New draft guidance from the World Professional Association for Transgender Health (WPATH) is raising serious concerns among professionals caring for people with gender dysphoria, prompting claims that WPATH is an organization “captured by activists.”

LemonTreeImages/Thinkstock

Experts in adolescent and child psychology, as well as pediatric health, have expressed dismay that the WPATH Standards of Care (SOC) 8 appear to miss some of the most urgent issues in the field of transgender medicine and are considered to express a radical and unreserved leaning towards “gender-affirmation.”

The WPATH SOC 8 document is available for view and comment until Dec. 16 until 11.59 PM EST, after which time revisions will be made and the final version published. 

Despite repeated attempts by this news organization to seek clarification on certain aspects of the guidance from members of the WPATH SOC 8 committee, requests were declined “until the guidance is finalized.”

According to the WPATH website, the SOC 8 aims to provide “clinical guidance for health professionals to assist transgender and gender diverse people with safe and effective pathways” to manage their gender dysphoria and potentially transition.

Such pathways may relate to primary care, gynecologic and urologic care, reproductive options, voice and communication therapy, mental health services, and hormonal or surgical treatments, among others.

WPATH adds that it was felt necessary to revise the existing SOC 7 (published in 2012) because of recent “globally unprecedented increase and visibility of transgender and gender-diverse people seeking support and gender-affirming medical treatment.”

Gender-affirming medical treatment means different things at different ages. In the case of kids with gender dysphoria who have not yet entered puberty associated with their birth sex, this might include prescribing so-called “puberty blockers” to delay natural puberty – gonadotrophin-releasing hormone analogs that are licensed for use in precocious puberty in children. Such agents have not been licensed for use in children with gender dysphoria, however, so any use for this purpose is off-label.

Following puberty blockade – or in cases where adolescents have already undergone natural puberty – the next step is to begin cross-sex hormones. So, for a female patient who wants to transition to male (FTM), that would be lifelong testosterone, and for a male who wants to be female (MTF), it involves lifelong estrogen. Again, use of such hormones in transgender individuals is entirely off-label.

Just last month, two of America’s leading experts on transgender medicine, both psychologists – including one who is transgender – told this news organization they were concerned that the quality of the evaluations of youth with gender dysphoria are being stifled by activists who are worried that open discussions will further stigmatize trans individuals.

They subsequently wrote an op-ed on the topic entitled, “The mental health establishment is failing trans kids,” which was finally published in the Washington Post on Nov. 24, after numerous other mainstream U.S. media outlets had rejected it.
 

New SOC 8 ‘is not evidence based,’ should not be new ‘gold standard’

One expert says the draft SOC 8 lacks balance and does not address certain issues, while paying undue attention to others that detract from real questions facing the field of transgender medicine, both in the United States and around the world.

Julia Mason, MD, is a pediatrician based in Gresham, Oregon, with a special interest in children and adolescents experiencing gender dysphoria. “The SOC 8 shows us that WPATH remains captured by activists,” she asserts. 

Dr. Mason questions the integrity of WPATH based on what she has read in the draft SOC 8.

“We need a serious organization to take a sober look at the evidence, and that is why we have established the Society for Evidence-Based Gender Medicine [SEGM],” she noted. “This is what we do – we are looking at all of the evidence.”

Dr. Mason is a clinical advisor to SEGM, an organization set-up to evaluate current interventions and evidence on gender dysphoria.

The pediatrician has particular concerns regarding the child and adolescent chapters in the draft SOC 8. The adolescent chapter states: “Guidelines are meant to provide a gold standard based on the available evidence at this moment of time.”

Dr. Mason disputes this assertion. “This document should not be the new gold standard going forward, primarily because it is not evidence based.”

In an interview, Dr. Mason explained that WPATH say they used the “Delphi consensus process” to determine their recommendations, but “this process is designed for use with a panel of experts when evidence is lacking. I would say they didn’t have a panel of experts. They largely had a panel of activists, with a few experts.”

There is no mention, for example, of England’s National Institute for Health and Care Excellence (NICE) evidence reviews on puberty blockers and cross-sex hormones from earlier this year. These reviews determined that no studies have compared cross-sex hormones or puberty blockers with a control group and all follow-up periods for cross-sex hormones were relatively short.

This disappoints Dr. Mason: “These are significant; they are important documents.”

And much of the evidence quoted comes from the well-known and often-quoted “Dutch-protocol” study of 2011, in which the children studied were much younger at the time of their gender dysphoria, compared with the many adolescents who make up the current surge in presentation at gender clinics worldwide, she adds.
 

Rapid-onset GD: adolescents presenting late with little history

Dr. Mason also stresses that the SOC 8 does not address the most urgent issues in transgender medicine today, mainly because it does not address rapid-onset gender dysphoria (ROGD): “This is the dilemma of the 21st century; it’s new.”

ROGD – a term first coined in 2018 by researcher Lisa Littman, MD, MPH, now president of the Institute for Comprehensive Gender Dysphoria Research (ICGDR) – refers to the phenomena of adolescents expressing a desire to transition from their birth sex after little or no apparent previous indication.

However, the SOC 8 does make reference to aspects of adolescent development that might impact their decision-making processes around gender identity during teen years. The chapter on adolescents reads: “... adolescence is also often associated with increased risk-taking behaviors. Along with these notable changes ... individuation from parents ... [there is] often a heightened focus on peer relationships, which can be both positive and detrimental.” 

The guidance goes on to point out that “it is critical to understand how all of these aspects of development may impact the decision-making for a given young person within their specific cultural context.” 
 

Desistance and detransitioning not adequately addressed

Dr. Mason also says there is little mention “about detransitioning in this SOC [8], and ‘gender dysphoria’ and ‘trans’ are terms that are not defined.” 

Likewise, there is no mention of desistance, she highlights, which is when individuals naturally resolve their dysphoria around their birth sex as they grow older.

The most recent published data seen by this news organization relates to a study from March 2021 that showed nearly 88% of boys who struggled with gender identity in childhood (approximate mean age 8 years and follow-up at approximate mean age 20 years) desisted. It reads: “Of the 139 participants, 17 (12.2%) were classified as ‘persisters’ and the remaining 122 (87.8%) were classified as desisters.”

“Most children with gender dysphoria will desist and lose their concept of themselves as being the opposite gender,” Dr. Mason explains. “This is the safest path for a child – desistance.”

“Transition can turn a healthy young person into a lifelong medical patient and has significant health risks,” she emphasizes, stressing that transition has not been shown to decrease the probability of suicide, or attempts at suicide, despite myriad claims saying otherwise. 

“Before we were routinely transitioning kids at school, the vast majority of children grew out of their gender dysphoria. This history is not recognized at all in these SOC [8],” she maintains.

Ken Zucker, PhD, CPsych, an author of the study of desistance in boys, says the terms desistence and persistence of gender dysphoria have caused some consternation in certain circles.

An editor of the Archives of Sexual Behavior and professor in the department of psychiatry, University of Toronto, Dr. Zucker has published widely on the topic.

He told this news organization: “The terms persistence and desistance have become verboten among the WPATH cognoscenti. Perhaps the contributors to SOC 8 have come up with alternative descriptors.”  

“The term ‘desistance’ is particularly annoying to some of the gender-affirming clinicians, because they don’t believe that desistance is bona fide,” Dr. Zucker points out.

“The desistance resisters are like anti-vaxxers – nothing one can provide as evidence for the efficacy of vaccines is sufficient. There will always be a new objection.” 

Other mental health issues, in particular ADHD and autism

It is also widely acknowledged that there is a higher rate of neurodevelopmental and psychiatric diagnoses in individuals with gender dysphoria. For example, one 2020 study found that transgender people were three to six times as likely to be autistic as cisgender people (those whose gender is aligned with their birth sex). 

Statement one in the chapter on adolescents in draft WPATH SOC 8 does give a nod to this, pointing out that health professionals working with gender diverse adolescents “should receive training and develop expertise in autism spectrum disorders and other neurodiversity conditions.”

It also notes that in some cases “a more extended assessment process may be useful, such as for youth with more complex presentations (e.g., complicated mental health histories, co-occurring autism spectrum characteristics in particular) and an absence of experienced childhood gender incongruence.”

However, Dr. Mason stresses that underlying mental health issues are central to addressing how to manage a significant number of these patients.

“If a young person has ADHD or autism, they are not ready to make decisions about the rest of their life at age 18. Even a neurotypical young person is still developing their frontal cortex in their early 20s, and it takes longer for those with ADHD or on the autism spectrum.”

She firmly believes that the guidance does not give sufficient consideration to comorbidities in people over the age of 18.

According to their [SOC 8] guidelines, “once someone is 18 they are ready for anything,” says Dr. Mason.  

Offering some explanation for the increased prevalence of ADHD and autism in those with gender dysphoria, Dr. Mason notes that children can have “hyperfocus” and those with autism will fixate on a particular area of interest. “If a child is unhappy in their life, and this can be more likely if someone is neuro-atypical, then it is likely that the individual might go online and find this one solution [for example, a transgender identity] that seems to fix everything.” 

Perceptions of femininity and masculinity can also be extra challenging for a child with autism, Dr. Mason says. “It is relatively easy for an autistic girl to feel like she should be a boy because the rules of femininity are composed of nonverbal, subtle behaviors that can be difficult to pick up on,” she points out. “An autistic child who isn’t particularly good at nonverbal communication might not pick up on these and thus feel they are not very ‘female.’” 

“There’s a whole lot of grass-is-greener-type thinking. Girls think boys have an easier life, and boys think girls have an easier life. I know some detransitioners who have spoken eloquently about realizing their mistake on this,” she adds.

Other parts of the SOC 8 that Dr. Mason disagrees with include the recommendation in the adolescent chapter that 14-year-olds are mature enough to start cross-sex hormones, that is, giving testosterone to a female who wants to transition to male or estrogen to a male who wishes to transition to female. “I think that’s far too young,” she asserts.

And she points out that the document states 17-year-olds are ready for genital reassignment surgery. Again, she believes this is far too young.

“Also, the SOC 8 document does not clarify who is appropriate for surgery. Whenever surgery is discussed, it becomes very vague,” she said. 

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

New draft guidance from the World Professional Association for Transgender Health (WPATH) is raising serious concerns among professionals caring for people with gender dysphoria, prompting claims that WPATH is an organization “captured by activists.”

LemonTreeImages/Thinkstock

Experts in adolescent and child psychology, as well as pediatric health, have expressed dismay that the WPATH Standards of Care (SOC) 8 appear to miss some of the most urgent issues in the field of transgender medicine and are considered to express a radical and unreserved leaning towards “gender-affirmation.”

The WPATH SOC 8 document is available for view and comment until Dec. 16 until 11.59 PM EST, after which time revisions will be made and the final version published. 

Despite repeated attempts by this news organization to seek clarification on certain aspects of the guidance from members of the WPATH SOC 8 committee, requests were declined “until the guidance is finalized.”

According to the WPATH website, the SOC 8 aims to provide “clinical guidance for health professionals to assist transgender and gender diverse people with safe and effective pathways” to manage their gender dysphoria and potentially transition.

Such pathways may relate to primary care, gynecologic and urologic care, reproductive options, voice and communication therapy, mental health services, and hormonal or surgical treatments, among others.

WPATH adds that it was felt necessary to revise the existing SOC 7 (published in 2012) because of recent “globally unprecedented increase and visibility of transgender and gender-diverse people seeking support and gender-affirming medical treatment.”

Gender-affirming medical treatment means different things at different ages. In the case of kids with gender dysphoria who have not yet entered puberty associated with their birth sex, this might include prescribing so-called “puberty blockers” to delay natural puberty – gonadotrophin-releasing hormone analogs that are licensed for use in precocious puberty in children. Such agents have not been licensed for use in children with gender dysphoria, however, so any use for this purpose is off-label.

Following puberty blockade – or in cases where adolescents have already undergone natural puberty – the next step is to begin cross-sex hormones. So, for a female patient who wants to transition to male (FTM), that would be lifelong testosterone, and for a male who wants to be female (MTF), it involves lifelong estrogen. Again, use of such hormones in transgender individuals is entirely off-label.

Just last month, two of America’s leading experts on transgender medicine, both psychologists – including one who is transgender – told this news organization they were concerned that the quality of the evaluations of youth with gender dysphoria are being stifled by activists who are worried that open discussions will further stigmatize trans individuals.

They subsequently wrote an op-ed on the topic entitled, “The mental health establishment is failing trans kids,” which was finally published in the Washington Post on Nov. 24, after numerous other mainstream U.S. media outlets had rejected it.
 

New SOC 8 ‘is not evidence based,’ should not be new ‘gold standard’

One expert says the draft SOC 8 lacks balance and does not address certain issues, while paying undue attention to others that detract from real questions facing the field of transgender medicine, both in the United States and around the world.

Julia Mason, MD, is a pediatrician based in Gresham, Oregon, with a special interest in children and adolescents experiencing gender dysphoria. “The SOC 8 shows us that WPATH remains captured by activists,” she asserts. 

Dr. Mason questions the integrity of WPATH based on what she has read in the draft SOC 8.

“We need a serious organization to take a sober look at the evidence, and that is why we have established the Society for Evidence-Based Gender Medicine [SEGM],” she noted. “This is what we do – we are looking at all of the evidence.”

Dr. Mason is a clinical advisor to SEGM, an organization set-up to evaluate current interventions and evidence on gender dysphoria.

The pediatrician has particular concerns regarding the child and adolescent chapters in the draft SOC 8. The adolescent chapter states: “Guidelines are meant to provide a gold standard based on the available evidence at this moment of time.”

Dr. Mason disputes this assertion. “This document should not be the new gold standard going forward, primarily because it is not evidence based.”

In an interview, Dr. Mason explained that WPATH say they used the “Delphi consensus process” to determine their recommendations, but “this process is designed for use with a panel of experts when evidence is lacking. I would say they didn’t have a panel of experts. They largely had a panel of activists, with a few experts.”

There is no mention, for example, of England’s National Institute for Health and Care Excellence (NICE) evidence reviews on puberty blockers and cross-sex hormones from earlier this year. These reviews determined that no studies have compared cross-sex hormones or puberty blockers with a control group and all follow-up periods for cross-sex hormones were relatively short.

This disappoints Dr. Mason: “These are significant; they are important documents.”

And much of the evidence quoted comes from the well-known and often-quoted “Dutch-protocol” study of 2011, in which the children studied were much younger at the time of their gender dysphoria, compared with the many adolescents who make up the current surge in presentation at gender clinics worldwide, she adds.
 

Rapid-onset GD: adolescents presenting late with little history

Dr. Mason also stresses that the SOC 8 does not address the most urgent issues in transgender medicine today, mainly because it does not address rapid-onset gender dysphoria (ROGD): “This is the dilemma of the 21st century; it’s new.”

ROGD – a term first coined in 2018 by researcher Lisa Littman, MD, MPH, now president of the Institute for Comprehensive Gender Dysphoria Research (ICGDR) – refers to the phenomena of adolescents expressing a desire to transition from their birth sex after little or no apparent previous indication.

However, the SOC 8 does make reference to aspects of adolescent development that might impact their decision-making processes around gender identity during teen years. The chapter on adolescents reads: “... adolescence is also often associated with increased risk-taking behaviors. Along with these notable changes ... individuation from parents ... [there is] often a heightened focus on peer relationships, which can be both positive and detrimental.” 

The guidance goes on to point out that “it is critical to understand how all of these aspects of development may impact the decision-making for a given young person within their specific cultural context.” 
 

Desistance and detransitioning not adequately addressed

Dr. Mason also says there is little mention “about detransitioning in this SOC [8], and ‘gender dysphoria’ and ‘trans’ are terms that are not defined.” 

Likewise, there is no mention of desistance, she highlights, which is when individuals naturally resolve their dysphoria around their birth sex as they grow older.

The most recent published data seen by this news organization relates to a study from March 2021 that showed nearly 88% of boys who struggled with gender identity in childhood (approximate mean age 8 years and follow-up at approximate mean age 20 years) desisted. It reads: “Of the 139 participants, 17 (12.2%) were classified as ‘persisters’ and the remaining 122 (87.8%) were classified as desisters.”

“Most children with gender dysphoria will desist and lose their concept of themselves as being the opposite gender,” Dr. Mason explains. “This is the safest path for a child – desistance.”

“Transition can turn a healthy young person into a lifelong medical patient and has significant health risks,” she emphasizes, stressing that transition has not been shown to decrease the probability of suicide, or attempts at suicide, despite myriad claims saying otherwise. 

“Before we were routinely transitioning kids at school, the vast majority of children grew out of their gender dysphoria. This history is not recognized at all in these SOC [8],” she maintains.

Ken Zucker, PhD, CPsych, an author of the study of desistance in boys, says the terms desistence and persistence of gender dysphoria have caused some consternation in certain circles.

An editor of the Archives of Sexual Behavior and professor in the department of psychiatry, University of Toronto, Dr. Zucker has published widely on the topic.

He told this news organization: “The terms persistence and desistance have become verboten among the WPATH cognoscenti. Perhaps the contributors to SOC 8 have come up with alternative descriptors.”  

“The term ‘desistance’ is particularly annoying to some of the gender-affirming clinicians, because they don’t believe that desistance is bona fide,” Dr. Zucker points out.

“The desistance resisters are like anti-vaxxers – nothing one can provide as evidence for the efficacy of vaccines is sufficient. There will always be a new objection.” 

Other mental health issues, in particular ADHD and autism

It is also widely acknowledged that there is a higher rate of neurodevelopmental and psychiatric diagnoses in individuals with gender dysphoria. For example, one 2020 study found that transgender people were three to six times as likely to be autistic as cisgender people (those whose gender is aligned with their birth sex). 

Statement one in the chapter on adolescents in draft WPATH SOC 8 does give a nod to this, pointing out that health professionals working with gender diverse adolescents “should receive training and develop expertise in autism spectrum disorders and other neurodiversity conditions.”

It also notes that in some cases “a more extended assessment process may be useful, such as for youth with more complex presentations (e.g., complicated mental health histories, co-occurring autism spectrum characteristics in particular) and an absence of experienced childhood gender incongruence.”

However, Dr. Mason stresses that underlying mental health issues are central to addressing how to manage a significant number of these patients.

“If a young person has ADHD or autism, they are not ready to make decisions about the rest of their life at age 18. Even a neurotypical young person is still developing their frontal cortex in their early 20s, and it takes longer for those with ADHD or on the autism spectrum.”

She firmly believes that the guidance does not give sufficient consideration to comorbidities in people over the age of 18.

According to their [SOC 8] guidelines, “once someone is 18 they are ready for anything,” says Dr. Mason.  

Offering some explanation for the increased prevalence of ADHD and autism in those with gender dysphoria, Dr. Mason notes that children can have “hyperfocus” and those with autism will fixate on a particular area of interest. “If a child is unhappy in their life, and this can be more likely if someone is neuro-atypical, then it is likely that the individual might go online and find this one solution [for example, a transgender identity] that seems to fix everything.” 

Perceptions of femininity and masculinity can also be extra challenging for a child with autism, Dr. Mason says. “It is relatively easy for an autistic girl to feel like she should be a boy because the rules of femininity are composed of nonverbal, subtle behaviors that can be difficult to pick up on,” she points out. “An autistic child who isn’t particularly good at nonverbal communication might not pick up on these and thus feel they are not very ‘female.’” 

“There’s a whole lot of grass-is-greener-type thinking. Girls think boys have an easier life, and boys think girls have an easier life. I know some detransitioners who have spoken eloquently about realizing their mistake on this,” she adds.

Other parts of the SOC 8 that Dr. Mason disagrees with include the recommendation in the adolescent chapter that 14-year-olds are mature enough to start cross-sex hormones, that is, giving testosterone to a female who wants to transition to male or estrogen to a male who wishes to transition to female. “I think that’s far too young,” she asserts.

And she points out that the document states 17-year-olds are ready for genital reassignment surgery. Again, she believes this is far too young.

“Also, the SOC 8 document does not clarify who is appropriate for surgery. Whenever surgery is discussed, it becomes very vague,” she said. 

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

New draft guidance from the World Professional Association for Transgender Health (WPATH) is raising serious concerns among professionals caring for people with gender dysphoria, prompting claims that WPATH is an organization “captured by activists.”

LemonTreeImages/Thinkstock

Experts in adolescent and child psychology, as well as pediatric health, have expressed dismay that the WPATH Standards of Care (SOC) 8 appear to miss some of the most urgent issues in the field of transgender medicine and are considered to express a radical and unreserved leaning towards “gender-affirmation.”

The WPATH SOC 8 document is available for view and comment until Dec. 16 until 11.59 PM EST, after which time revisions will be made and the final version published. 

Despite repeated attempts by this news organization to seek clarification on certain aspects of the guidance from members of the WPATH SOC 8 committee, requests were declined “until the guidance is finalized.”

According to the WPATH website, the SOC 8 aims to provide “clinical guidance for health professionals to assist transgender and gender diverse people with safe and effective pathways” to manage their gender dysphoria and potentially transition.

Such pathways may relate to primary care, gynecologic and urologic care, reproductive options, voice and communication therapy, mental health services, and hormonal or surgical treatments, among others.

WPATH adds that it was felt necessary to revise the existing SOC 7 (published in 2012) because of recent “globally unprecedented increase and visibility of transgender and gender-diverse people seeking support and gender-affirming medical treatment.”

Gender-affirming medical treatment means different things at different ages. In the case of kids with gender dysphoria who have not yet entered puberty associated with their birth sex, this might include prescribing so-called “puberty blockers” to delay natural puberty – gonadotrophin-releasing hormone analogs that are licensed for use in precocious puberty in children. Such agents have not been licensed for use in children with gender dysphoria, however, so any use for this purpose is off-label.

Following puberty blockade – or in cases where adolescents have already undergone natural puberty – the next step is to begin cross-sex hormones. So, for a female patient who wants to transition to male (FTM), that would be lifelong testosterone, and for a male who wants to be female (MTF), it involves lifelong estrogen. Again, use of such hormones in transgender individuals is entirely off-label.

Just last month, two of America’s leading experts on transgender medicine, both psychologists – including one who is transgender – told this news organization they were concerned that the quality of the evaluations of youth with gender dysphoria are being stifled by activists who are worried that open discussions will further stigmatize trans individuals.

They subsequently wrote an op-ed on the topic entitled, “The mental health establishment is failing trans kids,” which was finally published in the Washington Post on Nov. 24, after numerous other mainstream U.S. media outlets had rejected it.
 

New SOC 8 ‘is not evidence based,’ should not be new ‘gold standard’

One expert says the draft SOC 8 lacks balance and does not address certain issues, while paying undue attention to others that detract from real questions facing the field of transgender medicine, both in the United States and around the world.

Julia Mason, MD, is a pediatrician based in Gresham, Oregon, with a special interest in children and adolescents experiencing gender dysphoria. “The SOC 8 shows us that WPATH remains captured by activists,” she asserts. 

Dr. Mason questions the integrity of WPATH based on what she has read in the draft SOC 8.

“We need a serious organization to take a sober look at the evidence, and that is why we have established the Society for Evidence-Based Gender Medicine [SEGM],” she noted. “This is what we do – we are looking at all of the evidence.”

Dr. Mason is a clinical advisor to SEGM, an organization set-up to evaluate current interventions and evidence on gender dysphoria.

The pediatrician has particular concerns regarding the child and adolescent chapters in the draft SOC 8. The adolescent chapter states: “Guidelines are meant to provide a gold standard based on the available evidence at this moment of time.”

Dr. Mason disputes this assertion. “This document should not be the new gold standard going forward, primarily because it is not evidence based.”

In an interview, Dr. Mason explained that WPATH say they used the “Delphi consensus process” to determine their recommendations, but “this process is designed for use with a panel of experts when evidence is lacking. I would say they didn’t have a panel of experts. They largely had a panel of activists, with a few experts.”

There is no mention, for example, of England’s National Institute for Health and Care Excellence (NICE) evidence reviews on puberty blockers and cross-sex hormones from earlier this year. These reviews determined that no studies have compared cross-sex hormones or puberty blockers with a control group and all follow-up periods for cross-sex hormones were relatively short.

This disappoints Dr. Mason: “These are significant; they are important documents.”

And much of the evidence quoted comes from the well-known and often-quoted “Dutch-protocol” study of 2011, in which the children studied were much younger at the time of their gender dysphoria, compared with the many adolescents who make up the current surge in presentation at gender clinics worldwide, she adds.
 

Rapid-onset GD: adolescents presenting late with little history

Dr. Mason also stresses that the SOC 8 does not address the most urgent issues in transgender medicine today, mainly because it does not address rapid-onset gender dysphoria (ROGD): “This is the dilemma of the 21st century; it’s new.”

ROGD – a term first coined in 2018 by researcher Lisa Littman, MD, MPH, now president of the Institute for Comprehensive Gender Dysphoria Research (ICGDR) – refers to the phenomena of adolescents expressing a desire to transition from their birth sex after little or no apparent previous indication.

However, the SOC 8 does make reference to aspects of adolescent development that might impact their decision-making processes around gender identity during teen years. The chapter on adolescents reads: “... adolescence is also often associated with increased risk-taking behaviors. Along with these notable changes ... individuation from parents ... [there is] often a heightened focus on peer relationships, which can be both positive and detrimental.” 

The guidance goes on to point out that “it is critical to understand how all of these aspects of development may impact the decision-making for a given young person within their specific cultural context.” 
 

Desistance and detransitioning not adequately addressed

Dr. Mason also says there is little mention “about detransitioning in this SOC [8], and ‘gender dysphoria’ and ‘trans’ are terms that are not defined.” 

Likewise, there is no mention of desistance, she highlights, which is when individuals naturally resolve their dysphoria around their birth sex as they grow older.

The most recent published data seen by this news organization relates to a study from March 2021 that showed nearly 88% of boys who struggled with gender identity in childhood (approximate mean age 8 years and follow-up at approximate mean age 20 years) desisted. It reads: “Of the 139 participants, 17 (12.2%) were classified as ‘persisters’ and the remaining 122 (87.8%) were classified as desisters.”

“Most children with gender dysphoria will desist and lose their concept of themselves as being the opposite gender,” Dr. Mason explains. “This is the safest path for a child – desistance.”

“Transition can turn a healthy young person into a lifelong medical patient and has significant health risks,” she emphasizes, stressing that transition has not been shown to decrease the probability of suicide, or attempts at suicide, despite myriad claims saying otherwise. 

“Before we were routinely transitioning kids at school, the vast majority of children grew out of their gender dysphoria. This history is not recognized at all in these SOC [8],” she maintains.

Ken Zucker, PhD, CPsych, an author of the study of desistance in boys, says the terms desistence and persistence of gender dysphoria have caused some consternation in certain circles.

An editor of the Archives of Sexual Behavior and professor in the department of psychiatry, University of Toronto, Dr. Zucker has published widely on the topic.

He told this news organization: “The terms persistence and desistance have become verboten among the WPATH cognoscenti. Perhaps the contributors to SOC 8 have come up with alternative descriptors.”  

“The term ‘desistance’ is particularly annoying to some of the gender-affirming clinicians, because they don’t believe that desistance is bona fide,” Dr. Zucker points out.

“The desistance resisters are like anti-vaxxers – nothing one can provide as evidence for the efficacy of vaccines is sufficient. There will always be a new objection.” 

Other mental health issues, in particular ADHD and autism

It is also widely acknowledged that there is a higher rate of neurodevelopmental and psychiatric diagnoses in individuals with gender dysphoria. For example, one 2020 study found that transgender people were three to six times as likely to be autistic as cisgender people (those whose gender is aligned with their birth sex). 

Statement one in the chapter on adolescents in draft WPATH SOC 8 does give a nod to this, pointing out that health professionals working with gender diverse adolescents “should receive training and develop expertise in autism spectrum disorders and other neurodiversity conditions.”

It also notes that in some cases “a more extended assessment process may be useful, such as for youth with more complex presentations (e.g., complicated mental health histories, co-occurring autism spectrum characteristics in particular) and an absence of experienced childhood gender incongruence.”

However, Dr. Mason stresses that underlying mental health issues are central to addressing how to manage a significant number of these patients.

“If a young person has ADHD or autism, they are not ready to make decisions about the rest of their life at age 18. Even a neurotypical young person is still developing their frontal cortex in their early 20s, and it takes longer for those with ADHD or on the autism spectrum.”

She firmly believes that the guidance does not give sufficient consideration to comorbidities in people over the age of 18.

According to their [SOC 8] guidelines, “once someone is 18 they are ready for anything,” says Dr. Mason.  

Offering some explanation for the increased prevalence of ADHD and autism in those with gender dysphoria, Dr. Mason notes that children can have “hyperfocus” and those with autism will fixate on a particular area of interest. “If a child is unhappy in their life, and this can be more likely if someone is neuro-atypical, then it is likely that the individual might go online and find this one solution [for example, a transgender identity] that seems to fix everything.” 

Perceptions of femininity and masculinity can also be extra challenging for a child with autism, Dr. Mason says. “It is relatively easy for an autistic girl to feel like she should be a boy because the rules of femininity are composed of nonverbal, subtle behaviors that can be difficult to pick up on,” she points out. “An autistic child who isn’t particularly good at nonverbal communication might not pick up on these and thus feel they are not very ‘female.’” 

“There’s a whole lot of grass-is-greener-type thinking. Girls think boys have an easier life, and boys think girls have an easier life. I know some detransitioners who have spoken eloquently about realizing their mistake on this,” she adds.

Other parts of the SOC 8 that Dr. Mason disagrees with include the recommendation in the adolescent chapter that 14-year-olds are mature enough to start cross-sex hormones, that is, giving testosterone to a female who wants to transition to male or estrogen to a male who wishes to transition to female. “I think that’s far too young,” she asserts.

And she points out that the document states 17-year-olds are ready for genital reassignment surgery. Again, she believes this is far too young.

“Also, the SOC 8 document does not clarify who is appropriate for surgery. Whenever surgery is discussed, it becomes very vague,” she said. 

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

A young woman is having her lip swabbed with an unknown substance, smiling, on the TikTok video. Seconds later, another young woman, wearing gloves, pushes a hyaluron pen against the first woman’s lips, who, in the next cut, is smiling, happy. “My first syringe down and already 1,000x more confident,” the caption reads.

That video is one of thousands showing hyaluron pen use on TikTok. The pens are sold online and are unapproved – which led to a Food and Drug Administration warning in October 2021 that use could cause bleeding, infection, blood vessel occlusion that could result in blindness or stroke, allergic reactions, and other injuries.

The warning has not stopped many TikTokkers, who also use the medium to promote all sorts of skin and aesthetic products and procedures, a large number unproven, unapproved, or ill advised. As TikTok has become one of the most widely used social media platforms, millions of mostly teenagers regularly log on for skin care advice, which, more often than not, comes from “skinfluencers,” aestheticians, and other laypeople, not board-certified dermatologists.

The suggested “hacks” can be harmless or ineffective, but they also can be misleading, fraudulent, or even dangerous.
 

Skinfluencers take the lead

TikTok has a reported 1 billion monthly users. Two-thirds are aged 10-29 years, according to data reported in February 2021 in the Journal of the American Academy of Dermatology by David X. Zheng, BA, and colleagues at Case Western Reserve University, Cleveland, and the department of dermatology, Johns Hopkins University, Baltimore.

Visitors consume information in video bits that run from 15 seconds to up to 3 minutes and can follow their favorite TikTokkers, browse for people or hashtags with a search function, or click on content recommended by the platform, which uses algorithms based on the user’s viewing habits to determine what might be of interest.

Some of the biggest “skinfluencers” have millions of followers: Hyram Yarbro, (@skincarebyhyram) for instance, has 6.6 million followers and his own line of skin care products at Sephora. Mr. Yarbro is seen as a no-nonsense debunker of skin care myths, as is British influencer James Welsh, who has 124,000 followers.

“The reason why people trust your average influencer person who’s not a doctor is because they’re relatable,” said Muneeb Shah, MD, a dermatology resident at Atlantic Dermatology in Wilmington, N.C. – known to his 11.4 million TikTok followers as @dermdoctor.

To Sandra Lee, MD, the popularity of nonprofessionals is easy to explain. “You have to think about the fact that a lot of people can’t see dermatologists – they don’t have the money, they don’t have the time to travel there, they don’t have health insurance, or they’re scared of doctors, so they’re willing to try to find an answer, and one of the easiest ways, one of the more entertaining ways to get information, is on social media.”

Dr. Lee is in private practice in Upland, Calif., but is better known as “Dr. Pimple Popper,” through her television show of the same name and her social media accounts, including on TikTok, where she has 14.4 million followers after having started in 2020.

“We’re all looking for that no-down-time, no-expense, no-lines, no-wrinkles, stay-young-forever magic bullet,” said Dr. Lee.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, agreed that people are looking for a quick fix. They don’t want to wait 12 weeks for an acne medication or 16 weeks for a biologic to work. “They want something simple, easy, do-it-yourself,” and “natural,” he said.

Laypeople are still the dominant producers – and have the most views – of dermatology content.

Morgan Nguyen, BA, at Northwestern University, Chicago, and colleagues looked at hashtags for the top 10 dermatologic diagnoses and procedures and analyzed the content of the first 40 TikTok videos in each category. About half the videos were produced by an individual, and 39% by a health care provider, according to the study, published in the International Journal of Women’s Dermatology. About 40% of the videos were educational, focusing on skin care, procedures, and disease treatment.

Viewership was highest for videos by laypeople, followed by those produced by business or industry accounts. Those produced by health care providers received only 18% of the views.

The most popular videos were about dermatologic diagnoses, with 2.5 billion views, followed by dermatologic procedures, with 708 million views.

Ms. Nguyen noted in the study that the most liked and most viewed posts were related to #skincare but that board-certified dermatologists produced only 2.5% of the #skincare videos.


 

Dermatologists take to TikTok

Some dermatologists have started their own TikTok accounts, seeking both to counteract misinformation and provide education.

Dr. Shah has become one of the top influencers on the platform. In a year-end wrap, TikTok put Dr. Shah at No. 7 on its top creators list for 2021.

MDedge

Doris Day, MD, who goes by @drdorisday on TikTok, agreed with Dr. Lee. “There are so many creative ways you can convey information with it that’s different than what you have on Instagram,” said Dr. Day, who is in private practice in New York. And, she added, “it does really lend itself to getting points out super-fast.”

Dermatologists on TikTok also said they like the “duets” and the “stitch” features, which allow users to add on to an existing video, essentially chiming in or responding to what might have already been posted, in a side-by-side format.

Dr. Shah said he often duets videos that have questionable content. “It allows me to directly respond to people. A lot of times, if something is going really viral and it’s not accurate, you’ll have a response from me or one of the other doctors” within hours or days.

Dr. Shah’s duets are labeled with “DermDoctor Reacts” or “DermDoctor Explains.” In one duet, with more than 2.8 million views, the upper half of the video is someone squeezing a blackhead, while Dr. Shah, in the bottom half, in green scrubs, opines over some hip-hop music: “This is just a blackhead. But once it gets to this point, they do need to be extracted because topical treatments won’t help.”

TikTok trends gone bad

And some people are being hurt by emulating what they see on TikTok.

Dr. Friedman had a patient with extreme irritant contact dermatitis, “almost like chemical burns to her underarms,” he said. He determined that she saw a video “hack” that recommended using baking soda to stop hyperhidrosis. The patient used so much that it burned her skin.

In 2020, do-it-yourself freckles – with henna or sewing needles impregnated with ink – went viral. Tilly Whitfeld, a 21-year-old reality TV star on Australia’s Big Brother show, told the New York Times that she tried it at home after seeing a TikTok video. She ordered brown tattoo ink online and later found out that it was contaminated with lead, according to the Times. Ms. Whitfeld developed an infection and temporary vision loss and has permanent scarring.

She has since put out a cautionary TikTok video that’s been viewed some 300,000 times.

TikTokkers have also flocked to the idea of using sunscreen to “contour” the face. Selected areas are left without sunscreen to burn or tan. In a duet, a plastic surgeon shakes his head as a young woman explains that “it works.”

Scalp-popping – in which the hair is yanked so hard that it pulls the galea off the skull – has been mostly shut down by TikTok. A search of “scalp popping” brings up the message: “Learn how to recognize harmful challenges and hoaxes.” At-home mole and skin tag removal, pimple-popping, and supposed acne cures such as drinking chlorophyll are all avidly documented and shared on TikTok.

Dr. Shah had a back-and-forth video dialog with someone who had stubbed a toe and then drilled a hole into the nail to drain the hematoma. In a reaction video, Dr. Shah said it was likely to turn into an infection. When it did, the man revealed the infection in a video where he tagged Dr. Shah and later posted a video at the podiatrist’s office having his nail removed, again tagging Dr. Shah.

“I think that pretty much no procedure for skin is good to do at home,” said Dr. Shah, who repeatedly admonishes against mole removal by a nonphysician. He tells followers that “it’s extremely dangerous – not only is it going to cause scarring, but you are potentially discarding a cancerous lesion.”

Unfortunately, most will not follow the advice, said Dr. Shah. That’s especially true of pimple-popping. Aiming for the least harm, he suggests in some TikTok videos that poppers keep the area clean, wear gloves, and consult a physician to get an antibiotic prescription. “You might as well at least guide them in the right direction,” he added.

Dr. Lee believes that lack of access to physicians, insurance, or money may play into how TikTok trends evolve. “Probably those people who injected their lips with this air gun thing, maybe they didn’t have the money necessarily to get filler,” she said.

Also, she noted, while TikTok may try to police its content, creators are incentivized to be outrageous. “The more inflammatory your post is, the more engagement you get.”

Dr. Shah thinks TikTok is self-correcting. “If you’re not being ethical or contradicting yourself, putting out information that’s not accurate, people are going to catch on very quickly,” he said. “The only value, the only currency you have on social media is the trust that you build with people that follow you.”
 

What it takes to be a TikTokker

For dermatologists, conveying their credentials and experience is one way to build that currency. Dr. Lee advised fellow doctors on TikTok to “showcase your training and how many years it took to become a dermatologist.”

Plunging into TikTok is not for everyone, though. It’s time consuming, said Dr. Lee, who now devotes most of her nonclinical time to TikTok. She creates her own content, leaving others to manage her Instagram account.

Many of those in the medical field who have dived into TikTok are residents, like Dr. Shah. “They are attuned to it and understand it more,” said Dr. Lee. “It’s harder for a lot of us who are older, who really weren’t involved that much in social media at all. It’s very hard to jump in.” There’s a learning curve, and it takes hours to create a single video. “You have to enjoy it and it has to be a part of your life,” she said.

Dr. Shah started experimenting with TikTok at the beginning of the pandemic in 2020 and has never turned back. Fast-talking, curious, and with an infectious sense of fun, he shares tidbits about his personal life – putting his wife in some of his videos – and always seems upbeat.

He said that, as his following grew, users began to see him as an authority figure and started “tagging” him more often, seeking his opinion on other videos. Although still a resident, he believes he has specialized knowledge to share. “Even if you’re not the world’s leading expert in a particular topic, you’re still adding value for the person who doesn’t know much.”

Dr. Shah also occasionally does promotional TikToks, identified as sponsored content. He said he only works with companies that he believes have legitimate products. “You do have to monetize at some point,” he said, noting that many dermatologists, himself included, are trading clinic time for TikTok. “There’s no universe where they can do this for free.”

Product endorsements are likely more rewarding for influencers and other users like Dr. Shah than the remuneration from TikTok, the company. The platform pays user accounts $20 per 1 million views, Dr. Shah said. “Financially, it’s not a big winner for a practicing dermatologist, but the educational outreach is worthwhile.”

To be successful also means understanding what drives viewership.

Using “trending” sounds has “been shown to increase the likelihood of a video amassing millions of views” and may increase engagement with dermatologists’ TikTok videos, wrote Bina Kassamali, BA, and colleagues at the Brigham and Women’s Hospital in Boston and the Ponce Health Science University School of Medicine in Ponce, Puerto Rico, in a letter published in the Journal of the American Academy of Dermatology in July 2021.

Certain content is more likely to engage viewers. In their analysis of top trending dermatologic hashtags, acne-related content was viewed 6.7 billion times, followed by alopecia, with 1.1 billion views. Psoriasis content had 84 million views, putting it eighth on the list of topics.

Dermatologists are still cracking TikTok. They are accumulating more followers on TikTok than on Instagram but have greater engagement on Instagram reels, wrote Mindy D. Szeto, MS, and colleagues at the University of Colorado at Denver, Aurora, and Rocky Vista University in Parker, Colo., in the Journal of the American Academy of Dermatology in April 2021.

Dr. Lee and Dr. Shah had the highest engagement rate on TikTok, according to Ms. Szeto. The engagement rate is calculated as (likes + comments per post)/(total followers) x 100.

“TikTok may currently be the leading avenue for audience education by dermatologist influencers,” they wrote, urging dermatologists to use the platform to answer the call as more of the public “continues to turn to social media for medical advice.”

Dr. Day said she will keep trying to build her TikTok audience. She has just 239 followers, compared with her 44,500 on Instagram. “The more I do TikTok, the more I do any of these mediums, the better I get at it,” she said. “We just have to put a little time and effort into it and try to get more followers and just keep sharing the information.”

Dr. Friedman sees it as a positive that some dermatologists have taken to TikTok to dispel myths and put “good information out there in small bites.” But to be more effective, they need more followers.

“The truth is that 14-year-old is probably going to listen more to a Hyram than a dermatologist,” he said. “Maybe we need to work with these other individuals who know how to take these messages and convert them to a language that can be digested by a 14-year-old, by a 12-year-old, by a 23-year-old. We need to come to the table together and not fight.”

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

A young woman is having her lip swabbed with an unknown substance, smiling, on the TikTok video. Seconds later, another young woman, wearing gloves, pushes a hyaluron pen against the first woman’s lips, who, in the next cut, is smiling, happy. “My first syringe down and already 1,000x more confident,” the caption reads.

That video is one of thousands showing hyaluron pen use on TikTok. The pens are sold online and are unapproved – which led to a Food and Drug Administration warning in October 2021 that use could cause bleeding, infection, blood vessel occlusion that could result in blindness or stroke, allergic reactions, and other injuries.

The warning has not stopped many TikTokkers, who also use the medium to promote all sorts of skin and aesthetic products and procedures, a large number unproven, unapproved, or ill advised. As TikTok has become one of the most widely used social media platforms, millions of mostly teenagers regularly log on for skin care advice, which, more often than not, comes from “skinfluencers,” aestheticians, and other laypeople, not board-certified dermatologists.

The suggested “hacks” can be harmless or ineffective, but they also can be misleading, fraudulent, or even dangerous.
 

Skinfluencers take the lead

TikTok has a reported 1 billion monthly users. Two-thirds are aged 10-29 years, according to data reported in February 2021 in the Journal of the American Academy of Dermatology by David X. Zheng, BA, and colleagues at Case Western Reserve University, Cleveland, and the department of dermatology, Johns Hopkins University, Baltimore.

Visitors consume information in video bits that run from 15 seconds to up to 3 minutes and can follow their favorite TikTokkers, browse for people or hashtags with a search function, or click on content recommended by the platform, which uses algorithms based on the user’s viewing habits to determine what might be of interest.

Some of the biggest “skinfluencers” have millions of followers: Hyram Yarbro, (@skincarebyhyram) for instance, has 6.6 million followers and his own line of skin care products at Sephora. Mr. Yarbro is seen as a no-nonsense debunker of skin care myths, as is British influencer James Welsh, who has 124,000 followers.

“The reason why people trust your average influencer person who’s not a doctor is because they’re relatable,” said Muneeb Shah, MD, a dermatology resident at Atlantic Dermatology in Wilmington, N.C. – known to his 11.4 million TikTok followers as @dermdoctor.

To Sandra Lee, MD, the popularity of nonprofessionals is easy to explain. “You have to think about the fact that a lot of people can’t see dermatologists – they don’t have the money, they don’t have the time to travel there, they don’t have health insurance, or they’re scared of doctors, so they’re willing to try to find an answer, and one of the easiest ways, one of the more entertaining ways to get information, is on social media.”

Dr. Lee is in private practice in Upland, Calif., but is better known as “Dr. Pimple Popper,” through her television show of the same name and her social media accounts, including on TikTok, where she has 14.4 million followers after having started in 2020.

“We’re all looking for that no-down-time, no-expense, no-lines, no-wrinkles, stay-young-forever magic bullet,” said Dr. Lee.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, agreed that people are looking for a quick fix. They don’t want to wait 12 weeks for an acne medication or 16 weeks for a biologic to work. “They want something simple, easy, do-it-yourself,” and “natural,” he said.

Laypeople are still the dominant producers – and have the most views – of dermatology content.

Morgan Nguyen, BA, at Northwestern University, Chicago, and colleagues looked at hashtags for the top 10 dermatologic diagnoses and procedures and analyzed the content of the first 40 TikTok videos in each category. About half the videos were produced by an individual, and 39% by a health care provider, according to the study, published in the International Journal of Women’s Dermatology. About 40% of the videos were educational, focusing on skin care, procedures, and disease treatment.

Viewership was highest for videos by laypeople, followed by those produced by business or industry accounts. Those produced by health care providers received only 18% of the views.

The most popular videos were about dermatologic diagnoses, with 2.5 billion views, followed by dermatologic procedures, with 708 million views.

Ms. Nguyen noted in the study that the most liked and most viewed posts were related to #skincare but that board-certified dermatologists produced only 2.5% of the #skincare videos.


 

Dermatologists take to TikTok

Some dermatologists have started their own TikTok accounts, seeking both to counteract misinformation and provide education.

Dr. Shah has become one of the top influencers on the platform. In a year-end wrap, TikTok put Dr. Shah at No. 7 on its top creators list for 2021.

MDedge

Doris Day, MD, who goes by @drdorisday on TikTok, agreed with Dr. Lee. “There are so many creative ways you can convey information with it that’s different than what you have on Instagram,” said Dr. Day, who is in private practice in New York. And, she added, “it does really lend itself to getting points out super-fast.”

Dermatologists on TikTok also said they like the “duets” and the “stitch” features, which allow users to add on to an existing video, essentially chiming in or responding to what might have already been posted, in a side-by-side format.

Dr. Shah said he often duets videos that have questionable content. “It allows me to directly respond to people. A lot of times, if something is going really viral and it’s not accurate, you’ll have a response from me or one of the other doctors” within hours or days.

Dr. Shah’s duets are labeled with “DermDoctor Reacts” or “DermDoctor Explains.” In one duet, with more than 2.8 million views, the upper half of the video is someone squeezing a blackhead, while Dr. Shah, in the bottom half, in green scrubs, opines over some hip-hop music: “This is just a blackhead. But once it gets to this point, they do need to be extracted because topical treatments won’t help.”

TikTok trends gone bad

And some people are being hurt by emulating what they see on TikTok.

Dr. Friedman had a patient with extreme irritant contact dermatitis, “almost like chemical burns to her underarms,” he said. He determined that she saw a video “hack” that recommended using baking soda to stop hyperhidrosis. The patient used so much that it burned her skin.

In 2020, do-it-yourself freckles – with henna or sewing needles impregnated with ink – went viral. Tilly Whitfeld, a 21-year-old reality TV star on Australia’s Big Brother show, told the New York Times that she tried it at home after seeing a TikTok video. She ordered brown tattoo ink online and later found out that it was contaminated with lead, according to the Times. Ms. Whitfeld developed an infection and temporary vision loss and has permanent scarring.

She has since put out a cautionary TikTok video that’s been viewed some 300,000 times.

TikTokkers have also flocked to the idea of using sunscreen to “contour” the face. Selected areas are left without sunscreen to burn or tan. In a duet, a plastic surgeon shakes his head as a young woman explains that “it works.”

Scalp-popping – in which the hair is yanked so hard that it pulls the galea off the skull – has been mostly shut down by TikTok. A search of “scalp popping” brings up the message: “Learn how to recognize harmful challenges and hoaxes.” At-home mole and skin tag removal, pimple-popping, and supposed acne cures such as drinking chlorophyll are all avidly documented and shared on TikTok.

Dr. Shah had a back-and-forth video dialog with someone who had stubbed a toe and then drilled a hole into the nail to drain the hematoma. In a reaction video, Dr. Shah said it was likely to turn into an infection. When it did, the man revealed the infection in a video where he tagged Dr. Shah and later posted a video at the podiatrist’s office having his nail removed, again tagging Dr. Shah.

“I think that pretty much no procedure for skin is good to do at home,” said Dr. Shah, who repeatedly admonishes against mole removal by a nonphysician. He tells followers that “it’s extremely dangerous – not only is it going to cause scarring, but you are potentially discarding a cancerous lesion.”

Unfortunately, most will not follow the advice, said Dr. Shah. That’s especially true of pimple-popping. Aiming for the least harm, he suggests in some TikTok videos that poppers keep the area clean, wear gloves, and consult a physician to get an antibiotic prescription. “You might as well at least guide them in the right direction,” he added.

Dr. Lee believes that lack of access to physicians, insurance, or money may play into how TikTok trends evolve. “Probably those people who injected their lips with this air gun thing, maybe they didn’t have the money necessarily to get filler,” she said.

Also, she noted, while TikTok may try to police its content, creators are incentivized to be outrageous. “The more inflammatory your post is, the more engagement you get.”

Dr. Shah thinks TikTok is self-correcting. “If you’re not being ethical or contradicting yourself, putting out information that’s not accurate, people are going to catch on very quickly,” he said. “The only value, the only currency you have on social media is the trust that you build with people that follow you.”
 

What it takes to be a TikTokker

For dermatologists, conveying their credentials and experience is one way to build that currency. Dr. Lee advised fellow doctors on TikTok to “showcase your training and how many years it took to become a dermatologist.”

Plunging into TikTok is not for everyone, though. It’s time consuming, said Dr. Lee, who now devotes most of her nonclinical time to TikTok. She creates her own content, leaving others to manage her Instagram account.

Many of those in the medical field who have dived into TikTok are residents, like Dr. Shah. “They are attuned to it and understand it more,” said Dr. Lee. “It’s harder for a lot of us who are older, who really weren’t involved that much in social media at all. It’s very hard to jump in.” There’s a learning curve, and it takes hours to create a single video. “You have to enjoy it and it has to be a part of your life,” she said.

Dr. Shah started experimenting with TikTok at the beginning of the pandemic in 2020 and has never turned back. Fast-talking, curious, and with an infectious sense of fun, he shares tidbits about his personal life – putting his wife in some of his videos – and always seems upbeat.

He said that, as his following grew, users began to see him as an authority figure and started “tagging” him more often, seeking his opinion on other videos. Although still a resident, he believes he has specialized knowledge to share. “Even if you’re not the world’s leading expert in a particular topic, you’re still adding value for the person who doesn’t know much.”

Dr. Shah also occasionally does promotional TikToks, identified as sponsored content. He said he only works with companies that he believes have legitimate products. “You do have to monetize at some point,” he said, noting that many dermatologists, himself included, are trading clinic time for TikTok. “There’s no universe where they can do this for free.”

Product endorsements are likely more rewarding for influencers and other users like Dr. Shah than the remuneration from TikTok, the company. The platform pays user accounts $20 per 1 million views, Dr. Shah said. “Financially, it’s not a big winner for a practicing dermatologist, but the educational outreach is worthwhile.”

To be successful also means understanding what drives viewership.

Using “trending” sounds has “been shown to increase the likelihood of a video amassing millions of views” and may increase engagement with dermatologists’ TikTok videos, wrote Bina Kassamali, BA, and colleagues at the Brigham and Women’s Hospital in Boston and the Ponce Health Science University School of Medicine in Ponce, Puerto Rico, in a letter published in the Journal of the American Academy of Dermatology in July 2021.

Certain content is more likely to engage viewers. In their analysis of top trending dermatologic hashtags, acne-related content was viewed 6.7 billion times, followed by alopecia, with 1.1 billion views. Psoriasis content had 84 million views, putting it eighth on the list of topics.

Dermatologists are still cracking TikTok. They are accumulating more followers on TikTok than on Instagram but have greater engagement on Instagram reels, wrote Mindy D. Szeto, MS, and colleagues at the University of Colorado at Denver, Aurora, and Rocky Vista University in Parker, Colo., in the Journal of the American Academy of Dermatology in April 2021.

Dr. Lee and Dr. Shah had the highest engagement rate on TikTok, according to Ms. Szeto. The engagement rate is calculated as (likes + comments per post)/(total followers) x 100.

“TikTok may currently be the leading avenue for audience education by dermatologist influencers,” they wrote, urging dermatologists to use the platform to answer the call as more of the public “continues to turn to social media for medical advice.”

Dr. Day said she will keep trying to build her TikTok audience. She has just 239 followers, compared with her 44,500 on Instagram. “The more I do TikTok, the more I do any of these mediums, the better I get at it,” she said. “We just have to put a little time and effort into it and try to get more followers and just keep sharing the information.”

Dr. Friedman sees it as a positive that some dermatologists have taken to TikTok to dispel myths and put “good information out there in small bites.” But to be more effective, they need more followers.

“The truth is that 14-year-old is probably going to listen more to a Hyram than a dermatologist,” he said. “Maybe we need to work with these other individuals who know how to take these messages and convert them to a language that can be digested by a 14-year-old, by a 12-year-old, by a 23-year-old. We need to come to the table together and not fight.”

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

A young woman is having her lip swabbed with an unknown substance, smiling, on the TikTok video. Seconds later, another young woman, wearing gloves, pushes a hyaluron pen against the first woman’s lips, who, in the next cut, is smiling, happy. “My first syringe down and already 1,000x more confident,” the caption reads.

That video is one of thousands showing hyaluron pen use on TikTok. The pens are sold online and are unapproved – which led to a Food and Drug Administration warning in October 2021 that use could cause bleeding, infection, blood vessel occlusion that could result in blindness or stroke, allergic reactions, and other injuries.

The warning has not stopped many TikTokkers, who also use the medium to promote all sorts of skin and aesthetic products and procedures, a large number unproven, unapproved, or ill advised. As TikTok has become one of the most widely used social media platforms, millions of mostly teenagers regularly log on for skin care advice, which, more often than not, comes from “skinfluencers,” aestheticians, and other laypeople, not board-certified dermatologists.

The suggested “hacks” can be harmless or ineffective, but they also can be misleading, fraudulent, or even dangerous.
 

Skinfluencers take the lead

TikTok has a reported 1 billion monthly users. Two-thirds are aged 10-29 years, according to data reported in February 2021 in the Journal of the American Academy of Dermatology by David X. Zheng, BA, and colleagues at Case Western Reserve University, Cleveland, and the department of dermatology, Johns Hopkins University, Baltimore.

Visitors consume information in video bits that run from 15 seconds to up to 3 minutes and can follow their favorite TikTokkers, browse for people or hashtags with a search function, or click on content recommended by the platform, which uses algorithms based on the user’s viewing habits to determine what might be of interest.

Some of the biggest “skinfluencers” have millions of followers: Hyram Yarbro, (@skincarebyhyram) for instance, has 6.6 million followers and his own line of skin care products at Sephora. Mr. Yarbro is seen as a no-nonsense debunker of skin care myths, as is British influencer James Welsh, who has 124,000 followers.

“The reason why people trust your average influencer person who’s not a doctor is because they’re relatable,” said Muneeb Shah, MD, a dermatology resident at Atlantic Dermatology in Wilmington, N.C. – known to his 11.4 million TikTok followers as @dermdoctor.

To Sandra Lee, MD, the popularity of nonprofessionals is easy to explain. “You have to think about the fact that a lot of people can’t see dermatologists – they don’t have the money, they don’t have the time to travel there, they don’t have health insurance, or they’re scared of doctors, so they’re willing to try to find an answer, and one of the easiest ways, one of the more entertaining ways to get information, is on social media.”

Dr. Lee is in private practice in Upland, Calif., but is better known as “Dr. Pimple Popper,” through her television show of the same name and her social media accounts, including on TikTok, where she has 14.4 million followers after having started in 2020.

“We’re all looking for that no-down-time, no-expense, no-lines, no-wrinkles, stay-young-forever magic bullet,” said Dr. Lee.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, agreed that people are looking for a quick fix. They don’t want to wait 12 weeks for an acne medication or 16 weeks for a biologic to work. “They want something simple, easy, do-it-yourself,” and “natural,” he said.

Laypeople are still the dominant producers – and have the most views – of dermatology content.

Morgan Nguyen, BA, at Northwestern University, Chicago, and colleagues looked at hashtags for the top 10 dermatologic diagnoses and procedures and analyzed the content of the first 40 TikTok videos in each category. About half the videos were produced by an individual, and 39% by a health care provider, according to the study, published in the International Journal of Women’s Dermatology. About 40% of the videos were educational, focusing on skin care, procedures, and disease treatment.

Viewership was highest for videos by laypeople, followed by those produced by business or industry accounts. Those produced by health care providers received only 18% of the views.

The most popular videos were about dermatologic diagnoses, with 2.5 billion views, followed by dermatologic procedures, with 708 million views.

Ms. Nguyen noted in the study that the most liked and most viewed posts were related to #skincare but that board-certified dermatologists produced only 2.5% of the #skincare videos.


 

Dermatologists take to TikTok

Some dermatologists have started their own TikTok accounts, seeking both to counteract misinformation and provide education.

Dr. Shah has become one of the top influencers on the platform. In a year-end wrap, TikTok put Dr. Shah at No. 7 on its top creators list for 2021.

MDedge

Doris Day, MD, who goes by @drdorisday on TikTok, agreed with Dr. Lee. “There are so many creative ways you can convey information with it that’s different than what you have on Instagram,” said Dr. Day, who is in private practice in New York. And, she added, “it does really lend itself to getting points out super-fast.”

Dermatologists on TikTok also said they like the “duets” and the “stitch” features, which allow users to add on to an existing video, essentially chiming in or responding to what might have already been posted, in a side-by-side format.

Dr. Shah said he often duets videos that have questionable content. “It allows me to directly respond to people. A lot of times, if something is going really viral and it’s not accurate, you’ll have a response from me or one of the other doctors” within hours or days.

Dr. Shah’s duets are labeled with “DermDoctor Reacts” or “DermDoctor Explains.” In one duet, with more than 2.8 million views, the upper half of the video is someone squeezing a blackhead, while Dr. Shah, in the bottom half, in green scrubs, opines over some hip-hop music: “This is just a blackhead. But once it gets to this point, they do need to be extracted because topical treatments won’t help.”

TikTok trends gone bad

And some people are being hurt by emulating what they see on TikTok.

Dr. Friedman had a patient with extreme irritant contact dermatitis, “almost like chemical burns to her underarms,” he said. He determined that she saw a video “hack” that recommended using baking soda to stop hyperhidrosis. The patient used so much that it burned her skin.

In 2020, do-it-yourself freckles – with henna or sewing needles impregnated with ink – went viral. Tilly Whitfeld, a 21-year-old reality TV star on Australia’s Big Brother show, told the New York Times that she tried it at home after seeing a TikTok video. She ordered brown tattoo ink online and later found out that it was contaminated with lead, according to the Times. Ms. Whitfeld developed an infection and temporary vision loss and has permanent scarring.

She has since put out a cautionary TikTok video that’s been viewed some 300,000 times.

TikTokkers have also flocked to the idea of using sunscreen to “contour” the face. Selected areas are left without sunscreen to burn or tan. In a duet, a plastic surgeon shakes his head as a young woman explains that “it works.”

Scalp-popping – in which the hair is yanked so hard that it pulls the galea off the skull – has been mostly shut down by TikTok. A search of “scalp popping” brings up the message: “Learn how to recognize harmful challenges and hoaxes.” At-home mole and skin tag removal, pimple-popping, and supposed acne cures such as drinking chlorophyll are all avidly documented and shared on TikTok.

Dr. Shah had a back-and-forth video dialog with someone who had stubbed a toe and then drilled a hole into the nail to drain the hematoma. In a reaction video, Dr. Shah said it was likely to turn into an infection. When it did, the man revealed the infection in a video where he tagged Dr. Shah and later posted a video at the podiatrist’s office having his nail removed, again tagging Dr. Shah.

“I think that pretty much no procedure for skin is good to do at home,” said Dr. Shah, who repeatedly admonishes against mole removal by a nonphysician. He tells followers that “it’s extremely dangerous – not only is it going to cause scarring, but you are potentially discarding a cancerous lesion.”

Unfortunately, most will not follow the advice, said Dr. Shah. That’s especially true of pimple-popping. Aiming for the least harm, he suggests in some TikTok videos that poppers keep the area clean, wear gloves, and consult a physician to get an antibiotic prescription. “You might as well at least guide them in the right direction,” he added.

Dr. Lee believes that lack of access to physicians, insurance, or money may play into how TikTok trends evolve. “Probably those people who injected their lips with this air gun thing, maybe they didn’t have the money necessarily to get filler,” she said.

Also, she noted, while TikTok may try to police its content, creators are incentivized to be outrageous. “The more inflammatory your post is, the more engagement you get.”

Dr. Shah thinks TikTok is self-correcting. “If you’re not being ethical or contradicting yourself, putting out information that’s not accurate, people are going to catch on very quickly,” he said. “The only value, the only currency you have on social media is the trust that you build with people that follow you.”
 

What it takes to be a TikTokker

For dermatologists, conveying their credentials and experience is one way to build that currency. Dr. Lee advised fellow doctors on TikTok to “showcase your training and how many years it took to become a dermatologist.”

Plunging into TikTok is not for everyone, though. It’s time consuming, said Dr. Lee, who now devotes most of her nonclinical time to TikTok. She creates her own content, leaving others to manage her Instagram account.

Many of those in the medical field who have dived into TikTok are residents, like Dr. Shah. “They are attuned to it and understand it more,” said Dr. Lee. “It’s harder for a lot of us who are older, who really weren’t involved that much in social media at all. It’s very hard to jump in.” There’s a learning curve, and it takes hours to create a single video. “You have to enjoy it and it has to be a part of your life,” she said.

Dr. Shah started experimenting with TikTok at the beginning of the pandemic in 2020 and has never turned back. Fast-talking, curious, and with an infectious sense of fun, he shares tidbits about his personal life – putting his wife in some of his videos – and always seems upbeat.

He said that, as his following grew, users began to see him as an authority figure and started “tagging” him more often, seeking his opinion on other videos. Although still a resident, he believes he has specialized knowledge to share. “Even if you’re not the world’s leading expert in a particular topic, you’re still adding value for the person who doesn’t know much.”

Dr. Shah also occasionally does promotional TikToks, identified as sponsored content. He said he only works with companies that he believes have legitimate products. “You do have to monetize at some point,” he said, noting that many dermatologists, himself included, are trading clinic time for TikTok. “There’s no universe where they can do this for free.”

Product endorsements are likely more rewarding for influencers and other users like Dr. Shah than the remuneration from TikTok, the company. The platform pays user accounts $20 per 1 million views, Dr. Shah said. “Financially, it’s not a big winner for a practicing dermatologist, but the educational outreach is worthwhile.”

To be successful also means understanding what drives viewership.

Using “trending” sounds has “been shown to increase the likelihood of a video amassing millions of views” and may increase engagement with dermatologists’ TikTok videos, wrote Bina Kassamali, BA, and colleagues at the Brigham and Women’s Hospital in Boston and the Ponce Health Science University School of Medicine in Ponce, Puerto Rico, in a letter published in the Journal of the American Academy of Dermatology in July 2021.

Certain content is more likely to engage viewers. In their analysis of top trending dermatologic hashtags, acne-related content was viewed 6.7 billion times, followed by alopecia, with 1.1 billion views. Psoriasis content had 84 million views, putting it eighth on the list of topics.

Dermatologists are still cracking TikTok. They are accumulating more followers on TikTok than on Instagram but have greater engagement on Instagram reels, wrote Mindy D. Szeto, MS, and colleagues at the University of Colorado at Denver, Aurora, and Rocky Vista University in Parker, Colo., in the Journal of the American Academy of Dermatology in April 2021.

Dr. Lee and Dr. Shah had the highest engagement rate on TikTok, according to Ms. Szeto. The engagement rate is calculated as (likes + comments per post)/(total followers) x 100.

“TikTok may currently be the leading avenue for audience education by dermatologist influencers,” they wrote, urging dermatologists to use the platform to answer the call as more of the public “continues to turn to social media for medical advice.”

Dr. Day said she will keep trying to build her TikTok audience. She has just 239 followers, compared with her 44,500 on Instagram. “The more I do TikTok, the more I do any of these mediums, the better I get at it,” she said. “We just have to put a little time and effort into it and try to get more followers and just keep sharing the information.”

Dr. Friedman sees it as a positive that some dermatologists have taken to TikTok to dispel myths and put “good information out there in small bites.” But to be more effective, they need more followers.

“The truth is that 14-year-old is probably going to listen more to a Hyram than a dermatologist,” he said. “Maybe we need to work with these other individuals who know how to take these messages and convert them to a language that can be digested by a 14-year-old, by a 12-year-old, by a 23-year-old. We need to come to the table together and not fight.”

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

Progression free survival was better at 2 years when polatuzumab-vedotin (Polivy) was added to a modified R-CHOP regimen for first-line treatment of diffuse large B-cell lymphoma (DLBCL), but there was no difference in overall survival in a phase 3 trial from maker Genentech/Roche.

Two-year progression free survival (PFS) was 76.7% for the 440 patients randomized to polatuzumab-vedotin (PV) add-on, versus 70.2% for the 439 randomized to R-CHOP, which translated to a 27% reduction in the risk of progression, relapse, or death (P = .02). However, overall survival (OS) at 2 years was just under 89% in both arms of the trial, dubbed POLARIX. Toxicity was comparable between the two arms.

The investigators swapped out the vincristine in R-CHOP for PV to avoid overlapping neurotoxic side effects and called their modified regimen “pola-R-CHP.”

“We believe these results support use of pola-R-CHP in the initial management of patients with DLBCL,” senior investigator Gilles Salles, MD, PhD, a hematologic oncologist at Memorial Sloan Cancer Center in New York, said at the American Society of Hematology annual meeting.

The study (ASH 2021 abstract LBA-1), was published simultaneously in the New England Journal of Medicine.
 

Worth the cost?

The investigators reported that the median follow up of 28.2 months may simply have been too short to see if the PFS benefit translates into better overall survival. Also, newer treatments for relapsed/refractory disease might have masked any OS benefit.

With the PFS benefit, however, “what we think we are seeing is a deeper, more profound complete remission that hopefully will translate into [better] overall survival, but it may be a while until that can be demonstrated,” said Jane N. Winter, MD, a hematologic oncologist at Northwestern University, Chicago, who moderated Dr. Salles’ presentation.

“If the improvement in PFS at 2 years represents a true higher cure rate and plateau rather than a simple delay in relapse,” the “results from the POLARIX trial are likely to be practice-changing,” blood cancer specialist Ajay K. Gopal, MD, professor of medicine at the University of Washington, Seattle, told this news organization when asked for comment.

With additional OS results pending, an audience member at ASH wondered if “the cost of this highly expensive monoclonal antibody drug conjugate is worth the small improvement in PFS.”

“We have to further study this point, but at this moment what is important is to have a treatment with better efficacy and no more toxicity” than R-CHOP, lead investigator Herve Tilly, MD, a hematologic oncologist at the University of Rouen, France, said at the meeting.

Dr. Gopal said the cost concerns are legitimate, but also pointed out that they “may be somewhat offset by the potential reduction in downstream use of expensive cellular therapies.”

The findings support his assertion. With reduced PFS, R-CHOP subjects were more likely than were pola-R-CHP subjects to go on to subsequent lines of therapy (30.3% versus 22.5%).

PV is already approved in the United States for relapsed or refractory DLBCL in combination with bendamustine and rituximab after failure of at least two previous regimens.
 

Defining a target population

R-CHOP – rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone – has been the first-line standard of care for DLBCL for 2 decades, but it cures only about 60%-70% of patients. Researchers have tried for years to improve the cure rate by adding novel agents and other means, but outcomes haven’t been clinically meaningful, the investigators explained.

Polatuzumab, the antibody component of PV, zeroes in on a ubiquitous target on mature B-cell lymphomas, delivering vedotin, a potent microtubule inhibitor, directly to tumor cells.

Study subjects were treatment naive and a median of 65 years old with intermediate-risk or high-risk DLBCL. About a third had activated B-cell–like DLBCL, and almost two-thirds had baseline International Prognostic Index (IPI) scores between 3 and 5.

Each arm of the trial underwent six treatment cycles, plus two cycles of rituximab monotherapy.

On subgroup analysis, PFS benefit clustered among higher risk patients, namely patients older than 60 years, those with IPI scores between 3 and 5, and patients with the activated B-cell–like subtype.

Younger patients, subjects with lower IPI scores, patients with bulky disease, and those who had germinal-center B-cell–like DLBCL “did not show a clear [PFS] benefit,” the study team said.
 

Ongoing trial in the elderly

Adverse events in POLARIX were in line with the component drugs’ known toxicity profiles, with no new safety signals identified.

The most common grade 3/4 adverse events were neutropenia (28.3% in the pola-R-CHP group and 30.8% in the R-CHOP group), febrile neutropenia (13.8% and 8.0%, respectively), and anemia (12.0% and 8.4%). A bit over 6% of subjects in both arms discontinued because of adverse events.

The higher incidence of febrile neutropenia with pola-R-CHP “did not translate into a higher overall incidence of infection, treatment discontinuation, or dose reductions,” the investigators said.

They noted that patients with lymphoma arising from previously diagnosed indolent lymphoma, those with a primary mediastinal lymphoma, and people older than 80 years were not included in the study. A phase 3 trial in patients 75 years and up is recruiting.

The work was funded by PV maker Genentech/Roche. Many of the investigators disclosed ties to the companies, including Dr. Tilly, an adviser and speaker for Roche, and Dr. Salles, an adviser for Genentech. Three investigators were Genentech employees. Dr. Gopal is a consultant for Genentech/Roche. Dr. Winter did not have any ties to the companies.

[email protected]

Progression free survival was better at 2 years when polatuzumab-vedotin (Polivy) was added to a modified R-CHOP regimen for first-line treatment of diffuse large B-cell lymphoma (DLBCL), but there was no difference in overall survival in a phase 3 trial from maker Genentech/Roche.

Two-year progression free survival (PFS) was 76.7% for the 440 patients randomized to polatuzumab-vedotin (PV) add-on, versus 70.2% for the 439 randomized to R-CHOP, which translated to a 27% reduction in the risk of progression, relapse, or death (P = .02). However, overall survival (OS) at 2 years was just under 89% in both arms of the trial, dubbed POLARIX. Toxicity was comparable between the two arms.

The investigators swapped out the vincristine in R-CHOP for PV to avoid overlapping neurotoxic side effects and called their modified regimen “pola-R-CHP.”

“We believe these results support use of pola-R-CHP in the initial management of patients with DLBCL,” senior investigator Gilles Salles, MD, PhD, a hematologic oncologist at Memorial Sloan Cancer Center in New York, said at the American Society of Hematology annual meeting.

The study (ASH 2021 abstract LBA-1), was published simultaneously in the New England Journal of Medicine.
 

Worth the cost?

The investigators reported that the median follow up of 28.2 months may simply have been too short to see if the PFS benefit translates into better overall survival. Also, newer treatments for relapsed/refractory disease might have masked any OS benefit.

With the PFS benefit, however, “what we think we are seeing is a deeper, more profound complete remission that hopefully will translate into [better] overall survival, but it may be a while until that can be demonstrated,” said Jane N. Winter, MD, a hematologic oncologist at Northwestern University, Chicago, who moderated Dr. Salles’ presentation.

“If the improvement in PFS at 2 years represents a true higher cure rate and plateau rather than a simple delay in relapse,” the “results from the POLARIX trial are likely to be practice-changing,” blood cancer specialist Ajay K. Gopal, MD, professor of medicine at the University of Washington, Seattle, told this news organization when asked for comment.

With additional OS results pending, an audience member at ASH wondered if “the cost of this highly expensive monoclonal antibody drug conjugate is worth the small improvement in PFS.”

“We have to further study this point, but at this moment what is important is to have a treatment with better efficacy and no more toxicity” than R-CHOP, lead investigator Herve Tilly, MD, a hematologic oncologist at the University of Rouen, France, said at the meeting.

Dr. Gopal said the cost concerns are legitimate, but also pointed out that they “may be somewhat offset by the potential reduction in downstream use of expensive cellular therapies.”

The findings support his assertion. With reduced PFS, R-CHOP subjects were more likely than were pola-R-CHP subjects to go on to subsequent lines of therapy (30.3% versus 22.5%).

PV is already approved in the United States for relapsed or refractory DLBCL in combination with bendamustine and rituximab after failure of at least two previous regimens.
 

Defining a target population

R-CHOP – rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone – has been the first-line standard of care for DLBCL for 2 decades, but it cures only about 60%-70% of patients. Researchers have tried for years to improve the cure rate by adding novel agents and other means, but outcomes haven’t been clinically meaningful, the investigators explained.

Polatuzumab, the antibody component of PV, zeroes in on a ubiquitous target on mature B-cell lymphomas, delivering vedotin, a potent microtubule inhibitor, directly to tumor cells.

Study subjects were treatment naive and a median of 65 years old with intermediate-risk or high-risk DLBCL. About a third had activated B-cell–like DLBCL, and almost two-thirds had baseline International Prognostic Index (IPI) scores between 3 and 5.

Each arm of the trial underwent six treatment cycles, plus two cycles of rituximab monotherapy.

On subgroup analysis, PFS benefit clustered among higher risk patients, namely patients older than 60 years, those with IPI scores between 3 and 5, and patients with the activated B-cell–like subtype.

Younger patients, subjects with lower IPI scores, patients with bulky disease, and those who had germinal-center B-cell–like DLBCL “did not show a clear [PFS] benefit,” the study team said.
 

Ongoing trial in the elderly

Adverse events in POLARIX were in line with the component drugs’ known toxicity profiles, with no new safety signals identified.

The most common grade 3/4 adverse events were neutropenia (28.3% in the pola-R-CHP group and 30.8% in the R-CHOP group), febrile neutropenia (13.8% and 8.0%, respectively), and anemia (12.0% and 8.4%). A bit over 6% of subjects in both arms discontinued because of adverse events.

The higher incidence of febrile neutropenia with pola-R-CHP “did not translate into a higher overall incidence of infection, treatment discontinuation, or dose reductions,” the investigators said.

They noted that patients with lymphoma arising from previously diagnosed indolent lymphoma, those with a primary mediastinal lymphoma, and people older than 80 years were not included in the study. A phase 3 trial in patients 75 years and up is recruiting.

The work was funded by PV maker Genentech/Roche. Many of the investigators disclosed ties to the companies, including Dr. Tilly, an adviser and speaker for Roche, and Dr. Salles, an adviser for Genentech. Three investigators were Genentech employees. Dr. Gopal is a consultant for Genentech/Roche. Dr. Winter did not have any ties to the companies.

[email protected]

Progression free survival was better at 2 years when polatuzumab-vedotin (Polivy) was added to a modified R-CHOP regimen for first-line treatment of diffuse large B-cell lymphoma (DLBCL), but there was no difference in overall survival in a phase 3 trial from maker Genentech/Roche.

Two-year progression free survival (PFS) was 76.7% for the 440 patients randomized to polatuzumab-vedotin (PV) add-on, versus 70.2% for the 439 randomized to R-CHOP, which translated to a 27% reduction in the risk of progression, relapse, or death (P = .02). However, overall survival (OS) at 2 years was just under 89% in both arms of the trial, dubbed POLARIX. Toxicity was comparable between the two arms.

The investigators swapped out the vincristine in R-CHOP for PV to avoid overlapping neurotoxic side effects and called their modified regimen “pola-R-CHP.”

“We believe these results support use of pola-R-CHP in the initial management of patients with DLBCL,” senior investigator Gilles Salles, MD, PhD, a hematologic oncologist at Memorial Sloan Cancer Center in New York, said at the American Society of Hematology annual meeting.

The study (ASH 2021 abstract LBA-1), was published simultaneously in the New England Journal of Medicine.
 

Worth the cost?

The investigators reported that the median follow up of 28.2 months may simply have been too short to see if the PFS benefit translates into better overall survival. Also, newer treatments for relapsed/refractory disease might have masked any OS benefit.

With the PFS benefit, however, “what we think we are seeing is a deeper, more profound complete remission that hopefully will translate into [better] overall survival, but it may be a while until that can be demonstrated,” said Jane N. Winter, MD, a hematologic oncologist at Northwestern University, Chicago, who moderated Dr. Salles’ presentation.

“If the improvement in PFS at 2 years represents a true higher cure rate and plateau rather than a simple delay in relapse,” the “results from the POLARIX trial are likely to be practice-changing,” blood cancer specialist Ajay K. Gopal, MD, professor of medicine at the University of Washington, Seattle, told this news organization when asked for comment.

With additional OS results pending, an audience member at ASH wondered if “the cost of this highly expensive monoclonal antibody drug conjugate is worth the small improvement in PFS.”

“We have to further study this point, but at this moment what is important is to have a treatment with better efficacy and no more toxicity” than R-CHOP, lead investigator Herve Tilly, MD, a hematologic oncologist at the University of Rouen, France, said at the meeting.

Dr. Gopal said the cost concerns are legitimate, but also pointed out that they “may be somewhat offset by the potential reduction in downstream use of expensive cellular therapies.”

The findings support his assertion. With reduced PFS, R-CHOP subjects were more likely than were pola-R-CHP subjects to go on to subsequent lines of therapy (30.3% versus 22.5%).

PV is already approved in the United States for relapsed or refractory DLBCL in combination with bendamustine and rituximab after failure of at least two previous regimens.
 

Defining a target population

R-CHOP – rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone – has been the first-line standard of care for DLBCL for 2 decades, but it cures only about 60%-70% of patients. Researchers have tried for years to improve the cure rate by adding novel agents and other means, but outcomes haven’t been clinically meaningful, the investigators explained.

Polatuzumab, the antibody component of PV, zeroes in on a ubiquitous target on mature B-cell lymphomas, delivering vedotin, a potent microtubule inhibitor, directly to tumor cells.

Study subjects were treatment naive and a median of 65 years old with intermediate-risk or high-risk DLBCL. About a third had activated B-cell–like DLBCL, and almost two-thirds had baseline International Prognostic Index (IPI) scores between 3 and 5.

Each arm of the trial underwent six treatment cycles, plus two cycles of rituximab monotherapy.

On subgroup analysis, PFS benefit clustered among higher risk patients, namely patients older than 60 years, those with IPI scores between 3 and 5, and patients with the activated B-cell–like subtype.

Younger patients, subjects with lower IPI scores, patients with bulky disease, and those who had germinal-center B-cell–like DLBCL “did not show a clear [PFS] benefit,” the study team said.
 

Ongoing trial in the elderly

Adverse events in POLARIX were in line with the component drugs’ known toxicity profiles, with no new safety signals identified.

The most common grade 3/4 adverse events were neutropenia (28.3% in the pola-R-CHP group and 30.8% in the R-CHOP group), febrile neutropenia (13.8% and 8.0%, respectively), and anemia (12.0% and 8.4%). A bit over 6% of subjects in both arms discontinued because of adverse events.

The higher incidence of febrile neutropenia with pola-R-CHP “did not translate into a higher overall incidence of infection, treatment discontinuation, or dose reductions,” the investigators said.

They noted that patients with lymphoma arising from previously diagnosed indolent lymphoma, those with a primary mediastinal lymphoma, and people older than 80 years were not included in the study. A phase 3 trial in patients 75 years and up is recruiting.

The work was funded by PV maker Genentech/Roche. Many of the investigators disclosed ties to the companies, including Dr. Tilly, an adviser and speaker for Roche, and Dr. Salles, an adviser for Genentech. Three investigators were Genentech employees. Dr. Gopal is a consultant for Genentech/Roche. Dr. Winter did not have any ties to the companies.

[email protected]

Women with physical, intellectual, and sensory disabilities had higher risk for almost all pregnancy complications, obstetric interventions, and adverse outcomes, including severe maternal morbidity (SMM) and mortality compared to women without disabilities, according to an analysis of a large, retrospective cohort.

The findings, published in JAMA Network Open (2021;4[12]:e2138414 doi: 10.1001/jamanetworkopen.2021.38414), “may be a direct reflection of the challenges women with all types of disabilities face when accessing and receiving care, which is likely compounded by poorer preconception health,” suggested lead author Jessica L. Gleason, PhD, MPH, and co-authors, all from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md.

“Women with disabilities have long been ignored in obstetric research and clinical practice,” added Hilary K. Brown, PhD, from the University of Toronto, in an accompanying editorial. “Inclusion of disability indicators needs to be the norm – not the exception – in health administrative data so that these disparities can be regularly tracked and addressed.”

The investigators used data from the Consortium on Safe Labor (CSL), a retrospective cohort of deliveries from 12 U.S. clinical centers between Jan. 2002 and Jan. 2008, to analyze obstetric interventions and adverse maternal outcomes in women with and without disabilities.

The analysis included a total of 223,385 women, mean age 27.6 years, of whom 2,074 (0.9%) had a disability, and 221,311 did not. Among those with disabilities, 1,733 (83.5%) were physical, 91 (4.4%) were intellectual, and 250 (12.1%) were sensory. While almost half (49.4%) of the women were White, 22.5% were Black, 17.5% were Hispanic, and 4.1% were Asian or Pacific Islander.

Outcomes were analyzed with three composite measures:

• Pregnancy-related complications (pregnancy-related hypertensive diseases, gestational diabetes, placental abruption, placenta previa, premature rupture of membranes, preterm PROM);
• All labor, delivery, and postpartum complications (chorioamnionitis, hemorrhage, blood transfusion, thromboembolism, postpartum fever, infection, cardiovascular events, cardiomyopathy, and maternal death);
• SMM only, including severe pre-eclampsia/eclampsia, hemorrhage, thromboembolism, fever, infection, cardiomyopathy, and cardiovascular events during labor and delivery.

After adjustment for covariates, women with disabilities had higher risk of pregnancy-related complications. This included a 48% higher risk of mild pre-eclampsia and double the risk of severe pre-eclampsia/eclampsia. The composite risk of any pregnancy complication was 27% higher for women with physical disabilities, 49% higher for women with intellectual disabilities, and 53% higher for women with sensory disabilities.

The findings were similar for labor, delivery, and postpartum complications, showing women with disabilities had higher risk for a range of obstetrical interventions, including cesarean delivery – both planned and intrapartum (aRR, 1.34). Additionally, women with disabilities were less likely to have a cesarean delivery that was “solely clinically indicated” (aRR, 0.79), and more likely to have a cesarean delivery for “softer” mixed indication (aRR, 1.16), “supporting a possible overuse of cesarean delivery among women with disability,” they suggested.

Women with disabilities also had a higher risk of postpartum hemorrhage (aRR, 1.27), blood transfusion (aRR, 1.64), and maternal mortality (aRR, 11.19), as well as individual markers of severe maternal morbidity, such as cardiovascular events (aRR, 4.02), infection (aRR, 2.69), and venous thromboembolism (aRR, 6.08).

The authors speculate that the increased risks for women with disabilities “may be the result of a combination of independent risk factors, including the higher rate of obstetric intervention via cesarean delivery, under-recognition of women with disabilities as a population with higher-risk pregnancies, and lack of health care practitioner knowledge or comfort in managing pregnancies among women with disabilities.”

Dr. Brown noted in her commentary that there is a need for better education of health care professionals in this area. “Given that 12% of reproductive-aged women have a disability, that pregnancy rates are similar among women with and without disabilities, and that women with disabilities are at elevated risk of a range of adverse maternal outcomes, including severe maternal morbidity and maternal mortality, disability modules should be a mandatory component of education for obstetricians and midwives as well as other obstetrical health care professionals.”

Calling the study “a serious wake-up call,” Monika Mitra, PhD, told this publication that the findings highlight the need for “urgent attention” on improving obstetric care for people with disabilities “with a focus on accessibility and inclusion, changing clinical practice to better serve disabled people, integrating disability-related training for health care practitioners, and developing evidence-based interventions to support people with disabilities during this time.” The associate professor and director of the Lurie Institute for Disability Policy, in Brandeis University, Waltham, Mass. said the risk factors for poor outcomes are present early in pregnancy or even preconception. “We know that disabled women report barriers in accessing health care and receive lower-quality care compared to nondisabled women and are more likely to experience poverty, housing and food insecurity, educational and employment barriers, abuse, chronic health conditions, and mental illness than women without disabilities.”

She noted that the study’s sample of people with disabilities was small, and the measure of disability used was based on ICD-9 codes, which captures only severe disabilities. “As noted in the commentary by [Dr.] Brown, our standard sources of health administrative data do not give us the full picture on disability, and we need other, more equitable ways of identifying disability based, for example, on self-reports of activity or participation limitations if we are to be able to understand the effects on obstetric outcomes of health and health care disparities and of social determinants of health. Moreover, researchers have generally not yet begun to incorporate knowledge of the experiences of transgender people during pregnancy, which will impact our measures and study of obstetric outcomes among people with disabilities as well as the language we use.”

The study was supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The study authors and Dr. Brown reported no conflicts of interest. Dr. Mitra receives funding from the NICHD and the National Institute on Disability, Independent Living for research on pregnancy outcomes among people with disabilities.

[email protected]

Women with physical, intellectual, and sensory disabilities had higher risk for almost all pregnancy complications, obstetric interventions, and adverse outcomes, including severe maternal morbidity (SMM) and mortality compared to women without disabilities, according to an analysis of a large, retrospective cohort.

The findings, published in JAMA Network Open (2021;4[12]:e2138414 doi: 10.1001/jamanetworkopen.2021.38414), “may be a direct reflection of the challenges women with all types of disabilities face when accessing and receiving care, which is likely compounded by poorer preconception health,” suggested lead author Jessica L. Gleason, PhD, MPH, and co-authors, all from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md.

“Women with disabilities have long been ignored in obstetric research and clinical practice,” added Hilary K. Brown, PhD, from the University of Toronto, in an accompanying editorial. “Inclusion of disability indicators needs to be the norm – not the exception – in health administrative data so that these disparities can be regularly tracked and addressed.”

The investigators used data from the Consortium on Safe Labor (CSL), a retrospective cohort of deliveries from 12 U.S. clinical centers between Jan. 2002 and Jan. 2008, to analyze obstetric interventions and adverse maternal outcomes in women with and without disabilities.

The analysis included a total of 223,385 women, mean age 27.6 years, of whom 2,074 (0.9%) had a disability, and 221,311 did not. Among those with disabilities, 1,733 (83.5%) were physical, 91 (4.4%) were intellectual, and 250 (12.1%) were sensory. While almost half (49.4%) of the women were White, 22.5% were Black, 17.5% were Hispanic, and 4.1% were Asian or Pacific Islander.

Outcomes were analyzed with three composite measures:

• Pregnancy-related complications (pregnancy-related hypertensive diseases, gestational diabetes, placental abruption, placenta previa, premature rupture of membranes, preterm PROM);
• All labor, delivery, and postpartum complications (chorioamnionitis, hemorrhage, blood transfusion, thromboembolism, postpartum fever, infection, cardiovascular events, cardiomyopathy, and maternal death);
• SMM only, including severe pre-eclampsia/eclampsia, hemorrhage, thromboembolism, fever, infection, cardiomyopathy, and cardiovascular events during labor and delivery.

After adjustment for covariates, women with disabilities had higher risk of pregnancy-related complications. This included a 48% higher risk of mild pre-eclampsia and double the risk of severe pre-eclampsia/eclampsia. The composite risk of any pregnancy complication was 27% higher for women with physical disabilities, 49% higher for women with intellectual disabilities, and 53% higher for women with sensory disabilities.

The findings were similar for labor, delivery, and postpartum complications, showing women with disabilities had higher risk for a range of obstetrical interventions, including cesarean delivery – both planned and intrapartum (aRR, 1.34). Additionally, women with disabilities were less likely to have a cesarean delivery that was “solely clinically indicated” (aRR, 0.79), and more likely to have a cesarean delivery for “softer” mixed indication (aRR, 1.16), “supporting a possible overuse of cesarean delivery among women with disability,” they suggested.

Women with disabilities also had a higher risk of postpartum hemorrhage (aRR, 1.27), blood transfusion (aRR, 1.64), and maternal mortality (aRR, 11.19), as well as individual markers of severe maternal morbidity, such as cardiovascular events (aRR, 4.02), infection (aRR, 2.69), and venous thromboembolism (aRR, 6.08).

The authors speculate that the increased risks for women with disabilities “may be the result of a combination of independent risk factors, including the higher rate of obstetric intervention via cesarean delivery, under-recognition of women with disabilities as a population with higher-risk pregnancies, and lack of health care practitioner knowledge or comfort in managing pregnancies among women with disabilities.”

Dr. Brown noted in her commentary that there is a need for better education of health care professionals in this area. “Given that 12% of reproductive-aged women have a disability, that pregnancy rates are similar among women with and without disabilities, and that women with disabilities are at elevated risk of a range of adverse maternal outcomes, including severe maternal morbidity and maternal mortality, disability modules should be a mandatory component of education for obstetricians and midwives as well as other obstetrical health care professionals.”

Calling the study “a serious wake-up call,” Monika Mitra, PhD, told this publication that the findings highlight the need for “urgent attention” on improving obstetric care for people with disabilities “with a focus on accessibility and inclusion, changing clinical practice to better serve disabled people, integrating disability-related training for health care practitioners, and developing evidence-based interventions to support people with disabilities during this time.” The associate professor and director of the Lurie Institute for Disability Policy, in Brandeis University, Waltham, Mass. said the risk factors for poor outcomes are present early in pregnancy or even preconception. “We know that disabled women report barriers in accessing health care and receive lower-quality care compared to nondisabled women and are more likely to experience poverty, housing and food insecurity, educational and employment barriers, abuse, chronic health conditions, and mental illness than women without disabilities.”

She noted that the study’s sample of people with disabilities was small, and the measure of disability used was based on ICD-9 codes, which captures only severe disabilities. “As noted in the commentary by [Dr.] Brown, our standard sources of health administrative data do not give us the full picture on disability, and we need other, more equitable ways of identifying disability based, for example, on self-reports of activity or participation limitations if we are to be able to understand the effects on obstetric outcomes of health and health care disparities and of social determinants of health. Moreover, researchers have generally not yet begun to incorporate knowledge of the experiences of transgender people during pregnancy, which will impact our measures and study of obstetric outcomes among people with disabilities as well as the language we use.”

The study was supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The study authors and Dr. Brown reported no conflicts of interest. Dr. Mitra receives funding from the NICHD and the National Institute on Disability, Independent Living for research on pregnancy outcomes among people with disabilities.

[email protected]

Women with physical, intellectual, and sensory disabilities had higher risk for almost all pregnancy complications, obstetric interventions, and adverse outcomes, including severe maternal morbidity (SMM) and mortality compared to women without disabilities, according to an analysis of a large, retrospective cohort.

The findings, published in JAMA Network Open (2021;4[12]:e2138414 doi: 10.1001/jamanetworkopen.2021.38414), “may be a direct reflection of the challenges women with all types of disabilities face when accessing and receiving care, which is likely compounded by poorer preconception health,” suggested lead author Jessica L. Gleason, PhD, MPH, and co-authors, all from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Md.

“Women with disabilities have long been ignored in obstetric research and clinical practice,” added Hilary K. Brown, PhD, from the University of Toronto, in an accompanying editorial. “Inclusion of disability indicators needs to be the norm – not the exception – in health administrative data so that these disparities can be regularly tracked and addressed.”

The investigators used data from the Consortium on Safe Labor (CSL), a retrospective cohort of deliveries from 12 U.S. clinical centers between Jan. 2002 and Jan. 2008, to analyze obstetric interventions and adverse maternal outcomes in women with and without disabilities.

The analysis included a total of 223,385 women, mean age 27.6 years, of whom 2,074 (0.9%) had a disability, and 221,311 did not. Among those with disabilities, 1,733 (83.5%) were physical, 91 (4.4%) were intellectual, and 250 (12.1%) were sensory. While almost half (49.4%) of the women were White, 22.5% were Black, 17.5% were Hispanic, and 4.1% were Asian or Pacific Islander.

Outcomes were analyzed with three composite measures:

• Pregnancy-related complications (pregnancy-related hypertensive diseases, gestational diabetes, placental abruption, placenta previa, premature rupture of membranes, preterm PROM);
• All labor, delivery, and postpartum complications (chorioamnionitis, hemorrhage, blood transfusion, thromboembolism, postpartum fever, infection, cardiovascular events, cardiomyopathy, and maternal death);
• SMM only, including severe pre-eclampsia/eclampsia, hemorrhage, thromboembolism, fever, infection, cardiomyopathy, and cardiovascular events during labor and delivery.

After adjustment for covariates, women with disabilities had higher risk of pregnancy-related complications. This included a 48% higher risk of mild pre-eclampsia and double the risk of severe pre-eclampsia/eclampsia. The composite risk of any pregnancy complication was 27% higher for women with physical disabilities, 49% higher for women with intellectual disabilities, and 53% higher for women with sensory disabilities.

The findings were similar for labor, delivery, and postpartum complications, showing women with disabilities had higher risk for a range of obstetrical interventions, including cesarean delivery – both planned and intrapartum (aRR, 1.34). Additionally, women with disabilities were less likely to have a cesarean delivery that was “solely clinically indicated” (aRR, 0.79), and more likely to have a cesarean delivery for “softer” mixed indication (aRR, 1.16), “supporting a possible overuse of cesarean delivery among women with disability,” they suggested.

Women with disabilities also had a higher risk of postpartum hemorrhage (aRR, 1.27), blood transfusion (aRR, 1.64), and maternal mortality (aRR, 11.19), as well as individual markers of severe maternal morbidity, such as cardiovascular events (aRR, 4.02), infection (aRR, 2.69), and venous thromboembolism (aRR, 6.08).

The authors speculate that the increased risks for women with disabilities “may be the result of a combination of independent risk factors, including the higher rate of obstetric intervention via cesarean delivery, under-recognition of women with disabilities as a population with higher-risk pregnancies, and lack of health care practitioner knowledge or comfort in managing pregnancies among women with disabilities.”

Dr. Brown noted in her commentary that there is a need for better education of health care professionals in this area. “Given that 12% of reproductive-aged women have a disability, that pregnancy rates are similar among women with and without disabilities, and that women with disabilities are at elevated risk of a range of adverse maternal outcomes, including severe maternal morbidity and maternal mortality, disability modules should be a mandatory component of education for obstetricians and midwives as well as other obstetrical health care professionals.”

Calling the study “a serious wake-up call,” Monika Mitra, PhD, told this publication that the findings highlight the need for “urgent attention” on improving obstetric care for people with disabilities “with a focus on accessibility and inclusion, changing clinical practice to better serve disabled people, integrating disability-related training for health care practitioners, and developing evidence-based interventions to support people with disabilities during this time.” The associate professor and director of the Lurie Institute for Disability Policy, in Brandeis University, Waltham, Mass. said the risk factors for poor outcomes are present early in pregnancy or even preconception. “We know that disabled women report barriers in accessing health care and receive lower-quality care compared to nondisabled women and are more likely to experience poverty, housing and food insecurity, educational and employment barriers, abuse, chronic health conditions, and mental illness than women without disabilities.”

She noted that the study’s sample of people with disabilities was small, and the measure of disability used was based on ICD-9 codes, which captures only severe disabilities. “As noted in the commentary by [Dr.] Brown, our standard sources of health administrative data do not give us the full picture on disability, and we need other, more equitable ways of identifying disability based, for example, on self-reports of activity or participation limitations if we are to be able to understand the effects on obstetric outcomes of health and health care disparities and of social determinants of health. Moreover, researchers have generally not yet begun to incorporate knowledge of the experiences of transgender people during pregnancy, which will impact our measures and study of obstetric outcomes among people with disabilities as well as the language we use.”

The study was supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The study authors and Dr. Brown reported no conflicts of interest. Dr. Mitra receives funding from the NICHD and the National Institute on Disability, Independent Living for research on pregnancy outcomes among people with disabilities.

[email protected]

The advisory on youth mental health from Surgeon General Vivek Murthy, MD, casts a necessary spotlight on the crisis, clinical psychiatrists say. But some think it could have produced more specifics about funding and payment parity for reimbursement.

The 53-page advisory says that about one in five U.S. children and adolescents aged 3-17 suffer from a mental, emotional, developmental, or behavioral disorder. In the decade before COVID, feelings of sadness and hopelessness, as well as suicidal behaviors, were on the rise. The pandemic has exacerbated symptoms of anxiety, depression, and other mental health issues in young people. Compared with 2019, ED visits in early 2021 for suspected suicide attempts rose 51% in adolescent girls and 4% in boys. “Depressive and anxiety symptoms doubled during the pandemic,” the advisory said.
 

Scope of the advisory

The advisory, released Dec. 7, covers all sectors and considers all social and policy factors that might be contributing to this crisis, said Jessica (Jessi) Gold, MD, MS, an assistant professor in the department of psychiatry at Washington University, St. Louis.

“It is always possible to reimagine health care to be more patient centered and mental health forward.” But changes of this magnitude take time, Dr. Gold, also director of wellness, engagement, and outreach at the university, said in an interview.

She has seen the impact of the pandemic firsthand in her clinic among students and frontline health care workers aged 18-30. People in that age group “feel everything deeply,” Dr. Gold said. Emotions tied to COVID-19 are just a part of it. Confounding factors, such as climate change, racism, and school shootings all contribute to their overall mental health.

Some children and adolescents with social anxiety have fared better during the pandemic, but those who are part of demographic groups such as racial and ethnic minorities, LGBTQ individuals, low-income youth, and those involved in juvenile justice or welfare systems face a higher risk of mental health challenges, the pandemic notwithstanding.

In her work with schools, Denese Shervington, MD, MPH, has witnessed more mental health challenges related to isolation and separation. “There’s an overall worry about the loss of what used to be, the seeming predictability and certainty of prepandemic life,” said Dr. Shervington, clinical professor of psychiatry at Tulane University, and president and CEO of the Institute for Women and Ethnic Studies, both in New Orleans.
 

A systems of care plan

The advisory lists actionable items for health care and 10 other industry sectors to improve mental health of children and young adults.

Health care organizations and professionals were advised to take the following six steps:

• Implement trauma-informed care principles and other prevention strategies. This may involve referring patients to resources such as economic and legal supports, school enrichment programs, and educating families on healthy child development in the clinic.
• Routinely screen children for mental health challenges and risk factors such as adverse childhood experiences during primary care well-visits or annual physicals, or at schools or EDs. Primary care physicians should use principles of trauma-informed care to conduct these screenings.
• Screen parents, caregivers, and other family members for depression, intimate partner violence, substance use, and other challenges. These can be done in tandem with broader assessments of social determinants of health such as food or housing insecurity.
• Combine efforts of clinical staff with trusted community partners and child welfare and juvenile justice. Hospital-based violence intervention programs, for example, identify patients at risk of repeat violent injury and refer them to hospital- and community-based resources.
• Build multidisciplinary teams, enlisting children and families to develop services that are tailored to their needs for screening and treatment. Such services should reflect cultural diversity and offered in multiple languages.
• Support the well-being of mental health workers and community leaders to foster their ability to help youth and their families.

Dr. Murthy is talking about a “systems of care” approach, in which all sectors that touch children and youth – not just health care – must work together and do their jobs effectively but collaboratively to address this public health crisis, said Aradhana (Bela) Sood MD, MSHA, FAACAP, senior professor of child mental health policy at Virginia Commonwealth University, Richmond. “An investment in infrastructure support of positive mental health in early childhood, be it in schools, communities, or family well-being will lead to a future where illness is not the result of major preventable societal factors, such as a lack of social supports and trauma.”
 

Changes will ‘take a lot of buy-in’

The recommendations are actionable in the real world – but there are a lot of them, said Dr. Gold. Dr. Murthy doesn’t specify what the plan is to accomplish these metrics or fund them, she added. He “has money and funders like foundations as steps, but foundations have also suffered in the pandemic, so it is not that simple.” Many of these changes are wide in scope and will take a lot of buy-in.

Dr. Shervington would like to have seen more of a focus on educator well-being, given that young people spend a lot of time in educational settings.

“My organization just completed a study in New Orleans that showed teachers having elevated levels of trauma-based conditions since the pandemic,” she said. Schools are indeed a key place to support holistic mental health by focusing on school climate, Dr. Sood added. “If school administrators became uniformly consistent with recognizing the importance of psychological wellness as a prerequisite of good learning, they will create environments where teachers are keenly aware of a child’s mental wellness and make reduction of bullying, wellness check-ins, [and] school-based mental health clinics a priority.

“These are ways nonmedical, community-based supports can enhance student well-being, and reduce depression and other mental health conditions,” Dr. Sood added.
 

Child psychiatrists stretched ‘even thinner’

Despite mental health parity rules, health plans have not been held accountable. That failure, combined with excessive demands for prior authorization for mental health treatments “have led to dangerous shortages of psychiatrists able to accept insurance,” said Paul S. Nestadt, MD, an assistant professor and public mental health researcher at Johns Hopkins University, Baltimore.

“This is particularly true for child psychiatrists, who are stretched even thinner than those of us in general practice,” Dr. Nestadt said.

While he doesn’t address it head on, Dr. Murthy uses classic parity language when he states that “mental health is no less important than physical health,” said Dr. Nestadt, who consulted with the surgeon general on developing this advisory. “While many of us would have liked to see parity highlighted more directly, this advisory was designed to be an overview.”
 

Highlighting social media, gun violence

Dr. Nestadt said he was pleased that the advisory emphasized the importance of restricting access to lethal means in preventing youth suicide.

“With youth suicide rates rising faster than in other age groups, and suicide mortality tied so closely to method availability, the surgeon general made the right choice in highlighting the role of guns in suicide,” he said.

The advisory also discussed the role of media and social media companies in addressing the crisis, which is important, said Dr. Gold.

“I believe very strongly that the way we talk about and portray mental health in the media matters,” she said. “I have seen it matter in the clinic with patients. They’ll wonder if someone will think they are now violent if they are diagnosed with a mental illness. Stories change the narrative.”

While the advisory isn’t perfect, the state of youth mental health “will only get worse if we don’t do something,” noted Dr. Gold. “It is critical that this is validated and discussed at the highest level and messages like Dr. Murthy’s get heard.”

Dr. Gold, Dr. Shervington, and Dr. Sood had no disclosures. Dr. Nestadt disclosed serving as a consultant to the surgeon general advisory.

The advisory on youth mental health from Surgeon General Vivek Murthy, MD, casts a necessary spotlight on the crisis, clinical psychiatrists say. But some think it could have produced more specifics about funding and payment parity for reimbursement.

The 53-page advisory says that about one in five U.S. children and adolescents aged 3-17 suffer from a mental, emotional, developmental, or behavioral disorder. In the decade before COVID, feelings of sadness and hopelessness, as well as suicidal behaviors, were on the rise. The pandemic has exacerbated symptoms of anxiety, depression, and other mental health issues in young people. Compared with 2019, ED visits in early 2021 for suspected suicide attempts rose 51% in adolescent girls and 4% in boys. “Depressive and anxiety symptoms doubled during the pandemic,” the advisory said.
 

Scope of the advisory

The advisory, released Dec. 7, covers all sectors and considers all social and policy factors that might be contributing to this crisis, said Jessica (Jessi) Gold, MD, MS, an assistant professor in the department of psychiatry at Washington University, St. Louis.

“It is always possible to reimagine health care to be more patient centered and mental health forward.” But changes of this magnitude take time, Dr. Gold, also director of wellness, engagement, and outreach at the university, said in an interview.

She has seen the impact of the pandemic firsthand in her clinic among students and frontline health care workers aged 18-30. People in that age group “feel everything deeply,” Dr. Gold said. Emotions tied to COVID-19 are just a part of it. Confounding factors, such as climate change, racism, and school shootings all contribute to their overall mental health.

Some children and adolescents with social anxiety have fared better during the pandemic, but those who are part of demographic groups such as racial and ethnic minorities, LGBTQ individuals, low-income youth, and those involved in juvenile justice or welfare systems face a higher risk of mental health challenges, the pandemic notwithstanding.

In her work with schools, Denese Shervington, MD, MPH, has witnessed more mental health challenges related to isolation and separation. “There’s an overall worry about the loss of what used to be, the seeming predictability and certainty of prepandemic life,” said Dr. Shervington, clinical professor of psychiatry at Tulane University, and president and CEO of the Institute for Women and Ethnic Studies, both in New Orleans.
 

A systems of care plan

The advisory lists actionable items for health care and 10 other industry sectors to improve mental health of children and young adults.

Health care organizations and professionals were advised to take the following six steps:

• Implement trauma-informed care principles and other prevention strategies. This may involve referring patients to resources such as economic and legal supports, school enrichment programs, and educating families on healthy child development in the clinic.
• Routinely screen children for mental health challenges and risk factors such as adverse childhood experiences during primary care well-visits or annual physicals, or at schools or EDs. Primary care physicians should use principles of trauma-informed care to conduct these screenings.
• Screen parents, caregivers, and other family members for depression, intimate partner violence, substance use, and other challenges. These can be done in tandem with broader assessments of social determinants of health such as food or housing insecurity.
• Combine efforts of clinical staff with trusted community partners and child welfare and juvenile justice. Hospital-based violence intervention programs, for example, identify patients at risk of repeat violent injury and refer them to hospital- and community-based resources.
• Build multidisciplinary teams, enlisting children and families to develop services that are tailored to their needs for screening and treatment. Such services should reflect cultural diversity and offered in multiple languages.
• Support the well-being of mental health workers and community leaders to foster their ability to help youth and their families.

Dr. Murthy is talking about a “systems of care” approach, in which all sectors that touch children and youth – not just health care – must work together and do their jobs effectively but collaboratively to address this public health crisis, said Aradhana (Bela) Sood MD, MSHA, FAACAP, senior professor of child mental health policy at Virginia Commonwealth University, Richmond. “An investment in infrastructure support of positive mental health in early childhood, be it in schools, communities, or family well-being will lead to a future where illness is not the result of major preventable societal factors, such as a lack of social supports and trauma.”
 

Changes will ‘take a lot of buy-in’

The recommendations are actionable in the real world – but there are a lot of them, said Dr. Gold. Dr. Murthy doesn’t specify what the plan is to accomplish these metrics or fund them, she added. He “has money and funders like foundations as steps, but foundations have also suffered in the pandemic, so it is not that simple.” Many of these changes are wide in scope and will take a lot of buy-in.

Dr. Shervington would like to have seen more of a focus on educator well-being, given that young people spend a lot of time in educational settings.

“My organization just completed a study in New Orleans that showed teachers having elevated levels of trauma-based conditions since the pandemic,” she said. Schools are indeed a key place to support holistic mental health by focusing on school climate, Dr. Sood added. “If school administrators became uniformly consistent with recognizing the importance of psychological wellness as a prerequisite of good learning, they will create environments where teachers are keenly aware of a child’s mental wellness and make reduction of bullying, wellness check-ins, [and] school-based mental health clinics a priority.

“These are ways nonmedical, community-based supports can enhance student well-being, and reduce depression and other mental health conditions,” Dr. Sood added.
 

Child psychiatrists stretched ‘even thinner’

Despite mental health parity rules, health plans have not been held accountable. That failure, combined with excessive demands for prior authorization for mental health treatments “have led to dangerous shortages of psychiatrists able to accept insurance,” said Paul S. Nestadt, MD, an assistant professor and public mental health researcher at Johns Hopkins University, Baltimore.

“This is particularly true for child psychiatrists, who are stretched even thinner than those of us in general practice,” Dr. Nestadt said.

While he doesn’t address it head on, Dr. Murthy uses classic parity language when he states that “mental health is no less important than physical health,” said Dr. Nestadt, who consulted with the surgeon general on developing this advisory. “While many of us would have liked to see parity highlighted more directly, this advisory was designed to be an overview.”
 

Highlighting social media, gun violence

Dr. Nestadt said he was pleased that the advisory emphasized the importance of restricting access to lethal means in preventing youth suicide.

“With youth suicide rates rising faster than in other age groups, and suicide mortality tied so closely to method availability, the surgeon general made the right choice in highlighting the role of guns in suicide,” he said.

The advisory also discussed the role of media and social media companies in addressing the crisis, which is important, said Dr. Gold.

“I believe very strongly that the way we talk about and portray mental health in the media matters,” she said. “I have seen it matter in the clinic with patients. They’ll wonder if someone will think they are now violent if they are diagnosed with a mental illness. Stories change the narrative.”

While the advisory isn’t perfect, the state of youth mental health “will only get worse if we don’t do something,” noted Dr. Gold. “It is critical that this is validated and discussed at the highest level and messages like Dr. Murthy’s get heard.”

Dr. Gold, Dr. Shervington, and Dr. Sood had no disclosures. Dr. Nestadt disclosed serving as a consultant to the surgeon general advisory.

The advisory on youth mental health from Surgeon General Vivek Murthy, MD, casts a necessary spotlight on the crisis, clinical psychiatrists say. But some think it could have produced more specifics about funding and payment parity for reimbursement.

The 53-page advisory says that about one in five U.S. children and adolescents aged 3-17 suffer from a mental, emotional, developmental, or behavioral disorder. In the decade before COVID, feelings of sadness and hopelessness, as well as suicidal behaviors, were on the rise. The pandemic has exacerbated symptoms of anxiety, depression, and other mental health issues in young people. Compared with 2019, ED visits in early 2021 for suspected suicide attempts rose 51% in adolescent girls and 4% in boys. “Depressive and anxiety symptoms doubled during the pandemic,” the advisory said.
 

Scope of the advisory

The advisory, released Dec. 7, covers all sectors and considers all social and policy factors that might be contributing to this crisis, said Jessica (Jessi) Gold, MD, MS, an assistant professor in the department of psychiatry at Washington University, St. Louis.

“It is always possible to reimagine health care to be more patient centered and mental health forward.” But changes of this magnitude take time, Dr. Gold, also director of wellness, engagement, and outreach at the university, said in an interview.

She has seen the impact of the pandemic firsthand in her clinic among students and frontline health care workers aged 18-30. People in that age group “feel everything deeply,” Dr. Gold said. Emotions tied to COVID-19 are just a part of it. Confounding factors, such as climate change, racism, and school shootings all contribute to their overall mental health.

Some children and adolescents with social anxiety have fared better during the pandemic, but those who are part of demographic groups such as racial and ethnic minorities, LGBTQ individuals, low-income youth, and those involved in juvenile justice or welfare systems face a higher risk of mental health challenges, the pandemic notwithstanding.

In her work with schools, Denese Shervington, MD, MPH, has witnessed more mental health challenges related to isolation and separation. “There’s an overall worry about the loss of what used to be, the seeming predictability and certainty of prepandemic life,” said Dr. Shervington, clinical professor of psychiatry at Tulane University, and president and CEO of the Institute for Women and Ethnic Studies, both in New Orleans.
 

A systems of care plan

The advisory lists actionable items for health care and 10 other industry sectors to improve mental health of children and young adults.

Health care organizations and professionals were advised to take the following six steps:

• Implement trauma-informed care principles and other prevention strategies. This may involve referring patients to resources such as economic and legal supports, school enrichment programs, and educating families on healthy child development in the clinic.
• Routinely screen children for mental health challenges and risk factors such as adverse childhood experiences during primary care well-visits or annual physicals, or at schools or EDs. Primary care physicians should use principles of trauma-informed care to conduct these screenings.
• Screen parents, caregivers, and other family members for depression, intimate partner violence, substance use, and other challenges. These can be done in tandem with broader assessments of social determinants of health such as food or housing insecurity.
• Combine efforts of clinical staff with trusted community partners and child welfare and juvenile justice. Hospital-based violence intervention programs, for example, identify patients at risk of repeat violent injury and refer them to hospital- and community-based resources.
• Build multidisciplinary teams, enlisting children and families to develop services that are tailored to their needs for screening and treatment. Such services should reflect cultural diversity and offered in multiple languages.
• Support the well-being of mental health workers and community leaders to foster their ability to help youth and their families.

Dr. Murthy is talking about a “systems of care” approach, in which all sectors that touch children and youth – not just health care – must work together and do their jobs effectively but collaboratively to address this public health crisis, said Aradhana (Bela) Sood MD, MSHA, FAACAP, senior professor of child mental health policy at Virginia Commonwealth University, Richmond. “An investment in infrastructure support of positive mental health in early childhood, be it in schools, communities, or family well-being will lead to a future where illness is not the result of major preventable societal factors, such as a lack of social supports and trauma.”
 

Changes will ‘take a lot of buy-in’

The recommendations are actionable in the real world – but there are a lot of them, said Dr. Gold. Dr. Murthy doesn’t specify what the plan is to accomplish these metrics or fund them, she added. He “has money and funders like foundations as steps, but foundations have also suffered in the pandemic, so it is not that simple.” Many of these changes are wide in scope and will take a lot of buy-in.

Dr. Shervington would like to have seen more of a focus on educator well-being, given that young people spend a lot of time in educational settings.

“My organization just completed a study in New Orleans that showed teachers having elevated levels of trauma-based conditions since the pandemic,” she said. Schools are indeed a key place to support holistic mental health by focusing on school climate, Dr. Sood added. “If school administrators became uniformly consistent with recognizing the importance of psychological wellness as a prerequisite of good learning, they will create environments where teachers are keenly aware of a child’s mental wellness and make reduction of bullying, wellness check-ins, [and] school-based mental health clinics a priority.

“These are ways nonmedical, community-based supports can enhance student well-being, and reduce depression and other mental health conditions,” Dr. Sood added.
 

Child psychiatrists stretched ‘even thinner’

Despite mental health parity rules, health plans have not been held accountable. That failure, combined with excessive demands for prior authorization for mental health treatments “have led to dangerous shortages of psychiatrists able to accept insurance,” said Paul S. Nestadt, MD, an assistant professor and public mental health researcher at Johns Hopkins University, Baltimore.

“This is particularly true for child psychiatrists, who are stretched even thinner than those of us in general practice,” Dr. Nestadt said.

While he doesn’t address it head on, Dr. Murthy uses classic parity language when he states that “mental health is no less important than physical health,” said Dr. Nestadt, who consulted with the surgeon general on developing this advisory. “While many of us would have liked to see parity highlighted more directly, this advisory was designed to be an overview.”
 

Highlighting social media, gun violence

Dr. Nestadt said he was pleased that the advisory emphasized the importance of restricting access to lethal means in preventing youth suicide.

“With youth suicide rates rising faster than in other age groups, and suicide mortality tied so closely to method availability, the surgeon general made the right choice in highlighting the role of guns in suicide,” he said.

The advisory also discussed the role of media and social media companies in addressing the crisis, which is important, said Dr. Gold.

“I believe very strongly that the way we talk about and portray mental health in the media matters,” she said. “I have seen it matter in the clinic with patients. They’ll wonder if someone will think they are now violent if they are diagnosed with a mental illness. Stories change the narrative.”

While the advisory isn’t perfect, the state of youth mental health “will only get worse if we don’t do something,” noted Dr. Gold. “It is critical that this is validated and discussed at the highest level and messages like Dr. Murthy’s get heard.”

Dr. Gold, Dr. Shervington, and Dr. Sood had no disclosures. Dr. Nestadt disclosed serving as a consultant to the surgeon general advisory.

A panel of experts that advises the Centers for Disease Control and Prevention on the use of vaccines said the Pfizer and Moderna mRNA COVID-19 vaccines should be the preferred shots for adults in the United States because the Johnson & Johnson shot carries the risk of a rare but potentially fatal side effect that causes blood clots and bleeding in the brain.

In an emergency meeting on December 16, the CDC’s Advisory Committee on Immunization Practices, or ACIP, voted unanimously (15-0) to state a preference for the mRNA vaccines over the Johnson & Johnson shot. The vote came after the panel heard a safety update on cases of thrombosis with thrombocytopenia syndrome, or TTS, a condition that causes large clots that deplete the blood of platelets, resulting in uncontrolled bleeding.

The move brings the United States in line with other wealthy countries. In May, Denmark dropped the Johnson & Johnson shot from its vaccination program because of this risk. Australia and Greece have limited the use of a similar vaccine, made by AstraZeneca, in younger people because of the TTS risk. Both vaccines use the envelope of a different kind of virus, called an adenovirus, to sneak the vaccine instructions into cells. On Dec. 16, health officials said they had determined that TTS was likely due to a class effect, meaning it happens with all adenovirus vector vaccines.

The risk of dying from TTS after a Johnson & Johnson shot is extremely rare. There is an estimated 1 death for every 2 million doses of the vaccine given in the general population. That risk is higher for women ages 30 to 49, rising to about 2 deaths for every 1 million doses given in this age group. There’s no question that the Johnson & Johnson shot has saved many more lives than it has taken, experts said

Still, the committee previously paused the use of the Johnson & Johnson vaccine in April after the first cases of TTS came to light. That pause was lifted just 10 days later, after a new warning was added to the vaccine’s label to raise awareness of the risk.

In updating the safety information on Johnson & Johnson, the panel noted that the warning label had not sufficiently lowered the risk of death from TTS. Doctors seem to be aware of the condition because none of the patients who had developed TTS had been treated with the blood thinner heparin, which can make the syndrome worse. But patients continued to die even after the label was added, the panel noted, because TTS can progress so quickly that doctors simply don’t have time to treat it.

For that reason, and because there are other, safer vaccines available, the panel decided to make what’s called a preferential statement, saying the Pfizer and Moderna mRNA vaccines should be preferred over Johnson & Johnson.

The statement leaves the J&J vaccine on the market and available to patients who are at risk of a severe allergic reaction to the mRNA vaccines. It also means that people can still choose the J&J vaccine if they still want it after being informed about the risks.

About 17 million first doses and 900,000 second doses of the Johnson & Johnson vaccine have been given in the United States. Through the end of August, 54 cases of thrombosis with thrombocytopenia syndrome (TTS) have occurred after the J&J shots in the United States. Nearly half of those were in women ages 30 to 49. There have been nine deaths from TTS after Johnson & Johnson shots.

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

A panel of experts that advises the Centers for Disease Control and Prevention on the use of vaccines said the Pfizer and Moderna mRNA COVID-19 vaccines should be the preferred shots for adults in the United States because the Johnson & Johnson shot carries the risk of a rare but potentially fatal side effect that causes blood clots and bleeding in the brain.

In an emergency meeting on December 16, the CDC’s Advisory Committee on Immunization Practices, or ACIP, voted unanimously (15-0) to state a preference for the mRNA vaccines over the Johnson & Johnson shot. The vote came after the panel heard a safety update on cases of thrombosis with thrombocytopenia syndrome, or TTS, a condition that causes large clots that deplete the blood of platelets, resulting in uncontrolled bleeding.

The move brings the United States in line with other wealthy countries. In May, Denmark dropped the Johnson & Johnson shot from its vaccination program because of this risk. Australia and Greece have limited the use of a similar vaccine, made by AstraZeneca, in younger people because of the TTS risk. Both vaccines use the envelope of a different kind of virus, called an adenovirus, to sneak the vaccine instructions into cells. On Dec. 16, health officials said they had determined that TTS was likely due to a class effect, meaning it happens with all adenovirus vector vaccines.

The risk of dying from TTS after a Johnson & Johnson shot is extremely rare. There is an estimated 1 death for every 2 million doses of the vaccine given in the general population. That risk is higher for women ages 30 to 49, rising to about 2 deaths for every 1 million doses given in this age group. There’s no question that the Johnson & Johnson shot has saved many more lives than it has taken, experts said

Still, the committee previously paused the use of the Johnson & Johnson vaccine in April after the first cases of TTS came to light. That pause was lifted just 10 days later, after a new warning was added to the vaccine’s label to raise awareness of the risk.

In updating the safety information on Johnson & Johnson, the panel noted that the warning label had not sufficiently lowered the risk of death from TTS. Doctors seem to be aware of the condition because none of the patients who had developed TTS had been treated with the blood thinner heparin, which can make the syndrome worse. But patients continued to die even after the label was added, the panel noted, because TTS can progress so quickly that doctors simply don’t have time to treat it.

For that reason, and because there are other, safer vaccines available, the panel decided to make what’s called a preferential statement, saying the Pfizer and Moderna mRNA vaccines should be preferred over Johnson & Johnson.

The statement leaves the J&J vaccine on the market and available to patients who are at risk of a severe allergic reaction to the mRNA vaccines. It also means that people can still choose the J&J vaccine if they still want it after being informed about the risks.

About 17 million first doses and 900,000 second doses of the Johnson & Johnson vaccine have been given in the United States. Through the end of August, 54 cases of thrombosis with thrombocytopenia syndrome (TTS) have occurred after the J&J shots in the United States. Nearly half of those were in women ages 30 to 49. There have been nine deaths from TTS after Johnson & Johnson shots.

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

A panel of experts that advises the Centers for Disease Control and Prevention on the use of vaccines said the Pfizer and Moderna mRNA COVID-19 vaccines should be the preferred shots for adults in the United States because the Johnson & Johnson shot carries the risk of a rare but potentially fatal side effect that causes blood clots and bleeding in the brain.

In an emergency meeting on December 16, the CDC’s Advisory Committee on Immunization Practices, or ACIP, voted unanimously (15-0) to state a preference for the mRNA vaccines over the Johnson & Johnson shot. The vote came after the panel heard a safety update on cases of thrombosis with thrombocytopenia syndrome, or TTS, a condition that causes large clots that deplete the blood of platelets, resulting in uncontrolled bleeding.

The move brings the United States in line with other wealthy countries. In May, Denmark dropped the Johnson & Johnson shot from its vaccination program because of this risk. Australia and Greece have limited the use of a similar vaccine, made by AstraZeneca, in younger people because of the TTS risk. Both vaccines use the envelope of a different kind of virus, called an adenovirus, to sneak the vaccine instructions into cells. On Dec. 16, health officials said they had determined that TTS was likely due to a class effect, meaning it happens with all adenovirus vector vaccines.

The risk of dying from TTS after a Johnson & Johnson shot is extremely rare. There is an estimated 1 death for every 2 million doses of the vaccine given in the general population. That risk is higher for women ages 30 to 49, rising to about 2 deaths for every 1 million doses given in this age group. There’s no question that the Johnson & Johnson shot has saved many more lives than it has taken, experts said

Still, the committee previously paused the use of the Johnson & Johnson vaccine in April after the first cases of TTS came to light. That pause was lifted just 10 days later, after a new warning was added to the vaccine’s label to raise awareness of the risk.

In updating the safety information on Johnson & Johnson, the panel noted that the warning label had not sufficiently lowered the risk of death from TTS. Doctors seem to be aware of the condition because none of the patients who had developed TTS had been treated with the blood thinner heparin, which can make the syndrome worse. But patients continued to die even after the label was added, the panel noted, because TTS can progress so quickly that doctors simply don’t have time to treat it.

For that reason, and because there are other, safer vaccines available, the panel decided to make what’s called a preferential statement, saying the Pfizer and Moderna mRNA vaccines should be preferred over Johnson & Johnson.

The statement leaves the J&J vaccine on the market and available to patients who are at risk of a severe allergic reaction to the mRNA vaccines. It also means that people can still choose the J&J vaccine if they still want it after being informed about the risks.

About 17 million first doses and 900,000 second doses of the Johnson & Johnson vaccine have been given in the United States. Through the end of August, 54 cases of thrombosis with thrombocytopenia syndrome (TTS) have occurred after the J&J shots in the United States. Nearly half of those were in women ages 30 to 49. There have been nine deaths from TTS after Johnson & Johnson shots.

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

ATLANTA – Virtual clinic visits have enabled sickle cell disease patients to stay alive and healthier during the COVID-19 pandemic, but concerns remain for those who lack access to specialized care centers, according to an investigator at the annual meeting of the American Society of Hematology.

During the first COVID-19 wave in the summer of 2020, Atlanta’s Grady Sickle Cell Center, the nation’s largest adult sickle cell center, recorded two deaths among the 20 COVID-19_infected patients seen there, said Fuad El Rassi, MD, of Emory University, Atlanta.

ASH

ATLANTA – Virtual clinic visits have enabled sickle cell disease patients to stay alive and healthier during the COVID-19 pandemic, but concerns remain for those who lack access to specialized care centers, according to an investigator at the annual meeting of the American Society of Hematology.

During the first COVID-19 wave in the summer of 2020, Atlanta’s Grady Sickle Cell Center, the nation’s largest adult sickle cell center, recorded two deaths among the 20 COVID-19_infected patients seen there, said Fuad El Rassi, MD, of Emory University, Atlanta.

ASH

ATLANTA – Virtual clinic visits have enabled sickle cell disease patients to stay alive and healthier during the COVID-19 pandemic, but concerns remain for those who lack access to specialized care centers, according to an investigator at the annual meeting of the American Society of Hematology.

During the first COVID-19 wave in the summer of 2020, Atlanta’s Grady Sickle Cell Center, the nation’s largest adult sickle cell center, recorded two deaths among the 20 COVID-19_infected patients seen there, said Fuad El Rassi, MD, of Emory University, Atlanta.

ASH

The Food and Drug Administration approved a supplemental new drug application for tofacitinib (Xeljanz, Xeljanz XR) that adds active ankylosing spondylitis in adults to its list of indications, according to a Dec. 14 announcement from manufacturer Pfizer.

The approval makes the drug the first Janus kinase (JAK) inhibitor to be approved for ankylosing spondylitis, joining tofacitinib’s other indications of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular-course juvenile idiopathic arthritis.

Like other JAK inhibitors that are indicated for immune-mediated inflammatory diseases, tofacitinib’s use for all indications is limited to patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

The agency based its decision on the results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in 269 adults with active ankylosing spondylitis that tested tofacitinib 5 mg twice daily.

The study met its primary endpoint showing that at week 16 the percentage of tofacitinib-treated patients who achieved 20% improvement in Assessment in SpondyloArthritis International Society response criteria (ASAS20) was significantly greater than with placebo (56.4% vs. 29.4%; P < .0001). The percentage of responders for ASAS40 criteria was likewise significantly greater with tofacitinib vs. placebo (40.6% vs. 12.5%; P < .0001). Pfizer said that the safety profile of tofacitinib observed in patients with ankylosing spondylitis was consistent with the safety profile observed in patients with either rheumatoid arthritis or psoriatic arthritis.

Pfizer noted in its announcement that the FDA updated the prescribing information this month for tofacitinib (and other JAK inhibitors approved for immune-mediated inflammatory conditions, upadacitinib [Rinvoq] and baricitinib [Olumiant]). This update included a new boxed warning for major adverse cardiovascular events and updated boxed warnings regarding mortality, malignancies, and thrombosis. These changes were made in light of results from the ORAL Surveillance postmarketing study of patients with rheumatoid arthritis aged 50 years and older with at least one cardiovascular risk factor. That study found an association between tofacitinib and increased risk of heart attack or stroke, cancer, blood clots, and death in comparison with patients who took the TNF blockers adalimumab or etanercept.

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

The Food and Drug Administration approved a supplemental new drug application for tofacitinib (Xeljanz, Xeljanz XR) that adds active ankylosing spondylitis in adults to its list of indications, according to a Dec. 14 announcement from manufacturer Pfizer.

The approval makes the drug the first Janus kinase (JAK) inhibitor to be approved for ankylosing spondylitis, joining tofacitinib’s other indications of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular-course juvenile idiopathic arthritis.

Like other JAK inhibitors that are indicated for immune-mediated inflammatory diseases, tofacitinib’s use for all indications is limited to patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

The agency based its decision on the results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in 269 adults with active ankylosing spondylitis that tested tofacitinib 5 mg twice daily.

The study met its primary endpoint showing that at week 16 the percentage of tofacitinib-treated patients who achieved 20% improvement in Assessment in SpondyloArthritis International Society response criteria (ASAS20) was significantly greater than with placebo (56.4% vs. 29.4%; P < .0001). The percentage of responders for ASAS40 criteria was likewise significantly greater with tofacitinib vs. placebo (40.6% vs. 12.5%; P < .0001). Pfizer said that the safety profile of tofacitinib observed in patients with ankylosing spondylitis was consistent with the safety profile observed in patients with either rheumatoid arthritis or psoriatic arthritis.

Pfizer noted in its announcement that the FDA updated the prescribing information this month for tofacitinib (and other JAK inhibitors approved for immune-mediated inflammatory conditions, upadacitinib [Rinvoq] and baricitinib [Olumiant]). This update included a new boxed warning for major adverse cardiovascular events and updated boxed warnings regarding mortality, malignancies, and thrombosis. These changes were made in light of results from the ORAL Surveillance postmarketing study of patients with rheumatoid arthritis aged 50 years and older with at least one cardiovascular risk factor. That study found an association between tofacitinib and increased risk of heart attack or stroke, cancer, blood clots, and death in comparison with patients who took the TNF blockers adalimumab or etanercept.

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

The Food and Drug Administration approved a supplemental new drug application for tofacitinib (Xeljanz, Xeljanz XR) that adds active ankylosing spondylitis in adults to its list of indications, according to a Dec. 14 announcement from manufacturer Pfizer.

The approval makes the drug the first Janus kinase (JAK) inhibitor to be approved for ankylosing spondylitis, joining tofacitinib’s other indications of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular-course juvenile idiopathic arthritis.

Like other JAK inhibitors that are indicated for immune-mediated inflammatory diseases, tofacitinib’s use for all indications is limited to patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

The agency based its decision on the results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in 269 adults with active ankylosing spondylitis that tested tofacitinib 5 mg twice daily.

The study met its primary endpoint showing that at week 16 the percentage of tofacitinib-treated patients who achieved 20% improvement in Assessment in SpondyloArthritis International Society response criteria (ASAS20) was significantly greater than with placebo (56.4% vs. 29.4%; P < .0001). The percentage of responders for ASAS40 criteria was likewise significantly greater with tofacitinib vs. placebo (40.6% vs. 12.5%; P < .0001). Pfizer said that the safety profile of tofacitinib observed in patients with ankylosing spondylitis was consistent with the safety profile observed in patients with either rheumatoid arthritis or psoriatic arthritis.

Pfizer noted in its announcement that the FDA updated the prescribing information this month for tofacitinib (and other JAK inhibitors approved for immune-mediated inflammatory conditions, upadacitinib [Rinvoq] and baricitinib [Olumiant]). This update included a new boxed warning for major adverse cardiovascular events and updated boxed warnings regarding mortality, malignancies, and thrombosis. These changes were made in light of results from the ORAL Surveillance postmarketing study of patients with rheumatoid arthritis aged 50 years and older with at least one cardiovascular risk factor. That study found an association between tofacitinib and increased risk of heart attack or stroke, cancer, blood clots, and death in comparison with patients who took the TNF blockers adalimumab or etanercept.

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

On March 11, 2020, the World Health Organization declared the novel coronavirus disease (COVID-19) to be a global pandemic. Shortly after, federal regulators temporarily relaxed restrictions, raised Medicare payment for telemedicine visits to the same level as in-person visits, and waived or reduced cost sharing for patients. As pandemic-related regulations expire, policymakers are debating the need to address insurance coverage of telemedicine services going forward. Congress should consider the lessons learned over the past 20 months to ensure that health care providers have the flexibility to meet the needs of patients.

One of my early telehealth visits was with a patient in his 80s who spent nearly a month in the hospital after complex abdominal surgery. While at home with his daughter, it was the first visit to assess his progress after discharge from the hospital. We were able to address his concerns, assess his wounds using the video on his computer, and formulate a plan so he could continue to improve. At the end of the call, his daughter mentioned in passing, “Thank God we did not have to go to the office ... that would have been a nightmare.”

The nightmare would have consisted of driving her frail father 45 minutes to our office, spending 15 minutes to park, waiting for 30 minutes to be seen, and finally speaking with the physician for 30 minutes face-to-face. Following the appointment, my patient and his daughter would spend another 10 minutes checking out before the 45-minute drive home. Instead, they spent a few minutes logging on through a computer prior to the 30-minute visit from the comfort of their couch.

The COVID-19 pandemic has resulted in millions of deaths and trillions of dollars in economic loss, as well as changed the norms of social interaction. One of the many ways it impacted our health care system is through the exponential growth of telehealth – the use of telecommunication modalities, such as telephone and real-time video – to connect patients with clinicians for the purpose of providing health care.

Prior to the pandemic, telehealth was limited to populations with limited access to health care. Our practice had never performed telehealth, yet converted nearly exclusively to telehealth at the height of the pandemic. My colleagues and I were concerned about how patients and physicians would respond to the sudden disruption of norms of patient engagement.

To measure the response, we conducted an online survey of over 500 gastroenterologists and nearly 1,500 patients from March to May 2020 to assess their satisfaction with telehealth. Our published results demonstrated that more than 80% of patients and 90% of physicians surveyed were either satisfied or highly satisfied with telehealth. Surprisingly, these trends were true irrespective of age or the reason for a visit. Greater than 80% of patients also indicated that the provider addressed their concerns and that they were willing to participate in telehealth visits in the future.

In a subsequent survey of nearly 3,000 patients who had experience with telehealth and in-person visits, 73% of respondents indicated that they received a similar quality of care through telehealth as compared to in-person visits and 61% stated that the interaction with their physician was also similar. More than half of the patients (54%) were likely to continue using telehealth services after the pandemic mainly because of shorter wait and travel times (75%), flexibility with personal schedule (56%), and ease of scheduling appointments on a desired date (47%).

During the COVID-19 pandemic, access to health care has been limited for a great number of patients, and telehealth has been a useful and necessary tool in overcoming this challenge. Telehealth also promotes the triple aim of improving health care by improving the care experience, reducing cost, and improving patient and population health outcomes. Our findings showed a high level of overall patient and provider satisfaction following telehealth appointments. Telehealth increases access to care by decreasing travel time and cost, limiting missed workdays, and reducing the need to find alternative caregivers, especially among rural communities and people facing financial hardship. For a small subset of people who lack the resources, access to technology, or ability to do video visits, telephone-only visits are an appropriate option and should be preserved and reimbursed in some capacity.

From a patient perspective, convenience and decreased cost are often cited as major reasons for satisfaction with telehealth. This is of particular importance to people with limited mobility, nontraditional work hours, and lower socioeconomic status. For patients who use public transportation or caregivers to travel to appointments, a short appointment may require hours of logistical planning and may come at significant financial cost. Enabling these patients to interact with their providers from home would make accessing the health care system both less expensive and logistically less challenging.

One unexpected benefit of telehealth that I have experienced is the ability to “visit” the patients in their own surroundings. Many telehealth visits have allowed the doctor to make a “house call” and see the patients in their homes, cars, and break rooms. Observing the chaos in a home or an extremely quiet and dark space has given me insight into the role anxiety and depression might play in health conditions – which may have not been appreciated in a visit to my office.

The most memorable meeting was a man who was sitting in his kitchen while smoking a cigarette and drinking a beer for breakfast whose main complaint was heartburn. His life habits were obviously contributing to his heartburn, and this degree of insight would not have been appreciated during a traditional in-person office visit.

Congress is now contemplating the role telehealth will play in health care once the pandemic is over. The main concerns are abuse of telehealth by providers, leading to a dramatic rise in visits due to the ease of care delivery. This in turn can dramatically increase health care costs. The long-term health outcomes of patients seen through telehealth are also unknown and must be studied.

All these concerns are valid and must be addressed in future studies, but it would be a mistake for Congress to revert telehealth back to prepandemic regulations. We must move forward with this important innovation in care delivery.

The adoption of telehealth is one of few silver linings of the COVID-19 pandemic. It will never replace in-person visits but should be preserved as an additional tool we can use when in-person visits are not the best option. The future of U.S. health care must allow for a hybrid model so that patients and providers can continue to benefit from this valuable innovation. Patients, providers, and families will be forever grateful.
 

Naresh Gunaratnam MD, AGAF is a practicing gastroenterologist with Huron Gastroenterology in Ann Arbor, Mich. He also serves as the chair of data analytics as a member of the Digestive Health Physicians Association executive committee. Dr. Gunaratnam has no conflicts in telehealth. He is the founder of and CMO of a weight loss device company and service.

On March 11, 2020, the World Health Organization declared the novel coronavirus disease (COVID-19) to be a global pandemic. Shortly after, federal regulators temporarily relaxed restrictions, raised Medicare payment for telemedicine visits to the same level as in-person visits, and waived or reduced cost sharing for patients. As pandemic-related regulations expire, policymakers are debating the need to address insurance coverage of telemedicine services going forward. Congress should consider the lessons learned over the past 20 months to ensure that health care providers have the flexibility to meet the needs of patients.

One of my early telehealth visits was with a patient in his 80s who spent nearly a month in the hospital after complex abdominal surgery. While at home with his daughter, it was the first visit to assess his progress after discharge from the hospital. We were able to address his concerns, assess his wounds using the video on his computer, and formulate a plan so he could continue to improve. At the end of the call, his daughter mentioned in passing, “Thank God we did not have to go to the office ... that would have been a nightmare.”

The nightmare would have consisted of driving her frail father 45 minutes to our office, spending 15 minutes to park, waiting for 30 minutes to be seen, and finally speaking with the physician for 30 minutes face-to-face. Following the appointment, my patient and his daughter would spend another 10 minutes checking out before the 45-minute drive home. Instead, they spent a few minutes logging on through a computer prior to the 30-minute visit from the comfort of their couch.

The COVID-19 pandemic has resulted in millions of deaths and trillions of dollars in economic loss, as well as changed the norms of social interaction. One of the many ways it impacted our health care system is through the exponential growth of telehealth – the use of telecommunication modalities, such as telephone and real-time video – to connect patients with clinicians for the purpose of providing health care.

Prior to the pandemic, telehealth was limited to populations with limited access to health care. Our practice had never performed telehealth, yet converted nearly exclusively to telehealth at the height of the pandemic. My colleagues and I were concerned about how patients and physicians would respond to the sudden disruption of norms of patient engagement.

To measure the response, we conducted an online survey of over 500 gastroenterologists and nearly 1,500 patients from March to May 2020 to assess their satisfaction with telehealth. Our published results demonstrated that more than 80% of patients and 90% of physicians surveyed were either satisfied or highly satisfied with telehealth. Surprisingly, these trends were true irrespective of age or the reason for a visit. Greater than 80% of patients also indicated that the provider addressed their concerns and that they were willing to participate in telehealth visits in the future.

In a subsequent survey of nearly 3,000 patients who had experience with telehealth and in-person visits, 73% of respondents indicated that they received a similar quality of care through telehealth as compared to in-person visits and 61% stated that the interaction with their physician was also similar. More than half of the patients (54%) were likely to continue using telehealth services after the pandemic mainly because of shorter wait and travel times (75%), flexibility with personal schedule (56%), and ease of scheduling appointments on a desired date (47%).

During the COVID-19 pandemic, access to health care has been limited for a great number of patients, and telehealth has been a useful and necessary tool in overcoming this challenge. Telehealth also promotes the triple aim of improving health care by improving the care experience, reducing cost, and improving patient and population health outcomes. Our findings showed a high level of overall patient and provider satisfaction following telehealth appointments. Telehealth increases access to care by decreasing travel time and cost, limiting missed workdays, and reducing the need to find alternative caregivers, especially among rural communities and people facing financial hardship. For a small subset of people who lack the resources, access to technology, or ability to do video visits, telephone-only visits are an appropriate option and should be preserved and reimbursed in some capacity.

From a patient perspective, convenience and decreased cost are often cited as major reasons for satisfaction with telehealth. This is of particular importance to people with limited mobility, nontraditional work hours, and lower socioeconomic status. For patients who use public transportation or caregivers to travel to appointments, a short appointment may require hours of logistical planning and may come at significant financial cost. Enabling these patients to interact with their providers from home would make accessing the health care system both less expensive and logistically less challenging.

One unexpected benefit of telehealth that I have experienced is the ability to “visit” the patients in their own surroundings. Many telehealth visits have allowed the doctor to make a “house call” and see the patients in their homes, cars, and break rooms. Observing the chaos in a home or an extremely quiet and dark space has given me insight into the role anxiety and depression might play in health conditions – which may have not been appreciated in a visit to my office.

The most memorable meeting was a man who was sitting in his kitchen while smoking a cigarette and drinking a beer for breakfast whose main complaint was heartburn. His life habits were obviously contributing to his heartburn, and this degree of insight would not have been appreciated during a traditional in-person office visit.

Congress is now contemplating the role telehealth will play in health care once the pandemic is over. The main concerns are abuse of telehealth by providers, leading to a dramatic rise in visits due to the ease of care delivery. This in turn can dramatically increase health care costs. The long-term health outcomes of patients seen through telehealth are also unknown and must be studied.

All these concerns are valid and must be addressed in future studies, but it would be a mistake for Congress to revert telehealth back to prepandemic regulations. We must move forward with this important innovation in care delivery.

The adoption of telehealth is one of few silver linings of the COVID-19 pandemic. It will never replace in-person visits but should be preserved as an additional tool we can use when in-person visits are not the best option. The future of U.S. health care must allow for a hybrid model so that patients and providers can continue to benefit from this valuable innovation. Patients, providers, and families will be forever grateful.
 

Naresh Gunaratnam MD, AGAF is a practicing gastroenterologist with Huron Gastroenterology in Ann Arbor, Mich. He also serves as the chair of data analytics as a member of the Digestive Health Physicians Association executive committee. Dr. Gunaratnam has no conflicts in telehealth. He is the founder of and CMO of a weight loss device company and service.

On March 11, 2020, the World Health Organization declared the novel coronavirus disease (COVID-19) to be a global pandemic. Shortly after, federal regulators temporarily relaxed restrictions, raised Medicare payment for telemedicine visits to the same level as in-person visits, and waived or reduced cost sharing for patients. As pandemic-related regulations expire, policymakers are debating the need to address insurance coverage of telemedicine services going forward. Congress should consider the lessons learned over the past 20 months to ensure that health care providers have the flexibility to meet the needs of patients.

One of my early telehealth visits was with a patient in his 80s who spent nearly a month in the hospital after complex abdominal surgery. While at home with his daughter, it was the first visit to assess his progress after discharge from the hospital. We were able to address his concerns, assess his wounds using the video on his computer, and formulate a plan so he could continue to improve. At the end of the call, his daughter mentioned in passing, “Thank God we did not have to go to the office ... that would have been a nightmare.”

The nightmare would have consisted of driving her frail father 45 minutes to our office, spending 15 minutes to park, waiting for 30 minutes to be seen, and finally speaking with the physician for 30 minutes face-to-face. Following the appointment, my patient and his daughter would spend another 10 minutes checking out before the 45-minute drive home. Instead, they spent a few minutes logging on through a computer prior to the 30-minute visit from the comfort of their couch.

The COVID-19 pandemic has resulted in millions of deaths and trillions of dollars in economic loss, as well as changed the norms of social interaction. One of the many ways it impacted our health care system is through the exponential growth of telehealth – the use of telecommunication modalities, such as telephone and real-time video – to connect patients with clinicians for the purpose of providing health care.

Prior to the pandemic, telehealth was limited to populations with limited access to health care. Our practice had never performed telehealth, yet converted nearly exclusively to telehealth at the height of the pandemic. My colleagues and I were concerned about how patients and physicians would respond to the sudden disruption of norms of patient engagement.

To measure the response, we conducted an online survey of over 500 gastroenterologists and nearly 1,500 patients from March to May 2020 to assess their satisfaction with telehealth. Our published results demonstrated that more than 80% of patients and 90% of physicians surveyed were either satisfied or highly satisfied with telehealth. Surprisingly, these trends were true irrespective of age or the reason for a visit. Greater than 80% of patients also indicated that the provider addressed their concerns and that they were willing to participate in telehealth visits in the future.

In a subsequent survey of nearly 3,000 patients who had experience with telehealth and in-person visits, 73% of respondents indicated that they received a similar quality of care through telehealth as compared to in-person visits and 61% stated that the interaction with their physician was also similar. More than half of the patients (54%) were likely to continue using telehealth services after the pandemic mainly because of shorter wait and travel times (75%), flexibility with personal schedule (56%), and ease of scheduling appointments on a desired date (47%).

During the COVID-19 pandemic, access to health care has been limited for a great number of patients, and telehealth has been a useful and necessary tool in overcoming this challenge. Telehealth also promotes the triple aim of improving health care by improving the care experience, reducing cost, and improving patient and population health outcomes. Our findings showed a high level of overall patient and provider satisfaction following telehealth appointments. Telehealth increases access to care by decreasing travel time and cost, limiting missed workdays, and reducing the need to find alternative caregivers, especially among rural communities and people facing financial hardship. For a small subset of people who lack the resources, access to technology, or ability to do video visits, telephone-only visits are an appropriate option and should be preserved and reimbursed in some capacity.

From a patient perspective, convenience and decreased cost are often cited as major reasons for satisfaction with telehealth. This is of particular importance to people with limited mobility, nontraditional work hours, and lower socioeconomic status. For patients who use public transportation or caregivers to travel to appointments, a short appointment may require hours of logistical planning and may come at significant financial cost. Enabling these patients to interact with their providers from home would make accessing the health care system both less expensive and logistically less challenging.

One unexpected benefit of telehealth that I have experienced is the ability to “visit” the patients in their own surroundings. Many telehealth visits have allowed the doctor to make a “house call” and see the patients in their homes, cars, and break rooms. Observing the chaos in a home or an extremely quiet and dark space has given me insight into the role anxiety and depression might play in health conditions – which may have not been appreciated in a visit to my office.

The most memorable meeting was a man who was sitting in his kitchen while smoking a cigarette and drinking a beer for breakfast whose main complaint was heartburn. His life habits were obviously contributing to his heartburn, and this degree of insight would not have been appreciated during a traditional in-person office visit.

Congress is now contemplating the role telehealth will play in health care once the pandemic is over. The main concerns are abuse of telehealth by providers, leading to a dramatic rise in visits due to the ease of care delivery. This in turn can dramatically increase health care costs. The long-term health outcomes of patients seen through telehealth are also unknown and must be studied.

All these concerns are valid and must be addressed in future studies, but it would be a mistake for Congress to revert telehealth back to prepandemic regulations. We must move forward with this important innovation in care delivery.

The adoption of telehealth is one of few silver linings of the COVID-19 pandemic. It will never replace in-person visits but should be preserved as an additional tool we can use when in-person visits are not the best option. The future of U.S. health care must allow for a hybrid model so that patients and providers can continue to benefit from this valuable innovation. Patients, providers, and families will be forever grateful.
 

Naresh Gunaratnam MD, AGAF is a practicing gastroenterologist with Huron Gastroenterology in Ann Arbor, Mich. He also serves as the chair of data analytics as a member of the Digestive Health Physicians Association executive committee. Dr. Gunaratnam has no conflicts in telehealth. He is the founder of and CMO of a weight loss device company and service.