Pediatric News

In August I shared with you my observations on two opposing op-ed pieces from two major newspapers, one was in favor of masking mandates for public schools, the other against. (Masking in school: A battle of the op-eds. MDedge Pediatrics. Letters from Maine, 2021 Aug 12). Neither group of authors could offer us evidence from controlled studies to support their views. However, both agreed that returning children to school deserves a high priority. But neither the authors nor I treaded into the uncharted waters of exactly how masking fits into our national goals for managing the pandemic because ... no one in this country has articulated what these goals should be. A third op-ed appearing 3 weeks later suggests why we are floundering in this goal-deficient limbo.

Writing in the New York Times, two epidemiologists in Boston ask the simple question: “What are we actually trying to achieve in the United States?” when it comes to the pandemic. (Allen AG and Jenkins H. The Hard Covid-19 Questions We’re Not Asking. 2021 Aug 30). Is our goal zero infections? Is it hammering on the virus until we can treat it like the seasonal flu? We do seem to agree that not having kids in school has been a disaster economically, educationally, and psychologically. But, where does the goal of getting them back in school fit into a larger and as yet undefined national goal? Without that target we have little idea of what compromises and risks we should be willing to accept.

How much serious pediatric disease is acceptable? It appears that the number of fatal complications in the pediatric population is very small in comparison with other demographic groups. Although few in number, there have been and there will continue to be pediatric deaths because of COVID. Is our goal zero pediatric deaths? If it is then this dictates a level of response that ripples back upstream to every child in every classroom and could threaten our overarching goal of returning children to school. Because none of us likes the thought of a child dying, some of us may be hesitant to even consider a strategy that doesn’t include zero pediatric deaths as a goal.

Are we looking to have zero serious pediatric infections? Achieving this goal is unlikely. Even if we develop a pediatric vaccine in the near future it probably won’t be in the arms of enough children by the end of this school year to make a significant dent in the number of serious pediatric infections. Waiting until an optimal number of children are immunized doesn’t feel like it will achieve a primary goal of getting kids back in school if we continue to focus on driving the level of serious pediatric infections to zero. We have already endured a year in which many communities made decisions that seemed to have prioritized an unstated goal of no school exposure–related educator deaths. Again, a goal based on little if any evidence.

The problem we face in this country is that our response to the pandemic has been nonuniform. Here in Brunswick, Maine, 99% of the eligible adults have been vaccinated. Even with the recent surge, we may be ready for a strategy that avoids wholesale quarantining. A targeted and robust antibody testing system might work for us and make an unproven and unpopular masking mandate unnecessary. Britain seems to be moving in a similar direction to meet its goal of keeping children in school.

However, there are large population groups in regions of this country that have stumbled at taking the initial steps to get the pandemic under control. Articulating a national goal that covers both communities where the response to the pandemic has been less thoughtful and robust along with states that have been more successful is going to be difficult. But it must be done.

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].

In August I shared with you my observations on two opposing op-ed pieces from two major newspapers, one was in favor of masking mandates for public schools, the other against. (Masking in school: A battle of the op-eds. MDedge Pediatrics. Letters from Maine, 2021 Aug 12). Neither group of authors could offer us evidence from controlled studies to support their views. However, both agreed that returning children to school deserves a high priority. But neither the authors nor I treaded into the uncharted waters of exactly how masking fits into our national goals for managing the pandemic because ... no one in this country has articulated what these goals should be. A third op-ed appearing 3 weeks later suggests why we are floundering in this goal-deficient limbo.

Writing in the New York Times, two epidemiologists in Boston ask the simple question: “What are we actually trying to achieve in the United States?” when it comes to the pandemic. (Allen AG and Jenkins H. The Hard Covid-19 Questions We’re Not Asking. 2021 Aug 30). Is our goal zero infections? Is it hammering on the virus until we can treat it like the seasonal flu? We do seem to agree that not having kids in school has been a disaster economically, educationally, and psychologically. But, where does the goal of getting them back in school fit into a larger and as yet undefined national goal? Without that target we have little idea of what compromises and risks we should be willing to accept.

How much serious pediatric disease is acceptable? It appears that the number of fatal complications in the pediatric population is very small in comparison with other demographic groups. Although few in number, there have been and there will continue to be pediatric deaths because of COVID. Is our goal zero pediatric deaths? If it is then this dictates a level of response that ripples back upstream to every child in every classroom and could threaten our overarching goal of returning children to school. Because none of us likes the thought of a child dying, some of us may be hesitant to even consider a strategy that doesn’t include zero pediatric deaths as a goal.

Are we looking to have zero serious pediatric infections? Achieving this goal is unlikely. Even if we develop a pediatric vaccine in the near future it probably won’t be in the arms of enough children by the end of this school year to make a significant dent in the number of serious pediatric infections. Waiting until an optimal number of children are immunized doesn’t feel like it will achieve a primary goal of getting kids back in school if we continue to focus on driving the level of serious pediatric infections to zero. We have already endured a year in which many communities made decisions that seemed to have prioritized an unstated goal of no school exposure–related educator deaths. Again, a goal based on little if any evidence.

The problem we face in this country is that our response to the pandemic has been nonuniform. Here in Brunswick, Maine, 99% of the eligible adults have been vaccinated. Even with the recent surge, we may be ready for a strategy that avoids wholesale quarantining. A targeted and robust antibody testing system might work for us and make an unproven and unpopular masking mandate unnecessary. Britain seems to be moving in a similar direction to meet its goal of keeping children in school.

However, there are large population groups in regions of this country that have stumbled at taking the initial steps to get the pandemic under control. Articulating a national goal that covers both communities where the response to the pandemic has been less thoughtful and robust along with states that have been more successful is going to be difficult. But it must be done.

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].

In August I shared with you my observations on two opposing op-ed pieces from two major newspapers, one was in favor of masking mandates for public schools, the other against. (Masking in school: A battle of the op-eds. MDedge Pediatrics. Letters from Maine, 2021 Aug 12). Neither group of authors could offer us evidence from controlled studies to support their views. However, both agreed that returning children to school deserves a high priority. But neither the authors nor I treaded into the uncharted waters of exactly how masking fits into our national goals for managing the pandemic because ... no one in this country has articulated what these goals should be. A third op-ed appearing 3 weeks later suggests why we are floundering in this goal-deficient limbo.

Writing in the New York Times, two epidemiologists in Boston ask the simple question: “What are we actually trying to achieve in the United States?” when it comes to the pandemic. (Allen AG and Jenkins H. The Hard Covid-19 Questions We’re Not Asking. 2021 Aug 30). Is our goal zero infections? Is it hammering on the virus until we can treat it like the seasonal flu? We do seem to agree that not having kids in school has been a disaster economically, educationally, and psychologically. But, where does the goal of getting them back in school fit into a larger and as yet undefined national goal? Without that target we have little idea of what compromises and risks we should be willing to accept.

How much serious pediatric disease is acceptable? It appears that the number of fatal complications in the pediatric population is very small in comparison with other demographic groups. Although few in number, there have been and there will continue to be pediatric deaths because of COVID. Is our goal zero pediatric deaths? If it is then this dictates a level of response that ripples back upstream to every child in every classroom and could threaten our overarching goal of returning children to school. Because none of us likes the thought of a child dying, some of us may be hesitant to even consider a strategy that doesn’t include zero pediatric deaths as a goal.

Are we looking to have zero serious pediatric infections? Achieving this goal is unlikely. Even if we develop a pediatric vaccine in the near future it probably won’t be in the arms of enough children by the end of this school year to make a significant dent in the number of serious pediatric infections. Waiting until an optimal number of children are immunized doesn’t feel like it will achieve a primary goal of getting kids back in school if we continue to focus on driving the level of serious pediatric infections to zero. We have already endured a year in which many communities made decisions that seemed to have prioritized an unstated goal of no school exposure–related educator deaths. Again, a goal based on little if any evidence.

The problem we face in this country is that our response to the pandemic has been nonuniform. Here in Brunswick, Maine, 99% of the eligible adults have been vaccinated. Even with the recent surge, we may be ready for a strategy that avoids wholesale quarantining. A targeted and robust antibody testing system might work for us and make an unproven and unpopular masking mandate unnecessary. Britain seems to be moving in a similar direction to meet its goal of keeping children in school.

However, there are large population groups in regions of this country that have stumbled at taking the initial steps to get the pandemic under control. Articulating a national goal that covers both communities where the response to the pandemic has been less thoughtful and robust along with states that have been more successful is going to be difficult. But it must be done.

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].

As private practices try to recover and rebuild in the wake of the COVID-19 pandemic, many have faced an unexpected challenge: a paucity of employees.

My own office is prime example: I have had job listings for both front- and back-office positions posted on all the major job boards and other employment portals for months, with a disappointing response. Of the few who do respond, many, incredibly, do not show up for their interviews!

It turns out that this is a widespread problem, and not just in medicine. A recent survey by the National Federation of Independent Business found that 42% of business owners, in all walks of life, had job openings that could not be filled, a record high. Over 90% of those hiring reported few or no qualified applicants and an increase in interview no-shows.

Clearly, this is a huge obstacle to growth – and even to conducting normal operations – for my practice and many others.

Reasons for the situation vary, but a big one has been the unfortunate fact that many open job positions actually pay less than the expanded unemployment benefits that many people have received under the March 2020 CARES Act. By one estimate, almost 70% of unemployed workers have been collecting more on unemployment than they earned while working. The CARES benefits expired in early September, but many potential workers continue to receive payments through a newer FEMA program, and some states have their own ongoing benefit programs.

Other reasons have been offered: Some candidates are unvaccinated (an immediate deal-breaker in my office), and some working parents continue to face a lack of childcare or in-person schooling for their children. Some applicants – regardless of vaccination status – have said they are hesitant to work in a medical office setting and risk getting COVID-19, despite all the precautions we have in place. Others have said they are waiting until the job market improves.

There are no easy solutions to this complicated problem, but here are a few suggestions culled from my research and conversations with HR professionals and others.

One obvious option is to offer higher wages, and perhaps even signing bonuses. “Whenever anyone says they can’t find the workers they need,” a consultant told me, “they are really saying they can’t find them at the wages they want to pay.” There are limits to the wages and benefits a private office with a very finite salary budget can offer, of course – but a few higher-paid employees may be preferable to no new workers at all.

For job candidates who fear COVID-19 exposure, assure them that their health and safety is a priority by spelling out the procedures your office is following (social distancing, reduced patient capacity, interaction barriers, face masks, avoidance of handshakes, enhanced cleaning procedures, symptom questionnaires, temperature checks, etc.) to minimize the risk of exposure.

You also may need to rework your interview process. In the Zoom era, most preliminary interviews can be conducted remotely. For on-site interviews, explain how you’re maintaining a safe interview environment by applying the same office safety policies to interactions with interviewees.

If a promising candidate doesn’t show up for an interview, the applicant could be making a token effort to obtain a job in order to perpetuate unemployment payments, but don’t jump to that conclusion. There may be extenuating circumstances, such as an emergency, illness, or traffic issues. Also, consider the possibility that it was your fault. If you waited too long to schedule the interview, another office could have lured them away. Or you may not have adequately explained your COVID-19 exposure safeguards. At the very least, a drawn-out process or a lack of transparency can make applicants apprehensive about accepting a job with you, particularly if other employers are pursuing them.

To counter the shortsighted appeal of collecting unemployment benefits, it may help to highlight the long-term growth opportunities available at your office. Consider outlining typical career tracks, or providing specific examples of how people have advanced their careers at your facility. I frequently cite the example of my current office manager, who began as an assistant receptionist almost 30 years ago.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

As private practices try to recover and rebuild in the wake of the COVID-19 pandemic, many have faced an unexpected challenge: a paucity of employees.

My own office is prime example: I have had job listings for both front- and back-office positions posted on all the major job boards and other employment portals for months, with a disappointing response. Of the few who do respond, many, incredibly, do not show up for their interviews!

It turns out that this is a widespread problem, and not just in medicine. A recent survey by the National Federation of Independent Business found that 42% of business owners, in all walks of life, had job openings that could not be filled, a record high. Over 90% of those hiring reported few or no qualified applicants and an increase in interview no-shows.

Clearly, this is a huge obstacle to growth – and even to conducting normal operations – for my practice and many others.

Reasons for the situation vary, but a big one has been the unfortunate fact that many open job positions actually pay less than the expanded unemployment benefits that many people have received under the March 2020 CARES Act. By one estimate, almost 70% of unemployed workers have been collecting more on unemployment than they earned while working. The CARES benefits expired in early September, but many potential workers continue to receive payments through a newer FEMA program, and some states have their own ongoing benefit programs.

Other reasons have been offered: Some candidates are unvaccinated (an immediate deal-breaker in my office), and some working parents continue to face a lack of childcare or in-person schooling for their children. Some applicants – regardless of vaccination status – have said they are hesitant to work in a medical office setting and risk getting COVID-19, despite all the precautions we have in place. Others have said they are waiting until the job market improves.

There are no easy solutions to this complicated problem, but here are a few suggestions culled from my research and conversations with HR professionals and others.

One obvious option is to offer higher wages, and perhaps even signing bonuses. “Whenever anyone says they can’t find the workers they need,” a consultant told me, “they are really saying they can’t find them at the wages they want to pay.” There are limits to the wages and benefits a private office with a very finite salary budget can offer, of course – but a few higher-paid employees may be preferable to no new workers at all.

For job candidates who fear COVID-19 exposure, assure them that their health and safety is a priority by spelling out the procedures your office is following (social distancing, reduced patient capacity, interaction barriers, face masks, avoidance of handshakes, enhanced cleaning procedures, symptom questionnaires, temperature checks, etc.) to minimize the risk of exposure.

You also may need to rework your interview process. In the Zoom era, most preliminary interviews can be conducted remotely. For on-site interviews, explain how you’re maintaining a safe interview environment by applying the same office safety policies to interactions with interviewees.

If a promising candidate doesn’t show up for an interview, the applicant could be making a token effort to obtain a job in order to perpetuate unemployment payments, but don’t jump to that conclusion. There may be extenuating circumstances, such as an emergency, illness, or traffic issues. Also, consider the possibility that it was your fault. If you waited too long to schedule the interview, another office could have lured them away. Or you may not have adequately explained your COVID-19 exposure safeguards. At the very least, a drawn-out process or a lack of transparency can make applicants apprehensive about accepting a job with you, particularly if other employers are pursuing them.

To counter the shortsighted appeal of collecting unemployment benefits, it may help to highlight the long-term growth opportunities available at your office. Consider outlining typical career tracks, or providing specific examples of how people have advanced their careers at your facility. I frequently cite the example of my current office manager, who began as an assistant receptionist almost 30 years ago.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

As private practices try to recover and rebuild in the wake of the COVID-19 pandemic, many have faced an unexpected challenge: a paucity of employees.

My own office is prime example: I have had job listings for both front- and back-office positions posted on all the major job boards and other employment portals for months, with a disappointing response. Of the few who do respond, many, incredibly, do not show up for their interviews!

It turns out that this is a widespread problem, and not just in medicine. A recent survey by the National Federation of Independent Business found that 42% of business owners, in all walks of life, had job openings that could not be filled, a record high. Over 90% of those hiring reported few or no qualified applicants and an increase in interview no-shows.

Clearly, this is a huge obstacle to growth – and even to conducting normal operations – for my practice and many others.

Reasons for the situation vary, but a big one has been the unfortunate fact that many open job positions actually pay less than the expanded unemployment benefits that many people have received under the March 2020 CARES Act. By one estimate, almost 70% of unemployed workers have been collecting more on unemployment than they earned while working. The CARES benefits expired in early September, but many potential workers continue to receive payments through a newer FEMA program, and some states have their own ongoing benefit programs.

Other reasons have been offered: Some candidates are unvaccinated (an immediate deal-breaker in my office), and some working parents continue to face a lack of childcare or in-person schooling for their children. Some applicants – regardless of vaccination status – have said they are hesitant to work in a medical office setting and risk getting COVID-19, despite all the precautions we have in place. Others have said they are waiting until the job market improves.

There are no easy solutions to this complicated problem, but here are a few suggestions culled from my research and conversations with HR professionals and others.

One obvious option is to offer higher wages, and perhaps even signing bonuses. “Whenever anyone says they can’t find the workers they need,” a consultant told me, “they are really saying they can’t find them at the wages they want to pay.” There are limits to the wages and benefits a private office with a very finite salary budget can offer, of course – but a few higher-paid employees may be preferable to no new workers at all.

For job candidates who fear COVID-19 exposure, assure them that their health and safety is a priority by spelling out the procedures your office is following (social distancing, reduced patient capacity, interaction barriers, face masks, avoidance of handshakes, enhanced cleaning procedures, symptom questionnaires, temperature checks, etc.) to minimize the risk of exposure.

You also may need to rework your interview process. In the Zoom era, most preliminary interviews can be conducted remotely. For on-site interviews, explain how you’re maintaining a safe interview environment by applying the same office safety policies to interactions with interviewees.

If a promising candidate doesn’t show up for an interview, the applicant could be making a token effort to obtain a job in order to perpetuate unemployment payments, but don’t jump to that conclusion. There may be extenuating circumstances, such as an emergency, illness, or traffic issues. Also, consider the possibility that it was your fault. If you waited too long to schedule the interview, another office could have lured them away. Or you may not have adequately explained your COVID-19 exposure safeguards. At the very least, a drawn-out process or a lack of transparency can make applicants apprehensive about accepting a job with you, particularly if other employers are pursuing them.

To counter the shortsighted appeal of collecting unemployment benefits, it may help to highlight the long-term growth opportunities available at your office. Consider outlining typical career tracks, or providing specific examples of how people have advanced their careers at your facility. I frequently cite the example of my current office manager, who began as an assistant receptionist almost 30 years ago.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

If you haven’t noticed yet, there has been an explosion of new online companies specializing in slicing off some little sliver of health care and leaving traditional medicine to take care of the rest of the patient. Lately, many of these startups involve mental health care, traditionally a difficult area to make profitable unless one caters just to the wealthy. Many pediatricians have been unsure exactly what to make of these new efforts. Are these the rescuers we’ve been waiting for to fill what seems like an enormous and growing unmet need? Are they just another means to extract money from desperate people and leave the real work to someone else? Something in-between? This article outlines some points to consider when evaluating this new frontier.

Case vignette

A 12-year-old girl presents with her parents for an annual exam. She has been struggling with her mood and anxiety over the past 2 years along with occasional superficial cutting. You have started treatment with a selective serotonin reuptake inhibitor and have recommended that she see a mental health professional but the parents report that one attempt with a therapist was a poor fit and nobody in the area seems to be accepting new patients. The parents state that they saw an advertisement on TV for a company that offers online psychotherapy by video appointments or text. They think this might be an option to pursue but are a little skeptical of the whole idea. They look for your opinion on this topic.

Most of these companies operate by having subscribers pay a monthly fee for different levels of services such as videoconference therapy sessions, supportive text messages, or even some psychopharmacological care. Many also offer the ability to switch rapidly between clinicians if you don’t like the one you have.

These arrangements sound great as the world grows increasingly comfortable with online communication and the mental health needs of children and adolescents increase with the seemingly endless COVID pandemic. Further, research generally finds that online mental health treatment is just as effective as services delivered in person, although the data on therapy by text are less robust.

Nevertheless, a lot of skepticism remains about online mental health treatment, particularly among those involved in more traditionally delivered mental health care. Some of the concerns that often get brought up include the following:
 

• Cost. Most of these online groups, especially the big national companies, don’t interact directly with insurance companies, leaving a lot of out-of-pocket expenses or the need for families to work things out directly with their insurance provider.
• Care fragmentation. In many ways, the online mental health care surge seems at odds with the growing “integrated care” movement that is trying to embed more behavioral care within primary care practices. From this lens, outsourcing someone’s mental health treatment to a therapist across the country that the patient has never actually met seems like a step in the wrong direction. Further, concerns arise about how much these folks will know about local resources in the community.
• The corporate model in mental health care. While being able to shop for a therapist like you would for a pillow sounds great on the surface, there are many times where a patient may need to be supportively confronted by their therapist or told no when asking about things like certain medications. The “customer is always right” principle often falls short when it comes to good mental health treatment.
• Depth and type of treatment. It is probably fair to say that most online therapy could be described as supportive psychotherapy. This type of therapy can be quite helpful for many but may lack the depth or specific techniques that some people need. For youth, some of the most effective types of psychotherapy, like cognitive-behavioral therapy (CBT), can be harder to find, and implement, online.
• Emergencies. While many online companies claim to offer round-the-clock support for paying customers, they can quickly punt to “call your doctor” or even “call 911” if there is any real mental health crisis.

Balancing these potential benefits and pitfalls of online therapy, here are a few questions your patients may want to consider before signing onto a long-term contract with an online therapy company.

• Would the online clinician have any knowledge of my community? In some cases, this may not matter that much, while for others it could be quite important.
• What happens in an emergency? Would the regular online therapist be available to help through a crisis or would things revert back to local resources?
• What about privacy and collaboration? Effective communication between a patient’s primary care clinician and their therapist can be crucial to good care, and asking the patient always to be the intermediary can be fraught with difficulty.
• How long is the contract? Just like those gym memberships, these companies bank on individuals who sign up but then don’t really use the service.
• What kind of training do the therapists at the site have? Is it possible to receive specific types of therapy, like CBT or parent training? Otherwise, pediatricians might be quite likely to hear back from the family wondering about medications after therapy “isn’t helping.”

Overall, mental health treatment delivered by telehealth is here to stay whether we like it or not. For some families, it is likely to provide new access to services not easily obtainable locally, while for others it could end up being a costly and ineffective enterprise. For families who use these services, a key challenge for pediatricians that may be important to overcome is finding a way for these clinicians to integrate into the overall medical team rather than being a detached island unto themselves.
 

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont Larner College of Medicine, Burlington. Follow him on Twitter @PediPsych. His book, “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood” (New York: Oxford University Press, 2021). Email him at [email protected].

If you haven’t noticed yet, there has been an explosion of new online companies specializing in slicing off some little sliver of health care and leaving traditional medicine to take care of the rest of the patient. Lately, many of these startups involve mental health care, traditionally a difficult area to make profitable unless one caters just to the wealthy. Many pediatricians have been unsure exactly what to make of these new efforts. Are these the rescuers we’ve been waiting for to fill what seems like an enormous and growing unmet need? Are they just another means to extract money from desperate people and leave the real work to someone else? Something in-between? This article outlines some points to consider when evaluating this new frontier.

Case vignette

A 12-year-old girl presents with her parents for an annual exam. She has been struggling with her mood and anxiety over the past 2 years along with occasional superficial cutting. You have started treatment with a selective serotonin reuptake inhibitor and have recommended that she see a mental health professional but the parents report that one attempt with a therapist was a poor fit and nobody in the area seems to be accepting new patients. The parents state that they saw an advertisement on TV for a company that offers online psychotherapy by video appointments or text. They think this might be an option to pursue but are a little skeptical of the whole idea. They look for your opinion on this topic.

Most of these companies operate by having subscribers pay a monthly fee for different levels of services such as videoconference therapy sessions, supportive text messages, or even some psychopharmacological care. Many also offer the ability to switch rapidly between clinicians if you don’t like the one you have.

These arrangements sound great as the world grows increasingly comfortable with online communication and the mental health needs of children and adolescents increase with the seemingly endless COVID pandemic. Further, research generally finds that online mental health treatment is just as effective as services delivered in person, although the data on therapy by text are less robust.

Nevertheless, a lot of skepticism remains about online mental health treatment, particularly among those involved in more traditionally delivered mental health care. Some of the concerns that often get brought up include the following:
 

• Cost. Most of these online groups, especially the big national companies, don’t interact directly with insurance companies, leaving a lot of out-of-pocket expenses or the need for families to work things out directly with their insurance provider.
• Care fragmentation. In many ways, the online mental health care surge seems at odds with the growing “integrated care” movement that is trying to embed more behavioral care within primary care practices. From this lens, outsourcing someone’s mental health treatment to a therapist across the country that the patient has never actually met seems like a step in the wrong direction. Further, concerns arise about how much these folks will know about local resources in the community.
• The corporate model in mental health care. While being able to shop for a therapist like you would for a pillow sounds great on the surface, there are many times where a patient may need to be supportively confronted by their therapist or told no when asking about things like certain medications. The “customer is always right” principle often falls short when it comes to good mental health treatment.
• Depth and type of treatment. It is probably fair to say that most online therapy could be described as supportive psychotherapy. This type of therapy can be quite helpful for many but may lack the depth or specific techniques that some people need. For youth, some of the most effective types of psychotherapy, like cognitive-behavioral therapy (CBT), can be harder to find, and implement, online.
• Emergencies. While many online companies claim to offer round-the-clock support for paying customers, they can quickly punt to “call your doctor” or even “call 911” if there is any real mental health crisis.

Balancing these potential benefits and pitfalls of online therapy, here are a few questions your patients may want to consider before signing onto a long-term contract with an online therapy company.

• Would the online clinician have any knowledge of my community? In some cases, this may not matter that much, while for others it could be quite important.
• What happens in an emergency? Would the regular online therapist be available to help through a crisis or would things revert back to local resources?
• What about privacy and collaboration? Effective communication between a patient’s primary care clinician and their therapist can be crucial to good care, and asking the patient always to be the intermediary can be fraught with difficulty.
• How long is the contract? Just like those gym memberships, these companies bank on individuals who sign up but then don’t really use the service.
• What kind of training do the therapists at the site have? Is it possible to receive specific types of therapy, like CBT or parent training? Otherwise, pediatricians might be quite likely to hear back from the family wondering about medications after therapy “isn’t helping.”

Overall, mental health treatment delivered by telehealth is here to stay whether we like it or not. For some families, it is likely to provide new access to services not easily obtainable locally, while for others it could end up being a costly and ineffective enterprise. For families who use these services, a key challenge for pediatricians that may be important to overcome is finding a way for these clinicians to integrate into the overall medical team rather than being a detached island unto themselves.
 

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont Larner College of Medicine, Burlington. Follow him on Twitter @PediPsych. His book, “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood” (New York: Oxford University Press, 2021). Email him at [email protected].

If you haven’t noticed yet, there has been an explosion of new online companies specializing in slicing off some little sliver of health care and leaving traditional medicine to take care of the rest of the patient. Lately, many of these startups involve mental health care, traditionally a difficult area to make profitable unless one caters just to the wealthy. Many pediatricians have been unsure exactly what to make of these new efforts. Are these the rescuers we’ve been waiting for to fill what seems like an enormous and growing unmet need? Are they just another means to extract money from desperate people and leave the real work to someone else? Something in-between? This article outlines some points to consider when evaluating this new frontier.

Case vignette

A 12-year-old girl presents with her parents for an annual exam. She has been struggling with her mood and anxiety over the past 2 years along with occasional superficial cutting. You have started treatment with a selective serotonin reuptake inhibitor and have recommended that she see a mental health professional but the parents report that one attempt with a therapist was a poor fit and nobody in the area seems to be accepting new patients. The parents state that they saw an advertisement on TV for a company that offers online psychotherapy by video appointments or text. They think this might be an option to pursue but are a little skeptical of the whole idea. They look for your opinion on this topic.

Most of these companies operate by having subscribers pay a monthly fee for different levels of services such as videoconference therapy sessions, supportive text messages, or even some psychopharmacological care. Many also offer the ability to switch rapidly between clinicians if you don’t like the one you have.

These arrangements sound great as the world grows increasingly comfortable with online communication and the mental health needs of children and adolescents increase with the seemingly endless COVID pandemic. Further, research generally finds that online mental health treatment is just as effective as services delivered in person, although the data on therapy by text are less robust.

Nevertheless, a lot of skepticism remains about online mental health treatment, particularly among those involved in more traditionally delivered mental health care. Some of the concerns that often get brought up include the following:
 

• Cost. Most of these online groups, especially the big national companies, don’t interact directly with insurance companies, leaving a lot of out-of-pocket expenses or the need for families to work things out directly with their insurance provider.
• Care fragmentation. In many ways, the online mental health care surge seems at odds with the growing “integrated care” movement that is trying to embed more behavioral care within primary care practices. From this lens, outsourcing someone’s mental health treatment to a therapist across the country that the patient has never actually met seems like a step in the wrong direction. Further, concerns arise about how much these folks will know about local resources in the community.
• The corporate model in mental health care. While being able to shop for a therapist like you would for a pillow sounds great on the surface, there are many times where a patient may need to be supportively confronted by their therapist or told no when asking about things like certain medications. The “customer is always right” principle often falls short when it comes to good mental health treatment.
• Depth and type of treatment. It is probably fair to say that most online therapy could be described as supportive psychotherapy. This type of therapy can be quite helpful for many but may lack the depth or specific techniques that some people need. For youth, some of the most effective types of psychotherapy, like cognitive-behavioral therapy (CBT), can be harder to find, and implement, online.
• Emergencies. While many online companies claim to offer round-the-clock support for paying customers, they can quickly punt to “call your doctor” or even “call 911” if there is any real mental health crisis.

Balancing these potential benefits and pitfalls of online therapy, here are a few questions your patients may want to consider before signing onto a long-term contract with an online therapy company.

• Would the online clinician have any knowledge of my community? In some cases, this may not matter that much, while for others it could be quite important.
• What happens in an emergency? Would the regular online therapist be available to help through a crisis or would things revert back to local resources?
• What about privacy and collaboration? Effective communication between a patient’s primary care clinician and their therapist can be crucial to good care, and asking the patient always to be the intermediary can be fraught with difficulty.
• How long is the contract? Just like those gym memberships, these companies bank on individuals who sign up but then don’t really use the service.
• What kind of training do the therapists at the site have? Is it possible to receive specific types of therapy, like CBT or parent training? Otherwise, pediatricians might be quite likely to hear back from the family wondering about medications after therapy “isn’t helping.”

Overall, mental health treatment delivered by telehealth is here to stay whether we like it or not. For some families, it is likely to provide new access to services not easily obtainable locally, while for others it could end up being a costly and ineffective enterprise. For families who use these services, a key challenge for pediatricians that may be important to overcome is finding a way for these clinicians to integrate into the overall medical team rather than being a detached island unto themselves.
 

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont Larner College of Medicine, Burlington. Follow him on Twitter @PediPsych. His book, “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood” (New York: Oxford University Press, 2021). Email him at [email protected].

Seeking novelty is central to adolescence; experimentation is how they explore their identity, exert independence, and establish deep and connected relationships outside of the family. Research over the past 2 decades has demonstrated the neurobiological changes that underpin this increase in sensation seeking. Most adolescents are very good at assessing risk but are willing to tolerate higher levels of risk than adults in the pursuit of novelty.¹ If their knowledge base is limited or inaccurate, as is often the case with drugs and alcohol, accepting higher risk becomes more dangerous. Adolescents are more likely to trust their peers than their parents, but their pediatricians still have authority and credibility.

While there is ample credible information online (from the National Institute on Drug Abuse and the Substance Abuse and Mental Health Services Administration’s excellent websites, which can be recommended to teens), marijuana and hallucinogens (LSD and psilocybin) bear special discussion here because of changing legality and their potential medical utility. There is an emerging impression of safety with both; however, policy changes and for-profit marketing may not reflect the actual scientific evidence. You have the opportunity and authority to complicate your patient’s thinking by discussing the evidence supporting their medical utility, and the emerging evidence that both types of drugs may pose special risks for their developing brains.

By June 2021, marijuana was legal for recreational use in 19 states; Washington, D.C.; and Guam, and for “medical use” in 36 states and four territories. Entrepreneurs and activists have made spectacular claims that marijuana is effective for the treatment of everything from insomnia to PTSD, but the reality is less impressive. Of course, marijuana remains a schedule I drug under the federal Controlled Substances Act (1970), which has made it difficult for researchers to perform randomized controlled studies concerning treatment or risks.

However, there are a growing number of randomized controlled trials with synthetic cannabinoids (dronabinol and nabilone) and a (legal) drug derived from cannabis (cannabidiol or CBD, as distinct from the other active ingredient, tetrahydrocannabinol). There is Food and Drug Administration approval for CBD for the treatment of epilepsy in Lennox-Gastaut or Dravet syndrome in patients aged 2 years or younger, and for the synthetic agents for the treatment of chemotherapy-related nausea and vomiting in cancer patients and for the treatment of weight loss and muscle wasting related to HIV/AIDS. That’s it. There is some evidence that these agents may be effective for the treatment of muscle spasticity in multiple sclerosis, chronic pain of many etiologies, Tourette syndrome, insomnia related to multiple sclerosis and chronic pain, and possibly PTSD. But there have been multiple studies that have failed to demonstrate efficacy (or have demonstrated exacerbation) for a host of other medical and psychiatric problems.

While the evidence for marijuana’s medicinal uses is modest, there is substantial evidence that its use in adolescence carries risks. It is an addictive substance and regular use is associated with sustained modest cognitive impairment (a loss of up to eight IQ points in the clinically dependent) and higher rates of anxiety and depressive disorders. As with other substances, use before the age of 18 substantially raises the risk (as much as sevenfold) of developing addiction than the same rate of use in adulthood. The rate of schizophrenia in adolescents with heavy marijuana use is between six and seven times greater than in the general population, whereas similar adult use does not have this association.^2,3 Studies in rats have demonstrated that use during adolescence delays and permanently changes the maturation of the prefrontal cortex, an area of the brain that is essential for complex decision-making, sustaining attention, abstract reasoning, and impulse control.⁴ While we do not fully understand the exact nature of these changes, there is good reason to believe that regular marijuana use in adolescence leads to disruption of critical brain development and cognitive or even psychotic consequences. It is worth noting that the potency of many commercially available marijuana products is much higher than those that were studied, raising the risk and uncertainty further.

Hallucinogens, or “psychedelics” (from Greek for “mind manifesting”) are a class that includes LSD and psilocybin (a chemical found in over 200 species of mushrooms). They precipitate visual and auditory “hallucinations,” a loss of sense of self, and a sense of awe that may be transcendent or frightening. While psilocybin was used by many indigenous cultures in religious ceremonies, LSD was synthesized by a chemist at Sandoz in 1938 and made widely available for study until it was classified as a schedule I drug by the 1970 Controlled Substances Act. They are not addictive. Early research demonstrated promise in the treatment of alcohol dependence and several psychiatric conditions (including other addictions and treatment-resistant depression). Research resumed in 2018, demonstrating promise in the treatment of depression related to terminal illness. Research has also concerned the nature of consciousness and spiritual experiences. Hallucinogens have become popular in certain fields (high tech) as a means of optimizing creativity and performance (“microdosing”). There is modest evidence that use in people with a family history of psychotic illness may precipitate sustained psychotic symptoms. Regular use may further increase the risk of persistent psychosis and adolescent users of multiple substances are at high risk for regular hallucinogen use. Adolescents may think that ketamine, phencyclidine , and 3,4-methylenedioxymethamphetamine are also in this category, although they are different and considerably more risky drugs. Overall, these agents show therapeutic promise, but unless your young patients are facing depression related to a terminal illness and until we learn more from studies, the potential risk to their developing brains outweighs any potential benefits.

Aware of this information, you are ready to ask your adolescent patients about their drug and alcohol use and knowledge. Using phrases like “when did you first try ...” can increase the likelihood that your patients will be forthright with you. Or start by asking about what their friends are trying and talking about. Be curious about any drug and alcohol use at home. Find out what they are curious about, whom they trust, and where they get their information. Then you can offer your information about the dramatic changes happening in their brains (just like the rest of their bodies) and the special risks of drug use during this window of brain development. Acknowledge that the risks of marijuana use in adults may very well be lower than the risks of regular alcohol use but remind them about how their brains are different than those of adults. Delaying use until they are 18 (or ideally in their mid-20s when most brain development is complete), can dramatically lower these risks. For adolescents with a family history of addiction, psychosis, or mood and anxiety disorders, discuss the additional risks that drugs may present to them. And for those adolescents who acknowledge very early (before 13) or heavy use, be curious with them about whether they might be trying to “feel better” and not just “feel good.” Screen them for depression, suicidality, and anxiety disorders. Those underlying problems are treatable, but their course will only worsen with drug and alcohol use. You are in a unique position to help your adolescent patients make wise and well-informed choices and to get them assistance if they need it.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

References

1. Romer D. Dev Psychobiol. 2010 Apr;52(3):263-76.

2. Szczepanski SM and Knight TR. Neuron. 2014;83:1002-18.

3. Renard J et al. Front Psychiatry. 2018;9:281.

4. Shen H. Proc Natl Acad Sci U S A. 2020 Jan 7;117(1):7-11.

Seeking novelty is central to adolescence; experimentation is how they explore their identity, exert independence, and establish deep and connected relationships outside of the family. Research over the past 2 decades has demonstrated the neurobiological changes that underpin this increase in sensation seeking. Most adolescents are very good at assessing risk but are willing to tolerate higher levels of risk than adults in the pursuit of novelty.¹ If their knowledge base is limited or inaccurate, as is often the case with drugs and alcohol, accepting higher risk becomes more dangerous. Adolescents are more likely to trust their peers than their parents, but their pediatricians still have authority and credibility.

While there is ample credible information online (from the National Institute on Drug Abuse and the Substance Abuse and Mental Health Services Administration’s excellent websites, which can be recommended to teens), marijuana and hallucinogens (LSD and psilocybin) bear special discussion here because of changing legality and their potential medical utility. There is an emerging impression of safety with both; however, policy changes and for-profit marketing may not reflect the actual scientific evidence. You have the opportunity and authority to complicate your patient’s thinking by discussing the evidence supporting their medical utility, and the emerging evidence that both types of drugs may pose special risks for their developing brains.

By June 2021, marijuana was legal for recreational use in 19 states; Washington, D.C.; and Guam, and for “medical use” in 36 states and four territories. Entrepreneurs and activists have made spectacular claims that marijuana is effective for the treatment of everything from insomnia to PTSD, but the reality is less impressive. Of course, marijuana remains a schedule I drug under the federal Controlled Substances Act (1970), which has made it difficult for researchers to perform randomized controlled studies concerning treatment or risks.

However, there are a growing number of randomized controlled trials with synthetic cannabinoids (dronabinol and nabilone) and a (legal) drug derived from cannabis (cannabidiol or CBD, as distinct from the other active ingredient, tetrahydrocannabinol). There is Food and Drug Administration approval for CBD for the treatment of epilepsy in Lennox-Gastaut or Dravet syndrome in patients aged 2 years or younger, and for the synthetic agents for the treatment of chemotherapy-related nausea and vomiting in cancer patients and for the treatment of weight loss and muscle wasting related to HIV/AIDS. That’s it. There is some evidence that these agents may be effective for the treatment of muscle spasticity in multiple sclerosis, chronic pain of many etiologies, Tourette syndrome, insomnia related to multiple sclerosis and chronic pain, and possibly PTSD. But there have been multiple studies that have failed to demonstrate efficacy (or have demonstrated exacerbation) for a host of other medical and psychiatric problems.

While the evidence for marijuana’s medicinal uses is modest, there is substantial evidence that its use in adolescence carries risks. It is an addictive substance and regular use is associated with sustained modest cognitive impairment (a loss of up to eight IQ points in the clinically dependent) and higher rates of anxiety and depressive disorders. As with other substances, use before the age of 18 substantially raises the risk (as much as sevenfold) of developing addiction than the same rate of use in adulthood. The rate of schizophrenia in adolescents with heavy marijuana use is between six and seven times greater than in the general population, whereas similar adult use does not have this association.^2,3 Studies in rats have demonstrated that use during adolescence delays and permanently changes the maturation of the prefrontal cortex, an area of the brain that is essential for complex decision-making, sustaining attention, abstract reasoning, and impulse control.⁴ While we do not fully understand the exact nature of these changes, there is good reason to believe that regular marijuana use in adolescence leads to disruption of critical brain development and cognitive or even psychotic consequences. It is worth noting that the potency of many commercially available marijuana products is much higher than those that were studied, raising the risk and uncertainty further.

Hallucinogens, or “psychedelics” (from Greek for “mind manifesting”) are a class that includes LSD and psilocybin (a chemical found in over 200 species of mushrooms). They precipitate visual and auditory “hallucinations,” a loss of sense of self, and a sense of awe that may be transcendent or frightening. While psilocybin was used by many indigenous cultures in religious ceremonies, LSD was synthesized by a chemist at Sandoz in 1938 and made widely available for study until it was classified as a schedule I drug by the 1970 Controlled Substances Act. They are not addictive. Early research demonstrated promise in the treatment of alcohol dependence and several psychiatric conditions (including other addictions and treatment-resistant depression). Research resumed in 2018, demonstrating promise in the treatment of depression related to terminal illness. Research has also concerned the nature of consciousness and spiritual experiences. Hallucinogens have become popular in certain fields (high tech) as a means of optimizing creativity and performance (“microdosing”). There is modest evidence that use in people with a family history of psychotic illness may precipitate sustained psychotic symptoms. Regular use may further increase the risk of persistent psychosis and adolescent users of multiple substances are at high risk for regular hallucinogen use. Adolescents may think that ketamine, phencyclidine , and 3,4-methylenedioxymethamphetamine are also in this category, although they are different and considerably more risky drugs. Overall, these agents show therapeutic promise, but unless your young patients are facing depression related to a terminal illness and until we learn more from studies, the potential risk to their developing brains outweighs any potential benefits.

Aware of this information, you are ready to ask your adolescent patients about their drug and alcohol use and knowledge. Using phrases like “when did you first try ...” can increase the likelihood that your patients will be forthright with you. Or start by asking about what their friends are trying and talking about. Be curious about any drug and alcohol use at home. Find out what they are curious about, whom they trust, and where they get their information. Then you can offer your information about the dramatic changes happening in their brains (just like the rest of their bodies) and the special risks of drug use during this window of brain development. Acknowledge that the risks of marijuana use in adults may very well be lower than the risks of regular alcohol use but remind them about how their brains are different than those of adults. Delaying use until they are 18 (or ideally in their mid-20s when most brain development is complete), can dramatically lower these risks. For adolescents with a family history of addiction, psychosis, or mood and anxiety disorders, discuss the additional risks that drugs may present to them. And for those adolescents who acknowledge very early (before 13) or heavy use, be curious with them about whether they might be trying to “feel better” and not just “feel good.” Screen them for depression, suicidality, and anxiety disorders. Those underlying problems are treatable, but their course will only worsen with drug and alcohol use. You are in a unique position to help your adolescent patients make wise and well-informed choices and to get them assistance if they need it.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

References

1. Romer D. Dev Psychobiol. 2010 Apr;52(3):263-76.

2. Szczepanski SM and Knight TR. Neuron. 2014;83:1002-18.

3. Renard J et al. Front Psychiatry. 2018;9:281.

4. Shen H. Proc Natl Acad Sci U S A. 2020 Jan 7;117(1):7-11.

Seeking novelty is central to adolescence; experimentation is how they explore their identity, exert independence, and establish deep and connected relationships outside of the family. Research over the past 2 decades has demonstrated the neurobiological changes that underpin this increase in sensation seeking. Most adolescents are very good at assessing risk but are willing to tolerate higher levels of risk than adults in the pursuit of novelty.¹ If their knowledge base is limited or inaccurate, as is often the case with drugs and alcohol, accepting higher risk becomes more dangerous. Adolescents are more likely to trust their peers than their parents, but their pediatricians still have authority and credibility.

While there is ample credible information online (from the National Institute on Drug Abuse and the Substance Abuse and Mental Health Services Administration’s excellent websites, which can be recommended to teens), marijuana and hallucinogens (LSD and psilocybin) bear special discussion here because of changing legality and their potential medical utility. There is an emerging impression of safety with both; however, policy changes and for-profit marketing may not reflect the actual scientific evidence. You have the opportunity and authority to complicate your patient’s thinking by discussing the evidence supporting their medical utility, and the emerging evidence that both types of drugs may pose special risks for their developing brains.

By June 2021, marijuana was legal for recreational use in 19 states; Washington, D.C.; and Guam, and for “medical use” in 36 states and four territories. Entrepreneurs and activists have made spectacular claims that marijuana is effective for the treatment of everything from insomnia to PTSD, but the reality is less impressive. Of course, marijuana remains a schedule I drug under the federal Controlled Substances Act (1970), which has made it difficult for researchers to perform randomized controlled studies concerning treatment or risks.

However, there are a growing number of randomized controlled trials with synthetic cannabinoids (dronabinol and nabilone) and a (legal) drug derived from cannabis (cannabidiol or CBD, as distinct from the other active ingredient, tetrahydrocannabinol). There is Food and Drug Administration approval for CBD for the treatment of epilepsy in Lennox-Gastaut or Dravet syndrome in patients aged 2 years or younger, and for the synthetic agents for the treatment of chemotherapy-related nausea and vomiting in cancer patients and for the treatment of weight loss and muscle wasting related to HIV/AIDS. That’s it. There is some evidence that these agents may be effective for the treatment of muscle spasticity in multiple sclerosis, chronic pain of many etiologies, Tourette syndrome, insomnia related to multiple sclerosis and chronic pain, and possibly PTSD. But there have been multiple studies that have failed to demonstrate efficacy (or have demonstrated exacerbation) for a host of other medical and psychiatric problems.

While the evidence for marijuana’s medicinal uses is modest, there is substantial evidence that its use in adolescence carries risks. It is an addictive substance and regular use is associated with sustained modest cognitive impairment (a loss of up to eight IQ points in the clinically dependent) and higher rates of anxiety and depressive disorders. As with other substances, use before the age of 18 substantially raises the risk (as much as sevenfold) of developing addiction than the same rate of use in adulthood. The rate of schizophrenia in adolescents with heavy marijuana use is between six and seven times greater than in the general population, whereas similar adult use does not have this association.^2,3 Studies in rats have demonstrated that use during adolescence delays and permanently changes the maturation of the prefrontal cortex, an area of the brain that is essential for complex decision-making, sustaining attention, abstract reasoning, and impulse control.⁴ While we do not fully understand the exact nature of these changes, there is good reason to believe that regular marijuana use in adolescence leads to disruption of critical brain development and cognitive or even psychotic consequences. It is worth noting that the potency of many commercially available marijuana products is much higher than those that were studied, raising the risk and uncertainty further.

Hallucinogens, or “psychedelics” (from Greek for “mind manifesting”) are a class that includes LSD and psilocybin (a chemical found in over 200 species of mushrooms). They precipitate visual and auditory “hallucinations,” a loss of sense of self, and a sense of awe that may be transcendent or frightening. While psilocybin was used by many indigenous cultures in religious ceremonies, LSD was synthesized by a chemist at Sandoz in 1938 and made widely available for study until it was classified as a schedule I drug by the 1970 Controlled Substances Act. They are not addictive. Early research demonstrated promise in the treatment of alcohol dependence and several psychiatric conditions (including other addictions and treatment-resistant depression). Research resumed in 2018, demonstrating promise in the treatment of depression related to terminal illness. Research has also concerned the nature of consciousness and spiritual experiences. Hallucinogens have become popular in certain fields (high tech) as a means of optimizing creativity and performance (“microdosing”). There is modest evidence that use in people with a family history of psychotic illness may precipitate sustained psychotic symptoms. Regular use may further increase the risk of persistent psychosis and adolescent users of multiple substances are at high risk for regular hallucinogen use. Adolescents may think that ketamine, phencyclidine , and 3,4-methylenedioxymethamphetamine are also in this category, although they are different and considerably more risky drugs. Overall, these agents show therapeutic promise, but unless your young patients are facing depression related to a terminal illness and until we learn more from studies, the potential risk to their developing brains outweighs any potential benefits.

Aware of this information, you are ready to ask your adolescent patients about their drug and alcohol use and knowledge. Using phrases like “when did you first try ...” can increase the likelihood that your patients will be forthright with you. Or start by asking about what their friends are trying and talking about. Be curious about any drug and alcohol use at home. Find out what they are curious about, whom they trust, and where they get their information. Then you can offer your information about the dramatic changes happening in their brains (just like the rest of their bodies) and the special risks of drug use during this window of brain development. Acknowledge that the risks of marijuana use in adults may very well be lower than the risks of regular alcohol use but remind them about how their brains are different than those of adults. Delaying use until they are 18 (or ideally in their mid-20s when most brain development is complete), can dramatically lower these risks. For adolescents with a family history of addiction, psychosis, or mood and anxiety disorders, discuss the additional risks that drugs may present to them. And for those adolescents who acknowledge very early (before 13) or heavy use, be curious with them about whether they might be trying to “feel better” and not just “feel good.” Screen them for depression, suicidality, and anxiety disorders. Those underlying problems are treatable, but their course will only worsen with drug and alcohol use. You are in a unique position to help your adolescent patients make wise and well-informed choices and to get them assistance if they need it.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].

References

1. Romer D. Dev Psychobiol. 2010 Apr;52(3):263-76.

2. Szczepanski SM and Knight TR. Neuron. 2014;83:1002-18.

3. Renard J et al. Front Psychiatry. 2018;9:281.

4. Shen H. Proc Natl Acad Sci U S A. 2020 Jan 7;117(1):7-11.

The high school football team here in Brunswick has had winning years and losing years but the school has always fielded a competitive team. It has been state champion on several occasions and has weathered the challenge when soccer became the new and more popular sport shortly after it arrived in town several decades ago. But this year, on the heels of a strong winning season last year, the numbers are down significantly. The school is in jeopardy of not having enough players to field a junior varsity team.

This dearth of student athletes is a problem not just here in Brunswick. Schools across the state of Maine are being forced to shift to an eight man football format. Nor is it unique to football here in vacationland. A recent article in a Hudson Valley, N.Y., newspaper chronicles a broad-based decline in participation in high school sports including field hockey, tennis, and cross country (‘Covid,’ The Journal News, Nancy Haggerty, Sept. 5, 2021). In many situations the school may have enough players to field a varsity team but too few to play a junior varsity schedule. Without a supply of young talent coming up from the junior varsity, the future of any varsity program is on a shaky legs. Some of the coaches are referring to the decline in participation as a “COVID hangover” triggered in part by season disruptions, cancellations, and fluctuating remote learning formats.

I and some other coaches argue that the participation drought predates the pandemic and is the result of a wide range of unfortunate trends. First, is the general malaise and don’t-give-a-damn-about-anything attitude that has settled on the young people of this country, the causes of which are difficult to define. It may be that after years of sitting in front of a video screen, too many children have settled into the role of being spectators and find the energy it takes to participate just isn’t worth the effort.

Another contributor to the decline in participation is the heavy of emphasis on early specialization. Driven in many cases by unrealistic parental dreams, children are shepherded into elite travel teams with seasons that often stretch to lengths that make it difficult if not impossible for a child to participate in other sports. The child who may simply be a late bloomer or whose family can’t afford the time or money to buy into the travel team ethic quickly finds himself losing ground. Without the additional opportunities for skill development, many of the children noon travel teams eventually wonder if it is worth trying to catch up. Ironically, the trend toward early specialization is short-sighted because many college and professional coaches report that their best athletes shunned becoming one-trick ponies and played a variety of sports growing up.

Parental concerns about injury, particularly concussion, probably play a role in the trend of falling participation in sports, even those with minimal risk of head injury. Certainly our new awareness of the long-term effects of multiple concussions is long overdue. However, we as pediatricians must take some of the blame for often emphasizing the injury risk inherent in sports in general while neglecting to highlight the positive benefits of competitive sports such as fitness and team building. Are there situations where our emphasis on preparticipation physicals is acting as a deterrent?

There are exceptions to the general trend of falling participation, lacrosse being the most obvious example. However, as lacrosse becomes more popular across the country there are signs that it is already drifting into the larger and counterproductive elite travel team model. There have always been communities in which an individual coach or parent has created a team culture that is both inclusive and competitive. The two are not mutually exclusive.

Sadly, these exceptional programs are few and far between. I’m not sure where we can start to turn things around so that more children choose to be players rather than observers. But, we pediatricians certainly can play a more positive role in emphasizing the benefits of team play.
 

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].

The high school football team here in Brunswick has had winning years and losing years but the school has always fielded a competitive team. It has been state champion on several occasions and has weathered the challenge when soccer became the new and more popular sport shortly after it arrived in town several decades ago. But this year, on the heels of a strong winning season last year, the numbers are down significantly. The school is in jeopardy of not having enough players to field a junior varsity team.

This dearth of student athletes is a problem not just here in Brunswick. Schools across the state of Maine are being forced to shift to an eight man football format. Nor is it unique to football here in vacationland. A recent article in a Hudson Valley, N.Y., newspaper chronicles a broad-based decline in participation in high school sports including field hockey, tennis, and cross country (‘Covid,’ The Journal News, Nancy Haggerty, Sept. 5, 2021). In many situations the school may have enough players to field a varsity team but too few to play a junior varsity schedule. Without a supply of young talent coming up from the junior varsity, the future of any varsity program is on a shaky legs. Some of the coaches are referring to the decline in participation as a “COVID hangover” triggered in part by season disruptions, cancellations, and fluctuating remote learning formats.

I and some other coaches argue that the participation drought predates the pandemic and is the result of a wide range of unfortunate trends. First, is the general malaise and don’t-give-a-damn-about-anything attitude that has settled on the young people of this country, the causes of which are difficult to define. It may be that after years of sitting in front of a video screen, too many children have settled into the role of being spectators and find the energy it takes to participate just isn’t worth the effort.

Another contributor to the decline in participation is the heavy of emphasis on early specialization. Driven in many cases by unrealistic parental dreams, children are shepherded into elite travel teams with seasons that often stretch to lengths that make it difficult if not impossible for a child to participate in other sports. The child who may simply be a late bloomer or whose family can’t afford the time or money to buy into the travel team ethic quickly finds himself losing ground. Without the additional opportunities for skill development, many of the children noon travel teams eventually wonder if it is worth trying to catch up. Ironically, the trend toward early specialization is short-sighted because many college and professional coaches report that their best athletes shunned becoming one-trick ponies and played a variety of sports growing up.

Parental concerns about injury, particularly concussion, probably play a role in the trend of falling participation in sports, even those with minimal risk of head injury. Certainly our new awareness of the long-term effects of multiple concussions is long overdue. However, we as pediatricians must take some of the blame for often emphasizing the injury risk inherent in sports in general while neglecting to highlight the positive benefits of competitive sports such as fitness and team building. Are there situations where our emphasis on preparticipation physicals is acting as a deterrent?

There are exceptions to the general trend of falling participation, lacrosse being the most obvious example. However, as lacrosse becomes more popular across the country there are signs that it is already drifting into the larger and counterproductive elite travel team model. There have always been communities in which an individual coach or parent has created a team culture that is both inclusive and competitive. The two are not mutually exclusive.

Sadly, these exceptional programs are few and far between. I’m not sure where we can start to turn things around so that more children choose to be players rather than observers. But, we pediatricians certainly can play a more positive role in emphasizing the benefits of team play.
 

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].

The high school football team here in Brunswick has had winning years and losing years but the school has always fielded a competitive team. It has been state champion on several occasions and has weathered the challenge when soccer became the new and more popular sport shortly after it arrived in town several decades ago. But this year, on the heels of a strong winning season last year, the numbers are down significantly. The school is in jeopardy of not having enough players to field a junior varsity team.

This dearth of student athletes is a problem not just here in Brunswick. Schools across the state of Maine are being forced to shift to an eight man football format. Nor is it unique to football here in vacationland. A recent article in a Hudson Valley, N.Y., newspaper chronicles a broad-based decline in participation in high school sports including field hockey, tennis, and cross country (‘Covid,’ The Journal News, Nancy Haggerty, Sept. 5, 2021). In many situations the school may have enough players to field a varsity team but too few to play a junior varsity schedule. Without a supply of young talent coming up from the junior varsity, the future of any varsity program is on a shaky legs. Some of the coaches are referring to the decline in participation as a “COVID hangover” triggered in part by season disruptions, cancellations, and fluctuating remote learning formats.

I and some other coaches argue that the participation drought predates the pandemic and is the result of a wide range of unfortunate trends. First, is the general malaise and don’t-give-a-damn-about-anything attitude that has settled on the young people of this country, the causes of which are difficult to define. It may be that after years of sitting in front of a video screen, too many children have settled into the role of being spectators and find the energy it takes to participate just isn’t worth the effort.

Another contributor to the decline in participation is the heavy of emphasis on early specialization. Driven in many cases by unrealistic parental dreams, children are shepherded into elite travel teams with seasons that often stretch to lengths that make it difficult if not impossible for a child to participate in other sports. The child who may simply be a late bloomer or whose family can’t afford the time or money to buy into the travel team ethic quickly finds himself losing ground. Without the additional opportunities for skill development, many of the children noon travel teams eventually wonder if it is worth trying to catch up. Ironically, the trend toward early specialization is short-sighted because many college and professional coaches report that their best athletes shunned becoming one-trick ponies and played a variety of sports growing up.

Parental concerns about injury, particularly concussion, probably play a role in the trend of falling participation in sports, even those with minimal risk of head injury. Certainly our new awareness of the long-term effects of multiple concussions is long overdue. However, we as pediatricians must take some of the blame for often emphasizing the injury risk inherent in sports in general while neglecting to highlight the positive benefits of competitive sports such as fitness and team building. Are there situations where our emphasis on preparticipation physicals is acting as a deterrent?

There are exceptions to the general trend of falling participation, lacrosse being the most obvious example. However, as lacrosse becomes more popular across the country there are signs that it is already drifting into the larger and counterproductive elite travel team model. There have always been communities in which an individual coach or parent has created a team culture that is both inclusive and competitive. The two are not mutually exclusive.

Sadly, these exceptional programs are few and far between. I’m not sure where we can start to turn things around so that more children choose to be players rather than observers. But, we pediatricians certainly can play a more positive role in emphasizing the benefits of team play.
 

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].

The judge’s order was a major affront to many clinical ethicists. A county judge in Ohio ordered a hospital to give ivermectin to a COVID-19 patient on a ventilator. This order occurred against the advice and judgment of the local physicians. It occurred in spite of the hospital’s lawyers fighting the order. How could such a situation occur?

This column is not the appropriate forum to debate the use of ivermectin. The Food and Drug Administration has not approved the drug for treating COVID-19. Indeed, the FDA has specifically recommended against its use.¹ So has the Centers for Disease Control and Prevention.² Poison control centers report a large uptick in exposures this summer because of self-medication, sometimes from veterinary sources.³

Fortunately for this case, the judge who overruled the order, Judge Michael A. Oster, wrote in his decision a summary of facts presented by both sides. The topic here is how a judge could order a medical institution and its staff to provide care against medical judgment. A key tenet of clinical ethics consultation is that the consultant needs to do their own investigation. Most veteran consultants have a litany of anecdotes wherein the initial story changed markedly as new facts were uncovered. The more outrageous the initial story, the more likely a major distortion is found. Therefore, most clinical ethics consultants are reluctant to discuss case studies based solely on publicly available information. Often, it is nearly impossible to obtain further information. One side of the story may be gagged by privacy laws. However, cases must sometimes be discussed based on the limited information available because, without that discussion, egregious violations of medical ethics would not be brought to light.

Fortunately for this case, Judge Osler’s decision contains a summary of facts presented by both sides. In August 2021, a 51-year-old patient with severe COVID-19 is in an Ohio intensive care unit on a ventilator. His wife seeks and obtains a prescription for ivermectin from a physician who has an Ohio state medical license but lives elsewhere, has no clinical privileges at the involved hospital, and has never examined the patient. The wife, as a surrogate decision maker, demands her husband receive the medication. The medical staff involved do not consider it a valid treatment. The wife seeks an injunction. A county judge orders the hospital to administer a specified dose of ivermectin daily for 21 days.⁴ That judge further grants an emergency preliminary injunction for 14 days that orders administration of the medication while legal appeals are made. Two weeks later, a second county judge hearing the case rules that the wife has not presented convincing evidence that she is likely to ultimately win the case on the merits.⁵ Therefore, the second judge reverses the preliminary injunction. The hospital need not continue to give the medication while further legal proceedings take place.

Cases like this are uncommon. Judges generally defer the authority for medical decisions to physicians. Various attitudes combine to make such an event happen. The judge may view the hospital as a local monopoly of health care and the patient may be too unstable to transport elsewhere. A judge in that situation, combined with a “the consumer is always right” mentality, and a sympathetic plaintiff, may seek to make miracles happen.

Judges overriding science are more likely to manifest when they see the science as ambiguous. Scientists have lost some of the gravitas they had when men walked on the moon. The spectacular success of the mRNA vaccines has surprisingly not reversed that loss. Science has been tainted by mercenary scientists, biased researchers seeking publications, and the large volume of published medical research that is false.

But there is more going on here. In the United States there has been a significant rebellion against any form of expertise and any form of authority. The echo chambers of misinformation on social media have led to polarization, conspiracy theories, and loyalty to political tribe rather than truth; hence the battle over masks and vaccines. This breakdown in authority is accompanied by losses in virtues such as civic duty and loving one’s neighbor. This is a failure of modern moral institutions. When major medical journals print opinion pieces portraying physicians as interchangeable automatons,⁶ it should not be surprising to see judges tempted by similar imagery.

One part of the solution is accountability in peer review. With 30,000 county judges scattered in 50 states, there will always be a few rogue and maverick attitudes among judges. The judiciary has a means of reassigning rebels to less impactful tasks. Similarly, if the physician who counseled the wife to use ivermectin had privileges at the admitting hospital, then peer review and credential committees could discipline behaviors that were too far outside accepted norms. Even when a consensus on best practice is hard to establish, damage can be mitigated by creating consequences for promoting aberrant care.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

References

1. “Why you should not use ivermectin to treat or prevent COVID-19,” FDA Consumer Updates, Sept. 3, 2021.

2. “Rapid increase in ivermectin prescriptions and reports of severe illness associated with use of products containing ivermectin to prevent or treat COVID-19,” CDC Health Advisory, Aug. 26, 2021.

3. National Poison Data System Bulletin: COVID-19 (Ivermectin), American Association of Poison Control Centers, 2021.

4. Smith v West Chester Hosptial, LLC, DBA West Chester Hospital, Butler County Clerk of Courts, Aug. 23, 2021.

5. Smith v West Chester Hosptial, LLC, Decision denying plaintiff’s action for a preliminary injunction, Butler County Clerk of Courts, Sept. 6, 2021.

6. “Conscientious objection in medicine,” BMJ 2006 Feb 2. doi: 10.1136/bmj.332.7536.294.

The judge’s order was a major affront to many clinical ethicists. A county judge in Ohio ordered a hospital to give ivermectin to a COVID-19 patient on a ventilator. This order occurred against the advice and judgment of the local physicians. It occurred in spite of the hospital’s lawyers fighting the order. How could such a situation occur?

This column is not the appropriate forum to debate the use of ivermectin. The Food and Drug Administration has not approved the drug for treating COVID-19. Indeed, the FDA has specifically recommended against its use.¹ So has the Centers for Disease Control and Prevention.² Poison control centers report a large uptick in exposures this summer because of self-medication, sometimes from veterinary sources.³

Fortunately for this case, the judge who overruled the order, Judge Michael A. Oster, wrote in his decision a summary of facts presented by both sides. The topic here is how a judge could order a medical institution and its staff to provide care against medical judgment. A key tenet of clinical ethics consultation is that the consultant needs to do their own investigation. Most veteran consultants have a litany of anecdotes wherein the initial story changed markedly as new facts were uncovered. The more outrageous the initial story, the more likely a major distortion is found. Therefore, most clinical ethics consultants are reluctant to discuss case studies based solely on publicly available information. Often, it is nearly impossible to obtain further information. One side of the story may be gagged by privacy laws. However, cases must sometimes be discussed based on the limited information available because, without that discussion, egregious violations of medical ethics would not be brought to light.

Fortunately for this case, Judge Osler’s decision contains a summary of facts presented by both sides. In August 2021, a 51-year-old patient with severe COVID-19 is in an Ohio intensive care unit on a ventilator. His wife seeks and obtains a prescription for ivermectin from a physician who has an Ohio state medical license but lives elsewhere, has no clinical privileges at the involved hospital, and has never examined the patient. The wife, as a surrogate decision maker, demands her husband receive the medication. The medical staff involved do not consider it a valid treatment. The wife seeks an injunction. A county judge orders the hospital to administer a specified dose of ivermectin daily for 21 days.⁴ That judge further grants an emergency preliminary injunction for 14 days that orders administration of the medication while legal appeals are made. Two weeks later, a second county judge hearing the case rules that the wife has not presented convincing evidence that she is likely to ultimately win the case on the merits.⁵ Therefore, the second judge reverses the preliminary injunction. The hospital need not continue to give the medication while further legal proceedings take place.

Cases like this are uncommon. Judges generally defer the authority for medical decisions to physicians. Various attitudes combine to make such an event happen. The judge may view the hospital as a local monopoly of health care and the patient may be too unstable to transport elsewhere. A judge in that situation, combined with a “the consumer is always right” mentality, and a sympathetic plaintiff, may seek to make miracles happen.

Judges overriding science are more likely to manifest when they see the science as ambiguous. Scientists have lost some of the gravitas they had when men walked on the moon. The spectacular success of the mRNA vaccines has surprisingly not reversed that loss. Science has been tainted by mercenary scientists, biased researchers seeking publications, and the large volume of published medical research that is false.

But there is more going on here. In the United States there has been a significant rebellion against any form of expertise and any form of authority. The echo chambers of misinformation on social media have led to polarization, conspiracy theories, and loyalty to political tribe rather than truth; hence the battle over masks and vaccines. This breakdown in authority is accompanied by losses in virtues such as civic duty and loving one’s neighbor. This is a failure of modern moral institutions. When major medical journals print opinion pieces portraying physicians as interchangeable automatons,⁶ it should not be surprising to see judges tempted by similar imagery.

One part of the solution is accountability in peer review. With 30,000 county judges scattered in 50 states, there will always be a few rogue and maverick attitudes among judges. The judiciary has a means of reassigning rebels to less impactful tasks. Similarly, if the physician who counseled the wife to use ivermectin had privileges at the admitting hospital, then peer review and credential committees could discipline behaviors that were too far outside accepted norms. Even when a consensus on best practice is hard to establish, damage can be mitigated by creating consequences for promoting aberrant care.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

References

1. “Why you should not use ivermectin to treat or prevent COVID-19,” FDA Consumer Updates, Sept. 3, 2021.

2. “Rapid increase in ivermectin prescriptions and reports of severe illness associated with use of products containing ivermectin to prevent or treat COVID-19,” CDC Health Advisory, Aug. 26, 2021.

3. National Poison Data System Bulletin: COVID-19 (Ivermectin), American Association of Poison Control Centers, 2021.

4. Smith v West Chester Hosptial, LLC, DBA West Chester Hospital, Butler County Clerk of Courts, Aug. 23, 2021.

5. Smith v West Chester Hosptial, LLC, Decision denying plaintiff’s action for a preliminary injunction, Butler County Clerk of Courts, Sept. 6, 2021.

6. “Conscientious objection in medicine,” BMJ 2006 Feb 2. doi: 10.1136/bmj.332.7536.294.

The judge’s order was a major affront to many clinical ethicists. A county judge in Ohio ordered a hospital to give ivermectin to a COVID-19 patient on a ventilator. This order occurred against the advice and judgment of the local physicians. It occurred in spite of the hospital’s lawyers fighting the order. How could such a situation occur?

This column is not the appropriate forum to debate the use of ivermectin. The Food and Drug Administration has not approved the drug for treating COVID-19. Indeed, the FDA has specifically recommended against its use.¹ So has the Centers for Disease Control and Prevention.² Poison control centers report a large uptick in exposures this summer because of self-medication, sometimes from veterinary sources.³

Fortunately for this case, the judge who overruled the order, Judge Michael A. Oster, wrote in his decision a summary of facts presented by both sides. The topic here is how a judge could order a medical institution and its staff to provide care against medical judgment. A key tenet of clinical ethics consultation is that the consultant needs to do their own investigation. Most veteran consultants have a litany of anecdotes wherein the initial story changed markedly as new facts were uncovered. The more outrageous the initial story, the more likely a major distortion is found. Therefore, most clinical ethics consultants are reluctant to discuss case studies based solely on publicly available information. Often, it is nearly impossible to obtain further information. One side of the story may be gagged by privacy laws. However, cases must sometimes be discussed based on the limited information available because, without that discussion, egregious violations of medical ethics would not be brought to light.

Fortunately for this case, Judge Osler’s decision contains a summary of facts presented by both sides. In August 2021, a 51-year-old patient with severe COVID-19 is in an Ohio intensive care unit on a ventilator. His wife seeks and obtains a prescription for ivermectin from a physician who has an Ohio state medical license but lives elsewhere, has no clinical privileges at the involved hospital, and has never examined the patient. The wife, as a surrogate decision maker, demands her husband receive the medication. The medical staff involved do not consider it a valid treatment. The wife seeks an injunction. A county judge orders the hospital to administer a specified dose of ivermectin daily for 21 days.⁴ That judge further grants an emergency preliminary injunction for 14 days that orders administration of the medication while legal appeals are made. Two weeks later, a second county judge hearing the case rules that the wife has not presented convincing evidence that she is likely to ultimately win the case on the merits.⁵ Therefore, the second judge reverses the preliminary injunction. The hospital need not continue to give the medication while further legal proceedings take place.

Cases like this are uncommon. Judges generally defer the authority for medical decisions to physicians. Various attitudes combine to make such an event happen. The judge may view the hospital as a local monopoly of health care and the patient may be too unstable to transport elsewhere. A judge in that situation, combined with a “the consumer is always right” mentality, and a sympathetic plaintiff, may seek to make miracles happen.

Judges overriding science are more likely to manifest when they see the science as ambiguous. Scientists have lost some of the gravitas they had when men walked on the moon. The spectacular success of the mRNA vaccines has surprisingly not reversed that loss. Science has been tainted by mercenary scientists, biased researchers seeking publications, and the large volume of published medical research that is false.

But there is more going on here. In the United States there has been a significant rebellion against any form of expertise and any form of authority. The echo chambers of misinformation on social media have led to polarization, conspiracy theories, and loyalty to political tribe rather than truth; hence the battle over masks and vaccines. This breakdown in authority is accompanied by losses in virtues such as civic duty and loving one’s neighbor. This is a failure of modern moral institutions. When major medical journals print opinion pieces portraying physicians as interchangeable automatons,⁶ it should not be surprising to see judges tempted by similar imagery.

One part of the solution is accountability in peer review. With 30,000 county judges scattered in 50 states, there will always be a few rogue and maverick attitudes among judges. The judiciary has a means of reassigning rebels to less impactful tasks. Similarly, if the physician who counseled the wife to use ivermectin had privileges at the admitting hospital, then peer review and credential committees could discipline behaviors that were too far outside accepted norms. Even when a consensus on best practice is hard to establish, damage can be mitigated by creating consequences for promoting aberrant care.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

References

1. “Why you should not use ivermectin to treat or prevent COVID-19,” FDA Consumer Updates, Sept. 3, 2021.

2. “Rapid increase in ivermectin prescriptions and reports of severe illness associated with use of products containing ivermectin to prevent or treat COVID-19,” CDC Health Advisory, Aug. 26, 2021.

3. National Poison Data System Bulletin: COVID-19 (Ivermectin), American Association of Poison Control Centers, 2021.

4. Smith v West Chester Hosptial, LLC, DBA West Chester Hospital, Butler County Clerk of Courts, Aug. 23, 2021.

5. Smith v West Chester Hosptial, LLC, Decision denying plaintiff’s action for a preliminary injunction, Butler County Clerk of Courts, Sept. 6, 2021.

6. “Conscientious objection in medicine,” BMJ 2006 Feb 2. doi: 10.1136/bmj.332.7536.294.

If you have a gut feeling something is preventing you from losing as much weight as you would like to, you could be right.

Researchers found that the gut microbiome – the bacteria that help digest food and absorb nutrients in the intestines – can influence attempts at weight loss.

They identified genes within these bacteria that determine how quickly the bacteria grow, how well people can take advantage of nutrients in food, and whether starches and fiber, in particular, get broken down into sugars too quickly to aid weight loss.

“Some people have a harder time losing weight than others,” study author Sean Gibbons, PhD, told this news organization. “For example, some people are able to control their weight through basic lifestyle interventions, while others may not.”

Furthermore, it is difficult to predict which individuals will respond to changes in diet or exercise and who might require more intense strategies.

The study, which was published online September 14 in mSystems, a journal of the American Society for Microbiology, could bring us closer to an answer.

“We’ve identified specific genetic signatures in the gut microbiome that were predictive of weight loss response in a small cohort of patients following a healthy lifestyle intervention,” explained Dr. Gibbons, Washington Research Foundation distinguished investigator and assistant professor at the Institute for Systems Biology in Seattle.
 

Weight loss takes guts?

Differences in 31 functional genes emerged from the gut microbiome in 48 people who lost 1% or more of their weight each month compared with 57 others whose weight remained the same. These findings came from stool samples taken 6 to 12 months after people started a commercial weight loss coaching program.

In contrast, lead author Christian Diener, PhD, also of the Institute for Systems Biology, and colleagues found only one factor in the blood that differed between the weight loss and weight maintenance groups. (They specifically evaluated proteins associated with obesity in the blood and genetic data from stool samples in a subset of 25 participants.)

Their findings align with previous research showing different types of bacteria in the gut microbiome can affect the success of weight loss interventions, but they took it a step further to determine how this works.

“We know that the gut microbiome plays an important role in weight management and can also influence a response to weight loss interventions. However, specific gut microbiome features that can explain this observation in more detail are still to be discovered,” Hana Kahleova, MD, PhD, MBA, director of clinical research at the Physicians Committee for Responsible Medicine in Washington, D.C., told this news organization when asked for comment.
 

Good versus bad players

On the plus side, genes that help bacteria grow more rapidly were associated with weight loss. These bacteria take more of the nutrients in food for themselves, leaving less to go toward human weight gain compared with slower growing bacteria.

In fact, prior evidence points to a particular gut bacteria, Prevotella, as being beneficial for weight loss. “In our study,” Dr. Gibbons said, “we found that some of the fastest-growing microbes in the weight-loss responder group were from the genus Prevotella.”

On the other hand, bacteria that produce more enzymes to breakdown starches or fiber quickly into sugars, for example, were linked with making people more resistant to weight loss.

“By understanding these functional patterns, we may one day be able to engineer resistant microbiomes to be more permissive to weight loss,” Dr. Gibbons said.

Dr. Kahleova agreed. “These findings expand our understanding of the specific features of the gut microbiome that play a role in weight loss,” she said.
 

Moving beyond BMI

Interestingly, the researchers controlled for baseline body mass index (BMI) and other factors that could affect weight loss. People who start off with a higher BMI tend to lose more weight than others, a phenomenon known as ‘regression to the mean.” This factor confounded some earlier research, they noted.

“The vast majority of features associated with weight loss, independent of BMI, were functional genes within the gut metagenome,” Dr. Gibbons said.

“This tells us that the gut microbiome is an important modulator of weight loss, independent of your underlying metabolic health state, baseline diet, or BMI status.”

“This study described several metagenomic functional features that were associated with weight loss after controlling for potential confounders, such as age, sex, and baseline BMI,” Dr. Kahleova said. “These findings ... may help optimize the weight-loss protocols in future studies.”
 

Fecal microbiota transplants?

What do the findings mean for people willing to adjust their diet – or undergo a fecal transplant – to include more of the gut bacteria that facilitate weight loss?

It could be too soon for such interventions, Dr. Gibbons said. “It is still very difficult to rationally engineer your gut microbiome.”

“Interestingly, a recent study suggests that fecal transplants from a high-Prevotella donor may be able to flip low-Prevotella recipients to high-Prevotella,” Dr. Gibbons said.

More research is required, however, to understand whether or not these fecal microbial transplant-flipped individuals are also more capable of weight loss, he added.

Beyond that, “I can’t give any specific recommendations, other than that [people] should eat more fiber-rich, plant-based, whole foods and reduce their consumption of red meat. That’s well-supported.”

“Also, prepare your own meals, rather than relying on sugar and sodium-rich processed foods,” Dr. Gibbons said.

Dr. Gibbons and his team hope to validate their work in larger human studies “and perhaps develop clinical diagnostics or interventions for people trying to lose weight.”

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

If you have a gut feeling something is preventing you from losing as much weight as you would like to, you could be right.

Researchers found that the gut microbiome – the bacteria that help digest food and absorb nutrients in the intestines – can influence attempts at weight loss.

They identified genes within these bacteria that determine how quickly the bacteria grow, how well people can take advantage of nutrients in food, and whether starches and fiber, in particular, get broken down into sugars too quickly to aid weight loss.

“Some people have a harder time losing weight than others,” study author Sean Gibbons, PhD, told this news organization. “For example, some people are able to control their weight through basic lifestyle interventions, while others may not.”

Furthermore, it is difficult to predict which individuals will respond to changes in diet or exercise and who might require more intense strategies.

The study, which was published online September 14 in mSystems, a journal of the American Society for Microbiology, could bring us closer to an answer.

“We’ve identified specific genetic signatures in the gut microbiome that were predictive of weight loss response in a small cohort of patients following a healthy lifestyle intervention,” explained Dr. Gibbons, Washington Research Foundation distinguished investigator and assistant professor at the Institute for Systems Biology in Seattle.
 

Weight loss takes guts?

Differences in 31 functional genes emerged from the gut microbiome in 48 people who lost 1% or more of their weight each month compared with 57 others whose weight remained the same. These findings came from stool samples taken 6 to 12 months after people started a commercial weight loss coaching program.

In contrast, lead author Christian Diener, PhD, also of the Institute for Systems Biology, and colleagues found only one factor in the blood that differed between the weight loss and weight maintenance groups. (They specifically evaluated proteins associated with obesity in the blood and genetic data from stool samples in a subset of 25 participants.)

Their findings align with previous research showing different types of bacteria in the gut microbiome can affect the success of weight loss interventions, but they took it a step further to determine how this works.

“We know that the gut microbiome plays an important role in weight management and can also influence a response to weight loss interventions. However, specific gut microbiome features that can explain this observation in more detail are still to be discovered,” Hana Kahleova, MD, PhD, MBA, director of clinical research at the Physicians Committee for Responsible Medicine in Washington, D.C., told this news organization when asked for comment.
 

Good versus bad players

On the plus side, genes that help bacteria grow more rapidly were associated with weight loss. These bacteria take more of the nutrients in food for themselves, leaving less to go toward human weight gain compared with slower growing bacteria.

In fact, prior evidence points to a particular gut bacteria, Prevotella, as being beneficial for weight loss. “In our study,” Dr. Gibbons said, “we found that some of the fastest-growing microbes in the weight-loss responder group were from the genus Prevotella.”

On the other hand, bacteria that produce more enzymes to breakdown starches or fiber quickly into sugars, for example, were linked with making people more resistant to weight loss.

“By understanding these functional patterns, we may one day be able to engineer resistant microbiomes to be more permissive to weight loss,” Dr. Gibbons said.

Dr. Kahleova agreed. “These findings expand our understanding of the specific features of the gut microbiome that play a role in weight loss,” she said.
 

Moving beyond BMI

Interestingly, the researchers controlled for baseline body mass index (BMI) and other factors that could affect weight loss. People who start off with a higher BMI tend to lose more weight than others, a phenomenon known as ‘regression to the mean.” This factor confounded some earlier research, they noted.

“The vast majority of features associated with weight loss, independent of BMI, were functional genes within the gut metagenome,” Dr. Gibbons said.

“This tells us that the gut microbiome is an important modulator of weight loss, independent of your underlying metabolic health state, baseline diet, or BMI status.”

“This study described several metagenomic functional features that were associated with weight loss after controlling for potential confounders, such as age, sex, and baseline BMI,” Dr. Kahleova said. “These findings ... may help optimize the weight-loss protocols in future studies.”
 

Fecal microbiota transplants?

What do the findings mean for people willing to adjust their diet – or undergo a fecal transplant – to include more of the gut bacteria that facilitate weight loss?

It could be too soon for such interventions, Dr. Gibbons said. “It is still very difficult to rationally engineer your gut microbiome.”

“Interestingly, a recent study suggests that fecal transplants from a high-Prevotella donor may be able to flip low-Prevotella recipients to high-Prevotella,” Dr. Gibbons said.

More research is required, however, to understand whether or not these fecal microbial transplant-flipped individuals are also more capable of weight loss, he added.

Beyond that, “I can’t give any specific recommendations, other than that [people] should eat more fiber-rich, plant-based, whole foods and reduce their consumption of red meat. That’s well-supported.”

“Also, prepare your own meals, rather than relying on sugar and sodium-rich processed foods,” Dr. Gibbons said.

Dr. Gibbons and his team hope to validate their work in larger human studies “and perhaps develop clinical diagnostics or interventions for people trying to lose weight.”

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

If you have a gut feeling something is preventing you from losing as much weight as you would like to, you could be right.

Researchers found that the gut microbiome – the bacteria that help digest food and absorb nutrients in the intestines – can influence attempts at weight loss.

They identified genes within these bacteria that determine how quickly the bacteria grow, how well people can take advantage of nutrients in food, and whether starches and fiber, in particular, get broken down into sugars too quickly to aid weight loss.

“Some people have a harder time losing weight than others,” study author Sean Gibbons, PhD, told this news organization. “For example, some people are able to control their weight through basic lifestyle interventions, while others may not.”

Furthermore, it is difficult to predict which individuals will respond to changes in diet or exercise and who might require more intense strategies.

The study, which was published online September 14 in mSystems, a journal of the American Society for Microbiology, could bring us closer to an answer.

“We’ve identified specific genetic signatures in the gut microbiome that were predictive of weight loss response in a small cohort of patients following a healthy lifestyle intervention,” explained Dr. Gibbons, Washington Research Foundation distinguished investigator and assistant professor at the Institute for Systems Biology in Seattle.
 

Weight loss takes guts?

Differences in 31 functional genes emerged from the gut microbiome in 48 people who lost 1% or more of their weight each month compared with 57 others whose weight remained the same. These findings came from stool samples taken 6 to 12 months after people started a commercial weight loss coaching program.

In contrast, lead author Christian Diener, PhD, also of the Institute for Systems Biology, and colleagues found only one factor in the blood that differed between the weight loss and weight maintenance groups. (They specifically evaluated proteins associated with obesity in the blood and genetic data from stool samples in a subset of 25 participants.)

Their findings align with previous research showing different types of bacteria in the gut microbiome can affect the success of weight loss interventions, but they took it a step further to determine how this works.

“We know that the gut microbiome plays an important role in weight management and can also influence a response to weight loss interventions. However, specific gut microbiome features that can explain this observation in more detail are still to be discovered,” Hana Kahleova, MD, PhD, MBA, director of clinical research at the Physicians Committee for Responsible Medicine in Washington, D.C., told this news organization when asked for comment.
 

Good versus bad players

On the plus side, genes that help bacteria grow more rapidly were associated with weight loss. These bacteria take more of the nutrients in food for themselves, leaving less to go toward human weight gain compared with slower growing bacteria.

In fact, prior evidence points to a particular gut bacteria, Prevotella, as being beneficial for weight loss. “In our study,” Dr. Gibbons said, “we found that some of the fastest-growing microbes in the weight-loss responder group were from the genus Prevotella.”

On the other hand, bacteria that produce more enzymes to breakdown starches or fiber quickly into sugars, for example, were linked with making people more resistant to weight loss.

“By understanding these functional patterns, we may one day be able to engineer resistant microbiomes to be more permissive to weight loss,” Dr. Gibbons said.

Dr. Kahleova agreed. “These findings expand our understanding of the specific features of the gut microbiome that play a role in weight loss,” she said.
 

Moving beyond BMI

Interestingly, the researchers controlled for baseline body mass index (BMI) and other factors that could affect weight loss. People who start off with a higher BMI tend to lose more weight than others, a phenomenon known as ‘regression to the mean.” This factor confounded some earlier research, they noted.

“The vast majority of features associated with weight loss, independent of BMI, were functional genes within the gut metagenome,” Dr. Gibbons said.

“This tells us that the gut microbiome is an important modulator of weight loss, independent of your underlying metabolic health state, baseline diet, or BMI status.”

“This study described several metagenomic functional features that were associated with weight loss after controlling for potential confounders, such as age, sex, and baseline BMI,” Dr. Kahleova said. “These findings ... may help optimize the weight-loss protocols in future studies.”
 

Fecal microbiota transplants?

What do the findings mean for people willing to adjust their diet – or undergo a fecal transplant – to include more of the gut bacteria that facilitate weight loss?

It could be too soon for such interventions, Dr. Gibbons said. “It is still very difficult to rationally engineer your gut microbiome.”

“Interestingly, a recent study suggests that fecal transplants from a high-Prevotella donor may be able to flip low-Prevotella recipients to high-Prevotella,” Dr. Gibbons said.

More research is required, however, to understand whether or not these fecal microbial transplant-flipped individuals are also more capable of weight loss, he added.

Beyond that, “I can’t give any specific recommendations, other than that [people] should eat more fiber-rich, plant-based, whole foods and reduce their consumption of red meat. That’s well-supported.”

“Also, prepare your own meals, rather than relying on sugar and sodium-rich processed foods,” Dr. Gibbons said.

Dr. Gibbons and his team hope to validate their work in larger human studies “and perhaps develop clinical diagnostics or interventions for people trying to lose weight.”

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

The use of gonadotropin-releasing hormone agonists has a negative effect on bone mass in transgender youth, according to data from 172 individuals.

The onset of puberty and pubertal hormones contributes to the development of bone mass and body composition in adolescence, wrote Behdad Navabi, MD, and colleagues at Children’s Hospital of Eastern Ontario, Canada. Although the safety and efficacy of gonadotropin-releasing hormone agonists (GnRHa) has been described in short-term studies of youth with gender dysphoria, concerns persist about suppression of bone mass accrual from extended use of GnRHas in this population, they noted.

In a study published in Pediatrics, the researchers reviewed data from 172 youth younger than 18 years of age who were treated with GNRHa and underwent at least one baseline dual-energy radiograph absorptiometry (DXA) measurement between January 2006 and April 2017 at a single center. The standard treatment protocol started with three doses of 7.5 mg leuprolide acetate, given intramuscularly every 4 weeks, followed by 11.25 mg intramuscularly every 12 weeks after puberty suppression was confirmed both clinically and biochemically. Areal bone mineral density (aBMD) measurement z scores were based on birth-assigned sex, age, and ethnicity, and assessed at baseline and every 12 months. In addition, volumetric bone mineral density was calculated as bone mineral apparent density (BMAD) at the lower spine, and the z score based on age-matched, birth-assigned gender BMAD.

Overall, 55.2% of the youth were vitamin D deficient or insufficient at baseline, but 87.3% were sufficient by the time of a third follow-up visit after treatment with 1,000-2,000 IU of vitamin D daily; no cases of vitamin D toxicity were reported.

At baseline, transgender females had lower z scores for the LS aBMD and BMAD compared to transgender males, reflecting a difference seen in previous studies of transgender youth and adult females, the researchers noted.

The researchers analyzed pre- and posttreatment DXA data in a subgroup of 36 transgender females and 80 transgender males to identify any changes associated with GnRHa. The average time between the DXA scans was 407 days. In this population, aBMD z scores at the lower lumbar spine (LS), left total hip (LTH), and total body less head (TBLH) decreased significantly from baseline in transgender males and females.

Among transgender males, LS bone mineral apparent density (BMAD) z scores also decreased significantly from baseline, but no such change occurred among transgender females. The most significant decrease in z scores occurred in the LS aBMD and BMAD of transgender males, with changes that reflect findings from previous studies and may be explained by decreased estrogen, the researchers wrote.

In terms of body composition, no significant changes occurred in body mass index z score from baseline to follow-up in transgender males or females, the researchers noted, and changes in both gynoid and android fat percentages were consistent with the individuals’ affirmed genders. No vertebral fractures were detected.

However, GnRHa was significantly associated with a decrease in total body fat percentage and a decrease in lean body mass (LBM) in transgender females.

The study findings were limited by several factors, including the lack of consistent baseline physical activity records, and limited analysis at follow-up of the possible role of physical activity in bone health and body composition, the researchers noted. However, the results were strengthened by the relatively large study population with baseline assessments, and by the pre- and posttreatment analysis, they added.

“Evidence on GnRHa-associated changes in body composition and BMD will help health care professionals involved in the care of youth with GD [gender dysphoria] to counsel appropriately and optimize their bone health,” the researchers said. “Given the absence of vertebral fractures detected in those with significant decreases in their LS z scores, the significance of BMD effects of GnRHa in transgender youth needs further study, as well as whether future spine radiographs are needed on the basis of BMD trajectory,” they concluded.
 

Balance bone health concerns with potential benefits

The effect of estrogen and testosterone on bone geometry in puberty varies, and the increase in the use of GnRHa as part of a multidisciplinary gender transition plan makes research on the skeletal impact of this therapy in transgender youth a top priority, Laura K. Bachrach, MD, of Stanford (Calif.) University, and Catherine M. Gordon of Harvard Medical School, Boston, wrote in an accompanying editorial.

The decrease in areal bone mineral density and in bone mineral apparent density (BMAD) z scores in the current study is not unexpected, but the key question is how much bone density recovers once the suppression therapy ends and transgender sex steroid use begins, they said. “Follow-up studies of young adults treated with GnRHa for precocious puberty in childhood are reassuring,” they wrote. “It is premature, however, to extrapolate from these findings to transgender youth,” because the impact of gender-affirming sex steroid therapy on the skeleton at older ages and stages of maturity are unclear, they emphasized.

In the absence of definitive answers, the editorial authors advised clinicians treating youth with gender dysphoria to provide a balanced view of the risks and benefits of hormone therapy, and encourage adequate intake of dietary vitamin D and calcium, along with weight-bearing physical activity, to promote general bone health. “Transgender teenagers and their parents should be reassured that some recovery from decreases in aBMD during pubertal suppression with GnRHa is likely,” the authors noted. Bone health should be monitored throughout all stages of treatment in transgender youth, but concerns about transient bone loss should not discourage gender transition therapy, they emphasized. “In this patient group, providing a pause in pubertal development offers a life-changing and, for some, a life-saving intervention,” they concluded.
 

Comparison to cisgender controls would add value

“This study is important because one of the major side effects of GnRH agonists is decreased bone density, especially the longer that patients are on them,” M. Brett Cooper, MD, of UT Southwestern Medical Center, said in an interview. The findings add to existing data to underscore the importance of screening for low bone density and low vitamin D levels, Dr. Cooper added.

Dr. Cooper said that he was not surprised by the study findings. “I think that this study supported what clinicians already knew, which is that GnRH agonists do potentially cause a decline in bone mineral density and thus, you need to support these patients as best you can with calcium, vitamin D, and weight-bearing exercise,” he noted.

Dr. Cooper emphasized two main take-home points from the study. “First, clinicians who prescribe GnRH agonists need to ensure that they are checking bone density and vitamin D measurements, and then optimizing these appropriately,” he said. “Second, when a bone density is found to be low or a vitamin level is low, clinicians need to ensure that they are monitored and treated appropriately.” Clinicians need to use these data when deciding when to start gender-affirming hormones so their patients have the best chance to recover bone density, he added.

“I think one confounding factor on this study is the ranges they used for vitamin D deficiency,” Dr. Cooper noted. “This study was done in Canada, and the scale used was in nmol/L, while most labs in the U.S. use ng/mL,” he said. “Most pediatric and adolescent societies in the United States use < 20 ng/mL as an indicator of vitamin D deficient and between 20 and 29 ng/mL as insufficient,” he explained, citing the position statement on recommended vitamin D intake for adolescents published by The Society for Adolescent Health and Medicine. In this study, the results converted to < 12 ng/mL as deficient and between 12 and 20 ng/mL as insufficient, respectively, on the U.S. scale, said Dr. Cooper.

“Therefore, I can see that there are cases where someone may have been labeled vitamin D insufficient in this study using their range, whereas in the U.S. these patients would be labeled as vitamin D deficient and treated with higher-dose supplementation,” he said. In addition, individuals with levels between 20 ng/mL and 29 ng/mL in the U.S. would still be treated with vitamin D supplementation, “whereas in their study those individuals would have been labeled as normal,” he noted.

As for future research, it would be useful to study whether bone mass in transgender young people differs from age- and gender-matched controls who are not gender diverse (cisgender), Dr. Cooper added. “It may be possible that the youth in this study are not different from their peers and maybe the GnRH agonist is not the culprit,” he said.

The study received no outside funding. The researchers, editorial authors, and Dr. Cooper had no financial conflicts to disclose.

The use of gonadotropin-releasing hormone agonists has a negative effect on bone mass in transgender youth, according to data from 172 individuals.

The onset of puberty and pubertal hormones contributes to the development of bone mass and body composition in adolescence, wrote Behdad Navabi, MD, and colleagues at Children’s Hospital of Eastern Ontario, Canada. Although the safety and efficacy of gonadotropin-releasing hormone agonists (GnRHa) has been described in short-term studies of youth with gender dysphoria, concerns persist about suppression of bone mass accrual from extended use of GnRHas in this population, they noted.

In a study published in Pediatrics, the researchers reviewed data from 172 youth younger than 18 years of age who were treated with GNRHa and underwent at least one baseline dual-energy radiograph absorptiometry (DXA) measurement between January 2006 and April 2017 at a single center. The standard treatment protocol started with three doses of 7.5 mg leuprolide acetate, given intramuscularly every 4 weeks, followed by 11.25 mg intramuscularly every 12 weeks after puberty suppression was confirmed both clinically and biochemically. Areal bone mineral density (aBMD) measurement z scores were based on birth-assigned sex, age, and ethnicity, and assessed at baseline and every 12 months. In addition, volumetric bone mineral density was calculated as bone mineral apparent density (BMAD) at the lower spine, and the z score based on age-matched, birth-assigned gender BMAD.

Overall, 55.2% of the youth were vitamin D deficient or insufficient at baseline, but 87.3% were sufficient by the time of a third follow-up visit after treatment with 1,000-2,000 IU of vitamin D daily; no cases of vitamin D toxicity were reported.

At baseline, transgender females had lower z scores for the LS aBMD and BMAD compared to transgender males, reflecting a difference seen in previous studies of transgender youth and adult females, the researchers noted.

The researchers analyzed pre- and posttreatment DXA data in a subgroup of 36 transgender females and 80 transgender males to identify any changes associated with GnRHa. The average time between the DXA scans was 407 days. In this population, aBMD z scores at the lower lumbar spine (LS), left total hip (LTH), and total body less head (TBLH) decreased significantly from baseline in transgender males and females.

Among transgender males, LS bone mineral apparent density (BMAD) z scores also decreased significantly from baseline, but no such change occurred among transgender females. The most significant decrease in z scores occurred in the LS aBMD and BMAD of transgender males, with changes that reflect findings from previous studies and may be explained by decreased estrogen, the researchers wrote.

In terms of body composition, no significant changes occurred in body mass index z score from baseline to follow-up in transgender males or females, the researchers noted, and changes in both gynoid and android fat percentages were consistent with the individuals’ affirmed genders. No vertebral fractures were detected.

However, GnRHa was significantly associated with a decrease in total body fat percentage and a decrease in lean body mass (LBM) in transgender females.

The study findings were limited by several factors, including the lack of consistent baseline physical activity records, and limited analysis at follow-up of the possible role of physical activity in bone health and body composition, the researchers noted. However, the results were strengthened by the relatively large study population with baseline assessments, and by the pre- and posttreatment analysis, they added.

“Evidence on GnRHa-associated changes in body composition and BMD will help health care professionals involved in the care of youth with GD [gender dysphoria] to counsel appropriately and optimize their bone health,” the researchers said. “Given the absence of vertebral fractures detected in those with significant decreases in their LS z scores, the significance of BMD effects of GnRHa in transgender youth needs further study, as well as whether future spine radiographs are needed on the basis of BMD trajectory,” they concluded.
 

Balance bone health concerns with potential benefits

The effect of estrogen and testosterone on bone geometry in puberty varies, and the increase in the use of GnRHa as part of a multidisciplinary gender transition plan makes research on the skeletal impact of this therapy in transgender youth a top priority, Laura K. Bachrach, MD, of Stanford (Calif.) University, and Catherine M. Gordon of Harvard Medical School, Boston, wrote in an accompanying editorial.

The decrease in areal bone mineral density and in bone mineral apparent density (BMAD) z scores in the current study is not unexpected, but the key question is how much bone density recovers once the suppression therapy ends and transgender sex steroid use begins, they said. “Follow-up studies of young adults treated with GnRHa for precocious puberty in childhood are reassuring,” they wrote. “It is premature, however, to extrapolate from these findings to transgender youth,” because the impact of gender-affirming sex steroid therapy on the skeleton at older ages and stages of maturity are unclear, they emphasized.

In the absence of definitive answers, the editorial authors advised clinicians treating youth with gender dysphoria to provide a balanced view of the risks and benefits of hormone therapy, and encourage adequate intake of dietary vitamin D and calcium, along with weight-bearing physical activity, to promote general bone health. “Transgender teenagers and their parents should be reassured that some recovery from decreases in aBMD during pubertal suppression with GnRHa is likely,” the authors noted. Bone health should be monitored throughout all stages of treatment in transgender youth, but concerns about transient bone loss should not discourage gender transition therapy, they emphasized. “In this patient group, providing a pause in pubertal development offers a life-changing and, for some, a life-saving intervention,” they concluded.
 

Comparison to cisgender controls would add value

“This study is important because one of the major side effects of GnRH agonists is decreased bone density, especially the longer that patients are on them,” M. Brett Cooper, MD, of UT Southwestern Medical Center, said in an interview. The findings add to existing data to underscore the importance of screening for low bone density and low vitamin D levels, Dr. Cooper added.

Dr. Cooper said that he was not surprised by the study findings. “I think that this study supported what clinicians already knew, which is that GnRH agonists do potentially cause a decline in bone mineral density and thus, you need to support these patients as best you can with calcium, vitamin D, and weight-bearing exercise,” he noted.

Dr. Cooper emphasized two main take-home points from the study. “First, clinicians who prescribe GnRH agonists need to ensure that they are checking bone density and vitamin D measurements, and then optimizing these appropriately,” he said. “Second, when a bone density is found to be low or a vitamin level is low, clinicians need to ensure that they are monitored and treated appropriately.” Clinicians need to use these data when deciding when to start gender-affirming hormones so their patients have the best chance to recover bone density, he added.

“I think one confounding factor on this study is the ranges they used for vitamin D deficiency,” Dr. Cooper noted. “This study was done in Canada, and the scale used was in nmol/L, while most labs in the U.S. use ng/mL,” he said. “Most pediatric and adolescent societies in the United States use < 20 ng/mL as an indicator of vitamin D deficient and between 20 and 29 ng/mL as insufficient,” he explained, citing the position statement on recommended vitamin D intake for adolescents published by The Society for Adolescent Health and Medicine. In this study, the results converted to < 12 ng/mL as deficient and between 12 and 20 ng/mL as insufficient, respectively, on the U.S. scale, said Dr. Cooper.

“Therefore, I can see that there are cases where someone may have been labeled vitamin D insufficient in this study using their range, whereas in the U.S. these patients would be labeled as vitamin D deficient and treated with higher-dose supplementation,” he said. In addition, individuals with levels between 20 ng/mL and 29 ng/mL in the U.S. would still be treated with vitamin D supplementation, “whereas in their study those individuals would have been labeled as normal,” he noted.

As for future research, it would be useful to study whether bone mass in transgender young people differs from age- and gender-matched controls who are not gender diverse (cisgender), Dr. Cooper added. “It may be possible that the youth in this study are not different from their peers and maybe the GnRH agonist is not the culprit,” he said.

The study received no outside funding. The researchers, editorial authors, and Dr. Cooper had no financial conflicts to disclose.

The use of gonadotropin-releasing hormone agonists has a negative effect on bone mass in transgender youth, according to data from 172 individuals.

The onset of puberty and pubertal hormones contributes to the development of bone mass and body composition in adolescence, wrote Behdad Navabi, MD, and colleagues at Children’s Hospital of Eastern Ontario, Canada. Although the safety and efficacy of gonadotropin-releasing hormone agonists (GnRHa) has been described in short-term studies of youth with gender dysphoria, concerns persist about suppression of bone mass accrual from extended use of GnRHas in this population, they noted.

In a study published in Pediatrics, the researchers reviewed data from 172 youth younger than 18 years of age who were treated with GNRHa and underwent at least one baseline dual-energy radiograph absorptiometry (DXA) measurement between January 2006 and April 2017 at a single center. The standard treatment protocol started with three doses of 7.5 mg leuprolide acetate, given intramuscularly every 4 weeks, followed by 11.25 mg intramuscularly every 12 weeks after puberty suppression was confirmed both clinically and biochemically. Areal bone mineral density (aBMD) measurement z scores were based on birth-assigned sex, age, and ethnicity, and assessed at baseline and every 12 months. In addition, volumetric bone mineral density was calculated as bone mineral apparent density (BMAD) at the lower spine, and the z score based on age-matched, birth-assigned gender BMAD.

Overall, 55.2% of the youth were vitamin D deficient or insufficient at baseline, but 87.3% were sufficient by the time of a third follow-up visit after treatment with 1,000-2,000 IU of vitamin D daily; no cases of vitamin D toxicity were reported.

At baseline, transgender females had lower z scores for the LS aBMD and BMAD compared to transgender males, reflecting a difference seen in previous studies of transgender youth and adult females, the researchers noted.

The researchers analyzed pre- and posttreatment DXA data in a subgroup of 36 transgender females and 80 transgender males to identify any changes associated with GnRHa. The average time between the DXA scans was 407 days. In this population, aBMD z scores at the lower lumbar spine (LS), left total hip (LTH), and total body less head (TBLH) decreased significantly from baseline in transgender males and females.

Among transgender males, LS bone mineral apparent density (BMAD) z scores also decreased significantly from baseline, but no such change occurred among transgender females. The most significant decrease in z scores occurred in the LS aBMD and BMAD of transgender males, with changes that reflect findings from previous studies and may be explained by decreased estrogen, the researchers wrote.

In terms of body composition, no significant changes occurred in body mass index z score from baseline to follow-up in transgender males or females, the researchers noted, and changes in both gynoid and android fat percentages were consistent with the individuals’ affirmed genders. No vertebral fractures were detected.

However, GnRHa was significantly associated with a decrease in total body fat percentage and a decrease in lean body mass (LBM) in transgender females.

The study findings were limited by several factors, including the lack of consistent baseline physical activity records, and limited analysis at follow-up of the possible role of physical activity in bone health and body composition, the researchers noted. However, the results were strengthened by the relatively large study population with baseline assessments, and by the pre- and posttreatment analysis, they added.

“Evidence on GnRHa-associated changes in body composition and BMD will help health care professionals involved in the care of youth with GD [gender dysphoria] to counsel appropriately and optimize their bone health,” the researchers said. “Given the absence of vertebral fractures detected in those with significant decreases in their LS z scores, the significance of BMD effects of GnRHa in transgender youth needs further study, as well as whether future spine radiographs are needed on the basis of BMD trajectory,” they concluded.
 

Balance bone health concerns with potential benefits

The effect of estrogen and testosterone on bone geometry in puberty varies, and the increase in the use of GnRHa as part of a multidisciplinary gender transition plan makes research on the skeletal impact of this therapy in transgender youth a top priority, Laura K. Bachrach, MD, of Stanford (Calif.) University, and Catherine M. Gordon of Harvard Medical School, Boston, wrote in an accompanying editorial.

The decrease in areal bone mineral density and in bone mineral apparent density (BMAD) z scores in the current study is not unexpected, but the key question is how much bone density recovers once the suppression therapy ends and transgender sex steroid use begins, they said. “Follow-up studies of young adults treated with GnRHa for precocious puberty in childhood are reassuring,” they wrote. “It is premature, however, to extrapolate from these findings to transgender youth,” because the impact of gender-affirming sex steroid therapy on the skeleton at older ages and stages of maturity are unclear, they emphasized.

In the absence of definitive answers, the editorial authors advised clinicians treating youth with gender dysphoria to provide a balanced view of the risks and benefits of hormone therapy, and encourage adequate intake of dietary vitamin D and calcium, along with weight-bearing physical activity, to promote general bone health. “Transgender teenagers and their parents should be reassured that some recovery from decreases in aBMD during pubertal suppression with GnRHa is likely,” the authors noted. Bone health should be monitored throughout all stages of treatment in transgender youth, but concerns about transient bone loss should not discourage gender transition therapy, they emphasized. “In this patient group, providing a pause in pubertal development offers a life-changing and, for some, a life-saving intervention,” they concluded.
 

Comparison to cisgender controls would add value

“This study is important because one of the major side effects of GnRH agonists is decreased bone density, especially the longer that patients are on them,” M. Brett Cooper, MD, of UT Southwestern Medical Center, said in an interview. The findings add to existing data to underscore the importance of screening for low bone density and low vitamin D levels, Dr. Cooper added.

Dr. Cooper said that he was not surprised by the study findings. “I think that this study supported what clinicians already knew, which is that GnRH agonists do potentially cause a decline in bone mineral density and thus, you need to support these patients as best you can with calcium, vitamin D, and weight-bearing exercise,” he noted.

Dr. Cooper emphasized two main take-home points from the study. “First, clinicians who prescribe GnRH agonists need to ensure that they are checking bone density and vitamin D measurements, and then optimizing these appropriately,” he said. “Second, when a bone density is found to be low or a vitamin level is low, clinicians need to ensure that they are monitored and treated appropriately.” Clinicians need to use these data when deciding when to start gender-affirming hormones so their patients have the best chance to recover bone density, he added.

“I think one confounding factor on this study is the ranges they used for vitamin D deficiency,” Dr. Cooper noted. “This study was done in Canada, and the scale used was in nmol/L, while most labs in the U.S. use ng/mL,” he said. “Most pediatric and adolescent societies in the United States use < 20 ng/mL as an indicator of vitamin D deficient and between 20 and 29 ng/mL as insufficient,” he explained, citing the position statement on recommended vitamin D intake for adolescents published by The Society for Adolescent Health and Medicine. In this study, the results converted to < 12 ng/mL as deficient and between 12 and 20 ng/mL as insufficient, respectively, on the U.S. scale, said Dr. Cooper.

“Therefore, I can see that there are cases where someone may have been labeled vitamin D insufficient in this study using their range, whereas in the U.S. these patients would be labeled as vitamin D deficient and treated with higher-dose supplementation,” he said. In addition, individuals with levels between 20 ng/mL and 29 ng/mL in the U.S. would still be treated with vitamin D supplementation, “whereas in their study those individuals would have been labeled as normal,” he noted.

As for future research, it would be useful to study whether bone mass in transgender young people differs from age- and gender-matched controls who are not gender diverse (cisgender), Dr. Cooper added. “It may be possible that the youth in this study are not different from their peers and maybe the GnRH agonist is not the culprit,” he said.

The study received no outside funding. The researchers, editorial authors, and Dr. Cooper had no financial conflicts to disclose.

Moderna has released new data that it said support the argument for COVID-19 booster shots – specifically showing that people who received a first shot of their mRNA vaccine a median of 13 months ago are more likely to experience a breakthrough infection compared to individuals who received a first shot a median of 8 months ago.

Geber86/Getty Images

The findings come from the ongoing phase 3 COVE clinical trial, the results of which the Food and Drug Administration considered in granting emergency use authorization for the vaccine. In the initial stage of the trial, people were randomly assigned to receive the company’s mRNA vaccine or placebo.

Participants in COVE who were immunized more recently were 36% less likely to experience a breakthrough infection, according to the analysis of the open-label extension of the study during which placebo participants could cross over and get immunized as well.  

The updated COVE trial data show that 88 breakthrough cases of COVID-19 occurred among 11,431 participants vaccinated between December 2020 and March 2021 (49.0 cases per 1,000 person-years).

In contrast, there were 162 breakthrough cases among 14,746 people vaccinated between July and October 2020 (77.1 cases per 1,000 person-years).

The breakthrough infections include 19 severe cases. Although not statically different, there was a trend toward fewer severe cases among the more recently vaccinated, at a rate of 3.3 per 1,000 person-years, compared with 6.2 per 1,000 person-years in the group vaccinated in 2020

The findings were posted as a preprint to the medRxiv server and have not yet been peer reviewed.

“The increased risk of breakthrough infections in COVE study participants who were vaccinated last year compared to more recently illustrates the impact of waning immunity and supports the need for a booster to maintain high levels of protection,” Moderna CEO Stéphane Bancel said in a company statement.

An FDA advisory committee is meeting Sept. 17 to look at the available evidence on boosters to help the agency decide whether the additional shots are warranted.

There is still a lot of debate in the medical community about the need for boosters. U.S. physicians and nurses are divided about the need for them and about how the country should prioritize its vaccine supplies, according to a Medscape poll of more than 1,700 clinicians that collected responses from Aug. 25 to Sept. 6, 2020.

The research was funded by Moderna, and also supported by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, and by the National Institute of Allergy and Infectious Diseases.

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

Moderna has released new data that it said support the argument for COVID-19 booster shots – specifically showing that people who received a first shot of their mRNA vaccine a median of 13 months ago are more likely to experience a breakthrough infection compared to individuals who received a first shot a median of 8 months ago.

Geber86/Getty Images

The findings come from the ongoing phase 3 COVE clinical trial, the results of which the Food and Drug Administration considered in granting emergency use authorization for the vaccine. In the initial stage of the trial, people were randomly assigned to receive the company’s mRNA vaccine or placebo.

Participants in COVE who were immunized more recently were 36% less likely to experience a breakthrough infection, according to the analysis of the open-label extension of the study during which placebo participants could cross over and get immunized as well.  

The updated COVE trial data show that 88 breakthrough cases of COVID-19 occurred among 11,431 participants vaccinated between December 2020 and March 2021 (49.0 cases per 1,000 person-years).

In contrast, there were 162 breakthrough cases among 14,746 people vaccinated between July and October 2020 (77.1 cases per 1,000 person-years).

The breakthrough infections include 19 severe cases. Although not statically different, there was a trend toward fewer severe cases among the more recently vaccinated, at a rate of 3.3 per 1,000 person-years, compared with 6.2 per 1,000 person-years in the group vaccinated in 2020

The findings were posted as a preprint to the medRxiv server and have not yet been peer reviewed.

“The increased risk of breakthrough infections in COVE study participants who were vaccinated last year compared to more recently illustrates the impact of waning immunity and supports the need for a booster to maintain high levels of protection,” Moderna CEO Stéphane Bancel said in a company statement.

An FDA advisory committee is meeting Sept. 17 to look at the available evidence on boosters to help the agency decide whether the additional shots are warranted.

There is still a lot of debate in the medical community about the need for boosters. U.S. physicians and nurses are divided about the need for them and about how the country should prioritize its vaccine supplies, according to a Medscape poll of more than 1,700 clinicians that collected responses from Aug. 25 to Sept. 6, 2020.

The research was funded by Moderna, and also supported by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, and by the National Institute of Allergy and Infectious Diseases.

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

Moderna has released new data that it said support the argument for COVID-19 booster shots – specifically showing that people who received a first shot of their mRNA vaccine a median of 13 months ago are more likely to experience a breakthrough infection compared to individuals who received a first shot a median of 8 months ago.

Geber86/Getty Images

The findings come from the ongoing phase 3 COVE clinical trial, the results of which the Food and Drug Administration considered in granting emergency use authorization for the vaccine. In the initial stage of the trial, people were randomly assigned to receive the company’s mRNA vaccine or placebo.

Participants in COVE who were immunized more recently were 36% less likely to experience a breakthrough infection, according to the analysis of the open-label extension of the study during which placebo participants could cross over and get immunized as well.  

The updated COVE trial data show that 88 breakthrough cases of COVID-19 occurred among 11,431 participants vaccinated between December 2020 and March 2021 (49.0 cases per 1,000 person-years).

In contrast, there were 162 breakthrough cases among 14,746 people vaccinated between July and October 2020 (77.1 cases per 1,000 person-years).

The breakthrough infections include 19 severe cases. Although not statically different, there was a trend toward fewer severe cases among the more recently vaccinated, at a rate of 3.3 per 1,000 person-years, compared with 6.2 per 1,000 person-years in the group vaccinated in 2020

The findings were posted as a preprint to the medRxiv server and have not yet been peer reviewed.

“The increased risk of breakthrough infections in COVE study participants who were vaccinated last year compared to more recently illustrates the impact of waning immunity and supports the need for a booster to maintain high levels of protection,” Moderna CEO Stéphane Bancel said in a company statement.

An FDA advisory committee is meeting Sept. 17 to look at the available evidence on boosters to help the agency decide whether the additional shots are warranted.

There is still a lot of debate in the medical community about the need for boosters. U.S. physicians and nurses are divided about the need for them and about how the country should prioritize its vaccine supplies, according to a Medscape poll of more than 1,700 clinicians that collected responses from Aug. 25 to Sept. 6, 2020.

The research was funded by Moderna, and also supported by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, and by the National Institute of Allergy and Infectious Diseases.

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

A preprint study finding that the Pfizer-BioNTech mRNA COVID vaccine is associated with an increased risk for cardiac adverse events in teenage boys has elicited a firestorm on Twitter. Although some people issued thoughtful critiques, others lobbed insults against the authors, and still others accused them of either being antivaccine or stoking the fires of the vaccine skeptic movement.

The controversy began soon after the study was posted online September 8 on medRxiv. The authors conclude that for boys, the risk for a cardiac adverse event or hospitalization after the second dose of the Pfizer mRNA vaccine was “considerably higher” than the 120-day risk for hospitalization for COVID-19, “even at times of peak disease prevalence.” This was especially true for those aged 12 to 15 years and even those with no underlying health conditions.

The conclusion – as well as the paper’s source, the Vaccine Adverse Event Reporting System (VAERS), and its methodology, modeled after the Centers for Disease Control and Prevention assessment of the database – did not sit well with many.

“Your methodology hugely overestimates risk, which many commentators who are specialists in the field have highlighted,” tweeted Deepti Gurdasani, senior lecturer in epidemiology at Queen Mary University of London. “Why make this claim when you must know it’s wrong?”

“The authors don’t know what they are doing and they are following their own ideology,” tweeted Boback Ziaeian, MD, PhD, assistant professor of medicine at the University of California, Los Angeles, in the cardiology division. Dr. Ziaeian also tweeted, “I believe the CDC is doing honest work and not dredging slop like you are.”

“Holy shit. Truly terrible methods in that paper,” tweeted Michael Mina, MD, PhD, an epidemiologist and immunologist at the Harvard School of Public Health, Boston, more bluntly.

Some pointed out that VAERS is often used by vaccine skeptics to spread misinformation. “‘Dumpster diving’ describes studies using #VAERS by authors (almost always antivaxxers) who don’t understand its limitations,” tweeted David Gorski, MD, PhD, the editor of Science-Based Medicine, who says in his Twitter bio that he “exposes quackery.”

Added Dr. Gorski: “Doctors fell into this trap with their study suggesting #CovidVaccine is more dangerous to children than #COVID19.”

Dr. Gorski said he did not think that the authors were antivaccine. But, he tweeted, “I’d argue that at least one of the authors (Stevenson) is grossly unqualified to analyze the data. Mandrola? Marginal. The other two *might* be qualified in public health/epi, but they clearly either had no clue about #VAERS limitations or didn’t take them seriously enough.” 

Two of the authors, John Mandrola, MD, a cardiac electrophysiologist who is also a columnist for Medscape, and Tracy Beth Hoeg, MD, PhD, an epidemiologist and sports medicine specialist, told this news organization that their estimates are not definitive, owing to the nature of the VAERS database.

“I want to emphasize that our signal is hypothesis-generating,” said Dr. Mandrola. “There’s obviously more research that needs to be done.” 

“I don’t think it should be used to establish a for-certain rate,” said Dr. Hoeg, about the study. “It’s not a perfect way of establishing what the rate of cardiac adverse events was, but it gives you an estimate, and generally with VAERS, it’s a significant underestimate.”

Both Dr. Hoeg and Dr. Mandrola said their analysis showed enough of a signal that it warranted a rush to publish. “We felt that it was super time-sensitive,” Dr. Mandrola said.
 

Vaccine risks versus COVID harm

The authors searched the VAERS system for children aged 12 to 17 years who had received one or two doses of an mRNA vaccine and had symptoms of myocarditis, pericarditis, myopericarditis, or chest pain, and also troponin levels available in the lab data.

Of the 257 patients they examined, 211 had peak troponin values available for analysis. All but one received the Pfizer vaccine. Results were stratified by age and sex.

The authors found that the rates of cardiac adverse events (CAEs) after dose 1 were 12.0 per million for 12- to 15-year-old boys and 8.2 per million for 16- and 17-year-old boys, compared with 0.0 per million and 2.0 per million for girls the same ages.

The estimates for the 12- to 15-year-old boys were 22% to 150% higher than what the CDC had previously reported.

After the second dose, the rate of CAEs for boys 12 to 15 years was 162.2 per million (143% to 280% higher than the CDC estimate) and for boys 16 and 17 years, it was 94.0 per million, or 30% to 40% higher than CDC estimate.

Dr. Mandrola said he and his colleagues found potentially more cases by using slightly broader search terms than those employed by the CDC but agreed with some critics that a limitation was that they did not call the reporting physicians, as is typical with CDC follow-up on VAERS reports.

The authors point to troponin levels as valid indicators of myocardial damage. Peak troponin levels exceeded 2 ng/mL in 71% of the 12- to 15-year-olds and 82% of 16- and 17-year-olds.

The study shows that for boys 12 to 15 years with no comorbidities, the risk for a CAE after the second dose would be 22.8 times higher than the risk for hospitalization for COVID-19 during periods of low disease burden, 6.0 times higher during periods of moderate transmission, and 4.3 times higher during periods of high transmission.

The authors acknowledge in the paper that their analysis “does not take into account any benefits the vaccine provides against transmission to others, long-term COVID-19 disease risk, or protection from nonsevere COVID-19 symptoms.”

Both Dr. Mandrola and Dr. Hoeg told this news organization that they are currently recalculating their estimates because of the rising numbers of pediatric hospitalizations from the Delta variant surge.
 

Paper rejected by journals

Dr. Hoeg said in an interview that the paper went through peer-review at three journals but was rejected by all three, for reasons that were not made clear.

She and the other authors incorporated the reviewers’ feedback at each turn and included all of their suggestions in the paper that was ultimately uploaded to medRxiv, said Dr. Hoeg.

They decided to put it out as a preprint after the U.S. Food and Drug Administration issued its data and then a warning on June 25 about myocarditis with use of the Pfizer vaccine in children 12 to 15 years of age.

The preprint study was picked up by some media outlets, including The Telegraph and The Guardian newspapers, and tweeted out by vaccine skeptics like Robert W. Malone, MD. 

Rep. Marjorie Taylor Greene (R-Georgia), an outspoken vaccine skeptic, tweeted out the Guardian story saying that the findings mean “there is every reason to stop the covid vaccine mandates.”

Dr. Gorski noted in tweets and in a blog post that one of the paper’s coauthors, Josh Stevenson, is part of Rational Ground, a group that supports the Great Barrington Declaration and is against lockdowns and mask mandates.

Mr. Stevenson did not disclose his affiliation in the paper, and Dr. Hoeg said in an interview that she was unaware of the group and Mr. Stevenson’s association with it and that she did not have the impression that he was altering the data to show any bias.

Both Dr. Mandrola and Dr. Hoeg said they are provaccine and that they were dismayed to find their work being used to support any agenda. “It’s very frustrating,” said Dr. Hoeg, adding that she understands that “when you publish research on a controversial topic, people are going to take it and use it for their agendas.”

Some on Twitter blamed the open and free-wheeling nature of preprints.

Harlan Krumholz, MD, SM, the Harold H. Hines, junior professor of medicine and public health at Yale University, New Haven, Conn., which oversees medRxiv, tweeted, “Do you get that the discussion about the preprint is exactly the purpose of #preprints. So that way when someone claims something, you can look at the source and experts can comment.”

But Dr. Ziaeian tweeted back, “Preprints like this one can be weaponized to stir anti-vaccine lies and damage public health.”

In turn, the Yale physician replied, “Unfortunately these days, almost anything can be weaponized, distorted, misunderstood.” Dr. Krumholz added: “There is no question that this preprint is worthy of deep vetting and discussion. But there is a #preprint artifact to examine.”
 

Measured support

Some clinicians signaled their support for open debate and the preprint’s findings.

“I’ve been very critical of preprints that are too quickly disseminated in the media, and this one is no exception,” tweeted Walid Gellad, MD, MPH, associate professor of medicine at the University of Pittsburgh. “On the other hand, I think the vitriol directed at these authors is wrong,” he added.

“Like it or not, the issue of myocarditis in kids is an issue. Other countries have made vaccination decisions because of this issue, not because they’re driven by some ideology,” he tweeted.

Dr. Gellad also notes that the FDA has estimated the risk could be as high as one in 5,000 and that the preprint numbers could actually be underestimates.

In a long thread, Frank Han, MD, an adult congenital and pediatric cardiologist at the University of Illinois, tweets that relying on the VAERS reports might be faulty and that advanced cardiac imaging – guided by strict criteria – is the best way to determine myocarditis. And, he tweeted, “Physician review of VAERS reports really matters.”

Dr. Han concluded that vaccination “trades in a significant risk with a much smaller risk. That’s what counts in the end.”

In a response, Dr. Mandrola called Han’s tweets “reasoned criticism of our analysis.” He adds that his and Dr. Hoeg’s study have limits, but “our point is not to avoid protecting kids, but how to do so most safely.”

Both Dr. Mandrola and Dr. Hoeg said they welcomed critiques, but they felt blindsided by the vehemence of some of the Twitter debate.

“Some of the vitriol was surprising,” Dr. Mandrola said. “I kind of have this naive notion that people would assume that we’re not bad people,” he added.

However, Dr. Mandrola is known on Twitter for sometimes being highly critical of other researchers’ work, referring to some studies as “howlers,” and has in the past called out others for citing those papers.

Dr. Hoeg said she found critiques about weaknesses in the methods to be helpful. But she said many tweets were “attacking us as people, or not really attacking anything about our study, but just attacking the finding,” which does not help anyone “figure out what we should do about the safety signal or how we can research it further.”

Said Dr. Mandrola: “Why would we just ignore that and go forward with two-shot vaccination as a mandate when other countries are looking at other strategies?”

He noted that the United Kingdom has announced that children 12 to 15 years of age should receive just one shot of the mRNA vaccines instead of two because of the risk for myocarditis. Sixteen- to 18-year-olds have already been advised to get only one dose.

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

A preprint study finding that the Pfizer-BioNTech mRNA COVID vaccine is associated with an increased risk for cardiac adverse events in teenage boys has elicited a firestorm on Twitter. Although some people issued thoughtful critiques, others lobbed insults against the authors, and still others accused them of either being antivaccine or stoking the fires of the vaccine skeptic movement.

The controversy began soon after the study was posted online September 8 on medRxiv. The authors conclude that for boys, the risk for a cardiac adverse event or hospitalization after the second dose of the Pfizer mRNA vaccine was “considerably higher” than the 120-day risk for hospitalization for COVID-19, “even at times of peak disease prevalence.” This was especially true for those aged 12 to 15 years and even those with no underlying health conditions.

The conclusion – as well as the paper’s source, the Vaccine Adverse Event Reporting System (VAERS), and its methodology, modeled after the Centers for Disease Control and Prevention assessment of the database – did not sit well with many.

“Your methodology hugely overestimates risk, which many commentators who are specialists in the field have highlighted,” tweeted Deepti Gurdasani, senior lecturer in epidemiology at Queen Mary University of London. “Why make this claim when you must know it’s wrong?”

“The authors don’t know what they are doing and they are following their own ideology,” tweeted Boback Ziaeian, MD, PhD, assistant professor of medicine at the University of California, Los Angeles, in the cardiology division. Dr. Ziaeian also tweeted, “I believe the CDC is doing honest work and not dredging slop like you are.”

“Holy shit. Truly terrible methods in that paper,” tweeted Michael Mina, MD, PhD, an epidemiologist and immunologist at the Harvard School of Public Health, Boston, more bluntly.

Some pointed out that VAERS is often used by vaccine skeptics to spread misinformation. “‘Dumpster diving’ describes studies using #VAERS by authors (almost always antivaxxers) who don’t understand its limitations,” tweeted David Gorski, MD, PhD, the editor of Science-Based Medicine, who says in his Twitter bio that he “exposes quackery.”

Added Dr. Gorski: “Doctors fell into this trap with their study suggesting #CovidVaccine is more dangerous to children than #COVID19.”

Dr. Gorski said he did not think that the authors were antivaccine. But, he tweeted, “I’d argue that at least one of the authors (Stevenson) is grossly unqualified to analyze the data. Mandrola? Marginal. The other two *might* be qualified in public health/epi, but they clearly either had no clue about #VAERS limitations or didn’t take them seriously enough.” 

Two of the authors, John Mandrola, MD, a cardiac electrophysiologist who is also a columnist for Medscape, and Tracy Beth Hoeg, MD, PhD, an epidemiologist and sports medicine specialist, told this news organization that their estimates are not definitive, owing to the nature of the VAERS database.

“I want to emphasize that our signal is hypothesis-generating,” said Dr. Mandrola. “There’s obviously more research that needs to be done.” 

“I don’t think it should be used to establish a for-certain rate,” said Dr. Hoeg, about the study. “It’s not a perfect way of establishing what the rate of cardiac adverse events was, but it gives you an estimate, and generally with VAERS, it’s a significant underestimate.”

Both Dr. Hoeg and Dr. Mandrola said their analysis showed enough of a signal that it warranted a rush to publish. “We felt that it was super time-sensitive,” Dr. Mandrola said.
 

Vaccine risks versus COVID harm

The authors searched the VAERS system for children aged 12 to 17 years who had received one or two doses of an mRNA vaccine and had symptoms of myocarditis, pericarditis, myopericarditis, or chest pain, and also troponin levels available in the lab data.

Of the 257 patients they examined, 211 had peak troponin values available for analysis. All but one received the Pfizer vaccine. Results were stratified by age and sex.

The authors found that the rates of cardiac adverse events (CAEs) after dose 1 were 12.0 per million for 12- to 15-year-old boys and 8.2 per million for 16- and 17-year-old boys, compared with 0.0 per million and 2.0 per million for girls the same ages.

The estimates for the 12- to 15-year-old boys were 22% to 150% higher than what the CDC had previously reported.

After the second dose, the rate of CAEs for boys 12 to 15 years was 162.2 per million (143% to 280% higher than the CDC estimate) and for boys 16 and 17 years, it was 94.0 per million, or 30% to 40% higher than CDC estimate.

Dr. Mandrola said he and his colleagues found potentially more cases by using slightly broader search terms than those employed by the CDC but agreed with some critics that a limitation was that they did not call the reporting physicians, as is typical with CDC follow-up on VAERS reports.

The authors point to troponin levels as valid indicators of myocardial damage. Peak troponin levels exceeded 2 ng/mL in 71% of the 12- to 15-year-olds and 82% of 16- and 17-year-olds.

The study shows that for boys 12 to 15 years with no comorbidities, the risk for a CAE after the second dose would be 22.8 times higher than the risk for hospitalization for COVID-19 during periods of low disease burden, 6.0 times higher during periods of moderate transmission, and 4.3 times higher during periods of high transmission.

The authors acknowledge in the paper that their analysis “does not take into account any benefits the vaccine provides against transmission to others, long-term COVID-19 disease risk, or protection from nonsevere COVID-19 symptoms.”

Both Dr. Mandrola and Dr. Hoeg told this news organization that they are currently recalculating their estimates because of the rising numbers of pediatric hospitalizations from the Delta variant surge.
 

Paper rejected by journals

Dr. Hoeg said in an interview that the paper went through peer-review at three journals but was rejected by all three, for reasons that were not made clear.

She and the other authors incorporated the reviewers’ feedback at each turn and included all of their suggestions in the paper that was ultimately uploaded to medRxiv, said Dr. Hoeg.

They decided to put it out as a preprint after the U.S. Food and Drug Administration issued its data and then a warning on June 25 about myocarditis with use of the Pfizer vaccine in children 12 to 15 years of age.

The preprint study was picked up by some media outlets, including The Telegraph and The Guardian newspapers, and tweeted out by vaccine skeptics like Robert W. Malone, MD. 

Rep. Marjorie Taylor Greene (R-Georgia), an outspoken vaccine skeptic, tweeted out the Guardian story saying that the findings mean “there is every reason to stop the covid vaccine mandates.”

Dr. Gorski noted in tweets and in a blog post that one of the paper’s coauthors, Josh Stevenson, is part of Rational Ground, a group that supports the Great Barrington Declaration and is against lockdowns and mask mandates.

Mr. Stevenson did not disclose his affiliation in the paper, and Dr. Hoeg said in an interview that she was unaware of the group and Mr. Stevenson’s association with it and that she did not have the impression that he was altering the data to show any bias.

Both Dr. Mandrola and Dr. Hoeg said they are provaccine and that they were dismayed to find their work being used to support any agenda. “It’s very frustrating,” said Dr. Hoeg, adding that she understands that “when you publish research on a controversial topic, people are going to take it and use it for their agendas.”

Some on Twitter blamed the open and free-wheeling nature of preprints.

Harlan Krumholz, MD, SM, the Harold H. Hines, junior professor of medicine and public health at Yale University, New Haven, Conn., which oversees medRxiv, tweeted, “Do you get that the discussion about the preprint is exactly the purpose of #preprints. So that way when someone claims something, you can look at the source and experts can comment.”

But Dr. Ziaeian tweeted back, “Preprints like this one can be weaponized to stir anti-vaccine lies and damage public health.”

In turn, the Yale physician replied, “Unfortunately these days, almost anything can be weaponized, distorted, misunderstood.” Dr. Krumholz added: “There is no question that this preprint is worthy of deep vetting and discussion. But there is a #preprint artifact to examine.”
 

Measured support

Some clinicians signaled their support for open debate and the preprint’s findings.

“I’ve been very critical of preprints that are too quickly disseminated in the media, and this one is no exception,” tweeted Walid Gellad, MD, MPH, associate professor of medicine at the University of Pittsburgh. “On the other hand, I think the vitriol directed at these authors is wrong,” he added.

“Like it or not, the issue of myocarditis in kids is an issue. Other countries have made vaccination decisions because of this issue, not because they’re driven by some ideology,” he tweeted.

Dr. Gellad also notes that the FDA has estimated the risk could be as high as one in 5,000 and that the preprint numbers could actually be underestimates.

In a long thread, Frank Han, MD, an adult congenital and pediatric cardiologist at the University of Illinois, tweets that relying on the VAERS reports might be faulty and that advanced cardiac imaging – guided by strict criteria – is the best way to determine myocarditis. And, he tweeted, “Physician review of VAERS reports really matters.”

Dr. Han concluded that vaccination “trades in a significant risk with a much smaller risk. That’s what counts in the end.”

In a response, Dr. Mandrola called Han’s tweets “reasoned criticism of our analysis.” He adds that his and Dr. Hoeg’s study have limits, but “our point is not to avoid protecting kids, but how to do so most safely.”

Both Dr. Mandrola and Dr. Hoeg said they welcomed critiques, but they felt blindsided by the vehemence of some of the Twitter debate.

“Some of the vitriol was surprising,” Dr. Mandrola said. “I kind of have this naive notion that people would assume that we’re not bad people,” he added.

However, Dr. Mandrola is known on Twitter for sometimes being highly critical of other researchers’ work, referring to some studies as “howlers,” and has in the past called out others for citing those papers.

Dr. Hoeg said she found critiques about weaknesses in the methods to be helpful. But she said many tweets were “attacking us as people, or not really attacking anything about our study, but just attacking the finding,” which does not help anyone “figure out what we should do about the safety signal or how we can research it further.”

Said Dr. Mandrola: “Why would we just ignore that and go forward with two-shot vaccination as a mandate when other countries are looking at other strategies?”

He noted that the United Kingdom has announced that children 12 to 15 years of age should receive just one shot of the mRNA vaccines instead of two because of the risk for myocarditis. Sixteen- to 18-year-olds have already been advised to get only one dose.

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

A preprint study finding that the Pfizer-BioNTech mRNA COVID vaccine is associated with an increased risk for cardiac adverse events in teenage boys has elicited a firestorm on Twitter. Although some people issued thoughtful critiques, others lobbed insults against the authors, and still others accused them of either being antivaccine or stoking the fires of the vaccine skeptic movement.

The controversy began soon after the study was posted online September 8 on medRxiv. The authors conclude that for boys, the risk for a cardiac adverse event or hospitalization after the second dose of the Pfizer mRNA vaccine was “considerably higher” than the 120-day risk for hospitalization for COVID-19, “even at times of peak disease prevalence.” This was especially true for those aged 12 to 15 years and even those with no underlying health conditions.

The conclusion – as well as the paper’s source, the Vaccine Adverse Event Reporting System (VAERS), and its methodology, modeled after the Centers for Disease Control and Prevention assessment of the database – did not sit well with many.

“Your methodology hugely overestimates risk, which many commentators who are specialists in the field have highlighted,” tweeted Deepti Gurdasani, senior lecturer in epidemiology at Queen Mary University of London. “Why make this claim when you must know it’s wrong?”

“The authors don’t know what they are doing and they are following their own ideology,” tweeted Boback Ziaeian, MD, PhD, assistant professor of medicine at the University of California, Los Angeles, in the cardiology division. Dr. Ziaeian also tweeted, “I believe the CDC is doing honest work and not dredging slop like you are.”

“Holy shit. Truly terrible methods in that paper,” tweeted Michael Mina, MD, PhD, an epidemiologist and immunologist at the Harvard School of Public Health, Boston, more bluntly.

Some pointed out that VAERS is often used by vaccine skeptics to spread misinformation. “‘Dumpster diving’ describes studies using #VAERS by authors (almost always antivaxxers) who don’t understand its limitations,” tweeted David Gorski, MD, PhD, the editor of Science-Based Medicine, who says in his Twitter bio that he “exposes quackery.”

Added Dr. Gorski: “Doctors fell into this trap with their study suggesting #CovidVaccine is more dangerous to children than #COVID19.”

Dr. Gorski said he did not think that the authors were antivaccine. But, he tweeted, “I’d argue that at least one of the authors (Stevenson) is grossly unqualified to analyze the data. Mandrola? Marginal. The other two *might* be qualified in public health/epi, but they clearly either had no clue about #VAERS limitations or didn’t take them seriously enough.” 

Two of the authors, John Mandrola, MD, a cardiac electrophysiologist who is also a columnist for Medscape, and Tracy Beth Hoeg, MD, PhD, an epidemiologist and sports medicine specialist, told this news organization that their estimates are not definitive, owing to the nature of the VAERS database.

“I want to emphasize that our signal is hypothesis-generating,” said Dr. Mandrola. “There’s obviously more research that needs to be done.” 

“I don’t think it should be used to establish a for-certain rate,” said Dr. Hoeg, about the study. “It’s not a perfect way of establishing what the rate of cardiac adverse events was, but it gives you an estimate, and generally with VAERS, it’s a significant underestimate.”

Both Dr. Hoeg and Dr. Mandrola said their analysis showed enough of a signal that it warranted a rush to publish. “We felt that it was super time-sensitive,” Dr. Mandrola said.
 

Vaccine risks versus COVID harm

The authors searched the VAERS system for children aged 12 to 17 years who had received one or two doses of an mRNA vaccine and had symptoms of myocarditis, pericarditis, myopericarditis, or chest pain, and also troponin levels available in the lab data.

Of the 257 patients they examined, 211 had peak troponin values available for analysis. All but one received the Pfizer vaccine. Results were stratified by age and sex.

The authors found that the rates of cardiac adverse events (CAEs) after dose 1 were 12.0 per million for 12- to 15-year-old boys and 8.2 per million for 16- and 17-year-old boys, compared with 0.0 per million and 2.0 per million for girls the same ages.

The estimates for the 12- to 15-year-old boys were 22% to 150% higher than what the CDC had previously reported.

After the second dose, the rate of CAEs for boys 12 to 15 years was 162.2 per million (143% to 280% higher than the CDC estimate) and for boys 16 and 17 years, it was 94.0 per million, or 30% to 40% higher than CDC estimate.

Dr. Mandrola said he and his colleagues found potentially more cases by using slightly broader search terms than those employed by the CDC but agreed with some critics that a limitation was that they did not call the reporting physicians, as is typical with CDC follow-up on VAERS reports.

The authors point to troponin levels as valid indicators of myocardial damage. Peak troponin levels exceeded 2 ng/mL in 71% of the 12- to 15-year-olds and 82% of 16- and 17-year-olds.

The study shows that for boys 12 to 15 years with no comorbidities, the risk for a CAE after the second dose would be 22.8 times higher than the risk for hospitalization for COVID-19 during periods of low disease burden, 6.0 times higher during periods of moderate transmission, and 4.3 times higher during periods of high transmission.

The authors acknowledge in the paper that their analysis “does not take into account any benefits the vaccine provides against transmission to others, long-term COVID-19 disease risk, or protection from nonsevere COVID-19 symptoms.”

Both Dr. Mandrola and Dr. Hoeg told this news organization that they are currently recalculating their estimates because of the rising numbers of pediatric hospitalizations from the Delta variant surge.
 

Paper rejected by journals

Dr. Hoeg said in an interview that the paper went through peer-review at three journals but was rejected by all three, for reasons that were not made clear.

She and the other authors incorporated the reviewers’ feedback at each turn and included all of their suggestions in the paper that was ultimately uploaded to medRxiv, said Dr. Hoeg.

They decided to put it out as a preprint after the U.S. Food and Drug Administration issued its data and then a warning on June 25 about myocarditis with use of the Pfizer vaccine in children 12 to 15 years of age.

The preprint study was picked up by some media outlets, including The Telegraph and The Guardian newspapers, and tweeted out by vaccine skeptics like Robert W. Malone, MD. 

Rep. Marjorie Taylor Greene (R-Georgia), an outspoken vaccine skeptic, tweeted out the Guardian story saying that the findings mean “there is every reason to stop the covid vaccine mandates.”

Dr. Gorski noted in tweets and in a blog post that one of the paper’s coauthors, Josh Stevenson, is part of Rational Ground, a group that supports the Great Barrington Declaration and is against lockdowns and mask mandates.

Mr. Stevenson did not disclose his affiliation in the paper, and Dr. Hoeg said in an interview that she was unaware of the group and Mr. Stevenson’s association with it and that she did not have the impression that he was altering the data to show any bias.

Both Dr. Mandrola and Dr. Hoeg said they are provaccine and that they were dismayed to find their work being used to support any agenda. “It’s very frustrating,” said Dr. Hoeg, adding that she understands that “when you publish research on a controversial topic, people are going to take it and use it for their agendas.”

Some on Twitter blamed the open and free-wheeling nature of preprints.

Harlan Krumholz, MD, SM, the Harold H. Hines, junior professor of medicine and public health at Yale University, New Haven, Conn., which oversees medRxiv, tweeted, “Do you get that the discussion about the preprint is exactly the purpose of #preprints. So that way when someone claims something, you can look at the source and experts can comment.”

But Dr. Ziaeian tweeted back, “Preprints like this one can be weaponized to stir anti-vaccine lies and damage public health.”

In turn, the Yale physician replied, “Unfortunately these days, almost anything can be weaponized, distorted, misunderstood.” Dr. Krumholz added: “There is no question that this preprint is worthy of deep vetting and discussion. But there is a #preprint artifact to examine.”
 

Measured support

Some clinicians signaled their support for open debate and the preprint’s findings.

“I’ve been very critical of preprints that are too quickly disseminated in the media, and this one is no exception,” tweeted Walid Gellad, MD, MPH, associate professor of medicine at the University of Pittsburgh. “On the other hand, I think the vitriol directed at these authors is wrong,” he added.

“Like it or not, the issue of myocarditis in kids is an issue. Other countries have made vaccination decisions because of this issue, not because they’re driven by some ideology,” he tweeted.

Dr. Gellad also notes that the FDA has estimated the risk could be as high as one in 5,000 and that the preprint numbers could actually be underestimates.

In a long thread, Frank Han, MD, an adult congenital and pediatric cardiologist at the University of Illinois, tweets that relying on the VAERS reports might be faulty and that advanced cardiac imaging – guided by strict criteria – is the best way to determine myocarditis. And, he tweeted, “Physician review of VAERS reports really matters.”

Dr. Han concluded that vaccination “trades in a significant risk with a much smaller risk. That’s what counts in the end.”

In a response, Dr. Mandrola called Han’s tweets “reasoned criticism of our analysis.” He adds that his and Dr. Hoeg’s study have limits, but “our point is not to avoid protecting kids, but how to do so most safely.”

Both Dr. Mandrola and Dr. Hoeg said they welcomed critiques, but they felt blindsided by the vehemence of some of the Twitter debate.

“Some of the vitriol was surprising,” Dr. Mandrola said. “I kind of have this naive notion that people would assume that we’re not bad people,” he added.

However, Dr. Mandrola is known on Twitter for sometimes being highly critical of other researchers’ work, referring to some studies as “howlers,” and has in the past called out others for citing those papers.

Dr. Hoeg said she found critiques about weaknesses in the methods to be helpful. But she said many tweets were “attacking us as people, or not really attacking anything about our study, but just attacking the finding,” which does not help anyone “figure out what we should do about the safety signal or how we can research it further.”

Said Dr. Mandrola: “Why would we just ignore that and go forward with two-shot vaccination as a mandate when other countries are looking at other strategies?”

He noted that the United Kingdom has announced that children 12 to 15 years of age should receive just one shot of the mRNA vaccines instead of two because of the risk for myocarditis. Sixteen- to 18-year-olds have already been advised to get only one dose.

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