Alicia Ault

A new consensus statement recommended genetic testing for all categories of kidney diseases whenever a genetic cause is suspected and offered guidance on who to test, which tests are the most useful, and how to talk to patients about results.

The statement, published online in the American Journal of Kidney Diseases, is the work of four dozen authors — including patients, nephrologists, experts in clinical and laboratory genetics, kidney pathology, genetic counseling, and ethics. The experts were brought together by the National Kidney Foundation (NKF) with the goal of broadening use and understanding of the tests.

About 10% or more of kidney diseases in adults and 70% of selected chronic kidney diseases (CKDs) in children have genetic causes. But nephrologists have reported a lack of education about genetic testing, and other barriers to wider use, including limited access to testing, cost, insurance coverage, and a small number of genetic counselors who are versed in kidney genetics.

Genetic testing “in the kidney field is a little less developed than in other fields,” said co–lead author Nora Franceschini, MD, MPH, a professor of epidemiology at the University of North Carolina Gillings School of Global Public Health, Chapel Hill, and a nephrologist who studies the genetic epidemiology of hypertension and kidney and cardiovascular diseases.

There are already many known variants that play a role in various kidney diseases and more are on the horizon, Dr. Franceschini told this news organization. More genetic tests will be available in the near future. “The workforce needs to be prepared,” she said.

The statement is an initial step that gets clinicians thinking about testing in a more systematic way, said Dr. Franceschini. “Genetic testing is just another test that physicians can use to complete the story when evaluating patients.

“I think clinicians are ready to implement” testing, said Dr. Franceschini. “We just need to have better guidance.”
 

Who, When, What to Test

The NKF statement is not the first to try to address gaps in use and knowledge. A European Renal Association Working Group published guidelines in 2022.

The NKF Working Group came up with 56 recommendations and separate algorithms to guide testing for adult and pediatric individuals who are considered at-risk (and currently asymptomatic) and for those who already have clinical disease.

Testing can help determine a cause if there’s an atypical clinical presentation, and it can help avoid biopsies, said the group. Tests can also guide choice of therapy.

For at-risk individuals, there are two broad situations in which testing might be considered: In family members of a patient who already has kidney disease and in potential kidney donors. But testing at-risk children younger than 18 years should only be done if there is an intervention available that could prevent, treat, or slow progression of disease, said the authors.

For patients with an established genetic diagnosis, at-risk family members should be tested with the known single-gene variant diagnostic instead of a broad panel, said the group.

Single-gene variant testing is most appropriate in situations when clinical disease is already evident or when there is known genetic disease in the family, according to the NKF panel. A large diagnostic panel that covers the many common genetic causes of kidney disease is recommended for the majority of patients.

The group recommended that apolipoprotein L1 (APOL1) testing should be included in gene panels for CKD, and it should be offered to any patient “with clinical findings suggestive of APOL1-association nephropathy, regardless of race and ethnicity.”

High-risk APOL1 genotypes confer a 5- to 10-fold increased risk for CKD and are found in one out of seven individuals of African ancestry, which means the focus has largely been on testing those with that ancestry.

However, with many unknowns about APOL1, the NKF panel did not want to “profile” individuals and suggest that testing should not be based on skin color or race/ethnicity, said Dr. Franceschini.

In addition, only about 10% of those with the variant develop disease, so testing is not currently warranted for those who do not already have kidney disease, said the group.

They also recommended against the use of polygenic risk scores, saying that there are not enough data from diverse populations in genome-wide association studies for kidney disease or on their clinical utility.
 

More Education Needed; Many Barriers

The authors acknowledged that nephrologists generally receive little education in genetics and lack support for interpreting and discussing results.

“Nephrologists should be provided with training and best practice resources to interpret genetic testing and discuss the results with individuals and their families,” they wrote, adding that there’s a need for genomic medicine boards at academic centers that would be available to help nephrologists interpret results and plot clinical management.

The group did not, however, cite some of the other barriers to adoption of testing, including a limited number of sites offering testing, cost, and lack of insurance coverage for the diagnostics.

Medicare may cover genetic testing for kidney disease when an individual has symptoms and there is a Food and Drug Administration–approved test. Joseph Vassalotti, MD, chief medical officer for the NKF, said private insurance may cover the testing if the nephrologist deems it medically necessary, but that he usually confirms coverage before initiating testing. The often-used Renasight panel, which tests for 385 genes related to kidney diseases, costs $300-$400 out of pocket, Dr. Vassalotti told this news organization.

In a survey of 149 nephrologists conducted in 2021, both users (46%) and nonusers of the tests (69%) said that high cost was the most significant perceived barrier to implementing widespread testing. A third of users and almost two thirds of nonusers said that poor availability or lack of ease of testing was the second most significant barrier.

Clinics that test for kidney genes “are largely confined to large academic centers and some specialty clinics,” said Dominic Raj, MD, the Bert B. Brooks chair, and Divya Shankaranarayanan, MD, director of the Kidney Precision Medicine Clinic, both at George Washington University School of Medicine & Health Sciences, Washington, DC, in an email.

Testing is also limited by cultural barriers, lack of genetic literacy, and patients’ concerns that a positive result could lead to a loss of health insurance coverage, said Dr. Raj and Dr. Shankaranarayanan.
 

Paper Will Help Expand Use

A lack of consensus has also held back expansion. The new statement “may lead to increased and possibly judicious utilization of genetic testing in nephrology practices,” said Dr. Raj and Dr. Shankaranarayanan. “Most importantly, the panel has given specific guidance as to what type of genetic test platform is likely to yield the best and most cost-effective yield.”

The most effective use is “in monogenic kidney diseases and to a lesser extent in oligogenic kidney disease,” said Dr. Raj and Dr. Shankaranarayanan, adding that testing is of less-certain utility in polygenic kidney diseases, “where complex genetic and epigenetic factors determine the phenotype.”

Genetic testing might be especially useful “in atypical clinical presentations” and can help clinicians avoid unnecessary expensive and extensive investigations when multiple organ systems are involved, they said.

“Most importantly, [testing] might prevent unnecessary and potentially harmful treatment and enable targeted specific treatment, when available,” said Dr. Raj and Dr. Shankaranarayanan.

Dr. Franceschini and Dr. Shankaranarayanan reported no relevant financial relationships. Dr. Raj disclosed that he received consulting fees and honoraria from Novo Nordisk and is a national leader for the company’s Zeus trial, studying whether ziltivekimab reduces the risk for cardiovascular events in cardiovascular disease, CKD, and inflammation. He also participated in a study of Natera’s Renasight, a 385-gene panel for kidney disease.

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

A new consensus statement recommended genetic testing for all categories of kidney diseases whenever a genetic cause is suspected and offered guidance on who to test, which tests are the most useful, and how to talk to patients about results.

The statement, published online in the American Journal of Kidney Diseases, is the work of four dozen authors — including patients, nephrologists, experts in clinical and laboratory genetics, kidney pathology, genetic counseling, and ethics. The experts were brought together by the National Kidney Foundation (NKF) with the goal of broadening use and understanding of the tests.

About 10% or more of kidney diseases in adults and 70% of selected chronic kidney diseases (CKDs) in children have genetic causes. But nephrologists have reported a lack of education about genetic testing, and other barriers to wider use, including limited access to testing, cost, insurance coverage, and a small number of genetic counselors who are versed in kidney genetics.

Genetic testing “in the kidney field is a little less developed than in other fields,” said co–lead author Nora Franceschini, MD, MPH, a professor of epidemiology at the University of North Carolina Gillings School of Global Public Health, Chapel Hill, and a nephrologist who studies the genetic epidemiology of hypertension and kidney and cardiovascular diseases.

There are already many known variants that play a role in various kidney diseases and more are on the horizon, Dr. Franceschini told this news organization. More genetic tests will be available in the near future. “The workforce needs to be prepared,” she said.

The statement is an initial step that gets clinicians thinking about testing in a more systematic way, said Dr. Franceschini. “Genetic testing is just another test that physicians can use to complete the story when evaluating patients.

“I think clinicians are ready to implement” testing, said Dr. Franceschini. “We just need to have better guidance.”
 

Who, When, What to Test

The NKF statement is not the first to try to address gaps in use and knowledge. A European Renal Association Working Group published guidelines in 2022.

The NKF Working Group came up with 56 recommendations and separate algorithms to guide testing for adult and pediatric individuals who are considered at-risk (and currently asymptomatic) and for those who already have clinical disease.

Testing can help determine a cause if there’s an atypical clinical presentation, and it can help avoid biopsies, said the group. Tests can also guide choice of therapy.

For at-risk individuals, there are two broad situations in which testing might be considered: In family members of a patient who already has kidney disease and in potential kidney donors. But testing at-risk children younger than 18 years should only be done if there is an intervention available that could prevent, treat, or slow progression of disease, said the authors.

For patients with an established genetic diagnosis, at-risk family members should be tested with the known single-gene variant diagnostic instead of a broad panel, said the group.

Single-gene variant testing is most appropriate in situations when clinical disease is already evident or when there is known genetic disease in the family, according to the NKF panel. A large diagnostic panel that covers the many common genetic causes of kidney disease is recommended for the majority of patients.

The group recommended that apolipoprotein L1 (APOL1) testing should be included in gene panels for CKD, and it should be offered to any patient “with clinical findings suggestive of APOL1-association nephropathy, regardless of race and ethnicity.”

High-risk APOL1 genotypes confer a 5- to 10-fold increased risk for CKD and are found in one out of seven individuals of African ancestry, which means the focus has largely been on testing those with that ancestry.

However, with many unknowns about APOL1, the NKF panel did not want to “profile” individuals and suggest that testing should not be based on skin color or race/ethnicity, said Dr. Franceschini.

In addition, only about 10% of those with the variant develop disease, so testing is not currently warranted for those who do not already have kidney disease, said the group.

They also recommended against the use of polygenic risk scores, saying that there are not enough data from diverse populations in genome-wide association studies for kidney disease or on their clinical utility.
 

More Education Needed; Many Barriers

The authors acknowledged that nephrologists generally receive little education in genetics and lack support for interpreting and discussing results.

“Nephrologists should be provided with training and best practice resources to interpret genetic testing and discuss the results with individuals and their families,” they wrote, adding that there’s a need for genomic medicine boards at academic centers that would be available to help nephrologists interpret results and plot clinical management.

The group did not, however, cite some of the other barriers to adoption of testing, including a limited number of sites offering testing, cost, and lack of insurance coverage for the diagnostics.

Medicare may cover genetic testing for kidney disease when an individual has symptoms and there is a Food and Drug Administration–approved test. Joseph Vassalotti, MD, chief medical officer for the NKF, said private insurance may cover the testing if the nephrologist deems it medically necessary, but that he usually confirms coverage before initiating testing. The often-used Renasight panel, which tests for 385 genes related to kidney diseases, costs $300-$400 out of pocket, Dr. Vassalotti told this news organization.

In a survey of 149 nephrologists conducted in 2021, both users (46%) and nonusers of the tests (69%) said that high cost was the most significant perceived barrier to implementing widespread testing. A third of users and almost two thirds of nonusers said that poor availability or lack of ease of testing was the second most significant barrier.

Clinics that test for kidney genes “are largely confined to large academic centers and some specialty clinics,” said Dominic Raj, MD, the Bert B. Brooks chair, and Divya Shankaranarayanan, MD, director of the Kidney Precision Medicine Clinic, both at George Washington University School of Medicine & Health Sciences, Washington, DC, in an email.

Testing is also limited by cultural barriers, lack of genetic literacy, and patients’ concerns that a positive result could lead to a loss of health insurance coverage, said Dr. Raj and Dr. Shankaranarayanan.
 

Paper Will Help Expand Use

A lack of consensus has also held back expansion. The new statement “may lead to increased and possibly judicious utilization of genetic testing in nephrology practices,” said Dr. Raj and Dr. Shankaranarayanan. “Most importantly, the panel has given specific guidance as to what type of genetic test platform is likely to yield the best and most cost-effective yield.”

The most effective use is “in monogenic kidney diseases and to a lesser extent in oligogenic kidney disease,” said Dr. Raj and Dr. Shankaranarayanan, adding that testing is of less-certain utility in polygenic kidney diseases, “where complex genetic and epigenetic factors determine the phenotype.”

Genetic testing might be especially useful “in atypical clinical presentations” and can help clinicians avoid unnecessary expensive and extensive investigations when multiple organ systems are involved, they said.

“Most importantly, [testing] might prevent unnecessary and potentially harmful treatment and enable targeted specific treatment, when available,” said Dr. Raj and Dr. Shankaranarayanan.

Dr. Franceschini and Dr. Shankaranarayanan reported no relevant financial relationships. Dr. Raj disclosed that he received consulting fees and honoraria from Novo Nordisk and is a national leader for the company’s Zeus trial, studying whether ziltivekimab reduces the risk for cardiovascular events in cardiovascular disease, CKD, and inflammation. He also participated in a study of Natera’s Renasight, a 385-gene panel for kidney disease.

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

A new consensus statement recommended genetic testing for all categories of kidney diseases whenever a genetic cause is suspected and offered guidance on who to test, which tests are the most useful, and how to talk to patients about results.

The statement, published online in the American Journal of Kidney Diseases, is the work of four dozen authors — including patients, nephrologists, experts in clinical and laboratory genetics, kidney pathology, genetic counseling, and ethics. The experts were brought together by the National Kidney Foundation (NKF) with the goal of broadening use and understanding of the tests.

About 10% or more of kidney diseases in adults and 70% of selected chronic kidney diseases (CKDs) in children have genetic causes. But nephrologists have reported a lack of education about genetic testing, and other barriers to wider use, including limited access to testing, cost, insurance coverage, and a small number of genetic counselors who are versed in kidney genetics.

Genetic testing “in the kidney field is a little less developed than in other fields,” said co–lead author Nora Franceschini, MD, MPH, a professor of epidemiology at the University of North Carolina Gillings School of Global Public Health, Chapel Hill, and a nephrologist who studies the genetic epidemiology of hypertension and kidney and cardiovascular diseases.

There are already many known variants that play a role in various kidney diseases and more are on the horizon, Dr. Franceschini told this news organization. More genetic tests will be available in the near future. “The workforce needs to be prepared,” she said.

The statement is an initial step that gets clinicians thinking about testing in a more systematic way, said Dr. Franceschini. “Genetic testing is just another test that physicians can use to complete the story when evaluating patients.

“I think clinicians are ready to implement” testing, said Dr. Franceschini. “We just need to have better guidance.”
 

Who, When, What to Test

The NKF statement is not the first to try to address gaps in use and knowledge. A European Renal Association Working Group published guidelines in 2022.

The NKF Working Group came up with 56 recommendations and separate algorithms to guide testing for adult and pediatric individuals who are considered at-risk (and currently asymptomatic) and for those who already have clinical disease.

Testing can help determine a cause if there’s an atypical clinical presentation, and it can help avoid biopsies, said the group. Tests can also guide choice of therapy.

For at-risk individuals, there are two broad situations in which testing might be considered: In family members of a patient who already has kidney disease and in potential kidney donors. But testing at-risk children younger than 18 years should only be done if there is an intervention available that could prevent, treat, or slow progression of disease, said the authors.

For patients with an established genetic diagnosis, at-risk family members should be tested with the known single-gene variant diagnostic instead of a broad panel, said the group.

Single-gene variant testing is most appropriate in situations when clinical disease is already evident or when there is known genetic disease in the family, according to the NKF panel. A large diagnostic panel that covers the many common genetic causes of kidney disease is recommended for the majority of patients.

The group recommended that apolipoprotein L1 (APOL1) testing should be included in gene panels for CKD, and it should be offered to any patient “with clinical findings suggestive of APOL1-association nephropathy, regardless of race and ethnicity.”

High-risk APOL1 genotypes confer a 5- to 10-fold increased risk for CKD and are found in one out of seven individuals of African ancestry, which means the focus has largely been on testing those with that ancestry.

However, with many unknowns about APOL1, the NKF panel did not want to “profile” individuals and suggest that testing should not be based on skin color or race/ethnicity, said Dr. Franceschini.

In addition, only about 10% of those with the variant develop disease, so testing is not currently warranted for those who do not already have kidney disease, said the group.

They also recommended against the use of polygenic risk scores, saying that there are not enough data from diverse populations in genome-wide association studies for kidney disease or on their clinical utility.
 

More Education Needed; Many Barriers

The authors acknowledged that nephrologists generally receive little education in genetics and lack support for interpreting and discussing results.

“Nephrologists should be provided with training and best practice resources to interpret genetic testing and discuss the results with individuals and their families,” they wrote, adding that there’s a need for genomic medicine boards at academic centers that would be available to help nephrologists interpret results and plot clinical management.

The group did not, however, cite some of the other barriers to adoption of testing, including a limited number of sites offering testing, cost, and lack of insurance coverage for the diagnostics.

Medicare may cover genetic testing for kidney disease when an individual has symptoms and there is a Food and Drug Administration–approved test. Joseph Vassalotti, MD, chief medical officer for the NKF, said private insurance may cover the testing if the nephrologist deems it medically necessary, but that he usually confirms coverage before initiating testing. The often-used Renasight panel, which tests for 385 genes related to kidney diseases, costs $300-$400 out of pocket, Dr. Vassalotti told this news organization.

In a survey of 149 nephrologists conducted in 2021, both users (46%) and nonusers of the tests (69%) said that high cost was the most significant perceived barrier to implementing widespread testing. A third of users and almost two thirds of nonusers said that poor availability or lack of ease of testing was the second most significant barrier.

Clinics that test for kidney genes “are largely confined to large academic centers and some specialty clinics,” said Dominic Raj, MD, the Bert B. Brooks chair, and Divya Shankaranarayanan, MD, director of the Kidney Precision Medicine Clinic, both at George Washington University School of Medicine & Health Sciences, Washington, DC, in an email.

Testing is also limited by cultural barriers, lack of genetic literacy, and patients’ concerns that a positive result could lead to a loss of health insurance coverage, said Dr. Raj and Dr. Shankaranarayanan.
 

Paper Will Help Expand Use

A lack of consensus has also held back expansion. The new statement “may lead to increased and possibly judicious utilization of genetic testing in nephrology practices,” said Dr. Raj and Dr. Shankaranarayanan. “Most importantly, the panel has given specific guidance as to what type of genetic test platform is likely to yield the best and most cost-effective yield.”

The most effective use is “in monogenic kidney diseases and to a lesser extent in oligogenic kidney disease,” said Dr. Raj and Dr. Shankaranarayanan, adding that testing is of less-certain utility in polygenic kidney diseases, “where complex genetic and epigenetic factors determine the phenotype.”

Genetic testing might be especially useful “in atypical clinical presentations” and can help clinicians avoid unnecessary expensive and extensive investigations when multiple organ systems are involved, they said.

“Most importantly, [testing] might prevent unnecessary and potentially harmful treatment and enable targeted specific treatment, when available,” said Dr. Raj and Dr. Shankaranarayanan.

Dr. Franceschini and Dr. Shankaranarayanan reported no relevant financial relationships. Dr. Raj disclosed that he received consulting fees and honoraria from Novo Nordisk and is a national leader for the company’s Zeus trial, studying whether ziltivekimab reduces the risk for cardiovascular events in cardiovascular disease, CKD, and inflammation. He also participated in a study of Natera’s Renasight, a 385-gene panel for kidney disease.

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

Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.

A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.

As previously reported by this news organization, in late 2022, the US Food and Drug Administration (FDA) issued a communication alerting clinicians about the special management required for opioid overdoses tainted with xylazine, which is also known as “tranq” or “tranq dope.”

Subsequently, in early 2023, The White House Office of National Drug Control Policy designated xylazine combined with fentanyl as an emerging threat to the United States.

Both the FDA and the Drug Enforcement Administration have taken steps to try to stop trafficking of the combination. However, despite these efforts, xylazine use has continued to spread.

The Millennium Health Signals report showed that the greatest increase in xylazine use was largely in the western United States. In the first 6 months of 2023, 3% of urine drug tests (UDTs) in Washington, Oregon, California, Hawaii, and Alaska were positive for xylazine. From November 2023 to April 2024, this rose to 8%, a 147% increase. In the Mountain West, xylazine-positive UDTs increased from 2% in 2023 to 4% in 2024, an increase of 94%. In addition to growth in the West, the report showed that xylazine use increased by more than 100% in New England — from 14% in 2023 to 28% in 2024.

Nationally, 16% of all urine specimens were positive for xylazine from late 2023 to April 2024, up slightly from 14% from April to October 2023.

Xylazine use was highest in the East and in the mid-Atlantic United States. Still, positivity rates in the mid-Atlantic dropped from 44% to 33%. The states included in that group were New York, Pennsylvania, Delaware, and New Jersey. East North Central states (Ohio, Michigan, Wisconsin, Indiana, and Illinois) also experienced a decline in positive tests from 32% to 30%.

The South Atlantic states, which include Maryland, Virginia, West Virginia, North and South Carolina, Georgia, and Florida, had a 17% increase in positivity — from 22% to 26%.

From April 2023 to April 2024 state-level UDT positivity rates were 40% in Pennsylvania, 37% in New York, and 35% in Ohio. But rates vary by locality. In Clermont and Hamilton counties in Ohio — both in the Cincinnati area — about 70% of specimens were positive for xylazine.

About one third of specimens in Maryland and South Carolina contained xylazine.

“Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” Millennium Health Chief Clinical Officer Angela Huskey, PharmD, said in a press release.

The Health Signals Alert analyzed more than 50,000 fentanyl-positive UDT specimens collected between April 12, 2023, and April 11, 2024. Millennium Health researchers analyzed xylazine positivity rates in fentanyl-positive UDT specimens by the US Census Division and state.

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

Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.

A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.

As previously reported by this news organization, in late 2022, the US Food and Drug Administration (FDA) issued a communication alerting clinicians about the special management required for opioid overdoses tainted with xylazine, which is also known as “tranq” or “tranq dope.”

Subsequently, in early 2023, The White House Office of National Drug Control Policy designated xylazine combined with fentanyl as an emerging threat to the United States.

Both the FDA and the Drug Enforcement Administration have taken steps to try to stop trafficking of the combination. However, despite these efforts, xylazine use has continued to spread.

The Millennium Health Signals report showed that the greatest increase in xylazine use was largely in the western United States. In the first 6 months of 2023, 3% of urine drug tests (UDTs) in Washington, Oregon, California, Hawaii, and Alaska were positive for xylazine. From November 2023 to April 2024, this rose to 8%, a 147% increase. In the Mountain West, xylazine-positive UDTs increased from 2% in 2023 to 4% in 2024, an increase of 94%. In addition to growth in the West, the report showed that xylazine use increased by more than 100% in New England — from 14% in 2023 to 28% in 2024.

Nationally, 16% of all urine specimens were positive for xylazine from late 2023 to April 2024, up slightly from 14% from April to October 2023.

Xylazine use was highest in the East and in the mid-Atlantic United States. Still, positivity rates in the mid-Atlantic dropped from 44% to 33%. The states included in that group were New York, Pennsylvania, Delaware, and New Jersey. East North Central states (Ohio, Michigan, Wisconsin, Indiana, and Illinois) also experienced a decline in positive tests from 32% to 30%.

The South Atlantic states, which include Maryland, Virginia, West Virginia, North and South Carolina, Georgia, and Florida, had a 17% increase in positivity — from 22% to 26%.

From April 2023 to April 2024 state-level UDT positivity rates were 40% in Pennsylvania, 37% in New York, and 35% in Ohio. But rates vary by locality. In Clermont and Hamilton counties in Ohio — both in the Cincinnati area — about 70% of specimens were positive for xylazine.

About one third of specimens in Maryland and South Carolina contained xylazine.

“Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” Millennium Health Chief Clinical Officer Angela Huskey, PharmD, said in a press release.

The Health Signals Alert analyzed more than 50,000 fentanyl-positive UDT specimens collected between April 12, 2023, and April 11, 2024. Millennium Health researchers analyzed xylazine positivity rates in fentanyl-positive UDT specimens by the US Census Division and state.

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

Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.

A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.

As previously reported by this news organization, in late 2022, the US Food and Drug Administration (FDA) issued a communication alerting clinicians about the special management required for opioid overdoses tainted with xylazine, which is also known as “tranq” or “tranq dope.”

Subsequently, in early 2023, The White House Office of National Drug Control Policy designated xylazine combined with fentanyl as an emerging threat to the United States.

Both the FDA and the Drug Enforcement Administration have taken steps to try to stop trafficking of the combination. However, despite these efforts, xylazine use has continued to spread.

The Millennium Health Signals report showed that the greatest increase in xylazine use was largely in the western United States. In the first 6 months of 2023, 3% of urine drug tests (UDTs) in Washington, Oregon, California, Hawaii, and Alaska were positive for xylazine. From November 2023 to April 2024, this rose to 8%, a 147% increase. In the Mountain West, xylazine-positive UDTs increased from 2% in 2023 to 4% in 2024, an increase of 94%. In addition to growth in the West, the report showed that xylazine use increased by more than 100% in New England — from 14% in 2023 to 28% in 2024.

Nationally, 16% of all urine specimens were positive for xylazine from late 2023 to April 2024, up slightly from 14% from April to October 2023.

Xylazine use was highest in the East and in the mid-Atlantic United States. Still, positivity rates in the mid-Atlantic dropped from 44% to 33%. The states included in that group were New York, Pennsylvania, Delaware, and New Jersey. East North Central states (Ohio, Michigan, Wisconsin, Indiana, and Illinois) also experienced a decline in positive tests from 32% to 30%.

The South Atlantic states, which include Maryland, Virginia, West Virginia, North and South Carolina, Georgia, and Florida, had a 17% increase in positivity — from 22% to 26%.

From April 2023 to April 2024 state-level UDT positivity rates were 40% in Pennsylvania, 37% in New York, and 35% in Ohio. But rates vary by locality. In Clermont and Hamilton counties in Ohio — both in the Cincinnati area — about 70% of specimens were positive for xylazine.

About one third of specimens in Maryland and South Carolina contained xylazine.

“Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” Millennium Health Chief Clinical Officer Angela Huskey, PharmD, said in a press release.

The Health Signals Alert analyzed more than 50,000 fentanyl-positive UDT specimens collected between April 12, 2023, and April 11, 2024. Millennium Health researchers analyzed xylazine positivity rates in fentanyl-positive UDT specimens by the US Census Division and state.

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

Experts say the US Supreme Court’s ruling Friday to overturn the decades-old “Chevron doctrine” could severely restrict the ability of federal agencies to regulate all aspects of healthcare.

Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, wrote on X, “my worry is that it will paralyze policymaking in healthcare and other areas,” because “Congress will try to fill in more details, making it harder to pass legislation.” He also wrote that federal agencies “will become very cautious in using their regulatory authority.”

In their 6-3 opinion reversing the “Chevron doctrine” — which has been followed since a 1984 Court opinion — the Justices said that the judiciary should no longer have to defer to federal agency interpretations of laws. Existing federal law “requires courts to exercise their independent judgment in deciding whether an agency has acted within its statutory authority,” said the Court, in stating why Chevron should be overruled.

Writing for the majority in the combined cases — Relentless v. Department of Commerce and Loper Bright Enterprises v. Raimondo — Chief Justice John Roberts Jr. wrote that “agencies have no special competence in resolving statutory ambiguities. Courts do.”

In a dissenting opinion, Justice Elena Kagan said the decision was a judicial power grab and would result in a “jolt to the legal system.” She was joined by Justices Sonia Sotomayor and Ketanji Brown Jackson.

The opinion will have many repercussions, said lawyer and Supreme Court watcher Amy Howe. The Chevron ruling has been “one of the most important rulings on federal administrative law, cited by federal courts more than 18,000 times,” she wrote on her blog.

For example, without the long-standing deference to agencies under Chevron, healthcare providers may have more opportunities to challenge how federal officials set Medicare reimbursement for hospital procedures or prescription drugs, Baker Donelson healthcare attorneys McKenna Cloud and Thomas Barnard wrote in an analysis.

Seventeen health organizations issued a joint statement signaling their disappointment. 

“We anticipate that today’s ruling will cause significant disruption to publicly funded health insurance programs, to the stability of this country’s healthcare and food and drug review systems, and to the health and well-being of the patients and consumers we serve,” wrote the organizations, which included American Academy of Pediatrics, American Cancer Society, American Cancer Society Cancer Action Network, ALS Association, American Heart Association, American Lung Association, American Public Health Association, American Thoracic Society, Bazelon Center for Mental Health Law, Campaign for Tobacco-Free Kids, Child Neurology Foundation, Epilepsy Foundation, Muscular Dystrophy Association, National Health Law Program, Physicians for Social Responsibility, The Leukemia & Lymphoma Society, and Truth Initiative.

“It’s much harder for agencies to exercise power without some power to interpret statues. This is big,” wrote Berkeley Law Professor Orin Kerr on X.
 

A New, Uncertain Landscape for Healthcare

In the original Chevron case, the Court ruled that federal agencies had relevant expertise and should be given deference in resolving ambiguities that Congress had not spelled out in legislation.

In Relentless and Loper Bright, the plaintiffs argued that federal agencies overstepped their authority by issuing a rule that required commercial fishing vessels to pay for professional observers to monitor their catch.

In a statement after Friday’s ruling, the Relentless plaintiffs’ attorneys said that the decision “will recalibrate the balance of power between agencies and courts” and “make it harder for those agencies to adopt regulatory programs that exceed the authority conferred on them by Congress.”

Some predicted chaos in the wake of the ruling.

“Overturning Chevron could invite legal challenges to any and all agency determinations of ambiguous statutes by any stakeholder, leaving individual courts with the impractical task of determining the ‘correct’ meaning of statutes without the benefit of requisite expertise, practical experience, or public engagement,” wrote Sahil Agrawal, MD, PhD, Joseph S. Ross, MD, and Reshma Ramachandran, MD, in JAMA in an opinion piece in March that considered the ramifications of overturning Chevron.

“The spillover effects for medicine and public health, in turn, will be consequential,” they wrote.

In an analysis published in April, the Kaiser Family Foundation noted many potential ramifications on patient and consumer protections in the health insurance market. For instance, courts could vacate current rules governing protections under the Affordable Care Act, including that health plans offer a range of free preventive health services, such as breast, cervical, colon, and lung cancer screening.
 

Congressional, White House Reaction

Many legal observers said the ruling will have the effect of requiring Congress to write ever-more dense and exacting legislation to prevent agencies from interpreting any gaps.

Some members of Congress welcomed the decision.

Senate Minority Leader Mitch McConnell (R-Kentucky) said in a statement, “The Constitution vests Congress with the sole authority to make law,” adding, “the Supreme Court made it clear today that our system of government leaves no room for an unelected bureaucracy to co-opt this authority for itself.”

In a post on X, Senate Majority Leader Chuck Schumer (D-New York) accused the Court of siding with “special interests and giant corporations.” Added Mr. Schumer, “Their headlong rush to overturn 40 years of precedent and impose their own radical views is appalling.”

White House Press Secretary Karine Jean-Pierre said in a statement that “While this decision undermines the ability of federal agencies to use their expertise as Congress intended to make government work for the people, the Biden-Harris Administration will not relent in our efforts to protect and serve every American.”

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

Experts say the US Supreme Court’s ruling Friday to overturn the decades-old “Chevron doctrine” could severely restrict the ability of federal agencies to regulate all aspects of healthcare.

Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, wrote on X, “my worry is that it will paralyze policymaking in healthcare and other areas,” because “Congress will try to fill in more details, making it harder to pass legislation.” He also wrote that federal agencies “will become very cautious in using their regulatory authority.”

In their 6-3 opinion reversing the “Chevron doctrine” — which has been followed since a 1984 Court opinion — the Justices said that the judiciary should no longer have to defer to federal agency interpretations of laws. Existing federal law “requires courts to exercise their independent judgment in deciding whether an agency has acted within its statutory authority,” said the Court, in stating why Chevron should be overruled.

Writing for the majority in the combined cases — Relentless v. Department of Commerce and Loper Bright Enterprises v. Raimondo — Chief Justice John Roberts Jr. wrote that “agencies have no special competence in resolving statutory ambiguities. Courts do.”

In a dissenting opinion, Justice Elena Kagan said the decision was a judicial power grab and would result in a “jolt to the legal system.” She was joined by Justices Sonia Sotomayor and Ketanji Brown Jackson.

The opinion will have many repercussions, said lawyer and Supreme Court watcher Amy Howe. The Chevron ruling has been “one of the most important rulings on federal administrative law, cited by federal courts more than 18,000 times,” she wrote on her blog.

For example, without the long-standing deference to agencies under Chevron, healthcare providers may have more opportunities to challenge how federal officials set Medicare reimbursement for hospital procedures or prescription drugs, Baker Donelson healthcare attorneys McKenna Cloud and Thomas Barnard wrote in an analysis.

Seventeen health organizations issued a joint statement signaling their disappointment. 

“We anticipate that today’s ruling will cause significant disruption to publicly funded health insurance programs, to the stability of this country’s healthcare and food and drug review systems, and to the health and well-being of the patients and consumers we serve,” wrote the organizations, which included American Academy of Pediatrics, American Cancer Society, American Cancer Society Cancer Action Network, ALS Association, American Heart Association, American Lung Association, American Public Health Association, American Thoracic Society, Bazelon Center for Mental Health Law, Campaign for Tobacco-Free Kids, Child Neurology Foundation, Epilepsy Foundation, Muscular Dystrophy Association, National Health Law Program, Physicians for Social Responsibility, The Leukemia & Lymphoma Society, and Truth Initiative.

“It’s much harder for agencies to exercise power without some power to interpret statues. This is big,” wrote Berkeley Law Professor Orin Kerr on X.
 

A New, Uncertain Landscape for Healthcare

In the original Chevron case, the Court ruled that federal agencies had relevant expertise and should be given deference in resolving ambiguities that Congress had not spelled out in legislation.

In Relentless and Loper Bright, the plaintiffs argued that federal agencies overstepped their authority by issuing a rule that required commercial fishing vessels to pay for professional observers to monitor their catch.

In a statement after Friday’s ruling, the Relentless plaintiffs’ attorneys said that the decision “will recalibrate the balance of power between agencies and courts” and “make it harder for those agencies to adopt regulatory programs that exceed the authority conferred on them by Congress.”

Some predicted chaos in the wake of the ruling.

“Overturning Chevron could invite legal challenges to any and all agency determinations of ambiguous statutes by any stakeholder, leaving individual courts with the impractical task of determining the ‘correct’ meaning of statutes without the benefit of requisite expertise, practical experience, or public engagement,” wrote Sahil Agrawal, MD, PhD, Joseph S. Ross, MD, and Reshma Ramachandran, MD, in JAMA in an opinion piece in March that considered the ramifications of overturning Chevron.

“The spillover effects for medicine and public health, in turn, will be consequential,” they wrote.

In an analysis published in April, the Kaiser Family Foundation noted many potential ramifications on patient and consumer protections in the health insurance market. For instance, courts could vacate current rules governing protections under the Affordable Care Act, including that health plans offer a range of free preventive health services, such as breast, cervical, colon, and lung cancer screening.
 

Congressional, White House Reaction

Many legal observers said the ruling will have the effect of requiring Congress to write ever-more dense and exacting legislation to prevent agencies from interpreting any gaps.

Some members of Congress welcomed the decision.

Senate Minority Leader Mitch McConnell (R-Kentucky) said in a statement, “The Constitution vests Congress with the sole authority to make law,” adding, “the Supreme Court made it clear today that our system of government leaves no room for an unelected bureaucracy to co-opt this authority for itself.”

In a post on X, Senate Majority Leader Chuck Schumer (D-New York) accused the Court of siding with “special interests and giant corporations.” Added Mr. Schumer, “Their headlong rush to overturn 40 years of precedent and impose their own radical views is appalling.”

White House Press Secretary Karine Jean-Pierre said in a statement that “While this decision undermines the ability of federal agencies to use their expertise as Congress intended to make government work for the people, the Biden-Harris Administration will not relent in our efforts to protect and serve every American.”

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

Experts say the US Supreme Court’s ruling Friday to overturn the decades-old “Chevron doctrine” could severely restrict the ability of federal agencies to regulate all aspects of healthcare.

Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, wrote on X, “my worry is that it will paralyze policymaking in healthcare and other areas,” because “Congress will try to fill in more details, making it harder to pass legislation.” He also wrote that federal agencies “will become very cautious in using their regulatory authority.”

In their 6-3 opinion reversing the “Chevron doctrine” — which has been followed since a 1984 Court opinion — the Justices said that the judiciary should no longer have to defer to federal agency interpretations of laws. Existing federal law “requires courts to exercise their independent judgment in deciding whether an agency has acted within its statutory authority,” said the Court, in stating why Chevron should be overruled.

Writing for the majority in the combined cases — Relentless v. Department of Commerce and Loper Bright Enterprises v. Raimondo — Chief Justice John Roberts Jr. wrote that “agencies have no special competence in resolving statutory ambiguities. Courts do.”

In a dissenting opinion, Justice Elena Kagan said the decision was a judicial power grab and would result in a “jolt to the legal system.” She was joined by Justices Sonia Sotomayor and Ketanji Brown Jackson.

The opinion will have many repercussions, said lawyer and Supreme Court watcher Amy Howe. The Chevron ruling has been “one of the most important rulings on federal administrative law, cited by federal courts more than 18,000 times,” she wrote on her blog.

For example, without the long-standing deference to agencies under Chevron, healthcare providers may have more opportunities to challenge how federal officials set Medicare reimbursement for hospital procedures or prescription drugs, Baker Donelson healthcare attorneys McKenna Cloud and Thomas Barnard wrote in an analysis.

Seventeen health organizations issued a joint statement signaling their disappointment. 

“We anticipate that today’s ruling will cause significant disruption to publicly funded health insurance programs, to the stability of this country’s healthcare and food and drug review systems, and to the health and well-being of the patients and consumers we serve,” wrote the organizations, which included American Academy of Pediatrics, American Cancer Society, American Cancer Society Cancer Action Network, ALS Association, American Heart Association, American Lung Association, American Public Health Association, American Thoracic Society, Bazelon Center for Mental Health Law, Campaign for Tobacco-Free Kids, Child Neurology Foundation, Epilepsy Foundation, Muscular Dystrophy Association, National Health Law Program, Physicians for Social Responsibility, The Leukemia & Lymphoma Society, and Truth Initiative.

“It’s much harder for agencies to exercise power without some power to interpret statues. This is big,” wrote Berkeley Law Professor Orin Kerr on X.
 

A New, Uncertain Landscape for Healthcare

In the original Chevron case, the Court ruled that federal agencies had relevant expertise and should be given deference in resolving ambiguities that Congress had not spelled out in legislation.

In Relentless and Loper Bright, the plaintiffs argued that federal agencies overstepped their authority by issuing a rule that required commercial fishing vessels to pay for professional observers to monitor their catch.

In a statement after Friday’s ruling, the Relentless plaintiffs’ attorneys said that the decision “will recalibrate the balance of power between agencies and courts” and “make it harder for those agencies to adopt regulatory programs that exceed the authority conferred on them by Congress.”

Some predicted chaos in the wake of the ruling.

“Overturning Chevron could invite legal challenges to any and all agency determinations of ambiguous statutes by any stakeholder, leaving individual courts with the impractical task of determining the ‘correct’ meaning of statutes without the benefit of requisite expertise, practical experience, or public engagement,” wrote Sahil Agrawal, MD, PhD, Joseph S. Ross, MD, and Reshma Ramachandran, MD, in JAMA in an opinion piece in March that considered the ramifications of overturning Chevron.

“The spillover effects for medicine and public health, in turn, will be consequential,” they wrote.

In an analysis published in April, the Kaiser Family Foundation noted many potential ramifications on patient and consumer protections in the health insurance market. For instance, courts could vacate current rules governing protections under the Affordable Care Act, including that health plans offer a range of free preventive health services, such as breast, cervical, colon, and lung cancer screening.
 

Congressional, White House Reaction

Many legal observers said the ruling will have the effect of requiring Congress to write ever-more dense and exacting legislation to prevent agencies from interpreting any gaps.

Some members of Congress welcomed the decision.

Senate Minority Leader Mitch McConnell (R-Kentucky) said in a statement, “The Constitution vests Congress with the sole authority to make law,” adding, “the Supreme Court made it clear today that our system of government leaves no room for an unelected bureaucracy to co-opt this authority for itself.”

In a post on X, Senate Majority Leader Chuck Schumer (D-New York) accused the Court of siding with “special interests and giant corporations.” Added Mr. Schumer, “Their headlong rush to overturn 40 years of precedent and impose their own radical views is appalling.”

White House Press Secretary Karine Jean-Pierre said in a statement that “While this decision undermines the ability of federal agencies to use their expertise as Congress intended to make government work for the people, the Biden-Harris Administration will not relent in our efforts to protect and serve every American.”

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

Two hospitals in California in recent months have been cited by state inspectors for allowing certified registered nurse anesthetists (CRNAs) to practice beyond their scope, leading to one hospital temporarily stopping use of CRNAs in surgeries.

In one case, a CRNA changed a physician’s order from general anesthesia to spinal anesthesia for a patient who later became unresponsive and had to be transferred to another hospital, according to The Modesto Bee.

The unusual situation highlights the ongoing, often contentious debate about the proper role of CRNAs in surgery amid widely varying state scope of practice laws.

Elizabeth Bamgbose, CRNA, past president of the California Association of Nurse Anesthetists (CANA), said that the absence of CRNAs at Doctors Medical Center (DMC) in Modesto, California, had led to the cancellation of hundreds of procedures. It was an unnecessary step, she said.

“It’s unfortunate that a single surveyor has taken it upon themselves to reinterpret state regulations and redefine a practice that was efficient and safe,” said Ms. Bamgbose, a member of the CANA practice committee.

In late May, the California Department of Public Health (CDPH) issued an “immediate jeopardy” warning about DMC of Modesto. The state agency, like its counterparts in other states, acts on behalf of the Centers for Medicare and Medicaid Services (CMS) in surveying healthcare facilities. CMS defines immediate jeopardy as “a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death.”

The administrative warning comes with fines and requires the facility to submit an action plan to remediate the situation. The state determines through a follow-up survey whether the plan is sufficient for the facility to avoid being dropped from participation in Medicare and Medicaid.

Before the immediate jeopardy action was taken against DMC, the state had issued three previous such warnings in 2024, according to the CDPH enforcement actions dashboard.
 

CRNA Claims to Be in Charge

Stanislaus Surgical Hospital in Modesto, California, was the first facility to attract CDPH attention. It reportedly was cited in August 2023 and January 2024 surveys for a number of violations of the CMS conditions of participation, including allowing nurse anesthetists to practice beyond their scope.

According to The Modesto Bee, CDPH issued an “immediate jeopardy” order for Stanislaus in January.

The paper reported that state regulators took issue with a CRNA claiming to be the lead manager of the hospital’s anesthesia group, referring to herself as the “chief CRNA.”

Jennifer Banek, MSN, CRNA, a member of the American Association of Nurse Anesthesiology board, declined comment on the Stanislaus hospital but said that “it would not be unusual for a nurse anesthetist to serve as a leader, especially (for a) rural or underserved population.”

In April, CMS informed Stanislaus it was being terminated from Medicare, but several Congressional representatives from the Modesto area asked CMS to reconsider. The agency eventually reversed the sanction, The Modesto Bee reported.

CDPH subsequently cited DMC for CRNA scope of practice issues. A department spokesman said that CDPH teams went to DMC “to investigate practices that may not be compliant with state and federal requirements.” The agency declined to comment further until its investigations were complete.

CDPH is monitoring DMC to ensure the hospital complies with state requirements and will return for an unannounced follow-up survey “so it can provide safe, high-quality care to patients that need it,” the spokesperson said.

Although DMC would not confirm it on the record, the immediate jeopardy order led to the removal of all CRNAs, according to Ms. Banek, Ms. Bamgbose, and The Modesto Bee.

The hospital said in a statement that it is working with CDPH to address its concerns and will await a follow-up survey. “Our hospital will continue to fully participate in the Medicare and Medicaid programs during this process.”
 

Scope of Practice Confusion?

Federal and state laws and hospital bylaws all prescribe what falls within the scope of practice for a CRNA, but uncertainty remains.

Twenty-five states — including California — have legally opted out of the federal CMS requirement that a physician supervise CRNAs.

But that does not supersede state laws or hospital bylaws governing practice, said American Society of Anesthesiologists (ASA) president Ronald Harter, MD.

Five states — Alaska, Delaware, Montana, New Hampshire, and Oregon — have laws that allow nurse anesthetists to practice without physician oversight or involvement, said Dr. Harter, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus, Ohio.

“There’s a lot of various opinions on what exactly constitutes scope of practice of a nurse anesthetist,” Dr. Harter said. “The vast majority of them work under the direction of an anesthesiologist, and in those settings, it’s typically very clear to everybody who performs what tasks within the care team,” he said.

It’s less common for nurse anesthetists to work totally independent of physician oversight, he said.

Ms. Bamgbose, however, said there is no California statute requiring physician supervision of CRNAs.

The ASA maintains that CRNAs should always be under the supervision of a physician, which can be an anesthesiologist, obstetrician, gastroenterologist, surgeon, or other physician conducting a procedure. An anesthesiologist does not necessarily have to be physically on site, but in those circumstances, the physician conducting the procedure would be, said Dr. Harter.

Nurse anesthetists are “excellent advanced practice nurses,” Dr. Harter said. “But they haven’t been to medical school; they haven’t conducted a residency in anesthesiology. [They] don’t have the medical knowledge and skills that are required to manage the medical problems that patients either bring to the OR with them or that can arise during the time that they’re under anesthesia.”
 

Filling a Gap

Nurse anesthetists see things differently.

CRNAs, by virtue of their certification, can “practice to the full extent and to the full scope, which is complete service of anesthesia,” said Ms. Bamgbose. “You can practice independently of anyone, any type of supervision,” she said.

She acknowledges that “the bylaws of any institution will govern the scope at which any healthcare professional can practice at that institution.”

Most nurse anesthetists see themselves as independent practitioners.

Seventy-five percent of CRNAs who responded to a 2023 Medscape Medical News survey said they practice independently. But even Ms. Banek said that often, the meaning of “independent” is in the eye of the beholder. “It could mean different things to various providers, especially depending on the state that they are residing in,” she said.

Ms. Banek and Ms. Bamgbose said that CRNAs can help fill a gap in anesthesiology services in underserved areas.

The Bureau of Labor Statistics estimates there are currently 32,530 anesthesiologists in the United States, with California employing the largest number, at about 5300. The Association of American Medical Colleges estimated the number at 42,263 in 2022. But the federal Health Resources and Services Administration projects a shortage of 6300 anesthesiologists over the next 15 years.

Some 61,000 CRNAs are currently practicing, with 2400 graduating each year. They are required to be board-certified and are recredentialed every 4 years. By 2025, all will be required to have a doctoral degree. Most have already achieved that status, said Ms. Banek.

“Nurse anesthetists provide care predominantly to rural and underserved areas,” she said, adding, “In many rural hospitals across the country and in all three branches of the military, CRNAs practice autonomously.”

There are 3000 CRNAs in California, said Ms. Bamgbose. Nurse anesthetists are the only anesthesiology professionals in four of 58 California counties, she said.

Ms. Banek said she had heard that some 200 cases were canceled in 1 week at DMC due to the lack of CRNAs. Having physician supervision, which she called redundant, “is really creating a barrier to care,” she said.

“We have countless state and national studies that show the safety and efficacy of our practice,” said Ms. Bamgbose. “To interrupt that care ... is incredibly disruptive to the system.”

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

Two hospitals in California in recent months have been cited by state inspectors for allowing certified registered nurse anesthetists (CRNAs) to practice beyond their scope, leading to one hospital temporarily stopping use of CRNAs in surgeries.

In one case, a CRNA changed a physician’s order from general anesthesia to spinal anesthesia for a patient who later became unresponsive and had to be transferred to another hospital, according to The Modesto Bee.

The unusual situation highlights the ongoing, often contentious debate about the proper role of CRNAs in surgery amid widely varying state scope of practice laws.

Elizabeth Bamgbose, CRNA, past president of the California Association of Nurse Anesthetists (CANA), said that the absence of CRNAs at Doctors Medical Center (DMC) in Modesto, California, had led to the cancellation of hundreds of procedures. It was an unnecessary step, she said.

“It’s unfortunate that a single surveyor has taken it upon themselves to reinterpret state regulations and redefine a practice that was efficient and safe,” said Ms. Bamgbose, a member of the CANA practice committee.

In late May, the California Department of Public Health (CDPH) issued an “immediate jeopardy” warning about DMC of Modesto. The state agency, like its counterparts in other states, acts on behalf of the Centers for Medicare and Medicaid Services (CMS) in surveying healthcare facilities. CMS defines immediate jeopardy as “a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death.”

The administrative warning comes with fines and requires the facility to submit an action plan to remediate the situation. The state determines through a follow-up survey whether the plan is sufficient for the facility to avoid being dropped from participation in Medicare and Medicaid.

Before the immediate jeopardy action was taken against DMC, the state had issued three previous such warnings in 2024, according to the CDPH enforcement actions dashboard.
 

CRNA Claims to Be in Charge

Stanislaus Surgical Hospital in Modesto, California, was the first facility to attract CDPH attention. It reportedly was cited in August 2023 and January 2024 surveys for a number of violations of the CMS conditions of participation, including allowing nurse anesthetists to practice beyond their scope.

According to The Modesto Bee, CDPH issued an “immediate jeopardy” order for Stanislaus in January.

The paper reported that state regulators took issue with a CRNA claiming to be the lead manager of the hospital’s anesthesia group, referring to herself as the “chief CRNA.”

Jennifer Banek, MSN, CRNA, a member of the American Association of Nurse Anesthesiology board, declined comment on the Stanislaus hospital but said that “it would not be unusual for a nurse anesthetist to serve as a leader, especially (for a) rural or underserved population.”

In April, CMS informed Stanislaus it was being terminated from Medicare, but several Congressional representatives from the Modesto area asked CMS to reconsider. The agency eventually reversed the sanction, The Modesto Bee reported.

CDPH subsequently cited DMC for CRNA scope of practice issues. A department spokesman said that CDPH teams went to DMC “to investigate practices that may not be compliant with state and federal requirements.” The agency declined to comment further until its investigations were complete.

CDPH is monitoring DMC to ensure the hospital complies with state requirements and will return for an unannounced follow-up survey “so it can provide safe, high-quality care to patients that need it,” the spokesperson said.

Although DMC would not confirm it on the record, the immediate jeopardy order led to the removal of all CRNAs, according to Ms. Banek, Ms. Bamgbose, and The Modesto Bee.

The hospital said in a statement that it is working with CDPH to address its concerns and will await a follow-up survey. “Our hospital will continue to fully participate in the Medicare and Medicaid programs during this process.”
 

Scope of Practice Confusion?

Federal and state laws and hospital bylaws all prescribe what falls within the scope of practice for a CRNA, but uncertainty remains.

Twenty-five states — including California — have legally opted out of the federal CMS requirement that a physician supervise CRNAs.

But that does not supersede state laws or hospital bylaws governing practice, said American Society of Anesthesiologists (ASA) president Ronald Harter, MD.

Five states — Alaska, Delaware, Montana, New Hampshire, and Oregon — have laws that allow nurse anesthetists to practice without physician oversight or involvement, said Dr. Harter, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus, Ohio.

“There’s a lot of various opinions on what exactly constitutes scope of practice of a nurse anesthetist,” Dr. Harter said. “The vast majority of them work under the direction of an anesthesiologist, and in those settings, it’s typically very clear to everybody who performs what tasks within the care team,” he said.

It’s less common for nurse anesthetists to work totally independent of physician oversight, he said.

Ms. Bamgbose, however, said there is no California statute requiring physician supervision of CRNAs.

The ASA maintains that CRNAs should always be under the supervision of a physician, which can be an anesthesiologist, obstetrician, gastroenterologist, surgeon, or other physician conducting a procedure. An anesthesiologist does not necessarily have to be physically on site, but in those circumstances, the physician conducting the procedure would be, said Dr. Harter.

Nurse anesthetists are “excellent advanced practice nurses,” Dr. Harter said. “But they haven’t been to medical school; they haven’t conducted a residency in anesthesiology. [They] don’t have the medical knowledge and skills that are required to manage the medical problems that patients either bring to the OR with them or that can arise during the time that they’re under anesthesia.”
 

Filling a Gap

Nurse anesthetists see things differently.

CRNAs, by virtue of their certification, can “practice to the full extent and to the full scope, which is complete service of anesthesia,” said Ms. Bamgbose. “You can practice independently of anyone, any type of supervision,” she said.

She acknowledges that “the bylaws of any institution will govern the scope at which any healthcare professional can practice at that institution.”

Most nurse anesthetists see themselves as independent practitioners.

Seventy-five percent of CRNAs who responded to a 2023 Medscape Medical News survey said they practice independently. But even Ms. Banek said that often, the meaning of “independent” is in the eye of the beholder. “It could mean different things to various providers, especially depending on the state that they are residing in,” she said.

Ms. Banek and Ms. Bamgbose said that CRNAs can help fill a gap in anesthesiology services in underserved areas.

The Bureau of Labor Statistics estimates there are currently 32,530 anesthesiologists in the United States, with California employing the largest number, at about 5300. The Association of American Medical Colleges estimated the number at 42,263 in 2022. But the federal Health Resources and Services Administration projects a shortage of 6300 anesthesiologists over the next 15 years.

Some 61,000 CRNAs are currently practicing, with 2400 graduating each year. They are required to be board-certified and are recredentialed every 4 years. By 2025, all will be required to have a doctoral degree. Most have already achieved that status, said Ms. Banek.

“Nurse anesthetists provide care predominantly to rural and underserved areas,” she said, adding, “In many rural hospitals across the country and in all three branches of the military, CRNAs practice autonomously.”

There are 3000 CRNAs in California, said Ms. Bamgbose. Nurse anesthetists are the only anesthesiology professionals in four of 58 California counties, she said.

Ms. Banek said she had heard that some 200 cases were canceled in 1 week at DMC due to the lack of CRNAs. Having physician supervision, which she called redundant, “is really creating a barrier to care,” she said.

“We have countless state and national studies that show the safety and efficacy of our practice,” said Ms. Bamgbose. “To interrupt that care ... is incredibly disruptive to the system.”

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

Two hospitals in California in recent months have been cited by state inspectors for allowing certified registered nurse anesthetists (CRNAs) to practice beyond their scope, leading to one hospital temporarily stopping use of CRNAs in surgeries.

In one case, a CRNA changed a physician’s order from general anesthesia to spinal anesthesia for a patient who later became unresponsive and had to be transferred to another hospital, according to The Modesto Bee.

The unusual situation highlights the ongoing, often contentious debate about the proper role of CRNAs in surgery amid widely varying state scope of practice laws.

Elizabeth Bamgbose, CRNA, past president of the California Association of Nurse Anesthetists (CANA), said that the absence of CRNAs at Doctors Medical Center (DMC) in Modesto, California, had led to the cancellation of hundreds of procedures. It was an unnecessary step, she said.

“It’s unfortunate that a single surveyor has taken it upon themselves to reinterpret state regulations and redefine a practice that was efficient and safe,” said Ms. Bamgbose, a member of the CANA practice committee.

In late May, the California Department of Public Health (CDPH) issued an “immediate jeopardy” warning about DMC of Modesto. The state agency, like its counterparts in other states, acts on behalf of the Centers for Medicare and Medicaid Services (CMS) in surveying healthcare facilities. CMS defines immediate jeopardy as “a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death.”

The administrative warning comes with fines and requires the facility to submit an action plan to remediate the situation. The state determines through a follow-up survey whether the plan is sufficient for the facility to avoid being dropped from participation in Medicare and Medicaid.

Before the immediate jeopardy action was taken against DMC, the state had issued three previous such warnings in 2024, according to the CDPH enforcement actions dashboard.
 

CRNA Claims to Be in Charge

Stanislaus Surgical Hospital in Modesto, California, was the first facility to attract CDPH attention. It reportedly was cited in August 2023 and January 2024 surveys for a number of violations of the CMS conditions of participation, including allowing nurse anesthetists to practice beyond their scope.

According to The Modesto Bee, CDPH issued an “immediate jeopardy” order for Stanislaus in January.

The paper reported that state regulators took issue with a CRNA claiming to be the lead manager of the hospital’s anesthesia group, referring to herself as the “chief CRNA.”

Jennifer Banek, MSN, CRNA, a member of the American Association of Nurse Anesthesiology board, declined comment on the Stanislaus hospital but said that “it would not be unusual for a nurse anesthetist to serve as a leader, especially (for a) rural or underserved population.”

In April, CMS informed Stanislaus it was being terminated from Medicare, but several Congressional representatives from the Modesto area asked CMS to reconsider. The agency eventually reversed the sanction, The Modesto Bee reported.

CDPH subsequently cited DMC for CRNA scope of practice issues. A department spokesman said that CDPH teams went to DMC “to investigate practices that may not be compliant with state and federal requirements.” The agency declined to comment further until its investigations were complete.

CDPH is monitoring DMC to ensure the hospital complies with state requirements and will return for an unannounced follow-up survey “so it can provide safe, high-quality care to patients that need it,” the spokesperson said.

Although DMC would not confirm it on the record, the immediate jeopardy order led to the removal of all CRNAs, according to Ms. Banek, Ms. Bamgbose, and The Modesto Bee.

The hospital said in a statement that it is working with CDPH to address its concerns and will await a follow-up survey. “Our hospital will continue to fully participate in the Medicare and Medicaid programs during this process.”
 

Scope of Practice Confusion?

Federal and state laws and hospital bylaws all prescribe what falls within the scope of practice for a CRNA, but uncertainty remains.

Twenty-five states — including California — have legally opted out of the federal CMS requirement that a physician supervise CRNAs.

But that does not supersede state laws or hospital bylaws governing practice, said American Society of Anesthesiologists (ASA) president Ronald Harter, MD.

Five states — Alaska, Delaware, Montana, New Hampshire, and Oregon — have laws that allow nurse anesthetists to practice without physician oversight or involvement, said Dr. Harter, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus, Ohio.

“There’s a lot of various opinions on what exactly constitutes scope of practice of a nurse anesthetist,” Dr. Harter said. “The vast majority of them work under the direction of an anesthesiologist, and in those settings, it’s typically very clear to everybody who performs what tasks within the care team,” he said.

It’s less common for nurse anesthetists to work totally independent of physician oversight, he said.

Ms. Bamgbose, however, said there is no California statute requiring physician supervision of CRNAs.

The ASA maintains that CRNAs should always be under the supervision of a physician, which can be an anesthesiologist, obstetrician, gastroenterologist, surgeon, or other physician conducting a procedure. An anesthesiologist does not necessarily have to be physically on site, but in those circumstances, the physician conducting the procedure would be, said Dr. Harter.

Nurse anesthetists are “excellent advanced practice nurses,” Dr. Harter said. “But they haven’t been to medical school; they haven’t conducted a residency in anesthesiology. [They] don’t have the medical knowledge and skills that are required to manage the medical problems that patients either bring to the OR with them or that can arise during the time that they’re under anesthesia.”
 

Filling a Gap

Nurse anesthetists see things differently.

CRNAs, by virtue of their certification, can “practice to the full extent and to the full scope, which is complete service of anesthesia,” said Ms. Bamgbose. “You can practice independently of anyone, any type of supervision,” she said.

She acknowledges that “the bylaws of any institution will govern the scope at which any healthcare professional can practice at that institution.”

Most nurse anesthetists see themselves as independent practitioners.

Seventy-five percent of CRNAs who responded to a 2023 Medscape Medical News survey said they practice independently. But even Ms. Banek said that often, the meaning of “independent” is in the eye of the beholder. “It could mean different things to various providers, especially depending on the state that they are residing in,” she said.

Ms. Banek and Ms. Bamgbose said that CRNAs can help fill a gap in anesthesiology services in underserved areas.

The Bureau of Labor Statistics estimates there are currently 32,530 anesthesiologists in the United States, with California employing the largest number, at about 5300. The Association of American Medical Colleges estimated the number at 42,263 in 2022. But the federal Health Resources and Services Administration projects a shortage of 6300 anesthesiologists over the next 15 years.

Some 61,000 CRNAs are currently practicing, with 2400 graduating each year. They are required to be board-certified and are recredentialed every 4 years. By 2025, all will be required to have a doctoral degree. Most have already achieved that status, said Ms. Banek.

“Nurse anesthetists provide care predominantly to rural and underserved areas,” she said, adding, “In many rural hospitals across the country and in all three branches of the military, CRNAs practice autonomously.”

There are 3000 CRNAs in California, said Ms. Bamgbose. Nurse anesthetists are the only anesthesiology professionals in four of 58 California counties, she said.

Ms. Banek said she had heard that some 200 cases were canceled in 1 week at DMC due to the lack of CRNAs. Having physician supervision, which she called redundant, “is really creating a barrier to care,” she said.

“We have countless state and national studies that show the safety and efficacy of our practice,” said Ms. Bamgbose. “To interrupt that care ... is incredibly disruptive to the system.”

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

When he completed his fellowship at Fox Chase Cancer Center in Philadelphia, Moshe Chasky, MD, joined a small five-person practice that rented space from the city’s Jefferson Hospital in Philadelphia. The arrangement seemed to work well for the hospital and the small practice, which remained independent.

Within 10 years, the hospital sought to buy the practice, Alliance Cancer Specialists.

But the oncologists at Alliance did not want to join Jefferson.

The hospital eventually entered into an exclusive agreement with its own medical group to provide inpatient oncology/hematology services at three Jefferson Health–Northeast hospitals and stripped Dr. Chasky and his colleagues of their privileges at those facilities, Medscape Medical News reported last year.

The Alliance story is a familiar one for independent community oncology practices, said Jeff Patton, MD, CEO of OneOncology, a management services organization.

A 2020 report from the Community Oncology Alliance (COA), for instance, tracked mergers, acquisitions, and closures in the community oncology setting and found the number of practices acquired by hospitals, known as vertical integration, nearly tripled from 2010 to 2020.

“Some hospitals are pretty predatory in their approach,” Dr. Patton said. If hospitals have their own oncology program, “they’ll employ the referring doctors and then discourage them or prevent them from referring patients to our independent practices that are not owned by the hospital.”

Still, in the face of growing pressure to join hospitals, some community oncology practices are finding ways to survive and maintain their independence.
 

A Growing Trend

The latest data continue to show a clear trend: Consolidation in oncology is on the rise.

A 2024 study revealed that the pace of consolidation seems to be increasing.

The analysis found that, between 2015 and 2022, the number of medical oncologists increased by 14% and the number of medical oncologists per practice increased by 40%, while the number of practices decreased by 18%.

While about 44% of practices remain independent, the percentage of medical oncologists working in practices with more than 25 clinicians has increased from 34% in 2015 to 44% in 2022. By 2022, the largest 102 practices in the United States employed more than 40% of all medical oncologists.

“The rate of consolidation seems to be rapid,” study coauthor Parsa Erfani, MD, an internal medicine resident at Brigham & Women’s Hospital, Boston, explained.

Consolidation appears to breed more consolidation. The researchers found, for instance, that markets with greater hospital consolidation and more hospital beds per capita were more likely to undergo consolidation in oncology.

Consolidation may be higher in these markets “because hospitals or health systems are buying up oncology practices or conversely because oncology practices are merging to compete more effectively with larger hospitals in the area,” Dr. Erfani told this news organization.

Mergers among independent practices, known as horizontal integration, have also been on the rise, according to the 2020 COA report. These mergers can help counter pressures from hospitals seeking to acquire community practices as well as prevent practices and their clinics from closing.

Although Dr. Erfani’s research wasn’t designed to determine the factors behind consolidation, he and his colleagues point to the Affordable Care Act (ACA) and the federal 340B Drug Pricing Program as potential drivers of this trend.

The ACA encouraged consolidation as a way to improve efficiency and created the need for ever-larger information systems to collect and report quality data. But these data collection and reporting requirements have become increasingly difficult for smaller practices to take on.

The 340B Program, however, may be a bigger contributing factor to consolidation. Created in 1992, the 340B Program allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy outpatient prescription drugs at a 25%-50% discount.

Hospitals seeking to capitalize on the margins possible under the 340B Program will “buy all the referring physicians in a market so that the medical oncology group is left with little choice but to sell to the hospital,” said Dr. Patton.

“Those 340B dollars are worth a lot to hospitals,” said David A. Eagle, MD, a hematologist/oncologist with New York Cancer & Blood Specialists and past president of COA. The program “creates an appetite for nonprofit hospitals to want to grow their medical oncology programs,” he told this news organization.

Declining Medicare reimbursement has also hit independent practices hard.

Over the past 15 years, compared with inflation, physicians have gotten “a pay rate decrease from Medicare,” said Dr. Patton. Payers have followed that lead and tried to cut pay for clinicians, especially those who do not have market share, he said. Paying them less is “disingenuous knowing that our costs of providing care are going up,” he said.
 

Less Access, Higher Costs, Worse Care?

Many studies have demonstrated that, when hospitals become behemoths in a given market, healthcare costs go up.

“There are robust data showing that consolidation increases healthcare costs by reducing competition, including in oncology,” wrote Dr. Erfani and colleagues.

Oncology practices that are owned by hospitals bill facility fees for outpatient chemotherapy treatment, adding another layer of cost, the researchers explained, citing a 2019 Health Economics study.

Another analysis, published in 2020, found that hospital prices for the top 37 infused cancer drugs averaged 86% more per unit than the price charged by physician offices. Hospital outpatient departments charged even more, on average, for drugs — 128% more for nivolumab and 428% more for fluorouracil, for instance.

In their 2024 analysis, Dr. Erfani and colleagues also found that increased hospital market concentration was associated with worse quality of care, across all assessed patient satisfaction measures, and may result in worse access to care as well.

Overall, these consolidation “trends have important implications for cancer care cost, quality, and access,” the authors concluded.
 

Navigating the Consolidation Trend

In the face of mounting pressure to join hospitals, community oncology practices have typically relied on horizontal mergers to maintain their independence. An increasing number of practices, however, are now turning to another strategy: Management services organizations.

According to some oncologists, a core benefit of joining a management services organization is their community practices can maintain autonomy, hold on to referrals, and benefit from access to a wider network of peers and recently approved treatments such as chimeric antigen receptor T-cell therapies.

In these arrangements, the management company also provides business assistance to practices, including help with billing and collection, payer negotiations, supply chain issues, and credentialing, as well as recruiting, hiring, and marketing.

These management organizations, which include American Oncology Network, Integrated Oncology Network, OneOncology, and Verdi Oncology, are, however, backed by private equity. According to a 2022 report, private equity–backed management organizations have ramped up arrangements with community oncology practices over the past few years — a trend that has concerned some experts.

The authors of a recent analysis in JAMA Internal Medicine explained that, although private equity involvement in physician practices may enable operational efficiencies, “critics point to potential conflicts of interest” and highlight concerns that patients “may face additional barriers to both accessibility and affordability of care.”

The difference, according to some oncologists, is their practices are not owned by the management services organization; instead, the practices enter contracts that outline the boundaries of the relationship and stipulate fees to the management organizations.

In 2020, Dr. Chasky’s practice, Alliance Cancer Specialists, joined The US Oncology Network, a management services organization wholly owned by McKesson. The organization provides the practice with capital and other resources, as well as access to the Sarah Cannon Research Institute, so patients can participate in clinical trials.

“We totally function as an independent practice,” said Dr. Chasky. “We make our own management decisions,” he said. For instance, if Alliance wants to hire a new clinician, US Oncology helps with the recruitment. “But at the end of the day, it’s our practice,” he said.

Davey Daniel, MD — whose community practice joined the management services organization OneOncology — has seen the benefits of being part of a larger network. For instance, bispecific therapies for leukemias, lymphomas, and multiple myeloma are typically administered at academic centers because of the risk for cytokine release syndrome.

However, physician leaders in the OneOncology network “came up with a playbook on how to do it safely” in the community setting, said Dr. Daniel. “It meant that we were adopting FDA newly approved therapies in a very short course.”

Being able to draw from a wider pool of expertise has had other advantages. Dr. Daniel can lean on pathologists and research scientists in the network for advice on targeted therapy use. “We’re actually bringing precision medicine expertise to the community,” Dr. Daniel said.

Dr. Chasky and Dr. Eagle, whose practice is also part of OneOncology, said that continuing to work in the community setting has allowed them greater flexibility.

Dr. Eagle explained that New York Cancer & Blood Specialists tries to offer patients an appointment within 2 days of a referral, and it allows walk-in visits.

Dr. Chasky leans into the flexibility by having staff stay late, when needed, to ensure that all patients are seen. “We’re there for our patients at all hours,” Dr. Chasky said, adding that often “you don’t have that flexibility when you work for a big hospital system.”

The bottom line is community oncology can still thrive, said Nick Ferreyros, managing director of COA, “as long as we have a healthy competitive ecosystem where [we] are valued and seen as an important part of our cancer care system.”

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

When he completed his fellowship at Fox Chase Cancer Center in Philadelphia, Moshe Chasky, MD, joined a small five-person practice that rented space from the city’s Jefferson Hospital in Philadelphia. The arrangement seemed to work well for the hospital and the small practice, which remained independent.

Within 10 years, the hospital sought to buy the practice, Alliance Cancer Specialists.

But the oncologists at Alliance did not want to join Jefferson.

The hospital eventually entered into an exclusive agreement with its own medical group to provide inpatient oncology/hematology services at three Jefferson Health–Northeast hospitals and stripped Dr. Chasky and his colleagues of their privileges at those facilities, Medscape Medical News reported last year.

The Alliance story is a familiar one for independent community oncology practices, said Jeff Patton, MD, CEO of OneOncology, a management services organization.

A 2020 report from the Community Oncology Alliance (COA), for instance, tracked mergers, acquisitions, and closures in the community oncology setting and found the number of practices acquired by hospitals, known as vertical integration, nearly tripled from 2010 to 2020.

“Some hospitals are pretty predatory in their approach,” Dr. Patton said. If hospitals have their own oncology program, “they’ll employ the referring doctors and then discourage them or prevent them from referring patients to our independent practices that are not owned by the hospital.”

Still, in the face of growing pressure to join hospitals, some community oncology practices are finding ways to survive and maintain their independence.
 

A Growing Trend

The latest data continue to show a clear trend: Consolidation in oncology is on the rise.

A 2024 study revealed that the pace of consolidation seems to be increasing.

The analysis found that, between 2015 and 2022, the number of medical oncologists increased by 14% and the number of medical oncologists per practice increased by 40%, while the number of practices decreased by 18%.

While about 44% of practices remain independent, the percentage of medical oncologists working in practices with more than 25 clinicians has increased from 34% in 2015 to 44% in 2022. By 2022, the largest 102 practices in the United States employed more than 40% of all medical oncologists.

“The rate of consolidation seems to be rapid,” study coauthor Parsa Erfani, MD, an internal medicine resident at Brigham & Women’s Hospital, Boston, explained.

Consolidation appears to breed more consolidation. The researchers found, for instance, that markets with greater hospital consolidation and more hospital beds per capita were more likely to undergo consolidation in oncology.

Consolidation may be higher in these markets “because hospitals or health systems are buying up oncology practices or conversely because oncology practices are merging to compete more effectively with larger hospitals in the area,” Dr. Erfani told this news organization.

Mergers among independent practices, known as horizontal integration, have also been on the rise, according to the 2020 COA report. These mergers can help counter pressures from hospitals seeking to acquire community practices as well as prevent practices and their clinics from closing.

Although Dr. Erfani’s research wasn’t designed to determine the factors behind consolidation, he and his colleagues point to the Affordable Care Act (ACA) and the federal 340B Drug Pricing Program as potential drivers of this trend.

The ACA encouraged consolidation as a way to improve efficiency and created the need for ever-larger information systems to collect and report quality data. But these data collection and reporting requirements have become increasingly difficult for smaller practices to take on.

The 340B Program, however, may be a bigger contributing factor to consolidation. Created in 1992, the 340B Program allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy outpatient prescription drugs at a 25%-50% discount.

Hospitals seeking to capitalize on the margins possible under the 340B Program will “buy all the referring physicians in a market so that the medical oncology group is left with little choice but to sell to the hospital,” said Dr. Patton.

“Those 340B dollars are worth a lot to hospitals,” said David A. Eagle, MD, a hematologist/oncologist with New York Cancer & Blood Specialists and past president of COA. The program “creates an appetite for nonprofit hospitals to want to grow their medical oncology programs,” he told this news organization.

Declining Medicare reimbursement has also hit independent practices hard.

Over the past 15 years, compared with inflation, physicians have gotten “a pay rate decrease from Medicare,” said Dr. Patton. Payers have followed that lead and tried to cut pay for clinicians, especially those who do not have market share, he said. Paying them less is “disingenuous knowing that our costs of providing care are going up,” he said.
 

Less Access, Higher Costs, Worse Care?

Many studies have demonstrated that, when hospitals become behemoths in a given market, healthcare costs go up.

“There are robust data showing that consolidation increases healthcare costs by reducing competition, including in oncology,” wrote Dr. Erfani and colleagues.

Oncology practices that are owned by hospitals bill facility fees for outpatient chemotherapy treatment, adding another layer of cost, the researchers explained, citing a 2019 Health Economics study.

Another analysis, published in 2020, found that hospital prices for the top 37 infused cancer drugs averaged 86% more per unit than the price charged by physician offices. Hospital outpatient departments charged even more, on average, for drugs — 128% more for nivolumab and 428% more for fluorouracil, for instance.

In their 2024 analysis, Dr. Erfani and colleagues also found that increased hospital market concentration was associated with worse quality of care, across all assessed patient satisfaction measures, and may result in worse access to care as well.

Overall, these consolidation “trends have important implications for cancer care cost, quality, and access,” the authors concluded.
 

Navigating the Consolidation Trend

In the face of mounting pressure to join hospitals, community oncology practices have typically relied on horizontal mergers to maintain their independence. An increasing number of practices, however, are now turning to another strategy: Management services organizations.

According to some oncologists, a core benefit of joining a management services organization is their community practices can maintain autonomy, hold on to referrals, and benefit from access to a wider network of peers and recently approved treatments such as chimeric antigen receptor T-cell therapies.

In these arrangements, the management company also provides business assistance to practices, including help with billing and collection, payer negotiations, supply chain issues, and credentialing, as well as recruiting, hiring, and marketing.

These management organizations, which include American Oncology Network, Integrated Oncology Network, OneOncology, and Verdi Oncology, are, however, backed by private equity. According to a 2022 report, private equity–backed management organizations have ramped up arrangements with community oncology practices over the past few years — a trend that has concerned some experts.

The authors of a recent analysis in JAMA Internal Medicine explained that, although private equity involvement in physician practices may enable operational efficiencies, “critics point to potential conflicts of interest” and highlight concerns that patients “may face additional barriers to both accessibility and affordability of care.”

The difference, according to some oncologists, is their practices are not owned by the management services organization; instead, the practices enter contracts that outline the boundaries of the relationship and stipulate fees to the management organizations.

In 2020, Dr. Chasky’s practice, Alliance Cancer Specialists, joined The US Oncology Network, a management services organization wholly owned by McKesson. The organization provides the practice with capital and other resources, as well as access to the Sarah Cannon Research Institute, so patients can participate in clinical trials.

“We totally function as an independent practice,” said Dr. Chasky. “We make our own management decisions,” he said. For instance, if Alliance wants to hire a new clinician, US Oncology helps with the recruitment. “But at the end of the day, it’s our practice,” he said.

Davey Daniel, MD — whose community practice joined the management services organization OneOncology — has seen the benefits of being part of a larger network. For instance, bispecific therapies for leukemias, lymphomas, and multiple myeloma are typically administered at academic centers because of the risk for cytokine release syndrome.

However, physician leaders in the OneOncology network “came up with a playbook on how to do it safely” in the community setting, said Dr. Daniel. “It meant that we were adopting FDA newly approved therapies in a very short course.”

Being able to draw from a wider pool of expertise has had other advantages. Dr. Daniel can lean on pathologists and research scientists in the network for advice on targeted therapy use. “We’re actually bringing precision medicine expertise to the community,” Dr. Daniel said.

Dr. Chasky and Dr. Eagle, whose practice is also part of OneOncology, said that continuing to work in the community setting has allowed them greater flexibility.

Dr. Eagle explained that New York Cancer & Blood Specialists tries to offer patients an appointment within 2 days of a referral, and it allows walk-in visits.

Dr. Chasky leans into the flexibility by having staff stay late, when needed, to ensure that all patients are seen. “We’re there for our patients at all hours,” Dr. Chasky said, adding that often “you don’t have that flexibility when you work for a big hospital system.”

The bottom line is community oncology can still thrive, said Nick Ferreyros, managing director of COA, “as long as we have a healthy competitive ecosystem where [we] are valued and seen as an important part of our cancer care system.”

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

When he completed his fellowship at Fox Chase Cancer Center in Philadelphia, Moshe Chasky, MD, joined a small five-person practice that rented space from the city’s Jefferson Hospital in Philadelphia. The arrangement seemed to work well for the hospital and the small practice, which remained independent.

Within 10 years, the hospital sought to buy the practice, Alliance Cancer Specialists.

But the oncologists at Alliance did not want to join Jefferson.

The hospital eventually entered into an exclusive agreement with its own medical group to provide inpatient oncology/hematology services at three Jefferson Health–Northeast hospitals and stripped Dr. Chasky and his colleagues of their privileges at those facilities, Medscape Medical News reported last year.

The Alliance story is a familiar one for independent community oncology practices, said Jeff Patton, MD, CEO of OneOncology, a management services organization.

A 2020 report from the Community Oncology Alliance (COA), for instance, tracked mergers, acquisitions, and closures in the community oncology setting and found the number of practices acquired by hospitals, known as vertical integration, nearly tripled from 2010 to 2020.

“Some hospitals are pretty predatory in their approach,” Dr. Patton said. If hospitals have their own oncology program, “they’ll employ the referring doctors and then discourage them or prevent them from referring patients to our independent practices that are not owned by the hospital.”

Still, in the face of growing pressure to join hospitals, some community oncology practices are finding ways to survive and maintain their independence.
 

A Growing Trend

The latest data continue to show a clear trend: Consolidation in oncology is on the rise.

A 2024 study revealed that the pace of consolidation seems to be increasing.

The analysis found that, between 2015 and 2022, the number of medical oncologists increased by 14% and the number of medical oncologists per practice increased by 40%, while the number of practices decreased by 18%.

While about 44% of practices remain independent, the percentage of medical oncologists working in practices with more than 25 clinicians has increased from 34% in 2015 to 44% in 2022. By 2022, the largest 102 practices in the United States employed more than 40% of all medical oncologists.

“The rate of consolidation seems to be rapid,” study coauthor Parsa Erfani, MD, an internal medicine resident at Brigham & Women’s Hospital, Boston, explained.

Consolidation appears to breed more consolidation. The researchers found, for instance, that markets with greater hospital consolidation and more hospital beds per capita were more likely to undergo consolidation in oncology.

Consolidation may be higher in these markets “because hospitals or health systems are buying up oncology practices or conversely because oncology practices are merging to compete more effectively with larger hospitals in the area,” Dr. Erfani told this news organization.

Mergers among independent practices, known as horizontal integration, have also been on the rise, according to the 2020 COA report. These mergers can help counter pressures from hospitals seeking to acquire community practices as well as prevent practices and their clinics from closing.

Although Dr. Erfani’s research wasn’t designed to determine the factors behind consolidation, he and his colleagues point to the Affordable Care Act (ACA) and the federal 340B Drug Pricing Program as potential drivers of this trend.

The ACA encouraged consolidation as a way to improve efficiency and created the need for ever-larger information systems to collect and report quality data. But these data collection and reporting requirements have become increasingly difficult for smaller practices to take on.

The 340B Program, however, may be a bigger contributing factor to consolidation. Created in 1992, the 340B Program allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy outpatient prescription drugs at a 25%-50% discount.

Hospitals seeking to capitalize on the margins possible under the 340B Program will “buy all the referring physicians in a market so that the medical oncology group is left with little choice but to sell to the hospital,” said Dr. Patton.

“Those 340B dollars are worth a lot to hospitals,” said David A. Eagle, MD, a hematologist/oncologist with New York Cancer & Blood Specialists and past president of COA. The program “creates an appetite for nonprofit hospitals to want to grow their medical oncology programs,” he told this news organization.

Declining Medicare reimbursement has also hit independent practices hard.

Over the past 15 years, compared with inflation, physicians have gotten “a pay rate decrease from Medicare,” said Dr. Patton. Payers have followed that lead and tried to cut pay for clinicians, especially those who do not have market share, he said. Paying them less is “disingenuous knowing that our costs of providing care are going up,” he said.
 

Less Access, Higher Costs, Worse Care?

Many studies have demonstrated that, when hospitals become behemoths in a given market, healthcare costs go up.

“There are robust data showing that consolidation increases healthcare costs by reducing competition, including in oncology,” wrote Dr. Erfani and colleagues.

Oncology practices that are owned by hospitals bill facility fees for outpatient chemotherapy treatment, adding another layer of cost, the researchers explained, citing a 2019 Health Economics study.

Another analysis, published in 2020, found that hospital prices for the top 37 infused cancer drugs averaged 86% more per unit than the price charged by physician offices. Hospital outpatient departments charged even more, on average, for drugs — 128% more for nivolumab and 428% more for fluorouracil, for instance.

In their 2024 analysis, Dr. Erfani and colleagues also found that increased hospital market concentration was associated with worse quality of care, across all assessed patient satisfaction measures, and may result in worse access to care as well.

Overall, these consolidation “trends have important implications for cancer care cost, quality, and access,” the authors concluded.
 

Navigating the Consolidation Trend

In the face of mounting pressure to join hospitals, community oncology practices have typically relied on horizontal mergers to maintain their independence. An increasing number of practices, however, are now turning to another strategy: Management services organizations.

According to some oncologists, a core benefit of joining a management services organization is their community practices can maintain autonomy, hold on to referrals, and benefit from access to a wider network of peers and recently approved treatments such as chimeric antigen receptor T-cell therapies.

In these arrangements, the management company also provides business assistance to practices, including help with billing and collection, payer negotiations, supply chain issues, and credentialing, as well as recruiting, hiring, and marketing.

These management organizations, which include American Oncology Network, Integrated Oncology Network, OneOncology, and Verdi Oncology, are, however, backed by private equity. According to a 2022 report, private equity–backed management organizations have ramped up arrangements with community oncology practices over the past few years — a trend that has concerned some experts.

The authors of a recent analysis in JAMA Internal Medicine explained that, although private equity involvement in physician practices may enable operational efficiencies, “critics point to potential conflicts of interest” and highlight concerns that patients “may face additional barriers to both accessibility and affordability of care.”

The difference, according to some oncologists, is their practices are not owned by the management services organization; instead, the practices enter contracts that outline the boundaries of the relationship and stipulate fees to the management organizations.

In 2020, Dr. Chasky’s practice, Alliance Cancer Specialists, joined The US Oncology Network, a management services organization wholly owned by McKesson. The organization provides the practice with capital and other resources, as well as access to the Sarah Cannon Research Institute, so patients can participate in clinical trials.

“We totally function as an independent practice,” said Dr. Chasky. “We make our own management decisions,” he said. For instance, if Alliance wants to hire a new clinician, US Oncology helps with the recruitment. “But at the end of the day, it’s our practice,” he said.

Davey Daniel, MD — whose community practice joined the management services organization OneOncology — has seen the benefits of being part of a larger network. For instance, bispecific therapies for leukemias, lymphomas, and multiple myeloma are typically administered at academic centers because of the risk for cytokine release syndrome.

However, physician leaders in the OneOncology network “came up with a playbook on how to do it safely” in the community setting, said Dr. Daniel. “It meant that we were adopting FDA newly approved therapies in a very short course.”

Being able to draw from a wider pool of expertise has had other advantages. Dr. Daniel can lean on pathologists and research scientists in the network for advice on targeted therapy use. “We’re actually bringing precision medicine expertise to the community,” Dr. Daniel said.

Dr. Chasky and Dr. Eagle, whose practice is also part of OneOncology, said that continuing to work in the community setting has allowed them greater flexibility.

Dr. Eagle explained that New York Cancer & Blood Specialists tries to offer patients an appointment within 2 days of a referral, and it allows walk-in visits.

Dr. Chasky leans into the flexibility by having staff stay late, when needed, to ensure that all patients are seen. “We’re there for our patients at all hours,” Dr. Chasky said, adding that often “you don’t have that flexibility when you work for a big hospital system.”

The bottom line is community oncology can still thrive, said Nick Ferreyros, managing director of COA, “as long as we have a healthy competitive ecosystem where [we] are valued and seen as an important part of our cancer care system.”

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

ORLANDO, FLA. — The diabetes and weight loss drug tirzepatide (Mounjaro for type 2 diabetes; Zepbound for obesity) was so effective at reducing sleep disruptions in patients with obesity and obstructive sleep apnea (OSA) that 40%-50% no longer needed to use a continuous positive airway pressure (CPAP) device, according to two new studies.

Tirzepatide, a long-acting glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and glucagon-like peptide 1 (GLP-1) receptor agonist, also lowered C-reactive protein levels and systolic blood pressure. And patients taking the medication lost 18%-20% of their body weight. 

The SURMOUNT-OSA studies “mark a significant milestone in the treatment of OSA, offering a promising new therapeutic option that addresses both respiratory and metabolic complications,” said lead author Atul Malhotra, MD, professor of medicine at the University of California, San Diego, and director of sleep medicine at UC San Diego Health. 

The two double-blind, randomized, controlled trials in patients with obesity and moderate to severe OSA were conducted at 60 sites in nine countries. The results were presented at the American Diabetes Association (ADA) 84th Scientific Sessions and simultaneously published online in the New England Journal of Medicine.

OSA affects 1 billion people worldwide and 30 million American adults, many of whom are undiagnosed. Obesity is a common risk factor. According to the ADA, 40% of those with obesity have OSA and 70% of those with OSA have obesity. 

CPAP is an effective and the most-used intervention for OSA, but many patients refuse to use the device, stop using it, or cannot use it. Should tirzepatide eventually gain Food and Drug Administration approval for OSA, it would be the first drug approved for the condition.

“This new drug treatment offers a more accessible alternative for individuals who cannot tolerate or adhere to existing therapies,” said Dr. Malhotra.
 

Huge Reduction in Episodes, Severity

For the two studies, patients were enrolled who had moderate to severe OSA, defined as more than 15 events per hour (using the apnea-hypopnea index [AHI]) and a body mass index of 30 kg/m² or greater. Those not using a CPAP device were enrolled in study 1, and those using a CPAP device were enrolled in study 2. 

Participants received either the maximum tolerated dose of tirzepatide (10 or 15 mg by once-weekly injection) or placebo for 1 year. In study 1, 114 individuals received tirzepatide and 120 received placebo. For study 2, 119 patients received tirzepatide and 114 received placebo. All participants received regular lifestyle counseling sessions about nutrition and were instructed to reduce food intake by 500 kcal/day and to engage in at least 150 min/week of physical activity.

Enrollment was limited to 70% men to ensure adequate representation of women.

At baseline, 65%-70% of participants had severe OSA, with more than 30 events/hour on the AHI scale and a mean of 51.5 events/hour.

By 1 year, patients taking tirzepatide had 27-30 fewer events/hour, compared with 4-6 fewer events/hour for those taking placebo.

Up to half of those who received tirzepatide in both trials had less than 5 events/hour or 5-14 AHI events/hour and an Epworth Sleepiness Scale score of 10 or less. Those thresholds “represent a level at which CPAP therapy may not be recommended,” wrote the authors.

Patients in the tirzepatide group also had a decrease in systolic blood pressure from baseline of 9.7 mm Hg in study 1 and 7.6 mm Hg in study 2 at week 48.

The most common adverse events were diarrhea, nausea, and vomiting, which occurred in approximately a quarter of patients taking tirzepatide. There were two adjudicated-confirmed cases of acute pancreatitis in those taking tirzepatide in study 2. 

Patients who received tirzepatide also reported fewer daytime and nighttime disturbances, as measured using the Patient-Reported Outcomes Measurement Information System Short Form scale for Sleep-Related Impairment and Sleep Disturbance.
 

Tirzepatide Plus CPAP Are Best

Writing in an accompanying editorial, Sanjay R. Patel, MD, noted that, although clinical guidelines have recommended that weight loss strategies be incorporated as part of OSA treatment, “the integration of obesity management into the approaches to care for obstructive sleep apnea has lagged.”

As many as half of patients abandon CPAP therapy within 3 years, wrote Dr. Patel, who is professor of medicine and epidemiology at the University of Pittsburgh, Pittsburgh, Pennsylvania, and medical director of the UPMC Comprehensive Sleep Disorders program. “An effective medication to treat obesity is thus an obvious avenue to pursue.”

Dr. Patel noted the large reductions in the number of events on the AHI scale. He wrote that the improvement in systolic blood pressure “was substantially larger than effects seen with CPAP therapy alone and indicate that tirzepatide may be an attractive option for those patients who seek to reduce their cardiovascular risk.”

Dr. Patel raised concerns about whether patients outside of a trial would stick with therapy, noting studies have shown high rates of discontinuation of GLP-1 receptor agonists.

And, he wrote, “racial disparities in the use of GLP-1 receptor agonists among patients with diabetes arouse concern that the addition of tirzepatide as a treatment option for obstructive sleep apnea without directly addressing policies relative to coverage of care will only further exacerbate already pervasive disparities in clinical care for obstructive sleep apnea.”

Commenting on the study during the presentation of the results, Louis Aronne, MD, said he believes the trials demonstrate “the treatment of obesity with tirzepatide plus CPAP is really the optimal treatment for obstructive sleep apnea and obesity-related cardiometabolic risks.” Dr. Aronne is the Sanford I. Weill professor of metabolic research at Weill Cornell Medical College, New York City.

Dr. Aronne added there is still much to learn. It is still not clear whether tirzepatide had an independent effect in the OSA trial — as has been seen in other studies where the drug clearly reduced cardiovascular risk — or whether the positive results were primarily caused by weight loss.

“I believe that over time we’ll see that this particular effect in sleep apnea is related to weight,” he said. 

The study was supported by Eli Lilly. Dr. Malhotra has reported being a paid consultant for Lilly and ZOLL Medical and a cofounder of Healcisio. 

A version of this article appeared on Medscape.com.
 

ORLANDO, FLA. — The diabetes and weight loss drug tirzepatide (Mounjaro for type 2 diabetes; Zepbound for obesity) was so effective at reducing sleep disruptions in patients with obesity and obstructive sleep apnea (OSA) that 40%-50% no longer needed to use a continuous positive airway pressure (CPAP) device, according to two new studies.

Tirzepatide, a long-acting glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and glucagon-like peptide 1 (GLP-1) receptor agonist, also lowered C-reactive protein levels and systolic blood pressure. And patients taking the medication lost 18%-20% of their body weight. 

The SURMOUNT-OSA studies “mark a significant milestone in the treatment of OSA, offering a promising new therapeutic option that addresses both respiratory and metabolic complications,” said lead author Atul Malhotra, MD, professor of medicine at the University of California, San Diego, and director of sleep medicine at UC San Diego Health. 

The two double-blind, randomized, controlled trials in patients with obesity and moderate to severe OSA were conducted at 60 sites in nine countries. The results were presented at the American Diabetes Association (ADA) 84th Scientific Sessions and simultaneously published online in the New England Journal of Medicine.

OSA affects 1 billion people worldwide and 30 million American adults, many of whom are undiagnosed. Obesity is a common risk factor. According to the ADA, 40% of those with obesity have OSA and 70% of those with OSA have obesity. 

CPAP is an effective and the most-used intervention for OSA, but many patients refuse to use the device, stop using it, or cannot use it. Should tirzepatide eventually gain Food and Drug Administration approval for OSA, it would be the first drug approved for the condition.

“This new drug treatment offers a more accessible alternative for individuals who cannot tolerate or adhere to existing therapies,” said Dr. Malhotra.
 

Huge Reduction in Episodes, Severity

For the two studies, patients were enrolled who had moderate to severe OSA, defined as more than 15 events per hour (using the apnea-hypopnea index [AHI]) and a body mass index of 30 kg/m² or greater. Those not using a CPAP device were enrolled in study 1, and those using a CPAP device were enrolled in study 2. 

Participants received either the maximum tolerated dose of tirzepatide (10 or 15 mg by once-weekly injection) or placebo for 1 year. In study 1, 114 individuals received tirzepatide and 120 received placebo. For study 2, 119 patients received tirzepatide and 114 received placebo. All participants received regular lifestyle counseling sessions about nutrition and were instructed to reduce food intake by 500 kcal/day and to engage in at least 150 min/week of physical activity.

Enrollment was limited to 70% men to ensure adequate representation of women.

At baseline, 65%-70% of participants had severe OSA, with more than 30 events/hour on the AHI scale and a mean of 51.5 events/hour.

By 1 year, patients taking tirzepatide had 27-30 fewer events/hour, compared with 4-6 fewer events/hour for those taking placebo.

Up to half of those who received tirzepatide in both trials had less than 5 events/hour or 5-14 AHI events/hour and an Epworth Sleepiness Scale score of 10 or less. Those thresholds “represent a level at which CPAP therapy may not be recommended,” wrote the authors.

Patients in the tirzepatide group also had a decrease in systolic blood pressure from baseline of 9.7 mm Hg in study 1 and 7.6 mm Hg in study 2 at week 48.

The most common adverse events were diarrhea, nausea, and vomiting, which occurred in approximately a quarter of patients taking tirzepatide. There were two adjudicated-confirmed cases of acute pancreatitis in those taking tirzepatide in study 2. 

Patients who received tirzepatide also reported fewer daytime and nighttime disturbances, as measured using the Patient-Reported Outcomes Measurement Information System Short Form scale for Sleep-Related Impairment and Sleep Disturbance.
 

Tirzepatide Plus CPAP Are Best

Writing in an accompanying editorial, Sanjay R. Patel, MD, noted that, although clinical guidelines have recommended that weight loss strategies be incorporated as part of OSA treatment, “the integration of obesity management into the approaches to care for obstructive sleep apnea has lagged.”

As many as half of patients abandon CPAP therapy within 3 years, wrote Dr. Patel, who is professor of medicine and epidemiology at the University of Pittsburgh, Pittsburgh, Pennsylvania, and medical director of the UPMC Comprehensive Sleep Disorders program. “An effective medication to treat obesity is thus an obvious avenue to pursue.”

Dr. Patel noted the large reductions in the number of events on the AHI scale. He wrote that the improvement in systolic blood pressure “was substantially larger than effects seen with CPAP therapy alone and indicate that tirzepatide may be an attractive option for those patients who seek to reduce their cardiovascular risk.”

Dr. Patel raised concerns about whether patients outside of a trial would stick with therapy, noting studies have shown high rates of discontinuation of GLP-1 receptor agonists.

And, he wrote, “racial disparities in the use of GLP-1 receptor agonists among patients with diabetes arouse concern that the addition of tirzepatide as a treatment option for obstructive sleep apnea without directly addressing policies relative to coverage of care will only further exacerbate already pervasive disparities in clinical care for obstructive sleep apnea.”

Commenting on the study during the presentation of the results, Louis Aronne, MD, said he believes the trials demonstrate “the treatment of obesity with tirzepatide plus CPAP is really the optimal treatment for obstructive sleep apnea and obesity-related cardiometabolic risks.” Dr. Aronne is the Sanford I. Weill professor of metabolic research at Weill Cornell Medical College, New York City.

Dr. Aronne added there is still much to learn. It is still not clear whether tirzepatide had an independent effect in the OSA trial — as has been seen in other studies where the drug clearly reduced cardiovascular risk — or whether the positive results were primarily caused by weight loss.

“I believe that over time we’ll see that this particular effect in sleep apnea is related to weight,” he said. 

The study was supported by Eli Lilly. Dr. Malhotra has reported being a paid consultant for Lilly and ZOLL Medical and a cofounder of Healcisio. 

A version of this article appeared on Medscape.com.
 

ORLANDO, FLA. — The diabetes and weight loss drug tirzepatide (Mounjaro for type 2 diabetes; Zepbound for obesity) was so effective at reducing sleep disruptions in patients with obesity and obstructive sleep apnea (OSA) that 40%-50% no longer needed to use a continuous positive airway pressure (CPAP) device, according to two new studies.

Tirzepatide, a long-acting glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and glucagon-like peptide 1 (GLP-1) receptor agonist, also lowered C-reactive protein levels and systolic blood pressure. And patients taking the medication lost 18%-20% of their body weight. 

The SURMOUNT-OSA studies “mark a significant milestone in the treatment of OSA, offering a promising new therapeutic option that addresses both respiratory and metabolic complications,” said lead author Atul Malhotra, MD, professor of medicine at the University of California, San Diego, and director of sleep medicine at UC San Diego Health. 

The two double-blind, randomized, controlled trials in patients with obesity and moderate to severe OSA were conducted at 60 sites in nine countries. The results were presented at the American Diabetes Association (ADA) 84th Scientific Sessions and simultaneously published online in the New England Journal of Medicine.

OSA affects 1 billion people worldwide and 30 million American adults, many of whom are undiagnosed. Obesity is a common risk factor. According to the ADA, 40% of those with obesity have OSA and 70% of those with OSA have obesity. 

CPAP is an effective and the most-used intervention for OSA, but many patients refuse to use the device, stop using it, or cannot use it. Should tirzepatide eventually gain Food and Drug Administration approval for OSA, it would be the first drug approved for the condition.

“This new drug treatment offers a more accessible alternative for individuals who cannot tolerate or adhere to existing therapies,” said Dr. Malhotra.
 

Huge Reduction in Episodes, Severity

For the two studies, patients were enrolled who had moderate to severe OSA, defined as more than 15 events per hour (using the apnea-hypopnea index [AHI]) and a body mass index of 30 kg/m² or greater. Those not using a CPAP device were enrolled in study 1, and those using a CPAP device were enrolled in study 2. 

Participants received either the maximum tolerated dose of tirzepatide (10 or 15 mg by once-weekly injection) or placebo for 1 year. In study 1, 114 individuals received tirzepatide and 120 received placebo. For study 2, 119 patients received tirzepatide and 114 received placebo. All participants received regular lifestyle counseling sessions about nutrition and were instructed to reduce food intake by 500 kcal/day and to engage in at least 150 min/week of physical activity.

Enrollment was limited to 70% men to ensure adequate representation of women.

At baseline, 65%-70% of participants had severe OSA, with more than 30 events/hour on the AHI scale and a mean of 51.5 events/hour.

By 1 year, patients taking tirzepatide had 27-30 fewer events/hour, compared with 4-6 fewer events/hour for those taking placebo.

Up to half of those who received tirzepatide in both trials had less than 5 events/hour or 5-14 AHI events/hour and an Epworth Sleepiness Scale score of 10 or less. Those thresholds “represent a level at which CPAP therapy may not be recommended,” wrote the authors.

Patients in the tirzepatide group also had a decrease in systolic blood pressure from baseline of 9.7 mm Hg in study 1 and 7.6 mm Hg in study 2 at week 48.

The most common adverse events were diarrhea, nausea, and vomiting, which occurred in approximately a quarter of patients taking tirzepatide. There were two adjudicated-confirmed cases of acute pancreatitis in those taking tirzepatide in study 2. 

Patients who received tirzepatide also reported fewer daytime and nighttime disturbances, as measured using the Patient-Reported Outcomes Measurement Information System Short Form scale for Sleep-Related Impairment and Sleep Disturbance.
 

Tirzepatide Plus CPAP Are Best

Writing in an accompanying editorial, Sanjay R. Patel, MD, noted that, although clinical guidelines have recommended that weight loss strategies be incorporated as part of OSA treatment, “the integration of obesity management into the approaches to care for obstructive sleep apnea has lagged.”

As many as half of patients abandon CPAP therapy within 3 years, wrote Dr. Patel, who is professor of medicine and epidemiology at the University of Pittsburgh, Pittsburgh, Pennsylvania, and medical director of the UPMC Comprehensive Sleep Disorders program. “An effective medication to treat obesity is thus an obvious avenue to pursue.”

Dr. Patel noted the large reductions in the number of events on the AHI scale. He wrote that the improvement in systolic blood pressure “was substantially larger than effects seen with CPAP therapy alone and indicate that tirzepatide may be an attractive option for those patients who seek to reduce their cardiovascular risk.”

Dr. Patel raised concerns about whether patients outside of a trial would stick with therapy, noting studies have shown high rates of discontinuation of GLP-1 receptor agonists.

And, he wrote, “racial disparities in the use of GLP-1 receptor agonists among patients with diabetes arouse concern that the addition of tirzepatide as a treatment option for obstructive sleep apnea without directly addressing policies relative to coverage of care will only further exacerbate already pervasive disparities in clinical care for obstructive sleep apnea.”

Commenting on the study during the presentation of the results, Louis Aronne, MD, said he believes the trials demonstrate “the treatment of obesity with tirzepatide plus CPAP is really the optimal treatment for obstructive sleep apnea and obesity-related cardiometabolic risks.” Dr. Aronne is the Sanford I. Weill professor of metabolic research at Weill Cornell Medical College, New York City.

Dr. Aronne added there is still much to learn. It is still not clear whether tirzepatide had an independent effect in the OSA trial — as has been seen in other studies where the drug clearly reduced cardiovascular risk — or whether the positive results were primarily caused by weight loss.

“I believe that over time we’ll see that this particular effect in sleep apnea is related to weight,” he said. 

The study was supported by Eli Lilly. Dr. Malhotra has reported being a paid consultant for Lilly and ZOLL Medical and a cofounder of Healcisio. 

A version of this article appeared on Medscape.com.
 

A single course of treatment with emotional awareness and expression therapy (EAET) was associated with a significantly greater reduction in chronic pain severity than cognitive-behavioral therapy (CBT), the current psychotherapeutic gold standard, a new study suggested.

Two thirds of the patients who received EAET reported at least a 30% reduction in pain compared with 17% of those who received CBT. The randomized clinical trial also showed that individuals with depression and anxiety responded more favorably to EAET, a novel finding.

The study is one of only a few to directly compare EAET with CBT.

“Most people with chronic pain don’t consider psychotherapy at all,” said study investigator Brandon C. Yarns, MD, a staff psychiatrist at the VA Greater Los Angeles Healthcare System, and clinical professor of health sciences at the Department of Psychiatry and Biobehavioral Sciences, UCLA Health.

Although patients were allowed to continue medication for pain and other comorbidities during the study, those who received EAET “had larger improvements in pain, depression, and anxiety,” Dr. Yarns said. “That suggests that the effect was due to the EAET.”

The findings were published online in JAMA Network Open.
 

‘Gold Standard’

EAET was first used in the early 2010s. In the therapy, patients are asked to recall a difficult or traumatic memory, engage in experiencing how the related emotions feel in the body, express those feelings in words, and release or let them go. They are taught that the brain’s perception of pain is strongly influenced by the evasion of grief, fear, rage, or guilt, Dr. Yarns said.

This contrasts with CBT — considered the current gold standard for chronic pain — which teaches patients to improve the ability to tolerate pain though guided imagery, muscle relaxation, and other exercises and to adapt their thinking to change how they think about pain.

Although prior studies suggested EAET is effective in reducing pain in fibromyalgia and chronic musculoskeletal, pelvic, and head pain, most included primarily younger, female patients.

The research is the “first full-scale evaluation of EAET, to our knowledge, in a medically or psychiatrically complex, racially and ethnically diverse, older sample comprising predominantly men,” investigators wrote.

The trial enrolled 126 veterans (92% men; 55% Black or African American) aged 60-95 years with at least 3 months of musculoskeletal pain. More than two thirds of patients had a psychiatric diagnosis, with about one third having posttraumatic stress disorder (PTSD). Almost all had back pain, and many had pain in multiple locations.

All services were delivered in-person at the US Department of Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles. Half underwent CBT, while the other half received EAET.

Each patient had one 90-minute individual session and eight additional 90-minute group sessions.

Patients were asked to rate their pain using a 0-10 scale in the Brief Pain Inventory (BPI) before starting treatment, at the end of the nine sessions (at week 10), and 6 months after the sessions ended. Baseline BPI score for both groups was a mean of around 6.

Post treatment, people in the EAET versus CBT group had a mean two-point reduction versus 0.60 reduction, respectively, on the BPI scale. A clinically significant reduction in pain — defined as ≥ 30% decrease — was reported in 63% of EAET patients versus 17% of CBT patients (odds ratio [OR], 21.54; P < .001).

At 6 months, the mean reduction was 1.2 for the EAET group compared with 0.25 for the CBT group, and 40% of the EAET group reported a clinically significant reduction in pain.

A little more than a third (35%) of veterans receiving EAET reported at least a 50% reduction in pain at 10 weeks compared with 7% of those receiving CBT. At 6 months, 16% of the EAET arm reported a halving of their pain.

EAET was also superior to CBT in reducing anxiety, depression, and PTSD symptoms at the 10-week mark.
 

More Work Needed

In an accompanying editorial, Matthias Karst, MD, PhD, a clinician with the Pain Clinic, Hannover Medical School, in Hannover, Germany, noted that EAET’s effects “are significantly superior to those of CBT in almost all dimensions, even after 6 months.”

EAET “assigns a special place to the integration of the body into the emotional experience,” he wrote.

The study demonstrated that “the evocation and expression of emotions is superior to the mere cognitive discussion of these emotions in therapy of patients with chronic pain.”

Commenting on the findings, Traci J. Speed, MD, PhD, assistant professor of psychiatry and behavioral sciences and an attending psychiatrist of the Johns Hopkins Pain Treatment Program at Johns Hopkins University, Baltimore, called the study “ground-breaking” because it showed effectiveness in people with high rates of PTSD, anxiety, and depression.

“It is a little bit surprising how impressive the study outcomes are in terms of maintaining the effects at the end of the treatment and sustaining some of the effects on pain sensitivity even at the 6-month follow-up,” said Dr. Speed, who was not part of the study.

However, she continued, “I don’t think it changes the current standard of practice yet. CBT has decades of research and evidence that it is effective for chronic pain and that will I think continue to be the standard of care.”

Although EAET is in its infancy, chronic pain experts are interested in learning more about the therapy, Dr. Speed added.

“It blends well with the current techniques and extends the current gold standard treatment approaches,” she said. “We are starting to really appreciate the role that emotions play in pain sensitivity.”

Both Dr. Karst and Dr. Speed noted that more study is needed to determine the sustainability of treatment effects.

Dr. Yarns agreed. “We need more research on what the appropriate dose is and perhaps how one might go about personalizing that for the patient,” he said.

The study was funded by a career development award to Dr. Yarns from the VA Clinical Science Research and Development Service. Dr. Yarns reported receiving grants from the US Department of Veterans Affairs during the study. Other authors’ disclosures are in the original article. Dr. Speed reported no conflicts.
 

A version of this article appeared on Medscape.com.

A single course of treatment with emotional awareness and expression therapy (EAET) was associated with a significantly greater reduction in chronic pain severity than cognitive-behavioral therapy (CBT), the current psychotherapeutic gold standard, a new study suggested.

Two thirds of the patients who received EAET reported at least a 30% reduction in pain compared with 17% of those who received CBT. The randomized clinical trial also showed that individuals with depression and anxiety responded more favorably to EAET, a novel finding.

The study is one of only a few to directly compare EAET with CBT.

“Most people with chronic pain don’t consider psychotherapy at all,” said study investigator Brandon C. Yarns, MD, a staff psychiatrist at the VA Greater Los Angeles Healthcare System, and clinical professor of health sciences at the Department of Psychiatry and Biobehavioral Sciences, UCLA Health.

Although patients were allowed to continue medication for pain and other comorbidities during the study, those who received EAET “had larger improvements in pain, depression, and anxiety,” Dr. Yarns said. “That suggests that the effect was due to the EAET.”

The findings were published online in JAMA Network Open.
 

‘Gold Standard’

EAET was first used in the early 2010s. In the therapy, patients are asked to recall a difficult or traumatic memory, engage in experiencing how the related emotions feel in the body, express those feelings in words, and release or let them go. They are taught that the brain’s perception of pain is strongly influenced by the evasion of grief, fear, rage, or guilt, Dr. Yarns said.

This contrasts with CBT — considered the current gold standard for chronic pain — which teaches patients to improve the ability to tolerate pain though guided imagery, muscle relaxation, and other exercises and to adapt their thinking to change how they think about pain.

Although prior studies suggested EAET is effective in reducing pain in fibromyalgia and chronic musculoskeletal, pelvic, and head pain, most included primarily younger, female patients.

The research is the “first full-scale evaluation of EAET, to our knowledge, in a medically or psychiatrically complex, racially and ethnically diverse, older sample comprising predominantly men,” investigators wrote.

The trial enrolled 126 veterans (92% men; 55% Black or African American) aged 60-95 years with at least 3 months of musculoskeletal pain. More than two thirds of patients had a psychiatric diagnosis, with about one third having posttraumatic stress disorder (PTSD). Almost all had back pain, and many had pain in multiple locations.

All services were delivered in-person at the US Department of Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles. Half underwent CBT, while the other half received EAET.

Each patient had one 90-minute individual session and eight additional 90-minute group sessions.

Patients were asked to rate their pain using a 0-10 scale in the Brief Pain Inventory (BPI) before starting treatment, at the end of the nine sessions (at week 10), and 6 months after the sessions ended. Baseline BPI score for both groups was a mean of around 6.

Post treatment, people in the EAET versus CBT group had a mean two-point reduction versus 0.60 reduction, respectively, on the BPI scale. A clinically significant reduction in pain — defined as ≥ 30% decrease — was reported in 63% of EAET patients versus 17% of CBT patients (odds ratio [OR], 21.54; P < .001).

At 6 months, the mean reduction was 1.2 for the EAET group compared with 0.25 for the CBT group, and 40% of the EAET group reported a clinically significant reduction in pain.

A little more than a third (35%) of veterans receiving EAET reported at least a 50% reduction in pain at 10 weeks compared with 7% of those receiving CBT. At 6 months, 16% of the EAET arm reported a halving of their pain.

EAET was also superior to CBT in reducing anxiety, depression, and PTSD symptoms at the 10-week mark.
 

More Work Needed

In an accompanying editorial, Matthias Karst, MD, PhD, a clinician with the Pain Clinic, Hannover Medical School, in Hannover, Germany, noted that EAET’s effects “are significantly superior to those of CBT in almost all dimensions, even after 6 months.”

EAET “assigns a special place to the integration of the body into the emotional experience,” he wrote.

The study demonstrated that “the evocation and expression of emotions is superior to the mere cognitive discussion of these emotions in therapy of patients with chronic pain.”

Commenting on the findings, Traci J. Speed, MD, PhD, assistant professor of psychiatry and behavioral sciences and an attending psychiatrist of the Johns Hopkins Pain Treatment Program at Johns Hopkins University, Baltimore, called the study “ground-breaking” because it showed effectiveness in people with high rates of PTSD, anxiety, and depression.

“It is a little bit surprising how impressive the study outcomes are in terms of maintaining the effects at the end of the treatment and sustaining some of the effects on pain sensitivity even at the 6-month follow-up,” said Dr. Speed, who was not part of the study.

However, she continued, “I don’t think it changes the current standard of practice yet. CBT has decades of research and evidence that it is effective for chronic pain and that will I think continue to be the standard of care.”

Although EAET is in its infancy, chronic pain experts are interested in learning more about the therapy, Dr. Speed added.

“It blends well with the current techniques and extends the current gold standard treatment approaches,” she said. “We are starting to really appreciate the role that emotions play in pain sensitivity.”

Both Dr. Karst and Dr. Speed noted that more study is needed to determine the sustainability of treatment effects.

Dr. Yarns agreed. “We need more research on what the appropriate dose is and perhaps how one might go about personalizing that for the patient,” he said.

The study was funded by a career development award to Dr. Yarns from the VA Clinical Science Research and Development Service. Dr. Yarns reported receiving grants from the US Department of Veterans Affairs during the study. Other authors’ disclosures are in the original article. Dr. Speed reported no conflicts.
 

A version of this article appeared on Medscape.com.

A single course of treatment with emotional awareness and expression therapy (EAET) was associated with a significantly greater reduction in chronic pain severity than cognitive-behavioral therapy (CBT), the current psychotherapeutic gold standard, a new study suggested.

Two thirds of the patients who received EAET reported at least a 30% reduction in pain compared with 17% of those who received CBT. The randomized clinical trial also showed that individuals with depression and anxiety responded more favorably to EAET, a novel finding.

The study is one of only a few to directly compare EAET with CBT.

“Most people with chronic pain don’t consider psychotherapy at all,” said study investigator Brandon C. Yarns, MD, a staff psychiatrist at the VA Greater Los Angeles Healthcare System, and clinical professor of health sciences at the Department of Psychiatry and Biobehavioral Sciences, UCLA Health.

Although patients were allowed to continue medication for pain and other comorbidities during the study, those who received EAET “had larger improvements in pain, depression, and anxiety,” Dr. Yarns said. “That suggests that the effect was due to the EAET.”

The findings were published online in JAMA Network Open.
 

‘Gold Standard’

EAET was first used in the early 2010s. In the therapy, patients are asked to recall a difficult or traumatic memory, engage in experiencing how the related emotions feel in the body, express those feelings in words, and release or let them go. They are taught that the brain’s perception of pain is strongly influenced by the evasion of grief, fear, rage, or guilt, Dr. Yarns said.

This contrasts with CBT — considered the current gold standard for chronic pain — which teaches patients to improve the ability to tolerate pain though guided imagery, muscle relaxation, and other exercises and to adapt their thinking to change how they think about pain.

Although prior studies suggested EAET is effective in reducing pain in fibromyalgia and chronic musculoskeletal, pelvic, and head pain, most included primarily younger, female patients.

The research is the “first full-scale evaluation of EAET, to our knowledge, in a medically or psychiatrically complex, racially and ethnically diverse, older sample comprising predominantly men,” investigators wrote.

The trial enrolled 126 veterans (92% men; 55% Black or African American) aged 60-95 years with at least 3 months of musculoskeletal pain. More than two thirds of patients had a psychiatric diagnosis, with about one third having posttraumatic stress disorder (PTSD). Almost all had back pain, and many had pain in multiple locations.

All services were delivered in-person at the US Department of Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles. Half underwent CBT, while the other half received EAET.

Each patient had one 90-minute individual session and eight additional 90-minute group sessions.

Patients were asked to rate their pain using a 0-10 scale in the Brief Pain Inventory (BPI) before starting treatment, at the end of the nine sessions (at week 10), and 6 months after the sessions ended. Baseline BPI score for both groups was a mean of around 6.

Post treatment, people in the EAET versus CBT group had a mean two-point reduction versus 0.60 reduction, respectively, on the BPI scale. A clinically significant reduction in pain — defined as ≥ 30% decrease — was reported in 63% of EAET patients versus 17% of CBT patients (odds ratio [OR], 21.54; P < .001).

At 6 months, the mean reduction was 1.2 for the EAET group compared with 0.25 for the CBT group, and 40% of the EAET group reported a clinically significant reduction in pain.

A little more than a third (35%) of veterans receiving EAET reported at least a 50% reduction in pain at 10 weeks compared with 7% of those receiving CBT. At 6 months, 16% of the EAET arm reported a halving of their pain.

EAET was also superior to CBT in reducing anxiety, depression, and PTSD symptoms at the 10-week mark.
 

More Work Needed

In an accompanying editorial, Matthias Karst, MD, PhD, a clinician with the Pain Clinic, Hannover Medical School, in Hannover, Germany, noted that EAET’s effects “are significantly superior to those of CBT in almost all dimensions, even after 6 months.”

EAET “assigns a special place to the integration of the body into the emotional experience,” he wrote.

The study demonstrated that “the evocation and expression of emotions is superior to the mere cognitive discussion of these emotions in therapy of patients with chronic pain.”

Commenting on the findings, Traci J. Speed, MD, PhD, assistant professor of psychiatry and behavioral sciences and an attending psychiatrist of the Johns Hopkins Pain Treatment Program at Johns Hopkins University, Baltimore, called the study “ground-breaking” because it showed effectiveness in people with high rates of PTSD, anxiety, and depression.

“It is a little bit surprising how impressive the study outcomes are in terms of maintaining the effects at the end of the treatment and sustaining some of the effects on pain sensitivity even at the 6-month follow-up,” said Dr. Speed, who was not part of the study.

However, she continued, “I don’t think it changes the current standard of practice yet. CBT has decades of research and evidence that it is effective for chronic pain and that will I think continue to be the standard of care.”

Although EAET is in its infancy, chronic pain experts are interested in learning more about the therapy, Dr. Speed added.

“It blends well with the current techniques and extends the current gold standard treatment approaches,” she said. “We are starting to really appreciate the role that emotions play in pain sensitivity.”

Both Dr. Karst and Dr. Speed noted that more study is needed to determine the sustainability of treatment effects.

Dr. Yarns agreed. “We need more research on what the appropriate dose is and perhaps how one might go about personalizing that for the patient,” he said.

The study was funded by a career development award to Dr. Yarns from the VA Clinical Science Research and Development Service. Dr. Yarns reported receiving grants from the US Department of Veterans Affairs during the study. Other authors’ disclosures are in the original article. Dr. Speed reported no conflicts.
 

A version of this article appeared on Medscape.com.

Nearly one in three physicians endorsing drugs and devices on the social media platform X did not disclose that they received payments from the manufacturers, according to a new study published in JAMA.

Lead author Aaron Mitchell, MD, MPH, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, told this news organization that he and his colleagues undertook the study in part to see whether physicians were adhering to professional and industry guidelines regarding marketing communications.

The team reviewed posts by physicians on X during 2022, looking for key words that might indicate that the posts were intended as endorsements of a product. The researchers then delved into the Centers for Medicare and Medicaid Services Open Payments database to see how many of those identified as having endorsed a product were paid by the manufacturers.

What Dr. Mitchell found concerned him, he said.

Overall, the researchers identified 28 physician endorsers who received a total of $1.4 million from sponsors in 2022. Among these, 26 physicians (93%) received payments from the product’s manufacturer, totaling $713,976, and 24 physicians (86%) accepted payments related to the endorsed drug or device, totaling $492,098.

While most did disclose that the posts were sponsored — by adding the word “sponsored” or using #sponsored — nine physicians did not.

Although 28 physician endorsers represent a “small fraction” of the overall number of physicians who use X, each endorsement was ultimately posted dozens, if not hundreds of times, said Dr. Mitchell. In fact, he said he saw the same particular endorsement post every time he opened his X app for months.

Overall, Dr. Mitchell noted that it’s less about the fact that the endorsements are occurring on social media and more that there are these paid endorsements taking place at all.

Among the physician specialties promoting a product, urologists and oncologists dominated. Almost one third were urologists, and 57% were oncologists — six medical oncologists, six radiation oncologists, and four gynecologic oncologists. Of the remaining three physicians, two were internists and one was a pulmonary and critical care medicine specialist.

The authors tracked posts from physicians and industry accounts. Many of the posts on industry accounts were physician testimonials, usually videos. Almost half — 8 of 17 — of those testimonials did not disclose that the doctor was being paid by the manufacturer. In another case, a physician did not disclose that they were paid to endorse a white paper.

Fifteen promotional posts were for a Boston Scientific product, followed by six for GlaxoSmithKline, two for Eisai, two for Exelixis, and one each for AstraZeneca, Novartis, and Pfizer.

In general, Dr. Mitchell said, industry guidelines suggest that manufacturer-paid speakers or consultants should have well-regarded expertise in the area they are being asked to weigh in on, but most physician endorsers in the study were not key opinion leaders or experts.

The authors examined the paid endorsers’ H-index — a measure of academic productivity provided by Scopus. Overall, 19 of the 28 physicians had an H-index below 20, which is considered less accomplished, and 14 had no published research related to the endorsed product.

Ten received payments from manufacturers for research purposes, and only one received research payments related to the endorsed product ($224,577).

“Physicians’ participation in industry marketing raises questions regarding professionalism and their responsibilities as patient advocates,” the JAMA authors wrote.

The study was supported by grants from the National Cancer Institute. Dr. Mitchell reported no relevant financial relationships. Coauthors Samer Al Hadidi, MD, reported receiving personal fees from Pfizer, Sanofi, and Janssen during the conduct of the study, and Timothy S. Anderson, MD, reported receiving grants from the National Institute on Aging, the American Heart Association, and the American College of Cardiology, and receiving consulting fees from the American Medical Student Association. Dr. Anderson is also an associate editor of JAMA Internal Medicine.

A version of this article appeared on Medscape.com.

Nearly one in three physicians endorsing drugs and devices on the social media platform X did not disclose that they received payments from the manufacturers, according to a new study published in JAMA.

Lead author Aaron Mitchell, MD, MPH, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, told this news organization that he and his colleagues undertook the study in part to see whether physicians were adhering to professional and industry guidelines regarding marketing communications.

The team reviewed posts by physicians on X during 2022, looking for key words that might indicate that the posts were intended as endorsements of a product. The researchers then delved into the Centers for Medicare and Medicaid Services Open Payments database to see how many of those identified as having endorsed a product were paid by the manufacturers.

What Dr. Mitchell found concerned him, he said.

Overall, the researchers identified 28 physician endorsers who received a total of $1.4 million from sponsors in 2022. Among these, 26 physicians (93%) received payments from the product’s manufacturer, totaling $713,976, and 24 physicians (86%) accepted payments related to the endorsed drug or device, totaling $492,098.

While most did disclose that the posts were sponsored — by adding the word “sponsored” or using #sponsored — nine physicians did not.

Although 28 physician endorsers represent a “small fraction” of the overall number of physicians who use X, each endorsement was ultimately posted dozens, if not hundreds of times, said Dr. Mitchell. In fact, he said he saw the same particular endorsement post every time he opened his X app for months.

Overall, Dr. Mitchell noted that it’s less about the fact that the endorsements are occurring on social media and more that there are these paid endorsements taking place at all.

Among the physician specialties promoting a product, urologists and oncologists dominated. Almost one third were urologists, and 57% were oncologists — six medical oncologists, six radiation oncologists, and four gynecologic oncologists. Of the remaining three physicians, two were internists and one was a pulmonary and critical care medicine specialist.

The authors tracked posts from physicians and industry accounts. Many of the posts on industry accounts were physician testimonials, usually videos. Almost half — 8 of 17 — of those testimonials did not disclose that the doctor was being paid by the manufacturer. In another case, a physician did not disclose that they were paid to endorse a white paper.

Fifteen promotional posts were for a Boston Scientific product, followed by six for GlaxoSmithKline, two for Eisai, two for Exelixis, and one each for AstraZeneca, Novartis, and Pfizer.

In general, Dr. Mitchell said, industry guidelines suggest that manufacturer-paid speakers or consultants should have well-regarded expertise in the area they are being asked to weigh in on, but most physician endorsers in the study were not key opinion leaders or experts.

The authors examined the paid endorsers’ H-index — a measure of academic productivity provided by Scopus. Overall, 19 of the 28 physicians had an H-index below 20, which is considered less accomplished, and 14 had no published research related to the endorsed product.

Ten received payments from manufacturers for research purposes, and only one received research payments related to the endorsed product ($224,577).

“Physicians’ participation in industry marketing raises questions regarding professionalism and their responsibilities as patient advocates,” the JAMA authors wrote.

The study was supported by grants from the National Cancer Institute. Dr. Mitchell reported no relevant financial relationships. Coauthors Samer Al Hadidi, MD, reported receiving personal fees from Pfizer, Sanofi, and Janssen during the conduct of the study, and Timothy S. Anderson, MD, reported receiving grants from the National Institute on Aging, the American Heart Association, and the American College of Cardiology, and receiving consulting fees from the American Medical Student Association. Dr. Anderson is also an associate editor of JAMA Internal Medicine.

A version of this article appeared on Medscape.com.

Nearly one in three physicians endorsing drugs and devices on the social media platform X did not disclose that they received payments from the manufacturers, according to a new study published in JAMA.

Lead author Aaron Mitchell, MD, MPH, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, told this news organization that he and his colleagues undertook the study in part to see whether physicians were adhering to professional and industry guidelines regarding marketing communications.

The team reviewed posts by physicians on X during 2022, looking for key words that might indicate that the posts were intended as endorsements of a product. The researchers then delved into the Centers for Medicare and Medicaid Services Open Payments database to see how many of those identified as having endorsed a product were paid by the manufacturers.

What Dr. Mitchell found concerned him, he said.

Overall, the researchers identified 28 physician endorsers who received a total of $1.4 million from sponsors in 2022. Among these, 26 physicians (93%) received payments from the product’s manufacturer, totaling $713,976, and 24 physicians (86%) accepted payments related to the endorsed drug or device, totaling $492,098.

While most did disclose that the posts were sponsored — by adding the word “sponsored” or using #sponsored — nine physicians did not.

Although 28 physician endorsers represent a “small fraction” of the overall number of physicians who use X, each endorsement was ultimately posted dozens, if not hundreds of times, said Dr. Mitchell. In fact, he said he saw the same particular endorsement post every time he opened his X app for months.

Overall, Dr. Mitchell noted that it’s less about the fact that the endorsements are occurring on social media and more that there are these paid endorsements taking place at all.

Among the physician specialties promoting a product, urologists and oncologists dominated. Almost one third were urologists, and 57% were oncologists — six medical oncologists, six radiation oncologists, and four gynecologic oncologists. Of the remaining three physicians, two were internists and one was a pulmonary and critical care medicine specialist.

The authors tracked posts from physicians and industry accounts. Many of the posts on industry accounts were physician testimonials, usually videos. Almost half — 8 of 17 — of those testimonials did not disclose that the doctor was being paid by the manufacturer. In another case, a physician did not disclose that they were paid to endorse a white paper.

Fifteen promotional posts were for a Boston Scientific product, followed by six for GlaxoSmithKline, two for Eisai, two for Exelixis, and one each for AstraZeneca, Novartis, and Pfizer.

In general, Dr. Mitchell said, industry guidelines suggest that manufacturer-paid speakers or consultants should have well-regarded expertise in the area they are being asked to weigh in on, but most physician endorsers in the study were not key opinion leaders or experts.

The authors examined the paid endorsers’ H-index — a measure of academic productivity provided by Scopus. Overall, 19 of the 28 physicians had an H-index below 20, which is considered less accomplished, and 14 had no published research related to the endorsed product.

Ten received payments from manufacturers for research purposes, and only one received research payments related to the endorsed product ($224,577).

“Physicians’ participation in industry marketing raises questions regarding professionalism and their responsibilities as patient advocates,” the JAMA authors wrote.

The study was supported by grants from the National Cancer Institute. Dr. Mitchell reported no relevant financial relationships. Coauthors Samer Al Hadidi, MD, reported receiving personal fees from Pfizer, Sanofi, and Janssen during the conduct of the study, and Timothy S. Anderson, MD, reported receiving grants from the National Institute on Aging, the American Heart Association, and the American College of Cardiology, and receiving consulting fees from the American Medical Student Association. Dr. Anderson is also an associate editor of JAMA Internal Medicine.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved Onyda XR (clonidine hydrochloride) for the treatment of attention-deficit/hyperactivity disorder (ADHD), drug manufacturer Tris Pharma announced in a statement.

The drug is the first approved liquid nonstimulant ADHD medication. The once-daily extended-release oral suspension, with nighttime dosing, can be used alone or as an adjunctive therapy to FDA-approved stimulant medications in pediatric patients 6 years of age or older.

“People with ADHD require a range of therapeutic options that are designed for their individual needs, because not every medication or type of therapy works for every patient,” Ann Childress, MD, a psychiatrist and president of the Las Vegas–based Center for Psychiatry and Behavioral Medicine, said in the release. 

“The approval of Onyda XR, the only liquid non-stimulant ADHD medication, with nighttime dosing that shifts the release profile, is a convenient option for patients needing better ADHD control,” she added.

The approval was based on “adequate and well-controlled studies” of the company’s extended-release tablets.

Onyda XR is contraindicated in patients with a history of a hypersensitivity reaction to clonidine. 

The medication can cause dose-related decreases in blood pressure and heart rate. Vital signs should be monitored frequently in at-risk patients. In studies with the extended-release tablets, somnolence and sedation were commonly reported adverse reactions. The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular block, especially in patients taking other sympatholytic drugs, the company noted.

Onyda XR should be available in pharmacies in the second half of 2024.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved Onyda XR (clonidine hydrochloride) for the treatment of attention-deficit/hyperactivity disorder (ADHD), drug manufacturer Tris Pharma announced in a statement.

The drug is the first approved liquid nonstimulant ADHD medication. The once-daily extended-release oral suspension, with nighttime dosing, can be used alone or as an adjunctive therapy to FDA-approved stimulant medications in pediatric patients 6 years of age or older.

“People with ADHD require a range of therapeutic options that are designed for their individual needs, because not every medication or type of therapy works for every patient,” Ann Childress, MD, a psychiatrist and president of the Las Vegas–based Center for Psychiatry and Behavioral Medicine, said in the release. 

“The approval of Onyda XR, the only liquid non-stimulant ADHD medication, with nighttime dosing that shifts the release profile, is a convenient option for patients needing better ADHD control,” she added.

The approval was based on “adequate and well-controlled studies” of the company’s extended-release tablets.

Onyda XR is contraindicated in patients with a history of a hypersensitivity reaction to clonidine. 

The medication can cause dose-related decreases in blood pressure and heart rate. Vital signs should be monitored frequently in at-risk patients. In studies with the extended-release tablets, somnolence and sedation were commonly reported adverse reactions. The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular block, especially in patients taking other sympatholytic drugs, the company noted.

Onyda XR should be available in pharmacies in the second half of 2024.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved Onyda XR (clonidine hydrochloride) for the treatment of attention-deficit/hyperactivity disorder (ADHD), drug manufacturer Tris Pharma announced in a statement.

The drug is the first approved liquid nonstimulant ADHD medication. The once-daily extended-release oral suspension, with nighttime dosing, can be used alone or as an adjunctive therapy to FDA-approved stimulant medications in pediatric patients 6 years of age or older.

“People with ADHD require a range of therapeutic options that are designed for their individual needs, because not every medication or type of therapy works for every patient,” Ann Childress, MD, a psychiatrist and president of the Las Vegas–based Center for Psychiatry and Behavioral Medicine, said in the release. 

“The approval of Onyda XR, the only liquid non-stimulant ADHD medication, with nighttime dosing that shifts the release profile, is a convenient option for patients needing better ADHD control,” she added.

The approval was based on “adequate and well-controlled studies” of the company’s extended-release tablets.

Onyda XR is contraindicated in patients with a history of a hypersensitivity reaction to clonidine. 

The medication can cause dose-related decreases in blood pressure and heart rate. Vital signs should be monitored frequently in at-risk patients. In studies with the extended-release tablets, somnolence and sedation were commonly reported adverse reactions. The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular block, especially in patients taking other sympatholytic drugs, the company noted.

Onyda XR should be available in pharmacies in the second half of 2024.
 

A version of this article appeared on Medscape.com.

Teens with classmates who have a mental illness have a significantly greater risk for a psychiatric diagnosis later in life, even after controlling for parents’ mental health history and other factors, a new study suggested.

The research provides new evidence that adolescents within a specific peer network may possibly “transmit” mental disorders such as depression and anxiety to each other, the investigators noted.

Having a classmate with a mental illness was associated with a 3% higher risk for subsequent psychiatric diagnosis, researchers found. The risk was highest — 13% — in the first year of follow-up and was strongest for mood, anxiety, and eating disorders.

The study is said to the be the largest to date on the topic, including data on more than 700,000 ninth graders in Finland who were followed for up to 18 years.

At least one expert noted that the numbers are higher than he would have expected, but the investigators were quick to caution the study doesn’t prove having a classmate with a mental illness leads to later psychiatric diagnosis among peers.

“The associations observed in the study are not necessarily causal,” lead investigator Jussi Alho, PhD, a postdoctoral researcher at the University of Helsinki, Finland, told this news organization. “The study did not investigate the mechanisms that explain the observed associations.”

The results were published online on May 22 in JAMA Psychiatry.
 

Few Data

Previous studies have reported a clustering of mood symptoms, eating disorders, and other psychiatric illnesses among adolescent and adult social networks. But most involve self-selected peer groups.

“Investigating the transmission of mental disorders is especially important in childhood and adolescence,” the authors noted. “Yet, despite a few survey studies reporting that adolescents may experience increased mental health symptoms when exposed to friends or peers with mental health problems, large-scale studies on the potential peer influences of mental disorders in youth are lacking,” the authors wrote.

Researchers used a database of 713,809 students in the ninth grade, about half boys and half girls. All were born between January 1, 1985, and December 31, 1997. About 47,000 were excluded as they had a mental disorder diagnosis before the study began.

Some 666,000 students in 860 schools were followed from ninth grade until the first diagnosed mental disorder, death, emigration, or the end of the study in 2019. Median follow-up was 11.4 years.

Diagnoses were gathered from Finnish registries for inpatient, outpatient, and primary care and included ICD-9 and ICD-10 diagnoses for substance misuse disorders, schizophrenia spectrum disorders, mood disorders, anxiety disorders, eating disorders, emotional and social-functioning disorders, and hyperkinetic and conduct disorders.

The authors adjusted for sex, birth year, school and ninth-grade class size, area-level urbanicity, area-level morbidity, area-level education, area-level employment rate, parental educational level, and parental mental health, with a random intercept per school.
 

Dose-Response Relationship

Overall, a quarter (167,227) of the students were diagnosed with a mental disorder.

The risk of being diagnosed with any mental disorder was 3% higher during the entire follow-up period (hazard ratio [HR], 1.03; 95% CI, 1.02-1.04). Risk was highest in the first year of follow-up (HR, 1.13; 95% CI, 1.08-1.18) and then rose again in years 4 and 5, when the risk was 5% higher with one diagnosed classmate and 10% higher with more than one diagnosed classmate.

The risk was significantly increased for mood, anxiety, and eating disorders in each follow-up time window. Investigators also noted a dose-response relationship: The more classmates with a psychiatric illness, the greater the risk for later mental illness.

“These findings suggest that mental disorders may be transmitted within adolescent peer networks,” the authors wrote.

The researchers chose to describe the spread of mental disorders among peer classmates as “transmission” in part because it has been previously used in the literature, Dr. Alho said.

Alho said the researchers also believe that transmission is an accurate term to describe the potential mechanisms by which mental disorders may spread.

The authors hypothesized that more students might be diagnosed when disorders are normalized, through increased awareness and receptivity to diagnosis and treatment.

Conversely, the rate of disorders might also have increased — especially in the first year of follow-up — if there were no students in the peer network who had been diagnosed, the authors added. Without an example, it might discourage a student to seek help.

The authors also noted that it’s “conceivable that long-term exposure to a depressive individual could lead to gradual development of depressive symptoms through the well-established neural mechanisms of emotional contagion.”
 

New Direction for Treatment?

Commenting on the findings, Madhukar H. Trivedi, MD, the Betty Jo Hay Distinguished Chair in Mental Health at UT Southwestern Medical School, Dallas, said that the theory that having classmates with psychiatric illness could normalize these conditions has merit.

Once someone is diagnosed or receives treatment, “their peers kind of get implicit permission to be able to then express their own symptoms or express their own problems, which they may have been hiding or not recognized,” he said.

However, Dr. Trivedi disagreed with the authors’ suggestion that the rate of disorders might also have increased if no classmates had received a psychiatric diagnosis, noting that it was unlikely that a student would not have been exposed to depression, anxiety, or another mood disorder — through a peer or family member — given how common those illnesses are.

“The numbers are slightly higher than I would have expected,” Dr. Trivedi said, adding that peer influence having that type of impact “is something that has not been shown before.”

The study is notable for its use of comprehensive registries, which helped solidify the data integrity, Trivedi said, and the results offer some potential new directions for treatment, such as adding peer support. That has been found useful in adult treatment but has been less utilized with adolescents, he said.

The study was funded by the European Union and the Academy of Finland. The authors reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

Teens with classmates who have a mental illness have a significantly greater risk for a psychiatric diagnosis later in life, even after controlling for parents’ mental health history and other factors, a new study suggested.

The research provides new evidence that adolescents within a specific peer network may possibly “transmit” mental disorders such as depression and anxiety to each other, the investigators noted.

Having a classmate with a mental illness was associated with a 3% higher risk for subsequent psychiatric diagnosis, researchers found. The risk was highest — 13% — in the first year of follow-up and was strongest for mood, anxiety, and eating disorders.

The study is said to the be the largest to date on the topic, including data on more than 700,000 ninth graders in Finland who were followed for up to 18 years.

At least one expert noted that the numbers are higher than he would have expected, but the investigators were quick to caution the study doesn’t prove having a classmate with a mental illness leads to later psychiatric diagnosis among peers.

“The associations observed in the study are not necessarily causal,” lead investigator Jussi Alho, PhD, a postdoctoral researcher at the University of Helsinki, Finland, told this news organization. “The study did not investigate the mechanisms that explain the observed associations.”

The results were published online on May 22 in JAMA Psychiatry.
 

Few Data

Previous studies have reported a clustering of mood symptoms, eating disorders, and other psychiatric illnesses among adolescent and adult social networks. But most involve self-selected peer groups.

“Investigating the transmission of mental disorders is especially important in childhood and adolescence,” the authors noted. “Yet, despite a few survey studies reporting that adolescents may experience increased mental health symptoms when exposed to friends or peers with mental health problems, large-scale studies on the potential peer influences of mental disorders in youth are lacking,” the authors wrote.

Researchers used a database of 713,809 students in the ninth grade, about half boys and half girls. All were born between January 1, 1985, and December 31, 1997. About 47,000 were excluded as they had a mental disorder diagnosis before the study began.

Some 666,000 students in 860 schools were followed from ninth grade until the first diagnosed mental disorder, death, emigration, or the end of the study in 2019. Median follow-up was 11.4 years.

Diagnoses were gathered from Finnish registries for inpatient, outpatient, and primary care and included ICD-9 and ICD-10 diagnoses for substance misuse disorders, schizophrenia spectrum disorders, mood disorders, anxiety disorders, eating disorders, emotional and social-functioning disorders, and hyperkinetic and conduct disorders.

The authors adjusted for sex, birth year, school and ninth-grade class size, area-level urbanicity, area-level morbidity, area-level education, area-level employment rate, parental educational level, and parental mental health, with a random intercept per school.
 

Dose-Response Relationship

Overall, a quarter (167,227) of the students were diagnosed with a mental disorder.

The risk of being diagnosed with any mental disorder was 3% higher during the entire follow-up period (hazard ratio [HR], 1.03; 95% CI, 1.02-1.04). Risk was highest in the first year of follow-up (HR, 1.13; 95% CI, 1.08-1.18) and then rose again in years 4 and 5, when the risk was 5% higher with one diagnosed classmate and 10% higher with more than one diagnosed classmate.

The risk was significantly increased for mood, anxiety, and eating disorders in each follow-up time window. Investigators also noted a dose-response relationship: The more classmates with a psychiatric illness, the greater the risk for later mental illness.

“These findings suggest that mental disorders may be transmitted within adolescent peer networks,” the authors wrote.

The researchers chose to describe the spread of mental disorders among peer classmates as “transmission” in part because it has been previously used in the literature, Dr. Alho said.

Alho said the researchers also believe that transmission is an accurate term to describe the potential mechanisms by which mental disorders may spread.

The authors hypothesized that more students might be diagnosed when disorders are normalized, through increased awareness and receptivity to diagnosis and treatment.

Conversely, the rate of disorders might also have increased — especially in the first year of follow-up — if there were no students in the peer network who had been diagnosed, the authors added. Without an example, it might discourage a student to seek help.

The authors also noted that it’s “conceivable that long-term exposure to a depressive individual could lead to gradual development of depressive symptoms through the well-established neural mechanisms of emotional contagion.”
 

New Direction for Treatment?

Commenting on the findings, Madhukar H. Trivedi, MD, the Betty Jo Hay Distinguished Chair in Mental Health at UT Southwestern Medical School, Dallas, said that the theory that having classmates with psychiatric illness could normalize these conditions has merit.

Once someone is diagnosed or receives treatment, “their peers kind of get implicit permission to be able to then express their own symptoms or express their own problems, which they may have been hiding or not recognized,” he said.

However, Dr. Trivedi disagreed with the authors’ suggestion that the rate of disorders might also have increased if no classmates had received a psychiatric diagnosis, noting that it was unlikely that a student would not have been exposed to depression, anxiety, or another mood disorder — through a peer or family member — given how common those illnesses are.

“The numbers are slightly higher than I would have expected,” Dr. Trivedi said, adding that peer influence having that type of impact “is something that has not been shown before.”

The study is notable for its use of comprehensive registries, which helped solidify the data integrity, Trivedi said, and the results offer some potential new directions for treatment, such as adding peer support. That has been found useful in adult treatment but has been less utilized with adolescents, he said.

The study was funded by the European Union and the Academy of Finland. The authors reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

Teens with classmates who have a mental illness have a significantly greater risk for a psychiatric diagnosis later in life, even after controlling for parents’ mental health history and other factors, a new study suggested.

The research provides new evidence that adolescents within a specific peer network may possibly “transmit” mental disorders such as depression and anxiety to each other, the investigators noted.

Having a classmate with a mental illness was associated with a 3% higher risk for subsequent psychiatric diagnosis, researchers found. The risk was highest — 13% — in the first year of follow-up and was strongest for mood, anxiety, and eating disorders.

The study is said to the be the largest to date on the topic, including data on more than 700,000 ninth graders in Finland who were followed for up to 18 years.

At least one expert noted that the numbers are higher than he would have expected, but the investigators were quick to caution the study doesn’t prove having a classmate with a mental illness leads to later psychiatric diagnosis among peers.

“The associations observed in the study are not necessarily causal,” lead investigator Jussi Alho, PhD, a postdoctoral researcher at the University of Helsinki, Finland, told this news organization. “The study did not investigate the mechanisms that explain the observed associations.”

The results were published online on May 22 in JAMA Psychiatry.
 

Few Data

Previous studies have reported a clustering of mood symptoms, eating disorders, and other psychiatric illnesses among adolescent and adult social networks. But most involve self-selected peer groups.

“Investigating the transmission of mental disorders is especially important in childhood and adolescence,” the authors noted. “Yet, despite a few survey studies reporting that adolescents may experience increased mental health symptoms when exposed to friends or peers with mental health problems, large-scale studies on the potential peer influences of mental disorders in youth are lacking,” the authors wrote.

Researchers used a database of 713,809 students in the ninth grade, about half boys and half girls. All were born between January 1, 1985, and December 31, 1997. About 47,000 were excluded as they had a mental disorder diagnosis before the study began.

Some 666,000 students in 860 schools were followed from ninth grade until the first diagnosed mental disorder, death, emigration, or the end of the study in 2019. Median follow-up was 11.4 years.

Diagnoses were gathered from Finnish registries for inpatient, outpatient, and primary care and included ICD-9 and ICD-10 diagnoses for substance misuse disorders, schizophrenia spectrum disorders, mood disorders, anxiety disorders, eating disorders, emotional and social-functioning disorders, and hyperkinetic and conduct disorders.

The authors adjusted for sex, birth year, school and ninth-grade class size, area-level urbanicity, area-level morbidity, area-level education, area-level employment rate, parental educational level, and parental mental health, with a random intercept per school.
 

Dose-Response Relationship

Overall, a quarter (167,227) of the students were diagnosed with a mental disorder.

The risk of being diagnosed with any mental disorder was 3% higher during the entire follow-up period (hazard ratio [HR], 1.03; 95% CI, 1.02-1.04). Risk was highest in the first year of follow-up (HR, 1.13; 95% CI, 1.08-1.18) and then rose again in years 4 and 5, when the risk was 5% higher with one diagnosed classmate and 10% higher with more than one diagnosed classmate.

The risk was significantly increased for mood, anxiety, and eating disorders in each follow-up time window. Investigators also noted a dose-response relationship: The more classmates with a psychiatric illness, the greater the risk for later mental illness.

“These findings suggest that mental disorders may be transmitted within adolescent peer networks,” the authors wrote.

The researchers chose to describe the spread of mental disorders among peer classmates as “transmission” in part because it has been previously used in the literature, Dr. Alho said.

Alho said the researchers also believe that transmission is an accurate term to describe the potential mechanisms by which mental disorders may spread.

The authors hypothesized that more students might be diagnosed when disorders are normalized, through increased awareness and receptivity to diagnosis and treatment.

Conversely, the rate of disorders might also have increased — especially in the first year of follow-up — if there were no students in the peer network who had been diagnosed, the authors added. Without an example, it might discourage a student to seek help.

The authors also noted that it’s “conceivable that long-term exposure to a depressive individual could lead to gradual development of depressive symptoms through the well-established neural mechanisms of emotional contagion.”
 

New Direction for Treatment?

Commenting on the findings, Madhukar H. Trivedi, MD, the Betty Jo Hay Distinguished Chair in Mental Health at UT Southwestern Medical School, Dallas, said that the theory that having classmates with psychiatric illness could normalize these conditions has merit.

Once someone is diagnosed or receives treatment, “their peers kind of get implicit permission to be able to then express their own symptoms or express their own problems, which they may have been hiding or not recognized,” he said.

However, Dr. Trivedi disagreed with the authors’ suggestion that the rate of disorders might also have increased if no classmates had received a psychiatric diagnosis, noting that it was unlikely that a student would not have been exposed to depression, anxiety, or another mood disorder — through a peer or family member — given how common those illnesses are.

“The numbers are slightly higher than I would have expected,” Dr. Trivedi said, adding that peer influence having that type of impact “is something that has not been shown before.”

The study is notable for its use of comprehensive registries, which helped solidify the data integrity, Trivedi said, and the results offer some potential new directions for treatment, such as adding peer support. That has been found useful in adult treatment but has been less utilized with adolescents, he said.

The study was funded by the European Union and the Academy of Finland. The authors reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.