Lisa Nainggolan

The past week has seen heated debate about the complex issue of how to best treat children with gender dysphoria, with further developments in a number of U.S. states and in Sweden. 

In the U.S., more states have moved to prevent the use of any medical treatment, such as puberty blockers or cross-sex hormones, in kids younger than the age of 18, most recently in a state Senate vote in Alabama last week, and in Texas, where Governor Greg Abbott is said to have ordered state agencies to investigate reports of gender-transition procedures on children as “child abuse.”

At least one parent has, because of this, established a crowdfunding page to try to raise money to move away from Texas, fearful of being accused of child abuse if their child with gender dysphoria receives hormone therapy. And a countersuit has been filed there by the ACLU of Texas and Lambda Legal, a civil rights organization, on behalf of one parent said to be under investigation.

But on the flip side, parents living in more liberal states – where children under the age of 18 can often get hormones to transition without parental consent – are considering moving out of them to protect their children. These parents are concerned that their kids do not know enough about the side effects of puberty blockers, or lifetime use of cross-sex hormones and its implications, to be able to make properly informed decisions at such a young age.  

Meanwhile, Sweden has further tightened its restrictions on medical therapy to treat gender-questioning kids, with a recent announcement from its National Board of Health and Welfare (NBHW), on Feb. 22, urging restraint in hormone treatment of minors with gender dysphoria following a review by the agency there that assesses health technologies, the SBU.

Based on the review results, the NBHW’s overall conclusion is that the risks of puberty blocking and cross-sex hormone treatment for those under 18 currently outweigh the possible benefits for the group as a whole. The agency now says hormone treatment should only be offered in exceptional cases outside the framework of research, and principally, only in adolescents with childhood-onset gender dysphoria, as opposed to those who develop it during puberty, or in their teens, as is the case with most teenagers currently presenting. 

At the same time, gender-affirming hormone treatment for adolescents who identify as transgender or nonbinary is associated with changes in depression and suicidality, according to a new U.S. survey published Feb. 25 in JAMA Network Health. 

However, experts who spoke to this news organization were critical of the study, noting it was small, conducted in just 104 youth who were an average age of 15.8 years and of whom only 63% completed the survey at the final timepoint, just 1 year after starting therapy. In addition, there was no control group, among other limitations.

“The most worrying thing is that they haven’t described the pros and cons of the treatment that they are researching. We know that there are risks inherent in using gender-affirming medicine, as with all medications,” Anna Hutchinson, DClinPsych, of the Integrated Psychology Clinic, London, told this news organization.

“For example, when people with gender dysphoria use cross-sex hormones, there is a burden of treatment that can last a lifetime, both for those who benefit from the treatment and those who detransition or regret later on,” said Dr. Hutchinson, who has extensive experience of working with young people with issues related to sexuality or gender.

“This isn’t mentioned at all, which makes the paper appear quite biased towards using one approach for managing gender dysphoria and related distress, whilst not acknowledging any risks of doing so or considering alternatives,” she noted.
 

Why were some treated with hormones while others weren’t? 

The newly published survey is by PhD student Diana M. Tordoff, MPH, of the Department of Epidemiology, University of Washington, Seattle, and colleagues. Published alongside was an invited commentary by Brett Dolotina, BS, of Massachusetts General Hospital, Boston, and Jack L. Turban, MD, MHS, of Stanford (Calif.) University.

The study was conducted at an urban multidisciplinary gender clinic in Seattle among transgender and nonbinary adolescents and young adults seeking gender-affirming care from August 2017 to June 2018. Data were analyzed from August 2020 to November 2021.

Participating in the study were 104 youths aged 13-20 years (mean age, 15.8 years), 63 transmasculine (born female) individuals (60.6%), 27 transfeminine (born male) individuals (26.0%), 10 nonbinary or gender-fluid individuals (9.6%), and four youths who responded, “I don’t know,” or did not respond to the gender-identity question (3.8%). 

At baseline, 59 individuals (56.7%) had moderate-to-severe depression, 52 individuals (50.0%) had moderate-to-severe anxiety, and 45 individuals (43.3%) reported self-harm or suicidal thoughts. 

By the end of the study, 69 youths (66.3%) had received puberty blockers, cross-sex hormones (testosterone for girls transitioning to male and estrogen for boys transitioning to female), or both interventions, while 35 youths had not received either intervention (33.7%). 

After adjustment for temporal trends and potential confounders, there were a 60% lower odds of depression (adjusted odds ratio, 0.40; 95% confidence interval, 0.17-0.95) and 73% lower odds of suicidality (aOR, 0.27; 95% CI, 0.11-0.65) among youths who had initiated puberty blockers or cross-sex hormones. 

There was no association between these treatments and anxiety, however (aOR, 1.01; 95% CI, 0.41-2.51).

Dr. Hutchinson points out that nonbinary and gender fluid “are not diagnostic or clinical terms,” adding, “there is no information about how the groups were chosen or if any of them met the criteria for gender dysphoria. It seems strange to not have measured gender dysphoria, both before and after interventions, in a group of children presenting with gender dysphoria.”

She adds: “I am questioning why ‘gender-affirming’ medicine appears to be being used here as a specific intervention for depression and suicidality? [That] wouldn’t usually be the first reason to commence these particular treatments. Why didn’t they provide therapy or antidepressant medication to this group of young people, as is routine for managing mood and/or suicidality in all other patient cohorts?”  

In their commentary, Mr. Dolotina and Dr. Turban observe: “The rate of suicidality among the Tordoff et al. sample after receiving gender-affirming care was still much higher than national rates of suicidality among youth in the U.S., denoting that ... other mental health determinants must be addressed ... including gender minority stress.”
 

Small study, no control group, large loss to follow-up

Dr. Hutchinson also criticizes the small sample size of just 104 youth and “large loss to follow-up, whereby only 65 of those 104 [youth] completed the final survey in a short time [1 year].” This could indicate “that only the most satisfied kids stayed the course,” she suggests. 

And importantly, the findings on depression and suicidality rely on the experience of only five people in the no-treatment group at 12 months, she points out. 

Also, as the authors themselves acknowledge, they didn’t control for other psychiatric medicines that the participants might have been taking at baseline.

“It’s important to know more about all of this in order to draw accurate conclusions about what works, or does not, for whom,” noted Dr. Hutchinson.

Most patients, too, she notes, were females-to-males taking testosterone. Therefore, the finding that they experienced a reduction in depression might simply reflect the widely reported antidepressant effects of testosterone. 

Also expressing concern about the small sample size and “lack of a control group” is Michelle Mackness, MC, a Canadian counselor in private practice who has experience working with gender-questioning individuals, detransitioners, and those experiencing complications related to their transition. 

“Tordoff et al.’s assertion that there is a ‘robust evidence base’ supporting pediatric transition seems out-of-step with recent global developments in care policies and protocols for gender-questioning youth,” she points out.

“Neither the study authors or commentators acknowledge, let alone address, the fact that Finland, the U.K., and Sweden have recently determined that the evidence allegedly supporting medical interventions for pediatric transition is ‘inconclusive’,” she adds. 

Asked to respond, Ms. Tordoff did not directly address this question. Rather, she reiterated to this news organization: “We found that receipt of puberty blockers and gender-affirming hormones was associated with a 60% lower odds of depression and a 73% lower odds of suicidal thoughts by the end of our study follow-up. We conducted extensive sensitivity analyses, which support the robustness of our study findings.”

She added: “These results are consistent with other recently published prospective cohort studies (please see citations provided within the manuscript).”

Parents may move states

It is this concern about the lifetime burden of treatment involved with transitioning that gives some parents of children with gender dysphoria pause for thought, especially those who live in more liberal U.S. states.

Indeed, two of America’s leading psychologists who work in this field, including one who is transgender herself, told this news organization in November they are now concerned about a lack of adequate psychological evaluations of youth with gender dysphoria before any medical treatment is considered. 

So while one parent, Violet A., last week established a GoFundMe page for her child, entitled, “Help Us Move Isa to Safety,” stating she needed to move from Texas due to Governor Abbott’s pronouncements there “to a state that won’t consider me an abuser when I seek medical care for my trans child and potentially remove her from my custody,” some parents feel the need instead to move from more liberal states.

Some tell their stories anonymously, as they don’t want to risk causing their gender-questioning children further distress, as detailed on the Genspect website.

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

The past week has seen heated debate about the complex issue of how to best treat children with gender dysphoria, with further developments in a number of U.S. states and in Sweden. 

In the U.S., more states have moved to prevent the use of any medical treatment, such as puberty blockers or cross-sex hormones, in kids younger than the age of 18, most recently in a state Senate vote in Alabama last week, and in Texas, where Governor Greg Abbott is said to have ordered state agencies to investigate reports of gender-transition procedures on children as “child abuse.”

At least one parent has, because of this, established a crowdfunding page to try to raise money to move away from Texas, fearful of being accused of child abuse if their child with gender dysphoria receives hormone therapy. And a countersuit has been filed there by the ACLU of Texas and Lambda Legal, a civil rights organization, on behalf of one parent said to be under investigation.

But on the flip side, parents living in more liberal states – where children under the age of 18 can often get hormones to transition without parental consent – are considering moving out of them to protect their children. These parents are concerned that their kids do not know enough about the side effects of puberty blockers, or lifetime use of cross-sex hormones and its implications, to be able to make properly informed decisions at such a young age.  

Meanwhile, Sweden has further tightened its restrictions on medical therapy to treat gender-questioning kids, with a recent announcement from its National Board of Health and Welfare (NBHW), on Feb. 22, urging restraint in hormone treatment of minors with gender dysphoria following a review by the agency there that assesses health technologies, the SBU.

Based on the review results, the NBHW’s overall conclusion is that the risks of puberty blocking and cross-sex hormone treatment for those under 18 currently outweigh the possible benefits for the group as a whole. The agency now says hormone treatment should only be offered in exceptional cases outside the framework of research, and principally, only in adolescents with childhood-onset gender dysphoria, as opposed to those who develop it during puberty, or in their teens, as is the case with most teenagers currently presenting. 

At the same time, gender-affirming hormone treatment for adolescents who identify as transgender or nonbinary is associated with changes in depression and suicidality, according to a new U.S. survey published Feb. 25 in JAMA Network Health. 

However, experts who spoke to this news organization were critical of the study, noting it was small, conducted in just 104 youth who were an average age of 15.8 years and of whom only 63% completed the survey at the final timepoint, just 1 year after starting therapy. In addition, there was no control group, among other limitations.

“The most worrying thing is that they haven’t described the pros and cons of the treatment that they are researching. We know that there are risks inherent in using gender-affirming medicine, as with all medications,” Anna Hutchinson, DClinPsych, of the Integrated Psychology Clinic, London, told this news organization.

“For example, when people with gender dysphoria use cross-sex hormones, there is a burden of treatment that can last a lifetime, both for those who benefit from the treatment and those who detransition or regret later on,” said Dr. Hutchinson, who has extensive experience of working with young people with issues related to sexuality or gender.

“This isn’t mentioned at all, which makes the paper appear quite biased towards using one approach for managing gender dysphoria and related distress, whilst not acknowledging any risks of doing so or considering alternatives,” she noted.
 

Why were some treated with hormones while others weren’t? 

The newly published survey is by PhD student Diana M. Tordoff, MPH, of the Department of Epidemiology, University of Washington, Seattle, and colleagues. Published alongside was an invited commentary by Brett Dolotina, BS, of Massachusetts General Hospital, Boston, and Jack L. Turban, MD, MHS, of Stanford (Calif.) University.

The study was conducted at an urban multidisciplinary gender clinic in Seattle among transgender and nonbinary adolescents and young adults seeking gender-affirming care from August 2017 to June 2018. Data were analyzed from August 2020 to November 2021.

Participating in the study were 104 youths aged 13-20 years (mean age, 15.8 years), 63 transmasculine (born female) individuals (60.6%), 27 transfeminine (born male) individuals (26.0%), 10 nonbinary or gender-fluid individuals (9.6%), and four youths who responded, “I don’t know,” or did not respond to the gender-identity question (3.8%). 

At baseline, 59 individuals (56.7%) had moderate-to-severe depression, 52 individuals (50.0%) had moderate-to-severe anxiety, and 45 individuals (43.3%) reported self-harm or suicidal thoughts. 

By the end of the study, 69 youths (66.3%) had received puberty blockers, cross-sex hormones (testosterone for girls transitioning to male and estrogen for boys transitioning to female), or both interventions, while 35 youths had not received either intervention (33.7%). 

After adjustment for temporal trends and potential confounders, there were a 60% lower odds of depression (adjusted odds ratio, 0.40; 95% confidence interval, 0.17-0.95) and 73% lower odds of suicidality (aOR, 0.27; 95% CI, 0.11-0.65) among youths who had initiated puberty blockers or cross-sex hormones. 

There was no association between these treatments and anxiety, however (aOR, 1.01; 95% CI, 0.41-2.51).

Dr. Hutchinson points out that nonbinary and gender fluid “are not diagnostic or clinical terms,” adding, “there is no information about how the groups were chosen or if any of them met the criteria for gender dysphoria. It seems strange to not have measured gender dysphoria, both before and after interventions, in a group of children presenting with gender dysphoria.”

She adds: “I am questioning why ‘gender-affirming’ medicine appears to be being used here as a specific intervention for depression and suicidality? [That] wouldn’t usually be the first reason to commence these particular treatments. Why didn’t they provide therapy or antidepressant medication to this group of young people, as is routine for managing mood and/or suicidality in all other patient cohorts?”  

In their commentary, Mr. Dolotina and Dr. Turban observe: “The rate of suicidality among the Tordoff et al. sample after receiving gender-affirming care was still much higher than national rates of suicidality among youth in the U.S., denoting that ... other mental health determinants must be addressed ... including gender minority stress.”
 

Small study, no control group, large loss to follow-up

Dr. Hutchinson also criticizes the small sample size of just 104 youth and “large loss to follow-up, whereby only 65 of those 104 [youth] completed the final survey in a short time [1 year].” This could indicate “that only the most satisfied kids stayed the course,” she suggests. 

And importantly, the findings on depression and suicidality rely on the experience of only five people in the no-treatment group at 12 months, she points out. 

Also, as the authors themselves acknowledge, they didn’t control for other psychiatric medicines that the participants might have been taking at baseline.

“It’s important to know more about all of this in order to draw accurate conclusions about what works, or does not, for whom,” noted Dr. Hutchinson.

Most patients, too, she notes, were females-to-males taking testosterone. Therefore, the finding that they experienced a reduction in depression might simply reflect the widely reported antidepressant effects of testosterone. 

Also expressing concern about the small sample size and “lack of a control group” is Michelle Mackness, MC, a Canadian counselor in private practice who has experience working with gender-questioning individuals, detransitioners, and those experiencing complications related to their transition. 

“Tordoff et al.’s assertion that there is a ‘robust evidence base’ supporting pediatric transition seems out-of-step with recent global developments in care policies and protocols for gender-questioning youth,” she points out.

“Neither the study authors or commentators acknowledge, let alone address, the fact that Finland, the U.K., and Sweden have recently determined that the evidence allegedly supporting medical interventions for pediatric transition is ‘inconclusive’,” she adds. 

Asked to respond, Ms. Tordoff did not directly address this question. Rather, she reiterated to this news organization: “We found that receipt of puberty blockers and gender-affirming hormones was associated with a 60% lower odds of depression and a 73% lower odds of suicidal thoughts by the end of our study follow-up. We conducted extensive sensitivity analyses, which support the robustness of our study findings.”

She added: “These results are consistent with other recently published prospective cohort studies (please see citations provided within the manuscript).”

Parents may move states

It is this concern about the lifetime burden of treatment involved with transitioning that gives some parents of children with gender dysphoria pause for thought, especially those who live in more liberal U.S. states.

Indeed, two of America’s leading psychologists who work in this field, including one who is transgender herself, told this news organization in November they are now concerned about a lack of adequate psychological evaluations of youth with gender dysphoria before any medical treatment is considered. 

So while one parent, Violet A., last week established a GoFundMe page for her child, entitled, “Help Us Move Isa to Safety,” stating she needed to move from Texas due to Governor Abbott’s pronouncements there “to a state that won’t consider me an abuser when I seek medical care for my trans child and potentially remove her from my custody,” some parents feel the need instead to move from more liberal states.

Some tell their stories anonymously, as they don’t want to risk causing their gender-questioning children further distress, as detailed on the Genspect website.

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

The past week has seen heated debate about the complex issue of how to best treat children with gender dysphoria, with further developments in a number of U.S. states and in Sweden. 

In the U.S., more states have moved to prevent the use of any medical treatment, such as puberty blockers or cross-sex hormones, in kids younger than the age of 18, most recently in a state Senate vote in Alabama last week, and in Texas, where Governor Greg Abbott is said to have ordered state agencies to investigate reports of gender-transition procedures on children as “child abuse.”

At least one parent has, because of this, established a crowdfunding page to try to raise money to move away from Texas, fearful of being accused of child abuse if their child with gender dysphoria receives hormone therapy. And a countersuit has been filed there by the ACLU of Texas and Lambda Legal, a civil rights organization, on behalf of one parent said to be under investigation.

But on the flip side, parents living in more liberal states – where children under the age of 18 can often get hormones to transition without parental consent – are considering moving out of them to protect their children. These parents are concerned that their kids do not know enough about the side effects of puberty blockers, or lifetime use of cross-sex hormones and its implications, to be able to make properly informed decisions at such a young age.  

Meanwhile, Sweden has further tightened its restrictions on medical therapy to treat gender-questioning kids, with a recent announcement from its National Board of Health and Welfare (NBHW), on Feb. 22, urging restraint in hormone treatment of minors with gender dysphoria following a review by the agency there that assesses health technologies, the SBU.

Based on the review results, the NBHW’s overall conclusion is that the risks of puberty blocking and cross-sex hormone treatment for those under 18 currently outweigh the possible benefits for the group as a whole. The agency now says hormone treatment should only be offered in exceptional cases outside the framework of research, and principally, only in adolescents with childhood-onset gender dysphoria, as opposed to those who develop it during puberty, or in their teens, as is the case with most teenagers currently presenting. 

At the same time, gender-affirming hormone treatment for adolescents who identify as transgender or nonbinary is associated with changes in depression and suicidality, according to a new U.S. survey published Feb. 25 in JAMA Network Health. 

However, experts who spoke to this news organization were critical of the study, noting it was small, conducted in just 104 youth who were an average age of 15.8 years and of whom only 63% completed the survey at the final timepoint, just 1 year after starting therapy. In addition, there was no control group, among other limitations.

“The most worrying thing is that they haven’t described the pros and cons of the treatment that they are researching. We know that there are risks inherent in using gender-affirming medicine, as with all medications,” Anna Hutchinson, DClinPsych, of the Integrated Psychology Clinic, London, told this news organization.

“For example, when people with gender dysphoria use cross-sex hormones, there is a burden of treatment that can last a lifetime, both for those who benefit from the treatment and those who detransition or regret later on,” said Dr. Hutchinson, who has extensive experience of working with young people with issues related to sexuality or gender.

“This isn’t mentioned at all, which makes the paper appear quite biased towards using one approach for managing gender dysphoria and related distress, whilst not acknowledging any risks of doing so or considering alternatives,” she noted.
 

Why were some treated with hormones while others weren’t? 

The newly published survey is by PhD student Diana M. Tordoff, MPH, of the Department of Epidemiology, University of Washington, Seattle, and colleagues. Published alongside was an invited commentary by Brett Dolotina, BS, of Massachusetts General Hospital, Boston, and Jack L. Turban, MD, MHS, of Stanford (Calif.) University.

The study was conducted at an urban multidisciplinary gender clinic in Seattle among transgender and nonbinary adolescents and young adults seeking gender-affirming care from August 2017 to June 2018. Data were analyzed from August 2020 to November 2021.

Participating in the study were 104 youths aged 13-20 years (mean age, 15.8 years), 63 transmasculine (born female) individuals (60.6%), 27 transfeminine (born male) individuals (26.0%), 10 nonbinary or gender-fluid individuals (9.6%), and four youths who responded, “I don’t know,” or did not respond to the gender-identity question (3.8%). 

At baseline, 59 individuals (56.7%) had moderate-to-severe depression, 52 individuals (50.0%) had moderate-to-severe anxiety, and 45 individuals (43.3%) reported self-harm or suicidal thoughts. 

By the end of the study, 69 youths (66.3%) had received puberty blockers, cross-sex hormones (testosterone for girls transitioning to male and estrogen for boys transitioning to female), or both interventions, while 35 youths had not received either intervention (33.7%). 

After adjustment for temporal trends and potential confounders, there were a 60% lower odds of depression (adjusted odds ratio, 0.40; 95% confidence interval, 0.17-0.95) and 73% lower odds of suicidality (aOR, 0.27; 95% CI, 0.11-0.65) among youths who had initiated puberty blockers or cross-sex hormones. 

There was no association between these treatments and anxiety, however (aOR, 1.01; 95% CI, 0.41-2.51).

Dr. Hutchinson points out that nonbinary and gender fluid “are not diagnostic or clinical terms,” adding, “there is no information about how the groups were chosen or if any of them met the criteria for gender dysphoria. It seems strange to not have measured gender dysphoria, both before and after interventions, in a group of children presenting with gender dysphoria.”

She adds: “I am questioning why ‘gender-affirming’ medicine appears to be being used here as a specific intervention for depression and suicidality? [That] wouldn’t usually be the first reason to commence these particular treatments. Why didn’t they provide therapy or antidepressant medication to this group of young people, as is routine for managing mood and/or suicidality in all other patient cohorts?”  

In their commentary, Mr. Dolotina and Dr. Turban observe: “The rate of suicidality among the Tordoff et al. sample after receiving gender-affirming care was still much higher than national rates of suicidality among youth in the U.S., denoting that ... other mental health determinants must be addressed ... including gender minority stress.”
 

Small study, no control group, large loss to follow-up

Dr. Hutchinson also criticizes the small sample size of just 104 youth and “large loss to follow-up, whereby only 65 of those 104 [youth] completed the final survey in a short time [1 year].” This could indicate “that only the most satisfied kids stayed the course,” she suggests. 

And importantly, the findings on depression and suicidality rely on the experience of only five people in the no-treatment group at 12 months, she points out. 

Also, as the authors themselves acknowledge, they didn’t control for other psychiatric medicines that the participants might have been taking at baseline.

“It’s important to know more about all of this in order to draw accurate conclusions about what works, or does not, for whom,” noted Dr. Hutchinson.

Most patients, too, she notes, were females-to-males taking testosterone. Therefore, the finding that they experienced a reduction in depression might simply reflect the widely reported antidepressant effects of testosterone. 

Also expressing concern about the small sample size and “lack of a control group” is Michelle Mackness, MC, a Canadian counselor in private practice who has experience working with gender-questioning individuals, detransitioners, and those experiencing complications related to their transition. 

“Tordoff et al.’s assertion that there is a ‘robust evidence base’ supporting pediatric transition seems out-of-step with recent global developments in care policies and protocols for gender-questioning youth,” she points out.

“Neither the study authors or commentators acknowledge, let alone address, the fact that Finland, the U.K., and Sweden have recently determined that the evidence allegedly supporting medical interventions for pediatric transition is ‘inconclusive’,” she adds. 

Asked to respond, Ms. Tordoff did not directly address this question. Rather, she reiterated to this news organization: “We found that receipt of puberty blockers and gender-affirming hormones was associated with a 60% lower odds of depression and a 73% lower odds of suicidal thoughts by the end of our study follow-up. We conducted extensive sensitivity analyses, which support the robustness of our study findings.”

She added: “These results are consistent with other recently published prospective cohort studies (please see citations provided within the manuscript).”

Parents may move states

It is this concern about the lifetime burden of treatment involved with transitioning that gives some parents of children with gender dysphoria pause for thought, especially those who live in more liberal U.S. states.

Indeed, two of America’s leading psychologists who work in this field, including one who is transgender herself, told this news organization in November they are now concerned about a lack of adequate psychological evaluations of youth with gender dysphoria before any medical treatment is considered. 

So while one parent, Violet A., last week established a GoFundMe page for her child, entitled, “Help Us Move Isa to Safety,” stating she needed to move from Texas due to Governor Abbott’s pronouncements there “to a state that won’t consider me an abuser when I seek medical care for my trans child and potentially remove her from my custody,” some parents feel the need instead to move from more liberal states.

Some tell their stories anonymously, as they don’t want to risk causing their gender-questioning children further distress, as detailed on the Genspect website.

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

Media coverage of transgender health care judged to be “negative” was associated with a drop of around 30% in referral rates to gender identity clinics in Sweden among young people under age 19, a new study indicates.

Malin Indremo, MS, from the department of neuroscience, Uppsala (Sweden) University, and colleagues explored the effect of the documentaries, “The Trans Train and Teenage Girls,” which they explain was a “Swedish public service television show” representing “investigative journalism.” The two-part documentary series was aired in Sweden in April 2019 and October 2019, respectively, and is now available in English on YouTube.

In their article, published online in JAMA Network Open, the authors said they consider “The Trans Train” programs to be “negative” media coverage because the “documentaries addressed the distinct increase among adolescents referred to gender identity clinics in recent years. Two young adults who regretted their transition and parents of transgender individuals who questioned the clinics’ assessments of their children were interviewed, and concerns were raised about whether gender-confirming treatments are based on sufficient scientific evidence.”

The programs, they suggest, may have influenced and jeopardized young transgender individuals’ access to transgender-specific health care.

Stella O’Malley, a U.K.-based psychotherapist specializing in transgender care and executive director of Genspect, an international organization that provides support to the parents of young people who are questioning their gender, expressed her disappointment with the study’s conclusions.

“I’m really surprised and disappointed that the researchers believe that negative coverage is the reason for a drop in referrals when it is more accurate to say that the information provided by ‘The Trans Train’ documentaries was concerning and suggests that further critical analysis and a review needs to be carried out on the clinics in question,” she said in an interview.

Ms. O’Malley herself made a documentary for Channel 4 in the United Kingdom, broadcast in 2018, called: “Trans Kids: It’s Time to Talk.”
 

Rapidly increasing numbers of youth, especially girls, question gender

As Ms. Indremo and coauthors explained – and as has been widely reported by this news organization – “the number of referrals to gender identity clinics have rapidly increased worldwide” in recent years, and this “has been especially prominent in adolescents and young adults.”

In addition, they acknowledged, “there has been a shift in gender ratio, with a preponderance toward individuals who were assigned female at birth (AFAB).”

This was the topic of “The Trans Train” programs, and in fact, following their broadcast, Ms. Indremo and colleagues noted that “an intense debate in national media [in Sweden] arose from the documentaries.”

Their research aimed to explore the association between both “positive” and “negative” media coverage and the number of referrals to gender identity clinics for young people (under aged 19) respectively. Data from the six gender clinics in Sweden were included between January 2017 and December 2019.

In the period studied, the clinics received 1,784 referrals, including 613 referrals in 2017, 663 referrals in 2018, and 508 referrals in 2019.

From the age-specific data that included 1,674 referrals, 359 individuals (21.4%) were younger than 13 years and 1,315 individuals (78.6%) were aged 13-18 years. From the assigned sex-specific data that included 1,435 referrals, 1,034 individuals (72.1%) were AFAB and 401 individuals (27.9%) were assigned male at birth (AMAB). Information on sex assigned at birth was lacking from one clinic, which was excluded from the analysis.

When they examined data for the 3 months following the airing of the first part of “The Trans Train” documentary series (in April 2019), they found that referrals to gender clinics fell by 25.4% overall, compared with the 3 months before part 1 was screened. Specifically, they fell by 25.3% for young people aged 13-18 years and by 32.2% for those born female.

In the extended analyses of 6 months following part 1, a decrease of total referrals by 30.7% was observed, while referrals for AFAB individuals decreased by 37.4% and referrals for individuals aged 13-18 years decreased by 27.7%. A decrease of referrals by 41.7% for children aged younger than 13 years was observed in the 6-month analysis, as well as a decrease of 8.2% among AMAB individuals.

“The Trans Train” documentaries, Ms. Indremo and colleagues said, “were criticized for being negatively biased and giving an oversimplified picture of transgender health care.”
 

Did the nature of the trans train documentaries influence referrals?

In an invited commentary published in JAMA Network Open, Ken C. Pang, PhD, from the Murdoch Children’s Research Institute, Melbourne, and colleagues noted: “Although the mechanisms underlying this decrease [in referrals] were not formally explored in their study, the authors reasonably speculated that both parents and referring health professionals may have been less likely to support a child or adolescent’s attendance at a specialist pediatric gender clinic following the documentaries.”

Dr. Pang and colleagues went on to say it is “the ... responsibility of media organizations in ensuring that stories depicting health care for transgender and gender diverse (TGD) young people are fair, balanced, nuanced, and accurate.”

Often, media reports have “fallen short of these standards and lacked the voices of TGD young people who have benefited from gender-affirming care or the perspectives of health professionals with expertise in providing such care,” they added.

“For example, some [media reports] have suggested that the growing number of referrals to such clinics is not owing to greater awareness of gender diversity and empowerment of TGD young people but is instead being driven by other factors such as peer influence, while others have warned that the use of gender-affirming hormonal interventions in TGD young people represents an undue risk,” they continue.

Ms. Indremo and colleagues didn’t see any drop-in referrals after the second part of the series, aired in October 2019, but they say this was likely because referrals were “already lowered” by the airing of the first part of the documentaries.

Nor did they see an increase in referrals following what they say was a “positive” media event in the form of a story about a professional Swedish handball player who announced the decision to quit his career to seek care for gender dysphoria.

“One may assume that a single news event is not significant enough to influence referral counts,” they suggested, noting also that Sweden represents “a society where there is already a relatively high level of awareness of gender identity issues.”

“Our results point to a differential association of media attention depending on the tone of the media content,” they observed.

Dr. Pang and coauthors noted it would be “helpful to examine whether similar media coverage in other countries has been associated with similar decreases in referral numbers and whether particular types of media stories are more prone to having this association.”
 

Parents and doctors debate treatment of gender dysphoria

In Sweden, custodians’ permission as well as custodians’ help is needed for minors to access care for gender dysphoria, said Ms. Indremo and coauthors. “It is possible that the content of the documentaries contributed to a higher custodian barrier to having their children referred for assessment, believing it may not be in the best interest of their child. This would highly impact young transgender individuals’ possibilities to access care.” 

They also acknowledge that health care practitioners who refer young people to specialist clinics might also have been influenced by the documentaries, noting “some commentators argued that all treatments for gender dysphoria be stopped, and that ‘all health care given at the gender identity clinics was an experiment lacking scientific basis.’ ”

In April 2021, Angela Sämfjord, MD, child and adolescent psychiatrist at Sahlgrenska University Hospital, Gothenburg, Sweden, who started a child and adolescent clinic – the Lundstrom Gender Clinic – told this news organization she had reevaluated her approach even prior to “The Trans Train” documentaries and had resigned in 2018 because of her own fears about the lack of evidence for hormonal and surgical treatments of youth with gender dysphoria.

Following the debate that ensued after the airing of “The Trans Train” programs, the Swedish National Board of Health and Welfare published new recommendations in March 2021, which reflected a significant change in direction for the evaluation of gender dysphoria in minors, emphasizing the requirement for a thorough mental health assessment.

And in May 2021, Karolinska Children’s Hospital, which houses one of the leading gender identity clinics in Sweden, announced it would stop the routine medical treatment of children with gender dysphoria under the age of 18, which meant a total ban on the prescribing of puberty blockers and cross-sex hormones to minors. Such treatment could henceforth only be carried out within the setting of a clinical trial approved by the EPM (Ethical Review Agency/Swedish Institutional Review Board), it said.

The remaining five gender identity clinics in Sweden decided upon their own rules, but in general, they have become much more cautious regarding medical treatment of minors within the past year. Also, there is a desire in Sweden to reduce the number of gender identity clinics for minors from the current six to perhaps a maximum of three nationwide.

However, neither Ms. Indremo and colleagues nor Dr. Pang and colleagues mentioned the subsequent change to the Swedish NBHW recommendations on evaluation of gender dysphoria in minors in JAMA articles.

New NBHW recommendations about medical treatment of gender dysphoria with puberty blockers and cross-sex hormones for minors were due to be issued in 2021 but have been delayed.
 

Debate in other countries

Sweden is not alone in discussing this issue. In 2020, Finland became the first country in the world to issue new guidelines that concluded there is a lack of quality evidence to support the use of hormonal interventions in adolescents with gender dysphoria.

This issue has been hotly debated in the United Kingdom – not least with the Keira Bell court case and two National Institute for Health and Clinical Excellence evidence reviews concluding there is a lack of data to support the use of puberty-blocking agents and “cross-sex” hormones in youth with gender dysphoria.

And a number of U.S. states are attempting to outlaw the medical and surgical treatment of gender dysphoria in minors. Even health care professionals who have been treating young people with gender dysphoria for years – some of whom are transgender themselves – have started to speak out and are questioning what they call “sloppy care” given to many such youth.

Indeed, a recent survey shows that detransitioners – individuals who suffer from gender dysphoria, transition to the opposite sex but then regret their decision and detransition – are getting short shrift when it comes to care, with over half of the 100 surveyed saying they feel they did not receive adequate evaluation from a doctor or mental health professional before starting to transition.

And new draft standards of care for treating people with gender dysphoria by the World Professional Association for Transgender Health have drawn criticism from experts.
 

‘First do no harm’

In their conclusion, Dr. Pang and coauthors said that, with respect to the media coverage of young people with gender dysphoria, “who are, after all, one of the most vulnerable subgroups within our society, perhaps our media should recall one of the core tenets of health care and ensure their stories ‘first, do no harm.’”

However, in a commentary recently published in Child and Adolescent Mental Health, Alison Clayton, MBBS, from the University of Melbourne, and coauthors again pointed out that evidence reviews of the use of puberty blockers in young people with gender dysphoria show “there is very low certainty of the benefits of puberty blockers, an unknown risk of harm, and there is need for more rigorous research.”

“The clinically prudent thing to do, if we aim to ‘first, do no harm,’ is to proceed with extreme caution, especially given the rapidly rising case numbers and novel gender dysphoria presentations,” Clayton and colleagues concluded.

Ms. Indremo and coauthors reported no relevant financial relationships. Dr. Pang reported being a member of the Australian Professional Association for Trans Health and its research committee. One commentary coauthor has reported being a member of WPATH.

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

Media coverage of transgender health care judged to be “negative” was associated with a drop of around 30% in referral rates to gender identity clinics in Sweden among young people under age 19, a new study indicates.

Malin Indremo, MS, from the department of neuroscience, Uppsala (Sweden) University, and colleagues explored the effect of the documentaries, “The Trans Train and Teenage Girls,” which they explain was a “Swedish public service television show” representing “investigative journalism.” The two-part documentary series was aired in Sweden in April 2019 and October 2019, respectively, and is now available in English on YouTube.

In their article, published online in JAMA Network Open, the authors said they consider “The Trans Train” programs to be “negative” media coverage because the “documentaries addressed the distinct increase among adolescents referred to gender identity clinics in recent years. Two young adults who regretted their transition and parents of transgender individuals who questioned the clinics’ assessments of their children were interviewed, and concerns were raised about whether gender-confirming treatments are based on sufficient scientific evidence.”

The programs, they suggest, may have influenced and jeopardized young transgender individuals’ access to transgender-specific health care.

Stella O’Malley, a U.K.-based psychotherapist specializing in transgender care and executive director of Genspect, an international organization that provides support to the parents of young people who are questioning their gender, expressed her disappointment with the study’s conclusions.

“I’m really surprised and disappointed that the researchers believe that negative coverage is the reason for a drop in referrals when it is more accurate to say that the information provided by ‘The Trans Train’ documentaries was concerning and suggests that further critical analysis and a review needs to be carried out on the clinics in question,” she said in an interview.

Ms. O’Malley herself made a documentary for Channel 4 in the United Kingdom, broadcast in 2018, called: “Trans Kids: It’s Time to Talk.”
 

Rapidly increasing numbers of youth, especially girls, question gender

As Ms. Indremo and coauthors explained – and as has been widely reported by this news organization – “the number of referrals to gender identity clinics have rapidly increased worldwide” in recent years, and this “has been especially prominent in adolescents and young adults.”

In addition, they acknowledged, “there has been a shift in gender ratio, with a preponderance toward individuals who were assigned female at birth (AFAB).”

This was the topic of “The Trans Train” programs, and in fact, following their broadcast, Ms. Indremo and colleagues noted that “an intense debate in national media [in Sweden] arose from the documentaries.”

Their research aimed to explore the association between both “positive” and “negative” media coverage and the number of referrals to gender identity clinics for young people (under aged 19) respectively. Data from the six gender clinics in Sweden were included between January 2017 and December 2019.

In the period studied, the clinics received 1,784 referrals, including 613 referrals in 2017, 663 referrals in 2018, and 508 referrals in 2019.

From the age-specific data that included 1,674 referrals, 359 individuals (21.4%) were younger than 13 years and 1,315 individuals (78.6%) were aged 13-18 years. From the assigned sex-specific data that included 1,435 referrals, 1,034 individuals (72.1%) were AFAB and 401 individuals (27.9%) were assigned male at birth (AMAB). Information on sex assigned at birth was lacking from one clinic, which was excluded from the analysis.

When they examined data for the 3 months following the airing of the first part of “The Trans Train” documentary series (in April 2019), they found that referrals to gender clinics fell by 25.4% overall, compared with the 3 months before part 1 was screened. Specifically, they fell by 25.3% for young people aged 13-18 years and by 32.2% for those born female.

In the extended analyses of 6 months following part 1, a decrease of total referrals by 30.7% was observed, while referrals for AFAB individuals decreased by 37.4% and referrals for individuals aged 13-18 years decreased by 27.7%. A decrease of referrals by 41.7% for children aged younger than 13 years was observed in the 6-month analysis, as well as a decrease of 8.2% among AMAB individuals.

“The Trans Train” documentaries, Ms. Indremo and colleagues said, “were criticized for being negatively biased and giving an oversimplified picture of transgender health care.”
 

Did the nature of the trans train documentaries influence referrals?

In an invited commentary published in JAMA Network Open, Ken C. Pang, PhD, from the Murdoch Children’s Research Institute, Melbourne, and colleagues noted: “Although the mechanisms underlying this decrease [in referrals] were not formally explored in their study, the authors reasonably speculated that both parents and referring health professionals may have been less likely to support a child or adolescent’s attendance at a specialist pediatric gender clinic following the documentaries.”

Dr. Pang and colleagues went on to say it is “the ... responsibility of media organizations in ensuring that stories depicting health care for transgender and gender diverse (TGD) young people are fair, balanced, nuanced, and accurate.”

Often, media reports have “fallen short of these standards and lacked the voices of TGD young people who have benefited from gender-affirming care or the perspectives of health professionals with expertise in providing such care,” they added.

“For example, some [media reports] have suggested that the growing number of referrals to such clinics is not owing to greater awareness of gender diversity and empowerment of TGD young people but is instead being driven by other factors such as peer influence, while others have warned that the use of gender-affirming hormonal interventions in TGD young people represents an undue risk,” they continue.

Ms. Indremo and colleagues didn’t see any drop-in referrals after the second part of the series, aired in October 2019, but they say this was likely because referrals were “already lowered” by the airing of the first part of the documentaries.

Nor did they see an increase in referrals following what they say was a “positive” media event in the form of a story about a professional Swedish handball player who announced the decision to quit his career to seek care for gender dysphoria.

“One may assume that a single news event is not significant enough to influence referral counts,” they suggested, noting also that Sweden represents “a society where there is already a relatively high level of awareness of gender identity issues.”

“Our results point to a differential association of media attention depending on the tone of the media content,” they observed.

Dr. Pang and coauthors noted it would be “helpful to examine whether similar media coverage in other countries has been associated with similar decreases in referral numbers and whether particular types of media stories are more prone to having this association.”
 

Parents and doctors debate treatment of gender dysphoria

In Sweden, custodians’ permission as well as custodians’ help is needed for minors to access care for gender dysphoria, said Ms. Indremo and coauthors. “It is possible that the content of the documentaries contributed to a higher custodian barrier to having their children referred for assessment, believing it may not be in the best interest of their child. This would highly impact young transgender individuals’ possibilities to access care.” 

They also acknowledge that health care practitioners who refer young people to specialist clinics might also have been influenced by the documentaries, noting “some commentators argued that all treatments for gender dysphoria be stopped, and that ‘all health care given at the gender identity clinics was an experiment lacking scientific basis.’ ”

In April 2021, Angela Sämfjord, MD, child and adolescent psychiatrist at Sahlgrenska University Hospital, Gothenburg, Sweden, who started a child and adolescent clinic – the Lundstrom Gender Clinic – told this news organization she had reevaluated her approach even prior to “The Trans Train” documentaries and had resigned in 2018 because of her own fears about the lack of evidence for hormonal and surgical treatments of youth with gender dysphoria.

Following the debate that ensued after the airing of “The Trans Train” programs, the Swedish National Board of Health and Welfare published new recommendations in March 2021, which reflected a significant change in direction for the evaluation of gender dysphoria in minors, emphasizing the requirement for a thorough mental health assessment.

And in May 2021, Karolinska Children’s Hospital, which houses one of the leading gender identity clinics in Sweden, announced it would stop the routine medical treatment of children with gender dysphoria under the age of 18, which meant a total ban on the prescribing of puberty blockers and cross-sex hormones to minors. Such treatment could henceforth only be carried out within the setting of a clinical trial approved by the EPM (Ethical Review Agency/Swedish Institutional Review Board), it said.

The remaining five gender identity clinics in Sweden decided upon their own rules, but in general, they have become much more cautious regarding medical treatment of minors within the past year. Also, there is a desire in Sweden to reduce the number of gender identity clinics for minors from the current six to perhaps a maximum of three nationwide.

However, neither Ms. Indremo and colleagues nor Dr. Pang and colleagues mentioned the subsequent change to the Swedish NBHW recommendations on evaluation of gender dysphoria in minors in JAMA articles.

New NBHW recommendations about medical treatment of gender dysphoria with puberty blockers and cross-sex hormones for minors were due to be issued in 2021 but have been delayed.
 

Debate in other countries

Sweden is not alone in discussing this issue. In 2020, Finland became the first country in the world to issue new guidelines that concluded there is a lack of quality evidence to support the use of hormonal interventions in adolescents with gender dysphoria.

This issue has been hotly debated in the United Kingdom – not least with the Keira Bell court case and two National Institute for Health and Clinical Excellence evidence reviews concluding there is a lack of data to support the use of puberty-blocking agents and “cross-sex” hormones in youth with gender dysphoria.

And a number of U.S. states are attempting to outlaw the medical and surgical treatment of gender dysphoria in minors. Even health care professionals who have been treating young people with gender dysphoria for years – some of whom are transgender themselves – have started to speak out and are questioning what they call “sloppy care” given to many such youth.

Indeed, a recent survey shows that detransitioners – individuals who suffer from gender dysphoria, transition to the opposite sex but then regret their decision and detransition – are getting short shrift when it comes to care, with over half of the 100 surveyed saying they feel they did not receive adequate evaluation from a doctor or mental health professional before starting to transition.

And new draft standards of care for treating people with gender dysphoria by the World Professional Association for Transgender Health have drawn criticism from experts.
 

‘First do no harm’

In their conclusion, Dr. Pang and coauthors said that, with respect to the media coverage of young people with gender dysphoria, “who are, after all, one of the most vulnerable subgroups within our society, perhaps our media should recall one of the core tenets of health care and ensure their stories ‘first, do no harm.’”

However, in a commentary recently published in Child and Adolescent Mental Health, Alison Clayton, MBBS, from the University of Melbourne, and coauthors again pointed out that evidence reviews of the use of puberty blockers in young people with gender dysphoria show “there is very low certainty of the benefits of puberty blockers, an unknown risk of harm, and there is need for more rigorous research.”

“The clinically prudent thing to do, if we aim to ‘first, do no harm,’ is to proceed with extreme caution, especially given the rapidly rising case numbers and novel gender dysphoria presentations,” Clayton and colleagues concluded.

Ms. Indremo and coauthors reported no relevant financial relationships. Dr. Pang reported being a member of the Australian Professional Association for Trans Health and its research committee. One commentary coauthor has reported being a member of WPATH.

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

Media coverage of transgender health care judged to be “negative” was associated with a drop of around 30% in referral rates to gender identity clinics in Sweden among young people under age 19, a new study indicates.

Malin Indremo, MS, from the department of neuroscience, Uppsala (Sweden) University, and colleagues explored the effect of the documentaries, “The Trans Train and Teenage Girls,” which they explain was a “Swedish public service television show” representing “investigative journalism.” The two-part documentary series was aired in Sweden in April 2019 and October 2019, respectively, and is now available in English on YouTube.

In their article, published online in JAMA Network Open, the authors said they consider “The Trans Train” programs to be “negative” media coverage because the “documentaries addressed the distinct increase among adolescents referred to gender identity clinics in recent years. Two young adults who regretted their transition and parents of transgender individuals who questioned the clinics’ assessments of their children were interviewed, and concerns were raised about whether gender-confirming treatments are based on sufficient scientific evidence.”

The programs, they suggest, may have influenced and jeopardized young transgender individuals’ access to transgender-specific health care.

Stella O’Malley, a U.K.-based psychotherapist specializing in transgender care and executive director of Genspect, an international organization that provides support to the parents of young people who are questioning their gender, expressed her disappointment with the study’s conclusions.

“I’m really surprised and disappointed that the researchers believe that negative coverage is the reason for a drop in referrals when it is more accurate to say that the information provided by ‘The Trans Train’ documentaries was concerning and suggests that further critical analysis and a review needs to be carried out on the clinics in question,” she said in an interview.

Ms. O’Malley herself made a documentary for Channel 4 in the United Kingdom, broadcast in 2018, called: “Trans Kids: It’s Time to Talk.”
 

Rapidly increasing numbers of youth, especially girls, question gender

As Ms. Indremo and coauthors explained – and as has been widely reported by this news organization – “the number of referrals to gender identity clinics have rapidly increased worldwide” in recent years, and this “has been especially prominent in adolescents and young adults.”

In addition, they acknowledged, “there has been a shift in gender ratio, with a preponderance toward individuals who were assigned female at birth (AFAB).”

This was the topic of “The Trans Train” programs, and in fact, following their broadcast, Ms. Indremo and colleagues noted that “an intense debate in national media [in Sweden] arose from the documentaries.”

Their research aimed to explore the association between both “positive” and “negative” media coverage and the number of referrals to gender identity clinics for young people (under aged 19) respectively. Data from the six gender clinics in Sweden were included between January 2017 and December 2019.

In the period studied, the clinics received 1,784 referrals, including 613 referrals in 2017, 663 referrals in 2018, and 508 referrals in 2019.

From the age-specific data that included 1,674 referrals, 359 individuals (21.4%) were younger than 13 years and 1,315 individuals (78.6%) were aged 13-18 years. From the assigned sex-specific data that included 1,435 referrals, 1,034 individuals (72.1%) were AFAB and 401 individuals (27.9%) were assigned male at birth (AMAB). Information on sex assigned at birth was lacking from one clinic, which was excluded from the analysis.

When they examined data for the 3 months following the airing of the first part of “The Trans Train” documentary series (in April 2019), they found that referrals to gender clinics fell by 25.4% overall, compared with the 3 months before part 1 was screened. Specifically, they fell by 25.3% for young people aged 13-18 years and by 32.2% for those born female.

In the extended analyses of 6 months following part 1, a decrease of total referrals by 30.7% was observed, while referrals for AFAB individuals decreased by 37.4% and referrals for individuals aged 13-18 years decreased by 27.7%. A decrease of referrals by 41.7% for children aged younger than 13 years was observed in the 6-month analysis, as well as a decrease of 8.2% among AMAB individuals.

“The Trans Train” documentaries, Ms. Indremo and colleagues said, “were criticized for being negatively biased and giving an oversimplified picture of transgender health care.”
 

Did the nature of the trans train documentaries influence referrals?

In an invited commentary published in JAMA Network Open, Ken C. Pang, PhD, from the Murdoch Children’s Research Institute, Melbourne, and colleagues noted: “Although the mechanisms underlying this decrease [in referrals] were not formally explored in their study, the authors reasonably speculated that both parents and referring health professionals may have been less likely to support a child or adolescent’s attendance at a specialist pediatric gender clinic following the documentaries.”

Dr. Pang and colleagues went on to say it is “the ... responsibility of media organizations in ensuring that stories depicting health care for transgender and gender diverse (TGD) young people are fair, balanced, nuanced, and accurate.”

Often, media reports have “fallen short of these standards and lacked the voices of TGD young people who have benefited from gender-affirming care or the perspectives of health professionals with expertise in providing such care,” they added.

“For example, some [media reports] have suggested that the growing number of referrals to such clinics is not owing to greater awareness of gender diversity and empowerment of TGD young people but is instead being driven by other factors such as peer influence, while others have warned that the use of gender-affirming hormonal interventions in TGD young people represents an undue risk,” they continue.

Ms. Indremo and colleagues didn’t see any drop-in referrals after the second part of the series, aired in October 2019, but they say this was likely because referrals were “already lowered” by the airing of the first part of the documentaries.

Nor did they see an increase in referrals following what they say was a “positive” media event in the form of a story about a professional Swedish handball player who announced the decision to quit his career to seek care for gender dysphoria.

“One may assume that a single news event is not significant enough to influence referral counts,” they suggested, noting also that Sweden represents “a society where there is already a relatively high level of awareness of gender identity issues.”

“Our results point to a differential association of media attention depending on the tone of the media content,” they observed.

Dr. Pang and coauthors noted it would be “helpful to examine whether similar media coverage in other countries has been associated with similar decreases in referral numbers and whether particular types of media stories are more prone to having this association.”
 

Parents and doctors debate treatment of gender dysphoria

In Sweden, custodians’ permission as well as custodians’ help is needed for minors to access care for gender dysphoria, said Ms. Indremo and coauthors. “It is possible that the content of the documentaries contributed to a higher custodian barrier to having their children referred for assessment, believing it may not be in the best interest of their child. This would highly impact young transgender individuals’ possibilities to access care.” 

They also acknowledge that health care practitioners who refer young people to specialist clinics might also have been influenced by the documentaries, noting “some commentators argued that all treatments for gender dysphoria be stopped, and that ‘all health care given at the gender identity clinics was an experiment lacking scientific basis.’ ”

In April 2021, Angela Sämfjord, MD, child and adolescent psychiatrist at Sahlgrenska University Hospital, Gothenburg, Sweden, who started a child and adolescent clinic – the Lundstrom Gender Clinic – told this news organization she had reevaluated her approach even prior to “The Trans Train” documentaries and had resigned in 2018 because of her own fears about the lack of evidence for hormonal and surgical treatments of youth with gender dysphoria.

Following the debate that ensued after the airing of “The Trans Train” programs, the Swedish National Board of Health and Welfare published new recommendations in March 2021, which reflected a significant change in direction for the evaluation of gender dysphoria in minors, emphasizing the requirement for a thorough mental health assessment.

And in May 2021, Karolinska Children’s Hospital, which houses one of the leading gender identity clinics in Sweden, announced it would stop the routine medical treatment of children with gender dysphoria under the age of 18, which meant a total ban on the prescribing of puberty blockers and cross-sex hormones to minors. Such treatment could henceforth only be carried out within the setting of a clinical trial approved by the EPM (Ethical Review Agency/Swedish Institutional Review Board), it said.

The remaining five gender identity clinics in Sweden decided upon their own rules, but in general, they have become much more cautious regarding medical treatment of minors within the past year. Also, there is a desire in Sweden to reduce the number of gender identity clinics for minors from the current six to perhaps a maximum of three nationwide.

However, neither Ms. Indremo and colleagues nor Dr. Pang and colleagues mentioned the subsequent change to the Swedish NBHW recommendations on evaluation of gender dysphoria in minors in JAMA articles.

New NBHW recommendations about medical treatment of gender dysphoria with puberty blockers and cross-sex hormones for minors were due to be issued in 2021 but have been delayed.
 

Debate in other countries

Sweden is not alone in discussing this issue. In 2020, Finland became the first country in the world to issue new guidelines that concluded there is a lack of quality evidence to support the use of hormonal interventions in adolescents with gender dysphoria.

This issue has been hotly debated in the United Kingdom – not least with the Keira Bell court case and two National Institute for Health and Clinical Excellence evidence reviews concluding there is a lack of data to support the use of puberty-blocking agents and “cross-sex” hormones in youth with gender dysphoria.

And a number of U.S. states are attempting to outlaw the medical and surgical treatment of gender dysphoria in minors. Even health care professionals who have been treating young people with gender dysphoria for years – some of whom are transgender themselves – have started to speak out and are questioning what they call “sloppy care” given to many such youth.

Indeed, a recent survey shows that detransitioners – individuals who suffer from gender dysphoria, transition to the opposite sex but then regret their decision and detransition – are getting short shrift when it comes to care, with over half of the 100 surveyed saying they feel they did not receive adequate evaluation from a doctor or mental health professional before starting to transition.

And new draft standards of care for treating people with gender dysphoria by the World Professional Association for Transgender Health have drawn criticism from experts.
 

‘First do no harm’

In their conclusion, Dr. Pang and coauthors said that, with respect to the media coverage of young people with gender dysphoria, “who are, after all, one of the most vulnerable subgroups within our society, perhaps our media should recall one of the core tenets of health care and ensure their stories ‘first, do no harm.’”

However, in a commentary recently published in Child and Adolescent Mental Health, Alison Clayton, MBBS, from the University of Melbourne, and coauthors again pointed out that evidence reviews of the use of puberty blockers in young people with gender dysphoria show “there is very low certainty of the benefits of puberty blockers, an unknown risk of harm, and there is need for more rigorous research.”

“The clinically prudent thing to do, if we aim to ‘first, do no harm,’ is to proceed with extreme caution, especially given the rapidly rising case numbers and novel gender dysphoria presentations,” Clayton and colleagues concluded.

Ms. Indremo and coauthors reported no relevant financial relationships. Dr. Pang reported being a member of the Australian Professional Association for Trans Health and its research committee. One commentary coauthor has reported being a member of WPATH.

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

“No one has asked young people what they want,” said Tabitha Randell, MBChB, an endocrinologist with Nottingham (England) University Hospitals NHS Trust, who specializes in treating teenagers with type 1 diabetes as they transition to adult care.

Dr. Randell, who has set up a very successful specialist service in her hospital for such patients, said: “We consistently have the best, or the second best, outcomes in this country for our diabetes patients.” She believes this is one of the most important issues in modern endocrinology today.

Speaking at the Diabetes Professional Care conference in London at the end of 2021, and sharing her thoughts afterward with this news organization, she noted that in general there are “virtually no published outcomes” on how best to transition a patient with type 1 diabetes from pediatric to adult care.

“If you actually get them to transition – because some just drop out and disengage and there’s nothing you can do – none of them get lost. Some of them disengage in the adult clinic, but if you’re in the young diabetes service [in England] the rules are that if you miss a diabetes appointment you do not get discharged, as compared with the adult clinic, where if you miss an appointment, you are discharged.”

In the young diabetes clinic, doctors will “carry on trying to contact you, and get you back,” she explained. “And the patients do eventually come back in – it might be a year or 2, but they do come back. We’ve just got to keep them alive in the meantime!”

This issue needs tackling all over the world. Dr. Randell said she’s not aware of any one country – although there may be “pockets” of good care within a given country – that is doing this perfectly.

Across the pond, Grazia Aleppo, MD, division of endocrinology at Northwestern University, Chicago, agreed that transitioning pediatric patients with type 1 diabetes to adult care presents “unique challenges.”
 

Challenges when transitioning from pediatric to adult care

During childhood, type 1 diabetes management is largely supervised by patients’ parents and members of the pediatric diabetes care team, which may include diabetes educators, psychologists, or social workers, as well as pediatric endocrinologists.

When the patient with type 1 diabetes becomes a young adult and takes over management of their own health, Dr. Aleppo said, the care team may diminish along with the time spent in provider visits.

The adult endocrinology setting focuses more on self-management and autonomous functioning of the individual with diabetes.

Adult appointments are typically shorter, and the patient is usually expected to follow doctors’ suggestions independently, she noted. They are also expected to manage the practical aspects of their diabetes care, including prescriptions, diabetes supplies, laboratory tests, scheduling, and keeping appointments.

At the same time that the emerging adult needs to start asserting independence over their health care, they will also be going through a myriad of other important lifestyle changes, such as attending college, living on their own for the first time, and starting a career.  

“With these fundamental differences and challenges, competing priorities, such as college, work and relationships, medical care may become of secondary importance and patients may become disengaged,” Dr. Aleppo explained.

As Dr. Randell has said, loss to follow-up is a big problem with this patient population, with disengagement from specialist services and worsening A1c across the transition, Dr. Aleppo noted. This makes addressing these patients’ specific needs extremely important.
 

Engage with kid, not disease; don’t palm them off on new recruits

“The really key thing these kids say is, ‘I do not want to be a disease,’” Dr. Randell said. “They want you to know that they are a person. Engage these kids!” she suggested. “Ask them: ‘How is your exam revision going?’ Find something positive to say, even if it’s just: ‘I’m glad you came today.’ ”

“If the first thing that you do is tell them off [for poor diabetes care], you are never going to see them again,” she cautioned.

Dr. Randell also said that role models with type 1 diabetes, such as Lila Moss – daughter of British supermodel Kate Moss – who was recently pictured wearing an insulin pump on her leg on the catwalk, are helping youngsters not feel so self-conscious about their diabetes.

“Let them know it’s not the end of the world, having [type 1] diabetes,” she emphasized.  

And Partha Kar, MBBS, OBE, national specialty advisor, diabetes with NHS England, agreed wholeheartedly with Dr. Randall.

Reminiscing about his early days as a newly qualified endocrinologist, Dr. Kar, who works at Portsmouth (England) Hospital NHS Trust, noted that as a new member of staff he was given the youth with type 1 diabetes – those getting ready to transition to adult care – to look after.

But this is the exact opposite of what should be happening, he emphasized. “If you don’t think transition care is important, you shouldn’t be treating type 1 diabetes.”

He believes that every diabetes center “must have a young-adult team lead” and this job must not be given to the least experienced member of staff.

This lead “doesn’t need to be a doctor,” Dr. Kar stressed. “It can be a psychologist, or a diabetes nurse, or a pharmacist, or a dietician.”

In short, it must be someone experienced who loves working with this age group.  

Dr. Randell agreed: “Make sure the team is interested in young people. It shouldn’t be the last person in who gets the job no one else wants.” Teens “are my favorite group to work with. They don’t take any nonsense.”

And she explained: “Young people like to get to know the person who’s going to take care of them. So, stay with them for their young adult years.” This can be “quite a fluid period,” with it normally extending to age 25, but in some cases, “it can be up to 32 years old.”
 

Preparing for the transition

To ease pediatric patients into the transition to adult care, Dr. Aleppo recommended that the pediatric diabetes team provide enough time so that any concerns the patient and their family may have can be addressed.

This should also include transferring management responsibilities to the young adult rather than their parent.

The pediatric provider should discuss with the patient available potential adult colleagues, personalizing these options to their needs, she said.

And the adult and pediatric clinicians should collaborate and provide important information beyond medical records or health summaries.

Adult providers should guide young adults on how to navigate the new practices, from scheduling follow-up appointments to policies regarding medication refills or supplies, to providing information about urgent numbers or email addresses for after-hours communications.

Dr. Kar reiterated that there are too few published outcomes in this patient group to guide the establishment of good transition services.

“Without data, we are dead on the ground. Without data, it’s all conjecture, anecdotes,” he said.

What he does know is that, in the latest national type 1 diabetes audit for England, “Diabetic ketoacidosis admissions ... are up in this age group,” which suggests these patients are not receiving adequate care.
 

Be a guide, not a gatekeeper

Dr. Kar stressed that, of the 8,760 hours in a year, the average patient with type 1 diabetes in the United Kingdom gets just “1-2 hours with you as a clinician, based on four appointments per year of 30 minutes each.”

“So you spend 0.02% of their time with individuals with type 1 diabetes. So, what’s the one thing you can do with that minimal contact? Be nice!”

Dr. Kar said he always has his email open to his adult patients and they are very respectful of his time. “They don’t email you at 1 a.m. That means every one of my patients has got support [from me]. Don’t be a barrier.”

“We have to fundamentally change the narrative. Doctors must have more empathy,” he said, stating that the one thing adolescents have constantly given feedback on has been, “Why don’t appointments start with: ‘How are you?’ 

“For a teenager, if you throw type 1 diabetes into the loop, it’s not easy,” he stressed. “Talk to them about something else. As a clinician, be a guide, not a gatekeeper. Give people the tools to self-manage better.”

Adult providers can meet these young adult patients “at their level,” Dr. Aleppo agreed.

“Pay attention to their immediate needs and focus on their present circumstances – whether how to get through their next semester in college, navigating job interviews, or handling having diabetes in the workplace.”

Paying attention to the mental health needs of these young patients is equally “paramount,” Dr. Aleppo said.

While access to mental health professionals may be challenging in the adult setting, providers should bring it up with their patients and offer counseling referrals.

“Diabetes impacts everything, and office appointments and conversations carry weight on these patients’ lives as a whole, not just on their diabetes,” she stressed. “A patient told me recently: ‘We’re learning to be adults,’ which can be hard enough, and with diabetes it can be even more challenging. Adult providers need to be aware of the patient’s ‘diabetes language’ in that often it is not what a patient is saying, rather how they are saying it that gives us information on what they truly need.

“As adult providers, we need to also train and teach our young patients to advocate for themselves on where to find resources that can help them navigate adulthood with diabetes,” she added.

One particularly helpful resource in the United States is the College Diabetes Network, a not-for-profit organization whose mission is to equip young adults with type 1 diabetes to successfully manage the challenging transition to independence at college and beyond.

“The sweetest thing that can happen to us as adult diabetes providers is when a patient – seen as an emerging adult during college – returns to your practice 10 years later after moving back and seeks you out for their diabetes care because of the relationship and trust you developed in those transitioning years,” Dr. Aleppo said.

Another resource is a freely available comic book series cocreated by Dr. Kar and colleague Mayank Patel, MBBS, an endocrinologist from University Hospital Southampton NHS Foundation Trust.

As detailed by this news organization in 2021, the series consists of three volumes: the first, Type 1: Origins, focuses on actual experiences of patients who have type 1 diabetes; the second, Type 1: Attack of the Ketones, is aimed at professionals who may provide care but have limited understanding of type 1 diabetes; and the third, Type 1 Mission 3: S.T.I.G.M.A., addresses the stigmas and misconceptions that patients with type 1 diabetes may face.

The idea for the first comic was inspired by a patient who compared having diabetes to being like the Marvel character The Hulk, said Dr. Kar, and has been expanded to include the additional volumes.

Dr. Kar and Dr. Patel have also just launched the fourth comic in the series, Type 1: Generations, to mark the 100-year anniversary since insulin was first given to a human.
 

“This is high priority”  

Dr. Kar said the NHS in England has just appointed a national lead for type 1 diabetes in youth, Fulya Mehta, MD, of Alder Hey Children’s NHS Foundation Trust, Liverpool, England.

“If you have a plan, bring it to us,” he told the audience at the DPC conference, and “tell us, what is the one thing you would change? This is not a session we are doing just to tick a box. This is high priority.

“Encourage your colleagues to think about transition services. This is an absolute priority. We will be asking every center [in England] who is your transitioning lead?”

And he once again stressed that “a lead of transition service does not have to be a medic. This should be a multidisciplinary team. But they do need to be comfortable in that space. To that teenager, your job title means nothing. Give them time and space.”

Dr. Randell summed it up: “If we can work together, it’s only going to result in better outcomes. We need to blaze the trail for young people.”

Dr. Aleppo has reported serving as a consultant to Dexcom and Insulet and receiving support to Northwestern University from AstraZeneca, Dexcom, Eli Lilly, Fractyl Health, Insulet, and Novo Nordisk. Dr. Randell and Dr. Kar have no conflicts of interest.

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

“No one has asked young people what they want,” said Tabitha Randell, MBChB, an endocrinologist with Nottingham (England) University Hospitals NHS Trust, who specializes in treating teenagers with type 1 diabetes as they transition to adult care.

Dr. Randell, who has set up a very successful specialist service in her hospital for such patients, said: “We consistently have the best, or the second best, outcomes in this country for our diabetes patients.” She believes this is one of the most important issues in modern endocrinology today.

Speaking at the Diabetes Professional Care conference in London at the end of 2021, and sharing her thoughts afterward with this news organization, she noted that in general there are “virtually no published outcomes” on how best to transition a patient with type 1 diabetes from pediatric to adult care.

“If you actually get them to transition – because some just drop out and disengage and there’s nothing you can do – none of them get lost. Some of them disengage in the adult clinic, but if you’re in the young diabetes service [in England] the rules are that if you miss a diabetes appointment you do not get discharged, as compared with the adult clinic, where if you miss an appointment, you are discharged.”

In the young diabetes clinic, doctors will “carry on trying to contact you, and get you back,” she explained. “And the patients do eventually come back in – it might be a year or 2, but they do come back. We’ve just got to keep them alive in the meantime!”

This issue needs tackling all over the world. Dr. Randell said she’s not aware of any one country – although there may be “pockets” of good care within a given country – that is doing this perfectly.

Across the pond, Grazia Aleppo, MD, division of endocrinology at Northwestern University, Chicago, agreed that transitioning pediatric patients with type 1 diabetes to adult care presents “unique challenges.”
 

Challenges when transitioning from pediatric to adult care

During childhood, type 1 diabetes management is largely supervised by patients’ parents and members of the pediatric diabetes care team, which may include diabetes educators, psychologists, or social workers, as well as pediatric endocrinologists.

When the patient with type 1 diabetes becomes a young adult and takes over management of their own health, Dr. Aleppo said, the care team may diminish along with the time spent in provider visits.

The adult endocrinology setting focuses more on self-management and autonomous functioning of the individual with diabetes.

Adult appointments are typically shorter, and the patient is usually expected to follow doctors’ suggestions independently, she noted. They are also expected to manage the practical aspects of their diabetes care, including prescriptions, diabetes supplies, laboratory tests, scheduling, and keeping appointments.

At the same time that the emerging adult needs to start asserting independence over their health care, they will also be going through a myriad of other important lifestyle changes, such as attending college, living on their own for the first time, and starting a career.  

“With these fundamental differences and challenges, competing priorities, such as college, work and relationships, medical care may become of secondary importance and patients may become disengaged,” Dr. Aleppo explained.

As Dr. Randell has said, loss to follow-up is a big problem with this patient population, with disengagement from specialist services and worsening A1c across the transition, Dr. Aleppo noted. This makes addressing these patients’ specific needs extremely important.
 

Engage with kid, not disease; don’t palm them off on new recruits

“The really key thing these kids say is, ‘I do not want to be a disease,’” Dr. Randell said. “They want you to know that they are a person. Engage these kids!” she suggested. “Ask them: ‘How is your exam revision going?’ Find something positive to say, even if it’s just: ‘I’m glad you came today.’ ”

“If the first thing that you do is tell them off [for poor diabetes care], you are never going to see them again,” she cautioned.

Dr. Randell also said that role models with type 1 diabetes, such as Lila Moss – daughter of British supermodel Kate Moss – who was recently pictured wearing an insulin pump on her leg on the catwalk, are helping youngsters not feel so self-conscious about their diabetes.

“Let them know it’s not the end of the world, having [type 1] diabetes,” she emphasized.  

And Partha Kar, MBBS, OBE, national specialty advisor, diabetes with NHS England, agreed wholeheartedly with Dr. Randall.

Reminiscing about his early days as a newly qualified endocrinologist, Dr. Kar, who works at Portsmouth (England) Hospital NHS Trust, noted that as a new member of staff he was given the youth with type 1 diabetes – those getting ready to transition to adult care – to look after.

But this is the exact opposite of what should be happening, he emphasized. “If you don’t think transition care is important, you shouldn’t be treating type 1 diabetes.”

He believes that every diabetes center “must have a young-adult team lead” and this job must not be given to the least experienced member of staff.

This lead “doesn’t need to be a doctor,” Dr. Kar stressed. “It can be a psychologist, or a diabetes nurse, or a pharmacist, or a dietician.”

In short, it must be someone experienced who loves working with this age group.  

Dr. Randell agreed: “Make sure the team is interested in young people. It shouldn’t be the last person in who gets the job no one else wants.” Teens “are my favorite group to work with. They don’t take any nonsense.”

And she explained: “Young people like to get to know the person who’s going to take care of them. So, stay with them for their young adult years.” This can be “quite a fluid period,” with it normally extending to age 25, but in some cases, “it can be up to 32 years old.”
 

Preparing for the transition

To ease pediatric patients into the transition to adult care, Dr. Aleppo recommended that the pediatric diabetes team provide enough time so that any concerns the patient and their family may have can be addressed.

This should also include transferring management responsibilities to the young adult rather than their parent.

The pediatric provider should discuss with the patient available potential adult colleagues, personalizing these options to their needs, she said.

And the adult and pediatric clinicians should collaborate and provide important information beyond medical records or health summaries.

Adult providers should guide young adults on how to navigate the new practices, from scheduling follow-up appointments to policies regarding medication refills or supplies, to providing information about urgent numbers or email addresses for after-hours communications.

Dr. Kar reiterated that there are too few published outcomes in this patient group to guide the establishment of good transition services.

“Without data, we are dead on the ground. Without data, it’s all conjecture, anecdotes,” he said.

What he does know is that, in the latest national type 1 diabetes audit for England, “Diabetic ketoacidosis admissions ... are up in this age group,” which suggests these patients are not receiving adequate care.
 

Be a guide, not a gatekeeper

Dr. Kar stressed that, of the 8,760 hours in a year, the average patient with type 1 diabetes in the United Kingdom gets just “1-2 hours with you as a clinician, based on four appointments per year of 30 minutes each.”

“So you spend 0.02% of their time with individuals with type 1 diabetes. So, what’s the one thing you can do with that minimal contact? Be nice!”

Dr. Kar said he always has his email open to his adult patients and they are very respectful of his time. “They don’t email you at 1 a.m. That means every one of my patients has got support [from me]. Don’t be a barrier.”

“We have to fundamentally change the narrative. Doctors must have more empathy,” he said, stating that the one thing adolescents have constantly given feedback on has been, “Why don’t appointments start with: ‘How are you?’ 

“For a teenager, if you throw type 1 diabetes into the loop, it’s not easy,” he stressed. “Talk to them about something else. As a clinician, be a guide, not a gatekeeper. Give people the tools to self-manage better.”

Adult providers can meet these young adult patients “at their level,” Dr. Aleppo agreed.

“Pay attention to their immediate needs and focus on their present circumstances – whether how to get through their next semester in college, navigating job interviews, or handling having diabetes in the workplace.”

Paying attention to the mental health needs of these young patients is equally “paramount,” Dr. Aleppo said.

While access to mental health professionals may be challenging in the adult setting, providers should bring it up with their patients and offer counseling referrals.

“Diabetes impacts everything, and office appointments and conversations carry weight on these patients’ lives as a whole, not just on their diabetes,” she stressed. “A patient told me recently: ‘We’re learning to be adults,’ which can be hard enough, and with diabetes it can be even more challenging. Adult providers need to be aware of the patient’s ‘diabetes language’ in that often it is not what a patient is saying, rather how they are saying it that gives us information on what they truly need.

“As adult providers, we need to also train and teach our young patients to advocate for themselves on where to find resources that can help them navigate adulthood with diabetes,” she added.

One particularly helpful resource in the United States is the College Diabetes Network, a not-for-profit organization whose mission is to equip young adults with type 1 diabetes to successfully manage the challenging transition to independence at college and beyond.

“The sweetest thing that can happen to us as adult diabetes providers is when a patient – seen as an emerging adult during college – returns to your practice 10 years later after moving back and seeks you out for their diabetes care because of the relationship and trust you developed in those transitioning years,” Dr. Aleppo said.

Another resource is a freely available comic book series cocreated by Dr. Kar and colleague Mayank Patel, MBBS, an endocrinologist from University Hospital Southampton NHS Foundation Trust.

As detailed by this news organization in 2021, the series consists of three volumes: the first, Type 1: Origins, focuses on actual experiences of patients who have type 1 diabetes; the second, Type 1: Attack of the Ketones, is aimed at professionals who may provide care but have limited understanding of type 1 diabetes; and the third, Type 1 Mission 3: S.T.I.G.M.A., addresses the stigmas and misconceptions that patients with type 1 diabetes may face.

The idea for the first comic was inspired by a patient who compared having diabetes to being like the Marvel character The Hulk, said Dr. Kar, and has been expanded to include the additional volumes.

Dr. Kar and Dr. Patel have also just launched the fourth comic in the series, Type 1: Generations, to mark the 100-year anniversary since insulin was first given to a human.
 

“This is high priority”  

Dr. Kar said the NHS in England has just appointed a national lead for type 1 diabetes in youth, Fulya Mehta, MD, of Alder Hey Children’s NHS Foundation Trust, Liverpool, England.

“If you have a plan, bring it to us,” he told the audience at the DPC conference, and “tell us, what is the one thing you would change? This is not a session we are doing just to tick a box. This is high priority.

“Encourage your colleagues to think about transition services. This is an absolute priority. We will be asking every center [in England] who is your transitioning lead?”

And he once again stressed that “a lead of transition service does not have to be a medic. This should be a multidisciplinary team. But they do need to be comfortable in that space. To that teenager, your job title means nothing. Give them time and space.”

Dr. Randell summed it up: “If we can work together, it’s only going to result in better outcomes. We need to blaze the trail for young people.”

Dr. Aleppo has reported serving as a consultant to Dexcom and Insulet and receiving support to Northwestern University from AstraZeneca, Dexcom, Eli Lilly, Fractyl Health, Insulet, and Novo Nordisk. Dr. Randell and Dr. Kar have no conflicts of interest.

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

“No one has asked young people what they want,” said Tabitha Randell, MBChB, an endocrinologist with Nottingham (England) University Hospitals NHS Trust, who specializes in treating teenagers with type 1 diabetes as they transition to adult care.

Dr. Randell, who has set up a very successful specialist service in her hospital for such patients, said: “We consistently have the best, or the second best, outcomes in this country for our diabetes patients.” She believes this is one of the most important issues in modern endocrinology today.

Speaking at the Diabetes Professional Care conference in London at the end of 2021, and sharing her thoughts afterward with this news organization, she noted that in general there are “virtually no published outcomes” on how best to transition a patient with type 1 diabetes from pediatric to adult care.

“If you actually get them to transition – because some just drop out and disengage and there’s nothing you can do – none of them get lost. Some of them disengage in the adult clinic, but if you’re in the young diabetes service [in England] the rules are that if you miss a diabetes appointment you do not get discharged, as compared with the adult clinic, where if you miss an appointment, you are discharged.”

In the young diabetes clinic, doctors will “carry on trying to contact you, and get you back,” she explained. “And the patients do eventually come back in – it might be a year or 2, but they do come back. We’ve just got to keep them alive in the meantime!”

This issue needs tackling all over the world. Dr. Randell said she’s not aware of any one country – although there may be “pockets” of good care within a given country – that is doing this perfectly.

Across the pond, Grazia Aleppo, MD, division of endocrinology at Northwestern University, Chicago, agreed that transitioning pediatric patients with type 1 diabetes to adult care presents “unique challenges.”
 

Challenges when transitioning from pediatric to adult care

During childhood, type 1 diabetes management is largely supervised by patients’ parents and members of the pediatric diabetes care team, which may include diabetes educators, psychologists, or social workers, as well as pediatric endocrinologists.

When the patient with type 1 diabetes becomes a young adult and takes over management of their own health, Dr. Aleppo said, the care team may diminish along with the time spent in provider visits.

The adult endocrinology setting focuses more on self-management and autonomous functioning of the individual with diabetes.

Adult appointments are typically shorter, and the patient is usually expected to follow doctors’ suggestions independently, she noted. They are also expected to manage the practical aspects of their diabetes care, including prescriptions, diabetes supplies, laboratory tests, scheduling, and keeping appointments.

At the same time that the emerging adult needs to start asserting independence over their health care, they will also be going through a myriad of other important lifestyle changes, such as attending college, living on their own for the first time, and starting a career.  

“With these fundamental differences and challenges, competing priorities, such as college, work and relationships, medical care may become of secondary importance and patients may become disengaged,” Dr. Aleppo explained.

As Dr. Randell has said, loss to follow-up is a big problem with this patient population, with disengagement from specialist services and worsening A1c across the transition, Dr. Aleppo noted. This makes addressing these patients’ specific needs extremely important.
 

Engage with kid, not disease; don’t palm them off on new recruits

“The really key thing these kids say is, ‘I do not want to be a disease,’” Dr. Randell said. “They want you to know that they are a person. Engage these kids!” she suggested. “Ask them: ‘How is your exam revision going?’ Find something positive to say, even if it’s just: ‘I’m glad you came today.’ ”

“If the first thing that you do is tell them off [for poor diabetes care], you are never going to see them again,” she cautioned.

Dr. Randell also said that role models with type 1 diabetes, such as Lila Moss – daughter of British supermodel Kate Moss – who was recently pictured wearing an insulin pump on her leg on the catwalk, are helping youngsters not feel so self-conscious about their diabetes.

“Let them know it’s not the end of the world, having [type 1] diabetes,” she emphasized.  

And Partha Kar, MBBS, OBE, national specialty advisor, diabetes with NHS England, agreed wholeheartedly with Dr. Randall.

Reminiscing about his early days as a newly qualified endocrinologist, Dr. Kar, who works at Portsmouth (England) Hospital NHS Trust, noted that as a new member of staff he was given the youth with type 1 diabetes – those getting ready to transition to adult care – to look after.

But this is the exact opposite of what should be happening, he emphasized. “If you don’t think transition care is important, you shouldn’t be treating type 1 diabetes.”

He believes that every diabetes center “must have a young-adult team lead” and this job must not be given to the least experienced member of staff.

This lead “doesn’t need to be a doctor,” Dr. Kar stressed. “It can be a psychologist, or a diabetes nurse, or a pharmacist, or a dietician.”

In short, it must be someone experienced who loves working with this age group.  

Dr. Randell agreed: “Make sure the team is interested in young people. It shouldn’t be the last person in who gets the job no one else wants.” Teens “are my favorite group to work with. They don’t take any nonsense.”

And she explained: “Young people like to get to know the person who’s going to take care of them. So, stay with them for their young adult years.” This can be “quite a fluid period,” with it normally extending to age 25, but in some cases, “it can be up to 32 years old.”
 

Preparing for the transition

To ease pediatric patients into the transition to adult care, Dr. Aleppo recommended that the pediatric diabetes team provide enough time so that any concerns the patient and their family may have can be addressed.

This should also include transferring management responsibilities to the young adult rather than their parent.

The pediatric provider should discuss with the patient available potential adult colleagues, personalizing these options to their needs, she said.

And the adult and pediatric clinicians should collaborate and provide important information beyond medical records or health summaries.

Adult providers should guide young adults on how to navigate the new practices, from scheduling follow-up appointments to policies regarding medication refills or supplies, to providing information about urgent numbers or email addresses for after-hours communications.

Dr. Kar reiterated that there are too few published outcomes in this patient group to guide the establishment of good transition services.

“Without data, we are dead on the ground. Without data, it’s all conjecture, anecdotes,” he said.

What he does know is that, in the latest national type 1 diabetes audit for England, “Diabetic ketoacidosis admissions ... are up in this age group,” which suggests these patients are not receiving adequate care.
 

Be a guide, not a gatekeeper

Dr. Kar stressed that, of the 8,760 hours in a year, the average patient with type 1 diabetes in the United Kingdom gets just “1-2 hours with you as a clinician, based on four appointments per year of 30 minutes each.”

“So you spend 0.02% of their time with individuals with type 1 diabetes. So, what’s the one thing you can do with that minimal contact? Be nice!”

Dr. Kar said he always has his email open to his adult patients and they are very respectful of his time. “They don’t email you at 1 a.m. That means every one of my patients has got support [from me]. Don’t be a barrier.”

“We have to fundamentally change the narrative. Doctors must have more empathy,” he said, stating that the one thing adolescents have constantly given feedback on has been, “Why don’t appointments start with: ‘How are you?’ 

“For a teenager, if you throw type 1 diabetes into the loop, it’s not easy,” he stressed. “Talk to them about something else. As a clinician, be a guide, not a gatekeeper. Give people the tools to self-manage better.”

Adult providers can meet these young adult patients “at their level,” Dr. Aleppo agreed.

“Pay attention to their immediate needs and focus on their present circumstances – whether how to get through their next semester in college, navigating job interviews, or handling having diabetes in the workplace.”

Paying attention to the mental health needs of these young patients is equally “paramount,” Dr. Aleppo said.

While access to mental health professionals may be challenging in the adult setting, providers should bring it up with their patients and offer counseling referrals.

“Diabetes impacts everything, and office appointments and conversations carry weight on these patients’ lives as a whole, not just on their diabetes,” she stressed. “A patient told me recently: ‘We’re learning to be adults,’ which can be hard enough, and with diabetes it can be even more challenging. Adult providers need to be aware of the patient’s ‘diabetes language’ in that often it is not what a patient is saying, rather how they are saying it that gives us information on what they truly need.

“As adult providers, we need to also train and teach our young patients to advocate for themselves on where to find resources that can help them navigate adulthood with diabetes,” she added.

One particularly helpful resource in the United States is the College Diabetes Network, a not-for-profit organization whose mission is to equip young adults with type 1 diabetes to successfully manage the challenging transition to independence at college and beyond.

“The sweetest thing that can happen to us as adult diabetes providers is when a patient – seen as an emerging adult during college – returns to your practice 10 years later after moving back and seeks you out for their diabetes care because of the relationship and trust you developed in those transitioning years,” Dr. Aleppo said.

Another resource is a freely available comic book series cocreated by Dr. Kar and colleague Mayank Patel, MBBS, an endocrinologist from University Hospital Southampton NHS Foundation Trust.

As detailed by this news organization in 2021, the series consists of three volumes: the first, Type 1: Origins, focuses on actual experiences of patients who have type 1 diabetes; the second, Type 1: Attack of the Ketones, is aimed at professionals who may provide care but have limited understanding of type 1 diabetes; and the third, Type 1 Mission 3: S.T.I.G.M.A., addresses the stigmas and misconceptions that patients with type 1 diabetes may face.

The idea for the first comic was inspired by a patient who compared having diabetes to being like the Marvel character The Hulk, said Dr. Kar, and has been expanded to include the additional volumes.

Dr. Kar and Dr. Patel have also just launched the fourth comic in the series, Type 1: Generations, to mark the 100-year anniversary since insulin was first given to a human.
 

“This is high priority”  

Dr. Kar said the NHS in England has just appointed a national lead for type 1 diabetes in youth, Fulya Mehta, MD, of Alder Hey Children’s NHS Foundation Trust, Liverpool, England.

“If you have a plan, bring it to us,” he told the audience at the DPC conference, and “tell us, what is the one thing you would change? This is not a session we are doing just to tick a box. This is high priority.

“Encourage your colleagues to think about transition services. This is an absolute priority. We will be asking every center [in England] who is your transitioning lead?”

And he once again stressed that “a lead of transition service does not have to be a medic. This should be a multidisciplinary team. But they do need to be comfortable in that space. To that teenager, your job title means nothing. Give them time and space.”

Dr. Randell summed it up: “If we can work together, it’s only going to result in better outcomes. We need to blaze the trail for young people.”

Dr. Aleppo has reported serving as a consultant to Dexcom and Insulet and receiving support to Northwestern University from AstraZeneca, Dexcom, Eli Lilly, Fractyl Health, Insulet, and Novo Nordisk. Dr. Randell and Dr. Kar have no conflicts of interest.

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

The drumbeat of U.S. recalls continues for various lots of extended-release metformin because of contamination with unacceptably high levels of a nitrosamine that pose a cancer risk.

On Dec. 28, 2021, Viona Pharmaceuticals voluntarily recalled 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg to the retail level, as a precautionary measure, because of possible contamination with N-nitrosodimethylamine (NDMA).

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment

The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z,” “C” on one side and “20” on the other side, and come in bottles of 100 tablets, which have been distributed nationwide. The 33 batch numbers are listed in a company statement.

The affected product was manufactured by Cadila Healthcare, Ahmedabad, India, for U.S. distribution by Viona.

In its statement, Viona said: “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

This recall is being conducted “with the knowledge of the U.S. Food and Drug Administration,” it added.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday-Friday, 8:00 a.m.–7:00 p.m. CT. Customers with medical-related questions who wish to report an adverse event or quality issues about the products being recalled should contact Viona Pharmaceuticals by phone at 888-304-5011, Monday-Friday, 8:30 p.m.–5:30 p.m., EST.
 

Latest in a long line of metformin recalls

This is the second time in 2021 that Viona has voluntarily recalled extended-release metformin tablets, 750 mg, because of potential contamination with NDMA. It recalled two lots in June, as reported by this news organization.

And in January 2021, Nostrum Laboratories recalled another lot of metformin extended-release 750-mg tablets, following on from a prior recall in November 2020.

These recalls follows 258 distinct U.S. lot recalls tracked by the FDA during the past 2 years because of unacceptably high NDMA levels in lots of metformin hydrochloride extended-release tablets.

The FDA has issued several statements about NDMA contamination of metformin formulations over the past 2 years, including a review of the methods used to detect NDMA and a summary of the information the agency had collected on excessive levels of NDMA in metformin.

According to the FDA’s 2020 summary, the agency has not yet determined how or why high levels of NDMA turn up so often in multiple batches of metformin hydrochloride extended-release tablets. However, published research attributed the contamination to certain methods of manufacturing metformin tablets.

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

The drumbeat of U.S. recalls continues for various lots of extended-release metformin because of contamination with unacceptably high levels of a nitrosamine that pose a cancer risk.

On Dec. 28, 2021, Viona Pharmaceuticals voluntarily recalled 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg to the retail level, as a precautionary measure, because of possible contamination with N-nitrosodimethylamine (NDMA).

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment

The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z,” “C” on one side and “20” on the other side, and come in bottles of 100 tablets, which have been distributed nationwide. The 33 batch numbers are listed in a company statement.

The affected product was manufactured by Cadila Healthcare, Ahmedabad, India, for U.S. distribution by Viona.

In its statement, Viona said: “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

This recall is being conducted “with the knowledge of the U.S. Food and Drug Administration,” it added.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday-Friday, 8:00 a.m.–7:00 p.m. CT. Customers with medical-related questions who wish to report an adverse event or quality issues about the products being recalled should contact Viona Pharmaceuticals by phone at 888-304-5011, Monday-Friday, 8:30 p.m.–5:30 p.m., EST.
 

Latest in a long line of metformin recalls

This is the second time in 2021 that Viona has voluntarily recalled extended-release metformin tablets, 750 mg, because of potential contamination with NDMA. It recalled two lots in June, as reported by this news organization.

And in January 2021, Nostrum Laboratories recalled another lot of metformin extended-release 750-mg tablets, following on from a prior recall in November 2020.

These recalls follows 258 distinct U.S. lot recalls tracked by the FDA during the past 2 years because of unacceptably high NDMA levels in lots of metformin hydrochloride extended-release tablets.

The FDA has issued several statements about NDMA contamination of metformin formulations over the past 2 years, including a review of the methods used to detect NDMA and a summary of the information the agency had collected on excessive levels of NDMA in metformin.

According to the FDA’s 2020 summary, the agency has not yet determined how or why high levels of NDMA turn up so often in multiple batches of metformin hydrochloride extended-release tablets. However, published research attributed the contamination to certain methods of manufacturing metformin tablets.

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

The drumbeat of U.S. recalls continues for various lots of extended-release metformin because of contamination with unacceptably high levels of a nitrosamine that pose a cancer risk.

On Dec. 28, 2021, Viona Pharmaceuticals voluntarily recalled 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg to the retail level, as a precautionary measure, because of possible contamination with N-nitrosodimethylamine (NDMA).

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment

The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z,” “C” on one side and “20” on the other side, and come in bottles of 100 tablets, which have been distributed nationwide. The 33 batch numbers are listed in a company statement.

The affected product was manufactured by Cadila Healthcare, Ahmedabad, India, for U.S. distribution by Viona.

In its statement, Viona said: “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

This recall is being conducted “with the knowledge of the U.S. Food and Drug Administration,” it added.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday-Friday, 8:00 a.m.–7:00 p.m. CT. Customers with medical-related questions who wish to report an adverse event or quality issues about the products being recalled should contact Viona Pharmaceuticals by phone at 888-304-5011, Monday-Friday, 8:30 p.m.–5:30 p.m., EST.
 

Latest in a long line of metformin recalls

This is the second time in 2021 that Viona has voluntarily recalled extended-release metformin tablets, 750 mg, because of potential contamination with NDMA. It recalled two lots in June, as reported by this news organization.

And in January 2021, Nostrum Laboratories recalled another lot of metformin extended-release 750-mg tablets, following on from a prior recall in November 2020.

These recalls follows 258 distinct U.S. lot recalls tracked by the FDA during the past 2 years because of unacceptably high NDMA levels in lots of metformin hydrochloride extended-release tablets.

The FDA has issued several statements about NDMA contamination of metformin formulations over the past 2 years, including a review of the methods used to detect NDMA and a summary of the information the agency had collected on excessive levels of NDMA in metformin.

According to the FDA’s 2020 summary, the agency has not yet determined how or why high levels of NDMA turn up so often in multiple batches of metformin hydrochloride extended-release tablets. However, published research attributed the contamination to certain methods of manufacturing metformin tablets.

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

The American Academy of Pediatrics (AAP) is at the center of a row with an international group of doctors who question whether hormone treatment is the most appropriate way to treat adolescents with gender dysphoria.

After initially accepting the application and payment from the Society for Evidence-Based Gender Medicine (SEGM) for the organization to have an information booth at the AAP annual meeting in October, the AAP did a U-turn earlier this month and canceled the registration, with no explanation as to why.

“Just days earlier,” says SEGM in a statement on its website, “over 80% of AAP members” had indicated they wanted more discussion on the topic of “addressing alternatives to the use of hormone therapies for gender dysphoric youth.”

“This rejection sends a strong signal that the AAP does not want to see any debate on what constitutes evidence-based care for gender-diverse youth,” they add.

Asked for an explanation as to why it accepted but later rescinded SEGM’s application for a booth, the AAP has given no response to date.

A Wall Street Journal article on the furor, published last week, has clocked up 785 comments to date.  

There has been an exponential increase in the number of adolescents who identify as transgender – reporting discomfort with their birth sex – in Western countries, and the debate has been covered in detail, having intensified worldwide in the last 12 months, regarding how best to treat youth with gender dysphoria.

Although “affirmative” medical care, defined as treatment with puberty blockers and cross-sex hormones to transition to the opposite sex, is supported by the AAP and other medical organizations, there is growing concern among many doctors and other health care professionals as to whether this is, in fact, the best way to proceed, given that there are a number of irreversible changes associated with treatment. There is also a growing number of “detransitioners” – mostly young people who transitioned and then changed their minds, and “detransitioned” back to their birth sex.

“Because of the low quality of the available evidence and the marked change in the presentation of gender dysphoria in youth in the last several years (many more adolescents with recently emerging transgender identities and significant mental health comorbidities are presenting for care), what constitutes good health care for this patient group is far from clear,” notes SEGM.

“Quelling the debate will not help America’s pediatricians guide patients and their families based on best available evidence. The politicization of the field of gender medicine must end, if we care about gender-variant youth and their long-term health,” they conclude.

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

The American Academy of Pediatrics (AAP) is at the center of a row with an international group of doctors who question whether hormone treatment is the most appropriate way to treat adolescents with gender dysphoria.

After initially accepting the application and payment from the Society for Evidence-Based Gender Medicine (SEGM) for the organization to have an information booth at the AAP annual meeting in October, the AAP did a U-turn earlier this month and canceled the registration, with no explanation as to why.

“Just days earlier,” says SEGM in a statement on its website, “over 80% of AAP members” had indicated they wanted more discussion on the topic of “addressing alternatives to the use of hormone therapies for gender dysphoric youth.”

“This rejection sends a strong signal that the AAP does not want to see any debate on what constitutes evidence-based care for gender-diverse youth,” they add.

Asked for an explanation as to why it accepted but later rescinded SEGM’s application for a booth, the AAP has given no response to date.

A Wall Street Journal article on the furor, published last week, has clocked up 785 comments to date.  

There has been an exponential increase in the number of adolescents who identify as transgender – reporting discomfort with their birth sex – in Western countries, and the debate has been covered in detail, having intensified worldwide in the last 12 months, regarding how best to treat youth with gender dysphoria.

Although “affirmative” medical care, defined as treatment with puberty blockers and cross-sex hormones to transition to the opposite sex, is supported by the AAP and other medical organizations, there is growing concern among many doctors and other health care professionals as to whether this is, in fact, the best way to proceed, given that there are a number of irreversible changes associated with treatment. There is also a growing number of “detransitioners” – mostly young people who transitioned and then changed their minds, and “detransitioned” back to their birth sex.

“Because of the low quality of the available evidence and the marked change in the presentation of gender dysphoria in youth in the last several years (many more adolescents with recently emerging transgender identities and significant mental health comorbidities are presenting for care), what constitutes good health care for this patient group is far from clear,” notes SEGM.

“Quelling the debate will not help America’s pediatricians guide patients and their families based on best available evidence. The politicization of the field of gender medicine must end, if we care about gender-variant youth and their long-term health,” they conclude.

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

The American Academy of Pediatrics (AAP) is at the center of a row with an international group of doctors who question whether hormone treatment is the most appropriate way to treat adolescents with gender dysphoria.

After initially accepting the application and payment from the Society for Evidence-Based Gender Medicine (SEGM) for the organization to have an information booth at the AAP annual meeting in October, the AAP did a U-turn earlier this month and canceled the registration, with no explanation as to why.

“Just days earlier,” says SEGM in a statement on its website, “over 80% of AAP members” had indicated they wanted more discussion on the topic of “addressing alternatives to the use of hormone therapies for gender dysphoric youth.”

“This rejection sends a strong signal that the AAP does not want to see any debate on what constitutes evidence-based care for gender-diverse youth,” they add.

Asked for an explanation as to why it accepted but later rescinded SEGM’s application for a booth, the AAP has given no response to date.

A Wall Street Journal article on the furor, published last week, has clocked up 785 comments to date.  

There has been an exponential increase in the number of adolescents who identify as transgender – reporting discomfort with their birth sex – in Western countries, and the debate has been covered in detail, having intensified worldwide in the last 12 months, regarding how best to treat youth with gender dysphoria.

Although “affirmative” medical care, defined as treatment with puberty blockers and cross-sex hormones to transition to the opposite sex, is supported by the AAP and other medical organizations, there is growing concern among many doctors and other health care professionals as to whether this is, in fact, the best way to proceed, given that there are a number of irreversible changes associated with treatment. There is also a growing number of “detransitioners” – mostly young people who transitioned and then changed their minds, and “detransitioned” back to their birth sex.

“Because of the low quality of the available evidence and the marked change in the presentation of gender dysphoria in youth in the last several years (many more adolescents with recently emerging transgender identities and significant mental health comorbidities are presenting for care), what constitutes good health care for this patient group is far from clear,” notes SEGM.

“Quelling the debate will not help America’s pediatricians guide patients and their families based on best available evidence. The politicization of the field of gender medicine must end, if we care about gender-variant youth and their long-term health,” they conclude.

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

Hundreds of thousands of deaths worldwide from COVID-19 could have been avoided if obesity rates were lower, a new report says.

An analysis by the World Obesity Federation found that of the 2.5 million COVID-19 deaths reported by the end of February 2021, almost 90% (2.2 million) were in countries where more than half the population is classified as overweight.

The report, released to coincide with World Obesity Day, calls for obesity to be recognized as a disease in its own right around the world, and for people with obesity to be included in priority lists for COVID-19 testing and vaccination.

“Overweight is a highly significant predictor of developing complications from COVID-19, including the need for hospitalization, for intensive care and for mechanical ventilation,” the WOF notes in the report.

It adds that in countries where less than half the adult population is classified as overweight (body mass index > 25 mg/kg²), for example, Vietnam, the likelihood of death from COVID-19 is a small fraction – around one-tenth – of the level seen in countries where more than half the population is classified as overweight.

And while it acknowledges that figures for COVID-19 deaths are affected by the age structure of national populations and a country’s relative wealth and reporting capacity, “our findings appear to be independent of these contributory factors. Furthermore, other studies have found that overweight remains a highly significant predictor of the need for COVID-19 health care after accounting for these other influences.”

As an example, based on the U.K. experience, where an estimated 36% of COVID-19 hospitalizations have been attributed to lack of physical activity and excess body weight, it can be suggested that up to a third of the costs – between $6 trillion and $7 trillion over the longer period – might be attributable to these predisposing risks.

The report said the prevalence of obesity in the United Kingdom is expected to rise from 27.8% in 2016 to more than 35% by 2025.

Rachel Batterham, lead adviser on obesity at the Royal College of Physicians, commented: “The link between high levels of obesity and deaths from COVID-19 in the U.K. is indisputable, as is the urgent need to address the factors that lead so many people to be living with obesity.

“With 30% of COVID-19 hospitalizations in the U.K. directly attributed to overweight and obesity, and three-quarters of all critically ill patients having overweight or obesity, the human and financial costs are high.”
 

Window of opportunity to prioritize obesity as a disease

WOF says that evolving evidence on the close association between COVID-19 and underlying obesity “provides a new urgency … for political and collective action.”

“Obesity is a disease that does not receive prioritization commensurate with its prevalence and impact, which is rising fastest in emerging economies. It is a gateway to many other noncommunicable diseases and mental-health illness and is now a major factor in COVID-19 complications and mortality.”

The WOF also shows that COVID-19 is not a special case, noting that several other respiratory viruses lead to more severe consequences in people living with excess bodyweight, giving good reasons to expect the next pandemic to have similar effects. “For these reasons we need to recognize overweight as a major risk factor for infectious diseases including respiratory viruses.”

“To prevent pandemic health crises in future requires action now: we call on all readers to support the World Obesity Federation’s call for stronger, more resilient economies that prioritize investment in people’s health.”

There is, it stresses, “a window of opportunity to advocate for, fund and implement these actions in all countries to ensure better, more resilient and sustainable health for all, “now and in our postCOVID-19 future.”

It proposes a ROOTS approach:

• Recognize that obesity is a disease in its own right.
• Obesity monitoring and surveillance must be enhanced.
• Obesity prevention strategies must be developed.
• Treatment of obesity.
• Systems-based approaches should be applied.

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

Hundreds of thousands of deaths worldwide from COVID-19 could have been avoided if obesity rates were lower, a new report says.

An analysis by the World Obesity Federation found that of the 2.5 million COVID-19 deaths reported by the end of February 2021, almost 90% (2.2 million) were in countries where more than half the population is classified as overweight.

The report, released to coincide with World Obesity Day, calls for obesity to be recognized as a disease in its own right around the world, and for people with obesity to be included in priority lists for COVID-19 testing and vaccination.

“Overweight is a highly significant predictor of developing complications from COVID-19, including the need for hospitalization, for intensive care and for mechanical ventilation,” the WOF notes in the report.

It adds that in countries where less than half the adult population is classified as overweight (body mass index > 25 mg/kg²), for example, Vietnam, the likelihood of death from COVID-19 is a small fraction – around one-tenth – of the level seen in countries where more than half the population is classified as overweight.

And while it acknowledges that figures for COVID-19 deaths are affected by the age structure of national populations and a country’s relative wealth and reporting capacity, “our findings appear to be independent of these contributory factors. Furthermore, other studies have found that overweight remains a highly significant predictor of the need for COVID-19 health care after accounting for these other influences.”

As an example, based on the U.K. experience, where an estimated 36% of COVID-19 hospitalizations have been attributed to lack of physical activity and excess body weight, it can be suggested that up to a third of the costs – between $6 trillion and $7 trillion over the longer period – might be attributable to these predisposing risks.

The report said the prevalence of obesity in the United Kingdom is expected to rise from 27.8% in 2016 to more than 35% by 2025.

Rachel Batterham, lead adviser on obesity at the Royal College of Physicians, commented: “The link between high levels of obesity and deaths from COVID-19 in the U.K. is indisputable, as is the urgent need to address the factors that lead so many people to be living with obesity.

“With 30% of COVID-19 hospitalizations in the U.K. directly attributed to overweight and obesity, and three-quarters of all critically ill patients having overweight or obesity, the human and financial costs are high.”
 

Window of opportunity to prioritize obesity as a disease

WOF says that evolving evidence on the close association between COVID-19 and underlying obesity “provides a new urgency … for political and collective action.”

“Obesity is a disease that does not receive prioritization commensurate with its prevalence and impact, which is rising fastest in emerging economies. It is a gateway to many other noncommunicable diseases and mental-health illness and is now a major factor in COVID-19 complications and mortality.”

The WOF also shows that COVID-19 is not a special case, noting that several other respiratory viruses lead to more severe consequences in people living with excess bodyweight, giving good reasons to expect the next pandemic to have similar effects. “For these reasons we need to recognize overweight as a major risk factor for infectious diseases including respiratory viruses.”

“To prevent pandemic health crises in future requires action now: we call on all readers to support the World Obesity Federation’s call for stronger, more resilient economies that prioritize investment in people’s health.”

There is, it stresses, “a window of opportunity to advocate for, fund and implement these actions in all countries to ensure better, more resilient and sustainable health for all, “now and in our postCOVID-19 future.”

It proposes a ROOTS approach:

• Recognize that obesity is a disease in its own right.
• Obesity monitoring and surveillance must be enhanced.
• Obesity prevention strategies must be developed.
• Treatment of obesity.
• Systems-based approaches should be applied.

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

Hundreds of thousands of deaths worldwide from COVID-19 could have been avoided if obesity rates were lower, a new report says.

An analysis by the World Obesity Federation found that of the 2.5 million COVID-19 deaths reported by the end of February 2021, almost 90% (2.2 million) were in countries where more than half the population is classified as overweight.

The report, released to coincide with World Obesity Day, calls for obesity to be recognized as a disease in its own right around the world, and for people with obesity to be included in priority lists for COVID-19 testing and vaccination.

“Overweight is a highly significant predictor of developing complications from COVID-19, including the need for hospitalization, for intensive care and for mechanical ventilation,” the WOF notes in the report.

It adds that in countries where less than half the adult population is classified as overweight (body mass index > 25 mg/kg²), for example, Vietnam, the likelihood of death from COVID-19 is a small fraction – around one-tenth – of the level seen in countries where more than half the population is classified as overweight.

And while it acknowledges that figures for COVID-19 deaths are affected by the age structure of national populations and a country’s relative wealth and reporting capacity, “our findings appear to be independent of these contributory factors. Furthermore, other studies have found that overweight remains a highly significant predictor of the need for COVID-19 health care after accounting for these other influences.”

As an example, based on the U.K. experience, where an estimated 36% of COVID-19 hospitalizations have been attributed to lack of physical activity and excess body weight, it can be suggested that up to a third of the costs – between $6 trillion and $7 trillion over the longer period – might be attributable to these predisposing risks.

The report said the prevalence of obesity in the United Kingdom is expected to rise from 27.8% in 2016 to more than 35% by 2025.

Rachel Batterham, lead adviser on obesity at the Royal College of Physicians, commented: “The link between high levels of obesity and deaths from COVID-19 in the U.K. is indisputable, as is the urgent need to address the factors that lead so many people to be living with obesity.

“With 30% of COVID-19 hospitalizations in the U.K. directly attributed to overweight and obesity, and three-quarters of all critically ill patients having overweight or obesity, the human and financial costs are high.”
 

Window of opportunity to prioritize obesity as a disease

WOF says that evolving evidence on the close association between COVID-19 and underlying obesity “provides a new urgency … for political and collective action.”

“Obesity is a disease that does not receive prioritization commensurate with its prevalence and impact, which is rising fastest in emerging economies. It is a gateway to many other noncommunicable diseases and mental-health illness and is now a major factor in COVID-19 complications and mortality.”

The WOF also shows that COVID-19 is not a special case, noting that several other respiratory viruses lead to more severe consequences in people living with excess bodyweight, giving good reasons to expect the next pandemic to have similar effects. “For these reasons we need to recognize overweight as a major risk factor for infectious diseases including respiratory viruses.”

“To prevent pandemic health crises in future requires action now: we call on all readers to support the World Obesity Federation’s call for stronger, more resilient economies that prioritize investment in people’s health.”

There is, it stresses, “a window of opportunity to advocate for, fund and implement these actions in all countries to ensure better, more resilient and sustainable health for all, “now and in our postCOVID-19 future.”

It proposes a ROOTS approach:

• Recognize that obesity is a disease in its own right.
• Obesity monitoring and surveillance must be enhanced.
• Obesity prevention strategies must be developed.
• Treatment of obesity.
• Systems-based approaches should be applied.

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

Nostrum Laboratories has voluntarily recalled another lot of metformin HCl extended-release tablets 750-mg dosage, expanding their initial announcement in November 2020. According to the new notice, issued by the Food and Drug Administration earlier this week, the recalled tablets are off-white and oblong with a debossed ID “NM7.”

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The lot number, NDC, and expiration dates can be found on the FDA website.

Nostrum noted that the tablets were distributed across the United States to wholesalers; these distributors are being notified of the recall and the company is arranging for the drug to be returned.

Metformin is the most prescribed medication worldwide for the treatment of type 2 diabetes.

Nostrum said that anyone in possession of any of the affected lots should consult their physician or pharmacist to obtain a replacement treatment option because it can be dangerous for patients with type 2 diabetes to stop taking metformin.

This new announcement expands further the number of metformin HCl extended-release tablets recalled in the United States because they contain potentially high levels of nitrosamines, also known as N-nitrosodimethylamine (NDMA), which are possible carcinogens.

The risks of nitrosamines are not clear. The FDA said they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”

As well as the November recall of 2 lots of metformin by Nostrum, 76 more lots of metformin extended-release tablets were flagged in October 2020 from various manufacturers for possible contamination with NDMA, on top of an earlier recall for the same problem in May 2020.

More than 175 different drug combinations, all extended release with either 500 mg or 750 mg of metformin, have now been recalled since late May 2020, and a list of those recalled to November 2020 is available here.

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

Nostrum Laboratories has voluntarily recalled another lot of metformin HCl extended-release tablets 750-mg dosage, expanding their initial announcement in November 2020. According to the new notice, issued by the Food and Drug Administration earlier this week, the recalled tablets are off-white and oblong with a debossed ID “NM7.”

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The lot number, NDC, and expiration dates can be found on the FDA website.

Nostrum noted that the tablets were distributed across the United States to wholesalers; these distributors are being notified of the recall and the company is arranging for the drug to be returned.

Metformin is the most prescribed medication worldwide for the treatment of type 2 diabetes.

Nostrum said that anyone in possession of any of the affected lots should consult their physician or pharmacist to obtain a replacement treatment option because it can be dangerous for patients with type 2 diabetes to stop taking metformin.

This new announcement expands further the number of metformin HCl extended-release tablets recalled in the United States because they contain potentially high levels of nitrosamines, also known as N-nitrosodimethylamine (NDMA), which are possible carcinogens.

The risks of nitrosamines are not clear. The FDA said they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”

As well as the November recall of 2 lots of metformin by Nostrum, 76 more lots of metformin extended-release tablets were flagged in October 2020 from various manufacturers for possible contamination with NDMA, on top of an earlier recall for the same problem in May 2020.

More than 175 different drug combinations, all extended release with either 500 mg or 750 mg of metformin, have now been recalled since late May 2020, and a list of those recalled to November 2020 is available here.

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

Nostrum Laboratories has voluntarily recalled another lot of metformin HCl extended-release tablets 750-mg dosage, expanding their initial announcement in November 2020. According to the new notice, issued by the Food and Drug Administration earlier this week, the recalled tablets are off-white and oblong with a debossed ID “NM7.”

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The lot number, NDC, and expiration dates can be found on the FDA website.

Nostrum noted that the tablets were distributed across the United States to wholesalers; these distributors are being notified of the recall and the company is arranging for the drug to be returned.

Metformin is the most prescribed medication worldwide for the treatment of type 2 diabetes.

Nostrum said that anyone in possession of any of the affected lots should consult their physician or pharmacist to obtain a replacement treatment option because it can be dangerous for patients with type 2 diabetes to stop taking metformin.

This new announcement expands further the number of metformin HCl extended-release tablets recalled in the United States because they contain potentially high levels of nitrosamines, also known as N-nitrosodimethylamine (NDMA), which are possible carcinogens.

The risks of nitrosamines are not clear. The FDA said they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”

As well as the November recall of 2 lots of metformin by Nostrum, 76 more lots of metformin extended-release tablets were flagged in October 2020 from various manufacturers for possible contamination with NDMA, on top of an earlier recall for the same problem in May 2020.

More than 175 different drug combinations, all extended release with either 500 mg or 750 mg of metformin, have now been recalled since late May 2020, and a list of those recalled to November 2020 is available here.

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

It is becoming increasingly clear that obesity is one of the biggest risk factors for severe COVID-19 disease, particularly among younger patients.

Newly published data from New York show that, among those aged under 60 years, obesity was twice as likely to result in hospitalization for COVID-19 and also significantly increased the likelihood that a person would end up in intensive care.

“Obesity [in people younger than 60] appears to be a previously unrecognized risk factor for hospital admission and need for critical care. This has important and practical implications when nearly 40% of adults in the U.S. are obese with a body mass index [BMI] of [at least] 30,” wrote Jennifer Lighter, MD, of New York University Langone Health, and colleagues in their research letter published in Clinical Infectious Diseases.

Similar findings in a preprint publication, yet to be peer reviewed, from another New York hospital show that, with the exception of older age, obesity (BMI greater than 40 kg/m²) had the strongest association with hospitalization for COVID-19, increasing the risk more than 500%.

Meanwhile, a new French study shows a high frequency of obesity among patients admitted to one ICU for COVID-19; furthermore, disease severity increased with increasing BMI. One of the authors said in an interview that many of the presenting patients were younger, with their only risk factor being obesity.

“Patients with obesity should avoid any COVID-19 contamination by enforcing all prevention measures during the current pandemic,” wrote the authors, led by Arthur Simonnet, MD, Centre Hospitalier Universitaire de Lille (France).

They also stressed that COVID-19 patients “with severe obesity should be monitored more closely.”
 

Those with obesity are young and become very sick, very quickly

François Pattou, MD, PhD, coauthor of the French article published in Obesity said in an interview that, when patients with COVID-19 began to arrive at their ICU in Lille, there were young patients who did not have any other comorbidities.

“They were just obese,” he observed, adding that they seemed “to have a very specific disease, something different” from that seen before, with patients becoming very sick, very quickly.

In their study, they examined 124 consecutive patients admitted to intensive care with COVID-19 between Feb. 25 and April 5, 2020, and compared them with a historical control group of 306 patients admitted to the ICU at the same hospital for non–COVID-19-related severe acute respiratory disease in 2019.

By April 6, 60 patients with COVID-19 had been discharged from intensive care, 18 had died, and 46 remained in the unit. The majority (73%) were male, and their median age was 60 years. Obesity and severe obesity were significantly more prevalent among the patients with COVID-19, at 47.6% and 28.2% versus 25.2% and 10.8% among historical controls (P < .001 for trend).

A key finding was that those with a BMI greater than 35 had a more than 600% increased risk of requiring mechanical ventilation (odds ratio, 7.36; P = .021), compared with those with a BMI less than 25, even after adjusting for age, diabetes, and hypertension.
 

Obesity in under 60s at least doubles risk of admission in U.S.

The studies out of New York, one of which was stratified by age, paint a similar picture.

Dr. Lighter and colleagues found that, of the 3,615 individuals who tested positive for COVID-19 in their series, 775 (21%) had a BMI of 30-34 and 595 (16%) had a BMI of at least 35. Obesity wasn’t a predictor of admission to hospital or the ICU in those over the age of 60 years, but in those younger than 60 years, it was.

Those under age 60 with a BMI of 30-34 were twice as likely to be admitted to hospital (hazard ratio, 2.0; P < .0001) and critical care (HR, 1.8; P = .006), compared with those under age 60 with a BMI less than 30. Likewise, those under age 60 with a BMI of at least 35 were 2.2 (P < .0001) and 3.6 (P < .0001) times more likely to be admitted to acute and critical care.

“Unfortunately, obesity in people [less than] 60 years is a newly identified epidemiologic risk factor which may contribute to increased morbidity rates [with COVID-19] experienced in the U.S.,” they concluded.

And in the other U.S. study, Christopher M. Petrilli, MD, of New York University, and colleagues looked at 4,103 patients with COVID-19 treated between March 1 and April 2, 2020, and followed to April 7.

Just under half of patients (48.7%) were hospitalized, of whom 22.3% required mechanical ventilation and 14.6% died or were discharged to hospice. The research was published on medRxiv, showing that, apart from age, the strongest predictors of hospitalization were BMI greater than 40 (OR, 6.2) and heart failure (OR, 4.3).

“It is notable that the chronic condition with the strongest association with critical illness was obesity, with a substantially higher odds ratio than any cardiovascular or pulmonary disease,” they noted.
 

Inflammation is a possible culprit

Dr. Pattou believes that the culprit behind the increased risk of disease severity seen with obesity in COVID-19 is inflammation, mediated by fibrin deposits in the circulation, which his colleagues have seen on autopsy, and which “block oxygen passage through the blood.”

This may help explain why mechanical ventilation can be less successful in these patients. “The answer is to get rid of this inflammation,” Dr. Pattou observed.

Dr. Petrilli and colleagues also observed that obesity “is well-recognized to be a proinflammatory condition.”

And their findings showed “the importance of inflammatory markers in distinguishing future critical from noncritical illness,” they said, noting that, among these markers, early elevations in C-reactive protein and D-dimer “had the strongest association with mechanical ventilation or mortality.”

Livio Luzi, MD, of IRCCS MultiMedica, Milan, Italy, has previously written on the relationship between influenza and obesity, and discussed in an interview the potential lessons for the COVID-19 pandemic.

“Obesity is characterized by an impairment of immune response and by a low-grade chronic inflammation. Furthermore, obese subjects have an altered dynamic of pulmonary ventilation, with reduced diaphragmatic excursion,” Dr. Luzi said. These factors, alongside others, “may help to explain” the current results, and stress the importance of close monitoring of those with obesity and COVID-19.

No relevant financial relationships were declared.

This article first appeared on Medscape.com.

It is becoming increasingly clear that obesity is one of the biggest risk factors for severe COVID-19 disease, particularly among younger patients.

Newly published data from New York show that, among those aged under 60 years, obesity was twice as likely to result in hospitalization for COVID-19 and also significantly increased the likelihood that a person would end up in intensive care.

“Obesity [in people younger than 60] appears to be a previously unrecognized risk factor for hospital admission and need for critical care. This has important and practical implications when nearly 40% of adults in the U.S. are obese with a body mass index [BMI] of [at least] 30,” wrote Jennifer Lighter, MD, of New York University Langone Health, and colleagues in their research letter published in Clinical Infectious Diseases.

Similar findings in a preprint publication, yet to be peer reviewed, from another New York hospital show that, with the exception of older age, obesity (BMI greater than 40 kg/m²) had the strongest association with hospitalization for COVID-19, increasing the risk more than 500%.

Meanwhile, a new French study shows a high frequency of obesity among patients admitted to one ICU for COVID-19; furthermore, disease severity increased with increasing BMI. One of the authors said in an interview that many of the presenting patients were younger, with their only risk factor being obesity.

“Patients with obesity should avoid any COVID-19 contamination by enforcing all prevention measures during the current pandemic,” wrote the authors, led by Arthur Simonnet, MD, Centre Hospitalier Universitaire de Lille (France).

They also stressed that COVID-19 patients “with severe obesity should be monitored more closely.”
 

Those with obesity are young and become very sick, very quickly

François Pattou, MD, PhD, coauthor of the French article published in Obesity said in an interview that, when patients with COVID-19 began to arrive at their ICU in Lille, there were young patients who did not have any other comorbidities.

“They were just obese,” he observed, adding that they seemed “to have a very specific disease, something different” from that seen before, with patients becoming very sick, very quickly.

In their study, they examined 124 consecutive patients admitted to intensive care with COVID-19 between Feb. 25 and April 5, 2020, and compared them with a historical control group of 306 patients admitted to the ICU at the same hospital for non–COVID-19-related severe acute respiratory disease in 2019.

By April 6, 60 patients with COVID-19 had been discharged from intensive care, 18 had died, and 46 remained in the unit. The majority (73%) were male, and their median age was 60 years. Obesity and severe obesity were significantly more prevalent among the patients with COVID-19, at 47.6% and 28.2% versus 25.2% and 10.8% among historical controls (P < .001 for trend).

A key finding was that those with a BMI greater than 35 had a more than 600% increased risk of requiring mechanical ventilation (odds ratio, 7.36; P = .021), compared with those with a BMI less than 25, even after adjusting for age, diabetes, and hypertension.
 

Obesity in under 60s at least doubles risk of admission in U.S.

The studies out of New York, one of which was stratified by age, paint a similar picture.

Dr. Lighter and colleagues found that, of the 3,615 individuals who tested positive for COVID-19 in their series, 775 (21%) had a BMI of 30-34 and 595 (16%) had a BMI of at least 35. Obesity wasn’t a predictor of admission to hospital or the ICU in those over the age of 60 years, but in those younger than 60 years, it was.

Those under age 60 with a BMI of 30-34 were twice as likely to be admitted to hospital (hazard ratio, 2.0; P < .0001) and critical care (HR, 1.8; P = .006), compared with those under age 60 with a BMI less than 30. Likewise, those under age 60 with a BMI of at least 35 were 2.2 (P < .0001) and 3.6 (P < .0001) times more likely to be admitted to acute and critical care.

“Unfortunately, obesity in people [less than] 60 years is a newly identified epidemiologic risk factor which may contribute to increased morbidity rates [with COVID-19] experienced in the U.S.,” they concluded.

And in the other U.S. study, Christopher M. Petrilli, MD, of New York University, and colleagues looked at 4,103 patients with COVID-19 treated between March 1 and April 2, 2020, and followed to April 7.

Just under half of patients (48.7%) were hospitalized, of whom 22.3% required mechanical ventilation and 14.6% died or were discharged to hospice. The research was published on medRxiv, showing that, apart from age, the strongest predictors of hospitalization were BMI greater than 40 (OR, 6.2) and heart failure (OR, 4.3).

“It is notable that the chronic condition with the strongest association with critical illness was obesity, with a substantially higher odds ratio than any cardiovascular or pulmonary disease,” they noted.
 

Inflammation is a possible culprit

Dr. Pattou believes that the culprit behind the increased risk of disease severity seen with obesity in COVID-19 is inflammation, mediated by fibrin deposits in the circulation, which his colleagues have seen on autopsy, and which “block oxygen passage through the blood.”

This may help explain why mechanical ventilation can be less successful in these patients. “The answer is to get rid of this inflammation,” Dr. Pattou observed.

Dr. Petrilli and colleagues also observed that obesity “is well-recognized to be a proinflammatory condition.”

And their findings showed “the importance of inflammatory markers in distinguishing future critical from noncritical illness,” they said, noting that, among these markers, early elevations in C-reactive protein and D-dimer “had the strongest association with mechanical ventilation or mortality.”

Livio Luzi, MD, of IRCCS MultiMedica, Milan, Italy, has previously written on the relationship between influenza and obesity, and discussed in an interview the potential lessons for the COVID-19 pandemic.

“Obesity is characterized by an impairment of immune response and by a low-grade chronic inflammation. Furthermore, obese subjects have an altered dynamic of pulmonary ventilation, with reduced diaphragmatic excursion,” Dr. Luzi said. These factors, alongside others, “may help to explain” the current results, and stress the importance of close monitoring of those with obesity and COVID-19.

No relevant financial relationships were declared.

This article first appeared on Medscape.com.

It is becoming increasingly clear that obesity is one of the biggest risk factors for severe COVID-19 disease, particularly among younger patients.

Newly published data from New York show that, among those aged under 60 years, obesity was twice as likely to result in hospitalization for COVID-19 and also significantly increased the likelihood that a person would end up in intensive care.

“Obesity [in people younger than 60] appears to be a previously unrecognized risk factor for hospital admission and need for critical care. This has important and practical implications when nearly 40% of adults in the U.S. are obese with a body mass index [BMI] of [at least] 30,” wrote Jennifer Lighter, MD, of New York University Langone Health, and colleagues in their research letter published in Clinical Infectious Diseases.

Similar findings in a preprint publication, yet to be peer reviewed, from another New York hospital show that, with the exception of older age, obesity (BMI greater than 40 kg/m²) had the strongest association with hospitalization for COVID-19, increasing the risk more than 500%.

Meanwhile, a new French study shows a high frequency of obesity among patients admitted to one ICU for COVID-19; furthermore, disease severity increased with increasing BMI. One of the authors said in an interview that many of the presenting patients were younger, with their only risk factor being obesity.

“Patients with obesity should avoid any COVID-19 contamination by enforcing all prevention measures during the current pandemic,” wrote the authors, led by Arthur Simonnet, MD, Centre Hospitalier Universitaire de Lille (France).

They also stressed that COVID-19 patients “with severe obesity should be monitored more closely.”
 

Those with obesity are young and become very sick, very quickly

François Pattou, MD, PhD, coauthor of the French article published in Obesity said in an interview that, when patients with COVID-19 began to arrive at their ICU in Lille, there were young patients who did not have any other comorbidities.

“They were just obese,” he observed, adding that they seemed “to have a very specific disease, something different” from that seen before, with patients becoming very sick, very quickly.

In their study, they examined 124 consecutive patients admitted to intensive care with COVID-19 between Feb. 25 and April 5, 2020, and compared them with a historical control group of 306 patients admitted to the ICU at the same hospital for non–COVID-19-related severe acute respiratory disease in 2019.

By April 6, 60 patients with COVID-19 had been discharged from intensive care, 18 had died, and 46 remained in the unit. The majority (73%) were male, and their median age was 60 years. Obesity and severe obesity were significantly more prevalent among the patients with COVID-19, at 47.6% and 28.2% versus 25.2% and 10.8% among historical controls (P < .001 for trend).

A key finding was that those with a BMI greater than 35 had a more than 600% increased risk of requiring mechanical ventilation (odds ratio, 7.36; P = .021), compared with those with a BMI less than 25, even after adjusting for age, diabetes, and hypertension.
 

Obesity in under 60s at least doubles risk of admission in U.S.

The studies out of New York, one of which was stratified by age, paint a similar picture.

Dr. Lighter and colleagues found that, of the 3,615 individuals who tested positive for COVID-19 in their series, 775 (21%) had a BMI of 30-34 and 595 (16%) had a BMI of at least 35. Obesity wasn’t a predictor of admission to hospital or the ICU in those over the age of 60 years, but in those younger than 60 years, it was.

Those under age 60 with a BMI of 30-34 were twice as likely to be admitted to hospital (hazard ratio, 2.0; P < .0001) and critical care (HR, 1.8; P = .006), compared with those under age 60 with a BMI less than 30. Likewise, those under age 60 with a BMI of at least 35 were 2.2 (P < .0001) and 3.6 (P < .0001) times more likely to be admitted to acute and critical care.

“Unfortunately, obesity in people [less than] 60 years is a newly identified epidemiologic risk factor which may contribute to increased morbidity rates [with COVID-19] experienced in the U.S.,” they concluded.

And in the other U.S. study, Christopher M. Petrilli, MD, of New York University, and colleagues looked at 4,103 patients with COVID-19 treated between March 1 and April 2, 2020, and followed to April 7.

Just under half of patients (48.7%) were hospitalized, of whom 22.3% required mechanical ventilation and 14.6% died or were discharged to hospice. The research was published on medRxiv, showing that, apart from age, the strongest predictors of hospitalization were BMI greater than 40 (OR, 6.2) and heart failure (OR, 4.3).

“It is notable that the chronic condition with the strongest association with critical illness was obesity, with a substantially higher odds ratio than any cardiovascular or pulmonary disease,” they noted.
 

Inflammation is a possible culprit

Dr. Pattou believes that the culprit behind the increased risk of disease severity seen with obesity in COVID-19 is inflammation, mediated by fibrin deposits in the circulation, which his colleagues have seen on autopsy, and which “block oxygen passage through the blood.”

This may help explain why mechanical ventilation can be less successful in these patients. “The answer is to get rid of this inflammation,” Dr. Pattou observed.

Dr. Petrilli and colleagues also observed that obesity “is well-recognized to be a proinflammatory condition.”

And their findings showed “the importance of inflammatory markers in distinguishing future critical from noncritical illness,” they said, noting that, among these markers, early elevations in C-reactive protein and D-dimer “had the strongest association with mechanical ventilation or mortality.”

Livio Luzi, MD, of IRCCS MultiMedica, Milan, Italy, has previously written on the relationship between influenza and obesity, and discussed in an interview the potential lessons for the COVID-19 pandemic.

“Obesity is characterized by an impairment of immune response and by a low-grade chronic inflammation. Furthermore, obese subjects have an altered dynamic of pulmonary ventilation, with reduced diaphragmatic excursion,” Dr. Luzi said. These factors, alongside others, “may help to explain” the current results, and stress the importance of close monitoring of those with obesity and COVID-19.

No relevant financial relationships were declared.

This article first appeared on Medscape.com.

Reports from pediatric endocrinologists in COVID-19 hot spots globally indicate that children, adolescents, and young adults with diabetes have so far not shown a different disease pattern with the virus compared to children and younger people who do not have diabetes.

Indeed, colleagues in Wuhan, China, and Italy “state they have not had cases of COVID-19 in children, adolescents, or young adults less than 25 years of age with diabetes who required hospitalization, to date [as of March 24]” according to a new statement from the International Society for Pediatric and Adolescent Diabetes (ISPAD), which currently has about 1,300 members around the globe and has instituted a discussion forum about the topic of treating children with both diabetes and COVID-19.

“We find these reports [from colleagues around the world], though anecdotal, to be reassuring,” it notes. However, there are real worries regarding other potentially dangerous effects. ISPAD has expressed concern, for example, that the COVID-19 pandemic will prevent youngsters with existing diabetes who are having diabetic emergencies from seeking hospital care.

Chinese physicians have reported to ISPAD a number of cases of delayed hospital admissions for diabetic ketoacidosis (DKA) in children with known type 1 diabetes because hospital services were closed for non–COVID-19 care.

Andrea Scaramuzza, MD, a pediatric endocrinologist at Ospedale Maggiore di Cremona, Italy, has similarly reported multiple cases of patients presenting to emergency services there with severe DKA.

“These experiences reinforce the importance of continued attentiveness to standard diabetes care to avoid the need for hospitalization and emergency or urgent care visits,” says ISPAD, under the strapline: “Keep calm and mind your diabetes care.”

But it nevertheless stresses that these resources should be used “if needed.”
 

Worries that new-onset diabetes will be missed during COVID-19

Dr. Scaramuzza said in an interview that there also are concerns regarding delays in diagnoses of new cases of type 1 diabetes “due to the fear families have to go to the emergency department because of COVID-19.”

Indeed, in Italy, a few patients have arrived with very serious DKA, he said. Dr. Scaramuzza noted a colleague from Naples, Dario Iafusco, MD, and colleagues have made a video to keep awareness high regarding new-onset diabetes.

“This coronavirus pandemic can be defeated if you stay at home, but if you know of a child who has excessive thirst, frequent urination, or who starts vomiting,” seek health care advice immediately. “This child could have [type 1] diabetes. Prevent severe DKA, or worse, death,” Dr. Iafusco of the Regional Centre of Paediatric Diabetology G.Stoppoloni Via S. Andrea delle Dame, Naples, said in the video.

Physicians from China have similar observations, reporting to ISPAD several cases of delayed admissions of newly diagnosed type 1 diabetes because hospital services were closed for non–COVID-19 care.
 

Keep calm and mind your diabetes care; physicians use telemedicine

Meanwhile, last week ISPAD issued guidance for young people with diabetes and their carers about what to do if COVID-19 infection is suspected.

Most advice is the same as for the general public because reports of COVID-19 infection suggest it is much less severe in children and adolescents, and the summary currently serves “as reassurance that youth with diabetes are not more affected by COVID-19 than peers,” it adds.

“Our approach to treating a child with diabetes would be to follow the ISPAD sick-day guidelines, which provide generalized diabetes management in any flu-like illness. We wouldn’t do anything very different right now,” one of the authors, Jamie Wood, MD, associate professor of clinical pediatrics at Case Western Reserve University, Cleveland, said in an interview.

“Any illness makes diabetes more difficult to manage and can increase the risk of DKA,” she emphasized.

“We would reinforce frequent monitoring of blood glucose and ketone levels, to never stop insulin – in fact, when most people are ill, the body is stressed and requires more insulin – and to stay hydrated and treat the underlying symptoms.”

And make sure to “treat the fever,” she stressed. “When patients with type 1 diabetes get fever, they have a tendency to make more ketones, so we recommend aggressive control of fever.”

ISPAD recommends young people aim to keep blood glucose levels between 4 and 10 mmol/L (72-180 mg/dL) and blood ketones below 0.6 mmol/L (10.8 mg/dL) during illness and to never stop insulin.

Guidance is provided on when to seek urgent specialist advice with possible referral to emergency care, for example, in cases in which the patient has DKA symptoms, such as persistent and/or worsened fruity breath odor or vomiting.

Dr. Scaramuzza said in an interview that, in Italy, he and his colleagues have increased their use of telemedicine to keep monitoring their patients with diabetes even from a distance and that it was working very well.

“Technology – such as downloading [records from] insulin pumps, continuous glucose monitoring systems, and the possibility to use Skype or other platforms – really helps,” he noted.

“There has been a rapid increase in telehealth as a way to continue to care for youth with diabetes and decrease risk for infection,” said ISPAD.

“Communication between patients, families, and health care teams is vitally important. Methods to do so that avoid visits to clinics or hospitals can provide needed diabetes advice and reduce risk for COVID-19 transmission.”

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

Reports from pediatric endocrinologists in COVID-19 hot spots globally indicate that children, adolescents, and young adults with diabetes have so far not shown a different disease pattern with the virus compared to children and younger people who do not have diabetes.

Indeed, colleagues in Wuhan, China, and Italy “state they have not had cases of COVID-19 in children, adolescents, or young adults less than 25 years of age with diabetes who required hospitalization, to date [as of March 24]” according to a new statement from the International Society for Pediatric and Adolescent Diabetes (ISPAD), which currently has about 1,300 members around the globe and has instituted a discussion forum about the topic of treating children with both diabetes and COVID-19.

“We find these reports [from colleagues around the world], though anecdotal, to be reassuring,” it notes. However, there are real worries regarding other potentially dangerous effects. ISPAD has expressed concern, for example, that the COVID-19 pandemic will prevent youngsters with existing diabetes who are having diabetic emergencies from seeking hospital care.

Chinese physicians have reported to ISPAD a number of cases of delayed hospital admissions for diabetic ketoacidosis (DKA) in children with known type 1 diabetes because hospital services were closed for non–COVID-19 care.

Andrea Scaramuzza, MD, a pediatric endocrinologist at Ospedale Maggiore di Cremona, Italy, has similarly reported multiple cases of patients presenting to emergency services there with severe DKA.

“These experiences reinforce the importance of continued attentiveness to standard diabetes care to avoid the need for hospitalization and emergency or urgent care visits,” says ISPAD, under the strapline: “Keep calm and mind your diabetes care.”

But it nevertheless stresses that these resources should be used “if needed.”
 

Worries that new-onset diabetes will be missed during COVID-19

Dr. Scaramuzza said in an interview that there also are concerns regarding delays in diagnoses of new cases of type 1 diabetes “due to the fear families have to go to the emergency department because of COVID-19.”

Indeed, in Italy, a few patients have arrived with very serious DKA, he said. Dr. Scaramuzza noted a colleague from Naples, Dario Iafusco, MD, and colleagues have made a video to keep awareness high regarding new-onset diabetes.

“This coronavirus pandemic can be defeated if you stay at home, but if you know of a child who has excessive thirst, frequent urination, or who starts vomiting,” seek health care advice immediately. “This child could have [type 1] diabetes. Prevent severe DKA, or worse, death,” Dr. Iafusco of the Regional Centre of Paediatric Diabetology G.Stoppoloni Via S. Andrea delle Dame, Naples, said in the video.

Physicians from China have similar observations, reporting to ISPAD several cases of delayed admissions of newly diagnosed type 1 diabetes because hospital services were closed for non–COVID-19 care.
 

Keep calm and mind your diabetes care; physicians use telemedicine

Meanwhile, last week ISPAD issued guidance for young people with diabetes and their carers about what to do if COVID-19 infection is suspected.

Most advice is the same as for the general public because reports of COVID-19 infection suggest it is much less severe in children and adolescents, and the summary currently serves “as reassurance that youth with diabetes are not more affected by COVID-19 than peers,” it adds.

“Our approach to treating a child with diabetes would be to follow the ISPAD sick-day guidelines, which provide generalized diabetes management in any flu-like illness. We wouldn’t do anything very different right now,” one of the authors, Jamie Wood, MD, associate professor of clinical pediatrics at Case Western Reserve University, Cleveland, said in an interview.

“Any illness makes diabetes more difficult to manage and can increase the risk of DKA,” she emphasized.

“We would reinforce frequent monitoring of blood glucose and ketone levels, to never stop insulin – in fact, when most people are ill, the body is stressed and requires more insulin – and to stay hydrated and treat the underlying symptoms.”

And make sure to “treat the fever,” she stressed. “When patients with type 1 diabetes get fever, they have a tendency to make more ketones, so we recommend aggressive control of fever.”

ISPAD recommends young people aim to keep blood glucose levels between 4 and 10 mmol/L (72-180 mg/dL) and blood ketones below 0.6 mmol/L (10.8 mg/dL) during illness and to never stop insulin.

Guidance is provided on when to seek urgent specialist advice with possible referral to emergency care, for example, in cases in which the patient has DKA symptoms, such as persistent and/or worsened fruity breath odor or vomiting.

Dr. Scaramuzza said in an interview that, in Italy, he and his colleagues have increased their use of telemedicine to keep monitoring their patients with diabetes even from a distance and that it was working very well.

“Technology – such as downloading [records from] insulin pumps, continuous glucose monitoring systems, and the possibility to use Skype or other platforms – really helps,” he noted.

“There has been a rapid increase in telehealth as a way to continue to care for youth with diabetes and decrease risk for infection,” said ISPAD.

“Communication between patients, families, and health care teams is vitally important. Methods to do so that avoid visits to clinics or hospitals can provide needed diabetes advice and reduce risk for COVID-19 transmission.”

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

Reports from pediatric endocrinologists in COVID-19 hot spots globally indicate that children, adolescents, and young adults with diabetes have so far not shown a different disease pattern with the virus compared to children and younger people who do not have diabetes.

Indeed, colleagues in Wuhan, China, and Italy “state they have not had cases of COVID-19 in children, adolescents, or young adults less than 25 years of age with diabetes who required hospitalization, to date [as of March 24]” according to a new statement from the International Society for Pediatric and Adolescent Diabetes (ISPAD), which currently has about 1,300 members around the globe and has instituted a discussion forum about the topic of treating children with both diabetes and COVID-19.

“We find these reports [from colleagues around the world], though anecdotal, to be reassuring,” it notes. However, there are real worries regarding other potentially dangerous effects. ISPAD has expressed concern, for example, that the COVID-19 pandemic will prevent youngsters with existing diabetes who are having diabetic emergencies from seeking hospital care.

Chinese physicians have reported to ISPAD a number of cases of delayed hospital admissions for diabetic ketoacidosis (DKA) in children with known type 1 diabetes because hospital services were closed for non–COVID-19 care.

Andrea Scaramuzza, MD, a pediatric endocrinologist at Ospedale Maggiore di Cremona, Italy, has similarly reported multiple cases of patients presenting to emergency services there with severe DKA.

“These experiences reinforce the importance of continued attentiveness to standard diabetes care to avoid the need for hospitalization and emergency or urgent care visits,” says ISPAD, under the strapline: “Keep calm and mind your diabetes care.”

But it nevertheless stresses that these resources should be used “if needed.”
 

Worries that new-onset diabetes will be missed during COVID-19

Dr. Scaramuzza said in an interview that there also are concerns regarding delays in diagnoses of new cases of type 1 diabetes “due to the fear families have to go to the emergency department because of COVID-19.”

Indeed, in Italy, a few patients have arrived with very serious DKA, he said. Dr. Scaramuzza noted a colleague from Naples, Dario Iafusco, MD, and colleagues have made a video to keep awareness high regarding new-onset diabetes.

“This coronavirus pandemic can be defeated if you stay at home, but if you know of a child who has excessive thirst, frequent urination, or who starts vomiting,” seek health care advice immediately. “This child could have [type 1] diabetes. Prevent severe DKA, or worse, death,” Dr. Iafusco of the Regional Centre of Paediatric Diabetology G.Stoppoloni Via S. Andrea delle Dame, Naples, said in the video.

Physicians from China have similar observations, reporting to ISPAD several cases of delayed admissions of newly diagnosed type 1 diabetes because hospital services were closed for non–COVID-19 care.
 

Keep calm and mind your diabetes care; physicians use telemedicine

Meanwhile, last week ISPAD issued guidance for young people with diabetes and their carers about what to do if COVID-19 infection is suspected.

Most advice is the same as for the general public because reports of COVID-19 infection suggest it is much less severe in children and adolescents, and the summary currently serves “as reassurance that youth with diabetes are not more affected by COVID-19 than peers,” it adds.

“Our approach to treating a child with diabetes would be to follow the ISPAD sick-day guidelines, which provide generalized diabetes management in any flu-like illness. We wouldn’t do anything very different right now,” one of the authors, Jamie Wood, MD, associate professor of clinical pediatrics at Case Western Reserve University, Cleveland, said in an interview.

“Any illness makes diabetes more difficult to manage and can increase the risk of DKA,” she emphasized.

“We would reinforce frequent monitoring of blood glucose and ketone levels, to never stop insulin – in fact, when most people are ill, the body is stressed and requires more insulin – and to stay hydrated and treat the underlying symptoms.”

And make sure to “treat the fever,” she stressed. “When patients with type 1 diabetes get fever, they have a tendency to make more ketones, so we recommend aggressive control of fever.”

ISPAD recommends young people aim to keep blood glucose levels between 4 and 10 mmol/L (72-180 mg/dL) and blood ketones below 0.6 mmol/L (10.8 mg/dL) during illness and to never stop insulin.

Guidance is provided on when to seek urgent specialist advice with possible referral to emergency care, for example, in cases in which the patient has DKA symptoms, such as persistent and/or worsened fruity breath odor or vomiting.

Dr. Scaramuzza said in an interview that, in Italy, he and his colleagues have increased their use of telemedicine to keep monitoring their patients with diabetes even from a distance and that it was working very well.

“Technology – such as downloading [records from] insulin pumps, continuous glucose monitoring systems, and the possibility to use Skype or other platforms – really helps,” he noted.

“There has been a rapid increase in telehealth as a way to continue to care for youth with diabetes and decrease risk for infection,” said ISPAD.

“Communication between patients, families, and health care teams is vitally important. Methods to do so that avoid visits to clinics or hospitals can provide needed diabetes advice and reduce risk for COVID-19 transmission.”

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

The Food and Drug Administration says it has no plans to recall any metformin products, used for the treatment of type 2 diabetes, after tests it conducted did not show any evidence of contamination with N-nitrosodimethylamine (NDMA) at levels that would cause concern.

The FDA began testing samples of metformin for the carcinogen NDMA at the end of 2019. Contamination with this substance has led to recalls of hypertension and heartburn medications within the past 2 years.

That announcement came on the heels of a recall of three versions of metformin in Singapore and the European Medicines Agency’s request that manufacturers test for NDMA.

This week, the FDA posted laboratory results in which NDMA levels in some metformin products ranged from “not detectable to low.”

“To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the U.S.,” the agency indicates.

More than 30 million people in the United States have diabetes; 90%-95% of cases are of type 2. Metformin is the fourth most prescribed drug in the United States.

“Patients should continue taking metformin to keep their diabetes under control,” the FDA emphasized. “It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.”

The agency plans to post the methods used in laboratory testing of metformin in the near future. The FDA is collaborating with international regulators to share testing results for metformin, along with testing results for other drugs.

The U.S. agency says it will continue to monitor NDMA in metformin, along with other drug products, and will provide timely updates of new developments, including product recalls.

For more information about NDMA, visit the FDA’s nitrosamines webpage.

The FDA also encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program.

This article first appeared on Medscape.com.

The Food and Drug Administration says it has no plans to recall any metformin products, used for the treatment of type 2 diabetes, after tests it conducted did not show any evidence of contamination with N-nitrosodimethylamine (NDMA) at levels that would cause concern.

The FDA began testing samples of metformin for the carcinogen NDMA at the end of 2019. Contamination with this substance has led to recalls of hypertension and heartburn medications within the past 2 years.

That announcement came on the heels of a recall of three versions of metformin in Singapore and the European Medicines Agency’s request that manufacturers test for NDMA.

This week, the FDA posted laboratory results in which NDMA levels in some metformin products ranged from “not detectable to low.”

“To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the U.S.,” the agency indicates.

More than 30 million people in the United States have diabetes; 90%-95% of cases are of type 2. Metformin is the fourth most prescribed drug in the United States.

“Patients should continue taking metformin to keep their diabetes under control,” the FDA emphasized. “It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.”

The agency plans to post the methods used in laboratory testing of metformin in the near future. The FDA is collaborating with international regulators to share testing results for metformin, along with testing results for other drugs.

The U.S. agency says it will continue to monitor NDMA in metformin, along with other drug products, and will provide timely updates of new developments, including product recalls.

For more information about NDMA, visit the FDA’s nitrosamines webpage.

The FDA also encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program.

This article first appeared on Medscape.com.

The Food and Drug Administration says it has no plans to recall any metformin products, used for the treatment of type 2 diabetes, after tests it conducted did not show any evidence of contamination with N-nitrosodimethylamine (NDMA) at levels that would cause concern.

The FDA began testing samples of metformin for the carcinogen NDMA at the end of 2019. Contamination with this substance has led to recalls of hypertension and heartburn medications within the past 2 years.

That announcement came on the heels of a recall of three versions of metformin in Singapore and the European Medicines Agency’s request that manufacturers test for NDMA.

This week, the FDA posted laboratory results in which NDMA levels in some metformin products ranged from “not detectable to low.”

“To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the U.S.,” the agency indicates.

More than 30 million people in the United States have diabetes; 90%-95% of cases are of type 2. Metformin is the fourth most prescribed drug in the United States.

“Patients should continue taking metformin to keep their diabetes under control,” the FDA emphasized. “It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.”

The agency plans to post the methods used in laboratory testing of metformin in the near future. The FDA is collaborating with international regulators to share testing results for metformin, along with testing results for other drugs.

The U.S. agency says it will continue to monitor NDMA in metformin, along with other drug products, and will provide timely updates of new developments, including product recalls.

For more information about NDMA, visit the FDA’s nitrosamines webpage.

The FDA also encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program.

This article first appeared on Medscape.com.