Adolescent Medicine

Dermatologists are well aware of guidelines limiting long-term antibiotic use for acne to 3-4 months, but a perceived lack of supporting data, along with in-office realities unaddressed by guidelines, hinder clinicians’ ability and willingness to follow them, according to the authors of a recently published study.

“This study explored why dermatologists still prescribe a good number of long-term antibiotics for people with acne,” the study’s senior author Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, said in an interview. “And we found a lot of reasons.” The study was published online in JAMA Dermatology.

Yeung_Howa_ATLANTA_2022_web.jpg

Using online surveys and semi-structured video interviews of 30 dermatologists, infectious disease physicians with expertise in antimicrobial stewardship, dermatology residents, and nonphysician clinicians, the investigators assessed respondents’ knowledge and attitudes regarding long-term antibiotics in acne. Salient themes impacting long-term antibiotic prescriptions included the following:

• A perceived dearth of evidence to justify changes in practice.
• Difficulties with iPLEDGE, the Risk Evaluation and Mitigation Strategy (REMS) for managing the teratogenic risks associated with isotretinoin, and with discussing oral contraceptives.
• “Navigating” discussions with about tapering-off of antibiotics.
• Challenging patient demands.
• A lack of effective tools for monitoring progress in antibiotic stewardship.

“It’s surprising there are so many barriers that make it difficult for dermatologists to stick with the guidelines even if they want to,” said Dr. Yeung, a coauthor of the recently released updated American Academy of Dermatology (AAD) acne management guidelines.

A dermatologist who wants to stop systemic antibiotics within 3 months may not know how to do so, he explained, or high demand for appointments may prevent timely follow-ups.

A major reason why dermatologists struggle to limit long-term antibiotic use is that there are very few substitutes that are perceived to work as well, said David J. Margolis, MD, PhD, who was not involved with the study and was asked to comment on the results. He is professor of epidemiology and dermatology at the University of Pennsylvania, Philadelphia.

Margolis_David_J_PA_web.jpg

“Part of the reason antibiotics are being used to treat acne is that they’re effective, and effective for severe disease,” he said. The alternatives, which are mostly topicals, said Dr. Margolis, do not work as well for moderate to severe disease or, with isotretinoin, involve time-consuming hurdles. Dr. Margolis said that he often hears such concerns from individual dermatologists. “But it’s helpful to see these in a well-organized, well-reported qualitative study.”

Infectious disease specialists surveyed considered limiting long-term antibiotic use as extremely important, while several dermatologists “argued that other specialties ‘underestimate the impact acne has on people’s lives,’ ” the authors wrote. Other respondents prioritized making the right choice for the patient at hand.

Although guidelines were never meant to be black and white, Dr. Yeung said, it is crucial to target the goal of tapering off after about 3-4 months — a cutoff with which guidelines from groups including the AAD, the Japanese Dermatological Association in guidelines from 2016, and 2017, respectively, and others concur.

He added, “Some folks believe that if the oral antibiotic is working, why stop? We need to develop evidence to show that reducing oral antibiotic use is important to our patients, not just to a theoretical problem of antibiotic resistance in society.” For example, in a study published in The Lancet in 2004, patients who used strictly topical regimens achieved efficacy similar to that of those who used only oral antibiotics.

[embed:render:related:node:268230]

In addition, some clinicians worried that limiting antibiotics could reduce patient satisfaction, spurring switches to other providers. However, he and the other authors of the JAMA Dermatology study noted that in a survey of patients with acne published in the Journal of Clinical and Aesthetic Dermatology in 2019, 76.9% said they would be “very or extremely likely” to use effective antibiotic-free treatments if offered.

Because most respondents were highly aware of the importance of antibiotic stewardship, Dr. Yeung said, additional passive education is not necessarily the answer. “It will take a concerted effort by our national societies to come up with resources and solutions for individual dermatologists to overcome some of these larger barriers.” Such solutions could range from training in communication and shared decision-making to implementing systems that provide individualized feedback to support antibiotic stewardship.

Many ongoing studies are examining antibiotic stewardship, Dr. Margolis said in the interview. However, he added, dermatologists’ idea of long-term use is 3 months, versus 1 month or less in other specialties. “Moreover, dermatology patients tend to be much healthier individuals and are rarely hospitalized, so there may be some issues comparing the ongoing studies to individuals with acne.” Future research will need to account for such differences, he said.

The study was funded by an American Acne & Rosacea Society Clinical Research Award. Dr. Yeung is associate editor of JAMA Dermatology. Dr. Margolis has received a National Institutes of Health grant to study doxycycline versus spironolactone in acne.

Dermatologists are well aware of guidelines limiting long-term antibiotic use for acne to 3-4 months, but a perceived lack of supporting data, along with in-office realities unaddressed by guidelines, hinder clinicians’ ability and willingness to follow them, according to the authors of a recently published study.

“This study explored why dermatologists still prescribe a good number of long-term antibiotics for people with acne,” the study’s senior author Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, said in an interview. “And we found a lot of reasons.” The study was published online in JAMA Dermatology.

Yeung_Howa_ATLANTA_2022_web.jpg

Using online surveys and semi-structured video interviews of 30 dermatologists, infectious disease physicians with expertise in antimicrobial stewardship, dermatology residents, and nonphysician clinicians, the investigators assessed respondents’ knowledge and attitudes regarding long-term antibiotics in acne. Salient themes impacting long-term antibiotic prescriptions included the following:

• A perceived dearth of evidence to justify changes in practice.
• Difficulties with iPLEDGE, the Risk Evaluation and Mitigation Strategy (REMS) for managing the teratogenic risks associated with isotretinoin, and with discussing oral contraceptives.
• “Navigating” discussions with about tapering-off of antibiotics.
• Challenging patient demands.
• A lack of effective tools for monitoring progress in antibiotic stewardship.

“It’s surprising there are so many barriers that make it difficult for dermatologists to stick with the guidelines even if they want to,” said Dr. Yeung, a coauthor of the recently released updated American Academy of Dermatology (AAD) acne management guidelines.

A dermatologist who wants to stop systemic antibiotics within 3 months may not know how to do so, he explained, or high demand for appointments may prevent timely follow-ups.

A major reason why dermatologists struggle to limit long-term antibiotic use is that there are very few substitutes that are perceived to work as well, said David J. Margolis, MD, PhD, who was not involved with the study and was asked to comment on the results. He is professor of epidemiology and dermatology at the University of Pennsylvania, Philadelphia.

Margolis_David_J_PA_web.jpg

“Part of the reason antibiotics are being used to treat acne is that they’re effective, and effective for severe disease,” he said. The alternatives, which are mostly topicals, said Dr. Margolis, do not work as well for moderate to severe disease or, with isotretinoin, involve time-consuming hurdles. Dr. Margolis said that he often hears such concerns from individual dermatologists. “But it’s helpful to see these in a well-organized, well-reported qualitative study.”

Infectious disease specialists surveyed considered limiting long-term antibiotic use as extremely important, while several dermatologists “argued that other specialties ‘underestimate the impact acne has on people’s lives,’ ” the authors wrote. Other respondents prioritized making the right choice for the patient at hand.

Although guidelines were never meant to be black and white, Dr. Yeung said, it is crucial to target the goal of tapering off after about 3-4 months — a cutoff with which guidelines from groups including the AAD, the Japanese Dermatological Association in guidelines from 2016, and 2017, respectively, and others concur.

He added, “Some folks believe that if the oral antibiotic is working, why stop? We need to develop evidence to show that reducing oral antibiotic use is important to our patients, not just to a theoretical problem of antibiotic resistance in society.” For example, in a study published in The Lancet in 2004, patients who used strictly topical regimens achieved efficacy similar to that of those who used only oral antibiotics.

[embed:render:related:node:268230]

In addition, some clinicians worried that limiting antibiotics could reduce patient satisfaction, spurring switches to other providers. However, he and the other authors of the JAMA Dermatology study noted that in a survey of patients with acne published in the Journal of Clinical and Aesthetic Dermatology in 2019, 76.9% said they would be “very or extremely likely” to use effective antibiotic-free treatments if offered.

Because most respondents were highly aware of the importance of antibiotic stewardship, Dr. Yeung said, additional passive education is not necessarily the answer. “It will take a concerted effort by our national societies to come up with resources and solutions for individual dermatologists to overcome some of these larger barriers.” Such solutions could range from training in communication and shared decision-making to implementing systems that provide individualized feedback to support antibiotic stewardship.

Many ongoing studies are examining antibiotic stewardship, Dr. Margolis said in the interview. However, he added, dermatologists’ idea of long-term use is 3 months, versus 1 month or less in other specialties. “Moreover, dermatology patients tend to be much healthier individuals and are rarely hospitalized, so there may be some issues comparing the ongoing studies to individuals with acne.” Future research will need to account for such differences, he said.

The study was funded by an American Acne & Rosacea Society Clinical Research Award. Dr. Yeung is associate editor of JAMA Dermatology. Dr. Margolis has received a National Institutes of Health grant to study doxycycline versus spironolactone in acne.

Dermatologists are well aware of guidelines limiting long-term antibiotic use for acne to 3-4 months, but a perceived lack of supporting data, along with in-office realities unaddressed by guidelines, hinder clinicians’ ability and willingness to follow them, according to the authors of a recently published study.

“This study explored why dermatologists still prescribe a good number of long-term antibiotics for people with acne,” the study’s senior author Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, said in an interview. “And we found a lot of reasons.” The study was published online in JAMA Dermatology.

Yeung_Howa_ATLANTA_2022_web.jpg

Using online surveys and semi-structured video interviews of 30 dermatologists, infectious disease physicians with expertise in antimicrobial stewardship, dermatology residents, and nonphysician clinicians, the investigators assessed respondents’ knowledge and attitudes regarding long-term antibiotics in acne. Salient themes impacting long-term antibiotic prescriptions included the following:

• A perceived dearth of evidence to justify changes in practice.
• Difficulties with iPLEDGE, the Risk Evaluation and Mitigation Strategy (REMS) for managing the teratogenic risks associated with isotretinoin, and with discussing oral contraceptives.
• “Navigating” discussions with about tapering-off of antibiotics.
• Challenging patient demands.
• A lack of effective tools for monitoring progress in antibiotic stewardship.

“It’s surprising there are so many barriers that make it difficult for dermatologists to stick with the guidelines even if they want to,” said Dr. Yeung, a coauthor of the recently released updated American Academy of Dermatology (AAD) acne management guidelines.

A dermatologist who wants to stop systemic antibiotics within 3 months may not know how to do so, he explained, or high demand for appointments may prevent timely follow-ups.

A major reason why dermatologists struggle to limit long-term antibiotic use is that there are very few substitutes that are perceived to work as well, said David J. Margolis, MD, PhD, who was not involved with the study and was asked to comment on the results. He is professor of epidemiology and dermatology at the University of Pennsylvania, Philadelphia.

Margolis_David_J_PA_web.jpg

“Part of the reason antibiotics are being used to treat acne is that they’re effective, and effective for severe disease,” he said. The alternatives, which are mostly topicals, said Dr. Margolis, do not work as well for moderate to severe disease or, with isotretinoin, involve time-consuming hurdles. Dr. Margolis said that he often hears such concerns from individual dermatologists. “But it’s helpful to see these in a well-organized, well-reported qualitative study.”

Infectious disease specialists surveyed considered limiting long-term antibiotic use as extremely important, while several dermatologists “argued that other specialties ‘underestimate the impact acne has on people’s lives,’ ” the authors wrote. Other respondents prioritized making the right choice for the patient at hand.

Although guidelines were never meant to be black and white, Dr. Yeung said, it is crucial to target the goal of tapering off after about 3-4 months — a cutoff with which guidelines from groups including the AAD, the Japanese Dermatological Association in guidelines from 2016, and 2017, respectively, and others concur.

He added, “Some folks believe that if the oral antibiotic is working, why stop? We need to develop evidence to show that reducing oral antibiotic use is important to our patients, not just to a theoretical problem of antibiotic resistance in society.” For example, in a study published in The Lancet in 2004, patients who used strictly topical regimens achieved efficacy similar to that of those who used only oral antibiotics.

[embed:render:related:node:268230]

In addition, some clinicians worried that limiting antibiotics could reduce patient satisfaction, spurring switches to other providers. However, he and the other authors of the JAMA Dermatology study noted that in a survey of patients with acne published in the Journal of Clinical and Aesthetic Dermatology in 2019, 76.9% said they would be “very or extremely likely” to use effective antibiotic-free treatments if offered.

Because most respondents were highly aware of the importance of antibiotic stewardship, Dr. Yeung said, additional passive education is not necessarily the answer. “It will take a concerted effort by our national societies to come up with resources and solutions for individual dermatologists to overcome some of these larger barriers.” Such solutions could range from training in communication and shared decision-making to implementing systems that provide individualized feedback to support antibiotic stewardship.

Many ongoing studies are examining antibiotic stewardship, Dr. Margolis said in the interview. However, he added, dermatologists’ idea of long-term use is 3 months, versus 1 month or less in other specialties. “Moreover, dermatology patients tend to be much healthier individuals and are rarely hospitalized, so there may be some issues comparing the ongoing studies to individuals with acne.” Future research will need to account for such differences, he said.

The study was funded by an American Acne & Rosacea Society Clinical Research Award. Dr. Yeung is associate editor of JAMA Dermatology. Dr. Margolis has received a National Institutes of Health grant to study doxycycline versus spironolactone in acne.

TOPLINE:

Despite a high frequency of atypical features, longitudinal melanonychia (LM) in children is associated with an exceedingly low rate of malignancy.

METHODOLOGY:

• LM — a pigmented band in the nail plate caused by increased melanin deposition — occurs in children and adults, resulting from melanocytic activation or proliferation in response to infection, systemic disease, medication, trauma, and other factors.
• Clinical features of LM in children mimic red-flag signs of subungual melanoma in adults although rarely is subungual melanoma.
• A biopsy can confirm the diagnosis, but other considerations include the scar, cost and stress of a procedure, and possibly pain or deformity.
• The researchers conducted a systematic review and meta-analysis of the prevalence of clinical and dermoscopic features in 1391 pediatric patients with LM (diagnosed at a mean age of 5-13 years) from 24 studies published between 1996 and 2023.

TAKEAWAY:

• Of 731 lesions in which a diagnosis was provided, benign nail matrix nevus accounted for 86% of cases.
• Only eight cases of subungual melanoma in situ were diagnosed, with no cases of invasive melanoma identified.
• Most lesions occurred on the fingernails (76%), particularly in the first digits (45%), and the most frequent clinical features included dark-colored bands (70%), multicolored bands (48%), broad bandwidth (41%), and pseudo-Hutchinson sign (41%).
• During a median follow-up of 1-5.5 years, 30% of lesions continued to evolve with changes in width or color, while 23% remained stable and 20% underwent spontaneous regression.

IN PRACTICE:

“In the pivotal clinical decision of whether to biopsy a child with longitudinal melanonychia, perhaps with features that would require a prompt biopsy in an adult, this study provides data to support the option of clinical monitoring,” the authors wrote.

[embed:render:related:node:261286]

SOURCE:

The meta-analysis, led by Serena Yun-Chen Tsai, MD, in the Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts, was published online in Pediatric Dermatology.

LIMITATIONS:

Most studies were conducted in Asia, and data stratified by skin type were limited. Inconsistent reporting and missing critical features could affect data quality. Also, certain features displayed high heterogeneity.

DISCLOSURES:

This meta-analysis was supported by the Pediatric Dermatology Research Alliance Career Bridge Research Grant. One co-author disclosed relationships with UpToDate (author, reviewer), Skin Analytics (consultant), and DermTech (research materials).

A version of this article appeared on Medscape.com.

TOPLINE:

Despite a high frequency of atypical features, longitudinal melanonychia (LM) in children is associated with an exceedingly low rate of malignancy.

METHODOLOGY:

• LM — a pigmented band in the nail plate caused by increased melanin deposition — occurs in children and adults, resulting from melanocytic activation or proliferation in response to infection, systemic disease, medication, trauma, and other factors.
• Clinical features of LM in children mimic red-flag signs of subungual melanoma in adults although rarely is subungual melanoma.
• A biopsy can confirm the diagnosis, but other considerations include the scar, cost and stress of a procedure, and possibly pain or deformity.
• The researchers conducted a systematic review and meta-analysis of the prevalence of clinical and dermoscopic features in 1391 pediatric patients with LM (diagnosed at a mean age of 5-13 years) from 24 studies published between 1996 and 2023.

TAKEAWAY:

• Of 731 lesions in which a diagnosis was provided, benign nail matrix nevus accounted for 86% of cases.
• Only eight cases of subungual melanoma in situ were diagnosed, with no cases of invasive melanoma identified.
• Most lesions occurred on the fingernails (76%), particularly in the first digits (45%), and the most frequent clinical features included dark-colored bands (70%), multicolored bands (48%), broad bandwidth (41%), and pseudo-Hutchinson sign (41%).
• During a median follow-up of 1-5.5 years, 30% of lesions continued to evolve with changes in width or color, while 23% remained stable and 20% underwent spontaneous regression.

IN PRACTICE:

“In the pivotal clinical decision of whether to biopsy a child with longitudinal melanonychia, perhaps with features that would require a prompt biopsy in an adult, this study provides data to support the option of clinical monitoring,” the authors wrote.

[embed:render:related:node:261286]

SOURCE:

The meta-analysis, led by Serena Yun-Chen Tsai, MD, in the Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts, was published online in Pediatric Dermatology.

LIMITATIONS:

Most studies were conducted in Asia, and data stratified by skin type were limited. Inconsistent reporting and missing critical features could affect data quality. Also, certain features displayed high heterogeneity.

DISCLOSURES:

This meta-analysis was supported by the Pediatric Dermatology Research Alliance Career Bridge Research Grant. One co-author disclosed relationships with UpToDate (author, reviewer), Skin Analytics (consultant), and DermTech (research materials).

A version of this article appeared on Medscape.com.

TOPLINE:

Despite a high frequency of atypical features, longitudinal melanonychia (LM) in children is associated with an exceedingly low rate of malignancy.

METHODOLOGY:

• LM — a pigmented band in the nail plate caused by increased melanin deposition — occurs in children and adults, resulting from melanocytic activation or proliferation in response to infection, systemic disease, medication, trauma, and other factors.
• Clinical features of LM in children mimic red-flag signs of subungual melanoma in adults although rarely is subungual melanoma.
• A biopsy can confirm the diagnosis, but other considerations include the scar, cost and stress of a procedure, and possibly pain or deformity.
• The researchers conducted a systematic review and meta-analysis of the prevalence of clinical and dermoscopic features in 1391 pediatric patients with LM (diagnosed at a mean age of 5-13 years) from 24 studies published between 1996 and 2023.

TAKEAWAY:

• Of 731 lesions in which a diagnosis was provided, benign nail matrix nevus accounted for 86% of cases.
• Only eight cases of subungual melanoma in situ were diagnosed, with no cases of invasive melanoma identified.
• Most lesions occurred on the fingernails (76%), particularly in the first digits (45%), and the most frequent clinical features included dark-colored bands (70%), multicolored bands (48%), broad bandwidth (41%), and pseudo-Hutchinson sign (41%).
• During a median follow-up of 1-5.5 years, 30% of lesions continued to evolve with changes in width or color, while 23% remained stable and 20% underwent spontaneous regression.

IN PRACTICE:

“In the pivotal clinical decision of whether to biopsy a child with longitudinal melanonychia, perhaps with features that would require a prompt biopsy in an adult, this study provides data to support the option of clinical monitoring,” the authors wrote.

[embed:render:related:node:261286]

SOURCE:

The meta-analysis, led by Serena Yun-Chen Tsai, MD, in the Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts, was published online in Pediatric Dermatology.

LIMITATIONS:

Most studies were conducted in Asia, and data stratified by skin type were limited. Inconsistent reporting and missing critical features could affect data quality. Also, certain features displayed high heterogeneity.

DISCLOSURES:

This meta-analysis was supported by the Pediatric Dermatology Research Alliance Career Bridge Research Grant. One co-author disclosed relationships with UpToDate (author, reviewer), Skin Analytics (consultant), and DermTech (research materials).

A version of this article appeared on Medscape.com.

One in three Black men in rural America experienced suicidal or death ideation (SDI) in the past week, new research showed.

A developmental model used in the study showed a direct association between experiences pertaining to threat, deprivation, and racial discrimination during childhood and suicide risk in adulthood, suggesting that a broad range of adverse experiences in early life may affect SDI risk among Black men.

“During the past 20-30 years, young Black men have evinced increasing levels of suicidal behavior and related cognitions,” lead author Steven Kogan, PhD, professor of family and consumer sciences at the University of Georgia, Athens, Georgia, and colleagues wrote.

“By controlling for depressive symptoms in assessing increases in SDI over time, our study’s design directly informed the extent to which social adversities affect SDI independent of other depressive problems,” they added.

The findings were published online in Cultural Diversity and Ethnic Minority Psychology.
 

Second Leading Cause of Death

Suicide is the second leading cause of death for Black Americans ages 15-24, according to the Centers for Disease Control and Prevention. The outlook is worse for Black men, whose death rate from suicide is about four times greater than for Black women.

Previous research suggests Black men are disproportionately exposed to social adversity, including poverty and discrimination, which may increase the risk for SDI. In addition, racial discrimination has been shown to increase the risks for depression, anxiety, and psychological distress among Black youth and adults.

But little research exists to better understand how these negative experiences affect vulnerability to SDI. The new study tested a model linking adversity during childhood and emerging exposure to racial discrimination to increases in suicidal thoughts.

Researchers analyzed data from 504 participants in the African American Men’s Project, which included a series of surveys completed by young men in rural Georgia at three different time points over a period of about 3 years.

Composite scores for childhood threat and deprivation were developed using the Adverse Childhood Experiences Scale and Childhood Trauma Questionnaire. Everyday discrimination was measured on the Schedule of Racist Events response scale.

To assess their experience with childhood threats, the men in the study, who were about 21 years old on average when they enrolled, were asked if they experienced a series of adverse childhood experiences and deprivation through age 16. Questions explored issues such as directly experiencing physical violence or witnessing abuse in the home and whether the men felt loved and “important or special” as children.

The investigators also asked the men about their experiences of racial discrimination, the quality of their relationships, their belief that aggression is a means of gaining respect, and their cynicism regarding romantic relationships.
 

Targeted Prevention

Overall, 33.6% of participants reported SDI in the previous week. A history of childhood threats and deprivation was associated with an increased likelihood of SDI (P < .001).

Researchers also found that a history of racial discrimination was significantly associated with the development of negative relational schemas, which are characterized by beliefs that other people are untrustworthy, uncaring, and/or hostile. Negative schemas were in turn associated with an increased risk for suicidal thoughts (P = .03).

“Clinical and preventive interventions for suicidality should target the influence of racism and adverse experiences and the negative relational schemas they induce,” the investigators noted.

“Policy efforts designed to dismantle systemic racism are critically needed. Interventions that address SDI, including programming designed to support Black men through their experiences with racial discrimination and processing of childhood experiences of adversity, may help young Black men resist the psychological impacts of racism, expand their positive support networks, and decrease their risk of SDI,” they added.

The study authors reported no funding sources or relevant financial relationships.

A version of this article appeared on Medscape.com.

One in three Black men in rural America experienced suicidal or death ideation (SDI) in the past week, new research showed.

A developmental model used in the study showed a direct association between experiences pertaining to threat, deprivation, and racial discrimination during childhood and suicide risk in adulthood, suggesting that a broad range of adverse experiences in early life may affect SDI risk among Black men.

“During the past 20-30 years, young Black men have evinced increasing levels of suicidal behavior and related cognitions,” lead author Steven Kogan, PhD, professor of family and consumer sciences at the University of Georgia, Athens, Georgia, and colleagues wrote.

“By controlling for depressive symptoms in assessing increases in SDI over time, our study’s design directly informed the extent to which social adversities affect SDI independent of other depressive problems,” they added.

The findings were published online in Cultural Diversity and Ethnic Minority Psychology.
 

Second Leading Cause of Death

Suicide is the second leading cause of death for Black Americans ages 15-24, according to the Centers for Disease Control and Prevention. The outlook is worse for Black men, whose death rate from suicide is about four times greater than for Black women.

Previous research suggests Black men are disproportionately exposed to social adversity, including poverty and discrimination, which may increase the risk for SDI. In addition, racial discrimination has been shown to increase the risks for depression, anxiety, and psychological distress among Black youth and adults.

But little research exists to better understand how these negative experiences affect vulnerability to SDI. The new study tested a model linking adversity during childhood and emerging exposure to racial discrimination to increases in suicidal thoughts.

Researchers analyzed data from 504 participants in the African American Men’s Project, which included a series of surveys completed by young men in rural Georgia at three different time points over a period of about 3 years.

Composite scores for childhood threat and deprivation were developed using the Adverse Childhood Experiences Scale and Childhood Trauma Questionnaire. Everyday discrimination was measured on the Schedule of Racist Events response scale.

To assess their experience with childhood threats, the men in the study, who were about 21 years old on average when they enrolled, were asked if they experienced a series of adverse childhood experiences and deprivation through age 16. Questions explored issues such as directly experiencing physical violence or witnessing abuse in the home and whether the men felt loved and “important or special” as children.

The investigators also asked the men about their experiences of racial discrimination, the quality of their relationships, their belief that aggression is a means of gaining respect, and their cynicism regarding romantic relationships.
 

Targeted Prevention

Overall, 33.6% of participants reported SDI in the previous week. A history of childhood threats and deprivation was associated with an increased likelihood of SDI (P < .001).

Researchers also found that a history of racial discrimination was significantly associated with the development of negative relational schemas, which are characterized by beliefs that other people are untrustworthy, uncaring, and/or hostile. Negative schemas were in turn associated with an increased risk for suicidal thoughts (P = .03).

“Clinical and preventive interventions for suicidality should target the influence of racism and adverse experiences and the negative relational schemas they induce,” the investigators noted.

“Policy efforts designed to dismantle systemic racism are critically needed. Interventions that address SDI, including programming designed to support Black men through their experiences with racial discrimination and processing of childhood experiences of adversity, may help young Black men resist the psychological impacts of racism, expand their positive support networks, and decrease their risk of SDI,” they added.

The study authors reported no funding sources or relevant financial relationships.

A version of this article appeared on Medscape.com.

One in three Black men in rural America experienced suicidal or death ideation (SDI) in the past week, new research showed.

A developmental model used in the study showed a direct association between experiences pertaining to threat, deprivation, and racial discrimination during childhood and suicide risk in adulthood, suggesting that a broad range of adverse experiences in early life may affect SDI risk among Black men.

“During the past 20-30 years, young Black men have evinced increasing levels of suicidal behavior and related cognitions,” lead author Steven Kogan, PhD, professor of family and consumer sciences at the University of Georgia, Athens, Georgia, and colleagues wrote.

“By controlling for depressive symptoms in assessing increases in SDI over time, our study’s design directly informed the extent to which social adversities affect SDI independent of other depressive problems,” they added.

The findings were published online in Cultural Diversity and Ethnic Minority Psychology.
 

Second Leading Cause of Death

Suicide is the second leading cause of death for Black Americans ages 15-24, according to the Centers for Disease Control and Prevention. The outlook is worse for Black men, whose death rate from suicide is about four times greater than for Black women.

Previous research suggests Black men are disproportionately exposed to social adversity, including poverty and discrimination, which may increase the risk for SDI. In addition, racial discrimination has been shown to increase the risks for depression, anxiety, and psychological distress among Black youth and adults.

But little research exists to better understand how these negative experiences affect vulnerability to SDI. The new study tested a model linking adversity during childhood and emerging exposure to racial discrimination to increases in suicidal thoughts.

Researchers analyzed data from 504 participants in the African American Men’s Project, which included a series of surveys completed by young men in rural Georgia at three different time points over a period of about 3 years.

Composite scores for childhood threat and deprivation were developed using the Adverse Childhood Experiences Scale and Childhood Trauma Questionnaire. Everyday discrimination was measured on the Schedule of Racist Events response scale.

To assess their experience with childhood threats, the men in the study, who were about 21 years old on average when they enrolled, were asked if they experienced a series of adverse childhood experiences and deprivation through age 16. Questions explored issues such as directly experiencing physical violence or witnessing abuse in the home and whether the men felt loved and “important or special” as children.

The investigators also asked the men about their experiences of racial discrimination, the quality of their relationships, their belief that aggression is a means of gaining respect, and their cynicism regarding romantic relationships.
 

Targeted Prevention

Overall, 33.6% of participants reported SDI in the previous week. A history of childhood threats and deprivation was associated with an increased likelihood of SDI (P < .001).

Researchers also found that a history of racial discrimination was significantly associated with the development of negative relational schemas, which are characterized by beliefs that other people are untrustworthy, uncaring, and/or hostile. Negative schemas were in turn associated with an increased risk for suicidal thoughts (P = .03).

“Clinical and preventive interventions for suicidality should target the influence of racism and adverse experiences and the negative relational schemas they induce,” the investigators noted.

“Policy efforts designed to dismantle systemic racism are critically needed. Interventions that address SDI, including programming designed to support Black men through their experiences with racial discrimination and processing of childhood experiences of adversity, may help young Black men resist the psychological impacts of racism, expand their positive support networks, and decrease their risk of SDI,” they added.

The study authors reported no funding sources or relevant financial relationships.

A version of this article appeared on Medscape.com.

Every time a patient visits Jason Connelly, MD, they must fill out a depression screening, thanks to a 2017 rule which mandates such assessments.

Providing a screening and, if needed, a follow-up plan means a patient may gain access to medication or cognitive-behavioral therapy that will improve their lives. But Dr. Connelly, a family medicine physician at Novant Health West Rowan Family Medicine in Cleveland, North Carolina, said the screening measure — and others like it that insurers and quality groups use to assess clinician performance — does not allow for enough flexibility.

For instance, he must follow-up with patients every 4 months, regardless of the severity of their depression.

“A lot of times when these are written for the purpose of measures, they don’t take into consideration the reality of clinical medicine,” Dr. Connelly, who is also a clinical physician executive with Novant, said. “There certainly needs to be room for the ability to specify the level of depression such that if it is mild, well, maybe that follow-up is at 6 months or 12 months or at patient discretion.”

A recent report from the American College of Physicians (ACP) supported Dr. Connelly’s view. The body looked at eight quality measures in primary care for patients with major depressive disorder (MDD) and found only one — a risk assessment for suicide — to be clinically meaningful and based on evidence.

The ACP panel said nearly all of the performance measures “lacked current clinical evidence, did not consider patient preferences, were not tested appropriately, or were outside a physician’s control.”

The group called for improvements in such assessments “to accurately assess the quality of clinical care” for patients with major depression.

Necessary Evil or Burdensome Time Suck?

The Centers for Medicare & Medicaid Services scores clinicians and health systems on the percentage of their patients who receive a screening during a visit; if the screening is positive, clinicians must document a follow-up plan using special manual entry codes.

Physicians say the process of meeting government standards for invalid measures can create unnecessary visits and physician paperwork, shrink monetary bonuses, and may not portray an accurate portrait of what best practice looks like in primary care for mental health. But many also said the program overall brings value to patients and provides a picture of how well they are practicing but only when measures are clinically relevant.

Standards ACP Used for Validating Depression Measurement

A committee with ACP used a modified appropriateness method from RAND and UCLA.

They weighed if a metric was evidence-based, methodologically sound, and clinically meaningful.

They rated each measure using a 9-point scale, including appropriate care, feasibility or applicability, and measure specifications.

A total of 11 committee members voted anonymously if each metric was a valid way of measuring individual clinicians, at the practice/system level, and health plan.

“There’s been such a flood of performance measurements that we can get sidetracked, diverted, and spend resources and effort on measurements that don’t improve care,” said Nick Fitterman, MD, chair of the ACP’s Performance Measurement Committee.

Primary care clinicians can choose from more than 60 metrics for 2024. Many involve caring for patients with mental illness or screening for those who could be underdiagnosed. Programs that certify health systems as providing quality care use the measures, in addition to the Merit-Based Incentive Payment System. Health systems choose six measures of quality to tie to their reimbursement — along with assessments of costs and use of technology.

In turn, Medicare adjusts its reimbursement based on how well a clinician’s numbers turn out and if they improved over time.

“You don’t get the benefit of the upside if you don’t meet the measure, so your payment is neutral and that can be significant from a broader system lens,” Dr. Connelly said. “Then you start to have to make decisions on what services do we then have to limit because we no longer have the financial capability.”

The implications for health systems and patient care are the reason ACP and clinicians are calling for some measures to be amended. Dr. Fitterman said his organization plans to work with CMS.

Implementing Measurement

At Bassett Health in New York, the health system uses the depression and follow-up plan measure to qualify for certification from the Health Resources and Services Administration as a patient-centered medical home, which the company uses in part to market itself to patients.

Amy Grace, MD, an attending physician in internal and family medicine at Bassett Health in Little Falls, New York, said if a patient refuses to take a depression screening, she will not meet the measure for that visit. But providing a screening is not always clinically appropriate, and some patients do not need a follow-up plan.

“If someone has just had a death in the family, they might answer the questions in a way that would be consistent with depression, but they’re experiencing grief as opposed to clinical depression,” Dr. Grace said.

Suggestions From ACP for Improvement in MDD Metrics

• Create and implement criteria for patients who do not need a follow-up plan based on clinician judgment.
• Add methods for clinicians to measure and indicate severity of MDD.
• Enable use of a wider array of evidence-based tools and screenings to screen for MDD.
• Allow clinicians to document changes in treatment plan.

Bassett is building into the electronic health record a button that documents the screening was not conducted and that it was not appropriate to administer that day. Of course, building these in-house options entails utilizing resources that smaller systems or independent groups of clinicians may lack.

Eric Wei, MD, senior vice president and chief quality officer at NYC Health + Hospitals in New York City, said the ACP report underscores that many measures, even beyond depression, must be improved.

“With burnout and cognitive overload of our providers, on top of the medicine and just trying to come to the right diagnosis and providing the right treatment and the best care experience, you have to remember all these quality metrics and make sure you put all these things in certain places in the electronic health record,” Dr. Wei said.

Still, Dr. Wei said that the annual rate of depression screening across 400,000 patients in his system is 91%. He and his team spent 6 years working to improve uptake among clinicians, and now, they have moved on to increasing rates of administration of the suicide assessment.

Each clinician uses a dashboard to track their individual metric performance, according to Ted Long, MD, senior vice president for ambulatory care and population health at NYC Health + Hospitals. Dr. Long said he is proud of the improvements he and his colleagues have made in catching undiagnosed depression and in other disease states.

At his primary care practice in the Bronx, nearly 9 out of 10 patients with hypertension have their condition under control, he said. How does he know? Measurement tracking.

“Knowing that when a new patient is in front of me with high blood pressure, that there’s a 9 out of 10 chance that after seeing me because of my clinic, not just because of me, I’m going to be able to keep them healthy by controlling their blood pressure, that’s very meaningful to me,” Dr. Long said. “I think that’s the other side: It enables me as a doctor to know that I’m delivering the highest quality of care to my patients.”

Takeaways for Depression Screening and Follow-Up in Clinical Settings

Just because a patient scores positive for the depression screener, a clinician should dig deeper before making a diagnosis.

Patients have the right to refuse a screener and their wishes should be respected.

Providing a screener may not be appropriate at every visit, such as for a patient with a sprained ankle or a potential respiratory infection where time is limited.

Clinicians can clarify within the measure that the patient did not have mental capacity on that visit to fill out the screener.

A version of this article appeared on Medscape.com.

Every time a patient visits Jason Connelly, MD, they must fill out a depression screening, thanks to a 2017 rule which mandates such assessments.

Providing a screening and, if needed, a follow-up plan means a patient may gain access to medication or cognitive-behavioral therapy that will improve their lives. But Dr. Connelly, a family medicine physician at Novant Health West Rowan Family Medicine in Cleveland, North Carolina, said the screening measure — and others like it that insurers and quality groups use to assess clinician performance — does not allow for enough flexibility.

For instance, he must follow-up with patients every 4 months, regardless of the severity of their depression.

“A lot of times when these are written for the purpose of measures, they don’t take into consideration the reality of clinical medicine,” Dr. Connelly, who is also a clinical physician executive with Novant, said. “There certainly needs to be room for the ability to specify the level of depression such that if it is mild, well, maybe that follow-up is at 6 months or 12 months or at patient discretion.”

A recent report from the American College of Physicians (ACP) supported Dr. Connelly’s view. The body looked at eight quality measures in primary care for patients with major depressive disorder (MDD) and found only one — a risk assessment for suicide — to be clinically meaningful and based on evidence.

The ACP panel said nearly all of the performance measures “lacked current clinical evidence, did not consider patient preferences, were not tested appropriately, or were outside a physician’s control.”

The group called for improvements in such assessments “to accurately assess the quality of clinical care” for patients with major depression.

Necessary Evil or Burdensome Time Suck?

The Centers for Medicare & Medicaid Services scores clinicians and health systems on the percentage of their patients who receive a screening during a visit; if the screening is positive, clinicians must document a follow-up plan using special manual entry codes.

Physicians say the process of meeting government standards for invalid measures can create unnecessary visits and physician paperwork, shrink monetary bonuses, and may not portray an accurate portrait of what best practice looks like in primary care for mental health. But many also said the program overall brings value to patients and provides a picture of how well they are practicing but only when measures are clinically relevant.

Standards ACP Used for Validating Depression Measurement

A committee with ACP used a modified appropriateness method from RAND and UCLA.

They weighed if a metric was evidence-based, methodologically sound, and clinically meaningful.

They rated each measure using a 9-point scale, including appropriate care, feasibility or applicability, and measure specifications.

A total of 11 committee members voted anonymously if each metric was a valid way of measuring individual clinicians, at the practice/system level, and health plan.

“There’s been such a flood of performance measurements that we can get sidetracked, diverted, and spend resources and effort on measurements that don’t improve care,” said Nick Fitterman, MD, chair of the ACP’s Performance Measurement Committee.

Primary care clinicians can choose from more than 60 metrics for 2024. Many involve caring for patients with mental illness or screening for those who could be underdiagnosed. Programs that certify health systems as providing quality care use the measures, in addition to the Merit-Based Incentive Payment System. Health systems choose six measures of quality to tie to their reimbursement — along with assessments of costs and use of technology.

In turn, Medicare adjusts its reimbursement based on how well a clinician’s numbers turn out and if they improved over time.

“You don’t get the benefit of the upside if you don’t meet the measure, so your payment is neutral and that can be significant from a broader system lens,” Dr. Connelly said. “Then you start to have to make decisions on what services do we then have to limit because we no longer have the financial capability.”

The implications for health systems and patient care are the reason ACP and clinicians are calling for some measures to be amended. Dr. Fitterman said his organization plans to work with CMS.

Implementing Measurement

At Bassett Health in New York, the health system uses the depression and follow-up plan measure to qualify for certification from the Health Resources and Services Administration as a patient-centered medical home, which the company uses in part to market itself to patients.

Amy Grace, MD, an attending physician in internal and family medicine at Bassett Health in Little Falls, New York, said if a patient refuses to take a depression screening, she will not meet the measure for that visit. But providing a screening is not always clinically appropriate, and some patients do not need a follow-up plan.

“If someone has just had a death in the family, they might answer the questions in a way that would be consistent with depression, but they’re experiencing grief as opposed to clinical depression,” Dr. Grace said.

Suggestions From ACP for Improvement in MDD Metrics

• Create and implement criteria for patients who do not need a follow-up plan based on clinician judgment.
• Add methods for clinicians to measure and indicate severity of MDD.
• Enable use of a wider array of evidence-based tools and screenings to screen for MDD.
• Allow clinicians to document changes in treatment plan.

Bassett is building into the electronic health record a button that documents the screening was not conducted and that it was not appropriate to administer that day. Of course, building these in-house options entails utilizing resources that smaller systems or independent groups of clinicians may lack.

Eric Wei, MD, senior vice president and chief quality officer at NYC Health + Hospitals in New York City, said the ACP report underscores that many measures, even beyond depression, must be improved.

“With burnout and cognitive overload of our providers, on top of the medicine and just trying to come to the right diagnosis and providing the right treatment and the best care experience, you have to remember all these quality metrics and make sure you put all these things in certain places in the electronic health record,” Dr. Wei said.

Still, Dr. Wei said that the annual rate of depression screening across 400,000 patients in his system is 91%. He and his team spent 6 years working to improve uptake among clinicians, and now, they have moved on to increasing rates of administration of the suicide assessment.

Each clinician uses a dashboard to track their individual metric performance, according to Ted Long, MD, senior vice president for ambulatory care and population health at NYC Health + Hospitals. Dr. Long said he is proud of the improvements he and his colleagues have made in catching undiagnosed depression and in other disease states.

At his primary care practice in the Bronx, nearly 9 out of 10 patients with hypertension have their condition under control, he said. How does he know? Measurement tracking.

“Knowing that when a new patient is in front of me with high blood pressure, that there’s a 9 out of 10 chance that after seeing me because of my clinic, not just because of me, I’m going to be able to keep them healthy by controlling their blood pressure, that’s very meaningful to me,” Dr. Long said. “I think that’s the other side: It enables me as a doctor to know that I’m delivering the highest quality of care to my patients.”

Takeaways for Depression Screening and Follow-Up in Clinical Settings

Just because a patient scores positive for the depression screener, a clinician should dig deeper before making a diagnosis.

Patients have the right to refuse a screener and their wishes should be respected.

Providing a screener may not be appropriate at every visit, such as for a patient with a sprained ankle or a potential respiratory infection where time is limited.

Clinicians can clarify within the measure that the patient did not have mental capacity on that visit to fill out the screener.

A version of this article appeared on Medscape.com.

Every time a patient visits Jason Connelly, MD, they must fill out a depression screening, thanks to a 2017 rule which mandates such assessments.

Providing a screening and, if needed, a follow-up plan means a patient may gain access to medication or cognitive-behavioral therapy that will improve their lives. But Dr. Connelly, a family medicine physician at Novant Health West Rowan Family Medicine in Cleveland, North Carolina, said the screening measure — and others like it that insurers and quality groups use to assess clinician performance — does not allow for enough flexibility.

For instance, he must follow-up with patients every 4 months, regardless of the severity of their depression.

“A lot of times when these are written for the purpose of measures, they don’t take into consideration the reality of clinical medicine,” Dr. Connelly, who is also a clinical physician executive with Novant, said. “There certainly needs to be room for the ability to specify the level of depression such that if it is mild, well, maybe that follow-up is at 6 months or 12 months or at patient discretion.”

A recent report from the American College of Physicians (ACP) supported Dr. Connelly’s view. The body looked at eight quality measures in primary care for patients with major depressive disorder (MDD) and found only one — a risk assessment for suicide — to be clinically meaningful and based on evidence.

The ACP panel said nearly all of the performance measures “lacked current clinical evidence, did not consider patient preferences, were not tested appropriately, or were outside a physician’s control.”

The group called for improvements in such assessments “to accurately assess the quality of clinical care” for patients with major depression.

Necessary Evil or Burdensome Time Suck?

The Centers for Medicare & Medicaid Services scores clinicians and health systems on the percentage of their patients who receive a screening during a visit; if the screening is positive, clinicians must document a follow-up plan using special manual entry codes.

Physicians say the process of meeting government standards for invalid measures can create unnecessary visits and physician paperwork, shrink monetary bonuses, and may not portray an accurate portrait of what best practice looks like in primary care for mental health. But many also said the program overall brings value to patients and provides a picture of how well they are practicing but only when measures are clinically relevant.

Standards ACP Used for Validating Depression Measurement

A committee with ACP used a modified appropriateness method from RAND and UCLA.

They weighed if a metric was evidence-based, methodologically sound, and clinically meaningful.

They rated each measure using a 9-point scale, including appropriate care, feasibility or applicability, and measure specifications.

A total of 11 committee members voted anonymously if each metric was a valid way of measuring individual clinicians, at the practice/system level, and health plan.

“There’s been such a flood of performance measurements that we can get sidetracked, diverted, and spend resources and effort on measurements that don’t improve care,” said Nick Fitterman, MD, chair of the ACP’s Performance Measurement Committee.

Primary care clinicians can choose from more than 60 metrics for 2024. Many involve caring for patients with mental illness or screening for those who could be underdiagnosed. Programs that certify health systems as providing quality care use the measures, in addition to the Merit-Based Incentive Payment System. Health systems choose six measures of quality to tie to their reimbursement — along with assessments of costs and use of technology.

In turn, Medicare adjusts its reimbursement based on how well a clinician’s numbers turn out and if they improved over time.

“You don’t get the benefit of the upside if you don’t meet the measure, so your payment is neutral and that can be significant from a broader system lens,” Dr. Connelly said. “Then you start to have to make decisions on what services do we then have to limit because we no longer have the financial capability.”

The implications for health systems and patient care are the reason ACP and clinicians are calling for some measures to be amended. Dr. Fitterman said his organization plans to work with CMS.

Implementing Measurement

At Bassett Health in New York, the health system uses the depression and follow-up plan measure to qualify for certification from the Health Resources and Services Administration as a patient-centered medical home, which the company uses in part to market itself to patients.

Amy Grace, MD, an attending physician in internal and family medicine at Bassett Health in Little Falls, New York, said if a patient refuses to take a depression screening, she will not meet the measure for that visit. But providing a screening is not always clinically appropriate, and some patients do not need a follow-up plan.

“If someone has just had a death in the family, they might answer the questions in a way that would be consistent with depression, but they’re experiencing grief as opposed to clinical depression,” Dr. Grace said.

Suggestions From ACP for Improvement in MDD Metrics

• Create and implement criteria for patients who do not need a follow-up plan based on clinician judgment.
• Add methods for clinicians to measure and indicate severity of MDD.
• Enable use of a wider array of evidence-based tools and screenings to screen for MDD.
• Allow clinicians to document changes in treatment plan.

Bassett is building into the electronic health record a button that documents the screening was not conducted and that it was not appropriate to administer that day. Of course, building these in-house options entails utilizing resources that smaller systems or independent groups of clinicians may lack.

Eric Wei, MD, senior vice president and chief quality officer at NYC Health + Hospitals in New York City, said the ACP report underscores that many measures, even beyond depression, must be improved.

“With burnout and cognitive overload of our providers, on top of the medicine and just trying to come to the right diagnosis and providing the right treatment and the best care experience, you have to remember all these quality metrics and make sure you put all these things in certain places in the electronic health record,” Dr. Wei said.

Still, Dr. Wei said that the annual rate of depression screening across 400,000 patients in his system is 91%. He and his team spent 6 years working to improve uptake among clinicians, and now, they have moved on to increasing rates of administration of the suicide assessment.

Each clinician uses a dashboard to track their individual metric performance, according to Ted Long, MD, senior vice president for ambulatory care and population health at NYC Health + Hospitals. Dr. Long said he is proud of the improvements he and his colleagues have made in catching undiagnosed depression and in other disease states.

At his primary care practice in the Bronx, nearly 9 out of 10 patients with hypertension have their condition under control, he said. How does he know? Measurement tracking.

“Knowing that when a new patient is in front of me with high blood pressure, that there’s a 9 out of 10 chance that after seeing me because of my clinic, not just because of me, I’m going to be able to keep them healthy by controlling their blood pressure, that’s very meaningful to me,” Dr. Long said. “I think that’s the other side: It enables me as a doctor to know that I’m delivering the highest quality of care to my patients.”

Takeaways for Depression Screening and Follow-Up in Clinical Settings

Just because a patient scores positive for the depression screener, a clinician should dig deeper before making a diagnosis.

Patients have the right to refuse a screener and their wishes should be respected.

Providing a screener may not be appropriate at every visit, such as for a patient with a sprained ankle or a potential respiratory infection where time is limited.

Clinicians can clarify within the measure that the patient did not have mental capacity on that visit to fill out the screener.

A version of this article appeared on Medscape.com.

TOPLINE:

Insulin resistance and obesity in adolescents may lead to increased abdominal fibrogenesis, impairing the capacity of the abdominal subcutaneous adipose tissue (SAT) to store lipids, which may cause fat accumulation in the visceral adipose tissue (VAT) depot and in other organs such as the liver.

METHODOLOGY:

• Abdominal fibrogenesis, but not adipose tissue expandability, is known to increase in adults with obesity and reduce insulin sensitivity; however, little is known about fibrogenesis in adolescents with obesity.
• In this study, researchers investigated if lipid dynamics, fibrogenesis, and abdominal and gluteal adipocyte turnover show dysregulation to a greater extent in insulin-resistant adolescents with obesity than in insulin-sensitive adolescents with obesity.
• They recruited 14 individuals between 12 and 20 years with a body mass index over 30 from the Yale  Clinic, of whom seven participants were classified as insulin resistant.
• Deuterated water methodologies were used to study the indices of adipocyte turnover, lipid dynamics, and fibrogenesis in abdominal and gluteal fat deposits.
• A 3-hour oral glucose tolerance test and multisection MRI scan of the abdominal region were used to assess the indices of glucose metabolism, abdominal fat distribution patterns, and liver fat content.

TAKEAWAY:

• The abdominal and gluteal SAT turnover rate of lipid components (triglyceride production and breakdown as well as de novo lipogenesis contribution) was similar in insulin-resistant and insulin-sensitive adolescents with obesity.
• The insoluble collagen (type I, subunit alpha2) level was higher in the abdominal adipose tissue of insulin-resistant adolescents than in insulin-sensitive adolescents (difference in fractional synthesis rate, 0.611; P < .001), indicating increased abdominal fibrogenesis.
• Abdominal insoluble collagen I alpha2 was associated with higher fasting plasma insulin levels (correlation [r], 0.579; P = .015), a higher visceral to total adipose tissue ratio (r, 0.643; P = .007), and a lower whole-body insulin sensitivity index (r, -0.540; P = .023).
• There was no evidence of increased collagen production in the gluteal adipose tissue, and as a result, fibrogenesis was observed.

IN PRACTICE:

“The increased formation of insoluble collagen observed in insulin-resistant compared with insulin-sensitive individuals contributes to lipid spillover from SAT to VAT and, in turn, serves as a critically important mechanism involved in the complex sequelae of obesity-related metabolic and liver disease pathology,” the authors wrote.

SOURCE:

This study, led by Aaron L. Slusher, Department of Pediatrics, Yale School of Medicine, New Haven, Connecticut, was published online in Obesity.

LIMITATIONS:

The researchers did not measure hepatic collagen synthesis rates. The analysis was performed on a small study population. The authors were also unable to assess potential sex differences.

DISCLOSURES:

The study was funded by the Foundation for the National Institutes of Health and Clara Guthrie Patterson Trust Mentored Research Award. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Insulin resistance and obesity in adolescents may lead to increased abdominal fibrogenesis, impairing the capacity of the abdominal subcutaneous adipose tissue (SAT) to store lipids, which may cause fat accumulation in the visceral adipose tissue (VAT) depot and in other organs such as the liver.

METHODOLOGY:

• Abdominal fibrogenesis, but not adipose tissue expandability, is known to increase in adults with obesity and reduce insulin sensitivity; however, little is known about fibrogenesis in adolescents with obesity.
• In this study, researchers investigated if lipid dynamics, fibrogenesis, and abdominal and gluteal adipocyte turnover show dysregulation to a greater extent in insulin-resistant adolescents with obesity than in insulin-sensitive adolescents with obesity.
• They recruited 14 individuals between 12 and 20 years with a body mass index over 30 from the Yale  Clinic, of whom seven participants were classified as insulin resistant.
• Deuterated water methodologies were used to study the indices of adipocyte turnover, lipid dynamics, and fibrogenesis in abdominal and gluteal fat deposits.
• A 3-hour oral glucose tolerance test and multisection MRI scan of the abdominal region were used to assess the indices of glucose metabolism, abdominal fat distribution patterns, and liver fat content.

TAKEAWAY:

• The abdominal and gluteal SAT turnover rate of lipid components (triglyceride production and breakdown as well as de novo lipogenesis contribution) was similar in insulin-resistant and insulin-sensitive adolescents with obesity.
• The insoluble collagen (type I, subunit alpha2) level was higher in the abdominal adipose tissue of insulin-resistant adolescents than in insulin-sensitive adolescents (difference in fractional synthesis rate, 0.611; P < .001), indicating increased abdominal fibrogenesis.
• Abdominal insoluble collagen I alpha2 was associated with higher fasting plasma insulin levels (correlation [r], 0.579; P = .015), a higher visceral to total adipose tissue ratio (r, 0.643; P = .007), and a lower whole-body insulin sensitivity index (r, -0.540; P = .023).
• There was no evidence of increased collagen production in the gluteal adipose tissue, and as a result, fibrogenesis was observed.

IN PRACTICE:

“The increased formation of insoluble collagen observed in insulin-resistant compared with insulin-sensitive individuals contributes to lipid spillover from SAT to VAT and, in turn, serves as a critically important mechanism involved in the complex sequelae of obesity-related metabolic and liver disease pathology,” the authors wrote.

SOURCE:

This study, led by Aaron L. Slusher, Department of Pediatrics, Yale School of Medicine, New Haven, Connecticut, was published online in Obesity.

LIMITATIONS:

The researchers did not measure hepatic collagen synthesis rates. The analysis was performed on a small study population. The authors were also unable to assess potential sex differences.

DISCLOSURES:

The study was funded by the Foundation for the National Institutes of Health and Clara Guthrie Patterson Trust Mentored Research Award. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Insulin resistance and obesity in adolescents may lead to increased abdominal fibrogenesis, impairing the capacity of the abdominal subcutaneous adipose tissue (SAT) to store lipids, which may cause fat accumulation in the visceral adipose tissue (VAT) depot and in other organs such as the liver.

METHODOLOGY:

• Abdominal fibrogenesis, but not adipose tissue expandability, is known to increase in adults with obesity and reduce insulin sensitivity; however, little is known about fibrogenesis in adolescents with obesity.
• In this study, researchers investigated if lipid dynamics, fibrogenesis, and abdominal and gluteal adipocyte turnover show dysregulation to a greater extent in insulin-resistant adolescents with obesity than in insulin-sensitive adolescents with obesity.
• They recruited 14 individuals between 12 and 20 years with a body mass index over 30 from the Yale  Clinic, of whom seven participants were classified as insulin resistant.
• Deuterated water methodologies were used to study the indices of adipocyte turnover, lipid dynamics, and fibrogenesis in abdominal and gluteal fat deposits.
• A 3-hour oral glucose tolerance test and multisection MRI scan of the abdominal region were used to assess the indices of glucose metabolism, abdominal fat distribution patterns, and liver fat content.

TAKEAWAY:

• The abdominal and gluteal SAT turnover rate of lipid components (triglyceride production and breakdown as well as de novo lipogenesis contribution) was similar in insulin-resistant and insulin-sensitive adolescents with obesity.
• The insoluble collagen (type I, subunit alpha2) level was higher in the abdominal adipose tissue of insulin-resistant adolescents than in insulin-sensitive adolescents (difference in fractional synthesis rate, 0.611; P < .001), indicating increased abdominal fibrogenesis.
• Abdominal insoluble collagen I alpha2 was associated with higher fasting plasma insulin levels (correlation [r], 0.579; P = .015), a higher visceral to total adipose tissue ratio (r, 0.643; P = .007), and a lower whole-body insulin sensitivity index (r, -0.540; P = .023).
• There was no evidence of increased collagen production in the gluteal adipose tissue, and as a result, fibrogenesis was observed.

IN PRACTICE:

“The increased formation of insoluble collagen observed in insulin-resistant compared with insulin-sensitive individuals contributes to lipid spillover from SAT to VAT and, in turn, serves as a critically important mechanism involved in the complex sequelae of obesity-related metabolic and liver disease pathology,” the authors wrote.

SOURCE:

This study, led by Aaron L. Slusher, Department of Pediatrics, Yale School of Medicine, New Haven, Connecticut, was published online in Obesity.

LIMITATIONS:

The researchers did not measure hepatic collagen synthesis rates. The analysis was performed on a small study population. The authors were also unable to assess potential sex differences.

DISCLOSURES:

The study was funded by the Foundation for the National Institutes of Health and Clara Guthrie Patterson Trust Mentored Research Award. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

In 1974, Tommy John of the Los Angeles Dodgers was 31 and a 12-year veteran of Major League Baseball when he became the unwitting vanguard of a revolution in baseball and orthopedics. Fifty years later, Mr. John might not be a candidate for the latest advances to a procedure that bears his name.

The southpaw pitcher had faced the abrupt end of his career when, after one fateful delivery, he found himself unable to throw to home. So he took a gamble on the surgical equivalent of a Hail Mary: the reconstruction of a torn ligament in his pitching elbow.

The experiment was a wild success. Mr. John pitched— and better than he had before — for another 14 seasons, retiring in 1989 at the age of 46. How much better? After the surgery, he tallied three 20-win seasons compared with none before the operation, and he finished among the top five vote-getters for the annual Cy Young Award three times. He was named an All-Star once before the surgery and three times after.

The triumph notwithstanding, Tommy John now cautions against Tommy John surgery. What’s given him and clinicians pause is a trend in recent years of ever-younger athletes who undergo the procedure.

Along with the surgical improvements in repairing a torn ulnar collateral ligament (UCL) is a demographic shift toward school-aged athletes who get it. By 2014, one study concluded that 67.4% of UCL reconstruction surgeries were performed on athletes between 16 and 20 years of age. Some patients are still in Little League when they undergo the procedure.

Experts say these athletes have weakened their UCLs through overuse. They disagree on whether to call it an “epidemic,” but if it is, “the vaccine is awareness” against throwing too hard and too often, said Eric Makhni, MD, an orthopedic surgeon at Henry Ford Health in Detroit.
 

From Career-Ending to Routine

Mr. John’s entry into baseball and orthopedic lore was initially slow, but the trickle turned into a tide. After Frank Jobe, MD, swapped a healthy tendon from John’s right wrist for his worn and torn left UCL on September 25, 1974, he didn’t perform his second surgery for another 1194 days. By the time “Tommy John surgery” became a recognized phrase, Mr. John was still active but only 14 professional baseball players had undergone the operation.

Prior to the start of spring training this year, an oft-cited database listed 366 pro players who’d undergone the operation. 

“Before Tommy John, that was a career-ending injury,” said Grant E. Garrigues, MD, an orthopedic surgeon at Midwest Orthopaedics at RUSH in Chicago, who called Mr. John “a pure revolutionary.”

Tommy John surgery is “the only one that I can think of that is named after the patient rather than the doctor who first did it,” said Patrick McCulloch, MD, an orthopedic surgeon in Houston and a team physician for the Astros.

Dr. McCulloch, who performs about 25 UCL repairs a year, said that by recent estimates, one-third of pro pitchers had had some sort of surgical repair. He hesitated to call the increasing number of operations an epidemic but acknowledged that the ingredients exist for more elbow trauma among baseball players.

“More people are playing more often, and people are bigger and stronger and throwing harder,” he said.

Either way, Dr. McCulloch said, “the procedure is a victim of its own success” because it is “just done phenomenally well.”

The surgery is now commonplace — perhaps too commonplace, said David W. Altchek, MD, attending surgeon and co-chief emeritus at Hospital for Special Surgery in New York City.

Dr. Altchek played a key role in the popularity of the operation. Twenty-two years after Mr. John’s surgery, he helped develop a variation of the procedure called the docking technique. 

Whereas Dr. Jobe sutured Mr. John’s replacement graft to itself, “we developed a different way of tying it over a bone bridge, which was more secure and more easy to tension,” Dr. Altchek explained.

The advance meant less drilling into bone and enabled surgeons to avoid moving a problem-free ulnar nerve or removing the flexor-pronator muscle that protects the elbow from stress. “The trauma of the surgery is significantly less,” he said. “We just made it a lot easier very quickly,” cutting the surgery time from 2 hours to 30-40 minutes.

Maybe the surgery became too easy, said Dr. Altchek, who estimates he has done 2000 of them over the past 30 years. “I don’t want to condemn my colleagues, but there are a lot of people doing the surgery,” he said. “And not a lot of people are doing a lot of them, and they don’t know the nuances of doing the surgery.”

The older procedures are known as the “full Tommy John”; each has a 12- to 18-month healing process, with a success rate of 80%-85%. Pitchers typically sit out a season while recovering.

Brandon Erickson, MD, an orthopedic surgeon at Rothman Orthopaedic Institute in New York City, said that in younger patients he has recently turned more often to the suture of the future: an internal brace that provides a repair rather than reconstruction.

The procedure, pioneered by Felix H. Savoie III, MD, the Ray J. Haddad Professor of Orthopaedics at Tulane University School of Medicine in New Orleans, and Jeffrey R. Dugas, MD, of Andrews Sports Medicine & Orthopaedic Center in Birmingham, Alabama, uses collagen-coated tape that looks like a shoelace and provides a scaffold that Dr. McCulloch said “is inductive to healing and growth of ligament tissue.”

The brace is intended for an “overhead” athlete (mostly baseball players but also javelin throwers and gymnasts) whose UCL is torn on only one side but is otherwise in good shape. In a pitcher the same age as Mr. John was when Dr. Jobe performed the first procedure, “that ligament may not be of very good quality,” Dr. McCulloch said. “It may have thickened. It may have calcifications.” But for a high-school junior with aspirations to pitch in college or beyond without “way too many miles on the elbow,” the approach is a good fit. The healing process is as little as 6 months.

“The ones who have a good ligament are very likely to do well,” said Dr. Erickson, an assistant team doctor for the Philadelphia Phillies.

“If the patient’s ligament is generally ‘good’ with only a tear, the InternalBrace procedure may be used to repair the native ligament. On the other end of the spectrum, if the patient’s ligament is torn and degenerative the surgeon may opt to do a UCL reconstruction using an auto or allograft — ie, Tommy John surgery,” Allen Holowecky, senior product manager of Arthrex of Naples, Florida, the maker of the InternalBrace, told this news organization. “Before UCL repair, Tommy John surgery was the only real treatment option. We tend to see repairs done on younger patients since their ligament hasn’t seen years of use-damage.”
 

Calls for Caution

Tommy John III wanted to play baseball like his dad until near-fatal complications from shoulder surgery altered his path. He was drawn to chiropractic and consults on injury prevention. “All surgeries and all medical interventions are cut first, ask questions later,” he said. “I was born with that.”

He saw his dad’s slow, heroic comeback from the surgery and described him as the perfect candidate for Dr. Jobe’s experiment. Tommy John spent his recovery time squeezing Silly Putty and throwing tennis balls. “He was willing to do anything necessary. He wanted to throw. That was his brush.” When the son was recovering from his own injury, “he said, ‘Learn the knuckleball.’ I said, ‘I don’t want to. I’ve reached my point.’ ”

He said he tells young patients with UCL injuries to rest. But instead “we have year-round sports with the promise that the more you play, the better,” he said. “They’re over-activitied.”

According to the American Academy of Orthopaedic Surgeons, 6.4 million children and adolescents in the United States played organized baseball in 2022, down from 11.5 million in 2014. Nearly half of pitchers played in a league with no maximum pitch counts, and 43.5% pitched on consecutive days, the group said.

How many UCL repair or reconstruction surgeries are performed on youth athletes each year is unclear. A 2019 study, however, found that although baseball injuries decreased between 2006 and 2016, the elbow was “the only location of injury that saw an increase.”

Dr. Garrigues said some parents of throwing athletes have asked about prophylactic Tommy John surgery for their children. He said it shouldn’t apply to pitchers.

“People have taken it a little too far,” he said. Dr. Garrigues and others argue against children throwing weighted balls when coming back from surgery. Instead, “we’re shutting them down,” he said.

Throwing any pitch is an act of violence on the body, Dr. Garrigues said, with the elbow taking the final brunt of the force. “These pitchers are functioning at the absolute limits of what the human body can take,” he said. “There’s only so many bullets in a gun,” which is why pitchers often feel the twinge of a torn UCL on a routine pitch.

Dr. Makhni suggested cross-training for pitchers in the off-season instead of playing baseball year-round. “If you play soccer, your footwork is going to be better,” he said.

“Kids shouldn’t be doing this all year round,” said Rebecca Carl, MD, associate professor of pediatrics at Northwestern University Feinberg School of Medicine in Chicago. “We are recommending that kids take 2 or 3 months off.” In the off-season, she urges them to strengthen their backs and cores. 

Such advice can “feel like a bombshell,” said Dr. Carl, who chairs the Council on Sports Medicine and Fitness for the American Academy of Pediatrics. ‘Some started at a very young age. They go to camps. If I say to a teenager, ‘If you do this, I can keep you from getting injured,’ they think, ‘I won’t be injured.’” Most parents, however, understand the risk of “doing too much, too soon.”

Justin Orenduff, a former pitching prospect until his arm blew out, has made a career teaching head-to-toe pitching mechanics. He founded DVS Baseball, which uses software to teach pitchers how to properly use every muscle, starting with the orientation of the back foot. He, too, argues against pitching year-round. “Everyone on that travel team expects to get their fair share of playing time,” he said. “It just never stops.”

Organized baseball is paying attention. It has come up with the Pitch Smart program that gives maximum pitch counts for young players, but experts said children often get around that by belonging to several leagues.

Dr. Altchek said some surgeons have added platelet-rich plasma, stem cells, and bone marrow during surgery to quicken the slow healing time from UCL replacement. But he said, “it has to heal. Can you speed up biology?”

Dr. McCulloch said that, all the advances in Tommy John surgery aside, “the next frontier is really trying to crack the code on prevention.”

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

In 1974, Tommy John of the Los Angeles Dodgers was 31 and a 12-year veteran of Major League Baseball when he became the unwitting vanguard of a revolution in baseball and orthopedics. Fifty years later, Mr. John might not be a candidate for the latest advances to a procedure that bears his name.

The southpaw pitcher had faced the abrupt end of his career when, after one fateful delivery, he found himself unable to throw to home. So he took a gamble on the surgical equivalent of a Hail Mary: the reconstruction of a torn ligament in his pitching elbow.

The experiment was a wild success. Mr. John pitched— and better than he had before — for another 14 seasons, retiring in 1989 at the age of 46. How much better? After the surgery, he tallied three 20-win seasons compared with none before the operation, and he finished among the top five vote-getters for the annual Cy Young Award three times. He was named an All-Star once before the surgery and three times after.

The triumph notwithstanding, Tommy John now cautions against Tommy John surgery. What’s given him and clinicians pause is a trend in recent years of ever-younger athletes who undergo the procedure.

Along with the surgical improvements in repairing a torn ulnar collateral ligament (UCL) is a demographic shift toward school-aged athletes who get it. By 2014, one study concluded that 67.4% of UCL reconstruction surgeries were performed on athletes between 16 and 20 years of age. Some patients are still in Little League when they undergo the procedure.

Experts say these athletes have weakened their UCLs through overuse. They disagree on whether to call it an “epidemic,” but if it is, “the vaccine is awareness” against throwing too hard and too often, said Eric Makhni, MD, an orthopedic surgeon at Henry Ford Health in Detroit.
 

From Career-Ending to Routine

Mr. John’s entry into baseball and orthopedic lore was initially slow, but the trickle turned into a tide. After Frank Jobe, MD, swapped a healthy tendon from John’s right wrist for his worn and torn left UCL on September 25, 1974, he didn’t perform his second surgery for another 1194 days. By the time “Tommy John surgery” became a recognized phrase, Mr. John was still active but only 14 professional baseball players had undergone the operation.

Prior to the start of spring training this year, an oft-cited database listed 366 pro players who’d undergone the operation. 

“Before Tommy John, that was a career-ending injury,” said Grant E. Garrigues, MD, an orthopedic surgeon at Midwest Orthopaedics at RUSH in Chicago, who called Mr. John “a pure revolutionary.”

Tommy John surgery is “the only one that I can think of that is named after the patient rather than the doctor who first did it,” said Patrick McCulloch, MD, an orthopedic surgeon in Houston and a team physician for the Astros.

Dr. McCulloch, who performs about 25 UCL repairs a year, said that by recent estimates, one-third of pro pitchers had had some sort of surgical repair. He hesitated to call the increasing number of operations an epidemic but acknowledged that the ingredients exist for more elbow trauma among baseball players.

“More people are playing more often, and people are bigger and stronger and throwing harder,” he said.

Either way, Dr. McCulloch said, “the procedure is a victim of its own success” because it is “just done phenomenally well.”

The surgery is now commonplace — perhaps too commonplace, said David W. Altchek, MD, attending surgeon and co-chief emeritus at Hospital for Special Surgery in New York City.

Dr. Altchek played a key role in the popularity of the operation. Twenty-two years after Mr. John’s surgery, he helped develop a variation of the procedure called the docking technique. 

Whereas Dr. Jobe sutured Mr. John’s replacement graft to itself, “we developed a different way of tying it over a bone bridge, which was more secure and more easy to tension,” Dr. Altchek explained.

The advance meant less drilling into bone and enabled surgeons to avoid moving a problem-free ulnar nerve or removing the flexor-pronator muscle that protects the elbow from stress. “The trauma of the surgery is significantly less,” he said. “We just made it a lot easier very quickly,” cutting the surgery time from 2 hours to 30-40 minutes.

Maybe the surgery became too easy, said Dr. Altchek, who estimates he has done 2000 of them over the past 30 years. “I don’t want to condemn my colleagues, but there are a lot of people doing the surgery,” he said. “And not a lot of people are doing a lot of them, and they don’t know the nuances of doing the surgery.”

The older procedures are known as the “full Tommy John”; each has a 12- to 18-month healing process, with a success rate of 80%-85%. Pitchers typically sit out a season while recovering.

Brandon Erickson, MD, an orthopedic surgeon at Rothman Orthopaedic Institute in New York City, said that in younger patients he has recently turned more often to the suture of the future: an internal brace that provides a repair rather than reconstruction.

The procedure, pioneered by Felix H. Savoie III, MD, the Ray J. Haddad Professor of Orthopaedics at Tulane University School of Medicine in New Orleans, and Jeffrey R. Dugas, MD, of Andrews Sports Medicine & Orthopaedic Center in Birmingham, Alabama, uses collagen-coated tape that looks like a shoelace and provides a scaffold that Dr. McCulloch said “is inductive to healing and growth of ligament tissue.”

The brace is intended for an “overhead” athlete (mostly baseball players but also javelin throwers and gymnasts) whose UCL is torn on only one side but is otherwise in good shape. In a pitcher the same age as Mr. John was when Dr. Jobe performed the first procedure, “that ligament may not be of very good quality,” Dr. McCulloch said. “It may have thickened. It may have calcifications.” But for a high-school junior with aspirations to pitch in college or beyond without “way too many miles on the elbow,” the approach is a good fit. The healing process is as little as 6 months.

“The ones who have a good ligament are very likely to do well,” said Dr. Erickson, an assistant team doctor for the Philadelphia Phillies.

“If the patient’s ligament is generally ‘good’ with only a tear, the InternalBrace procedure may be used to repair the native ligament. On the other end of the spectrum, if the patient’s ligament is torn and degenerative the surgeon may opt to do a UCL reconstruction using an auto or allograft — ie, Tommy John surgery,” Allen Holowecky, senior product manager of Arthrex of Naples, Florida, the maker of the InternalBrace, told this news organization. “Before UCL repair, Tommy John surgery was the only real treatment option. We tend to see repairs done on younger patients since their ligament hasn’t seen years of use-damage.”
 

Calls for Caution

Tommy John III wanted to play baseball like his dad until near-fatal complications from shoulder surgery altered his path. He was drawn to chiropractic and consults on injury prevention. “All surgeries and all medical interventions are cut first, ask questions later,” he said. “I was born with that.”

He saw his dad’s slow, heroic comeback from the surgery and described him as the perfect candidate for Dr. Jobe’s experiment. Tommy John spent his recovery time squeezing Silly Putty and throwing tennis balls. “He was willing to do anything necessary. He wanted to throw. That was his brush.” When the son was recovering from his own injury, “he said, ‘Learn the knuckleball.’ I said, ‘I don’t want to. I’ve reached my point.’ ”

He said he tells young patients with UCL injuries to rest. But instead “we have year-round sports with the promise that the more you play, the better,” he said. “They’re over-activitied.”

According to the American Academy of Orthopaedic Surgeons, 6.4 million children and adolescents in the United States played organized baseball in 2022, down from 11.5 million in 2014. Nearly half of pitchers played in a league with no maximum pitch counts, and 43.5% pitched on consecutive days, the group said.

How many UCL repair or reconstruction surgeries are performed on youth athletes each year is unclear. A 2019 study, however, found that although baseball injuries decreased between 2006 and 2016, the elbow was “the only location of injury that saw an increase.”

Dr. Garrigues said some parents of throwing athletes have asked about prophylactic Tommy John surgery for their children. He said it shouldn’t apply to pitchers.

“People have taken it a little too far,” he said. Dr. Garrigues and others argue against children throwing weighted balls when coming back from surgery. Instead, “we’re shutting them down,” he said.

Throwing any pitch is an act of violence on the body, Dr. Garrigues said, with the elbow taking the final brunt of the force. “These pitchers are functioning at the absolute limits of what the human body can take,” he said. “There’s only so many bullets in a gun,” which is why pitchers often feel the twinge of a torn UCL on a routine pitch.

Dr. Makhni suggested cross-training for pitchers in the off-season instead of playing baseball year-round. “If you play soccer, your footwork is going to be better,” he said.

“Kids shouldn’t be doing this all year round,” said Rebecca Carl, MD, associate professor of pediatrics at Northwestern University Feinberg School of Medicine in Chicago. “We are recommending that kids take 2 or 3 months off.” In the off-season, she urges them to strengthen their backs and cores. 

Such advice can “feel like a bombshell,” said Dr. Carl, who chairs the Council on Sports Medicine and Fitness for the American Academy of Pediatrics. ‘Some started at a very young age. They go to camps. If I say to a teenager, ‘If you do this, I can keep you from getting injured,’ they think, ‘I won’t be injured.’” Most parents, however, understand the risk of “doing too much, too soon.”

Justin Orenduff, a former pitching prospect until his arm blew out, has made a career teaching head-to-toe pitching mechanics. He founded DVS Baseball, which uses software to teach pitchers how to properly use every muscle, starting with the orientation of the back foot. He, too, argues against pitching year-round. “Everyone on that travel team expects to get their fair share of playing time,” he said. “It just never stops.”

Organized baseball is paying attention. It has come up with the Pitch Smart program that gives maximum pitch counts for young players, but experts said children often get around that by belonging to several leagues.

Dr. Altchek said some surgeons have added platelet-rich plasma, stem cells, and bone marrow during surgery to quicken the slow healing time from UCL replacement. But he said, “it has to heal. Can you speed up biology?”

Dr. McCulloch said that, all the advances in Tommy John surgery aside, “the next frontier is really trying to crack the code on prevention.”

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

In 1974, Tommy John of the Los Angeles Dodgers was 31 and a 12-year veteran of Major League Baseball when he became the unwitting vanguard of a revolution in baseball and orthopedics. Fifty years later, Mr. John might not be a candidate for the latest advances to a procedure that bears his name.

The southpaw pitcher had faced the abrupt end of his career when, after one fateful delivery, he found himself unable to throw to home. So he took a gamble on the surgical equivalent of a Hail Mary: the reconstruction of a torn ligament in his pitching elbow.

The experiment was a wild success. Mr. John pitched— and better than he had before — for another 14 seasons, retiring in 1989 at the age of 46. How much better? After the surgery, he tallied three 20-win seasons compared with none before the operation, and he finished among the top five vote-getters for the annual Cy Young Award three times. He was named an All-Star once before the surgery and three times after.

The triumph notwithstanding, Tommy John now cautions against Tommy John surgery. What’s given him and clinicians pause is a trend in recent years of ever-younger athletes who undergo the procedure.

Along with the surgical improvements in repairing a torn ulnar collateral ligament (UCL) is a demographic shift toward school-aged athletes who get it. By 2014, one study concluded that 67.4% of UCL reconstruction surgeries were performed on athletes between 16 and 20 years of age. Some patients are still in Little League when they undergo the procedure.

Experts say these athletes have weakened their UCLs through overuse. They disagree on whether to call it an “epidemic,” but if it is, “the vaccine is awareness” against throwing too hard and too often, said Eric Makhni, MD, an orthopedic surgeon at Henry Ford Health in Detroit.
 

From Career-Ending to Routine

Mr. John’s entry into baseball and orthopedic lore was initially slow, but the trickle turned into a tide. After Frank Jobe, MD, swapped a healthy tendon from John’s right wrist for his worn and torn left UCL on September 25, 1974, he didn’t perform his second surgery for another 1194 days. By the time “Tommy John surgery” became a recognized phrase, Mr. John was still active but only 14 professional baseball players had undergone the operation.

Prior to the start of spring training this year, an oft-cited database listed 366 pro players who’d undergone the operation. 

“Before Tommy John, that was a career-ending injury,” said Grant E. Garrigues, MD, an orthopedic surgeon at Midwest Orthopaedics at RUSH in Chicago, who called Mr. John “a pure revolutionary.”

Tommy John surgery is “the only one that I can think of that is named after the patient rather than the doctor who first did it,” said Patrick McCulloch, MD, an orthopedic surgeon in Houston and a team physician for the Astros.

Dr. McCulloch, who performs about 25 UCL repairs a year, said that by recent estimates, one-third of pro pitchers had had some sort of surgical repair. He hesitated to call the increasing number of operations an epidemic but acknowledged that the ingredients exist for more elbow trauma among baseball players.

“More people are playing more often, and people are bigger and stronger and throwing harder,” he said.

Either way, Dr. McCulloch said, “the procedure is a victim of its own success” because it is “just done phenomenally well.”

The surgery is now commonplace — perhaps too commonplace, said David W. Altchek, MD, attending surgeon and co-chief emeritus at Hospital for Special Surgery in New York City.

Dr. Altchek played a key role in the popularity of the operation. Twenty-two years after Mr. John’s surgery, he helped develop a variation of the procedure called the docking technique. 

Whereas Dr. Jobe sutured Mr. John’s replacement graft to itself, “we developed a different way of tying it over a bone bridge, which was more secure and more easy to tension,” Dr. Altchek explained.

The advance meant less drilling into bone and enabled surgeons to avoid moving a problem-free ulnar nerve or removing the flexor-pronator muscle that protects the elbow from stress. “The trauma of the surgery is significantly less,” he said. “We just made it a lot easier very quickly,” cutting the surgery time from 2 hours to 30-40 minutes.

Maybe the surgery became too easy, said Dr. Altchek, who estimates he has done 2000 of them over the past 30 years. “I don’t want to condemn my colleagues, but there are a lot of people doing the surgery,” he said. “And not a lot of people are doing a lot of them, and they don’t know the nuances of doing the surgery.”

The older procedures are known as the “full Tommy John”; each has a 12- to 18-month healing process, with a success rate of 80%-85%. Pitchers typically sit out a season while recovering.

Brandon Erickson, MD, an orthopedic surgeon at Rothman Orthopaedic Institute in New York City, said that in younger patients he has recently turned more often to the suture of the future: an internal brace that provides a repair rather than reconstruction.

The procedure, pioneered by Felix H. Savoie III, MD, the Ray J. Haddad Professor of Orthopaedics at Tulane University School of Medicine in New Orleans, and Jeffrey R. Dugas, MD, of Andrews Sports Medicine & Orthopaedic Center in Birmingham, Alabama, uses collagen-coated tape that looks like a shoelace and provides a scaffold that Dr. McCulloch said “is inductive to healing and growth of ligament tissue.”

The brace is intended for an “overhead” athlete (mostly baseball players but also javelin throwers and gymnasts) whose UCL is torn on only one side but is otherwise in good shape. In a pitcher the same age as Mr. John was when Dr. Jobe performed the first procedure, “that ligament may not be of very good quality,” Dr. McCulloch said. “It may have thickened. It may have calcifications.” But for a high-school junior with aspirations to pitch in college or beyond without “way too many miles on the elbow,” the approach is a good fit. The healing process is as little as 6 months.

“The ones who have a good ligament are very likely to do well,” said Dr. Erickson, an assistant team doctor for the Philadelphia Phillies.

“If the patient’s ligament is generally ‘good’ with only a tear, the InternalBrace procedure may be used to repair the native ligament. On the other end of the spectrum, if the patient’s ligament is torn and degenerative the surgeon may opt to do a UCL reconstruction using an auto or allograft — ie, Tommy John surgery,” Allen Holowecky, senior product manager of Arthrex of Naples, Florida, the maker of the InternalBrace, told this news organization. “Before UCL repair, Tommy John surgery was the only real treatment option. We tend to see repairs done on younger patients since their ligament hasn’t seen years of use-damage.”
 

Calls for Caution

Tommy John III wanted to play baseball like his dad until near-fatal complications from shoulder surgery altered his path. He was drawn to chiropractic and consults on injury prevention. “All surgeries and all medical interventions are cut first, ask questions later,” he said. “I was born with that.”

He saw his dad’s slow, heroic comeback from the surgery and described him as the perfect candidate for Dr. Jobe’s experiment. Tommy John spent his recovery time squeezing Silly Putty and throwing tennis balls. “He was willing to do anything necessary. He wanted to throw. That was his brush.” When the son was recovering from his own injury, “he said, ‘Learn the knuckleball.’ I said, ‘I don’t want to. I’ve reached my point.’ ”

He said he tells young patients with UCL injuries to rest. But instead “we have year-round sports with the promise that the more you play, the better,” he said. “They’re over-activitied.”

According to the American Academy of Orthopaedic Surgeons, 6.4 million children and adolescents in the United States played organized baseball in 2022, down from 11.5 million in 2014. Nearly half of pitchers played in a league with no maximum pitch counts, and 43.5% pitched on consecutive days, the group said.

How many UCL repair or reconstruction surgeries are performed on youth athletes each year is unclear. A 2019 study, however, found that although baseball injuries decreased between 2006 and 2016, the elbow was “the only location of injury that saw an increase.”

Dr. Garrigues said some parents of throwing athletes have asked about prophylactic Tommy John surgery for their children. He said it shouldn’t apply to pitchers.

“People have taken it a little too far,” he said. Dr. Garrigues and others argue against children throwing weighted balls when coming back from surgery. Instead, “we’re shutting them down,” he said.

Throwing any pitch is an act of violence on the body, Dr. Garrigues said, with the elbow taking the final brunt of the force. “These pitchers are functioning at the absolute limits of what the human body can take,” he said. “There’s only so many bullets in a gun,” which is why pitchers often feel the twinge of a torn UCL on a routine pitch.

Dr. Makhni suggested cross-training for pitchers in the off-season instead of playing baseball year-round. “If you play soccer, your footwork is going to be better,” he said.

“Kids shouldn’t be doing this all year round,” said Rebecca Carl, MD, associate professor of pediatrics at Northwestern University Feinberg School of Medicine in Chicago. “We are recommending that kids take 2 or 3 months off.” In the off-season, she urges them to strengthen their backs and cores. 

Such advice can “feel like a bombshell,” said Dr. Carl, who chairs the Council on Sports Medicine and Fitness for the American Academy of Pediatrics. ‘Some started at a very young age. They go to camps. If I say to a teenager, ‘If you do this, I can keep you from getting injured,’ they think, ‘I won’t be injured.’” Most parents, however, understand the risk of “doing too much, too soon.”

Justin Orenduff, a former pitching prospect until his arm blew out, has made a career teaching head-to-toe pitching mechanics. He founded DVS Baseball, which uses software to teach pitchers how to properly use every muscle, starting with the orientation of the back foot. He, too, argues against pitching year-round. “Everyone on that travel team expects to get their fair share of playing time,” he said. “It just never stops.”

Organized baseball is paying attention. It has come up with the Pitch Smart program that gives maximum pitch counts for young players, but experts said children often get around that by belonging to several leagues.

Dr. Altchek said some surgeons have added platelet-rich plasma, stem cells, and bone marrow during surgery to quicken the slow healing time from UCL replacement. But he said, “it has to heal. Can you speed up biology?”

Dr. McCulloch said that, all the advances in Tommy John surgery aside, “the next frontier is really trying to crack the code on prevention.”

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

Teen pregnancy is associated with a higher risk for premature mortality, both among those who carry the pregnancies to term and those who miscarry, according to a new study.

Among 2.2 million female teenagers in Ontario, Canada, the risk for premature death by age 31 years was 1.5 times higher among those who had one teen pregnancy and 2.1 times higher among those with two or more teen pregnancies.

“No person should die during childhood or early adulthood. Such deaths, unexpected and tragic, are often from preventable causes, including intentional injury,” lead author Joel Ray, MD, an obstetric medicine specialist and epidemiologist at St. Michael’s Hospital in Toronto, told this news organization. 

“Women who experience teen pregnancy appear more vulnerable, often having experienced a history of adverse experiences in childhood, including abuse and economic challenges,” he said.

The study was published online in JAMA Network Open.
 

Analyzing Pregnancy Associations

The investigators conducted a population-based cohort study of all girls who were alive at age 12 years from April 1991 to March 2021 in Ontario. They evaluated the risk for all-cause mortality from age 12 years onward in association with the number of teen pregnancies between ages 12 and 19 years and the age at first pregnancy. The investigators adjusted the hazard ratios for year of birth, comorbidities at ages 9-11 years, area-level education, income level, and rural status.

Among more than 2.2 million teens, 163,124 (7.3%) had a pregnancy at a median age of 18 years, including 121,276 (74.3%) who had one pregnancy and 41,848 (25.6%) who had two or more. These teens were more likely to live in the lowest neighborhood income quintile and in an area with a lower rate of high school completion. They also had a higher prevalence of self-harm history between ages 12 and 19 years but not a higher prevalence of physical or mental comorbidities.

Among all teens who had a pregnancy, 60,037 (36.8%) ended in a birth, including 59,485 (99.1%) live births. A further 106,135 (65.1%) ended in induced abortion, and 17,945 (11%) ended in miscarriage or ectopic pregnancy.

Overall, there were 6030 premature deaths among those without a teen pregnancy, or 1.9 per 10,000 person-years. There were 701 deaths among those with one teen pregnancy (4.1 per 10,000 person-years) and 345 deaths among those with two or more teen pregnancies (6.1 per 10,000 person-years).

The adjusted hazard ratios (AHRs) for mortality were 1.51 for those with one pregnancy and 2.14 for those with two or more pregnancies. Compared with no teen pregnancy, the AHRs for premature death were 1.41 if the first teen pregnancy ended in an induced abortion and 2.10 if it ended in a miscarriage or birth.

Comparing those with a teen pregnancy and those without, the AHRs for premature death were 1.25 from noninjury, 2.06 from unintentional injury, and 2.02 from intentional injury. Among patients with teen pregnancy, noninjury-related premature mortality was more common, at 2.0 per 10,000 person-years, than unintentional and intentional injuries, at 1.0 per 10,000 person-years and 0.4 per 10,000 person-years, respectively.

A teen pregnancy before age 16 years entailed the highest associated risk for premature death, with an AHR of 2.00.
 

Next Research Steps

“We were not surprised by our findings, but it was new to us to see that the risk for premature death was higher for women who had an induced abortion in their teen years,” said Dr. Ray. “It was even higher in those whose pregnancy ended in a birth or miscarriage.”

The investigators plan to evaluate whether the future risk for premature death after teen pregnancy differs by the type of induced abortion, such as procedural or pharmaceutical, or by whether the pregnancy ended in a live birth, stillbirth, or miscarriage. Among those with a live birth, the researchers will also analyze the risk for premature death in relation to whether the newborn was taken into custody by child protection services in Canada.

Other factors associated with teen pregnancy and overall mortality, particularly adverse childhood experiences, may point to the reasons for premature mortality and should be studied further, the authors wrote. Structural and systems-related factors should be considered as well.
 

Stigmatization and Isolation 

“Some teens choose to become pregnant, but most teen pregnancies are unintended, which exposes shortcomings in the systems that exist to educate, guide, and support young people,” said Elizabeth Cook, a research scientist at Child Trends in Rockville, Maryland.

Dr. Cook, who wasn’t involved with this study, wrote an accompanying editorial in JAMA Network Open. She conducts studies of sexual and reproductive health for Child Trends.

“Teens who become pregnant often experience stigmatization and isolation that can make it more difficult to thrive in adulthood, especially if they lack the necessary support to navigate such a significant decision,” she said. “Fortunately, the systems that youths encounter, such as healthcare, education, and child welfare, are taking on a larger role in prevention efforts than they have in the past.”

These systems are shifting the burden of unintended teen pregnancy from the teens themselves and their behaviors to the health and education systems, Dr. Cook noted, though more work is needed around local policies and lack of access to healthcare facilities. 

“Teen pregnancy may offer an opportunity to intervene in the lives of people at higher risk for premature death, but knowing how best to offer support requires an understanding of the context of their lives,” she said. “As a starting point, we must celebrate and listen to all pregnant young people so they can tell us what they need to live long, fulfilled lives.”

The study was funded by grants from the PSI Foundation and the Canadian Institutes of Health Research, as well as ICES, which is funded by the Ontario Ministry of Health and the Ministry of Long-Term Care. Dr. Ray and Dr. Cook reported no relevant disclosures. 

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

Teen pregnancy is associated with a higher risk for premature mortality, both among those who carry the pregnancies to term and those who miscarry, according to a new study.

Among 2.2 million female teenagers in Ontario, Canada, the risk for premature death by age 31 years was 1.5 times higher among those who had one teen pregnancy and 2.1 times higher among those with two or more teen pregnancies.

“No person should die during childhood or early adulthood. Such deaths, unexpected and tragic, are often from preventable causes, including intentional injury,” lead author Joel Ray, MD, an obstetric medicine specialist and epidemiologist at St. Michael’s Hospital in Toronto, told this news organization. 

“Women who experience teen pregnancy appear more vulnerable, often having experienced a history of adverse experiences in childhood, including abuse and economic challenges,” he said.

The study was published online in JAMA Network Open.
 

Analyzing Pregnancy Associations

The investigators conducted a population-based cohort study of all girls who were alive at age 12 years from April 1991 to March 2021 in Ontario. They evaluated the risk for all-cause mortality from age 12 years onward in association with the number of teen pregnancies between ages 12 and 19 years and the age at first pregnancy. The investigators adjusted the hazard ratios for year of birth, comorbidities at ages 9-11 years, area-level education, income level, and rural status.

Among more than 2.2 million teens, 163,124 (7.3%) had a pregnancy at a median age of 18 years, including 121,276 (74.3%) who had one pregnancy and 41,848 (25.6%) who had two or more. These teens were more likely to live in the lowest neighborhood income quintile and in an area with a lower rate of high school completion. They also had a higher prevalence of self-harm history between ages 12 and 19 years but not a higher prevalence of physical or mental comorbidities.

Among all teens who had a pregnancy, 60,037 (36.8%) ended in a birth, including 59,485 (99.1%) live births. A further 106,135 (65.1%) ended in induced abortion, and 17,945 (11%) ended in miscarriage or ectopic pregnancy.

Overall, there were 6030 premature deaths among those without a teen pregnancy, or 1.9 per 10,000 person-years. There were 701 deaths among those with one teen pregnancy (4.1 per 10,000 person-years) and 345 deaths among those with two or more teen pregnancies (6.1 per 10,000 person-years).

The adjusted hazard ratios (AHRs) for mortality were 1.51 for those with one pregnancy and 2.14 for those with two or more pregnancies. Compared with no teen pregnancy, the AHRs for premature death were 1.41 if the first teen pregnancy ended in an induced abortion and 2.10 if it ended in a miscarriage or birth.

Comparing those with a teen pregnancy and those without, the AHRs for premature death were 1.25 from noninjury, 2.06 from unintentional injury, and 2.02 from intentional injury. Among patients with teen pregnancy, noninjury-related premature mortality was more common, at 2.0 per 10,000 person-years, than unintentional and intentional injuries, at 1.0 per 10,000 person-years and 0.4 per 10,000 person-years, respectively.

A teen pregnancy before age 16 years entailed the highest associated risk for premature death, with an AHR of 2.00.
 

Next Research Steps

“We were not surprised by our findings, but it was new to us to see that the risk for premature death was higher for women who had an induced abortion in their teen years,” said Dr. Ray. “It was even higher in those whose pregnancy ended in a birth or miscarriage.”

The investigators plan to evaluate whether the future risk for premature death after teen pregnancy differs by the type of induced abortion, such as procedural or pharmaceutical, or by whether the pregnancy ended in a live birth, stillbirth, or miscarriage. Among those with a live birth, the researchers will also analyze the risk for premature death in relation to whether the newborn was taken into custody by child protection services in Canada.

Other factors associated with teen pregnancy and overall mortality, particularly adverse childhood experiences, may point to the reasons for premature mortality and should be studied further, the authors wrote. Structural and systems-related factors should be considered as well.
 

Stigmatization and Isolation 

“Some teens choose to become pregnant, but most teen pregnancies are unintended, which exposes shortcomings in the systems that exist to educate, guide, and support young people,” said Elizabeth Cook, a research scientist at Child Trends in Rockville, Maryland.

Dr. Cook, who wasn’t involved with this study, wrote an accompanying editorial in JAMA Network Open. She conducts studies of sexual and reproductive health for Child Trends.

“Teens who become pregnant often experience stigmatization and isolation that can make it more difficult to thrive in adulthood, especially if they lack the necessary support to navigate such a significant decision,” she said. “Fortunately, the systems that youths encounter, such as healthcare, education, and child welfare, are taking on a larger role in prevention efforts than they have in the past.”

These systems are shifting the burden of unintended teen pregnancy from the teens themselves and their behaviors to the health and education systems, Dr. Cook noted, though more work is needed around local policies and lack of access to healthcare facilities. 

“Teen pregnancy may offer an opportunity to intervene in the lives of people at higher risk for premature death, but knowing how best to offer support requires an understanding of the context of their lives,” she said. “As a starting point, we must celebrate and listen to all pregnant young people so they can tell us what they need to live long, fulfilled lives.”

The study was funded by grants from the PSI Foundation and the Canadian Institutes of Health Research, as well as ICES, which is funded by the Ontario Ministry of Health and the Ministry of Long-Term Care. Dr. Ray and Dr. Cook reported no relevant disclosures. 

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

Teen pregnancy is associated with a higher risk for premature mortality, both among those who carry the pregnancies to term and those who miscarry, according to a new study.

Among 2.2 million female teenagers in Ontario, Canada, the risk for premature death by age 31 years was 1.5 times higher among those who had one teen pregnancy and 2.1 times higher among those with two or more teen pregnancies.

“No person should die during childhood or early adulthood. Such deaths, unexpected and tragic, are often from preventable causes, including intentional injury,” lead author Joel Ray, MD, an obstetric medicine specialist and epidemiologist at St. Michael’s Hospital in Toronto, told this news organization. 

“Women who experience teen pregnancy appear more vulnerable, often having experienced a history of adverse experiences in childhood, including abuse and economic challenges,” he said.

The study was published online in JAMA Network Open.
 

Analyzing Pregnancy Associations

The investigators conducted a population-based cohort study of all girls who were alive at age 12 years from April 1991 to March 2021 in Ontario. They evaluated the risk for all-cause mortality from age 12 years onward in association with the number of teen pregnancies between ages 12 and 19 years and the age at first pregnancy. The investigators adjusted the hazard ratios for year of birth, comorbidities at ages 9-11 years, area-level education, income level, and rural status.

Among more than 2.2 million teens, 163,124 (7.3%) had a pregnancy at a median age of 18 years, including 121,276 (74.3%) who had one pregnancy and 41,848 (25.6%) who had two or more. These teens were more likely to live in the lowest neighborhood income quintile and in an area with a lower rate of high school completion. They also had a higher prevalence of self-harm history between ages 12 and 19 years but not a higher prevalence of physical or mental comorbidities.

Among all teens who had a pregnancy, 60,037 (36.8%) ended in a birth, including 59,485 (99.1%) live births. A further 106,135 (65.1%) ended in induced abortion, and 17,945 (11%) ended in miscarriage or ectopic pregnancy.

Overall, there were 6030 premature deaths among those without a teen pregnancy, or 1.9 per 10,000 person-years. There were 701 deaths among those with one teen pregnancy (4.1 per 10,000 person-years) and 345 deaths among those with two or more teen pregnancies (6.1 per 10,000 person-years).

The adjusted hazard ratios (AHRs) for mortality were 1.51 for those with one pregnancy and 2.14 for those with two or more pregnancies. Compared with no teen pregnancy, the AHRs for premature death were 1.41 if the first teen pregnancy ended in an induced abortion and 2.10 if it ended in a miscarriage or birth.

Comparing those with a teen pregnancy and those without, the AHRs for premature death were 1.25 from noninjury, 2.06 from unintentional injury, and 2.02 from intentional injury. Among patients with teen pregnancy, noninjury-related premature mortality was more common, at 2.0 per 10,000 person-years, than unintentional and intentional injuries, at 1.0 per 10,000 person-years and 0.4 per 10,000 person-years, respectively.

A teen pregnancy before age 16 years entailed the highest associated risk for premature death, with an AHR of 2.00.
 

Next Research Steps

“We were not surprised by our findings, but it was new to us to see that the risk for premature death was higher for women who had an induced abortion in their teen years,” said Dr. Ray. “It was even higher in those whose pregnancy ended in a birth or miscarriage.”

The investigators plan to evaluate whether the future risk for premature death after teen pregnancy differs by the type of induced abortion, such as procedural or pharmaceutical, or by whether the pregnancy ended in a live birth, stillbirth, or miscarriage. Among those with a live birth, the researchers will also analyze the risk for premature death in relation to whether the newborn was taken into custody by child protection services in Canada.

Other factors associated with teen pregnancy and overall mortality, particularly adverse childhood experiences, may point to the reasons for premature mortality and should be studied further, the authors wrote. Structural and systems-related factors should be considered as well.
 

Stigmatization and Isolation 

“Some teens choose to become pregnant, but most teen pregnancies are unintended, which exposes shortcomings in the systems that exist to educate, guide, and support young people,” said Elizabeth Cook, a research scientist at Child Trends in Rockville, Maryland.

Dr. Cook, who wasn’t involved with this study, wrote an accompanying editorial in JAMA Network Open. She conducts studies of sexual and reproductive health for Child Trends.

“Teens who become pregnant often experience stigmatization and isolation that can make it more difficult to thrive in adulthood, especially if they lack the necessary support to navigate such a significant decision,” she said. “Fortunately, the systems that youths encounter, such as healthcare, education, and child welfare, are taking on a larger role in prevention efforts than they have in the past.”

These systems are shifting the burden of unintended teen pregnancy from the teens themselves and their behaviors to the health and education systems, Dr. Cook noted, though more work is needed around local policies and lack of access to healthcare facilities. 

“Teen pregnancy may offer an opportunity to intervene in the lives of people at higher risk for premature death, but knowing how best to offer support requires an understanding of the context of their lives,” she said. “As a starting point, we must celebrate and listen to all pregnant young people so they can tell us what they need to live long, fulfilled lives.”

The study was funded by grants from the PSI Foundation and the Canadian Institutes of Health Research, as well as ICES, which is funded by the Ontario Ministry of Health and the Ministry of Long-Term Care. Dr. Ray and Dr. Cook reported no relevant disclosures. 

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

TOPLINE:

Certain stimulants prescribed for attention-deficit/hyperactivity disorder (ADHD) are associated with a decreased risk for psychiatric and nonpsychiatric hospitalization and suicide, new data from a national cohort study showed.

METHODOLOGY:

• Investigators used various medical and administrative databases in Sweden to identify individuals aged 16-65 years who were diagnosed with ADHD between January 2006 and December 2021.
• Participants were followed for up to 15 years (mean duration, 7 years) from date of diagnosis until death, emigration, or end of data linkage in December 2021.
• Researchers wanted to explore the link between ADHD meds and psychiatric hospitalization, nonpsychiatric hospitalization, and suicidal behavior.

TAKEAWAY:

• The cohort included 221,700 individuals with ADHD (mean age, 25 years; 54% male), and 56% had a psychiatric comorbidity such as an anxiety or stress-related disorder (24%), and depression or bipolar disorder (20%).
• Investigators found significantly lower risk for psychiatric hospitalization for the several medications. These included amphetamine (adjusted hazard ratio [aHR], 0.74), lisdexamphetamine (aHR, 0.80), dexamphetamine (aHR, 0.88), methylphenidate (aHR, 0.93), and polytherapy (aHR, 0.85). All but atomoxetine was significant at the P < .001 level.
• ADHD medications associated with a significantly lower risk for nonpsychiatric hospitalization included amphetamine (aHR, 0.62), lisdexamphetamine (aHR, 0.64), polytherapy (aHR, 0.67), dexamphetamine (aHR, 0.72), methylphenidate (aHR, 0.80), and atomoxetine (aHR, 0.84). All but atomoxetine was significant at the P < .001 level.
• Use of dexamphetamine (aHR, 0.69; P < .001), lisdexamphetamine (aHR, 0.76; P = .43), polytherapy (aHR, 0.85; P = .02), and methylphenidate (aHR, 0.92; P = .007) were associated with a significantly lower risk for suicidal behavior.

IN PRACTICE:

“Although concerns have been raised about the potential of amphetamines and methylphenidate for increasing the risk of adverse psychiatric outcomes, such as psychosis and mania, our results show that overall, the net effect on psychiatric outcomes is positive,” study authors wrote.

SOURCE:

Heidi Taipale, PhD, of Karolinska Institutet, led the study, which was published online in JAMA Network Open. 

LIMITATIONS:

Due to the use of nationwide registers, there was a lack of detailed clinical data, including type and severity of symptoms. There was also no data on nonpharmacologic treatments.

DISCLOSURES:

The study was funded by the AFA Insurance Agency. Dr. Taipale reported receiving personal fees from Gedeon Richter, Janssen, Lundbeck, and Otsuka and grants from Janssen and Eli Lilly outside of the submitted work. Other disclosures are noted in the original article.

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

TOPLINE:

Certain stimulants prescribed for attention-deficit/hyperactivity disorder (ADHD) are associated with a decreased risk for psychiatric and nonpsychiatric hospitalization and suicide, new data from a national cohort study showed.

METHODOLOGY:

• Investigators used various medical and administrative databases in Sweden to identify individuals aged 16-65 years who were diagnosed with ADHD between January 2006 and December 2021.
• Participants were followed for up to 15 years (mean duration, 7 years) from date of diagnosis until death, emigration, or end of data linkage in December 2021.
• Researchers wanted to explore the link between ADHD meds and psychiatric hospitalization, nonpsychiatric hospitalization, and suicidal behavior.

TAKEAWAY:

• The cohort included 221,700 individuals with ADHD (mean age, 25 years; 54% male), and 56% had a psychiatric comorbidity such as an anxiety or stress-related disorder (24%), and depression or bipolar disorder (20%).
• Investigators found significantly lower risk for psychiatric hospitalization for the several medications. These included amphetamine (adjusted hazard ratio [aHR], 0.74), lisdexamphetamine (aHR, 0.80), dexamphetamine (aHR, 0.88), methylphenidate (aHR, 0.93), and polytherapy (aHR, 0.85). All but atomoxetine was significant at the P < .001 level.
• ADHD medications associated with a significantly lower risk for nonpsychiatric hospitalization included amphetamine (aHR, 0.62), lisdexamphetamine (aHR, 0.64), polytherapy (aHR, 0.67), dexamphetamine (aHR, 0.72), methylphenidate (aHR, 0.80), and atomoxetine (aHR, 0.84). All but atomoxetine was significant at the P < .001 level.
• Use of dexamphetamine (aHR, 0.69; P < .001), lisdexamphetamine (aHR, 0.76; P = .43), polytherapy (aHR, 0.85; P = .02), and methylphenidate (aHR, 0.92; P = .007) were associated with a significantly lower risk for suicidal behavior.

IN PRACTICE:

“Although concerns have been raised about the potential of amphetamines and methylphenidate for increasing the risk of adverse psychiatric outcomes, such as psychosis and mania, our results show that overall, the net effect on psychiatric outcomes is positive,” study authors wrote.

SOURCE:

Heidi Taipale, PhD, of Karolinska Institutet, led the study, which was published online in JAMA Network Open. 

LIMITATIONS:

Due to the use of nationwide registers, there was a lack of detailed clinical data, including type and severity of symptoms. There was also no data on nonpharmacologic treatments.

DISCLOSURES:

The study was funded by the AFA Insurance Agency. Dr. Taipale reported receiving personal fees from Gedeon Richter, Janssen, Lundbeck, and Otsuka and grants from Janssen and Eli Lilly outside of the submitted work. Other disclosures are noted in the original article.

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

TOPLINE:

Certain stimulants prescribed for attention-deficit/hyperactivity disorder (ADHD) are associated with a decreased risk for psychiatric and nonpsychiatric hospitalization and suicide, new data from a national cohort study showed.

METHODOLOGY:

• Investigators used various medical and administrative databases in Sweden to identify individuals aged 16-65 years who were diagnosed with ADHD between January 2006 and December 2021.
• Participants were followed for up to 15 years (mean duration, 7 years) from date of diagnosis until death, emigration, or end of data linkage in December 2021.
• Researchers wanted to explore the link between ADHD meds and psychiatric hospitalization, nonpsychiatric hospitalization, and suicidal behavior.

TAKEAWAY:

• The cohort included 221,700 individuals with ADHD (mean age, 25 years; 54% male), and 56% had a psychiatric comorbidity such as an anxiety or stress-related disorder (24%), and depression or bipolar disorder (20%).
• Investigators found significantly lower risk for psychiatric hospitalization for the several medications. These included amphetamine (adjusted hazard ratio [aHR], 0.74), lisdexamphetamine (aHR, 0.80), dexamphetamine (aHR, 0.88), methylphenidate (aHR, 0.93), and polytherapy (aHR, 0.85). All but atomoxetine was significant at the P < .001 level.
• ADHD medications associated with a significantly lower risk for nonpsychiatric hospitalization included amphetamine (aHR, 0.62), lisdexamphetamine (aHR, 0.64), polytherapy (aHR, 0.67), dexamphetamine (aHR, 0.72), methylphenidate (aHR, 0.80), and atomoxetine (aHR, 0.84). All but atomoxetine was significant at the P < .001 level.
• Use of dexamphetamine (aHR, 0.69; P < .001), lisdexamphetamine (aHR, 0.76; P = .43), polytherapy (aHR, 0.85; P = .02), and methylphenidate (aHR, 0.92; P = .007) were associated with a significantly lower risk for suicidal behavior.

IN PRACTICE:

“Although concerns have been raised about the potential of amphetamines and methylphenidate for increasing the risk of adverse psychiatric outcomes, such as psychosis and mania, our results show that overall, the net effect on psychiatric outcomes is positive,” study authors wrote.

SOURCE:

Heidi Taipale, PhD, of Karolinska Institutet, led the study, which was published online in JAMA Network Open. 

LIMITATIONS:

Due to the use of nationwide registers, there was a lack of detailed clinical data, including type and severity of symptoms. There was also no data on nonpharmacologic treatments.

DISCLOSURES:

The study was funded by the AFA Insurance Agency. Dr. Taipale reported receiving personal fees from Gedeon Richter, Janssen, Lundbeck, and Otsuka and grants from Janssen and Eli Lilly outside of the submitted work. Other disclosures are noted in the original article.

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

Nine days after the independent laboratory Valisure petitioned the Food and Drug Administration (FDA) to recall acne products with benzoyl peroxide (BP) because of the lab’s findings of extremely high levels of the carcinogen benzene, it published another report in Environmental Health Perspectives (EHP), on March 14, also warning about BP acne products.

The bottom line was the same: The laboratory, based in New Haven, Connecticut, said its analyses raise substantial concerns about the safety of BP-containing acne products currently on the market.

The lab’s results showed that the products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) of benzene, with both prescription and over-the-counter products affected.

“This is a problem of degradation, not contamination,” David Light, CEO and founder of Valisure, said in a telephone interview. BP can decompose into benzene, and exposure to benzene has been linked with a higher risk for leukemia and other blood cancers, according to the American Cancer Society.

In the wake of the findings, however, debate has erupted over the method and approach used by Valisure to test these products, with critics and companies contending that more “real-world” use data are needed. And the US Pharmacopeia (USP) is asking for full transparency about the testing methods.

In a March 8 statement, USP said the petition indicated that modified USP methods were used in the study, noting that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

However, Valisure contended that drug products need to demonstrate stability over the entire life cycle, from shipment to continued use, emphasizing that constitutes the best “real-world” approach. It also defended the methodology it used.

The reports have led to a state of uncertainty about the use of BP products.

“Right now, we have more unknowns than anything else,” John Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said in a video posted on X and YouTube, summarizing the findings released by Valisure on March 6 and 14. He was not involved in the Valisure research.

Barbieri_John2024_Boston_web.jpg

In a telephone interview, Dr. Barbieri said the report “needs to be taken seriously,” but he also believed the Valisure report is lacking information about testing under “real-world” conditions. He is calling for more information and more transparency about the data. What’s clear, Dr. Barbieri told this news organization, is that the findings about high benzene levels are not a manufacturing error. “It’s something to do with the molecule itself.”
 

Valisure’s Analyses

Valisure performed an initial analysis, using a method called gas chromatography-mass spectrometry, which is the FDA-preferred method for detecting benzene, Mr. Light said. It tested 175 acne products, 99 containing BP and 76 with other ingredients, such as salicylic acid. All the products without BP had no detectable benzene or values below 2 ppm, the FDA concentration limit for benzene.

Of the 99 BP products, 94 contained benzene without any elevated temperature incubation, according to Valisure. Using 50 °C (122 °F, the accepted pharmaceutical stability testing temperature) on 66 products, Valisure detected over 1500 ppm of benzene in two products, over 100 ppm in 17 products, and over 10 ppm in 42 products over an 18-day period.

The analysis confirmed, Valisure said in a press release and the petition, that a substantial amount of benzene can form in a BP product and leak outside the packaging into surrounding air.

The EHP paper, which includes authors from Valisure, reported that researchers took single lots of seven branded BP products, namely, Equate Beauty 2.5% BP cleansers, Neutrogena 10% BP cleanser, CVS Health 10% BP face wash, Walgreens 10% BP cream, Clean & Clear 10% cleanser, Equate Beauty 10% BP acne wash, and Proactiv 2.5% BP cleanser.

Using testing that involved gas chromatography-mass spectrometry, benzene was detected in all the BP products samples tested, and levels increased during incubation at body and shelf-life performance temperatures to more than 2 ppm. The authors concluded that the study “raises substantial concerns” about the safety of BP products currently on the market.
 

Methodology Debates

Two days after Valisure released its analysis on March 6, the USP reviewed the citizen’s petition filed by Valisure and called for more transparency around the testing methods.

“The petition referenced USP and indicated that modified USP methods and procedures were used in the study. The presence of unsafe levels of benzene should be taken seriously,” the statement said. The USP statement also noted that the Valisure analysis used modified USP methods and said that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

In its statement, USP took issue with a practice known as accelerated thermal degradation, which it said Valisure used. USP said the approach involves raising the storage temperature of a product to higher than the temperature indicated on the label for the purpose of simulating degradation over a longer period. While the approach may be acceptable, USP said, the temperatures chosen may not be what is expected to happen to the products.

In response, Mr. Light of Valisure referenced guidance issued in August, 2020, from the FDA, stating that the method it used in the BP analysis can be used to detect impurities in hand sanitizers, including benzene. (In 2021, Valisure detected high levels of benzene in some hand sanitizers and asked the FDA to take action.)
 

Company Response

Among the companies that took issue with the report was Reckitt, which makes Clearasil, which contains BP. In a statement, the company said, in part: “The products and their ingredients are stable over the storage conditions described on their packaging which represent all reasonable and foreseeable conditions.” It said the findings presented by Valisure reflect “unrealistic scenarios rather than real-world conditions.”

The Personal Care Products Council, a national trade association that represents cosmetic and personal care product manufacturers, also took issue with the findings and the approach used to evaluate the products.
 

FDA and the Citizen’s Petition

The FDA accepted the petition, Mr. Light said, and gave it a docket number. “We’ll hopefully hear more soon” because the FDA is required to respond to a citizen’s petition within 180 days, he said.

“We generally don’t comment on pending citizens’ petitions,” an FDA spokesperson said in an email. “When we respond, we will respond directly to the petitioner and post the response in the designated agency public docket.”
 

Valisure’s Patent Application

Mr. Light and others have applied for a patent on methods of producing shelf-stable formulations to prevent degradation of BP to benzene.

“We saw the problem long before we had any sort of application,” Mr. Light said. The issue has been “known for decades.”
 

Role of BP Products for Acne

In the midst of uncertainty, “the first discussion is, do we want to use it?” Dr. Barbieri said in the interview. Some patients may want to avoid it altogether, until more data are available, including more verification of the findings, while others may be comfortable accepting the potential risk, he said.

“Benzoyl peroxide is one of our foundational acne treatments,” Dr. Barbieri said. In the American Academy of Dermatology updated guidelines on acne, published in January, 2024, strong recommendations were made for BP products, as well as topical retinoids, topical antibiotics, and oral doxycycline.

“When you take away BP, there’s no substitute for it,” Dr. Barbieri said. And if patients don’t get improvement with topicals, oral medications might be needed, and “these all have their own risks.”
 

In the Interim

Until more information is available, Dr. Barbieri is advising patients not to store the products at high temperatures or for a long time. Don’t keep the products past their expiration date, and perhaps keep products for a shorter time, “something like a month,” he said.

Those living in a hot climate might consider storing the products in the refrigerator, he said.

“We need more data from Valisure, from other groups that confirm their findings, and we need to hear from the FDA,” Dr. Barbieri said. “There’s a lot of uncertainty right now. But it’s important not to overreact.”

Dr. Barbieri had no relevant disclosures.


 

A version of this article appeared on Medscape.com.

Nine days after the independent laboratory Valisure petitioned the Food and Drug Administration (FDA) to recall acne products with benzoyl peroxide (BP) because of the lab’s findings of extremely high levels of the carcinogen benzene, it published another report in Environmental Health Perspectives (EHP), on March 14, also warning about BP acne products.

The bottom line was the same: The laboratory, based in New Haven, Connecticut, said its analyses raise substantial concerns about the safety of BP-containing acne products currently on the market.

The lab’s results showed that the products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) of benzene, with both prescription and over-the-counter products affected.

“This is a problem of degradation, not contamination,” David Light, CEO and founder of Valisure, said in a telephone interview. BP can decompose into benzene, and exposure to benzene has been linked with a higher risk for leukemia and other blood cancers, according to the American Cancer Society.

In the wake of the findings, however, debate has erupted over the method and approach used by Valisure to test these products, with critics and companies contending that more “real-world” use data are needed. And the US Pharmacopeia (USP) is asking for full transparency about the testing methods.

In a March 8 statement, USP said the petition indicated that modified USP methods were used in the study, noting that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

However, Valisure contended that drug products need to demonstrate stability over the entire life cycle, from shipment to continued use, emphasizing that constitutes the best “real-world” approach. It also defended the methodology it used.

The reports have led to a state of uncertainty about the use of BP products.

“Right now, we have more unknowns than anything else,” John Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said in a video posted on X and YouTube, summarizing the findings released by Valisure on March 6 and 14. He was not involved in the Valisure research.

Barbieri_John2024_Boston_web.jpg

In a telephone interview, Dr. Barbieri said the report “needs to be taken seriously,” but he also believed the Valisure report is lacking information about testing under “real-world” conditions. He is calling for more information and more transparency about the data. What’s clear, Dr. Barbieri told this news organization, is that the findings about high benzene levels are not a manufacturing error. “It’s something to do with the molecule itself.”
 

Valisure’s Analyses

Valisure performed an initial analysis, using a method called gas chromatography-mass spectrometry, which is the FDA-preferred method for detecting benzene, Mr. Light said. It tested 175 acne products, 99 containing BP and 76 with other ingredients, such as salicylic acid. All the products without BP had no detectable benzene or values below 2 ppm, the FDA concentration limit for benzene.

Of the 99 BP products, 94 contained benzene without any elevated temperature incubation, according to Valisure. Using 50 °C (122 °F, the accepted pharmaceutical stability testing temperature) on 66 products, Valisure detected over 1500 ppm of benzene in two products, over 100 ppm in 17 products, and over 10 ppm in 42 products over an 18-day period.

The analysis confirmed, Valisure said in a press release and the petition, that a substantial amount of benzene can form in a BP product and leak outside the packaging into surrounding air.

The EHP paper, which includes authors from Valisure, reported that researchers took single lots of seven branded BP products, namely, Equate Beauty 2.5% BP cleansers, Neutrogena 10% BP cleanser, CVS Health 10% BP face wash, Walgreens 10% BP cream, Clean & Clear 10% cleanser, Equate Beauty 10% BP acne wash, and Proactiv 2.5% BP cleanser.

Using testing that involved gas chromatography-mass spectrometry, benzene was detected in all the BP products samples tested, and levels increased during incubation at body and shelf-life performance temperatures to more than 2 ppm. The authors concluded that the study “raises substantial concerns” about the safety of BP products currently on the market.
 

Methodology Debates

Two days after Valisure released its analysis on March 6, the USP reviewed the citizen’s petition filed by Valisure and called for more transparency around the testing methods.

“The petition referenced USP and indicated that modified USP methods and procedures were used in the study. The presence of unsafe levels of benzene should be taken seriously,” the statement said. The USP statement also noted that the Valisure analysis used modified USP methods and said that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

In its statement, USP took issue with a practice known as accelerated thermal degradation, which it said Valisure used. USP said the approach involves raising the storage temperature of a product to higher than the temperature indicated on the label for the purpose of simulating degradation over a longer period. While the approach may be acceptable, USP said, the temperatures chosen may not be what is expected to happen to the products.

In response, Mr. Light of Valisure referenced guidance issued in August, 2020, from the FDA, stating that the method it used in the BP analysis can be used to detect impurities in hand sanitizers, including benzene. (In 2021, Valisure detected high levels of benzene in some hand sanitizers and asked the FDA to take action.)
 

Company Response

Among the companies that took issue with the report was Reckitt, which makes Clearasil, which contains BP. In a statement, the company said, in part: “The products and their ingredients are stable over the storage conditions described on their packaging which represent all reasonable and foreseeable conditions.” It said the findings presented by Valisure reflect “unrealistic scenarios rather than real-world conditions.”

The Personal Care Products Council, a national trade association that represents cosmetic and personal care product manufacturers, also took issue with the findings and the approach used to evaluate the products.
 

FDA and the Citizen’s Petition

The FDA accepted the petition, Mr. Light said, and gave it a docket number. “We’ll hopefully hear more soon” because the FDA is required to respond to a citizen’s petition within 180 days, he said.

“We generally don’t comment on pending citizens’ petitions,” an FDA spokesperson said in an email. “When we respond, we will respond directly to the petitioner and post the response in the designated agency public docket.”
 

Valisure’s Patent Application

Mr. Light and others have applied for a patent on methods of producing shelf-stable formulations to prevent degradation of BP to benzene.

“We saw the problem long before we had any sort of application,” Mr. Light said. The issue has been “known for decades.”
 

Role of BP Products for Acne

In the midst of uncertainty, “the first discussion is, do we want to use it?” Dr. Barbieri said in the interview. Some patients may want to avoid it altogether, until more data are available, including more verification of the findings, while others may be comfortable accepting the potential risk, he said.

“Benzoyl peroxide is one of our foundational acne treatments,” Dr. Barbieri said. In the American Academy of Dermatology updated guidelines on acne, published in January, 2024, strong recommendations were made for BP products, as well as topical retinoids, topical antibiotics, and oral doxycycline.

“When you take away BP, there’s no substitute for it,” Dr. Barbieri said. And if patients don’t get improvement with topicals, oral medications might be needed, and “these all have their own risks.”
 

In the Interim

Until more information is available, Dr. Barbieri is advising patients not to store the products at high temperatures or for a long time. Don’t keep the products past their expiration date, and perhaps keep products for a shorter time, “something like a month,” he said.

Those living in a hot climate might consider storing the products in the refrigerator, he said.

“We need more data from Valisure, from other groups that confirm their findings, and we need to hear from the FDA,” Dr. Barbieri said. “There’s a lot of uncertainty right now. But it’s important not to overreact.”

Dr. Barbieri had no relevant disclosures.


 

A version of this article appeared on Medscape.com.

Nine days after the independent laboratory Valisure petitioned the Food and Drug Administration (FDA) to recall acne products with benzoyl peroxide (BP) because of the lab’s findings of extremely high levels of the carcinogen benzene, it published another report in Environmental Health Perspectives (EHP), on March 14, also warning about BP acne products.

The bottom line was the same: The laboratory, based in New Haven, Connecticut, said its analyses raise substantial concerns about the safety of BP-containing acne products currently on the market.

The lab’s results showed that the products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) of benzene, with both prescription and over-the-counter products affected.

“This is a problem of degradation, not contamination,” David Light, CEO and founder of Valisure, said in a telephone interview. BP can decompose into benzene, and exposure to benzene has been linked with a higher risk for leukemia and other blood cancers, according to the American Cancer Society.

In the wake of the findings, however, debate has erupted over the method and approach used by Valisure to test these products, with critics and companies contending that more “real-world” use data are needed. And the US Pharmacopeia (USP) is asking for full transparency about the testing methods.

In a March 8 statement, USP said the petition indicated that modified USP methods were used in the study, noting that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

However, Valisure contended that drug products need to demonstrate stability over the entire life cycle, from shipment to continued use, emphasizing that constitutes the best “real-world” approach. It also defended the methodology it used.

The reports have led to a state of uncertainty about the use of BP products.

“Right now, we have more unknowns than anything else,” John Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said in a video posted on X and YouTube, summarizing the findings released by Valisure on March 6 and 14. He was not involved in the Valisure research.

Barbieri_John2024_Boston_web.jpg

In a telephone interview, Dr. Barbieri said the report “needs to be taken seriously,” but he also believed the Valisure report is lacking information about testing under “real-world” conditions. He is calling for more information and more transparency about the data. What’s clear, Dr. Barbieri told this news organization, is that the findings about high benzene levels are not a manufacturing error. “It’s something to do with the molecule itself.”
 

Valisure’s Analyses

Valisure performed an initial analysis, using a method called gas chromatography-mass spectrometry, which is the FDA-preferred method for detecting benzene, Mr. Light said. It tested 175 acne products, 99 containing BP and 76 with other ingredients, such as salicylic acid. All the products without BP had no detectable benzene or values below 2 ppm, the FDA concentration limit for benzene.

Of the 99 BP products, 94 contained benzene without any elevated temperature incubation, according to Valisure. Using 50 °C (122 °F, the accepted pharmaceutical stability testing temperature) on 66 products, Valisure detected over 1500 ppm of benzene in two products, over 100 ppm in 17 products, and over 10 ppm in 42 products over an 18-day period.

The analysis confirmed, Valisure said in a press release and the petition, that a substantial amount of benzene can form in a BP product and leak outside the packaging into surrounding air.

The EHP paper, which includes authors from Valisure, reported that researchers took single lots of seven branded BP products, namely, Equate Beauty 2.5% BP cleansers, Neutrogena 10% BP cleanser, CVS Health 10% BP face wash, Walgreens 10% BP cream, Clean & Clear 10% cleanser, Equate Beauty 10% BP acne wash, and Proactiv 2.5% BP cleanser.

Using testing that involved gas chromatography-mass spectrometry, benzene was detected in all the BP products samples tested, and levels increased during incubation at body and shelf-life performance temperatures to more than 2 ppm. The authors concluded that the study “raises substantial concerns” about the safety of BP products currently on the market.
 

Methodology Debates

Two days after Valisure released its analysis on March 6, the USP reviewed the citizen’s petition filed by Valisure and called for more transparency around the testing methods.

“The petition referenced USP and indicated that modified USP methods and procedures were used in the study. The presence of unsafe levels of benzene should be taken seriously,” the statement said. The USP statement also noted that the Valisure analysis used modified USP methods and said that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

In its statement, USP took issue with a practice known as accelerated thermal degradation, which it said Valisure used. USP said the approach involves raising the storage temperature of a product to higher than the temperature indicated on the label for the purpose of simulating degradation over a longer period. While the approach may be acceptable, USP said, the temperatures chosen may not be what is expected to happen to the products.

In response, Mr. Light of Valisure referenced guidance issued in August, 2020, from the FDA, stating that the method it used in the BP analysis can be used to detect impurities in hand sanitizers, including benzene. (In 2021, Valisure detected high levels of benzene in some hand sanitizers and asked the FDA to take action.)
 

Company Response

Among the companies that took issue with the report was Reckitt, which makes Clearasil, which contains BP. In a statement, the company said, in part: “The products and their ingredients are stable over the storage conditions described on their packaging which represent all reasonable and foreseeable conditions.” It said the findings presented by Valisure reflect “unrealistic scenarios rather than real-world conditions.”

The Personal Care Products Council, a national trade association that represents cosmetic and personal care product manufacturers, also took issue with the findings and the approach used to evaluate the products.
 

FDA and the Citizen’s Petition

The FDA accepted the petition, Mr. Light said, and gave it a docket number. “We’ll hopefully hear more soon” because the FDA is required to respond to a citizen’s petition within 180 days, he said.

“We generally don’t comment on pending citizens’ petitions,” an FDA spokesperson said in an email. “When we respond, we will respond directly to the petitioner and post the response in the designated agency public docket.”
 

Valisure’s Patent Application

Mr. Light and others have applied for a patent on methods of producing shelf-stable formulations to prevent degradation of BP to benzene.

“We saw the problem long before we had any sort of application,” Mr. Light said. The issue has been “known for decades.”
 

Role of BP Products for Acne

In the midst of uncertainty, “the first discussion is, do we want to use it?” Dr. Barbieri said in the interview. Some patients may want to avoid it altogether, until more data are available, including more verification of the findings, while others may be comfortable accepting the potential risk, he said.

“Benzoyl peroxide is one of our foundational acne treatments,” Dr. Barbieri said. In the American Academy of Dermatology updated guidelines on acne, published in January, 2024, strong recommendations were made for BP products, as well as topical retinoids, topical antibiotics, and oral doxycycline.

“When you take away BP, there’s no substitute for it,” Dr. Barbieri said. And if patients don’t get improvement with topicals, oral medications might be needed, and “these all have their own risks.”
 

In the Interim

Until more information is available, Dr. Barbieri is advising patients not to store the products at high temperatures or for a long time. Don’t keep the products past their expiration date, and perhaps keep products for a shorter time, “something like a month,” he said.

Those living in a hot climate might consider storing the products in the refrigerator, he said.

“We need more data from Valisure, from other groups that confirm their findings, and we need to hear from the FDA,” Dr. Barbieri said. “There’s a lot of uncertainty right now. But it’s important not to overreact.”

Dr. Barbieri had no relevant disclosures.


 

A version of this article appeared on Medscape.com.

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

• Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
• In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
• Overall, 24% of participants had acne at the time of LARC insertion.
• Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

• During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
• Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
• Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

[embed:render:related:node:267688]

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

• Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
• In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
• Overall, 24% of participants had acne at the time of LARC insertion.
• Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

• During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
• Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
• Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

[embed:render:related:node:267688]

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

• Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
• In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
• Overall, 24% of participants had acne at the time of LARC insertion.
• Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

• During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
• Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
• Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

[embed:render:related:node:267688]

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.