Adolescent Medicine

Managing type 1 diabetes is never easy. But if you ask 16-year-old climbing star Katie Bone, she’ll tell you that she will never let this disease get in the way of her goals.

“My motto is the same one as Bethany Hamilton’s – the surfer who lost her arm in a shark attack: ‘I don’t need easy, I just need possible,” said Ms. Bone, who lives in Albuquerque and has been a competitive rock climber since she was 8 years old. “That really stuck with me.”

Just watching her compete on NBC’s hit reality show American Ninja Warrior in June is proof of that. Not only did the nationally ranked climber fly through the obstacles with grace and grit, but she proudly showed off her two monitoring devices: a glucose monitor on one arm and a tubeless insulin pump on the other.

“I specifically decided to keep my devices visible when I went on the show,” she said. “It’s part of my life, and I wanted to show that I’m not ashamed to wear medical devices.”

Still, it has been a long journey since Bone was diagnosed in 2017. She was just 11 years old at the time and had recently done a climbing competition when she started feeling ill.

“I didn’t perform well,” she said. “I needed to go to the bathroom a lot and felt really nauseous. Three days later, we ended up in urgent care.”

When her doctor first told her she had diabetes, she started crying.

“My grandma had type 1 and was extremely sick and died from complications,” she said. “That was all I knew about diabetes, and it was scary to think my life could be like that.”

But her outlook brightened when her doctor assured her that she could keep climbing.

“When I was told that I could keep competing, a switch flipped for me and I made a decision that nothing would hold me back,” she says.

But every day isn’t easy.

“It’s sometimes really hard to manage my diabetes during competitions,” she said. “When we climb, for example, we’re not allowed to have our phones, and I manage my [glucose monitor] through my phone. This means accommodations have to be made for me.”

And managing her diabetes can be unpredictable at times.

“If my blood sugar is low or high, I might be put last in a competition,” she said. “That messes up my warm-up and my mental game. It’s a never-ending battle.”

Ultimately, Ms. Bone’s goal is to inspire others and advocate for diabetes awareness. She says she’s been overwhelmed by viewer responses to her appearance on the show.

“I heard from so many parents and kids,” she said. “I want the world to know that wearing a pump on your arm only makes you more amazing.”

She also draws inspiration from others with diabetes.

“Everyone with this disease is a role model for me, since everyone is fighting their own battles,” she said. “Diabetes is different for everyone, and seeing how people can do what they do despite the diagnosis has been incredibly inspiring.”

For now, the rising high school junior plans to continue training and competing.

“My goal is to make the 2024 Olympic climbing team in Paris,” she said. “I’ve always wanted to compete in the Olympics since I was a little kid. Nothing can stop me.”

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

Managing type 1 diabetes is never easy. But if you ask 16-year-old climbing star Katie Bone, she’ll tell you that she will never let this disease get in the way of her goals.

“My motto is the same one as Bethany Hamilton’s – the surfer who lost her arm in a shark attack: ‘I don’t need easy, I just need possible,” said Ms. Bone, who lives in Albuquerque and has been a competitive rock climber since she was 8 years old. “That really stuck with me.”

Just watching her compete on NBC’s hit reality show American Ninja Warrior in June is proof of that. Not only did the nationally ranked climber fly through the obstacles with grace and grit, but she proudly showed off her two monitoring devices: a glucose monitor on one arm and a tubeless insulin pump on the other.

“I specifically decided to keep my devices visible when I went on the show,” she said. “It’s part of my life, and I wanted to show that I’m not ashamed to wear medical devices.”

Still, it has been a long journey since Bone was diagnosed in 2017. She was just 11 years old at the time and had recently done a climbing competition when she started feeling ill.

“I didn’t perform well,” she said. “I needed to go to the bathroom a lot and felt really nauseous. Three days later, we ended up in urgent care.”

When her doctor first told her she had diabetes, she started crying.

“My grandma had type 1 and was extremely sick and died from complications,” she said. “That was all I knew about diabetes, and it was scary to think my life could be like that.”

But her outlook brightened when her doctor assured her that she could keep climbing.

“When I was told that I could keep competing, a switch flipped for me and I made a decision that nothing would hold me back,” she says.

But every day isn’t easy.

“It’s sometimes really hard to manage my diabetes during competitions,” she said. “When we climb, for example, we’re not allowed to have our phones, and I manage my [glucose monitor] through my phone. This means accommodations have to be made for me.”

And managing her diabetes can be unpredictable at times.

“If my blood sugar is low or high, I might be put last in a competition,” she said. “That messes up my warm-up and my mental game. It’s a never-ending battle.”

Ultimately, Ms. Bone’s goal is to inspire others and advocate for diabetes awareness. She says she’s been overwhelmed by viewer responses to her appearance on the show.

“I heard from so many parents and kids,” she said. “I want the world to know that wearing a pump on your arm only makes you more amazing.”

She also draws inspiration from others with diabetes.

“Everyone with this disease is a role model for me, since everyone is fighting their own battles,” she said. “Diabetes is different for everyone, and seeing how people can do what they do despite the diagnosis has been incredibly inspiring.”

For now, the rising high school junior plans to continue training and competing.

“My goal is to make the 2024 Olympic climbing team in Paris,” she said. “I’ve always wanted to compete in the Olympics since I was a little kid. Nothing can stop me.”

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

Managing type 1 diabetes is never easy. But if you ask 16-year-old climbing star Katie Bone, she’ll tell you that she will never let this disease get in the way of her goals.

“My motto is the same one as Bethany Hamilton’s – the surfer who lost her arm in a shark attack: ‘I don’t need easy, I just need possible,” said Ms. Bone, who lives in Albuquerque and has been a competitive rock climber since she was 8 years old. “That really stuck with me.”

Just watching her compete on NBC’s hit reality show American Ninja Warrior in June is proof of that. Not only did the nationally ranked climber fly through the obstacles with grace and grit, but she proudly showed off her two monitoring devices: a glucose monitor on one arm and a tubeless insulin pump on the other.

“I specifically decided to keep my devices visible when I went on the show,” she said. “It’s part of my life, and I wanted to show that I’m not ashamed to wear medical devices.”

Still, it has been a long journey since Bone was diagnosed in 2017. She was just 11 years old at the time and had recently done a climbing competition when she started feeling ill.

“I didn’t perform well,” she said. “I needed to go to the bathroom a lot and felt really nauseous. Three days later, we ended up in urgent care.”

When her doctor first told her she had diabetes, she started crying.

“My grandma had type 1 and was extremely sick and died from complications,” she said. “That was all I knew about diabetes, and it was scary to think my life could be like that.”

But her outlook brightened when her doctor assured her that she could keep climbing.

“When I was told that I could keep competing, a switch flipped for me and I made a decision that nothing would hold me back,” she says.

But every day isn’t easy.

“It’s sometimes really hard to manage my diabetes during competitions,” she said. “When we climb, for example, we’re not allowed to have our phones, and I manage my [glucose monitor] through my phone. This means accommodations have to be made for me.”

And managing her diabetes can be unpredictable at times.

“If my blood sugar is low or high, I might be put last in a competition,” she said. “That messes up my warm-up and my mental game. It’s a never-ending battle.”

Ultimately, Ms. Bone’s goal is to inspire others and advocate for diabetes awareness. She says she’s been overwhelmed by viewer responses to her appearance on the show.

“I heard from so many parents and kids,” she said. “I want the world to know that wearing a pump on your arm only makes you more amazing.”

She also draws inspiration from others with diabetes.

“Everyone with this disease is a role model for me, since everyone is fighting their own battles,” she said. “Diabetes is different for everyone, and seeing how people can do what they do despite the diagnosis has been incredibly inspiring.”

For now, the rising high school junior plans to continue training and competing.

“My goal is to make the 2024 Olympic climbing team in Paris,” she said. “I’ve always wanted to compete in the Olympics since I was a little kid. Nothing can stop me.”

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

SACRAMENTO, CALIF. – Californians will decide in November whether to lock the right to abortion into the state constitution.

If they vote “yes” on Proposition 1, they will also lock in a right that has gotten less attention: The right to birth control.

Should the measure succeed, California would become one of the first states – if not the first – to create explicit constitutional rights to both abortion and contraception.

The lawmakers and activists behind the constitutional amendment said they hope to score a one-two punch: Protect abortion in California after the U.S. Supreme Court ended the federal constitutional right to abortion under Roe v. Wade, and get ahead of what they see as the next front in the reproductive rights fight: Birth control.

“The United States Supreme Court said that the privacy and liberty protections in the United States Constitution did not extend to abortion,” said UCLA law professor Cary Franklin, an expert in constitutional law and reproductive rights who has testified before the California legislature in support of the amendment. “If they said ‘no’ on abortion, they’re probably going to say ‘no’ on birth control because that has a similar history.”

In June, the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization ended the federal right to abortion and left states to regulate the service. In his concurring opinion, Justice Clarence Thomas said the court should revisit other cases that have created protections for Americans based on an implicit right to privacy in the U.S. Constitution, such as the 1965 case Griswold v. Connecticut, which established a federal right to contraception for married people, and which was later extended to unmarried people.

Some congressional Democrats are now trying to codify the right to contraception in federal law. In July, the U.S. House of Representatives passed the Right to Contraception Act, which would give patients the right to access and use contraception and providers the right to furnish it. But the bill has little chance of success in the U.S. Senate, where Republicans have already blocked it once.

Protecting access to contraception is popular with voters. A national poll from Morning Consult and Politico conducted in late July found that 75% of registered voters support a federal law that protects a right to birth control access.

California isn’t the only state where voters are considering reproductive rights in their constitutions.

On Aug. 2, Kansas voters decisively rejected a constitutional amendment that would have allowed state lawmakers to ban or dramatically restrict abortion. It failed by nearly 18 percentage points.

Kentucky voters will face a similar decision in November with a proposed constitutional amendment that would declare that the state’s constitutional right to privacy does not cover abortion.

Vermont is going in the opposite direction. Voters there will weigh a ballot measure in November that would add a right to “personal reproductive autonomy” to the state constitution, though it does not explicitly mention abortion or contraception. In Michigan, a proposed constitutional amendment that would guarantee a right to both abortion and contraception is expected to qualify for the November ballot.

In California, Proposition 1 would prevent the state from denying or interfering with “an individual’s reproductive freedom in their most intimate decisions, which includes their fundamental right to choose to have an abortion and their fundamental right to choose or refuse contraceptives.”

The proposed constitutional amendment doesn’t go into detail about what enshrining the right to contraception in the state constitution would mean.

California already has some of the strongest contraceptive-access laws in the country – and lawmakers are considering more proposals this year. For instance, state-regulated health plans must cover all Food and Drug Administration–approved contraception; pharmacists must dispense emergency contraception to anyone with a prescription, regardless of age; and pharmacists can prescribe birth control pills on the spot. State courts have also interpreted California’s constitution to include a right to privacy that covers reproductive health decisions.

The amendment, if adopted, could provide a new legal pathway for people to sue when they’re denied contraceptives, said Michele Goodwin, chancellor’s professor of law at the University of California, Irvine.

If a pharmacist refused to fill a birth control prescription or a cashier declined to ring up condoms, she said, customers could make a case that their rights had been violated.

Making the rights to abortion and contraception explicit in the state constitution – instead of relying on a right to privacy – would also protect against shifting political winds, said state Senate leader Toni Atkins (D–San Diego), who was the director of a women’s health clinic in the 1980s. Although California’s lawmakers and executive officers are solid supporters of abortion rights, she said, the composition of the legislature and courts’ interpretation of laws could change.

“I want to know for sure that that right is protected,” Ms. Atkins said at a legislative hearing in June. “We are protecting ourselves from future courts and future politicians.”

The amendment would solidify California’s role as a reproductive rights sanctuary as much of the country chips away at birth control availability, Ms. Goodwin added.

Experts said two forms of birth control that are vulnerable to restrictions in other states are intrauterine devices, or IUDs, and emergency contraception such as Plan B. These methods are often incorrectly conflated with abortion pills, which end a pregnancy instead of preventing it.

Nine states have laws that restrict emergency contraception – for example, by allowing pharmacies to refuse to dispense it or excluding it from state family planning programs – according to the Guttmacher Institute, a research organization that supports abortion rights. In Alabama and Louisiana this year, abortion opponents introduced legislation that would restrict or ban abortion, and would also apply to emergency contraception.

“We’re seeing an erosion of abortion access that is playing out in statehouses across the country that have and will continue to target contraceptive care as well,” said Audrey Sandusky, senior director of policy and communications for the National Family Planning and Reproductive Health Association.

Susan Arnall, vice president of California’s Right to Life League, said the proposed amendment is symbolic and merely echoes current laws. Ms. Arnall said the campaign is mostly about Democratic politicians trying to score political points.

“It just allows the pro-abort legislators to trumpet and give them talking points about how they’re doing something about the overturn of Roe v. Wade,” she said. “It is political virtue signaling. I don’t think it does much of anything else.”

Ms. Goodwin argues that the measure’s symbolism is significant and overdue. She pointed to the Civil War era, when enslaved people in Southern states could look to free states for spiritual hope and material help. “Symbolically, what that meant is a kind of beacon of hope, that those places did exist, where one’s humanity could be regarded,” Ms. Goodwin said.

But California’s reputation as a haven for contraceptive availability may not be fully warranted, said Dima Qato, PharmD, PhD, an associate professor at the University of Southern California School of Pharmacy. In her 2020 study of contraceptive access in Los Angeles County, which has some of the highest rates of teen and unintended pregnancy in the country, Dr. Qato found that only 10% of pharmacies surveyed offered pharmacist-prescribed birth control. Pharmacies in low-income and minority communities were the least likely to offer the service, Dr. Qato said, worsening disparities instead of solving them.

Dr. Qato supports the constitutional amendment but said California should focus on improving and enforcing the laws it already has.

“We don’t need more laws when we don’t address the root cause of a lack of effectiveness of these laws in these communities,” she said. “Lack of enforcement and accountability disproportionately impacts communities of color.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Rachel Bluth is a correspondent for California Healthline. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

SACRAMENTO, CALIF. – Californians will decide in November whether to lock the right to abortion into the state constitution.

If they vote “yes” on Proposition 1, they will also lock in a right that has gotten less attention: The right to birth control.

Should the measure succeed, California would become one of the first states – if not the first – to create explicit constitutional rights to both abortion and contraception.

The lawmakers and activists behind the constitutional amendment said they hope to score a one-two punch: Protect abortion in California after the U.S. Supreme Court ended the federal constitutional right to abortion under Roe v. Wade, and get ahead of what they see as the next front in the reproductive rights fight: Birth control.

“The United States Supreme Court said that the privacy and liberty protections in the United States Constitution did not extend to abortion,” said UCLA law professor Cary Franklin, an expert in constitutional law and reproductive rights who has testified before the California legislature in support of the amendment. “If they said ‘no’ on abortion, they’re probably going to say ‘no’ on birth control because that has a similar history.”

In June, the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization ended the federal right to abortion and left states to regulate the service. In his concurring opinion, Justice Clarence Thomas said the court should revisit other cases that have created protections for Americans based on an implicit right to privacy in the U.S. Constitution, such as the 1965 case Griswold v. Connecticut, which established a federal right to contraception for married people, and which was later extended to unmarried people.

Some congressional Democrats are now trying to codify the right to contraception in federal law. In July, the U.S. House of Representatives passed the Right to Contraception Act, which would give patients the right to access and use contraception and providers the right to furnish it. But the bill has little chance of success in the U.S. Senate, where Republicans have already blocked it once.

Protecting access to contraception is popular with voters. A national poll from Morning Consult and Politico conducted in late July found that 75% of registered voters support a federal law that protects a right to birth control access.

California isn’t the only state where voters are considering reproductive rights in their constitutions.

On Aug. 2, Kansas voters decisively rejected a constitutional amendment that would have allowed state lawmakers to ban or dramatically restrict abortion. It failed by nearly 18 percentage points.

Kentucky voters will face a similar decision in November with a proposed constitutional amendment that would declare that the state’s constitutional right to privacy does not cover abortion.

Vermont is going in the opposite direction. Voters there will weigh a ballot measure in November that would add a right to “personal reproductive autonomy” to the state constitution, though it does not explicitly mention abortion or contraception. In Michigan, a proposed constitutional amendment that would guarantee a right to both abortion and contraception is expected to qualify for the November ballot.

In California, Proposition 1 would prevent the state from denying or interfering with “an individual’s reproductive freedom in their most intimate decisions, which includes their fundamental right to choose to have an abortion and their fundamental right to choose or refuse contraceptives.”

The proposed constitutional amendment doesn’t go into detail about what enshrining the right to contraception in the state constitution would mean.

California already has some of the strongest contraceptive-access laws in the country – and lawmakers are considering more proposals this year. For instance, state-regulated health plans must cover all Food and Drug Administration–approved contraception; pharmacists must dispense emergency contraception to anyone with a prescription, regardless of age; and pharmacists can prescribe birth control pills on the spot. State courts have also interpreted California’s constitution to include a right to privacy that covers reproductive health decisions.

The amendment, if adopted, could provide a new legal pathway for people to sue when they’re denied contraceptives, said Michele Goodwin, chancellor’s professor of law at the University of California, Irvine.

If a pharmacist refused to fill a birth control prescription or a cashier declined to ring up condoms, she said, customers could make a case that their rights had been violated.

Making the rights to abortion and contraception explicit in the state constitution – instead of relying on a right to privacy – would also protect against shifting political winds, said state Senate leader Toni Atkins (D–San Diego), who was the director of a women’s health clinic in the 1980s. Although California’s lawmakers and executive officers are solid supporters of abortion rights, she said, the composition of the legislature and courts’ interpretation of laws could change.

“I want to know for sure that that right is protected,” Ms. Atkins said at a legislative hearing in June. “We are protecting ourselves from future courts and future politicians.”

The amendment would solidify California’s role as a reproductive rights sanctuary as much of the country chips away at birth control availability, Ms. Goodwin added.

Experts said two forms of birth control that are vulnerable to restrictions in other states are intrauterine devices, or IUDs, and emergency contraception such as Plan B. These methods are often incorrectly conflated with abortion pills, which end a pregnancy instead of preventing it.

Nine states have laws that restrict emergency contraception – for example, by allowing pharmacies to refuse to dispense it or excluding it from state family planning programs – according to the Guttmacher Institute, a research organization that supports abortion rights. In Alabama and Louisiana this year, abortion opponents introduced legislation that would restrict or ban abortion, and would also apply to emergency contraception.

“We’re seeing an erosion of abortion access that is playing out in statehouses across the country that have and will continue to target contraceptive care as well,” said Audrey Sandusky, senior director of policy and communications for the National Family Planning and Reproductive Health Association.

Susan Arnall, vice president of California’s Right to Life League, said the proposed amendment is symbolic and merely echoes current laws. Ms. Arnall said the campaign is mostly about Democratic politicians trying to score political points.

“It just allows the pro-abort legislators to trumpet and give them talking points about how they’re doing something about the overturn of Roe v. Wade,” she said. “It is political virtue signaling. I don’t think it does much of anything else.”

Ms. Goodwin argues that the measure’s symbolism is significant and overdue. She pointed to the Civil War era, when enslaved people in Southern states could look to free states for spiritual hope and material help. “Symbolically, what that meant is a kind of beacon of hope, that those places did exist, where one’s humanity could be regarded,” Ms. Goodwin said.

But California’s reputation as a haven for contraceptive availability may not be fully warranted, said Dima Qato, PharmD, PhD, an associate professor at the University of Southern California School of Pharmacy. In her 2020 study of contraceptive access in Los Angeles County, which has some of the highest rates of teen and unintended pregnancy in the country, Dr. Qato found that only 10% of pharmacies surveyed offered pharmacist-prescribed birth control. Pharmacies in low-income and minority communities were the least likely to offer the service, Dr. Qato said, worsening disparities instead of solving them.

Dr. Qato supports the constitutional amendment but said California should focus on improving and enforcing the laws it already has.

“We don’t need more laws when we don’t address the root cause of a lack of effectiveness of these laws in these communities,” she said. “Lack of enforcement and accountability disproportionately impacts communities of color.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Rachel Bluth is a correspondent for California Healthline. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

SACRAMENTO, CALIF. – Californians will decide in November whether to lock the right to abortion into the state constitution.

If they vote “yes” on Proposition 1, they will also lock in a right that has gotten less attention: The right to birth control.

Should the measure succeed, California would become one of the first states – if not the first – to create explicit constitutional rights to both abortion and contraception.

The lawmakers and activists behind the constitutional amendment said they hope to score a one-two punch: Protect abortion in California after the U.S. Supreme Court ended the federal constitutional right to abortion under Roe v. Wade, and get ahead of what they see as the next front in the reproductive rights fight: Birth control.

“The United States Supreme Court said that the privacy and liberty protections in the United States Constitution did not extend to abortion,” said UCLA law professor Cary Franklin, an expert in constitutional law and reproductive rights who has testified before the California legislature in support of the amendment. “If they said ‘no’ on abortion, they’re probably going to say ‘no’ on birth control because that has a similar history.”

In June, the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization ended the federal right to abortion and left states to regulate the service. In his concurring opinion, Justice Clarence Thomas said the court should revisit other cases that have created protections for Americans based on an implicit right to privacy in the U.S. Constitution, such as the 1965 case Griswold v. Connecticut, which established a federal right to contraception for married people, and which was later extended to unmarried people.

Some congressional Democrats are now trying to codify the right to contraception in federal law. In July, the U.S. House of Representatives passed the Right to Contraception Act, which would give patients the right to access and use contraception and providers the right to furnish it. But the bill has little chance of success in the U.S. Senate, where Republicans have already blocked it once.

Protecting access to contraception is popular with voters. A national poll from Morning Consult and Politico conducted in late July found that 75% of registered voters support a federal law that protects a right to birth control access.

California isn’t the only state where voters are considering reproductive rights in their constitutions.

On Aug. 2, Kansas voters decisively rejected a constitutional amendment that would have allowed state lawmakers to ban or dramatically restrict abortion. It failed by nearly 18 percentage points.

Kentucky voters will face a similar decision in November with a proposed constitutional amendment that would declare that the state’s constitutional right to privacy does not cover abortion.

Vermont is going in the opposite direction. Voters there will weigh a ballot measure in November that would add a right to “personal reproductive autonomy” to the state constitution, though it does not explicitly mention abortion or contraception. In Michigan, a proposed constitutional amendment that would guarantee a right to both abortion and contraception is expected to qualify for the November ballot.

In California, Proposition 1 would prevent the state from denying or interfering with “an individual’s reproductive freedom in their most intimate decisions, which includes their fundamental right to choose to have an abortion and their fundamental right to choose or refuse contraceptives.”

The proposed constitutional amendment doesn’t go into detail about what enshrining the right to contraception in the state constitution would mean.

California already has some of the strongest contraceptive-access laws in the country – and lawmakers are considering more proposals this year. For instance, state-regulated health plans must cover all Food and Drug Administration–approved contraception; pharmacists must dispense emergency contraception to anyone with a prescription, regardless of age; and pharmacists can prescribe birth control pills on the spot. State courts have also interpreted California’s constitution to include a right to privacy that covers reproductive health decisions.

The amendment, if adopted, could provide a new legal pathway for people to sue when they’re denied contraceptives, said Michele Goodwin, chancellor’s professor of law at the University of California, Irvine.

If a pharmacist refused to fill a birth control prescription or a cashier declined to ring up condoms, she said, customers could make a case that their rights had been violated.

Making the rights to abortion and contraception explicit in the state constitution – instead of relying on a right to privacy – would also protect against shifting political winds, said state Senate leader Toni Atkins (D–San Diego), who was the director of a women’s health clinic in the 1980s. Although California’s lawmakers and executive officers are solid supporters of abortion rights, she said, the composition of the legislature and courts’ interpretation of laws could change.

“I want to know for sure that that right is protected,” Ms. Atkins said at a legislative hearing in June. “We are protecting ourselves from future courts and future politicians.”

The amendment would solidify California’s role as a reproductive rights sanctuary as much of the country chips away at birth control availability, Ms. Goodwin added.

Experts said two forms of birth control that are vulnerable to restrictions in other states are intrauterine devices, or IUDs, and emergency contraception such as Plan B. These methods are often incorrectly conflated with abortion pills, which end a pregnancy instead of preventing it.

Nine states have laws that restrict emergency contraception – for example, by allowing pharmacies to refuse to dispense it or excluding it from state family planning programs – according to the Guttmacher Institute, a research organization that supports abortion rights. In Alabama and Louisiana this year, abortion opponents introduced legislation that would restrict or ban abortion, and would also apply to emergency contraception.

“We’re seeing an erosion of abortion access that is playing out in statehouses across the country that have and will continue to target contraceptive care as well,” said Audrey Sandusky, senior director of policy and communications for the National Family Planning and Reproductive Health Association.

Susan Arnall, vice president of California’s Right to Life League, said the proposed amendment is symbolic and merely echoes current laws. Ms. Arnall said the campaign is mostly about Democratic politicians trying to score political points.

“It just allows the pro-abort legislators to trumpet and give them talking points about how they’re doing something about the overturn of Roe v. Wade,” she said. “It is political virtue signaling. I don’t think it does much of anything else.”

Ms. Goodwin argues that the measure’s symbolism is significant and overdue. She pointed to the Civil War era, when enslaved people in Southern states could look to free states for spiritual hope and material help. “Symbolically, what that meant is a kind of beacon of hope, that those places did exist, where one’s humanity could be regarded,” Ms. Goodwin said.

But California’s reputation as a haven for contraceptive availability may not be fully warranted, said Dima Qato, PharmD, PhD, an associate professor at the University of Southern California School of Pharmacy. In her 2020 study of contraceptive access in Los Angeles County, which has some of the highest rates of teen and unintended pregnancy in the country, Dr. Qato found that only 10% of pharmacies surveyed offered pharmacist-prescribed birth control. Pharmacies in low-income and minority communities were the least likely to offer the service, Dr. Qato said, worsening disparities instead of solving them.

Dr. Qato supports the constitutional amendment but said California should focus on improving and enforcing the laws it already has.

“We don’t need more laws when we don’t address the root cause of a lack of effectiveness of these laws in these communities,” she said. “Lack of enforcement and accountability disproportionately impacts communities of color.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Rachel Bluth is a correspondent for California Healthline. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

If you grew up in the 1970s and 1980s, chances are high you’re familiar with “Go Ask Alice.”

What was then said to be the real diary of a 15-year-old promising teen turned drug addict was released in 1971 as a cautionary tale and has since sold over 5 million copies. The diary was harrowing against the backdrop of the war on drugs and soon became both acclaimed and banned from classrooms across the country.

Schools citied “inappropriate” language that “borders on pornography” as grounds to prohibit teenagers from reading Alice’s story. But as much as the book’s vivid writing offended readers, it drew millions in with its profanity and graphic descriptions of sex, drugs, and mental health struggles.

At the time, The New York Times reviewed the book as “a strong, painfully honest, nakedly candid and true story ... a document of horrifying reality,” but the popular diary was later found to be a ploy – a fake story written by a 54-year-old Mormon youth counselor named Beatrice Sparks.

Now, Ms. Sparks, who died in 2012, has been further exposed in radio personality Rick Emerson’s new book, “Unmask Alice: LSD, Satanic Panic, and the Imposter Behind the World’s Most Notorious Diaries.” Mr. Emerson published the exposé in July, years after he had the idea to investigate Ms. Sparks’s work in 2015. The book details Ms. Sparks’s background, her journey in creating Alice, and her quest to be recognized for the teen diary she had published as “Anonymous.”

“After 30 years of trying, Beatrice Sparks had changed the world. And nobody knew it,” Mr. Emerson told the New York Post.In his work, Mr. Emerson also dives into the profound impact of the diary at a time when not as much research existed on teen mental health.

When the teenager whose diary inspired Ms. Sparks’s writing “died in March 1971, the very first true study of adolescent psychology had just barely come out,” Mr. Emerson said to Rolling Stone. “Mental health, especially for young people, was still very much on training wheels.”

According to Mr. Emerson, a lack of insight into mental health issues allowed Ms. Sparks’s description to go relatively unchallenged and for the book’s influence to spread despite its misinformation.

“It’s indisputable that large sections of ‘Go Ask Alice’ are just embellished and/or false,” he told the Post.
 

Then versus now

When “Go Ask Alice” was published, child psychiatry and psychology literature contained relatively few references to depression, confirming a 2021 analysis of academic literature on childhood and adolescent depression from 1970 to 2019.

This landscape is in stark contrast to today, where thousands of studies on the topic have been done, compared with the mere dozens in the 1970s.

Anxiety and depression in minors have increased over time, a trend worsened by the COVID-19 pandemic, according to the CDC. Studies have shown that reported drug use in teens has decreased over time, proving significant during the pandemic, according to the National Institutes of Health.

While Alice from “Go Ask Alice” has not existed in either, comparing the two periods can offer insight into teen struggles in the 1970s versus today and sheds light on how literature – fiction or even faked nonfiction – can transform a nation.

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

If you grew up in the 1970s and 1980s, chances are high you’re familiar with “Go Ask Alice.”

What was then said to be the real diary of a 15-year-old promising teen turned drug addict was released in 1971 as a cautionary tale and has since sold over 5 million copies. The diary was harrowing against the backdrop of the war on drugs and soon became both acclaimed and banned from classrooms across the country.

Schools citied “inappropriate” language that “borders on pornography” as grounds to prohibit teenagers from reading Alice’s story. But as much as the book’s vivid writing offended readers, it drew millions in with its profanity and graphic descriptions of sex, drugs, and mental health struggles.

At the time, The New York Times reviewed the book as “a strong, painfully honest, nakedly candid and true story ... a document of horrifying reality,” but the popular diary was later found to be a ploy – a fake story written by a 54-year-old Mormon youth counselor named Beatrice Sparks.

Now, Ms. Sparks, who died in 2012, has been further exposed in radio personality Rick Emerson’s new book, “Unmask Alice: LSD, Satanic Panic, and the Imposter Behind the World’s Most Notorious Diaries.” Mr. Emerson published the exposé in July, years after he had the idea to investigate Ms. Sparks’s work in 2015. The book details Ms. Sparks’s background, her journey in creating Alice, and her quest to be recognized for the teen diary she had published as “Anonymous.”

“After 30 years of trying, Beatrice Sparks had changed the world. And nobody knew it,” Mr. Emerson told the New York Post.In his work, Mr. Emerson also dives into the profound impact of the diary at a time when not as much research existed on teen mental health.

When the teenager whose diary inspired Ms. Sparks’s writing “died in March 1971, the very first true study of adolescent psychology had just barely come out,” Mr. Emerson said to Rolling Stone. “Mental health, especially for young people, was still very much on training wheels.”

According to Mr. Emerson, a lack of insight into mental health issues allowed Ms. Sparks’s description to go relatively unchallenged and for the book’s influence to spread despite its misinformation.

“It’s indisputable that large sections of ‘Go Ask Alice’ are just embellished and/or false,” he told the Post.
 

Then versus now

When “Go Ask Alice” was published, child psychiatry and psychology literature contained relatively few references to depression, confirming a 2021 analysis of academic literature on childhood and adolescent depression from 1970 to 2019.

This landscape is in stark contrast to today, where thousands of studies on the topic have been done, compared with the mere dozens in the 1970s.

Anxiety and depression in minors have increased over time, a trend worsened by the COVID-19 pandemic, according to the CDC. Studies have shown that reported drug use in teens has decreased over time, proving significant during the pandemic, according to the National Institutes of Health.

While Alice from “Go Ask Alice” has not existed in either, comparing the two periods can offer insight into teen struggles in the 1970s versus today and sheds light on how literature – fiction or even faked nonfiction – can transform a nation.

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

If you grew up in the 1970s and 1980s, chances are high you’re familiar with “Go Ask Alice.”

What was then said to be the real diary of a 15-year-old promising teen turned drug addict was released in 1971 as a cautionary tale and has since sold over 5 million copies. The diary was harrowing against the backdrop of the war on drugs and soon became both acclaimed and banned from classrooms across the country.

Schools citied “inappropriate” language that “borders on pornography” as grounds to prohibit teenagers from reading Alice’s story. But as much as the book’s vivid writing offended readers, it drew millions in with its profanity and graphic descriptions of sex, drugs, and mental health struggles.

At the time, The New York Times reviewed the book as “a strong, painfully honest, nakedly candid and true story ... a document of horrifying reality,” but the popular diary was later found to be a ploy – a fake story written by a 54-year-old Mormon youth counselor named Beatrice Sparks.

Now, Ms. Sparks, who died in 2012, has been further exposed in radio personality Rick Emerson’s new book, “Unmask Alice: LSD, Satanic Panic, and the Imposter Behind the World’s Most Notorious Diaries.” Mr. Emerson published the exposé in July, years after he had the idea to investigate Ms. Sparks’s work in 2015. The book details Ms. Sparks’s background, her journey in creating Alice, and her quest to be recognized for the teen diary she had published as “Anonymous.”

“After 30 years of trying, Beatrice Sparks had changed the world. And nobody knew it,” Mr. Emerson told the New York Post.In his work, Mr. Emerson also dives into the profound impact of the diary at a time when not as much research existed on teen mental health.

When the teenager whose diary inspired Ms. Sparks’s writing “died in March 1971, the very first true study of adolescent psychology had just barely come out,” Mr. Emerson said to Rolling Stone. “Mental health, especially for young people, was still very much on training wheels.”

According to Mr. Emerson, a lack of insight into mental health issues allowed Ms. Sparks’s description to go relatively unchallenged and for the book’s influence to spread despite its misinformation.

“It’s indisputable that large sections of ‘Go Ask Alice’ are just embellished and/or false,” he told the Post.
 

Then versus now

When “Go Ask Alice” was published, child psychiatry and psychology literature contained relatively few references to depression, confirming a 2021 analysis of academic literature on childhood and adolescent depression from 1970 to 2019.

This landscape is in stark contrast to today, where thousands of studies on the topic have been done, compared with the mere dozens in the 1970s.

Anxiety and depression in minors have increased over time, a trend worsened by the COVID-19 pandemic, according to the CDC. Studies have shown that reported drug use in teens has decreased over time, proving significant during the pandemic, according to the National Institutes of Health.

While Alice from “Go Ask Alice” has not existed in either, comparing the two periods can offer insight into teen struggles in the 1970s versus today and sheds light on how literature – fiction or even faked nonfiction – can transform a nation.

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

The Food and Drug Administration has approved roflumilast 0.3% cream for the topical treatment of plaque psoriasis, “including intertriginous areas,” in patients aged 12 years and older.

Roflumilast is a selective inhibitor of phosphodiesterase 4 (PDE4), the first approved for treating psoriasis, according to manufacturer Arcutis Biotherapeutics. The company announced the approval on July 29. Oral roflumilast (Daliresp ) was approved in 2011 for treating chronic obstructive pulmonary disease (COPD).“It’s a breakthrough topical therapy,” says Mark G. Lebwohl, MD, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York, and principal investigator in trials of topical roflumilast. In an interview, Dr. Lebwohl noted that the treatment significantly reduced psoriasis symptoms in both short- and long-term trials.

In addition, two features of this treatment set it apart from other topical psoriasis treatments, he said. Roflumilast is not a steroid, so does not have the risk for topical steroid-related side effects associated with chronic use, and, in clinical trials, topical roflumilast was effective in treating psoriasis in intertriginous areas, including the buttocks, underarms, and beneath the breasts, which are difficult to treat.

FDA approval is based on data from two phase 3 randomized, double-blind, vehicle-controlled trials, according to Arcutis. The primary endpoint was Investigator Global Assessment (IGA) success, defined as clear or almost clear with at least a two-grade improvement from baseline, and at least a two-grade IGA score improvement from baseline at 8 weeks.

At 8 weeks, 42.4% and 37.5% of the patients treated with topical roflumilast achieved an IGA success rate compared with 6.1% and 6.9% in the control groups, respectively (P < .0001 for both studies).

Treated patients also experienced significant improvements compared with those in the vehicle groups in secondary endpoints in the trials: Those included Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index–75 (PASI-75), reductions in itch based on the Worst Itch–Numerical Rating Scale (WI-NRS), and self-reported psoriasis symptoms diary (PSD).

In the studies, 72% and 68% of patients treated with roflumilast met the I-IGA endpoint at 8 weeks versus 14% and 17%, respectively, of those on vehicle (P < .0001 for both studies).  

In addition, by week 2, some participants treated with roflumilast had experienced reduced itchiness in both studies. At 8 weeks, among those with a WI-NRS score of 4 or more at baseline, 67% and 69% of the treated patients had at least a four-point reduction in the WI-NRS versus 26% and 33%, respectively, among those on vehicle (P < .0001 for both studies), according to the company.

In general, the cream was well tolerated. There were reports of diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application-site pain (1%), upper respiratory tract infections (1%), and urinary tract infections (1%). However, Dr. Lebwohl noted that these events were also observed in the control group.

“The study was unequivocal about the improvement in the intertriginous sites,” Dr. Lebwohl said. He contrasts that to the data from other nonsteroidal topicals, which he said can be associated with a rash or irritation in sensitive areas.

Dr. Lebwohl noted that PDE4 is an enzyme that increases inflammation and decreases anti-inflammatory mediators and that inhibiting PDE4 may interrupt some of the inflammation response responsible for psoriasis symptoms, as it has for other conditions such as atopic dermatitis. Data from the 8-week phase 3 trials and yearlong phase 2b, open-label studies support that hypothesis.

“I’m always excited for new psoriasis treatments to broaden our treatment armamentarium,” said Lauren E. Ploch, MD, a dermatologist who practices in Augusta, Ga., and Aiken, S.C., who was asked to comment on the approval.

Even a symptom that seems benign, like itching, Dr. Ploch added, can lead to reduced sleep and increased irritability. Referring to the data on the treatment in the sensitive, intertriginous areas, she noted that the skin in these areas is often thinner, so treatment with steroids can cause further thinning and damage to the skin. If roflumilast doesn’t cause burning, itching, or thinning, it will be a great option to treat these areas, she said in an interview. She was not involved in the trials.

Roflumilast cream will be marketed under the trade name Zoryve, and is expected to be available by mid-August, according to Arcutis.

Roflumilast cream is also under review in Canada for treatment of plaque psoriasis in adults and adolescents.

The studies were funded by Arcutis Biotherapeutics. Dr. Lebwohl reported receiving grant support and consulting fees from Arcutis. Dr. Ploch reports no relevant financial relationships.

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

The Food and Drug Administration has approved roflumilast 0.3% cream for the topical treatment of plaque psoriasis, “including intertriginous areas,” in patients aged 12 years and older.

Roflumilast is a selective inhibitor of phosphodiesterase 4 (PDE4), the first approved for treating psoriasis, according to manufacturer Arcutis Biotherapeutics. The company announced the approval on July 29. Oral roflumilast (Daliresp ) was approved in 2011 for treating chronic obstructive pulmonary disease (COPD).“It’s a breakthrough topical therapy,” says Mark G. Lebwohl, MD, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York, and principal investigator in trials of topical roflumilast. In an interview, Dr. Lebwohl noted that the treatment significantly reduced psoriasis symptoms in both short- and long-term trials.

In addition, two features of this treatment set it apart from other topical psoriasis treatments, he said. Roflumilast is not a steroid, so does not have the risk for topical steroid-related side effects associated with chronic use, and, in clinical trials, topical roflumilast was effective in treating psoriasis in intertriginous areas, including the buttocks, underarms, and beneath the breasts, which are difficult to treat.

FDA approval is based on data from two phase 3 randomized, double-blind, vehicle-controlled trials, according to Arcutis. The primary endpoint was Investigator Global Assessment (IGA) success, defined as clear or almost clear with at least a two-grade improvement from baseline, and at least a two-grade IGA score improvement from baseline at 8 weeks.

At 8 weeks, 42.4% and 37.5% of the patients treated with topical roflumilast achieved an IGA success rate compared with 6.1% and 6.9% in the control groups, respectively (P < .0001 for both studies).

Treated patients also experienced significant improvements compared with those in the vehicle groups in secondary endpoints in the trials: Those included Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index–75 (PASI-75), reductions in itch based on the Worst Itch–Numerical Rating Scale (WI-NRS), and self-reported psoriasis symptoms diary (PSD).

In the studies, 72% and 68% of patients treated with roflumilast met the I-IGA endpoint at 8 weeks versus 14% and 17%, respectively, of those on vehicle (P < .0001 for both studies).  

In addition, by week 2, some participants treated with roflumilast had experienced reduced itchiness in both studies. At 8 weeks, among those with a WI-NRS score of 4 or more at baseline, 67% and 69% of the treated patients had at least a four-point reduction in the WI-NRS versus 26% and 33%, respectively, among those on vehicle (P < .0001 for both studies), according to the company.

In general, the cream was well tolerated. There were reports of diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application-site pain (1%), upper respiratory tract infections (1%), and urinary tract infections (1%). However, Dr. Lebwohl noted that these events were also observed in the control group.

“The study was unequivocal about the improvement in the intertriginous sites,” Dr. Lebwohl said. He contrasts that to the data from other nonsteroidal topicals, which he said can be associated with a rash or irritation in sensitive areas.

Dr. Lebwohl noted that PDE4 is an enzyme that increases inflammation and decreases anti-inflammatory mediators and that inhibiting PDE4 may interrupt some of the inflammation response responsible for psoriasis symptoms, as it has for other conditions such as atopic dermatitis. Data from the 8-week phase 3 trials and yearlong phase 2b, open-label studies support that hypothesis.

“I’m always excited for new psoriasis treatments to broaden our treatment armamentarium,” said Lauren E. Ploch, MD, a dermatologist who practices in Augusta, Ga., and Aiken, S.C., who was asked to comment on the approval.

Even a symptom that seems benign, like itching, Dr. Ploch added, can lead to reduced sleep and increased irritability. Referring to the data on the treatment in the sensitive, intertriginous areas, she noted that the skin in these areas is often thinner, so treatment with steroids can cause further thinning and damage to the skin. If roflumilast doesn’t cause burning, itching, or thinning, it will be a great option to treat these areas, she said in an interview. She was not involved in the trials.

Roflumilast cream will be marketed under the trade name Zoryve, and is expected to be available by mid-August, according to Arcutis.

Roflumilast cream is also under review in Canada for treatment of plaque psoriasis in adults and adolescents.

The studies were funded by Arcutis Biotherapeutics. Dr. Lebwohl reported receiving grant support and consulting fees from Arcutis. Dr. Ploch reports no relevant financial relationships.

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

The Food and Drug Administration has approved roflumilast 0.3% cream for the topical treatment of plaque psoriasis, “including intertriginous areas,” in patients aged 12 years and older.

Roflumilast is a selective inhibitor of phosphodiesterase 4 (PDE4), the first approved for treating psoriasis, according to manufacturer Arcutis Biotherapeutics. The company announced the approval on July 29. Oral roflumilast (Daliresp ) was approved in 2011 for treating chronic obstructive pulmonary disease (COPD).“It’s a breakthrough topical therapy,” says Mark G. Lebwohl, MD, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York, and principal investigator in trials of topical roflumilast. In an interview, Dr. Lebwohl noted that the treatment significantly reduced psoriasis symptoms in both short- and long-term trials.

In addition, two features of this treatment set it apart from other topical psoriasis treatments, he said. Roflumilast is not a steroid, so does not have the risk for topical steroid-related side effects associated with chronic use, and, in clinical trials, topical roflumilast was effective in treating psoriasis in intertriginous areas, including the buttocks, underarms, and beneath the breasts, which are difficult to treat.

FDA approval is based on data from two phase 3 randomized, double-blind, vehicle-controlled trials, according to Arcutis. The primary endpoint was Investigator Global Assessment (IGA) success, defined as clear or almost clear with at least a two-grade improvement from baseline, and at least a two-grade IGA score improvement from baseline at 8 weeks.

At 8 weeks, 42.4% and 37.5% of the patients treated with topical roflumilast achieved an IGA success rate compared with 6.1% and 6.9% in the control groups, respectively (P < .0001 for both studies).

Treated patients also experienced significant improvements compared with those in the vehicle groups in secondary endpoints in the trials: Those included Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index–75 (PASI-75), reductions in itch based on the Worst Itch–Numerical Rating Scale (WI-NRS), and self-reported psoriasis symptoms diary (PSD).

In the studies, 72% and 68% of patients treated with roflumilast met the I-IGA endpoint at 8 weeks versus 14% and 17%, respectively, of those on vehicle (P < .0001 for both studies).  

In addition, by week 2, some participants treated with roflumilast had experienced reduced itchiness in both studies. At 8 weeks, among those with a WI-NRS score of 4 or more at baseline, 67% and 69% of the treated patients had at least a four-point reduction in the WI-NRS versus 26% and 33%, respectively, among those on vehicle (P < .0001 for both studies), according to the company.

In general, the cream was well tolerated. There were reports of diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application-site pain (1%), upper respiratory tract infections (1%), and urinary tract infections (1%). However, Dr. Lebwohl noted that these events were also observed in the control group.

“The study was unequivocal about the improvement in the intertriginous sites,” Dr. Lebwohl said. He contrasts that to the data from other nonsteroidal topicals, which he said can be associated with a rash or irritation in sensitive areas.

Dr. Lebwohl noted that PDE4 is an enzyme that increases inflammation and decreases anti-inflammatory mediators and that inhibiting PDE4 may interrupt some of the inflammation response responsible for psoriasis symptoms, as it has for other conditions such as atopic dermatitis. Data from the 8-week phase 3 trials and yearlong phase 2b, open-label studies support that hypothesis.

“I’m always excited for new psoriasis treatments to broaden our treatment armamentarium,” said Lauren E. Ploch, MD, a dermatologist who practices in Augusta, Ga., and Aiken, S.C., who was asked to comment on the approval.

Even a symptom that seems benign, like itching, Dr. Ploch added, can lead to reduced sleep and increased irritability. Referring to the data on the treatment in the sensitive, intertriginous areas, she noted that the skin in these areas is often thinner, so treatment with steroids can cause further thinning and damage to the skin. If roflumilast doesn’t cause burning, itching, or thinning, it will be a great option to treat these areas, she said in an interview. She was not involved in the trials.

Roflumilast cream will be marketed under the trade name Zoryve, and is expected to be available by mid-August, according to Arcutis.

Roflumilast cream is also under review in Canada for treatment of plaque psoriasis in adults and adolescents.

The studies were funded by Arcutis Biotherapeutics. Dr. Lebwohl reported receiving grant support and consulting fees from Arcutis. Dr. Ploch reports no relevant financial relationships.

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

Transgender children, even those as young as 9 or 10 years old, already show increased susceptibility to mental health problems compared with their cisgender peers, new research suggests.

Investigators assessed a sample of more than 7000 children aged 9-10 years in the general population and found those who reported being transgender scored considerably higher on all six subscales of the DSM-5-oriented Child Behavior Checklist (CBCL).

Transgender children had almost sixfold higher odds of suicidality and over twice the odds of depressive and anxiety problems, compared with cisgender children. Moreover, transgender children displayed higher levels of mental health problems compared with previous studies of transgender children recruited from specialist gender clinics.

“Our findings emphasize the vulnerability of transgender children, including those who may not yet have accessed specialist support,” senior author Kenneth C. Pang, MBBS, BMedSc, PhD, associate professor, Murdoch Children’s Research Institute, University of Melbourne, Royal Children’s Hospital, Australia, told this news organization.

“Clinicians providing general health care to transgender children should keep this vulnerability in mind and proactively address any mental health problems that exist,” he said.

The findings were published online as a research letter in JAMA Network Open.
 

Higher levels of support?

“We felt this study was important to conduct because previous studies regarding the mental health of transgender children have been drawn from children receiving specialist gender-related care,” Dr. Pang said.

“Transgender children receiving such care are likely to enjoy higher levels of support than those unable to access such services, and this might create differences in mental health,” he added.

To investigate this issue, the researchers turned to participants (n = 7,169; mean age, 10.3 years) in the Adolescent Brain Cognitive Development (ABCD) study.

“The ABCD study is a longitudinal study of over 11,000 children who were recruited to reflect the sociodemographic variation of the U.S. population,” lead author Douglas H. Russell, MSc, a PhD candidate at the University of Melbourne, told this news organization.

To be included in the current study, children had to understand and respond to the question “Are you transgender?”

The researchers compared mental health outcomes between transgender and cisgender children (n = 58 and n = 7,111, respectively) using the CBCL, which study participants had completed at baseline.
 

Key protective factor

The transgender children recorded higher mean T scores for all six subscales of the CBCL, although all children scored in the references range; and the standardized mean difference was “small.”

Suicidality was measured by summing the two suicide-related items in the parent-report CBCL assessing suicidal ideation and attempts.

“For the CBCL, T scores are calculated for measures that are scored on a continuous scale,” Dr. Pang noted. “Responses to the suicidality questions on the CBCL were assessed in a categorical manner (at risk of suicide vs. not), as previously described by others. So T scores were therefore not able to be calculated.”

When the investigators determined the proportion of cisgender and transgender children who scored in the “borderline” or “clinical” range (T score, 65), they found increased odds of transgender children scoring in that range in all six subscales, as well as suicidality.

The researchers note the results for attention-deficit/hyperactivity disorder and oppositional defiant problems were not statistically significant.

Previous studies that used clinical samples of young transgender children (aged 5 -11 years) reported lower rates of depression and anxiety than what was found in the current study.

“Transgender children in the general population displayed higher levels of mental health problems compared to previous studies of transgender children recruited from specialist gender clinics,” Mr. Russell said.

One reason for that may be children in specialist clinics “are likely to have support from their families (a key protective factor for the mental health of transgender young people); in comparison, many transgender children in the general population lack parental support for their gender,” the investigators wrote.

“Our findings suggest that by 9 to 10 years of age transgender children already show increased susceptibility to mental health problems compared with their cisgender peers, which has important public health implications,” they added.

The researchers noted that whether this susceptibility “is due to stigma, minority stress, discrimination, or gender dysphoria is unclear, but providing appropriate mental health supports to this vulnerable group is paramount.”
 

“Pathologizing and damaging”

Commenting for this news organiztion, Jack L. Turban, MD, incoming assistant professor of child and adolescent psychiatry, University of California, San Francisco, said that “sadly” the findings are “largely in line with past studies that have shown dramatic mental health disparities” for transgender and gender diverse youth.

“The dramatically elevated odds of suicidality warrants particular public health concern,” said Dr. Turban, who was not involved with the study.

He noted these results “come at a time when transgender youth are under legislative attack in many states throughout the country, and the national rhetoric around them has been pathologizing and damaging.”

Dr. Turban said that he worries “if our national discourse around trans youth doesn’t change soon, that these disparities will worsen.”

Funding was provided to individual investigators by the Hugh Williamson Foundation, the Royal Children’s Hospital foundation, the National Health and Medical Research Council, and the Australian Government Research Training Program Scholarship. Mr. Russell and Dr. Pang reported being members of the Australian Professional Association for Trans Health. Dr. Pang is a member of the World Professional Association for Transgender Health and a member of the editorial board of the journal Transgender Health. Dr. Turban reported textbook royalties from Springer Nature, being on the scientific advisory board of Panorama Global (UpSwing Fund), and payments as an expert witness for the American Civil Liberties Union, Lambda Legal, and Cooley LLP. He has received a pilot research award from AACAP and pharmaceutical partners (Arbor and Pfizer), a research fellowship from the Sorensen Foundation, and freelance payments from the New York Times, the Washington Post, and the Los Angeles Times.

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

Transgender children, even those as young as 9 or 10 years old, already show increased susceptibility to mental health problems compared with their cisgender peers, new research suggests.

Investigators assessed a sample of more than 7000 children aged 9-10 years in the general population and found those who reported being transgender scored considerably higher on all six subscales of the DSM-5-oriented Child Behavior Checklist (CBCL).

Transgender children had almost sixfold higher odds of suicidality and over twice the odds of depressive and anxiety problems, compared with cisgender children. Moreover, transgender children displayed higher levels of mental health problems compared with previous studies of transgender children recruited from specialist gender clinics.

“Our findings emphasize the vulnerability of transgender children, including those who may not yet have accessed specialist support,” senior author Kenneth C. Pang, MBBS, BMedSc, PhD, associate professor, Murdoch Children’s Research Institute, University of Melbourne, Royal Children’s Hospital, Australia, told this news organization.

“Clinicians providing general health care to transgender children should keep this vulnerability in mind and proactively address any mental health problems that exist,” he said.

The findings were published online as a research letter in JAMA Network Open.
 

Higher levels of support?

“We felt this study was important to conduct because previous studies regarding the mental health of transgender children have been drawn from children receiving specialist gender-related care,” Dr. Pang said.

“Transgender children receiving such care are likely to enjoy higher levels of support than those unable to access such services, and this might create differences in mental health,” he added.

To investigate this issue, the researchers turned to participants (n = 7,169; mean age, 10.3 years) in the Adolescent Brain Cognitive Development (ABCD) study.

“The ABCD study is a longitudinal study of over 11,000 children who were recruited to reflect the sociodemographic variation of the U.S. population,” lead author Douglas H. Russell, MSc, a PhD candidate at the University of Melbourne, told this news organization.

To be included in the current study, children had to understand and respond to the question “Are you transgender?”

The researchers compared mental health outcomes between transgender and cisgender children (n = 58 and n = 7,111, respectively) using the CBCL, which study participants had completed at baseline.
 

Key protective factor

The transgender children recorded higher mean T scores for all six subscales of the CBCL, although all children scored in the references range; and the standardized mean difference was “small.”

Suicidality was measured by summing the two suicide-related items in the parent-report CBCL assessing suicidal ideation and attempts.

“For the CBCL, T scores are calculated for measures that are scored on a continuous scale,” Dr. Pang noted. “Responses to the suicidality questions on the CBCL were assessed in a categorical manner (at risk of suicide vs. not), as previously described by others. So T scores were therefore not able to be calculated.”

When the investigators determined the proportion of cisgender and transgender children who scored in the “borderline” or “clinical” range (T score, 65), they found increased odds of transgender children scoring in that range in all six subscales, as well as suicidality.

The researchers note the results for attention-deficit/hyperactivity disorder and oppositional defiant problems were not statistically significant.

Previous studies that used clinical samples of young transgender children (aged 5 -11 years) reported lower rates of depression and anxiety than what was found in the current study.

“Transgender children in the general population displayed higher levels of mental health problems compared to previous studies of transgender children recruited from specialist gender clinics,” Mr. Russell said.

One reason for that may be children in specialist clinics “are likely to have support from their families (a key protective factor for the mental health of transgender young people); in comparison, many transgender children in the general population lack parental support for their gender,” the investigators wrote.

“Our findings suggest that by 9 to 10 years of age transgender children already show increased susceptibility to mental health problems compared with their cisgender peers, which has important public health implications,” they added.

The researchers noted that whether this susceptibility “is due to stigma, minority stress, discrimination, or gender dysphoria is unclear, but providing appropriate mental health supports to this vulnerable group is paramount.”
 

“Pathologizing and damaging”

Commenting for this news organiztion, Jack L. Turban, MD, incoming assistant professor of child and adolescent psychiatry, University of California, San Francisco, said that “sadly” the findings are “largely in line with past studies that have shown dramatic mental health disparities” for transgender and gender diverse youth.

“The dramatically elevated odds of suicidality warrants particular public health concern,” said Dr. Turban, who was not involved with the study.

He noted these results “come at a time when transgender youth are under legislative attack in many states throughout the country, and the national rhetoric around them has been pathologizing and damaging.”

Dr. Turban said that he worries “if our national discourse around trans youth doesn’t change soon, that these disparities will worsen.”

Funding was provided to individual investigators by the Hugh Williamson Foundation, the Royal Children’s Hospital foundation, the National Health and Medical Research Council, and the Australian Government Research Training Program Scholarship. Mr. Russell and Dr. Pang reported being members of the Australian Professional Association for Trans Health. Dr. Pang is a member of the World Professional Association for Transgender Health and a member of the editorial board of the journal Transgender Health. Dr. Turban reported textbook royalties from Springer Nature, being on the scientific advisory board of Panorama Global (UpSwing Fund), and payments as an expert witness for the American Civil Liberties Union, Lambda Legal, and Cooley LLP. He has received a pilot research award from AACAP and pharmaceutical partners (Arbor and Pfizer), a research fellowship from the Sorensen Foundation, and freelance payments from the New York Times, the Washington Post, and the Los Angeles Times.

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

Transgender children, even those as young as 9 or 10 years old, already show increased susceptibility to mental health problems compared with their cisgender peers, new research suggests.

Investigators assessed a sample of more than 7000 children aged 9-10 years in the general population and found those who reported being transgender scored considerably higher on all six subscales of the DSM-5-oriented Child Behavior Checklist (CBCL).

Transgender children had almost sixfold higher odds of suicidality and over twice the odds of depressive and anxiety problems, compared with cisgender children. Moreover, transgender children displayed higher levels of mental health problems compared with previous studies of transgender children recruited from specialist gender clinics.

“Our findings emphasize the vulnerability of transgender children, including those who may not yet have accessed specialist support,” senior author Kenneth C. Pang, MBBS, BMedSc, PhD, associate professor, Murdoch Children’s Research Institute, University of Melbourne, Royal Children’s Hospital, Australia, told this news organization.

“Clinicians providing general health care to transgender children should keep this vulnerability in mind and proactively address any mental health problems that exist,” he said.

The findings were published online as a research letter in JAMA Network Open.
 

Higher levels of support?

“We felt this study was important to conduct because previous studies regarding the mental health of transgender children have been drawn from children receiving specialist gender-related care,” Dr. Pang said.

“Transgender children receiving such care are likely to enjoy higher levels of support than those unable to access such services, and this might create differences in mental health,” he added.

To investigate this issue, the researchers turned to participants (n = 7,169; mean age, 10.3 years) in the Adolescent Brain Cognitive Development (ABCD) study.

“The ABCD study is a longitudinal study of over 11,000 children who were recruited to reflect the sociodemographic variation of the U.S. population,” lead author Douglas H. Russell, MSc, a PhD candidate at the University of Melbourne, told this news organization.

To be included in the current study, children had to understand and respond to the question “Are you transgender?”

The researchers compared mental health outcomes between transgender and cisgender children (n = 58 and n = 7,111, respectively) using the CBCL, which study participants had completed at baseline.
 

Key protective factor

The transgender children recorded higher mean T scores for all six subscales of the CBCL, although all children scored in the references range; and the standardized mean difference was “small.”

Suicidality was measured by summing the two suicide-related items in the parent-report CBCL assessing suicidal ideation and attempts.

“For the CBCL, T scores are calculated for measures that are scored on a continuous scale,” Dr. Pang noted. “Responses to the suicidality questions on the CBCL were assessed in a categorical manner (at risk of suicide vs. not), as previously described by others. So T scores were therefore not able to be calculated.”

When the investigators determined the proportion of cisgender and transgender children who scored in the “borderline” or “clinical” range (T score, 65), they found increased odds of transgender children scoring in that range in all six subscales, as well as suicidality.

The researchers note the results for attention-deficit/hyperactivity disorder and oppositional defiant problems were not statistically significant.

Previous studies that used clinical samples of young transgender children (aged 5 -11 years) reported lower rates of depression and anxiety than what was found in the current study.

“Transgender children in the general population displayed higher levels of mental health problems compared to previous studies of transgender children recruited from specialist gender clinics,” Mr. Russell said.

One reason for that may be children in specialist clinics “are likely to have support from their families (a key protective factor for the mental health of transgender young people); in comparison, many transgender children in the general population lack parental support for their gender,” the investigators wrote.

“Our findings suggest that by 9 to 10 years of age transgender children already show increased susceptibility to mental health problems compared with their cisgender peers, which has important public health implications,” they added.

The researchers noted that whether this susceptibility “is due to stigma, minority stress, discrimination, or gender dysphoria is unclear, but providing appropriate mental health supports to this vulnerable group is paramount.”
 

“Pathologizing and damaging”

Commenting for this news organiztion, Jack L. Turban, MD, incoming assistant professor of child and adolescent psychiatry, University of California, San Francisco, said that “sadly” the findings are “largely in line with past studies that have shown dramatic mental health disparities” for transgender and gender diverse youth.

“The dramatically elevated odds of suicidality warrants particular public health concern,” said Dr. Turban, who was not involved with the study.

He noted these results “come at a time when transgender youth are under legislative attack in many states throughout the country, and the national rhetoric around them has been pathologizing and damaging.”

Dr. Turban said that he worries “if our national discourse around trans youth doesn’t change soon, that these disparities will worsen.”

Funding was provided to individual investigators by the Hugh Williamson Foundation, the Royal Children’s Hospital foundation, the National Health and Medical Research Council, and the Australian Government Research Training Program Scholarship. Mr. Russell and Dr. Pang reported being members of the Australian Professional Association for Trans Health. Dr. Pang is a member of the World Professional Association for Transgender Health and a member of the editorial board of the journal Transgender Health. Dr. Turban reported textbook royalties from Springer Nature, being on the scientific advisory board of Panorama Global (UpSwing Fund), and payments as an expert witness for the American Civil Liberties Union, Lambda Legal, and Cooley LLP. He has received a pilot research award from AACAP and pharmaceutical partners (Arbor and Pfizer), a research fellowship from the Sorensen Foundation, and freelance payments from the New York Times, the Washington Post, and the Los Angeles Times.

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

The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) has changed the recommendation for vaccines against human papillomavirus (HPV).

From the available evidence, SAGE has concluded that a single dose of vaccine offers solid protection against HPV, comparable to that achieved with two-dose schedules.

This could be a “game-changer for the prevention of the disease,” as it would allow “more doses of the life-saving jab reach more girls,” the WHO declared in a press release.

SAGE recommends updating HPV dose schedules as follows:

• One- or two-dose schedule for the primary target of girls aged 9-14 years.
• One- or two-dose schedule for young women aged 15-20.
• Two doses with a 6-month interval for women older than 21.

The HPV vaccine is highly effective for the prevention of HPV serotypes 16 and 18, which cause 70% of cases of cervical cancer, said Alejandro Cravioto, MD, PhD, SAGE chair, in a statement.

“SAGE urges all countries to introduce HPV vaccines and prioritize multi-age cohort catch up of missed and older cohorts of girls. These recommendations will enable more girls and women to be vaccinated and thus preventing them from having cervical cancer and all its consequences over the course of their lifetimes,” he added.

For individuals who are immunocompromised, including those with HIV, three doses of the vaccine should be given if feasible, and if not, then at least two doses. There is limited evidence regarding the efficacy of a single dose in this group, the advisory group noted.
 

Policy makers need to make changes

Now that the WHO has deemed that one dose of HPV vaccine is sufficient, policy makers should make changes, say experts in a recent editorial comment published in The Lancet Oncology.

“Policy makers should consider modifying their HPV immunization schedules for girls aged 9-14 years from a two-dose regimen to a one-dose regimen,” wrote Jeff D’Souza, PhD, Institute for Better Health, Trillium Health Partners, Mississauga, Ont., and David Nderitu, PhD, Egerton University, Nakuru County, Kenya.

Policy makers also need to consider reorienting their efforts on cervical cancer screening and treatment, and they should ensure that all girls globally have access to an effective HPV vaccination schedule, they add.

The editorialists also make a radical proposal.

Existing supply constraints of the HPV vaccine at the country level are expected to continue for the next 3 years, and the vast majority of new cervical cancer cases and related deaths occur in low- and middle-income countries (LMICs).

To overcome these problems, they suggest that “high-income countries that currently offer two-dose regimens to girls aged 9-14 years should consider opting for a one-dose vaccination schedule, and give any excess of vaccines to countries in greater need of them.”
 

Two doses in high-income countries

But it is unclear whether high-income countries are ready to move to a one-dose schedule.

Approached for comment, Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, Philadelphia, told this news organization that while he can’t say for certain, he suspects that the United States will be slower to accept this recommendation for a single dose of HPV vaccine “as a component of a ‘standard-of-care’ approach.”

However, it “might formally acknowledge that if an individual/parent will only accept a single vaccine dose (or ultimately refuses to return for a recommended second dose), this will be considered a favorable outcome, both for the individual and society.

“I do not know if regulatory bodies in the United States will accept the existing studies performed to address the one-dose vaccination strategy to rather dramatically change the approach in our country,” he said. “The issue would be that if a single dose was stated to be a clinically acceptable option in the United States, it would rapidly become the standard approach, and the regulators would want to be as certain as possible that this would not have a negative effect on what is now recognized to be a remarkably safe and effective cancer prevention effort.”

Another expert who was approached for comment, Stephanie V. Blank, MD, professor of gynecologic oncology at the Icahn School of Medicine at Mount Sinai, New York, said: “In higher-resourced countries, two doses are still preferred, as they are more effective than one.

“The modeling on which the SAGE recommendation is based is all from studies in LMICs and other modeling studies,” she added.

At present, the Centers for Disease Control and Prevention recommends a two-dose schedule of HPV vaccines for individuals who receive the first dose before their 15th birthday. The three-dose schedule is recommended for those who receive the first dose on or after their 15th birthday and for people with certain immunocompromising conditions.

Studies have shown that two doses of HPV vaccine given to children aged 9-14 years provide as good or better protection than three doses given to older adolescents or young adults.

But even with a two-dose schedule, the WHO reports that uptake of the vaccine has been slow, and coverage is much lower than their 90% target. In 2020, global coverage with two doses was only 13%.

Factors that have influenced the slow uptake and low coverage of HPV vaccines include supply challenges, programmatic challenges, and costs related to delivering a two-dose regimen to older girls who are not typically included in childhood vaccination programs. The relatively high cost of HPV vaccines has also been problematic, particularly for middle-income countries.
 

Trials of one-dose schedules

The one-dose vaccine schedule has garnered a lot of interest, with several studies showing efficacy.

The KEN SHE trial, based in Kenya, showed that a single dose of the HPV vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens. Vaccine efficacy was 97.5% (P < .001) against HPV 16/18 for both the bivalent and monovalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers noted.

A study in India found that efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95.4% for the single dose, 93.1% for the two-dose schedule, and 93.3% for the three-dose series.

Commenting on this trial in India in a recent interview with this news organization, Geoffroy Canlorbe, MD, PhD, of the department of gynecologic and breast surgery and oncology, Pitié-Salpêtrière Hospital, Paris, said the findings from India would need “to be confirmed by other studies.” The results were nonetheless “excellent news for developing countries where there are challenges when it comes to access to vaccination.”

Speaking at the 45th Congress of the French Society for Colposcopy and Cervical and Vaginal Diseases, he emphasized that at this stage, the findings “cannot be extrapolated” to France. HPV vaccination coverage is low in France (it is estimated that the rate is 23.7%, placing the country 28th of 31 countries in Europe), and he recommended continuing with the two- or three-dose schedule for the time being.

“This poor coverage has nothing to do with health care–related logistical or organizational issues; instead, it has to do with people’s mistrust when it comes to vaccination. Here, people who get the first dose get the subsequent ones,” said Dr. Canlorbe. “The very fact of getting two to three doses allows the person’s body to increase the production of antibodies and get a longer-lasting response to the vaccine.”
 

Ethics of the vaccine

In their editorial, Dr. D’Souza and Dr. Nderitu note that there are ethical considerations with the HPV vaccine that can “help guide deliberations, covering nonmaleficence, beneficence, health equity, stewardship, and solidarity.”

It would be inequitable and unjustifiable, they write, to offer a two-dose regimen to girls aged 9-14 years without also introducing multi-age cohort catch-up campaigns or programs for women who do not have access. “When it comes to an effective HPV vaccination schedule, no woman or girl should be left behind,” they say.

To achieve the goal of eliminating cervical cancer, “countries must ensure that 90% of girls are vaccinated, 70% of women are screened, and 90% of women with precancerous lesions receive treatment and care,” they write. “Given resource constraints, particularly in low-middle income countries, policy makers have a responsibility to ensure that resources are used in an optimal manner that promotes the right to health of all individuals.”

Thus, countries that are lagging far behind in cervical cancer education, screening, and treatment should consider opting for a one-dose regimen for girls aged 9-14 years, as well as using additional resources to close the gap in these other areas.

Dr. Markman has relationships with Genentech, AstraZeneca, Celgene, Clovis, and Amgen; he is also a regular contributor to Medscape Oncology with the Markamn on Oncology video column. Dr. D’Souza and Dr. Nderitu have disclosed no relevant financial relationships.

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

The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) has changed the recommendation for vaccines against human papillomavirus (HPV).

From the available evidence, SAGE has concluded that a single dose of vaccine offers solid protection against HPV, comparable to that achieved with two-dose schedules.

This could be a “game-changer for the prevention of the disease,” as it would allow “more doses of the life-saving jab reach more girls,” the WHO declared in a press release.

SAGE recommends updating HPV dose schedules as follows:

• One- or two-dose schedule for the primary target of girls aged 9-14 years.
• One- or two-dose schedule for young women aged 15-20.
• Two doses with a 6-month interval for women older than 21.

The HPV vaccine is highly effective for the prevention of HPV serotypes 16 and 18, which cause 70% of cases of cervical cancer, said Alejandro Cravioto, MD, PhD, SAGE chair, in a statement.

“SAGE urges all countries to introduce HPV vaccines and prioritize multi-age cohort catch up of missed and older cohorts of girls. These recommendations will enable more girls and women to be vaccinated and thus preventing them from having cervical cancer and all its consequences over the course of their lifetimes,” he added.

For individuals who are immunocompromised, including those with HIV, three doses of the vaccine should be given if feasible, and if not, then at least two doses. There is limited evidence regarding the efficacy of a single dose in this group, the advisory group noted.
 

Policy makers need to make changes

Now that the WHO has deemed that one dose of HPV vaccine is sufficient, policy makers should make changes, say experts in a recent editorial comment published in The Lancet Oncology.

“Policy makers should consider modifying their HPV immunization schedules for girls aged 9-14 years from a two-dose regimen to a one-dose regimen,” wrote Jeff D’Souza, PhD, Institute for Better Health, Trillium Health Partners, Mississauga, Ont., and David Nderitu, PhD, Egerton University, Nakuru County, Kenya.

Policy makers also need to consider reorienting their efforts on cervical cancer screening and treatment, and they should ensure that all girls globally have access to an effective HPV vaccination schedule, they add.

The editorialists also make a radical proposal.

Existing supply constraints of the HPV vaccine at the country level are expected to continue for the next 3 years, and the vast majority of new cervical cancer cases and related deaths occur in low- and middle-income countries (LMICs).

To overcome these problems, they suggest that “high-income countries that currently offer two-dose regimens to girls aged 9-14 years should consider opting for a one-dose vaccination schedule, and give any excess of vaccines to countries in greater need of them.”
 

Two doses in high-income countries

But it is unclear whether high-income countries are ready to move to a one-dose schedule.

Approached for comment, Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, Philadelphia, told this news organization that while he can’t say for certain, he suspects that the United States will be slower to accept this recommendation for a single dose of HPV vaccine “as a component of a ‘standard-of-care’ approach.”

However, it “might formally acknowledge that if an individual/parent will only accept a single vaccine dose (or ultimately refuses to return for a recommended second dose), this will be considered a favorable outcome, both for the individual and society.

“I do not know if regulatory bodies in the United States will accept the existing studies performed to address the one-dose vaccination strategy to rather dramatically change the approach in our country,” he said. “The issue would be that if a single dose was stated to be a clinically acceptable option in the United States, it would rapidly become the standard approach, and the regulators would want to be as certain as possible that this would not have a negative effect on what is now recognized to be a remarkably safe and effective cancer prevention effort.”

Another expert who was approached for comment, Stephanie V. Blank, MD, professor of gynecologic oncology at the Icahn School of Medicine at Mount Sinai, New York, said: “In higher-resourced countries, two doses are still preferred, as they are more effective than one.

“The modeling on which the SAGE recommendation is based is all from studies in LMICs and other modeling studies,” she added.

At present, the Centers for Disease Control and Prevention recommends a two-dose schedule of HPV vaccines for individuals who receive the first dose before their 15th birthday. The three-dose schedule is recommended for those who receive the first dose on or after their 15th birthday and for people with certain immunocompromising conditions.

Studies have shown that two doses of HPV vaccine given to children aged 9-14 years provide as good or better protection than three doses given to older adolescents or young adults.

But even with a two-dose schedule, the WHO reports that uptake of the vaccine has been slow, and coverage is much lower than their 90% target. In 2020, global coverage with two doses was only 13%.

Factors that have influenced the slow uptake and low coverage of HPV vaccines include supply challenges, programmatic challenges, and costs related to delivering a two-dose regimen to older girls who are not typically included in childhood vaccination programs. The relatively high cost of HPV vaccines has also been problematic, particularly for middle-income countries.
 

Trials of one-dose schedules

The one-dose vaccine schedule has garnered a lot of interest, with several studies showing efficacy.

The KEN SHE trial, based in Kenya, showed that a single dose of the HPV vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens. Vaccine efficacy was 97.5% (P < .001) against HPV 16/18 for both the bivalent and monovalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers noted.

A study in India found that efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95.4% for the single dose, 93.1% for the two-dose schedule, and 93.3% for the three-dose series.

Commenting on this trial in India in a recent interview with this news organization, Geoffroy Canlorbe, MD, PhD, of the department of gynecologic and breast surgery and oncology, Pitié-Salpêtrière Hospital, Paris, said the findings from India would need “to be confirmed by other studies.” The results were nonetheless “excellent news for developing countries where there are challenges when it comes to access to vaccination.”

Speaking at the 45th Congress of the French Society for Colposcopy and Cervical and Vaginal Diseases, he emphasized that at this stage, the findings “cannot be extrapolated” to France. HPV vaccination coverage is low in France (it is estimated that the rate is 23.7%, placing the country 28th of 31 countries in Europe), and he recommended continuing with the two- or three-dose schedule for the time being.

“This poor coverage has nothing to do with health care–related logistical or organizational issues; instead, it has to do with people’s mistrust when it comes to vaccination. Here, people who get the first dose get the subsequent ones,” said Dr. Canlorbe. “The very fact of getting two to three doses allows the person’s body to increase the production of antibodies and get a longer-lasting response to the vaccine.”
 

Ethics of the vaccine

In their editorial, Dr. D’Souza and Dr. Nderitu note that there are ethical considerations with the HPV vaccine that can “help guide deliberations, covering nonmaleficence, beneficence, health equity, stewardship, and solidarity.”

It would be inequitable and unjustifiable, they write, to offer a two-dose regimen to girls aged 9-14 years without also introducing multi-age cohort catch-up campaigns or programs for women who do not have access. “When it comes to an effective HPV vaccination schedule, no woman or girl should be left behind,” they say.

To achieve the goal of eliminating cervical cancer, “countries must ensure that 90% of girls are vaccinated, 70% of women are screened, and 90% of women with precancerous lesions receive treatment and care,” they write. “Given resource constraints, particularly in low-middle income countries, policy makers have a responsibility to ensure that resources are used in an optimal manner that promotes the right to health of all individuals.”

Thus, countries that are lagging far behind in cervical cancer education, screening, and treatment should consider opting for a one-dose regimen for girls aged 9-14 years, as well as using additional resources to close the gap in these other areas.

Dr. Markman has relationships with Genentech, AstraZeneca, Celgene, Clovis, and Amgen; he is also a regular contributor to Medscape Oncology with the Markamn on Oncology video column. Dr. D’Souza and Dr. Nderitu have disclosed no relevant financial relationships.

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

The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) has changed the recommendation for vaccines against human papillomavirus (HPV).

From the available evidence, SAGE has concluded that a single dose of vaccine offers solid protection against HPV, comparable to that achieved with two-dose schedules.

This could be a “game-changer for the prevention of the disease,” as it would allow “more doses of the life-saving jab reach more girls,” the WHO declared in a press release.

SAGE recommends updating HPV dose schedules as follows:

• One- or two-dose schedule for the primary target of girls aged 9-14 years.
• One- or two-dose schedule for young women aged 15-20.
• Two doses with a 6-month interval for women older than 21.

The HPV vaccine is highly effective for the prevention of HPV serotypes 16 and 18, which cause 70% of cases of cervical cancer, said Alejandro Cravioto, MD, PhD, SAGE chair, in a statement.

“SAGE urges all countries to introduce HPV vaccines and prioritize multi-age cohort catch up of missed and older cohorts of girls. These recommendations will enable more girls and women to be vaccinated and thus preventing them from having cervical cancer and all its consequences over the course of their lifetimes,” he added.

For individuals who are immunocompromised, including those with HIV, three doses of the vaccine should be given if feasible, and if not, then at least two doses. There is limited evidence regarding the efficacy of a single dose in this group, the advisory group noted.
 

Policy makers need to make changes

Now that the WHO has deemed that one dose of HPV vaccine is sufficient, policy makers should make changes, say experts in a recent editorial comment published in The Lancet Oncology.

“Policy makers should consider modifying their HPV immunization schedules for girls aged 9-14 years from a two-dose regimen to a one-dose regimen,” wrote Jeff D’Souza, PhD, Institute for Better Health, Trillium Health Partners, Mississauga, Ont., and David Nderitu, PhD, Egerton University, Nakuru County, Kenya.

Policy makers also need to consider reorienting their efforts on cervical cancer screening and treatment, and they should ensure that all girls globally have access to an effective HPV vaccination schedule, they add.

The editorialists also make a radical proposal.

Existing supply constraints of the HPV vaccine at the country level are expected to continue for the next 3 years, and the vast majority of new cervical cancer cases and related deaths occur in low- and middle-income countries (LMICs).

To overcome these problems, they suggest that “high-income countries that currently offer two-dose regimens to girls aged 9-14 years should consider opting for a one-dose vaccination schedule, and give any excess of vaccines to countries in greater need of them.”
 

Two doses in high-income countries

But it is unclear whether high-income countries are ready to move to a one-dose schedule.

Approached for comment, Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, Philadelphia, told this news organization that while he can’t say for certain, he suspects that the United States will be slower to accept this recommendation for a single dose of HPV vaccine “as a component of a ‘standard-of-care’ approach.”

However, it “might formally acknowledge that if an individual/parent will only accept a single vaccine dose (or ultimately refuses to return for a recommended second dose), this will be considered a favorable outcome, both for the individual and society.

“I do not know if regulatory bodies in the United States will accept the existing studies performed to address the one-dose vaccination strategy to rather dramatically change the approach in our country,” he said. “The issue would be that if a single dose was stated to be a clinically acceptable option in the United States, it would rapidly become the standard approach, and the regulators would want to be as certain as possible that this would not have a negative effect on what is now recognized to be a remarkably safe and effective cancer prevention effort.”

Another expert who was approached for comment, Stephanie V. Blank, MD, professor of gynecologic oncology at the Icahn School of Medicine at Mount Sinai, New York, said: “In higher-resourced countries, two doses are still preferred, as they are more effective than one.

“The modeling on which the SAGE recommendation is based is all from studies in LMICs and other modeling studies,” she added.

At present, the Centers for Disease Control and Prevention recommends a two-dose schedule of HPV vaccines for individuals who receive the first dose before their 15th birthday. The three-dose schedule is recommended for those who receive the first dose on or after their 15th birthday and for people with certain immunocompromising conditions.

Studies have shown that two doses of HPV vaccine given to children aged 9-14 years provide as good or better protection than three doses given to older adolescents or young adults.

But even with a two-dose schedule, the WHO reports that uptake of the vaccine has been slow, and coverage is much lower than their 90% target. In 2020, global coverage with two doses was only 13%.

Factors that have influenced the slow uptake and low coverage of HPV vaccines include supply challenges, programmatic challenges, and costs related to delivering a two-dose regimen to older girls who are not typically included in childhood vaccination programs. The relatively high cost of HPV vaccines has also been problematic, particularly for middle-income countries.
 

Trials of one-dose schedules

The one-dose vaccine schedule has garnered a lot of interest, with several studies showing efficacy.

The KEN SHE trial, based in Kenya, showed that a single dose of the HPV vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens. Vaccine efficacy was 97.5% (P < .001) against HPV 16/18 for both the bivalent and monovalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers noted.

A study in India found that efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95.4% for the single dose, 93.1% for the two-dose schedule, and 93.3% for the three-dose series.

Commenting on this trial in India in a recent interview with this news organization, Geoffroy Canlorbe, MD, PhD, of the department of gynecologic and breast surgery and oncology, Pitié-Salpêtrière Hospital, Paris, said the findings from India would need “to be confirmed by other studies.” The results were nonetheless “excellent news for developing countries where there are challenges when it comes to access to vaccination.”

Speaking at the 45th Congress of the French Society for Colposcopy and Cervical and Vaginal Diseases, he emphasized that at this stage, the findings “cannot be extrapolated” to France. HPV vaccination coverage is low in France (it is estimated that the rate is 23.7%, placing the country 28th of 31 countries in Europe), and he recommended continuing with the two- or three-dose schedule for the time being.

“This poor coverage has nothing to do with health care–related logistical or organizational issues; instead, it has to do with people’s mistrust when it comes to vaccination. Here, people who get the first dose get the subsequent ones,” said Dr. Canlorbe. “The very fact of getting two to three doses allows the person’s body to increase the production of antibodies and get a longer-lasting response to the vaccine.”
 

Ethics of the vaccine

In their editorial, Dr. D’Souza and Dr. Nderitu note that there are ethical considerations with the HPV vaccine that can “help guide deliberations, covering nonmaleficence, beneficence, health equity, stewardship, and solidarity.”

It would be inequitable and unjustifiable, they write, to offer a two-dose regimen to girls aged 9-14 years without also introducing multi-age cohort catch-up campaigns or programs for women who do not have access. “When it comes to an effective HPV vaccination schedule, no woman or girl should be left behind,” they say.

To achieve the goal of eliminating cervical cancer, “countries must ensure that 90% of girls are vaccinated, 70% of women are screened, and 90% of women with precancerous lesions receive treatment and care,” they write. “Given resource constraints, particularly in low-middle income countries, policy makers have a responsibility to ensure that resources are used in an optimal manner that promotes the right to health of all individuals.”

Thus, countries that are lagging far behind in cervical cancer education, screening, and treatment should consider opting for a one-dose regimen for girls aged 9-14 years, as well as using additional resources to close the gap in these other areas.

Dr. Markman has relationships with Genentech, AstraZeneca, Celgene, Clovis, and Amgen; he is also a regular contributor to Medscape Oncology with the Markamn on Oncology video column. Dr. D’Souza and Dr. Nderitu have disclosed no relevant financial relationships.

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

INDIANAPOLIS – When adolescents present with acne that is not responding to isotretinoin, make sure to ask if they’re taking the medication when eating fatty food – which is known to increase the drug’s bioavailability, advises James R. Treat, MD, a pediatric dermatologist at Children’s Hospital of Philadelphia.

“We see lots of teenagers who are on a restrictive diet,” which is “certainly one reason they could be failing isotretinoin,” Dr. Treat said at the annual meeting of the Society for Pediatric Dermatology.

Often, patients say that they have been referred to him because they had no response to 20 mg or 30 mg per day of isotretinoin. But after a dose escalation to 60 mg per day, their acne worsened.

If the patient’s acne is worsening with a cystic flare, “tripling the dose of isotretinoin is not something that you should do,” Dr. Treat said. “You should lower the dose and consider adding steroids.” For evidence-based recommendations on managing acne fulminans, he recommended an article published in the Journal of the American Academy of Dermatology in 2017.

Skin picking is another common reason for failure of isotretinoin, as well as with other acne therapies. These patients may have associated anxiety, which “might be a contraindication or at least something to consider before you put them on isotretinoin,” he noted.

In his experience, off-label use of N-acetylcysteine, an antioxidant and cysteine prodrug, has been “extremely effective” for patients with excoriation disorder. In a randomized trial of adults 18-60 years of age, 47% patients who took 1,200-3,000 mg per day doses of N-acetylcysteine for 12 weeks reported that their skin picking was much or very much improved, compared to 19% of those who took placebo (P = .03). The authors wrote that N-acetylcysteine “increases extracellular levels of glutamate in the nucleus accumbens,” and that these results support the hypothesis that “pharmacologic manipulation of the glutamate system may target core symptoms of compulsive behaviors.”

The tumor necrosis factor (TNF)-alpha blocker adalimumab is a reasonable option for patients with severe cystic inflammatory acne who fail isotretinoin, Dr. Treat said. In one published case, clinicians administered adalimumab 40 mg every other week for a 16-year-old male patient who received isotretinoin for moderate acne vulgaris, which caused sudden development of acne fulminans and incapacitating acute sacroiliitis with bilateral hip arthritis. Inflammatory lesions started to clear in 1 month and comedones improved by 3 months of treatment. Adalimumab was discontinued after 1 year and the patient remained clear.

“There are now multiple reports as well as some case series showing TNF-alpha agents causing clearance of acne,” said Dr. Treat, who directs the hospital’s pediatric dermatology fellowship program. A literature review of adalimumab, etanercept, and infliximab for treatment-resistant acne found that all agents had similar efficacy after 3-6 months of therapy. “We see this in our GI population, where TNF-alpha agents are helping their acne also,” he said. “We just have to augment it with some topical medications.”

Certain medications can drive the development of acne, including phenytoin, phenobarbital, lithium, MEK inhibitors, EGFR inhibitors, systemic steroids, and unopposed progesterone contraceptives. Some genetic conditions also predispose patients to acne, including mutations in the NCSTN gene and trisomy 13.

Dr. Treat discussed one of his patients with severe acne who had trisomy 13. The patient failed 12 months of doxycycline and amoxicillin in combination with a topical retinoid. He also failed low- and high-dose isotretinoin in combination with prednisone, as well as oral dapsone at a dose of 1 mg/kg per day for 3 months. He was started on adalimumab, but that was stopped after he flared. The patient is now maintained on ustekinumab monthly at a dose of 45 mg.

“I’ve only had a few patients where isotretinoin truly has failed,” Dr. Treat said. He described one patient with severe acne who had a hidradenitis-like appearance in his axilla and groin. “I treated with isotretinoin very gingerly in the beginning, [but] he flared significantly. I had given him concomitant steroids from the very beginning and transitioned to multiple different therapies – all of which failed.”

Next, Dr. Treat tried a course of systemic dapsone, and the patient responded nicely. “As an anti-inflammatory agent, dapsone is very reasonable” to consider, he said. “It’s something to add to your armamentarium.”

Dr. Treat disclosed that he is a consultant for Palvella and Regeneron. He has ownership interests in Matinas Biopharma Holdings, Axsome, Sorrento, and Amarin.

INDIANAPOLIS – When adolescents present with acne that is not responding to isotretinoin, make sure to ask if they’re taking the medication when eating fatty food – which is known to increase the drug’s bioavailability, advises James R. Treat, MD, a pediatric dermatologist at Children’s Hospital of Philadelphia.

“We see lots of teenagers who are on a restrictive diet,” which is “certainly one reason they could be failing isotretinoin,” Dr. Treat said at the annual meeting of the Society for Pediatric Dermatology.

Often, patients say that they have been referred to him because they had no response to 20 mg or 30 mg per day of isotretinoin. But after a dose escalation to 60 mg per day, their acne worsened.

If the patient’s acne is worsening with a cystic flare, “tripling the dose of isotretinoin is not something that you should do,” Dr. Treat said. “You should lower the dose and consider adding steroids.” For evidence-based recommendations on managing acne fulminans, he recommended an article published in the Journal of the American Academy of Dermatology in 2017.

Skin picking is another common reason for failure of isotretinoin, as well as with other acne therapies. These patients may have associated anxiety, which “might be a contraindication or at least something to consider before you put them on isotretinoin,” he noted.

In his experience, off-label use of N-acetylcysteine, an antioxidant and cysteine prodrug, has been “extremely effective” for patients with excoriation disorder. In a randomized trial of adults 18-60 years of age, 47% patients who took 1,200-3,000 mg per day doses of N-acetylcysteine for 12 weeks reported that their skin picking was much or very much improved, compared to 19% of those who took placebo (P = .03). The authors wrote that N-acetylcysteine “increases extracellular levels of glutamate in the nucleus accumbens,” and that these results support the hypothesis that “pharmacologic manipulation of the glutamate system may target core symptoms of compulsive behaviors.”

The tumor necrosis factor (TNF)-alpha blocker adalimumab is a reasonable option for patients with severe cystic inflammatory acne who fail isotretinoin, Dr. Treat said. In one published case, clinicians administered adalimumab 40 mg every other week for a 16-year-old male patient who received isotretinoin for moderate acne vulgaris, which caused sudden development of acne fulminans and incapacitating acute sacroiliitis with bilateral hip arthritis. Inflammatory lesions started to clear in 1 month and comedones improved by 3 months of treatment. Adalimumab was discontinued after 1 year and the patient remained clear.

“There are now multiple reports as well as some case series showing TNF-alpha agents causing clearance of acne,” said Dr. Treat, who directs the hospital’s pediatric dermatology fellowship program. A literature review of adalimumab, etanercept, and infliximab for treatment-resistant acne found that all agents had similar efficacy after 3-6 months of therapy. “We see this in our GI population, where TNF-alpha agents are helping their acne also,” he said. “We just have to augment it with some topical medications.”

Certain medications can drive the development of acne, including phenytoin, phenobarbital, lithium, MEK inhibitors, EGFR inhibitors, systemic steroids, and unopposed progesterone contraceptives. Some genetic conditions also predispose patients to acne, including mutations in the NCSTN gene and trisomy 13.

Dr. Treat discussed one of his patients with severe acne who had trisomy 13. The patient failed 12 months of doxycycline and amoxicillin in combination with a topical retinoid. He also failed low- and high-dose isotretinoin in combination with prednisone, as well as oral dapsone at a dose of 1 mg/kg per day for 3 months. He was started on adalimumab, but that was stopped after he flared. The patient is now maintained on ustekinumab monthly at a dose of 45 mg.

“I’ve only had a few patients where isotretinoin truly has failed,” Dr. Treat said. He described one patient with severe acne who had a hidradenitis-like appearance in his axilla and groin. “I treated with isotretinoin very gingerly in the beginning, [but] he flared significantly. I had given him concomitant steroids from the very beginning and transitioned to multiple different therapies – all of which failed.”

Next, Dr. Treat tried a course of systemic dapsone, and the patient responded nicely. “As an anti-inflammatory agent, dapsone is very reasonable” to consider, he said. “It’s something to add to your armamentarium.”

Dr. Treat disclosed that he is a consultant for Palvella and Regeneron. He has ownership interests in Matinas Biopharma Holdings, Axsome, Sorrento, and Amarin.

INDIANAPOLIS – When adolescents present with acne that is not responding to isotretinoin, make sure to ask if they’re taking the medication when eating fatty food – which is known to increase the drug’s bioavailability, advises James R. Treat, MD, a pediatric dermatologist at Children’s Hospital of Philadelphia.

“We see lots of teenagers who are on a restrictive diet,” which is “certainly one reason they could be failing isotretinoin,” Dr. Treat said at the annual meeting of the Society for Pediatric Dermatology.

Often, patients say that they have been referred to him because they had no response to 20 mg or 30 mg per day of isotretinoin. But after a dose escalation to 60 mg per day, their acne worsened.

If the patient’s acne is worsening with a cystic flare, “tripling the dose of isotretinoin is not something that you should do,” Dr. Treat said. “You should lower the dose and consider adding steroids.” For evidence-based recommendations on managing acne fulminans, he recommended an article published in the Journal of the American Academy of Dermatology in 2017.

Skin picking is another common reason for failure of isotretinoin, as well as with other acne therapies. These patients may have associated anxiety, which “might be a contraindication or at least something to consider before you put them on isotretinoin,” he noted.

In his experience, off-label use of N-acetylcysteine, an antioxidant and cysteine prodrug, has been “extremely effective” for patients with excoriation disorder. In a randomized trial of adults 18-60 years of age, 47% patients who took 1,200-3,000 mg per day doses of N-acetylcysteine for 12 weeks reported that their skin picking was much or very much improved, compared to 19% of those who took placebo (P = .03). The authors wrote that N-acetylcysteine “increases extracellular levels of glutamate in the nucleus accumbens,” and that these results support the hypothesis that “pharmacologic manipulation of the glutamate system may target core symptoms of compulsive behaviors.”

The tumor necrosis factor (TNF)-alpha blocker adalimumab is a reasonable option for patients with severe cystic inflammatory acne who fail isotretinoin, Dr. Treat said. In one published case, clinicians administered adalimumab 40 mg every other week for a 16-year-old male patient who received isotretinoin for moderate acne vulgaris, which caused sudden development of acne fulminans and incapacitating acute sacroiliitis with bilateral hip arthritis. Inflammatory lesions started to clear in 1 month and comedones improved by 3 months of treatment. Adalimumab was discontinued after 1 year and the patient remained clear.

“There are now multiple reports as well as some case series showing TNF-alpha agents causing clearance of acne,” said Dr. Treat, who directs the hospital’s pediatric dermatology fellowship program. A literature review of adalimumab, etanercept, and infliximab for treatment-resistant acne found that all agents had similar efficacy after 3-6 months of therapy. “We see this in our GI population, where TNF-alpha agents are helping their acne also,” he said. “We just have to augment it with some topical medications.”

Certain medications can drive the development of acne, including phenytoin, phenobarbital, lithium, MEK inhibitors, EGFR inhibitors, systemic steroids, and unopposed progesterone contraceptives. Some genetic conditions also predispose patients to acne, including mutations in the NCSTN gene and trisomy 13.

Dr. Treat discussed one of his patients with severe acne who had trisomy 13. The patient failed 12 months of doxycycline and amoxicillin in combination with a topical retinoid. He also failed low- and high-dose isotretinoin in combination with prednisone, as well as oral dapsone at a dose of 1 mg/kg per day for 3 months. He was started on adalimumab, but that was stopped after he flared. The patient is now maintained on ustekinumab monthly at a dose of 45 mg.

“I’ve only had a few patients where isotretinoin truly has failed,” Dr. Treat said. He described one patient with severe acne who had a hidradenitis-like appearance in his axilla and groin. “I treated with isotretinoin very gingerly in the beginning, [but] he flared significantly. I had given him concomitant steroids from the very beginning and transitioned to multiple different therapies – all of which failed.”

Next, Dr. Treat tried a course of systemic dapsone, and the patient responded nicely. “As an anti-inflammatory agent, dapsone is very reasonable” to consider, he said. “It’s something to add to your armamentarium.”

Dr. Treat disclosed that he is a consultant for Palvella and Regeneron. He has ownership interests in Matinas Biopharma Holdings, Axsome, Sorrento, and Amarin.

Researchers from France have identified two distinct phenotypes of fulminant COVID-19–related myocarditis in adults, with different clinical presentations, immunologic profiles, and outcomes.

Differentiation between the two bioclinical entities is important to understand for patient management and further pathophysiological studies, they said.

The first phenotype occurs early (within a few days) in acute SARS-CoV-2 infection, with active viral replication (polymerase chain reaction positive) in adults who meet criteria for multisystem inflammatory syndrome (MIS-A+).

Floaria Bicher/iStock/Getty Images Plus

In this early phenotype, there is “limited systemic inflammation without skin and mucosal involvement, but myocardial dysfunction is fulminant and frequently associated with large pericardial effusions. These cases more often require extracorporeal membrane oxygenation [ECMO],” Guy Gorochov, MD, PhD, Sorbonne University, Paris, said in an interview.

The second is a delayed, postinfectious, immune-driven phenotype that occurs in adults who fail to meet the criteria for MIS-A (MIS-A–).

This phenotype occurs weeks after SARS-CoV-2 infection, usually beyond detectable active viral replication (PCR–) in the context of specific immune response and severe systemic inflammation with skin and mucosal involvement. Myocardial dysfunction is more progressive and rarely associated with large pericardial effusions, Dr. Gorochov explained.

The study was published in the Journal of the American College of Cardiology.
 

Evolving understanding

The findings are based on a retrospective analysis of 38 patients without a history of COVID-19 vaccination who were admitted to the intensive care unit from March 2020 to June 2021 for suspected fulminant COVID-19 myocarditis.

Patients were confirmed to have SARS-CoV-2 infection by PCR and/or by serologic testing. As noted in other studies, the patients were predominantly young men (66%; median age, 27.5 years). Twenty-five (66%) patients were MIS-A+ and 13 (34%) were MIS-A–.

In general, the MIS-A– patients were sicker and had worse outcomes.

Specifically, compared with the MIS-A+ patients, MIS-A– patients had a shorter time between the onset of COVID-19 symptoms and the development of myocarditis, a shorter time to ICU admission, and more severe presentations assessed using lower left ventricular ejection fraction and sequential organ failure assessment scores.

MIS-A– patients also had higher lactate levels, were more likely to need venoarterial ECMO (92% vs 16%), had higher ICU mortality (31% vs. 4%), and a had lower probability of survival at 3 months (68% vs. 96%), compared with their MIS-A+ peers.

Immunologic differences

The immunologic profiles of these two distinct clinical phenotypes also differed.

In MIS-A– early-type COVID-19 myocarditis, RNA polymerase III autoantibodies are frequently positive and serum levels of antiviral interferon-alpha and granulocyte-attracting interleukin-8 are elevated.

In contrast, in MIS-A+ delayed-type COVID-19 myocarditis, RNA polymerase III autoantibodies are negative and serum levels of IL-17 and IL-22 are highly elevated.

“We suggest that IL-17 and IL-22 are novel criteria that should help to assess in adults the recently recognized MIS-A,” Dr. Gorochov told this news organization. “It should be tested whether IL-17 and IL-22 are also elevated in children with MIS-C.”

The researchers also observed “extremely” high serum IL-10 levels in both patient groups. This has been previously associated with severe myocardial injury and an increase in the risk for death in severe COVID-19 patients.

The researchers said the phenotypic clustering of patients with fulminant COVID-19–related myocarditis “seems relevant” for their management.

MIS-A– cases, owing to the high risk for evolution toward refractory cardiogenic shock, should be “urgently” referred to a center with venoarterial ECMO and closely monitored to prevent a “too-late” cannulation, especially under cardiopulmonary resuscitation, known to be associated with poor outcomes, they advised.

They noted that the five patients who died in their series had late venoarterial ECMO implantation, while undergoing multiple organ failures or resuscitation.

Conversely, the risk for evolution to refractory cardiogenic shock is lower in MIS-A+ cases. However, identifying MIS-A+ cases is “all the more important given that numerous data support the efficacy of corticosteroids and/or intravenous immunoglobulins in MIS-C,” Dr. Gorochov and colleagues wrote.

The authors of a linked editorial said the French team should be “commended on their work in furthering our understanding of fulminant myocarditis related to COVID-19 infection.”

Ajith Nair, MD, Baylor College of Medicine, and Anita Deswal, MD, MPH, University of Texas M.D. Anderson Cancer Center, both in Houston, noted that fulminant myocarditis is rare and can result from either of two mechanisms: viral tropism or an immune-mediated mechanism.

“It remains to be seen whether using antiviral therapy versus immunomodulatory therapy on the basis of clinical and cytokine profiles will yield benefits,” they wrote.

“Fulminant myocarditis invariably requires hemodynamic support and carries a high mortality risk if it is recognized late. However, the long-term prognosis in patients who survive the critical period is favorable, with recovery of myocardial function,” they added.

“This study highlights the ever-shifting understanding of the pathophysiology and therapeutic approaches to fulminant myocarditis,” Dr. Nair and Dr. Deswal concluded.

This research was supported in part by the Foundation of France, French National Research Agency, Sorbonne University, and Clinical Research Hospital. The researchers have filed a patent application based on these results. Dr. Nair and Dr. Deswal have no relevant disclosures.

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

Researchers from France have identified two distinct phenotypes of fulminant COVID-19–related myocarditis in adults, with different clinical presentations, immunologic profiles, and outcomes.

Differentiation between the two bioclinical entities is important to understand for patient management and further pathophysiological studies, they said.

The first phenotype occurs early (within a few days) in acute SARS-CoV-2 infection, with active viral replication (polymerase chain reaction positive) in adults who meet criteria for multisystem inflammatory syndrome (MIS-A+).

Floaria Bicher/iStock/Getty Images Plus

In this early phenotype, there is “limited systemic inflammation without skin and mucosal involvement, but myocardial dysfunction is fulminant and frequently associated with large pericardial effusions. These cases more often require extracorporeal membrane oxygenation [ECMO],” Guy Gorochov, MD, PhD, Sorbonne University, Paris, said in an interview.

The second is a delayed, postinfectious, immune-driven phenotype that occurs in adults who fail to meet the criteria for MIS-A (MIS-A–).

This phenotype occurs weeks after SARS-CoV-2 infection, usually beyond detectable active viral replication (PCR–) in the context of specific immune response and severe systemic inflammation with skin and mucosal involvement. Myocardial dysfunction is more progressive and rarely associated with large pericardial effusions, Dr. Gorochov explained.

The study was published in the Journal of the American College of Cardiology.
 

Evolving understanding

The findings are based on a retrospective analysis of 38 patients without a history of COVID-19 vaccination who were admitted to the intensive care unit from March 2020 to June 2021 for suspected fulminant COVID-19 myocarditis.

Patients were confirmed to have SARS-CoV-2 infection by PCR and/or by serologic testing. As noted in other studies, the patients were predominantly young men (66%; median age, 27.5 years). Twenty-five (66%) patients were MIS-A+ and 13 (34%) were MIS-A–.

In general, the MIS-A– patients were sicker and had worse outcomes.

Specifically, compared with the MIS-A+ patients, MIS-A– patients had a shorter time between the onset of COVID-19 symptoms and the development of myocarditis, a shorter time to ICU admission, and more severe presentations assessed using lower left ventricular ejection fraction and sequential organ failure assessment scores.

MIS-A– patients also had higher lactate levels, were more likely to need venoarterial ECMO (92% vs 16%), had higher ICU mortality (31% vs. 4%), and a had lower probability of survival at 3 months (68% vs. 96%), compared with their MIS-A+ peers.

Immunologic differences

The immunologic profiles of these two distinct clinical phenotypes also differed.

In MIS-A– early-type COVID-19 myocarditis, RNA polymerase III autoantibodies are frequently positive and serum levels of antiviral interferon-alpha and granulocyte-attracting interleukin-8 are elevated.

In contrast, in MIS-A+ delayed-type COVID-19 myocarditis, RNA polymerase III autoantibodies are negative and serum levels of IL-17 and IL-22 are highly elevated.

“We suggest that IL-17 and IL-22 are novel criteria that should help to assess in adults the recently recognized MIS-A,” Dr. Gorochov told this news organization. “It should be tested whether IL-17 and IL-22 are also elevated in children with MIS-C.”

The researchers also observed “extremely” high serum IL-10 levels in both patient groups. This has been previously associated with severe myocardial injury and an increase in the risk for death in severe COVID-19 patients.

The researchers said the phenotypic clustering of patients with fulminant COVID-19–related myocarditis “seems relevant” for their management.

MIS-A– cases, owing to the high risk for evolution toward refractory cardiogenic shock, should be “urgently” referred to a center with venoarterial ECMO and closely monitored to prevent a “too-late” cannulation, especially under cardiopulmonary resuscitation, known to be associated with poor outcomes, they advised.

They noted that the five patients who died in their series had late venoarterial ECMO implantation, while undergoing multiple organ failures or resuscitation.

Conversely, the risk for evolution to refractory cardiogenic shock is lower in MIS-A+ cases. However, identifying MIS-A+ cases is “all the more important given that numerous data support the efficacy of corticosteroids and/or intravenous immunoglobulins in MIS-C,” Dr. Gorochov and colleagues wrote.

The authors of a linked editorial said the French team should be “commended on their work in furthering our understanding of fulminant myocarditis related to COVID-19 infection.”

Ajith Nair, MD, Baylor College of Medicine, and Anita Deswal, MD, MPH, University of Texas M.D. Anderson Cancer Center, both in Houston, noted that fulminant myocarditis is rare and can result from either of two mechanisms: viral tropism or an immune-mediated mechanism.

“It remains to be seen whether using antiviral therapy versus immunomodulatory therapy on the basis of clinical and cytokine profiles will yield benefits,” they wrote.

“Fulminant myocarditis invariably requires hemodynamic support and carries a high mortality risk if it is recognized late. However, the long-term prognosis in patients who survive the critical period is favorable, with recovery of myocardial function,” they added.

“This study highlights the ever-shifting understanding of the pathophysiology and therapeutic approaches to fulminant myocarditis,” Dr. Nair and Dr. Deswal concluded.

This research was supported in part by the Foundation of France, French National Research Agency, Sorbonne University, and Clinical Research Hospital. The researchers have filed a patent application based on these results. Dr. Nair and Dr. Deswal have no relevant disclosures.

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

Researchers from France have identified two distinct phenotypes of fulminant COVID-19–related myocarditis in adults, with different clinical presentations, immunologic profiles, and outcomes.

Differentiation between the two bioclinical entities is important to understand for patient management and further pathophysiological studies, they said.

The first phenotype occurs early (within a few days) in acute SARS-CoV-2 infection, with active viral replication (polymerase chain reaction positive) in adults who meet criteria for multisystem inflammatory syndrome (MIS-A+).

Floaria Bicher/iStock/Getty Images Plus

In this early phenotype, there is “limited systemic inflammation without skin and mucosal involvement, but myocardial dysfunction is fulminant and frequently associated with large pericardial effusions. These cases more often require extracorporeal membrane oxygenation [ECMO],” Guy Gorochov, MD, PhD, Sorbonne University, Paris, said in an interview.

The second is a delayed, postinfectious, immune-driven phenotype that occurs in adults who fail to meet the criteria for MIS-A (MIS-A–).

This phenotype occurs weeks after SARS-CoV-2 infection, usually beyond detectable active viral replication (PCR–) in the context of specific immune response and severe systemic inflammation with skin and mucosal involvement. Myocardial dysfunction is more progressive and rarely associated with large pericardial effusions, Dr. Gorochov explained.

The study was published in the Journal of the American College of Cardiology.
 

Evolving understanding

The findings are based on a retrospective analysis of 38 patients without a history of COVID-19 vaccination who were admitted to the intensive care unit from March 2020 to June 2021 for suspected fulminant COVID-19 myocarditis.

Patients were confirmed to have SARS-CoV-2 infection by PCR and/or by serologic testing. As noted in other studies, the patients were predominantly young men (66%; median age, 27.5 years). Twenty-five (66%) patients were MIS-A+ and 13 (34%) were MIS-A–.

In general, the MIS-A– patients were sicker and had worse outcomes.

Specifically, compared with the MIS-A+ patients, MIS-A– patients had a shorter time between the onset of COVID-19 symptoms and the development of myocarditis, a shorter time to ICU admission, and more severe presentations assessed using lower left ventricular ejection fraction and sequential organ failure assessment scores.

MIS-A– patients also had higher lactate levels, were more likely to need venoarterial ECMO (92% vs 16%), had higher ICU mortality (31% vs. 4%), and a had lower probability of survival at 3 months (68% vs. 96%), compared with their MIS-A+ peers.

Immunologic differences

The immunologic profiles of these two distinct clinical phenotypes also differed.

In MIS-A– early-type COVID-19 myocarditis, RNA polymerase III autoantibodies are frequently positive and serum levels of antiviral interferon-alpha and granulocyte-attracting interleukin-8 are elevated.

In contrast, in MIS-A+ delayed-type COVID-19 myocarditis, RNA polymerase III autoantibodies are negative and serum levels of IL-17 and IL-22 are highly elevated.

“We suggest that IL-17 and IL-22 are novel criteria that should help to assess in adults the recently recognized MIS-A,” Dr. Gorochov told this news organization. “It should be tested whether IL-17 and IL-22 are also elevated in children with MIS-C.”

The researchers also observed “extremely” high serum IL-10 levels in both patient groups. This has been previously associated with severe myocardial injury and an increase in the risk for death in severe COVID-19 patients.

The researchers said the phenotypic clustering of patients with fulminant COVID-19–related myocarditis “seems relevant” for their management.

MIS-A– cases, owing to the high risk for evolution toward refractory cardiogenic shock, should be “urgently” referred to a center with venoarterial ECMO and closely monitored to prevent a “too-late” cannulation, especially under cardiopulmonary resuscitation, known to be associated with poor outcomes, they advised.

They noted that the five patients who died in their series had late venoarterial ECMO implantation, while undergoing multiple organ failures or resuscitation.

Conversely, the risk for evolution to refractory cardiogenic shock is lower in MIS-A+ cases. However, identifying MIS-A+ cases is “all the more important given that numerous data support the efficacy of corticosteroids and/or intravenous immunoglobulins in MIS-C,” Dr. Gorochov and colleagues wrote.

The authors of a linked editorial said the French team should be “commended on their work in furthering our understanding of fulminant myocarditis related to COVID-19 infection.”

Ajith Nair, MD, Baylor College of Medicine, and Anita Deswal, MD, MPH, University of Texas M.D. Anderson Cancer Center, both in Houston, noted that fulminant myocarditis is rare and can result from either of two mechanisms: viral tropism or an immune-mediated mechanism.

“It remains to be seen whether using antiviral therapy versus immunomodulatory therapy on the basis of clinical and cytokine profiles will yield benefits,” they wrote.

“Fulminant myocarditis invariably requires hemodynamic support and carries a high mortality risk if it is recognized late. However, the long-term prognosis in patients who survive the critical period is favorable, with recovery of myocardial function,” they added.

“This study highlights the ever-shifting understanding of the pathophysiology and therapeutic approaches to fulminant myocarditis,” Dr. Nair and Dr. Deswal concluded.

This research was supported in part by the Foundation of France, French National Research Agency, Sorbonne University, and Clinical Research Hospital. The researchers have filed a patent application based on these results. Dr. Nair and Dr. Deswal have no relevant disclosures.

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

Pediatric obesity is a serious problem, not only in the United States but worldwide. Unfortunately, the ongoing COVID-19 pandemic has worsened the epidemic of childhood obesity. Solutions for treating the millions of children and adolescents with obesity are desperately needed because prevention efforts over the past several decades have not been sufficient in slowing the steady rise in obesity prevalence.

Lifestyle modification, including dietary changes, increases in activity, and behavioral modification, are the cornerstone of any obesity treatment, but they alone are not powerful enough to treat obesity by itself in the vast majority of children and adolescents. This is because obesity is not a lifestyle choice; rather, it is a disease, and a disease that has a tremendous amount of biology driving individuals toward weight gain and the propensity toward weight regain if weight is lost.

Fortunately, the tools to treat the underlying biology driving obesity are becoming safer, more effective, and more widely used every year. The two most effective biology-based treatments for pediatric obesity are antiobesity medications and bariatric surgery. These two treatments, when accompanied by lifestyle modification, have the potential to reduce not only body weight but also treat many other risk factors, such as prediabetes, diabetes, high blood pressure, poor cholesterol, liver disease, and sleep apnea, as well as others.
 

Rise in antiobesity medications

Antiobesity medications are developing at a rapid pace. Seven medications have been approved by the Food and Drug Administration for adults, and three medications (phentermine, orlistat, and liraglutide) are now approved for children and adolescents.

The number of antiobesity medications for use in children and adolescents is expected to expand to five, with semaglutide and phentermine-topiramate (Qsymia) both completing trials in adolescents in 2022. Each of these medications works by treating the biology that drives weight gain, whether it is decreasing impulsivity, reducing hunger and appetite hormone pathways, or improving energy regulation pathways. Weight loss at 1 year for currently FDA-approved medications in adolescents ranges from 3% to 6% on average, depending on the medications. The newer medications already FDA approved in adults that will soon, hopefully, be available in pediatrics result in 10%-16% weight loss on average.

A common parent and patient question regarding antiobesity medications is: “If I start an antiobesity medication, how long will I need to be on it?” The simple answer is: “Probably for the rest of your life.”

This can be a shock to hear, but obesity treatment is very similar to that of hypertension or diabetes. Using high blood pressure as an example: If a patient has high blood pressure (for example, 160/90 mm Hg), they will be prescribed a medication to treat it. Once blood pressure comes down to near-normal levels (for example, 120/80 mm Hg), a dose will be maintained, not removed, because that is the biological mediator keeping the blood pressure low. Removal of the medication would result in blood pressure going back to homeostasis (160/90 mm Hg in our example) in a short period of time).

The same can be said for obesity. For example, if a 16-year-old girl is prescribed liraglutide, a glucagonlike peptide–1 receptor agonist, and loses 10% of her body weight at 1 year, that is great success. Why would we remove the medication that is treating the underlying biology causing successful weight loss?

In short, we would not want to do that. Even if our example patient only maintained that 10% initial weight loss, that would be very successful, just like someone maintaining their low blood pressure. As medications begin to develop at a rapid pace and become more available to pediatric patients, the messaging and conversation around anti-obesity medications must continue to focus on obesity being a biological disease and not a behavior for treatment to be effective and not stigmatized.
 

Bariatric surgery most effective treatment for pediatric obesity

Currently, the most effective treatment for pediatric obesity is bariatric surgery. The two most commonly used surgical procedures today are the sleeve gastrectomy and gastric bypass. Sleeve gastrectomy works by removing 75%-85% of the stomach and creating a new stomach, called a “sleeve.” Gastric bypass works by separating the stomach into two parts and connecting one part of the new stomach into the intestine.

Both surgeries are very effective at treating obesity in adolescents, with an average weight loss of 30%-35%. Surgery is not just a restrictive means of controlling body weight; it also changes key hormones for appetite and satiety that signal the brain. In fact, many of the same biological signals that are changed by surgery are the same signals being targeted by antiobesity medications. Long-term outcome of bariatric surgery in adolescents, provided by Teen-LABS, show it to be safe and maybe even more effective than in adults for treating diabetes and hypertension, with similar weight loss.
 

Does treatment outweigh the potential risks?

Although obesity surgery and antiobesity medications are more successful at treating obesity in children and adolescents than lifestyle medications, they do have some risks. Surgery, depending on the type of surgery, can cause nutritional deficiencies, reduce body mineral density, and is a life-changing medical procedure. Antiobesity medications, depending on the type, can cause nausea and vomiting and increase heart rate – and because they are relatively new, we do not fully understand the long-term impact of continued use past 1 year.

However, an important question to ask is: “Do the risks of obesity surgery and antiobesity medications outweigh the risk of having lifelong obesity?” The answer to me and many of my colleagues is: “Yes!” Although there are risks associated with the two best treatments for pediatric obesity, those risks under proper supervision of a medical professional far outweigh the risks of not properly treating obesity and allowing it to persist and get worse over many years to come. Obesity is a disease deeply rooted in biology, and we must use biology-based treatments to tackle this problem in children and adolescents, who deserve the best care and treatments possible.

Dr. Ryder is assistant professor of pediatrics and associate director of research, Center for Pediatric Obesity Medicine, at the University of Minnesota, Minneapolis. She reported receiving donations for clinical trials from Boehringer Ingelheim. A version of this article first appeared on Medscape.com.

Pediatric obesity is a serious problem, not only in the United States but worldwide. Unfortunately, the ongoing COVID-19 pandemic has worsened the epidemic of childhood obesity. Solutions for treating the millions of children and adolescents with obesity are desperately needed because prevention efforts over the past several decades have not been sufficient in slowing the steady rise in obesity prevalence.

Lifestyle modification, including dietary changes, increases in activity, and behavioral modification, are the cornerstone of any obesity treatment, but they alone are not powerful enough to treat obesity by itself in the vast majority of children and adolescents. This is because obesity is not a lifestyle choice; rather, it is a disease, and a disease that has a tremendous amount of biology driving individuals toward weight gain and the propensity toward weight regain if weight is lost.

Fortunately, the tools to treat the underlying biology driving obesity are becoming safer, more effective, and more widely used every year. The two most effective biology-based treatments for pediatric obesity are antiobesity medications and bariatric surgery. These two treatments, when accompanied by lifestyle modification, have the potential to reduce not only body weight but also treat many other risk factors, such as prediabetes, diabetes, high blood pressure, poor cholesterol, liver disease, and sleep apnea, as well as others.
 

Rise in antiobesity medications

Antiobesity medications are developing at a rapid pace. Seven medications have been approved by the Food and Drug Administration for adults, and three medications (phentermine, orlistat, and liraglutide) are now approved for children and adolescents.

The number of antiobesity medications for use in children and adolescents is expected to expand to five, with semaglutide and phentermine-topiramate (Qsymia) both completing trials in adolescents in 2022. Each of these medications works by treating the biology that drives weight gain, whether it is decreasing impulsivity, reducing hunger and appetite hormone pathways, or improving energy regulation pathways. Weight loss at 1 year for currently FDA-approved medications in adolescents ranges from 3% to 6% on average, depending on the medications. The newer medications already FDA approved in adults that will soon, hopefully, be available in pediatrics result in 10%-16% weight loss on average.

A common parent and patient question regarding antiobesity medications is: “If I start an antiobesity medication, how long will I need to be on it?” The simple answer is: “Probably for the rest of your life.”

This can be a shock to hear, but obesity treatment is very similar to that of hypertension or diabetes. Using high blood pressure as an example: If a patient has high blood pressure (for example, 160/90 mm Hg), they will be prescribed a medication to treat it. Once blood pressure comes down to near-normal levels (for example, 120/80 mm Hg), a dose will be maintained, not removed, because that is the biological mediator keeping the blood pressure low. Removal of the medication would result in blood pressure going back to homeostasis (160/90 mm Hg in our example) in a short period of time).

The same can be said for obesity. For example, if a 16-year-old girl is prescribed liraglutide, a glucagonlike peptide–1 receptor agonist, and loses 10% of her body weight at 1 year, that is great success. Why would we remove the medication that is treating the underlying biology causing successful weight loss?

In short, we would not want to do that. Even if our example patient only maintained that 10% initial weight loss, that would be very successful, just like someone maintaining their low blood pressure. As medications begin to develop at a rapid pace and become more available to pediatric patients, the messaging and conversation around anti-obesity medications must continue to focus on obesity being a biological disease and not a behavior for treatment to be effective and not stigmatized.
 

Bariatric surgery most effective treatment for pediatric obesity

Currently, the most effective treatment for pediatric obesity is bariatric surgery. The two most commonly used surgical procedures today are the sleeve gastrectomy and gastric bypass. Sleeve gastrectomy works by removing 75%-85% of the stomach and creating a new stomach, called a “sleeve.” Gastric bypass works by separating the stomach into two parts and connecting one part of the new stomach into the intestine.

Both surgeries are very effective at treating obesity in adolescents, with an average weight loss of 30%-35%. Surgery is not just a restrictive means of controlling body weight; it also changes key hormones for appetite and satiety that signal the brain. In fact, many of the same biological signals that are changed by surgery are the same signals being targeted by antiobesity medications. Long-term outcome of bariatric surgery in adolescents, provided by Teen-LABS, show it to be safe and maybe even more effective than in adults for treating diabetes and hypertension, with similar weight loss.
 

Does treatment outweigh the potential risks?

Although obesity surgery and antiobesity medications are more successful at treating obesity in children and adolescents than lifestyle medications, they do have some risks. Surgery, depending on the type of surgery, can cause nutritional deficiencies, reduce body mineral density, and is a life-changing medical procedure. Antiobesity medications, depending on the type, can cause nausea and vomiting and increase heart rate – and because they are relatively new, we do not fully understand the long-term impact of continued use past 1 year.

However, an important question to ask is: “Do the risks of obesity surgery and antiobesity medications outweigh the risk of having lifelong obesity?” The answer to me and many of my colleagues is: “Yes!” Although there are risks associated with the two best treatments for pediatric obesity, those risks under proper supervision of a medical professional far outweigh the risks of not properly treating obesity and allowing it to persist and get worse over many years to come. Obesity is a disease deeply rooted in biology, and we must use biology-based treatments to tackle this problem in children and adolescents, who deserve the best care and treatments possible.

Dr. Ryder is assistant professor of pediatrics and associate director of research, Center for Pediatric Obesity Medicine, at the University of Minnesota, Minneapolis. She reported receiving donations for clinical trials from Boehringer Ingelheim. A version of this article first appeared on Medscape.com.

Pediatric obesity is a serious problem, not only in the United States but worldwide. Unfortunately, the ongoing COVID-19 pandemic has worsened the epidemic of childhood obesity. Solutions for treating the millions of children and adolescents with obesity are desperately needed because prevention efforts over the past several decades have not been sufficient in slowing the steady rise in obesity prevalence.

Lifestyle modification, including dietary changes, increases in activity, and behavioral modification, are the cornerstone of any obesity treatment, but they alone are not powerful enough to treat obesity by itself in the vast majority of children and adolescents. This is because obesity is not a lifestyle choice; rather, it is a disease, and a disease that has a tremendous amount of biology driving individuals toward weight gain and the propensity toward weight regain if weight is lost.

Fortunately, the tools to treat the underlying biology driving obesity are becoming safer, more effective, and more widely used every year. The two most effective biology-based treatments for pediatric obesity are antiobesity medications and bariatric surgery. These two treatments, when accompanied by lifestyle modification, have the potential to reduce not only body weight but also treat many other risk factors, such as prediabetes, diabetes, high blood pressure, poor cholesterol, liver disease, and sleep apnea, as well as others.
 

Rise in antiobesity medications

Antiobesity medications are developing at a rapid pace. Seven medications have been approved by the Food and Drug Administration for adults, and three medications (phentermine, orlistat, and liraglutide) are now approved for children and adolescents.

The number of antiobesity medications for use in children and adolescents is expected to expand to five, with semaglutide and phentermine-topiramate (Qsymia) both completing trials in adolescents in 2022. Each of these medications works by treating the biology that drives weight gain, whether it is decreasing impulsivity, reducing hunger and appetite hormone pathways, or improving energy regulation pathways. Weight loss at 1 year for currently FDA-approved medications in adolescents ranges from 3% to 6% on average, depending on the medications. The newer medications already FDA approved in adults that will soon, hopefully, be available in pediatrics result in 10%-16% weight loss on average.

A common parent and patient question regarding antiobesity medications is: “If I start an antiobesity medication, how long will I need to be on it?” The simple answer is: “Probably for the rest of your life.”

This can be a shock to hear, but obesity treatment is very similar to that of hypertension or diabetes. Using high blood pressure as an example: If a patient has high blood pressure (for example, 160/90 mm Hg), they will be prescribed a medication to treat it. Once blood pressure comes down to near-normal levels (for example, 120/80 mm Hg), a dose will be maintained, not removed, because that is the biological mediator keeping the blood pressure low. Removal of the medication would result in blood pressure going back to homeostasis (160/90 mm Hg in our example) in a short period of time).

The same can be said for obesity. For example, if a 16-year-old girl is prescribed liraglutide, a glucagonlike peptide–1 receptor agonist, and loses 10% of her body weight at 1 year, that is great success. Why would we remove the medication that is treating the underlying biology causing successful weight loss?

In short, we would not want to do that. Even if our example patient only maintained that 10% initial weight loss, that would be very successful, just like someone maintaining their low blood pressure. As medications begin to develop at a rapid pace and become more available to pediatric patients, the messaging and conversation around anti-obesity medications must continue to focus on obesity being a biological disease and not a behavior for treatment to be effective and not stigmatized.
 

Bariatric surgery most effective treatment for pediatric obesity

Currently, the most effective treatment for pediatric obesity is bariatric surgery. The two most commonly used surgical procedures today are the sleeve gastrectomy and gastric bypass. Sleeve gastrectomy works by removing 75%-85% of the stomach and creating a new stomach, called a “sleeve.” Gastric bypass works by separating the stomach into two parts and connecting one part of the new stomach into the intestine.

Both surgeries are very effective at treating obesity in adolescents, with an average weight loss of 30%-35%. Surgery is not just a restrictive means of controlling body weight; it also changes key hormones for appetite and satiety that signal the brain. In fact, many of the same biological signals that are changed by surgery are the same signals being targeted by antiobesity medications. Long-term outcome of bariatric surgery in adolescents, provided by Teen-LABS, show it to be safe and maybe even more effective than in adults for treating diabetes and hypertension, with similar weight loss.
 

Does treatment outweigh the potential risks?

Although obesity surgery and antiobesity medications are more successful at treating obesity in children and adolescents than lifestyle medications, they do have some risks. Surgery, depending on the type of surgery, can cause nutritional deficiencies, reduce body mineral density, and is a life-changing medical procedure. Antiobesity medications, depending on the type, can cause nausea and vomiting and increase heart rate – and because they are relatively new, we do not fully understand the long-term impact of continued use past 1 year.

However, an important question to ask is: “Do the risks of obesity surgery and antiobesity medications outweigh the risk of having lifelong obesity?” The answer to me and many of my colleagues is: “Yes!” Although there are risks associated with the two best treatments for pediatric obesity, those risks under proper supervision of a medical professional far outweigh the risks of not properly treating obesity and allowing it to persist and get worse over many years to come. Obesity is a disease deeply rooted in biology, and we must use biology-based treatments to tackle this problem in children and adolescents, who deserve the best care and treatments possible.

Dr. Ryder is assistant professor of pediatrics and associate director of research, Center for Pediatric Obesity Medicine, at the University of Minnesota, Minneapolis. She reported receiving donations for clinical trials from Boehringer Ingelheim. A version of this article first appeared on Medscape.com.

The Supreme Court decision to strike down the 50-year ruling on Roe v. Wade, which allowed legal abortion, will affect all patients and families seeking care in pediatric and adolescent medicine clinics. Regardless of how you view abortion, the reality is your adolescent female patients and their parents will seek your counsel.

The overturning of Roe has resulted in much confusion for both patients and providers. The overall effect of this decision in Wisconsin is yet to be known but currently we have had to create road maps to direct adolescent patients who experience an unplanned pregnancy and wish to abort. Unfortunately, these road maps include only resources out of state or online. Providing adolescents confidential care may be challenged as the teens may need to disclose the unplanned pregnancy to an adult to access resources.

Providers remain unsettled regarding their risk of assisting an adolescent who discloses an unplanned pregnancy. Recently, many questions arose regarding dispensing Plan B and the risk to prescribers. Communication was needed to assure providers that Plan B is contraception and at this time contraception remains legal in our state.

Daily I educate adolescent females on the risks of unplanned pregnancy and what the Supreme Court decision will mean to them if they become pregnant. Unfortunately, many teens do not understand the ruling and how this decision affects them personally. Education is needed today more than ever regarding pregnancy prevention.

The recent AAP policy statement reaffirms its position that the rights of adolescents to seek confidential care when considering abortion must be protected.¹ It further reaffirms access to safe and legal abortion is a core tenant of sexual and reproductive health care.

A recent article published in AAP News by Elise D. Berlan, MD, “AAP’s teen reproductive health policies reaffirm right to comprehensive care,” further advises on the role of the pediatric provider.² Pediatric providers should continue offering option counseling for pregnant adolescents, be prepared to provide accurate information regarding these options with awareness that some options such as the IUD may no longer be available, remain supportive of the decision they choose, and encourage discussion with a family member to support their decisions. It is imperative that we familiarize ourselves with the abortion policies in our states, advocate to prevent government interference with the patient-doctor relationship, and recognize the impact restrictive abortion has regarding marginalized individuals, she stated. Finally we must recognize our own bias regarding option counseling and refer appropriately to another professional if we are unable to confidently offer guidance.

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee.

References

1. AAP Committee on Adolescence. Pediatrics. 2022. doi: 10.1542/peds.2022-058780.

2. Berlan ED. AAP’s teen reproductive health policies reaffirm right to comprehensive care. 2022. AAP News.

The Supreme Court decision to strike down the 50-year ruling on Roe v. Wade, which allowed legal abortion, will affect all patients and families seeking care in pediatric and adolescent medicine clinics. Regardless of how you view abortion, the reality is your adolescent female patients and their parents will seek your counsel.

The overturning of Roe has resulted in much confusion for both patients and providers. The overall effect of this decision in Wisconsin is yet to be known but currently we have had to create road maps to direct adolescent patients who experience an unplanned pregnancy and wish to abort. Unfortunately, these road maps include only resources out of state or online. Providing adolescents confidential care may be challenged as the teens may need to disclose the unplanned pregnancy to an adult to access resources.

Providers remain unsettled regarding their risk of assisting an adolescent who discloses an unplanned pregnancy. Recently, many questions arose regarding dispensing Plan B and the risk to prescribers. Communication was needed to assure providers that Plan B is contraception and at this time contraception remains legal in our state.

Daily I educate adolescent females on the risks of unplanned pregnancy and what the Supreme Court decision will mean to them if they become pregnant. Unfortunately, many teens do not understand the ruling and how this decision affects them personally. Education is needed today more than ever regarding pregnancy prevention.

The recent AAP policy statement reaffirms its position that the rights of adolescents to seek confidential care when considering abortion must be protected.¹ It further reaffirms access to safe and legal abortion is a core tenant of sexual and reproductive health care.

A recent article published in AAP News by Elise D. Berlan, MD, “AAP’s teen reproductive health policies reaffirm right to comprehensive care,” further advises on the role of the pediatric provider.² Pediatric providers should continue offering option counseling for pregnant adolescents, be prepared to provide accurate information regarding these options with awareness that some options such as the IUD may no longer be available, remain supportive of the decision they choose, and encourage discussion with a family member to support their decisions. It is imperative that we familiarize ourselves with the abortion policies in our states, advocate to prevent government interference with the patient-doctor relationship, and recognize the impact restrictive abortion has regarding marginalized individuals, she stated. Finally we must recognize our own bias regarding option counseling and refer appropriately to another professional if we are unable to confidently offer guidance.

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee.

References

1. AAP Committee on Adolescence. Pediatrics. 2022. doi: 10.1542/peds.2022-058780.

2. Berlan ED. AAP’s teen reproductive health policies reaffirm right to comprehensive care. 2022. AAP News.

The Supreme Court decision to strike down the 50-year ruling on Roe v. Wade, which allowed legal abortion, will affect all patients and families seeking care in pediatric and adolescent medicine clinics. Regardless of how you view abortion, the reality is your adolescent female patients and their parents will seek your counsel.

The overturning of Roe has resulted in much confusion for both patients and providers. The overall effect of this decision in Wisconsin is yet to be known but currently we have had to create road maps to direct adolescent patients who experience an unplanned pregnancy and wish to abort. Unfortunately, these road maps include only resources out of state or online. Providing adolescents confidential care may be challenged as the teens may need to disclose the unplanned pregnancy to an adult to access resources.

Providers remain unsettled regarding their risk of assisting an adolescent who discloses an unplanned pregnancy. Recently, many questions arose regarding dispensing Plan B and the risk to prescribers. Communication was needed to assure providers that Plan B is contraception and at this time contraception remains legal in our state.

Daily I educate adolescent females on the risks of unplanned pregnancy and what the Supreme Court decision will mean to them if they become pregnant. Unfortunately, many teens do not understand the ruling and how this decision affects them personally. Education is needed today more than ever regarding pregnancy prevention.

The recent AAP policy statement reaffirms its position that the rights of adolescents to seek confidential care when considering abortion must be protected.¹ It further reaffirms access to safe and legal abortion is a core tenant of sexual and reproductive health care.

A recent article published in AAP News by Elise D. Berlan, MD, “AAP’s teen reproductive health policies reaffirm right to comprehensive care,” further advises on the role of the pediatric provider.² Pediatric providers should continue offering option counseling for pregnant adolescents, be prepared to provide accurate information regarding these options with awareness that some options such as the IUD may no longer be available, remain supportive of the decision they choose, and encourage discussion with a family member to support their decisions. It is imperative that we familiarize ourselves with the abortion policies in our states, advocate to prevent government interference with the patient-doctor relationship, and recognize the impact restrictive abortion has regarding marginalized individuals, she stated. Finally we must recognize our own bias regarding option counseling and refer appropriately to another professional if we are unable to confidently offer guidance.

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee.

References

1. AAP Committee on Adolescence. Pediatrics. 2022. doi: 10.1542/peds.2022-058780.

2. Berlan ED. AAP’s teen reproductive health policies reaffirm right to comprehensive care. 2022. AAP News.