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Does racial bias taint the Apgar score?
Experts say overhaul needed
In 1952, when Dr. Virginia Apgar developed her 10-point scale for assessing neonates’ health, the U.S. obstetrical anesthesiologst may not have foreseen it would one day become one of the commonest medical tests in the world.
Assigned even before the mother first holds her newborn, the score rapidly evaluates neonates with a score of 0-10, which leads to an algorithm of potential medical interventions. The scale evaluates heart rate, respiratory effort, muscle tone, reflex response, and skin coloring (typically described as blue body, pink body/blue limbs, or pink body).
“The Apgar is a very important tool used in millions of babies around the world in the very first minute after birth,” said Amos Grunebaum, MD, a professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y., and director of perinatal research at Northwell Lenox Hill Hospital in Manhattan.
But recently the venerable system has increasingly come under fire for colorism and racial bias, with some calling for an overhaul. That pressure is due to the 2 out of 10 points allotted to an overall “pink” skin tone, a measure that lowers the scores of non-White newborns and may expose them to unnecessary measures such as resuscitation, neonatal intensive care, and intubation.
“This is their first encounter with systemic racism,” said Dr. Grunebaum in an interview. “The score is prejudiced against Black babies because they can’t get perfect scores.”
Propagating ‘race-based medicine’
Concern about racial bias embedded in the Apgar score is not new, Dr. Grunebaum noted.
“Decades ago, when I was doing my training in Brooklyn, the nurses said that using skin color was ridiculous since Black and brown babies couldn’t be pink. And skin color looks different in different lighting. Dr. Apgar herself recognized the problem.”
Furthermore, men see color differently than women do, and some people are actually color-blind.“But nobody wanted to speak out,” Dr. Grunebaum said. “It was like the emperor’s new clothes scenario.”
In his view, embedding skin color scoring into basic data and health care decisions propagates race-based medicine. “It should not be used for White, Black, or brown babies,” he said.
Removing the skin color portion of the Apgar score – and its racial, colorist, and ethnic bias – will provide more accurate and equitable evaluation of newborn babies worldwide, Dr. Grunebaum said.
“I think there’s a pretty good argument to be made that the skin color measure should be eliminated,” agreed Sara E. Edwards, MD, an obstetrician-gynecologist at the University of Illinois Hospital in Chicago, who has also studied Apgar and racial bias in the clinical care of Black babies.
And such clinical bias may soon be illegal in the United States thanks to a proposed new antidiscrimination provision to the Affordable Care Act regarding the use of clinical algorithms in decision-making. The proposed section, § 92.210, states that a covered entity must not discriminate against any individual on the basis of race, color, national origin, sex, age, or disability through clinical algorithms used in decision-making. Hospitals may soon have to alter clinical algorithms in response.
Dr. Grunebaum’s research in the area of clinical racism includes a large 2022 cohort study of almost 10 million mothers and more than 8 million fathers using 2016-2019 natality data from the National Center for Health Statistics, and Division of Vital Statistics. This study found that Black newborns had a less than 50% chance of having a 5-minute Apgar score of 10, compared with White newborns. White babies, both non-Hispanic and Hispanic, had the highest proportion of perfect 10s.
But can the 2-point skin tone indicator be easily replaced? According to Dr. Grunebaum, substituting indicators such as oral mucosa color or oximetry readings are not satisfactory either. “For one thing, oximetry gives different readings in Black [people],” he said.
In her group’s Apgar research, Dr. Edwards found that care providers applied variable and inaccurate scores based on neonatal race – independently of clinical factors and umbilical-cord gas values.
“In Black neonates umbilical cord gases were not in agreement with lower Apgar scores,” she said. In her view, these inaccuracies point to the existence of colorism and racial bias among health care providers.
Bias ‘creeping in’ to neonatal care
Dr. Edwards’s research was prompted by anecdotal observations that Black babies generally had lower Apgar scores and were more frequently sent to the NICU. “Admission to the NICU can have a negative effect on maternal-child bonding and contribute to PTSD in mothers,” she said.
Her group looked at Apgar scores by race for the year 2019 in an academic hospital cohort of 977 neonates, of whom 56.5% were Black, while controlling for confounding clinical factors.
“Our anecdotal observations of how we score Black neonates were confirmed,” she said. Providers assigned Black babies significantly lower Apgar scores at 1 minute and 5 minutes (odds ratios, .63 and .64) when controlling for umbilical artery gases, gestational age, and maternal-fetal complications.
This difference was specifically associated with lower assigned color Apgar scores at 1 minute (odds ratio, .52). Moreover, full-term Black neonates were sent to neonatal intensive care at higher rates (odds ratio, 1.29) than non-Black neonates when controlling for all the above factors.
Providers applied inaccurate Apgar scores to Black neonates given that the umbilical cord gases were not in agreement with lower Apgar scores, suggesting that colorism and racial biases do exist among health care providers. “We saw bias creeping in because of subjective decisions about color,” Dr. Edwards said. But by the more objective measure of umbilical-cord gas, Black neonates did not have the abnormal values to support NICU admission. The mean umbilical artery pH was 7.259 for Black vs. 7.256 for non-Black neonates.
The solution may lie in switching to an 8 out of 8 score or looking at other indicators such as the eyes and the nail beds, she said. “Or there may be a way to score skin tone accurately when providers are appropriately trained to do so on neonates of all races, to recognize what a well-perfused skin color looks like in all babies.”
New scoring system needed
Interest in this issue continues. In 2022, a population study was conducted by Emma Gillette, MPH, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues in a cohort of almost 7 million singletons born in 2016-2017.
“We found that overall, Apgar scores were highly associated with mortality across the first year of life,” Ms. Gillette said in an interview. “But non-Hispanic Black infants were more likely to be assigned low Apgar scores compared to White infants, and the odds of death in the first year of life are not as strongly correlated with Apgar scores as in White infants.”
That finding was surprising. “Apgar scores are meant to be an indicator of newborn health and well-being and predictors of infant mortality, and therefore should not vary significantly by race or skin color,” she said. “So I think further study into the component scores of the Apgar score is warranted to try to tease out the reasons behind the differences we’re seeing.”
Ms. Gillette agreed that the skin coloring component of the variable could be inaccurate since variables related to skin color more generally are subjective and difficult to measure. What’s needed is a scoring system that performs equally well across racial groups.
In the meantime, some clinicians may be making practical accommodations. “I hate to tell you, but some people fake the skin score,” said Dr. Grunebaum. “I recently asked a doctor from Ethiopia how they handled it there, and he laughed and said they just automatically give skin color a 2. But faking it is not what you should have to do in medicine.”
Dr. Grunebaum, Dr. Edwards, and Ms. Gillette disclosed no relevant competing interests with respect to their comments.
Experts say overhaul needed
Experts say overhaul needed
In 1952, when Dr. Virginia Apgar developed her 10-point scale for assessing neonates’ health, the U.S. obstetrical anesthesiologst may not have foreseen it would one day become one of the commonest medical tests in the world.
Assigned even before the mother first holds her newborn, the score rapidly evaluates neonates with a score of 0-10, which leads to an algorithm of potential medical interventions. The scale evaluates heart rate, respiratory effort, muscle tone, reflex response, and skin coloring (typically described as blue body, pink body/blue limbs, or pink body).
“The Apgar is a very important tool used in millions of babies around the world in the very first minute after birth,” said Amos Grunebaum, MD, a professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y., and director of perinatal research at Northwell Lenox Hill Hospital in Manhattan.
But recently the venerable system has increasingly come under fire for colorism and racial bias, with some calling for an overhaul. That pressure is due to the 2 out of 10 points allotted to an overall “pink” skin tone, a measure that lowers the scores of non-White newborns and may expose them to unnecessary measures such as resuscitation, neonatal intensive care, and intubation.
“This is their first encounter with systemic racism,” said Dr. Grunebaum in an interview. “The score is prejudiced against Black babies because they can’t get perfect scores.”
Propagating ‘race-based medicine’
Concern about racial bias embedded in the Apgar score is not new, Dr. Grunebaum noted.
“Decades ago, when I was doing my training in Brooklyn, the nurses said that using skin color was ridiculous since Black and brown babies couldn’t be pink. And skin color looks different in different lighting. Dr. Apgar herself recognized the problem.”
Furthermore, men see color differently than women do, and some people are actually color-blind.“But nobody wanted to speak out,” Dr. Grunebaum said. “It was like the emperor’s new clothes scenario.”
In his view, embedding skin color scoring into basic data and health care decisions propagates race-based medicine. “It should not be used for White, Black, or brown babies,” he said.
Removing the skin color portion of the Apgar score – and its racial, colorist, and ethnic bias – will provide more accurate and equitable evaluation of newborn babies worldwide, Dr. Grunebaum said.
“I think there’s a pretty good argument to be made that the skin color measure should be eliminated,” agreed Sara E. Edwards, MD, an obstetrician-gynecologist at the University of Illinois Hospital in Chicago, who has also studied Apgar and racial bias in the clinical care of Black babies.
And such clinical bias may soon be illegal in the United States thanks to a proposed new antidiscrimination provision to the Affordable Care Act regarding the use of clinical algorithms in decision-making. The proposed section, § 92.210, states that a covered entity must not discriminate against any individual on the basis of race, color, national origin, sex, age, or disability through clinical algorithms used in decision-making. Hospitals may soon have to alter clinical algorithms in response.
Dr. Grunebaum’s research in the area of clinical racism includes a large 2022 cohort study of almost 10 million mothers and more than 8 million fathers using 2016-2019 natality data from the National Center for Health Statistics, and Division of Vital Statistics. This study found that Black newborns had a less than 50% chance of having a 5-minute Apgar score of 10, compared with White newborns. White babies, both non-Hispanic and Hispanic, had the highest proportion of perfect 10s.
But can the 2-point skin tone indicator be easily replaced? According to Dr. Grunebaum, substituting indicators such as oral mucosa color or oximetry readings are not satisfactory either. “For one thing, oximetry gives different readings in Black [people],” he said.
In her group’s Apgar research, Dr. Edwards found that care providers applied variable and inaccurate scores based on neonatal race – independently of clinical factors and umbilical-cord gas values.
“In Black neonates umbilical cord gases were not in agreement with lower Apgar scores,” she said. In her view, these inaccuracies point to the existence of colorism and racial bias among health care providers.
Bias ‘creeping in’ to neonatal care
Dr. Edwards’s research was prompted by anecdotal observations that Black babies generally had lower Apgar scores and were more frequently sent to the NICU. “Admission to the NICU can have a negative effect on maternal-child bonding and contribute to PTSD in mothers,” she said.
Her group looked at Apgar scores by race for the year 2019 in an academic hospital cohort of 977 neonates, of whom 56.5% were Black, while controlling for confounding clinical factors.
“Our anecdotal observations of how we score Black neonates were confirmed,” she said. Providers assigned Black babies significantly lower Apgar scores at 1 minute and 5 minutes (odds ratios, .63 and .64) when controlling for umbilical artery gases, gestational age, and maternal-fetal complications.
This difference was specifically associated with lower assigned color Apgar scores at 1 minute (odds ratio, .52). Moreover, full-term Black neonates were sent to neonatal intensive care at higher rates (odds ratio, 1.29) than non-Black neonates when controlling for all the above factors.
Providers applied inaccurate Apgar scores to Black neonates given that the umbilical cord gases were not in agreement with lower Apgar scores, suggesting that colorism and racial biases do exist among health care providers. “We saw bias creeping in because of subjective decisions about color,” Dr. Edwards said. But by the more objective measure of umbilical-cord gas, Black neonates did not have the abnormal values to support NICU admission. The mean umbilical artery pH was 7.259 for Black vs. 7.256 for non-Black neonates.
The solution may lie in switching to an 8 out of 8 score or looking at other indicators such as the eyes and the nail beds, she said. “Or there may be a way to score skin tone accurately when providers are appropriately trained to do so on neonates of all races, to recognize what a well-perfused skin color looks like in all babies.”
New scoring system needed
Interest in this issue continues. In 2022, a population study was conducted by Emma Gillette, MPH, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues in a cohort of almost 7 million singletons born in 2016-2017.
“We found that overall, Apgar scores were highly associated with mortality across the first year of life,” Ms. Gillette said in an interview. “But non-Hispanic Black infants were more likely to be assigned low Apgar scores compared to White infants, and the odds of death in the first year of life are not as strongly correlated with Apgar scores as in White infants.”
That finding was surprising. “Apgar scores are meant to be an indicator of newborn health and well-being and predictors of infant mortality, and therefore should not vary significantly by race or skin color,” she said. “So I think further study into the component scores of the Apgar score is warranted to try to tease out the reasons behind the differences we’re seeing.”
Ms. Gillette agreed that the skin coloring component of the variable could be inaccurate since variables related to skin color more generally are subjective and difficult to measure. What’s needed is a scoring system that performs equally well across racial groups.
In the meantime, some clinicians may be making practical accommodations. “I hate to tell you, but some people fake the skin score,” said Dr. Grunebaum. “I recently asked a doctor from Ethiopia how they handled it there, and he laughed and said they just automatically give skin color a 2. But faking it is not what you should have to do in medicine.”
Dr. Grunebaum, Dr. Edwards, and Ms. Gillette disclosed no relevant competing interests with respect to their comments.
In 1952, when Dr. Virginia Apgar developed her 10-point scale for assessing neonates’ health, the U.S. obstetrical anesthesiologst may not have foreseen it would one day become one of the commonest medical tests in the world.
Assigned even before the mother first holds her newborn, the score rapidly evaluates neonates with a score of 0-10, which leads to an algorithm of potential medical interventions. The scale evaluates heart rate, respiratory effort, muscle tone, reflex response, and skin coloring (typically described as blue body, pink body/blue limbs, or pink body).
“The Apgar is a very important tool used in millions of babies around the world in the very first minute after birth,” said Amos Grunebaum, MD, a professor of obstetrics and gynecology at Hofstra University, Hempstead, N.Y., and director of perinatal research at Northwell Lenox Hill Hospital in Manhattan.
But recently the venerable system has increasingly come under fire for colorism and racial bias, with some calling for an overhaul. That pressure is due to the 2 out of 10 points allotted to an overall “pink” skin tone, a measure that lowers the scores of non-White newborns and may expose them to unnecessary measures such as resuscitation, neonatal intensive care, and intubation.
“This is their first encounter with systemic racism,” said Dr. Grunebaum in an interview. “The score is prejudiced against Black babies because they can’t get perfect scores.”
Propagating ‘race-based medicine’
Concern about racial bias embedded in the Apgar score is not new, Dr. Grunebaum noted.
“Decades ago, when I was doing my training in Brooklyn, the nurses said that using skin color was ridiculous since Black and brown babies couldn’t be pink. And skin color looks different in different lighting. Dr. Apgar herself recognized the problem.”
Furthermore, men see color differently than women do, and some people are actually color-blind.“But nobody wanted to speak out,” Dr. Grunebaum said. “It was like the emperor’s new clothes scenario.”
In his view, embedding skin color scoring into basic data and health care decisions propagates race-based medicine. “It should not be used for White, Black, or brown babies,” he said.
Removing the skin color portion of the Apgar score – and its racial, colorist, and ethnic bias – will provide more accurate and equitable evaluation of newborn babies worldwide, Dr. Grunebaum said.
“I think there’s a pretty good argument to be made that the skin color measure should be eliminated,” agreed Sara E. Edwards, MD, an obstetrician-gynecologist at the University of Illinois Hospital in Chicago, who has also studied Apgar and racial bias in the clinical care of Black babies.
And such clinical bias may soon be illegal in the United States thanks to a proposed new antidiscrimination provision to the Affordable Care Act regarding the use of clinical algorithms in decision-making. The proposed section, § 92.210, states that a covered entity must not discriminate against any individual on the basis of race, color, national origin, sex, age, or disability through clinical algorithms used in decision-making. Hospitals may soon have to alter clinical algorithms in response.
Dr. Grunebaum’s research in the area of clinical racism includes a large 2022 cohort study of almost 10 million mothers and more than 8 million fathers using 2016-2019 natality data from the National Center for Health Statistics, and Division of Vital Statistics. This study found that Black newborns had a less than 50% chance of having a 5-minute Apgar score of 10, compared with White newborns. White babies, both non-Hispanic and Hispanic, had the highest proportion of perfect 10s.
But can the 2-point skin tone indicator be easily replaced? According to Dr. Grunebaum, substituting indicators such as oral mucosa color or oximetry readings are not satisfactory either. “For one thing, oximetry gives different readings in Black [people],” he said.
In her group’s Apgar research, Dr. Edwards found that care providers applied variable and inaccurate scores based on neonatal race – independently of clinical factors and umbilical-cord gas values.
“In Black neonates umbilical cord gases were not in agreement with lower Apgar scores,” she said. In her view, these inaccuracies point to the existence of colorism and racial bias among health care providers.
Bias ‘creeping in’ to neonatal care
Dr. Edwards’s research was prompted by anecdotal observations that Black babies generally had lower Apgar scores and were more frequently sent to the NICU. “Admission to the NICU can have a negative effect on maternal-child bonding and contribute to PTSD in mothers,” she said.
Her group looked at Apgar scores by race for the year 2019 in an academic hospital cohort of 977 neonates, of whom 56.5% were Black, while controlling for confounding clinical factors.
“Our anecdotal observations of how we score Black neonates were confirmed,” she said. Providers assigned Black babies significantly lower Apgar scores at 1 minute and 5 minutes (odds ratios, .63 and .64) when controlling for umbilical artery gases, gestational age, and maternal-fetal complications.
This difference was specifically associated with lower assigned color Apgar scores at 1 minute (odds ratio, .52). Moreover, full-term Black neonates were sent to neonatal intensive care at higher rates (odds ratio, 1.29) than non-Black neonates when controlling for all the above factors.
Providers applied inaccurate Apgar scores to Black neonates given that the umbilical cord gases were not in agreement with lower Apgar scores, suggesting that colorism and racial biases do exist among health care providers. “We saw bias creeping in because of subjective decisions about color,” Dr. Edwards said. But by the more objective measure of umbilical-cord gas, Black neonates did not have the abnormal values to support NICU admission. The mean umbilical artery pH was 7.259 for Black vs. 7.256 for non-Black neonates.
The solution may lie in switching to an 8 out of 8 score or looking at other indicators such as the eyes and the nail beds, she said. “Or there may be a way to score skin tone accurately when providers are appropriately trained to do so on neonates of all races, to recognize what a well-perfused skin color looks like in all babies.”
New scoring system needed
Interest in this issue continues. In 2022, a population study was conducted by Emma Gillette, MPH, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues in a cohort of almost 7 million singletons born in 2016-2017.
“We found that overall, Apgar scores were highly associated with mortality across the first year of life,” Ms. Gillette said in an interview. “But non-Hispanic Black infants were more likely to be assigned low Apgar scores compared to White infants, and the odds of death in the first year of life are not as strongly correlated with Apgar scores as in White infants.”
That finding was surprising. “Apgar scores are meant to be an indicator of newborn health and well-being and predictors of infant mortality, and therefore should not vary significantly by race or skin color,” she said. “So I think further study into the component scores of the Apgar score is warranted to try to tease out the reasons behind the differences we’re seeing.”
Ms. Gillette agreed that the skin coloring component of the variable could be inaccurate since variables related to skin color more generally are subjective and difficult to measure. What’s needed is a scoring system that performs equally well across racial groups.
In the meantime, some clinicians may be making practical accommodations. “I hate to tell you, but some people fake the skin score,” said Dr. Grunebaum. “I recently asked a doctor from Ethiopia how they handled it there, and he laughed and said they just automatically give skin color a 2. But faking it is not what you should have to do in medicine.”
Dr. Grunebaum, Dr. Edwards, and Ms. Gillette disclosed no relevant competing interests with respect to their comments.
AMA supports APRN oversight by both medical and nursing boards
In a move that raises the stakes in doctors’ ongoing scope-creep battle against nonphysician providers, the American Medical Association’s legislative body voted recently to change its policy on the supervision of advanced practice registered nurses (APRNs). AMA’s House of Delegates called for state medical boards to regulate APRNs in addition to nursing boards.
The AMA has long claimed that nonphysician providers, such as nurse practitioners (NPs) and physician assistants (PAs), need greater oversight because expanded scope of practice for advanced practice practitioners threatens patient safety and undermines the physician-led team model.
APRNs have been touted as a solution to expand access to care and reduce disparities, especially in rural and underserved communities, and they have been promoted by organizations such as the National Academy of Medicine. But the AMA disputes that scope expansions are necessary to increase access to care.
The organization that represents the nation’s physicians said in a prepared statement that it opposes scope expansions because removing doctors from the care team results in higher costs to the patient and lower quality care.
Several nursing organizations swiftly criticized the policy recommendation, including the American Nurses Association, the American Association of Nurse Practitioners, and the National Council of State Boards of Nursing.
The policy shift would create more administrative burdens for APRNs and generate “a downstream effect that only hurts patients,” particularly those in underserved communities without timely access to care, ANA president Jennifer Mensik Kennedy, PhD, MBA, RN, NEA-BC, told this news organization.
“The licensing and regulation of APRNs have never required the oversight of state medical boards,” she said, adding that it should remain the obligation of nursing regulatory bodies.
Jon Fanning, MS, CAE, CNED, chief executive officer of the AANP, called the AMA proposal “flawed.”
“The restrictive involvement of the board of medicine directly contributes to health care access challenges, resulting in continued low health care rankings, geographic disparities in care, and unnecessary regulatory cost in these states,” he said in a press release.
Still, the AMA has vowed to #StopScopeCreep. Securing stricter practice guidelines was a central theme of the association’s recent annual meeting and a goal of its plan to strengthen the physician workforce. The organization invests heavily in advocacy and education efforts to defeat state bills seeking to extend APRN authority. To that end, the AMA Scope of Practice Partnership, a coalition of over 100 medical associations, has awarded members $3.5 million in grants to combat scope-expansion legislation.
The AMA and the American College of Radiology recently partnered to create advocacy materials, including handouts encouraging patients to ask questions such as: “Will a physician be reviewing my chart, lab results, x-rays, and other tests?”
The policy recommendation comes as concerns mount over the potential for significant physician shortages, fueled partly by older physicians’ retirements and doctors reducing hours or exiting the workforce due to pandemic fatigue and burnout.
While practice regulations vary by state, a new federal bill could change that by broadening the authority of APRNs under Medicare and Medicaid guidelines. Introduced in the U.S. House of Representatives in April and supported by the ANA, the Improving Care and Access to Nurses Act would allow APRNs to perform more procedures, including cardiac and pulmonary rehabilitation and certification of terminal illness for hospice, according to an ANA press release.
In the meantime, several state legislatures are considering bills that would expand APRN scope of practice. Utah is the latest to join a growing list of states – about half now – offering full practice authority to NPs.
Other states offer a reduced scope of practice for APRNs, typically requiring a collaborative agreement with a supervising physician. The remaining states enforce tighter regulations and physician oversight.
A recent Medscape survey found that most physicians report having a good rapport with NPs but many have mixed feelings about giving them expanded practice roles, with one-third saying it would harm patient care. Feelings were only slightly more favorable toward PAs. However, about 75% of patients were either neutral or supportive of independent practice for NPs and PAs.
A version of this article first appeared on Medscape.com.
In a move that raises the stakes in doctors’ ongoing scope-creep battle against nonphysician providers, the American Medical Association’s legislative body voted recently to change its policy on the supervision of advanced practice registered nurses (APRNs). AMA’s House of Delegates called for state medical boards to regulate APRNs in addition to nursing boards.
The AMA has long claimed that nonphysician providers, such as nurse practitioners (NPs) and physician assistants (PAs), need greater oversight because expanded scope of practice for advanced practice practitioners threatens patient safety and undermines the physician-led team model.
APRNs have been touted as a solution to expand access to care and reduce disparities, especially in rural and underserved communities, and they have been promoted by organizations such as the National Academy of Medicine. But the AMA disputes that scope expansions are necessary to increase access to care.
The organization that represents the nation’s physicians said in a prepared statement that it opposes scope expansions because removing doctors from the care team results in higher costs to the patient and lower quality care.
Several nursing organizations swiftly criticized the policy recommendation, including the American Nurses Association, the American Association of Nurse Practitioners, and the National Council of State Boards of Nursing.
The policy shift would create more administrative burdens for APRNs and generate “a downstream effect that only hurts patients,” particularly those in underserved communities without timely access to care, ANA president Jennifer Mensik Kennedy, PhD, MBA, RN, NEA-BC, told this news organization.
“The licensing and regulation of APRNs have never required the oversight of state medical boards,” she said, adding that it should remain the obligation of nursing regulatory bodies.
Jon Fanning, MS, CAE, CNED, chief executive officer of the AANP, called the AMA proposal “flawed.”
“The restrictive involvement of the board of medicine directly contributes to health care access challenges, resulting in continued low health care rankings, geographic disparities in care, and unnecessary regulatory cost in these states,” he said in a press release.
Still, the AMA has vowed to #StopScopeCreep. Securing stricter practice guidelines was a central theme of the association’s recent annual meeting and a goal of its plan to strengthen the physician workforce. The organization invests heavily in advocacy and education efforts to defeat state bills seeking to extend APRN authority. To that end, the AMA Scope of Practice Partnership, a coalition of over 100 medical associations, has awarded members $3.5 million in grants to combat scope-expansion legislation.
The AMA and the American College of Radiology recently partnered to create advocacy materials, including handouts encouraging patients to ask questions such as: “Will a physician be reviewing my chart, lab results, x-rays, and other tests?”
The policy recommendation comes as concerns mount over the potential for significant physician shortages, fueled partly by older physicians’ retirements and doctors reducing hours or exiting the workforce due to pandemic fatigue and burnout.
While practice regulations vary by state, a new federal bill could change that by broadening the authority of APRNs under Medicare and Medicaid guidelines. Introduced in the U.S. House of Representatives in April and supported by the ANA, the Improving Care and Access to Nurses Act would allow APRNs to perform more procedures, including cardiac and pulmonary rehabilitation and certification of terminal illness for hospice, according to an ANA press release.
In the meantime, several state legislatures are considering bills that would expand APRN scope of practice. Utah is the latest to join a growing list of states – about half now – offering full practice authority to NPs.
Other states offer a reduced scope of practice for APRNs, typically requiring a collaborative agreement with a supervising physician. The remaining states enforce tighter regulations and physician oversight.
A recent Medscape survey found that most physicians report having a good rapport with NPs but many have mixed feelings about giving them expanded practice roles, with one-third saying it would harm patient care. Feelings were only slightly more favorable toward PAs. However, about 75% of patients were either neutral or supportive of independent practice for NPs and PAs.
A version of this article first appeared on Medscape.com.
In a move that raises the stakes in doctors’ ongoing scope-creep battle against nonphysician providers, the American Medical Association’s legislative body voted recently to change its policy on the supervision of advanced practice registered nurses (APRNs). AMA’s House of Delegates called for state medical boards to regulate APRNs in addition to nursing boards.
The AMA has long claimed that nonphysician providers, such as nurse practitioners (NPs) and physician assistants (PAs), need greater oversight because expanded scope of practice for advanced practice practitioners threatens patient safety and undermines the physician-led team model.
APRNs have been touted as a solution to expand access to care and reduce disparities, especially in rural and underserved communities, and they have been promoted by organizations such as the National Academy of Medicine. But the AMA disputes that scope expansions are necessary to increase access to care.
The organization that represents the nation’s physicians said in a prepared statement that it opposes scope expansions because removing doctors from the care team results in higher costs to the patient and lower quality care.
Several nursing organizations swiftly criticized the policy recommendation, including the American Nurses Association, the American Association of Nurse Practitioners, and the National Council of State Boards of Nursing.
The policy shift would create more administrative burdens for APRNs and generate “a downstream effect that only hurts patients,” particularly those in underserved communities without timely access to care, ANA president Jennifer Mensik Kennedy, PhD, MBA, RN, NEA-BC, told this news organization.
“The licensing and regulation of APRNs have never required the oversight of state medical boards,” she said, adding that it should remain the obligation of nursing regulatory bodies.
Jon Fanning, MS, CAE, CNED, chief executive officer of the AANP, called the AMA proposal “flawed.”
“The restrictive involvement of the board of medicine directly contributes to health care access challenges, resulting in continued low health care rankings, geographic disparities in care, and unnecessary regulatory cost in these states,” he said in a press release.
Still, the AMA has vowed to #StopScopeCreep. Securing stricter practice guidelines was a central theme of the association’s recent annual meeting and a goal of its plan to strengthen the physician workforce. The organization invests heavily in advocacy and education efforts to defeat state bills seeking to extend APRN authority. To that end, the AMA Scope of Practice Partnership, a coalition of over 100 medical associations, has awarded members $3.5 million in grants to combat scope-expansion legislation.
The AMA and the American College of Radiology recently partnered to create advocacy materials, including handouts encouraging patients to ask questions such as: “Will a physician be reviewing my chart, lab results, x-rays, and other tests?”
The policy recommendation comes as concerns mount over the potential for significant physician shortages, fueled partly by older physicians’ retirements and doctors reducing hours or exiting the workforce due to pandemic fatigue and burnout.
While practice regulations vary by state, a new federal bill could change that by broadening the authority of APRNs under Medicare and Medicaid guidelines. Introduced in the U.S. House of Representatives in April and supported by the ANA, the Improving Care and Access to Nurses Act would allow APRNs to perform more procedures, including cardiac and pulmonary rehabilitation and certification of terminal illness for hospice, according to an ANA press release.
In the meantime, several state legislatures are considering bills that would expand APRN scope of practice. Utah is the latest to join a growing list of states – about half now – offering full practice authority to NPs.
Other states offer a reduced scope of practice for APRNs, typically requiring a collaborative agreement with a supervising physician. The remaining states enforce tighter regulations and physician oversight.
A recent Medscape survey found that most physicians report having a good rapport with NPs but many have mixed feelings about giving them expanded practice roles, with one-third saying it would harm patient care. Feelings were only slightly more favorable toward PAs. However, about 75% of patients were either neutral or supportive of independent practice for NPs and PAs.
A version of this article first appeared on Medscape.com.
Nearly one in five in U.S. still hadn’t gotten COVID by end of 2022
, according to a new estimate.
The findings came from an analysis of blood donations. The Centers for Disease Control and Prevention analyzed donor blood from 143,000 people every 3 months during 2022, looking for the presence of COVID antibodies that meant a person had previously been infected with the virus. The prevalence of antibodies from previous infections steadily rose throughout the year. Antibodies from prior infection were found in 49% of donors as of Feb. 15, 2022, 59% of donors as of May 15, 2022, 70% of donors as of Aug. 15, 2022, and 78% of donors as of Nov. 15, 2022.
Donor blood also was analyzed for the presence of antibodies known to come from COVID vaccination. When the vaccine-induced and infection-induced antibody data were combined, the CDC estimated that 97% of people had antibodies as of the end of the 2022.
In the report, CDC authors explained that while the presence of antibodies is related to protection from infection and to less severe disease, the level of antibodies that a person has can vary. The authors said that no standards have yet been set that show a minimum level of antibodies needed to provide protection.
As of July 3, more than 1.1 million people had died in the United States from COVID-19, according to CDC data. Deaths for the first half of 2023 are down dramatically, compared with the first 3 years of the pandemic, with just 41,538 death certificates this year listing the virus as an underlying or contributing cause. About two in three COVID deaths this year occurred in a hospital or nursing home, and 89% of people who died from the virus this year have been age 65 or older.
A version of this article first appeared on WebMD.com.
, according to a new estimate.
The findings came from an analysis of blood donations. The Centers for Disease Control and Prevention analyzed donor blood from 143,000 people every 3 months during 2022, looking for the presence of COVID antibodies that meant a person had previously been infected with the virus. The prevalence of antibodies from previous infections steadily rose throughout the year. Antibodies from prior infection were found in 49% of donors as of Feb. 15, 2022, 59% of donors as of May 15, 2022, 70% of donors as of Aug. 15, 2022, and 78% of donors as of Nov. 15, 2022.
Donor blood also was analyzed for the presence of antibodies known to come from COVID vaccination. When the vaccine-induced and infection-induced antibody data were combined, the CDC estimated that 97% of people had antibodies as of the end of the 2022.
In the report, CDC authors explained that while the presence of antibodies is related to protection from infection and to less severe disease, the level of antibodies that a person has can vary. The authors said that no standards have yet been set that show a minimum level of antibodies needed to provide protection.
As of July 3, more than 1.1 million people had died in the United States from COVID-19, according to CDC data. Deaths for the first half of 2023 are down dramatically, compared with the first 3 years of the pandemic, with just 41,538 death certificates this year listing the virus as an underlying or contributing cause. About two in three COVID deaths this year occurred in a hospital or nursing home, and 89% of people who died from the virus this year have been age 65 or older.
A version of this article first appeared on WebMD.com.
, according to a new estimate.
The findings came from an analysis of blood donations. The Centers for Disease Control and Prevention analyzed donor blood from 143,000 people every 3 months during 2022, looking for the presence of COVID antibodies that meant a person had previously been infected with the virus. The prevalence of antibodies from previous infections steadily rose throughout the year. Antibodies from prior infection were found in 49% of donors as of Feb. 15, 2022, 59% of donors as of May 15, 2022, 70% of donors as of Aug. 15, 2022, and 78% of donors as of Nov. 15, 2022.
Donor blood also was analyzed for the presence of antibodies known to come from COVID vaccination. When the vaccine-induced and infection-induced antibody data were combined, the CDC estimated that 97% of people had antibodies as of the end of the 2022.
In the report, CDC authors explained that while the presence of antibodies is related to protection from infection and to less severe disease, the level of antibodies that a person has can vary. The authors said that no standards have yet been set that show a minimum level of antibodies needed to provide protection.
As of July 3, more than 1.1 million people had died in the United States from COVID-19, according to CDC data. Deaths for the first half of 2023 are down dramatically, compared with the first 3 years of the pandemic, with just 41,538 death certificates this year listing the virus as an underlying or contributing cause. About two in three COVID deaths this year occurred in a hospital or nursing home, and 89% of people who died from the virus this year have been age 65 or older.
A version of this article first appeared on WebMD.com.
Treating obesity: Will new drugs end the crisis?
This is the second in a three-part series on the obesity crisis. Part one tackles a complicated question – why does the obesity rate keep rising despite our efforts to stop it? – and can be found here. Part three shows how doctors and patients can make treatment better and can be found here.
In the mid-1980s, Louis J. Aronne, MD, strolled into a lab at Rockefeller University in New York where a colleague was breeding mice. “I will never forget what he showed me,” said Dr. Aronne, now the director of obesity research and treatment at Weill Cornell Medicine in New York. “He had a cage with 10 mice, one severely obese and the others normal weight. He took blood from one of the thin mice and gave it to the fat mouse.”
When Dr. Aronne returned 3 days later, that obese mouse had turned thin.
It was proof of something Dr. Aronne already suspected: Obesity had biological causes and wasn’t just a failure of willpower.
Years later, in 1994, that research led to the discovery of leptin, a hormone released from fat cells that’s involved in the regulation of body weight. It was a watershed moment in obesity research.
Since then, Dr. Aronne and others have worked to build the clinical field of obesity medicine, attempting to shift the public and medical view of obesity from a purely behavioral issue to a disease worthy of medical treatment.
All the while, the U.S. obesity rate soared.
Now, another watershed moment: We finally have highly effective obesity drugs. The hype is real, and so are the weight loss results.
“I’ve been saying for 30 years that when we find treatments that really work, people aren’t going to believe the results,” Dr. Aronne said. “It took longer than I expected, but it’s gratifying now to see.”
The big question
The emerging class of obesity medications known as GLP-1 agonists is indeed a game changer. The weight loss drug semaglutide (Ozempic, Wegovy) showed groundbreaking results, and studies suggest a parade of even more impressive drugs is on the way.
Yes, the drugs offer new hope to millions with obesity complications. But to truly turn the tide on our 42% obesity rate, much more work remains to be done, researchers said, including answering a big question:
How do these weight loss drugs work?
“We have new blockbuster drugs, and we don’t even know why they reduce body weight,” said Samuel Klein, MD, professor of medicine and nutritional science at Washington University in St. Louis. “It was by accident that this was discovered.”
Oops, we created a weight loss drug
Developed to treat diabetes, the GLP-1 drugs’ weight loss effects were a surprise. Now that those effects are confirmed, pharmaceutical companies and researchers are racing to figure out how these drugs work.
In the 1960s, scientists discovered the incretin effect – when you eat glucose (sugar), your body makes more insulin than it does if glucose is given intravenously. Glucose passes through the GI tract and the gut releases hormones that stimulate insulin secretion. It’s “essentially a feed-forward signal to your pancreas to tell it, ‘By the way, you need to be ready because there’s a bunch of glucose coming,’ ” said Randy Seeley, MD, director of the Michigan Nutrition Obesity Research Center, funded by the National Institutes of Health.
One of these hormones – or “incretins” – is GLP-1. In experiments, people with type 2 diabetes who were hooked up to GLP-1 saw their blood sugar go down.
“That led to the idea that if we could take this native hormone and make it last longer, we’d have a therapy for type 2 diabetes,” said Dr. Seeley. Thanks to a GLP-1-like compound in the saliva of the Gila monster, that idea became reality in the 2000s.
Along the way, a surprising side finding came to light: In early trials, diabetes patients on these drugs dropped weight.
Both Ozempic and Wegovy – brand names for semaglutide – are once-weekly injections (pill forms to treat obesity are on the way), but the latter is a higher dose.
“That dose results in about 40% of patients in the clinical trials achieving a 20% weight loss. We’ve just had nothing like that in terms of efficacy before,” said Dr. Seeley, who has worked with some of the drug companies (including Novo Nordisk, the maker of Ozempic and Wegovy, and Eli Lilly, maker of Mounjaro) that market the GLP-1s.
By contrast, semaglutide’s once-a-day predecessor liraglutide (Saxenda, made by Novo Nordisk) can lead to about 10% weight loss.
“And one of the ironies is, we don’t really know why,” Dr. Seeley said. “We don’t know why semaglutide is a better molecule for weight loss than liraglutide.”
Initially, scientists believed that the drugs, in addition to telling the pancreas to secrete more insulin, were also signaling the brain that you’re full. “Turns out that’s not really the way it works,” Dr. Seeley said. “GLP-1 made from your gut probably doesn’t get into your brain very much. But you make GLP-1 in your brain as well.”
For weight loss, it’s the brain’s GLP-1 system, not the gut’s, that the drugs are thought to hijack. But exactly which parts of the brain they affect and how is unknown. “That’s something lots of people are working on, including our own lab,” Dr. Seeley said. (Another surprise: The drugs may have potential as an anti-addiction treatment.)
The diabetes medication tirzepatide (Mounjaro), expected to be approved for weight loss as early as this year, is also a weekly injection, but it has a unique feature: It starts a response not just for GLP-1 but also for another incretin called GIP. Turns out, two is better than one: Trial participants on tirzepatide lost up to 22.5% of their body weight.
More of these hybrid drugs are on the way, Dr. Seeley said. In mid-stage clinical trials, the drug retatrutide, which targets three hormones, led to 24% weight loss. “The idea is the more bullets we can load into the gun, the more we can push the biology into a place where it’s easier to lose weight.”
Shifting from prevention to damage control
Less invasive and more scalable than surgery (only 1% of the eligible population gets bariatric surgery), the drugs offer doctors a safe, effective way to treat many patients with obesity. That’s cause for excitement, but concerns remain because they are expensive, costing about $800 to $1,300 per month out of pocket. Many health insurers, including Medicare, do not cover them for weight loss.
“You have this significant advance in obesity treatment, but very few will be able to access it,” said Gary Foster, PhD, adjunct professor of psychology in psychiatry at the University of Pennsylvania, Philadelphia, and chief scientific officer at WW (formerly Weight Watchers).
There is a push, including a proposed bill, to get Medicare to cover obesity medication. But given the expense of the drugs, the health economics do not support that move, according to an editorial in the New England Journal of Medicine. If Medicare were to cover obesity meds, the budget impact would likely be huge, potentially driving up premiums. If other payers followed suit, the impact could be felt across the U.S. health care system.
Other drawbacks include side effects – including nausea, diarrhea, stomach pain, and vomiting – that can be so bad that some patients can’t tolerate them.
And critically, the drugs do not deal with the root cause of the problem, said Robert Lustig, MD, an endocrinologist and pediatrician at the University of California, San Francisco, who has suggested that excess insulin is driving obesity. “No one has the disease that these drugs are treating. No one has GLP-1 deficiency. They’re bypassing the problem. They’re band-aiding the problem.”
Because the drugs work by mimicking starvation – they appear to curb hunger, so you eat less – people on them lose not just fat but also healthy lean mass, Dr. Lustig said.
Concerns about pancreatitis did not really bear out in postmarketing reports. (The drugs are still not recommended in people with pancreatitis or multiple endocrine neoplasia.) But predicting longer-term outcomes can be difficult, noted Dr. Lustig.
Then there are philosophical questions, said James Hill, PhD, director of the Nutrition Obesity Research Center at the University of Alabama at Birmingham.. “If you’re continuing to not exercise and eat not healthy foods and take a medication, is that success? Have we won when people are at a lower weight but not doing a healthy behavior?”
‘We can’t treat our way out of this’
The fact is, ending the obesity epidemic is a tall order, even for drugs as impressive as these.
“We can’t treat our way out of this,” said Jamy Ard, MD, codirector of Wake Forest Baptist Health Weight Management Center in Winston-Salem, N.C. “The treatments we have now are great, and there will be more coming. But we do need to figure out the prevention side of things.”
Dr. Seeley agreed but added that we can’t diet-and-exercise our way out either.
“There’s no switch to be flipped,” Dr. Seeley said. “If you told me we shouldn’t spend all this money on these drugs, we should spend it on prevention – great! What would we do?”
And prevention efforts won’t help the millions already living with health problems from obesity, Dr. Aronne said.
“Getting people to stop smoking prevents lung cancer. But stopping smoking doesn’t treat lung cancer,” Dr. Aronne said. “Once the physical changes occur in the lung that cause a tumor to grow, it’s too late. You have to think of obesity the same way.”
Dr. Seeley pointed out that “fearmongering” around the drugs highlights our lingering bias that obesity is a lifestyle issue that should not be medically treated.
“People say, ‘When you stop taking it, you’re going to gain the weight back,’ ” Dr. Seeley said. “There’s truth to that, but when you stop taking your hypertension medication, your blood pressure goes up. We don’t think of that as a [reason] for why you shouldn’t take your blood pressure medication. But that gets trumpeted into all these conversations about whether people [with obesity] should be treated at all.”
Like obesity, blood pressure was once thought to be a behavioral problem, Dr. Aronne said. But blood pressure meds prevent heart attacks and strokes. And it’s likely obesity meds will do the same.
One 55-year-old patient on the road to kidney failure lost weight on obesity medications, including semaglutide, Dr. Aronne said. Now, 6 years later, his kidney function is back to normal. “Normally, we think of kidney disease as irreversible,” Dr. Aronne said.
In that respect, these drugs should save money in the long run by virtue of heading off those health care costs, said Dr. Seeley, who imagines a future where obesity is not gone but better managed, like high blood pressure is now.
In the end, the drugs are another step toward what Dr. Aronne and many others have always pushed for: Treating obesity as a disease.
A version of this article originally appeared on WebMD.com.
This is the second in a three-part series on the obesity crisis. Part one tackles a complicated question – why does the obesity rate keep rising despite our efforts to stop it? – and can be found here. Part three shows how doctors and patients can make treatment better and can be found here.
In the mid-1980s, Louis J. Aronne, MD, strolled into a lab at Rockefeller University in New York where a colleague was breeding mice. “I will never forget what he showed me,” said Dr. Aronne, now the director of obesity research and treatment at Weill Cornell Medicine in New York. “He had a cage with 10 mice, one severely obese and the others normal weight. He took blood from one of the thin mice and gave it to the fat mouse.”
When Dr. Aronne returned 3 days later, that obese mouse had turned thin.
It was proof of something Dr. Aronne already suspected: Obesity had biological causes and wasn’t just a failure of willpower.
Years later, in 1994, that research led to the discovery of leptin, a hormone released from fat cells that’s involved in the regulation of body weight. It was a watershed moment in obesity research.
Since then, Dr. Aronne and others have worked to build the clinical field of obesity medicine, attempting to shift the public and medical view of obesity from a purely behavioral issue to a disease worthy of medical treatment.
All the while, the U.S. obesity rate soared.
Now, another watershed moment: We finally have highly effective obesity drugs. The hype is real, and so are the weight loss results.
“I’ve been saying for 30 years that when we find treatments that really work, people aren’t going to believe the results,” Dr. Aronne said. “It took longer than I expected, but it’s gratifying now to see.”
The big question
The emerging class of obesity medications known as GLP-1 agonists is indeed a game changer. The weight loss drug semaglutide (Ozempic, Wegovy) showed groundbreaking results, and studies suggest a parade of even more impressive drugs is on the way.
Yes, the drugs offer new hope to millions with obesity complications. But to truly turn the tide on our 42% obesity rate, much more work remains to be done, researchers said, including answering a big question:
How do these weight loss drugs work?
“We have new blockbuster drugs, and we don’t even know why they reduce body weight,” said Samuel Klein, MD, professor of medicine and nutritional science at Washington University in St. Louis. “It was by accident that this was discovered.”
Oops, we created a weight loss drug
Developed to treat diabetes, the GLP-1 drugs’ weight loss effects were a surprise. Now that those effects are confirmed, pharmaceutical companies and researchers are racing to figure out how these drugs work.
In the 1960s, scientists discovered the incretin effect – when you eat glucose (sugar), your body makes more insulin than it does if glucose is given intravenously. Glucose passes through the GI tract and the gut releases hormones that stimulate insulin secretion. It’s “essentially a feed-forward signal to your pancreas to tell it, ‘By the way, you need to be ready because there’s a bunch of glucose coming,’ ” said Randy Seeley, MD, director of the Michigan Nutrition Obesity Research Center, funded by the National Institutes of Health.
One of these hormones – or “incretins” – is GLP-1. In experiments, people with type 2 diabetes who were hooked up to GLP-1 saw their blood sugar go down.
“That led to the idea that if we could take this native hormone and make it last longer, we’d have a therapy for type 2 diabetes,” said Dr. Seeley. Thanks to a GLP-1-like compound in the saliva of the Gila monster, that idea became reality in the 2000s.
Along the way, a surprising side finding came to light: In early trials, diabetes patients on these drugs dropped weight.
Both Ozempic and Wegovy – brand names for semaglutide – are once-weekly injections (pill forms to treat obesity are on the way), but the latter is a higher dose.
“That dose results in about 40% of patients in the clinical trials achieving a 20% weight loss. We’ve just had nothing like that in terms of efficacy before,” said Dr. Seeley, who has worked with some of the drug companies (including Novo Nordisk, the maker of Ozempic and Wegovy, and Eli Lilly, maker of Mounjaro) that market the GLP-1s.
By contrast, semaglutide’s once-a-day predecessor liraglutide (Saxenda, made by Novo Nordisk) can lead to about 10% weight loss.
“And one of the ironies is, we don’t really know why,” Dr. Seeley said. “We don’t know why semaglutide is a better molecule for weight loss than liraglutide.”
Initially, scientists believed that the drugs, in addition to telling the pancreas to secrete more insulin, were also signaling the brain that you’re full. “Turns out that’s not really the way it works,” Dr. Seeley said. “GLP-1 made from your gut probably doesn’t get into your brain very much. But you make GLP-1 in your brain as well.”
For weight loss, it’s the brain’s GLP-1 system, not the gut’s, that the drugs are thought to hijack. But exactly which parts of the brain they affect and how is unknown. “That’s something lots of people are working on, including our own lab,” Dr. Seeley said. (Another surprise: The drugs may have potential as an anti-addiction treatment.)
The diabetes medication tirzepatide (Mounjaro), expected to be approved for weight loss as early as this year, is also a weekly injection, but it has a unique feature: It starts a response not just for GLP-1 but also for another incretin called GIP. Turns out, two is better than one: Trial participants on tirzepatide lost up to 22.5% of their body weight.
More of these hybrid drugs are on the way, Dr. Seeley said. In mid-stage clinical trials, the drug retatrutide, which targets three hormones, led to 24% weight loss. “The idea is the more bullets we can load into the gun, the more we can push the biology into a place where it’s easier to lose weight.”
Shifting from prevention to damage control
Less invasive and more scalable than surgery (only 1% of the eligible population gets bariatric surgery), the drugs offer doctors a safe, effective way to treat many patients with obesity. That’s cause for excitement, but concerns remain because they are expensive, costing about $800 to $1,300 per month out of pocket. Many health insurers, including Medicare, do not cover them for weight loss.
“You have this significant advance in obesity treatment, but very few will be able to access it,” said Gary Foster, PhD, adjunct professor of psychology in psychiatry at the University of Pennsylvania, Philadelphia, and chief scientific officer at WW (formerly Weight Watchers).
There is a push, including a proposed bill, to get Medicare to cover obesity medication. But given the expense of the drugs, the health economics do not support that move, according to an editorial in the New England Journal of Medicine. If Medicare were to cover obesity meds, the budget impact would likely be huge, potentially driving up premiums. If other payers followed suit, the impact could be felt across the U.S. health care system.
Other drawbacks include side effects – including nausea, diarrhea, stomach pain, and vomiting – that can be so bad that some patients can’t tolerate them.
And critically, the drugs do not deal with the root cause of the problem, said Robert Lustig, MD, an endocrinologist and pediatrician at the University of California, San Francisco, who has suggested that excess insulin is driving obesity. “No one has the disease that these drugs are treating. No one has GLP-1 deficiency. They’re bypassing the problem. They’re band-aiding the problem.”
Because the drugs work by mimicking starvation – they appear to curb hunger, so you eat less – people on them lose not just fat but also healthy lean mass, Dr. Lustig said.
Concerns about pancreatitis did not really bear out in postmarketing reports. (The drugs are still not recommended in people with pancreatitis or multiple endocrine neoplasia.) But predicting longer-term outcomes can be difficult, noted Dr. Lustig.
Then there are philosophical questions, said James Hill, PhD, director of the Nutrition Obesity Research Center at the University of Alabama at Birmingham.. “If you’re continuing to not exercise and eat not healthy foods and take a medication, is that success? Have we won when people are at a lower weight but not doing a healthy behavior?”
‘We can’t treat our way out of this’
The fact is, ending the obesity epidemic is a tall order, even for drugs as impressive as these.
“We can’t treat our way out of this,” said Jamy Ard, MD, codirector of Wake Forest Baptist Health Weight Management Center in Winston-Salem, N.C. “The treatments we have now are great, and there will be more coming. But we do need to figure out the prevention side of things.”
Dr. Seeley agreed but added that we can’t diet-and-exercise our way out either.
“There’s no switch to be flipped,” Dr. Seeley said. “If you told me we shouldn’t spend all this money on these drugs, we should spend it on prevention – great! What would we do?”
And prevention efforts won’t help the millions already living with health problems from obesity, Dr. Aronne said.
“Getting people to stop smoking prevents lung cancer. But stopping smoking doesn’t treat lung cancer,” Dr. Aronne said. “Once the physical changes occur in the lung that cause a tumor to grow, it’s too late. You have to think of obesity the same way.”
Dr. Seeley pointed out that “fearmongering” around the drugs highlights our lingering bias that obesity is a lifestyle issue that should not be medically treated.
“People say, ‘When you stop taking it, you’re going to gain the weight back,’ ” Dr. Seeley said. “There’s truth to that, but when you stop taking your hypertension medication, your blood pressure goes up. We don’t think of that as a [reason] for why you shouldn’t take your blood pressure medication. But that gets trumpeted into all these conversations about whether people [with obesity] should be treated at all.”
Like obesity, blood pressure was once thought to be a behavioral problem, Dr. Aronne said. But blood pressure meds prevent heart attacks and strokes. And it’s likely obesity meds will do the same.
One 55-year-old patient on the road to kidney failure lost weight on obesity medications, including semaglutide, Dr. Aronne said. Now, 6 years later, his kidney function is back to normal. “Normally, we think of kidney disease as irreversible,” Dr. Aronne said.
In that respect, these drugs should save money in the long run by virtue of heading off those health care costs, said Dr. Seeley, who imagines a future where obesity is not gone but better managed, like high blood pressure is now.
In the end, the drugs are another step toward what Dr. Aronne and many others have always pushed for: Treating obesity as a disease.
A version of this article originally appeared on WebMD.com.
This is the second in a three-part series on the obesity crisis. Part one tackles a complicated question – why does the obesity rate keep rising despite our efforts to stop it? – and can be found here. Part three shows how doctors and patients can make treatment better and can be found here.
In the mid-1980s, Louis J. Aronne, MD, strolled into a lab at Rockefeller University in New York where a colleague was breeding mice. “I will never forget what he showed me,” said Dr. Aronne, now the director of obesity research and treatment at Weill Cornell Medicine in New York. “He had a cage with 10 mice, one severely obese and the others normal weight. He took blood from one of the thin mice and gave it to the fat mouse.”
When Dr. Aronne returned 3 days later, that obese mouse had turned thin.
It was proof of something Dr. Aronne already suspected: Obesity had biological causes and wasn’t just a failure of willpower.
Years later, in 1994, that research led to the discovery of leptin, a hormone released from fat cells that’s involved in the regulation of body weight. It was a watershed moment in obesity research.
Since then, Dr. Aronne and others have worked to build the clinical field of obesity medicine, attempting to shift the public and medical view of obesity from a purely behavioral issue to a disease worthy of medical treatment.
All the while, the U.S. obesity rate soared.
Now, another watershed moment: We finally have highly effective obesity drugs. The hype is real, and so are the weight loss results.
“I’ve been saying for 30 years that when we find treatments that really work, people aren’t going to believe the results,” Dr. Aronne said. “It took longer than I expected, but it’s gratifying now to see.”
The big question
The emerging class of obesity medications known as GLP-1 agonists is indeed a game changer. The weight loss drug semaglutide (Ozempic, Wegovy) showed groundbreaking results, and studies suggest a parade of even more impressive drugs is on the way.
Yes, the drugs offer new hope to millions with obesity complications. But to truly turn the tide on our 42% obesity rate, much more work remains to be done, researchers said, including answering a big question:
How do these weight loss drugs work?
“We have new blockbuster drugs, and we don’t even know why they reduce body weight,” said Samuel Klein, MD, professor of medicine and nutritional science at Washington University in St. Louis. “It was by accident that this was discovered.”
Oops, we created a weight loss drug
Developed to treat diabetes, the GLP-1 drugs’ weight loss effects were a surprise. Now that those effects are confirmed, pharmaceutical companies and researchers are racing to figure out how these drugs work.
In the 1960s, scientists discovered the incretin effect – when you eat glucose (sugar), your body makes more insulin than it does if glucose is given intravenously. Glucose passes through the GI tract and the gut releases hormones that stimulate insulin secretion. It’s “essentially a feed-forward signal to your pancreas to tell it, ‘By the way, you need to be ready because there’s a bunch of glucose coming,’ ” said Randy Seeley, MD, director of the Michigan Nutrition Obesity Research Center, funded by the National Institutes of Health.
One of these hormones – or “incretins” – is GLP-1. In experiments, people with type 2 diabetes who were hooked up to GLP-1 saw their blood sugar go down.
“That led to the idea that if we could take this native hormone and make it last longer, we’d have a therapy for type 2 diabetes,” said Dr. Seeley. Thanks to a GLP-1-like compound in the saliva of the Gila monster, that idea became reality in the 2000s.
Along the way, a surprising side finding came to light: In early trials, diabetes patients on these drugs dropped weight.
Both Ozempic and Wegovy – brand names for semaglutide – are once-weekly injections (pill forms to treat obesity are on the way), but the latter is a higher dose.
“That dose results in about 40% of patients in the clinical trials achieving a 20% weight loss. We’ve just had nothing like that in terms of efficacy before,” said Dr. Seeley, who has worked with some of the drug companies (including Novo Nordisk, the maker of Ozempic and Wegovy, and Eli Lilly, maker of Mounjaro) that market the GLP-1s.
By contrast, semaglutide’s once-a-day predecessor liraglutide (Saxenda, made by Novo Nordisk) can lead to about 10% weight loss.
“And one of the ironies is, we don’t really know why,” Dr. Seeley said. “We don’t know why semaglutide is a better molecule for weight loss than liraglutide.”
Initially, scientists believed that the drugs, in addition to telling the pancreas to secrete more insulin, were also signaling the brain that you’re full. “Turns out that’s not really the way it works,” Dr. Seeley said. “GLP-1 made from your gut probably doesn’t get into your brain very much. But you make GLP-1 in your brain as well.”
For weight loss, it’s the brain’s GLP-1 system, not the gut’s, that the drugs are thought to hijack. But exactly which parts of the brain they affect and how is unknown. “That’s something lots of people are working on, including our own lab,” Dr. Seeley said. (Another surprise: The drugs may have potential as an anti-addiction treatment.)
The diabetes medication tirzepatide (Mounjaro), expected to be approved for weight loss as early as this year, is also a weekly injection, but it has a unique feature: It starts a response not just for GLP-1 but also for another incretin called GIP. Turns out, two is better than one: Trial participants on tirzepatide lost up to 22.5% of their body weight.
More of these hybrid drugs are on the way, Dr. Seeley said. In mid-stage clinical trials, the drug retatrutide, which targets three hormones, led to 24% weight loss. “The idea is the more bullets we can load into the gun, the more we can push the biology into a place where it’s easier to lose weight.”
Shifting from prevention to damage control
Less invasive and more scalable than surgery (only 1% of the eligible population gets bariatric surgery), the drugs offer doctors a safe, effective way to treat many patients with obesity. That’s cause for excitement, but concerns remain because they are expensive, costing about $800 to $1,300 per month out of pocket. Many health insurers, including Medicare, do not cover them for weight loss.
“You have this significant advance in obesity treatment, but very few will be able to access it,” said Gary Foster, PhD, adjunct professor of psychology in psychiatry at the University of Pennsylvania, Philadelphia, and chief scientific officer at WW (formerly Weight Watchers).
There is a push, including a proposed bill, to get Medicare to cover obesity medication. But given the expense of the drugs, the health economics do not support that move, according to an editorial in the New England Journal of Medicine. If Medicare were to cover obesity meds, the budget impact would likely be huge, potentially driving up premiums. If other payers followed suit, the impact could be felt across the U.S. health care system.
Other drawbacks include side effects – including nausea, diarrhea, stomach pain, and vomiting – that can be so bad that some patients can’t tolerate them.
And critically, the drugs do not deal with the root cause of the problem, said Robert Lustig, MD, an endocrinologist and pediatrician at the University of California, San Francisco, who has suggested that excess insulin is driving obesity. “No one has the disease that these drugs are treating. No one has GLP-1 deficiency. They’re bypassing the problem. They’re band-aiding the problem.”
Because the drugs work by mimicking starvation – they appear to curb hunger, so you eat less – people on them lose not just fat but also healthy lean mass, Dr. Lustig said.
Concerns about pancreatitis did not really bear out in postmarketing reports. (The drugs are still not recommended in people with pancreatitis or multiple endocrine neoplasia.) But predicting longer-term outcomes can be difficult, noted Dr. Lustig.
Then there are philosophical questions, said James Hill, PhD, director of the Nutrition Obesity Research Center at the University of Alabama at Birmingham.. “If you’re continuing to not exercise and eat not healthy foods and take a medication, is that success? Have we won when people are at a lower weight but not doing a healthy behavior?”
‘We can’t treat our way out of this’
The fact is, ending the obesity epidemic is a tall order, even for drugs as impressive as these.
“We can’t treat our way out of this,” said Jamy Ard, MD, codirector of Wake Forest Baptist Health Weight Management Center in Winston-Salem, N.C. “The treatments we have now are great, and there will be more coming. But we do need to figure out the prevention side of things.”
Dr. Seeley agreed but added that we can’t diet-and-exercise our way out either.
“There’s no switch to be flipped,” Dr. Seeley said. “If you told me we shouldn’t spend all this money on these drugs, we should spend it on prevention – great! What would we do?”
And prevention efforts won’t help the millions already living with health problems from obesity, Dr. Aronne said.
“Getting people to stop smoking prevents lung cancer. But stopping smoking doesn’t treat lung cancer,” Dr. Aronne said. “Once the physical changes occur in the lung that cause a tumor to grow, it’s too late. You have to think of obesity the same way.”
Dr. Seeley pointed out that “fearmongering” around the drugs highlights our lingering bias that obesity is a lifestyle issue that should not be medically treated.
“People say, ‘When you stop taking it, you’re going to gain the weight back,’ ” Dr. Seeley said. “There’s truth to that, but when you stop taking your hypertension medication, your blood pressure goes up. We don’t think of that as a [reason] for why you shouldn’t take your blood pressure medication. But that gets trumpeted into all these conversations about whether people [with obesity] should be treated at all.”
Like obesity, blood pressure was once thought to be a behavioral problem, Dr. Aronne said. But blood pressure meds prevent heart attacks and strokes. And it’s likely obesity meds will do the same.
One 55-year-old patient on the road to kidney failure lost weight on obesity medications, including semaglutide, Dr. Aronne said. Now, 6 years later, his kidney function is back to normal. “Normally, we think of kidney disease as irreversible,” Dr. Aronne said.
In that respect, these drugs should save money in the long run by virtue of heading off those health care costs, said Dr. Seeley, who imagines a future where obesity is not gone but better managed, like high blood pressure is now.
In the end, the drugs are another step toward what Dr. Aronne and many others have always pushed for: Treating obesity as a disease.
A version of this article originally appeared on WebMD.com.
Novel tool accurately predicts suicide after self-harm
Investigators have developed and validated a new risk calculator to help predict death by suicide in the 6-12 months after an episode of nonfatal self-harm, new research shows.
A study led by Seena Fazel, MBChB, MD, University of Oxford, England, suggests the Oxford Suicide Assessment Tool for Self-harm (OxSATS) may help guide treatment decisions and target resources to those most in need, the researchers note.
“Many tools use only simple high/low categories, whereas OxSATS includes probability scores, which align more closely with risk calculators in cardiovascular medicine, such as the Framingham Risk Score, and prognostic models in cancer medicine, which provide 5-year survival probabilities. This potentially allows OxSATS to inform clinical decision-making more directly,” Dr. Fazel told this news organization.
The findings were published online in BMJ Mental Health.
Targeted tool
Self-harm is associated with a 1-year risk of suicide that is 20 times higher than that of the general population. Given that about 16 million people self-harm annually, the impact at a population level is potentially quite large, the researchers note.
Current structured approaches to gauge suicide risk among those who have engaged in self-harm are based on tools developed for other purposes and symptom checklists. “Their poor to moderate performance is therefore not unexpected,” Dr. Fazel told this news organization.
In contrast, OxSATS was specifically developed to predict suicide mortality after self-harm.
Dr. Fazel’s group evaluated data on 53,172 Swedish individuals aged 10 years and older who sought emergency medical care after episodes of self-harm.
The development cohort included 37,523 individuals. Of these, 391 died by suicide within 12 months. The validation cohort included 15,649 individuals; of these people, 178 died by suicide within 12 months.
The final OxSATS model includes 11 predictors related to age and sex, as well as variables related to substance misuse, mental health, and treatment and history of self-harm.
“The performance of the model in external validation was good, with c-index at 6 and 12 months of 0.77,” the researchers note.
Using a cutoff threshold of 1%, the OxSATS correctly identified 68% of those who died by suicide within 6 months, while 71% of those who didn’t die were correctly classified as being at low risk. The figures for risk prediction at 12 months were 82% and 54%, respectively.
The OxSATS has been made into a simple online tool with probability scores for suicide at 6 and 12 months after an episode of self-harm, but without linkage to interventions. A tool on its own is unlikely to improve outcomes, said Dr. Fazel.
“However,” he added, “it can improve consistency in the assessment process, especially in busy clinical settings where people from different professional backgrounds and experience undertake such assessments. It can also highlight the role of modifiable risk factors and provide an opportunity to transparently discuss risk with patients and their carers.”
Valuable work
Reached for comment, Igor Galynker, MD, PhD, professor of psychiatry at the Icahn School of Medicine at Mount Sinai, New York, said that this is a “very solid study with a very large sample size and solid statistical analysis.”
Another strength of the research is the outcome of suicide death versus suicide attempt or suicidal ideation. “In that respect, it is a valuable paper,” Dr. Galynker, who directs the Mount Sinai Beth Israel Suicide Research Laboratory, told this news organization.
He noted that there are no new risk factors in the model. Rather, the model contains the typical risk factors for suicide, which include male sex, substance misuse, past suicide attempt, and psychiatric diagnosis.
“The strongest risk factor in the model is self-harm by hanging, strangulation, or suffocation, which has been shown before and is therefore unsurprising,” said Dr. Galynker.
In general, the risk factors included in the model are often part of administrative tools for suicide risk assessment, said Dr. Galynker, but the OxSATS “seems easier to use because it has 11 items only.”
Broadly speaking, individuals with mental illness and past suicide attempt, past self-harm, alcohol use, and other risk factors “should be treated proactively with suicide prevention measures,” he told this news organization.
As previously reported, Dr. Galynker and colleagues have developed the Abbreviated Suicide Crisis Syndrome Checklist (A-SCS-C), a novel tool to help identify which suicidal patients who present to the emergency department should be admitted to hospital and which patients can be safely discharged.
Funding for the study was provided by Wellcome Trust and the Swedish Research Council. Dr. Fazel and Dr. Galynker have no relevant disclosures.
A version of this article first appeared on Medscape.com.
Investigators have developed and validated a new risk calculator to help predict death by suicide in the 6-12 months after an episode of nonfatal self-harm, new research shows.
A study led by Seena Fazel, MBChB, MD, University of Oxford, England, suggests the Oxford Suicide Assessment Tool for Self-harm (OxSATS) may help guide treatment decisions and target resources to those most in need, the researchers note.
“Many tools use only simple high/low categories, whereas OxSATS includes probability scores, which align more closely with risk calculators in cardiovascular medicine, such as the Framingham Risk Score, and prognostic models in cancer medicine, which provide 5-year survival probabilities. This potentially allows OxSATS to inform clinical decision-making more directly,” Dr. Fazel told this news organization.
The findings were published online in BMJ Mental Health.
Targeted tool
Self-harm is associated with a 1-year risk of suicide that is 20 times higher than that of the general population. Given that about 16 million people self-harm annually, the impact at a population level is potentially quite large, the researchers note.
Current structured approaches to gauge suicide risk among those who have engaged in self-harm are based on tools developed for other purposes and symptom checklists. “Their poor to moderate performance is therefore not unexpected,” Dr. Fazel told this news organization.
In contrast, OxSATS was specifically developed to predict suicide mortality after self-harm.
Dr. Fazel’s group evaluated data on 53,172 Swedish individuals aged 10 years and older who sought emergency medical care after episodes of self-harm.
The development cohort included 37,523 individuals. Of these, 391 died by suicide within 12 months. The validation cohort included 15,649 individuals; of these people, 178 died by suicide within 12 months.
The final OxSATS model includes 11 predictors related to age and sex, as well as variables related to substance misuse, mental health, and treatment and history of self-harm.
“The performance of the model in external validation was good, with c-index at 6 and 12 months of 0.77,” the researchers note.
Using a cutoff threshold of 1%, the OxSATS correctly identified 68% of those who died by suicide within 6 months, while 71% of those who didn’t die were correctly classified as being at low risk. The figures for risk prediction at 12 months were 82% and 54%, respectively.
The OxSATS has been made into a simple online tool with probability scores for suicide at 6 and 12 months after an episode of self-harm, but without linkage to interventions. A tool on its own is unlikely to improve outcomes, said Dr. Fazel.
“However,” he added, “it can improve consistency in the assessment process, especially in busy clinical settings where people from different professional backgrounds and experience undertake such assessments. It can also highlight the role of modifiable risk factors and provide an opportunity to transparently discuss risk with patients and their carers.”
Valuable work
Reached for comment, Igor Galynker, MD, PhD, professor of psychiatry at the Icahn School of Medicine at Mount Sinai, New York, said that this is a “very solid study with a very large sample size and solid statistical analysis.”
Another strength of the research is the outcome of suicide death versus suicide attempt or suicidal ideation. “In that respect, it is a valuable paper,” Dr. Galynker, who directs the Mount Sinai Beth Israel Suicide Research Laboratory, told this news organization.
He noted that there are no new risk factors in the model. Rather, the model contains the typical risk factors for suicide, which include male sex, substance misuse, past suicide attempt, and psychiatric diagnosis.
“The strongest risk factor in the model is self-harm by hanging, strangulation, or suffocation, which has been shown before and is therefore unsurprising,” said Dr. Galynker.
In general, the risk factors included in the model are often part of administrative tools for suicide risk assessment, said Dr. Galynker, but the OxSATS “seems easier to use because it has 11 items only.”
Broadly speaking, individuals with mental illness and past suicide attempt, past self-harm, alcohol use, and other risk factors “should be treated proactively with suicide prevention measures,” he told this news organization.
As previously reported, Dr. Galynker and colleagues have developed the Abbreviated Suicide Crisis Syndrome Checklist (A-SCS-C), a novel tool to help identify which suicidal patients who present to the emergency department should be admitted to hospital and which patients can be safely discharged.
Funding for the study was provided by Wellcome Trust and the Swedish Research Council. Dr. Fazel and Dr. Galynker have no relevant disclosures.
A version of this article first appeared on Medscape.com.
Investigators have developed and validated a new risk calculator to help predict death by suicide in the 6-12 months after an episode of nonfatal self-harm, new research shows.
A study led by Seena Fazel, MBChB, MD, University of Oxford, England, suggests the Oxford Suicide Assessment Tool for Self-harm (OxSATS) may help guide treatment decisions and target resources to those most in need, the researchers note.
“Many tools use only simple high/low categories, whereas OxSATS includes probability scores, which align more closely with risk calculators in cardiovascular medicine, such as the Framingham Risk Score, and prognostic models in cancer medicine, which provide 5-year survival probabilities. This potentially allows OxSATS to inform clinical decision-making more directly,” Dr. Fazel told this news organization.
The findings were published online in BMJ Mental Health.
Targeted tool
Self-harm is associated with a 1-year risk of suicide that is 20 times higher than that of the general population. Given that about 16 million people self-harm annually, the impact at a population level is potentially quite large, the researchers note.
Current structured approaches to gauge suicide risk among those who have engaged in self-harm are based on tools developed for other purposes and symptom checklists. “Their poor to moderate performance is therefore not unexpected,” Dr. Fazel told this news organization.
In contrast, OxSATS was specifically developed to predict suicide mortality after self-harm.
Dr. Fazel’s group evaluated data on 53,172 Swedish individuals aged 10 years and older who sought emergency medical care after episodes of self-harm.
The development cohort included 37,523 individuals. Of these, 391 died by suicide within 12 months. The validation cohort included 15,649 individuals; of these people, 178 died by suicide within 12 months.
The final OxSATS model includes 11 predictors related to age and sex, as well as variables related to substance misuse, mental health, and treatment and history of self-harm.
“The performance of the model in external validation was good, with c-index at 6 and 12 months of 0.77,” the researchers note.
Using a cutoff threshold of 1%, the OxSATS correctly identified 68% of those who died by suicide within 6 months, while 71% of those who didn’t die were correctly classified as being at low risk. The figures for risk prediction at 12 months were 82% and 54%, respectively.
The OxSATS has been made into a simple online tool with probability scores for suicide at 6 and 12 months after an episode of self-harm, but without linkage to interventions. A tool on its own is unlikely to improve outcomes, said Dr. Fazel.
“However,” he added, “it can improve consistency in the assessment process, especially in busy clinical settings where people from different professional backgrounds and experience undertake such assessments. It can also highlight the role of modifiable risk factors and provide an opportunity to transparently discuss risk with patients and their carers.”
Valuable work
Reached for comment, Igor Galynker, MD, PhD, professor of psychiatry at the Icahn School of Medicine at Mount Sinai, New York, said that this is a “very solid study with a very large sample size and solid statistical analysis.”
Another strength of the research is the outcome of suicide death versus suicide attempt or suicidal ideation. “In that respect, it is a valuable paper,” Dr. Galynker, who directs the Mount Sinai Beth Israel Suicide Research Laboratory, told this news organization.
He noted that there are no new risk factors in the model. Rather, the model contains the typical risk factors for suicide, which include male sex, substance misuse, past suicide attempt, and psychiatric diagnosis.
“The strongest risk factor in the model is self-harm by hanging, strangulation, or suffocation, which has been shown before and is therefore unsurprising,” said Dr. Galynker.
In general, the risk factors included in the model are often part of administrative tools for suicide risk assessment, said Dr. Galynker, but the OxSATS “seems easier to use because it has 11 items only.”
Broadly speaking, individuals with mental illness and past suicide attempt, past self-harm, alcohol use, and other risk factors “should be treated proactively with suicide prevention measures,” he told this news organization.
As previously reported, Dr. Galynker and colleagues have developed the Abbreviated Suicide Crisis Syndrome Checklist (A-SCS-C), a novel tool to help identify which suicidal patients who present to the emergency department should be admitted to hospital and which patients can be safely discharged.
Funding for the study was provided by Wellcome Trust and the Swedish Research Council. Dr. Fazel and Dr. Galynker have no relevant disclosures.
A version of this article first appeared on Medscape.com.
Patient aggression against receptionists demands protocols
“I’ve been hit in the head by a walking stick,” a primary care receptionist reported.
“A mother came in and was screaming and swearing at me because she couldn’t get an appointment for her daughters,” another receptionist reported.
“I’ve had people throw a bag of syringes at me because we don’t accept syringes,” said another.
Reports such as these are part of the literature supporting a review that finds patient aggression against receptionists is a serious safety concern for primary care offices and affects delivery of health care.
The review was published online in the BMJ’s Family Medicine and Community Health journal.
“Receptionists in general practice deserve evidence-based measures to improve their working conditions and well-being,” say the authors, led by Fiona Willer, PhD, of the Centre for Community Health and Wellbeing at the University of Queensland, Brisbane, Australia.
Though the study looked primarily at European and Australian practices, physicians in the United States say the incidences are familiar.
Cause often lack of access
Dr. Willer and colleagues point out that the root cause of patient regression is typically related to operational factors, such as inefficient scheduling or lack of access to the medical providers.
“However, reception staff are placed in the unenviable position of having to deal with the aftermath of the poor function of these systems without having the status or autonomy to overhaul them,” the authors note.
Authors analyzed 20 studies on aggression against receptionists.
Among the findings:
- All studies reported that patient hostility and verbal abuse of receptionists “was a frequent, routine, and relatively unavoidable occurrence in general practice.”
- Nine studies reported acts of physical violence toward receptionists, with all reporting that physical abuse occurred much less frequently than verbal abuse.
- Some acts were very severe, including being hit, shaken, held at gunpoint, stalked, and threatened with a razorblade.
The studies also discussed ways to prevent potential aggression or react to it, including:
- Regular staff training for managing patient aggression.
- Designing clinics with “safe rooms” and “cool down” spaces.
- Providing clear acrylic shields between receptionists and patients.
- Developing formal policy/procedure/protocol/action guides relating to management of patients.
Behavior can interrupt health care delivery
Carrie Janiski, DO, regional medical director at Golden Valley Health Centers in California, who was not part of the review, said she has seen the aggressive behavior the authors document in her practice’s lobby, “including yelling, name-calling, and threatening language or physical behavior.”
The instances disrupt health care delivery to the patient, who is often in crisis, and all patients and staff in the clinic, she said.
“The patient needs help and the aggressive way they are seeking it could cause harm to others or prevent them from receiving all the help they need,” she said.
She says in practices she has worked in, some effective mitigation strategies have included open-access scheduling, increased walk-in availability for appointments, de-escalation training for front-line staff, and office and exam room layout designed for safety.
She added that incident review is important and should include a process for patient dismissal from the practice.
Dustin Arnold, DO, an internal medicine specialist and chief medical officer at UnityPoint Health-St. Luke’s Hospital, Cedar Rapids, IA, said he agrees with the authors on the urgency for action.
“This is an urgent concern for practices across the country. Your receptionist is the face of your practice, and you should invest in them,” said Dr. Arnold, who was not part of the review.
He said he has seen “verbal abuse and generalized incivility” from patients against receptionists in practices where he has worked.
He said the measure the authors list that he thinks is most effective is staff de-escalation training.
“However, the best preventative measure is for the physician to be on time and minimize cancellation of appointments,” he said. “These are the two primary triggers of a patient becoming disruptive.”
He said his practice has installed a panic button at the front desk and built an alert into the electronic health record indicating that a patient has shown disruptive behavior in the past.
The authors conclude: “Staff training and protocols to manage patient aggression and ongoing structured staff support should be considered essential in general practice. Evidence-based strategies to prevent, manage, and mitigate the harms of patient aggression towards general practice reception staff are urgently needed.”
The authors and Dr. Janiski and Dr. Arnold declared no relevant financial relationships.
“I’ve been hit in the head by a walking stick,” a primary care receptionist reported.
“A mother came in and was screaming and swearing at me because she couldn’t get an appointment for her daughters,” another receptionist reported.
“I’ve had people throw a bag of syringes at me because we don’t accept syringes,” said another.
Reports such as these are part of the literature supporting a review that finds patient aggression against receptionists is a serious safety concern for primary care offices and affects delivery of health care.
The review was published online in the BMJ’s Family Medicine and Community Health journal.
“Receptionists in general practice deserve evidence-based measures to improve their working conditions and well-being,” say the authors, led by Fiona Willer, PhD, of the Centre for Community Health and Wellbeing at the University of Queensland, Brisbane, Australia.
Though the study looked primarily at European and Australian practices, physicians in the United States say the incidences are familiar.
Cause often lack of access
Dr. Willer and colleagues point out that the root cause of patient regression is typically related to operational factors, such as inefficient scheduling or lack of access to the medical providers.
“However, reception staff are placed in the unenviable position of having to deal with the aftermath of the poor function of these systems without having the status or autonomy to overhaul them,” the authors note.
Authors analyzed 20 studies on aggression against receptionists.
Among the findings:
- All studies reported that patient hostility and verbal abuse of receptionists “was a frequent, routine, and relatively unavoidable occurrence in general practice.”
- Nine studies reported acts of physical violence toward receptionists, with all reporting that physical abuse occurred much less frequently than verbal abuse.
- Some acts were very severe, including being hit, shaken, held at gunpoint, stalked, and threatened with a razorblade.
The studies also discussed ways to prevent potential aggression or react to it, including:
- Regular staff training for managing patient aggression.
- Designing clinics with “safe rooms” and “cool down” spaces.
- Providing clear acrylic shields between receptionists and patients.
- Developing formal policy/procedure/protocol/action guides relating to management of patients.
Behavior can interrupt health care delivery
Carrie Janiski, DO, regional medical director at Golden Valley Health Centers in California, who was not part of the review, said she has seen the aggressive behavior the authors document in her practice’s lobby, “including yelling, name-calling, and threatening language or physical behavior.”
The instances disrupt health care delivery to the patient, who is often in crisis, and all patients and staff in the clinic, she said.
“The patient needs help and the aggressive way they are seeking it could cause harm to others or prevent them from receiving all the help they need,” she said.
She says in practices she has worked in, some effective mitigation strategies have included open-access scheduling, increased walk-in availability for appointments, de-escalation training for front-line staff, and office and exam room layout designed for safety.
She added that incident review is important and should include a process for patient dismissal from the practice.
Dustin Arnold, DO, an internal medicine specialist and chief medical officer at UnityPoint Health-St. Luke’s Hospital, Cedar Rapids, IA, said he agrees with the authors on the urgency for action.
“This is an urgent concern for practices across the country. Your receptionist is the face of your practice, and you should invest in them,” said Dr. Arnold, who was not part of the review.
He said he has seen “verbal abuse and generalized incivility” from patients against receptionists in practices where he has worked.
He said the measure the authors list that he thinks is most effective is staff de-escalation training.
“However, the best preventative measure is for the physician to be on time and minimize cancellation of appointments,” he said. “These are the two primary triggers of a patient becoming disruptive.”
He said his practice has installed a panic button at the front desk and built an alert into the electronic health record indicating that a patient has shown disruptive behavior in the past.
The authors conclude: “Staff training and protocols to manage patient aggression and ongoing structured staff support should be considered essential in general practice. Evidence-based strategies to prevent, manage, and mitigate the harms of patient aggression towards general practice reception staff are urgently needed.”
The authors and Dr. Janiski and Dr. Arnold declared no relevant financial relationships.
“I’ve been hit in the head by a walking stick,” a primary care receptionist reported.
“A mother came in and was screaming and swearing at me because she couldn’t get an appointment for her daughters,” another receptionist reported.
“I’ve had people throw a bag of syringes at me because we don’t accept syringes,” said another.
Reports such as these are part of the literature supporting a review that finds patient aggression against receptionists is a serious safety concern for primary care offices and affects delivery of health care.
The review was published online in the BMJ’s Family Medicine and Community Health journal.
“Receptionists in general practice deserve evidence-based measures to improve their working conditions and well-being,” say the authors, led by Fiona Willer, PhD, of the Centre for Community Health and Wellbeing at the University of Queensland, Brisbane, Australia.
Though the study looked primarily at European and Australian practices, physicians in the United States say the incidences are familiar.
Cause often lack of access
Dr. Willer and colleagues point out that the root cause of patient regression is typically related to operational factors, such as inefficient scheduling or lack of access to the medical providers.
“However, reception staff are placed in the unenviable position of having to deal with the aftermath of the poor function of these systems without having the status or autonomy to overhaul them,” the authors note.
Authors analyzed 20 studies on aggression against receptionists.
Among the findings:
- All studies reported that patient hostility and verbal abuse of receptionists “was a frequent, routine, and relatively unavoidable occurrence in general practice.”
- Nine studies reported acts of physical violence toward receptionists, with all reporting that physical abuse occurred much less frequently than verbal abuse.
- Some acts were very severe, including being hit, shaken, held at gunpoint, stalked, and threatened with a razorblade.
The studies also discussed ways to prevent potential aggression or react to it, including:
- Regular staff training for managing patient aggression.
- Designing clinics with “safe rooms” and “cool down” spaces.
- Providing clear acrylic shields between receptionists and patients.
- Developing formal policy/procedure/protocol/action guides relating to management of patients.
Behavior can interrupt health care delivery
Carrie Janiski, DO, regional medical director at Golden Valley Health Centers in California, who was not part of the review, said she has seen the aggressive behavior the authors document in her practice’s lobby, “including yelling, name-calling, and threatening language or physical behavior.”
The instances disrupt health care delivery to the patient, who is often in crisis, and all patients and staff in the clinic, she said.
“The patient needs help and the aggressive way they are seeking it could cause harm to others or prevent them from receiving all the help they need,” she said.
She says in practices she has worked in, some effective mitigation strategies have included open-access scheduling, increased walk-in availability for appointments, de-escalation training for front-line staff, and office and exam room layout designed for safety.
She added that incident review is important and should include a process for patient dismissal from the practice.
Dustin Arnold, DO, an internal medicine specialist and chief medical officer at UnityPoint Health-St. Luke’s Hospital, Cedar Rapids, IA, said he agrees with the authors on the urgency for action.
“This is an urgent concern for practices across the country. Your receptionist is the face of your practice, and you should invest in them,” said Dr. Arnold, who was not part of the review.
He said he has seen “verbal abuse and generalized incivility” from patients against receptionists in practices where he has worked.
He said the measure the authors list that he thinks is most effective is staff de-escalation training.
“However, the best preventative measure is for the physician to be on time and minimize cancellation of appointments,” he said. “These are the two primary triggers of a patient becoming disruptive.”
He said his practice has installed a panic button at the front desk and built an alert into the electronic health record indicating that a patient has shown disruptive behavior in the past.
The authors conclude: “Staff training and protocols to manage patient aggression and ongoing structured staff support should be considered essential in general practice. Evidence-based strategies to prevent, manage, and mitigate the harms of patient aggression towards general practice reception staff are urgently needed.”
The authors and Dr. Janiski and Dr. Arnold declared no relevant financial relationships.
FROM FAMILY MEDICINE AND COMMUNITY HEALTH
Malaria is spreading in the U.S. for the first time in 20 years
, the Centers for Disease Control and Prevention says.
The federal health agency recently issued a nationwide warning to health providers and officials to be on the lookout for symptoms of the potentially fatal illness. Usually, people in the U.S. who get malaria get the disease during international travel.
All five people – four in Florida and one in Texas – have received treatment and are improving, according to the CDC. The case in Texas is not related to the Florida cases, and all occurred in the past 2 months.
Malaria cannot be transmitted from person to person. It is spread by the bite of an infected female mosquito. The last cases of people being infected while in the U.S. occurred 20 years ago, when there were eight cases in Palm Beach County, Fla. The Texas Department of State Health Services said the last time malaria was locally acquired in the state was 1994.
The Florida Department of Health said it was spraying for mosquitoes in the two counties surrounding Sarasota, Fla., where the four cases occurred.
The CDC said the risk of getting malaria while in the United States “remains extremely low.” The agency advised people to protect themselves by taking precautions to prevent mosquito bites, such as wearing insect repellent and wearing long-sleeved shirts and pants. People should also do things to ensure that mosquitoes aren’t around their home, such as getting rid of standing water, which is an environment for mosquitoes to lay eggs.
More than 240 million malaria cases occur annually worldwide, the CDC said, with 95% in Africa. There are 2,000 cases diagnosed annually in the U.S. that are related to international travel. Malaria symptoms are similar to those of other illnesses and include fever, chills, a headache, and muscle aches. If not treated, malaria can be fatal.
A version of this article first appeared on WebMD.com.
, the Centers for Disease Control and Prevention says.
The federal health agency recently issued a nationwide warning to health providers and officials to be on the lookout for symptoms of the potentially fatal illness. Usually, people in the U.S. who get malaria get the disease during international travel.
All five people – four in Florida and one in Texas – have received treatment and are improving, according to the CDC. The case in Texas is not related to the Florida cases, and all occurred in the past 2 months.
Malaria cannot be transmitted from person to person. It is spread by the bite of an infected female mosquito. The last cases of people being infected while in the U.S. occurred 20 years ago, when there were eight cases in Palm Beach County, Fla. The Texas Department of State Health Services said the last time malaria was locally acquired in the state was 1994.
The Florida Department of Health said it was spraying for mosquitoes in the two counties surrounding Sarasota, Fla., where the four cases occurred.
The CDC said the risk of getting malaria while in the United States “remains extremely low.” The agency advised people to protect themselves by taking precautions to prevent mosquito bites, such as wearing insect repellent and wearing long-sleeved shirts and pants. People should also do things to ensure that mosquitoes aren’t around their home, such as getting rid of standing water, which is an environment for mosquitoes to lay eggs.
More than 240 million malaria cases occur annually worldwide, the CDC said, with 95% in Africa. There are 2,000 cases diagnosed annually in the U.S. that are related to international travel. Malaria symptoms are similar to those of other illnesses and include fever, chills, a headache, and muscle aches. If not treated, malaria can be fatal.
A version of this article first appeared on WebMD.com.
, the Centers for Disease Control and Prevention says.
The federal health agency recently issued a nationwide warning to health providers and officials to be on the lookout for symptoms of the potentially fatal illness. Usually, people in the U.S. who get malaria get the disease during international travel.
All five people – four in Florida and one in Texas – have received treatment and are improving, according to the CDC. The case in Texas is not related to the Florida cases, and all occurred in the past 2 months.
Malaria cannot be transmitted from person to person. It is spread by the bite of an infected female mosquito. The last cases of people being infected while in the U.S. occurred 20 years ago, when there were eight cases in Palm Beach County, Fla. The Texas Department of State Health Services said the last time malaria was locally acquired in the state was 1994.
The Florida Department of Health said it was spraying for mosquitoes in the two counties surrounding Sarasota, Fla., where the four cases occurred.
The CDC said the risk of getting malaria while in the United States “remains extremely low.” The agency advised people to protect themselves by taking precautions to prevent mosquito bites, such as wearing insect repellent and wearing long-sleeved shirts and pants. People should also do things to ensure that mosquitoes aren’t around their home, such as getting rid of standing water, which is an environment for mosquitoes to lay eggs.
More than 240 million malaria cases occur annually worldwide, the CDC said, with 95% in Africa. There are 2,000 cases diagnosed annually in the U.S. that are related to international travel. Malaria symptoms are similar to those of other illnesses and include fever, chills, a headache, and muscle aches. If not treated, malaria can be fatal.
A version of this article first appeared on WebMD.com.
Dangerous grandparents
Many decades ago I wrote a book I brazenly titled: “The Good Grandmother Handbook.” I had been a parent for a scant 7 or 8 years but based on my experiences in the office I felt I had accumulated enough wisdom to suggest to women in their fifth to seventh decades how they might conduct themselves around their grandchildren. Luckily, the book never got further than several hundred pages of crudely typed manuscript. This was before word processing programs had settled into the home computer industry, which was still in its infancy.
But I continue find the subject of grandparents interesting. Now, with grandchildren of my own (the oldest has just graduated from high school) and scores of peers knee deep in their own grandparenting adventures, I hope that my perspective now has a bit less of a holier-than-thou aroma.
My most recent muse-prodding event came when I stumbled across an article about the epidemiology of unintentional pediatric firearm fatalities. Looking at 10 years of data from the National Violent Death Reporting System, the investigators found that in 80% of the cases the firearm owner was a relative of the victim; in slightly more than 60% of the cases the event occurred in the victim’s home.
The data set was not granular enough to define the exact relationship between the child and relative who owned the gun. I suspect that most often the relative was a parent or an uncle or aunt. However, viewed through my septuagenarian prism, this paper prompted me to wonder in how many of these fatalities the firearm owner was a grandparent.
I have only anecdotal observations, but I can easily recall situations here in Maine in which a child has been injured by his or her grandfather’s gun. The data from the study show that pediatric fatalities are bimodal, with the majority occurring in the 1- to 5-year age group and a second peak in adolescence. The grandparent-involved cases I can recall were in the younger demographic.
Unfortunately, firearms aren’t the only threat that other grandparents and I pose to the health and safety of our grandchildren. I can remember before the development of, and the widespread use of, tamper-proof pill bottles, “grandma’s purse” overdoses were an unfortunately common occurrence.
More recently, at least here in Maine, we have been hearing more about motorized vehicle–related injuries and fatalities – grandparents backing over their grandchildren in the driveway or, more often, grandfathers (usually) taking their young grandchildren for rides on their snowmobiles, ATVs, lawn tractors, (fill in the blank). Whenever one of these events occurs, my mind quickly jumps beyond the tragic loss of life to imagining what terrible and long-lasting emotional chaos these incidents have spawned in those families.
During the pandemic, many parents and grandparents became aware of the threat that viral-spewing young children pose to the older and more vulnerable generation. On the other hand, many parents have been told that having a grandparent around can present a risk to the health and safety of their grandchildren. It can be a touchy subject in families, and grandparents may bristle at “being treated like a child” when they are reminded that children aren’t small adults and that their own behavior may be setting a bad example or putting their grandchildren at risk.
My generation had to learn how to buckle infants and toddlers into car seats because it was something that wasn’t done for our children. Fortunately, most new grandparents now already have those buckle-and-click skills and mindset. But,
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Many decades ago I wrote a book I brazenly titled: “The Good Grandmother Handbook.” I had been a parent for a scant 7 or 8 years but based on my experiences in the office I felt I had accumulated enough wisdom to suggest to women in their fifth to seventh decades how they might conduct themselves around their grandchildren. Luckily, the book never got further than several hundred pages of crudely typed manuscript. This was before word processing programs had settled into the home computer industry, which was still in its infancy.
But I continue find the subject of grandparents interesting. Now, with grandchildren of my own (the oldest has just graduated from high school) and scores of peers knee deep in their own grandparenting adventures, I hope that my perspective now has a bit less of a holier-than-thou aroma.
My most recent muse-prodding event came when I stumbled across an article about the epidemiology of unintentional pediatric firearm fatalities. Looking at 10 years of data from the National Violent Death Reporting System, the investigators found that in 80% of the cases the firearm owner was a relative of the victim; in slightly more than 60% of the cases the event occurred in the victim’s home.
The data set was not granular enough to define the exact relationship between the child and relative who owned the gun. I suspect that most often the relative was a parent or an uncle or aunt. However, viewed through my septuagenarian prism, this paper prompted me to wonder in how many of these fatalities the firearm owner was a grandparent.
I have only anecdotal observations, but I can easily recall situations here in Maine in which a child has been injured by his or her grandfather’s gun. The data from the study show that pediatric fatalities are bimodal, with the majority occurring in the 1- to 5-year age group and a second peak in adolescence. The grandparent-involved cases I can recall were in the younger demographic.
Unfortunately, firearms aren’t the only threat that other grandparents and I pose to the health and safety of our grandchildren. I can remember before the development of, and the widespread use of, tamper-proof pill bottles, “grandma’s purse” overdoses were an unfortunately common occurrence.
More recently, at least here in Maine, we have been hearing more about motorized vehicle–related injuries and fatalities – grandparents backing over their grandchildren in the driveway or, more often, grandfathers (usually) taking their young grandchildren for rides on their snowmobiles, ATVs, lawn tractors, (fill in the blank). Whenever one of these events occurs, my mind quickly jumps beyond the tragic loss of life to imagining what terrible and long-lasting emotional chaos these incidents have spawned in those families.
During the pandemic, many parents and grandparents became aware of the threat that viral-spewing young children pose to the older and more vulnerable generation. On the other hand, many parents have been told that having a grandparent around can present a risk to the health and safety of their grandchildren. It can be a touchy subject in families, and grandparents may bristle at “being treated like a child” when they are reminded that children aren’t small adults and that their own behavior may be setting a bad example or putting their grandchildren at risk.
My generation had to learn how to buckle infants and toddlers into car seats because it was something that wasn’t done for our children. Fortunately, most new grandparents now already have those buckle-and-click skills and mindset. But,
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Many decades ago I wrote a book I brazenly titled: “The Good Grandmother Handbook.” I had been a parent for a scant 7 or 8 years but based on my experiences in the office I felt I had accumulated enough wisdom to suggest to women in their fifth to seventh decades how they might conduct themselves around their grandchildren. Luckily, the book never got further than several hundred pages of crudely typed manuscript. This was before word processing programs had settled into the home computer industry, which was still in its infancy.
But I continue find the subject of grandparents interesting. Now, with grandchildren of my own (the oldest has just graduated from high school) and scores of peers knee deep in their own grandparenting adventures, I hope that my perspective now has a bit less of a holier-than-thou aroma.
My most recent muse-prodding event came when I stumbled across an article about the epidemiology of unintentional pediatric firearm fatalities. Looking at 10 years of data from the National Violent Death Reporting System, the investigators found that in 80% of the cases the firearm owner was a relative of the victim; in slightly more than 60% of the cases the event occurred in the victim’s home.
The data set was not granular enough to define the exact relationship between the child and relative who owned the gun. I suspect that most often the relative was a parent or an uncle or aunt. However, viewed through my septuagenarian prism, this paper prompted me to wonder in how many of these fatalities the firearm owner was a grandparent.
I have only anecdotal observations, but I can easily recall situations here in Maine in which a child has been injured by his or her grandfather’s gun. The data from the study show that pediatric fatalities are bimodal, with the majority occurring in the 1- to 5-year age group and a second peak in adolescence. The grandparent-involved cases I can recall were in the younger demographic.
Unfortunately, firearms aren’t the only threat that other grandparents and I pose to the health and safety of our grandchildren. I can remember before the development of, and the widespread use of, tamper-proof pill bottles, “grandma’s purse” overdoses were an unfortunately common occurrence.
More recently, at least here in Maine, we have been hearing more about motorized vehicle–related injuries and fatalities – grandparents backing over their grandchildren in the driveway or, more often, grandfathers (usually) taking their young grandchildren for rides on their snowmobiles, ATVs, lawn tractors, (fill in the blank). Whenever one of these events occurs, my mind quickly jumps beyond the tragic loss of life to imagining what terrible and long-lasting emotional chaos these incidents have spawned in those families.
During the pandemic, many parents and grandparents became aware of the threat that viral-spewing young children pose to the older and more vulnerable generation. On the other hand, many parents have been told that having a grandparent around can present a risk to the health and safety of their grandchildren. It can be a touchy subject in families, and grandparents may bristle at “being treated like a child” when they are reminded that children aren’t small adults and that their own behavior may be setting a bad example or putting their grandchildren at risk.
My generation had to learn how to buckle infants and toddlers into car seats because it was something that wasn’t done for our children. Fortunately, most new grandparents now already have those buckle-and-click skills and mindset. But,
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
New guidelines for MTX use in pediatric inflammatory skin disease unveiled
While the typical dose of methotrexate (MTX) for inflammatory disease in pediatric patients varies in published studies, the maximum dose is considered to be 1 mg/kg and not to exceed 25 mg/week. In addition, test doses are not necessary for pediatric patients starting low dose (1 mg/kg or less) MTX for inflammatory skin disease, and the onset of efficacy with MTX may take 8-16 weeks.
published online in Pediatric Dermatology.
“Methotrexate is a cost-effective, readily accessible, well-tolerated, useful, and time-honored option for children with a spectrum of inflammatory skin diseases,” project cochair Elaine C. Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University, told this news organization. “Although considered an ‘immune suppressant’ by some, it is more accurately classified as an immune modulator and has been widely used for more than 50 years, and remains the standard of care when administered at very high doses and intrathecally in children with acute lymphoblastic leukemia – a practice that supports safety. But many details that support optimized treatment are not widely appreciated.”
In their guidelines document, Dr. Siegfried and her 22 coauthors noted that Food and Drug Administration labeling does not include approved indications for the use of MTX for many inflammatory skin diseases in pediatric patients, including morphea, psoriasis, atopic dermatitis, and alopecia areata. “Furthermore, some clinicians may be unfamiliar or uncomfortable prescribing medications off label for pediatric patients, causing delayed initiation, premature drug discontinuation, or use of less advantageous alternatives,” they wrote.
To address this unmet need, Dr. Siegfried and the other committee members used a modified Delphi process to reach agreement on recommendations related to five key topic areas: indications and contraindications, dosing, interactions with immunizations and medications, potential for and management of adverse effects, and monitoring needs. Consensus was predefined as at least 70% of participants rating a statement as 7-9 on the Likert scale. The effort to develop 46 recommendations has been a work in progress for almost 5 years, “somewhat delayed by the pandemic,” Dr. Siegfried, past president and director of the American Board of Dermatology, said in an interview. “But it remains relevant, despite the emergence of biologics and JAK inhibitors for treating inflammatory skin conditions in children. Although the mechanism-of-action of low-dose MTX is not clear, it may overlap with the newer small molecules.”
The guidelines contain several pearls to guide optimal dosing, including the following key points:
- MTX can be discontinued abruptly without adverse effects, other than the risk of disease worsening.
- Folic acid supplementation (starting at 1 mg/day, regardless of weight) is an effective approach to minimizing associated gastrointestinal adverse effects.
- Concomitant use of MTX and antibiotics (including trimethoprim-sulfamethoxazole) and NSAIDS are not contraindicated for most pediatric patients treated for inflammatory skin disease.
- Live virus vaccine boosters such as varicella-zoster virus (VZV) and measles, mumps, and rubella (MMR) are not contraindicated in patients taking MTX; there are insufficient data to make recommendations for or against primary immunization with MMR vaccine in patients taking MTX; inactivated vaccines should be given to patients taking MTX.
- Routine surveillance laboratory monitoring (i.e., CBC with differential, alanine transaminase, aspartate aminotransferase, creatinine) is recommended at baseline, after 1 month of treatment, and every 3-4 months thereafter.
- Transient transaminase elevation (≤ 3 upper limit normal for < 3 months) is not uncommon with low-dose MTX and does not usually require interruption of MTX. The most likely causes are concomitant viral infection, MTX dosing within 24 hours prior to phlebotomy, recent administration of other medications (such as acetaminophen), and/or recent alcohol consumption.
- Liver biopsy is not indicated for routine monitoring of pediatric patients taking low-dose MTX.
According to Dr. Siegfried, consensus of the committee members was lowest on the need for a test dose of MTX.
Overall, she said in the interview, helping to craft the guidelines caused her to reflect on how her approach to using MTX has evolved over the past 35 years, after treating “many hundreds” of patients. “I was gratified to confirm similar practice patterns among my colleagues,” she added.
The project’s other cochair was Heather Brandling-Bennett, MD, a dermatologist at Seattle Children’s Hospital. This work was supported by a grant from the Pediatric Dermatology Research Alliance (PeDRA), with additional funding from the National Eczema Association and the National Psoriasis Foundation. Dr. Siegfried disclosed ties with AbbVie, Boehringer Ingelheim, Incyte, LEO Pharma, Novan, Novartis, Pierre Fabre, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Verrica. She has participated in contracted research for AI Therapeutics, and has served as principal investigator for Janssen. Many of the guideline coauthors disclosed having received grant support and other funding from pharmaceutical companies.
While the typical dose of methotrexate (MTX) for inflammatory disease in pediatric patients varies in published studies, the maximum dose is considered to be 1 mg/kg and not to exceed 25 mg/week. In addition, test doses are not necessary for pediatric patients starting low dose (1 mg/kg or less) MTX for inflammatory skin disease, and the onset of efficacy with MTX may take 8-16 weeks.
published online in Pediatric Dermatology.
“Methotrexate is a cost-effective, readily accessible, well-tolerated, useful, and time-honored option for children with a spectrum of inflammatory skin diseases,” project cochair Elaine C. Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University, told this news organization. “Although considered an ‘immune suppressant’ by some, it is more accurately classified as an immune modulator and has been widely used for more than 50 years, and remains the standard of care when administered at very high doses and intrathecally in children with acute lymphoblastic leukemia – a practice that supports safety. But many details that support optimized treatment are not widely appreciated.”
In their guidelines document, Dr. Siegfried and her 22 coauthors noted that Food and Drug Administration labeling does not include approved indications for the use of MTX for many inflammatory skin diseases in pediatric patients, including morphea, psoriasis, atopic dermatitis, and alopecia areata. “Furthermore, some clinicians may be unfamiliar or uncomfortable prescribing medications off label for pediatric patients, causing delayed initiation, premature drug discontinuation, or use of less advantageous alternatives,” they wrote.
To address this unmet need, Dr. Siegfried and the other committee members used a modified Delphi process to reach agreement on recommendations related to five key topic areas: indications and contraindications, dosing, interactions with immunizations and medications, potential for and management of adverse effects, and monitoring needs. Consensus was predefined as at least 70% of participants rating a statement as 7-9 on the Likert scale. The effort to develop 46 recommendations has been a work in progress for almost 5 years, “somewhat delayed by the pandemic,” Dr. Siegfried, past president and director of the American Board of Dermatology, said in an interview. “But it remains relevant, despite the emergence of biologics and JAK inhibitors for treating inflammatory skin conditions in children. Although the mechanism-of-action of low-dose MTX is not clear, it may overlap with the newer small molecules.”
The guidelines contain several pearls to guide optimal dosing, including the following key points:
- MTX can be discontinued abruptly without adverse effects, other than the risk of disease worsening.
- Folic acid supplementation (starting at 1 mg/day, regardless of weight) is an effective approach to minimizing associated gastrointestinal adverse effects.
- Concomitant use of MTX and antibiotics (including trimethoprim-sulfamethoxazole) and NSAIDS are not contraindicated for most pediatric patients treated for inflammatory skin disease.
- Live virus vaccine boosters such as varicella-zoster virus (VZV) and measles, mumps, and rubella (MMR) are not contraindicated in patients taking MTX; there are insufficient data to make recommendations for or against primary immunization with MMR vaccine in patients taking MTX; inactivated vaccines should be given to patients taking MTX.
- Routine surveillance laboratory monitoring (i.e., CBC with differential, alanine transaminase, aspartate aminotransferase, creatinine) is recommended at baseline, after 1 month of treatment, and every 3-4 months thereafter.
- Transient transaminase elevation (≤ 3 upper limit normal for < 3 months) is not uncommon with low-dose MTX and does not usually require interruption of MTX. The most likely causes are concomitant viral infection, MTX dosing within 24 hours prior to phlebotomy, recent administration of other medications (such as acetaminophen), and/or recent alcohol consumption.
- Liver biopsy is not indicated for routine monitoring of pediatric patients taking low-dose MTX.
According to Dr. Siegfried, consensus of the committee members was lowest on the need for a test dose of MTX.
Overall, she said in the interview, helping to craft the guidelines caused her to reflect on how her approach to using MTX has evolved over the past 35 years, after treating “many hundreds” of patients. “I was gratified to confirm similar practice patterns among my colleagues,” she added.
The project’s other cochair was Heather Brandling-Bennett, MD, a dermatologist at Seattle Children’s Hospital. This work was supported by a grant from the Pediatric Dermatology Research Alliance (PeDRA), with additional funding from the National Eczema Association and the National Psoriasis Foundation. Dr. Siegfried disclosed ties with AbbVie, Boehringer Ingelheim, Incyte, LEO Pharma, Novan, Novartis, Pierre Fabre, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Verrica. She has participated in contracted research for AI Therapeutics, and has served as principal investigator for Janssen. Many of the guideline coauthors disclosed having received grant support and other funding from pharmaceutical companies.
While the typical dose of methotrexate (MTX) for inflammatory disease in pediatric patients varies in published studies, the maximum dose is considered to be 1 mg/kg and not to exceed 25 mg/week. In addition, test doses are not necessary for pediatric patients starting low dose (1 mg/kg or less) MTX for inflammatory skin disease, and the onset of efficacy with MTX may take 8-16 weeks.
published online in Pediatric Dermatology.
“Methotrexate is a cost-effective, readily accessible, well-tolerated, useful, and time-honored option for children with a spectrum of inflammatory skin diseases,” project cochair Elaine C. Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University, told this news organization. “Although considered an ‘immune suppressant’ by some, it is more accurately classified as an immune modulator and has been widely used for more than 50 years, and remains the standard of care when administered at very high doses and intrathecally in children with acute lymphoblastic leukemia – a practice that supports safety. But many details that support optimized treatment are not widely appreciated.”
In their guidelines document, Dr. Siegfried and her 22 coauthors noted that Food and Drug Administration labeling does not include approved indications for the use of MTX for many inflammatory skin diseases in pediatric patients, including morphea, psoriasis, atopic dermatitis, and alopecia areata. “Furthermore, some clinicians may be unfamiliar or uncomfortable prescribing medications off label for pediatric patients, causing delayed initiation, premature drug discontinuation, or use of less advantageous alternatives,” they wrote.
To address this unmet need, Dr. Siegfried and the other committee members used a modified Delphi process to reach agreement on recommendations related to five key topic areas: indications and contraindications, dosing, interactions with immunizations and medications, potential for and management of adverse effects, and monitoring needs. Consensus was predefined as at least 70% of participants rating a statement as 7-9 on the Likert scale. The effort to develop 46 recommendations has been a work in progress for almost 5 years, “somewhat delayed by the pandemic,” Dr. Siegfried, past president and director of the American Board of Dermatology, said in an interview. “But it remains relevant, despite the emergence of biologics and JAK inhibitors for treating inflammatory skin conditions in children. Although the mechanism-of-action of low-dose MTX is not clear, it may overlap with the newer small molecules.”
The guidelines contain several pearls to guide optimal dosing, including the following key points:
- MTX can be discontinued abruptly without adverse effects, other than the risk of disease worsening.
- Folic acid supplementation (starting at 1 mg/day, regardless of weight) is an effective approach to minimizing associated gastrointestinal adverse effects.
- Concomitant use of MTX and antibiotics (including trimethoprim-sulfamethoxazole) and NSAIDS are not contraindicated for most pediatric patients treated for inflammatory skin disease.
- Live virus vaccine boosters such as varicella-zoster virus (VZV) and measles, mumps, and rubella (MMR) are not contraindicated in patients taking MTX; there are insufficient data to make recommendations for or against primary immunization with MMR vaccine in patients taking MTX; inactivated vaccines should be given to patients taking MTX.
- Routine surveillance laboratory monitoring (i.e., CBC with differential, alanine transaminase, aspartate aminotransferase, creatinine) is recommended at baseline, after 1 month of treatment, and every 3-4 months thereafter.
- Transient transaminase elevation (≤ 3 upper limit normal for < 3 months) is not uncommon with low-dose MTX and does not usually require interruption of MTX. The most likely causes are concomitant viral infection, MTX dosing within 24 hours prior to phlebotomy, recent administration of other medications (such as acetaminophen), and/or recent alcohol consumption.
- Liver biopsy is not indicated for routine monitoring of pediatric patients taking low-dose MTX.
According to Dr. Siegfried, consensus of the committee members was lowest on the need for a test dose of MTX.
Overall, she said in the interview, helping to craft the guidelines caused her to reflect on how her approach to using MTX has evolved over the past 35 years, after treating “many hundreds” of patients. “I was gratified to confirm similar practice patterns among my colleagues,” she added.
The project’s other cochair was Heather Brandling-Bennett, MD, a dermatologist at Seattle Children’s Hospital. This work was supported by a grant from the Pediatric Dermatology Research Alliance (PeDRA), with additional funding from the National Eczema Association and the National Psoriasis Foundation. Dr. Siegfried disclosed ties with AbbVie, Boehringer Ingelheim, Incyte, LEO Pharma, Novan, Novartis, Pierre Fabre, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Verrica. She has participated in contracted research for AI Therapeutics, and has served as principal investigator for Janssen. Many of the guideline coauthors disclosed having received grant support and other funding from pharmaceutical companies.
FROM PEDIATRIC DERMATOLOGY
Med students, doctor groups react to SCOTUS affirmative action ban
The U.S. Supreme Court ruled on June 29 that using race as a factor in college admissions is unconstitutional, rolling back more than 40 years of affirmative action standards and changing how medical schools evaluate applicants to attract students from diverse backgrounds.
Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, said in a prepared statement that the Supreme Court ruling will result in a less diverse physician workforce, which is “bad for health care, bad for medicine, and undermines the health of our nation.” He cited the AMA’s recent adoption of a policy advising medical schools to increase enrollment of people from racial and ethnic groups traditionally underrepresented in medicine – even if that means considering race as a factor in admissions criteria.
“Supporting racial and ethnic diversity in the health professions – spanning classrooms, labs, and clinical settings – enriches the educational experiences of all medical and health professions students and the teaching experiences of faculty, and it is essential to improving the overall health of our nation,” the Association of American Medical Colleges (AAMC) said in a prepared statement.
The American Medical Student Association also denounced the Supreme Court decision. “As future physicians committed to justice and equality, we are profoundly outraged ... We strongly support increased representation of minority students in all levels of education, including colleges and medical schools. By fostering diversity and inclusion, institutions have the power to create more empathetic and inclusive learning environments,” the organization said in a press release.
“Diversity in the health care workforce not only benefits underserved patients but improves care for all patients” by increasing understanding and empathy for people of various cultures, Omar T. Atiq, MD, president of the American College of Physicians, said in a press release.
The Supreme Court ruling stems from a lawsuit by the Students for Fair Admissions against Harvard University and the University of North Carolina. The lawsuit alleges that considering race in the college admission process constitutes discrimination and violates the Equal Protection Clause.
Chief Justice John Roberts, who delivered the court’s decision, stated that an applicant’s personal experiences should carry the most weight in admission decisions and that historically, universities have “wrongly concluded that the touchstone of an individual’s identity is not challenges bested, skills built, or lessons learned, but the color of their skin. Our constitutional history does not tolerate that choice.”
Still, Justice Roberts said the opinion does not prohibit universities from considering how race has affected an applicant’s life, “be it through discrimination, inspiration, or otherwise.”
Diversity in medical schools increased last year, with more Black, Hispanic, and female students applying and enrolling. But continued diversity efforts were expected to prove challenging with affirmative action off the table, according to an amicus brief filed last year by the AMA, the AAMC, and dozens of other professional health care organizations.
The brief supported continued use of race in college admissions, stating that eliminating that factor could slow efforts to achieve greater health equity because fewer doctors would be training and working with colleagues from diverse backgrounds.
Several universities with medical programs, such as Yale and Johns Hopkins universities, filed a separate brief citing similar concerns. After the June 29 decision, Harvard and the University of North Carolina released statements stating they would comply with the ruling.
A version of this article first appeared on Medscape.com.
The U.S. Supreme Court ruled on June 29 that using race as a factor in college admissions is unconstitutional, rolling back more than 40 years of affirmative action standards and changing how medical schools evaluate applicants to attract students from diverse backgrounds.
Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, said in a prepared statement that the Supreme Court ruling will result in a less diverse physician workforce, which is “bad for health care, bad for medicine, and undermines the health of our nation.” He cited the AMA’s recent adoption of a policy advising medical schools to increase enrollment of people from racial and ethnic groups traditionally underrepresented in medicine – even if that means considering race as a factor in admissions criteria.
“Supporting racial and ethnic diversity in the health professions – spanning classrooms, labs, and clinical settings – enriches the educational experiences of all medical and health professions students and the teaching experiences of faculty, and it is essential to improving the overall health of our nation,” the Association of American Medical Colleges (AAMC) said in a prepared statement.
The American Medical Student Association also denounced the Supreme Court decision. “As future physicians committed to justice and equality, we are profoundly outraged ... We strongly support increased representation of minority students in all levels of education, including colleges and medical schools. By fostering diversity and inclusion, institutions have the power to create more empathetic and inclusive learning environments,” the organization said in a press release.
“Diversity in the health care workforce not only benefits underserved patients but improves care for all patients” by increasing understanding and empathy for people of various cultures, Omar T. Atiq, MD, president of the American College of Physicians, said in a press release.
The Supreme Court ruling stems from a lawsuit by the Students for Fair Admissions against Harvard University and the University of North Carolina. The lawsuit alleges that considering race in the college admission process constitutes discrimination and violates the Equal Protection Clause.
Chief Justice John Roberts, who delivered the court’s decision, stated that an applicant’s personal experiences should carry the most weight in admission decisions and that historically, universities have “wrongly concluded that the touchstone of an individual’s identity is not challenges bested, skills built, or lessons learned, but the color of their skin. Our constitutional history does not tolerate that choice.”
Still, Justice Roberts said the opinion does not prohibit universities from considering how race has affected an applicant’s life, “be it through discrimination, inspiration, or otherwise.”
Diversity in medical schools increased last year, with more Black, Hispanic, and female students applying and enrolling. But continued diversity efforts were expected to prove challenging with affirmative action off the table, according to an amicus brief filed last year by the AMA, the AAMC, and dozens of other professional health care organizations.
The brief supported continued use of race in college admissions, stating that eliminating that factor could slow efforts to achieve greater health equity because fewer doctors would be training and working with colleagues from diverse backgrounds.
Several universities with medical programs, such as Yale and Johns Hopkins universities, filed a separate brief citing similar concerns. After the June 29 decision, Harvard and the University of North Carolina released statements stating they would comply with the ruling.
A version of this article first appeared on Medscape.com.
The U.S. Supreme Court ruled on June 29 that using race as a factor in college admissions is unconstitutional, rolling back more than 40 years of affirmative action standards and changing how medical schools evaluate applicants to attract students from diverse backgrounds.
Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, said in a prepared statement that the Supreme Court ruling will result in a less diverse physician workforce, which is “bad for health care, bad for medicine, and undermines the health of our nation.” He cited the AMA’s recent adoption of a policy advising medical schools to increase enrollment of people from racial and ethnic groups traditionally underrepresented in medicine – even if that means considering race as a factor in admissions criteria.
“Supporting racial and ethnic diversity in the health professions – spanning classrooms, labs, and clinical settings – enriches the educational experiences of all medical and health professions students and the teaching experiences of faculty, and it is essential to improving the overall health of our nation,” the Association of American Medical Colleges (AAMC) said in a prepared statement.
The American Medical Student Association also denounced the Supreme Court decision. “As future physicians committed to justice and equality, we are profoundly outraged ... We strongly support increased representation of minority students in all levels of education, including colleges and medical schools. By fostering diversity and inclusion, institutions have the power to create more empathetic and inclusive learning environments,” the organization said in a press release.
“Diversity in the health care workforce not only benefits underserved patients but improves care for all patients” by increasing understanding and empathy for people of various cultures, Omar T. Atiq, MD, president of the American College of Physicians, said in a press release.
The Supreme Court ruling stems from a lawsuit by the Students for Fair Admissions against Harvard University and the University of North Carolina. The lawsuit alleges that considering race in the college admission process constitutes discrimination and violates the Equal Protection Clause.
Chief Justice John Roberts, who delivered the court’s decision, stated that an applicant’s personal experiences should carry the most weight in admission decisions and that historically, universities have “wrongly concluded that the touchstone of an individual’s identity is not challenges bested, skills built, or lessons learned, but the color of their skin. Our constitutional history does not tolerate that choice.”
Still, Justice Roberts said the opinion does not prohibit universities from considering how race has affected an applicant’s life, “be it through discrimination, inspiration, or otherwise.”
Diversity in medical schools increased last year, with more Black, Hispanic, and female students applying and enrolling. But continued diversity efforts were expected to prove challenging with affirmative action off the table, according to an amicus brief filed last year by the AMA, the AAMC, and dozens of other professional health care organizations.
The brief supported continued use of race in college admissions, stating that eliminating that factor could slow efforts to achieve greater health equity because fewer doctors would be training and working with colleagues from diverse backgrounds.
Several universities with medical programs, such as Yale and Johns Hopkins universities, filed a separate brief citing similar concerns. After the June 29 decision, Harvard and the University of North Carolina released statements stating they would comply with the ruling.
A version of this article first appeared on Medscape.com.