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With coronavirus disease (COVID-19) reaching epidemic proportions, many US children are growing increasingly anxious about what this means for their own health and safety and that of their friends and family.

The constantly changing numbers of people affected by the virus and the evolving situation mean daily life for many children is affected in some way, with school trips, sports tournaments, and family vacations being postponed or canceled.

All children may have a heightened level of worry, and some who are normally anxious might be obsessing more about handwashing or getting sick.

Experts say there are ways to manage this fear to help children feel safe and appropriately informed.

Clinicians and other adults should provide children with honest and accurate information geared to their age and developmental level, said David Fassler, MD, clinical professor of psychiatry, University of Vermont Larner College of Medicine, Burlington, and member of the Consumer Issues Committee of the American Academy of Child and Adolescent Psychiatry.

That said, it’s also acceptable to let children know that some questions can’t be answered, said Fassler.
 

Be truthful, calm

“This is partly because the information keeps changing as we learn more about how the virus spreads, how to best protect communities, and how to treat people who get sick,” he added.

Clinicians and parents should remind children “that there are a lot of adults who are working very hard to keep them safe,” said Eli R. Lebowitz, PhD, associate professor in the Child Study Center, Yale School of Medicine, New Haven, Connecticut, who directs a program for anxiety.

It’s important for adults to pay attention not only to what they say to children but also how they say it, said Lebowitz. He highlighted the importance of talking about the virus “in a calm and matter-of-fact way” rather than in an anxious way.

“If you look scared or tense or your voice is conveying that you’re really scared, the child is going to absorb that and feel anxious as well,” he noted.

This advice also applies when adults are discussing the issue among themselves. They should be aware that “children are listening” and are picking up any anxiety or panic adults are expressing.

Children are soaking up information about this virus from the Internet, the media, friends, teachers, and elsewhere. Lebowitz suggests asking children what they have already heard, which provides an opportunity to correct rumors and inaccurate information.

“A child might have a very inflated sense of what the actual risk is. For example, they may think that anyone who gets the virus dies,” he said.
 

Myth busting

Adults should let children know that not everything they hear from friends or on the Internet “is necessarily correct,” he added.

Some children who have experienced serious illness or losses may be particularly vulnerable to experiencing intense reactions to graphic news reports or images of illness or death and may need extra support, said Fassler.

Adults could use the “framework of knowledge” that children already have, said Lebowitz. He noted that all children are aware of sickness.

“They know people get sick, and they themselves have probably been sick, so you can tell them that this is a sickness like a bad flu,” he said.

Children should be encouraged to approach adults they trust, such as their pediatrician, a parent, or a teacher, with their questions, said Lebowitz. “Those are the people who are able to give them the most accurate information.”

Fassler noted that accurate, up-to-date information is available via fact sheets developed by the Centers for Disease Control and Prevention and the World Health Organization.

Although it’s helpful and appropriate to be reassuring, Fassler advises not to make unrealistic promises.

“It’s fine to tell kids that you’ll deal with whatever happens, even if it means altering travel plans or work schedules, but you can’t promise that no one in your state or community will get sick,” he said.
 

Maintain healthy habits

Physicians and other adults can tell children “in an age-appropriate way” how the virus is transmitted and what the symptoms are, but it’s important to emphasize that most people who are sick don’t have COVID-19, said Lebowitz.

“I would emphasize that the people who are the sickest are the elderly who are already sick, rather than healthy younger people,” he said.

Lebowitz recommends continuing to follow guidelines on staying healthy, including coughing into a sleeve instead of your hand and regular handwashing.

It’s also important at this time for children to maintain healthy habits – getting enough physical activity and sleep, eating well, and being outside – because this regime will go a long way toward reducing anxiety, said Lebowitz. Deep breathing and muscle-relaxing exercises can also help, he said.

Lebowitz also suggests maintaining a supportive attitude and showing “some acceptance and validation of what children are feeling, as well as some confidence that they can cope and tolerate feeling uncomfortable sometimes, that they can handle some anxiety.”

While accepting that the child could be anxious, it’s important not to encourage excessive avoidance or unhealthy coping strategies. Fassler and Lebowitz agree that children who are overly anxious or preoccupied with concerns about the coronavirus should be evaluated by a trained, qualified mental health professional.

Signs that a child may need additional help include ongoing sleep difficulties, intrusive thoughts or worries, obsessive-compulsive behaviors, or reluctance or refusal to go to school, said Fassler.

The good news is that most children are resilient, said Fassler. “They’ll adjust, adapt, and go on with their lives.”

This article first appeared on Medscape.com.

With coronavirus disease (COVID-19) reaching epidemic proportions, many US children are growing increasingly anxious about what this means for their own health and safety and that of their friends and family.

The constantly changing numbers of people affected by the virus and the evolving situation mean daily life for many children is affected in some way, with school trips, sports tournaments, and family vacations being postponed or canceled.

All children may have a heightened level of worry, and some who are normally anxious might be obsessing more about handwashing or getting sick.

Experts say there are ways to manage this fear to help children feel safe and appropriately informed.

Clinicians and other adults should provide children with honest and accurate information geared to their age and developmental level, said David Fassler, MD, clinical professor of psychiatry, University of Vermont Larner College of Medicine, Burlington, and member of the Consumer Issues Committee of the American Academy of Child and Adolescent Psychiatry.

That said, it’s also acceptable to let children know that some questions can’t be answered, said Fassler.
 

Be truthful, calm

“This is partly because the information keeps changing as we learn more about how the virus spreads, how to best protect communities, and how to treat people who get sick,” he added.

Clinicians and parents should remind children “that there are a lot of adults who are working very hard to keep them safe,” said Eli R. Lebowitz, PhD, associate professor in the Child Study Center, Yale School of Medicine, New Haven, Connecticut, who directs a program for anxiety.

It’s important for adults to pay attention not only to what they say to children but also how they say it, said Lebowitz. He highlighted the importance of talking about the virus “in a calm and matter-of-fact way” rather than in an anxious way.

“If you look scared or tense or your voice is conveying that you’re really scared, the child is going to absorb that and feel anxious as well,” he noted.

This advice also applies when adults are discussing the issue among themselves. They should be aware that “children are listening” and are picking up any anxiety or panic adults are expressing.

Children are soaking up information about this virus from the Internet, the media, friends, teachers, and elsewhere. Lebowitz suggests asking children what they have already heard, which provides an opportunity to correct rumors and inaccurate information.

“A child might have a very inflated sense of what the actual risk is. For example, they may think that anyone who gets the virus dies,” he said.
 

Myth busting

Adults should let children know that not everything they hear from friends or on the Internet “is necessarily correct,” he added.

Some children who have experienced serious illness or losses may be particularly vulnerable to experiencing intense reactions to graphic news reports or images of illness or death and may need extra support, said Fassler.

Adults could use the “framework of knowledge” that children already have, said Lebowitz. He noted that all children are aware of sickness.

“They know people get sick, and they themselves have probably been sick, so you can tell them that this is a sickness like a bad flu,” he said.

Children should be encouraged to approach adults they trust, such as their pediatrician, a parent, or a teacher, with their questions, said Lebowitz. “Those are the people who are able to give them the most accurate information.”

Fassler noted that accurate, up-to-date information is available via fact sheets developed by the Centers for Disease Control and Prevention and the World Health Organization.

Although it’s helpful and appropriate to be reassuring, Fassler advises not to make unrealistic promises.

“It’s fine to tell kids that you’ll deal with whatever happens, even if it means altering travel plans or work schedules, but you can’t promise that no one in your state or community will get sick,” he said.
 

Maintain healthy habits

Physicians and other adults can tell children “in an age-appropriate way” how the virus is transmitted and what the symptoms are, but it’s important to emphasize that most people who are sick don’t have COVID-19, said Lebowitz.

“I would emphasize that the people who are the sickest are the elderly who are already sick, rather than healthy younger people,” he said.

Lebowitz recommends continuing to follow guidelines on staying healthy, including coughing into a sleeve instead of your hand and regular handwashing.

It’s also important at this time for children to maintain healthy habits – getting enough physical activity and sleep, eating well, and being outside – because this regime will go a long way toward reducing anxiety, said Lebowitz. Deep breathing and muscle-relaxing exercises can also help, he said.

Lebowitz also suggests maintaining a supportive attitude and showing “some acceptance and validation of what children are feeling, as well as some confidence that they can cope and tolerate feeling uncomfortable sometimes, that they can handle some anxiety.”

While accepting that the child could be anxious, it’s important not to encourage excessive avoidance or unhealthy coping strategies. Fassler and Lebowitz agree that children who are overly anxious or preoccupied with concerns about the coronavirus should be evaluated by a trained, qualified mental health professional.

Signs that a child may need additional help include ongoing sleep difficulties, intrusive thoughts or worries, obsessive-compulsive behaviors, or reluctance or refusal to go to school, said Fassler.

The good news is that most children are resilient, said Fassler. “They’ll adjust, adapt, and go on with their lives.”

This article first appeared on Medscape.com.

With coronavirus disease (COVID-19) reaching epidemic proportions, many US children are growing increasingly anxious about what this means for their own health and safety and that of their friends and family.

The constantly changing numbers of people affected by the virus and the evolving situation mean daily life for many children is affected in some way, with school trips, sports tournaments, and family vacations being postponed or canceled.

All children may have a heightened level of worry, and some who are normally anxious might be obsessing more about handwashing or getting sick.

Experts say there are ways to manage this fear to help children feel safe and appropriately informed.

Clinicians and other adults should provide children with honest and accurate information geared to their age and developmental level, said David Fassler, MD, clinical professor of psychiatry, University of Vermont Larner College of Medicine, Burlington, and member of the Consumer Issues Committee of the American Academy of Child and Adolescent Psychiatry.

That said, it’s also acceptable to let children know that some questions can’t be answered, said Fassler.
 

Be truthful, calm

“This is partly because the information keeps changing as we learn more about how the virus spreads, how to best protect communities, and how to treat people who get sick,” he added.

Clinicians and parents should remind children “that there are a lot of adults who are working very hard to keep them safe,” said Eli R. Lebowitz, PhD, associate professor in the Child Study Center, Yale School of Medicine, New Haven, Connecticut, who directs a program for anxiety.

It’s important for adults to pay attention not only to what they say to children but also how they say it, said Lebowitz. He highlighted the importance of talking about the virus “in a calm and matter-of-fact way” rather than in an anxious way.

“If you look scared or tense or your voice is conveying that you’re really scared, the child is going to absorb that and feel anxious as well,” he noted.

This advice also applies when adults are discussing the issue among themselves. They should be aware that “children are listening” and are picking up any anxiety or panic adults are expressing.

Children are soaking up information about this virus from the Internet, the media, friends, teachers, and elsewhere. Lebowitz suggests asking children what they have already heard, which provides an opportunity to correct rumors and inaccurate information.

“A child might have a very inflated sense of what the actual risk is. For example, they may think that anyone who gets the virus dies,” he said.
 

Myth busting

Adults should let children know that not everything they hear from friends or on the Internet “is necessarily correct,” he added.

Some children who have experienced serious illness or losses may be particularly vulnerable to experiencing intense reactions to graphic news reports or images of illness or death and may need extra support, said Fassler.

Adults could use the “framework of knowledge” that children already have, said Lebowitz. He noted that all children are aware of sickness.

“They know people get sick, and they themselves have probably been sick, so you can tell them that this is a sickness like a bad flu,” he said.

Children should be encouraged to approach adults they trust, such as their pediatrician, a parent, or a teacher, with their questions, said Lebowitz. “Those are the people who are able to give them the most accurate information.”

Fassler noted that accurate, up-to-date information is available via fact sheets developed by the Centers for Disease Control and Prevention and the World Health Organization.

Although it’s helpful and appropriate to be reassuring, Fassler advises not to make unrealistic promises.

“It’s fine to tell kids that you’ll deal with whatever happens, even if it means altering travel plans or work schedules, but you can’t promise that no one in your state or community will get sick,” he said.
 

Maintain healthy habits

Physicians and other adults can tell children “in an age-appropriate way” how the virus is transmitted and what the symptoms are, but it’s important to emphasize that most people who are sick don’t have COVID-19, said Lebowitz.

“I would emphasize that the people who are the sickest are the elderly who are already sick, rather than healthy younger people,” he said.

Lebowitz recommends continuing to follow guidelines on staying healthy, including coughing into a sleeve instead of your hand and regular handwashing.

It’s also important at this time for children to maintain healthy habits – getting enough physical activity and sleep, eating well, and being outside – because this regime will go a long way toward reducing anxiety, said Lebowitz. Deep breathing and muscle-relaxing exercises can also help, he said.

Lebowitz also suggests maintaining a supportive attitude and showing “some acceptance and validation of what children are feeling, as well as some confidence that they can cope and tolerate feeling uncomfortable sometimes, that they can handle some anxiety.”

While accepting that the child could be anxious, it’s important not to encourage excessive avoidance or unhealthy coping strategies. Fassler and Lebowitz agree that children who are overly anxious or preoccupied with concerns about the coronavirus should be evaluated by a trained, qualified mental health professional.

Signs that a child may need additional help include ongoing sleep difficulties, intrusive thoughts or worries, obsessive-compulsive behaviors, or reluctance or refusal to go to school, said Fassler.

The good news is that most children are resilient, said Fassler. “They’ll adjust, adapt, and go on with their lives.”

This article first appeared on Medscape.com.

The U.S. Supreme Court will likely decide by the end of the summer whether a controversial Louisiana abortion law that imposes restrictions on physicians can stand.

AndreyPopov/ThinkStock

Justices heard oral arguments March 4, 2020, in June Medicare Services v. Russo, which centers on a Louisiana law requiring physicians who perform abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, while clinics that violate the law can have their licenses revoked, according to the state law, originally passed in 2014. In 2016, the Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, the justices struck down the measure as unconstitutional.

During oral arguments, Julie Rikelman an attorney representing June Medical Services, said that the Louisiana law is identical to the abortion law in Texas, and she argued that justices should reach the same conclusion.

“The district court found this law would leave Louisiana with just one clinic in one state to serve about 10,000 people per year,” Ms. Rikelman said during oral arguments. “That would mean that hundreds of thousands of women would now live more than 150 miles from the closest provider. And the burdens were actually more severe than this court found in Whole Woman’s Health.”

Elizabeth Murrill, solicitor general of Louisiana, argued that the Louisiana law was justified, and that the 5th U.S. Circuit Court of Appeals was correct when it reversed a district court decision and upheld the law.

“The 5th Circuit correctly held that the plaintiffs in this case failed to carry their burden – their heavy burden of proof that is required to facially invalidate a state law,” Ms. Murrill said during oral arguments. “Louisiana’s decision to require abortion providers to have admitting privileges was justified by abundant evidence of life-threatening health and safety violations, malpractice, noncompliance with professional licensing rules, legislative testimony from postabortive women, [and] testimony from doctors who took care of abortion providers’ abandoned patients.”

During arguments, Justice Ruth Bader Ginsburg questioned the reasoning behind the 30-mile privileges rule, expressing doubt at the state’s justification for the requirement. “What sense does the 30-mile limit make, considering that – certainly for medication abortions and for the overwhelming number of other abortions ... if the woman has a problem, it will be her local hospital that ... she will need to go to for the care, not something 30 miles from the clinic.”

Ms. Murrill responded that the Louisiana regulation is consistent with surgery and ambulatory surgery regulations and aligns with the state’s regulatory structure.

“We had evidence in the record of women who did require transfers,” Ms. Murrill said. “[An abortion provider] testified unambiguously that he had to transfer four patients who had punctured uteruses and were hemorrhaging.”

Whether the plaintiffs have standing to sue is a key question. As a general rule, a plaintiff can only sue to protect their own rights, unless the plaintiff has a close relationship with a third party and there are barriers that prevent the third party from suing. Attorneys for Louisiana contend that the plaintiffs – the medical clinic and several physicians – have no right to sue because their rights are not at stake, and that there is no obstacle to patients suing over the law.

Since the Louisiana law is intended to protect women from “unscrupulous and incompetent abortion providers,” the state argues also that there is a conflict of interest between the physicians and the patients on whose behalf they are suing.

During arguments, Justice Samuel Alito Jr. repeatedly questioned Ms. Rikelman on the plaintiffs’ right to sue, conveying doubt that the plaintiffs were on solid legal ground.

“Would you agree with the general proposition that a party should not be able to sue ostensibly to protect the rights of other people, if there is a real conflict of interest between the party who is suing and those whose rights the party claims to be attempting to defend?” Associate Justice Alito asked during oral arguments.

The hearing ended with no clear picture of how some justices were leaning. Justice Clarence Thomas and Justice Neil Gorsuch remained silent during arguments and asked no questions. Chief Justice John Roberts Jr., and Justice Brett Kavanaugh questioned whether all admitting privileges laws were unconstitutional or if a state-by-state analysis is required. Near the end of the hearing, Justice Stephen Breyer stressed that more research and fact-finding is necessary before the court can reach a decision.

“We’re not going to solve this at oral argument,” he said.

A decision by the Supreme Court is expected by August 2020.

agallegos@mdedge.com

The U.S. Supreme Court will likely decide by the end of the summer whether a controversial Louisiana abortion law that imposes restrictions on physicians can stand.

AndreyPopov/ThinkStock

Justices heard oral arguments March 4, 2020, in June Medicare Services v. Russo, which centers on a Louisiana law requiring physicians who perform abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, while clinics that violate the law can have their licenses revoked, according to the state law, originally passed in 2014. In 2016, the Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, the justices struck down the measure as unconstitutional.

During oral arguments, Julie Rikelman an attorney representing June Medical Services, said that the Louisiana law is identical to the abortion law in Texas, and she argued that justices should reach the same conclusion.

“The district court found this law would leave Louisiana with just one clinic in one state to serve about 10,000 people per year,” Ms. Rikelman said during oral arguments. “That would mean that hundreds of thousands of women would now live more than 150 miles from the closest provider. And the burdens were actually more severe than this court found in Whole Woman’s Health.”

Elizabeth Murrill, solicitor general of Louisiana, argued that the Louisiana law was justified, and that the 5th U.S. Circuit Court of Appeals was correct when it reversed a district court decision and upheld the law.

“The 5th Circuit correctly held that the plaintiffs in this case failed to carry their burden – their heavy burden of proof that is required to facially invalidate a state law,” Ms. Murrill said during oral arguments. “Louisiana’s decision to require abortion providers to have admitting privileges was justified by abundant evidence of life-threatening health and safety violations, malpractice, noncompliance with professional licensing rules, legislative testimony from postabortive women, [and] testimony from doctors who took care of abortion providers’ abandoned patients.”

During arguments, Justice Ruth Bader Ginsburg questioned the reasoning behind the 30-mile privileges rule, expressing doubt at the state’s justification for the requirement. “What sense does the 30-mile limit make, considering that – certainly for medication abortions and for the overwhelming number of other abortions ... if the woman has a problem, it will be her local hospital that ... she will need to go to for the care, not something 30 miles from the clinic.”

Ms. Murrill responded that the Louisiana regulation is consistent with surgery and ambulatory surgery regulations and aligns with the state’s regulatory structure.

“We had evidence in the record of women who did require transfers,” Ms. Murrill said. “[An abortion provider] testified unambiguously that he had to transfer four patients who had punctured uteruses and were hemorrhaging.”

Whether the plaintiffs have standing to sue is a key question. As a general rule, a plaintiff can only sue to protect their own rights, unless the plaintiff has a close relationship with a third party and there are barriers that prevent the third party from suing. Attorneys for Louisiana contend that the plaintiffs – the medical clinic and several physicians – have no right to sue because their rights are not at stake, and that there is no obstacle to patients suing over the law.

Since the Louisiana law is intended to protect women from “unscrupulous and incompetent abortion providers,” the state argues also that there is a conflict of interest between the physicians and the patients on whose behalf they are suing.

During arguments, Justice Samuel Alito Jr. repeatedly questioned Ms. Rikelman on the plaintiffs’ right to sue, conveying doubt that the plaintiffs were on solid legal ground.

“Would you agree with the general proposition that a party should not be able to sue ostensibly to protect the rights of other people, if there is a real conflict of interest between the party who is suing and those whose rights the party claims to be attempting to defend?” Associate Justice Alito asked during oral arguments.

The hearing ended with no clear picture of how some justices were leaning. Justice Clarence Thomas and Justice Neil Gorsuch remained silent during arguments and asked no questions. Chief Justice John Roberts Jr., and Justice Brett Kavanaugh questioned whether all admitting privileges laws were unconstitutional or if a state-by-state analysis is required. Near the end of the hearing, Justice Stephen Breyer stressed that more research and fact-finding is necessary before the court can reach a decision.

“We’re not going to solve this at oral argument,” he said.

A decision by the Supreme Court is expected by August 2020.

agallegos@mdedge.com

The U.S. Supreme Court will likely decide by the end of the summer whether a controversial Louisiana abortion law that imposes restrictions on physicians can stand.

AndreyPopov/ThinkStock

Justices heard oral arguments March 4, 2020, in June Medicare Services v. Russo, which centers on a Louisiana law requiring physicians who perform abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, while clinics that violate the law can have their licenses revoked, according to the state law, originally passed in 2014. In 2016, the Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, the justices struck down the measure as unconstitutional.

During oral arguments, Julie Rikelman an attorney representing June Medical Services, said that the Louisiana law is identical to the abortion law in Texas, and she argued that justices should reach the same conclusion.

“The district court found this law would leave Louisiana with just one clinic in one state to serve about 10,000 people per year,” Ms. Rikelman said during oral arguments. “That would mean that hundreds of thousands of women would now live more than 150 miles from the closest provider. And the burdens were actually more severe than this court found in Whole Woman’s Health.”

Elizabeth Murrill, solicitor general of Louisiana, argued that the Louisiana law was justified, and that the 5th U.S. Circuit Court of Appeals was correct when it reversed a district court decision and upheld the law.

“The 5th Circuit correctly held that the plaintiffs in this case failed to carry their burden – their heavy burden of proof that is required to facially invalidate a state law,” Ms. Murrill said during oral arguments. “Louisiana’s decision to require abortion providers to have admitting privileges was justified by abundant evidence of life-threatening health and safety violations, malpractice, noncompliance with professional licensing rules, legislative testimony from postabortive women, [and] testimony from doctors who took care of abortion providers’ abandoned patients.”

During arguments, Justice Ruth Bader Ginsburg questioned the reasoning behind the 30-mile privileges rule, expressing doubt at the state’s justification for the requirement. “What sense does the 30-mile limit make, considering that – certainly for medication abortions and for the overwhelming number of other abortions ... if the woman has a problem, it will be her local hospital that ... she will need to go to for the care, not something 30 miles from the clinic.”

Ms. Murrill responded that the Louisiana regulation is consistent with surgery and ambulatory surgery regulations and aligns with the state’s regulatory structure.

“We had evidence in the record of women who did require transfers,” Ms. Murrill said. “[An abortion provider] testified unambiguously that he had to transfer four patients who had punctured uteruses and were hemorrhaging.”

Whether the plaintiffs have standing to sue is a key question. As a general rule, a plaintiff can only sue to protect their own rights, unless the plaintiff has a close relationship with a third party and there are barriers that prevent the third party from suing. Attorneys for Louisiana contend that the plaintiffs – the medical clinic and several physicians – have no right to sue because their rights are not at stake, and that there is no obstacle to patients suing over the law.

Since the Louisiana law is intended to protect women from “unscrupulous and incompetent abortion providers,” the state argues also that there is a conflict of interest between the physicians and the patients on whose behalf they are suing.

During arguments, Justice Samuel Alito Jr. repeatedly questioned Ms. Rikelman on the plaintiffs’ right to sue, conveying doubt that the plaintiffs were on solid legal ground.

“Would you agree with the general proposition that a party should not be able to sue ostensibly to protect the rights of other people, if there is a real conflict of interest between the party who is suing and those whose rights the party claims to be attempting to defend?” Associate Justice Alito asked during oral arguments.

The hearing ended with no clear picture of how some justices were leaning. Justice Clarence Thomas and Justice Neil Gorsuch remained silent during arguments and asked no questions. Chief Justice John Roberts Jr., and Justice Brett Kavanaugh questioned whether all admitting privileges laws were unconstitutional or if a state-by-state analysis is required. Near the end of the hearing, Justice Stephen Breyer stressed that more research and fact-finding is necessary before the court can reach a decision.

“We’re not going to solve this at oral argument,” he said.

A decision by the Supreme Court is expected by August 2020.

agallegos@mdedge.com

When she was 4 months pregnant, Angela Crawley waited for 30 minutes in a private room to hear the results of her noninvasive prenatal testing. Her ultrasound had been flagged as high risk by the radiologist and she agreed to undergo further testing to gather information on the health of her unborn child.

As she waited for her genetic counseling appointment, she noticed somber expressions on the faces of her health team and picked up on hushed tones.

It had taken 2 years to become pregnant and the joy she felt attending prenatal care appointments was fading into a sense of dread as she sat in that small room and the minutes ticked by.

Crawley – a scientist in the chronic disease program at the Ottawa Hospital Research Institute, assistant professor at the University of Ottawa, and adjunct research professor at Carleton University in Ontario, Canada – is more qualified than most patients to absorb health information and make appropriate decisions.

And yet, “I was completely unprepared,” she told Medscape Medical News as she reflected on what she now refers to as some of the darkest days of her life. “It was a nightmare and it was such a confusing, scary time.”

Crawley is among the more than 6 million women from at least 90 countries who have undergone noninvasive prenatal testing. During pregnancy, a mother’s bloodstream contains a mix of cell-free DNA from her own cells and from placental cells, which is usually identical to the DNA of the fetus. Analysis of cell-free DNA can lead to the early detection of genetic disorders.

Testing is most often used to look for chromosomal disorders that are caused by the presence of an extra chromosome, like in trisomy 21 in the case of Down syndrome or extra or missing copies of the X and Y chromosomes in other disorders. The accuracy of the test tends to vary, depending on the condition being assessed.

Cell-free DNA testing has reduced the number of invasive prenatal diagnostic procedures, some of which can lead to miscarriage, and this noninvasive option made sense to Crawley and was covered by government health insurance.

With a market projected to surpass $13 billion by the year 2027, some experts speculate that prenatal genetic testing is the most rapidly adopted test in human history. Globally, noninvasive prenatal tests cost $500 to $3,000 for patients who pay out of pocket, and all those screening options are amassing valuable genetic data troves.

The pioneer of noninvasive prenatal testing, Dennis Lo, PhD, from the Chinese University of Hong Kong, told Medscape Medical News that the success of using cell-free DNA came after a long, winding road of rejected grant applications and scientific skepticism.

“Initially, people did not think this would be useful for assessing chromosomal abnormalities because the thinking at the time was that we would need to count them,” Lo said.

But he was enchanted by early glimpses of the capability of cell-free DNA, and felt driven to pursue unconventional research ideas even though there were significant hurdles to overcome in the lab.

“We were detecting fetal Y chromosomes in women. At first, it was just scientific curiosity,” said Lo. “At the time, people worried that fetal cells would persist from one pregnancy to the next, but we discovered that fetal DNA actually clears very quickly and does not progress into the next pregnancy,” he explained. “This is very important because it won’t alter the accuracy of the test.”

Gripped by the scientific mystery, the researcher put in long hours at the lab. “I’m fortunate I have a very understanding wife who is herself a scientist,” he said. After a particularly long stretch without quality time together, Lo and his spouse, Alice Wong, went to see a Harry Potter movie.

As Lo viewed the Harry Potter H through 3D glasses, he was suddenly reminded of the male human karyotype.

“I saw the vertical stripes of the H and it hit me,” he told Medscape Medical News. “There are two sets of chromosomes.” The average human karyotype contains 22 pairs of autosomal chromosomes and one pair of sex chromosomes.

“Our complex genetic conundrum was cracked in the middle of a Harry Potter movie in a moment when I felt completely relaxed,” he recalled. “My wife said: ‘You can’t even watch a movie properly.’ ”

Back at the lab, Lo shared his Harry Potter–inspired concept and the team got to work.

In December 2019, Lo received the Fudan-Zhongzhi Science Award in Shanghai from Nobel laureate physicist Samuel Chao Chung Ting, chair of the award committee. The prize honors fundamental and groundbreaking achievements in biomedicine, and the laureate receives ¥3 million (about U.S. $428,550), donated by Zhongzhi Enterprise Group.

This honor was 30 years in the making, Lo told Medscape Medical News. “I’m pleased to experience public recognition and this is a high honor in China,” he added.

“Noninvasive prenatal testing is better than anything we’ve ever had before,” said Ronald Wapner, MD, from the Columbia University Irving Medical Center in New York City, who taught a course on the transition of prenatal diagnostics from amniocentesis to whole-genome sequencing at the recent Society for Maternal–Fetal Medicine 2020 Annual Pregnancy Meeting.

“We now have the capability to improve healthcare decision-making in utero and at birth,” he told Medscape Medical News. “It’s remarkable.”

But, Wapner said, the market grew too fast. “The National Institutes of Health didn’t even play a role in these fast-paced developments. Traditional governing bodies and authorities were bypassed as cytogenetic labs marketed directly to physicians and patients,” he explained.

One of the major problems with the rapid uptake in testing is a lack of preparation for patients like Crawley.

The clinician who delivered her test results was not feeling well, so “she spoke through a surgical mask,” Crawley reported. “I was trying to understand what she was saying, but it was an uncomfortable exchange.”

Crawley had undergone prenatal genetic testing because her ultrasound had shown irregularities in fetal leg measurements. The genetic tests confirmed no anomalies in the chromosome count, but that was it.

“There was no prognosis, just vague numbers that no one seemed to know what to do with,” Crawley recalled.

With concern about growth measurements, the conversation moved quickly to options, including termination. Crawley said the dialogue felt jarring and moved too quickly for her to process all the information and possible courses of action.

She was told she could terminate and “try again to get pregnant.” But Crawley was 39 years old and had been trying to conceive for 2 years.

“It was devastating,” she said. “No one sat down with me before this appointment to learn about my values or preferences, and I left that conversation with more questions than I had before I arrived. I went home and had one the worst weekends of my life. My husband and I felt so overwhelmed, grieved, and alone.”

Pretest counseling can be as important as any subsequent genetic counseling, said Blair Stevens, a prenatal expert from the National Society of Genetic Counselors and a genetic counselor at the University of Texas Health Science Center in Houston.

“Information is valuable, but it can also be toxic, depending on what individuals intend to do with what they learn,” she explained. “We cannot unknow or unhear details, so it’s really important to work with patients in advance to make sure their preferences guide any planning.”

Uncertainty can be very unsettling, she acknowledged. “It’s important to help patients balance any ambiguity, so if there is a 20% risk, there is also an 80% chance of another, perhaps more favorable, outcome.”

Most clinicians don’t have the time to fully assess patient goals and align counseling approaches to individual needs, Stevens explained. And public interest in prenatal testing has outpaced clinical best practices as competing labs race to expand offerings and add options to screening tests to grab a piece of the global market, which is now about 130 million births per year.

“These are not scientifically sound additions and we need more evidence,” Stevens said. “There is a right way to handle this, and labs and clinicians need to collaborate on responsible methods to test and integrate expanding options.”
 

The blue and pink elephant in the room

“The reality is that most people don’t have a super high risk for chromosomal irregularities,” said Stevens. “Most people are more interested in learning the sex of their baby in early pregnancy than in any actual desire for genetic information.” Noninvasive prenatal testing can detect fetal sex as early as 9 weeks into a pregnancy, whereas ultrasound might not detect it until about 18 weeks.

“Honestly? I think the growing popularity of gender-reveal parties is what is actually driving the push for more prenatal testing,” she added. “The problem is that a couple eager to learn the sex of their baby may wind up with way more information than they expected and have trouble processing unanticipated risk.”

In February, five national medical organizations in the United States partnered with the Reproductive Genetics Technology Consortium to develop consensus recommendations and guidelines for prenatal genetic testing.

The National Society of Genetic Counselors and the Society for Maternal–Fetal Medicine are among the new members that will provide a forum through which commercial laboratories can communicate about new technologies and obtain input and guidance on emerging options.

Wapner, who is a member of the consortium, said he hopes thought leaders will be at the forefront to guide this next chapter of prenatal screening. “So much money is pouring into all this testing; let’s make sure we are making the right, most essential screening decisions,” he said.

“Science typically advances more rapidly than the ethical and legal framework to support decision-making, and it’s important for society to put protections in place,” Lo acknowledged.

The misuse of screening and unethical sex-selection efforts in Asia and elsewhere in the world, where males are highly valued and females are more likely to be aborted, is dismaying, he told Medscape Medical News. “These are exploitations of the science.”

In addition to scientific misuse like sex selection, data breaches are becoming a huge concern as companies amass large amounts of valuable genetic information.
 

Data for ransom

In Canada, where Crawley took her test, LifeLabs – the country’s largest laboratory testing company and a provider of genetic testing – paid a ransom after a major cyberattack led to the theft of lab results for 85,000 people in Ontario and the personal information of 15 million customers.

LifeLabs paid an undisclosed sum to retrieve the data, the company reported on December 17, and hired cybersecurity experts to assess the damage. The company is offering security protection services, including identity theft and fraud protection insurance, to customers.

“This has served as a reminder that we need to stay ahead of cybercrime, which has become a pervasive issue around the world in all sectors,” Charles Brown, president and chief executive officer of LifeLabs, wrote in a letter to customers. “You entrust us with important health information, and we take that responsibility very seriously.”

The United States has led the world in the commercial push for more prenatal testing. Other countries in Europe, for example, have proceeded with caution and have integrated the technologies with more controls. Hong Kong, where the inventor of the test is based, has been among the slowest to adopt the practice.

“I have been lobbying for 8 years for Hong Kong to offer testing,” said Lo. “I think Hong Kong has been too slow to integrate, but the United States probably moved too quickly. There is a balance that I think countries like the Netherlands have found; they take the aim of screening into account, along with justice and societal aspects.”

“Ideally, we will develop a great pretest model triage tool to help guide patients through this process,” Stevens said. “And we have to make sure the data they receive are clinically useful and backed up by evidence to safeguard the care of every patient.”

The practice of medicine is meticulously designed to assess and mitigate risk, “but this sensible objective can also be extremely negative in focus, with not-so-great delivery of information,” she acknowledged. Each individual’s tolerance for uncertainty and ability to cope in the face of adversity varies. “These are complex conversations that require time and empathy, and the details matter,” she added.

“In my home state of Texas, where there is a large religious base, there is not as much drive for advance prenatal genetic information,” Stevens explained. “We see a real advocacy movement emerging and a need for information from patients first because these can’t really be clinician-led decisions,” she pointed out. “Patients come to us undergoing not just the physical changes of pregnancy, but also emotional transformation as they transition to become parents. They may be nauseous or already sleep-deprived and they need our help,” she added.

Crawley could feel the fluttering of fetal movements in her womb and said she felt connected to her child, but she remembered her trip to Ireland when she and her husband drank too much and they likely conceived. Irrational thoughts crept in: “Maybe it was something we did. What about my swimming; could it have been harmful?”

Apprehensions lingered as she waited to meet her specialist. Would the child grow and be able to walk? Be held back by disabling joint pain? Crawley sat down with her doctor at the high-risk clinic to discuss the possibilities.

“I don’t see anything to be alarmed about. She’s probably going to be small,” said the obstetrician.

“She?!” Crawley had opted not to learn the sex of her baby, unlike so many other parents she knew, but her hope for her baby’s good health soared above the accidental disclosure.

“Everything changed in that moment,” Crawley said. “I knew that we were going to be okay no matter what happened next.”

Crawley’s pregnancy progressed to term and she gave birth to a healthy baby girl who is now 3 years old and dances ballet. Her beloved daughter is shorter than some of the other dancers in her class, but her mom says she hasn’t missed a beat. “The world is a better place because my daughter is in it,” Crawley said. “This, I know for sure.”

This article first appeared on Medscape.com.

When she was 4 months pregnant, Angela Crawley waited for 30 minutes in a private room to hear the results of her noninvasive prenatal testing. Her ultrasound had been flagged as high risk by the radiologist and she agreed to undergo further testing to gather information on the health of her unborn child.

As she waited for her genetic counseling appointment, she noticed somber expressions on the faces of her health team and picked up on hushed tones.

It had taken 2 years to become pregnant and the joy she felt attending prenatal care appointments was fading into a sense of dread as she sat in that small room and the minutes ticked by.

Crawley – a scientist in the chronic disease program at the Ottawa Hospital Research Institute, assistant professor at the University of Ottawa, and adjunct research professor at Carleton University in Ontario, Canada – is more qualified than most patients to absorb health information and make appropriate decisions.

And yet, “I was completely unprepared,” she told Medscape Medical News as she reflected on what she now refers to as some of the darkest days of her life. “It was a nightmare and it was such a confusing, scary time.”

Crawley is among the more than 6 million women from at least 90 countries who have undergone noninvasive prenatal testing. During pregnancy, a mother’s bloodstream contains a mix of cell-free DNA from her own cells and from placental cells, which is usually identical to the DNA of the fetus. Analysis of cell-free DNA can lead to the early detection of genetic disorders.

Testing is most often used to look for chromosomal disorders that are caused by the presence of an extra chromosome, like in trisomy 21 in the case of Down syndrome or extra or missing copies of the X and Y chromosomes in other disorders. The accuracy of the test tends to vary, depending on the condition being assessed.

Cell-free DNA testing has reduced the number of invasive prenatal diagnostic procedures, some of which can lead to miscarriage, and this noninvasive option made sense to Crawley and was covered by government health insurance.

With a market projected to surpass $13 billion by the year 2027, some experts speculate that prenatal genetic testing is the most rapidly adopted test in human history. Globally, noninvasive prenatal tests cost $500 to $3,000 for patients who pay out of pocket, and all those screening options are amassing valuable genetic data troves.

The pioneer of noninvasive prenatal testing, Dennis Lo, PhD, from the Chinese University of Hong Kong, told Medscape Medical News that the success of using cell-free DNA came after a long, winding road of rejected grant applications and scientific skepticism.

“Initially, people did not think this would be useful for assessing chromosomal abnormalities because the thinking at the time was that we would need to count them,” Lo said.

But he was enchanted by early glimpses of the capability of cell-free DNA, and felt driven to pursue unconventional research ideas even though there were significant hurdles to overcome in the lab.

“We were detecting fetal Y chromosomes in women. At first, it was just scientific curiosity,” said Lo. “At the time, people worried that fetal cells would persist from one pregnancy to the next, but we discovered that fetal DNA actually clears very quickly and does not progress into the next pregnancy,” he explained. “This is very important because it won’t alter the accuracy of the test.”

Gripped by the scientific mystery, the researcher put in long hours at the lab. “I’m fortunate I have a very understanding wife who is herself a scientist,” he said. After a particularly long stretch without quality time together, Lo and his spouse, Alice Wong, went to see a Harry Potter movie.

As Lo viewed the Harry Potter H through 3D glasses, he was suddenly reminded of the male human karyotype.

“I saw the vertical stripes of the H and it hit me,” he told Medscape Medical News. “There are two sets of chromosomes.” The average human karyotype contains 22 pairs of autosomal chromosomes and one pair of sex chromosomes.

“Our complex genetic conundrum was cracked in the middle of a Harry Potter movie in a moment when I felt completely relaxed,” he recalled. “My wife said: ‘You can’t even watch a movie properly.’ ”

Back at the lab, Lo shared his Harry Potter–inspired concept and the team got to work.

In December 2019, Lo received the Fudan-Zhongzhi Science Award in Shanghai from Nobel laureate physicist Samuel Chao Chung Ting, chair of the award committee. The prize honors fundamental and groundbreaking achievements in biomedicine, and the laureate receives ¥3 million (about U.S. $428,550), donated by Zhongzhi Enterprise Group.

This honor was 30 years in the making, Lo told Medscape Medical News. “I’m pleased to experience public recognition and this is a high honor in China,” he added.

“Noninvasive prenatal testing is better than anything we’ve ever had before,” said Ronald Wapner, MD, from the Columbia University Irving Medical Center in New York City, who taught a course on the transition of prenatal diagnostics from amniocentesis to whole-genome sequencing at the recent Society for Maternal–Fetal Medicine 2020 Annual Pregnancy Meeting.

“We now have the capability to improve healthcare decision-making in utero and at birth,” he told Medscape Medical News. “It’s remarkable.”

But, Wapner said, the market grew too fast. “The National Institutes of Health didn’t even play a role in these fast-paced developments. Traditional governing bodies and authorities were bypassed as cytogenetic labs marketed directly to physicians and patients,” he explained.

One of the major problems with the rapid uptake in testing is a lack of preparation for patients like Crawley.

The clinician who delivered her test results was not feeling well, so “she spoke through a surgical mask,” Crawley reported. “I was trying to understand what she was saying, but it was an uncomfortable exchange.”

Crawley had undergone prenatal genetic testing because her ultrasound had shown irregularities in fetal leg measurements. The genetic tests confirmed no anomalies in the chromosome count, but that was it.

“There was no prognosis, just vague numbers that no one seemed to know what to do with,” Crawley recalled.

With concern about growth measurements, the conversation moved quickly to options, including termination. Crawley said the dialogue felt jarring and moved too quickly for her to process all the information and possible courses of action.

She was told she could terminate and “try again to get pregnant.” But Crawley was 39 years old and had been trying to conceive for 2 years.

“It was devastating,” she said. “No one sat down with me before this appointment to learn about my values or preferences, and I left that conversation with more questions than I had before I arrived. I went home and had one the worst weekends of my life. My husband and I felt so overwhelmed, grieved, and alone.”

Pretest counseling can be as important as any subsequent genetic counseling, said Blair Stevens, a prenatal expert from the National Society of Genetic Counselors and a genetic counselor at the University of Texas Health Science Center in Houston.

“Information is valuable, but it can also be toxic, depending on what individuals intend to do with what they learn,” she explained. “We cannot unknow or unhear details, so it’s really important to work with patients in advance to make sure their preferences guide any planning.”

Uncertainty can be very unsettling, she acknowledged. “It’s important to help patients balance any ambiguity, so if there is a 20% risk, there is also an 80% chance of another, perhaps more favorable, outcome.”

Most clinicians don’t have the time to fully assess patient goals and align counseling approaches to individual needs, Stevens explained. And public interest in prenatal testing has outpaced clinical best practices as competing labs race to expand offerings and add options to screening tests to grab a piece of the global market, which is now about 130 million births per year.

“These are not scientifically sound additions and we need more evidence,” Stevens said. “There is a right way to handle this, and labs and clinicians need to collaborate on responsible methods to test and integrate expanding options.”
 

The blue and pink elephant in the room

“The reality is that most people don’t have a super high risk for chromosomal irregularities,” said Stevens. “Most people are more interested in learning the sex of their baby in early pregnancy than in any actual desire for genetic information.” Noninvasive prenatal testing can detect fetal sex as early as 9 weeks into a pregnancy, whereas ultrasound might not detect it until about 18 weeks.

“Honestly? I think the growing popularity of gender-reveal parties is what is actually driving the push for more prenatal testing,” she added. “The problem is that a couple eager to learn the sex of their baby may wind up with way more information than they expected and have trouble processing unanticipated risk.”

In February, five national medical organizations in the United States partnered with the Reproductive Genetics Technology Consortium to develop consensus recommendations and guidelines for prenatal genetic testing.

The National Society of Genetic Counselors and the Society for Maternal–Fetal Medicine are among the new members that will provide a forum through which commercial laboratories can communicate about new technologies and obtain input and guidance on emerging options.

Wapner, who is a member of the consortium, said he hopes thought leaders will be at the forefront to guide this next chapter of prenatal screening. “So much money is pouring into all this testing; let’s make sure we are making the right, most essential screening decisions,” he said.

“Science typically advances more rapidly than the ethical and legal framework to support decision-making, and it’s important for society to put protections in place,” Lo acknowledged.

The misuse of screening and unethical sex-selection efforts in Asia and elsewhere in the world, where males are highly valued and females are more likely to be aborted, is dismaying, he told Medscape Medical News. “These are exploitations of the science.”

In addition to scientific misuse like sex selection, data breaches are becoming a huge concern as companies amass large amounts of valuable genetic information.
 

Data for ransom

In Canada, where Crawley took her test, LifeLabs – the country’s largest laboratory testing company and a provider of genetic testing – paid a ransom after a major cyberattack led to the theft of lab results for 85,000 people in Ontario and the personal information of 15 million customers.

LifeLabs paid an undisclosed sum to retrieve the data, the company reported on December 17, and hired cybersecurity experts to assess the damage. The company is offering security protection services, including identity theft and fraud protection insurance, to customers.

“This has served as a reminder that we need to stay ahead of cybercrime, which has become a pervasive issue around the world in all sectors,” Charles Brown, president and chief executive officer of LifeLabs, wrote in a letter to customers. “You entrust us with important health information, and we take that responsibility very seriously.”

The United States has led the world in the commercial push for more prenatal testing. Other countries in Europe, for example, have proceeded with caution and have integrated the technologies with more controls. Hong Kong, where the inventor of the test is based, has been among the slowest to adopt the practice.

“I have been lobbying for 8 years for Hong Kong to offer testing,” said Lo. “I think Hong Kong has been too slow to integrate, but the United States probably moved too quickly. There is a balance that I think countries like the Netherlands have found; they take the aim of screening into account, along with justice and societal aspects.”

“Ideally, we will develop a great pretest model triage tool to help guide patients through this process,” Stevens said. “And we have to make sure the data they receive are clinically useful and backed up by evidence to safeguard the care of every patient.”

The practice of medicine is meticulously designed to assess and mitigate risk, “but this sensible objective can also be extremely negative in focus, with not-so-great delivery of information,” she acknowledged. Each individual’s tolerance for uncertainty and ability to cope in the face of adversity varies. “These are complex conversations that require time and empathy, and the details matter,” she added.

“In my home state of Texas, where there is a large religious base, there is not as much drive for advance prenatal genetic information,” Stevens explained. “We see a real advocacy movement emerging and a need for information from patients first because these can’t really be clinician-led decisions,” she pointed out. “Patients come to us undergoing not just the physical changes of pregnancy, but also emotional transformation as they transition to become parents. They may be nauseous or already sleep-deprived and they need our help,” she added.

Crawley could feel the fluttering of fetal movements in her womb and said she felt connected to her child, but she remembered her trip to Ireland when she and her husband drank too much and they likely conceived. Irrational thoughts crept in: “Maybe it was something we did. What about my swimming; could it have been harmful?”

Apprehensions lingered as she waited to meet her specialist. Would the child grow and be able to walk? Be held back by disabling joint pain? Crawley sat down with her doctor at the high-risk clinic to discuss the possibilities.

“I don’t see anything to be alarmed about. She’s probably going to be small,” said the obstetrician.

“She?!” Crawley had opted not to learn the sex of her baby, unlike so many other parents she knew, but her hope for her baby’s good health soared above the accidental disclosure.

“Everything changed in that moment,” Crawley said. “I knew that we were going to be okay no matter what happened next.”

Crawley’s pregnancy progressed to term and she gave birth to a healthy baby girl who is now 3 years old and dances ballet. Her beloved daughter is shorter than some of the other dancers in her class, but her mom says she hasn’t missed a beat. “The world is a better place because my daughter is in it,” Crawley said. “This, I know for sure.”

This article first appeared on Medscape.com.

When she was 4 months pregnant, Angela Crawley waited for 30 minutes in a private room to hear the results of her noninvasive prenatal testing. Her ultrasound had been flagged as high risk by the radiologist and she agreed to undergo further testing to gather information on the health of her unborn child.

As she waited for her genetic counseling appointment, she noticed somber expressions on the faces of her health team and picked up on hushed tones.

It had taken 2 years to become pregnant and the joy she felt attending prenatal care appointments was fading into a sense of dread as she sat in that small room and the minutes ticked by.

Crawley – a scientist in the chronic disease program at the Ottawa Hospital Research Institute, assistant professor at the University of Ottawa, and adjunct research professor at Carleton University in Ontario, Canada – is more qualified than most patients to absorb health information and make appropriate decisions.

And yet, “I was completely unprepared,” she told Medscape Medical News as she reflected on what she now refers to as some of the darkest days of her life. “It was a nightmare and it was such a confusing, scary time.”

Crawley is among the more than 6 million women from at least 90 countries who have undergone noninvasive prenatal testing. During pregnancy, a mother’s bloodstream contains a mix of cell-free DNA from her own cells and from placental cells, which is usually identical to the DNA of the fetus. Analysis of cell-free DNA can lead to the early detection of genetic disorders.

Testing is most often used to look for chromosomal disorders that are caused by the presence of an extra chromosome, like in trisomy 21 in the case of Down syndrome or extra or missing copies of the X and Y chromosomes in other disorders. The accuracy of the test tends to vary, depending on the condition being assessed.

Cell-free DNA testing has reduced the number of invasive prenatal diagnostic procedures, some of which can lead to miscarriage, and this noninvasive option made sense to Crawley and was covered by government health insurance.

With a market projected to surpass $13 billion by the year 2027, some experts speculate that prenatal genetic testing is the most rapidly adopted test in human history. Globally, noninvasive prenatal tests cost $500 to $3,000 for patients who pay out of pocket, and all those screening options are amassing valuable genetic data troves.

The pioneer of noninvasive prenatal testing, Dennis Lo, PhD, from the Chinese University of Hong Kong, told Medscape Medical News that the success of using cell-free DNA came after a long, winding road of rejected grant applications and scientific skepticism.

“Initially, people did not think this would be useful for assessing chromosomal abnormalities because the thinking at the time was that we would need to count them,” Lo said.

But he was enchanted by early glimpses of the capability of cell-free DNA, and felt driven to pursue unconventional research ideas even though there were significant hurdles to overcome in the lab.

“We were detecting fetal Y chromosomes in women. At first, it was just scientific curiosity,” said Lo. “At the time, people worried that fetal cells would persist from one pregnancy to the next, but we discovered that fetal DNA actually clears very quickly and does not progress into the next pregnancy,” he explained. “This is very important because it won’t alter the accuracy of the test.”

Gripped by the scientific mystery, the researcher put in long hours at the lab. “I’m fortunate I have a very understanding wife who is herself a scientist,” he said. After a particularly long stretch without quality time together, Lo and his spouse, Alice Wong, went to see a Harry Potter movie.

As Lo viewed the Harry Potter H through 3D glasses, he was suddenly reminded of the male human karyotype.

“I saw the vertical stripes of the H and it hit me,” he told Medscape Medical News. “There are two sets of chromosomes.” The average human karyotype contains 22 pairs of autosomal chromosomes and one pair of sex chromosomes.

“Our complex genetic conundrum was cracked in the middle of a Harry Potter movie in a moment when I felt completely relaxed,” he recalled. “My wife said: ‘You can’t even watch a movie properly.’ ”

Back at the lab, Lo shared his Harry Potter–inspired concept and the team got to work.

In December 2019, Lo received the Fudan-Zhongzhi Science Award in Shanghai from Nobel laureate physicist Samuel Chao Chung Ting, chair of the award committee. The prize honors fundamental and groundbreaking achievements in biomedicine, and the laureate receives ¥3 million (about U.S. $428,550), donated by Zhongzhi Enterprise Group.

This honor was 30 years in the making, Lo told Medscape Medical News. “I’m pleased to experience public recognition and this is a high honor in China,” he added.

“Noninvasive prenatal testing is better than anything we’ve ever had before,” said Ronald Wapner, MD, from the Columbia University Irving Medical Center in New York City, who taught a course on the transition of prenatal diagnostics from amniocentesis to whole-genome sequencing at the recent Society for Maternal–Fetal Medicine 2020 Annual Pregnancy Meeting.

“We now have the capability to improve healthcare decision-making in utero and at birth,” he told Medscape Medical News. “It’s remarkable.”

But, Wapner said, the market grew too fast. “The National Institutes of Health didn’t even play a role in these fast-paced developments. Traditional governing bodies and authorities were bypassed as cytogenetic labs marketed directly to physicians and patients,” he explained.

One of the major problems with the rapid uptake in testing is a lack of preparation for patients like Crawley.

The clinician who delivered her test results was not feeling well, so “she spoke through a surgical mask,” Crawley reported. “I was trying to understand what she was saying, but it was an uncomfortable exchange.”

Crawley had undergone prenatal genetic testing because her ultrasound had shown irregularities in fetal leg measurements. The genetic tests confirmed no anomalies in the chromosome count, but that was it.

“There was no prognosis, just vague numbers that no one seemed to know what to do with,” Crawley recalled.

With concern about growth measurements, the conversation moved quickly to options, including termination. Crawley said the dialogue felt jarring and moved too quickly for her to process all the information and possible courses of action.

She was told she could terminate and “try again to get pregnant.” But Crawley was 39 years old and had been trying to conceive for 2 years.

“It was devastating,” she said. “No one sat down with me before this appointment to learn about my values or preferences, and I left that conversation with more questions than I had before I arrived. I went home and had one the worst weekends of my life. My husband and I felt so overwhelmed, grieved, and alone.”

Pretest counseling can be as important as any subsequent genetic counseling, said Blair Stevens, a prenatal expert from the National Society of Genetic Counselors and a genetic counselor at the University of Texas Health Science Center in Houston.

“Information is valuable, but it can also be toxic, depending on what individuals intend to do with what they learn,” she explained. “We cannot unknow or unhear details, so it’s really important to work with patients in advance to make sure their preferences guide any planning.”

Uncertainty can be very unsettling, she acknowledged. “It’s important to help patients balance any ambiguity, so if there is a 20% risk, there is also an 80% chance of another, perhaps more favorable, outcome.”

Most clinicians don’t have the time to fully assess patient goals and align counseling approaches to individual needs, Stevens explained. And public interest in prenatal testing has outpaced clinical best practices as competing labs race to expand offerings and add options to screening tests to grab a piece of the global market, which is now about 130 million births per year.

“These are not scientifically sound additions and we need more evidence,” Stevens said. “There is a right way to handle this, and labs and clinicians need to collaborate on responsible methods to test and integrate expanding options.”
 

The blue and pink elephant in the room

“The reality is that most people don’t have a super high risk for chromosomal irregularities,” said Stevens. “Most people are more interested in learning the sex of their baby in early pregnancy than in any actual desire for genetic information.” Noninvasive prenatal testing can detect fetal sex as early as 9 weeks into a pregnancy, whereas ultrasound might not detect it until about 18 weeks.

“Honestly? I think the growing popularity of gender-reveal parties is what is actually driving the push for more prenatal testing,” she added. “The problem is that a couple eager to learn the sex of their baby may wind up with way more information than they expected and have trouble processing unanticipated risk.”

In February, five national medical organizations in the United States partnered with the Reproductive Genetics Technology Consortium to develop consensus recommendations and guidelines for prenatal genetic testing.

The National Society of Genetic Counselors and the Society for Maternal–Fetal Medicine are among the new members that will provide a forum through which commercial laboratories can communicate about new technologies and obtain input and guidance on emerging options.

Wapner, who is a member of the consortium, said he hopes thought leaders will be at the forefront to guide this next chapter of prenatal screening. “So much money is pouring into all this testing; let’s make sure we are making the right, most essential screening decisions,” he said.

“Science typically advances more rapidly than the ethical and legal framework to support decision-making, and it’s important for society to put protections in place,” Lo acknowledged.

The misuse of screening and unethical sex-selection efforts in Asia and elsewhere in the world, where males are highly valued and females are more likely to be aborted, is dismaying, he told Medscape Medical News. “These are exploitations of the science.”

In addition to scientific misuse like sex selection, data breaches are becoming a huge concern as companies amass large amounts of valuable genetic information.
 

Data for ransom

In Canada, where Crawley took her test, LifeLabs – the country’s largest laboratory testing company and a provider of genetic testing – paid a ransom after a major cyberattack led to the theft of lab results for 85,000 people in Ontario and the personal information of 15 million customers.

LifeLabs paid an undisclosed sum to retrieve the data, the company reported on December 17, and hired cybersecurity experts to assess the damage. The company is offering security protection services, including identity theft and fraud protection insurance, to customers.

“This has served as a reminder that we need to stay ahead of cybercrime, which has become a pervasive issue around the world in all sectors,” Charles Brown, president and chief executive officer of LifeLabs, wrote in a letter to customers. “You entrust us with important health information, and we take that responsibility very seriously.”

The United States has led the world in the commercial push for more prenatal testing. Other countries in Europe, for example, have proceeded with caution and have integrated the technologies with more controls. Hong Kong, where the inventor of the test is based, has been among the slowest to adopt the practice.

“I have been lobbying for 8 years for Hong Kong to offer testing,” said Lo. “I think Hong Kong has been too slow to integrate, but the United States probably moved too quickly. There is a balance that I think countries like the Netherlands have found; they take the aim of screening into account, along with justice and societal aspects.”

“Ideally, we will develop a great pretest model triage tool to help guide patients through this process,” Stevens said. “And we have to make sure the data they receive are clinically useful and backed up by evidence to safeguard the care of every patient.”

The practice of medicine is meticulously designed to assess and mitigate risk, “but this sensible objective can also be extremely negative in focus, with not-so-great delivery of information,” she acknowledged. Each individual’s tolerance for uncertainty and ability to cope in the face of adversity varies. “These are complex conversations that require time and empathy, and the details matter,” she added.

“In my home state of Texas, where there is a large religious base, there is not as much drive for advance prenatal genetic information,” Stevens explained. “We see a real advocacy movement emerging and a need for information from patients first because these can’t really be clinician-led decisions,” she pointed out. “Patients come to us undergoing not just the physical changes of pregnancy, but also emotional transformation as they transition to become parents. They may be nauseous or already sleep-deprived and they need our help,” she added.

Crawley could feel the fluttering of fetal movements in her womb and said she felt connected to her child, but she remembered her trip to Ireland when she and her husband drank too much and they likely conceived. Irrational thoughts crept in: “Maybe it was something we did. What about my swimming; could it have been harmful?”

Apprehensions lingered as she waited to meet her specialist. Would the child grow and be able to walk? Be held back by disabling joint pain? Crawley sat down with her doctor at the high-risk clinic to discuss the possibilities.

“I don’t see anything to be alarmed about. She’s probably going to be small,” said the obstetrician.

“She?!” Crawley had opted not to learn the sex of her baby, unlike so many other parents she knew, but her hope for her baby’s good health soared above the accidental disclosure.

“Everything changed in that moment,” Crawley said. “I knew that we were going to be okay no matter what happened next.”

Crawley’s pregnancy progressed to term and she gave birth to a healthy baby girl who is now 3 years old and dances ballet. Her beloved daughter is shorter than some of the other dancers in her class, but her mom says she hasn’t missed a beat. “The world is a better place because my daughter is in it,” Crawley said. “This, I know for sure.”

This article first appeared on Medscape.com.

Health care systems need to take urgent action to address social isolation and loneliness among U.S. seniors, experts say.

A new report from the National Academies of Sciences, Engineering, and Medicine (NAS) points out that social isolation in this population is a major public health concern that contributes to heart disease, depression, and premature death.

The report authors note that the health care system remains an underused partner in preventing, identifying, and intervening in social isolation and loneliness among adults over age 50.

For seniors who are homebound, have no family, or do not belong to community or faith groups, a medical appointment or home health visit may be one of the few social interactions they have, the report notes.

Health care providers and systems may be “first responders” in recognizing lonely or socially isolated patients, committee chair Dan Blazer, MD, from Duke University School of Medicine, Durham, N.C., said during a press briefing.
 

As deadly as obesity, smoking

Committee member Julianne Holt-Lunstad, PhD, from Brigham Young University, Provo, Utah, noted that social isolation and loneliness are “distinctly different.”

Social isolation is defined as an objective lack of (or limited) social connections, while loneliness is a subjective perception of social isolation or the subjective feeling of being lonely.

Not all older adults are isolated or lonely, but they are more likely to face predisposing factors such as living alone and the loss of loved ones, she explained.

The issue may be compounded for LGBT, minority, and immigrant older adults, who may already face barriers to care, stigma, and discrimination. Social isolation and loneliness may also directly stem from chronic illness, hearing or vision loss, or mobility issues. In these cases, health care providers might be able to help prevent or reduce social isolation and loneliness by directly addressing the underlying health-related causes.

Some evidence suggests that the magnitude of the effect of social isolation on premature mortality may be comparable to or greater than smoking, obesity, and physical inactivity, Holt-Lunstad told the briefing. The report offers a vision for how the health care system can identify people at risk of social isolation and loneliness, intervene, and engage other community partners.

It recommends that providers use validated tools to periodically assess patients who may be at risk for social isolation and loneliness and connect them to community resources for help.

The report also calls for greater education and training among health providers. Schools of health professions and training programs for direct care workers (eg, home health aides, nurse aides, and personal care aides) should incorporate social isolation and loneliness in their curricula, the report says.

It also offers recommendations for leveraging digital health and health technology, improving community partnerships, increasing funding for research, and creation of a national resource center under the Department of Health and Human Services.

Blazer said there remains “much to be learned” about what approaches to mitigating social isolation and loneliness work best in which populations.

The report, from the Committee on the Health and Medical Dimensions of Social Isolation and Loneliness in Older Adults, was sponsored by the AARP Foundation.

This article first appeared on Medscape.com.

Health care systems need to take urgent action to address social isolation and loneliness among U.S. seniors, experts say.

A new report from the National Academies of Sciences, Engineering, and Medicine (NAS) points out that social isolation in this population is a major public health concern that contributes to heart disease, depression, and premature death.

The report authors note that the health care system remains an underused partner in preventing, identifying, and intervening in social isolation and loneliness among adults over age 50.

For seniors who are homebound, have no family, or do not belong to community or faith groups, a medical appointment or home health visit may be one of the few social interactions they have, the report notes.

Health care providers and systems may be “first responders” in recognizing lonely or socially isolated patients, committee chair Dan Blazer, MD, from Duke University School of Medicine, Durham, N.C., said during a press briefing.
 

As deadly as obesity, smoking

Committee member Julianne Holt-Lunstad, PhD, from Brigham Young University, Provo, Utah, noted that social isolation and loneliness are “distinctly different.”

Social isolation is defined as an objective lack of (or limited) social connections, while loneliness is a subjective perception of social isolation or the subjective feeling of being lonely.

Not all older adults are isolated or lonely, but they are more likely to face predisposing factors such as living alone and the loss of loved ones, she explained.

The issue may be compounded for LGBT, minority, and immigrant older adults, who may already face barriers to care, stigma, and discrimination. Social isolation and loneliness may also directly stem from chronic illness, hearing or vision loss, or mobility issues. In these cases, health care providers might be able to help prevent or reduce social isolation and loneliness by directly addressing the underlying health-related causes.

Some evidence suggests that the magnitude of the effect of social isolation on premature mortality may be comparable to or greater than smoking, obesity, and physical inactivity, Holt-Lunstad told the briefing. The report offers a vision for how the health care system can identify people at risk of social isolation and loneliness, intervene, and engage other community partners.

It recommends that providers use validated tools to periodically assess patients who may be at risk for social isolation and loneliness and connect them to community resources for help.

The report also calls for greater education and training among health providers. Schools of health professions and training programs for direct care workers (eg, home health aides, nurse aides, and personal care aides) should incorporate social isolation and loneliness in their curricula, the report says.

It also offers recommendations for leveraging digital health and health technology, improving community partnerships, increasing funding for research, and creation of a national resource center under the Department of Health and Human Services.

Blazer said there remains “much to be learned” about what approaches to mitigating social isolation and loneliness work best in which populations.

The report, from the Committee on the Health and Medical Dimensions of Social Isolation and Loneliness in Older Adults, was sponsored by the AARP Foundation.

This article first appeared on Medscape.com.

Health care systems need to take urgent action to address social isolation and loneliness among U.S. seniors, experts say.

A new report from the National Academies of Sciences, Engineering, and Medicine (NAS) points out that social isolation in this population is a major public health concern that contributes to heart disease, depression, and premature death.

The report authors note that the health care system remains an underused partner in preventing, identifying, and intervening in social isolation and loneliness among adults over age 50.

For seniors who are homebound, have no family, or do not belong to community or faith groups, a medical appointment or home health visit may be one of the few social interactions they have, the report notes.

Health care providers and systems may be “first responders” in recognizing lonely or socially isolated patients, committee chair Dan Blazer, MD, from Duke University School of Medicine, Durham, N.C., said during a press briefing.
 

As deadly as obesity, smoking

Committee member Julianne Holt-Lunstad, PhD, from Brigham Young University, Provo, Utah, noted that social isolation and loneliness are “distinctly different.”

Social isolation is defined as an objective lack of (or limited) social connections, while loneliness is a subjective perception of social isolation or the subjective feeling of being lonely.

Not all older adults are isolated or lonely, but they are more likely to face predisposing factors such as living alone and the loss of loved ones, she explained.

The issue may be compounded for LGBT, minority, and immigrant older adults, who may already face barriers to care, stigma, and discrimination. Social isolation and loneliness may also directly stem from chronic illness, hearing or vision loss, or mobility issues. In these cases, health care providers might be able to help prevent or reduce social isolation and loneliness by directly addressing the underlying health-related causes.

Some evidence suggests that the magnitude of the effect of social isolation on premature mortality may be comparable to or greater than smoking, obesity, and physical inactivity, Holt-Lunstad told the briefing. The report offers a vision for how the health care system can identify people at risk of social isolation and loneliness, intervene, and engage other community partners.

It recommends that providers use validated tools to periodically assess patients who may be at risk for social isolation and loneliness and connect them to community resources for help.

The report also calls for greater education and training among health providers. Schools of health professions and training programs for direct care workers (eg, home health aides, nurse aides, and personal care aides) should incorporate social isolation and loneliness in their curricula, the report says.

It also offers recommendations for leveraging digital health and health technology, improving community partnerships, increasing funding for research, and creation of a national resource center under the Department of Health and Human Services.

Blazer said there remains “much to be learned” about what approaches to mitigating social isolation and loneliness work best in which populations.

The report, from the Committee on the Health and Medical Dimensions of Social Isolation and Loneliness in Older Adults, was sponsored by the AARP Foundation.

This article first appeared on Medscape.com.

When physicians gaze into their crystal balls to predict what’s coming in 2020, they see continued efforts to defund the Affordable Care Act – meaning the ACA will still be around to be defunded – but they don’t see a lot of support for universal health care, according to health care market research company InCrowd.

Expectations for universal health care came in at 18% of the 100 generalists and 101 specialists who responded to InCrowd’s fifth annual health care predictions survey, which left 82% who thought that “election outcomes will result in universal healthcare support” was somewhat or very unlikely in 2020.

One respondent, a specialist from California, commented that “the global data on universal healthcare for all shows that it results in overall improved population health. Unfortunately, we are so polarized in the US against universal healthcare driven by bias from health insurance companies and decision makers that are quick to ignore scientific data.”

This was the first time InCrowd asked physicians about universal health care, but ACA-related predictions have been included before, and all three scenarios presented were deemed to be increasingly likely, compared with 2019.

Respondents thought that federal government defunding was more likely to occur in 2020 (80%) than in 2019 (73%), but increased majorities also said that preexisting conditions coverage would continue (78% in 2020 vs. 70% in 2019) and that the ACA would remain in place (74% in 2020 vs. 60% in 2019), InCrowd reported after the survey, which was conducted from Dec. 30, 2019, to Jan. 2, 2020.

A respondent who thought the ACA will be eliminated said, “I have as many uninsured today as before the ACA. They are just different. Mainly younger patients who spend less in a year on healthcare than one month’s premium.” Another suggested that eliminateing it “will limit access to care and overload [emergency departments]. More people will die.”

Cost was addressed in a separate survey question that asked how physicians could help to reduce health care spending in 2020.

The leading answer, given by 37% of respondents, was for physicians to “inform themselves of costs and adapt cost-saving prescription practices.” Next came “limit use of expensive tests and scans” with 21%, followed by “prescribe generics when possible” at 20%, which was a substantial drop from the 38% it garnered in 2019, InCrowd noted.

“Participation in [shared savings] programs and risk-based incentive programs and pay-for-performance programs” would provide “better stewardship of resources,” a primary care physician from Michigan wrote.

When the survey turned to pharmaceutical industry predictions for 2020, cost was the major issue.

“What’s interesting about this year’s data is that we’re seeing less emphasis on the importance of bringing innovative, new therapies to market faster … versus expanding affordability, which was nearly a unanimous top priority for respondents,” Daniel S. Fitzgerald, InCrowd’s CEO and president, said in a separate statement.

rfranki@mdedge.com

When physicians gaze into their crystal balls to predict what’s coming in 2020, they see continued efforts to defund the Affordable Care Act – meaning the ACA will still be around to be defunded – but they don’t see a lot of support for universal health care, according to health care market research company InCrowd.

Expectations for universal health care came in at 18% of the 100 generalists and 101 specialists who responded to InCrowd’s fifth annual health care predictions survey, which left 82% who thought that “election outcomes will result in universal healthcare support” was somewhat or very unlikely in 2020.

One respondent, a specialist from California, commented that “the global data on universal healthcare for all shows that it results in overall improved population health. Unfortunately, we are so polarized in the US against universal healthcare driven by bias from health insurance companies and decision makers that are quick to ignore scientific data.”

This was the first time InCrowd asked physicians about universal health care, but ACA-related predictions have been included before, and all three scenarios presented were deemed to be increasingly likely, compared with 2019.

Respondents thought that federal government defunding was more likely to occur in 2020 (80%) than in 2019 (73%), but increased majorities also said that preexisting conditions coverage would continue (78% in 2020 vs. 70% in 2019) and that the ACA would remain in place (74% in 2020 vs. 60% in 2019), InCrowd reported after the survey, which was conducted from Dec. 30, 2019, to Jan. 2, 2020.

A respondent who thought the ACA will be eliminated said, “I have as many uninsured today as before the ACA. They are just different. Mainly younger patients who spend less in a year on healthcare than one month’s premium.” Another suggested that eliminateing it “will limit access to care and overload [emergency departments]. More people will die.”

Cost was addressed in a separate survey question that asked how physicians could help to reduce health care spending in 2020.

The leading answer, given by 37% of respondents, was for physicians to “inform themselves of costs and adapt cost-saving prescription practices.” Next came “limit use of expensive tests and scans” with 21%, followed by “prescribe generics when possible” at 20%, which was a substantial drop from the 38% it garnered in 2019, InCrowd noted.

“Participation in [shared savings] programs and risk-based incentive programs and pay-for-performance programs” would provide “better stewardship of resources,” a primary care physician from Michigan wrote.

When the survey turned to pharmaceutical industry predictions for 2020, cost was the major issue.

“What’s interesting about this year’s data is that we’re seeing less emphasis on the importance of bringing innovative, new therapies to market faster … versus expanding affordability, which was nearly a unanimous top priority for respondents,” Daniel S. Fitzgerald, InCrowd’s CEO and president, said in a separate statement.

rfranki@mdedge.com

When physicians gaze into their crystal balls to predict what’s coming in 2020, they see continued efforts to defund the Affordable Care Act – meaning the ACA will still be around to be defunded – but they don’t see a lot of support for universal health care, according to health care market research company InCrowd.

Expectations for universal health care came in at 18% of the 100 generalists and 101 specialists who responded to InCrowd’s fifth annual health care predictions survey, which left 82% who thought that “election outcomes will result in universal healthcare support” was somewhat or very unlikely in 2020.

One respondent, a specialist from California, commented that “the global data on universal healthcare for all shows that it results in overall improved population health. Unfortunately, we are so polarized in the US against universal healthcare driven by bias from health insurance companies and decision makers that are quick to ignore scientific data.”

This was the first time InCrowd asked physicians about universal health care, but ACA-related predictions have been included before, and all three scenarios presented were deemed to be increasingly likely, compared with 2019.

Respondents thought that federal government defunding was more likely to occur in 2020 (80%) than in 2019 (73%), but increased majorities also said that preexisting conditions coverage would continue (78% in 2020 vs. 70% in 2019) and that the ACA would remain in place (74% in 2020 vs. 60% in 2019), InCrowd reported after the survey, which was conducted from Dec. 30, 2019, to Jan. 2, 2020.

A respondent who thought the ACA will be eliminated said, “I have as many uninsured today as before the ACA. They are just different. Mainly younger patients who spend less in a year on healthcare than one month’s premium.” Another suggested that eliminateing it “will limit access to care and overload [emergency departments]. More people will die.”

Cost was addressed in a separate survey question that asked how physicians could help to reduce health care spending in 2020.

The leading answer, given by 37% of respondents, was for physicians to “inform themselves of costs and adapt cost-saving prescription practices.” Next came “limit use of expensive tests and scans” with 21%, followed by “prescribe generics when possible” at 20%, which was a substantial drop from the 38% it garnered in 2019, InCrowd noted.

“Participation in [shared savings] programs and risk-based incentive programs and pay-for-performance programs” would provide “better stewardship of resources,” a primary care physician from Michigan wrote.

When the survey turned to pharmaceutical industry predictions for 2020, cost was the major issue.

“What’s interesting about this year’s data is that we’re seeing less emphasis on the importance of bringing innovative, new therapies to market faster … versus expanding affordability, which was nearly a unanimous top priority for respondents,” Daniel S. Fitzgerald, InCrowd’s CEO and president, said in a separate statement.

rfranki@mdedge.com

The U.S. Supreme Court has agreed to hear Texas v. California, a closely watched case that could upend the Affordable Care Act.

ETIENJones/thinkstockphotos

The justices will hear oral arguments in the case in fall 2020, with a ruling likely in 2021.

The Texas case, consolidated with a similar challenge, stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Since the Trump administration declined to defend the ACA, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. On March 2, the U.S. Supreme Court granted two petitions by the defendants requesting that the high court review the appeals court decision.

The review follows a previous look at the ACA’s mandate by the Supreme Court in 2012. In National Federation of Independent Business v. Sebelius, justices upheld the ACA’s insurance mandate as constitutional, ruling the requirement was authorized by Congress’ power to levy taxes. The vote was 5-4, with Chief Justice John G. Roberts Jr. in agreement with the court’s four more liberal members.

agallegos@mdedge.com

The U.S. Supreme Court has agreed to hear Texas v. California, a closely watched case that could upend the Affordable Care Act.

ETIENJones/thinkstockphotos

The justices will hear oral arguments in the case in fall 2020, with a ruling likely in 2021.

The Texas case, consolidated with a similar challenge, stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Since the Trump administration declined to defend the ACA, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. On March 2, the U.S. Supreme Court granted two petitions by the defendants requesting that the high court review the appeals court decision.

The review follows a previous look at the ACA’s mandate by the Supreme Court in 2012. In National Federation of Independent Business v. Sebelius, justices upheld the ACA’s insurance mandate as constitutional, ruling the requirement was authorized by Congress’ power to levy taxes. The vote was 5-4, with Chief Justice John G. Roberts Jr. in agreement with the court’s four more liberal members.

agallegos@mdedge.com

The U.S. Supreme Court has agreed to hear Texas v. California, a closely watched case that could upend the Affordable Care Act.

ETIENJones/thinkstockphotos

The justices will hear oral arguments in the case in fall 2020, with a ruling likely in 2021.

The Texas case, consolidated with a similar challenge, stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Since the Trump administration declined to defend the ACA, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. On March 2, the U.S. Supreme Court granted two petitions by the defendants requesting that the high court review the appeals court decision.

The review follows a previous look at the ACA’s mandate by the Supreme Court in 2012. In National Federation of Independent Business v. Sebelius, justices upheld the ACA’s insurance mandate as constitutional, ruling the requirement was authorized by Congress’ power to levy taxes. The vote was 5-4, with Chief Justice John G. Roberts Jr. in agreement with the court’s four more liberal members.

agallegos@mdedge.com

Many US endocrinologists are crying foul as a growing number of state lawmakers are attempting to enact legislation that would prohibit, and in some cases criminalize, medical treatment for minors with gender dysphoria.

As of press time, 13 states had introduced such bills, and legislators in two additional states said they were drafting bills. So far, one — in South Dakota — was defeated in a Senate committee, and another, in Florida, was essentially tabled without being enacted.

They all have a common goal of preventing minors from receiving puberty blockers, cross-sex hormones, or gender-affirmation surgery.

“These things are being proposed based on a lot of misinformation,” said Stephen Rosenthal, MD, professor of pediatrics at the University of California, San Francisco (UCSF), and a past president of the Pediatric Endocrine Society.

Lawmakers “are not looking at the scientific evidence that supports current clinical practice guidelines,” Rosenthal, who treats transgender children, told Medscape Medical News.

And “People just aren’t really understanding the harm that regulating this kind of medicine would do,” stressed Cassandra Brady, MD, assistant professor of pediatric endocrinology at Vanderbilt University School of Medicine, Memphis, Tennessee.

The bills come at a time when gender identity clinics for minors around the world have seen a significant uptick in cases. And, as widely reported by Medscape Medical News, some clinicians have begun to question whether treatment decisions are outpacing science.

Queries about use of puberty blockers and cross-sex hormones have embroiled the United Kingdom’s only publicly funded Gender Identity Development Service (GIDS) in controversy, for example, with five clinicians resigning last year over concerns about overuse of the treatments.

And earlier this month, the UK National Health Service (NHS) announced an independent review of services including the use of puberty blockers and cross-sex hormones in youth with gender dysphoria.

Meanwhile, the topic has ignited debate in Sweden, where a report from the Board of Health and Welfare confirmed a 1,500% rise between 2008 and 2018 in gender dysphoria diagnoses among 13- to 17-year-olds born as girls, as detailed by The Guardian.

Indeed, there is some indication of a so-called “rapid-onset gender dysphoria” in born females who say they wish to become males and some clinicians have said this represents a “social” phenomenon.

But guidelines from US clinical organizations – including the American Academy of Pediatrics issued in 2018, the Endocrine Society as reported by Medscape Medical News in 2017, and the US Professional Association for Transgender Health (USPATH) – all support the use of medical treatment in adolescents with gender dysphoria who have received mental health evaluations from appropriately trained professionals.

More data needed but evidence to intervene is compelling

Joshua Safer, MD, FACP, FACE, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York City, says the data “even if it’s rudimentary, are convincing that there is a biological component to gender identity.”

Attempts to manipulate gender identity in people who are born intersex, for example, have uniformly failed, he noted.

Yet it’s still not known what causes gender identity – whether it might be a result of a cluster of genes or a bundle in the brain, or some other biological process – said Safer, who treats transgender adults, but not children, and is also a coauthor of the aforementioned Endocrine Society Clinical Practice Guideline on Endocrine Treatment of Gender Dysphoric/Gender Incongruent Persons.

This is an area for future research, he noted.

Nevertheless, “The data for interventions for transgender people ... is compelling,” he added, noting evidence for improved mental health morbidity among those gender-questioning people who have medical interventions.

“Those data are modest at this point and we need better data, but they do all move in the same direction,” he asserted.

Meanwhile, a large group of around 1,800 parents of transgender and nonbinary children have called on legislators to withdraw the proposals in an open letter organized by the Human Rights Campaign.

“We know better than anyone what our children need in order to thrive: access to best practice, evidence-based gender-affirming healthcare,” the parents write.

“These healthcare decisions must be made on a case-by-case basis, in careful consultation with a medical team, and with the goal of reducing the physical and emotional distress experienced by many transgender children,” they continue.

“They should not be made by politicians who think they know better than medical professionals,” they add.

The American Academy of Child and Adolescent Psychiatry has also condemned state efforts “to block access to these recognized interventions,” it said in a statement.

Proponents of laws speak of harms

Most of the state proposals portray medical interventions as harmful to minors.

Missouri’s proposed legislation labels surgical or hormonal treatment for a child under age 18 “abuse or neglect”; a physician or anyone who assists or provides for the child would be charged with a felony.

One of the first bills was introduced in South Dakota in January. House bill 1057 would have charged clinicians providing gender-affirming care in anyone under age 16 with a misdemeanor punishable by up to a year in prison and a $2,000 fine.

The bill was defeated in the Senate after the South Dakota State Medical Association and several other physicians, families, and adolescents testified against the proposal, according to the Argus Leader.

The Endocrine Society applauded the failure and noted in a statement that it “supports physicians’ ability to provide the best evidence-based treatment to their patients,” and that “these decisions should be made by the family and physician, and not dictated by policymakers.”

Jack Turban, MD, a resident physician in child and adolescent psychiatry at Massachusetts General Hospital, Boston, who conducted a pivotal study of some 26,000 transgender adults showing that early administration of puberty blockers led to lower odds of lifetime suicidal ideation, also expressed dismay over the bills in an opinion piece for the New York Times.

“The potential benefits of providing gender-affirmative care typically outweigh the minor risks associated with treatment,” wrote Turban.

“State legislators need to educate themselves about these young people and their medical care before introducing legislation that will hurt them,” he added.
 

Few states seem to have approached clinicians for feedback

In Tennessee, lawmakers have approached some clinicians at Vanderbilt and have appreciated the feedback they’ve received so far, said Brady.

But that may be an exception. It seems that few medical organizations have been consulted in the crafting of bills in the other states: Colorado, Florida, Idaho, Illinois, Kentucky, Mississippi, Missouri, New Hampshire, Oklahoma, South Carolina, South Dakota, and West Virginia. Lawmakers in Ohio and Utah also are drafting proposals.

Physicians could be charged with a felony in Florida, Idaho, Kentucky, Missouri, and reportedly, in the Ohio proposal under development.

The bills have been introduced at the behest of some conservative groups that doubt the existence of gender dysphoria or who have questions about treatment: the Eagle Forum, the Alliance Defending Freedom, and the Kelsey Coalition.

In a recent tweet clarifying its position on state efforts, the Kelsey Coalition said it “supports all bills that protect children, even those that may provide criminal penalties, because we believe these medical interventions should never be performed on children.”

“However, we do not support state bills that are not victim-led or used for political gain,” they added.
 

Existing knowledge imperfect but treatment indicated for some

The bills have also garnered support from some endocrinologists who have raised concerns about puberty blockers and other medical treatments for gender dysphoria.

One is Michael K. Laidlaw, MD, a Rocklin, California–based endocrinologist who has not treated transgender people but frequently writes about the subject, most recently calling the use of puberty blockers “a public health emergency.”

Laidlaw joined several other clinicians who do not treat transgender people in testifying in favor of the South Dakota bill.

Last year, as previously reported by Medscape Medical News, Laidlaw, along with others, criticized the Endocrine Society’s 2017 Clinical Practice Guideline on Treating Dysphoric/Gender-Incongruent Persons in a letter to the Journal of Clinical Endocrinology & Metabolism.

They stated that there is no lab, imaging, or other objective test to diagnose someone as transgender and that “the consequences of this gender-affirmative therapy are not trivial and include potential sterility, sexual dysfunction, thromboembolic and cardiovascular disease, and malignancy.”

Laidlaw told Medscape Medical News at the time that “If we’re talking about [transgender] adults [who have gone through puberty of their biological sex] and who can make a decision, if they have been truly notified of the risks and benefits [of cross-sex hormones] and have also had psychological evaluation, and they decide, ‘This is still the right course for me,’ then I don’t have any objection.”

But considering the use of cross-sex hormones in children and adolescents is “quite a different story,” he contended.

In May 2019, Rosenthal, Safer and colleagues responded to Laidlaw’s letter in the same journal, stating that for the right person, puberty blockers and cross-sex hormones are appropriate, and that medications can improve mental health outcomes.

“We agree that research to validate the safety and efficacy of all forms of treatment is desirable,” they wrote, noting some of that research is underway.

“However, we believe physicians would fall short in their duty of care if they withheld hormonal treatment of gender dysphoria/incongruence in pubertal youth, when indicated, given the existing state of knowledge, imperfect though it is.”
 

Research to validate safety and efficacy of transgender TX underway

Rosenthal’s center at UCSF is one of four in the United States that has been carrying out a National Institutes of Health-funded long-term observational study of the impact of early medical intervention on transgender adolescents.

It will take time to get those results, but in the meantime, clinicians should act on what is known now, said Rosenthal.

“We already have very compelling data to suggest that the benefits [of treatment] outweigh the potential harms,” he said.

Rosenthal told Medscape Medical News that Laidlaw has advanced the notion that clinicians who prescribe puberty blockers are forcing those individuals into a transgender outcome.

“We don’t push anybody down any path,” he said. “The guidelines make these treatments available in a very specific subset of people who are evaluated by skilled mental health professionals,” said Rosenthal.

Both he and Safer acknowledge that puberty blockers do have the potential for some harm. For instance, a frank discussion needs to happen about the likely lack of future fertility, said Rosenthal.

“Everything we do in medicine has a theoretical risk of harm,” noted Safer.

However, he said, to deny a puberty blocker to an individual approaching puberty who is distraught about growing breasts — but then to possibly have to surgically remove them later — is in itself doing harm.

“Puberty blockers are exactly the epitome of ‘do no harm’ in this case,” argued Safer.

The medications are reversible, he said, adding that they also give an individual and the family time to think through whether the adolescent is transgender, and, if yes, what they want to do in terms of taking cross-sex hormones in the future or getting other interventions.

Safer acknowledged that this doesn’t mean there aren’t still some concerns, however.

For instance, once puberty blockers — which have the potential to interfere with bone development — are started, “How much harm are you willing to risk? Maybe a couple of years is okay, but maybe 6 years is not,” he said.

“So, we do discuss how quickly...you have to get to your next decision point, whether it be to actually introduce hormones or not to introduce hormones,” he explained.
 

State proposals will have chilling effect on gender-questioning kids

Clinicians say that even if the proposals do not become law, just the fact of their existence could have a chilling effect on gender-questioning children, their families, and doctors considering whether to provide treatment.

“They’re already in a hard position,” Brady said of her patients.

“They’re coming here to seek something for a life that they’ve already not wanted to live and then we have people who are trying to put a real big block on that – I see that obviously affecting their mental health,” she observed.

“I can’t imagine how their lives would be without this care,” Brady said.

With the bills being out there, “two things can happen – one is, it can be very depressing and limiting, but it can also embolden people,” Rosenthal told Medscape Medical News.

“The people behind these things are the same people that have tried to stop our research at the National Institutes of Health (NIH),” he explained.

“These people are going to do everything they can, whether it’s to go state by state to try and exhaust us, or go to the NIH and try to get them to pull the plug on our research,” said Rosenthal.

Safer believes it’s ill-considered to try to legislate any aspect of medicine.

“The pitfalls of trying to legislate these things are myriad,” he said.

“Across all of medicine, interventions are very customized. Can you imagine a state legislature trying to legislate the optimal approach in medicines that can and cannot be given to people with diabetes? How crazy that would be,” he noted.

Rosenthal has served on an advisory panel for Endo Pharmaceuticals and is a grantee of the NIH. Safer has also served on an advisory panel for Endo Pharmaceuticals. Brady has reported no relevant financial relationships.

This article first appeared on Medscape.com.

Many US endocrinologists are crying foul as a growing number of state lawmakers are attempting to enact legislation that would prohibit, and in some cases criminalize, medical treatment for minors with gender dysphoria.

As of press time, 13 states had introduced such bills, and legislators in two additional states said they were drafting bills. So far, one — in South Dakota — was defeated in a Senate committee, and another, in Florida, was essentially tabled without being enacted.

They all have a common goal of preventing minors from receiving puberty blockers, cross-sex hormones, or gender-affirmation surgery.

“These things are being proposed based on a lot of misinformation,” said Stephen Rosenthal, MD, professor of pediatrics at the University of California, San Francisco (UCSF), and a past president of the Pediatric Endocrine Society.

Lawmakers “are not looking at the scientific evidence that supports current clinical practice guidelines,” Rosenthal, who treats transgender children, told Medscape Medical News.

And “People just aren’t really understanding the harm that regulating this kind of medicine would do,” stressed Cassandra Brady, MD, assistant professor of pediatric endocrinology at Vanderbilt University School of Medicine, Memphis, Tennessee.

The bills come at a time when gender identity clinics for minors around the world have seen a significant uptick in cases. And, as widely reported by Medscape Medical News, some clinicians have begun to question whether treatment decisions are outpacing science.

Queries about use of puberty blockers and cross-sex hormones have embroiled the United Kingdom’s only publicly funded Gender Identity Development Service (GIDS) in controversy, for example, with five clinicians resigning last year over concerns about overuse of the treatments.

And earlier this month, the UK National Health Service (NHS) announced an independent review of services including the use of puberty blockers and cross-sex hormones in youth with gender dysphoria.

Meanwhile, the topic has ignited debate in Sweden, where a report from the Board of Health and Welfare confirmed a 1,500% rise between 2008 and 2018 in gender dysphoria diagnoses among 13- to 17-year-olds born as girls, as detailed by The Guardian.

Indeed, there is some indication of a so-called “rapid-onset gender dysphoria” in born females who say they wish to become males and some clinicians have said this represents a “social” phenomenon.

But guidelines from US clinical organizations – including the American Academy of Pediatrics issued in 2018, the Endocrine Society as reported by Medscape Medical News in 2017, and the US Professional Association for Transgender Health (USPATH) – all support the use of medical treatment in adolescents with gender dysphoria who have received mental health evaluations from appropriately trained professionals.

More data needed but evidence to intervene is compelling

Joshua Safer, MD, FACP, FACE, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York City, says the data “even if it’s rudimentary, are convincing that there is a biological component to gender identity.”

Attempts to manipulate gender identity in people who are born intersex, for example, have uniformly failed, he noted.

Yet it’s still not known what causes gender identity – whether it might be a result of a cluster of genes or a bundle in the brain, or some other biological process – said Safer, who treats transgender adults, but not children, and is also a coauthor of the aforementioned Endocrine Society Clinical Practice Guideline on Endocrine Treatment of Gender Dysphoric/Gender Incongruent Persons.

This is an area for future research, he noted.

Nevertheless, “The data for interventions for transgender people ... is compelling,” he added, noting evidence for improved mental health morbidity among those gender-questioning people who have medical interventions.

“Those data are modest at this point and we need better data, but they do all move in the same direction,” he asserted.

Meanwhile, a large group of around 1,800 parents of transgender and nonbinary children have called on legislators to withdraw the proposals in an open letter organized by the Human Rights Campaign.

“We know better than anyone what our children need in order to thrive: access to best practice, evidence-based gender-affirming healthcare,” the parents write.

“These healthcare decisions must be made on a case-by-case basis, in careful consultation with a medical team, and with the goal of reducing the physical and emotional distress experienced by many transgender children,” they continue.

“They should not be made by politicians who think they know better than medical professionals,” they add.

The American Academy of Child and Adolescent Psychiatry has also condemned state efforts “to block access to these recognized interventions,” it said in a statement.

Proponents of laws speak of harms

Most of the state proposals portray medical interventions as harmful to minors.

Missouri’s proposed legislation labels surgical or hormonal treatment for a child under age 18 “abuse or neglect”; a physician or anyone who assists or provides for the child would be charged with a felony.

One of the first bills was introduced in South Dakota in January. House bill 1057 would have charged clinicians providing gender-affirming care in anyone under age 16 with a misdemeanor punishable by up to a year in prison and a $2,000 fine.

The bill was defeated in the Senate after the South Dakota State Medical Association and several other physicians, families, and adolescents testified against the proposal, according to the Argus Leader.

The Endocrine Society applauded the failure and noted in a statement that it “supports physicians’ ability to provide the best evidence-based treatment to their patients,” and that “these decisions should be made by the family and physician, and not dictated by policymakers.”

Jack Turban, MD, a resident physician in child and adolescent psychiatry at Massachusetts General Hospital, Boston, who conducted a pivotal study of some 26,000 transgender adults showing that early administration of puberty blockers led to lower odds of lifetime suicidal ideation, also expressed dismay over the bills in an opinion piece for the New York Times.

“The potential benefits of providing gender-affirmative care typically outweigh the minor risks associated with treatment,” wrote Turban.

“State legislators need to educate themselves about these young people and their medical care before introducing legislation that will hurt them,” he added.
 

Few states seem to have approached clinicians for feedback

In Tennessee, lawmakers have approached some clinicians at Vanderbilt and have appreciated the feedback they’ve received so far, said Brady.

But that may be an exception. It seems that few medical organizations have been consulted in the crafting of bills in the other states: Colorado, Florida, Idaho, Illinois, Kentucky, Mississippi, Missouri, New Hampshire, Oklahoma, South Carolina, South Dakota, and West Virginia. Lawmakers in Ohio and Utah also are drafting proposals.

Physicians could be charged with a felony in Florida, Idaho, Kentucky, Missouri, and reportedly, in the Ohio proposal under development.

The bills have been introduced at the behest of some conservative groups that doubt the existence of gender dysphoria or who have questions about treatment: the Eagle Forum, the Alliance Defending Freedom, and the Kelsey Coalition.

In a recent tweet clarifying its position on state efforts, the Kelsey Coalition said it “supports all bills that protect children, even those that may provide criminal penalties, because we believe these medical interventions should never be performed on children.”

“However, we do not support state bills that are not victim-led or used for political gain,” they added.
 

Existing knowledge imperfect but treatment indicated for some

The bills have also garnered support from some endocrinologists who have raised concerns about puberty blockers and other medical treatments for gender dysphoria.

One is Michael K. Laidlaw, MD, a Rocklin, California–based endocrinologist who has not treated transgender people but frequently writes about the subject, most recently calling the use of puberty blockers “a public health emergency.”

Laidlaw joined several other clinicians who do not treat transgender people in testifying in favor of the South Dakota bill.

Last year, as previously reported by Medscape Medical News, Laidlaw, along with others, criticized the Endocrine Society’s 2017 Clinical Practice Guideline on Treating Dysphoric/Gender-Incongruent Persons in a letter to the Journal of Clinical Endocrinology & Metabolism.

They stated that there is no lab, imaging, or other objective test to diagnose someone as transgender and that “the consequences of this gender-affirmative therapy are not trivial and include potential sterility, sexual dysfunction, thromboembolic and cardiovascular disease, and malignancy.”

Laidlaw told Medscape Medical News at the time that “If we’re talking about [transgender] adults [who have gone through puberty of their biological sex] and who can make a decision, if they have been truly notified of the risks and benefits [of cross-sex hormones] and have also had psychological evaluation, and they decide, ‘This is still the right course for me,’ then I don’t have any objection.”

But considering the use of cross-sex hormones in children and adolescents is “quite a different story,” he contended.

In May 2019, Rosenthal, Safer and colleagues responded to Laidlaw’s letter in the same journal, stating that for the right person, puberty blockers and cross-sex hormones are appropriate, and that medications can improve mental health outcomes.

“We agree that research to validate the safety and efficacy of all forms of treatment is desirable,” they wrote, noting some of that research is underway.

“However, we believe physicians would fall short in their duty of care if they withheld hormonal treatment of gender dysphoria/incongruence in pubertal youth, when indicated, given the existing state of knowledge, imperfect though it is.”
 

Research to validate safety and efficacy of transgender TX underway

Rosenthal’s center at UCSF is one of four in the United States that has been carrying out a National Institutes of Health-funded long-term observational study of the impact of early medical intervention on transgender adolescents.

It will take time to get those results, but in the meantime, clinicians should act on what is known now, said Rosenthal.

“We already have very compelling data to suggest that the benefits [of treatment] outweigh the potential harms,” he said.

Rosenthal told Medscape Medical News that Laidlaw has advanced the notion that clinicians who prescribe puberty blockers are forcing those individuals into a transgender outcome.

“We don’t push anybody down any path,” he said. “The guidelines make these treatments available in a very specific subset of people who are evaluated by skilled mental health professionals,” said Rosenthal.

Both he and Safer acknowledge that puberty blockers do have the potential for some harm. For instance, a frank discussion needs to happen about the likely lack of future fertility, said Rosenthal.

“Everything we do in medicine has a theoretical risk of harm,” noted Safer.

However, he said, to deny a puberty blocker to an individual approaching puberty who is distraught about growing breasts — but then to possibly have to surgically remove them later — is in itself doing harm.

“Puberty blockers are exactly the epitome of ‘do no harm’ in this case,” argued Safer.

The medications are reversible, he said, adding that they also give an individual and the family time to think through whether the adolescent is transgender, and, if yes, what they want to do in terms of taking cross-sex hormones in the future or getting other interventions.

Safer acknowledged that this doesn’t mean there aren’t still some concerns, however.

For instance, once puberty blockers — which have the potential to interfere with bone development — are started, “How much harm are you willing to risk? Maybe a couple of years is okay, but maybe 6 years is not,” he said.

“So, we do discuss how quickly...you have to get to your next decision point, whether it be to actually introduce hormones or not to introduce hormones,” he explained.
 

State proposals will have chilling effect on gender-questioning kids

Clinicians say that even if the proposals do not become law, just the fact of their existence could have a chilling effect on gender-questioning children, their families, and doctors considering whether to provide treatment.

“They’re already in a hard position,” Brady said of her patients.

“They’re coming here to seek something for a life that they’ve already not wanted to live and then we have people who are trying to put a real big block on that – I see that obviously affecting their mental health,” she observed.

“I can’t imagine how their lives would be without this care,” Brady said.

With the bills being out there, “two things can happen – one is, it can be very depressing and limiting, but it can also embolden people,” Rosenthal told Medscape Medical News.

“The people behind these things are the same people that have tried to stop our research at the National Institutes of Health (NIH),” he explained.

“These people are going to do everything they can, whether it’s to go state by state to try and exhaust us, or go to the NIH and try to get them to pull the plug on our research,” said Rosenthal.

Safer believes it’s ill-considered to try to legislate any aspect of medicine.

“The pitfalls of trying to legislate these things are myriad,” he said.

“Across all of medicine, interventions are very customized. Can you imagine a state legislature trying to legislate the optimal approach in medicines that can and cannot be given to people with diabetes? How crazy that would be,” he noted.

Rosenthal has served on an advisory panel for Endo Pharmaceuticals and is a grantee of the NIH. Safer has also served on an advisory panel for Endo Pharmaceuticals. Brady has reported no relevant financial relationships.

This article first appeared on Medscape.com.

Many US endocrinologists are crying foul as a growing number of state lawmakers are attempting to enact legislation that would prohibit, and in some cases criminalize, medical treatment for minors with gender dysphoria.

As of press time, 13 states had introduced such bills, and legislators in two additional states said they were drafting bills. So far, one — in South Dakota — was defeated in a Senate committee, and another, in Florida, was essentially tabled without being enacted.

They all have a common goal of preventing minors from receiving puberty blockers, cross-sex hormones, or gender-affirmation surgery.

“These things are being proposed based on a lot of misinformation,” said Stephen Rosenthal, MD, professor of pediatrics at the University of California, San Francisco (UCSF), and a past president of the Pediatric Endocrine Society.

Lawmakers “are not looking at the scientific evidence that supports current clinical practice guidelines,” Rosenthal, who treats transgender children, told Medscape Medical News.

And “People just aren’t really understanding the harm that regulating this kind of medicine would do,” stressed Cassandra Brady, MD, assistant professor of pediatric endocrinology at Vanderbilt University School of Medicine, Memphis, Tennessee.

The bills come at a time when gender identity clinics for minors around the world have seen a significant uptick in cases. And, as widely reported by Medscape Medical News, some clinicians have begun to question whether treatment decisions are outpacing science.

Queries about use of puberty blockers and cross-sex hormones have embroiled the United Kingdom’s only publicly funded Gender Identity Development Service (GIDS) in controversy, for example, with five clinicians resigning last year over concerns about overuse of the treatments.

And earlier this month, the UK National Health Service (NHS) announced an independent review of services including the use of puberty blockers and cross-sex hormones in youth with gender dysphoria.

Meanwhile, the topic has ignited debate in Sweden, where a report from the Board of Health and Welfare confirmed a 1,500% rise between 2008 and 2018 in gender dysphoria diagnoses among 13- to 17-year-olds born as girls, as detailed by The Guardian.

Indeed, there is some indication of a so-called “rapid-onset gender dysphoria” in born females who say they wish to become males and some clinicians have said this represents a “social” phenomenon.

But guidelines from US clinical organizations – including the American Academy of Pediatrics issued in 2018, the Endocrine Society as reported by Medscape Medical News in 2017, and the US Professional Association for Transgender Health (USPATH) – all support the use of medical treatment in adolescents with gender dysphoria who have received mental health evaluations from appropriately trained professionals.

More data needed but evidence to intervene is compelling

Joshua Safer, MD, FACP, FACE, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York City, says the data “even if it’s rudimentary, are convincing that there is a biological component to gender identity.”

Attempts to manipulate gender identity in people who are born intersex, for example, have uniformly failed, he noted.

Yet it’s still not known what causes gender identity – whether it might be a result of a cluster of genes or a bundle in the brain, or some other biological process – said Safer, who treats transgender adults, but not children, and is also a coauthor of the aforementioned Endocrine Society Clinical Practice Guideline on Endocrine Treatment of Gender Dysphoric/Gender Incongruent Persons.

This is an area for future research, he noted.

Nevertheless, “The data for interventions for transgender people ... is compelling,” he added, noting evidence for improved mental health morbidity among those gender-questioning people who have medical interventions.

“Those data are modest at this point and we need better data, but they do all move in the same direction,” he asserted.

Meanwhile, a large group of around 1,800 parents of transgender and nonbinary children have called on legislators to withdraw the proposals in an open letter organized by the Human Rights Campaign.

“We know better than anyone what our children need in order to thrive: access to best practice, evidence-based gender-affirming healthcare,” the parents write.

“These healthcare decisions must be made on a case-by-case basis, in careful consultation with a medical team, and with the goal of reducing the physical and emotional distress experienced by many transgender children,” they continue.

“They should not be made by politicians who think they know better than medical professionals,” they add.

The American Academy of Child and Adolescent Psychiatry has also condemned state efforts “to block access to these recognized interventions,” it said in a statement.

Proponents of laws speak of harms

Most of the state proposals portray medical interventions as harmful to minors.

Missouri’s proposed legislation labels surgical or hormonal treatment for a child under age 18 “abuse or neglect”; a physician or anyone who assists or provides for the child would be charged with a felony.

One of the first bills was introduced in South Dakota in January. House bill 1057 would have charged clinicians providing gender-affirming care in anyone under age 16 with a misdemeanor punishable by up to a year in prison and a $2,000 fine.

The bill was defeated in the Senate after the South Dakota State Medical Association and several other physicians, families, and adolescents testified against the proposal, according to the Argus Leader.

The Endocrine Society applauded the failure and noted in a statement that it “supports physicians’ ability to provide the best evidence-based treatment to their patients,” and that “these decisions should be made by the family and physician, and not dictated by policymakers.”

Jack Turban, MD, a resident physician in child and adolescent psychiatry at Massachusetts General Hospital, Boston, who conducted a pivotal study of some 26,000 transgender adults showing that early administration of puberty blockers led to lower odds of lifetime suicidal ideation, also expressed dismay over the bills in an opinion piece for the New York Times.

“The potential benefits of providing gender-affirmative care typically outweigh the minor risks associated with treatment,” wrote Turban.

“State legislators need to educate themselves about these young people and their medical care before introducing legislation that will hurt them,” he added.
 

Few states seem to have approached clinicians for feedback

In Tennessee, lawmakers have approached some clinicians at Vanderbilt and have appreciated the feedback they’ve received so far, said Brady.

But that may be an exception. It seems that few medical organizations have been consulted in the crafting of bills in the other states: Colorado, Florida, Idaho, Illinois, Kentucky, Mississippi, Missouri, New Hampshire, Oklahoma, South Carolina, South Dakota, and West Virginia. Lawmakers in Ohio and Utah also are drafting proposals.

Physicians could be charged with a felony in Florida, Idaho, Kentucky, Missouri, and reportedly, in the Ohio proposal under development.

The bills have been introduced at the behest of some conservative groups that doubt the existence of gender dysphoria or who have questions about treatment: the Eagle Forum, the Alliance Defending Freedom, and the Kelsey Coalition.

In a recent tweet clarifying its position on state efforts, the Kelsey Coalition said it “supports all bills that protect children, even those that may provide criminal penalties, because we believe these medical interventions should never be performed on children.”

“However, we do not support state bills that are not victim-led or used for political gain,” they added.
 

Existing knowledge imperfect but treatment indicated for some

The bills have also garnered support from some endocrinologists who have raised concerns about puberty blockers and other medical treatments for gender dysphoria.

One is Michael K. Laidlaw, MD, a Rocklin, California–based endocrinologist who has not treated transgender people but frequently writes about the subject, most recently calling the use of puberty blockers “a public health emergency.”

Laidlaw joined several other clinicians who do not treat transgender people in testifying in favor of the South Dakota bill.

Last year, as previously reported by Medscape Medical News, Laidlaw, along with others, criticized the Endocrine Society’s 2017 Clinical Practice Guideline on Treating Dysphoric/Gender-Incongruent Persons in a letter to the Journal of Clinical Endocrinology & Metabolism.

They stated that there is no lab, imaging, or other objective test to diagnose someone as transgender and that “the consequences of this gender-affirmative therapy are not trivial and include potential sterility, sexual dysfunction, thromboembolic and cardiovascular disease, and malignancy.”

Laidlaw told Medscape Medical News at the time that “If we’re talking about [transgender] adults [who have gone through puberty of their biological sex] and who can make a decision, if they have been truly notified of the risks and benefits [of cross-sex hormones] and have also had psychological evaluation, and they decide, ‘This is still the right course for me,’ then I don’t have any objection.”

But considering the use of cross-sex hormones in children and adolescents is “quite a different story,” he contended.

In May 2019, Rosenthal, Safer and colleagues responded to Laidlaw’s letter in the same journal, stating that for the right person, puberty blockers and cross-sex hormones are appropriate, and that medications can improve mental health outcomes.

“We agree that research to validate the safety and efficacy of all forms of treatment is desirable,” they wrote, noting some of that research is underway.

“However, we believe physicians would fall short in their duty of care if they withheld hormonal treatment of gender dysphoria/incongruence in pubertal youth, when indicated, given the existing state of knowledge, imperfect though it is.”
 

Research to validate safety and efficacy of transgender TX underway

Rosenthal’s center at UCSF is one of four in the United States that has been carrying out a National Institutes of Health-funded long-term observational study of the impact of early medical intervention on transgender adolescents.

It will take time to get those results, but in the meantime, clinicians should act on what is known now, said Rosenthal.

“We already have very compelling data to suggest that the benefits [of treatment] outweigh the potential harms,” he said.

Rosenthal told Medscape Medical News that Laidlaw has advanced the notion that clinicians who prescribe puberty blockers are forcing those individuals into a transgender outcome.

“We don’t push anybody down any path,” he said. “The guidelines make these treatments available in a very specific subset of people who are evaluated by skilled mental health professionals,” said Rosenthal.

Both he and Safer acknowledge that puberty blockers do have the potential for some harm. For instance, a frank discussion needs to happen about the likely lack of future fertility, said Rosenthal.

“Everything we do in medicine has a theoretical risk of harm,” noted Safer.

However, he said, to deny a puberty blocker to an individual approaching puberty who is distraught about growing breasts — but then to possibly have to surgically remove them later — is in itself doing harm.

“Puberty blockers are exactly the epitome of ‘do no harm’ in this case,” argued Safer.

The medications are reversible, he said, adding that they also give an individual and the family time to think through whether the adolescent is transgender, and, if yes, what they want to do in terms of taking cross-sex hormones in the future or getting other interventions.

Safer acknowledged that this doesn’t mean there aren’t still some concerns, however.

For instance, once puberty blockers — which have the potential to interfere with bone development — are started, “How much harm are you willing to risk? Maybe a couple of years is okay, but maybe 6 years is not,” he said.

“So, we do discuss how quickly...you have to get to your next decision point, whether it be to actually introduce hormones or not to introduce hormones,” he explained.
 

State proposals will have chilling effect on gender-questioning kids

Clinicians say that even if the proposals do not become law, just the fact of their existence could have a chilling effect on gender-questioning children, their families, and doctors considering whether to provide treatment.

“They’re already in a hard position,” Brady said of her patients.

“They’re coming here to seek something for a life that they’ve already not wanted to live and then we have people who are trying to put a real big block on that – I see that obviously affecting their mental health,” she observed.

“I can’t imagine how their lives would be without this care,” Brady said.

With the bills being out there, “two things can happen – one is, it can be very depressing and limiting, but it can also embolden people,” Rosenthal told Medscape Medical News.

“The people behind these things are the same people that have tried to stop our research at the National Institutes of Health (NIH),” he explained.

“These people are going to do everything they can, whether it’s to go state by state to try and exhaust us, or go to the NIH and try to get them to pull the plug on our research,” said Rosenthal.

Safer believes it’s ill-considered to try to legislate any aspect of medicine.

“The pitfalls of trying to legislate these things are myriad,” he said.

“Across all of medicine, interventions are very customized. Can you imagine a state legislature trying to legislate the optimal approach in medicines that can and cannot be given to people with diabetes? How crazy that would be,” he noted.

Rosenthal has served on an advisory panel for Endo Pharmaceuticals and is a grantee of the NIH. Safer has also served on an advisory panel for Endo Pharmaceuticals. Brady has reported no relevant financial relationships.

This article first appeared on Medscape.com.

The Trump administration can move forward with expanding a rule that makes it more difficult for immigrants to remain in the United States if they receive health care assistance, the U.S. Supreme Court ruled in a 5-4 vote.

Courtesy Fred Schilling, Collection of the Supreme Court of the United States

The Feb. 21 order allows the administration to broaden the so-called “public charge rule” while legal challenges against the expanded regulation continue in the lower courts. The Supreme Court’s decision, which lifts a preliminary injunction against the expansion, applies to enforcement only in Illinois, where a district court blocked the revised rule from moving forward in October 2019. The Supreme Court’s measure follows another 5-4 order in January, in which justices lifted a nationwide injunction against the revised rule.

Under the long-standing public charge rule, immigration officials can refuse to admit immigrants into the United States or can deny them permanent legal status if they are deemed likely to become a public charge. Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.

The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid, the Supplemental Nutrition Assistance Program, and several housing programs. Use of these programs for more than 12 months in the aggregate during a 36-month period may result in a “public charge” designation and lead to green card denial.

Eight legal challenges were immediately filed against the rule changes, including a complaint issued by 14 states. At least five trial courts have since blocked the measure, while appeals courts have lifted some of the injunctions and upheld enforcement.

In its Jan. 27 order lifting the nationwide injunction, Associate Justice Neil M. Gorsuch wrote that nationwide injunctions are being overused by trial courts with negative consequences.

“The real problem here is the increasingly common practice of trial courts ordering relief that transcends the cases before them. Whether framed as injunctions of ‘nationwide,’ ‘universal,’ or ‘cosmic’ scope, these orders share the same basic flaw – they direct how the defendant must act toward persons who are not parties to the case,” he wrote. “It has become increasingly apparent that this court must, at some point, confront these important objections to this increasingly widespread practice. As the brief and furious history of the regulation before us illustrates, the routine issuance of universal injunctions is patently unworkable, sowing chaos for litigants, the government, courts, and all those affected by these conflicting decisions.”

In the court’s Feb. 21 order lifting the injunction in Illinois, justices gave no explanation for overturning the lower court’s injunction. However, Associate Justice Sonia Sotomayor issued a sharply-worded dissent, criticizing her fellow justices for allowing the rule to proceed.

“In sum, the government’s only claimed hardship is that it must enforce an existing interpretation of an immigration rule in one state – just as it has done for the past 20 years – while an updated version of the rule takes effect in the remaining 49,” she wrote. “The government has not quantified or explained any burdens that would arise from this state of the world.”

ACA cases still in limbo

Meanwhile, the Supreme Court still has not decided whether it will hear Texas v. United States, a case that could effectively dismantle the Affordable Care Act.

The high court was expected to announce whether it would take the high-profile case at a private Feb. 21 conference, but the justices have released no update. The case was relisted for consideration at the court’s Feb. 28 conference.

Texas v. United States stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Because the Trump administration declined to defend the law, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. The Democratic attorneys general and governors appealed the decision to the U.S. Supreme Court.

If the Supreme Court agrees to hear the challenge, the court could fast-track the case and schedule arguments for the current term or wait until its next term, which starts in October 2020. If justices decline to hear the case, the challenge will remain with the district court for more analysis about the law’s severability.

Another ACA-related case – Maine Community Health Options v. U.S. – also remains in limbo. Justices heard the case, which was consolidated with two similar challenges, on Dec. 10, 2019, but still have not issued a decision.

The consolidated challenges center on whether the federal government owes insurers billions based on an Affordable Care Act provision intended to help health plans mitigate risk under the law. The ACA’s risk corridor program required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses. Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged and they want the Supreme Court to force the government to reimburse them to the tune of $12 billion.

The Department of Justice counters that the government is not required to pay the insurers because of appropriations measures passed by Congress in 2014 and in later years that limited the funding available to compensate insurers for their losses.

The federal government and insurers have each experienced wins and losses at the lower court level. Most recently, the U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.

A Supreme Court decision in the case could come as soon as Feb. 26.

Court to hear women’s health cases

Two closely watched reproductive health cases will go before the court this spring.

On March 4, justices will hear oral arguments in June Medical Services v. Russo, regarding the constitutionality of a Louisiana law that requires physicians performing abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, according to the state law, originally passed in 2014. Clinics that employ such doctors can also have their licenses revoked.

June Medical Services LLC, a women’s health clinic, sued over the law. A district court ruled in favor of the plaintiff, but the 5th U.S. Circuit Court of Appeals reversed and upheld Louisiana’s law. The clinic appealed to the U.S. Supreme Court. Louisiana officials argue the challenge should be dismissed, and the law allowed to proceed, because the plaintiffs lack standing.

The Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, justices struck down the measure as unconstitutional.

And on April 29, justices will hear arguments in Little Sisters of the Poor v. Pennsylvania, a consolidated case about whether the Trump administration acted properly when it expanded exemptions under the Affordable Care Act’s contraceptive mandate. Entities that object to providing contraception on the basis of religious beliefs can opt out of complying with the mandate, according to the 2018 regulations. Additionally, nonprofit organizations and small businesses that have nonreligious moral convictions against the mandate can skip compliance. A number of states and entities sued over the new rules.

A federal appeals court temporarily barred the regulations from moving forward, ruling the plaintiffs were likely to succeed in proving the Trump administration did not follow appropriate procedures when it promulgated the new rules and that the regulations were not authorized under the ACA.

Justices will decide whether the parties have standing in the case, whether the Trump administration followed correct rule-making procedures, and if the regulations can stand.

agallegos@mdedge.com

The Trump administration can move forward with expanding a rule that makes it more difficult for immigrants to remain in the United States if they receive health care assistance, the U.S. Supreme Court ruled in a 5-4 vote.

Courtesy Fred Schilling, Collection of the Supreme Court of the United States

The Feb. 21 order allows the administration to broaden the so-called “public charge rule” while legal challenges against the expanded regulation continue in the lower courts. The Supreme Court’s decision, which lifts a preliminary injunction against the expansion, applies to enforcement only in Illinois, where a district court blocked the revised rule from moving forward in October 2019. The Supreme Court’s measure follows another 5-4 order in January, in which justices lifted a nationwide injunction against the revised rule.

Under the long-standing public charge rule, immigration officials can refuse to admit immigrants into the United States or can deny them permanent legal status if they are deemed likely to become a public charge. Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.

The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid, the Supplemental Nutrition Assistance Program, and several housing programs. Use of these programs for more than 12 months in the aggregate during a 36-month period may result in a “public charge” designation and lead to green card denial.

Eight legal challenges were immediately filed against the rule changes, including a complaint issued by 14 states. At least five trial courts have since blocked the measure, while appeals courts have lifted some of the injunctions and upheld enforcement.

In its Jan. 27 order lifting the nationwide injunction, Associate Justice Neil M. Gorsuch wrote that nationwide injunctions are being overused by trial courts with negative consequences.

“The real problem here is the increasingly common practice of trial courts ordering relief that transcends the cases before them. Whether framed as injunctions of ‘nationwide,’ ‘universal,’ or ‘cosmic’ scope, these orders share the same basic flaw – they direct how the defendant must act toward persons who are not parties to the case,” he wrote. “It has become increasingly apparent that this court must, at some point, confront these important objections to this increasingly widespread practice. As the brief and furious history of the regulation before us illustrates, the routine issuance of universal injunctions is patently unworkable, sowing chaos for litigants, the government, courts, and all those affected by these conflicting decisions.”

In the court’s Feb. 21 order lifting the injunction in Illinois, justices gave no explanation for overturning the lower court’s injunction. However, Associate Justice Sonia Sotomayor issued a sharply-worded dissent, criticizing her fellow justices for allowing the rule to proceed.

“In sum, the government’s only claimed hardship is that it must enforce an existing interpretation of an immigration rule in one state – just as it has done for the past 20 years – while an updated version of the rule takes effect in the remaining 49,” she wrote. “The government has not quantified or explained any burdens that would arise from this state of the world.”

ACA cases still in limbo

Meanwhile, the Supreme Court still has not decided whether it will hear Texas v. United States, a case that could effectively dismantle the Affordable Care Act.

The high court was expected to announce whether it would take the high-profile case at a private Feb. 21 conference, but the justices have released no update. The case was relisted for consideration at the court’s Feb. 28 conference.

Texas v. United States stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Because the Trump administration declined to defend the law, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. The Democratic attorneys general and governors appealed the decision to the U.S. Supreme Court.

If the Supreme Court agrees to hear the challenge, the court could fast-track the case and schedule arguments for the current term or wait until its next term, which starts in October 2020. If justices decline to hear the case, the challenge will remain with the district court for more analysis about the law’s severability.

Another ACA-related case – Maine Community Health Options v. U.S. – also remains in limbo. Justices heard the case, which was consolidated with two similar challenges, on Dec. 10, 2019, but still have not issued a decision.

The consolidated challenges center on whether the federal government owes insurers billions based on an Affordable Care Act provision intended to help health plans mitigate risk under the law. The ACA’s risk corridor program required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses. Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged and they want the Supreme Court to force the government to reimburse them to the tune of $12 billion.

The Department of Justice counters that the government is not required to pay the insurers because of appropriations measures passed by Congress in 2014 and in later years that limited the funding available to compensate insurers for their losses.

The federal government and insurers have each experienced wins and losses at the lower court level. Most recently, the U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.

A Supreme Court decision in the case could come as soon as Feb. 26.

Court to hear women’s health cases

Two closely watched reproductive health cases will go before the court this spring.

On March 4, justices will hear oral arguments in June Medical Services v. Russo, regarding the constitutionality of a Louisiana law that requires physicians performing abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, according to the state law, originally passed in 2014. Clinics that employ such doctors can also have their licenses revoked.

June Medical Services LLC, a women’s health clinic, sued over the law. A district court ruled in favor of the plaintiff, but the 5th U.S. Circuit Court of Appeals reversed and upheld Louisiana’s law. The clinic appealed to the U.S. Supreme Court. Louisiana officials argue the challenge should be dismissed, and the law allowed to proceed, because the plaintiffs lack standing.

The Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, justices struck down the measure as unconstitutional.

And on April 29, justices will hear arguments in Little Sisters of the Poor v. Pennsylvania, a consolidated case about whether the Trump administration acted properly when it expanded exemptions under the Affordable Care Act’s contraceptive mandate. Entities that object to providing contraception on the basis of religious beliefs can opt out of complying with the mandate, according to the 2018 regulations. Additionally, nonprofit organizations and small businesses that have nonreligious moral convictions against the mandate can skip compliance. A number of states and entities sued over the new rules.

A federal appeals court temporarily barred the regulations from moving forward, ruling the plaintiffs were likely to succeed in proving the Trump administration did not follow appropriate procedures when it promulgated the new rules and that the regulations were not authorized under the ACA.

Justices will decide whether the parties have standing in the case, whether the Trump administration followed correct rule-making procedures, and if the regulations can stand.

agallegos@mdedge.com

The Trump administration can move forward with expanding a rule that makes it more difficult for immigrants to remain in the United States if they receive health care assistance, the U.S. Supreme Court ruled in a 5-4 vote.

Courtesy Fred Schilling, Collection of the Supreme Court of the United States

The Feb. 21 order allows the administration to broaden the so-called “public charge rule” while legal challenges against the expanded regulation continue in the lower courts. The Supreme Court’s decision, which lifts a preliminary injunction against the expansion, applies to enforcement only in Illinois, where a district court blocked the revised rule from moving forward in October 2019. The Supreme Court’s measure follows another 5-4 order in January, in which justices lifted a nationwide injunction against the revised rule.

Under the long-standing public charge rule, immigration officials can refuse to admit immigrants into the United States or can deny them permanent legal status if they are deemed likely to become a public charge. Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.

The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid, the Supplemental Nutrition Assistance Program, and several housing programs. Use of these programs for more than 12 months in the aggregate during a 36-month period may result in a “public charge” designation and lead to green card denial.

Eight legal challenges were immediately filed against the rule changes, including a complaint issued by 14 states. At least five trial courts have since blocked the measure, while appeals courts have lifted some of the injunctions and upheld enforcement.

In its Jan. 27 order lifting the nationwide injunction, Associate Justice Neil M. Gorsuch wrote that nationwide injunctions are being overused by trial courts with negative consequences.

“The real problem here is the increasingly common practice of trial courts ordering relief that transcends the cases before them. Whether framed as injunctions of ‘nationwide,’ ‘universal,’ or ‘cosmic’ scope, these orders share the same basic flaw – they direct how the defendant must act toward persons who are not parties to the case,” he wrote. “It has become increasingly apparent that this court must, at some point, confront these important objections to this increasingly widespread practice. As the brief and furious history of the regulation before us illustrates, the routine issuance of universal injunctions is patently unworkable, sowing chaos for litigants, the government, courts, and all those affected by these conflicting decisions.”

In the court’s Feb. 21 order lifting the injunction in Illinois, justices gave no explanation for overturning the lower court’s injunction. However, Associate Justice Sonia Sotomayor issued a sharply-worded dissent, criticizing her fellow justices for allowing the rule to proceed.

“In sum, the government’s only claimed hardship is that it must enforce an existing interpretation of an immigration rule in one state – just as it has done for the past 20 years – while an updated version of the rule takes effect in the remaining 49,” she wrote. “The government has not quantified or explained any burdens that would arise from this state of the world.”

ACA cases still in limbo

Meanwhile, the Supreme Court still has not decided whether it will hear Texas v. United States, a case that could effectively dismantle the Affordable Care Act.

The high court was expected to announce whether it would take the high-profile case at a private Feb. 21 conference, but the justices have released no update. The case was relisted for consideration at the court’s Feb. 28 conference.

Texas v. United States stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Because the Trump administration declined to defend the law, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. The Democratic attorneys general and governors appealed the decision to the U.S. Supreme Court.

If the Supreme Court agrees to hear the challenge, the court could fast-track the case and schedule arguments for the current term or wait until its next term, which starts in October 2020. If justices decline to hear the case, the challenge will remain with the district court for more analysis about the law’s severability.

Another ACA-related case – Maine Community Health Options v. U.S. – also remains in limbo. Justices heard the case, which was consolidated with two similar challenges, on Dec. 10, 2019, but still have not issued a decision.

The consolidated challenges center on whether the federal government owes insurers billions based on an Affordable Care Act provision intended to help health plans mitigate risk under the law. The ACA’s risk corridor program required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses. Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged and they want the Supreme Court to force the government to reimburse them to the tune of $12 billion.

The Department of Justice counters that the government is not required to pay the insurers because of appropriations measures passed by Congress in 2014 and in later years that limited the funding available to compensate insurers for their losses.

The federal government and insurers have each experienced wins and losses at the lower court level. Most recently, the U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.

A Supreme Court decision in the case could come as soon as Feb. 26.

Court to hear women’s health cases

Two closely watched reproductive health cases will go before the court this spring.

On March 4, justices will hear oral arguments in June Medical Services v. Russo, regarding the constitutionality of a Louisiana law that requires physicians performing abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, according to the state law, originally passed in 2014. Clinics that employ such doctors can also have their licenses revoked.

June Medical Services LLC, a women’s health clinic, sued over the law. A district court ruled in favor of the plaintiff, but the 5th U.S. Circuit Court of Appeals reversed and upheld Louisiana’s law. The clinic appealed to the U.S. Supreme Court. Louisiana officials argue the challenge should be dismissed, and the law allowed to proceed, because the plaintiffs lack standing.

The Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, justices struck down the measure as unconstitutional.

And on April 29, justices will hear arguments in Little Sisters of the Poor v. Pennsylvania, a consolidated case about whether the Trump administration acted properly when it expanded exemptions under the Affordable Care Act’s contraceptive mandate. Entities that object to providing contraception on the basis of religious beliefs can opt out of complying with the mandate, according to the 2018 regulations. Additionally, nonprofit organizations and small businesses that have nonreligious moral convictions against the mandate can skip compliance. A number of states and entities sued over the new rules.

A federal appeals court temporarily barred the regulations from moving forward, ruling the plaintiffs were likely to succeed in proving the Trump administration did not follow appropriate procedures when it promulgated the new rules and that the regulations were not authorized under the ACA.

Justices will decide whether the parties have standing in the case, whether the Trump administration followed correct rule-making procedures, and if the regulations can stand.

agallegos@mdedge.com

Bempedoic acid, the first agent in a new class of drugs that reduce LDL cholesterol, received Food and Drug Administration approval on Feb. 21 for treating selected hypercholesterolemic patients and is a welcome addition to the medicine cabinet, say lipid experts.

MDedge News

However, it is a tertiary option at least until results from a 14,000 patient clinical-outcome trial of bempedoic acid come out, likely in 2022, they agreed.

“I’m excited to have a new tool in the toolkit for treating high-risk patients, but I will always reach first for the drugs proven to reduce clinical outcomes,” said Erin D. Michos, MD, director of Women’s Cardiovascular Health and associate director of Preventive Cardiology at Johns Hopkins Medicine in Baltimore. That sentiment, shared by other experts, should for the time being relegate bempedoic acid (Nexletol) to a backup role behind statins, ezetimibe, and the PCSK9 inhibitor antibodies that are all now on the U.S. market and all buttressed with evidence of their ability to cut cardiovascular disease death and other CVD outcomes from large outcome studies.

The existing evidence base for bempedoic acid rests primarily two multicenter, randomized, placebo-controlled clinical trials of bempedoic acid in patients with LDL levels above 70 mg/dL while on maximally tolerated lipid-lowering therapy. In CLEAR Harmony, results showed that treatment with bempedoic acid cut LDL-cholesterol levels by an average of 18% more compared with placebo (N Engl J Med 2019;380:1022-32). In CLEAR Wisdom, bempedoic acid reduced LDL cholesterol levels by 17% (JAMA. 2019;322[18]:1780-8).

While those two trials proved the drug’s ability to lower levels of LDL cholesterol, they lacked the power to address whether this effect cut the incidence of CVD events, a question that the CLEAR Outcomes trial aims to answer.

“I believe in the lipid hypothesis, but the main thing we need to see is whether bempedoic acid leads to a meaningful reduction in CVD events. The window for bempedoic acid will remain narrow until we see the outcomes results,” Dr. Michos said in an interview.

Bempedoic acid is a prodrug that’s activated in liver and targets the same cholesterol synthesis pathway as statins by inhibition of ATP-citrate lyase, an enzyme that’s upstream of HMG-CoA reductase, thereby enhancing LDL cholesterol clearance via up-regulation of LDL receptors

.

Combined treatment with bempedoic acid and ezetimibe “may be successful in avoiding [using] a PCSK9 inhibitor in some patients, and in particular patients with HeFH or those who are statin intolerant.” But like his colleagues, Dr. Eckel agreed that, for the moment, ezetimibe has an edge over bempedoic acid because of its more extensive evidence base. “If the combination of bempedoic acid and ezetimibe is not needed, the decision [of which one of these to use] needs to depend on the outcome trial results for ezetimibe,” he said. Other factors clinicians could apply if faced with choosing between these two agents include the significant reduction in high-sensitivity C-reactive protein that bempedoic acid produces; the downside that bempedoic acid can cause in some patients an early and persistent rise in serum uric acid levels that can trigger gout flares in patients with a history of gout or at risk for gout; and cost, he said.

Cost is the room-dwelling elephant that colors many decisions about which lipid-lowering drug to use for patients, with options running the price gamut from the generic and uniformly affordable statins and ezetimibe, to the notoriously pricey PCSK9 inhibitors that remain for many patients either prohibitively expensive or hard to get covered by some insurers. Bempedoic acid seems on track to fall somewhere between these two poles, although staff members from Esperion, the company that developed and will market bempedoic acid as Nexletol starting on March 30, declared in a conference call on Feb. 24 that “cost will not be an issue,” for indicated patients prescribed the drug. Company representatives cited a program of coupons, discounts, and rebates they have planned that they anticipate will allow patients who meet the labeled indications to have an out-of-pocket cost for bempedoic acid of “as low as” $10 for a 90-pill supply. They also noted their goal of getting bempedoic acid onto the lowest tier of the Medicare formulary.

How these steps actually play out in the fun house of U.S. prescription drug pricing and preauthorizations remains to be seen. “Out-of-pocket costs are not the real drivers” of drug access, noted Dr. Robinson. “Insurers will likely start with restricted access and prior authorization requirements, just as they did with ezetimibe when it was on patent and prior to having the results from a CVD outcomes trial.” For the time being, bempedoic acid can generally be seen as “expensive ezetimibe,” summed up Dr. Robinson.

Despite that somewhat dismissive characterization, experts are intrigued by the possibility of combining two moderately potent, oral, and safe lipid-lowering drugs in selected patients as a potential alternative to the still financially challenging PCSK9 inhibitors. Combining bempedoic acid and ezetimibe “has a lot of appeal,” said Dr. Michos. “Even though preauthorization has gotten better, it’s still a challenge to get a PCSK9 inhibitor approved.”

Much of her enthusiasm stems from a study reported last year that randomized 301 patients to treatment with bempedoic acid, ezetimibe, or both. The results showed that combined treatment has a similar safety profile to treatment with either drug alone, and produced a cut in LDL cholesterol that was roughly additive for the reductions produced by each drug by itself: Ezetimibe alone cut LDL by about 23%, bempedoic acid alone by about 17%, and the two dosed together once daily resulted in an average 36% drop (Eur J Prev Cardiol. 2019 Jul 29. doi: 10.1177/2047487319864671). The results showed that, “in patients requiring intensive LDL cholesterol lowering, who cannot afford PCSK9 inhibitors, or have statin intolerance, bempedoic acid and ezetimibe are stronger together and can serve as an alternative approach for lipid management in ASCVD prevention,” wrote Dr. Michos and a coauthor in a commentary that appeared with the study results (Eur J Prev Cardiol. 2019 Jul 29. doi: 10.1177/2047487319864672).

The concept of combined bempedoic acid and ezetimibe treatment is so appealing that the bempedoic acid manufacturer, Esperion, has already developed a single-pill formulation of the two drugs that received FDA marketing approval on February 26. A company statement said that marketing of this combined formulation, Nexlizet, will start in July 2020.

Although interest in bempedoic acid seems running high for patients included in the new FDA indication, Dr. Michos and others see possibly greater potential for what would now be off-label use for primary prevention in high-risk patients without HeFH, patients who generally don’t qualify for insurance coverage of a PCSK9 inhibitor.

“Use in primary prevention in [non-HeFH] patients with insufficient lowering of LDL cholesterol wouldn’t surprise me,” but a big concern will be out-of-pocket cost when off-label use precludes insurance coverage or discount eligibility, noted Dr. Eckel. An Esperion spokesperson said that the undiscounted, wholesale acquisition cost for bempedoic acid is expected to be roughly $10/pill, or about $300 for a 30-day supply, positioning it more or less midway between generic statins and ezetimibe and the list price for a PCSk9 inhibitor of roughly $500/month.

“I’m most excited about bempedoic acid in the off-label space, for patients who can’t get approved for a PCSK9 inhibitor, for treating patients with subclinical ASCVD, or really high-risk patients with multiple risk factors including diabetes,” especially when these patients are intolerant of a high-intensity statin regimen, said Dr. Michos. “I have a clinic full of patients” who can’t take their full, indicated dosage of a high-intensity statin, and when those patients also can’t get on treatment with a PCSK9 inhibitor then bempedoic acid will be an important part of their alternative regimen, she explained.

Dr. Michos had no disclosures. Dr. Robinson has received research funding from Esperion and from several other companies, and she has been a consultant to Amgen, Merck, Novartis, Novo Nordisk, Pfizer, Regeneron, and Sanofi. Dr. Eckel has received honoraria from Kowa, Merck, Novo Nordisk, and Sanofi/Regeneron.

This article was updated 2/27/20.

mzoler@mdedge.com

Bempedoic acid, the first agent in a new class of drugs that reduce LDL cholesterol, received Food and Drug Administration approval on Feb. 21 for treating selected hypercholesterolemic patients and is a welcome addition to the medicine cabinet, say lipid experts.

MDedge News

However, it is a tertiary option at least until results from a 14,000 patient clinical-outcome trial of bempedoic acid come out, likely in 2022, they agreed.

“I’m excited to have a new tool in the toolkit for treating high-risk patients, but I will always reach first for the drugs proven to reduce clinical outcomes,” said Erin D. Michos, MD, director of Women’s Cardiovascular Health and associate director of Preventive Cardiology at Johns Hopkins Medicine in Baltimore. That sentiment, shared by other experts, should for the time being relegate bempedoic acid (Nexletol) to a backup role behind statins, ezetimibe, and the PCSK9 inhibitor antibodies that are all now on the U.S. market and all buttressed with evidence of their ability to cut cardiovascular disease death and other CVD outcomes from large outcome studies.

The existing evidence base for bempedoic acid rests primarily two multicenter, randomized, placebo-controlled clinical trials of bempedoic acid in patients with LDL levels above 70 mg/dL while on maximally tolerated lipid-lowering therapy. In CLEAR Harmony, results showed that treatment with bempedoic acid cut LDL-cholesterol levels by an average of 18% more compared with placebo (N Engl J Med 2019;380:1022-32). In CLEAR Wisdom, bempedoic acid reduced LDL cholesterol levels by 17% (JAMA. 2019;322[18]:1780-8).

While those two trials proved the drug’s ability to lower levels of LDL cholesterol, they lacked the power to address whether this effect cut the incidence of CVD events, a question that the CLEAR Outcomes trial aims to answer.

“I believe in the lipid hypothesis, but the main thing we need to see is whether bempedoic acid leads to a meaningful reduction in CVD events. The window for bempedoic acid will remain narrow until we see the outcomes results,” Dr. Michos said in an interview.

Bempedoic acid is a prodrug that’s activated in liver and targets the same cholesterol synthesis pathway as statins by inhibition of ATP-citrate lyase, an enzyme that’s upstream of HMG-CoA reductase, thereby enhancing LDL cholesterol clearance via up-regulation of LDL receptors

.

Combined treatment with bempedoic acid and ezetimibe “may be successful in avoiding [using] a PCSK9 inhibitor in some patients, and in particular patients with HeFH or those who are statin intolerant.” But like his colleagues, Dr. Eckel agreed that, for the moment, ezetimibe has an edge over bempedoic acid because of its more extensive evidence base. “If the combination of bempedoic acid and ezetimibe is not needed, the decision [of which one of these to use] needs to depend on the outcome trial results for ezetimibe,” he said. Other factors clinicians could apply if faced with choosing between these two agents include the significant reduction in high-sensitivity C-reactive protein that bempedoic acid produces; the downside that bempedoic acid can cause in some patients an early and persistent rise in serum uric acid levels that can trigger gout flares in patients with a history of gout or at risk for gout; and cost, he said.

Cost is the room-dwelling elephant that colors many decisions about which lipid-lowering drug to use for patients, with options running the price gamut from the generic and uniformly affordable statins and ezetimibe, to the notoriously pricey PCSK9 inhibitors that remain for many patients either prohibitively expensive or hard to get covered by some insurers. Bempedoic acid seems on track to fall somewhere between these two poles, although staff members from Esperion, the company that developed and will market bempedoic acid as Nexletol starting on March 30, declared in a conference call on Feb. 24 that “cost will not be an issue,” for indicated patients prescribed the drug. Company representatives cited a program of coupons, discounts, and rebates they have planned that they anticipate will allow patients who meet the labeled indications to have an out-of-pocket cost for bempedoic acid of “as low as” $10 for a 90-pill supply. They also noted their goal of getting bempedoic acid onto the lowest tier of the Medicare formulary.

How these steps actually play out in the fun house of U.S. prescription drug pricing and preauthorizations remains to be seen. “Out-of-pocket costs are not the real drivers” of drug access, noted Dr. Robinson. “Insurers will likely start with restricted access and prior authorization requirements, just as they did with ezetimibe when it was on patent and prior to having the results from a CVD outcomes trial.” For the time being, bempedoic acid can generally be seen as “expensive ezetimibe,” summed up Dr. Robinson.

Despite that somewhat dismissive characterization, experts are intrigued by the possibility of combining two moderately potent, oral, and safe lipid-lowering drugs in selected patients as a potential alternative to the still financially challenging PCSK9 inhibitors. Combining bempedoic acid and ezetimibe “has a lot of appeal,” said Dr. Michos. “Even though preauthorization has gotten better, it’s still a challenge to get a PCSK9 inhibitor approved.”

Much of her enthusiasm stems from a study reported last year that randomized 301 patients to treatment with bempedoic acid, ezetimibe, or both. The results showed that combined treatment has a similar safety profile to treatment with either drug alone, and produced a cut in LDL cholesterol that was roughly additive for the reductions produced by each drug by itself: Ezetimibe alone cut LDL by about 23%, bempedoic acid alone by about 17%, and the two dosed together once daily resulted in an average 36% drop (Eur J Prev Cardiol. 2019 Jul 29. doi: 10.1177/2047487319864671). The results showed that, “in patients requiring intensive LDL cholesterol lowering, who cannot afford PCSK9 inhibitors, or have statin intolerance, bempedoic acid and ezetimibe are stronger together and can serve as an alternative approach for lipid management in ASCVD prevention,” wrote Dr. Michos and a coauthor in a commentary that appeared with the study results (Eur J Prev Cardiol. 2019 Jul 29. doi: 10.1177/2047487319864672).

The concept of combined bempedoic acid and ezetimibe treatment is so appealing that the bempedoic acid manufacturer, Esperion, has already developed a single-pill formulation of the two drugs that received FDA marketing approval on February 26. A company statement said that marketing of this combined formulation, Nexlizet, will start in July 2020.

Although interest in bempedoic acid seems running high for patients included in the new FDA indication, Dr. Michos and others see possibly greater potential for what would now be off-label use for primary prevention in high-risk patients without HeFH, patients who generally don’t qualify for insurance coverage of a PCSK9 inhibitor.

“Use in primary prevention in [non-HeFH] patients with insufficient lowering of LDL cholesterol wouldn’t surprise me,” but a big concern will be out-of-pocket cost when off-label use precludes insurance coverage or discount eligibility, noted Dr. Eckel. An Esperion spokesperson said that the undiscounted, wholesale acquisition cost for bempedoic acid is expected to be roughly $10/pill, or about $300 for a 30-day supply, positioning it more or less midway between generic statins and ezetimibe and the list price for a PCSk9 inhibitor of roughly $500/month.

“I’m most excited about bempedoic acid in the off-label space, for patients who can’t get approved for a PCSK9 inhibitor, for treating patients with subclinical ASCVD, or really high-risk patients with multiple risk factors including diabetes,” especially when these patients are intolerant of a high-intensity statin regimen, said Dr. Michos. “I have a clinic full of patients” who can’t take their full, indicated dosage of a high-intensity statin, and when those patients also can’t get on treatment with a PCSK9 inhibitor then bempedoic acid will be an important part of their alternative regimen, she explained.

Dr. Michos had no disclosures. Dr. Robinson has received research funding from Esperion and from several other companies, and she has been a consultant to Amgen, Merck, Novartis, Novo Nordisk, Pfizer, Regeneron, and Sanofi. Dr. Eckel has received honoraria from Kowa, Merck, Novo Nordisk, and Sanofi/Regeneron.

This article was updated 2/27/20.

mzoler@mdedge.com

Bempedoic acid, the first agent in a new class of drugs that reduce LDL cholesterol, received Food and Drug Administration approval on Feb. 21 for treating selected hypercholesterolemic patients and is a welcome addition to the medicine cabinet, say lipid experts.

MDedge News

However, it is a tertiary option at least until results from a 14,000 patient clinical-outcome trial of bempedoic acid come out, likely in 2022, they agreed.

“I’m excited to have a new tool in the toolkit for treating high-risk patients, but I will always reach first for the drugs proven to reduce clinical outcomes,” said Erin D. Michos, MD, director of Women’s Cardiovascular Health and associate director of Preventive Cardiology at Johns Hopkins Medicine in Baltimore. That sentiment, shared by other experts, should for the time being relegate bempedoic acid (Nexletol) to a backup role behind statins, ezetimibe, and the PCSK9 inhibitor antibodies that are all now on the U.S. market and all buttressed with evidence of their ability to cut cardiovascular disease death and other CVD outcomes from large outcome studies.

The existing evidence base for bempedoic acid rests primarily two multicenter, randomized, placebo-controlled clinical trials of bempedoic acid in patients with LDL levels above 70 mg/dL while on maximally tolerated lipid-lowering therapy. In CLEAR Harmony, results showed that treatment with bempedoic acid cut LDL-cholesterol levels by an average of 18% more compared with placebo (N Engl J Med 2019;380:1022-32). In CLEAR Wisdom, bempedoic acid reduced LDL cholesterol levels by 17% (JAMA. 2019;322[18]:1780-8).

While those two trials proved the drug’s ability to lower levels of LDL cholesterol, they lacked the power to address whether this effect cut the incidence of CVD events, a question that the CLEAR Outcomes trial aims to answer.

“I believe in the lipid hypothesis, but the main thing we need to see is whether bempedoic acid leads to a meaningful reduction in CVD events. The window for bempedoic acid will remain narrow until we see the outcomes results,” Dr. Michos said in an interview.

Bempedoic acid is a prodrug that’s activated in liver and targets the same cholesterol synthesis pathway as statins by inhibition of ATP-citrate lyase, an enzyme that’s upstream of HMG-CoA reductase, thereby enhancing LDL cholesterol clearance via up-regulation of LDL receptors

.

Combined treatment with bempedoic acid and ezetimibe “may be successful in avoiding [using] a PCSK9 inhibitor in some patients, and in particular patients with HeFH or those who are statin intolerant.” But like his colleagues, Dr. Eckel agreed that, for the moment, ezetimibe has an edge over bempedoic acid because of its more extensive evidence base. “If the combination of bempedoic acid and ezetimibe is not needed, the decision [of which one of these to use] needs to depend on the outcome trial results for ezetimibe,” he said. Other factors clinicians could apply if faced with choosing between these two agents include the significant reduction in high-sensitivity C-reactive protein that bempedoic acid produces; the downside that bempedoic acid can cause in some patients an early and persistent rise in serum uric acid levels that can trigger gout flares in patients with a history of gout or at risk for gout; and cost, he said.

Cost is the room-dwelling elephant that colors many decisions about which lipid-lowering drug to use for patients, with options running the price gamut from the generic and uniformly affordable statins and ezetimibe, to the notoriously pricey PCSK9 inhibitors that remain for many patients either prohibitively expensive or hard to get covered by some insurers. Bempedoic acid seems on track to fall somewhere between these two poles, although staff members from Esperion, the company that developed and will market bempedoic acid as Nexletol starting on March 30, declared in a conference call on Feb. 24 that “cost will not be an issue,” for indicated patients prescribed the drug. Company representatives cited a program of coupons, discounts, and rebates they have planned that they anticipate will allow patients who meet the labeled indications to have an out-of-pocket cost for bempedoic acid of “as low as” $10 for a 90-pill supply. They also noted their goal of getting bempedoic acid onto the lowest tier of the Medicare formulary.

How these steps actually play out in the fun house of U.S. prescription drug pricing and preauthorizations remains to be seen. “Out-of-pocket costs are not the real drivers” of drug access, noted Dr. Robinson. “Insurers will likely start with restricted access and prior authorization requirements, just as they did with ezetimibe when it was on patent and prior to having the results from a CVD outcomes trial.” For the time being, bempedoic acid can generally be seen as “expensive ezetimibe,” summed up Dr. Robinson.

Despite that somewhat dismissive characterization, experts are intrigued by the possibility of combining two moderately potent, oral, and safe lipid-lowering drugs in selected patients as a potential alternative to the still financially challenging PCSK9 inhibitors. Combining bempedoic acid and ezetimibe “has a lot of appeal,” said Dr. Michos. “Even though preauthorization has gotten better, it’s still a challenge to get a PCSK9 inhibitor approved.”

Much of her enthusiasm stems from a study reported last year that randomized 301 patients to treatment with bempedoic acid, ezetimibe, or both. The results showed that combined treatment has a similar safety profile to treatment with either drug alone, and produced a cut in LDL cholesterol that was roughly additive for the reductions produced by each drug by itself: Ezetimibe alone cut LDL by about 23%, bempedoic acid alone by about 17%, and the two dosed together once daily resulted in an average 36% drop (Eur J Prev Cardiol. 2019 Jul 29. doi: 10.1177/2047487319864671). The results showed that, “in patients requiring intensive LDL cholesterol lowering, who cannot afford PCSK9 inhibitors, or have statin intolerance, bempedoic acid and ezetimibe are stronger together and can serve as an alternative approach for lipid management in ASCVD prevention,” wrote Dr. Michos and a coauthor in a commentary that appeared with the study results (Eur J Prev Cardiol. 2019 Jul 29. doi: 10.1177/2047487319864672).

The concept of combined bempedoic acid and ezetimibe treatment is so appealing that the bempedoic acid manufacturer, Esperion, has already developed a single-pill formulation of the two drugs that received FDA marketing approval on February 26. A company statement said that marketing of this combined formulation, Nexlizet, will start in July 2020.

Although interest in bempedoic acid seems running high for patients included in the new FDA indication, Dr. Michos and others see possibly greater potential for what would now be off-label use for primary prevention in high-risk patients without HeFH, patients who generally don’t qualify for insurance coverage of a PCSK9 inhibitor.

“Use in primary prevention in [non-HeFH] patients with insufficient lowering of LDL cholesterol wouldn’t surprise me,” but a big concern will be out-of-pocket cost when off-label use precludes insurance coverage or discount eligibility, noted Dr. Eckel. An Esperion spokesperson said that the undiscounted, wholesale acquisition cost for bempedoic acid is expected to be roughly $10/pill, or about $300 for a 30-day supply, positioning it more or less midway between generic statins and ezetimibe and the list price for a PCSk9 inhibitor of roughly $500/month.

“I’m most excited about bempedoic acid in the off-label space, for patients who can’t get approved for a PCSK9 inhibitor, for treating patients with subclinical ASCVD, or really high-risk patients with multiple risk factors including diabetes,” especially when these patients are intolerant of a high-intensity statin regimen, said Dr. Michos. “I have a clinic full of patients” who can’t take their full, indicated dosage of a high-intensity statin, and when those patients also can’t get on treatment with a PCSK9 inhibitor then bempedoic acid will be an important part of their alternative regimen, she explained.

Dr. Michos had no disclosures. Dr. Robinson has received research funding from Esperion and from several other companies, and she has been a consultant to Amgen, Merck, Novartis, Novo Nordisk, Pfizer, Regeneron, and Sanofi. Dr. Eckel has received honoraria from Kowa, Merck, Novo Nordisk, and Sanofi/Regeneron.

This article was updated 2/27/20.

mzoler@mdedge.com

The Centers for Medicare and Medicaid Services (CMS) finalized a new regulation requiring all hospitals participating in its programs to establish antimicrobial stewardship programs by March 30, 2020 (https://federalregister.gov/d/2019-20736). This welcome action was prompted by the rise in antimicrobial resistance; recent Centers for Disease Control and Prevention estimates more than 2.8 million antibiotic-resistant infections with more than 35,000 deaths occur in the United States each year (https://www.cdc.gov/drugresistance/biggest-threats.html). CMS recommended that hospitals follow stewardship guidelines established by CDC, and other nationally recognized sources (https://www.cdc.gov/antibiotic-use/healthcare/pdfs/hospital-core-elements-H.pdf). Antibiotic stewardship includes optimization of several aspects of antimicrobial therapy including the drugs, formulations, doses, and dosing intervals. It also includes obtaining and updating local, regional, and national susceptibility data to provide regularly updated guidance regarding diagnosis and therapy.

How does this new CMS rule affect gastroenterologists and what role, if any, do we play in the epidemic of antibiotic resistance? The one infectious disease that gastroenterology effectively owns is Helicobacter pylori. Treatment of this disease has the potential to be involved in the epidemic of antimicrobial resistance. Current H. pylori therapies were largely devised without considering the principles of antibiotic stewardship. Therapies for H. pylori have largely been developed using trial and error, antimicrobial susceptibility testing is rarely available, and local and regional susceptibility are not readily available or updated. Current national treatment recommendations are most often based on comparisons of regimens grouping trials containing different drugs, doses, and durations of therapy performed in populations in whom resistance was neither assessed nor taken into account. Finally, some of the most highly recommended effective regimens inevitably contain at least one antibiotic unnecessary for the outcome, and inadvertently serve to increase population antibiotic exposure.

Clarithromycin-amoxicillin-PPI triple is still the most often used legacy therapy in the United States with an average cure rate of 70%. Recent guidelines have suggested adding a fourth drug, metronidazole to produce a quadruple therapy (concomitant therapy); the premise is that although both clarithromycin and metronidazole resistance are common, dual resistance is not. However, this benefit comes at the price of every patient receiving at least one unnecessary antibiotic, and patients with treatment failures receiving three unnecessary antibiotics. The cumulative effect given the approximately 2 million treatments annually is 10s of thousands of kilograms of inappropriate antibiotic use annually with the likely consequence of increasing resistance.

How to move forward? The CDC documents regarding antimicrobial stewardship in hospitals with limited resources (https://www.cdc.gov/antibiotic-use/core-elements/resource-limited.html) suggest creation and promotion of evidence-based treatment guidelines for common clinical syndromes, tracking of antibiotic dispensing using available data, setting of national targets for improvement, and description of resistance patterns to improve treatment guidelines and identify priority pathogens. The CDC documents require creation and promotion of evidence-and susceptibility-based treatment guidelines, tracking of antibiotic dispensing and setting targets for improvement (i.e., monitoring and reporting). It is important to note that the CMS rule focused on hospitals as hospitals have traditionally been the sites where local susceptibility data are obtained and gathered to provide the regional data and updated treatment guidelines used to treat most infectious diseases.

The Houston Consensus Conference on Testing for Helicobacter pylori Infection in the United States in 2017 had several recommendations that would effectively address the CMS rule and CDC recommendations. For example, statement 15: that empiric eradication therapy for H. pylori be based on region or population-specific antibiotic susceptibility data (Grade 1B); Statement 17: that validated diagnostic testing of stool or gastric mucosal biopsy by culture and susceptibility, or molecular analysis be universally available (Grade 1); Statement 18: that antibiotics that may be routinely evaluated for susceptibility include amoxicillin, clarithromycin, levofloxacin, metronidazole, and tetracycline. (Grade 2C); and Statement 19: that professional societies provide the research needed to support evidence-based reimbursement decisions for antibiotic susceptibility testing for H. pylori (Grade 1).

Organized gastroenterology needs to join with the infectious disease community to make H. pylori an infection of joint interest. Mass eradication of H. pylori worldwide offers the promise of elimination of gastric cancer. The CMS rule should ultimately result in significant changes in the approach of treating H. pylori infections that includes improved testing and availability and implementation of knowledge of local susceptibility and resistance patterns. Therapies that reliably cure H. pylori without unnecessary antibiotics need to be used whereas regimens that fail to reliably achieve high cure rates should be abandoned. We should consider establishing quality metrics related to appropriate diagnostic testing for both the initial infection as well as posttreatment evaluations. We must add our voice to advocate for hospitals and central laboratories to offer susceptibility testing locally or as a send out for clinicians to provide locally relevant antimicrobial therapy for H. pylori infections. The CMS rule provides both the impetus and the methods to move forward and deal with H. pylori like other infectious diseases.
 

Dr. Graham is a professor of medicine, Baylor College of Medicine, Houston; Dr. El-Serag is chair of the department of medicine at Baylor College of Medicine, Houston. Neither had conflicts of interest related to this comment.

The Centers for Medicare and Medicaid Services (CMS) finalized a new regulation requiring all hospitals participating in its programs to establish antimicrobial stewardship programs by March 30, 2020 (https://federalregister.gov/d/2019-20736). This welcome action was prompted by the rise in antimicrobial resistance; recent Centers for Disease Control and Prevention estimates more than 2.8 million antibiotic-resistant infections with more than 35,000 deaths occur in the United States each year (https://www.cdc.gov/drugresistance/biggest-threats.html). CMS recommended that hospitals follow stewardship guidelines established by CDC, and other nationally recognized sources (https://www.cdc.gov/antibiotic-use/healthcare/pdfs/hospital-core-elements-H.pdf). Antibiotic stewardship includes optimization of several aspects of antimicrobial therapy including the drugs, formulations, doses, and dosing intervals. It also includes obtaining and updating local, regional, and national susceptibility data to provide regularly updated guidance regarding diagnosis and therapy.

How does this new CMS rule affect gastroenterologists and what role, if any, do we play in the epidemic of antibiotic resistance? The one infectious disease that gastroenterology effectively owns is Helicobacter pylori. Treatment of this disease has the potential to be involved in the epidemic of antimicrobial resistance. Current H. pylori therapies were largely devised without considering the principles of antibiotic stewardship. Therapies for H. pylori have largely been developed using trial and error, antimicrobial susceptibility testing is rarely available, and local and regional susceptibility are not readily available or updated. Current national treatment recommendations are most often based on comparisons of regimens grouping trials containing different drugs, doses, and durations of therapy performed in populations in whom resistance was neither assessed nor taken into account. Finally, some of the most highly recommended effective regimens inevitably contain at least one antibiotic unnecessary for the outcome, and inadvertently serve to increase population antibiotic exposure.

Clarithromycin-amoxicillin-PPI triple is still the most often used legacy therapy in the United States with an average cure rate of 70%. Recent guidelines have suggested adding a fourth drug, metronidazole to produce a quadruple therapy (concomitant therapy); the premise is that although both clarithromycin and metronidazole resistance are common, dual resistance is not. However, this benefit comes at the price of every patient receiving at least one unnecessary antibiotic, and patients with treatment failures receiving three unnecessary antibiotics. The cumulative effect given the approximately 2 million treatments annually is 10s of thousands of kilograms of inappropriate antibiotic use annually with the likely consequence of increasing resistance.

How to move forward? The CDC documents regarding antimicrobial stewardship in hospitals with limited resources (https://www.cdc.gov/antibiotic-use/core-elements/resource-limited.html) suggest creation and promotion of evidence-based treatment guidelines for common clinical syndromes, tracking of antibiotic dispensing using available data, setting of national targets for improvement, and description of resistance patterns to improve treatment guidelines and identify priority pathogens. The CDC documents require creation and promotion of evidence-and susceptibility-based treatment guidelines, tracking of antibiotic dispensing and setting targets for improvement (i.e., monitoring and reporting). It is important to note that the CMS rule focused on hospitals as hospitals have traditionally been the sites where local susceptibility data are obtained and gathered to provide the regional data and updated treatment guidelines used to treat most infectious diseases.

The Houston Consensus Conference on Testing for Helicobacter pylori Infection in the United States in 2017 had several recommendations that would effectively address the CMS rule and CDC recommendations. For example, statement 15: that empiric eradication therapy for H. pylori be based on region or population-specific antibiotic susceptibility data (Grade 1B); Statement 17: that validated diagnostic testing of stool or gastric mucosal biopsy by culture and susceptibility, or molecular analysis be universally available (Grade 1); Statement 18: that antibiotics that may be routinely evaluated for susceptibility include amoxicillin, clarithromycin, levofloxacin, metronidazole, and tetracycline. (Grade 2C); and Statement 19: that professional societies provide the research needed to support evidence-based reimbursement decisions for antibiotic susceptibility testing for H. pylori (Grade 1).

Organized gastroenterology needs to join with the infectious disease community to make H. pylori an infection of joint interest. Mass eradication of H. pylori worldwide offers the promise of elimination of gastric cancer. The CMS rule should ultimately result in significant changes in the approach of treating H. pylori infections that includes improved testing and availability and implementation of knowledge of local susceptibility and resistance patterns. Therapies that reliably cure H. pylori without unnecessary antibiotics need to be used whereas regimens that fail to reliably achieve high cure rates should be abandoned. We should consider establishing quality metrics related to appropriate diagnostic testing for both the initial infection as well as posttreatment evaluations. We must add our voice to advocate for hospitals and central laboratories to offer susceptibility testing locally or as a send out for clinicians to provide locally relevant antimicrobial therapy for H. pylori infections. The CMS rule provides both the impetus and the methods to move forward and deal with H. pylori like other infectious diseases.
 

Dr. Graham is a professor of medicine, Baylor College of Medicine, Houston; Dr. El-Serag is chair of the department of medicine at Baylor College of Medicine, Houston. Neither had conflicts of interest related to this comment.

The Centers for Medicare and Medicaid Services (CMS) finalized a new regulation requiring all hospitals participating in its programs to establish antimicrobial stewardship programs by March 30, 2020 (https://federalregister.gov/d/2019-20736). This welcome action was prompted by the rise in antimicrobial resistance; recent Centers for Disease Control and Prevention estimates more than 2.8 million antibiotic-resistant infections with more than 35,000 deaths occur in the United States each year (https://www.cdc.gov/drugresistance/biggest-threats.html). CMS recommended that hospitals follow stewardship guidelines established by CDC, and other nationally recognized sources (https://www.cdc.gov/antibiotic-use/healthcare/pdfs/hospital-core-elements-H.pdf). Antibiotic stewardship includes optimization of several aspects of antimicrobial therapy including the drugs, formulations, doses, and dosing intervals. It also includes obtaining and updating local, regional, and national susceptibility data to provide regularly updated guidance regarding diagnosis and therapy.

How does this new CMS rule affect gastroenterologists and what role, if any, do we play in the epidemic of antibiotic resistance? The one infectious disease that gastroenterology effectively owns is Helicobacter pylori. Treatment of this disease has the potential to be involved in the epidemic of antimicrobial resistance. Current H. pylori therapies were largely devised without considering the principles of antibiotic stewardship. Therapies for H. pylori have largely been developed using trial and error, antimicrobial susceptibility testing is rarely available, and local and regional susceptibility are not readily available or updated. Current national treatment recommendations are most often based on comparisons of regimens grouping trials containing different drugs, doses, and durations of therapy performed in populations in whom resistance was neither assessed nor taken into account. Finally, some of the most highly recommended effective regimens inevitably contain at least one antibiotic unnecessary for the outcome, and inadvertently serve to increase population antibiotic exposure.

Clarithromycin-amoxicillin-PPI triple is still the most often used legacy therapy in the United States with an average cure rate of 70%. Recent guidelines have suggested adding a fourth drug, metronidazole to produce a quadruple therapy (concomitant therapy); the premise is that although both clarithromycin and metronidazole resistance are common, dual resistance is not. However, this benefit comes at the price of every patient receiving at least one unnecessary antibiotic, and patients with treatment failures receiving three unnecessary antibiotics. The cumulative effect given the approximately 2 million treatments annually is 10s of thousands of kilograms of inappropriate antibiotic use annually with the likely consequence of increasing resistance.

How to move forward? The CDC documents regarding antimicrobial stewardship in hospitals with limited resources (https://www.cdc.gov/antibiotic-use/core-elements/resource-limited.html) suggest creation and promotion of evidence-based treatment guidelines for common clinical syndromes, tracking of antibiotic dispensing using available data, setting of national targets for improvement, and description of resistance patterns to improve treatment guidelines and identify priority pathogens. The CDC documents require creation and promotion of evidence-and susceptibility-based treatment guidelines, tracking of antibiotic dispensing and setting targets for improvement (i.e., monitoring and reporting). It is important to note that the CMS rule focused on hospitals as hospitals have traditionally been the sites where local susceptibility data are obtained and gathered to provide the regional data and updated treatment guidelines used to treat most infectious diseases.

The Houston Consensus Conference on Testing for Helicobacter pylori Infection in the United States in 2017 had several recommendations that would effectively address the CMS rule and CDC recommendations. For example, statement 15: that empiric eradication therapy for H. pylori be based on region or population-specific antibiotic susceptibility data (Grade 1B); Statement 17: that validated diagnostic testing of stool or gastric mucosal biopsy by culture and susceptibility, or molecular analysis be universally available (Grade 1); Statement 18: that antibiotics that may be routinely evaluated for susceptibility include amoxicillin, clarithromycin, levofloxacin, metronidazole, and tetracycline. (Grade 2C); and Statement 19: that professional societies provide the research needed to support evidence-based reimbursement decisions for antibiotic susceptibility testing for H. pylori (Grade 1).

Organized gastroenterology needs to join with the infectious disease community to make H. pylori an infection of joint interest. Mass eradication of H. pylori worldwide offers the promise of elimination of gastric cancer. The CMS rule should ultimately result in significant changes in the approach of treating H. pylori infections that includes improved testing and availability and implementation of knowledge of local susceptibility and resistance patterns. Therapies that reliably cure H. pylori without unnecessary antibiotics need to be used whereas regimens that fail to reliably achieve high cure rates should be abandoned. We should consider establishing quality metrics related to appropriate diagnostic testing for both the initial infection as well as posttreatment evaluations. We must add our voice to advocate for hospitals and central laboratories to offer susceptibility testing locally or as a send out for clinicians to provide locally relevant antimicrobial therapy for H. pylori infections. The CMS rule provides both the impetus and the methods to move forward and deal with H. pylori like other infectious diseases.
 

Dr. Graham is a professor of medicine, Baylor College of Medicine, Houston; Dr. El-Serag is chair of the department of medicine at Baylor College of Medicine, Houston. Neither had conflicts of interest related to this comment.