Clinical Psychiatry News

Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at [email protected].

Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at [email protected].

Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at [email protected].

To say that the pandemic has dropped us into uncharted territory is an understatement of unmeasurable proportions. Every day we learn more about it, and every day that new information brings us new challenges. COVID-19 is playing by its own set of rules. To keep pace with it societies have been forced to adapt to them, and members of those societies have had to realize that these new rules must be obeyed or be prepared to suffer the consequences.

BananaStock/Thinkstock

I’m not sure exactly when it happened but gradually over my 7 and a half decades on this planet it appears that following the rules and understanding the value of “No” have become concepts to be ignored and left to gather dust in the attics and basements of our society. The tug of war between well-considered rules and the often misinterpreted concept of freedom has been ebbing and flowing since Eve plucked a forbidden apple off that tree.

In some parts of the world, the twin skills of saying and responding to “No” have become lost arts. I think it is not by chance that, of the four books I have written for parents, the one titled “How to Say No to Your Toddler” has become the most widely distributed, having been translated into Italian, Polish, and Russian. It is only slightly comforting to learn that at least some parents understand that creating rules can be important, but realize they aren’t quite sure how go about it.

As it has become clear that social distancing and mask wearing are associated with curtailing the spread of COVID-19, state and local governments have had to bone up on their long-forgotten No-saying skills. This relearning process has been particularly painful for school administrators who may have been warned that “You’ll never be able to get first and second graders to wear masks” or that “College students just won’t obey the rules.”

Both of these cautions are based on observations by educators with years of experience and certainly have a ring of truth to them. But could it be that these pessimistic predictions reflect a society in which parents and educators have lost the talent for crafting sensible rules and linking them to enforceable and rational consequences?

As colleges throughout the country have reopened using a variety of learning and residential strategies, there have been numerous incidents that validate the gloomy predictions of student misbehavior. Smaller schools seem to be having less difficulty, which is not surprising given their relative ease in fostering a sense of community. Many schools have been forced to rollback their plans for in-person learning because students have failed to follow some very simple but unpopular rules.

In a swift and decisive response to student misbehavior, Northeastern University in Boston dismissed 11 first-year students and will not refund their tuition when officials discovered a prohibited social gathering in one of the resident facilities (“Northeastern Dismisses 11 Students for Gathering in Violation of COVID-19 Policies,” by Ian Thomsen, News at Northwestern). This response seemed to have come as a surprise to many students and parents around the country who have become accustomed a diet of warnings and minor sanctions.

Whether this action by Northeastern will trigger similar responses by other universities remains to be seen. But we can hope that it sets an example of how learning about “No” can be an important part of one’s education.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

To say that the pandemic has dropped us into uncharted territory is an understatement of unmeasurable proportions. Every day we learn more about it, and every day that new information brings us new challenges. COVID-19 is playing by its own set of rules. To keep pace with it societies have been forced to adapt to them, and members of those societies have had to realize that these new rules must be obeyed or be prepared to suffer the consequences.

BananaStock/Thinkstock

I’m not sure exactly when it happened but gradually over my 7 and a half decades on this planet it appears that following the rules and understanding the value of “No” have become concepts to be ignored and left to gather dust in the attics and basements of our society. The tug of war between well-considered rules and the often misinterpreted concept of freedom has been ebbing and flowing since Eve plucked a forbidden apple off that tree.

In some parts of the world, the twin skills of saying and responding to “No” have become lost arts. I think it is not by chance that, of the four books I have written for parents, the one titled “How to Say No to Your Toddler” has become the most widely distributed, having been translated into Italian, Polish, and Russian. It is only slightly comforting to learn that at least some parents understand that creating rules can be important, but realize they aren’t quite sure how go about it.

As it has become clear that social distancing and mask wearing are associated with curtailing the spread of COVID-19, state and local governments have had to bone up on their long-forgotten No-saying skills. This relearning process has been particularly painful for school administrators who may have been warned that “You’ll never be able to get first and second graders to wear masks” or that “College students just won’t obey the rules.”

Both of these cautions are based on observations by educators with years of experience and certainly have a ring of truth to them. But could it be that these pessimistic predictions reflect a society in which parents and educators have lost the talent for crafting sensible rules and linking them to enforceable and rational consequences?

As colleges throughout the country have reopened using a variety of learning and residential strategies, there have been numerous incidents that validate the gloomy predictions of student misbehavior. Smaller schools seem to be having less difficulty, which is not surprising given their relative ease in fostering a sense of community. Many schools have been forced to rollback their plans for in-person learning because students have failed to follow some very simple but unpopular rules.

In a swift and decisive response to student misbehavior, Northeastern University in Boston dismissed 11 first-year students and will not refund their tuition when officials discovered a prohibited social gathering in one of the resident facilities (“Northeastern Dismisses 11 Students for Gathering in Violation of COVID-19 Policies,” by Ian Thomsen, News at Northwestern). This response seemed to have come as a surprise to many students and parents around the country who have become accustomed a diet of warnings and minor sanctions.

Whether this action by Northeastern will trigger similar responses by other universities remains to be seen. But we can hope that it sets an example of how learning about “No” can be an important part of one’s education.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

To say that the pandemic has dropped us into uncharted territory is an understatement of unmeasurable proportions. Every day we learn more about it, and every day that new information brings us new challenges. COVID-19 is playing by its own set of rules. To keep pace with it societies have been forced to adapt to them, and members of those societies have had to realize that these new rules must be obeyed or be prepared to suffer the consequences.

BananaStock/Thinkstock

I’m not sure exactly when it happened but gradually over my 7 and a half decades on this planet it appears that following the rules and understanding the value of “No” have become concepts to be ignored and left to gather dust in the attics and basements of our society. The tug of war between well-considered rules and the often misinterpreted concept of freedom has been ebbing and flowing since Eve plucked a forbidden apple off that tree.

In some parts of the world, the twin skills of saying and responding to “No” have become lost arts. I think it is not by chance that, of the four books I have written for parents, the one titled “How to Say No to Your Toddler” has become the most widely distributed, having been translated into Italian, Polish, and Russian. It is only slightly comforting to learn that at least some parents understand that creating rules can be important, but realize they aren’t quite sure how go about it.

As it has become clear that social distancing and mask wearing are associated with curtailing the spread of COVID-19, state and local governments have had to bone up on their long-forgotten No-saying skills. This relearning process has been particularly painful for school administrators who may have been warned that “You’ll never be able to get first and second graders to wear masks” or that “College students just won’t obey the rules.”

Both of these cautions are based on observations by educators with years of experience and certainly have a ring of truth to them. But could it be that these pessimistic predictions reflect a society in which parents and educators have lost the talent for crafting sensible rules and linking them to enforceable and rational consequences?

As colleges throughout the country have reopened using a variety of learning and residential strategies, there have been numerous incidents that validate the gloomy predictions of student misbehavior. Smaller schools seem to be having less difficulty, which is not surprising given their relative ease in fostering a sense of community. Many schools have been forced to rollback their plans for in-person learning because students have failed to follow some very simple but unpopular rules.

In a swift and decisive response to student misbehavior, Northeastern University in Boston dismissed 11 first-year students and will not refund their tuition when officials discovered a prohibited social gathering in one of the resident facilities (“Northeastern Dismisses 11 Students for Gathering in Violation of COVID-19 Policies,” by Ian Thomsen, News at Northwestern). This response seemed to have come as a surprise to many students and parents around the country who have become accustomed a diet of warnings and minor sanctions.

Whether this action by Northeastern will trigger similar responses by other universities remains to be seen. But we can hope that it sets an example of how learning about “No” can be an important part of one’s education.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Cardiovascular health should be routinely assessed and addressed in LGBTQ adults, the American Heart Association concluded in a new scientific statement.

“Among the most important takeaways from this scientific statement is the need for health care providers in clinical settings to routinely assess sexual orientation and gender identity,” Billy A. Caceres, PhD, RN, chair of the statement writing group, said in an interview.

“This will help health care providers engage LGBTQ patients in discussions about their heart health that account for the unique experiences of this population,” said Dr. Caceres, assistant professor at Columbia University, New York.

The statement was published online Oct. 8 in Circulation.
 

‘Invisible’ population

There are roughly 11 million LGBTQ adults in the United States, yet they are often “invisible in health care settings and cardiovascular research,” Dr. Caceres noted. The AHA scientific statement is the first from a national organization in the United States to comprehensively summarize the evidence on cardiovascular (CV) research in LGBTQ adults.

There is mounting evidence that LGBTQ adults experience worse CV health relative to their cisgender heterosexual peers. Disparities in CV health may be driven by unique psychosocial stressors in the LGBTQ individuals such as family rejection and anxiety of concealment of their sexual orientation or gender identity.

While there is limited information on the CV health of LGBTQ people, the writing group said providers should be aware of the following:

• LGBTQ adults are more likely to use tobacco than their cisgender heterosexual peers.
• Transgender adults may be less physically active than their cisgender counterparts. Gender-affirming care might play a role in promoting physical activity among transgender people.
• Transgender women may be at increased risk for heart disease because of behavioral and clinical factors (such as the use of gender-affirming hormones like estrogen).
• Transgender women and nonbinary persons are more likely to binge drink.
• Lesbian and bisexual women have a higher prevalence of obesity than heterosexual women do.

“We need to better understand how to support LGBTQ adults in optimizing their CV health. To do this, we will need rigorous research that examines potential explanations for the CV health disparities that have been observed in LGBTQ adults,” Dr. Caceres said.

He noted that research is also needed within the LGBTQ population among groups that might be at greater risk for heart disease, including racial- and ethnic-minority and low-income LGBTQ adults.

“Researchers should also design and test evidence-based interventions to promote the heart health of LGBTQ adults. This is an area that is greatly lacking within CV health research,” said Dr. Caceres.
 

Discrimination in health care

Discrimination against LGBTQ adults in health care settings also remains a problem, the authors noted.

The writing group cites data showing that nearly 56% of sexual-minority and 70% of gender-minority adults report having experienced some form of discrimination from clinicians, including the use of harsh/abusive language.

“Perhaps most alarming,” roughly 8% of sexual-minority and 25% of transgender individuals have been denied health care by clinicians, they noted.

“LGBTQ individuals are delaying primary care and preventative visits because there is a great fear of being treated differently. Being treated differently often means receiving inadequate or inferior care because of sexual orientation or gender identity,” Dr. Caceres said in a news release.

The writing group calls for greater emphasis on LGBTQ health issues in the education of all health care providers. Dr. Caceres said it’s “paramount to include content about LGBTQ health in clinical training and licensure requirements in order to address these cardiovascular health disparities.”

Traditionally, there has been very little LGBTQ-related content in health care professional education training. A 2018 online survey of students at 10 medical schools found that approximately 80% of students did not feel competent to provide care for transgender patients.

But that may soon change. In September 2020, the Accreditation Review Commission on Education for the Physician Assistant began requiring LGBTQ curricular content, the writing group notes.

The AHA scientific statement on LGBTQ was developed by the writing group on behalf of the AHA Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.

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

Cardiovascular health should be routinely assessed and addressed in LGBTQ adults, the American Heart Association concluded in a new scientific statement.

“Among the most important takeaways from this scientific statement is the need for health care providers in clinical settings to routinely assess sexual orientation and gender identity,” Billy A. Caceres, PhD, RN, chair of the statement writing group, said in an interview.

“This will help health care providers engage LGBTQ patients in discussions about their heart health that account for the unique experiences of this population,” said Dr. Caceres, assistant professor at Columbia University, New York.

The statement was published online Oct. 8 in Circulation.
 

‘Invisible’ population

There are roughly 11 million LGBTQ adults in the United States, yet they are often “invisible in health care settings and cardiovascular research,” Dr. Caceres noted. The AHA scientific statement is the first from a national organization in the United States to comprehensively summarize the evidence on cardiovascular (CV) research in LGBTQ adults.

There is mounting evidence that LGBTQ adults experience worse CV health relative to their cisgender heterosexual peers. Disparities in CV health may be driven by unique psychosocial stressors in the LGBTQ individuals such as family rejection and anxiety of concealment of their sexual orientation or gender identity.

While there is limited information on the CV health of LGBTQ people, the writing group said providers should be aware of the following:

• LGBTQ adults are more likely to use tobacco than their cisgender heterosexual peers.
• Transgender adults may be less physically active than their cisgender counterparts. Gender-affirming care might play a role in promoting physical activity among transgender people.
• Transgender women may be at increased risk for heart disease because of behavioral and clinical factors (such as the use of gender-affirming hormones like estrogen).
• Transgender women and nonbinary persons are more likely to binge drink.
• Lesbian and bisexual women have a higher prevalence of obesity than heterosexual women do.

“We need to better understand how to support LGBTQ adults in optimizing their CV health. To do this, we will need rigorous research that examines potential explanations for the CV health disparities that have been observed in LGBTQ adults,” Dr. Caceres said.

He noted that research is also needed within the LGBTQ population among groups that might be at greater risk for heart disease, including racial- and ethnic-minority and low-income LGBTQ adults.

“Researchers should also design and test evidence-based interventions to promote the heart health of LGBTQ adults. This is an area that is greatly lacking within CV health research,” said Dr. Caceres.
 

Discrimination in health care

Discrimination against LGBTQ adults in health care settings also remains a problem, the authors noted.

The writing group cites data showing that nearly 56% of sexual-minority and 70% of gender-minority adults report having experienced some form of discrimination from clinicians, including the use of harsh/abusive language.

“Perhaps most alarming,” roughly 8% of sexual-minority and 25% of transgender individuals have been denied health care by clinicians, they noted.

“LGBTQ individuals are delaying primary care and preventative visits because there is a great fear of being treated differently. Being treated differently often means receiving inadequate or inferior care because of sexual orientation or gender identity,” Dr. Caceres said in a news release.

The writing group calls for greater emphasis on LGBTQ health issues in the education of all health care providers. Dr. Caceres said it’s “paramount to include content about LGBTQ health in clinical training and licensure requirements in order to address these cardiovascular health disparities.”

Traditionally, there has been very little LGBTQ-related content in health care professional education training. A 2018 online survey of students at 10 medical schools found that approximately 80% of students did not feel competent to provide care for transgender patients.

But that may soon change. In September 2020, the Accreditation Review Commission on Education for the Physician Assistant began requiring LGBTQ curricular content, the writing group notes.

The AHA scientific statement on LGBTQ was developed by the writing group on behalf of the AHA Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.

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

Cardiovascular health should be routinely assessed and addressed in LGBTQ adults, the American Heart Association concluded in a new scientific statement.

“Among the most important takeaways from this scientific statement is the need for health care providers in clinical settings to routinely assess sexual orientation and gender identity,” Billy A. Caceres, PhD, RN, chair of the statement writing group, said in an interview.

“This will help health care providers engage LGBTQ patients in discussions about their heart health that account for the unique experiences of this population,” said Dr. Caceres, assistant professor at Columbia University, New York.

The statement was published online Oct. 8 in Circulation.
 

‘Invisible’ population

There are roughly 11 million LGBTQ adults in the United States, yet they are often “invisible in health care settings and cardiovascular research,” Dr. Caceres noted. The AHA scientific statement is the first from a national organization in the United States to comprehensively summarize the evidence on cardiovascular (CV) research in LGBTQ adults.

There is mounting evidence that LGBTQ adults experience worse CV health relative to their cisgender heterosexual peers. Disparities in CV health may be driven by unique psychosocial stressors in the LGBTQ individuals such as family rejection and anxiety of concealment of their sexual orientation or gender identity.

While there is limited information on the CV health of LGBTQ people, the writing group said providers should be aware of the following:

• LGBTQ adults are more likely to use tobacco than their cisgender heterosexual peers.
• Transgender adults may be less physically active than their cisgender counterparts. Gender-affirming care might play a role in promoting physical activity among transgender people.
• Transgender women may be at increased risk for heart disease because of behavioral and clinical factors (such as the use of gender-affirming hormones like estrogen).
• Transgender women and nonbinary persons are more likely to binge drink.
• Lesbian and bisexual women have a higher prevalence of obesity than heterosexual women do.

“We need to better understand how to support LGBTQ adults in optimizing their CV health. To do this, we will need rigorous research that examines potential explanations for the CV health disparities that have been observed in LGBTQ adults,” Dr. Caceres said.

He noted that research is also needed within the LGBTQ population among groups that might be at greater risk for heart disease, including racial- and ethnic-minority and low-income LGBTQ adults.

“Researchers should also design and test evidence-based interventions to promote the heart health of LGBTQ adults. This is an area that is greatly lacking within CV health research,” said Dr. Caceres.
 

Discrimination in health care

Discrimination against LGBTQ adults in health care settings also remains a problem, the authors noted.

The writing group cites data showing that nearly 56% of sexual-minority and 70% of gender-minority adults report having experienced some form of discrimination from clinicians, including the use of harsh/abusive language.

“Perhaps most alarming,” roughly 8% of sexual-minority and 25% of transgender individuals have been denied health care by clinicians, they noted.

“LGBTQ individuals are delaying primary care and preventative visits because there is a great fear of being treated differently. Being treated differently often means receiving inadequate or inferior care because of sexual orientation or gender identity,” Dr. Caceres said in a news release.

The writing group calls for greater emphasis on LGBTQ health issues in the education of all health care providers. Dr. Caceres said it’s “paramount to include content about LGBTQ health in clinical training and licensure requirements in order to address these cardiovascular health disparities.”

Traditionally, there has been very little LGBTQ-related content in health care professional education training. A 2018 online survey of students at 10 medical schools found that approximately 80% of students did not feel competent to provide care for transgender patients.

But that may soon change. In September 2020, the Accreditation Review Commission on Education for the Physician Assistant began requiring LGBTQ curricular content, the writing group notes.

The AHA scientific statement on LGBTQ was developed by the writing group on behalf of the AHA Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.

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

One of the hottest topics now in psychiatry is the possibility of repurposing long-established cardiovascular medications for treatment of patients with serious mental illness, Livia De Picker, MD, PhD, said at the virtual congress of the European College of Neuropsychopharmacology.

Courtesy Dr. Livia De Picker

The appeal is multifold. A huge unmet need exists in psychiatry for new and better treatments with novel mechanisms of action. Many guideline-recommended cardiovascular medications have a long track record, including a well-established safety profile with no surprises, and are available in generic versions. They can be developed for a new indication at minimal cost, noted Dr. De Picker, a psychiatrist at the University of Antwerp (Belgium).

The idea of psychiatric repurposing of drugs originally developed for nonpsychiatric indications is nothing new, she added. Examples include lithium for gout, valproate for epilepsy, and ketamine for anesthesiology.

One hitch in efforts to repurpose cardiovascular medications is that, when psychiatric patients have been included in randomized trials of the drugs’ cardiovascular effects, the psychiatric outcomes often went untallied.

Indeed, the only high-quality randomized trial evidence of psychiatric benefits for any class of cardiovascular medications is for statins, where a modest-sized meta-analysis of six placebo-controlled trials in 339 patients with schizophrenia showed the lipid-lowering agents had benefit for both positive and negative symptoms (Psychiatry Res. 2018 Apr;262:84-93). But that’s not a body of data of sufficient size to be definitive, in Dr. De Picker’s view.

Much of the recent enthusiasm for exploring the potential of cardiovascular drugs for psychiatric conditions comes from hypothesis-generating big data analyses drawn from Scandinavian national patient registries. Danish investigators scrutinized all 1.6 million Danes exposed to six classes of drugs of interest during 2005-2015 and determined that those on long-term statins, low-dose aspirin, ACE inhibitors, angiotensin receptor blockers, or allopurinol were associated with a decreased rate of new-onset depression, while high-dose aspirin and non-aspirin NSAIDs were associated with an increased rate, compared with a 30% random sample of the country’s population (Acta Psychiatr Scand. 2019 Jan;1391:68-77).

Similarly, the Danish group found that continued use of statins, angiotensin agents, or low-dose aspirin was associated with a decreased rate of new-onset bipolar disorder, while high-dose aspirin and other NSAIDs were linked to increased risk (Bipolar Disord. 2019 Aug;[15]:410-8). What these agents have in common, the investigators observed, is that they act on inflammation and potentially on the stress response system.

Meanwhile, Swedish investigators examined the course of 142,691 Swedes with a diagnosis of bipolar disorder, schizophrenia, or nonaffective psychosis during 2005-2016. They determined that, during periods when those individuals were on a statin, calcium channel blocker, or metformin, they had reduced rates of psychiatric hospitalization and self-harm (JAMA Psychiatry. 2019 Apr 1;76[4]:382-90).

Scottish researchers analyzed the health records of 144,066 patients placed on monotherapy for hypertension and determined that the lowest risk for hospitalization for a mood disorder during follow-up was in those prescribed an ACE inhibitor or angiotensin receptor blocker. The risk was significantly higher in patients on a beta-blocker or calcium channel blocker, and intermediate in those on a thiazide diuretic (Hypertension. 2016 Nov;68[5:1132-8).

“Obviously, this is all at a very macro scale and we have no idea whatsoever what this means for individual patients, number needed to treat, or which type of patients would benefit, but it does provide us with some guidance for future research,” according to Dr. De Picker.

In the meantime, while physicians await definitive evidence of any impact of cardiovascular drugs might have on psychiatric outcomes, abundant data exist underscoring what she called “shockingly high levels” of inadequate management of cardiovascular risk factors in patients with serious mental illness. That problem needs to be addressed, and Dr. De Picker offered her personal recommendations for doing so in a manner consistent with the evidence to date suggestive of potential mental health benefits of some cardiovascular medications.

She advised that, for treatment of hypertension in patients with bipolar disorder or major depression, an ACE inhibitor or angiotensin-converting enzyme inhibitor is preferred as first-line. There is some evidence to suggest lipophilic beta-blockers, which cross the blood-brain barrier, improve anxiety symptoms and panic attacks, and prevent memory consolidation in patients with posttraumatic stress disorder. But the Scottish data suggest that they may worsen mood disorders.

“I would be careful in using beta-blockers as first-line treatment for hypertension. They’re not in the guidelines for anxiety disorders. British guidelines recommend them to prevent memory consolidation in PTSD, but do not use them as first-line in patients with major depressive disorder or bipolar disorder,” she said. As for calcium channel blockers, the jury is still out, with mixed and inconsistent evidence to date as to the impact of this drug class on mental illness outcomes.

She recommended a very low threshold for prescribing statin therapy in patients with serious mental illness in light of the superb risk/benefit ratio for this drug class. She makes sure a statin is onboard in her patients with schizophrenia, major depressive disorder, or bipolar disorder who are over age 60. In her younger patients, she turns for guidance to an online calculator of an individual’s 10-year risk of a first acute MI or stroke.

Metformin has been shown to be beneficial for addressing the weight gain and other adverse metabolic effects caused by antipsychotic agents, and there is some preliminary evidence of improved psychiatric outcomes in patients with serious mental illness.

Christian Otte, MD, who also spoke at the session, noted that not only do emerging data point to the possibility that cardiovascular drugs might have benefit in terms of psychiatric outcomes, there is also some evidence, albeit mixed, that the converse is true: that is, psychiatric drugs may have cardiovascular benefits. He pointed to a South Korean trial in which 300 patients with a recent acute coronary syndrome and major depression were randomized to 24 weeks of escitalopram or placebo. At median 8.1 years of follow-up, the group that received the SSRI had a 31% relative risk reduction in the primary composite endpoint of all-cause mortality, acute MI, or percutaneous coronary intervention (JAMA. 2018 Jul 24; 320[4]:350–7).

“Potentially independent of their antidepressant effects, some SSRIs’ antiplatelet effects could be beneficial for patients with coronary heart disease, although the jury is still open regarding this question, with evidence in both directions,” said Dr. Otte, professor of psychiatry at Charite University Medical Center in Berlin.

Dr. De Picker offered an example as well: Finnish psychiatrists recently reported that cardiovascular mortality was reduced by an adjusted 38% during periods when 62,250 Finnish schizophrenia patients were on antipsychotic agents, compared with periods of nonuse of the drugs in a national study with a median 14.1 years of follow-up (World Psychiatry. 2020 Feb;19[1]:61-8).

“What they discovered – and this is quite contrary to what we are used to hearing about antipsychotic medication and cardiovascular risk – is that while the number of cardiovascular hospitalizations was not different in periods with or without antipsychotic use, the cardiovascular mortality was quite strikingly reduced when patients were on antipsychotic medication,” she said.

Asked by an audience member whether she personally prescribes metformin, Dr. De Picker replied: “Well, yes, why not? One of the very nice things about metformin is that it is actually a very safe drug, even in the hands of nonspecialists.

“I understand that maybe psychiatrists may not feel very comfortable in starting patients on metformin due to a lack of experience. But there are really only two things you need to take into account. About one-quarter of patients will experience GI side effects – nausea, vomiting, abdominal discomfort – and this can be reduced by gradually uptitrating the dose, dosing at mealtime, and using an extended-release formulation. And the second thing is that metformin can impair vitamin B₁₂ absorption, so I think, especially in psychiatric patients, it would be good to do an annual measurement of vitamin B₁₂ level and, if necessary, administer intramuscular supplements,” Dr. De Picker said.

She reported having no financial conflicts regarding her presentation.

[email protected]

SOURCE: De Picker L. ECNP 2020. Session EDU.05.

One of the hottest topics now in psychiatry is the possibility of repurposing long-established cardiovascular medications for treatment of patients with serious mental illness, Livia De Picker, MD, PhD, said at the virtual congress of the European College of Neuropsychopharmacology.

Courtesy Dr. Livia De Picker

The appeal is multifold. A huge unmet need exists in psychiatry for new and better treatments with novel mechanisms of action. Many guideline-recommended cardiovascular medications have a long track record, including a well-established safety profile with no surprises, and are available in generic versions. They can be developed for a new indication at minimal cost, noted Dr. De Picker, a psychiatrist at the University of Antwerp (Belgium).

The idea of psychiatric repurposing of drugs originally developed for nonpsychiatric indications is nothing new, she added. Examples include lithium for gout, valproate for epilepsy, and ketamine for anesthesiology.

One hitch in efforts to repurpose cardiovascular medications is that, when psychiatric patients have been included in randomized trials of the drugs’ cardiovascular effects, the psychiatric outcomes often went untallied.

Indeed, the only high-quality randomized trial evidence of psychiatric benefits for any class of cardiovascular medications is for statins, where a modest-sized meta-analysis of six placebo-controlled trials in 339 patients with schizophrenia showed the lipid-lowering agents had benefit for both positive and negative symptoms (Psychiatry Res. 2018 Apr;262:84-93). But that’s not a body of data of sufficient size to be definitive, in Dr. De Picker’s view.

Much of the recent enthusiasm for exploring the potential of cardiovascular drugs for psychiatric conditions comes from hypothesis-generating big data analyses drawn from Scandinavian national patient registries. Danish investigators scrutinized all 1.6 million Danes exposed to six classes of drugs of interest during 2005-2015 and determined that those on long-term statins, low-dose aspirin, ACE inhibitors, angiotensin receptor blockers, or allopurinol were associated with a decreased rate of new-onset depression, while high-dose aspirin and non-aspirin NSAIDs were associated with an increased rate, compared with a 30% random sample of the country’s population (Acta Psychiatr Scand. 2019 Jan;1391:68-77).

Similarly, the Danish group found that continued use of statins, angiotensin agents, or low-dose aspirin was associated with a decreased rate of new-onset bipolar disorder, while high-dose aspirin and other NSAIDs were linked to increased risk (Bipolar Disord. 2019 Aug;[15]:410-8). What these agents have in common, the investigators observed, is that they act on inflammation and potentially on the stress response system.

Meanwhile, Swedish investigators examined the course of 142,691 Swedes with a diagnosis of bipolar disorder, schizophrenia, or nonaffective psychosis during 2005-2016. They determined that, during periods when those individuals were on a statin, calcium channel blocker, or metformin, they had reduced rates of psychiatric hospitalization and self-harm (JAMA Psychiatry. 2019 Apr 1;76[4]:382-90).

Scottish researchers analyzed the health records of 144,066 patients placed on monotherapy for hypertension and determined that the lowest risk for hospitalization for a mood disorder during follow-up was in those prescribed an ACE inhibitor or angiotensin receptor blocker. The risk was significantly higher in patients on a beta-blocker or calcium channel blocker, and intermediate in those on a thiazide diuretic (Hypertension. 2016 Nov;68[5:1132-8).

“Obviously, this is all at a very macro scale and we have no idea whatsoever what this means for individual patients, number needed to treat, or which type of patients would benefit, but it does provide us with some guidance for future research,” according to Dr. De Picker.

In the meantime, while physicians await definitive evidence of any impact of cardiovascular drugs might have on psychiatric outcomes, abundant data exist underscoring what she called “shockingly high levels” of inadequate management of cardiovascular risk factors in patients with serious mental illness. That problem needs to be addressed, and Dr. De Picker offered her personal recommendations for doing so in a manner consistent with the evidence to date suggestive of potential mental health benefits of some cardiovascular medications.

She advised that, for treatment of hypertension in patients with bipolar disorder or major depression, an ACE inhibitor or angiotensin-converting enzyme inhibitor is preferred as first-line. There is some evidence to suggest lipophilic beta-blockers, which cross the blood-brain barrier, improve anxiety symptoms and panic attacks, and prevent memory consolidation in patients with posttraumatic stress disorder. But the Scottish data suggest that they may worsen mood disorders.

“I would be careful in using beta-blockers as first-line treatment for hypertension. They’re not in the guidelines for anxiety disorders. British guidelines recommend them to prevent memory consolidation in PTSD, but do not use them as first-line in patients with major depressive disorder or bipolar disorder,” she said. As for calcium channel blockers, the jury is still out, with mixed and inconsistent evidence to date as to the impact of this drug class on mental illness outcomes.

She recommended a very low threshold for prescribing statin therapy in patients with serious mental illness in light of the superb risk/benefit ratio for this drug class. She makes sure a statin is onboard in her patients with schizophrenia, major depressive disorder, or bipolar disorder who are over age 60. In her younger patients, she turns for guidance to an online calculator of an individual’s 10-year risk of a first acute MI or stroke.

Metformin has been shown to be beneficial for addressing the weight gain and other adverse metabolic effects caused by antipsychotic agents, and there is some preliminary evidence of improved psychiatric outcomes in patients with serious mental illness.

Christian Otte, MD, who also spoke at the session, noted that not only do emerging data point to the possibility that cardiovascular drugs might have benefit in terms of psychiatric outcomes, there is also some evidence, albeit mixed, that the converse is true: that is, psychiatric drugs may have cardiovascular benefits. He pointed to a South Korean trial in which 300 patients with a recent acute coronary syndrome and major depression were randomized to 24 weeks of escitalopram or placebo. At median 8.1 years of follow-up, the group that received the SSRI had a 31% relative risk reduction in the primary composite endpoint of all-cause mortality, acute MI, or percutaneous coronary intervention (JAMA. 2018 Jul 24; 320[4]:350–7).

“Potentially independent of their antidepressant effects, some SSRIs’ antiplatelet effects could be beneficial for patients with coronary heart disease, although the jury is still open regarding this question, with evidence in both directions,” said Dr. Otte, professor of psychiatry at Charite University Medical Center in Berlin.

Dr. De Picker offered an example as well: Finnish psychiatrists recently reported that cardiovascular mortality was reduced by an adjusted 38% during periods when 62,250 Finnish schizophrenia patients were on antipsychotic agents, compared with periods of nonuse of the drugs in a national study with a median 14.1 years of follow-up (World Psychiatry. 2020 Feb;19[1]:61-8).

“What they discovered – and this is quite contrary to what we are used to hearing about antipsychotic medication and cardiovascular risk – is that while the number of cardiovascular hospitalizations was not different in periods with or without antipsychotic use, the cardiovascular mortality was quite strikingly reduced when patients were on antipsychotic medication,” she said.

Asked by an audience member whether she personally prescribes metformin, Dr. De Picker replied: “Well, yes, why not? One of the very nice things about metformin is that it is actually a very safe drug, even in the hands of nonspecialists.

“I understand that maybe psychiatrists may not feel very comfortable in starting patients on metformin due to a lack of experience. But there are really only two things you need to take into account. About one-quarter of patients will experience GI side effects – nausea, vomiting, abdominal discomfort – and this can be reduced by gradually uptitrating the dose, dosing at mealtime, and using an extended-release formulation. And the second thing is that metformin can impair vitamin B₁₂ absorption, so I think, especially in psychiatric patients, it would be good to do an annual measurement of vitamin B₁₂ level and, if necessary, administer intramuscular supplements,” Dr. De Picker said.

She reported having no financial conflicts regarding her presentation.

[email protected]

SOURCE: De Picker L. ECNP 2020. Session EDU.05.

One of the hottest topics now in psychiatry is the possibility of repurposing long-established cardiovascular medications for treatment of patients with serious mental illness, Livia De Picker, MD, PhD, said at the virtual congress of the European College of Neuropsychopharmacology.

Courtesy Dr. Livia De Picker

The appeal is multifold. A huge unmet need exists in psychiatry for new and better treatments with novel mechanisms of action. Many guideline-recommended cardiovascular medications have a long track record, including a well-established safety profile with no surprises, and are available in generic versions. They can be developed for a new indication at minimal cost, noted Dr. De Picker, a psychiatrist at the University of Antwerp (Belgium).

The idea of psychiatric repurposing of drugs originally developed for nonpsychiatric indications is nothing new, she added. Examples include lithium for gout, valproate for epilepsy, and ketamine for anesthesiology.

One hitch in efforts to repurpose cardiovascular medications is that, when psychiatric patients have been included in randomized trials of the drugs’ cardiovascular effects, the psychiatric outcomes often went untallied.

Indeed, the only high-quality randomized trial evidence of psychiatric benefits for any class of cardiovascular medications is for statins, where a modest-sized meta-analysis of six placebo-controlled trials in 339 patients with schizophrenia showed the lipid-lowering agents had benefit for both positive and negative symptoms (Psychiatry Res. 2018 Apr;262:84-93). But that’s not a body of data of sufficient size to be definitive, in Dr. De Picker’s view.

Much of the recent enthusiasm for exploring the potential of cardiovascular drugs for psychiatric conditions comes from hypothesis-generating big data analyses drawn from Scandinavian national patient registries. Danish investigators scrutinized all 1.6 million Danes exposed to six classes of drugs of interest during 2005-2015 and determined that those on long-term statins, low-dose aspirin, ACE inhibitors, angiotensin receptor blockers, or allopurinol were associated with a decreased rate of new-onset depression, while high-dose aspirin and non-aspirin NSAIDs were associated with an increased rate, compared with a 30% random sample of the country’s population (Acta Psychiatr Scand. 2019 Jan;1391:68-77).

Similarly, the Danish group found that continued use of statins, angiotensin agents, or low-dose aspirin was associated with a decreased rate of new-onset bipolar disorder, while high-dose aspirin and other NSAIDs were linked to increased risk (Bipolar Disord. 2019 Aug;[15]:410-8). What these agents have in common, the investigators observed, is that they act on inflammation and potentially on the stress response system.

Meanwhile, Swedish investigators examined the course of 142,691 Swedes with a diagnosis of bipolar disorder, schizophrenia, or nonaffective psychosis during 2005-2016. They determined that, during periods when those individuals were on a statin, calcium channel blocker, or metformin, they had reduced rates of psychiatric hospitalization and self-harm (JAMA Psychiatry. 2019 Apr 1;76[4]:382-90).

Scottish researchers analyzed the health records of 144,066 patients placed on monotherapy for hypertension and determined that the lowest risk for hospitalization for a mood disorder during follow-up was in those prescribed an ACE inhibitor or angiotensin receptor blocker. The risk was significantly higher in patients on a beta-blocker or calcium channel blocker, and intermediate in those on a thiazide diuretic (Hypertension. 2016 Nov;68[5:1132-8).

“Obviously, this is all at a very macro scale and we have no idea whatsoever what this means for individual patients, number needed to treat, or which type of patients would benefit, but it does provide us with some guidance for future research,” according to Dr. De Picker.

In the meantime, while physicians await definitive evidence of any impact of cardiovascular drugs might have on psychiatric outcomes, abundant data exist underscoring what she called “shockingly high levels” of inadequate management of cardiovascular risk factors in patients with serious mental illness. That problem needs to be addressed, and Dr. De Picker offered her personal recommendations for doing so in a manner consistent with the evidence to date suggestive of potential mental health benefits of some cardiovascular medications.

She advised that, for treatment of hypertension in patients with bipolar disorder or major depression, an ACE inhibitor or angiotensin-converting enzyme inhibitor is preferred as first-line. There is some evidence to suggest lipophilic beta-blockers, which cross the blood-brain barrier, improve anxiety symptoms and panic attacks, and prevent memory consolidation in patients with posttraumatic stress disorder. But the Scottish data suggest that they may worsen mood disorders.

“I would be careful in using beta-blockers as first-line treatment for hypertension. They’re not in the guidelines for anxiety disorders. British guidelines recommend them to prevent memory consolidation in PTSD, but do not use them as first-line in patients with major depressive disorder or bipolar disorder,” she said. As for calcium channel blockers, the jury is still out, with mixed and inconsistent evidence to date as to the impact of this drug class on mental illness outcomes.

She recommended a very low threshold for prescribing statin therapy in patients with serious mental illness in light of the superb risk/benefit ratio for this drug class. She makes sure a statin is onboard in her patients with schizophrenia, major depressive disorder, or bipolar disorder who are over age 60. In her younger patients, she turns for guidance to an online calculator of an individual’s 10-year risk of a first acute MI or stroke.

Metformin has been shown to be beneficial for addressing the weight gain and other adverse metabolic effects caused by antipsychotic agents, and there is some preliminary evidence of improved psychiatric outcomes in patients with serious mental illness.

Christian Otte, MD, who also spoke at the session, noted that not only do emerging data point to the possibility that cardiovascular drugs might have benefit in terms of psychiatric outcomes, there is also some evidence, albeit mixed, that the converse is true: that is, psychiatric drugs may have cardiovascular benefits. He pointed to a South Korean trial in which 300 patients with a recent acute coronary syndrome and major depression were randomized to 24 weeks of escitalopram or placebo. At median 8.1 years of follow-up, the group that received the SSRI had a 31% relative risk reduction in the primary composite endpoint of all-cause mortality, acute MI, or percutaneous coronary intervention (JAMA. 2018 Jul 24; 320[4]:350–7).

“Potentially independent of their antidepressant effects, some SSRIs’ antiplatelet effects could be beneficial for patients with coronary heart disease, although the jury is still open regarding this question, with evidence in both directions,” said Dr. Otte, professor of psychiatry at Charite University Medical Center in Berlin.

Dr. De Picker offered an example as well: Finnish psychiatrists recently reported that cardiovascular mortality was reduced by an adjusted 38% during periods when 62,250 Finnish schizophrenia patients were on antipsychotic agents, compared with periods of nonuse of the drugs in a national study with a median 14.1 years of follow-up (World Psychiatry. 2020 Feb;19[1]:61-8).

“What they discovered – and this is quite contrary to what we are used to hearing about antipsychotic medication and cardiovascular risk – is that while the number of cardiovascular hospitalizations was not different in periods with or without antipsychotic use, the cardiovascular mortality was quite strikingly reduced when patients were on antipsychotic medication,” she said.

Asked by an audience member whether she personally prescribes metformin, Dr. De Picker replied: “Well, yes, why not? One of the very nice things about metformin is that it is actually a very safe drug, even in the hands of nonspecialists.

“I understand that maybe psychiatrists may not feel very comfortable in starting patients on metformin due to a lack of experience. But there are really only two things you need to take into account. About one-quarter of patients will experience GI side effects – nausea, vomiting, abdominal discomfort – and this can be reduced by gradually uptitrating the dose, dosing at mealtime, and using an extended-release formulation. And the second thing is that metformin can impair vitamin B₁₂ absorption, so I think, especially in psychiatric patients, it would be good to do an annual measurement of vitamin B₁₂ level and, if necessary, administer intramuscular supplements,” Dr. De Picker said.

She reported having no financial conflicts regarding her presentation.

[email protected]

SOURCE: De Picker L. ECNP 2020. Session EDU.05.

Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. What steps families ultimately take about Halloween will hinge on where they live and what the COVID infection and death rates are in their area, advised pediatrician Shelly Vaziri Flais, MD.

Courtesy Andrew Beattie

Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.

For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.

The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”

The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.

Courtesy Dr. Shelly V. Flais

“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.

In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.

Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.

“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.

AAP-recommended Do’s and Don’ts for celebrating Halloween

DO:

• Avoid large gatherings.
• Maintain 6 feet distance.
• Wear cloth masks and wash hands often.
• Use hand sanitizer before and after visiting pumpkin patches and apple orchards.

DON’T:

• Wear painted cloth masks since paints can contain toxins that should not be breathed.
• Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
• Wear cloth mask under costume mask.
• Attend indoor parties or haunted houses.

CDC safety considerations (supplemental to state and local safety laws)

• Assess current cases and overall spread in your community before making any plans.
• Choose outdoor venues or indoor facilities that are well ventilated.
• Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
• If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
• If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
• Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
• Avoid touching your nose, eyes, and mouth.
• For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.

Suggested safe, fun activities

• Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
• Participate in socially distanced outdoor community events at local parks, zoos, etc.
• Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
• Decorate pumpkins.
• Cook a Halloween-themed meal.
• If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
• When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
• Wipe down all goodies received and consider quarantining them for a few days.
• Always wash hands before and after trick-or-treating and when handling treats.

Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. What steps families ultimately take about Halloween will hinge on where they live and what the COVID infection and death rates are in their area, advised pediatrician Shelly Vaziri Flais, MD.

Courtesy Andrew Beattie

Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.

For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.

The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”

The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.

Courtesy Dr. Shelly V. Flais

“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.

In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.

Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.

“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.

AAP-recommended Do’s and Don’ts for celebrating Halloween

DO:

• Avoid large gatherings.
• Maintain 6 feet distance.
• Wear cloth masks and wash hands often.
• Use hand sanitizer before and after visiting pumpkin patches and apple orchards.

DON’T:

• Wear painted cloth masks since paints can contain toxins that should not be breathed.
• Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
• Wear cloth mask under costume mask.
• Attend indoor parties or haunted houses.

CDC safety considerations (supplemental to state and local safety laws)

• Assess current cases and overall spread in your community before making any plans.
• Choose outdoor venues or indoor facilities that are well ventilated.
• Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
• If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
• If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
• Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
• Avoid touching your nose, eyes, and mouth.
• For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.

Suggested safe, fun activities

• Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
• Participate in socially distanced outdoor community events at local parks, zoos, etc.
• Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
• Decorate pumpkins.
• Cook a Halloween-themed meal.
• If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
• When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
• Wipe down all goodies received and consider quarantining them for a few days.
• Always wash hands before and after trick-or-treating and when handling treats.

Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. What steps families ultimately take about Halloween will hinge on where they live and what the COVID infection and death rates are in their area, advised pediatrician Shelly Vaziri Flais, MD.

Courtesy Andrew Beattie

Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.

For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.

The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”

The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.

Courtesy Dr. Shelly V. Flais

“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.

In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.

Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.

“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.

AAP-recommended Do’s and Don’ts for celebrating Halloween

DO:

• Avoid large gatherings.
• Maintain 6 feet distance.
• Wear cloth masks and wash hands often.
• Use hand sanitizer before and after visiting pumpkin patches and apple orchards.

DON’T:

• Wear painted cloth masks since paints can contain toxins that should not be breathed.
• Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
• Wear cloth mask under costume mask.
• Attend indoor parties or haunted houses.

CDC safety considerations (supplemental to state and local safety laws)

• Assess current cases and overall spread in your community before making any plans.
• Choose outdoor venues or indoor facilities that are well ventilated.
• Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
• If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
• If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
• Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
• Avoid touching your nose, eyes, and mouth.
• For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.

Suggested safe, fun activities

• Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
• Participate in socially distanced outdoor community events at local parks, zoos, etc.
• Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
• Decorate pumpkins.
• Cook a Halloween-themed meal.
• If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
• When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
• Wipe down all goodies received and consider quarantining them for a few days.
• Always wash hands before and after trick-or-treating and when handling treats.

Gender-incongruent youth who present for gender-affirming medical care later in adolescence have higher rates of mental health problems than their younger counterparts, based on data from a review of 300 individuals.

Peerayot/Thinkstock.com

“Puberty is a vulnerable time for youth with gender dysphoria because distress may intensify with the development of secondary sex characteristics corresponding to the assigned rather than the experienced gender,” wrote Julia C. Sorbara, MD, of the University of Toronto and the Hospital for Sick Children, also in Toronto, and colleagues.

Although gender-affirming medical care (GAMC) in the form of hormone blockers and/or gender-affirming hormones early in puberty can decrease in emotional and behavioral problems, many teens present later in puberty, and the relationship between pubertal stage at presentation for treatment and mental health has not been examined, they wrote.

In a study published in Pediatrics, the researchers reviewed data from youth with gender incongruence who were seen at a single center; 116 were younger than 15 years at presentation for GAMC and were defined as younger-presenting youth (YPY), and 184 patients aged 15 years and older were defined as older-presenting youth (OPY).

Overall, 78% of the youth reported at least one mental health problem at their initial visit. Significantly more OPY than YPY reported diagnosed depression (46% vs. 30%), self-harm (40% vs. 28%), suicidal thoughts (52% vs. 40%), suicide attempts (17% vs. 9%), and use of psychoactive medications (36% vs. 23%), all with P < .05.

In a multivariate analysis, patients in Tanner stages 4 and 5 were five times more likely to experience depressive disorders (odds ratio, 5.49) and four times as likely to experience depressive disorders (OR, 4.18) as those in earlier Tanner stages. Older age remained significantly associated with use of psychoactive medications (OR, 1.31), but not with anxiety or depression, the researchers wrote.

The YPY group were significantly younger at the age of recognizing gender incongruence, compared with the OPY group, with median ages at recognition of 5.8 years and 9 years, respectively, and younger patients came out about their gender identity at an average of 12 years, compared with 15 years for older patients.

The quantitative data are among the first to relate pubertal stage to mental health in gender-incongruent youth, “supporting clinical observations that pubertal development, menses, and erections are distressing to these youth and consistent with the beneficial role of pubertal suppression, even when used as monotherapy without gender-affirming hormones,” Dr. Sorbara and associates wrote.

The study findings were limited by several factors including the cross-sectional design and the collection of mental health data at only one time point and by the use of self-reports. However, the results suggest that “[gender-incongruent] youth who present to GAMC later in life are a particularly high-risk subset of a vulnerable population,” they noted. “Further study is required to better describe the mental health trajectories of transgender youth and determine if mental health status or age at initiation of GAMC is correlated with psychological well-being in adulthood.”
 

Don’t rush to puberty suppression in younger teens

To reduce the stress of puberty on gender-nonconforming youth, puberty suppression as “a reversible medical intervention” was introduced by Dutch clinicians in the early 2000s, Annelou L.C. de Vries, MD, PhD, of Amsterdam University Medical Center, wrote in an accompanying editorial.

“The aim of puberty suppression was to prevent the psychological suffering stemming from undesired physical changes when puberty starts and allowing the adolescent time to make plans regarding further transition or not,” Dr. de Vries said. “Following this rationale, younger age at the time of starting medical-affirming treatment (puberty suppression or hormones) would be expected to correlate with fewer psychological difficulties related to physical changes than older individuals,” which was confirmed in the current study.

However, clinicians should be cautious in offering puberty suppression at a younger age, in part because “despite the increased availability of gender-affirming medical interventions for younger ages in recent years, there has not been a proportional decline in older presenting youth with gender incongruence,” she said.

More data are needed on youth with postpuberty adolescent-onset transgender histories. The original Dutch studies on gender-affirming medical interventions note case histories describing “the complexities that may be associated with later-presenting transgender adolescents and describe that some eventually detransition,” Dr. de Vries explained.

Ultimately, prospective studies with longer follow-up data are needed to better inform clinicians in developing an individualized treatment plan for youth with gender incongruence, Dr. de Vries concluded.
 

Care barriers can include parents, access, insurance

The study authors describe the situation of gender-affirming medical care in teens perfectly, M. Brett Cooper, MD, of the University of Texas Southwestern Medical Center/Children’s Health Dallas, said in an interview.

Given a variety of factors that need further exploration, “many youth often don’t end up seeking gender-affirming medical care until puberty has progressed to near full maturity,” he said. “The findings from this study provide preliminary evidence to show that if we can identify these youth earlier in their gender journey, we might be able to impact adverse mental health outcomes in a positive way.”

Dr. Cooper said he was not surprised by the study findings. “They are similar to what I see in my clinic.

“Many of our patients often don’t present for medical care until around age 15 or older, similar to the findings of the study,” he added. “The majority of our patients have had a diagnosis of anxiety or depression at some point in their lifetime, including inpatient hospitalizations for their mental health.”

One of the most important barriers to care often can be parents or guardians, said Dr. Cooper. “Young people usually know their gender identity by about age 4-5 but parents may think that a gender-diverse identity could simply be a ‘phase.’ Other times, young people may hide their identity out of fear of a negative reaction from their parents. The distress around identity may become more pronounced once pubertal changes, such as breast and testicle development, begin to worsen their dysphoria.”

“Another barrier to care can be the inability to find a competent, gender-affirming provider,” Dr. Cooper said. “Most large United States cities have at least one gender-affirming clinic, but for those youth who grow up in smaller towns, it may be difficult to access these clinics. In addition, some clinics require a letter from a therapist stating that the young person is transgender before they can be seen for medical care. This creates an access barrier, as it may be difficult not just to find a therapist but one who has experience working with gender-diverse youth.”

Insurance coverage, including lack thereof, is yet another barrier to care for transgender youth, said Dr. Cooper. “While many insurance companies have begun to cover medications such as testosterone and estrogen for gender-affirming care, many still have exclusions on things like puberty blockers and surgical interventions.” These interventions can be lifesaving, but financially prohibitive for many families if not covered by insurance.

As for the value of early timing of gender-affirming care, Dr. Cooper agreed with the study findings that the earlier that a young person can get into medical care for their gender identity, the better chance there is to reduce the prevalence of serious mental health outcomes. “This also prevents the potential development of secondary sexual characteristics, decreasing the need for or amount of surgery in the future if desired,” he said.

“More research is needed to better understand the reasons why many youth don’t present to care until later in puberty. In addition, we need better research on interventions that are effective at reducing serious mental health events in transgender and gender diverse youth,” Dr. Cooper stated. “Another area that I would like to see researched is looking at the mental health of non-Caucasian youth. As the authors noted in their study, many clinics have a high percentage of patients presenting for care who identify as White or Caucasian, and we need to better understand why these other youth are not presenting for care.”

The study received no outside funding. Dr. Sorbara disclosed salary support from the Canadian Pediatric Endocrine Group fellowship program. Dr. de Vries had no financial conflicts to disclose. Dr. Cooper had no financial conflicts to disclose, and serves as a contributor to LGBTQ Youth Consult in Pediatric News.

SOURCES: Sorbara JC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2019-3600; de Vries ALC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2020-010611.

Gender-incongruent youth who present for gender-affirming medical care later in adolescence have higher rates of mental health problems than their younger counterparts, based on data from a review of 300 individuals.

Peerayot/Thinkstock.com

“Puberty is a vulnerable time for youth with gender dysphoria because distress may intensify with the development of secondary sex characteristics corresponding to the assigned rather than the experienced gender,” wrote Julia C. Sorbara, MD, of the University of Toronto and the Hospital for Sick Children, also in Toronto, and colleagues.

Although gender-affirming medical care (GAMC) in the form of hormone blockers and/or gender-affirming hormones early in puberty can decrease in emotional and behavioral problems, many teens present later in puberty, and the relationship between pubertal stage at presentation for treatment and mental health has not been examined, they wrote.

In a study published in Pediatrics, the researchers reviewed data from youth with gender incongruence who were seen at a single center; 116 were younger than 15 years at presentation for GAMC and were defined as younger-presenting youth (YPY), and 184 patients aged 15 years and older were defined as older-presenting youth (OPY).

Overall, 78% of the youth reported at least one mental health problem at their initial visit. Significantly more OPY than YPY reported diagnosed depression (46% vs. 30%), self-harm (40% vs. 28%), suicidal thoughts (52% vs. 40%), suicide attempts (17% vs. 9%), and use of psychoactive medications (36% vs. 23%), all with P < .05.

In a multivariate analysis, patients in Tanner stages 4 and 5 were five times more likely to experience depressive disorders (odds ratio, 5.49) and four times as likely to experience depressive disorders (OR, 4.18) as those in earlier Tanner stages. Older age remained significantly associated with use of psychoactive medications (OR, 1.31), but not with anxiety or depression, the researchers wrote.

The YPY group were significantly younger at the age of recognizing gender incongruence, compared with the OPY group, with median ages at recognition of 5.8 years and 9 years, respectively, and younger patients came out about their gender identity at an average of 12 years, compared with 15 years for older patients.

The quantitative data are among the first to relate pubertal stage to mental health in gender-incongruent youth, “supporting clinical observations that pubertal development, menses, and erections are distressing to these youth and consistent with the beneficial role of pubertal suppression, even when used as monotherapy without gender-affirming hormones,” Dr. Sorbara and associates wrote.

The study findings were limited by several factors including the cross-sectional design and the collection of mental health data at only one time point and by the use of self-reports. However, the results suggest that “[gender-incongruent] youth who present to GAMC later in life are a particularly high-risk subset of a vulnerable population,” they noted. “Further study is required to better describe the mental health trajectories of transgender youth and determine if mental health status or age at initiation of GAMC is correlated with psychological well-being in adulthood.”
 

Don’t rush to puberty suppression in younger teens

To reduce the stress of puberty on gender-nonconforming youth, puberty suppression as “a reversible medical intervention” was introduced by Dutch clinicians in the early 2000s, Annelou L.C. de Vries, MD, PhD, of Amsterdam University Medical Center, wrote in an accompanying editorial.

“The aim of puberty suppression was to prevent the psychological suffering stemming from undesired physical changes when puberty starts and allowing the adolescent time to make plans regarding further transition or not,” Dr. de Vries said. “Following this rationale, younger age at the time of starting medical-affirming treatment (puberty suppression or hormones) would be expected to correlate with fewer psychological difficulties related to physical changes than older individuals,” which was confirmed in the current study.

However, clinicians should be cautious in offering puberty suppression at a younger age, in part because “despite the increased availability of gender-affirming medical interventions for younger ages in recent years, there has not been a proportional decline in older presenting youth with gender incongruence,” she said.

More data are needed on youth with postpuberty adolescent-onset transgender histories. The original Dutch studies on gender-affirming medical interventions note case histories describing “the complexities that may be associated with later-presenting transgender adolescents and describe that some eventually detransition,” Dr. de Vries explained.

Ultimately, prospective studies with longer follow-up data are needed to better inform clinicians in developing an individualized treatment plan for youth with gender incongruence, Dr. de Vries concluded.
 

Care barriers can include parents, access, insurance

The study authors describe the situation of gender-affirming medical care in teens perfectly, M. Brett Cooper, MD, of the University of Texas Southwestern Medical Center/Children’s Health Dallas, said in an interview.

Given a variety of factors that need further exploration, “many youth often don’t end up seeking gender-affirming medical care until puberty has progressed to near full maturity,” he said. “The findings from this study provide preliminary evidence to show that if we can identify these youth earlier in their gender journey, we might be able to impact adverse mental health outcomes in a positive way.”

Dr. Cooper said he was not surprised by the study findings. “They are similar to what I see in my clinic.

“Many of our patients often don’t present for medical care until around age 15 or older, similar to the findings of the study,” he added. “The majority of our patients have had a diagnosis of anxiety or depression at some point in their lifetime, including inpatient hospitalizations for their mental health.”

One of the most important barriers to care often can be parents or guardians, said Dr. Cooper. “Young people usually know their gender identity by about age 4-5 but parents may think that a gender-diverse identity could simply be a ‘phase.’ Other times, young people may hide their identity out of fear of a negative reaction from their parents. The distress around identity may become more pronounced once pubertal changes, such as breast and testicle development, begin to worsen their dysphoria.”

“Another barrier to care can be the inability to find a competent, gender-affirming provider,” Dr. Cooper said. “Most large United States cities have at least one gender-affirming clinic, but for those youth who grow up in smaller towns, it may be difficult to access these clinics. In addition, some clinics require a letter from a therapist stating that the young person is transgender before they can be seen for medical care. This creates an access barrier, as it may be difficult not just to find a therapist but one who has experience working with gender-diverse youth.”

Insurance coverage, including lack thereof, is yet another barrier to care for transgender youth, said Dr. Cooper. “While many insurance companies have begun to cover medications such as testosterone and estrogen for gender-affirming care, many still have exclusions on things like puberty blockers and surgical interventions.” These interventions can be lifesaving, but financially prohibitive for many families if not covered by insurance.

As for the value of early timing of gender-affirming care, Dr. Cooper agreed with the study findings that the earlier that a young person can get into medical care for their gender identity, the better chance there is to reduce the prevalence of serious mental health outcomes. “This also prevents the potential development of secondary sexual characteristics, decreasing the need for or amount of surgery in the future if desired,” he said.

“More research is needed to better understand the reasons why many youth don’t present to care until later in puberty. In addition, we need better research on interventions that are effective at reducing serious mental health events in transgender and gender diverse youth,” Dr. Cooper stated. “Another area that I would like to see researched is looking at the mental health of non-Caucasian youth. As the authors noted in their study, many clinics have a high percentage of patients presenting for care who identify as White or Caucasian, and we need to better understand why these other youth are not presenting for care.”

The study received no outside funding. Dr. Sorbara disclosed salary support from the Canadian Pediatric Endocrine Group fellowship program. Dr. de Vries had no financial conflicts to disclose. Dr. Cooper had no financial conflicts to disclose, and serves as a contributor to LGBTQ Youth Consult in Pediatric News.

SOURCES: Sorbara JC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2019-3600; de Vries ALC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2020-010611.

Gender-incongruent youth who present for gender-affirming medical care later in adolescence have higher rates of mental health problems than their younger counterparts, based on data from a review of 300 individuals.

Peerayot/Thinkstock.com

“Puberty is a vulnerable time for youth with gender dysphoria because distress may intensify with the development of secondary sex characteristics corresponding to the assigned rather than the experienced gender,” wrote Julia C. Sorbara, MD, of the University of Toronto and the Hospital for Sick Children, also in Toronto, and colleagues.

Although gender-affirming medical care (GAMC) in the form of hormone blockers and/or gender-affirming hormones early in puberty can decrease in emotional and behavioral problems, many teens present later in puberty, and the relationship between pubertal stage at presentation for treatment and mental health has not been examined, they wrote.

In a study published in Pediatrics, the researchers reviewed data from youth with gender incongruence who were seen at a single center; 116 were younger than 15 years at presentation for GAMC and were defined as younger-presenting youth (YPY), and 184 patients aged 15 years and older were defined as older-presenting youth (OPY).

Overall, 78% of the youth reported at least one mental health problem at their initial visit. Significantly more OPY than YPY reported diagnosed depression (46% vs. 30%), self-harm (40% vs. 28%), suicidal thoughts (52% vs. 40%), suicide attempts (17% vs. 9%), and use of psychoactive medications (36% vs. 23%), all with P < .05.

In a multivariate analysis, patients in Tanner stages 4 and 5 were five times more likely to experience depressive disorders (odds ratio, 5.49) and four times as likely to experience depressive disorders (OR, 4.18) as those in earlier Tanner stages. Older age remained significantly associated with use of psychoactive medications (OR, 1.31), but not with anxiety or depression, the researchers wrote.

The YPY group were significantly younger at the age of recognizing gender incongruence, compared with the OPY group, with median ages at recognition of 5.8 years and 9 years, respectively, and younger patients came out about their gender identity at an average of 12 years, compared with 15 years for older patients.

The quantitative data are among the first to relate pubertal stage to mental health in gender-incongruent youth, “supporting clinical observations that pubertal development, menses, and erections are distressing to these youth and consistent with the beneficial role of pubertal suppression, even when used as monotherapy without gender-affirming hormones,” Dr. Sorbara and associates wrote.

The study findings were limited by several factors including the cross-sectional design and the collection of mental health data at only one time point and by the use of self-reports. However, the results suggest that “[gender-incongruent] youth who present to GAMC later in life are a particularly high-risk subset of a vulnerable population,” they noted. “Further study is required to better describe the mental health trajectories of transgender youth and determine if mental health status or age at initiation of GAMC is correlated with psychological well-being in adulthood.”
 

Don’t rush to puberty suppression in younger teens

To reduce the stress of puberty on gender-nonconforming youth, puberty suppression as “a reversible medical intervention” was introduced by Dutch clinicians in the early 2000s, Annelou L.C. de Vries, MD, PhD, of Amsterdam University Medical Center, wrote in an accompanying editorial.

“The aim of puberty suppression was to prevent the psychological suffering stemming from undesired physical changes when puberty starts and allowing the adolescent time to make plans regarding further transition or not,” Dr. de Vries said. “Following this rationale, younger age at the time of starting medical-affirming treatment (puberty suppression or hormones) would be expected to correlate with fewer psychological difficulties related to physical changes than older individuals,” which was confirmed in the current study.

However, clinicians should be cautious in offering puberty suppression at a younger age, in part because “despite the increased availability of gender-affirming medical interventions for younger ages in recent years, there has not been a proportional decline in older presenting youth with gender incongruence,” she said.

More data are needed on youth with postpuberty adolescent-onset transgender histories. The original Dutch studies on gender-affirming medical interventions note case histories describing “the complexities that may be associated with later-presenting transgender adolescents and describe that some eventually detransition,” Dr. de Vries explained.

Ultimately, prospective studies with longer follow-up data are needed to better inform clinicians in developing an individualized treatment plan for youth with gender incongruence, Dr. de Vries concluded.
 

Care barriers can include parents, access, insurance

The study authors describe the situation of gender-affirming medical care in teens perfectly, M. Brett Cooper, MD, of the University of Texas Southwestern Medical Center/Children’s Health Dallas, said in an interview.

Given a variety of factors that need further exploration, “many youth often don’t end up seeking gender-affirming medical care until puberty has progressed to near full maturity,” he said. “The findings from this study provide preliminary evidence to show that if we can identify these youth earlier in their gender journey, we might be able to impact adverse mental health outcomes in a positive way.”

Dr. Cooper said he was not surprised by the study findings. “They are similar to what I see in my clinic.

“Many of our patients often don’t present for medical care until around age 15 or older, similar to the findings of the study,” he added. “The majority of our patients have had a diagnosis of anxiety or depression at some point in their lifetime, including inpatient hospitalizations for their mental health.”

One of the most important barriers to care often can be parents or guardians, said Dr. Cooper. “Young people usually know their gender identity by about age 4-5 but parents may think that a gender-diverse identity could simply be a ‘phase.’ Other times, young people may hide their identity out of fear of a negative reaction from their parents. The distress around identity may become more pronounced once pubertal changes, such as breast and testicle development, begin to worsen their dysphoria.”

“Another barrier to care can be the inability to find a competent, gender-affirming provider,” Dr. Cooper said. “Most large United States cities have at least one gender-affirming clinic, but for those youth who grow up in smaller towns, it may be difficult to access these clinics. In addition, some clinics require a letter from a therapist stating that the young person is transgender before they can be seen for medical care. This creates an access barrier, as it may be difficult not just to find a therapist but one who has experience working with gender-diverse youth.”

Insurance coverage, including lack thereof, is yet another barrier to care for transgender youth, said Dr. Cooper. “While many insurance companies have begun to cover medications such as testosterone and estrogen for gender-affirming care, many still have exclusions on things like puberty blockers and surgical interventions.” These interventions can be lifesaving, but financially prohibitive for many families if not covered by insurance.

As for the value of early timing of gender-affirming care, Dr. Cooper agreed with the study findings that the earlier that a young person can get into medical care for their gender identity, the better chance there is to reduce the prevalence of serious mental health outcomes. “This also prevents the potential development of secondary sexual characteristics, decreasing the need for or amount of surgery in the future if desired,” he said.

“More research is needed to better understand the reasons why many youth don’t present to care until later in puberty. In addition, we need better research on interventions that are effective at reducing serious mental health events in transgender and gender diverse youth,” Dr. Cooper stated. “Another area that I would like to see researched is looking at the mental health of non-Caucasian youth. As the authors noted in their study, many clinics have a high percentage of patients presenting for care who identify as White or Caucasian, and we need to better understand why these other youth are not presenting for care.”

The study received no outside funding. Dr. Sorbara disclosed salary support from the Canadian Pediatric Endocrine Group fellowship program. Dr. de Vries had no financial conflicts to disclose. Dr. Cooper had no financial conflicts to disclose, and serves as a contributor to LGBTQ Youth Consult in Pediatric News.

SOURCES: Sorbara JC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2019-3600; de Vries ALC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2020-010611.

As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.

Greg Pollock - Fotolia.com

When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.

When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.

The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. Here in Maine, the organizations responsible for making decisions about school sports struggled for months in making their decision. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.

Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.

There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.

Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.

Greg Pollock - Fotolia.com

When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.

When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.

The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. Here in Maine, the organizations responsible for making decisions about school sports struggled for months in making their decision. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.

Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.

There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.

Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.

Greg Pollock - Fotolia.com

When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.

When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.

The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. Here in Maine, the organizations responsible for making decisions about school sports struggled for months in making their decision. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.

Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.

There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.

Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Adolescent alcohol use among boys was prospectively associated with use of legal performance-enhancing substances in young adulthood, based on prospective cohort data from more than 12,000 individuals, wrote Kyle T. Ganson, PhD, MSW, of the University of Toronto, and colleagues.

Nikada/iStockphoto

In addition, legal use of performance-enhancing substances (PES) among young men was associated with increased risk of alcohol use problems.

Although previous studies have shown a range of adverse effects associated with the use of anabolic-androgenic steroid derivatives (defined as illegal PES), the possible adverse effects of legal PES (defined in this report as protein powders, creatine monohydrate, dehydroepiandrostenedione, and amino acids) have not been well studied, the researchers wrote.

In a study published in Pediatrics, the researchers reviewed data from 12,133 young adults aged 18-26 years who were part of the National Longitudinal Study of Adolescent to Adult Health from 1994 to 2008.

Overall, 16% of young men and 1% of young women reported using legal PES in the past year. Among men, legal PES use was prospectively associated with increased risk of a range of alcohol-related problem behaviors including binge drinking (adjusted odds ratio, 1.35), injurious and risky behaviors (aOR, 1.78), legal problems (aOR, 1.52), reduced activities and socializing (aOR, 1.91), and problems with emotional or physical health (aOR, 1.44).

Legal PES use among young adult women was associated with an increased risk of emotional or physical health problems (aOR, 3.00).
 

Adolescent impact

Between adolescence and young adulthood (an average of 7 years’ follow-up), alcohol use was prospectively associated with legal PES use in young men (OR, 1.39), but neither cigarette smoking nor marijuana use in adolescence was associated with later use of legal PES. Among young women, no type of adolescent substance use was prospectively associated with later use of legal PES.

“To date, legal PES have not been largely considered as part of the spectrum of substances used among adolescents, have not been subject to the same regulatory scrutiny as other substances known to be linked to subsequent substance use and are freely available over the counter to adolescents,” Dr. Ganson and associates noted.

“Clearly, the robust reciprocal temporal relationship between substance use and legal PES suggests that each may serve as a gateway for the other,” they wrote.

The study findings were limited by several factors including the inability to identify outcomes associated with variable PES components, incomplete data collection on several drinking-related risk behaviors, and inability to analyze prospective use of illegal or other substances associated with use of legal PES, the researchers wrote.

However, “these results provide further evidence in support of the gateway theory and prospective health risk behaviors associated with legal PES and substance use,” they wrote.

The data may inform policy on the additional regulation of legal PES use in minors. In the meantime, “it is important for medical providers and clinicians to assess problematic alcohol use and drinking-related risk behaviors among young adult men who have previously used legal PES,” Dr. Ganson and associates concluded.
 

Challenges to clinicians

An important point to recognize is that PES is a misleading term, Steven Cuff, MD, of the Ohio State University, Columbus, and Michele LaBotz, MD, of Tufts University, Boston, wrote in an accompanying editorial. “Most legal supplements marketed for athletic performance enhancement are ineffective at increasing muscle mass or athletic performance beyond what can be achieved through appropriate nutrition and training,” they emphasized. The current study findings suggest that “legal PES should be integrated into the gateway hypothesis regarding patterns and progression of substance use through adolescence and early adulthood,” and support discouragement of any PES use among adolescents and young adults.

Even legal PES can be dangerous because of the lack of oversight of dietary supplements by the Food and Drug Administration. “There is widespread evidence that many over-the-counter dietary supplements lack stated ingredients, contain unlabeled ingredients (including potential allergens), or are contaminated with impurities or illegal or dangerous substances, such as steroids and stimulants,” the editorialists emphasized.

In addition, the association found in the study between muscle dysphoria and both PES use and substance use disorders, notably alcohol-related morbidity, highlights the need for a proactive approach by pediatricians to minimize the risk, they noted.

“For pediatricians uncomfortable with initiating discussions on PES use with their patients, an American Academy of Pediatrics–supported role-play simulation is available,” they concluded.

The study is important because “PES use is ubiquitous among adolescents and young adults,” Dr. LaBotz said in an interview. “Although it is widely believed that PES use serves as a likely ‘gateway’ to use of anabolic steroids and other substances, this is one of the very few studies that explores this relationship. Their findings that alcohol use appears to correlate with subsequent use of PES, and that PES use appears to correlate with future alcohol-related issues, suggest that this is not a simple linear progression of problematic behavior.”

Dr. LaBotz added that she was not surprised by the study findings, and emphasized that pediatric health care providers should be aware of the association between PES and alcohol use. “PES screening should be incorporated into screening done for alcohol and other substance use. This appears to be particularly true for athletes and other subpopulations who are at higher risk for problematic alcohol use.”

She said much of PES use is driven by the desire by young men for a muscular appearance, but more research is needed on young women. “In the past, this was a goal primarily associated with males, but females have become increasingly interested in achieving muscularity as well, which suggests an increasing risk of PES use among females as compared to earlier reports. We need updated data on patterns, prevalence and consequences of PES use in females.”

In addition, “although preparticipation physical examination forms include screening questions for PES use among athletes, further information is needed on how to incorporate PES into substance use screening that is performed in a general pediatric population, such as including athletes and nonathletes,” Dr. LaBotz said.

The study was supported by the National Institutes of Health and by grants to one of the coauthors from the Pediatric Scientist Development Program funded by the American Academy of Pediatrics and the American Pediatric Society, as well as the American Heart Association Career Development Award. The researchers had no financial conflicts to disclose. Dr. Cuff and Dr. LaBotz had no financial conflicts to disclose.

SOURCE: Ganson KT et al. Pediatrics. 2020 Sep. doi: 10.1542/peds.2020-0409.

Adolescent alcohol use among boys was prospectively associated with use of legal performance-enhancing substances in young adulthood, based on prospective cohort data from more than 12,000 individuals, wrote Kyle T. Ganson, PhD, MSW, of the University of Toronto, and colleagues.

Nikada/iStockphoto

In addition, legal use of performance-enhancing substances (PES) among young men was associated with increased risk of alcohol use problems.

Although previous studies have shown a range of adverse effects associated with the use of anabolic-androgenic steroid derivatives (defined as illegal PES), the possible adverse effects of legal PES (defined in this report as protein powders, creatine monohydrate, dehydroepiandrostenedione, and amino acids) have not been well studied, the researchers wrote.

In a study published in Pediatrics, the researchers reviewed data from 12,133 young adults aged 18-26 years who were part of the National Longitudinal Study of Adolescent to Adult Health from 1994 to 2008.

Overall, 16% of young men and 1% of young women reported using legal PES in the past year. Among men, legal PES use was prospectively associated with increased risk of a range of alcohol-related problem behaviors including binge drinking (adjusted odds ratio, 1.35), injurious and risky behaviors (aOR, 1.78), legal problems (aOR, 1.52), reduced activities and socializing (aOR, 1.91), and problems with emotional or physical health (aOR, 1.44).

Legal PES use among young adult women was associated with an increased risk of emotional or physical health problems (aOR, 3.00).
 

Adolescent impact

Between adolescence and young adulthood (an average of 7 years’ follow-up), alcohol use was prospectively associated with legal PES use in young men (OR, 1.39), but neither cigarette smoking nor marijuana use in adolescence was associated with later use of legal PES. Among young women, no type of adolescent substance use was prospectively associated with later use of legal PES.

“To date, legal PES have not been largely considered as part of the spectrum of substances used among adolescents, have not been subject to the same regulatory scrutiny as other substances known to be linked to subsequent substance use and are freely available over the counter to adolescents,” Dr. Ganson and associates noted.

“Clearly, the robust reciprocal temporal relationship between substance use and legal PES suggests that each may serve as a gateway for the other,” they wrote.

The study findings were limited by several factors including the inability to identify outcomes associated with variable PES components, incomplete data collection on several drinking-related risk behaviors, and inability to analyze prospective use of illegal or other substances associated with use of legal PES, the researchers wrote.

However, “these results provide further evidence in support of the gateway theory and prospective health risk behaviors associated with legal PES and substance use,” they wrote.

The data may inform policy on the additional regulation of legal PES use in minors. In the meantime, “it is important for medical providers and clinicians to assess problematic alcohol use and drinking-related risk behaviors among young adult men who have previously used legal PES,” Dr. Ganson and associates concluded.
 

Challenges to clinicians

An important point to recognize is that PES is a misleading term, Steven Cuff, MD, of the Ohio State University, Columbus, and Michele LaBotz, MD, of Tufts University, Boston, wrote in an accompanying editorial. “Most legal supplements marketed for athletic performance enhancement are ineffective at increasing muscle mass or athletic performance beyond what can be achieved through appropriate nutrition and training,” they emphasized. The current study findings suggest that “legal PES should be integrated into the gateway hypothesis regarding patterns and progression of substance use through adolescence and early adulthood,” and support discouragement of any PES use among adolescents and young adults.

Even legal PES can be dangerous because of the lack of oversight of dietary supplements by the Food and Drug Administration. “There is widespread evidence that many over-the-counter dietary supplements lack stated ingredients, contain unlabeled ingredients (including potential allergens), or are contaminated with impurities or illegal or dangerous substances, such as steroids and stimulants,” the editorialists emphasized.

In addition, the association found in the study between muscle dysphoria and both PES use and substance use disorders, notably alcohol-related morbidity, highlights the need for a proactive approach by pediatricians to minimize the risk, they noted.

“For pediatricians uncomfortable with initiating discussions on PES use with their patients, an American Academy of Pediatrics–supported role-play simulation is available,” they concluded.

The study is important because “PES use is ubiquitous among adolescents and young adults,” Dr. LaBotz said in an interview. “Although it is widely believed that PES use serves as a likely ‘gateway’ to use of anabolic steroids and other substances, this is one of the very few studies that explores this relationship. Their findings that alcohol use appears to correlate with subsequent use of PES, and that PES use appears to correlate with future alcohol-related issues, suggest that this is not a simple linear progression of problematic behavior.”

Dr. LaBotz added that she was not surprised by the study findings, and emphasized that pediatric health care providers should be aware of the association between PES and alcohol use. “PES screening should be incorporated into screening done for alcohol and other substance use. This appears to be particularly true for athletes and other subpopulations who are at higher risk for problematic alcohol use.”

She said much of PES use is driven by the desire by young men for a muscular appearance, but more research is needed on young women. “In the past, this was a goal primarily associated with males, but females have become increasingly interested in achieving muscularity as well, which suggests an increasing risk of PES use among females as compared to earlier reports. We need updated data on patterns, prevalence and consequences of PES use in females.”

In addition, “although preparticipation physical examination forms include screening questions for PES use among athletes, further information is needed on how to incorporate PES into substance use screening that is performed in a general pediatric population, such as including athletes and nonathletes,” Dr. LaBotz said.

The study was supported by the National Institutes of Health and by grants to one of the coauthors from the Pediatric Scientist Development Program funded by the American Academy of Pediatrics and the American Pediatric Society, as well as the American Heart Association Career Development Award. The researchers had no financial conflicts to disclose. Dr. Cuff and Dr. LaBotz had no financial conflicts to disclose.

SOURCE: Ganson KT et al. Pediatrics. 2020 Sep. doi: 10.1542/peds.2020-0409.

Adolescent alcohol use among boys was prospectively associated with use of legal performance-enhancing substances in young adulthood, based on prospective cohort data from more than 12,000 individuals, wrote Kyle T. Ganson, PhD, MSW, of the University of Toronto, and colleagues.

Nikada/iStockphoto

In addition, legal use of performance-enhancing substances (PES) among young men was associated with increased risk of alcohol use problems.

Although previous studies have shown a range of adverse effects associated with the use of anabolic-androgenic steroid derivatives (defined as illegal PES), the possible adverse effects of legal PES (defined in this report as protein powders, creatine monohydrate, dehydroepiandrostenedione, and amino acids) have not been well studied, the researchers wrote.

In a study published in Pediatrics, the researchers reviewed data from 12,133 young adults aged 18-26 years who were part of the National Longitudinal Study of Adolescent to Adult Health from 1994 to 2008.

Overall, 16% of young men and 1% of young women reported using legal PES in the past year. Among men, legal PES use was prospectively associated with increased risk of a range of alcohol-related problem behaviors including binge drinking (adjusted odds ratio, 1.35), injurious and risky behaviors (aOR, 1.78), legal problems (aOR, 1.52), reduced activities and socializing (aOR, 1.91), and problems with emotional or physical health (aOR, 1.44).

Legal PES use among young adult women was associated with an increased risk of emotional or physical health problems (aOR, 3.00).
 

Adolescent impact

Between adolescence and young adulthood (an average of 7 years’ follow-up), alcohol use was prospectively associated with legal PES use in young men (OR, 1.39), but neither cigarette smoking nor marijuana use in adolescence was associated with later use of legal PES. Among young women, no type of adolescent substance use was prospectively associated with later use of legal PES.

“To date, legal PES have not been largely considered as part of the spectrum of substances used among adolescents, have not been subject to the same regulatory scrutiny as other substances known to be linked to subsequent substance use and are freely available over the counter to adolescents,” Dr. Ganson and associates noted.

“Clearly, the robust reciprocal temporal relationship between substance use and legal PES suggests that each may serve as a gateway for the other,” they wrote.

The study findings were limited by several factors including the inability to identify outcomes associated with variable PES components, incomplete data collection on several drinking-related risk behaviors, and inability to analyze prospective use of illegal or other substances associated with use of legal PES, the researchers wrote.

However, “these results provide further evidence in support of the gateway theory and prospective health risk behaviors associated with legal PES and substance use,” they wrote.

The data may inform policy on the additional regulation of legal PES use in minors. In the meantime, “it is important for medical providers and clinicians to assess problematic alcohol use and drinking-related risk behaviors among young adult men who have previously used legal PES,” Dr. Ganson and associates concluded.
 

Challenges to clinicians

An important point to recognize is that PES is a misleading term, Steven Cuff, MD, of the Ohio State University, Columbus, and Michele LaBotz, MD, of Tufts University, Boston, wrote in an accompanying editorial. “Most legal supplements marketed for athletic performance enhancement are ineffective at increasing muscle mass or athletic performance beyond what can be achieved through appropriate nutrition and training,” they emphasized. The current study findings suggest that “legal PES should be integrated into the gateway hypothesis regarding patterns and progression of substance use through adolescence and early adulthood,” and support discouragement of any PES use among adolescents and young adults.

Even legal PES can be dangerous because of the lack of oversight of dietary supplements by the Food and Drug Administration. “There is widespread evidence that many over-the-counter dietary supplements lack stated ingredients, contain unlabeled ingredients (including potential allergens), or are contaminated with impurities or illegal or dangerous substances, such as steroids and stimulants,” the editorialists emphasized.

In addition, the association found in the study between muscle dysphoria and both PES use and substance use disorders, notably alcohol-related morbidity, highlights the need for a proactive approach by pediatricians to minimize the risk, they noted.

“For pediatricians uncomfortable with initiating discussions on PES use with their patients, an American Academy of Pediatrics–supported role-play simulation is available,” they concluded.

The study is important because “PES use is ubiquitous among adolescents and young adults,” Dr. LaBotz said in an interview. “Although it is widely believed that PES use serves as a likely ‘gateway’ to use of anabolic steroids and other substances, this is one of the very few studies that explores this relationship. Their findings that alcohol use appears to correlate with subsequent use of PES, and that PES use appears to correlate with future alcohol-related issues, suggest that this is not a simple linear progression of problematic behavior.”

Dr. LaBotz added that she was not surprised by the study findings, and emphasized that pediatric health care providers should be aware of the association between PES and alcohol use. “PES screening should be incorporated into screening done for alcohol and other substance use. This appears to be particularly true for athletes and other subpopulations who are at higher risk for problematic alcohol use.”

She said much of PES use is driven by the desire by young men for a muscular appearance, but more research is needed on young women. “In the past, this was a goal primarily associated with males, but females have become increasingly interested in achieving muscularity as well, which suggests an increasing risk of PES use among females as compared to earlier reports. We need updated data on patterns, prevalence and consequences of PES use in females.”

In addition, “although preparticipation physical examination forms include screening questions for PES use among athletes, further information is needed on how to incorporate PES into substance use screening that is performed in a general pediatric population, such as including athletes and nonathletes,” Dr. LaBotz said.

The study was supported by the National Institutes of Health and by grants to one of the coauthors from the Pediatric Scientist Development Program funded by the American Academy of Pediatrics and the American Pediatric Society, as well as the American Heart Association Career Development Award. The researchers had no financial conflicts to disclose. Dr. Cuff and Dr. LaBotz had no financial conflicts to disclose.

SOURCE: Ganson KT et al. Pediatrics. 2020 Sep. doi: 10.1542/peds.2020-0409.

Microdosing with lysergic acid diethylamide (LSD) is associated with improved mood and increased attention, early research suggests. However, at least one expert believes it’s far too soon to tell and warns against endorsing patient microdosing.

In a dose-finding exploratory study, three low doses of LSD were compared with placebo in healthy volunteers who were all recreational drug users. Adjusted results showed that the highest dose boosted attention and mood, although participants were aware of psychedelic effects, prompting researchers to conclude the results demonstrated “selective, beneficial effects.”

“The majority of participants have improved attention,” study investigator Nadia Hutten, PhD, Department of Neuropsychology and Psychopharmacology, Maastricht University, the Netherlands, told Medscape Medical News.

“So we think that patients with attention deficits might have more beneficial effects,” she added, noting her team plans to study LSD microdosing in patients with attention deficit hyperactivity disorder.

The study was presented at the 33rd European College of Neuropsychopharmacology (ECNP) Congress, which was held online this year because of the COVID-19 pandemic.

Growing interest

Over the past 10 years there has been growing interest in psychedelic microdosing, which is defined as a dose that aims to enhance mood and/or performance but does not affect perception.

However, there has been considerable debate over what constitutes a “microdose.” One tenth of a “full” psychedelic dose is typically suggested, but users report a much wider dose range in practice, suggesting potential “individual variation in response to low doses,” the researchers note.

In the current dose-finding study, the researchers explored whether the effects of LSD on cognition and subjective measures differed between individuals.

The study included 24 healthy recreational drug users and compared the acute effects of 5 mcg, 20 mcg, and 20 mcg LSD with placebo on a computer-based psychomotor vigilance task (PVT) that measured attention and on a Digit Symbol Substitution Test (DSST).

Participants also completed the 72-item Profile of Mood States (POMS) questionnaire, a visual analog scale (VAS) on mood, and the 94-item 5-Dimensional Altered States of Consciousness Rating scales (5D-ASC).

Unadjusted results showed that the 20-mcg LSD dose significantly reduced correct substitutions on the DSST vs placebo (P < .05), but had no effect on attentional lapses on the PCT or on positive mood on the POMS.

Correcting the DSST score for the number of total responses revealed no dose effect of LSD. This suggested that participants were no less accurate when under the influence of LSD, even though they encoded fewer digits, the researchers note.

Participants also reported that both the 10-mcg and 20-mcg dose of LSD increased subjective experiences on the VAS and alternated states of consciousness on the 5D-ASC compared with placebo.

After stratifying the results by dose and participant, the effect of LSD differed between individuals. For example, both the 5-mcg and 20-mcg doses were associated with improvement in attention on the PVT (P < .05), but not the 10-mcg dose.

These results also indicated that the 20-mcg dose was associated with a significant increase in the correct number of substitutions on the DSST and with a significant increase in positive mood on the POMS (P < .05 for both outcomes).

The findings suggest that future studies in patient populations with impaired attention are needed, “including biological parameters involved in LSD receptor-binding and metabolism, in order to understand the inter-individual variation in response to LSD,” the investigators note.

In an educational session at the meeting, the study’s lead researcher, Kim Kuypers, PhD, associate professor at Maastricht University, said research shows individuals are already self-medicating with psychedelic microdosing to treat a wide range of mental health problems, and rated it as significantly more effective than conventional therapy at alleviating symptoms and improving quality of life.

Nevertheless, Kuypers noted there have been fewer than 20 published placebo-controlled studies examining psychedelic microdosing in humans – and much of the current evidence is anecdotal.

However, there is some clinical research suggesting that low-dose LSD is associated with improved mood and cognitive performance and that it also has an effect on resting-state amygdala functional connectivity and acutely increases brain-derived neurotrophic factor plasma levels.

Furthermore, said Kuypers, the evidence in healthy volunteers thus far suggests microdosing is “safe.”
 

Jumping ahead of the science?

Commenting on the study for Medscape Medical News, Jeffrey A. Lieberman, MD, professor and chair of psychiatry at Columbia University, New York City, said he “gives the investigators credit for doing such a study” but does not believe anything can be gleaned from the findings.

He said he is also concerned that the resurgence of psychedelic research is not congruent with “the methodologic rigor and scientific thinking that accompanies treatment development in other disease areas.”

Lieberman, who is also psychiatrist-in-chief at the NewYork–Presbyterian Hospital Columbia Medical Center and was not involved with the study, added that some of the research is also being conducted in individuals who are “true believers and not sufficiently dispassionate and objective.”

“If this was just a treatment . . . for some type of skin fungus, no one would pay any attention to it. But because these are such notorious and interesting compounds, they have attracted a lot of peripheral interest to promote and to disseminate; and the risk is that it will be done in the wrong way and there may be consequences,” he said.

Moreover, Lieberman noted that the psychedelic drugs may be used in practice ahead of strong evidence of safety and efficacy. As an example, he pointed to ketamine, a drug that was identified as a treatment for people with depression who had not responded to standard treatments, he noted.

“But before you knew it, there were clinics being opened up all over the place by anesthesiologists or other people that were trying to make a quick buck,” he said.

“That was alarming because they were stretching the criteria for whom the treatment was appropriate; there were no protocols for dosing, for frequency of administration, and there was inadequate psychiatric follow-up,” Lieberman added.
 

Preliminary but promising

He agreed with Kuypers that cases of microdosing with psychedelics are largely anecdotal.

“So in that context, when these investigators tried to put it to a test, which is commendable, the results in no way tell you whether it’s good, bad, or indifferent,” Lieberman said. In fact, the results are “disappointing in terms of suggesting any beneficial effect.”

Lieberman said more and larger studies are needed in order to determine whether LSD microdosing is beneficial. 

In response to Lieberman’s comments, Kuypers told Medscape Medical News that the investigators tried to base their placebo-controlled research on previous anecdotal research.

She emphasized that the “whole field is still in its infancy,” including research on the use of “full” doses of psychedelics.

“I sometimes think that the message is too positive. We should never forget to communicate that not a lot of research has been done.” In addition, she agreed that researchers should “keep a balanced message.”

“All the data to date is preliminary, in my view, but promising,” she stressed, “and the evidence is growing.”

The study received financial support from the Beckley Foundation. The study authors and Lieberman have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Microdosing with lysergic acid diethylamide (LSD) is associated with improved mood and increased attention, early research suggests. However, at least one expert believes it’s far too soon to tell and warns against endorsing patient microdosing.

In a dose-finding exploratory study, three low doses of LSD were compared with placebo in healthy volunteers who were all recreational drug users. Adjusted results showed that the highest dose boosted attention and mood, although participants were aware of psychedelic effects, prompting researchers to conclude the results demonstrated “selective, beneficial effects.”

“The majority of participants have improved attention,” study investigator Nadia Hutten, PhD, Department of Neuropsychology and Psychopharmacology, Maastricht University, the Netherlands, told Medscape Medical News.

“So we think that patients with attention deficits might have more beneficial effects,” she added, noting her team plans to study LSD microdosing in patients with attention deficit hyperactivity disorder.

The study was presented at the 33rd European College of Neuropsychopharmacology (ECNP) Congress, which was held online this year because of the COVID-19 pandemic.

Growing interest

Over the past 10 years there has been growing interest in psychedelic microdosing, which is defined as a dose that aims to enhance mood and/or performance but does not affect perception.

However, there has been considerable debate over what constitutes a “microdose.” One tenth of a “full” psychedelic dose is typically suggested, but users report a much wider dose range in practice, suggesting potential “individual variation in response to low doses,” the researchers note.

In the current dose-finding study, the researchers explored whether the effects of LSD on cognition and subjective measures differed between individuals.

The study included 24 healthy recreational drug users and compared the acute effects of 5 mcg, 20 mcg, and 20 mcg LSD with placebo on a computer-based psychomotor vigilance task (PVT) that measured attention and on a Digit Symbol Substitution Test (DSST).

Participants also completed the 72-item Profile of Mood States (POMS) questionnaire, a visual analog scale (VAS) on mood, and the 94-item 5-Dimensional Altered States of Consciousness Rating scales (5D-ASC).

Unadjusted results showed that the 20-mcg LSD dose significantly reduced correct substitutions on the DSST vs placebo (P < .05), but had no effect on attentional lapses on the PCT or on positive mood on the POMS.

Correcting the DSST score for the number of total responses revealed no dose effect of LSD. This suggested that participants were no less accurate when under the influence of LSD, even though they encoded fewer digits, the researchers note.

Participants also reported that both the 10-mcg and 20-mcg dose of LSD increased subjective experiences on the VAS and alternated states of consciousness on the 5D-ASC compared with placebo.

After stratifying the results by dose and participant, the effect of LSD differed between individuals. For example, both the 5-mcg and 20-mcg doses were associated with improvement in attention on the PVT (P < .05), but not the 10-mcg dose.

These results also indicated that the 20-mcg dose was associated with a significant increase in the correct number of substitutions on the DSST and with a significant increase in positive mood on the POMS (P < .05 for both outcomes).

The findings suggest that future studies in patient populations with impaired attention are needed, “including biological parameters involved in LSD receptor-binding and metabolism, in order to understand the inter-individual variation in response to LSD,” the investigators note.

In an educational session at the meeting, the study’s lead researcher, Kim Kuypers, PhD, associate professor at Maastricht University, said research shows individuals are already self-medicating with psychedelic microdosing to treat a wide range of mental health problems, and rated it as significantly more effective than conventional therapy at alleviating symptoms and improving quality of life.

Nevertheless, Kuypers noted there have been fewer than 20 published placebo-controlled studies examining psychedelic microdosing in humans – and much of the current evidence is anecdotal.

However, there is some clinical research suggesting that low-dose LSD is associated with improved mood and cognitive performance and that it also has an effect on resting-state amygdala functional connectivity and acutely increases brain-derived neurotrophic factor plasma levels.

Furthermore, said Kuypers, the evidence in healthy volunteers thus far suggests microdosing is “safe.”
 

Jumping ahead of the science?

Commenting on the study for Medscape Medical News, Jeffrey A. Lieberman, MD, professor and chair of psychiatry at Columbia University, New York City, said he “gives the investigators credit for doing such a study” but does not believe anything can be gleaned from the findings.

He said he is also concerned that the resurgence of psychedelic research is not congruent with “the methodologic rigor and scientific thinking that accompanies treatment development in other disease areas.”

Lieberman, who is also psychiatrist-in-chief at the NewYork–Presbyterian Hospital Columbia Medical Center and was not involved with the study, added that some of the research is also being conducted in individuals who are “true believers and not sufficiently dispassionate and objective.”

“If this was just a treatment . . . for some type of skin fungus, no one would pay any attention to it. But because these are such notorious and interesting compounds, they have attracted a lot of peripheral interest to promote and to disseminate; and the risk is that it will be done in the wrong way and there may be consequences,” he said.

Moreover, Lieberman noted that the psychedelic drugs may be used in practice ahead of strong evidence of safety and efficacy. As an example, he pointed to ketamine, a drug that was identified as a treatment for people with depression who had not responded to standard treatments, he noted.

“But before you knew it, there were clinics being opened up all over the place by anesthesiologists or other people that were trying to make a quick buck,” he said.

“That was alarming because they were stretching the criteria for whom the treatment was appropriate; there were no protocols for dosing, for frequency of administration, and there was inadequate psychiatric follow-up,” Lieberman added.
 

Preliminary but promising

He agreed with Kuypers that cases of microdosing with psychedelics are largely anecdotal.

“So in that context, when these investigators tried to put it to a test, which is commendable, the results in no way tell you whether it’s good, bad, or indifferent,” Lieberman said. In fact, the results are “disappointing in terms of suggesting any beneficial effect.”

Lieberman said more and larger studies are needed in order to determine whether LSD microdosing is beneficial. 

In response to Lieberman’s comments, Kuypers told Medscape Medical News that the investigators tried to base their placebo-controlled research on previous anecdotal research.

She emphasized that the “whole field is still in its infancy,” including research on the use of “full” doses of psychedelics.

“I sometimes think that the message is too positive. We should never forget to communicate that not a lot of research has been done.” In addition, she agreed that researchers should “keep a balanced message.”

“All the data to date is preliminary, in my view, but promising,” she stressed, “and the evidence is growing.”

The study received financial support from the Beckley Foundation. The study authors and Lieberman have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Microdosing with lysergic acid diethylamide (LSD) is associated with improved mood and increased attention, early research suggests. However, at least one expert believes it’s far too soon to tell and warns against endorsing patient microdosing.

In a dose-finding exploratory study, three low doses of LSD were compared with placebo in healthy volunteers who were all recreational drug users. Adjusted results showed that the highest dose boosted attention and mood, although participants were aware of psychedelic effects, prompting researchers to conclude the results demonstrated “selective, beneficial effects.”

“The majority of participants have improved attention,” study investigator Nadia Hutten, PhD, Department of Neuropsychology and Psychopharmacology, Maastricht University, the Netherlands, told Medscape Medical News.

“So we think that patients with attention deficits might have more beneficial effects,” she added, noting her team plans to study LSD microdosing in patients with attention deficit hyperactivity disorder.

The study was presented at the 33rd European College of Neuropsychopharmacology (ECNP) Congress, which was held online this year because of the COVID-19 pandemic.

Growing interest

Over the past 10 years there has been growing interest in psychedelic microdosing, which is defined as a dose that aims to enhance mood and/or performance but does not affect perception.

However, there has been considerable debate over what constitutes a “microdose.” One tenth of a “full” psychedelic dose is typically suggested, but users report a much wider dose range in practice, suggesting potential “individual variation in response to low doses,” the researchers note.

In the current dose-finding study, the researchers explored whether the effects of LSD on cognition and subjective measures differed between individuals.

The study included 24 healthy recreational drug users and compared the acute effects of 5 mcg, 20 mcg, and 20 mcg LSD with placebo on a computer-based psychomotor vigilance task (PVT) that measured attention and on a Digit Symbol Substitution Test (DSST).

Participants also completed the 72-item Profile of Mood States (POMS) questionnaire, a visual analog scale (VAS) on mood, and the 94-item 5-Dimensional Altered States of Consciousness Rating scales (5D-ASC).

Unadjusted results showed that the 20-mcg LSD dose significantly reduced correct substitutions on the DSST vs placebo (P < .05), but had no effect on attentional lapses on the PCT or on positive mood on the POMS.

Correcting the DSST score for the number of total responses revealed no dose effect of LSD. This suggested that participants were no less accurate when under the influence of LSD, even though they encoded fewer digits, the researchers note.

Participants also reported that both the 10-mcg and 20-mcg dose of LSD increased subjective experiences on the VAS and alternated states of consciousness on the 5D-ASC compared with placebo.

After stratifying the results by dose and participant, the effect of LSD differed between individuals. For example, both the 5-mcg and 20-mcg doses were associated with improvement in attention on the PVT (P < .05), but not the 10-mcg dose.

These results also indicated that the 20-mcg dose was associated with a significant increase in the correct number of substitutions on the DSST and with a significant increase in positive mood on the POMS (P < .05 for both outcomes).

The findings suggest that future studies in patient populations with impaired attention are needed, “including biological parameters involved in LSD receptor-binding and metabolism, in order to understand the inter-individual variation in response to LSD,” the investigators note.

In an educational session at the meeting, the study’s lead researcher, Kim Kuypers, PhD, associate professor at Maastricht University, said research shows individuals are already self-medicating with psychedelic microdosing to treat a wide range of mental health problems, and rated it as significantly more effective than conventional therapy at alleviating symptoms and improving quality of life.

Nevertheless, Kuypers noted there have been fewer than 20 published placebo-controlled studies examining psychedelic microdosing in humans – and much of the current evidence is anecdotal.

However, there is some clinical research suggesting that low-dose LSD is associated with improved mood and cognitive performance and that it also has an effect on resting-state amygdala functional connectivity and acutely increases brain-derived neurotrophic factor plasma levels.

Furthermore, said Kuypers, the evidence in healthy volunteers thus far suggests microdosing is “safe.”
 

Jumping ahead of the science?

Commenting on the study for Medscape Medical News, Jeffrey A. Lieberman, MD, professor and chair of psychiatry at Columbia University, New York City, said he “gives the investigators credit for doing such a study” but does not believe anything can be gleaned from the findings.

He said he is also concerned that the resurgence of psychedelic research is not congruent with “the methodologic rigor and scientific thinking that accompanies treatment development in other disease areas.”

Lieberman, who is also psychiatrist-in-chief at the NewYork–Presbyterian Hospital Columbia Medical Center and was not involved with the study, added that some of the research is also being conducted in individuals who are “true believers and not sufficiently dispassionate and objective.”

“If this was just a treatment . . . for some type of skin fungus, no one would pay any attention to it. But because these are such notorious and interesting compounds, they have attracted a lot of peripheral interest to promote and to disseminate; and the risk is that it will be done in the wrong way and there may be consequences,” he said.

Moreover, Lieberman noted that the psychedelic drugs may be used in practice ahead of strong evidence of safety and efficacy. As an example, he pointed to ketamine, a drug that was identified as a treatment for people with depression who had not responded to standard treatments, he noted.

“But before you knew it, there were clinics being opened up all over the place by anesthesiologists or other people that were trying to make a quick buck,” he said.

“That was alarming because they were stretching the criteria for whom the treatment was appropriate; there were no protocols for dosing, for frequency of administration, and there was inadequate psychiatric follow-up,” Lieberman added.
 

Preliminary but promising

He agreed with Kuypers that cases of microdosing with psychedelics are largely anecdotal.

“So in that context, when these investigators tried to put it to a test, which is commendable, the results in no way tell you whether it’s good, bad, or indifferent,” Lieberman said. In fact, the results are “disappointing in terms of suggesting any beneficial effect.”

Lieberman said more and larger studies are needed in order to determine whether LSD microdosing is beneficial. 

In response to Lieberman’s comments, Kuypers told Medscape Medical News that the investigators tried to base their placebo-controlled research on previous anecdotal research.

She emphasized that the “whole field is still in its infancy,” including research on the use of “full” doses of psychedelics.

“I sometimes think that the message is too positive. We should never forget to communicate that not a lot of research has been done.” In addition, she agreed that researchers should “keep a balanced message.”

“All the data to date is preliminary, in my view, but promising,” she stressed, “and the evidence is growing.”

The study received financial support from the Beckley Foundation. The study authors and Lieberman have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

“I worry that vaccines are going to be sold like magic powder that we sprinkle across the land and make the virus go away,” Paul Offit, MD, said at the virtual American Academy of Pediatrics (AAP) 2020 National Conference. “That’s not true.”

Even after effective vaccines for SARS-CoV-2 are in widespread use, wearing masks will still be advisable to prevent COVID-19, according to Dr. Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

“I think we can get a vaccine that’s 75%-80% effective at preventing mild to moderate disease, but that means one of every four people can still get moderate to severe disease,” Dr. Offit continued.

And that’s if there is high uptake of the vaccine, which may not be the case. Recent polls have suggested there is considerable concern about the pending vaccines.

“It’s somewhat understandable,” Dr. Offitt acknowledged, especially given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. Before COVID-19, the fastest vaccine ever developed was for mumps, he said, with the virus isolated in 1963 and a commercial product available in 1967.
 

Addressing hesitancy in clinics

In a wide-ranging livestream plenary presentation, Dr. Offit, coinventor of a rotavirus vaccine, shed light on SARS-CoV-2 vaccine development and his impressions of vaccine hesitancy among patients and families. He also offered advice for how to reassure those skeptical of the safety and efficacy of any SARS-COV-2 vaccine, given the accelerated development process.

With more than 180 different vaccines in various stages of investigation, Dr. Offit called the effort to develop COVID-19 vaccines “unprecedented.” Part of that is a result of governments relieving pharmaceutical companies of much of the typical financial risk – which often climbs to hundreds of millions of dollars – by underwriting the costs of vaccine development to battle the pandemic-inducing virus, he said.

But this very swiftness is also stoking antivaccine sentiment. Dr. Offit, part of vaccine advisory groups for the National Institutes of Health and U.S. Food and Drug Administration, cited recent research reporting nearly half of American adults definitely or probably would not get a COVID-19 vaccine if it were available today.

“One way you convince skeptics is with data presented in a clear, compassionate, and compelling way,” he said.

“The other group is vaccine cynics, who are basically conspiracy theorists who believe pharmaceutical companies control the world, the government, the medical establishment. I think there’s no talking them down from this.”

Numerous strategies are being used in COVID-19 vaccine development, he noted, including messenger RNA, DNA, viral vectors, purified protein, and whole killed virus. Dr. Offit believes any candidates approved for distribution will likely be in the range of 75% effective at preventing mild to moderate symptoms.

But clinicians should be ready to face immediate questions of safety. “Even if this vaccination is given to 20,000 [trial participants] safely, that’s not 20 million,” Dr. Offit said. “Anyone could reasonably ask questions about if it causes rare, serious side effects.

“The good news is, there are systems in place,” such as adverse event reporting systems, to identify rare events, even those that occur in one in a million vaccine recipients. Reminding patients of that continued surveillance can be reassuring.

Another reassuring point is that COVID-19 vaccine trial participants have included people from many diverse populations, he said. But children, notably absent so far, should be added to trials immediately, Dr. Offit contends.

“This is going to be important when you consider strategies to get children universally back into school,” he said, which is a “critical issue” from both learning and wellness standpoints. “It breaks my heart that we’ve been unable to do this when other countries have.”
 

Transparency will be paramount

While presenting data transparently to patients is key in helping them accept COVID-19 vaccination, Dr. Offit said, he also believes “telling stories” can be just as effective, if not more so. When the varicella vaccine was approved in 1995, he said, the “uptake the first few years was pretty miserable” until public service messaging emphasized that some children die from chickenpox.

“Fear works,” he said. “You always worry about pushback of something being oversold, but hopefully we’re scared enough about this virus” to convince people that vaccination is wise. “I do think personal stories carry weight on both sides,” Dr. Offit said.

Mark Sawyer, MD, of University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, California, said Offit’s presentation offered important takeaways for clinicians about how to broach the topic of COVID-19 vaccination with patients and families.

“We need to communicate clearly and transparently to patients about what we do and don’t know” about the vaccines, Dr. Sawyer said in an interview. “We will know if they have common side effects, but we will not know about very rare side effects until we have used the vaccines for a while.

“We will know how well the vaccine works over the short-term, but we won’t know over the long term,” added Dr. Sawyer, a member of the AAP Committee on Infectious Diseases.

“We can reassure the community that SARS-CoV-2 vaccines are being evaluated in trials in the same way and with the same thoroughness as other vaccines have been,” he said. “That should give people confidence that shortcuts are not being taken with regard to safety and effectiveness evaluations.”

Dr. Offit and Dr. Sawyer have disclosed no relevant financial relationships.
 

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

“I worry that vaccines are going to be sold like magic powder that we sprinkle across the land and make the virus go away,” Paul Offit, MD, said at the virtual American Academy of Pediatrics (AAP) 2020 National Conference. “That’s not true.”

Even after effective vaccines for SARS-CoV-2 are in widespread use, wearing masks will still be advisable to prevent COVID-19, according to Dr. Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

“I think we can get a vaccine that’s 75%-80% effective at preventing mild to moderate disease, but that means one of every four people can still get moderate to severe disease,” Dr. Offit continued.

And that’s if there is high uptake of the vaccine, which may not be the case. Recent polls have suggested there is considerable concern about the pending vaccines.

“It’s somewhat understandable,” Dr. Offitt acknowledged, especially given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. Before COVID-19, the fastest vaccine ever developed was for mumps, he said, with the virus isolated in 1963 and a commercial product available in 1967.
 

Addressing hesitancy in clinics

In a wide-ranging livestream plenary presentation, Dr. Offit, coinventor of a rotavirus vaccine, shed light on SARS-CoV-2 vaccine development and his impressions of vaccine hesitancy among patients and families. He also offered advice for how to reassure those skeptical of the safety and efficacy of any SARS-COV-2 vaccine, given the accelerated development process.

With more than 180 different vaccines in various stages of investigation, Dr. Offit called the effort to develop COVID-19 vaccines “unprecedented.” Part of that is a result of governments relieving pharmaceutical companies of much of the typical financial risk – which often climbs to hundreds of millions of dollars – by underwriting the costs of vaccine development to battle the pandemic-inducing virus, he said.

But this very swiftness is also stoking antivaccine sentiment. Dr. Offit, part of vaccine advisory groups for the National Institutes of Health and U.S. Food and Drug Administration, cited recent research reporting nearly half of American adults definitely or probably would not get a COVID-19 vaccine if it were available today.

“One way you convince skeptics is with data presented in a clear, compassionate, and compelling way,” he said.

“The other group is vaccine cynics, who are basically conspiracy theorists who believe pharmaceutical companies control the world, the government, the medical establishment. I think there’s no talking them down from this.”

Numerous strategies are being used in COVID-19 vaccine development, he noted, including messenger RNA, DNA, viral vectors, purified protein, and whole killed virus. Dr. Offit believes any candidates approved for distribution will likely be in the range of 75% effective at preventing mild to moderate symptoms.

But clinicians should be ready to face immediate questions of safety. “Even if this vaccination is given to 20,000 [trial participants] safely, that’s not 20 million,” Dr. Offit said. “Anyone could reasonably ask questions about if it causes rare, serious side effects.

“The good news is, there are systems in place,” such as adverse event reporting systems, to identify rare events, even those that occur in one in a million vaccine recipients. Reminding patients of that continued surveillance can be reassuring.

Another reassuring point is that COVID-19 vaccine trial participants have included people from many diverse populations, he said. But children, notably absent so far, should be added to trials immediately, Dr. Offit contends.

“This is going to be important when you consider strategies to get children universally back into school,” he said, which is a “critical issue” from both learning and wellness standpoints. “It breaks my heart that we’ve been unable to do this when other countries have.”
 

Transparency will be paramount

While presenting data transparently to patients is key in helping them accept COVID-19 vaccination, Dr. Offit said, he also believes “telling stories” can be just as effective, if not more so. When the varicella vaccine was approved in 1995, he said, the “uptake the first few years was pretty miserable” until public service messaging emphasized that some children die from chickenpox.

“Fear works,” he said. “You always worry about pushback of something being oversold, but hopefully we’re scared enough about this virus” to convince people that vaccination is wise. “I do think personal stories carry weight on both sides,” Dr. Offit said.

Mark Sawyer, MD, of University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, California, said Offit’s presentation offered important takeaways for clinicians about how to broach the topic of COVID-19 vaccination with patients and families.

“We need to communicate clearly and transparently to patients about what we do and don’t know” about the vaccines, Dr. Sawyer said in an interview. “We will know if they have common side effects, but we will not know about very rare side effects until we have used the vaccines for a while.

“We will know how well the vaccine works over the short-term, but we won’t know over the long term,” added Dr. Sawyer, a member of the AAP Committee on Infectious Diseases.

“We can reassure the community that SARS-CoV-2 vaccines are being evaluated in trials in the same way and with the same thoroughness as other vaccines have been,” he said. “That should give people confidence that shortcuts are not being taken with regard to safety and effectiveness evaluations.”

Dr. Offit and Dr. Sawyer have disclosed no relevant financial relationships.
 

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

“I worry that vaccines are going to be sold like magic powder that we sprinkle across the land and make the virus go away,” Paul Offit, MD, said at the virtual American Academy of Pediatrics (AAP) 2020 National Conference. “That’s not true.”

Even after effective vaccines for SARS-CoV-2 are in widespread use, wearing masks will still be advisable to prevent COVID-19, according to Dr. Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

“I think we can get a vaccine that’s 75%-80% effective at preventing mild to moderate disease, but that means one of every four people can still get moderate to severe disease,” Dr. Offit continued.

And that’s if there is high uptake of the vaccine, which may not be the case. Recent polls have suggested there is considerable concern about the pending vaccines.

“It’s somewhat understandable,” Dr. Offitt acknowledged, especially given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. Before COVID-19, the fastest vaccine ever developed was for mumps, he said, with the virus isolated in 1963 and a commercial product available in 1967.
 

Addressing hesitancy in clinics

In a wide-ranging livestream plenary presentation, Dr. Offit, coinventor of a rotavirus vaccine, shed light on SARS-CoV-2 vaccine development and his impressions of vaccine hesitancy among patients and families. He also offered advice for how to reassure those skeptical of the safety and efficacy of any SARS-COV-2 vaccine, given the accelerated development process.

With more than 180 different vaccines in various stages of investigation, Dr. Offit called the effort to develop COVID-19 vaccines “unprecedented.” Part of that is a result of governments relieving pharmaceutical companies of much of the typical financial risk – which often climbs to hundreds of millions of dollars – by underwriting the costs of vaccine development to battle the pandemic-inducing virus, he said.

But this very swiftness is also stoking antivaccine sentiment. Dr. Offit, part of vaccine advisory groups for the National Institutes of Health and U.S. Food and Drug Administration, cited recent research reporting nearly half of American adults definitely or probably would not get a COVID-19 vaccine if it were available today.

“One way you convince skeptics is with data presented in a clear, compassionate, and compelling way,” he said.

“The other group is vaccine cynics, who are basically conspiracy theorists who believe pharmaceutical companies control the world, the government, the medical establishment. I think there’s no talking them down from this.”

Numerous strategies are being used in COVID-19 vaccine development, he noted, including messenger RNA, DNA, viral vectors, purified protein, and whole killed virus. Dr. Offit believes any candidates approved for distribution will likely be in the range of 75% effective at preventing mild to moderate symptoms.

But clinicians should be ready to face immediate questions of safety. “Even if this vaccination is given to 20,000 [trial participants] safely, that’s not 20 million,” Dr. Offit said. “Anyone could reasonably ask questions about if it causes rare, serious side effects.

“The good news is, there are systems in place,” such as adverse event reporting systems, to identify rare events, even those that occur in one in a million vaccine recipients. Reminding patients of that continued surveillance can be reassuring.

Another reassuring point is that COVID-19 vaccine trial participants have included people from many diverse populations, he said. But children, notably absent so far, should be added to trials immediately, Dr. Offit contends.

“This is going to be important when you consider strategies to get children universally back into school,” he said, which is a “critical issue” from both learning and wellness standpoints. “It breaks my heart that we’ve been unable to do this when other countries have.”
 

Transparency will be paramount

While presenting data transparently to patients is key in helping them accept COVID-19 vaccination, Dr. Offit said, he also believes “telling stories” can be just as effective, if not more so. When the varicella vaccine was approved in 1995, he said, the “uptake the first few years was pretty miserable” until public service messaging emphasized that some children die from chickenpox.

“Fear works,” he said. “You always worry about pushback of something being oversold, but hopefully we’re scared enough about this virus” to convince people that vaccination is wise. “I do think personal stories carry weight on both sides,” Dr. Offit said.

Mark Sawyer, MD, of University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, California, said Offit’s presentation offered important takeaways for clinicians about how to broach the topic of COVID-19 vaccination with patients and families.

“We need to communicate clearly and transparently to patients about what we do and don’t know” about the vaccines, Dr. Sawyer said in an interview. “We will know if they have common side effects, but we will not know about very rare side effects until we have used the vaccines for a while.

“We will know how well the vaccine works over the short-term, but we won’t know over the long term,” added Dr. Sawyer, a member of the AAP Committee on Infectious Diseases.

“We can reassure the community that SARS-CoV-2 vaccines are being evaluated in trials in the same way and with the same thoroughness as other vaccines have been,” he said. “That should give people confidence that shortcuts are not being taken with regard to safety and effectiveness evaluations.”

Dr. Offit and Dr. Sawyer have disclosed no relevant financial relationships.
 

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