Clinical Psychiatry News

Young people with gender dysphoria should be considered as individuals rather than fall into an age-defined bracket when assessing their understanding to consent to hormone treatment, according to the Tavistock and Portman NHS Foundation Trust, as it awaits the verdict of its recent appeal in London against a High Court ruling. 

The High Court ruling, made in December 2020 as reported by this news organization, stated that adolescents with gender dysphoria were unlikely to fully understand the consequences of hormone treatment for gender reassignment and was the result of a case brought by 24-year-old Keira Bell, who transitioned from female to male at the Gender Identity Development Service (GIDS), starting at the age of 16, but later “detransitioned.”

Along with changes made to rules around prescribing puberty blockers and cross-sex hormones to minors with gender dysphoria in countries such as Finland and Sweden, the English ruling signals a more cautious approach to any medical treatment for such children, as detailed in a feature published in April.

However, during the appeal, The Trust argued once more that puberty blockers give children time to “consider options” about their bodies and that the decision (the December ruling) was inconsistent with the law that “entitles children under the age of 16 to make decisions for themselves after being assessed as competent to do so by their doctor.”

Alongside other organizations, the United States–based Endocrine Society submitted written evidence in support of the Tavistock. “The High Court’s decision, if it is allowed to stand, would set a harmful precedent preventing physicians from providing transgender and gender diverse youth with high-quality medical care,” it noted in a statement.

Defending the High Court’s ruling, the lawyer for Ms. Bell said its conclusion was that puberty blockers for gender dysphoria are an “experimental” treatment with a very limited evidence base.

“The judgment of the [High Court] is entirely correct, and there is no proper basis for overturning it,” he asserted.

The 2-day appeal hearing ended on June 24, and a ruling will be made at a later date.
 

Do children understand the consequences of hormone treatment?

One central aspect of the overall case is the fact that Ms. Bell regrets her decision to transition at age 16, saying she only received three counseling sessions prior to endocrinology referral. And she consequently had a mastectomy at age 20, which she also bitterly regrets.

So a key concern is whether young people fully understand the consequences of taking puberty blockers and therapies that may follow, including cross-sex hormones.

Witness for the appeal Gary Butler, MD, consultant in pediatric and adolescent endocrinology at University College Hospital, London, where children are referred to from GIDS for hormone treatment, said the number of children who go on to cross-sex hormones from puberty blockers is “over 80%.” 

But the actual number of children who are referred to endocrinology services (where puberty blockers are initiated) from GIDS is low, at approximately 16%, according to 2019-2020 data, said a GIDS spokesperson.

“Once at the endocrinology service, young people either participate in a group education session, or if under 15 years, an individualized session between the clinician and the patient and family members,” she added. The Trust also maintained that initiation of cross-sex hormones “is separate from the prescription of puberty blockers.”

Since the December ruling, The Trust has put in place multidisciplinary clinical reviews (MDCR) of cases, and in July, NHS England will start implementing an independent multidisciplinary professional review (MDPR) to check that the GIDS has followed due process with each case.
 

Slow the process down, give appropriate psychotherapy

Stella O’Malley is a psychotherapist who works with transitioners and detransitioners and is a founding member of the International Association of Therapists for Desisters and Detransitioners (IATDD).

Whatever the outcome of the appeal process, Ms. O’Malley said she would like to see the Tavistock slow down and take a broader approach to counseling children before referral to endocrinology services. 

In discussing therapy prior to transition, Ms. O’Malley stated that her clients often say they did not explore their inner motivations or other possible reasons for their distress, and the therapy was focused more on when they transition, rather than being sure it was something they wanted to do.

“We need to learn from the mistakes made with people like Keira Bell. Clinicians need to realize that fast-tracking counseling doesn’t work, especially when [children are] ... young and especially when they’re traumatized,” Ms. O’Malley said.

“Had they received a more conventional therapy, they might have thought about their decision from different perspectives and in the process acquired more self-awareness, which would have been more beneficial.” 

“The ‘affirmative’ approach to gender therapy is too narrow; we need to look at the whole individual. Therapy in other areas would never disregard other, nongender issues such as attention deficit hyperactivity disorder or anxiety [which often co-exist with gender dysphoria] – issues bleed into each other,” Ms. O’Malley pointed out. “We need a more exploratory approach.”  

“I’d also like to see other therapists all over the [U.K.] who are perfectly qualified and capable of working with gender actually start working with gender issues,” she said, noting that such an approach might also help reduce the long waiting list at the Tavistock.

The latter had been overwhelmed, and this led to a speeding up of the assessment process, which led to a number of professionals resigning from the service in recent years, saying children were being “fast-tracked” to medical transition.  
 

Fertility and sexual function are complex issues for kids

Also asked to comment was Claire Graham, from Genspect, a group that describes itself as a voice for parents of gender-questioning kids.

She told this news organization that “parents are rightly concerned about their children’s ability to consent to treatments that may lead to infertility and issues surrounding sexual function.” She added that other countries in Europe were changing their approach. “Look to Sweden and Finland, who have both rowed back on puberty blockers and no longer recommend them.”

Ms. Graham, who has worked with children with differences in sexual development, added that it was very difficult for children and young people to understand the life-long implications of decisions made at an early age.

“How can children understand what it is to live with impaired sexual functioning if they have never had sex? Likewise, fertility is a complex issue. Most people do not want to become parents as teenagers, but we understand that this will often change as they grow,” said Ms. Graham.

“Many parents worry that their child is not being considered in the whole [and] that their child’s ability to consent to medical interventions for gender dysphoria is impacted by comorbidities, such as a diagnosis of autism or a history of mental health issues. These children are particularly vulnerable.”

“At Genspect, we hope that the decision from the ... court is upheld,” Ms. Graham concluded.

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

Young people with gender dysphoria should be considered as individuals rather than fall into an age-defined bracket when assessing their understanding to consent to hormone treatment, according to the Tavistock and Portman NHS Foundation Trust, as it awaits the verdict of its recent appeal in London against a High Court ruling. 

The High Court ruling, made in December 2020 as reported by this news organization, stated that adolescents with gender dysphoria were unlikely to fully understand the consequences of hormone treatment for gender reassignment and was the result of a case brought by 24-year-old Keira Bell, who transitioned from female to male at the Gender Identity Development Service (GIDS), starting at the age of 16, but later “detransitioned.”

Along with changes made to rules around prescribing puberty blockers and cross-sex hormones to minors with gender dysphoria in countries such as Finland and Sweden, the English ruling signals a more cautious approach to any medical treatment for such children, as detailed in a feature published in April.

However, during the appeal, The Trust argued once more that puberty blockers give children time to “consider options” about their bodies and that the decision (the December ruling) was inconsistent with the law that “entitles children under the age of 16 to make decisions for themselves after being assessed as competent to do so by their doctor.”

Alongside other organizations, the United States–based Endocrine Society submitted written evidence in support of the Tavistock. “The High Court’s decision, if it is allowed to stand, would set a harmful precedent preventing physicians from providing transgender and gender diverse youth with high-quality medical care,” it noted in a statement.

Defending the High Court’s ruling, the lawyer for Ms. Bell said its conclusion was that puberty blockers for gender dysphoria are an “experimental” treatment with a very limited evidence base.

“The judgment of the [High Court] is entirely correct, and there is no proper basis for overturning it,” he asserted.

The 2-day appeal hearing ended on June 24, and a ruling will be made at a later date.
 

Do children understand the consequences of hormone treatment?

One central aspect of the overall case is the fact that Ms. Bell regrets her decision to transition at age 16, saying she only received three counseling sessions prior to endocrinology referral. And she consequently had a mastectomy at age 20, which she also bitterly regrets.

So a key concern is whether young people fully understand the consequences of taking puberty blockers and therapies that may follow, including cross-sex hormones.

Witness for the appeal Gary Butler, MD, consultant in pediatric and adolescent endocrinology at University College Hospital, London, where children are referred to from GIDS for hormone treatment, said the number of children who go on to cross-sex hormones from puberty blockers is “over 80%.” 

But the actual number of children who are referred to endocrinology services (where puberty blockers are initiated) from GIDS is low, at approximately 16%, according to 2019-2020 data, said a GIDS spokesperson.

“Once at the endocrinology service, young people either participate in a group education session, or if under 15 years, an individualized session between the clinician and the patient and family members,” she added. The Trust also maintained that initiation of cross-sex hormones “is separate from the prescription of puberty blockers.”

Since the December ruling, The Trust has put in place multidisciplinary clinical reviews (MDCR) of cases, and in July, NHS England will start implementing an independent multidisciplinary professional review (MDPR) to check that the GIDS has followed due process with each case.
 

Slow the process down, give appropriate psychotherapy

Stella O’Malley is a psychotherapist who works with transitioners and detransitioners and is a founding member of the International Association of Therapists for Desisters and Detransitioners (IATDD).

Whatever the outcome of the appeal process, Ms. O’Malley said she would like to see the Tavistock slow down and take a broader approach to counseling children before referral to endocrinology services. 

In discussing therapy prior to transition, Ms. O’Malley stated that her clients often say they did not explore their inner motivations or other possible reasons for their distress, and the therapy was focused more on when they transition, rather than being sure it was something they wanted to do.

“We need to learn from the mistakes made with people like Keira Bell. Clinicians need to realize that fast-tracking counseling doesn’t work, especially when [children are] ... young and especially when they’re traumatized,” Ms. O’Malley said.

“Had they received a more conventional therapy, they might have thought about their decision from different perspectives and in the process acquired more self-awareness, which would have been more beneficial.” 

“The ‘affirmative’ approach to gender therapy is too narrow; we need to look at the whole individual. Therapy in other areas would never disregard other, nongender issues such as attention deficit hyperactivity disorder or anxiety [which often co-exist with gender dysphoria] – issues bleed into each other,” Ms. O’Malley pointed out. “We need a more exploratory approach.”  

“I’d also like to see other therapists all over the [U.K.] who are perfectly qualified and capable of working with gender actually start working with gender issues,” she said, noting that such an approach might also help reduce the long waiting list at the Tavistock.

The latter had been overwhelmed, and this led to a speeding up of the assessment process, which led to a number of professionals resigning from the service in recent years, saying children were being “fast-tracked” to medical transition.  
 

Fertility and sexual function are complex issues for kids

Also asked to comment was Claire Graham, from Genspect, a group that describes itself as a voice for parents of gender-questioning kids.

She told this news organization that “parents are rightly concerned about their children’s ability to consent to treatments that may lead to infertility and issues surrounding sexual function.” She added that other countries in Europe were changing their approach. “Look to Sweden and Finland, who have both rowed back on puberty blockers and no longer recommend them.”

Ms. Graham, who has worked with children with differences in sexual development, added that it was very difficult for children and young people to understand the life-long implications of decisions made at an early age.

“How can children understand what it is to live with impaired sexual functioning if they have never had sex? Likewise, fertility is a complex issue. Most people do not want to become parents as teenagers, but we understand that this will often change as they grow,” said Ms. Graham.

“Many parents worry that their child is not being considered in the whole [and] that their child’s ability to consent to medical interventions for gender dysphoria is impacted by comorbidities, such as a diagnosis of autism or a history of mental health issues. These children are particularly vulnerable.”

“At Genspect, we hope that the decision from the ... court is upheld,” Ms. Graham concluded.

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

Young people with gender dysphoria should be considered as individuals rather than fall into an age-defined bracket when assessing their understanding to consent to hormone treatment, according to the Tavistock and Portman NHS Foundation Trust, as it awaits the verdict of its recent appeal in London against a High Court ruling. 

The High Court ruling, made in December 2020 as reported by this news organization, stated that adolescents with gender dysphoria were unlikely to fully understand the consequences of hormone treatment for gender reassignment and was the result of a case brought by 24-year-old Keira Bell, who transitioned from female to male at the Gender Identity Development Service (GIDS), starting at the age of 16, but later “detransitioned.”

Along with changes made to rules around prescribing puberty blockers and cross-sex hormones to minors with gender dysphoria in countries such as Finland and Sweden, the English ruling signals a more cautious approach to any medical treatment for such children, as detailed in a feature published in April.

However, during the appeal, The Trust argued once more that puberty blockers give children time to “consider options” about their bodies and that the decision (the December ruling) was inconsistent with the law that “entitles children under the age of 16 to make decisions for themselves after being assessed as competent to do so by their doctor.”

Alongside other organizations, the United States–based Endocrine Society submitted written evidence in support of the Tavistock. “The High Court’s decision, if it is allowed to stand, would set a harmful precedent preventing physicians from providing transgender and gender diverse youth with high-quality medical care,” it noted in a statement.

Defending the High Court’s ruling, the lawyer for Ms. Bell said its conclusion was that puberty blockers for gender dysphoria are an “experimental” treatment with a very limited evidence base.

“The judgment of the [High Court] is entirely correct, and there is no proper basis for overturning it,” he asserted.

The 2-day appeal hearing ended on June 24, and a ruling will be made at a later date.
 

Do children understand the consequences of hormone treatment?

One central aspect of the overall case is the fact that Ms. Bell regrets her decision to transition at age 16, saying she only received three counseling sessions prior to endocrinology referral. And she consequently had a mastectomy at age 20, which she also bitterly regrets.

So a key concern is whether young people fully understand the consequences of taking puberty blockers and therapies that may follow, including cross-sex hormones.

Witness for the appeal Gary Butler, MD, consultant in pediatric and adolescent endocrinology at University College Hospital, London, where children are referred to from GIDS for hormone treatment, said the number of children who go on to cross-sex hormones from puberty blockers is “over 80%.” 

But the actual number of children who are referred to endocrinology services (where puberty blockers are initiated) from GIDS is low, at approximately 16%, according to 2019-2020 data, said a GIDS spokesperson.

“Once at the endocrinology service, young people either participate in a group education session, or if under 15 years, an individualized session between the clinician and the patient and family members,” she added. The Trust also maintained that initiation of cross-sex hormones “is separate from the prescription of puberty blockers.”

Since the December ruling, The Trust has put in place multidisciplinary clinical reviews (MDCR) of cases, and in July, NHS England will start implementing an independent multidisciplinary professional review (MDPR) to check that the GIDS has followed due process with each case.
 

Slow the process down, give appropriate psychotherapy

Stella O’Malley is a psychotherapist who works with transitioners and detransitioners and is a founding member of the International Association of Therapists for Desisters and Detransitioners (IATDD).

Whatever the outcome of the appeal process, Ms. O’Malley said she would like to see the Tavistock slow down and take a broader approach to counseling children before referral to endocrinology services. 

In discussing therapy prior to transition, Ms. O’Malley stated that her clients often say they did not explore their inner motivations or other possible reasons for their distress, and the therapy was focused more on when they transition, rather than being sure it was something they wanted to do.

“We need to learn from the mistakes made with people like Keira Bell. Clinicians need to realize that fast-tracking counseling doesn’t work, especially when [children are] ... young and especially when they’re traumatized,” Ms. O’Malley said.

“Had they received a more conventional therapy, they might have thought about their decision from different perspectives and in the process acquired more self-awareness, which would have been more beneficial.” 

“The ‘affirmative’ approach to gender therapy is too narrow; we need to look at the whole individual. Therapy in other areas would never disregard other, nongender issues such as attention deficit hyperactivity disorder or anxiety [which often co-exist with gender dysphoria] – issues bleed into each other,” Ms. O’Malley pointed out. “We need a more exploratory approach.”  

“I’d also like to see other therapists all over the [U.K.] who are perfectly qualified and capable of working with gender actually start working with gender issues,” she said, noting that such an approach might also help reduce the long waiting list at the Tavistock.

The latter had been overwhelmed, and this led to a speeding up of the assessment process, which led to a number of professionals resigning from the service in recent years, saying children were being “fast-tracked” to medical transition.  
 

Fertility and sexual function are complex issues for kids

Also asked to comment was Claire Graham, from Genspect, a group that describes itself as a voice for parents of gender-questioning kids.

She told this news organization that “parents are rightly concerned about their children’s ability to consent to treatments that may lead to infertility and issues surrounding sexual function.” She added that other countries in Europe were changing their approach. “Look to Sweden and Finland, who have both rowed back on puberty blockers and no longer recommend them.”

Ms. Graham, who has worked with children with differences in sexual development, added that it was very difficult for children and young people to understand the life-long implications of decisions made at an early age.

“How can children understand what it is to live with impaired sexual functioning if they have never had sex? Likewise, fertility is a complex issue. Most people do not want to become parents as teenagers, but we understand that this will often change as they grow,” said Ms. Graham.

“Many parents worry that their child is not being considered in the whole [and] that their child’s ability to consent to medical interventions for gender dysphoria is impacted by comorbidities, such as a diagnosis of autism or a history of mental health issues. These children are particularly vulnerable.”

“At Genspect, we hope that the decision from the ... court is upheld,” Ms. Graham concluded.

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

Pop icon Britney Spears spoke out recently against the conservatorship that she’s lived under for 13 years, telling a Los Angeles probate judge that she wants her life back.

In a 24-minute statement, Ms. Spears told the judge overseeing the conservatorship that she wants it to end “without having to be evaluated.” She called the arrangement “abusive” and said she’s been “traumatized” and “in denial” despite the upbeat messages that she’s posted on Instagram during the past year, according to Reuters.

“I just want my life back,” she said. “I’m not here to be anyone’s slave.”

After the statement, the court recessed, and the audio transmission was stopped, Reuters reported. Full transcripts have been published by several news outlets, including this lightly edited version by Variety.

Ms. Spears’ statement came as a shock after years of silence about the conservatorship. Public speculation about the arrangement has resurfaced during the past year because of the #FreeBritney movement on social media, news reports of leaked court documents, and a 2021 documentary that showed she may feel trapped.

During the hearing, Ms. Spears spoke by phone to Los Angeles Superior Court Judge Brenda Penny about the court-approved arrangement that began in 2008 after she had a mental health breakdown. Judge Penny said Ms. Spears would need to submit a petition to the court to ask for the conservatorship to be terminated.

Under the terms of the conservatorship, Ms. Spears would have to demonstrate that she can take responsibility for her personal and financial affairs, Reuters reported. During the hearing, Judge Penny supported Ms. Spears for speaking out.

“I know it took a lot of courage for you to say everything you have to say today,” she said. “I want to let you know that the court does appreciate your coming on the line and sharing how you’re feeling.”

Ms. Spears, 39, said she wanted to get married again and have a baby but that she’s not allowed to go to the doctor to get a contraceptive device removed. She spoke up about her mental health and said doctors had put her on the drug lithium, which made her less able to function. Ms. Spears also said she was forced to perform in the past and is now required to attend numerous therapy sessions each week against her will.

“I’m not happy. I can’t sleep. I’m so angry, it’s insane,” she said. “And I’m depressed. I cry every day.”

Ms. Spears last spoke with the court in May 2019, but the hearing was closed to the public and her testimony was sealed. Ms. Spears recently said she wanted people to hear her thoughts.

“I feel ganged-up on and I feel bullied and I feel left out and alone,” she said. “I deserve to have the same rights as anybody does, by having a child, a family, any of those things, and more so.”

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

Pop icon Britney Spears spoke out recently against the conservatorship that she’s lived under for 13 years, telling a Los Angeles probate judge that she wants her life back.

In a 24-minute statement, Ms. Spears told the judge overseeing the conservatorship that she wants it to end “without having to be evaluated.” She called the arrangement “abusive” and said she’s been “traumatized” and “in denial” despite the upbeat messages that she’s posted on Instagram during the past year, according to Reuters.

“I just want my life back,” she said. “I’m not here to be anyone’s slave.”

After the statement, the court recessed, and the audio transmission was stopped, Reuters reported. Full transcripts have been published by several news outlets, including this lightly edited version by Variety.

Ms. Spears’ statement came as a shock after years of silence about the conservatorship. Public speculation about the arrangement has resurfaced during the past year because of the #FreeBritney movement on social media, news reports of leaked court documents, and a 2021 documentary that showed she may feel trapped.

During the hearing, Ms. Spears spoke by phone to Los Angeles Superior Court Judge Brenda Penny about the court-approved arrangement that began in 2008 after she had a mental health breakdown. Judge Penny said Ms. Spears would need to submit a petition to the court to ask for the conservatorship to be terminated.

Under the terms of the conservatorship, Ms. Spears would have to demonstrate that she can take responsibility for her personal and financial affairs, Reuters reported. During the hearing, Judge Penny supported Ms. Spears for speaking out.

“I know it took a lot of courage for you to say everything you have to say today,” she said. “I want to let you know that the court does appreciate your coming on the line and sharing how you’re feeling.”

Ms. Spears, 39, said she wanted to get married again and have a baby but that she’s not allowed to go to the doctor to get a contraceptive device removed. She spoke up about her mental health and said doctors had put her on the drug lithium, which made her less able to function. Ms. Spears also said she was forced to perform in the past and is now required to attend numerous therapy sessions each week against her will.

“I’m not happy. I can’t sleep. I’m so angry, it’s insane,” she said. “And I’m depressed. I cry every day.”

Ms. Spears last spoke with the court in May 2019, but the hearing was closed to the public and her testimony was sealed. Ms. Spears recently said she wanted people to hear her thoughts.

“I feel ganged-up on and I feel bullied and I feel left out and alone,” she said. “I deserve to have the same rights as anybody does, by having a child, a family, any of those things, and more so.”

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

Pop icon Britney Spears spoke out recently against the conservatorship that she’s lived under for 13 years, telling a Los Angeles probate judge that she wants her life back.

In a 24-minute statement, Ms. Spears told the judge overseeing the conservatorship that she wants it to end “without having to be evaluated.” She called the arrangement “abusive” and said she’s been “traumatized” and “in denial” despite the upbeat messages that she’s posted on Instagram during the past year, according to Reuters.

“I just want my life back,” she said. “I’m not here to be anyone’s slave.”

After the statement, the court recessed, and the audio transmission was stopped, Reuters reported. Full transcripts have been published by several news outlets, including this lightly edited version by Variety.

Ms. Spears’ statement came as a shock after years of silence about the conservatorship. Public speculation about the arrangement has resurfaced during the past year because of the #FreeBritney movement on social media, news reports of leaked court documents, and a 2021 documentary that showed she may feel trapped.

During the hearing, Ms. Spears spoke by phone to Los Angeles Superior Court Judge Brenda Penny about the court-approved arrangement that began in 2008 after she had a mental health breakdown. Judge Penny said Ms. Spears would need to submit a petition to the court to ask for the conservatorship to be terminated.

Under the terms of the conservatorship, Ms. Spears would have to demonstrate that she can take responsibility for her personal and financial affairs, Reuters reported. During the hearing, Judge Penny supported Ms. Spears for speaking out.

“I know it took a lot of courage for you to say everything you have to say today,” she said. “I want to let you know that the court does appreciate your coming on the line and sharing how you’re feeling.”

Ms. Spears, 39, said she wanted to get married again and have a baby but that she’s not allowed to go to the doctor to get a contraceptive device removed. She spoke up about her mental health and said doctors had put her on the drug lithium, which made her less able to function. Ms. Spears also said she was forced to perform in the past and is now required to attend numerous therapy sessions each week against her will.

“I’m not happy. I can’t sleep. I’m so angry, it’s insane,” she said. “And I’m depressed. I cry every day.”

Ms. Spears last spoke with the court in May 2019, but the hearing was closed to the public and her testimony was sealed. Ms. Spears recently said she wanted people to hear her thoughts.

“I feel ganged-up on and I feel bullied and I feel left out and alone,” she said. “I deserve to have the same rights as anybody does, by having a child, a family, any of those things, and more so.”

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

Young adults who use cannabis – either sporadically, daily, or those who have cannabis use disorder – have a significantly increased risk for suicidal thoughts and actions, according to U.S. national drug survey data.

The risks appear greater for women than men and remained regardless of whether the individual was depressed.

“We cannot establish that cannabis use caused increased suicidality,” Nora Volkow, MD, director, National Institute on Drug Abuse (NIDA), told this news organization.

“However, it is likely that these two factors influence one another bidirectionally, meaning people with suicidal thinking might be more vulnerable to cannabis use to self-medicate their distress, and cannabis use may trigger negative moods and suicidal thinking in some people,” said Dr. Volkow.

“It is also possible that these factors are not causally linked to one another at all but rather reflect the common and related risk factors underlying both suicidality and substance use. For instance, one’s genetics may put them at a higher risk for both suicide and for using marijuana,” she added.

The study was published online June 22 in JAMA Network Open.
 

Marked increase in use

Cannabis use among U.S. adults has increased markedly over the past 10 years, with a parallel increase in suicidality. However, the links between cannabis use and suicidality among young adults are poorly understood.

NIDA researchers sought to fill this gap. They examined data on 281,650 young men and women aged 18 to 34 years who participated in National Surveys on Drug Use and Health from 2008 to 2019.

Status regarding past-year cannabis use was categorized as past-year daily or near-daily use (greater than or equal to 300 days), non-daily use, and no cannabis use.

Although suicidality was associated with cannabis use, even young adults who did not use cannabis on a daily basis were more likely to have suicidal thoughts or actions than those who did not use the drug at all, the researchers found.

Among young adults without a major depressive episode, about 3% of those who did not use cannabis had suicidal ideation, compared with about 7% of non-daily cannabis users, about 9% of daily cannabis users, and 14% of those with a cannabis use disorder.

Among young adults with depression, the corresponding percentages were 35%, 44%, 53%, and 50%.

Similar trends existed for the associations between the different levels of cannabis use and suicide plan or attempt.
 

Women at greatest risk

Gender differences also emerged. Women who used cannabis at any level were more likely to have suicidal ideation or report a suicide plan or attempt than men with the same levels of cannabis use.

Among those without a major depressive episode, the prevalence of suicidal ideation for those with versus without a cannabis use disorder was around 14% versus 4.0% among women and 10% versus 3.0% among men.

Among young adults with both cannabis use disorder and major depressive episode, the prevalence of past-year suicide plan was 52% higher for women (24%) than for men (16%).

“Suicide is a leading cause of death among young adults in the United States, and the findings of this study offer important information that may help us reduce this risk,” lead author and NIDA researcher Beth Han, MD, PhD, MPH, said in a news release.

“Depression and cannabis use disorder are treatable conditions, and cannabis use can be modified. Through better understanding the associations of different risk factors for suicidality, we hope to offer new targets for prevention and intervention in individuals that we know may be at high risk. These findings also underscore the importance of tailoring interventions in a way that takes sex and gender into account,” said Dr. Han.

“Additional research is needed to better understand these complex associations, especially given the great burden of suicide on young adults,” said Dr. Volkow.
 

Gender difference ‘striking’

Commenting on the findings for this news organization, Charles B. Nemeroff, MD, PhD, professor and chair, department of psychiatry and behavioral sciences, Dell Medical School, University of Texas at Austin, said this study is “clearly of great interest; of course correlation and causality are completely distinct entities, and this study is all about correlation.

“This does not, of course, mean that cannabis use causes suicide but suggests that in individuals who use cannabis, suicidality in the broadest sense is increased in prevalence rate,” said Dr. Nemeroff, who serves as principal investigator of the Texas Child Trauma Network.

Dr. Nemeroff said “the most striking finding” was the larger effect in women than men – “striking because suicide is, in almost all cultures, higher in prevalence in men versus women.”

Dr. Nemeroff said he’d like to know more about other potential contributing factors, “which would include a history of child abuse and neglect, a major vulnerability factor for suicidality, comorbid alcohol and other substance abuse, [and] comorbid psychiatric diagnosis such as posttraumatic stress disorder.”

The study was sponsored by NIDA, of the National Institutes of Health. Dr. Volkow, Dr. Han, and Dr. Nemeroff have disclosed no relevant financial relationships.

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

Young adults who use cannabis – either sporadically, daily, or those who have cannabis use disorder – have a significantly increased risk for suicidal thoughts and actions, according to U.S. national drug survey data.

The risks appear greater for women than men and remained regardless of whether the individual was depressed.

“We cannot establish that cannabis use caused increased suicidality,” Nora Volkow, MD, director, National Institute on Drug Abuse (NIDA), told this news organization.

“However, it is likely that these two factors influence one another bidirectionally, meaning people with suicidal thinking might be more vulnerable to cannabis use to self-medicate their distress, and cannabis use may trigger negative moods and suicidal thinking in some people,” said Dr. Volkow.

“It is also possible that these factors are not causally linked to one another at all but rather reflect the common and related risk factors underlying both suicidality and substance use. For instance, one’s genetics may put them at a higher risk for both suicide and for using marijuana,” she added.

The study was published online June 22 in JAMA Network Open.
 

Marked increase in use

Cannabis use among U.S. adults has increased markedly over the past 10 years, with a parallel increase in suicidality. However, the links between cannabis use and suicidality among young adults are poorly understood.

NIDA researchers sought to fill this gap. They examined data on 281,650 young men and women aged 18 to 34 years who participated in National Surveys on Drug Use and Health from 2008 to 2019.

Status regarding past-year cannabis use was categorized as past-year daily or near-daily use (greater than or equal to 300 days), non-daily use, and no cannabis use.

Although suicidality was associated with cannabis use, even young adults who did not use cannabis on a daily basis were more likely to have suicidal thoughts or actions than those who did not use the drug at all, the researchers found.

Among young adults without a major depressive episode, about 3% of those who did not use cannabis had suicidal ideation, compared with about 7% of non-daily cannabis users, about 9% of daily cannabis users, and 14% of those with a cannabis use disorder.

Among young adults with depression, the corresponding percentages were 35%, 44%, 53%, and 50%.

Similar trends existed for the associations between the different levels of cannabis use and suicide plan or attempt.
 

Women at greatest risk

Gender differences also emerged. Women who used cannabis at any level were more likely to have suicidal ideation or report a suicide plan or attempt than men with the same levels of cannabis use.

Among those without a major depressive episode, the prevalence of suicidal ideation for those with versus without a cannabis use disorder was around 14% versus 4.0% among women and 10% versus 3.0% among men.

Among young adults with both cannabis use disorder and major depressive episode, the prevalence of past-year suicide plan was 52% higher for women (24%) than for men (16%).

“Suicide is a leading cause of death among young adults in the United States, and the findings of this study offer important information that may help us reduce this risk,” lead author and NIDA researcher Beth Han, MD, PhD, MPH, said in a news release.

“Depression and cannabis use disorder are treatable conditions, and cannabis use can be modified. Through better understanding the associations of different risk factors for suicidality, we hope to offer new targets for prevention and intervention in individuals that we know may be at high risk. These findings also underscore the importance of tailoring interventions in a way that takes sex and gender into account,” said Dr. Han.

“Additional research is needed to better understand these complex associations, especially given the great burden of suicide on young adults,” said Dr. Volkow.
 

Gender difference ‘striking’

Commenting on the findings for this news organization, Charles B. Nemeroff, MD, PhD, professor and chair, department of psychiatry and behavioral sciences, Dell Medical School, University of Texas at Austin, said this study is “clearly of great interest; of course correlation and causality are completely distinct entities, and this study is all about correlation.

“This does not, of course, mean that cannabis use causes suicide but suggests that in individuals who use cannabis, suicidality in the broadest sense is increased in prevalence rate,” said Dr. Nemeroff, who serves as principal investigator of the Texas Child Trauma Network.

Dr. Nemeroff said “the most striking finding” was the larger effect in women than men – “striking because suicide is, in almost all cultures, higher in prevalence in men versus women.”

Dr. Nemeroff said he’d like to know more about other potential contributing factors, “which would include a history of child abuse and neglect, a major vulnerability factor for suicidality, comorbid alcohol and other substance abuse, [and] comorbid psychiatric diagnosis such as posttraumatic stress disorder.”

The study was sponsored by NIDA, of the National Institutes of Health. Dr. Volkow, Dr. Han, and Dr. Nemeroff have disclosed no relevant financial relationships.

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

Young adults who use cannabis – either sporadically, daily, or those who have cannabis use disorder – have a significantly increased risk for suicidal thoughts and actions, according to U.S. national drug survey data.

The risks appear greater for women than men and remained regardless of whether the individual was depressed.

“We cannot establish that cannabis use caused increased suicidality,” Nora Volkow, MD, director, National Institute on Drug Abuse (NIDA), told this news organization.

“However, it is likely that these two factors influence one another bidirectionally, meaning people with suicidal thinking might be more vulnerable to cannabis use to self-medicate their distress, and cannabis use may trigger negative moods and suicidal thinking in some people,” said Dr. Volkow.

“It is also possible that these factors are not causally linked to one another at all but rather reflect the common and related risk factors underlying both suicidality and substance use. For instance, one’s genetics may put them at a higher risk for both suicide and for using marijuana,” she added.

The study was published online June 22 in JAMA Network Open.
 

Marked increase in use

Cannabis use among U.S. adults has increased markedly over the past 10 years, with a parallel increase in suicidality. However, the links between cannabis use and suicidality among young adults are poorly understood.

NIDA researchers sought to fill this gap. They examined data on 281,650 young men and women aged 18 to 34 years who participated in National Surveys on Drug Use and Health from 2008 to 2019.

Status regarding past-year cannabis use was categorized as past-year daily or near-daily use (greater than or equal to 300 days), non-daily use, and no cannabis use.

Although suicidality was associated with cannabis use, even young adults who did not use cannabis on a daily basis were more likely to have suicidal thoughts or actions than those who did not use the drug at all, the researchers found.

Among young adults without a major depressive episode, about 3% of those who did not use cannabis had suicidal ideation, compared with about 7% of non-daily cannabis users, about 9% of daily cannabis users, and 14% of those with a cannabis use disorder.

Among young adults with depression, the corresponding percentages were 35%, 44%, 53%, and 50%.

Similar trends existed for the associations between the different levels of cannabis use and suicide plan or attempt.
 

Women at greatest risk

Gender differences also emerged. Women who used cannabis at any level were more likely to have suicidal ideation or report a suicide plan or attempt than men with the same levels of cannabis use.

Among those without a major depressive episode, the prevalence of suicidal ideation for those with versus without a cannabis use disorder was around 14% versus 4.0% among women and 10% versus 3.0% among men.

Among young adults with both cannabis use disorder and major depressive episode, the prevalence of past-year suicide plan was 52% higher for women (24%) than for men (16%).

“Suicide is a leading cause of death among young adults in the United States, and the findings of this study offer important information that may help us reduce this risk,” lead author and NIDA researcher Beth Han, MD, PhD, MPH, said in a news release.

“Depression and cannabis use disorder are treatable conditions, and cannabis use can be modified. Through better understanding the associations of different risk factors for suicidality, we hope to offer new targets for prevention and intervention in individuals that we know may be at high risk. These findings also underscore the importance of tailoring interventions in a way that takes sex and gender into account,” said Dr. Han.

“Additional research is needed to better understand these complex associations, especially given the great burden of suicide on young adults,” said Dr. Volkow.
 

Gender difference ‘striking’

Commenting on the findings for this news organization, Charles B. Nemeroff, MD, PhD, professor and chair, department of psychiatry and behavioral sciences, Dell Medical School, University of Texas at Austin, said this study is “clearly of great interest; of course correlation and causality are completely distinct entities, and this study is all about correlation.

“This does not, of course, mean that cannabis use causes suicide but suggests that in individuals who use cannabis, suicidality in the broadest sense is increased in prevalence rate,” said Dr. Nemeroff, who serves as principal investigator of the Texas Child Trauma Network.

Dr. Nemeroff said “the most striking finding” was the larger effect in women than men – “striking because suicide is, in almost all cultures, higher in prevalence in men versus women.”

Dr. Nemeroff said he’d like to know more about other potential contributing factors, “which would include a history of child abuse and neglect, a major vulnerability factor for suicidality, comorbid alcohol and other substance abuse, [and] comorbid psychiatric diagnosis such as posttraumatic stress disorder.”

The study was sponsored by NIDA, of the National Institutes of Health. Dr. Volkow, Dr. Han, and Dr. Nemeroff have disclosed no relevant financial relationships.

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

A single, simple question about sleep habits asked to people with diabetes in the UK Biobank database identified a subgroup with a nearly doubled mortality rate during almost 9 years of follow-up: those who said they usually had sleep disturbances.

The question was: Do you never, rarely, sometimes, or usually have trouble falling asleep, or waking in the middle of the night?

Adults in the UK Biobank with any form of self-reported diabetes or insulin use who answered that they usually have sleep disturbances had a significant 87% higher mortality rate than did those without diabetes who said they never or rarely had sleep disturbances, in a fully adjusted model with an average follow-up of 8.9 years, Kristen L. Knutson, PhD, and coauthors reported in the Journal of Sleep Research.

Mortality was 11% higher in respondents who reported frequent sleep disturbances but had no diabetes than in those without frequent sleep disturbances. Furthermore, those with diabetes but without frequent sleep disturbances had a 67% higher mortality rate, compared with those without diabetes. Both differences were statistically significant in a model that adjusted for age, sex, ethnicity, smoking, sleep duration, body mass index, and other covariates.

The findings suggest that diabetes and frequent sleep disturbances act in a roughly additive way to raise mortality risk, said Dr. Knutson, an epidemiologist and neurologist who specializes in sleep medicine at Northwestern University, Chicago.

She suggested that, based on these findings, clinicians should consider annually asking patients with diabetes this key question about the frequency of their sleep disturbances. They should then follow up with patients who report usual disturbances by referring them to a sleep clinic to test for a sleep disorders such as insomnia or sleep apnea. Sleep apnea especially is “particularly common in patients with type 2 diabetes,” Dr. Knutson noted in an interview.
 

A need to ‘spread awareness’ about diabetes and disturbed sleep.

The study run by Dr. Knutson and associates “is one of the largest population-based studies” to examine the relationship between sleep disturbances, diabetes, and mortality, commented Sirimon Reutrakul, MD, an endocrinologist and diabetes specialist at the University of Illinois Hospital in Chicago.

“This study highlights the detrimental effects of sleep disturbances in people with or without diabetes, and adds to the effects of sleep disturbances such as insomnia symptoms. People with diabetes often have sleep disturbances. Obstructive sleep apnea is very common in people with diabetes, and insomnia symptoms could be present in people with obstructive sleep apnea or it could be a separate problem,” Dr. Reutrakul said in an interview. Sleep disturbances can arise from direct effects of diabetes, such as nocturia, worry about glucose levels, pain, depressive symptoms, and anxiety, or can result from comorbidities that interfere with sleep.

“It is prudent to ask patients with diabetes about sleep patterns,” said Dr. Reutrakul, and she endorsed the specific question that Dr. Knutson recommended asking patients. Other aspects of sleep quality that could be helpful for a diagnosis include sleep duration, sleep timing, and snoring. “Some physicians ask these questions, but we need to spread awareness,” she added.

Prior to referring patients to a sleep clinic, Dr. Reutrakul suggested that clinicians could also assess possible triggers such as inadequate glucose control, pain, and anxiety, and they could also recommend good sleep hygiene strategies such as what’s recommended by the Sleep Foundation.
 

Sleep disturbances ‘highly prevalent’ among U.K. adults.

The UK Biobank enrolled just over 500,000 people aged 37-73 years during 2006-2010, and 487,728 of these people had data available that allowed their inclusion in the analysis. That group averaged about 57 years of age, 54% were women, 94% were White, and their average body mass index was 27-28 kg/m2.

More than a quarter of these people reported having “usual” sleep disturbances, showing that sleep disturbances are “highly prevalent” among U.K. residents, noted the authors. Just under a quarter of the subjects reported they never or rarely had sleep disturbances, and the remaining half of subjects said they “sometimes” had sleep disturbances.

In addition, 69% reported neither diabetes nor frequent sleep disturbances, 26% had frequent sleep disturbances but no diabetes, 3% had diabetes but not frequent sleep disturbances, and 2% had both diabetes and frequent sleep disturbances.

During the average 8.9-year follow-up, 19,177 people died from any cause (4%), and 3,874 of these deaths involved cardiovascular disease causes. Despite the significant association of diabetes and frequent sleep disturbances with an increased rate of all-cause mortality, the same combination showed no significant link with cardiovascular mortality in the study’s full-adjusted model. This may be because “frequent sleep disturbances can lead to a variety of causes of death,” Dr. Knutson suggested.

The information collected by the UK Biobank did not allow the researchers to distinguish between type 1 and type 2 diabetes.

The findings “suggest that regardless of the cause of sleep disturbance, reporting sleep disturbances on a frequent basis is an important signal of elevated risk of mortality. Such symptoms should therefore be investigated further by physicians, particularly in patients who have also been diagnosed with diabetes,” wrote Dr. Knutson and coauthors. “This is the first study to examine the effect of the combination of insomnia and diabetes on mortality risk.”

But Dr. Knutson highlighted that “sleep problems are important for everyone, not just people with diabetes.

Neither Dr. Knutson and coauthors nor Dr. Reutrakul had no disclosures.

[email protected]

A single, simple question about sleep habits asked to people with diabetes in the UK Biobank database identified a subgroup with a nearly doubled mortality rate during almost 9 years of follow-up: those who said they usually had sleep disturbances.

The question was: Do you never, rarely, sometimes, or usually have trouble falling asleep, or waking in the middle of the night?

Adults in the UK Biobank with any form of self-reported diabetes or insulin use who answered that they usually have sleep disturbances had a significant 87% higher mortality rate than did those without diabetes who said they never or rarely had sleep disturbances, in a fully adjusted model with an average follow-up of 8.9 years, Kristen L. Knutson, PhD, and coauthors reported in the Journal of Sleep Research.

Mortality was 11% higher in respondents who reported frequent sleep disturbances but had no diabetes than in those without frequent sleep disturbances. Furthermore, those with diabetes but without frequent sleep disturbances had a 67% higher mortality rate, compared with those without diabetes. Both differences were statistically significant in a model that adjusted for age, sex, ethnicity, smoking, sleep duration, body mass index, and other covariates.

The findings suggest that diabetes and frequent sleep disturbances act in a roughly additive way to raise mortality risk, said Dr. Knutson, an epidemiologist and neurologist who specializes in sleep medicine at Northwestern University, Chicago.

She suggested that, based on these findings, clinicians should consider annually asking patients with diabetes this key question about the frequency of their sleep disturbances. They should then follow up with patients who report usual disturbances by referring them to a sleep clinic to test for a sleep disorders such as insomnia or sleep apnea. Sleep apnea especially is “particularly common in patients with type 2 diabetes,” Dr. Knutson noted in an interview.
 

A need to ‘spread awareness’ about diabetes and disturbed sleep.

The study run by Dr. Knutson and associates “is one of the largest population-based studies” to examine the relationship between sleep disturbances, diabetes, and mortality, commented Sirimon Reutrakul, MD, an endocrinologist and diabetes specialist at the University of Illinois Hospital in Chicago.

“This study highlights the detrimental effects of sleep disturbances in people with or without diabetes, and adds to the effects of sleep disturbances such as insomnia symptoms. People with diabetes often have sleep disturbances. Obstructive sleep apnea is very common in people with diabetes, and insomnia symptoms could be present in people with obstructive sleep apnea or it could be a separate problem,” Dr. Reutrakul said in an interview. Sleep disturbances can arise from direct effects of diabetes, such as nocturia, worry about glucose levels, pain, depressive symptoms, and anxiety, or can result from comorbidities that interfere with sleep.

“It is prudent to ask patients with diabetes about sleep patterns,” said Dr. Reutrakul, and she endorsed the specific question that Dr. Knutson recommended asking patients. Other aspects of sleep quality that could be helpful for a diagnosis include sleep duration, sleep timing, and snoring. “Some physicians ask these questions, but we need to spread awareness,” she added.

Prior to referring patients to a sleep clinic, Dr. Reutrakul suggested that clinicians could also assess possible triggers such as inadequate glucose control, pain, and anxiety, and they could also recommend good sleep hygiene strategies such as what’s recommended by the Sleep Foundation.
 

Sleep disturbances ‘highly prevalent’ among U.K. adults.

The UK Biobank enrolled just over 500,000 people aged 37-73 years during 2006-2010, and 487,728 of these people had data available that allowed their inclusion in the analysis. That group averaged about 57 years of age, 54% were women, 94% were White, and their average body mass index was 27-28 kg/m2.

More than a quarter of these people reported having “usual” sleep disturbances, showing that sleep disturbances are “highly prevalent” among U.K. residents, noted the authors. Just under a quarter of the subjects reported they never or rarely had sleep disturbances, and the remaining half of subjects said they “sometimes” had sleep disturbances.

In addition, 69% reported neither diabetes nor frequent sleep disturbances, 26% had frequent sleep disturbances but no diabetes, 3% had diabetes but not frequent sleep disturbances, and 2% had both diabetes and frequent sleep disturbances.

During the average 8.9-year follow-up, 19,177 people died from any cause (4%), and 3,874 of these deaths involved cardiovascular disease causes. Despite the significant association of diabetes and frequent sleep disturbances with an increased rate of all-cause mortality, the same combination showed no significant link with cardiovascular mortality in the study’s full-adjusted model. This may be because “frequent sleep disturbances can lead to a variety of causes of death,” Dr. Knutson suggested.

The information collected by the UK Biobank did not allow the researchers to distinguish between type 1 and type 2 diabetes.

The findings “suggest that regardless of the cause of sleep disturbance, reporting sleep disturbances on a frequent basis is an important signal of elevated risk of mortality. Such symptoms should therefore be investigated further by physicians, particularly in patients who have also been diagnosed with diabetes,” wrote Dr. Knutson and coauthors. “This is the first study to examine the effect of the combination of insomnia and diabetes on mortality risk.”

But Dr. Knutson highlighted that “sleep problems are important for everyone, not just people with diabetes.

Neither Dr. Knutson and coauthors nor Dr. Reutrakul had no disclosures.

[email protected]

A single, simple question about sleep habits asked to people with diabetes in the UK Biobank database identified a subgroup with a nearly doubled mortality rate during almost 9 years of follow-up: those who said they usually had sleep disturbances.

The question was: Do you never, rarely, sometimes, or usually have trouble falling asleep, or waking in the middle of the night?

Adults in the UK Biobank with any form of self-reported diabetes or insulin use who answered that they usually have sleep disturbances had a significant 87% higher mortality rate than did those without diabetes who said they never or rarely had sleep disturbances, in a fully adjusted model with an average follow-up of 8.9 years, Kristen L. Knutson, PhD, and coauthors reported in the Journal of Sleep Research.

Mortality was 11% higher in respondents who reported frequent sleep disturbances but had no diabetes than in those without frequent sleep disturbances. Furthermore, those with diabetes but without frequent sleep disturbances had a 67% higher mortality rate, compared with those without diabetes. Both differences were statistically significant in a model that adjusted for age, sex, ethnicity, smoking, sleep duration, body mass index, and other covariates.

The findings suggest that diabetes and frequent sleep disturbances act in a roughly additive way to raise mortality risk, said Dr. Knutson, an epidemiologist and neurologist who specializes in sleep medicine at Northwestern University, Chicago.

She suggested that, based on these findings, clinicians should consider annually asking patients with diabetes this key question about the frequency of their sleep disturbances. They should then follow up with patients who report usual disturbances by referring them to a sleep clinic to test for a sleep disorders such as insomnia or sleep apnea. Sleep apnea especially is “particularly common in patients with type 2 diabetes,” Dr. Knutson noted in an interview.
 

A need to ‘spread awareness’ about diabetes and disturbed sleep.

The study run by Dr. Knutson and associates “is one of the largest population-based studies” to examine the relationship between sleep disturbances, diabetes, and mortality, commented Sirimon Reutrakul, MD, an endocrinologist and diabetes specialist at the University of Illinois Hospital in Chicago.

“This study highlights the detrimental effects of sleep disturbances in people with or without diabetes, and adds to the effects of sleep disturbances such as insomnia symptoms. People with diabetes often have sleep disturbances. Obstructive sleep apnea is very common in people with diabetes, and insomnia symptoms could be present in people with obstructive sleep apnea or it could be a separate problem,” Dr. Reutrakul said in an interview. Sleep disturbances can arise from direct effects of diabetes, such as nocturia, worry about glucose levels, pain, depressive symptoms, and anxiety, or can result from comorbidities that interfere with sleep.

“It is prudent to ask patients with diabetes about sleep patterns,” said Dr. Reutrakul, and she endorsed the specific question that Dr. Knutson recommended asking patients. Other aspects of sleep quality that could be helpful for a diagnosis include sleep duration, sleep timing, and snoring. “Some physicians ask these questions, but we need to spread awareness,” she added.

Prior to referring patients to a sleep clinic, Dr. Reutrakul suggested that clinicians could also assess possible triggers such as inadequate glucose control, pain, and anxiety, and they could also recommend good sleep hygiene strategies such as what’s recommended by the Sleep Foundation.
 

Sleep disturbances ‘highly prevalent’ among U.K. adults.

The UK Biobank enrolled just over 500,000 people aged 37-73 years during 2006-2010, and 487,728 of these people had data available that allowed their inclusion in the analysis. That group averaged about 57 years of age, 54% were women, 94% were White, and their average body mass index was 27-28 kg/m2.

More than a quarter of these people reported having “usual” sleep disturbances, showing that sleep disturbances are “highly prevalent” among U.K. residents, noted the authors. Just under a quarter of the subjects reported they never or rarely had sleep disturbances, and the remaining half of subjects said they “sometimes” had sleep disturbances.

In addition, 69% reported neither diabetes nor frequent sleep disturbances, 26% had frequent sleep disturbances but no diabetes, 3% had diabetes but not frequent sleep disturbances, and 2% had both diabetes and frequent sleep disturbances.

During the average 8.9-year follow-up, 19,177 people died from any cause (4%), and 3,874 of these deaths involved cardiovascular disease causes. Despite the significant association of diabetes and frequent sleep disturbances with an increased rate of all-cause mortality, the same combination showed no significant link with cardiovascular mortality in the study’s full-adjusted model. This may be because “frequent sleep disturbances can lead to a variety of causes of death,” Dr. Knutson suggested.

The information collected by the UK Biobank did not allow the researchers to distinguish between type 1 and type 2 diabetes.

The findings “suggest that regardless of the cause of sleep disturbance, reporting sleep disturbances on a frequent basis is an important signal of elevated risk of mortality. Such symptoms should therefore be investigated further by physicians, particularly in patients who have also been diagnosed with diabetes,” wrote Dr. Knutson and coauthors. “This is the first study to examine the effect of the combination of insomnia and diabetes on mortality risk.”

But Dr. Knutson highlighted that “sleep problems are important for everyone, not just people with diabetes.

Neither Dr. Knutson and coauthors nor Dr. Reutrakul had no disclosures.

[email protected]

Pfizer is suspending distribution of the antismoking treatment Chantix after heightened levels of the carcinogen N-nitrosodimethylamine (NDMA) were found in some lots of the pills.

The pharmaceutical company is also recalling some lots of Chantix that may have high levels of NDMA, Reuters reported.

Pfizer told Reuters the distribution pause was ordered out of abundance of caution while further testing is conducted. The FDA approved varenicline, which is marketed as Chantix, in 2006.

“The benefits of Chantix outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime,” Pfizer spokesperson Steven Danehy said in an email, according to Reuters.

The FDA has not issued a recall on Chantix. In Canada, however, health authorities on June 8 instituted a recall for Champix, the name under which the drug is sold in that nation.

The Chantix website says it’s a 3- to 6-month treatment that helps people overcome the need to smoke tobacco. The website says more than 13 million people have been prescribed Chantix.

Other health concerns have been raised about Chantix, such as mental health side effects.

In 2016, however, researchers concluded Chantix did not appear to raise the risk of serious health disorders such as depression, anxiety, and suicidal thoughts.

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

Pfizer is suspending distribution of the antismoking treatment Chantix after heightened levels of the carcinogen N-nitrosodimethylamine (NDMA) were found in some lots of the pills.

The pharmaceutical company is also recalling some lots of Chantix that may have high levels of NDMA, Reuters reported.

Pfizer told Reuters the distribution pause was ordered out of abundance of caution while further testing is conducted. The FDA approved varenicline, which is marketed as Chantix, in 2006.

“The benefits of Chantix outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime,” Pfizer spokesperson Steven Danehy said in an email, according to Reuters.

The FDA has not issued a recall on Chantix. In Canada, however, health authorities on June 8 instituted a recall for Champix, the name under which the drug is sold in that nation.

The Chantix website says it’s a 3- to 6-month treatment that helps people overcome the need to smoke tobacco. The website says more than 13 million people have been prescribed Chantix.

Other health concerns have been raised about Chantix, such as mental health side effects.

In 2016, however, researchers concluded Chantix did not appear to raise the risk of serious health disorders such as depression, anxiety, and suicidal thoughts.

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

Pfizer is suspending distribution of the antismoking treatment Chantix after heightened levels of the carcinogen N-nitrosodimethylamine (NDMA) were found in some lots of the pills.

The pharmaceutical company is also recalling some lots of Chantix that may have high levels of NDMA, Reuters reported.

Pfizer told Reuters the distribution pause was ordered out of abundance of caution while further testing is conducted. The FDA approved varenicline, which is marketed as Chantix, in 2006.

“The benefits of Chantix outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime,” Pfizer spokesperson Steven Danehy said in an email, according to Reuters.

The FDA has not issued a recall on Chantix. In Canada, however, health authorities on June 8 instituted a recall for Champix, the name under which the drug is sold in that nation.

The Chantix website says it’s a 3- to 6-month treatment that helps people overcome the need to smoke tobacco. The website says more than 13 million people have been prescribed Chantix.

Other health concerns have been raised about Chantix, such as mental health side effects.

In 2016, however, researchers concluded Chantix did not appear to raise the risk of serious health disorders such as depression, anxiety, and suicidal thoughts.

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

The U.S. Food and Drug Administration has granted breakthrough therapy designation for lecanemab (Eisai/Biogen), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of Alzheimer’s disease.

Lecanemab (formerly BAN2401) is a humanized monoclonal antibody that selectively binds to large, soluble aggregated Abeta protofibrils. The antibody was developed following the discovery of a mutation in amyloid precursor protein that leads to a form of Alzheimer’s disease that is marked by particularly high levels of Abeta protofibrils.

“As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease,” Eisai and Biogen said in a joint news release.

The breakthrough therapy designation for lecanemab is based on results of a randomized, double-blind, phase 2b proof-of-concept study published April 17 in Alzheimer’s Research & Therapy.

The study enrolled 856 patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease with confirmed presence of amyloid pathology.

At the highest doses, treatment with lecanemab led to a reduction in brain amyloid accompanied by a consistent reduction of clinical decline across several clinical and biomarker endpoints.
 

Phase 3 testing underway

In March, Eisai and Biogen completed enrollment in a phase 3 study designed to confirm the safety and efficacy of lecanemab in patients with symptomatic early Alzheimer’s disease. 

The CLARITY AD study includes 1,795 patients with early Alzheimer’s disease, and initial results are expected by the end of September 2022. The core study will compare lecanemab against placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months. The study will also evaluate the long-term safety and tolerability of lecanemab in the extension phase and whether the long-term effects of lecanemab, as measured by the CDR-SB at the end of the core study, are maintained over time.

Additionally, the phase 3 AHEAD 3-45 clinical study is currently exploring lecanemab in adults with preclinical Alzheimer’s disease (clinically normal but with intermediate or elevated brain amyloid).

On June 7, the FDA – amid significant controversy – approved aducanumab (Aduhelm), the first anti-amyloid agent for the treatment Alzheimer’s disease, disregarding the recommendation by its own advisory panel not to approve the drug. Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee subsequently resigned in protest following the agency’s approval of aducanumab.

In addition, the high-profile consumer advocacy group Public Citizen sent a letter to the secretary of the U.S. Department of Health & Human Services demanding the removal of three FDA officials, including acting FDA Commissioner Janet Woodcock, MD. 

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

The U.S. Food and Drug Administration has granted breakthrough therapy designation for lecanemab (Eisai/Biogen), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of Alzheimer’s disease.

Lecanemab (formerly BAN2401) is a humanized monoclonal antibody that selectively binds to large, soluble aggregated Abeta protofibrils. The antibody was developed following the discovery of a mutation in amyloid precursor protein that leads to a form of Alzheimer’s disease that is marked by particularly high levels of Abeta protofibrils.

“As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease,” Eisai and Biogen said in a joint news release.

The breakthrough therapy designation for lecanemab is based on results of a randomized, double-blind, phase 2b proof-of-concept study published April 17 in Alzheimer’s Research & Therapy.

The study enrolled 856 patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease with confirmed presence of amyloid pathology.

At the highest doses, treatment with lecanemab led to a reduction in brain amyloid accompanied by a consistent reduction of clinical decline across several clinical and biomarker endpoints.
 

Phase 3 testing underway

In March, Eisai and Biogen completed enrollment in a phase 3 study designed to confirm the safety and efficacy of lecanemab in patients with symptomatic early Alzheimer’s disease. 

The CLARITY AD study includes 1,795 patients with early Alzheimer’s disease, and initial results are expected by the end of September 2022. The core study will compare lecanemab against placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months. The study will also evaluate the long-term safety and tolerability of lecanemab in the extension phase and whether the long-term effects of lecanemab, as measured by the CDR-SB at the end of the core study, are maintained over time.

Additionally, the phase 3 AHEAD 3-45 clinical study is currently exploring lecanemab in adults with preclinical Alzheimer’s disease (clinically normal but with intermediate or elevated brain amyloid).

On June 7, the FDA – amid significant controversy – approved aducanumab (Aduhelm), the first anti-amyloid agent for the treatment Alzheimer’s disease, disregarding the recommendation by its own advisory panel not to approve the drug. Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee subsequently resigned in protest following the agency’s approval of aducanumab.

In addition, the high-profile consumer advocacy group Public Citizen sent a letter to the secretary of the U.S. Department of Health & Human Services demanding the removal of three FDA officials, including acting FDA Commissioner Janet Woodcock, MD. 

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

The U.S. Food and Drug Administration has granted breakthrough therapy designation for lecanemab (Eisai/Biogen), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of Alzheimer’s disease.

Lecanemab (formerly BAN2401) is a humanized monoclonal antibody that selectively binds to large, soluble aggregated Abeta protofibrils. The antibody was developed following the discovery of a mutation in amyloid precursor protein that leads to a form of Alzheimer’s disease that is marked by particularly high levels of Abeta protofibrils.

“As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease,” Eisai and Biogen said in a joint news release.

The breakthrough therapy designation for lecanemab is based on results of a randomized, double-blind, phase 2b proof-of-concept study published April 17 in Alzheimer’s Research & Therapy.

The study enrolled 856 patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease with confirmed presence of amyloid pathology.

At the highest doses, treatment with lecanemab led to a reduction in brain amyloid accompanied by a consistent reduction of clinical decline across several clinical and biomarker endpoints.
 

Phase 3 testing underway

In March, Eisai and Biogen completed enrollment in a phase 3 study designed to confirm the safety and efficacy of lecanemab in patients with symptomatic early Alzheimer’s disease. 

The CLARITY AD study includes 1,795 patients with early Alzheimer’s disease, and initial results are expected by the end of September 2022. The core study will compare lecanemab against placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months. The study will also evaluate the long-term safety and tolerability of lecanemab in the extension phase and whether the long-term effects of lecanemab, as measured by the CDR-SB at the end of the core study, are maintained over time.

Additionally, the phase 3 AHEAD 3-45 clinical study is currently exploring lecanemab in adults with preclinical Alzheimer’s disease (clinically normal but with intermediate or elevated brain amyloid).

On June 7, the FDA – amid significant controversy – approved aducanumab (Aduhelm), the first anti-amyloid agent for the treatment Alzheimer’s disease, disregarding the recommendation by its own advisory panel not to approve the drug. Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee subsequently resigned in protest following the agency’s approval of aducanumab.

In addition, the high-profile consumer advocacy group Public Citizen sent a letter to the secretary of the U.S. Department of Health & Human Services demanding the removal of three FDA officials, including acting FDA Commissioner Janet Woodcock, MD. 

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

More evidence suggests the severity of internet addiction (IA) is directly related to the severity of sleep problems in youth.

Results from a study of more than 4,000 adolescent students show IA severity was linked to less sleep and to daytime sleepiness. In addition, boys aged 12-14 years who were addicted to computer games versus social media networking were the most affected.

Sleep issues could be “easily detectable manifestations of pathological internet addiction,” investigator Sergey Tereshchenko, PhD, Scientific Research Institute for Medical Problems of the North, Krasnoyask State Medical University, Russia, told this news organization.

These sleep problems require attention and correction, Dr. Tereshchenko added.

The findings were presented at the virtual Congress of the European Academy of Neurology 2021.
 

New phenomenon

IA is a relatively new psychological phenomenon and is most prevalent in “socially vulnerable groups,” such as adolescents, Dr. Tereshchenko said.

He cited numerous studies that have “convincingly demonstrated” IA is comorbid with a broad range of psychopathologic conditions, including depression, anxiety, and attention deficit hyperactivity disorder.

There is also growing evidence, including from systematic reviews in 2014 and 2019, that IA affects a wide range of sleep parameters.

However, most studies in adolescents have used only one psychometric tool to assess addiction, revealing only the “general IA pattern” and not the type of IA, Dr. Tereshchenko noted.

Adolescents may not be addicted to the internet itself but to certain behaviors like gaming or social networking, he said.

The “undoubted advantage” of his team’s research is the use of more than one tool, making it possible to “verify the predominant content of the addiction,” he added.

The investigators previously assessed general prevalence of IA in adolescents in Siberia and found about 6.8% of participants displayed pathological IA behavior – and that gaming addiction is more common in boys whereas addiction to social networking is more common in girls.

This prevalence rate is lower than in the Philippines (21.1%), Hong Kong (16.4%), Malaysia (14.1%), China (11%), and South Korea (9.7%), but slightly higher than in Japan (6.2%).

IA prevalence among adolescents in Europe ranges from 1% to 11%, with an average of 4.4%, said Dr. Tereshchenko.
 

Siberian students’ sleep

The current study included 4,344 students aged 12-18 years (average age, about 15 years) from 10 public schools in three large cities of Central Siberia (Krasnoyarsk, Abakan, and Kyzyl). There were slightly more girls than boys in the study sample.

Participants completed the Russian language version of the Chen Internet Addiction Scale (CIAS), which covers five symptomatic criteria for addictive behavior: withdrawal symptoms, signs of tolerance, compulsive use, psychological or physical problems, and difficulty managing time.

In this questionnaire, respondents rate several statements regarding the effect of internet use, each on a 4-point Likert scale: not at all (1 point), a little bit (2 points), moderately (3 points) and extremely (4). The total score ranges from 26 to 104.

A CIAS score of 26-42 indicates adaptive internet use, 43-64 indicates maladaptive internet use, and 65 and above indicates pathological internet use (PIU), which was classified as “internet-addicted.”

The researchers also used the nine-item Social Media Disorder Scale, as well as the Pittsburgh Sleep Quality Index to assess nighttime sleep.

Among other questions, teens were asked how long it usually took them to fall asleep and when they typically went to bed and woke up on school nights.

For daytime sleepiness, investigators used the targeted Pediatric Daytime Sleepiness Scale questionnaire, making them among the few research groups to use this psychometric instrument, Dr. Tereshchenko noted.

After parental consent was given, students completed the tests at the end of the day’s lessons. Total test time was about 45 minutes.
 

Sleep disturbance

Initial study results showed that compared with the other groups, adolescents with PIU tended to go to bed later, wake up later, take longer to fall asleep, sleep less at night, have more nighttime awakenings, and have more daytime sleepiness.

Sleep quality was the most impaired in boys aged 12-14 years who are addicted to internet computer games.

“In this group, 5 of the 6 sleep assessment parameters we studied were changed,” Dr. Tereshchenko reported.

Decreased total nighttime sleep was more common in older adolescents.

On average, boys and girls aged 15-18 years got less than the recommended 8 hours of sleep per night. Boys with IA got only about 6.4 hours per night and girls with IA got about 6.6 hours.

Interestingly, IA is generally more prevalent among teen girls than boys in Russia, which is not the case in Europe and North America, Dr. Tereshchenko noted.

Mechanisms linking IA and sleep disorders are not clear, but the relationship is probably multifactorial and perhaps interrelated, creating something of a “vicious circle,” he said.

“Sleep disturbances, which reflect psychosocial problems, depression, and anxiety-phobic disorders, can precede and contribute to IA. On the other hand, sleep disturbances such as insomnia can lead to increased use of the internet in the evening and at night, further exacerbating the problem,” said Dr. Tereshchenko.

Research is lacking on useful treatments for youth with IA, but these kids would likely benefit from behavioral therapy approaches, he added.
 

No escape?

Commenting on the study for this news organization, Maurice M. Ohayon, MD, DSc, PhD, director of the Stanford Sleep Epidemiology Research Center, Stanford University, California, said the topic of youth IA is “very important.”

Previous research in this field has shown a major impact from IA not only on sleep but also on mood – with irritability, depression, and even thoughts of suicide being possible red flags, said Dr. Ohayon, who was not involved in the current study.

Interestingly, his own research has also found that young teenage boys are most at risk for gaming addiction.

Although internet gaming has some positive effects, such as fostering leadership skills and relationships, it has become increasingly violent and isolating, with more adult professional gamers preying on younger players, Dr. Ohayon said.

“The major problem is that it’s putting children in a virtual world from which it’s difficult to escape,” he added.

Dr. Ohayon also noted concern about future developmental effects in kids who play video games for hours on end without coming out of their bedroom and with no physical contact with fellow players.

Parents should intervene before this situation occurs and limit the time their children spend on the gaming console, he said.

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

More evidence suggests the severity of internet addiction (IA) is directly related to the severity of sleep problems in youth.

Results from a study of more than 4,000 adolescent students show IA severity was linked to less sleep and to daytime sleepiness. In addition, boys aged 12-14 years who were addicted to computer games versus social media networking were the most affected.

Sleep issues could be “easily detectable manifestations of pathological internet addiction,” investigator Sergey Tereshchenko, PhD, Scientific Research Institute for Medical Problems of the North, Krasnoyask State Medical University, Russia, told this news organization.

These sleep problems require attention and correction, Dr. Tereshchenko added.

The findings were presented at the virtual Congress of the European Academy of Neurology 2021.
 

New phenomenon

IA is a relatively new psychological phenomenon and is most prevalent in “socially vulnerable groups,” such as adolescents, Dr. Tereshchenko said.

He cited numerous studies that have “convincingly demonstrated” IA is comorbid with a broad range of psychopathologic conditions, including depression, anxiety, and attention deficit hyperactivity disorder.

There is also growing evidence, including from systematic reviews in 2014 and 2019, that IA affects a wide range of sleep parameters.

However, most studies in adolescents have used only one psychometric tool to assess addiction, revealing only the “general IA pattern” and not the type of IA, Dr. Tereshchenko noted.

Adolescents may not be addicted to the internet itself but to certain behaviors like gaming or social networking, he said.

The “undoubted advantage” of his team’s research is the use of more than one tool, making it possible to “verify the predominant content of the addiction,” he added.

The investigators previously assessed general prevalence of IA in adolescents in Siberia and found about 6.8% of participants displayed pathological IA behavior – and that gaming addiction is more common in boys whereas addiction to social networking is more common in girls.

This prevalence rate is lower than in the Philippines (21.1%), Hong Kong (16.4%), Malaysia (14.1%), China (11%), and South Korea (9.7%), but slightly higher than in Japan (6.2%).

IA prevalence among adolescents in Europe ranges from 1% to 11%, with an average of 4.4%, said Dr. Tereshchenko.
 

Siberian students’ sleep

The current study included 4,344 students aged 12-18 years (average age, about 15 years) from 10 public schools in three large cities of Central Siberia (Krasnoyarsk, Abakan, and Kyzyl). There were slightly more girls than boys in the study sample.

Participants completed the Russian language version of the Chen Internet Addiction Scale (CIAS), which covers five symptomatic criteria for addictive behavior: withdrawal symptoms, signs of tolerance, compulsive use, psychological or physical problems, and difficulty managing time.

In this questionnaire, respondents rate several statements regarding the effect of internet use, each on a 4-point Likert scale: not at all (1 point), a little bit (2 points), moderately (3 points) and extremely (4). The total score ranges from 26 to 104.

A CIAS score of 26-42 indicates adaptive internet use, 43-64 indicates maladaptive internet use, and 65 and above indicates pathological internet use (PIU), which was classified as “internet-addicted.”

The researchers also used the nine-item Social Media Disorder Scale, as well as the Pittsburgh Sleep Quality Index to assess nighttime sleep.

Among other questions, teens were asked how long it usually took them to fall asleep and when they typically went to bed and woke up on school nights.

For daytime sleepiness, investigators used the targeted Pediatric Daytime Sleepiness Scale questionnaire, making them among the few research groups to use this psychometric instrument, Dr. Tereshchenko noted.

After parental consent was given, students completed the tests at the end of the day’s lessons. Total test time was about 45 minutes.
 

Sleep disturbance

Initial study results showed that compared with the other groups, adolescents with PIU tended to go to bed later, wake up later, take longer to fall asleep, sleep less at night, have more nighttime awakenings, and have more daytime sleepiness.

Sleep quality was the most impaired in boys aged 12-14 years who are addicted to internet computer games.

“In this group, 5 of the 6 sleep assessment parameters we studied were changed,” Dr. Tereshchenko reported.

Decreased total nighttime sleep was more common in older adolescents.

On average, boys and girls aged 15-18 years got less than the recommended 8 hours of sleep per night. Boys with IA got only about 6.4 hours per night and girls with IA got about 6.6 hours.

Interestingly, IA is generally more prevalent among teen girls than boys in Russia, which is not the case in Europe and North America, Dr. Tereshchenko noted.

Mechanisms linking IA and sleep disorders are not clear, but the relationship is probably multifactorial and perhaps interrelated, creating something of a “vicious circle,” he said.

“Sleep disturbances, which reflect psychosocial problems, depression, and anxiety-phobic disorders, can precede and contribute to IA. On the other hand, sleep disturbances such as insomnia can lead to increased use of the internet in the evening and at night, further exacerbating the problem,” said Dr. Tereshchenko.

Research is lacking on useful treatments for youth with IA, but these kids would likely benefit from behavioral therapy approaches, he added.
 

No escape?

Commenting on the study for this news organization, Maurice M. Ohayon, MD, DSc, PhD, director of the Stanford Sleep Epidemiology Research Center, Stanford University, California, said the topic of youth IA is “very important.”

Previous research in this field has shown a major impact from IA not only on sleep but also on mood – with irritability, depression, and even thoughts of suicide being possible red flags, said Dr. Ohayon, who was not involved in the current study.

Interestingly, his own research has also found that young teenage boys are most at risk for gaming addiction.

Although internet gaming has some positive effects, such as fostering leadership skills and relationships, it has become increasingly violent and isolating, with more adult professional gamers preying on younger players, Dr. Ohayon said.

“The major problem is that it’s putting children in a virtual world from which it’s difficult to escape,” he added.

Dr. Ohayon also noted concern about future developmental effects in kids who play video games for hours on end without coming out of their bedroom and with no physical contact with fellow players.

Parents should intervene before this situation occurs and limit the time their children spend on the gaming console, he said.

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

More evidence suggests the severity of internet addiction (IA) is directly related to the severity of sleep problems in youth.

Results from a study of more than 4,000 adolescent students show IA severity was linked to less sleep and to daytime sleepiness. In addition, boys aged 12-14 years who were addicted to computer games versus social media networking were the most affected.

Sleep issues could be “easily detectable manifestations of pathological internet addiction,” investigator Sergey Tereshchenko, PhD, Scientific Research Institute for Medical Problems of the North, Krasnoyask State Medical University, Russia, told this news organization.

These sleep problems require attention and correction, Dr. Tereshchenko added.

The findings were presented at the virtual Congress of the European Academy of Neurology 2021.
 

New phenomenon

IA is a relatively new psychological phenomenon and is most prevalent in “socially vulnerable groups,” such as adolescents, Dr. Tereshchenko said.

He cited numerous studies that have “convincingly demonstrated” IA is comorbid with a broad range of psychopathologic conditions, including depression, anxiety, and attention deficit hyperactivity disorder.

There is also growing evidence, including from systematic reviews in 2014 and 2019, that IA affects a wide range of sleep parameters.

However, most studies in adolescents have used only one psychometric tool to assess addiction, revealing only the “general IA pattern” and not the type of IA, Dr. Tereshchenko noted.

Adolescents may not be addicted to the internet itself but to certain behaviors like gaming or social networking, he said.

The “undoubted advantage” of his team’s research is the use of more than one tool, making it possible to “verify the predominant content of the addiction,” he added.

The investigators previously assessed general prevalence of IA in adolescents in Siberia and found about 6.8% of participants displayed pathological IA behavior – and that gaming addiction is more common in boys whereas addiction to social networking is more common in girls.

This prevalence rate is lower than in the Philippines (21.1%), Hong Kong (16.4%), Malaysia (14.1%), China (11%), and South Korea (9.7%), but slightly higher than in Japan (6.2%).

IA prevalence among adolescents in Europe ranges from 1% to 11%, with an average of 4.4%, said Dr. Tereshchenko.
 

Siberian students’ sleep

The current study included 4,344 students aged 12-18 years (average age, about 15 years) from 10 public schools in three large cities of Central Siberia (Krasnoyarsk, Abakan, and Kyzyl). There were slightly more girls than boys in the study sample.

Participants completed the Russian language version of the Chen Internet Addiction Scale (CIAS), which covers five symptomatic criteria for addictive behavior: withdrawal symptoms, signs of tolerance, compulsive use, psychological or physical problems, and difficulty managing time.

In this questionnaire, respondents rate several statements regarding the effect of internet use, each on a 4-point Likert scale: not at all (1 point), a little bit (2 points), moderately (3 points) and extremely (4). The total score ranges from 26 to 104.

A CIAS score of 26-42 indicates adaptive internet use, 43-64 indicates maladaptive internet use, and 65 and above indicates pathological internet use (PIU), which was classified as “internet-addicted.”

The researchers also used the nine-item Social Media Disorder Scale, as well as the Pittsburgh Sleep Quality Index to assess nighttime sleep.

Among other questions, teens were asked how long it usually took them to fall asleep and when they typically went to bed and woke up on school nights.

For daytime sleepiness, investigators used the targeted Pediatric Daytime Sleepiness Scale questionnaire, making them among the few research groups to use this psychometric instrument, Dr. Tereshchenko noted.

After parental consent was given, students completed the tests at the end of the day’s lessons. Total test time was about 45 minutes.
 

Sleep disturbance

Initial study results showed that compared with the other groups, adolescents with PIU tended to go to bed later, wake up later, take longer to fall asleep, sleep less at night, have more nighttime awakenings, and have more daytime sleepiness.

Sleep quality was the most impaired in boys aged 12-14 years who are addicted to internet computer games.

“In this group, 5 of the 6 sleep assessment parameters we studied were changed,” Dr. Tereshchenko reported.

Decreased total nighttime sleep was more common in older adolescents.

On average, boys and girls aged 15-18 years got less than the recommended 8 hours of sleep per night. Boys with IA got only about 6.4 hours per night and girls with IA got about 6.6 hours.

Interestingly, IA is generally more prevalent among teen girls than boys in Russia, which is not the case in Europe and North America, Dr. Tereshchenko noted.

Mechanisms linking IA and sleep disorders are not clear, but the relationship is probably multifactorial and perhaps interrelated, creating something of a “vicious circle,” he said.

“Sleep disturbances, which reflect psychosocial problems, depression, and anxiety-phobic disorders, can precede and contribute to IA. On the other hand, sleep disturbances such as insomnia can lead to increased use of the internet in the evening and at night, further exacerbating the problem,” said Dr. Tereshchenko.

Research is lacking on useful treatments for youth with IA, but these kids would likely benefit from behavioral therapy approaches, he added.
 

No escape?

Commenting on the study for this news organization, Maurice M. Ohayon, MD, DSc, PhD, director of the Stanford Sleep Epidemiology Research Center, Stanford University, California, said the topic of youth IA is “very important.”

Previous research in this field has shown a major impact from IA not only on sleep but also on mood – with irritability, depression, and even thoughts of suicide being possible red flags, said Dr. Ohayon, who was not involved in the current study.

Interestingly, his own research has also found that young teenage boys are most at risk for gaming addiction.

Although internet gaming has some positive effects, such as fostering leadership skills and relationships, it has become increasingly violent and isolating, with more adult professional gamers preying on younger players, Dr. Ohayon said.

“The major problem is that it’s putting children in a virtual world from which it’s difficult to escape,” he added.

Dr. Ohayon also noted concern about future developmental effects in kids who play video games for hours on end without coming out of their bedroom and with no physical contact with fellow players.

Parents should intervene before this situation occurs and limit the time their children spend on the gaming console, he said.

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

Tardive dyskinesia (TD) can be reasonably managed through telemedicine, but it should be employed as part of a hybrid strategy that ideally includes an office visit at the time of diagnosis and yearly intervals thereafter, according to an expert who spoke at a meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

verbaska_studio/Getty Images

In psychiatry in general and in TD specifically, telepsychiatry is useful, but “is not a one-size-fits-all approach,” according to Rif S. El-Mallakh, MD, director of the mood disorder research program at the University of Louisville (Ky.).

Telepsychiatry was already growing as a strategy to expand psychiatric services to communities with limited resources in mental health when the COVID-19 pandemic arrived. Dependence on this type of patient care then exploded out of necessity but in advance of how it might best be applied in specific circumstances.
 

Best practices panel convened in 2020

The project to develop best practices in TD began in July 2020, when the pandemic was still limiting normal clinician-patient interactions. It was expected from the beginning that recommendations would be applicable to postpandemic circumstances.

There is no reason to expect the forces driving the growth of telepsychiatry, which include convenience of patients and efficiency for clinicians, to dissipate once the pandemic resolves, Dr. El-Mallakh said at the virtual meeting, sponsored by MedscapeLive.

The process of developing best practices for telepsychiatry in TD began with semistructured qualitative interviews of the panelists, which consisted of six neurologists, three psychiatrists, and three psychiatric nurse practitioners. The goal was to gather information about the current practice of TD diagnosis and treatment in real-world settings.

With the information on current practices providing a baseline, a virtual roundtable was then convened to develop best-practices recommendations. The deliberations were performed on the basis of expert opinion. There were no statistical methods applied to data collected from the qualitative interviews.
 

Four key points in recommendations

The panel agreed on four key points: an in-person visit is preferred for initial evaluation and diagnosis; when applied for the evaluation of TD, telepsychiatry should include video; virtual visits cannot completely replace in-person visits; and patients with TD should be evaluated in person at least once per year.

In addition, the panelists recommended specific steps aimed at maximizing the quality of the virtual visit, including confirming that patients have appropriate equipment for video and audio communication. It is also important to recognize that patients or caregivers may require instruction on how to set up the equipment.

Prior to a telemedicine visit, it is appropriate to provide patients with a checklist that includes instructions on adequate lighting and audio. In addition, patient expectations about the goals and processes in the video should be explained.

“Instructional videos prior to the visit might be helpful,” Dr. El-Mallakh said.

Immediately prior to each visit, visual and audio quality should be verified. This allows technical issues, if any, to be resolved.

For the evaluation of TD, the ability to adequately observe body movements is crucial but can pose a challenge in telepsychiatry. To capture hyperkinetic movements and functional impairments with adequate clarity, it might be necessary to engage caregivers to hold the camera or otherwise help the clinician gain an adequate view. Clinicians should consider the limitations of telepsychiatry.

In addition to the challenges of a differential diagnosis for TD that should include such entities as parkinsonism and other drug-induced movement disorders, Dr. El-Mallakh cautioned, “comorbidities add another layer of complexity to TD diagnosis.”
 

Some in-office visits recommended

It is this complexity that led to the recommendation for an in-person evaluation for new-onset TD, although the expert panel did not characterize an initial in-office visit as mandatory.

Once a diagnosis of TD is established, telepsychiatry can be an efficient strategy for education and for confirming that treatments remain effective. However, Dr. El-Mallakh pointed out that patients can and often do have more than one drug-induced movement disorder at the time of diagnosis or develop additional clinical issues over time.

According to the expert panel, telepsychiatry should not be considered an adequate strategy to manage TD by itself, but “it can be an important component” of care of these patients if used judiciously.

“We have all come to recognize the benefits of telepsychiatry and some of the limitations,” said Jonathan M. Meyer, MD, clinical professor of psychiatry, University of California, San Diego. An author or coauthor of several articles on TD, including a recent study of patient awareness of TD symptoms while on vesicular monoamine transporter 2 inhibitors, Dr. Meyer identified technical problems as among the limitations.

Doug Brunk/MDedge News

Tardive dyskinesia (TD) can be reasonably managed through telemedicine, but it should be employed as part of a hybrid strategy that ideally includes an office visit at the time of diagnosis and yearly intervals thereafter, according to an expert who spoke at a meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

verbaska_studio/Getty Images

In psychiatry in general and in TD specifically, telepsychiatry is useful, but “is not a one-size-fits-all approach,” according to Rif S. El-Mallakh, MD, director of the mood disorder research program at the University of Louisville (Ky.).

Telepsychiatry was already growing as a strategy to expand psychiatric services to communities with limited resources in mental health when the COVID-19 pandemic arrived. Dependence on this type of patient care then exploded out of necessity but in advance of how it might best be applied in specific circumstances.
 

Best practices panel convened in 2020

The project to develop best practices in TD began in July 2020, when the pandemic was still limiting normal clinician-patient interactions. It was expected from the beginning that recommendations would be applicable to postpandemic circumstances.

There is no reason to expect the forces driving the growth of telepsychiatry, which include convenience of patients and efficiency for clinicians, to dissipate once the pandemic resolves, Dr. El-Mallakh said at the virtual meeting, sponsored by MedscapeLive.

The process of developing best practices for telepsychiatry in TD began with semistructured qualitative interviews of the panelists, which consisted of six neurologists, three psychiatrists, and three psychiatric nurse practitioners. The goal was to gather information about the current practice of TD diagnosis and treatment in real-world settings.

With the information on current practices providing a baseline, a virtual roundtable was then convened to develop best-practices recommendations. The deliberations were performed on the basis of expert opinion. There were no statistical methods applied to data collected from the qualitative interviews.
 

Four key points in recommendations

The panel agreed on four key points: an in-person visit is preferred for initial evaluation and diagnosis; when applied for the evaluation of TD, telepsychiatry should include video; virtual visits cannot completely replace in-person visits; and patients with TD should be evaluated in person at least once per year.

In addition, the panelists recommended specific steps aimed at maximizing the quality of the virtual visit, including confirming that patients have appropriate equipment for video and audio communication. It is also important to recognize that patients or caregivers may require instruction on how to set up the equipment.

Prior to a telemedicine visit, it is appropriate to provide patients with a checklist that includes instructions on adequate lighting and audio. In addition, patient expectations about the goals and processes in the video should be explained.

“Instructional videos prior to the visit might be helpful,” Dr. El-Mallakh said.

Immediately prior to each visit, visual and audio quality should be verified. This allows technical issues, if any, to be resolved.

For the evaluation of TD, the ability to adequately observe body movements is crucial but can pose a challenge in telepsychiatry. To capture hyperkinetic movements and functional impairments with adequate clarity, it might be necessary to engage caregivers to hold the camera or otherwise help the clinician gain an adequate view. Clinicians should consider the limitations of telepsychiatry.

In addition to the challenges of a differential diagnosis for TD that should include such entities as parkinsonism and other drug-induced movement disorders, Dr. El-Mallakh cautioned, “comorbidities add another layer of complexity to TD diagnosis.”
 

Some in-office visits recommended

It is this complexity that led to the recommendation for an in-person evaluation for new-onset TD, although the expert panel did not characterize an initial in-office visit as mandatory.

Once a diagnosis of TD is established, telepsychiatry can be an efficient strategy for education and for confirming that treatments remain effective. However, Dr. El-Mallakh pointed out that patients can and often do have more than one drug-induced movement disorder at the time of diagnosis or develop additional clinical issues over time.

According to the expert panel, telepsychiatry should not be considered an adequate strategy to manage TD by itself, but “it can be an important component” of care of these patients if used judiciously.

“We have all come to recognize the benefits of telepsychiatry and some of the limitations,” said Jonathan M. Meyer, MD, clinical professor of psychiatry, University of California, San Diego. An author or coauthor of several articles on TD, including a recent study of patient awareness of TD symptoms while on vesicular monoamine transporter 2 inhibitors, Dr. Meyer identified technical problems as among the limitations.

Doug Brunk/MDedge News

Tardive dyskinesia (TD) can be reasonably managed through telemedicine, but it should be employed as part of a hybrid strategy that ideally includes an office visit at the time of diagnosis and yearly intervals thereafter, according to an expert who spoke at a meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

verbaska_studio/Getty Images

In psychiatry in general and in TD specifically, telepsychiatry is useful, but “is not a one-size-fits-all approach,” according to Rif S. El-Mallakh, MD, director of the mood disorder research program at the University of Louisville (Ky.).

Telepsychiatry was already growing as a strategy to expand psychiatric services to communities with limited resources in mental health when the COVID-19 pandemic arrived. Dependence on this type of patient care then exploded out of necessity but in advance of how it might best be applied in specific circumstances.
 

Best practices panel convened in 2020

The project to develop best practices in TD began in July 2020, when the pandemic was still limiting normal clinician-patient interactions. It was expected from the beginning that recommendations would be applicable to postpandemic circumstances.

There is no reason to expect the forces driving the growth of telepsychiatry, which include convenience of patients and efficiency for clinicians, to dissipate once the pandemic resolves, Dr. El-Mallakh said at the virtual meeting, sponsored by MedscapeLive.

The process of developing best practices for telepsychiatry in TD began with semistructured qualitative interviews of the panelists, which consisted of six neurologists, three psychiatrists, and three psychiatric nurse practitioners. The goal was to gather information about the current practice of TD diagnosis and treatment in real-world settings.

With the information on current practices providing a baseline, a virtual roundtable was then convened to develop best-practices recommendations. The deliberations were performed on the basis of expert opinion. There were no statistical methods applied to data collected from the qualitative interviews.
 

Four key points in recommendations

The panel agreed on four key points: an in-person visit is preferred for initial evaluation and diagnosis; when applied for the evaluation of TD, telepsychiatry should include video; virtual visits cannot completely replace in-person visits; and patients with TD should be evaluated in person at least once per year.

In addition, the panelists recommended specific steps aimed at maximizing the quality of the virtual visit, including confirming that patients have appropriate equipment for video and audio communication. It is also important to recognize that patients or caregivers may require instruction on how to set up the equipment.

Prior to a telemedicine visit, it is appropriate to provide patients with a checklist that includes instructions on adequate lighting and audio. In addition, patient expectations about the goals and processes in the video should be explained.

“Instructional videos prior to the visit might be helpful,” Dr. El-Mallakh said.

Immediately prior to each visit, visual and audio quality should be verified. This allows technical issues, if any, to be resolved.

For the evaluation of TD, the ability to adequately observe body movements is crucial but can pose a challenge in telepsychiatry. To capture hyperkinetic movements and functional impairments with adequate clarity, it might be necessary to engage caregivers to hold the camera or otherwise help the clinician gain an adequate view. Clinicians should consider the limitations of telepsychiatry.

In addition to the challenges of a differential diagnosis for TD that should include such entities as parkinsonism and other drug-induced movement disorders, Dr. El-Mallakh cautioned, “comorbidities add another layer of complexity to TD diagnosis.”
 

Some in-office visits recommended

It is this complexity that led to the recommendation for an in-person evaluation for new-onset TD, although the expert panel did not characterize an initial in-office visit as mandatory.

Once a diagnosis of TD is established, telepsychiatry can be an efficient strategy for education and for confirming that treatments remain effective. However, Dr. El-Mallakh pointed out that patients can and often do have more than one drug-induced movement disorder at the time of diagnosis or develop additional clinical issues over time.

According to the expert panel, telepsychiatry should not be considered an adequate strategy to manage TD by itself, but “it can be an important component” of care of these patients if used judiciously.

“We have all come to recognize the benefits of telepsychiatry and some of the limitations,” said Jonathan M. Meyer, MD, clinical professor of psychiatry, University of California, San Diego. An author or coauthor of several articles on TD, including a recent study of patient awareness of TD symptoms while on vesicular monoamine transporter 2 inhibitors, Dr. Meyer identified technical problems as among the limitations.

Doug Brunk/MDedge News

It was a 95° F day in July 2015, and emergency physician Martin Maag, MD, was driving down Bee Ridge Road, a busy seven-lane thoroughfare in Sarasota, Fla., on his way home from a family dinner. To distance himself from a truck blowing black smoke, Dr. Maag says he had just passed some vehicles, when a motorcycle flew past him in the turning lane and the passenger flipped him off.

“I started laughing because I knew we were coming up to a red light,” said Dr. Maag. “When we pulled up to the light, I put my window down and said: ‘Hey, you ought to be a little more careful about who you’re flipping off! You never know who it might be and what they might do.’ ”

The female passenger cursed at Dr. Maag, and the two traded profanities. The male driver then told Dr. Maag: “Get out of the car, old man,” according to Dr. Maag. Fuming, Dr. Maag got out of his black Tesla, and the two men met in the middle of the street.

“As soon as I got close enough to see him, I could tell he really looked young,” Dr. Maag recalls. “I said: ‘You’re like 12 years old. I’m going to end up beating your ass and then I’m going to go to jail. Go get on your bike, and ride home to your mom.’ I don’t remember what he said to me, but I spun around and said: ‘If you want to act like a man, meet me up the street in a parking lot and let’s have at it like men.’ ”

The motorcyclist got back on his white Suzuki and sped off, and Dr. Maag followed. Both vehicles went racing down the road, swerving between cars, and reaching speeds of 100 miles per hour, Dr. Maag said. At one point, Dr. Maag says he drove in front of the motorcyclist to slow him down, and the motorcycle clipped the back of his car. No one was seriously hurt, but soon Dr. Maag was in the back of a police cruiser headed to jail.

Dr. Maag wishes he could take back his actions that summer day 6 years ago. Those few minutes of fury have had lasting effects on the doctor’s life. The incident resulted in criminal charges, a jail sentence, thousands of dollars in legal fees, and a 3-year departure from emergency medicine. Although Dr. Maag did not lose his medical license as a result of the incident, the physician’s Medicare billing privileges were suspended because of a federal provision that ties some felonies to enrollment revocations.

Dr. Maag, 61, shared his story with this news organization to warn other physicians about the wide-ranging career ramifications that can happen as a result of offenses unrelated to medicine. 

“Every doctor, every health professional needs to know that there are a lot of consequences that go with our actions outside of work,” he said. “In my situation, what happened had nothing to do with medicine, it had nothing to do with patients, it had nothing to do my professional demeanor. But yet it affected my entire career, and I lost the ability to practice emergency medicine for 3 years. Three years for any doctor is a long time. Three years for emergency medicine is a lifetime.”
 

The physician ends up in jail

After the collision, Dr. Maag pulled over in a parking lot and dialed 911. Several passing motorists did the same. It appeared the biker was trying to get away, and Dr. Maag was concerned about the damage to his Tesla, he said. 

When police arrived, they heard very different accounts of what happened. The motorcyclist and his girlfriend claimed Dr. Maag was the aggressor during the altercation, and that he deliberately tried to hit them with his vehicle. Two witnesses at the scene said they had watched Dr. Maag pursue the motorcycle in his vehicle, and that they believed he crossed into their lane intentionally to strike the motorcycle, according to police reports.

“[The motorcyclist] stated that the vehicle struck his right foot when it hit the motorcycle and that he was able to keep his balance and not lay the bike down,” Sarasota County Deputy C. Moore wrote in his report. “The motorcycle was damaged on the right side near [his] foot, verifying his story. Both victims were adamant that the defendant actually and intentionally struck the motorcycle with his car due to the previous altercation.”

Dr. Maag told officers the motorcyclist had initiated the confrontation. He acknowledged racing after the biker, but said it was the motorcyclist who hit his vehicle. In an interview, Dr. Maag disputed the witnesses’ accounts, saying that one of the witnesses was without a car and made claims to police that were impossible from her distance. 

In the end, the officer believed the motorcyclist, writing in his report that the damage to the Tesla was consistent with the biker’s version of events. Dr. Maag was handcuffed and taken to the Sarasota County Jail.

“I was in shock,” he said. “When we got to the jail, they got me booked in and fingerprinted. I sat down and said [to an officer]: ‘So, when do I get to bond out?’ The guy started laughing and said: ‘You’re not going anywhere. You’re spending the night in jail, my friend.’ He said: ‘Your charge is one step below murder.’”
 

‘I like to drive fast’

Aside from speeding tickets, Dr. Maag said he had never been in serious trouble with the law before.

The husband and father of two has practiced emergency medicine for more 15 years, and his license has remained in good standing. Florida Department of Health records show Dr. Maag’s medical license as clear and active with no discipline cases or public complaints on file.

“I did my best for every patient that came through that door,” he said. “There were a lot of people who didn’t like my personality. I’ve said many times: ‘I’m not here to be liked. I’m here to take care of people and provide the best care possible.’ ” 

Sarasota County records show that Dr. Maag has received traffic citations in the past for careless driving, unlawful speed, and failure to stop at a red light, among others. He admits to having a “lead foot,” but says he had never before been involved in a road rage incident.

“I’m not going to lie, I like to drive fast,” he said. “I like that feeling. It just seems to slow everything down for me, the faster I’m going.”

After being booked into jail that July evening in 2015, Dr. Maag called his wife to explain what happened.

“She said, ‘I can’t believe you’ve done this. I’ve told you a million times, don’t worry about how other people drive. Keep your mouth shut,’” he recalled. “I asked her to call my work and let them know I wouldn’t be coming in the next day. Until that happened, I had never missed a day of work since becoming a physician.”

After an anxious night in his jail cell, Dr. Maag lined up with the other inmates the next morning for his bond hearing. His charges included felony, aggravated battery, and felony aggravated assault with a deadly weapon. A prosecutor recommended Dr. Maag’s bond be set at $1 million, which a judge lowered to $500,000.

Michael Fayard, a criminal defense attorney who represented Dr. Maag in the case, said even with the reduction, $500,000 was an outrageous bond for such a case.

“The prosecutor’s arguments to the judge were that he was a physician driving a Tesla,” Mr. Fayard said. “That was his exact argument for charging him a higher bond. It shouldn’t have been that high. I argued he was not a flight risk. He didn’t even have a passport.”

The Florida State Attorney’s Office did not return messages seeking comment about the case.

Dr. Maag spent 2 more nights in jail while he and his wife came up with $50,000 in cash, in accordance with the 10% bond rule. In the meantime, the government put a lien on their house. A circuit court judge later agreed the bond was excessive, according to Mr. Fayard, but by that time, the $50,000 was paid and Dr. Maag was released.
 

New evidence lowers charges 

Dr. Maag ultimately accepted a plea deal from the prosecutor’s office and pled no contest to one count of felony criminal mischief and one count of misdemeanor reckless driving. In return, the state dropped the two more serious felonies. A no-contest plea is not considered an admission of guilt.

Mr. Fayard said his investigation into the road rage victim unearthed evidence that poked holes in the motorcyclist’s credibility, and that contributed to the plea offer.

“We found tons of evidence about the kid being a hot-rodding rider on his motorcycle, videos of him traveling 140 miles an hour, popping wheelies, and darting in and out of traffic,” he said. “There was a lot of mitigation that came up during the course of the investigation.”

The plea deal was a favorable result for Dr. Maag considering his original charges, Mr. Fayard said. He added that the criminal case could have ended much differently.

“Given the facts of this case and given the fact that there were no serious injuries, we supported the state’s decision to accept our mitigation and come out with the sentence that they did,” Mr. Fayard said. “If there would have been injuries, the outcome would have likely been much worse for Dr. Maag.”

With the plea agreement reached, Dr. Maag faced his next consequence – jail time. He was sentenced to 60 days in jail, a $1,000 fine, 12 months of probation, and 8 months of house arrest. Unlike his first jail stay, Dr. Maag said the second, longer stint behind bars was more relaxing. 

“It was the first time since I had become an emergency physician that I remember my dreams,” he recalled. “I had nothing to worry about, nothing to do. All I had to do was get up and eat. Every now and then, I would mop the floors because I’m kind of a clean freak, and I would talk to guys and that was it. It wasn’t bad at all.”

Dr. Maag told no one that he was a doctor because he didn’t want to be treated differently. The anonymity led to interesting tidbits from other inmates about the best pill mills in the area for example, how to make crack cocaine, and selling items for drugs. On his last day in jail, the other inmates learned from his discharge paperwork that Dr. Maag was a physician.

“One of the corrections officers said: ‘You’re a doctor? We’ve never had a doctor in here before!’” Dr. Maag remembers. “He said: ‘What did a doctor do to get into jail?’ I said: ‘Do you really want to know?’ ”

About the time that Dr. Maag was released from jail, the Florida Board of Medicine learned of his charges and began reviewing his case. Mr. Fayard presented the same facts to the board and argued for Dr. Maag to keep his license, emphasizing the offenses in which he was convicted were significantly less severe than the original felonies charged. The board agreed to dismiss the case. 

“The probable cause panel for the board of medicine considered the complaint that has been filed against your client in the above referenced case,” Peter Delia, then-assistant general counsel for the Florida Department of Health, wrote in a letter dated April 27, 2016. “After careful review of all information and evidence obtained in this case, the panel determined that probable cause of a violation does not exist and directed this case to be closed.”
 

A short-lived celebration

Once home, Dr. Maag was on house arrest, but he was granted permission to travel for work. He continued to practice emergency medicine. After several months, authorities dropped the house arrest, and a judge canceled his probation early. It appeared the road rage incident was finally behind him. 

But a year later, in 2018, the doctor received a letter from the Centers for Medicare & Medicaid Services informing him that because of his charges, his Medicare number had been revoked in November 2015.

“It took them 3 years to find me and tell me, even though I never moved,” he said. “Medicare said because I never reported this, they were hitting me up with falsification of documentation because I had signed other Medicare paperwork saying I had never been barred from Medicare, because I didn’t know that I was.”

Dr. Maag hired a different attorney to help him fight the 3-year enrollment ban. He requested reconsideration from CMS, but a hearing officer in October 2017 upheld the revocation. Because his privileges had been revoked in 2015, Dr. Maag’s practice group had to return all money billed by Dr. Maag to Medicare over the 3-year period, which totaled about $190,000.

A CMS spokeswoman declined to comment about Dr. Maag’s case, referring a reporter for this news organization to an administrative law judge’s decision that summarizes the agency’s findings.

According to the summary, in separate reconsidered determinations, the CMS hearing officer concluded that the revocation was proper under section 424.535(a)(3). The regulation, enacted in 2011, allows CMS to revoke billing privileges if a provider was convicted of a federal or state felony within the preceding 10 years that the agency determines is detrimental to the Medicare program and its beneficiaries.

The hearing officer reasoned that Dr. Maag “had been convicted of a felony that is akin to assault and, even if it were not, his actions showed a reckless disregard for the safety of others.” She concluded also that CMS could appropriately revoke Dr. Maag’s Medicare enrollment because he did not report his felony conviction within 30 days as required.

Dr. Maag went through several phases of fighting the revocation, including an appeal to the Department of Health & Human Services Departmental Appeals Board. He argued that his plea was a no-contest plea, which is not considered an admission of guilt. Dr. Maag and his attorney provided CMS a 15-page paper about his background, education, career accomplishments, and patient care history. They emphasized that Dr. Maag had never harmed or threatened a patient, and that his offense had nothing to do with his practice.

In February 2021, Judge Carolyn Cozad Hughes, an administrative law judge with CMS, upheld the 3-year revocation. In her decision, she wrote that for purposes of revocation under CMS law, “convicted” means that a judgment of conviction has been entered by a federal, state, or local court regardless of whether the judgment of conviction has been expunged or otherwise removed. She disagreed with Dr. Maag’s contention that his was a crime against property and, therefore, not akin to any of the felony offenses enumerated under the revocation section, which are crimes against persons.

“Even disregarding the allegations contained in the probable cause affidavit, Petitioner cannot escape the undisputed fact, established by his conviction and his own admissions, that the ‘property’ he so ‘willfully and maliciously’ damaged was a motorcycle traveling at a high rate of speed, and, that two young people were sitting atop that motorcycle,” Judge Hughes wrote. “Moreover, as part of the same conduct, he was charged – and convicted – of misdemeanor reckless driving with ‘willful and wanton disregard for the safety of persons or property.’ Thus, even accepting Petitioner’s description of the events, he unquestionably showed no regard for the safety of the young people on that motorcycle.”

Judge Hughes noted that, although Dr. Maag’s crimes may not be among those specified in the regulation, CMS has broad authority to determine which felonies are detrimental to the best interests of the program and its beneficiaries.
 

A new career path

Unable to practice emergency medicine and beset with debt, Dr. Maag spiraled into a dark depression. His family had to start using retirement money that he was saving for the future care of his son, who has autism.

“I was suicidal,” he said. “There were two times that I came very close to going out to the woods by my house and hanging myself. All I wanted was to have everything go away. My wife saved my life.”

Slowly, Dr. Maag climbed out of the despondency and began considering new career options. After working and training briefly in hair restoration, Dr. Maag became a hair transplant specialist and opened his own hair restoration practice. It was a way to practice and help patients without having to accept Medicare. Today, he is the founder of Honest Hair Restoration in Bradenton, Fla.

Hair restoration is not the type of medicine that he “was designed to do,” Dr. Maag said, but he has embraced its advantages, such as learning about the business aspects of medicine and having a slower-paced work life. The business, which opened in 2019, is doing well and growing steadily.

Earlier this month, Dr. Maag learned CMS had reinstated his Medicare billing privileges. If an opportunity arises to go back into emergency medicine or urgent care, he is open to the possibilities, he said, but he plans to continue hair restoration for now. He hopes the lessons learned from his road rage incident may help others in similar circumstances.

“If I could go back to that very moment, I would’ve just kept my window up and I wouldn’t have said anything,” Dr. Maag said. “I would’ve kept my mouth shut and gone on about my day. Would I have loved it to have never happened? Yeah, and I’d probably be starting my retirement now. Am I stronger now? Well, I’m probably a hell of a lot wiser. But when all is said and done, I don’t want anybody feeling sorry for me. It was all my doing and I have to live with the consequences.”

Mr. Fayard, the attorney, says the case is a cautionary tale for doctors.

“No one is really above the law,” he said. “There aren’t two legal systems. You can’t just pay a little money and be done. At every level, serious charges have serious ramifications for everyone involved. Law enforcement and judges are not going to care of you’re a physician and you commit a crime. But physicians have a lot more on the line than many others. They can lose their ability to practice.”

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

It was a 95° F day in July 2015, and emergency physician Martin Maag, MD, was driving down Bee Ridge Road, a busy seven-lane thoroughfare in Sarasota, Fla., on his way home from a family dinner. To distance himself from a truck blowing black smoke, Dr. Maag says he had just passed some vehicles, when a motorcycle flew past him in the turning lane and the passenger flipped him off.

“I started laughing because I knew we were coming up to a red light,” said Dr. Maag. “When we pulled up to the light, I put my window down and said: ‘Hey, you ought to be a little more careful about who you’re flipping off! You never know who it might be and what they might do.’ ”

The female passenger cursed at Dr. Maag, and the two traded profanities. The male driver then told Dr. Maag: “Get out of the car, old man,” according to Dr. Maag. Fuming, Dr. Maag got out of his black Tesla, and the two men met in the middle of the street.

“As soon as I got close enough to see him, I could tell he really looked young,” Dr. Maag recalls. “I said: ‘You’re like 12 years old. I’m going to end up beating your ass and then I’m going to go to jail. Go get on your bike, and ride home to your mom.’ I don’t remember what he said to me, but I spun around and said: ‘If you want to act like a man, meet me up the street in a parking lot and let’s have at it like men.’ ”

The motorcyclist got back on his white Suzuki and sped off, and Dr. Maag followed. Both vehicles went racing down the road, swerving between cars, and reaching speeds of 100 miles per hour, Dr. Maag said. At one point, Dr. Maag says he drove in front of the motorcyclist to slow him down, and the motorcycle clipped the back of his car. No one was seriously hurt, but soon Dr. Maag was in the back of a police cruiser headed to jail.

Dr. Maag wishes he could take back his actions that summer day 6 years ago. Those few minutes of fury have had lasting effects on the doctor’s life. The incident resulted in criminal charges, a jail sentence, thousands of dollars in legal fees, and a 3-year departure from emergency medicine. Although Dr. Maag did not lose his medical license as a result of the incident, the physician’s Medicare billing privileges were suspended because of a federal provision that ties some felonies to enrollment revocations.

Dr. Maag, 61, shared his story with this news organization to warn other physicians about the wide-ranging career ramifications that can happen as a result of offenses unrelated to medicine. 

“Every doctor, every health professional needs to know that there are a lot of consequences that go with our actions outside of work,” he said. “In my situation, what happened had nothing to do with medicine, it had nothing to do with patients, it had nothing to do my professional demeanor. But yet it affected my entire career, and I lost the ability to practice emergency medicine for 3 years. Three years for any doctor is a long time. Three years for emergency medicine is a lifetime.”
 

The physician ends up in jail

After the collision, Dr. Maag pulled over in a parking lot and dialed 911. Several passing motorists did the same. It appeared the biker was trying to get away, and Dr. Maag was concerned about the damage to his Tesla, he said. 

When police arrived, they heard very different accounts of what happened. The motorcyclist and his girlfriend claimed Dr. Maag was the aggressor during the altercation, and that he deliberately tried to hit them with his vehicle. Two witnesses at the scene said they had watched Dr. Maag pursue the motorcycle in his vehicle, and that they believed he crossed into their lane intentionally to strike the motorcycle, according to police reports.

“[The motorcyclist] stated that the vehicle struck his right foot when it hit the motorcycle and that he was able to keep his balance and not lay the bike down,” Sarasota County Deputy C. Moore wrote in his report. “The motorcycle was damaged on the right side near [his] foot, verifying his story. Both victims were adamant that the defendant actually and intentionally struck the motorcycle with his car due to the previous altercation.”

Dr. Maag told officers the motorcyclist had initiated the confrontation. He acknowledged racing after the biker, but said it was the motorcyclist who hit his vehicle. In an interview, Dr. Maag disputed the witnesses’ accounts, saying that one of the witnesses was without a car and made claims to police that were impossible from her distance. 

In the end, the officer believed the motorcyclist, writing in his report that the damage to the Tesla was consistent with the biker’s version of events. Dr. Maag was handcuffed and taken to the Sarasota County Jail.

“I was in shock,” he said. “When we got to the jail, they got me booked in and fingerprinted. I sat down and said [to an officer]: ‘So, when do I get to bond out?’ The guy started laughing and said: ‘You’re not going anywhere. You’re spending the night in jail, my friend.’ He said: ‘Your charge is one step below murder.’”
 

‘I like to drive fast’

Aside from speeding tickets, Dr. Maag said he had never been in serious trouble with the law before.

The husband and father of two has practiced emergency medicine for more 15 years, and his license has remained in good standing. Florida Department of Health records show Dr. Maag’s medical license as clear and active with no discipline cases or public complaints on file.

“I did my best for every patient that came through that door,” he said. “There were a lot of people who didn’t like my personality. I’ve said many times: ‘I’m not here to be liked. I’m here to take care of people and provide the best care possible.’ ” 

Sarasota County records show that Dr. Maag has received traffic citations in the past for careless driving, unlawful speed, and failure to stop at a red light, among others. He admits to having a “lead foot,” but says he had never before been involved in a road rage incident.

“I’m not going to lie, I like to drive fast,” he said. “I like that feeling. It just seems to slow everything down for me, the faster I’m going.”

After being booked into jail that July evening in 2015, Dr. Maag called his wife to explain what happened.

“She said, ‘I can’t believe you’ve done this. I’ve told you a million times, don’t worry about how other people drive. Keep your mouth shut,’” he recalled. “I asked her to call my work and let them know I wouldn’t be coming in the next day. Until that happened, I had never missed a day of work since becoming a physician.”

After an anxious night in his jail cell, Dr. Maag lined up with the other inmates the next morning for his bond hearing. His charges included felony, aggravated battery, and felony aggravated assault with a deadly weapon. A prosecutor recommended Dr. Maag’s bond be set at $1 million, which a judge lowered to $500,000.

Michael Fayard, a criminal defense attorney who represented Dr. Maag in the case, said even with the reduction, $500,000 was an outrageous bond for such a case.

“The prosecutor’s arguments to the judge were that he was a physician driving a Tesla,” Mr. Fayard said. “That was his exact argument for charging him a higher bond. It shouldn’t have been that high. I argued he was not a flight risk. He didn’t even have a passport.”

The Florida State Attorney’s Office did not return messages seeking comment about the case.

Dr. Maag spent 2 more nights in jail while he and his wife came up with $50,000 in cash, in accordance with the 10% bond rule. In the meantime, the government put a lien on their house. A circuit court judge later agreed the bond was excessive, according to Mr. Fayard, but by that time, the $50,000 was paid and Dr. Maag was released.
 

New evidence lowers charges 

Dr. Maag ultimately accepted a plea deal from the prosecutor’s office and pled no contest to one count of felony criminal mischief and one count of misdemeanor reckless driving. In return, the state dropped the two more serious felonies. A no-contest plea is not considered an admission of guilt.

Mr. Fayard said his investigation into the road rage victim unearthed evidence that poked holes in the motorcyclist’s credibility, and that contributed to the plea offer.

“We found tons of evidence about the kid being a hot-rodding rider on his motorcycle, videos of him traveling 140 miles an hour, popping wheelies, and darting in and out of traffic,” he said. “There was a lot of mitigation that came up during the course of the investigation.”

The plea deal was a favorable result for Dr. Maag considering his original charges, Mr. Fayard said. He added that the criminal case could have ended much differently.

“Given the facts of this case and given the fact that there were no serious injuries, we supported the state’s decision to accept our mitigation and come out with the sentence that they did,” Mr. Fayard said. “If there would have been injuries, the outcome would have likely been much worse for Dr. Maag.”

With the plea agreement reached, Dr. Maag faced his next consequence – jail time. He was sentenced to 60 days in jail, a $1,000 fine, 12 months of probation, and 8 months of house arrest. Unlike his first jail stay, Dr. Maag said the second, longer stint behind bars was more relaxing. 

“It was the first time since I had become an emergency physician that I remember my dreams,” he recalled. “I had nothing to worry about, nothing to do. All I had to do was get up and eat. Every now and then, I would mop the floors because I’m kind of a clean freak, and I would talk to guys and that was it. It wasn’t bad at all.”

Dr. Maag told no one that he was a doctor because he didn’t want to be treated differently. The anonymity led to interesting tidbits from other inmates about the best pill mills in the area for example, how to make crack cocaine, and selling items for drugs. On his last day in jail, the other inmates learned from his discharge paperwork that Dr. Maag was a physician.

“One of the corrections officers said: ‘You’re a doctor? We’ve never had a doctor in here before!’” Dr. Maag remembers. “He said: ‘What did a doctor do to get into jail?’ I said: ‘Do you really want to know?’ ”

About the time that Dr. Maag was released from jail, the Florida Board of Medicine learned of his charges and began reviewing his case. Mr. Fayard presented the same facts to the board and argued for Dr. Maag to keep his license, emphasizing the offenses in which he was convicted were significantly less severe than the original felonies charged. The board agreed to dismiss the case. 

“The probable cause panel for the board of medicine considered the complaint that has been filed against your client in the above referenced case,” Peter Delia, then-assistant general counsel for the Florida Department of Health, wrote in a letter dated April 27, 2016. “After careful review of all information and evidence obtained in this case, the panel determined that probable cause of a violation does not exist and directed this case to be closed.”
 

A short-lived celebration

Once home, Dr. Maag was on house arrest, but he was granted permission to travel for work. He continued to practice emergency medicine. After several months, authorities dropped the house arrest, and a judge canceled his probation early. It appeared the road rage incident was finally behind him. 

But a year later, in 2018, the doctor received a letter from the Centers for Medicare & Medicaid Services informing him that because of his charges, his Medicare number had been revoked in November 2015.

“It took them 3 years to find me and tell me, even though I never moved,” he said. “Medicare said because I never reported this, they were hitting me up with falsification of documentation because I had signed other Medicare paperwork saying I had never been barred from Medicare, because I didn’t know that I was.”

Dr. Maag hired a different attorney to help him fight the 3-year enrollment ban. He requested reconsideration from CMS, but a hearing officer in October 2017 upheld the revocation. Because his privileges had been revoked in 2015, Dr. Maag’s practice group had to return all money billed by Dr. Maag to Medicare over the 3-year period, which totaled about $190,000.

A CMS spokeswoman declined to comment about Dr. Maag’s case, referring a reporter for this news organization to an administrative law judge’s decision that summarizes the agency’s findings.

According to the summary, in separate reconsidered determinations, the CMS hearing officer concluded that the revocation was proper under section 424.535(a)(3). The regulation, enacted in 2011, allows CMS to revoke billing privileges if a provider was convicted of a federal or state felony within the preceding 10 years that the agency determines is detrimental to the Medicare program and its beneficiaries.

The hearing officer reasoned that Dr. Maag “had been convicted of a felony that is akin to assault and, even if it were not, his actions showed a reckless disregard for the safety of others.” She concluded also that CMS could appropriately revoke Dr. Maag’s Medicare enrollment because he did not report his felony conviction within 30 days as required.

Dr. Maag went through several phases of fighting the revocation, including an appeal to the Department of Health & Human Services Departmental Appeals Board. He argued that his plea was a no-contest plea, which is not considered an admission of guilt. Dr. Maag and his attorney provided CMS a 15-page paper about his background, education, career accomplishments, and patient care history. They emphasized that Dr. Maag had never harmed or threatened a patient, and that his offense had nothing to do with his practice.

In February 2021, Judge Carolyn Cozad Hughes, an administrative law judge with CMS, upheld the 3-year revocation. In her decision, she wrote that for purposes of revocation under CMS law, “convicted” means that a judgment of conviction has been entered by a federal, state, or local court regardless of whether the judgment of conviction has been expunged or otherwise removed. She disagreed with Dr. Maag’s contention that his was a crime against property and, therefore, not akin to any of the felony offenses enumerated under the revocation section, which are crimes against persons.

“Even disregarding the allegations contained in the probable cause affidavit, Petitioner cannot escape the undisputed fact, established by his conviction and his own admissions, that the ‘property’ he so ‘willfully and maliciously’ damaged was a motorcycle traveling at a high rate of speed, and, that two young people were sitting atop that motorcycle,” Judge Hughes wrote. “Moreover, as part of the same conduct, he was charged – and convicted – of misdemeanor reckless driving with ‘willful and wanton disregard for the safety of persons or property.’ Thus, even accepting Petitioner’s description of the events, he unquestionably showed no regard for the safety of the young people on that motorcycle.”

Judge Hughes noted that, although Dr. Maag’s crimes may not be among those specified in the regulation, CMS has broad authority to determine which felonies are detrimental to the best interests of the program and its beneficiaries.
 

A new career path

Unable to practice emergency medicine and beset with debt, Dr. Maag spiraled into a dark depression. His family had to start using retirement money that he was saving for the future care of his son, who has autism.

“I was suicidal,” he said. “There were two times that I came very close to going out to the woods by my house and hanging myself. All I wanted was to have everything go away. My wife saved my life.”

Slowly, Dr. Maag climbed out of the despondency and began considering new career options. After working and training briefly in hair restoration, Dr. Maag became a hair transplant specialist and opened his own hair restoration practice. It was a way to practice and help patients without having to accept Medicare. Today, he is the founder of Honest Hair Restoration in Bradenton, Fla.

Hair restoration is not the type of medicine that he “was designed to do,” Dr. Maag said, but he has embraced its advantages, such as learning about the business aspects of medicine and having a slower-paced work life. The business, which opened in 2019, is doing well and growing steadily.

Earlier this month, Dr. Maag learned CMS had reinstated his Medicare billing privileges. If an opportunity arises to go back into emergency medicine or urgent care, he is open to the possibilities, he said, but he plans to continue hair restoration for now. He hopes the lessons learned from his road rage incident may help others in similar circumstances.

“If I could go back to that very moment, I would’ve just kept my window up and I wouldn’t have said anything,” Dr. Maag said. “I would’ve kept my mouth shut and gone on about my day. Would I have loved it to have never happened? Yeah, and I’d probably be starting my retirement now. Am I stronger now? Well, I’m probably a hell of a lot wiser. But when all is said and done, I don’t want anybody feeling sorry for me. It was all my doing and I have to live with the consequences.”

Mr. Fayard, the attorney, says the case is a cautionary tale for doctors.

“No one is really above the law,” he said. “There aren’t two legal systems. You can’t just pay a little money and be done. At every level, serious charges have serious ramifications for everyone involved. Law enforcement and judges are not going to care of you’re a physician and you commit a crime. But physicians have a lot more on the line than many others. They can lose their ability to practice.”

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

It was a 95° F day in July 2015, and emergency physician Martin Maag, MD, was driving down Bee Ridge Road, a busy seven-lane thoroughfare in Sarasota, Fla., on his way home from a family dinner. To distance himself from a truck blowing black smoke, Dr. Maag says he had just passed some vehicles, when a motorcycle flew past him in the turning lane and the passenger flipped him off.

“I started laughing because I knew we were coming up to a red light,” said Dr. Maag. “When we pulled up to the light, I put my window down and said: ‘Hey, you ought to be a little more careful about who you’re flipping off! You never know who it might be and what they might do.’ ”

The female passenger cursed at Dr. Maag, and the two traded profanities. The male driver then told Dr. Maag: “Get out of the car, old man,” according to Dr. Maag. Fuming, Dr. Maag got out of his black Tesla, and the two men met in the middle of the street.

“As soon as I got close enough to see him, I could tell he really looked young,” Dr. Maag recalls. “I said: ‘You’re like 12 years old. I’m going to end up beating your ass and then I’m going to go to jail. Go get on your bike, and ride home to your mom.’ I don’t remember what he said to me, but I spun around and said: ‘If you want to act like a man, meet me up the street in a parking lot and let’s have at it like men.’ ”

The motorcyclist got back on his white Suzuki and sped off, and Dr. Maag followed. Both vehicles went racing down the road, swerving between cars, and reaching speeds of 100 miles per hour, Dr. Maag said. At one point, Dr. Maag says he drove in front of the motorcyclist to slow him down, and the motorcycle clipped the back of his car. No one was seriously hurt, but soon Dr. Maag was in the back of a police cruiser headed to jail.

Dr. Maag wishes he could take back his actions that summer day 6 years ago. Those few minutes of fury have had lasting effects on the doctor’s life. The incident resulted in criminal charges, a jail sentence, thousands of dollars in legal fees, and a 3-year departure from emergency medicine. Although Dr. Maag did not lose his medical license as a result of the incident, the physician’s Medicare billing privileges were suspended because of a federal provision that ties some felonies to enrollment revocations.

Dr. Maag, 61, shared his story with this news organization to warn other physicians about the wide-ranging career ramifications that can happen as a result of offenses unrelated to medicine. 

“Every doctor, every health professional needs to know that there are a lot of consequences that go with our actions outside of work,” he said. “In my situation, what happened had nothing to do with medicine, it had nothing to do with patients, it had nothing to do my professional demeanor. But yet it affected my entire career, and I lost the ability to practice emergency medicine for 3 years. Three years for any doctor is a long time. Three years for emergency medicine is a lifetime.”
 

The physician ends up in jail

After the collision, Dr. Maag pulled over in a parking lot and dialed 911. Several passing motorists did the same. It appeared the biker was trying to get away, and Dr. Maag was concerned about the damage to his Tesla, he said. 

When police arrived, they heard very different accounts of what happened. The motorcyclist and his girlfriend claimed Dr. Maag was the aggressor during the altercation, and that he deliberately tried to hit them with his vehicle. Two witnesses at the scene said they had watched Dr. Maag pursue the motorcycle in his vehicle, and that they believed he crossed into their lane intentionally to strike the motorcycle, according to police reports.

“[The motorcyclist] stated that the vehicle struck his right foot when it hit the motorcycle and that he was able to keep his balance and not lay the bike down,” Sarasota County Deputy C. Moore wrote in his report. “The motorcycle was damaged on the right side near [his] foot, verifying his story. Both victims were adamant that the defendant actually and intentionally struck the motorcycle with his car due to the previous altercation.”

Dr. Maag told officers the motorcyclist had initiated the confrontation. He acknowledged racing after the biker, but said it was the motorcyclist who hit his vehicle. In an interview, Dr. Maag disputed the witnesses’ accounts, saying that one of the witnesses was without a car and made claims to police that were impossible from her distance. 

In the end, the officer believed the motorcyclist, writing in his report that the damage to the Tesla was consistent with the biker’s version of events. Dr. Maag was handcuffed and taken to the Sarasota County Jail.

“I was in shock,” he said. “When we got to the jail, they got me booked in and fingerprinted. I sat down and said [to an officer]: ‘So, when do I get to bond out?’ The guy started laughing and said: ‘You’re not going anywhere. You’re spending the night in jail, my friend.’ He said: ‘Your charge is one step below murder.’”
 

‘I like to drive fast’

Aside from speeding tickets, Dr. Maag said he had never been in serious trouble with the law before.

The husband and father of two has practiced emergency medicine for more 15 years, and his license has remained in good standing. Florida Department of Health records show Dr. Maag’s medical license as clear and active with no discipline cases or public complaints on file.

“I did my best for every patient that came through that door,” he said. “There were a lot of people who didn’t like my personality. I’ve said many times: ‘I’m not here to be liked. I’m here to take care of people and provide the best care possible.’ ” 

Sarasota County records show that Dr. Maag has received traffic citations in the past for careless driving, unlawful speed, and failure to stop at a red light, among others. He admits to having a “lead foot,” but says he had never before been involved in a road rage incident.

“I’m not going to lie, I like to drive fast,” he said. “I like that feeling. It just seems to slow everything down for me, the faster I’m going.”

After being booked into jail that July evening in 2015, Dr. Maag called his wife to explain what happened.

“She said, ‘I can’t believe you’ve done this. I’ve told you a million times, don’t worry about how other people drive. Keep your mouth shut,’” he recalled. “I asked her to call my work and let them know I wouldn’t be coming in the next day. Until that happened, I had never missed a day of work since becoming a physician.”

After an anxious night in his jail cell, Dr. Maag lined up with the other inmates the next morning for his bond hearing. His charges included felony, aggravated battery, and felony aggravated assault with a deadly weapon. A prosecutor recommended Dr. Maag’s bond be set at $1 million, which a judge lowered to $500,000.

Michael Fayard, a criminal defense attorney who represented Dr. Maag in the case, said even with the reduction, $500,000 was an outrageous bond for such a case.

“The prosecutor’s arguments to the judge were that he was a physician driving a Tesla,” Mr. Fayard said. “That was his exact argument for charging him a higher bond. It shouldn’t have been that high. I argued he was not a flight risk. He didn’t even have a passport.”

The Florida State Attorney’s Office did not return messages seeking comment about the case.

Dr. Maag spent 2 more nights in jail while he and his wife came up with $50,000 in cash, in accordance with the 10% bond rule. In the meantime, the government put a lien on their house. A circuit court judge later agreed the bond was excessive, according to Mr. Fayard, but by that time, the $50,000 was paid and Dr. Maag was released.
 

New evidence lowers charges 

Dr. Maag ultimately accepted a plea deal from the prosecutor’s office and pled no contest to one count of felony criminal mischief and one count of misdemeanor reckless driving. In return, the state dropped the two more serious felonies. A no-contest plea is not considered an admission of guilt.

Mr. Fayard said his investigation into the road rage victim unearthed evidence that poked holes in the motorcyclist’s credibility, and that contributed to the plea offer.

“We found tons of evidence about the kid being a hot-rodding rider on his motorcycle, videos of him traveling 140 miles an hour, popping wheelies, and darting in and out of traffic,” he said. “There was a lot of mitigation that came up during the course of the investigation.”

The plea deal was a favorable result for Dr. Maag considering his original charges, Mr. Fayard said. He added that the criminal case could have ended much differently.

“Given the facts of this case and given the fact that there were no serious injuries, we supported the state’s decision to accept our mitigation and come out with the sentence that they did,” Mr. Fayard said. “If there would have been injuries, the outcome would have likely been much worse for Dr. Maag.”

With the plea agreement reached, Dr. Maag faced his next consequence – jail time. He was sentenced to 60 days in jail, a $1,000 fine, 12 months of probation, and 8 months of house arrest. Unlike his first jail stay, Dr. Maag said the second, longer stint behind bars was more relaxing. 

“It was the first time since I had become an emergency physician that I remember my dreams,” he recalled. “I had nothing to worry about, nothing to do. All I had to do was get up and eat. Every now and then, I would mop the floors because I’m kind of a clean freak, and I would talk to guys and that was it. It wasn’t bad at all.”

Dr. Maag told no one that he was a doctor because he didn’t want to be treated differently. The anonymity led to interesting tidbits from other inmates about the best pill mills in the area for example, how to make crack cocaine, and selling items for drugs. On his last day in jail, the other inmates learned from his discharge paperwork that Dr. Maag was a physician.

“One of the corrections officers said: ‘You’re a doctor? We’ve never had a doctor in here before!’” Dr. Maag remembers. “He said: ‘What did a doctor do to get into jail?’ I said: ‘Do you really want to know?’ ”

About the time that Dr. Maag was released from jail, the Florida Board of Medicine learned of his charges and began reviewing his case. Mr. Fayard presented the same facts to the board and argued for Dr. Maag to keep his license, emphasizing the offenses in which he was convicted were significantly less severe than the original felonies charged. The board agreed to dismiss the case. 

“The probable cause panel for the board of medicine considered the complaint that has been filed against your client in the above referenced case,” Peter Delia, then-assistant general counsel for the Florida Department of Health, wrote in a letter dated April 27, 2016. “After careful review of all information and evidence obtained in this case, the panel determined that probable cause of a violation does not exist and directed this case to be closed.”
 

A short-lived celebration

Once home, Dr. Maag was on house arrest, but he was granted permission to travel for work. He continued to practice emergency medicine. After several months, authorities dropped the house arrest, and a judge canceled his probation early. It appeared the road rage incident was finally behind him. 

But a year later, in 2018, the doctor received a letter from the Centers for Medicare & Medicaid Services informing him that because of his charges, his Medicare number had been revoked in November 2015.

“It took them 3 years to find me and tell me, even though I never moved,” he said. “Medicare said because I never reported this, they were hitting me up with falsification of documentation because I had signed other Medicare paperwork saying I had never been barred from Medicare, because I didn’t know that I was.”

Dr. Maag hired a different attorney to help him fight the 3-year enrollment ban. He requested reconsideration from CMS, but a hearing officer in October 2017 upheld the revocation. Because his privileges had been revoked in 2015, Dr. Maag’s practice group had to return all money billed by Dr. Maag to Medicare over the 3-year period, which totaled about $190,000.

A CMS spokeswoman declined to comment about Dr. Maag’s case, referring a reporter for this news organization to an administrative law judge’s decision that summarizes the agency’s findings.

According to the summary, in separate reconsidered determinations, the CMS hearing officer concluded that the revocation was proper under section 424.535(a)(3). The regulation, enacted in 2011, allows CMS to revoke billing privileges if a provider was convicted of a federal or state felony within the preceding 10 years that the agency determines is detrimental to the Medicare program and its beneficiaries.

The hearing officer reasoned that Dr. Maag “had been convicted of a felony that is akin to assault and, even if it were not, his actions showed a reckless disregard for the safety of others.” She concluded also that CMS could appropriately revoke Dr. Maag’s Medicare enrollment because he did not report his felony conviction within 30 days as required.

Dr. Maag went through several phases of fighting the revocation, including an appeal to the Department of Health & Human Services Departmental Appeals Board. He argued that his plea was a no-contest plea, which is not considered an admission of guilt. Dr. Maag and his attorney provided CMS a 15-page paper about his background, education, career accomplishments, and patient care history. They emphasized that Dr. Maag had never harmed or threatened a patient, and that his offense had nothing to do with his practice.

In February 2021, Judge Carolyn Cozad Hughes, an administrative law judge with CMS, upheld the 3-year revocation. In her decision, she wrote that for purposes of revocation under CMS law, “convicted” means that a judgment of conviction has been entered by a federal, state, or local court regardless of whether the judgment of conviction has been expunged or otherwise removed. She disagreed with Dr. Maag’s contention that his was a crime against property and, therefore, not akin to any of the felony offenses enumerated under the revocation section, which are crimes against persons.

“Even disregarding the allegations contained in the probable cause affidavit, Petitioner cannot escape the undisputed fact, established by his conviction and his own admissions, that the ‘property’ he so ‘willfully and maliciously’ damaged was a motorcycle traveling at a high rate of speed, and, that two young people were sitting atop that motorcycle,” Judge Hughes wrote. “Moreover, as part of the same conduct, he was charged – and convicted – of misdemeanor reckless driving with ‘willful and wanton disregard for the safety of persons or property.’ Thus, even accepting Petitioner’s description of the events, he unquestionably showed no regard for the safety of the young people on that motorcycle.”

Judge Hughes noted that, although Dr. Maag’s crimes may not be among those specified in the regulation, CMS has broad authority to determine which felonies are detrimental to the best interests of the program and its beneficiaries.
 

A new career path

Unable to practice emergency medicine and beset with debt, Dr. Maag spiraled into a dark depression. His family had to start using retirement money that he was saving for the future care of his son, who has autism.

“I was suicidal,” he said. “There were two times that I came very close to going out to the woods by my house and hanging myself. All I wanted was to have everything go away. My wife saved my life.”

Slowly, Dr. Maag climbed out of the despondency and began considering new career options. After working and training briefly in hair restoration, Dr. Maag became a hair transplant specialist and opened his own hair restoration practice. It was a way to practice and help patients without having to accept Medicare. Today, he is the founder of Honest Hair Restoration in Bradenton, Fla.

Hair restoration is not the type of medicine that he “was designed to do,” Dr. Maag said, but he has embraced its advantages, such as learning about the business aspects of medicine and having a slower-paced work life. The business, which opened in 2019, is doing well and growing steadily.

Earlier this month, Dr. Maag learned CMS had reinstated his Medicare billing privileges. If an opportunity arises to go back into emergency medicine or urgent care, he is open to the possibilities, he said, but he plans to continue hair restoration for now. He hopes the lessons learned from his road rage incident may help others in similar circumstances.

“If I could go back to that very moment, I would’ve just kept my window up and I wouldn’t have said anything,” Dr. Maag said. “I would’ve kept my mouth shut and gone on about my day. Would I have loved it to have never happened? Yeah, and I’d probably be starting my retirement now. Am I stronger now? Well, I’m probably a hell of a lot wiser. But when all is said and done, I don’t want anybody feeling sorry for me. It was all my doing and I have to live with the consequences.”

Mr. Fayard, the attorney, says the case is a cautionary tale for doctors.

“No one is really above the law,” he said. “There aren’t two legal systems. You can’t just pay a little money and be done. At every level, serious charges have serious ramifications for everyone involved. Law enforcement and judges are not going to care of you’re a physician and you commit a crime. But physicians have a lot more on the line than many others. They can lose their ability to practice.”

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

The U.S. Food and Drug Administration has provided a detailed and documented account of how it arrived at its decision to approve the controversial Alzheimer’s drug aducanumab (Aduhelm, Biogen/Eisai), including the release of several internal documents.

In a letter sent to members of the FDA’s Center for Drug Evaluation Research (CDER), CDER Director Patrizia Cavazzoni, MD, noted that in view of the “fierce public debate” that erupted immediately following the drug’s approval, she felt compelled to explain how the agency came to its decision.

Also publicly released today on the FDA’s updated aducanumab landing page was “the first set of review memos,” for the drug.

“We’re releasing these documents with the intent of informing public discourse – providing interested parties with the opportunity to explore the data that helped shape our decision to grant accelerated approval,” Dr. Cavazzoni wrote. “The rest of the approval package will be released over the next several days,” she added.
 

Immediate backlash

The FDA’s June 7 approval of aducanumab was met with instant backlash. In November 2020, the agency’s Peripheral and Central Nervous System Drugs Advisory Committee voted nearly unanimously to not vote in favor of approval because of a lack of evidence proving its efficacy.

Since the drug was approved, three of the advisory committee’s members resigned in protest. In addition, the high-profile consumer advocacy group Public Citizen sent a letter to the secretary of the U.S. Department of Health & Human Services demanding the removal of three FDA officials, including acting FDA Commissioner Janet Woodcock, MD.

In its letter, the group noted that the FDA’s decision “showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.”

Even the Alzheimer’s Association, which was a staunch supporter of the drug throughout its development process and applauded its approval, expressed outrage over its more than $56,000-a-year cost to patients and called the price “simply unacceptable” in a statement.

In the June 23 letter, the CDER director noted, “this was one of the most complex applications in recent history” and admitted that deliberations were lengthy and difficult.

“It’s also not surprising, in fact it was to be expected, that there would be different viewpoints about the data, including dissenting opinions about the approval decision,” Dr. Cavazzoni wrote.

However, this “is what scientific debate is all about, and while difficult at times, it should be celebrated,” she added. “Please know that every opinion was heard, and the approval is a direct reflection of this open and robust scientific and regulatory debate.”
 

Accelerated approval pathway

Documents newly posted to the FDA’s aducanumab landing page include CDER’s Office of Neurology’s Summary Review Memorandum, which includes details on the basis for the approval; the Concurrence Memorandum from the director of CDER’s Office of New Drugs; and the Concurrence Memorandum from Dr. Cavazzoni.

“The remaining scientific review documents in the Aduhelm action package are not yet available but will be made available to the public as soon as the internal process of review and redaction is complete,” the FDA noted on its site.

In the document FDA’s Decision to Approve New Treatment for Alzheimer’s Disease, Dr. Cavazzoni noted that the “highly complex” data included in the submission package for the drug “left residual uncertainties regarding clinical benefit.”

However, after listening to the patient community and reviewing all the data, the FDA chose to use the Accelerated Approval pathway, deciding that the potential benefit to patients outweighed the drug’s risks.

Of two phase 3 trials, only one met its primary endpoint. However, in all trials, including earlier studies, “Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion,” Dr. Cavazzoni wrote.

“It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline,” she added.

Dr. Cavazzoni noted that although the Advisory Committee did not agree that clinical benefit from one trial meeting its primary endpoint was enough for approval, “the option of Accelerated Approval was not discussed” at that time.

This type of approval “is based on a surrogate or intermediate clinical endpoint, in this case reduction of amyloid plaque in the brain” and requires post-approval studies to verify clinical benefit.

Dr. Cavazzoni added that the drug could still be removed from the market if its confirmatory trial does not verify this type of benefit.

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

The U.S. Food and Drug Administration has provided a detailed and documented account of how it arrived at its decision to approve the controversial Alzheimer’s drug aducanumab (Aduhelm, Biogen/Eisai), including the release of several internal documents.

In a letter sent to members of the FDA’s Center for Drug Evaluation Research (CDER), CDER Director Patrizia Cavazzoni, MD, noted that in view of the “fierce public debate” that erupted immediately following the drug’s approval, she felt compelled to explain how the agency came to its decision.

Also publicly released today on the FDA’s updated aducanumab landing page was “the first set of review memos,” for the drug.

“We’re releasing these documents with the intent of informing public discourse – providing interested parties with the opportunity to explore the data that helped shape our decision to grant accelerated approval,” Dr. Cavazzoni wrote. “The rest of the approval package will be released over the next several days,” she added.
 

Immediate backlash

The FDA’s June 7 approval of aducanumab was met with instant backlash. In November 2020, the agency’s Peripheral and Central Nervous System Drugs Advisory Committee voted nearly unanimously to not vote in favor of approval because of a lack of evidence proving its efficacy.

Since the drug was approved, three of the advisory committee’s members resigned in protest. In addition, the high-profile consumer advocacy group Public Citizen sent a letter to the secretary of the U.S. Department of Health & Human Services demanding the removal of three FDA officials, including acting FDA Commissioner Janet Woodcock, MD.

In its letter, the group noted that the FDA’s decision “showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.”

Even the Alzheimer’s Association, which was a staunch supporter of the drug throughout its development process and applauded its approval, expressed outrage over its more than $56,000-a-year cost to patients and called the price “simply unacceptable” in a statement.

In the June 23 letter, the CDER director noted, “this was one of the most complex applications in recent history” and admitted that deliberations were lengthy and difficult.

“It’s also not surprising, in fact it was to be expected, that there would be different viewpoints about the data, including dissenting opinions about the approval decision,” Dr. Cavazzoni wrote.

However, this “is what scientific debate is all about, and while difficult at times, it should be celebrated,” she added. “Please know that every opinion was heard, and the approval is a direct reflection of this open and robust scientific and regulatory debate.”
 

Accelerated approval pathway

Documents newly posted to the FDA’s aducanumab landing page include CDER’s Office of Neurology’s Summary Review Memorandum, which includes details on the basis for the approval; the Concurrence Memorandum from the director of CDER’s Office of New Drugs; and the Concurrence Memorandum from Dr. Cavazzoni.

“The remaining scientific review documents in the Aduhelm action package are not yet available but will be made available to the public as soon as the internal process of review and redaction is complete,” the FDA noted on its site.

In the document FDA’s Decision to Approve New Treatment for Alzheimer’s Disease, Dr. Cavazzoni noted that the “highly complex” data included in the submission package for the drug “left residual uncertainties regarding clinical benefit.”

However, after listening to the patient community and reviewing all the data, the FDA chose to use the Accelerated Approval pathway, deciding that the potential benefit to patients outweighed the drug’s risks.

Of two phase 3 trials, only one met its primary endpoint. However, in all trials, including earlier studies, “Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion,” Dr. Cavazzoni wrote.

“It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline,” she added.

Dr. Cavazzoni noted that although the Advisory Committee did not agree that clinical benefit from one trial meeting its primary endpoint was enough for approval, “the option of Accelerated Approval was not discussed” at that time.

This type of approval “is based on a surrogate or intermediate clinical endpoint, in this case reduction of amyloid plaque in the brain” and requires post-approval studies to verify clinical benefit.

Dr. Cavazzoni added that the drug could still be removed from the market if its confirmatory trial does not verify this type of benefit.

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

The U.S. Food and Drug Administration has provided a detailed and documented account of how it arrived at its decision to approve the controversial Alzheimer’s drug aducanumab (Aduhelm, Biogen/Eisai), including the release of several internal documents.

In a letter sent to members of the FDA’s Center for Drug Evaluation Research (CDER), CDER Director Patrizia Cavazzoni, MD, noted that in view of the “fierce public debate” that erupted immediately following the drug’s approval, she felt compelled to explain how the agency came to its decision.

Also publicly released today on the FDA’s updated aducanumab landing page was “the first set of review memos,” for the drug.

“We’re releasing these documents with the intent of informing public discourse – providing interested parties with the opportunity to explore the data that helped shape our decision to grant accelerated approval,” Dr. Cavazzoni wrote. “The rest of the approval package will be released over the next several days,” she added.
 

Immediate backlash

The FDA’s June 7 approval of aducanumab was met with instant backlash. In November 2020, the agency’s Peripheral and Central Nervous System Drugs Advisory Committee voted nearly unanimously to not vote in favor of approval because of a lack of evidence proving its efficacy.

Since the drug was approved, three of the advisory committee’s members resigned in protest. In addition, the high-profile consumer advocacy group Public Citizen sent a letter to the secretary of the U.S. Department of Health & Human Services demanding the removal of three FDA officials, including acting FDA Commissioner Janet Woodcock, MD.

In its letter, the group noted that the FDA’s decision “showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.”

Even the Alzheimer’s Association, which was a staunch supporter of the drug throughout its development process and applauded its approval, expressed outrage over its more than $56,000-a-year cost to patients and called the price “simply unacceptable” in a statement.

In the June 23 letter, the CDER director noted, “this was one of the most complex applications in recent history” and admitted that deliberations were lengthy and difficult.

“It’s also not surprising, in fact it was to be expected, that there would be different viewpoints about the data, including dissenting opinions about the approval decision,” Dr. Cavazzoni wrote.

However, this “is what scientific debate is all about, and while difficult at times, it should be celebrated,” she added. “Please know that every opinion was heard, and the approval is a direct reflection of this open and robust scientific and regulatory debate.”
 

Accelerated approval pathway

Documents newly posted to the FDA’s aducanumab landing page include CDER’s Office of Neurology’s Summary Review Memorandum, which includes details on the basis for the approval; the Concurrence Memorandum from the director of CDER’s Office of New Drugs; and the Concurrence Memorandum from Dr. Cavazzoni.

“The remaining scientific review documents in the Aduhelm action package are not yet available but will be made available to the public as soon as the internal process of review and redaction is complete,” the FDA noted on its site.

In the document FDA’s Decision to Approve New Treatment for Alzheimer’s Disease, Dr. Cavazzoni noted that the “highly complex” data included in the submission package for the drug “left residual uncertainties regarding clinical benefit.”

However, after listening to the patient community and reviewing all the data, the FDA chose to use the Accelerated Approval pathway, deciding that the potential benefit to patients outweighed the drug’s risks.

Of two phase 3 trials, only one met its primary endpoint. However, in all trials, including earlier studies, “Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion,” Dr. Cavazzoni wrote.

“It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline,” she added.

Dr. Cavazzoni noted that although the Advisory Committee did not agree that clinical benefit from one trial meeting its primary endpoint was enough for approval, “the option of Accelerated Approval was not discussed” at that time.

This type of approval “is based on a surrogate or intermediate clinical endpoint, in this case reduction of amyloid plaque in the brain” and requires post-approval studies to verify clinical benefit.

Dr. Cavazzoni added that the drug could still be removed from the market if its confirmatory trial does not verify this type of benefit.

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