstrual cycles, scientists hope to find patterns that could help diagnose these conditions more easily and lead to new treatments. They’re also examining how hormonal life phases such as puberty, pregnancy, or perimenopause and hormone treatments like birth control might affect these illnesses.

How Gender and Long COVID Intertwine

The pathologies of long COVID, affecting at least 65 million people worldwide, currently focus on four hypotheses: Persistent viral infection, reactivation of dormant viruses (such as common herpes viruses), inflammation-related damage to tissues and organs, and autoimmunity (the body attacking itself).

It’s this last reason that holds some of the most interesting clues on biological sex differences, said Akiko Iwasaki, PhD, a Yale University, New Haven, Connecticut, immunologist who has led numerous research breakthroughs on long COVID since the start of the pandemic. Women have two X chromosomes, for example, and although one is inactivated, the inactivation is incomplete.

Some cells still express genes from the “inactivated genes” on the X chromosome, Iwasaki said. Those include key immune genes, which trigger a more robust response to infections and vaccinations but also predispose them to autoimmune reactions. “It comes at the cost of triggering too much immune response,” Iwasaki said.

Sex hormones also factor in. Testosterone, which is higher in males, is immunosuppressive, so it can dampen immune responses, Iwasaki said. That may contribute to making males more likely to get severe acute infections of COVID-19 but have fewer long-term effects.

Estrogen, on the other hand, is known to enhance the immune response. It can increase the production of antibodies and the activation of T cells, which are critical for fighting off infections. This heightened immune response, however, might also contribute to the persistent inflammation observed in long COVID, where the immune system continues to react even after the acute infection has resolved.

Sex-Specific Symptoms and Marginalized Communities

Of the more than 200 symptoms long haulers experience, Iwasaki said, several are also sex-specific. A recent draft study by Iwasaki and another leading COVID researcher, David Putrino, PhD, at Mount Sinai Health System in New York City, shows hair loss as one of the most female-dominant symptoms and sexual dysfunction among males.

In examining sex differences, another question is why long COVID rates in the trans community are disproportionately high. One of the reasons Iwasaki’s lab is looking at testosterone closely is because anecdotal evidence from female-to-male trans individuals indicates that testosterone therapy improved their long COVID symptoms significantly. It also raises the possibility that hormone therapy could help.

However, patients and advocates say it’s also important to consider socioeconomic factors in the trans community. “We need to start at this population and social structure level to understand why trans people over and over are put in harm’s way,” said JD Davids, a trans patient-researcher with long COVID and the cofounder and codirector of Strategies for High Impact and its Long COVID Justice project.

For trans people, said Davids, risk factors for both severe COVID and long COVID include being part of low-income groups, belonging to marginalized racial and ethnic communities, and living in crowded environments such as shelters or prisons.

The disproportionate impact of long COVID on marginalized communities, especially when seen through the lens of historical medical neglect, also demands attention, said Iwasaki. “Women used to be labeled hysteric when they complained about these kinds of symptoms.”

Where It All Leads

The possibility of diagnosing long COVID with a simple blood test could radically change some doctors’ false perceptions that it is not a real condition, Iwasaki said, ensuring it is recognized and treated with the seriousness it deserves.

“I feel like we need to get there with long COVID. If we can order a blood test and say somebody has a long COVID because of these values, then suddenly the diseases become medically explainable,” Iwasaki added. This advancement is critical for propelling research forward, she said, refining treatment approaches — including those that target sex-specific hormone, immunity, and inflammation issues — and improving the well-being of those living with long COVID.

This hope resonates with scientists like Pollack, who recently led the first National Institutes of Health-sponsored research webinar on less studied pathologies in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and long COVID, and with the experiences of individuals like Soares, who navigates through the unpredictable nature of both of these conditions with resilience.

“This illness never ceases to surprise me in how it changes my body. I feel like it’s a constant adaptation,” said Soares. Now living in Salvador, Brazil, her daily life has dramatically shifted to the confines of her home.

“It’s how I have more predictability in my symptoms,” she said, pointing out the pressing need for the scientific advancements that Iwasaki envisions and a deepening of our understanding of the disease’s impacts on patients’ lives.

A version of this article appeared on Medscape.com.

Letícia Soares was infected with COVID-19 in April 2020, in the final year of postdoctoral studies in disease ecology at a Canadian University. What started with piercing migraines and severe fatigue in 2020 soon spiraled into a myriad of long COVID symptoms: Gastrointestinal issues, sleep problems, joint and muscle pain, along with unexpected menstrual changes.

After an absence of menstrual bleeding and its usual signs, she later suffered from severe periods and symptoms that worsened her long COVID condition. “It just baffled me,” said Soares, now 39. “It was debilitating.”

Cases like Soares’s are leading scientists to spend more time trying to understand the biological sex disparity in chronic illnesses such as long COVID that until recently have all but been ignored. According to the Centers for Disease Control and Prevention, long COVID affects nearly twice as many women as men.

What’s more, up to two thirds of female patients with long COVID report an increase in symptoms related to menstruation, which suggests a possible link between sex hormone fluctuations and immune dysfunction in the illness.

“These illnesses are underfunded and understudied relative to their disease burdens,” said Beth Pollack, a research scientist at the Massachusetts Institute of Technology, Cambridge, Massachusetts, who studies complex chronic illnesses.

Addressing knowledge gaps, especially around sex differences, could significantly improve our understanding of complex chronic illnesses, said Pollack, who coauthored a 2023 literature review of female reproductive health impacts of long COVID.

Emerging ‘Menstrual Science’ Could Be Key

There is a critical need, she said, for studies on these illnesses to include considerations of sex differences, hormones, reproductive phases, and reproductive conditions. This research could potentially inform doctors and other clinicians or lead to treatments, both for reproductive symptoms and for the illnesses themselves.

Pollack noted that reproductive symptoms are prevalent across a group of infection-associated chronic illnesses she studies, all of which disproportionately affect women. These associated conditions, traditionally studied in isolation, share pathologies like reproductive health concerns, signaling a need for focused research on their shared mechanisms.

Recognizing this critical gap, “menstrual science” is emerging as a pivotal area of study, aiming to connect these dots through focused research on hormonal influences.

Researchers at the University of Melbourne, Melbourne, Australia, for example, are studying whether hormones play a role in causing or worsening the symptoms of long COVID. By comparing hormone levels in people with these conditions with those in healthy people and by tracking how symptoms change with hormone levels over time and across menstrual cycles, scientists hope to find patterns that could help diagnose these conditions more easily and lead to new treatments. They’re also examining how hormonal life phases such as puberty, pregnancy, or perimenopause and hormone treatments like birth control might affect these illnesses.

How Gender and Long COVID Intertwine

The pathologies of long COVID, affecting at least 65 million people worldwide, currently focus on four hypotheses: Persistent viral infection, reactivation of dormant viruses (such as common herpes viruses), inflammation-related damage to tissues and organs, and autoimmunity (the body attacking itself).

It’s this last reason that holds some of the most interesting clues on biological sex differences, said Akiko Iwasaki, PhD, a Yale University, New Haven, Connecticut, immunologist who has led numerous research breakthroughs on long COVID since the start of the pandemic. Women have two X chromosomes, for example, and although one is inactivated, the inactivation is incomplete.

Some cells still express genes from the “inactivated genes” on the X chromosome, Iwasaki said. Those include key immune genes, which trigger a more robust response to infections and vaccinations but also predispose them to autoimmune reactions. “It comes at the cost of triggering too much immune response,” Iwasaki said.

Sex hormones also factor in. Testosterone, which is higher in males, is immunosuppressive, so it can dampen immune responses, Iwasaki said. That may contribute to making males more likely to get severe acute infections of COVID-19 but have fewer long-term effects.

Estrogen, on the other hand, is known to enhance the immune response. It can increase the production of antibodies and the activation of T cells, which are critical for fighting off infections. This heightened immune response, however, might also contribute to the persistent inflammation observed in long COVID, where the immune system continues to react even after the acute infection has resolved.

Sex-Specific Symptoms and Marginalized Communities

Of the more than 200 symptoms long haulers experience, Iwasaki said, several are also sex-specific. A recent draft study by Iwasaki and another leading COVID researcher, David Putrino, PhD, at Mount Sinai Health System in New York City, shows hair loss as one of the most female-dominant symptoms and sexual dysfunction among males.

In examining sex differences, another question is why long COVID rates in the trans community are disproportionately high. One of the reasons Iwasaki’s lab is looking at testosterone closely is because anecdotal evidence from female-to-male trans individuals indicates that testosterone therapy improved their long COVID symptoms significantly. It also raises the possibility that hormone therapy could help.

However, patients and advocates say it’s also important to consider socioeconomic factors in the trans community. “We need to start at this population and social structure level to understand why trans people over and over are put in harm’s way,” said JD Davids, a trans patient-researcher with long COVID and the cofounder and codirector of Strategies for High Impact and its Long COVID Justice project.

For trans people, said Davids, risk factors for both severe COVID and long COVID include being part of low-income groups, belonging to marginalized racial and ethnic communities, and living in crowded environments such as shelters or prisons.

The disproportionate impact of long COVID on marginalized communities, especially when seen through the lens of historical medical neglect, also demands attention, said Iwasaki. “Women used to be labeled hysteric when they complained about these kinds of symptoms.”

Where It All Leads

The possibility of diagnosing long COVID with a simple blood test could radically change some doctors’ false perceptions that it is not a real condition, Iwasaki said, ensuring it is recognized and treated with the seriousness it deserves.

“I feel like we need to get there with long COVID. If we can order a blood test and say somebody has a long COVID because of these values, then suddenly the diseases become medically explainable,” Iwasaki added. This advancement is critical for propelling research forward, she said, refining treatment approaches — including those that target sex-specific hormone, immunity, and inflammation issues — and improving the well-being of those living with long COVID.

This hope resonates with scientists like Pollack, who recently led the first National Institutes of Health-sponsored research webinar on less studied pathologies in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and long COVID, and with the experiences of individuals like Soares, who navigates through the unpredictable nature of both of these conditions with resilience.

“This illness never ceases to surprise me in how it changes my body. I feel like it’s a constant adaptation,” said Soares. Now living in Salvador, Brazil, her daily life has dramatically shifted to the confines of her home.

“It’s how I have more predictability in my symptoms,” she said, pointing out the pressing need for the scientific advancements that Iwasaki envisions and a deepening of our understanding of the disease’s impacts on patients’ lives.

A version of this article appeared on Medscape.com.

Physicians’ negative online reviews — fair or unfair — can scare away new patients. But practices don’t have to sit idly by and watch their revenue shrink.

Increasingly, they’re turning to apps and automated systems like DearDoc, Rater8, and LoyalHealth that ask satisfied patients to post reviews. The goal: To counteract the effect of negative reviews.

Not all of these systems are effective, according to physicians who’ve used them. Asking patients for reviews is still not fully accepted, either. Still, some apps have proved their worth, doctors say.

Karen Horton, MD, a plastic surgeon in San Francisco, California, has used an automated system for 3 years. Even though reviews from plastic surgery patients can be difficult to get, Dr. Horton said, she has accumulated 535, with an average rating of just under 5 stars on a 1- to 5-star scale.

Dr. Horton, who speaks on the topic, said unfair negative reviews are a problem that needs addressing.

“A bad review sometimes says more about the patient than the provider,” she said. “Patients can use online reviews to vent about some perceived misgiving.”

Automated requests can address this problem. “The best way to deal with negative reviews is to ask average patients to post reviews,” she said. “These patients are more likely to be positive, but they wouldn’t leave a review unless asked.”

How Automated Systems Work

A variety of vendors provide an automated review request process to practices and hospitals. DearDoc, Loyal Health, Rater8, and Simple Interact work with healthcare providers, while Birdeye, Reputation, and Thrive Management work with all businesses.

Typically, these vendors access the practice’s electronic health record to get patients’ contact information and the daily appointment schedule to know which patients to contact. Patients are contacted after their appointment and are given the opportunity to go directly to a review site and post.

Inviting patients digitally rather than in person may seem unwelcoming, but many people prefer it, said Fred Horton, president of AMGA consulting in Alexandria, Virginia, a subsidiary of the American Medical Group Association. (He is not related to Karen Horton.)

“People tend to be more honest and detailed when responding to an automated message than to a person,” Mr. Horton told this news organization. “And younger patients actually prefer digital communications.”

But Mike Coppola, vice president of AMGA consulting, isn’t keen about automation.

He said practices can instead assign staff to ask patients to post reviews or an office can use signage displaying a Quick Response (QR) code, a two-dimensional matrix often used in restaurants to access a menu. Patients who put their smartphone cameras over the code are taken directly to a review site.

Still, staff would still need to help each patient access the site to be as effective as automation, and a QR invitation may be ignored. Pat Pazmino, MD, a plastic surgeon in Miami, Florida, told this news organization his office displays QR codes for reviews, but “I’m not sure many patients really use them.”

Some automated systems can go too far. Dr. Pazmino said a vendor he hired several years ago contacted “every patient who had ever called my office. A lot of them were annoyed.”

He said the service generated only 20 or 30 reviews, and some were negative. He did not like that he was soliciting patients to make negative reviews. He canceled the service.

What Is the Cost and Return on Investment?

“Our system makes it as easy as possible for patients to place reviews,” said Ravi Kalidindi, CEO of Simple Interact, a Dallas-based vendor that markets to doctors.

Dr. Kalidindi said Simple Interact charges $95-$145 per provider per month, depending on how the tool is used. For each dollar in cost, the practice typically earns $10 in extra revenue, he said.

Orrin Franko, MD, a hand surgeon in San Leandro, California, started using an automated patient review tool several years ago. He said that after installation received 10 reviews per month, all 5-star. “Now we have well over 700 reviews that generate close to $500,000 a year for our three-doctor practice,” he said.

Karen Horton reports more modest results. One new review comes in every 3-4 weeks. “Getting online reviews is a challenge for plastic surgeons,” he said. “Most patients are very private about having work done.”

Dr. Kalidindi reported that very few patients respond to Simple Interact’s invitation, but the numbers add up. “Typically, 3 of 100 patients contacted will ultimately post a positive review,” he said. “That means that a practice that sees 600 patients a month could get 18 positive reviews a month.”

Practices can also build their own systems and avoid vendors’ monthly fees. Dr. Franko built his own system, while Dr. Horton contracted with SILVR Agency, a digital marketing company in Solana Beach, California, to build hers for a one-time cost of about $3000.

Why Should Doctors Care About Online Reviews?

Online review sites for doctors include HealthGrades, RateMDs, Realself, Vitals, WebMD, and Zocdoc. (Medscape Medical News is part of WebMD.) Potential patients also consult general review sites like Facebook, Google My Business, and Yelp.

Consumers tend to prefer doctors who have many reviews, but most doctors get very few. One survey found that the average doctor has only seven online reviews, while competitors may have hundreds.

Having too few reviews also means that just one or two negative reviews can produce a poor average rating. It’s virtually impossible to remove negative reviews, and they can have a big impact. A 1-star rating reduces consumers’ clicks by 11%, according to Brightlocal, a company that surveys consumers’ use of online ratings.

Online reviews also influence Google searches, even when consumers never access a review site, said Lee Rensch, product director at Loyal Health, an Atlanta, Georgia–based vendor that works exclusively with hospitals.

By far the most common way to find a doctor is to use Google to search for doctors “near me,” Mr. Rensch told this news organization. The Google search brings up a ranked list of doctors, based partly on each doctor’s ratings on review sites.

Mr. Rensch said 15%-20% of Google’s ranking involves the number of reviews the doctor has, the average star rating, and the newness of the reviews. Other factors include whether the provider has responded to reviews and the description of the practice, he said.

How many people use the internet to find doctors? One survey found that 72% of healthcare consumers do so. Furthermore, healthcare ranks second in the most common use of reviews, after service businesses and before restaurants, according to a Brightlocal survey.

Is it OK to Ask for Reviews?

Dr. Franko said asking for reviews is still not fully accepted. “There remains a spectrum of opinions and emotions regarding the appropriateness of ‘soliciting’ online reviews from patients,” he said.

Dr. Horton said review sites are also divided. “Google encourages businesses to remind customers to leave reviews, but Yelp discourages it,” she said. “It wants reviews to be organic and spontaneous.”

“I don’t think this is a problem,” said E. Scot Davis, a practice management consultant in Little Rock, Arkansas, and a board member of the Large Urology Group Practice Association. “Not enough people leave positive reviews, so it’s a way of balancing out the impact of a few people who make negative reviews.”

Indeed, other businesses routinely ask for online reviews and customers are often willing to oblige. Brightlocal reported that in 2022, 80% of consumers said they were prompted by local businesses to leave a review and 65% did so.

Some physicians may wonder whether it’s ethical to limit requests for reviews to patients who had positive experiences. Some vendors first ask patients about their experiences and then invite only those with positive ones to post.

Dr. Kalidindi said Simple Interact asks patients about their experiences as a way to help practices improve their services. He said patients’ experiences aren’t normally used to cull out dissatisfied patients unless the customer asks for it.

Loyal Health’s tool does not ask patients about their experiences, according to Loyal Health President Brian Gresh. He told this news organization he is opposed to culling negative reviewers and said it’s against Google policy.

Mr. Coppola at AMGA Consulting also opposes the practice. “It’s misleading not to ask people who had a bad experience,” he said. “Besides, if you only have glowing reviews, consumers would be suspicious.”

Meanwhile, everyone agrees that practices shouldn’t pay for online reviews. Dr. Horton said she believes this would be considered unprofessional conduct by the Medical Board of California.

Conclusion

Automated systems have helped practices attain more and better online reviews, boosting their revenue. Although some frown on the idea of prompting patients to leave reviews, others say it is necessary because some negative online reviews can be unfair and harm practices.

A version of this article appeared on Medscape.com.

Physicians’ negative online reviews — fair or unfair — can scare away new patients. But practices don’t have to sit idly by and watch their revenue shrink.

Increasingly, they’re turning to apps and automated systems like DearDoc, Rater8, and LoyalHealth that ask satisfied patients to post reviews. The goal: To counteract the effect of negative reviews.

Not all of these systems are effective, according to physicians who’ve used them. Asking patients for reviews is still not fully accepted, either. Still, some apps have proved their worth, doctors say.

Karen Horton, MD, a plastic surgeon in San Francisco, California, has used an automated system for 3 years. Even though reviews from plastic surgery patients can be difficult to get, Dr. Horton said, she has accumulated 535, with an average rating of just under 5 stars on a 1- to 5-star scale.

Dr. Horton, who speaks on the topic, said unfair negative reviews are a problem that needs addressing.

“A bad review sometimes says more about the patient than the provider,” she said. “Patients can use online reviews to vent about some perceived misgiving.”

Automated requests can address this problem. “The best way to deal with negative reviews is to ask average patients to post reviews,” she said. “These patients are more likely to be positive, but they wouldn’t leave a review unless asked.”

How Automated Systems Work

A variety of vendors provide an automated review request process to practices and hospitals. DearDoc, Loyal Health, Rater8, and Simple Interact work with healthcare providers, while Birdeye, Reputation, and Thrive Management work with all businesses.

Typically, these vendors access the practice’s electronic health record to get patients’ contact information and the daily appointment schedule to know which patients to contact. Patients are contacted after their appointment and are given the opportunity to go directly to a review site and post.

Inviting patients digitally rather than in person may seem unwelcoming, but many people prefer it, said Fred Horton, president of AMGA consulting in Alexandria, Virginia, a subsidiary of the American Medical Group Association. (He is not related to Karen Horton.)

“People tend to be more honest and detailed when responding to an automated message than to a person,” Mr. Horton told this news organization. “And younger patients actually prefer digital communications.”

But Mike Coppola, vice president of AMGA consulting, isn’t keen about automation.

He said practices can instead assign staff to ask patients to post reviews or an office can use signage displaying a Quick Response (QR) code, a two-dimensional matrix often used in restaurants to access a menu. Patients who put their smartphone cameras over the code are taken directly to a review site.

Still, staff would still need to help each patient access the site to be as effective as automation, and a QR invitation may be ignored. Pat Pazmino, MD, a plastic surgeon in Miami, Florida, told this news organization his office displays QR codes for reviews, but “I’m not sure many patients really use them.”

Some automated systems can go too far. Dr. Pazmino said a vendor he hired several years ago contacted “every patient who had ever called my office. A lot of them were annoyed.”

He said the service generated only 20 or 30 reviews, and some were negative. He did not like that he was soliciting patients to make negative reviews. He canceled the service.

What Is the Cost and Return on Investment?

“Our system makes it as easy as possible for patients to place reviews,” said Ravi Kalidindi, CEO of Simple Interact, a Dallas-based vendor that markets to doctors.

Dr. Kalidindi said Simple Interact charges $95-$145 per provider per month, depending on how the tool is used. For each dollar in cost, the practice typically earns $10 in extra revenue, he said.

Orrin Franko, MD, a hand surgeon in San Leandro, California, started using an automated patient review tool several years ago. He said that after installation received 10 reviews per month, all 5-star. “Now we have well over 700 reviews that generate close to $500,000 a year for our three-doctor practice,” he said.

Karen Horton reports more modest results. One new review comes in every 3-4 weeks. “Getting online reviews is a challenge for plastic surgeons,” he said. “Most patients are very private about having work done.”

Dr. Kalidindi reported that very few patients respond to Simple Interact’s invitation, but the numbers add up. “Typically, 3 of 100 patients contacted will ultimately post a positive review,” he said. “That means that a practice that sees 600 patients a month could get 18 positive reviews a month.”

Practices can also build their own systems and avoid vendors’ monthly fees. Dr. Franko built his own system, while Dr. Horton contracted with SILVR Agency, a digital marketing company in Solana Beach, California, to build hers for a one-time cost of about $3000.

Why Should Doctors Care About Online Reviews?

Online review sites for doctors include HealthGrades, RateMDs, Realself, Vitals, WebMD, and Zocdoc. (Medscape Medical News is part of WebMD.) Potential patients also consult general review sites like Facebook, Google My Business, and Yelp.

Consumers tend to prefer doctors who have many reviews, but most doctors get very few. One survey found that the average doctor has only seven online reviews, while competitors may have hundreds.

Having too few reviews also means that just one or two negative reviews can produce a poor average rating. It’s virtually impossible to remove negative reviews, and they can have a big impact. A 1-star rating reduces consumers’ clicks by 11%, according to Brightlocal, a company that surveys consumers’ use of online ratings.

Online reviews also influence Google searches, even when consumers never access a review site, said Lee Rensch, product director at Loyal Health, an Atlanta, Georgia–based vendor that works exclusively with hospitals.

By far the most common way to find a doctor is to use Google to search for doctors “near me,” Mr. Rensch told this news organization. The Google search brings up a ranked list of doctors, based partly on each doctor’s ratings on review sites.

Mr. Rensch said 15%-20% of Google’s ranking involves the number of reviews the doctor has, the average star rating, and the newness of the reviews. Other factors include whether the provider has responded to reviews and the description of the practice, he said.

How many people use the internet to find doctors? One survey found that 72% of healthcare consumers do so. Furthermore, healthcare ranks second in the most common use of reviews, after service businesses and before restaurants, according to a Brightlocal survey.

Is it OK to Ask for Reviews?

Dr. Franko said asking for reviews is still not fully accepted. “There remains a spectrum of opinions and emotions regarding the appropriateness of ‘soliciting’ online reviews from patients,” he said.

Dr. Horton said review sites are also divided. “Google encourages businesses to remind customers to leave reviews, but Yelp discourages it,” she said. “It wants reviews to be organic and spontaneous.”

“I don’t think this is a problem,” said E. Scot Davis, a practice management consultant in Little Rock, Arkansas, and a board member of the Large Urology Group Practice Association. “Not enough people leave positive reviews, so it’s a way of balancing out the impact of a few people who make negative reviews.”

Indeed, other businesses routinely ask for online reviews and customers are often willing to oblige. Brightlocal reported that in 2022, 80% of consumers said they were prompted by local businesses to leave a review and 65% did so.

Some physicians may wonder whether it’s ethical to limit requests for reviews to patients who had positive experiences. Some vendors first ask patients about their experiences and then invite only those with positive ones to post.

Dr. Kalidindi said Simple Interact asks patients about their experiences as a way to help practices improve their services. He said patients’ experiences aren’t normally used to cull out dissatisfied patients unless the customer asks for it.

Loyal Health’s tool does not ask patients about their experiences, according to Loyal Health President Brian Gresh. He told this news organization he is opposed to culling negative reviewers and said it’s against Google policy.

Mr. Coppola at AMGA Consulting also opposes the practice. “It’s misleading not to ask people who had a bad experience,” he said. “Besides, if you only have glowing reviews, consumers would be suspicious.”

Meanwhile, everyone agrees that practices shouldn’t pay for online reviews. Dr. Horton said she believes this would be considered unprofessional conduct by the Medical Board of California.

Conclusion

Automated systems have helped practices attain more and better online reviews, boosting their revenue. Although some frown on the idea of prompting patients to leave reviews, others say it is necessary because some negative online reviews can be unfair and harm practices.

A version of this article appeared on Medscape.com.

Physicians’ negative online reviews — fair or unfair — can scare away new patients. But practices don’t have to sit idly by and watch their revenue shrink.

Increasingly, they’re turning to apps and automated systems like DearDoc, Rater8, and LoyalHealth that ask satisfied patients to post reviews. The goal: To counteract the effect of negative reviews.

Not all of these systems are effective, according to physicians who’ve used them. Asking patients for reviews is still not fully accepted, either. Still, some apps have proved their worth, doctors say.

Karen Horton, MD, a plastic surgeon in San Francisco, California, has used an automated system for 3 years. Even though reviews from plastic surgery patients can be difficult to get, Dr. Horton said, she has accumulated 535, with an average rating of just under 5 stars on a 1- to 5-star scale.

Dr. Horton, who speaks on the topic, said unfair negative reviews are a problem that needs addressing.

“A bad review sometimes says more about the patient than the provider,” she said. “Patients can use online reviews to vent about some perceived misgiving.”

Automated requests can address this problem. “The best way to deal with negative reviews is to ask average patients to post reviews,” she said. “These patients are more likely to be positive, but they wouldn’t leave a review unless asked.”

How Automated Systems Work

A variety of vendors provide an automated review request process to practices and hospitals. DearDoc, Loyal Health, Rater8, and Simple Interact work with healthcare providers, while Birdeye, Reputation, and Thrive Management work with all businesses.

Typically, these vendors access the practice’s electronic health record to get patients’ contact information and the daily appointment schedule to know which patients to contact. Patients are contacted after their appointment and are given the opportunity to go directly to a review site and post.

Inviting patients digitally rather than in person may seem unwelcoming, but many people prefer it, said Fred Horton, president of AMGA consulting in Alexandria, Virginia, a subsidiary of the American Medical Group Association. (He is not related to Karen Horton.)

“People tend to be more honest and detailed when responding to an automated message than to a person,” Mr. Horton told this news organization. “And younger patients actually prefer digital communications.”

But Mike Coppola, vice president of AMGA consulting, isn’t keen about automation.

He said practices can instead assign staff to ask patients to post reviews or an office can use signage displaying a Quick Response (QR) code, a two-dimensional matrix often used in restaurants to access a menu. Patients who put their smartphone cameras over the code are taken directly to a review site.

Still, staff would still need to help each patient access the site to be as effective as automation, and a QR invitation may be ignored. Pat Pazmino, MD, a plastic surgeon in Miami, Florida, told this news organization his office displays QR codes for reviews, but “I’m not sure many patients really use them.”

Some automated systems can go too far. Dr. Pazmino said a vendor he hired several years ago contacted “every patient who had ever called my office. A lot of them were annoyed.”

He said the service generated only 20 or 30 reviews, and some were negative. He did not like that he was soliciting patients to make negative reviews. He canceled the service.

What Is the Cost and Return on Investment?

“Our system makes it as easy as possible for patients to place reviews,” said Ravi Kalidindi, CEO of Simple Interact, a Dallas-based vendor that markets to doctors.

Dr. Kalidindi said Simple Interact charges $95-$145 per provider per month, depending on how the tool is used. For each dollar in cost, the practice typically earns $10 in extra revenue, he said.

Orrin Franko, MD, a hand surgeon in San Leandro, California, started using an automated patient review tool several years ago. He said that after installation received 10 reviews per month, all 5-star. “Now we have well over 700 reviews that generate close to $500,000 a year for our three-doctor practice,” he said.

Karen Horton reports more modest results. One new review comes in every 3-4 weeks. “Getting online reviews is a challenge for plastic surgeons,” he said. “Most patients are very private about having work done.”

Dr. Kalidindi reported that very few patients respond to Simple Interact’s invitation, but the numbers add up. “Typically, 3 of 100 patients contacted will ultimately post a positive review,” he said. “That means that a practice that sees 600 patients a month could get 18 positive reviews a month.”

Practices can also build their own systems and avoid vendors’ monthly fees. Dr. Franko built his own system, while Dr. Horton contracted with SILVR Agency, a digital marketing company in Solana Beach, California, to build hers for a one-time cost of about $3000.

Why Should Doctors Care About Online Reviews?

Online review sites for doctors include HealthGrades, RateMDs, Realself, Vitals, WebMD, and Zocdoc. (Medscape Medical News is part of WebMD.) Potential patients also consult general review sites like Facebook, Google My Business, and Yelp.

Consumers tend to prefer doctors who have many reviews, but most doctors get very few. One survey found that the average doctor has only seven online reviews, while competitors may have hundreds.

Having too few reviews also means that just one or two negative reviews can produce a poor average rating. It’s virtually impossible to remove negative reviews, and they can have a big impact. A 1-star rating reduces consumers’ clicks by 11%, according to Brightlocal, a company that surveys consumers’ use of online ratings.

Online reviews also influence Google searches, even when consumers never access a review site, said Lee Rensch, product director at Loyal Health, an Atlanta, Georgia–based vendor that works exclusively with hospitals.

By far the most common way to find a doctor is to use Google to search for doctors “near me,” Mr. Rensch told this news organization. The Google search brings up a ranked list of doctors, based partly on each doctor’s ratings on review sites.

Mr. Rensch said 15%-20% of Google’s ranking involves the number of reviews the doctor has, the average star rating, and the newness of the reviews. Other factors include whether the provider has responded to reviews and the description of the practice, he said.

How many people use the internet to find doctors? One survey found that 72% of healthcare consumers do so. Furthermore, healthcare ranks second in the most common use of reviews, after service businesses and before restaurants, according to a Brightlocal survey.

Is it OK to Ask for Reviews?

Dr. Franko said asking for reviews is still not fully accepted. “There remains a spectrum of opinions and emotions regarding the appropriateness of ‘soliciting’ online reviews from patients,” he said.

Dr. Horton said review sites are also divided. “Google encourages businesses to remind customers to leave reviews, but Yelp discourages it,” she said. “It wants reviews to be organic and spontaneous.”

“I don’t think this is a problem,” said E. Scot Davis, a practice management consultant in Little Rock, Arkansas, and a board member of the Large Urology Group Practice Association. “Not enough people leave positive reviews, so it’s a way of balancing out the impact of a few people who make negative reviews.”

Indeed, other businesses routinely ask for online reviews and customers are often willing to oblige. Brightlocal reported that in 2022, 80% of consumers said they were prompted by local businesses to leave a review and 65% did so.

Some physicians may wonder whether it’s ethical to limit requests for reviews to patients who had positive experiences. Some vendors first ask patients about their experiences and then invite only those with positive ones to post.

Dr. Kalidindi said Simple Interact asks patients about their experiences as a way to help practices improve their services. He said patients’ experiences aren’t normally used to cull out dissatisfied patients unless the customer asks for it.

Loyal Health’s tool does not ask patients about their experiences, according to Loyal Health President Brian Gresh. He told this news organization he is opposed to culling negative reviewers and said it’s against Google policy.

Mr. Coppola at AMGA Consulting also opposes the practice. “It’s misleading not to ask people who had a bad experience,” he said. “Besides, if you only have glowing reviews, consumers would be suspicious.”

Meanwhile, everyone agrees that practices shouldn’t pay for online reviews. Dr. Horton said she believes this would be considered unprofessional conduct by the Medical Board of California.

Conclusion

Automated systems have helped practices attain more and better online reviews, boosting their revenue. Although some frown on the idea of prompting patients to leave reviews, others say it is necessary because some negative online reviews can be unfair and harm practices.

A version of this article appeared on Medscape.com.

Long-term adherence to a plant-based diet was not tied to a greater risk of hip fracture and some plant-based regimens may actually reduce the risk, a large cohort study of postmenopausal women in the United States suggested.

Not all plant-centered regimens are healthful, however, and this study factored dietary quality into risk.

Writing in JAMA Network Open, the study authors compared the lowest to highest quintiles of Plant-Based Diet Index scores. They found the most recent intake of a healthy plant-based diet (hPDI) to be associated with a somewhat lower (21%) risk of fracture while the most recent intake of its unhealthy counterpart (uPDI) was linked to a somewhat higher (28%) risk.

“In addition, higher baseline scores in the uPDI were associated with higher risk of hip fracture,” wrote the researchers, led by Mercedes Sotos Prieto, PhD, a nutritional epidemiologist in the Department of Preventive Medicine and Public Health at the Autonomous University of Madrid.

Plant-based diets, characterized by higher consumption of plant foods and lower or no intake of animal foods, have raised concerns about their potential harm to bone health. In a recent meta-analysis, vegetarians, but particularly vegans with no consumption of any animal food, had a higher fracture risk and lower bone mineral density compared with omnivores.

Another study found that compared with meat eaters, fish eaters and vegetarians had a higher risk of hip fractures. These analyses, however, did not assess the quality of the plant-based diets.

Courtesy Dr. Sotos Prieto

“We hypothesized that the differences in the quality of the plant-based diets — whole grains, fruits, and vegetables vs refined carbohydrates or snacks, which are both plant-based but very different, would be important in the association for the risk of hip fracture,” Dr. Sotos Prieto said in an interview.
 

Study details

Her study drew on data from 70,285 postmenopausal White women who were in the US Nurses’ Health Study from 1984 through 2014; data were analyzed from Jan. 1 to July 31, 2023.

The mean age of the nurses was 54.92 years, and 2038 cases of hip fracture were reported during the study over as long as 30 years of follow-up.

Healthy plant foods included whole grains, fruits, vegetables, nuts, legumes, vegetable oils, and tea or coffee and received positive scores, whereas less healthy plant foods such as fruit juices, sweetened beverages, refined grains, potatoes, sweets, or desserts and animal foods received reversed scores. Dietary and lifestyle information was collected by self-reported questionnaires.

Individuals with higher hPDI scores were leaner, more physically active, less likely to be smokers, and more likely to use vitamin and calcium supplements. Not surprisingly, they also had higher intakes of dietary calcium and healthy plant foods and had lower intake of less healthy plant foods. “It’s plausible that reverse causation may account for the risk associations, as individuals with underlying health conditions that predisposed them to higher fracture risk may have changed their diet,” Dr. Sotos Prieto said. “In addition, baseline diet may reflect diet early on, which could be an important predictor of bone mineral density when there was more active bone turnover.”

Lack of information precluded adjustment for the use of anti-osteoporotic medication.

Neither the hPDI, with a hazard ratio (HR) for highest vs lowest quintile of 0.97 (95% confidence interval, 0.83-1.14) nor the uPDI, with an HR for highest vs lowest quintile of 1.02 (95% CI, 0.87-1.20) for diet adherence over the long term was associated with hip fracture risk.

For recent dietary intake in the highest vs lowest quintiles, however, the hPDI was associated with a 21% lower risk of hip fracture: HR, 0.79 (95% CI, 0.68-0.92; P = .02 for trend). In contrast, the uPDI was associated with a 28% higher risk: HR, 1.28 (95% CI, 1.09-1.51; P = .008 for trend).

Future studies in other populations are needed to confirm the results and enhance their generalizability, Dr. Sotos Prieto said. “Investigating the temporal dynamics of dietary patterns and their effects by examining how recent dietary changes may impact health outcomes over different timeframes is important.” In the meantime, people wishing to follow a plant-based diet should make sure it features high-quality foods.

This work was supported by Instituto de Salud Carlos III, State Secretary of Research, Development and Innovation of Spain, and the European Research Funds and European Social Fund, the Agencia Estatal de Investigación, the National Institutes of Health, and a Ramón y Cajal contract from the Ministry of Science, Innovation, and Universities. A coauthor reported a patent pending. No other disclosures were reported.

Long-term adherence to a plant-based diet was not tied to a greater risk of hip fracture and some plant-based regimens may actually reduce the risk, a large cohort study of postmenopausal women in the United States suggested.

Not all plant-centered regimens are healthful, however, and this study factored dietary quality into risk.

Writing in JAMA Network Open, the study authors compared the lowest to highest quintiles of Plant-Based Diet Index scores. They found the most recent intake of a healthy plant-based diet (hPDI) to be associated with a somewhat lower (21%) risk of fracture while the most recent intake of its unhealthy counterpart (uPDI) was linked to a somewhat higher (28%) risk.

“In addition, higher baseline scores in the uPDI were associated with higher risk of hip fracture,” wrote the researchers, led by Mercedes Sotos Prieto, PhD, a nutritional epidemiologist in the Department of Preventive Medicine and Public Health at the Autonomous University of Madrid.

Plant-based diets, characterized by higher consumption of plant foods and lower or no intake of animal foods, have raised concerns about their potential harm to bone health. In a recent meta-analysis, vegetarians, but particularly vegans with no consumption of any animal food, had a higher fracture risk and lower bone mineral density compared with omnivores.

Another study found that compared with meat eaters, fish eaters and vegetarians had a higher risk of hip fractures. These analyses, however, did not assess the quality of the plant-based diets.

Courtesy Dr. Sotos Prieto

“We hypothesized that the differences in the quality of the plant-based diets — whole grains, fruits, and vegetables vs refined carbohydrates or snacks, which are both plant-based but very different, would be important in the association for the risk of hip fracture,” Dr. Sotos Prieto said in an interview.
 

Study details

Her study drew on data from 70,285 postmenopausal White women who were in the US Nurses’ Health Study from 1984 through 2014; data were analyzed from Jan. 1 to July 31, 2023.

The mean age of the nurses was 54.92 years, and 2038 cases of hip fracture were reported during the study over as long as 30 years of follow-up.

Healthy plant foods included whole grains, fruits, vegetables, nuts, legumes, vegetable oils, and tea or coffee and received positive scores, whereas less healthy plant foods such as fruit juices, sweetened beverages, refined grains, potatoes, sweets, or desserts and animal foods received reversed scores. Dietary and lifestyle information was collected by self-reported questionnaires.

Individuals with higher hPDI scores were leaner, more physically active, less likely to be smokers, and more likely to use vitamin and calcium supplements. Not surprisingly, they also had higher intakes of dietary calcium and healthy plant foods and had lower intake of less healthy plant foods. “It’s plausible that reverse causation may account for the risk associations, as individuals with underlying health conditions that predisposed them to higher fracture risk may have changed their diet,” Dr. Sotos Prieto said. “In addition, baseline diet may reflect diet early on, which could be an important predictor of bone mineral density when there was more active bone turnover.”

Lack of information precluded adjustment for the use of anti-osteoporotic medication.

Neither the hPDI, with a hazard ratio (HR) for highest vs lowest quintile of 0.97 (95% confidence interval, 0.83-1.14) nor the uPDI, with an HR for highest vs lowest quintile of 1.02 (95% CI, 0.87-1.20) for diet adherence over the long term was associated with hip fracture risk.

For recent dietary intake in the highest vs lowest quintiles, however, the hPDI was associated with a 21% lower risk of hip fracture: HR, 0.79 (95% CI, 0.68-0.92; P = .02 for trend). In contrast, the uPDI was associated with a 28% higher risk: HR, 1.28 (95% CI, 1.09-1.51; P = .008 for trend).

Future studies in other populations are needed to confirm the results and enhance their generalizability, Dr. Sotos Prieto said. “Investigating the temporal dynamics of dietary patterns and their effects by examining how recent dietary changes may impact health outcomes over different timeframes is important.” In the meantime, people wishing to follow a plant-based diet should make sure it features high-quality foods.

This work was supported by Instituto de Salud Carlos III, State Secretary of Research, Development and Innovation of Spain, and the European Research Funds and European Social Fund, the Agencia Estatal de Investigación, the National Institutes of Health, and a Ramón y Cajal contract from the Ministry of Science, Innovation, and Universities. A coauthor reported a patent pending. No other disclosures were reported.

Long-term adherence to a plant-based diet was not tied to a greater risk of hip fracture and some plant-based regimens may actually reduce the risk, a large cohort study of postmenopausal women in the United States suggested.

Not all plant-centered regimens are healthful, however, and this study factored dietary quality into risk.

Writing in JAMA Network Open, the study authors compared the lowest to highest quintiles of Plant-Based Diet Index scores. They found the most recent intake of a healthy plant-based diet (hPDI) to be associated with a somewhat lower (21%) risk of fracture while the most recent intake of its unhealthy counterpart (uPDI) was linked to a somewhat higher (28%) risk.

“In addition, higher baseline scores in the uPDI were associated with higher risk of hip fracture,” wrote the researchers, led by Mercedes Sotos Prieto, PhD, a nutritional epidemiologist in the Department of Preventive Medicine and Public Health at the Autonomous University of Madrid.

Plant-based diets, characterized by higher consumption of plant foods and lower or no intake of animal foods, have raised concerns about their potential harm to bone health. In a recent meta-analysis, vegetarians, but particularly vegans with no consumption of any animal food, had a higher fracture risk and lower bone mineral density compared with omnivores.

Another study found that compared with meat eaters, fish eaters and vegetarians had a higher risk of hip fractures. These analyses, however, did not assess the quality of the plant-based diets.

Courtesy Dr. Sotos Prieto

“We hypothesized that the differences in the quality of the plant-based diets — whole grains, fruits, and vegetables vs refined carbohydrates or snacks, which are both plant-based but very different, would be important in the association for the risk of hip fracture,” Dr. Sotos Prieto said in an interview.
 

Study details

Her study drew on data from 70,285 postmenopausal White women who were in the US Nurses’ Health Study from 1984 through 2014; data were analyzed from Jan. 1 to July 31, 2023.

The mean age of the nurses was 54.92 years, and 2038 cases of hip fracture were reported during the study over as long as 30 years of follow-up.

Healthy plant foods included whole grains, fruits, vegetables, nuts, legumes, vegetable oils, and tea or coffee and received positive scores, whereas less healthy plant foods such as fruit juices, sweetened beverages, refined grains, potatoes, sweets, or desserts and animal foods received reversed scores. Dietary and lifestyle information was collected by self-reported questionnaires.

Individuals with higher hPDI scores were leaner, more physically active, less likely to be smokers, and more likely to use vitamin and calcium supplements. Not surprisingly, they also had higher intakes of dietary calcium and healthy plant foods and had lower intake of less healthy plant foods. “It’s plausible that reverse causation may account for the risk associations, as individuals with underlying health conditions that predisposed them to higher fracture risk may have changed their diet,” Dr. Sotos Prieto said. “In addition, baseline diet may reflect diet early on, which could be an important predictor of bone mineral density when there was more active bone turnover.”

Lack of information precluded adjustment for the use of anti-osteoporotic medication.

Neither the hPDI, with a hazard ratio (HR) for highest vs lowest quintile of 0.97 (95% confidence interval, 0.83-1.14) nor the uPDI, with an HR for highest vs lowest quintile of 1.02 (95% CI, 0.87-1.20) for diet adherence over the long term was associated with hip fracture risk.

For recent dietary intake in the highest vs lowest quintiles, however, the hPDI was associated with a 21% lower risk of hip fracture: HR, 0.79 (95% CI, 0.68-0.92; P = .02 for trend). In contrast, the uPDI was associated with a 28% higher risk: HR, 1.28 (95% CI, 1.09-1.51; P = .008 for trend).

Future studies in other populations are needed to confirm the results and enhance their generalizability, Dr. Sotos Prieto said. “Investigating the temporal dynamics of dietary patterns and their effects by examining how recent dietary changes may impact health outcomes over different timeframes is important.” In the meantime, people wishing to follow a plant-based diet should make sure it features high-quality foods.

This work was supported by Instituto de Salud Carlos III, State Secretary of Research, Development and Innovation of Spain, and the European Research Funds and European Social Fund, the Agencia Estatal de Investigación, the National Institutes of Health, and a Ramón y Cajal contract from the Ministry of Science, Innovation, and Universities. A coauthor reported a patent pending. No other disclosures were reported.

TOPLINE:

Taking a prescription opioid for pain management during pregnancy is associated with an increased risk for spontaneous preterm birth, data from a new case-control study of over 25,000 Medicaid patients showed.

METHODOLOGY:

• Researchers retrospectively reviewed data on pregnant patients enrolled in Tennessee Medicaid who experienced birth of a single baby at ≥ 24 weeks gestation (25,391 with opioid use disorder and 225,696 without).
• Median age of participants was 23 years; 58.1% were non-Hispanic White, 38.7% Black, 2.6% Hispanic, and 0.5% Asian.
• Controls were matched based on pregnancy start date, race, ethnicity, age at delivery (within 2 years), and history of prior preterm birth.
• Sensitivity analysis included the exclusion of opioid prescriptions dispensed within 3 days of the index date to account for potential opioid prescribing associated with labor pain.

TAKEAWAY:

• A total of 18,702 patients (7.4%) filled an opioid prescription during the 60 days prior to the index date.
• Each doubling of opioid morphine milligram equivalents (MMEs) prescribed during the 60 days was associated with a 4% increase in the odds of spontaneous preterm birth compared with no opioid exposure in the matched controls (adjusted odds ratio [aOR], 1.04; 95% CI, 1.01-1.08).
• Overall, 1573 pregnancies filled prescriptions for 900 MMEs or greater, which was associated with at least a 21% increased risk for spontaneous preterm birth compared with no opioid exposure (aOR, 1.21; 95% CI, 1.10-1.33).
• Researchers found no significant difference in odds of spontaneous preterm birth among included opioid types after adjusting for confounders and opioid MMD.

IN PRACTICE:

“This association may appear modest, especially considering that common, one-time prescriptions often fall in the 150-225 MME range, but these findings may provide more caution when prescribing multiple, higher strength opioids,” the authors wrote. “We also caution against the conclusion that lower doses, especially those below 100 MME, are safe; the confidence bands over the low dose range still include odds ratios that are consistent with meaningful harm.”

SOURCE:

Sarah S. Osmundson, MD, MS, of the Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee, was the senior and corresponding author on the study. The study was published online on February 14 in JAMA Network Open.

LIMITATIONS:

Data are based on opioids prescribed and lack detail on actual use of opioids and nonprescription analgesics. Findings may not be generalizable to other populations or settings outside Medicaid.

DISCLOSURES:

No source of study funding listed. Dr. Osmundson reported receiving grant support from the National Institute on Drug Abuse during the conduct of the study. The other authors’ disclosures are listed on the original paper.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Taking a prescription opioid for pain management during pregnancy is associated with an increased risk for spontaneous preterm birth, data from a new case-control study of over 25,000 Medicaid patients showed.

METHODOLOGY:

• Researchers retrospectively reviewed data on pregnant patients enrolled in Tennessee Medicaid who experienced birth of a single baby at ≥ 24 weeks gestation (25,391 with opioid use disorder and 225,696 without).
• Median age of participants was 23 years; 58.1% were non-Hispanic White, 38.7% Black, 2.6% Hispanic, and 0.5% Asian.
• Controls were matched based on pregnancy start date, race, ethnicity, age at delivery (within 2 years), and history of prior preterm birth.
• Sensitivity analysis included the exclusion of opioid prescriptions dispensed within 3 days of the index date to account for potential opioid prescribing associated with labor pain.

TAKEAWAY:

• A total of 18,702 patients (7.4%) filled an opioid prescription during the 60 days prior to the index date.
• Each doubling of opioid morphine milligram equivalents (MMEs) prescribed during the 60 days was associated with a 4% increase in the odds of spontaneous preterm birth compared with no opioid exposure in the matched controls (adjusted odds ratio [aOR], 1.04; 95% CI, 1.01-1.08).
• Overall, 1573 pregnancies filled prescriptions for 900 MMEs or greater, which was associated with at least a 21% increased risk for spontaneous preterm birth compared with no opioid exposure (aOR, 1.21; 95% CI, 1.10-1.33).
• Researchers found no significant difference in odds of spontaneous preterm birth among included opioid types after adjusting for confounders and opioid MMD.

IN PRACTICE:

“This association may appear modest, especially considering that common, one-time prescriptions often fall in the 150-225 MME range, but these findings may provide more caution when prescribing multiple, higher strength opioids,” the authors wrote. “We also caution against the conclusion that lower doses, especially those below 100 MME, are safe; the confidence bands over the low dose range still include odds ratios that are consistent with meaningful harm.”

SOURCE:

Sarah S. Osmundson, MD, MS, of the Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee, was the senior and corresponding author on the study. The study was published online on February 14 in JAMA Network Open.

LIMITATIONS:

Data are based on opioids prescribed and lack detail on actual use of opioids and nonprescription analgesics. Findings may not be generalizable to other populations or settings outside Medicaid.

DISCLOSURES:

No source of study funding listed. Dr. Osmundson reported receiving grant support from the National Institute on Drug Abuse during the conduct of the study. The other authors’ disclosures are listed on the original paper.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Taking a prescription opioid for pain management during pregnancy is associated with an increased risk for spontaneous preterm birth, data from a new case-control study of over 25,000 Medicaid patients showed.

METHODOLOGY:

• Researchers retrospectively reviewed data on pregnant patients enrolled in Tennessee Medicaid who experienced birth of a single baby at ≥ 24 weeks gestation (25,391 with opioid use disorder and 225,696 without).
• Median age of participants was 23 years; 58.1% were non-Hispanic White, 38.7% Black, 2.6% Hispanic, and 0.5% Asian.
• Controls were matched based on pregnancy start date, race, ethnicity, age at delivery (within 2 years), and history of prior preterm birth.
• Sensitivity analysis included the exclusion of opioid prescriptions dispensed within 3 days of the index date to account for potential opioid prescribing associated with labor pain.

TAKEAWAY:

• A total of 18,702 patients (7.4%) filled an opioid prescription during the 60 days prior to the index date.
• Each doubling of opioid morphine milligram equivalents (MMEs) prescribed during the 60 days was associated with a 4% increase in the odds of spontaneous preterm birth compared with no opioid exposure in the matched controls (adjusted odds ratio [aOR], 1.04; 95% CI, 1.01-1.08).
• Overall, 1573 pregnancies filled prescriptions for 900 MMEs or greater, which was associated with at least a 21% increased risk for spontaneous preterm birth compared with no opioid exposure (aOR, 1.21; 95% CI, 1.10-1.33).
• Researchers found no significant difference in odds of spontaneous preterm birth among included opioid types after adjusting for confounders and opioid MMD.

IN PRACTICE:

“This association may appear modest, especially considering that common, one-time prescriptions often fall in the 150-225 MME range, but these findings may provide more caution when prescribing multiple, higher strength opioids,” the authors wrote. “We also caution against the conclusion that lower doses, especially those below 100 MME, are safe; the confidence bands over the low dose range still include odds ratios that are consistent with meaningful harm.”

SOURCE:

Sarah S. Osmundson, MD, MS, of the Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee, was the senior and corresponding author on the study. The study was published online on February 14 in JAMA Network Open.

LIMITATIONS:

Data are based on opioids prescribed and lack detail on actual use of opioids and nonprescription analgesics. Findings may not be generalizable to other populations or settings outside Medicaid.

DISCLOSURES:

No source of study funding listed. Dr. Osmundson reported receiving grant support from the National Institute on Drug Abuse during the conduct of the study. The other authors’ disclosures are listed on the original paper.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Doxorubicin increases the risk for breast cancer in women with Hodgkin lymphoma, suggesting the need for increased surveillance.

METHODOLOGY:

• Doxorubicin is a mainstay of Hodgkin lymphoma treatment.
• Studies suggest that girls with Hodgkin lymphoma who receive doxorubicin have a higher risk for breast cancer later in life, but it is unclear if women treated as adults face that same risk.
• To find out, investigators reviewed breast cancer incidence in 1964 Dutch women, ages 15-50, who were treated for Hodgkin lymphoma from 1975 to 2008.
• Patients had survived for at least 5 years, and 57% received doxorubicin.

TAKEAWAY:

• Women treated with doxorubicin had a 40% higher risk for breast cancer, and that risk was independent of age of treatment, receipt of chest radiation, and the use of gonadotoxic agents.
• The risk for breast cancer with doxorubicin was dose-dependent, with each 100 mg/m2 dose increment increasing the risk by 18%.
• The findings held whether women were treated years ago or more recently, despite the evolution of treatment strategies for Hodgkin lymphoma.
• After 30 years of follow-up, nearly one in five survivors (20.8%) developed breast cancer. It took 20 years for the elevated risk for breast cancer following treatment with doxorubicin to emerge.

IN PRACTICE:

The study suggests that adolescent and adult women survivors of Hodgkin lymphoma who received doxorubicin have an increased risk for breast cancer, and this risk is independent of age at first Hodgkin lymphoma treatment, receipt of chest radiotherapy, and gonadotoxic treatment, the authors concluded. “Our results have implications for [breast cancer] surveillance guidelines for [Hodgkin lymphoma] survivors and treatment strategies for patients with newly diagnosed” Hodgkin lymphoma.

SOURCE:

The study, led by Suzanne Neppelenbroek of the Netherlands Cancer Institute, Amsterdam, was published February 15 in the Journal of Clinical Oncology. 

LIMITATIONS:

Recruitment ended in 2008 before the advent of newer treatments such as antibody-drug conjugates and immune checkpoint inhibitors.

DISCLOSURES:

The work was funded by the Dutch Cancer Society. Several authors reported ties to Lilly, AbbVie, Amgen, and other companies.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Doxorubicin increases the risk for breast cancer in women with Hodgkin lymphoma, suggesting the need for increased surveillance.

METHODOLOGY:

• Doxorubicin is a mainstay of Hodgkin lymphoma treatment.
• Studies suggest that girls with Hodgkin lymphoma who receive doxorubicin have a higher risk for breast cancer later in life, but it is unclear if women treated as adults face that same risk.
• To find out, investigators reviewed breast cancer incidence in 1964 Dutch women, ages 15-50, who were treated for Hodgkin lymphoma from 1975 to 2008.
• Patients had survived for at least 5 years, and 57% received doxorubicin.

TAKEAWAY:

• Women treated with doxorubicin had a 40% higher risk for breast cancer, and that risk was independent of age of treatment, receipt of chest radiation, and the use of gonadotoxic agents.
• The risk for breast cancer with doxorubicin was dose-dependent, with each 100 mg/m2 dose increment increasing the risk by 18%.
• The findings held whether women were treated years ago or more recently, despite the evolution of treatment strategies for Hodgkin lymphoma.
• After 30 years of follow-up, nearly one in five survivors (20.8%) developed breast cancer. It took 20 years for the elevated risk for breast cancer following treatment with doxorubicin to emerge.

IN PRACTICE:

The study suggests that adolescent and adult women survivors of Hodgkin lymphoma who received doxorubicin have an increased risk for breast cancer, and this risk is independent of age at first Hodgkin lymphoma treatment, receipt of chest radiotherapy, and gonadotoxic treatment, the authors concluded. “Our results have implications for [breast cancer] surveillance guidelines for [Hodgkin lymphoma] survivors and treatment strategies for patients with newly diagnosed” Hodgkin lymphoma.

SOURCE:

The study, led by Suzanne Neppelenbroek of the Netherlands Cancer Institute, Amsterdam, was published February 15 in the Journal of Clinical Oncology. 

LIMITATIONS:

Recruitment ended in 2008 before the advent of newer treatments such as antibody-drug conjugates and immune checkpoint inhibitors.

DISCLOSURES:

The work was funded by the Dutch Cancer Society. Several authors reported ties to Lilly, AbbVie, Amgen, and other companies.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Doxorubicin increases the risk for breast cancer in women with Hodgkin lymphoma, suggesting the need for increased surveillance.

METHODOLOGY:

• Doxorubicin is a mainstay of Hodgkin lymphoma treatment.
• Studies suggest that girls with Hodgkin lymphoma who receive doxorubicin have a higher risk for breast cancer later in life, but it is unclear if women treated as adults face that same risk.
• To find out, investigators reviewed breast cancer incidence in 1964 Dutch women, ages 15-50, who were treated for Hodgkin lymphoma from 1975 to 2008.
• Patients had survived for at least 5 years, and 57% received doxorubicin.

TAKEAWAY:

• Women treated with doxorubicin had a 40% higher risk for breast cancer, and that risk was independent of age of treatment, receipt of chest radiation, and the use of gonadotoxic agents.
• The risk for breast cancer with doxorubicin was dose-dependent, with each 100 mg/m2 dose increment increasing the risk by 18%.
• The findings held whether women were treated years ago or more recently, despite the evolution of treatment strategies for Hodgkin lymphoma.
• After 30 years of follow-up, nearly one in five survivors (20.8%) developed breast cancer. It took 20 years for the elevated risk for breast cancer following treatment with doxorubicin to emerge.

IN PRACTICE:

The study suggests that adolescent and adult women survivors of Hodgkin lymphoma who received doxorubicin have an increased risk for breast cancer, and this risk is independent of age at first Hodgkin lymphoma treatment, receipt of chest radiotherapy, and gonadotoxic treatment, the authors concluded. “Our results have implications for [breast cancer] surveillance guidelines for [Hodgkin lymphoma] survivors and treatment strategies for patients with newly diagnosed” Hodgkin lymphoma.

SOURCE:

The study, led by Suzanne Neppelenbroek of the Netherlands Cancer Institute, Amsterdam, was published February 15 in the Journal of Clinical Oncology. 

LIMITATIONS:

Recruitment ended in 2008 before the advent of newer treatments such as antibody-drug conjugates and immune checkpoint inhibitors.

DISCLOSURES:

The work was funded by the Dutch Cancer Society. Several authors reported ties to Lilly, AbbVie, Amgen, and other companies.
 

A version of this article appeared on Medscape.com.

Calling the matter “a danger the public should not be forced to shoulder,” a federal judge has rejected a plea to temporarily restore the scores of 832 medical graduates from Nepal who are suspected of cheating on the United States Medical Licensing Exam (USMLE). 

In a February 23 order, Judge Christopher R. Cooper, of the US District Court for the District of Columbia, denied Latika Giri’s emergency motion to block the National Board of Medical Examiners (NBME) from invalidating the scores, ruling the public interest plainly weighs against granting the request. 

“First and foremost, is the overriding interest in public safety,” Cooper wrote in his 32-page order. “This is a case about the credentials of doctors applying to medical residency programs…Granting the preliminary injunction would create an unacceptable risk that individuals who lack the requisite knowledge and skills they purport to possess because they achieved their exam scores fraudulently will be administering medical care to unsuspecting patients across the nation.”

Attorneys for Giri did not return messages seeking comment about the order. 

The NBME also did not return messages seeking comment. The board previously said it does not comment on pending litigation. 

The decision is the latest development in a widespread cheating scandal. Giri, an international medical graduate (IMG) from Kathmandu, sued NBME earlier this month claiming the board discriminated against Nepali medical graduates when it invalidated hundreds of exam scores linked to the country. 

Giri also accused NBME of violating its own procedures when it voided the scores before giving examinees a chance to argue and appeal. She asked the district court to block NBME from invalidating her exam scores while the lawsuit continues and restore her original results. 

In court documents, NBME argued that it did not invalidate the scores because the examinees were Nepali but because staff concluded that there was “a good faith basis for questioning the validity of the scores.” 

The invalidations were based on concerns that the results reflected prior access to secure exam content rather than knowledge and understanding of the medical principles and skills the exams are intended to assess, according to the NBME’s legal response. 

“The USMLE program took reasonable and appropriate actions to prevent the significant harm and disruption that would result from allowing potentially unqualified individuals to participate in the 2024 residency Match,” the NBME stated in court documents. “If granted, the requested injunction would cause enormous harm not only to NBME… but also to state licensing authorities, which rely upon USMLE results to help ensure that physicians have the minimum competencies needed to provide safe and effective health care.”

In his order, Cooper wrote that Giri has not proven the board’s actions were discriminatory against Nepali doctors. 

“Nothing in the present record suggests that NBME went looking for a problem in Nepal out of ethnicity-or national-origin based [sic] suspicion,” Cooper wrote. “[It] followed the trail of evidence, including tips about organized cheating taking place in medical schools and at a testing center located in Nepal, and on an online forum for which a ‘nexus to Nepal’ was a ticket to admission.”

NBME: Nepal Outperformed All Other Countries on USMLE 

Court documents shed more light on NBME’s investigation into the suspected cheating and on the anomalous patterns the board allegedly discovered from Nepal medical graduates. 

In response to anonymous tips, the USMLE program in early 2023 asked the NBME Psychometrics and Data Analysis (PADA) unit to analyze examinee performance data for test centers in Jordan, Nepal, and Pakistan, according to court records. Within the initial data analysis, the data involving the single test center in Nepal was “the most extreme,” the unit found. 

Out of more than 400 test centers across the world, including those in the United States, the test center in Nepal produced the highest test scores in the world for Step 1 in 2021 and 2022 and the highest test scores in the world for Step 2 CK in 2022, according to court documents. For the 2022 Step 1 exam for example, the average score of examinees testing in the Nepal test center was 240. No other test center in the world had an average examinee score above 227, according to the NBME’s legal response. 

The median item response time for examinees who tested at the Nepal test center in 2022 was also among the fastest of all international test centers for Step 1 and Step 2 CK, investigators found. 

In addition, the volume of examinees taking the USMLE Step 1 and Step 2 CK at the Nepal test center in Nepal had sharply increased. Step 1 volume more than doubled in the Nepal test center from 281 examinees in 2019 to 662 examinees in 2022, according to court documents. 

The rapid increase continued in 2023, when examinee volume was nearly three-and-a-half times higher than the 2019 volume. The data were consistent with anonymous tips received by the USMLE program office, suggesting there may be wide-scale collection and sharing of live USMLE exam content within Nepal. 

Investigation Finds Similar Correct and Incorrect Answers 

Agreement similarity among the exams analyzed also raised red flags. Investigators ran an “agreement analysis” for all examinees who tested at centers in Jordan, Nepal, and Pakistan as well as two centers in India, according to court documents. 

For the 2022 Step 1 exam and the 2021 and 2022 Step 2 CK exam, the analysis showed a substantially higher percentage of examinees with a statistically significant level of agreement matches in the examine group that tested at centers in Jordan, Nepal, Pakistan, and India compared with the baseline group, according to legal records. 

The vast majority of examinees with a statistically significant number of matching incorrect answers tested at the Nepal test center, data showed. 

Further analysis found that examinee volumes increased considerably at the Nepal test center in the months prior to the USMLE program releasing new test items, “suggesting that candidates who had prior access to disclosed exam questions wanted to test before new questions came into the item pool.”

Investigators also identified posts on social medial and in online chat rooms suggesting groups were collecting and sharing large amounts of secure exam material in private groups. Some posts advised examinees to use the full examination time when taking the USMLE “to avoid raising suspicion about having had prior access to secure exam materials,” according to court documents. 

From its investigation and analysis, the USMLE program identified 832 examinees who had passing level exam results whose validity the USMLE program had a significant and good faith basis for questioning, according to court records. 

Of the total, 618 examinees had one Step score flagged as being of questioned validity, 202 examinees had two Step exam scores flagged, and 12 examinees had scores flagged on all three Step exams. 

NBME Defends Departure From Traditional Procedures

In court documents, NBME disputed claims that it violated its own procedures by invalidating the exam scores. Giri’s report contends that examinees suspected of cheating are typically first advised of the matter, given an opportunity to share relevant information, and provided the right to appeal — during which time, their scores are treated as valid. 

But the NBME said the USMLE program is authorized to take any actions it deems appropriate in response to concerns regarding score validity if the USMLE Committee for Individualized Review or the USMLE Composite Committee concludes that alternative or supplemental procedures are warranted in response to a given set of facts or circumstances. 

“Following the month-long investigation and analysis…the USMLE program concluded that alternative procedures were warranted to address the score invalidity concerns identified in the interest of providing a process that is timely, efficient, effective, and fair, and given the large number of examinees involved in the investigation,” the board stated in its legal response. 

In his order, Cooper wrote the current scenario, which implicates that more than 800 test-takers, is “clearly a situation calling for a procedure geared toward efficiency.” No evidence shows the board would not have taken similarly swift action if confronted with evidence of cheating on a comparable scale elsewhere, he wrote. 

The judge also denied Giri’s motion to certify the lawsuit as a class action. The motion was denied without prejudice, meaning the plaintiff has the option to renew the motion should the case proceed. 

A version of this article appeared on Medscape.com.

Calling the matter “a danger the public should not be forced to shoulder,” a federal judge has rejected a plea to temporarily restore the scores of 832 medical graduates from Nepal who are suspected of cheating on the United States Medical Licensing Exam (USMLE). 

In a February 23 order, Judge Christopher R. Cooper, of the US District Court for the District of Columbia, denied Latika Giri’s emergency motion to block the National Board of Medical Examiners (NBME) from invalidating the scores, ruling the public interest plainly weighs against granting the request. 

“First and foremost, is the overriding interest in public safety,” Cooper wrote in his 32-page order. “This is a case about the credentials of doctors applying to medical residency programs…Granting the preliminary injunction would create an unacceptable risk that individuals who lack the requisite knowledge and skills they purport to possess because they achieved their exam scores fraudulently will be administering medical care to unsuspecting patients across the nation.”

Attorneys for Giri did not return messages seeking comment about the order. 

The NBME also did not return messages seeking comment. The board previously said it does not comment on pending litigation. 

The decision is the latest development in a widespread cheating scandal. Giri, an international medical graduate (IMG) from Kathmandu, sued NBME earlier this month claiming the board discriminated against Nepali medical graduates when it invalidated hundreds of exam scores linked to the country. 

Giri also accused NBME of violating its own procedures when it voided the scores before giving examinees a chance to argue and appeal. She asked the district court to block NBME from invalidating her exam scores while the lawsuit continues and restore her original results. 

In court documents, NBME argued that it did not invalidate the scores because the examinees were Nepali but because staff concluded that there was “a good faith basis for questioning the validity of the scores.” 

The invalidations were based on concerns that the results reflected prior access to secure exam content rather than knowledge and understanding of the medical principles and skills the exams are intended to assess, according to the NBME’s legal response. 

“The USMLE program took reasonable and appropriate actions to prevent the significant harm and disruption that would result from allowing potentially unqualified individuals to participate in the 2024 residency Match,” the NBME stated in court documents. “If granted, the requested injunction would cause enormous harm not only to NBME… but also to state licensing authorities, which rely upon USMLE results to help ensure that physicians have the minimum competencies needed to provide safe and effective health care.”

In his order, Cooper wrote that Giri has not proven the board’s actions were discriminatory against Nepali doctors. 

“Nothing in the present record suggests that NBME went looking for a problem in Nepal out of ethnicity-or national-origin based [sic] suspicion,” Cooper wrote. “[It] followed the trail of evidence, including tips about organized cheating taking place in medical schools and at a testing center located in Nepal, and on an online forum for which a ‘nexus to Nepal’ was a ticket to admission.”

NBME: Nepal Outperformed All Other Countries on USMLE 

Court documents shed more light on NBME’s investigation into the suspected cheating and on the anomalous patterns the board allegedly discovered from Nepal medical graduates. 

In response to anonymous tips, the USMLE program in early 2023 asked the NBME Psychometrics and Data Analysis (PADA) unit to analyze examinee performance data for test centers in Jordan, Nepal, and Pakistan, according to court records. Within the initial data analysis, the data involving the single test center in Nepal was “the most extreme,” the unit found. 

Out of more than 400 test centers across the world, including those in the United States, the test center in Nepal produced the highest test scores in the world for Step 1 in 2021 and 2022 and the highest test scores in the world for Step 2 CK in 2022, according to court documents. For the 2022 Step 1 exam for example, the average score of examinees testing in the Nepal test center was 240. No other test center in the world had an average examinee score above 227, according to the NBME’s legal response. 

The median item response time for examinees who tested at the Nepal test center in 2022 was also among the fastest of all international test centers for Step 1 and Step 2 CK, investigators found. 

In addition, the volume of examinees taking the USMLE Step 1 and Step 2 CK at the Nepal test center in Nepal had sharply increased. Step 1 volume more than doubled in the Nepal test center from 281 examinees in 2019 to 662 examinees in 2022, according to court documents. 

The rapid increase continued in 2023, when examinee volume was nearly three-and-a-half times higher than the 2019 volume. The data were consistent with anonymous tips received by the USMLE program office, suggesting there may be wide-scale collection and sharing of live USMLE exam content within Nepal. 

Investigation Finds Similar Correct and Incorrect Answers 

Agreement similarity among the exams analyzed also raised red flags. Investigators ran an “agreement analysis” for all examinees who tested at centers in Jordan, Nepal, and Pakistan as well as two centers in India, according to court documents. 

For the 2022 Step 1 exam and the 2021 and 2022 Step 2 CK exam, the analysis showed a substantially higher percentage of examinees with a statistically significant level of agreement matches in the examine group that tested at centers in Jordan, Nepal, Pakistan, and India compared with the baseline group, according to legal records. 

The vast majority of examinees with a statistically significant number of matching incorrect answers tested at the Nepal test center, data showed. 

Further analysis found that examinee volumes increased considerably at the Nepal test center in the months prior to the USMLE program releasing new test items, “suggesting that candidates who had prior access to disclosed exam questions wanted to test before new questions came into the item pool.”

Investigators also identified posts on social medial and in online chat rooms suggesting groups were collecting and sharing large amounts of secure exam material in private groups. Some posts advised examinees to use the full examination time when taking the USMLE “to avoid raising suspicion about having had prior access to secure exam materials,” according to court documents. 

From its investigation and analysis, the USMLE program identified 832 examinees who had passing level exam results whose validity the USMLE program had a significant and good faith basis for questioning, according to court records. 

Of the total, 618 examinees had one Step score flagged as being of questioned validity, 202 examinees had two Step exam scores flagged, and 12 examinees had scores flagged on all three Step exams. 

NBME Defends Departure From Traditional Procedures

In court documents, NBME disputed claims that it violated its own procedures by invalidating the exam scores. Giri’s report contends that examinees suspected of cheating are typically first advised of the matter, given an opportunity to share relevant information, and provided the right to appeal — during which time, their scores are treated as valid. 

But the NBME said the USMLE program is authorized to take any actions it deems appropriate in response to concerns regarding score validity if the USMLE Committee for Individualized Review or the USMLE Composite Committee concludes that alternative or supplemental procedures are warranted in response to a given set of facts or circumstances. 

“Following the month-long investigation and analysis…the USMLE program concluded that alternative procedures were warranted to address the score invalidity concerns identified in the interest of providing a process that is timely, efficient, effective, and fair, and given the large number of examinees involved in the investigation,” the board stated in its legal response. 

In his order, Cooper wrote the current scenario, which implicates that more than 800 test-takers, is “clearly a situation calling for a procedure geared toward efficiency.” No evidence shows the board would not have taken similarly swift action if confronted with evidence of cheating on a comparable scale elsewhere, he wrote. 

The judge also denied Giri’s motion to certify the lawsuit as a class action. The motion was denied without prejudice, meaning the plaintiff has the option to renew the motion should the case proceed. 

A version of this article appeared on Medscape.com.

Calling the matter “a danger the public should not be forced to shoulder,” a federal judge has rejected a plea to temporarily restore the scores of 832 medical graduates from Nepal who are suspected of cheating on the United States Medical Licensing Exam (USMLE). 

In a February 23 order, Judge Christopher R. Cooper, of the US District Court for the District of Columbia, denied Latika Giri’s emergency motion to block the National Board of Medical Examiners (NBME) from invalidating the scores, ruling the public interest plainly weighs against granting the request. 

“First and foremost, is the overriding interest in public safety,” Cooper wrote in his 32-page order. “This is a case about the credentials of doctors applying to medical residency programs…Granting the preliminary injunction would create an unacceptable risk that individuals who lack the requisite knowledge and skills they purport to possess because they achieved their exam scores fraudulently will be administering medical care to unsuspecting patients across the nation.”

Attorneys for Giri did not return messages seeking comment about the order. 

The NBME also did not return messages seeking comment. The board previously said it does not comment on pending litigation. 

The decision is the latest development in a widespread cheating scandal. Giri, an international medical graduate (IMG) from Kathmandu, sued NBME earlier this month claiming the board discriminated against Nepali medical graduates when it invalidated hundreds of exam scores linked to the country. 

Giri also accused NBME of violating its own procedures when it voided the scores before giving examinees a chance to argue and appeal. She asked the district court to block NBME from invalidating her exam scores while the lawsuit continues and restore her original results. 

In court documents, NBME argued that it did not invalidate the scores because the examinees were Nepali but because staff concluded that there was “a good faith basis for questioning the validity of the scores.” 

The invalidations were based on concerns that the results reflected prior access to secure exam content rather than knowledge and understanding of the medical principles and skills the exams are intended to assess, according to the NBME’s legal response. 

“The USMLE program took reasonable and appropriate actions to prevent the significant harm and disruption that would result from allowing potentially unqualified individuals to participate in the 2024 residency Match,” the NBME stated in court documents. “If granted, the requested injunction would cause enormous harm not only to NBME… but also to state licensing authorities, which rely upon USMLE results to help ensure that physicians have the minimum competencies needed to provide safe and effective health care.”

In his order, Cooper wrote that Giri has not proven the board’s actions were discriminatory against Nepali doctors. 

“Nothing in the present record suggests that NBME went looking for a problem in Nepal out of ethnicity-or national-origin based [sic] suspicion,” Cooper wrote. “[It] followed the trail of evidence, including tips about organized cheating taking place in medical schools and at a testing center located in Nepal, and on an online forum for which a ‘nexus to Nepal’ was a ticket to admission.”

NBME: Nepal Outperformed All Other Countries on USMLE 

Court documents shed more light on NBME’s investigation into the suspected cheating and on the anomalous patterns the board allegedly discovered from Nepal medical graduates. 

In response to anonymous tips, the USMLE program in early 2023 asked the NBME Psychometrics and Data Analysis (PADA) unit to analyze examinee performance data for test centers in Jordan, Nepal, and Pakistan, according to court records. Within the initial data analysis, the data involving the single test center in Nepal was “the most extreme,” the unit found. 

Out of more than 400 test centers across the world, including those in the United States, the test center in Nepal produced the highest test scores in the world for Step 1 in 2021 and 2022 and the highest test scores in the world for Step 2 CK in 2022, according to court documents. For the 2022 Step 1 exam for example, the average score of examinees testing in the Nepal test center was 240. No other test center in the world had an average examinee score above 227, according to the NBME’s legal response. 

The median item response time for examinees who tested at the Nepal test center in 2022 was also among the fastest of all international test centers for Step 1 and Step 2 CK, investigators found. 

In addition, the volume of examinees taking the USMLE Step 1 and Step 2 CK at the Nepal test center in Nepal had sharply increased. Step 1 volume more than doubled in the Nepal test center from 281 examinees in 2019 to 662 examinees in 2022, according to court documents. 

The rapid increase continued in 2023, when examinee volume was nearly three-and-a-half times higher than the 2019 volume. The data were consistent with anonymous tips received by the USMLE program office, suggesting there may be wide-scale collection and sharing of live USMLE exam content within Nepal. 

Investigation Finds Similar Correct and Incorrect Answers 

Agreement similarity among the exams analyzed also raised red flags. Investigators ran an “agreement analysis” for all examinees who tested at centers in Jordan, Nepal, and Pakistan as well as two centers in India, according to court documents. 

For the 2022 Step 1 exam and the 2021 and 2022 Step 2 CK exam, the analysis showed a substantially higher percentage of examinees with a statistically significant level of agreement matches in the examine group that tested at centers in Jordan, Nepal, Pakistan, and India compared with the baseline group, according to legal records. 

The vast majority of examinees with a statistically significant number of matching incorrect answers tested at the Nepal test center, data showed. 

Further analysis found that examinee volumes increased considerably at the Nepal test center in the months prior to the USMLE program releasing new test items, “suggesting that candidates who had prior access to disclosed exam questions wanted to test before new questions came into the item pool.”

Investigators also identified posts on social medial and in online chat rooms suggesting groups were collecting and sharing large amounts of secure exam material in private groups. Some posts advised examinees to use the full examination time when taking the USMLE “to avoid raising suspicion about having had prior access to secure exam materials,” according to court documents. 

From its investigation and analysis, the USMLE program identified 832 examinees who had passing level exam results whose validity the USMLE program had a significant and good faith basis for questioning, according to court records. 

Of the total, 618 examinees had one Step score flagged as being of questioned validity, 202 examinees had two Step exam scores flagged, and 12 examinees had scores flagged on all three Step exams. 

NBME Defends Departure From Traditional Procedures

In court documents, NBME disputed claims that it violated its own procedures by invalidating the exam scores. Giri’s report contends that examinees suspected of cheating are typically first advised of the matter, given an opportunity to share relevant information, and provided the right to appeal — during which time, their scores are treated as valid. 

But the NBME said the USMLE program is authorized to take any actions it deems appropriate in response to concerns regarding score validity if the USMLE Committee for Individualized Review or the USMLE Composite Committee concludes that alternative or supplemental procedures are warranted in response to a given set of facts or circumstances. 

“Following the month-long investigation and analysis…the USMLE program concluded that alternative procedures were warranted to address the score invalidity concerns identified in the interest of providing a process that is timely, efficient, effective, and fair, and given the large number of examinees involved in the investigation,” the board stated in its legal response. 

In his order, Cooper wrote the current scenario, which implicates that more than 800 test-takers, is “clearly a situation calling for a procedure geared toward efficiency.” No evidence shows the board would not have taken similarly swift action if confronted with evidence of cheating on a comparable scale elsewhere, he wrote. 

The judge also denied Giri’s motion to certify the lawsuit as a class action. The motion was denied without prejudice, meaning the plaintiff has the option to renew the motion should the case proceed. 

A version of this article appeared on Medscape.com.